Exhibit
10.1
Execution Copy
450,000 Shares
DISCOVERY LABORATORIES, INC.
Shares of Common Stock
($0.001 par value)
PLACEMENT AGENT AGREEMENT
February 18, 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
450,000 shares of Common Stock, par value $0.001 per share (the
“ Common Stock ”), of the Company. The
aggregate of 450,000 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 February 17, 2005, the Company had cash and marketable
securities as set forth in that certain representation letter,
dated February 17, 2005, 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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