Exhibit
10.1
NEUROGEN
CORPORATION
(a Delaware
Corporation)
6,993,000 Shares of Common
Stock
(Par Value $0.025 Per
Share)
PLACEMENT AGENCY
AGREEMENT
December 18, 2006
Pacific Growth
Equities, LLC
CIBC World
Markets Corp.
Leerink Swann
& Company
Merriman Curhan
Ford & Co.
c/o Pacific
Growth Equities, LLC
One Bush
Street, Suite 1700
Neurogen
Corporation, a Delaware corporation (the “Company”),
proposes, subject to the terms and conditions contained herein, to
issue and sell 6,993,000 shares of common stock, par value $0.025
per share, of the Company (the “Securities”) directly
to certain investors (collectively, the
“Investors”).
The Company desires to engage Pacific Growth
Equities, LLC (“PGE”), CIBC World Markets Corp.
(“CIBC”), Leerink Swann & Company
(“Leerink”) and Merriman Curhan Ford & Co.
(“Merriman”) as its placement agents (each, a
“Placement Agent” and, collectively, the
“Placement Agents”), for whom PGE is acting as
representative (in such capacity, the
“Representative”), in connection with the issuance and
sale of the Securities and hereby confirms its agreement with
respect to the placement of the Securities.
The Company has prepared and filed in conformity
with the requirements of the Securities Act of 1933, as amended
(the “Act”), and the published rules and regulations
thereunder (the “Rules and Regulations”) adopted by the
Securities and Exchange Commission (the “Commission”) a
Registration Statement (as hereinafter defined) on Form S-3,
initially filed on August 16, 2002, as amended (No. 333-98237),
relating to the Securities and the offering thereof from time to
time in accordance with Rule 415 of the Rules and Regulations, and
such amendments thereof as may have been required. The Registration
Statement includes a prospectus dated February 13, 2003 (the
“Base Prospectus”). The Company has filed the Base
Prospectus with the Commission and has filed with, or transmitted
for filing to, or shall promptly hereafter file with or transmit
for filing to the Commission, a prospectus supplement relating to
the Securities in accordance with Rule 424(b) under the Act (the
“Final Prospectus Supplement”). The term
“Registration Statement” as used in this Agreement
means the initial registration statement (including all exhibits,
financial schedules and all documents and information deemed to be
a part of the Registration Statement (through incorporation by
reference or otherwise)), as amended, at the time and on the date
it became effective (the “Effective Date”), including
the information (if any) contained in the form of final prospectus
filed with the Commission pursuant to Rule 424(b) of the Rules and
Regulations and deemed to be part thereof at the time of
effectiveness pursuant to Rule 430A of the Rules and Regulations.
The term “Prospectus” as used in this Agreement means
the Base Prospectus together with the Final Prospectus Supplement.
As used herein, the terms “Base Prospectus,”
“Prospectus,” “Registration Statement,” and
“Final Prospectus Supplement” shall include any
documents incorporated by reference therein and any reference to
any amendment or supplement to the Registration Statement or the
Prospectus shall be deemed to refer to and include any document
filed under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), after the date of the Base Prospectus
by the Company with the Commission and on or before the Closing
Date (as defined herein), that is deemed to be incorporated by
reference in the Registration Statement or the Prospectus. The
Company hereby confirms that each of the Placement Agents, in
connection with its duties in such capacity, is authorized to
distribute or cause to be distributed the Prospectus (as from time
to time amended or supplemented if the Company furnishes amendments
or supplements thereto to such Placement Agent).
All references in this Agreement to financial
statements and schedules and other information which is
“contained,” “included” or
“stated” in the Registration Statement or the
Prospectus (or other references of like import) shall be deemed to
mean and include all such financial statements and schedules and
other information which is incorporated by reference in the
Registration Statement or the Prospectus, as the case may be; and
all references in this Agreement to amendments or supplements to
the Registration Statement or the Prospectus shall be deemed to
mean and include the filing of any document under the Exchange Act
on or before the Closing Date (as defined herein), which is
incorporated by reference in the Registration Statement or the
Prospectus, as the case may be.
SECTION 1.
Agreement to A
ct as Placement Agents; Delivery and
Payment.
On the basis of
the representations, warranties and agreements contained in, and
subject to the terms and conditions of, this Agreement:
(a) Each Placement Agent agrees to act, on a
reasonable efforts basis, as the Company’s placement agent in
connection with the issuance and sale by the Company of the
Securities to the Investors. The Placement Agents shall have no
authority to bind the Company. The Company acknowledges and agrees
that each Placement Agent’s engagement hereunder is not an
agreement by such Placement Agent or any of its affiliates to
underwrite or purchase any securities or otherwise provide any
financing.
