Exhibit 1.1
JAVELIN PHARMACEUTICALS, INC.
PLACEMENT AGENCY AGREEMENT
May 8,
2008
Leerink
Swann LLC
Riverbank Capital Securities, Inc.
c/o Leerink Swann LLC
One Federal Street
Boston, MA 02110
Ladies
and Gentlemen:
1. Introductory
. Javelin Pharmaceuticals, Inc., a Delaware corporation (the
“ Company ”), proposes, pursuant to the terms of
this Placement Agency 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 ”), to sell to the Purchasers
up to an aggregate of 11,423,107 shares (the “
Shares ”) of common stock, par value $0.001 per share
(the “ Common Stock ”) of the Company. The
Company hereby confirms its agreement with Leerink Swann LLC
(“ Leerink ”), to act as lead placement agent
and with Riverbank Capital Securities, Inc. (“
Riverbank ”) to act as co-placement agent (Leerink and
Riverbank, the “ Placement Agents ”) in
accordance with the terms and conditions hereof as set forth
below.
2. Agreement to Act as
Placement Agents; Placement of Shares . 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 engages the Placement
Agents to act as its exclusive agents, on a best efforts basis, in
connection with the issuance and sale by the Company of the Shares
(the “ Offering ”). Until the Closing Date
(defined below), the Company shall not, without the prior consent
of Leerink, solicit or accept offers to purchase Shares otherwise
than through the Placement Agents.
(b) Under no circumstances will the
Placement Agents be obligated to purchase any Shares for their own
account and, in soliciting purchases of Shares, the Placement
Agents shall act solely as the Company’s agents and not as
principals.
(c) Subject to the provisions of this
Section 2, offers for the purchase of Shares 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. The
Placement Agents shall communicate to the Company, orally or in
writing, each reasonable offer to purchase Shares received by it as
agents of the Company. The Company shall have the sole right to
accept offers to purchase the Shares and may reject any such offer,
in whole or in part. The Placement Agents shall have the right, in
their discretion reasonably exercised, with notice to the Company,
to reject any offer to purchase Shares received by it, in whole or
in part, and any such rejection shall not be deemed a breach of
their agreement contained herein.
(d) The purchases of the Shares by
the Purchasers shall be evidenced by the execution of Subscription
Agreements by each of the parties thereto.
(e) As full 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 Placement Agents, an
aggregate amount equal to 6% of the gross proceeds received by the
Company from the sale of the Shares on the Closing Date (the
“ Placement Fee ”) (such aggregate amount to be
divided among the Placement Agents as set forth in the Engagement
Letter) pursuant to and in accordance with Section 3 of that
certain engagement letter by and among the Company and the
Placement Agents dated as of April 24, 2008, as amended to
date (the “ Engagement Letter ”). In no event
will the Placement Fee, together with reimbursable expenses of the
Placement Agents described in the Engagement Letter, exceed 8.0% of
the maximum gross proceeds of the Offering. At the Closing, the
Company shall direct the Escrow Agent (defined below) to wire to an
account or accounts designated by the Placement Agents such amounts
out of the Escrow Funds (defined below).
(f) No Shares that 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
Shares shall have been delivered to the Purchaser thereof against
payment by such Purchaser. If the Company shall default in its
obligations to deliver Shares 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.
3. Delivery and
Payment.
(a) Concurrently with the execution
and delivery of this Agreement, the Company, the Placement Agents
and JPMorgan Chase Bank, N.A., as escrow agent (the “
Escrow Agent ”), shall enter into an escrow agreement
(the “Escrow Agreement”), pursuant to which an escrow
account (the “ Escrow Account ”) will be
established for the benefit of the Company and the Purchasers.
