<PAGE>
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
(Amendment No. 2 to the Form 10-Q Filed January 31, 1995)
(X) QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 1994
OR
( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number 0-15609
AGOURON PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
CALIFORNIA 33-0061928
(State or other jurisdiction of (I.R.S. employer identification no.)
incorporation or organization)
10350 NORTH TORREY PINES ROAD, LA JOLLA, CALIFORNIA 92037-1020
(Address and zip code of principal executive offices)
(619) 622-3000
(Registrant's telephone number, including area code)
NONE
(Former name, former address and former fiscal year,
if changed since last report.)
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that
the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days:
Yes __X__ No ____
Indicate the number of shares outstanding of each of the issuer's classes
of common stock, as of the latest practicable date: Approximately 7,294,000
shares of the Company's Common Stock, no par value, were outstanding as of
January 22, 1995.
<PAGE>
Item 6. Exhibits and Reports on Form 8-K:
a. Exhibits:
10.54 Development and License Agreement dated December 1, 1994
between Japan Tobacco Inc. and the Company (confidential
treatment has been requested for portions of this
agreement pursuant to an application dated January 31,
1995)
10.55 Third Amendment of Agreement One effective January 15,
1995 between Japan Tobacco Inc. and the Company
(confidential treatment has been requested for portions
of this agreement pursuant to an application dated
January 31, 1995)
b. Reports on Form 8-K:
None
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
AGOURON PHARMACEUTICALS, INC.
Date: June 21, 1995 /s/ Steven S. Cowell
-------------------------------------------
Steven S. Cowell
Vice President, Finance and Chief Financial
Officer and Chief Accounting Officer
<PAGE>
Exhibit 10.54
PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED
(DESIGNATED BY AN ASTERIX (*) AND WHITE SPACE)
AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST
FOR CONFIDENTIAL TREATMENT FILED
JANUARY 31, 1995; FILE NO. 0-15609
SEC CONFIDENTIAL DRAFT
DEVELOPMENT AND LICENSE AGREEMENT
BETWEEN
JAPAN TOBACCO INC.
AND
AGOURON PHARMACEUTICALS, INC.
DECEMBER 1, 1994
<PAGE>
INDEX TO ARTICLES
Page No.
BACKGROUND
ARTICLE I Definitions
Section 1.01 Affiliate
Section 1.02 Agouron Exclusive Territories
Section 1.03 *
Section 1.04 *
Section 1.05 *
Section 1.06 Combination Product
Section 1.07 Compound
Section 1.08 Control or Controlled
Section 1.09 Development Program
Section 1.10 *
Section 1.11 *
Section 1.12 Dossier
Section 1.13 Effective Date
Section 1.14 Global Joint Development Committee
Section 1.15 Global Joint Marketing Committee
Section 1.16 Japan
Section 1.17 Joint Venture
Section 1.18 *
Section 1.19 *
Section 1.20 *
Section 1.21 *
Section 1.22 Major Market Countries
Section 1.23 Marketing Company
Section 1.24 Net Sales
Section 1.25 Patent Rights
Section 1.26 Product
Section 1.27 "Profit(s) .
Section 1.28 Registration
Section 1.29 *
Section 1.30 *
Section 1.31 *
Section 1.32 *
Section 1.33 Territory
Section 1.34 Trademark(s)
Section 1.35 United States
ARTICLE II Commercial Rights
Section 2.01 License Grants
Section 2.02 Diligent Efforts to Market
Section 2.03 Discontinuance of the Development Program
<PAGE>
INDEX TO ARTICLES
Continued
Page No.
ARTICLE III Sharing and Protection of Intellectual Property
Section 3.01 Patents
Section 3.02 Infringement of Patents of Third Parties
Section 3.03 Trademarks
Section 3.04 Information Exchange
Section 3.05 Confidentiality
Section 3.06 Publication
ARTICLE IV Management Structure of Collaboration
Section 4.01 Management Committees
Section 4.02 Development and Registration
Section 4.03 Marketing
Section 4.04 Supply of Compound and Product
ARTICLE V Payments, Development Costs; Premarketing
Expenses and Profit Sharing
Section 5.01 Payments
Section 5.02 Development Costs
Section 5.03 Premarketing Expenses
Section 5.04 Profit
Section 5.05 General Licensing Terms
ARTICLE VI Research Program
Section 6.01 Scope and Conduct of Research Program
ARTICLE VII Term and Termination
Section 7.01 Termination for Breach
Section 7.02 Termination by Mutual Agreement
Section 7.03 Termination Upon Bankruptcy
Section 7.04 Disposition of Inventory
Section 7.05 Effect of Termination
ARTICLE VIII Warranties, Covenants; Indemnities; Dispute
Resolution; Governmental Approvals; Export
Controls
Section 8.01 Warranties, Covenants
Section 8.02 Indemnities; Insurance
Section 8.03 Dispute Resolution
Section 8.04 Government Approvals
Section 8.05 Export Controls
ARTICLE IX Disclosure of Agreement
Section 9.01 Disclosure of Agreement
<PAGE>
INDEX TO ARTICLES
Continued
Page No.
ARTICLE X General Provisions
Section 10.01 No Implied Licenses
Section 10.02 No Waiver
Section 10.03 Severability; Ambiguities
Section 10.04 Government Acts
Section 10.05 Notification of Authorities
Section 10.06 No Agency
Section 10.07 Captions; Number; Official Language
Section 10.08 Force Majeure
Section 10.09 Amendment
Section 10.10 Applicable Law
Section 10.11 Notices
Section 10.12 Succession
APPENDICES
SCHEDULE 1 *
SCHEDULE 2 *
SCHEDULE 3 *
SCHEDULE 4 *
EXHIBIT 1 *
EXHIBIT 2A Estimate Budget *
EXHIBIT 2B Estimated Budget *
EXHIBIT 3 *
ATTACHMENT 1 *
ATTACHMENT 2 *
ATTACHMENT 3 * Specifications
ATTACHMENT 4 * Terms/Definitions
ATTACHMENT 5 * Procedures
ATTACHMENT 6 *
Procedures
ATTACHMENT 7 * Terms and Conditions
<PAGE>
This Development and License Agreement ("Agreement"), dated for
reference purposes only this 1st day of December 1994, by and between Agouron
Pharmaceuticals, Inc. ("Agouron"), a California corporation with offices at
10350 North Torrey Pines Road, La Jolla, California, United States of America
and Japan Tobacco Inc. ("JT"), a Japanese corporation with offices at 12-62,
Higashi-Shinagawa 4 chome, Shinagawa-ku, Tokyo 140, Japan. Agouron and JT
are sometimes hereinafter referred to as a party (collectively "parties") to
this Agreement.
