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Exhibit 1.1
OMRIX BIOPHARMACEUTICALS, INC.
3,437,500 Shares
Common Stock
($0.01 par value per Share)
FORM OF UNDERWRITING AGREEMENT
April [11], 2006
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UNDERWRITING AGREEMENT
April [11], 2006
UBS Securities LLC
CIBC World Markets Corp.
Leerink Swann & Company
Oppenheimer & Co. Inc.
as
Representatives of the several Underwriters
c/o UBS Securities LLC
299 Park Avenue
New York, New York 10171-0026
Ladies and Gentlemen:
Omrix Biopharmaceuticals, Inc., a Delaware corporation (the
"Company"), proposes to issue and sell to the underwriters named in
Schedule A
annexed hereto (the "Underwriters"), for whom you are acting as
representatives,
an aggregate of 3,437,500 shares (the "Firm Shares") of common
stock, $0.01 par
value per share (the "Common Stock"), of the Company. In addition,
solely for
the purpose of covering over-allotments, the Company proposes to
grant to the
Underwriters the option to purchase from the Company up to an
additional 515,625
shares of Common Stock (the "Additional Shares"). The Firm Shares
and the
Additional Shares are hereinafter collectively sometimes referred
to as the
"Shares." The Shares are described in the Prospectus which is
referred to below.
The Company has prepared and filed, in accordance with the
provisions of the Securities Act of 1933, as amended, and the rules
and
regulations thereunder (collectively, the "Act"), with the
Securities and
Exchange Commission (the "Commission") a registration statement on
Form S-1
(File No. 333-131107) under the Act, including a prospectus,
relating to the
Shares.
Except where the context otherwise requires, "Registration
Statement," as used herein, means the registration statement, as
amended at the
time of such registration statement's effectiveness for purposes of
Section 11
of the Act, as such section applies to the respective Underwriters
(the
"Effective Time"), including (i) all documents filed as a part
thereof, (ii) any
information contained in a prospectus filed with the Commission
pursuant to Rule
424(b) under the Act and deemed, pursuant to Rule 430A or Rule 430C
under the
Act, to be part of the registration statement at the Effective
Time, and (iii)
any registration statement filed to register the offer and sale of
Shares
pursuant to Rule 462(b) under the Act.
The Company has furnished to you, for use by the Underwriters
and by dealers in connection with the offering of the Shares,
copies of one or
more preliminary prospectuses relating to the Shares. Except where
the context
otherwise requires, "Preliminary Prospectus," as used herein, means
each such
preliminary prospectus, in the form so furnished.
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Except where the context otherwise requires, "Prospectus," as
used herein, means the prospectus 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 (or such earlier time as may be required under the
Act), or, if
no such filing is required, the final prospectus included in the
Registration
Statement at the time it became effective under the Act, in each
case in the
form furnished by the Company to you for use by the Underwriters
and by dealers
in connection with the offering of the Shares.
"Permitted Free Writing Prospectuses," as used herein, means
the documents listed on Schedule B-1 attached hereto and each "road
show" (as
defined in Rule 433 under the Act), if any, related to the offering
of the
Shares contemplated hereby listed on Schedule B-2 attached hereto
(each such
road show, a "Road Show").
"Disclosure Package," as used herein, means any Preliminary
Prospectus together with any combination of one or more of the
Permitted Free
Writing Prospectuses, if any.
As used in this Agreement, "business day" shall mean a day on
which the New York Stock Exchange (the "NYSE") is open for trading.
The terms
"herein," "hereof," "hereto," "hereinafter" and similar terms, as
used in this
Agreement, shall in each case refer to this Agreement as a whole
and not to any
particular section, paragraph, sentence or other subdivision of
this Agreement.
The term "or," as used herein, is not exclusive.
The Company has prepared and filed, in accordance with Section
12 of the Securities Exchange Act of 1934, as amended, and the
rules and
regulations thereunder (collectively, the "Exchange Act"), a
registration
statement (as amended, the "Exchange Act Registration Statement")
on Form 8-A
(File No. [____]) under the Exchange Act to register, under Section
12(g) of the
Exchange Act, the class of securities consisting of the Common
Stock.
The Company and the Underwriters agree as follows:
1. Sale and Purchase. Upon the basis of the representations and
warranties and subject to the terms and conditions herein set
forth, the Company
agrees to issue and sell to the respective Underwriters and each of
the
Underwriters, severally and not jointly, agrees to purchase from
the Company the
number of Firm Shares set forth opposite the name of such
Underwriter in
Schedule A attached hereto, subject to adjustment in accordance
with Section 8
hereof, in each case at a purchase price of $[ ] per Share. The
Company is
advised by you that the Underwriters intend (i) to make a public
offering of
their respective portions of the Firm Shares as soon after the
effective date of
the Registration Statement as in your judgment is advisable and
(ii) initially
to offer the Firm Shares upon the terms set forth in the
Prospectus. You may
from time to time increase or decrease the public offering price
after the
initial public offering to such extent as you may determine.
In addition, the Company hereby grants to the several
Underwriters the option to purchase, and upon the basis of the
representations
and warranties and subject to the terms and conditions herein set
forth, the
Underwriters shall have the right to purchase, severally and
not
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jointly, from the Company, ratably in accordance with the number of
Firm Shares
to be purchased by each of them, all or a portion of the Additional
Shares as
may be necessary to cover over-allotments made in connection with
the offering
of the Firm Shares, at the same purchase price per share to be paid
by the
Underwriters to the Company for the Firm Shares. This option may be
exercised by
UBS Securities LLC ("UBS") on behalf of the several Underwriters at
any time and
from time to time on or before the thirtieth day following the date
of the
Prospectus, by written notice to the Company. Such notice shall set
forth the
aggregate number of Additional Shares as to which the option is
being exercised
and the date and time when the Additional Shares are to be
delivered (any such
date and time being herein referred to as an "additional time of
purchase");
provided, however, that no additional time of purchase shall be
earlier than the
"time of purchase" (as defined below) nor earlier than the second
business day
after the date on which the option shall have been exercised nor
later than the
tenth business day after the date on which the option shall have
been exercised.
