CATALYST PHARMACEUTICALS, INC.
As filed with the Securities and Exchange Commission on
July 25, 2006
Registration No.
333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
CATALYST PHARMACEUTICAL PARTNERS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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2834 |
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Applied For |
(State or other jurisdiction of
incorporation or organization) |
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(Primary Standard Industrial
Classification Code Number) |
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(I.R.S. Employer
Identification Number) |
220 Miracle Mile
Suite 234
Coral Gables, Florida 33134
(305) 529-2522
(Name, address, including zip code, and telephone number,
including area code, of registrants principal executive
offices)
Patrick J. McEnany
Chief Executive Officer
Catalyst Pharmaceutical Partners, Inc.
220 Miracle Mile
Suite 234
Coral Gables, Florida 33134
(305) 529-2522
(Name, address, including zip code, and telephone number,
including area code,
of agent for service)
Copies To:
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Philip B. Schwartz, Esq.
Akerman Senterfitt
One Southeast Third Avenue
Miami, Florida 33131
(305) 374-5600 |
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Donald J. Murray, Esq.
Dewey Ballantine LLP
1301 Avenue of the Americas
New York, New York 10019-6092
(212) 259-8000 |
Approximate date of commencement of proposed sale to
public: As soon as practicable after this registration
becomes effective
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to
Rule 415 under the Securities Act, check the following
box: o
If this Form is used to register additional securities for an
offering pursuant to Rule 462(b) under the Securities Act,
check the following box and list the Securities Act registration
number of the earlier effective registration statement for the
same
offering: o
If this Form is a post-effective amendment filed pursuant to
Rule 462(c) under the Securities Act, check the following
box and list the Securities Act registration statement number of
the earlier effective registration statement for the same
offering: o
If this Form is a post-effective amendment filed pursuant to
Rule 462(d) under the Securities Act, check the following
box and list the Securities Act registration number of the
earlier effective registration statement for the same
offering: o
CALCULATION OF REGISTRATION FEE
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Proposed maximum |
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Title of each class of |
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aggregate offering |
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Amount of |
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securities to be registered |
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price (1) |
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registration fee |
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Common Stock, par value $0.001 per share
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$40,250,000 |
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$4,306.75 |
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(1) |
Estimated solely for the purpose of calculating the amount of
the registration fee pursuant to Rule 457(o) under the
Securities Act of 1933, as amended. |
The registrant hereby amends this registration statement on
such date or dates as may be necessary to delay its effective
date until the registrant shall file a further amendment which
specifically states that this registration statement shall
become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the registration statement shall
become effective on such date as the Commission, acting pursuant
to Section 8(a), may determine.
The information
in this preliminary prospectus is not complete and may be
changed. We may not sell these securities until the registration
statement filed with the Securities and Exchange Commission is
effective. This preliminary prospectus is not an offer to sell
these securities and is not soliciting an offer to buy these
securities in any state where the offer or sale is not
permitted.
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SUBJECT TO COMPLETION, DATED
JULY 25, 2006
Common Stock
Shares
This is the initial public offering of our common stock and no
public market currently exists for our shares. We expect that
the public offering price will be between
$ and
$ per
share.
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The Offering |
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Per Share |
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Total |
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Public Offering Price
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$ |
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Underwriting Discounts and Commissions
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$ |
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$ |
Proceeds, Before Expenses, to Catalyst
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$ |
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$ |
We have applied to have our common stock included for quotation
on the Nasdaq Global Market under the symbol CPRX.
Investing in our common stock involves a high degree of
risk.
See Risk Factors beginning on page 7.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
We have granted the underwriters the right to purchase up
to additional
shares from us within 30 days after the date of this
prospectus to cover over-allotments, if any. The underwriters
expect to deliver shares of common stock to purchasers on or
about ,
2006.
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First Albany Capital |
Stifel Nicolaus |
The date of this prospectus
is ,
2006
You should rely only on the information contained in this
prospectus. We have not, and the underwriters have not,
authorized anyone to provide you with different information. If
anyone provides you with different or inconsistent information,
you should not rely on it. We are not, and the underwriters are
not, making an offer to sell these securities in any
jurisdiction where the offer and sale is not permitted. You
should assume that the information in this prospectus is
accurate as of the date on the front cover of this prospectus
only. Our business, financial condition, results of operations
and prospects may have changed since that date.
Sabril is a registered trademark of Sanofi-Aventis.
TABLE OF CONTENTS
2
PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the
more detailed information appearing elsewhere in this
prospectus. Individuals who participate in this offering are
urged to read this prospectus in its entirety. An investment in
the shares offered hereby involves a high degree of risk. This
prospectus contains forward-looking statements that involve
risks and uncertainties. Our actual results may differ
significantly from the projected results discussed in these
forward-looking statements. Factors that may cause such a
difference include, but are not limited to, those discussed in
Risk Factors. We, our,
ours, us, or the company
when used herein, refers to Catalyst Pharmaceutical Partners,
Inc.
We are a specialty pharmaceutical company focused on the
development and commercialization of prescription drugs for the
treatment of addiction. Our initial product candidate is
CPP-109, which is based on the chemical compound
gamma-vinyl-GABA, commonly referred to as vigabatrin. We
intend to begin in the fourth quarter of 2006 a U.S. Phase II
clinical trial evaluating CPP-109 for the treatment of cocaine
addiction. We also intend to develop CPP-109 to treat
methamphetamine addiction. We believe that our CPP-109 platform
has the potential to produce therapies for other addictions,
including addictions to nicotine, prescription pain medications,
alcohol, and marijuana, as well as treatments for related
addictive disorders, such as obesity and compulsive gambling.
Drug abuse and addiction, including cocaine and methamphetamine
abuse, comprise a worldwide health problem that affects millions
of people and has wide-ranging negative social consequences.
According to the Office of National Drug Control Policy, costs
of drug abuse to society were an estimated $180 billion in
2002 in the United States. In 2004, an estimated 19 million
people in the United States suffered from dependence on illicit
drugs, according to the National Survey on Drug Use and Health,
published by the Substance Abuse and Mental Health Services
Administration, or SAMHSA. According to the same source,
approximately two million people used cocaine in the month
preceding the survey, approximately one million were new users
in 2004, and approximately 884,000 patients sought treatment for
cocaine abuse in 2004. Also according to the SAMHSA survey,
approximately 583,000 people used methamphetamine in the month
preceding the survey, approximately 318,000 were new users in
2004, and approximately 393,000 patients sought treatment for
methamphetamine abuse in 2004. According to the United Nations
Office for Drug Control and Crime Prevention, in 2004 there were
approximately 3.4 million users of cocaine and
2.7 million users of amphetamine-type stimulants across
Europe. Despite the significance of cocaine and methamphetamine
abuse as a worldwide public health problem, there are no
currently approved pharmaceutical therapies for cocaine and
methamphetamine abuse.
Many addictive drugs, including cocaine and methamphetamine,
produce feelings of euphoria by increasing the concentration of
the chemical neurotransmitter dopamine in specific areas of the
brain. Under normal conditions, dopamine levels are relatively
constant, increasing temporarily as a result of experiences such
as eating or sexual arousal. Over time, the feeling of pleasure
is decreased by a reduction in dopamine to its pre-arousal level
and through the action of gamma-aminobutyric acid, or
GABA, a chemical neurotransmitter that inhibits the effect of
dopamine. Substances such as cocaine and methamphetamine cause
enormous amounts of dopamine buildup, producing feelings of
euphoria. CPP-109 increases the amount of GABA present, which
suppresses the responses to the dramatic increase in dopamine
levels produced by cocaine and methamphetamine, thereby
preventing the perception of pleasure that is associated with
their use.
We have been granted an exclusive worldwide license from
Brookhaven National Laboratory to nine U.S. patents and two U.S.
patent applications relating to the use of vigabatrin for the
treatment of a wide variety of substance addictions. The nine
issued patents expire between 2018 and 2020. Additionally, we
have received approval from the European Union with respect to
one of our principal patents, which will allow us to seek
approval for this patent in each of the EU member states.
In the fourth quarter of 2006, we plan to begin an approximately
375 patient, double-blind, randomized, placebo-controlled Phase
II clinical trial in the United States to evaluate CPP-109 for
the treatment of cocaine
3
addiction. This trial is designed to provide potentially pivotal
efficacy data, which may support the filing of a New Drug
Application, or NDA, although we cannot assure you as to whether
additional non-clinical or clinical trials may be required
before we are permitted to file an NDA for CPP-109. We are also
supporting a 100 patient, double-blind, placebo-controlled
clinical trial in Mexico evaluating CPP-109 for treatment of
cocaine addiction. Further, we are supporting an ongoing
10-patient, double-blind, placebo-controlled clinical study
evaluating CPP-109 for the reduction of cocaine cravings. In
addition, two open-label pilot studies were conducted in Mexico
in 2003 and 2004 by a member of our Scientific Advisory Board.
In one study, of the 30 patients enrolled, 18 completed the
study and 16 of these tested negative for methamphetamine and
cocaine during the last six weeks of the trial. In another
study, of the 20 patients enrolled, eight completed the study
and remained drug-free for periods ranging from
46-58 days. During and
for at least six weeks following the completion of these trials,
many of the completers reported reduced cravings, beneficial
weight gain and other positive behavioral changes. These studies
strongly support our intention to advance
CPP-109 as a potential
treatment for cocaine and methamphetamine addiction.
In December 2004, the Food and Drug Administration, or FDA,
accepted our Investigational New Drug application, or IND, for
CPP-109 for the treatment of cocaine addiction. We have been
granted Fast Track status by the FDA for CPP-109, a
designation intended to facilitate drug development and expedite
the regulatory review process. A treatment for cocaine addiction
is recognized as addressing an unmet medical need for which no
pharmacological products are currently approved for marketing.
As a result, we believe that the receipt of Fast Track status
may accelerate the regulatory approval process, although we
cannot assure you that our clinical trials will be successful or
that we will obtain approval of an NDA for CPP-109.
We were incorporated in July 2006. Our predecessor, Catalyst
Pharmaceutical Partners, Inc., a Florida corporation, was
incorporated in the State of Florida in January 2002. Prior to
the completion of this offering, we will succeed, by merger, to
all of the assets, liabilities, rights and operations of our
predecessor. Our principal executive offices are located at 220
Miracle Mile, Suite 234, Coral Gables, Florida 33134, our
telephone number is (305) 529-2522 and our website is
www.catalystpharma.com. The information contained on our website
is not part of this prospectus. Subject to the approval of our
stockholders, we intend to reincorporate in Delaware in the near
future.
Our Business Strategy
To facilitate our business development and growth, we plan to:
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Focus on CPP-109 for cocaine addiction. We intend to
commence a Phase II clinical trial for the use of CPP-109 for
treating cocaine addiction. Treatment for cocaine addiction
addresses a significant unmet medical need, and we believe that
our receipt of Fast Track status may facilitate the regulatory
approval process. |
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Develop additional indications for CPP-109. The mechanism
of action of CPP-109 makes it suitable as a potential treatment
for addiction states that share the common element of heightened
dopamine levels. We plan next to develop CPP-109 for the
treatment of methamphetamine addiction. Further, our research
indicates that CPP-109 is a platform technology with the
potential to treat other conditions involving heightened
dopamine levels such as addictions to nicotine, prescription
pain medications, alcohol, marijuana, and related addictive
disorders, including obesity and compulsive gambling. |
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Acquire or license additional addiction therapies. We
know of other product candidates that may have potential for the
treatment of addiction. We may seek to acquire or license one or
more of these product candidates to expand our development
programs. We have entered into no such agreements to date. |
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Develop second generation of CPP-109. We plan to develop
a new formulation of CPP-109. If we are successful, we intend to
initially seek approval for this new formulation in Europe,
where we may be |
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able to obtain exclusive marketing rights. Subsequently, we may
seek approval for this new formulation in the United States. |
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Leverage the services of thought leaders in addiction
treatment. We believe that members of our Scientific
Advisory Board are among the most respected researchers in the
field of addiction therapy. We intend to utilize their
knowledge, services and relationships to guide our development
process and commercialization strategy. |
Risks Affecting Our Business
Our business is subject to numerous risks, as more fully
described in the section entitled Risk Factors
immediately following this Prospectus Summary. We have a limited
operating history and have not yet commercialized any products.
We have no sources of revenue, and we have incurred operating
losses of approximately $3.7 million from inception through
June 30, 2006. We expect to incur operating losses for the
foreseeable future. Our product candidate is at an early stage
of development, and failure can occur at any stage of
development. Our product candidate, CPP-109, has not received
regulatory approval for commercialization, and drugs resulting
from our product development efforts may not be commercially
available for a number of years, if at all. We may never
generate any product revenues or achieve profitability.
5
The Offering
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Common stock offered: |
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shares |
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Common stock outstanding after this offering: |
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Use of proceeds: |
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We plan to use the net proceeds from this offering to fund our
planned U.S. Phase II clinical trial of CPP-109 for use in
treating cocaine addiction; to conduct, if required, a U.S.
Phase III clinical trial of CPP-109 for use in treating cocaine
addiction to submit and seek approval of an NDA for CPP-109 for
use in treating cocaine addiction and to pay for any required
non-clinical testing of CPP-109; to begin additional clinical
studies and trials for the use of CPP-109 in treating
methamphetamine and nicotine addiction; to begin development of
clinical studies and trials needed to commercialize CPP-109 in
Europe and for general corporate purposes. In addition, we may
use a portion of the net proceeds to license or acquire one or
more products that show promise in the treatment of addiction.
No agreements with respect to any acquisition have been entered
into to this date. |
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Proposed Nasdaq Global Market symbol: |
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CPRX |
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Risk factors: |
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You should read the Risk Factors section of this
prospectus for a discussion of factors to consider before
deciding whether to invest in our common stock. |
The number of shares of our common stock outstanding after this
offering is based on the 6,281,900 shares outstanding as of
the date of this prospectus, and excludes as of that date:
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1,500,000 shares of common stock reserved for future grants
under our 2006 Stock Incentive Plan; |
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1,603,000 shares of common stock reserved for issuance upon the
exercise of outstanding stock options having a weighted exercise
price of $1.67 per share. |
Unless otherwise stated, all information in this prospectus
assumes:
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no exercise of the underwriters over-allotment option; and |
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the automatic conversion of all of our outstanding preferred
stock into 1,464,400 shares of our common stock immediately upon
the completion of this offering. |
6
Summary Financial Data
The following table sets forth our summary financial data for
the three years ended December 31, 2005, which have been
derived from our audited financial statements included elsewhere
in this prospectus. In addition, the table includes summary
financial data for the six months ended June 30, 2006 and
2005, and as of June 30, 2006, which have been derived from
our unaudited financial statements included elsewhere in this
prospectus. Our unaudited financial statements have been
prepared on a basis substantially consistent with our audited
financial statements and, in the opinion of management, include
all adjustments (consisting of normally recurring adjustments)
necessary for a fair presentation of results under those
periods. It is important that you read this information together
with Managements Discussion and Analysis of
Financial Condition and Results of Operations, Risk
Factors and our financial statements and the related notes
and schedules to these financial statements beginning on Page
F-1 of this prospectus. Our interim financial results are not
necessarily indicative of our financial results for the full
year, and our historical results presented below are not
necessarily indicative of results to be expected in future
periods.
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Cumulative period | |
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from January 4, | |
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Six Months Ended June 30, | |
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Year Ended December 31, | |
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2002 (date of | |
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inception) through | |
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2006 | |
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2005 | |
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2005 | |
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2004 | |
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2003 | |
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June 30, 2006 | |
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(unaudited) | |
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(unaudited) | |
Statement of Operations Data:
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Revenues
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$ |
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$ |
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$ |
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$ |
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$ |
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$ |
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Operating costs and expenses:
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Research and development
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191,639 |
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187,394 |
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290,139 |
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83,421 |
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172,996 |
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800,042 |
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General and administrative
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242,194 |
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126,811 |
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359,279 |
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164,704 |
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165,483 |
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1,049,925 |
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Non-cash compensation
(3)
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241,125 |
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1,013,375 |
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1,172,750 |
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294,833 |
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95,833 |
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1,880,374 |
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Total operating expenses
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674,958 |
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1,327,580 |
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1,822,168 |
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542,958 |
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434,312 |
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3,730,341 |
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Loss from operations
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(674,958 |
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(1,327,580 |
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(1,822,168 |
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(542,958 |
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(434,312 |
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(3,730,341 |
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Interest income
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8,133 |
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5,908 |
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16,788 |
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3,138 |
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5,697 |
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33,756 |
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Loss before income taxes
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(666,825 |
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(1,321,672 |
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(1,805,380 |
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(539,820 |
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(428,615 |
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(3,696,585 |
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Provision for income taxes
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Net loss
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$ |
(666,825 |
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$ |
(1,321,672 |
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$ |
(1,805,380 |
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$ |
(539,820 |
) |
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$ |
(428,615 |
) |
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$ |
(3,696,585 |
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Basic and diluted net loss per share
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$ |
(0.14 |
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$ |
(0.35 |
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$ |
(0.42 |
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$ |
(0.27 |
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$ |
(0.21 |
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Weighted average shares outstanding basic and diluted
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4,720,000 |
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3,767,033 |
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4,252,219 |
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2,000,000 |
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2,000,000 |
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June 30, 2006 | |
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Actual | |
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Pro forma(1) | |
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Pro forma as adjusted(2) | |
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Balance Sheet Data:
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Cash and cash equivalents
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$ |
324,154 |
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$ |
3,549,294 |
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$ |
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Working capital (deficiency)
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(107,516 |
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3,117,624 |
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Total assets
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365,113 |
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3,590,253 |
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Total liabilities
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434,351 |
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434,351 |
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Stockholders equity (deficit)
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(69,238 |
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3,350,902 |
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(1) |
Pro forma gives effect to our completion of a private placement
on July 24, 2006 of 7,644 shares of our Series B Preferred Stock
from which we received net proceeds of $3,225,140, the automatic
conversion of these |
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Series B preferred shares upon the closing of this offering
into 764,400 shares of our common stock, and the issuance of
97,500 shares of our common stock in July 2006 relating to
services performed for us by certain of our consultants and
scientific advisors during 2004, 2005 and the first six months
of 2006. |
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(2) |
Pro forma information as adjusted gives further effect to our
sale of shares of
common stock in this offering at an assumed initial public
offering price of
$ per
share and our receipt of an estimated
$ in
net proceeds therefrom, after deducting underwriting discounts
and commissions and estimated offering expenses to be paid by us. |
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(3) |
Represents additional research and development expenses. |
8
RISK FACTORS
Any investment in our securities involves a high degree of
risk. You should carefully consider the risks and uncertainties
described below, and all information contained in this
prospectus, before you decide whether to purchase our
securities. Additional risks and uncertainties not currently
known to us or that we currently do not deem material may also
become important factors that may materially and adversely
affect our business. The occurrence of any of the following
risks could cause our business, results of operations, financial
condition and prospects to materially suffer and the market
price of our stock to decline, and you may lose part or all of
your investment.
Risks Related to Our Business
We are a development stage company whose limited operating
history makes it difficult to evaluate our future
performance.
We are a development stage company that began operations in
2002. As such, we have a limited operating history upon which
you can evaluate our current business and our prospects. The
likelihood of our future success must be viewed in light of the
problems, expenses, difficulties, delays and complications often
encountered in the operation of a new business, especially in
the pharmaceutical industry, where failures of new companies are
common. We are subject to the risks inherent in the ownership
and operation of a development stage company, including
regulatory setbacks and delays, fluctuations in expenses,
competition and government regulation. If we fail to address
these risks and uncertainties our business, results of
operations, financial condition and prospects would be adversely
affected.
We have had no revenues from operations to date and we expect to
incur losses at least until we can commercialize CPP-109. Our
net loss was $1,805,380 for the year ended December 31,
2005 and $666,825 for the six months ended June 30, 2006,
and as of June 30, 2006 we had an accumulated deficit of
$3,696,585. We may not obtain approval of an NDA for CPP-109.
Even if we are successful in obtaining such approval, we may not
be able to commercialize CPP-109 successfully. Further, if we
are successful in obtaining approval to commercialize CPP-109,
we will need to significantly expand our operations, which could
put significant strain on our management and our operational and
financial resources. We currently have only four employees and
conduct most of our operations through outsourcing arrangements.
To manage future growth, we will need to hire, train, and manage
additional employees, particularly a specially-trained sales
force to market our products. Concurrent with expanding our
operational and marketing capabilities, we will also need to
increase our product development activities. We may not be able
to support future growth, or hire, train, motivate, and manage
the required personnel. Our failure to manage growth effectively
could limit our ability to achieve our goals.
We are subject to product development risks.
There is currently little scientific evidence indicating that
CPP-109 will be a safe and effective treatment for any addiction
in humans. Our studies and clinical trials evaluating CPP-109
may fail, and we may never commercialize this product candidate.
We will also have to conduct non-clinical testing on CPP-109 in
order to be in a position to file an NDA, although the scope of
such required testing is uncertain, and we are currently unable
to determine the timing of such non-clinical testing. To date,
we have sponsored two
open-label clinical
studies relating to the use of vigabatrin in the treatment of
cocaine and methamphetamine addiction. Only 26 persons in the
aggregate completed these trials. Additionally, some of the
study results described in this prospectus, such as evidence
regarding beneficial weight gain, employment or other behavioral
changes, have little scientific correlation to the safety or
efficacy of CPP-109 as a treatment for addiction, and therefore
are not reliable as evidence of safety or efficacy. The results
of these studies are not necessarily predictive of results that
will be obtained in later stages of clinical testing or ensure
success in later stage clinical trials.
Development of our pharmaceutical product candidates is subject
to risks of failure. For example:
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CPP-109 may be found to be ineffective or unsafe, or fail to
receive necessary regulatory approvals; |
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CPP-109, even if found to be safe and effective, could prove
difficult or impossible to manufacture on a large scale or on a
cost-effective basis; |
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CPP-109 may be uneconomical to market or take substantially
longer to obtain necessary regulatory approvals than
anticipated; or |
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competitors may market equivalent or superior products. |
As a result, our product development activities may not result
in any safe, effective and commercially viable products, and we
may not be able to commercialize our products successfully. Our
failure to develop safe, effective, and commercially viable
products would have a material adverse effect on our business,
prospects, results of operations and financial condition.
We will only obtain regulatory approval to commercialize CPP-109
if we can demonstrate to the satisfaction of the FDA (or the
equivalent foreign regulatory authorities) in adequate and
well-controlled clinical studies that the drug is safe and
effective for its intended use and that it otherwise meets
approval requirements. A failure of one or more preclinical or
clinical studies can occur at any stage of product development.
We may experience numerous unforeseen events during, or as a
result of, testing that could delay or prevent us from obtaining
regulatory approval for or commercializing CPP-109, including:
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regulators or institutional review boards, which are commonly
called IRBs, may not authorize us to commence a clinical trial
or conduct a clinical trial at a prospective trial site; |
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conditions may be imposed upon us by the FDA regarding the scope
or design of our clinical trials, or we may be required to
resubmit our clinical trial protocols to IRBs for reinspection
due to changes in the regulatory environment; |
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we may be unable to reach agreements on acceptable terms with
prospective clinical research organizations; |
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the number of subjects required for our clinical trials may be
larger than we anticipate, patient enrollment may take longer
than we anticipate, or patients may drop out of our clinical
trials at a higher rate than we anticipate; |
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we may have to suspend or terminate one or more of our clinical
trials if we, regulators, or IRBs determine that the
participants are being subjected to unreasonable health risks; |
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our third-party contractors or clinical investigators may fail
to comply with regulatory requirements or fail to meet their
contractual obligations to us in a timely manner; |
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our tests may produce negative or inconclusive results, and we
may decide, or regulators may require us, to conduct additional
testing; and |
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the costs of our clinical trials may be greater than we
anticipate. |
We are dependent on a single chemical compound,
vigabatrin.
To date, we have invested, and will in the foreseeable future
continue to invest, most or all of our time and resources to
develop products using a single chemical compound, vigabatrin,
for the treatment of addictions. Because all of our potential
products are based on this chemical compound, if we cannot
successfully develop and market products using it, and if we are
not successful in commercializing such products, it would have
an adverse effect on our business, financial condition, results
of operations and prospects.
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Vigabatrin, the single chemical compound on which we depend,
has known side effects that may hinder our ability to produce
safe and commercially viable products.
When used long-term as a treatment for epilepsy, a formulation
of vigabatrin marketed as Sabril has been found to cause the
development of peripheral visual field defects, known as VFDs,
that increase progressively with continuing drug treatment. We
intend to include a standardized evaluation of each
patients visual fields before, during and after completion
of our clinical studies and trials. We do not yet know whether
our ultimate formulation for and dosing of vigabatrin will cause
VFDs or how the potential for this known side effect will affect
our ability to obtain marketing approval for CPP-109.
In addition to VFDs, a wide variety of other adverse effects,
including depression and other psychiatric reactions, have been
noted in patients treated with Sabril. As patients with seizures
often require treatment with multiple drugs, the relationship of
such adverse effects to Sabril, including the VFDs described
above, has not always been clear; however, such side effects
tended to disappear when treatment with Sabril was stopped.
These known side effects, as well as other side effects that may
be discovered during our clinical trials and studies, may cause
the FDA or other governmental agencies to halt clinical studies
prior to their completion, prevent the initiation of further
clinical studies, or deny the approval of CPP-109 as a treatment
for addiction. These known side effects may also cause the FDA
to impose marketing restrictions on CPP-109. For example, the
FDA may require specialized training for, or otherwise limit the
ability of, physicians to prescribe CPP-109 and of pharmacists
to fill prescriptions for CPP-109, may restrict our ability to
advertise CPP-109, and may require us to keep a registry of
patients who are prescribed CPP-109 to prevent such patients
from using CPP-109 over an extended period of time.
We rely on third parties to conduct our clinical trials, and
if they do not perform their obligations to us, we may not be
able to obtain approval for CPP-109.
We do not have the ability to conduct our clinical trials
independently. We rely on academic institutions, corporate
partners such as Brookhaven, and other third parties to assist
us in designing, managing, monitoring and otherwise carrying out
our clinical trials. Accordingly, we do not have control over
the timing or other aspects of these clinical trials. If these
third parties do not successfully carry out their duties, both
our clinical trials and our business may be materially adversely
affected.
Although we rely on third parties to manage the data from these
clinical trials, we are responsible for confirming that each
clinical trial is conducted in accordance with its general
investigational plan and protocol. Moreover, FDA and foreign
regulatory agencies require us to comply with regulations and
standards, commonly referred to as good clinical practice, for
conducting, recording and reporting the results of clinical
trials to assure that the data and the results are credible and
accurate and that the trial participants are adequately
protected. Our reliance on third parties does not relieve us of
these obligations and requirements, and we may fail to obtain
regulatory approval for CPP-109 if these requirements are not
met.
If we are unable to file for approval for additional
indications for CPP-109 through supplemental NDAs, or if we are
required to generate additional data related to safety and
efficacy in order to obtain such approval for additional
indications, we may suffer material harm to our future financial
performance.
Our current plans for development of CPP-109 include efforts to
minimize the data we will need to generate in order to obtain
marketing approval of CPP-109 for methamphetamine addiction and
other additional indications. If we are successful in obtaining
approval of an NDA for CPP-109 as a treatment for cocaine
addiction, of which there can be no assurance, in the future we
plan to submit supplemental NDAs for additional indications.
Depending on the data we rely upon, approval for additional
indications for CPP-109 may be delayed. In addition, even if we
receive supplemental NDA approval, the FDA has broad discretion
to require us to generate additional data related to safety and
efficacy to supplement the data used in the supplemental NDA
filing. We could be required, before obtaining marketing
approval for CPP-109 for additional indications, to
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conduct substantial new research and development activities,
which could be more costly and time-consuming than we currently
anticipate. We may not be able to obtain shortened review of our
applications, and the FDA may not agree that we can market
CPP-109 for additional indications. If we are required to
generate substantial additional data to support approval, our
product development and commercialization efforts will be
delayed and we may suffer significant harm to our future
financial performance.
We will need to develop marketing, distribution and
production capabilities or relationships to be successful.
We do not currently have any marketing, distribution or
production capabilities. In order to generate sales of CPP-109
or any other products we may develop, we must either acquire or
develop an internal marketing force with technical expertise and
with supporting documentation capabilities, or make arrangements
with third parties to perform these services for us. The
acquisition and development of a marketing and distribution
infrastructure will require substantial resources and compete
for available resources with our product development efforts. To
the extent that we enter into marketing and distribution
arrangements with third parties, our revenues will depend on the
efforts of others. If we fail to enter into such agreements, or
if we fail to develop our own marketing and distribution
channels, we would experience delays in product sales and incur
increased costs.
Similarly, we have no manufacturing capacity for production of
our products. We have entered into an agreement with a contract
manufacturer for the manufacture of CPP-109 for use in our U.S.
Phase II trial and to manufacture CPP-109 for us if we are
successful in obtaining FDA approval to commercialize this
product. We also have a contract to acquire the active
pharmaceutical ingredient used in CPP-109. Any third party we
contract with may not meet our manufacturing requirements, and
may not pass FDA inspection. Moreover, if any third party fails
to perform on a timely basis we may not be able to find a
suitable replacement. If we cannot obtain sufficient amounts of
CPP-109 or any related final product, it would have a material
adverse effect on our ability to successfully market CPP-109.
Our business is subject to substantial competition.
The development and commercialization of new drugs is highly
competitive worldwide. Although there is no currently approved
prescription drug treatment for cocaine or methamphetamine
addiction, there are a significant number of other companies
that are pursuing the development of drugs that, if approved and
commercialized, would be competitive with CPP-109. Some of these
other drugs have already begun or even completed Phase II
clinical trials. In addition, some or all of these drugs may not
have the side effects currently associated with vigabatrin,
including VFDs. Therefore, these competitive drugs may be
approved by the FDA instead of, or more quickly than, CPP-109,
and if approved may be more acceptable to health care providers.
Further, we expect that the number of companies seeking to
develop prescription drugs to treat drug addiction will
increase. Other products may be developed that either render
CPP-109 obsolete or have advantages that significantly outweigh
those of CPP-109.
Many of our competitors have substantially greater financial,
technical, and human resources than we do. In addition, many of
our competitors have significantly greater experience than we do
in conducting clinical studies and obtaining regulatory
approvals of prescription drugs. Accordingly, our competitors
may succeed in obtaining FDA approval for products more rapidly
than we can. Furthermore, if we are permitted to commence
commercial sales of CPP-109, we may also compete with respect to
manufacturing efficiency and marketing capabilities. For all of
these reasons, we may not be able to compete successfully.
We may encounter difficulties in managing our growth, which
would adversely affect our results of operations.
In connection with a future commercial launch of CPP-109, we may
experience rapid and significant growth in the number of our
employees and the scope of our operations. This growth and
expansion is expected
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to place a significant demand on our financial, managerial and
operational resources. Our competitive position in the
marketplace, our future financial performance and our success in
commercializing CPP-109 and any other products will depend
largely on our ability to manage any future growth effectively.
Our success in managing our growth will depend in part on the
ability of our executive officers to continue to implement and
improve our operational, management, information and financial
control systems and to expand, train and manage our employee
base. We may not be able to attract and retain personnel on
acceptable terms given the intense competition for such
personnel among biotechnology, pharmaceutical and healthcare
companies, universities and non-profit research institutions.
Our inability to manage growth effectively could cause our
operating costs to grow at a faster pace than we currently
anticipate, and could have a material adverse effect on our
business, financial condition and results of operations.
We face a risk of product liability claims and may not be
able to obtain adequate insurance.
Our business exposes us to potential liability risks that may
arise from the clinical testing, manufacture, and sale of
CPP-109. Patients have received substantial damage awards in
some jurisdictions against pharmaceutical companies based on
claims for injuries allegedly caused by the use of
pharmaceutical products. Liability claims may be expensive to
defend and result in large judgments against us. While we intend
to carry liability insurance during our clinical trials with an
aggregate annual coverage limit of $10,000,000, with a
deductible of $50,000 per occurrence and $500,000 in the
aggregate, we do not currently have such a policy. We may not be
able to obtain a policy for these amounts at a reasonable cost,
or at all. Even if we obtain sufficient liability coverage, our
insurance may not reimburse us, or this coverage may not be
sufficient to cover claims made against us. We cannot predict
all of the possible harms or side effects that may result from
the use of CPP-109 or any of our other future products and,
therefore, the amount of insurance coverage we may be able to
obtain may not be adequate to cover all liabilities we might
incur. If we are sued for any injury allegedly caused by our
products, our liability could exceed our ability to pay the
liability. Whether or not we are ultimately successful in any
adverse litigation, such litigation could consume substantial
amounts of our financial and managerial resources, all of which
could have a material adverse effect on our business, financial
condition, results of operations, prospects and stock price.
Our commercial success depends on reimbursement from
third-party and governmental insurers.
Sales of pharmaceutical products in the United States depend
largely on reimbursement of patients costs by private
insurers, government health care programs including Medicare and
Medicaid, and other organizations. These third-party payors
control healthcare costs by limiting both coverage and the level
of reimbursement for healthcare products. The rising costs of
pharmaceutical products, in particular, has recently been the
subject of considerable attention and debate. Third-party payors
are increasingly altering reimbursement levels and challenging
the price and cost-effectiveness of pharmaceutical products. The
reimbursement status of newly approved pharmaceutical products
in particular is generally uncertain. The levels at which
government authorities and private health insurers reimburse
physicians or patients for the price they pay for CPP-109 and
other products we may develop could affect the extent to which
we are able to commercialize our products successfully.
We have no experience as a public company, and the
obligations incident to being a public company will place
significant demands on our management.
Since our inception, we have operated as a private company, not
subject to the requirements applicable to public companies.
While we plan to expand our finance and accounting staff when we
become public, and currently we have only a very small
accounting department, we may encounter substantial difficulty
attracting qualified staff with requisite experience due to the
high level of competition for experienced financial
professionals.
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As a public reporting company, we will need to comply with the
Sarbanes-Oxley Act of 2002 and the related rules and regulations
of the SEC, including periodic reports, disclosures and more
complex accounting rules. As directed by Section 404 of
Sarbanes-Oxley, the SEC adopted rules requiring public companies
to include a report of management on a companys internal
control over financial reporting in their Annual Report on
Form 10-K. In addition, the independent registered public
accounting firm auditing our financial statements must attest to
and report on managements assessment of the effectiveness
of our internal control over financial reporting. If we close
this offering as planned during 2006, this requirement will
first apply to our Annual Report on Form 10-K for the
fiscal year ending December 31, 2007. If we are unable to
conclude that we have effective internal control over our
financial reporting at December 31, 2007, and future
year-ends as required by Section 404 of Sarbanes-Oxley,
investors could lose confidence in the reliability of our
financial statements, which could result in a decrease in the
value of our common stock.
Risks Related to Our Intellectual Property
We are dependent on our relationship and license agreement
with Brookhaven, and we rely upon the patents granted to us
pursuant to the license agreement.
All of our patent rights are derived from our license agreement
with Brookhaven Science Associates, as operator of Brookhaven
National Laboratory under contract with the United States
Department of Energy, or Brookhaven. Pursuant to this license
agreement, we have licensed rights under nine patents and two
patent applications in the United States, and 79 corresponding
patents and patent applications outside of the United States,
that were filed and obtained by Brookhaven relating to the use
of vigabatrin to treat addiction. We also have the right to
future patents obtained by Brookhaven relating to the use of
vigabatrin in treating addiction. These rights are subject to
the right of the U.S. government, under limited circumstances,
to practice the covered inventions for or on its own behalf. We
may lose our rights to these patents and patent applications if
we breach our obligations under the license agreement,
including, without limitation, our financial obligations to
Brookhaven. If we violate or fail to perform any term or
covenant of the license agreement, Brookhaven may terminate the
license agreement upon satisfaction of any applicable notice
requirements and expiration of any applicable cure periods.
Additionally, any termination of the license agreement, whether
by us or by Brookhaven, will not relieve us of our obligation to
pay any license fees owing at the time of such termination. If
we fail to retain our rights under the license agreement, we
would not be able to commercialize CPP-109, and our business,
results of operations, financial condition and prospects would
be materially adversely affected.
The license agreement also grants us rights to two pending U.S.
patent applications. These applications may not result in issued
patents. If patents are issued, any such patents might not
provide any commercial benefit to us. In addition, our academic
collaborators may have certain rights to publish data and
information in which we have rights, and if they do so our
proprietary position in this data and information could be
impaired or lost altogether.
If we obtain approval to market CPP-109, our commercial success
will depend in large part on our ability to use patents,
especially those licensed to us by Brookhaven, to exclude others
from competing with us. The patent position of emerging
pharmaceutical companies like us can be highly uncertain and
involve complex legal and technical issues. Until our licensed
patents are interpreted by a court, either because we have
sought to enforce them against a competitor or because a
competitor has preemptively challenged them, we will not know
the breadth of protection that they will afford us. Our patents
may not contain claims sufficiently broad to prevent others from
practicing our technologies or marketing competing products.
Third parties may intentionally design around our patents so as
to compete with us without infringing our patents. Moreover, the
issuance of a patent is not conclusive as to its validity or
enforceability, and so our patents may be invalidated or
rendered unenforceable if challenged by others.
As a result of the foregoing factors, we cannot be certain how
much protection from competition patent rights will provide us.
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Our success will depend significantly on our ability to
operate without infringing the patents and other proprietary
rights of third parties.
There may be third-party patents whose claims we infringe. In
the event that our technologies infringe or violate the patent
or other proprietary rights of third parties, we may be
prevented from pursuing product development, manufacturing or
commercialization of our products that utilize such
technologies. There may be patents held by others of which we
are unaware that contain claims that our products or operations
infringe. In addition, given the complexities and uncertainties
of patent laws, there may be patents of which we are aware that
we may ultimately be held to infringe, particularly if the
claims of the patent are determined to be broader than we
believe them to be. Adding to this uncertainty, in the United
States, patent applications filed in recent years are
confidential for 18 months, while older applications are
not publicly available until the patent issues. As a result,
avoiding patent infringement may be difficult.
If a third party claims that we infringe its patents, any of the
following may occur:
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we may be required to pay substantial financial damages if a
court decides that our technologies infringe a competitors
patent, which can be tripled if the infringement is deemed
willful, or be required to discontinue or significantly delay
development, marketing, selling and licensing of the affected
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a court may prohibit us from selling or licensing our product
without a license from the patent holder, which may not be
available on commercially acceptable terms or at all, or which
may require us to pay substantial royalties or grant
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we may have to redesign our product so that it does not infringe
others patent rights, which may not be possible or could
require substantial funds or time. |
In addition, employees, consultants, contractors and others may
use the proprietary information of others in their work for us
or disclose our proprietary information to others. Either of
these events could lead to disputes over the ownership of
inventions derived from that information or expose us to
potential damages or other penalties.
The occurrence of any of these events could have a material
adverse effect on our business, financial condition, results of
operations or prospects.
We may incur substantial costs as a result of litigation or
other proceedings relating to patent and other intellectual
property rights.
There is a history of substantial litigation and other
proceedings regarding patent and intellectual property rights in
the pharmaceutical industry. We may be forced to defend claims
of infringement brought by our competitors and others, and we
may institute litigation against others who we believe are
infringing our intellectual property rights. The outcome of
intellectual property litigation is subject to substantial
uncertainties and may, for example, turn on the interpretation
of claim language by the court, which may not be to our
advantage, or on the testimony of experts as to technical facts
upon which experts may reasonably disagree.
Our involvement in intellectual property litigation could result
in significant expense to us. Some of our competitors have
considerable resources available to them and a strong economic
incentive to undertake substantial efforts to stop or delay us
from commercializing products. For example, Ovation
Pharmaceuticals, Inc., or Ovation, which holds rights in North
America to Sabril for the treatment of epilepsy, has indicated
its intent to seek to develop Sabril for the treatment of
cocaine addiction. We believe that Ovation would infringe our
patent rights, and we would pursue infringement claims against
Ovation, if it seeks to commercialize Sabril for this
indication. However, we, unlike Ovation and many of our other
competitors, are a relatively small company with comparatively
few resources available to us to engage in costly and protracted
litigation. Moreover, regardless of the outcome, intellectual
property litigation against or by us could significantly disrupt
our
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development and commercialization efforts, divert our
managements attention and quickly consume our financial
resources.
In addition, if third parties file patent applications or issue
patents claiming technology that is also claimed by us in
pending applications, we may be required to participate in
interference proceedings with the U.S. Patent Office or in other
proceedings outside the U.S., including oppositions, to
determine priority of invention or patentability. Even if we are
successful in these proceedings, we may incur substantial costs,
and the time and attention of our management and scientific
personnel will be diverted from product development or other
more productive matters.
Risks Related to Government Regulation
We have not received regulatory approval in the United States
or any foreign jurisdiction for the commercial sale of any of
our product candidates. The regulatory approval process is
lengthy, and we may not be able to obtain all of the regulatory
approvals required to manufacture and commercialize our product
candidates.
We do not have any products that have been approved for
commercialization. We will not be able to commercialize our
products until we have obtained the requisite regulatory
approvals from federal, state and local government authorities.
To obtain regulatory approval of a product candidate, we must
demonstrate to the satisfaction of the applicable regulatory
agency that such product candidate is safe and effective for its
intended uses. The type and magnitude of the testing required
for regulatory approval varies depending on the product
candidate and the disease or condition for which it is being
developed. In addition, we must show that the facilities used to
produce the product candidate are in compliance with applicable
manufacturing regulations, which under FDA regulations are
called current Good Manufacturing Practices, or cGMP. In
general, these requirements mandate that manufacturers follow
elaborate design, testing, control, documentation and other
quality assurance procedures throughout the entire manufacturing
process. The process of obtaining regulatory approvals typically
takes several years and requires the expenditure of substantial
capital and other resources. Despite the time, expense and
resources invested by us in the approval process, we may not be
able to demonstrate that our product candidates are safe and
effective, in which event we would not receive the regulatory
approvals required to market them.
The FDA and other regulatory authorities generally approve
products for particular indications. While our current focus is
on the development of CPP-109 as a treatment of cocaine
addiction, we also intend to pursue CPP-109 as a treatment for
addictions to other substances involving heightened dopamine
levels, such as methamphetamine, nicotine, prescription pain
medications, alcohol and marijuana, and related addictive
disorders such as obesity and compulsive gambling. CPP-109 may
not be approved for any or all of the indications that we
request, which would limit the indications for which we can
promote it and adversely impact our ability to generate
revenues. If the approvals we obtain are limited, we may be
required to conduct costly, post-marketing follow-up studies.
Regulatory agencies can delay, limit or deny approval of a
product for many reasons, including the following:
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regulatory officials might interpret data from non-clinical and
clinical testing in different ways than we interpret it and
conclude that the product candidate is not safe and effective; |
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regulatory agencies might not approve our manufacturing
processes or facilities or the processes or facilities of our
contract manufacturers and raw material suppliers; or |
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regulatory agencies might change their approval polices or adopt
new regulations, which could delay approval and add significant
additional costs. |
Any delay or failure by us to obtain regulatory approvals for
our product candidates would adversely affect our ability to
generate revenues from them and could impose significant
additional costs on us. Regulatory
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approval in one country does not ensure regulatory approval in
another, but a failure or delay in obtaining regulatory approval
in one country may negatively impact the regulatory approval
process in others.
The FDA has granted Fast Track designation for CPP-109 to treat
cocaine addiction. Fast Track designation means, among other
things, that the FDA may initiate review of sections of an NDA
before the application is complete in order to expedite
regulatory review of the application. However, Fast Track
designation does not accelerate clinical trials, nor does it
mean that the regulatory requirements necessary to obtain an
approval are less stringent. Our Fast Track designation does not
guarantee that we will qualify for, or be able to take advantage
of, priority review procedures following a submission of an NDA.
Additionally, our Fast Track designation may be withdrawn by the
FDA if the FDA believes that the designation is no longer
supported by data from our clinical development program, or if a
competitors product is approved for the indication we are
seeking.
If our non-clinical or clinical trials are unsuccessful or
significantly delayed, our ability to commercialize our products
will be impaired.
Before we can obtain regulatory approval for the sale of our
product candidates, we must conduct, at our own expense,
extensive non-clinical tests to demonstrate the safety of
CPP-109 in animals and
clinical trials to demonstrate the safety and efficacy of
CPP-109 in humans.
Non-clinical testing is expensive, difficult to design and
implement, can take several years to complete and is uncertain
as to outcome. Our non-clinical tests may produce negative or
inconclusive results, and on the basis of such results, we may
decide, or regulators may require us, to halt ongoing clinical
trials or conduct additional non-clinical testing.
In the United States, where vigabatrin is not currently approved
for use, we intend to commence during the fourth quarter of 2006
a Phase II clinical trial to assess the efficacy of using
CPP-109 as a treatment for cocaine addiction. We may also
develop and implement additional studies (including a U.S. Phase
III clinical trial, if required) in order to seek approval to
commercialize CPP-109 for the treatment of cocaine addiction.
However, even if the results of a clinical trial are promising,
a drug may subsequently fail to meet the safety and efficacy
standards required to obtain regulatory approvals. Future
clinical trials for CPP-109 may not be successfully completed or
may take longer than anticipated because of any number of
factors, including potential delays in the start of the trial,
an inability to recruit clinical trial participants at the
expected rate, failure to demonstrate safety and efficacy,
unforeseen safety issues, or unforeseen governmental or
regulatory delays.
Our U.S. Phase II clinical trial or any other study we might
develop and implement may not be completed in a timely manner or
at all. CPP-109 may not be found to be safe and effective, and
may not be approved by regulatory authorities for the proposed
indication, especially in light of known side effects associated
with the drug. Further, regulatory authorities and IRBs that
must approve and monitor the safety of each clinical study may
suspend a clinical study at any time if the patients
participating in such study are deemed to be exposed to any
unacceptable health risk. We may also choose to suspend clinical
trials and studies if we become aware of any such risks. We
might encounter problems in our U.S. Phase II clinical trial or
in other future studies we may conduct, including problems
associated with VFDs or other side effects that will cause us,
regulatory authorities or IRBs to delay or suspend such trial or
study.
We have entered into an agreement with a contract manufacturer
to formulate and manufacture CPP-109 for use in our U.S. Phase
II clinical trial. In the event that sufficient quantities of
CPP-109 are not available by the time we begin the trial, we
intend to use Sabril in our clinical trials and subsequently
demonstrate the bioequivalence of CPP-109 to Sabril. If we are
unable to demonstrate that CPP-109 is bioequivalent to Sabril,
the FDA may require us to repeat or conduct additional Phase I
or Phase II clinical trials using CPP-109. This would result in
significant delays in our product development activities, which
would have a material adverse effect on our business.
We may encounter difficulties in our clinical trials due to the
nature of the addiction mechanism and our resulting target
patient population. We do not know how long it will take to
recruit patients for our Phase II
17
clinical trial. Trial participants will be required to meet
specific clinical standards for cocaine dependence, as specified
in DSM-IV, a set of diagnosis guidelines established for
clinical professionals. Further, participants must meet DSM-IV
criteria only with respect to cocaine dependence, and will not
be eligible to participate in our study if they meet the DSM-IV
criteria for dependence with respect to other addictive
substances. Because addicts are typically addicted to multiple
substances, we may not be able to recruit a sufficient number of
eligible participants within our anticipated timeframe or at
all. In addition, due to the neurological and physiological
mechanisms and implications of substance addiction, and as
evidenced by our pilot studies of vigabatrin, it is likely that
many of our clinical trial participants will not complete the
trial. An unusually low rate of completion will present
challenges, such as determining the statistical significance of
trial results.
In other countries where CPP-109 or any other product we develop
may be marketed, we will also be subject to regulatory
requirements governing human clinical studies and marketing
approval for drugs. The requirements governing the conduct of
clinical studies, product licensing, pricing and reimbursement
varies widely from country to country.
We have not conducted any non-clinical testing for CPP-109
and we are not certain at this time which non-clinical tests the
FDA will require with respect to any NDA that we may file.
The FDA may require us to conduct extensive non-clinical testing
before approving our product. Some testing, such as
carcinogenicity studies, may require several years to conduct.
We do not know whether any non-clinical tests will begin as
planned, will need to be restructured or will be completed on
schedule, if at all. We do not know whether the non-clinical
tests, if conducted, will be acceptable to the FDA.
If the FDA does not accept an NDA from us based on the
results of our Phase II clinical trial, our development and
commercialization activities would be significantly delayed.
Generally, the process of seeking approval of an NDA requires
multiple pivotal trials, including a Phase II clinical
trial and a Phase III clinical trial. However, if the
results of our Phase II clinical trial in the United States and
the results of the clinical trial we are supporting in Mexico
are compelling, we may elect to file an NDA on the basis of
those studies and seek FDA review under its accelerated approval
process. Accelerated approval provides the opportunity for
regulatory approval based on achieving endpoints in our current
studies, which are designed to show the safety and efficacy of
CPP-109 to the FDAs satisfaction. However, we may not
succeed in reaching our endpoints, or may not successfully
complete the Phase II trial. Even if the Phase II trial is
successfully completed, the FDA may not accept an NDA on the
basis of a single study or review the NDA under the accelerated
approval process. Failure to obtain review on the basis of a
single study or to obtain accelerated approval could require us
to complete additional and more extensive clinical trials, which
would be costly and time-consuming and would delay potential FDA
approval of CPP-109 for several years. Even if we are able to
obtain FDA review under its accelerated approval process, we
might not be granted full approval for commercial sale. Further,
the FDA may require us to conduct additional post-approval
clinical studies as a condition of any approval granted.
If our third-party suppliers or contract manufacturers do not
maintain high standards of manufacturing in accordance with cGMP
and other manufacturing regulations, our development and
commercialization activities could suffer significant
interruptions or delays.
We rely, and intend to continue to rely, on third-party
suppliers and contract manufacturers to provide us with
materials for our clinical trials and commercial-scale
production of our products. These suppliers and manufacturers
must continuously adhere to cGMP as well as any applicable
corresponding manufacturing regulations outside of the U.S. In
complying with these regulations, we and our third-party
suppliers and contract manufacturers must expend significant
time, money and effort in the areas of design and development,
testing, production, record-keeping and quality control to
assure that our products meet applicable specifications and
other regulatory requirements. Failure to comply with these
requirements could result in an enforcement action
18
against us, including the seizure of products and shutting down
of production. Any of these third-party suppliers or contract
manufacturers will also be subject to audits by the FDA and
other regulatory agencies. If any of our third-party suppliers
or contract manufacturers fail to comply with cGMP or other
applicable manufacturing regulations, our ability to develop and
commercialize our products could suffer significant
interruptions and delays.
Reliance on third-party manufacturers entails risks to which we
would not be subject if we manufactured the product ourselves,
including:
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reliance on the third party for regulatory compliance and
quality assurance; |
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limitations on supply availability resulting from capacity and
scheduling constraints of the third parties; |
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impact on our reputation in the marketplace if manufacturers of
our products, once commercialized, fail to meet the demands of
our customers; |
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the possible breach of the manufacturing agreement by the third
party because of factors beyond our control; and |
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the possible termination or nonrenewal of the agreement by the
third party, based on its own business priorities, at a time
that is costly or inconvenient for us. |
If any of our contract manufacturers fail to achieve and
maintain high manufacturing standards, patients using our
product candidates could be injured or die, resulting in product
liability claims, product recalls, product seizures or
withdrawals, delays or failures in testing or delivery, cost
overruns or other problems that could seriously harm our
business or profitability.
Post-approval marketing of our products will be subject to
substantial government regulation. Failure to comply with these
regulations could result in fines and withdrawal of
approvals.
Even if our products receive regulatory approvals, we will be
subject to extensive ongoing government regulation. The FDA or
other regulatory authorities may impose additional limitations
on the indicated uses for which a product may be marketed,
subsequently withdraw approval or take other actions against us
or our products for many reasons, including subsequent
discoveries of previously unknown problems or safety issues with
the product. Also, based on subsequent events or other
circumstances that may come to our attention, we may voluntarily
take action to limit the marketing or use of one or more of our
products.
In particular, we are subject to inspection and market
surveillance by regulatory authorities for compliance with
regulations that prohibit the promotion of a medical product for
a purpose or indication other than those for which approval has
been granted. While a medical product manufacturer may not
promote a product for such off-label use, doctors
are allowed, in the exercise of their professional judgment in
the practice of medicine, to use a product in ways not approved
by regulatory authorities. A pattern of widespread off-label use
could cause regulatory authorities to scrutinize our marketing
activities.
Regulatory authorities have broad enforcement power, and any
failure by us to comply with manufacturing or marketing
regulations could result in penalties, including warning
letters, fines, total or partial suspension of production,
product recalls or seizures, withdrawals of previously approved
marketing approvals or applications, and criminal prosecutions.
Substantial and changing healthcare regulations by state and
federal authorities could reduce or eliminate our commercial
opportunity in the addiction treatment industry.
Healthcare organizations, public and private, continue to change
the manner in which they operate and pay for services. These
organizations have had to adapt to extensive and complex
federal, state and local laws, regulations and judicial
decisions governing activities including drug manufacturing and
marketing. Addition-
19
ally, the healthcare industry in recent years has been subject
to increasing levels of government regulation of reimbursement
rates and capital expenditures. We believe that the industry
will continue to be subject to increasing regulation, as well as
political and legal action, as future proposals to reform the
healthcare system are considered by Congress and state
legislatures. Any new legislative initiatives, if enacted, may
further increase government regulation of or other involvement
in healthcare, lower reimbursement rates and otherwise change
the operating environment for healthcare companies. We cannot
predict the likelihood of all future changes in the healthcare
industry in general, or the addiction treatment industry in
particular, or what impact they may have on our earnings,
financial condition or business. Government regulations
applicable to our proposed products or the interpretation
thereof might change and thereby prevent us from marketing some
or all of our products and services for a period of time or
indefinitely.
Risks Related to this Offering and Our Common Stock
We are highly dependent on our small number of key personnel
and advisors.
We are highly dependent on our officers, on our Board of
Directors and on our scientific advisors. The loss of the
services of any of these individuals could significantly impede
the achievement of our scientific and business objectives. Other
than employment agreements that will become effective upon
completion of this offering with Patrick J. McEnany, our
Chairman and Chief Executive Officer, and Jack Weinstein, our
Chief Financial Officer, with respect to their services, and the
consulting agreements we have with one of our board members and
one of our scientific advisors, we have no employment or
retention agreements with our officers, directors or scientific
advisors. If we lose the services of any of our existing
officers, directors or scientific advisors, or if we were unable
to recruit qualified replacements on a timely basis for persons
who leave our employ, our efforts to develop CPP-109 or other
products might be significantly delayed. We do not carry key-man
insurance on any of our personnel.
We have relationships with our scientific advisers and
collaborators at academic and other institutions. Such
individuals are employed by entities other than us and may have
commitments to, or consulting advisory contracts with, such
entities that may limit their availability to us. Although each
scientific advisor and collaborator has agreed not to perform
services for another person or entity that would create an
appearance of a conflict of interest, the Chairman of our
Scientific Advisory Board, Stephen L. Dewey, Ph.D., is a member
of the Brookhaven staff and is actively involved in
Brookhavens investigation of the neurological mechanisms
involved in the addiction process. His research might result in
pharmaceutical products that are competitive with, or superior
to, vigabatrin. Similarly, other similar conflicts may arise
from the work in which other scientific advisers and/or
collaborators are involved.
We are effectively controlled by our Chairman and Chief
Executive Officer.
Prior to this offering, our Chairman and Chief Executive
Officer, Patrick J. McEnany, beneficially owns approximately
40.0% of our outstanding common stock. Following this offering,
it is likely that Mr. McEnany will continue to own sufficient
shares of our common stock to be in a position to significantly
influence or exert control over the outcome of most stockholder
actions, including the election of all directors. As a result,
Mr. McEnany could take actions that might not be considered
by other stockholders to be in their best interest.
There has been no prior market for our common stock, and it
may trade at prices below the initial public offering price.
Prior to this offering, there has been no public market for our
common stock. We cannot predict the extent to which a trading
market for our common stock will develop or be sustained after
this offering. The initial public offering price will be
determined by negotiations between us and the representatives of
the underwriters based on factors that may not be indicative of
future performance, and may not bear any relationship to the
price
20
at which our common stock will trade upon completion of this
offering. You may be unable to sell your shares of common stock
at or above the initial public offering price.
The trading price of the shares of our common stock could be
highly volatile.
The trading price of the shares could be highly volatile in
response to various factors, many of which are beyond our
control, including:
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developments concerning our clinical studies and trials; |
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announcements of product development failures and successes by
us or our competitors; |
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new products introduced or announced by us or our competitors; |
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changes in reimbursement levels; |
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changes in financial estimates by securities analysts; |
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actual or anticipated variations in operating results; |
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expiration or termination of licenses (particularly our license
from Brookhaven), research contracts or other collaboration
agreements; |
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conditions or trends in the regulatory climate and the
biotechnology and pharmaceutical industries; |
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intellectual property, product liability or other litigation
against us; |
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changes in the market valuations of similar companies; and |
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sales of shares of our common stock, particularly sales by our
officers, directors and significant stockholders, or the
perception that such sales may occur. |
In addition, equity markets in general, and the market for
emerging pharmaceutical and life sciences companies in
particular, have experienced substantial price and volume
fluctuations that have often been unrelated or disproportionate
to the operating performance of companies traded in those
markets. In addition, changes in economic conditions in the
United States, Europe or globally could impact our ability to
grow profitably. Adverse economic changes are outside our
control and may result in material adverse impacts on our
business or financial results. These broad market and industry
factors may materially affect the market price of our shares,
regardless of our own development and operating performance. In
the past, following periods of volatility in the market price of
a companys securities, securities class-action litigation
has often been instituted against that company. Such litigation,
if instituted against us, could cause us to incur substantial
costs and divert managements attention and resources,
which could have a material adverse effect on our business,
financial condition and results of operations.
You will experience immediate and substantial dilution as a
result of this offering and may experience additional dilution
in the future.
If you purchase common stock in this offering, you will pay more
for your shares than the amounts paid by existing stockholders
for their shares in prior offerings. In addition, you will
experience immediate and substantial dilution insofar as the
initial public offering price will be substantially greater than
the tangible book value per share of our outstanding common
stock after giving effect to this offering.
We have broad discretion in the use of the proceeds from this
offering. Our use of the offering proceeds may not yield a
favorable return on your investment.
We expect to use the net proceeds from this offering to develop
and fund clinical studies of our product candidates and for
general corporate purposes, including the potential acquisition
or in-license of products that
21
may have potential applications in treating addiction. Our
management has broad discretion over how these proceeds are used
and could spend the proceeds in ways with which you do not
agree. Pending the use of the proceeds in this offering, we plan
to invest them. However, the proceeds may not be invested
effectively or in a manner that yields a favorable or any
return, and consequently, this could result in financial losses
that could have a material adverse effect on our business, cause
the price of our common stock to decline and delay the
development of our product candidates.
Delaware law and our certificate of incorporation and by-laws
contain provisions that could delay and discourage takeover
attempts that stockholders may consider favorable.
Certain provisions of our certificate of incorporation and
by-laws, and applicable provisions of Delaware corporate law,
may make it more difficult for or prevent a third party from
acquiring control of us or changing our board of directors and
management. These provisions include:
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the ability of our board of directors to issue preferred stock
with voting or other rights or preferences; |
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limitations on the ability of stockholders to amend our charter
documents, including stockholder supermajority voting
requirements; |
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the inability of stockholders to act by written consent or to
call special meetings; |
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requirements that special meetings of our stockholders may only
be called by the board of directors; and |
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advance notice procedures our stockholders must comply with in
order to nominate candidates for election to our board of
directors or to place stockholders proposals on the agenda
for consideration at meetings of stockholders. |
In addition, Section 203 of the Delaware General
Corporation Law generally prohibits us from engaging in a
business combination with any person who owns 15% or more of our
common stock for a period of three years from the date such
person acquired such common stock, unless board or stockholder
approval is obtained. These provisions could make it difficult
for a third party to acquire us, or for members of our board of
directors to be replaced, even if doing so would be beneficial
to our stockholders.
Any delay or prevention of a change of control transaction or
changes in our board of directors or management could deter
potential acquirors or prevent the completion of a transaction
in which our stockholders could receive a substantial premium
over the then current market price for their shares.
Future sales of our common stock may cause our stock price to
decline.
Sales of a substantial number of shares of our common stock in
the public market could occur at any time. These sales, or the
perception in the market that the holders of a large number of
shares intend to sell shares, could reduce the market price of
our common stock. We also intend to register all shares of
common stock that we may issue under our 2006 Stock Incentive
Plan and under our previously granted stock options.
We do not intend to pay cash dividends on our common stock in
the foreseeable future.
We have never declared or paid any cash dividends on our common
stock or other securities, and we currently do not anticipate
paying any cash dividends in the foreseeable future.
Accordingly, our stockholders will not realize a return on their
investment unless the trading price of our common stock
appreciates. Our common stock may not appreciate in value after
the offering and may not even maintain the price at which
investors purchased shares.
22
FORWARD-LOOKING STATEMENTS
Certain statements made in this prospectus are
forward-looking statements, including statements
regarding our expectations, beliefs, plans or objectives for
future operations and anticipated results of operations. For
this purpose, any statements contained herein that are not
statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the
words, believes, anticipates,
proposes, plans, expects,
intends, may and similar expressions are
intended to identify forward-looking statements. Such statements
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, performance or achievements
to be materially different from any future results, performance
or achievements expressed or implied by such forward-looking
statements. The forward-looking statements made in this
prospectus are based on current expectations that involve
numerous risks and uncertainties, including but not limited to
the following:
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our ability to successfully complete clinical trials required to
file and obtain approval of an NDA for the commercialism of
CPP-109, and the timing of any such filing and approval; |
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our ability to protect our intellectual property rights; |
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market acceptance of any products as to which we may receive
approval for commercialization; |
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the ability of others to develop, obtain approval of, and
commercialize competitive products; and |
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the information contained in the Risk Factors
section. |
Our current plans and objectives are based on assumptions
involving the growth and expansion of our business. Although we
believe that our assumptions are reasonable, any of our
assumptions could prove inaccurate. In light of the significant
uncertainties inherent in the forward-looking statements made in
this prospectus, which reflect our views only as of the date of
this prospectus, you should not place undue reliance upon such
statements.
23
USE OF PROCEEDS
The net proceeds to us from the sale of the securities offered
hereby are estimated to be approximately
$ ,
assuming an initial public offering price of
$ ,
and after deducting underwriting discounts and commissions and
estimated offering expenses. Each $1.00 increase
(decrease) in the assumed initial public offering price of
$ per
share would increase (decrease) the net proceeds to us from
this offering by approximately
$ ,
assuming that the number of shares offered by us, as set forth
on the cover page of this prospectus, remains the same.
Depending on market conditions at the time of pricing of this
offering and other considerations, we may sell fewer or more
shares than the number set forth on the cover page of this
prospectus. If the underwriters exercise their over-allotment
option in full, we estimate that our net proceeds will be
approximately
$ .
We expect to use the net proceeds of this offering as follows:
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approximately $7.0 million to fund our U.S. Phase II
clinical trial to evaluate CPP-109 for the treatment of cocaine
addiction; |
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approximately $7.5 million to fund a U.S. Phase III
clinical trial to evaluate CPP-109 for the treatment of cocaine
addiction, if required; |
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up to approximately $4.0 million to fund other costs
relating to our filing of an NDA for CPP-109 to treat cocaine
addiction, including any non-clinical studies that may be
required; |
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approximately $3.5 million to begin clinical studies and
trials to evaluate CPP-109 as a treatment for methamphetamine
addiction; |
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approximately $2.5 million to begin clinical studies and
trials to evaluate CPP-109 as a treatment for nicotine addiction; |
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approximately $3.0 million to begin development of clinical
studies and trials needed to commercialize CPP-109 in Europe; and |
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the balance for general corporate purposes. |
The above amounts represent our estimate of the costs to fund
the above clinical programs. However, we cannot assure you that
we will be able to complete our trials with the amounts
specified, and the costs we incur may be well in excess of the
above amounts.
In addition, we may use a portion of the net proceeds from this
offering to acquire or license one or more products that show
promise in treating addiction. However, we currently have no
commitments, agreements, or understandings relating to any such
acquisition.
We believe that the net proceeds from this offering, together
with our existing cash, cash equivalents and short-term
investments, will be sufficient to meet our projected operating
requirements for the next 30 months.
The allocation of the net proceeds of this offering described
above represents our best current estimate of our projected
operating requirements. However, the exact amount and timing of
our expenditures will depend on several factors, including the
success of our commercialization activities and the progress of
our clinical trials and other development efforts as well as the
amount of cash used in our operations. Accordingly, our
management will have broad discretion in the application of the
net proceeds and investors will be relying on the judgment of
our management regarding the application of the proceeds of this
offering. We reserve the right to change the use of these
proceeds as a result of certain contingencies such as the
results of our commercialization efforts, competitive
developments, opportunities to acquire or in-license products,
and other factors.
Pending the uses described above, we plan to invest the net
proceeds of this offering in short and medium-term, interest
bearing obligations, investment-grade instruments, certificates
of deposit or direct or guaranteed obligations of the U.S.
government.
24
DIVIDEND POLICY
We have not in the past and do not intend in the foreseeable
future to pay cash dividends. We expect to retain future
earnings, if any, to fund the development and growth of our
business. The declaration of dividends is subject to the
discretion of our board of directors and will depend on various
factors, including our results of operations, financial
condition, future prospects and any other factors deemed
relevant by our board of directors. In addition, the terms of
any future debt or credit facility may preclude us from paying
dividends on our common stock.
25
CAPITALIZATION
The following table sets forth our capitalization as of
June 30, 2006:
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on an actual basis, after giving effect to the automatic
conversion upon the closing of this offering of our outstanding
Series A preferred stock into 700,000 shares of our common
stock; |
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on a pro forma basis to give effect to our completion on
July 24, 2006 of a private placement of 7,644 shares
of our Series B Preferred Stock from which we received net
proceeds of $3,225,140, the automatic conversion of these
Series B preferred shares upon the closing of this offering
into 764,400 shares of our common stock, and the issuance of
97,500 shares of our common stock in July 2006 relating to
services performed for us by certain of our consultants and
scientific advisors during 2004, 2005 and the first six months
of 2006; and |
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on a pro forma as adjusted basis to give further effect to our
sale
of shares
of common stock in this offering at an assumed initial public
offering price of
$ per
share and our receipt of an estimated
$ in
net proceeds therefrom, after deducting underwriting discounts
and commissions and estimated offering expenses to be paid by us. |
This table should be read in conjunction with
Managements Discussion and Analysis of Financial
Condition and Results of Operations, and the financial
statements and the related notes and schedules thereto, included
elsewhere in this prospectus.
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June 30, 2006 | |
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Pro forma as | |
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Actual | |
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Pro forma | |
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adjusted(1) | |
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Cash and cash equivalents
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$ |
324,154 |
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$ |
3,549,294 |
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$ |
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Stockholders equity (deficit)
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Common stock, $.01 par value, 100,000,000 shares authorized;
issued and outstanding: 5,420,000 shares actual, 6,281,900
shares pro forma;
and shares
pro forma as adjusted
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$ |
54,200 |
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$ |
62,819 |
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$ |
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Preferred stock, $.01 par value, 5,000,000 shares authorized; no
shares
outstanding(2)
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Additional paid-in capital
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3,573,147 |
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6,984,668 |
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Accumulated deficit
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(3,696,585 |
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(3,696,585 |
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Total stockholders equity (deficit)
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(69,238 |
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3,350,902 |
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Total capitalization
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$ |
(69,238 |
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$ |
3,350,902 |
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$ |
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(1) |
Each $1.00 increase (decrease) in the assumed initial
public offering price of
$ per
share would increase (decrease) each of cash and cash
equivalents, additional paid-in capital, total
shareholders equity and total capitalization by
approximately $ million, assuming that the
number of shares offered by us, as set forth on the cover page
of this prospectus, remains the same. Depending on market
conditions at the time of pricing of this offering and other
considerations, we may sell fewer or more shares than the number
set forth on the cover page of this prospectus. The pro forma as
adjusted information discussed above is illustrative only and
following the completion of this offering will be adjusted based
on the actual initial public offering price and other terms of
this offering determined at pricing. |
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(2) |
Gives effect to the automatic conversion at the closing of this
offering of our outstanding Series A and Series B
preferred stock into an aggregate of 1,464,400 shares of our
common stock. |
The above table excludes 1,603,000 shares of common stock
underlying options outstanding on the date of this prospectus at
a weighted average exercise price of $1.67 per share.
26
DILUTION
If you invest in our common stock, your interest will be diluted
immediately to the extent of the difference between the initial
public offering price per share you pay in this offering and the
pro forma as adjusted net tangible book value per share of our
common stock immediately after this offering. Our pro forma net
tangible book value as of June 30, 2006, was $3,350,902, or
$0.53 per share. Pro forma net tangible book value per share
represents our tangible assets less total liabilities divided by
the 6,281,900 shares of our common stock outstanding, after
giving pro forma effect to our sale in July 2006 of 7,644 shares
of Series B Preferred Stock for net proceeds of $3,225,140;
the issuance in July 2006 of 97,500 shares of our common stock
for services; and the automatic conversion, upon completion of
this offering, of all outstanding shares of our convertible
preferred stock into an aggregate of 1,464,400 shares of our
common stock.
After giving effect to the sale
of shares
of common stock in this offering, at an assumed initial public
offering price of
$ per
share, and after deducting the estimated offering expenses, our
pro forma as adjusted net tangible book value at June 30,
2006 would have been approximately
$ ,
or approximately
$ per
share of common stock. This represents an immediate increase in
net tangible book value of approximately
$ to
our existing stockholders and an immediate dilution of
$ per
share to new investors in this offering.
The following table illustrates this calculation.
|
|
|
|
|
|
|
|
|
|
Assumed initial public offering price per share
|
|
|
|
|
|
$ |
|
|
|
Pro forma net tangible book value per share as of June 30,
2006
|
|
$ |
0.53 |
|
|
|
|
|
|
Increase per share attributable to this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net tangible book value per share after this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilution per share to new investors
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Each $1.00 increase (decrease) in the assumed initial
offering price of
$ per
share would increase (decrease) our pro forma as adjusted
net tangible book value by approximately
$ ,
or approximately
$ per
share, and dilution to new investors by
$ per
share, assuming that the number of shares offered by us, as set
forth on the cover page of this prospectus, remains the same.
