Exhibit 10.4
Execution
Copy
$30,000,000 Subordinated Convertible
Notes
Warrants to Purchase 1,466,994
Shares of Common Stock
Immunicon Corporation
PLACEMENT AGENCY
AGREEMENT
December 4, 2006
Deutsche Bank Securities
Inc.
60 Wall Street, 4 th Floor
New York, New York 10005
Ladies and Gentlemen:
Immunicon Corporation, a Delaware
corporation (the “Company”), proposes, subject to the
terms and conditions stated herein, to issue and sell (i) up
to $30,000,000 in aggregate principal amount of unsecured
subordinated convertible promissory notes (the “Notes”)
and (ii) Warrants (the “Warrants”) to purchase up
to an aggregate of 1,466,994 shares of the Company’s common
stock, $0.001 par value per share (the “Common Stock”),
to certain investors (each an “Investor” and,
collectively, the “Investors”). The Notes and the
Warrants are referred to herein collectively as the
“Securities.” The Company desires to engage Deutsche
Bank Securities Inc. (the “Placement Agent”) as its
exclusive placement agent subject to the terms and conditions set
forth in this Placement Agency Agreement (this
“Agreement”) in connection with such issuance and sale.
The Securities are more fully described in the Registration
Statement, the Disclosure Package and the Prospectus (each as
hereinafter defined).
In consideration of the mutual
agreements contained herein and of the interests of the parties in
the transactions contemplated hereby, the parties hereto agree as
follows:
1. A GREEMENT TO A CT AS P LACEMENT A GENT ; D ELIVERY AND P AYMENT .
On the basis of the representations,
warranties and agreements of the Company herein contained, and
subject to the terms and conditions set forth in this
Agreement:
(a) The Company hereby engages the
Placement Agent to act as its exclusive placement agent in
connection with the issuance and sale by the Company of the
Securities to the Investors and the Placement Agent hereby agrees,
as agent of the Company, to use its best efforts to solicit offers
to purchase the Securities from the Company upon the terms and
conditions set forth in the Prospectus. Upon the occurrence of the
Closing (as hereinafter defined), the Company shall pay to the
Placement Agent, by wire transfer of immediately available funds
payable to the order of the Placement Agent, to an account
designated by the Placement Agent, an aggregate of seven percent
(7.0%) of the gross proceeds received by the Company from its
sale of the Securities (the “Placement Fee”). Prior to
the earlier of (i) the date on which this Agreement is
terminated and (ii) the Closing Date (as
hereinafter
defined), the Company shall not,
without the prior written consent of the Placement Agent, solicit
or accept offers to purchase the Securities (other than pursuant to
the issuance of Common Stock upon exercise of stock options and
warrants disclosed as outstanding in the Registration Statement and
the Prospectus and the grant or issuance of stock options or shares
under existing equity compensation plans or stock purchase plans
described in the Registration Statement or the Prospectus)
otherwise than through the Placement Agent in accordance
herewith.
(b) The Company expressly
acknowledges and agrees that the Placement Agent’s
obligations hereunder are on a best efforts basis and this
Agreement shall not give rise to a commitment by the Placement
Agent or any of its affiliates to underwrite or purchase any of the
Securities or otherwise provide any financing, and the Placement
Agent shall have no authority to (and agrees not to purport to)
bind the Company in respect of the sale of any of the Securities.
The sale of the Securities shall be made pursuant to a securities
purchase agreement to be entered into between the Company and the
Investors (the “Purchase Agreement” and together with
the Notes and the Warrants, the “Other Transaction
Documents”). The Company shall have the sole right to accept
offers to purchase the Securities and may reject any such offer in
whole or in part in its sole discretion. Notwithstanding the
foregoing, it is understood and agreed that the Placement Agent or
any of its affiliates may, solely at its discretion and without any
obligation to do so, purchase the Securities as principal;
provided, however , that any such purchase by the Placement
Agent (or its affiliates) shall be fully disclosed to the Company
and approved by the Company in accordance with the previous
sentence.
