Exhibit 1.1
3,000,000
Shares
HANSEN MEDICAL, INC.
COMMON STOCK, PAR VALUE
$0.0001 PER SHARE
UNDERWRITING
AGREEMENT
April 1, 2008
April 1, 2008
Morgan
Stanley & Co. Incorporated
1585 Broadway
New York, New York 10036
Ladies
and Gentlemen:
Hansen Medical, Inc., a Delaware
corporation (the “ Company ”), proposes to issue
and sell to Morgan Stanley & Co. Incorporated (the “
Underwriter ”) 3,000,000 shares of its Common Stock,
par value $0.0001 per share (the “ Shares ”).
The shares of Common Stock, par value $0.0001 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 has filed with the
Securities and Exchange Commission (the “ Commission
”) a registration statement, including a prospectus, (the
file number of which is set forth in Schedule I hereto) on Form
S-3, relating to the securities (the “ Shelf
Securities ”), including the Shares, to be issued from
time to time by the Company. The registration statement as amended
to the date of this Agreement, 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 Securities Act of 1933, as amended (the “ Securities
Act ”), is hereinafter referred to as the “
Registration Statement ”, and the related prospectus
covering the Shelf Securities dated March 17, 2008 in the form
first used to confirm sales of the Shares (or in the form first
made available to the Underwriter by the Company to meet requests
of purchasers pursuant to Rule 173 under the Securities Act)
is hereinafter referred to as the “ Basic Prospectus
.” The Basic Prospectus, as supplemented by the prospectus
supplement specifically relating to the Shares in the form first
used to confirm sales of the Shares (or in the form first made
available to the Underwriter by the Company to meet requests of
purchasers pursuant to Rule 173 under the Securities Act) is
hereinafter referred to as the “ Prospectus ,”
and the term “ preliminary prospectus ” means
any preliminary form of the Prospectus. If the Company has filed an
abbreviated registration statement to register additional shares of
Common Stock pursuant to Rule 462(b) under the Securities Act (the
“ Rule 462 Registration Statement ”), then
any reference herein to the term “Registration
Statement” shall be deemed to include such Rule 462
Registration Statement.
For purposes of this Agreement,
“ free writing prospectus ” has the meaning set
forth in Rule 405 under the Securities Act, “ issuer free
writing
prospectus ” has the meaning set forth in Rule 433 of
the Securities Act, relating to the Shares that (i) is
required to be filed with the Commission by the Company,
(ii) is a “road show that is a written
communication” within the meaning of Rule 433(d)(8)(i)
whether or not required to be filed with the Commission or
(iii) is exempt from filing pursuant to Rule 433(d)(5)(i)
because it contains a description of the Shares or of the offering
that does not reflect the final terms, 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), “ Time of Sale
Prospectus ” means the Basic Prospectus and the
preliminary prospectus together with the free writing prospectuses,
if any, each identified in Schedule II hereto, and "
broadly available road show ” means a “bona fide
electronic road show” as defined in Rule 433(h)(5) under
the Securities Act that has been made available without restriction
to any person. As used herein, the terms “Registration
Statement,” “Basic Prospectus,”
“preliminary prospectus,” “Time of Sale
Prospectus” 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
Time of Sale Prospectus, any preliminary prospectus or 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.
1. Representations and
Warranties . The Company represents and warrants to and agrees
with the Underwriter that:
(a) 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, to the knowledge of the Company
and its subsidiaries, threatened by the Commission.
(b) (i) Each document, if
any, filed or to be filed pursuant to the Exchange Act and
incorporated by reference in the Time of Sale Prospectus or the
Prospectus complied or will comply when so filed in all material
respects with the Exchange Act and the applicable rules and
regulations of the Commission thereunder; (ii) each part of
the Registration Statement, when such part became effective, did
not contain, and each such part, as amended or supplemented, if
applicable, 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,
(iii) the Registration Statement as of the date hereof does
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, (iv) the
Registration Statement and the Prospectus comply, and as
2
amended
or supplemented, if applicable, will comply in all material
respects with the Securities Act and the applicable rules and
regulations of the Commission thereunder, (v) the Time of Sale
Prospectus does not, and at the time of each sale of the Shares in
connection with the offering when the Prospectus is not yet
available to prospective purchasers and at the Closing Date (as
defined in Section 4), the Time of Sale Prospectus, as then
amended or supplemented by the Company, if applicable, will not,
contain any 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, (vi) each broadly available road show, if any,
when considered together with the Time of Sale Prospectus, does not
contain any 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 and (vii) the Prospectus does not contain and, as
amended or supplemented, if applicable, will not contain any 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, except
that the representations and warranties set forth in this paragraph
do not apply to statements or omissions in the Registration
Statement, the Time of Sale Prospectus or the Prospectus based upon
information relating to the Underwriter furnished to the Company in
writing by the Underwriter expressly for use therein.
