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EXHIBIT 10.2
GLOBAL AMENDMENT TO MCP-1 AND IL-8 AGREEMENTS
Global Amendment to MCP-1 and IL-8 Agreements dated as of October __, 1997
(this "Global Amendment"), between LEUKOSITE, INC., a Delaware Corporation
("LeukoSite"), and XXXXXX-XXXXXXX COMPANY, a Delaware corporation ("Warner").
WHEREAS, LeukoSite and Warner are parties to the Research, Development
and Marketing Agreement, dated as of September 30, 1994, relating to MCP-1 (as
amended, the "MCP-1 Agreement");
WHEREAS, LeukoSite and Warner are parties to the Research, Development
and Marketing Agreement dated as of July 1, 1995, relating to IL-8 (as amended,
the "IL-8 Agreement"); and
WHEREAS, Warner desires that LeukoSite waive certain co-promotion rights
under the MCP-1 Agreement and IL-8 Agreement, and LeukoSite is willing to waive
such rights pursuant to the terms hereof.
NOW, THEREFORE, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 DEFINITIONS. Capitalized terms used in ARTICLE 2 but not defined
herein will have the meanings ascribed thereto in the MCP-1 Agreement.
Capitalized terms used in ARTICLE 3 but not defined herein will have the
meanings ascribed thereto in the IL-8 Agreement.
ARTICLE 2
MCP-1 AGREEMENT
2.1 SPECIFIC MCP-1 AMENDMENTS. The MCP-1 Agreement is hereby amended as
follows:
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Confidential Material Omitted and Filed
Separately with the Securities and Exchange Commission.
Asterisks Denotes Omissions
(a) SECTION 1.7. SECTION 1.7 of the MCP-1 Agreement is hereby
amended by adding the following to the end of such Section:
"Notwithstanding the foregoing, Warner may at any time undertake
research and/or development of MCP-1 inhibitors with Kyowa Hakko
Kogyo Co., Ltd., a Japan corporation ("Kyowa"), and its Affiliates."
(b) SECTION 4.1. The fifth, sixth and seventh sentences of SECTION
4.1 of the MCP-1 Agreement (beginning "Forty-five (45) days after
Warner provides...") are hereby deleted and replaced with the
following: "If Warner exercises marketing rights for a Development
Candidate within the stated period, the Development Candidate shall
become a "Warner Product". The parties acknowledge that although
many references to "Warner-LeukoSite Products" remain in the MCP-1
Agreement, the effect of this SECTION 2.1(b) is to remove the
possibility of a Development Candidate from becoming a
"Warner-LeukoSite Product" and, therefore, unless LeukoSite's
co-promotion rights are reinstated pursuant to SECTION 2.2 of this
Global Amendment such references have no effect.
(c) SECTION 5.3(a). SECTION 5.3(a) of the MCP-1 Agreement is hereby
amended by deleting the phrase "and/or" before the number "(iv)",
and inserting the following immediately before the end of such
Section: ", and/or (v) activities in connection with research,
development, marketing, sale and/or manufacture of compounds with
Kyowa and/or its Affiliates".
(d) SECTION 5.5(c). SECTION 5.5(c) of the MCP-1 Agreement is hereby
amended by adding the following immediately before the end of such
Section: ", and may also take into consideration Warner's
relationships with third parties (such as Kyowa)".
(e) SECTION 5.6(a). SECTION 5.6(a) of the MCP-1 Agreement is hereby
deleted in its entirety and replaced by the following: "For each
Warner Product, Warner will pay LeukoSite ***of worldwide, annual
Net Sales up to **********, *** of worldwide, annual Net Sales
above *********** and up to *********, and *** of worldwide,
annual Net Sales above ***********."
