Exhibit 10.1
Execution
Copy
4,610,000
Shares
DISCOVERY LABORATORIES,
INC.
Shares of Common
Stock
($0.001 par value)
PLACEMENT AGENT
AGREEMENT
February 17, 2005
SG COWEN &
CO., LLC
1221 Avenue of
the Americas
New York, New
York 10020
Dear
Sirs:
Discovery Laboratories, Inc., a Delaware
corporation (the “ Company ”),
proposes to sell to the Purchasers, pursuant to the terms 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
”), an aggregate of 4,610,000 shares of Common Stock, par
value $0.001 per share (the “ Common Stock
”), of the Company. The aggregate of 4,610,000 shares so
proposed to be sold is hereinafter referred to as the “
Stock .” The Company hereby confirms its
agreement with SG Cowen & Co., LLC (“ SG
Cowen ”) as follows (certain terms used herein are
defined in Section 13 hereof):
1.
AGREEMENT TO ACT AS PLACEMENT AGENT; PLACEMENT OF
SECURITIES . 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:
(a)
The Company hereby authorizes SG Cowen to act as its
exclusive agent (in such capacity, the “ Placement
Agent ”) to solicit offers for the purchase of all
or part of the Stock from the Company in connection with the
proposed offering of the Stock (the “
Offering ”). Until the earlier of the
termination of this Agreement or the Closing Date (as defined in
Section 3 hereof), the Company shall not, without the prior
consent of the Placement Agent, solicit or accept offers to
purchase Stock otherwise than through the Placement
Agent.
(b)
The Placement Agent agrees, as agent of the Company, to use
its commercially reasonable efforts to solicit offers to purchase
the Stock from the Company on the terms and subject to the
conditions set forth in the Base Prospectus (as defined below) and
the Prospectus Supplement (as defined below). The Placement Agent
shall make commercially reasonable efforts to assist the Company in
obtaining performance by each Purchaser whose offer to purchase
Stock has been 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
purchase any Stock for its own account and, in soliciting purchases
of Stock, the Placement Agent shall act solely as the Company's
agent and not as principal. Notwithstanding the foregoing and
except as otherwise provided in Section 1(c) , 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 Stock 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).
(c)
Subject to the provisions of this Section 1 , offers
for the purchase of Stock may be solicited by the Placement Agent
as agent for the Company at such times and in such amounts as the
Placement Agent deems advisable. The Placement Agent shall
communicate to the Company, orally or in writing, each reasonable
offer to purchase Stock 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 Stock and in its absolute discretion
may reject any such offer, in whole or in part. The Placement Agent
shall have the right, in its discretion reasonably exercised,
subject to giving prior notice to the Company, to reject any offer
to purchase Stock received by it, in whole or in part, and any such
rejection shall not be deemed a breach of its agreement contained
herein.
(d)
The purchases of the Stock by the Purchasers shall be
evidenced by the execution of the Subscription Agreements by each
of the parties thereto.
(e)
As compensation for services rendered, on the Closing Date
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 amount equal to five percent (5.0%) of the
gross proceeds received by the Company from the sale of the Stock
on such Closing Date.
(f)
No Stock which the Company has agreed to sell pursuant to
this Agreement shall be deemed to have been purchased and paid for,
or sold by the Company, until such Stock shall have been delivered
to the Purchaser thereof against payment by such Purchaser. If the
Company shall default in its obligations to deliver Stock 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 or damage arising from or as a
result of such default by the Company.
2.
