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CONFIDENTIAL TREATMENT EXHIBIT 10.15
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This Agreement is effective _____________________ , 1997 ("the
EFFECTIVE DATE") by and between Kyowa Hakko Kogyo Co. Ltd. (hereinafter referred
to as "KHK"), a corporation located at ▇-▇ ▇▇▇▇▇▇▇▇▇, ▇-▇▇▇▇▇, ▇▇▇▇▇▇▇-▇▇,
▇▇▇▇▇. ▇▇▇ ▇▇▇▇▇. and LeukoSite, Inc., a Delaware Corporation, located at ▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("LKS").
WHEREAS, KHK is a healthcare company which develops, manufactures, and
markets pharmaceutical products for human healthcare throughout the world; and
WHEREAS, LKS is the owner or exclusive licensee of certain technology
and other proprietary, know-how related to PRODUCTS as hereinafter defined; and
WHEREAS, KHK desires to obtain an exclusive right and license in and to
such technology and proprietary know-how in the TERRITORY as hereinafter
defined; and
WHEREAS, KHK desires to support additional research in the FIELD as
hereinafter defined to be conducted by LKS; and
WHEREAS, LKS is willing to grant the exclusive right and license
desired by KHK and to, conduct the research supported by KHK.
NOW, THEREFORE, in consideration of the mutual promises and other good
and valuable consideration, the parties agree as follows:
SECTION I - DEFINITIONS.
The terms used in this Agreement have the following meaning:
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1.1 The term "AFFILIATE" as applied to either party shall mean any
company or other legal entity other than the party in question in whatever
country organized, controlling controlled by or under common control with that
party. The term "control" means ownership or control, directly or indirectly, of
at least fifty percent (50%) of the outstanding stock, voting rights or the
right entitled to elect or appoint directors.
1.2 The term "AGREEMENT YEAR" shall mean the twelve month period
beginning on the EFFECTIVE DATE, and each subsequent twelve (12) month period
thereafter
1.3 The term "COMPOUND" shall mean individually and collectively a CCR1
COMPOUND and a CXCR3 COMPOUND.
1.4 The term "CCR1 COMPOUND" shall mean a small molecule which inhibits
or acts as an antagonist of the receptor CCR1.
1.5 The term "CXCR3 COMPOUND" shall mean a small molecule which
inhibits or acts as an antagonist of the receptor CXCR3
1.6 The term "DEVELOPMENT" shall mean the conduct of all preclinical,
chemical. chemical syntheses, formulations, assays and validation, testing and
development in accordance with Good Laboratory, Clinical and Manufacturing
Practices insofar as the same are reasonably necessary to obtain marketing
approval for a PRODUCT's first approved indication in any country and performed
by either party hereto in accordance with the DEVELOPMENT PLAN.
1.7 The term "DEVELOPMENT CANDIDATE" shall have the meaning set forth
in Section 5.9.
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1.8 The term "DEVELOPMENT PLAN" shall mean the written description of
DEVELOPMENT for each AGREEMENT YEAR of this Agreement provided in Section 5.8.
1.9 The term "DIAGNOSTIC PRODUCTS" shall have the meaning set forth in
Section 2.2(f).
1.10 The term "EXTENDED TERRITORY" shall mean the entire world other
than the KHK TERRITORY.
1.11 The term "FIELD" shall mean the treatment of diseases
in humans.
1.12 The term "FIRST COMMERCIAL SALE" shall mean in each country of the
TERRITORY, the first sale to a THIRD PARTY, in connection with the nationwide
introduction of any PRODUCT by KHK, its AFFILIATES or SUBLICENSEES following,
marketing and/or pricing approval by the appropriate governmental agency for the
country in which the sale is to be made and. when governmental approval is not
required, the first sale in that country in connection with the nationwide
introduction of a PRODUCT in that country.
1.13 The term "IND" shall mean an Investigational New Drug application
filed with the United States Food and Drug Administration ("FDA") or a
comparable application in other countries.
1.14 The term "JOINT PATENT RIGHTS" shall have the meaning set forth in
Section 5.15(b).
1.15 The term "KHK TERRITORY" shall mean Japan, Peoples Republic of
China, Korea, Taiwan, India, Singapore, Malaysia, Cambodia, Myanamar,
Philippines, Thailand, Laos, Indonesia, Vietnam and Pakistan.
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1.16 The term "KHK PATENTS" shall mean any United States patent
application, including any division, continuation, or continuation-in-part
thereof and any foreign patent application or equivalent corresponding, thereto
and any Letters Patent or the equivalent thereof issuing thereon or reissue,
re-examination or extension thereof. including KHK's interest in JOINT PATENT
RIGHTS which is owned by or licensed to KHK and in and to which KHK has a
transferable interest during the term of this Agreement insofar as it contains
one or more claims to KHK TECHNOLOGY.
1.17 The term "KHK TECHNOLOGY" shall mean information and materials,
including but not limited to, inventions, whether patentable or not,
pharmaceutical, chemical and biological products, technical and nontechnical
data and information relating to the results of tests, assays, methods, and
processes, and drawings, plans, diagrams and specifications and/or other
documents containing such information and data owned by KHK or to which KHK has
a transferable interest on the EFFECTIVE DATE and/or prior to termination of
this Agreement and which are necessary or useful for the manufacture, use or
sale of a PRODUCT.
1.18 The term "LKS PATENTS" shall mean any United States patent
application. including any division, continuation. or continuation-in-part
thereof and any foreign patent application or equivalent corresponding thereto
and any Letters Patent or the equivalent thereof issuing thereon or reissue,
re-examination or extension thereof, including LKS's interest in JOINT PATENT
RIGHTS which is owned by or licensed to LKS and in and to which LKS has a
transferable interest during the term of this Agreement insofar as it contains
one or more claims to LKS
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TECHNOLOGY. The LKS Patents in effect on the EFFECTIVE DATE are set forth in
Appendix A, attached hereto and made a part hereof.
1.19 The term "LKS TECHNOLOGY" shall mean information and materials,
including but not limited to, inventions, whether patentable or not,
pharmaceutical, chemical and biological products, technical and nontechnical
data and information relating to the results of tests, assays, methods, and
processes, and drawings, plans, diagrams and specifications and/or other
documents containing such information and data owned by LKS or to which LKS has
a transferable interest on the EFFECTIVE DATE and/or during the term of this
AGREEMENT and which are necessary or useful for the manufacture, use or sale of
a PRODUCT.
1.20 The term "NET SALES" means the gross amount invoiced by KHK or
LKS in the case of Sections 2.2(d) and 12.8, its AFFILIATES and SUBLICENSEES for
sale or distribution of PRODUCT to THIRD PARTIES, less cost of freight and
freight insurance, (if billed separately), returns, rebates, sales taxes. excise
taxes, duties and allowances actually paid, including cash and trade discounts,
provided, however, that a sale or transfer to an AFFILIATE for re-sale by such
AFFILIATE shall not be considered a sale for the purpose of this provision but
the resale by such AFFILIATE shall be a sale for such purposes. A "sale" shall
also include a transfer or other disposition for consideration, but not such
transfers or dispositions for preclinical, clinical, regulatory, or governmental
purposes prior to receiving marketing approval. In the event that consideration
in addition to or in lieu of money is received for PRODUCT, such consideration
shall be added to the NET SALES. To the extent that a PRODUCT is sold in other
than an arms length transaction. NET SALES
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shall be the fair market value of such PRODUCT if sold in an arms length
transaction. PRODUCT shall be considered "sold" at the earlier of (a) the
transfer of title in such PRODUCT to a person other than an AFFILIATE of such
party as aforesaid; or (b) the shipment of such PRODUCT from the manufacturing
or warehouse facilities of such party or its AFFILIATE to a customer.
