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EXHIBIT 10.21
RESEARCH AND TECHNOLOGY DEVELOPMENT
AGREEMENT
BETWEEN
COMBICHEM, INC.
AND
SUMITOMO PHARMACEUTICALS CO., LTD.
AUGUST 18, 1997
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RESEARCH AND TECHNOLOGY DEVELOPMENT
AGREEMENT
THIS RESEARCH AND TECHNOLOGY DEVELOPMENT AGREEMENT (the "Agreement") is
entered into on August 18, 1997 (the "Effective Date"), by and between
COMBICHEM, INC., a corporation having its principal offices at 0000 Xxxxxx Xxxxx
Xx, Xxx Xxxxx, Xxxxxxxxxx ("CombiChem"), and SUMITOMO PHARMACEUTICALS CO., LTD.,
a corporation having its principal offices located at 0-0, Xxxxxxxxxx 0-xxxxx,
Xxxx-Xx, Xxxxx, 000, Xxxxx ("Sumitomo").
WHEREAS, CombiChem has developed and owns certain drug discovery
technology and intellectual property rights, including chemical library design
software, multi-parallel synthesis and purification methods, chemical libraries
suitable for high throughput biological screening assays and medicinal chemistry
(collectively, "CombiChem Technology");
WHEREAS, Sumitomo desires to utilize CombiChem Technology for its drug
discovery activities under Sumitomo Know-how concerning ***
("Objective");
WHEREAS, the parties wish to collaborate on the Objective in a Research
Program against a Collaboration Target ("Collaboration");
NOW, THEREFORE, the Parties agree as follows:
1. DEFINITIONS
1.1 "Active Compound(s)" means a compound ( or compounds ) which
(a)(i) is selected by either Party under the Research Program from
Collaboration Compounds, or
(ii) is derived from a Collaboration Compound *** *** ; and
(b) shows in vitro activity of at least ***
*** .
1.2 "Affiliate" of a Party means any corporation or other business
entity controlled by, controlling or under common control with, such Party. For
this purpose "control" shall mean direct or indirect beneficial ownership of
more than fifty percent (50%) of the voting securities or income interest in
such corporation or other business, or if not meeting the preceding
requirements, any company owned or controlled by or owning or controlling such
Party at the maximum control or ownership right permitted in the country where
such company exists.
1.3 "Collaboration" has the meaning set forth in the preamble.
1.4 "Collaboration Compound(s)" means a compound (or compounds) which
(a) is synthesized following the Effective Date for screening against the
Collaboration Target, under
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the Research Program, or (b) is a pre-existing CombiChem compound which
CombiChem desires to designate as a Collaboration Compound.
1.5 "Collaboration Target(s)" means ***
*** .
1.6 "CombiChem Technology" has the meaning set forth in the preamble.
1.7 "Confidential Information" includes, but is not limited to,
(a) all information and materials received by either Party from the
other Party pursuant to this Agreement;
(b) all information and materials developed in the course of the
Collaboration; and
(c) the material financial terms of this Agreement.
1.8 "Development Compound(s)" means a compound ( or compounds ) which
(a)(i) is a Lead Compound or (ii) is derived from a Lead Compound and
*** *** ; and
(b) are determined by Sumitomo to be appropriate for preclinical
studies for the purpose of IND filing by Sumitomo.
1.9 "Exclusivity Period" means the Research Period *** .
1.10 "Field" means all therapeutic and diagnostic indications of human
disease for the Collaboration Target.
1.11 "First Commercial Sale" of a Product shall mean the first sale for
use or consumption of such Product in a country after required marketing and
pricing approval has been granted by the governing health regulatory authority
of such country. Sale to an Affiliate or sublicensee shall not constitute a
First Commercial Sale unless the Affiliate or sublicensee is the end user of the
Product.
1.12 "Inactive Compound(s)" means a Collaboration Compound(s) ***
*** it does not have the in vitro activity required for an Active
Compound.
1.13 "Lead Compound(s)" means a compound (or compounds ) which
(a)(i) is selected from an Active Compound(s) by either Party under the
Research Program, or (ii) is derived from Active Compound(s);
(b) *** ; and
(c) shows in vitro activity with *** *** .