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 meets the requirements for use of Form S-3 under
the Securities Act of 1933, as amended (the “
Securities Act ”), and has filed with the
Securities and Exchange Commission (the “
Commission ”) a registration statement on
such form (Registration File No. 333-111360), which became
effective as of January 7, 2004, for the registration under the
Securities Act of the Stock (the “ Initial
Registration Statement ”). The Company has also
filed a registration statement increasing the amount of securities
registered under the Initial Registration Statement pursuant to
Rule 462(b) under Securities Act and the rules and regulations (the
“ Rules and Regulations ”) of the
Commission promulgated thereunder, which became effective
immediately upon filing (the “ Rule 462(b)
Registration Statement ”). Such Initial Registration
Statement, together with the Rule 462(b) Registration Statement,
meets the requirements set forth in Rule 415(a)(1)(x) under the
Securities Act and complies in all material respects with said
Rule. The Company will file with the Commission pursuant to Rule
424(b) under the Securities Act and the Rules and Regulations, a
supplement to the form of prospectus included in such Initial
Registration Statement relating to the placement of the Stock and
the plan of distribution thereof and has advised the Placement
Agent of all further information (financial and other) with respect
to the Company required to be set forth therein. Such Initial
Registration Statement and the Rule 462(b) Registration Statement,
including the exhibits thereto, as amended at the date of this
Agreement, are hereinafter collectively called the “
Registration Statements ”; such prospectus
in the form in which it appears in the Initial Registration
Statement is hereinafter called the “ Base
Prospectus ”; and the supplemented form of
prospectus, in the form in which it will be filed with the
Commission pursuant to Rule 424(b) (including the Base Prospectus
as so supplemented) is hereinafter called a “
Prospectus Supplement .” Any reference
herein to the Registration Statements, the Base Prospectus or the
Prospectus Supplement shall be deemed to refer to and include the
documents incorporated by reference therein (the “
Incorporated Documents ”) 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 date of this Agreement, or the issue
date of the Base Prospectus or the Prospectus Supplement, as the
case may be; and any reference herein to the terms
“amend,” “amendment” or
“supplement” with respect to the Registration
Statements, the Base Prospectus or the Prospectus Supplement shall
be deemed to refer to and include the filing of any document under
the Exchange Act after the date of this Agreement, or the issue
date of the Base Prospectus or the Prospectus Supplement, as the
case may be, deemed to be incorporated therein by reference. All
references in this Agreement to financial statements and schedules
and other information which is “contained,”
“included,” “described,” “set
forth” or “stated” in the Registration
Statements, the Base Prospectus or the Prospectus Supplement (and
all other references of like import) shall be deemed to mean and
include all such financial statements and schedules and other
information which is or is deemed to be incorporated by reference
in the Registration Statements, the Base Prospectus or the
Prospectus Supplement, as the case may be. No stop order suspending
the effectiveness of the Registration Statements or the use of the
Base Prospectus or the Prospectus Supplement has been issued, and
no proceeding for any such purpose is pending or has been initiated
or, to the Company's knowledge, is threatened by the Commission.
All references in this Agreement to the Initial Registration
Statement, the Rule 462(b) Registration Statement, a Base
Prospectus and the Prospectus Supplement, or any amendments or
supplements to any of the foregoing shall be deemed to include any
copy thereof filed with the Commission pursuant to its Electronic
Data Gathering, Analysis and Retrieval System (“
EDGAR ”).
(b)
The Registration Statements (and any further documents to be
filed with the Commission) contain all exhibits and schedules as
required by the Securities Act. Each of the Initial Registration
Statement, the 462(b) Registration Statement and any post-effective
amendment thereto, at the time it became effective, complied in all
material respects with the Securities Act and the Exchange Act and
the applicable Rules and Regulations and did not and, as amended or
supplemented, if applicable, will not, contain any 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 not
misleading. The Base Prospectus and the Prospectus Supplement, each
as of its respective date, comply in all material respects with the
Securities Act and the Exchange Act and the applicable Rules and
Regulations. Each of the Base Prospectus and the Prospectus
Supplement, as amended or supplemented, did not and will not
contain as of the date thereof any 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. The Incorporated Documents, when
they were filed with the Commission, conformed in all material
respects to the requirements of the Exchange Act and the applicable
Rules and Regulations, and none of such documents, when they were
filed with the Commission, contained any untrue statement of a
material fact or omitted to state a material fact 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 Base Prospectus or Prospectus
Supplement, when such documents are filed with the Commission, will
conform in all material respects to the requirements of the
Exchange Act and the applicable Rules and Regulations, as
applicable, and will not contain any untrue statement of a material
fact or omit to state a material fact necessary to make the
statements therein, in light of the circumstances under which they
were made, not misleading. Notwithstanding the foregoing, the
Company makes no representations or warranties as to information,
if any, contained in or omitted from the Prospectus Supplement or
any amendment thereof or supplement thereto in reliance upon and in
conformity with information furnished in writing to the Company by
or on behalf of the Placement Agent specifically for use in the
Registration Statements or the Prospectus Supplement, which
information the parties hereto agree is limited to the Placement
Agent’s Information as defined in Section 15 . No
post-effective amendment to the Registration Statements reflecting
any facts or events arising after the date thereof which represent,
individually or in the aggregate, a fundamental change in the
information set forth therein is required to be filed with the
Commission. There are no documents required to be filed with the
Commission in connection with the transaction contemplated hereby
that (x) have not been filed as required pursuant to the Securities
Act or (y) will not be filed within the requisite time period.