(c) Payment of the purchase price
for, and delivery of, the Securities shall be made at a closing
(the “Closing”) in accordance with, and subject to, the
terms of the Purchase Agreement (such date of payment and delivery
being herein called the “Closing Date”). All such
actions taken at the Closing shall be deemed to have occurred
simultaneously. None of the Securities which the Company has agreed
to sell pursuant to this Agreement and the Other Transaction
Documents shall be deemed to have been purchased and paid for, or
sold by the Company, until such Securities shall have been
delivered to the Investor thereof against payment therefore by such
Investor. If the Company shall default in its obligations to
deliver the Securities to an Investor whose offer it has accepted,
the Company shall indemnify and hold the Placement Agent harmless
against any loss, claim or damage arising from or as a result of
such default by the Company.
2. R EPRESENTATIONS AND W ARRANTIES OF THE C OMPANY .
The Company represents and warrants
to the Placement Agent as follows:
(a) A “shelf”
registration statement on Form S-3 (File No. 333-124714) with
respect to the Securities has been prepared by the Company in
conformity in all material respects with the requirements of the
Securities Act of 1933, as amended (the “Act”), and the
rules and regulations (the “Rules and Regulations”) of
the Securities and Exchange Commission (the
“Commission”) thereunder and has been filed with the
Commission. The Company and the transactions contemplated by this
Agreement meet the requirements and comply with the conditions for
the use of Form S-3. The Registration Statement (as defined below)
meets the requirements of Rule 415(a)(1)(x) under the Act and
complies in all material respects with said rule. Copies of such
registration statement, including any amendments thereto, the base
prospectus (meeting in all material respects the requirements of
the Rules and Regulations) contained therein and the exhibits,
financial statements and schedules, as finally amended and revised,
have heretofore been delivered by the Company to you. Such
registration statement, together with any registration statement
filed by the Company pursuant to Rule 462(b) under the Act, is
herein referred to as the “Registration Statement,”
which shall be deemed to include all information omitted therefrom
in reliance upon Rules
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430A, 430B or 430C under the Act and
contained in the Prospectus referred to below, has become effective
under the Act and no post-effective amendment to the Registration
Statement (except to the extent that the Company’s filing of
its Form 10-K on March 15, 2006, as amended by the
Company’s Form 10-K/A filed on April 13, 2006
(collectively, the “Annual Report”) constitutes such a
post-effective amendment) has been filed as of the date of this
Agreement. The term “Prospectus” as used in this
Agreement means the form of base prospectus together with the final
prospectus supplement relating to the Securities first filed with
the Commission pursuant to and within the time limits described in
Rule 424(b) under the Act. Any preliminary prospectus relating to
the Securities prior to the date hereof is referred to as a
“Preliminary Prospectus.” Any reference herein to the
Registration Statement, any Preliminary Prospectus or the
Prospectus or to any amendment or supplement to any of the
foregoing documents shall be deemed to refer to and include any
documents incorporated by reference therein, and, in the case of
any reference herein to the Prospectus, also shall be deemed to
include any documents incorporated by reference therein, and any
supplements or amendments thereto, filed with the Commission after
the date of filing of the Prospectus Supplement under Rule 424(b)
under the Act, and prior to the termination of the offering of the
Securities by the Placement Agent.
(b) As of the Applicable Time (as
defined below) and as of the Closing Date (as defined below),
neither (i) the General Use Free Writing Prospectus(es) (as
defined below) issued at or prior to the Applicable Time and the
Statutory Prospectus (as defined below), all considered together
(collectively, the “General Disclosure Package”), nor
(ii) any individual Limited Use Free Writing Prospectus (as
defined below), when considered together with the General
Disclosure Package, included or will include any untrue statement
of a material fact or omitted or will 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;
provided, however, that the Company makes no representations or
warranties as to information contained in or omitted from any
Issuer Free Writing Prospectus, in reliance upon, and in conformity
with, written information furnished to the Company by or on behalf
of the Placement Agent, specifically for use therein, it being
understood and agreed that the only such information is that
described in Section 13 herein. As used in this subsection and
elsewhere in this Agreement:
“Applicable Time” means
5:30 pm (New York time) on the date of this Agreement or such other
time as agreed to by the Company and the Placement
Agent.
“Statutory Prospectus”
as of any time means the Preliminary Prospectus relating to the
Securities that is included in the Registration Statement
immediately prior to that time.
“Issuer Free Writing
Prospectus” means any “issuer free writing
prospectus,” as defined in Rule 433 under the Act, relating
to the Securities 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)
under the Act.
