EXHIBIT 10.70
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
THIS AGREEMENT is made this 31st day of May, 1993 (the "Effective
Date") by and between EISAI CO., LTD. ("Eisai"), a Japanese corporation with its
principal executive offices at 0-00, Xxxxxxxxxx 0-xxxxx, Xxxxxx-xx, Xxxxx
112-88, Japan, and GENPHARM INTERNATIONAL, INC. ("GenPharm"), a
California corporation with its principal executive offices at 000 Xxxxx
Xxxxxxxx Xxxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000, Xxxxxx Xxxxxx of America.
RECITALS
A. Eisai and GenPharm previously executed a letter of intent dated March
30, 1993, contemplating the conduct by GenPharm, with the close cooperation of
Eisai, of a program of research and development with the goal of generation of
anti-CD4 human monoclonal antibodies in transgenic mice suitable for use in
human therapy and diagnostics, and supply by GenPharm to Eisai of preclinical
and clinical grade antibody material for Japanese preclinical and clinical
studies in accordance with the requirements of Japanese regulatory authorities.
B. The parties wish to set forth their agreement regarding such program
of research and development.
AGREEMENT
In consideration of their mutual promises and covenants, Eisai and
GenPharm agree as follows:
ARTICLE I - DEFINITIONS
The following terms when used in this Agreement shall have the
respective meanings assigned to them below.
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Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as "[*****]".
1.01 Affiliate of either party or other entity shall mean any
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corporation, firm, association or other legal entity that directly or indirectly
controls, is controlled by, or is under common control with, such entity, but
only for so long as said control continues. For purposes of this definition,
"control" means possession of the power, whether or not normally exercised, to
direct the management and affairs of an entity, directly or indirectly, whether
through the ownership of voting securities, by contract or otherwise. In the
case of a corporation, the direct or indirect ownership of 50% or more of its
outstanding voting shares shall in any case be deemed to confer control, while
the ownership of a lower percentage of such securities shall not necessarily
preclude the existence of control.
1.02 Affiliate and Sublicensee Revenues shall mean all consideration
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except for purchase price of Anti-CD4 Antibodies received by Eisai from
Affiliates or sublicensees that is fairly attributable to Eisai's sales of Anti-
CD4 Antibodies or sublicensing of rights under GenPharm Patent Rights or
GenPharm Know-How in Other Asian Countries, including such consideration
received in the form of license fees, initial payments, technical assistance
fees and royalties.
1.03 Anti-CD4 Antibodies shall mean human anti-CD4 monoclonal antibodies
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produced from Transgenic Mice (as hereinafter defined) and developed in the
course of the Research Program (as hereinafter defined).
1.04 Date of First Commercial Sale shall mean the date on which Anti-CD4
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Antibodies are first sold by Eisai in Japan in accordance with this Agreement
in a commercial transaction to an unrelated third party.
1.05 Field of Use shall mean the use of Anti-CD4 Antibodies in human
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therapy. If expanded in accordance with Section 4.04, Field of Use shall also
include the use of Anti-CD4 Antibodies in human diagnostics.
1.06 GenPharm Know-How shall mean any information, data and/or materials
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possessed, acquired and/or developed by GenPharm on or prior to the Effective
Date or during the term of this Agreement relating to Anti-CD4 Antibodies that
are not generally known or available, which information, data
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and materials are necessary or useful in order to manufacture, use, conduct
research and/or development relating to, sell or seek approval to market Anti-
CD4 Antibodies and, in particular, any such information, data or materials
relating to processes for preparing, using or formulating or to the
pharmacological, biological or clinical properties of Anti-CD4 Antibodies.
1.07 GenPharm Patent Rights shall mean:
-----------------------
(a) Patents and/or patent applications in the Territory that
GenPharm now owns or controls or that GenPharm may come to own
or control at any time during the term of this Agreement as
listed in Appendix A attached hereto, which Appendix shall be
promptly revised by the parties to account for any and all
patents or patent applications that GenPharm may come to own or
control in the Territory following the Effective Date;
(b) Patents in the Territory issued from applications described in
(a) above or from divisionals or continuations of such
applications;
(c) Claims of continuation-in-part applications in the Territory,
and of the resulting patents, which are directed to subject
matter specifically described in the patents and/or patent
applications described in (a) or (b) above;
(d) Claims of all later filed patent applications in the Territory,
and of the resulting patents, which are directed to subject
matter specifically described in the patents and/or patent
applications described in (a), (b), or (c) above; and
(e) Any reissues of patents described in (a), (b), (c) or (d) above.