There are no contracts or other documents required to be described
in the Base Prospectus or Prospectus Supplement, or to be filed as
exhibits or schedules to the Registration Statements, which have
not been described or filed as required.
(c)
The Company has delivered, or will as promptly as practicable
deliver, to the Placement Agent complete conformed copies of the
Registration Statements and of each consent and certificate of
experts filed as a part thereof, and conformed copies of the
Registration Statements (without exhibits) and the Base Prospectus
and the Prospectus Supplement, as amended or supplemented, in such
quantities and at such places as the Placement Agent reasonably
requests. Neither the Company nor any of its directors and officers
has distributed and none of them will distribute, prior to the
completion of the distribution of Stock, any offering material in
connection with the offering and sale of the Stock other than the
Base Prospectus, the Prospectus Supplement, the Registration
Statements, copies of the documents incorporated by reference
therein and any other materials permitted by the Securities
Act.
(d)
Each of the Company and Acute Therapeutics, Inc., a
wholly-owned subsidiary of the Company (the “
Subsidiary ”), have been duly organized and
are validly existing as corporations or other legal entities in
good standing (or the equivalent thereof, if any) under the laws of
their respective jurisdictions of incorporation, are duly qualified
to do business and are in good standing (or the equivalent thereof,
if any) 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 necessary to own or hold their respective
properties and to conduct the businesses in which they are engaged,
except where the failure to be so qualified and in good standing or
have such power or authority would not have, singularly or in the
aggregate, a material adverse effect on the condition (financial or
otherwise), results of operations, business, properties or
prospects of the Company and its Subsidiary taken as a whole (a
“ Material Adverse Effect
”).
(e)
The Stock to be issued and sold by the Company hereunder and
under the Subscription Agreements has been duly and validly
authorized and, when issued and delivered against payment therefor
as provided herein, will be duly and validly issued, fully paid and
nonassessable and free of any preemptive or similar rights. The
Stock conforms to the description thereof contained in the Base
Prospectus and the Prospectus Supplement.
(f)
The Company has an authorized capitalization as set forth in
the Base Prospectus and the Prospectus Supplement, 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 Base Prospectus and the Prospectus Supplement.
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 options or authorized or
outstanding 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 its Subsidiary that have been granted by the Company
other than those accurately described in the Base Prospectus and
the Prospectus Supplement. 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 Base Prospectus and the Prospectus Supplement accurately and
fairly present the information required to be shown with respect to
such plans, arrangements, options and rights.
(g)
All the outstanding shares of capital stock of the Subsidiary
have been duly authorized and validly issued, are fully paid and
nonassessable and, except to the extent set forth in the Base
Prospectus and the Prospectus Supplement, are owned directly by the
Company, free and clear of any claim, lien, encumbrance, security
interest, defect or restriction upon voting or transfer or any
other claim of any kind (“ Liens
”).
(h)
The Company has the full right, power and authority to enter
into this Agreement and each of the Subscription Agreements and to
perform and to discharge its obligations hereunder and thereunder;
and each of this 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).
