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Exhibit 10.2
ABBOTT-RIBOGENE RESEARCH AGREEMENT
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Table of Contents
Page
I. DEFINITIONS ..................................................5
1.1 Abbott Compound ..........................................5
1.2 Affiliate ................................................6
1.3 Annual Research Plan .....................................7
1.4 Beneficiary Party ........................................7
1.5 Collateral Party .........................................7
1.6 Contract Year and Contract Quarter .......................7
1.7 Field ....................................................7
1.8 FTE ......................................................8
1.9 Independent Information ..................................8
1.10 Joint Management Team or JMT .............................9
1.11 Know-how .................................................9
1.12 License Agreement .......................................10
1.13 Product .................................................10
1.14 Program Information .....................................10
1.15 Program Inventions and Joint Program Inventions .........11
1.16 Research Program or Program .............................11
1.17 Research Term ...........................................12
1.18 RiboGene Compound .......................................12
1.19 RiboGene Intellectual Property ..........................12
1.20 RiboGene Lead ...........................................13
1.21 RiboGene Patent Rights ..................................13
II. RESEARCH ACTIVITIES ........................................14
2.1 RiboGene Efforts ........................................14
2.2 Abbott Efforts ..........................................14
2.3 Conflict In Terms .......................................14
2.4 Allocation of Resources .................................14
2.5 Laboratory Records ......................................15
2.6 Reporting and Access ....................................15
2.7 Compliance ..............................................15
2.8 Binding Effect ..........................................15
2.9 Exclusivity .............................................15
2.10 Exception to Exclusivity ................................16
III. OVERSIGHT OF THE RESEARCH PROGRAM .........................17
3.1 JMT Duties ..............................................17
3.2 JMT Composition .........................................17
3.3 RiboGene Representatives ................................18
3.4 Meetings ................................................18
3.5 Decision Making .........................................19
3.6 Annual Research Plan ....................................19
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IV. RESEARCH SUPPORT ...........................................19
4.1 Abbott Funding ..........................................19
4.2 Control .................................................20
V. CONFIDENTIALITY OF INDEPENDENT AND PROGRAM INFORMATION ......20
5.1 Confidentiality and Nonuse ..............................20
5.2 Required Disclosure .....................................21
5.3 Return of Independent and Program Information ...........21
5 4 Program Information .....................................22
5.5 Nondisclosure of Third Party Confidential Information....23
5.6 Publicity ...............................................23
5.7 Permitted Disclosure ....................................23
5.8 Publications ............................................23
VI. RIGHTS TO PROGRAM INVENTIONS ...............................24
6.1 Disclosure of Inventions ................................24
6.2 Determination of Inventorship ...........................24
6.3 First Assignment of Rights ..............................24
6.4 Alternate Assignment of Rights ..........................25
6.5 ownership Rights ........................................29
6.6 Invention Use During the Research Term ..................29
6.7 Invention Rights Following the Research Term ............29
VII. WARRANTIES AND LIMITATIONS ON RIGHTS ......................30
7.1 RiboGene Warranties .....................................30
7.2 Limitation on Warranties ................................31
7.3 Disclaimer ..............................................31
7.4 Limitations on Rights ...................................31
VIII. LIABILITIES AND INDEMNITY ................................32
8.1 Liabilities .............................................32
8.2 Indemnification .........................................32
IX. TERM AND TERMINATION .......................................33
9.1 Term ....................................................33
9.2 Possible Extension ......................................33
9.3 Termination Without Breach ..............................33
9.4 Effect of Breach ........................................34
9.5 Effect of Bankruptcy or Agreement Revision ..............34
9.6 Consequences of Termination .............................35
X. MISCELLANEOUS ...............................................35
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10.1 Notices .................................................35
10.2 Independence of Parties .................................36
10.3 Impact on Other Relationships ...........................36
10.4 No Third-Party Beneficiaries ............................36
10.5 No Waiver ...............................................37
10.6 Merger Clause ...........................................37
10.7 Alternative Dispute Resolution ..........................37
10.8 Headings ................................................42
10.9 Governmental Compliance and Effect of Invalidity ........42
10.10 Assignability ...........................................42
10.11 Succession ..............................................43
10.12 Government Compliance ...................................43
10.13 Governing Law ...........................................43
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RESEARCH AGREEMENT
This Research Agreement ("Agreement") is entered into effective as of
April 26, 1996 (the "Effective Date") by and between RiboGene, Inc., a
California corporation with a principal place of business at 00000 Xxxxx
Xxxxxxxxx, Xxxxxxx, Xxxxxxxxxx 00000 ("RiboGene") and Xxxxxx Laboratories, an
Illinois corporation with a principal place of business at 000 Xxxxxx Xxxx Xxxx,
Xxxxxx Xxxx, Xxxxxxxx 00000-0000 ("Abbott").
WHEREAS, RiboGene is experienced in translation biochemistry, particularly
in eukaryotic translation mechanisms, and in screening compounds and materials
for fungicidal and fungistatic activity, and owns or has exclusive licenses to a
number of compounds already identified as possessing such activity, and Abbott
is experienced in the discovery and development of small molecule pharmaceutical
products, including those with antifungal properties, and in obtaining
regulatory approval for and in commercializing such pharmaceutical products; and
WHEREAS, the parties desire to collaborate in a Research Program (as
defined hereinbelow) directed to accelerating the discovery of new
pharmaceutical and/or agricultural products possessing antifungal activity
and/or new diagnostic products related to conditions caused by fungal Infections
and/or diseases, and to provide for a license to Abbott for the evaluation and
possible development and eventual commercialization of such products.
NOW THEREFORE, in consideration of the mutual covenants and promises
contained herein, Abbott and RiboGene agree as follows:
I. DEFINITIONS
1.1 "Abbott Compound" shall mean any synthetic chemical compound or
biological material, which compound or material:
A. is represented in compound libraries/collections owned or controlled
by Abbott and/or Abbott Affiliate (where "Affiliate" Is defined hereinbelow) as
of the Effective Date, whether or not the same compound or material is
represented in compound libraries/collections owned or controlled by RiboGene
and/or RiboGene Affiliate as of the Effective Date;
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or
B. is acquired by or prepared by Abbott independently of the Research
Program; or
C. is acquired or prepared by Abbott under the Research Program,
including any analog of any RiboGene Compound (as defined hereinbelow) prepared
by Abbott, but excluding any RiboGene Compound prepared by Abbott; or
D. is discovered or identified by or for Abbott based on criteria
developed under the Research Program; which, in each case:
(a) demonstrates antifungal activity during the Research Program
using RiboGene's translation inhibition screening assays, or using other
translation or non-translation inhibition screening assay(s) developed under the
Research Program, as the principal enabling screen; and
(b) demonstrates a [*] or higher IC(5O) value in a mammalian in
vitro translation assay than that demonstrated in a fungal in vitro translation
assay, each assay existing at RiboGene as of the Effective Date, or demonstrates
similar selectivity advantage in another in vitro assay, developed by one party
or both parties during the Research Term (as defined hereinbelow) or agreed upon
by the JMT, over a measure from a corresponding mammalian assay; and
(c) demonstrates an MIC (less than or equal to) [*] agreed upon by
the JMT;
E. is any salt, ester, amide, complex, chelate, hydrate, isomer,
stereoisomer, crystalline or amorphous form, prodrug, metabolite, metabolic
precursor, or analog of any of the above-included compounds or materials.
Abbott Compound does not include a compound or material provided to Abbott by
RiboGene under the Material Transfer Agreement between RiboGene and Abbott
effective June 7, 1995.
1.2 "Affiliate" shall mean, with respect to either party, any
legally-distinct corporation, firm, individual, or other form of business
organization, which directly or indirectly owns, controls, is controlled by, or
is under common control with, a party hereto. An entity shall be regarded as
being in control of another entity if the former entity has the direct or
indirect power to order or cause the direction of the policies of
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the other entity, whether through ownership of fifty percent (50%) or more in
the United States or thirty percent (30%) or more outside the United States of
the outstanding voting securities of that entity, through other dominant equity
ownership, or by contract, statute, regulation, or otherwise.
1.3 "Annual Research Plan shall mean the statement of objectives for
the activities of RiboGene and Abbott under the Research Program for the
particular Contract Year (as defined hereinbelow), and the reasonably-detailed
description of and timetable for the research activities planned for such
Contract Year, consistent with and designed to accomplish the goals of the
Research Program that is to be conducted during that particular Contract Year,
which is prepared by RiboGene and Abbott, and reviewed and revised and/or
approved by the Joint Management Team (as defined hereinbelow). The Annual
Research Plan for the first Contract Year shall be attached hereto as Exhibit I,
with subsequent Annual Research Plan s being attached hereto as Exhibits II, III
and so forth, as appropriate, upon approval of such Annual Research Plans by the
Joint Management Team.
1.4 "Beneficiary Party" shall mean the party, or possibly parties
according to the provisions of Section 6.4, to this Agreement to which is
assigned or licensed a Program Invention or Joint Program Invention, according
to the provisions of Section 6.3 or Section 6.4.
1.5 "Collateral Party" shall mean the party to this Agreement which can
use a Program Invention for purposes of this Agreement, but to which such
Program Invention is not assigned or licensed for use thereafter.
1.6 "Contract Year" shall mean any consecutive twelve (12)-month period
commencing on the Effective Date, or commencing on any twelve (12)-month
anniversary of such date, during the Research Term. "Contract Quarter" shall
mean a three (3)-month period commencing on the Effective Date or on any three
(3)-month anniversary of such date, during the term of this Agreement.
1.7 "Field" shall mean the treatment, mitigation, cure,
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prevention, detection, and/or monitoring of mycotic (fungal) infections or
diseases, not including those caused by Pneumocystis carinii, in humans, animals
and/or plant protection.
1.8 "FTE" means the time and work output equivalent to one full-time
employee who is proficient in the performance of all assigned duties and
responsibilities.