Depending on market conditions at the time of pricing of this
offering and other considerations, we may sell fewer or more
shares than the number set forth on the cover page of this
prospectus.
If the underwriters exercise their over-allotment option in
full, our pro forma as adjusted net tangible book value as of
June 30, 2006 will increase to approximately
$ per
share, representing an increase to existing stockholders of
approximately
$ per
share, and there will be an immediate dilution of approximately
$ per
share to new investors.
The following table summarizes, on a pro forma as adjusted basis
as of June 30, 2006, the total number of shares of our
common stock purchased from us and the total consideration and
average price per share paid by existing stockholders and by new
investors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares Purchased | |
|
Total Consideration Paid | |
|
|
|
|
| |
|
| |
|
Average Price Per | |
|
|
Number | |
|
Percent | |
|
Amount | |
|
Percent | |
|
Share | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Existing stockholders
|
|
|
6,281,900 |
|
|
|
% |
|
|
$ |
5,334,140 |
|
|
|
% |
|
|
$ |
0.85 |
|
New investors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
|
100% |
|
|
$ |
|
|
|
|
100% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Each $1.00 increase (decrease) in the assumed initial
public offering price of
$ per
share would increase (decrease) total consideration paid by
new investors, total consideration paid by all stockholders and
the average price per share paid by all stockholders by
$ ,
$ and
$ ,
respectively,
27
assuming that the number of shares offered by us, as set forth
on the cover page of this prospectus, remains the same.
Depending on market conditions at the time of pricing of this
offering and other considerations, we may sell fewer or more
shares than the number set forth on the cover page of this
prospectus.
If the underwriters exercise their over-allotment option in
full, the percentage of shares held by existing stockholders
will decrease to
approximately %,
and the number of shares held by new investors will increase
to ,
or
approximately %.
28
SELECTED FINANCIAL DATA
The following table sets forth our selected financial data
for each of the three years ended December 31, 2005 and as
of December 31, 2005 and 2004, which have been derived from
our audited financial statements included elsewhere in this
prospectus. In addition, the table includes selected financial
data for the six months ended June 30, 2006 and 2005, and
as of June 30, 2006, which have been derived from our
unaudited interim financial statements included elsewhere in
this prospectus. The table also includes unaudited data for the
year ended December 31, 2002 and as of December 31,
2003 and 2002, which are not included in this prospectus. Our
predecessor company was incorporated in 2002. It is important
that you read this information together with
Managements Discussion and Analysis of Financial
Condition and Results of Operations, Risk
Factors and our financial statements and the related notes
and schedules to these financial statements beginning on Page
F-1 of this prospectus. The results presented below are not
necessarily indicative of results to be expected in any future
periods.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from | |
|
Cumulative period | |
|
|
|
|
|
|
January 4, 2002 | |
|
from January 4, | |
|
|
Six Months Ended June 30, | |
|
Year Ended December 31, | |
|
(date of inception) | |
|
2002 (date of | |
|
|
| |
|
| |
|
through | |
|
inception) through | |
|
|
2006 | |
|
2005 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
December 31, 2002 | |
|
June 30, 2006 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(unaudited) | |
|
|
|
|
|
|
|
(unaudited) | |
|
(unaudited) | |
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
191,639 |
|
|
|
187,394 |
|
|
|
290,139 |
|
|
|
83,421 |
|
|
|
172,996 |
|
|
|
61,847 |
|
|
|
800,042 |
|
|
General and administrative
|
|
|
242,194 |
|
|
|
126,811 |
|
|
|
359,279 |
|
|
|
164,704 |
|
|
|
165,483 |
|
|
|
118,265 |
|
|
|
1,049,925 |
|
|
Non-cash compensation
(2)
|
|
|
241,125 |
|
|
|
1,013,375 |
|
|
|
1,172,750 |
|
|
|
294,833 |
|
|
|
95,833 |
|
|
|
75,833 |
|
|
|
1,880,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
674,958 |
|
|
|
1,327,580 |
|
|
|
1,822,168 |
|
|
|
542,958 |
|
|
|
434,312 |
|
|
|
255,945 |
|
|
|
3,730,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(674,958 |
) |
|
|
(1,327,580 |
) |
|
|
(1,822,168 |
) |
|
|
(542,958 |
) |
|
|
(434,312 |
) |
|
|
(255,945 |
) |
|
|
(3,730,341 |
) |
Interest income
|
|
|
8,133 |
|
|
|
5,908 |
|
|
|
16,788 |
|
|
|
3,138 |
|
|
|
5,697 |
|
|
|
|
|
|
|
33,756 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(666,825 |
) |
|
|
(1,321,672 |
) |
|
|
(1,805,380 |
) |
|
|
(539,820 |
) |
|
|
(428,615 |
) |
|
|
(255,945 |
) |
|
|
(3,696,585 |
) |
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(666,825 |
) |
|
$ |
(1,321,672 |
) |
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
|
$ |
(255,945 |
) |
|
$ |
(3,696,585 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.14 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding basic and diluted
|
|
|
4,720,000 |
|
|
|
3,767,033 |
|
|
|
4,252,219 |
|
|
|
2,000,000 |
|
|
|
2,000,000 |
|
|
|
1,616,438 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
Pro forma June 30, | |
|
June 30, | |
|
| |
|
|
2006(1) | |
|
2006 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(unaudited) | |
|
(unaudited) | |
|
|
|
|
|
|
|
(unaudited) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
3,549,294 |
|
|
$ |
324,154 |
|
|
$ |
771,127 |
|
|
$ |
183,911 |
|
|
$ |
416,262 |
|
|
$ |
107,089 |
|
Working capital
|
|
|
3,117,624 |
|
|
|
(107,516 |
) |
|
|
428,579 |
|
|
|
116,111 |
|
|
|
362,563 |
|
|
|
40,388 |
|
Total assets
|
|
|
3,590,253 |
|
|
|
365,113 |
|
|
|
789,450 |
|
|
|
185,376 |
|
|
|
416,262 |
|
|
|
111,589 |
|
Total liabilities
|
|
|
434,351 |
|
|
|
434,351 |
|
|
|
342,988 |
|
|
|
67,800 |
|
|
|
53,699 |
|
|
|
66,701 |
|
Stockholders equity
|
|
|
3,350,902 |
|
|
|
(69,238 |
) |
|
|
446,462 |
|
|
|
117,576 |
|
|
|
362,563 |
|
|
|
44,888 |
|
|
|
(1) |
Pro forma gives effect to our completion of a private placement
on July 24, 2006 in which we received net proceeds of $3,225,140
and to the issuance in July 2006 of 97,500 shares of our common
stock to our consultants and scientific advisors for services
rendered during 2004, 2005 and the first six months of 2006. |
|
|
(2) |
Represents additional research and development expenses. |
29
MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in
conjunction with our financial statements and the related notes
and schedule thereto appearing elsewhere in this prospectus.
This discussion and analysis may contain forward-looking
statements based upon current expectations that involve risks
and uncertainties. Our actual results may differ materially as a
result of various factors, including those set forth in
Risk Factors or elsewhere in this prospectus.
Overview
We are a specialty pharmaceutical company focused on the
development and commercialization of prescription drugs for the
treatment of drug addiction. Our initial product candidate is
CPP-109, which is based on the chemical compound
gamma-vinyl-GABA, commonly referred to as vigabatrin.
We have a small management team and very few employees. This has
resulted in low general and administrative expenses and overhead
relative to other companies of a similar size at a similar stage
of development. We have brought together a group of consultants
and a scientific advisory board whose members we believe are
among the most respected researchers in the field of addiction
therapy. We have also benefited from the extensive early-stage
research by Brookhaven studying the use of vigabatrin to treat
addiction. This has allowed us to move our product development
efforts forward to the point we are at today without having to
build a large infrastructure or to expend significant financial
resources for basic research.
The successful development of CPP-109 or any other product we
may develop, acquire, or license is highly uncertain. We cannot
reasonably estimate or know the nature, timing, or estimated
expenses of the efforts necessary to complete the development
of, or the period in which material net cash inflows are
expected to commence due to the numerous risks and uncertainties
associated with developing, such products, including the
uncertainty of:
|
|
|
|
|
the scope, rate of progress and expense of our clinical trials
and our other product development activities; |
|
|
|
the results of future clinical trials, and the number of
clinical trials (and the scope of such trials) that will be
required to seek and obtain approval of an NDA for CPP-109; and |
|
|
|
the expense of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights. |
Research and development expenses, in the aggregate, represented
approximately 44%, 45%, 34% and 51% of our total operating
expenses (excluding non-cash compensation) for the six months
ended June 30, 2006 and the years ended December 31,
2005, 2004 and 2003, respectively. Research and development
expenses consist primarily of costs incurred for clinical trials
and development costs related to CPP-109, personnel and related
costs related to our product development activities, and outside
professional fees related to clinical development and regulatory
matters.
We expect that our research and development expenses will
substantially increase as a percentage of our total expenses due
to the estimated expense of our planned U.S. Phase II clinical
trial, and our anticipated costs related to the clinical trial
to be conducted in Mexico, and the ongoing cocaine craving
study. We estimate that we will incur approximately
$18.5 million in expenses, in addition to costs previously
incurred, for our further clinical trials and development costs
for CPP-109 to treat cocaine addiction. These estimates assume
that a U.S. Phase III clinical trial will be required by the FDA
before we are able to obtain approval of an NDA for CPP-109. A
portion of the net proceeds of this offering will be used to
fund all such expenses. We do not expect that we will be able to
commercialize CPP-109 for at least two to three years following
this offering.
30
The above costs include assumptions about events that may be
outside of our control. For example, the FDA could require us to
alter or delay our clinical trials at any stage, which may
significantly increase the costs of that trial, as well as delay
our commercialization of CPP-109 and our future revenue.
Basis of Presentation
We are a development stage company and have had no revenues to
date. We will not have revenues until such time as we receive
approval of CPP-109 and successfully commercialize our product,
of which there can be no assurance.
|
|
|
Research and development expenses |
Our research and development expenses consist of costs incurred
for company-sponsored research and development activities. These
expenses consist primarily of direct and research-related
allocated overhead expenses such as facilities costs, material
supply costs, and medical costs for VFD testing. To date, all of
our research and development resources have been devoted to the
development of CPP-109. We expect this to continue for the
foreseeable future. Costs incurred in connection with research
and development activities are expensed as incurred.
Clinical trial activities require significant expenditures up
front. We anticipate paying significant portions of a
trials cost before any clinical trial begins, and
incurring additional expenditures as the trial progresses and
reaches certain milestones.
|
|
|
Selling and marketing expenses |
We do not currently have any selling or marketing expenses, as
we have not yet received approval for the commercialization of
CPP-109. We expect we will begin to incur such costs upon our
filing of an NDA, so that we can have a sales force in place to
commence our selling efforts immediately upon receiving approval
of such NDA, of which there can be no assurance.
|
|
|
General and administrative expenses |
Our general and administrative expenses consist primarily of
salaries, consulting fees for members of our Scientific Advisory
Board, information technology, and corporate administration
functions. Other costs include administrative facility costs,
regulatory fees, and professional fees for legal and accounting
services.
Non-cash compensation represents additional research and
development expenses, arising from stock grants to several of
our scientific advisors related to our product development
efforts.
We recognize costs related to employee and consultant services
in share-based payment transactions by using the estimated fair
value of the stock at the date of grant, in accordance with
Statement of Financial Accounting Standards
(SFAS) No. 123, Accounting for Stock-Based
Compensation (SFAS 123). As such, the value of such
options is periodically remeasured and income or other expense
is recognized during their vesting terms. The amount of
stock-based compensation expense to be recorded in future
periods may decrease if unvested options, for which deferred
stock compensation has been recorded, are subsequently canceled.
We further account for the issuance of employee stock options
using the intrinsic value method. Accordingly, compensation cost
for stock options issued is measured as the excess, if any, of
the fair value of our common stock at the date of grant over the
exercise price of the options.
31
We have incurred operating losses since inception. As of
December 31, 2005 and 2004, we had net operating loss
carryforwards of $588,326 and $385,928, respectively. The
related deferred tax asset has a 100% valuation allowance as of
December 31, 2005 and 2004, as we believe it is more likely
than not that the deferred tax asset will not be realized. There
are no other significant temporary differences. The net
operating loss carry-forwards will expire at various dates
beginning in 2022 through 2025. If an ownership change, as
defined under Internal Revenue Code Section 382, occurs,
the use of these carry-forwards may be subject to limitation.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and
results of operations are based on our financial statements,
which have been prepared in accordance with accounting
principles generally accepted in the U.S. The preparation of
these financial statements requires us to make judgments,
estimates, and assumptions that affect the reported amounts of
assets and liabilities and the disclosure of contingent assets
and liabilities at the date of the financial statements as well
as the reported revenue and expenses during the reporting
periods. We continually evaluate our judgments, estimates and
assumptions. We base our estimates on the terms of underlying
agreements, our expected course of development, historical
experience and other factors we believe are reasonable based on
the circumstances, the results of which form our
managements basis for making judgments about the carrying
value of assets and liabilities that are not readily apparent
from other sources. Actual results may differ from these
estimates.
The list below is not intended to be a comprehensive list of all
of our accounting policies. In many cases, the accounting
treatment of a particular transaction is specifically dictated
by generally accepted accounting principles, or GAAP. There are
also areas in which our managements judgment in selecting
any available alternative would not produce a materially
different result. Our audited financial statements and the notes
thereto included elsewhere in this prospectus contain accounting
policies and other disclosures required by GAAP.
|
|
|
Non-clinical study and clinical trial expenses |
Research and development expenditures are charged to operations
as incurred. Our expenses related to clinical trials are
expected to be based on actual and estimated costs of the
services received and efforts expended pursuant to contracts
with multiple research institutions and clinical research
organizations that conduct and manage clinical trials on our
behalf. The financial terms of these agreements are subject to
negotiation and vary from contract to contract and may result in
uneven payment flows. Generally, these agreements set forth the
scope of the work to be performed at a fixed fee or unit price.
Payments under the contracts will depend on factors such as the
successful enrollment of patients or the completion of clinical
trial milestones. Expenses related to clinical trials generally
are expected to be accrued based on contracted amounts applied
to the level of patient enrollment and activity according to the
protocol. If timelines or contracts are modified based upon
changes in the clinical trial protocol or scope of work to be
performed, we would be required to modify our estimates
accordingly on a prospective basis.
In December 2004, the FASB issued Statement 123(R),
Accounting for Share-Based Payment, which addresses
the accounting for share-based payment transactions (for
example, stock options and awards of restricted stock) in which
an employer receives employee-services in exchange for equity
securities of the company or liabilities. Statement 123(R)
requires that compensation cost be measured based on the fair
value of the companys equity securities. This proposal
eliminates use of APB Opinion No. 25, Accounting for
Stock Issued to Employees, and requires such transactions
to be accounted for using a fair value-based method and
recording compensation expense rather than optional pro forma
disclosure. The new standard substantially
32
amends SFAS 123. Statement 123(R) requires us to
recognize an expense for the fair value of our unvested
outstanding stock options beginning with our financial
statements for the year ended December 31, 2006. The
Company had no unvested stock options to employees as of
January 1, 2006.
Results of Operations
Revenues. We had no revenues for the six month periods
ended June 30, 2006 and 2005 or for the years ended
December 31, 2005, 2004, and 2003.
Research and Development Expenses. Research and
development expenses for the six months ended June 30, 2006
and 2005 were $191,639 and $187,394, respectively. Research and
development expenses for the years ended December 31, 2005,
2004, and 2003 were $290,139, $83,421, and $172,996,
respectively. Expenses to date include costs associated with the
filing of our IND, payments with respect to clinical studies
that we support, and payments to consultants and members of our
Scientific Advisory Board and other service providers who have
assisted us with respect to these matters.
We expect that research and development activities will increase
substantially as we receive the vigabatrin that will be used in
our upcoming clinical trials, as we pay the costs associated
with our ongoing clinical studies and trials, and as we expand
our product development activities generally. Our historical
research and development expenses have been very low. This is
due to the fact that much of the early stage development costs
associated with the development of vigabatrin to treat addiction
were incurred by Brookhaven in connection with their ongoing
animal studies into the use of vigabatrin to treat addiction. We
benefit from their research by reason of our license.
Selling and Marketing Expenses. We had no selling and
marketing expenses during the six months ended June 30,
2006 and 2005 or during the 2005, 2004 and 2003 fiscal years. We
anticipate that we will begin to incur sales and marketing
expenses when we file an NDA for CPP-109, in order to develop a
sales organization to market CPP-109 and other products we may
develop upon the receipt of required approvals.
General and Administrative Expenses. General and
administrative expenses were $242,194 and $126,811,
respectively, for the six months ended 2006 and 2005. General
and administrative expenses were $359,279, $164,704 and
$165,483, respectively, for the years ended December 31,
2005, 2004 and 2003. General and administrative expenses include
office expenses, legal and accounting fees and travel expenses
for our employees, consultants and members of our Scientific
Advisory Board. We expect general and administrative expenses to
increase in future periods as we incur general non-research
expenses relating to the monitoring and oversight of our
clinical trials, add staff, expand our infrastructure to support
the requirements of being a public company and otherwise expend
funds to continue to develop our business as set forth in this
prospectus.
Non-Cash Compensation. We recorded non-cash compensation
in each of the six month periods in 2006 and 2005, and in 2005,
2004 and 2003. Such non-cash compensation related to shares
issued to several of our consultants and scientific advisors for
services rendered and the value of stock options granted to
non-employees. The majority of non-cash compensation represents
additional research and development expenses. In 2005, 2004,
2003 and the period from January 4, 2002 (date of
inception) through December 31, 2005, we recorded
compensation expense of $1,067,750, $294,833, $75,833 and
$1,514,249, respectively, related to the issuance of stock
options to nonemployees. The weighted average fair value of the
stock options granted in 2005, 2004 and the period from
January 4, 2002 (date of inception) through
December 31, 2005 was $1.66, $1.46 and $1.44, respectively.
There were no stock options granted in 2003.
Interest Income. We reported interest income in all
periods relating to our investment of funds received from our
private placements in 2003 and 2005. All such funds were
invested in short and medium-term interest bearing obligations,
certificates of deposit and direct or guaranteed obligations of
the United States government.
33
Income taxes. We have incurred net operating losses since
inception. Consequently, we have applied a 100% valuation
allowance against our deferred tax asset as we believe that it
is more likely than not that the deferred tax asset will not be
realized.
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily
through the net proceeds of private placements of our equity
securities. As of June 30, 2006, we had received total net
proceeds of approximately $1.9 million from private
placements of our securities. Subsequent to June 30, 2006,
we completed a private placement of our securities in which we
raised net proceeds of $3,225,140.
At June 30, 2006, we had cash and cash equivalents of
$324,154 and had a working capital deficit of $107,516.
Subsequent to June 30, 2006, we closed a private placement
in which we received net proceeds of $3,100,140 (after paying
our Chief Executive Officer $125,000 of deferred compensation
then due to him), increasing our cash and cash equivalents to
$3,424,294. We intend to use these funds for the following
purposes:
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approximately $100,000 to purchase the active pharmaceutical
ingredient required to manufacture batches of CPP-109 for use in
our U.S. Phase II clinical trial; |
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approximately $600,000 to pay a contract manufacturer for
services in connection with the development and manufacture of
our formulation of vigabatrin and to pay for required
bioequivalency studies with respect to the chemical composition
of CPP-109; |
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approximately $500,000 to support the clinical trial for cocaine
addiction in Mexico and the ongoing clinical study for cocaine
cravings in the United States; |
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approximately $500,000 to start our U.S. Phase II clinical trial; |
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approximately $650,000 to pay costs associated with this
offering; and |
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the balance for general corporate purposes. |
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Operating Capital and Capital Expenditure Requirements |
We have to date incurred operating losses, and we expect these
losses to increase substantially in the future as we expand our
product development programs and prepare for the
commercialization of CPP-109. We anticipate using a significant
portion of the proceeds from this offering to finance these
activities. It may take several years to obtain the necessary
regulatory approvals to commercialize CPP-109 in the United
States.
We believe that the net proceeds from this offering, together
with our existing cash, cash equivalents and short-term
investments, will be sufficient to meet our projected operating
requirements for the next 30 months, including our requirements
relating to obtaining necessary regulatory approvals and to the
commercialization of CPP-109 for use in treating cocaine and
methamphetamine addiction.
Our future funding requirements will depend on many factors,
including:
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the scope, rate of progress and cost of our clinical trials and
other product development activities; |
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future clinical trial results; |
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the terms and timing of any collaborative, licensing and other
arrangements that we may establish; |
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the cost and timing of regulatory approvals; |
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the cost and delays in product development as a result of any
changes in regulatory oversight applicable to our products; |
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the cost and timing of establishing sales, marketing and
distribution capabilities; |
34
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the effect of competition and market developments; |
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the cost of filing, prosecuting, defending and enforcing any
patent claims and other intellectual property rights; and |
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the extent to which we acquire or invest in other products. |
If we are unable to generate a sufficient amount of revenue to
finance our future operations, product development and
regulatory plans, we may seek to raise additional funds through
public or private equity offerings, debt financings, capital
lease transactions, corporate collaborations or other means. We
may seek to raise additional capital due to favorable market
conditions or strategic considerations even if we have
sufficient funds for planned operations. Any sale by us of
additional equity or convertible debt securities could result in
dilution to our stockholders.
To the extent that we raise additional funds through
collaborative arrangements, it may be necessary to relinquish
some rights to our technologies or grant sublicenses on terms
that are not favorable to us. We do not know whether additional
funding will be available on acceptable terms, or at all. If we
are not able to secure additional funding when needed, we may
have to delay, reduce the scope of or eliminate one or more
research and development programs or sales and marketing
initiatives.
Net cash used in operations was $434,527 and $244,111,
respectively, for the six months ended June 30, 2006 and
2005, respectively and $455,360, $230,520 and $365,784,
respectively for 2005, 2004 and 2003. Net cash used in each of
these periods primarily reflects that portion of the net loss
for these periods not attributed to non-cash compensation.
Net cash used in investing activities was $12,446 and 3,940 for
the six months ended June 30, 2006 and 2005, respectively,
and $3,940, $1,831 and $0, respectively, for 2005, 2004 and
2003. Such funds were used primarily to purchase computer
equipment.
Net cash provided by financing activities was $0 and $1,046,516
for the six months ended June 30, 2006 and 2005,
respectively, and $1,046,516, $0 and $674,957 in 2005, 2004 and
2003, respectively. Net cash from financing activities is
comprised of the net proceeds of the two private placements that
we completed in April 2003 and March 2005. Such funds were used
to fund our research and development costs and our general and
administrative costs in 2005, 2004, 2003 and during the first
half of 2006.
As of June 30, 2006, we had contractual obligations as
follows:
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Payments Due by Period | |
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Less than | |
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After 5 | |
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Total | |
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1 year | |
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1-3 years | |
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4-5 years | |
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years | |
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Debt
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$ |
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$ |
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$ |
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$ |
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$ |
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Capital leases
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Operating leases
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33,285 |
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17,736 |
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15,549 |
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Total
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$ |
33,285 |
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$ |
17,736 |
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$ |
15,549 |
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$ |
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$ |
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We intend to enter into employment agreements with two of our
executive officers, which will become effective on the closing
of this offering and will require aggregate base salary payments
of $515,000 per year following this offering.
35
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Off-Balance Sheet Arrangements |
We currently have no debt and no capital leases. We have an
operating lease for our office facility. We do not have any
off-balance sheet arrangements as such term is defined in rules
promulgated by the SEC.
Recent Accounting Pronouncements
In May 2005, the Financial Accounting Standards Board, or FASB,
issued Statement of Financial Accounting Standards No. 154,
Accounting Changes and Error Corrections a
replacement of APB Opinion No. 20 and FASB Statement
No. 3, or SFAS 154. SFAS 154 replaces APB
Opinion No. 20, Accounting Changes, and FASB
Statement No. 3, Reporting Accounting Changes in
Interim Financial Statements, and changes the requirements
relating to the accounting for and reporting of any changes in
accounting principles. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning
after December 15, 2005. SFAS 154 applies to all
voluntary changes in accounting principles. It also applies to
changes required by an accounting pronouncement in the unusual
instance that the pronouncement does not include specific
transition provisions. When a pronouncement includes specific
transition provisions, those provisions should be followed.
APB Opinion No. 20 previously required that most voluntary
changes in accounting principles be recognized by including, in
net income of the period of the change, the cumulative effect of
changing to the new accounting principle. SFAS 154 requires
retrospective application to prior periods financial
statements of changes in accounting principle, unless it is
impracticable to determine either the period-specific effects or
the cumulative effect of the change. When it is impracticable to
determine the period-specific effects of an accounting change in
one or more individual prior periods presented, SFAS 154
requires that the new accounting principle be applied to the
balances of assets and liabilities as of the beginning of the
earliest period for which retrospective application is
practicable, and that a corresponding adjustment be made to the
opening balance of retained earnings (or other appropriate
components of equity or net assets in the statement of financial
position) for that period, rather than being reported in an
income statement. When it is impracticable to determine the
cumulative effect of applying a change in accounting principle
to all prior periods, SFAS 154 requires that the new
accounting principle be applied as if it were adopted
prospectively from the earliest date practicable. We do not
believe that the adoption of SFAS 154 will have a
significant effect on our financial statements.
In March 2006, the FASB issued SFAS 156
Accounting for Servicing of Financial Assets
an amendment of FASB Statement No. 140, or
SFAS 156. SFAS 156 is effective for the first fiscal
year beginning after September 15, 2006. SFAS 156
changes the way entities account for servicing assets and
obligations associated with financial assets acquired or
disposed of. We have not yet completed our evaluation of the
impact of adopting SFAS 156 on our results of operations or
financial position, but do not expect that the adoption of
SFAS 156 will have a material impact.
Other accounting standards that have been issued or proposed by
the FASB or other standards-setting bodies that do not require
adoption until a future date are not expected to have a material
impact on our consolidated financial statements upon adoption.
Quantitative and Qualitative Disclosures About Market Risk
Market risk represents the risk of changes in the value of
market risk-sensitive instruments caused by fluctuations in
interest rates, foreign exchange rates and commodity prices.
Changes in these factors could cause fluctuations in our results
of operations and cash flows.
Our exposure to interest rate risk is currently confined to our
cash that is invested in highly liquid money market funds. The
primary objective of our investment activities is to preserve
our capital to fund operations. We also seek to maximize income
from our investments without assuming significant risk. We do
not use derivative financial instruments in our investment
portfolio. Our cash and investments policy emphasizes liquidity
and preservation of principal over other portfolio
considerations.
36
OUR BUSINESS
Overview
We are a specialty pharmaceutical company focused on the
development and commercialization of prescription drugs for the
treatment of addiction. Our initial product candidate is
CPP-109, which is based on the chemical compound
gamma-vinyl-GABA, commonly referred to as vigabatrin. We
intend to begin in the fourth quarter of 2006 a Phase II
clinical trial evaluating CPP-109 for the treatment of cocaine
addiction. We also intend to develop CPP-109 to treat
methamphetamine addiction. We believe that our CPP-109 platform
has the potential to produce therapies for other addictions,
including addictions to nicotine, prescription pain medications,
alcohol, and marijuana, as well as treatments for related
addictive disorders, such as obesity and compulsive gambling.
Many addictive drugs, including cocaine and methamphetamine,
produce feelings of euphoria by increasing the concentration of
the chemical neurotransmitter dopamine in specific areas of the
brain. Under normal conditions, dopamine levels are relatively
constant, increasing temporarily as a result of experiences such
as eating or sexual arousal. Over time, the feeling of pleasure
is decreased by a reduction in dopamine to its pre-arousal level
and through the action of gamma-aminobutyric acid, or
GABA, a chemical neurotransmitter that inhibits the effect of
dopamine. Substances such as cocaine and methamphetamine cause
enormous amounts of dopamine buildup, producing feelings of
euphoria. CPP-109 increases the amount of GABA present, which
suppresses the responses to the dramatic increase in dopamine
levels produced by cocaine and methamphetamine, thereby
preventing the perception of pleasure that is associated with
their use.
We have been granted an exclusive worldwide license from
Brookhaven National Laboratory, which we refer to as Brookhaven,
to nine U.S. patents and two U.S. patent applications relating
to the use of vigabatrin for the treatment of a wide variety of
substance addictions. The nine issued patents expire between
2018 and 2020. Additionally, we have received approval from the
European Union with respect to one of our principal patents,
which will allow us to seek approval for this patent in each of
the EU member states.
In the fourth quarter of 2006, we plan to begin an approximately
375 patient, double-blind, randomized, placebo-controlled Phase
II clinical trial in the United States to evaluate CPP-109 for
the treatment of cocaine addiction. This trial is designed to
provide potentially pivotal efficacy data, which may support the
filing of a New Drug Application, or NDA, although we cannot
assure you as to whether additional clinical trials may be
required before we are permitted to file an NDA for CPP-109. We
are also supporting a 100 patient, double-blind,
placebo-controlled clinical trial in Mexico evaluating CPP-109
for treatment of cocaine addiction. Further, we are supporting
an ongoing 10 patient, double-blind, placebo-controlled clinical
study evaluating CPP-109 for the reduction of cocaine cravings.
In addition, two open-label pilot studies were conducted in
Mexico in 2003 and 2004 by a member of our Scientific Advisory
Board. In one study, of the 30 patients enrolled, 18 completed
the study and 16 tested negative for methamphetamine and cocaine
during the last six weeks of the trial. In another study, of the
20 patients enrolled, eight completed the study and remained
drug-free for periods ranging from
46-58 days. During and
for at least six weeks following the completion of these trials,
many of the completers reported reduced cravings, beneficial
weight gain and other positive behavioral changes. These studies
strongly supported our intention to advance CPP-109 as a
potential treatment for cocaine and methamphetamine addiction.
In December 2004, the Food and Drug Administration, or FDA,
accepted our Investigational New Drug application, or IND, for
CPP-109 for the treatment of cocaine addiction. We have been
granted Fast Track status by the FDA for CPP-109, a designation
intended to facilitate the drug development and regulatory
review process. A treatment for cocaine addiction is recognized
as addressing an unmet medical need for which no pharmacological
products are currently approved for marketing. As a result, we
believe that the receipt of Fast Track status may accelerate the
regulatory approval process, although we cannot assure you that
our clinical trials will be successful or that we will obtain
approval of an NDA for CPP-109.
37
Our Business Strategy
To facilitate our business development and growth we plan to:
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Focus on CPP-109 for cocaine addiction. We intend to
commence a U.S. Phase II clinical trial for the use of CPP-109
for treating cocaine addiction. Treatment for cocaine addiction
addresses a significant unmet medical need, and we believe that
our receipt of Fast Track status may facilitate the regulatory
approval process. |
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Develop additional indications for CPP-109. The mechanism
of action of CPP-109 makes it suitable as a potential treatment
for addiction states that share the common element of heightened
dopamine levels. We plan next to develop CPP-109 for the
treatment of methamphetamine addiction. Further, our research
indicates that CPP-109 is a platform technology with the
potential to treat other conditions involving heightened
dopamine levels such as addictions to nicotine, prescription
pain medications, alcohol, marijuana, and related addictive
disorders, including obesity and compulsive gambling. |
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Acquire or license additional addiction therapies. We
know of other product candidates that may have the potential for
the treatment of addiction. We may seek to acquire or license
one or more of these product candidates to expand our
development programs. We have entered into no such agreements to
date. |
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Develop second generation of CPP-109. We plan to develop
a new formulation of CPP-109. If we are successful, we intend to
initially seek approval for this new formulation in Europe,
where we may be able to obtain exclusive marketing rights.
Subsequently, we may seek approval for this new formulation in
the United States. |
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Leverage the services of thought leaders in addiction
treatment. We believe that members of our Scientific
Advisory Board are among the most respected researchers in the
field of addiction therapy. We intend to utilize their
knowledge, services and relationships to guide our development
process and commercialization strategy. |
Industry Background Substance Abuse and
Addiction
Addiction is a worldwide health problem that affects millions of
people and has wide-ranging negative social consequences. In
2004, an estimated 19 million people in the United States
suffered from dependence on illicit drugs, according to the
National Survey on Drug Use and Health, published by the
Substance Abuse and Mental Health Services Administration, or
SAMHSA, which we refer to as the SAMHSA survey. According to the
Office of National Drug Control Policy, costs of drug abuse to
society were an estimated $180 billion in 2002 in the
United States.
Addiction is not only a U.S. health problem. For example,
according to the United Nations Office for Drug Control and
Crime Prevention, in 2004 there were approximately
3.4 million users of cocaine and 2.7 million users of
amphetamine-type stimulants across Europe. We believe that the
direct and indirect costs of cocaine and methamphetamine use are
indicative of a significant global public health problem,
representing a significant unmet medical need for which no
adequate pharmaceutical therapies exist.
Cocaine Addiction. According to the SAMHSA survey, an
estimated two million people had used cocaine in the month
preceding the survey. Additionally, in 2004 one million people
had used cocaine for the first time within the preceding
12 months, an average of approximately 2,700 new users per
day. According to the same study, approximately 884,000 patients
sought treatment for cocaine abuse in 2004. According to the
National Institute of Drug Abuse, or NIDA, there are no
pharmacologic treatments for cocaine addiction currently
approved for marketing by the FDA. We believe that other
therapies being developed for the treatment of cocaine
addiction, but not yet approved for marketing, suffer from
significant limitations which have not been exhibited to date by
CPP-109.
38
Methamphetamine Addiction. According to the SAMHSA
survey, an estimated 583,000 people had used methamphetamine in
the month preceding the survey. Additionally, an estimated
318,000 people had used methamphetamine for the first time
within the preceding 12 months, an average of 871 new users
per day. Additionally, according to the SAMHSA survey, 393,000
patients sought treatment for methamphetamine and other
stimulant abuse in 2004. A study funded by the Wal-Mart
Foundation in 2004 determined that each methamphetamine-using
employee costs his or her employer $47,500 per year due to lost
productivity, absenteeism, higher healthcare costs and higher
workers compensation costs. Similar to cocaine addiction,
there are no currently approved drugs for treatment of
methamphetamine addiction.
Nicotine Addiction. According to the SAMHSA survey, an
estimated 70.3 million people had used tobacco products in
the month preceding the survey. Further, the study reported that
in 2004 the number of people who started smoking within the
preceding 12 months was approximately 2.1 million.
According to NIDA, in 2000 approximately $80 billion in
direct healthcare costs and an estimated $58 billion in
indirect costs were attributable to smoking. According to the
National Institutes of Health, 70% of adult smokers in the
U.S. want to quit and 40% make a serious attempt to quit
each year. However, fewer than 5% succeed in any given year,
according to industry data. Global sales of smoking cessation
products were approximately $1.4 billion in 2004.
Other Addictions. According to the SAMHSA survey, in 2004
an estimated six million people took prescription drugs for
non-medical purposes, including approximately 4.4 million
who abused prescription pain relievers. Further, according to
the SAMHSA survey approximately 16.7 million people in the
United States were classified as heavy drinkers. Additionally,
according to the SAMHSA survey there are approximately
14.6 million persons who used marijuana in the month
preceding the survey and approximately one million persons
sought treatment in 2004. Finally, other addictive disorders
such as obesity and compulsive gambling have been shown to have
similar mechanisms of action to drug addiction and affect
millions of persons in the United States and around the world.
Limitations of Current Approaches to Addiction Treatment: Our
Market Opportunity
Recent scientific evidence has established that drug abuse can
interfere with the brains normal balance of
neurotransmitter release and reuptake, resulting in addiction.
If this balance is not restored, addicted individuals, even
after significant periods of abstinence, may be incapable of
suppressing cravings or quitting through willpower alone, even
with the assistance of professional counseling.
Historically, addicted individuals have been treated primarily
through behavioral modification, which has a high rate of
relapse. According to the SAMHSA survey, treatment completion
rates in 2000 for outpatient treatment were only 41% for alcohol
and 20% for cocaine. For the treatment of cocaine dependence,
there is a one-year relapse rate of 69% after 90 days or
less of outpatient treatment and 80% after 90 days or less
of long-term residential treatment. We believe that a
pharmacological treatment for cocaine addiction would complement
and significantly improve the effectiveness of counseling
programs.
Despite the significant public health implications, there are
very few therapies approved for the treatment of addiction,
either in the United States or in the rest of the world. We
believe that currently approved drugs for addiction treatment,
as well as compounds under development (other than CPP-109), are
subject to the following limitations:
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no single compound has broad applicability for treatment of
multiple addictions; |
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many of these compounds are receptor active, which
means they have drug-like effects themselves and have the
potential for abuse or addiction; |
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increasing dosages over time may be required; and |
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they are often ineffective at eliminating drug cravings or
responding to increasing levels of drug use. |
39
For example, we believe that a product candidate known as TA-CD,
which is being developed as a cocaine vaccine, would be limited
to treating only cocaine addiction and can be overwhelmed by
increasing doses of cocaine. Similarly, we believe that
baclofen, which is a type of chemical known as a
GABAB
agonist and which has been evaluated to treat cocaine addiction
but is not approved for that indication, is receptor active and
requires increasing dosing over time. Such limitations may
result in the United States Drug Enforcement Agency designating
these therapies, if they are approved, as
scheduled,subjecting them to a high level of
regulatory control as to manufacturing, distribution,
prescription and use. Neither of these compounds is approved for
marketing as a treatment for addiction in the United States, and
we believe that these limitations will significantly limit the
potential of these drugs as addiction treatments.
We believe that CPP-109 does not suffer from these limitations,
and therefore has the potential to become a widely prescribed,
safe and effective treatment for cocaine, methamphetamine and
other addictions, if approved.
Pharmacodynamics of Addictive Drugs
Addictive drugs are used recreationally because of the
transient, pleasurable effect they have on the user. These
effects are the result of biochemical changes the drug causes in
the brain.
Normal brain activity occurs through electrical signals which
are transmitted across brain cells known as neurons. Signals are
transmitted from neuron to neuron across a small gap, known as
the synaptic cleft, by the release of chemical messengers known
as neurotransmitters. The releasing, or pre-synaptic, neuron
sends a neurotransmitter into the synaptic cleft to the
receiving, or post-synaptic, neuron, which has specialized
receptor molecules that pick up the neurotransmitter, triggering
the post-synaptic neuron to initiate its own release. The
repetition of this process from neuron to neuron, along what are
known as the mesolimbic pathways, is responsible for the
transport of signals in the brain. Once the neurotransmitter has
stimulated the receptor, it is either broken down or reabsorbed
into the pre-synaptic neuron.
Almost all drugs of abuse affect the pathway for the
neurotransmitter known as dopamine. Dopamine is associated with
the pleasure system of the brain, causing feelings of enjoyment
in order to motivate certain behaviors, such as eating or sexual
function. Dopamine is a naturally produced chemical that binds
to dopamine-specific receptors on the neuron. Under normal
conditions, only a portion of the brains dopamine
receptors are occupied at any one time. After dopamine is
released from the receptor, the pre-synaptic neuron reuptakes
dopamine using a protein that is a dopamine reuptake
transporter, and the dopamine is subsequently stored or broken
down by an enzyme called monamine oxidase, or MAO. Drugs that
block the natural reuptake or breakdown of dopamine result in
elevated levels of dopamine in the synaptic cleft, triggering
feelings of pleasure and euphoria.
Over time, the feeling of euphoria fades due to the natural
reduction in dopamine and through the action of GABA, or
Gamma-aminobutyric acid, which is an inhibitory neurotransmitter
found in the brain. GABA, in turn, is broken down by a chemical
called GABA transaminase, or GABA-T. Under normal conditions,
dopamine effects are moderated by GABA, which in turn is
moderated by GABA-T, maintaining the brain in a balanced,
pre-arousal state.
Mechanism of Action of Cocaine. Cocaine binds to the
dopamine reuptake transporter protein of the pre-synaptic
neurons preventing the reuptake and eventual breakdown of
dopamine, resulting in enhanced and prolonged stimulation of
dopamine on post-synaptic receptors, causing a feeling of
prolonged euphoria for the user.
Addiction to cocaine is caused by a neurological process called
desensitization. Because the brain senses an unnaturally high
level of dopamine, it responds by reducing the amount of
dopamine released and the number of dopamine receptors created.
Consequently, when the cocaine wears off, the user has a
lower amount of dopamine and fewer functioning dopamine
receptors, which results in a depressed mood. This
desensitization
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process creates a lowering of mood each time the user takes more
of the drug, causing the user to seek additional cocaine to
restore normal feelings, and requiring the user to take an
increasing amount of cocaine to achieve the same feeling of
euphoria as before.
Mechanism of Action of Methamphetamine. Methamphetamine
is chemically similar to dopamine and another neurotransmitter
called norepinephrine. Due to its chemical structure,
methamphetamine is carried into the pre-synaptic neuron and
triggers the release of dopamine and norepinephrine into the
synaptic cleft. Methamphetamine also reverses the action of the
transporter molecules that normally cause dopamine or
norepinephrine reuptake from the synaptic cleft back into the
neuron, resulting in a flood of dopamine back into the synaptic
cleft. In addition, methamphetamine blocks the enzymes that
cause the breakdown of these neurotransmitters. The resulting
elevated levels of dopamine trigger feelings of euphoria and
pleasure, and excess norepinephrine may be responsible for the
alertness and anti-fatigue effects associated with the drug.
Similar to cocaines mechanism of addiction,
methamphetamine users undergo the desensitization process,
resulting in increasing usage to achieve the same effects.
Mechanism of Action of Nicotine. Nicotine has a similar
chemical structure to the neurotransmitter acetylcholine.
Acetylcholine and its receptors are involved in many activities,
including respiration, maintenance of heart rate, memory,
alertness, and muscle movement. Once nicotine enters the brain,
it activates receptors that normally respond to acetylcholine,
called cholinergic receptors. Regular use of nicotine causes a
decrease in the number of cholinergic receptors and a decrease
in the sensitivity of these receptors to nicotine and
acetylcholine. Recent research has also shown that nicotine
causes an increased release of dopamine resulting in the
pleasurable sensation triggered by its use. We believe that the
increase in dopamine levels is similar, although less intense,
than that observed in cocaine and methamphetamine users.
Our Platform Technology
Mechanism of Action of CPP-109. We believe that our
product candidate, CPP-109, will be an effective addiction
treatment because it eliminates the perception of pleasure and
reward associated with the use of dopamine-enhancing drugs.
Addictive drugs have been shown to block or overwhelm mechanisms
involved in the removal of dopamine from synaptic clefts in the
mesolimbic pathways of the brain, resulting in highly elevated
levels of dopamine available to stimulate receptors and a
dramatically heightened sense of pleasure or reward. However,
dopamine is associated with other actions beyond the mediation
of those responses. Simply blocking dopamine effects at the
receptor site is ineffective and associated with profound side
effects, such as the extensive impairment of motor functions
seen in patients with Parkinsons disease. Therefore, more
sophisticated approaches to regulating the specific actions of
dopamine are required.
GABA, the most abundant inhibitory neurotransmitter in the
brain, balances the brain by inhibiting over-excitation. When
GABA binds to a GABA receptor, it inhibits the post-synaptic
neuron from triggering the release of neurotransmitters,
preventing the subsequent firing of an electrical signal. GABA
helps induce relaxation and sleep, and contributes to functions
such as motor control and vision. An enzyme known as GABA-T is
responsible for the eventual breakdown of GABA once the feeling
of euphoria has faded.
Vigabatrin is a GABA analog that inhibits GABA-T. The drug is
readily absorbed and promptly available to the central nervous
system, producing effects that last for many hours after a
single dose. Therefore, administration of vigabatrin results in
significantly elevated GABA levels. This prevents the perception
of pleasure and reward resulting from dramatic increases in
dopamine levels caused by cocaine and methamphetamine use.
Vigabatrin administration does not appear to affect the baseline
levels of dopamine, nor those variations in dopamine levels
caused by normal stimuli.
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History and Side Effect Profile. Vigabatrin has been
marketed over the past decade in over 30 countries by
Sanofi-Aventis under the brand name Sabril as a secondary
treatment for adult epilepsy and as a primary treatment for the
management of infantile spasms, known as West Syndrome. The
composition of matter patents for Sabril expired in 1993.
Neither vigabatrin nor Sabril has been approved in the United
States for any indication.
In chronic use for the treatment of epilepsy, vigabatrin has
been generally well tolerated. The most common side effects
reported have been drowsiness and fatigue. However, one clearly
established adverse side effect is the development, with
increasing cumulative dosage levels of vigabatrin approaching
1,500 grams, of peripheral visual field defects, or VFDs, in
approximately 33% of users. These VFDs are manifest as a
constriction of the peripheral field of vision, or the loss of
visual acuity at the extreme left and right edges of the field
of vision. While the exact cause of these VFDs is unknown, they
are believed to be irreversible, with the resultant requirement
that recipients of vigabatrin for epilepsy must receive regular
six month visual tests while using the drug.
Prior research has indicated that VFDs occur at doses far higher
than the dosage amount we anticipate will be used for addiction
treatment. However, we have not completed the testing necessary
to determine whether this is the case.
Brookhavens Research. Our initial interest in
vigabatrin was based on Brookhavens research with it
regarding the pathology and treatment of cocaine and other
addictions. Brookhaven scientists have shown that the dopamine
pathway responds similarly to drugs of abuse. In 1997,
scientists at Brookhaven harnessed an emerging technology,
positron emission tomography scans, or PET scans, and became the
first to image the effects of addicting substances in living
human subjects. Through the use of PET scans, Brookhaven
scientists were able to show that as the number of engaged
dopamine receptors in the brain increased, so too did the
high, or euphoric feeling, of the user.
Platform Technology. We believe that vigabatrin is
potentially suitable for the treatment of many addictions due to
its ability to block the euphoria associated with heightened
levels of dopamine. These include our initial focus areas of
cocaine and methamphetamine addictions and addictions to other
substances including nicotine, prescription pain medications,
alcohol and marijuana, as well as related addictive disorders
such as obesity and compulsive gambling. Brookhaven has licensed
to us patents relating to the use of CPP-109 as a treatment for
all abused drugs. Consequently, if CPP-109 is determined to be a
safe and effective treatment for cocaine and methamphetamine
addiction, we may pursue additional clinical trials to determine
whether CPP-109 can be used to treat addiction to other
substances.
Our Clinical Research
In 2004 the FDA accepted our IND for CPP-109 for the treatment
of cocaine addiction. We have been granted Fast Track status for
CPP-109 from the FDA. Under the Federal Food, Drug and Cosmetic
Act, or FFDCA, the FDA is directed to facilitate the development
and expedite review of drugs and biologics intended to treat
serious or life-threatening conditions and that demonstrate the
potential to address unmet medical needs. Fast Track designation
emphasizes communication between us and the FDA and affords us
benefits that may help to expedite the approval process. For
example, Fast Track designation affords us the opportunity to
submit an NDA for CPP-109 on a rolling, or modular, basis,
allowing the FDA to review sections of the NDA in advance of
receiving our full submission. The designation also means that
we may have increased communications with the FDA regarding the
design of our clinical studies, which we hope will expedite the
development and review of our application for the approval of
CPP-109 and provide greater certainty overall in the regulatory
pathway.
Planned Phase II Clinical Trial for Cocaine
Addiction United States. We intend to begin a
Phase II clinical trial in the fourth quarter of 2006 to
evaluate CPP-109 for the treatment of cocaine addiction. Our
protocol design specifies a double-blind, randomized,
placebo-controlled trial involving approximately 375
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patients at multiple treatment sites in the United States and
Canada. To be eligible to participate in the trial, participants
must meet specific clinical standards for cocaine dependence, as
specified in DSM-IV, a set of diagnosis guidelines established
for clinical professionals. Additionally, trial participants
cannot meet the DSM-IV criteria for dependence on other
addictive substances. The trial is expected to be 26 weeks in
duration, with subjects divided into three equal groups. One
group will receive vigabatrin for a 26-week period. A second
group will receive vigabatrin for a nine-week period, followed
by a placebo for 17 weeks. The third group will receive a
placebo for the full 26 weeks. The primary endpoint of this
study is three weeks of abstinence from cocaine at nine weeks
and again at 26 weeks. A secondary endpoint measures
abstinence for three-week periods at 18 weeks and a
reduction in cocaine use from baseline at 18 weeks.
Further, eye safety studies will be conducted on all trial
participants to determine the extent of any VFDs among such
participants.
Clinical Trial for Cocaine Addiction Mexico.
We are supporting a clinical trial evaluating CPP-109 for the
treatment of cocaine addiction. We have received approval from
Mexican authorities to begin enrollment for this trial, which we
expect to begin in the third quarter of 2006. The principal
investigators of this trial are Dr. Jonathan Brodie, Ph.D.,
M.D., a professor of Psychiatry at New York University and a
member of our Scientific Advisory Board, and Dr. Emilia
Figueroa, M.D., a physician addiction specialist who directs
several addiction treatment clinics in Mexico. Dr. Brodie
designed the protocol for this trial, a double-blind,
randomized, placebo-controlled trial involving 100 patients at a
single location in Mexico City. Subjects will be selected from a
pool of cocaine-dependent prison parolees who meet the specific
clinical standards for cocaine dependence, as specified in
DSM-IV, with a history of cocaine usage. The trial is expected
to continue for one year. The primary endpoint of the trial is
patient abstinence from cocaine for a period of 21 days
following treatment. In addition to the primary endpoints, eye
safety studies will be conducted to determine the extent of any
visual field defects among the trial participants. We are
providing research funding for this trial as well as a supply of
vigabatrin for the duration of the trial. We are also paying for
the eye studies required to determine whether the use of
vigabatrin in treating addiction causes VFDs.
Ongoing Clinical Study for Cocaine Craving United
States. We are currently supporting a clinical study to
evaluate the effects of CPP-109 on cocaine cravings, which are
strongly associated with relapse of addiction. This trial, the
protocol for which was designed by Dr. Margaret Haney,
Ph.D., a member of the faculty of Columbia University, is a
double-blind, randomized, placebo-controlled trial involving 10
patients at a single location in the United States. Subjects are
required to meet DSM-IV criteria for cocaine dependence.
Enrollment began in April 2006 and the trial is scheduled to
last for 57 days, with primary endpoints of level of
cocaine craving, as measured by a craving scale index, and serum
concentrations of cocaine in the blood. In addition to these
endpoints, eye safety studies are being conducted to determine
the extent of any visual field defects in the study participants.
If the data from these clinical trials are compelling, we may
file an NDA and seek regulatory approval in the U.S. to
commercialize CPP-109. However, a U.S. Phase III clinical
trial may be required before we are permitted to file an NDA and
seek regulatory approval for sale of CPP-109 in the United
States. There can be no assurance as to if and when we will
obtain approval of an NDA to market CPP-109.
Pilot Studies
Our intention to advance CPP-109 as a potential treatment for
cocaine and methamphetamine addiction is based on the following
studies:
Cocaine and Methamphetamine Pilot Study 2004
Mexico. The second human study of vigabatrin for addiction
was conducted in Mexico between November 2003 and January 2004
under Dr. Brodies supervision and with our financial
support. This was an open-label, nine-week study involving 30
subjects dependent on methamphetamine and/or cocaine. The study
evaluated the efficacy of vigabatrin for treatment of cocaine
and methamphetamine abuse and examined whether short-term usage
of vigabatrin caused peripheral visual field defects. Subjects
received an escalating dosage of up to 3 grams of vigabatrin per
day; patients who completed
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the study each received a total of 137 grams of vigabatrin. Of
the 30 patients who enrolled, 18 completed the study. Of these,
16 tested negative for methamphetamine and cocaine during the
last six weeks of the trial. In addition, at the beginning of
the study, none of the study completers were employed. At
completion, 16 were regularly employed, and many had been
reunited with their families. No subject who completed the study
developed any type of VFD.
Cocaine Pilot Study 2003 Mexico. The first
human study of vigabatrin for cocaine addiction was conducted in
Mexico in 2003 under Dr. Brodies supervision. This
was an open-label, nine-week study, involving 20 subjects who
had a history of drug abuse that spanned over at least a decade
and who met the clinical criteria for cocaine addiction.
Subjects received an escalating dosage regimen of up to 4 grams
of vigabatrin per day. At the completion of the study, eight out
of 20 subjects had completed the dosing regimen and remained
drug-free for periods ranging from 46-58 days. The completing
patients reported that their craving for cocaine was eliminated
within two to three weeks after administration of vigabatrin.
Additionally, many of the subjects who completed the study
experienced beneficial weight gain, reunited with their families
and manifested other positive behavioral changes.
Nicotine Animal Studies. Members of our Scientific
Advisory Board working at Brookhaven have conducted preclinical
studies using primates to evaluate the effects of vigabatrin on
nicotine addiction. In these studies, the administration of
vigabatrin inhibited the ability of nicotine to increase
dopamine levels in varying degrees based on dosage level and
time elapsed since administration of vigabatrin. When vigabatrin
was administered 12 or 24 hours prior to the introduction
of nicotine, researchers observed no increase in dopamine
levels. Based upon these findings, we intend to commence
clinical studies evaluating CPP-109 as a treatment for nicotine
addiction in 2008.
Our Competitive Strengths
We believe that the key strengths that distinguish us from our
competitors include:
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CPP-109, if approved, will offer potentially significant
advantages over current treatments for drug addiction. As set
forth below, relapse rates for traditional counseling treatments
are very high, while clinical studies of vigabatrin to date have
shown low relapse rates among the 26 patients who completed
treatment. There can be no assurance, however, that the relapse
rates over wider studies or in general use will remain as low. |
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If approved, we believe that the use of CPP-109 in conjunction
with counseling will potentially offer a more efficacious and
cost-effective addiction treatment than is currently available. |
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Unlike other compounds, we believe that CPP-109 has no abuse
liability; that is, we believe that CPP-109 does not substitute
addiction to one drug for addiction to another drug. As a
result, we believe it will be easier for patients to cease using
CPP-109 after treatment without withdrawal effects. |
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CPP-109s mechanism of action potentially allows it to be
used to treat most types of substance addiction and abuse. |
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We have been granted Fast Track status for CPP-109 by the FDA,
which allows us an expedited review process with the FDA of any
NDA we may file for CPP-109. |
Competition
The biotechnology and pharmaceutical industries are highly
competitive. In particular, competition for the development and
marketing of therapies to treat addictive substances such as
cocaine, methamphetamine, and nicotine is intense and expected
to increase. Many of our competitors have substantially greater
financial and other resources, larger research and development
staffs and more experience developing products, obtaining FDA
and other regulatory approval of products and manufacturing and
marketing products. We compete
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against pharmaceutical companies that are developing or
currently marketing therapies for addictive substances. In
addition, we compete against biotechnology companies,
universities, government agencies, and other research
institutions in the development of substance abuse treatments,
technologies and processes that are, or in the future may be,
the basis for competitive commercial products. While we believe
that our product candidates will offer advantages over many of
the currently available competing therapies, our business could
be negatively impacted if our competitors present or
future offerings are more effective, safer or less expensive
than ours, or more readily accepted by regulators, healthcare
providers or third-party payors.
While there are no currently approved therapies for cocaine or
methamphetamine addiction, we are aware of other therapies under
development. These can be broadly classified into three groups:
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Cocaine-mimetics. The mechanism of action of these drugs
is similar to cocaine. None of these approaches have, to our
knowledge, shown any efficacy. These compounds include: |
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methylphenidate, which is marketed as Ritalin by Novartis, and |
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GBR-12909, which is known as vanoxerine and is currently in
Phase II clinical trials sponsored by the National Institute of
Drug Abuse. |
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Cocaine-antagonists. These compounds are intended to
selectively target GABA, moderating dopamine levels in the
brain. We believe that many of these compounds are receptor
active and require increasing dosing over time. None of these
compounds are presently approved for marketing to treat
addiction. These compounds include: |
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baclofen, marketed as Lioresal by Novartis, |
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topiramate, marketed as Topamax by Ortho-McNeil Neurologics, |
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tiagabine, marketed as Gabitril by Cephalon, |
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gabapentin, marketed as Neurontin by Pfizer, and |
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progabide, marketed as Gabrene by Sanofi-Aventis. |
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Addiction Vaccines. These vaccines are designed to block
cocaine transport into the brain. They do not address issues
relating to craving or other behaviors associated with cocaine
addiction. We also believe that they can be overwhelmed by
increasing dosages of cocaine. These compounds include: |
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TA-CD is a cocaine vaccine currently in Phase II clinical trials
sponsored by Celtic Pharma Development U.K. Plc. |
In addition to these therapies, we are aware that InterveXion
Therapeutics LLC is developing two monoclonal antibody based
compounds for treatment of methamphetamine and phencyclidine, or
PCP, addictions.
Finally, Ovation Pharmaceuticals, Inc., which holds the North
American rights to Sabril as an adjunctive therapy for the
treatment of epilepsy and as a primary treatment for West
Syndrome, has indicated its intent to undertake studies with
respect to the use of Sabril in treating cocaine addiction. We
believe that any commercialization by Ovation of Sabril for this
use would violate our licensed patents, and we would assert any
such rights if Ovation sought to market Sabril for the treatment
of cocaine addiction. There can be no assurance we would be
successful in that regard.
Most therapies to treat nicotine addiction can be classified
into two groups, nicotine replacement therapies and
prescription-only neurotransmitter modulators. Numerous
over-the-counter, or OTC, therapies currently exist to treat
nicotine addiction such as transdermal nicotine patches,
inhalation sprays, nicotine gum, lozenges and oral dose drugs.
Although there are a wide variety of OTC products for nicotine
addiction, the only
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currently marketed prescription product specific to smoking
cessation is Zyban, marketed by GlaxoSmithKline plc.
Patents and Intellectual Property Rights
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Brookhaven license agreement |
We have been granted an exclusive, worldwide license from
Brookhaven Science Associates, as operator of Brookhaven
National Laboratory under contract with the United States
Department of Energy (which we refer to as Brookhaven), to nine
patents and two patent applications relating to the use of
vigabatrin for the treatment of a wide variety of substance
addictions, with expiration dates for the issued patents
occurring between 2018 and 2020. Additionally, we recently
received approval from the European Union with respect to one of
our principal patents, which will allow us to seek approval for
this patent in each of the EU member states.
The license agreement, which is dated as of April 30, 2006
and which supercedes a previous license agreement that was
entered into in 2002, grants us an exclusive worldwide license,
including the right to sublicense, to make, have made, use,
and/or sell licensed products and practice the licensed process
with respect to the medical application in humans of vigabatrin
under certain patent rights. These rights are subject to the
United States governments rights to practice the licensed
process for its own use. The purpose of this agreement is to
permit us to commercialize products upon the receipt of
government regulatory approval for the use of vigabatrin for the
treatment of human drug addiction and addiction-related
behavior. In exchange for such rights, we have agreed to pay
Brookhaven a fee of $100,000 in the year of NDA approval for
CPP-109, $250,000 in each of the second and third years
following approval, and $500,000 per year until the last patent
expires. In addition, we have agreed to reimburse Brookhaven for
all reasonable and customary expenses it incurs from the
beginning of our agreement in connection with the filing,
prosecution and maintenance of all patents and patent
applications included in the patent rights we have licensed.
We have also agreed to consult with Brookhaven not less
frequently than quarterly with respect to drug development steps
taken and progress made toward the objective of gaining
marketing approval from the FDA for any licensed product from
the beginning of our agreement through the date the FDA grants
us its approval to sell any licensed product. We have also
agreed to have in effect and maintain a liability insurance
policy in an amount of at least $1,000,000 to cover claims
arising out of the manufacture and use of licensed products and
such policy shall designate Brookhaven as an additional insured.
We have agreed to increase and maintain, throughout the life of
the agreement and for five years after its termination,
liability insurance coverage in the amount of at least
$5,000,000 upon acceptance by the FDA of our application to
commence Phase III clinical trials involving licensed products.
Our agreement with Brookhaven expires simultaneously with the
expiration of the last to expire patent it has licensed to us.
Protection of our intellectual property and proprietary
technology is a strategic priority for our business. We rely on
a combination of patent, trademark, copyright and trade secret
laws along with institutional know-how and continuing
technological advancement to develop and maintain our
competitive position. Our ability to protect and use our
intellectual property rights in the continued development and
commercialization of our technologies and products, operate
without infringing the proprietary rights of others, and prevent
others from infringing our proprietary rights, is crucial to our
continued success. We will be able to protect our products and
technologies from unauthorized use by third parties only to the
extent that they are covered by valid and enforceable patents,
trademarks or copyrights, or are effectively maintained as trade
secrets, know-how or other proprietary information.
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Manufacturing, Marketing and Reimbursement
Since the composition of matter patent for vigabatrin has
expired, we are free to manufacture CPP-109, subject to the
receipt of necessary regulatory approvals. We have an agreement
with a qualified manufacturer of the active pharmaceutical
ingredient used in vigabatrin to supply our current
requirements. We also have an agreement with a contract
manufacturer to formulate and manufacture CPP-109 for use in our
upcoming clinical trials and thereafter, to manufacture
commercial quantities of CPP-109. In the event that sufficient
quantities of CPP-109 are not available for our upcoming trials,
we intend to use the branded version of vigabatrin and
subsequently demonstrate the bioequivalence of CPP-109 to the
branded version of vigabatrin.
We do not currently have any in-house marketing, distribution,
or production capabilities. In order to generate sales of
CPP-109 or any other product candidates we may develop, we must
either acquire or develop an internal marketing force with
technical expertise and with supporting documentation
capabilities, or make arrangements with third parties to perform
these services for us. The acquisition and development of a
marketing and distribution infrastructure will require
substantial resources, which may divert the attention of our
management and key personnel away from our product development
efforts. To the extent that we enter into marketing and
distribution arrangements with third parties, our revenues will
depend on the efforts of others. If we fail to enter into such
agreements, or if we fail to develop our own marketing and
distribution channels, we would experience delays in product
sales and incur increased costs.
Government Regulation
Governmental authorities in the United States and other
countries extensively regulate the testing, manufacturing,
labeling, storage, record-keeping, advertising, promotion,
export, marketing and distribution, among other things, of
pharmaceutical products. In the United States, the FDA, under
the FFDCA, and other federal statutes and regulations, subjects
pharmaceutical products to review. If we do not comply with
applicable requirements, we may be fined, the government may
refuse to approve our marketing applications or allow us to
manufacture or market our products, our products may be seized
and we may be criminally prosecuted.
FDA Approval Process. To obtain approval of a new product
from the FDA, we must, among other requirements, submit data
supporting safety and efficacy as well as detailed information
on the manufacture and composition of the product and proposed
labeling. The testing and collection of data and the preparation
of necessary applications are expensive and time-consuming. The
FDA may not act quickly or favorably in reviewing these
applications, and we may encounter significant difficulties or
costs in our efforts to obtain FDA approvals that could delay or
preclude us from marketing our products.
The process required by the FDA before a new drug may be
marketed in the United States generally involves the following:
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completion of non-clinical laboratory and animal testing in
compliance with FDA regulations; |
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submission of an investigational new drug application, or IND,
which must become effective before human clinical trials may
begin; |
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performance of adequate and well-controlled human clinical
trials to establish the safety and efficacy of the proposed drug
for its intended use; and |
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submission and approval of an NDA by the FDA. |
The sponsor typically conducts human clinical trials in three
sequential phases, but the phases may overlap. In Phase I
clinical trials, the product is tested in a small number of
patients or healthy volunteers, primarily for safety at one or
more dosages. In Phase II clinical trials, in addition to
safety, the sponsor evaluates the efficacy of the product on
targeted indications, and identifies possible adverse effects
and safety risks in a
47
patient population. Phase III clinical trials typically involve
testing for safety and clinical efficacy in an expanded
population at geographically-dispersed test sites. The FDA
closely monitors the progress of each phase of clinical testing
and may, at its discretion, reevaluate, alter, suspend or
terminate testing based on the data accumulated to that point
and its assessment of the risk/benefit ratio to the patient.
Total time required for carrying out such clinical testing
varies between two and ten years. Additional clinical testing is
often required for special classes of patients, e.g., such as
the elderly, or those with kidney impairment, and to test for
infections with other drugs. Based on the known side effects of
VFDs associated with vigabatrin when used in the treatment of
epilepsy, our clinical studies will also seek to determine if
VFDs are associated with vigabatrin when dispensed in the
dosages and for the limited periods proposed for the treatment
of cocaine and methamphetamine addiction.
Clinical trials must be conducted in accordance with the
FDAs good clinical practices requirements. The FDA may
order the partial, temporary or permanent discontinuation of a
clinical trial at any time or impose other sanctions if it
believes that the clinical trial is not being conducted in
accordance with FDA requirements or presents an unacceptable
risk to the clinical trial patients. The institutional review
board, or IRB of each clinical site, generally must approve the
clinical trial design and patient informed consent at that site
and may also require the clinical trial at that site to be
halted, either temporarily or permanently, for failure to comply
with the IRBs requirements, or may impose other conditions.
The applicant must submit to the FDA the results of the
non-clinical and clinical trials, together with, among other
things, detailed information on the manufacture and composition
of the product and proposed labeling, in the form of an NDA,
including payment of a user fee. The FDA reviews all NDAs
submitted before it accepts them for filing and may request
additional information rather than accepting an NDA for filing.
Once the submission is accepted for filing, the FDA begins an
in-depth review of the NDA. Under the policies agreed to by the
FDA under the Prescription Drug User Fee Act, or PDUFA, the FDA
has 10 months in which to complete its initial review of a
standard NDA and respond to the applicant, and six months
to complete its initial review of a priority NDA. The priority
review process and the PDUFA goal date may be extended by three
months if the FDA requests or the NDA sponsor otherwise provides
additional information or clarification regarding information
already provided in the submission within the last three months
of the PDUFA goal date. If the FDAs evaluations of the NDA
and the clinical and manufacturing procedures and facilities are
favorable, the FDA may issue either an approval letter or an
approvable letter, which contains the conditions that must be
met in order to secure final approval of the NDA. If and when
those conditions have been met to the FDAs satisfaction,
the FDA will issue an approval letter, authorizing commercial
marketing of the drug for certain indications. If the FDAs
evaluation of the NDA submission and the clinical and
manufacturing procedures and facilities is not favorable, the
FDA may refuse to approve the NDA and issue a not approvable
letter.
Section 505(b)(1) New Drug Applications. The
approval process described above is premised on the applicant
being the owner of, or having obtained a right of reference to,
all of the data required to prove the safety and effectiveness
of a drug product. This type of marketing application, sometimes
referred to as a full or stand-alone
NDA, is governed by Section 505(b)(1) of the FFDCA. A
Section 505(b)(1) NDA contains full reports of
investigations of safety and effectiveness, which includes the
results of preclinical studies and clinical trials, together
with detailed information on the manufacture and composition of
the product, in addition to other information. We may submit a
Section 505(b)(1) application for CPP-109.
Section 505(b)(2) New Drug Applications. As an
alternate path to FDA approval for new indications, improved
formulations of previously-approved products, or new chemical
entities, a company may submit a Section 505(b)(2) NDA,
instead of a stand-alone or full NDA
filing under Section 505(b)(1) as described above.
Section 505(b)(2) of the FFDCA was enacted as part of the
Drug Price Competition and Patent Term Restoration Act of 1984,
otherwise known as the Hatch-Waxman Amendments.
Section 505(b)(2) permits the submission of an NDA where at
least some of the information required for approval comes from
studies not conducted by or for the applicant and for which the
applicant has not obtained a right of reference. For example,
the Hatch-Waxman Amendments permit the applicant to rely upon
the FDAs findings of safety and
48
effectiveness for an approved product, or on published
literature reports, or both. The FDA may also require companies
to perform additional studies or measurements to support
approval. We may submit a Section 505(b)(2) application for
CPP-109. This application may rely, in part, on published study
reports for which we do not have a right of reference.
To the extent that a Section 505(b)(2) applicant is relying
on the FDAs findings for an already-approved product, the
applicant is required to certify to the FDA concerning any
patents listed for the approved product in the FDAs Orange
Book publication, which is the FDAs list of approved drug
products and the indications for which they are approved.
Specifically, the applicant must certify that: (1) the
required patent information has not been filed; (2) the
listed patent has expired; (3) the listed patent has not
expired, but will expire on a particular date and approval is
sought after patent expiration; or (4) the listed patent is
invalid or will not be infringed by the manufacture, use or sale
of the new product. A certification that the new product will
not infringe the already approved products Orange
Book-listed patents or that such patents are invalid is called a
paragraph IV certification. If the applicant does not
challenge the listed patents, the Section 505(b)(2)
application will not be approved until all the listed patents
claiming the referenced product have expired. The
Section 505(b)(2) application may also not be approved
until any non-patent exclusivity, such as exclusivity for
obtaining approval of a new chemical entity, listed in the
Orange Book for the referenced product has expired.
If the applicant has provided a paragraph IV certification
to the FDA, the applicant must also send a notice of the
paragraph IV certification to the NDA and the holder of the
underlying patent once the NDA has been accepted for filing by
the FDA. The NDA and patent holders may then initiate a legal
challenge to the paragraph IV certification. The filing of
a patent infringement lawsuit within 45 days of their
receipt of a paragraph IV certification automatically
prevents the FDA from approving the Section 505(b)(2) NDA
until the earliest of 30 months, expiration of the patent,
settlement of the lawsuit or a decision in the infringement case
that is favorable to the Section 505(b)(2) applicant. For
drugs with five-year exclusivity, if an action for patent
infringement is initiated after year four of that exclusivity
period, then the 30-month stay period is extended by such amount
of time so that 7.5 years has elapsed since the approval of
the NDA with five-year exclusivity. This period could be
extended by six months if the NDA sponsor obtains pediatric
exclusivity. Alternatively, if the listed patent holder does not
file a patent infringement lawsuit within the required 45-day
period, the applicants NDA will not be subject to the
30-month stay. Vigabatrin has not yet been approved by the FDA
for the treatment of addiction, Ovation has indicated its intent
to pursue development of Sabril, its branded version of
vigabatrin, for treatment of cocaine addiction. As such, at this
time we do not anticipate submitting a paragraph IV
certification. However, other applicants submitting 505(b)(2)
applications for vigabatrin that rely on CPP-109, if approved,
as well as an applicant that submits an abbreviated new drug
application, or ANDA, that cites CPP-109 as the reference listed
drug, would be required to submit patent certifications for any
patents listed in the Orange Book for CPP-109.