For purposes of this definition, "control" by GenPharm of a patent or
patent application shall mean GenPharm's having the right to grant to Eisai
licenses or sublicenses thereunder within the Field of Use and in the Territory,
without violating any rights of or obligations to third parties. Control may
arise through ownership or license or other contractual rights.
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1.08 Net Third Party Sales [*****]
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1.09 Other Asian Countries shall mean all countries within the Territory
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other than Japan.
1.10 Product Liability shall mean liability to a third party resulting
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from the consumption, handling or use of Anti-CD4 Antibodies which occurs away
from the premises of GenPharm or Eisai after GenPharm or Eisai have relinquished
possession.
1.11 Program Committee shall mean [*****]
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1.12 Research Field shall mean the conduct of research and development
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activities related to the generation of Anti-CD4 Antibodies in Transgenic Mice.
1.13 Research Goal shall-mean generation of Anti-CD4 Antibodies in
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Transgenic Mice, and supply by GenPharm to Eisai of the quantities specified
in Sections 2.03 and 3.04 of preclinical and clinical grade biological material
containing Anti-CD4 Antibodies suitable for Japanese preclinical and clinical
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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studies in accordance with the requirements of Japanese regulatory authorities.
1.14 Research Program shall have the meaning assigned to it in Section
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2.01 below.
1.15 Territory shall mean Japan and the other Asian countries that are
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listed on Appendix B attached hereto.
1.16 Transgenic Mice shall mean GenPharm proprietary mice that are
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transgenic for unrearranged human immunoglobulin genes.
ARTICLE II - RESEARCH PROGRAM
2.01 Program of Research. In a program of research and development
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(the "Research Program"), GenPharm, with the close cooperation of Eisai, shall
use its best efforts, including the provision of qualified personnel, equipment,
materials and facilities, to achieve the Research Goal. An outline of activities
that GenPharm shall perform in the course of the Research Program is
attached hereto as Appendix C. Appendix C may be revised at any time with the
written consent of both parties, which consent shall not unreasonably be
withheld. Eisai may have access to all data and information relating to the
Research Program during the term of the Agreement. The Research Program
shall continue until December 31, 1995, and shall then terminate unless
extended by agreement of the parties.
2.02 Oversight. The conduct of the Research Program shall be overseen
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and supervised by the Program Committee. Within 30 days after the end of each
calendar quarter, GenPharm shall provide the Program Committee with research
progress reports containing a reasonably detailed description of the work
conducted by it in the course of the Research Program during the preceding
quarter and of the results thereof. Research progress and results shall be
discussed by the parties at meetings of the Program Committee, which shall bc
held no less frequently than quarterly and more often as need arises.
5
2.03 Information and Materials for Regulatory Studies. GenPharm shall,
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without any additional charge, provide Eisai with any and all GenPharm Know-How
in connection with the manufacture, use and sale of Anti-CD4 Antibodies in the
Territory during the term of this Agreement. Eisai may dispatch its scientist(s)
to GenPharm for acquiring GenPharm Know-How during the term of this Agreement
subject to agreement by the parties hereto.
Also, GenPharm shall without additional charge provide to Eisai five (5)
grams of preclinical grade and twenty-five (25) grams of clinical grade Anti CD4
Antibody material for use as Eisai may determine in regulatory studies in Japan.
The specifications of said preclinical and clinical grade anti-CD4 Antibody
material shall be determined by agreement of the parties. Moreover, GenPharm
shall provide to Eisai all protocols and results from GenPharm's own preclinical
and clinical study activities so that Eisai may decide upon additional work that
may be necessary to satisfy Japanese regulatory requirements.
In addition, ten (10) days following its receipt of the first benchmark
payment scheduled in Section 3.02(a), GenPharm shall transfer a working cell
bank to Eisai to enable Eisai to perform feasibility studies or generate
additional antibody material.
Eisai shall provide to GenPharm the results of all preclinical and
clinical studies conducted by Eisai in Japan for the purpose of Japanese
regulatory requirements. Eisai shall have and retain sole ownership of the
results of all preclinical and clinical studies conducted by Eisai. Eisai hereby
grants to GenPharm a non-exclusive and royalty-free license in the Field of Use
and outside the Territory to use the results of all preclinical and clinical
studies conducted by Eisai (without any right of sublicense except on a basis
where the sublicensee agrees to grant a non-exclusive and royalty-free license
in the Field of Use and in the Territory to Eisai to use the results of
all corresponding preclinical and clinical studies conducted by GenPharm's
sublicensee).