1.14 "Net Sales" means the gross sales invoiced by Sumitomo or its
Affiliates or licensees for Products to non-Affiliated third parties less actual
deductions of returns (including withdrawals and recalls), rebates (price
reductions, including Medicaid and similar types of rebates e.g. chargebacks),
volume (quantity) discounts, discounts granted at the time of invoicing, the
cost of transport, insurance, delivery, sales taxes and other taxes (other than
income taxes) directly linked to and included in the gross sales amount as
computed on a
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product-by-product basis for the countries concerned, whereby the amount of such
sales in foreign currencies is converted into United States dollars at the
exchange rate of the last business day for each calendar quarter as reported by
Sumitomo Bank (Tokyo).
1.15 "Other *** " means *** *** .
1.16 "Patent" means, (a) valid and enforceable Letters Patent, including
any extension (including Supplemental Protection Certificate), registration,
confirmation, reissue, continuation, divisionals, continuation-in-part,
reexamination or renewal thereof, or (b) pending applications for any of the
foregoing.
1.17 "Party" means CombiChem or Sumitomo, as the case may be; and
including their respective Affiliates and their permitted successors and
assigns.
1.18 "Product(s)" means any product containing a Development Compound
with such compound as the active ingredient and which is granted regulatory
approval by the governing health regulatory authority of the applicable country
for marketing in the Field.
1.19 "Research Management Committee" or "RMC" has the meaning set forth
in Article 5 below.
1.20 "Research Period" means the initial *** term of the Collaboration,
which can be extended in accordance with Section 6.1 below.
1.21 "Research Program" means the research to be conducted as part of
the Collaboration under the mutually-agreed research plan, and shall include,
without limitation, the activities and items set forth in Sections 2.1 and 2.2
of this Agreement.
1.22 "Royalty Term" means, in the case of any Product, in any country,
the period of time commencing on the First Commercial Sale and ending upon the
later of (a) ***
*** from the date of First Commercial Sale in such country; or (b) the
expiration of the last-to-expire Patent resulting from the Research Program
filed in the Field during the Exclusivity Period with claims covering that
Product in the relevant country.
1.23 "Territory" means *** .
2. RESEARCH COLLABORATION
2.1 CombiChem Responsibilities. CombiChem shall conduct the following
activities under the Research Program in accordance with the terms of this
Agreement and as more fully described in the Research Plan:
(a) During the Research Period, CombiChem shall (i) review data and
information regarding the Collaboration Targets provided by
Sumitomo ; (ii) based on those data and information and using the
CombiChem Technology , design compound libraries; and (iii)
synthesize compounds as provided in Section 4.4 below.
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(b) During the Research Period, CombiChem shall keep Sumitomo fully
informed of its activities performed in connection with the
Collaboration, including, without limitation, by providing
Sumitomo with data and information regarding Collaboration
Compounds prior to the meetings of the Research Management
Committee.
(c) During the Research Period, CombiChem shall provide space and
resources to accommodate the Sumitomo scientists described in
Section 2.2 below.
(d) During the Research Period , CombiChem shall provide a minimum
of *** .
(e) During the Research Period and while *** *** ,
CombiChem shall provide Sumitomo with reasonable technical
support to facilitate Sumitomo's establishment of an ***
*** *** *** *** *** .
2.2 Sumitomo Responsibilities. Sumitomo shall provide CombiChem, with
the following resources under the Research Program as more fully described in
the Research Plan:
(a) Sumitomo shall provide CombiChem with support and assistance
useful or necessary for the conduct of the Research Program,
including providing data input from in-house lead series and
screening hits, chemical intermediates, information concerning
assay methods and screening data.
(b) During the Research Period, Sumitomo shall provide CombiChem with
data and information regarding Collaboration Compounds and the
Collaboration Target assays developed by Sumitomo under the
Research Program prior to the meetings of the Research Management
Committee.
(c) During the Research Period and in connection with CombiChem
providing the services in Section 2.1(e) above , Sumitomo may
send ***
***
***
***
*** .
(d) During the Exclusivity Period, Sumitomo shall screen
Collaboration Compounds for in vitro and, where appropriate, in
vivo activity against the Collaboration Target, devoting the same
degree of attention, resources and diligence to these screening
activities as it devotes to other compounds in its own discovery
activities.