The number of Additional Shares to be sold to each Underwriter
shall be the
number which bears the same proportion to the aggregate number of
Additional
Shares being purchased as the number of Firm Shares set forth
opposite the name
of such Underwriter on Schedule A hereto bears to the total number
of Firm
Shares (subject, in each case, to such adjustment as you may
determine to
eliminate fractional shares), subject to adjustment in accordance
with Section 8
hereof.
2. Payment
and Delivery. Payment of the purchase price for the Firm Shares
shall be made to the Company by Federal Funds wire transfer against
delivery of
the certificates for the Firm Shares to you through the facilities
of The
Depository Trust Company ("DTC") for the respective accounts of
the
Underwriters. Such payment and delivery shall be made at 10:00
A.M., New York
City time, on April [18], 2006 (unless another time shall be agreed
to by you
and the Company or unless postponed in accordance with the
provisions of Section
8 hereof). The time at which such payment and delivery are to be
made is
hereinafter sometimes called "the time of purchase." Electronic
transfer of the
Firm Shares shall be made to you at the time of purchase in such
names and in
such denominations as you shall specify.
Payment of the purchase price for the Additional Shares shall
be made at the additional time of purchase in the same manner and
at the same
office as the payment for the Firm Shares. Electronic transfer of
the Additional
Shares shall be made to you at the additional time of purchase in
such names and
in such denominations as you shall specify.
Deliveries of the documents described in Section 6 hereof with
respect to the purchase of the Shares shall be made at the offices
of Dewey
Ballantine LLP at 1301 Avenue of the Americas, New York, New York
10019, at 9:00
A.M., New York City time, on the date of the closing of the
purchase of the Firm
Shares or the Additional Shares, as the case may be.
3.
Representations and Warranties of the Company. The Company
represents
and warrants to and agrees with each of the Underwriters that:
(a) the Registration Statement has been declared effective under
the
Act or,
with respect to any registration statement to be filed to
register
the offer
and sale of Shares pursuant to Rule 462(b) under the Act, will
be filed
with the Commission and become effective under the Act no later
than 10:00
P.M., New York City time, on the
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date of
determination of the public offering price for the Shares; no
stop
order of
the Commission preventing or suspending the use of any
Preliminary Prospectus or Permitted Free Writing Prospectus or
the
effectiveness of the Registration Statement has been issued, and
no
proceedings for such purpose have been instituted or, to the
Company's
knowledge,
are contemplated by the Commission; the Exchange Act
Registration Statement has become effective as provided in Section
12 of
the
Exchange Act;
(b) the Registration Statement complied when it became
effective,
complies
as of the date hereof and, as amended or supplemented, at the
time of
purchase, each additional time of purchase, if any, and 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 Shares, will comply,
in
all
material respects, with the requirements of the Act; the
Registration
Statement
did not, as of the Effective Time, contain an untrue statement
of a
material fact or omit to state a material fact required to be
stated
therein or
necessary to make the statements therein not misleading; each
Preliminary Prospectus complied, at the time it was filed with
the
Commission, and complies as of the date hereof, in all material
respects
with the
requirements of the Act; at no time during the period that
begins
on the
earlier of the date of such Preliminary Prospectus and the date
such
Preliminary Prospectus was filed with the Commission and ends at
the
time of
purchase did or will any Preliminary Prospectus, as then
amended
or
supplemented, include an untrue statement of a material fact or
omit to
state a
material fact necessary in order to make the statements
therein,
in the
light of the circumstances under which they were made, not
misleading, and at no time during such period did or will any
Preliminary
Prospectus, as then amended or supplemented, together with any
combination
of one or
more of the then issued Permitted Free Writing Prospectuses, if
any,
include an untrue statement of a material fact or omit to state
a
material
fact necessary in order to make the statements therein, in the
light of
the circumstances under which they were made, not misleading;
the
Prospectus
will comply, as of its date, the date that it is filed with the
Commission, the time of purchase, each additional time of purchase,
if
any, and
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 Shares, in all
material
respects, with the requirements of the Act (including, without
limitation, Section 10(a) of the Act); at no time during the period
that
begins on
the earlier of the date of the Prospectus and the date the
Prospectus
is filed with the Commission and ends at the later of the time
of
purchase, the latest additional time of purchase, if any, and the
end
of the
period 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 Shares did or
will the
Prospectus, as then amended or supplemented, include an untrue
statement
of a material fact or omit to state a material fact necessary
in
order to
make the statements therein, in the light of the circumstances
under
which they were made, not misleading; at no time during the
period
that
begins on the date of such Permitted Free Writing Prospectus and
ends
at the
time of purchase did or will any Permitted Free Writing
Prospectus,
together
with the then most recent Preliminary Prospectus, include an
untrue
statement of a material fact or omit to state a
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material
fact necessary in order to make the statements therein, in the
light of
the circumstances under which they were made, not misleading;
provided,
however, that the Company makes no representation or warranty
with
respect to any statement contained in the Registration Statement,
any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing
Prospectus
in reliance upon and in conformity with information concerning
an
Underwriter and furnished in writing by or on behalf of such
Underwriter through you to the Company expressly for use in the
Registration Statement, such Preliminary Prospectus, the Prospectus
or
such
Permitted Free Writing Prospectus;
(c) prior to the execution of this Agreement, the Company has
not,
directly
or indirectly, offered or sold any Shares by means of any
"prospectus" (within the meaning of the Act) or used any
"prospectus"
(within
the meaning of the Act) in connection with the offer or sale of
the
Shares, in each case other than the Preliminary Prospectuses and
the
Permitted
Free Writing Prospectuses, if any; the Company has not,
directly
or
indirectly, prepared, used or referred to any Permitted Free
Writing
Prospectus
except in compliance with Rules 164 and 433 under the Act;
assuming
that such Permitted Free Writing Prospectus is accompanied or
preceded
by the most recent Preliminary Prospectus that contains a price
range or
the Prospectus, as the case may be, and that such Permitted
Free
Writing