BACKGROUND
Agouron and JT are interested in collaborating in the development and
commercialization of the chemical compound known as AG1343. When the AG1343
collaboration has commenced Stage 3 as described below and JT has made the
provided for $24 million milestone payment to Agouron, *
NOW THEREFORE, in consideration of the premises and mutual covenants and
exchange of other considerations set forth herein, the parties agree as
follows:
ARTICLE I
Definitions
When used in this Agreement, each of the following terms shall have the
meaning set out in this Article I. All references to Articles, Attachments,
Sections, Schedules, Exhibits and Appendices shall refer to the Articles,
Attachments, Sections, Schedules, Exhibits and Appendices of this Agreement,
all of which are incorporated herein by reference.
Section 1.01 "Affiliate" means any person, organization or entity
which is, directly or indirectly, controlling, controlled by, or under common
control with JT 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 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 a person, organization or
entity. Notwithstanding the preceding, the government of Japan shall not be
considered to be an Affiliate of JT.
Section 1.02 "Agouron Exclusive Territories" means the United
States of America, Canada, and Mexico.
Section 1.03 * means (i) the patents and the
patent applications * that are referred to in *
(ii) all patents arising from said applications and
all patents and patent applications based upon or claiming *
or (iii) *
<PAGE>
Section 1.04 * means any know-how, trade secret,
experimental data, formula, expert opinion, experimental procedure and other
confidential and/or proprietary information specifically concerning the *
Section 1.05 * means all of the countries of *
and the * countries listed in *
Section 1.06 "Combination Product" means any pharmaceutical product
in any dosage form which contains, in addition to *
Section 1.07 "Compound" means the chemical compound known as
AG1343, whose chemical name is as follows:
[3S-(3R*, 4aR*, 8aR*, 2'S*, 3'S*)]-2-[2'-hydroxy-3'-phenylthiomethyl-
4'-aza-5'-oxo-5'-(2''-methyl-3''-hydroxyphenyl)pentyl]-
decahydroisoquinoline-3-N-t-butyl carboxamide methanesulfonic acid
salt
and whose chemical structure is as follows:
[CHEMICAL STRUCTURE WOULD NOT CONVERT TO ASCII -- SEE CHEMICAL
NAME ABOVE FOR A DESCRIPTION OF THE CHEMICAL STRUCTURE]
Section 1.08 "Control" or "Controlled".means *
without violating the terms of any
agreement with, or arrangement with, or the rights of any third party.
Section 1.09 "Development Program".means all normal and customary
activities necessary for the timely development of *
including but not limited to *
Section 1.10 * are limited to those
*
made in the *
(a) being contained in *
<PAGE>
and
(b) *
Section 1.11 * means any know-how,
trade secret, experimental data, formula, expert opinion, experimental
procedure and other confidential and/or proprietary information
specifically concerning the *
which is necessary either (i) for *
or (ii) for *
Section 1.12 "Dossier" means the document which is filed with and
approved by a government or health authority for purposes of Registration,
for example, a New Drug Application or a Marketing Authorization Application.
Section 1.13 "Effective Date" means *
Section 1.14 "Global Joint Development Committee" has the meaning
assigned in Section 4.01(b)(i).
Section 1.15 "Global Joint Marketing Committee" has the meaning
assigned in Section 4.01(b)(ii).
Section 1.16 "Japan" means Japan, its territories, possessions and
protectorates.
Section 1.17 "Joint Venture" means the joint venture to be formed
by the parties pursuant to the terms of Section 2.01 of this Agreement.
Section 1.18 "Joint Venture Exclusive Territories" means all
countries of the world, except those countries comprising the Agouron
Exclusive Territories and the JT Exclusive Territories.
Section 1.19 "JT Exclusive Territories" means Japan and the other
countries of Asia listed in *
Section 1.20 * means any know-how, trade secret,
experimental data, formula, expert opinion, experimental procedure and other
confidential and/or proprietary information specifically concerning the *
which was developed or acquired by
or on behalf of *
which is necessary either *
<PAGE>
Section 1.21 *
Section 1.22 "Major Market Countries" means the countries listed in
Schedule 3 attached to this Agreement.
Section 1.23 "Marketing Company" means the company marketing the
Product in a specific country.
Section 1.24 "Net Sales" means the gross invoiced sales prices of
Products, whether in active ingredient form or finished product form,
realized by either party, their Affiliates and sublicensees from sales to
non-Affiliated third party purchasers, less, to the extent such amounts are
included in the invoiced sales price, taxes, shipping costs (including
freight and insurance), and duties and other governmental charges paid for
and separately identified on the invoice. Additional allowances will be
permitted for (i) cash, trade and/or quantity discounts actually allowed;
(ii) amounts repaid or credited by reason of rejection or return of goods;
(iii) volume or formulary discount amounts paid or credited to a wholesaler,
purchaser, third party payor or other contractee as a result of a contractual
arrangement specific to a Product; (iv) rebates paid or credited to any
government or agency (or branch thereof) or to any third party payor,
administrator or contractee; and (v) discounts mandated by, or granted in
response to applicable state, provincial or federal law, wholesaler
chargebacks or retroactive price reductions. Net Sales shall not be reduced
for any reserves or allowances for bad debts. A sale of a Product is deemed
to occur upon the earliest of invoicing or transfer of title in the Product
to non-Affiliated third party purchasers.
Section 1.25 "Patent Rights" means *
Section 1.26 * any pharmaceutical product in an *
or in a * which contains the *
provided that such *
including, without limitation, *
Section 1.27 "Profit(s)" shall have the meaning which will be set
forth in Attachment 4.
