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EXHIBIT 10.13.3
THIRD AMENDMENT TO COLLABORATION AGREEMENT
This Third
Amendment to Collaboration Agreement (this "Third Amendment")
dated as of December 21, 2005, is by and between Regeneron
Pharmaceuticals,
Inc., a corporation organized and existing under the laws of the
State of New
York and having its principal office at 777 Old Saw Mill River
Road, Tarrytown,
New York 10591 ("Regeneron ") and Aventis Pharmaceuticals Inc., a
corporation
organized and existing under the laws of the State of Delaware and
having a
principal place of business at 200 Crossing Blvd., Bridgewater, New
Jersey 08807
("Aventis").
INTRODUCTION
WHEREAS,
Regeneron and Aventis are Parties to a Collaboration Agreement,
having an effective date of September 5, 2003, as amended on
December 31, 2004,
and January 7, 2005 (the "Collaboration Agreement"); and
WHEREAS,
Regeneron and Aventis have determined that it is desirable to
amend certain provisions of the Collaboration Agreement to include
Japan in the
Territory under the terms and conditions set forth herein.
NOW,
THEREFORE, in consideration of the following mutual promises
and
obligations and for good and valuable consideration, the receipt
and sufficiency
of which are hereby acknowledged, the Parties, intending to be
legally bound,
hereby agree as follows:
Capitalized terms used in this Third Amendment and not defined
herein shall have
the meanings ascribed to them in the Collaboration Agreement.
1. ARTICLE
1. "DEFINITIONS". Article 1 of the Collaboration Agreement
shall
be amended
as follows:
(a)
Section 1.2 "Additional Major Market Country" shall be amended
by
adding the
words "Japan and" after the words "other than" and before the
words "the
Major Market Countries referred to in clause (i) of the
definition
thereof" therein.
(b)
Section 1.41 "Consolidated Net Profit/Loss Report" shall be amended
by
adding the
following sentence at the end thereof. "This report shall also
include,
in reasonable detail, Net Sales in Japan, ******* (as defined
in
Section
9.1(b)), and the Japan Royalty Payment in sufficient detail to
calculate
the Japan True-Up for such calendar quarter."
(c)
Section 1.53 "Develop" or "Development" shall be amended by adding
the
phrase "in
the case of all countries in the Territory except Japan," after
the
reference to "(c)" therein.
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(d)
Section 1.158 "Territory" shall be amended by deleting the
words
",
excluding Japan" therein.
2. SECTION
2.6 "JAPAN". Section 2.6 of the Collaboration Agreement shall
be
deleted in
its entirety.
3. SECTION
4.1 "LICENSE GRANTS". Section 4.1 of the Collaboration
Agreement
shall be
amended by deleting the reference to "(i)" therein and deleting
the phrase
"and (ii) the foregoing license grant shall not restrict or
prohibit
Regeneron's right to manufacture and supply Regeneron VEGF
Products
for importation into or use or sale in Japan."
4. SECTION
4.3 "SUBLICENSES; SUBCONTRACTING". Section 4.3 of the
Collaboration Agreement shall be amended by adding the phrase
"other than
Japan"
after the reference to the defined term "Rest of World Country"
in
clause (A)
therein.
5. SECTION
6.5 "VEGF PRODUCT PRICING AND PRICING APPROVALS". Section 6.5
of
the
Collaboration Agreement shall be amended by adding ", Japan"
immediately before the phrase "as well as the United States" in the
final
sentence
therein. Section 6.5 of the Collaboration Agreement shall be
further
amended by adding the words "or Japan" at the end thereof after
the reference to
"the United States."
6. SECTION
9.1(a) "SHARING OF COLLABORATION PROFITS AND LOSSES". Section
9.1(a) of
the Collaboration Agreement shall be amended by adding the
words
"other
than Japan" after the defined term "Rest of World Countries"
therein.
