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Exhibit 10.1
ABBOTT-RIBOGENE LICENSE AGREEMENT
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Table of Contents
PAGE
I. DEFINITIONS................. .......................................... 5
1.1 Abbott Compound........................................................ 5
1.2 Abbott Patent Rights................................................... 6
1.3 Affiliate.............................................................. 7
1.4 Calendar Year and Calendar Quarter or Quarter.......................... 7
1.5 Confidential Information............................................... 7
1.6 Field.................................................................. 8
1.7 IND.................................................................... 8
1.8 Joint Management Team or JMT........................................... 8
1.9 Know-how............................................................... 8
1.10 NDA.................................................................... 9
1.11 Net Sales of Single Active Product(s).................................. 9
1.12 Not Sales of Combination Product(s).................................... 10
1.13 Net Sales of Delivery System Product(s)................................ 11
1.14 Not Sales of Pharmaceutical Products................................... 12
1.15 Net Sales of Plant Protection Products................................. 12
1.16 Net Sales of Diagnostic Products....................................... 12
1.17 Not Sales.............................................................. 12
1.18 Phase III Studies...................................................... 13
1.19 Product................................................................ 13
1.20 Program Inventions and Joint Program Inventions........................ 13
1.21 Research Agreement..................................................... 14
1.22 Research Program....................................................... 14
1.23 Research Term.......................................................... 14
1.24 RiboGene Compound...................................................... 14
1.25 RiboGene Intellectual Property........................................ 15
1.26 RiboGene Lead......................................................... 15
1.27 RiboGene Patent Rights................................................ 15
1.28 Sale or Sold and First Commercial Sale................................. 16
1.29 Valid Claim............................................................ 16
II. LICENSE GRANTS ........................................................ 17
2.1 Research and Development Purposes...................................... 17
2.2 Program Inventions..................................................... 17
2.3 Compounds ............................................................. 17
III. MILESTONE AND ROYALTY PAYMENTS......................................... 18
3.1 Milestone Payments..................................................... 18
3.2 Royalty Payments....................................................... 19
3.3 Uses Within Xxxxxx Xxxxxx Affiliates, and/or Abbott Sublicensees ...... 22
IV. RECORDS AND ROYALTY PAYMENTS ............................................... 22
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4.1 Records................................................................ 22
4.2 Exchange Calculation................................................... 23
4.3 How Paid............................................................... 23
4.4 Royalty Statement...................................................... 23
4.5 Withheld Taxes......................................................... 24
V. PATENT RESPONSIBILITIES................................................ 24
5.1 RiboGene Patent Prosecution and Maintenance............................ 24
5.2 Program Invention Patent Prosecution and Maintenance................... 24
5.3 Infringement Defense................................................... 25
5.4 Patent Infringement by Third Parties................................... 25
5.5 Patent Marking......................................................... 26
5.6 Extensions............................................................. 26
VI. PRODUCT DEVELOPMENT AND PROMOTION ..................................... 26
6.1 Development and Approvals ............................................. 26
6.2 Trademarks ............................................................ 26
6.3 Notification of First Commercial Sale ................................. 27
VII. CONFIDENTIALITY ....................................................... 27
7.1 Confidentiality and Nonuse............................................. 27
7.2 Required Disclosure.................................................... 27
7.3 Return of Confidential Information..................................... 28
7.4 Nondisclosure of Third Party Confidential Information.................. 28
7.5 Publicity.............................................................. 28
7.6 Permitted Disclosure................................................... 28
VIII. WARRANTIES AND LIMITATIONS ON RIGHTS................................... 29
8.1 RiboGene Warranties.................................................... 29
8.2 Limitation on Warranties............................................... 29
8.3 Disclaimer............................................................. 29
8.4 Limitations on Rights.................................................. 30
IX. LIABILITIES AND INDEMNITY ............................................. 30
9.1 Liabilities............................................................ 30
9.2 Indemnification........................................................ 31
9.3 Abbott Indemnification................................................. 31
X. TERM AND TERMINATION .................................................. 32
10.1 Term................................................................... 32
10.2 Possible Extension..................................................... 32
10.3 Termination Without Breach............................................. 32
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10.4 Effect of Breach ...................................................... 32
10.5 Effect of Bankruptcy or Agreement Revision ............................ 33
10.6 Consequences of Termination ........................................... 33
XI. MISCELLANEOUS ......................................................... 33
11.1 Notices ............................................................... 33
11.2 Independence of Parties................................................ 34
11.3 Impact on Other Relationships.......................................... 34
11.4 No Third-Party Beneficiaries........................................... 34
11.5 No Waiver.............................................................. 34
11.6 Merger Clause.......................................................... 34
11.7 Alternative Dispute Resolution......................................... 35
11.8 Headings............................................................... 40
11.9 Governmental Compliance and Effect of Invalidity....................... 40
11.10 Assignability.......................................................... 40
11.11 Succession............................................................. 40
11.12 Government Compliance.................................................. 40
11.13 Governing Law.......................................................... 40
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LICENSE AGREEMENT
This License 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 has a number of compounds already identified as
possessing fungicidal and/or fungistatic activity, and is experienced in
screening compounds and materials acting through a eukaryotic translation
mechanism, and Abbott is experienced in the discovery and development of
pharmaceutical products, including those with antifungal properties, and in
obtaining regulatory approval for and in commercializing such pharmaceutical
products; and
WHEREAS, the parties have entered into a Research Agreement (as defined
hereinbelow) under which they will collaborate in a Research Program (as defined
hereinbelow) directed to accelerating the discovery of new pharmaceutical and/or
plant protection products possessing antifungal activity and/or new diagnostic
products related to conditions caused by fungal infections and/or diseases, and
they desire that Abbott have a license, under the terms herein, for evaluation
and possible development and commercialization of Abbott Compounds (as defined
hereinbelow) and/or RiboGene Leads (as defined hereinbelow) for pharmaceutical,
diagnostic and/or plant protection uses relating to mycotic (fungal) infections
and/or diseases.
