Exhibit 10.2
3,030,304
Shares
DISCOVERY LABORATORIES,
INC.
Shares of Common
Stock
($0.001 par
value)
PLACEMENT AGENT
AGREEMENT
December 13, 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 3,030,304 shares of Common Stock, par
value $0.001 per share (the “ Common Stock
”), of the Company. The aggregate of 3,030,304 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 14 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 four and three quarters percent (4 3/4%) 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.
(g)
The Placement Agent agrees to
furnish the Company with a copy of each proposed free writing
prospectus prepared by or on behalf of the Placement Agent before
its first use and shall not use any free writing prospectus without
the Company’s prior written consent (which shall not be
unreasonably withheld).
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. 333-128929), which became
effective as of October 24, 2005, for the registration under the
Securities Act of the Stock. Such 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 (the “
Rules and Regulations ”) of the Commission
promulgated thereunder, a supplement to the form of prospectus
included in such 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 registration statement, including the exhibits
thereto, as amended at the date of this Agreement, is hereinafter
called the “ Registration Statement ”;
such prospectus in the form in which it appears in the 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 the “
Prospectus Supplement .” Any reference
herein to the Registration Statement, 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
Statement, 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 Statement,
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
Statement, the Base Prospectus or the Prospectus Supplement, as the
case may be. No stop order suspending the effectiveness of the
Registration Statement 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. For purposes of this
Agreement, “ free writing prospectus ”
has the meaning set forth in Rule 405 under the Securities Act and
the “ Time of Sale Prospectus ” means
the Base Prospectus, together with the free writing prospectuses,
if any, used in connection with the Offering, including any
documents incorporated by reference therein. All references in this
Agreement to the Registration Statement, a Base Prospectus, the
Time of Sale 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 Statement (and any
further documents to be filed with the Commission) contains all
exhibits and schedules as required by the Securities Act. Each of
the 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, the Time of Sale Prospectus, if
any, 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, the Time of Sale Prospectus, if any, 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, the Time of
Sale Prospectus, if any, 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 Time of Sale Prospectus, if any, or 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 Statement, the Time of
Sale Prospectus, if any, or the Prospectus Supplement, which
information the parties hereto agree is limited to the Placement
Agent’s Information as defined in Section 16 . No
post-effective amendment to the Registration Statement 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, the Time of Sale Prospectus, if any, or
Prospectus Supplement, or to be filed as exhibits or schedules to
the Registration Statement, which have not been described or filed
as required.
(c)
The Company is eligible to use free
writing prospectuses in connection with the Offering pursuant to
Rules 164 and 433 under the Securities Act. Any free writing
prospectus that the Company is required to file pursuant to Rule
433(d) under the Securities Act has been, or will be, filed with
the Commission in accordance with the requirements of the
Securities Act and the applicable rules and regulations of the
Commission thereunder. Each free writing prospectus that the
Company has filed, or is required to file, pursuant to Rule 433(d)
under the Securities Act or that was prepared by or behalf of or
used by the Company complies or will comply in all material
respects with the requirements of the Securities Act and the
applicable rules and regulations of the Commission thereunder. The
Company will not, without the Placement Agent’s consent,
prepare, use or refer to, any free writing prospectus related to
the Offering.
(d)
The Company has delivered, or will
as promptly as practicable deliver, to the Placement Agent complete
conformed copies of the Registration Statement and of each consent
and certificate of experts filed as a part thereof, and conformed
copies of the Registration Statement (without exhibits) and the
Base Prospectus, the Time of Sale Prospectus, if any, 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 Time of Sale Prospectus, if any, the
Prospectus Supplement, the Registration Statement, copies of the
documents incorporated by reference therein and any other materials
permitted by the Securities Act.
(e)
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 ”).
(f)
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, the Prospectus Supplement
and the Time of Sale Prospectus, if any.
(g)
The Company has an authorized
capitalization as set forth in the Base Prospectus, the Prospectus
Supplement and the Time of Sale Prospectus, if any, 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, the Prospectus Supplement and the
Time of Sale Prospectus, if any. 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. 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 completely, accurately and fairly present the
information required to be shown with respect to such plans,
arrangements, options and rights.
(h)
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, 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
”).
(i)
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).
(j)
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.
(k)
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 or the Prospectus Supplement, or to be filed as an
exhibit to the Registration Statement, 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 Statement are accurate
and complete in all material respects. Other than as described in
the Base Prospectus, 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.
(l)
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.
(m)
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 filing with The Nasdaq Stock Market (“
Nasdaq ”) of a Notification Form: Listing of
Additional Shares.
(n)
Except as described in the Base
Prospectus, (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 Statement 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 Statement or the offering contemplated thereby,
whether as a result of the filing or effectiveness of the
Registration Statement 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.
(o)
The financial statements, together
with the related notes and schedules, of the Company included in
the Base Prospectus, the Prospectus Supplement, the Registration
Statement or the Time of Sale Prospectus, if any, 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, the Registration Statement or the Time of
Sale Prospectus, if any, or incorporated by reference therein, as
the case may be. As of November 30, 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.
(p)
Except as set forth in the Base
Prospectus, 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 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, no such proceedings are
threatened or contemplated by governmental authorities or
threatened by others.
(q)
The Company and its Subsidiary have
good and marketable title to all property (real and personal)
described in the Registration Statement, the Base Prospectus, the
Prospectus Supplement and the Time of Sale Prospectus, if any, 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 Statement, the Base
Prospectus, the Prospectus Supplement and the Time of Sale
Prospectus, if any, 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.
(r)
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.
(s)
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 16, 2005 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.
(t)
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 plans
to terminate employment with the Company.
(u)
The Company 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 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. The Company 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.
(v)
The Company maintains 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.
(w)
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 has 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.
(x)
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, the Time of Sale Prospectus, if any, or the
Registration Statement, 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.
(y)
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 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.
(z)
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).
(aa)
The Company 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.
(bb)
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 (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.
(cc)
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.
(dd)
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, the Time of
Sale Prospectus, if any, or the Prospectus Supplement, to be
conducted. Except as set forth in the Base Prospectus
(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, the Ti
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