1.21 The term "PATENT RIGHT(S)" shall mean individually and
collectively, KHK PATENTS, LKS PATENTS and JOINT PATENT RIGHTS.
1.22 The term "PRODUCT" shall mean any article, composition, material,
method, process or service in the FIELD which is or incorporates or utilizes a
COMPOUND.
1.23 The term "RESEARCH" shall mean the research performed by either
party in accordance with the RESEARCH PLAN, as amended from time to time by
agreement of the parties.
1.24 The term "RESEARCH PLAN" shall mean the written description of
RESEARCH for the first AGREEMENT YEAR and for each subsequent AGREEMENT YEAR of
the Research Collaboration as set forth in Appendix B attached hereto and made a
part hereof.
1.25 The term "RESEARCH TERM" shall mean the term of the Research
Collaboration as set forth in Section 5.13.
1.26 The term "SUBLICENSEE" shall mean any non-AFFILIATE THIRD PARTY
licensed by KHK to make. have made, import, use or sell any PRODUCT.
1.27 The term "TARGET" shall mean the chemokine receptor of CCR1 and/or
CXCR3.
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1.28 The term "TERRITORY" shall mean the KHK TERRITORY and the EXTENDED
TERRITORY.
1.29 The term "THIRD PARTY(IES)" shall mean a person or entity who or
which is neither a party hereto nor an AFFILIATE or SUBLICENSEE of a party
hereto.
1.30 The term "VALID CLAIM" shall mean (i) a claim of a pending patent
application or (ii) a claim of an issued patent which has not lapsed or become
abandoned or been declared invalid or unenforceable by a court of competent
Jurisdiction or an administrative agency from which no appeal can be or is
taken.
1.31 The term "WL" shall mean the ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Company.
1.32 The term "WL PATENT" shall mean any United States patent
application, including any division, continuation, or continuation-in-part
thereof and any Foreign patent application or equivalent corresponding thereto
and any Letters Patent or the equivalent thereof issuing thereon or reissue,
re-examination or extension thereof, including WL's interest in joint patent
rights, which JOINT PATENT RIGHTS are defined in Section 1. 14 and 5.15(b) and
which is owned by or licensed to WL and in and to which WL has a transferable
interest during the term of this Agreement insofar as it contains one or more
claims to WL TECHNOLOGY.
1.33 The term "WL TECHNOLOGY" shall mean information and materials,
including but not limited to, inventions, whether patentable or not.
pharmaceutical. chemical and biological products. technical and non- technical
data and information relating to the results of tests, assays, methods, and
processes, and drawings. plans, diagrams and specifications
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and/or other documents containing such information and data owned by WL or to
which WL has a transferable interest on the effective date of the Agreement
between WL and KHK and/or during the term of any sublicense agreement with KHK
and which are necessary or useful for the manufacture, use or sale of a PRODUCT.
1.34 The use herein of the plural shall include the singular, and the
use of the masculine shall include the feminine.
SECTION 2 - GRANT.
2.1 Unless this Agreement has already been terminated as set forth
herein, upon the selection by the parties of a COMPOUND for DEVELOPMENT under
Section 5.9, LKS shall grant to KHK and KHK shall accept from LKS an exclusive
royalty bearing right and license for the KHK TERRITORY under LKS' interest in
LKS TECHNOLOGY and LKS PATENTS to make, have made, use, sell, offer to sell or
import PRODUCTS containing the selected COMPOUND or COMPOUNDS in the
KHK TERRITORY but only for use in the KHK TERRITORY. At such time as KHK grants
a sublicense pursuant to Section 2.2(c) and for the duration of such sublicense,
the grant set forth herein shall also be applicable to the EXTENDED TERRITORY.
2.2 (a) Subject to Paragraph 2.2(b) KHK shall be entitled to extend the
license granted herein to AFFILIATES and to sublicense THIRD PARTIES but only
for the KHK TERRITORY.
In case of a license which has been extended to AFFILIATES or
sublicensed to a SUBLICENSEE, such AFFILIATES and SUBLICENSEES shall be bound by
all terms and conditions of this
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Agreement. KHK shall advise LKS of any such extension to AFFILIATES or
sublicenses to SUBLICENSEES and provide LKS with a copy of any sublicense within
sixty (60) days of execution of such sublicense.
(b) KHK shall guarantee and be responsible for the payment of all
royalties due and the making of reports under this Agreement by reason of sales
of any PRODUCTS by its AFFILIATES and SUBLICENSEES and their compliance with all
applicable terms of this Agreement. Performance or satisfaction of any
obligations of KHK under this Agreement by any of its AFFILIATES or SUBLICENSEES
shall be deemed performance or satisfaction of such obligations by KHK.
(c) The parties hereto acknowledge that KHK is negotiating with
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company ("WL") in order to sublicense to WL rights to develop
PRODUCTS in the TERRITORY in return for certain rights to KHK in such territory
already granted to WL by LKS. It is understood that any such agreement will
provide that WL will have six (6) months from the selection of a DEVELOPMENT
CANDIDATE by the parties hereto to obtain a sublicense under this Agreement. In
the event a sublicense is not granted within said six (6) month period, KHK's
rights to grant such sublicense in the EXTENDED TERRITORY shall terminate.
However, in the event such an agreement is executed between KHK and WL as
provided herein, the grant to KHK under Section 2.1 to KHK shall be applicable
to the EXTENDED TERRITORY in order to permit KHK to sublicense such rights to
WL, provided that if, at any time, such sublicense rights granted to WL
terminate, the rights granted to KHK under Section 2.1 shall thereafter be
limited to the KHK TERRITORY and
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all rights for the DEVELOPMENT of such PRODUCT in the EXTENDED TERRITORY shall
belong solely to LKS.
(d) During the term of this Agreement and during such time as LKS
retains rights with regard to PRODUCTS in the EXTENDED TERRITORY and subject to
Section 12.8, KHK will grant to LKS an exclusive sublicenseable, royalty-bearing
right and license for the EXTENDED TERRITORY under KHK PATENTS and KHK
TECHNOLOGY to make, have made, use, sell, offer to sell or import PRODUCTS for
use in the EXTENDED TERRITORY. The royalty shall be negotiated by the parties in
good faith but in no event shall such royalty be greater than * of NET SALES. In
addition, in the event KHK and WL do not enter into an agreement as set forth in
Section 2.2(c) or in the event such agreement terminates and in each case LKS
retains rights to PRODUCTS in the EXTENDED TERRITORY, the milestone payments
payable under Section 7.4 (ii), (iii) and (iv) shall be reduced by (*).