Prospectus is so sent or given after the Registration Statement
was filed with
the Commission (and after such Permitted Free Writing
Prospectus
was, if required pursuant to Rule 433(d) under the Act, filed
with the
Commission), the sending or giving, by any Underwriter, of any
Permitted
Free Writing Prospectus will satisfy the provisions of Rule 164
and Rule
433 (without reliance on subsections (b), (c) and (d) of Rule
164); the
Preliminary Prospectus dated March 24, 2006 is a prospectus
that,
other than by reason of Rule 433 or Rule 431 under the Act,
satisfies
the requirements of Section 10 of the Act, including a price
range
where required by rule; neither the Company nor the Underwriters
are
disqualified, by reason of subsection (f) or (g) of Rule 164 under
the
Act, from
using, in connection with the offer and sale of the Shares,
"free
writing prospectuses" (as defined in Rule 405 under the Act)
pursuant
to Rules 164 and 433 under the Act; the Company is not an
"ineligible issuer" (as defined in Rule 405 under the Act) as of
the
eligibility determination date for purposes of Rules 164 and 433
under the
Act with
respect to the offering of the Shares contemplated by the
Registration Statement; the parties hereto agree and understand
that the
content of
any and all "road shows" (as defined in Rule 433 under the Act)
related to
the offering of the Shares contemplated hereby is solely the
property
of the Company; the Company has caused there to be made
available
at least
one version of a "bona fide electronic road show" (as defined
in
Rule 433
under the Act) in a manner that, pursuant to Rule 433(d)(8)(ii)
under the
Act, causes the Company not to be required, pursuant to Rule
433(d)
under the Act, to file, with the Commission, any Road Show;
(d) as of the date of this Agreement, the Company has an
authorized
and
outstanding capitalization as set forth in the sections of the
Registration Statement, the Preliminary Prospectuses and the
Prospectus
entitled
"Capitalization" (and any similar sections or information, if
any,
contained in any Permitted Free Writing Prospectus), and, as of
the
time of
purchase and any additional time of purchase, as the case may
be,
the
Company shall have an authorized and outstanding capitalization as
set
forth in
the
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sections
of the Registration Statement and the Prospectus entitled
"Capitalization" (and any similar sections or information, if
any,
contained
in any Permitted Free Writing Prospectus), (subject, in each
case, to
the issuance of shares of Common Stock upon exercise of stock
options,
warrants and convertible promissory notes disclosed as
outstanding in the Registration Statement (excluding the
exhibits
thereto),
each Preliminary Prospectus and the Prospectus and the grant of
options
under existing stock option plans described in the Registration
Statement
(excluding the exhibits thereto), each Preliminary Prospectus
and the
Prospectus); all of the issued and outstanding shares of
capital
stock,
including the Common Stock, of the Company have been duly
authorized
and validly issued and are fully paid and non-assessable, have
been
issued in compliance with all federal and state securities laws
and
were not
issued in violation of any preemptive right, resale right,
right
of first
refusal or similar right; no further approval or authority of
the
stockholders or the Board of Directors of the Company are required
for the
issuance
and sale of the Shares; and the second amended and restated
certificate of incorporation of the Company and the second amended
and
restated
bylaws of the Company, each in the form filed as an exhibit to
the
Registration Statement, have been heretofore duly authorized
and
approved
in accordance with the Delaware General Corporation Law and
shall
become
effective and in full force and effect on or before the time of
purchase;
the Shares are duly listed, and admitted and authorized for
trading,
subject to official notice of issuance and evidence of
satisfactory distribution on the Nasdaq National Market
("NASDAQ");
(e) the Company has been duly incorporated and is validly
existing
as a
corporation in good standing under the laws of the State of
Delaware,
with full
corporate power and authority to own, lease and operate its
properties
and conduct its business as described in the Registration
Statement,
the Preliminary Prospectuses, the Prospectus and the Permitted
Free
Writing Prospectuses, if any, to execute and deliver this
Agreement
and to
issue, sell and deliver the Shares as contemplated herein;
(f) the Company is duly qualified to do business as a foreign
corporation and is in good standing in each jurisdiction where
the
ownership
or leasing of its properties or the conduct of its business
requires
such qualification, except where the failure to be so qualified
and in
good standing would not, individually or in the aggregate, have
a
material
adverse effect on the business, properties, financial
condition,
results of
operations or prospects of the Company and the Subsidiaries (as
hereinafter defined) taken as a whole (a "Material Adverse
Effect"), which
jurisdictions are listed on Schedule C attached hereto;
(g) the Company has no subsidiaries (as defined under the Act)
other
than Omrix
Biopharmaceuticals S.A., Omrix Biopharmaceuticals Ltd. and
Biopex
Ltd. (collectively, the "Subsidiaries"); the Company directly
or
indirectly
owns all of the issued and outstanding capital stock of each of
the
Subsidiaries; except as disclosed in the Registration Statement
(excluding
the exhibits thereto), the Preliminary Prospectus and the
Prospectus, other than the capital stock of the Subsidiaries, the
Company
does not
own, directly or indirectly, any shares of stock or any other
equity or
long-term debt securities of any corporation or have any equity
interest
in any firm, partnership, joint venture, association or other
entity, other
than 212,866 shares of common stock of Symphony
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Medical
Inc.; complete and correct copies of the certificates of
incorporation and the bylaws of the Company and each Subsidiary and
all
amendments
thereto have been delivered to you, and, except as set forth in
the
exhibits to the Registration Statement, no changes therein will
be
made on or
before the time of purchase or, if later, any additional time
of purchase; each
Subsidiary has been duly incorporated and is validly
existing
as a corporation in good standing under the laws of the
jurisdiction of its incorporation, with full corporate power and
authority
to own,
lease and operate its properties and to conduct its business as
described
in the Registration Statement, the Preliminary Prospectuses,
the
Prospectus
and the Permitted Free Writing Prospectuses, if any; each
Subsidiary
is duly qualified to do business as a foreign corporation and
is in good
standing in each jurisdiction where the ownership or leasing of
its
properties or the conduct of its business requires such
qualification,
except
where the failure to be so qualified and in good standing would
not,
individually or in the aggregate, have a Material Adverse Effect;
all
of the
outstanding shares of capital stock of each of the Subsidiaries
have been
duly authorized and validly issued, are fully paid and
non-assessable, were not issued in violation of any preemptive
right,
resale
