3,500,000 Shares and 3,500,000 Warrants
OPEXA
THERAPEUTICS, INC.
Common
Stock and Common Stock Purchase Warrants
UNDERWRITING AGREEMENT
February
13, 2008
MDB
Capital Group LLC
As
Representative of the Several Underwriters named in
Schedule I hereto
401
Wilshire Boulevard
Santa
Monica, CA 90401
Ladies
and Gentlemen:
Opexa
Therapeutics, Inc., a Texas corporation (“ Company ”),
proposes to issue and sell to the several Underwriters (as
defined below) an aggregate of 3,500,000 shares of its common
stock, $0.50 par value per share (the “ Common Stock
”) and an aggregate of 3,500,000 common stock purchase
warrants, each warrant to purchase one share of common stock
for an exercise period of five years commencing the date of
issuance (the “ Public Series E
Warrants ”).
It
is understood that, subject to the conditions hereinafter
stated, an aggregate of 3,500,000 shares of the Common Stock
(the “ Firm Shares
”) and an aggregate of 3,500,000 Public Series E
Warrants (the “ Firm Warrants
”) (together the Firm Shares and the Firm Warrants are
referred to as the “ Firm Securities
”) will be sold to the several Underwriters named in
Schedule I hereto (the “ Underwriters
”) in connection with the offering (the “
Offering ”)
and sale of such Firm Securities. MDB Capital Group
LLC shall act as the representative (the “ Representative
”) of the several Underwriters. In addition,
as set forth below the Company proposes to issue and sell to
the Underwriters, upon the terms and conditions set forth in
Section 2, an aggregate of up to 525,000 additional shares of
the Common Stock (the “ Optional Shares
”) and an aggregate of up to 525,000 additional Series E
Warrants (the “ Optional Warrants
”) (together the Optional Shares and Optional Warrants
are referred to as the “ Optional
Securities ”). The Firm Securities and
the Optional Securities are hereinafter called the “
Securities
.”
This
is to confirm the agreement concerning the purchase of the
Securities from the Company by the Underwriters.
1.
Representations and Warranties. The Company
represents and warrants to, and agrees with, each Underwriter
that:
(a)
The
Company has prepared and filed with the Securities and Exchange
Commission (the “ Commission ”) a
registration statement on Form SB-2 (File No. 333-147167), which
contains a form of prospectus to be used in connection with the
public offering and sale of the Securities. Such
registration statement, as amended, including the financial
statements, exhibits and schedules thereto, in the form in which it
was declared effective by the Commission under the Securities Act
of 1933, as amended (the “ Securities Act ”)
and the rules and regulations promulgated thereunder (the “
Rules and
Regulations ”), including any required information
deemed to be a part thereof at the time of effectiveness pursuant
to Rule 430A under the Securities Act, is called the “
Registration
Statement. ” Any registration statement
filed by the Company pursuant to Rule 462(b) under the Securities
Act is called the “ Rule 462(b) Registration
Statement ”, and from and after the date and time of
filing of the Rule 462(b) Registration Statement the term “
Registration
Statement ” shall include the Rule 462(b) Registration
Statement. Any preliminary prospectus included in the
Registration Statement is hereinafter called a “ preliminary prospectus
.” The term “ Prospectus ”
shall mean the final prospectus relating to the Securities that is
first filed pursuant to Rule 424(b) after the date and time that
this Agreement is executed and delivered by the parties hereto (the
“ Execution
Time ”) or, if no filing pursuant to Rule 424(b) is
required, shall mean the form of final prospectus relating to the
Securities included in the Registration Statement at the time it
became effective. All references in this Agreement to
the Registration Statement, the Rule 462(b) Registration Statement,
a preliminary prospectus, the Prospectus, or any amendments or
supplements to any of the foregoing, shall include any copy thereof
filed with the Commission pursuant to its Electronic Data
Gathering, Analysis and Retrieval System (“ EDGAR
”).
(b)
The
Registration Statement and any Rule 462(b) Registration Statement
have been declared effective by the Commission under the Securities
Act. The Company has complied, to the Commission’s
satisfaction, with all requests of the Commission for additional or
supplemental information. No stop order suspending the
effectiveness of the Registration Statement or any Rule 462(b)
Registration Statement is in effect and no proceedings for such
purpose have been instituted or are pending or, to the best
knowledge of the Company, are contemplated or threatened by the
Commission.
