Exhibit
10-9
THE SYMBOL '***' IS USED THROUGHOUT THIS
EXHIBIT TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED
AS CONFIDENTIAL
CONFIDENTIAL
Amendment No.
2
AAC/Baxter Distribution and License
Agreement
AMENDMENT NO. 2 TO DISTRIBUTION AND
LICENSE AGREEMENT
BY AND AMONG:
Angiodevice International
GmbH
(hereinafter
“AAC”)
AND:
Baxter Healthcare
Corporation
Baxter Healthcare, S.A.
(hereinafter
“Baxter”)
WHEREAS, Angiotech Pharmaceuticals, Inc.,
Angiotech International GmbH (now called Angiotech International
AG) and Cohesion Technologies, Inc., on the one hand, and Baxter,
on the other hand, previously executed a Distribution and License
Agreement, effective as of April 1, 2003 (the “Original
Agreement”);
WHEREAS, by assignment, Angiodevice
International GmbH is the successor in interest to all rights and
obligations of Angiotech Pharmaceuticals, Inc., Angiotech
International GmbH (now called Angiotech International AG) and
Cohesion Technologies, Inc. under the Original
Agreement;
WHEREAS, AAC and Baxter previously
amended the Original Agreement by executing Amendment No. 1, dated
December 23, 2004 (hereinafter, the Original Agreement as amended
by Amendment No. 1 shall be referred to as the
“Agreement”);
WHEREAS, by this Amendment No. 2
(“Amendment”), having an effective date of October 8,
2007 (“Amendment Effective Date”), AAC and Baxter now
desire to further amend certain terms and conditions of the
Agreement;
WHEREAS, AAC and Baxter desire that all
other terms and conditions of the Agreement remain in full force
and effect;
NOW, THEREFORE, in consideration of the
promises and mutual covenants hereinafter set forth, the
sufficiency of which is hereby acknowledged, AAC and Baxter hereby
agree as follows:
1.
Capitalized terms in this Amendment shall
have the same meaning as those in the Agreement, unless
specifically defined otherwise in this Amendment. All Article
and Section references shall refer to the corresponding Article and
Section in the Agreement.
2.
Except as expressly modified herein, the
Agreement shall remain in full force and effect in accordance with
its terms. To the extent that there are any inconsistencies
between this
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CONFIDENTIAL
Amendment No.
2
AAC/Baxter Distribution and License
Agreement
Amendment and the Agreement, the terms of this
Amendment shall supersede those set forth in the
Agreement.
3.
Amendments .
3.1
Amendment to Section 2.2(b)
. The penultimate paragraph of
Section 2.2(b) of the Agreement is hereby deleted and restated in
its entirety as follows:
“Upon commencement of the [***]
surgery adhesion prevention study or another adhesion prevention
study, Baxter shall use Commercially Reasonable Efforts to conduct
the applicable study, at its sole expense, and to use the data from
such study to seek FDA approval for the applicable adhesion
prevention indication; provided that Baxter shall not be required,
under any circumstances, to spend more than [***] Dollars ($[***])
to conduct such study. If Baxter seeks FDA approval for a
CoSeal Adhesion Prevention Unit for any adhesion prevention
indication based on data from such study, and provided that AAC and
Baxter have established a revised mutually agreed upon schedule of
CoSeal Unit Minimum Sales as described in Section 5.2(b), the
CoSeal Adhesion Prevention Option described in this Section 2.2(b)
shall be deemed exercised by Baxter upon [***], and in such
circumstances, AAC shall waive Baxter’s obligation to pay the
option exercise fee set forth in Section 9.2(a).
At Baxter’s reasonable request, in
order to assist Baxter in deciding whether to conduct the [***]
surgery adhesion prevention study or another adhesion prevention
study, AAC shall provide to Baxter appropriate AAC research program
data and results that are directly related to AAC’s
Drug-Loaded Product program for adhesion prevention barrier
indications, including, but not limited to, data regarding [***] or
any other molecule. Baxter shall not use such data or results
for any purpose other than its evaluation of whether to conduct the
[***] surgery adhesion prevention study or another adhesion
prevention study, or no study at all. For avoidance of doubt,
the Parties hereby agree that Baxter shall have absolute discretion
in deciding whether to conduct and how to conduct the [***] surgery
adhesion prevention study or another adhesion prevention
study.
Should Baxter fail to seek FDA approval
for the [***] surgery adhesion prevention indication or another
adhesion prevention indication (for example, by discontinuing the
[***] surgery adhesion prevention study, or by failing to use
Commercially Reasonable Efforts to conduct such study or another
adhesion prevention study, or by notifying AAC in writing that
Baxter will not seek FDA approval for a CoSeal Adhesion Prevention
Unit), and in any event if Baxter fails to initiate a [***] surgery
adhesion prevention study by December 31, 2008, then upon written
notice to Baxter, AAC shall have the right to conduct one or more
adhesion prevention studies using the CoSeal Adhesion Prevention
Unit. AAC’s sole
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CONFIDENTIAL
Amendment No.