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
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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; 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) has demonstrated 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(50) 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; or
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 "Abbott Patent Rights" shall mean all patent applications filed in
any country of the world, including all divisions, continuations and
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* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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continuations-in-part thereof, and all patents issuing therefrom, which are
owned, controlled or licensed to Abbott during the term of this Agreement,
including all additions, registrations, confirmations, renewals, extensions,
supplemental protection certificates, reexaminations and reissues thereof, that
claim one or more Abbott Compounds.
1.3 "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 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.
1.4 "Calendar Year" shall mean any consecutive twelve (12)= month
period commencing on any January 1 and ending on the immediately-following
December 31, during the term of this Agreement. "Calendar Quarter" or "Quarter"
shall mean a three (3)-month period commencing on January 1, April 1, July I or
October 1, during the term of this Agreement.
1.5 "Confidential Information" shall mean all valuable, confidential
technical and/or commercial information, know-how or trade secrets, including
but not necessarily limited to development and/or commercialization plans and
strategies, marketing and sales information, patent applications not yet
published, and other information, data or plans relating to a party, which
information is 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
and/or in another intangible form, and identified as confidential,
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then subsequently summarized and reduced to a writing or to another physical
form, marked "Confidential" and provided 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 is subsequently independently
developed by or for the Receiving Party, without benefit of the Disclosing
Party's Confidential Information; or
(e) is properly provided, without restriction, to the Receiving Party by
an independent third party; or
(f) is disclosed by the original Disclosing Party on a nonconfidential
basis to any independent third party.
1.6 "Field" shall mean the treatment, mitigation, cure, prevention,
detection, and/or monitoring of fungal (mycotic) infections or diseases, not
including those caused by Pneumocystis carinii, in humans, animals and/or plant
protection.
1.7 "IND" (Investigational New Drug Application) means an application
for an "Investigational Exemption for a New Drug' filed with the United States
Food and Drug Administration or any successor' drug-regulatory entity thereto
("FDA") or the corresponding application filed with the equivalent
pharmaceutical regulatory agency in France, Germany, Great Britain, Italy or
Japan.
1.8 "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.
1.9 "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
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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 6.3 and/or Section
6.4 of the Research Agreement, except for Program Inventions for which Abbott
does not have a nonexclusive license, according to the provisions of Section 6.4
of the Research Agreement. 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 of the Research Agreement.
1.10 "NDA" (New Drug Application) means an application submitted to the
FDA or the equivalent pharmaceutical regulatory agency in the European Union
(or, if submitted individually until 0000, Xxxxxx, Xxxxxxx, Great Britain or
Italy) 'or Japan, which contains complete details of the manufacture and testing
of a new drug, for purposes of obtaining regulatory approval to market such new
drug in such country or region, for a particular indication.
1.11 "Net Sales of Single Active Product(s)", by country, for each
particular Single Active Product (as defined immediately below), shall mean the
total or gross invoiced Sales (as defined hereinbelow) in a country, for the
applicable period, of Product(s) (as defined hereinbelow),
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for which one or more Abbott Compounds and/or RiboGene Leads are the sole
therapeutic or prophylactic active ingredient(s) ("Single Active product(s)"),
by Xxxxxx, Xxxxxx Affiliate, or Abbott sublicensee to non-Affiliate
distributor(s) or other third parties, less, where factually applicable,
"Deductions", according to Xxxxxx'x standard accounting practices, for:
(i) direct and indirect credits, allowances according to Abbott standard
practices, adjustments and refunds, including price adjustments, rejections and
returns of defective, damaged, outdated or recalled Products;
(ii) offered and taken trade and cash discounts, rebates, commissions,
charge-backs granted to drug wholesalers, management fees paid to group
purchasing organizations, price reductions, retroactive or otherwise, imposed by
governments or government agencies, and distribution fees in amounts customary
to the trade and as required to do business in that country;
(iii) importation, handling, special outbound packing or transportation
and insurance charges separately billed to the customer or prepaid and directly
chargeable to the Sale of Products; and
(iv) sales, excise, use, turnover, inventory, value-added and similar
taxes and/or duties specifically incurred with or imposed upon Sales of
Products, but not including net income tax.
1.12 "Net Sales of Combination Product(s)", by country, for each
particular Combination Product (as defined immediately below), shall mean, for
the applicable period, the lesser of (a) the gross invoiced Sales of the
particular Combination Product containing one or more other therapeutic or
prophylactic active ingredient(s) in addition to one or more Abbott Compounds
and/or RiboGene Leads ("Combination Product") by Xxxxxx, Xxxxxx Affiliate, or
Abbott sublicensee to non-Affiliate distributor(s) or other third parties, in
such country, less any applicable Deductions (as listed above in Section 1.11),
and (b) an amount determined by multiplying the number of grams of Abbott
Compound(s) and/or RiboGene Lead(s) sold in the form of Combination Product to
non-Affiliate distributor(s) or other third parties, in that country, for the
applicable period, by the average price per gram, in such country, of the
corresponding Single Active Product Sold to non-Affiliate distributor(s) or
other third parties in that country, which average price per gram shall
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be computed by dividing the Net Sales of such Single Active Product to
non-Affiliate distributor(s) or other third parties in that country, less any
applicable Deductions, for the applicable period, by the number of grams of
Abbott Compound(s) and/or RiboGene Lead(s) contained in such Net Sales.