The
final preliminary prospectus, as supplemented on January 23,
2008, included in the Disclosure Package (as defined below)
and the Prospectus when filed complied in all material
respects with the Securities Act and the rules thereunder and,
if filed by electronic transmission pursuant to EDGAR (except
as may be permitted by Regulation S-T under the Securities
Act), was identical to the copy thereof delivered to the
Underwriters for use in connection with the offer and sale of
the Securities. Each of the Registration Statement,
any Rule 462(b) Registration Statement and any post-effective
amendment thereto, at the time it became effective and at the
date hereof, the Closing Date and any Subsequent Closing Date,
complied and will comply in all material respects with the
Securities Act and did not 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 not misleading. The Prospectus
(including any Prospectus wrapper), as amended or
supplemented, as of its date and at the date hereof, the
Closing Date and any Option Closing Date, did not and will not
contain any untrue statement of a material fact or 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. The
representations and warranties set forth in the two
immediately preceding sentences do not apply to statements in
or omissions from the Registration Statement, any Rule 462(b)
Registration Statement, or any post-effective amendment
thereto, or the Prospectus, or any amendments or supplements
thereto, made in reliance upon and in conformity with
information relating to any Underwriter furnished to the
Company in writing by the Representative expressly for use
therein, it being understood and agreed that the only such
information furnished by the Representative consists of the
information described as such in Section 11
hereof. There are no contracts or other documents
required to be described in the Prospectus or to be filed as
exhibits to the Registration Statement which have not been
described or filed as required.
(c)
The
term “ Disclosure Package
” shall mean, collectively, (i) the preliminary prospectus
that is included in the Registration Statement immediately prior to
the Initial Sale Time (as defined below), if any, as amended or
supplemented, (ii) the issuer free writing prospectuses as defined
in Rule 433 of the Securities Act (each, an “ Issuer Free Writing
Prospectus ”) identified in Schedule III hereto, and
(iii) any other free writing prospectus that the parties hereto
shall hereafter expressly agree in writing to treat as part of the
Disclosure Package. As of 10:00A.M. (Eastern time) on
the date of this Agreement (the “ Initial Sale Time
”), the Disclosure Package did not contain 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 the Disclosure Package based upon
and in conformity with written information furnished to the Company
by the Representative specifically for use therein, it being
understood and agreed that the only such information furnished by
or on behalf of any Underwriter consists of the information
described as such in Section 11 hereof.
(d)
Each
Issuer Free Writing Prospectus, as of its issue date and at all
subsequent times through the completion of the Offering or until
any earlier date that the Company notified or notifies the
Representative 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 contained in the Registration
Statement. The foregoing sentence does not apply to
statements in or omissions from any Issuer Free Writing Prospectus
based upon and in conformity with written information furnished to
the Company by the Representative specifically for use therein, it
being understood and agreed that the only such information
furnished by any Underwriter consists of the information described
as such in Section 11 hereof.
(e)
The
Company has delivered to the Representative one complete manually
signed copy 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
preliminary prospectuses and the Prospectus, as amended or
supplemented, in such quantities and at such places as the
Representative have reasonably requested for each of the
Underwriters.
(f)
The
Company has not distributed and will not distribute, prior to the
later of the Option Closing Date (as defined in Section 3 below)
and the completion of the Underwriters' distribution of the
Securities, any offering material in connection with the offering
and sale of the Securities other than any preliminary prospectus,
the Prospectus, any Issuer Free Writing Prospectus reviewed and
consented to by the Representative or included in Schedule III
hereto or the Registration Statement.
(g)
Malone
& Bailey, PC, whose report appears in the Registration
Statement, and included in the Disclosure Package and the
Prospectus, are independent certified public accountants as
required by the Securities Act and the Rules and
Regulations. The financial statements and schedules
(including the related notes) included in the Registration
Statement, and included in the Disclosure Package and the
Prospectus, present fairly the financial condition, the results of
the operations and changes in financial condition of the entities
purported to be shown thereby at the dates or for the periods
indicated and have been prepared in accordance with generally
accepted accounting principles applied on a consistent basis
throughout the periods indicated. All adjustments
necessary for a fair presentation of results for such periods have
been made. The selected financial, operating and
statistical data set forth in any preliminary prospectus included
in the Disclosure Package and the Prospectus under the captions
“Prospectus Summary,” “Selected Consolidated
Financial Data” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations”
fairly present, when read in conjunction with the Company’s
financial statements and the related notes and schedules and on the
basis stated in the Registration Statement, the information set
forth therein.