1.9 "Independent Information" shall mean all valuable, confidential
technical and commercial information, know-how or trade secrets, including all
proprietary scientific and other information or samples which either party has
prior to, or may independently develop or obtain during the term of, this
Agreement that is not obtained as a result of the Research Program, such as
research and business capabilities and strategies, drug targets, ligands,
related research, development plans, or other information related to that party,
possibly including but not necessarily limited to Know-how (as defined
hereinbelow), research methodologies, protocols, receptors, receptor agonists or
antagonists, modulators of transcription factors, screening and testing assays
patent applications not yet published, commercialization plans, independent
research activities or strategies, safety and toxicity results, pharmacological
or pharmacokinetic data, formulation and process information, medical uses,
delivery mechanisms, or other information, data or plans, provided by the party
originally possessing the information ("Disclosing Party") to the other party
("Receiving Party"), which technical or business information:
(a) is in writing or in other physical form, marked
"Confidential", or
(b) is disclosed originally by the Disclosing Party orally,
visually or in some other form and identified as confidential, then subsequently
summarized and reduced to a reasonably-detailed writing or to another physical
form, marked "Confidential and delivered to the Receiving Party within one (1)
month from the original date of disclosure; but shall not include information
which:
(c) is in or comes into the public domain without breach of this
Agreement; or
(d) can be shown to have been known to or subsequently
independently developed by or for the Receiving Party without benefit of
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the Disclosing Party's Independent Information; or
(e) is properly provided to the Receiving Party, without
restriction, by an independent third party under no obligation of
confidentiality to the Disclosing Party; or
(f) is disclosed by the original Disclosing Party on a
nonconfidential basis to any independent third party.
1.10 "Joint Management Team" or "JMT" shall mean a committee consisting
of three (3) official representatives appointed by each party hereto that shall
be the primary vehicle for oversight, coordination and modification of the
Annual Research Plans and recommendation(s) of resource reallocations in order
to better meet the objectives of the Research Program.
1.11 "Know-how" shall mean any and all nonpatented technical data,
drawings, documentation, and other information, in each case relating in some
way to the Field, which is owned by RiboGene as of the Effective Date or is
independently generated, acquired or licensed, with the right to sublicense, by
RiboGene during the term of this Agreement and which is not included in
published patent applications and/or issued patents within RiboGene Patent
Rights (as defined hereinbelow). Know-how may relate to protein translation
(i.e., protein synthesis and mRNA translation), fungal genetics, RNA stability,
the identification and use of pathogen-specific targets, high throughput
screening assays, characteristics of desirable translation inhibitors, or the
development, formulation or marketing thereof, and may include, without
limitation:
(a) research techniques and equipment and modifications thereto,
protocols, processes, and results;
(b) chemical, toxicological, pharmacological, and preformulation
properties of compounds or materials independently owned by or licensed to
RiboGene prior to the Research Program and other translation Inhibitors; and
(c) preclinical data and other information relating to the safety
or efficacy of compounds or materials independently owned by or licensed to
RiboGene prior to the Research Program.
Know-how shall include nonpatented Program information exclusively assignable to
RiboGene according to the provisions of Section 5.4, Section
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6.3 and/or Section 6.4, except for Program Inventions for which Abbott does
not have a nonexclusive license, according to the provisions of Section 6.4.
Know-how shall not include Program Information assignable to or nonexclusively
licensed by Abbott according to the provisions of Section 5.4, Section 6.3
and/or Section 6.4.
1.12 "License Agreement" shall mean the License Agreement between Abbott
and RiboGene of even date which, inter alia, conveys rights to RiboGene
Compounds and to the benefits of RiboGene Intellectual Property.
1.13 "Product" shall mean (a) any pharmaceutical formulation(s)
containing one or more RiboGene Leads and/or Abbott Compounds, which is/are
intended and promoted for human or animal use; or (b) a diagnostic product
comprising one or more Abbott Compounds and/or RiboGene Leads, that is intended
and promoted for the detection and/or monitoring of mycotic infections or
diseases in humans, animals or plant protection; or (c) a plant protection
formulation comprising one or more Abbott Compounds and/or RiboGene Leads, that
is intended and promoted for the treatment, cure or prevention of mycotic
diseases or infections in plants.
1.14 "Program Information" shall mean valuable technical or other
information, which is solely or jointly generated as a direct result of the
Research Program, including, but not necessarily limited to, Annual Research
Plans, mechanisms of action, screening methodologies, patent applications not
yet published, translation inhibitor characteristics, new Abbott Compounds, the
identity of or other Program-generated information related to RiboGene
Compounds, efficacy and toxicity results, bioavailability data, formulation and
process information, delivery mechanisms, know-how and/or ideas, which
information:
(a) is in writing or in other physical form, dated and marked
"Program Information"; or
(b) is disclosed originally by a party hereto orally, visually or
in another form and identified as Program Information, then subsequently
summarized and reduced to a writing or to another physical form, marked "Program
Information", and delivered to the other party hereto within one (1) month from
the original date of disclosure; or
(c) which should reasonably be kept confidential, at least until
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Abbott can make a decision about its commercial relevance and/or value; but
shall not include information which:
(d) is in or comes into the public domain without breach of this
Agreement; or
(e) can be shown to have been known to or is subsequently
independently developed by the Collateral Party without benefit of the Program
Information; or
(f) Is properly provided, without restriction, to the party
claiming exception to Program Information treatment, according to the provisions
of Section 5.4, by an independent third party which has not obtained such
information under an obligation of confidentiality to one of the parties.
1.15 "Program Inventions" shall mean all inventions, innovations,
improvements, ideas, discoveries, technology, know-how, methods, applications
and products (whether or not patentable) arising under the Research Program,
which are conceived, derived, reduced to practice, made or developed during the
term of and the four (4) months following conclusion of the Research Program by
one or more individuals who are employees of one of the parties at the time of
the inventive contribution of such individual(s). "Joint Program Inventions"
shall mean all inventions, innovations, improvements, ideas, discoveries,
technology, know-how, methods, applications and products (whether or not
patentable) arising under the Research Program, which are conceived, derived,
reduced to practice, made or developed during the term of and the four (4)
months following the conclusion of the Program by at least two individuals, at
least one individual of which is an employee, at the time of the inventive
contribution of such individual, of one of the parties hereto, and at least one
individual of which is an employee, at the time of the inventive contribution of
such individual, of the other party hereto.
1.16 "Research Program or "Program" shall mean collaborative research
activities between Abbott and RiboGene, based on RiboGene Intellectual Property,
as revised and/or extended by Program Inventions and/or Joint Program
Inventions; that are directed to the discovery and development of novel broad
spectrum antifungal compounds of clinical and commercial value in the Field. The
Research Program does not include either activities within Xxxxxx'x cell wall
inhibition antifungal program
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or any other non-translation inhibition-based antifungal program within Abbott
or activities within RiboGene's research targeted specifically to Pneumocystis
carinii infections or diseases.
1.17 "Research Terms" shall mean a period of three (3) Contract Years,
unless otherwise terminated according to the provisions of Article IX below or
extended by mutual written consent of the parties.
1.18 "RiboGene Compound" shall mean any synthetic chemical compound or
biological material that has demonstrated antifungal activity according to
RiboGene's translation inhibition screening assays, which
A. is either owned by or licensed, with permission to sublicense, to
RiboGene as of the Effective Date, including but not limited to a compound or
material provided to Abbott by RiboGene under the provisions of the Material
Transfer Agreement between RiboGene and Abbott effective June 7, 1995; or
B. is in-licensed by, with the right to sublicense, or acquired, by
RiboGene during the Research Term and which does not correspond to an Abbott
Compound within Xxxxxx'x or an Abbott Affiliate's libraries/collections prior to
the date of acquisition by RiboGene;
C. is any salt, ester, amide, complex, chelate, hydrate, isomer,
stereoisomer, crystalline or amorphous form, prodrug, metabolite, metabolic
precursor, or analog of any of the above-included compounds or materials.
A RiboGene Compound does not include a compound or material defined as an Abbott
Compound according to the provisions of Section 1.1, or any compound licensed to
RiboGene pursuant to an agreement, effective September, 1993, among RiboGene,
Pharm-Eco Laboratories, Inc. and the University of North Carolina.
1.19 "RiboGene Intellectual Property" shall mean RiboGene Patent Rights
(as defined hereinbelow) and Know-how, as well as Program inventions and/or
Joint Program Inventions assigned exclusively to RiboGene according to the
provisions of Section 6.3 and Program Inventions and/or Joint Program
Inventions exclusively assigned to RiboGene and for which Abbott has a
nonexclusive license, according to the provisions of Section 6.4, or extensions
or revisions of any of the
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above based on jointly-assigned Joint Program Inventions according to the
provisions of Section 6.4.
1.20 "RiboGene Lead" shall mean a RiboGene Compound which (a) in the
judgment of the JMT under the Research Program, demonstrates selective fungal
translation inhibition according to RiboGene's mycotic in vitro translation
assays and mammalian in vitro translation assays; and (b) demonstrates an MIC
less than or equal to [*] agreed upon by the JMT; and (c) has a chemical
structure amenable to modification through medicinal or combinatorial chemistry,
as judged by the JMT. A compound or material shall cease to be a RiboGene Lead
if, after [*] following the termination or expiration of the Research Term,
Abbott has not identified such compound or material to RiboGene as among the up
to [*] RiboGene Leads that Abbott has selected as being those to which Abbott
desires to retain exclusive rights, to the extent RiboGene can grant such
exclusive rights.
1.21 "RiboGene Patent Rights" shall mean all patent applications and
patents in any country of the world, which relate in some way to the Field and
are exclusively owned by or licensed, with the right to sublicense (which right
RiboGene shall make every reasonable effort to obtain), to RiboGene during the
term of this Agreement and during the six (6)-month period thereafter. RiboGene
Patent Rights cover one or more compounds or materials useful in the Field, the
preparation and/or use thereof, or other compositions and/or technology useful
in the Research Program, and include all divisions, continuations,
continuations-in-part, additions, registrations, confirmations, renewals,
extensions, supplemental protection certificates, reexaminations and reissues of
the above patent applications and patents. RiboGene Patent Rights include patent
applications and patents assigned to RiboGene according to the provisions of
Section 6.3, but do not include patent applications and patents assigned to
RiboGene according to the provisions of Section 6.4, in which Abbott has a
nonexclusive license, under the provisions of Section 6.4. RiboGene Patent
Rights include, but are not necessarily limited to, those identified in Exhibit
A attached to this Research Agreement, and updated by RiboGene, as justified by
filing, prosecution, issuance and/or maintenance circumstances, and reattached
hereto.
