Exhibit 10.43
DYNAVAX TECHNOLOGIES
CORPORATION
EQUITY DISTRIBUTION
AGREEMENT
August 17, 2009
Wedbush Morgan Securities,
Inc.
One Bush Street, Suite 1700
San Francisco, California 94104
Ladies and Gentlemen:
1. Introductory
. Dynavax Technologies Corporation, a Delaware corporation
(the “ Company ”), proposes, subject to the
terms and conditions stated herein, to issue and sell through or to
Wedbush Morgan Securities, Inc., as sales agent or principal
(“ Wedbush ”), on the terms and subject to the
conditions of this Equity Distribution Agreement (this “
Agreement ”), shares of its authorized but unissued
common stock, par value $0.001 per share, having an aggregate gross
sales price of up to $15 million (the “ Shares
”). The shares of common stock, par value $0.001 per share,
of the Company to be outstanding after giving effect to the sales
contemplated hereby are hereinafter referred to as the “
Common Stock ”.
The Company and Wedbush hereby
confirm their agreement with respect to the issuance and sale of
the Shares as follows:
2. Registration Statement and
Prospectus . The Company has filed with the
Securities and Exchange Commission (the “ Commission
”) a registration statement on Form S-3 (File
No. 333-137608) under the Securities Act of 1933, as amended
(the “ Act ”), and the rules and regulations of
the Commission thereunder, and such amendments thereto (including
post-effective amendments) as may be required to the date of this
Agreement. Such registration statement, as amended (including any
post-effective amendments), has been declared effective by the
Commission. The registration statement as of its most recent
effective date, including the information (if any) deemed to be
part of the registration statement at the time of effectiveness
pursuant to Rule 430A or Rule 430B under the Act, is hereinafter
referred to as the “ Registration Statement ”,
and the related base prospectus dated October 3, 2006 and
filed as part of the Registration Statement, together with any
amendments or supplements thereto as of the most recent effective
date of the Registration Statement, is hereinafter referred to as
the “ Basic Prospectus. ” “ Prospectus
Supplement ” means the final prospectus supplement,
relating to the Shares, filed by the Company with the Commission
pursuant to Rule 424(b) under the Act on or before the second
business day after the date hereof, in the form furnished by the
Company to Wedbush in connection with the offering of the Shares.
Except where the context otherwise requires, “
Prospectus ” means the Basic Prospectus, as
supplemented by the Prospectus Supplement and the most recent
Interim Prospectus Supplement (as defined in Section 7(c)
below), if any. For purposes of this Agreement, “ free
writing prospectus ” has the meaning set forth in Rule
405 under the Act. “ Permitted Free Writing
Prospectuses ” means the documents listed on Schedule
I hereto. As used herein, the terms “ Registration
Statement ”, “ Basic Prospectus ”,
“ Prospectus Supplement ”, “ Interim
Prospectus Supplement ” and “ Prospectus
” shall include the documents, if any, incorporated by
reference therein. The terms “ supplement ”,
“ amendment ”, and “ amend ”
as used herein with respect to the Registration Statement, the
Basic Prospectus, the Prospectus Supplement, any Interim Prospectus
Supplement, the Prospectus or any free writing prospectus shall
include all documents subsequently filed by the Company with the
Commission pursuant to the Securities Exchange Act of 1934, as
amended (the “ Exchange Act ”), that are deemed
to be incorporated by reference therein (the “
Incorporated Documents ”).
3. Sale of Shares. On
the basis of the representations, warranties and agreements herein
contained, but subject to the terms and conditions herein set
forth, the Company and Wedbush agree that the Company may from time
to time seek to sell Shares through Wedbush, acting as sales agent,
or directly to Wedbush, acting as principal, as follows:
(a) The Company may submit its
orders to Wedbush by telephone (including any price, time or size
limits or other customary parameters or conditions) to sell Shares
on any Trading Day (as defined herein) which order shall be
confirmed by Wedbush (and accepted by the Company) by electronic
mail using a form substantially similar to that attached hereto as
Exhibit A . As used herein, “ Trading Day
” shall mean any trading day on the NASDAQ Capital Market
(the “ Exchange ”), other than a day on which
the Exchange is scheduled to close prior to its regular weekday
closing time.