2.04 Exclusivity. During the term of this Agreement, GenPharm shall
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not act within the Research Field and the Territory for anyone other than Eisai.
6
ARTICLE III - PAYMENTS TO GENPHARM RELATED TO RESEARCH
PROGRAM
3.01 Research Payments. [*****]
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3.02 Benchmark Payments. [*****]
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***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
7
[*****]
3.03 Withholding Tax. Payments due to GenPharm under Sections 3.01 or
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3.02(a) and 3.02(b) will be made without any withholding for or on account of
taxes or other charges. If Japanese taxing authorities subsequently determine
that taxes should have been withheld on any such payments and assess Eisai for
such taxes, GenPharm will pay or reimburse Eisai for the taxes so assessed,
together with any interest or penalties required to be paid thereon. GenPharm
agrees to provide any cost information requested by the Japanese taxing
authorities, and otherwise to cooperate with Eisai in seeking to establish that
the payments are not subject to withholding. Any tax which may be required
by Japanese taxing authorities to be withheld on the payments provided for in
Section 3.02(c) shall be deductible from the payments, provided that Eisai shall
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
8
furnish GenPharm with a copy of the official tax receipt for the payment of such
withholding tax.
3.04 Supply of Additional Material for Regulatory Studies. For
GenPharm's supply to Eisai of any antibody material for regulatory studies in
Japan in excess of the five (5) grams of preclinical grade material and twenty-
five (25) grams of clinical grade material to be furnished to Eisai in
accordance with Section 2.03, Eisai shall pay GenPharm an amount equal to
[*****] along with any invoice sent to Eisai.
ARTICLE IV - OWNERSHIP OF INVENTIONS, GRANT OF LICENSE, AND
PATENTS
4.01 Ownership of Intellectual Property. Each party shall have and
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retain sole ownership of technical information and data, know-how, trade
secrets and inventions, whether or not patented or patentable, developed or
made by its own employees, consultants or agents. The parties shall have joint
ownership of technical information and data, know-how, trade secrets and
inventions (the "Jointly-Owned Technology"), whether or not patented or
patentable, developed or made jointly by employees, consultants or agents of
each party during the term of this Agreement. Each party shall have the right
(with the right to sublicense) to use the Jointly-Owned Technology in
perpetuity for any purpose without accounting to the other party.
4.02 Filing and Prosecution of Patent Applications. GenPharm shall, at
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its own expense, prosecute and maintain the Japanese patent applications
included in the GenPharm Patent Rights. Unless otherwise agreed in writing
by the parties, GenPharm shall, in its own name and at its sole expense, file,
prosecute and maintain in Japan any patent applications relating to Anti-CD4
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
9
Antibodies that GenPharm has filed in any country outside the Territory, and
shall use reasonable efforts to obtain and maintain patent registrations based
on such applications.
GenPharm may, in its own name and at its sole expense, file, prosecute
and maintain patent applications covering GenPharm Patent Rights in Other Asian
Countries. In the event that GenPharm fails to file, prosecute and maintain a
patent application covering such GenPharm Patent Rights in any Other Asian
Country within sixty (60) days after Eisai has requested that it do so, Eisai
may, in GenPharm's name but at Eisai's sole expense, file, prosecute and
maintain such application in such country. Eisai may recover the costs of any
such patent application filing, etc., by it through deduction from payments due
to GenPharm under Section 5.02 or 5.03 in respect of activities in such country,
but not so as to reduce any such payment, after allowance of any deductions
permitted under Section 5.04, by more than [*****] (if the payment is a royalty
at the rate of [*****] Net Third Party Sales or a [*****] share of Affiliate and
Sublicensee Revenues) or [*****] (if the payment is a royalty at the rate of
***** of Net Third Party Sales or a [*****] share of Affiliate and Sublicensee
Revenues).
4.03 License. GenPharm hereby grants to Eisai and its Affiliates the
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exclusive (even as to GenPharm) right and license (with the right to sublicense
upon prior written notice to GenPharm, except that sublicensing of manufacturing
rights shall require GenPharm's prior written approval, which approval shall not
unreasonably be withheld) within the Field of Use and in the Territory under the
GenPharm Patent Rights and GenPharm Know How to manufacture, use and sell Anti-
CD4 Antibodies under Eisai's trademarks or trade names, subject to the
obligation to pay royalties to GenPharm in accordance with Article V.
In case Eisai exercises the right to manufacture Anti-CD4 Antibodies,
Eisai shall give GenPharm at least eighteen (18) months' prior written notice
of its intention to exercise such right.
