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EXHIBIT 10.35
RESEARCH AGREEMENT
THIS AGREEMENT ("AGREEMENT") is entered into as of the _____ day of
_________, 1998 ("EFFECTIVE DATE") by and between RIBOGENE INC., a California
corporation ("RIBOGENE"), and DAINIPPON PHARMACEUTICAL CO., LTD. ("DAINIPPON"),
a corporation organized under the laws of Japan.
RECITALS
WHEREAS, RiboGene has developed screening assays and other technology
useful in the identification of anti-bacterial compounds; and
WHEREAS, Dainippon and RiboGene possess and will acquire libraries of
natural and synthetic compounds which have potential therapeutic pharmaceutical
utility; and
WHEREAS, RiboGene and Dainippon desire to establish a research
relationship where RiboGene will screen both company's compound libraries using
certain assays, and will conduct research with some or all of the compounds
which show activity in those assays;
WHEREAS, the parties desire to develop and commercialize one or more
compounds discovered under this Agreement under a separate agreement granting
Dainippon certain licenses ("LICENSE AGREEMENT") executed by and between the
parties of even date herewith;
WHEREAS, in connection with the establishment of the relationship
between the parties, on or before February 13, 1998 Dainippon is purchasing
shares of RiboGene stock in the amount of US$ 2 million pursuant to a stock
purchase agreement agreed upon between the parties on or before February 5,
1998;
NOW, THEREFORE, in consideration of the foregoing and the covenants and
promises contained herein, the parties agree as follows:
ARTICLE 1
DEFINITIONS
As used herein, the following terms shall have the following meanings:
1.1 "ACTIVE COMPOUND" shall mean each Dainippon or RiboGene
Substance which meets the criteria set forth in Exhibit 1.1 (including any such
Substance which was screened in Assays prior to the Effective Date and for which
the Research Committee determines that such criteria are met), and each
derivative or analogue thereof developed in the course of, but not after, the
Research Program or the Tail End Period, if such derivative or analog thereof
meets the criteria set forth in Exhibit 1.1.
1.2 "AFFILIATE" shall mean (i) any corporation or other entity
("Parent") which directly or indirectly owns or controls at least fifty percent
(50%) of the outstanding voting securities of a party, (ii) any corporation or
other entity in which a party owns or controls at least
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fifty percent (50%) equity interest, and (iii) any corporation or other entity
in which a Parent of a party owns or controls at least fifty percent (50%)
equity interest.
1.3 "ASSAYS" shall mean the Target specific assays of RiboGene
described in Exhibit 1.3, and any additional Target specific assays developed by
or licensed (with the right to sublicense) to RiboGene during the Research Term.
Prior to their use in the Research Program, Exhibit 1.3 shall be amended to
include such additional assays.
1.4 "COLLABORATION KNOW-HOW" shall mean all inventions, discoveries,
materials and information developed by either party in the course of the
Research Program, but not after the Research Program. Collaboration Know-How
shall not include Collaboration Patents.
1.5 "COLLABORATION PATENTS" shall mean any and all patents,
including, without limitation, any substitutions, extensions, reissues,
renewals, supplementary protection certificates and inventors' certificates,
which have not been held invalid or unenforceable by a non-appealable or
non-appealed decision of a court of competent jurisdiction, issuing from patent
applications filed in any jurisdiction, including, without limitation, any
provisionals, divisionals, continuations, continuations-in- part, which cover
inventions or discoveries made by either party alone or both parties jointly in
the course of the Research Program, but not after the Research Program.
1.6 "COLLABORATION TECHNOLOGY" shall mean all Collaboration Patents
and Collaboration Know-How.
1.7 "CONFIDENTIAL INFORMATION" shall mean a party's confidential
information, including, without limitation, Dainippon Know-How, RiboGene
Know-How, Collaboration Know-How, Research Plans, engineering designs and
drawings, research data, manufacturing processes and techniques, scientific,
manufacturing, marketing, and business plans, financial or personnel matters
relating to the party, its present or future products, sales, suppliers,
customers, employees, investors or business.
1.8 "DAINIPPON KNOW-HOW" shall mean all inventions, discoveries,
materials and information which both (i) Dainippon owns, controls or has a
license to (with a right to sublicense) as of the Effective Date or which arise
outside of the Research Program or the Development Program from time to time
during the term of this Agreement or the License Agreement, and (ii) are
necessary or useful for the conduct of the Research Program, the Development
Program, or the manufacture, use or sale of Products. Dainippon Know-How shall
not include Dainippon Patents.
1.9 "DAINIPPON PATENTS" shall mean any and all patents other than
Collaboration Patents, including, without limitation, any substitutions,
extensions, reissues, renewals, supplementary protection certificates and
inventors' certificates, which have not been held invalid or unenforceable by a
non-appealable or non-appealed decision of a court of competent jurisdiction,
issuing from patent applications filed in any jurisdiction, including, without
limitation, any provisionals, divisionals, continuations, continuations-in-part,
which (i) Dainippon owns, controls or has a license to (with the right to
sublicense) as of the Effective
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Date, and (ii) would be infringed by the conduct of the Research Program, the
Development Program, or the manufacture, use or sale of Products.
1.10 "DAINIPPON SUBSTANCES" shall mean those natural extracts,
natural compounds and synthetic compounds which Dainippon owns or has licensed
or sublicensed, and has the right to license or sublicense as of the Effective
Date or during the Research Term, and which are screened in Assays in the course
of the Research Program.
1.11 "DAINIPPON TECHNOLOGY" shall mean, collectively, the Dainippon
Patents, the Dainippon Know-How and the Dainippon Substances.
1.12 "DEVELOPMENT PROGRAM" shall mean the program of preclinical and
clinical development activities undertaken by Dainippon pursuant to the License
Agreement.
1.13 "FDA" shall mean the United States Food and Drug Administration.
1.14 "FIELD" shall mean therapeutic treatment of bacterial infections
in humans with anti-bacterial pharmaceutical products which have activity
against the Targets.