2
AAC/Baxter Distribution and License
Agreement
and exclusive remedy for Baxter’s
failure to use Commercially Reasonable Efforts to conduct the [***]
surgery adhesion prevention study or another adhesion prevention
study, failure to seek FDA approval for the [***] surgery adhesion
prevention indication or another adhesion prevention indication, or
failure to initiate a [***] surgery adhesion prevention study by
December 31, 2008, shall be AAC’s right to conduct, without
any restrictions or any requirement to consult with Baxter, one or
more adhesion prevention studies using the CoSeal Adhesion
Prevention Unit. If AAC elects to conduct such adhesion
prevention study(ies), AAC may request to use, and Baxter may elect
to provide, clinical study data generated or obtained by Baxter
pursuant to this Section 2.2; provided that, in such event, the
option fee payable by Baxter (as set forth in Section 9.2(a)) shall
be reduced by an amount equal to Baxter’s reasonable
out-of-pocket costs incurred in generating and/or obtaining such
clinical study data (but only to the extent that such data are
provided by Baxter to AAC).
If AAC elects to so conduct one or more
adhesion prevention studies using the CoSeal Adhesion Prevention
Unit(s), Baxter shall have a right to exercise the CoSeal Adhesion
Prevention Option described in this Section 2.2(b) by written
notice to AAC before the later to occur of: (i) [***], and
(ii) [***] (the later to occur of clause (i) and (ii) shall be
referred to herein as the “Option Expiration Date”).
At Baxter’s request before the Option Expiration Date,
AAC shall provide to Baxter appropriate AAC research program data
and results that are directly related to AAC’s Drug-Loaded
Product program for adhesion prevention barrier indications and
that are in AAC’s possession at the time of such request.
Baxter shall not use such data or results for any purpose
other than its evaluation of whether to exercise the CoSeal
Adhesion Prevention Option. This Option Expiration Date may
be extended by mutual written agreement of the Parties. If
Baxter declines or fails to exercise the CoSeal Adhesion Prevention
Option as set forth above, or if the Option Expiration Date passes
before AAC and Baxter have established a mutually agreed upon
schedule of CoSeal Unit Minimum Sales as described in Section
5.2(b), Baxter shall not owe AAC any monetary payments under
Section 9.2(a) and all rights granted to Baxter with respect to the
CoSeal Adhesion Prevention Unit(s) in the Adhesion Prevention
Territory shall immediately terminate and revert to AAC without
necessity of notice.”
3.2
Insertion of New Sections 2.8 and
2.9 . After Section 2.7,
the following new Sections 2.8 and 2.9 are hereby
inserted:
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CONFIDENTIAL
Amendment No.
2
AAC/Baxter Distribution and License
Agreement
2.8
AAC’s Right to Purchase CoSeal
Ingredients and CoSeal Products . During the term of this Agreement, Baxter
shall supply and sell to AAC raw CoSeal Ingredients at [***];
formulated CoSeal Ingredients at [***]; and finished CoSeal Units
at [***]; provided that AAC shall use such raw CoSeal Ingredients,
formulated CoSeal Ingredients and finished CoSeal Units solely for
research, development and/or clinical trial purposes, and shall not
resell such supplied CoSeal Units into the surgical/ hospital
environment in any geographical market. AAC shall indemnify
Baxter for any Third-Party claims that may arise from AAC’s
use or exploitation of the supplied CoSeal Ingredients and CoSeal
Units. AAC shall communicate its supply needs in connection
with this Section 2.8 at least 60 (sixty) days in advance of the
requested delivery date, and Baxter shall use commercially
reasonable, good faith efforts to meet AAC’s supply needs;
provided, however, if AAC’s orders for raw CoSeal
Ingredients, formulated CoSeal Ingredients and/or finished CoSeal
Units in any given calendar quarter should equal or exceed [***],
[***], or [***], respectively, then AAC and Baxter shall cooperate
to ensure an appropriate lead time and delivery date for such
increased quantity of raw CoSeal Ingredients, formulated CoSeal
Ingredients or finished CoSeal Units (as
applicable).”
2.9
Baxter Use of AAC Clinical
Data . Within thirty
(30) days of the Amendment Effective Date, AAC shall provide to
Baxter, free of charge, AAC’s pulmonary surgery clinical
study data regarding CoSeal Sealant Units, which Baxter shall use
solely for the purpose of expanding the CE Mark for the CoSeal
Sealant Unit into thor
