Waiver, Release and Option
Agreement for Taribavirin
This Waiver,
Release and Option Agreement for Taribavirin (the
“Agreement”) is entered into and made effective as of
the latest date of signature appearing below (the “Effective
Date”) by and between Valeant Pharmaceuticals International,
a Delaware corporation having offices located at One Enterprise,
Aliso Viejo, California 92656 (“Valeant”), Schering
Corporation, a New Jersey corporation having offices located at
2000 Galloping Hill Road, Kenilworth, New Jersey 07033
(“Schering”) and Schering-Plough Ltd., a Swiss
corporation having offices located at Weystrasse 20, 6000 Lucerne
6, Switzerland (together with Schering referred to herein as
“SP”). (Each of SP and Valeant is referred to from time
to time herein individually as a “Party” or
collectively as the “Parties”.)
WHEREAS, SP and
Valeant (as successor in interest to ICN Pharmaceuticals, Inc. and
RibaPharm, Inc.) are parties to that certain Agreement, dated
November 14, 2000, (the “November 2000
Agreement”) which grants SP certain rights of first and last
refusal with respect to certain products being developed by Valeant
and/or its Affiliates, and
WHEREAS,
Valeant is developing a proprietary product known as Taribavirin
(as defined below) and desires to grant exclusive licenses to
develop and commercialize Taribavirin to one or more independent
third parties, and
WHEREAS,
Valeant desires, and SP is willing to grant, a waiver and release
from all of SP’s rights of first and last refusal under the
November 2000 Agreement with respect to Taribavirin on the
terms and conditions set forth in this Agreement,
NOW, THEREFORE,
in consideration of the above and the mutual covenants set forth in
this Agreement and other valuable consideration the sufficiency of
which is hereby acknowledged by the Parties, the Parties agree as
follows:
1.
Definitions . All capitalized terms used in this Agreement
(whether in the singular or plural) shall have their respective
meanings as set forth herein, including without limitation the
following:
1.1
“Affiliate” shall mean, with respect to each
Party, any entity that directly or indirectly controls, is
controlled by, or is under common control with, such Party, where
control means the direct or indirect ownership of more than fifty
percent (50%) of the outstanding voting securities of an entity, or
such other relationship as results in actual control over the
management, assets, business and affairs of an entity.
1.2
“F&LR Rights” shall mean all of the rights,
options and other interests granted to SP and its Affiliates under
Sections 5.1 and 5.2 of the November 2000
Agreement.
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**
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CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
A CONFIDENTIAL TREATMENT REQUEST.
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1.3
“Japan License Agreement” shall have the meaning
set forth in Section 3 of this Agreement.
1.4
“Japan Option” shall have the meaning set forth
in Section 3 of this Agreement.
1.5
“Japan Option Term” shall mean the period
beginning on the Effective Date and ending on the earlier of:
(i) thirty (30) calendar days after [**]; or
(ii) the date on which Schering notifies Valeant that SP is
exercising the Japan Option.
1.6
“Taribavirin” shall mean the compound known as
taribavirin, any solvates (including without limitation hydrates),
acids, bases, esters, salts, isomers, stereoisomers, racemates,
enantiomers, tautomers, polymorphs and crystalline forms of any of
the forgoing. For the avoidance of doubt, [**] are excluded from
the definition of Taribavirin.
1.7
“Territory” shall mean all of the countries and
territories in the world except for Japan.
2. Waiver
and Release of Rights . SP (acting on behalf of itself, its
Affiliates and its and their successors in interest) hereby
expressly and irrevocably waives and releases all rights, options
and other interests held by SP and/or its Affiliates under the
November 2000 Agreement with respect to Taribavirin, including
without limitation the F&LR Rights as applied to Taribavirin.
The Parties acknowledge and agree that on and after the Effective
Date, and subject to Sections 3, 4 and 5 of this Agreement,
Valeant and its Affiliates shall be free to license or otherwise
dispose of any and all rights, title and interest with respect to
Taribavirin in the Territory without any further obligations to SP
and/or its Affiliates.
