Exhibit 1.1
11,692,000 Shares
HANSEN MEDICAL,
INC.
Common Stock
PURCHASE AGREEMENT
April 17, 2009
PIPER JAFFRAY &
CO.
800 Nicollet Mall
Minneapolis, Minnesota 55402
Ladies and Gentlemen:
Hansen Medical, Inc., a Delaware
corporation (the “Company” ), proposes to
sell to Piper Jaffray & Co. (the
“Underwriter” ), an aggregate of
11,692,000 shares (the “Shares” ) of
Common Stock, $0.0001 par value per share (the “Common
Stock” ), of the Company.
The Company hereby confirms its
agreement with respect to the sale of the Shares to the
Underwriter.
1. Registration Statement and
Prospectus . The Company has prepared and filed with the
Securities and Exchange Commission (the
“Commission” ) a registration statement
on Form S-3 (File No. 333-149561) under the Securities Act of
1933, as amended (the “Securities Act” or
“Act” ) and the rules and regulations
(the “Rules and Regulations” ) of the
Commission thereunder, and such amendments to such registration
statement as may have been required to the date of this Agreement.
Such registration statement has been declared effective by the
Commission. Such registration statement, at any given time,
including amendments thereto to such time, the exhibits and any
schedules thereto at such time, the documents incorporated by
reference therein pursuant to Item 12 of Form S-3 under the
Securities Act at such time and the documents and information
otherwise deemed to be a part thereof or included therein by Rule
430B under the Securities Act (the “Rule 430B
Information” ) or otherwise pursuant to the Rules and
Regulations at such time, is herein called the
“Registration Statement.” The
Registration Statement at the time it originally became effective
is herein called the “Original Registration
Statement.” Any registration statement filed by the
Company pursuant to Rule 462(b) under the Securities Act is called
the “Rule 462(b) Registration Statement” and, from and
after the date and time of filing of the Rule 462(b) Registration
Statement, the term “Registration Statement” shall
include the Rule 462(b) Registration Statement.
The prospectus in the form in which
it appeared in the Original Registration Statement is herein called
the “Base Prospectus.” Promptly after
execution and delivery of this Agreement, the Company will prepare
and file with the Commission a final prospectus supplement to the
Base Prospectus relating to the Shares and the offering thereof in
accordance with the provisions Rule 430B and Rule 424(b) of the
Rules and Regulations. Such final supplemental form of
prospectus
(including the Base Prospectus as so
supplemented), in the form filed with the Commission pursuant to
Rule 424(b) is herein called the
“Prospectus.” Any reference herein to the
Base Prospectus or the Prospectus shall be deemed to refer to
include the documents incorporated by reference therein pursuant to
Item 12 of Form S-3 under the Securities Act as of the date of
such prospectus.
For purposes of this Agreement, all
references to the Registration Statement, the Rule 462(b)
Registration Statement, the Base Prospectus, the Prospectus 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 financial statements and schedules and other
information which is “described,”
“contained,” “included” or
“stated” in the Registration Statement, the Base
Prospectus, or the Prospectus (or other references of like import)
shall be deemed to mean and include all such financial statements
and schedules and other information which is incorporated by
reference in or otherwise deemed by the Rules and Regulations to be
a part of or included in the Registration Statement, the Base
Prospectus or the Prospectus, as the case may be; and all
references in this Agreement to amendments or supplements to the
Registration Statement, the Base Prospectus or the Prospectus shall
be deemed to mean and include the subsequent filing of any document
under the Securities Exchange Act of 1934, as amended (the
“Exchange Act” ) and which is deemed to
be incorporated therein by reference therein or otherwise deemed by
the Rules and Regulations to be a part thereof.
2. Representations and
Warranties of the Company .
(a) The Company represents and
warrants to, and agrees with, the Underwriter as
follows:
(i) The Statutory Prospectus (as
defined below) at the Time of Sale (as defined below) complied in
all material respects with the requirements of the Securities Act
and the Rules and Regulations and did 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, in the light of the circumstances under which they were
made, not misleading.
