Exhibit 10.1
14,000,000 Shares of Common
Stock
and Warrants to Purchase up to
7,000,000 Shares of Common Stock
DISCOVERY LABORATORIES,
INC.
Common Stock (par value
$0.001)
PLACEMENT AGENT
AGREEMENT
May 8, 2009
LAZARD CAPITAL
MARKETS LLC
30 Rockefeller
Plaza
New York, New
York 10020
Dear
Sirs:
1. Introduction
. Discovery Laboratories,
Inc., a Delaware corporation (the “ Company ”),
proposes to issue and sell to the purchasers, pursuant to the terms
and conditions of this Placement Agent Agreement (this “
Agreement ”) and the Subscription Agreements in the
form of Exhibit A attached hereto (the “
Subscription Agreements ”) entered into with the
purchasers identified therein (each a “ Purchaser
” and, collectively, the “ Purchasers ”),
up to an aggregate of 14,000,000 units (the “ Units
”), with each Unit consisting of (i) one share of common
stock (a “ Share ” and, collectively, the
“ Shares ”), $0.001 par value per share (the
“ Common Stock ”) of the Company and (ii) one
warrant to purchase 0.50 of a share of Common Stock (the “
Warrants ”). Units will not be issued or
certificated. The Shares and Warrants are immediately
separable and will be issued separately. The terms and conditions
of the Warrants are set forth in the form of Exhibit B
attached hereto. The Shares issuable upon exercise of
the Warrants are referred to herein as the “ Warrant
Shares ” and, together with the Units, the Shares and the
Warrants, are referred to herein as the “ Securities
.” The Company hereby confirms that Lazard Capital
Markets LLC (“ LCM ” or the “ Placement
Agent ”) acted as the Placement Agent in accordance with
the terms and conditions hereof.
2.
Agreement to Act as Placement Agent; Placement of
Units . On the
basis of the representations, warranties and agreements of the
Company herein contained, and subject to all the terms and
conditions of this Agreement:
2.1 The Company has authorized and hereby
acknowledges that the Placement Agent has acted as its exclusive
agent to solicit offers for the purchase of all or part of the
Units from the Company in connection with the proposed offering of
the Units (the “ Offering ”). Until
the earlier of the termination of this Agreement or the Closing
Date (as defined in Section 4 hereof), the Company shall
not, without the prior written consent of the Placement Agent,
solicit or accept offers to purchase Units otherwise than through
the Placement Agent. LCM may utilize the expertise of
Lazard Frères & Co. LLC in connection with LCM’s
placement agent activities.
2.2 The Company hereby acknowledges that the
Placement Agent, as agent of the Company, used its reasonable best
efforts to solicit offers to purchase the Units from the Company on
the terms and subject to the conditions set forth in the Prospectus
(as defined below). The Placement Agent shall use commercially
reasonable efforts to assist the Company in obtaining performance
by each Purchaser whose offer to purchase Units was solicited by
the Placement Agent and accepted by the Company, but the Placement
Agent shall not, except as otherwise provided in this Agreement, be
obligated to disclose the identity of any potential purchaser or
have any liability to the Company in the event any such purchase is
not consummated for any reason. Under no circumstances will the
Placement Agent be obligated to underwrite or purchase any Units
for its own account and, in soliciting purchases of Units, the
Placement Agent acted solely as the Company’s agent and not
as principal. Notwithstanding the foregoing and except
as otherwise provided in Section 2.3 , it is understood and
agreed that the Placement Agent (or its affiliates) may, solely at
its discretion and without any obligation to do so, purchase Units
from the Company as principal and any such purchases by the
Placement Agent (or its affiliates) shall be disclosed to the
Company (including the identity of such purchaser).
2.3 Subject to the provisions of this Section
2 , offers for the purchase of Units were solicited by the
Placement Agent as agent for the Company at such times and in such
amounts as the Placement Agent deemed advisable. The
Placement Agent communicated to the Company, orally or in writing,
each reasonable offer to purchase Units received by it as agent of
the Company. The Company shall have the sole right in
its absolute discretion to accept offers to purchase the Units and
may reject any such offer, in whole or in part. The
Placement Agent has the right, in its discretion reasonably
exercised, subject to giving prior notice to the Company, to reject
any offer to purchase Units received by it, in whole or in part,
and any such rejection shall not be deemed a breach of this
Agreement.
2.4 The Units are being sold to the Purchasers at a
price of $0.81 per Unit. The purchases of the Units by
the Purchasers shall be evidenced by the execution of the
Subscription Agreements by the parties thereto.
2.5 As compensation for services rendered, on the
Closing Date (as defined in Section 4 hereof), the Company
shall pay to the Placement Agent by wire transfer of immediately
available funds to an account or accounts designated by the
Placement Agent, an aggregate amount (the “ Placement
Fee ”) equal to six percent (6%) of the gross proceeds
received by the Company from the sale of the Units on such Closing
Date.
