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Exhibit 10.1
9,171,429 SHARES
HALOZYME THERAPEUTICS, INC.
SHARES OF COMMON STOCK
($0.001 PAR VALUE)
PLACEMENT AGENT AGREEMENT
December 12, 2005
SG COWEN & CO., LLC
RODMAN & RENSHAW, LLC
ROTH CAPITAL PARTNERS, LLC
c/o SG Cowen & Co., LLC
1221 Avenue of the Americas
New York, New York 10020
Dear Sirs:
Halozyme
Therapeutics, Inc., a Nevada 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 9,171,429
shares of Common Stock, $0.001 par
value (the "COMMON STOCK"), of the Company.
The aggregate of 9,171,429 shares so
proposed to be sold is hereinafter referred
to as the "STOCK." The Company
hereby confirms its agreement with the
placement agents named on Schedule I
attached hereto (the "PLACEMENT Agents"),
as set forth below. SG Cowen & Co.,
LLC is acting as the representative of the
Placement Agents and in such capacity
is hereinafter referred to as the
"REPRESENTATIVE." Certain terms used herein
are defined in Section 14 hereof.
1. AGREEMENT TO ACT AS PLACEMENT AGENTS;
PLACEMENT OF SECURITIES. On the basis
of the representations, warranties and
agreements of the Company and its
Subsidiary (as defined below) herein
contained, and subject to all the terms and
conditions of this Agreement:
(a) The Company hereby authorizes the Placement Agents to act as
its
exclusive agents 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 Closing Date (as defined
in
Section 3 hereof), the Company shall not, without the prior consent
of
the Representative, solicit or accept offers to purchase the
Stock
otherwise than through the Placement Agents.
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(b) The Placement Agents agree, as agents of the Company, to use
their
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 Agents 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 Agents and accepted by the Company, but the Placement
Agents
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
Agents be obligated to purchase any Stock for its own account and,
in
soliciting purchases of Stock, the Placement Agents shall act
solely as
the Company's agent and not as principals. Notwithstanding the
foregoing and except as otherwise provided in Section 1(c), it
is
understood and agreed that the Placement Agents (or their
affiliates)
may, solely at their discretion and without any obligation to do
so,
purchase Stock as principals.
(c) Subject to the provisions of this Section 1, offers for the
purchase of Stock may be solicited by the Placement Agents as
agents
for the Company at such times and in such amounts as the
Placement
Agents deem advisable. Each 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 to accept offers to purchase the Stock and may reject any
such
offer, in whole or in part. Each Placement Agent shall have the
right,
in its discretion reasonably exercised, without 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 Agents by wire transfer of
immediately available funds to an account or accounts designated by
the
Representative, an amount equal to seven percent (7%) 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
whose
offer it has accepted, the Company shall indemnify and hold the
Placement Agents harmless against any loss, claim or damage
arising
from or as a result of such default by the Company.
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2. REPRESENTATIONS AND WARRANTIES OF THE
COMPANY AND ITS SUBSIDIARY. The Company
and its Subsidiary represent and warrant
to, and agrees with, the several
Placement Agents 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.
333-125731),
which became effective as of June 17, 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 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 Representative 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,
including all exhibits thereto (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
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preliminary prospectus, if any, together with the free writing
prospectuses, if any, used in connection with the Offering,
including
any documents, incorporated by reference therein.
(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 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 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 any 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 Agents' 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
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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 Representative's consent, prepare, use or refer to,
any
free writing prospectus.
(d) The Company has delivered, or will as promptly as
practicable
deliver, to the Representative 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
Representative 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 Halozyme, 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
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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. There are no authorized or
outstanding
options, warrants, preemptive rights, rights of first refusal or
other
rights to
purchase, or equity or debt securities convertible into or
exchangeable or exercisable for, any capital stock of the Company
that
have been granted by the Company other than: (i) those
accurately
described in the Base Prospectus or ii) those issued pursuant
to
existing stock option plans. 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
non-assessable 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 limited by applicable bankruptcy,
insolvency,
reorganization, moratorium or similar laws affecting creditors'
and
contracting parties' 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)
and
except as the indemnification agreements of the Company herein may
be
legally unenforceable.
(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
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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, except any such conflicts, breaches or violations which
would
not reasonably be expected to have a Material Adverse Effect, nor
will
such actions result in any violation of the provisions of the
charter
or bylaws of the Company or its Subsidiary or 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.
(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,
except as
redacted pursuant to confidential treatment requests. 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 its Subsidiary or any of
the
other parties thereto, neither the Company or its Subsidiary has
sent
or received any communication regarding intent not to renew any
such
franchise, contract, lease, instrument or other document, and
neither
the Company nor its Subsidiary has 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, Nominating and
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 Agents and
counsel
for the Placement Agents. 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 or its Subsidiary 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
(or
will be timely obtained or made) under the Securities Act or
the
Exchange Act and 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.
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(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 from the Company 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 had their shares already registered under
the
Securities Act, 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 180 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 or the Registration Statement, 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; provided, however, that statements that are unaudited
are
subject to year-end adjustments and do not contain notes required
under
generally accepted accounting principles. 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
Statement,
the Time of Sale Prospectus, if any, or incorporated by
reference
therein, as the case may be.
