[EXHIBIT 99.5.3]
AMENDMENT AND WAIVER
AMENDMENT AND WAIVER, dated as of December 1, 1998 (this
"Amendment"), to the International License Agreement, effective as of June
28, 1996 (the "Agreement") by and between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company, a
Delaware corporation ("▇▇▇▇▇▇-▇▇▇▇▇▇▇"), and Pfizer Inc., a Delaware
corporation ("Pfizer").
WHEREAS, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ has assigned certain of its rights and
obligations under the Agreement to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Export Limited, a
company organized and existing under the laws of Ireland ("Export"), in
accordance with an Assignment and Assumption Agreement dated as of
November 1, 1996;
WHEREAS, Pfizer has assigned certain of its rights and obligations
under the Agreement to Pfizer Overseas Inc., a corporation organized and
existing under the laws of Delaware ("Pfizer Overseas") in accordance with
an Assignment effective as of June 28, 1996;
WHEREAS, the Agreement has previously been amended by an Amendment
dated May 27, 1997 and an Amendment dated April 22, 1998; and
WHEREAS, upon this Amendment becoming effective, the parties have
agreed that certain provisions of the Agreement be amended in the manner
provided for in this Amendment;
NOW, THEREFORE, the parties hereto hereby agree as follows:
ARTICLE I - AMENDMENT AND WAIVER
SECTION 1.01. Amendment of Section 1.01. Section 1.01 of the
Agreement is hereby amended by adding the following new definitions
immediately before the definition of "Competing Products":
"China" means the People's Republic of China (excluding The Special
Administrative Region of Hong Kong and Macao)."
"China Exclusive Termination Date" shall mean the earlier of (i) the
date on which the Agreement is terminated with respect to China and Export
commences co-promoting the Products in China, in accordance with Section
2.01 of this Amendment or (ii) the termination or expiration of the
Agreement as it relates to China in accordance with the terms thereof.
SECTION 1.02. Waiver of Rights.
Notwithstanding that China is a Category 2 Country under the
Agreement, Export hereby agrees, for a period of five (5) years from the
Launch Date in China, to waive the rights of Export to sell Products in
China, as described in Section 2.01 (b) of the Agreement, and to
manufacture Products in China.
SECTION 1.03. General.
References to a "Section" or "Sections" herein shall mean the
relevant Section of this Amendment, unless otherwise noted as referring to
the relevant Section of the Agreement. Unless otherwise noted, capitalized
terms used herein shall have the meanings ascribed to them in the
Agreement. References herein to Export or Pfizer Overseas shall be deemed
to include their respective Affiliates, as appropriate.
ARTICLE II - ADDITIONAL AGREEMENTS
SECTION 2.01. Co-Promotion Election.
Without limiting Export's right to terminate the Agreement in
accordance with the terms thereof, Export shall have the right with
respect to China, at any time on or after the last day of Agreement Year
Five, to terminate the Agreement as it relates to China and to co-promote
the Products in China with PFIZER pursuant to the terms of the
International Co-Promotion Agreement, dated as of June 28, 1996 between
▇▇▇▇▇▇-▇▇▇▇▇▇▇ and PFIZER (the "International Co-Promotion Agreement"), as
amended by an Amendment dated the date hereof (the "International
Co-Promotion Amendment"), and assigned to Export. Export may exercise such
right by providing written notice to PFIZER at least six (6) months prior
to the date on which Export desires to commence co-promoting the Products,
which date shall not be earlier than the day after the last day of
Agreement Year Five for China, and this Agreement shall terminate on such
date.
SECTION 2.02. Agreement Year.
For the purposes of the Agreement as it relates to China, "Agreement
Years" means the period commencing on the Launch Date for China and ending
on the China Exclusive Termination Date.
SECTION 2.03. Post-Agreement Year One.
For the purposes of the Agreement as it relates to China, "Post-
Agreement Year One" means the twelve-month period commencing on the day
following the China Exclusive Termination Date; "Post-Agreement Year Two"
and "Post-Agreement Year Three" mean the successive twelve (12) month
periods thereafter.
SECTION 2.04. Term of Agreement.
For the purposes of the Agreement as it relates to China, "Term of
this Agreement" means the period from the date of the Agreement until the
China Exclusive Termination Date.
SECTION 2.05. Trademarks.
Notwithstanding the provisions of Section 2.03(e) of the Agreement,
in the event that Export elects, in accordance with Section 2.01 of this
Amendment, to co-promote the Products with PFIZER in China, PFIZER may
have the right to continue using the Trademark in China in accordance with
the International Co-Promotion Agreement, as amended by the International
Co- Promotion Amendment.
SECTION 2.06. Product Launch.
The provisions of Section 2.07 of the Agreement shall not apply with
respect to China.
SECTION 2.07. Regulatory Approvals.
Pfizer Overseas shall exercise reasonable efforts to obtain, as soon
as reasonably practicable (i) approval by the relevant Governmental or
Regulatory Authority of a Marketing Authorization for a Product which
includes labeling and Packaging (consistent with guidelines established by
the Operating Committee in accordance with the procedures set forth in
Section 4.01 of the International Co-Promotion Agreement), indications,
warnings, etc. materially equivalent to the provisions of Exhibit C of the
Agreement and a Price Approval, and such other licenses, consents and
authorizations as are required to initially import finished Product into
China, and to (ii) obtain the Manufacturing Authorization to Package the
Product in Dalian, China from bulk tablet form ("Bulk") supplied by
Export. Pfizer Overseas shall bear its own costs in obtaining such
Marketing Authorization, Price Approval and the Manufacturing
Authorization. Pfizer Overseas shall keep Export informed of negotiations
with Governmental or Regulatory Authorities in obtaining the Marketing
Authorization, Price Approval and the Manufacturing Authorization and
shall notify Export of the price it intends to accept for Price Approval
prior to finalization of such price all in accordance with the Agreement.
