Exhibit
10.3
THE SYMBOL ‘***’ IS USED
THROUGHOUT THIS EXHIBIT TO INDICATE THAT A PORTION OF THE EXHIBIT
HAS BEEN OMITTED AS CONFIDENTIAL.
SEPTEMBER 24, 2004 AMENDMENT
BETWEEN
ANGIOTECH PHARMACEUTICALS, INC.
AND
COOK INCORPORATED MODIFYING JULY 9,
1997 LICENSE AGREEMENT AMONG ANGIOTECH PHARMACEUTICALS, INC.,
BOSTON SCIENTIFIC CORPORATION, AND COOK INCORPORATED
This Amendment is made and entered into
as of this 24th day of September, 2004 (the “Effective
Date”), by and between Angiotech Pharmaceuticals, Inc., a
corporation organized under the laws of the Province of British
Columbia (“Angiotech”), and Cook Incorporated, an
Indiana corporation (“Cook”).
WHEREAS, Angiotech, Cook, and Boston
Scientific Corporation (“BSC”) entered into the
“License Agreement Among Angiotech Pharmaceuticals, Inc.,
Boston Scientific Corporation and Cook Incorporated” dated
July 9, 1997, under which Angiotech agreed to license on a
co-exclusive basis to Cook and BSC certain patent rights, license
rights, and technology relating to the use of paclitaxel or certain
other agents as a coating for certain medical devices, and Cook and
Angiotech have amended that agreement on September 8, 2001 and June
12, 2002 (collectively, the “Angiotech License
Agreement”);
WHEREAS, the parties have differed in
their respective interpretations of the rights and obligations
arising under Section 9.1(e) of the Angiotech License Agreement (as
amended June 12, 2002); and
WHEREAS, as provided herein, Angiotech
and Cook desire to resolve those differences and further amend the
Angiotech License Agreement to modify certain rights and licenses
granted to Cook;
NOW THEREFORE, Angiotech and Cook hereby
agree as follows:
1.
As of the Effective Date, the following
portion of the worldwide rights and licenses granted to Cook and
the associated obligations of Cook under the Angiotech License
Agreement shall be terminated:
Cook’s worldwide right and license
to use, manufacture, have manufactured, distribute and sell, and to
grant sublicenses to its Affiliates to use, manufacture, have
manufactured, distribute and sell, the Angiotech Technology in the
Coronary Vascular Field of Use (as defined immediately below).
As used
herein, the “Coronary Vascular Field of Use” means
endoluminal vascular Licensed Applications for the treatment and\or
prevention of disease of the coronary arteries and their branches,
or other vasculature providing blood flow to the heart.
It is
acknowledged that under the Angiotech License Agreement, the
Licensed Field of Use and Licensed Applications do not include
vascular wrap applications or products for vascular
anastomoses.
-1-
The foregoing termination and foregoing
acknowledgment do not in any way terminate, expand, or diminish
Cook’s Licensed Field of Use under the Angiotech License
Agreement in Licensed Applications outside of the Coronary Vascular
Field of Use.
2.
As of the Effective Date, the following
portion of the worldwide rights and licenses granted to Cook and
the associated obligations of Cook under the Angiotech License
Agreement shall be extended in time as set forth in Paragraph 3
below:
Cook’s worldwide right and license
to use, manufacture, have manufactured, distribute and sell, and to
grant sublicenses to its Affiliates to use, manufacture, have
manufactured, distribute and sell, the Angiotech Technology in the
Peripheral Vascular Field of Use and the GI Field of Use (as they
are respectively defined immediately below).
As used herein, the “Peripheral
Vascular Field of Use” means [***] .
Notwithstanding the foregoing, “Peripheral Vascular
Field of Use” excludes any application in the Coronary
Vascular Field of Use. “GI Field of Use” means
[***] . For purpose of clarity, as a result of this
Amendment, Cook’s remaining Licensed Fields of Use under the
Angiotech License Agreement shall consist of Peripheral Vascular
and GI.
3.
