EXECUTION COPY
U.S. COMMERCIALIZATION AGREEMENT
between
GENTA INCORPORATED
and
AVENTIS PHARMACEUTICALS INC.
TABLE OF CONTENTS
Page
(*) Represents language that is redacted and subject to Confidential Treatment.
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U.S. COMMERCIALIZATION AGREEMENT
THIS U.S. COMMERCIALIZATION AGREEMENT (hereinafter, this "AGREEMENT"), made
as of the 26th day of April, 2002 (the "Effective Date"), between GENTA
INCORPORATED, a Delaware corporation having a principal place of business at 0
Xxxxxxx Xxxxx, Xxxxxxxx Xxxxxxx, XX 00000 ("GENTA") and AVENTIS PHARMACEUTICALS
INC., a Delaware corporation having a place of business at 000 Xxxxxxxx
Xxxxxxxxx, Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000 ("AVENTIS") (each referred to
herein as a "Party" or, collectively, the "Parties").
RECITALS
A. GENTA has developed an antisense compound known as G3139 (also known as
oblimerosen sodium) that downregulates the production of Bc1-2 and potentially
other targets.
B. AVENTIS and GENTA desire, among other things, to provide for (a) the
development of products containing or comprising such compound for regulatory
approval in the United States, (b) the commercialization of such products in the
United States, (c) AVENTIS' development of products containing or comprising
such compound for regulatory approval outside of the United States, and (d) the
supply of such products on a global basis, all on the terms and conditions set
forth below.
C. Contemporaneously with this AGREEMENT, GARLISTON LIMITED ("AVENTIS
IRELAND") and GENTA have entered into an Ex-U.S. Commercialization Agreement
(the "Ex-U.S. Commercialization Agreement") under which AVENTIS IRELAND will
commercialize such products outside of the United States, and AVENTIS, AVENTIS
IRELAND and GENTA have entered into a Global Supply Agreement (the "Global
Supply Agreement") under which GENTA will supply AVENTIS and AVENTIS IRELAND
with such products on a global basis.
AGREEMENT
1. DEFINITIONS.
1.1 "AFFILIATE" shall mean any corporation, company, partnership, joint
venture and/or firm which controls, is controlled by, or is under common control
with a specified person or entity. For purposes of this paragraph, "control"
shall be presumed to exist if one of the following conditions is met: (a) in the
case of corporate entities, direct or indirect ownership of at least fifty
percent (50%) of the stock or shares having the right to vote for the election
of directors, and (b) in the case of non-corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the equity interest with the power
to direct the management and policies of such non-corporate entities. The
Parties acknowledge that in the case of certain entities organized under the
laws of certain countries outside of the United States, the maximum percentage
ownership permitted by law for a foreign investor may be less than fifty percent
(50%), and that in such case such lower percentage shall be substituted in the
preceding sentence, provided that such foreign investor has the power to direct
the management and
(*) Represents language that is redacted and subject to Confidential Treatment.
policies of such entity. A "CONTROLLED AFFILIATE" shall mean an entity that is
under the control (as such term is used above) of a Party to this Agreement.
1.2 "ANNUAL NET SALES" shall mean the total NET SALES of PRODUCT for a
particular CALENDAR YEAR.
1.3 "ANNUAL US NET SALES" shall mean the total US NET SALES of PRODUCT for
a particular CALENDAR YEAR.
1.4 (*)
1.5 "AVENTIS HOUSEMARK(S)" shall mean the trade/service xxxx(s), logos,
trade dress, trade names or other symbols or designations exclusively identified
with AVENTIS or an AFFILIATE of AVENTIS, as identified to GENTA in writing.
1.6 "BCL-2" shall mean the species and sequence of the messenger RNA (mRNA)
or the pre-message thereof, encoded by the Bcl lymphoma-2 (Bcl-2) gene, that
generates a Bcl-2 protein, and any and all isoforms thereof.