right, right of first refusal or similar right and, except as
disclosed
in the Registration Statement (excluding the exhibits thereto),
the
Preliminary Prospectus and the Prospectus, are owned by the
Company
subject to
no security interest, other encumbrance or adverse claims; and
no
options, warrants or other rights to purchase, agreements or
other
obligations to issue or other rights to convert any obligation into
shares
of capital
stock or ownership interests in the Subsidiaries are
outstanding;
(h) the Shares have been duly and validly authorized and, when
issued and
delivered against payment therefor as provided herein, will be
duly and
validly issued, fully paid and non-assessable and free of
statutory
and contractual preemptive rights, resale rights, rights of
first
refusal and similar rights; the Shares, when issued and
delivered
against
payment therefor as provided herein, will be free of any
restriction upon the voting or transfer thereof pursuant to the
Company's
charter or
bylaws or any agreement or other instrument to which the
Company is
a party;
(i) the capital stock of the Company, including the Shares,
conforms
in all
material respects to the description thereof contained in the
Registration Statement, any Preliminary Prospectus, the Prospectus
or any
Permitted
Free Writing Prospectus; the certificates for the Shares are in
due and
proper form; and the holders of the Shares will not be subject
to
personal
liability solely by reason of being such holders;
(j) this Agreement has been duly authorized, executed and
delivered
by the
Company;
(k) neither the Company nor any of the Subsidiaries is in breach
or
violation
of or in default under (nor has any event occurred which with
notice,
lapse of time or both would result in any breach or violation
of,
constitute
a default under or give the holder of any indebtedness (or a
person
acting on such holder's behalf) the right to require the
repurchase, redemption or repayment of all or a part of such
indebtedness
under) (A)
its respective charter or bylaws, or (B) any indenture,
mortgage,
deed of trust,
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bank loan
or credit agreement or other evidence of indebtedness, or any
license,
lease, contract or other agreement or instrument to which the
Company or
any of the Subsidiaries is a party or by which any of them or
any of
their respective properties may be bound or affected, or (C)
any
federal,
state, local or foreign law, regulation or rule, or (D) any
rule
or
regulation of any regulatory organization having jurisdiction over
the
Company or
its business (including, without limitation, the rules and
regulations of the NASDAQ), or (E) any decree, judgment or
order
applicable
to the Company or any of the Subsidiaries or any of their
respective
properties; except, with respect to clauses (B), (C), (D) or
(E), where
such breach, violation or default would not, individually or in
the
aggregate, have a Material Adverse Effect;
(l) the execution, delivery and performance of this Agreement,
the
issuance
and sale of the Shares and the consummation of the transactions
contemplated hereby will not conflict with, result in any breach
or
violation of or
constitute a default under (nor constitute any event which
with
notice, lapse of time or both would result in any breach or
violation
of or
constitute a default under or give the holder of any
indebtedness
(or a
person acting on such holder's behalf) the right to require the
repurchase, redemption or repayment of all or a part of such
indebtedness
under) (or
result in the creation or imposition of a lien, charge or
encumbrance on any property or assets of the Company or any
Subsidiary
pursuant
to) (A) the charter or bylaws of the Company or any of the
Subsidiaries, or (B) any indenture, mortgage, deed of trust, bank
loan or
credit
agreement or other evidence of indebtedness, or any license,
lease,
contract
or other agreement or instrument to which the Company or any of
the
Subsidiaries is a party or by which any of them or any of their
respective
properties may be bound or affected, or (C) any federal, state,
local or
foreign law, regulation or rule, or (D) any decree, judgment or
order
applicable to the Company or any of the Subsidiaries or any of
their
respective
properties;
(m) no approval, authorization, consent or order of or filing
with
any
federal, state, local or foreign governmental or regulatory
commission, board, body, authority or agency, or of or with any
self-regulatory organization or other non-governmental
regulatory
authority
(including, without limitation, NASDAQ), is required in
connection
with the issuance and sale of the Shares or the consummation by
the
Company of the transactions contemplated hereby other than
registration of the Shares under the Act, which has been effected,
and any
necessary
qualification under the securities or blue sky laws of the
various
jurisdictions in which the Shares are being offered by the
Underwriters or under the rules and regulations of the NASDAQ or
the
National
Association of Securities Dealers, Inc. (the "NASD"); ----
(n) except as described in the Registration Statement (excluding
the
exhibits
thereto), each Preliminary Prospectus and the Prospectus, (i)
no
person has
the right, contractual or otherwise, to cause the Company to
issue or
sell to it any shares of Common Stock or shares of any other
capital
stock or other equity interests of the Company, (ii) no person
has
any
preemptive rights, resale rights, rights of first refusal or
other
rights to
purchase any shares of Common Stock or shares of any other
capital
stock of or other equity interests in the Company and (iii) no
person has
the right to act as an
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underwriter or as a
financial advisor to the Company in connection with
the offer
and sale of the Shares, in the case of each of the foregoing
clauses
(i), (ii) and (iii), whether as a result of the filing or
effectiveness of the Registration Statement or the sale of the
Shares as
contemplated thereby or otherwise; no person has the right,
contractual or
otherwise,
to cause the Company to register under the Act any shares of
Common
Stock or shares of any other capital stock of or other equity
interests
in the Company, or to include any such shares or interests in
the
Registration Statement or the offering contemplated thereby,
whether
as a
result of the filing or effectiveness of the Registration
Statement
or the
sale of the Shares as contemplated thereby or otherwise;
(o) each of the Company and the Subsidiaries has all necessary
licenses,
authorizations, consents and approvals and has made all
necessary
filings required under any federal, state, local or foreign
law,
regulation
or rule, and has obtained all necessary licenses,
authorizations, consents and approvals from other persons, in order
to
conduct
its respective business; neither the Company nor any of the
Subsidiaries is in violation of, or in default under, or has
received
notice of
any proceedings relating to revocation or modification of, any
such
license, authorization, consent or approval or any federal,
state,
local or
foreign law, regulation or rule or any decree, order or
judgment
applicable
to the Company or any of the Subsidiaries, except where such
violation,
default, revocation or modification would not, individually or
in the