2.6 No Units which the Company has agreed to sell
pursuant to this Agreement and the Subscription Agreements shall be
deemed to have been purchased and paid for, or sold by the Company,
until such Shares and Warrants included in the Units shall have
been delivered to the Purchaser thereof against payment by such
Purchaser. If the Company shall default in its obligations to
deliver the Shares and Warrants to a Purchaser with whom it has
entered into a binding Subscription Agreement, the Company shall
indemnify and hold the Placement Agent harmless against any loss,
claim, damage or expense arising from or as a result of such
default by the Company in accordance with the procedures set forth
in Section 8(c) herein.
3.
Representations and Warranties of the Company
. The Company represents
and warrants to, and agrees with, the Placement Agent and the
Purchasers that:
(a) The Company has prepared and filed in conformity
with the requirements of the Securities Act of 1933, as amended
(the “ Securities Act ”), and published rules
and regulations thereunder (the “ Rules and
Regulations ”) adopted by the Securities and Exchange
Commission (the “ Commission ”) a
“shelf” Registration Statement (as hereinafter defined)
on Form S-3 (File No. 333-151654), which became effective as of
June 18, 2008 (the “ Effective Date ”),
including a base prospectus relating to the Shares (the “
Base Prospectus ”), and such amendments and
supplements thereto as may have been required to the date of this
Agreement. The term “ Registration Statement ”
as used in this Agreement means the registration statement
(including all exhibits, financial schedules and all documents and
information deemed to be a part of the Registration Statement
pursuant to Rule 430A of the Rules and Regulations), as amended
and/or supplemented to the date of this Agreement, including the
Base Prospectus. The Registration Statement is effective
under the Securities Act and no stop order preventing or suspending
the effectiveness of the Registration Statement or suspending or
preventing the use of the Prospectus has been issued by the
Commission and no proceedings for that purpose have been instituted
or, to the knowledge of the Company, are threatened by the
Commission. The Company, if required by the Rules and
Regulations of the Commission, will file the Prospectus (as defined
below), with the Commission pursuant to Rule 424(b) of the Rules
and Regulations. The term “ Prospectus ” as used
in this Agreement means the prospectus, in the form in which it is
to be filed with the Commission pursuant to Rule 424(b) of the
Rules and Regulations, or, if the prospectus is not to be filed
with the Commission pursuant to Rule 424(b), the prospectus in the
form included as part of the Registration Statement as of the
Effective Date, except that if any revised prospectus or prospectus
supplement shall be provided to the Placement Agent by the Company
for use in connection with the offering and sale of the Units which
differs from the Prospectus (whether or not such revised prospectus
or prospectus supplement is required to be filed by the Company
pursuant to Rule 424(b) of the Rules and Regulations), the term
“ Prospectus ” shall refer to such revised
prospectus or prospectus supplement, as the case may be, from and
after the time it is first provided to the Placement Agent for such
use. Any preliminary prospectus or prospectus subject to completion
included in the Registration Statement or filed with the Commission
pursuant to Rule 424 of the Rules and Regulations is hereafter
called a “ Preliminary Prospectus.
” Any reference herein to the Registration
Statement, any Preliminary Prospectus or the Prospectus shall be
deemed to refer to and include the documents incorporated by
reference therein pursuant to Item 12 of Form S-3 which were filed
under the Securities Exchange Act of 1934, as amended (the “
Exchange Act ”), on or before the last to occur of the
Effective Date, the date of the Preliminary Prospectus, or the date
of the Prospectus, and any reference herein to the terms
“amend,” “amendment,” or
“supplement” with respect to the Registration
Statement, any Preliminary Prospectus or the Prospectus shall be
deemed to refer to and include (i) the filing of any document under
the Exchange Act after the Effective Date, the date of such
Preliminary Prospectus or the date of the Prospectus, as the case
may be, which is incorporated by reference and (ii) any such
document so filed. If the Company has filed an abbreviated
registration statement to register additional securities pursuant
to Rule 462(b) under the Rules and Regulations (the “
462(b) Registration Statement ”), then any reference
herein to the Registration Statement shall also be deemed to
include such 462(b) Registration Statement.
(b) The conditions to the use of Form S-3 in
connection with the offering and sale of the Securities as
contemplated hereby have been satisfied. The Registration Statement
meets, and the offering and sale of the Securities as contemplated
hereby complies with, the requirements of Rule 415 under the
Securities Act (including, without limitation, Rule 415(a)(4) and
(a)(5) of the Rules and Regulations).
(c) As of the Applicable Time (as defined below) and
as of the Closing Date, neither (i) any General Use Free Writing
Prospectus (as defined below) issued at or prior to the Applicable
Time, and the Pricing Prospectus (as defined below) and the
information included on Schedule A hereto, all considered
together (collectively, the “ General Disclosure
Package ”), (ii) any individual Limited Use Free Writing
Prospectus (as defined below) issued at or prior to the Applicable
Time nor (iii) the bona fide electronic road show (as defined in
Rule 433(h)(5) of the Rules and Regulations), if any, that has been
made available without restriction to any person, when considered
together with the General Disclosure Package, included or will
include, any untrue statement of a material fact or omitted or as
of the Closing Date will omit, to state a material fact necessary
in order to make the statements therein, in the light of the
circumstances under which they were made, not misleading;
provided, however , that the Company makes no
representations or warranties as to information contained in or
omitted from any Issuer Free Writing Prospectus, in reliance upon,
and in conformity with, written information furnished to the
Company by the Placement Agent specifically for inclusion therein,
which information the parties hereto agree is limited to the
Placement Agent’s Information (as defined in Section
17 ). As used in this paragraph (b) and
elsewhere in this Agreement:
“
Applicable Time ” means 5:00 P.M., New York
time, on the date of this Agreement.