2.3 Research Plan. The Parties hereby agree that the Research Program
shall be carried out in accordance with the Research Plan which is attached
hereto as Exhibit A. The Research Management Committee shall review the Research
Plan on an ongoing basis and may make changes to the Research Plan so long as
such changes are mutually agreed to by CombiChem and Sumitomo.
2.4 Sumitomo Due Diligence. Sumitomo shall screen Lead Compounds and
endeavor to determine Development Compounds. Sumitomo shall devote the same
degree of attention, resources and diligence to its obligations above and the
development of Development Compounds as it devotes to other compounds of its own
development ("Due
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Diligence"). Timelines associated with Due Diligence for the first IND filing
are outlined in Exhibit A which timelines may be extended upon the mutual
agreement of Sumitomo and CombiChem.
2.5 Annual Reports. Following the first IND filing through First
Commercial Sale, Sumitomo shall provide CombiChem with an annual report
summarizing Sumitomo's activities in developing Development Compounds.
2.6 Third Party Licenses. Each party shall be solely responsible for any
third party license fees required to perform its obligations under this
Agreement.
3. EXCLUSIVITY
3.1 Collaboration Target Exclusivity. *** *** .
3.2 *** . An *** shall be available to both Parties for
direct or indirect use against *** following the *** .
3.3 *** . An *** shall be available to both Parties for direct or
indirect use against targets other than a Collaboration Target or *** following
the *** .
3.4 Inactive Compounds. An Inactive Compound shall be available to both
Parties for any purpose following the designation of a Collaboration Compound as
an Inactive Compound.
4. COLLABORATION COMPOUNDS
4.1 Pre-Existing Compounds. Sumitomo shall have no rights to any
pre-existing CombiChem compound unless and until such compound is designated as
a Collaboration Compound by CombiChem. CombiChem shall have no rights to any
pre-existing Sumitomo compound which is not utilized in the Research Program.
4.2 Intellectual Property Rights. Subject to Article 8, Sumitomo shall
retain all exclusive rights to all intellectual property relating solely to the
Active Compounds and resulting from the Research Program during the Exclusivity
Period and thereafter so long as Sumitomo continues to show Due Diligence. With
respect to Active Compounds , Lead Compounds , and Development Compounds ,
Sumitomo shall be responsible for filing, maintaining and prosecuting all
Patents at its sole expense . Sumitomo shall have ownership of such Patents.
Prior to the filing of any such related Patent applications , CombiChem shall
assign all intellectual property rights it may have in the Active Compound which
is necessary for development and commercialization by Sumitomo or its designee.
If Sumitomo fails to so file, maintain or prosecute such Patent or related
Patent applications, CombiChem shall have the right to request Sumitomo to do
so. If Sumitomo elects not to file, maintain or prosecute such Patent or related
Patent applications , CombiChem shall have the right to take over such filing,
maintenance or prosecution of such Patent or related Patent applications, at its
sole
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expense, and Sumitomo shall assign all intellectual property rights it may have
in the Compound which is necessary for development and commercialization by
CombiChem or its designee.
4.3 Structural Information. Neither Party shall disclose the structure
of any Active Compound to any Third Party without the other Party's written
permission, unless required to do so by law.
4.4 Supply of Collaboration Compounds. Aliquots of at least *** of any
Collaboration Compound that has been synthesized will be prepared and given to
Sumitomo. Aliquots of at least *** of *** Lead Compounds will be prepared and
given to Sumitomo upon their reasonable request. In addition, aliquots of at
least *** of *** Lead Compounds will be prepared and given to Sumitomo upon
their reasonable request. For additional requirements of samples, CombiChem
shall provide *** .
5. RESEARCH MANAGEMENT & PLAN
The design, review and conduct of the Research Program will be
coordinated by the Research Management Committee, which will meet regularly on a
mutually-agreeable schedule. The Research Management Committee may establish and
amend or revise the research plan as necessary to reflect the scientific
progress and work performed under the Research Program, such amendments to be
mutually agreed to by Sumitomo and CombiChem. The Research Management Committee
will consist of an equal number of members from Sumitomo and CombiChem and will
include appropriate representatives from Sumitomo and CombiChem as mutually
agreed. The co-chairs of the Research Management Committee will initially be the
Vice President, Chemistry of CombiChem and a Research Manager of Sumitomo and
subsequently may change as mutually-agreed upon by the Parties. Decisions of the
Research Management Committee shall be by consensus. At the end of Research
Period, the Research Management Committee shall define Lead Compounds.
