869,565 Shares
Warrants to Purchase 1,043,478
Shares
DELCATH SYSTEMS,
INC.
Common Stock
PLACEMENT AGENCY
AGREEMENT
June 9, 2009
Minneapolis,
Minnesota 55402
Ladies and
Gentlemen:
Delcath Systems, Inc., a Delaware corporation
(the “ Company ”), proposes, subject to the
terms and conditions stated in 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 investors identified therein (each, an “ Investor
” and collectively, the “ Investors ”), to
issue and sell up to an aggregate of 869,565 shares (the “
Shares ”) of the Company’s common stock, par
value $0.01 per share (the “ Common Stock ”).
Each Investor shall also receive a warrant, in the form of
Exhibit B attached hereto, to purchase up to a number of
shares of the Company’s Common Stock (the “ Warrant
Shares ”) equal to one hundred twenty percent (120%) of
the number of Shares purchased by such Investor, at an exercise
price equal to $3.99 per share, exercisable on or after the
issuance thereof and on or prior to the fifth anniversary of the
issuance thereof (the “ Warrants ” and together
with the Shares, the “ Securities ”). The
Company hereby confirms its agreement with Piper Jaffray & Co.
(the “ Placement Agent ”) as set forth below.
The Securities are more fully described in the Prospectus (as
defined below).
1.
Agreement to Act as Placement Agent; Delivery and
Payment . 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, as agent of the
Company, to, on commercially reasonable efforts basis, solicit
offers to purchase Securities from the Company on the terms and
subject to the conditions set forth in the Prospectus (as defined
below). The Placement Agent shall use commercially reasonable
efforts to assist the Company in obtaining performance by each
Investor whose offer to purchase the Securities was solicited by
such Placement Agent and accepted by the Company, but the Placement
Agent shall not, except as otherwise provided in this Agreement,
have any liability to the Company in the event any such purchase is
not consummated for any reason. Under no circumstances will the
Placement Agent or any of its affiliates be obligated to underwrite
or purchase any of the Securities for its own account or otherwise
provide any financing. The Placement Agent shall act
solely as the Company’s agent and not as principal. The
Placement Agent shall have no authority to bind the Company with
respect to any prospective offer to purchase Securities and the
Company shall
have the sole
right to accept offers to purchase Securities and may reject any
such offer, in whole or in part. Notwithstanding the foregoing, it
is understood and agreed that the Placement Agent (or its
affiliates) may, solely in its discretion and without any
obligation to do so, purchase Securities as principal.
(b) As
compensation for services rendered by the Placement Agent
hereunder, on the Closing Date (as defined below), the Company
shall pay or cause to be paid by the Investor to the Placement
Agent by wire transfer of immediately available funds to an account
or accounts designated by the Placement Agent, an aggregate amount
equal to seven percent (7.0%) of the gross proceeds received by the
Company from its sale of the Securities on such Closing Date (the
“ Agency Fee ”). Such gross purchase price does
not include any consideration that may be paid to the Company in
the future upon exercise of the Warrants. The Placement Agent
agrees that the foregoing compensation, together with any expense
reimbursement payable hereunder, constitutes all of the cash
compensation that such Placement Agent shall be entitled to receive
in connection with the Offering contemplated hereby.
(c) The
Securities are being sold to the Investors at a price of $3.45 per
unit (the “ Purchase Price ”) as set forth on
the cover page of the Prospectus (as defined below). The purchases
of Securities by the Investors shall be evidenced by the execution
of the Subscription Agreements by each of the parties thereto in
the form attached hereto as Exhibit A .
(d) Prior
to the earlier of (i) the date on which this Agreement is
terminated and (ii) the Closing Date, the Company shall not,
without the prior written consent of the Placement Agent, solicit
or accept offers to purchase Securities of the Company (other than
pursuant to the exercise of options or warrants to purchase shares
of Common Stock that are outstanding at the date hereof) otherwise
than through the Placement Agent in accordance herewith.
(e) No
Securities which the Company has agreed to sell pursuant to this
Agreement and the Subscription Agreements 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 purchasing
such Securities against payment therefor by such
Investor. If the Company shall default in its
obligations to deliver Securities to an Investor whose offer it has
accepted, the Company shall indemnify and hold the Placement Agent
harmless against any loss, claim, damage or liability directly or
indirectly arising from or as a result of such default by the
Company in accordance with the procedures set forth in Section
6(c) hereof.