“General Use Free Writing
Prospectus” means any Issuer Free Writing Prospectus that is
identified on Schedule I to this Agreement.
“Limited Use Free Writing
Prospectus” means any Issuer Free Writing Prospectus that is
not a General Use Free Writing Prospectus.
(c) The Company has been duly
organized and is validly existing as a corporation in good standing
under the laws of the State of Delaware, with corporate power and
authority to own or lease its properties and conduct its business
as described in the Registration Statement, the General
Disclosure
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Package and the Prospectus. The
Company has no significant subsidiaries (as such term is defined in
Rule 1-02 of Regulation S-X promulgated by the Commission) other
than as listed in Exhibit 21.1 to the Annual Report (collectively,
the “Subsidiaries”). Each of the Subsidiaries has been
duly organized and is validly existing as an entity in good
standing under the laws of the jurisdiction of its organization,
with corporate power and authority to own or lease its properties
and conduct its business as described in the Registration
Statement, the General Disclosure Package and the Prospectus. The
Subsidiaries are the only subsidiaries, direct or indirect, of the
Company. The Company and each of the Subsidiaries are duly
qualified to transact business in all jurisdictions in which the
conduct of their business requires such qualification, except where
the failure to be so qualified would not reasonably be expected to
(i) result in any material adverse change, or any development
that would reasonably be expected to result in a material adverse
change, in or affecting the business, results of operations, or
financial condition of the Company and of the Subsidiaries taken as
a whole, whether or not occurring in the ordinary course of
business, or (ii) prevent, burden or impair the consummation
of the transactions contemplated by this Agreement (collectively a
“Material Adverse Effect”). The outstanding shares of
capital stock of each of the Subsidiaries have been duly authorized
and validly issued, are fully paid and non-assessable and are owned
by the Company or another Subsidiary free and clear of all liens,
encumbrances and equities and claims, except as described in the
Registration Statement and the Annual Report; and no options,
warrants or other rights to purchase, agreements or other
obligations to issue or other rights to convert any obligations
into shares of capital stock or ownership interests in the
Subsidiaries are outstanding.
(d) The outstanding shares of Common
Stock of the Company have been duly authorized and validly issued
and are fully paid and non-assessable; the Securities to be issued
and sold by the Company have been duly authorized and when issued
and paid for as contemplated herein will be validly issued; the
shares of Common Stock issuable upon conversion of the Notes (the
“Conversion Shares”) and exercise of the Warrants (the
“Warrant Shares”) have been duly authorized and validly
reserved for issuance upon conversion of the Notes and exercise of
the Warrants and, upon conversion of the Notes and exercise of the
Warrants in accordance with their terms, will be validly issued,
fully paid and non-assessable; and no preemptive rights of
stockholders exist with respect to any of the Securities, the
shares of Common Stock issuable upon conversion of the Notes and
exercise of the Warrants, or the issue and sale thereof. As of the
Closing, a number of shares of Common Stock shall have been duly
authorized and reserved for issuance which equals or exceeds 130%
of the aggregate of the maximum number of shares of Common Stock
issuable as of the Closing Date (i) upon conversion of the
Notes and (ii) upon exercise of the Warrants. Neither the
filing of the Registration Statement nor the offering or sale of
the Securities as contemplated by this Agreement and the Other
Transaction Documents, nor the issuance of shares of Common Stock
upon conversion of the Notes and exercise of the Warrants gives or
will give 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 or other securities of the
Company.
(e) As of the date hereof and as of
the Closing Date, the Company has or will have, as the case may be,
an authorized, issued and outstanding capitalization as is set
forth in the Registration Statement and the Prospectus (subject, in
each case, to the issuance of shares of Common Stock upon exercise
of stock options and warrants disclosed as outstanding in the
Registration Statement and the Prospectus, the grant or issuance of
options or shares under existing equity compensation plans or stock
purchase plans described in the Registration Statement or the
Prospectus, and the issuance of shares of Common Stock upon
conversion of the Notes and exercise of the Warrants), and such
authorized capital stock conforms to the description thereof set
forth in the Registration Statement and the Prospectus. All of the
Securities conform to the description thereof contained in the
Registration Statement and the Prospectus. The form of certificates
for the Warrant Shares and the Conversion Shares will conform to
the corporate law of the jurisdiction of the Company’s
incorporation.
