LICENSE AND SUPPLY AGREEMENT
This License and Supply Agreement ("Agreement"), effective as of the 30th
day of June 1998, is by and between Japan Energy Corporation, a corporation duly
organized and existing under the laws of Japan and having its principal place of
business at 00-0, Xxxxxxxxx 0-xxxxx, Xxxxxx-xx, Xxxxx 000-0000, Xxxxx
(hereinafter referred to as "JE"), and Agouron Pharmaceuticals, Inc., a
corporation duly organized and existing under the laws of the State of
California, U.S.A., and having its principal place of business at 00000 Xxxxx
Xxxxxx Xxxxx Xxxx, Xx Xxxxx, Xxxxxxxxxx 00000, U.S.A. (hereinafter referred to
as "Agouron"). JE and Agouron are sometimes hereinafter each referred to as a
Party (collectively "Parties") to this Agreement.
BACKGROUND
JE possesses technical information and know-how pertaining to a certain
pharmaceutical compound designated JE-2147 and its related compounds that may be
useful in the treatment and prevention of Human Immunodeficiency Virus
infections and other diseases.
The Parties entered into a Confidentiality Agreement effective December 31,
1997 (the "Confidentiality Agreement") and a Material Transfer Agreement
effective December 31, 1997 (the "Material Transfer Agreement"), pursuant to
which Agouron has undertaken certain evaluations of JE-2147.
JE holds patents rights pertaining to JE-2147 and its related compounds.
Agouron desires to obtain a license from JE to enable Agouron to develop
and commercialize Product (as hereinafter defined) in certain countries of the
world, and JE is willing to grant such license on the terms and conditions
hereinafter set forth.
The Parties wish to cooperate under the terms of this Agreement to optimize
the development and commercialization of Product.
The Parties also wish to confirm their arrangement regarding the supply of
Compound by JE to Agouron and the supply of Product by Agouron to JE (both terms
as hereinafter defined).
On June 30, 1998, the parties executed and delivered to each other, by
telefax, a prior version of this Agreement. The parties now wish to supersede
such prior version of this Agreement and to formally enter into this revised
version of this Agreement.
NOW, THEREFORE, in consideration of the premises, and the mutual covenants,
benefits and obligations set forth herein, the Parties agree as follows:
ARTICLE I - DEFINITIONS
When used in this Agreement, the following terms shall have the meanings
set out in this Article I. Except as otherwise explicitly provided, all
references to Articles and Sections shall refer to the Articles and Sections of
this Agreement, and all references to Attachments, Exhibits and Schedules shall
refer to the Attachments, Exhibits and Schedules to this Agreement, all of which
are incorporated herein by reference.
Section 1.01 "Affiliate" means any person, organization or entity that is,
directly or indirectly, controlling, controlled by, or under common control with
JE or Agouron, as the case may be. The term "control" (including, with
correlative meaning, the terms "controlled by" and "under common control with"),
as used with respect to any person, organization or entity, means the
possession, directly or indirectly, of the power to direct, or cause the
direction of, the management and policies of such person, organization or
entity, whether through the ownership of voting securities, or by contract or
court order or otherwise. The ownership of voting securities of a person,
organization or entity shall not, in and of itself, constitute "control" for
purposes of this definition, unless said ownership is of a majority of the
outstanding securities entitled to vote of such person, organization or entity.
Affiliate shall also mean a limited partnership in which a subsidiary of Agouron
and/or JE is a general partner.
Section 1.02 "Combination Product" means *
Section 1.03 "Compound" means the chemical compound known by the JE code
name JE-2147 ("JE-2147"), whose chemical structure is as follows:
*
(chemical structure)
The definition of Compound also means: (i) *
Section 1.04 "Compound Supply Plan" means the supply plan under which JE
will provide Compound to Agouron in accordance with the provisions of Section
4.04.
Section 1.05 "Control," "Controlled" or "Controlling" means *
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Section 1.06 "Development Program" means *
Section 1.07 "Development Program Patent Rights" means *
Section 1.08 "Development Program Technology" means *
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Section 1.09 "Dossier" means the document that is filed with and approved
by a government or health authority for purposes of Registration, for example, a
Marketing Authorization Application.
Section 1.10 "Effective Date" means June 30, 1998.
Section 1.11 "EMEA" means the European Agency for the Evaluation of
Medicinal Products.
Section 1.12 "FDA" means the United States Food and Drug Administration.
Section 1.13 "Field" means *
Section 1.14 "Initial Commercial Sale" means the first commercial sale of a
Product *
Section 1.15 "JE Territory" means Japan, Taiwan, South Korea and North
Korea.
Section 1.16 "JE Patent Rights" means: *
Section 1.17 "JE Technology" means *
Section 1.18 "Licensed Territory" means all countries of the world, except
for Japan, Taiwan, South Korea and North Korea.
Section 1.19 "MAA" means Marketing Authorization Application.
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Section 1.20 "Major Market European Country" means the United Kingdom,
France, Germany, Spain or Italy.