1.7 "CALENDAR QUARTER" shall mean each three (3) month period of this
AGREEMENT ending on March 31, June 30, September 30 and December 31, except that
the first CALENDAR QUARTER shall be the period from the Effective Date until the
immediately following March 31, June 30, September 30 or December 31, as
applicable, and the last CALENDAR QUARTER shall end upon the expiration or
termination of this AGREEMENT.
1.8 "CALENDAR YEAR" shall mean each twelve (12) month period of this
AGREEMENT ending on December 31, except that the first CALENDAR YEAR shall be
the period from the Effective Date until the immediately following December 31,
and the last CALENDAR YEAR shall end upon the expiration or termination of this
AGREEMENT.
1.9 "CHANGE OF CONTROL" shall mean (a) a merger or consolidation of GENTA
and a SIGNIFICANT PHARMACEUTICAL ENTERPRISE which results in the voting
securities of GENTA outstanding immediately prior thereto ceasing to represent
at least fifty percent (50%) of the combined voting power of the surviving
entity immediately after such merger or consolidation, or (b) a SIGNIFICANT
PHARMACEUTICAL ENTERPRISE, together with its AFFILIATES, becoming the beneficial
owner of fifty percent (50%) or more of the combined voting power of the
outstanding securities of GENTA, or (c) the sale or other transfer of all or
substantially all of GENTA's assets which relate to this AGREEMENT to a
SIGNIFICANT PHARMACEUTICAL ENTERPRISE.
1.10 "CLAIMS" shall mean all charges, complaints, actions, suits,
proceedings, hearings, investigations, claims and demands.
1.11 "CLL" shall mean chronic lymphocytic leukemia.
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.12 "COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to a Party,
the efforts and resources which would be used (including without limitation the
promptness in which such efforts and resources would be applied) by such Party,
consistent with generally-accepted industry standards, with regard to the
diligent development, manufacture and commercialization of pharmaceutical
products of similar market and profit potential at a similar stage in
development or product life. The term "COMMERCIALLY REASONABLE" shall have a
corresponding meaning.
1.13 "COMPOUND" shall mean (i) G3139; and (ii) any OTHER COMPOUND that the
Alliance Management Committee selects for co-development and commercialization
under this AGREEMENT pursuant to Sections 3.1.5 or 4.4.3 below.
1.14 "CPI" shall mean the U.S. Department of Labor's Consumer Price Index
for All Urban Consumers (CPI-U).
1.15 "DATA" shall mean any and all research data, pharmacology data,
chemistry, manufacturing and control data, preclinical data, clinical data
and/or all other documentation submitted, or required to be submitted, to
REGULATORY AUTHORITIES in association with an IND (or other similar foreign
filing) or MAA for PRODUCT (including without limitation any Drug Master Files
(DMFs), Chemistry, Manufacturing and Control (CMC) data, or similar
documentation).
1.16 "DEVELOPMENT COSTS" shall mean the sum of each of the following
incurred after the Effective Date by or on behalf of a Party in fulfilling its
responsibilities under the DEVELOPMENT PLAN as authorized by the Development
Team and approved by the Alliance Management Committee as set forth herein, to
the extent authorized under the applicable DEVELOPMENT PLAN:
1.16.1 all payments made to THIRD PARTIES that are directly related to
the fulfillment of such responsibilities;
1.16.2 the out-of-pocket costs of obtaining COMPOUND or PRODUCT for
use in fulfilling such responsibilities;
1.16.3 the out-of-pocket costs of obtaining any other compound or
product for use in fulfilling such responsibilities; provided, however, that if
such compound or product is obtained from or through AVENTIS, it shall be at
AVENTIS' standard cost for such compound or product;
1.16.4 all internal costs of scientific or technical personnel that
are directly related to the fulfillment of such responsibilities, calculated by
multiplying the number of FTEs utilized for such purpose by the DEVELOPMENT FTE
RATE (which costs shall be tracked in reasonable detail by each Party);
provided, however, that costs associated with representation on, and
participation in, any committee or project team under this AGREEMENT are
excluded from the DEVELOPMENT COSTS; and
1.16.5 any other costs expressly provided for in the DEVELOPMENT PLAN.