“
General Use Free Writing Prospectus ” means any
Issuer Free Writing Prospectus that is identified on Schedule
A to this Agreement.
“
Issuer Free Writing Prospectus ” means any
“ issuer free writing prospectus, ” as defined
in Rule 433 of the Rules and Regulations relating to the Units 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) of the Rules and
Regulations.
“
Limited Use Free Writing Prospectuses ” means
any Issuer Free Writing Prospectus that is not a General Use Free
Writing Prospectus.
“
Pricing Prospectus ” means the Preliminary
Prospectus, if any, and the Base Prospectus, each as amended and
supplemented immediately prior to the Applicable Time, including
any document incorporated by reference therein and any prospectus
supplement deemed to be a part thereof.
(d) No order preventing or suspending the use of any
Preliminary Prospectus, any Issuer Free Writing Prospectus or the
Prospectus relating to the Offering has been issued by the
Commission, and no proceeding for that purpose or pursuant to
Section 8A of the Securities Act has been instituted or, to the
knowledge of the Company, threatened by the Commission, and each
Preliminary Prospectus (if any), at the time of filing thereof,
conformed in all material respects to the requirements of the
Securities Act and the Rules and Regulations, and did 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 the light of the circumstances under which
they were made, not misleading; provided, however , that the
Company makes no representations or warranties as to information
contained in or omitted from any Preliminary Prospectus, in
reliance upon, and in conformity with, written information
furnished to the Company by the Placement Agent specifically for
inclusion therein, which information the parties hereto agree is
limited to the Placement Agent’s Information (as defined in
Section 17 ).
(e) At the time the Registration Statement became
effective, at the date of this Agreement and at the Closing Date,
the Registration Statement conformed and will conform in all
material respects to the requirements of the Securities Act and the
Rules and Regulations and did not and will not contain any untrue
statement of a material fact or omit to state any material fact
required to be stated therein or necessary to make the statements
therein not misleading; the Prospectus, at the time the Prospectus
was issued and at the Closing Date, conformed and will conform in
all material respects to the requirements of the Securities Act and
the Rules and Regulations and did not and will not contain an
untrue statement of a material fact or omit to state a material
fact necessary in order to make the statements therein, in light of
the circumstances under which they were made, not misleading;
provided, however , that the foregoing representations and
warranties in this paragraph (e) shall not apply to
information contained in or omitted from the Registration Statement
or the Prospectus in reliance upon, and in conformity with, written
information furnished to the Company by the Placement Agent
specifically for inclusion therein, which information the parties
hereto agree is limited to the Placement Agent’s Information
(as defined in Section 17 ).
(f) Each Issuer Free Writing Prospectus, if any, as
of its issue date and at all subsequent times through the
completion of the public offer and sale of the Units or until any
earlier date that the Company notified or notifies the Placement
Agent as described in Section 5(e) , did not, does not and
will not include any information that conflicted, conflicts or will
conflict with the information contained in the Registration
Statement, Pricing Prospectus or the Prospectus, including any
document incorporated by reference therein and any prospectus
supplement deemed to be a part thereof that has not been superseded
or modified, or includes an untrue statement of a material fact or
omitted or would omit 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. The foregoing sentence does not
apply to statements in or omissions from any Issuer Free Writing
Prospectus in reliance upon, and in conformity with, written
information furnished to the Company by the Placement Agent
specifically for inclusion therein, which information the parties
hereto agree is limited to the Placement Agent’s Information
(as defined in Section 17 ).
(g) The documents incorporated by reference in the
Prospectus, when they became effective or were filed with the
Commission, as the case may be, conformed in all material respects
to the requirements of the Securities Act or the Exchange Act, as
applicable, and the rules and regulations of the Commission
thereunder and none of such documents contained any untrue
statement of a material fact or omitted to state any material fact
required to be stated therein or necessary to make the statements
therein, in light of the circumstances under which they were made,
not misleading; and any further documents so filed and incorporated
by reference in 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
Securities Act or the Exchange Act, as applicable, and the rules
and regulations of the Commission thereunder and will not contain
any untrue statement of a material fact or omit to state any
material fact required to be stated therein or necessary to make
the statements therein, in light of the circumstances under which
they were made, not misleading.
(h) The Company has not, directly or indirectly,
distributed and will not distribute any offering material in
connection with the Offering other than any Preliminary Prospectus,
the Prospectus and other materials, if any, permitted under the
Securities Act and consistent with Section 5(b) below. The
Company is not an “ineligible issuer” in connection
with the offering pursuant to Rules 164, 405 and 433 under the
Securities Act. The Company will file with the Commission all
Issuer Free Writing Prospectuses (other than a “road
show,” as defined in Rule 433(d)(8) of the Rules and
Regulations), if any, in the time and manner required under Rules
163(b)(2) and 433(d) of the Rules and Regulations.