(b) Concurrently with the execution and delivery of
this Agreement, the Company, the Placement Agents, and American
Stock Transfer & Trust Company, as escrow agent (the
“Escrow Agent”), shall enter into an Escrow Agreement
substantially in the form of Exhibit A attached hereto (the
“Escrow Agreement”), pursuant to which an escrow
account will be established, at the Company’s expense, for
the benefit of the Company and the Investors (the “Escrow
Account”). Concurrently with the execution of the Purchase
Agreements (as defined below), (i) each of the Investors will
deposit in the Escrow Account an amount equal to $5.72 per share
multiplied by the number of Securities to be purchased by such
Investor, and (ii) the Escrow Agent will notify the Company and the
Placement Agents in writing of the amount of funds deposited in the
Escrow Account. As compensation for their services hereunder, the
Company agrees to pay the Placement Agents, on the Closing Date (as
defined herein), a commission of six percent (6%) of the gross
proceeds received by the Company from the sale of the Securities,
thirty-four percent (34%) of which will be paid to PGE, thirty
percent (30%) of which will be paid to CIBC, thirty percent (30%)
of which will be paid to Leerink, and six percent (6%) of which
will be paid to Merriman (regardless of the actual amount of
Securities placed by each Placement Agent);notwithstanding the
foregoing, the Placement Agents and the Company agree that
commissions on sales of Securities to investors identified in
Schedule A will be limited to one and one half percent
(1.5%) of gross proceeds raised from such investors. In addition,
the Company agrees to pay PGE a fee of $75,000 for capital markets
expenses.
(c) At 9:00 a.m., New York City time, on December
21, 2006, or at such other time and date as the Representative and
the Company determine pursuant to Rule 15c6-1(a) under the Exchange
Act (such time and date of delivery being herein referred to as the
“Closing Date”), and upon satisfaction of the
conditions set forth in this Agreement and the Purchase Agreements,
the Company shall deliver the Securities, which shall be registered
in name or names and shall be in such denominations as the
Placement Agents may request at least one business day before the
Closing Date, to the Investors, which delivery may be made through
the facilities of the Depository Trust Company, and the Escrow
Agent will disburse the funds from the Escrow Account to the
Company and the Placement Agents, by wire in federal (same day)
funds, as provided in the Escrow Agreement. The closing of the sale
of the Securities to the Investors (the “Closing”)
shall take place at the offices of Latham & Watkins LLP, 885
Third Avenue, Suite 1000, New York, New York 10022. All actions
taken at the Closing shall be deemed to have occurred
simultaneously.
(d) The several purchases of the Securities by the
Investors shall be evidenced by the execution of one or more
purchase agreements substantially in the form attached hereto as
Exhibit B (the “Purchase
Agreements”).
(e) Prior to the earlier of (i) the date on which
this Agreement is terminated and (ii) the Closing Date, the Company
shall not, without the prior consent of the Representative, solicit
or accept offers to purchase shares of its Common Stock (other than
pursuant to the exercise of stock options and warrants to purchase
Common Stock outstanding on the date hereof), otherwise than
through the Placement Agents.
SECTION 2.
Representations and
Warranties.
(a)
Representations and Warranties
by the Company . The
Company represents and warrants to each Placement Agent as of the
date hereof, and as of the Closing Date referred to in Section 1(c)
hereof, and agrees with each Placement Agent, as
follows:
(i)
Registration Statement,
Prospectus and Disclosure at Time of Sale . The Company meets the requirements for use of
Form S-3 under the Act and has complied with the requirements of
Rule 415 with respect to the Registration Statement. Each of the
Registration Statement and any post-effective amendment thereto has
become effective under the Act and no stop order preventing or
suspending the use of the Prospectus or suspending the
effectiveness of the Registration Statement has been issued under
the Act and no proceedings for that purpose have been instituted or
are pending or, to the knowledge of the Company, are contemplated
by the Commission, and any request received by the Company on the
part of the Commission for additional information has been complied
with.
On the
Effective Date and on the Closing Date, the Registration Statement
complied in all material respects, and on the date of the
Prospectus, the date any Prospectus Supplement or amendment to the
Prospectus is filed with the Commission and the Closing Date, the
Prospectus will comply, in all material respects, with the
requirements of the Act and the Rules and Regulations and the
Exchange Act and the published rules and regulations of the
Commission thereunder. The Registration Statement, as of the
Effective Date, contained no untrue statement of a material fact or
omitted to state a material fact required to be stated therein or
necessary in order
to make the
statements therein not misleading. As of the Applicable Time and at
the Closing Date, neither (x) any Issuer-Represented General Free
Writing Prospectus(es) (as defined below) issued at or prior to the
Applicable Time (as defined below), the Base Prospectus and the
information included on Exhibit E hereto, all considered
together (collectively, the “General Disclosure
Package”), nor (y) any individual Issuer-Represented Limited
Use Free Writing Prospectus, when considered together with the
General Disclosure Package, contained an untrue statement of a
material fact or omitted to state a material fact required to be
stated therein or necessary in order to make the statements
therein, in the light of the circumstances under which they were
made, not misleading. On the date of the filing of the Prospectus
with the Commission, the first delivery of the Prospectus to the
Investors, the date hereof, and the Closing Date, neither the
Prospectus nor any amendment thereof or supplement thereto,
contained or will contain any untrue statement of a material fact
or omitted or will omit to state any material fact required to be
stated therein or necessary in order to make the statements
therein, in light of the circumstances under which they were made,
not misleading. Notwithstanding the foregoing, none of the
representations and warranties in this Section 2(a)(i) shall apply
to statements in, or omissions from, the Registration Statement or
the Prospectus made in reliance upon, and in conformity with,
information furnished in writing to the Company by any Placement
Agent through the Representative expressly for use in the
Registration Statement or the Prospectus.