(f) Payment
of the purchase price for, and delivery of the Securities shall be
made at a closing (the “ Closing ”) at the
offices of Hughes Hubbard & Reed LLP, counsel for the Company,
located at One Battery Park Plaza, New York, New York, at 10:00
a.m., local time, on June 15, 2009 or at such other time and date
as the Placement Agent and the Company determine pursuant to Rule
15c6-1(a) under the Securities Exchange Act of 1934, as amended
(the “ Exchange Act ”)(such date of payment and
delivery being herein referred to as the “ Closing
Date ”). The Shares will be settled through
the facilities of The Depository Trust Company’s DWAC system
and the Warrants will be issued in registered physical
form. The Placement Agent shall facilitate the payment
of the purchase price for the Securities directly to the Company by
Federal Funds wire transfer from one or more accounts of the
Investors maintained by the Placement Agent, against delivery of
the Securities to such persons and shall be registered in the name
or names and shall be in such denominations as the Placement Agent
may request at least one business day before the Closing
Date. At least one business day prior to the Closing
Date, the Placement Agent shall submit to the Company its expense
reimbursement invoice pursuant to
Section 4
hereof and the Company agrees to reimburse the Placement Agent such
amount to which the Placement Agent is entitled thereunder within
thirty days of receipt of such invoice.
2.
Representations and Warranties of the Company . The
Company represents and warrants to the Placement Agent as of the
date hereof, and as of the Closing Date and agrees with the
Placement Agent, as follows:
(a)
Filing of Registration Statement . The Company has prepared
and filed, in conformity with the requirements of the Securities
Act of 1933, as amended (the “ Securities Act
”), and the published rules and regulations thereunder (the
“ Rules and Regulations ”) adopted by the
Securities and Exchange Commission (the “ Commission
”), a registration statement, including a prospectus, on Form
S-3 (File No. 333-143280), which became effective as of June 7,
2007, relating to the Securities and the offering thereof (the
“ Offering ”) from time to time in accordance
with Rule 415(a)(1)(x) of the Rules and Regulations, and such
amendments thereof as may have been required to the date of this
Agreement. The term “ Registration Statement ”
as used in this Agreement means the aforementioned registration
statement, as amended at the time of such registration
statement’s effectiveness for purposes of Section 11 of the
Securities Act, as such section applies to the Placement Agent (the
“ Effective Time ”), including (i) all documents
filed as a part thereof or incorporated or deemed to be
incorporated by reference therein and (ii) any information in the
corresponding Base Prospectus (as defined below) or a prospectus
supplement filed with the Commission pursuant to Rule 424(b) under
the Securities Act, to the extent such information is deemed
pursuant to Rule 430A (“ Rule 430A ”), 430B
(“ Rule 430B ”) or 430C (“
Rule 430C ”) under the Securities Act to be a
part thereof at the Effective Time. If the Company has filed an
abbreviated registration statement to register additional
Securities pursuant to Rule 462(b) under the Rules and Regulations
(the “ Rule 462(b) Registration Statement ”),
then any reference herein to the term “ Registration
Statement ” shall also be deemed to include such Rule
462(b) Registration Statement. For purposes of this Agreement, all
references to the Registration Statement, the Base Prospectus, any
Preliminary Prospectus (as defined below), the Prospectus (as
defined in below) or any amendment or supplement to any of the
foregoing shall be deemed to include the copy filed with the
Commission pursuant to its Electronic Data Gathering, Analysis and
Retrieval System (“ EDGAR ”). All references in
this Agreement to amendments or supplements to the Registration
Statement, the Base Prospectus, any Preliminary Prospectus or the
Prospectus shall be deemed to mean and include the subsequent
filing of any document under the Exchange Act and which is deemed
to be incorporated therein by reference therein or otherwise deemed
to be a part thereof.
(b)
Effectiveness of Registration Statement; Certain Defined
Terms . The Company and the transactions contemplated by this
Agreement meet the requirements and comply with the conditions for
the use of Form S-3 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 preventing or suspending use of the Registration
Statement, any Preliminary Prospectus or the Prospectus or the
effectiveness of the Registration Statement has been issued by the
Commission, and no proceedings for such purpose pursuant to Section
8A of the Securities Act against the Company or related to the
Offering have been instituted or are pending or, to the
Company’s knowledge, are contemplated or threatened by the
Commission, and any request received by the Company on the part of
the Commission for additional information has been complied with.
As used in this Agreement:
(1) “
Base Prospectus ” means the prospectus included in the
Registration Statement at the Effective Time.
(2) “
Disclosure Package ” means (i) the Statutory
Prospectus, (ii) each Issuer Free Writing Prospectus, if any, filed
or used by the Company on or before the Effective Time and listed
on Schedule I hereto (other than a roadshow that is an
Issuer Free Writing Prospectus but is not required to be filed
under Rule 433 of the Rules and Regulations) and (iii) the pricing
and other information as set forth on Exhibit G hereto, all
considered together.
(3) “
Issuer Free Writing Prospectus ” means any
“issuer free writing prospectus , ” as defined
in Rule 433 of the Rules and Regulations 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) of the Rules and
Regulations.