Section 1.21 "Net Sales" means the gross amount invoiced for Product by
Agouron, its Affiliates and sublicensees to non-Affiliated third parties, other
than separately itemized transportation costs, and sales taxes and other taxes
that are directly linked to and included in the gross amount invoiced, as
computed on a product-by-product basis for the countries concerned, less: *
Section 1.22 "New Drug Application" or "NDA" means a new drug application,
product license application or comparable regulatory submission to the FDA, the
EMEA or an equivalent agency of a country in the Territory for permission to
commence commercial sale of a Product.
Section 1.23 "Patent Rights" means, collectively, *
Section 1.24 "Product" means any *
Section 1.25 "Registration" means the official approval by the government
or health authority in a country (or supra-national organization, such as the
European Agency for the Evaluation of Medicinal Products) that is required for a
Product to be offered for sale in such country, including such authorizations as
may be required for the production, importation, pricing, reimbursement and sale
of such Product, and for subsequent regulatory filings for line extensions
and/or additional indications of such Product.
Section 1.26 "Territory" means *
Section 1.27 "Trade Dress" means any materials directly supporting the
commercialization of a Product, including, but not limited to, packaging,
package inserts, advertising or selling aids, brochures, mailings and/or other
marketing or packaging materials.
Section 1.28 "Trademark(s)" means any trademark selected and owned by a
Party and registered (or applied for) by such Party, its Affiliate(s) and
sublicensee(s) in the Territory for use in connection with the marketing of
Products. The definition of Trademark(s) shall not refer to trade names or
designs such as logos used by a Party to designate the name of such Party.
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Section 1.29 "United States" or "U.S." means the United States of America,
its territories, possessions and protectorates (including Puerto Rico), and the
District of Columbia.
Section 1.30 "Valid Claim" means a *
ARTICLE II - COMMERCIAL RIGHTS
Section 2.01 License Grants. To implement the development and
commercialization of Compound and/or Products, the Parties, subject to the other
applicable provisions of this Agreement, grant and accept the license rights
provided below in this Article II.
(a) Subject to the provisions of Section 2.01(c), and Article V, JE grants
Agouron the exclusive right, even as to JE (with right of sublicense), to use,
offer for sale, sell and/or import in or into the Licensed Territory, Compound
and Products under applicable JE Patent Rights and Development Program Patent
Rights, and using applicable JE Technology and Development Program Technology.
(b) *
(c) *
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(d) *
(e) Agouron grants JE *
(f) Agouron grants JE *
(g) Agouron grants JE *
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(h) Subject to the provisions of Section 4.04, Agouron shall have *
Subject to the provisions of Section 4.04, JE shall have a *
(i) *
(j) *
(k) *
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(l) Agouron agrees to use reasonable efforts to not sell Product in the
Licensed Territory to persons who it knows, or has reason to know, will resell
and/or transfer such Product outside of the Licensed Territory.
Section 2.02 Discontinuance of the Development Program
(a) Agouron shall, in a timely manner, use reasonable diligence in the
development and Registration of a Product in the Field in the Licensed
Territory. Reasonable diligence means a commercially reasonable standard of
effort based on the commercial potential for such Product in the Licensed
Territory. Development efforts undertaken by Agouron's Affiliates and
sublicensees shall be attributed to Agouron. *
(b) *
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Section 2.03 Diligent Efforts to Market *
ARTICLE III - SHARING AND PROTECTION OF INTELLECTUAL PROPERTY
Section 3.01 Patents.
(a) *
10
(b) *
(c) *
(d) *
(e) *
11
(f) *
(g) *
(h) *
(i) *
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(j) *
(k) *
(l) *
Section 3.02 Infringement of Patents of Third Parties. Each Party, its
Affiliates and sublicensees, and their respective employees and agents shall use
diligent efforts to avoid known
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infringement of patents of any third party *
Section 3.03 Trademarks. *
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Section 3.04 Information Exchange. *
Section 3.05 Confidentiality. Except as otherwise expressly specified
in this Agreement and except for the proper exercise of any license rights
granted or rights reserved under this Agreement, JE and Agouron shall each
keep in confidence and shall each use its best efforts to cause its
respective Affiliates, employees, directors, agents, consultants, clinical
research associates, outside contractors, clinical investigators and
sublicensees to whom it is permitted to disclose information pursuant to
the terms of this Agreement to retain in confidence all confidential and
proprietary information of the other Party, including the *
Without limiting the foregoing, JE and Agouron shall each exercise the
same degree of diligence and care with respect to the above-described
information as it exercises with respect to its other proprietary
information. Each Party represents to the other Party that it maintains
policies and procedures designed to prevent the unauthorized disclosure of
its proprietary data and information. *
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The preceding obligations of confidentiality shall be waived as to
information that the Party claiming waiver can demonstrate, based on
written records: (i) was in the public domain at the time of disclosure
hereunder; (ii) comes into the public domain through no fault of the Party
claiming waiver; (iii) was known to the Party claiming waiver prior to its
disclosure under this Agreement, unless such information was obtained from
the other Party on a confidential basis; (iv) is disclosed on a
non-confidential basis to the Party claiming waiver by a third party having
a lawful right to make such disclosure on a non-confidential basis; (v) is
published with the prior mutual agreement of the Parties, after having
given consideration to appropriate commercial factors; (vi) comes into the
public domain through governmental publication of a patent application; or
(vii) is required to be disclosed to file a patent or other regulatory
application or to comply with applicable laws and regulations. *
The Parties acknowledge and agree that the Parties' rights and
obligations under the Confidentiality Agreement and the Material Transfer
Agreement between the Parties which were both originally entered into on
December 22, 1997 are hereby superseded by the provisions of this Section
3.05.