2.2 REINSTATEMENT OF CO-PROMOTION RIGHTS. Warner may at any time, in
its sole discretion, terminate SECTIONS 2.1(b) and 2.1(e) of this Global
Amendment by written notice to LeukoSite. In such event, LeukoSite will have 45
days to designate any Warner Product as a "Warner-LeukoSite Product" by written
notice to Warner. Thereafter, the parties will proceed as follows:
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(a) REMAIN A WARNER PRODUCT. If LeukoSite does not elect to convert
such Warner Product to a Warner-LeukoSite Product, LeukoSite and
Warner will estimate in good faith the designated share of
Development Costs that LeukoSite would have paid under SECTION 4.2
of the MCP-1 Agreement for the periods set forth in SUBSECTION
5.6(a)(i), (ii), or (iii) of the MCP-1 Agreement. Before the end of
the 45 day period, LeukoSite will pay Warner the Development Costs
referred to in SUBSECTION 5.6(a)(i), (ii), or (iii), and thereafter
LeukoSite will be entitled to receive the royalty rates referred to
in such Subsection. If Warner terminates SECTION 2.1(b) and 2.1(e)
of this Global Amendment prior to completion of all Phase II
clinical studies reasonably deemed necessary by the Management
Committee for regulatory approval to market the Product in the
United States of America, LeukoSite may elect to pay the designated
share of Development Costs that LeukoSite would have paid under
SECTION 4.2 of the MCP-1 Agreement up to and including the time that
Warner terminates such SECTION 2.1(b) and 2.1(e), and thereafter
LeukoSite may continue to pay its designated share of Development
Costs as they become due in order to preserve its rights to a
greater royalty under SECTION 5.6(a) of the MCP-1 Agreement.
(b) CONVERT TO A WARNER-LEUKOSITE PRODUCT. If LeukoSite does elect
to convert such Warner Product to a Warner-LeukoSite Product,
LeukoSite and Warner will estimate in good faith the designated
share of Development Costs that LeukoSite would have paid under
SECTION 4.2 of the MCP-1 Agreement up to and including the earlier
of (i) the time of such election and (ii) NDA approval in the United
States. Thereafter, if such election occurs prior to such NDA
approval, LeukoSite will continue to pay its designated share of
Development Costs as they become due up to and including such NDA
approval in order to keep such Warner-LeukoSite Product from
reverting to a Warner Product.
ARTICLE 3
IL-8 AGREEMENT
3.1 SPECIFIC IL-8 AMENDMENTS. The IL-8 Agreement is hereby amended as
follows:
(a) SECTION 1.7. SECTION 1.7 of the IL-8 Agreement is hereby
amended by adding the following to the end of such Section:
"Notwithstanding the foregoing, Warner may at any time undertake
research and/or development of IL-8 Inhibitors with Kyowa Hakko
Kogyo Co., Ltd., a Japan corporation ("Kyowa"), and its Affiliates."
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Confidential Material Omitted and Filed
Separately with the Securities and Exchange Commission.
Asterisks Denotes Omissions
(b) SECTION 4.1. The fifth, sixth and seventh sentences of SECTION
4.1 of the IL-8 Agreement (beginning "Forty-five (45) days after
Warner provides...") are hereby deleted and replaced with the
following: "If Warner exercises marketing rights for a Development
Candidate within the stated period, the Development Candidate shall
become a "Warner Product". The parties acknowledge that although
many references to "Warner-LeukoSite Products" remain in the IL-8
Agreement, the effect of this SECTION 3.1(b) is to remove the
possibility of a Development Candidate from becoming a
"Warner-LeukoSite Product" and, therefore, unless LeukoSite's
co-promotion rights are reinstated pursuant to SECTION 3.2 of this
Global Amendment such references have no effect.
(c) SECTION 5.3(a). SECTION 5.3(a) of the IL-8 Agreement is hereby
amended by deleting the Phrase "and/or" before the number "(iv)",
and inserting the following immediately before the end of such
Section: ", and/or (v) activities in connection with research,
development, marketing, sale and/or manufacture of compounds with
Kyowa and/or its Affiliates".