The term of this license shall continue until the later of (a) the date
of expiration or other termination of the last to expire or terminate of the
GenPharm Patent Rights in Japan, or (b) fifteen (15) years from the Date of
First Commercial Sale. Following such term, the license under this Section 4.03
shall become non-exclusive, perpetual and royalty-free.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
10
4.04 Expansion of Field of Use. [*****]
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4.05 Patents on Jointly-Owned Technology. Eisai shall have the right to
-----------------------------------
file, in the joint names of GenPharm and Eisai and at Eisai's sole expense,
patent applications in any country in the Territory with respect to Jointly-
Owned Technology. GenPharm shall have the right to file, in the joint names
of GenPharm and Eisai and at GenPharm's sole expense, patent applications in
any country outside the Territory with respect to Jointly-Owned Technology.
In the event that either party elects not to exercise its right to file a patent
application with respect to the Jointly-Owned Technology in any country in
which it had the right to file such application within six (6) months after it
has been requested to do so by the other party, the other party shall have the
right to file an application in such country in its own name and at its sole
expense.
4.06 Enforcement of Patents Covering Jointly-Owned Technology. Eisai
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may, at Eisai's sole expense, enforce patent protection for any patent or
application related to the Jointly-Owned Technology that was filed by Eisai in
any country in the Territory. GenPharm may, at GenPharm's sole expense,
enforce patent protection for any patent or application related to the Jointly-
Owned Technology that was filed by GenPharm in any country outside the
Territory. In the event either party elects not to enforce patent protection
for any patent covering Jointly-Owned Technology filed by it, the other party
may do so in its own name and at its sole expense. The party enforcing patent
protection in accordance with this Section may retain any damages awarded in
enforcement proceedings.
4.07 Cooperation. The parties agree to cooperate with and inform each
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other with respect to patent filing and enforcement for the Jointly-Owned
Technology and GenPharm Patent Rights.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
11
ARTICLE V - ROYALTIES AND BULK PURCHASE PRICE
5.01 Supply Agreement. Upon request of Eisai, GenPharm agrees to
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supply Eisai with bulk Anti-CD4 Antibodies under separate agreement to be
entered into between the parties.
5.02 Earned Royalties. [*****]
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5.03 Affiliate and Sublicensee Revenues. [*****]
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5.04 Third Party Royalties. [*****]
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***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
12
[*****]
5.05 Bulk Purchase Price. [*****]
-------------------
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
13
[*****]
5.06 Warranty. GenPharm will warrant that any bulk Anti-CD4 Antibodies
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supplied by it to Eisai, under a bulk supply agreement as set forth in Section
5.01 shall conform in all respects to the specifications to be agreed upon in
writing by the parties in due course.
5.07 Regulatory Compliance. GenPharm shall comply with all applicable
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cGMP's and cGLP's relating to Anti-CD4 Antibodies. The term "cGMP's" means the
current Good Manufacturing Practices as described in Title 21 of the United
States Code of Federal Regulations, Parts 210 and 211, as in effect from time to
time. The term "cGLP's" means the current Good Laboratories Practices as
described in Title 21 of the United States Code of Federal Regulations, Part 58,
as in effect from time to time.
5.08 Diligent Effort. Eisai shall diligently endeavor to commercialize
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Anti-CD4 Antibodies within the Field of Use in [*****]
5.09 Payments. Computations and Records
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(a) Earned royalty payments and payments of Affiliate and Sublicensee
Revenues shall be due within forty-five (45) days after the close of the
calendar quarter in which they accrue. Each payment shall be accompanied by a
report setting forth the following:
(i) the amount of Net Third Party Sales, by product and country
of sale;
(ii) the amount of Affiliate and Sublicensee Revenues, by product
and country of sale or sublicensing; and
(iii) the amount of royalty or share of Affiliate and Sublicensee
Revenues due for the quarter.
(b) Payments hereunder shall be made in United States dollars or in
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
14
such other currency or currencies as the parties may agree, subject to
deduction of any taxes or other charges required to be paid or withheld under
applicable laws, regulations or threaty, provided a copy of the official tax
receipt or other official receipt for any such deduction is furnished to the
payee. Net Third Party Sales or Affiliate and Sublicensee Revenues not
denominated in United States dollars and the amounts payable thereon shall
first be determined in the currency in which such Net Third Party Sales or
Affiliate and Sublicensee Revenues were realized, and shall then be convened
into the equivalent number of United States dollars at the average of the
closing buying and selling exchange rates, two days prior to the date of
payment, established by the Tokyo foreign exchange market.