(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, might have a Material Adverse
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Effect or would prevent or adversely affect the ability of the
Company
or its Subsidiary to perform its obligations under this Agreement;
and
to the best of the Company's knowledge, 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 and the Prospectus Supplement and
the
Time of Sale Prospectus, if any as being owned by the Company or
its
Subsidiary, free and clear of any 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 Time of Sale Prospectus, if any,
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.
(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
or
its Subsidiary, or any of their 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 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
or
its Subsidiary exists or, to the Company's knowledge, is threatened
or
imminent, which might be expected to have a Material Adverse
Effect.
Neither the Company nor its Subsidiary is aware that any key
employee
of the Company or its Subsidiary or significant group of employees
of
the Company or its
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Subsidiary plans to terminate employment with the Company or
its
Subsidiary.
(u) 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 or its Subsidiary 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 and its Subsidiary maintain insurance in such
amounts
and covering such risks as is adequate for the conduct of its
business
and the value of its properties and as is customary for
companies
engaged in similar businesses in similar industries; all such
insurance
is fully in force on the date hereof and will be fully in force on
the
Closing Date.
(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 business as presently conducted
(collectively,
"PERMITS"), except for such Permits which the failure to obtain
would
not 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;
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
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<PAGE>
transactions in the ordinary course of business, except as set
forth in
or contemplated
by the Base Prospectus.
(x) Cacciamatta Accountancy Corp., who have certified certain
financial
statements of the Company and delivered their report with respect
to
the audited consolidated financial statements and schedules
included in
the Base Prospectus, the Prospectus Supplement or the
Registration
Statement, or incorporated by reference therein, as the case may
be,
are independent registered public accountants 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. The Company
does
not have any material weaknesses in internal controls, and to
the
Company's knowledge there has been no fraud, whether or not
material,
that involves management or other employees of the Company or
its
Subsidiary 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) 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
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<PAGE>
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. Except
as
described in the Base Prospectus, since the end of the Company's
most
recent fiscal year, there has been no change in the Company's or
its
Subsidiary's internal control over financial reporting that has
materially affected, or is reasonably likely to materially affect,
the
Company's internal control over financial reporting.
(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). Neither the Company nor its Subsidiary has been named as
a
"POTENTIALLY RESPONSIBLE PARTY" under the Comprehensive
Environmental
Response, Compensation, and Liability Act of 1980, as amended.
(cc) There has been no storage, disposal, generation,
manufacture,
refinement, transportation, handling or treatment of medical
wastes,
toxic wastes, hazardous wastes or hazardous substances by the
Company
or its Subsidiary (or, to the Company's knowledge, any of the
Company's
or its Subsidiary's predecessors in interest) at, upon or from any
of
the property now or previously owned or leased by the Company or
its
Subsidiary in violation of any applicable Environmental Law which
would
require remedial action under any applicable Environmental Law,
except
for any violation or remedial action which would not cause,
singularly
or in the aggregate with all such violations and remedial actions,
a
Material Adverse Effect; there has been no material spill,
discharge,
leak, emission, injection, escape, dumping or release of any kind
onto
such property or of any medical wastes, toxic wastes, hazardous
wastes
or hazardous substances due to or caused by the Company or its
Subsidiary or with respect to which the Company or its Subsidiary
had
knowledge, except for any such spill, discharge, leak,
emission,
injection, escapes, dumpings or releases which would not cause or
would
not be reasonably likely to cause, singularly or in the aggregate
with
all such spills, discharges, leaks, emissions, injections,
escapes,
dumpings or releases, a Material Adverse Effect; and the terms
"hazardous substances," "toxic wastes," "hazardous wastes" and
"medical
wastes" shall have the meanings specified in any applicable
Environmental Laws.
12
<PAGE>
(dd) In the ordinary course of its business, the Company and
its
Subsidiary 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 and its Subsidiary 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.
(ee) Each of the Company and its Subsidiary owns, possesses,
licenses
or has 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 Prospectus Supplement and
the
Time of Sale Prospectus, if any, 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 best of the Company's
knowledge,
there is no infringement by third parties of any such
Intellectual
Property; (c) there is no pending or, to the best of the
Company's
knowledge, threatened action, suit, proceeding or claim by
others
challenging each of the Company's and the Subsidiary's rights in or
to
any such Intellectual Property, and neither the Company nor its
Subsidiary 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 or its Subsidiary infringe or otherwise violate any
patent,
trademark, copyright, trade secret or other proprietary rights
of
others, and neither the Company nor its Subsidiary 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 part of the Intellectual Property; (g) there is
no
pending or, to the best of the Company's knowledge, threatened
action,
suit, proceeding or claim by others claiming the ownership of
and
interest in the Intellectual Property; and (h) to the best of
the
Company's knowledge, the Company and its Subsidiary have taken
all
steps necessary to perfect its ownership of and interest in the
Intellectual Property.
(ff) The clinical, pre-clinical and other studies and tests
conducted
by or on behalf of or sponsored by the Company or its Subsidiary
that
are described or referred to in the Base Prospectus or
Prospectus
Supplement were and, if still pending, are being conducted in
accordance with all statutes, laws, rules and
13
<PAGE>
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 that are described or referred to in the Base
Prospectus or Prospectus Supplement are accurate and complete in
all
material respects and fairly present the published data derived
from
such studies and tests, and each of the Company and its Subsidiary
has