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.17 "DEVELOPMENT FTE RATE" shall mean (*) per year per FTE for CALENDAR
YEAR 2002, said amount to be adjusted as of January 1, 2003 and annually
thereafter by the percentage increase or decrease, if any, in the CPI since the
Effective Date or the last adjustment hereunder, whichever is later.
1.18 "DEVELOPMENT PLAN" shall mean the then-current plan and budget for the
research and development of COMPOUND and/or PRODUCT, as such plan and budget is
established and revised in accordance with Section 4.1 below. For avoidance of
doubt, the DEVELOPMENT PLAN shall include, but not be limited to, the following
activities: (a) preclinical and clinical studies, the results of which are
intended for use in obtaining NDA APPROVALS for PRODUCT; (b) development and
documentation of data, methods, processes and procedures for the manufacture
and/or preparation of PRODUCT (including without limitation formulations,
production, sourcing of materials, and development of regulatory methods and
controls); and (c) the preparation and filing of NDAs and all associated
regulatory activities for the United States. Notwithstanding the foregoing, the
DEVELOPMENT PLAN shall not include any research and development activities
directed solely towards obtaining MAA APPROVALS outside the United States.
1.19 "FDA" shall mean the United States Food and Drug Administration and
any successor thereto.
1.20 "FIELD" shall mean all human therapeutic uses.
1.21 "FIRST COMMERCIAL SALE" shall mean the first bona fide commercial sale
of PRODUCT (after FDA approval) to a THIRD PARTY in the United States by or
under authority of AVENTIS, its AFFILIATES or MARKETING DISTRIBUTORS.
1.22 "FIRST-LINE TREATMENT" shall mean (*).
1.23 "FTE" shall mean a full time equivalent employee (i.e., one
fully-committed or multiple partially-committed employees aggregating to one
full-time employee) employed by a Party and assigned to perform specified work,
with such commitment of time and effort to constitute one employee performing
such work on a full-time basis, which for purposes hereof shall be 1,760 hours
per year. In no event does an FTE include a subcontractor.
1.24 "G3139" shall mean that certain all-phosphorothioate oligonucleotide
consisting of 18 modified nucleic acid bases with the sequence and chemical
structure set forth in Exhibit 1.24, which is also known as oblimerosen sodium.
1.25 "GENTA G3139 PATENT RIGHTS" shall mean those PATENT RIGHTS listed in
Exhibit 1.25, (*).
1.26 "GENTA HOUSEMARK(S)" shall mean the trade/service xxxx(s), logos,
trade dress, trade names or other symbols or designations exclusively identified
with GENTA or an AFFILIATE of GENTA, as identified to AVENTIS in writing.
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.27 "GENTA PATENT RIGHTS" shall mean the GENTA G3139 PATENT RIGHTS and any
and all other PATENT RIGHTS owned or controlled by GENTA, or any of its
CONTROLLED AFFILIATES (or, to the extent permissible, (*)) as of the Effective
Date or at any time thereafter during the term of this AGREEMENT, to the extent
that such other PATENT RIGHTS are reasonably necessary to make, have made, sell,
offer for sale, use or import COMPOUND or PRODUCT or, for the purposes of
Section 2.3 only, any OTHER COMPOUND or OTHER PRODUCT as well.
1.28 "GENTA SALES REP FTE RATE" shall mean (*) per FTE for CALENDAR YEAR
2002, said amount to be adjusted as of January 1, 2003 and annually thereafter
by the percentage increase or decrease, if any, in the CPI since the Effective
Date or the last adjustment hereunder, whichever is later.