If there were no Sales of the corresponding Single Active Product during the
applicable period in that country, then Net Sales of the particular Combination
Product by calculation (b) above shall be determined using the average price per
gram, in all countries in which a Valid Claim exists and the Single Active
Product is Sold, of such Single Active Product. If there were no Sales of the
corresponding Single Active Product during the applicable period in any country
in which a Valid Claim exists, then Net Sales of the particular Combination
Product, in that country, by calculation (b) above shall be determined by
multiplying the gross invoiced Sales of Combination Product, less any applicable
Deductions, by the standard production cost of Abbott Compound(s) and/or
RiboGene Lead(s) in the Combination Product (averaged, if necessary, to reflect
the proportionate standard production costs of the pro-rata share of each Abbott
Compound and/or RiboGene Lead contained in the Product) divided by the sum of
the standard production costs of all active ingredients in the Combination
Product.
1.13 "Net Sales of Delivery System Product(s)", by country, for each
particular Delivery System Product (as defined immediately below) shall mean,
for the applicable period, the number of units of either Single Active Product
or Combination Product, as applicable, sold in a drug delivery system comprising
the particular Single Active Product or Combination Product along with a device,
equipment, instrumentation or other components (not solely container(s) or
packaging) designed to accomplish or assist in the administration of such Single
Active Product or Combination Product, e.g., the Abbott ADD-Vantage(R) System
("Delivery System Product"), multiplied by the average price per unit of
Single Active Product or Combination Product, as applicable, when sold
separately to non-Affiliate distributor(s) or other third parties in that
country, less applicable Deductions (as listed above in Section 1.11), for the
applicable period.
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If there were no Sales of a Single Active Product or a Combination Product that
is incorporated within the particular Delivery System Product, as applicable,
during the particular period, in that country, then Net Sales of the specific
Delivery System Product shall mean the total or gross invoiced Sales in the
country, for the applicable period, of Delivery System Product to non-Affiliate
distributor(s) or other third parties, less, where factually applicable,
Deductions (as listed above in Section 1.11) and less an amount which represents
the proportionate economic value added by the delivery system, based on such
factors and in an amount determined by mutual agreement, using, if applicable,
existing precedents for the same or comparable delivery system(s).
1.14 "Net Sales of Pharmaceutical Products", shall mean the sum of the
aggregate Net Sale's of Single Active Product(s), the aggregate Net Sales of all
Combination Product(s) and the aggregate Net Sales of all Delivery System
Product(s), in each case for human pharmaceutical purposes, for the particular
period.
1.15 "Net Sales of Plant Protection Products", by country, shall mean
the Net Sales of Single Active Product(s), the Not Sales of all Combination
Product(s) and the Net Sales of all Delivery System Product(s), in each case for
plant protection purposes in that country, for the particular period.
1.16 "Net Sales of Diagnostic Products", by country, shall mean, for a
particular period, the total or gross invoiced Sales in that country, for that
period, of Product(s) for which the gross invoiced price includes an amount to
compensate Abbott, an Abbott Affiliate and/or Abbott sublicensee for the
amortized cost of an Instrument system, including services, and/or other
equipment supplied without additional charge to a customer, less any applicable
Deductions (as listed in Section 1.11), less the amount of the Sales reasonably
and demonstrably attributable solely to the instrument system, Including
services, and/or other equipment supplied to the customer, in accordance with
standard accounting practices of Abbott, consistently applied.
1.17 "Net Sale" when used without further modification, shall mean the
aggregate of Net Sales of Single Active Product(s), Net Sales of
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Combination Product(s), Net Sales of Delivery System Product(s), Net Sales of
Plant Protection Products and Net Sales of Diagnostic Products.
1.18 "Phase III Studies" shall mean a series of controlled pivotal
clinical trials, after completion of preliminary efficacy and dose-ranging
studies and after adequate safety data has been established for a Product, that
are necessary to obtain sufficient confirmatory efficacy and safety data for the
preparation and submission of an NDA for such Product for the human therapeutic
indication being investigated by the trials, and which are planned to involve a
sufficient number of patients who suffer from the condition for which the NDA is
to be submitted for submission of such NDA.
1.19 "Product" shall mean (a) any pharmaceutical formulation(s)
containing one or more Abbott Compounds and/or RiboGene Leads 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.
1.20 "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
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one individual of which is an employee, at the time of the inventive
contribution of such individual, of the other party hereto.
1.21 "Research Agreement" means the Research Agreement between RiboGene
and Abbott of even date which relates to the Research Program.
1.22 "Research 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 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.
1.23 "Research Term" shall mean the period beginning on the Effective
Date of the Research Agreement and expiring on the third (3rd) anniversary of
such date, unless otherwise terminated according to the provisions of Article IX
of the Research Agreement or extended by mutual written consent of the parties.
1.24 "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; or
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
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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.
1.25 "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 of the Research Agreement 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 of
the Research Agreement, or extensions or revisions of any of the above based on
jointly-owned Joint Program Inventions according to the provisions of Section
6.4 of the Research Agreement.
1.26 "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
equal to or less than [*] 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 [*] periods following the termination or expiration of
the Research Term, Xxxxxx has not Identified such compound or material to
RiboGene as among the [*] RiboGene Leads that Xxxxxx has selected as being
those to which Xxxxxx desires to retain exclusive rights, to the extent that
RiboGene can grant such exclusive rights.
1.27 "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
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* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
the omitted portions.
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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 of the Research Agreement,
but do not include patent applications and patents assigned to RiboGene,
according to the provisions of Section 6.4 of the Research Agreement, in which
Xxxxxx has a nonexclusive license, under the provisions of Section 6.4. RiboGene
Patent Rights include, but are not necessarily limited to, those patent
applications and/or patents identified in Exhibit A, attached to this License
Agreement and updated by RiboGene, as justified by filing, prosecution, issuance
and/or maintenance circumstances, and reattached hereto.
1.28 "Sale" or "Sold" shall mean the transfer for value (cash and/or
otherwise) in an arm's-length transaction of a Product in any country by Xxxxxx,
Xxxxxx Affiliate, or Xxxxxx sublicensee to a nonaffiliated third-party
distributor, agent or end user after obtaining all necessary government
approvals applicable to such sale. Sales shall be accounted for when shipped,
and credits and refunds shall be accounted for when booked by Xxxxxx in
accordance with Xxxxxx'x standard accounting practices. The date of the "First
Commercial Sale" in any country shall be the date of the shipment for such Sale.