Notwithstanding the approval of many products by the FDA
pursuant to Section 505(b)(2), over the last few years,
certain brand-name pharmaceutical companies and others have
objected to the FDAs interpretation of
Section 505(b)(2). If these companies successfully
challenge the FDAs interpretation of
Section 505(b)(2), the FDA may be required to change its
interpretation of Section 505(b)(2). This could delay or
even prevent the FDA from approving any Section 505(b)(2)
NDA that we submit.
The Hatch-Waxman Act. Under the Hatch-Waxman Amendments,
newly-approved drugs and indications benefit from a statutory
period of non-patent marketing exclusivity. The Hatch-Waxman
Amendments provide five-year marketing exclusivity to the first
applicant to gain approval of an NDA for a chemical entity,
meaning that the FDA has not previously approved any other drug
containing the same active ingredients. The Hatch-Waxman
Amendments prohibit the submission of an ANDA, or a
Section 505(b)(2) NDA for another version of such drug
during the five-year exclusive period; however, as explained
above, submission of an ANDA or Section 505(b)(2) NDA
containing a paragraph IV certification is permitted after
four years, which may trigger a 30-month stay of approval of the
ANDA or Section 505(b)(2) NDA. Protection under
Hatch-Waxman will not prevent the submission or approval of
another full or stand-alone NDA;
however, the
49
applicant would be required to conduct its own non-clinical and
adequate and well-controlled clinical trials to demonstrate
safety and effectiveness. The Hatch-Waxman Amendments also
provide three years of marketing exclusivity for the approval of
new and supplemental NDAs, including Section 505(b)(2)
NDAs, for, among other things, new indications, dosages, or
strengths of an existing drug, if new clinical investigations
that were conducted or sponsored by the applicant are essential
to the approval of the application.
If the FDA approves another companys version of vigabatrin
before it approves CPP-109, and awards that company five-year
marketing exclusivity, then we could not submit a 505(b)(2)
application for CPP-109 for at least four years. If, however, we
submit a full or stand-alone NDA for
CPP-109 under Section 505(b)(1) of the FDCA, then any
competitors five-year marketing exclusivity will not block
approval of CPP-109.
In addition to non-patent marketing exclusivity, the
Hatch-Waxman Amendments amended the FFDCA to require each NDA
sponsor to submit with its application information on any patent
that claims the drug for which the applicant submitted the NDA
or that claims a method of using such drug and with respect to
which a claim of patent infringement could reasonably be
asserted if a person not licensed by the owner engaged in the
manufacture, use, or sale of the drug. Generic applicants that
wish to rely on the approval of a drug listed in the Orange Book
must certify to each listed patent, as discussed above. We
intend to submit for Orange Book listing all relevant patents
for our product candidate.
Finally, the Hatch-Waxman Amendments amended the patent laws so
that certain patents related to products regulated by the FDA
are eligible for a patent term extension if patent life was lost
during a period when the product was undergoing regulatory
review, and if certain criteria are met. We intend to seek
patent term extensions, provided our patents and products, if
they are approved, meet applicable eligibility requirements.
Fast Track Designation. The FDAs Fast Track program
is intended to facilitate the development and to expedite the
review of drugs that are intended for the treatment of a serious
or life-threatening condition and that demonstrate the potential
to address unmet medical needs. Under the Fast Track program,
applicants may seek traditional approval for a product based on
data demonstrating an effect on a clinically meaningful
endpoint, or approval based on a well-established surrogate
endpoint. The sponsor of a new drug candidate may request the
FDA to designate the drug candidate for a specific indication as
a Fast Track drug at the time of original submission of its IND,
or at any time thereafter prior to receiving marketing approval
of a marketing application. The FDA has granted fast track
status to CPP-109.
Fast track designation permits the FDA to initiate review of
sections of an NDA before the application is complete. This
so-called rolling review is available if the
applicant provides and the FDA approves a schedule for the
submission of the remaining information and the applicant has
paid applicable user fees. The FDAs PDUFA review clock for
both a standard and priority NDA for a fast track product does
not begin until the complete application is submitted.
Additionally, fast track designation may be withdrawn by the FDA
if it believes that the designation is no longer supported by
emerging data, or if the designated drug development program is
no longer being pursued. A product approved under the FDAs
Fast Track program is subject to expedited withdrawal of
approval if required post-approval studies are not conducted
with due diligence, if the studies fail to verify the clinical
benefit of the product, or if the sponsor disseminates false or
misleading materials with respect to the product.
Other Regulatory Requirements. We may also be subject to
a number of post-approval regulatory requirements. If we seek to
make certain changes to an approved product, such as promoting
or labeling a product for a new indication, making certain
manufacturing changes or product enhancements or adding labeling
claims, we will need FDA review and approval of an NDA
supplement before the change can be implemented. While
physicians may use products for indications that have not been
approved by the FDA, we may not label or promote the product for
an indication that has not been approved. Securing FDA approval
for new indications or product enhancements and, in some cases,
for manufacturing and labeling claims, is generally a
time-consuming and expensive process that may require us to
conduct clinical trials under the FDAs IND
50
regulations. Even if such studies are conducted, the FDA may not
approve any change in a timely fashion, or at all. In addition,
adverse experiences associated with use of the products must be
reported to the FDA, and FDA rules govern how we can label,
advertise or otherwise commercialize our products.
There are current post-marketing safety surveillance
requirements that we will need to meet to continue to market an
approved product. The FDA also may, in its discretion, require
post-marketing testing and surveillance to monitor the effects
of approved products or place conditions on any approvals that
could restrict the commercial applications of these products.
In addition to FDA restrictions on marketing of pharmaceutical
products, several other types of state and federal laws have
been applied to restrict certain marketing practices in the
pharmaceutical industry in recent years. These laws include
anti-kickback statutes and false claims statutes. The federal
health care program anti-kickback statute prohibits, among other
things, knowingly and willfully offering, paying, soliciting or
receiving remuneration to induce or in return for purchasing,
leasing, ordering or arranging for the purchase, lease or order
of any health care item or service reimbursable under Medicare,
Medicaid or other federally financed health care programs. This
statute has been interpreted to apply to arrangements between
pharmaceutical manufacturers on the one hand and prescribers,
purchasers and formulary managers on the other. Violations of
the anti-kickback statute are punishable by imprisonment,
criminal fines, civil monetary penalties and exclusion from
participation in federal health care programs. Although there
are a number of statutory exemptions and regulatory safe harbors
protecting certain common activities from prosecution or other
regulatory sanctions, the exemptions and safe harbors are drawn
narrowly, and practices that involve remuneration intended to
induce prescribing, purchases or recommendations may be subject
to scrutiny if they do not qualify for an exemption or safe
harbor.
Federal false claims laws prohibit any person from knowingly
presenting, or causing to be presented, a false claim for
payment to the federal government, or knowingly making, or
causing to be made, a false statement to have a false claim
paid. Recently, several pharmaceutical and other health care
companies have been prosecuted under these laws for allegedly
inflating drug prices they report to pricing services, which in
turn are used by the government to set Medicare and Medicaid
reimbursement rates, and for allegedly providing free product to
customers with the expectation that the customers would bill
federal programs for the product. In addition, certain marketing
practices, including off-label promotion, may also violate false
claims laws. The majority of states also have statutes or
regulations similar to the federal anti-kickback law and false
claims laws, which apply to items and services reimbursed under
Medicaid and other state programs, or, in several states, apply
regardless of the payor.
In addition, we and the manufacturers on which we rely for the
manufacture of our products are subject to requirements that
drugs be manufactured, packaged and labeled in conformity with
current good manufacturing practice, or cGMP. To comply with
cGMP requirements, manufacturers must continue to spend time,
money and effort to meet requirements relating to personnel,
facilities, equipment, production and process, labeling and
packaging, quality control, record-keeping and other
requirements. The FDA periodically inspects drug manufacturing
facilities to evaluate compliance with cGMP requirements.
Also, as part of the sales and marketing process, pharmaceutical
companies frequently provide samples of approved drugs to
physicians. This practice is regulated by the FDA and other
governmental authorities, including, in particular, requirements
concerning record-keeping and control procedures.
Any marketing of CPP-109 outside of the United States will be
contingent on receiving approval from the various regulatory
authorities. Foreign regulatory systems, although they vary from
country to country, include risks similar to those associated
with FDA regulation in the United States. Under the European
Union regulatory system, applications for drug approval may be
submitted either in a centralized or decentralized manner. Under
the centralized procedure, a single application to the European
Medicines Agency leads to an
51
approval granted by the European Commission which permits
marketing of the product throughout the European Union. The
decentralized procedure provides for mutual recognition of
nationally approved decisions and is used for products that do
not comply with requirements for the centralized procedure.
Under the decentralized procedure, the holders of national
marketing authorization in one of the countries within the
European Union may submit further applications to other
countries within the European Union, who will be requested to
recognize the original authorization based on an assessment
report provided by the country in which marketing authorization
is held.
As with FDA approval, we may not be able to secure regulatory
approvals in certain European countries in a timely manner, if
at all. Additionally, as in the U.S., post-approval regulatory
requirements would apply to any products that is approved in
Europe, and failure to comply with such obligations could have a
material adverse effect on our ability to successfully
commercialize any product.
Outside of the European Union, we are subject to widely varying
foreign obligations, which may be quite different from those of
the FDA, governing clinical studies, product registration and
approval and pharmaceutical sales. Whether or not FDA approval
has been received, we must obtain separate approval for products
by the comparable regulatory authorities of foreign countries
prior to the commencement of marketing CPP-109 in those
countries. The approval process varies from country to country,
and the time may be longer or shorter than that required for FDA
approval. In addition, under current U.S. law, there are
significant restrictions on the export of products not approved
by the FDA, depending on the country involved and the status of
the product in that country.
Our Employees
We currently employ four persons, including our Chief Financial
Officer, who is currently a consultant but will be an employee
upon completion of this offering. We also utilize the services
of consultants, including members of our board of directors and
Scientific Advisory Board. None of our employees are covered by
a collective bargaining agreement. We believe our relationship
with our employees and consultants is good.
Our Scientific Advisory Board
We rely on prominent scientists and physicians to advise us on
our pipeline of drug candidates and the clinical development of
CPP-109. All of our advisors are employed by organizations other
than us and may have commitments to or consulting or advisory
agreements with other entities that may limit their availability
to us. Our Scientific Advisory Board currently consists of the
following members:
Stephen L. Dewey, Ph.D. serves as Chairman of our
Scientific Advisory Board. Dr. Dewey is a Senior Chemist at
Brookhaven National Laboratory. Dr. Dewey is a recognized
authority in positron emission tomography, which uses certain
compounds to visualize and quantitate biochemical processes as
well as the distribution and movement of drugs in the living
human and animal body. Dr. Dewey has been with Brookhaven
since 1986, serving as Assistant Chemist, Associate Chemist,
Chemist, Tenured Scientist and Senior Chemist. Dr. Dewey is
also a Research Professor of Psychiatry at the New York
University School of Medicine and an Adjunct Professor of
Neurobiology and Behavior at SUNY at Stony Brook. Dr. Dewey
has been developing a novel approach to treating addiction
within Brookhavens PET program and is devoted to research
within this area. Dr. Dewey is a co-inventor of
Brookhavens patents for substance addiction, including
Brookhavens patents for vigabatrin to treat addiction.
Jonathan Brodie, Ph.D., M.D. is the Marvin Stern
Professor of Psychiatry at New York University School of
Medicine. Dr. Brodie completed his B.S. in Chemistry as a
Ford Foundation Scholar and his Ph.D. in Physiological Chemistry
(Organic Chemistry minor) at the University of
Wisconsin-Madison. He was an NIH postdoctoral Fellow in
Biochemistry at Scripps Clinic and Research Foundation and a
tenured associate professor of Biochemistry at the School of
Medicine at SUNY at Buffalo. He then received his M.D. at New
York University School of Medicine and joined the faculty after
completing his residency in psychiatry at
52
NYU/ Bellevue Medical Center. He is a member of the Promotions
and Tenure Committee of the School of Medicine as well as a
member of the Executive Advisory Committee of the General
Clinical Research Center and the Protocol Review Committee of
the Center for Advanced Brain Imaging (CABI) of Nathan Kline
Institute. For 15 years, he was the NYU Director of the
Brookhaven National Laboratory/ NYUSOM collaboration
investigating the use of positron emitters and PET in
neuroscience and psychiatry. Additionally, Dr. Brodie
serves as a psychopharmacology instructor to psychiatry
residents. As a clinician, he treats patients in general issues
of adult psychiatry including anxiety and depression.
Dr. Brodie is a co-inventor of Brookhavens patents
for substance addiction, including Brookhavens patents for
vigabatrin to treat addiction.
Donald R. Jasinski, M.D. is Chief of the Center for
Chemical Dependence at Johns Hopkins Bayview Medical Center in
Baltimore, Maryland. Dr. Jasinski received his medical
degree from the University of Illinois School of Medicine. After
receiving his degree, Dr. Jasinski worked at the
U.S. Public Health Service at the Addiction Research Center
in Kentucky, which was the first national laboratory set up to
deal with narcotics and their effects. Dr. Jasinski has
pioneered the use of buprenorphine to treat opioid dependence.
Buprenorphine, which was developed as a pain reliever for cancer
patients, is now seen by many in the medical community as the
best drug on the market to treat patients who are addicted to
heroin. Dr. Jasinski has agreed to be our principal
investigator for our U.S. Phase II Study.
Robert D. Fechtner, M.D. is Professor of Ophthalmology
and Director, Glaucoma Division at the Institute of
Ophthalmology and Visual Science UMDNJ New Jersey
Medical School, Newark, New Jersey. Dr. Fechtner received
his B.S. in Biomedical Science and his medical degree from the
University of Michigan School of Medicine. He completed his
residency at Albert Einstein College of Medicine in New York.
This was followed by a fellowship in glaucoma at the University
of California, San Diego under a National Research Service Award
from the National Institutes of Health. After several years on
the faculty at University of Louisville, he and his family
returned home to New Jersey where he joined the faculty at New
Jersey Medical School. Dr. Fechtner has published over 70
articles and chapters and is on the editorial boards of American
Journal of Ophthalmology and Journal of Glaucoma.
Eugene Laska, Ph.D. is Professor of Psychiatry at the
Department of Psychiatry at New York University Medical Center.
Dr. Laska received a Ph.D. in Mathematics at New York
University, and then completed a PHS Postdoctoral Fellowship at
the Department of Statistics at Stanford University.
Dr. Laska is the Director of the Statistical Sciences and
Epidemiology Division of the Nathan Kline Institute for
Psychiatric Research. Dr. Laska is also the Director of the
WHO Collaborating Center for Research and Training in Mental
Health Program Management, and has served as a consultant to
large and small pharmaceutical companies in the areas of
biostatistics and clinical trial design.
Facilities
We currently operate our business in leased office space in
Coral Gables, Florida. We pay annual rent on our office space of
approximately $17,900. In anticipation of the expansion of our
operations, we plan to obtain additional leased space in the
near future.
Legal Proceedings
We are not a party to any legal proceedings.
53
OUR MANAGEMENT
Officers and Directors
The following table shows information about our officers and
directors as of the date of this prospectus:
|
|
|
|
|
Name |
|
Age |
|
Position(s) |
|
|
|
|
|
Patrick J. McEnany |
|
59 |
|
Co-Founder, Chairman, President and Chief Executive Officer |
Hubert E. Huckel,
M.D.(1)
|
|
75 |
|
Co-Founder and Director |
Charles B.
OKeeffe(2)(3)
|
|
66 |
|
Senior Advisor and Director |
Philip H.
Coelho(2)(3)
|
|
62 |
|
Director |
David S. Tierney,
M.D.(1)(3)
|
|
43 |
|
Director |
Milton J.
Wallace(1)(3)
|
|
70 |
|
Director |
Jack Weinstein
|
|
50 |
|
Vice President, Treasurer and Chief Financial Officer |
M. Douglas Winship
|
|
57 |
|
Vice President of Regulatory Operations |
|
|
(1) |
Member of the Audit Committee. |
|
(2) |
Member of the Compensation Committee. |
|
(3) |
Member of the Nominating and Corporate Governance Committee. |
Patrick J. McEnany is our Co-Founder, Chairman, President
and Chief Executive Officer. Mr. McEnany has been Chief
Executive Officer and a director since our formation in January
2002. He became Chairman and President in April 2006. From 1999
through 2002, Mr. McEnany was President of AMDG, Inc., a
developer of pharmaceutical products From 1991 to 1997,
Mr. McEnany was Chairman and Chief Executive Officer of
Royce Laboratories, Inc., a generic pharmaceutical manufacturer.
From 1997 to 1998, after the merger of Royce into Watson
Pharmaceuticals, Inc., Mr. McEnany served as president of
the wholly-owned Royce Laboratories subsidiary and vice
president of corporate development for Watson Pharmaceuticals,
Inc. From 1993 to 1997, he also served as vice chairman and a
director of the National Association of Pharmaceutical
Manufacturers. He currently serves on the board of directors for
ThermoGenesis Corp., Renal CarePartners, Inc. and the Jackson
Memorial Hospital Foundation. Mr. McEnany also served on
the board of directors of Med/Waste, Inc. from 2000 until 2002,
when that company filed for voluntary bankruptcy protection
under federal bankruptcy laws.
Hubert E. Huckel, M.D. is our Co-Founder and is a member
of our board of directors. Dr. Huckel was Chairman of the
Board until April 2006. Dr. Huckel spent 29 years with
The Hoechst Group (now part of Sanofi-Aventis), and was at the
time of his retirement in 1992, executive chairman of the board
of Hoechst-Roussel Pharmaceuticals, Inc. Dr. Huckel has
continued his involvement in the prescription drug industry and
currently serves on the boards of directors of Titan
Pharmaceuticals, Inc., ThermoGenesis Corp., Valera
Pharmaceuticals, Inc., and Concordia Pharmaceuticals, Inc.
Dr. Huckel received his M.D. degree from the University of
Vienna, Austria and is a member of the Rockefeller University
Council.
Charles B. OKeeffe became a consultant to us in
December 2004 and has served as our Senior Adviser since that
time. Mr. OKeeffe has also served as a member of our
board of directors since December 2004. Mr. OKeeffe
is a Professor in the Department of Epidemiology and Community
Health at Virginia Commonwealth University, and has served in
such capacity since January 1, 2004. Mr. OKeeffe
joined VCU after retiring as President and chief executive
officer of Reckitt Benckiser Pharmaceuticals, Inc., a position
Mr. OKeeffe held from 1991 until 2003. As President
of Drug Abuse Rehabilitation Services (from 1970 until 1971), he
developed the first child-resistant, abuse-resistant vehicle for
dispensing methadone. He served as president of Washington
Reference Laboratories from 1972 until 1975, which provided
toxicology services to the Department of Defense during the
Vietnam War. He has served in the White House (from 1970 until
1973 and
54
from 1976 until 1980) for three presidents as
advisor, special assistant for international health and deputy
director for international affairs in the Office of Drug Abuse
Policy and has served on U.S. delegations to
the World Health Assembly and the U.N. Commission on Narcotic
Drugs. Mr. OKeeffe played a significant role in
helping Congress reach consensus on the Drug Addiction Treatment
Act of 2000.
Philip H. Coelho has been a member of our board of
directors since October 2002. Mr. Coelho has been employed
with ThermoGenesis Corp., a company focused on the blood
processing and hospital/woundcare markets, since October 1986.
Since November 1997, Mr. Coelho has served as chairman and
chief executive officer of ThermoGenesis; from December 1989 to
November 1997, Mr. Coelho was president and chief executive
officer of ThermoGenesis; and from October 1986 to September
1989, Mr. Coelho served as vice president and director of
research and development of ThermoGenesis. Prior to this, from
October 1983 to October 1986, Mr. Coelho was president of
Castleton, Inc., a company that developed and licensed the
ultra-rapid heat transfer technology to ThermoGenesis.
Mr. Coelho holds a Bachelor of Science degree in Mechanical
Engineering from the University of California, Davis.
David S. Tierney, M.D. has served as a member of our
board of directors in October 2002. Dr. Tierney has served
as the president and chief executive officer, and has served as
a director of, Valera Pharmaceuticals, Inc. a specialty
pharmaceutical company, since 2000. From January 2000 to August
2000, Dr. Tierney served as President of Biovail
Technologies, a division of Biovail Corporation, a Canadian drug
delivery company, where he was responsible for all of
Biovails research and development, regulatory and clinical
activities. From March 1997 to January 2000, Dr. Tierney
was Senior Vice President of Drug Development at Roberts
Pharmaceutical Corporation, where he was responsible for all
research and development activities, and for drug development,
medical affairs, worldwide regulatory affairs and chemical
process development, as well as being part of the executive
management team. From December 1989 to March 1997,
Dr. Tierney was employed by Élan Corporation, a
pharmaceutical company, in a variety of management positions.
Dr. Tierney received his medical degree from the Royal
College of Surgeons in Dublin, Ireland and was subsequently
trained in internal medicine.
Milton J. Wallace became a member of our board of
directors in October 2002. Mr. Wallace was a practicing
attorney in Miami, Florida for over 40 years until 2005,
when he retired. Mr. Wallace served as co-founder and
chairman of Renex Corporation, a provider of kidney dialysis
services, from July 1993 to February 2000, when that company was
acquired by National Nephrology Associates, Inc.
Mr. Wallace also was the co-founder and a director of Home
Intensive Care, Inc., a provider of home infusion and dialysis
services, from 1985 to July 1993, when that company was acquired
by W.R. Grace & Co. Mr. Wallace was chairman of the
board of directors of Med/Waste, Inc., an entity engaged in the
business of medical waste, from June 1993 until
February 13, 2002, when that company filed a voluntary
bankruptcy petition under federal bankruptcy laws.
Mr. Wallace currently serves as chairman of the board of
directors of Renal CarePartners, Inc. and as a member of the
board of directors of Imperial Industries, Inc.
Jack Weinstein has served as a consultant to us and as
our Chief Financial Officer since October 2004. For the last
20 years Mr. Weinstein has primarily been employed as
an investment banker with various firms. From 2002 to 2004,
Mr. Weinstein was with, and he currently is a licensed
agent of, The Avalon Group, Ltd., a broker-dealer. From 1999 to
2002, Mr. Weinstein was employed by Ladenburg Thalmann
& Co., Inc. From 1994 to 1999, Mr. Weinstein was
employed by Gruntal & Co., LLC. Mr. Weinstein earned a
Bachelors Degree from the University of Miami in 1979 and a
Masters in Business Administration from Harvard University
Graduate School of Business Administration in 1983.
M. Douglas Winship joined us in July 2006 as our Vice
President of Regulatory Operations. Mr. Winship has worked
in regulatory affairs in the healthcare industry for
30 years. From 2004 to 2005, Mr. Winship was vice
president quality assurance and regulatory affairs
for Argos Theraputics, Inc., a biotechnology company developing
immuno therapy treatments for cancer, in Durham, North Carolina.
Previously, Mr. Winship was employed by CEL-SCI Corp., a
biotechnology company developing immune system based treatments,
in Vienna, VA, from 1998 to 2002 as senior vice
president regulatory affairs and
55
quality assurance, and from 1994 through 1998 as vice
president regulatory affairs and quality assurance.
From 1998 to 1994, Mr. Winship was employed by Curative
Technologies, Inc., a health-care company involved in the
wound-healing market, first as director of regulatory affairs
and quality assurance and later as vice president of Regulatory
Affairs and Quality Assurance. Mr. Winship earned his
Bachelor of Science in chemistry from Upsala College in 1971.
Board Composition
Our board of directors consists of six directors, each serving a
one-year term expiring at the next annual meeting of
stockholders. The board will satisfy all criteria for
independence established by the Nasdaq Global Market, or Nasdaq,
and other governing laws and regulations. No director will be
deemed to be independent unless the board affirmatively
determines that the director has no material relationship with
us directly, or as an officer, stockholder or partner of an
organization that has a relationship with us.
Board Committees
Upon the completion of this offering, the standing committees of
our board of directors will consist of the Audit Committee,
Compensation Committee and Nominating and Corporate Governance
Committee. These committees are described below. Our board of
directors may also establish various other committees to assist
it in its responsibilities.
Audit Committee
The Audit Committee is primarily concerned with the accuracy and
effectiveness of the audits of our financial statements by our
independent auditors. Its duties include:
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selecting independent auditors; |
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|
|
reviewing the scope of the audit to be conducted by them and the
results of their audit; |
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|
|
approving non-audit services provided to us by the independent
auditor; |
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|
|
reviewing the integrity, adequacy and effectiveness of our
financial reporting process and internal controls; assessing our
financial reporting practices, including the disclosures in our
annual and quarterly reports and the accounting standards and
principles followed; and |
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conducting other reviews relating to compliance by our employees
with our policies and applicable laws. |
Currently, the Audit Committee is comprised of
Messrs. Wallace, Huckel and Tierney, each of whom is
independent as defined under Nasdaq rules. Mr. Wallace
currently serves as Chairman of the committee. The board of
directors has determined that Mr. Wallace qualifies as
audit committee financial expert as that term is
defined under the rules of the Securities and Exchange
Commission, or SEC.
Compensation Committee
This Compensation Committees primary responsibility is to
discharge our board of directors responsibilities relating
to compensation of our senior executives. Its duties include:
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developing guidelines and reviewing the compensation and
performance of our executive officers; |
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setting the compensation of the chief executive officer and
evaluating his performance based on corporate goals and
objectives; |
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making recommendations to the board of directors with respect to
incentive compensation plans, equity-based plans and deferred
compensation plans; and |
56
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reviewing director compensation levels and practices, and
recommending, from time to time, changes in such compensation
levels and practices to the board of directors. |
Currently, the Compensation Committee is comprised of
Messrs. OKeeffe and Coelho, each of whom is
independent as defined under Nasdaq rules.
Nominating and Corporate Governance Committee
The Nominating and Corporate Governance Committees
responsibilities include the selection of potential candidates
for our board of directors and the development and annual review
of our governance principles. This committee also annually
reviews director compensation and benefits, and oversees the
annual self-evaluations of our board of directors and its
committees. It also makes recommendations to our board of
directors concerning the structure and membership of the other
board committees.
The Nominating and Corporate Governance Committee is comprised
of all of our outside directors, each of whom is independent as
defined under Nasdaq rules.
Compensation Committee Interlocks and Insider
Participation
None of the members of our Compensation Committee were at any
time an officer or employee of ours. In addition, none of our
executive officers serves as a member of the board of directors
or compensation committee of any entity that has one or more
executive officers serving as a member of our board of directors
or Compensation Committee, except that Mr. McEnany serves
on the compensation committee of ThermoGenesis, the Chief
Executive Officer of which is Mr. Coelho.
Compensation of Directors
Our directors currently do not receive, and have not received,
any cash compensation for serving on our board. Directors are
eligible to receive stock options and restricted share grants of
our common stock under our 2006 Stock Incentive Plan. No options
or restricted shares have been granted to our directors to date.
Executive Compensation
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Current and historic compensation paid to executives and
consultants |
Prior to 2005, Mr. McEnany received no compensation for
serving as our Chief Executive Officer. In January 2005, we
entered into an employment agreement with Mr. McEnany under
which he was to receive an annual salary of $100,000 per annum.
However, Mr. McEnany agreed to defer 50% of his annual
salary until such time as we procured financing and raised gross
proceeds of at least $2.0 million; Mr. McEnany
subsequently agreed to defer 100% of his compensation until such
financing was obtained. In that regard, Mr. McEnany was
paid all deferred compensation, aggregating $125,000, from the
proceeds of our recently completed private placement. We intend
to enter into a new employment agreement with Mr. McEnany
which shall become effective upon the completion of this
offering.
In October 2004, we entered into a consulting agreement with
Mr. Weinstein. Under the terms of the consulting agreement,
as amended, Mr. Weinstein receives a monthly consulting fee
of $7,500. In addition, Mr. Weinstein will receive a fee in
the amount of approximately $150,000 from the proceeds of this
offering. See Certain Relationships and Related
Transactions. We intend to enter into an employment
agreement with Mr. Weinstein which will become effective
upon the completion of this offering.
In January 2005, we entered into a consulting agreement with
Mr. OKeeffe under which we pay him a monthly
consulting fee of $5,000, payable $2,500 in cash and $2,500 in
shares of our common stock valued at $2.00 per share. We also
pay consulting fees to several members of our scientific
advisory board, as follows: Dr. Dewey ($1,500 per month),
Dr. Jasinski ($1,500 per month), and Dr. Brodie
($1,000 per month).
57
Mr. Winship is paid a base salary of $180,000 per annum for
serving as our Vice President of Regulatory Affairs. He also
will have the opportunity to earn bonuses of up to 20% of his
base salary by meeting performance objectives approved by the
Compensation Committee of the Board.
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Post-offering compensation for Messrs. McEnany and
Weinstein |
We intend to enter into employment agreements with
Messrs. McEnany and Weinstein which shall become effective
upon completion of this offering. Under these agreements,
Messrs. McEnany and Weinstein will receive base salaries of
$315,000 and $200,000, respectively, and bonus compensation
based on performance. Each employment agreement will also
contain a change of control severance arrangement if
the employee is not retained in our employment after a change of
control.
Stock Options and Stock Incentive Plans
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Currently outstanding stock options |
In each of July 2002 and March 2005, we issued options to
purchase 250,000 shares of our common stock to each of
Mr. McEnany and Dr. Huckel (options to purchase
1,000,000 shares in the aggregate). These options are currently
vested, expire ten years after their grant dates, and have an
exercise price of $1.00 per share.
In 2004 and 2005, we issued options to purchase shares of our
common stock to Messrs. Weinstein and OKeeffe.
Mr. OKeeffe holds options to purchase 200,000 shares
of our common stock at an exercise price of $2.00 per share.
Mr. OKeeffes options expire in January 2010.
Mr. Weinstein holds options to purchase 300,000 shares of
our common stock, 200,000 of which are at an exercise price of
$2.00 per share (100,000 expire in October 2009 and 100,000
expire in March 2010) and 100,000 of which are at an exercise
price of $4.35 per share (50,000 expire in October 2009 and
50,000 expire in March 2010). All of the options held by Messrs.
Weinstein and OKeeffe are fully vested.
In July 2006, we issued five-year options to purchase 100,000
shares of our common stock to Mr. Winship. These options
will vest over a four-year period and have an exercise price of
$4.35 per share.
The following table sets forth the number and value of
securities underlying unexercised options held by our named
executive officers at December 31, 2005. Because there was
no public market for our common stock as of December 31,
2005, amounts described in the following table under the heading
Value of Unexercised In-the-Money Options at
December 31, 2005 are determined by multiplying the
number of shares issued or issuable upon exercise of the option
by the difference between the assumed initial public offering
price of
$ per
share, which is the midpoint of the range set forth on the cover
and the per share option exercise price. In 2005, none of our
named executive officers exercised any options.
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Number of | |
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Value of Unexercised | |
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Unexercised Options at | |
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In-the-money Options at | |
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December 31, 2005 | |
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December 31, 2005 ($)(1) | |
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Exercisable | |
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Unexercisable | |
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Exercisable | |
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Unexercisable | |
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Patrick J. McEnany
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500,000 |
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Jack Weinstein
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200,000 |
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100,000 |
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(1) |
Based upon an assumed initial public offering price of
$ per
share, which is the midpoint of the range set forth on the cover
of this prospectus. |
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The 2006 Stock Incentive Plan |
Overview. Our board of directors has recently approved
the 2006 Stock Incentive Plan (the 2006 plan), and
we anticipate that our stockholders will approve the 2006 plan
prior to this offering. We have
58
reserved 1,500,000 shares for issuance under the 2006 plan. No
grants or awards have been made to date under the 2006 plan. The
purpose of the 2006 plan is to continue to advance our interests
by allowing us to attract, retain, reward, and motivate
individuals eligible under the 2006 plan to strive for our
continued success by giving them additional opportunities to
purchase further equity stakes in our company.
Administration. The Compensation Committee of our board
of directors will administer the 2006 plan and will determine
which persons will receive grants of awards and the type of
award to be granted to such persons. The Compensation Committee
will also interpret the provisions of the 2006 plan and make all
other determinations that it deems necessary or advisable for
the administration of the 2006 plan.
Eligibility. All eligible individuals will be able to
participate in the 2006 plan. Eligible individuals include our
directors, officers, employees, independent contractors and
consultants, as well as individuals who have accepted an offer
of employment with us.
Transferability of awards. Awards are non-transferable
other than by will or by the laws of descent and distribution or
as otherwise expressly allowed by the Compensation Committee
pursuant to a gift to members of an eligible persons
immediate family. The gift may be directly or indirectly
transferred, by means of a trust, partnership, or otherwise.
Stock options and SARs may be exercised only by the optionee,
any such permitted transferee or a guardian, legal
representative or beneficiary.
Change of control. If there is a change in control of
Catalyst Pharmaceutical Partners, Inc., any award that is not
exercisable and vested may immediately become exercisable and
vested in the sole and absolute discretion of the Compensation
Committee. Vested awards will be deemed earned and payable in
full. The Compensation Committee may also terminate the awards,
entitling participants to a cash payment. If we are liquidated
or dissolved, awards may also be converted into the right to
receive liquidation proceeds. In the event that the Compensation
Committee does not terminate or convert an award upon a change
of control, then the award will be assumed, or substantially
equivalent awards will be substituted, by the acquiring or
succeeding corporation.
Amendments, modifications and termination. Our board of
directors may, at any time, amend, suspend or terminate the 2006
plan, but the board may not impair the rights of holders of
outstanding awards without the holders consent. No
amendment to the 2006 plan may be made without consent of our
stockholders. In the event that an award is granted to a person
residing outside of the United States, the board may, at its
discretion, modify the terms of the agreement to comply with the
laws of the country of which the eligible individual is a
resident. The 2006 plan will terminate 10 years after its
effective date.
59
OUR PRINCIPAL STOCKHOLDERS
The following table sets forth information regarding the
beneficial ownership of our common stock as of the date of this
prospectus by:
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each person or entity who we know beneficially owns more than 5%
of our outstanding common stock; |
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each of our directors and executive officers; and |
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all directors and executive officers as a group. |
Beneficial ownership is determined in accordance with the rules
of the U.S. Securities and Exchange Commission and includes
voting or investment power with respect to the shares. In
computing the number of shares beneficially owned by a person
and the percentage ownership of that person, shares of common
stock subject to options or warrants held by that person that
are currently exercisable or will become exercisable within
60 days of the date of this prospectus are deemed
outstanding and included in the number of shares beneficially
owned, while those shares are not deemed outstanding for
purposes of computing percentage ownership of any other person.
Except as otherwise indicated, the persons named in the table
have sole voting and investment power with respect to all shares
of common stock held by them.
Applicable percentage ownership in this table is based on
6,281,900 shares of common stock outstanding as of the date of
this prospectus
and shares
of common stock outstanding immediately after the completion of
this offering. The address for each shareholder listed in the
table is c/o Catalyst Pharmaceutical Partners, Inc., 220 Miracle
Mile, Suite 234, Coral Gables, Florida 33134.
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Percentage Owned | |
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Shares Owned | |
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After Offering | |
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Patrick J.
McEnany(1)(2)
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2,706,750 |
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39.9% |
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Hubert Huckel,
M.D.(2)
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1,287,500 |
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19.0% |
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Jonathan Brodie
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315,000 |
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5.0% |
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Philip H. Coelho
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150,000 |
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2.4% |
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Charles B.
OKeeffe(3)
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222,500 |
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3.4% |
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David S. Tierney, M.D.
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125,000 |
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2.0% |
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Milton J.
Wallace(5)
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215,000 |
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3.4% |
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Jack
Weinstein(4)
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300,000 |
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4.6% |
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M. Douglas
Winship(6)
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Officers & directors as a group (8 persons)
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5,006,750 |
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64.3% |
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(1) |
Includes 100,000 shares owned by Mr. McEnanys wife. |
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(2) |
Includes options to purchase 500,000 shares of our common stock
at a price of $1.00 per share. |
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(3) |
Includes options to purchase 200,000 shares of our common stock
at a price of $2.00 per share. |
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(4) |
Includes options to purchase 300,000 shares of our common stock,
of which options to purchase 200,000 shares are exercisable at a
price of $2.00 per share and options to purchase 100,000 shares
are exercisable a price of $4.35 per share. |
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(5) |
Includes 20,000 shares owned by Biscayne National Corp.
Mr. Wallace is the president of Biscayne National Corp. |
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(6) |
Excludes options to purchase 100,000 shares of our common stock
exercisable at a price of $4.35 per share, none of which have
vested or will vest within 60 days of the date of this
prospectus. |
60
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Effective May 2006, we amended our consulting agreement with
Jack Weinstein, our Chief Financial Officer. Pursuant to the
consulting agreement, as amended, Mr. Weinstein receives a
monthly consulting fee of $7,500. As part of
Mr. Weinsteins consulting arrangement with us, he
also received five-year options to purchase an aggregate of
300,000 shares of our common stock, all of which are currently
exercisable. Options to purchase 200,000 shares of our common
stock have an exercise price of $2.00 per share, and options to
purchase 100,000 shares of our common stock have an exercise
price of $4.35 per share.
In addition, Mr. Weinstein will receive a success fee of
approximately $150,000 upon the completion of this offering.
Pursuant to the agreement, $2,500 of the monthly consulting fees
payable to Mr. Weinstein after April 30, 2006 are
being applied towards this fee. The May 2006 consulting
agreement amended the previous agreement dated October 2004
pursuant to which Mr. Weinstein received a monthly
consulting fee of $5,000, in addition to the stock options
described above.
61
DESCRIPTION OF OUR CAPITAL STOCK
Our authorized capital currently consists of 100,000,000 shares
of common stock, par value $.001 per share, and 5,000,000 shares
of preferred stock, par value $.001 per share. As of the date of
this prospectus, we had 6,281,900 shares of common stock
outstanding, of which 4,817,500 are issued shares of our common
stock and 1,464,400 are shares of our common stock issuable upon
the automatic conversion at the closing of this offering of our
Series A and B Preferred Stock. At this date, 70,000 shares
of our Series A Preferred Stock and 7,544 shares of our
Series B Preferred Stock are outstanding. All share and per
share information contained in this prospectus assumes
conversion of the currently outstanding Series A Preferred
Stock and Series B Preferred Stock into common stock at the
closing of this offering.
We were incorporated in July 2006. Our predecessor, Catalyst
Pharmaceutical Partners, Inc., a Florida corporation, was
incorporated in the State of Florida in January 2002. Prior to
the completion of this offering, we will succeed, by merger, to
all of the assets, liabilities, rights and operations of our
predecessor. All information in this prospectus about us assumes
completion of the reincorporation.
The description below of our capital stock reflects information
about Catalyst Pharmaceutical Partners, Inc., a Delaware
corporation. Such information is a summary and is qualified in
its entirety by our Certificate of Incorporation and our
By-laws. Copies of our Certificate of Incorporation and By-laws
are filed as exhibits to our registration statement, of which
this prospectus forms a part.
Common Stock
Each holder of common stock is entitled to one vote for each
share held of record on all matters presented to our
stockholders, including the election of directors. In the event
of our liquidation, dissolution, or winding-up, the holders of
common stock are entitled to share ratably and equally in our
assets, if any, that remain after paying all debts and
liabilities and the liquidation preferences of any outstanding
preferred stock. The common stock has no preemptive or
cumulative rights and no redemption or conversion provisions.
Holders of our common stock are entitled to receive dividends
if, as, and when declared by our board of directors out of funds
legally available therefor, subject to the dividend and
liquidation rights of any preferred stock that may be issued and
outstanding, all subject to any dividend restrictions in our
credit facilities. No dividend or other distribution (including
redemptions and repurchases of shares of capital stock) may be
made, if after giving effect to such distribution, we would not
be able to pay our debts as they come due in the usual course of
business, or if our total assets would be less than the sum of
our total liabilities plus the amount that would be needed at
the time of a liquidation to satisfy the preferential rights of
any holders of preferred stock.
Preferred Stock
Our board of directors is authorized, without further
stockholder action, to divide any or all shares of the
authorized preferred stock into series and fix and determine the
designations, preferences and relative rights and
qualifications, limitations, or restrictions thereon of any
series so established, including voting powers, dividend rights,
liquidation preferences, redemption rights and conversion
privileges.
Any further issuances of preferred stock with voting rights or
conversion rights may adversely affect the voting power of
common stock, including the loss of voting control to others.
The issuance of preferred stock may have the effect of delaying,
deferring, or preventing a change of control.
Provisions of the Certificate and the By-laws
A number of provisions of our certificate of incorporation and
by-laws concern matters of corporate governance and the rights
of stockholders. Certain of these provisions, as well as the
ability of our board of directors to issue shares of preferred
stock and to set the voting rights, preferences and other terms
thereof, may be deemed to have an anti-takeover effect and may
discourage takeover attempts not first approved by the board
62
of directors (including takeovers which certain stockholders may
deem to be in their best interests). To the extent takeover
attempts are discouraged, temporary fluctuations in the market
price of the common stock, which may result from actual or
rumored takeover attempts, may be inhibited. These provisions,
together with the classified board of directors (which we are
proposing to declassify) and the ability of the board to issue
preferred stock without further stockholder action, also could
delay or frustrate the removal of incumbent directors or the
assumption of control by stockholders, even if such removal or
assumption would be beneficial to our stockholders. These
provisions also could discourage or make more difficult a
merger, tender offer or proxy contests, even if they could be
favorable to the interests of stockholders, and could
potentially depress the market price of the common stock. The
board of directors believes that these provisions are
appropriate to protect the interest of us and all of our
stockholders.
Issuance of Rights. The certificate authorized the board
of directors to create and issue rights (the rights)
entitling the holders thereof to purchase from us shares of
capital stock or other securities. The times at which, and the
terms upon which, the rights are to be issued may be determined
by the board of directors and set forth in the contracts or
instruments that evidence the rights. The authority of the board
of directors with respect to the rights includes, but is not
limited to, the determination of (1) the initial purchase
price per share of the capital stock or other securities of
Catalyst Pharmaceutical Partners to be purchased upon exercise
of the rights, (2) provisions relating to the times at
which and the circumstances under which the rights may be
exercised or sold or otherwise transferred, either together with
or separately from, any other securities of Catalyst
Pharmaceutical Partners, (3) antidilutive provisions which
adjust the number or exercise price of the rights or amount or
nature of the securities or other property receivable upon
exercise of the rights, (4) provisions which deny the
holder of a specified percentage of the outstanding securities
of Catalyst Pharmaceutical Partners the right to exercise the
rights and/or cause the rights held by such holder to become
void, (5) provisions which permit Catalyst Pharmaceutical
Partners to redeem the rights and (6) the appointment of a
rights agent with respect to the rights.
Meetings of Stockholders. The by-laws provide that a
special meeting of stockholders may be called only by the board
of directors unless otherwise required by law. The by-laws
provide that only those matters set forth in the notice of the
special meeting may be considered or acted upon at that special
meeting, unless otherwise provided by law. In addition, the
by-laws set forth certain advance notice and informational
requirements and time limitations on any director nomination or
any new business which a stockholder wishes to propose for
consideration at an annual meeting of stockholders.
No Stockholder Action by Written Consent. The certificate
provides that any action required or permitted to be taken by
our stockholders at an annual or special meeting of stockholders
must be effected at a duly called meeting and may not be taken
or effected by a written consent of stockholders in lieu thereof.
Amendment of the Certificate. The certificate provides
that an amendment thereof must first be approved by a majority
of the board of directors and (with certain exceptions)
thereafter approved by the holders of a majority of the total
votes eligible to be cast by holders of voting stock with
respect to such amendment or repeal; provided, however, that the
affirmative vote of 80% of the total votes eligible to be cast
by holders of voting stock, voting together as a single class,
is required to amend provisions relating to the establishment of
the board of directors and amendments to the certificate.
Amendment of the By-laws. The certificate provides that
the board of directors or the stockholders may amend or repeal
the by-laws. Such action by the board of directors requires the
affirmative vote of a majority of the directors then in office.
Such action by the stockholders requires the affirmative vote of
the holders of at least two-thirds of the total votes eligible
to be cast by holders of voting stock with respect to such
amendment or repeal at an annual meeting of stockholders or a
special meeting called for such purposes, unless the board of
directors recommends that the stockholders approve such
amendment or repeal at such meeting, in which case such
amendment or repeal shall only require the affirmative vote of a
majority of the total votes eligible to be cast by holders of
voting stock with respect to such amendment or repeal.
63
Provisions of Delaware Law
We will be subject to the provisions of Section 203 of the
Delaware General Corporation Law, or Delaware law, regulating
corporate takeovers. In general, these provisions prohibit a
Delaware corporation from engaging in any business combination
with any interested stockholders for a period of three years
following the date that the stockholder became an interested
stockholder, unless:
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either the business combination or the transaction that resulted
in the stockholder becoming an interested stockholder is
approved by our board of directors before the date the
interested stockholder attained that status; |
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Upon consummation of the transaction that resulted in the
stockholder becoming an interested stockholder, the interested
stockholder owned at least 85% of the voting stock of the
corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the voting stock
outstanding (but not the outstanding voting stock owned by the
interested stockholder) those shares owned (i) by persons
who are directors and also officers and (ii) employee stock
plans in which employee participates do not have the right to
determine confidentially whether shares held subject to the plan
will be tendered in a tender or exchange offer; or |
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On or after that date, the business combination is approved by
our board of directors and authorized at a meeting of
stockholders, and not by written consent, by at least two-thirds
of the outstanding voting stock that is not owned by the
interested stockholder. |
Section 203 defines business combination to
include the following:
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Any merger or consolidation involving the corporation and the
interested stockholder; |
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Any sale, transfer, pledge or other disposition of 10% or more
of the assets of the corporation involving the interested
stockholder; |
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Subject to certain exceptions, any transaction that results in
the issuance or transfer by the corporation of any stock of the
corporation to the interested stockholder; |
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Any transaction involving the corporation that has the effect of
increasing the proportionate share of the stock of any class or
series of the corporation beneficially owned by the interested
stockholder; or |
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The receipt by the interested stockholder of the benefit of any
loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation. |
In general, Section 203 defines an interested stockholder
as any entity or person beneficially owning 15% or more of the
outstanding voting stock of the corporation and any entity or
person affiliated with or controlling or controlled by any of
these entities or persons.
A Delaware corporation may opt out of this provision either with
an express provision in its original certificate of
incorporation or in an amendment to its certificate of
incorporation or by-laws approved by its stockholders. However,
we have not opted out of this provision. The statute could
prohibit or delay mergers or other takeover or change in control
attempts and, accordingly, may discourage attempts to acquire us.
Transfer Agent
The transfer agent for our common stock is Continental Stock
Transfer & Trust Company, 17 Battery Place, 8th Floor,
New York, New York 10004. Continental Stock Transfer &
Trust Company can be reached at (212) 509-4000.
64
SHARES ELIGIBLE FOR FUTURE SALE
General
Upon completion of this offering, there will
be shares
of our common stock outstanding. Of the shares which will be
outstanding after the offering:
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all shares
of common stock sold in the offering will be freely tradeable; |
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shares
will be restricted securities held by
non-affiliates; and |
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shares
will be held by our executive officers and directors. |
The restricted securities described above are eligible for sale
in the public market, subject to volume limitations, manner of
sale provisions and other requirements of Rule 144, from
time to time.
Rule 144
In general, under Rule 144 as currently in effect, a person
who has beneficially owned restricted securities for
at least one year, including an affiliate, is entitled to sell,
within any three-month period, a number of shares that does not
exceed the greater of:
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one percent of the then outstanding shares of our common stock
(approximately shares
immediately following the offering); or |
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the average weekly trading volume during the four calendar weeks
preceding filing of notice of such sale. |
A person (or persons whose shares are aggregated) who is not
deemed to have been an affiliate of ours at any time during the
90 days preceding a sale and who owns shares that were
acquired from us or an affiliate of ours for at least two years
prior to the proposed sale is entitled to sell such shares
pursuant to Rule 144(k) without regard to the volume
limitations, manner of sale provisions or other limitations of
Rule 144.
Shares held by our executive officers and directors may be sold
in the public market, subject to the volume, manner of sale and
other limitations of Rule 144, but may not be sold in
reliance upon Rule 144(k).
Lock-up Agreements
In addition to the limits placed on the sale of shares of our
common stock by operation of Rule 144 and other provisions
of the Securities Act of 1933, as amended, we, our directors and
executive officers and holders
of %
of our common stock (assuming the automatic conversion of all of
our shares of Series A Preferred Stock and Series B
Preferred Stock upon the closing of this offering), have entered
into lock-up agreements with the underwriters. Under these
agreements, subject to certain, limited exceptions, we may not
issue any new shares of common stock, and those holders of stock
may not, directly or indirectly, offer, sell, contract to sell,
pledge or otherwise dispose of or hedge any common stock or
securities convertible into or exchangeable for shares of common
stock, or publicly announce the intention to do any of the
foregoing, without the prior written consent of First Albany
Capital, Inc. for a period of 180 days from the date of
this prospectus. This consent may be given at any time without
public notice. If we issue an earnings release or material news
or a material event relating to us occurs during the 15 calendar
days plus 3 business days before the last day of the lock-up
period, or if prior to the expiration of the lock-up period, we
announce that we will release earnings results during the
16 days following the last day of the lock-up period, the
restrictions provided in the lock-up agreements will continue to
apply until 15 calendar days plus 3 business days after the
issuance of the earnings release or the occurrence of material
news or a material event. Also, during this 180-day period, we
have agreed not to file any registration statement for, any
shares of common stock or any securities convertible into or
exercisable or exchangeable for common stock without the prior
written consent of First Albany Capital, Inc.
65
MATERIAL U.S. FEDERAL INCOME AND ESTATE TAX
CONSEQUENCES
TO NON-U.S. HOLDERS
The following is a general discussion of the material
U.S. federal income and estate tax consequences of the
ownership and disposition of our common stock by a
non-U.S. holder that acquires our common stock pursuant to
this offering. The discussion is based on provisions of the
Internal Revenue Code of 1986, as amended (the
Code), applicable U.S. Treasury regulations
promulgated thereunder and administrative and judicial
interpretations, all as in effect on the date of this
prospectus, and all of which are subject to change, possibly on
a retroactive basis. The discussion is limited to
non-U.S. holders that hold our common stock as a
capital asset within the meaning of
Section 1221 of the Code (generally, property held for
investment). As used in this discussion, the term
non-U.S. holder means a beneficial owner of our
common stock that is not, for U.S. federal income tax
purposes:
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an individual who is a citizen or resident of the United States; |
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a corporation (including any entity treated as a corporation for
U.S. federal income tax purposes) created or organized in
or under the laws of the United States or any State of the
United States or the District of Columbia; |
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an estate the income of which is includible in gross income for
U.S. federal income tax purposes regardless of its source;
or |
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a trust (1) if a U.S. court is able to exercise
primary supervision over the administration of the trust and one
or more U.S. persons have authority to control all
substantial decisions of the trust, or (2) that has a valid
election in effect under applicable U.S. Treasury
regulations to be treated as a U.S. person. |
If a partnership or other pass-through entity holds common
stock, the tax treatment of a partner or member in the
partnership or other entity will generally depend on the status
of the partner or member and upon the activities of the
partnership or other entity. This discussion does not address
the U.S. federal income or estate tax consequences
applicable to any person who holds our common stock through a
partnership or other entity treated as a partnership, or any
other form of pass through-through entity, for U.S. federal
tax purposes or the tax consequences to such partnership or
other entity. Accordingly, we urge partnerships and other
pass-through entities which hold our common stock and partners
and members in these partnerships and other entities to consult
their tax advisors.
This discussion also does not consider:
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U.S. federal gift tax consequences, or any U.S. state
or local or non-U.S. tax consequences; |
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the tax consequences for the stockholders or beneficiaries of a
non-U.S. holder; |
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any U.S. federal tax considerations that may be relevant to
a non-U.S. holder in light of its particular circumstances
or to non-U.S. holders that may be subject to special
treatment under U.S. federal tax laws, such as financial
institutions, insurance companies, tax exempt organizations,
certain trusts, hybrid entities, certain former citizens or
residents of the United States, holders subject to the
U.S. federal alternative minimum tax, broker-dealers,
controlled foreign corporations, passive foreign investment
companies, and dealers and traders in securities; or |
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special tax rules that may apply to a non-U.S. holder that
holds our common stock as part of a straddle,
hedge, conversion transaction,
synthetic security, or other integrated investment. |
This discussion is for general purposes only. Prospective
investors are urged to consult their own tax advisors regarding
the application of the U.S. federal income and estate tax
laws to their particular situations and the consequences under
U.S. federal gift tax laws, as well as foreign, state, and
local laws and tax treaties.
66
Dividends
As previously discussed, we do not anticipate paying dividends
on our common stock. See Dividend Policy. If we pay
dividends on our common stock, those payments will constitute
dividends for U.S. federal income tax purposes to the
extent paid from our current or accumulated earnings and
profits, as determined under U.S. federal income tax
principles. To the extent those dividends exceed our current and
accumulated earnings and profits, for U.S. federal income tax
purposes, the dividends will constitute a return of capital and
first reduce the non-U.S. holders basis, but not
below zero, and then will be treated as gain from the sale of
stock.
We will be required to withhold U.S. federal income tax at
a rate of 30%, or a lower rate under an applicable income tax
treaty, from the gross amount of amounts constituting dividends
as determined under U.S. federal income tax principles (as
described above) paid to a non-U.S. holder, unless the
dividend is effectively connected with the conduct of a trade or
business of the non-U.S. holder within the United States
and, if an income tax treaty applies, attributable to a
permanent establishment of the non-U.S. holder within the
United States. Under applicable U.S. Treasury regulations,
a non-U.S. holder (including, in certain cases of
non-U.S. holders that are entities, the owner or owners of
such entities) will be required to satisfy certain certification
requirements in order to claim a reduced rate of withholding
pursuant to an applicable income tax treaty.
Non-U.S. holders should consult their tax advisors
regarding their entitlement to benefits under a relevant income
tax treaty.
Dividends that are effectively connected with a
non-U.S. holders conduct of a trade or business in
the United States and, if an income tax treaty applies,
attributable to a permanent establishment in the United States,
are taxed on a net income basis at the regular graduated
U.S. federal income tax rates in the same manner as if the
non-U.S. holder were a resident of the United States. In
such cases, we will not have to withhold U.S. federal
income tax if the non-U.S. holder complies with applicable
certification and disclosure requirements. In addition, a
branch profits tax may be imposed at a 30% rate, or
a lower rate under an applicable income tax treaty, on dividends
received by a foreign corporation that are effectively connected
with the foreign corporations conduct of a trade or
business in the United States.
In order to claim the benefit of an income tax treaty or to
claim exemption from withholding because the income is
effectively connected with the conduct of a trade or business in
the United States (or, if an income tax treaty applies, because
the income is effectively connected with the conduct of a trade
or business of the non-U.S. holder within the United States
through a permanent establishment situated in the United
States), the non-U.S. holder must provide a properly
executed IRS Form W-8BEN, for treaty benefits, or W-8ECI,
for effectively connected income, respectively (or such
successor forms as the IRS designates), prior to the payment of
dividends. These forms must be periodically updated.
A non-U.S. holder that is eligible for a reduced rate of
U.S. federal withholding tax under an income tax treaty may
obtain a refund of any excess amounts withheld by filing an
appropriate claim for a refund together with the required
information with the IRS.
Gain on Disposition of Common Stock
A non-U.S. holder generally will not be subject to
U.S. federal income or withholding tax with respect to gain
realized on a sale or other disposition of our common stock
unless one of the following applies
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the gain is effectively connected with the
non-U.S. holders conduct of a trade or business in
the United States and, if an income tax treaty applies, is
attributable to a permanent establishment maintained by the
non-U.S. holder in the United States; in these cases, the
non-U.S. holder generally will be taxed on its net gain
derived from the disposition at the regular graduated rates and
in the manner applicable to U.S. persons and, if the
non-U.S. holder is a foreign corporation, the branch
profits tax referred to above may also apply; |
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the non-U.S. holder is an individual who is present in the
United States for 183 days or more in the taxable year of
the disposition and certain other conditions are met; in this
case, unless an applicable income tax treaty provides otherwise,
the non-U.S. holder generally will be subject to a 30% U.S.
federal income tax on the gain derived from the disposition; or |
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our common stock constitutes a United States real property
interest by reason of our status as a United States real
property holding corporation, or a USRPHC, for
U.S. federal income tax purposes at any time during the
shorter of the 5 year period ending on the date of such
disposition or the period that the non-U.S. holder held our
common stock. While we believe that we are not currently, and
will not become, a USRPHC, the determination of whether we are a
USRPHC depends on the fair market value of our United States
real property interests relative to the fair market value of our
other business assets, and accordingly there can be no assurance
that we will not become a USRPHC in the future. However, as long
as our common stock is regularly traded on an established
securities market within the meaning of
Section 897(c)(3) of the Code, a non-U.S. holder would
be subject to U.S. federal income tax on any gain from the
sale, exchange or other disposition of our shares of common
stock, by reason of USRPHC status, only if such
non-U.S. holder, actually or constructively, owned more
than 5% of our common stock at some time during the shorter of
the periods described above. On the other hand, if we are or
were to become a USRPHC and were to fail to qualify as
regularly traded on an established securities
market, then a non-U.S. holder generally would be
subject to U.S. federal income tax on net gain derived from
the disposition of our common stock at regular graduated rates
and may be subject to U.S. federal income tax withholding on the
gross proceeds realized with respect to such disposition. A
non-U.S. holder may obtain a refund of any such amounts
withheld in excess of the non-U.S. holders federal
income tax liability. |
Federal Estate Tax
Shares of our common stock owned or treated as owned by an
individual who is a non-U.S. holder at the time of death
(including by reason of certain lifetime transfers of interests
therein) will be included in the individuals gross estate
for U.S. federal estate tax purposes and, unless an
applicable estate tax or other treaty provides otherwise, may be
subject to U.S. federal estate tax.
Information Reporting and Backup Withholding Tax
We must report annually to the IRS and to each
non-U.S. holder the amount of dividends paid to that holder
and the tax withheld from those dividends.
These reporting requirements apply regardless of whether
withholding was reduced or eliminated by an applicable income
tax treaty. Copies of the information returns reporting those
dividends and withholding may also be made available under the
provisions of an applicable income tax treaty or agreement to
the tax authorities in the country in which the
non-U.S. holder is a resident. Under some circumstances,
U.S. Treasury regulations require backup withholding and
additional information reporting on reportable payments on
common stock. The gross amount of dividends paid to a
non-U.S. holder that fails to certify its
non-U.S. holder status in accordance with applicable
U.S. Treasury regulations generally will be reduced by
backup withholding at the applicable rate (currently 28%).
In general, backup withholding and information reporting will
not apply to the payment of the proceeds of sale or other
disposition of common stock made to a non-U.S. holder if
the non-U.S. holder provides any required certifications.
Backup withholding is not an additional tax. Any amounts
withheld under the backup withholding rules from a payment to a
non-U.S. holder can be refunded or credited against the
non-U.S. holders U.S. federal income tax
liability, if any, provided that the required information is
furnished to the IRS in a timely manner.
68
These backup withholding and information reporting rules are
complex and non-U.S. holders are urged to consult their own
tax advisors regarding the application of these rules to them.
The foregoing discussion of U.S. federal income and
estate tax considerations is not tax advice. Accordingly, each
prospective non-U.S. holder of our common stock should
consult that holders own tax advisor with respect to the
federal, state, local and non-U.S. tax consequences of the
ownership and disposition of our common stock.
69
UNDERWRITING
We are offering the shares of our common stock through the
underwriters named below. We have applied to have our common
stock included for quotation on the Nasdaq Global Market under
the symbol CPRX.
The Underwriters and the Underwriting Agreement
We and the underwriters named below have entered into an
underwriting agreement relating to this offering. First Albany
Capital Inc. and Stifel, Nicolaus & Company, Incorporated
are the representatives of the underwriters.
The underwriters have severally agreed, subject to the terms and
conditions of the underwriting agreement, to purchase from us
the number of shares indicated in the following table:
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First Albany Capital Inc.
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Stifel, Nicolaus & Company, Incorporated
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Total
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Except for the underwriters over-allotment option
described below, the underwriters must take and pay for all of
the shares, if they take any shares.
We have granted to the underwriters the option to purchase from
us up to an
additional shares
of our common stock to cover over-allotments, if any, made in
connection with this offering. First Albany Capital Inc., on
behalf of the underwriters, may exercise this option at any
time, from time to time, on or before the 30th day after the
date of this prospectus. If First Albany Capital Inc. exercises
this option, the underwriters will each severally purchase
shares in approximately the same proportion as set forth in the
table above. The underwriters are not obligated to purchase any
of these additional shares if they do not exercise their
over-allotment option.
We have agreed to indemnify the underwriters and their partners,
directors, officers and controlling persons against certain
liabilities, including liabilities under the Securities Act of
1933, as amended. If we are unable to provide this
indemnification, we have agreed to contribute to payments the
underwriters and these persons may be required to make in
respect of those liabilities.
Public Offering Price, Commissions and Discounts and Offering
Expenses
The underwriters will initially offer the shares to the public
at the public offering price set forth on the cover of this
prospectus. If all the shares are not sold at this public
offering price, the representatives may change the public
offering price or any other selling term.
Shares sold by the underwriters to securities dealers may be
sold at a discount of up to
$ per
share from the public offering price. Any of these securities
dealers may resell any shares purchased from the underwriters to
other brokers or dealers at a discount of up to
$ per
share from the public offering price.
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The table below shows the per share and total underwriting
discounts and commissions we will pay to the underwriters,
assuming both no exercise and full exercise of the
underwriters option to purchase up to an
additional shares:
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Per share
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Total
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We estimate that the total expenses of this offering payable by
us, not including the underwriting discounts and commissions,
will be approximately $.
Lock-Up Agreements
We, each of our officers and directors, and stockholders owning
substantially all of our outstanding common stock have entered
into lock-up agreements with the underwriters. Subject to
certain exceptions, these lock-up agreements generally prohibit
us and each of these persons, without the prior written consent
of First Albany Capital Inc., from selling, offering to sell,
contracting to sell, hypothecating, pledging, granting an option
to purchase or otherwise disposing of any shares of our common
stock or securities convertible into or exchangeable or
exercisable for common stock or any warrants or other rights to
purchase common stock or such securities. These restrictions
will be in effect for 180 days after the date of this
prospectus. However, if we issue an earnings release or
significant news or a significant event relating to us occurs,
or if we announce during the 16-day period beginning on the last
day the restrictions would otherwise apply, then the
restrictions applicable to our officers, directors and
stockholders will continue to apply for 15 calendar days plus
three business days from the date we issue the earnings release
or the date the significant news or event occurs. At any time
and without public notice, First Albany Capital Inc. may in its
sole discretion release all or some of the securities from these
lock-up agreements.
Stabilization and Short Positions
In connection with this offering, the underwriters may engage in
activities that stabilize, maintain or otherwise affect the
price of our common stock. These activities include stabilizing
transactions, syndicate short covering and penalty bids. The
underwriters may carry out these activities on the Nasdaq Global
Market, in the over-the-counter market or otherwise. As a result
of these activities, the price of our common stock may be higher
than the price that may otherwise exist in the open market. If
these activities are commenced, they may be discontinued by the
underwriters at any time.
Stabilizing Transactions and Syndicate Short Covering.
Stabilizing transactions consist of placing a bid or effecting a
purchase for the purpose of pegging, fixing or maintaining the
price of a security. Stabilizing activities may include
purchases to cover short positions created by short sales. Short
sales are sales by the underwriters in excess of the number of
shares they are obligated to purchase from us in this offering.
Short sales create short positions that can be either
covered or naked. A covered short
position is a short position in an amount that does not exceed
the number of shares the underwriters may purchase from us by
exercising their over-allotment option described above. A naked
short position is a short position in excess of that amount.
The underwriters may close out a covered short position either
by exercising their over-allotment option, in whole or in part,
or by purchasing shares in the open market. In determining the
source of shares to close out a covered short position, the
underwriters will consider, among other things, the price of
shares available for purchase in the open market compared to the
price at which the underwriters may purchase shares by
exercising their over-allotment option. The underwriters must
close out a naked short position by purchasing shares in the
open market. A naked short position is more likely to be created
if the underwriters are concerned that there
71
may be downward pressure on the price of the common stock in the
open market that could adversely affect investors who purchased
shares in this offering.
Penalty Bids. The underwriters may impose a penalty bid.
This occurs when a particular underwriter repays to the
underwriters a portion of the underwriting discount received by
it because the representatives have repurchased shares sold by
or for the account of that underwriter in stabilizing or short
covering transactions.
Determination of Offering Price
Prior to this offering, there was no public market for our
common stock. The initial public offering price will be
determined by negotiation between us and the representatives of
the underwriters. The principal factors to be considered in
determining the initial public offering price include:
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the information set forth in this prospectus and otherwise
available to representatives; |
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our history and prospects, and the history of and prospects for
the industry in which we compete; |
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our past and present financial performance and an assessment of
our management; |
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our prospects for future earnings and the present state of our
development; |
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the general condition of the securities markets at the time of
this offering; |
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the recent market prices of, and demand for, publicly traded
common stock of generally comparable companies; and |
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other factors deemed relevant by the underwriters and us. |
Affiliations
Certain of the underwriters and their respective affiliates have
from time to time performed and may in the future perform
various commercial banking, financial advisory and investment
banking services for us, for which they have received or will
receive customary fees.
72
NOTICE TO INVESTORS
European Economic Area
In relation to each Member State of the European Economic Area
(EEA) which has implemented the Prospectus Directive
(each, a Relevant Member State), with effect from
and including the date on which the Prospectus Directive is
implemented in that Relevant Member State (the Relevant
Implementation Date) our common stock will not be offered
to the public in that Relevant Member State prior to the
publication of a prospectus in relation to our common stock that
has been approved by the competent authority in that Relevant
Member State or, where appropriate, approved in another Relevant
Member State and notified to the competent authority in that
Relevant Member State, all in accordance with the Prospectus
Directive, except that, with effect from and including the
Relevant Implementation Date, our common stock may be offered to
the public in that Relevant Member State at any time:
(a) to legal entities which are authorized or regulated to
operate in the financial markets or, if not so authorized or
regulated, whose corporate purpose is solely to invest in
securities;
(b) to any legal entity which has two or more of (1) an
average of at least 250 employees during the last financial
year; (2) a total balance sheet of more than
43,000,000 and
(3) an annual net turnover of more than
50,000,000, as
shown in its last annual or consolidated accounts; or
(c) in any other circumstances which do not require the
publication by us of a prospectus pursuant to Article 3 of
the Prospectus Directive.
As used above, the expression offered to the public
in relation to any of our common stock in any Relevant Member
State means the communication in any form and by any means of
sufficient information on the terms of the offer and our common
stock to be offered so as to enable an investor to decide to
purchase or subscribe for our common stock, as the same may be
varied in that Member State by any measure implementing the
Prospectus Directive in that Member State and the expression
Prospectus Directive means Directive 2003/71/EC and
includes any relevant implementing measure in each Relevant
Member State.
The EEA selling restriction is in addition to any other selling
restrictions set out below.
United Kingdom
Our common stock may not be offered or sold and will not be
offered or sold to any persons in the United Kingdom other than
to persons whose ordinary activities involve them in acquiring,
holding, managing or disposing of investments (as principal or
as agent) for the purposes of their businesses and in compliance
with all applicable provisions of the Financial Services and
Markets Act 2000 (FSMA) with respect to anything
done in relation to our common stock in, from or otherwise
involving the United Kingdom. In addition, each underwriter has
only communicated or caused to be communicated and will only
communicate or cause to be communicated any invitation or
inducement to engage in investment activity (within the meaning
of Section 21 of the FSMA) received by it in connection
with the issue or sale of our common stock in circumstances in
which Section 21(1) of the FSMA does not apply to us.
Without limitation to the other restrictions referred to herein,
this prospectus is directed only at (1) persons outside the
United Kingdom; (2) persons having professional experience
in matters relating to investments who fall within the
definition of investment professionals in
Article 19(5) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005; or (3) high net
worth bodies corporate, unincorporated associations and
partnerships and trustees of high value trusts as described in
Article 49(2) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005. Without limitation to the
other restrictions referred to herein, any investment or
investment activity to which this prospectus relates is
available only to, and will be engaged in only with, such
persons, and persons within the United Kingdom who receive this
communication (other than persons who fall within (2) or
(3) above) should not rely or act upon this communication.
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France
No prospectus (including any amendment or replacement thereto)
has been prepared in connection with the offering of our common
stock that has been approved by the Autorité des
marchés financiers or by the competent authority of
another State that is a contracting party to the Agreement on
the European Economic Area and notified to the Autorité
des marchés financiers; no common stock has been
offered or sold and will be offered or sold, directly or
indirectly, to the public in France except to permitted
investors (Permitted Investors) consisting of
persons licensed to provide the investment service of portfolio
management for the account of third parties, qualified investors
(investisseurs qualifiés) acting for their own
account and/or corporate investors meeting one of the four
criteria provided in Article 1 of Decree N° 2004-1019
of September 28, 2004 and belonging to a limited circle of
investors (cercle restreint dinvestisseurs) acting
for their own account, with qualified investors and
limited circle of investors having the meaning
ascribed to them in Article L. 411-2 of the French Code
Monétaire et Financier and applicable regulations
thereunder; none of this prospectus or any other materials
related to the offer or information contained therein relating
to our common stock has been released, issued or distributed to
the public in France except to Permitted Investors; and the
direct or indirect resale to the public in France of any common
stock acquired by any Permitted Investors may be made only as
provided by articles L. 412-1 and L. 621-8 of the French
Code Monétaire et Financier and applicable
regulations thereunder.
Italy
The offering of shares of our common stock has not been cleared
by the Italian Securities Exchange Commission (Commissione
Nazionale per le Società e la Borsa, the
CONSOB) pursuant to Italian securities legislation
and, accordingly, shares of our common stock may not and will
not be offered, sold or delivered, nor may or will copies of
this prospectus or any other documents relating to shares of our
common stock or the offering be distributed in Italy other than
to professional investors (operatori qualificati), as defined in
Article 31, paragraph 2 of CONSOB
Regulation No. 11522 of July 1, 1998, as amended
(Regulation No. 11522).