6. RESEARCH PERIOD, EXTENSION AND TERMINATION OF
RESEARCH PROGRAM
6.1 Research Period : Option to extend the Research Period. The initial
term of the Collaboration shall be the Research Period. Sumitomo shall have the
right to extend the Research Period for up *** periods upon mutual agreement .
To extend the Research Period , Sumitomo must notify CombiChem no later than ***
prior to the then-current expiration date and the Parties shall negotiate in
good faith the terms and conditions of any such extension.
6.2 Termination of Research Program. The Research Program may be
terminated by a Party *** days following the uncured material breach of
obligations under the Research Program of the other Party.
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7. PAYMENT OBLIGATIONS
7.1 Program Funding. Sumitomo shall support CombiChem's efforts in
conducting the Research Program by making payments in the following amounts at
the following times:
*** ***
*** ***
*** ***
7.2 Milestone Payments. Within thirty (30) days of the occurrence of a
development milestone shown in Exhibit B , whether such milestone is triggered
by the activities of Sumitomo or those of its sublicensee , Sumitomo shall pay
CombiChem the related milestone payment in United States dollars. The schedule
for such payments is set forth in Exhibit B of this Agreement.
7.3 Royalties. During the Royalty Term, Sumitomo will pay CombiChem a
running royalty of *** of Net Sales in all countries in the Territory
*** .
***
***
With respect to sales in *** , during the Royalty Term , Sumitomo will
pay CombiChem a running royalty of *** of Net Sales. All Royalty
payments due to CombiChem under this Agreement shall be paid in United States
dollars within *** of the end of each calendar quarter, in case Products
are sold by Sumitomo *** *** *** . Each payment of
royalties shall be accompanied by a report of Net Sales of Products in
sufficient detail to permit confirmation of the accuracy of the royalty payment
made. 7.4 Manner and Place of Payment. Royalty payments and reports for Net
Sales of Products shall be calculated in local currencies and reported for each
calendar quarter. All payments owed under this Agreement shall be made by wire
transfer to the bank account to be designated by CombiChem separately with at
least fifteen (15) business days prior written notice to Sumitomo.
7.5 Records and Audit. During the term of this Agreement and for a
period of *** *** , Sumitomo shall keep complete and accurate
records pertaining to the sale or other disposition of Products in sufficient
detail to permit CombiChem to confirm the
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accuracy of all payments due hereunder. CombiChem shall have the right to cause
an independent certified public accounting firm reasonably acceptable to
Sumitomo to audit such records to confirm Sumitomo's Net Sales for the preceding
year, Any information obtained during such audit shall be treated as
Confidential Information. Such audits may be exercised during normal business
hours of Sumitomo no more than once each year. CombiChem shall bear the full
cost of such audit unless such audit discloses a variance of more than *** from
the amount of the Net Sales reported by Sumitomo for such audited period. In
such case, Sumitomo shall bear the full cost of such audit.
7.6 Taxes. All income and other taxes levied on account of the royalties
and other payments accruing to CombiChem under this Agreement shall be paid by
CombiChem, including taxes levied thereon as income to CombiChem. If provision
is made in law or regulation for withholding, such tax shall be deducted from
the royalty or other payment made by Sumitomo to the proper taxing authority and
a receipt of payment of the tax secured and promptly delivered to CombiChem.
Each Party agrees to assist the other Party in claiming exemption from such
deductions or withholdings under any double taxation or similar agreement or
treaty from time to time in force.
8. LICENSE GRANT ***
8.1 CombiChem License Grant to Sumitomo. Subject to the terms and
conditions of this Agreement, CombiChem hereby grants to Sumitomo *** ,
***
***
*** .
8.2 *** . ***
***
***
***
***
***
*** .
8.3 Sumitomo License Grant to CombiChem. Subject to the terms and
conditions of this Agreement and following the failure of Sumitomo to develop
and commercialize with Due Diligence a Lead Compound, a Development Compound or
Product, as the case may be, ( "Returned Compound"), Sumitomo shall grant to
CombiChem *** *** under those Sumitomo Patents and know-how
which are resulting from the Research Program and related exclusively to the
Returned Compound *** *** .