(e) For the avoidance of doubt, in the event of a sublicense by KHK to
WL, Section 2.1(a) and (b) shall be applicable to such sublicense and such
sublicense shall provide for a transfer of WL TECHNOLOGY and WL PATENTS to KHK
and/or LKS in the event of termination of such sublicense. In addition, the
sublicense shall provide that LKS shall be a third party beneficiary of such
sublicense and such sublicense shall terminate in the event this Agreement
terminates.
(f) LKS hereby grants to KHK an exclusive option during the RESEARCH
TERM to negotiate an agreement to research, develop, manufacture and sell
DIAGNOSTIC PRODUCTS (i.e., reagents in
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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combination with COMPOUNDS for the purpose of the diagnosis of disease in
humans). This option may be exercised at any time during the RESEARCH TERM on
written notice to LKS. Upon receipt of such notice, the parties will negotiate
for ninety (90) days thereafter, in good faith, the terms of such an agreement.
If the parties cannot reach an agreement within said ninety (90) days, neither
party will have any further obligation with respect to such DIAGNOSTIC PRODUCTS.
SECTION 3 - DUE DILIGENCE.
3.1 (a) KHK shall initiate and diligently use best efforts to develop
and register PRODUCTS and continue to use its best efforts to market and sell
PRODUCTS in the KHK TERRITORY and if licensed, also in the EXTENDED TERRITORY,
as the case may be.
(i) KHK shall provide written progress reports within fifteen
(15) days of the 1st of January of each calendar year (ending for each
particular PRODUCT with the FIRST COMMERCIAL SALE of that particular PRODUCT),
indicating efforts (including research and development manpower) and progress
toward achieving research tasks and DEVELOPMENT milestones described in the
RESEARCH and DEVELOPMENT PLANS.
(ii) Upon selection of a DEVELOPMENT CANDIDATE, the parties
shall agree that KHK shall meet the certain milestones including the following:
File an IND for one PRODUCT and Initiate Phase IIb/III Clinical Trials for one
PRODUCT with the timing for meeting such milestones to be agreed upon in the
DEVELOPMENT PLAN provided for in Section 5.8.
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(b) In the event that KHK falls to meet any of its obligations under
Section 3.1 (a) with respect to PRODUCT or advises LKS that it does not have a
significant interest in developing, marketing or selling a PRODUCT or does not
intend to develop, market or sell a PRODUCT, LKS shall have the right and option
to terminate this Agreement on sixty (60) days prior written notice.
(c) KHK shall provide written reports to LKS on June 30th and December
31st of each year concerning the efforts being made in accordance with this
Section with respect to PRODUCTS in each country of the TERRITORY. KHK shall
provide LKS with any additional information reasonably requested by LKS in this
respect.
(d) As part of KHK's obligations under this Section, KHK shall provide
to LKS, both prior to and after marketing PRODUCT, its marketing plans and sales
forecasts for each PRODUCT to be sold in the TERRITORY and/or the EXTENDED
TERRITORY, as the case may be.
3.2 LKS will use its best efforts to complete the RESEARCH pursuant to
the terms of Section 5.
3.3 To the extent LKS TECHNOLOGY and/or PATENT RIGHTS licensed to KHK
under this Agreement have been licensed by LKS from a THIRD PARTY under an
agreement with such party, ("Other Party Agreement(s)"), KHK understands and
agrees as follows:
(i) The rights licensed to KHK by LKS are subject to the
terms, limitations, restrictions and obligations of the Other Party
Agreement(s).
(ii) KHK will comply with the terms, obligations, limitations
and restrictions of the Other Party Agreement(s), except that
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the compensation terms set forth in this Agreement shall be the only
compensation payable to LKS by KHK hereunder.
SECTION 4 - CONFIDENTIALITY AND ADVERSE EXPERIENCES.
4.1 During the term of this Agreement, it is contemplated that each
party may disclose to the other, proprietary and confidential technology,
inventions. technical information, material, reagents, biological materials and
the like which are owned or controlled by the party providing such information
or which that party is obligated to maintain in confidence and which is
designated by the party providing such information as confidential
("Confidential Information"). Each party shall have the right to refuse to
accept the other party's Confidential Information. Each party agrees not to
disclose and to maintain the Confidential Information in strict confidence, to
cause all of its agents, representatives and employees to maintain the
disclosing party's Confidential Information in confidence and not to disclose
any such Confidential Information to a third party without the prior written
consent of the disclosing party and not to use such Confidential Information for
any purpose other than as licensed under this Agreement.
4.2 The obligations of confidentiality will not apply to information
which:
(i) was known to the receiving party or generally known to the
public prior to its disclosure hereunder through no fault of the disclosing
party or any agent, representative or employee thereof, or
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(ii) subsequently becomes known to the public by some means
other than a breach of this Agreement, including publication and/or laying open
to inspection of any patent applications or patents;
(iii) is subsequently disclosed to the receiving party by a
third party having a lawful right to make such disclosure and who is not under
an obligation of confidentiality to the disclosing party;
(iv) is required by law, rule, regulation or bona fide legal
process to be disclosed. provided that the disclosing party takes all reasonable
steps to restrict and maintain confidentiality of such disclosure and provides
reasonable notice to the non-disclosing party; or
(V) is approved for release by the parties.
4.3 The obligations of Section 4.1 notwithstanding, KHK or LKS, as the
case may be, may disclose the Confidential Information licensed hereunder. to
THIRD PARTIES who (i) need to know the same in order to secure regulatory
approval for the sale of PRODUCT, (ii) who need to know the same in order to
work towards the commercial development of PRODUCT, or (iii) who are approved by
LKS or KHK, as the case may be, provided that such parties are bound by
obligations of confidentiality and non-use at least as stringent as set forth
herein.
4.4 Each party will keep the other informed of all reports of Adverse
experiences ("AE's") coming to its knowledge and possibly related to PRODUCT.
All reports of AE's which are serious or unexpected shall be forwarded to the
other party immediately and/or in sufficient time to properly notify the
regulatory authorities.
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SECTION 5 - RESEARCH AND DEVELOPMENT COLLABORATION.
5.1 Object. As soon as practical after the EFFECTIVE DATE, a research
and development collaboration shall be established to discover and commercialize
COMPOUND(S) in the FIELD (the "Collaboration"). Each party agrees to conduct the
RESEARCH and DEVELOPMENT to be performed and KHK agrees to support and fund the
RESEARCH in accordance with the terms and conditions set forth below.
5.2 Oversight of the RESEARCH
(a) Oversight. The RESEARCH will be overseen and monitored by the
Committee described herein (the "Research Committee").
(b) Membership. Within ten (10) days of the EFFECTIVE DATE, LKS and KHK
shall each appoint three (3) persons (or such other number of persons as the
parties may determine) to serve on the Research Committee. Such representatives
will be qualified, by reason of background and experience. to assess the
scientific progress of the RESEARCH. Each party will have the right to change
its representation on the Research Committee upon written notice sent to the
other.