Any offer, sale or delivery of shares of our common stock or
distribution of copies of this prospectus or any other document
relating to shares of our common stock or the offering in Italy
may and will be effected in accordance with all Italian
securities, tax, exchange control and other applicable laws and
regulations, and, in particular, will be: (i) made by an
investment firm, bank or financial intermediary permitted to
conduct such activities in Italy in accordance with the
Legislative Decree No. 385 of September 1, 1993, as
amended (the Italian Banking Law), Legislative
Decree No. 58 of February 24, 1998, as amended,
Regulation No. 11522, and any other applicable laws
and regulations; (ii) in compliance with Article 129
of the Italian Banking Law and the implementing guidelines of
the Bank of Italy; and (iii) in compliance with any other
applicable notification requirement or limitation which may be
imposed by CONSOB or the Bank of Italy.
Any investor purchasing shares of our common stock in the
offering is solely responsible for ensuring that any offer or
resale of shares of common stock it purchased in the offering
occurs in compliance with applicable laws and regulations.
This prospectus and the information contained herein are
intended only for the use of its recipient and are not to be
distributed to any third party resident or located in Italy for
any reason. No person resident or located in Italy other than
the original recipients of this document may rely on it or its
content.
In addition to the above (which shall continue to apply to the
extent not inconsistent with the implementing measures of the
Prospective Directive in Italy), after the implementation of the
Prospectus Directive in Italy, the restrictions, warranties and
representations set out under the heading European
Economic Area above shall apply to Italy.
74
Spain
Neither the common stock nor this prospectus have been approved
or registered in the administrative registries of the Spanish
National Securities Exchange Commission (Comisión
Nacional del Mercado de Valores). Accordingly, our common
stock may not be offered in Spain except in circumstances which
do not constitute a public offer of securities in Spain within
the meaning of articles 30bis of the Spanish Securities
Markets Law of 28 July 1988 (Ley 24/1988, de 28 de
Julio, del Mercado de Valores), as amended and restated, and
supplemental rules enacted thereunder.
Sweden
This is not a prospectus under, and has not been prepared in
accordance with the prospectus requirements provided for in, the
Swedish Financial Instruments Trading Act (lagen
(1991:980) om handel med finasiella instrument) nor any
other Swedish enactment. Neither the Swedish Financial
Supervisory Authority nor any other Swedish public body has
examined, approved, or registered this document.
Switzerland
The common stock may not and will not be publicly offered,
distributed or re-distributed on a professional basis in or from
Switzerland and neither this prospectus nor any other
solicitation for investments in our common stock may be
communicated or distributed in Switzerland in any way that could
constitute a public offering within the meaning of
Articles 1156 or 652a of the Swiss Code of Obligations or
of Article 2 of the Federal Act on Investment Funds of
March 18, 1994. This prospectus may not be copied,
reproduced, distributed or passed on to others without the
underwriters prior written consent. This prospectus is not
a prospectus within the meaning of Articles 1156 and 652a
of the Swiss Code of Obligations or a listing prospectus
according to article 32 of the Listing Rules of the Swiss
Exchange and may not comply with the information standards
required thereunder. We will not apply for a listing of our
common stock on any Swiss stock exchange or other Swiss
regulated market and this prospectus may not comply with the
information required under the relevant listing rules. The
common stock offered hereby has not and will not be registered
with the Swiss Federal Banking Commission and has not and will
not be authorized under the Federal Act on Investment Funds of
March 18, 1994. The investor protection afforded to
acquirers of investment fund certificates by the Federal Act on
Investment Funds of March 18, 1994 does not extend to
acquirers of our common stock.
LEGAL MATTERS
Our counsel, Akerman Senterfitt, in Miami, Florida, will pass on
the validity of shares of common stock offered by this
prospectus. Philip B. Schwartz, a shareholder of Akerman
Senterfitt, is our corporate secretary and currently owns 90,000
shares of our outstanding common stock. Dewey Ballantine LLP,
New York, New York is counsel to the underwriters in connection
with this offering.
EXPERTS
Grant Thornton LLP, our independent registered public accounting
firm, has audited our financial statements as set forth in their
report, which is included herein. We have included our financial
statements in this prospectus in reliance on such report, given
on the authority of Grant Thornton LLP as experts in accounting
and auditing in giving said report.
75
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on
Form S-1 under the Securities Act that registers the shares
of our common stock to be sold in this offering. This prospectus
does not contain all of the information set forth in the
registration statement with the exhibits and schedules filed as
part of the registration statement. For further information with
respect to us and our common stock, we refer you to the
registration statement and the exhibits and schedules filed as a
part of the registration statement. Statements contained in this
prospectus concerning the contents of any contract or any other
document are not necessary complete. If a contract or document
has been filed as an exhibit to the registration statement, we
refer you to the copy of the contract or document that has been
filed with the SEC. Each statement in this prospectus relating
to a contract or document filed as an exhibit is qualified in
all respects by the filed exhibit.
The reports and other information we file with the SEC can be
read and copied at the SECs Public Reference Room at 100
F. Street, N.E., Washington, D.C. 20549. Copies of these
materials can be obtained at prescribed rates from the
SECs Public Reference Room at such address. You may obtain
information regarding the operation of the public reference room
by calling 1-800-SEC-0330. The SEC also maintains a website
(http://www.sec.gov) that contains reports, proxy and
information statements and other information regarding issuers
that file electronically with the SEC. Upon completion of this
offering, we will become subject to the reporting and
information requirements of the Securities Exchange Act of 1934,
and, as a result, will file periodic reports, proxy statements,
and other information with the SEC. These periodic reports,
proxy statements and other information will be available for
inspecting and copying at the SECs public reference room
and the website of the SEC referred to above.
76
INDEX TO FINANCIAL STATEMENTS
|
|
|
|
|
Years ended December 31, 2005, 2004 and 2003
|
|
|
|
|
|
|
|
F-2 |
|
|
|
|
F-3 |
|
|
|
|
F-4 |
|
|
|
|
F-5 |
|
|
|
|
F-6 |
|
|
|
|
F-7 |
|
Six months ended June 30, 2006 and 2005
|
|
|
|
|
|
|
|
F-14 |
|
|
|
|
F-15 |
|
|
|
|
F-16 |
|
|
|
|
F-17 |
|
|
|
|
F-18 |
|
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors
Catalyst Pharmaceutical Partners
We have audited the accompanying balance sheets of Catalyst
Pharmaceutical Partners, Inc. (a Development Stage Company) (the
Company) as of December 31, 2005 and 2004, and
the related statements of operations, stockholders equity
and cash flows for each of the three years in the period ended
December 31, 2005 and the period from January 4, 2002
(date of inception) through December 31, 2005. These
financial statements are the responsibility of the
Companys management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes consideration
of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the Companys internal control over
financial reporting. Accordingly, we express no such opinion. An
audit also includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating
the overall financial statement presentation. We believe that
our audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the financial position
of Catalyst Pharmaceutical Partners, Inc. (a Development Stage
Company) as of December 31, 2005 and 2004, and the results
of its operations and its cash flows for each of the three years
in the period ended December 31, 2005 and the period from
January 4, 2002 (date of inception) through
December 31, 2005, in conformity with accounting principles
generally accepted in the United States of America.
/s/ Grant Thorton LLP
Miami, Florida
July 24, 2006
F-2
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
771,127 |
|
|
$ |
183,911 |
|
|
Prepaid insurance
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
771,567 |
|
|
|
183,911 |
|
|
Property and equipment, net
|
|
|
4,031 |
|
|
|
1,465 |
|
|
Deposits
|
|
|
13,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
789,450 |
|
|
$ |
185,376 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
67,753 |
|
|
$ |
30,734 |
|
|
Accrued expenses
|
|
|
275,235 |
|
|
|
37,066 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
342,988 |
|
|
|
67,800 |
|
|
|
|
|
|
|
|
Commitments and contingencies (See notes)
|
|
|
|
|
|
|
|
|
Stockholders equity
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value, 5,000,000 shares authorized,
70,000 shares Series A Preferred Stock issued and
outstanding
|
|
|
700 |
|
|
|
700 |
|
|
Common stock, $.01 par value, 30,000,000 shares authorized,
4,720,000 shares issued and outstanding at December 31,
2005 and 2,000,000 shares issued and outstanding at
December 31, 2004
|
|
|
47,200 |
|
|
|
20,000 |
|
|
Additional paid-in capital
|
|
|
3,428,322 |
|
|
|
1,321,256 |
|
|
Deficit accumulated during the development stage
|
|
|
(3,029,760 |
) |
|
|
(1,224,380 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
446,462 |
|
|
|
117,576 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$ |
789,450 |
|
|
$ |
185,376 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-3
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative Period | |
|
|
|
|
|
|
|
|
from January 4, | |
|
|
|
|
2002 (date of | |
|
|
Years Ended December 31, | |
|
inception) through | |
|
|
| |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
| |
Revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
290,139 |
|
|
|
83,421 |
|
|
|
172,996 |
|
|
|
608,403 |
|
|
General and Administrative
|
|
|
359,279 |
|
|
|
164,704 |
|
|
|
165,483 |
|
|
|
807,731 |
|
|
Non-cash compensation
|
|
|
1,172,750 |
|
|
|
294,833 |
|
|
|
95,833 |
|
|
|
1,639,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
1,822,168 |
|
|
|
542,958 |
|
|
|
434,312 |
|
|
|
3,055,383 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(1,822,168 |
) |
|
|
(542,958 |
) |
|
|
(434,312 |
) |
|
|
(3,055,383 |
) |
Interest income
|
|
|
16,788 |
|
|
|
3,138 |
|
|
|
5,697 |
|
|
|
25,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(1,805,380 |
) |
|
|
(539,820 |
) |
|
|
(428,615 |
) |
|
|
(3,029,760 |
) |
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
|
$ |
(3,029,760 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share-basic and diluted
|
|
$ |
(0.42 |
) |
|
$ |
(0.27 |
) |
|
$ |
(0.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Shares outstanding basic and diluted
|
|
|
4,252,219 |
|
|
|
2,000,000 |
|
|
|
2,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-4
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENT OF STOCKHOLDERS EQUITY
for the period from January 4, 2002 (date of inception)
through December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
|
|
During the | |
|
|
|
|
|
|
|
|
|
|
Development | |
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Paid-in Capital | |
|
Stage | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at January 4, 2002 (date of inception)
|
|
$ |
|
|
|
$ |
15,000 |
|
|
$ |
85,000 |
|
|
$ |
|
|
|
$ |
100,000 |
|
|
Issuance of common stock
|
|
|
|
|
|
|
5,000 |
|
|
|
120,000 |
|
|
|
|
|
|
|
125,000 |
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
75,833 |
|
|
|
|
|
|
|
75,833 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(255,945 |
) |
|
|
(255,945 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
|
|
|
|
20,000 |
|
|
|
280,833 |
|
|
|
(255,945 |
) |
|
|
44,888 |
|
|
Issuance of preferred stock
|
|
|
700 |
|
|
|
|
|
|
|
669,757 |
|
|
|
|
|
|
|
670,457 |
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
75,833 |
|
|
|
|
|
|
|
75,833 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(428,615 |
) |
|
|
(428,615 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
700 |
|
|
|
20,000 |
|
|
|
1,026,423 |
|
|
|
(684,560 |
) |
|
|
362,563 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
294,833 |
|
|
|
|
|
|
|
294,833 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(539,820 |
) |
|
|
(539,820 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
700 |
|
|
|
20,000 |
|
|
|
1,321,256 |
|
|
|
(1,224,380 |
) |
|
|
117,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock
|
|
|
|
|
|
|
27,100 |
|
|
|
1,019,416 |
|
|
|
|
|
|
|
1,046,516 |
|
|
Issuance of common stock and stock options for services
|
|
|
|
|
|
|
100 |
|
|
|
1,087,650 |
|
|
|
|
|
|
|
1,087,750 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,805,380 |
) |
|
|
(1,805,380 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
$ |
700 |
|
|
$ |
47,200 |
|
|
$ |
3,428,322 |
|
|
$ |
(3,029,760 |
) |
|
$ |
446,462 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-5
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative period | |
|
|
|
|
from January 4, | |
|
|
For the Years Ended December 31, | |
|
2002 (date of | |
|
|
| |
|
inception) through | |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
December 31, 2005 | |
|
|
| |
|
| |
|
| |
|
| |
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(1,805,380 |
) |
|
$ |
(539,820 |
) |
|
$ |
(428,615 |
) |
|
$ |
(3,029,760 |
) |
Reconciliation of net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
1,374 |
|
|
|
366 |
|
|
|
|
|
|
|
1,740 |
|
|
Stock-based compensation
|
|
|
1,172,750 |
|
|
|
294,833 |
|
|
|
95,733 |
|
|
|
1,659,249 |
|
|
(Increase) in other prepaid expenses and deposits
|
|
|
(14,292 |
) |
|
|
|
|
|
|
|
|
|
|
(14,292 |
) |
|
(Decrease) increase in Accounts Payable
|
|
|
37,019 |
|
|
|
14,436 |
|
|
|
(50,403 |
) |
|
|
67,752 |
|
|
Increase (decrease) in accrued expenses
|
|
|
153,169 |
|
|
|
(335 |
) |
|
|
17,501 |
|
|
|
170,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(455,360 |
) |
|
|
(230,520 |
) |
|
|
(365,784 |
) |
|
|
(1,145,075 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital Expenditures
|
|
|
(3,940 |
) |
|
|
(1,831 |
) |
|
|
|
|
|
|
(5,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(3,940 |
) |
|
|
(1,831 |
) |
|
|
|
|
|
|
(5,771 |
) |
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
1,046,516 |
|
|
|
|
|
|
|
4,500 |
|
|
|
1,151,516 |
|
Proceeds from issuance of preferred stock
|
|
|
|
|
|
|
|
|
|
|
670,457 |
|
|
|
670,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
1,046,516 |
|
|
|
|
|
|
|
674,957 |
|
|
|
1,821,973 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
587,216 |
|
|
|
(232,351 |
) |
|
|
309,173 |
|
|
|
671,127 |
|
Cash and cash equivalents beginning of period
|
|
|
183,911 |
|
|
|
416,262 |
|
|
|
107,089 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents end of period
|
|
$ |
771,127 |
|
|
$ |
183,911 |
|
|
$ |
416,262 |
|
|
$ |
771,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for interest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash financing activities:
In 2005, 2004, 2003, and during the period from January 4,
2002 (date of inception) through December 31, 2005, the
Company recorded compensation expense of $1,067,750, $294,833,
$75,833 and $1,514,249, respectively, related to the issuance of
stock options to non-employees.
The accompanying notes are an integral part of these financial
statements.
F-6
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
NOTES TO FINANCIAL STATEMENTS
|
|
1. |
Organization and Description of Business |
Catalyst Pharmaceutical Partners, Inc. (the
Company) is a development-stage specialty
pharmaceutical company focused on the acquisition, development
and commercialization of prescription drugs for the treatment of
drug addiction. The Company was incorporated in the State of
Florida on January 4, 2002.
The Company has incurred operating losses in each period from
inception through December 31, 2005. The Company has been
able to fund its cash needs to date through an initial funding
from its founders and four subsequent private placements. The
Companys management intends to raise additional equity
funds though an initial public offering of its equity securities.
|
|
2. |
Basis of Presentation and Significant Accounting Policies |
|
|
|
|
a. |
DEVELOPMENT STAGE COMPANY. Since inception, the Company
has devoted substantially all of its efforts to business
planning, research and development, recruiting management and
technical staff, acquiring operating assets and raising capital.
Accordingly, the Company is considered to be in the development
stage and the Companys financial statements are presented
in accordance with Statement of Financial Accounting Standards
No. 7, Accounting and Reporting by Development Stage
Enterprises. The Companys primary focus is on the
chemical compound gamma-vinyl-GABA, commonly referred to as
vigabatrin as a potential treatment for addictions. |
|
|
b. |
USE OF ESTIMATES. The preparation of financial statements
in conformity with U.S. generally accepted accounting principles
requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those
estimates. |
|
|
c. |
CASH AND CASH EQUIVALENTS. The Company considers all
highly liquid instruments purchased with an original maturity of
three months or less to be cash equivalents. The Company has
substantially all of its cash and cash equivalents deposited
with one financial institution. |
|
|
d. |
PROPERTY AND EQUIPMENT. Property and equipment are stated
at cost, less accumulated depreciation and amortization.
Depreciation is computed using the straight-line method over the
estimated useful lives of the respective assets, generally three
to seven years. |
|
|
e. |
RESEARCH AND DEVELOPMENT. Costs incurred in connection
with research and development activities are expensed as
incurred. These costs consist of direct and indirect costs
associated with specific projects as well as fees paid to
various entities that perform research for the Company. Total
research and development expenses were $1,462,889, $378,254, and
$268,829 in 2005, 2004, and 2003, respectively. |
|
|
f. |
LICENSES AND OTHER PURCHASED PRODUCT RIGHTS. The costs of
acquired licenses and other purchased product rights are
capitalized and amortized over their respective useful lives,
generally the actual life of the license agreement. The
Financial Accounting Standards Board (FASB) has
issued Statement of Financial Accounting Standards
(SFAS) No. 142, Goodwill and Other
Intangible Assets (SFAS 142). The
provisions of SFAS 142 provide that the carrying value of
intangible assets that have finite useful lives are to be
amortized over their respected useful lives. |
F-7
|
|
|
|
g. |
STOCK BASED COMPENSATION. The Company has recognized in
the income statement the costs related to employee/consultant
services in share-based payment transactions by using the
estimated fair value of the stock at the date of grant, in
accordance with Statement of Financial Accounting Standards
(SFAS) No. 123, Accounting for Stock-Based
Compensation (SFAS 123). |
|
|
|
The Company accounts for the issuance of employee stock options
using the intrinsic value method. Accordingly, compensation cost
for stock options issued is measured as the excess, if any, of
the fair value of the Companys common stock at the date of
grant over the exercise price of the options. In 2005, 2004,
2003 and during the period from January 4, 2002 (date of
inception) through December 31, 2005, the Company recorded
compensation expense of $1,067,750, $294,833, $75,833 and
$1,514,249, respectively, related to the issuance of stock
options to nonemployees. The weighted average fair value of the
stock options granted in 2005, 2004 and during the period from
January 4, 2002 (date of inception) through
December 31, 2005 was $1.66, $1.46 and $1.44, respectively.
There were no stock options granted in 2003. The fair values
were determined using the Black-Scholes option-pricing model
with an estimated annual volatility of 100% for all periods,
expected holding periods of five to ten years, and a risk-free
interest rate of 5% in all periods through 2004 and a risk free
rate of 5.5% in 2005. |
|
|
|
|
h. |
DEFERRED COMPENSATION. The Company has an agreement with
one of the executive officers to defer payment of a portion of
his compensation due to him until the Company has completed an
equity financing raising gross proceeds of at least
$2.0 million. This contingency was satisfied at the closing
of the recently completed private placement (See Note 10)
and the full amount due to this executive officer for services
has been recognized in the income statement for each period for
which compensation was accrued subject to the contingency (See
Note 7). |
|
|
i. |
CONCENTRATION OF CREDIT RISK. The financial instrument
that potentially subjects the Company to concentration of credit
risk is cash. The Company places its cash with high-credit
quality financial institutions. |
|
|
j. |
INCOME TAXES. The Company utilizes the asset and
liability method of accounting for income taxes. Under this
method, deferred tax assets and liabilities are determined based
on differences between financial reporting and tax bases of
assets and liabilities and are measured using enacted tax rates
and laws that will be in effect when the differences are
expected to reverse. A valuation allowance is provided when it
is more likely than not that some portion or all of a deferred
tax asset will not be realized. |
|
|
k. |
EARNINGS (LOSS) PER SHARE. Basic earnings (loss) per
share is computed by dividing net earnings (loss) for the period
by the weighted average number of common shares outstanding
during the period. Diluted earnings (loss) per share is computed
by dividing net earnings (loss) for the period by the weighted
average number of common shares outstanding during the period,
plus the dilutive effect of common stock equivalents, such as
convertible preferred stock and stock options. For all periods
presented, all common stock equivalents were excluded because
their inclusion would have been anti-dilutive. Potentially
dilutive common stock equivalents as of December 31, 2005
include 70,000 shares of Series A Preferred Stock
convertible into 700,000 shares of common stock as well as stock
options to purchase up to 1,500,000 shares of common stock at
exercise prices ranging from $1.00 to $4.35. In addition, on
July 24, 2006, the Company completed a private placement of
7,644 shares of Series B preferred stock convertible into
764,400 shares of common stock. |
|
|
|
|
l. |
NEW ACCOUNTING PRONOUNCEMENTS. In December 2004, the FASB
issued Statement 123(R) which addresses the accounting for
share-based payment transactions (for example, stock options and
awards of restricted stock) in which an employer receives
employee- |
F-8
|
|
|
|
|
services in exchange for equity securities of the company or
liabilities that are based on a fair value of the companys
equity securities. This proposal eliminates use of APB Opinion
No. 25, Accounting for Stock Issued to Employees, and
requires such transactions to be accounted for using a fair
value-based method and recording compensation expense rather
than optional pro forma disclosure. The new standard
substantially amends SFAS 123. Statement 123(R) is
effective on January 1, 2006 and will require the Company
to recognize an expense for the fair value of its unvested
outstanding stock options in future financial statements. The
Company had no unvested stock options to employees as of January
1, 2006. |
|
|
|
In May 2005, the FASB issued SFAS No. 154,
Accounting Changes and Error Corrections, which
changes the requirements for the accounting and reporting of a
change in accounting principle. SFAS No. 154 applies to all
voluntary changes in accounting principle as well as to changes
required by an accounting pronouncement that does not include
specific transition provisions. SFAS No. 154 requires
that changes in accounting principle be retrospectively applied.
SFAS No. 154 is effective for accounting changes and
corrections of errors made in fiscal years beginning after
December 15, 2005. The Company does not expect the adoption of
this standard to have a material effect on the Companys
financial statements. |
|
|
A variety of proposed or otherwise potential accounting
standards are currently under study by standard-setting
organizations and various regulatory agencies. Because of the
tentative and preliminary nature of these proposed standards,
management has not determined whether implementation of such
proposed standards would be material to our condensed
consolidated financial statements. |
|
|
3. |
Property and Equipment |
Property and equipment, net consists of the following as of
December 31:
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Computer equipment
|
|
$ |
3,303 |
|
|
$ |
1,831 |
|
Furniture and equipment
|
|
|
2,468 |
|
|
|
|
|
Accumulated depreciation
|
|
|
(1,740 |
) |
|
|
(366 |
) |
|
|
|
|
|
|
|
|
Total property and equipment
|
|
$ |
4,031 |
|
|
$ |
1,465 |
|
|
|
|
|
|
|
|
The Company has executed a noncancellable operating lease
agreement for its corporate office. As of December 31,
2005, future minimum lease payments under the noncancellable
operating lease agreement are as follows:
|
|
|
|
|
2006
|
|
$ |
17,736 |
|
2007
|
|
|
18,268 |
|
2008
|
|
|
6,149 |
|
|
|
|
|
|
|
$ |
42,153 |
|
|
|
|
|
Rent expense was $16,041, $10,914, and $0 as of
December 31, 2005, 2004 and 2003, respectively.
F-9
Accrued expenses consist of the following as of December 31:
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
Common stock payable
|
|
$ |
105,000 |
|
|
$ |
20,000 |
|
Deferred payroll
|
|
|
83,327 |
|
|
|
|
|
Accrued license fee
|
|
|
69,352 |
|
|
|
|
|
Accrued professional fees
|
|
|
15,000 |
|
|
|
15,000 |
|
Other
|
|
|
2,556 |
|
|
|
2,066 |
|
|
|
|
|
|
|
|
|
|
$ |
275,235 |
|
|
$ |
37,066 |
|
|
|
|
|
|
|
|
|
|
|
|
a. |
LICENSE AGREEMENT WITH BROOKHAVEN. The Company has
entered into a license agreement with Brookhaven Science
Associates, LLC, as operator of Brookhaven National Laboratory
under contract with the United States Department of Energy
(Brookhaven), whereby the Company has obtained an
exclusive license for several patents and patent applications in
the U.S. and outside the U.S. relating to the use of vigabatrin
as a treatment for cocaine and other addictions. This license
agreement runs concurrently with the term of the last to expire
of the licensed patents, the last of which currently expires in
2020. The Company paid a fee to obtain the license in the amount
of $50,000. In addition the Company is required to reimburse
Brookhaven for the costs they have incurred relative to the
related patents. The amount of costs incurred prior to
September 30, 2005 is $69,352, which will become payable in
six monthly installments at the time the Company submits a new
drug application (NDA) to the U.S. Food and Drug
Administration (FDA). Costs incurred after
September 30, 2005 will also be due after the submission of
the NDA. The license agreement also calls for annual royalty
payments of $100,000 in the year of FDA approval of an NDA
relating to the licensed patents, $250,000 in the second and
third year after the approval and $500,000 for each subsequent
year until the expiration of the license agreement. The Company
also has the right to enter into sub-license agreements, and if
it does, a royalty of 20% of any sub-license fees will be
payable to Brookhaven. |
|
|
b. |
AGREEMENT WITH PHARMACEUTICS INTERNATIONAL, INC. The
Company has entered into an agreement with Pharmaceutics
International, Inc. (PII) under which PII will
develop for the Company its version of vigabatrin for use by the
Company in its clinical trials. The gross minimum costs related
to this agreement are estimated at $513,200. PII will progress
bill under this agreement pursuant to a schedule of payments to
run concurrent with the work they will be performing. The
payments will be due 30 days from the time of invoicing of
the schedule procedure. It is anticipated that this contract
will run over the next three years. |
In January 2005, the Company entered into an agreement with
Patrick McEnany, to act as the Companys Chief Executive
Officer. The agreement calls for an annual salary of $100,000
per year to commence as of March 1, 2005. The agreement
stipulates that half of Mr. McEnanys salary is to be
deferred until the Company raises equity in the amount of not
less than $2,000,000. Mr. McEnany has also deferred the
other half of his compensation until the equity minimum has been
met. As of December 31, 2005 and 2004, the amount payable
to Mr. McEnany for his deferred compensation was $83,327
and $0, respectively. All deferred compensation was earned and
paid to Mr. McEnany from the proceeds of the recently
completed private placement. (See Note 13.)
F-10
|
|
8. |
Related Party Transactions |
Since its inception in 2002, the Company has entered into
various Consulting Agreements with nonemployee officers and a
member of the Companys Scientific Advisory Board, a
portion of which were with related parties under common
ownership and control. During the years ended December 31,
2005 and 2004, the Company paid approximately $203,000 and
$15,000 in consulting fees to related parties. There were no
consulting fees paid to related parties for the year ended
December 31, 2003. In addition, as of December 31,
2005, the Company accrued $105,000 related to common stock
payable under certain consulting agreements. A fair value of $2
per share was used to determine the related expense in 2004 and
2005. This fair value was based on an internal valuation
performed by Company management based on the fair value of
similar entities and current market conditions. An aggregate of
52,500 shares of common stock were issued in July 2006 related
to this accrual. In addition, an additional 45,000 shares of
common stock were issued in July 2006 for services performed
from January 1, 2006 through June 30, 2006.
The Companys consulting agreement with its CFO requires a
bonus payment of approximately $150,000 upon the Companys
completion of a U.S. initial public offering of at least
$10 million.
Through July 2006, the Company did not have a formal stock
option plan.
On July 1, 2002, the Company entered into two
Non-Qualified Stock Option Agreements with the
Companys founders, Hubert Huckel and Patrick McEnany.
These agreements provided an option to purchase 250,000 shares
of the Companys common stock (500,000 shares in the
aggregate) at an exercise price of $1.00 per share. These
options expire ten years from their date of grant and previously
vested over three years.
On October 1, 2004, the Company entered into an agreement
with Jack Weinstein, a consultant to the Company. Pursuant to
this agreement, Mr. Weinstein received an option to purchase
150,000 shares of the Companys common stock. The exercise
price of 100,000 of these options is $2.00 per share. The
exercise price of the remaining 50,000 options is the offering
price of the next private placement to raise more than
$2 million ($4.35 based on the private placement that
closed on July 24, 2006). Of these 150,000 options, 50,000
vested immediately, 50,000 vested on October 1, 2005 and
50,000 vested upon completion of the July 2006 private
placement. These options expire five years from their date of
grant.
On January 3, 2005, the Company entered into a
Non-Qualified Stock Option Agreement with Charles
OKeeffe. This agreement included the right to purchase
200,000 shares of the Companys common stock at an exercise
price of $2.00 per share. These options vested immediately and
expire five years from their date of grant.
On March 4, 2005, the Company entered into two
Non-Qualified Stock Option Agreements with Hubert
Huckel and Patrick McEnany. These agreements provided an option
to purchase 250,000 shares of the Companys common stock
(500,000 shares in the aggregate ) at an exercise price of $1.00
per share. These options vested immediately and expire ten years
from their date of grant.
On March 4, 2005, an additional Non-Qualified Stock
Option Agreement was entered into with Jack Weinstein, a
consultant to the Company. This agreement provided an option to
purchase 150,000 shares of the Companys common stock. The
exercise price of 100,000 of these options is $2.00 per share.
The exercise price of the remaining 50,000 options is the
offering price of the next private placement to raise more than
$2 million ($4.35 based on the private placement that
closed on July 24, 2006). 100,000 of these options vested
immediately and the remaining vested upon the completion of the
July 2006 private placement. These options expire five years
from their date of grant.
F-11
In July 2006, the Company granted five-year options to purchase
100,000 shares of the Companys common stock to
M. Douglas Winship, its Vice President of Regulatory
Operations. These options vest over four-years and are
exercisable at an exercise price of $4.35 per share. These
options expire five years from their date of grant.
A summary of the Companys stock option activity and
related information for the years ended December 31, 2005,
2004, and 2003:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
|
|
|
Weighted-Average | |
|
|
|
Weighted Average | |
|
|
|
Weighted Average | |
|
|
Number of Options | |
|
Exercise Price | |
|
Number of Options | |
|
Exercise Price | |
|
Number of Options | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Outstanding at beginning of year
|
|
|
650,000 |
|
|
$ |
1.41 |
|
|
|
500,000 |
|
|
$ |
1.00 |
|
|
|
500,000 |
|
|
$ |
1.00 |
|
Granted
|
|
|
850,000 |
|
|
|
1.55 |
|
|
|
150,000 |
|
|
|
2.78 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at end of year
|
|
|
1,500,000 |
|
|
$ |
1.49 |
|
|
|
650,000 |
|
|
$ |
1.41 |
|
|
|
500,000 |
|
|
$ |
1.00 |
|
Exercisable at end of year
|
|
|
1,400,000 |
|
|
$ |
1.29 |
|
|
|
433,333 |
|
|
$ |
1.23 |
|
|
|
166,667 |
|
|
$ |
1.00 |
|
The following information applies to options outstanding at
December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
|
|
|
|
|
| |
|
|
|
Options Exercisable | |
|
|
|
|
Weighted-Average | |
|
|
|
| |
|
|
|
|
Remaining | |
|
Weighted Average | |
|
|
|
Weighted Average | |
Range of Exercise Prices |
|
Shares | |
|
Contractual Life | |
|
Exercise Price | |
|
Shares | |
|
Exercise Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$1.00 $2.00
|
|
|
1,400,000 |
|
|
|
8.57 years |
|
|
$ |
1.29 |
|
|
|
1,400,000 |
|
|
$ |
1.29 |
|
$4.35
|
|
|
100,000 |
|
|
|
5 years |
|
|
$ |
4.35 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,500,000 |
|
|
|
|
|
|
|
|
|
|
|
1,400,000 |
|
|
|
|
|
In November 2002, the Company completed a private placement in
which it raised gross proceeds of $125,000 through the sale of
500,000 shares of its common stock.
In April 2003, the Company completed a private placement in
which it raised net proceeds of $670,457 through the sale of
70,000 shares of its Series A Preferred Stock.
In March 2005, the Company completed a private placement in
which it raised net proceeds of $1,046,516 through the sale of
2,710,000 shares of the Companys common stock.
|
|
|
|
a. |
COMMON STOCK. The Company has 30,000,000 shares of
authorized common stock with a par value of $0.01 per share. At
December 31, 2005 and 2004, 4,720,000 and 2,000,000 shares,
respectively, of common stock were issued and outstanding. Each
holder of common stock is entitled to one vote of each share of
common stock held of record on all matters on which stockholders
generally are entitled to vote. |
|
|
b. |
PREFERRED STOCK. The Company has 5,000,000 shares of
authorized preferred stock outstanding, $0.01 par value per
share. |
|
|
|
|
i. |
Series A Preferred Stock. At December 31, 2005,
the Company had 70,000 shares of Series A Preferred Stock
issued and outstanding. Each share of outstanding Series A
Preferred Stock has a liquidation preference of $1.00 per share
and votes with the Common Stock on the basis of ten votes for
each share of Series A Preferred Stock outstanding. Each
share of Series A |
F-12
|
|
|
|
|
Preferred Stock is convertible, at the option of the holder,
into ten shares of common stock; provided, however, that all of
the outstanding shares of Series A Preferred Stock will
automatically convert into shares of the Companys Common
Stock under certain circumstances, including the completion of
an initial public offering. |
As of December 31, 2005 and 2004 the Company had deferred
tax assets of approximately $1,151,000 and $465,000,
respectively, of which approximately $576,000 and $296,000
represent net operating loss carryforwards. The remaining
deferred tax assets represent nondeductible stock option
expense. The related deferred tax asset has a 100% valuation
allowance as of December 31, 2005 and 2004, as the Company
believes it is more likely than not that the deferred tax asset
will not be realized. The change in valuation allowance was
approximately $686,000, $205,000 and $163,000 in 2005, 2004, and
2003, respectively. There are no other significant temporary
differences. The net operating loss carry-forwards will expire
at various dates beginning in 2022 and expiring in 2025. If an
ownership change, as defined under Internal Revenue Code
Section 382, occurs, the use of these carry-forwards may be
subject to limitation.
The effective tax rate of 0% in all periods presented differs
from the statutory rate of 35% due to the valuation allowance.
|
|
|
|
a. |
PRIVATE PLACEMENT. On July 24, 2006, the Company
completed a private placement in which it raised net proceeds of
$3,225,140 through the sale of 7,644 shares of the
Companys Series B Preferred Stock. Each share of
outstanding Series B Preferred Stock has a liquidation
preference of $435 per share and votes with the Common Stock on
the basis of 100 votes for each share of Series B Preferred
Stock outstanding. Each share of Series B Preferred Stock
is convertible, at the option of the holder, into 100 shares of
common stock; provided, however, that all of the outstanding
shares of Series B Preferred Stock will automatically
convert into shares of common stock under certain circumstances,
including the completion of an initial public offering. |
|
|
b. |
2006 STOCK INCENTIVE PLAN. In July 2006 the Company
adopted the 2006 Stock Incentive Plan (the Plan).
The Plan provides for the Company to issue options, restricted
stock, stock appreciation rights and restricted stock units
(collectively, the Awards) to employees, directors
and consultants of the Company. Under the Plan, 1,500,000 shares
of the Companys Common Stock have been reserved for
issuance. No grants have been made to date under the Plan. |
F-13
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
December 31, | |
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
|
|
(unaudited) | |
|
|
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
324,154 |
|
|
$ |
771,127 |
|
|
Prepaid insurance
|
|
|
2,681 |
|
|
|
440 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
326,835 |
|
|
|
771,567 |
|
|
Property and equipment, net
|
|
|
14,426 |
|
|
|
4,031 |
|
|
Deposits
|
|
|
23,852 |
|
|
|
13,852 |
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$ |
365,113 |
|
|
$ |
789,450 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
24,946 |
|
|
$ |
67,753 |
|
|
Accrued expenses
|
|
|
409,405 |
|
|
|
275,235 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
434,351 |
|
|
|
342,988 |
|
|
|
|
|
|
|
|
Commitments and Contingencies (See notes)
|
|
|
|
|
|
|
|
|
Stockholders equity (deficit)
|
|
|
|
|
|
|
|
|
|
Preferred stock, $.01 par value, 5,000,000 shares authorized,
70,000 shares Series A Preferred Stock outstanding
|
|
|
700 |
|
|
|
700 |
|
|
Common stock, $.01 par value, 30,000,000 shares authorized,
4,720,000 shares issued and outstanding at June 30, 2006
and December 31, 2005
|
|
|
47,200 |
|
|
|
47,200 |
|
|
Additional paid-in capital
|
|
|
3,579,447 |
|
|
|
3,428,322 |
|
|
Accumulated deficit
|
|
|
(3,696,585 |
) |
|
|
(3,029,760 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity (deficit)
|
|
|
(69,238 |
) |
|
|
446,462 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity (deficit)
|
|
$ |
365,113 |
|
|
$ |
789,450 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these interim
financial statements.
F-14
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative Period | |
|
|
For the Six Months Ended | |
|
from January 4, | |
|
|
June 30, | |
|
2002 (date of | |
|
|
| |
|
inception) to June | |
|
|
2006 | |
|
2005 | |
|
30, 2006 | |
|
|
| |
|
| |
|
| |
|
|
(unaudited) | |
|
(unaudited) | |
Revenues
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
191,639 |
|
|
|
187,394 |
|
|
|
800,042 |
|
|
General and administrative
|
|
|
242,194 |
|
|
|
126,811 |
|
|
|
1,049,925 |
|
|
Non-cash compensation
|
|
|
241,125 |
|
|
|
1,013,375 |
|
|
|
1,880,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
674,958 |
|
|
|
1,327,580 |
|
|
|
3,730,341 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(674,958 |
) |
|
|
(1,327,580 |
) |
|
|
(3,730,341 |
) |
Interest income
|
|
|
8,133 |
|
|
|
5,908 |
|
|
|
33,756 |
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(666,825 |
) |
|
|
(1,321,672 |
) |
|
|
(3,696,585 |
) |
Provision for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(666,825 |
) |
|
$ |
(1,321,672 |
) |
|
$ |
(3,696,585 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share basic and diluted
|
|
$ |
(0.14 |
) |
|
$ |
(0.35 |
) |
|
|
|
|
Weighted average shares outstanding basic and diluted
|
|
|
4,720,000 |
|
|
|
3,767,033 |
|
|
|
|
|
The accompanying notes are an integral part of these interim
financial statements.
F-15
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENT OF STOCKHOLDERS EQUITY (DEFICIT)
(unaudited)
For the six months ended June 30, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
|
|
During the | |
|
|
|
|
|
|
|
|
|
|
Development | |
|
|
|
|
Preferred Stock | |
|
Common Stock | |
|
Paid-in Capital | |
|
Stage | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Balance at December 31, 2005
|
|
$ |
700 |
|
|
$ |
47,200 |
|
|
$ |
3,428,322 |
|
|
$ |
(3,029,760 |
) |
|
$ |
446,462 |
|
|
Issuance of stock options for services
|
|
|
|
|
|
|
|
|
|
|
151,125 |
|
|
|
|
|
|
|
151,125 |
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(666,825 |
) |
|
|
(666,825 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006
|
|
$ |
700 |
|
|
$ |
47,200 |
|
|
$ |
3,579,447 |
|
|
$ |
(3,696,585 |
) |
|
$ |
(69,238 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these interim
financial statements.
F-16
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative period | |
|
|
|
|
from January 4, | |
|
|
For the Six Months Ended June | |
|
2002 (date of | |
|
|
30, | |
|
inception) through | |
|
|
| |
|
June 30, | |
|
|
2006 | |
|
2005 | |
|
2006 | |
|
|
| |
|
| |
|
| |
|
|
(unaudited) | |
|
(unaudited) | |
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(666,825 |
) |
|
$ |
(1,321,672 |
) |
|
$ |
(3,696,585 |
) |
Reconciliation of net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
2,051 |
|
|
|
687 |
|
|
|
3,791 |
|
|
Stock-based compensation
|
|
|
241,125 |
|
|
|
1,013,374 |
|
|
|
1,900,374 |
|
|
(Increase) in other prepaid expenses and deposits
|
|
|
(12,241 |
) |
|
|
(16,100 |
) |
|
|
(26,533 |
) |
|
(Decrease) increase in accounts payable
|
|
|
(42,806 |
) |
|
|
90 |
|
|
|
24,946 |
|
|
Increase (decrease) in accrued expenses
|
|
|
44,169 |
|
|
|
79,510 |
|
|
|
214,406 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(434,527 |
) |
|
|
(244,111 |
) |
|
|
(1,579,601 |
) |
|
|
|
|
|
|
|
|
|
|
Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(12,446 |
) |
|
|
(3,940 |
) |
|
|
(18,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(12,446 |
) |
|
|
(3,940 |
) |
|
|
(18,218 |
) |
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
|
|
|
|
1,046,516 |
|
|
|
1,151,516 |
|
Proceeds from issuance of preferred stock
|
|
|
|
|
|
|
|
|
|
|
670,457 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
|
|
|
|
1,046,516 |
|
|
|
1,821,973 |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
(446,973 |
) |
|
|
798,465 |
|
|
|
224,154 |
|
Cash and cash equivalents January 1
|
|
|
771,127 |
|
|
|
183,911 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents June 30
|
|
$ |
324,154 |
|
|
$ |
982,376 |
|
|
$ |
324,154 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for interest
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash financing activities:
During the six months ended June 30, 2006 and 2005, the
Company recorded compensation expense of $151,125 and $998,375,
respectively, related to the issuance of stock options to
nonemployees.
The accompanying notes are an integral part of these interim
financial statements.
F-17
CATALYST PHARMACEUTICAL PARTNERS, INC.
(a development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
|
|
1. |
Organization and Description of Business |
Catalyst Pharmaceutical Partners, Inc. (Company) is
a development-stage specialty pharmaceutical company focused on
the acquisition, development and commercialization of
prescription drugs for the treatment of drug addiction. The
Company was incorporated in the State of Florida on
January 4, 2002.
The Company has incurred operating losses in each period from
inception through June 30, 2006. The Company has been able
to fund its cash needs to date through an initial funding from
its founders and four subsequent private placements. The
Companys management intends to raise additional equity
funds though an initial public offering of its equity securities.
|
|
2. |
Basis of Presentation and Significant Accounting Policies |
|
|
|
|
a. |
DEVELOPMENT STAGE COMPANY. Since inception, the Company
has devoted substantially all of its efforts to business
planning, research and development, recruiting management and
technical staff, acquiring operating assets and raising capital.
Accordingly, the Company is considered to be in the development
stage and the Companys financial statements are presented
in accordance with Statement of Financial Accounting Standards
No. 7, Accounting and Reporting by Development Stage
Enterprises. |
|
|
b. |
INTERIM FINANCIAL STATEMENTS. The accompanying unaudited
interim condensed financial statements have been prepared
pursuant to the rules and regulations of the Securities and
Exchange Commission for reporting of interim financial
information. Pursuant to such rules and regulations, certain
information and footnote disclosures normally included in
financial statements prepared in accordance with accounting
principles generally accepted in the United States have been
condensed or omitted. The accompanying unaudited interim
condensed financial statements should be read in conjunction
with the Companys audited financial statements and the
notes thereto included elsewhere in this prospectus. |
|
|
|
In the opinion of management, the accompanying unaudited interim
condensed financial statements of the Company contain all
adjustments (consisting of only normal recurring adjustments)
necessary to present fairly the financial position of the
Company as of June 30, 2006, the results of its operations
for the six month periods ended June 30, 2006 and 2005 and
its cash flows for the six month periods ended June 30,
2006 and 2005. The results of operations and cash flows for the
six month period ended June 30, 2006 are not necessarily
indicative of the results of operations or cash flows which may
be reported for the year ending December 31, 2006. |
|
|
|
|
c. |
USE OF ESTIMATES. The preparation of financial statements
in conformity with U.S. generally accepted accounting principles
requires management to make estimates and assumptions that
affect the amounts reported in the financial statements and
accompanying notes. Actual results could differ from those
estimates. |
F-18
|
|
3. |
Property and Equipment |
Property and equipment, net consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
December 31, | |
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
Computer equipment
|
|
$ |
11,715 |
|
|
$ |
3,303 |
|
Furniture and equipment
|
|
|
6,502 |
|
|
|
2,468 |
|
Accumulated depreciation
|
|
|
(3,791 |
) |
|
|
(1,740 |
) |
|
|
|
|
|
|
|
|
Total property and equipment
|
|
$ |
14,426 |
|
|
$ |
4,031 |
|
|
|
|
|
|
|
|
|
|
|
|
a. |
COMMON STOCK. The Company has 30,000,000 shares of
authorized common stock with a par value of $0.01 per share. At
June 30, 2006 and December 31, 2005, 4,720,000 shares,
respectively, of common stock were issued and outstanding. Each
holder of common stock is entitled to one vote of each share of
common stock held of record on all matters on which stockholders
generally are entitled to vote. |
|
|
b. |
PREFERRED STOCK. The Company has 5,000,000 shares of
authorized preferred stock outstanding, $0.01 par value per
share. |
|
|
|
|
i. |
Series A Preferred Stock. At December 31, 2005,
the Company had 70,000 shares of Series A Preferred Stock
outstanding. Each share of outstanding Series A Preferred
Stock has a liquidation preference of $1.00 per share and votes
with the Common Stock on the basis of ten votes for each share
of Series A Preferred Stock outstanding. Each share of
Series A Preferred Stock is convertible, at the option of
the holder, into ten shares of common stock; provided, however,
that all of the outstanding shares of Series A Preferred
Stock will automatically convert into shares of the
Companys Common Stock under certain circumstances,
including the completion of an initial public offering. |
|
|
5. |
Related Party Transactions. |
Since its inception in 2002, the Company has entered into
various Consulting Agreements with non-employee officers, and a
member of the Companys Scientific Advisory Board, a
portion of which were with related parties under common
ownership and control. During the six months ended June 30,
2006 and 2005, the Company paid approximately $65,000 and
$93,000 in consulting fees to related parties. In addition, as
of June 30, 2006, the Company accrued $195,000 related to
common stock payable under certain consulting arrangements. A
fair value of $4.35 per share was used to determine the related
expense for the six months ended June 30, 2006. This fair
value was based on an internal valuation performed by Company
management based on the fair value of similar entities and
current market conditions. An aggregate of 45,000 shares of
common stock were issued in July 2006 related to this accrual.
The Companys consulting agreement with its CFO requires a
bonus payment of approximately $150,000 upon the completion of a
U.S. initial public offering of at least $10 million.
|
|
|
|
a. |
PRIVATE PLACEMENT. On July 24, 2006, the Company
completed a private placement in which it raised net proceeds of
$3,225,140 through the sale of 7,644 shares of the
Companys Series B Preferred Stock. Each share of
outstanding Series B Preferred Stock has a liquidation
preference of $435 per share and votes with the Common Stock on
the basis of 100 votes for each |
F-19
|
|
|
|
|
share of Series B Preferred Stock outstanding. Each share
of Series B Preferred Stock is convertible, at the option
of the holder, into 100 shares of common stock; provided,
however, that all of the outstanding shares of Series B
Preferred Stock will automatically convert into shares of common
stock under certain circumstances, including the completion of
an initial public offering. |
|
|
b. |
2006 STOCK INCENTIVE PLAN. In July 2006 the Company
adopted the 2006 Stock Incentive Plan (the Plan).
The Plan provides for the Company to issue options, restricted
stock, stock appreciation rights and restricted stock units
(collectively, the Awards) to employees, directors
and consultants of the Company. Under the Plan, 1,500,000 shares
of the Companys common stock have been reserved for
issuance. No options have been granted to date under the Plan. |
F-20
Common Stock
Shares
|
|
First Albany Capital |
Stifel Nicolaus |
The date of this prospectus
is ,
2006
Through and
including ,
2006 (the 25th day after the date of this prospectus), all
dealers that effect transactions in our common stock, whether or
not participating in this offering, may be required to deliver a
prospectus. This delivery requirement is in addition to the
dealers obligation to deliver a prospectus when acting as
underwriters and with respect to their unsold allotments or
provisions.
PART II
Information Not Required In Prospectus
Item 13. Other Expenses of
Issuance and Distribution
The following table sets forth the various costs and expenses to
be incurred in connection with the issuance and distribution of
the securities registered under this Registration Statement,
other than underwriting discounts and commissions. All such
expenses are estimates, except for the SEC registration fee, the
NASD filing fee, and the Nasdaq Global Market listing fee. The
following expenses will be borne solely by the Registrant.
|
|
|
|
|
SEC Registration Fee
|
|
$ |
4,306.75 |
|
NASD Filing Fee
|
|
|
4,525.00 |
|
Nasdaq Global Market Listing Fee
|
|
|
* |
|
Printing and Engraving Expenses
|
|
|
* |
|
Legal Fees and Expenses
|
|
|
* |
|
Accounting Fees and Expenses
|
|
|
* |
|
Transfer Agent and Registrar Fees
|
|
|
* |
|
Miscellaneous Expenses
|
|
|
* |
|
|
|
|
|
Total
|
|
$ |
* |
|
* To be furnished by amendment.
Item 14. Indemnification of
Officers and Directors
Section 145 of the Delaware General Corporation Law
permits, in general, a Delaware corporation to indemnify any
person who was or is a party to any proceeding (other than an
action by, or in the right of, the corporation) by reason of the
fact that he or she is or was a director or officer of the
corporation, or served another business enterprise in any
capacity at the request of the corporation, against liability
incurred in connection with such proceeding, including the
estimated expenses of litigating the proceeding to conclusion
and the expenses actually and reasonably incurred in connection
with the defense or settlement of such proceeding, if such
person acted in good faith and in a manner he or she reasonably
believed to be in, or not opposed to, the best interests of the
corporation and, in criminal actions or proceedings,
additionally had no reasonable cause to believe that his or her
conduct was unlawful. A Delaware corporations power to
indemnify applies to actions brought by or in the right of the
corporation as well, but only to the extent of expenses
(including attorneys fees) actually and reasonably
incurred by the person in connection with the defense or
settlement of the action or suit, provided that no
indemnification shall be provided in such actions in the event
of any adjudication of negligence or misconduct in the
performance of such persons duties to the corporation,
unless a court believes that in light of all the circumstances
indemnification should apply. Section 145 of the Delaware
General Corporation Law also permits, in general, a Delaware
corporation to purchase and maintain insurance on behalf of any
person who is or was a director or officer of the corporation,
or served another entity in any capacity at the request of the
corporation, against liability incurred by such person in such
capacity, whether or not the corporation would have the power to
indemnify such person against such liability.
The Registrants By-Laws implement the indemnification
provisions permitted by Section 145 of the Delaware General
Corporation Law by providing that:
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The Registrant shall indemnify any person that was or is a party
to any proceeding by reason of the fact that he or she is or was
a director or an officer of the Registrant, to the fullest
extent permitted by the Delaware General Corporation Law. |
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The Registrant shall prepay expenses, including attorneys
fees, incurred by a director or an officer in connection with
defending a proceeding for which the Registrant is required to
provide indemnification, provided that the director or the
officer shall undertake to repay such advances if it is
ultimately determined that such person is not entitled to
indemnification for such expenses. |
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The Registrant shall pay a claim for indemnification or
advancement of expenses within 30 days after it receives a
written claim from an indemnified director or officer. Such
director or officer may file suit to recover the unpaid claim
amount, and the corporation shall have the burden of proving
that the director or officer is not entitled to the requested
claim amount. |
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The grant of indemnification rights by the registrant shall not
be exclusive of any other rights that an indemnified director or
officer may have or hereafter acquire under any statute,
agreement, vote of stockholders or disinterested directors, or
provision of the Certificate of Incorporation or the by-laws of
the Registrant. |
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The Registrants obligation, if any, to indemnify or to
advance expenses to any indemnified person who was or is serving
another corporation, partnership, joint venture, trust,
enterprise or non-profit enterprise shall be reduced by any
amount such employee may collect as indemnification or
advancement of expenses from the other corporation, partnership,
joint venture, trust, enterprise or non-profit enterprise. |
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The Registrant may, in its discretion, indemnify and advance
expenses to employees and agents, to the extent and manner
permitted by law, under circumstances where indemnification is
not required by law. |
In addition, as permitted by Section 102 of the Delaware
General Corporation Law, the Registrants Certificate of
Incorporation includes a provision that eliminates the personal
liability of its directors for monetary damages for breach of
their fiduciary duty as directors to the fullest extent
permitted by the Delaware General Corporation Law.
These indemnification provisions may be sufficiently broad to
permit indemnification of the Registrants directors and
officers for liabilities (including reimbursement of expenses
incurred) arising under the Securities Act. Pursuant to the
Underwriting Agreement to be filed as Exhibit 1.1 to this
Registration Statement, the underwriters have agreed to
indemnify the Registrants directors, officers, and
controlling persons, and the Registrant has agreed to indemnify
the underwriters, against certain civil liabilities that may be
incurred in connection with the offering of securities pursuant
to this Registration Statement (including certain liabilities
under the Securities Act) as a result of any statement or
omission in this Registration Statement, in the related
prospectus, in any preliminary prospectus, or in any amendment
or supplement thereto, in each case to the extent that the
statement or omission was made in reliance upon and in
conformity with written information furnished by the
underwriters expressly for use therein.
Item 15. Recent Sales of
Unregistered Securities
The following is information furnished with regard to all
securities sold by the Registrant within the past three years
that were not registered under the Act.
On February 28, 2005, the Registrant completed a rights
offering of shares of its authorized but unissued common stock
to holders of its common stock and holders of its Series A
Preferred Stock. In the rights offering, the Registrant issued
2,710,000 shares of its common stock to its stockholders. No
commissions were paid in connection with the issuance of the
foregoing shares, all of which were issued pursuant to an
exemption from registration under Section 4(2) of the Act.
This offering resulted in proceeds of approximately $1,000,000
to the Registrant, net of expenses.
On July 24, 2006, the Registrant completed the sale of
7,644 shares of its Series B Preferred Stock, par value
$0.01 per share at a price of $435 per share. The foregoing
securities were issued to 51 accredited investors and were
issued pursuant to an exemption from registration under
Section 4(2) of the Act.
II-2
In July 2006, the Registrant issued an aggregate of 97,500
shares of its common stock to five of its advisors for services
performed during 2004, 2005 and through June 30, 2006.
These shares were issued pursuant to an exemption from
registration under Section 4(2) of the Act.
None of these transactions involved any underwriters,
underwriting discounts, or any public offering. The recipients
of securities in each transaction represented their intention to
acquire the securities for investment only and not with a view
to or for sale in connection with any distribution thereof, and
appropriate legends were affixed to the stock certificates and
instruments issued in such transactions. All recipients received
adequate information regarding the Registrant and the stock sold.
Item 16. Exhibits and
Financial Statement Schedules
(a) Exhibits
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Exhibit |
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Number |
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Description of Exhibit |
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1 |
.1 |
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Underwriting Agreement dated as
of ,
2006 between Catalyst Pharmaceutical Partners, Inc. and the
underwriters named therein* |
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3 |
.1 |
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Certificate of Incorporation |
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3 |
.2 |
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Amendment to Certificate of Incorporation |
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3 |
.3 |
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By-laws |
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5 |
.1 |
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Opinion of Akerman Senterfitt* |
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10 |
.1 |
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Employment Agreement between the Company and Patrick J. McEnany* |
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10 |
.2 |
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Employment Agreement between the Company and Jack Weinstein* |
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10 |
.3 |
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License Agreement, as amended, between the Company and
Brookhaven National Laboratories |
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10 |
.4 |
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Stock Option Agreements between the Company and Patrick J.
McEnany |
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10 |
.5 |
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Stock Option Agreements between the Company and Hubert Huckel |
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10 |
.6 |
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Stock Option Agreements between the Company and Jack Weinstein |
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10 |
.7 |
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Stock Option Agreement between the Company and Charles
OKeeffe |
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10 |
.8 |
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2006 Stock Incentive Plan |
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23 |
.1 |
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Consent of Grant Thornton LLP |
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23 |
.2 |
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Consent of Akerman Senterfitt (included as Exhibit 5.1)* |
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24 |
.1 |
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Power of Attorney (included on Page II-5) |
* To be filed by amendment
(b) Financial Statement Schedules
None.
Item 17. Undertakings
(1) The undersigned registrant hereby undertakes to provide
to the underwriters at the closing specified in the Underwriting
Agreement certificates in such denominations and registered in
such names as required by the underwriters to permit prompt
delivery to each purchaser
(2) Insofar as indemnification for liabilities arising
under the Securities Act of 1933 may be permitted to directors,
officers, and controlling persons of the registrant pursuant to
the foregoing provisions, or otherwise, the registrant has been
advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as
expressed in the Act and is, therefore, unenforceable. In the
event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses
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incurred or paid by a director, officer, or a controlling person
of the registrant in the successful defense of any action, suit,
or proceeding) is asserted by such director, officer or
controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question
whether such indemnification by it is against public policy as
expressed in the Act and will be governed by the final
adjudication of such issue.
(3) The undersigned registrant hereby undertakes that:
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(a) |
For purposes of determining any liability under the Securities
Act of 1933, the information omitted from the form of the
prospectus filed as a part of this registration statement in
reliance upon Rule 430A and contained in a form of
prospectus filed by the registrant pursuant to
Rule 424(b)(1) or (4) or 497(h) under the Securities
Act shall be deemed to be a part of this registration statement
at the time it was declared effective. |
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(b) |
For the purpose of determining any liability under the
Securities Act of 1933, each post-effective amendment that
contains a form of prospectus shall be deemed to be a new
registration statement relating to the securities offered
therein, and the offering of such securities at that time shall
be deemed to be the initial bona fide offering thereof. |
II-4
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as
amended, the registrant has duly caused this registration
statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in City of Miami, State of Florida on
July 25, 2006.
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CATALYST PHARMACEUTICAL PARTNERS, INC. |
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By: |
/s/ Patrick J. McEnany |
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Patrick J. McEnany |
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President and Chief Executive Officer |
POWER OF ATTORNEY
Each person whose signature appears below hereby constitutes and
appoints Patrick J. McEnany and Jack Weinstein, and each of
them, as his true and lawful
attorneys-in-fact and
agents, with full power of substitution and resubstitution for
him and in his name, place, and stead, in any and all
capacities, to sign any or all amendments or supplements to this
registration statement, whether pre-effective or post-effective,
including any subsequent registration statement for the same
offering which may be filed under Rule 462(b) under the
Securities Act of 1933, as amended, to file the same with all
exhibits thereto and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, and each of them, full power and
authority to do and perform each and every act and thing
necessary or appropriate to be done with respect to this
registration statement or any amendments or supplements hereto
in the premises, as fully to all intents and purposes as he
might or could do in person, hereby ratifying and confirming
that all said
attorneys-in-fact and
agents, or any of them, or this or his substitute or
substitutes, may lawfully do or cause to be done by virtue
thereof.
Pursuant to the requirements of the Securities Act of 1933, this
registration statement has been signed by the following persons,
in the capacities and on the dates indicated.
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Signature |
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Title |
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Date |
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/s/ Patrick J. McEnany
Patrick
J. McEnany |
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Chairman of the Board of Directors, President and Chief
Executive Officer (Principal Executive Officer) |
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July 25, 2006 |
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/s/ Jack Weinstein
Jack
Weinstein |
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Vice President, Treasurer and
Chief Financial Officer (Principal Financial Officer) |
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July 25, 2006 |
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/s/ Hubert E. Huckel, M.D.
Hubert
E. Huckel, M.D. |
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Director |
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July 25, 2006 |
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/s/ Charles B. OKeeffe
Charles
B. OKeeffe |
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Director |
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July 25, 2006 |
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Signature |
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Title |
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Date |
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/s/ Philip H. Coelho
Philip
H. Coelho |
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Director |
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July 25, 2006 |
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/s/ David S. Tierney, M.D.
David
S. Tierney, M.D. |
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Director |
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July 25, 2006 |
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/s/ Milton J. Wallace
Milton
J. Wallace |
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Director |
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July 25, 2006 |
II-6
EXHIBIT 3.1 CERTIFCATE OF INCORPORATION
Exhibit 3.1
CERTIFICATE OF INCORPORATION
OF
CATALYST PHARMACEUTICAL PARTNERS, INC.
The undersigned Incorporator, for the purpose of forming a corporation under the laws of the
State of Delaware, hereby adopts the following Certificate of Incorporation:
ARTICLE I.
NAME
The name of the corporation is Catalyst Pharmaceutical Partners, Inc. (the Corporation)
ARTICLE II
REGISTERED OFFICE
The address of the registered office of the Corporation in the State of Delaware is 2711
Centerville Road, Suite 400, in the city of Wilmington, County of New Castle, State of Delaware
(zip code 19808). The name of its registered agent at such address is Corporation Service Company.
ARTICLE III
PURPOSES
The nature of the business or purposes to be conducted or promoted by the Corporation is to
engage in any lawful act or activity for which corporations may be organized under the General
Corporate Laws for the State of Delaware (DGCL)
ARTICLE IV
CAPITAL STOCK
The total number of shares of capital stock which the Corporation shall have the authority to
issue is 105,000,000, of which (i) 100,000,000 shares shall be Common Stock, par value $0.001 per
share (the Common Stock) and (ii) 5,000,000 shares shall be Preferred Stock, par value $0.001 per
share (the Preferred Stock).
The designations, powers, preferences and rights of, and the qualifications, limitations and
restrictions upon, each class or series of stock shall be determined in accordance with, or as set
forth below.
A. Common Stock
Section 1. General. Except as otherwise expressly provided, all shares of Common Stock
shall be identical and shall entitle the holders thereof to the same rights and privileges.
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Section 2. Voting. Each holder of record shall be entitled to one vote for each share
of Common Stock standing in his name on the books of the Corporation.
Section 3. Dividends. Subject to applicable law, the holders of shares of Common Stock
shall be entitled to receive dividends out of funds legally available therefor at such times and in
such amounts as the Board of Directors may determine in its sole discretion, with each share of
Common Stock sharing equally, share for share, in such dividends.
Section 4. Liquidation. Upon any liquidation, dissolution or winding up of the
Corporation, whether voluntary or involuntary (each, a Liquidation Event), after the payment or
provision for payment of all debts and liabilities of the Corporation and all preferential amounts
to which the holders of Preferred Stock are entitled with respect to the distribution of assets in
liquidation, the holders of Common Stock shall be entitled to share ratably in the remaining assets
of the Corporation entitled for distribution.
B. Preferred Stock
Subject to any limitations prescribed by law, the Board of Directors or any authorized
committee thereof is expressly authorized to provide for the issuance of shares of Preferred Stock
in one or more series of such stock, and by filing a certificate pursuant to applicable law in the
State of Delaware, to establish or change from time-to-time and fix the number of shares to be
included in each such series, and to fix the designations, powers, preferences and the relative,
participating, optional or other special rights of the shares of each series and any
qualifications, limitations and restrictions thereof. Any action by the Board of Directors or any
authorized committee thereof under this Article IV to fix the designations, powers, preferences and
the relative, participating, optional or other special rights of the shares of a series of
Preferred Stock and any qualifications, limitations and restrictions thereof shall require the
affirmative vote of the majority of the Directors then in office or a majority of the members of
such committee. The authority of the Board of Directors or any authorized committee thereof shall
include, but not be limited to, the right to determine or fix one or more of the following with
respect to each series of Preferred Stock to the extent permitted by law:
(a) The distinctive serial designation and the number of shares constituting such series;
(b) The dividend rates of the amount of dividends to be paid on the shares of such series,
whether dividends shall be cumulative, and, if so, from which date or dates, the payment date or
dates for dividends, and the participating and other rights, if any, with respect to dividends;
(c) The amounts payable on, and the preferences, if any, of the shares of the series in
respect of dividends, and whether such dividends, if any, shall be full or cumulative;
(d) The dates at which dividends, if any, shall be payable;
(e) The voting powers, full or limited, if any, of the shares of such series;
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(f) Whether the shares of such series shall be redeemable, and, if so, the price or prices at
which, and the terms and conditions on which, such shares may be redeemed;
(g) The amount or amounts payable upon the shares of such series and any preferences
applicable thereto in the event of voluntary or involuntary liquidation, dissolution or winding up
of the Corporation;
(h) Whether the shares of such series shall be entitled to the benefit of a sinking or
retirement fund to be applied to the purchase or redemption of such shares, and if so entitled, the
amount of such fund and the manner of its application, including the price or prices at which such
shares may be redeemed or purchased through the application of such fund;
(i) Whether the shares of such series shall be convertible into, or exchangeable for, shares
of any other class or classes or of any other series of the same or any other class or classes of
stock of the Corporation, and, if so convertible or exchangeable, the conversion price or prices,
or the rate or rates of exchange, and the adjustments thereof, if any, at which such conversion or
exchange may be made, and any other terms and conditions of such conversion or exchange;
(j) The price or other consideration for which the shares of such series shall be issued;
(k) Whether the shares of such series which are redeemed or converted shall have the status of
authorized but unissued shares of Preferred Stock (or series thereof) and whether such shares may
be reissued as shares of the same or any other class or series of stock; and
(l) Such other powers, preferences, rights, qualifications, limitations, and restrictions
thereof as the Board of Directors or any authorized committee thereof may deem advisable.
C. Rights
The Board of Directors is expressly authorized to create and issue rights (the Rights)
entitling the holders thereof to purchase from the Corporation shares of capital stock or other
securities. The times at which and the terms upon which the Rights are to be issued will be
determined by the Board of Directors and set forth in the contracts or instruments that evidence
the Rights. The authority of the Board of Directors with respect to the Rights shall include, but
not be limited to, determination of the following:
(a) The initial purchase price per share of the capital stock or other
securities of the Corporation to be purchased upon exercise of the Rights;
(b) Provisions relating to the times at which and the circumstances under which
the Rights may be exercised or sold or otherwise transferred, either together with
or separately from, any other securities of the Corporation;
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(c) Provisions that adjust the number or exercise price of the Rights or amount
or nature of the securities or other property receivable upon exercise of Rights in
the event of a combination, split or recapitalizations of any capital
stock of the Corporation, a change in ownership of the Corporations securities or a
reorganization, merger, consolidation, sale of assets or other occurrence relating
to the Corporation or any capital stock of the Corporation, and provisions
restricting the ability of the Corporation to enter into any such transaction absent
an assumption by the other party or parties thereto of the obligations of the
Corporation under such Rights;
(d) Provisions that deny the holder of a specified percentage of the
outstanding securities of the Corporation the right to exercise the Rights and/or
cause the Rights held by such holder to become void;
(e) Provisions that permit the Corporation to redeem the Rights; and
(f) The appointment of a Rights Agent with respect to the Rights;
and such other provisions relating to the Rights as may be determined by the Board of Directors.
ARTICLE V
INCORPORATOR
The incorporator of the Corporation is Philip B. Schwartz, whose mailing address is One
Southeast Third Avenue, Miami, Florida 33131.
ARTICLE VI
STOCKHOLDER ACTION
Any action required or permitted to be taken by the stockholders of the Corporation at any
annual or special meeting of stockholders of the Corporation must be effected at a duly called
annual or special meeting of stockholders and may not be taken or effected by a written consent of
stockholders in lieu thereof.
ARTICLE VII
DIRECTORS
Section 1. General. The business and affairs of the Corporation shall be managed by or
under the direction of the Board of Directors, except as otherwise provided for herein or required
by law.
Section 2. Election of Directors. Election of Directors need not be by written ballot
unless the By-laws of the Corporation shall so provide.
Section 3. Terms of Directors. The number of Directors of the Corporation shall be
fixed by resolution duly adopted from time to time by the Board of Directors.
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Notwithstanding the foregoing, whenever, pursuant to the provision of Article IV of this
Certificate of Incorporation, the holders of any one or more series of Preferred Stock shall have
the right, voting separately as a series or with holders of other such series, of Preferred Stock,
to elect Directors at an annual or special meeting of stockholders, the election, term of office,
filling of vacancies and other features of such directorships shall be governed by the terms of
this Certificate of Incorporation and any certificate of designations applicable thereto.
During any period when the holders of any series of Preferred Stock have the right to elect
additional Directors as provided for or fixed pursuant to the provisions of Article IV hereof, then
upon commencement and for the duration of the period during which such right continues; (i) the
then otherwise total authorized number of Directors of the Corporation shall automatically be
increased by such specified number of Directors, and the holders of such Preferred Stock shall be
entitled to elect the additional Directors so provided for or fixed pursuant to said provisions,
and (ii) each such additional Director shall serve until such Directors successor shall have been
duly elected or qualified, or until such Directors right to hold such office terminates pursuant
to said provisions, whichever occurs earlier, subject to such Directors earlier death,
disqualification, resignation or removal. Except as otherwise provided by the Board in the
resolution or resolutions establishing such series, whenever the holders of any series of Preferred
Stock having such right to elect additional Directors are divested of such right pursuant to the
provisions of such stock, the terms of office of all such additional Directors elected by the
holders of such stock, or elected to fill any vacancies resulting from the death, resignation,
disqualification or removal of such additional Directors, shall forthwith terminate and the total
and authorized number of Directors of the Corporation shall be reduced accordingly.
Section 4. Vacancies.
Subject to the rights, if any, of the holders of any series of Preferred Stock to elect
Directors and to fill vacancies in the Board of Directors relating thereto, any and all vacancies
and newly created directorships in the Board of Directors, however occurring, including, without
limitation, by reason of an increase in size of the Board of Directors, or the death, resignation,
disqualification or removal of a Director, shall be filled solely by the affirmative vote of a
majority of the remaining Directors then in office, even if less than a quorum of the Board of
Directors. Any Director appointed in accordance with the full preceding sentence shall hold office
until the next annual meeting of stockholders or until such Directors successor shall have been
duly elected or qualified or until his or her earlier death, resignation, or removal. In the event
of a vacancy in the Board of Directors, the remaining Directors, except as otherwise provided by
law, may exercise the powers of the full board of Directors until the vacancy is filled.
Section 5. Removal.
Subject to the rights, if any, of any series of Preferred Stock to elect Directors and to
remove any Director whom the holders of any such stock have the right to elect, any Director
(including persons elected by Directors to fill vacancies in the Board of Directors) may be
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removed from office only by the affirmative vote of at least two-thirds of the total votes which
would be eligible to be cast by stockholders in the election of such Director.