8.4 Rights Outside the Field. Each of Sumitomo and CombiChem shall have
rights to *** outside the Field.
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9. TERM AND TERMINATION OF THE AGREEMENT
9.1 Term. The term of this Agreement shall commence upon the Effective
Date of this Agreement, and shall expire on the expiration of the last royalty
obligation under this Agreement, except as provided hereunder.
9.2 Termination by Sumitomo or CombiChem. If either Party materially
breaches this Agreement and fails to remedy that breach within *** of receiving
written notice thereof from the other Party, or enters into any arrangement of
composition with its creditors or goes into liquidation, insolvency, bankruptcy,
receivership or reorganization proceedings, whether voluntarily or compulsorily
which is not dismissed within *** , then the other Party may at any time, by
notice in writing or by telefax, terminate this Agreement.
9.3 *** . ***
***
***
*** .
9.4 After Termination. Any termination of this Agreement or the Research
Program shall be without prejudice to the accrued rights of either Party prior
to the termination. In case of termination of this Agreement or the Research
Program by CombiChem according to the Article 9.2 above, all royalty and
milestone obligations for any Collaboration Compound shall survive any such
termination.
10. CONFIDENTIAL INFORMATION
10.1 Nondisclosure. During the term of the Collaboration and for a
period of *** *** after termination thereof, each Party will
maintain all Confidential Information in trust and confidence and will not
disclose any Confidential Information to any third party or use any Confidential
Information for any purpose except (i) as expressly authorized by this
Agreement, (ii) as required by law or court order, (iii) to its consultants,
subcontractors or agents who need to know to accomplish the purposes of this
Agreement. Each Party may use such Confidential Information only to the extent
required to accomplish the purposes of this Agreement. Each Party will use at
least the same standard of care as it uses to protect proprietary or
confidential information of its own to ensure that its Affiliates, employees,
agents, consultants and other representatives do not disclose or make any
unauthorized use of the Confidential Information. Each Party will promptly
notify the other upon discovery of any unauthorized use or disclosure of the
Confidential Information.
10.2 Exceptions. Confidential Information shall not include any
information which the receiving Party can prove by competent evidence: (a) is
now, or hereafter becomes, through no act or failure to act on the part of the
receiving Party, generally known or available; (b) is known by the receiving
Party at the time of receiving such information, as evidenced by its records;
(c) is hereafter disclosed to the receiving Party by a Third Party, as a matter
of right and without restriction on disclosure; (d) is independently developed
by the
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receiving Party without the aid, application or use of Confidential Information;
or (e) is the subject of a written permission to disclose provided by the
disclosing Party.
11 PUBLICATIONS AND PUBLIC STATEMENTS
11.1 Publications. Neither Party shall publish any information with
respect to Collaboration Compounds or Development Compound without the prior
written permission of the other party during the Exclusivity Period. Such
permission shall be approved or disapproved within *** of written request for
permission. Such permission shall not be unreasonably withheld.
11.2 Public Statements. Neither Party shall use the name of the other
Party in any public statement , prospectus , annual report or press release
without the prior written approval of the other Party , which may not be
unreasonably withheld or delayed ; provided, however, that both Parties shall
endeavor in good faith to give the other Party a minimum of
*** to review such public statement , prospectus , annual report or press
release ; and provided , further , that if a Party does not approve such public
statement , either Party may still use the name of the other Party in any public
statement , prospectus , annual report or press release without the prior
written approval of the other Party , if such Party is advised by counsel that
such disclosure is required to comply with applicable law.
12. ***
12.1 ***
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12.2 *** ***
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(i) ***
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(ii) ***
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(iii) ***
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12.3 *** ***
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13. ASSIGNABILITY
This Agreement may not be assigned by either Party without the prior
written consent of the other Party; provided, however, that either Party may
assign this Agreement, in whole or in part, to an Affiliate or to a successor of
a Party in connection with the merger, consolidation or sale of all or
substantially all of such Party's assets or that portion of its business
pertaining to the subject matter of this Agreement.