Prior to the completion of the purchase and sale of the Shares
pursuant to this Agreement and the Subscription Agreements (the
“ Closing ”), each such Purchaser shall deposit
into the Escrow Account an amount equal to the product of
(x) the number of Shares such Purchaser has agreed to purchase
and (y) the purchase price per Share as set forth in the
Subscription Agreements (the “ Purchase Amount
”). The aggregate of such Purchase Amounts is herein referred
to as the “ Escrow Funds .” On the Closing Date,
upon satisfaction or waiver of all of the conditions to Closing,
the Escrow Agent will disburse the Escrow Funds to the Company and
the Placement Agents as provided in the Escrow Agreement and
Section 2(e) above, and the Company shall cause the Shares to be
delivered to the Purchasers.
(b) Subject to the terms and
conditions hereof, delivery of the Shares shall be made by the
Company to the Purchasers, and payment of the purchase price shall
be made by the Purchasers, at the office of Goodwin Procter LLP, 53
State Street, Boston, Massachusetts 02109 (or at such other place
as agreed upon by the Placement Agents and the Company), at
10:00 a.m., New York City time, on or before May [___], 2008
or at such time on such other date as may be agreed upon in writing
by the Company and Leerink but in no event prior to the date on
which the Escrow Agent shall have received all of the Escrow Funds
(such date of delivery and payment is hereinafter referred to as
the “ Closing Date ”). The Shares shall be
delivered, through the facilities of The Depository Trust Company,
to such persons, and shall be registered in such name or names and
shall be in such denominations, as the Placement Agents may request
by written notice to the Company at least one business day before
the Closing Date. The cost of original issue tax stamps and other
transfer taxes, if any, in connection with the issuance and
delivery of the Shares by the Company to the respective Purchasers
shall be borne by the Company.
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4. Representations and
Warranties of the Company. The Company represents and
warrants to, and agrees with, the Placement Agents that:
(a)
Filing and Effectiveness of Registration Statement; Certain
Defined Terms . The Company has filed with the Commission a
registration statement on Form S-3 (No. 333- 149090),
including a related prospectus or prospectuses, covering the
registration of the Shares under the Act, which registration
statement has become effective. “ Registration
Statement ” at any particular time means such
registration statement in the form then filed with the Commission,
including any amendment thereto, any document incorporated by
reference therein and all 430B Information or all 430C Information
with respect to such registration statement, that in any case has
not been superseded or modified. “Registration
Statement” without reference to a time means the Registration
Statement as of the Effective Date. For purposes of this
definition, 430B Information shall be considered to be included in
the Registration Statement as of the time specified in
Rule 430B.
For purposes of this Agreement:
“ 430B Information
” means information included in a prospectus then deemed to
be a part of the Registration Statement pursuant to
Rule 430B(e) or retroactively deemed to be a part of the
Registration Statement pursuant to Rule 430B(f).
“ 430C Information
” means information included in a prospectus then deemed to
be a part of the Registration Statement pursuant to
Rule 430C.
“ Act ” means the
Securities Act of 1933, as amended.
“ Applicable Time
” means [5:00 p.m.] (Eastern time) on the date of this
Agreement.
“ Closing Date ”
has the meaning defined in Section 3 hereof.
“ Commission ”
means the Securities and Exchange Commission.
“ Effective Date ”
of the Registration Statement relating to the Shares means the
earlier of (a) first use of the Final Prospectus and
(b) the time of the first contract of sale for the
Shares.
“ Exchange Act ”
means the Securities Exchange Act of 1934, as amended.
“ Final Prospectus
” means the Statutory Prospectus that discloses the public
offering price, other 430B Information and other final terms of the
Shares and otherwise satisfies Section 10(a) of the Act.
“ General Use Issuer Free
Writing Prospectus ” means any Issuer Free Writing
Prospectus that is intended for general distribution to prospective
investors, as evidenced by its being so specified in
Schedule A to this Agreement.
“ Issuer Free Writing
Prospectus ” means any “issuer free writing
prospectus,” as defined in Rule 433, relating to the
Shares in the form filed or required to be filed with the
Commission or, if not required to be filed, in the form retained in
the Company’s records pursuant to Rule 433(g).
“ Limited Use Issuer Free
Writing Prospectus ” means any Issuer Free Writing
Prospectus that is not a General Use Issuer Free Writing
Prospectus.