3. Japan
Option Rights . Valeant hereby grants to Schering the
irrevocable exclusive option during the Japan Option Term to obtain
an exclusive license to develop and commercialize Taribavirin
products in Japan (the “Japan Option”
).
4. Exercise
of Japan Option . Schering shall have the right, exercisable in
its sole discretion, to exercise the Japan Option rights at any
time during the Japan Option Term by providing Valeant with written
notice to that effect. Upon receipt of such notice, Valeant and
Schering (or its designated Affiliate) shall promptly negotiate and
enter into an exclusive license agreement for Taribavirin in Japan
(the “Japan License Agreement” ). The Japan
License Agreement shall expressly include the terms and conditions
set forth in Appendix 1 (attached to this Agreement) and such
other reasonable and customary terms and conditions (consistent
with Appendix 1) that are typical for such a license
agreement.
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**
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CERTAIN
INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
A CONFIDENTIAL TREATMENT REQUEST.
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2
5. Access to
Information . During the Japan Option Term, Valeant shall keep
Schering reasonably informed as to the status of development of
Taribavirin in the Territory by or on behalf of Valeant or its
third party licensees. Schering shall have the right, exercisable
at any time after [**] but prior to the expiration of the Japan
Option Term, to conduct a full due diligence review of any and all
data and information generated by or on behalf of Valeant and/or
any of its Affiliates, licensees or partners, in connection with
the development of Taribavirin products in the Territory. Upon
request by Schering, Valeant shall provide, and shall ensure that
its Affiliates, licensees and/or partners provide, Schering’s
employees, consultants and/or representatives with reasonable
access to such data and information as is necessary to enable
Schering to complete such due diligence review. Following
completion of such due diligence review, Valeant shall, upon
request during the remainder of the Japan Option Term, provide
Schering with (1) an update of any additional material
information related to the safety or efficacy of Taribavirin that
is generated, and (2) copies of any substantive communications
with the FDA or EMEA regarding an NDA or other application for
marketing authorization approval for Taribavirin in the
Territory.
6.
Confidentiality. Schering acknowledges and agrees that all
information and data received or otherwise made available to it
under Section 5 is confidential and proprietary information of
Valeant and/or its licensees or partners. Schering hereby
represents, warrants and covenants that Schering and its Affiliates
will use such information and data for the sole purpose of
evaluating its rights to exercise the Japan Option. Upon expiration
of the Japan Option Term, Schering shall upon request promptly
return to Valeant or, at the request of Valeant, destroy all
information and data received under Section 5. This section 6
shall survive the termination or expiration of the Japan Option
Term and the Term of this Agreement for any reason.
7.
Exclusivity Covenant . Valeant hereby represents, warrants
and covenants that during the Japan Option Term it shall not, and
shall ensure that its Affiliates do not, license, sell, transfer,
assign or convey to any third party or to otherwise encumber any
rights or interests in or to Taribavirin in Japan (including
without limitation (i) any related Japanese patents, patent
applications or trademarks, and (ii) any rights in Japan to
use trade secrets, data, know-how, information or other
intellectual property rights to Taribavirin and/or the manufacture
or use of Taribavirin) that are owned or controlled by Valeant
and/or its Affiliates. Valeant shall ensure that any licenses or
other rights or interests with respect to Taribavirin that it or
its Affiliates grants or conveys to any third party during the
Japan Option Term are consistent with the foregoing exclusivity
covenants, the rights granted to Schering under Sections 3, 4
and 5 of this Agreement, and the terms and conditions for the Japan
License Agreement that are set forth in Appendix 1.
8.
Publicity . Schering and Valeant shall agree on the form,
content and timing of any initial press releases concerning this
Agreement which the Parties intend to issue as soon as practicable
after the Effective Date. In the event that either Party intends to
issue any subsequent press release, public announcements or other
further public disclosures relating to this Agreement, the terms
and conditions hereof, and/or the performance by the Parties
hereunder, it shall provide the other Party with a copy of its
proposed release or public disclosure for review and
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