(i)
The execution, delivery and performance of this Agreement and
the Subscription Agreements by the Company and the consummation of
the transactions contemplated hereby and thereby will not conflict
with or result in a breach or violation of any of the terms or
provisions of, or constitute a default under, any indenture,
mortgage, deed of trust, loan agreement or other agreement or
instrument to which the Company or its Subsidiary is a party or by
which the Company or its Subsidiary is bound or to which any of the
property or assets of the Company or its Subsidiary is subject, nor
will such actions result in any violation of the provisions of (A)
the charter or by-laws of the Company or its Subsidiary or (B) any
statute, law, rule or regulation or any judgment, order or decree
of any court or governmental agency or body having jurisdiction
over the Company or its Subsidiary 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.
(j)
There is no franchise, contract, lease, instrument or other
document of a character required by the Securities Act or the Rules
and Regulations to be described in the Base Prospectus and the
Prospectus Supplement, or to be filed as an exhibit to the
Registration Statements, which is not described or filed as
required; and all statements summarizing any such franchises,
contracts, leases, instruments or other documents or legal matters
contained in the Registration Statements are accurate and complete
in all material respects. Other than as described in the Base
Prospectus and the Prospectus Supplement, no such franchise,
contract, lease, instrument or other document has been suspended or
terminated for convenience or default by the Company or any of the
other parties thereto, the Company has not sent or received any
communication regarding intent not to renew any such franchise,
contract, lease, instrument or other document, and the Company has
not received notice or any other knowledge of any such pending or
threatened suspension, termination or non-renewal, except for such
pending or threatened suspensions, terminations or non-renewals
that would not reasonably be expected to, singularly or in the
aggregate, have a Material Adverse Effect.
(k)
All existing minute books of the Company and its Subsidiary,
including all existing records of all meetings and actions of the
board of directors (including, Audit, Compensation,
Nomination/Corporate Governance and other board committees) and
stockholders of the Company through the date of the latest meeting
and action (collectively, the “ Corporate
Records ”) have been made available to the Placement
Agent and counsel for the Placement Agent. All such Corporate
Records are complete and accurately reflect, in all material
respects, all transactions referred to in such Corporate Records.
There are no material transactions, agreements or other actions of
the Company that are not properly approved and/or recorded in the
Corporate Records.
(l)
No consent, approval, authorization, filing with or order of
or registration with, any court or governmental agency or body is
required in connection with the transactions contemplated herein or
in the Subscription Agreements, except such as have been obtained
or made under the Securities Act or the Exchange Act, such as may
be required under the securities, or blue sky, laws of any
jurisdiction in connection with the offer and sale of the Stock by
the Company in the manner contemplated herein and in the Base
Prospectus and the Prospectus Supplement, and the approval by
Nasdaq of the Nasdaq Notification Form for the Additional Listing
of Shares on Nasdaq.
(m)
Except as described in the Base Prospectus and the Prospectus
Supplement, (i) no person has the right, contractual or otherwise,
to cause the Company to issue or sell to it any shares of Common
Stock or shares of any other capital stock or other equity
interests of the Company, (ii) no person has any preemptive rights,
resale rights, rights of first refusal or other rights to purchase
any shares of Common Stock or shares of any other capital stock or
other securities of the Company, and (iii) except as provided
herein, no person has the right to act as an underwriter, placement
agent or financial advisor to the Company in connection with and as
a result of the offer and sale of the Stock, in the case of each of
the foregoing clauses (i), (ii) and (iii), whether as a result of
the filing or effectiveness of the Registration Statements or the
sale of the Stock as contemplated thereby or otherwise; no person
has the right, contractual or otherwise, to cause the Company to
register under the Securities Act any shares of Common Stock or
shares of any other capital stock or other securities of the
Company, or to include any such shares or interests in the
Registration Statements or the offering contemplated thereby,
whether as a result of the filing or effectiveness of the
Registration Statements or the sale of the Stock as contemplated
thereby or otherwise, except for persons and entities who have
expressly waived such right or who have been given timely and
proper notice and have failed to exercise such right within the
time or times required under the terms and conditions of such
right, and the Company is not required to file any registration
statement for the registration of any securities of any person or
register any such securities pursuant to any other registration
statement filed by the Company under the Securities Act for a
period of at least 90 days after the date hereof.