As between Angiotech and Cook, Section
9.1(e) of the Angiotech License Agreement, as amended June 12,
2002, is replaced in its entirety with the following, pursuant to
which Angiotech hereby grants Cook an extension of time as to the
Peripheral Vascular Field of Use and the GI Field of Use
only:
9.1(e) Termination for Failure
to Commercialize Peripheral Vascular Field of Use .
Angiotech shall have the right, at its election, to terminate
any or all of Cook’s rights and licenses under the Angiotech
License Agreement in the Peripheral Vascular Field of Use (as
defined in this Amendment), if by [***] , none of Cook or
its Affiliates has completed the enrollment of all patients for a
pivotal clinical trial on an Eligible Peripheral Vascular Product
in the United States subject to an Investigational Device
Exemption, which trial is suitable for securing from the FDA final
approval to market and sell such Eligible Peripheral Vascular
Product in the United States. Any such termination will not
affect Cook’s rights and obligations in the GI Field of
Use.
Furthermore, as between Angiotech and
Cook, Section 9.1(g) of the Angiotech License Agreement, as amended
June 12, 2002, is replaced in its entirety with the
following:
9.1(g) Unanticipated Regulatory
Requirements in the Peripheral Vascular Field of Use .
Both parties acknowledge the necessity to meet all applicable
regulatory requirements in the major markets of the world (U.S.,
Europe, and Japan). Both parties also acknowledge the
uncertain regulatory requirements for a combination drug device
product. If regulatory requirements create significantly
longer timelines
-2-
than currently anticipated for Cook or
its Affiliates to receive regulatory approval for an Eligible
Peripheral Vascular Product (for instance, due to the requirements
of a separate and distinct dose finding trial in a major market of
the world), Cook or its Affiliates will notify Angiotech no later
than 30 days immediately following Cook’s or its
Affiliates’ first knowledge of any event that may give rise
to a longer than previously anticipated timeline for such
regulatory approval. Both parties shall then meet within 30
days of such notification to review the impact on timelines and to
negotiate in good faith an extension to the deadline set forth in
Section 9.1(e) above.
4.
As between Angiotech and Cook, Section
4.2(a) of the Angiotech License Agreement is replaced in its
entirety with the following:
4.2(a) Royalties on Eligible
Peripheral Vascular Products . “Eligible Peripheral
Vascular Products” means any Licensed Application in the
Peripheral Vascular Field of Use. Within sixty (60) days
after the end of each Contract Quarter during the term of the Cook
License, Cook shall pay Angiotech an additional royalty (the
“Cook Peripheral Vascular Royalty”) on Net Sales of
Eligible Peripheral Vascular Products that are covered in the
country of sale by one or more valid and enforceable claims
included in the Patent Rights, by Cook and its Affiliates during
such Contract Quarter in each of the Geographical Areas, calculated
as the sum of the royalties set forth in the following Sections
4.2(a)(i-iii), subject to Sections 4.2(a)(v-vii) below:
(i) with respect to sales during a
Contract Quarter of units of Eligible Peripheral Vascular Products
covered in the country of sale by one or more valid and enforceable
claims included in the Patent Rights from zero to the product of
the Peripheral Vascular Base Unit Number (Section 4.2(a)(iv)) for
such Eligible Peripheral Vascular Products for such Geographical
Area multiplied by [***] , the royalty shall be an
amount equal to [***] of the Net Sales of such units of
Eligible Peripheral Vascular Products;
(ii) with respect to sales during a
Contract Quarter of units of Eligible Peripheral Vascular Products
covered in the country of sale by one or more valid and enforceable
claims included in the Patent Rights from (x) the product of the
Peripheral Vascular Base Unit Number for such Eligible Peripheral
Vascular Products for such Geographical Area multiplied by
[***] , to (y) the product of the Peripheral Vascular Base
Unit Number of such Eligible Peripheral Vascular Products for such
Geographical Area multiplied by [***] , the royalty
shall be an amount equal to [***] of the Net Sales of such
units of Eligible Peripheral Vascular Products; and
(iii) with respect to sales during a
Contract Quarter of units of Eligible Peripheral Vascular Products
cover