(c) Interest shall accrue and be payable on overdue payments at the
rate of 10% per annum.
(d) Eisai shall keep full and accurate books and records setting forth
its and its Affiliates' and sublicensees' gross sales or other transfers for
value of Anti-CD4 Antibodies and sublicensing activities hereunder, the Net
Third Party Sales and Affiliate and Sublicensee Revenues, and the amounts
payable to GenPharm as provided above.
Eisai shall permit independent certified public accountants selected by
GenPharm and reasonably acceptable to Eisai to examine such books and
records upon reasonable notice during normal working hours, but not later
than two years following the payment in question, for the purpose of
verifying the reports, accountings and payments hereunder. Such
independent accountants shall not disclose to GenPharm any cost data or other
confidential information of Eisai or its Affiliates or sublicensees. The opinion
of such independent accountants regarding such report, accountings and payments
shall be binding on the parties hereto. The fees and expenses of the independent
accountants shall be paid by GenPharm, except that if the opinion of the
independent accountants shows that less than 95% of the amounts due to GenPharm
has been reported and paid, such fees and expenses shall be paid by Eisai.
15
ARTICLE VI - TERM AND TERMINATION
6.01 Term and Termination. This Agreement shall be deemed to have
--------------------
become effective on the Effective Date, and shall expire upon expiration of the
term of the exclusive license granted under Section 4.03. This Agreement may
be terminated:
(a) at any time, upon agreement of the parties;
(b) by Eisai, upon 180 days' notice to GenPharm;
(c) by either party immediately, if the other party materially
defaults in the performance of any of its obligations hereunder
and such default continues uncured for a period of ninety (90)
days after the date of written notice of such default; or
(d) by either party immediately, if the other party shall have
become insolvent or bankrupt, or any case or proceeding shall
have been commenced by or against the other party in bankruptcy
or seeking liquidation, dissolution or winding-up, and any such
event shall have continued for sixty (60) days without being
dismissed, bonded or discharged (during which period Eisai's
payment obligations to GenPharm hereunder shall be suspended).
6.02 Effect of Expiration or Termination. The expiration or termination
------------------------------------
of this Agreement shall not affect the rights or obligations of the parties that
have accrued prior to such expiration or termination. Article VII shall survive
the expiration or termination of this Agreement.
6.03 Termination Due to Delay or Failure to Generate Antibodies. If the
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Research Program is delayed substantially from the schedule set forth in
Appendix C attached hereto for any reason whatsoever, including resignation or
departure of key GenPharm employees, or GenPharm fails to generate, as confirmed
by Eisai, Anti-CD4 Antibodies in Transgenic Mice, with specificity and affinity
as defined in Appendix D, by Xxxxx 00, 0000, Xxxxx may give notice to GenPharm
of its intention to terminate this Agreement if the delay in the Research
Program or failure to generate antibodies is not cured within the
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next 240 days (during which period Eisai's payment obligations to GenPharm
shall be suspended).
At the end of such 240 day period if no such cure has been effected, and
for the ensuing thirty (30) days (or such further period as the parties may
agree), Eisai shall have the right to terminate this Agreement by notice to
GenPharm. In such event, the license granted to Eisai in Section 4.03 shall
terminate, but GenPharm shall provide to Eisai all GenPharm Know-How and
biological materials relating to Anti-CD4 Antibodies developed during the term
of this Agreement for Eisai's use on such terms and conditions, including
reasonable compensation to GenPharm, as the parties may agree. The parties
shall endeavor in good faith to agree upon terms and conditions for the use of
such know-how and materials that would be fair to each. If they are unable to
agree, the matter shall be resolved in accordance with Section 8.13.
6.04 Rights After Termination Due to Breach by GenPharm. In the event
---------------------------------------------------
that Eisai terminates this Agreement in accordance with the provisions of
Section 6.01(c) or (d), the license granted to Eisai in Section 4.03 shall
survive and become royalty-free. In such event, GenPharm shall provide to Eisai,
without charge, all GenPharm Know-How and biological materials relating to Anti-
CD4 Antibodies developed during the term of this Agreement, for Eisai's use as
permitted by the terms of such license.
6.05 Rights After Termination Due to Breach by Eisai. In the event that
-----------------------------------------------
GenPharm terminates this Agreement in accordance with the provisions of
Section 6.01(c) or (d), the license granted to GenPharm in Section 2.03 shall
survive. In such event, Eisai shall provide to GenPharm, without charge, all
results of preclinical and clinical studies conducted by Eisai under this
Agreement, for GenPharm's use as permitted by the terms of such license.