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(f) The Commission has not issued an
order preventing or suspending the use of any Preliminary
Prospectus, any Issuer Free Writing Prospectus or the Prospectus
relating to the proposed offering of the Securities, and no
proceeding for that purpose or pursuant to Section 8A of the
Act has been instituted or, to the Company’s knowledge,
threatened by the Commission. The Registration Statement contains,
and the Prospectus and any amendments or supplements thereto will
conform to the requirements of the Act and the Rules and
Regulations. The documents incorporated, or to be incorporated, by
reference in the Prospectus, at the time filed with the Commission
conformed in all material respects, or will conform in all
respects, to the requirements of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), as applicable,
and the Rules and Regulations. The Registration Statement and any
amendment thereto do not contain, and on the Closing Date will not
contain, any untrue statement of a material fact and do not omit,
and on the Closing Date will not omit, to state a material fact
required to be stated therein or necessary to make the statements
therein not misleading. The Prospectus and any amendments and
supplements thereto do not contain, and on the Closing Date will
not contain, any untrue statement of a material fact; and do not
omit, and on the Closing Date will not 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; provided, however, that the Company makes no
representations or warranties as to information contained in or
omitted from the Registration Statement or the Prospectus, or any
such amendment or supplement, in reliance upon, and in conformity
with, written information furnished to the Company by or on behalf
of the Placement Agent, specifically for use therein, it being
understood and agreed that the only such information is that
described in Section 13 herein.
(g) 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
Securities or until any earlier date that the Company notified or
notifies the Placement Agent 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 or the Prospectus, including any document
incorporated by reference therein that has not been superseded or
modified. 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 included or 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 light of the
circumstances, not misleading, the Company has notified or will
notify promptly the Placement Agent so that any use of such Issuer
Free Writing Prospectus may cease until it is amended or
supplemented. The foregoing two sentences do not apply to
statements or omissions from any Issuer Free Writing Prospectus
based upon and in conformity with written information furnished to
the Company by the Placement Agent specifically for use
therein.
(h) The Company has not, directly or
indirectly, distributed and will not distribute any offering
material in connection with the offering and sale of the Securities
other than any Preliminary Prospectus, the Prospectus, any
Permitted Free Writing Prospectus (as defined below) and other
materials, if any, permitted under the Act and consistent with
Section 4(b)(ii) below. The Company will file with the
Commission all Issuer Free Writing Prospectuses in the time
required under Rule 433(d) under the Act. The Company has satisfied
or will satisfy the conditions in Rule 433 under the Act to avoid a
requirement to file with the Commission any electronic road
show.
(i) (i) At the time of filing the
Registration Statement and (ii) as of the date hereof (with
such date being used as the determination date for purposes of this
clause (ii)), the Company was not and is not an “ineligible
issuer” (as defined in Rule 405 under the Act, without taking
into account any determination by the Commission pursuant to Rule
405 under the Act that it is not necessary that the
5
Company be considered an ineligible
issuer), including, without limitation, for purposes of Rules 164
and 433 under the Act with respect to the offering of the
Securities as contemplated by the Registration
Statement.
(j) The condensed consolidated
financial statements of the Company and the Subsidiaries, together
with related notes and schedules as set forth or incorporated by
reference in the Registration Statement, the General Disclosure
Package and the Prospectus, present fairly in all material respects
the financial position and the results of operations and cash flows
of the Company and the consolidated Subsidiaries, at the indicated
dates and for the indicated periods. Such condensed consolidated
financial statements and related schedules have been prepared in
accordance with generally accepted principles of accounting
(“GAAP”), consistently applied throughout the periods
involved, except as disclosed therein, and all adjustments
necessary for a fair presentation of results for such periods have
been made. The summary and selected consolidated financial and
statistical data included or incorporated by reference in the
Registration Statement, the General Disclosure Package and the
Prospectus presents fairly in all material respects the information
shown therein, at the indicated dates and for the indicated
periods, and such data has been compiled on a basis consistent with
the financial statements presented therein and the books and
records of the Company. All disclosures, if any, contained in the
Registration Statement, the General Disclosure Package and the
Prospectus regarding “non-GAAP financial measures” (as
such term is defined by the Rules and Regulations) comply in all
material respects with Regulation G of the Exchange Act and
Item 10 of Regulation S-K under the Act, to the extent
applicable. The Company and the Subsidiaries do not have any
material liabilities or obligations, direct or contingent
(including any off-balance sheet obligations or any “variable
interest entities” within the meaning of Financial Accounting
Standards Board Interpretation No. 46), not disclosed in the
Registration Statement, the General Disclosure Package and the
Prospectus. There are no financial statements (historical or pro
forma) that are required to be included in the Registration
Statement, the General Disclosure Package or the Prospectus that
are not included as required.