(h)
Each
of the Company and its Subsidiaries (as defined in Section 13
hereof) has been duly incorporated and is validly existing as a
corporation in good standing under the laws of the jurisdiction of
its organization, with full power and authority (corporate and
other) to own or lease its properties and conduct its business as
described in the Disclosure Package and Prospectus, and is duly
qualified to do business and is in good standing as a foreign
corporation in each jurisdiction in which the character of the
business conducted by it or the location of the properties owned or
leased by it makes such qualification necessary; each of the
Company and its Subsidiaries is in possession of and operating in
compliance with all franchises, grants, authorizations, licenses,
permits, easements, consents, certificates and orders required for
the conduct of its business, all of which are valid and in full
force and effect (except with respect to each of the foregoing
representations, where any failure to do so would not result in a
material adverse change in the condition (financial or otherwise),
business, prospects, properties or results of operations of the
Company and its subsidiaries considered as a whole) (“
Material Adverse
Effect ”); and neither the Company nor any of its
Subsidiaries has received any notice of proceedings relating to the
revocation or modification of any such franchise, grant,
authorization, license, permit, easement, consent, certificate or
order which, individually or in the aggregate, if the subject of an
unfavorable decision, would result, individually or in the
aggregate, in having a Material Adverse Effect.
(i)
The
capitalization of the Company is as set forth in the Disclosure
Package and Prospectus, and the Common Stock and Warrants conform
to the descriptions thereof contained under the caption
“Description of Securities” in the Disclosure Package
and Prospectus; the outstanding shares of capital stock have been
duly authorized, validly issued, fully paid and nonassessable and
have been issued in compliance with federal and state securities
laws. There are no preemptive rights or other rights to
subscribe for or to purchase, or any restriction upon the voting or
transfer of, any shares of capital stock pursuant to the
Company’s certificate of incorporation, by-laws or other
governing documents or any agreement or other instrument to which
the Company or any of its Subsidiaries is a party or by which any
of them may be bound. None of the outstanding shares of
capital stock were issued in violation of any preemptive rights,
rights of first refusal or other similar rights to subscript 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 other than those accurately
described in the Disclosure Package and the
Prospectus. The description of the Company's stock
option, stock bonus and other stock plans or arrangements, and the
options or other rights granted thereunder, set forth in the
Disclosure Package and the Prospectus accurately and fairly
presents the information required to be shown with respect to such
plans, arrangements, options and rights. Neither the
filing of the Registration Statement nor the offering or sale of
the Securities as contemplated by this Agreement gives rise to any
rights, other than those which have been waived or satisfied, for
or relating to the registration of any shares of Common
Stock. All of the outstanding shares of capital stock of
each Subsidiary of the Company have been duly authorized and
validly issued, are fully paid and nonassessable and are owned
directly or indirectly by the Company, free and clear of any claim,
lien, encumbrance or security interest. Except as
disclosed in the Disclosure Package, 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 any Subsidiary.
(j)
Subsequent
to the respective dates as of which information is given in the
Disclosure Package and the Prospectus, and except as described or
contemplated in the Disclosure Package and the
Prospectus: neither the Company nor any of its
Subsidiaries has incurred any liabilities or obligations, direct or
contingent, nor entered into any transactions not in the ordinary
course of business, which in either case are material to the
Company or such Subsidiary, as the case may be; there has not been
any Material Adverse Effect; and there has been no dividend or
distribution of any kind declared, paid or made by the Company on
any class of its capital stock.