(4) “
Preliminary Prospectus ” means any preliminary
prospectus supplement, subject to completion, relating to the
Securities, filed by the Company with the Commission pursuant to
Rule 424(b) under the Securities Act for use in connection with the
offering and sale of the Securities, together with the Base
Prospectus attached to or used with such preliminary prospectus
supplement.
(5) “
Prospectus ” means the final prospectus supplement,
relating to the Securities, filed by the Company with the
Commission pursuant to Rule 424(b) under the Securities Act on or
before the second business day after the date hereof (or such
earlier time as may be required under the Securities Act), in the
form furnished by the Company to the Placement Agent, for use in
connection with the offering and sale of the Securities that
discloses the public offering price and other final terms of the
Securities, together with the Base Prospectus attached to or used
with such final prospectus supplement.
(6) “
Statutory Prospectus ” means the Preliminary
Prospectus, if any, and the Base Prospectus, each as amended and
supplemented immediately prior to the Time of Sale, including any
document incorporated by reference therein and any prospectus
supplement deemed to be a part thereof.
(7)
“Time of Sale” means 7:00 p.m., New York City
time, on the date of this Agreement.
(c)
Contents of Registration Statement . The Registration
Statement complied when it became effective, complies as of the
date hereof and, as amended or supplemented, at the Time of Sale
and at all times during which a prospectus is required by the
Securities Act to be delivered (whether physically or through
compliance with Rule 172 under the Securities Act or any similar
rule) in connection with any sale of Securities (the “
Prospectus Delivery Period ”), will comply, in all
material respects, with the requirements of the Securities Act and
the Rules and Regulations; the Registration Statement did not, as
of the Effective Time, contain an untrue statement of a material
fact or omit to state a material fact required to be stated therein
or necessary in order to make the statements therein not
misleading, provided , that the Company makes no
representation or warranty in this paragraph with respect to
statements in or omissions from the Registration Statement in
reliance upon, and in conformity with, written information
furnished to the Company by the Placement Agent specifically for
inclusion therein, which information the parties hereto agree is
limited to the Placement Agent’s Information (as defined in
Section 7 hereof).
(d)
Contents of Prospectus . The Prospectus will comply, as of
the date that it is filed with the Commission, the date of its
delivery to Investors and at all times during the Prospectus
Delivery Period, in all material respects, with the requirements of
the Securities Act; at no time during the period that begins on the
date the Prospectus is filed with the Commission and ends at the
end of the Prospectus Delivery Period will the Prospectus, as then
amended or supplemented, include an 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, provided , that the
Company makes no representation or warranty with respect to
statements in or omissions from the Prospectus in reliance upon,
and in conformity with, written information furnished to the
Company by the Placement Agent specifically for inclusion therein,
which information the parties hereto agree is limited to the
Placement Agent’s Information.
(e)
Incorporated Documents . Each of the documents incorporated
or deemed to be incorporated by reference in the Registration
Statement, at the time such document was filed with the Commission
or at the time such document became effective, as applicable,
complied, in all material respects, with the requirements of the
Exchange Act, were filed on a timely basis with the Commission and
did not include an 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.
(f)
Disclosure Package . The Disclosure Package, as of the Time
of Sale, did not, and at the Closing Date will not, contain any
untrue statement of a material fact or omit to state any material
fact required to be stated therein or necessary in order to make
the statements therein, in the light of the circumstances under
which they were made, not misleading; provided , that the
Company makes no representations or warranty in this paragraph with
respect to statements in or omissions from the Disclosure Package
in reliance upon, and in conformity with, written information
furnished to the Company by the Placement Agent specifically for
inclusion therein, which information the parties hereto agree is
limited to the Placement Agent’s Information.
(g)
Distributed Materials; Conflict with Registration Statement
. Other than the Base Prospectus, any Preliminary Prospectus and
the Prospectus, the Company has not made, used, prepared,
authorized, approved or referred to and will not make, use,
prepare, authorize, approve or refer to any “written
communication” (as defined in Rule 405 under the Securities
Act) that constitutes an offer to sell or a solicitation of an
offer to buy the Securities other than (i) any document not
constituting a prospectus pursuant to Section 2(a)(10)(a) of the
Securities Act or Rule 134 under the Securities Act or (ii) the
documents listed on Schedule I hereto and other written
communications approved in advance by the Placement
Agent.
(h)
Issuer Free Writing Prospectuses . Each Issuer Free Writing
Prospectus, if any, conformed or will conform in all material
respects to the requirements of the Securities Act and the Rules
and Regulations on the date of first use, and the Company has
complied or will comply with any filing requirements applicable to
such Issuer Free Writing Prospectus pursuant to the Rules and
Regulations. Each Issuer Free Writing Prospectus, if any, when
considered together with the Disclosure Package, as of its issue
date and at all subsequent times through the completion of the
Prospectus Delivery Period 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
Statutory Prospectus or the Prospectus, including any document
incorporated by reference therein and any prospectus supplement
deemed to be a part thereof that has not been superseded or
modified, or includes an untrue statement of a material fact or
omitted
or would omit
to state a material fact required to be stated therein or necessary
in order to make the statements therein, in the light of the
circumstances prevailing at the subsequent time, not misleading;
provided , that the Company makes no representation or
warranty with respect 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 Agent
specifically for inclusion therein, which information the parties
hereto agree is limited to the Placement Agent’s
Information.