(c) The Company is not an
“ineligible issuer” in connection with the offering
pursuant to Rules 164, 405 and 433 under the Securities Act.
Any free writing prospectus that the Company is required to file
pursuant to Rule 433(d) under the Securities Act has been, or will
be, filed with the Commission in accordance with the requirements
of the Securities 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 Securities Act or that was prepared by or behalf of or
used or referred to by the Company complies or will comply in all
material respects with the requirements of the Securities Act and
the applicable rules and regulations of the Commission thereunder.
Except for the free writing prospectuses, if any, identified in
Schedule II hereto forming part of the Time of Sale
Prospectus, and electronic road shows, if any, each furnished to
you before first use, the Company has not prepared, used or
referred to, and will not, without your prior consent, prepare, use
or refer to, any free writing prospectus.
(d) 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 Time of Sale Prospectus and is
duly qualified to transact business and is in good standing in each
jurisdiction in which
3
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 have a material
adverse effect on the Company and its subsidiaries, taken as a
whole.
(e) 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 Time of
Sale 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 have a material adverse
effect on the Company and its subsidiaries, taken as a whole; 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.
(f) This Agreement has been duly
authorized, executed and delivered by the Company.
(g) The authorized capital stock
of the Company conforms as to legal matters to the description
thereof contained in each of the Time of Sale Prospectus and the
Prospectus.
(h) The shares of Common Stock
outstanding prior to the issuance of the Shares have been duly
authorized and are validly issued, fully paid and
non-assessable.
(i) The Shares have been duly
authorized and, when issued and delivered in accordance with the
terms of this Agreement, will be validly issued, fully paid and
non-assessable, and the issuance of such Shares will not be subject
to any preemptive or similar rights.
(j) Except as disclosed in the
questionnaires delivered by the Company to the Underwriter or its
counsel, to the Company’s and its subsidiaries’
knowledge, none of the Company’s officers or directors are
affiliated with any member firm of the Financial Industry
Regulatory Authority, Inc. (the “ FINRA
”).
(k) The execution and delivery
by the Company of, and the performance by the Company of its
obligations under, this Agreement will not (i) 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,
4
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 is a party or by which the
Company or any of its subsidiaries is bound or to which any of the
property or assets of the Company or any of its subsidiaries is
subject, (ii) result in any violation of the provisions of the
certificate of incorporation or bylaws of the Company or
(iii) result in the violation of any law or statute or any
judgment, order, rule or regulation of any court or arbitrator or
federal, state, local or foreign governmental or regulatory
authority (each a, “ Governmental Authority ”),
except, in the case of clause (i), for any such contravention,
conflict, violation, breach, default or imposition of a lien,
charge or encumbrance that would not, individually or in the
aggregate, reasonably be expected to have a material adverse effect
on the Company and its subsidiaries, taken as a whole; and no
consent, approval, authorization or order of, or qualification
with, any governmental body or agency is required for the execution
and delivery of this Agreement by the Company and the performance
by the Company of its obligations under this Agreement, except such
as may be required under applicable state securities laws or the
bylaws, rules and regulations of the FINRA in connection with the
purchase and distribution of the Shares by the Underwriter.
(l) There has not occurred any
material adverse change, or any development involving a prospective
material adverse change, in the condition, financial or otherwise,
or in the earnings, business or operations of the Company and its
subsidiaries, taken as a whole, from that set forth in the Time of
Sale Prospectus.
(m) There are no legal or
governmental proceedings pending or, to the knowledge of the
Company and its subsidiaries, threatened to which the Company or
any of its subsidiaries is a party or to which any of the
properties of the Company or any of its subsidiaries is subject
(i) other than proceedings accurately described in the Time of
Sale Prospectus or proceedings that would not have a material
adverse effect on the Company and its subsidiaries, taken as a
whole, or on the power or ability of the Company to perform its
obligations under this Agreement or to consummate the transactions
contemplated by the Time of Sale Prospectus or (ii) that are
required to be described in the Registration Statement or the
Prospectus that are not so described in the Registration Statement,
the Time of Sale Prospectus and the Prospectus; and there are no
statutes, regulations, contracts or other documents that are
required to be described in the Registration Statement or the
Prospectus or to be filed as exhibits to the Registration Statement
that are not described in the Registration Statement, the Time of
Sale Prospectus and the Prospectus or filed as required.