(i) The Company and each of its subsidiaries (as
defined in Section 15 ) have been duly organized and are
validly existing as corporations in good standing (or the foreign
equivalent thereof) under the laws of their respective
jurisdictions of organization. The Company and each of
its subsidiaries are duly qualified to do business and are in good
standing as foreign corporations in each jurisdiction in which
their respective ownership or lease of property or the conduct of
their respective businesses requires such qualification and have
all power and authority (corporate or other) necessary to own or
hold their respective properties and to conduct the businesses in
which they are engaged, except where the failure to so qualify or
have such power or authority (i) would not have, singularly or in
the aggregate, a material adverse effect on the condition
(financial or otherwise), results of operations, assets, business
or prospects of the Company and its subsidiaries taken as a whole,
or (ii) impair in any material respect the ability of the Company
to perform its obligations under this Agreement or to consummate
any transactions contemplated by this Agreement, the General
Disclosure Package or the Prospectus (any such effect as described
in clauses (i) or (ii), a “ Material Adverse Effect
”). The Company owns or controls, directly or
indirectly, only the following corporations, partnerships, limited
liability partnerships, limited liability companies, associations
or other entities: Acute Therapeutics, Inc., a Delaware
corporation.
(j) The Company has the full right, power and
authority to enter into this Agreement, each of the Subscription
Agreements and that certain Escrow Agreement (the “ Escrow
Agreement ”) dated as of the date hereof by and among the
Company, the Placement Agent and the escrow agent named therein,
and to perform and to discharge its obligations hereunder and
thereunder; and each of this Agreement, the Escrow Agreement and
each of the Subscription Agreements has been duly authorized,
executed and delivered by the Company, and constitutes a valid and
binding obligation of the Company enforceable in accordance with
its terms, except as enforceability may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or similar laws
affecting creditors’ rights generally and except as
enforceability may be subject to general principles of equity
(regardless of whether such enforceability is considered in a
proceeding in equity or at law).
(k) The Shares and the Warrants to be issued and
sold by the Company to the Purchasers hereunder and under the
Subscription Agreements have been duly and validly authorized and,
when issued and delivered against payment therefor as provided
herein and in the Subscription Agreements, and the Warrant Shares,
when issued and delivered against payment therefor as provided in
the Warrants, will be duly and validly issued, fully paid and
non-assessable and free of any preemptive or similar rights and
will conform to the description thereof contained in the General
Disclosure Package and the Prospectus.
(l) The Company has an authorized capitalization as
set forth in the Pricing Prospectus, and all of the issued and
outstanding shares of capital stock of the Company have been duly
and validly authorized and issued, are fully paid and
non-assessable, have been issued in compliance with federal and
state securities laws, and conform to the description thereof
contained in the General Disclosure Package and the
Prospectus. As of April 30, 2009, there
were 104,453,750 shares of Common Stock issued and outstanding
and no shares of Preferred Stock, par value $0.001 of the Company
issued and outstanding and 24,570,593 shares of Common Stock
were issuable upon the exercise of all options, warrants and
convertible securities outstanding as of such date. Since such
date, the Company has not issued any securities, other than Common
Stock of the Company issued pursuant to the exercise of stock
options previously outstanding under the Company’s stock
option plans or the issuance of Common Stock pursuant to employee
stock purchase plans. All of the Company’s
options, warrants and other rights to purchase or exchange any
securities for shares of the Company’s capital stock have
been duly authorized and validly issued and were issued in
compliance with US federal and state securities
laws. None of the outstanding shares of Common Stock was
issued in violation of any preemptive rights, rights of first
refusal or other similar rights to subscribe for or purchase
securities of the Company, except for such rights as may have been
fully satisfied or waived. There are no authorized or
outstanding shares of capital stock, options, warrants, preemptive
rights, rights of first refusal or other rights to purchase, or
equity or debt securities convertible into or exchangeable or
exercisable for, any capital stock of the Company or any of its
subsidiaries other than those described above or accurately
described in the General Disclosure Package. The
description of the Company’s stock option, stock bonus and
other stock plans or arrangements, and the options or other rights
granted thereunder, as described in the General Disclosure Package
and the Prospectus, accurately and fairly present the information
required to be shown with respect to such plans, arrangements,
options and rights.
(m) All the outstanding shares of capital stock of
each subsidiary of the Company have been duly authorized and
validly issued, are fully paid and nonassessable and, except to the
extent set forth in the General Disclosure Package or the
Prospectus, are owned by the Company directly or indirectly through
one or more wholly-owned subsidiaries, free and clear of any claim,
lien, encumbrance, security interest, restriction upon voting or
transfer or any other claim of any third party.