Section 1.28 "Registration" means the official approval by the
government or health authority in each country of the Territory which is
required for a Product to be offered for sale in the country concerned,
including such authorizations as may be required for the production,
importation, pricing and sale of such Product.
Section 1.29 *
has the meaning described in * The beginning date of *
Section 1.30 *
has the meaning described in * The beginning date of * is
the date described in *
Section 1.31 *
has the meaning described in * The beginning date of * is the
date described in *
<PAGE>
Section 1.32 *
has the meaning described in * The beginning date of * is the
date described in *
Section 1.33 "Territory" means the world.
Section 1.34 "Trademark(s)" means any trademark selected and owned
by a party and registered by such party, its Affiliate(s) and sublicensee(s)
in the Territory for use in connection with the marketing of Products.
Section 1.35 "United States" means the United States of America,
its territories, possessions and protectorates.
ARTICLE II
Commercial Rights
Section 2.01 License Grants. To implement the commercialization of
the Compound and/or Products arising out of the Development Program, the
parties, as provided below in this Article II, will license the Compound
and/or Products arising out of the Development Program to *
(a) Subject to the provisions of Sections 2.01(d) and 2.01(e),
JT shall have the exclusive right (with right of sublicense) to use, offer
for sale, sell and import in or into the JT Exclusive Territories *
(b) Subject to the provisions of Sections 2.01(d) and 2.01(e),
Agouron shall have the exclusive right (with right of sublicense) to use,
offer for sale, sell and import in or into the Agouron Exclusive Territories
*
(c) The Joint Venture shall have the exclusive right (with
right of sublicense) to use, offer for sale, sell and import in or into the
Joint Venture Exclusive Territories *
(d) Each party and the Joint Venture shall have the non-
exclusive right (with right of sublicense) to make and/or have made anywhere
in the *
so as to permit the use, offer
for sale, sale and import by each party and/or the Joint Venture of the *
(e) A party wishing to sublicense the *
shall give
the other party notice of its intent to sublicense *
by providing the other party with a summary of the proposed license terms and
<PAGE>
the name of the proposed sublicensee(s). If prior to the expiration of *
the other party does not elect to enter into
a sublicense for *
the notifying party, *
shall have the right
to enter into a sublicense *
on terms which are substantially similar to those stated in the summary of
the proposed license terms. If a sublicense agreement with a proposed
sublicensee(s) on terms which are substantially similar to those stated in
the summary of the proposed license terms is not entered into *
then the party wishing to sublicense the * must
again comply with all of the terms of this Section, including the giving of a
new sublicense notice and the expiration of a *
(f) Notwithstanding the terms of * each party shall
have a paid-up, royalty-free non-exclusive right to use *
in the Territory.
(g) Except as otherwise provided in this Agreement, each party
shall have a perpetual paid-up, royalty-free non-exclusive right (with
right of sublicense) *
in the Territory.
(h) If a party or the Joint Venture wishes to receive a *
then the parties and/or the Joint Venture shall enter into good faith
negotiations with regard to the terms of * If a party or the
Joint Venture wishes to receive *
then the parties and/or the Joint
Venture shall discuss the terms of *
(i) *
The development
and commercialization terms of the * will be
substantially similar to those contained in this Agreement; provided however
that the * described in Sections *
after the end of * will be funded by the parties
as provided elsewhere in this Agreement. *
(j) Notwithstanding anything to the contrary contained in this
Agreement, each of the parties agrees not to sell the Compound and/or
Products for other than human pharmaceutical uses without the written
agreement of the other party.
<PAGE>
(k) Each party hereby grants to the other party, its Affiliates
and sublicensees, and the Joint Venture a non-exclusive right to use the
granting party's *
Notwithstanding the preceding: *
each party hereby grants
to the Joint Venture and its sublicensees the *
Section 2.02 Diligent Efforts to Market. The parties agree that
the party having the exclusive license on a Product in a country shall begin
commercial sales of at least one Product arising out of the Development
Program in the country no later than one (1) year after the Registration and,
if appropriate, final pricing approval is obtained for such sales in such
country, provided that such period shall be extended for as long as diligent
efforts to begin commercial sales continue. Such party agrees to use
diligent efforts to market which are comparable to efforts it uses with other
products of similar status. For purposes of this Section 2.02,
commercialization efforts undertaken by a party's Affiliates and sublicensees
shall be attributed to the party. If after sixty (60) days written notice of
a failure to begin commercial sales for at least one such Product in a
country in a timely manner, the party having the exclusive license on the
Product in the country fails to fulfill its obligation under this Section
2.02 and, notwithstanding anything to the contrary contained in Sections
2.01(a) or 2.01(b), the other party shall have the right, as the sole and
exclusive remedy for such failure, to elect to have the license granted to
the party having the exclusive license on the Product in such country under
the terms of Sections 2.01(a) or 2.01(b) canceled and converted to a license
to the Joint Venture pursuant to the terms of Section 2.01(c). The Joint
Venture under such license shall have the exclusive right (with right of
sublicense) to use, offer for sale, sell and import in or into such country
the Product under applicable Agouron Patent Rights and Development Program
Patent Rights and using applicable Agouron Technology, JT Technology and
Development Program Technology; for purposes of this license any use, offer
for sale, sale and import of the Product in such country will be deemed to
have occurred in or into Joint Venture Exclusive Territories. No additional
consideration shall be due because of the exercise of such election.
Section 2.03 Discontinuance of the Development Program. *
In the event of the discontinuation of the *
pursuant to the terms of *
* Additionally, in such event, * shall not
have any right to receive *
<PAGE>
shall be deemed to have made a timely election
to discontinue the *
ARTICLE III
Sharing and Protection of Intellectual Property
Section 3.01 Patents.