(i)
Not an Ineligible Issuer . (1) At the earliest time after
the filing of the Registration Statement that the Company or
another offering participant made a bona fide offer (within the
meaning of Rule 164(h)(2) under the Securities Act) of the
Securities and (2) at the date hereof, the Company was not and is
not an “ineligible issuer,” as defined in Rule 405
(“ Rule 405 ”) under the Securities
Act.
(j)
Due Incorporation . 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 the corporate power and
authority to own its properties and to conduct its business as
currently being conducted and as described in the Registration
Statement, the Prospectus and the Disclosure Package. The Company
is duly qualified to transact business and is in good standing as a
foreign corporation or other legal entity in each other
jurisdiction in which its ownership or leasing of property or the
conduct of its business requires such qualification, except where
the failure to be so qualified and in good standing or have such
power or authority (i) would not have, individually or in the
aggregate, a material adverse effect upon, the general affairs,
business, operations, prospects, properties, financial condition,
or results of operations of the Company, taken as a whole, or (ii)
impair in any material respect the power or ability of the Company
to perform its obligations under this Agreement or to consummate
any transactions contemplated by the Agreement and the Subscription
Agreements, including the issuance and sale of the Securities (any
such effect as described in clauses (i) or (ii), a “
Material Adverse Effect ”).
(k)
Subsidiaries . The Company has no subsidiaries and does not
own any beneficial interest, directly or indirectly, in any
corporation, partnership, joint venture or other business
entity.
(l)
Due Authorization and Enforceability . The Company has the
full right, power and authority to enter into this Agreement and
each of the Subscription Agreements, and to perform and discharge
its obligations hereunder and thereunder; and each of this
Agreement and each Subscription Agreement has been duly authorized,
executed and delivered by the Company, and constitutes a valid,
legal and binding obligation of the Company, enforceable against
the Company in accordance with its terms, except as rights to
indemnity hereunder may be limited by federal or state securities
laws and except as such enforceability may be limited by applicable
bankruptcy, insolvency, reorganization or similar laws affecting
the rights of creditors generally and subject to general principles
of equity.
(m)
The Securities . The issuance of the Shares has been duly
and validly authorized by the Company and, when issued, delivered
and paid for in accordance with the terms of this Agreement and the
Subscription Agreements, will have been duly and validly issued and
will be fully paid and nonassessable, will not be subject to any
statutory or contractual preemptive rights or other rights to
subscribe for or purchase or acquire any shares of Common Stock of
the Company, which have not been waived or complied with and will
conform in all material respects to the description thereof
contained in the Disclosure Package and the Prospectus and
such
description
conforms in all material respects to the rights set forth in the
instruments defining the same. The Warrants conform, or when issued
will conform, to the description thereof contained in the
Disclosure Package and the Prospectus and have been duly and
validly authorized by the Company and upon delivery to the
Investors at the Closing Date will be valid and binding obligations
of the Company, enforceable in accordance with their terms, except
as such enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar laws affecting the rights and
remedies of creditors generally or subject to general principles of
equity. The Warrant Shares initially issuable upon exercise of the
Warrants have been duly and validly authorized and reserved for
issuance by the Company and when issued, delivered and paid for in
accordance with the terms thereof, will have been duly and validly
issued and will be fully paid and nonassessable and will not be
subject to any statutory or contractual preemptive rights or other
rights to subscribe for or to purchase or acquire any shares of
Common Stock of the Company which have not been waived or complied
with.
(n)
Capitalization . The information set forth under the caption
“Capitalization” in the Statutory Prospectus (and any
similar sections or information, if any, contained in the
Disclosure Package) is fairly presented on a basis consistent with
the Company’s financial statements. The authorized capital
stock of the Company conforms as to legal matters to the
description thereof contained in the Prospectus under the caption
“Description of Capital Stock” (and any similar
sections or information, if any, contained in the Disclosure
Package). The issued and outstanding shares of capital stock of the
Company have been duly authorized and validly issued, are fully
paid and nonassessable, and have been issued in compliance with all
federal and state securities laws. None of the outstanding shares
of Common Stock was issued in violation of any preemptive rights,
rights of first refusal or other similar rights to subscribe for or
purchase or acquire any securities of the Company. There are no
authorized or outstanding shares of capital stock, options,
warrants, preemptive rights, rights of first refusal or other
rights to purchase, or equity or debt securities convertible into
or exchangeable for, any capital stock of the Company other than
those described in the Prospectus and the Disclosure Package. The
description of the Company’s stock option, stock bonus and
other stock plans or arrangements, and the options or other rights
granted thereunder, as described in the Prospectus and the
Disclosure Package, accurately and fairly present the information
required to be shown with respect to such plans, arrangements,
options and rights.