(b) Subject to the terms and
conditions hereof, Wedbush shall use its commercially reasonable
efforts to execute any Company order submitted to it hereunder to
sell Shares and with respect to which Wedbush has agreed to act as
sales agent. The Company acknowledges and agrees that
(i) there can be no assurance that Wedbush will be successful
in selling the Shares, (ii) Wedbush will incur no liability or
obligation to the Company or any other person or entity if it does
not sell Shares for any reason and (iii) Wedbush shall be
under no obligation to purchase Shares on a principal basis
pursuant to this Agreement, except as otherwise specifically agreed
by Wedbush and the Company.
(c) Wedbush hereby covenants and
agrees not to make any sales of the Shares on behalf of the Company
other than as permitted by the terms of this Agreement.
(d) The Company shall not authorize
the issuance and sale of, and Wedbush shall not sell as sales
agent, any Share at a price lower than the minimum price therefor
designated by the Company pursuant to Section 3(a) above. In
addition, Wedbush or the Company may, upon notice to the other
party hereto by telephone (confirmed promptly by email or
facsimile), suspend an offering of the Shares with respect to which
Wedbush is acting as sales agent; provided, however, that such
suspension or termination shall not affect or impair the
parties’ respective obligations with respect to the Shares
sold hereunder prior to the giving of such notice.
(e) If acting as sales agent
hereunder, Wedbush shall provide written confirmation (which may be
by facsimile or email) to the Company following the close of
trading on the Exchange each day in which Shares are sold under
this Agreement setting forth (i) the amount of Shares sold on
such day, (ii) the gross offering proceeds received from such
sale and (iii) the commission payable by the Company to
Wedbush with respect to such sales.
(f) At each Time of Sale, Settlement
Date and Representation Date (as defined below), the Company shall
be deemed to have affirmed each representation and warranty
contained in this Agreement. Any obligation of Wedbush to use its
commercially reasonable efforts to sell the Shares on behalf of the
Company as sales agent shall be subject to the continuing accuracy
of the representations and warranties of the Company herein, to the
performance by the Company of its obligations hereunder and to the
continuing satisfaction of the additional conditions specified in
Section 9 of this Agreement.
(g) Notwithstanding any other
provision of this Agreement, the Company and Wedbush agree that no
sales of Shares shall take place, the Company shall not request the
sales of any Shares that would be sold and Wedbush shall not be
obligated to sell or offer to sell, during any period in which the
Company’s insider trading policy, as it exists on the date of
this Agreement,
2
would prohibit the purchase or sale
of Common Stock by persons subject to such policy, or during any
other period in which the Company is in possession of material
non-public information.
4. Fees and Expense
Reimbursement.
(a) The compensation to Wedbush for
sales of the Shares with respect to which Wedbush acts as sales
agent hereunder shall be equal to 4% of the gross offering proceeds
of the Shares sold pursuant to this Agreement. The Company may sell
Shares to Wedbush as principal at a price agreed upon at the
relevant Time of Sale.
(b) The Company shall from time to
time reimburse Wedbush for its reasonable out-of-pocket expenses,
including the reasonable fees and disbursements of counsel for
Wedbush, incurred by Wedbush in connection with the transactions
and other matters contemplated hereunder in an amount not to exceed
$125,000 in the aggregate.
5. Delivery and
Payment.
(a) Settlement for sales of the
Shares pursuant to this Agreement will occur on the third Trading
Day (or such earlier day as is industry practice for regular-way
trading) following the date on which such sales are made (each such
day, a “ Settlement Date ”). On each Settlement
Date, the Shares sold through or to Wedbush for settlement on such
date shall be issued and delivered by the Company to Wedbush
against payment of the net proceeds from the sale of such Shares.