ARTICLE VII - CONFIDENTIALITY
During the term of this Agreement and thereafter until the expiration
of five (5) years from the date of receipt thereof, each party shall keep
strictly confidential, and shall not use for any purpose other than the matter
hereof, any and all information and materials received from the other party
which
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the disclosing party designates as confidential ("Confidential Information and
Materials"). Information and materials developed by GenPharm in the course
of the Research Program shall be deemed to be Confidential Information and
Materials disclosed to Eisai by GenPharm. There shall not be considered as
Confidential Information and Materials any information or materials which:
(a) is or are already part of the public domain at the time of
disclosure or generation under this Agreement or thereafter
becomes or become part of the public domain otherwise than by
breach of this confidentiality obligation;
(b) the receiving party can show by competent proof had already
come into its possession without violation of this Agreement
at the time of disclosure or generation under this Agreement;
or
(c) is communicated by a third party which did not receive the
same directly or indirectly from either party or from any
other party under a binder of confidentiality.
Each party may disclose Confidential Information or Materials with the
prior written approval of the disclosing pany, to third parties having a valid
need to know and who enter into confidentiality agreements with the
disclosing party containing restrictions on further disclosure and use no less
stringent than the provisions of this Article VII, or as it deems necessary
(a) in obtaining, maintaining, prosecuting or defending patents
in accordance with Sections 4.02, 4.05 and 4.06 above;
(b) in prosecuting or defending litigation;
(c) in connection with clinical trials or as otherwise required
for obtaining regulatory approvals; or
(d) in complying with applicable laws or regulations or
fulfilling the disclosure requirements of any securities
regulatory agency or securities exchange in the event of a
securities offering by it;
provided that it gives the disclosing party prior notice of such disclosure and
takes reasonable actions to limit the disclosure.
Upon expiration or termination of this Agreement, each party shall
promptly deliver to the other party all records in its possession or control
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containing Confidential Information furnished to it by, and all Confidential
Materials belonging to, the other party, other than an archival set to be
retained by its legal department for compliance purposes.
Notwithstanding the foregoing, either party may retain all records in
its possession or control containing Confidential Information and all
Confidential Materials furnished to it by the other that directly relates to any
of its license rights that survive such expiration or termination.
ARTICLE VIII - MISCELLANEOUS
8.01 Regulatory Matters. Eisai shall endeavor, with the close
------------------
cooperation of GenPharm, to obtain regulatory approvals and authorizations
required for the commercialization of Anti-CD4 Antibodies within the Field of
Use [*****]
8.02 Adverse Drug Experiences. Each party shall promptly provide the
------------------------
other party with any information that it possesses with respect to adverse drug
experiences associated with Anti-CD4 Antibodies.
8.03 Independent Contractor. Nothing in this Agreement is intended or
----------------------
shall be deemed to constitute a partnership, agency, employer-employee or joint
venture relationship between the parties. All activities by the parties
hereunder shall be performed by them as independent contractors. Neither party
shall incur any debts or make any commitments for or on behalf of the other
party, unless specifically authorized in writing by an officer of the other
party.
8.04 DISCLAIMER OF WARRANTIES: LIMITATION OF LIABILITY. UNLESS
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OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, GENPHARM DISCLAIMS ALL
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. IN NO
EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES
ARISING OUT OF ANY BREACH OF THIS AGREEMENT.
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
19
8.05 Risk. Unless otherwise provided for in this Agreement, each party
----
assumes any and all risks of personal injury or property damage attributable
to the negligent acts or omissions of that party or the officers, employees or
agents thereof. Unless otherwise provided for in this Agreement, each party
shall indemnify the other party and its officers, directors, employees and
agents against and hold them harmless from any loss, damage, liability or
expense (including legal costs) resulting from the indemnifying party's
conduct.
8.06 Representation Regarding GenPharm Patent Rights. [*****]
-----------------------------------------------
In the event that Eisai has reason to believe that a third party is
infringing upon the rights granted hereunder in the Territory, Eisai shall
notify GenPharm, and GenPharm may, at GenPharm's sole expense, promptly
take legal action against such third party. Eisai shall cooperate with
GenPharm with respect to such legal action. If GenPharm does not take legal
action or proceed diligently with such legal action within a reasonable time
after receipt of such notice from Eisai, Eisai shall have the right, at Eisai's
sole expense, to take legal action, and GenPharm shall reimburse Eisai for its
entire expenses related to such legal action. If GenPharm takes such legal
action, any damages that may be recovered, after reimbursement to GenPharm
of its costs of litigation, including attorneys' fees, shall be divided equally
between the parties. If Eisai takes such legal action, any damages that may be
recovered may be retained by Eisai.