(n) The execution, delivery and performance of this
Agreement, the Subscription Agreements and the Escrow Agreement by
the Company, the issue and sale of the Units by the Company and the
consummation of the transactions contemplated hereby and thereby
will not (with or without notice or lapse of time or both) conflict
with or result in a breach or violation of any of the terms or
provisions of, constitute a default or Debt Repayment Triggering
Event (as defined below) under, give rise to any right of
termination or other right or the cancellation or acceleration of
any right or obligation or loss of a benefit under, or give rise to
the creation or imposition of any lien, encumbrance, security
interest, claim or charge upon any property or assets of the
Company or any subsidiary pursuant to, any indenture, mortgage,
deed of trust, loan agreement or other agreement or instrument to
which the Company or any of its subsidiaries is a party or by which
the Company or any of its subsidiaries is bound or to which any of
the property or assets of the Company or any of its subsidiaries is
subject, nor will such actions result in any violation of the
provisions of (A) the charter or by-laws (or analogous governing
instruments, as applicable) of the Company or any of its
subsidiaries or (B) any law, statute, rule, regulation, judgment,
order or decree of any court or governmental agency or body,
domestic or foreign, having jurisdiction over the Company or any of
its subsidiaries or any of their properties or assets, except, with
respect to clause (B), any violation which, singularly or in the
aggregate, would not have a Material Adverse Effect. A
“Debt Repayment Triggering Event” means any event or
condition that gives, or with the giving of notice or lapse of time
would give 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 of its
subsidiaries.
(o) Except for the registration of the Units under
the Securities Act and such consents, approvals, authorizations,
registrations or qualifications as may be required under the
Exchange Act and applicable state or foreign securities laws, the
Financial Industry Regulatory Authority (“ FINRA
”) and the Nasdaq Global Market (the “ NasdaqGM
”) in connection with the offering and sale of the Units by
the Company, no consent, approval, authorization or order of, or
filing, qualification or registration with, any court or
governmental agency or body, foreign or domestic, which has not
been made, obtained or taken and is not in full force and effect,
is required for the execution, delivery and performance of this
Agreement, the Subscription Agreements and the Escrow Agreement by
the Company, the offer or sale of the Units or the consummation of
the transactions contemplated hereby or thereby.
(p) Ernst & Young LLP, who has audited certain
financial statements and related schedules included or incorporated
by reference in the Registration Statement, the General Disclosure
Package and the Prospectus, and has audited the Company’s
internal control over financial reporting and management’s
assessment thereof, is an independent registered public accounting
firm as required by the Securities Act and the Rules and
Regulations and the Public Company Accounting Oversight Board
(United States) (the “ PCAOB
”). Except as pre-approved in accordance with the
requirements set forth in Section 10A of the Exchange Act, Ernst
& Young LLP has not been engaged by the Company
to perform any “prohibited activities” (as defined in
Section 10A of the Exchange Act).
(q) The financial statements, together with the
related notes and schedules, included or incorporated by reference
in the General Disclosure Package, the Prospectus and in the
Registration Statement fairly present the financial position and
the results of operations and changes in financial position of the
Company and its consolidated subsidiaries and other consolidated
entities at the respective dates or for the respective periods
therein specified. Such statements and related notes and
schedules have been prepared in accordance with the generally
accepted accounting principles in the United States (“
GAAP ”) applied on a consistent basis throughout the
periods involved except as may be set forth in the related notes
included or incorporated by reference in the General Disclosure
Package, and except that unaudited financial statements may not
contain footnotes required by GAAP. The financial
statements, together with the related notes and schedules, included
or incorporated by reference in the General Disclosure Package and
the Prospectus comply in all material respects with the Securities
Act, the Exchange Act, and the Rules and Regulations and the rules
and regulations under the Exchange Act. No other
financial statements or supporting schedules or exhibits are
required by the Securities Act or the Rules and Regulations to be
described, or included or incorporated by reference in the
Registration Statement, the General Disclosure Package or the
Prospectus. There is no pro forma or as adjusted
financial information which is required to be included in the
Registration Statement, the General Disclosure Package, or and the
Prospectus or a document incorporated by reference therein in
accordance with the Securities Act and the Rules and Regulations
which has not been included or incorporated as so
required.
(r) Neither the Company nor any of its subsidiaries
has sustained, since the date of the latest audited financial
statements included or incorporated by reference in the General
Disclosure Package, any material loss or interference with its
business from fire, explosion, flood or other calamity, whether or
not covered by insurance, or from any labor dispute or court or
governmental action, order or decree, otherwise than as set forth
or contemplated in the General Disclosure Package; and, since such
date, there has not been any change in the capital stock (other
than Common Stock of the Company issued pursuant to the exercise of
stock options previously outstanding under the Company’s
stock option plans or the issuance of Common Stock pursuant to
employee stock purchase plans) or long-term debt of the Company or
any of its subsidiaries, or any material adverse changes, or any
development involving a prospective material adverse change, in or
affecting the business, assets, general affairs, management,
financial position, prospects, stockholders’ equity or
results of operations of the Company and its subsidiaries taken as
a whole, otherwise than as set forth or contemplated in the General
Disclosure Package.
(s) Except as set forth in the General Disclosure
Package, there is no legal or governmental action, suit, claim or
proceeding pending to which the Company or any of its subsidiaries
is a party or of which any property or assets of the Company or any
of its subsidiaries is the subject which is required to be
described in the Registration Statement, the General Disclosure
Package or the Prospectus or a document incorporated by reference
therein and is not described therein, or which, singularly or in
the aggregate, if determined adversely to the Company or any of its
subsidiaries, would be likely to have a Material Adverse Effect or
prevent or adversely affect the ability of the Company to perform
its obligations under this Agreement or the consummation of the
transactions contemplated hereby; and to the best of the
Company’s knowledge, except as set forth in the General
Disclosure Package, no such proceedings are threatened or
contemplated by governmental authorities or threatened by
others.