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II. RESEARCH ACTIVITIES
2.1 RiboGene Efforts RiboGene shall use all reasonable efforts to
expeditiously perform its part of the Research Program substantially in
accordance with the terms and conditions of this Agreement, including the
descriptions and timetables of the Annual Research Plans and any additional
specifications as may be proposed by the JMT and agreed upon in writing by the
parties hereto from time to time during the Research Term.
2.2 Abbott Efforts Abbott shall expend at least [*] per year in support
of its own activities under the Research Program, in addition to its separate,
but related support of RiboGene's activities, according to the provisions of
Section 4.1; shall identify, at its sole option, and permit RiboGene to use
pertinent Abbott technology, only during the Research Term, and only for
purposes of the Program; and will provide to RiboGene such of its research data,
results and conclusions which it deems necessary to accomplish the objectives of
the Research Program.
2.3 Conflict in Terms In the event of a conflict between the Annual
Research Plans and this Agreement, the terms and conditions of this Agreement
shall control.
2.4 Allocation of Resources RiboGene shall allocate sufficient
resources and effort to carry out its obligations under the Research Program.
RiboGene shall assign not fewer than eight (8) FTE scientific personnel,
identified to Abbott, comprising at least three (3) Ph.D. or M.D. and the
remainder at least Bachelor of Science qualified researchers, with the aggregate
skills and experience, and shall obtain and/or dedicate sufficient equipment and
facilities, to fulfill the expectations that the parties have for the Program.
RiboGene shall promptly inform Abbott of any changes in the assignments of any
such FTE's and shall promptly add or substitute individuals of comparable or
superior skills into the Program in place of one or more of the original FTE's,
as circumstances dictate, and shall apprise Abbott, in advance, of all such
plans.
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2.5 Laboratory Records RiboGene shall keep and maintain detailed
records of its research and screening activities and laboratory data generated
in the course of or otherwise in connection with the Research Program in order
for RiboGene to furnish complete and accurate information to the Joint
Management Team and Abbott, to the extent necessary for RiboGene to fulfill its
obligations under the Research Program. RiboGene shall permit Abbott to have
reasonable access to such records, and to facilities where RiboGene's research
and screening under the Research Program is being conducted, upon reasonable
notice and during regular business hours. All information obtained as a result
of such access shall be treated as RiboGene's Independent Information or as
Program Information, as the case may be.
2.6 Reporting and Access During the term of this Agreement, each party
shall frequently communicate with the other on the progress of and results
achieved in the Research Program; and may be required by the JMT to provide all
representatives and alternates, if applicable, to the JMT, at such times as
determined by and in a format agreed upon by the JMT, with detailed written
reports of its activities under the Program, as well as the data and results
obtained by it in connection with the Research Program.
2.7 Compliance Each party shall conduct its part of the Research
Program in compliance with all federal, state and local laws, ordinances,
regulations, standards and guidelines applicable thereto, including but not
limited to all applicable environmental regulations and guidelines.
2.8 Binding Effect Each party's employees involved in the Research
Program shall be bound as employees of that party by all confidentiality and
invention-assignment terms of this Agreement.
2.9 Exclusivity During the Research Term, including any extension
thereof, and for six (6) months thereafter, subject to the provisions of Section
9.6, and except as provided in Section 2.10 or in connection with any Small
Business Innovative Research Grant(s) received by RiboGene from the National
Institutes of Health prior to or during the Research Term, neither RiboGene nor
any of its Affiliates, without receiving the written approval of Xxxxxx, shall
conduct or have conducted independent
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research in the Field, or accept funding for research in the Field from or
provide research services in the Field to or consult in the Field for any third
party or permit any third party to use or benefit from any RiboGene Intellectual
Property in the Field, or invest or become a partner or shareholder in or
provide funding or technology or personnel to any entity for purposes of
conducting research in or developing or commercializing products for the Field,
or establish a joint venture in the Field with any entity.
2.10 Exception to Exclusively The provisions of Section 2.9
notwithstanding, RiboGene may screen synthetic chemical compounds and/or
biological Materials owned and provided by an agrochemical company, with which
RiboGene is negotiating as of the Effective Date and the identity of which
RiboGene will disclose to Xxxxxx as RiboGene Confidential Information on the
Effective Date, in either or both of the two translation-based antifungal assays
within RiboGene Intellectual Property that are in existence on the Effective
Date, with the understanding that:
(a) RiboGene and/or Xxxxxx shall compare the library of compounds
and/or materials provided by the agrochemical company with those in Xxxxxx'x or
Xxxxxx Affiliate's libraries and those identified as RiboGene Compounds, and
RiboGene shall, without identifying the reason to the agrochemical company,
refuse to screen any compounds and/or materials identified as Xxxxxx Compounds
or RiboGene Compounds, according to the definitions above, for the agrochemical
company;
(b) RiboGene shall use its best efforts to obtain the right,
under the rights of the agrochemical company, for Xxxxxx, Xxxxxx Affiliates
and/or Xxxxxx sublicensees, for the same milestone and royalty obligations as in
the License Agreement and no other consideration, to modify, make, have made,
develop, use, register, promote, offer for sale and sell such agrochemical
company's compounds and/or materials for human or animal therapeutic and/or
diagnostic purposes; and
(c) RiboGene shall not grant rights to the agrochemical company to
use RiboGene technology or any results of the use of RiboGene technology to
identify, make, have made, import, use, evaluate, develop, promote, offer to
sell and/or sell any compound or material for the treatment, mitigation, cure,
prevention, detection and/or monitoring of fungal infections or diseases in
humans or animals.
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III. OVERSIGHT OF THE RESEARCH PROGRAM
3.1 JMT Duties The duties of the Joint Management Team shall be to:
(a) Review, modify, and/or approve, in writing, each Annual
Research Plan;
(b) Receive and review communications and/or reasonably detailed
reports, according to the provisions of Section 2.6, from each party on its
activities under each Annual Research Plan, and otherwise monitor the progress
of the Research Program, modifying such Annual Research Plan(s) and/or making
recommendations to both parties for the modification of the Research Program in
order to better fulfill the objectives of the parties;
(c) Approve, in writing, the significant use of every third party
entity which RiboGene would like to use in the performance of its material
obligations under the Research Program; and
(d) Review all preclinical data, generated by RiboGene and/or
Xxxxxx hereunder, on all Xxxxxx Compounds and RiboGene Compounds, identify and
select RiboGene Leads and promising Xxxxxx Compounds as foci for further work
under the Research Program, and, when appropriate, recommend to Xxxxxx that it
should consider and/or adopt a plan to develop one or more particular Xxxxxx
Compounds and/or RiboGene Leads which demonstrate an attractive antifungal
activity and safety profile, according to the standards which the JMT shall
adopt.
3.2 JMT Composition The Joint Management Team shall be comprised of
three (3) official representatives appointed by each party, initially
comprising:
From Xxxxxx From RiboGene
Xxxxx X. Xxxxxxxx, Ph.D. Xxxxx X.X. Xxxxx, Ph.D.
Xxxx X. Xxxxxx, Ph.D. Xxxxxxx X. Mochle, Ph.D.
Xxxxxx X. Xxxxxxx, Ph.X. Xxxxx X. Xxxxx, Ph.D.
and shall be chaired by [*] from Xxxxxx. Each party may appoint one or more
alternates for such party's representatives upon reasonable notice to the other
party, with an alternate being counted for purposes of constituting a quorum
and/or being able to vote on a JMT
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matter, according to the provisions of Section 3.5 in both cases, only if the
representative for whom the alternate is substituting is not present. Either
party may change any of its official representatives or alternates, if
applicable, to the JMT, and Xxxxxx may replace the chair of the JMT, upon
reasonable notice to the other party.
3.3 RiboGene Representatives Should two (2) or more of the official
RiboGene representatives initially appointed to the JMT relinquish active
participation in the Research Program, RiboGene shall notify Xxxxxx, in advance
if possible, and RiboGene and Xxxxxx shall promptly confer to evaluate the
potential impact of such losses on the Research Program. They shall, as
necessary, develop alternatives acceptable to both parties to assure
continuation of effective research oversight and direction. In the event the
parties are unable to agree upon an acceptable alternative after good faith
discussions, Xxxxxx shall have the right, but not the obligation, to immediately
terminate this Research Agreement without further liability if Xxxxxx reasonably
determines that RiboGene will not be replacing a departed/departing
representative with an individual of comparable or superior skills, experience
and qualifications, except for the reimbursement of RiboGene's documented,
reasonable, irrevocable commitments, which cannot otherwise be mitigated, as
provided and limited in Section 9.3.
3.4 Meetings The Chair shall convene the JMT in person at least once in
each Contract Quarter, with the meeting location alternating between Xxxxxx
Park, Illinois and Hayward, California, or at sites otherwise agreed upon by the
parties. A representative of the party which is acting as host of the meeting
(i.e., the party located closest to the meeting site or, if the meeting is not
near the headquarters of either, the party which had not hosted the most recent
previous meeting) shall keep detailed records of such meeting and decisions,
and shall distribute copies of such records, together with a copy of all
written reports presented at the meeting, to all designated representatives and
alternates, if applicable, of the JMT. The Chair of the JMT shall be
responsible for keeping an official copy of all JMT meeting minutes and all
reports to the JMT. When a physical meeting is impractical, but JMT business
must be conducted between physical meetings, the Chair may convene a
teleconference of representative(s) and/or alternate(s), if applicable, of
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the parties, and the Chair shall designate a representative of one of the
parties to record and distribute a detailed record of such teleconference. In
all cases, each party shall pay all costs incurred by its own participation in
and, as applicable, its hosting of JMT meetings.
3.5 Decision Making The attendance or presence of at least two (2)
official representative(s) and/or previously-designated alternate(s), if
applicable, of each party shall constitute a quorum for purposes of the JMT
taking any action. All decisions of the JMT shall be reached by majority vote of
all of the official representatives/alternates present in person or by proxy,
with each official representative having one (1) vote on the JMT, and, if
necessary to break a tie in any vote, the Chair having one (1) extra vote.