(k) Deloitte & Touche LLP,
who have certified certain of the financial statements filed with
the Commission as part of, or incorporated by reference in, the
Registration Statement, the General Disclosure Package and the
Prospectus, has represented to the Company that it is an
independent registered public accounting firm with respect to the
Company and the Subsidiaries within the meaning of the Act and the
applicable Rules and Regulations and the Public Company Accounting
Oversight Board (United States) (the
“PCAOB”).
(l) Except as disclosed in the
Registration Statement, the General Disclosure Package and the
Prospectus, neither the Company nor any of the Subsidiaries is
aware of (i) any material weakness in its internal control
over financial reporting or (ii) change in internal control
over financial reporting that has materially affected, or is
reasonably likely to materially affect, the Company’s
internal control over financial reporting.
(m) Solely to the extent that the
Sarbanes-Oxley Act of 2002, as amended, and the rules and
regulations promulgated by the Commission and the Nasdaq Global
Market thereunder (collectively, the “Sarbanes-Oxley
Act”) has been applicable to the Company, there is and has
been no failure on the part of the Company to comply in all
material respects with any provision of the Sarbanes-Oxley Act. The
Company has taken all necessary actions to ensure that it is in
compliance in all material respects with all provisions of the
Sarbanes-Oxley Act that are in effect with respect to which the
Company is required to comply and is actively taking steps to
ensure that it will be in compliance with the other provisions of
the Sarbanes-Oxley Act which will become applicable to the
Company.
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(n) There is no action, suit, claim
or proceeding pending or, to the knowledge of the Company,
threatened against the Company or any of the Subsidiaries before
any court or administrative agency or otherwise which if determined
adversely to the Company or any of the Subsidiaries would have,
individually or in the aggregate, a Material Adverse Effect, except
as set forth in the Registration Statement, the General Disclosure
Package and the Prospectus.
(o) The Company and the Subsidiaries
have good and marketable title to all of the material properties
and assets reflected in the condensed consolidated financial
statements hereinabove described or described in the Registration
Statement, the General Disclosure Package and the Prospectus,
subject to no lien, mortgage, pledge, charge or encumbrance of any
kind except those reflected in such financial statements or
described in the Registration Statement, the General Disclosure
Package and the Prospectus or which are not material in amount or
would not materially interfere with the use to be made of such
properties or assets. The Company and the Subsidiaries occupy their
leased properties under valid and binding leases conforming in all
material respects to the description thereof set forth in the
Registration Statement, the General Disclosure Package and the
Prospectus.
(p) The Company and the Subsidiaries
have filed all Federal, State, local and foreign tax returns which
have been required to be filed and have paid all taxes indicated by
such returns and all assessments received by them or any of them to
the extent that such taxes have become due and are not being
contested in good faith and for which an adequate reserve for
accrual has been established in accordance with GAAP. All tax
liabilities have been adequately provided for in the condensed
consolidated financial statements of the Company in accordance with
GAAP, and the Company does not know of any actual or proposed
additional material tax assessments.
(q) Since the respective dates as of
which information is given in the Registration Statement, the
General Disclosure Package and the Prospectus, as each may be
amended or supplemented, there has not been any Material Adverse
Effect, and there has not been any material transaction entered
into by the Company or the Subsidiaries, other than transactions in
the ordinary course of business and transactions described in the
Registration Statement, the General Disclosure Package and the
Prospectus, as each may be amended or supplemented. The Company and
the Subsidiaries have no material contingent obligations which are
not disclosed in the Company’s condensed consolidated
financial statements which are included in the Registration
Statement, the General Disclosure Package and the
Prospectus.