(c) Chair. The Research Committee will be chaired by one representative
of each party during each six (6) month period of the RESEARCH TERM. During the
first six (6) months the Research Committee will be chaired by a representative
of LKS.
(d) Responsibilities. The Research Committee will have authority to:
(i) review and approve the RESEARCH PLAN for each AGREEMENT
YEAR prepared by LKS;
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(ii) make recommendations regarding the performance and the
conduct of the RESEARCH pursuant thereto, and monitor performance thereunder:
(iii) modify the RESEARCH PLAN;
(iv) review any and all proposed publications or
communications relating to the Collaboration and the results therefrom. in
accordance with the procedure set forth in this Section 5;
(v) review any and all proposed filing or patent applications
in connection with the RESEARCH.
5.3 Meetings. The Research Committee will meet not less than two (2)
times a year during the RESEARCH TERM of the, at such dates, times and places as
agreed to by the parties. At such meetings, the Research Committee will discuss
the RESEARCH and the performance under the Collaboration, evaluate the results
thereof and set priorities therefor. All decisions made or actions taken by the
Research Committee will be made unanimously by its members with the LKS members
cumulatively having one vote and the KHK members cumulatively having one vote
each. The Committee will prepare written minutes of each meeting and a written
record of all decisions whether made at a formal meeting or not.
5.4 Committee Deadlock. If there are issues on which the Research
Committee cannot reach agreement because of a Deadlock (as hereinafter defined),
such matters will be submitted to the President and CEO of LKS and KHK. In the
event agreement cannot be reached at this level, the Deadlock shall be resolved,
in good faith, by KHK.
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For the purpose of this Section 5.4, "Deadlock" will mean, (i) with
respect to any matter considered and voted upon by the Research Committee, that
one party votes in favor of such matter and the other party does not vote in
favor of such matter or (ii) a quorum cannot be established for the Committee to
vote on a matter.
5.5 (a) Conduct of the Collaboration. RESEARCH and DEVELOPMENT will be
conducted at appropriate sites approved by the Research Committee.
(b) LKS will be responsible for conducting the biological (i.e.
molecular biology, cell biology, in vitro and in vivo pharmacology) and
chemistry (i.e. screening of LKS compound libraries, synthetic chemistry,
molecular modeling) research in the FIELD RESEARCH activities will also go on at
KHK. The nature of these activities [eg compound/natural product library
screening pharmacology, medicinal chemistry] and how and where they shall be
conducted shall be determined by the Research Committee and set forth in the
RESEARCH PLAN.
5.6 (a) Conduct of Development. LKS will, at no cost to LKS,
participate in DEVELOPMENT to the extent it desires to do so, provided however,
that the level of LKS' participation will be defined by the Development
Committee described below at the end of the research and discovery phase of the
COLLABORATION.
(b) KHK will be responsible for all preclinical and clinical
development costs both within the KHK TERRITORY and in the EXTENDED TERRITORY.
(c) KHK will have the right to assign (up to 2) KHK scientists at any
one time at LKS during the collaborative period. KHK will bear all
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costs related to such scientists, excluding indirect laboratory and overhead
costs.
5.7 Development Committee. Prior to the selection of a COMPOUND for
DEVELOPMENT, a Development Committee shall be established by the parties hereto.
The Development Committee shall be comprised of seven (7) persons, with four (4)
being appointed by KHK and the other three (3) being appointed by LKS. Such
member(s) of the Development Committee may be replaced by the party appointing
the member(s) with prior written notice to the other party. Any increase or
decrease in the number of the members of Development Committee shall be decided
by the Development Committee. All decisions of the Development Committee shall
require a majority vote of all of the members of the Development Committee. Once
established, the Development Committee will meet at least quarterly to evaluate
and discuss the Development of PRODUCTS. The chairperson of the Development
Committee will be appointed by KHK among the members of the Development
Committee.
5.8 Responsibility of the Development Committee. The purpose of the
Development Committee shall be to coordinate and expedite the DEVELOPMENT of
COMPOUNDS into commercially successful PRODUCTS in the TERRITORY. The parties
shall establish the DEVELOPMENT PLAN setting forth the strategy, schedule and
objectives for DEVELOPMENT of COMPOUNDS selected for the DEVELOPMENT of PRODUCTS
in the TERRITORY and submit the plan to the Development Committee. The
Development Committee shall review and revise the DEVELOPMENT strategy for such
PRODUCTS.
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The DEVELOPMENT PLAN shall be updated at least annually. KHK shall
keep the Committee regularly informed and consult with the Development Committee
no less frequently than quarterly with respect to KHK's clinical and regulatory
activity relative to PRODUCTS.
5.9 Selection of COMPOUNDS for DEVELOPMENT. As long as the Development
Committee is in existence, the Development Committee shall be responsible for
the selection of COMPOUNDS for development in the KHK TERRITORY which shall take
place upon a decision to proceed to GLP Technology and other safety/PK studies
required for submission of an IND or foreign equivalent ("DEVELOPMENT
CANDIDATE"). The Development Committee may select any COMPOUND for DEVELOPMENT
resulting from RESEARCH; provided however that such selection shall take place
no later than the end of the third AGREEMENT YEAR of the Agreement or all rights
granted herein and this Agreement shall terminate forthwith.
5.10 Financial Conditions.
(a) Support Commitment. Unless terminated prior to the end of the
RESEARCH TERM during the term of the Collaboration, KHK will provide funding to
LKS for RESEARCH in the amount of (i) * for the first AGREEMENT YEAR; (ii) * for
the second AGREEMENT YEAR (or * United States dollars * if two TARGETS are
pursued plus an agreed upon amount for the additional research which will be
necessary in such event) and (iii) * for the third AGREEMENT YEAR if KHK
determines to extend the RESEARCH TERM plus an
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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agreed upon amount for the additional research which will be necessary if two
(2) TARGETS are selected. The aforesaid funding will be inclusive of all costs
incurred by LKS implementing the RESEARCH PLAN at LKS.
(b) Payment Schedule. The support payments set forth above will be
payable by KHK annually in advance, with the First payment to be made on the
EFFECTIVE DATE hereof. However, * which the parties acknowledge has already been
received by LKS will be deducted from the aforesaid payment, therefore the
actual payment for the first AGREEMENT YEAR will be *.
(c) At the end of the First AGREEMENT YEAR KHK will pay LKS the second
payment of *(or *) if two TARGETS are selected and the agreed upon amount for
the additional research which will be necessary in such event) to support a
portion of RESEARCH at LKS in order to identify a small molecule compound for
development.
(d) At the end of the second AGREEMENT YEAR KHK shall make the *
payment for the third AGREEMENT YEAR plus an agreed upon amount for additional
research in the event two (2) TARGETS are selected in the event KHK agrees to
extend the RESEARCH TERM.
5.11 No Conflict With Research and Title to Equipment. LKS agrees that
the RESEARCH funds provided by KHK will be applied to the RESEARCH and may not,
without KHK prior written approval, be used in
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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support of any other research at LKS. LKS will retain title to any equipment
purchased with funds provided by KHK under this Agreement, if such purchase is
mutually agreed upon as part of the RESEARCH budget.