1.15 "GLP TOXICOLOGY STUDIES" shall mean the preclinical toxicology
studies carried out in accordance with Good Laboratory Practices described in
the U.S. Federal Register dated December 22, 1988, as amended, or the Japanese
or European equivalent, which are intended to enable the filing of an IND.
1.16 "INACTIVE DERIVED COMPOUND" shall mean each derivative or
analogue of Dainippon Substance or RiboGene Substance synthesized in the course
of, but not after, the Research Program, which does not meet the criteria set
forth in Exhibit 1.1.
1.17 "IND" stands for "Investigational New Drug Application" and
shall mean an application for approval by the FDA or the equivalent non-U.S.
regulatory authority, to commence human clinical testing of a drug.
1.18 "LICENSED BACK-UP COMPOUNDS" shall mean [*] Active Compounds
recommended by the Research Committee and selected by Dainippon which are of the
same chemical class as a Licensed Compound.
1.19 "LICENSED COMPOUND" shall mean a compound which is an Active
Compound and which is recommended by the Research Committee and selected by
Dainippon for GLP Toxicology Studies and further development under the License
Agreement.
1.20 "NDA" or "NEW DRUG APPLICATION" shall mean an application for
approval by the FDA or an equivalent non-U.S. authority required for the
marketing and sale of a Product in the Territory.
1.21 "PRODUCT" shall have the meaning as defined in the License
Agreement.
1.22 "REGULATORY APPROVAL(S)" shall mean all approvals of INDs and
NDAs, new drug approvals, marketing approvals, pricing approvals, licenses,
permits, and other
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authorizations, which are required for conducting clinical trials with a
Product, and for manufacturing and selling a Product in compliance with
applicable laws and regulations in the Territory;
1.23 "RESEARCH PROGRAM" shall mean the research program with respect
to the Targets described in Exhibit 1.23 hereto, as amended from time to time by
the Research Committee in accordance with Section 2.2(c).
1.24 "RESEARCH COMMITTEE" shall mean that committee formed pursuant
to Section 2.2 hereof.
1.25 "RESEARCH TERM" shall mean the period of three (3) years
commencing on the Effective Date, unless extended pursuant to Section 2.2(c).
1.26 "RIBOGENE KNOW-HOW" shall mean all inventions, discoveries,
materials and information which both (i) RiboGene owns, controls or has a
license (with a right to sublicense) as of the Effective Date or which arise
outside the Research Program or the Development Program during the term of this
Agreement or the License Agreement, and (ii) are necessary or useful for the
conduct of the Research Program, the Development Program, or the manufacture,
use or sale of Products. RiboGene Know-How shall not include RiboGene Patents.
1.27 "RIBOGENE PATENTS" shall mean any and all patents other than
Collaboration Patents, including, without limitation, any substitutions,
extensions, reissues, renewals, supplementary protection certificates and
inventors' certificates, which have not been held invalid or unenforceable by a
non-appealable or non-appealed decision of a court of competent jurisdiction,
issuing from patent applications filed in any jurisdiction, including, without
limitation, any provisionals, divisionals, continuations, continuations-in-part,
which (i) RiboGene owns, controls or has a license to (with the right to
sublicense) as of the Effective Date, and (ii) would be infringed by the conduct
of the Research Program, the Development Program, or the manufacture, use or
sale of Products.
1.28 "RIBOGENE SUBSTANCES" shall mean those natural extracts, natural
compounds and synthetic compounds which RiboGene owns or has licensed or
sublicensed, and has the right to license or sublicense as of the Effective Date
and during the Research Term, and which are screened in Assays in the course of
the Research Program.
1.29 "RIBOGENE TECHNOLOGY" shall mean, collectively, the RiboGene
Patents, the RiboGene Know-How, the RiboGene Substances, and the Assays.
1.30 "TAIL END PERIOD" shall mean the period of one (1) year from the
completion or termination of the Research Term, the purpose of which is to
permit Dainippon to select Licensed Compounds.
1.31 "TARGETS" shall mean ppGpp and Deformylase.
1.32 "TERRITORY" shall have the meaning as defined in the License
Agreement
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ARTICLE 2
RESEARCH PROGRAM
2.1 CONDUCT OF THE RESEARCH PROGRAM. RiboGene and Dainippon will
conduct the Research Program under the direction of the Research Committee.
2.2 RESEARCH COMMITTEE.
(a) FORMATION OF RESEARCH COMMITTEE. The Research Committee
shall consist of an equal number of members from Dainippon and RiboGene,
appointed and substituted by each party as necessary from time to time. Each
member shall have appropriate technical credentials and knowledge and ongoing
familiarity with the Research Program. The chairperson of the Research Committee
shall be an employee of the party hosting the meeting. All decisions of the
Research Committee shall be unanimous and shall be recorded in the minutes of
the Research Committee.
(b) MEETINGS OF RESEARCH COMMITTEE. The Research Committee
shall meet quarterly at such times as shall be mutually agreed upon by the
parties and at a site alternating between RiboGene's and Dainippon's place of
business, or as otherwise mutually agreed. Dainippon and RiboGene shall bear the
travelling expenses and accommodation charges of its own members attending
meetings of the Research Committee.
(c) RESPONSIBILITIES OF THE RESEARCH COMMITTEE. The Research
Committee shall coordinate the activities carried out under the Research Program
and monitor the progress of the Research Program. The Research Committee may
revise or extend the Research Program as necessary to achieve the overall goal
of discovering Active Compounds, developing Licensed Compounds, and
commercializing Products; provided, however, that any such revision or extension
shall be subject to agreement, if necessary, as to reimbursement of any
additional costs. In particular, the Research Committee shall carry out the
following responsibilities during the Research Term and the Tail End Period:
(1) define the yearly research and development objectives,
(2) determine which Dainippon or RiboGene Substances have
shown sufficient activity in one or more Assays to be
classified as an Active Compound,
(3) define and coordinate activities required to carry out
further development and optimization of Active
Compounds,
(4) recommend to Dainippon the Licensed Compounds and the
Licensed Back-Up Compounds for development under the
License Agreement and updating the list of Licensed
Compounds in Exhibit 4.2,
(5) determine the scope, countries, timing and other matters
relating to patent applications to be filed under this
Agreement.