ARTICLE VIII
LIMITATION OF LIABILITY
A Director of the Corporation shall not be personally liable to the Corporation or its
stockholders for monetary damages for breach of fiduciary duty as a Director, except for liability
(i) for any breach of the Directors duty of loyalty to the Corporation or its stockholders, (ii)
for acts or omissions not in good faith or which involve intentional misconduct or a knowing
violation of law, (iii) under Section 174 of the DGCL or (iv) for any transaction from which the
Director derived an improper personal benefit. If the DGCL is amended after the effective date of
this Certificate of Incorporation to authorize corporate action further eliminating or limiting the
personal liability of Directors, then the liability of a Director of the Corporation shall be
eliminated or limited to the fullest extent permitted by the DGCL, as so amended.
Any repeal or modification of this Article VII by either of (i) the stockholders of the
Corporation or (ii) an amendment to the DGCL, shall not adversely affect any right or protection
existing at the time of such repeal or modification with respect to any acts or omissions occurring
before such repeal or modification of a person serving as a Director at the time of such repeal or
modification.
ARTICLE IX
AMENDMENT OF BY-LAWS
Section 1. Amendment by Directors. Except as otherwise provided by law, the By-laws
of the Corporation may be amended or repealed by the Board of Directors.
Section 2. Amendment by Stockholders. The By-laws of the Corporation may be amended
or repealed at any annual meeting of stockholders, or special meeting of stockholders called for
such purpose, by the affirmative vote of at least two-thirds of the total votes eligible to be cast
on such amendment or repeal by holders of voting stock, voting together as a single class,
provided, however, that if the Board of Directors recommends that stockholders approve such
amendment or repeal it shall only require the affirmative vote of a majority of the total votes
eligible to be cast on such amendment or repeal by holders of voting stock, voting as a single
class.
ARTICLE X
AMENDMENT OF CERTIFICATE OF INCORPORATION
The Corporation reserves the right to amend or repeal this Certificate of Incorporation in the
manner now or hereafter prescribed by statute and this Certificate of Incorporation, and all rights
conferred upon stockholders herein are granted subject to this reservation. No amendment or repeal
of this Certificate of Incorporation shall be made unless the same is first approved by the Board
of Directors pursuant to a resolution adopted by the Board of Directors in accordance with Section
242 of the DGCL, and, except as otherwise provided by law, thereafter approved by
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the stockholders. Whenever any vote of the holders of voting stock is required, and in addition to
any other vote of holders of voting stock that is required by this Certificate of Incorporation or
by law, the affirmative vote of a majority of the total votes eligible to be cast by holders of
voting stock with respect to such amendment or repeal, voting together as a single class at a duly
constituted meeting of stockholders called expressly for such purpose shall be required to amend or
repeal any provisions of this Certificate of Incorporation; provided, however, that the affirmative
vote of not less than 80% of the total votes eligible to be cast by holders of voting stock, voting
together as a single class, shall be required to amend or repeal any of the provisions of Article
VI, VII, VIII, IX or X of this Certificate of Incorporation.
Executed
this 21st day of July, 2006 by:
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/s/ Philip B. Schwartz
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Philip B. Schwartz, Incorporator |
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EXHIBIT 3.2 AMENDMENT TO CERT. OF INC.
Exhibit 3.2
CERTIFICATE OF AMENDMENT
TO THE
CERTIFICATE OF INCORPORATION
OF
CATALYST PHARMACEUTICAL PARTNERS, INC.,
a Delaware Corporation
Pursuant to Section 241 of the Delaware General Corporation Law (the DGCL), the Certificate
of Incorporation of CATALYST PHARMACEUTICAL PARTNERS, INC., a Delaware corporation, hereinafter
referred to as the corporation, is amended as follows:
1. The following is added to Article IV of the Certificate of Incorporation of the
Corporation:
Section 2. Series A Preferred Stock. The Corporation shall designate a series of
Preferred Stock, to be designated as Series A Preferred Stock, with the following rights,
privileges, and preferences:
(a) Designation and Amount. The shares of such series shall be
designated as Series A Preferred Stock (the Series A Preferred Stock) and the
number of shares constituting the Series A Preferred Stock shall be 500,000. Such
number of shares may be increased or decreased by resolution of the Board of
Directors; provided, that no decrease shall reduce the number of shares of Series A
Preferred Stock to a number less than the number of shares then outstanding plus the
number of shares reserved for issuance upon the exercise of outstanding options,
rights or warrants or upon the conversion of any outstanding securities issued by
the Corporation convertible into Series A Preferred Stock.
(b) Dividends and Distributions
(1) In the event that the Corporation declares, makes or pays any
dividends or other distributions upon the Common Stock (whether payable in
cash, securities, rights or other property), the Corporation shall also
declare and pay to the holders of the Series A Preferred Stock, at the same
time that it declares and pays such dividends or other distributions to the
holders of the Common Stock (and with the same record date), the dividends
or distributions which would have been declared and paid with respect to the
Common Stock issuable upon conversion of the Series A Preferred Stock had
all of the outstanding Series A Preferred Stock been converted immediately
prior to the record date for such dividend or distribution, or if no record
date is fixed, the date as of which the record holders of Common Stock
entitled to such dividends or distributions are determined.
(2) In the event the Corporation shall at any time after the issue date
declare and pay any dividend on the Common Stock payable in shares
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of Common Stock, or effect a subdivision or combination or consolidation of
the outstanding shares of Common Stock (by reclassification or otherwise
than by payment of a dividend in shares of Common Stock) into a greater or
lesser number of shares of Common Stock, then in each such case the amount
to which holders of shares of Series A Preferred Stock were entitled
immediately prior to such event shall be adjusted by multiplying such amount
by a fraction, the numerator of which is the number of shares of Common
Stock outstanding immediately after such event and the denominator of which
is the number of shares of Common Stock that were outstanding immediately
prior to such event.
(c) Conversion Rights.
(1) A
holder of shares of
Series A Preferred
Stock may convert
such shares into
Common Stock at any
time, at the option
of the holder
thereof. A holder
of shares of Series
A Preferred Stock
exercising his
conversion rights
shall receive that
number of shares of
Common Stock as is
determined by
dividing $10.00 by
the conversion
price then in
effect for such
Series A Preferred
Stock (the
Conversion
Price).
Initially, the
Conversion Price
for the Series A
Preferred Stock
shall be $1.00, and
each share of
Series A Preferred
Stock shall convert
into approximately
10 shares of Common
Stock.
(2)
To convert Series A Preferred Stock, a holder must (i) surrender the
certificate or
certificates
evidencing the shares of Series A
Preferred Stock to
be converted, duly
endorsed in a form
satisfactory to the
Corporation, at the
office of the
Corporation or
transfer agent for
the Series A
Preferred Stock;
(ii) notify the
Corporation at such
office that he
elects to convert
the Series A
Preferred Stock and
the number of shares he wishes to
convert; (iii)
state in writing
the name or names
in which he wishes
the certificate or
certificates for shares of Common
Stock to be issued;
and (iv) pay any
transfer or similar
tax if required.
In the event that a
holder fails to
notify the
Corporation of the
number of shares of
Series A Preferred
Stock which he
wishes to convert,
he shall be deemed
to have elected to
convert all shares
represented by the
certificate or
certificates
surrendered for
conversion. The
date on which the
holder satisfies
all those
requirements is the
Conversion Date.
As soon as
practical following
the Conversion
Date, the
Corporation shall
deliver a
certificate
representing the
number of full shares of Common
Stock issuable upon
the conversion, and
a new certificate
representing the
unconverted
portion, if any, of
the Series A
Preferred Stock
represented by the
certificate or
certificates
surrendered for
conversion. The
person in whose
name the Common
Stock certificate
is registered shall
be treated as the
shareholder of
record on and after
the Conversion
Date. The holder
of record of a
share of Series A
Preferred Stock at
the close
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Preferred Stock will be entitled to receive such dividends with respect to
such share of Series A Preferred Stock on the corresponding dividend payment
date, notwithstanding the conversion of such share after such record date
and prior to such dividend payment date.
(3) Each share of Series A Preferred Stock shall automatically and
without further action by the Corporation or any other party convert into
the number of shares of Common Stock as is determined by dividing $10.00 by
the Conversion Price then in effect for such Series A Preferred Stock upon
the occurrence of the following events: (i) the closing of a public offering
covering the offer and sale of the Corporations common stock for the
account of the Corporation at an aggregate offering price resulting in gross
proceeds to the Corporation of not less than $3,000,000; (ii) the acceptance
by the Nasdaq Stock Market, Inc., of the Corporations common stock for
listing and trading on the Nasdaq SmallCap Market, the Nasdaq National
Market or any national securities exchange and (iii) immediately prior to
the sale of all or substantially all of the Corporations assets or a merger
of the Corporation, so long as such sale or merger has been approved by a
majority of the holders of the Corporations outstanding shares (voting
together as a single voting group).
(4) In case the Corporation shall pay or make a dividend or other
distribution on any class of capital stock of the Corporation in Common
Stock, the Conversion Price in effect at the opening of business on the day
following the date fixed for the determination of shareholders entitled to
receive such dividend or other distribution shall be reduced by multiplying
such Conversion Price by a fraction the numerator of which shall be the
number of shares of Common Stock outstanding at the close of business on the
date fixed for such determination and the denominator of which shall be the
sum of such number of shares and the total number of shares constituting
such dividend or other distribution, such reduction to become effective
immediately after the opening of business on the day following the date
fixed for the determination of the holders entitled to such dividends and
distributions. For the purposes of this paragraph, the number of shares of
Common Stock at any time outstanding shall not include shares held in the
treasury of the Corporation. The Corporation will not pay any dividend or
make any distribution on shares of Common Stock held in the treasury of the
Corporation.
In case the outstanding shares of Common Stock shall be subdivided into
a greater number of shares of Common Stock, the Conversion Price in effect
at the opening of business on the day following the day upon which such
subdivision becomes effective shall be reduced, and conversely, in case the
outstanding share of Common Stock shall each be combined into a smaller
number of shares of Common Stock, the Conversion Price in effect at the
opening of business on the day following
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the day upon which such combination becomes effective shall be increased, in
either case to equal the product of the Conversion Price in effect on such
date and a fraction the numerator of which shall be the number of shares of
Common Stock outstanding immediately prior to such subdivision or
combination, as the case may be, and the denominator of which shall be the
number of shares of Common Stock outstanding immediately after such
subdivision or combination, as the case may be. Such reduction or increase,
as the case may be, shall become effective immediately after the opening of
business on the day following the day upon which such subdivision or
combination becomes effective.
(5) No adjustment in the Conversion Price need be made until all
cumulative adjustments amount to 1% or more of the Conversion Price as last
adjusted. Any adjustments that are not made shall be carried forward and
taken into account in any subsequent adjustment. Any adjustment to the
Conversion Price carried forward and not theretofore made shall be made
immediately prior to the conversion of any shares of Series A Preferred
Stock pursuant hereto. No adjustment in the Conversion Price shall reduce
the Conversion Price below the then par value of the Common Stock.
(6) Whenever the Conversion Price is adjusted, the Corporation shall
promptly mail to holders of the Series A Preferred Stock, first class,
postage prepaid, a notice of the adjustment. The Corporation shall file
with the transfer agent for the Series A Preferred Stock, if any, a
certificate from the Corporations chief executive officer briefly stating
the facts requiring the adjustment and the manner of computing it. In the
event of any dispute thereon, the opinion of the Corporations independent
public accountants, if accepted by the Board of Directors of the
Corporation, shall be conclusive and binding on the holders of the Series A
Preferred Stock absent manifest error.
(7) The Corporation will not, by amendment of its Certificate of
Incorporation or through any reorganization, recapitalization, transfer of
assets, consolidation, merger, dissolution, issue or sale of securities or
any other voluntary action, avoid or seek to avoid the observance or
performance of any of the terms to be observed or performed hereunder by
this Corporation, but will at all times in good faith assist in the carrying
out of all the provisions of this Section 2 and in the taking of all such
action as may be necessary or appropriate in order to protect the conversion
rights of the holders of the Series A Preferred Stock against impairment.
(8) No fractional shares shall be issued upon the conversion of any
share or shares of the Series A Preferred Stock, and the number of shares of
Common Stock to be issued shall be rounded to the nearest
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whole share. Whether or not fractional shares are issuable upon such
conversion shall be determined on the basis of the total number of shares of
Series A Preferred Stock the holder is at the time converting into Common
Stock and the number of shares of Common Stock issuable upon such aggregate
conversion.
(9) Immediately following any such conversion, the rights of the
holders of converted Series A Preferred Stock shall cease and the persons
entitled to receive the Common Stock upon the conversion of the Series A
Preferred Stock shall be treated for all purposes as having become the
owners of such Common Stock.
(d) Status of Converted Series A Preferred Stock. Any shares of Series
A Preferred Stock which shall at any time have been converted pursuant to Section 2
shall, after such conversion, have the status of authorized but unissued shares of
preferred stock, without designation as to series until such shares are once more
designated as part of a particular series by the Board of Directors. After
conversion of the Series A Preferred Stock, such shares shall
not be reissued as shares of Series A Preferred Stock and the Company shall take such actions as are
necessary to retire such stock and eliminate the authorization for the Series A
Preferred Stock from the Certificate of Incorporation, which shall not require any
further action of the stockholders.
(e) Voting Rights. The holders of shares of Series A Preferred Stock
shall have the following voting rights:
(1) Except as otherwise provided in the Certificate of Incorporation or
required by law, each share of Series A Preferred Stock shall entitle the
holder thereof to one vote for each share of Common Stock issuable upon
conversion of the Series A Preferred Stock as of the record date for such
vote (or action) or, if no record date is specified, as of the date of such
vote (or action) on all matters upon which the holders of the Common Stock
of the Corporation are entitled to vote.
(2) Except as otherwise provided herein and except as otherwise required by
law, the holders of shares of Series A Preferred Stock and the
holders of shares of Common Stock and any other capital stock of the Corporation having
general voting rights shall vote together as one class on all matters
submitted to a vote of shareholders of the Corporation. The Series A
Preferred Stock will be required to approve as a class, certain corporate
actions, which require shareholder approval, including (i) any increase in
authorized shares of any series of capital stock which are on par with or
senior to the Series A Preferred Stock with respect to voting, liquidation
or dividends, and (ii) any amendment to the Certificate of Incorporation or
Bylaws of the Corporation which alters or changes the rights, preferences or
privileges of the Series A Preferred Stock.
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(f) Liquidation Preference. Upon any voluntary or involuntary
liquidation, dissolution or winding-up of the Corporation, each holder of shares of
Series A Preferred Stock will be entitled to payment out of the assets of the
Corporation available for distribution of an amount equal to $10.00 per share of the
Series A Preferred Stock held by such holder, plus an amount equal to any declared
but unpaid dividends (the Series A Liquidation Preference), if any, to the date
fixed for liquidation, dissolution or winding-up, before any distribution is made on
any junior securities, including, without limitation, the Common Stock of the
Corporation. After payment in full of the Series A Liquidation Preference, if any,
to which holders of the Series A Preferred Stock are entitled, such holders will not
be entitled to any further participation in any distribution of assets of the
Corporation. If, upon any voluntary or involuntary liquidation, dissolution or
winding-up of the Corporation, the amounts payable with respect to the Series A
Preferred Stock and all other securities ranking pari passu with the Series A
Preferred Stock and senior to the Common Stock (the Parity Securities) are not
paid in full, the holders of the Series A Preferred Stock and the Parity Securities
will share equally and ratably in any distribution of assets of the Corporation in
proportion to the full liquidation preference, if any, to which each is entitled.
However, neither the voluntary sale, conveyance, exchange or transfer
(for cash, shares of stock, securities or other consideration) of all or substantially all of
the property or assets of the Corporation nor the consolidation or merger of the
Corporation with or into one or more Persons will be deemed to be a voluntary or
involuntary liquidation, dissolution or winding-up of the Corporation, unless such
sale, conveyance, exchange or transfer shall be in connection with a liquidation,
dissolution or winding-up of the business of the Corporation.
(g) No Redemption. The shares of Series A Preferred Stock will not be
redeemable.
(h)
Rank. The Series A Preferred Stock shall rank pari passu with the shares of the Series B Preferred Stock of the Corporation (as described below) and
senior to any other class of preferred stock that hereafter may be issued by the
Corporation as to the payment of dividends and the distribution of assets, unless
the terms of any such series or class shall provide otherwise.
(i) Amendment. If any proposed amendment to the Certificate of
Incorporation (including this Certificate of Amendment to the Certificate of
Incorporation) would alter, change or repeal any of the preferences, powers or
special rights given to the Series A Preferred Stock so as to affect the Series A
Preferred Stock adversely, then the holders of the Series A Preferred Stock shall be
entitled to vote separately as a class upon such amendment, and the affirmative vote
of a majority or more of the outstanding shares of the Series A Preferred Stock,
voting separately as a class, shall be necessary for the adoption thereof, in
addition to such other vote as may be required by the Delaware General Corporation
Act.
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Section 3. Series B Preferred Stock. The Corporation shall designate a series of
Preferred Stock, to be designated as Series B Preferred Stock, with the following rights,
privileges, and preferences:
(a) Designation and Amount. The shares of such series shall be
designated as Series B Preferred Stock (the Series B Preferred Stock) and the
number of shares constituting Series B Preferred Stock shall be 11,500. Such number
of shares may be increased or decreased by resolution of the Board of Directors;
provided, however, that no decrease shall reduce the number of shares of Series B
Preferred Stock to a number less than the number of shares then reserved for
issuance upon the exercise of outstanding options, rights, or warrants or upon the
conversion of any outstanding securities of the Corporation convertible into Series
B Preferred Stock.
(b) Dividends and Distributions
(1) In the event that the Corporation declares, makes, or pays any
dividends or other distributions upon the Common Stock (whether payable in
cash, securities, rights or other property), the Corporation shall also
declare and pay to the holders of the Series B Preferred Stock, at the same
time that it declares and pays such dividends or other distributions to the
holders of the Common Stock (and with the same record date), the dividends
or distributions which would have been declared and paid with respect to the
outstanding Series B Preferred Stock had all of the outstanding Series B
Preferred Stock been converted immediately prior to the record date for such
dividend or distribution, or if no record date is fixed, the date as of
which the record holders of Common Stock entitled to such dividends or
distributions are determined.
(2) In the event that the Corporation shall at any time after the issue
date declare and pay any dividend on the Common Stock payable in shares of
Common Stock, or effect a subdivision or combination or consolidation of the
outstanding shares of Common Stock (by reclassification or otherwise than by
payment of a dividend in shares of Common Stock) into a greater or lesser
number of shares of Common Stock, then in each such case the amount to which
holders of shares of Series B Preferred Stock were entitled immediately
prior to such event shall be adjusted by multiplying such amount by a
fraction, the numerator of which is the number of shares of Common Stock
outstanding after such event and the denominator of which is the
number of shares of Common Stock that were outstanding immediately prior to such
event.
(c) Conversion Rights
(1)
A holder of shares of Series B Preferred Stock may convert such shares into Common Stock at any time, at the option of the holder
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thereof. A holder of shares of Series B Preferred Stock exercising his
conversion rights shall receive 100 shares of Common Stock for each share of
Series B Preferred Stock.
(2) To convert Series B Preferred Stock, a holder must (i) surrender
the certificate or certificates evidencing the shares of Series B Preferred
Stock to be converted, duly endorsed in a form satisfactory to the
Corporation, at the office of the Corporation or transfer agent for the
Series B Preferred Stock; (ii) notify the Corporation at such office that he
elects to convert the Series B Preferred Stock and the number of shares he
wishes to convert; (iii) state in writing the name or names in which he
wishes the certificate or certificates for shares of Common Stock to be
issued; and (iv) pay any transfer or similar tax if required. In the event
that a holder fails to notify the Corporation of the number of shares of
Series B Preferred Stock which he wishes to convert, he shall be deemed to
have elected to convert all shares represented by the certificate or
certificates surrendered for conversion. As soon as practical following the
Conversion Date, the Corporation shall deliver a certificate representing
the number of full shares of Common Stock issuable upon the conversion, and
a new certificate representing the unconverted portion, if any, of the
Series B Preferred Stock represented by the certificate or certificates
surrendered for conversion. The person in whose name the Common Stock
certificate is registered shall be treated as the shareholder of record on
and after the Conversion Date. The holder of record of a share of Series B
Preferred Stock at the close of business on a record date with respect to
the payment of dividends on the Series B Preferred Stock will be entitled to
receive such dividends with respect to such share of Series B Preferred
Stock on the corresponding dividend payment date, notwithstanding the
conversion of such share after such record date and prior to such dividend
payment date.
(3) Each share of Series B Preferred Stock shall automatically and
without further action by the Corporation or any other party convert into
100 shares of Common Stock upon the occurrence of the following events: (i)
the closing of a public offering covering the offer and sale of the
Corporations common stock for the account of the Corporation at an
aggregate offering price resulting in gross proceeds to the Corporation of
not less than $20,000,000; (ii) the acceptance by the Nasdaq Stock Market,
Inc., or a national securities exchange, of the Corporations common stock
for listing and trading on the Nasdaq SmallCap Market, the Nasdaq National
Market or any national securities exchange and (iii) immediately prior to
the sale of all or substantially all of the Corporations assets or a merger
of the Corporation, so long as such sale or merger has been approved by a
majority of the holders of the Corporations outstanding shares (voting
together as a single voting group).
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(4) In case the Corporation shall pay or make a dividend or other
distribution on any class of capital stock of the Corporation in Common
Stock, the Conversion Price in effect at the opening of business on the day
following the date fixed for the determination of shareholders entitled to
receive such dividend or other distribution shall be reduced by multiplying
such Conversion Price by a fraction the numerator of which shall be the
number of shares of Common Stock outstanding at the close of business on the
date fixed for such determination and the denominator of which shall be the
sum of such number of shares and the total number of shares constituting
such dividend or other distribution, such reduction to become effective
immediately after the opening of business on the day following the date
fixed for the determination of the holders entitled to such dividends and
distributions. For the purposes of this paragraph, the number of shares of
Common Stock at any time outstanding shall not include shares held in the
treasury of the Corporation. The Corporation will not pay any dividend or
make any distribution on shares of Common Stock held in the treasury of the
Corporation.
In case the outstanding shares of Common Stock shall be subdivided into
a greater number of shares of Common Stock, the Conversion Price in effect
at the opening of business on the day following the day upon which such
subdivision becomes effective shall be reduced, and conversely, in case the
outstanding share of Common Stock shall each be combined into a smaller
number of shares of Common Stock, the Conversion Price in effect at the
opening of business on the day following the day upon which such combination
becomes effective shall be increased, in either case to equal the product of
the Conversion Price in effect on such date and a fraction the numerator of
which shall be the number of shares of Common Stock outstanding immediately
prior to such subdivision or combination, as the case may be, and the
denominator of which shall be the number of shares of Common Stock
outstanding immediately after such subdivision or combination, as the case
may be. Such reduction or increase, as the case may be, shall become
effective immediately after the opening of business on the day following the
day upon which such subdivision or combination becomes effective.
(5) The Corporation will not, by amendment of its Certificate of
Incorporation or through any reorganization, recapitalization, transfer of
assets, consolidation, merger, dissolution, issue or sale of securities or
any other voluntary action, avoid or seek to avoid the observance or
performance of any of the terms to be observed or performed hereunder by
this Corporation, but will at all times in good faith assist in the carrying
out of all the provisions of this Section 3 and in the taking of all such
action as may be necessary or appropriate in order to protect the conversion
rights of the holders of the Series B Preferred Stock against impairment.
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(6) Immediately following any such conversion, the rights of the
holders of converted Series B Preferred Stock shall cease and the persons
entitled to receive the Common Stock upon the conversion of the Series B
Preferred Stock shall be treated for all purposes as having become the
owners of such Common Stock.
(d) Status of Converted Series B Preferred Stock. Any shares of Series
B Preferred Stock which shall at any time have been converted pursuant to this
Section 3 shall, after such conversion, have the status of
authorized but unissued shares of preferred stock, without designation as to series until such shares are
once more designated as part of a particular series by the Board of Directors.
After conversion of the Series B Preferred Stock, such shares shall not be reissued
as shares of Series B Preferred Stock and the Company shall take such actions as are
necessary to retire such stock and eliminate the authorization for the Series B
Preferred Stock from the Certificate of Incorporation, which shall not require any
further action of the stockholders.
(e) Voting Rights. The holders of shares of Series B Preferred Stock
shall have the following voting rights:
(1) Except as otherwise provided in the Certificate of Incorporation or
required by law, each share of Series B Preferred Stock shall entitle the
holder thereof to one vote for each share of Common Stock issuable upon
conversion of the Series B Preferred Stock as of the record date for such
vote (or action) or, if no record date is specified, as of the date of such
vote (or action) on all matters upon which the holders of the Common Stock
of the Corporation are entitled to vote.
(2) Except as otherwise provided herein and except as otherwise
required by law, the holders of shares of Series B Preferred Stock and the
holders of shares of Common Stock and any other capital stock of the
Corporation having general voting rights shall vote together as one class on
all matters submitted to a vote of shareholders of the Corporation. The
Series B Preferred Stock will be required to approve as a class, certain
corporate actions, which require shareholder approval, including (i) any
increase in authorized shares of any series of capital stock which are on
par with or senior to the Series B Preferred Stock with respect to voting,
liquidation or dividends, and (ii) any amendment to the Certificate of
Incorporation or Bylaws of the Corporation which alters or changes the
rights, preferences or privileges of the Series B Preferred Stock.
(f) Liquidation Preference. Upon any voluntary or involuntary
liquidation, dissolution or winding-up of the Corporation, each holder of shares of
Series B Preferred Stock will be entitled to payment out of the assets of the
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Corporation available for distribution of an amount equal to $435.00 per share
of the Series B Preferred Stock held by such holder, plus an amount equal to any
declared but unpaid dividends (the Series B Liquidation Preference), if any, to
the date fixed for liquidation, dissolution or winding-up, before any distribution
is made on any junior securities, including, without limitation, the Common Stock of
the Corporation. After payment in full of the Series B Liquidation Preference, if
any, to which holders of the Series B Preferred Stock are entitled, such holders
will not be entitled to any further participation in any distribution of assets of
the Corporation. If, upon any voluntary or involuntary liquidation, dissolution or
winding-up of the Corporation, the amounts payable with respect to the Series B
Preferred Stock and all other securities ranking pari passu with the Series B
Preferred Stock and senior to the Common Stock are not paid in full, the holders of
the Series B Preferred Stock and the Parity Securities will share equally and
ratably in any distribution of assets of the Corporation in proportion to the full
liquidation preference, if any, to which each is entitled. However, neither the
voluntary sale, conveyance, exchange or transfer (for cash, shares of stock,
securities or other consideration) of all or substantially all of the property or
assets of the Corporation nor the consolidation or merger of the Corporation with or
into one or more Persons will be deemed to be a voluntary or involuntary
liquidation, dissolution or winding-up of the Corporation, unless such sale,
conveyance, exchange or transfer shall be in connection with a liquidation,
dissolution or winding-up of the business of the Corporation.
(g) No Redemption. The shares of Series B Preferred Stock will not be
redeemable.
(h)
Rank. The Series B Preferred Stock shall rank pari pasu with the shares of the Series A Preferred Stock, par value $.01 per share, and senior to any
other class of preferred stock that hereafter may be issued by the Corporation as to
the payment of dividends and the distribution of assets, unless the terms of any
such series or class shall provide otherwise.
(i) Amendment. If any proposed amendment to the Certificate of
Incorporation (including this Certificate of Amendment to the Certificate of
Incorporation) would alter, change or repeal any of the preferences, powers or
special rights given to the Series B Preferred Stock so as to affect the Series B
Preferred Stock adversely, then the holders of the Series B Preferred Stock shall be
entitled to vote separately as a class upon such amendment, and the affirmative vote
of a majority or more of the outstanding shares of the Series B Preferred Stock,
voting separately as a class, shall be necessary for the adoption thereof, in
addition to such other vote as may be required by the Delaware General Corporation
Act.
* * *
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2. Except as provided for above, the Certificate of Incorporation of the Corporation shall
remain unchanged and unamended.
3. The Corporation has not received any payment for any of its capital stock.
On
July 21, 2006, the incorporator of the Corporation approved the changes that are being made
to the Certificate of Incorporation prior to the organization of the Corporation, the appointment
of a Board of Directors and the issuance of or payment for any capital stock.
IN WITNESS WHEREOF, the undersigned, as incorporator of the Corporation, has executed this
Certificate of Amendment on this 21st day of July, 2006.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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By: |
/s/ Philip B. Schwartz
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Philip B. Schwartz, Incorporator |
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EXHIBIT 3.3 BY-LAWS
Exhibit 3.3
BY-LAWS
OF
CATALYST PHARMACEUTICAL PARTNERS, INC.
ARTICLE I
Meetings of Stockholders
Section 1.1. Annual Meetings. If required by applicable law, an annual meeting of
stockholders shall be held for the election of directors at such date, time and place, if any,
either within or without the State of Delaware, as may be designated by resolution of the Board of
Directors from time to time. Any other proper business may be transacted at the annual meeting.
Section 1.2. Special Meetings. Special meetings of stockholders for any purpose or
purposes may be called at any time by the Board of Directors, but such special meetings may not be
called by any other person or persons. Business transacted at any special meeting of stockholders
shall be limited to the purposes stated in the notice.
Section 1.3. Notice of Meetings. Whenever stockholders are required or permitted to
take any action at a meeting, a notice of the meeting shall be given that shall state the place, if
any, date and hour of the meeting and, in the case of a special meeting, the purpose or purposes
for which the meeting is called. Unless otherwise provided by law, the certificate of
incorporation or these by-laws, the notice of any meeting shall be given not less than ten (10) nor
more than sixty (60) days before the date of the meeting to each stockholder entitled to vote at
such meeting. If mailed, such notice shall be deemed to be given when deposited in the United
States mail, postage prepaid, directed to the stockholder at such stockholders address as it
appears on the records of the corporation.
Section 1.4. Adjournments. Any meeting of stockholders, annual or special, may
adjourn from time to time to reconvene at the same or some other place, and notice need not be
given of any such adjourned meeting if the time and place thereof are announced at the meeting at
which the adjournment is taken. At the adjourned meeting the corporation may transact any business
which might have been transacted at the original meeting. If the adjournment is for more than
thirty (30) days, or if after the adjournment a new record date is fixed for the adjourned meeting,
notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at
the meeting.
Section 1.5. Quorum. Except as otherwise provided by law, the certificate of
incorporation or these by-laws, at each meeting of stockholders the presence in person or by proxy
of the holders of a majority in voting power of the outstanding shares of stock entitled to vote at
the meeting shall be necessary and sufficient to constitute a quorum. In the absence of a
1
quorum, the stockholders so present may, by a majority in voting power thereof, adjourn the
meeting from time to time in the manner provided in Section 1.4 of these by-laws until a quorum
shall attend. Shares of its own stock belonging to the corporation or to another corporation, if a
majority of the shares entitled to vote in the election of directors of such other corporation is
held, directly or indirectly, by the corporation, shall neither be entitled to vote nor be counted
for quorum purposes; provided, however, that the foregoing shall not limit the right of the
corporation or any subsidiary of the corporation to vote stock, including but not limited to its
own stock, held by it in a fiduciary capacity.
Section 1.6. Organization. Meetings of stockholders shall be presided over by the
Chairperson of the Board, if any, or in his or her absence by the Vice Chairperson of the Board, if
any, or in his or her absence by the President, or in his or her absence by a Vice President, or in
the absence of the foregoing persons by a chairperson designated by the Board of Directors, or in
the absence of such designation by a chairperson chosen at the meeting. The Secretary shall act as
secretary of the meeting, but in his or her absence the chairperson of the meeting may appoint any
person to act as secretary of the meeting.
Section 1.7. Voting; Proxies. Except as otherwise provided by or pursuant to the
provisions of the certificate of incorporation, each stockholder entitled to vote at any meeting of
stockholders shall be entitled to one vote for each share of stock held by such stockholder which
has voting power upon the matter in question. Each stockholder entitled to vote at a meeting of
stockholders or to express consent to corporate action in writing without a meeting may authorize
another person or persons to act for such stockholder by proxy, but no such proxy shall be voted or
acted upon after three years from its date, unless the proxy provides for a longer period. A proxy
shall be irrevocable if it states that it is irrevocable and if, and only as long as, it is coupled
with an interest sufficient in law to support an irrevocable power. A stockholder may revoke any
proxy which is not irrevocable by attending the meeting and voting in person or by delivering to
the Secretary of the corporation a revocation of the proxy or a new proxy bearing a later date.
Voting at meetings of stockholders need not be by written ballot. At all meetings of stockholders
for the election of directors at which a quorum is present a plurality of the votes cast shall be
sufficient to elect. All other elections and questions presented to the stockholders at a meeting
at which a quorum is present shall, unless otherwise provided by the certificate of incorporation,
these by-laws, the rules or regulations of any stock exchange applicable to the corporation, or
applicable law or pursuant to any regulation applicable to the corporation or its securities, be
decided by the affirmative vote of the holders of a majority in voting power of the shares of stock
of the corporation which are present in person or by proxy and entitled to vote thereon.
Section 1.8. Fixing Date for Determination of Stockholders of Record. In order that
the corporation may determine the stockholders entitled to notice of or to vote at any meeting of
stockholders or any adjournment thereof, or to express consent to corporate action in writing
without a meeting, or entitled to receive payment of any dividend or other distribution or
allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or
exchange of stock or for the purpose of any other lawful action, the Board of Directors may fix a
record date, which record date shall not precede the date upon which the resolution fixing the
record date is adopted by the Board of Directors, and which record date: (1) in the case of
determination of stockholders entitled to vote at any meeting of stockholders or adjournment
thereof, shall, unless otherwise required by law, not be more than sixty (60) nor less than ten
(10)
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days before the date of such meeting; (2) in the case of determination of stockholders
entitled to express consent to corporate action in writing without a meeting, shall not be more
than ten (10) days from the date upon which the resolution fixing the record date is adopted by the
Board of Directors; and (3) in the case of any other action, shall not be more than sixty (60) days
prior to such other action. If no record date is fixed: (1) the record date for determining
stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of
business on the day next preceding the day on which notice is given, or, if notice is waived, at
the close of business on the day next preceding the day on which the meeting is held; (2) the
record date for determining stockholders entitled to express consent to corporate action in writing
without a meeting, when no prior action of the Board of Directors is required by law, shall be the
first date on which a signed written consent setting forth the action taken or proposed to be taken
is delivered to the corporation in accordance with applicable law, or, if prior action by the Board
of Directors is required by law, shall be at the close of business on the day on which the Board of
Directors adopts the resolution taking such prior action; and (3) the record date for determining
stockholders for any other purpose shall be at the close of business on the day on which the Board
of Directors adopts the resolution relating thereto. A determination of stockholders of record
entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the
meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned
meeting.
Section 1.9. List of Stockholders Entitled to Vote. The officer who has charge of
the stock ledger shall prepare and make, at least ten (10) days before every meeting of
stockholders, a complete list of the stockholders entitled to vote at the meeting, arranged in
alphabetical order, and showing the address of each stockholder and the number of shares registered
in the name of each stockholder. Such list shall be open to the examination of any stockholder,
for any purpose germane to the meeting at least ten (10) days prior to the meeting (i) on a
reasonably accessible electronic network, provided that the information required to gain access to
such list is provided with the notice of meeting or (ii) during ordinary business hours at the
principal place of business of the corporation. The list of stockholders must also be open to
examination at the meeting as required by applicable law. Except as otherwise provided by law, the
stock ledger shall be the only evidence as to who are the stockholders entitled to examine the list
of stockholders required by this Section 1.9 or to vote in person or by proxy at any meeting of
stockholders.
Section 1.10. Action By Written Consent of Stockholders. Unless otherwise restricted
by the certificate of incorporation, any action required or permitted to be taken at any annual or
special meeting of the stockholders may be taken without a meeting, without prior notice and
without a vote, if a consent or consents in writing, setting forth the action so taken, shall be
signed by the holders of outstanding stock having not less than the minimum number of votes that
would be necessary to authorize or take such action at a meeting at which all shares entitled to
vote thereon were present and voted and shall be delivered to the corporation by delivery to its
registered office in the State of Delaware, its principal place of business, or an officer or agent
of the corporation having custody of the book in which minutes of proceedings of stockholders are
recorded. Delivery made to the corporations registered office shall be by hand or by certified or
registered mail, return receipt requested. Prompt notice of the taking of the corporate action
without a meeting by less than unanimous written consent shall, to the extent required by law, be
given to those stockholders who have not consented in writing and who, if the action had been taken
at a meeting, would have been entitled to notice of the meeting if the
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record date for such meeting had been the date that written consents signed by a sufficient
number of holders to take the action were delivered to the corporation.
Section 1.11. Inspectors of Election. The corporation may, and shall if required by
law, in advance of any meeting of stockholders, appoint one or more inspectors of election, who may
be employees of the corporation, to act at the meeting or any adjournment thereof and to make a
written report thereof. The corporation may designate one or more persons as alternate inspectors
to replace any inspector who fails to act. In the event that no inspector so appointed or
designated is able to act at a meeting of stockholders, the person presiding at the meeting shall
appoint one or more inspectors to act at the meeting. Each inspector, before entering upon the
discharge of his or her duties, shall take and sign an oath to execute faithfully the duties of
inspector with strict impartiality and according to the best of his or her ability. The inspector
or inspectors so appointed or designated shall (i) ascertain the number of shares of capital stock
of the corporation outstanding and the voting power of each such share, (ii) determine the shares
of capital stock of the corporation represented at the meeting and the validity of proxies and
ballots, (iii) count all votes and ballots, (iv) determine and retain for a reasonable period a
record of the disposition of any challenges made to any determination by the inspectors, and (v)
certify their determination of the number of shares of capital stock of the corporation represented
at the meeting and such inspectors count of all votes and ballots. Such certification and report
shall specify such other information as may be required by law. In determining the validity and
counting of proxies and ballots cast at any meeting of stockholders of the corporation, the
inspectors may consider such information as is permitted by applicable law. No person who is a
candidate for an office at an election may serve as an inspector at such election.
Section 1.12. Conduct of Meetings. The date and time of the opening and the closing
of the polls for each matter upon which the stockholders will vote at a meeting shall be announced
at the meeting by the person presiding over the meeting. The Board of Directors may adopt by
resolution such rules and regulations for the conduct of the meeting of stockholders as it shall
deem appropriate. Except to the extent inconsistent with such rules and regulations as adopted by
the Board of Directors, the person presiding over any meeting of stockholders shall have the right
and authority to convene and to adjourn the meeting, to prescribe such rules, regulations and
procedures and to do all such acts as, in the judgment of such presiding person, are appropriate
for the proper conduct of the meeting. Such rules, regulations or procedures, whether adopted by
the Board of Directors or prescribed by the presiding person of the meeting, may include, without
limitation, the following: (i) the establishment of an agenda or order of business for the meeting;
(ii) rules and procedures for maintaining order at the meeting and the safety of those present;
(iii) limitations on attendance at or participation in the meeting to stockholders of record of the
corporation, their duly authorized and constituted proxies or such other persons as the presiding
person of the meeting shall determine; (iv) restrictions on entry to the meeting after the time
fixed for the commencement thereof; and (v) limitations on the time allotted to questions or
comments by participants. The presiding person at any meeting of stockholders, in addition to
making any other determinations that may be appropriate to the conduct of the meeting, shall, if
the facts warrant, determine and declare to the meeting that a matter or business was not properly
brought before the meeting and if such presiding person should so determine, such presiding person
shall so declare to the meeting and any such matter or business not properly brought before the
meeting shall not be transacted or considered. Unless and to the extent determined by the Board of
Directors or the person presiding over the
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meeting, meetings of stockholders shall not be required to be held in accordance with the rules of
parliamentary procedure.
Section 1.13. Notice of Stockholder Business and Nominations.
(A) Annual Meetings of Stockholders.
(1) Nominations of persons for election to the Board of Directors and the proposal of business
to be considered by the stockholders may be made at an annual meeting of stockholders only (a)
pursuant to the corporations notice of meeting (or any supplement thereto), (b) by or at the
direction of the Board of Directors or (c) by any stockholder of the corporation who was a
stockholder of record of the corporation at the time the notice provided for in this Section 1.13
is delivered to the Secretary of the corporation, who is entitled to vote at the meeting and who
complies with the notice procedures set forth in this Section 1.13.
(2) For nominations or other business to be properly brought before an annual meeting by a
stockholder pursuant to clause (c) of paragraph (A)(1) of this Section 1.13, the stockholder must
have given timely notice thereof in writing to the Secretary of the corporation and any such
proposed business other than the nominations of persons for election to the Board of Directors must
constitute a proper matter for stockholder action. To be timely, a stockholders notice shall be
delivered to the Secretary at the principal executive offices of the corporation not later than the
close of business on the ninetieth day nor earlier than the close of business on the one hundred
twentieth day prior to the first anniversary of the preceding years annual meeting (provided,
however, that in the event that the date of the annual meeting is more than thirty days before or
more than seventy days after such anniversary date, notice by the stockholder must be so delivered
not earlier than the close of business on the one hundred twentieth day prior to such annual
meeting and not later than the close of business on the later of the ninetieth day prior to such
annual meeting or the tenth day following the day on which public announcement of the date of such
meeting is first made by the corporation). In no event shall the public announcement of an
adjournment or postponement of an annual meeting commence a new time period (or extend any time
period) for the giving of a stockholders notice as described above. Such stockholders notice
shall set forth: (a) as to each person whom the stockholder proposes to nominate for election as a
director (i) all information relating to such person that is required to be disclosed in
solicitations of proxies for election of directors in an election contest, or is otherwise
required, in each case pursuant to and in accordance with Regulation 14A under the Securities
Exchange Act of 1934, as amended (the Exchange Act) and (ii) such persons written consent to
being named in the proxy statement as a nominee and to serving as a director if elected; (b) as to
any other business that the stockholder proposes to bring before the meeting, a brief description
of the business desired to be brought before the meeting, the text of the proposal or business
(including the text of any resolutions proposed for consideration and in the event that such
business includes a proposal to amend the Bylaws of the corporation, the language of the proposed
amendment), the reasons for conducting such business at the meeting and any material interest in
such business of such stockholder and the beneficial owner, if any, on whose behalf the proposal is
made; and (c) as to the stockholder giving the notice and the beneficial owner, if any, on whose
behalf the nomination or proposal is made (i) the name and address of such stockholder, as they
appear on the corporations books, and of such beneficial owner, (ii) the class and number of
shares of capital stock of the corporation which are owned beneficially and of record by such
stockholder and such beneficial owner, (iii) a representation
5
that the stockholder is a holder of record of stock of the corporation entitled to vote at
such meeting and intends to appear in person or by proxy at the meeting to propose such business or
nomination, and (iv) a representation whether the stockholder or the beneficial owner, if any,
intends or is part of a group which intends (a) to deliver a proxy statement and/or form of proxy
to holders of at least the percentage of the corporations outstanding capital stock required to
approve or adopt the proposal or elect the nominee and/or (b) otherwise to solicit proxies from
stockholders in support of such proposal or nomination. The foregoing notice requirements of this
Section 1.13 shall be deemed satisfied by a stockholder if the stockholder has notified the
corporation of his or her intention to present a proposal or nomination at an annual meeting in
compliance with applicable rules and regulations promulgated under the Exchange Act and such
stockholders proposal or nomination has been included in a proxy statement that has been prepared
by the corporation to solicit proxies for such annual meeting. The corporation may require any
proposed nominee to furnish such other information as it may reasonably require to determine the
eligibility of such proposed nominee to serve as a director of the corporation.
(3) Notwithstanding anything in the second sentence of paragraph (A)(2) of this Section 1.13
to the contrary, in the event that the number of directors to be elected to the Board of Directors
at an annual meeting is increased and there is no public announcement by the corporation naming the
nominees for the additional directorships at least one hundred days prior to the first anniversary
of the preceding years annual meeting, a stockholders notice required by this Section 1.13 shall
also be considered timely, but only with respect to nominees for the additional directorships, if
it shall be delivered to the Secretary at the principal executive offices of the corporation not
later than the close of business on the tenth day following the day on which such public
announcement is first made by the corporation.
(B) Special Meetings of Stockholders. Only such business shall be conducted at a special
meeting of stockholders as shall have been brought before the meeting pursuant to the corporations
notice of meeting. Nominations of persons for election to the Board of Directors may be made at a
special meeting of stockholders at which directors are to be elected pursuant to the corporations
notice of meeting (1) by or at the direction of the Board of Directors or (2) provided that the
Board of Directors has determined that directors shall be elected at such meeting, by any
stockholder of the corporation who is a stockholder of record at the time the notice provided for
in this Section 1.13 is delivered to the Secretary of the corporation, who is entitled to vote at
the meeting and upon such election and who complies with the notice procedures set forth in this
Section 1.13. In the event the corporation calls a special meeting of stockholders for the purpose
of electing one or more directors to the Board of Directors, any such stockholder entitled to vote
in such election of directors may nominate a person or persons (as the case may be) for election to
such position(s) as specified in the corporations notice of meeting, if the stockholders notice
required by paragraph (A)(2) of this Section 1.13 shall be delivered to the Secretary at the
principal executive offices of the corporation not earlier than the close of business on the one
hundred twentieth day prior to such special meeting and not later than the close of business on the
later of the ninetieth day prior to such special meeting or the tenth day following the day on
which public announcement is first made of the date of the special meeting and of the nominees
proposed by the Board of Directors to be elected at such meeting. In no event shall the public
announcement of an adjournment or postponement of a special meeting commence a new time period (or
extend any time period) for the giving of a stockholders notice as described above.
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(C) General.
(1) Only such persons who are nominated in accordance with the procedures set forth in this
Section 1.13 shall be eligible to be elected at an annual or special meeting of stockholders of the
corporation to serve as directors and only such business shall be conducted at a meeting of
stockholders as shall have been brought before the meeting in accordance with the procedures set
forth in this Section 1.13. Except as otherwise provided by law, the chairman of the meeting shall
have the power and duty (a) to determine whether a nomination or any business proposed to be
brought before the meeting was made or proposed, as the case may be, in accordance with the
procedures set forth in this Section 1.13 (including whether the stockholder or beneficial owner,
if any, on whose behalf the nomination or proposal is made solicited (or is part of a group which
solicited) or did not so solicit, as the case may be, proxies in support of such stockholders
nominee or proposal in compliance with such stockholders representation as required by clause
(A)(2)(c)(iv) of this Section 1.13) and (b) if any proposed nomination or business was not made or
proposed in compliance with this Section 1.13, to declare that such nomination shall be disregarded
or that such proposed business shall not be transacted. Notwithstanding the foregoing provisions
of this Section 1.13, unless otherwise required by law, if the stockholder (or a qualified
representative of the stockholder) does not appear at the annual or special meeting of stockholders
of the corporation to present a nomination or proposed business, such nomination shall be
disregarded and such proposed business shall not be transacted, notwithstanding that proxies in
respect of such vote may have been received by the corporation. For purposes of this Section 1.13,
to be considered a qualified representative of the stockholder, a person must be authorized by a
writing executed by such stockholder or an electronic transmission delivered by such stockholder to
act for such stockholder as proxy at the meeting of stockholders and such person must produce such
writing or electronic transmission, or a reliable reproduction of the writing or electronic
transmission, at the meeting of stockholders.
(2) For purposes of this Section 1.13, public announcement shall include disclosure in a
press release reported by the Dow Jones News Service, Associated Press or comparable national news
service or in a document publicly filed by the corporation with the Securities and Exchange
Commission pursuant to Section 13, 14 or 15(d) of the Exchange Act.
(3) Notwithstanding the foregoing provisions of this Section 1.13, a stockholder shall also
comply with all applicable requirements of the Exchange Act and the rules and regulations
thereunder with respect to the matters set forth in this Section 1.13. Nothing in this Section
1.13 shall be deemed to affect any rights (a) of stockholders to request inclusion of proposals or
nominations in the corporations proxy statement pursuant to applicable rules and regulations
promulgated under the Exchange Act or (b) of the holders of any series of Preferred Stock to elect
directors pursuant to any applicable provisions of the certificate of incorporation.
ARTICLE II
Board of Directors
Section 2.1. Number; Qualifications. The Board of Directors shall consist of one or
more members, the number thereof to be determined from time to time by resolution of the Board of
Directors. Directors need not be stockholders.
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Section 2.2. Election; Resignation; Vacancies. The Board of Directors shall
initially consist of the persons named as directors in the certificate of incorporation or elected
by the incorporator of the corporation, and each director so elected shall hold office until the
first annual meeting of stockholders or until his or her successor is duly elected and qualified.
At the first annual meeting of stockholders and at each annual meeting thereafter, the stockholders
shall elect directors each of whom shall hold office for a term of one year or until his or her
successor is duly elected and qualified, subject to such directors earlier death, resignation,
disqualification or removal. Any director may resign at any time upon notice to the corporation.
Unless otherwise provided by law or the certificate of incorporation, any newly created
directorship or any vacancy occurring in the Board of Directors for any cause may be filled by a
majority of the remaining members of the Board of Directors, although such majority is less than a
quorum, or by a plurality of the votes cast at a meeting of stockholders, and each director so
elected shall hold office until the expiration of the term of office of the director whom he or she
has replaced or until his or her successor is elected and qualified.
Section 2.3. Regular Meetings. Regular meetings of the Board of Directors may be
held at such places within or without the State of Delaware and at such times as the Board of
Directors may from time to time determine.
Section 2.4. Special Meetings. Special meetings of the Board of Directors may be
held at any time or place within or without the State of Delaware whenever called by the President,
any Vice President, the Secretary, or by any member of the Board of Directors. Notice of a special
meeting of the Board of Directors shall be given by the person or persons calling the meeting at
least twenty-four hours before the special meeting.
Section 2.5. Telephonic Meetings Permitted. Members of the Board of Directors, or
any committee designated by the Board of Directors, may participate in a meeting thereof by means
of conference telephone or other communications equipment by means of which all persons
participating in the meeting can hear each other, and participation in a meeting pursuant to this
by-law shall constitute presence in person at such meeting.
Section 2.6. Quorum; Vote Required for Action. At all meetings of the Board of
Directors the directors entitled to cast a majority of the votes of the whole Board of Directors
shall constitute a quorum for the transaction of business. Except in cases in which the
certificate of incorporation, these by-laws or applicable law otherwise provides, a majority of the
votes entitled to be cast by the directors present at a meeting at which a quorum is present shall
be the act of the Board of Directors.
Section 2.7. Organization. Meetings of the Board of Directors shall be presided over
by the Chairperson of the Board, if any, or in his or her absence by the Vice Chairperson of the
Board, if any, or in his or her absence by the President, or in their absence by a chairperson
chosen at the meeting. The Secretary shall act as secretary of the meeting, but in his or her
absence the chairperson of the meeting may appoint any person to act as secretary of the meeting.
Section 2.8. Action by Unanimous Consent of Directors. Unless otherwise restricted
by the certificate of incorporation or these by-laws, any action required or permitted to
8
be taken at any meeting of the Board of Directors, or of any committee thereof, may be taken
without a meeting if all members of the Board of Directors or such committee, as the case may be,
consent thereto in writing or by electronic transmission and the writing or writings or electronic
transmissions are filed with the minutes of proceedings of the board or committee in accordance
with applicable law.
ARTICLE III
Committees
Section 3.1. Committees. The Board of Directors may designate one or more
committees, each committee to consist of one or more of the directors of the corporation. The
Board of Directors may designate one or more directors as alternate members of any committee, who
may replace any absent or disqualified member at any meeting of the committee. In the absence or
disqualification of a member of the committee, the member or members thereof present at any meeting
and not disqualified from voting, whether or not he, she or they constitute a quorum, may
unanimously appoint another member of the Board of Directors to act at the meeting in place of any
such absent or disqualified member. Any such committee, to the extent permitted by law and to the
extent provided in the resolution of the Board of Directors, shall have and may exercise all the
powers and authority of the Board of Directors in the management of the business and affairs of the
corporation, and may authorize the seal of the corporation to be affixed to all papers which may
require it.
Section 3.2. Committee Rules. Unless the Board of Directors otherwise provides, each
committee designated by the Board of Directors may make, alter and repeal rules for the conduct of
its business. In the absence of such rules each committee shall conduct its business in the same
manner as the Board of Directors conducts its business pursuant to Article II of these by-laws.
ARTICLE IV
Officers
Section 4.1. Executive Officers; Election; Qualifications; Term of Office; Resignation;
Removal; Vacancies. The Board of Directors shall elect a President and Secretary, and it may,
if it so determines, choose a Chairperson of the Board and a Vice Chairperson of the Board from
among its members. The Board of Directors may also choose one or more Vice Presidents, one or more
Assistant Secretaries, a Treasurer and one or more Assistant Treasurers and such other officers as
it shall from time to time deem necessary or desirable. Each such officer shall hold office until
the first meeting of the Board of Directors after the annual meeting of stockholders next
succeeding his or her election, and until his or her successor is elected and qualified or until
his or her earlier resignation or removal. Any officer may resign at any time upon written notice
to the corporation. The Board of Directors may remove any officer with or without cause at any
time, but such removal shall be without prejudice to the contractual rights of such officer, if
any, with the corporation. Any number of offices may be held by the same person. Any vacancy
occurring in any office of the corporation by death, resignation, removal or otherwise may be
filled for the unexpired portion of the term by the Board of Directors at any regular or special
meeting.
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Section 4.2. Powers and Duties of Executive Officers. The officers of the
corporation shall have such powers and duties in the management of the corporation as may be
prescribed in a resolution by the Board of Directors and, to the extent not so provided, as
generally pertain to their respective offices, subject to the control of the Board of Directors.
The Board of Directors may require any officer, agent or employee to give security for the faithful
performance of his or her duties.
Section 4.3. Appointing Attorneys and Agents; Voting Securities of Other Entities.
Unless otherwise provided by resolution adopted by the Board of Directors, the Chairperson of the
Board, the President or any Vice President may from time to time appoint an attorney or attorneys
or agent or agents of the corporation, in the name and on behalf of the corporation, to cast the
votes which the corporation may be entitled to cast as the holder of stock or other securities in
any other corporation or other entity, any of whose stock or other securities may be held by the
corporation, at meetings of the holders of the stock or other securities of such other corporation
or other entity, or to consent in writing, in the name of the corporation as such holder, to any
action by such other corporation or other entity, and may instruct the person or persons so
appointed as to the manner of casting such votes or giving such consents, and may execute or cause
to be executed in the name and on behalf of the corporation and under its corporate seal or
otherwise, all such written proxies or other instruments as he or she may deem necessary or proper.
Any of the rights set forth in this Section 4.3 which may be delegated to an attorney or agent may
also be exercised directly by the Chairperson of the Board, the President or the Vice President.
ARTICLE V
Stock
Section 5.1. Certificates. The shares of the corporation shall be represented by
certificates, provided that the Board of Directors may provide by resolution or resolutions that
some or all of any or all classes or series of stock shall be uncertificated shares. Any such
resolution shall not apply to shares represented by a certificate until such certificate is
surrendered to the corporation. Every holder of stock represented by certificates shall be
entitled to have a certificate signed by or in the name of the corporation by the Chairperson or
Vice Chairperson of the Board of Directors, if any, or the President or a Vice President, and by
the Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary, of the
corporation certifying the number of shares owned by such holder in the corporation. Any of or all
the signatures on the certificate may be a facsimile. In case any officer, transfer agent or
registrar who has signed or whose facsimile signature has been placed upon a certificate shall have
ceased to be such officer, transfer agent, or registrar before such certificate is issued, it may
be issued by the corporation with the same effect as if such person were such officer, transfer
agent, or registrar at the date of issue.
Section 5.2. Lost, Stolen or Destroyed Stock Certificates; Issuance of New
Certificates. The corporation may issue a new certificate of stock in the place of any
certificate theretofore issued by it, alleged to have been lost, stolen or destroyed, and the
corporation may require the owner of the lost, stolen or destroyed certificate, or such owners
legal representative, to give the corporation a bond sufficient to indemnify it against any claim
that may be made
10
against it on account of the alleged loss, theft or destruction of any such certificate or the
issuance of such new certificate.
ARTICLE VI
Indemnification and Advancement of Expenses
Section 6.1. Right to Indemnification. The corporation shall indemnify and hold
harmless, to the fullest extent permitted by applicable law as it presently exists or may hereafter
be amended, any person (a Covered Person) who was or is made or is threatened to be made a party
or is otherwise involved in any action, suit or proceeding, whether civil, criminal, administrative
or investigative (a proceeding), by reason of the fact that he or she, or a person for whom he or
she is the legal representative, is or was a director or officer of the corporation or, while a
director or officer of the corporation, is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation or of a partnership, joint venture,
trust, enterprise or nonprofit entity, including service with respect to employee benefit plans,
against all liability and loss suffered and expenses (including attorneys fees) reasonably
incurred by such Covered Person. Notwithstanding the preceding sentence, except as otherwise
provided in Section 6.3, the corporation shall be required to indemnify a Covered Person in
connection with a proceeding (or part thereof) commenced by such Covered Person only if the
commencement of such proceeding (or part thereof) by the Covered Person was authorized in the
specific case by the Board of Directors of the corporation.
Section 6.2. Prepayment of Expenses. The corporation shall to the fullest extent not
prohibited by applicable law pay the expenses (including attorneys fees) incurred by a Covered
Person in defending any proceeding in advance of its final disposition, provided,
however, that, to the extent required by law, such payment of expenses in advance of the
final disposition of the proceeding shall be made only upon receipt of an undertaking by the
Covered Person to repay all amounts advanced if it should be ultimately determined that the Covered
Person is not entitled to be indemnified under this Article VI or otherwise.
Section 6.3. Claims. If a claim for indemnification (following the final disposition
of such action, suit or proceeding) or advancement of expenses under this Article VI is not paid in
full within thirty days after a written claim therefor by the Covered Person has been received by
the corporation, the Covered Person may file suit to recover the unpaid amount of such claim and,
if successful in whole or in part, shall be entitled to be paid the expense of prosecuting such
claim. In any such action the corporation shall have the burden of proving that the Covered Person
is not entitled to the requested indemnification or advancement of expenses under applicable law.
Section 6.4. Nonexclusivity of Rights. The rights conferred on any Covered Person by
this Article VI shall not be exclusive of any other rights which such Covered Person may have or
hereafter acquire under any statute, provision of the certificate of incorporation, these by-laws,
agreement, vote of stockholders or disinterested directors or otherwise.
Section 6.5. Other Sources. The corporations obligation, if any, to indemnify or to
advance expenses to any Covered Person who was or is serving at its request as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust, enterprise or
11
nonprofit entity shall be reduced by any amount such Covered Person may collect as
indemnification or advancement of expenses from such other corporation, partnership, joint venture,
trust, enterprise or non-profit enterprise.
Section 6.6. Amendment or Repeal. Any repeal or modification of the foregoing
provisions of this Article VI shall not adversely affect any right or protection hereunder of any
Covered Person in respect of any act or omission occurring prior to the time of such repeal or
modification.
Section 6.7. Other Indemnification and Prepayment of Expenses. This Article VI shall
not limit the right of the corporation, to the extent and in the manner permitted by law, to
indemnify and to advance expenses to persons other than Covered Persons when and as authorized by
appropriate corporate action.
ARTICLE VII
Miscellaneous
Section 7.1. Fiscal Year. The fiscal year of the corporation shall be determined by
resolution of the Board of Directors.
Section 7.2. Seal. The corporate seal shall have the name of the corporation
inscribed thereon and shall be in such form as may be approved from time to time by the Board of
Directors.
Section 7.3. Manner of Notice. Except as otherwise provided herein or permitted by
applicable law, notices to directors and stockholders shall be in writing and delivered personally
or mailed to the directors or stockholders at their addresses appearing on the books of the
corporation. Notice to directors may be given by telecopier, telephone or other means of
electronic transmission.
Section 7.4. Waiver of Notice of Meetings of Stockholders, Directors and Committees.
Any waiver of notice, given by the person entitled to notice, whether before or after the time
stated therein, shall be deemed equivalent to notice. Attendance of a person at a meeting shall
constitute a waiver of notice of such meeting, except when the person attends a meeting for the
express purpose of objecting, at the beginning of the meeting, to the transaction of any business
because the meeting is not lawfully called or convened. Neither the business to be transacted at
nor the purpose of any regular or special meeting of the stockholders, directors, or members of a
committee of directors need be specified in a waiver of notice.
Section 7.5. Form of Records. Any records maintained by the corporation in the
regular course of its business, including its stock ledger, books of account, and minute books, may
be kept on, or by means of, or be in the form of, any information storage device or method,
provided that the records so kept can be converted into clearly legible paper form within a
reasonable time.
12
Section 7.6. Amendment of By-Laws. These by-laws may be altered, amended or
repealed, and new by-laws made, by the Board of Directors, but the stockholders may make additional
by-laws and may alter and repeal any by-laws whether adopted by them or otherwise.
13
EXHIBIT 10.3 LICENSE AGREEMENT
Exhibit 10.3
AMENDMENT NO. 1
The
License Agreement between Brookhaven Science Associates LLC. and Catalyst
Pharmaceutical Partners, Inc., effective as of April 3, 2006, is hereby amended, effective April 3,
2006 as follows:
In Article I Definitions, sub-paragraph 12 of paragraph (a), Patent Rights, is replaced in
its entirety as follows:
12. Foreign patents and foreign patent applications corresponding to U.S. patents and
patent applications identified in paragraph 1 11 above.
In Article XIII Notices, paragraph (a), the contact information for Licensor is replaced as
follows:
For Licensor:
Christine Brakel, Licensing Specialist
Office of Intellectual Property and Sponsored Research
Brookhaven National Laboratory
Building No. 475D
P.O. Box 5000
Upton, New York 11973-5000
Telephone: 631-344-7134
Fax: 631-344-3729
E-mail: brakel@bnl.gov
In Article XIII Notices, paragraph (b), the delivery details for mailing checks is replaced
as follows:
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CHECK MAILED TO:
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Manager |
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Office of Intellectual Property and Sponsored Research |
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Brookhaven National Laboratory |
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Bldg. 475D, P.O. Box 5000 |
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Upton, NY 11973-5000 |
All other terms and conditions remain in full force and effect.
LICENSOR:
BROOKHAVEN SCIENCE ASSOCIATES, LLC.
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By |
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/s/ Lori-Anne Neiger |
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Lori-Anne Neiger
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Title
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Senior Patent Counsel |
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Office of Intellectual Property |
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Date |
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April 3, 2006 |
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LICENSOR:
CATALYST PHARMACEUTICAL PARTNERS, INC.
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By |
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/s/ Patrick J. McEnany |
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Patrick J. McEnany
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Title
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Chief Executive Officer |
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Date |
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April 3, 2006 |
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Patrick J. McEnany
Chief Executive Officer |
April 3, 2006
Ms. Margaret C. Bogosian
Manager
Brookhaven National Laboratory
Office of Intellectual Property & Sponsored Research
Building 475D
Upton, NY 11973-5000
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Re:
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License Agreement between Brookhaven Science Associates (BSA) and Catalyst
Pharmaceutical Partners |
Dear Peg:
Enclosed please find one fully executed original of the amended License Agreement between
Brookhaven Science Associates and Catalyst Pharmaceutical Partners.
Thank you for your continued support.
Best regards,
Patrick J. McEnany
Chief Executive Officer
Enclosures
220
Miracle Mile, Suite 234 Coral Gables, Florida 33134
Phone (305) 529-2522 Fax (305)
529-0933
www.catalystpharma.com
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Office of Intellectual Property & Sponsored Research
Building 475D
P.O. Box 5000
Upton, NY 11973-5000
Phone 631 344-7338
Fax 631 344-3729
bogosian@bnl.gov |
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managed by Brookhaven
Science Associates
for the U.S. Department of Energy |
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www.bnl.gov |
March 31,
2006
Mr. Patrick McEnany
Chief Executive Officer
Catalyst Pharmaceutical Partners
220 Miracle Mile, Suite 234
Coral Gables, FL 33134
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Re:
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License Agreement Between Brookhaven Science Associates (BSA) and Catalyst
Pharmaceutical Partners |
Dear Pat:
In pursuant to my e-mail dated 3/31/06, please find duplicate originals of the subject license
agreement between BSA and Catalyst for your approval. Kindly execute both originals at your
earliest convenience, and return one fully executed original to me.
If you have any questions, please feel free to contact me.
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Sincerely, |
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/s/ Margaret C. Bogosian
Margaret C. Bogosian
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Manager |
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MCB: gc
Enclosures
LICENSE AGREEMENT
This Agreement is effective as of the latest date of signing below (Effective Date) and is
by and between Brookhaven Science Associates LLC, (Licensor), operator of Brookhaven National
Laboratory, Upton, New York 11973, under contract with the U.S. Department of Energy, and Catalyst
Pharmaceutical Partners, Inc., (Licensee) having a principal place of business at 220 Miracle
Mile, Suite 234, Coral Gables, FL 33134.
Licensor represents that it is the owner by assignment of all rights, title and interest in
the patent properties covering the use of gaba-vinyl gaba (GVG) in the treatment of addiction and
addiction-related behavior.
Licensor represents that it has the right to grant licenses under said patent properties,
subject to a non-exclusive, non-transferable, irrevocable, paid-up license heretofore granted to
the U.S. Government to practice or have practiced the invention(s) covered by said patent
properties for or on behalf of the United States Government and further represents that it will
provide to Licensee, upon request, accurate and complete copies of said patent properties.
Licensor desires to have said patent properties utilized in the public interest and is willing
to grant this license on the terms and conditions set forth herein.
Licensee desires to secure an exclusive worldwide license with the right to sublicense under
said patent properties on the terms and conditions set forth herein.
Accordingly, in consideration of the premises and the mutual covenants of this
Agreement, the parties hereto agree as follows:
I DEFINITIONS
(a) The term Patent Rights shall mean:
1. BSA Docket No. BSA 98-26 United States Patent No. 6,057,368 issued May
2, 2000 in the names of Dewey, et al. entitled Treatment of Addiction and Addiction Related
Behavior, and any reissue thereof;
2. BSA Docket No. BSA 00-33 United States Patent No. 6,323,239 issued
November 27, 2001 in the names of Dewey, et al. entitled Treatment of Addiction to Ethanol
and Addictive-Related Behavior, and any reissue thereof;
3. BSA Docket No. BSA 99-02 United States Patent No. 6,828,349 issued
December 7, 2004 in the names of Dewey, ct al. entitled Treatment of Addiction and Addiction
Related Behavior, and any reissue thereof,
4. BSA Docket No. BSA 99-03 United States Patent No. 6,541,520 issued April
1, 2003 in the names of Dewey, et al. entitled Treatment of Addiction and Addiction Related
Behavior, and any reissue thereof,
5. BSA Docket No. BSA 99-18 United States Patent No. 6,593,367 issued July
15, 2003 in the names of Dewey, et al. entitled Treatment of Addiction and Addiction Related
Behavior, and any reissue thereof,
6. BSA Docket No. BSA 00-26 United States No. 6,395,783 May 28, 2002 in
the names of Dewey, et al. entitled Treatment of PCP Addiction and PCP Addiction-Related
Behavior and any reissue thereof,
7.
BSA Docket No. BSA 00-38 United States Patent No. 6,462,084 issued
October 8, 2002 in the names of Dewey, et al. entitled Novel Treatment for Obsessive-
Compulsive Disorders, and any reissue thereof,
8. BSA Docket No. BSA 02-12 United States No. 6,939,876 issued September 6,
2005 in the names of Dewey, et al. entitled Prevention of Addiction in Pain Management, and
any reissue thereof,
9. BSA Docket No. BSA 03-02 United States Patent No. 6,713,497 issued
March 30, 2004 in the names of Charles Ashby entitled Use of Vitamin B6 to Mitigate Visual
Field Defects Associated with the Use of Gabaergic Drugs in Mammals, and any reissue thereof,
10. BSA Docket No. BSA 03-05 United States Patent Application Serial No.
10/446,285 filed May 27, 2004 in the name of Charles Ashby entitled Use of Anti-Glaucoma
Drugs to Treat Visual Defects Associated with the Use of a GABAergic Agent, and any
continuations, continuations-in-part, or divisional of said applications, and any patents
reissue of
patents that issued thereon,
11. BSA Docket No. BSA 04-09 United States Patent Application Serial No.
10/776,108 filed February 10, 2004 in the name of Charles Ashby entitled Use of Vitamin B6 to
Mitigate Visual Field Defects Associated with the Use of Gabaergic Drugs in Mammals, and
any continuations, continuations-in-part, or divisional of said applications, and any patents
reissue of patents that issued thereon,
12.
Foreign patents and foreign patent applications corresponding to U.S. patent applications identified in paragraphs 2-11 above.
(b) The term Valid Claim means and includes a claim contained in the Patent Rights which has
not expired, which has not been held invalid or unenforceable by final decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
- 3 -
the time allowed for appeal, and which has not been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise.
(c) The term Licensed Product shall mean any product that incorporates, is covered by,
is made in whole or in part by, or is used according to the inventions covered by any Valid
Claim
in the Patent Rights.
(d) The term Licensed Process means any process the practice of which is covered
by any of the claims in the Patent Rights.
(e) The term Field of Use means the medical application in humans of gamma-vinylGABA (also identified as GVG or vigabatrin).
(f) The term Term means the period of this License Agreement and shall run from
the Effective Date of this Agreement to the end of the term of the last to expire patent in
the Patent Rights licensed hereunder.
II GRANT
Subject to the rights of the U.S. Government, defined in Public Law 98-620 and the related
implementing regulations at 37 CFR Part 401, Licensor hereby grants to Licensee an exclusive
worldwide license with the right to sublicense within the Field of Use under the Patent Rights to
make, have made, use, and/or sell Licensed Products and to practice the Licensed Process.
III REIMBURSEMENT OF LICENSORS PATENT COSTS
(a) As partial consideration for the granting of this license, Licensee will reimburse
Licensor for all reasonable and customary expenses incurred by Licensor prior to September 30, 2005
in connection with the filing, prosecution, and maintenance of all patents and patent
- 4 -
applications included in the Patent Rights. These expenses total $69,352.00, which amount shall be
payable by Licensee to Licensor in six (6) equal payments during each of the six (6) months
immediately following the date upon which Licensee submits its NDA to the U.S. Food and Drug
Administration (FDA) for the use of GVG in the treatment of human cocaine addiction.