Settlement for all such Shares shall be effected by free delivery
of the Shares by the Company or its transfer agent (i) to
Wedbush’s or its designee’s account (provided Wedbush
shall have given the Company written notice of such designee prior
to the Settlement Date) at The Depository Trust Company (“
DTC ”), (ii) through credit to the
purchaser’s balance account with DTC through its Deposit
Withdrawal Agent Commission system (provided Wedbush shall have
given the Company written notice of account information prior to
the Settlement Date), or (iii) by such other means of delivery
as may be mutually agreed upon by the parties hereto, which in all
cases shall be freely tradable, transferable, registered shares in
good deliverable form, in return for payment in same day funds
delivered to the account designated by the Company. If the Company,
or its transfer agent (if applicable), shall default on its
obligation to deliver the Shares on any Settlement Date, the
Company shall (i) hold Wedbush harmless against any loss,
claim, damage, or expense (including reasonable legal fees and
expenses), as incurred, arising out of or in connection with such
default by the Company and (ii) pay Wedbush any commission,
discount or other compensation to which it would otherwise be
entitled absent such default.
6. Representations and
Warranties of the Company. The Company represents and
warrants to, and agrees with, Wedbush that:
(a) Effectiveness of
Registration Statement . The Registration Statement has
become effective; no stop order suspending the effectiveness of the
Registration Statement is in effect, and no proceedings for such
purpose are pending before or threatened by the
Commission.
(b) Compliance with Act
Requirements. (i) (A) At the respective times the
Registration Statement and each amendment thereto became effective,
(B) at each deemed effective date with respect to Wedbush
pursuant to Rule 430B(f)(2) under the Act (each, a “
Deemed Effective Time ”), (C) as of each time
Shares are sold pursuant to this Agreement (each, a “ Time
of Sale ”), (D) at each Settlement Date (as defined
below) and (E) at all times during which a prospectus is
required by the Act to be delivered (whether physically or through
compliance with Rule 172 under the Act or any similar rule) in
connection with any sale of
3
Shares (the “ Delivery
Period ”), the Registration Statement complied and will
comply in all material respects with the requirements of the Act
and the rules and regulations under the Act; (ii) the Basic
Prospectus complied at the time it was filed with the Commission,
complies as of the date hereof and, as of each Time of Sale and at
all times during the Delivery Period, will comply in all material
respects with the rules and regulations under the Act;
(iii) each of the Prospectus Supplement, any Interim
Prospectus Supplement and the Prospectus will comply, as of the
date that it is filed with the Commission, as of each Time of Sale,
as of each Settlement Date and at all times during the Delivery
Period, in all material respects with the rules and regulations
under the Act and (iv) the Incorporated Documents, when they
were filed with the Commission, conformed in all material respects
to the requirements of the Exchange Act and the rules and
regulations of the Commission thereunder, and any further
Incorporated Documents so filed and incorporated by reference, when
they are filed with the Commission, will conform in all material
respects to the requirements of the Exchange Act and the rules and
regulations of the Commission thereunder.
(c) Absence of Material
Misstatements and Omissions. (i) As of the date
hereof, at the respective times the Registration Statement and each
amendment thereto became effective and at each Deemed Effective
Time, the Registration Statement did not and will not contain an
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; (ii) as of each Time of
Sale, the Prospectus (as amended and supplemented at such Time of
Sale) and any Permitted Free Writing Prospectus, considered
together (collectively, the “ General 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; (iii) as of its
date, the Prospectus did not contain 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; and (iv) at any
Settlement Date, the Prospectus (as amended and supplemented at
such Settlement Date) did not and will not contain 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, however, that this representation and warranty shall not
apply to any statements in or omissions from any such document
based upon written information furnished to the Company by Wedbush,
if any, specifically for use therein, it being understood and
agreed that the only such information is that described as such in
Section 9(b) hereof.
(d) Free Writing
Prospectuses. Any free writing prospectus that the Company
is required to file pursuant to Rule 433(d) under the Act has been,
or will be, filed with the Commission in accordance with the
requirements of the Act and the applicable rules and regulations of
the Commission thereunder. Each free writing prospectus that the
Company has filed, or is required to file, pursuant to Rule 433(d)
under the Act or that was prepared by or on behalf of or used or
referred to by the Company complies or will comply in all material
respects with the requirements of the Act and the applicable rules
and regulations of the Commission thereunder. Each free writing
prospectus, as of its issue date and at all subsequent times
through the completion of the public offer and sale of the Shares
or until any earlier date that the Company notified or notifies
Wedbush, did not, does not and will not include any material
information that conflicted, conflicts or will conflict with the
information contained in the Registration Statement or the
Prospectus. Except for the Permitted Free Writing Prospectuses, if
any, each furnished to Wedbush before first use, the Company has
not prepared, used or referred to, and will not, without
Wedbush’s prior consent, prepare, use or refer to, any free
writing prospectus.