(n)
The financial statements, together with the related notes and
schedules, of the Company included in the Base Prospectus, the
Prospectus Supplement or the Registration Statements, or
incorporated by reference therein, as the case may be, present
fairly the financial condition, results of operations and cash
flows of the Company and its consolidated subsidiary as of the
dates and for the periods indicated, comply in all material
respects with the Securities Act and the Rules and Regulations
thereunder, and have been prepared in conformity with generally
accepted accounting principles applied on a consistent basis
throughout the periods involved. No other financial statements or
supporting schedules or exhibits are required by the Securities Act
or the Rules and Regulations thereunder to be included in the Base
Prospectus, the Prospectus Supplement or the Registration
Statements, or incorporated by reference therein, as the case may
be. As of January 31, 2005, the Company had cash and marketable
securities as set forth in that certain representation letter,
dated as of the date of this Agreement, delivered by the Company to
the Placement Agent.
(o)
Except as set forth in the Base Prospectus and the Prospectus
Supplement, there is no legal or governmental proceeding pending to
which the Company or its Subsidiary is a party or of which any
property or assets of the Company or its Subsidiary is the subject
which is required to be described in the Base Prospectus or the
Prospectus Supplement and is not described therein, or which,
singularly or in the aggregate, if determined adversely to the
Company or its Subsidiary, 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; and to the
best of the Company’s knowledge, except as set forth in the
Base Prospectus and the Prospectus Supplement, no such proceedings
are threatened or contemplated by governmental authorities or
threatened by others.
(p)
The Company and its Subsidiary have good and marketable title
to all property (real and personal) described in the Registration
Statements, the Base Prospectus and the Prospectus Supplement as
being owned by the Company or its Subsidiary, free and clear of all
Liens, except for those Liens that do not materially interfere with
the use made or proposed to be made of such property by the Company
or its Subsidiary or that would not have a Material Adverse Effect;
all the property described in the Registration Statements, the Base
Prospectus and the Prospectus Supplement as being held under lease
by the Company or its Subsidiary is held thereby under valid,
subsisting and enforceable leases except where the failure to be
valid, subsisting or enforceable would not have a Material Adverse
Effect.
(q)
Neither the Company nor its Subsidiary is (i) in violation of
any provision of its charter or bylaws, (ii) in 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 of
any indenture, contract, lease, mortgage, deed of trust, note
agreement, loan agreement or other agreement, obligation,
condition, covenant 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) in violation in any respect of any statute, law,
rule, regulation, ordinance, judgment, order or decree of any
court, regulatory body, administrative agency, governmental body,
arbitrator or other authority having jurisdiction over the Company,
its Subsidiary or any of its properties, as applicable (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),
except, with respect to clauses (ii) and (iii), any violations or
defaults which, singularly or in the aggregate, would not have a
Material Adverse Effect.
(r)
The contracts described in the Company’s regular
reports on Forms 10-Q, 10-K, and 8-K as filed by the Company since
March 15, 2004 with the Commission or incorporated by reference
therein that are material to the Company are in full force and
effect on the date hereof, and neither the Company nor, to the
Company's knowledge, any other party to such contracts is in breach
of or default under any of such contracts which would have a
Material Adverse Effect.
(s)
No labor problem or dispute with the employees of the Company
exists or, to the Company’s knowledge, is threatened or
imminent, which might be expected to have a Material Adverse
Effect. The Company is not aware that any key employee or
significant group of employees of the Company or its Subsidiary
plans to terminate employment with the Company or such
Subsidiary.