Section 3.06 Publication. JE and Agouron each acknowledges the
interests of the other Party in publishing certain of the results of its
development and Registration of a Product to obtain recognition within the
scientific community and to advance the state of scientific knowledge. The
Parties also recognize their mutual interests in obtaining valid patent
protection for their drug products. Consequently, a Party, its employees or
consultants wishing to make a publication shall *
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ARTICLE IV - DEVELOPMENT AND COMMERCIALIZATION STRUCTURE
Section 4.01 Coordination. Coordination of the Parties' development
and commercialization efforts for Compound and Products in the Licensed
Territory shall be carried out as specified in Sections 4.02 and 4.03.
Section 4.02 Development and Registration; Responsibility for
Development Costs. JE and Agouron acknowledge their mutual intention to
cooperate in a commercially reasonable manner in the timely development of
Compound and Products in the Territory. The Parties further acknowledge
their mutual willingness to discuss ad hoc agreements to establish
appropriate mechanisms for such cooperation. Recognizing the importance of
timely initiation of development activities, however, JE and Agouron agree
to the following basic approach to development of Compound and Products in
the Licensed Territory, and to the conduct and funding of their respective
development activities.
(a) *
(b) The Parties acknowledge that it will be necessary to amend and
update the Development Program as additional information becomes available
concerning the prerequisites necessary for Registration of Product in the
Licensed Territory. *
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(c) As soon as possible after the execution of this Agreement, the
Parties shall promptly reach agreement on the basic terms under which JE
will manufacture and supply Compound to Agouron, its Affiliates and
sublicensees *
(d) Agouron shall be responsible *
(e) Agouron,* , shall be responsible for submission of Dossiers for a
Product to the regulatory authorities in the Licensed Territory in pursuit
of approvals to sell such Product and *
All Dossiers for Product in the Licensed Territory shall be owned by
and be in the name of Agouron.
(f) JE shall cooperate with Agouron to *
(g) JE will be responsible for *
(h) JE shall be responsible *
(i) To the extent required to support Registrations of a Product (such
as for Investigational New Drug Applications and New Drug Applications),
Agouron shall have
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*
(j) Each Party agrees to use its diligent efforts in responding in a
timely manner, *
(k) Agouron shall keep JE informed of its progress in the development
and Registration of Products. This information exchange shall include, *
(l) JE and Agouron shall each use qualified persons in the development
activities of the Development Program.
(m) All work in connection with the development of Compound or
Products, to the extent required by applicable laws or regulations, shall
be conducted in accordance with Good Laboratory Practices, Good
Manufacturing Practices and Good Clinical Practices, as such rules of
practice are amended from time to time. Each Party in the conduct of its
activities shall comply with all applicable laws, rules and regulations of
each jurisdiction within the Territory
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that are applicable to the development, testing, manufacture, labeling,
packaging, storage, marketing, distribution, sale, promotion and
import or export of Product.distribution, sale, promotion and import
or export of Product.
(n) *
Section 4.03 Marketing. * JE and Agouron agree to the following basic
approach to the marketing of Products in the Licensed Territory, and to the
conduct of their marketing activities in their respective marketing
territories.
(a) Agouron shall be responsible for *
(b) *
(c) Agouron shall keep JE informed of Agouron's current and planned
marketing activities in the Licensed Territory. *
JE shall keep Agouron informed of JE's marketing activities in the JE
Territory. *
(d) Unless prohibited by law or regulation, the labeling for a Product
in the countries in the Licensed Territory shall *
20
(e) *
(f) Agouron and JE shall each use qualified persons in its marketing
activities for a Product in its respective marketing territories.
(g) Agouron shall be responsible for responding, in a timely manner, *
(h) Each Party, its Affiliates and sublicensees, agrees throughout the
duration of this Agreement to notify the other Party immediately in English
of *
21
(i) Each Party further agrees to immediately notify the other Party of
any information *
The information to be provided hereunder shall be provided in English.
(j) Without limiting the foregoing, it is also understood that each
Party may notify its Affiliates or sublicensees of *
Section 4.04 Supply of Compound. It is anticipated that timely
development of Compound and/or a Product will require the manufacture of
significant amounts of the Compound, and that successful worldwide
commercialization of a Product will require annual production of large
quantities of the Compound.