5.12 Reports, Records and Unexpended Research Funding.
(a) In the event LKS does not expend the amounts provided by KHK
pursuant to this Section 5 for RESEARCH for an AGREEMENT YEAR during the
RESEARCH TERM such amounts will be retained by LKS for use in a future AGREEMENT
YEAR or YEARS; provided that any amounts not expended by the end of the RESEARCH
TERM shall be repaid by LKS to KHK in the event the Agreement is terminated at
that time or credited against the milestone payment set forth in Section
7.2(iii); and provided further that the total amount to be credited under this
Section 5.12(a) shall not exceed a total of * for each of the two AGREEMENT
YEARS of the initial RESEARCH TERM.
(b) LKS shall provide and submit to KHK summary reports on a
semi-annual basis of the amounts expended for and a description of the work
performed in RESEARCH. The records on which such reports are based may be
reviewed no more than once each year, during normal business hours, by an
independent auditor selected by KHK and reasonably acceptable to LKS. All
information disclosed in such a review shall be deemed Confidential Information
of LKS.
5.13 Term and termination of the Research Collaboration.
The term of the Research Collaboration will be two (2) years from the
EFFECTIVE DATE hereof unless extended by mutual agreement.
*Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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Either party may request an extension of up to one (1) year under terms set
forth herein.
(a) The initial stage ("Stage I") of the RESEARCH will have a term of
one year. At the end of one year, KHK will have the option to (i) select a
target either CCRI or CXCR3 for the second stage of RESEARCH ("Stage 2") and
terminate its rights to obtain a license and this Agreement with respect to the
TARGET which it has not selected, (ii) select both TARGETS or (iii) terminate
this Agreement. In the event KHK elects to continue the RESEARCH into Stage 2
the parties will work together during the next AGREEMENT YEAR or any mutually
agreed upon AGREEMENT YEARS to identify COMPOUND(S) for DEVELOPMENT KHK will
have the right to terminate Stage 2 of the RESEARCH at the end of each AGREEMENT
YEAR on prior written notice, as provided in Section 12.8.
(b) KHK shall be entitled to terminate the RESEARCH and cease funding
thereof in the event of a material breach by LKS of any of LKS's obligations and
covenants hereunder following written notice of such breach to LKS. If such
breach is not cured within thirty (3O) days after written notice is given by KHK
to LKS specifying the breach, KHK may terminate the RESEARCH and cease funding
hereunder forthwith upon written notice to LKS after expiration of such thirty
(30) day period, in which case KHK will not be responsible for any actual and
noncancelable expenditures of LKS unpaid to the date of termination and the
remedies set forth in this paragraph shall be KHK's sole and exclusive remedies
for such breach under this Agreement.
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(c) In the event that the RESEARCH is terminated pursuant to Section
5.13(b), LKS's right to receive any unpaid balance otherwise committed by KHK as
support commitment hereunder will become forfeited and no further payments with
respect to the RESEARCH will be due to LKS by KHK except to the extent that such
funds are necessary to pay actual and non-cancelable obligations of LKS accrued
to that date.
(d) LKS may terminate RESEARCH and/or DEVELOPMENT for breach by KHK of
its obligations hereunder in which case this Agreement and all licenses and
rights granted herein shall terminate forthwith.
5.14 Confidentiality. In order to facilitate the operation of RESEARCH
and/or DEVELOPMENT either party may disclose confidential or proprietary
information owned or controlled by it to the. other. It is hereby understood and
agreed that such information shall be deemed "Proprietary Information" and
treated as such in accordance with Section 4 hereof.
5.1 5 Results of the Research Collaboration.
(a) All right, title and interest in and to any new or useful process,
manufacture, compound or composition of matter, materials, Information, data,
inventions and know-how, patentable or unpatentable, or any improvement thereof,
conceived or first reduced to practice, or demonstrated to have utility during
the conduct of the Collaboration (the "Results"), and any patent applications or
patents based thereon, solely by employees or others acting on behalf of LKS
shall be owned solely by LKS ("LKS Results"), and solely by employees or others
acting on behalf of KHK shall be owned solely by KHK ("KHK Results").
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(b) The Parties recognize that, as a result of the Collaboration
between KHK and LKS hereunder, certain Results may be deemed to be joint
inventions, in accordance with applicable law, as both:
(i) one or more employees or agents of LKS or any other
persons obliged to assign such Results to LKS, and
(ii) one or more employees or agents of KHK or any other
persons obliged to assign such Results to KHK, are joint inventors of such
Results ("Joint Results"). In that event, the Parties shall jointly own patents,
inventor's certificates and applications therefor covering such Joint Results
("JOINT PATENT RIGHTS").
(c) To the extent that any LKS Results or Joint Results are necessary
to make, have made, use or sell PRODUCTS, LKS' interest in such Results shall be
included in PATENT RIGHTS licensed to KHK in the TERRITORY or EXTENDED
TERRITORY, as the case may be, under this Agreement. To the extent that any KHK
Results or Joint Results are necessary to make, use or sell PRODUCTS. KHK's
interest in such Results as well as KHK PATENTS and KHK TECHNOLOGY shall be
exclusively licensed to LKS in the EXTENDED TERRITORY to the extent LKS retains
rights in such TERRITORY under this Agreement.
(d) Any Result that a party believes may involve a patentable invention
or a preliminary finding of scientific significance will be promptly disclosed
to the Other Party at the earliest practicable time.
(e) There will be no publication of the Results by LKS or KHK, or any
LKS or KHK employee unless the Research Committee has reviewed the proposed
scientific publication concerning the Results. A party will, upon request by the
other party, delay publication to enable patent rights
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to be perfected, but in no event shall such delay exceed sixty (60) days from
the time the publication was submitted to the receiving party.
SECTION 6 - PATENTS.
6.1 (a) Each party shall promptly advise the other party in writing of
each invention arising from the Collaboration. Representatives of LKS and KHK
shall then discuss whether a patent application or applications pertaining to
such invention should be filed and in which countries. The titles, serial
numbers and other identifying data of patent applications claiming an invention
to which KHK is granted rights hereunder and filed after the EFFECTIVE DATE by
mutual agreement of LKS and KHK, shall be listed in Appendix A and shall become
LKS PATENTS.
(b) LKS at its cost and expense shall file, prosecute and maintain LKS
PATENTS through patent counsel selected by LKS, who shall consult with and keep
KHK advised with respect thereto. provided that the costs and expenses paid by
LKS for LKS PATENTS conceived or reduced to practice after the EFFECTIVE DATE
will be included as part of the support commitment set forth in Section 5.10 and
paid out of such funding.
(c) After the EFFECTIVE DATE, all costs and expenses incurred under
this Section with respect to JOINT PATENT RIGHTS and KHK PATENTS will be paid by
KHK.
(d) Included in patent costs are all reasonable costs for the
prosecution, issuance, and maintenance of such applications and patents issuing
thereon, and any divisional, continuation-in-part, reissue
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applications or patents, patents-in-addition, patents-of-revalidation or the
registrations of any patent or the like.