The Prospectus
delivered to the Placement Agents for use in connection with this
offering was identical to the electronically transmitted copies
thereof filed with the Commission pursuant to EDGAR, except to the
extent permitted by Regulation S-T. The Company has not distributed
any offering material in connection with the offering and sale of
the Securities, other than the Registration Statement, the
Prospectus and the General Disclosure Package.
As used in this
subsection and elsewhere in this Agreement:
“Applicable Time” means 9:00 a.m.
(New York City time) on December 19, 2006.
“Issuer-Represented Free Writing
Prospectus” means any “issuer free writing
prospectus,” as defined in Rule 433 of the Rules and
Regulations (“Rule 433”), relating to the Securities
that (i) is required to be filed with the Commission by the Company
or (ii) is a “road show that is a written
communication” within the meaning of Rule 433(d)(8)(i),
whether or not required to be filed with the Commission or is
exempt from filing pursuant to Rule 433(d)(5)(i) because it
contains a description of the Securities or of the offering that
does not reflect the final terms, in each case in the form filed or
required to be filed with the Commission or, if not required to be
filed, in the form retained in the Company’s records pursuant
to Rule 433(g).
“Issuer-Represented General Free Writing
Prospectus” means any Issuer-Represented Free Writing
Prospectus that is intended for general distribution to prospective
investors, as evidenced by its being specified in Schedule C
hereto .
“Issuer-Represented Limited Use Free
Writing Prospectus” means any Issuer-Represented Free Writing
Prospectus that is not an Issuer-Represented General Free Writing
Prospectus.
Each
Issuer-Represented Free Writing Prospectus, as of its issue date
and at all subsequent times through the Closing Date or until any
earlier date that the issuer notified or notifies the
Representative, did not, does not and will not include any
information that conflicted, conflicts or will conflict with the
information contained in the Registration Statement or the
Prospectus, including any document incorporated by reference
therein and any preliminary or other prospectus deemed to be a part
thereof that has not been superseded or modified.
The documents
incorporated by reference in the Registration Statement and the
Prospectus, at the time they became effective or were filed with
the Commission, as the case may be, complied in all material
respects with the requirements of the Act or the Exchange Act, as
applicable, and the rules and regulations of the Commission
thereunder, and at the time they became effective or were filed
with the Commission, as the case may be, none of such documents
contained an untrue statement of a material fact or omitted to
state a material fact required to be stated therein or necessary in
order to make the statements therein, in the light of the
circumstances under which they were made, not misleading, and any
further documents so filed and incorporated by reference in the
Registration Statement and the Prospectus, when such documents
become effective or are filed with the Commission, as the case may
be, will conform in all material respects to the requirements of
the Act or the Exchange Act, as applicable, and the rules and
regulations of the Commission thereunder and will not contain an
untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary to make the
statements therein, in light of the circumstances under which they
are made, not misleading. Notwithstanding anything to the contrary
contained in this subsection, the representations and warranties
contained in this subsection do not apply to statements or
omissions made in reliance upon and in conformity with information
furnished in writing to the Company by any Placement Agent or any
of its agents or representatives through the Representative
expressly for use in the Registration Statement, the Prospectus or
any amendment or supplement thereto.
(ii)
Independent
Accountants .
PricewaterhouseCoopers LLP, which certified the financial
statements and supporting schedules included in the Registration
Statement or incorporated by reference in the Registration
Statement or the Prospectus, is an independent public accountant as
required by the Act and the Rules and Regulations.
(iii)
Financial Statements
. The financial statements of the
Company included or incorporated by reference in the Registration
Statement, the General Disclosure Package and the Prospectus,
together with the related schedules and notes, present fairly the
financial position of the Company and its consolidated subsidiaries
at the dates indicated and the statement of
operations, stockholders’ equity and cash flows of the
Company and its consolidated subsidiaries for the periods
specified; said financial statements have been prepared in
conformity with generally accepted accounting principles
(“GAAP”) applied on a consistent basis throughout the
periods involved. The supporting schedules included in the
Registration Statement present fairly in accordance with GAAP the
information required to be stated therein, unless otherwise noted
therein. The selected financial data and the summary financial
information included or incorporated by reference in the Prospectus
present fairly the information shown therein and have been compiled
on a basis consistent with that of the audited financial statements
included or incorporated by reference in the Registration
Statement. No other financial statements or schedules are required
to be included in the Registration Statement or Prospectus. Any
disclosures contained in the Registration Statement, the General
Disclosure Package or the Prospectus regarding “non-GAAP
financial measures” (as such term is defined by the rules and
regulations of the Commission) comply with Regulation G of the
Exchange Act and Item 10 of Regulation S-K under the Act, to the
extent applicable. Except as described in the Prospectus or
Registration Statement, there are no material off-balance sheet
transactions, arrangements, obligations (including contingent
obligations), or any other relationships with unconsolidated
entities or other persons, that may have a material effect on the
Company’s financial condition, changes in financial
condition, results of operations, liquidity, capital expenditures,
capital resources or significant components of revenue or expenses.