(d) MODIFICATION OF CRITERIA FOR ACTIVE COMPOUND AND
LICENSED COMPOUND. The Research Committee shall monitor the appropriateness of
the criteria for Active Compound and Licensed Compound set forth in Exhibits 1.1
and Exhibit 2.3, respectively, in light of the results obtained from the
Research Program and may, if warranted,
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modify such criteria as necessary in order to achieve the objectives of the
Research Program. Any such modifications shall be in a writing, signed by both
parties, which amends Exhibit 1.1 or Exhibit 2.3, as the case may be.
2.3 SELECTION AND ABANDONMENT OF COMPOUNDS.
(a) ACTIVE COMPOUNDS. Each Dainippon Substance and RiboGene
Substance which meets the criteria set forth in Exhibit 1.1 to the satisfaction
of the Research Committee shall be designated as an Active Compound and shall be
further developed and optimized.
(b) LICENSED COMPOUNDS. Each Active Compound which meets the
criteria set forth in Exhibit 2.3 to the satisfaction of the Research Committee
may be recommended by the Research Committee to Dainippon which shall have the
right to select from those so recommended the Active Compound for the GLP
Toxicology Study and further development and commercialization under the License
Agreement. Such selection shall be made by written notice to RiboGene. Each
Active Compound so selected shall be designated a Licensed Compound and shall be
covered by the terms of the License Agreement.
(c) LICENSED BACK-UP COMPOUNDS. The Research Committee shall
recommend to Dainippon, and Dainippon shall select the Licensed Back-Up
Compounds for each Licensed Compound selected as hereinabove provided. Such
selection shall be made by written notice to RiboGene at the same time the
related Licensed Compound is selected. Dainippon shall have the right to
substitute any Licensed Back-Up Compound for the related Licensed Compound as
provided in the License Agreement.
(d) REMAINING ACTIVE COMPOUNDS AND SUBSTANCES. Each
Dainippon Substance, RiboGene Substance and Active Compound not selected as a
Licensed Compound or Licensed Back-Up Compound and each Inactive Derived
Compound shall be returned to the party having ownership thereof in accordance
with Section 3.1(c).
2.4 [*] During the term of the Research Program, RiboGene will [*]
at Dainippon's request and expense, [*] to facilitate and enhance the
collaboration between the parties under the Research Program. Dainippon will [*]
from time to time, at RiboGene's request and expense, [*]. Each party may
replace its visiting research scientist from time to time with a different
visiting research scientist.
2.5 OBLIGATION TO INFORM. Each party hereby agrees to keep the
Research Committee fully informed on a monthly basis of the progress of the
Research Program. Such monthly reports shall describe the results of the
research work carried out under the Research Program, including the results of
the screening activities conducted with the Assays and in vitro and in vivo
antibacterial activity tests, but shall not include information on inactive
Compounds or Substances, except that the information on those inactive Compounds
or Substances structurally related to Active Compound or possible Active
Compound shall be included in such monthly reports.
2.6 RESOURCE ALLOCATION. Each party shall devote the same degree of
attention, resources and diligence to its respective obligations under the
Research Program as it devotes to high priority compounds of its own discovery
and development programs. RiboGene shall devote
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an average of [*] to the Research Program during the Research Term. RiboGene
shall promptly inform Dainippon of any changes in the assignments of any such
FTEs and shall promptly add or substitute individuals of comparable or superior
skills into the Research Program, in place of one or more of the original FTEs,
as circumstances dictate, and shall inform Dainippon, in advance, of all plans
of such additions or substitutions of individuals.
2.7 ADDITIONAL TARGETS. At any time during the Research Term, the
parties may wish to expand the scope of the Research Program to cover targets in
addition to the Targets. The parties shall determine in good faith negotiations
whether they can agree on the terms of a separate agreement which shall cover
the discovery, development and commercialization of compounds acting on those
additional targets; provided, however, neither party shall be obligated to enter
into such negotiations or to reach agreement if negotiations are conducted.
2.8 EXCLUSIVE COLLABORATION. Dainippon and RiboGene agree that
during the term of this Agreement, the collaboration under the Research Program
shall be on an exclusive basis within the Field.
ARTICLE 3
OWNERSHIP OF INTELLECTUAL PROPERTY; LICENSE GRANTS
3.1 OWNERSHIP.
(a) DAINIPPON TECHNOLOGY. RiboGene acknowledges and agrees
that Dainippon is and shall remain the sole owner of the Dainippon Technology
and that RiboGene has no rights in or to any of them other than the license and
rights specifically granted herein and the licenses granted pursuant to the
License Agreement.
(b) RIBOGENE TECHNOLOGY. Dainippon acknowledges and agrees
that RiboGene is and shall remain the sole owner of the RiboGene Technology and
that Dainippon has no rights in or to any of them other than the rights
specifically granted herein and the license to be granted pursuant to the
License Agreement.
(c) COLLABORATION TECHNOLOGY.
(i) Dainippon shall own all rights under
Collaboration Technology regarding Active Compounds, Licensed Compounds,
Licensed Back-Up Compounds, Inactive Derived Compounds and Products which are
Dainippon Substances, or which are derived by Dainippon from Dainippon
Substances. RiboGene shall have no rights to such Collaboration Technology owned
by Dainippon except as expressly granted under this Agreement or the License
Agreement.
(ii) RiboGene shall own all rights under
Collaboration Technology regarding Active Compounds, Licensed Compounds,
Licensed Back-Up Compounds, Inactive Derived Compounds and Products which are
RiboGene Substances, or which are derived by RiboGene from RiboGene Substances.
Dainippon shall have no rights to such Collaboration Technology owned by
RiboGene except as expressly granted under this Agreement or the License
Agreement.