(a) As long as any of the parties have *
parties, unless they agree otherwise, agree to prepare, file, prosecute and
maintain patent applications and patents containing *
(i) The parties agree to jointly determine the most
appropriate manner to file the patents to protect the commercial
interests of the parties in the *
(ii) Notwithstanding the preceding, JT and Agouron shall
each be entitled to *
provided, however, that a party not otherwise *
(b) The parties agree that while *
(c) Prior to filing any patent application, the filing party
will provide the other party with *
The filing party will also provide the non-filing party with a *
It is
the intent of the parties that any patent issuing to the parties hereunder
shall be of the *
(d) Each of the parties will require its respective employees
to (i) assign all of their rights and ownership in *
and (ii) to assist (without further compensation (except for
reimbursement for reasonable and necessary expenses)) a requesting party in
preparing and prosecuting the application for patents throughout the *
<PAGE>
(e) Unless the parties agree otherwise, *
The
parties shall jointly determine the most appropriate manner to prepare,
file, prosecute and maintain *
Each party, as an undivided joint owner of such compound,
shall have the *
(f) Each party shall promptly notify the other of its knowledge
of any potential infringement of the Patent Rights by a third party. The
parties agree to cooperate in taking commercially reasonable legal actions to
protect the commercial interests of the parties in the *
against infringement by third parties in all countries.
If within * following receipt of written notice requesting a
party to join in an action to protect against such infringement by third
parties, a party fails to participate in such commercially reasonable action
by the other party to halt an alleged infringement, the other party shall, *
If both parties wish to
participate in taking action to protect the commercial interests of the
parties in the *
Each party
agrees to render such reasonable assistance as the prosecuting party may
request. If the parties are unable to agree whether it is commercially
reasonable to pursue a third party infringer or other issue concerning the
action, then *
Section 3.02 Infringement of Patents of Third Parties. Each party
shall use its diligent efforts to avoid infringement of patents of any third
party in discovering, developing, manufacturing and commercializing the
Compound or Products. However, neither party shall be liable to the other
party if the Compound, intermediates thereof or Products infringe any patent
of any third party. If either party becomes aware of any claim or suit by
any third party for infringement of a patent of such third party in
connection with the discovery, development, manufacture, use or sale of the
Compound or Products by a party hereto, such party shall notify the other
party in writing of such claim or suit within thirty (30) days thereafter.
Each party agrees to render such reasonable assistance as the other party may
request in defending any such claim or suit. The parties shall mutually
agree to any settlement of any infringement claim or action that would
require the payment of any royalty to a third party, except that if the
parties cannot promptly reach agreement they shall appoint an independent
patent counsel to give an opinion, which will be binding on the parties, as
to whether the third party patent is valid and, if so, whether it is
infringed. If the opinion is that the patent is valid and infringed, the
developing/marketing party, after consultation with the other party, may
settle the matter in its sole discretion on such terms as it deems
appropriate. If both parties are participating in the development or
marketing, the parties shall mutually agree to any settlement of any
infringement claim or action that would require the payment of any royalty to
a third party; if the parties are unable to mutually agree on the settlement,
then the issue shall be decided by binding arbitration in accordance with the
provisions of Section 8.03
<PAGE>
hereof. Unless the parties agree otherwise, the costs of defending or
settling any such claim or action in the Joint Venture Exclusive Territories
shall be borne by the Joint Venture; costs of defending or settling any such
claim or action in the JT and Agouron Exclusive Territories shall be a
deductible expense when calculating Profits.
Section 3.03 Trademarks. Either party, its Affiliates and
sublicensees, if any, shall be free to use and to register in any
trademark office in the * any Trademark for use *
Notwithstanding the preceding, it is the intent of the
parties that a single Trademark be identified and developed for use in
marketing a * wherever possible throughout the *
The parties agree to *
and
to cooperate with each other in reasonable efforts to protect the rights of
the parties in a Trademark, including notification of any infringement which
may come to a party's attention and the proper execution and filing of
appropriate registered user documents. *
Section 3.04 Information Exchange.
(a) Upon execution of this Agreement, and thereafter on an
ongoing basis *
each party shall provide *
Notwithstanding the foregoing, neither party shall be obligated to disclose
to the other any information that it is prohibited from disclosing to the
other, either by reason of a contract with a third party or by law. In the
event of such a restriction, the parties shall cooperate and take such
legally permissible action as may be reasonable to permit such disclosure to
be made.
(b) Each of the parties shall * prepare a list
which reflects, to the best of its knowledge, the current status of any *
which list shall be submitted to the other party *
The parties, if they so
elect, may mutually prepare a joint list to satisfy the preceding
obligations.
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, JT and Agouron shall
keep in confidence and shall each use its best efforts to cause its
respective Affiliates, employees, directors, agents, consultants, outside
contractors, clinical investigators and sublicensees, to whom it is permitted
to disclose information pursuant to the terms of this Agreement, to retain in
<PAGE>
confidence all confidential and proprietary information of the other
party, including *
and/or the
marketing and business plans of such other party and the Joint Venture, which
is disclosed to it hereunder. Without limiting the foregoing, JT 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 that it
maintains policies and procedures designed to prevent the unauthorized
disclosure of its proprietary data and information. JT and Agouron shall be
entitled to disclose the above-described information to consultants, outside
contractors, clinical investigators and other third parties who are subject
to confidentiality and use obligations equivalent to those applicable to the
disclosing party hereunder, and to governmental or other regulatory and/or
health authorities to the extent that such disclosure is reasonably necessary
to obtain patents, to obtain authorization or to conduct clinical trials on
the Compound or Products, to prepare the Dossier and/or otherwise to fulfill
its obligations pursuant to this Agreement. The preceding obligations of
confidentiality shall be waived as to information which the party claiming
waiver can demonstrate, based on written records: (i) is 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 and
competitive 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 application or to comply with applicable laws and regulations.
The obligations under this Section 3.05 shall survive to the
later of (i) *
after the end of the Development Program or (ii) the termination or
expiration date of the last to expire of any license(s) granted pursuant to
this Agreement, to the extent the Development Program Technology, Agouron
Technology or JT Technology is applicable to the practice of grants under
such license(s) or (iii) the expiration date of the last to expire of any
patent(s) within the Patent Rights on a Product.
Section 3.06 Publication. Agouron and JT each acknowledge the
other party's interest in publishing certain of its results of the
Development Program to obtain recognition within the scientific community and
to advance the state of scientific knowledge. Both parties also recognize
their mutual interests in obtaining valid patent protection for the Compound,
intermediates thereof and Products. Consequently, either party, its
employees or consultants wishing to make a publication shall provide the
other party the opportunity to review the proposed manuscript at least thirty
(30) days prior to the date of the intended submission for publication and,
upon either party's written request, shall delay submission for a period (not
greater than forty-five (45) days from the date of such written request)
sufficient to provide for the filing of appropriate patent application(s) for
any patentable subject matter disclosed in such publication.