“ Rules and Regulations
” means the rules and regulations of the Commission.
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“ Securities Laws
” means, collectively, the Sarbanes-Oxley Act of 2002
(“ Sarbanes-Oxley ”), the Act, the Exchange Act,
the Rules and Regulations, the auditing principles, rules,
standards and practices applicable to auditors of
“issuers” (as defined in Sarbanes-Oxley) promulgated or
approved by the Public Company Accounting Oversight Board and the
rules of the American Stock Exchange.
“ Statutory Prospectus
” with reference to any particular time means the prospectus
relating to the Shares that is included in the Registration
Statement immediately prior to that time, including any document
incorporated by reference therein and all 430B Information and all
430C Information with respect to the Registration Statement. For
purposes of the foregoing definition, 430B Information shall be
considered to be included in the Statutory Prospectus only as of
the actual time that form of prospectus (including a prospectus
supplement) is filed with the Commission pursuant to Rule 424(b)
and not retroactively.
Unless otherwise specified, a
reference to a “ rule ” is to the indicated rule
under the Act.
(b)
Compliance with Securities Act Requirements. (i)
(A) At the time the Registration Statement initially became
effective, (B) at the time of each amendment thereto for the
purposes of complying with Section 10(a)(3) of the Act
(whether by post-effective amendment, incorporated report or form
of prospectus), (C) on the Effective Date relating to the
Shares and (D) on the Closing Date, the Registration Statement
conformed and will conform in all material respects to the
requirements of the Act and the Rules and Regulations and did not
and will not include any untrue statement of a material fact or
omit to state any material fact required to be stated therein or
necessary to make the statements therein not misleading and (ii)
(A) on its date, (B) at the time of filing the Final
Prospectus pursuant to Rule 424(b) and (C) on the Closing
Date, the Final Prospectus will conform in all material respects to
the requirements of the Act and the Rules and Regulations, and will
not include any untrue statement of a material fact or omit to
state any material fact necessary in order to make the statements
therein, in the light of the circumstances under which they were
made, not misleading. The preceding sentence does not apply to
statements in or omissions from any such document based upon
written information furnished to the Company by the Placement
Agents, if any, specifically for use therein, it being understood
and agreed that the only such information is that described as such
in Section 8(b) hereof.
(c)
Effectiveness. No stop order of the Commission
preventing or suspending the use of any Statutory Prospectus, the
Final Prospectus Supplement, or any Free Writing Prospectus, or the
effectiveness of the Registration Statement, has been issued, and
no proceedings for such purpose have been instituted or, to the
Company’s knowledge, are contemplated by the
Commission.
(d)
Shelf Registration Statement. The date of this
Agreement is not more than three years subsequent to the more
recent of the initial effective date of the Registration Statement
or February 12, 2008.
(e)
General Disclosure Package. As of the Applicable
Time, neither (i) the General Use Issuer Free Writing
Prospectus(es) issued at or prior to the Applicable Time, together
with the accompanying prospectus (which is the most recent
Statutory Prospectus distributed to investors generally) and any
other documents listed or disclosures stated in
Schedule A to this Agreement to be included in the
General Disclosure Package, all considered together (collectively,
the “ General Disclosure Package ”), nor
(ii) any individual Limited Use Issuer Free Writing
Prospectus, when considered together with the General Disclosure
Package, included any untrue statement of a material fact or
omitted to state any material fact necessary in order to make the
statements therein, in the light of the circumstances under which
they were made, not misleading. The preceding sentence does not
apply to statements in or omissions from any Statutory Prospectus
or any Issuer Free Writing Prospectus in reliance upon and in
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conformity with written information furnished to the Company by the
Placement Agents specifically for use therein, it being understood
and agreed that the only such information furnished by the
Placement Agents consists of the information described as such in
Section 8(b) hereof.