3.6 Annual Research Plan Not later than sixty (60) days prior to the end
of each Contract Year following which research under this Agreement is to
continue, RiboGene and Xxxxxx will jointly provide an Annual Research Plan for
the following Contract Year (including, if relevant, any twelve (12)-month
extension of the initial three (3)-year Research Term), to the JMT, which shall
review and attempt to approve the Annual Research Plan for the following
Contract Year by not later than thirty (30) days prior to the end of the
then-current Contract Year. Notwithstanding anything in this Agreement to the
contrary, the JMT may at any time during the term of this Agreement amend the
current Annual Research Plan.
IV. RESEARCH SUPPORT
4.1 Xxxxxx Funding As consideration for RiboGene exerting all reasonable
efforts in the conduct of the Research Program and for the rights granted
hereunder, Xxxxxx shall provide to RiboGene Five million United States dollars
(USD5,000,000) in funding, including payments for salaries, supplies,
materials, technology and other costs attributable to the Program, calculated on
a fully-burdened basis in accordance with standard accounting practices, for the
first three (3) years of the Research Program. In fulfillment of its obligations
hereunder, Xxxxxx shall pay to RiboGene: Four hundred seventeen thousand U.S.
Dollars (USD417,000) within fifteen (15) calendar days after the Effective Date
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and within fifteen (15) calendar days of each of the following ten (10)
successive three (3)-month anniversaries thereof, and four hundred thirteen
thousand U.S. dollars (USD413,000) for total payments of five million United
States dollars (USD5,000,000) during the initial three (3)-year Research Term.
RiboGene shall have no obligation to incur expenses in the conduct of the
Research Program in excess of the amounts funded under this Section 4.1, unless
RiboGene shall receive sufficient additional funding from Xxxxxx to cover such
additional expenses, payable by Xxxxxx based on invoices for expenses, which
expenses have been preapproved in writing by the JMT before such additional
expenses are incurred, with such invoices, or other documentation acceptable to
the JMT, being submitted to Xxxxxx within thirty (30) days of the end of the
Contract Quarter during which such additional expenses were incurred. In the
event of premature termination of the Research Program or any other event
resulting in an incorrect payment by Xxxxxx, RiboGene shall remit any
overpayment amount in such incorrect payment to Xxxxxx, subject to the
provisions of Section 9.3, within thirty (30) days after such overpayment occurs
or is identified by either of the parties and, if necessary, brought to
RiboGene's attention.
4.2 Control RiboGene shall closely monitor expenditures for the
Research Program and shall take all necessary steps to cause the funds provided
by Xxxxxx to be spent in accordance with this Agreement to accomplish the
objectives of the Research Program. It shall provide to the JMT, within thirty
(30) calendar days of the end of each Contract Quarter and within forty-five
(45) days of the end of the Research Term, as the case may be, either a detailed
written report of costs incurred by it in its Research Program activities during
the preceding Contract Quarter or a summary report of the costs incurred by it
during the entire Research Program.
V. CONFIDENTIALTY OF INDEPENDENT AND PROGRAM INFORMATION
5.1 Confidentiality and Nonuse Xxxxxx and RiboGene agree that, for a
period of ten (10) years from the Effective Date, each will treat as
confidential, limiting access to the Receiving Party employees and
confidentiality-bound consultants who must know information for purposes
anticipated by this Agreement, and otherwise using at least the
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21
same internal security procedures and at least the same degree of care that it
uses to protect its own confidential, proprietary information, but in no event
less than reasonable care, to prevent the other party's Independent Information
that it receives and accepts under this Agreement, and Program Information,
according to the provisions of Section 5.4, generated under the provisions of
this Agreement, from entering the public domain or falling into the hands of
independent third parties, or from being used for its own benefit or the benefit
of any third party, except for purposes of this Agreement. No right to use, or
any title or license to the other party's Independent Information or Program
Information, other than the right to use such Independent Information and
Program Information for purposes of this Agreement, shall vest in the Receiving
Party or the Collateral Party, as the case may be, by virtue of disclosure, or
the existence of this Agreement, or the conduct of the Research Program. Should
either party use one or more independent consultants or collaborators for
purposes of this Agreement, that party shall execute appropriate confidentiality
agreements with any such third party consultant(s) or collaborator(s) in order
to protect the secrecy of the other party's proprietary information.
5.2 Required Disclosure If either party is required by a governmental
regulatory agency or court of competent jurisdiction to disclose either the
other party's Independent Information or Program Information, deemed
confidential to the other party under the provisions of Section 5.4, or to
disclose other details of this Agreement or of the Research Program, the party
subject to such requirement shall: (a) inform the other party as soon as
practical of such requirement; (b) reasonably cooperate with the other party in
efforts such other party may decide to take to try to protect its Independent
Information and/or Program information; and (c) release such Independent
Information and/or Program Information or other Program or Agreement details in
response to such requirement to the extent, and only to the extent, required by
such authority.
5.3 Return of Independent and Program Information Upon expiration of
this Agreement, and the request of the original Disclosing Party or Beneficiary
Party, as the case may be, or upon early termination hereof, the Receiving Party
or Collateral Party, as the case may be, shall,
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within one (1) month of such request or early Agreement termination, return or
deliver all copies of the Disclosing Party's Independent Information, as well as
Program Information deemed confidential to such party under the provisions of
Section 5.4, which Independent Information and Program Information is then in
the Receiving Party's/Collateral Party's possession, to the Disclosing
Party/Beneficiary Party, but the Receiving Party/Collateral Party, as the case
may be, may retain one (1) complete documentation copy of that Independent
and/or Program Information for archival purposes, only to assure compliance with
this Agreement, but shall not thereafter use or disclose any of the Disclosing
Party's Independent Information and/or the Beneficiary Party's Program
Information or claim any rights thereto.
5.4 Program Information All Program Information generated under this
Agreement shall be considered confidential by the party generating and the party
receiving such information from generation thereof through at least ninety (90)
days after the Receiving Party has received a reasonably-detailed description of
such Program information. RiboGene shall deem Program Information which relates
to Xxxxxx Compounds and/or RiboGene Leads, and the characteristics, processes
for making and use thereof, and is identified and summarized in reasonable
detail in a writing, marked "Confidential", that is provided to RiboGene by
Xxxxxx within the above-described ninety (90)-day period, to be Xxxxxx'x
property (Xxxxxx being the "Beneficiary Party" and RiboGene being the
"Collateral Party", in this case) and to treat it in the same way it would treat
Xxxxxx'x Independent Information under the provisions of Section 5.1. Xxxxxx
shall likewise deem Program Information which relates to the RiboGene's
proprietary screening and lead-identification technologies (i.e., Know-how)
existing on the Effective Date, and is identified and summarized in reasonable
detail in a writing, marked "Confidential", that is provided to Xxxxxx by
RiboGene within the above-described ninety (90) day period, to be RiboGene's
property (RiboGene being the "Beneficiary Party" and Xxxxxx being the
"Collateral Party", in this case) and to treat it in the same way it would treat
RiboGene's Independent Information under the provisions of Section 5.1. Program
Information which relates to one or more Program Inventions or Joint Program
Inventions, according to the provisions of Section 6.4, shall be kept
confidential by both parties at least until Xxxxxx can determine the commercial
relevance or value of
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such Program Information or Joint Program Invention, which Xxxxxx will make all
reasonable efforts to do in a reasonable amount of time. RiboGene may request
Xxxxxx, at any time, to release any portion of Program Information from the
foregoing confidentiality restrictions and Xxxxxx will not unreasonably refuse
such request. Unless such Program Information is released by Xxxxxx or
otherwise published in a patent application, such Program Information shall be
considered confidential by both parties at least during the Research Term.
5.5 Nondisclosure of Third Party Confidential Information Neither
party shall disclose to the other any information which is confidential and/or
proprietary to any independent third party.
5.6 Publicity Except as permitted under Section 5.7, neither party
shall make any press release, or create any advertising, sales or other
promotional literature referring to this Agreement or the relationship
hereunder, or, except as required by applicable laws or regulations, make any
other public written or oral disclosure or statements relating to the Research
Program or the relationship between the parties created by this Agreement,
including stating, implying or suggesting that any form of joint venture,
affiliation or other association exists as a result of this Agreement between
RiboGene and Xxxxxx, without the prior written approval of the other party,
which approval shall not be unreasonably withheld.
5.7 Permitted Disclosure Xxxxxx may disclose such information related
to the Research Program as is essential to enable Xxxxxx to carry out the
evaluation and/or development of any product, process or service discovered or
developed employing results of the Research Program or to secure a governmental
approval therefor.
5.8 Publications Each party shall submit to the other, at least
forty-five (45) days prior to submission for publication or from otherwise
sharing with independent third parties, either the draft of any manuscript
comprising details of or results from the Research Program that such furnishing
party intends to submit for publication, or the subject matter comprising such
details or results that it would otherwise like to share with independent third
parties. Within such forty-five (45)-day period,
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the receiving party will advise the furnishing party, in good faith, of any
potential material adverse consequences of such disclosure perceived by the
receiving party. The furnishing party may then either (i) delete the sensitive
Independent Information and/or Program Information from the manuscript and
substitute scientifically-meaningful information that does not contain the
receiving party's Independent Information or its Program Information still
subject to confidential treatment by the furnishing party according to the
provisions of Section 5.4, or (ii) suspend plans for such publication or other
disclosure. Upon Xxxxxx'x request, or Xxxxxx'x approval of RiboGene's request,
RiboGene shall acknowledge Xxxxxx'x support of the Research Program in approved
scientific publications or other approved communications.
VI. RIGHTS TO PROGRAM INVENTIONS
6.1 Disclosure of Inventions Program Inventions shall be promptly
disclosed by the originating party to the other party, and Joint Program
Inventions shall be promptly fully shared between the parties.
6.2 Determination of Inventorship Upon the sharing of reasonably-full
details of such Program Inventions and Joint Program Inventions, the respective
patent authorities of the parties shall determine inventorship of such Program
Inventions and Joint Program Inventions, in good faith, according to United
States patent practice. In the event such patent authorities of the parties
cannot agree on the determination of inventorship of a Program Invention or
Joint Program Invention, the parties shall jointly refer the question of such
inventorship to independent outside patent counsel jointly selected and paid in
equal measure by the parties, and the parties shall be bound by the
determination of inventorship of the Program invention or Joint Program
Invention made by such independent patent counsel.