No Material Adverse Change in Business . Since the
respective dates as of which information is given in the
Registration Statement, the General Disclosure Package and the
Prospectus, except as otherwise stated therein, (A) there has
been no material adverse change, or any development that would be
reasonably expected to result in a material adverse change, in the
condition, financial or otherwise, or in the earnings or business
affairs of the Company and its subsidiaries taken as a whole,
whether or not arising in the ordinary course of business (a
“Material Adverse Effect”), (B) there have been no
transactions entered into by the Company or any of its
subsidiaries, other than those in the ordinary course of business,
which are material with respect to the Company and its subsidiaries
taken as a whole, and (C) there has been no dividend or
distribution of any kind declared, paid or made by the Company on
any class of its capital stock.
(iv)
Good Standing of the
Company . The Company has
been duly organized and is validly existing as a corporation in
good standing under the laws of the State of Delaware and has full
corporate power and authority to own, lease and operate its
properties and to conduct its business as described in the
Prospectus and the General Disclosure Package and to enter into and
perform its obligations under this Agreement, the Escrow Agreement,
and the Purchase Agreements; and the Company is duly qualified as a
foreign corporation to transact business and is in good standing in
each other jurisdiction in which such qualification is required,
whether by reason of the ownership or leasing of property or the
conduct of business, except where the failure so to qualify or to
be in good standing would not reasonably be expected to result in a
Material Adverse Effect.
(v)
Good Standing of
Subsidiary . Neurogen
Properties, LLC (the “Subsidiary”) has been duly formed
and is validly existing as a limited liability company in good
standing under the laws of the jurisdiction of its formation, has
limited liability company power and authority to own, lease and
operate its properties and to conduct its business as described in
the Prospectus and the General Disclosure Package, and is duly
qualified as a foreign limited liability company to transact
business and is in good standing in each jurisdiction in which such
qualification is required, whether by reason of the ownership or
leasing of property or the conduct of business, except where the
failure so to qualify or to be in good standing would not
reasonably be expected to result in a Material Adverse Effect;
except as otherwise disclosed in the Registration Statement, the
General Disclosure Package and the Prospectus, all of the issued
and outstanding membership interests of the Subsidiary have been
duly authorized and validly issued, is fully paid and
non-assessable and is owned by the Company, directly or through
subsidiaries, free and clear of any security interest, mortgage,
pledge, lien, encumbrance, claim or equity; none of the outstanding
membership interests of the Subsidiary were issued in violation of
the preemptive or similar rights of any securityholder of the
Subsidiary. The only subsidiary of the Company is the subsidiary
listed on Exhibit 21.1 to the Company’s Annual Report on Form
10-K for the year ended December 31, 2005.
(vi)
Capitalization
. The authorized capital stock of
the Company consists of 50,000,000 shares of common stock, par
value $0.025 per share (the “Common Stock”), and
2,000,000 shares of preferred stock, par value $0.025 per share
(the “Preferred Stock”). After giving effect to the
transactions contemplated by this Agreement, as of the date
hereof:
(A) The issued and outstanding capital stock of the
Company will consist of 41,773,465 shares of Common Stock and zero
(0) shares of Preferred Stock; and
(B) The Company will have (x) an aggregate of
5,276,367 shares of Common Stock reserved for issuance upon the
exercise of outstanding options granted under the Company’s
outstanding option plans and employee stock purchase programs
(collectively, the “Option Plans”), (y) zero (0) shares
of Common Stock reserved for issuance upon the exercise of
outstanding warrants, and (z) zero (0) shares of Common Stock
reserved for issuance upon conversion of its convertible
indebtedness.
All of the shares of issued and outstanding
capital stock of the Company have been duly authorized and validly
issued and are fully paid and non-assessable; none of the
outstanding shares of capital stock of the Company was issued in
violation of the preemptive or other similar rights of any
securityholder of the Company.
(vii)
Authorization of
Agreement . The Company
has full corporate power and authority to (a) enter into this
Agreement, the Escrow Agreement and the Purchase Agreements and to
consummate the transactions contemplated hereby and thereby, and
(b) authorize, execute, issue, and deliver the Securities as
contemplated by this Agreement, the Escrow Agreement and the
Purchase Agreements. This Agreement, the Escrow Agreement,
and the Purchase Agreements have been duly
authorized, executed and delivered by the Company, and constitute
legal and binding obligations of the Company, enforceable in
accordance with their terms, except to the extent that rights to
indemnity hereunder may be limited by federal or state securities
laws and except as such enforceability may be limited by
bankruptcy, fraudulent conveyance, insolvency, reorganization or
similar laws affecting the rights of creditors generally and
subject to general principles of equity.