8.07 General Indemnification.
-----------------------
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
20
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
21
[*****]
8.08 Limitations on Assignment. Neither this Agreement nor any
-------------------------
interest hereunder shall be assignable by either party by operation of law or
otherwise without the prior written consent or agreement of the other, except
in connection with the sale by GenPharm of all or substantially all of its
assets to any person or entity other than a major Japanese pharmaceutical
company or its Affiliate. This Agreement shall inure to the benefit of and shall
be binding upon the parties and their successors and permitted assigns, and the
name of a party appearing herein shall be deemed to include the names of such
party's successors and permitted assigns to the extent necessary to carry out
the intent of this Agreement.
8.09 Further Acts and Instruments. Each party agrees to execute,
----------------------------
acknowledge and deliver such further instruments and to do all such other
acts as may be necessary or appropriate to carry out the purpose and intent of
this Agreement.
8.10 Entire Agreement; Amendment. This Agreement constitutes and
---------------------------
contains the entire agreement of the parties with respect to its subject matter,
and supersedes all prior negotiations, correspondence, understandings and
agreements between the parties respecting the subject matter hereof. This
Agreement may be amended or modified or one or more provisions hereof may be
waived only by a written instrument signed by authorized officers of both
parties.
8.11 Severability. Whenever possible, each provision of this Agreement
------------
shall be interpreted in such a manner as to be effective and valid under
applicable law, but if any provision of this Agreement is held to be prohibited
by or invalid under applicable law, said provision shall be ineffective only to
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
22
the extent of such prohibition or invalidity, without invalidating the remainder
of such provision or the remaining provisions of this Agreement.
8.12 Headings and Captions. The headings and captions contained in this
---------------------
Agreement are for convenience only, and are to be of no force or effect in
construing and interpreting the provisions of this Agreement.
8.13 Disputes. Any controversy or claim arising out of or relating to
--------
this Agreement or the breach or alleged breach thereof which the parties fail to
settle amicably shall be finally settled by arbitration in accordance with the
Japan-American Trade Arbitration Agreement of September 16, 1952, by which each
party shall be bound.
If the arbitration is demanded by GenPharm, it shall be held in Tokyo,
Japan, and if the arbitration is demanded by Eisai, it shall be held in San
Francisco, California, U.S.A.
8.14 No Waiver for Failure to Enforce Compliance. Failure of either
-------------------------------------------
party to insist upon strict observance of or compliance with any of the terms of
this Agreement in one or more instances shall not be deemed to be a waiver of
its rights to insist upon observance of or compliance with such term thereafter,
or with any of the other terms of this Agreement.
8.15 No Trademark or Trade Name License. Neither party shall have any
----------------------------------
right to use, for advertising, publicity .or other commercial purposes, the name
or any trade name or trademarks, or contraction, abbreviation or simulation
thereof, of the other party without the latter's prior written consent.
8.16 No Announcements. Neither party shall make any announcements or
----------------
otherwise make public any information concerning this Agreement or GenPharm's
business dealings with Eisai except as approved by the other, which approval
shall not unreasonably be withheld; provided, however, that either party may
disclose such information in complying with applicable laws or regulations or
fulfilling the disclosure requirements of any securities regulatory agency or
securities exchange in the event of a securities offering by it.
23
8.17 Notices. Any notice, report, request, approval, payment, consent or
-------
other communication required or permitted to be given under this Agreement shall
be in writing and shall, for all purposes, be deemed to be fully given and
received if delivered in person or sent by registered mail, postage prepaid, to
the respective parties at their respective addresses set forth at the head of
this Agreement or by facsimile transmission to the following facsimile
telephone number of the party:
Eisai: (00) 0000-0000
GenPharm: (000) 000-0000
Either party may change its address or facsimile telephone number for facsimile
transmission for the purpose of this Agreement by giving the other party written
notice of its new address or facsimile telephone number.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed in duplicate by their respective authorized officers.
EISAI CO., LTD.
/s/ Xxxxx Xxxxx
By: Xxxxx Xxxxx
Title: President, CEO
Attested by
/s/ Tatsuo Kowsoki
Director Logistic Licensing
and International Relations
GENPHARM INTERNATIONAL, INC.