(t) Neither the Company nor any of its subsidiaries
is in (i) violation of its charter or by-laws (or analogous
governing instrument, as applicable), (ii) default in any respect,
and no event has occurred which, with notice or lapse of time or
both, would constitute such a default, in the due performance or
observance of any term, covenant or condition contained in any
indenture, mortgage, deed of trust, loan agreement, lease or other
agreement or instrument to which it is a party or by which it is
bound or to which any of its property or assets is subject or (iii)
violation in any respect of any statute, law, ordinance,
governmental rule, regulation or court order, decree or judgment to
which it or its property or assets may be subject except, in the
case of clauses (ii) and (iii) of this paragraph (t), for any
violations or defaults which, singularly or in the aggregate, would
not have a Material Adverse Effect.
(u) The Company and each of its subsidiaries
possesses all licenses, certificates, authorizations and permits
issued by, and have made all declarations and filings with, the
appropriate local, state, federal or foreign regulatory agencies or
bodies which are necessary or desirable for the ownership of their
respective properties or the conduct of their respective businesses
(including, without limitation, those administered by the Food and
Drug Administration of the U.S. Department of Health and Human
Services (the “ FDA ”) or by any foreign,
federal, state or local governmental or regulatory authority
performing functions similar to those performed by the FDA) as
described in the General Disclosure Package and the Prospectus
(collectively, the “ Governmental Permits ”)
except where any failures to possess or make the same, singularly
or in the aggregate, would not have a Material Adverse
Effect. The Company and its subsidiaries are in
compliance with all such Governmental Permits; all such
Governmental Permits are valid and in full force and effect, except
where the validity or failure to be in full force and effect would
not, singularly or in the aggregate, have a Material Adverse
Effect. All such Governmental Permits are free and clear
of any restriction or condition that are in addition to, or
materially different from those normally applicable to similar
licenses, certificates, authorizations and permits. Neither the
Company nor any subsidiary has received notification of any
revocation or modification (or proceedings related thereto) of any
such Governmental Permit and the Company has no reason to believe
that any such Governmental Permit will not be renewed, except as
set forth in or contemplated by the General Disclosure
Package.
(v) The clinical trials conducted by or on behalf of
or sponsored by the Company or in which the Company or its product
candidates have participated that are described in the General
Disclosure Package and Prospectus or the results of which are
referred to in the General Disclosure Package or Prospectus were
and, if still pending, are being conducted in all material respects
in accordance with medical and scientific research procedures that
the Company reasonably believes are appropriate. The descriptions
in the General Disclosure Package and Prospectus of the results of
such clinical trials are accurate and fairly present the data
derived from such clinical trials, and the Company has no knowledge
of any studies or tests performed by or on behalf of the Company
the results of which are materially inconsistent with or otherwise
materially call into question the results described or referred to
in the General Disclosure Package and Prospectus. Except
to the extent disclosed in the General Disclosure Package and the
Prospectus, the Company has not received any notices or other
correspondence from the FDA or any other governmental agency
requiring the termination, suspension or modification of any
clinical trials that are described in the General Disclosure
Package or Prospectus or the results of which are referred to in
the General Disclosure Package or Prospectus.
(w) Neither the Company nor any of its subsidiaries
is or, after giving effect to the offering and sale of the
Securities, including the issuance, offering and sale of the
Warrant Shares, and the application of the proceeds thereof as
described in the General Disclosure Package and the Prospectus,
will become an “investment company” within the meaning
of the Investment Company Act of 1940, as amended, and the rules
and regulations of the Commission thereunder.
(x) Neither the Company, its subsidiaries nor, to
the Company’s knowledge, any of the Company’s or its
subsidiaries’ officers, directors or affiliates has taken or
will take, directly or indirectly, any action designed or intended
to stabilize or manipulate the price of any security of the
Company, or which caused or resulted in, or which might in the
future reasonably be expected to cause or result in, stabilization
or manipulation of the price of any security of the
Company.