(e) Notwithstanding anything in this Section, KHK may, at its
discretion, elect to discontinue financial support of any patent or patent
application, provided, however, that prior to taking such action, KHK will
notify LKS of its intention at least ninety (90) days prior to the date on which
any payment or action is due. In any country in which KHK has elected to
discontinue its support of any patent application or patent. LKS, upon receiving
notice, may elect at its own expense to assume all financial responsibility for
the prosecution or maintenance of such patent application or patent. In such
event the license of the patent or patent application will be deemed to have
expired with respect to that country upon LKS's receiving notice of KHK's
decision. If any such patent or patent application is based upon a Joint Result,
then KHK shall promptly thereafter assign all of its rights and interest in any
such patent or patent application to LKS without further cost or obligation of
LKS to KHK.
6.2 With respect to any PATENT RIGHTS, each patent application, office
action, response to office action, request for terminal disclaimer, and request
for reissue or reexamination of any patent issuing from any such application
shall be provided to the other party sufficiently prior to the Filing of such
application, response or request to allow for review and comment by such party.
The owner of the patent application or patent shall have the right to take any
action that in its judgment is necessary to preserve such rights.
6.3 (a) If any of the PATENT RIGHTS under which KHK is licensed
hereunder is infringed by a THIRD PARTY in the TERRITORY,
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KHK shall have the right and option but not the obligation to bring an action
for infringement, at its sole expense, against such third party in the name of
LKS and/or in the name of KHK, and to LKS as a party plaintiff if required. KHK
shall promptly notify LKS of any such infringement and shall keep LKS informed
as to the prosecution of any action for such infringement. No settlement,
consent or other voluntary final disposition of the suit which adversely affects
LKS PATENTS may be entered into without the consent of LKS, which consent shall
not unreasonably be withheld.
(b) In the event that KHK shall undertake the enforcement and/or
defense of the PATENT RIGHTS under which KHK is licensed hereunder by litigation
any recovery of damages by KHK for any such suit shall be applied first in
satisfaction of any unreimbursed expenses and legal fees of KHK relating to the
suit. The balance remaining from any such recovery shall be divided equally
between KHK and LKS.
(c) In the event that KHK elects not to pursue an action for
infringement, upon written notice to LKS by KHK that an unlicensed THIRD PARTY
is an infringer of a VALID CLAIM of PATENT RIGHTS licensed to KHK, LKS shall
have the right and option, but not the obligation at its cost and expense to
initiate infringement litigation and to retain any recovered damages.
(d) In any infringement suit either party may institute to enforce the
PATENT RIGHTS pursuant to this Agreement, the other party hereto shall, at the
request of the party initiating such suit, cooperate in all respects and. to the
extent possible, have its employees testify when requested and make available
relevant records, papers, information,
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samples, specimens, and the like. All reasonable out-of-pocket costs incurred in
connection with rendering cooperation requested hereunder shall be paid by the
party requesting cooperation.
SECTION 7 - ROYALTIES AND OTHER COMPENSATION.
7.1 (a) KHK shall pay to LKS royalties on the annual NET SALES of
PRODUCTS sold by KHK, its AFFILIATES and SUBLICENSEES in the TERRITORY as
follows: * of NET SALES up to *, * of NET SALES over * and less than * and
* of NET SALES * or over.
(b) Such royalties shall be paid as set forth above by KHK, on a
country by country, PRODUCT by PRODUCT, basis for a period of at least twelve
(12) years in each country of the TERRITORY from the date of FIRST COMMERCIAL
SALE by KHK, its AFFILIATES and SUBLICENSEES of such PRODUCT in each such
country and thereafter such PRODUCT is covered by a VALID CLAIM of a PATENT
RIGHT, such royalties shall be payable until the last to expire PATENT RIGHT in
such country.
7.2 (a) Subject to Section 2.2(d), KHK shall pay the following amounts
upon the occurrence of the following milestone events, which may be achieved by
KHK through a SUBLICENSEE or AFFILIATE.
(i) * upon selection of a DEVELOPMENT CANDIDATE as set forth in the
Agreement. In addition, in the event KHK elects to pursue two (2) TARGETS with
LKS, KHK will pay to LKS *
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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* upon selection of the first DEVELOPMENT CANDIDATE resulting from the second
TARGET chemokine receptor program.
(ii) * upon initiation of human clinical trials of a COMPOUND
(from each chemokine receptor TARGET program).
(iii) * upon initiation of Phase III clinical trials of a
COMPOUND (from each chemokine receptor TARGET program).
(iv) * upon issue of first market approval of a COMPOUND (from
each chemokine receptor TARGET program)
(b) Should a COMPOUND and/or PRODUCT replace another compound and/or
PRODUCT before such compound and/or PRODUCT reaches the market, it shall, for
the purpose of milestones, enter at the next payable milestone.
7.3(a) In the event that royalties are required to be paid by KHK to a
THIRD PARTY who is not an AFFILIATE of KHK in order for KHK to make, use and
sell PRODUCT without infringing such THIRD PARTY'S patents and for which
royalties are also due to LKS pursuant to Paragraph 7.1 (such royalties to such
THIRD PARTY are hereinafter "Other Royalties"), then the royalties to be paid to
LKS by KHK pursuant to Paragraph 7.1 shall be reduced by one-half of the amount
of such Other Royalties. but in no event shall any royalties payable under
Paragraph 7.1 be reduced by more than * of NET SALES. As an example, if the
royalty due LKS is * and Other Royalties
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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are *, then the royalties due LKS may be reduced, but only by * to * of
NET SALES.
(b) In the event that litigation against KHK is initiated by a
THIRD-PARTY charging KHK with infringement of a patent of the THIRD PARTY as a
result of the manufacture, use or sale by KHK of PRODUCT covered by a PATENT
RIGHT licensed hereunder KHK shall promptly notify LKS in writing. * of KHK's
costs as to any such defense shall be creditable against any and all payments
due and payable to LKS under Section 7.1 of this Agreement but, subject to
Section 7.3(a), no royalty payment after taking into consideration any such
credit under this Section 7. (b) shall be reduced by more than * as set forth in
Section 7 3(a).
7.4 KHK shall keep, and shall cause each of its AFFILIATES and
SUBLICENSEES to keep. full and accurate books of account containing all
particulars relevant to its sales of PRODUCTS that may be necessary for the
purpose of calculating all royalties payable to LKS. Such books of account shall
be kept at their principal place of business and, with all necessary supporting
data shall, for the five (5) years next following the end of the calendar year
to which each shall pertain, be open for inspection by an independent certified
public accountant reasonably acceptable to KHK, upon reasonable notice during
normal business hours at LKS's expense for the sole purpose of verifying royalty
statements or compliance with this Agreement. In the event the inspection
determines that royalties due LKS for any period have been underpaid by five
percent (5%) or more, then KHK shall pay for all costs of the inspection. In all
cases, KHK shall pay to LKS any underpaid royalties promptly and with
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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interest at the prime rate available to LKS, plus two percent (2%). All
information and data reviewed in the inspection shall be used only for the
purpose of verifying royalties and shall be treated as KHK Confidential
Information subject to the obligations of this Agreement. No audit by an agent
of LKS shall occur more frequently than once during any twelve (12) month
period.