(f)
Issuer Free Writing Prospectuses. Each Issuer Free
Writing Prospectus, as of its issue date and at all subsequent
times through the completion of the public offer and sale of the
Shares or until any earlier date that the Company notified or
notifies the Placement Agents as described in the next sentence,
did not, does not and will not include any information that
conflicted, conflicts or will conflict with the information then
contained in the Registration Statement. If at any time following
issuance of an Issuer Free Writing Prospectus there occurred or
occurs an event or development as a result of which such Issuer
Free Writing Prospectus conflicted or would conflict with the
information then contained in the Registration Statement or as a
result of which such Issuer Free Writing Prospectus, if republished
immediately following such event or development, would include an
untrue statement of a material fact or omitted or would omit to
state a material fact necessary in order to make the statements
therein, in the light of the circumstances under which they were
made, not misleading, (i) the Company has promptly notified or
will promptly notify the Placement Agents and (ii) the Company
has promptly amended or will promptly amend or supplement such
Issuer Free Writing Prospectus to eliminate or correct such
conflict, untrue statement or omission. The foregoing two sentences
do not apply to statements in or omissions from any Issuer Free
Writing Prospectus in reliance upon and in conformity with written
information furnished to the Company by the Placement Agents
specifically for use therein, it being understood and agreed that
the only such information furnished by the Placement Agents
consists of the information described as such in Section 8(b)
hereof.
(g)
Incorporated Documents . The documents
incorporated by reference in the Registration Statement and the
General Disclosure Package and the Final Prospectus, when they
became effective or were filed with the Commission, as the case may
be, conformed in all material respects to the requirements of the
Securities Act and the Exchange Act, as applicable and none of such
documents contained any untrue statement of a material fact or
omitted to state a material fact required to be stated therein or
necessary to make the statements therein, in the light of the
circumstances under which they were made, not misleading; and any
further documents so filed and incorporated by reference in the
Registration Statement and the General Disclosure Package and the
Final Prospectus, when such documents become effective or are filed
with the Commission, as the case may be, will conform in all
material respects to the requirements of the Act or the Exchange
Act, as applicable, and 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, in the
light of the circumstances under which they were made, not
misleading.
(h)
Financial Statements . The financial
statements and the notes related thereto or incorporated by
reference in the Registration Statement and the General Disclosure
Package and the Final Prospectus present fairly the financial
condition of the Company and its consolidated subsidiaries as of
the respective dates thereof and the results of operations and cash
flows of the Company and its consolidated subsidiaries for the
respective periods covered thereby, all in conformity with
generally accepted accounting principles applied on a consistent
basis throughout the entire period involved, except where and to
the extent noted. McGladrey & Pullen, LLP (“
Accountants ”), who have reported on such financial
statements and schedules, are independent accountants with respect
to the Company as required by the Act and the Rules and Regulations
and Rule 3600T of the Public Company Accounting Oversight
Board (“ PCAOB ”). The summary and selected
consolidated financial and statistical data included in or
incorporated by reference into the Registration Statement present
fairly the information shown therein and have been derived on a
basis consistent with the audited financial statements presented in
the Registration Statement.
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(i)
No Material Adverse Change . Since the date of
the most recent financial statements of the Company included or
incorporated by reference in the Registration Statement and the
General Disclosure Package and the Final Prospectus,
(i) except for the issuance of options under option plans of
the Company described therein or shares issued upon the exercise of
such options or other convertible securities there has not been any
change in the capital stock or long-term debt of the Company or any
of its subsidiaries, or any dividend or distribution of any kind
declared, set aside for payment, paid or made by the Company on any
class of capital stock, or any material adverse change, or any
development involving a prospective material adverse change, in or
affecting the business, properties, management, financial position,
stockholders’ equity, results of operations or prospects of
the Company and its subsidiaries taken as a whole;
(ii) neither the Company nor any of its subsidiaries has
entered into any transaction or agreement, other than in the
ordinary course of business that is material to the Company and its
subsidiaries taken as a whole or incurred any liability or
obligation, direct or contingent, that is material to the Company
and its subsidiaries taken as a whole; and (iii) neither the
Company nor any of its subsidiaries has sustained any material loss
or interference with its business from fire, explosion, flood or
other calamity, whether or not covered by insurance, or from any
labor disturbance or dispute or any action, order or decree of any
court or arbitrator or governmental or regulatory authority, except
in each case as otherwise disclosed in the Registration Statement
and the General Disclosure Package and the Final Prospectus.