(k)
Neither
the Company nor any of its Subsidiaries is, or with the giving of
notice or lapse of time or both would be, in violation of or in
default under, nor will the execution or delivery hereof or
consummation of the transactions contemplated hereby result in a
violation of, or constitute a default under, the certificate of
incorporation, bylaws or other governing documents of the Company
or any of its Subsidiaries, or any agreement, contract, mortgage,
deed of trust, loan agreement, note, lease, indenture or other
instrument, to which the Company or any of its Subsidiaries is a
party or by which any of them is bound, or to which any of their
properties is subject, nor will the performance by the Company of
its obligations hereunder violate any law, rule, administrative
regulation or decree of any court, or any governmental agency or
body having jurisdiction over the Company, its Subsidiaries or any
of their properties, or result in the creation or imposition of any
lien, charge, claim or encumbrance upon any property or asset of
the Company or any of its Subsidiaries (except with respect to each
of the foregoing, where any such default or violation would not
result in a Material Adverse Effect). Except for permits
and similar authorizations required under the Securities Act and
the securities or “Blue Sky” laws of certain
jurisdictions and for such permits and authorizations which have
been obtained, no consent, approval, authorization or order of any
court, governmental agency or body or financial institution is
required in connection with the consummation of the transactions
contemplated by this Agreement (except where such failure would not
have a Material Adverse Effect).
(l)
This
Agreement has been duly authorized, executed and delivered by the
Company and constitutes a legal, valid and binding obligation of
the Company and is enforceable against the Company in accordance
with its terms.
(m)
The
Securities to be purchased by the Underwriters from the Company
have been duly authorized for issuance and sale pursuant to this
Agreement and, when issued and delivered by the Company pursuant to
this Agreement, will be validly issued, fully paid and
nonassessable. The issuance of the Securities pursuant
to this Agreement will not be subject to any preemptive rights,
rights of first refusal or other similar rights to subscribe for or
purchase securities of the Company. There are no
restrictions upon the voting or transfer of the Securities under
the Company’s certificate of incorporation or by laws or any
agreement or other instrument to which the Company is a party or
otherwise filed as an exhibit to the Registration
Statement.
(n)
The
warrants to purchase Common Stock and warrants to purchase Series E
Warrants to be issued to the Underwriters (the “ Underwriter Warrants
”) pursuant to Section 4(k) have been duly authorized for
issuance. The Company has reserved 700,000 shares of its
Common Stock for issuance upon exercise of the Underwriter Warrants
and when issued and paid for in accordance with the terms of the
Underwriter Warrants and the underlying Series E Warrants, such
Common Stock issuable thereunder will be validly issued, fully paid
and nonassessable. The issuance of the Common Stock
pursuant to the Underwriter Warrants and the underlying Series E
Warrants will not be subject to any preemptive rights, rights of
first refusal or other similar rights to subscript for or purchase
securities of the Company. There will be no restrictions
upon the voting or transfer of the Common Stock issuable pursuant
to the Underwriter Warrants and the underlying Series E Warrants
under the Company’s certificate of incorporation or bylaws or
any agreement or other instrument to which the Company is a party
or otherwise filed as an exhibit to the Registration
Statement.
(o)
The
Company and its Subsidiaries have good and marketable title in fee
simple to all items of real property and good and marketable title
to all personal property owned by them, in each case clear of all
liens, encumbrances and defects except such as are described or
referred to in the Disclosure Package and Prospectus or such as do
not materially affect the value of such property and do not
interfere with the use made or proposed to be made of such property
by the Company or such Subsidiaries; and any real property and
buildings held under lease by the Company and its Subsidiaries are
held by them under valid, existing and enforceable leases with such
exceptions as are not material and do not interfere with the use
made or proposed to be made of such property and buildings by the
Company or such Subsidiaries.
(p)
Except
as described in the Disclosure Package and the Prospectus, there is
no litigation or governmental proceeding to which the Company or
any of its Subsidiaries is a party or to which any property of the
Company or any of its Subsidiaries is subject or which is pending
or, to the knowledge of the Company, threatened against the Company
which individually or in the aggregate might result in any Material
Adverse Effect, which would materially and adversely affect the
consummation of this Agreement or the transactions contemplated
hereby or which is required to be disclosed in the Disclosure
Package and the Prospectus.
(q)
Neither
the Company nor any Subsidiary is in violation of any law,
ordinance, governmental rule or regulation or court decree to which
it may be subject which violation might have a Material Adverse
Effect.
(r)
The
Company has not taken and may not take, directly or indirectly, any
action designed to cause or result in, or which has constituted or
which might reasonably be expected to constitute, the stabilization
or manipulation of the price of the shares of Common Stock to
facilitate the sale or resale of the Securities.