7.5 In each year the amount of royalty due shall be calculated
quarterly as of the end of each CALENDAR QUARTER (each as being the last day of
an "ACCOUNTING PERIOD") and shall be paid quarterly within the thirty (30) days
next following such date. Every such payment shall be supported by the
accounting prescribed in Paragraph 7.6 and shall be made in United States
currency. Whenever for the purpose of calculating royalties, conversion from any
foreign currency shall be required. such conversion shall be at the rate of
exchange published in The Wall Street Journal for the last business day of the
ACCOUNTING PERIOD.
7.6 With each quarterly payment, KHK shall deliver to LKS a full and
accurate accounting to include at least the following information:
(a) Quantity of PRODUCT subject to royalty sold (by
country) by KHK, its AFFILIATES and SUBLICENSEES,
(b) Total receipts for each PRODUCT subject to royalty
(by country);
(C) Total royalties payable to LKS
7.7 Royalties payable to LKS which are subject to withholding tax will
be paid net of any amounts to be withheld by KHK in accordance
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with applicable withholding provisions of the tax laws of Japan. All other
payments due hereunder, except the payment provided for in Section 7.2(a)(iv)
will be paid in full to LKS with no deduction for withholding taxes.
SECTION 8 - REPRESENTATIONS AND WARRANTIES.
8.1 Each party represents and warrants to the other party that: (i) it
is free to enter into this Agreement; (ii) in so doing, it will not violate any
other agreement to which it is a party; and (iii) it has taken all corporate
action necessary to authorize the execution and delivery of this Agreement and
the performance of its obligations under this Agreement.
8.2 LKS hereby represents and warrants to KHK that:
(a) It is the owner of, or is the licensee of the proprietary
information related to PRODUCTS which it has provided to KHK under this
Agreement, and accordingly has the right to grant licenses or sublicenses
therefor;
(b) As of the EFFECTIVE DATE, all patent applications included in LKS
PATENTS are pending and have not been abandoned;
(c) It has not entered into any agreement with any THIRD PARTY which is
in conflict with the rights granted to KHK pursuant to this Agreement;
(d) To the best of its knowledge as of the EFFECTIVE DATE there are no
claims or demands which it believes can be enforced against any PRODUCTS
disclosed in the LKS PATENTS in effect on the EFFECTIVE DATE;
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(e) To the best of its knowledge and without having made any special
investigation for this purpose, the practice of any process or PRODUCT disclosed
in the LKS PATENTS in effect on the EFFECTIVE DATE does not infringe upon any
THIRD PARTY patents.
8.3 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT LKS MAKES
NO REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR VALIDITY OF ANY LKS PATENT OR
OTHER INTELLECTUAL PROPERTY RIGHTS.
SECTION 9 - INDEMNIFICATION AND INSURANCE.
9.1 Indemnification by KHK
KHK will defend, indemnify and hold harmless LKS, its AFFILIATES and
licensors and their employees, agents, officers, trustees. shareholders and
directors and each of them (the "LKS Indemnified Parties") from and against any
and all third party claims, causes of action and costs (including reasonable
attorney's fees) of any nature made or lawsuits or other proceedings filed or
otherwise instituted against the LKS Indemnified Parties resulting from or
arising out of this Agreement or out of the research, development, testing,
manufacture, sale or use of any PRODUCT by KHK or its AFFILIATES or its
SUBLICENSEES (other than those claims which result from the gross negligence or
willful misconduct of an Indemnified Party.
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9.2 Indemnification by LKS
LKS will defend, indemnify and hold harmless KHK, its AFFILIATES and
licensors and their employees, agents, officers, trustees, shareholders and
directors and each of them (the "KHK Indemnified Parties") from and against any
and all third party claims, causes of action and costs (including reasonable
attorney's fees) of any nature made or lawsuits or other proceedings filed or
otherwise instituted against the KHK Indemnified Parties resulting from or
arising out of the RESEARCH. performed by LKS or its AFFILIATES under this
Agreement (other than those claims which result from the gross negligence or
willful misconduct of an Indemnified Party.
9.3 Conditions to Indemnification
A person or entity that intends to claim indemnification under this
Section (the "Indemnitee") shall promptly notify the other party (the
"Indemnitor") of any loss, claim, damage, liability or action in respect of
which the Indemnitee intends to claim such indemnification, and the Indemnitor
shall assume the defense thereof with counsel mutually satisfactory to the
Indemnitee whether or not such claim is rightfully brought; provided, however,
that an Indemnitee shall have the right to retain its own counsel, with the fees
and expenses to be paid by the Indemnitor if Indemnitor does not assume the
defense, or if representation of such Indemnitee by the counsel retained by the
Indemnitor would be inappropriate due to actual or potential differing interests
between such Indemnitee and any other person represented by such counsel in such
proceedings. The indemnity agreement in this Section shall not apply to amounts
paid in settlement of any loss, claim
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damage, liability or action if such settlement is effected without the consent
of the Indemnitor, which consent shall not be withheld or delayed unreasonably.
The failure to deliver notice to the Indemnitor within a reasonable time after
the commencement of any such action, only if prejudicial to its ability to
defend such action, shall relieve such Indemnitor of any liability to the
Indemnitee under this Section, but the omission so to deliver notice to the
Indemnitor will not relieve it of any liability that it may have to any
Indemnitee otherwise than under this Section. The Indemnitee under this Section,
its employees and agents, shall cooperate fully with the Indemnitor and its
legal representatives in the investigations of any action, claim or liability
covered by this indemnification.
9.4 Insurance
To the extent that a party is insured for any matter which is covered
by the indemnities of Section 9.1, the Indemnitees shall be named as additional
insureds under any and all insurance policies and the insured party will provide
evidence of such insurance upon the request of the other party.
SECTION 10 - ASSIGNMENT; SUCCESSORS.
10.1 This Agreement shall not be assignable by either of the parties
without the prior written consent of the other party (which consent shall not be
unreasonably withheld), except that either party, without the consent of the
other, may assign this Agreement to a successor in interest or transferee of all
or substantially all of the portion of the business to which this Agreement
relates.
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SECTION 11 - FORCE MAJEURE.
Neither party shall be liable to the other party for damages or loss
(other than with respect to payments due LKS hereunder) occasioned by failure of
performance by the defaulting party if the failure is occasioned by war, fire,
explosion, flood, strike or lockout, embargo, or any similar cause beyond the
control of the defaulting party, provided that the party claiming this exception
has exerted all reasonable efforts to avoid or remedy such event and provided
such event does not extend for more than six (6) months.
SECTION 12 - TERMINATION.
12.1 Except as otherwise specifically provided herein and unless sooner
terminated pursuant to Sections 12.2 or 12.3 of this Agreement, this Agreement
and the licenses and rights granted hereunder shall remain in full force and
effect until KHK's obligations to pay royalties hereunder terminate. Upon
termination of KHK's obligation to pay royalties hereunder with respect to a
specific country and specific PRODUCT as to which KHK's license is then in
effect, the license granted to KHK with respect to such country and such PRODUCT
pursuant to Section 2.1 shall be deemed to be fully paid and KHK shall
thereafter have a royalty-free right to use the PATENT RIGHTS to make, have
made, use and sell such PRODUCT in such country.