(a) In accordance with the provisions of Section 4.04, Agouron shall
purchase from JE, and JE shall timely deliver Compound for use in the
development and Registration activities for Compound and/or Product,
including using Compound to make Product to be used in clinical studies and
trials and for special license sales. *
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(b) In accordance with the provisions of Section 4.04, Agouron shall
purchase from JE, and JE shall timely deliver Compound for use in making
the finished dosage form(s) of Product to be sold in the Licensed
Territory, *
(c) JE shall maintain books of account and complete and accurate
records of all of its FBMCC of procuring and/or producing such Compound *
(d) *
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(e) *
(i)
(ii)
(iii)
24
(iv) Sale and delivery of Compound will be subject to an agreed-upon
form of purchase order being issuedby Agouron and accepted by JE. *
(v) *
(vi) *
(vii) *
(f) *
25
(i) *
(ii) *
(g) *
Section 4.05 Supply of Product. The details for manufacturing Product
will be determined after the execution of this Agreement, according to the
following conditions:
(a) Agouron shall be responsible for manufacturing Product.
(b) *
(c) *
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(d) *
(e) *
(i) *
(ii) *
27
(iii) *
(iv) *
(v) *
(f) *
(g) *
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(h) *
ARTICLE V - ADVANCE PAYMENTS AND ROYALTIES
Section 5.01 Advanced Payments and Royalties.
(a) Subject to the terms and conditions of this Agreement and in
consideration for the rights granted to Agouron under this Agreement,
Agouron shall make the following one-time-only payments to JE:
PAYMENT
MILESTONE EVENT (U.S. Dollars)
(i) Within thirty (30)days of execution of this Agreement
(actually paid July 17, 1998) $6,000,000
(ii) Within thirty (30) days of the earlier of: (1) the first completion
of a Phase I Clinical Study for any Product;
or (2) September 30, 2000* $3,000,000
(iii)Within thirty (30) days of the earlier of: (1)
the first completion of a Pilot Phase II Study
for any Product; or (2) December 31, 2000* $3,000,000
(iv) Within thirty (30) days of first U.S. NDA or
EMEA filing for any Product $6,000,000
(v) Within thirty (30) days of first U.S. NDA
approval for any Product $3,000,000
(vi) Within thirty (30) days of the first European Commission
approval for any Product (but not before receipt
of pricing approval for such Product in
at least one (1) Major Market European Country) $5,000,000
TOTAL PAYMENTS: $26,000,000
* *
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*
(b) *
(c) The Parties agree that the calculation of the amount of royalties
due shall be subject to and in accordance with the following provisions:
(i) *
(ii) *
(iii) *
30
(iv) *
(v) *
(vi) *
(vii) *
(viii) *
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Section 5.02 General Licensing Terms.
(a) *
(b) The Parties agree that the accounting and payment of royalties
shall comply with the following terms and conditions:
(i) *
(ii) *
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(iii) *
(iv) Agouron shall maintain and cause its Affiliates and sublicensees
to maintain books of account and complete and accurate records pertaining
to the sale or other disposition of Products and of the royalties and other
amounts payable under this Agreement in sufficient detail to *
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(c) *
(d) *
Section 5.03 Foreign Currency.
(a) Net Sales and any milestone and royalty amounts shall be stated in
United States dollars. Remittal of milestone payments and royalties shall
be made in United States dollars. *
(b) *
ARTICLE VI - TERM AND TERMINATION
Section 6.01 Termination for Breach *
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Section 6.02 Termination by Agouron.
(a) *
(b) *
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(c) *
Section 6.03 Termination by Mutual Agreement. The Parties may at any
time terminate this Agreement, in part or in its entirety, by mutual
written agreement.
Section 6.04 Termination Upon Bankruptcy.. In the event that a Party
is subject to any proceeding under the bankruptcy laws, including
appointment of a receiver, trustee, liquidator or other custodian of its
business or substantially all of its assets, and such proceeding, if
involuntary, is not dismissed or discharged within one hundred fifty (150)
days after such proceeding is instituted, or upon the liquidation,
dissolution, or winding up of its business, then this Agreement, at the
election of the other Party, shall be terminated in its entirety for cause
upon a notice in writing of at least fifteen (15) days from the Party who
is not bankrupt or insolvent.
Section 6.05 Disposition of Inventory In the event of the cancellation
or termination of any license rights with respect to a Product, the
inventory of such Product may be sold for up to * after date of
cancellation or termination, provided the required payments, if any, are
paid thereon.
Section 6.06 Effect of Termination. *
ARTICLE VII - WARRANTIES AND COVENANTS;
INDEMNITIES; INSURANCE; DISPUTE RESOLUTION
Section 7.01 Warranties and Covenants.
(a) Each Party represents and warrants to the other Party that it has
the legal power, authority and right to enter into this Agreement and to
perform all of its respective obligations set forth herein, including the
attachments hereto.