(r) Neither the Company nor any of
the Subsidiaries is or with the giving of notice or lapse of time
or both, will be, (i) in violation of its certificate of
incorporation, by-laws, or other organizational documents or
(ii) in violation of or in default under any agreement, lease,
contract, indenture or other instrument or obligation to which it
is a party or by which it, or any of its properties, is bound and,
solely with respect to this clause (ii), which violation or default
would have a Material Adverse Effect. The execution and delivery of
this Agreement and the Other Transaction Documents and the
consummation of the transactions herein and therein contemplated
and the fulfillment of the terms hereof and thereof will not
conflict with or result in a breach of any of the terms or
provisions of, or constitute a default under, any indenture,
mortgage, deed of trust or other agreement or instrument to which
the Company or any Subsidiary is a party or by which the Company or
any Subsidiary or any of their respective properties is bound, or
of the certificate of incorporation or by-laws of the Company or
any law, order, rule or regulation judgment, order, writ or decree
applicable to the Company or any Subsidiary of any court or of any
government, regulatory body or administrative agency or other
governmental body having jurisdiction, except to the extent that
such conflict, breach or default would not have a Material Adverse
Effect.
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(s) There is no document, contract
or other agreement required to be described in the Registration
Statement or Prospectus or to be filed as an exhibit to the
Registration Statement which is not described or filed as required
by the Act or the Rules and Regulations. Each description of a
contract, document or other agreement in the Registration Statement
and the Prospectus accurately reflects in all material respects the
terms of the underlying contract, document or other agreement. Each
contract, document or other agreement described in the Registration
Statement and Prospectus or listed in the exhibits to the
Registration Statement or incorporated by reference is in full
force and effect and is valid and enforceable by and against the
Company in accordance with its terms (except as rights to indemnity
and contribution thereunder may be limited by federal or state
securities laws and matter of public policy and except as the
enforceability thereof may be limited by bankruptcy, insolvency,
reorganization, moratorium or other similar laws affecting the
enforcement of creditors’ rights generally and by general
equitable principle). Neither the Company nor any of its
Subsidiaries nor, to the Company’s knowledge, any other party
is in default in the observance or performance of any term or
obligation to be performed by it under any such agreement or any
other agreement or instrument to which the Company or its
Subsidiaries is a party or by which the Company or its Subsidiaries
or their respective properties or businesses may be bound, and no
event has occurred which with notice or lapse of time or both would
constitute such a default, in any such case in which the default or
event, individually or in the aggregate, would have a Material
Adverse Effect.
(t) The Company has the requisite
corporate power and authority to enter into and perform its
obligations under this Agreement and the Other Transaction
Documents and to issue the Securities in accordance with the terms
hereof and thereof. The execution and delivery of this Agreement
and the Other Transaction Documents by the Company and the
consummation by the Company of the transactions contemplated hereby
and thereby, including, without limitation, the issuance of the
Notes and the Warrants, the reservation for issuance and the
issuance of the shares of Common Stock issuable upon conversion of
the Notes, and the reservation for issuance and issuance of the
shares of Common Stock issuable upon exercise of the Warrants, have
been duly authorized by the Company’s Board of Directors, no
further filing, consent, or authorization is required by the
Company’s board of directors or its stockholders. This
Agreement and the Other Transaction Documents of even date herewith
have been duly executed and delivered by the Company, and
constitute the legal, valid and binding obligations of the Company,
enforceable against the Company in accordance with their respective
terms, except as such enforceability may be limited by general
principles of equity or applicable bankruptcy, insolvency,
reorganization, moratorium, liquidation or similar laws relating
to, or affecting generally, the enforcement of applicable
creditors’ rights and remedies.
(u) Each approval, consent, order,
authorization, designation, declaration or filing by or with any
regulatory, administrative or other governmental body necessary in
connection with the execution and delivery by the Company of this
Agreement and the Other Transaction Documents and the consummation
of the transactions herein and therein contemplated (except such
additional steps as may be required by the Commission, the National
Association of Securities Dealers, Inc. (the “NASD”) or
such additional steps as may be necessary to qualify the Securities
for a public offering by the Placement Agent under state securities
or Blue Sky laws) has been obtained or made and is in full force
and effect. The Company and its Subsidiaries are unaware of any
facts or circumstances that might prevent the Company from
obtaining or effecting any of the approvals, consents, orders,
authorizations, designations, declarations or filings pursuant to
the preceding sentence.
