“[ * ]”
= omitted, confidential material, which material has been
separately filed with the Securities and Exchange Commission
pursuant to a request for confidential treatment.
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Exhibit 10.43
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Execution Copy
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RELEASE AND LICENSE
AGREEMENT
THIS RELEASE AND LICENSE AGREEMENT
(the “ Agreement ”) is made and entered into as
of October 22, 2008 (the “ Effective Date
”) by and between ZymoGenetics, Inc. having offices at
1201 Eastlake Avenue East, Seattle, WA 98102-3702 (“
ZymoGenetics ”), and
Bristol-Myers Squibb Company , a Delaware
corporation having offices at Route 206 & Province Line
Road, Princeton, NJ 08543 (“ BMS ”).
RECITALS
WHEREAS, BMS has
commercialized the drug product ORENCIA ® (abatacept) for therapeutic use
in humans;
WHEREAS, ZymoGenetics owns and
controls certain patent rights relating to fusion proteins,
including U.S. Patent Nos. 6,018,026 and 5,843,725;
WHEREAS, ZymoGenetics filed the
Pending Action against BMS in the United States District Court for
the District of Delaware, Case No. 06-500-SLR, alleging claims
relating to infringement of U.S. Patent Nos. 6,018,026 and
5,843,725;
WHEREAS, BMS denied infringing U.S.
Patent Nos. 6,018,026 and 5,843,725, and alleged U.S. Patent Nos.
6,018,026 and 5,843,725 were invalid; and
WHEREAS, ZymoGenetics and BMS desire
to enter into this Agreement as an amicable and final business
resolution to the Pending Action.
NOW, THEREFORE, in consideration of
the promises and the mutual covenants recited herein, the Parties
agree as follows.
ARTICLE 1
DEFINITIONS
The terms in this Agreement with
initial letters capitalized, whether used in the singular or the
plural, shall have the meaning set forth below or, if not listed
below, the meaning designated in places throughout this
Agreement.
1.1 “
Abatacept ” means the fusion protein known as
abatacept, and any pharmaceutical product containing such protein,
including the pharmaceutical product containing abatacept, which is
a fusion protein that consists of
[ * ] , being
sold by BMS under the trademark ORENCIA ® .
1.2 “ Affiliate ”
means any Person that (directly or indirectly) through one or more
intermediaries, controls, is controlled by, or is under common
control with the Party specified. For the purposes of this
definition, “control” shall mean the possession, direct
or indirect, of the power to cause the direction of the management
and policies of a Person, whether through ownership of fifty
percent (50%) or more of the voting securities of such Person,
by contract or otherwise.
1.3 “ Belatacept
” means the fusion protein known as belatacept (also known as
BMS-224818 and LEA29Y), which is a fusion protein that consists of
[ * ] , and
any pharmaceutical product containing such protein.
1.4 “ BMS Released
Parties ” and “ BMS Releasor ” means
BMS’ agents, servants, attorneys, employees, officers,
directors, Affiliates, predecessors, successors, assigns,
licensors, transferees (including but not limited to Sublicensees),
representatives and all persons and entities acting by, through,
under, or in concert with them or any of them.
1.5 “ Business Day
” means a day other than Saturday, Sunday or any day on which
commercial banks located in New York, New York are authorized or
obligated by applicable laws to close.
1.6 “ Controlled
” means, with respect to any patent, patent application or
other intellectual property rights, possession by ZymoGenetics or
any of its Affiliates of the right, whether directly or indirectly,
and whether by ownership, license or otherwise, to grant the
license, sublicense, release or covenant not to sue (as applicable)
to BMS as provided for in this Agreement without violating the
terms of any agreement in effect as of the Effective Date with any
Third Party.
1.7 “ Designee ”
means BMS collaborators or Sublicensees.
1.8 “ Dollar ” or
“ $ ” means the lawful currency of the United
States.
1.9 “ Effective Date
” shall have the meaning set forth in the preamble of this
Agreement.
1.10 “ Field ”
means the diagnosis, treatment, control or prevention of any human
disease, disorder or condition.
1.11 “ Licensed Patents
” means (a) U.S. Patent Nos. 6,018,026 and 5,843,725;
(b) any foreign counterpart of U.S. Patent Nos. 6,018,026
and/or 5,843,725; (c) any patent issuing anywhere in the world
from any application (including, but not limited to, divisionals,
continuations, continuations-in-part and renewals) claiming
priority (directly or indirectly) to U.S. Patent Nos. 6,018,026 or
5,843,725, or any patent or application from which U.S. Patent Nos.
6,018,026 or 5,843,725 claims priority; (d) any patents
anywhere in the world that are registrations, reissues, renewals,
reexaminations, confirmations, supplementary protection
certificates or extensions of any of clauses (a), (b) or (c);
and (e) any progeny of the foregoing.