1.29 "Valid Claim" shall mean a claim of any issued, unexpired patent
contained within RiboGene Patent Rights or Xxxxxx Patent Rights, which has not
been ruled invalid or unenforceable by a final, unappealed or unappealable
decision of a court of competent jurisdiction or of an administrative agency
having authority over patents and which covers an Xxxxxx Compound or RiboGene
Lead or which covers the use of an Xxxxxx Compound or RiboGene Lead, which use
claim effectively precludes any sale of a compound or material, which is
identical to such Xxxxxx Compound or RiboGene Lead, by any third party, for any
human
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pharmaceutical, animal and/or diagnostic purpose in the Field.
II. LICENSE GRANTS
2.1 Research and Development Purposes RiboGene hereby grants to Xxxxxx
a nonexclusive, worldwide right and license Under RiboGene Intellectual
Property, with the right to grant sublicenses without RiboGene's approval to
Xxxxxx Affiliate(s) and otherwise with RiboGene's approval, which approval shall
not be unreasonably withheld, to identify, make, have made, import, modify, use,
develop, test and file for regulatory approval on Xxxxxx Compounds and/or
RiboGene Compounds for the benefit of Xxxxxx'x discovery, development and
commercial preparation of Xxxxxx Compounds and/or RiboGene Leads for use in the
Field.
2.2 Program Inventions RiboGene hereby grants to Xxxxxx a nonexclusive,
perpetual worldwide license to make, have made, import, use, and/or develop any
Program Invention(s), for which one or more employees of RiboGene is/are the
only Inventor(s) of such Program Invention and for which Xxxxxx has a
nonexclusive license, according to the provisions of Section 6.4 of the Research
Agreement, and, subject to the provisions of Section 9.5 of the Research
Agreement, a nonexclusive right and license, during the Research Term, to
practice any Program Invention and/or Joint Program Invention assigned to
RiboGene under the provisions of Section of 6.3 of the Research Agreement.
2.3 Compounds RiboGene hereby grants to Xxxxxx a perpetual, worldwide
right and license under RiboGene Intellectual Property, as applied specifically
and solely to Xxxxxx Compounds and/or RiboGene Leads, with the right to grant
sublicenses, to make, have made, modify, import, use, promote, offer to sell and
sell Xxxxxx Compounds and/or RiboGene Leads for any purpose. Notwithstanding the
grant above, such license shall expire three (3) years following the expiration
or termination of the Research Term with respect to every RiboGene Lead other
than the [*] identified by Xxxxxx to RiboGene as to be retained by Xxxxxx. This
license shall be sole and exclusive to Xxxxxx, except that, during the Research
Term, RiboGene shall also retain such rights under RiboGene Intellectual
Property as are necessary to fulfill the Research Program.
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III. MILESTONE AND ROYALTY PAYMENTS
3.1 Milestone Payments As consideration for the licenses and rights
granted in this Agreement, Xxxxxx shall make milestone payments to RiboGene, by
Product for human pharmaceutical use in the Field, for development of such
Product by Xxxxxx, Xxxxxx Affiliate or Xxxxxx sublicensee for such human
pharmaceutical purposes, as follows:
(a) [*] within twenty (20) business days from the filing date by
Xxxxxx, Xxxxxx Affiliate, or Xxxxxx sublicensee, of the first [*] with such
Product; and
(b) [*] within twenty (20) business days of the initiation of the
first [*] with such Product, but if, and only if, [*] for such Product and no
[*] not later than twenty (20) business days following Xxxxxx'x first [*] for
such Product, concurrent with the payment according to the provisions of Section
3.1(c); and
(c) [*] within twenty (20) business days from Xxxxxx'x first [*] of
such Product; and
(d) [*] within twenty (20) business days of the first [*] of such
Product.
All payments made hereunder shall be nonrefundable, but if the
particular Product is withdrawn from further development, from
commercialization, or from sale, and Xxxxxx substitutes a different Product with
a similar human pharmaceutical utility profile, as determined in reasonable good
faith by Xxxxxx, into the regulatory process in place of such withdrawn Product,
within four (4) years of the withdrawal of the earlier submission, Xxxxxx shall
receive credit for milestone payments previously made for the withdrawn Product
and shall be obligated to pay only that/those milestone payment(s) which had not
been made with respect to this substitute human pharmaceutical Product.
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Xxxxxx shall pay only one series of milestone payments for all human
pharmaceutical Products in the Field containing a specific Xxxxxx Compound or
RiboGene Lead, regardless of the number of dosage forms, formulations and/or
indications for which Xxxxxx develops and seeks marketing approval for such
Products.
All milestone payments made with respect to one or more Products hereunder shall
be fully creditable against twenty-five percent (25%) of the royalty payments
due for any particular royalty period, according to the provisions of Sections
3.2 and 4.3 hereof, with respect to Sales of such Product(s) until the milestone
payments have been fully credited and taken by Xxxxxx.