(v) Except as described in the
Registration Statement or in any document incorporated by reference
therein, the Company and each of the Subsidiaries hold all material
licenses, certificates and permits from governmental authorities
which are necessary to the conduct of their businesses in the
manner
8
in which they are being conducted;
the Company and the Subsidiaries each own or possess the right to
use all patents, patent rights, trademarks, trade names, service
marks, service names, copyrights, license rights, know-how
(including trade secrets and other unpatented and unpatentable
proprietary or confidential information, systems or procedures) and
other intellectual property rights (“Intellectual
Property”) necessary to carry on their business in all
material respects in the manner in which it is being conducted; to
the Company’s knowledge, neither the Company nor any of the
Subsidiaries has infringed, and none of the Company or the
Subsidiaries have received notice of conflict with, any
Intellectual Property of any other person or entity. The Company
has taken all steps reasonably necessary to secure ownership
interests in Intellectual Property created for it by any
contractors. There are no outstanding options, licenses or
agreements of any kind relating to the Intellectual Property of the
Company that are required to be described in the Registration
Statement, the General Disclosure Package and the Prospectus and
are not described therein in all material respects. The Company is
not a party to or bound by any options, licenses or agreements with
respect to the Intellectual Property of any other person or entity
that are required to be set forth in the Prospectus and are not
described therein in all material respects. None of the technology
employed by the Company and material to the Company’s
business has been obtained or is being used by the Company in
violation of any contractual obligation binding on the Company or,
to the Company’s knowledge, any of its officers, directors or
employees or, to the Company’s knowledge, otherwise in
violation of the rights of any persons; the Company has not
received any written or oral communications alleging that the
Company has violated, infringed or conflicted with, or, by
conducting its business as set forth in the Registration Statement,
the General Disclosure Package and the Prospectus, would violate,
infringe or conflict with, any of the Intellectual Property of any
other person or entity. The Company knows of no infringement by
others of Intellectual Property owned by or licensed to the
Company.
(w) Since the respective dates as of
which information is set forth in the Registration Statement, the
General Disclosure Package and the Prospectus, (i) all of the
descriptions of the Company’s legal and governmental
proceedings and procedures before the United States Food and Drug
Administration (the “FDA”) or any other national,
departmental, state or local governmental body exercising
comparable authority are true and correct in all material respects,
(ii) the studies, tests and preclinical and clinical trials
conducted by or on behalf of the Company and its Subsidiaries that
are described in the Registration Statement, the General Disclosure
Package and the Prospectus were and, if still pending, are
(a) with respect to the foregoing conducted by employees of
the Company or any of its Subsidiaries (“Company
Studies”), being conducted in accordance with experimental
protocols, procedures and controls pursuant to, where applicable,
accepted professional scientific standards, in each case in all
necessary respects and in all material respects; and (b) with
respect to the foregoing conducted on behalf of the Company or
independently by others using the Company’s or any of its
Subsidiaries’ technologies, products or product candidates
(“Independent Studies”), to the Company’s
knowledge, after due inquiry, being conducted in accordance with
experimental protocols, procedures and controls pursuant to, where
applicable, accepted professional scientific standards, in each
case in all necessary respects and in all material respects;
(iii) the descriptions of the results of the Company Studies,
and, to the Company’s knowledge, after due inquiry, the
Independent Studies, contained in the Registration Statement, the
General Disclosure Package and the Prospectus are true and correct
in all material respects; and (iv) except as disclosed in the
Registration Statement, the General Disclosure Package and the
Prospectus, neither the Company nor its Subsidiaries have received
any notices or correspondence from the FDA, or any national, state
or local governmental body exercising comparable authority
requiring the termination, suspension or material modification of
any of the Company Studies or Independent Studies.
(x) Neither the Company, nor to the
Company’s knowledge, any of its affiliates, has taken or may
take, directly or indirectly, any action designed to cause or
result in, or which has constituted
9
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.
(y) Neither the Company nor any
Subsidiary is or, after giving effect to the offering and sale of
the Securities contemplated hereunder and the application of the
net proceeds from such sale as described in the Prospectus, will be
an “investment company” within the meaning of such term
under the Investment Company Act of 1940 as amended (the
“1940 Act”), and the rules and regulations of the
Commission thereunder.
(z) The Company and each of the
Subsidiaries 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 GAAP 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.
(aa) The Company has established and
maintains “disclosure controls and procedures” (as
defined in Rules 13a-14(