(o)
No Conflict . The execution, delivery and performance by the
Company of this Agreement and the Subscription Agreements and the
consummation of the transactions contemplated hereby and thereby,
including the issuance and sale by the Company of the Securities
and the issuance of the Warrant Shares upon due exercise of the
Warrants in accordance with their terms, will not conflict with or
result in a breach or violation of, or constitute a default under
(nor constitute any event which with notice, lapse of time or both
would result in any breach or violation of or constitute a default
under), give rise to any right of termination or other right or the
cancellation or acceleration of any right or obligation or loss of
a benefit under, or give rise to the creation or imposition of any
lien, encumbrance, security interest, claim or charge upon any
property or assets of the Company pursuant to (i) any indenture,
mortgage, deed of trust, loan agreement or other agreement or
instrument to which the Company is a party or by which any of them
or any of their respective properties may be bound or to which any
of the property or assets of the Company is subject, (ii) result in
any violation of the provisions of the charter or by-laws of the
Company, or (iii) result in any violation of any law, statute,
rule, regulation, judgment, order or decree of any court or
governmental agency or body, domestic or foreign, having
jurisdiction over the Company or any of their properties or
assets.
(p)
No Consents Required . No approval, authorization, consent
or order of or filing, qualification or registration with, any
court or governmental agency or body, foreign or domestic, which
has not been made, obtained or taken and is not in full force and
effect, is required in connection with the execution, delivery and
performance of this Agreement and the Subscription Agreements by
the Company, the issuance and sale of the Securities and the
issuance of the Warrant Shares upon due exercise of the Warrants in
accordance with their terms or the consummation by the Company of
the transactions contemplated hereby or thereby other than
(i) as may be required under the Securities Act, (ii) any
necessary qualification of the Securities under the securities or
blue sky laws of the various jurisdictions in which the Securities
are being offered by the Placement Agent, (iii) under the
rules and regulations of the Financial Industry Regulatory
Authority (“ FINRA ”) or (iv) the NASDAQ Capital
Market in connection with the distribution of the Securities by the
Placement Agent.
(q)
Preemptive Rights . Except as otherwise described in the
Registration Statement, the Prospectus and the Disclosure Package,
there are no preemptive rights or other rights (other than rights
which have been waived in writing in connection with the
transactions contemplated by this Agreement or otherwise satisfied)
to subscribe for or to purchase any shares of Common Stock or
shares of any other capital stock or other equity interests of the
Company, or any agreement or arrangement between the Company and
any of the Company’s stockholders, or to the Company’s
knowledge, between or among any of the Company’s
stockholders, which grant special rights with respect to any shares
of the Company’s capital stock or which in any way affect any
stockholder’s ability or right freely to alienate or vote
such shares.
(r)
Registration Rights . Except as otherwise described in the
Registration Statement, the Prospectus and the Disclosure Package,
there are no contracts, agreements or understandings between the
Company and any person granting such person the right (other than
rights which have been waived in writing in connection with the
transactions contemplated by this Agreement or otherwise satisfied)
to require the Company to register any securities with the
Commission.
(s)
Lock-Up Agreements . The Company has received copies of the
executed Lock-Up Agreements, substantially in the form of
Exhibit C hereto (the “ Lock-Up Agreement
”) executed by each person listed on Exhibit D hereto,
and such Lock-Up Agreements shall be in full force and effect on
the Closing Date.
(t)
Independent Accountants . Carlin, Charron & Rosen, LLP
(“ CCR LLP ”), whose reports on the consolidated
financial statements of the Company are incorporated by reference
in the Registration Statement, the Prospectus and the Disclosure
Package, is (i) an independent public accounting firm within the
meaning of the Securities Act, (ii) a registered public accounting
firm (as defined in Section 2(a)(12) of the Sarbanes-Oxley Act of
2002 (the “ Sarbanes-Oxley Act ”)), and (iii) to
the Company’s knowledge, not in violation of the auditor
independence requirements of the Sarbanes-Oxley Act.