<PAGE>
ARTICLE IV
Management Structure of Collaboration
Section 4.01 Management Committees.
(a) The collaborative development and commercialization effort
for the *
shall be coordinated and
overseen by a *
shall meet as necessary. The meeting *
The host party shall promptly distribute
meeting minutes to the other party. Each party shall *
(b) *
(i) *
(ii) *
* Both parties shall appoint *
authorized representatives *
and shall notify
the other party as to the name of the individuals so appointed. Each party
may replace its representatives at any time upon written notice to the other
party.
(c) *
<PAGE>
Section 4.02 Development and Registration. JT and Agouron
acknowledge their mutual intention generally to take a collaborative
commercially reasonable approach to the timely development of the Compound
and Products arising out of the Development Program, to the extent possible.
The parties further acknowledge their mutual willingness to discuss ad hoc
agreements to establish appropriate mechanisms for such collaborative
development. Recognizing the importance of timely initiation of development
activities, however, JT and Agouron agree to the following basic approach to
development.
(a) * will be formed *
shall be responsible for the *
(b) * shall meet in regular
intervals, at least * and shall, if necessary *
shall have the authority to make *
regarding: *
shall have the authority to *
or at other sites as
agreed to by the parties. The host party shall promptly distribute meeting
minutes to the other party. *
(c) *
Before the commencement of the *
shall agree upon the *
and other such activities to be conducted in *
shall review
and discuss any *
The parties acknowledge that
while the *
are designed to * that
it will be necessary to *
To the
extent possible, the *
Specific information which is required to *
<PAGE>
Each party shall be
entitled to *
If the parties agree, an *
(d) * will have full
responsibility * agrees to conduct in
good faith all activities necessary to *
All aspects of *
will be determined by *
During this period, *
will have the
opportunity to provide its *
(e) Notwithstanding the preceding, after * is completed,
implementation of *
responsibility to take such
actions as they deem necessary to *
including without limitation, *
In the *
the parties will *
To the extent
possible,*
(f) JT and Agouron shall use reasonable diligence in the
development and Registration of a Product pursuant to the Development
Program. Reasonable diligence shall mean the comparable standard of effort
used by JT and Agouron, respectively, in the development and Registration of
their own major products.
(g) JT and Agouron shall each use qualified persons in the
development activities of the Development Program. Agouron and JT may also
engage consultants, collaborators, clinical investigators and other research
institutions, as may be necessary or desirable, to assist them in carrying
out their responsibilities under the Development Program.
(h) JT and Agouron, * shall
keep each other informed of the progress of the work being performed by them
pursuant to the * This shall include progress reports
as required by the *
Agouron
and JT shall provide each other with such access to each other's *
<PAGE>
(i) All work in connection with the development of the 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.
(j) Each party agrees to use diligent efforts in conducting its
development activities and in responding in a timely manner, but not more
than * to requests from the other party for
preclinical and clinical results and other information concerning the
Development Program to enable the other party to comply with regulatory
requirements for the Development Program.
(k) * for making
application to the World Health Organization International Non-proprietary
Name Committee and the U.S. Adopted Names Council to secure a generic name
for the Compound.
(l) *
Section 4.03 Marketing.
(a) *
(b) It is the intent of the parties that a single Trademark
shall be identified and developed for use on and in connection with *
wherever possible throughout the *
(c) * shall be responsible for
drafting a *
which shall, among other things, establish a *
shall also be responsible for *
(d) * shall meet in regular
intervals, *
to discuss issues related to the *
and shall, if necessary, *
The host
party shall promptly distribute meeting minutes to the other party. Each
party shall *
<PAGE>
(e) * in each country shall be
responsible for establishing *
(f) Unless prohibited by law or regulation, the *
(g) The Marketing Company shall have the right and
responsibility with respect to responding to inquiries and adverse drug
reactions relating to the Product. It is understood that the Marketing
Company is ultimately responsible for the professional services and health
authority communications relating to the Product. Agouron and JT agree that
they shall refer any severe, serious, alarming or unexpected complaints which
they receive, whether or not determined to be attributable to the Product, to
the other party within twenty-four (24) hours by telephone, and in writing
within three (3) business days of receipt of complaint. All other complaints
shall be forwarded to the other party within thirty (30) calendar days of
receipt of complaint. Both Agouron and JT shall respond to routine medical
questions or inquiries directed to them. Within a reasonable time from the
effective date of this Agreement, the parties shall provide each other with
all reasonably necessary information which would enable them to respond
properly and promptly to any such questions or inquiries. The parties shall
use their best efforts to keep such information current. The parties shall
confer with respect to responses to anticipated inquiries and questions.
Section 4.04 Supply of Compound and Product.
(a) It is anticipated that timely development of the Compound
and/or a Product will require the manufacture of *
As part of the *
will also continue *
shall be responsible for *
after the beginning of *
shall be treated as *
To the extent possible, * will make available its *
The parties agree to *
provided however, that if the *
(b) All Product is to be manufactured in accordance with the
specifications to be *
<PAGE>
(c) Each party will grant the other party *
and will take all such other steps as may be reasonably requested
by *
in compliance with the *
(d) In the event any Product delivered hereunder must be
recalled because of action by the relevant health authority, the parties
shall cooperate fully with each other in conducting such recall to the full
extent necessary to ensure that the recall is effective.
ARTICLE V
Payments, Development Costs; Premarketing
Expenses and Profit Sharing
All of the accounting terms used in this Article V, if identified by the
use of capitalization of the first letter of each word, shall have the
meaning expressed in Attachment 4, to be developed during the term of this
Agreement and attached hereto, which shall also contain details of the
calculation, accounting and splitting of the Profits.
Section 5.01 Payments.
(a) * On October 3, 1994, JT paid Agouron the non-refundable
sum of Two Million Five Hundred Thousand U.S. Dollars (U.S. $2,500,000.00) *
(b) *
(c) *
(i) *
(ii) *
As described below, *
(d) *
(e) *
<PAGE>
(f) *
Section 5.02 Development Costs.