(t)
Each of the Company and its Subsidiary has fulfilled its
obligations, if any, under the minimum funding standards of Section
302 of the United States Employee Retirement Income Security Act of
1974 (“ ERISA ”) and the regulations
and published interpretations thereunder with respect to each
“ plan ” (as defined in Section 3(3)
of ERISA and such regulations and published interpretations) in
which employees of the Company and its Subsidiary are eligible to
participate and each such plan is in compliance in all material
respects with the presently applicable provisions of ERISA and such
regulations and published interpretations. No “
prohibited transaction ” (as defined in
Section 406 of ERISA, or Section 4975 of the Internal Revenue Code
of 1986, as amended from time to time (the “
Code ”)) has occurred with respect to any
employee benefit plan which could have a Material Adverse Effect.
Each of the Company and its Subsidiary has not incurred any unpaid
liability to the Pension Benefit Guaranty Corporation (other than
for the payment of premiums in the ordinary course) or to any such
plan under Title IV of ERISA. Each “ pension
plan ” (as defined in ERISA) for which the Company
would have any liability that is intended to be qualified under
Section 401(a) of the Code is so qualified in all material respects
and nothing has occurred, whether by action or by failure to act,
which could cause the loss of such qualification.
(u)
The Company and the Subsidiary maintain insurance in such
amounts and covering such risks as the Company reasonably considers
adequate for the conduct of its business and the value of its
properties, all of which insurance is in full force and effect,
except where the failure to maintain such insurance could not
reasonably be expected to have a Material Adverse
Effect.
(v)
Each of the Company and its
Subsidiary has made all filings, applications and submissions
required by, and possesses all approvals, licenses, certificates,
certifications, clearances, consents, exemptions, marks,
notifications, orders, permits and other authorizations issued by,
the appropriate federal, state or foreign regulatory authorities
(including, without limitation, the FDA, and any other foreign,
federal, state or local government or regulatory authorities
performing functions similar to those performed by the FDA)
necessary to conduct its businesses (collectively, “
Permits ”), except for such Permits which
the failure to obtain or comply with could not reasonably be
expected to have a Material Adverse Effect, and is in compliance
with the terms and conditions of all such Permits; all of such
Permits held by each of the Company and its Subsidiary
are valid and in full force and effect
except as could not have a Material Adverse Effect; there is no
pending or threatened action, suit, claim or proceeding which may
cause any such Permit to be limited, revoked, cancelled, suspended,
modified or not renewed and each of the Company and its
Subsidiary h as not received any notice
of proceedings relating to the limitation, revocation,
cancellation, suspension, modification or non-renewal of any such
Permit which, singularly or in the aggregate, if the subject of an
unfavorable decision, ruling or finding, would have a Material
Adverse Effect, whether or not arising from transactions in the
ordinary course of business, except as set forth in or contemplated
by the Base Prospectus or the Prospectus
Supplement.
(w)
Ernst & Young LLP, who has certified certain financial
statements of the Company and delivered its report with respect to
the audited consolidated financial statements and schedules
included in the Base Prospectus, the Prospectus Supplement or the
Registration Statements, or incorporated by reference therein, as
the case may be, is an independent public accountant with respect
to the Company within the meaning of the Securities Act and the
Rules and Regulations.
(x)
Each of the Company and its Subsidiary has filed all foreign,
federal, state and local tax returns that are required to be filed
or has requested extensions thereof (except in any case in which
the failure so to file would not have a Material Adverse Effect,
except as set forth in the Base Prospectus and the Prospectus
Supplement) and has paid all taxes required to be paid by it and
any other assessment, fine or penalty levied against it, to the
extent that any of the foregoing is due and payable, except for any
such assessment, fine or penalty that is currently being contested
in good faith or as would not have a Material Adverse Effect,
except as set forth in the Base Prospectus and the Prospectus
Supplement.