(b) As partial consideration for the granting of this license, Licensee will reimburse
Licensor for all reasonable and customary expenses incurred by Licensor subsequent to
September 30, 2005 in connection with the filing, prosecution, and maintenance of all patents
and patent applications included in the Patent Rights. Licensor will submit periodic invoices
to
Licensee covering such expenses with Licensors first invoice to be submitted to Licensee
within
sixty (60) days of FDA regulatory approval to sell any Licensed
Product to practice a Licensed
Process. Licensee will reimburse Licensor within thirty (30) days of receipt of each invoice.
(c) During the Term Licensor shall consult on an ongoing basis with the Licensee, or
Licensees designated intellectual properly representative, respecting the prosecution,
maintenance and protection of the Patent Rights and shall give reasonable consideration to the
views of Licensee with respect thereto.
IV REPORTS AND ROYALTIES
(a) Commencing in the calendar year following FDA regulatory approval to sell any
Licensed Product and/or to practice a Licensed Process, Licensee agrees to make written
reports
to Licensor annually, within sixty (60) days after the first day of each January during the
Term,
and, as of such date, stating in each such report the particulars of the business conducted by
Licensee during the preceding twelve (12) month period under this license Agreement
(b) Concurrently with the making of each such report required by paragraph (a) of this
- 5 -
Article IV,
Licensee will pay to Licensor a lump sum royalty according to the following schedule:
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i. |
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For the calendar year in which the FDA approves Licensees NDA for the
use of GVG in the treatment of human cocaine addiction $100,000.00,
due by
December 31st of said year; |
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ii. |
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For calendar years two
and three after FDA approval of Licensees NDA
for the use of GVG in the treatment of human cocaine addiction
$250,000.00 each year due by December 31st of each year;
and |
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iii. |
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For the remaining years covered by the term of this
agreement
$500,000.00 each year, due by
December 31st of each year. |
(c) Licensee agrees to make a written report to Licensor within sixty (60) days after
the date of any termination of this Agreement, stating in such report the business particulars
up to
such date of termination which were not previously reported to Licensor. Concurrently with the
making of this report, Licensee will pay to Licensor the pro-rated share of the appropriate
lump
sum royalty due under paragraph (b) above.
(d) All monies payable hereunder shall be paid in United States Dollars.
V SUBLICENSES
(a) The
grant under Article II above includes the right to grant sublicenses. Any
sublicense granted by Licensee shall be subject to the terms and conditions of this Agreement,
including the insurance requirement in Article VII hereof, and shall contain an express provision
to that effect. No sublicense shall relieve Licensee of any of its obligations under this
Agreement. Licensee agrees to forward to Licensor a fully executed copy of each sublicense
- 6 -
agreement it enters into within thirty (30) days after execution thereof.
(b) Licensee
agrees to include in its reports required in Article IV above an accounting of all consideration received by Licensee from its sublicensees. Licensee agrees to
pay Licensor, in addition to all of the amounts provided for in Article IV above, twenty
percent
(20%) of all consideration of any nature, including, for example, license fees, earned
royalties,
and minimum royalties, received by Licensee from its sublicensees.
(c) Upon the termination of this Agreement for any cause, any and all existing
sublicenses hereunder shall thereupon automatically terminate. This shall be made a condition
of
any sublicense that may be granted by Licensee.
VI AUDITING
(a) Licensee agrees to keep for a period of three years the records used to prepare the
reports required by Article IV hereof. Such records shall be in sufficient detail to enable
the
royalties and licensing fees payable hereunder by Licensee to be clearly and fully determined
Licensee further agrees to permit such records to be examined from time to time to the extent
necessary to verify the reports provided for in Article IV hereof, such examination to be made
at
the expense of Licensor by an auditor appointed by Licensor who will be acceptable to
Licensee,
which acceptance shall not be unreasonably withheld, or at the option and expense of Licensee,
by an independent Certified Public Accountant who shall be appointed by Licensee and who
shall be acceptable to Licensor, which acceptance shall not be unreasonably withheld.
(b) Licensor agrees to maintain in confidence the information reported to it in
Licensees annual reports and any confidential information it obtains through its audit
rights.
Licensor will neither disclose this information outside of its organization nor use this
information
- 7 -
for any purpose other than collection of royalties or license fees from Licensee under this
Agreement.
(c) Licensee
agrees that the confidentiality and use provisions of this Article shall not
apply to the following:
(1) any information which appears in printed publications or which otherwise
is or becomes generally known in the trade other than through the fault of Licensor;
(2) any information which Licensor can show by written records was in its
possession prior to the disclosure hereunder;
(3) any information which comes into the possession of Licensor without
covenants of secrecy from another party who is under no obligation to Licensee to maintain the
confidentiality of the information; or
(4) disclosure of any information when required by law, including disclosure
required by applicable disclosure rules promulgated by the U.S. Securities and Exchange
Commission.
VII
DISCLAIMER, INDEMNIFICATION, HOLD HARMLESS AND INSURANCE
(a) Except with respect to the representations and warranties set forth by Licensor in
the preamble to this License Agreement, Licensor makes no representation or warranty, either
expressed or implied, with respect to the License herein granted other than that Licensor has
the
right to grant said license.
(b) Nothing in this Agreement shall be construed as:
(1) a warranty or representation by Licensor as to the validity or scope of any Patent
Rights;
- 8 -
(2) a warranty or representation that any product made, used, sold or otherwise
disposed of or any method practiced under any license granted under this Agreement is or will
be
free from infringement or claims of infringement of patents, copyrights or any other property
right of third parties; or
(3) granting by implication, estoppel or otherwise any licenses or rights under
patents or other property rights of Licensor other than said Patent Rights, regardless
of
whether such patents are dominant or subordinate to any Patent Rights.
(c) Licensor shall not be liable for any injury, losses or damages, including special or
consequential damages or losses incurred by Licensee, nor for claims for such damages, losses
or
other injuries asserted or levied against Licensee, arising out of Licensees practice of the
Grant
set forth in Article II of this Agreement. Licensee shall indemnify and hold harmless Licensor
and the U.S. government from any claims, actions, judgements or awards arising out of
Licensees practice of the Grant set forth in Article II, or out of Licensees manufacture,
use, sale
or disposition of Licensed Products.
(d) Licensee shall, from and after the date of approval by the FDA of Licensees
application to commence Phase I/II Clinical Trials involving Licensed Products, have in effect
and shall maintain a liability insurance policy in an amount of at least One Million U.S.
Dollars
($1,000,000.00) coverage for claims arising out of the manufacture and use of Licensed
Products,
and the Practice of Licensed Process and Licensee shall have Licensor designated as a named
insured in said policy at no expense to Licensor. Licensee shall at the time this requirement
becomes effective, deliver to Licensor a Certificate of Insurance evidencing such liability
insurance policy and showing Licensor as a named insured.
- 9 -
(e) Licensee shall, from and after the date of approval by the FDA of Licensees
application to commence Phase III Clinical Trials involving Licensed Products, have in effect and
shall thereafter maintain throughout the life of this Agreement and for five (5) years after this
Agreement is terminated, a liability insurance policy in an amount of at least Five Million U.S.
Dollars ($5,000,000.00) coverage for claims arising out of the manufacture, use or sale of Licensed
Products, and Licensee shall have Licensor designated as a named insured in said policy, at no
expense to Licensor. Licensee shall, prior to commencement of said Phase III Clinical Trials,
deliver to Licensor a Certificate of Insurance evidencing such liability insurance policy and
showing Licensor as a named insured. At each fifth anniversary of the effective date for the
$5,000,000.00 insurance requirement, Licensor shall review the insurance coverage required by this
Article and adjust the coverage, as necessary, to maintain the face value of the coverage within
five percent (5%) of the stated $5,000,000.00 adjusted in constant dollars using the effective date
of the $5,000,000.00 insurance requirement as the starting base for any such adjustment.
VIII INFRINGEMENT OF LICENSORS PATENT RIGHTS BY THIRD PARTIES
(a) Should Licensor or Licensee become aware of any infringement or alleged
infringement in the United States, its territories and possessions, of any of the Patent
Rights, that
party shall promptly notify the other party in writing of the name and address of the alleged
infringer and of the alleged acts of infringement, and provide any available evidence of the
alleged acts of infringement.
(b) Neither Licensor nor Licensee shall be obligated to institute suit against any
alleged infringer of any of the Patent Rights.
- 10 -
(c) Licensee shall have the right to bring legal action against an alleged infringer of
any of the Patent Rights in its own name or in the joint name of the Licensee and Licensor. In
the event that Licensee elects to initiate an infringement action in its own name, or in the
joint
name of Licensee and Licensor, any and all expenses, judgments or sanctions incurred in
connection with such legal action shall be borne solely by Licensee. During the term of any
such
legal action, Licensee may withhold from any royalties due to Licensor an amount equal to the
expenses incurred by Licensee in pursuing the infringement action. Upon conclusion of any such
legal action, Licensee shall retain for itself, any and all monies or other benefits derived
from
such legal action, and shall immediately pay to Licensor any withheld royalties, that covered
expenses that were recovered by Licensee.
(d) Licensor and Licensee hereby agree to cooperate with each other in the
prosecution of any legal infringement action or settlement discussions and each agrees to
provide
the other with all pertinent data and evidence which may be helpful in the prosecution of such
action of which it may have knowledge or which may be readily available to it without
incurring
substantial expense.
(e) Should Licensee commence a suit under the provisions of this Article and
thereafter elect to abandon this suit, it shall give timely notice to the Licensor who may, if
it so
desires, continue prosecution of such suit, provided however that the sharing of expenses and
any
recovery in such continued suit shall be as agreed upon between Licensor and Licensee.
(f) If, at any time during this Agreement, Licensor or Licensee shall be unable to
uphold the validity of any of the Patent Rights against any alleged infringer, Licensee shall
not
have or assert any damage claim or a claim for refund or reimbursement against Licensor.
- 11 -
Excluded from this paragraph (f) shall be Licensors liability to indemnify Licensee for the
breach of those representations and warranties recited in the Preamble to this License Agreement.
IX SUCCESSOR RIGHTS
(a) The obligations of Licensee hereunder, including the obligations to make reports and pay
royalties, shall run in favor of the successors, assigns or other legal representatives of
Licensor.
(b) Licensees rights under this Agreement and the license herein granted shall not be
assigned for the benefit of creditors of Licensee or otherwise, nor shall such rights or license
pass to any receiver in bankruptcy of Licensees assets, except for a person or corporation
succeeding to the entire business and good will of Licensee in the manufacture and sale of Licensed
Products as the result of a sale, consolidation, reorganization or otherwise, provided such person
or corporation shall, without delay, accept in writing the provisions of this Agreement and agree
to become in all respects bound thereby in the place and stead of Licensee. Licensees rights
under this Agreement and the license herein granted shall not be otherwise transferred without the
written consent of Licensor.
X UNITED STATES GOVERNMENT EXPORT CONTROL REGULATIONS
(a) The Export Control Regulations of the U.S. Department of Commerce prohibit, except under a
special validated license, the exportation from the United States of technical data relating to
certain commodities listed in the Regulations, unless the exporter has received certain written
assurance from the foreign importer. In order to facilitate the exchange of technical information
under this Agreement, Licensee therefor hereby gives its assurance to Licensor that it will comply
with all of the requirements of the U.S. Export Control Regulations.
- 12 -
(b) A final judicial determination of a violation of the U.S. Export Control laws or
regulations by Licensee shall constitute grounds for Licensor, in its sole discretion, to terminate
this license agreement. Failure to obtain any needed export control license may result in criminal
liability under the United States law.
XI TERM AND TERMINATION
(a) Subject to the termination rights set forth in Article XV(e) and this Article XI, this
License Agreement shall commence on the Effective Date and shall run through the Term.
(b) If Licensee shall at any time default in the payment of any license fee or royalty or in
the making of any report hereunder, or shall commit any breach of any covenant herein contained,
except for the diligence requirements set forth in Article XV, and shall fail to remedy any such
default or breach within sixty (60) days after written notice thereof by Licensor, then Licensor
may, at its option, terminate the license and all other rights herein granted, by giving notice to
Licensee in writing to such effect.
(c) This License Agreement may be terminated:
(1) by Licensee any time after two years from the Effective Date of this Agreement. Under
this subparagraph (c), Licensee shall have the right to terminate the prospective effect of
the license hereunder by written notice given to the Licensor at least six (6) months prior to
the date when such termination is to become effective.
(d) Any termination or expiration of this License Agreement shall not relieve Licensee from
its obligations under Article IV hereof to make a terminal report and maintain records, or from its
liability for payment of royalties or other License fees hereunder prior to the date of such
termination or expiration, and shall not prejudice the right of Licensor to recover any
- 13 -
royalty or other sums or consideration due or accrued at the time of such termination or expiration
and shall not prejudice any cause of action or claim of Licensor accrued on account of any breach
or default by Licensee.
(e) Any termination or expiration of this Agreement shall not prejudice the right of Licensor
to conduct a final audit of the records of Licensee in accordance with the provisions of Article IV
hereof.
XII ADVERTISING
Neither the granting of the license herein granted by Licensor nor the acceptance of the
license fee or royalties hereunder by Licensor shall constitute Licensors approval of, or
acquiescence in, advertising or other business practices of Licensee or Licensees sublicensees,
nor an approval of or acquiescence in any use of the corporate name of Licensor, or any use of the
name Brookhaven National Laboratory, or any use of the name(s) of the inventors of the Patent
Rights licensed, or of the names of any agencies of the U.S. Government, in connection with the
manufacture, advertising, use or sale of Licensed Products, and Licensor hereby expressly reserves
all rights of actions with respect thereto.
XIII NOTICES
(a) Any notice pursuant to this Agreement shall be sufficiently made or given on the date of
mailing if sent to a party by certified mail, postage prepaid, addressed to it at its address
below:
For Licensor:
Margaret C. Bogosian, Manager
Office of Intellectual Property and Sponsored Research
Brookhaven National Laboratory
Building No. 475D
- 14 -
P.O. Box 5000
Upton, New York 11973-5000
For Licensee:
Patrick J. McEnany, President
Catalyst Pharmaceutical Partners, Inc.
Suite 234
220 Miracle Mile
Coral Gables, FL 33134
Alternatively,
such notices may be delivered to such other address or addresses as either Licensor or Licensee, respectively, may later establish by written notice to the other.
(b) Any payments due from Licensee to Licensor hereunder shall be made as follows:
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CHECK PAYABLE TO:
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Brookhaven Science Associates, LLC |
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CHECK MAILED TO:
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Margaret C. Bogosian |
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Manager |
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Office of Intellectual Property
and Sponsored Research |
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Brookhaven National Laboratory |
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Bldg. 475D, P.O. Box 5000 |
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Upton, NY 11973-5000 |
XIV APPLICABLE LAW
This Agreement shall be construed, interpreted and applied in accordance with the laws of the
United States and of the State of New York.
XV LICENSEES DILIGENCE
(a) Commencing at the time the FDA accepts Licensees IND for the use of GVG in the treatment
of human cocaine addiction and ending at the time the FDA grants approval to sell any Licensed
Product, and/or practice Licensed Process, the Licensee shall consult with Licensor by telephone
not less frequently than quarterly with regard to drug development steps taken and
- 15 -
progress made toward the objective of gaining FDA marketing approval for any Licensed Product.
In this regard, Licensee shall make reasonable effort to be responsive to Licensors inquiries
regarding such drug development activities.
(b) Within six (6) months of the date the FDA accepts Licensees IND for the use of GVG in the
treatment of human cocaine addiction for a study other than a phase I (drug interaction study),
Licensee will procure sufficient GVG or Sabril drug and placebo and provide such drug and placebo
to the clinical sites conducting the clinical trials under Licensees IND.
(c) If Licensee fails to meet any or all of the diligence requirements set forth in paragraphs
(a) and (b) above, Licensor shall provide Licensee with written notice of such failure.
Licensee will have three months after receipt of said notice to cure said failure. Licensor will
extend said cure period for an additional three months upon the presentation by Licensee of
reasonable evidence explaining its inability to effect a cure within the initial three month
period.
(d) Failure of Licensee to cure a failure within the applicable cure period pursuant to
paragraph (c) above shall be grounds for Licensor to terminate the license granted in this License
Agreement. Licensor can terminate this Agreement for Licensees failure to meet the diligence
requirements by delivery to Licensee of a Termination Notice.
XVI PREFERENCE FOR UNITED STATES INDUSTRY
Consistent with the provisions of 35 USC 204, Licensee agrees that any products embodying
technology covered by the Patent Rights or produced through the use of technology covered by the
Patent Rights that are to be marketed in the United States will be substantially manufactured in
the United States.
- 16 -
XVII ENTIRE UNDERSTANDING
This Agreement amends and restates the License Agreement between the parties dated March 20,
2002, (the Old Agreement) which Old Agreement is
superceded by the terms of this Agreement as of
the Effective Date. This Agreement constitutes the entire understanding between the parties hereto
with respect to the subject matter hereof, and any modification of this Agreement shall be in
writing and shall be signed by a duly authorized representative of each party. There are no
understandings, representations or warranties with respect to the subject matter hereof, except as
herein expressly set forth, and no rights are granted hereunder except as expressly set forth
herein.
The parties hereto have duly executed this Agreement.
LICENSOR:
BROOKHAVEN SCIENCE ASSOCIATES, LLC
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By
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/s/ Margaret C. Bogosian |
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Margaret C. Bogosian |
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Title Manager, Office of Intellectual Property
&
Sponsored Research |
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Date 3/31/06 |
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LICENSEE:
CATALYST PHARMACEUTICAL PARTNERS, INC.
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By
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/s/ Patrick J. McEnany
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Title C.E.O. |
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Date 4/3/06 |
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- 17 -
EXHIBIT 10.4 STOCK OPTION AGREEMENTS/PATRICK J. MC
Exhibit 10.4
NON-QUALIFIED STOCK OPTION AGREEMENT
THIS
AGREEMENT, entered into on July 1, 2002 (the Grant
Date), is made by and between Catalyst Pharmaceutical Partners, Inc., a Florida corporation
(Catalyst) and Patrick J. McEnany, an employee of Catalyst, hereinafter referred to as
Optionee:
WHEREAS, Catalyst is desirous of increasing the incentive of the Optionee whose contributions
are important to the continued success of Catalyst.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and
valuable consideration, receipt of which is hereby acknowledged, Catalyst hereby grants the
Optionee the Non-qualified Stock Option provided for herein, upon the following terms and
conditions:
ARTICLE I
DEFINITIONS
Whenever the following terms are used in this Agreement, they shall have the meaning specified
below unless the context clearly indicates to the contrary. The masculine pronoun shall include
the feminine and neuter, and the singular the plural, where the context so indicates.
Section 1.1 Board
Board shall mean the Board of Directors of Catalyst.
Section 1.2 Cause
Cause shall mean (i) failure or refusal of the Optionee to perform the duties and
responsibilities that Catalyst requires to be performed by him, (ii) gross negligence or willful
misconduct by the Optionee in the performance of his duties, (iii) commission by the Optionee of an
act of dishonesty affecting Catalyst, or the commission of an act constituting common law fraud or
a felony, or (iv) the Optionees commission of an act (other than the good faith exercise of his
business judgment in the exercise of his responsibilities) resulting in material damages to
Catalyst; provided, however, that if the Optionee and Catalyst have entered into an employment
agreement which defines cause for purposes of such agreement, cause shall be defined in
accordance with such agreement. The Committee, in its sole and absolute discretion, shall
determine whether a termination of employment is for Cause.
Section 1.3 Common Stock
Common Stock shall mean the common stock of Catalyst, par value $.01 per share.
Section 1.4 Code
Code shall mean the Internal Revenue Code of 1986, as amended.
Section 1.5 Committee
Committee shall mean the Compensation Committee of the Board, or another committee of the
Board, to administer the grant of Options.
Section 1.6 Director
Director shall mean a member of the Board.
Section 1.7 Exchange Act
Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
Section 1.8 Fair Market Value
Fair Market Value of a share of Common Stock as of a given date shall be (a) the closing
price of a share of Common Stock on the principal exchange on which shares of Common Stock are then
trading, if any (or as reported on any composite index which includes such principal exchange), on
the trading day previous to such date, or if shares of Common Stock were not traded on the trading
day previous to such date, then on the next preceding date on which a trade occurred; (b) if Common
Stock is not traded on an exchange but is quoted on The Nasdaq National Market, The Nasdaq SmallCap
Market or a successor quotation system, the last sales price for the Common Stock on the trading
day previous to such date as reported by The Nasdaq National Market, The Nasdaq SmallCap Market or
such successor quotation system; or (c) if Common Stock is not publicly traded on an exchange and
not quoted on The Nasdaq National Market, The Nasdaq SmallCap Market or a successor quotation
system, the fair market value of a share of Common Stock as established by the Committee acting in
good faith.
Section 1.9 Grant Date
Grant Date shall mean November 1, 2002.
Section 1.10 Option
Option shall mean the non-qualified stock option to purchase Common Stock of Catalyst
granted under this Agreement.
Section 1.11 Rule 16b-3
Rule 16b-3 shall mean that certain Rule 16b-3 under the Exchange Act, as such Rule may be
amended from time to time.
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Section 1.12 Securities Act
Securities Act shall mean the Securities Act of 1933, as amended.
Section 1.13 Stock Option Administrator
Stock Option Administrator shall mean the officer designated, from time to time, by the
Committee to serve as the Stock Option Administrator and any agents of the Stock Option
Administrator.
Section 1.14 Termination of Employment
Termination of Employment shall mean the time when the employee-employer relationship
between the Optionee and Catalyst is terminated for any reason, with or without Cause, including,
but not by way of limitation, a termination by resignation, discharge, death, disability or
retirement; but excluding (i) terminations where there is a simultaneous reemployment or continuing
employment of the Optionee by Catalyst, (ii) at the discretion of the Committee, terminations which
result in a temporary severance of the employee-employer relationship, and (iii) at the discretion
of the Committee, terminations which are followed by the simultaneous establishment of a consulting
relationship by Catalyst with the former employee. The Committee, in its absolute discretion,
shall determine the effect of all matters and questions relating to Termination of Employment,
including, but not by way of limitation, the question of whether a Termination of Employment
resulted from a discharge for Cause, and all questions of whether a particular leave of absence
constitutes a Termination of Employment. Notwithstanding any other provision of this Agreement,
Catalyst has an absolute and unrestricted right to terminate the Optionees employment at any time
for any reason whatsoever, with or without Cause, except to the extent expressly provided otherwise
in writing.
ARTICLE II
GRANT OF OPTION
Section 2.1 Grant of Option
In consideration of the Optionees agreement to remain in the employ of Catalyst and for other
good and valuable consideration, on the date hereof Catalyst irrevocably grants to the Optionee the
option to purchase any part or all of an aggregate of 250,000 shares of its Common Stock upon the
terms and conditions set forth in this Agreement.
Section 2.2 Purchase Price
The purchase price of the shares of Common Stock covered by the Option shall be $1.00 per
share without commission or other charge.
3
Section 2.3 Consideration to Catalyst
In consideration of the granting of this Option by Catalyst, the Optionee agrees to render
faithful and efficient services to Catalyst, with such duties and responsibilities as Catalyst
shall from time to time prescribe. Nothing in this Agreement shall confer upon the Optionee any
right to continue in the employ of Catalyst, or as a director of Catalyst, or shall interfere with
or restrict in any way the rights of Catalyst, which are hereby expressly reserved, to discharge
the Optionee at any time for any reason whatsoever, with or without Cause.
ARTICLE III
PERIOD OF EXERCISABILITY
Section 3.1 Commencement of Exercisability
(a) Subject to subsection (b) and Sections 3.3 and 3.4, the Option shall become exercisable in
cumulative installments as follows:
(i) The first installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the six month anniversary of the Grant
Date.
(ii) The second installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the eighteen month anniversary of the
Grant Date.
(iii) The third installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the twenty-four month anniversary of
the Grant Date.
(b) Except as provided in Section 3.4(b) below, no portion of the Option which is
unexercisable at Termination of Employment shall thereafter become exercisable.
Section 3.2 Duration of Exercisability
The installments provided for in Section 3.1 are cumulative. Each such installment which
becomes exercisable pursuant to Section 3.1 shall remain exercisable until it becomes unexercisable
under Section 3.3.
Section 3.3 Expiration of Option
The Option may not be exercised to any extent by anyone after the first to occur of the
following events:
(a) The expiration of ten (10) years from the date the Option was granted; or
4
(b) The expiration of ninety (90) days from the date of the Optionees Termination of
Employment, unless such Termination of Employment results from his death, his disability (within
the meaning of Section 22(e)(3) of the Code) or his being discharged for Cause; or
(c) The date specified in Section 3.3(a) above in the event that the Optionees Termination of
Employment results from his death; or
(d) The expiration of one (1) year from the date of the Optionees Termination of Employment
in the event such Termination of Employment results from his disability (within the meaning of
Section 22(e)(3) of the Code); or
(e) The date of Optionees Termination of Employment, as applicable, in the event that the
Termination of Employment results from his being discharged for Cause.
Section 3.4 Acceleration of Exercisability
In the event of the Optionees Termination of Employment due to the Optionees death,
notwithstanding any vesting schedule provided for hereunder, this Option shall become immediately
vested and, to the extent applicable, exercisable for such period of time specified in Section
3.3(a).
ARTICLE IV
EXERCISE OF OPTION
Section 4.1 Persons Eligible to Exercise
During the lifetime of the Optionee, only the Optionee, or any person to whom the Option may
be transferred pursuant to Section 6.2 below, may exercise the Option or any portion thereof.
After the death of the Optionee, any exercisable portion of the Option may, prior to the time when
the Option becomes unexercisable under Section 3.3, be exercised by his personal representative or
by any person empowered to do so under the deceased Optionees will or under the then applicable
laws of descent and distribution.
Section 4.2 Partial Exercise
Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be
exercised in whole or in part at any time prior to the time when the Option or portion thereof
becomes unexercisable under Section 3.3; provided, however, that each partial
exercise shall be for not less than one hundred (100) shares of Common Stock (or the minimum
installment set forth in Section 3.1, if a smaller number of shares of Common Stock) and shall be
for whole shares only.
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Section 4.3 Manner of Exercise
The Option, or any exercisable portion thereof, may be exercised solely by delivery to the
Stock Option Administrator or an agent of the Stock Option Administrator, as designated by the
Committee from time to time, of all of the following prior to the time when the Option or such
portion becomes unexercisable under Section 3.3:
(a) A written notice complying with the applicable rules established by the Committee stating
that the Option, or a portion thereof, is exercised. The notice shall be signed by the Optionee or
other person then entitled to exercise the Option or such portion; and
(b) (i) payment in cash or in cash equivalents equal to the product of the per share
exercise price times the number of shares of Common Stock with respect to which the option
or portion is being exercised (the Aggregate Exercise Price);
(ii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, through the tender to Catalyst of shares of Common Stock,
which shares shall be valued, for purposes of determining the extent to which the Exercise
Price has been paid thereby, at their Fair Market Value on the date of exercise;
(iii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by delivering a written direction to Catalyst that the Option
be exercised pursuant to a cashless exercise/sale procedure (pursuant to which funds to
pay for exercise of the Option are delivered to Catalyst by a broker upon receipt of stock
certificates from Catalyst) or a cashless exercise/loan procedure (pursuant to which the
participants would obtain a margin loan from a broker to fund the exercise) through a
licensed broker acceptable to Catalyst whereby the stock certificate or certificates for the
shares of Common Stock for which the Option is exercised will be delivered to such broker as
the agent for the individual exercising the Option and the broker will deliver to Catalyst
cash (or cash equivalents acceptable to Catalyst) equal to the purchase price for the shares
of Common Stock purchased pursuant to the exercise of the Option plus the amount (if any) of
federal and other taxes that Catalyst may, in its judgment, be required to withhold with
respect to the exercise of the Option;
(iv) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by the delivery of a promissory note of the participant to
Catalyst on such terms as the Committee shall specify in its sole and absolute discretion;
or
(v) by a combination of the methods described in clauses (i), (ii), (iii) and (iv).
(c) A bona fide written representation and agreement, in a form satisfactory to the Committee,
signed by the Optionee or other person then entitled to exercise such Option or portion,
stating that the shares of Common Stock are being acquired for his own account, for investment
and without any present intention of distributing or reselling said shares or any of
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them except as
may be permitted under the Securities Act and then applicable rules and regulations thereunder, and
that the Optionee or other person then entitled to exercise such Option or portion will indemnify
Catalyst against and hold it free and harmless from any loss, damage, expense or liability
resulting to Catalyst if any sale or distribution of the shares of Common Stock by such person is
contrary to the representation and agreement referred to above. The Committee may, in its absolute
discretion, take whatever additional actions it deems appropriate to insure the observance and
performance of such representation and agreement and to effect compliance with the Securities Act
and any other federal or state securities laws or regulations. Without limiting the generality of
the foregoing, the Committee may require an opinion of counsel acceptable to it to the effect that
any subsequent transfer of shares of Common Stock acquired on an Option exercise does not violate
the Securities Act, and may issue stop-transfer orders covering such shares. Share certificates
evidencing stock issued on exercise of this Option shall bear an appropriate legend referring to
the provisions of this subsection (c) and the agreements herein. The written representation and
agreement referred to in the first sentence of this subsection (c) shall, however, not be required
if the shares of Common Stock to be issued pursuant to such exercise have been registered under the
Securities Act, and such registration is then effective in respect of such shares; and
(d) Full payment to Catalyst (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option; and
(e) In the event the Option or any portion thereof shall be exercised pursuant to Section 4.1
by any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
Section 4.4 Conditions to Issuance of Stock Certificates
The shares of Common Stock deliverable upon the exercise of the Option, or any portion
thereof, may be either previously authorized but unissued shares or issued shares which have then
been reacquired by Catalyst. Such shares of Common Stock shall be fully paid and nonassessable.
Catalyst shall not be required to issue or deliver any certificate or certificates for shares of
stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of
the following conditions:
(a) The admission of such shares of Common Stock to listing on all stock exchanges on which
such class of stock is then listed; and
(b) The completion of any registration or other qualification of such shares of Common Stock
under any state or federal law or under rulings or regulations of the Securities and Exchange
Commission or of any other governmental regulatory body, which the Committee shall, in its absolute
discretion, deem necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
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(d) The receipt by Catalyst of full payment for such shares of Common Stock, including payment
of all amounts which, under federal, state or local tax law, Catalyst (or other employer
corporation) is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
Section 4.5 Rights as Shareholder
The holder of the Option shall not be, nor have any of the rights or privileges of, a
shareholder of Catalyst in respect of any shares of Common Stock purchasable upon the exercise of
any part of the Option unless and until certificates representing such shares of Common Stock shall
have been issued by Catalyst to such holder.
ARTICLE V
EFFECT OF CHANGES IN CAPITALIZATION
Section 5.1 Recapitalization
If the outstanding shares of Common Stock of Catalyst are increased or decreased or changed
into or exchanged for a different number or kind of shares or other securities of Catalyst by
reason of any recapitalization, reclassification, reorganization (other than as described in
Section 5.2 below), stock split, reverse split, combination of shares, exchange of shares, stock
dividend or other distribution payable in capital stock of Catalyst, or other increase or decrease
in such shares effected without receipt of consideration by Catalyst, an appropriate and
proportionate adjustment shall be made by the Committee in the number and kind of shares of Common
Stock issuable upon exercise of this Option, and in the purchase price per share of this Option.
Section 5.2 Reorganization or Change in Control
In the event of a Reorganization (as defined below) of Catalyst or a Change in Control (as
defined below) of Catalyst, this Option shall become immediately vested and, to the extent
applicable, exercisable for such period of time specified in Section 3.3(a). For purposes of this
Agreement a Reorganization of an entity shall be deemed to occur if such entity is a party to a
merger, consolidation, reorganization, or other business combination with one or more entities in
which said entity is not the surviving entity, if such entity disposes of substantially all of its
assets, or if such entity is a party to a spin-off, split-off, split-up or similar transaction;
provided, however, that the transaction shall not be a Reorganization if Catalyst, any parent or
any subsidiary is the surviving entity. For purposes of this Agreement, a Change in Control
shall be deemed to occur if any person or group of persons shall acquire direct or indirect beneficial
ownership (whether as a result of stock
ownership, revocable or irrevocable proxies or otherwise) of securities of an entity, pursuant to
one or more transactions, such that after consummation and as a result of such transaction, such
person has direct or indirect beneficial
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ownership of 50% or more of the total combined voting
power of the Common Stock. For purposes of this Agreement, a person shall mean any person,
corporation, partnership, joint venture or other entity or any group (as such term is defined for
purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act)),
other than a parent or subsidiary, and beneficial ownership shall be determined in accordance
with Rule 13d-3 under the Exchange Act.
Section 5.3 Dissolution or Liquidation
Upon the dissolution or liquidation of Catalyst, this Option shall terminate. In the event of
any termination of this Option under this Section 5.3, Optionee shall have the right, immediately
prior to the occurrence of such termination and during such reasonable period as the Committee in
its sole discretion shall determine and designate, to exercise this Option in whole or in part,
whether or not this Option was otherwise exercisable at the time such termination occurs and
without regard to any vesting or other limitation on exercise imposed pursuant to Article III
above.
Section 5.4 Adjustments
Adjustments under this Article V related to stock or securities of Catalyst shall be made by
the Committee, whose determination in that respect shall be final, binding, and conclusive. No
fractional shares of Common Stock or units of other securities shall be issued pursuant to any such
adjustment, and any fractions resulting from any such adjustment shall be eliminated in each case
by rounding downward to the nearest whole share or unit.
Section 5.5 No Limitations
The grant of this Option hereunder shall not affect or limit in any way the right or power of
Catalyst to make adjustments, reclassifications, reorganizations or changes of its capital or
business structure or to merge, consolidate, dissolve or liquidate, or to sell or transfer all or
any part of its business or assets.
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ARTICLE VI
OTHER PROVISIONS
Section 6.1 Administration
All actions taken and all interpretations and determinations made by the Committee in good
faith shall be final and binding upon the Optionee, Catalyst and all other interested persons. No
member of the Committee shall be personally liable for any action, determination or interpretation
made in good faith with respect to the Option. In its absolute discretion, the Board may at any
time and from time to time exercise any and all rights and duties of the Committee under the Plan
and this Agreement except with respect to matters which under Rule 16b-3 or Section 162(m) of the
Code, or any regulations or rules issued thereunder, are required to be determined in the sole
discretion of the Committee.
Section 6.2 Option Not Transferable
This Option shall not be assignable or transferable by the Optionee, other than by will or the
laws of descent and distribution; provided, however, that this Option may be transferred or
assigned to (i) family members or entities (including trusts) established for the benefit of the
Optionee or the Optionees family members or (ii) any other person, as permitted by applicable
securities law. Any Option assigned or transferred pursuant to this Section 6.2 shall continue to
be subject to the same terms and conditions as were applicable to the Option immediately before the
transfer; provided, however, that any Option transferred for value may not be exercised under any
Registration Statement on Form S-8 and upon exercise of such transferred Option the holder will
only be entitled to receive shares of restricted stock that have not been registered under the
Securities Act of 1933.
Section 6.3 Shares to Be Reserved
Catalyst shall at all times during the term of the Option reserve and keep available such
number of shares of Common Stock as will be sufficient to satisfy the requirements of this
Agreement.
Section 6.4 Notices
Any notice to be given under the terms of this Agreement to Catalyst shall be addressed to
Catalyst in care of the officer designated as the Stock Option Administrator from time to time, and
any notice to be given to the Optionee shall be addressed to him at the address given beneath his
signature hereto. By a notice given pursuant to this Section 6.4, either party may hereafter
designate a different address for notices to be given to him. Any notice which is required to be
given to the Optionee shall, if the Optionee is then deceased, be given to the Optionees personal
representative if such representative has previously informed Catalyst of his status and address by
written notice under this Section 6.4. Any notice shall be deemed duly given when enclosed in a
properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a
post office or branch post office regularly maintained by the United
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States Postal Service;
provided, however, that any notice to be
given by the Optionee relating to the exercise of the Option or any portion thereof shall be
deemed duly given upon receipt by the Stock Option Administrator or his office.
Section 6.5 Titles
Titles are provided herein for convenience only and are not to serve as a basis for
interpretation or construction of this Agreement.
Section 6.6 Construction
This Agreement shall be administered, interpreted and enforced under the internal laws of the
State of Florida without regard to conflicts of laws thereof.
Section 6.7 Conformity to Securities Laws
The Optionee acknowledges that this Agreement is intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and
rules promulgated by the Securities and Exchange Commission thereunder, including, without
limitation, the applicable exemptive conditions of Rule 16b-3. Notwithstanding anything herein to
the contrary, the Option is granted and may be exercised, only in such a manner as to conform to
such laws, rules and regulations. To the extent permitted by applicable law, this Agreement shall
be deemed amended to the extent necessary to conform to such laws, rules and regulations.
Section 6.8 Amendments
This Agreement may be amended without the consent of the Optionee provided that such amendment
would not impair any rights of the Optionee under this Agreement. No amendment of this Agreement
shall, without the consent of the Optionee, impair any rights of the Optionee under this Agreement.
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IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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By: |
/s/ Hubert Huckel
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Name: |
Hubert Huckel |
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Title: |
Chairman |
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/s/ Patrick J. McEnany
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Optionee |
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NON-QUALIFIED STOCK OPTION AGREEMENT
THIS AGREEMENT, entered into on March 4, 2005 (the Grant Date), is made by and between
Catalyst Pharmaceutical Partners, Inc., a Florida corporation (Catalyst) and Patrick J. McEnany,
an employee of Catalyst, hereinafter referred to as Optionee:
WHEREAS, Catalyst is desirous of increasing the incentive of the Optionee whose contributions
are important to the continued success of Catalyst.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and
valuable consideration, receipt of which is hereby acknowledged, Catalyst hereby grants the
Optionee the Non-qualified Stock Option provided for herein, upon the following terms and
conditions:
ARTICLE I
DEFINITIONS
Whenever the following terms are used in this Agreement, they shall have the meaning specified
below unless the context clearly indicates to the contrary. The masculine pronoun shall include
the feminine and neuter, and the singular the plural, where the context so indicates.
Section 1.1 Board
Board shall mean the Board of Directors of Catalyst.
Section 1.2 Cause
Cause shall mean (i) failure or refusal of the Optionee to perform the duties and
responsibilities that Catalyst requires to be performed by him, (ii) gross negligence or willful
misconduct by the Optionee in the performance of his duties, (iii) commission by the Optionee of an
act of dishonesty affecting Catalyst, or the commission of an act constituting common law fraud or
a felony, or (iv) the Optionees commission of an act (other than the good faith exercise of his
business judgment in the exercise of his responsibilities) resulting in material damages to
Catalyst; provided, however, that if the Optionee and Catalyst have entered into an employment
agreement which defines cause for purposes of such agreement, cause shall be defined in
accordance with such agreement. The Committee, in its sole and absolute discretion, shall
determine whether a termination of employment is for Cause.
Section 1.3 Common Stock
Common Stock shall mean the common stock of Catalyst, par value $.01 per share.
Section 1.4 Code
Code shall mean the Internal Revenue Code of 1986, as amended.
Section 1.5 Committee
Committee shall mean the Compensation Committee of the Board, or another committee of the
Board, to administer the grant of Options.
Section 1.6 Director
Director shall mean a member of the Board.
Section 1.7 Exchange Act
Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
Section 1.8 Fair Market Value
Fair Market Value of a share of Common Stock as of a given date shall be (a) the closing
price of a share of Common Stock on the principal exchange on which shares of Common Stock are then
trading, if any (or as reported on any composite index which includes such principal exchange), on
the trading day previous to such date, or if shares of Common Stock were not traded on the trading
day previous to such date, then on the next preceding date on which a trade occurred; (b) if Common
Stock is not traded on an exchange but is quoted on The Nasdaq National Market, The Nasdaq SmallCap
Market or a successor quotation system, the last sales price for the Common Stock on the trading
day previous to such date as reported by The Nasdaq National Market, The Nasdaq SmallCap Market or
such successor quotation system; or (c) if Common Stock is not publicly traded on an exchange and
not quoted on The Nasdaq National Market, The Nasdaq SmallCap Market or a successor quotation
system, the fair market value of a share of Common Stock as established by the Committee acting in
good faith.
Section 1.9 Grant Date
Grant Date shall mean March 4, 2005.
Section 1.10 Option
Option shall mean the non-qualified stock option to purchase Common Stock of Catalyst
granted under this Agreement.
Section 1.11 Rule 16b-3
Rule 16b-3 shall mean that certain Rule 16b-3 under the Exchange Act, as such Rule may be
amended from time to time.
2
Section 1.12 Securities Act
Securities Act shall mean the Securities Act of 1933, as amended.
Section 1.13 Stock Option Administrator
Stock Option Administrator shall mean the officer designated, from time to time, by the
Committee to serve as the Stock Option Administrator and any agents of the Stock Option
Administrator.
Section 1.14 Termination of Employment
Termination of Employment shall mean the time when the employee-employer relationship
between the Optionee and Catalyst is terminated for any reason, with or without Cause, including,
but not by way of limitation, a termination by resignation, discharge, death, disability or
retirement; but excluding (i) terminations where there is a simultaneous reemployment or continuing
employment of the Optionee by Catalyst, (ii) at the discretion of the Committee, terminations which
result in a temporary severance of the employee-employer relationship, and (iii) at the discretion
of the Committee, terminations which are followed by the simultaneous establishment of a consulting
relationship by Catalyst with the former employee. The Committee, in its absolute discretion,
shall determine the effect of all matters and questions relating to Termination of Employment,
including, but not by way of limitation, the question of whether a Termination of Employment
resulted from a discharge for Cause, and all questions of whether a particular leave of absence
constitutes a Termination of Employment. Notwithstanding any other provision of this Agreement,
Catalyst has an absolute and unrestricted right to terminate the Optionees employment at any time
for any reason whatsoever, with or without Cause, except to the extent expressly provided otherwise
in writing.
ARTICLE II
GRANT OF OPTION
Section 2.1 Grant of Option
In consideration of the Optionees agreement to remain in the employ of Catalyst and for other
good and valuable consideration, on the date hereof Catalyst irrevocably grants to the Optionee the
option to purchase any part or all of an aggregate of 250,000 shares of its Common Stock upon the
terms and conditions set forth in this Agreement.
Section 2.2 Purchase Price
The purchase price of the shares of Common Stock covered by the Option shall be $1.00 per
share without commission or other charge.
3
Section 2.3 Consideration to Catalyst
In consideration of the granting of this Option by Catalyst, the Optionee agrees to render
faithful and efficient services to Catalyst, with such duties and responsibilities as Catalyst
shall from time to time prescribe. Nothing in this Agreement shall confer upon the Optionee any
right to continue in the employ of Catalyst, or as a director of Catalyst, or shall interfere with
or restrict in any way the rights of Catalyst, which are hereby expressly reserved, to discharge
the Optionee at any time for any reason whatsoever, with or without Cause.
ARTICLE III
PERIOD OF EXERCISABILITY
Section 3.1 Commencement of Exercisability
The Option shall vest and become exercisable on the Grant Date.
Section 3.2 Duration of Exercisability
The Option shall remain exercisable until it becomes unexercisable under Section 3.3.
Section 3.3 Expiration of Option
The Option may not be exercised to any extent by anyone after the first to occur of the
following events:
(a) The expiration of ten (10) years from the date the Option was granted; or
(b) The expiration of ninety (90) days from the date of the Optionees Termination of
Employment, unless such Termination of Employment results from his death, his disability (within
the meaning of Section 22(e)(3) of the Code) or his being discharged for Cause; or
(c) The date specified in Section 3.3(a) above in the event that the Optionees Termination of
Employment results from his death; or
(d) The expiration of one (1) year from the date of the Optionees Termination of Employment
in the event such Termination of Employment results from his disability (within the meaning of
Section 22(e)(3) of the Code); or
(e) The date of Optionees Termination of Employment, as applicable, in the event that the
Termination of Employment results from his being discharged for Cause.
4
Section 3.4 Acceleration of Exercisability
In the event of the Optionees Termination of Employment due to the Optionees death,
notwithstanding any vesting schedule provided for hereunder, this Option shall become immediately
vested and, to the extent applicable, exercisable for such period of time specified in Section
3.3(a).
ARTICLE IV
EXERCISE OF OPTION
Section 4.1 Persons Eligible to Exercise
During the lifetime of the Optionee, only the Optionee, or any person to whom the Option may
be transferred pursuant to Section 6.2 below, may exercise the Option or any portion thereof.
After the death of the Optionee, any exercisable portion of the Option may, prior to the time when
the Option becomes unexercisable under Section 3.3, be exercised by his personal representative or
by any person empowered to do so under the deceased Optionees will or under the then applicable
laws of descent and distribution.
Section 4.2 Partial Exercise
Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be
exercised in whole or in part at any time prior to the time when the Option or portion thereof
becomes unexercisable under Section 3.3; provided, however, that each partial
exercise shall be for not less than one hundred (100) shares of Common Stock (or the minimum
installment set forth in Section 3.1, if a smaller number of shares of Common Stock) and shall be
for whole shares only.
Section 4.3 Manner of Exercise
The Option, or any exercisable portion thereof, may be exercised solely by delivery to the
Stock Option Administrator or an agent of the Stock Option Administrator, as designated by the
Committee from time to time, of all of the following prior to the time when the Option or such
portion becomes unexercisable under Section 3.3:
(a) A written notice complying with the applicable rules established by the Committee stating
that the Option, or a portion thereof, is exercised. The notice shall be signed by the Optionee or
other person then entitled to exercise the Option or such portion; and
(b) (i) payment in cash or in cash equivalents equal to the product of the per share
exercise price times the number of shares of Common Stock with respect to which the option
or portion is being exercised (the Aggregate Exercise Price);
(ii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, through the tender to Catalyst of shares of
Common Stock, which shares shall be valued, for purposes of determining the extent to
5
which the Exercise Price has been paid thereby, at their Fair Market Value on the date of
exercise;
(iii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by delivering a written direction to Catalyst that the Option
be exercised pursuant to a cashless exercise/sale procedure (pursuant to which funds to
pay for exercise of the Option are delivered to Catalyst by a broker upon receipt of stock
certificates from Catalyst) or a cashless exercise/loan procedure (pursuant to which the
participants would obtain a margin loan from a broker to fund the exercise) through a
licensed broker acceptable to Catalyst whereby the stock certificate or certificates for the
shares of Common Stock for which the Option is exercised will be delivered to such broker as
the agent for the individual exercising the Option and the broker will deliver to Catalyst
cash (or cash equivalents acceptable to Catalyst) equal to the purchase price for the shares
of Common Stock purchased pursuant to the exercise of the Option plus the amount (if any) of
federal and other taxes that Catalyst may, in its judgment, be required to withhold with
respect to the exercise of the Option;
(iv) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by the delivery of a promissory note of the participant to
Catalyst on such terms as the Committee shall specify in its sole and absolute discretion;
or
(v) by a combination of the methods described in clauses (i), (ii), (iii) and (iv).
(c) A bona fide written representation and agreement, in a form satisfactory to the Committee,
signed by the Optionee or other person then entitled to exercise such Option or portion, stating
that the shares of Common Stock are being acquired for his own account, for investment and without
any present intention of distributing or reselling said shares or any of them except as may be
permitted under the Securities Act and then applicable rules and regulations thereunder, and that
the Optionee or other person then entitled to exercise such Option or portion will indemnify
Catalyst against and hold it free and harmless from any loss, damage, expense or liability
resulting to Catalyst if any sale or distribution of the shares of Common Stock by such person is
contrary to the representation and agreement referred to above. The Committee may, in its absolute
discretion, take whatever additional actions it deems appropriate to insure the observance and
performance of such representation and agreement and to effect compliance with the Securities Act
and any other federal or state securities laws or regulations. Without limiting the generality of
the foregoing, the Committee may require an opinion of counsel acceptable to it to the effect that
any subsequent transfer of shares of Common Stock acquired on an Option exercise does not violate
the Securities Act, and may issue stop-transfer orders covering such shares. Share certificates
evidencing stock issued on exercise of this Option shall bear an appropriate legend referring to
the provisions of this subsection (c) and the agreements herein. The written representation and
agreement referred to in the first sentence of this subsection (c) shall, however, not be required
if the shares of Common Stock to be issued pursuant to such exercise have
been registered under the Securities Act, and such registration is then effective in respect
of such shares; and
6
(d) Full payment to Catalyst (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option; and
(e) In the event the Option or any portion thereof shall be exercised pursuant to Section 4.1
by any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
Section 4.4 Conditions to Issuance of Stock Certificates
The shares of Common Stock deliverable upon the exercise of the Option, or any portion
thereof, may be either previously authorized but unissued shares or issued shares which have then
been reacquired by Catalyst. Such shares of Common Stock shall be fully paid and nonassessable.
Catalyst shall not be required to issue or deliver any certificate or certificates for shares of
stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of
the following conditions:
(a) The admission of such shares of Common Stock to listing on all stock exchanges on which
such class of stock is then listed; and
(b) The completion of any registration or other qualification of such shares of Common Stock
under any state or federal law or under rulings or regulations of the Securities and Exchange
Commission or of any other governmental regulatory body, which the Committee shall, in its absolute
discretion, deem necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by Catalyst of full payment for such shares of Common Stock, including payment
of all amounts which, under federal, state or local tax law, Catalyst (or other employer
corporation) is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
Section 4.5 Rights as Shareholder
The holder of the Option shall not be, nor have any of the rights or privileges of, a
shareholder of Catalyst in respect of any shares of Common Stock purchasable upon the exercise of
any part of the Option unless and until certificates representing such shares of Common Stock shall
have been issued by Catalyst to such holder.
ARTICLE V
EFFECT OF CHANGES IN CAPITALIZATION
7
Section 5.1 Recapitalization
If the outstanding shares of Common Stock of Catalyst are increased or decreased or changed
into or exchanged for a different number or kind of shares or other securities of Catalyst by
reason of any recapitalization, reclassification, reorganization (other than as described in
Section 5.2 below), stock split, reverse split, combination of shares, exchange of shares, stock
dividend or other distribution payable in capital stock of Catalyst, or other increase or decrease
in such shares effected without receipt of consideration by Catalyst, an appropriate and
proportionate adjustment shall be made by the Committee in the number and kind of shares of Common
Stock issuable upon exercise of this Option, and in the purchase price per share of this Option.
Section 5.2 Reorganization or Change in Control
In the event of a Reorganization (as defined below) of Catalyst or a Change in Control (as
defined below) of Catalyst, the Committee may in its sole and absolute discretion, provide that
this Option terminates, provided however, that Optionee shall have the right, immediately prior to
the occurrence of such Reorganization or Change in Control and during such reasonable period as the
Committee in its sole discretion shall determine and designate, to exercise any vested portion of
this Option in whole or in part. In the event that the Committee does not terminate this Option
upon a Reorganization of Catalyst then this Option shall upon exercise thereafter entitle the
Optionee to such number of shares of Common Stock or other securities or property to which a holder
of shares of Common Stock would have been entitled to upon such Reorganization. For purposes of
this Agreement a Reorganization of an entity shall be deemed to occur if such entity is a party
to a merger, consolidation, reorganization, or other business combination with one or more entities
in which said entity is not the surviving entity, if such entity disposes of substantially all of
its assets, or if such entity is a party to a spin-off, split-off, split-up or similar transaction;
provided, however, that the transaction shall not be a Reorganization if Catalyst, any parent or
any subsidiary is the surviving entity. For purposes of this Agreement, a Change in Control
shall be deemed to occur if any person or group of persons shall acquire direct or indirect
beneficial ownership (whether as a result of stock ownership, revocable or irrevocable proxies or
otherwise) of securities of an entity, pursuant to one or more transactions, such that after
consummation and as a result of such transaction, such person has direct or indirect beneficial
ownership of 50% or more of the total combined voting power of the Common Stock. For purposes of
this Agreement, a person shall mean any person, corporation, partnership, joint venture or other
entity or any group (as such term is defined for purposes of Section 13(d) of the Securities
Exchange Act of 1934, as amended (the Exchange Act)), other than a parent or subsidiary, and
beneficial ownership shall be determined in accordance with Rule 13d-3 under the Exchange Act.
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Section 5.3 Dissolution or Liquidation
Upon the dissolution or liquidation of Catalyst, this Option shall terminate. In the event of
any termination of this Option under this Section 5.3, Optionee shall have the right, immediately
prior to the occurrence of such termination and during such reasonable period as the Committee in
its sole discretion shall determine and designate, to exercise this Option in whole or in part,
whether or not this Option was otherwise exercisable at the time such termination occurs and
without regard to any vesting or other limitation on exercise imposed pursuant to Article III
above.
Section 5.4 Adjustments
Adjustments under this Article V related to stock or securities of Catalyst shall be made by
the Committee, whose determination in that respect shall be final, binding, and conclusive. No
fractional shares of Common Stock or units of other securities shall be issued pursuant to any such
adjustment, and any fractions resulting from any such adjustment shall be eliminated in each case
by rounding downward to the nearest whole share or unit.
Section 5.5 No Limitations
The grant of this Option hereunder shall not affect or limit in any way the right or power of
Catalyst to make adjustments, reclassifications, reorganizations or changes of its capital or
business structure or to merge, consolidate, dissolve or liquidate, or to sell or transfer all or
any part of its business or assets.
ARTICLE VI
OTHER PROVISIONS
Section 6.1 Administration
All actions taken and all interpretations and determinations made by the Committee in good
faith shall be final and binding upon the Optionee, Catalyst and all other interested persons. No
member of the Committee shall be personally liable for any action, determination or interpretation
made in good faith with respect to the Option. In its absolute discretion, the Board may at any
time and from time to time exercise any and all rights and duties of the Committee under the Plan
and this Agreement except with respect to matters which under Rule 16b-3 or Section 162(m) of the
Code, or any regulations or rules issued thereunder, are required to be determined in the sole
discretion of the Committee.
Section 6.2 Option Not Transferable
This Option shall not be assignable or transferable by the Optionee, other than by will or the
laws of descent and distribution; provided, however, that this Option may be transferred or
assigned to (i) family members or entities (including trusts) established for the benefit of the
Optionee or the
Optionees family members or (ii) any other person, as permitted
9
by applicable securities law.
Any Option assigned or transferred pursuant to this Section 6.2 shall continue to be subject to
the same terms and conditions as were applicable to the Option immediately before the transfer;
provided, however, that any Option transferred for value may not be exercised under any
Registration Statement on Form S-8 and upon exercise of such transferred Option the holder will
only be entitled to receive shares of restricted stock that have not been registered under the
Securities Act of 1933.
Section 6.3 Shares to Be Reserved
Catalyst shall at all times during the term of the Option reserve and keep available such
number of shares of Common Stock as will be sufficient to satisfy the requirements of this
Agreement.
Section 6.4 Notices
Any notice to be given under the terms of this Agreement to Catalyst shall be addressed to
Catalyst in care of the officer designated as the Stock Option Administrator from time to time, and
any notice to be given to the Optionee shall be addressed to him at the address given beneath his
signature hereto. By a notice given pursuant to this Section 6.4, either party may hereafter
designate a different address for notices to be given to him. Any notice which is required to be
given to the Optionee shall, if the Optionee is then deceased, be given to the Optionees personal
representative if such representative has previously informed Catalyst of his status and address by
written notice under this Section 6.4. Any notice shall be deemed duly given when enclosed in a
properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a
post office or branch post office regularly maintained by the United States Postal Service;
provided, however, that any notice to be given by the Optionee relating to the
exercise of the Option or any portion thereof shall be deemed duly given upon receipt by the Stock
Option Administrator or his office.
Section 6.5 Titles
Titles are provided herein for convenience only and are not to serve as a basis for
interpretation or construction of this Agreement.
Section 6.6 Construction
This Agreement shall be administered, interpreted and enforced under the internal laws of the
State of Florida without regard to conflicts of laws thereof.
Section 6.7 Conformity to Securities Laws
The Optionee acknowledges that this Agreement is intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and
rules promulgated by the Securities and Exchange Commission thereunder, including, without
limitation, the applicable exemptive conditions of Rule 16b-3. Notwithstanding anything herein to
the contrary, the Option is granted and may be exercised, only in such a manner as to conform to
such laws, rules and regulations. To the extent permitted
10
by applicable law, this Agreement shall be deemed
amended to the extent necessary to conform to such laws, rules and regulations.
Section 6.8 Amendments
This Agreement may be amended without the consent of the Optionee provided that such amendment
would not impair any rights of the Optionee under this Agreement. No amendment of this Agreement
shall, without the consent of the Optionee, impair any rights of the Optionee under this Agreement.
IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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By: |
/s/ Patrick J. McEnany
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Name: |
Patrick J. McEnany |
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Title: |
President and CEO |
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/s/ Patrick J. McEnany
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Optionee |
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11
EXHIBIT 10.5 STOCK OPTION AGREEMENTS/HUBERT HUCKEL
Exhibit 10.5
NON-QUALIFIED STOCK OPTION AGREEMENT
THIS
AGREEMENT, entered into on July 1, 2002 (the Grant
Date), is made by and between Catalyst Pharmaceutical Partners, Inc., a Florida corporation
(Catalyst) and Hubert E. Huckel, M.D., an employee of Catalyst, hereinafter referred to as
Optionee:
WHEREAS, Catalyst is desirous of increasing the incentive of the Optionee whose contributions
are important to the continued success of Catalyst.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and
valuable consideration, receipt of which is hereby acknowledged, Catalyst hereby grants the
Optionee the Non-qualified Stock Option provided for herein, upon the following terms and
conditions:
ARTICLE I
DEFINITIONS
Whenever the following terms are used in this Agreement, they shall have the meaning specified
below unless the context clearly indicates to the contrary. The masculine pronoun shall include
the feminine and neuter, and the singular the plural, where the context so indicates.
Section 1.1 Board
Board shall mean the Board of Directors of Catalyst.
Section 1.2 Cause
Cause shall mean (i) failure or refusal of the Optionee to perform the duties and
responsibilities that Catalyst requires to be performed by him, (ii) gross negligence or willful
misconduct by the Optionee in the performance of his duties, (iii) commission by the Optionee of an
act of dishonesty affecting Catalyst, or the commission of an act constituting common law fraud or
a felony, or (iv) the Optionees commission of an act (other than the good faith exercise of his
business judgment in the exercise of his responsibilities) resulting in material damages to
Catalyst; provided, however, that if the Optionee and Catalyst have entered into an employment
agreement which defines cause for purposes of such agreement, cause shall be defined in
accordance with such agreement. The Committee, in its sole and absolute discretion, shall
determine whether a termination of employment is for Cause.
Section 1.3 Common Stock
Common Stock shall mean the common stock of Catalyst, par value $.01 per share.
Section 1.4 Code
Code shall mean the Internal Revenue Code of 1986, as amended.
Section 1.5 Committee
Committee shall mean the Compensation Committee of the Board, or another committee of the
Board, to administer the grant of Options.
Section 1.6 Director
Director shall mean a member of the Board.
Section 1.7 Exchange Act
Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
Section 1.8 Fair Market Value
Fair Market Value of a share of Common Stock as of a given date shall be (a) the closing
price of a share of Common Stock on the principal exchange on which shares of Common Stock are then
trading, if any (or as reported on any composite index which includes such principal exchange), on
the trading day previous to such date, or if shares of Common Stock were not traded on the trading
day previous to such date, then on the next preceding date on which a trade occurred; (b) if Common
Stock is not traded on an exchange but is quoted on The Nasdaq National Market, The Nasdaq SmallCap
Market or a successor quotation system, the last sales price for the Common Stock on the trading
day previous to such date as reported by The Nasdaq National Market, The Nasdaq SmallCap Market or
such successor quotation system; or (c) if Common Stock is not publicly traded on an exchange and
not quoted on The Nasdaq National Market, The Nasdaq SmallCap Market or a successor quotation
system, the fair market value of a share of Common Stock as established by the Committee acting in
good faith.
Section 1.9 Grant Date
Grant Date shall mean November 1, 2002.
Section 1.10 Option
Option shall mean the non-qualified stock option to purchase Common Stock of Catalyst
granted under this Agreement.
Section 1.11 Rule 16b-3
Rule 16b-3 shall mean that certain Rule 16b-3 under the Exchange Act, as such Rule may be
amended from time to time.
2
Section 1.12 Securities Act
Securities Act shall mean the Securities Act of 1933, as amended.
Section 1.13 Stock Option Administrator
Stock Option Administrator shall mean the officer designated, from time to time, by the
Committee to serve as the Stock Option Administrator and any agents of the Stock Option
Administrator.
Section 1.14 Termination of Employment
Termination of Employment shall mean the time when the employee-employer relationship
between the Optionee and Catalyst is terminated for any reason, with or without Cause, including,
but not by way of limitation, a termination by resignation, discharge, death, disability or
retirement; but excluding (i) terminations where there is a simultaneous reemployment or continuing
employment of the Optionee by Catalyst, (ii) at the discretion of the Committee, terminations which
result in a temporary severance of the employee-employer relationship, and (iii) at the discretion
of the Committee, terminations which are followed by the simultaneous establishment of a consulting
relationship by Catalyst with the former employee. The Committee, in its absolute discretion,
shall determine the effect of all matters and questions relating to Termination of Employment,
including, but not by way of limitation, the question of whether a Termination of Employment
resulted from a discharge for Cause, and all questions of whether a particular leave of absence
constitutes a Termination of Employment. Notwithstanding any other provision of this Agreement,
Catalyst has an absolute and unrestricted right to terminate the Optionees employment at any time
for any reason whatsoever, with or without Cause, except to the extent expressly provided otherwise
in writing.
ARTICLE II
GRANT OF OPTION
Section 2.1 Grant of Option
In consideration of the Optionees agreement to remain in the employ of Catalyst and for other
good and valuable consideration, on the date hereof Catalyst irrevocably grants to the Optionee the
option to purchase any part or all of an aggregate of 250,000 shares of its Common Stock upon the
terms and conditions set forth in this Agreement.
Section 2.2 Purchase Price
The purchase price of the shares of Common Stock covered by the Option shall be $1.00 per
share without commission or other charge.
3
Section 2.3 Consideration to Catalyst
In consideration of the granting of this Option by Catalyst, the Optionee agrees to render
faithful and efficient services to Catalyst, with such duties and responsibilities as Catalyst
shall from time to time prescribe. Nothing in this Agreement shall confer upon the Optionee any
right to continue in the employ of Catalyst, or as a director of Catalyst, or shall interfere with
or restrict in any way the rights of Catalyst, which are hereby expressly reserved, to discharge
the Optionee at any time for any reason whatsoever, with or without Cause.
ARTICLE III
PERIOD OF EXERCISABILITY
Section 3.1 Commencement of Exercisability
(a) Subject to subsection (b) and Sections 3.3 and 3.4, the Option shall become exercisable in
cumulative installments as follows:
(i) The first installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the six month anniversary of the Grant
Date.
(ii) The second installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the eighteen month anniversary of the
Grant Date.
(iii) The third installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the twenty-four month anniversary of
the Grant Date.
(b) Except as provided in Section 3.4(b) below, no portion of the Option which is
unexercisable at Termination of Employment shall thereafter become exercisable.
Section 3.2 Duration of Exercisability
The installments provided for in Section 3.1 are cumulative. Each such installment which
becomes exercisable pursuant to Section 3.1 shall remain exercisable until it becomes unexercisable
under Section 3.3.
Section 3.3 Expiration of Option
The Option may not be exercised to any extent by anyone after the first to occur of the
following events:
(a) The expiration of ten (10) years from the date the Option was granted; or
4
(b) The expiration of ninety (90) days from the date of the Optionees Termination of
Employment, unless such Termination of Employment results from his death, his disability (within
the meaning of Section 22(e)(3) of the Code) or his being discharged for Cause; or
(c) The date specified in Section 3.3(a) above in the event that the Optionees Termination of
Employment results from his death; or
(d) The expiration of one (1) year from the date of the Optionees Termination of Employment
in the event such Termination of Employment results from his disability (within the meaning of
Section 22(e)(3) of the Code); or
(e) The date of Optionees Termination of Employment, as applicable, in the event that the
Termination of Employment results from his being discharged for Cause.
Section 3.4 Acceleration of Exercisability
In the event of the Optionees Termination of Employment due to the Optionees death,
notwithstanding any vesting schedule provided for hereunder, this Option shall become immediately
vested and, to the extent applicable, exercisable for such period of time specified in Section
3.3(a).
ARTICLE IV
EXERCISE OF OPTION
Section 4.1 Persons Eligible to Exercise
During the lifetime of the Optionee, only the Optionee, or any person to whom the Option may
be transferred pursuant to Section 6.2 below, may exercise the Option or any portion thereof.
After the death of the Optionee, any exercisable portion of the Option may, prior to the time when
the Option becomes unexercisable under Section 3.3, be exercised by his personal representative or
by any person empowered to do so under the deceased Optionees will or under the then applicable
laws of descent and distribution.
Section 4.2 Partial Exercise
Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be
exercised in whole or in part at any time prior to the time when the Option or portion thereof
becomes unexercisable under Section 3.3; provided, however, that each partial
exercise shall be for not less than one hundred (100) shares of Common Stock (or the minimum
installment set forth in Section 3.1, if a smaller number of shares of Common Stock) and shall be
for whole shares only.
5
Section 4.3 Manner of Exercise
The Option, or any exercisable portion thereof, may be exercised solely by delivery to the
Stock Option Administrator or an agent of the Stock Option Administrator, as designated by the
Committee from time to time, of all of the following prior to the time when the Option or such
portion becomes unexercisable under Section 3.3:
(a) A written notice complying with the applicable rules established by the Committee stating
that the Option, or a portion thereof, is exercised. The notice shall be signed by the Optionee or
other person then entitled to exercise the Option or such portion; and
(b) (i) payment in cash or in cash equivalents equal to the product of the per share
exercise price times the number of shares of Common Stock with respect to which the option
or portion is being exercised (the Aggregate Exercise Price);
(ii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, through the tender to Catalyst of shares of Common Stock,
which shares shall be valued, for purposes of determining the extent to which the Exercise
Price has been paid thereby, at their Fair Market Value on the date of exercise;
(iii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by delivering a written direction to Catalyst that the Option
be exercised pursuant to a cashless exercise/sale procedure (pursuant to which funds to
pay for exercise of the Option are delivered to Catalyst by a broker upon receipt of stock
certificates from Catalyst) or a cashless exercise/loan procedure (pursuant to which the
participants would obtain a margin loan from a broker to fund the exercise) through a
licensed broker acceptable to Catalyst whereby the stock certificate or certificates for the
shares of Common Stock for which the Option is exercised will be delivered to such broker as
the agent for the individual exercising the Option and the broker will deliver to Catalyst
cash (or cash equivalents acceptable to Catalyst) equal to the purchase price for the shares
of Common Stock purchased pursuant to the exercise of the Option plus the amount (if any) of
federal and other taxes that Catalyst may, in its judgment, be required to withhold with
respect to the exercise of the Option;
(iv) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by the delivery of a promissory note of the participant to
Catalyst on such terms as the Committee shall specify in its sole and absolute discretion;
or
(v) by a combination of the methods described in clauses (i), (ii), (iii) and (iv).
(c) A bona fide written representation and agreement, in a form satisfactory to the Committee,
signed by the Optionee or other person then entitled to exercise such Option or portion, stating
that the shares of Common Stock are being acquired for his own account, for
6
investment and without any present intention of distributing or reselling said shares or any
of them except as may be permitted under the Securities Act and then applicable rules and
regulations thereunder, and that the Optionee or other person then entitled to exercise such Option
or portion will indemnify Catalyst against and hold it free and harmless from any loss, damage,
expense or liability resulting to Catalyst if any sale or distribution of the shares of Common
Stock by such person is contrary to the representation and agreement referred to above. The
Committee may, in its absolute discretion, take whatever additional actions it deems appropriate to
insure the observance and performance of such representation and agreement and to effect compliance
with the Securities Act and any other federal or state securities laws or regulations. Without
limiting the generality of the foregoing, the Committee may require an opinion of counsel
acceptable to it to the effect that any subsequent transfer of shares of Common Stock acquired on
an Option exercise does not violate the Securities Act, and may issue stop-transfer orders covering
such shares. Share certificates evidencing stock issued on exercise of this Option shall bear an
appropriate legend referring to the provisions of this subsection (c) and the agreements herein.
The written representation and agreement referred to in the first sentence of this subsection (c)
shall, however, not be required if the shares of Common Stock to be issued pursuant to such
exercise have been registered under the Securities Act, and such registration is then effective in
respect of such shares; and
(d) Full payment to Catalyst (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option; and
(e) In the event the Option or any portion thereof shall be exercised pursuant to Section 4.1
by any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
Section 4.4 Conditions to Issuance of Stock Certificates
The shares of Common Stock deliverable upon the exercise of the Option, or any portion
thereof, may be either previously authorized but unissued shares or issued shares which have then
been reacquired by Catalyst. Such shares of Common Stock shall be fully paid and nonassessable.
Catalyst shall not be required to issue or deliver any certificate or certificates for shares of
stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of
the following conditions:
(a) The admission of such shares of Common Stock to listing on all stock exchanges on which
such class of stock is then listed; and
(b) The completion of any registration or other qualification of such shares of Common Stock
under any state or federal law or under rulings or regulations of the Securities and Exchange
Commission or of any other governmental regulatory body, which the Committee shall, in its absolute
discretion, deem necessary or advisable; and
7
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by Catalyst of full payment for such shares of Common Stock, including payment
of all amounts which, under federal, state or local tax law, Catalyst (or other employer
corporation) is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
Section 4.5 Rights as Shareholder
The holder of the Option shall not be, nor have any of the rights or privileges of, a
shareholder of Catalyst in respect of any shares of Common Stock purchasable upon the exercise of
any part of the Option unless and until certificates representing such shares of Common Stock shall
have been issued by Catalyst to such holder.
ARTICLE V
EFFECT OF CHANGES IN CAPITALIZATION
Section 5.1 Recapitalization
If the outstanding shares of Common Stock of Catalyst are increased or decreased or changed
into or exchanged for a different number or kind of shares or other securities of Catalyst by
reason of any recapitalization, reclassification, reorganization (other than as described in
Section 5.2 below), stock split, reverse split, combination of shares, exchange of shares, stock
dividend or other distribution payable in capital stock of Catalyst, or other increase or decrease
in such shares effected without receipt of consideration by Catalyst, an appropriate and
proportionate adjustment shall be made by the Committee in the number and kind of shares of Common
Stock issuable upon exercise of this Option, and in the purchase price per share of this Option.