12.2 (a) Upon breach of any material provisions of this Agreement by
either party to this Agreement, in the event the breach is not cured within
sixty (60) days after written notice to the breaching party by the
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other party, in addition to any other remedy it may have, the other party at its
sole option may terminate this Agreement provided that such other party is not
then in breach of this Agreement.
(b) Notwithstanding anything else to the contrary, LKS's liability for
any breach of this Agreement (including but not limited to any liability which
results from any breach of a representation or warranty) is limited to an amount
equal to the research and milestone payments received from KHK under this
Agreement.
12.3 Either party to this Agreement may, upon giving notice of
termination, immediately terminate this Agreement upon receipt of notice that
the other party has become insolvent or has suspended business in all material
respects hereof, or has consented to an involuntary petition purporting to be
pursuant to any reorganization or insolvency law of any jurisdiction, or has
made an assignment for the benefit of creditors or has applied for or consented
to the appointment of a receiver or trustee for a substantial part of its
property.
12.4 Upon any termination of this Agreement, KHK shall be entitled to,
but shall not be obligated to finish any work-in-progress for which KHK has
received firm purchase orders and to sell any completed inventory of a PRODUCT
covered by this Agreement which remains on hand as of the date of the
termination, so long as KHK pays to LKS the royalties applicable to subsequent
sales in accordance with the same terms and conditions as set forth in this
Agreement.
12.5 The obligations of Sections 4 and 9, as well as Sections 12.4,
12.5, 12.6, 12.7, 12.8 and 13.3 shall survive any termination of this Agreement.
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12.6 Upon termination of this Agreement or of the rights and licenses
granted to KHK in any country, KHK agrees not to use the LKS TECHNOLOGY and
PATENT RIGHTS or information or technology derived therefrom for the
manufacture, use or sale of PRODUCTS in any country other than those countries
in which KHK retains a license under this Agreement.
12.7 KHK agrees to use LKS TECHNOLOGY and the PATENT RIGHTS only for
the manufacture, use or sale of PRODUCTS and only and to the extent licensed
under this Agreement.
12.8 During the RESEARCH TERM, KHK may terminate this Agreement as set
forth in Section 5.13(a), provided that if notice of such termination is given
less than sixty (60) days prior to the end of an AGREEMENT YEAR, KHK shall
continue to fund RESEARCH at LKS for six (6) months after the end of the
AGREEMENT YEAR in question. Following the end of the RESEARCH TERM KHK may
terminate this Agreement on the anniversary of each AGREEMENT YEAR of this
Agreement for any reason and upon thirty (30) days' prior notice to LKS. In the
event of termination hereunder or in the event LKS terminates this Agreement as
otherwise set forth in this Agreement, ail licenses and rights granted to KHK
shall terminate forthwith and KHK shall grant to LKS an exclusive, worldwide,
royalty bearing sublicensable, license under KHK PATENTS, KHK TECHNOLOGY. and WL
TECHNOLOGY and WL PATENTS, if any, to make, have made, use, sell, offer to sell
or import PRODUCTS. If such termination occurs prior to the selection of a
DEVELOPMENT CANDIDATE, the royalty shall be * of NET SALES. If such
termination occurs after such
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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selection, the royalty shall be determined, in good faith, by agreement of the
parties but shall not be greater than * of NET SALES.
SECTION 13 - GENERAL PROVISIONS.
13.1 The relationship between LKS and KHK is that of independent
contractors. LKS and KHK are not joint venturers, partners, principal and agent
master and servant, employer or employee, and have no relationship other than as
independent contracting parties. LKS shall have no power to bind or obligate KHK
in any manner. Likewise, KHK shall have no power to bind or, obligate LKS in any
manner.
13.2 This Agreement sets forth the entire agreement and understanding
between the parties as to the subject matter thereof and supersedes all prior
agreements in this respect. There shall be no amendments or modifications to
these Agreements, except by a written document which is signed by both parties.
13.3 This Agreement shall be construed and enforced In accordance with
the laws of the Commonwealth of Massachusetts, U.S.A. without reference to its
choice of law principles.
13.4 The headings in this Agreement have been inserted for the
convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular or section or paragraph.
13.5 Any delay in enforcing a party's rights under this Agreement or
any waiver as to a particular default or other matter shall not constitute a
waiver of a party's right to the future enforcement of its
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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rights under this Agreement, excepting only as to an expressed written and
signed waiver as to a particular matter for a particular period of time.
13.6 In conducting any activities under this Agreement or in connection
with the manufacture use or sale of PRODUCT, KHK shall comply with all
applicable laws and regulations including, but not limited to, all Export
Administration Regulations of the United States Department of Commerce.
13.7 Notices. Any notices given pursuant to this Agreement shall be in
writing and shall be deemed delivered upon the earlier of (i) when received at
the address set forth below, or (ii) three (3) business days after mailed by
certified or registered mail postage prepaid and properly addressed, with return
receipt requested, or (iii) when sent, if sent, by facsimile, as confirmed by
certified or registered mail. Notices shall be delivered to the respective
parties as indicated:
If To LKS: LeukoSite, Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
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Attn: CEO
Copy to: Carella, Byrne, Bain, Gilfillan,
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Fax No. (▇▇▇) ▇▇▇-▇▇▇▇
Attn: ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇. Esq.
If To KHK: Kyowa Kakko Kogyo Co. Ltd.
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Attn: CEO
41
-41-
13.8 Any matter or disagreement under this Agreement (other than
matters involving the validity or enforceability of patents) which cannot be
resolved by the parties is to be resolved by arbitration and shall be submitted
to a mutually selected single arbitrator to so decide any such matter or
disagreement. The arbitrator shall conduct the arbitration in accordance with
the Rules of the American Arbitration Association, unless the parties agree
otherwise. If the parties are unable to mutually select an arbitrator, the
arbitrator shall be selected in accordance with the procedures of the American
Arbitration Association. The decision and award rendered by the arbitrator shall
be final and binding. Judgment upon the award may be entered in any court having
Jurisdiction thereof Any arbitration pursuant to this section shall be held in
Boston, Massachusetts, or such other place as may be mutually agreed upon in
writing by the parties.
13.9 This Agreement may be executed in any number of separate
counterparts, each of which shall be deemed to be an original, but which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date set forth above.
LEUKOSITE, INC. KYOWA HAKKO HOGYO CO. LTD.
_____________________________ ___________________________________
By:[signature appears here] By:[signature appears here]
Name:________________________ Name:______________________________
Title:_______________________ Title:_____________________________
42
APPENDIX A
LKS Patents
Application #08/709,838
__P10/MIG Receptor Designated CXCR3, Nucleic Acids and Methods of
Use Therefor
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Application #60/021,716
Antagonists of Chemokine Receptors, LeukoSite Chemotixis and
Activation and Methods of Use Therefor
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