(viii)
Authorization and Description of
Securities . The
Securities to be purchased by the Investors from the Company have
been duly authorized for issuance and sale to the Investors
pursuant to this Agreement and, when issued and delivered by the
Company pursuant to this Agreement against payment of the
consideration set forth in the Purchase Agreements, will be validly
issued and fully paid and non-assessable; the Common Stock conforms
in all material respects to all statements relating thereto
contained in the Prospectus and the General Disclosure Package and
such description conforms in all material respects to the rights
set forth in the instruments defining the same; no holder of the
Securities will be subject to personal liability by reason of being
such a holder; and the issuance of the Securities is not subject to
the preemptive or other similar rights of any securityholder of the
Company, with the exception of any such rights which have been
waived by the holder thereof.
(ix)
Absence of Defaults and
Conflicts . Neither the
Company nor any of its subsidiaries is (A) in violation of its
charter or by-laws, or (B) except for such defaults that would not,
individually or in the aggregate, reasonably be expected to result
in a Material Adverse Effect, in default in the performance or
observance of any obligation, agreement, covenant or condition
contained in any material contract, indenture, mortgage, deed of
trust, loan or credit agreement, note, lease or other agreement or
instrument to which the Company or any of its subsidiaries is a
party or by which it or any of them may be bound, or to which any
of the property or assets of the Company or any subsidiary is
subject (collectively, “Agreements and Instruments”)
and the execution, delivery and performance of this Agreement and
the consummation of the transactions contemplated herein and in the
Registration Statement, the General Disclosure Package and the
Prospectus (including the issuance and sale of the Securities and
the use of the proceeds from the sale of the Securities as
described in the Prospectus under the caption “Use of
Proceeds”) and compliance by the Company with its obligations
hereunder, have been duly authorized by all necessary corporate
action and do not and will not, whether with or without the giving
of notice or passage of time or both, conflict with or constitute a
breach of,or default or Repayment Event (as defined below) under,
or result in the creation or imposition of any lien, charge or
encumbrance upon any property or assets of the Company or any
subsidiary pursuant to, the Agreements and Instruments (except for
such conflicts, breaches, defaults or Repayment Events or liens,
charges or encumbrances that would not be reasonably likely to
result in a Material Adverse Effect), nor will such action result
in (C) any violation of the provisions of the charter or by-laws of
the Company or any subsidiary or (D) except for such violations
that would not, individually or in the aggregate, reasonably be
expected to result in a Material Adverse Effect, a violation of any
applicable law, statute, rule, regulation, judgment, order, writ or
decree of any government, government instrumentality or court,
domestic or foreign, having jurisdiction over the Company or any
subsidiary or any of their assets, properties or operations. As
used herein, a “Repayment Event” means any event or
condition which gives the holder of any note, debenture or other
evidence of indebtedness (or any person acting on such
holder’s behalf) the right to require the repurchase,
redemption or repayment of all or a portion of such indebtedness by
the Company or any subsidiary of the Company.
(x)
Absence of Labor
Dispute . No material
labor dispute with the employees of the Company or any subsidiary
exists or, to the knowledge of the Company, is imminent, and the
Company is not aware of any existing or imminent labor disturbance
by the employees of any of its or any of its subsidiaries’
principal suppliers, manufacturers, customers or contractors,
which, in either case, would result in a Material Adverse
Effect.
(xi)
Absence of Proceedings
. There is no claim, action, suit,
proceeding, inquiry, audit, review or investigation before or
brought by any court or governmental agency or body, domestic or
foreign, now pending, or, to the knowledge of the Company,
threatened against the Company or any subsidiary of the Company,
or, to the knowledge of the Company, otherwise involving the
Company or any subsidiary of the Company which is required to be
disclosed in the Registration Statement (other than as disclosed
therein), or which would be reasonably likely to result in a
Material Adverse Effect, or which would be reasonably likely to
materially and adversely affect the consummation of the
transactions contemplated in this Agreement or the performance by
the Company of its obligations hereunder; the aggregate of all
pending legal or governmental proceedings to which the Company or
any subsidiary is a party or of which any of their respective
property or assets is the subject which are not described in the
Registration Statement, including ordinary routine litigation
incidental to the Company’s conduct of its business, would
not be reasonably likely to result in a Material Adverse
Effect.
(xii)
Absence of Rulemaking or Similar
Proceedings . To the
Company’s knowledge, there are no rulemaking or similar
proceedings before the Food and Drug Administration, the Department
of Health and Human Services, the Centers for Medicare and Medicaid
Services or any other federal, state, local or foreign governmental
bodies that regulate the Company’s or any of its
subsidiaries’ activities, which would reasonably be expected
to have a Material Adverse Effect.
(xiii)
Accuracy of Descriptions and
Exhibits . There are no
statutes, regulations, contracts or documents which are required to
be described in the Registration Statement or the Prospectus or to
be filed as exhibits thereto which have not been so described and
filed as required.
(xiv)
Possession of Intellectual
Property .