4
(e) Not an “Ineligible
Issuer”. (A) (i) At the time of filing the
Registration Statement and (ii) at the time of the most recent
amendment thereto for the purposes of complying with
Section 10(a)(3) of the Act (whether such amendment was by
post-effective amendment, incorporated report filed pursuant to
Section 13 or 15(d) of the Exchange Act or form of
prospectus), the Company was not an “ineligible issuer”
as defined in Rule 405 of the Act; and (B) (i) at the
time of filing of the Registration Statement, (ii) at the
earliest time thereafter that the Company or another offering
participant made a bona fide offer (within the meaning of Rule
164(h)(2) under the Act) of the Shares and (iii) at the date
hereof, the Company was not and is not an “ineligible
issuer” as defined in Rule 405 under the Act.
(f) Shelf Registration
Statement. The date of this Agreement is not more than
three years subsequent to the initial effective date of the
Registration Statement.
(g) Good Standing of the
Company and Its Subsidiary. The Company and the subsidiary
of the Company listed on Schedule II attached hereto (the
“ Subsidiary ”) has been duly incorporated and
is existing and in good standing under the laws of their respective
jurisdictions of organization, with power and authority (corporate
and other) to own its respective properties and conduct its
respective business as disclosed in the General Disclosure Package;
and each of the Company and the Subsidiary is duly qualified to do
business as a foreign corporation in good standing in all other
jurisdictions in which its ownership or lease of property or the
conduct of its business requires such qualification, except to the
extent that the failure to be so qualified or be in good standing
would not materially and adversely affect the Company or the
Subsidiary or their respective businesses, properties, business
prospects, conditions (financial or other) or results of
operations, taken as a whole (such effect is referred to herein as
a “ Material Adverse Effect ”). Except for the
Subsidiary, the Company does not own any equity interest in any
other entity. Except as disclosed in the General Disclosure Package
and other than with respect to Symphony Dynamo, Inc., the Company
has no “variable interests” in “variable interest
entities,” as such terms are defined in Financial Accounting
Standards Board Interpretation No. 46.
(h) Exchange Act
Reports . The Company has filed in a timely manner
all reports required to be filed pursuant to Sections 13(a),
13(e), 14 and 15(d) of the Exchange Act during the preceding 12
months.
(i) Capital Stock. The
Shares to be issued and sold by the Company hereunder and all other
outstanding shares of capital stock of the Company have been duly
authorized; all outstanding shares of capital stock of the Company
are, and, when the Shares of Common Stock have been delivered and
paid for in accordance with this Agreement, such Shares will have
been, validly issued, fully paid and nonassessable, and such Shares
will conform to the information in the General Disclosure Package
and to the description of such Shares contained in the Prospectus;
the stockholders of the Company have no statutory or contractual
preemptive rights with respect to the Common Stock; none of the
outstanding shares of capital stock of the Company are or will have
been issued in violation of any statutory or contractual preemptive
rights of any security holder; and the authorized equity
capitalization of the Company is as set forth in the General
Disclosure Package. Except as disclosed in the General Disclosure
Package, the Company owns all of the outstanding capital stock of
the Subsidiary.
(j) No Finder’s
Fee. 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 Wedbush for a brokerage commission,
finder’s fee or other like payment.
5
(k) Financial
Statements . The financial statements and schedules
included or incorporated by reference in the Registration Statement
and the General Disclosure Package present fairly the financial
condition of the Company and its consolidated Subsidiary as of the
respective dates thereof and the results of operations and cash
flows of the Company and its consolidated Subsidiary for the
respective periods covered thereby, all in conformity with
generally accepted accounting principles applied on a consistent
basis throughout the entire period involved. No other financial
statements or schedules of the Company are required by the Act, the
Exchange Act, or the rules and regulations thereunder to be
included in the Registration Statement or the General Disclosure
Package. Ernst & Young LLP (the “ Accountant
”), who has reported on such financial statements and
schedules, is an independent accountant with respect to the Company
as required by the Act and the rules and regulations thereunder and
Rule 3600T of the Public Company Accounting Oversight Board.