At the request of Pfizer Overseas, Export shall provide such reasonable
assistance as necessary in obtaining the foregoing approvals.
SECTION 2.08. License, Supply of Products, Bulk and Compliance with
Laws.
(a) Subject to Section 1.02 of this Amendment, during the Term of
this Agreement, Pfizer Overseas shall have, as provided in Section 2.01(b)
of the Agreement, an exclusive license under the Trademark and a semi-
exclusive license under the Patents and Technical Information to Package
the Products at its manufacturing facility in Dalian, China, and to use
and sell the Products in China. For purposes of this sub-clause, "semi-
exclusive" means to the exclusion of all other parties in China except
Export.
(b) Subject to the provisions of the Agreement, as amended, and until
the Manufacturing Authorization is issued by the Governmental or
Regulatory Authorities in China to Pfizer Overseas, Export shall supply
the Products to Pfizer Overseas, and Pfizer Overseas undertakes to
purchase the Products from Export to meet all of Pfizer Overseas's
requirements of Products for China. When the Manufacturing Authorization
is issued to Pfizer Overseas for the Products, Pfizer Overseas shall
procure the Bulk from Export and shall Package the Products all in
accordance with the Agreement and as specifically set forth in Article V
thereof.
(c) Pfizer Overseas shall Package the Products in accordance with (i)
the terms of the Agreement, (ii) acceptable pharmaceutical industry
practice and (iii) all applicable Laws and Good Manufacturing Practices.
(d) Pfizer Overseas shall refrain from infringing any patent of any
third party in connection with the Packaging of the Product.
(e) The parties agree to file with Governmental or Regulatory
Authorities in China a short form summary contract of the rights granted
by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to Pfizer Overseas to Package the Products in accordance
with this Amendment. The short form summary contract is intended solely
for ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Affiliates to file for and obtain administrative
protection under the Laws in China for the Product and such summary
contract shall not, in any manner whatsoever, be relied upon by either of
the parties to interpret their respective rights and obligations under
this Amendment, or the International License Agreement, the International
Co- Promotion Agreement or the International Collaboration Agreement, as
each has been amended.
SECTION 2.09. Quality Audit.
Without limiting the provisions of Section 5.04 of the Agreement,
Pfizer Overseas shall make that portion of its manufacturing facilities
where Products are Packaged, including all records and reference samples
related to Products, available for inspection by Export during business
hours. Records made available for inspection hereunder shall include
records relevant to assessing the quality of a Product in the event of a
complaint or a suspected defect.
SECTION 2.10. Regulatory Licenses, Approvals and Consents.
Without limiting the provisions of Section 5.06 of the Agreement,
Pfizer Overseas shall obtain all licenses, consents and authorizations of
applicable Governmental or Regulatory Authorities or third parties
necessary or desirable in connection with the Product and such Packaging
activities and shall comply in all material respects with all conditions
applicable to any such license, consent, permit or authority.
SECTION 2.11. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Payments.
In the event that Export elects, pursuant to Section 2.01 of this
Amendment, to terminate the Agreement with respect to China and to co-
promote the Products with Pfizer in China, Export shall make the payments
described in Section 7.02 of the Agreement based upon ten percent (10%) of
the average of Net Sales of Products in China generated in Agreement Year
Nine and Agreement Year Ten and not on the two (2) complete Agreement
Years immediately preceding the date of expiration or termination of the
Agreement. Such payments shall be made in addition to the amounts payable
pursuant to Section 2.21 of the International Co-Promotion Amendment.
Notwithstanding the terms of such Section 7.02, if Export exercises its
rights to co-promote under Section 2.01 of this Amendment, such payment
shall be payable by Export whether or not Export ceases the sale of
Products in China in any Post Agreement Year.
SECTION 2.12. Indemnification of Export.
With respect to activity in or affecting China, Pfizer Overseas and
Export shall each indemnify, defend and hold harmless the other as
provided in and subject to the terms of Sections 4.03 and 4.04 of the
International Collaboration Agreement dated June 28, 1996 between
▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Pfizer.
ARTICLE III - MISCELLANEOUS
SECTION 3.01. No Other Amendments; Confirmation. Except as expressly
amended, waived, modified and supplemented hereby, the provisions of the
Agreement are and shall remain in full force and effect.
SECTION 3.02. Governing Law. This Amendment shall be governed by and
construed in accordance with the law of the State of New York.
SECTION 3.03. Headings. The headings used in this Amendment have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
SECTION 3.04. Third Party Beneficiaries. None of the provisions of
this Amendment shall be for the benefit of or enforceable by any third
party, including, without limitation, any creditor of either party hereto.
No such third party shall obtain any right under any provision of this
Amendment or shall by reason of any such provision make any claim in
respect of any debt, liability or obligation (or otherwise) against either
party hereto.
IN WITNESS WHEREOF, the parties hereto, by their duly authorized
officers, have executed this Amendment as of the date first written above.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ PFIZER OVERSEAS INC.
EXPORT LIMITED
By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇ By: /s/ Mohand Sidi Said
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Name: ▇▇▇▇ ▇. ▇▇▇▇▇ Name: Mohand Sidi Said
Title: Managing Director Title: Vice President