3.2 Royalty Payments. As additional consideration for the licenses and
rights granted in this Agreement, Xxxxxx shall pay, or in the case of Sales by
Xxxxxx Affiliate(s) and/or sublicensee(s), cause such Xxxxxx Affiliate(s)
and/or sublicensee(s) to pay, to RiboGene royalties on Net Sales of
Pharmaceutical Product(s) in the Field, by Xxxxxx, Xxxxxx Affiliate, or Xxxxxx
sublicensee, from the date of First Commercial Sale of any Product(s) Sold in a
pharmaceutical formulation for human use in the Field, on a country-by-country
basis in and for countries in which, but for this license, the Sale of such
Product(s) for human pharmaceutical use would infringe at least one Valid Claim,
for the life of the RiboGene or Xxxxxx patent(s) comprising such Valid Claim(s),
according to the following:
(a) on annual (Calendar Year) Net Sales of Pharmaceutical Products
worldwide in the Field of up to and including an aggregate of [*], a royalty of
[*] of such Net Sales; plus
(b) on annual Net Sales of Pharmaceutical Products worldwide in the
Field of more than [*] but less than or equal to [*] a royalty of [*] of such
Net Sales; plus
(c) on annual Net Sales of Pharmaceutical Products worldwide in the
Field of more than [*] but less than or equal to [*] a royalty of [*] of such
Net Sales; plus
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(d) on annual Net Sales of Pharmaceutical Products worldwide in the
Field of more than [*] but less than or equal to [*] a royalty of [*] of such
Net Sales; plus
(e) on annual Net Sales of Pharmaceutical Products worldwide in the
Field of more than [*] a royalty of [*] of such Net Sales.
As an example, if Xxxxxx, Xxxxxx Affiliates, and/or Xxxxxx
sublicensees have aggregate Net Sales of Pharmaceutical Products in the Field in
a given Calendar Year equivalent to [*] Xxxxxx would owe RiboGene royalties of
[*] on the first [*] of such Net Sales (resulting in royalties due of [*], on
the second [*] of such Net Sales [*] on the next [*] of such Net Sales [*] on
the next [*] of Net Sales [*] on the final [*] of such Net Sales [*] for a total
of royalties due for such Calendar Year of [*].
If a Valid Claim does not or does not yet exist in a country in which a Product
is Sold In the Field, and for so long as no other sale of the same chemical or
biological entity is being made by any independent third party, Xxxxxx, or
Xxxxxx Affiliate(s) and/or sublicensee(s), shall pay to RiboGene royalties on
Net Sales of Pharmaceutical Products in the Field, in such country, according to
the provisions above, but the amount used as "gross Invoiced Sales" in the
formulae of Sections 1.12 through 1.14, for purposes of calculating royalties in
such case(s), shall be one-half (1/2) of the actual gross invoiced Sales amount,
until such a Valid Claim exists in such country or until the expiration of three
(3) years from the First Commercial Sale in such country.
Notwithstanding the foregoing, after Xxxxxx has paid RiboGene a total of Eighty
million U.S. Dollars (USD80,000,000) in cumulative royalty payments, not
including creditable milestone payments, according to the provisions of Section
3.2 in connection with Xxxxxx'x, Xxxxxx Affiliates', and/or Xxxxxx'x
sublicensees' Sales of Product(s) In the Field,. Xxxxxx
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shall pay RiboGene [*] on all of Xxxxxx'x, Xxxxxx'x Affiliates' and/or Xxxxxx'x
sublicensees' Net Sales of Pharmaceutical Products in the Field, by country, for
the remainder of the term that a Valid Claim exists in that country.
As still additional consideration for the licenses and rights granted in this
Agreement, Xxxxxx shall pay to RiboGene royalties on Net Sales of Diagnostic
Product(s) in the Field, Net Sales of Plant Protection Product(s) in the Field
and Net Sales of Single Active Product(s), Net Sales of Combination Product(s)
and Net Sales of Delivery System Product(s) for animal uses in the Field, by
Xxxxxx, Xxxxxx Affiliate, or Xxxxxx sublicensee, from the date of first Sale of
any such Product(s) for such purposes, on a country-by-country basis in and for
countries in which at least one Valid Claim claiming one or more of the Xxxxxx
Compound(s) and/or RiboGene Lead(s) within such Product(s) or the use of such
Xxxxxx Compound(s) and/or RiboGene Lead(s) which provides Xxxxxx, Xxxxxx
Affiliate and/or Xxxxxx sublicensee exclusivity for the Sale of such Product(s)
for such purposes has issued, for the life of the RiboGene or Xxxxxx patent(s)
comprising such Valid Claim(s), according to the following:
(i) a royalty of [*] on annual (Calendar Year) Net Sales for such
purposes worldwide of up to and including an aggregate of [*]; plus
(ii) on annual Not Sales for such purposes worldwide of more than [*] a
royalty of [*] of such Net Sales.
In all cases, Xxxxxx shall pay only one royalty on the Sale of any individual
Product.
Still further, Xxxxxx shall owe RiboGene: (a) on the Sales of Products that are
approved, promoted and Sold for multiple indications, royalties, according to
the provisions of this Section 3.2, on only the portion of the Sales of such
Products comprising at least one Xxxxxx Compound and no RiboGene Lead which is
to or in the Field, as established by a recognized market research firm used by
Xxxxxx, according to Xxxxxx'x standard practices, and on all Sales of such
Products comprising at least one RiboGene Lead; (b) on Sales of Products that
are approved and Sold for one
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or more indications outside of the Field, full royalties, according to the
provisions of this Section 3.2, on the Sales of Products comprising at least one
RiboGene Lead, and no royalties on Sales of Products comprising at least one
Xxxxxx Compound but no RiboGene Lead.
3.3 Uses Within Xxxxxx, Xxxxxx Affiliates, and/or Xxxxxx Sublicensees
In the event that a Product is used for human pharmaceutical, veterinary
pharmaceutical, diagnostic or plant protection commercial purposes by Xxxxxx, or
an Xxxxxx Affiliate or Xxxxxx sublicensee, Net Sales for such transfer shall be
calculated as set forth in Sections 1.12 through 1.14, 1.16 and 1.17 above, and
royalties shall be calculated according to the provisions of Section 3.2, except
that the gross "sales" price for purposes of such calculation shall be the
average gross sales price for such Product Sold for such purposes in arms-length
Sales to non-Affiliate distributor(s) or customers by Xxxxxx, Xxxxxx Affiliate
or Xxxxxx sublicensee in the country in which the transfer and/or use occurred
during the Calendar Quarter in which such Product was transferred for the
particular purpose(s) to such entity.