(s)
The
Company and its Subsidiaries have filed all necessary federal,
state and foreign income and franchise tax returns, and all such
tax returns are complete and correct in all material respects, and
the Company and its Subsidiaries have not failed to pay any taxes
which were payable pursuant to said returns or any assessments with
respect thereto. The Company has no knowledge of any tax
deficiency which has been or is likely to be threatened or asserted
against the Company or its Subsidiaries.
(t)
The
Company maintains a system of internal accounting controls
sufficient to provide reasonable assurances that (i) transactions
are executed in accordance with management’s general or
specific authorization; (ii) transactions are recorded as necessary
to permit preparation of financial statements in conformity with
generally accepted accounting principles in the United States and
to maintain accountability for 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 existing assets at reasonable intervals and
appropriate action is taken with respect to any differences. Except
as disclosed in the Registration Statement, the Disclosure Package
and the Prospectus, since the date of the most recent evaluation of
such system of internal accounting controls, there has been no
material change in internal control over financial reporting,
including any corrective actions with regard to significant
deficiencies or material weaknesses.
(u)
The
Company and its Subsidiaries maintain insurance of the types and in
the amounts its Board of Director has determined reasonable for its
business, including, but not limited to, directors’ and
officers’ insurance, insurance covering real and personal
property owned or leased by the Company and its Subsidiaries
against theft, damage, destruction, acts of vandalism and all other
risks customarily insured against by companies of similar size and
stage of development, all of which insurance is in full force and
effect. The Company has not been refused any insurance
coverage sought or applied for, and the Company has no reason to
believe that it will not be able to renew its existing insurance
coverage as and when such coverage expires or to obtain similar
coverage from similar insurers as may be necessary to continue its
business at a cost that would not have a Material Adverse
Effect.
(v)
Neither
the Company nor any of its Subsidiaries nor, to the best of the
Company’s knowledge, any of its employees or agents has at
any time during the last five years (i) made any unlawful
contribution to any candidate for foreign office, or failed to
disclose fully any contribution in violation of law, or
(ii) made any payment to any foreign, federal or state
governmental officer or official or other person charged with
similar public or quasi-public duties, other than payments required
or permitted by the laws of the United States or any jurisdiction
thereof.
(w)
The
Company is not and, after giving effect to the offering and sale of
the Securities and the application of the proceeds thereof as
described under the caption “Use of Proceeds” in the
Disclosure Package or the Prospectus, will not be an
“investment company” as defined in the Investment
Company Act of 1940, as amended.
(x)
Except
as disclosed in the Disclosure Package or the Prospectus, there are
no contracts, agreements or understandings between the Company and
any person that would give rise to a valid claim against the
Company or any Underwriter for a brokerage commission,
finder’s fee or other like payment in connection with the
Offering.
(y)
Except
as disclosed in the Company’s reports under the Securities
Exchange Act of 1934, as amended (the “ Exchange Act ”),
there are no contracts, agreements or understandings between the
Company and any person granting such person the right to require
the Company to file a registration statement under the Securities
Act with respect to any securities of the Company owned or to be
owned by such person or to require the Company to include such
securities in the securities registered pursuant to a Registration
Statement or in any securities being registered pursuant to any
other registration statement filed by the Company under the
Securities Act.
(z)
The
Securities and the Common Stock and Series E Warrants reserved for
issuance under the Underwriter Warrants and Common Stock reserved
for issuance under the underlying Series E Warrants have been
approved for listing on The Nasdaq Capital Market subject only to
official notice of issuance. The Common Stock and the
Series E Warrants of the Company have been registered under Section
12(b) of the Exchange Act.
(aa)
The
Company is in material compliance with all applicable provisions of
the Sarbanes-Oxley Act of 2002 that are currently effective and the
rules and regulations promulgated in connection
therewith.
(bb)
No
consent, approval, authorization, or order of, or filing with, any
governmental agency or body or any court is required for the
consummation of the transactions contemplated by this Agreement in
connection with the issuance and sale of the Securities by the
Company, except such as have been obtained and made under the
Securities Act and such as may be required by the National
Association of Securities Dealers, Inc. (the “ NASD ”) or under
state securities laws or the laws of any foreign
jurisdiction.