Section 5.2 Reorganization or Change in Control
In the event of a Reorganization (as defined below) of Catalyst or a Change in Control (as
defined below) of Catalyst, this Option shall become immediately vested and, to the extent
applicable, exercisable for such period of time specified in Section 3.3(a). For purposes of this
Agreement a Reorganization of an entity shall be deemed to occur if such entity is a party to a
merger, consolidation, reorganization, or other business combination with one or more entities in
which said entity is not the surviving entity, if such entity disposes of substantially all of its
assets, or if such entity is a party to a spin-off, split-off, split-up or similar transaction;
provided, however, that the transaction shall not be a Reorganization if Catalyst, any parent or
any subsidiary is the surviving entity. For purposes of this Agreement, a Change in Control
8
shall be deemed to occur if any person or group of persons shall acquire direct or indirect
beneficial ownership (whether as a result of stock ownership, revocable or irrevocable proxies or
otherwise) of securities of an entity, pursuant to one or more transactions, such that after
consummation and as a result of such transaction, such person has direct or indirect beneficial
ownership of 50% or more of the total combined voting power of the Common Stock. For purposes of
this Agreement, a person shall mean any person, corporation, partnership, joint venture or other
entity or any group (as such term is defined for purposes of Section 13(d) of the Securities
Exchange Act of 1934, as amended (the Exchange Act)), other than a parent or subsidiary, and
beneficial ownership shall be determined in accordance with Rule 13d-3 under the Exchange Act.
Section 5.3 Dissolution or Liquidation
Upon the dissolution or liquidation of Catalyst, this Option shall terminate. In the event of
any termination of this Option under this Section 5.3, Optionee shall have the right, immediately
prior to the occurrence of such termination and during such reasonable period as the Committee in
its sole discretion shall determine and designate, to exercise this Option in whole or in part,
whether or not this Option was otherwise exercisable at the time such termination occurs and
without regard to any vesting or other limitation on exercise imposed pursuant to Article III
above.
Section 5.4 Adjustments
Adjustments under this Article V related to stock or securities of Catalyst shall be made by
the Committee, whose determination in that respect shall be final, binding, and conclusive. No
fractional shares of Common Stock or units of other securities shall be issued pursuant to any such
adjustment, and any fractions resulting from any such adjustment shall be eliminated in each case
by rounding downward to the nearest whole share or unit.
Section 5.5 No Limitations
The grant of this Option hereunder shall not affect or limit in any way the right or power of
Catalyst to make adjustments, reclassifications, reorganizations or changes of its capital or
business structure or to merge, consolidate, dissolve or liquidate, or to sell or transfer all or
any part of its business or assets.
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ARTICLE VI
OTHER PROVISIONS
Section 6.1 Administration
All actions taken and all interpretations and determinations made by the Committee in good
faith shall be final and binding upon the Optionee, Catalyst and all other interested persons. No
member of the Committee shall be personally liable for any action, determination or interpretation
made in good faith with respect to the Option. In its absolute discretion, the Board may at any
time and from time to time exercise any and all rights and duties of the Committee under the Plan
and this Agreement except with respect to matters which under Rule 16b-3 or Section 162(m) of the
Code, or any regulations or rules issued thereunder, are required to be determined in the sole
discretion of the Committee.
Section 6.2 Option Not Transferable
This Option shall not be assignable or transferable by the Optionee, other than by will or the
laws of descent and distribution; provided, however, that this Option may be transferred or
assigned to (i) family members or entities (including trusts) established for the benefit of the
Optionee or the Optionees family members or (ii) any other person, as permitted by applicable
securities law. Any Option assigned or transferred pursuant to this Section 6.2 shall continue to
be subject to the same terms and conditions as were applicable to the Option immediately before the
transfer; provided, however, that any Option transferred for value may not be exercised under any
Registration Statement on Form S-8 and upon exercise of such transferred Option the holder will
only be entitled to receive shares of restricted stock that have not been registered under the
Securities Act of 1933.
Section 6.3 Shares to Be Reserved
Catalyst shall at all times during the term of the Option reserve and keep available such
number of shares of Common Stock as will be sufficient to satisfy the requirements of this
Agreement.
Section 6.4 Notices
Any notice to be given under the terms of this Agreement to Catalyst shall be addressed to
Catalyst in care of the officer designated as the Stock Option Administrator from time to time, and
any notice to be given to the Optionee shall be addressed to him at the address given beneath his
signature hereto. By a notice given pursuant to this Section 6.4, either party may hereafter
designate a different address for notices to be given to him. Any notice which is required to be
given to the Optionee shall, if the Optionee is then deceased, be given to the Optionees personal
representative if such representative has previously informed Catalyst of his status and address by
written notice under this Section 6.4. Any notice shall be deemed duly given when enclosed in a
properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a
post office or branch post office regularly maintained by the United
10
States Postal Service; provided, however, that any notice to be given by the
Optionee relating to the exercise of the Option or any portion thereof shall be deemed duly given
upon receipt by the Stock Option Administrator or his office.
Section 6.5 Titles
Titles are provided herein for convenience only and are not to serve as a basis for
interpretation or construction of this Agreement.
Section 6.6 Construction
This Agreement shall be administered, interpreted and enforced under the internal laws of the
State of Florida without regard to conflicts of laws thereof.
Section 6.7 Conformity to Securities Laws
The Optionee acknowledges that this Agreement is intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and
rules promulgated by the Securities and Exchange Commission thereunder, including, without
limitation, the applicable exemptive conditions of Rule 16b-3. Notwithstanding anything herein to
the contrary, the Option is granted and may be exercised, only in such a manner as to conform to
such laws, rules and regulations. To the extent permitted by applicable law, this Agreement shall
be deemed amended to the extent necessary to conform to such laws, rules and regulations.
Section 6.8 Amendments
This Agreement may be amended without the consent of the Optionee provided that such amendment
would not impair any rights of the Optionee under this Agreement. No amendment of this Agreement
shall, without the consent of the Optionee, impair any rights of the Optionee under this Agreement.
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IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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By: |
/s/
Patrick J. McEnany |
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Name: |
Patrick J. McEnany |
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Title: |
CEO |
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/s/
Hubert Huckel |
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Optionee |
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NON-QUALIFIED STOCK OPTION AGREEMENT
THIS AGREEMENT, entered into on March 4, 2005 (the Grant Date), is made by and between
Catalyst Pharmaceutical Partners, Inc., a Florida corporation (Catalyst) and Hubert E. Huckel,
M.D., an employee of Catalyst, hereinafter referred to as Optionee:
WHEREAS, Catalyst is desirous of increasing the incentive of the Optionee whose contributions
are important to the continued success of Catalyst.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and
valuable consideration, receipt of which is hereby acknowledged, Catalyst hereby grants the
Optionee the Non-qualified Stock Option provided for herein, upon the following terms and
conditions:
ARTICLE I
DEFINITIONS
Whenever the following terms are used in this Agreement, they shall have the meaning specified
below unless the context clearly indicates to the contrary. The masculine pronoun shall include
the feminine and neuter, and the singular the plural, where the context so indicates.
Section 1.1 Board
Board shall mean the Board of Directors of Catalyst.
Section 1.2 Cause
Cause shall mean (i) failure or refusal of the Optionee to perform the duties and
responsibilities that Catalyst requires to be performed by him, (ii) gross negligence or willful
misconduct by the Optionee in the performance of his duties, (iii) commission by the Optionee of an
act of dishonesty affecting Catalyst, or the commission of an act constituting common law fraud or
a felony, or (iv) the Optionees commission of an act (other than the good faith exercise of his
business judgment in the exercise of his responsibilities) resulting in material damages to
Catalyst; provided, however, that if the Optionee and Catalyst have entered into an employment
agreement which defines cause for purposes of such agreement, cause shall be defined in
accordance with such agreement. The Committee, in its sole and absolute discretion, shall
determine whether a termination of employment is for Cause.
Section 1.3 Common Stock
Common Stock shall mean the common stock of Catalyst, par value $.01 per share.
Section 1.4 Code
Code shall mean the Internal Revenue Code of 1986, as amended.
Section 1.5 Committee
Committee shall mean the Compensation Committee of the Board, or another committee of the
Board, to administer the grant of Options.
Section 1.6 Director
Director shall mean a member of the Board.
Section 1.7 Exchange Act
Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
Section 1.8 Fair Market Value
Fair Market Value of a share of Common Stock as of a given date shall be (a) the closing
price of a share of Common Stock on the principal exchange on which shares of Common Stock are then
trading, if any (or as reported on any composite index which includes such principal exchange), on
the trading day previous to such date, or if shares of Common Stock were not traded on the trading
day previous to such date, then on the next preceding date on which a trade occurred; (b) if Common
Stock is not traded on an exchange but is quoted on The Nasdaq National Market, The Nasdaq SmallCap
Market or a successor quotation system, the last sales price for the Common Stock on the trading
day previous to such date as reported by The Nasdaq National Market, The Nasdaq SmallCap Market or
such successor quotation system; or (c) if Common Stock is not publicly traded on an exchange and
not quoted on The Nasdaq National Market, The Nasdaq SmallCap Market or a successor quotation
system, the fair market value of a share of Common Stock as established by the Committee acting in
good faith.
Section 1.9 Grant Date
Grant Date shall mean March 4, 2005
Section 1.10 Option
Option shall mean the non-qualified stock option to purchase Common Stock of Catalyst
granted under this Agreement.
Section 1.11 Rule 16b-3
Rule 16b-3 shall mean that certain Rule 16b-3 under the Exchange Act, as such Rule may be
amended from time to time.
2
Section 1.12 Securities Act
Securities Act shall mean the Securities Act of 1933, as amended.
Section 1.13 Stock Option Administrator
Stock Option Administrator shall mean the officer designated, from time to time, by the
Committee to serve as the Stock Option Administrator and any agents of the Stock Option
Administrator.
Section 1.14 Termination of Employment
Termination of Employment shall mean the time when the employee-employer relationship
between the Optionee and Catalyst is terminated for any reason, with or without Cause, including,
but not by way of limitation, a termination by resignation, discharge, death, disability or
retirement; but excluding (i) terminations where there is a simultaneous reemployment or continuing
employment of the Optionee by Catalyst, (ii) at the discretion of the Committee, terminations which
result in a temporary severance of the employee-employer relationship, and (iii) at the discretion
of the Committee, terminations which are followed by the simultaneous establishment of a consulting
relationship by Catalyst with the former employee. The Committee, in its absolute discretion,
shall determine the effect of all matters and questions relating to Termination of Employment,
including, but not by way of limitation, the question of whether a Termination of Employment
resulted from a discharge for Cause, and all questions of whether a particular leave of absence
constitutes a Termination of Employment. Notwithstanding any other provision of this Agreement,
Catalyst has an absolute and unrestricted right to terminate the Optionees employment at any time
for any reason whatsoever, with or without Cause, except to the extent expressly provided otherwise
in writing.
ARTICLE II
GRANT OF OPTION
Section 2.1 Grant of Option
For good and valuable consideration, on the date hereof Catalyst irrevocably grants to the
Optionee the option to purchase any part or all of an aggregate of 250,000 shares of its Common
Stock upon the terms and conditions set forth in this Agreement.
Section 2.2 Purchase Price
The purchase price of the shares of Common Stock covered by the Option shall be $1.00 per
share without commission or other charge.
Section 2.3 Consideration to Catalyst
In consideration of the granting of this Option by Catalyst, the Optionee agrees to render
faithful and efficient services to Catalyst, with such duties and responsibilities as Catalyst
3
shall from time to time prescribe. Nothing in this Agreement shall confer upon the Optionee any
right to continue in the employ of Catalyst, or as a director of Catalyst, or shall interfere with
or restrict in any way the rights of Catalyst, which are hereby expressly reserved, to discharge
the Optionee at any time for any reason whatsoever, with or without Cause.
ARTICLE III
PERIOD OF EXERCISABILITY
Section 3.1 Commencement of Exercisability
(a) Subject to subsection (b) and Sections 3.3 and 3.4, the Option shall become exercisable in
cumulative installments as follows:
(i) The first installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the six month anniversary of the Grant
Date.
(ii) The second installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the eighteen month anniversary of the
Grant Date.
(iii) The third installment shall consist of one-third of the shares of Common Stock
covered by the Option and shall become exercisable on the twenty-four month anniversary of
the Grant Date.
(b) Except as provided in Section 3.4(b) below, no portion of the Option which is
unexercisable at Termination of Employment shall thereafter become exercisable.
Section 3.2 Duration of Exercisability
The installments provided for in Section 3.1 are cumulative. Each such installment which
becomes exercisable pursuant to Section 3.1 shall remain exercisable until it becomes unexercisable
under Section 3.3.
Section 3.3 Expiration of Option
The Option may not be exercised to any extent by anyone after the first to occur of the
following events:
(a) The expiration of ten (10) years from the date the Option was granted; or
(b) The expiration of ninety (90) days from the date of the Optionees Termination of
Employment, unless such Termination of Employment results from his death, his disability (within
the meaning of Section 22(e)(3) of the Code) or his being discharged for Cause; or
4
(c) The date specified in Section 3.3(a) above in the event that the Optionees Termination of
Employment results from his death; or
(d) The expiration of one (1) year from the date of the Optionees Termination of Employment
in the event such Termination of Employment results from his disability (within the meaning of
Section 22(e)(3) of the Code); or
(e) The date of Optionees Termination of Employment, as applicable, in the event that the
Termination of Employment results from his being discharged for Cause.
Section 3.4 Acceleration of Exercisability
In the event of the Optionees Termination of Employment due to the Optionees death,
notwithstanding any vesting schedule provided for hereunder, this Option shall become immediately
vested and, to the extent applicable, exercisable for such period of time specified in Section
3.3(a).
ARTICLE IV
EXERCISE OF OPTION
Section 4.1 Persons Eligible to Exercise
During the lifetime of the Optionee, only the Optionee, or any person to whom the Option may
be transferred pursuant to Section 6.2 below, may exercise the Option or any portion thereof.
After the death of the Optionee, any exercisable portion of the Option may, prior to the time when
the Option becomes unexercisable under Section 3.3, be exercised by his personal representative or
by any person empowered to do so under the deceased Optionees will or under the then applicable
laws of descent and distribution.
Section 4.2 Partial Exercise
Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be
exercised in whole or in part at any time prior to the time when the Option or portion thereof
becomes unexercisable under Section 3.3; provided, however, that each partial
exercise shall be for not less than one hundred (100) shares of Common Stock (or the minimum
installment set forth in Section 3.1, if a smaller number of shares of Common Stock) and shall be
for whole shares only.
Section 4.3 Manner of Exercise
The Option, or any exercisable portion thereof, may be exercised solely by delivery to the
Stock Option Administrator or an agent of the Stock Option Administrator, as designated by the
Committee from time to time, of all of the following prior to the time when the Option or such
portion becomes unexercisable under Section 3.3:
5
(a) A written notice complying with the applicable rules established by the Committee stating
that the Option, or a portion thereof, is exercised. The notice shall be signed by the Optionee or
other person then entitled to exercise the Option or such portion; and
(b) (i) payment in cash or in cash equivalents equal to the product of the per share
exercise price times the number of shares of Common Stock with respect to which the option
or portion is being exercised (the Aggregate Exercise Price);
(ii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, through the tender to Catalyst of shares of Common Stock,
which shares shall be valued, for purposes of determining the extent to which the Exercise
Price has been paid thereby, at their Fair Market Value on the date of exercise;
(iii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by delivering a written direction to Catalyst that the Option
be exercised pursuant to a cashless exercise/sale procedure (pursuant to which funds to
pay for exercise of the Option are delivered to Catalyst by a broker upon receipt of stock
certificates from Catalyst) or a cashless exercise/loan procedure (pursuant to which the
participants would obtain a margin loan from a broker to fund the exercise) through a
licensed broker acceptable to Catalyst whereby the stock certificate or certificates for the
shares of Common Stock for which the Option is exercised will be delivered to such broker as
the agent for the individual exercising the Option and the broker will deliver to Catalyst
cash (or cash equivalents acceptable to Catalyst) equal to the purchase price for the shares
of Common Stock purchased pursuant to the exercise of the Option plus the amount (if any) of
federal and other taxes that Catalyst may, in its judgment, be required to withhold with
respect to the exercise of the Option;
(iv) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by the delivery of a promissory note of the participant to
Catalyst on such terms as the Committee shall specify in its sole and absolute discretion;
or
(v) by a combination of the methods described in clauses (i), (ii), (iii) and (iv).
(c) A bona fide written representation and agreement, in a form satisfactory to the Committee,
signed by the Optionee or other person then entitled to exercise such Option or portion,
stating that the shares of Common Stock are being acquired for his own account, for investment
and without any present intention of distributing or reselling said shares or any of them except as
may be permitted under the Securities Act and then applicable rules and regulations thereunder, and
that the Optionee or other person then entitled to exercise such Option or portion will indemnify
Catalyst against and hold it free and harmless from any loss, damage, expense or liability
resulting to Catalyst if any sale or distribution of the shares of Common Stock by such person is
contrary to the representation and agreement referred to above. The Committee may, in its absolute
discretion, take whatever additional actions it deems appropriate to insure the observance and
performance of such representation and agreement and
6
to effect compliance with the Securities Act
and any other federal or state securities laws or regulations. Without limiting the generality of
the foregoing, the Committee may require an opinion of counsel acceptable to it to the effect that
any subsequent transfer of shares of Common Stock acquired on an Option exercise does not violate
the Securities Act, and may issue stop-transfer orders covering such shares. Share certificates
evidencing stock issued on exercise of this Option shall bear an appropriate legend referring to
the provisions of this subsection (c) and the agreements herein. The written representation and
agreement referred to in the first sentence of this subsection (c) shall, however, not be required
if the shares of Common Stock to be issued pursuant to such exercise have been registered under the
Securities Act, and such registration is then effective in respect of such shares; and
(d) Full payment to Catalyst (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option; and
(e) In the event the Option or any portion thereof shall be exercised pursuant to Section 4.1
by any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
Section 4.4 Conditions to Issuance of Stock Certificates
The shares of Common Stock deliverable upon the exercise of the Option, or any portion
thereof, may be either previously authorized but unissued shares or issued shares which have then
been reacquired by Catalyst. Such shares of Common Stock shall be fully paid and nonassessable.
Catalyst shall not be required to issue or deliver any certificate or certificates for shares of
stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of
the following conditions:
(a) The admission of such shares of Common Stock to listing on all stock exchanges on which
such class of stock is then listed; and
(b) The completion of any registration or other qualification of such shares of Common Stock
under any state or federal law or under rulings or regulations of the Securities and Exchange
Commission or of any other governmental regulatory body, which the Committee shall, in its absolute
discretion, deem necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by Catalyst of full payment for such shares of Common Stock, including payment
of all amounts which, under federal, state or local tax law, Catalyst (or other employer
corporation) is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
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Section 4.5 Rights as Shareholder
The holder of the Option shall not be, nor have any of the rights or privileges of, a
shareholder of Catalyst in respect of any shares of Common Stock purchasable upon the exercise of
any part of the Option unless and until certificates representing such shares of Common Stock shall
have been issued by Catalyst to such holder.
ARTICLE V
EFFECT OF CHANGES IN CAPITALIZATION
Section 5.1 Recapitalization
If the outstanding shares of Common Stock of Catalyst are increased or decreased or changed
into or exchanged for a different number or kind of shares or other securities of Catalyst by
reason of any recapitalization, reclassification, reorganization (other than as described in
Section 5.2 below), stock split, reverse split, combination of shares, exchange of shares, stock
dividend or other distribution payable in capital stock of Catalyst, or other increase or decrease
in such shares effected without receipt of consideration by Catalyst, an appropriate and
proportionate adjustment shall be made by the Committee in the number and kind of shares of Common
Stock issuable upon exercise of this Option, and in the purchase price per share of this Option.
Section 5.2 Reorganization or Change in Control
In the event of a Reorganization (as defined below) of Catalyst or a Change in Control (as
defined below) of Catalyst, this Option shall become immediately vested and, to the extent
applicable, exercisable for such period of time specified in Section 3.3(a). For purposes of this
Agreement a Reorganization of an entity shall be deemed to occur if such entity is a party to a
merger, consolidation, reorganization, or other business combination with one or more entities in
which said entity is not the surviving entity, if such entity disposes of substantially all of its
assets, or if such entity is a party to a spin-off, split-off, split-up or similar transaction;
provided, however, that the transaction shall not be a Reorganization if Catalyst, any parent or
any subsidiary is the surviving entity. For purposes of this Agreement, a Change in Control
shall be deemed to occur if any person or group of
persons shall acquire direct or indirect beneficial ownership (whether as a result of stock
ownership, revocable or irrevocable proxies or otherwise) of securities of an entity, pursuant to
one or more transactions, such that after consummation and as a result of such transaction, such
person has direct or indirect beneficial ownership of 50% or more of the total combined voting
power of the Common Stock. For purposes of this Agreement, a person shall mean any person,
corporation, partnership, joint venture or other entity or any group (as such term is defined for
purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (the Exchange Act)),
other than a parent or subsidiary, and beneficial ownership shall be determined in accordance
with Rule 13d-3 under the Exchange Act.
Section 5.3 Dissolution or Liquidation
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Upon the dissolution or liquidation of Catalyst, this Option shall terminate. In the event of
any termination of this Option under this Section 5.3, Optionee shall have the right, immediately
prior to the occurrence of such termination and during such reasonable period as the Committee in
its sole discretion shall determine and designate, to exercise this Option in whole or in part,
whether or not this Option was otherwise exercisable at the time such termination occurs and
without regard to any vesting or other limitation on exercise imposed pursuant to Article III
above.
Section 5.4 Adjustments
Adjustments under this Article V related to stock or securities of Catalyst shall be made by
the Committee, whose determination in that respect shall be final, binding, and conclusive. No
fractional shares of Common Stock or units of other securities shall be issued pursuant to any such
adjustment, and any fractions resulting from any such adjustment shall be eliminated in each case
by rounding downward to the nearest whole share or unit.
Section 5.5 No Limitations
The grant of this Option hereunder shall not affect or limit in any way the right or power of
Catalyst to make adjustments, reclassifications, reorganizations or changes of its capital or
business structure or to merge, consolidate, dissolve or liquidate, or to sell or transfer all or
any part of its business or assets.
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ARTICLE VI
OTHER PROVISIONS
Section 6.1 Administration
All actions taken and all interpretations and determinations made by the Committee in good
faith shall be final and binding upon the Optionee, Catalyst and all other interested persons. No
member of the Committee shall be personally liable for any action, determination or interpretation
made in good faith with respect to the Option. In its absolute discretion, the Board may at any
time and from time to time exercise any and all rights and duties of the Committee under the Plan
and this Agreement except with respect to matters which under Rule 16b-3 or Section 162(m) of the
Code, or any regulations or rules issued thereunder, are required to be determined in the sole
discretion of the Committee.
Section 6.2 Option Not Transferable
This Option shall not be assignable or transferable by the Optionee, other than by will or the
laws of descent and distribution; provided, however, that this Option may be transferred or
assigned to (i) family members or entities (including trusts) established for the benefit of the
Optionee or the Optionees family members or (ii) any other person, as permitted by applicable
securities law. Any Option assigned or transferred pursuant to this Section 6.2 shall continue to
be subject to the same terms and conditions as were applicable to the Option immediately before the
transfer; provided, however, that any Option transferred for value may not be exercised under any
Registration Statement on Form S-8 and upon exercise of such transferred Option the holder will
only be entitled to receive shares of restricted stock that have not been registered under the
Securities Act of 1933.
Section 6.3 Shares to Be Reserved
Catalyst shall at all times during the term of the Option reserve and keep available such
number of shares of Common Stock as will be sufficient to satisfy the requirements of this
Agreement.
Section 6.4 Notices
Any notice to be given under the terms of this Agreement to Catalyst shall be addressed to
Catalyst in care of the officer designated as the Stock Option Administrator from time to time, and
any notice to be given to the Optionee shall be addressed to him at the address given beneath his
signature hereto. By a notice given pursuant to this Section 6.4, either party may hereafter
designate a different address for notices to be given to him. Any notice which is required to be
given to the Optionee shall, if the Optionee is then deceased, be given to the Optionees personal
representative if such representative has previously informed Catalyst of his status and address by
written notice under this Section 6.4. Any notice shall be deemed duly given when enclosed in a
properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a
post office or branch post office regularly maintained by the United
10
States Postal Service;
provided, however, that any notice to be
given by the Optionee relating to the exercise of the Option or any portion thereof shall be
deemed duly given upon receipt by the Stock Option Administrator or his office.
Section 6.5 Titles
Titles are provided herein for convenience only and are not to serve as a basis for
interpretation or construction of this Agreement.
Section 6.6 Construction
This Agreement shall be administered, interpreted and enforced under the internal laws of the
State of Florida without regard to conflicts of laws thereof.
Section 6.7 Conformity to Securities Laws
The Optionee acknowledges that this Agreement is intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and
rules promulgated by the Securities and Exchange Commission thereunder, including, without
limitation, the applicable exemptive conditions of Rule 16b-3. Notwithstanding anything herein to
the contrary, the Option is granted and may be exercised, only in such a manner as to conform to
such laws, rules and regulations. To the extent permitted by applicable law, this Agreement shall
be deemed amended to the extent necessary to conform to such laws, rules and regulations.
Section 6.8 Amendments
This Agreement may be amended without the consent of the Optionee provided that such amendment
would not impair any rights of the Optionee under this Agreement. No amendment of this Agreement
shall, without the consent of the Optionee, impair any rights of the Optionee under this Agreement.
11
IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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/s/ Patrick J. McEnany
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Name: |
Patrick J. McEnany |
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Title: |
President and CEO |
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/s/ Hubert Huckel
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Optionee |
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EXHIBIT 10.6 STOCK OPTION AGREEMENTS/JACK WEINSTEI
Exhibit 10.6
NON-QUALIFIED STOCK OPTION AGREEMENT
THIS AGREEMENT, entered into on October 1st, 2004 (the Grant Date), is made by and between
Catalyst Pharmaceutical Partners, Inc., a Florida corporation (Catalyst) and Jack Weinstein, a
Consultant to Catalyst, hereinafter referred to as Optionee:
WHEREAS, Catalyst is desirous of increasing the incentive of the Optionee whose contributions
are important to the continued success of Catalyst.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and
valuable consideration, receipt of which is hereby acknowledged, Catalyst hereby grants the
Optionee the Non-qualified Stock Option provided for herein, upon the following terms and
conditions:
ARTICLE I
DEFINITIONS
Whenever the following terms are used in this Agreement, they shall have the meaning specified
below unless the context clearly indicates to the contrary. The masculine pronoun shall include
the feminine and neuter, and the singular the plural, where the context so indicates.
Section 1.1 Board
Board shall mean the Board of Directors of Catalyst.
Section 1.2 Cause
Cause shall mean (i) failure or refusal of the Optionee to perform the duties and
responsibilities that Catalyst requires to be performed by him, (ii) gross negligence or willful
misconduct by the Optionee in the performance of his duties, (iii) commission by the Optionee of an
act of dishonesty affecting Catalyst, or the commission of an act constituting common law fraud or
a felony, or (iv) the Optionees commission of an act (other than the good faith exercise of his
business judgment in the exercise of his responsibilities) resulting in material damages to
Catalyst; provided, however, that if the Optionee and Catalyst have entered into an employment
agreement which defines cause for purposes of such agreement, cause shall be defined in
accordance with such agreement. The Committee, in its sole and absolute discretion, shall
determine whether a termination of employment is for Cause.
Section 1.3 Common Stock
Common Stock shall mean the common stock of Catalyst, par value $.01 per share.
Section 1.4 Code
Code shall mean the Internal Revenue Code of 1986, as amended.
Section 1.5 Committee
Committee shall mean the Compensation Committee of the Board, or another committee of the
Board, to administer the grant of Options.
Section 1.6 Director
Director shall mean a member of the Board.
Section 1.7 Exchange Act
Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
Section 1.8 Fair Market Value
Fair Market Value of a share of Common Stock as of a given date shall be (a) the closing
price of a share of Common Stock on the principal exchange on which shares of Common Stock are then
trading, if any (or as reported on any composite index which includes such principal exchange), on
the trading day previous to such date, or if shares of Common Stock were not traded on the trading
day previous to such date, then on the next preceding date on which a trade occurred; (b) if Common
Stock is not traded on an exchange but is quoted on The Nasdaq National Market, The Nasdaq SmallCap
Market or a successor quotation system, the last sales price for the Common Stock on the trading
day previous to such date as reported by The Nasdaq National Market, The Nasdaq SmallCap Market or
such successor quotation system; or (c) if Common Stock is not publicly traded on an exchange and
not quoted on The Nasdaq National Market, The Nasdaq SmallCap Market or a successor quotation
system, the fair market value of a share of Common Stock as established by the Committee acting in
good faith.
Section 1.9 Grant Date
Grant Date shall mean October 1, 2004.
Section 1.10 Option
Option shall mean the non-qualified stock option to purchase Common Stock of Catalyst
granted under this Agreement.
Section 1.11 Rule 16b-3
Rule 16b-3 shall mean that certain Rule 16b-3 under the Exchange Act, as such Rule may be
amended from time to time.
2
Section 1.12 Securities Act
Securities Act shall mean the Securities Act of 1933, as amended.
Section 1.13 Stock Option Administrator
Stock Option Administrator shall mean the officer designated, from time to time, by the
Committee to serve as the Stock Option Administrator and any agents of the Stock Option
Administrator.
Section 1.14 Termination of Employment
Termination of Employment shall mean the time when the employee-employer relationship or the
consulting relationship between the Optionee and Catalyst is terminated for any reason, with or
without Cause, including, but not by way of limitation, a termination by resignation, discharge,
death, disability or retirement; but excluding (i) terminations where there is a simultaneous
reemployment or continuing employment of the Optionee by Catalyst, (ii) at the discretion of the
Committee, terminations which result in a temporary severance of the employee-employer
relationship, and (iii) at the discretion of the Committee, terminations which are followed by the
simultaneous establishment of a consulting relationship by Catalyst with the former employee. The
Committee, in its absolute discretion, shall determine the effect of all matters and questions
relating to Termination of Employment, including, but not by way of limitation, the question of
whether a Termination of Employment resulted from a discharge for Cause, and all questions of
whether a particular leave of absence constitutes a Termination of Employment. Notwithstanding any
other provision of this Agreement, Catalyst has an absolute and unrestricted right to terminate the
Optionees employment at any time for any reason whatsoever, with or without Cause, except to the
extent expressly provided otherwise in writing.
ARTICLE II
GRANT OF OPTION
Section 2.1 Grant of Option
In consideration of the Optionees agreement to remain in the employ of Catalyst and for other
good and valuable consideration, on the date hereof Catalyst irrevocably grants to the Optionee the
option to purchase any part or all of an aggregate of 150,000 shares of its Common Stock upon the
terms and conditions set forth in this Agreement.
Section 2.2 Purchase Price
The purchase price of the shares of Common Stock covered by the Option shall be $2.00 per
share for the options referred to in Sections 3.1(a) and (b) below and $4.35 per share for the
options referred to in Section 3.1(c) below, in each case without commission or other charge.
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Section 2.3 Consideration to Catalyst
In consideration of the granting of this Option by Catalyst, the Optionee agrees to render
faithful and efficient services to Catalyst, with such duties and responsibilities as Catalyst
shall from time to time prescribe. Nothing in this Agreement shall confer upon the Optionee any
right to continue in the employ of Catalyst, or as a director of Catalyst, or shall interfere with
or restrict in any way the rights of Catalyst, which are hereby expressly reserved, to discharge
the Optionee at any time for any reason whatsoever, with or without Cause.
ARTICLE III
PERIOD OF EXERCISABILITY
Section 3.1 Commencement of Exercisability
The options granted hereunder shall vest on the following schedule:
(a) Options to purchase 50,000 shares shall vest on the Grant Date;
(b) Options to purchase 50,000 shares shall vest on the date that is one year after the Grant
Date, so long as the Optionee remains a consultant of the Company as of that date; and
(c) Options to purchase 50,000 shares shall vest upon the closing of an equity financing by
the Company during the term of that certain Consulting Agreement, dated effective as of October 1,
2004, between Optionee and Catalyst of at least $2.0 million.
Section 3.2 Expiration of Option
The Option may not be exercised to any extent by anyone after the first to occur of the
following events:
(a) The expiration of five (5) years from the date the Option was granted; or
(b) The expiration of ninety (90) days from the date of the Optionees Termination of
Employment, unless such Termination of Employment results from his death, his disability (within
the meaning of Section 22(e)(3) of the Code) or his being discharged for Cause; or
(c) The date specified in Section 3.2(a) above in the event that the Optionees Termination of
Employment results from his death; or
(d) The expiration of one (1) year from the date of the Optionees Termination of Employment
in the event such Termination of Employment results from his disability (within the meaning of
Section 22(e)(3) of the Code); or
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(e) The date of Optionees Termination of Employment, as applicable, in the event that the
Termination of Employment results from his being discharged for Cause.
Section 3.3 Acceleration of Exercisability
In the event of the Optionees Termination of Employment due to the Optionees death,
notwithstanding any vesting schedule provided for hereunder, this Option shall become immediately
vested and, to the extent applicable, exercisable for such period of time specified in Section
3.2(a).
ARTICLE IV
EXERCISE OF OPTION
Section 4.1 Persons Eligible to Exercise
During the lifetime of the Optionee, only the Optionee, or any person to whom the Option may
be transferred pursuant to Section 6.2 below, may exercise the Option or any portion thereof.
After the death of the Optionee, any exercisable portion of the Option may, prior to the time when
the Option becomes unexercisable under Section 3.2, be exercised by his personal representative or
by any person empowered to do so under the deceased Optionees will or under the then applicable
laws of descent and distribution.
Section 4.2 Partial Exercise
Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be
exercised in whole or in part at any time prior to the time when the Option or portion thereof
becomes unexercisable under Section 3.2; provided, however, that each partial
exercise shall be for not less than one hundred (100) shares of Common Stock (or the minimum
installment set forth in Section 3.1, if a smaller number of shares of Common Stock) and shall be
for whole shares only.
Section 4.3 Manner of Exercise
The Option, or any exercisable portion thereof, may be exercised solely by delivery to the
Stock Option Administrator or an agent of the Stock Option Administrator, as designated by the
Committee from time to time, of all of the following prior to the time when the Option or such
portion becomes unexercisable under Section 3.2:
(a) A written notice complying with the applicable rules established by the Committee stating
that the Option, or a portion thereof, is exercised. The notice shall be signed by the Optionee or
other person then entitled to exercise the Option or such portion; and
(b) (i) payment in cash or in cash equivalents equal to the product of the per share
exercise price times the number of shares of Common Stock with respect to which the option
or portion is being exercised (the Aggregate Exercise Price);
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(ii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, through the tender to Catalyst of shares of Common Stock,
which shares shall be valued, for purposes of determining the extent to which the Exercise
Price has been paid thereby, at their Fair Market Value on the date of exercise;
(iii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by delivering a written direction to Catalyst that the Option
be exercised pursuant to a cashless exercise/sale procedure (pursuant to which funds to
pay for exercise of the Option are delivered to Catalyst by a broker upon receipt of stock
certificates from Catalyst) or a cashless exercise/loan procedure (pursuant to which the
participants would obtain a margin loan from a broker to fund the exercise) through a
licensed broker acceptable to Catalyst whereby the stock certificate or certificates for the
shares of Common Stock for which the Option is exercised will be delivered to such broker as
the agent for the individual exercising the Option and the broker will deliver to Catalyst
cash (or cash equivalents acceptable to Catalyst) equal to the purchase price for the shares
of Common Stock purchased pursuant to the exercise of the Option plus the amount (if any) of
federal and other taxes that Catalyst may, in its judgment, be required to withhold with
respect to the exercise of the Option;
(iv) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by the delivery of a promissory note of the participant to
Catalyst on such terms as the Committee shall specify in its sole and absolute discretion;
or
(v) by a combination of the methods described in clauses (i), (ii), (iii) and (iv).
(c) A bona fide written representation and agreement, in a form satisfactory to the Committee,
signed by the Optionee or other person then entitled to exercise such Option or portion, stating
that the shares of Common Stock are being acquired for his own account, for investment and without
any present intention of distributing or reselling said shares or any of them except as may be
permitted under the Securities Act and then applicable rules and regulations thereunder, and that
the Optionee or other person then entitled to exercise such Option or portion will indemnify
Catalyst against and hold it free and harmless from any loss, damage, expense or liability
resulting to Catalyst if any sale or distribution of the shares of Common Stock by such person is
contrary to the representation and agreement referred to above. The Committee may, in its absolute
discretion, take whatever additional actions it deems appropriate to insure the observance and
performance of such representation and agreement and to effect compliance with the Securities Act
and any other federal or state securities laws or regulations. Without limiting the generality of
the foregoing, the Committee may require an opinion of counsel acceptable to it to the effect that
any subsequent transfer of shares of Common Stock acquired on an Option exercise does not violate
the Securities Act, and may issue stop-transfer orders covering such shares. Share certificates
evidencing stock issued on exercise of this Option shall bear an appropriate legend referring to
the provisions of this subsection (c) and the agreements herein. The written representation and
agreement referred to
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in the first sentence of this subsection (c)
shall, however, not be required if the shares of Common Stock to be issued pursuant to such
exercise have been registered under the Securities Act, and such registration is then effective in
respect of such shares; and
(d) Full payment to Catalyst (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option; and
(e) In the event the Option or any portion thereof shall be exercised pursuant to Section 4.1
by any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
Section 4.4 Conditions to Issuance of Stock Certificates
The shares of Common Stock deliverable upon the exercise of the Option, or any portion
thereof, may be either previously authorized but unissued shares or issued shares which have then
been reacquired by Catalyst. Such shares of Common Stock shall be fully paid and nonassessable.
Catalyst shall not be required to issue or deliver any certificate or certificates for shares of
stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of
the following conditions:
(a) The admission of such shares of Common Stock to listing on all stock exchanges on which
such class of stock is then listed; and
(b) The completion of any registration or other qualification of such shares of Common Stock
under any state or federal law or under rulings or regulations of the Securities and Exchange
Commission or of any other governmental regulatory body, which the Committee shall, in its absolute
discretion, deem necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by Catalyst of full payment for such shares of Common Stock, including payment
of all amounts which, under federal, state or local tax law, Catalyst (or other employer
corporation) is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
Section 4.5 Rights as Shareholder
The holder of the Option shall not be, nor have any of the rights or privileges of, a
shareholder of Catalyst in respect of any shares of Common Stock purchasable upon the exercise of
any part of the Option unless and until certificates representing such shares of Common Stock shall
have been issued by Catalyst to such holder.
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ARTICLE V
EFFECT OF CHANGES IN CAPITALIZATION
Section 5.1 Recapitalization
If the outstanding shares of Common Stock of Catalyst are increased or decreased or changed
into or exchanged for a different number or kind of shares or other securities of Catalyst by
reason of any recapitalization, reclassification, reorganization (other than as described in
Section 5.2 below), stock split, reverse split, combination of shares, exchange of shares, stock
dividend or other distribution payable in capital stock of Catalyst, or other increase or decrease
in such shares effected without receipt of consideration by Catalyst, an appropriate and
proportionate adjustment shall be made by the Committee in the number and kind of shares of Common
Stock issuable upon exercise of this Option, and in the purchase price per share of this Option.
Section 5.2 Reorganization or Change in Control
In the event of a Reorganization (as defined below) of Catalyst or a Change in Control (as
defined below) of Catalyst, this Option shall become immediately vested and, to the extent
applicable, exercisable for such period of time specified in Section 3.2(a). For purposes of this
Agreement a Reorganization of an entity shall be deemed to occur if such entity is a party to a
merger, consolidation, reorganization, or other business combination with one or more entities in
which said entity is not the surviving entity, if such entity disposes of substantially all of its
assets, or if such entity is a party to a spin-off, split-off, split-up or similar transaction;
provided, however, that the transaction shall not be a Reorganization if Catalyst, any parent or
any subsidiary is the surviving entity. For purposes of this Agreement, a Change in Control
shall be deemed to occur if any person or group of persons shall acquire direct or indirect
beneficial ownership (whether as a result of stock ownership, revocable or irrevocable proxies or
otherwise) of securities of an entity, pursuant to one or more transactions, such that after
consummation and as a result of such transaction, such person has direct or indirect beneficial
ownership of 50% or more of the total combined voting power of the Common Stock. For purposes of
this Agreement, a person shall mean any person, corporation, partnership, joint venture or other
entity or any group (as such term is defined for purposes of Section 13(d) of the Securities
Exchange Act of 1934, as amended (the Exchange Act)), other than a parent or subsidiary, and
beneficial ownership shall be determined in accordance with Rule 13d-3 under the Exchange Act.
Section 5.3 Dissolution or Liquidation
Upon the dissolution or liquidation of Catalyst, this Option shall terminate. In the event of
any termination of this Option under this Section 5.3, Optionee shall have the right, immediately
prior to the occurrence of such termination and during such reasonable period as the Committee in
its sole discretion shall determine and designate, to exercise this Option in whole or in part,
whether or not this Option was otherwise exercisable at the time such termination occurs
and without regard to any vesting or other limitation on exercise imposed pursuant to Article
III above.
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Section 5.4 Adjustments
Adjustments under this Article V related to stock or securities of Catalyst shall be made by
the Committee, whose determination in that respect shall be final, binding, and conclusive. No
fractional shares of Common Stock or units of other securities shall be issued pursuant to any such
adjustment, and any fractions resulting from any such adjustment shall be eliminated in each case
by rounding downward to the nearest whole share or unit.
Section 5.5 No Limitations
The grant of this Option hereunder shall not affect or limit in any way the right or power of
Catalyst to make adjustments, reclassifications, reorganizations or changes of its capital or
business structure or to merge, consolidate, dissolve or liquidate, or to sell or transfer all or
any part of its business or assets.
ARTICLE VI
OTHER PROVISIONS
Section 6.1 Administration
All actions taken and all interpretations and determinations made by the Committee in good
faith shall be final and binding upon the Optionee, Catalyst and all other interested persons. No
member of the Committee shall be personally liable for any action, determination or interpretation
made in good faith with respect to the Option. In its absolute discretion, the Board may at any
time and from time to time exercise any and all rights and duties of the Committee under the Plan
and this Agreement except with respect to matters which under Rule 16b-3 or Section 162(m) of the
Code, or any regulations or rules issued thereunder, are required to be determined in the sole
discretion of the Committee.
Section 6.2 Option Not Transferable
This Option shall not be assignable or transferable by the Optionee, other than by will or the
laws of descent and distribution; provided, however, that this Option may be transferred or
assigned to (i) family members or entities (including trusts) established for the benefit of the
Optionee or the Optionees family members or (ii) any other person, as permitted by applicable
securities law. Any Option assigned or transferred pursuant to this Section 6.2 shall continue to
be subject to the same terms and conditions as were applicable to the Option immediately before the
transfer; provided, however, that any Option transferred for value may not be exercised under any
Registration Statement on Form S-8 and upon exercise of such transferred Option the holder will
only be entitled to receive shares of restricted stock that have not been registered under the
Securities Act of 1933.
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Section 6.3 Shares to Be Reserved
Catalyst shall at all times during the term of the Option reserve and keep available such
number of shares of Common Stock as will be sufficient to satisfy the requirements of this
Agreement.
Section 6.4 Notices
Any notice to be given under the terms of this Agreement to Catalyst shall be addressed to
Catalyst in care of the officer designated as the Stock Option Administrator from time to time, and
any notice to be given to the Optionee shall be addressed to him at the address given beneath his
signature hereto. By a notice given pursuant to this Section 6.4, either party may hereafter
designate a different address for notices to be given to him. Any notice which is required to be
given to the Optionee shall, if the Optionee is then deceased, be given to the Optionees personal
representative if such representative has previously informed Catalyst of his status and address by
written notice under this Section 6.4. Any notice shall be deemed duly given when enclosed in a
properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a
post office or branch post office regularly maintained by the United States Postal Service;
provided, however, that any notice to be given by the Optionee relating to the
exercise of the Option or any portion thereof shall be deemed duly given upon receipt by the Stock
Option Administrator or his office.
Section 6.5 Titles
Titles are provided herein for convenience only and are not to serve as a basis for
interpretation or construction of this Agreement.
Section 6.6 Construction
This Agreement shall be administered, interpreted and enforced under the internal laws of the
State of Florida without regard to conflicts of laws thereof.
Section 6.7 Conformity to Securities Laws
The Optionee acknowledges that this Agreement is intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and
rules promulgated by the Securities and Exchange Commission thereunder, including, without
limitation, the applicable exemptive conditions of Rule 16b-3. Notwithstanding anything herein to
the contrary, the Option is granted and may be exercised, only in such a manner as to conform to
such laws, rules and regulations. To the extent permitted by applicable law, this Agreement shall
be deemed amended to the extent necessary to conform to such laws, rules and regulations.
Section 6.8 Amendments
This Agreement may be amended without the consent of the Optionee provided that such amendment
would not impair any rights of the Optionee under this Agreement. No
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amendment of this Agreement shall, without the consent of the Optionee, impair any rights of
the Optionee under this Agreement.
IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto.
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CATALYST PHARMACEUTICAL PARTNERS, INC. |
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Patrick J. McEnany |
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/s/ Jack Weinstein
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Optionee |
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NON-QUALIFIED STOCK OPTION AGREEMENT
THIS AGREEMENT, entered into on March 4, 2005 (the Grant Date), is made by and between
Catalyst Pharmaceutical Partners, Inc., a Florida corporation (Catalyst) and Jack Weinstein, a
Consultant to Catalyst, hereinafter referred to as Optionee:
WHEREAS, Catalyst is desirous of increasing the incentive of the Optionee whose contributions
are important to the continued success of Catalyst.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and
valuable consideration, receipt of which is hereby acknowledged, Catalyst hereby grants the
Optionee the Non-qualified Stock Option provided for herein, upon the following terms and
conditions:
ARTICLE I
DEFINITIONS
Whenever the following terms are used in this Agreement, they shall have the meaning specified
below unless the context clearly indicates to the contrary. The masculine pronoun shall include
the feminine and neuter, and the singular the plural, where the context so indicates.
Section 1.1 Board
Board shall mean the Board of Directors of Catalyst.
Section 1.2 Cause
Cause shall mean (i) failure or refusal of the Optionee to perform the duties and
responsibilities that Catalyst requires to be performed by him, (ii) gross negligence or willful
misconduct by the Optionee in the performance of his duties, (iii) commission by the Optionee of an
act of dishonesty affecting Catalyst, or the commission of an act constituting common law fraud or
a felony, or (iv) the Optionees commission of an act (other than the good faith exercise of his
business judgment in the exercise of his responsibilities) resulting in material damages to
Catalyst; provided, however, that if the Optionee and Catalyst have entered into an employment
agreement which defines cause for purposes of such agreement, cause shall be defined in
accordance with such agreement. The Committee, in its sole and absolute discretion, shall
determine whether a termination of employment is for Cause.
Section 1.3 Common Stock
Common Stock shall mean the common stock of Catalyst, par value $.01 per share.
Section 1.4 Code
Code shall mean the Internal Revenue Code of 1986, as amended.
Section 1.5 Committee
Committee shall mean the Compensation Committee of the Board, or another committee of the
Board, to administer the grant of Options.
Section 1.6 Director
Director shall mean a member of the Board.
Section 1.7 Exchange Act
Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
Section 1.8 Fair Market Value
Fair Market Value of a share of Common Stock as of a given date shall be (a) the closing
price of a share of Common Stock on the principal exchange on which shares of Common Stock are then
trading, if any (or as reported on any composite index which includes such principal exchange), on
the trading day previous to such date, or if shares of Common Stock were not traded on the trading
day previous to such date, then on the next preceding date on which a trade occurred; (b) if Common
Stock is not traded on an exchange but is quoted on The Nasdaq National Market, The Nasdaq SmallCap
Market or a successor quotation system, the last sales price for the Common Stock on the trading
day previous to such date as reported by The Nasdaq National Market, The Nasdaq SmallCap Market or
such successor quotation system; or (c) if Common Stock is not publicly traded on an exchange and
not quoted on The Nasdaq National Market, The Nasdaq SmallCap Market or a successor quotation
system, the fair market value of a share of Common Stock as established by the Committee acting in
good faith.
Section 1.9 Grant Date
Grant Date shall mean March 4, 2005.
Section 1.10 Option
Option shall mean the non-qualified stock option to purchase Common Stock of Catalyst
granted under this Agreement.
Section 1.11 Rule 16b-3
Rule 16b-3 shall mean that certain Rule 16b-3 under the Exchange Act, as such Rule may be
amended from time to time.
2
Section 1.12 Securities Act
Securities Act shall mean the Securities Act of 1933, as amended.
Section 1.13 Stock Option Administrator
Stock Option Administrator shall mean the officer designated, from time to time, by the
Committee to serve as the Stock Option Administrator and any agents of the Stock Option
Administrator.
Section 1.14 Termination of Employment
Termination of Employment shall mean the time when the employee-employer relationship or the
consulting relationship between the Optionee and Catalyst is terminated for any reason, with or
without Cause, including, but not by way of limitation, a termination by resignation, discharge,
death, disability or retirement; but excluding (i) terminations where there is a simultaneous
reemployment or continuing employment of the Optionee by Catalyst, (ii) at the discretion of the
Committee, terminations which result in a temporary severance of the employee-employer
relationship, and (iii) at the discretion of the Committee, terminations which are followed by the
simultaneous establishment of a consulting relationship by Catalyst with the former employee. The
Committee, in its absolute discretion, shall determine the effect of all matters and questions
relating to Termination of Employment, including, but not by way of limitation, the question of
whether a Termination of Employment resulted from a discharge for Cause, and all questions of
whether a particular leave of absence constitutes a Termination of Employment. Notwithstanding any
other provision of this Agreement, Catalyst has an absolute and unrestricted right to terminate the
Optionees employment at any time for any reason whatsoever, with or without Cause, except to the
extent expressly provided otherwise in writing.
ARTICLE II
GRANT OF OPTION
Section 2.1 Grant of Option
In consideration of the Optionees agreement to remain in the employ of Catalyst and for other
good and valuable consideration, on the date hereof Catalyst irrevocably grants to the Optionee the
option to purchase any part or all of an aggregate of 150,000 shares of its Common Stock upon the
terms and conditions set forth in this Agreement.
Section 2.2 Purchase Price
The purchase price of the shares of Common Stock covered by the Option shall be $2.00 per
share for the options referred to in Sections 3.1(a) and (b) below and $4.35 per share for the
options referred to in Section 3.1(c) below, in each case without commission or other charge.
3
Section 2.3 Consideration to Catalyst
In consideration of the granting of this Option by Catalyst, the Optionee agrees to render
faithful and efficient services to Catalyst, with such duties and responsibilities as Catalyst
shall from time to time prescribe. Nothing in this Agreement shall confer upon the Optionee any
right to continue in the employ of Catalyst, or as a director of Catalyst, or shall interfere with
or restrict in any way the rights of Catalyst, which are hereby expressly reserved, to discharge
the Optionee at any time for any reason whatsoever, with or without Cause.
ARTICLE III
PERIOD OF EXERCISABILITY
Section 3.1 Commencement of Exercisability
The options granted hereunder shall vest on the following schedule:
(a) Options to purchase 50,000 shares shall vest on the Grant Date;
(b) Options to purchase 50,000 shares shall vest on October 1, 2005, so long as the Optionee
remains a consultant of the Company as of that date; and
(c) Options to purchase 50,000 shares shall vest upon the closing of an equity financing by
the Company during the term of that certain Consulting Agreement, dated effective as of October 1,
2004, between Optionee and Catalyst of at least $2.0 million.
Section 3.2 Expiration of Option
The Option may not be exercised to any extent by anyone after the first to occur of the
following events:
(a) The expiration of five (5) years from the date the Option was granted; or
(b) The expiration of ninety (90) days from the date of the Optionees Termination of
Employment, unless such Termination of Employment results from his death, his disability (within
the meaning of Section 22(e)(3) of the Code) or his being discharged for Cause; or
(c) The date specified in Section 3.2(a) above in the event that the Optionees Termination of
Employment results from his death; or
(d) The expiration of one (1) year from the date of the Optionees Termination of Employment
in the event such Termination of Employment results from his disability (within the meaning of
Section 22(e)(3) of the Code); or
(e) The date of Optionees Termination of Employment, as applicable, in the event that the
Termination of Employment results from his being discharged for Cause.
4
Section 3.3 Acceleration of Exercisability
In the event of the Optionees Termination of Employment due to the Optionees death,
notwithstanding any vesting schedule provided for hereunder, this Option shall become immediately
vested and, to the extent applicable, exercisable for such period of time specified in Section
3.2(a).
ARTICLE IV
EXERCISE OF OPTION
Section 4.1 Persons Eligible to Exercise
During the lifetime of the Optionee, only the Optionee, or any person to whom the Option may
be transferred pursuant to Section 6.2 below, may exercise the Option or any portion thereof.
After the death of the Optionee, any exercisable portion of the Option may, prior to the time when
the Option becomes unexercisable under Section 3.2, be exercised by his personal representative or
by any person empowered to do so under the deceased Optionees will or under the then applicable
laws of descent and distribution.
Section 4.2 Partial Exercise
Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be
exercised in whole or in part at any time prior to the time when the Option or portion thereof
becomes unexercisable under Section 3.2; provided, however, that each partial
exercise shall be for not less than one hundred (100) shares of Common Stock (or the minimum
installment set forth in Section 3.1, if a smaller number of shares of Common Stock) and shall be
for whole shares only.
Section 4.3 Manner of Exercise
The Option, or any exercisable portion thereof, may be exercised solely by delivery to the
Stock Option Administrator or an agent of the Stock Option Administrator, as designated by the
Committee from time to time, of all of the following prior to the time when the Option or such
portion becomes unexercisable under Section 3.2:
(a) A written notice complying with the applicable rules established by the Committee stating
that the Option, or a portion thereof, is exercised. The notice shall be signed by the Optionee or
other person then entitled to exercise the Option or such portion; and
(b) (i) payment in cash or in cash equivalents equal to the product of the per share
exercise price times the number of shares of Common Stock with respect to which the option
or portion is being exercised (the Aggregate Exercise Price);
(ii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, through the tender to Catalyst of shares of
Common Stock, which shares shall be valued, for purposes of determining the extent to
5
which the Exercise Price has been paid thereby, at their Fair Market Value on the date of
exercise;
(iii) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by delivering a written direction to Catalyst that the Option
be exercised pursuant to a cashless exercise/sale procedure (pursuant to which funds to
pay for exercise of the Option are delivered to Catalyst by a broker upon receipt of stock
certificates from Catalyst) or a cashless exercise/loan procedure (pursuant to which the
participants would obtain a margin loan from a broker to fund the exercise) through a
licensed broker acceptable to Catalyst whereby the stock certificate or certificates for the
shares of Common Stock for which the Option is exercised will be delivered to such broker as
the agent for the individual exercising the Option and the broker will deliver to Catalyst
cash (or cash equivalents acceptable to Catalyst) equal to the purchase price for the shares
of Common Stock purchased pursuant to the exercise of the Option plus the amount (if any) of
federal and other taxes that Catalyst may, in its judgment, be required to withhold with
respect to the exercise of the Option;
(iv) to the extent permitted by applicable law and agreed to by the Committee in its
sole and absolute discretion, by the delivery of a promissory note of the participant to
Catalyst on such terms as the Committee shall specify in its sole and absolute discretion;
or
(v) by a combination of the methods described in clauses (i), (ii), (iii) and (iv).
(c) A bona fide written representation and agreement, in a form satisfactory to the Committee,
signed by the Optionee or other person then entitled to exercise such Option or portion, stating
that the shares of Common Stock are being acquired for his own account, for investment and without
any present intention of distributing or reselling said shares or any of them except as may be
permitted under the Securities Act and then applicable rules and regulations thereunder, and that
the Optionee or other person then entitled to exercise such Option or portion will indemnify
Catalyst against and hold it free and harmless from any loss, damage, expense or liability
resulting to Catalyst if any sale or distribution of the shares of Common Stock by such person is
contrary to the representation and agreement referred to above. The Committee may, in its absolute
discretion, take whatever additional actions it deems appropriate to insure the observance and
performance of such representation and agreement and to effect compliance with the Securities Act
and any other federal or state securities laws or regulations. Without limiting the generality of
the foregoing, the Committee may require an opinion of counsel acceptable to it to the effect that
any subsequent transfer of shares of Common Stock acquired on an Option exercise does not violate
the Securities Act, and may issue stop-transfer orders covering such shares. Share certificates
evidencing stock issued on exercise of this Option shall bear an appropriate legend referring to
the provisions of this subsection (c) and the agreements herein. The written representation and
agreement referred to in the first sentence of this subsection (c) shall, however, not be required
if the shares of Common Stock to be issued pursuant to such
exercise have been registered under the Securities Act, and such registration is then
effective in respect of such shares; and
6
(d) Full payment to Catalyst (or other employer corporation) of all amounts which, under
federal, state or local tax law, it is required to withhold upon exercise of the Option; and
(e) In the event the Option or any portion thereof shall be exercised pursuant to Section 4.1
by any person or persons other than the Optionee, appropriate proof of the right of such person or
persons to exercise the Option.
Section 4.4 Conditions to Issuance of Stock Certificates
The shares of Common Stock deliverable upon the exercise of the Option, or any portion
thereof, may be either previously authorized but unissued shares or issued shares which have then
been reacquired by Catalyst. Such shares of Common Stock shall be fully paid and nonassessable.
Catalyst shall not be required to issue or deliver any certificate or certificates for shares of
stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of
the following conditions:
(a) The admission of such shares of Common Stock to listing on all stock exchanges on which
such class of stock is then listed; and
(b) The completion of any registration or other qualification of such shares of Common Stock
under any state or federal law or under rulings or regulations of the Securities and Exchange
Commission or of any other governmental regulatory body, which the Committee shall, in its absolute
discretion, deem necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by Catalyst of full payment for such shares of Common Stock, including payment
of all amounts which, under federal, state or local tax law, Catalyst (or other employer
corporation) is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
Section 4.5 Rights as Shareholder
The holder of the Option shall not be, nor have any of the rights or privileges of, a
shareholder of Catalyst in respect of any shares of Common Stock purchasable upon the exercise of
any part of the Option unless and until certificates representing such shares of Common Stock shall
have been issued by Catalyst to such holder.
ARTICLE V
EFFECT OF CHANGES IN CAPITALIZATION
7
Section 5.1 Recapitalization
If the outstanding shares of Common Stock of Catalyst are increased or decreased or changed
into or exchanged for a different number or kind of shares or other securities of Catalyst by
reason of any recapitalization, reclassification, reorganization (other than as described in
Section 5.2 below), stock split, reverse split, combination of shares, exchange of shares, stock
dividend or other distribution payable in capital stock of Catalyst, or other increase or decrease
in such shares effected without receipt of consideration by Catalyst, an appropriate and
proportionate adjustment shall be made by the Committee in the number and kind of shares of Common
Stock issuable upon exercise of this Option, and in the purchase price per share of this Option.
Section 5.2 Reorganization or Change in Control
In the event of a Reorganization (as defined below) of Catalyst or a Change in Control (as
defined below) of Catalyst, this Option shall become immediately vested and, to the extent
applicable, exercisable for such period of time specified in Section 3.2(a). For purposes of this
Agreement a Reorganization of an entity shall be deemed to occur if such entity is a party to a
merger, consolidation, reorganization, or other business combination with one or more entities in
which said entity is not the surviving entity, if such entity disposes of substantially all of its
assets, or if such entity is a party to a spin-off, split-off, split-up or similar transaction;
provided, however, that the transaction shall not be a Reorganization if Catalyst, any parent or
any subsidiary is the surviving entity. For purposes of this Agreement, a Change in Control
shall be deemed to occur if any person or group of persons shall acquire direct or indirect
beneficial ownership (whether as a result of stock ownership, revocable or irrevocable proxies or
otherwise) of securities of an entity, pursuant to one or more transactions, such that after
consummation and as a result of such transaction, such person has direct or indirect beneficial
ownership of 50% or more of the total combined voting power of the Common Stock. For purposes of
this Agreement, a person shall mean any person, corporation, partnership, joint venture or other
entity or any group (as such term is defined for purposes of Section 13(d) of the Securities
Exchange Act of 1934, as amended (the Exchange Act)), other than a parent or subsidiary, and
beneficial ownership shall be determined in accordance with Rule 13d-3 under the Exchange Act.
Section 5.3 Dissolution or Liquidation
Upon the dissolution or liquidation of Catalyst, this Option shall terminate. In the event of
any termination of this Option under this Section 5.3, Optionee shall have the right, immediately
prior to the occurrence of such termination and during such reasonable period as the Committee in
its sole discretion shall determine and designate, to exercise this Option in whole or in part,
whether or not this Option was otherwise exercisable at the time such termination occurs
and without regard to any vesting or other limitation on exercise imposed pursuant to Article
III above.
Section 5.4 Adjustments
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Adjustments under this Article V related to stock or securities of Catalyst shall be made by
the Committee, whose determination in that respect shall be final, binding, and conclusive. No
fractional shares of Common Stock or units of other securities shall be issued pursuant to any such
adjustment, and any fractions resulting from any such adjustment shall be eliminated in each case
by rounding downward to the nearest whole share or unit.
Section 5.5 No Limitations
The grant of this Option hereunder shall not affect or limit in any way the right or power of
Catalyst to make adjustments, reclassifications, reorganizations or changes of its capital or
business structure or to merge, consolidate, dissolve or liquidate, or to sell or transfer all or
any part of its business or assets.
ARTICLE VI
OTHER PROVISIONS
Section 6.1 Administration
All actions taken and all interpretations and determinations made by the Committee in good
faith shall be final and binding upon the Optionee, Catalyst and all other interested persons. No
member of the Committee shall be personally liable for any action, determination or interpretation
made in good faith with respect to the Option. In its absolute discretion, the Board may at any
time and from time to time exercise any and all rights and duties of the Committee under the Plan
and this Agreement except with respect to matters which under Rule 16b-3 or Section 162(m) of the
Code, or any regulations or rules issued thereunder, are required to be determined in the sole
discretion of the Committee.
Section 6.2 Option Not Transferable
This Option shall not be assignable or transferable by the Optionee, other than by will or the
laws of descent and distribution; provided, however, that this Option may be transferred or
assigned to (i) family members or entities (including trusts) established for the benefit of the
Optionee or the Optionees family members or (ii) any other person, as permitted by applicable
securities law. Any Option assigned or transferred pursuant to this Section 6.2 shall continue to
be subject to the same terms and conditions as were applicable to the Option immediately before the
transfer; provided, however, that any Option transferred for value may not be exercised under any
Registration Statement on Form S-8 and upon exercise of such transferred Option the holder will
only be entitled to receive shares of restricted stock that have not been registered under the
Securities Act of 1933.
Section 6.3 Shares to Be Reserved
Catalyst shall at all times during the term of the Option reserve and keep available such
number of shares of Common Stock as will be sufficient to satisfy the requirements of this
Agreement.
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Section 6.4 Notices
Any notice to be given under the terms of this Agreement to Catalyst shall be addressed to
Catalyst in care of the officer designated as the Stock Option Administrator from time to time, and
any notice to be given to the Optionee shall be addressed to him at the address given beneath his
signature hereto. By a notice given pursuant to this Section 6.4, either party may hereafter
designate a different address for notices to be given to him. Any notice which is required to be
given to the Optionee shall, if the Optionee is then deceased, be given to the Optionees personal
representative if such representative has previously informed Catalyst of his status and address by
written notice under this Section 6.4. Any notice shall be deemed duly given when enclosed in a
properly sealed envelope or wrapper addressed as aforesaid, deposited (with postage prepaid) in a
post office or branch post office regularly maintained by the United States Postal Service;
provided, however, that any notice to be given by the Optionee relating to the
exercise of the Option or any portion thereof shall be deemed duly given upon receipt by the Stock
Option Administrator or his office.
Section 6.5 Titles
Titles are provided herein for convenience only and are not to serve as a basis for
interpretation or construction of this Agreement.
Section 6.6 Construction
This Agreement shall be administered, interpreted and enforced under the internal laws of the
State of Florida without regard to conflicts of laws thereof.
Section 6.7 Conformity to Securities Laws
The Optionee acknowledges that this Agreement is intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and
rules promulgated by the Securities and Exchange Commission thereunder, including, without
limitation, the applicable exemptive conditions of Rule 16b-3. Notwithstanding anything herein to
the contrary, the Option is granted and may be exercised, only in such a manner as to conform to
such laws, rules and regulations. To the extent permitted by applicable law, this Agreement shall
be deemed amended to the extent necessary to conform to such laws, rules and regulations.
Section 6.8 Amendments
This Agreement may be amended without the consent of the Optionee provided that such amendment
would not impair any rights of the Optionee under this Agreement. No
amendment of this Agreement shall, without the consent of the Optionee, impair any rights of
the Optionee under this Agreement.
IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto.
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CATALYST PHARMACEUTICAL PARTNERS, INC. |
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By: |
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/s/ Patrick J. McEnany |
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Name: |
Patrick J. McEnany |
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Title: |
C.E.O. |
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/s/ Jack Weinstein
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Optionee |
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11
EXHIBIT 10.7 STOCK OPTION AGREEMENTS/CHARLES O'KEE
Exhibit
10.7
NON-QUALIFIED STOCK OPTION AGREEMENT
THIS
AGREEMENT, entered into on January 3, 2005 (the Grant
Date), is made by and between Catalyst Pharmaceutical Partners, Inc., a Florida corporation
(Catalyst) and Charles OKeeffe, a consultant to Catalyst, hereinafter referred to as Optionee:
WHEREAS, Catalyst is desirous of increasing the incentive of the Optionee whose contributions
are important to the continued success of Catalyst.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and
valuable consideration, receipt of which is hereby acknowledged, Catalyst hereby grants the
Optionee the Non-qualified Stock Option provided for herein, upon the following terms and
conditions:
ARTICLE I
DEFINITIONS
Whenever the following terms are used in this Agreement, they shall have the meaning specified
below unless the context clearly indicates to the contrary. The masculine pronoun shall include
the feminine and neuter, and the singular the plural, where the context so indicates.
Section 1.1 Board
Board shall mean the Board of Directors of Catalyst.
Section 1.2 Common Stock
Common Stock shall mean the common stock of Catalyst, par value $.01 per share.
Section 1.3 Code
Code shall mean the Internal Revenue Code of 1986, as amended.
Section 1.4 Committee
Committee shall mean the Compensation Committee of the Board, or another committee of the
Board, or the full Board, if no Committee has been named, to administer the grant of Options.
Section 1.5 Director
Director shall mean a member of the Board.
Section 1.6 Exchange Act
Exchange Act shall mean the Securities Exchange Act of 1934, as amended.
Section 1.7 Grant Date
Grant Date shall mean January ___, 2005.
Section 1.8 Option
Option shall mean the non-qualified stock option to purchase Common Stock of Catalyst
granted under this Agreement.
Section 1.9 Rule 16b-3
Rule 16b-3 shall mean that certain Rule 16b-3 under the Exchange Act, as such Rule may be
amended from time to time.
Section 1.10 Securities Act
Securities Act shall mean the Securities Act of 1933, as amended.
Section 1.11 Stock Option Administrator
Stock Option Administrator shall mean the officer designated, from time to time, by the
Committee to serve as the Stock Option Administrator and any agents of the Stock Option
Administrator.
ARTICLE II
GRANT OF OPTION
Section 2.1 Grant of Option
In consideration of the Optionees agreement to serve as a Director and act as a consultant to
Catalyst, and for other good and valuable consideration, on the date hereof Catalyst irrevocably
grants to the Optionee the option to purchase any part or all of an aggregate of 50,000 shares of
its Common Stock upon the terms and conditions set forth in this Agreement.
Section 2.2 Purchase Price
The purchase price of the shares of Common Stock covered by the Option shall be $2.00 per
share without commission or other charge.
Section 2.3 Consideration to Catalyst
In consideration of the granting of this Option by Catalyst, the Optionee agrees to render
faithful and efficient services to Catalyst, with such duties and responsibilities as Catalyst
2
shall from time to time prescribe. Nothing in this Agreement shall confer upon the Optionee any
right to continue as a director or Consultant of Catalyst, or shall interfere with or restrict in
any way the rights of Catalyst, which are hereby expressly reserved, to discharge the Optionee at
any time for any reason whatsoever, with or without cause.
ARTICLE III
PERIOD OF EXERCISABILITY
Section 3.1 Commencement of Exercisability
The Option shall become exercisable immediately.
Section 3.2 Duration of Exercisability
The Option shall remain exercisable until they become unexercisable under Section 3.3.
Section 3.3 Expiration of Option
The Option may not be exercised to any extent by anyone after the expiration of the earlier
of: (a) five (5) years from the date the Option was granted; or (ii) one year from the date of
Optionees death.
ARTICLE IV
EXERCISE OF OPTION
Section 4.1 Persons Eligible to Exercise
During the lifetime of the Optionee, only the Optionee, or any person to whom the Option may
be transferred pursuant to Section 6.2 below, may exercise the Option or any portion thereof.
After the death of the Optionee, any exercisable portion of the Option may, prior to the time when
the Option becomes unexercisable under Section 3.3, be exercised by his personal representative or
by any person empowered to do so under the deceased Optionees will or under the then applicable
laws of descent and distribution.
Section 4.2 Partial Exercise
Any exercisable portion of the Option or the entire Option, if then wholly exercisable, may be
exercised in whole or in part at any time prior to the time when the Option or portion thereof
becomes unexercisable under Section 3.3; provided, however, that each partial
exercise shall be for not less than one hundred (100) shares of Common Stock and shall be for whole
shares only.