The summary and selected consolidated financial and statistical
data, if any, included in or incorporated by reference into the
Registration Statement and the General Disclosure Package present
fairly the information shown therein and have been compiled on a
basis consistent with the Company’s audited financial
statements.
(l) Absence of
Changes. Subsequent to the respective dates as of which
information is given in the General Disclosure Package, except as
set forth in or contemplated by the General Disclosure Package,
(i) there has not been any change in the capitalization of the
Company (other than in connection with the grant or exercise of
awards or options to purchase the Common Stock granted pursuant to
the Company’s equity incentive plans from the shares reserved
therefor), (ii) any Material Adverse Effect arising for any
reason whatsoever, (iii) the Company has not incurred, except
in the ordinary course of business as disclosed in the General
Disclosure Package, any material liabilities or obligations, direct
or contingent, the Company has not entered into, except in the
ordinary course of business as disclosed in the General Disclosure
Package, any material transactions other than pursuant to this
Agreement and the transactions referred to herein and (iv) the
Company has not paid or declared any dividends or other
distributions of any kind on any class of its capital
stock.
(m) Not An Investment
Company . The Company is not, will not become as a result
of the transactions contemplated hereby, an “investment
company” or an “affiliated person” of, or
“promoter” or “principal underwriter” for,
an “investment company,” as such terms are defined in
the Investment Company Act of 1940, as amended.
(n) Litigation .
Except as disclosed in the General Disclosure Package, there are no
actions, suits or proceedings pending or, to the knowledge of the
Company, threatened against or affecting the Company or its
Subsidiary or against any of their respective officers in their
capacity as such, before or by any federal or state court,
commission, regulatory body, administrative agency or other
governmental body, domestic or foreign, wherein an unfavorable
ruling, decision or finding would reasonably be expected to have a
Material Adverse Effect.
(o) Absence of Existing
Defaults and Conflicts . Except as disclosed in the General
Disclosure Package, each of the Company and its Subsidiary is not
(i) in violation of any provision of their respective
certificates of incorporation or bylaws, (ii) in default in
any respect, and no event has occurred which, with notice or lapse
of time or both, would constitute such a default, in the due
performance or observance of any indenture, contract, lease,
mortgage, deed of trust, note agreement, loan agreement or other
agreement, obligation, condition, covenant or instrument to which
it is a party or by which it is bound or to which any of its
property or assets is subject, or (iii) in violation in any
respect of any statute, law, rule, regulation, ordinance, judgment,
order or decree of any court, regulatory body, administrative
agency, governmental body, arbitrator or other authority having
jurisdiction over the Company or the Subsidiary or any
6
of their respective properties, as
applicable, except, with respect to clauses (ii) and (iii),
any violations or defaults which, individually or in the aggregate,
would not reasonably be expected to have a Material Adverse
Effect.
(p) Absence of Further
Requirements . Except as disclosed in the General
Disclosure Package, no consent, approval, authorization or order
of, or any filing or declaration with, any court or governmental
agency or body is required for the consummation by the Company of
the transactions on its part contemplated herein, including the
offering and sale of the Shares, except such as have been obtained
under the Act or the rules and regulations thereunder and such as
may be required under state securities or Blue Sky laws.
(q) Authorization; Absence of
Defaults and Conflicts Resulting from Transaction . The
Company has full corporate power and authority to enter into this
Agreement. This Agreement has been duly authorized, executed and
delivered by the Company. This Agreement is a valid and binding
agreement of the Company, enforceable against the Company in
accordance with its terms. The performance of this Agreement and
the consummation of the transactions contemplated hereby, will not
(i) result in the creation or imposition of any lien, charge
or encumbrance upon any of the assets of the Company or the
Subsidiary pursuant to the terms or provisions of, or result in a
breach or violation of any of the terms or provisions of, or
conflict with or constitute a default under, or give any party a
right to terminate any of its obligations under, or result in the
acceleration of any obligation under, (A) the certificate of
incorporation or bylaws of the Company, or (B) any indenture,
mortgage, deed of trust, voting trust agreement, loan agreement,
bond, debenture, note agreement or other evidence of indebtedness,
lease, contract or other agreement or instrument to which the
Company or the Subsidiary is a party or by which the Company, the
Subsidiary or any of their respective properties is bound or
affected, except, in the case of clause (i)(B), any lien, breach,
violation, conflict, default or acceleration that would not,
individually or in the aggregate, reasonably be expected to have a
Material Adverse Effect, or (ii) violate or conflict with any
judgment, ruling, decree, order, statute, rule or regulation of any
court or other governmental agency or body applicable to the
business or properties of the Company or the Subsidiary except any
violation or conflict that would not, individually or in the
aggregate, reasonably be expected to have a Material Adverse
Effect.