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(iii) The parties shall jointly own all rights under
Collaboration Technology regarding Active Compounds, Licensed Compounds,
Licensed Back-Up Compounds, Inactive Derived Compounds and Products which are
derived by RiboGene from Dainippon Substances or by Dainippon from RiboGene
Substances.
(iv) The parties understand that the optimization of
Active Compounds and generation of derivatives of the Dainippon Substances and
the RiboGene Substances shall be conducted by each party primarily with its own
Substances, unless the parties specifically agree otherwise in writing. The
parties understand further that such agreement shall not be unreasonably
withheld if this would result in significant delays in the progress of the
Research Program.
(v) Collaboration Technology which does not relate
to Active Compounds, Licensed Compounds, Licensed Back-Up Compounds, Inactive
Derived Compounds or Products shall be owned by either party alone or jointly
with the other party depending on whether such Collaboration Technology was
developed by a party alone or jointly with the other party. Inventorship shall
be determined in accordance with the rules of inventorship under U.S. patent
laws. Neither party shall have rights to such Collaboration Technology owned
solely by the other party except as expressly granted under this Agreement or
the License Agreement.
3.2 MUTUAL RESEARCH LICENSE.
(a) LICENSE GRANT. Each party hereby grants to the other
party non-royalty bearing, worldwide, non-exclusive licenses under Dainippon
Technology, RiboGene Technology, and Collaboration Technology, respectively, for
the sole purpose of conducting the Research Program. The parties understand that
the Assays will be disclosed to Dainippon only for the purpose of conducting the
Research Program.
(b) SUBLICENSING. Neither party may grant sublicenses under
the licenses granted in subsection (a) above, except in the context of contract
research or contract development by a third party as part of the Research
Program, and then only after the prior written approval of the licensor. The
terms of any sublicense shall conform with the terms of this Agreement in all
respects.
3.3 USE OF A PARTY'S OWN SUBSTANCES. Notwithstanding anything to the
contrary in this Article 3, each party shall retain the right to use freely its
own Dainippon or RiboGene Substances, respectively, which are not Active
Compounds.
3.4 RESEARCH. RiboGene and Dainippon agree that during the period of
the Research Agreement and License Agreement, RiboGene has the right in any
field to use or apply, have its Affiliates use or apply, grant to any third
party a license under RiboGene owned or jointly owned Collaboration Technology
to research, develop, make, have made, use and sell Active Compounds, other than
Licensed Compounds, Licensed Back-Up Compounds and Products; provided, however,
[*]. In addition, [*] agrees [*] or [*] which [*]. If Dainippon notifies
RiboGene that it desires to have the rights and licenses under RiboGene
Technology or RiboGene solely owned Collaboration Technology to sublicense,
research, develop, make, have
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made, use and sell any Active Compound [*] if any, as may be reached at that
time. It is understood that Dainippon [*] use and apply, or have its Affiliates
use and apply or grant to any third party a license under Dainippon owned and
jointly owned Collaboration Technology to research, develop, make, have made,
use and sell Active Compound [*].
ARTICLE 4
FINANCIAL TERMS
4.1 RESEARCH PROGRAM FUNDING. Dainippon shall support RiboGene's
costs of conducting the Research Program by making research payments as follows:
Due Date Amount
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Signing of this Agreement US$2,000,000
First Anniversary of this Agreement US$2,000,000
Second Anniversary of this Agreement US$2,000,000
RiboGene shall provide Dainippon with a statement of the details of RiboGene's
estimated costs of conducting the Research Program prior to the above payment by
Dainippon and quarterly reports describing actual costs and expenses actually
incurred at RiboGene. Any costs incurred by RiboGene during the Tail End Period
for conducting research activities assigned to it by the Research Committee will
be reimbursed by Dainippon. If an installment of the Research Program Funding
would have become due on a date after Dainippon gives notice of termination of
this Agreement pursuant to Section 11.2, then on such date Dainippon shall pay
only such portion of the installment as shall apply to the remaining period of
the Research Term which will occur after such date. If any amount of the
Research Program Funding already paid by Dainippon hereunder is not used for the
Research Program upon termination of this Agreement except for material breach
by Dainippon, such unused amount shall be refunded to Dainippon.
4.2 MANNER OF PAYMENT. Dainippon shall make the payments under
Sections 4.1 within thirty (30) days of the due date by means of wire transfer
to RiboGene's account in a bank in the United States to be designated by
RiboGene.
4.3 EQUITY PURCHASE. Dainippon agrees to purchase $2,000,000 in
equity of RiboGene. Such equity purchase shall be made on or before February 13,
1998, as the purchase of 756,144 shares of RiboGene's Series G Preferred Stock
("Series G Preferred") at a price per share of $2.645. The Series G Preferred
shall have substantially the same terms and conditions and shall be accompanied
by substantially the same investors rights as RiboGene's Series E Preferred
stock purchased by its existing major collaboration partner. The Stock Purchase
Agreement, Amended Articles of Incorporation and Investors Rights Agreement and
forms of closing certificates and related documents shall be prepared and agreed
by Dainippon and RiboGene not later than February 5, 1998.
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ARTICLE 5
PATENT PROSECUTION AND DEFENSE
5.1 PATENT PROSECUTION.
(a) Applications for RiboGene Patents and Dainippon Patents
shall be prosecuted and maintained by RiboGene and Dainippon, respectively, at
such party's option and its own expense. However, RiboGene agrees it will not
discontinue prosecuting or maintaining any such patent or application in any
country of the Territory which covers a Licensed Compound or Product for which
Dainippon has commenced preclinical development in the Territory unless
Dainippon shall otherwise agree.
(b) Each party shall be responsible for filing and
prosecuting applications for its solely-owned Collaboration Patents, and for
maintaining its solely-owned Collaboration Patents, in the Territory. The
Research Committee will decide which party shall prosecute jointly-owned
Collaboration Patents; [*] will bear [*] the cost of prosecuting jointly-owned
patent applications and maintaining jointly-owned Collaboration Patents in the
Territory; provided, however, that [*] shall bear such costs for applications
and patents for any Licensed Compound or Product commencing as of [*]. The
Research Committee also shall determine the countries in which to file
applications for such Collaboration Patents in the Territory.