(y) The Company and its subsidiaries owns or
possesses the right to use all material patents, trademarks,
trademark registrations, service marks, service mark registrations,
trade names, copyrights, licenses, inventions, software, databases,
know-how, Internet domain names, trade secrets and other unpatented
and/or unpatentable proprietary or confidential information,
systems or procedures, and other intellectual property
(collectively, “ Intellectual Property ”)
necessary to carry on their respective businesses as currently
conducted, and as proposed to be conducted and described in the
General Disclosure Package and the Prospectus, and the
Company is not aware of any claim to the contrary or any challenge
by any other person to the rights of the Company and its
subsidiaries with respect to the foregoing except for those that
could not have a Material Adverse Effect. The
Intellectual Property licenses described in the General Disclosure
Package and the Prospectus are valid, binding upon, and enforceable
by or against the parties thereto in accordance to its
terms. The Company and each of its subsidiaries has
complied in all material respects with, and is not in breach nor
has received any asserted or threatened claim of breach of, any
Intellectual Property license, except for any such breach that
would not individually or in the aggregate have a Material Adverse
Effect, and the Company has no knowledge of any breach or
anticipated breach by any other person to any Intellectual Property
license. The Company’s and each of its
subsidiaries’ businesses as now conducted and as proposed to
be conducted does not and will not infringe or conflict with any
valid patents, trademarks, service marks, trade names, copyrights,
trade secrets, licenses or other Intellectual Property or franchise
right of any person. To its knowledge, no claim has been
made against the Company or any of its subsidiaries alleging the
infringement by the Company or any of its subsidiaries of any
patent, trademark, service mark, trade name, copyright, trade
secret, license in or other intellectual property right or
franchise right of any person. The Company and each of
its subsidiaries has taken all reasonable steps to protect,
maintain and safeguard its rights in all Intellectual Property,
including the execution of appropriate nondisclosure and
confidentiality agreements. The consummation of the
transactions contemplated by this Agreement will not result in the
loss or impairment of or payment of any additional amounts with
respect to, nor require the consent of any other person in respect
of, the Company’s or any of its subsidiaries’ right to
own, use, or hold for use any of the Intellectual Property as
owned, used or held for use in the conduct of the businesses as
currently conducted. With respect to the use of the
software in the Company’s or any of its subsidiaries’
businesses as they are currently conducted, the Company nor any of
its subsidiaries has experienced any material defects in such
software including any material error or omission in the processing
of any transactions other than defects which have been corrected,
and to the knowledge of the Company, no such software contains any
device or feature designed to disrupt, disable, or otherwise impair
the functioning of any software or is subject to the terms of any
“open source” or other similar license that provides
for the source code of the software to be publicly distributed or
dedicated to the public. The Company and each of its
subsidiaries has at all times complied with all applicable laws
relating to privacy, data protection, and the collection and use of
personal information collected, used, or held for use by the
Company and any of its subsidiaries in the conduct of the
Company’s and its subsidiaries businesses, except for any
such breach that would individually or in the aggregate have a
Material Adverse Effect. No claims have been asserted or
threatened against the Company or any of its subsidiaries alleging
a violation of any person’s privacy or personal information
or data rights and the consummation of the transactions
contemplated hereby will not breach or otherwise cause any
violation of any law related to privacy, data protection, or the
collection and use of personal information collected, used, or held
for use by the Company or any of its subsidiaries in the conduct of
the Company’s or any of its subsidiaries’
businesses. The Company and each of its subsidiaries
takes reasonable measures to ensure that such information is
protected against unauthorized access, use, modification, or other
misuse.
(z) Neither the Company nor its subsidiaries own any
real property. The Company and each of its subsidiaries
have good and marketable title in fee simple to, or have valid
rights to lease or otherwise use, all items of real or personal
property, as described in the General Disclosure Package, which are
material to the business of the Company and its subsidiaries taken
as a whole, in each case free and clear of all liens, encumbrances,
security interests, claims and defects that do not, singularly or
in the aggregate, materially 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, except for
those liens, encumbrances, security interests, claims and defects
that would not have a Material Adverse Effect; and all of the
leases and subleases material to the business of the Company and
its subsidiaries, considered as one enterprise, and under which the
Company or any of its subsidiaries holds properties described in
the General Disclosure Package and the Prospectus, are in full
force and effect, and neither the Company nor any subsidiary has
received 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.
(aa)
No labor disturbance by the
employees of the Company or any of its subsidiaries exists or, to
the best of the Company’s knowledge, is threatened or
imminent, and the Company is not aware of any existing or imminent
labor disturbance by the employees of any of its or its
subsidiaries’ principal suppliers, manufacturers, customers
or contractors, that could reasonably be expected, singularly or in
the aggregate, to have a Material Adverse Effect. The
Company is not aware that any key employee or significant group of
employees of the Company or any subsidiary plans to terminate
employment with the Company or any such subsidiary.
(bb)
No “prohibited
transaction” (as defined in Section 406 of the Employee
Retirement Income Security Act of 1974, as amended, including the
regulations and published interpretations thereunder (“
ERISA ”), or Section 4975 of the Internal Revenue Code
of 1986, as amended from time to time (the “ Code
”)) or “accumulated funding deficiency” (as
defined in Section 302 of ERISA) or any of the events set forth in
Section 4043(b) of ERISA (other than events with respect to which
the thirty (30)-day notice requirement under Section 4043 of ERISA
has been waived) has occurred or could reasonably be expected to
occur with respect to any employee benefit plan of the Company or
any of its subsidiaries which could, singularly or in the
aggregate, have a Material Adverse Effect. Each employee
benefit plan of the Company or any of its subsidiaries is in
compliance in all material respects with applicable law, including
ERISA and the Code. The Company and its subsidiaries have not
incurred and could not reasonably be expected to incur liability
under Title IV of ERISA with respect to the termination of, or
withdrawal from, any pension plan (as defined in
ERISA). Each pension plan for which the Company or any
of its subsidiaries would have any liability that is intended to be
qualified under Section 401(a) of the Code is so qualified, and
nothing has occurred, whether by action or by failure to act, which
could, singularly or in the aggregate, cause the loss of such
qualification.