1.12 “ Licensed Product
” means any pharmaceutical product or compound or biologic,
including but not limited to Abatacept and Belatacept.
1.13 “ Patents ”
means, to the extent Controlled by ZymoGenetics or any of its
Affiliates, any (a) patents and patent applications in any
country or jurisdiction Controlled by ZymoGenetics or any of its
Affiliates as of the Effective Date; (b) any patent issuing
anywhere in the world from any application (including, but not
limited to, divisionals, continuations, continuations-in-part and
renewals) claiming priority (indirectly or directly) to any of the
foregoing or claiming priority (indirectly or directly) to a patent
or patent application from which any of the foregoing claims
priority; (c) any patents anywhere in the world that are
registrations, reissues, renewals, reexaminations, confirmations,
supplementary protection certificates or extensions of any of
clauses (a) or (b); and (d) any application for any of
the foregoing.
[ * ]
Confidential Treatment Requested
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1.14 “ Party ”
means either ZymoGenetics or BMS. “ Parties ”
means collectively ZymoGenetics and BMS.
1.15 “ Pending Action
” means the action pending as of the Effective Date between
the Parties in the United States District Court for the District of
Delaware, Case No. 06-500-SLR (including Case
No. 06-500-SLR-MPT), relating to U.S. Patent Nos. 6,018,026
and 5,843,725.
1.16 “ Person ”
means any individual, firm, corporation, partnership, limited
liability company, trust, business trust, joint venture company,
governmental authority, association or other entity.
1.17 “ Released IP
” means (i) the Patents and (ii) any other
intellectual property rights Controlled by ZymoGenetics as of the
Effective Date.
1.18 “ Sublicensee
” means any Third Party which is licensed by BMS or any of
its Affiliates to make, have made, use, sell, have sold, offer for
sale, import and/or export Abatacept or Belatacept.
1.19 “ Territory
” means the entire world.
1.20 “ Third Party
” means any Person other than ZymoGenetics and its Affiliates
and BMS and its Affiliates.
1.21 “ ZymoGenetics
Releasors ” and “ ZymoGenetics Released
Parties ” means ZymoGenetics’ agents, servants,
attorneys, employees, officers, directors, Affiliates,
predecessors, successors, assigns, licensors, transferees,
representatives and all persons and entities acting by, through,
under, or in concert with them or any of them.
ARTICLE 2
LICENSE GRANT AND RELEASE
2.1 License . In
consideration of and subject to the terms and conditions of this
Agreement, ZymoGenetics hereby grants to BMS a fully paid-up,
royalty-free, perpetual, nonexclusive, worldwide license, with the
right to grant sublicenses to its Affiliates and Designees, under
the Licensed Patents to make, have made, use, sell, have sold,
offer for sale, import and/or export Licensed Product in the
Territory in the Field.
2.2 No Other License . Other
than the license granted in Section 2.1, no other license to
any other intellectual property of ZymoGenetics is granted herein.
For clarity, this Section 2.2 shall not limit
Section 2.3.
2.3 Release and Non-Assertion
.
(a) In consideration of and subject
to the terms and conditions of this Agreement, ZymoGenetics and
ZymoGenetics Releasors hereby forever release BMS and the BMS
Released Parties, from any and all claims, demands and rights of
action that ZymoGenetics and ZymoGenetics Releasors may have, now
or in the future, on account of any direct or indirect infringement
of the Licensed Patents. In consideration of and subject to the
terms and conditions of this Agreement, ZymoGenetics and
ZymoGenetics Releasors hereby forever release BMS and the BMS
Released Parties, from any and all intellectual property claims,
demands and rights of action that ZymoGenetics and
ZymoGenetics
[ * ]
Confidential Treatment Requested
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Releasors may have, now or in the future, based
on the Released IP, with respect to Abatacept and/or Belatacept,
including but not limited to any and all claims, demands and rights
of action that ZymoGenetics and ZymoGenetics Releasors may have,
now or in the future, on account of any direct or indirect
infringement of any Released IP as a result of the manufacture,
use, offer for sale, sale, importation and/or exportation of
Abatacept and/or Belatacept.
(b) ZymoGenetics and ZymoGenetics
Releasors covenant, subject to the terms and conditions of this
Agreement, not to either directly or indirectly make, file or
maintain any claim, demand, lawsuit, action or cause of action, of
whatever kind or character, now or in the future, in law or in
equity against BMS or any BMS Released Parties, jointly or
severally, which claim, demand, lawsuit, action or cause of action
asserts direct or indirect infringement of the Licensed Patents.