(u)
Financial Statements . The financial statements of the
Company, together with the related schedules and notes thereto, set
forth or incorporated by reference in the Registration Statement,
the Prospectus and the Disclosure Package, comply in all material
respects with the applicable requirements of the Securities Act and
the Exchange Act, as applicable, and present fairly in all material
respects (i) the financial condition of the Company as of the dates
indicated and (ii) the consolidated results of operations,
stockholders’ equity and changes in cash flows of the Company
for the periods therein specified; and such financial statements
and related schedules and notes thereto have been prepared in
conformity with United States generally
accepted
accounting principles, consistently applied throughout the periods
involved (except as otherwise stated therein and subject, in the
case of unaudited financial statements, to the absence of footnotes
and normal year-end adjustments). There are no other financial
statements (historical or pro forma) that are required to be
included or incorporated by reference in the Registration
Statement, the Prospectus or the Disclosure Package; and the
Company does not have any material liabilities or obligations,
direct or contingent (including any off-balance sheet obligations),
not disclosed in the Registration Statement, the Disclosure Package
and the Prospectus; and all disclosures contained in the
Registration Statement, the Disclosure Package and the Prospectus
regarding “non-GAAP financial measures” (as such term
is defined by the rules and regulations of the Commission) comply
with Regulation G of the Exchange Act and Item 10(e) of Regulation
S-K under the Securities Act, to the extent applicable, and present
fairly the information shown therein and the Company’s basis
for using such measures.
(v)
Absence of Material Changes . Subsequent to the respective
dates as of which information is given in the Registration
Statement, the Prospectus and the Disclosure Package, and except as
may be otherwise stated or incorporated by reference in the
Registration Statement, the Prospectus and the Disclosure Package,
there has not been (i) any Material Adverse Effect, (ii) any
transaction which is material to the Company, (iii) any obligation,
direct or contingent (including any off-balance sheet obligations),
incurred by the Company, which is material to the Company, (iv) any
dividend or distribution of any kind declared, paid or made on the
capital stock of the Company, (v) any change in the capital stock
(other than a change in the number of outstanding shares of Common
Stock due to the issuance of shares upon the exercise of
outstanding options or warrants or the conversion of convertible
indebtedness), or material change in the short-term debt or
long-term debt of the Company (other than upon conversion of
convertible indebtedness) or any issuance of options, warrants,
convertible securities or other rights to purchase the capital
stock (other than grants of stock options under the Company’s
stock option plans existing on the date hereof) of the
Company.
(w)
Legal Proceedings . There are no legal or governmental
actions, suits, claims or proceedings pending or, to the
Company’s knowledge, threatened or contemplated to which the
Company is or would be a party or of which any of their respective
properties is or would be subject at law or in equity, before or by
any federal, state, local or foreign governmental or regulatory
commission, board, body, authority or agency, or before or by any
self-regulatory organization or other non-governmental regulatory
authority (including, without limitation, the Food and Drug
Administration of the U.S. Department of Health and Human Services
(the “ FDA ”)) which are required to be
described in the Registration Statement, the Disclosure Package or
the Prospectus or a document incorporated by reference therein and
are not so described therein, or which, singularly or in the
aggregate, if resolved adversely to the Company, would reasonably
be likely to result in a Material Adverse Effect or prevent or
materially and adversely affect the ability of the Company to
consummate the transactions contemplated hereby. To the
Company’s knowledge, no such proceedings are threatened or
contemplated by governmental authorities or threatened by
others.
(x)
No Violation . The Company is not in breach or violation of
or in default (nor has any event occurred which with notice, lapse
of time or both would result in any breach or violation of, or
constitute a default) (i) under the provisions of its charter or
bylaws (or analogous governing instrument, as applicable) or
(ii) in the performance or observance of any term, covenant,
obligation, agreement or condition contained in any indenture,
mortgage, deed of trust, bank loan or credit agreement or other
evidence of indebtedness, or any license, lease, contract or other
agreement or instrument to which the Company is a party or by which
any of them or any of
their
properties may be bound or affected, or (iii) in the performance or
observance of any statute, law, rule, regulation, ordinance,
judgment, order or decree of any court, regulatory body,
administrative agency, governmental body, arbitrator or other
authority having jurisdiction over the Company or any of its
properties, as applicable (including, without limitation, those
administered by the FDA or by any foreign, federal, state or local
governmental or regulatory authority performing functions similar
to those performed by the FDA), except, with respect to clauses
(ii) and (iii) above, to the extent any such contravention has been
waived or would not result in a Material Adverse Effect.
(y)
Permits . The Company has made all filings, applications and
submissions required by, and owns or possesses all approvals,
licenses, certificates, certifications, clearances, consents,
exemptions, marks, notifications, orders, permits and other
authorizations issued by, the appropriate federal, state or foreign
regulatory authorities (including, without limitation, the FDA, and
any other foreign, federal state or local government or regulatory
authorities performing functions similar to those performed by the
FDA) necessary to conduct its business as described in the
Disclosure Package (collectively, “ Permits ”),
except for such Permits which the failure to obtain would not have
a Material Adverse Effect (the “ Immaterial Permits
”), and is in compliance in all material respects with the
terms and conditions of all such Permits other than the Immaterial
Permits (the “ Required Permits ”). All such
Required Permits held by the Company are valid and in full force
and effect. The Company has not received any notice of any
proceedings relating to revocation or modification of, any such
Required Permit, which, individually or in the aggregate, if the
subject of an unfavorable decision, ruling or finding, would have a
Material Adverse Effect.