(c) The prosecuting party shall keep the other party
informed of the status of any applications for Collaboration Patents and any
patents issued thereon. In particular, the prosecuting party shall provide to
the other party a copy of any proposed filings or letters to and from the patent
offices in the countries of the Territory. The other party shall have the right
to review such drafts and letters, and shall provide comments to the prosecuting
party within thirty (30) days after receipt thereof. The prosecuting party shall
consider the other party's comments in good faith and revise the draft filings
or letters as reasonably necessary to address the other party's concerns.
(d) In the event that the prosecuting party decides not to
proceed with prosecuting an application for a Collaboration Patent or filing a
patent application in a country of the Territory, or not to maintain a
Collaboration Patent in a country of the Territory, it shall give the other
party sixty (60) days' notice before any relevant deadline, and the other party
shall have the right to pursue, at its own expense, prosecution of such patent
application or maintenance of such patent in the country, and such patent in the
country shall be excluded from the licenses granted herein or in the License
Agreement. However, RiboGene agrees it will not discontinue prosecuting or
maintaining any such patent or application in any country of the Territory which
covers a Licensed Compound or Product for which Dainippon has commenced
preclinical development in the Territory unless Dainippon shall otherwise agree.
(e) Each party agrees to cooperate with the other and take
all reasonable additional actions and execute such agreements, instruments, and
documents as may be reasonably required to prosecute patent applications as
provided in this section, and to perfect the other's ownership interest in
Collaboration Patents as allocated in Section 3.1, including, without
limitation, the execution of necessary and appropriate instruments of
assignment.
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5.2 INFRINGEMENT OF PATENTS BY THIRD PARTIES. Infringement of
Dainippon Patents, RiboGene Patents or Collaboration Patents by third parties as
well as infringement of third party patents by Dainippon shall be governed by
the provisions of the License Agreement.
ARTICLE 6
PUBLICATION; PUBLICITY
6.1 PUBLICATION.
(a) REVIEW AND APPROVAL. Each party to this Agreement
recognizes that the publication of papers, including oral presentations and
abstracts, regarding the Collaboration Know-How and the Collaboration Patents,
subject to reasonable controls to protect Confidential Information, will be
beneficial to both parties. However, each party shall have the right to review
and approve any paper proposed for publication by the other party, including
oral presentations and abstracts, which utilizes data generated from the
Research Program and/or includes Collaboration Know-How or Confidential
Information of the reviewing party.
(b) REVIEW AND APPROVAL PROCESS. At least thirty (30) days
before any such paper is presented or submitted for publication, the party
proposing publication shall deliver a complete copy to the other party. The
receiving party shall review any such paper and give its comments to the
publishing party within thirty (30) days of the delivery of such paper to the
receiving party. With respect to oral presentation materials and abstracts, the
parties shall make reasonable efforts to expedite review of such materials and
abstracts, and shall return such items as soon as practicable to the publishing
party with appropriate comments, if any, but in no event later than thirty (30)
days from the delivery date thereof to the receiving party. The publishing party
shall comply with the other party's request to delete references to any
Confidential Information in any such paper and agrees to withhold publication of
same in order to permit the parties to obtain patent protection, if either of
the parties deem it necessary, in accordance with the terms of this Agreement.
6.2 PUBLICITY. Except as otherwise provided herein or required by
law, no party shall originate any publication, news release or other public
announcement, written or oral, whether in the public press, or stockholders'
reports, or otherwise, relating to the existence of or the performance under
this Agreement, without the prior written approval of the other party, which
approval shall not be unreasonably withheld, but in no case shall be withheld
for longer than fifteen (15) days.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES
Each party hereby represents and warrants:
7.1 CORPORATE POWER. Such party is duly organized and validly
existing under the laws of the state or country of its incorporation and has
full corporate power and authority to enter into this Agreement and to carry out
the provisions hereof.
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7.2 DUE AUTHORIZATION. Such party is duly authorized to execute and
deliver this Agreement and to perform its obligations hereunder.
7.3 BINDING AGREEMENT. This Agreement is a legal and valid
obligation binding upon it and is enforceable in accordance with its terms. The
execution, delivery and performance of this Agreement by such party does not
conflict with any agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency
having authority over it.
7.4 INTELLECTUAL PROPERTY. Such party (i) has the full right to
grant the licenses granted by it under this Agreement; and (ii) is not aware, to
the best of its knowledge, of any claims by third parties to a conflicting
ownership interest in its solely-owned Patents.
7.5 RIBOGENE DISCLAIMER. THE RIBOGENE TECHNOLOGY, INCLUDING THE
RIBOGENE SUBSTANCES, PROVIDED HEREUNDER, IS PROVIDED "AS IS" AND RIBOGENE
EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN
ALL CASES WITH RESPECT THERETO. Without limiting the generality of the
foregoing, RiboGene expressly does not warrant (i) the success of any study or
test commenced pursuant to the Research Program, or (ii) the safety or
usefulness for any purpose of RiboGene Technology or the Collaboration Know-How.
7.6 DAINIPPON DISCLAIMER. THE DAINIPPON TECHNOLOGY, INCLUDING THE
DAINIPPON SUBSTANCES, PROVIDED HEREUNDER ARE PROVIDED "AS IS" AND DAINIPPON
EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN
ALL CASES WITH RESPECT THERETO. Without limiting the generality of the
foregoing, Dainippon expressly does not warrant the safety or usefulness for any
purpose of the Dainippon Technology or the Collaboration Know-How.
ARTICLE 8
INDEMNIFICATION
8.1 INDEMNIFICATION BY RIBOGENE. RiboGene shall indemnify Dainippon,
its Affiliates and sublicensees, and all their officers, directors, employees
and agents, for any reasonable out-of-pocket costs and expenses (including court
and arbitration costs, witness fees and reasonable attorneys' fees),
non-appealed or non-appealable judicial or arbitration damage awards, and
settlement payments agreed with the third party claimants, payable or owed by
Dainippon in connection with any demands, law suits and other legal actions of
third parties ("Third Party Claim") arising from (i) the performance or breach
of this Agreement or the
12.