(ii) The Original Registration
Statement was initially declared effective by the Commission under
the Securities Act on March 17, 2008. The Company has
complied, to the Commission’s satisfaction, with all requests
of the Commission for additional or supplemental information. No
stop order suspending the effectiveness of the Registration
Statement is in effect and no proceedings for such purpose have
been instituted or are pending or, to the best knowledge of the
Company, are contemplated or threatened by the
Commission.
(iii) Each part of the Registration
Statement, any Rule 462(b) Registration Statement and any
post-effective amendment thereto, at the time such part became
effective (including each deemed effective date with respect to the
Underwriter pursuant to Rule 430B or otherwise under the Securities
Act), at all other subsequent times
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until the expiration of the
Prospectus Delivery Period (as defined below), and at the Closing
Date (as hereinafter defined), and the Prospectus, at the time of
filing or the time of first use within the meaning of the Rules and
Regulations, at all subsequent times until expiration of the
Prospectus Delivery Period, and at the Closing Date complied and
will comply in all material respects with the applicable
requirements and provisions of the Securities Act, the Rules and
Regulations and the Exchange Act and did not and will not contain
any untrue statement of a material fact or omit to state a material
fact required to be stated therein or necessary to make the
statements therein not misleading. The Prospectus, as of its date,
or the time of first use within the meaning of the Rules and
Regulations, at all subsequent times until the expiration of the
Prospectus Delivery Period, and at the Closing Date, did not and
will not contain any untrue statement of a material fact or omit to
state a material fact necessary in order to make the statements
therein, in the light of the circumstances under which they were
made, not misleading. The representations and warranties set forth
in the two immediately preceding sentences do not apply to
statements in or omissions from the Registration Statement, any
Rule 462(b) Registration Statement, or any post-effective amendment
thereto, or the Prospectus, made in reliance upon and in conformity
with written information furnished in writing to the Company by the
Underwriter.
(iv) Neither (A) any Issuer
General Free Writing Prospectus(es) issued at or prior to the Time
of Sale and set forth on Schedule I, the information set forth on
Schedule II and the Statutory Prospectus at the Time of Sale, all
considered together (collectively, the “ Time of Sale
Disclosure Package ”), nor (B) any individual
Issuer Limited-Use Free Writing Prospectus, when considered
together with the Time of Sale Disclosure Package, includes or
included as of the Time of Sale any untrue statement of a material
fact or omit or omitted as of the Time of Sale to state any
material fact necessary in order to make the statements therein, in
the light of the circumstances under which they were made, not
misleading. The preceding sentence does not apply to statements in
or omissions from any Statutory Prospectus or any Issuer Free
Writing Prospectus based upon and in conformity with written
information furnished to the Company by the Underwriter
specifically for use in the preparation thereof. As used in this
paragraph and elsewhere in this Agreement:
(1) “Time of
Sale” means 9:00 AM (New York City time) on the date
of this Agreement.
(2) “Statutory
Prospectus” means the Base Prospectus, 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. For purposes of this
definition, information contained in a form of prospectus that is
deemed retroactively to be a part of the Registration Statement
pursuant to Rule 430B under the Securities Act shall be considered
to be included in the Statutory Prospectus as of the actual time
that form of prospectus is filed with the Commission pursuant to
Rule 424(b) under the Securities Act.
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(3) “Issuer Free Writing
Prospectus” means any “issuer free writing
prospectus,” as defined in Rule 433 under the Securities Act,
relating to the Shares that (A) is required to be filed with
the Commission by the Company, or (B) is exempt from filing
pursuant to Rule 433(d)(5)(i) under the Securities Act because it
contains a description of the Shares or of the offering that does
not reflect the final terms, or is a “bona fide electronic
roadshow,” as defined in Rule 433 of the Rules and
Regulations, in each case 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 Securities Act.
(4) “Issuer General Free
Writing Prospectus” means any Issuer Free Writing
Prospectus that is intended for general distribution to prospective
investors, as evidenced by its being specified in Schedule I
hereto.
(5) “ Issuer Limited-Use
Free Writing Prospectus” means any Issuer Free
Writing Prospectus that is not an Issuer General Free Writing
Prospectus.