aggregate, have a Material Adverse Effect;
(p) all legal or governmental proceedings, affiliate
transactions,
off-balance sheet transactions, contracts, licenses,
agreements,
properties, leases or documents of a character required to be
described in
the
Registration Statement or the Prospectus or to be filed as an
exhibit
to the
Registration Statement have been so described or filed as
required;
(q) there are no actions, suits, claims, investigations or
proceedings pending or, to the Company's knowledge, threatened
or
contemplated to which the Company or any of the Subsidiaries or any
of
their
respective directors or officers is or would be a party or of
which
any of
their respective properties is or would be subject at law or in
equity,
before or by any federal, state, local or foreign governmental
or
regulatory
commission, board, body, authority or agency, except any such
action,
suit, claim, investigation or proceeding which would not result
in
a
judgment, decree or order having, individually or in the aggregate,
a
Material
Adverse Effect;
(r) each of Kost Forer Gabbay & Kasierer, a Member of Ernst
& Young
Global and
Ziv Haft, a BDO member firm, whose reports on the consolidated
financial
statements of the Company and the Subsidiaries are included in
the
Registration Statement, the Preliminary Prospectuses, the
Prospectus
and
Permitted Free Writing Prospectuses, if applicable, is an
independent
registered
public accounting firm as required by the Act and by the rules
of the
Public Company Accounting Oversight Board;
(s) the financial statements included in the Registration
Statement,
any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing
Prospectus, together with the related notes and schedules, present
fairly
the
consolidated financial
-9-
<PAGE>
position
of the Company and the Subsidiaries as of the dates indicated
and
the
consolidated results of operations, cash flows and changes in
stockholders' equity of the Company and the Subsidiaries for the
periods
specified
and have been prepared in compliance with the requirements of
the Act
and the Exchange Act and in conformity with U.S. generally
accepted
accounting principles applied on a consistent basis during the
periods
involved; there are no financial statements (historical or pro
forma)
that are required to be included in the Registration Statement,
any
Preliminary Prospectus or the Prospectus that are not included
as
required;
the Company and the Subsidiaries do not have any material
liabilities or obligations, direct or contingent (including any
off-balance sheet obligations), not disclosed in the
Registration
Statement
(excluding the exhibits thereto), each Preliminary Prospectus
and the
Prospectus; and there are no disclosures in the Registration
Statement, any
Preliminary Prospectus, the Prospectus or any Permitted
Free
Writing Prospectus regarding "non-GAAP financial measures" (as
such
term is
defined by the rules and regulations of the Commission);
(t) subsequent to the respective dates as of which information
is
given in
the Registration Statement, the Preliminary Prospectuses, the
Prospectus
and the Permitted Free Writing Prospectuses, if any, in each
case
excluding any amendments or supplements to the foregoing made
after
the
execution of this Agreement, there has not been (i) any
material
adverse
change, or any development involving a prospective material
adverse
change, in the business, properties, management, financial
condition
or results of operations of the Company and the Subsidiaries
taken as a
whole, (ii) any transaction which is material to the Company
and the
Subsidiaries taken as a whole, (iii) any obligation or
liability,
direct or
contingent (including any off-balance sheet obligations),
incurred
by the Company or any Subsidiary, which is material to the
Company
and the Subsidiaries taken as a whole, (iv) any change in the
capital
stock or material adverse change in the outstanding
indebtedness
of the
Company or any Subsidiaries or (v) any dividend or distribution
of
any kind
declared, paid or made on the capital stock of the Company or
any
Subsidiary;
(u) the Company has obtained for the benefit of the Underwriters
the
agreement
(a "Lock-Up Agreement"), in the form set forth as Exhibit A
hereto, of
(i) each of its directors and officers and (ii) each holder of
shares of
Common Stock or any security convertible into or exercisable or
exchangeable for Common Stock or any warrant or other right to
purchase
Common
Stock or any such security;
(v) neither the Company nor any Subsidiary is, and, solely
after
giving
effect to the offering and sale of the Shares and the
application
of the
proceeds therefrom as described in the Registration Statement,
the
Preliminary Prospectus and the Prospectus, neither of them will be
an
"investment company" as such term is defined in the
-10-
<PAGE>
Investment
Company Act of 1940, as amended (the "Investment Company Act");
(w) the Company and each of the Subsidiaries has good and
marketable
title to
all property (real and personal) described the Registration
Statement,
any Preliminary Prospectus, the Prospectus or any Permitted
Free
Writing Prospectus as being owned by each of them, and except
as
described
in the Registration Statement (excluding the exhibits thereto),
each Preliminary
Prospectus and the Prospectus, free and clear of all
liens,
claims, security interests or other encumbrances; all the
property
described
in the Registration Statement, any Preliminary Prospectus, the
Prospectus
or any Permitted Free Writing Prospectus as being held under
lease by
the Company or a Subsidiary is held thereby under valid,
subsisting
and enforceable leases;
(x) (i) the Company and the Subsidiaries own, or have obtained
valid
and
enforceable licenses for, or other rights to use, the
inventions,
patent
applications, patents, trademarks (both registered and
unregistered), tradenames, service names, copyrights, trade secrets
and
other
proprietary information described in the Registration Statement,
any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing
Prospectus
as being owned or licensed by them or which are necessary for
the
conduct of their respective businesses (including the
commercialization of products or services described in the
Registration
Statement,
any Preliminary Prospectus, the Prospectus or any Permitted
Free
Writing Prospectus as under development) (collectively,
"Intellectual
Property"), except where the failure to own, license or have such
rights
would not,
individually or in the aggregate, have a Material Adverse
Effect;
(ii) there are no third parties who have or, to the Company's
knowledge,
will be able to establish rights to any Intellectual Property,
except for
the ownership rights of the owners of the Intellectual Property
which is
licensed to the Company; (iii) to the Company's knowledge,
there
is no
infringement by third parties of any Intellectual Property;
(iv)
there is
no pending or, to the Company's knowledge, threatened action,
suit,
proceeding or claim by others challenging the Company's rights in
or
to any
Intellectual Property, and the Company is unaware of any facts
which could form a
reasonable basis for any such action, suit, proceeding
or claim;
(v) there is no pending or, to the Company's knowledge,
threatened
action, suit, proceeding or claim by others challenging the
validity
or scope of any Intellectual Property, and the Company is