(j)
Organization and Good Standing . The Company
and each of its subsidiaries have been duly organized and are
validly existing and in good standing under the laws of their
respective jurisdictions of organization, are duly qualified to do
business and are in good standing 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 corporate 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 or have
such power or authority would not, individually or in the
aggregate, have a material adverse effect on the business,
properties, management, financial position, stockholders’
equity, results of operations or prospects of the Company and its
Subsidiaries taken as a whole (a “ Material Adverse
Effect ”). The Company does not own or control, directly
or indirectly, any corporation, association or other entity other
than the subsidiaries listed in Exhibit 21.1 to the
Company’s annual report on Form 10-K for the fiscal year
ended December 31, 2007.
(k)
Capitalization . The Company has an authorized
capitalization as set forth in the Registration Statement and the
General Disclosure Package and the Final Prospectus under the
heading “Capitalization”(except for subsequent
issuances, if any, pursuant to this Agreement, pursuant to
reservations, agreements or employee benefit plans referred to in
the Final Prospectus or pursuant to the exercise of convertible
securities or options referred to in the Final Prospectus); all the
outstanding shares of capital stock of the Company have been duly
and validly authorized and issued and are fully paid and
non-assessable and are not subject to any pre-emptive or similar
rights; except as described in or expressly contemplated by the
General Disclosure Package and the Final Prospectus, there are no
outstanding rights (including, without limitation, pre-emptive
rights), warrants or options to acquire, or instruments convertible
into or exchangeable for, any shares of capital stock or other
equity interest in the Company or any of its subsidiaries, or any
contract, commitment, agreement, understanding or arrangement of
any kind relating to the issuance of any capital stock of the
Company or any such subsidiary, any such convertible or
exchangeable securities or any such rights, warrants or options;
the capital stock of the Company conforms in all material respects
to the description thereof contained in the Registration Statement
and the General Disclosure Package and the Final Prospectus; and
all the outstanding shares of capital stock or other equity
interests of each subsidiary of the Company have been duly and
validly authorized and issued, are fully paid and non-assessable
and are owned directly or indirectly by the Company, free and clear
of any lien, charge, encumbrance, security interest, restriction on
voting or transfer or any other claim of any third party.
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(l)
Due Authorization . The Company has full
right, power and authority to execute and deliver this Agreement
and to perform its obligations hereunder; and all action required
to be taken for the due and proper authorization, execution and
delivery by it of this Agreement and the consummation by it of the
transactions contemplated hereby has been duly and validly
taken.
(m)
Placement Agency Agreement . This Agreement
has been duly authorized, executed and delivered by the
Company.
(n)
The Shares . The Shares have been duly
authorized by the Company and, when issued and delivered and paid
for as provided herein, will be duly and validly issued and will be
fully paid and nonassessable and will conform to the descriptions
thereof in the General Disclosure Package and the Final Prospectus;
and the issuance of the Shares is not in violation of any
preemptive or similar rights.
(o)
Description of Placement Agency Agreement .
This Agreement conforms in all material respects to the description
thereof contained in the Registration Statement and the General
Disclosure Package and the Final Prospectus.
(p)
No Violation or Default . Neither the Company
nor any of its subsidiaries is (i) in violation of its charter
or by-laws or other organizational documents; (ii) in default,
and no event has occurred that, with notice or lapse of time or
both, would constitute such a default, in the due performance or
observance of any term, covenant or condition contained in any
indenture, mortgage, deed of trust, loan agreement or other
agreement or instrument to which the Company or any of its
subsidiaries is a party or by which the Company or any of its
subsidiaries is bound or to which any of the property or assets of
the Company or any of its subsidiaries is subject; or (iii) in
violation of any law or statute or any judgment, order, rule or
regulation of any court or arbitrator or governmental or regulatory
authority, except, in the case of clauses (ii) and (iii)
above, for any such default or violation that would not,
individually or in the aggregate, have a Material Adverse
Effect.