(r) Title to Property
. Each of the Company and the Subsidiary has good and
marketable title to all properties and assets described in the
General Disclosure Package as owned by it, free and clear of all
liens, charges, encumbrances or restrictions, except such as are
described in the General Disclosure Package or are not material to
the business of the Company. Each of the Company and the Subsidiary
has valid, subsisting and enforceable leases for the properties
described in the General Disclosure Package as leased by it. Each
of the Company and the Subsidiary owns or leases all such
properties as are necessary to its respective operations as now
conducted or as proposed to be conducted, except where the failure
to so own or lease would not reasonably be expected to have a
Material Adverse Effect.
(s) Off Balance Sheet
Interests and Contracts . Except as disclosed in the
General Disclosure Package, there is no document, contract, permit
or instrument, affiliate transaction or off-balance sheet
transaction (including, without limitation, any “variable
interests” in “variable interest entities,” as
such terms are defined in Financial Accounting Standards Board
Interpretation No. 46) of a character required to be described
in the Registration Statement or the General Disclosure Package or
to be filed as an Exhibit to the Registration Statement that is not
described or filed as required. All such contracts described in the
immediately preceding sentence to which the Company or the
Subsidiary is a party have been duly authorized,
executed
7
and delivered by the Company or the
Subsidiary party thereto, constitute valid and binding agreements
of the Company or the Subsidiary party thereto and are enforceable
against and by the Company or the Subsidiary party thereto in
accordance with the terms thereof.
(t) Accuracy of
Statements . No statement, representation, warranty or
covenant made by the Company in this Agreement or made in any
certificate or document required by Section 9 of this
Agreement to be delivered to Wedbush was or will be, when made,
inaccurate, untrue or incorrect in any material respect.
(u) Offering Material;
Stabilization . The Company has not distributed, and will
not distribute, any offering material in connection with the
offering and sale of the Shares other than any the General
Disclosure Package, any Permitted Free Writing Prospectus, the
Prospectus, any Interim Prospectus Supplement, the Registration
Statement and other materials, if any, permitted by the Act.
Neither the Company nor any of its directors, officers or
controlling persons has taken, directly or indirectly, any action
designed, or that might reasonably be expected, to cause or result,
under the Act or otherwise, in, or that has constituted,
stabilization or manipulation of the price of any security of the
Company to facilitate the sale or resale of the Shares.
(v) Registration Rights
. No holder of securities of the Company has rights to the
registration of any securities of the Company because of the filing
of the Registration Statement, which rights have not been waived by
the holder thereof as of the date hereof.
(w) Listing . The
Common Stock is registered under Section 12(b) of the Exchange
Act and the Shares have been approved for listing on the NASDAQ
Capital Market, subject to notice of issuance.
