May 11, 1999
Via facsimile
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Kyowa Hakko Kogyo Co., Ltd.
Attn: Xxxxxx Goto, Licensing & Business Development
0-0-0 Xxxxxxxxx
Xxxxxxx-xx
Xxxxx 000-0000 XXXXX
Gentlemen:
Reference is made to that certain License Agreement between Cephalon, Inc.
("CEPHALON") and Kyowa Hakko Kogyo Co., Ltd. ("KYOWA") dated as of May 12, 1992,
as amended (the "License Agreement"), and further reference is made to that
certain Supply Agreement between CEPHALON and KYOWA dated as of August 1, 1994,
as amended (the "Supply Agreement"). All capitalized terms not otherwise
defined herein shall have the respective meanings ascribed to them in the
License Agreement and the Supply Agreement, as may be applicable.
Insofar as the parties now have determined that Cephalon is in a better
position to assume responsibility for the manufacture and supply of the
Substance(s), and insofar as Cephalon has agreed to assume the risk and
responsibility the parties hereby amend the License Agreement as follows:
1. The third sentence of Section 2.1 of the License Agreement relating to
the retention by KYOWA of all manufacturing rights is hereby deleted, and the
following terms are hereby added in lieu thereof: In connection with this grant
of right and license to CEPHALON, KYOWA hereby grants to CEPHALON the exclusive
right to manufacture the Substance(s) (except that KYOWA shall retain the right
to manufacture the Substance(s) for use and sale in those areas where KYOWA has
retained exclusive rights to commercialize the Pharmaceutical(s)). KYOWA hereby
further agrees to provide to CEPHALON certain Know-How relating to the
manufacture of the Substance(s) as may be necessary or advisable to facilitate
the efficient manufacture of the Substance(s) and further to provide additional
or updated Know-How from time to time to reflect developments (if any) in the
manufacturing process. KYOWA acknowledges that, in the course of engaging a
third party to serve as contract manufacturer of Substance(s), that CEPHALON
necessarily will disclose to such third party Know-How and other confidential
information. KYOWA hereby consents to such disclosure on the condition that any
such disclosure will be made pursuant to the terms of Article 9 of this License
Agreement, and further that CEPHALON will
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The emitted
portions have been filed separately with the Commission.
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require that any such third party agree to be bound by such terms. Moreover,
during the term hereof KYOWA hereby agrees to consult free of charge with
CEPHALON (and with a third party manufacturer to be designated by CEPHALON) with
respect to the KNOW HOW and to any technical issues relating to the
manufacturing of Substance(s).
2. Section 4.2 of the License Agreement is hereby deleted, and the
following terms are hereby inserted in substitution therefor: In consideration
of the rights granted to CEPHALON thereunder, CEPHALON shall pay KYOWA an amount
equal to [**] percent [**] of the Net Selling Price of the corresponding
Pharmaceutical(s) in the Territory. For purposes of clarification, the parties
acknowledge that this new provision shall be in lieu of the terms set forth in
Section E(1)(b) of the Supply Agreement and that the new supply agreement to be
negotiated and agreed upon by the parties shall not contain any similar
provision.
3. The entirety of Article 7 of the License Agreement relating to the
supply of Substance(s) by KYOWA is hereby deleted, and the following terms are
hereby inserted in substitution therefor: CEPHALON shall make available to
KYOWA Substance(s) on such terms and conditions as may be agreed upon by the
parties in a new supply agreement that will be substantially similar to those
set forth in the Supply Agreement (except as otherwise provided herein),
provided that KYOWA shall pay CEPHALON for the Substance(s) an amount equal to
CEPHALON's Cost of Manufacture. For purposes of clarification, the parties
acknowledge that KYOWA shall be responsible for transferring in a timely manner
Know-How relating to the manufacture and formulation of the Substance(s) to
CEPHALON or to a third party manufacturer to be designated by CEPHALON (with the
approval of KYOWA), but that following a period not to exceed one year from the
date of transfer of Know-How CEPHALON shall thereafter have sole responsibility
for managing the manufacturing process.
4. Furthermore, the parties hereby agree to terminate the Supply
Agreement, to be effective as of the effective date of a new supply agreement
between the parties reflecting the terms and conditions of this amendment as set
forth above.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The emitted
portions have been filed separately with the Commission.
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Please indicate your consent and agreement to the aforementioned terms by
signing a copy of this letter in the space provided below.
CEPHALON, INC.
By:__________________________
Xxxxx X. Xxxxxx, Ph.D.
Senior Vice President
Worldwide Business Development
KYOWA HAKKO KOGYO CO., LTD.
By:____________________________
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The emitted
portions have been filed separately with the Commission.
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