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(b) JE acknowledges and represents that the patents and patent
applications listed in Schedule 2 are the only patents and patent
applications included within the JE Patent Rights that are jointly owned by
JE and a third party, and that such patents and patent applications are
only subject to the conditions and restrictions noted on Schedule 2 and,
except as otherwise noted on Schedule 2, that the license of such JE Patent
Rights to Agouron under the terms of this Agreement do not require the
consent of such joint owner. *
(c) JE represents and warrants that, as of the date this Agreement is
executed, it was not aware of the existence of any patent applications or
patents owned and Controlled by a third party covering Compound that might
materially prevent the Parties from commercializing Compound in the
Licensed Territory, except for the patent application listed in Schedule
7.01(c).
(d) JE represents and warrants that: (i) it has the right to grant the
licenses set forth in Article II; and (ii) there are no suits, claims or
proceedings pending in any court or by or before any governmental body or
agency with respect to the JE Patent Rights or JE Technology that would
materially interfere with the ability of Agouron to fully exercise the
licenses granted to it under this Agreement, including the exclusive
license rights under Section 2.01(a). Agouron represents that, to the best
of its knowledge, it does not have any know-how, trade secret, experimental
data, formula, expert opinion, experimental procedure or other confidential
and/or proprietary information specifically concerning the Compound,
intermediates thereof, or a Product that was developed or acquired by or on
behalf of Agouron before the Effective Date of this Agreement that is
necessary for either: (i) the formulation (including sustained-release
formulations), manufacture, use and/or application of Product; or (ii)
obtaining Registration of Product, including, but not limited to,
information and data arising out of pre-clinical and clinical trials
involving Product and all NDA applications for Product, and which is under
the Control of Agouron.
(e) Each Party covenants that it shall not commit any act or fail to
take any action that, in any significant way, would be in conflict with its
material obligations under this Agreement and the attachments hereto.
(f) Each Party promises to comply in all material respects with the
terms of the licenses granted to it under this Agreement, and with all
federal, state, local and foreign laws, rules and regulations applicable to
the development, manufacture, distribution, import and export, and sale of
pharmaceutical products pursuant to this Agreement.
(g) EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, EACH OF
THE PARTIES MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER INCLUDED WITHIN
THE CLAIMS OF THE PATENT RIGHTS, INCLUDING THE COMPOUND. THE PARTIES
UNDERSTAND AND AGREE THAT DEVELOPMENT AND COMMERCIALIZATION OF COMPOUND
AND/OR PRODUCTS WILL INVOLVE APPROVAL BY REGULATORY AUTHORITIES, AND THAT
NO PARTY IS GUARANTEEING THE SAFETY OR EFFICACY OF COMPOUND AND/OR
PRODUCTS,
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OR THAT COMPOUND AND/OR PRODUCTS WILL RECEIVE THE REQUIRED APPROVALS.
Section 7.02 Indemnities; Insurance.
(a) Agouron shall indemnify and hold harmless JE and its Affiliates,
employees, and agents (a "JE Indemnified Party") from and against any and
all liabilities, losses, damages, costs, or expenses (including reasonable
investigative and attorneys' fees) which the JE Indemnified Party may
incur, suffer or be required to pay resulting from or arising in connection
with any product liability or other claims (other than claims for patent
infringement) arising from the use by any person of any Product, to the
extent such product liability or other claim results from the negligent,
reckless or intentional misconduct of Agouron, its Affiliates or
sublicensees, or their respective employees and agents, or on account of
Agouron's failure to fulfill its obligations or undertakings under this
Agreement; provided, however, that in no event shall Agouron be liable to a
JE Indemnified Party for any indirect, incidental, special or consequential
damages, including loss of revenues or profits from sales of Products.
(b) JE shall indemnify and hold harmless Agouron and its Affiliates,
employees, and agents (an "Agouron Indemnified Party") from and against any
and all liabilities, losses, damages, costs, or expenses (including
reasonable investigative and attorneys' fees) that the Agouron Indemnified
Party may incur, suffer or be required to pay, resulting from or arising in
connection with any product liability or other claims (other than claims
for patent infringement) arising from the use by any person of any Product,
to the extent such product liability or other claim results from the
negligent, reckless or intentional misconduct of JE, its Affiliates or
sublicensees, or their respective employees and agents, or on account of
JE's failure to fulfill its obligations or undertakings under this
Agreement; provided, however, that in no event shall JE be liable to an
Agouron Indemnified Party for any indirect, incidental, special or
consequential damages, including loss of revenues or profits from sales of
Products.
(c) To the extent that a product liability or other claim (other than
a claim for patent infringement) results from the negligent, reckless or
intentional misconduct of more than one Party, their Affiliates,
sublicensees, or their respective employees and agents, the Parties agree
to share in an equitable manner such liabilities, losses, damages, costs,
or expenses in proportion to the relative fault of each of the Parties,
their Affiliates, sublicensees, or their respective employees and agents.