(v) Each Issuer Free Writing
Prospectus, as of its issue date and at all subsequent times
through the Prospectus Delivery Period or until any earlier date
that the Company notified or notifies the Underwriter as described
in Section 4(iii)(B), did not, does not and will not include
any information that conflicted, conflicts or will conflict with
the information contained in the Registration Statement, any
Statutory Prospectus or the Prospectus. The foregoing sentence does
not apply to statements in or omissions from any Issuer Free
Writing Prospectus based upon and in conformity with written
information furnished in writing to the Company by the Underwriter
expressly for use therein.
(B) (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
Shares and (2) at the date hereof, the Company was not and is
not an “ineligible issuer,” as defined in Rule 405
under the Securities Act, in the preceding three years not having
been convicted of a felony or misdemeanor or having been made the
subject of a judicial or administrative decree or order as
described in Rule 405 (without taking account of any determination
by the Commission pursuant to Rule 405 that it is not necessary
that the Company be considered an ineligible issuer), nor an
“excluded issuer” as defined in Rule 164 under the
Securities Act.
(C) Each Issuer Free Writing
Prospectus satisfied, as of its issue date and at all subsequent
times through the Prospectus Delivery Period, all other conditions
to use thereof as set forth in Rules 164 and 433 under the
Securities Act.
(vi) The consolidated financial
statements of the Company and its subsidiaries, together with the
related notes, set forth or incorporated by reference, in the
Registration Statement, the Time of Sale Disclosure Package and the
Prospectus comply
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in all material respects with the
requirements of the Securities Act and the Exchange Act and fairly
present the financial condition of the Company and its consolidated
subsidiaries as of the dates indicated and the results of
operations and changes in cash flows for the periods therein
specified in conformity with generally accepted accounting
principles in the United States consistently applied throughout the
periods involved; and the supporting schedules included in the
Registration Statement, the Time of Sale Disclosure Package and the
Prospectus have been derived from the accounting records of the
Company and present fairly the information required to be stated
therein. No schedules or other financial statements are required to
be included in the Registration Statement, the Time of Sale
Disclosure Package or the Prospectus. To the Company’s
knowledge, PricewaterhouseCoopers LLP, which has expressed its
opinion with respect to the financial statements filed as a part of
the Registration Statement and included in the Registration
Statement, the Time of Sale Disclosure Package and the Prospectus,
is (x) an independent public accounting firm within the
meaning of the Securities Act and the Rules and Regulations,
(y) a registered public accounting firm (as defined in
Section 2(a)(12) of the Sarbanes-Oxley Act of 2002 (the
“Sarbanes-Oxley Act” )) and (z) in
the performance of their work for the Company, not in violation of
the auditor independence requirements of the Sarbanes-Oxley Act.
Except as described in the Time of Sale Disclosure Package and the
Prospectus, there are no material off-balance sheet transactions,
arrangements, obligations (including contingent obligations), or
any other relationships with unconsolidated entities or other
persons, that may have a material current or, to the
Company’s knowledge, future effect on the Company’s
financial condition, changes in financial condition, results of
operations, liquidity, capital expenditures, capital resources or
significant components of revenue or expenses.
(vii) The Company has been duly
organized and is validly existing as a corporation in good standing
under the laws of the State of Delaware. The Company has full
corporate power and authority to own its properties and conduct its
business as currently being conducted and as described in the
Registration Statement, the Time of Sale Disclosure Package and the
Prospectus, and is duly qualified to do business as a foreign
corporation in good standing in each jurisdiction in which it owns
or leases real property or in which the conduct of its business
makes such qualification necessary and in which the failure to so
qualify might result in a material adverse change in the general
affairs, condition (financial or otherwise), business, prospects,
property, operations or results of operations of the Company and
its subsidiaries, taken as a whole ( “Material Adverse
Change” ). Each subsidiary of the Company has been
duly incorporated, is validly existing as a corporation in good
standing under the laws of the jurisdiction of its incorporation,
has the corporate power and authority to own its property and to
conduct its business as described in the Registration Statement,
Time of Sale Disclosure Package and the Prospectus and is duly
qualified to transact business and is in good standing in each
jurisdiction in which the conduct of its business or its ownership
or leasing of property requires such qualification, except to the
extent that the failure to be so qualified or be in good standing
would not result in a Material Adverse Change; all of the issued
shares of capital stock of each subsidiary of the Company have been
duly and validly authorized and issued, are fully paid and
non-assessable and are owned directly by the Company, free and
clear of all liens, encumbrances, equities or claims. Except as set
forth in the Time of Sale Disclosure Package, the Company is not a
participant in any joint venture, partnership or similar
arrangement.