6.3 First Assignment of Rights The respective patent authorities of the
parties shall make an initial determination of the subject matter of the
Program Invention or Joint Program Invention, using all reasonable efforts to
resolve any disagreement between them, and based on that/those determination(s),
Program Inventions or Joint Program Inventions which directly relate to Xxxxxx
Compounds and/or RiboGene
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Leads and the processes of making and use thereof shall be assigned to Xxxxxx,
with all rights to make, have made, import, use, offer to sell, sell and/or
sublicense such Program Inventions or Joint Program Inventions, regardless of
the inventorship of such Inventions, and Program Inventions or Joint Program
Inventions which directly relate to RiboGene's proprietary screening and
lead-identification technologies in existence as of the Effective Date shall be
assigned to RiboGene, with all rights to make, have made, import, use, offer to
sell, sell and/or sublicense such Program Inventions or Joint Program
Inventions, regardless of the inventorship of such Inventions. Xxxxxx shall be
responsible for all decisions, with reasonable consideration of the
confidentiality interests of RiboGene, as well as for all costs related to all
preparation and filings (domestic and international), and related patent
prosecution, issuance, maintenance, enforcement and defense, according to
Xxxxxx'x patent policies and procedures, directly related to Xxxxxx Compounds
and/or RiboGene Leads and the processes of making and use thereof. RiboGene
shall be responsible for all decisions, with reasonable consideration of the
confidentiality interests of Xxxxxx, as well as for all costs, related to all
preparation and filings (domestic and international), and related patent
prosecution, issuance, maintenance, enforcement and defense, according to
RiboGene's patent policies and procedures, directly related to RiboGene's
proprietary screening and lead-identification technologies in existence as of
the Effective Date. Each Collateral Party, under this Section 6.3, shall
cooperate with the Beneficiary Party's designated patent counsel to provide
reasonable assistance, at the Beneficiary Party's expense, in any activities the
Beneficiary Party chooses to pursue to protect its interests In such Program
Inventions and/or Joint Program Inventions, without any obligation to or
remaining right In that Collateral Party under any resulting patent(s). However,
neither party shall have any obligation to the other party to file, prosecute,
issue, maintain, enforce or defend any patent application or patent claiming a
Program Invention or Joint Program Invention related to its interests as
delineated immediately above.
6.4 Alternate Assignment of Rights (a) As to any Program Inventions
which do not fit Into either the category directly assignable to Xxxxxx or the
category directly assignable to RiboGene according to the provisions of Section
6.3, which are made solely by Inventors who are
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employees or associates, at the time of inventive contribution, of either
RiboGene or Xxxxxx, the party of which the inventors are employees or
associates, shall have the right to elect to retain title to those Program
Inventions.
If the party, the employee(s) of which is/are sole inventor(s) of such Program
Invention, is Xxxxxx, Xxxxxx shall be responsible for all decisions and costs
related to whether to file for patent protection, as well as to the preparation,
domestic and/or foreign filing(s), related patent prosecution, issuance,
maintenance, enforcement and defense of patent applications and/or patents
covering such Program Invention, according to its patent policies and
procedures.
If that party is RiboGene, RiboGene shall offer the Program Invention to Xxxxxx,
and if, within forty-five (45) days of receiving a reasonably-detailed written
description of the Program Invention, Xxxxxx notifies RiboGene that Xxxxxx is
interested in having a nonexclusive license, with the right to sublicense only
for Xxxxxx'x direct research and/or production benefit, under any resulting
patent rights in such Program Invention, Xxxxxx shall, in good faith, assume the
responsibility, employing standards and criteria no less rigorous than it
employs with respect to the protection of its own inventions of similar
scientific and commercial value, keeping RiboGene fully aware of the filing and
status of any patent application(s) and/or patent(s) covering such Program
Invention and involved with pertinent decisions with respect to such patent
application(s) and/or patent(s) and fully considering RiboGene's interests and
suggestions with respect to the scope and content of such application(s) and/or
patent(s), for preparing, in cooperation with RiboGene's designated patent
counsel, filing (domestic and foreign--with RiboGene as assignee of such
application(s)), prosecuting, issuing, maintaining, defending and enforcing such
patents and/or patent applications, including assuming all costs, and receiving
for its own benefit all recoveries, associated with all patent applications
and/or patents in which it has an interest. Failure by Xxxxxx to notify
RiboGene, within such forty-five (45) day period, of Xxxxxx'x interest in having
a nonexclusive license to such Program invention shall be deemed to be a waiver
of Xxxxxx'x interest in such a license.
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In cases of a RiboGene Program Invention in which Xxxxxx notifies RiboGene that
Xxxxxx has no interest, or after forty-five (45) days following Xxxxxx'x receipt
of a reasonably-detailed description of such Program Invention when Xxxxxx has
not indicated an interest to RiboGene, or in specific cases of actual or
possible patent application(s) and/or patent(s) claiming such RiboGene Program
Invention in jurisdictions in which Xxxxxx has no or no longer has an interest,
Xxxxxx, according to the particular circumstances, shall relinquish all rights
to and interest in such Program Invention to RiboGene and/or shall offer to
assign such patent application(s) and/or patent(s) claiming such RiboGene
Program Invention to RiboGene, or if RiboGene has no interest, may abandon such
patent application(s) and/or patent(s), at Xxxxxx'x option and according to
Xxxxxx'x policies. Upon either relinquishing its interest or assigning such
patent application(s) and/or patent(s) to RiboGene, Xxxxxx shall cooperate with
and provide reasonable assistance to RiboGene, at RiboGene's expense, for any
activities RiboGene chooses to pursue with respect to such patent application(s)
and/or patent(s) claiming such Program Invention, including filing patent
application(s), or assuming all rights to the filing(s) or other actions that
Xxxxxx has already taken with respect to that Program Invention, and/or taking
such other action(s) as it desires, in its sole discretion and at its sole
expense from then on, with respect to such Program Invention, and Xxxxxx will
consequently have no rights or obligations relative to patent rights covering
that particular Program Invention either anywhere or in particular
jurisdictions, as the case may be.
(b) As to any Joint Program Inventions which do not fit into either the
category directly assignable to Xxxxxx or the category directly assignable to
RiboGene according to the provisions of Section 6.3, wherein employees or
associates of each of the parties have been identified as inventors of the same
invention conceived and reduced to practice under the Program, according to
United States patent practice, each party may elect to retain its undivided
interest in such Joint Program Invention and will consult with the other party
on whether and where to file patent applications on such Joint Program
Invention.
If, within forty-five (45) days of the mutual written agreement that there is a
Joint Program Invention on which one or more patent applications
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should be filed, Xxxxxx notifies RiboGene that it is interested in retaining its
undivided interest under any resulting patent rights in such Joint Program
Invention, Xxxxxx shall, in good faith, assume the responsibility, employing
standards and criteria no less rigorous than it employs with respect to the
protection of its own inventions of similar scientific and commercial value,
keeping RiboGene fully aware of the filing and status of any patent application
and/or patent covering such Program Invention and involved with pertinent
decisions with respect to such patent application and/or patent and fully
considering RiboGene's interests and suggestions with respect to the scope and
content of such application and/or patent, for preparing, in cooperation with
RiboGene's designated patent counsel, filing (domestic and foreign--with both
Xxxxxx and RiboGene being named assignees of such application(s)), prosecuting,
issuing, maintaining, defending and enforcing such patent applications and/or
patents, including assuming all costs associated with all patent applications
and/or patents in which it continues to have an interest.
As in Section 6.4(a), in cases of actual or possible patent applications and/or
patents claiming a particular Joint Program Invention in jurisdictions in which
Xxxxxx has no or no longer has an interest, or if Xxxxxx has no interest in
retaining its rights In such Joint Program Invention, Xxxxxx, according to the
particular circumstances, shall relinquish all rights to, interest in or
obligations under any patent application or patent covering such Joint Program
Invention to RiboGene, and/or shall offer to assign such patent applications
and/or patents to RiboGene, or if RiboGene has no interest, the, parties will
jointly abandon such patent application(s) and/or patent(s), according to
Xxxxxx'x policies. Upon either relinquishing its interest or assigning such
patent application(s) and/or patent(s) to RiboGene, Xxxxxx shall cooperate with
and provide reasonable assistance to RiboGene, at RiboGene's expense, for any
activities RiboGene chooses to pursue with respect to such patent applications
and/or patents, including filing patent application(s), or assuming all rights
to the filing(s) or other actions that Xxxxxx has already taken with respect to
that Joint Program Invention, and/or take such other action(s) at it/they
desire(s), in, its/their sole discretion and at its/their sole expense from then
on, with respect to such Joint Program Invention, and Xxxxxx will consequently
have no rights or obligations relative to patent rights covering that particular
Joint Program Invention
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either anywhere or in particular jurisdictions, as the case may be.
6.5 Ownership Rights RiboGene acknowledges that Xxxxxx shall have full
ownership, title, interest and all rights in and to all Xxxxxx Compounds and,
subject to the provision of the second sentence of Section 1.20, each RiboGene
Lead provided under this Agreement, to the extent that RiboGene is able to grant
such exclusive ownership to same, and that Xxxxxx, at its own expense, may use
such Xxxxxx Compounds and/or RiboGene Leads in any manner that Xxxxxx, at its
sole option, shall choose, not limited to development of such Xxxxxx Compound
and/or RiboGene Lead for an indication identified with the Research Program.
RiboGene shall not disclose any information which is specific to such Xxxxxx
Compounds and/or RiboGene Leads, not including information related to RiboGene
Intellectual Property which does not involve Xxxxxx Compounds and/or such
RiboGene Leads, except pursuant to the Research Program. Any Information,
inventions or discoveries (whether patentable or not), innovations, ideas,
communications, correspondence, notes, laboratory notebooks, reports, data,
records, results, and all derived products, which are conceived, reduced to
practice, made or developed by or for Xxxxxx with such Xxxxxx Compounds,
RiboGene Leads and/or Product(s) based thereon, as well as all files,
registrations or marketing approvals related to such Xxxxxx Compounds, RiboGene
Leads and/or Product(s), shall be the sole property of Xxxxxx. Xxxxxx
acknowledges that, under this Agreement, Xxxxxx shall have no right to restrict
RiboGene's activities with any compound or material other than Xxxxxx Compounds
and RiboGene Leads.