(cc)
The
execution, delivery and performance of this Agreement, and the
issuance and sale of the Securities will not result in a breach or
violation of any of the terms and provisions of, or constitute a
default under, (i) any statute, any rule, regulation or order
of any governmental agency or body or any court, domestic or
foreign, having jurisdiction over the Company, except in the case
of this clause (i) for such breaches, violations or defaults which
would not, individually or in the aggregate, have a Material
Adverse Effect or (ii) any agreement or instrument to which
the Company is a party or by which the Company is bound, except in
the case of this clause (ii) for such breaches, violations or
defaults which would not, individually or in the aggregate, have a
Material Adverse Effect, or (iii) the charter or by-laws of
the Company, and the Company has full power and authority to
authorize, issue and sell the Securities as contemplated by this
Agreement.
(dd)
The
Company is not presently doing business with the government of Cuba
or with any person or affiliate located in Cuba.
(ee)
No
labor dispute with the employees of the Company or any subsidiary
exists or, to the knowledge of the Company, is imminent that might
have a Material Adverse Effect.
(ff)
To
the Company’s knowledge, the Company and its Subsidiaries own
or possess the right to use sufficient trademarks, trade names,
patent rights, copyrights, domain names, licenses, approvals, trade
secrets, inventions, technology, know-how and other similar rights
(collectively, “ Intellectual Property
Rights ”) as are (i) necessary or material to
conduct its business as now conducted and as described in the
Disclosure Package and the Prospectus and as are
(ii) necessary or material for the commercialization of the
products described in the Disclosure Package and the Prospectus as
being under development. Except as set forth in the
Disclosure Package and the Prospectus, (a) there is no pending
or, to the Company’s knowledge, threatened action, suit,
proceeding, or claim by others challenging the rights of the
Company or any of its Subsidiaries in or to any such Intellectual
Property Rights that, if decided adversely to the Company would,
individually or in the aggregate, have a Material Adverse Effect,
and the Company is unaware of any facts which would form a
reasonable basis for any such claim; (b) there is no pending,
or to the Company’s knowledge, threatened action, suit,
proceeding, or claim by others that the Company or any of its
Subsidiaries infringes, misappropriates, or otherwise violates any
Intellectual Property Rights, of others that, if decided adversely
to the Company would, individually or in the aggregate, have a
Material Adverse Effect, and the Company is unaware of any facts
which would form a reasonable basis for any such claim;
(c) there is no pending or, to the Company’s knowledge,
threatened action, suit, proceeding, or claim by others challenging
the validity, scope, or enforceability of any such Intellectual
Property Rights owned by the Company or its Subsidiaries and the
Company is unaware of any facts which would form a reasonable basis
for any such claim; (d) to the Company’s knowledge, the
operation of the business of the Company and its Subsidiaries as
now conducted, and as described in the Disclosure Package and the
Prospectus, and in connection with the development and
commercialization of the products described in the Disclosure
Package and the Prospectus does not infringe any claim of any
patent or published patent application; (e) there is no prior
art of which the Company is aware that may render any patent owned
or licensed by the Company or its Subsidiaries invalid or any
patent application owned or licensed by the Company unpatentable
which has not been disclosed to the applicable government patent
office; and (f) the Company’s granted or issued patents,
registered trademarks, and registered copyrights have been duly
maintained and are in full force and in effect, and none of the
patents, trademarks and copyrights have been adjudged invalid or
unenforceable in whole or in part. Neither the Company
nor any of its Subsidiaries is a party to or bound by any options,
licenses or agreements with respect to the Intellectual Property
Rights of any other person or entity that are required to be set
forth in the Disclosure Package and the Prospectus and are not
described therein in all material respects. None of the
technology or intellectual property used by the Company and its
Subsidiaries in its business has been obtained or is being used by
the Company or its Subsidiaries in violation of any contractual
obligation binding on the Company or its Subsidiaries, or, to the
Company’s knowledge, any of its officers, directors, or
employees or otherwise in violation of the rights of any
persons. No third party has been granted by the Company
or its Subsidiaries rights to the Intellectual Property Rights of
the Company or its Subsidiaries that, if exercised, could enable
such party to develop products competitive to those of the Company
as described in the Disclosure Package and the
Prospectus.