(a) The parties shall *
incurred in the implementation of the *
The parties must *
The budget decision in a *
If the parties are
unable to agree *
(b) *
If a
party *
of such * shall be *
if any, from *
Notwithstanding the preceding * shall not be *
The above * shall not be a *
(c) Development Costs shall be the *
The calculation of Development Costs shall take into consideration
the following:
(i) * shall include, but not be
limited to, *
(ii) *
Such costs shall include, but not be limited to, *
To the extent that these *
the associated costs shall be *
(iii) * shall be allocated to
*
Such costs shall include, but not be limited to, *
<PAGE>
A report of Development Costs shall be prepared showing Development Costs *
consistent with accounting classifications and methods agreed
upon by the parties. The accounting report shall be *
The calculation of Development Costs shall not include *
(d) The parties will establish a process for *
Each party shall * Development Costs (including
*
for which it has received a
proper estimate *
taking into account the *
(e) Each party shall maintain books of account and adequate
records of *
(f) Additional details relating to *
such Development Costs *
expressed as *
Section 5.03 Premarketing Expenses. *
Section 5.04 Profit. In partial consideration for the rights
granted each of the parties in this Agreement, the parties agree as follows:
(a) The parties shall *
expenses are
to be determined in accordance with the *
(b) Except as the parties otherwise agree, the parties shall *
pursuant to the terms of *
<PAGE>
expenses are to be determined in
accordance with the *
(c) *
Section 5.05 General Licensing Terms.
(a) A party owing a payment to the other party shall be
entitled to *
JT and Agouron shall advise
each other and provide copies of tax receipts for all taxes on profits,
whether or not deductible from payments of profits. *
(b) With respect to * shall
refer to the sales price of *
(c) * shall be
made on *
from the * by a
party, its Affiliate or sublicensee or the *
(d) *
(e) It is the intent of the parties that sales of a Product
made in each country of the * shall be recorded on the books and
ledgers of the *
(f) The parties agree in the future to use their reasonable
efforts to negotiate any additional licensing terms for the Compound and/or
Product which may be necessary to clarify the rights and obligations of the
parties.
<PAGE>
ARTICLE VI
Research Program
Section 6.01 Scope and Conduct of Research Program. Commencing
within a * after the beginning of *
the parties will *
Efforts will be made to *
Subject to the parties' mutual
agreement * the terms and conditions under which *
ARTICLE VII
Term and Termination
Section 7.01 Termination for Breach. Either party may, at its
option, terminate this Agreement for cause in the event the other party shall
commit a material breach of this Agreement and shall fail to cure such breach
during the * period (*
period in the case of any payment default) following receipt of a written
notice of such breach from the non-breaching party. After the end of the
applicable cure period, the party who has the right of termination may
exercise its termination option by giving the breaching party written notice
of at least fifteen (15) days of its election to terminate. Any termination
of this Agreement shall not release the breaching party from any obligations
incurred hereunder.
Section 7.02 Termination by Mutual Agreement. The parties may at
any time terminate this Agreement, in part or in its entirety, by mutual
written agreement.
Section 7.03 Termination Upon Bankruptcy. In the event that a party
is subject to any proceeding under the bankruptcy laws or to the appointment
of a receiver, trustee or liquidator of its business or substantially all of
its assets, and such proceeding, if involuntary, is not dismissed or
discharged within *
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 of at
least fifteen (15) days in writing to that party from the party who is not
bankrupt or insolvent.
Section 7.04 Disposition of Inventory. In the event of the
cancellation or termination of any license rights with respect to a Product
prior to the expiration of this Agreement, inventory of such Product may be
sold for up to six (6) months after date of termination, provided required
payments, if any, are paid thereon.
Section 7.05 Effect of Termination. The termination of this
Agreement shall, to the extent not otherwise expressly provided herein, not
affect the rights and obligations of the parties under this Agreement with
<PAGE>
respect to (i) the parties' obligations of confidentiality and (ii) the
rights or obligations of the parties otherwise expressly stated in the
Agreement to survive the termination of this Agreement. Upon any termination
of this Agreement in its entirety because of a breach of the other party,
neither party waives any rights to any remedies it may have arising out of
the termination. In the event of any breach by a party with respect to
obligations which continue after a termination in its entirety of this
Agreement, the non-breaching party shall have all remedies available to it as
if the Agreement were still in effect on the date of such breach.
ARTICLE VIII
Warranties, Covenants; Indemnities; Dispute Resolution;
Governmental Approvals; Export Controls
Section 8.01 Warranties, 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.
(b) Agouron represents and warrants that as of the date of the
execution of this Agreement the results of the initial in vitro and
toxicology testing and human clinical study results on AG1343 have been
accurately and correctly disclosed to JT and that, to Agouron's best
knowledge, there is no data or information existing which contradicts,
conflicts or otherwise indicates doubt as to the accuracy or correctness of
such testing and results.
(c) Agouron represents and warrants that as of the date of the
execution of this Agreement to the best of its knowledge (including any
information from its outside patent counsel), it is not aware of (i) any
claims by third parties that the practice of the Agouron Patent Rights would
infringe such third parties patent rights or (ii) any publication which would
render the Agouron Patent Rights unpatentable.
(d) Each party represents and warrants that, as of the date of
the execution of this Agreement, it is not a party to any agreement,
arrangement or understanding with any third party, including agreements with
Eli Lilly and Company, which in any way prevents such party from fulfilling
any of its material obligations under the terms of this Agreement, including
the attachments hereto.
(e) Each party covenants that it will not commit any act or
fail to take any action which 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 and local 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
<PAGE>
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER
DEFINED BY THE CLAIMS OF THE PATENT RIGHTS, INCLUDING THE COMPOUND. THE
PARTIES UNDERSTAND AND AGREE THAT DEVELOPMENT AND COMMERCIALIZATION OF THE
COMPOUND AND/OR PRODUCT(S) WILL INVOLVE APPROVAL BY REGULATORY AUTHORITIES
AND THAT NO PARTY IS GUARANTEEING THE SAFETY OR EFFICACY OF THE COMPOUND
AND/OR PRODUCT(S).