6.6 Invention Use During the Research Term Notwithstanding any of the
ownership and/or rights provisions of Sections 6.3, 6.4 and 6.5, RiboGene shall
have a nonexclusive, nontransferrable, royalty-free license to practice any
Program Invention assigned to Xxxxxx and/or Joint Program Invention for purposes
of the Research Program during the Research Term.
6.7 Invention Rights Following the Research Term Following the
termination or expiration of the Research Term, each party may practice any
Program Invention and/or Joint Program Invention for which that party is the
sole or joint title holder and/or patentee, and for which it has not forfeited
its rights, according to the provisions of Section 6.4,
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without obligation to the other party. Also following such termination or
expiration, RiboGene shall also be free to nonexclusively license its rights to
Program Invention(s) under Section 6.4(a) or Joint Program Invention(s) under
Section 6.4(b) that are solely or jointly assigned to RiboGene, and may
exclusively license such rights to such Program Invention(s) and Joint Program
Invention(s) in which Xxxxxx has failed to exercise or has disclaimed an
interest, without obligation to Xxxxxx.
VII. WARRANTIES AND LIMITATIONS ON RIGHTS
7.1 RiboGene Warranties RiboGene hereby represents and warrants to
Xxxxxx that, as of the Effective Date: (a) RiboGene has or will have upon
execution of this Research Agreement and the fulfillment of Xxxxxx'x financial
obligations hereunder, all the requisite resources, power and authority to
execute, deliver and perform this Agreement based on RiboGene's assumptions
regarding its funding requirements; (b) RiboGene will commit the resources and
skilled personnel necessary to fulfill its obligations under the Research
Program and will spend the research funds provided by Xxxxxx hereunder solely in
support of the Program and for RiboGene's fully-burdened expenses related
specifically thereto; (c) the terms of this Agreement are not inconsistent with
any other contractual and/or legal obligations it may have, or with its policies
or the policies of any entity with which it is associated; (d) RiboGene believes
to the best of its knowledge, that it owns or otherwise has all necessary rights
to the screening and lead-identification technology and other RiboGene
Intellectual Property in existence as of the Effective Date that it proposes to
apply in the Research Program, and will own or otherwise have all necessary
rights to the anticipated screening and lead-identification technology and other
RiboGene Intellectual Property that it is developing and proposes to apply in
the Research Program; (e) it has experience with respect to the safety and
handling of the types of biological materials and synthetic chemicals that it
may be screening for Xxxxxx hereunder; (f) it will provide all safety and
handling information related to materials, including RiboGene Compounds, or
other results coming from the Research Program and all know-how related thereto
of which it is aware, upon delivery of such materials or results to Xxxxxx; (g)
it has not and shall not engage in any act inconsistent With this Agreement,
particularly that would allow any third party, including
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any government or government agency, to acquire, own or possess any right or
interest inconsistent with Xxxxxx'x rights in any invention (whether patentable
or not), trade secret, or other proprietary right that arises out of or is made
as a consequence of this Agreement; and (h) this Agreement has been duly
authorized and, when executed and delivered by RiboGene, shall constitute a
legal, binding obligation, enforceable against RiboGene, according to its terms.
7.2 Limitation on Warranties RiboGene makes no representation or
warranty that the RiboGene Compounds identified to Xxxxxx by. RiboGene hereunder
are novel entities or will not infringe the patent rights of others, but only
that the RiboGene Compounds which may be provided to Xxxxxx hereunder will be
representative samples of such entities.
7.3 Disclaimer Xxxxxx and RiboGene each understands that neither party
can guarantee the reliability of its research findings and conclusions, and
therefore, except as expressly set forth in this Agreement, NEITHER PARTY HAS
MADE OR MAKES ANY GUARANTEES AND EXTENDS ANY WARRANTIES OF ANY KIND, EITHER
EXPRESS OR IMPLIED, EXCEPT AS EXPRESSLY PROVIDED HEREIN. THERE ARE NO EXPRESS OR
IMPLIED WARRANTIES OF DESIGN, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, OR THAT ANY RIBOGENE OR XXXXXX COMPOUNDS IDENTIFIED IN THE RESEARCH
PROGRAM WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER INTELLECTUAL
PROPERTY RIGHTS OF ANY INDEPENDENT THIRD PARTY. FURTHER, THERE ARE NO OTHER
EXPRESS OR IMPLIED WARRANTIES ARISING FROM THE COURSE OF DEALING, USAGE OR TRADE
PRACTICES, OR OF ANY OTHER KIND.
7.4 Limitations on Rights Nothing In this Agreement shall be construed
as:
(a) conferring rights to use in advertising, publicity,
promotional or sales literature the name of the other party. or anything
relating to the Research Program, without the prior written consent of the other
party In each instance; or
(b) granting, by implication, estoppel, or otherwise as a result of
this Agreement, any activities hereunder or the relationship of the parties, any
license, title, ownership or other rights to the other party's Independent
Information or Program Information or under patents
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or know-how of the other party except as necessary to accomplish the purposes of
the Research Program and this Agreement or except as explicitly provided herein.
Each party acknowledges that, by virtue of this Agreement it acquires only such
rights as set forth under the terms and conditions of this Agreement.
VIII. LIABILITIES AND INDEMNITY
8.1 Liabilities Each party shall assume the responsibility for and
will pay all costs and expenses (including reasonable attorneys' fees and
expenses of litigation) related to liability, losses or damage to property,
including environmental, and injury or death to any persons, including employees
of either, incurred in connection with any claims, suits, actions, demands or
judgments arising out of (a) any failure by such party to strictly adhere to
safety instructions, precautions and information provided by the other party
and/or other generally-recognized safety practices for the storage, handling,
use and/or disposal of any biological, chemical or other materials employed
under or resulting from this Agreement; (b) any use by such party of information
or materials developed under the Research Program or the use, handling, storage
or disposal of any Xxxxxx Compound(s) or RiboGene Compound(s) resulting from the
Research Program, except in reliance on a willful or grossly negligent
misrepresentation or wrongdoing of the other party; or (c) any noncompliance or
breach of this Agreement or other willful or negligent act or omission on its
part in the performance of activities and/or obligations under this Agreement.
Each party shall, however, provide the party assuming responsibility with
assistance and/or information, at the responsible party's reasonable expense,
with respect to any charge, claim, investigation or proceeding. EXCEPT AS SET
FORTH IN SECTION 8.2, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER
PARTY FOR LOST PROFITS OR ANY CONSEQUENTIAL, SPECIAL INCIDENTAL, OR INDIRECT
DAMAGES OF SUCH OTHER PARTY, HOWEVER CAUSED AND/OR ON ANY THEORY OF LIABILITY,
ARISING OUT OF THIS AGREEMENT.
8.2 Indemnification Each party (the "Indemnifying Party") shall defend
the other party and such other party's agents, Affiliates, employees, officers,
directors, shareholders and permitted successors and
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assigns (collectively, the "Indemnified Parties") against any claim made against
any or all of the Indemnified Parties by any third party, to the extent that
such claim arises out of any negligent, reckless or intentionally wrongful act
or omission of the Indemnifying Party or breach of this Agreement by the
Indemnifying Party. The Indemnifying Party shall either settle such claim or pay
all damages awarded against any or all of the Indemnified Parties by a court of
competent jurisdiction as a result of such claims, but no indemnification shall
necessarily be provided for such claim if the particular Indemnified Party(ies)
does/do not notify the Indemnifying Party promptly in writing of the claim, give
the Indemnifying Party the exclusive control of the defense and settlement
thereof, and provide all reasonable assistance In connection with the defense
or settlement thereof, at the Indemnifying Party's expense.
IX TERM AND TERMINATION
9.1 Term This Agreement shall be effective upon the Effective Date and
shall continue in effect through the expiration or termination of the Research
Term, unless extended in writing in accordance with the provisions of Section
9.2.
9.2 Possible Extension Upon the mutual agreement of the parties, this
Research Agreement may be extended for a period and under such other provisions
and/or amendments to the provisions of this Agreement, to be agreed upon in good
faith negotiations between the parties.
9.3 Termination Without Breach Prior to the expiration of the Research
Term, Xxxxxx may terminate this Agreement in its entirety without cause upon
sixty (60)-days written notice to RiboGene. Upon such termination, Xxxxxx shall
reimburse RiboGene for all documented, reasonable irrevocable commitments made
by RiboGene on behalf of the Research Program that are not covered by payments
made by Xxxxxx to RiboGene prior to such termination, but in no event shall
Xxxxxx be obliged to make payments to RiboGene which shall result in total
aggregate payments, according to the provisions of Article IV, of more than Five
million U.S. dollars (USD5,000,000) without the prior written approval of
Xxxxxx. RiboGene shall, however, use all reasonable efforts to mitigate these
costs by, inter alia, reassigning personnel and transferring supplies,
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materials and/or technology, where practical. In the event of any overpayment by
Xxxxxx, RiboGene shall remit the same to Xxxxxx within thirty (30) days of the
termination of the Research Program.
9.4 Effect of Breach In the event of a breach by RiboGene of any
material provision of this Agreement, or default by Xxxxxx of any of Xxxxxx'x
financial obligations to RiboGene or a material breach by Xxxxxx of Xxxxxx'x
confidentiality obligations hereunder, the aggrieved party shall give the party
in breach or default thirty (30)-day written notice to cure or substantially
cure such breach or default. If the breach or default is not cured or not
substantially cured within such thirty (30)-day period, the aggrieved party
shall immediately submit any dispute raised in a response to the aggrieved
party's written notice to the Alternative Dispute Resolution provisions of
Section 10.7, and only if the other party fails to honor the resolution of the
Alternative Dispute Resolution procedures may the aggrieved party terminate this
Agreement upon giving final written notice to the other party.
9.5 Effect of Bankruptcy or Agreement Revision Xxxxxx may terminate
this Agreement upon the filing of a voluntary petition in bankruptcy by RiboGene
or a third party's filing of an involuntary petition in bankruptcy with respect
to RiboGene, which involuntary petition is not dismissed within forty-five (45)
days after the filing thereof, or if removal of a material part or parts of this
Agreement which are found to be void, invalid or unenforceable according to the
provisions of Section 10.9 would so substantially impair the value of the whole
Agreement to Xxxxxx as to make continuance Impractical. If at any time during
the anticipated term or any extended term of this Agreement RiboGene files for
bankruptcy or an involuntary petition with respect to RiboGene is not dismissed,
and providing Xxxxxx shall have paid to RiboGene or trustee(s) therefor at least
one million U.S. dollars (USD1,000,000) anticipated under the provisions of
Section 4.1 and all reasonable additional amounts, If any, that are owed to
RiboGene for activities actually fulfilled under the provisions of an extension
to this Agreement, provided for in Section 9.2, Xxxxxx shall receive sufficient
representative amounts of all RiboGene Compound(s), whether originally
independently owned by or licensed to RiboGene or subsequently owned, purchased
or licensed by RiboGene during the Research Term, to complete or have completed
the
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the Commission. Confidential treatment has been requested with respect to
the omitted portions.