IV. RECORDS AND ROYALTY PAYMENTS
4.1 RECORDS Xxxxxx shall, and shall cause Xxxxxx Affiliates, and
Xxxxxx sublicensees to, keep and maintain true and accurate records consistent
with the letter and spirit of this Agreement. Such records shall be consolidated
semiannually in Xxxxxx headquarters and open to inspection by an independent
certified public accountant selected by RiboGene, and reasonably acceptable to
Xxxxxx, that has been retained at RiboGene's expense. Such accountant may review
such records once in any Calendar Year within two (2) years after the royalty
period to which such records relate, during normal business hours, with at least
thirty (30) business days' written notice. Such accountant shall execute a
reasonable nondisclosure agreement with Xxxxxx prior to commencing any
inspection, and shall have the right to examine the records kept pursuant to
this Agreement solely for the purpose of verifying Xxxxxx'x royalty obligations
hereunder, and shall report the findings of such examination of records to
RiboGene as well as to Xxxxxx. If the audit shows that royalties actually due
exceed those previously reported by more than [*], Xxxxxx shall pay all
reasonable expenses of the audit.
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4.2. Exchange Calculation Royalties due shall be calculated on the
aggregate of Net Sales for the applicable purpose, by country, according to the
provisions of Section 3.2, in the national currency of each such country,
converted to U.S. dollars in accordance with Xxxxxx'x standard procedures for
converting Sales from the foreign currency in which the Sales were made, which
procedures shall conform to generally accepted accounting principles.
4.3. How Paid Royalties shall be paid quarterly to RiboGene by Xxxxxx
on Net Sales by Xxxxxx, Xxxxxx Affiliates, and/or Xxxxxx sublicensees, in U.S.
dollars within sixty (60) calendar days after the last day of March, June,
September and December during the term of this Agreement and within sixty (60)
calendar days, for domestic Sales, and ninety (90) calendar days, for
international Sales, after the expiration or termination of this Agreement to
fulfill obligations arising from any partial Quarter at the end of this
Agreement, using royalty rates. applicable under Section 3.2 to the aggregate of
total Calendar Year-to-date Net Sales by Xxxxxx, Xxxxxx Affiliate(s), and/or
Abbot sublicensee(s) through the relevant Quarter or partial Quarter, accruing
on Sales during the preceding Quarter. Royalty payments due to RiboGene
hereunder shall be, at Xxxxxx'x option, paid by electronic funds transfer or
wire transferred for the account of RiboGene, Inc. [*]
4.4. Royalty Statement Concurrently with Xxxxxx'x payment of its
royalty obligations to RiboGene, Xxxxxx shall mail to RiboGene, according to the
provisions of Section 11.1, a statement which shall reference the Calendar
Quarter and Calendar Year for which the payment was made and shall set forth the
payment made; each Product Sold by country in which a Valid Claim exists, and
all other countries until the expiration of [*] years from the First Commercial
Sale; the Net Sales for human pharmaceutical veterinary pharmaceutical,
diagnostic and/or plant protection purposes in that country, as applicable,
expressed in local currency; the exchange rates used; Net Sales by such country
and aggregated for all countries in which a Valid Claim exists, or as otherwise
due, according to the provisions of the third paragraph of
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Section 3.2, which relates to Sales in countries in which a Valid Claim does not
exist, expressed in U.S. dollars for the relevant Calendar Quarter; as well as
the respective Calendar Year-to-date total Net Sales, divided as by quarterly
report categories above, through the relevant Calendar Quarter; the applicable
royalty rate(s); and royalties payable in U.S. dollars for the relevant
Calendar Quarter.
4.5 Withheld Taxes Xxxxxx may withhold from all royalty payments any
taxes lawfully imposed and required to be withheld on such payments by the
government of any jurisdiction in which Xxxxxx, Xxxxxx Affiliate and/or Xxxxxx
sublicensee sells Product(s). All taxes so withheld shall be paid to the
appropriate government entity for the account of RiboGene and Xxxxxx shall
promptly forward to RiboGene all tax receipts evidencing payment of such taxes.
V. PATENT RESPONSIBILITIES
5.1 RiboGene Patent Prosecution and Maintenance RiboGene will, at its
expense, using counsel of its choice, diligently prosecute claims in and
maintain patent applications and patents included in RiboGene Patent Rights in
Australia, Canada, France, Germany, Great Britain, Italy, Japan, Mexico, Spain
and the United States, and other countries agreed upon in good faith by RiboGene
and Xxxxxx, and will timely provide Xxxxxx with copies of all relevant
documentation, which copies and information Xxxxxx shall treat as RiboGene
Confidential Information, in order to advise Xxxxxx of the prosecution of the
applications included in RiboGene Patent Rights. RiboGene may, at any time,
assign any patent(s) or patent application(s) included in RiboGene Patent
Rights, or any extraordinary proceeding relating to such patent(s) or patent
application(s), to Xxxxxx and thereafter RiboGene will fully cooperate with
Xxxxxx in actions which Xxxxxx decides to take with respect to such patent(s) or
patent application(s), and the country in which such patent(s) exists or such
patent application(s) is/are filed shall be thereafter considered a country in
which no Valid Claim exists.
5.2 Program Invention Patent Prosecution and Maintenance According to
the provisions of Article VI of the Research Agreement, Xxxxxx shall have sole
responsibility, employing standards and criteria no
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less rigorous than it employs with respect to the protection of its own
inventions of similar scientific and commercial value, for preparing, in
cooperation with RiboGene's designated patent counsel, filing (domestic and
foreign), prosecuting, issuing, maintaining, defending and enforcing patent
applications and/or patents covering every Program Invention and/or Joint
Program Invention assigned, either solely or jointly, to Xxxxxx or
nonexclusively licensed to Xxxxxx by RiboGene. Xxxxxx shall keep RiboGene fully
aware of the filing and status of and involved with pertinent decisions with
respect to every such patent application and/or patent, shall fully consider
RiboGene's interests and suggestions with respect to the scope and content of
such applications and/or patents, and shall assume all costs associated with all
such patent applications and/or patents in all jurisdictions which it continues
to have an interest.