Section 9.1(a) shall be further amended by adding the following
sentence
at the end thereof: "In addition, in consideration of the
license
grants
herein for VEGF Products in Japan, and subject to the other
terms
and
conditions of this Agreement, Aventis shall pay to Regeneron as
part
of the
Quarterly True-Up a royalty on Net Sales in Japan calculated in
accordance
with the formula described in Schedule 1A (the 'Japan Royalty
Payment')."
7. SECTION
9.1(b) "SHARING OF COLLABORATION PROFITS AND LOSSES". Section
9.1(b) of
the Collaboration Agreement shall be amended by adding the
following
sentences at the end thereof: "Notwithstanding the foregoing,
Regeneron
and Aventis shall each be responsible for paying fifty percent
(50%) of
all *********** incurred in accordance with the terms of this
Agreement
and the applicable Co-Development Budget, subject to the terms
and
conditions set forth in Schedules 1 and 1A. As used herein, the
term
************ shall mean Development Costs incurred by the Parties
for JDC
approved
Clinical Trials conducted in Japan (and/or such other Asian
countries
as may be agreed upon by the Parties) in *********************
*******************************."
8. SECTION
9.2 "PERIODIC REPORTS". Section 9.2(c) of the Collaboration
Agreement
shall be amended by adding "Japan," after the words "in Major
Market
Countries," in clause (ii) therein. Section 9.2(c) of the
Collaboration Agreement shall be further amended by adding the
words "and
Japan"
after the phrase "with respect to the United States" in clause
(iii)
therein. Section 9.2(c) of the Collaboration Agreement shall be
further
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amended by
adding the words "and Japan" after the defined term "Major
Market
Countries" in clause (iv) therein.
9. SECTION
16.1(c) "CONFIDENTIAL PARTY INFORMATION". Section 16.1 of the
Collaboration Agreement shall be amended by deleting paragraph (c)
in its
entirety
and substituting the words "INTENTIONALLY BLANK" after the
reference
to "(c)" therein.
10. SECTION 17.1
"INDEMNITY AND INSURANCE". Section 17.1(a) of the
Collaboration Agreement shall be amended by adding a reference to a
"; or
" after
clause (ii) therein and inserting the following new clause
(iii):
"(iii)
notwithstanding anything to the contrary in this Agreement, the
Development or Commercialization of a VEGF Product in Japan under
this
Agreement,
except to the extent that Damages arise out of the negligence,
recklessness, bad faith or intentional wrongful acts, or
omissions
committed
by Regeneron or its Affiliates."
11. SCHEDULE I
"QUARTERLY TRUE-UP". Schedule 1 of the Collaboration Agreement
shall be
deleted in its entirety and replaced with Schedule 1 attached
to
this Third
Amendment, which is marked to reflect changes.
12. SCHEDULE 1A
"JAPAN TRUE-UP". The Collaboration Agreement shall be amended
by adding
a new Schedule 1A in the form attached to this Third Amendment.
13. UP-FRONT
PAYMENT. In consideration for Regeneron's agreement to enter
into
this Third
Amendment and extend the Territory to include Japan on the
terms set
forth herein, Aventis shall pay to Regeneron, on or before
January
10, 2006, a non-refundable, non-creditable payment of
Twenty-Five
Million US
Dollars (US$25,000,000.00) (which shall not be reduced by any
withholding or similar taxes).
14. SCHEDULE 2
"MILESTONE PAYMENTS". Schedule 2 of the Collaboration Agreement
shall be
amended by adding the milestones and milestone payments set
forth
in
Schedule 2 attached to this Third Amendment.
15. SCHEDULE
15.3(c) "JAPAN PATENT APPLICATIONS". Schedule 15.3(c) of the
Collaboration Agreement shall be amended by adding the Regeneron
Patent
Applications set forth in Schedule 15.3(c) attached to this
Third
Amendment.
16.
COMMERCIALIZATION. It is agreed that Regeneron shall not Co-Promote
VEGF
Products
in Japan. However, notwithstanding anything to the contrary in
the
Collaboration Agreement, the Parties shall establish a Joint
Country
Commercialization Sub-Committee in Japan, which shall have the
responsibilities set forth in Section 3.9(b). F