(d) SECTION 5.5(c). SECTION 5.5(c) of the IL-8 Agreement is hereby
amended by adding the following immediately before the end of such
Section: ", and may also take into consideration Warner's
relationships with third parties (such as Kyowa)".
(e) SECTION 5.6(a). SECTION 5.6(a) of the IL-8 Agreement is hereby
deleted in its entirety and replaced by the following: "For each
Warner Product, Warner will pay LeukoSite ** of worldwide, annual
Net Sales up to *********, *** of worldwide, annual Net Sales
above ********** and up to **********, and **** of worldwide,
annual Net Sales above *********."
3.2 REINSTATEMENT OF CO-PROMOTION RIGHTS. Warner may at any time, in
its sole discretion, terminate SECTIONS 3.1(b) and 3.1(e) of this Global
Amendment by written notice to LeukoSite. In such event, LeukoSite will have 45
days to designate any Warner Product as a "Warner-LeukoSite Product" by written
notice to Warner. Thereafter, the parties will proceed as follows:
(a) REMAIN A WARNER PRODUCT. If LeukoSite does not elect to convert
such Warner Product to a Warner-LeukoSite Product, LeukoSite and
Warner will estimate in good faith the designated share of
Development Costs that LeukoSite would have paid under SECTION 4.2
of the IL-8 Agreement for the periods set forth in SUBSECTION
5.6(a)(i), (ii), or (iii) of the IL-8 Agreement. Before the end of
the 45 day period, LeukoSite will pay Warner the Development Costs
referred to in SUBSECTION 5.6(a)(i), (ii), or (iii), and thereafter
LeukoSite will be entitled to receive the royalty rates referred to
in such Subsection. If Warner terminates SECTION 3.1(b) and 3.1(e)
of this Global Amendment prior to completion of all Phase II
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clinical studies reasonably deemed necessary by the Management
Committee for regulatory approval to market the Product in the
United States of America, LeukoSite may elect to pay the designated
share of Development Costs that LeukoSite would have paid under
SECTION 4.2 of the IL-8 Agreement up to and including the time that
Warner terminates such SECTIONS 3.1(b) and 3.1(e), and thereafter
LeukoSite may continue to pay its designated share of Development
Costs as they become due in order to preserve its rights to a great
royalty under SECTION 5.6(a) of the IL-8 Agreement.
(b) CONVERT TO WARNER-LEUKOSITE PRODUCT. If LeukoSite does elect to
convert such Warner Product to a Warner-LeukoSite Product, LeukoSite
and Warner will estimate in good faith the designated share of
Development Costs that LeukoSite would have paid under SECTION 4.2
of the IL-8 Agreement up to and including the earlier of (i) the
time of such election and (ii) NDA approval in the United States.
Thereafter, if such election occurs prior to such NDA approval,
LeukoSite will continue to pay its designated share of Development
Costs as they become due up to and including such NDA approval in
order to keep such Warner-LeukoSite Product from reverting to a
Warner Product.
ARTICLE 4
GOVERNING LAW
4.1 GOVERNING LAW. This Global Amendment shall be construed and
interpreted in accordance with the laws of the Commonwealth of Massachusetts,
other than those provisions governing conflicts of law.
ARTICLE 5
HEADINGS
5.1 HEADINGS. The headings appearing herein have been inserted solely
for the convenience of the parties hereto and shall not affect the construction,
meaning or interpretation of this Global Amendment or any of its terms and
conditions.
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ARTICLE 6
COUNTERPARTS
6.1 COUNTERPARTS. This Global Amendment may be executed in counterparts,
each of which shall be deemed an original and both of which together shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused this Global Amendment
to be signed by their duly authorized officers as of the date first above
written.
LEUKOSITE, INC. XXXXXX-XXXXXXX COMPANY
By: /s/ XXXXXXXXXXX X. XXXXXXXXX By: /s/ XXXXXXX XXXXXXXX
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Name: Xxxxxxxxxxx X. Xxxxxxxxx Name: Xxxxxxx Xxxxxxxx
Title: Title:
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