unaware
of any
facts which could form a reasonable basis for any such action,
suit,
proceeding or claim; (vi) there is no pending or, to the
Company's
knowledge,
threatened action, suit, proceeding or claim by others that the
Company or
any Subsidiary infringes or otherwise violates, or would, upon
the
commercialization of any product or service described in the
Registration Statement, any Preliminary Prospectus, the Prospectus
or any
Permitted
Free Writing Prospectus as under development, infringe or
violate,
any patent, trademark, tradename, service name, copyright,
trade
secret or
other proprietary rights of others, and the Company is unaware
of any
facts which could form a reasonable basis for any such action,
suit,
proceeding or claim; (vii) except as would not have, individually
or
in the
aggregate, a Material Adverse Effect, the Company and the
Subsidiaries have complied with the terms of any agreement pursuant
to
which
Intellectual Property has been licensed to the Company or any
Subsidiary, and to the Company's knowledge all such agreements are
in full
force and
effect; (viii) to the Company's knowledge, and except as would
not have,
individually or in the aggregate, a
-11
<PAGE>
Material
Adverse Effect, there is no patent or patent application that
contains
claims that interfere with the issued or pending claims of any
of
the
Intellectual Property or that adversely affects the validity,
enforceability or scope of any of the Intellectual Property; (ix)
to the
Company's
knowledge, there is no prior art that may render any patent
application within the Intellectual Property unpatentable that has
not
been
disclosed to the U.S. Patent and Trademark Office; and (x) the
product
candidates described in the Registration Statement, any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing
Prospectus
as under development by the Company or any Subsidiary fall
within the
scope of the Intellectual Property owned by, or exclusively
licensed
to, the Company or any Subsidiary;
(y) neither the Company nor any of the Subsidiaries is engaged
in
any unfair
labor practice; except for matters which would not,
individually or in the aggregate, have a Material Adverse Effect,
(i)
there is
(A) no unfair labor practice complaint pending or, to the
Company's
knowledge, threatened against the Company or any of the
Subsidiaries before the National Labor Relations Board, and no
grievance
or
arbitration proceeding arising out of or under collective
bargaining
agreements
is pending or, to the Company's knowledge, threatened, (B) no
strike,
labor dispute, slowdown or stoppage pending or, to the
Company's
knowledge,
threatened against the Company or any of the Subsidiaries and
(C) no
union representation dispute currently existing concerning the
employees
of the Company or any of the Subsidiaries, and (ii) to the
Company's
knowledge, (A) no union organizing activities are currently
taking
place concerning the employees of the Company or any of the
Subsidiaries and (B) there has been no violation of any federal,
state,
local or
foreign law relating to discrimination in the hiring, promotion
or pay of
employees, any applicable wage or hour laws or any provision of
the Employee
Retirement Income Security Act of 1974 ("ERISA") or the rules
and
regulations promulgated thereunder concerning the employees of
the
Company or
any of the Subsidiaries;
(z) the Company and the Subsidiaries and their properties,
assets
and
operations each is in compliance with, and holds all permits,
authorizations and approvals required under, Environmental Laws
(as
defined
below), except to the extent that failure to so comply or to
hold
such
permits, authorizations or approvals would not, individually or
in
the
aggregate, have a Material Adverse Effect; there are no past,
present
or, to the
Company's knowledge, reasonably anticipated future events,
conditions, circumstances, activities, practices, actions,
omissions or
plans that
could reasonably be expected to give rise to any material costs
or
liabilities to the Company or any Subsidiary under, or to
interfere
with or
prevent compliance by the Company or any Subsidiary with,
Environmental Laws; except as would not, individually or in the
aggregate,
have a
Material Adverse Effect, neither the Company nor any of the
Subsidiaries (i) is the subject of any investigation, (ii) has
received
any notice or
claim, (iii) is a party to or affected by any pending or, to
the
Company's knowledge, threatened action, suit or proceeding, (iv)
is
bound by
any judgment, decree or order or (v) has entered into any
agreement,
in each case relating to any alleged violation of any
Environmental Law or any actual or alleged release or threatened
release
or cleanup
at any location of any Hazardous Materials (as defined below)
(as used
herein, "Environmental Law" means
-12-
<PAGE>
any
federal, state, local or foreign law, statute, ordinance, rule,
regulation, order, decree, judgment, injunction, permit,
license,
authorization or other binding requirement, or common law, relating
to
health,
safety or the protection, cleanup or restoration of the
environment or natural resources, including those relating to
the
distribution, processing, generation, treatment, storage,
disposal,
transportation, other handling or release or threatened release
of
Hazardous
Materials, and "Hazardous Materials" means any material
(including, without limitation, pollutants, contaminants, hazardous
or
toxic
substances or wastes) that is regulated by or may give rise to
liability
under any Environmental Law);
(aa) in the ordinary course of its business, the Company
evaluates
the effect
of the Environmental Laws on the Company's and the
Subsidiaries' business, operations and properties and the
associated costs
and
liabilities (including, without limitation, any capital or
operating
expenditures required for cleanup, closure of properties or
compliance
with the
Environmental Laws or any permit, license or approval, any
related
constraints on operating activities and any potential
liabilities
to third
parties);
(bb) all tax returns required to be filed by the Company or any
of
the
Subsidiaries have been timely filed (within time limit
extensions
permitted
by the relevant tax authorities), and all taxes and other
assessments of a similar nature (whether imposed directly or
through
withholding) including any interest, additions to tax or
penalties
applicable
thereto due or claimed to be due from such entities have been
timely
paid, other than those being contested in good faith and for
which
adequate
reserves have been provided and except where the failure to
file
such
returns or to pay such taxes would not, individually or in the
aggregate,
have a Material Adverse Effect;
(cc) the Company maintains insurance covering the Company's and
each
of the
Subsidiaries' respective properties, operations, personnel and
businesses
as the Company reasonably deems adequate; such insurance
insures
against such losses and risks to an extent which is adequate in
accordance
with customary industry practice to protect the Company and the
Subsidiaries and their businesses; all such insurance is fully in
force on
the date
hereof and will be fully in force at the time of purchase and
any
additional
time of purchase;
(dd) neither the Company nor any of the Subsidiaries has
sustained
since the
date of the last audited financial statements included in the