(d) Unless the Parties agree otherwise, all other liabilities, losses,
damages, costs, or expenses (including reasonable investigative and
attorneys' fees) under this Section 7.02 relating to or involving a Product
in a country, except as provided by the terms of Sections 7.02(a), (b) and
(c), shall be the responsibility of the Party marketing such Product in
such country. The Party marketing a Product in a country shall indemnify
the non-marketing Party in such country from and against any and all
liabilities, losses, damages, costs, or expenses (including reasonable
investigative and attorneys' fees) which such non-marketing Party may
incur, suffer or be required to pay resulting from or arising in connection
with any product liability or other claims (other than claims for patent
infringement) arising from the use by any person of such Product in
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such country. Section 3.02 sets forth the Parties' liability obligations
arising from claims for patent infringement.
(e) The aforesaid obligations of the indemnifying Party shall be
subject to the indemnified Party fulfilling the following obligations:
(i) The indemnified Party shall fully cooperate with the indemnifying
Party in the defense of any claims, actions, etc., which defense shall be
controlled by the indemnifying Party.
(ii) The indemnified Party shall not, except at its own cost,
voluntarily make any payment or incur any expense with respect to any claim
or suit without the prior written consent of the indemnifying Party, which
consent such Party shall not be required to give.
(iii) The indemnified Party shall notify the indemnifying Party
promptly after receipt of a notice of the commencement of any litigation or
threat thereof that may reasonably lead to a claim for indemnification.
(f) The Parties agree to maintain appropriate amounts of product
liability insurance coverage and to have the other Party included as an
additional insured on such policies.
Section 7.03 Dispute Resolution. In the event of any controversy or
claim arising out of or relating to any provision of this Agreement or any
term or condition hereof, or the performance by a Party of its obligations
hereunder, the Parties shall try to settle their differences amicably
between themselves. If the representatives of the Parties are unable to
reach agreement on any such issue, the issue shall be submitted for
consideration, in the case of Agouron, to a designee of its Chief Executive
Officer and, in the case of JE, to a designee of its Managing Director of
Pharmaceuticals and Biobusiness Division. If such designees are unable to
agree, then the issue shall be resolved, in the case of Agouron, by its
Chief Executive Officer and, in the case of JE, by its Managing Director of
Pharmaceuticals and Biobusiness Division. Any unresolved issues arising
between the Parties relating to, arising out of, or in any way connected
with this Agreement or any term or condition hereof, or the performance by
a Party of its obligations hereunder, whether before or after termination
of this Agreement, except as otherwise provided in this Agreement, shall be
finally resolved by binding arbitration. Whenever a Party shall decide to
institute arbitration proceedings, it shall give written notice to that
effect to the other Party. The Party giving such notice shall refrain from
instituting the arbitration proceedings for a period of sixty (60) days
following such notice. If JE is the Party initiating the arbitration, the
arbitration shall be held in San Diego, California, according to the rules
of the American Arbitration Association ("AAA"). If Agouron is the Party
initiating the arbitration, the arbitration shall be held in Tokyo, Japan,
according to the rules of the Japan Commercial Arbitration Association
"JCAA"). The arbitration shall be conducted by a single arbitrator
mutually chosen by the Parties. If the Parties cannot agree upon a single
arbitrator within fifteen (15) days after the institution of the
arbitration proceeding, then the arbitration shall be conducted by a panel
of three arbitrators appointed in accordance with applicable AAA or JCAA
39
rules; provided, however, that each Party shall, within thirty (30) days
after the institution of the arbitration proceedings, appoint one
arbitrator with the third arbitrator being chosen by the other two
arbitrators. If only one Party appoints an arbitrator, then such arbitrator
shall be entitled to act as the sole arbitrator to resolve the controversy.
Any arbitration hereunder shall be conducted in the English language, to
the maximum extent possible. All arbitrator(s) eligible to conduct the
arbitration must agree to render their opinion(s) within thirty (30) days
of the final arbitration hearing. The arbitrator(s) shall have the
authority to grant injunctive relief and specific performance and to
allocate between the Parties the costs of arbitration in such equitable
manner as he/she determines; provided, however, that each Party shall bear
its own costs and attorneys' and witness' fees. Notwithstanding the terms
of this Section 7.03, a Party shall also have the right to obtain, prior to
the arbitrator(s) rendering the arbitration decision, provisional remedies,
including injunctive relief or specific performance, from a court having
jurisdiction thereof. The arbitrator(s) shall, upon the request of either
Party, issue a written opinion of the findings of fact and conclusions of
law and shall deliver a copy to each of the Parties. Decisions of the
arbitrator(s) shall be final and binding on all of the Parties. Judgment on
the award so rendered may be entered in any court having jurisdiction
thereof.