5.3 Infringement Defense Xxxxxx shall have responsibility, with
RiboGene's cooperation and knowledge, for the defense of any patent infringement
claim, lawsuit or other action brought by any third party against Xxxxxx arising
out of Xxxxxx'x development, testing, manufacture, use, marketing or sale of
Products or Xxxxxx'x Affiliate's and/or sublicensee's marketing or sale of
Products in any country. If RiboGene Intellectual Property is in jeopardy of
being adversely affected by any resolution or settlement of such action,
RiboGene may participate in any such actions at its option and expense.
5.4 Patent Infringement by Third Parties If either party obtains
knowledge that any independent third party is infringing any patent included in
RiboGene Patent Rights, the party obtaining the knowledge shall advise the other
and Xxxxxx and RiboGene shall consult on a reasonable course of action. Xxxxxx
may, but is not obligated to, institute suit to stop such infringement and
RiboGene shall cooperate fully with Xxxxxx and its counsel in the prosecution of
any such suit filed by Xxxxxx. If Xxxxxx decides not to bring suit and so
advises RiboGene of such decision, or if Xxxxxx fails within six (6) months
after notice thereof either to terminate such infringement or to institute suit,
RiboGene may, but is not obligated to, institute suit against the infringing
party. The party bringing the action shall be entitled to retain, from any
recovery which may be obtained therein, its out-of-pocket litigation costs;
Xxxxxx shall then be entitled to recover its lost profits; RiboGene shall then
be
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entitled to recover lost royalties; and the remainder will be divided equally
between the parties. If a suit brought by Xxxxxx must include RiboGene as a
party, RiboGene will permit itself to be joined in such suit and RiboGene will
cooperate fully in the prosecution of any such suit filed by Xxxxxx, at Xxxxxx'x
expense. Each party shall always have the right to be represented by counsel of
its own selection in the protection of RiboGene Patent Rights in any suit
instituted by the other party for infringement, and shall have full access to
all proceedings, documents and information held, developed or obtained in any
such suit.
5.5 Patent Marking Xxxxxx shall xxxx or shall have marked in an
appropriate manner all containers or packages of Products Sold by or for Xxxxxx,
Xxxxxx Affiliate and/or Xxxxxx sublicensee with the appropriate statutory patent
notice for the particular country to indicate that patent coverage has been
obtained or that patents are pending.
5.6 Extensions RiboGene shall, if Xxxxxx cannot legally, apply for and
diligently seek the maximum extension to which it is entitled, of the term of
any patent included in RiboGene Patent Rights under the Drug Price Competition
and Patent Term Restoration Act of 0000, XXX Council Regulation No. 1768/92 and
comparable laws of other jurisdictions. RiboGene shall notify Xxxxxx of its
intent and Xxxxxx shall supply all relevant documents in its possession and
cooperate in all reasonable ways to assist RiboGene in such efforts. RiboGene
shall provide Xxxxxx with copies of its relevant documents related to these
applications.
VI. PRODUCT DEVELOPMENT AND PROMOTION
6.1 Development and Approvals Xxxxxx and/or, if appropriate, any
Affiliate or sublicensee, shall at such entity's own expense, be solely
responsible for the conduct of all appropriate development activities for
Product(s) and the initiation and pursuit of all necessary registrations and
pricing approvals for marketing Product(s).
6.2 Trademarks Xxxxxx is entitled to promote, market and sell
Product(s), or sublicense others, according to the provisions of Article II, to
promote, market and sell Product(s), under trademarks chosen and owned by
Xxxxxx, or its sublicensee, but approved by RiboGene, which
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approval shall not be unreasonably withheld.
6.3 Notification of First Commercial Sale Xxxxxx shall notify RiboGene
at least thirty (30) days prior to each anticipated First Commercial Sale of a
Product in the United States, Great Britain, France, Germany, Italy or Japan.
VII. CONFIDENTIALITY
7.1 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 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 Confidential Information 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 Confidential Information, other than the right to
use such Confidential Information for purposes of this Agreement, shall vest in
the Receiving Party by virtue of disclosure, or the existence of this Agreement.
Should either party use one or more 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.
7.2 Required Disclosure If either party is required by a governmental
regulatory agency or court of competent jurisdiction to disclose either the
other party's Confidential Information, or to disclose other details of this
Agreement or of the Research Agreement, the party subject to such requirement
shall inform the other party as soon as practical of such requirement, shall
reasonably cooperate with the other party in efforts such other party may
decide to take to try to protect its Confidential Information, and shall
release such Confidential Information or other details in response to such
requirement only to the limited extent
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required by such authority.
7.3 Return of Confidential Information Upon expiration of this
Agreement, and the request of the original Disclosing Party, or upon early
termination hereof, the Receiving Party, shall, within one (1) month of such
request or early termination, return or deliver all copies of the Disclosing
Party's Confidential Information, which Confidential Information is then in the
Receiving Party's possession to the Disclosing Party, but the Receiving Party
may retain one (1) complete documentation copy of that Confidential Information
for archival purposes, only to assure compliance with this Agreement, but shall
not thereafter use or disclose any of the Disclosing Party's Confidential
Information or claim any rights thereto.
7.4 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, to the best of its knowledge.
7.5 Publicity Except as permitted under Section 7.6, 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
Agreement 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.
7.6 Permitted Disclosure Abbott may disclose such information related
to this Agreement as is essential to enable Abbott 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.