Registration Statement, the Preliminary Prospectuses and the
Prospectus
any loss
or interference with its respective business from fire,
explosion,
flood or other calamity, whether or not covered by insurance,
or from
any labor dispute or court or governmental action, order or
decree;
(ee) neither the Company nor any Subsidiary has sent or received
any
communication regarding termination of, or intent not to renew, any
of the
contracts
or agreements referred to or described in any Preliminary
Prospectus, the Prospectus or any Permitted Free Writing
Prospectus, or
referred
to or described in, or filed as an exhibit to, the Registration
Statement,
and no such termination or non-renewal has been threatened by
the
Company or any Subsidiary or, to the Company's knowledge, any
other
party
to
-13-
<PAGE>
any such
contract or agreement;
(ff) the Company and each of the Subsidiaries maintains a system
of
internal
accounting controls sufficient to provide reasonable assurance
that (i)
transactions are executed in accordance with management's
general
or
specific authorization; (ii) transactions are recorded as necessary
to
permit
preparation of financial statements in conformity with
generally
accepted
accounting principles and to maintain accountability for
assets;
(iii)
access to assets is permitted only in accordance with
management's
general or
specific authorization; and (iv) the recorded accountability
for assets
is compared with existing assets at reasonable intervals and
appropriate action is taken with respect to any differences;
(gg) the Company has established and maintains "disclosure
controls
and
procedures" (as such term is defined in Rule 13a-15 and 15d-15
under
the
Exchange Act); such disclosure controls and procedures are designed
to
ensure
that material information relating to the Company, including
its
consolidated subsidiaries, is made known to the Company's Chief
Executive
Officer
and its Chief Financial Officer by others within those
entities,
and such
disclosure controls and procedures are effective to perform the
functions
for which they were established; the Company's independent
auditors
and the Audit Committee of the Board of Directors of the
Company
have been
advised of: (i) all significant deficiencies, if any, in the
design or
operation of internal controls which could adversely affect the
Company's
ability to record, process, summarize, and report financial
data; and
(ii) all fraud, if any, whether or not material, that involves
management
or other employees who have a role in the Company's internal
controls;
all material weaknesses, if any, in internal controls have been
identified
to the Company's independent auditors; and since the date of
the most
recent evaluation of such disclosure controls and procedures
and
internal
controls, there have been no significant changes in internal
controls
or in other factors that could significantly affect internal
controls,
including any corrective actions with regard to significant
deficiencies and material weaknesses;
(hh) all statistical or market-related data included in the
Registration Statement, any Preliminary Prospectus, the Prospectus
or any
Permitted
Free Writing Prospectus are based on or derived from sources
that the
Company believes to be reliable and accurate, and the Company
has
obtained
the written consent to the use of such data from such sources
to
the extent
required;
(ii) neither the Company nor any of the Subsidiaries nor, to
the
knowledge
of the Company, any director, officer, agent, employee or
affiliate
of the Company or any of the Subsidiaries is aware of or has
taken any
action, directly or indirectly, that would result in a
violation
by such
persons of the Foreign Corrupt Practices Act of 1977, as
amended,
and the
rules and regulations thereunder (the "Foreign Corrupt
Practices
Act"); and
the Company, the Subsidiaries and, to the knowledge of the
Company,
its affiliates have instituted and maintain policies and
procedures
designed to ensure continued compliance therewith;
-14-
<PAGE>
(jj) to the Company's knowledge, the operations of the Company
and
the
Subsidiaries are and have been conducted at all times in
compliance
with
applicable financial recordkeeping and reporting requirements of
the
Currency
and Foreign Transactions Reporting Act of 1970, as amended, the
money
laundering statutes of all jurisdictions, the rules and
regulations
thereunder
and any related or similar rules, regulations or guidelines,
issued,
administered or enforced by any governmental agency
(collectively,
the "Money
Laundering Laws"); and no action, suit or proceeding by or
before any
court or governmental agency, authority or body or any
arbitrator
or non-governmental authority involving the Company or any of
the Subsidiaries with
respect to the Money Laundering Laws is pending or,
to the
Company's knowledge, threatened;
(kk) neither the Company nor any of the Subsidiaries nor, to
the
knowledge
of the Company, any director, officer, agent, employee or
affiliate
of the Company or any of the Subsidiaries is currently subject
to any
U.S. sanctions administered by the Office of Foreign Assets
Control
of the
U.S. Treasury Department ("OFAC"); and the Company will not
directly
or indirectly use the proceeds of the offering of the Shares
contemplated hereby, or lend, contribute or otherwise make
available such
proceeds
to any Subsidiary, joint venture partner or other person or
entity for
the purpose of financing the activities of any person currently
subject to
any U.S. sanctions administered by OFAC;
(ll) the preclinical tests and clinical trials conducted by or
on
behalf of
the Company that are described in, or the results of which are
referred
to in, the Registration Statement, any Preliminary Prospectus,
the
Prospectus or any Permitted Free Writing Prospectus were and, if
still
pending,
are being conducted in accordance with experimental protocols,
procedures
and controls filed with the appropriate regulatory authorities
for each
such test or trial, as the case may be; the description of the
results of
such tests and trials contained in the Registration Statement,
any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing
Prospectus
are accurate in all material respects and fairly present the
data
derived from such tests and trials, and the Company and the
Subsidiaries have no knowledge of any other published or
otherwise
publicly
available studies or tests the results of which are
inconsistent
with, or
otherwise call into question, the results described or referred
to in the
Registration Statement, any Preliminary Prospectus, the
Prospectus
or any Permitted Free Writing Prospectus; neither the Company
nor any
Subsidiaries has received any notices or other correspondence
from
the Food
and Drug Administration of the U.S. Department of Health and
Human
Services or any committee thereof or from any other U.S. or
foreign
government
or drug or medical device regulatory agency requiring the
termination, suspension or material modification of any clinical
trials
conducted
by or on behalf of the Company that are described in the
Registration Statement, any Preliminary Prospectus, the Prospectus
or any
Permitted
Free Writing Prospectus; and the Company and the Subsidiaries
have each
operated and currently are in compliance in all material
respects with
all applicable rules, regulations and policies of the U.S.