(gg)
The
Company has duly and properly filed or caused to be filed with the
U.S. Patent and Trademark Office (the “ PTO ”) and
applicable foreign and international patent authorities all patent
applications owned by the Company and its Subsidiaries (the “
Company Patent
Applications ”). To the knowledge of the
Company, the Company has complied with the PTO’s duty of
candor and disclosure for the Company Patent Applications and has
made no material misrepresentation in the Company Patent
Applications. To the Company’s knowledge, the
Company Patent Applications disclose patentable subject
matters. The Company has not been notified of any
inventorship challenges nor has any interference been declared or
provoked nor is any material fact known by the Company that would
preclude the issuance of patents with respect to the Company Patent
Applications or would render such patents, if issued, invalid or
unenforceable.
(hh)
Neither
the Company or any of its Subsidiaries has breached and is
currently in breach of any provision of any license, contract or
other agreement governing the use by the Company or its
Subsidiaries of Intellectual Property Rights owned by third parties
(collectively, the “ Licenses ”) and,
except as described in the Disclosure Package and the Prospectus,
no third party has alleged any such breach and the Company is
unaware of any facts that would form a reasonable basis for such a
claim. To the Company’s knowledge, no other party
to the Licenses has breached or is currently in breach of any
provision of the Licenses. Each of the Licenses is in
full force and effect and constitutes a valid and binding agreement
between the parties thereto, enforceable in accordance with its
terms, and there has not occurred any breach or default under any
such Licenses or any event that with the giving of notice or lapse
of time would constitute a breach or default
thereunder. Except as would not have a Material Adverse
Effect, neither the Company nor any of its Subsidiaries has been
and is currently involved in any disputes regarding the
Licenses. To the Company’s knowledge, all patents
licensed to the Company pursuant to the Licenses are valid,
enforceable and being duly maintained. To the
Company’s knowledge, all patent applications licensed to the
Company pursuant to the Licenses are being duly
prosecuted.
(ii)
The
studies that are referred to in the Disclosure Package and the
Prospectus and their protocols were, to the Company’s
knowledge, independently developed, analyzed and reported by the
persons or entities conducting the clinical studies. The
prospective studies that are referred to in the Disclosure Package
and the Prospectus were, to the Company’s knowledge,
conducted in all material respects in accordance with experimental
protocols, procedures and controls consistent with the standards
applied in other studies in the industry. The
retrospective studies that are referred to in the Disclosure
Package and the Prospectus were, to the Company’s knowledge,
statistically analyzed to ensure the results presented therein are
accurate in all material respects. The descriptions of
such clinical studies contained in the Disclosure Package and the
Prospectus are accurate in all material respects. The
Company has not received any notices or correspondence from the
U.S. Food and Drug Administration (the “ FDA ”) or any
foreign, state or local governmental or self-regulatory body
exercising comparable authority requiring the termination,
suspension or material modification of any such clinical studies,
which termination, suspension or material modification would
reasonably be expected to result in a Material Adverse
Effect.
(jj)
The
Company and its Subsidiaries are in compliance in all material
respects with all applicable rules and regulations of the FDA, or
any foreign, state or local governmental or self-regulatory body
exercising comparable authority, and all related applicable laws,
statutes, ordinances, rules or regulations (including, without
limitation, the Federal Food, Drug and Cosmetic Act, as amended,
the Good Manufacturing Practice regulations and similar foreign
laws and regulations), the enforcement of which, individually or in
the aggregate, would be expected to result in a Material Adverse
Effect.
(kk)
To
the Company’s knowledge, there are no rulemaking or similar
proceedings before the FDA, PTO, or any foreign, state or local
governmental or self-regulatory body exercising comparable
authority, which affect or involve the Company, its Subsidiaries,
or any of the products that the Company has developed, is
developing or proposes to develop or uses or proposes to use which,
if the subject of an action unfavorable to the Company, would
result in a Material Adverse Effect.
(ll)
The
Company and each Subsidiary possess such valid and current
certificates, authorizations, approvals or permits issued by the
appropriate state, federal, foreign regulatory agencies or bodies
necessary to conduct their respective businesses as currently
conducted and neither the Company nor any Subsidiary has received
any notice of proceedings relating to the revocation or
modification of, or non-compliance with, any such certificate,
authorization or permit which, singly or in the aggregate, if the
subject of an unfavorable decision, ruling or finding, could result
in a Material Adverse Effect.
(mm)
There
are no business relationships or related-party transactions
involving the Company or any Subsidiary or any other person
required to be described in the Disclosure Package and the
Prospectus that have not been described as required.
(nn)
Except
as would not, individually or in the aggregate, result in a
Material Adverse Effect (i)&n