(cc)
The Company and its subsidiaries are
in compliance in all material respects with all foreign, federal,
state and local rules, laws and regulations relating to the use,
treatment, storage and disposal of hazardous or toxic substances or
waste and protection of health and safety or the environment which
are applicable to their businesses (“ Environmental
Laws ”), except where the failure to comply would not,
singularly or in the aggregate, have a Material Adverse
Effect. There has been no storage, generation,
transportation, handling, treatment, disposal, discharge, emission,
or other release of any kind of toxic or other wastes or other
hazardous substances by, due to, or caused by the Company or any of
its subsidiaries (or, to the Company’s knowledge, any other
entity for whose acts or omissions the Company or any of its
subsidiaries is or may otherwise be liable) upon any of the
property now or previously owned or leased by the Company or any of
its subsidiaries, or upon any other property, in violation of any
law, statute, ordinance, rule, regulation, order, judgment, decree
or permit or which would, under any law, statute, ordinance, rule
(including rule of common law), regulation, order, judgment, decree
or permit, give rise to any liability, except for any violation or
liability which would not have, singularly or in the aggregate with
all such violations and liabilities, a Material Adverse Effect; and
there has been no disposal, discharge, emission or other release of
any kind onto such property or into the environment surrounding
such property of any toxic or other wastes or other hazardous
substances with respect to which the Company has knowledge, except
for any such disposal, discharge, emission, or other release of any
kind which would not have, singularly or in the aggregate with all
such discharges and other releases, a Material Adverse
Effect. In the ordinary course of business, the Company
and its subsidiaries conduct periodic reviews of the effect of
Environmental Laws on their business and assets, in the course of
which they identify and evaluate associated costs and liabilities
(including, without limitation, any capital or operating
expenditures required for clean-up, closure of properties or
compliance with Environmental Laws or Governmental Permits issued
thereunder, any related constraints on operating activities and any
potential liabilities to third parties). On the basis of
such reviews, the Company and its subsidiaries have reasonably
concluded that such associated costs and liabilities would not
have, singularly or in the aggregate, a Material Adverse
Effect.
(dd)
The Company and its subsidiaries,
each (i) has timely filed all necessary federal, state, local and
foreign tax returns that are required to be filed or has requested
extensions thereof, and all such returns were true, complete and
correct, (ii) has paid all federal, state, local and foreign taxes,
assessments, governmental or other charges due and payable for
which it is liable, including, without limitation, all sales and
use taxes and all taxes which the Company or any of its
subsidiaries is obligated to withhold from amounts owing to
employees, creditors and third parties, and (iii) does not have any
tax deficiency or claims outstanding or assessed or, to the best of
its knowledge, proposed against any of them, except those, in each
of the cases described in clauses (i), (ii) and (iii) of this
paragraph (dd) , that would not, singularly or in the
aggregate, have a Material Adverse Effect. The Company
and its subsidiaries, each has not engaged in any transaction which
is a corporate tax shelter or which could be characterized as such
by the Internal Revenue Service or any other taxing
authority. The accruals and reserves on the books and
records of the Company and its subsidiaries in respect of tax
liabilities for any taxable period not yet finally determined are
adequate to meet any assessments and related liabilities for any
such period, and since December 31, 2008 the Company and its
subsidiaries each has not incurred any liability for taxes other
than in the ordinary course.
(ee)
The Company and each of its
subsidiaries carries, or is covered by, insurance provided by
recognized, financially sound and reputable institutions with
policies in such amounts and covering such risks as the Company
reasonably considers adequate for the conduct of their respective
businesses and the value of their respective properties and as is
customary for companies engaged in similar businesses in similar
industries. The Company has no reason to believe that it
or any subsidiary will not be able (i) to renew its existing
insurance coverage as and when such policies expire or (ii) to
obtain comparable coverage from similar institutions as may be
necessary or appropriate to conduct its business as now conducted
and at a cost that would not result in a Material Adverse
Effect.
(ff)
The Company maintains a system of
internal accounting and other controls sufficient to provide
reasonable assurances that (i) transactions are executed in
accordance with management’s general or specific
authorizations; (ii) transactions are recorded as necessary to
permit preparation of financial statements in conformity with GAAP
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 accountability for
assets is compared with existing assets at reasonable intervals and
appropriate action is taken with respect to any
differences. Except as described in the General
Disclosure Package, since the end of the Company’s most
recent audited fiscal year, there as been (A) no material weakness
in the Company’s internal control over financial reporting
(whether or not remediated) and (B) no change in the
Company’s internal control over financial reporting that has
materially affected, or is reasonably likely to materially affect,
the Company’s internal control over financial
reporting.
(gg) The minute books of the Company and each of its
subsidiaries that would be a “significant subsidiary”
within the meaning of Rule 1-02(w) of Regulation S-X under the
Exchange Act (such a significant subsidiary of the Company, a
“ Significant Subsidiary ”) have been made
available to the Placement Agent and counsel for the Placement
Agent, and such books (i) contain a complete summary of all
meetings and actions of the board of directors (including each
board committee) as of April 18, 2009 and shareholders of the
Company (or analogous governing bodies and interest holders, as
applicable), and each of its Significant Subsidiaries since the
time of its respective incorporation or organization through the
date of the latest meeting and action, and (ii) accurately in all
material respects reflect all transactions referred to in such
minutes. There are no material t
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