1.29 "GENTA TECHNOLOGY" shall mean any and all TECHNOLOGY owned or
controlled by GENTA, or any of its CONTROLLED AFFILIATES (or, to the extent
permissible, (*)), as of the Effective Date or at any time thereafter during the
term of this AGREEMENT, to the extent that such TECHNOLOGY is reasonably
necessary to make, have made, sell, offer for sale, use or import COMPOUND or
PRODUCT or, for the purposes of Section 2.3 only, any OTHER COMPOUND or OTHER
PRODUCT as well.
1.30 "GENTA THIRD PARTY AGREEMENTS" shall mean: (*)
1.31 "IND" shall mean an Investigational New Drug application, as defined
in 21 C.F.R. Section 312.3, obtained for purposes of conducting clinical trials
in accordance with the requirements of the United States Federal Food, Drug and
Cosmetic Act and the regulations promulgated thereunder, including all
supplements and amendments thereto.
1.32 "LOSSES" shall mean any and all damages (including all incidental,
consequential, statutory and treble damages), awards, deficiencies, settlement
amounts, defaults, assessments, fines, dues, penalties, costs, fees,
liabilities, obligations, taxes, liens, losses, lost profits and expenses
(including without limitation court costs, interest and reasonable fees of
attorneys, accountants and other experts) awarded or otherwise required to be
paid to THIRD PARTIES with respect to any CLAIM by reason of any judgment,
order, decree, stipulation or injunction, or any settlement entered into in
accordance with the provisions of this AGREEMENT, together with all documented
out-of-pocket costs and expenses paid to THIRD PARTIES and incurred in
connection with defending against or settling such CLAIM (including, without
limitation, reasonable fees of attorneys, accountants and other experts).
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.33 "MAA" or "Marketing Approval Application" shall mean a marketing
authorization application (including or comparable to an NDA), including all
supporting documentation and data submitted for such application to be accepted
for review or approval, filed with the requisite REGULATORY AUTHORITY of any
country of the TERRITORY, and requesting approval for commercialization of
PRODUCT for a particular indication in such country.
1.34 "MAA APPROVAL" shall mean, with respect to a particular country in the
TERRITORY, approval by the applicable REGULATORY AUTHORITIES in such country of
an MAA filed in such country, permitting PRODUCT to be marketed in that country
for the indication(s) for which approval is sought, including, if applicable,
approval of pricing or reimbursement.
1.35 "MAJOR COUNTRY" shall mean (*).
1.36 "MAJOR EUROPEAN COUNTRY" shall mean: (*).
1.37 "MAJOR INDICATION" shall mean (*):
a) (*),
b) (*).
1.38 "MARKETING DISTRIBUTOR" shall mean a THIRD PARTY to whom AVENTIS or
its AFFILIATE has granted a right to distribute, market, sell and/ or promote
PRODUCT.
1.39 "NDA" shall mean a new drug application, to permit commercial
marketing of a product in the United States, pursuant to section 505 of the
United States Federal Food, Drug and Cosmetic Act, and the regulations
promulgated thereunder, as amended from time to time, as submitted to the FDA,
including all amendments, supplements and successor applications, and shall also
mean any biological license application (BLA), to permit commercial marketing
pursuant to the United States Public Health Service Act.
1.40 "NDA APPROVAL" shall mean approval by the FDA of an NDA.
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.41 "NET SALES" shall mean the gross invoiced sales of PRODUCT by AVENTIS,
its AFFILIATES and their MARKETING DISTRIBUTORS to THIRD PARTIES, after
deducting: (a) trade, cash and/or quantity discounts not already reflected in
the amount invoiced; (b) excise, sales and other consumption taxes and custom
duties to the extent included in the invoice price; (c) freight, insurance and
other transportation charges to the extent included in the invoice price; (d)
amounts repaid or credited by reason of rejections, defects, recalls or returns
or because of chargebacks, retroactive price reductions, refunds or billing
errors, and (e) compulsory payments and rebates directly related to the sale of
PRODUCT, accrued, paid or deducted pursuant to agreements (including, but not
limited to, managed care agreements) or governmental regulations. Sales between
AVENTIS and its AFFILIATES and their MARKETING DISTRIBUTORS for resale shall be
excluded from the computation of NET SALES, provided that the subsequent resale
is included within NET SALES. If PRODUCT is sold, transferred or otherwise
disposed of for consideration other than exclusively cash or other than at arm's
length, then the NET SALES from such sale, transfer or other disposition shall
be the arm's length fair market value thereof.