(z)
Not an Investment Company . The Company is not or, after
giving effect to the offering and sale of the Securities and the
application of the proceeds thereof as described in the Disclosure
Package and the Prospectus, will not be (i) required to register as
an “investment company” as defined in the Investment
Company Act of 1940, as amended (the “ Investment Company
Act” ), and the rules and regulations of the Commission
thereunder or (ii) a “business development
company” (as defined in Section 2(a)(48) of the
Investment Company Act).
(aa)
No Price Stabilization . Neither the Company nor, to the
Company’s knowledge, any of its officers, directors,
affiliates or controlling persons has taken or will take, directly
or indirectly, any action designed to or that might be reasonably
expected 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 any security of the Company to
facilitate the sale or resale of the Securities.
(bb)
Good Title to Property . The Company has good and valid
title to all property (whether real or personal) described in the
Registration Statement, the Disclosure Package and the Prospectus
as being owned by it, in each case free and clear of all liens,
claims, security interests, other encumbrances or defects
(collectively, “ Liens ”), except such as are
described in the Registration Statement, the Disclosure Package and
the Prospectus and those that would not, individually or in the
aggregate materially affect the value of such property and do not
materially interfere with the use made and proposed to be made of
such property by the Company. All of the property described in the
Registration Statement, Disclosure Package and the Prospectus as
being held under lease by the Company is held thereby under valid,
subsisting and enforceable leases, without any liens, restrictions,
encumbrances or claims, except those that, individually or in
the aggregate, are not material and do not materially interfere
with the use made and proposed to be made of such property by the
Company.
(cc)
Intellectual Property Rights . The Company owns or possesses
the right to use all patents, trademarks, trademark registrations,
service marks, service mark registrations, trade names, copyrights,
licenses, inventions, software, databases, know-how, Internet
domain names, trade secrets and other unpatented and/or
unpatentable proprietary or confidential information, systems or
procedures, and other intellectual property (collectively, “
Intellectual Property ”) necessary to carry on their
respective businesses as currently conducted, and as proposed to be
conducted and described in the Disclosure Package and the
Prospectus, and the Company is not aware of any claim to the
contrary or any challenge by any other person to the rights of the
Company with respect to the foregoing except for those that could
not have a Material Adverse Effect. The Intellectual Property
licenses described in the Disclosure Package and the Prospectus
are, to the knowledge of the Company, valid, binding upon, and
enforceable by or against the parties thereto in accordance to
their terms. The Company has complied in all material respects
with, and is not in breach nor has received any asserted or
threatened claim of breach of, any Intellectual Property license,
and the Company has no knowledge of any breach or anticipated
breach by any other person to any Intellectual Property license.
The Company’s businesses as now conducted and as proposed to
be conducted, to the knowledge of the Company, do not and will not
infringe or conflict with any patents, trademarks, service marks,
trade names, copyrights, trade secrets, licenses or other
Intellectual Property or franchise right of any person. The Company
has not received notice of any material claim against the Company
alleging the infringement by the Company of any patent, trademark,
service mark, trade name, copyright, trade secret, license in or
other intellectual property right or franchise right of any person.
The Company has taken all reasonable steps to protect, maintain and
safeguard its rights in all Intellectual Property, including the
execution of appropriate nondisclosure and confidentiality
agreements. The consummation of the transactions contemplated by
this Agreement will not result in the loss or impairment of or
payment of any additional amounts with respect to, nor require the
consent of any other person in respect of, the Company’s
right to own, use, or hold for use any of the Intellectual Property
as owned, used or held for use in the conduct of the businesses as
currently conducted. The Company has duly and properly filed or
caused to be filed with the United States Patent and Trademark
Office (the “ PTO ”) and applicable foreign and
international patent authorities all patent applications owned by
the Company (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. The Company is not aware of any
information material to a determination of patentability regarding
the Company Patent Applications not called to the attention of the
PTO or similar foreign authority. The Company is not aware of any
information not called to the attention of the PTO or similar
foreign authority that would preclude the grant of a patent for the
Company Patent Applications. The Company has no knowledge of any
information that would preclude the Company from having clear title
to the Company Patent Applications.