(x) Possession of Intellectual
Property . Except as disclosed in the General Disclosure
Package, (i) each of the Company and the Subsidiary owns or
has adequate rights (or believes it can obtain adequate rights on
reasonable terms) to use all trademarks, trademark applications,
trade names, domain names, patents, patent applications, patent
rights, copyrights, technology, know-how, trade secrets, service
marks, trade dress rights, and other intellectual property and
proprietary rights (collectively, “ Intellectual
Property ”) and has such other licenses, approvals,
permits, and governmental authorizations with respect to such
Intellectual Property, in each case sufficient to conduct its
business as now conducted and as now proposed to be conducted,
except for the absence of rights to Intellectual Property that
would not reasonably be expected to have a Material Adverse Effect,
and, to the Company’s knowledge, none of the Intellectual
Property of the Company or the Subsidiary is invalid or
unenforceable, except where such invalidity or unenforceability
would not, individually or in the aggregate, reasonably be expected
to have a Material Adverse Effect, and all material patent
applications of the Company and the Subsidiary have been properly
filed and, to the Company’s knowledge, prosecuted in
accordance with all applicable laws, (ii) the Company has no
knowledge that the conduct of its business or the business of the
Subsidiary, as now conducted, and as now proposed to be conducted,
will infringe, misappropriate, conflict, or otherwise interfere
with, the Intellectual Property of any third party which,
individually or in the aggregate, would reasonably be expected to
have a Material Adverse Effect, (iii) the Company is not aware
of any infringement, misappropriation, conflict or violation by
Intellectual Property owned or controlled by any third party, of or
with the Company or the Subsidiary’s Intellectual Property,
which, individually or in the aggregate, would reasonably be
expected to have a Material Adverse Effect, (iv) there is no
pending or, to the Company’s knowledge, threatened action,
suit, proceeding, or other claim against the Company or the
Subsidiary or, to the Company’s knowledge, any employee of
the Company or the Subsidiary, asserting that the Company or the
Subsidiary’s Intellectual Property
8
infringes third party Intellectual
Property, which, individually or in the aggregate, would reasonably
be expected to have a Material Adverse Effect, and (v) neither
the Company nor the Subsidiary has received any written notice of
infringement with respect to any patent or any written notice
challenging the validity, scope or enforceability of any
Intellectual Property owned by or licensed to the Company or the
Subsidiary, which, individually or in the aggregate, would
reasonably be expected to have a Material Adverse Effect. Except as
disclosed in the General Disclosure Package, the Company and the
Subsidiary’s Intellectual Property is free and clear of any
pledge, lien, security interest, encumbrance, claim or equitable
interest whether imposed by agreement, contract, understanding, law
or equity, which, individually or in the aggregate, would
reasonably be expected to result in a Material Adverse
Effect.
(y) Taxes . Except as
disclosed in the General Disclosure Package, each of the Company
and the Subsidiary has filed all federal, state, local and foreign
income tax returns that have been required to be filed and has paid
all taxes and assessments received by it to the extent that such
taxes or assessments have become due, except where the taxes are
being contested by the Company or a Subsidiary are contesting such
matters in good faith and have established appropriate reserves
therefore in accordance with generally accepted accounting
principles or where the failure to do so would not, individually or
in the aggregate, reasonably be expected to have a Material Adverse
Effect. Neither the Company nor the Subsidiary has any tax
deficiency that has been or, to the knowledge of the Company, might
be asserted or threatened against it that would reasonably be
expected to have a Material Adverse Effect.
(z) Permits and Licenses
. Except as disclosed in the General Disclosure Package, each
of the Company and the Subsidiary owns or possesses all
authorizations, approvals, orders, licenses, registrations, other
certificates and permits of and from all governmental regulatory
officials and bodies, necessary to conduct its businesses as
contemplated in the General Disclosure Package, except where the
failure to own or possess all such authorizations, approvals,
orders, licenses, registrations, other certificates and permits
would not reasonably be expected to have a Material Adverse Effect.
There is no proceeding pending or threatened (or any basis therefor
known to the Company) that may cause any such authorization,
approval, order, license, registration, certificate or permit to be
revoked, withdrawn, cancelled, suspended or not renewed; and the
Company and the Subsidiary is conducting its business in compliance
with all laws, rules and regulations applicable thereto, except
where such noncompliance would not reasonably be expected to have a
Material Adverse Effect.
(aa) FCPA Compliance .
Neither the Company nor the Subsidiary has nor have, to the
Company’s knowledge, any of its or the Subsidiary’s
employees or agents 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 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.