Section 8.02 Indemnities; Insurance.
(a) JT will indemnify and hold harmless Agouron and its
Affiliates, employees, officers, directors, shareholders and agents (an
"Agouron Indemnified Party") from and against any and all liabilities,
losses, damages, costs, or expenses (including reasonable investigative and
attorneys' fees) which 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 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 JT, its Affiliates or
sublicensees, or their respective employees and agents, or on account of JT's
failure to fulfill any obligation or undertaking under this Agreement.
(b) Agouron will indemnify and hold harmless JT and its
Affiliates, employees, officers, directors, shareholders and agents (a "JT
Indemnified Party") from and against any and all liabilities, losses,
damages, costs, or expenses (including reasonable investigative and
attorneys' fees) which the JT Indemnified Party may incur, suffer or be
required to pay, resulting from or arising in connection with any product
liability or other claims 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 any obligation or undertaking under this
Agreement.
(c) To the extent that a product liability or other claim
results from the negligent, reckless or intentional misconduct of both of the
parties, 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 8.02 relating to or involving the
Product: (i) in the * shall
be borne by the Joint Venture; and (ii) in the *
the Marketing Company, except as provided by the terms of Sections 8.02(a),
(b) and (c), shall be responsible for such liabilities, losses, damages,
costs, or expenses and shall indemnify the non-Marketing Company from and
against any and all liabilities, losses, damages, costs, or expenses
(including reasonable investigative and attorneys' fees) which the non-
Marketing Company may incur, suffer or be required to pay, resulting from or
arising in connection with any product liability or other claims arising from
the use by any person of any Product. Any payments made by the Marketing
<PAGE>
Company pursuant to the terms of this Section 8.02(d) shall be a deductible
expense when calculating Profits.
(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; and
(iii) promptly after receipt by the indemnified party
of notice of the commencement of any litigation or threat thereof
which relates to or involves the Product, such party shall notify
the indemnifying party.
(f) The parties and the Joint Venture agree to maintain
appropriate amounts of product liability insurance coverage.
Section 8.03 Dispute Resolution. In the event of any controversy
or claim arising out of or relating to any provision of this Agreement, the
parties shall try to settle their differences amicably between themselves.
Any unresolved disputes 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 either 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 JT 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 can not agree upon a single arbitrator within fifteen (15) days after
the institution of the arbitration proceeding, then the arbitration will be
conducted by a panel of three arbitrators appointed in accordance with
applicable AAA or JCAA 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
determines; provided, however, that each party shall bear its own costs and
<PAGE>
attorneys and witness' fees. Notwithstanding the terms of this Section 8.03
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) will, 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.
Section 8.04 Government Approvals. JT and Agouron will 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. Each party will keep the other
informed of progress in obtaining any such government approval and will
cooperate with the other party in any such efforts.
Section 8.05 Export Controls. The parties agree to abide by the
United States laws and regulations governing exports and re-exports of the
*
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 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 this Agreement.
The obligations of this Section 8.05 shall survive termination or expiration
of this Agreement.
ARTICLE IX
Disclosure of Agreement
Section 9.01 Disclosure of Agreement. Except as agreed to by the
parties, neither Agouron nor JT 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, 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. If a party determines that it is required by law 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. Notwithstanding the preceding, JT
and Agouron shall 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.
<PAGE>
ARTICLE X
General Provisions
Section 10.01 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.
Section 10.02 No Waiver. Any failure by either 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 10.03 Severability; Ambiguities. In the event that any
provision of this Agreement is judicially determined to be unenforceable, in
part or whole, the remaining provisions or portions thereof 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. 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 10.04 Government Acts. In the event that any act,
regulation, directive, or law of a government within any country in the
Territory, including its departments,
agencies or courts, should make
impossible or prohibit, restrain, modify or limit any material act or
obligation of Agouron or JT under this Agreement, the party, if any, not so
affected shall have the right, at its option, to suspend or terminate this
Agreement as to such country in the Territory or to make such modifications
therein as may be necessary.
Section 10.05 Notification of Authorities. After execution of this
Agreement, to the extent required by law, Agouron, after consultation with
JT, shall notify the appropriate United States and European authorities about
the terms of this Agreement and JT, after consultation with Agouron, shall
notify the appropriate Japanese authorities about the terms of this
Agreement. The parties shall keep each other fully advised of the status and
progress of the notification procedures.
Section 10.06 No Agency. Agouron and JT shall have the status of
independent contractors under this Agreement and nothing in this Agreement
shall be construed as an authorization of either party to act as an agent of
the other.
Section 10.07 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. 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 10.08 Force Majeure. Neither party shall be responsible to
the other party for any failure or delay in performing any of its obligations
under this Agreement if such failure or delay is caused by any at of God,
<PAGE>
earthquake, fire, casualty, flood, war, any act, exercise, assertion or
requirement of governmental authority, epidemic, riot, insurrection, or other
cause beyond the reasonable control of the affected party, if the affected
party shall have used its best efforts to avoid such occurrence. If either
party believes that the performance of any of its obligations under this
Agreement will be delayed as a result of any of the reasons stated in this
Section 10.08, such party shall promptly notify the other party of such delay
and the cause therefor and shall provide such other party with its estimate
of when the performance of its obligations will recommence.
Section 10.09 Amendment. This Agreement, including the attachments,
exhibits, schedules and appendices, 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, including the attachments hereto, shall not be
amended, supplemented or otherwise modified except by an instrument in
writing signed by a duly authorized officer of both parties.
Section 10.10 Applicable Law. This Agreement shall be construed,
and the rights of the parties shall be determined, in accordance with the
laws of the State of California, and the United States without regard to its
conflict of law provisions.
Section 10.11 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
Agouron, to the President and, in the case of JT, to the President 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 10.11. Except as otherwise
provided herein, any notice shall be deemed delivered upon the earlier of
(i) actual receipt, (ii) two (2) business days after delivery to such
overnight express service, (iii) five (5) business days after deposited in
the mail, or (iv) the date of receipt of the confirming telefax.