The Company and its subsidiaries own or license or have rights
to use, make, sell, and otherwise exploit, all Intellectual
Property necessary for the conduct of the Company’s business
as now conducted except as such failure to own or license such
rights would not have a Material Adverse Effect. To the knowledge
of theCompany, there is no infringement, misappropriation or
violation by other parties of any Intellectual Property described
in the preceding sentence, except as such infringement,
misappropriation or violation would not reasonably be expected to
have a Material Adverse Effect. There is no pending, or, to the
knowledge of the Company, threatened action, suit, proceeding or
claim by others to which the Company or any of its subsidiaries is
a party, or to the knowledge of the Company, otherwise challenging
the Company’s or its subsidiaries’ rights in or to, or
exploitation of, any such Intellectual Property, and the Company
has no knowledge of any facts which would form a reasonable basis
for any such claim. The Intellectual Property owned by the Company
and, to the knowledge of the Company, the Intellectual Property
licensed to the Company have not been adjudged invalid or
unenforceable, in whole or in part, and there is no pending or, to
the knowledge of the Company, threatened action, suit, proceeding
or claim by others challenging the validity or scope of any
Intellectual Property, and the Company has no knowledge of any
facts which would form a reasonable basis for any such claim. There
is no pending or to the knowledge of the Company, threatened
action, suit, proceeding or claim by others that the Company
infringes, misappropriates or otherwise violates any Intellectual
Property or other proprietary rights of others, and the Company has
not received any written notice of such claim and has
no knowledge of any other fact which would
form a reasonable basis for any such claim. To the Company’s
knowledge, no employee or independent contractor of the Company is
in or has ever been in violation of any term of any employment
contract, patent disclosure agreement, invention assignment
agreement, non-competition agreement, non-solicitation agreement,
nondisclosure agreement or any restrictive covenant to or with a
former employer or independent contractor where the basis of such
violation relates to such employee’s employment or
independent contractor’s engagement with the Company or
actions undertaken while employed or engaged with the Company,
except as such violation would not reasonably be expected to have a
Material Adverse Effect. “Intellectual Property” shall
mean all patents, patent rights, patent applications, trade and
service marks, trade and service mark registrations, trade names,
copyrights, licenses, inventions, trade secrets, technology,
know-how and other unpatented and/or unpatentable proprietary or
confidential information, systems or procedures owned, licensed or
used by the Company.
(xv)
Absence of Further
Requirements . No filing
with, or authorization, approval, consent, license, order,
registration, qualification or decree of, any court or governmental
authority or agency is necessary or required for the performance by
the Company of its obligations hereunder, in connection with the
offering, issuance or sale of the Securities hereunder or the
consummation of the transactions contemplated by this Agreement,
except such as (i) have been already obtained or made, (ii) as may
be required under the Act or the Rules and Regulations or state
securities laws, or (iii) with respect to the listing of the
Securities on the Nasdaq Global Market which will be made prior to
the Closing.
(xvi)
Absence of
Manipulation . Neither
the Company nor, to the knowledge of the Company any affiliate of
the Company has taken, nor will the Company or, to the knowledge of
the Company, any affiliate take, directly or indirectly, any action
which is designed to or which has constituted or which would be
expected to cause or result in stabilization or manipulation of the
price of any security of the Company to facilitate the sale or
resale of the Securities.
(xvii)
Possession of Licenses and
Permits . The Company and
its subsidiaries possess such regulatory and quasi-regulatory
permits, licenses, approvals, consents and other authorizations
(collectively, “Governmental Licenses”) issued by the
appropriate federal, state, local or foreign regulatory agencies or
bodies necessary to conduct the business now operated by them,
except where the failure so to possess would not, singly or in the
aggregate, reasonably be expected to result in a Material Adverse
Effect; the Company and its subsidiaries are incompliance with the
terms and conditions of all such Governmental Licenses, except
where the failure so to comply would not, singly or in the
aggregate, reasonably be expected to result in a Material Adverse
Effect; all of the Governmental Licenses are valid and in full
force and effect, except when the invalidity of such Governmental
Licenses or the failure of such Governmental Licenses to be in full
force and effect would not, singly or in the aggregate, reasonably
be expected to result in a Material Adverse Effect; and neither the
Company nor any of its subsidiaries has received notice of any
proceedings relating to the revocation or modification of any such
Governmental Licenses which, singly or in the aggregate, if the
subject of an unfavorable decision, ruling or finding, would
reasonably be expected to result in a Material Adverse
Effect.