3
Section 4.3 Manner of Exercise
The Option, or any exercisable portion thereof, may be exercised solely by delivery to the
Stock Option Administrator or an agent of the Stock Option Administrator, as designated by the
Committee from time to time, of all of the following prior to the time when the Option or such
portion becomes unexercisable under Section 3.3:
(a) A written notice complying with the applicable rules established by the Committee
stating that the Option, or a portion thereof, is exercised. The notice shall be signed by
the Optionee or other person then entitled to exercise the Option or such portion. It shall
be accompanied by payment in cash equal to the product of the per share exercise price times
the number of shares of Common Stock with respect to which the option or portion is being
exercised;
(b) A bona fide written representation and agreement, in a form satisfactory to the
Committee, signed by the Optionee or other person then entitled to exercise such Option or
portion, stating that the shares of Common Stock are being acquired for his own account, for
investment and without any present intention of distributing or reselling said shares or any
of them except as may be permitted under the Securities Act and then applicable rules and
regulations thereunder, and that the Optionee or other person then entitled to exercise such
Option or portion will indemnify Catalyst against and hold it free and harmless from any
loss, damage, expense or liability resulting to Catalyst if any sale or distribution of the
shares of Common Stock by such person is contrary to the representation and agreement
referred to above. The Committee may, in its absolute discretion, take whatever additional
actions it deems appropriate to insure the observance and performance of such representation
and agreement and to effect compliance with the Securities Act and any other federal or
state securities laws or regulations. Without limiting the generality of the foregoing, the
Committee may require an opinion of counsel acceptable to it to the effect that any
subsequent transfer of shares of Common Stock acquired on an Option exercise does not
violate the Securities Act, and may issue stop-transfer orders covering such shares. Share
certificates evidencing stock issued on exercise of this Option shall bear an appropriate
legend referring to the provisions of this subsection (b) and the agreements herein. The
written representation and agreement referred to in the first sentence of this subsection
(c) shall, however, not be required if the shares of Common Stock to be issued pursuant to
such exercise have been registered under the Securities Act, and such registration is then
effective in respect of such shares; and
(c) Full payment to Catalyst of all amounts which, under federal, state or local tax
law, it is required to withhold upon exercise of the Option; and
(d) In the event the Option or any portion thereof shall be exercised pursuant to
Section 4.1 by any person or persons other than the Optionee, appropriate proof of the right
of such person or persons to exercise the Option.
4
Section 4.4 Conditions to Issuance of Stock Certificates
The shares of Common Stock deliverable upon the exercise of the Option, or any portion
thereof, may be either previously authorized but unissued shares or issued shares which have then
been reacquired by Catalyst. Such shares of Common Stock shall be fully paid and nonassessable.
Catalyst shall not be required to issue or deliver any certificate or certificates for shares of
stock purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of
the following conditions:
(a) The admission of such shares of Common Stock to listing on all stock exchanges on which
such class of stock is then listed; and
(b) The completion of any registration or other qualification of such shares of Common Stock
under any state or federal law or under rulings or regulations of the Securities and Exchange
Commission or of any other governmental regulatory body, which the Committee shall, in its absolute
discretion, deem necessary or advisable; and
(c) The obtaining of any approval or other clearance from any state or federal governmental
agency which the Committee shall, in its absolute discretion, determine to be necessary or
advisable; and
(d) The receipt by Catalyst of full payment for such shares of Common Stock, including payment
of all amounts which, under federal, state or local tax law, Catalyst (or other employer
corporation) is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the
Committee may from time to time establish for reasons of administrative convenience.
Section 4.5 Rights as Shareholder
The holder of the Option shall not be, nor have any of the rights or privileges of, a
shareholder of Catalyst in respect of any shares of Common Stock purchasable upon the exercise of
any part of the Option unless and until certificates representing such shares of Common Stock shall
have been issued by Catalyst to such holder.
5
ARTICLE V
EFFECT OF CHANGES IN CAPITALIZATION
Section 5.1 Recapitalization
If the outstanding shares of Common Stock of Catalyst are increased or decreased or changed
into or exchanged for a different number or kind of shares or other securities of Catalyst by
reason of any recapitalization, reclassification, reorganization (other than as described in
Section 5.2 below), stock split, reverse split, combination of shares, exchange of shares, stock
dividend or other distribution payable in capital stock of Catalyst, or other increase or decrease
in such shares effected without receipt of consideration by Catalyst, an appropriate and
proportionate adjustment shall be made by the Committee in the number and kind of shares of Common
Stock issuable upon exercise of this Option, and in the purchase price per share of this Option.
Section 5.2 Reorganization or Change in Control
In the event of a Reorganization (as defined below) of Catalyst, this Option shall become
immediately vested and, to the extent applicable, exercisable for such period of time specified in
Section 3.3(a). For purposes of this Agreement a Reorganization of an entity shall be deemed to
occur if such entity is a party to a merger, consolidation, reorganization, or other business
combination with one or more entities in which said entity is not the surviving entity, if such
entity disposes of substantially all of its assets, or if such entity is a party to a spin-off,
split-off, split-up or similar transaction; provided, however, that the transaction shall not be a
Reorganization if Catalyst, any parent or any subsidiary is the surviving entity.
Section 5.3 Dissolution or Liquidation
Upon the dissolution or liquidation of Catalyst, this Option shall terminate. In the event of
any termination of this Option under this Section 5.3, Optionee shall have the right, immediately
prior to the occurrence of such termination and during such reasonable period as the Committee in
its sole discretion shall determine and designate, to exercise this Option in whole or in part,
whether or not this Option was otherwise exercisable at the time such termination occurs and
without regard to any limitation on exercise imposed pursuant to Article III above.
Section 5.4 Adjustments
Adjustments under this Article V related to stock or securities of Catalyst shall be made by
the Committee, whose determination in that respect shall be final, binding, and conclusive. No
fractional shares of Common Stock or units of other securities shall be issued pursuant to any such
adjustment, and any fractions resulting from any such adjustment shall be eliminated in each case
by rounding downward to the nearest whole share or unit.
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Section 5.5 No Limitations
The grant of this Option hereunder shall not affect or limit in any way the right or power of
Catalyst to make adjustments, reclassifications, reorganizations or changes of its capital or
business structure or to merge, consolidate, dissolve or liquidate, or to sell or transfer all or
any part of its business or assets.
ARTICLE VI
OTHER PROVISIONS
Section 6.1 Administration
All actions taken and all interpretations and determinations made by the Committee in good
faith shall be final and binding upon the Optionee, Catalyst and all other interested persons. No
member of the Committee shall be personally liable for any action, determination or interpretation
made in good faith with respect to the Option. In its absolute discretion, the Board may at any
time and from time to time exercise any and all rights and duties of the Committee under the Plan
and this Agreement except with respect to matters which under Rule 16b-3 or Section 162(m) of the
Code, or any regulations or rules issued thereunder, are required to be determined in the sole
discretion of the Committee.
Section 6.2 Option Not Transferable
This Option shall not be assignable or transferable by the Optionee, other than by will or the
laws of descent and distribution; provided, however, that this Option may be transferred or
assigned to (i) family members or entities (including trusts) established for the benefit of the
Optionee or the Optionees family members or (ii) any other person, as permitted by applicable
securities law. Any Option assigned or transferred pursuant to this Section 6.2 shall continue to
be subject to the same terms and conditions as were applicable to the Option immediately before the
transfer; provided, however, that any Option transferred for value may not be exercised under any
Registration Statement on Form S-8 and upon exercise of such transferred Option the holder will
only be entitled to receive shares of restricted stock that have not been registered under the
Securities Act.
Section 6.3 Shares to Be Reserved
Catalyst shall at all times during the term of the Option reserve and keep available such
number of shares of Common Stock as will be sufficient to satisfy the requirements of this
Agreement.
Section 6.4 Notices
Any notice to be given under the terms of this Agreement to Catalyst shall be addressed to
Catalyst in care of the officer designated as the Stock Option Administrator from time to time, and
any notice to be given to the Optionee shall be addressed to him at the address
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given beneath his signature hereto. By a notice given pursuant to this Section 6.4, either
party may hereafter designate a different address for notices to be given to him. Any notice which
is required to be given to the Optionee shall, if the Optionee is then deceased, be given to the
Optionees personal representative if such representative has previously informed Catalyst of his
status and address by written notice under this Section 6.4. Any notice shall be deemed duly given
when enclosed in a properly sealed envelope or wrapper addressed as aforesaid, deposited (with
postage prepaid) in a post office or branch post office regularly maintained by the United States
Postal Service; provided, however, that any notice to be given by the Optionee
relating to the exercise of the Option or any portion thereof shall be deemed duly given upon
receipt by the Stock Option Administrator or his office.
Section 6.5 Titles
Titles are provided herein for convenience only and are not to serve as a basis for
interpretation or construction of this Agreement.
Section 6.6 Construction
This Agreement shall be administered, interpreted and enforced under the internal laws of the
State of Florida without regard to conflicts of laws thereof.
Section 6.7 Conformity to Securities Laws
The Optionee acknowledges that this Agreement is intended to conform to the extent necessary
with all provisions of the Securities Act and the Exchange Act and any and all regulations and
rules promulgated by the Securities and Exchange Commission thereunder, including, without
limitation, the applicable exemptive conditions of Rule 16b-3. Notwithstanding anything herein to
the contrary, the Option is granted and may be exercised, only in such a manner as to conform to
such laws, rules and regulations. To the extent permitted by applicable law, this Agreement shall
be deemed amended to the extent necessary to conform to such laws, rules and regulations.
Section 6.8 Amendments
This Agreement may be amended without the consent of the Optionee provided that such amendment
would not impair any rights of the Optionee under this Agreement. No amendment of this Agreement
shall, without the consent of the Optionee, impair any rights of the Optionee under this Agreement.
[Signatures on Next Page]
8
SIGNATURE PAGE
IN WITNESS WHEREOF, this Agreement has been executed and delivered by the parties hereto.
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CATALYST PHARMACEUTICAL PARTNERS, INC.
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By: |
/s/ Patrick J. McEnany
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Name: |
Patrick J. McEnany |
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Title: |
CEO |
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OPTIONEE:
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/s/ Charles OKeeffe
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Charles OKeeffe |
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9
EXHIBIT 10.8 STOCK INCENTIVE PLAN
Exhibit 10.8
CATALYST PHARMACEUTICAL PARTNERS, INC.
2006 STOCK INCENTIVE PLAN
1. ESTABLISHMENT, EFFECTIVE DATE AND TERM
Catalyst Pharmaceutical Partners, Inc. (Company), a Florida corporation hereby establishes
the Catalyst Pharmaceutical Partners, Inc. 2006 Stock Incentive Plan (Plan). The Effective Date
of the Plan shall be the date that the Plan was approved by the shareholders of the Company in
accordance with the laws of the State of Florida or such later date as provided in the resolutions
adopting the Plan; provided, however, no Award may be granted unless and until the Plan has been
approved by the shareholders of the Company. Unless earlier terminated pursuant to Section 15(k)
hereof, the Plan shall terminate on the tenth anniversary of the Effective Date. Capitalized terms
used herein are defined in Appendix A attached hereto.
2. PURPOSE
The purpose of the Plan is to enable the Company to attract, retain, reward and motivate
Eligible Individuals by providing them with an opportunity to acquire or increase a proprietary
interest in the Company and to incentivize them to expend maximum effort for the growth and success
of the Company, so as to strengthen the mutuality of the interests between the Eligible Individuals
and the shareholders of the Company.
3. ELIGIBILITY
Awards may be granted under the Plan to any Eligible Individual, as determined by the
Committee from time to time, on the basis of their importance to the business of the Company
pursuant to the terms of the Plan.
4. ADMINISTRATION
(a) Committee. The Plan shall be administered by the Committee, which shall have the
full power and authority to take all actions, and to make all determinations not inconsistent with
the specific terms and provisions of the Plan deemed by the Committee to be necessary or
appropriate to the administration of the Plan, any Award granted or any Award Agreement entered
into hereunder. The Committee may correct any defect or supply any omission or reconcile any
inconsistency in the Plan or in any Award Agreement in the manner and to the extent it shall deem
expedient to carry the Plan into effect as it may determine in its sole discretion. The decisions
by the Committee shall be final, conclusive and binding with respect to the interpretation and
administration of the Plan, any Award or any Award Agreement entered into under the Plan.
(b) Delegation to Officers or Employees. The Committee may designate officers or
employees of the Company to assist the Committee in the administration of the Plan. The Committee
may delegate authority to officers or employees of the Company to grant Awards and execute Award
Agreements or other documents on behalf of the Committee in connection with the administration of
the Plan, subject to whatever limitations or restrictions the Committee may impose and in
accordance with applicable law.
(c) Designation of Advisors. The Committee may designate professional advisors to
assist the Committee in the administration of the Plan. The Committee may employ such legal
counsel, consultants, and agents as it may deem desirable for the administration of the Plan and
may rely upon any advice and any computation received from any such counsel, consultant, or agent.
The Company shall pay all expenses and costs incurred by the Committee for the engagement of any
such counsel, consultant, or agent.
(d) Participants Outside the U.S. In order to conform with the provisions of local
laws and regulations in foreign countries in which the Company may operate in the future, the
Committee shall have the sole discretion to (i) modify the terms and conditions of the Awards
granted under the Plan to Eligible Individuals located outside the United States; (ii) establish
subplans with such modifications as may be necessary or advisable under the circumstances present
by local laws and regulations; and (iii) take any action which it deems advisable to comply with or
otherwise reflect any necessary governmental regulatory procedures, or to obtain any exemptions or
approvals necessary with respect to the Plan or any subplan established hereunder.
(e) Liability and Indemnification. No Covered Individual shall be liable for any
action or determination made in good faith with respect to the Plan, any Award granted hereunder or
any Award Agreement entered into hereunder. The Company shall, to the maximum extent permitted by
applicable law and the Articles of Incorporation and Bylaws of the Company, indemnify and hold
harmless each Covered Individual against any cost or expense (including reasonable attorney fees
reasonably acceptable to the Company) or liability (including any amount paid in settlement of a
claim with the approval of the Company), and amounts advanced to such Covered Individual necessary
to pay the foregoing at the earliest time and to the fullest extent permitted, arising out of any
act or omission to act in connection with the Plan, any Award granted hereunder or any Award
Agreement entered into hereunder. Such indemnification shall be in addition to any rights of
indemnification such individuals may have under applicable law or under the Articles of
Incorporation or Bylaws of the Company. Notwithstanding anything else herein, this indemnification
will not apply to the actions or determinations made by a Covered Individual with regard to Awards
granted to such Covered Individual under the Plan or arising out of such Covered Individuals own
fraud or bad faith.
5. SHARES OF COMMON STOCK SUBJECT TO PLAN
(a) Shares Available for Awards. The Common Stock that may be issued pursuant to
Awards granted under the Plan shall be treasury shares or authorized but unissued shares of the
Common Stock. The total number of shares of Common Stock that may be issued pursuant to Awards
granted under the Plan shall be One Million Five Hundred Thousand (1,500,000) shares.
(b)
Maximum Shares Issuable During a Fiscal Year. The maximum number of shares of
Common Stock that may be issued under all Awards granted in a fiscal year shall not exceed three
percent (3%) of the Companys maximum authorized and outstanding shares of Common Stock at any time
during said fiscal year; provided, however, that (i) such limitation shall not include any
substitute grants made in settlement of any awards under any other plan sponsored by the Company or
substitute grants or equity assumed in connection with a corporate
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transaction, and (ii) any shares of Common Stock repurchased or redeemed by the Company after
any Awards have been made which have been authorized by the Board shall nevertheless be deemed to
be outstanding for purposes of calculating whether there has been a violation of this Section 5(b).
(c) Certain Limitations on Specific Types of Awards. The granting of Awards under
this Plan shall be subject to the following limitations:
(i) With respect to the shares of Common Stock reserved pursuant to this Section, a
maximum of One Million Five Hundred Thousand (1,500,000) of such shares may be subject to
grants of Incentive Stock Options;
(ii) With respect to the shares of Common Stock reserved pursuant to this Section, a
maximum of One Million Five Hundred Thousand (1,500,000) of such shares may be issued in
connection with Awards, other than Stock Options and Stock Appreciation Rights, that are
settled in Common Stock;
(iii) With respect to the shares of Common Stock reserved pursuant to this Section, a
maximum of Two Hundred Thousand (200,000) of such shares may be subject to grants of Options
or Stock Appreciation Rights to any one Eligible Individual during any one fiscal year;
(iv) With respect to the shares of Common Stock reserved pursuant to this Section, a
maximum of Two Hundred Thousand (200,000) of such shares may be subject to grants of
Performance Shares, Restricted Stock, and Awards of Common Stock to any one Eligible
Individual during any one fiscal year; and
(v) The maximum value at Grant Date of grants of Performance Units which may be granted
to any one Eligible Individual during any one fiscal year shall be $200,000.
(d) Reduction of Shares Available for Awards. Upon the granting of an Award, the
number of shares of Common Stock available under this Section hereof for the granting of further
Awards shall be reduced as follows:
(i) In connection with the granting of an Option or Stock Appreciation Right, the
number of shares of Common Stock shall be reduced by the number of shares of Common Stock
subject to the Option or Stock Appreciation Right;
(ii) In connection with the granting of an Award that is settled in Common Stock, other
than the granting of an Option or Stock Appreciation Right, the number of shares of Common
Stock shall be reduced by the number of shares of Common Stock subject to the Award; and
(iii) Awards settled in cash shall not count against the total number of shares of
Common Stock available to be granted pursuant to the Plan.
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(e) Cancelled, Forfeited, or Surrendered Awards. Notwithstanding anything to the
contrary in this Plan, if any Award is cancelled, forfeited or terminated for any reason prior to
exercise or becoming vested in full, the shares of Common Stock that were subject to such Award
shall, to the extent cancelled, forfeited or terminated, immediately become available for future
Awards granted under the Plan as if said Award had never been granted; provided, however, that any
shares of Common Stock subject to an Award which is cancelled, forfeited or terminated in order to
pay the Exercise Price, purchase price or any taxes or tax withholdings on an Award shall not be
available for future Awards granted under the Plan.
(f) Recapitalization. If the outstanding shares of Common Stock are increased or
decreased or changed into or exchanged for a different number or kind of shares or other securities
of the Company by reason of any recapitalization, reclassification, reorganization, stock split,
reverse split, combination of shares, exchange of shares, stock dividend or other distribution
payable in capital stock of the Company or other increase or decrease in such shares effected
without receipt of consideration by the Company occurring after the Effective Date, an appropriate
and proportionate adjustment shall be made by the Committee to (i) the aggregate number and kind of
shares of Common Stock available under the Plan, (ii) the aggregate limit of the number of shares
of Common Stock that may be granted pursuant to an Incentive Stock Option, (iii) the limits on the
number of shares of Common Stock that may be granted to an Eligible Employee in any one fiscal
year, (iv) the calculation of the reduction of shares of Common Stock available under the Plan, (v)
the number and kind of shares of Common Stock issuable upon exercise (or vesting) of outstanding
Awards granted under the Plan; (vi) the Exercise Price of outstanding Options granted under the
Plan, and/or (vii) the number of shares of Common Stock subject to Awards granted to Non-Employee
Directors under Section 10. No fractional shares of Common Stock or units of other securities
shall be issued pursuant to any such adjustment under this Section 5(f), and any fractions
resulting from any such adjustment shall be eliminated in each case by rounding downward to the
nearest whole share or unit. Any adjustments made under this Section 5(f) with respect to any
Incentive Stock Options must be made in accordance with Code Section 424.
6. OPTIONS
(a) Grant of Options. Subject to the terms and conditions of the Plan, the Committee
may grant to such Eligible Individuals as the Committee may determine, Options to purchase such
number of shares of Common Stock and on such terms and conditions as the Committee shall determine
in its sole and absolute discretion. Each grant of an Option shall satisfy the requirements set
forth in this Section.
(b) Type of Options. Each Option granted under the Plan may be designated by the
Committee, in its sole discretion, as either (i) an Incentive Stock Option, or (ii) a Non-Qualified
Stock Option. Options designated as Incentive Stock Options that fail to continue to meet the
requirements of Code Section 422 shall be re-designated as Non-Qualified Stock Options
automatically on the date of such failure to continue to meet such requirements without further
action by the Committee. In the absence of any designation, Options granted under the Plan will be
deemed to be Non-Qualified Stock Options.
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(c) Exercise Price. Subject to the limitations set forth in the Plan relating to
Incentive Stock Options, the Exercise Price of an Option shall be fixed by the Committee and stated
in the respective Award Agreement, provided that the Exercise Price of the shares of Common Stock
subject to such Option may not be less than Fair Market Value of such Common Stock on the Grant
Date, or if greater, the par value of the Common Stock.
(d) Limitation on Repricing. Unless such action is approved by the Companys
shareholders in accordance with applicable law: (i) no outstanding Option granted under the Plan
may be amended to provide an Exercise Price that is lower than the then-current Exercise Price of
such outstanding Option (other than adjustments to the Exercise Price pursuant to Sections 5(f) and
12); (ii) the Committee may not cancel any outstanding Option and grant in substitution therefore
new Awards under the Plan covering the same or a different number of shares of Common Stock and
having an Exercise Price lower than the then-current Exercise Price of the cancelled Option (other
than adjustments to the Exercise Price pursuant to Sections 5(f) and 12); and (iii) the Committee
may not authorize the repurchase of an outstanding Option which has an Exercise Price that is
higher than the then-current fair market value of the Common Stock (other than adjustments to the
Exercise Price pursuant to Sections 5(f) and 12).
(e) Limitation on Option Period. Subject to the limitations set forth in the Plan
relating to Incentive Stock Options, Options granted under the Plan and all rights to purchase
Common Stock thereunder shall terminate no later than the tenth anniversary of the Grant Date of
such Options, or on such earlier date as may be stated in the Award Agreement relating to such
Option. In the case of Options expiring prior to the tenth anniversary of the Grant Date, the
Committee may in its discretion, at any time prior to the expiration or termination of said
Options, extend the term of any such Options for such additional period as it may determine, but in
no event beyond the tenth anniversary of the Grant Date thereof.
(f) Limitations on Incentive Stock Options. Notwithstanding any other provisions of
the Plan, the following provisions shall apply with respect to Incentive Stock Options granted
pursuant to the Plan.
(i) Limitation on Grants. Incentive Stock Options may only be granted to
Section 424 Employees. The aggregate Fair Market Value (determined at the time such
Incentive Stock Option is granted) of the shares of Common Stock for which any individual
may have Incentive Stock Options which first become vested and exercisable in any calendar
year (under all incentive stock option plans of the Company) shall not exceed $100,000.
Options granted to such individual in excess of the $100,000 limitation, and any Options
issued subsequently which first become vested and exercisable in the same calendar year,
shall automatically be treated as Non-Qualified Stock Options.
(ii) Minimum Exercise Price. In no event may the Exercise Price of a share of
Common Stock subject an Incentive Stock Option be less than 100% of the Fair Market Value of
such share of Common Stock on the Grant Date.
(iii) Ten Percent Shareholder. Notwithstanding any other provision of the Plan
to the contrary, in the case of Incentive Stock Options granted to a Section 424
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Employee who, at the time the Option is granted, owns (after application of the rules
set forth in Code Section 424(d)) stock possessing more than ten percent of the total
combined voting power of all classes of stock of the Company, such Incentive Stock Options
(i) must have an Exercise Price per share of Common Stock that is at least 110% of the Fair
Market Value as of the Grant Date of a share of Common Stock, and (ii) must not be
exercisable after the fifth anniversary of the Grant Date.
(g) Vesting Schedule and Conditions. No Options may be exercised prior to the
satisfaction of the conditions and vesting schedule provided for in the Award Agreement relating
thereto. Except as otherwise provided by the Committee in an Award Agreement in its sole and
absolute discretion, subject to Sections 10, 12 and 13 of the Plan, Options covered by any Award
under this Plan that are subject solely to a future service requirement shall vest as follows: [(i)
20% of the Options subject to an Award shall vest immediately upon the Grant Date; and (ii) the
remaining 80% of the Options subject to an Award shall vest over the four-year period immediately
following the Grant Date in equal annual increments of 20%, with one increment vesting on each
anniversary date of the Grant Date.]
(h) Exercise. When the conditions to the exercise of an Option have been satisfied,
the Participant may exercise the Option only in accordance with the following provisions. The
Participant shall deliver to the Company a written notice stating that the Participant is
exercising the Option and specifying the number of shares of Common Stock which are to be purchased
pursuant to the Option, and such notice shall be accompanied by payment in full of the Exercise
Price of the shares for which the Option is being exercised, by one or more of the methods provided
for in the Plan. Said notice must be delivered to the Company at its principal office and
addressed to the attention of Patrick J. McEnany, Chief Executive Officer. An attempt to exercise
any Option granted hereunder other than as set forth in the Plan shall be invalid and of no force
and effect.
(i) Payment. Payment of the Exercise Price for the shares of Common Stock purchased
pursuant to the exercise of an Option shall be made by one of the following methods:
(i) by cash, certified or cashiers check, bank draft or money order;
(ii) through the delivery to the Company of shares of Common Stock which have been
previously owned by the Participant for the requisite period necessary to avoid a charge to
the Companys earnings for financial reporting purposes; such shares shall be valued, for
purposes of determining the extent to which the Exercise Price has been paid thereby, at
their Fair Market Value on the date of exercise; without limiting the foregoing, the
Committee may require the Participant to furnish an opinion of counsel acceptable to the
Committee to the effect that such delivery would not result in the Company incurring any
liability under Section 16(b) of the Exchange Act; or
(iii) by any other method which the Committee, in its sole and absolute discretion and
to the extent permitted by applicable law, may permit, including, but not limited to, any of
the following: (A) through a cashless exercise sale and remittance procedure pursuant to
which the Participant shall concurrently provide irrevocable instructions (1) to a brokerage
firm approved by the Committee to effect the immediate
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sale of the purchased shares and remit to the Company, out of the sale proceeds
available on the settlement date, sufficient funds to cover the aggregate Exercise Price
payable for the purchased shares plus all applicable federal, state and local income,
employment, excise, foreign and other taxes required to be withheld by the Company by reason
of such exercise and (2) to the Company to deliver the certificates for the purchased shares
directly to such brokerage firm in order to complete the sale; or (B) by any other method as
may be permitted by the Committee.
(j) Termination of Employment, Disability or Death. Unless otherwise provided in an
Award Agreement, upon the termination of the employment or other service of a Participant with
Company for any reason, all of the Participants outstanding Options (whether vested or unvested)
shall be subject to the rules of this paragraph. Upon such termination, the Participants unvested
Options shall expire. Notwithstanding anything in this Plan to the contrary, the Committee may
provide, in its sole and absolute discretion, that following the termination of employment or other
service of a Participant with the Company for any reason (i) any unvested Options held by the
Participant that vest solely upon a future service requirement shall vest in whole or in part, at
any time subsequent to such termination of employment or other service, and or (ii) a Participant
or the Participants estate, devisee or heir at law (whichever is applicable), may exercise an
Option, in whole or in part, at any time subsequent to such termination of employment or other
service and prior to the termination of the Option pursuant to its terms. Unless otherwise
determined by the Committee, temporary absence from employment because of illness, vacation,
approved leaves of absence or military service shall not constitute a termination of employment or
other service.
(i) Termination for Reason Other Than Cause, Disability or Death. If a
Participants termination of employment or other service is for any reason other than death,
Disability, Cause or a voluntary termination within ninety (90) days after occurrence of an
event which would be grounds for termination of employment or other service by the Company
for Cause, any Option held by such Participant, may be exercised, to the extent exercisable
at termination, by the Participant at any time within a period not to exceed ninety (90)
days from the date of such termination, but in no event after the termination of the Option
pursuant to its terms.
(ii) Disability. If a Participants termination of employment or other service
with the Company is by reason of a Disability of such Participant, the Participant shall
have the right at any time within a period not to exceed one (1) year after such
termination, but in no event after the termination of the Option pursuant to its terms, to
exercise, in whole or in part, any vested portion of the Option held by such Participant at
the date of such termination; provided, however, that if the Participant dies within such
period, any vested Option held by such Participant upon death shall be exercisable by the
Participants estate, devisee or heir at law (whichever is applicable) for a period not to
exceed one (1) year after the Participants death, but in no event after the termination of
the Option pursuant to its terms.
(iii) Death. If a Participant dies while in the employment or other service of
the Company, the Participants estate or the devisee named in the Participants valid last
will and testament or the Participants heir at law who inherits the Option has
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the right, at any time within a period not to exceed one (1) year after the date of
such Participants death, but in no event after the termination of the Option pursuant to
its terms, to exercise, in whole or in part, any portion of the vested Option held by such
Participant at the date of such Participants death.
(iv) Termination for Cause. In the event the termination is for Cause or is a
voluntary termination within ninety (90) days after occurrence of an event which would be
grounds for termination of employment or other service by the Company for Cause (without
regard to any notice or cure period requirement), any Option held by the Participant at the
time of such termination shall be deemed to have terminated and expired upon the date of
such termination.
7. STOCK APPRECIATION RIGHTS
(a) Grant of Stock Appreciation Rights. Subject to the terms and conditions of the
Plan, the Committee may grant to such Eligible Individuals as the Committee may determine, Stock
Appreciation Rights, in such amounts and on such terms and conditions as the Committee shall
determine in its sole and absolute discretion. Each grant of a Stock Appreciation Right shall
satisfy the requirements as set forth in this Section.
(b) Terms and Conditions of Stock Appreciation Rights. Unless otherwise provided in
an Award Agreement, the terms and conditions (including, without limitation, the limitations on the
Exercise Price, exercise period, repricing and termination) of the Stock Appreciation Right shall
be substantially identical (to the extent possible taking into account the differences related to
the character of the Stock Appreciation Right) to the terms and conditions that would have been
applicable under Section 6 above were the grant of the Stock Appreciation Rights a grant of an
Option.
(c) Exercise of Stock Appreciation Rights. Stock Appreciation Rights shall be
exercised by a Participant only by written notice delivered to the Chief Executive Officer of the
Company, specifying the number of shares of Common Stock with respect to which the Stock
Appreciation Right is being exercised.
(d) Payment of Stock Appreciation Right. Unless otherwise provided in an Award
Agreement, upon exercise of a Stock Appreciation Right, the Participant or Participants estate,
devisee or heir at law (whichever is applicable) shall be entitled to receive payment, in cash, in
shares of Common Stock, or in a combination thereof, as determined by the Committee in its sole and
absolute discretion. The amount of such payment shall be determined by multiplying the excess, if
any, of the Fair Market Value of a share of Common Stock on the date of exercise over the Fair
Market Value of a share of Common Stock on the Grant Date, by the number of shares of Common Stock
with respect to which the Stock Appreciation Rights are then being exercised. Notwithstanding the
foregoing, the Committee may limit in any manner the amount payable with respect to a Stock
Appreciation Right by including such limitation in the Award Agreement.
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8. RESTRICTED STOCK
(a) Grant of Restricted Stock. Subject to the terms and conditions of the Plan, the
Committee may grant to such Eligible Individuals as the Committee may determine, Restricted Stock,
in such amounts and on such terms and conditions as the Committee shall determine in its sole and
absolute discretion. Each grant of Restricted Stock shall satisfy the requirements as set forth in
this Section.
(b) Restrictions. The Committee shall impose such restrictions on any Restricted
Stock granted pursuant to the Plan as it may deem advisable including, without limitation; time
based vesting restrictions, or the attainment of Performance Goals. Except as otherwise provided
by the Committee in an Award Agreement in its sole and absolute discretion, subject to Sections 10,
12 and 13 of the Plan, Restricted Stock covered by any Award under this Plan that are subject
solely to a future service requirement shall vest over the [four-year period immediately following
the Grant Date in equal annual increments of 25%, with one increment vesting on each anniversary
date of the Grant Date.] Shares of Restricted Stock subject to the attainment of Performance Goals
will be released from restrictions only after the attainment of such Performance Goals has been
certified by the Committee in accordance with Section 9(c).
(c) Certificates and Certificate Legend. With respect to a grant of Restricted Stock,
the Company may issue a certificate evidencing such Restricted Stock to the Participant or issue
and hold such shares of Restricted Stock for the benefit of the Participant until the applicable
restrictions expire. The Company may legend the certificate representing Restricted Stock to give
appropriate notice of such restrictions. In addition to any such legends, each certificate
representing shares of Restricted Stock granted pursuant to the Plan shall bear the following
legend:
The sale or other transfer of the shares of stock represented by this
certificate, whether voluntary, involuntary, or by operation of law, are
subject to certain terms, conditions, and restrictions on transfer as set
forth in the Catalyst Pharmaceutical Partners, Inc. 2006 Stock Incentive
Plan (the Plan), and in an Agreement entered into by and between the
registered owner of such shares and Catalyst Pharmaceutical Partners, Inc.
(the Company), dated ___(the Award Agreement). A copy of the
Plan and the Award Agreement may be obtained from the Secretary of the
Company.
(d) Removal of Restrictions. Except as otherwise provided in the Plan, shares of
Restricted Stock shall become freely transferable by the Participant upon the lapse of the
applicable restrictions. Once the shares of Restricted Stock are released from the restrictions,
the Participant shall be entitled to have the legend required by paragraph (c) above removed from
the share certificate evidencing such Restricted Stock and the Company shall pay or distribute to
the Participant all dividends and distributions held in escrow by the Company with respect to such
Restricted Stock.
(e)
Shareholder Rights. Unless otherwise provided in an Award Agreement, until the
expiration of all applicable restrictions, (i) the Restricted Stock shall be treated as
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outstanding, (ii) the Participant holding shares of Restricted Stock may exercise full voting
rights with respect to such shares, and (iii) the Participant holding shares of Restricted Stock
shall be entitled to receive all dividends and other distributions paid with respect to such shares
while they are so held. If any such dividends or distributions are paid in shares of Common Stock,
such shares shall be subject to the same restrictions on transferability and forfeitability as the
shares of Restricted Stock with respect to which they were paid. Notwithstanding anything to the
contrary, at the discretion of the Committee, all such dividends and distributions may be held in
escrow by the Company (subject to the same restrictions on forfeitability) until all restrictions
on the respective Restricted Stock have lapsed.
(f) Termination of Service. Unless otherwise provided in a Award Agreement, if a
Participants employment or other service with the Company terminates for any reason, all unvested
shares of Restricted Stock held by the Participant and any dividends or distributions held in
escrow by the Company with respect to such Restricted Stock shall be forfeited immediately and
returned to the Company. Notwithstanding this paragraph, all grants of Restricted Stock that vest
solely upon the attainment of Performance Goals shall be treated pursuant to the terms and
conditions that would have been applicable under Section 9(c) as if such grants of Restricted Stock
were Awards of Performance Shares. Notwithstanding anything in this Plan to the contrary, the
Committee may provide, in its sole and absolute discretion, that following the termination of
employment or other service of a Participant with the Company for any reason, any unvested shares
of Restricted Stock held by the Participant that vest solely upon a future service requirement
shall vest in whole or in part, at any time subsequent to such termination of employment or other
service.
9. PERFORMANCE SHARES AND PERFORMANCE UNITS
(a) Grant of Performance Shares and Performance Units. Subject to the terms and
conditions of the Plan, the Committee may grant to such Eligible Individuals as the Committee may
determine, Performance Shares and Performance Units, in such amounts and on such terms and
conditions as the Committee shall determine in its sole and absolute discretion. Each grant of a
Performance Share or a Performance Unit shall satisfy the requirements as set forth in this
Section.
(b)
Performance Goals. Performance Goals will be based on one or more of the
following criteria, as determined by the Committee in its absolute and sole discretion: (i) the
attainment of certain target levels of, or a specified increase in, the Companys enterprise value
or value creation targets; (ii) the attainment of certain target levels of, or a percentage
increase in, the Companys after-tax or pre-tax profits including, without limitation, that
attributable to the Companys continuing and/or other operations; (iii) the attainment of certain
target levels of, or a specified increase relating to, the Companys operational cash flow or
working capital, or a component thereof; (iv) the attainment of certain target levels of, or a
specified decrease relating to, the Companys operational costs, or a component thereof (v) the
attainment of a certain level of reduction of, or other specified objectives with regard to
limiting the level of increase in all or a portion of bank debt or other of the Companys long-term
or short-term public or private debt or other similar financial obligations of the Company, which
may be calculated net of cash balances and/or other offsets and adjustments as may be established
by the Committee; (vi) the attainment of a specified percentage increase in earnings per share or
earnings per share from the
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Companys continuing operations; (vii) the attainment of certain target levels of, or a
specified percentage increase in, the Companys net sales, revenues, net income or earnings before
income tax or other exclusions; (viii) the attainment of certain target levels of, or a specified
increase in, the Companys return on capital employed or return on invested capital; (ix) the
attainment of certain target levels of, or a percentage increase in, the Companys after-tax or
pre-tax return on shareholder equity; (x) the attainment of certain target levels in the fair
market value of the Companys Common Stock; (xi) the growth in the value of an investment in the
Common Stock assuming the reinvestment of dividends; and/or (xii) the attainment of certain target
levels of, or a specified increase in, EBITDA (earnings before income tax, depreciation and
amortization). In addition, Performance Goals may be based upon the attainment by a subsidiary,
division or other operational unit of the Company of specified levels of performance under one or
more of the measures described above. Further, the Performance Goals may be based upon the
attainment by the Company (or a subsidiary, division, facility or other operational unit of the
Company) of specified levels of performance under one or more of the foregoing measures relative to
the performance of other corporations. To the extent permitted under Code Section 162(m) of the
Code (including, without limitation, compliance with any requirements for shareholder approval),
the Committee may, in its sole and absolute discretion: (i) designate additional business criteria
upon which the Performance Goals may be based; (ii) modify, amend or adjust the business criteria
described herein; or (iii) incorporate in the Performance Goals provisions regarding changes in
accounting methods, corporate transactions (including, without limitation, dispositions or
acquisitions) and similar events or circumstances. Performance Goals may include a threshold level
of performance below which no Award will be earned, levels of performance at which an Award will
become partially earned and a level at which an Award will be fully earned.
(c) Terms and Conditions of Performance Shares and Performance Units. The applicable
Award Agreement shall set forth (i) the number of Performance Shares or the dollar value of
Performance Units granted to the Participant; (ii) the Performance Period and Performance Goals
with respect to each such Award; (iii) the threshold, target and maximum shares of Common Stock or
dollar values of each Performance Share or Performance Unit and corresponding Performance Goals,
and (iv) any other terms and conditions as the Committee determines in its sole and absolute
discretion. The Committee shall establish, in its sole and absolute discretion, the Performance
Goals for the applicable Performance Period for each Performance Share or Performance Unit granted
hereunder. Performance Goals for different Participants and for different grants of Performance
Shares and Performance Units need not be identical. Unless otherwise provided in an Award
Agreement, the Participants rights as a shareholder in Performance Shares shall be substantially
identical to the terms and conditions that would have been applicable under Section 8 above if the
Performance Shares were Restricted Stock. Unless otherwise provided in an Award Agreement, a
holder of Performance Units is not entitled to the rights of a holder of our Common Stock.
(d)
Determination and Payment of Performance Units or Performance Shares Earned. As
soon as practicable after the end of a Performance Period, the Committee shall determine the extent
to which Performance Shares or Performance Units have been earned on the basis of the Companys
actual performance in relation to the established Performance Goals as set forth in the applicable
Award Agreement and shall certify these results in writing. As soon as practicable after the
Committee has determined that an amount is payable or should be
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distributed with respect to a Performance Share or a Performance Unit, the Committee shall
cause the amount of such Award to be paid or distributed to the Participant or the Participants
estate, devisee or heir at law (whichever is applicable). Unless otherwise provided in an Award
Agreement, the Committee shall determine in its sole and absolute discretion whether payment with
respect to the Performance Share or Performance Unit shall be made in cash, in shares of Common
Stock, or in a combination thereof. For purposes of making payment or a distribution with respect
to a Performance Share or Performance Unit, the cash equivalent of a share of Common Stock shall be
determined by the Fair Market Value of the Common Stock on the day the Committee designates the
Performance Shares or Performance Units to be payable.
(e) Termination of Employment. Unless otherwise provided in an Award Agreement, if a
Participants employment or other service with the Company terminates for any reason, all of the
Participants outstanding Performance Shares and Performance Units shall be subject to the rules of
this Section.
(i) Termination for Reason Other Than Death or Disability. If a Participants
employment or other service with the Company terminates prior to the expiration of a
Performance Period with respect to any Performance Units or Performance Shares held by such
Participant for any reason other than death or Disability, the outstanding Performance Units
or Performance Shares held by such Participant for which the Performance Period has not yet
expired shall terminate upon such termination and the Participant shall have no further
rights pursuant to such Performance Units or Performance Shares.
(ii) Termination of Employment for Death or Disability. If a Participants
employment or other service with the Company terminates by reason of the Participants death
or Disability prior to the end of a Performance Period, the Participant, or the
Participants estate, devisee or heir at law (whichever is applicable) shall be entitled to
a payment of the Participants outstanding Performance Units and Performance Share at the
end of the applicable Performance Period, pursuant to the terms of the Plan and the
Participants Award Agreement; provided, however, that the Participant shall be deemed to
have earned only that proportion (to the nearest whole unit or share) of the Performance
Units or Performance Shares granted to the Participant under such Award as the number of
full months of the Performance Period which have elapsed since the first day of the
Performance Period for which the Award was granted to the end of the month in which the
Participants termination of employment or other service, bears to the total number of
months in the Performance Period, subject to the attainment of the Performance Goals
associated with the Award as certified by the Committee. The right to receive any remaining
Performance Units or Performance Shares shall be canceled and forfeited.
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10. VESTING OF AWARD GRANTS TO NON-EMPLOYEE DIRECTORS
Notwithstanding the minimum vesting provisions in Section 6(g) and 8(b) of the Plan, any Award
granted to a Non-Employee Director in lieu of cash compensation shall not be subject to any minimum
vesting requirements.
11. OTHER AWARDS
Awards of shares of Common Stock, phantom stock, restricted stock units and other awards that
are valued in whole or in part by reference to, or otherwise based on, Common Stock, may also be
made, from time to time, to Eligible Individuals as may be selected by the Committee. Such Common
Stock may be issued in satisfaction of awards granted under any other plan sponsored by the Company
or compensation payable to an Eligible Individual. In addition, such awards may be made alone or
in addition to or in connection with any other Award granted hereunder. The Committee may
determine the terms and conditions of any such award. Each such award shall be evidenced by an
Award Agreement between the Eligible Individual and the Company which shall specify the number of
shares of Common Stock subject to the award, any consideration therefore, any vesting or
performance requirements and such other terms and conditions as the Committee shall determine in
its sole and absolute discretion.
12. CHANGE IN CONTROL
Unless otherwise provided in an Award Agreement, upon the occurrence of a Change in Control of
the Company, the Committee may in its sole and absolute discretion, provide on a case by case basis
that (i) some or all outstanding Awards may become immediately exercisable or vested, without
regard to any limitation imposed pursuant to this Plan, (ii) that all Awards shall terminate,
provided that Participants shall have the right, immediately prior to the occurrence of such Change
in Control and during such reasonable period as the Committee in its sole discretion shall
determine and designate, to exercise any vested Award in whole or in part, (iii) that all Awards
shall terminate, provided that Participants shall be entitled to a cash payment equal to the Change
in Control Price with respect to shares subject to the vested portion of the Award net of the
Exercise Price thereof (if applicable), (iv) provide that, in connection with a liquidation or
dissolution of the Company, Awards shall convert into the right to receive liquidation proceeds net
of the Exercise Price (if applicable) and (v) any combination of the foregoing. In the event that
the Committee does not terminate or convert an Award upon a Change in Control of the Company, then
the Award shall be assumed, or substantially equivalent Awards shall be substituted, by the
acquiring, or succeeding corporation (or an affiliate thereof).
13. CHANGE IN STATUS OF PARENT OR SUBSIDIARY
Unless otherwise provided in an Award Agreement or otherwise determined by the Committee, in
the event that an entity or business unit which was previously a part of the Company is no longer a
part of the Company, as determined by the Committee in its sole discretion, the Committee may, in
its sole and absolute discretion: (i) provide on a case by case basis that some or all outstanding
Awards held by a Participant employed by or performing service for such entity or business unit may
become immediately exercisable or vested, without regard to any limitation imposed pursuant to this
Plan; (ii) provide on a case by case basis that
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some or all outstanding Awards held by a Participant employed by or performing service for
such entity or business unit may remain outstanding, may continue to vest, and/or may remain
exercisable for a period not exceeding one (1) year, subject to the terms of the Award Agreement
and this Plan; and/or (ii) treat the employment or other services of a Participant employed by such
entity or business unit as terminated if such Participant is not employed by the Company or any
entity that is a part of the Company immediately after such event.
14. REQUIREMENTS OF LAW
(a) Violations of Law. The Company shall not be required to sell or issue any shares
of Common Stock under any Award if the sale or issuance of such shares would constitute a violation
by the individual exercising the Award, the Participant or the Company of any provisions of any law
or regulation of any governmental authority, including without limitation any provisions of the
Sarbanes-Oxley Act, and any other federal or state securities laws or regulations. Any
determination in this connection by the Committee shall be final, binding, and conclusive. The
Company shall not be obligated to take any affirmative action in order to cause the exercise of an
Award, the issuance of shares pursuant thereto or the grant of an Award to comply with any law or
regulation of any governmental authority.
(b) Registration. At the time of any exercise or receipt of any Award, the Company
may, if it shall determine it necessary or desirable for any reason, require the Participant (or
Participants heirs, legatees or legal representative, as the case may be), as a condition to the
exercise or grant thereof, to deliver to the Company a written representation of present intention
to hold the shares for their own account as an investment and not with a view to, or for sale in
connection with, the distribution of such shares, except in compliance with applicable federal and
state securities laws with respect thereto. In the event such representation is required to be
delivered, an appropriate legend may be placed upon each certificate delivered to the Participant
(or Participants heirs, legatees or legal representative, as the case may be) upon the
Participants exercise of part or all of the Award or receipt of an Award and a stop transfer order
may be placed with the transfer agent. Each Award shall also be subject to the requirement that,
if at any time the Company determines, in its discretion, that the listing, registration or
qualification of the shares subject to the Award upon any securities exchange or under any state or
federal law, or the consent or approval of any governmental regulatory body, is necessary or
desirable as a condition of or in connection with, the issuance or purchase of the shares
thereunder, the Award may not be exercised in whole or in part and the restrictions on an Award may
not be removed unless such listing, registration, qualification, consent or approval shall have
been effected or obtained free of any conditions not acceptable to the Company in its sole
discretion. The Participant shall provide the Company with any certificates, representations and
information that the Company requests and shall otherwise cooperate with the Company in obtaining
any listing, registration, qualification, consent or approval that the Company deems necessary or
appropriate. The Company shall not be obligated to take any affirmative action in order to cause
the exercisability or vesting of an Award, to cause the exercise of an Award or the issuance of
shares pursuant thereto, or to cause the grant of Award to comply with any law or regulation of any
governmental authority.
(c)
Withholding. The Committee may make such provisions and take such steps as it may
deem necessary or appropriate for the withholding of any taxes that the Company
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is required by any law or regulation of any governmental authority, whether federal, state or
local, domestic or foreign, to withhold in connection with the grant or exercise of an Award, or
the removal of restrictions on an Award including, but not limited to: (i) the withholding of
delivery of shares of Common Stock until the holder reimburses the Company for the amount the
Company is required to withhold with respect to such taxes; (ii) the canceling of any number of
shares of Common Stock issuable in an amount sufficient to reimburse the Company for the amount it
is required to so withhold; (iii) withholding the amount due from any such persons wages or
compensation due to such person; or (iv) requiring the Participant to pay the Company cash in the
amount the Company is required to withhold with respect to such taxes.
(d) Governing Law. The Plan shall be governed by, and construed and enforced in
accordance with, the laws of the State of Florida.
15. GENERAL PROVISIONS
(a) Award Agreements. All Awards granted pursuant to the Plan shall be evidenced by
an Award Agreement. Each Award Agreement shall specify the terms and conditions of the Award
granted and shall contain any additional provisions as the Committee shall deem appropriate, in its
sole and absolute discretion (including, to the extent that the Committee deems appropriate,
provisions relating to confidentiality, non-competition, non-solicitation and similar matters).
The terms of each Award Agreement need not be identical for Eligible Individuals provided that all
Award Agreements comply with the terms of the Plan.
(b) Purchase Price. To the extent the purchase price of any Award granted hereunder
is less than par value of a share of Common Stock and such purchase price is not permitted by
applicable law, the per share purchase price shall be deemed to be equal to the par value of a
share of Common Stock.
(c) Dividends and Dividend Equivalents. Except as provided by the Committee in its
sole and absolute discretion or as otherwise provided in Section 5(f) and subject to Section 8(e)
of the Plan, a Participant shall not be entitled to receive, currently or on a deferred basis, cash
or stock dividends, Dividend Equivalents, or cash payments in amounts equivalent to cash or stock
dividends on shares of Commons Stock covered by an Award which has not vested or an Option. The
Committee in its absolute and sole discretion may credit a Participants Award with Dividend
Equivalents with respect to any Awards. To the extent that dividends and distributions relating to
an Award are held in escrow by the Company, or Dividend Equivalents are credited to an Award, a
Participant shall not be entitled to any interest on any such amounts. The Committee may not grant
Dividend Equivalents to an Award subject to performance-based vesting to the extent that the grant
of such Dividend Equivalents would limit the Companys deduction of the compensation payable under
such Award for federal tax purposes pursuant to Code Section 162(m).
(d)
Deferral of Awards. The Committee may from time to time establish procedures
pursuant to which a Participant may elect to defer, until a time or times later than the vesting
of an Award, receipt of all or a portion of the shares of Common Stock or cash subject to such
Award and to receive Common Stock or cash at such later time or times, all on such terms and
conditions as the Committee shall determine. The Committee shall not permit the deferral of
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an Award unless counsel for the Company determines that such action will not result in adverse
tax consequences to a Participant under Section 409A of the Code. If any such deferrals are
permitted, then notwithstanding anything to the contrary herein, a Participant who elects to defer
receipt of Common Stock shall not have any rights as a shareholder with respect to deferred shares
of Common Stock unless and until shares of Common Stock are actually delivered to the Participant
with respect thereto, except to the extent otherwise determined by the Committee.
(e) Prospective Employees. Notwithstanding anything to the contrary, any Award
granted to a Prospective Employee shall not become vested prior to the date the Prospective
Employee first becomes an employee of the Company.
(f) Issuance of Certificates; Shareholder Rights. The Company shall deliver to the
Participant a certificate evidencing the Participants ownership of shares of Common Stock issued
pursuant to the exercise of an Award as soon as administratively practicable after satisfaction of
all conditions relating to the issuance of such shares. A Participant shall not have any of the
rights of a shareholder with respect to such Common Stock prior to satisfaction of all conditions
relating to the issuance of such Common Stock, and, except as expressly provided in the Plan, no
adjustment shall be made for dividends, distributions or other rights of any kind for which the
record date is prior to the date on which all such conditions have been satisfied.
(g) Transferability of Awards. A Participant may not Transfer an Award other than by
will or the laws of descent and distribution. Awards may be exercised during the Participants
lifetime only by the Participant. No Award shall be liable for or subject to the debts, contracts,
or liabilities of any Participant, nor shall any Award be subject to legal process or attachment
for or against such person. Any purported Transfer of an Award in contravention of the provisions
of the Plan shall have no force or effect and shall be null and void, and the purported transferee
of such Award shall not acquire any rights with respect to such Award. Notwithstanding anything to
the contrary, the Committee may in its sole and absolute discretion permit the Transfer of an Award
to a Participants family member as such term is defined in the Form 8 Registration Statement
under the Securities Act of 1933, as amended, under such terms and conditions as specified by the
Committee. In such case, such Award shall be exercisable only by the transferee approved of by the
Committee. To the extent that the Committee permits the Transfer of an Incentive Stock Option to a
family member, so that such Option fails to continue to satisfy the requirements of an incentive
stock option under the Code such Option shall automatically be re-designated as a Non-Qualified
Stock Option.
(h) Buyout and Settlement Provisions. Except as prohibited in Section 6(d) of the
Plan, the Committee may at any time on behalf of the Company offer to buy out any Awards previously
granted based on such terms and conditions as the Committee shall determine which shall be
communicated to the Participants at the time such offer is made.
(i) Use of Proceeds. The proceeds received by the Company from the sale of Common
Stock pursuant to Awards granted under the Plan shall constitute general funds of the Company.
(j)
Modification or Substitution of an Award. Subject to the terms and conditions of
the Plan, the Committee may modify outstanding Awards. Notwithstanding the
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following, no modification of an Award shall adversely affect any rights or obligations of the
Participant under the applicable Award Agreement without the Participants consent. The Committee
in its sole and absolute discretion may rescind, modify, or waive any vesting requirements or other
conditions applicable to an Award. Notwithstanding the foregoing, without the approval of the
shareholders of the Company in accordance with applicable law, an Award may not be modified to
reduce the exercise price thereof nor may an Award at a lower price be substituted for a surrender
of an Award, provided that (i) the foregoing shall not apply to adjustments or substitutions in
accordance with Section 5 or Section 12, and (ii) if an Award is modified, extended or renewed and
thereby deemed to be in issuance of a new Award under the Code or the applicable accounting rules,
the exercise price of such Award may continue to be the original Exercise Price even if less than
Fair Market Value of the Common Stock at the time of such modification, extension or renewal.
(k) Amendment and Termination of Plan. The Board may, at any time and from time to
time, amend, suspend or terminate the Plan as to any shares of Common Stock as to which Awards have
not been granted; provided, however, that the approval of the shareholders of the Company in
accordance with applicable law and the Articles of Incorporation and Bylaws of the Company shall be
required for any amendment: (i) that changes the class of individuals eligible to receive Awards
under the Plan: (ii) that increases the maximum number of shares of Common Stock in the aggregate
that may be subject to Awards that are granted under the Plan (except as permitted under Section 5
or Section 12 hereof): (iii) the approval of which is necessary to comply with federal or state law
(including without limitation Section 162(m) of the Code and Rule 16b-3 under the Exchange Act) or
with the rules of any stock exchange or automated quotation system on which the Common Stock may be
listed or traded; or (iv) that proposed to eliminate a requirement provided herein that the
shareholders of the Company must approve an action to be undertaken under the Plan. Except as
permitted under Section 5 or Section 12 hereof, no amendment, suspension or termination of the Plan
shall, without the consent of the holder of an Award, alter or impair rights or obligations under
any Award theretofore granted under the Plan. Awards granted prior to the termination of the Plan
may extend beyond the date the Plan is terminated and shall continue subject to the terms of the
Plan as in effect on the date the Plan is terminated.
(l) Section 409A of the Code. With respect to Awards subject to Section 409A of the
Code, this Plan is intended to comply with the requirements of such Section, and the provisions
hereof shall be interpreted in a manner that satisfies the requirements of such Section and the
related regulations, and the Plan shall be operated accordingly. If any provision of this Plan or
any term or condition of any Award would otherwise frustrate or conflict with this intent, the
provision, term or condition will be interpreted and deemed amended so as to avoid this conflict.
(m) Notification of 83(b) Election. If in connection with the grant of any Award, any
Participant makes an election permitted under Code Section 83(b), such Participant must notify the
Company in writing of such election within ten (10) days of filing such election with the Internal
Revenue Service.
(n)
[Detrimental Activity. All Awards shall be subject to cancellation by the
Committee in accordance with the terms of this Section 15(n) if the Participant engages in any
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Detrimental Activity. To the extent that a Participant engages in any Detrimental Activity at
any time prior to, or during the one year period after, any exercise or vesting of an Award but
prior to a Change in Control, the Company shall, upon the recommendation of the Committee, in its
sole and absolute discretion, be entitled to (i) immediately terminate and cancel any Awards held
by the Participant that have not yet been exercised, and/or (ii) with respect to Awards of the
Participant that have been previously exercised, recover from the Participant at any time within
two (2) years after such exercise but prior to a Change in Control (and the Participant shall be
obligated to pay over to the Company with respect to any such Award previously held by such
Participant): (A) with respect to any Options exercised, an amount equal to the excess of the Fair
Market Value of the Common Stock for which any Option was exercised over the Exercise Price paid
(regardless of the form by which payment was made) with respect to such Option; (B) with respect to
any Award other than an Option, any shares of Common Stock granted and vested pursuant to such
Award, and if such shares are not still owned by the Participant, the Fair Market Value of such
shares on the date they were issued, or if later, the date all vesting restrictions were satisfied;
and (C) any cash or other property (other than Common Stock) received by the Participant from the
Company pursuant to an Award. Without limiting the generality of the foregoing, in the event that
a Participant engages in any Detrimental Activity at any time prior to any exercise of an Award and
the Company exercises its remedies pursuant to this Section 15(n) following the exercise of such
Award, such exercise shall be treated as having been null and void, provided that the Company will
nevertheless be entitled to recover the amounts referenced above.]
(o) Disclaimer of Rights. No provision in the Plan, any Award granted hereunder, or
any Award Agreement entered into pursuant to the Plan shall be construed to confer upon any
individual the right to remain in the employ of or other service with the Company or to interfere
in any way with the right and authority of the Company either to increase or decrease the
compensation of any individual, including any holder of an Award, at any time, or to terminate any
employment or other relationship between any individual and the Company. The grant of an Award
pursuant to the Plan shall not affect or limit in any way the right or power of the Company to make
adjustments, reclassifications, reorganizations or changes of its capital or business structure or
to merge, consolidate, dissolve or liquidate, or to sell or transfer all or any part of its
business or assets.
(p) Unfunded Status of Plan. The Plan is intended to constitute an unfunded plan
for incentive and deferred compensation. With respect to any payments as to which a Participant
has a fixed and vested interest but which are not yet made to such Participant by the Company,
nothing contained herein shall give any such Participant any rights that are greater than those of
a general creditor of the Company.
(q) Nonexclusivity of Plan. The adoption of the Plan shall not be construed as
creating any limitations upon the right and authority of the Board to adopt such other incentive
compensation arrangements (which arrangements may be applicable either generally to a class or
classes of individuals or specifically to a particular individual or individuals) as the Board in
its sole and absolute discretion determines desirable.
(r)
Other Benefits. No Award payment under the Plan shall be deemed compensation for
purposes of computing benefits under any retirement plan of the Company or
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any agreement between a Participant and the Company, nor affect any benefits under any other
benefit plan of the Company now or subsequently in effect under which benefits are based upon a
Participants level of compensation.
(s) Headings. The section headings in the Plan are for convenience only; they form no
part of this Agreement and shall not affect its interpretation.
(t) Pronouns. The use of any gender in the Plan shall be deemed to include all
genders, and the use of the singular shall be deemed to include the plural and vice versa, wherever
it appears appropriate from the context.
(u) Successors and Assigns. The Plan shall be binding on all successors of the
Company and all successors and permitted assigns of a Participant, including, but not limited to, a
Participants estate, devisee, or heir at law.
(v) Severability. If any provision of the Plan or any Award Agreement shall be
determined to be illegal or unenforceable by any court of law in any jurisdiction, the remaining
provisions hereof and thereof shall be severable and enforceable in accordance with their terms,
and all provisions shall remain enforceable in any other jurisdiction.
(w) Notices. Any communication or notice required or permitted to be given under the
Plan shall be in writing, and mailed by registered or certified mail or delivered by hand, to the
Company, to its principal place of business, attention: Patrick J. McEnany, Chief Executive
Officer, and if to the holder of an Award, to the address as appearing on the records of the
Company.
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APPENDIX A
DEFINITIONS
Award means any Common Stock, Option, Performance Share, Performance Unit, Restricted Stock,
Stock Appreciation Right or any other award granted pursuant to the Plan.
Award Agreement means a written agreement entered into by the Company and a Participant
setting forth the terms and conditions of the grant of an Award to such Participant.
Board means the board of directors of the Company.
Cause means, with respect to a termination of employment or other service with the Company,
a termination of employment or other service due to a Participants dishonesty, fraud,
insubordination, willful misconduct, refusal to perform services (for any reason other than illness
or incapacity) or materially unsatisfactory performance of the Participants duties for the
Company; provided, however, that if the Participant and the Company have entered into an employment
agreement or consulting agreement which defines the term Cause, the term Cause shall be defined in
accordance with such agreement with respect to any Award granted to the Participant on or after the
effective date of the respective employment or consulting agreement. The Committee shall determine
in its sole and absolute discretion whether Cause exists for purposes of the Plan.
Change in Control shall be deemed to occur upon:
(a) any person as such term is used in Sections 13(d) and 14(d) of the Exchange Act (other
than the Company, any trustee or other fiduciary holding securities under any employee benefit plan
of the Company, any company owned, directly or indirectly, by the shareholders of the Company in
substantially the same proportions as their ownership of common stock of the Company, or [Patrick
J. McEnany and any group in which Patrick J. McEnany is a part]), is or becomes the beneficial
owner (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of
the Company representing fifty percent (50%) or more of the combined voting power of the Companys
then outstanding securities;
(b) during any period of two (2) consecutive years, individuals who at the beginning of such
period constitute the Board, and any new director (other than a director designated by a person who
has entered into an agreement with the Company to effect a transaction described in paragraph (a),
(c), or (d) of this Section) whose election by the Board or nomination for election by the
Companys shareholders was approved by a vote of at least two-thirds of the directors then still in
office who either were directors at the beginning of the two-year period or whose election or
nomination for election was previously so approved, cease for any reason to constitute at least a
majority of the Board;
(c) a merger, consolidation, reorganization, or other business combination of the Company with
any other entity, other than a merger or consolidation which would result in the voting securities
of the Company outstanding immediately prior thereto continuing to represent (either by remaining
outstanding or by being converted into voting securities of the
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surviving entity) more than fifty percent (50%) of the combined voting power of the voting
securities of the Company or such surviving entity outstanding immediately after such merger or
consolidation; provided, however, that a merger or consolidation effected to implement a
recapitalization of the Company (or similar transaction) in which no person acquires more than
twenty-five percent (25%) of the combined voting power of the Companys then outstanding securities
shall not constitute a Change in Control; or
(d) the shareholders of the Company approve a plan of complete liquidation of the Company or
the consummation of the sale or disposition by the Company of all or substantially all of the
Companys assets other than (x) the sale or disposition of all or substantially all of the assets
of the Company to a person or persons who beneficially own, directly or indirectly, at least fifty
percent (50%) or more of the combined voting power of the outstanding voting securities of the
Company at the time of the sale or (y) pursuant to a spin-off type transaction, directly or
indirectly, of such assets to the shareholders of the Company.
However, to the extent that Section 409A of the Code would cause an adverse tax consequence to
a Participant using the above definition, the term Change in Control shall have the meaning
ascribed to the phrase Change in the Ownership or Effective Control of a Corporation or in the
Ownership of a Substantial Portion of the Assets of a Corporation under Treasury Department
Proposed Regulation 1.409A-3(g)(5), as revised from time to time in either subsequent proposed or
final regulations, and in the event that such regulations are withdrawn or such phrase (or a
substantially similar phrase) ceases to be defined, as determined by the Committee.
Change in Control Price means the price per share of Common Stock paid in any transaction
related to a Change in Control of the Company.
Code means the Internal Revenue Code of 1986, as amended, and the regulations promulgated
thereunder.
Committee means a committee or sub-committee of the Board consisting of two or more members
of the Board, none of whom shall be an officer or other salaried employee of the Company, and each
of whom shall qualify in all respects as a non-employee director as defined in Rule 16b-3 under
the Exchange Act, and as an outside director for purposes of Code Section 162(m). If no
Committee exists, the functions of the Committee will be exercised by the Board; provided, however,
that a Committee shall be created prior to the grant of Awards to a Covered Employee and that
grants of Awards to a Covered Employee shall be made only by such Committee. Notwithstanding the
foregoing, with respect to the grant of Awards to non-employee directors, the Committee shall be
the Board.
Common Stock means the common stock, par value $0.01 per share, of the Company.
Company means Catalyst Pharmaceutical Partners, Inc., a Florida corporation, the
subsidiaries of Catalyst Pharmaceutical Partners, Inc. and all other entities whose financial
statements are required to be consolidated with the financial statements of Catalyst Pharmaceutical
Partners, Inc. pursuant to United States generally accepted accounting principles, and any other
entity determined to be an affiliate of Catalyst Pharmaceutical Partners, Inc. as determined by the
Committee in its sole and absolute discretion.
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Covered Employee means covered employee as defined in Code Section 162(m)(3).
Covered Individual means any current or former member of the Committee, any current or
former officer or director of the Company, or any individual designated pursuant to Section 4(c).
Detrimental Activity means any of the following: (i) the disclosure to anyone outside the
Company, or the use in other than the Companys business, without written authorization from the
Company, of any confidential information or proprietary information, relating to the business of
the Company, acquired by a Participant prior to a termination of the Participants employment or
service with the Company; (ii) activity while employed or providing services that is classified by
the Company as a basis for a termination for Cause; (iii) the Participants Disparagement, or
inducement of others to do so, of the Company or its past or present officers, directors, employees
or services; or (iv) any other conduct or act determined by the Committee, in its sole discretion,
to be injurious, detrimental or prejudicial to the interests of the Company. For purposes of
subparagraph (i) above, the Chief Executive Officer of the Company shall have authority to provide
the Participant with written authorization to engage in the activities contemplated thereby and no
other person shall have authority to provide the Participant with such authorization.
Disability means a permanent and total disability within the meaning of Code Section
22(e)(3); provided, however, that if a Participant and the Company have entered into an employment
or consulting agreement which defines the term Disability for purposes of such agreement,
Disability shall be defined pursuant to the definition in such agreement with respect to any Award
granted to the Participant on or after the effective date of the respective employment or
consulting agreement. The Committee shall determine in its sole and absolute discretion whether a
Disability exists for purposes of the Plan.
Disparagement means making any comments or statements to the press, the Companys employees,
clients or any other individuals or entities with whom the Company has a business relationship,
which could adversely affect in any manner: (i) the conduct of the business of the Company
(including, without limitation, any products or business plans or prospects), or (ii) the business
reputation of the Company or any of its products, or its past or present officers, directors or
employees.
Dividend Equivalents means an amount equal to the cash dividends paid by the Company upon
one share of Common Stock subject to an Award granted to a Participant under the Plan.
Effective Date shall mean the date that the Plan was approved by the shareholders of the
Company in accordance with the laws of the State of Florida or such later date as provided in the
resolutions adopting the Plan.
Eligible Individual means any employee, officer, director (employee or non-employee
director) or consultant of the Company and any Prospective Employee to whom Awards are granted in
connection with an offer of future employment with the Company.
Exchange Act means the Securities Exchange Act of 1934, as amended.
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Exercise Price means the purchase price per share of each share of Common Stock subject to
an Award.
Fair Market Value means, unless otherwise required by the Code, as of any date, the last
sales price reported for the Common Stock on the day immediately prior to such date (i) as reported
by the national securities exchange in the United States on which it is then traded, or (ii) if not
traded on any such national securities exchange, as quoted on an automated quotation system
sponsored by the National Association of Securities Dealers, Inc., or if the Common Stock shall not
have been reported or quoted on such date, on the first day prior thereto on which the Common Stock
was reported or quoted; provided, however, that the Committee may modify the definition of Fair
Market Value to reflect any changes in the trading practices of any exchange or automated system
sponsored by the National Association of Securities Dealers, Inc. on which the Common Stock is
listed or traded. If the Common Stock is not readily traded on a national securities exchange or
any system sponsored by the National Association of Securities Dealers, Inc., the Fair Market Value
shall be determined in good faith by the Committee.
The Company means Catalyst Pharmaceutical Partners, Inc., a Florida corporation.
Grant Date means the date on which the Committee approves the grant of an Award or such
later date as is specified by the Committee and set forth in the applicable Award Agreement.
Incentive Stock Option means an incentive stock option within the meaning of Code Section
422.
Non-Employee Director means a director of the Company who is not an active employee of the
Company.
Non-Qualified Stock Option means an Option which is not an Incentive Stock Option.
Option means an option to purchase Common Stock granted pursuant to Sections 6 of the Plan.
Participant means any Eligible Individual who holds an Award under the Plan and any of such
individuals successors or permitted assigns.
Performance Goals means the specified performance goals which have been established by the
Committee in connection with an Award.
Performance Period means the period during which Performance Goals must be achieved in
connection with an Award granted under the Plan.
Performance Share means a right to receive a fixed number of shares of Common Stock, or the
cash equivalent, which is contingent on the achievement of certain Performance Goals during a
Performance Period.
Performance Unit means a right to receive a designated dollar value, or shares of Common
Stock of the equivalent value, which is contingent on the achievement of Performance Goals during a
Performance Period.
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Person shall mean any person, corporation, partnership, joint venture or other entity or any
group (as such term is defined for purposes of Section 13(d) of the Exchange Act), other than a
Parent or Subsidiary.
Plan means this Catalyst Pharmaceutical Partners, Inc. 2006 Stock Incentive Plan.
Prospective Employee means any individual who has committed to become an employee of the
Company within sixty (60) days from the date an Award is granted to such individual.
Restricted Stock means Common Stock subject to certain restrictions, as determined by the
Committee, and granted pursuant to Section 8 hereunder.
Section 424 Employee means an employee of the Company or any subsidiary corporation or
parent corporation as such terms are defined in and in accordance with Code Section 424. The
term Section 424 Employee also includes employees of a corporation issuing or assuming any
Options in a transaction to which Code Section 424(a) applies.
Stock Appreciation Right means the right to receive all or some portion of the increase in
value of a fixed number of shares of Common Stock granted pursuant to Section 7 hereunder.
Transfer means, as a noun, any direct or indirect, voluntary or involuntary, exchange, sale,
bequeath, pledge, mortgage, hypothecation, encumbrance, distribution, transfer, gift, assignment or
other disposition or attempted disposition of, and, as a verb, directly or indirectly, voluntarily
or involuntarily, to exchange, sell, bequeath, pledge, mortgage, hypothecate, encumber, distribute,
transfer, give, assign or in any other manner whatsoever dispose or attempt to dispose of.
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EXHIBIT 23.1 CONSENT OF GRANT THORNTON LLP
Exhibit 23.1
CONSENT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM
We have issued our report dated July 24, 2006, accompanying the financial statements of Catalyst
Pharmaceutical Partners, Inc. (a Development Stage Company) contained in the Registration Statement
and Prospectus. We consent to the use of the aforementioned report in the Registration Statement
and Prospectus, and to the use of our name as it appears under the caption Experts.
/s/ Grant
Thornton LLP
Miami, Florida
July 24, 2006