(bb) Internal Controls and
Compliance With Sarbanes-Oxley Act . The Company is in
compliance in all material respects with the provisions of the
Sarbanes-Oxley Act of 2002 (“ Sarbanes-Oxley ”)
which are applicable to it. The Company maintains a system of
internal control over financial reporting (as defined in Rules
13a-15(f) and 15d-15(f) under the Exchange Act) sufficient to
provide reasonable assurances (1) that records are maintained
that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company;
(2) that transactions are recorded as necessary to permit
preparation of financial statements in accordance with U.S.
generally accepted accounting principles, and that receipts and
expenditures
9
of the Company are being made only
in accordance with authorizations of management and directors of
the Company; and (3) regarding prevention or timely detection
of unauthorized acquisition, use, or disposition of the
Company’s assets that could have a material effect on the
financial statements. The Company has established and maintains
disclosure controls and procedures (as defined in Rule 13a-15(e)
and 15d-15(e) under the Exchange Act). Such disclosure controls and
procedures are reasonably designed to ensure that information
required to be disclosed by the Company in the reports that it
files or submits under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in the
Commission’s rules and forms and that such information is
accumulated and communicated to the Company’s principal
executive officer and its principal financial officer. Such
disclosure controls and procedures are sufficient to provide
reasonable assurance that the Company’s principal executive
officer and principal financial officer are alerted to material
information required to be included in the Company’s periodic
reports required under the Exchange Act so as to allow timely
decisions regarding required disclosure. For purposes of the
preceding sentence, “principal executive officer” and
“principal financial officer” shall have the meanings
given to such terms in Sarbanes-Oxley.
(cc) ERISA Compliance
. Except as disclosed in the General Disclosure Package,
each of the Company and the Subsidiary has fulfilled in all
material respects its obligations, if any, under the minimum
funding standards of Section 302 of the United States Employee
Retirement Income Security Act of 1974 (“ ERISA
”) and the regulations and published interpretations
thereunder with respect to each “plan” (as defined in
Section 3(3) of ERISA and such regulations and published
interpretations) in which employees of the Company or the
Subsidiary are eligible to participate and each such plan is in
compliance in all material respects with the presently applicable
provisions of ERISA and such regulations and published
interpretations. No “prohibited transaction” (as
defined in Section 406 of ERISA, or Section 4975 of the
Internal Revenue Code of 1986, as amended from time to time) has
occurred with respect to any employee benefit plan which would
reasonably be expected to result in a Material Adverse
Effect.
(dd) Labor Issues . No
labor problem or dispute with the employees of the Company or the
Subsidiary exists or, to the Company’s knowledge, is
threatened or imminent, which would reasonably be expected to
result in a Material Adverse Effect. Except as disclosed in the
General Disclosure Package, the Company is not aware that any key
employee or significant group of employees of the Company or the
Subsidiary plans to terminate employment with the Company or the
Subsidiary.
(ee) Statistical and
Market-Related Data . Any third-party statistical and
market-related data included or incorporated by reference in the
Registration Statement and the General Disclosure Package are based
on or derived from sources that the Company believes to be reliable
and accurate.
(ff) Forward-Looking
Statements . No forward-looking statement (within the
meaning of Section 27A of the Act and Section 21E of the
Exchange Act) contained in the Registration Statement and the
General Disclosure Package has been made or reaffirmed without a
reasonable basis or has been disclosed other than in good
faith.
(gg) Environmental Laws
. Except as disclosed in the General Disclosure Package, each
of the Company and the Subsidiary (i) is in compliance with
any and all applicable federal, state, local and foreign laws,
rules, regulations, decisions and orders relating to the protection
of human health and safety, the environment or hazardous or toxic
substances or wastes, pollutants
10
or contaminants (collectively,
“ 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) has not received notice of any actual or
potential liability for the investigation or remediation of any
disposal or release of hazardous or toxic substances or wastes,
pollutants or contaminants, except in the case of subsections (i),
(ii) and (iii) of this subsection (gg) as would not,
individually or in the aggregate, reasonably be expected to have a
Material Adverse Effect.
(hh) Regulatory
Authorizations . Except as disclosed in the General
Disclosure Package, each of the Company and the Subsidiary
possesses all certificates, authorizations and permits issued by
the appropriate federal, state or foreign regulatory authorities
necessary to conduct its business (including without limitation,
applications for marketing approval, manufacture, distribution,
promotion, testing, use, or sale of any product candidates) as
disclosed in the General Disclosure Package, except where the
failure to possess such certificates, authorizations and permits
would not, individually or in the aggregate, reasonably be expected
to have a Material Adverse Effect; and the Company has not received
and is otherwise not aware of any notices, correspondence or other
communications from any regulatory agency or subdivision thereof,
relating to the revocation or modification of, non-compliance with,
or failure to obtain, any such certifica