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(viii) Except as contemplated in the
Time of Sale Disclosure Package and the Prospectus, subsequent to
the respective dates as of which information is given in the
Registration Statement, the Time of Sale Disclosure Package and the
Prospectus, (a) neither the Company nor any of its
subsidiaries has incurred any material liabilities or obligations,
direct or contingent, or entered into any material transactions, or
declared or paid any dividends or made any distribution of any kind
with respect to its capital stock; and (b) there has not been
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 any
material change in the short term or long term debt, or any
issuance of options, warrants, convertible securities or other
rights to purchase the capital stock, of the Company (other than
issuances of options under the Company’s existing stock
option plans), or any Material Adverse Change or any development
that could reasonably be expected to result in a Material Adverse
Change.
(ix) Except as set forth in the Time
of Sale Disclosure Package and the Prospectus, there is not pending
or, to the knowledge of the Company, threatened or contemplated,
any action, suit or proceeding to which the Company or any of its
subsidiaries is a party or of which any property or assets of the
Company or any of its subsidiaries is the subject before or by any
court or governmental agency, authority or body, or any arbitrator,
which, individually or in the aggregate, could reasonably be
expected to result in any Material Adverse Change. There are no
current or pending legal, governmental or regulatory actions, suits
or proceedings that are required to be described in the
Registration Statement, the Time of Sale Disclosure Package and the
Prospectus that have not been so described.
(x) There are no statutes,
regulations, contracts or documents that are required to be
described in the Registration Statement, the Time of Sale
Disclosure Package and the Prospectus or to be filed as exhibits to
the Registration Statement by the Act or by the Rules and
Regulations that have not been so described or filed.
(xi) This Agreement has been duly
authorized, executed and delivered by the Company, and constitutes
a valid, legal and binding obligation of the Company, enforceable
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 bankruptcy,
insolvency, reorganization or similar laws affecting the rights of
creditors generally and subject to general principles of equity.
The execution, delivery and performance of this Agreement and the
consummation of the transactions herein contemplated will not
(A) conflict with or result in a breach or violation of any of
the terms or provisions of, or constitute a default under, or
result in the creation or imposition of any lien, charge or
encumbrance upon any property or assets of the Company or any of
its subsidiaries pursuant to, any indenture, mortgage, deed of
trust, loan agreement or other agreement or instrument to which the
Company or any of its subsidiaries are a party or by which the
Company or any of its subsidiaries are bound or to which any of the
property or assets of the Company or any of its subsidiaries is
subject except for any such conflict,
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breach, violation, default or
imposition of a lien, charge or encumbrance that would not
reasonably be expected to result in a Material Adverse Change,
(B) result in any violation of the provisions of the charter
or by-laws of the Company or any of its subsidiaries or
(C) result in the violation of any law or statute or any
judgment, order, rule or regulation of any court or arbitrator or
governmental or regulatory authority. No consent, approval,
authorization or order of, or filing with, any court or
governmental agency or body is required for the execution, delivery
and performance of this Agreement or for the consummation of the
transactions contemplated hereby, including the issuance or sale of
the Shares by the Company, except such as may be required under the
Act or state securities or blue sky laws; and the Company has full
power and authority to enter into this Agreement and to consummate
the transactions contemplated hereby including the authorization,
issuance and sale of the Shares as contemplated by this
Agreement.