/s/ Xxxxxxxx XxxXxxxxx
By: Xxxxxxxx XxxXxxxxx
Title: Chief Executive Officer
Attested by
/s/ Xxxxxx Xxxxx Xxxxxxxxx
Law Office
Xxxxxx Xxxxx Xxxxxxxxx
24
CONFIDENTIAL
------------
APPENDIX A
----------
International National
DOCKET NO. Country Title/Subiect Inventor(s) Serial No. Serial No. Status/Action
---------- ------- ------------- ----------- ------------- ---------- -------------
000-0XX Xxxxx XXXXXXXXXX XXX-XXXXX XXXXXXX, XXX PCT/US91/06185 NOT YET AVAILABLE ENTERED NATIONAL
(14643-5JP) ANIMALS CAPABLE OF PHASE 02/28/93;
PRODUCING HETEROLOGOUS 08/28/98 REQUEST
ANTIBODIES EXAMINATION
106-2KR Korea TRANSGENIC NON-HUMAN XXXXXXX, XXX PCT/US91/06185 93-700594 ENTERED NATIONAL
(l4643-5KR) ANIMALS CAPABLE OF PHASE 02/28/93
PRODUCING HETEROLOGOUS
ANTIBODIES
000-xXX Xxxxx HOMOLOGOUS RECOMBINATION IN XXX, XXXXX PCT/US91/05917 NOT YET AVAILABLE ENTERED NATL.
(14643-32JP) MAMMALIAN CELLS XXXXXXXXXXX PHASE 02/28/93;
XXXXXX, STRIJKER 08/28/98 REQUEST
EXAMINATION
109-2PC PCT TRANSGENIC IMMUNODEFICIENT XXXXXXXX, XXXXX PCT/US92/04823 -- ENTER NATIONAL
(14643-33-lPC) NON-HUMAN ANIMALS PHASE 12/14/93
110-lPC PCT GENE TARGETING IN ANIMAL XXXXX, ROBANUS PCT/US92/07184 -- ENTER NATIONAL
(14643-3-lPC) CELLS USING ISOGENIC DNA MAANDAG, XX XXXXX PHASE 02/20/94
CONSTRUCTS
112-2PC PCT TRANSGENIC NON-HUMAN XXXXXXX, XXX PCT/US92/10983 -- 07/17/93 ELECT
(14643-9-2PC) ANIMALS FOR PRODUCING CHAPTER II
HETEROLOGOUS ANTIB0DIES
APPENDIX B
List of the Countries in the Territory
--------------------------------------
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
APPENDIX C
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
ATTACHMENT C-1
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
APPENDIX D
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
ATTACHMENT D-1
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
ATTACHMENT D-1
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
ATTACHMENT D-2
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
AMENDMENT NO. 1 TO
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
THIS AMENDMENT is effective as of the 10th day of October, 1995,
and amends the Cooperative Research and Development Agreement effective May
31,1993 (the "Agreement") between EISAI Co., LTD. and GENPHARM INTERNATIONAL,
INC. ("GenPharm").
The parties to the Agreement hereby amend the Agreement as follows:
[*****]
IN WITNESS WHEREOF, this Amendment has been signed by or on behalf
of the parties to the Agreement as of the date first set forth above.
EISAICO., LTD.
BY: /s/ Xxxxx Xxxxx
Name: Xxxxx Xxxxx
Title: CEO
GENPHARM INTERNATIONAL, INC.
By: /s/ Xxxxxxxx XxxXxxxxx
Name: X. X. XxxXxxxxx
Title: CEO
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
GENPHARM
INTERNATIONAL
AMENDMENT NO. 2 TO
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
THIS AMENDMENT is effective as of the a 26th day of April, 1996, and
amends the Cooperative Research and Development Agreement effective May 31, 1993
(the "Agreement") between EISAI CO., LTD. and GENPHARM INTERNATIONAL, INC.
("GenPharm"), as previously amended by Amendment No. 1 thereto effective as of
October 10, 1995.
The parties to the Agreement hereby agree as follows:
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
IN WITNESS WHEREOF, this amendment has been signed by or on behalf of
the parties to the Agreement as of the date first set forth above.
EISAI CO., LTD.
By: /s/ Hanuo Naito
Name: Hanuo Naito
Title: CEO
GENPHARM INTERNATIONAL, INC.
By: /s/ Xxxxxxxx XxxXxxxxx
Name: X.X. XxxXxxxxx
Title: CEO
SCHEDULE 1
[*****]
***** REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SEC.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