(q)
No Conflicts . The execution, delivery and
performance by the Company of this Agreement, the issuance and sale
of the Shares and the consummation of the transactions contemplated
by this Agreement will not (i) conflict with or result in a
breach or violation of any of the terms or provisions of, or
constitute a default under, or result in the creation or imposition
of any lien, charge or encumbrance upon any property or assets of
the Company or any of its subsidiaries pursuant to, any indenture,
mortgage, deed of trust, loan agreement or other agreement or
instrument to which the Company or any of its subsidiaries is a
party or by which the Company or any of its subsidiaries is bound
or to which any of the property or assets of the Company or any of
its subsidiaries is subject, (ii) result in any violation of
the provisions of the charter or by-laws of the Company or any of
its subsidiaries or (iii) result in the violation of any law
or statute or any judgment, order, rule or regulation of any court
or arbitrator or governmental or regulatory authority having
jurisdiction over the Company or any of its subsidiaries, except,
in the case of clauses (i) and (iii) above, for any such
conflict, breach, violation, default, lien, charge or encumbrance
that would not, individually or in the aggregate, have a Material
Adverse Effect.
(r)
No Consents Required . No consent, approval,
authorization, order, registration or qualification of or with any
court or arbitrator or governmental or regulatory authority is
required for the execution, delivery and performance by the Company
of this Agreement, the issuance and sale of the Shares and the
consummation of the transactions contemplated by this Agreement,
except for the registration of the Shares under the Securities Act
and such consents, approvals, authorizations, orders and
registrations or qualifications as may be required under applicable
state securities laws or applicable rules and regulations of the
American Stock Exchange in connection with the purchase and
distribution of the Shares by the Placement Agents.
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(s)
Legal Proceedings . Except as described in the
Registration Statement and the General Disclosure Package and the
Final Prospectus, there are no legal, governmental or regulatory
investigations, actions, suits or proceedings pending to which the
Company or any of its subsidiaries is or may be a party or to which
any property of the Company or any of its subsidiaries is or may be
the subject that, individually or in the aggregate, if determined
adversely to the Company or any of its subsidiaries, could
reasonably be expected to have a Material Adverse Effect or
materially and adversely affect the ability of the Company to
perform its obligations under this Agreement; no such
investigations, actions, suits or proceedings are, to the knowledge
of the Company, threatened by any governmental or regulatory
authority or threatened by others; and (i) there are no
current or pending legal, governmental or regulatory actions, suits
or proceedings that are required under the Securities Act to be
described in the Registration Statement that are not so described
in the Registration Statement and the General Disclosure Package
and the Final Prospectus and (ii) there are no contracts or
other documents that are required under the Securities Act to be
filed as exhibits to the Registration Statement or described in the
Registration Statement and the General Disclosure Package and the
Final Prospectus that are not so filed as exhibits to the
Registration Statement or described in the Registration Statement
and the General Disclosure Package and the Final Prospectus.
(t)
Independent Accountants . McGladrey &
Pullen, LLP, who have certified certain financial statements of the
Company and its subsidiaries is an independent registered public
accounting firm with respect to the Company and its subsidiaries
within the applicable rules and regulations adopted by the
Commission and the Public Accounting Oversight Board (United
States) and as required by the Securities Act.
(u)
Title to Real and Personal Property . The
Company and its subsidiaries have good and marketable title in fee
simple to, or have valid rights to lease or otherwise use, all
items of real and personal property that are material to the
respective businesses of the Company and its subsidiaries, in each
case free and clear of all liens, encumbrances, claims and defects
and imperfections of title except as described in the General
Disclosure Package and the Final Prospectus those that (i) do
not materially interfere with the use made and proposed to be made
of such property by the Company and its subsidiaries or
(ii) could not reasonably be expected, individually or in the
aggregate, to have a Material Adverse Effect.