(xii) All of the issued and
outstanding shares of capital stock of the Company, including the
outstanding shares of Common Stock, are duly authorized and validly
issued, fully paid and nonassessable, have been issued in
compliance with all federal and state securities laws, were not
issued in violation of or subject to any preemptive rights or other
rights to subscribe for or purchase securities that have not been
waived in writing (a copy of which has been delivered to counsel to
the Underwriter); the Shares which may be sold hereunder by the
Company have been duly authorized and, when issued, delivered and
paid for in accordance with the terms of this Agreement, will have
been validly issued and will be fully paid and nonassessable, and
the holders thereof will not be subject to personal liability
solely by reason of being such holders; and the capital stock of
the Company, including the Common Stock, conforms to the
description thereof in the Registration Statement, the Time of Sale
Disclosure Package and the Prospectus. Except as otherwise
described in the Registration Statement, the Time of Sale
Disclosure Package and the Prospectus, there are no preemptive
rights or other rights to subscribe for or to purchase, or any
restriction upon the voting or transfer of, any shares of Common
Stock pursuant to the Company’s charter, by laws or any
agreement or other instrument to which the Company is a party or by
which the Company is bound. Neither the filing of the Registration
Statement nor the offering or sale of the Shares as contemplated by
this Agreement gives rise to any rights for or relating to the
registration of any shares of Common Stock or other Shares of the
Company that have not been fully complied with or previously
waived. Except as described or contemplated in the Registration
Statement, the Time of Sale Disclosure Package and the Prospectus,
there are no options, warrants, agreements, contracts or other
rights in existence to purchase or acquire from the Company any
shares of the capital stock of the Company. The Company has an
authorized and outstanding capitalization as set forth in the
Registration Statement, the Time of Sale Disclosure Package and the
Prospectus. The description of the Company’s stock option,
stock bonus and other stock plans or arrangements, and the options
or other rights granted thereunder, set forth in the Time of Sale
Disclosure Package and the Prospectus accurately and fairly
presents the information required to be shown with respect to such
plans, arrangements, options and rights.
(xiii) The Company and each of its
subsidiaries holds, and is operating in compliance in all material
respects with, all franchises, grants, authorizations,
licenses,
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permits, easements, consents,
certificates and orders of any Governmental Authority or
self-regulatory body required for the conduct of its business and
all such franchises, grants, authorizations, licenses, permits,
easements, consents, certifications and orders are valid and in
full force and effect; and neither the Company nor any of its
subsidiaries has received notice of any revocation or modification
of any such franchise, grant, authorization, license, permit,
easement, consent, certification or order or has reason to believe
that any such franchise, grant, authorization, license, permit,
easement, consent, certification or order will not be renewed in
the ordinary course; and the Company and each of its subsidiaries
is in compliance in all material respects with all applicable
federal, state, local and foreign laws, regulations, orders and
decrees.
(xiv) The Company and its
subsidiaries have good and marketable title to all property
(whether real or personal) described in the Registration Statement,
the Time of Sale Disclosure Package and the Prospectus as being
owned by them, in each case free and clear of all liens, claims,
security interests, other encumbrances or defects except as
described in the Registration Statement, the Time of Sale
Disclosure Package and the Prospectus, and except those that could
not, individually or in the aggregate, reasonably be expected to
result in a Material Adverse Change. The property held under lease
by the Company and its subsidiaries is held by them under valid,
subsisting and enforceable leases with only such exceptions with
respect to any particular lease as do not interfere in any material
respect with the conduct of the business of the Company or and its
subsidiaries.