ARTICLE VIII - DISCLOSURE OF AGREEMENT
Section 8.01 Disclosure of Agreement Except as agreed to by the
Parties, and as required for the performance of its obligations
hereunder, neither JE nor Agouron shall release any information to any
third party with respect to any of the terms of this Agreement without
the prior written consent of the other Party, which consent shall not
unreasonably be withheld. This prohibition includes, but is not
limited to, press releases, educational and scientific conferences,
promotional materials and discussions with the media. The Parties
shall jointly prepare and release a public announcement regarding the
existence of this Agreement. If a Party determines that it is required
by law, including securities laws and regulations pertaining to
publicly traded companies, to release information to any third party
regarding the terms of this Agreement, it shall notify the other Party
of this fact prior to releasing the information. The notice to the
other Party shall include the text of the information proposed for
release. The other Party shall have the right to confer with the
notifying Party regarding the necessity for the disclosure and the
text of the information proposed for release, but the notifying Party
shall have the discretion to release the information as it deems
necessary to fulfill its requirements under law. Notwithstanding the
preceding, JE and Agouron shall each have the right to disclose the
terms of this Agreement to persons it proposes to enter into business
relationships with, if such persons are subject to confidentiality and
use obligations equivalent to those applicable to the disclosing Party
hereunder.
ARTICLE IX - GENERAL PROVISIONS
Section 9.01 No Implied Licenses Only the licenses granted
pursuant to the express terms of this Agreement shall be of any legal
force and effect. No license rights shall be created by implication or
estoppel.
40
Section 9.02 No Waiver Any failure by a Party to enforce any
right which it may have hereunder in any instance shall not be deemed
to waive any right which it or the other Party may have in any other
instance with respect to any provision of this Agreement, including
the provision which such Party has failed to enforce.
Section 9.03 Severability; Government Acts. In the event that any
provision of this Agreement is judicially, or by a competent
authority, determined to be unenforceable, in part or in whole, with
regard to any or all of the countries in the Territory, the remaining
provisions or portions of this Agreement shall be valid and binding to
the fullest extent possible, and the Parties shall endeavor to
negotiate additional terms, as feasible, in a timely manner so as to
fully effectuate the original intent of the Parties, to the extent
possible, in the applicable countries. In the event that any act,
regulation, directive, or law of a country, including its departments,
agencies or courts should make impossible or prohibit, restrain,
modify or limit any material act or obligation of a Party under this
Agreement, and if any Party to this Agreement is materially adversely
affected thereby, the Parties shall attempt in good faith to negotiate
a lawful and enforceable modification to this Agreement that
substantially eliminates the material adverse effect; provided that,
failing any agreement in that regard, the Party who is materially
adversely affected shall have the right, at its option, to suspend or
terminate this Agreement as to such country.
Section 9.04 Ambiguities. Ambiguities, if any, in this Agreement
shall not be construed against any Party, irrespective of which Party
may be deemed to have authored the ambiguous provision.
Section 9.05 Notification and Governmental Approvals. After
execution of this Agreement, to the extent required by law, Agouron,
after consultation with JE, shall notify the appropriate authorities
in the Licensed Territory about the terms of this Agreement; JE, after
consultation with Agouron, shall notify the appropriate authorities in
the JE Territory about the terms of this Agreement. JE and Agouron
shall obtain any government approval(s) required to enable this
Agreement to become effective, or to enable any payment hereunder to
be made, or any other obligation hereunder to be observed or
performed. Third-party costs and expenses incurred in notifying
governmental authorities or obtaining governmental approval shall be
shared equally between the Parties. Each Party shall keep the other
Party informed of its progress in notifying such governmental
authorities and obtaining such government approval, and shall
cooperate with the other Party in any such efforts.
Section 9.06 U.S. Export Controls The Parties agree to comply
with the United States laws and regulations governing exports and
re-exports of the Compound, intermediates thereof, Products,
Development Program Technology, JE Technology or any other technology
or software developed or disclosed as a result of this Agreement. The
Parties acknowledge that any performance under this Agreement is
subject to any restrictions which may be imposed by the United States
laws and regulations governing exports and re-exports. Each Party
agrees to provide the other Party with any reasonable assistance,
including written assurances which may be required by a competent
governmental authority and by applicable laws and regulations as a
precondition for any disclosure of technology or software by the other
Party under the terms of
41
this Agreement. The obligations of this Section 9.06 shall
survive termination or expiration of this Agreement.
Section 9.07 No Agency. JE and Agouron shall have the status of
independent contractors under this Agreement and, except as otherwise
explicitly provided in this Agreement, nothing in this Agreement shall
be construed as an authorization of a Party to act as an agent of the
other Party.
Section 9.08 Captions; Number; Official Language. The captions of
the articles and sections of this Agreement are for general
information and reference only, and this Agreement shall not be
construed by reference to such captions. Where applicable in this
Agreement, the singular includes the plural and vice versa. To the
extent appropriate, the meaning of terms whose first letters are
capitalized, but which are variations of terms that are defined
elsewhere in this Agreement, shall each have the same meaning as the
defined term. English shall be the official language of this Agreement
and any license agreement provided for hereunder, and all
communications between the Parties hereto shall be conducted in that
language.