(v)
Title to Intellectual Property . Except as
described in the General Disclosure Package, the Company and its
subsidiaries own or possess adequate rights to use all material
patents, patent applications, trademarks, service marks, trade
names, trademark registrations or applications therefor, service
mark registrations or applications therefor, copyrights, licenses
and know-how (including trade secrets and other unpatented and/or
unpatentable proprietary or confidential information, systems or
procedures) (collectively, “ Intellectual Property
”), that is used in the conduct of their respective
businesses; and, to the knowledge of the Company, the conduct of
their respective businesses does not conflict in any material
respect with any such rights of others, and the Company has not
received any written, or to the knowledge of the Company, other
notice of infringement of or conflict with, and the Company has no
knowledge of any infringement of or conflict with, asserted rights
of others with respect to its Intellectual Property which could
reasonably be expected to result in a Material Adverse Effect.
Further, except as described in the General Disclosure Package, or
which would not reasonably be expected to result in a Material
Adverse Effect, the Company is not obligated to pay a royalty,
grant a license or provide other consideration to any third party
in connection with its Intellectual Property; and, to the knowledge
of the Company, no third party, including any academic or
governmental organization, possesses rights to the Company’s
Intellectual Property which, if exercised, could enable such third
party to develop products competitive with those of the Company or
its subsidiaries which could reasonably be expected to have a
Material Adverse Effect.
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(w)
Clinical Trials . The studies, tests and preclinical
and clinical trials conducted by or on behalf of the Company that
are described in the General Disclosure Package or the Final
Prospectus (collectively, the “ Products ”) and
that are described as ongoing, or the results of which are referred
to in the General Disclosure Package or the Final Prospectus, are
the only studies, tests and preclinical and clinical trials
currently being conducted by or on behalf of the Company with
respect to the Products. Nothing has come to the attention of the
Company that has caused the Company to believe that the studies,
tests and preclinical and clinical trials described in the General
Disclosure Package and the Final Prospectus were not and, to the
extent still pending, are not being conducted in all material
respects in accordance with experimental protocols, procedures and
controls pursuant to accepted professional scientific standards;
the descriptions of the results of such studies, tests and trials
contained in the General Disclosure Package and the Final
Prospectus are consistent in all material respects with such
results. Except as described in the General Disclosure Package and
the Final Prospectus, no results of any other studies or tests have
come to the attention of the Company that have caused the Company
to believe that such results are materially adverse to the results
described in the General Disclosure Package and the Final
Prospectus of the clinical trials. The Company has not received any
notices or correspondence from the Food and Drug Administration
(the “ FDA ”) or any other governmental agency
requiring the termination, suspension or modification of any
clinical trials currently conducted by, or on behalf of, the
Company or in which the Company has participated.
(x)
No Undisclosed Relationships . No
relationship, direct or indirect, exists between or among the
Company or any of its subsidiaries, on the one hand, and the
directors, officers, stockholders, customers or suppliers of the
Company or any of its subsidiaries, on the other, that is required
by the Securities Act to be described in the Registration Statement
and the General Disclosure Package and the Final Prospectus and
that is not so described in such documents.
(y)
Investment Company Act . The Company is not
and, after giving effect to the offering and sale of the Shares and
the application of the proceeds thereof as described in the
Registration Statement and the General Disclosure Package and the
Final Prospectus, will not be required to register as an
“investment company” or an entity
“controlled” by an “investment company”
within the meaning of the Investment Company Act of 1940, as
amended, and the rules and regulations of the Commission thereunder
(collectively, “ Investment Company Act
”).
(z)
Taxes . The Company and its subsidiaries have
paid all federal, state, local and foreign income taxes and filed
all income tax returns required to be paid or filed through the
date hereof; and except as otherwise disclosed in the Registration
Statement and the General Disclosure Package and the Final
Prospectus, there is no tax deficiency that has been, or could
reasonably be expected to be, asserted against th
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