(xv) The Company and its
subsidiaries own, possess, or can acquire on reasonable terms, all
Intellectual Property necessary for the conduct of the their
business as now conducted or as described in the Registration
Statement, the Time of Sale Disclosure Package and the Prospectus
to be conducted, except as such failure to own, possess, or acquire
such rights would not result in a Material Adverse Change. Except
as set forth in the Registration Statement, the Time of Sale
Disclosure Package and the Prospectus, (A) to the knowledge of
the Company, there is no infringement, misappropriation or
violation by third parties of any such Intellectual Property,
except as such infringement, misappropriation or violation would
not result in a Material Adverse Change; (B) there is no
pending or, to the knowledge of the Company, threatened action,
suit, proceeding or claim by others challenging the Company’s
or its subsidiaries’ rights in or to any such Intellectual
Property, and the Company is unaware of any facts which would form
a reasonable basis for any such claim; (C) the Intellectual
Property owned by the Company and its subsidiaries and to the
knowledge of the Company, the Intellectual Property licensed to the
Company and its subsidiaries have not been adjudged invalid or
unenforceable, in whole or in part, and there is no pending or
threatened action, suit, proceeding or claim by others challenging
the validity or scope of any such Intellectual Property, and the
Company is unaware of any facts which would form a reasonable basis
for any such claim; (D) there is no pending or threatened
action, suit, proceeding or claim by others that the Company or any
of its subsidiaries infringe, misappropriate or otherwise violate
any Intellectual Property or other proprietary rights of others,
neither the Company nor any of its subsidiaries has received any
written notice of such claim and the Company is unaware of any
other fact which would form a reasonable basis for any such claim;
and (E) to the Company’s knowledge, no employee of the
Company or any of its subsidiaries is in or has ever been in
violation of any
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term of any employment contract,
patent disclosure agreement, invention assignment agreement,
non-competition agreement, non-solicitation agreement,
nondisclosure agreement or any restrictive covenant to or with a
former employer where the basis of such violation relates to such
employee’s employment with the Company or any of its
subsidiaries or actions undertaken by the employee while employed
with the Company or any of its subsidiaries. “
Intellectual Property ” shall mean all patents,
patent applications, trade and service marks, trade and service
mark registrations, trade names, copyrights, licenses, inventions,
trade secrets, technology, know-how and other intellectual
property.
(xvi) Neither the Company nor any of
its subsidiaries are (A) in violation of their charter or by
laws; (B) in breach of or otherwise in default, and no event
has occurred which, with notice or lapse of time or both, would
constitute such a default in the performance or observance of any
term, covenant, obligation, agreement or condition contained in any
bond, debenture, note, indenture, loan agreement, mortgage, deed of
trust or any other contract, lease or other instrument to which it
is subject or by which it may be bound, or to which any of the
material property or assets of the Company or any of its
subsidiaries are subject; or (C) in violation of any law or
statute or any judgment, order, rule or regulation of any court or
arbitrator or governmental or regulatory authority, except in the
case of (B) and (C) above, as could not, individually or
in the aggregate, reasonably be expected to result in a Material
Adverse Change.
(xvii) The Company and its
subsidiaries have timely filed all federal, state, local and
foreign income and franchise tax returns required to be filed and
are not in default in the payment of any material taxes which were
payable pursuant to said returns or any assessments with respect
thereto, other than any which the Company or any of its
subsidiaries are contesting in good faith. There is no pending
dispute with any taxing authority relating to any of such returns
and the Company has no knowledge of any proposed liability for any
tax to be imposed upon the properties or assets of the Company or
any of its subsidiaries for which there is not an adequate reserve
reflected in the Company’s financial statements included in
the Registration Statement.
(xviii) Other than the subsidiaries
of the Company listed in Exhibit 21 to the Company’s
Annual Report on Form 10-K for the fiscal year ended
December 31, 2008 and the Company’s ownership of less
than 10% of the outstanding capital stock of Advanced Cardiac
Therapeutics, Inc., the Company, directly or indirectly, owns no
capital stock or other equity or ownership or proprietary interest
in any corporation, partnership, association, trust or other
entity.
(xix) The Company has not
distributed and will not distribute any prospectus or other
offering material in connection with the offering and sale of the
Shares other than the Time of Sale Disclosure Package or the
Prospectus or other materials permitted by the Securities Act to be
distributed by the Company; provided, however, that, except
as set forth on Schedule I, the Company has not made and will not
make any offer relating to the Shares that would constitute a
“free writing prospectus” as defined in Rule 405 under
the Securities Act, except in accordance with the provisions of
Section 4(xvi) of this Agreement.