Section 9.09 Force Majeure. A Party shall not be responsible to
the other Party for any failure, delay or interruption in the
performance of any of its obligations under this Agreement if such
failure, delay or interruption is caused by any act of God,
earthquake, fire, casualty, flood, war, epidemic, riot, insurrection,
or any act, exercise, assertion or requirement of a governmental
authority, or other cause beyond the reasonable control of the Party
affected if the Party affected shall have used its best efforts to
avoid such occurrence. If a Party believes that the performance of any
of its obligations under this Agreement shall be delayed or
interrupted as a result of any of the reasons stated in this Section
9.09, and provided such Party is able to do so, such Party shall
promptly notify the other Party of such delay or interruption and the
cause therefor, and shall provide such other Party with its estimate
of when the performance of its obligations shall recommence. When the
Party affected is able to recommence the performance of obligations
delayed or interrupted as a result of any of the reasons stated in
this Section 9.09, it shall so notify the other Party and, except as
otherwise provided in this Agreement, it shall promptly resume the
performance of such obligations.
Section 9.10 Amendment. This Agreement, including the
Attachments, Exhibits and Schedules, constitutes the full agreement of
the Parties with respect to the subject matter of this Agreement, and
incorporates any prior discussions between them with respect to such
subject matter. This Agreement supersedes the rights and obligations
of JE and Agouron under the Confidential Disclosure Agreement and the
Material Transfer Agreement between the Parties which were both
originally entered into on December 22, 1997. This Agreement,
including the attachments hereto, shall not be amended, supplemented
or otherwise modified, except by an instrument in writing signed by
duly authorized officers of the Parties.
Section 9.11 Applicable Law. This Agreement shall be construed
and the rights of the Parties shall be determined in accordance with
the laws of Japan; provided, however, that with regard to issues
concerning the validity and construction of patents, trademarks and
other
42
intellectual property, the rights of the Parties shall be
determined in accordance with the laws of the country under which such
intellectual property rights were granted.under which such
intellectual property rights were granted.
Section 9.12 Notices. Any notice required or permitted to be
given under this Agreement shall be in writing and shall be given in
person, delivered by recognized overnight delivery service, sent by
mail (certified or registered, or air mail for addresses outside of
the continental U.S.), or by telefax (or other similar means of
electronic communication), whose receipt is confirmed by confirming
telefax, and addressed, in the case of JE, to its Managing Director of
Pharmaceuticals and Biobusiness Division and, in the case of Agouron,
to the Senior Vice President, Commercial Affairs (with a copy to the
Legal Department), at the addresses shown at the beginning of this
Agreement, or such other person and/or address as may have been
furnished in writing to the notifying Party in accordance with the
provisions of this Section 9.12. Except as otherwise provided herein,
any notice shall be deemed delivered upon the earliest of: (i) actual
receipt; (ii) four (4) business days after delivery to such recognized
overnight delivery service; (iii) eight (8) business days after
deposit in the mail; or (iv) the date of receipt of the confirming
telefax.
Section 9.13 Assignment. This Agreement shall be assignable by a
Party to its Affiliates; if this Agreement is assigned by a Party to
an Affiliate, the Party shall still be responsible for all of its
obligations as specified in this Agreement. This Agreement shall only
be assignable by a Party to a non-Affiliated third party with the
prior written consent of the other Party, which consent may be
withheld at the sole discretion of such other Party. Any such
assignment without the prior written consent of the other Party shall
be void. Notwithstanding the preceding, in the event of: (i) a sale or
transfer of all or substantially all of a Party's assets; or (ii) the
merger or consolidation of a Party with another company, this
Agreement shall be assignable to the transferee or successor company.
Section 9.14 Succession. This Agreement shall be binding upon all
successors in interest, assigns, trustees and other legal
representatives of the Parties.
43
IN WITNESS WHEREOF, the Parties hereto have executed this
Agreement at a formal signing ceremony on July 28, 1998, in duplicate
originals, by their respective officers thereunto duly authorized.
JAPAN ENERGY CORPORATION AGOURON PHARMACEUTICALS, INC.
By: /s/ Akihiko Nimoyama By: /s/ Xxxxx Xxxxxxx
Name: Akihiko Nimoyama Name: Xxxxx Xxxxxxx
Title: Representative Director and Title: Chief Executive Officer
President and President
By: /s/ Xxx Xxxxx By: /s/ Xxxx Xxxxxxxx
Name: Xxx Xxxxx Name: Xxxx X. Xxxxxxxx, Esq.
Title: Senior Management Director Title: Corporate V.P. and General Counsel
WITNESSED BY:
By: /s/ Toshinobu Miyake By: /s/ R. Xxxx Xxxxxx
Name: Toshinobu Miyake Name: R. Xxxx Xxxxxx
Title: Assoc. Dir., General Mgr. of Title: Senior Vice President
Coordination Business Development
Pharmaceuticals & Biobusines
Division
44
S1-1
SCHEDULE 1
JE PATENTS AND PATENT APPLICATIONS
*
S1-1
S2-1
SCHEDULE 2
*
S2-1
*
SCHEDULE 7.01(c)
*
S7.01(c)-1
*
EXHIBIT 1
DEVELOPMENT PROGRAM
*
E1-1
ATTACHMENT 1
TRADEMARK LICENSE
*
A1-1