Section 10.12 Succession. This Agreement shall be binding upon all
successors in interest, assigns, trustees and other legal representatives of
the parties.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement, in
duplicate originals, by their respective officers thereunto duly authorized,
the day and year hereinabove written.
AGOURON PHARMACEUTICALS, INC. JAPAN TOBACCO INC.
By: /S/ Gary E. Friedman By: /S/ Masmichi Nishimoto
Gary E. Friedman, Esq. Masamichi Nishimoto
Title: Vice President & General Counsel Title: Executive Director
Attest: Attest:
<PAGE>
The following pages have been deleted from this document for confidentiality
purposes.
SCHEDULE 1 (1 page deleted listing various countries)
SCHEDULE 2 (1 page deleted listing various countries)
SCHEDULE 3 (1 page deleted listing various countries)
SCHEDULE 4 (1 page deleted listing patent rights)
EXHIBIT 1 (1 page listing schedule)
EXHIBIT 2A (2 pages deleted listing budget)
EXHIBIT 2B (2 pages deleted listing budget)
EXHIBIT 3 (5 pages deleted describing schedule of events)
ATTACHMENT 1 (1 page deleted which will describe the terms
of the joint venture)
ATTACHMENT 2 (1 page deleted which will describe the terms
of the trademark license)
ATTACHMENT 3 (1 page deleted which will describe the terms
of the product manufacturing specifications)
ATTACHMENT 4 (1 page deleted which will describe the
accounting terms and definitions)
ATTACHMENT 5 (1 page deleted which will describe the
development costs and reimbursement
procedures)
ATTACHMENT 6 (1 page deleted which will describe the
premarketing expenses and reimbursement
procedures)
ATTACHMENT 7 (1 page deleted which will describe the
research program terms and conditions)
<PAGE>
Exhibit 10.55
PORTIONS OF THIS DOCUMENT HAVE BEEN OMITTED (DESIGNATED BY AN
ASTERIX (*) AND WHITE SPACE) AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT
FILED JANUARY 31, 1995; FILE NO. 0-15609
THIRD AMENDMENT
Effective January 15, 1995, Agouron Pharmaceuticals, Inc., a California
corporation with offices at 10350 North Torrey Pines Road, Suite 100, La
Jolla, California 92037 ("Agouron") and Japan Tobacco Inc., a Japanese
corporation with offices at 12-62, Higashi-Shinagawa 4 chome, Shinagawa-ku,
Tokyo 140, Japan ("JT"), for good and valuable consideration, agree as
follows:
Article I
Background
1.01 Pursuant to the terms of an agreement which was originally
entered into on December 18, 1992 (This Agreement, as amended, is hereinafter
referred to as "Agreement One."). Agouron and JT have conducted a
collaborative Research Program ("Research Program One") consisting of *
to discover, develop, manufacture and
market novel immunosuppressive drugs. On February 28, 1994, Agouron and
JT entered into the First Amendment of Agreement One. On April 22,
1994, Agouron and JT entered into the Second Amendment and Restatement
of Agreement One.
1.02 Agouron and JT are also conducting two additional Research
Programs ("Research Program Two" and "Research Program Three") focusing on
the development of anti-viral drugs in accordance with the provisions of
agreements which were originally entered into on February 28, 1994
("Agreement Two" and "Agreement Three").
1.03 *
To affect the preceding and to clarify
the parties' rights and obligations, the parties agree to further amend
the terms of Agreement One by entering into this Third Amendment to
Agreement One ("Third Amendment").
1.04 For purposes of this Third Amendment, terms with initial
capitalization shall have the same meanings as those set out in Agreement
One.
Article II
Third Amendment
2.01 The parties agree that the last day of the Research Term of
Agreement One is January 15, 1995 and that Research Program One ended on
January 15, 1995.
<PAGE>
2.02 The parties agree that only chemical compounds which have been
shown by or on behalf of Agouron or JT, independently or jointly, on or
before the last day of the Research Term to *
shall be eligible to be Program Compounds, and that any chemical
compounds synthesized after January 15, 1995 shall not be eligible to be
Program Compounds.
2.03 The parties agree that no Program Compounds or Program Products
were conceived and/or invented in Research Program One during the Research
Term.
2.04 The parties agree that the chemical compounds contained in the
List of Research Program One Compounds dated as of January 15, 1995 are not
Program Compounds or Program Products.
2.05 The parties agree that the parties' rights and obligations
regarding the commercialization of any chemical compounds and intermediates
thereof which were invented in Research Program One including, but not
limited to, the chemical compounds contained in the List of Research Program
One Compounds dated as of January 15, 1995, and any products incorporating
such chemical compounds, are set forth in Section 3.05(g) of the Second
Amendment and Restatement of Agreement One, which Section 3.05(g) reads
in full as follows:
(g) Unless the parties agree otherwise, any chemical
compound(s) which is *
The parties shall *
the most *
Each
party, as * shall have the *
2.06 The parties agree that * does not
include any know-how, trade secret, experimental data, formula, expert
opinion, experimental procedure and other confidential and/or proprietary
information *
which is *
as the case may be, *
2.07 The parties shall cause their respective employees to cooperate
as reasonably required to co-author manuscripts and to file patent
applications on separately or jointly made inventions arising out of
Agreement One.
2.08 The parties agree that Research Project II is canceled
effective January 15, 1995. *
<PAGE>
2.09 The parties agree to end Research Project I effective
January 15, 1995 and to reallocate the research efforts which were to be
committed by Agouron scientists during the third year of Research Project I
to Research Programs Two and Three. Notwithstanding the reallocation of
Agouron's research efforts, *
2.10 Commencing *
without any further action *
on its own or with any third party, *
agrees not to *
agrees not to *
The
parties hereby agree that any *
If requested by *
2.11 Except as modified by the terms contained herein, the
provisions of Agreement One shall remain in full force and effect.
2.12 Notwithstanding the *
hereby confirms that such *
AGOURON PHARMACEUTICALS, INC. JAPAN TOBACCO INC.
By /S/ R. Kent Snyder By /S/ Tsuyoshi Sasaki
Name R. Kent Snyder Name Tsuyoshi Sasaki
Title Vice President, Business Development Title Executive Director
Date January 26, 1995 Date January 26, 1995