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(xx) The Common Stock of the Company
is registered and listed on The NASDAQ Global Market (
“NASDAQ” ) under the ticker symbol
“HNSN.” The Company has not received any notice that it
is not in compliance with the listing or maintenance requirements
of NASDAQ. The Company believes that it is, and has no reason to
believe that it will not in the foreseeable future continue to be,
in material compliance with all such listing and maintenance
requirements. Except as described in the Registration Statement,
the Time of Sale Disclosure Package or the Prospectus, there are no
affiliations among the Company’s directors and officers and
members of the Financial Institution Regulatory Authority (
“FINRA” ). A Registration Statement
relating to the Common Stock on Form 8-A or other applicable form
under the Exchange Act has become effective.
(xxi) The Company maintains a system
of internal accounting controls sufficient to provide reasonable
assurances that (A) transactions are executed in accordance
with management’s general or specific authorization;
(B) transactions are recorded as necessary to permit
preparation of financial statements in conformity with generally
accepted accounting principles in the United States and to maintain
accountability for assets; (C) access to assets is permitted
only in accordance with management’s general or specific
authorization; and (D) the recorded accountability for assets
is compared with existing assets at reasonable intervals and
appropriate action is taken with respect to any differences. Except
as disclosed in the Registration Statement, in the Time of Sale
Disclosure Package and in the Prospectus, the Company’s
internal control over financial reporting is effective and none of
the Company, its board of directors and audit committee is aware of
any “significant deficiencies” or “material
weaknesses” (each as defined by the Public Company Accounting
Oversight Board) in its internal control over financial reporting,
or any fraud, whether or not material, that involves management or
other employees of the Company who have a significant role in the
Company’s internal controls; and since the end of the latest
audited fiscal year, there has been no change in the
Company’s internal control over financial reporting (whether
or not remediated) that has materially affected, or is reasonably
likely to materially affect, the Company’s internal control
over financial reporting. The Company’s board of directors
has, subject to the exceptions, cure periods and the phase in
periods specified in the applicable stock exchange rules (“
Exchange Rules ”), validly appointed an audit
committee to oversee internal accounting controls whose composition
satisfies the applicable requirements of the Exchange Rules and the
Company’s board of directors and/or the audit committee has
adopted a charter that satisfies the requirements of the Exchange
Rules.
(xxii) The Company’s board of
directors has validly appointed an audit committee whose
composition satisfies the applicable requirements of Rule
4350(d)(2) of the Rules of the National Association of Securities
Dealers (the “ NASD Rules ”) and the
Company’s board of directors and/or the audit committee has
adopted a charter that satisfies the requirements of Rule
4350(d)(1) of the NASD Rules. Neither the Company’s board of
directors nor the audit committee has been informed, nor is any
director of the Company aware, of (A) any significant
deficiencies in the design or operation of the Company’s
internal controls which could adversely affect the Company’s
ability to record, process, summarize and report financial data or
any material weakness in the Company’s internal controls; or
(B) any fraud, whether or not material, that involves
management or other employees of the Company who have a significant
role in the Company’s internal controls.
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(xxiii) No relationship, direct or
indirect, exists between or among the Company, on the one hand, and
the directors, officers, stockholders, customers or suppliers of
the Company, on the other hand, which is required to be described
in the Registration Statement, the Time of Sale Disclosure Package
and the Prospectus which is not so described. The Company has not,
directly or indirectly, extended or maintained credit, or arranged
for the extension of credit, or renewed an extension of credit, in
the form of a personal loan to or for any of its directors or
executive officers in violation of applicable laws, including
Section 402 of the Sarbanes-Oxley Act.