14. DISPUTE RESOLUTION PROCEDURES
14.1 Arbitration. All disputes arising in connection with this Agreement
shall be finally settled by arbitration under the Rules of Conciliation and
Arbitration of the International Chamber of Commerce in force at the time of
such dispute. The arbitration shall take place in the United States by three
arbitrators appointed in accordance with such Rules.
14.2 Injunctive Relief. Nothing contained in this Section or any other
provisions of this Agreement shall be construed to limit or preclude a Party
from bringing any action in any court of competent jurisdiction for injunctive
or other provisional relief to compel the other Party to comply with its
obligations hereunder before or during the pendency of arbitration proceedings.
15. NOTICES
Any notice required or permitted to be given hereunder shall be deemed
sufficient if sent by facsimile letter or overnight courier , or delivered by
hand to Sumitomo or CombiChem at the respective addresses and facsimile numbers
as set forth below or at such other address and facsimile number as either Party
hereto may designate.
if to CombiChem, to:CombiChem, Inc.
0000 Xxxxxx Xxxxx Xx Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: President
Fax number: (000) 000-0000
with a copy to: Xxxxxxx, Xxxxxxx & Xxxxxxxx LLP
000 Xxxx X Xxxxxx, Xxxxx 0000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xxxx X. Xxxxxxx, Esq.
Fax number: (000) 000-0000
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if to Sumitomo, to: Research Coordination & Planning Department
1-98, Kasugadenaka 0 -xxxxxx , Xxxxxxxx-xx
Xxxxx 000 Xxxxx
Sumitomo Pharmaceuticals Co., Ltd.
Attn.: Dr. Kei-ichi Ono
Fax number: 00-000-0000
16. SURVIVAL
The provisions of Sections 8.4 and 17.6, and Article 12 shall survive
termination of this Agreement in addition to those provisions which by their
terms survive.
17. ADDITIONAL TERMS
17.1 Entire Agreement. This Agreement and that certain Confidentiality
Agreement between CombiChem and Sumitomo dated February 5, 1997 constitutes the
entire understanding between the Parties with respect to the subject matter
hereto and supersedes and replaces all previous negotiations, understandings,
representations, writings and contract provisions and rights relating hereof.
The Parties agree that all services provided hereunder shall be subject to and
governed by the terms and provisions set forth herein, and none of the terms and
conditions contained on any proposal, purchase order, invoice or other writing
shall have any effect or change the provisions of this Agreement.
17.2 Amendment; No Waiver. No provision of this Agreement may be
amended, revoked or waived except by a writing signed and delivered by an
authorized officer of each Party. Any waiver on the part of either Party of any
breach or any right or interest hereunder shall not imply the waiver of any
subsequent breach or waiver of any other right or interest.
17.3 Validity. The invalidity or unenforceability of any provision of
this Agreement shall not affect the validity or enforceability of any other
provision of this Agreement, each of which shall remain in full force and effect
.
17.4 Headings. The descriptive headings are inserted for convenience of
reference only and are not intended to be part of or to affect the meaning of or
interpretation of this Agreement.
17.5 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, and all of which
together shall be deemed to be one and the same instrument.
17.6 Governing Law. This Agreement shall be governed by and construed
and enforced in accordance with the laws of the State of California, without
reference to conflicts of laws principles.
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IN WITNESS WHEREOF, the parties have executed this Agreement to be
effective as of the Effective Date.
COMBICHEM, INC. SUMITOMO PHARMACEUTICALS CO., LTD.
By: /s/ Xxxxxxx Xxxxx, Xx. By: /s/ X. Xxxxxxxx
------------------------------- -------------------------------
Its: President and CEO Its: X. Xxxxxxxx
------------------------------- -------------------------------
President
-------------------------------
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EXHIBIT A
I. Research Plan
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II. CRITERIA FOR ACTIVE COMPOUNDS, LEAD COMPOUNDS AND DEVELOPMENT COMPOUNDS
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III. DUE DILIGENCE
Sumitomo will find the IND after a selection of a Development compound
within *** which may be extended upon Mutual Agreement of Sumitomo and
CombiChem.
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EXHIBIT B
FINANCIAL SUMMARY
($ IN USD MILLIONS)
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EXHIBIT C
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