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VII. WARRANTIES AND LIMITATIONS ON RIGHTS
8.1 RiboGene Warranties RiboGene hereby represents and warrants to
Abbott that, as of the Effective Date: (a) RiboGene has all the requisite
resources power and authority to execute, deliver and perform this Agreement;
(b) 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; (c) RiboGene believes to the best of its
knowledge, that it owns or otherwise has all necessary rights to RiboGene
Intellectual Property in existence as of the Effective Date, and will own or
otherwise have all necessary rights to the other RiboGene Intellectual Property
on which Abbott may reasonably rely during the term of this Agreement; (d) it
has not engaged and shall not engage In any act inconsistent with this
Agreement, particularly that would allow any third party, Including any
government or government agency, to acquire, own or possess any right or.
Interest Inconsistent with Xxxxxx'x rights under this Agreement, except 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; and (e) 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.
8.2 Limitation on Warranties RiboGene makes no representation or
warranty that the RiboGene Compounds identified to Abbott by RiboGene are novel
entities or will not Infringe the patent rights of others.
8.3 Disclaimer Abbott 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 ABBOTT 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
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OR IMPLIED WARRANTIES ARISING FROM THE COURSE OF DEALING, USAGE OR TRADE
PRACTICES, OR OF ANY OTHER KIND.
8.4 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 Confidential
Information or under patents or know-how of the other party except as necessary
to accomplish the purposes of 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.
IX. LIABILITIES AND INDEMNITY
9.1 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 all suits and claims for losses, damage to property,
including environmental, and injury or death to any persons, including employees
of either, arising out of (a) any failure to strictly adhere to safety
instructions, precautions and information provided by the other party and other
generally-recognized safety practices for the storage, handling, use and/or
disposal of any biological, chemical or other materials under or resulting from
this Agreement or the Research Agreement; (b) any use of information or
materials provided under this Agreement, except in reliance on a willful or
grossly negligent misrepresentation or act 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. EXCEPT AS SET FORTH IN SECTION 9.2, 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
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OTHER PARTY, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING OUT OF THIS
AGREEMENT.
9.2 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 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 any 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 Parties 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.
9.3 Abbott Indemnification Abbott shall indemnify, defend and hold
harmless RiboGene, its officers, directors, employees, Affiliates, agents, and
permitted successors and assigns, against any liability, loss or expense
(including reasonable attorneys' fees and expenses of litigation), damage to
property, including environmental, and death or injury to any persons, including
its employees, incurred by or imposed upon any or all of the above in connection
with any claims, suits, actions, demands or judgments arising out of (a)
Xxxxxx'x use of information provided by RiboGene hereunder, or Xxxxxx'x use,
handling, storage or disposal of any Abbott or RiboGene Compound(s) or
Product(s), except in either case, as results from RiboGene's negligence or
intentional misrepresentation or wrongdoing; and/or (b) any theory of product
liability (including, but not limited to, actions in the form of tort, warranty,
or strict liability) concerning any product, process or service discovered or
developed employing results of the Research Program. RiboGene shall, however,
provide Abbott with assistance and/or information, at Xxxxxx'x expense, with
respect to any charge, claim, investigation or proceeding by any third party or
federal, state or local
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governmental authority of competent jurisdiction related to Abbott or RiboGene
Compound(s) or Product(s) or uses thereof according to this Agreement.
X. TERM AND TERMINATION
10.1 Term This Agreement shall be effective upon the date the later
party to sign executes it (which date shall also be entered on page 1 above) and
shall continue in effect through the expiration or termination of Xxxxxx'x
obligations hereunder, unless extended in writing in accordance with the
provisions of Section 10.2. Upon the later of the expiration of the
last-to-expire patent within RiboGene Intellectual Property which contains a
Valid Claim or seventeen and one-half (17.5) years from the Effective Date, the
licenses granted under Sections 2.2 and 2.3 to Xxxxxx and Xxxxxx'x Affiliates
shall be fully paid-up.
10.2 Possible Extension Upon the mutual agreement of the parties, this
License 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.
10.3 Termination Without Breach Prior to the expiration of this License
Agreement, Abbott may terminate it in its entirety without cause upon thirty
(30)-days written notice to RiboGene.
10.4 Effect of Breach In the event of a breach by RiboGene of any
material provision of this Agreement, or default by Abbott of any of Xxxxxx'x
financial obligations to RiboGene or a material breach by Abbott 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 11.7, 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.
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10.5 Effect of Bankruptcy or Agreement Revision Abbott 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 11.9 would so substantially impair the value of the whole
Agreement to that party as to make continuance impractical.
10.6 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.
XI. MISCELLANEOUS
11.1 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 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: President, Pharmaceutical Products Division
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
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11.2 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.
11.3 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, including, except as provided
in Section 2.9, as modified by Section 2.10, of the Research Agreement, from
entering into or continuing any agreement with any third party directed to
screening activities and commercial candidate compound identification.
11.4 No Third-Party Beneficiaries No person or entity not a party to
this Agreement, including any employee of any party to this Agreement, shall
have or acquire any rights by reason of this Agreement, nor shall any party
have any obligations or liabilities to such person or entity by reason of this
Agreement.
11.5 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.
11.6 Merger Clause This Agreement constitutes the complete and entire
understanding between the parties with licenses conveyed hereunder, superseding
and replacing all prior oral or written agreements (except for the accrued
rights and obligations of the Research Agreement of even date, the June 8, 1995
Confidential Disclosure Agreement and the June 7, 1995 Materials Transfer
Agreement between the parties), communications, representations, proposals, or
negotiations specifically
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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 the party against which the provision is
applied.
11.7 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 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 ADA.
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
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than five (5) candidates, believed qualified to
undertake an ADH 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
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.
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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
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
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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.
(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
admissability 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.
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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.
F. 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
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.
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11.8 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.
11.9 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.
11.10 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 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.
11.11 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.
11.12 Government Compliance. RiboGene and Abbott shall comply with all
supranational, 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.
11.13 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
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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
US 08/328,258 10/24/93
(PCT) 94/12,161 10/14/94