(xxiv) Except as described in the
Registration Statement, the Time of Sale Disclosure Package and the
Prospectus, the Company and its subsidiaries: (A) are and at
all times have been in full compliance with all statutes, rules,
regulations, or guidances applicable to Company and its
subsidiaries and the ownership, testing, development, manufacture,
packaging, processing, use, distribution, marketing, labeling,
promotion, sale, offer for sale, storage, import, export or
disposal of any product manufactured or distributed by the Company
( “Applicable Laws” ), except as could
not, individually or in the aggregate, reasonably be expected to
result in a Material Adverse Change; (B) have not received any
FDA Form 483, notice of adverse finding, warning letter, untitled
letter or other correspondence or notice from the U.S. Food and
Drug Administration or any other federal, state or foreign
governmental authority having authority over the Company (
“Governmental Authority” ) alleging or
asserting noncompliance with any Applicable Laws or any licenses,
certificates, approvals, clearances, authorizations, permits and
supplements or amendments thereto required by any such Applicable
Laws ( “Authorizations” );
(C) possess all material Authorizations and such
Authorizations are valid and in full force and effect and are not
in violation of any term of any such Authorizations; (D) have
not received notice of any claim, action, suit, proceeding,
hearing, enforcement, investigation, arbitration or other action
from any Governmental Authority or third party alleging that any
product operation or activity is in violation of any Applicable
Laws or Authorizations and have no knowledge that any such
Governmental Authority or third party is considering any such
claim, litigation, arbitration, action, suit, investigation or
proceeding; (E) have not received notice that any Governmental
Authority has taken, is taking or intends to take action to limit,
suspend, modify or revoke any Authorizations and the Company has no
knowledge that any such Governmental Authority is considering such
action; and (F) have filed, obtained, maintained or submitted
all material reports, documents, forms, notices, applications,
records, claims, submissions and supplements or amendments as
required by any Applicable Laws or Authorizations and that all such
reports, documents, forms, notices, applications, records, claims,
submissions and supplements or amendments were complete and correct
in all material respects on the date filed (or were corrected or
supplemented by a subsequent submission).
(xxv) The studies, tests and
preclinical and clinical trials conducted by or on behalf of the
Company and its subsidiaries were and, if still pending, are, in
all material respects, being conducted in accordance with
experimental protocols, procedures
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and controls pursuant to accepted
professional scientific standards and all Applicable Laws and
Authorizations, including, without limitation, the Federal Food,
Drug and Cosmetic Act and implementing regulations at 21 C.F.R.
Parts 50, 54, 56, 58 and 812; the descriptions of the results of
such studies, tests and trials contained in the Registration
Statement, the Time of Sale Disclosure Package and the Prospectus
are accurate and complete in all material respects and fairly
present the data derived from such studies, tests and trials;
except to the extent disclosed in the Registration Statement, the
Time of Sale Disclosure Package and the Prospectus, the Company is
not aware of any studies, tests or trials the results of which the
Company believes reasonably call into question the study, test, or
trial results described or referred to in the Registration
Statement, the Time of Sale Disclosure Package and the Prospectus
when viewed in the context in which such results are described and
the clinical state of development; and neither the Company nor any
of its subsidiaries have received any notices or correspondence
from any Governmental Authority requiring the termination,
suspension or material modification of any studies, tests or
preclinical or clinical trials conducted by or on behalf of the
Company or any of its subsidiaries.
(xxvi) The Company and its
subsidiaries (A) are 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 or contaminants (collectively, “
Environmental Laws ”); (B) have received
and are in material compliance with all permits, licenses or other
approvals required of them under applicable Environmental Laws to
conduct their business; and (C) have 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 any
such case for any such failure to comply, or failure to receive
required permits, licenses or approvals, or liability as would not,
individually or in the aggregate, result in a Material Adverse
Change.
(xxvii) The documents incorporated
by reference in the Time of Sale Disclosure Package and in the
Prospectus, when they became effective or were filed with the
Commission, as the case may be, conformed in all material respects
to the requirements of the Securities Act or the Exchange Act, as
applicable, and were filed on a timely basis with the Commission
and none of such documents contained an untrue statement of a
material fact or omitted to state a material fact necessary to make
the statements therein, in the light of the circumstances under
which they were made, not misleading; any further documents so
filed and incorporated by reference in the Time of Sale Disclosure
Package or in the Prospectus, when such documents are filed with
the Commission, will conform in all material respects to the
requirements of the Exchange Act, and will not contain an untrue
statement of a material fact or omit to state a material fact
necessary to make the statements therein, in the light of the
circumstances under which they were made, not
misleading.
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