(dd)
No Labor Disputes . No labor problem or dispute with the
employees of the Company exists, or, to the Company’s
knowledge, is threatened or imminent, which would reasonably be
expected to result in a Material Adverse Effect. The Company is not
aware that any key employee or significant group of employees of
the Company plans to terminate employment with the Company. The
Company has not engaged in any unfair labor practice; except for
matters which would not, individually or in the aggregate, result
in a Material Adverse Effect, (i) there is (A) no unfair labor
practice complaint pending or, to the Company’s knowledge,
threatened against the Company before the National Labor Relations
Board, and no grievance or arbitration proceeding arising out of or
under collective bargaining agreements is pending or to the
Company’s knowledge, threatened, (B) no strike, labor
dispute, slowdown or stoppage pending or, to the Company’s
knowledge, threatened against the Company and (C) no
union
representation
dispute currently existing concerning the employees of the Company
and (ii) to the Company’s knowledge, (A) no union organizing
activities are currently taking place concerning the employees of
the Company and (B) there has been no violation of any federal,
state, local or foreign law relating to discrimination in the
hiring, promotion or pay of employees, any applicable wage or hour
laws or any provision of the Employee Retirement Income Security
Act of 1974 (“ ERISA ”) or the rules and
regulations promulgated thereunder concerning the employees of the
Company.
(ee)
Taxes . The Company has (i) timely filed all necessary
federal, state, local and foreign income and franchise tax returns
(or timely filed applicable extensions therefore) that have been
required to be filed and (ii) are not in default in the payment of
any taxes which were payable pursuant to said returns or any
assessments with respect thereto, other than any which the Company
is contesting in good faith and for which adequate reserves have
been provided and reflected in the Company’s financial
statements included in the Registration Statement, the Disclosure
Package and the Prospectus. The Company does not have any tax
deficiency that has been or, to the knowledge of the Company, is
reasonably likely to be asserted or threatened against it that
would result in a Material Adverse Effect.
(ff)
ERISA . The Company is in compliance in all material
respects with all presently applicable provisions of ERISA; no
“reportable event” (as defined in ERISA) has occurred
with respect to any “pension plan” (as defined in
ERISA) for which the Company would have any liability; the Company
has not incurred and does not expect to incur liability under (i)
Title IV of ERISA with respect to termination of, or withdrawal
from, any “pension plan” or (ii) Sections 412 or 4971
of the Internal Revenue Code of 1986, as amended, including the
regulations and published interpretations thereunder (the “
Code ”); and each “pension plan” for which
the Company would have any liability that is intended to be
qualified under Section 401(a) of the Code is so qualified in all
material respects and nothing has occurred, whether by action or by
failure to act, which would cause the loss of such
qualification.
(gg)
Compliance with Environmental Laws . The Company (i) is in
compliance with any and all applicable foreign, federal, state and
local laws, orders, rules, regulations, directives, decrees and
judgments relating to the use, treatment, storage and disposal of
hazardous or toxic substances or waste and protection of human
health and safety or the environment which are applicable to their
businesses (“ Environmental Laws ”), (ii) has
received and is in compliance with all permits, licenses or other
approvals required of them under applicable Environmental Laws to
conduct its business; and (iii) is in compliance with all terms and
conditions of any such permit, license or approval, except where
such noncompliance with Environmental Laws, failure to receive
required permits, licenses or other approvals or failure to comply
with the terms and conditions of such permits, licenses or
approvals would not, individually or in the aggregate, result in a
Material Adverse Effect. There are no costs or liabilities
associated with Environmental Laws (including, without limitation,
any capital or operating expenditures required for clean-up,
closure of properties or compliance with Environmental Laws or any
permit, license or approval, any related constraints on operating
activities and any potential liabilities to third parties) which
would, individually or in the aggregate, result in a Material
Adverse Effect.
(hh)
Insurance . The Company maintains or is covered by insurance
provided by recognized, financially sound and reputable
institutions with insurance policies in such amounts and covering
such risks as is adequate for the conduct of its business and the
value of its properties and as is customary for companies engaged
in similar businesses in similar industries.
All such
insurance is fully in force on the date hereof and will be fully in
force as of the Closing Date. 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.
(ii)
Accounting Controls . 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 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.
(jj)
Disclosure Controls . The Company has established, maintains
and evaluates “disclosure controls and procedures” (as
such term is defined in Rule 13a-15(e) and 15d-15(e) under the
Exchange Act), which (i) are designed to ensure that material
information relating to the Company is made known to the
Company’s principal executive officer and its principal
financial officer by others within those entities, particularly
during the periods in which the periodic reports required under the
Exchange Act are being prepared, (ii) have been evaluated for
effectiveness as of the end of the last fiscal period covered by
the Registration Statement; and (iii) such disclosure controls and
procedures are effective in all material respects to perform the
functions for which they were established. There are no significant
deficiencies and material weaknesses in the design or operation of
internal controls which could adversely affect the Company’s
ability to record, process, summarize, and report financial data to
management and the Board of Directors of the Company. The Company
is not aware of any fraud, whether or not material, that involves
management or other employees who have a role in the
Company’s internal controls; and since the date of the most
recent evaluation of such disclosure controls and procedures, there
have been no significant changes in internal controls or in other
f
|