5
(n) No order preventing or
suspending the use of any preliminary prospectus has been issued to
the Company, and each preliminary prospectus filed as part of the
Registration Statement as originally filed or as part of any
amendment thereto, or filed pursuant to Rule 424 under the
Securities Act, complied when so filed in all material respects
with the Securities Act and the applicable rules and regulations of
the Commission thereunder.
(o) The Company is not, and
after giving effect to the offering and sale of the Shares and the
application of the proceeds thereof as described in the Prospectus
will not be, required to register as an “investment
company” as such term is defined in the Investment Company
Act of 1940, as amended.
(p) Except as described in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus, the Company and its subsidiaries: (A) are and at
all times have been in material compliance with all statutes,
rules, regulations, or guidances applicable to 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 or such subsidiary (“
Applicable Laws ”); (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 Governmental Authority alleging or
asserting noncompliance with any Applicable Laws or any licenses,
certificates, approvals, authorizations, permits and supplements or
amendments thereto required by any such Applicable Laws necessary
for the conduct of the Company’s business as described in the
Time of Sale Prospectus (“ Authorizations ”);
(C) possess all 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 have no knowledge that any such
Governmental Authority is considering such action; (F) have
filed, obtained, maintained or submitted all 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); and (G) have
6
not,
either voluntarily or involuntarily, initiated, conducted, or
issued or caused to be initiated, conducted or issued, any recall,
market withdrawal or replacement, safety alert, post sale warning,
“dear doctor” letter, or other notice or action
relating to the alleged lack of safety or efficacy of any product
or any alleged product defect or violation and, to the
Company’s and its subsidiaries’ knowledge, no third
party has initiated, conducted or intends to initiate any such
notice or action.
(q) The studies, tests and
preclinical and clinical trials conducted by or on behalf of the
Company or any of its subsidiaries were and, if still pending, are
being conducted in material accordance with experimental protocols,
procedures 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 the rules and regulations promulgated thereunder
(collectively, “ FFDCA ”); the descriptions of
the results of such studies, tests and trials contained in the
Registration Statement, the Time of Sale Prospectus 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 Prospectus 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 Prospectus 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.
(r) The Company and its
subsidiaries (A) are in compliance with any and all applicable
foreign, federal, state and local laws, rules, regulations,
treaties, statutes and codes promulgated by any and all
Governmental Authorities (including pursuant to the Occupational
Health and Safety Act) relating to the protection of human health
and safety in the workplace (“ Occupational Laws
”); (B) have received all material permits, licenses or
other approvals required of it under applicable Occupational Laws
to conduct its business as currently conducted; and (C) are in
compliance with all material terms and conditions of such permits,
licenses or approvals. No action, proceeding, revocation
proceeding, writ, injunction or claim is pending or, to the
Company’s and its subsidiaries’ knowledge, threatened
against the Company or any of its subsidiaries relating to
Occupational Laws, and neither the Company nor its subsidiaries
have knowledge of any facts, circumstances or developments relating
to its or its subsidiaries’ operations or cost accounting
practices that could
7
reasonably be expected to form the basis for or give rise to such
actions, suits, investigations or proceedings.
(s) Each employee benefit plan,
within the meaning of Section 3(3) of the Employee Retirement
Income Security Act of 1974, as amended (“ ERISA
”), that is maintained, administered or contributed to by the
Company or any of its affiliates for employees or former employees
of the Company and its subsidiaries has been maintained in
compliance with its terms and the requirements of any applicable
statutes, orders, rules and regulations, including ERISA and the
Internal Revenue Code of 1986, as amended (the " Code
”). No prohibited transaction, within the meaning of
Section 406 of ERISA or Section 4975 of the Code, has
occurred with respect to any such plan excluding transactions
effected pursuant to a statutory or administrative exemption; and
for each such plan that is subject to the funding rules of
Section 412 of the Code or Section 302 of ERISA, no
“accumulated funding deficiency” as defined in
Section 412 of the Code has been incurred, whether or not
waived, and the fair market value of the assets of each such plan
(excluding for these purposes accrued but unpaid contributions)
exceeds the present value of all benefits accrued under such plan
determined using reasonable actuarial assumptions.
(t) Nothing has come to the
attention of the Company that has caused the Company to believe
that the statistical and market-related data included in the
Registration Statement, the Time of Sale Prospectus and the
Prospectus is not based on or derived from sources that are
reliable and accurate in all material respects.