35
anticipated Provisions and/or possibilities of this Agreement and shall
thereafter have a fully paid-up, nonterminable, nonexclusive license from
RiboGene and/or its trustee(s) to screen and/or otherwise use RiboGene Compounds
and RiboGene Intellectual Property to complete the anticipated provisions and/or
possibilities of the Research Program. At Abbot's option, Xxxxxx shall have the
right under RiboGene Intellectual Property to make, have made, import, develop,
use, and otherwise evaluate Xxxxxx Compounds and/or RiboGene Compounds, and,
with RiboGene's trustee(s) acting in RiboGene's stead, the right to obtain an
exclusive license to make, have made, import, use, offer for sale and sell
RiboGene Compounds and/or Products for consideration (i) equal to 100% of that
anticipated in the License Agreement, in the event that RiboGene files for
bankruptcy, or an involuntary petition with respect to RiboGene is not dismissed
within forty-five (45) days after the filing thereof, after the conclusion of
the Research Term, or (ii) that shall be negotiated in good faith between Xxxxxx
and the trustee(s), but will be no more than fifty percent (50%) of that
anticipated in the License Agreement, in the event that RiboGene files for
bankruptcy, or an involuntary petition with respect to RiboGene is not dismissed
within forty-five (45) days after the filing thereof, prior to the conclusion of
the Research Term.
9.6 Consequences of Termination Expiration or termination of this
Agreement by either party shall not affect the rights and obligations of the
parties that have accrued prior to the effective date of termination of this
Agreement, including provisions referenced In the License Agreement which
survive this Agreement, to the extent such survival is necessary for the
interpretation of a provision of the License Agreement. Should Xxxxxx terminate
this Agreement under the provisions of Section 9.3, or should Xxxxxx fail to
honor the resolution of the Alternative Dispute Resolution provisions of Section
10.7 initiated by RiboGene under the provisions of Section 9.4, RiboGene's
obligation under Section 2.9 shall terminate immediately upon termination of
this Agreement.
X. MISCELLANEOUS
10.1 Notices All notices required or permitted hereunder shall be
transmitted, or at least immediately affirmed, in writing by facsimile, followed
by confirmation of that facsimile either by registered or
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the Commission. Confidential treatment has been requested with respect to
the omitted portions.
36
certified mail, postage prepaid, return receipt requested, or by overnight
courier, addressed as follows, or to such other address as may be designated
from time to time by notice given by the respective party:
If to Xxxxxx: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx 00000-0000
Facsimile No.: (000) 000-0000
Attention: V.P., Anti-Infective Discovery, PPD R&D
cc: Vice President, Pharmaceutical Discovery
cc: Legal Division
If to RiboGene: RiboGene, Inc.
00000 Xxxxx Xxxxxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Facsimile No.: (000) 000-0000
Attention: President and CEO
10.2 Independence of Parties The status of each party under this
Agreement is that of an independent contractor, and neither party has the right
or authority to assume or create any obligation, accept legal process, make
commitments, incur any charges or otherwise bind or act on behalf of the other
or limit the other in any manner whatsoever, except as expressly stated herein.
Neither this Agreement nor any act hereunder shall be construed as constituting
the foundation of a partnership, association, agency, joint venture or any other
entity.
10.3 Impact on Other Relationships Neither the existence of this
Agreement nor the relationship of the parties hereunder shall impede either
party from engaging in any Independent activity, or, except as provided in
Section 2.9, as modified by Section 2.10, from entering into or continuing any
agreement with any third party directed to screening activities and commercial
candidate compound identification.
10.4 No Third-Party Beneficiaries No person or entity not a party to
this Agreement, including any employee of either party to this Agreement, shall
have or acquire any rights by reason of this Agreement,
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nor shall any party have any obligations or liabilities to such person or entity
by reason of this Agreement, except as provided under the provisions of Article
VIII.
10.5 No Waiver Failure by either party to enforce, or delay in
exercising, or partial exercise of any covenants or rights or remedies under
this Agreement shall not be deemed or construed as a waiver of such rights nor
shall a waiver by either party in one or more instances be construed as
constituting a continuing waiver or as a waiver in other or subsequent
instances.
10.6 Merger Clause This Agreement constitutes the complete and entire
understanding between the parties with respect to the screening and lead
identification activities anticipated hereunder, superseding and replacing all
prior oral or written agreements (except for the accrued rights and obligations
of the June 8, 1995 Confidential Disclosure Agreement and June 7, 1995 Materials
Transfer Agreement between the parties), communications, representations,
proposals, or negotiations specifically relating to the activities hereunder and
subject matter hereof. No change or addition to or variation or amendment of
this Agreement, nor any cancellation or waiver of any of the terms or provisions
hereof, nor any alteration or modification of any of the terms and conditions
hereof, shall be effective or valid and binding on either party unless in
writing and signed by a duly-authorized representative of each party.
10.7 Alternative Dispute Resolution The parties shall attempt to
amicably resolve disputes arising between them regarding the validity,
construction, enforceability or performance of the terms of this Agreement, and
any differences or disputes in the interpretation of the rights, obligations,
liabilities and/or remedies hereunder, which have been identified in a written
notice from one party to the other, by good faith settlement discussions between
their respective representatives. If the parties have failed to satisfactorily
resolve the dispute or difference after receipt of such written notice and
twenty-eight (28) calendar days having expired without the parties having
reached a satisfactory resolution, either party may initiate Alternative Dispute
Resolution ("ADR") procedures, during which each party shall have the right to
be
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represented by counsel, for resolution of all such disputes.
A. To begin an ADR proceeding, a party shall provide written notice to the
other party of the issues to be resolved by ADR. Within fourteen (14)
calendar days after its receipt of such notice, the other party may, by
written notice to the party initiating the ADR, add additional issues to
be resolved within the same ADR.
B. Within twenty-one (21) calendar days following receipt of the original
ADR notice, the parties shall select a mutually acceptable neutral to
preside in the resolution of any disputes in this ADR proceeding. If the
parties are unable to agree on a mutually acceptable neutral within such
period, either party may request the President of the CPR Institute for
Dispute Resolution ("CPR"), 000 Xxxxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx,
Xxx Xxxx 00000, to select a neutral pursuant to the following
procedures:
(a) The CPR shall submit to the parties a list of not less
than five (5) candidates, believed qualified to undertake
an ADR relating to the subject matter in dispute, within
fourteen (14) calendar days after receipt of the request,
along with a Curriculum Vitae for each candidate. No
candidate shall be an employee, director, or shareholder
of either party or any of their subsidiaries or
affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her
Impartiality.
(c) Each party shall number the candidates in order of
preference (with the number one (1) signifying the
greatest preference) and shall deliver the list to the
CPR, within seven (7) calendar days following receipt of
the list of candidates. If a party believes a conflict of
interest exists regarding any of the candidates, that
party shall provide a written explanation of the conflict
to the CPR along with its list showing its order of
preference for the candidates. Any party failing to return
a list of preferences on time shall be deemed to
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have no order of preference.
(d) If the parties collectively have identified fewer than
three (3) candidates deemed to have conflicts, the CPR
immediately shall designate as the neutral the candidate
for whom the parties collectively have indicated the
greatest preference. If a tie should result between two
(2) candidates, the CPR may designate either candidate. If
the parties collectively have identified three (3) or more
candidates deemed to have conflicts, the CPR shall review
the explanations regarding conflicts and, in its sole
discretion, may either (i) immediately designate as the
neutral the candidate for whom the parties collectively
have indicated the greatest preference, or (ii) issue a
new list of not less than five (5) candidates, in which
case the procedures set forth in subparagraphs B(a) - B(d)
shall be repeated.
C. No earlier than twenty-eight (28) calendar days or later than fifty-six
(56) calendar days after selection, the neutral shall hold a hearing to
resolve each of the issues identified by the parties. The ADR proceeding
shall take place at a location agreed upon by the parties. If the
parties cannot agree, the neutral shall designate a location other than
the principal place of business of either party or any of their
subsidiaries or affiliates.
D. At least seven (7) calendar days prior to the hearing, each party shall
submit the following to the other party and the neutral:
(a) a copy of all exhibits on which such party intends to
rely in any oral or written presentation to the neutral;
(b) a list of any witnesses such party intends to call at the
hearing, and a short summary of the anticipated testimony
of each witness;
(c) a proposed ruling on each issue to be resolved, together
with a request for a specific damage award or other remedy
for each issue. The proposed rulings and remedies
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shall not contain any recitation of the facts or any legal
arguments and shall not exceed one (1) page per issue.
(d) a brief in support of such party's proposed rulings and
remedies, provided that the brief shall not exceed twenty
(20) pages. This page limitation shall apply regardless of
the number of issues raised in the ADR proceeding.
Except as expressly set forth in subparagraphs D(a) - D(d), no discovery
shall be required or permitted by any means, including depositions,
interrogatories, requests for admissions, or production of documents.
E. The hearing shall be conducted on two (2) consecutive days and shall be
governed by the following rules:
(a) Each party shall be entitled to five (5) hours of hearing
time to present its case. The neutral shall determine
whether each party has had the five (5) hours to which it
is entitled.
(b) Each party shall be entitled, but not required, to make an
opening statement, to present regular and rebuttal
testimony, documents or other evidence, to cross-examine
witnesses, and to make a closing argument.
Cross-examination of witnesses shall occur immediately
after their direct testimony, and cross-examination time
shall be charged against the party conducting the
cross-examination.
(c) The party initiating the ADR shall begin the hearing and,
if it chooses to make an opening statement, shall address
not only issues it raised but also any issues raised by
the responding party. The responding party, if it chooses
to make an opening statement, also shall address all issues
raised in the ADR. Thereafter, the presentation of regular
and rebuttal testimony and documents, other evidence, and
closing arguments shall proceed in the same sequence.