(xviii)
Regulatory Authorities
. Except as described in the
Prospectus, the General Disclosure Package and the Registration
Statement, each of the Company and its subsidiaries: (a) is and at
all times has been in material compliance with all statutes, rules
or regulations applicable to the ownership, testing, development,
manufacture, packaging, processing, use, distribution, marketing,
labeling, promotion, sale, offer for sale, storage, import, export
or disposal of any product manufactured or distributed by the
Company (“Applicable Laws”); (b) has not received any
FDA Form 483, notice of adverse finding, warning letter, untitled
letter or other correspondence or notice from the U.S. Food and
Drug Administration or any other federal, state or foreign
governmental authority having authority over the Company
(“Governmental Authority”) alleging or asserting
material noncompliance with any Applicable Laws or any licenses,
certificates, approvals, clearances, authorizations, permits and
supplements or amendments thereto required by any such Applicable
Laws (“Authorizations”); (c) possesses all
Authorizations (except as would not reasonably be expected to have
a Material Adverse Effect) and such Authorizations are valid and in
full force and effect and are not in material violation of any term
of any such Authorizations (except as would not reasonably be
expected to have a Material Adverse Effect); (d) has not received
notice of any claim, action, suit, proceeding, hearing,
enforcement, investigation, arbitration or other action from any
Governmental Authority or third party alleging that any product,
operation or activity is in violation of any Applicable Laws or
Authorizations and have no knowledge that any such Governmental
Authority or third party is considering any such claim, litigation,
arbitration, action, suit, investigation or proceeding; (e) has not
received notice that any Governmental Authority has taken, is
taking or intends to take action to limit, suspend, modify or
revoke any Authorizations and has no knowledge that any such
Governmental Authority is considering such action; and (f) has
filed, obtained, maintained or submitted all material reports,
documents, forms, notices, applications, records, claims,
submissions and supplements or amendments as required by any
Applicable Laws or Authorizations and that all such reports,
documents, forms, notices, applications, records, claims,
submissions and supplements or amendments were materially complete
and correct on the date filed (or were corrected or supplemented by
a subsequent submission).
The studies,
tests and preclinical and clinical trials conducted by or on behalf
of the Company and each of its subsidiaries were and, if still
pending, are being conducted in all material respects in accordance
with experimental protocols, procedures and controls pursuant to
accepted professional scientific standards and all Applicable Laws
and Authorizations, including, without limitation, the Federal
Food, Drug and Cosmetic Act and implementing regulations at 21
C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the
results of such studies, tests and trials contained in the
Prospectus, the General Disclosure Package and the Registration
Statement are accurate and complete in all material respects and
fairly present the data derived from such studies, tests and
trials; except to the extent disclosed in the Prospectus, the
General Disclosure Package and the Registration Statement, the
Company is not aware of any studies, tests or trials the results of
which the Company believes reasonably call into question the study,
test, or trial results described or referred to in the Prospectus,
the General Disclosure Package and the Registration Statement when
viewed in the context in which such results are described and the
clinical state of development; and neither the Company nor any of
its subsidiaries has received any notices or correspondence from
any Governmental Authority requiring the termination, suspension or
material modification of any studies, tests or preclinical or
clinical trials after they were initiated and which were conducted
by or on behalf of the Company or any of its
subsidiaries.
(xix)
Compliance with Health Care
Laws .
Neither the Company or any subsidiary, nor
their respective officers, directors, employees, agents and
contractors (exercising their respective duties on behalf of the
Company or any subsidiary), nor the Company’s or any
subsidiary’s business operations, is, or at any time has
been, in violation of any Health Care Laws, except where such
violation would not reasonably be expected to result in a Material
Adverse Effect. “Health Care Laws” shall mean (i) the
federal Food, Drug and Cosmetic Act (21 U.S.C. § 321 et seq.),
and the regulations promulgated thereunder, (ii) all federal and
state fraud and abuse laws, including, without limitation, the
federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the
Stark Law (42 U.S.C. § 1395nn), the Civil False Claims Act (31
U.S.C. § 3729 et seq.), the Administrative False Claims Law
(42 U.S.C. § 1320a-7b(a)), the Anti-Inducement Law (42 U.S.C.
§ 1320a-7a(a)(5)), Sections 1320a-7 and 1320a-7a of Title 42
of the United States Code and the regulations promulgated pursuant
to such statutes, (iii) the administrative simplification
provisions of the Health Insurance Portability and Accountability
Act of 1996 (42 U.S.C. §§ 1320d-1320d-8), the regulations
promulgated thereunder and comparable state laws, (iv) the
Controlled Substances Act (21 U.S.C. § 801 et seq.), (v)
Titles XVIII (42 U.S.C. § 1395 et seq.) and XIX (42 U.S.C.
§ 1396 et seq.) of the Social Security Act and the regulations
promulgated thereunder, (vi) quality, safety and accreditation
standards and requirements of all applicable foreign or state laws
or regulatory bodies, and (vii) any and all other applicable health
care laws, regulations, manual provisions, policies and
administrative guidance, each of (i) through (vii) as may be
amended from time to time.
(xx)
Title to Property
. The Company and its Subsidiary
have good and marketable title to all real property owned by the
Company and its Subsidiary and good title to all other properties
owned by them, in each case, free and clear of all mortgages,
pledges, liens, security interests, claims, restrictions or
encumbrances of any kind except such as (a) are described in the
Prospectus and the General Disclosure Package or (b) would not,
singly or in the aggregate, materially adversely affect the value
of such property, and do not interfere with the use made and
proposed to be made of such property by the Company or any of its
subsidiaries; and, except as described in the Prospectus, all of
the leases and subleases material to the business of the Company
and its subsidiaries, taken as a whole, and under which the Company
or any of its subsidiaries holds properties described in the
Prospectus and the General Disclosure Package, are in full force
and effect, and neither the Company nor any subsidiary has any
notice of any material claim of any sort that has been asserted by
anyone adverse to the rights of the Company or any subsidiary under
any of the leases or subleases mentioned above, or affecting or
questioning the rights of the Company or such subsidiary to the
continued possession of the leased or subleased premises under any
such lease or sublease.