(u) The Company and its
subsidiaries (i) are in compliance with any and all applicable
foreign, federal, state and local laws and regulations relating to
the protection of human health and safety, the environment or
hazardous or toxic substances or wastes, pollutants or contaminants
(“ Environmental Laws ”), (ii) have
received all permits, licenses or other approvals required of them
under applicable Environmental Laws to conduct their respective
businesses and (iii) are 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, singly or in the aggregate, have a material
adverse effect on the Company and its subsidiaries, taken as a
whole.
(v) 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
8
activities and any potential liabilities to third parties) which
would, singly or in the aggregate, have a material adverse effect
on the Company and its subsidiaries, taken as a whole.
(w) Except as described in the
Time of Sale Prospectus, there are no contracts, agreements or
understandings between the Company and any person granting such
person the right to require the Company to file a registration
statement under the Securities Act with respect to any securities
of the Company or to require the Company to include such securities
with the Shares registered pursuant to the Registration
Statement.
(x) Subsequent to the respective
dates as of which information is given in each of the Registration
Statement, the Time of Sale Prospectus and the Prospectus, except
as described in the Registration Statement, the Time of Sale
Prospectus or the Prospectus collectively, (i) neither the
Company nor any of its subsidiaries has incurred any material
liability or obligation, direct or contingent, nor entered into any
material transaction; (ii) neither the Company nor any of its
subsidiaries has purchased any of its outstanding capital stock
(other than from its employees or service providers in connection
with the termination of their service to the Company or such
subsidiary), nor declared, paid or otherwise made any dividend or
distribution of any kind on its capital stock other than ordinary
and customary dividends; and (iii) there has not been any
material change in the capital stock, short-term debt or long-term
debt of the Company or any of its subsidiaries.
(y) Neither the Company nor any
of its subsidiaries owns any real property. The Company and each of
its subsidiaries has good and marketable title to all personal
property owned by it which is material to the business of the
Company and its subsidiaries, taken as a whole, free and clear of
all liens, encumbrances and defects of title except such as are
described in the Time of Sale Prospectus or such as do not
materially affect the value of such property and do not interfere
with the use made and proposed to be made of such property by the
Company or such subsidiary and any real property and buildings held
under lease by the Company or such subsidiary are held by it under
valid, subsisting and enforceable leases with such exceptions as
are not material and do not interfere with the use made and
proposed to be made of such property and buildings by the Company
or such subsidiary, in each case except as described in the Time of
Sale Prospectus.
(z) Except as disclosed in the
Time of Sale Prospectus, the Company and each of its subsidiaries
owns, possesses rights to use, or can acquire on reasonable terms
rights to use all Intellectual Property (as defined below)
necessary for the conduct of the business of the Company or such
subsidiary as
9
described in the Registration Statement, the Time of Sale
Prospectus and the Prospectus as now conducted or now proposed to
be conducted, and except as would not, individually or in the
aggregate, reasonably be expected to have a material adverse effect
on the Company and its subsidiaries, taken as a whole, or except as
described in the Time of Sale Prospectus, (i) to the knowledge
of the Company or its subsidiaries, there is no infringement,
misappropriation or violation by third parties of any such
Intellectual Property; (ii) there is no pending or, to the
knowledge of the Company or its subsidiaries, threatened action,
suit, proceeding or claim by others challenging the rights of the
Company or any of its subsidiaries in or to any such Intellectual
Property, and the Company is unaware of any facts which would form
a reasonable basis for any such claim; (iii) the Intellectual
Property owned by the Company and each of its subsidiaries and, to
the knowledge of the Company or its subsidiaries, 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 be
reasonably likely to form a basis for any such claim;
(iv) there is no pending or, to the knowledge of the Company
or its subsidiaries, threatened action, suit, proceeding or claim
by others that the Company or any of its subsidiaries infringes,
misappropriates or otherwise violates any Intellectual Property or
other proprietary rights of others, the Company has not received
any written notice of such claim that has not been resolved and the
Company is unaware of any other facts which would form a reasonable
basis for any other such claim; and (v) to the Company’s
or its subsidiaries’ knowledge, no current employee of the
Company or any of its subsidiaries is in or has ever been in
violation of any 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 such subsidiary, or actions undertaken by the
employee while employed with the Company or such subsidiary. The
term “Intellectual Property” as used herein means all
patents, patent applications, trade and service marks, trade and
service mark registrations, trade names, copyrights, licenses,
inventions, trade secrets, know-how and other intellectual
property.
(aa) No material labor dispute
with the employees of the Company or any of its subsidiaries
exists, except as described in the Time of Sale Prospectus, or, to
the knowledge of the Company or its subsidiaries, is imminent; and
neither the Company nor any of its subsidiaries have received any
notice of any existing, threatened or imm
|