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(d) Except when testifying, witnesses shall be excluded from
the hearing until closing arguments.
(e) Settlement negotiations, including any statements made
therein, shall not be admissible under any circumstances.
Affidavits prepared for purposes of the ADR hearing also
shall not be admissible. As to all other matters, the
neutral shall have sole discretion regarding the
admissibility of any evidence.
F. Within seven (7) calendar days following completion of the hearing, each
party may submit to the other party and the neutral a posthearing brief
in support of its proposed rulings and remedies, provided that such
brief shall not contain or discuss any new evidence and shall not exceed
ten (10) pages. This page limitation shall apply regardless of the
number of issues raised in the ADR proceeding.
G. The neutral shall rule on each disputed issue within fourteen (14)
calendar days following completion of the hearing. Such ruling shall
adopt in its entirety the proposed ruling and remedy of one of the
parties on each disputed issue but may adopt one party's proposed
rulings and remedies on some issues and the other party's proposed
rulings and remedies on other issues. The neutral shall not issue any
written opinion or otherwise explain the basis of the ruling.
H. The neutral shall be paid a reasonable fee plus expenses. These fees and
expenses, along with the reasonable legal fees and expenses of the
prevailing party (including all expert witness fees and expenses), the
fees and expenses of a court reporter, and any expenses for a hearing
room, shall be paid as follows:
(a) If the neutral rules in favor of one party on all disputed
issues in the ADR, the losing party shall pay 100% of such
fees and expenses.
(b) If the neutral rules in favor of one party on some issues
and the other party on other issues, the neutral shall
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issue with the rulings a written determination as to how
such fees and expenses shall be allocated between the
parties. The neutral shall allocate fees and expenses in a
way that bears a reasonable relationship to the outcome of
the ADR, with the party prevailing on more issues, or on
issues of greater value or gravity, recovering a
relatively larger share of its legal fees and expenses.
I. The rulings of the neutral and the allocation of fees and expenses shall
be binding, non-reviewable, and non-appealable, and may be entered as a
final judgment in any court having jurisdiction.
J. Except as provided in paragraph I or as required by law, the existence
of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and
briefs), and the rulings shall be deemed Confidential Information. The
neutral shall have the authority to impose sanctions for unauthorized
disclosure of Confidential Information.
10.8 Headings. Article and Section headings are inserted in this
Agreement for convenience of reference only and no construction, meaning,
interpretation or inference shall be derived from them.
10.9 Governmental Compliance and Effect of Invalidity. This Agreement and
performance hereunder is subject to the restrictions, limitations, terms and
conditions of all applicable governmental regulations, approvals and clearances.
If any term or provision of this Agreement is held invalid, illegal or
unenforceable in any respect, for any reason, that invalidity, illegality or
unenforceability shall not affect any other term or provision hereof, and this
Agreement shall be interpreted as if such term or provision, to the extent the
same shall have been held to be invalid, illegal or unenforceable, had never
been contained herein, with the other provisions of this Agreement remaining in
force.
10.10 Assignability. This Agreement and the rights, obligations,
privileges, and interests hereof may not be assigned by either party, except
that either party may assign this Agreement and rights and interests, in whole
or in part, (i) to any of its Affiliates, provided that the assigning party
continues to guarantee the performance of such
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43
Affiliate(s), or (ii) with the consent of the other party, which consent shall
not be unreasonably withheld, to any purchaser of all or substantially all of
its stock or assets of such party (including the assets associated with the
Research Program), or to any acquirer or successor corporation resulting from
any merger or consolidation with or into such successor corporation.
10.11 Succession. This Agreement and the rights and obligations granted
and undertaken hereunder shall be binding upon and enure to the benefit of the
parties hereto, and their permitted assign(s), successor(s), trustee(s) or
receiver(s) in bankruptcy.
10.12 Government Compliance. RiboGene and Abbott shall comply with all
federal, state, and local laws, ordinances and regulations applicable to the
shipment, handling, storage, testing, use, development, sale and/or disposal of
any compound or peptide hereunder.
10.13 Governing Law. The validity, construction, and performance of this
Agreement shall be governed by and interpreted in accordance with the laws of
the State of New York, U.S.A., excluding its choice of laws provisions.
IN WITNESS WHEREOF, authorized representatives of the parties have duly
executed this Agreement in duplicate.
RIBOGENE, INC XXXXXX LABORATORIES
By: /s/ XXXXXXX X. XXXXXXXXX By: /s/ XXXXXX X. XXXXXXX
------------------------------ ----------------------------------------
Name: Xxxxxxx X. Xxxxxxxxx Name: Xxxxxx X. Xxxxxxx
Title: Chairman, President & CEO Title: President and Chief Operating Officer
--------------------------- --------------------------------------
Date: April 26, 1996 Date: April 24, 1996
--------------------------- --------------------------------------
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EXHIBIT A
COUNTRY APPLICATION NO. FILING DATE PATENT NO. ISSUE DATE
U.S 08/328,258 10/24/93
(PCT) 94/12,161 10/14/94
45
EXHIBIT I
ABBOTT/RIBOGENE ANNUAL RESEARCH PLAN
FOR ANTIFUNGAL COMPOUND DEVELOPMENT
(April, 1996-April, 1997)
This Exhibit represents the initial Annual Research Plan, stating the objectives
and describing the activities for the first Contract Year of the Research
Program under the Abbott-RiboGene Research Agreement of April, 1996.
Modifications to this Program will occur as the result of further discussions of
the Joint Management Team (JMT). It is understood that the conditions and other
provisions of the Research Agreement apply and control this Exhibit in all
respects.
RESEARCH GOALS
The Abbott/RiboGene Research Program shall be focused on, but not limited to,
research and development directed to both oral and intravenous forms of
compounds, which have broad spectrum antifungal activity, for use in treatment
of systemic fungal infections. An objective of this Research Program during the
initial phase (the period after the Research Agreement is signed, but before the
JMT has convened) of the Agreement is to capitalize on the full potential of
RiboGene's proprietary and novel approaches to developing inhibitors of fungal
protein translation.
RESEARCH PROGRAM COMPONENTS
PRIMARY SCREENS
It shall be the priority of RiboGene scientists to complete the screening of
RiboGene libraries through RiboGene's GCN4 and yEF-3 primary translation
inhibition screening assays. Upon signing of the Research Agreement, Abbott will
begin to provide compounds from Xxxxxx'x library to RiboGene for screening in
these same two primary assays. The rate, at Xxxxxx'x option, at which these
compounds will be provided to RiboGene shall be targeted to providing RiboGene
with samples of all compounds to be tested from the Abbott library over a 12
month period.
46
SECONDARY SCREENS
Compounds identified as reactive in the primary screens will undergo further
testing at RiboGene and at Abbott. RiboGene will perform in vitro translation
testing using both fungal and mammalian translation systems. The spectrum of
antifungal activity for compounds identified by the primary screens will be
determined at Abbott and will include, but not be limited to, testing vs. [*]
species.
TERTIARY SCREENS
Compounds identified by the JMT as candidates for tertiary screening will be
tested at Abbott in in vivo models of acute and chronic fungal infections. In
addition, Abbott will perform appropriate pharmacokinetic and acute toxicity
studies on these compounds.
CHEMISTRY
The JMT shall determine which RiboGene Compounds should be structurally
modified at Abbott using traditional medicinal chemistry and/or combinatorial
chemistry methods to attempt to improve the pharmaceutical properties of these
compounds. All compounds which represent modifications of RiboGene Compounds
derived from these approaches shall be evaluated for protein synthesis
inhibition and antifungal activity at both RiboGene and Abbott.
DEVELOPMENT OF NEW ANTIFUNGAL PRIMARY SCREENING ASSAYS RiboGene will initiate
and direct and Abbott will participate in planning research toward the
development of new translation-based primary screening assays which identify [*]
inhibitors and compounds which suppress [*] during the first 8 months of the
Research Program. The goal during this period is to bring on line 2 additional
primary screens, one within 6 months, and one within 8 months from the Inception
of the Research Program.
DATA MANAGEMENT Abbott and RiboGene shall organize an electronic system of
Research Program data collection, management and sharing within a period not to
exceed 45 days from the beginning of the Research Program. Abbott shall
communicate such information regarding its computerized data
collection/management systems and software for
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the omitted portions.
47
recording and tracking data to allow RiboGene to establish Abbott-compatible
systems within its laboratories and to develop an electronic data sharing system
for communicating information relating to antifungal compounds which result from
the Research Program. This system is also intended to facilitate rapid and
complete integration of data generated in RiboGene's translation inhibition
antifungal screening of Abbott Compounds into the Abbott library database.
Certain biological and chemical data concerning RiboGene Compounds and certain
Abbott Compounds, for which there are no previous restrictions to other Abbott
or confidential third party collaborations, may also be made available to
RiboGene through this database on a confidential basis. Similarly, Abbott shall
treat as confidential, and not disclose to a third party without prior consent
from RiboGene, confidential information provided to this database by RiboGene.
RiboGene will ensure that they have in place appropriate instrumentation and
software to facilitate rapid and timely communication of data between RiboGene
and Abbott.
STRATEGIC PROJECT MANAGEMENT
In order to fully capitalize on the diversity of backgrounds, creativity and
intellectual contributions of all parties, the JMT and possibly additional
designates of each party shall meet together with the RiboGene Scientific
Advisory Board to discuss antifungal drug development strategies and related
scientific issues within the first 90 days after the Research Agreement is
signed.
Certain antifungal compounds may be identified by the JMT as potential clinical
candidates based on scientific evidence. The ultimate decision to move such a
compound forward into clinical trials shall be the sole responsibility of
Abbott and will include, but not necessarily be limited to, an evaluation of the
compound's competitive efficacy and safety profile, formulation of the
compound, the degree of difficulty and cost of manufacturing the particular
compound and the antifungal marketplace. Abbott shall inform RiboGene in a
timely manner regarding its decisions on clinical development of antifungal
compounds resulting from the Research Program.
COMMUNICATION
Abbott and RiboGene scientists will communicate by phone, telefax, mail, or
through approved and properly protected computerized networks in order to insure
timely exchange of information between parties. Hard copies of all data and
overheads shall be provided
