Exclusive License and Supply Agreement [Amendment] - ICN Pharmaceuticals Inc. and Schering-Plough Ltd.
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AMENDMENT TO EXCLUSIVE LICENSE AND SUPPLY AGREEMENT BETWEEN
ICN PHARMACEUTICALS. INC.
AND
SCHERING-PLOUGH LTD.
DATED JULY 28, 1995
This Amendment, effective as of the last date below, to the
Exclusive License and Supply Agreement between ICN Pharmaceuticals, Inc. ("ICN")
and Schering-Plough Ltd. ("Schering") dated July 28, 1995 (the "Agreement") is
entered into by and between the parties hereto with reference to the facts
below. Terms with initial capitals which are not specifically defined in this
Amendment shall have the defined meaning set forth in the Agreement.
WHEREAS, Section 3.2(c) of the Agreement provides for each
Party to file applications for Regulatory Approval and for Schering to provide
the required information necessary to allow ICN to file for Regulatory Approval
in the EU concurrently with Schering; and
WHEREAS, the parties wish to modify the Agreement to provide
for a more orderly process for Regulatory Approval in the EU; and
WHEREAS, the parties also wish to modify certain provisions of
the Agreement respecting the supply of product.
NOW, THEREFORE, in consideration of the foregoing premises and
the mutual covenants and obligations below, the Parties agree as follows:
1. Section 1.2 of the Agreement shall be modified by
inserting a replacement sentence as the first sentence of that section:
"1.2 "Cost of Goods" means the cost to ICN or
Schering, as the case may be, of Products
[REDACTED] as applicable."
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2. Section 3.2(c) of the Agreement shall be deleted in
its entirety and replaced with the following text:
"(c) In the EU, Schering shall be responsible for
filing applications for Regulatory Approval in the
name of each of the Parties. Schering shall be the
contact company for both applications, both at the
supra-national (e.g. EMEA) level and the local
country level. Schering shall have the responsibility
to manage the Regulatory Approval process for each of
the applications until all requisite approvals
necessary for successful commercialization, including
approval for pricing and third party reimbursement
approvals, are obtained. Neither Party shall
commercially enter the market until the other Party
has obtained substantially similar pricing and third
party (including applicable government) reimbursement
approvals, provided, however, that either Party shall
be permitted to enter the market if the other Party
chooses to delay market introduction for any other
reason."
3. Section 6.4(b) of the Agreement shall be modified by
inserting the following text after the second sentence of that section:
"Prior to commercial launch in any country of the
Territory, the Estimated Selling Price for that
country shall be set at an amount equal to
[REDACTED]."
4. Section 8.3(b) of the Agreement shall be modified by
inserting the following text after the first sentence of that section:
"However, unless otherwise specified in ICN's written
purchase requisition, Schering shall supply Product
to ICN in the form of capsules branded and blister
packed in cartons with ICN trade dress, labeled in
all EU languages and quality-control released in the
EU, such that Product so supplied will be suitable
for immediate sale to end users in the EU."
5. This Amendment to the Agreement is incorporated
therein and expressly made a part thereof.
6. This Amendment to the extent set forth herein,
amends, modifies and supplements the Agreement. Except as expressly modified
herein, all of the terms and provisions of the Agreement remain in full force
and effect and cannot be amended, modified or changed in any way whatsoever
except by a written instrument duly executed by the Parties hereto.
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IN WITNESS WHEREOF, the Parties have executed this Amendment
effective as of the last date below.
SCHERING-PLOUGH LTD. ICN PHARMACEUTICALS, INC.
By: /s/ David Poorvin By: /s/ David C. Waft
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David Poorvin David C. Waft
Title: Prokurist Title: Executive Vice President
General Counsel &
Corporate Secretary
Date: 10 December 1997 Date: 1/20/98
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