(y)
The principal executive officer and principal financial
officer of the Company have made all certifications required by the
Sarbanes-Oxley Act of 2002 and the rules and regulations
promulgated in connection therewith (the “
Sarbanes-Oxley Act ”), and the statements
contained in any such certification are complete and correct. The
Company maintains “disclosure controls and procedures”
(as defined in Rule 13a-14(c) under the Exchange Act), and such
controls and procedures are designed (i) to ensure that information
required to be disclosed by the Company in the reports that it
files or submits under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the
Commission's rules and forms and (ii) to ensure that information
required to be disclosed by the Company in the reports that it
files or submits under the Exchange Act is accumulated and
communicated to the Company's management, including its principal
executive officer and principal financial officer, as appropriate
to allow timely decisions regarding required disclosure. There has
been no fraud, whether or not material, that involves management or
other employees who have a significant role in the Company's
internal controls. The Company is otherwise in compliance in all
respects with all applicable effective provisions of the
Sarbanes-Oxley Act and the rules and regulations promulgated by the
Commission (and intends to comply with all applicable provisions
that are not yet effective upon effectiveness).
(z)
Each of the Company and its Subsidiary maintains a system of
internal accounting controls sufficient to provide reasonable
assurance 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 generally accepted
accounting principles and to maintain accountability of 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 the existing
assets at reasonable intervals and appropriate action is taken with
respect to any differences.
(aa)
Each of the Company and its Subsidiary (i) is in compliance
in all material respects with any and all applicable foreign,
federal, state and local laws and regulations relating to the
protection of human health and safety, the environment or hazardous
or toxic substances or wastes, pollutants or contaminants (“
Environmental Laws ”), (ii) has received and
is in compliance with all permits, licenses or other approvals
required of it under applicable Environmental Laws to conduct its
business and (iii) has not received notice of any actual or
potential liability for the investigation or remediation of any
disposal or release of hazardous or toxic substances or wastes,
pollutants or contaminants, except where such non-compliance with
Environmental Laws, failure to receive required permits, licenses
or other approvals, or liability would not, individually or in the
aggregate, have a Material Adverse Effect, whether or not arising
from transactions in the ordinary course of business, except as set
forth in or contemplated by the Base Prospectus and the Prospectus
Supplement (exclusive of any supplement thereto). To the best of
its knowledge, the Company has not been named as a “
potentially responsible party ” under the
Comprehensive Environmental Response, Compensation, and Liability
Act of 1980, as amended.
(bb)
In the ordinary course of its business, the Company
periodically reviews the effect of Environmental Laws on the
business, operations and properties of each of the Company and its
Subsidiary, in the course of which it identifies and evaluates
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 any
permit, license or approval, any related constraints on operating
activities and any potential liabilities to third parties). On the
basis of such review, the Company has reasonably concluded that
such associated costs and liabilities would not, singularly or in
the aggregate, have a Material Adverse Effect, whether or not
arising from transactions in the ordinary course of business,
except as set forth in or contemplated by the Base Prospectus and
the Prospectus Supplement.
(cc)
Each of the Company and its Subsidiary own, possess, license
or have other rights to use all foreign and domestic patents,
patent applications, trade and service marks, trade and service
mark registrations, trade names, copyrights, licenses, inventions,
trade secrets, technology, Internet domain names, know-how and
other intellectual property (collectively, the “
Intellectual Property ”) necessary for the
conduct of the Company’s business as now conducted or as
proposed in the Base Prospectus and the Prospectus Supplement to be
conducted. Except as set forth in the Base Prospectus and the
Prospectus Supplement (a) there are no rights of third parties
to any such Intellectual Property; (b) to the Company’s
knowledge, there is no infringement by third parties of any such
Intellectual Property; (c) there is no pending or, to the
Company’s knowledge, threatened action, suit, proceeding or
claim by others challenging each of the Company’s and its
Subsidiary’s rights in or to any such Intellectual Property,
and the Company is unaware of any facts which would form a
reasonable basis for any such claim; (d) there is no pending or, to
the best of the Company’s knowledge, threatened action, suit,
proceeding or claim by others challenging the validity or scope of
any such Intellectual Property; (e) there is no pending or, to the
best of the Company’s knowledge, threatened action, suit,
proceeding or claim by others that the Company and its Subsidiary
infringe or otherwise violate any patent, trademark, copyright,
trade secret or other proprietary rights of others, and the Company
is unaware of any other fact which would form a reasonable basis
for any such claim; (f) to the Company’s knowledge, there is
no third-party U.S. patent or published U.S. patent application
which contains claims for which an Interference Proceeding could be
commenced against any patent or patent application that is
described in the Base Prospectus and the Prospectus Supplement as
being owned by or licensed the Company, except for Interference
Proceedings based on claims under any such patents or published
patent applications as could not have a Material Adverse Effect;
(g) there is no pending or, to the Company’s knowledge,
threatened action, suit, proceeding or claim by others claiming the
ownership of and interest in the Intellectual Property; and (h)
each of the Company and its Subsidiary have taken all steps
necessary to perfect its ownership of and interest in the
Intellectual Property.