13
License Agreement by RiboGene, (ii) any negligent actions or willful misconduct
by RiboGene, its Affiliates, agents or sublicensees, and (iii) the possession,
manufacture, use, sale or administration of Active Compounds, Inactive Derived
Compounds, Licensed Compounds, Licensed Back-Up Compounds or Products by
RiboGene or RiboGene's Affiliates or sublicensees.
8.2 INDEMNIFICATION UNDERTAKING BY DAINIPPON. Dainippon shall
indemnify RiboGene, its Affiliates and sublicensees, and all their officers,
directors, employees and agents, for any reasonable out-of-pocket costs and
expenses (including court and arbitration costs, witness fees and reasonable
attorneys' fees), non-appealed or non-appealable judicial or arbitration damage
awards, and settlement payments agreed with the third party claimants payable or
owed by RiboGene in connection with any Third Party Claim arising from (i) the
performance or breach of this Agreement or the License Agreement by Dainippon,
(ii) any negligent actions or willful misconduct by Dainippon, its Affiliates,
agents or sublicensees, and (iii) the possession, manufacture, use, sale or
administration of Active Compounds, Inactive Derived Compounds, Licensed
Compounds, Licensed Back-Up Compounds or Products by Dainippon or Dainippon's
Affiliates or sublicensees.
8.3 CONDITIONS AND LIMITATIONS OF INDEMNIFICATION OBLIGATION.
(a) In order to maintain the right to be indemnified by the
other party ("Indemnitor"), the party claiming indemnification ("Indemnitee")
must:
(i) notify the Indemnitor promptly after learning of
a Third Party Claim;
(ii) allow the Indemnitor to manage and control (by
way of intervention or otherwise) the defense and/or settlement of any such
Third Party Claim against the Indemnitee;
(iii) cooperate with the Indemnitor in the defense or
the settlement negotiations of Third Party Claims as reasonably required by the
Indemnitor;
(iv) abstain from making any statements or taking any
actions which damage the defense against a Third Party Claim (including, without
limitation, any statements against the interest of the Indemnitee or admissions
of causation or guilt);
(v) submit to the Indemnitor for prior approval
(which shall not be unreasonably withheld) any out-of-pocket expenditures to be
made in connection with the defense against a Third Party Claim.
(b) The Indemnitor shall not agree to any settlement that
adversely affects the Indemnitee's rights or interest without the Indemnitee's
prior written approval (which approval shall not be unreasonably withheld). If
the Indemnitor assumes the control of the defense against a Third Party Claim,
any out-of-pocket costs and expenses of the Indemnitee approved pursuant to
subsection (v) above shall be reimbursed based on an invoice and receipts
showing the payment of such costs and expenses.
13.
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(c) The Indemnitor shall have no obligation to indemnify the
Indemnitee to the extent that a Third Party Claim results from the negligence or
willful misconduct of the Indemnitee.
ARTICLE 9
CONFIDENTIALITY
9.1 DISCLOSURE OF CONFIDENTIAL INFORMATION. Confidential Information
disclosed by one party to the other pursuant to and during the term of this
Agreement shall be subject to the confidentiality obligations set forth below:
(a) if disclosed in writing and marked "confidential" or
"proprietary" by the disclosing party prior to or at the time of the disclosure
thereof, or if it would be apparent to a reasonable person, familiar with the
disclosing party's business and the industry, that such information is of a
confidential or proprietary nature; and
(b) if within 30 days after disclosure of Confidential
Information, the disclosing party informs the receiving party in writing of the
confidential nature of the disclosed information, describing such information
and referencing the place and date of the oral, visual or written disclosure and
the names of the employees or officers of the receiving party to whom such
disclosure was made.
9.2 CONFIDENTIALITY AND NON-USE. Except to the extent expressly
authorized by this Agreement or unless otherwise agreed in writing by the
parties, each party agrees that, for the combined term of this Agreement and the
License Agreement, and for [*] thereafter, it shall keep confidential and shall
not publish or otherwise disclose and shall not use for any purpose other than
as provided for in this Agreement any Confidential Information, unless the
receiving party can demonstrate by competent proof that such Confidential
Information:
(a) was already known to the receiving party, other than
under an obligation of confidentiality, at the time of disclosure by the other
party;
(b) was generally available to the public or otherwise part
of the public domain at the time of its disclosure to the receiving party;
(c) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the receiving party in breach of such Agreements;
(d) was disclosed to the receiving party, other than under
an obligation of confidentiality to a third party, by a third party who had no
obligation to the disclosing party not to disclose such information to others;
or
(e) was independently discovered or developed by the
receiving party without the use of Confidential Information belonging to the
disclosing party.
14.
15
9.3 AUTHORIZED DISCLOSURE.
(a) Each party may disclose Confidential Information
belonging to the other party to Affiliates and sublicensees who agree to be
bound by similar terms of confidentiality. In addition, each party may disclose
Confidential Information of the other party to the extent such disclosure is
reasonably necessary to: (i) comply with applicable securities laws and
regulations and other applicable governmental regulations, (ii) file or
prosecute patents relating to Collaboration Technology, (iii) prosecute or
defend litigation, (iv) file applications for Regulatory Approvals for Active
Compounds, Licensed Back-Up Compounds, Licensed Compounds and Products, and (v)
conduct pre-clinical or clinical trials with Active Compounds, Licensed
Compounds and Products.
(b) Notwithstanding the foregoing, in the event a party is
required to make a disclosure of the other party's Confidential Information
pursuant to subsection (a) above, it will, except where impracticable, give
reasonable advance notice to the other party of such disclosure and use best
efforts to secure confidential treatment of such information. In any event, the
parties agree to take all reasonable action to avoid disclosure of Confidential
Information hereunder.