ZymoGenetics and ZymoGenetics Releasors covenant, subject to the
terms and conditions of this Agreement, not to either directly or
indirectly make, file or maintain any intellectual property claim,
demand, lawsuit, action or cause of action, of whatever kind or
character, now or in the future, in law or in equity, based on the
Released IP, with respect to Abatacept and/or Belatacept against
BMS or any BMS Released Parties, jointly or severally, including
but not limited to any claim, demand, lawsuit, action or cause of
action that asserts direct or indirect infringement of any Released
IP by the manufacture, use, offer for sale, sale, importation
and/or exportation of Abatacept and/or Belatacept.
(c) ZymoGenetics and ZymoGenetics
Releasors hereby forever release BMS and the BMS Released Parties
from any and all claims asserted in the Pending Action, and any and
all claims that could have been asserted in the Pending Action and
that are reasonably related to the issues to be decided in the
Pending Action.
2.4 Release by BMS . BMS and
the BMS Releasors hereby forever release ZymoGenetics and the
ZymoGenetics Released Parties from any and all claims asserted in
the Pending Action, and any and all claims that could have been
asserted in the Pending Action and that are reasonably related to
the issues to be decided in the Pending Action.
2.5 Covenant by BMS . BMS and
the BMS Releasors covenant, subject to the terms and conditions of
this Agreement, not to either directly or indirectly make, file or
maintain any claim, demand, lawsuit, action or cause of action, of
whatever kind or character, now or in the future, in law or in
equity challenging the validity or patentability or scope of the
Licensed Patents.
2.6 No Further Obligations .
ZymoGenetics is under no obligation to file, prosecute, defend or
maintain the Licensed Patents or the Released IP or to bring or
prosecute actions or suits against any Third Party for infringement
of any of the Licensed Patents or the Released IP.
2.7 Stipulation Of Dismissal
. ZymoGenetics and BMS shall, within five (5) Business Days of
ZymoGenetics’ receipt of payment pursuant to Article 3, cause
their respective counsel to execute and file in the Pending Action
a stipulation of dismissal of all claims and counterclaims with
prejudice, pursuant to Rule 41(a), Fed. R. Civ. P., in the form
attached hereto as Exhibit A . Each Party shall bear its own
costs and fees associated with the Pending Action and no request,
motion, petition or otherwise for such fees and/or costs shall be
made to the court.
ARTICLE 3
PAYMENTS
3.1 Payments . Within fifteen
(15) calendar days after the Effective Date, BMS shall pay to
ZymoGenetics a payment in the amount of twenty-one million Dollars
($21,000,000) in accordance
[ * ]
Confidential Treatment Requested
-4-
with Section 3.2. No other payments shall
be payable by BMS to ZymoGenetics under this Agreement in
consideration for the licenses, releases and rights granted by
ZymoGenetics to BMS under this Agreement.
3.2 Wire Transfer . Payment
under this Agreement shall be in Dollars, and unless notified by
ZymoGenetics in writing before payment is due, shall be made by
wire transfer pursuant to Section 3.1 to:
Bank of America
Acct:
[ * ]
ABA:
[ * ]
ARTICLE 4
REPRESENTATIONS, WARRANTIES, AND
DISCLAIMERS
4.1 Mutual Representations and
Warranties . Each Party represents and warrants to the other
Party that: (i) it has all requisite corporate power and
authority to enter into this Agreement and to perform its
obligations under this Agreement; (ii) execution of this
Agreement and the performance by such Party of its obligations
hereunder have been duly authorized; (iii) this Agreement is
legally binding and enforceable on each Party in accordance with
its terms; and (iv) the performance of this Agreement by it
does not create a breach or default under or conflict with any
other agreement or obligation to which it is a party, or violate
any applicable law, order, rule or regulation.
4.2 Representations and
Warranties of ZymoGenetics . ZymoGenetics represents and
warrants to BMS that:
(a) ZymoGenetics has the full right,
power, and corporate authority to enter into this Agreement and to
make the covenants and grant the licenses, releases and rights set
forth in this Agreement, and that this Agreement is enforceable
against it in accordance with its terms; and
(b) ZymoGenetics is owner of all
right, title and interest in and to the Licensed Patents and has
the full legal right, power and ability to grant the licenses,
releases and rights with respect to the Licensed Patents to BMS as
set forth in this Agreement; and
(c) ZymoGenetics is not as of the
Effective Date and will not thereafter become a party to any
agreement or other binding commitment or obligation of any kind,
the terms of which (i) conflict with the covenants and
obligations of ZymoGenetics (including the grant to BMS of the
licenses, releases and rights under Article 2) under this Agreement
or (ii) diminish limit or impair the ability of ZymoGenetics
to perform its covenants and obligations (including the grant to
BMS of the licenses, releases and right