Food and
Drug Administration and comparable foreign drug or medical
device
regulatory
agencies outside of the United States;
(mm) the issuance and sale of the Shares as contemplated hereby
will
not cause
any holder of any shares of capital stock, securities
convertible into or exchangeable or
-15-
<PAGE>
exercisable for capital stock or options, warrants or other rights
to
purchase
capital stock or any other securities of the Company to have
any
right to
acquire any shares of preferred stock of the Company;
(nn) except pursuant to this Agreement, neither the Company nor
any
of the
Subsidiaries has incurred any liability for any finder's or
broker's
fee or agent's commission in connection with the execution and
delivery
of this Agreement or the consummation of the transactions
contemplated hereby or by the Registration Statement;
(oo) neither the Company nor any of the Subsidiaries nor any of
their
respective directors, officers, affiliates or controlling
persons
has taken,
directly or indirectly, any action designed, or which has
constituted or might reasonably be expected to cause or result in
the
stabilization or manipulation of the price of any security of the
Company
to
facilitate the sale or resale of the Shares; and
(pp) to the Company's knowledge, there are no affiliations or
associations between (i) any member of the NASD and (ii) the
Company or
any of the
Company's officers, directors, 5% or greater security holders
or any
beneficial owner of the Company's unregistered equity
securities
that were
acquired at any time on or after the 180th day immediately
preceding
the date the Registration Statement was initially filed with
the
Commission, except as disclosed in the Registration Statement
(excluding
the
exhibits thereto), the Preliminary Prospectuses and the
Prospectus.
In
addition, any certificate signed by any officer of the Company
and
delivered to the Underwriters or counsel for the Underwriters in
connection with
the offering of the Shares shall be deemed to be a representation
and warranty
by the Company, as to matters covered thereby, to each
Underwriter.
4. Certain
Covenants of the Company. The Company hereby agrees:
(a) to furnish such information as may be required and otherwise
to
cooperate
in qualifying the Shares for offering and sale under the
securities
or blue sky laws of such states or other jurisdictions as you
may
designate and to maintain such qualifications in effect so long as
you
may
request for the distribution of the Shares; provided, however,
that
the
Company shall not be required to qualify as a foreign corporation
or
to consent
to the service of process under the laws of any such
jurisdiction (except service of process with respect to the
offering and
sale of
the Shares); and to promptly advise you of the receipt by the
Company of
any notification with respect to the suspension of the
qualification of the Shares for offer or sale in any jurisdiction
or the
initiation
or threatening of any proceeding for such purpose;
(b) to make available to the Underwriters in New York City, as
soon
as
practicable after this Agreement becomes effective, and thereafter
from
time to
time to furnish to the Underwriters, as many copies of the
Prospectus
(or of the Prospectus as amended or supplemented if the Company
shall have
made any amendments or supplements thereto after the effective
date of
the Registration Statement) as the
-16-
<PAGE>
Underwriters may request for the purposes contemplated by the Act;
in case
any
Underwriter is required to deliver (whether physically or
through
compliance
with Rule 172 under the Act or any similar rule) a prospectus
after the
nine-month period referred to in Section 10(a)(3) of the Act in
connection
with the sale of the Shares, the Company will prepare, at its
expense,
promptly upon request such amendment or amendments to the
Registration Statement and the Prospectus as may be necessary to
permit
compliance
with the requirements of Section 10(a)(3) of the Act;
(c) if, at the time this Agreement is executed and delivered, it
is
necessary
for a post-effective amendment to the Registration Statement,
or
a
Registration Statement under Rule 462(b) under the Act, to be filed
with
the
Commission and become effective before the Shares may be sold,
the
Company
will use its best efforts to cause such post-effective
amendment
or such
Registration Statement to be filed and become effective as soon
as
possible,
and the Company will advise you promptly and, if requested by
you, will
confirm such advice in writing, (i) when such post-effective
amendment
or such Registration Statement has become effective, and (ii)
if
Rule 430A
under the Act is used, when the Prospectus is filed with the
Commission
pursuant to Rule 424(b) under the Act (which the Company agrees
to file in
a timely manner in accordance with such Rules);
(d) to advise you promptly, confirming such advice in writing,
of
any
request by the Commission for amendments or supplements to the
Registration Statement or the Exchange Act Registration Statement,
any
Preliminary Prospectus, the Prospectus or any Permitted Free
Writing
Prospectus
or for additional information with respect thereto, or of
notice of
institution of proceedings for, or the entry of a stop order,
suspending
the effectiveness of the Registration Statement and, if the
Commission
should enter a stop order suspending the effectiveness of the
Registration Statement, to use its best efforts to obtain the
lifting or
removal of
such order as soon as possible; to advise you promptly of any
proposal
to amend or supplement the Registration Statement or the
Exchange
Act
Registration Statement, any Preliminary Prospectus or the
Prospectus,
and to provide
you and Underwriters' counsel copies of any such documents
for review
and comment a reasonable amount of time prior to any proposed
filing and
to file no such amendment or supplement to which you shall
object in
writing;
(e) subject to Section 4(d) hereof, to file promptly all reports
and
documents
and any preliminary or definitive proxy or information
statement
required
to be filed by the Company with the Commission in order to
comply
with the
Exchange Act for so long as 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 Shares;
and to
provide you with a copy of such reports and statements and
other
documents
to be filed by the Company pursuant to Se