ARTICLE 00
XXXXXX XXX XXXXXX XXXXXXXX
00.0 XXXXXX XXXXXX LAWS. The parties understand and acknowledge that
each of them is subject to regulation by agencies of the U.S. government,
including the U.S. Department of Commerce, which prohibit export, re-export or
diversion of certain products and technology to certain countries. Any and all
obligations of Dainippon or RiboGene to provide access to or license any
technology pursuant to this Agreement, as well as any technical assistance shall
be subject in all respects to such United States laws and regulations as shall
from time to time govern the license and delivery of technology and products
abroad by persons subject to the jurisdiction of the United States, including
the Export Administration Act of 1979, as amended, any successor or interim
controlling legislation, and the Export Administration Regulations issued by the
Department of Commerce, International Trade Administration, Bureau of Export
Administration. Both parties also agree to comply with the requirements of the
U.S. Foreign Corrupt Practices Act (the "ACT") and shall refrain from making any
payments to third parties which would cause Dainippon or RiboGene to violate the
Act. Dainippon and RiboGene shall each provide the other party with such
reasonable assistance as may be required for the party requesting such
assistance to comply with all United States laws, ordinances, rules, regulations
and the like of all governmental units or agencies having jurisdiction
pertaining to this Agreement, including without limitation, obtaining all
import, export and other permits, certificates, licenses or the like required by
such United States laws, ordinances, rules, regulations and the like, necessary
to permit the parties to perform hereunder and to exercise their respective
rights hereunder.
10.2 NON-UNITED STATES LAWS. Dainippon and RiboGene shall each
provide the other party with such reasonable assistance as may be required for
the party requesting such assistance to comply with all non-United States laws,
ordinances, rules, regulations and the like of all governmental units or
agencies having jurisdiction pertaining to this Agreement, including without
15.
16
limitation, obtaining all import, export and other permits, certificates,
licenses or the like required by such non-United States laws, ordinances, rules,
regulations and the like, necessary to permit the parties to perform hereunder
and to exercise their respective rights hereunder.
ARTICLE 11
TERM; TERMINATION
11.1 TERM. This Agreement shall expire at the end of the Tail End
Period following the Research Term; provided, however, that Dainippon shall have
the option to forego the Tail End Period and terminate the Research Program at
the end of the Research Term by giving thirty (30) days prior written notice to
RiboGene.
11.2 VOLUNTARY TERMINATION BY DAINIPPON. Dainippon may give notice of
termination of this Agreement at any time after one (1) year from the Effective
Date which notice shall be effective one hundred eighty (180) days' after the
date received by RiboGene. Dainippon shall reimburse RiboGene for the costs of
any activities pursuant to the Research Program for which obligations were
undertaken prior to receipt of such notice and which are incurred during or
after the one hundred eighty (180) days period to the extent that such costs are
not covered by the Research Program Funding already paid by Dainippon at that
time pursuant to Section 4.1. If Dainippon terminates this Agreement pursuant to
this Section 11.2, all rights and licenses to Active Compounds, Licensed
Compounds, Licensed Back-Up Compounds, RiboGene Technology and Collaboration
Technology granted to Dainippon under this Agreement or the License Agreement
shall terminate.
11.3 TERMINATION FOR MATERIAL BREACH. If either party materially
breaches this Agreement, including, without limitation, its due diligence
obligations under Section 2.7, and the breaching party has not within sixty (60)
days of notice of breach from the non-breaching party (i) cured the breach or
(ii) initiated good faith efforts to cure such breach to the reasonable
satisfaction of the non-breaching party, the non-breaching party may terminate
this Agreement upon expiration of such sixty (60)-day period.
11.4 LICENSES UPON TERMINATION FOR MATERIAL BREACH. In the event this
Agreement is terminated by Dainippon based on a material breach by RiboGene,
then RiboGene's license and rights shall terminate and Dainippon shall have a
perpetual, paid-up exclusive worldwide license under RiboGene Technology and
RiboGene owned and jointly owned Collaboration Technology to research, develop,
make, have made, use and sell any Active Compound in any field. In the event
this Agreement is terminated by RiboGene based on a material breach by
Dainippon, then Dainippon's license and rights shall terminate and RiboGene
shall have a perpetual, paid-up exclusive worldwide license under Dainippon
Technology and Dainippon owned and jointly owned Collaboration Technology to
research, develop, make, have made, use and sell any Active Compound in any
field.
11.5 LICENSES AFTER EXPIRATION OR TERMINATION. If upon expiration or
termination of this Agreement other than due to breach by RiboGene, Dainippon
has not developed at least one (1) Licensed Compound, or if such development
terminates during pre-clinical or clinical studies RiboGene shall have a
perpetual exclusive royalty-bearing worldwide license under Dainippon solely
owned Collaboration Technology to
16.
17
research, develop, make, have made, use and sell any Active Compound and to use
and apply non-compound related Collaboration Technology in the Field.
11.6 SURVIVING RIGHTS. The obligations and rights of the parties
under Sections 3.1, 3.3, 3.4, 4.1, 11.4, 11.5, 11.8, 12.6, and Articles 5, 6, 7,
8, and 9 shall survive expiration or termination of this Agreement.
11.7 ACCRUED RIGHTS; SURVIVING OBLIGATIONS. The termination,
relinquishment or expiration of the Agreement for any reason shall be without
prejudice to any rights which shall have accrued to the benefit of either party
prior to such termination, relinquishment or expiration, including any damages
arising from any breach hereunder.
11.8 TERMINATION FOR BANKRUPTCY. To the extent permitted by law, in
the event either party becomes insolvent, files bankruptcy or is declared
bankrupt, the other party may terminate this Agreement immediately; provided,
however, in the event of such termination the insolvent or bankrupt party shall
assign to the other the intellectual property rights licensed under this
Agreement subject only to the payment of any royalties agreed herein with
respect to such intellectual property.
ARTICLE 12
MISCELLANEOUS
12.1 WAIVER. No waiver by either party hereto of any breach or
default of any of the covenants or agreements herein set forth shall be deemed a
waiver as to any subsequent or similar breach or default.