(dd)
The clinical, pre-clinical and other studies and tests
conducted by or on behalf of or sponsored by the Company and its
Subsidiary were and, if still pending, are being conducted in
accordance with all material statutes, laws, rules and regulations,
as applicable (including, without limitation, those administered by
the FDA or by any foreign, federal, state or local governmental or
regulatory authority performing functions similar to those
performed by the FDA). The descriptions of the results of such
studies and tests included or incorporated by reference in the
Registration Statements, Base Prospectus and Prospectus Supplement
are accurate and complete in all material respects and fairly
present the published data derived from such studies and tests, and
the Company has no knowledge of other studies or tests the results
of which are materially inconsistent with or otherwise call into
question in any material respect the results described or referred
to in the Base Prospectus and the Prospectus Supplement. Neither
the Company nor its Subsidiary has received any notices or other
correspondence from the FDA or any other foreign, federal, state or
local governmental or regulatory authority performing functions
similar to those performed by the FDA with respect to any ongoing
clinical or pre-clinical studies or tests requiring the
termination, suspension or modification of such studies or
tests.
(ee)
Neither the Company nor its Subsidiary has failed to file
with the applicable regulatory authorities (including, without
limitation, the FDA or any foreign, federal, state or local
governmental or regulatory authority performing functions similar
to those performed by the FDA) any material filing, declaration,
listing, registration, report or submission; all such filings,
declarations, listings, registrations, reports or submissions were
in compliance with applicable laws when filed, except where the
failure to be in compliance did not, singularly or in the
aggregate, have a Material Adverse Effect, and, except as described
in the Base Prospectus and the Prospectus Supplement, the Company
has not been notified that any material deficiencies have been
asserted by any applicable regulatory authority (including, without
limitation, the FDA or any foreign, federal, state or local
governmental or regulatory authority performing functions similar
to those performed by the FDA) with respect to any such filings,
declarations, listings, registrations, reports or
submissions.
(ff)
No relationship, direct or indirect, exists between or among
the Company on the one hand and the directors, officers,
stockholders, customers or suppliers of the Company on the other
hand which is required to be described in the Base Prospectus and
the Prospectus Supplement and which is not so described.
(gg)
Neither the Company nor any other person associated with or
acting on behalf of the Company including, without limitation, any
director, officer, agent or employee of the Company or its
Subsidiary, has, directly or indirectly, while acting on behalf of
the Company or its Subsidiary (i) used any corporate funds for
unlawful contributions, gifts, entertainment or other unlawful
expenses, or received or retained any funds, relating to political
activity; (ii) made any unlawful payment from corporate funds to,
or received or retained any unlawful funds from, foreign or
domestic government officials or employees or to or from foreign or
domestic political parties or campaigns; (iii) violated any
provision of the Foreign Corrupt Practices Act of 1977, as amended;
or (iv) made any other unlawful payment or received or retained any
other unlawful funds.
(hh)
Neither the Company nor its Subsidiary is or, after giving
effect to the offering and sale of the Stock and the application of
the proceeds thereof as described in the Base Prospectus and the
Prospectus Supplement, will become an “ investment
company ” as defined in the Investment Company Act
of 1940, as amended.
(ii)
Other than as contemplated by this Agreement, neither the
Company nor its Subsidiary is a party to any contract, agreement or
understanding with any person that would give rise to a valid claim
against the Company or the Placement Agent for a brokerage
commission, finder’s fee or like payment in connection with
the offering and sale of the Stock.
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