(xxi)
Investment Company Act
. The Company is not required, and
upon the issuance and sale of the Securities as herein contemplated
and the application of the net proceeds therefrom as described in
the Prospectus and the General Disclosure Package will not be
required, to register as an “investment company” under
the Investment Company Act of 1940, as amended (the “1940
Act”).
(xxii)
Environmental Laws
. Except as described in the
Registration Statement, the General Disclosure Package and the
Prospectus and except as would not, singly or in the aggregate,
reasonably be expected to result in a Material Adverse Effect, (A)
neither the Company nor any of its subsidiaries is in violation of
any federal, state, local or foreign statute, law, rule,
regulation, ordinance, code, policy or rule of common law or any
judicial or administrative interpretation thereof, including any
judicial or administrative order, consent, decree or judgment,
relating to pollution or protection of human health, the
environment (including, without limitation, ambient air, surface
water, groundwater, land surface or subsurface strata) or wildlife,
including, without limitation, laws and regulations relating to the
release or threatened release of chemicals, pollutants,
contaminants, wastes, toxic substances, hazardous substances,
petroleum or petroleum products, asbestos-containing materials or
mold (collectively, “Hazardous Materials”) or to the
manufacture, processing, distribution, use, treatment, storage,
disposal, transport or handling of Hazardous Materials
(collectively, “Environmental Laws”), (B) the Company
and its subsidiaries have all permits, authorizations and approvals
required under any applicable Environmental Laws (except where the
absence of such permits, authorizations and approvals would not
reasonably be expected to have a Material Adverse Effect) and are
each in compliance with their requirements in all material
respects, (C) except as described in the Prospectus, there are no
pending or, to the knowledge of the Company, threatened
administrative, regulatory or judicial actions, suits, demands,
demand letters, claims, liens, notices of noncompliance or
violation, investigation or proceedings relating to any
Environmental Law against the Company or any of its subsidiaries
and (D) except as described in the Prospectus, and to the knowledge
of the Company, there are no events or circumstances that would
reasonably be expected to form the basis of an order for clean-up
or remediation, or an action, suit or proceeding by any private
party or governmental body or agency, against or affecting the
Company or any of its subsidiaries relating to Hazardous Materials
or any Environmental Laws.
(xxiii)
Registration Rights
. There are no persons with
registration rights or other similar rights to have any securities
registered pursuant to the Registration Statement or otherwise
registered by the Company under the Act, except under the
Securities Purchase Agreement by and between the Company and the
Investors listed on the signature pages thereto dated as of March
19, 2004, which rights have been waived.
(xxiv)
ERISA . Each employee benefit plan, within the meaning
of Section 3(3) of the Employee Retirement Income Security Act of
1974, as amended (“ERISA”), that is or has been
maintained, administered or contributed to by the Company or any
member of any group that includes or has
included the Company (as determined under Section 414(b), (c), (m),
or (o) of the Internal Revenue Code of 1986, as amended (the
“Code”)) (a “Company Affiliate”) for their
employees or former employees has been maintained in compliance in
all material respects with its terms and the requirements of any
applicable statutes, orders, rules and regulations, including but
not limited to ERISA and the Code to the knowledge of the Company;
no prohibited transaction, within the meaning of Section 406 of
ERISA or Section 4975 of the Code, has occurred with respect to any
such plan, excluding transactions effected pursuant to a statutory
or administrative exemption; and for each such plan that is subject
to the funding rules of Section 412 of the Code or Section 302 of
ERISA, there has not occurred any “accumulated funding
deficiency” within the meaning of Section 412 of the Code or
Section 302 of ERISA, respectively, whether or not waived, and the
fair market value of the assets of each such plan (excluding for
these purposes accrued but unpaid contributions) exceeds the
present value of all benefits accrued under such plan determined as
of the plan’s most recent actuarial report
using the actuarial assumptions set forth
therein, and such actuarial assumptions are reasonable in the
aggregate. Neither the Company nor any Company Affiliate has
incurred or is reasonably expected to incur any liability to any
“multiemployer plan” within the meaning of Section
3(37)or 4001(a)(3) of ERISA. Neither the Company nor any Company
Affiliate has incurred or is reasonably expected to incur any
liability under any “welfare plan” within the meaning
of Section 3(1) of ERISA that provides benefits to retired or
terminated employees (other than as required by Section 4980B of
the Code or Title I, Subtitle B, Part 6 of ERISA).
(xxv)
Accounting Controls
. The Company and its subsidiaries
maintain a system of internal accounting controls sufficient to
provide reasonable assurances that (i) transactions are
executed in accordance with management’s general or specific
authorization; (ii) transactions are recorded as necessary to
permit preparation of financial statements in conformity with
generally accepted accounting principles and to maintain
accountability for assets; (iii) access to assets is permitted
only in accordance with management’s general or specific
authorization; and (iv) the recorded value for assets is
compared with existing assets at reasonable interv
|