12.2 ASSIGNMENT. Neither party shall assign any of its rights and
obligations hereunder except (i) as incident to the merger, consolidation,
reorganization or acquisition of stock affecting actual voting control or of
substantially all of the assets of the assigning party or (ii) to an Affiliate;
provided, however, that in no event shall either party's rights and obligations
hereunder be assigned without prior written notice to the other party. In any
case, neither party may make an assignment of its assets which renders it unable
to perform its material obligations hereunder. This Agreement shall be binding
upon and inure to the benefit of the parties hereto and their permitted
successors and assigns.
12.3 NOTICES. Any notice or other communication required or permitted
to be given to either party hereto shall be in writing and shall be deemed to
have been properly given and to be effective on the date of delivery if
delivered in person or by facsimile or fourteen (14) days after mailing by
registered or certified airmail, postage paid, to the other party at the
following address:
17.
18
In the case of RiboGene: RiboGene, Inc.
00000 Xxxxxxxx Xxxx
Xxxxxxx, XX 00000
Fax: (000) 000-0000
Attention: President
with a copy to: Cooley Godward LLP
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Fax: (000) 000-0000
Attention: Xxxxx X. Xxxxxxxxxx, Esq.
In the case of Dainippon: Dainippon Pharmaceuticals Co., Ltd..
0-0 Xxxxxxxxxx 0 xxxxx, Xxxx-xx
Xxxxx 000-0000
Xxxxx
Fax: 000 00 0 000 0000
Attention: President
Either party may change its address for communications by a notice to the other
party in accordance with this section.
12.4 HEADINGS. The headings of the several sections are inserted for
convenience of reference only and are not intended to be a part of or to affect
the meaning or interpretation of this Agreement.
12.5 AMENDMENT. No amendment or modification hereof shall be valid or
binding upon the parties unless made in writing and signed by both parties.
12.6 CONSTRUCTION OF AGREEMENT AND CHOICE OF LAW; RESOLUTION OF
DISPUTES.
(a) This Agreement and its terms and conditions shall be
governed exclusively by and construed according to the laws of California,
U.S.A., excluding its choice of law provisions and also excluding the United
Nations Convention on Contracts for the International Sale of Goods. The
official text of the Agreement and any notices given or accounts or statements
required hereby shall be in English.
(b) All disputes which may arise between the parties hereto
in relation to the interpretation or administration of this Agreement shall be
first referred to the Research Committee for resolution. Any disputes which the
Research Committee is unable to resolve within a reasonable period of time shall
be resolved by the agreement of the Chief Executive Officers or the Presidents
of the respective parties.
(c) Any disputes which cannot be resolved in this manner
shall be finally settled by arbitration in accordance with the Conciliation and
Arbitration Rules of the
18.
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International Chamber of Commerce. The arbitration shall be held in San
Francisco. The award rendered by the arbitration shall in any case be final and
binding upon the parties hereto.
12.7 FORCE MAJEURE. Any delays in performance by any party under this
Agreement shall not be considered a breach of this Agreement if and to the
extent caused by occurrences beyond the reasonable control of the party
affected, including but not limited to acts of God, embargoes, governmental
restrictions, strikes or other concerted acts of workers, fire, flood,
explosion, riots, wars, civil disorder, rebellion or sabotage. The party
suffering such occurrence shall immediately notify the other party as soon as
practicable and any time for performance hereunder shall be extended by the
actual time of delay caused by the occurrence.
12.8 INDEPENDENT CONTRACTORS. In making and performing this
Agreement, Dainippon and RiboGene are, and shall act at all times as independent
contractors and nothing contained in this Agreement shall be construed or
implied to create an agency, partnership or employer and employee relationship
between RiboGene and Dainippon. At no time shall one party make commitments or
incur any charges or expenses for or in the name of the other party.
12.9 SEVERABILITY. If any term, condition or provision of this
Agreement is held to be unenforceable for any reason, it shall, if possible, be
interpreted rather than voided, in order to achieve the intent of the parties to
this Agreement to the extent possible. In any event, all other terms, conditions
and provisions of this Agreement shall be deemed valid and enforceable to the
full extent.
12.10 CUMULATIVE RIGHTS. The rights, powers and remedies hereunder
shall be in addition to, and not in limitation of, all rights, powers and
remedies provided at law or in equity, or under any other agreement between the
parties. All of such rights, powers and remedies shall be cumulative, and may be
exercised successively or cumulatively.
12.11 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document.
12.12 ENTIRE AGREEMENT. This Agreement and any Exhibits referred to
herein embodies the final and complete understanding of the parties with respect
to the subject matter hereof and shall supersede all previous communications,
representations or understandings, either oral or written, between the parties
relating to the subject matter hereof.
19.
20
IN WITNESS WHEREOF, both Dainippon and RiboGene have executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, as of the day and year hereinabove written.
RIBOGENE, INC. DAINIPPON PHARMACEUTICAL CO., LTD.
By: By:
--------------------------------- ------------------------------------
Name: Xxxxxxx X. Xxxxxxxxx Name: Takeshi Tomotake
Title: Chairman, President and Title: President
Chief Executive Officer
20.
21
EXHIBIT 1.1
CRITERIA FOR ACTIVE COMPOUNDS
[*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
i.
22
EXHIBIT 1.3
ASSAYS
[*]
[*]
[*]
[*]
[*]
[*]
[*]
i.
23
EXHIBIT 1.23
RESEARCH PROGRAM
RiboGene Responsibility
[*]
Joint Responsibility
[*]
Dainippon Responsibility
[*]
ii.
24
EXHIBIT 1.23 (CONTINUED)
TIME FRAME
[*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
iii.
25
EXHIBIT 1.23 (continued)
RiboGene Resources
RiboGene anticipates [*] during the Research Term. The [*] approximately as
follows over the term of the Research Program.
Annual Breakdown:
[*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
[*] [*] [*] [*]
iv.
26
EXHIBIT 2.3
CRITERIA FOR LICENSED COMPOUNDS
Criteria for Licensed Compounds will be determined by the Research Committee and
will be decided based on [*]. The following criteria [*] :
[*]
v.