1.42 (*).
1.43 "OTHER COMPOUND" shall mean (*).
1.44 "OTHER PRODUCT" shall mean any pharmaceutical composition containing
OTHER COMPOUND (i.e., OTHER COMPOUND alone or as incorporated into any
formulation or delivery system) other than the PRODUCT.
1.45 "PATENT RIGHTS" shall mean any patents, patent applications,
certificates of invention, or applications for certificates of invention and any
supplemental protection certificates, together with any extensions,
registrations, confirmations, reissues, divisions, continuations or
continuations-in-part, reexaminations or renewals thereof, that may be sought
throughout the world.
1.46 "PRODUCT" shall mean any pharmaceutical composition containing
COMPOUND (i.e., COMPOUND alone or as incorporated into any formulation or
delivery system).
1.47 "PRODUCT TRADEMARK" shall mean the trademark identified in Exhibit
1.47 attached hereto, or such other trademark, symbol, logo and/or trade dress
as the U.S. Commercialization Team shall adopt for the PRODUCT in the United
States.
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.48 "REGULATORY AUTHORITY" shall mean the FDA or any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of any
federal, state, county, city or other political subdivision, domestic or
foreign, that performs a function for such political subdivision similar to the
function performed by the FDA for the United States with regard to the approval,
licensing, registration or authorization to test, manufacture, promote, market,
distribute, use, store, import, transport or sell a product in the defined
territory or political subdivisions, or with respect to the approval of pricing
or reimbursement for such product.
1.49 "ROW" shall mean the entire TERRITORY other than the United States.
1.50 "SIGNIFICANT PHARMACEUTICAL ENTERPRISE" shall mean (a) a company
(other than AVENTIS or its AFFILIATES) which, together with its AFFILIATES, had
worldwide annual revenues from the sale of pharmaceutical products in excess of
$5.0 billion during its most recently completed fiscal year and (b) any
AFFILIATES of such company.
1.51 "TECHNOLOGY" shall mean unpatented proprietary technical information
including, but without prejudice to the generality of the foregoing, ideas,
concepts, inventions, discoveries, assays, cell lines, enzymes and other
biological materials, specifications, procedures for experiments and tests and
other protocols, results of experimentation and testing, production and
purification techniques and processes and assay protocols, screens, models,
software, practices, methods, know-how and test data including pharmacological,
toxicological and clinical test data and analytical and quality control data.
1.52 "TERRITORY" shall mean all countries of the world.
1.53 "THIRD PARTY(IES)" shall mean any party other than AVENTIS, GENTA and
their AFFILIATES.
1.54 "US NET SALES" shall mean NET SALES of PRODUCT in the United States.
1.55 "VALID CLAIM" shall mean a claim (a) of any issued, unexpired patent
which has not been revoked or held unenforceable or invalid by a decision of a
court or governmental agency of competent jurisdiction from which no appeal can
be taken, or with respect to which an appeal is not taken within the time
allowed for appeal, and which has not been disclaimed, denied or admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise, or (b) of any
patent application which shall not have been cancelled, withdrawn, abandoned nor
been pending for more than five (5) years from the earliest priority date
claimed for such application.
2. GRANT OF RIGHTS; NON-COMPETE.
2.1 Exclusive Grant to Commercialize. In consideration of the commitments
and undertakings of AVENTIS under this AGREEMENT, GENTA hereby grants to AVENTIS
an exclusive right and license to practice under the GENTA PATENT RIGHTS, and to
use, reproduce, modify and otherwise exploit the GENTA TECHNOLOGY, in each case
only to sell, offer for sale and import COMPOUND and PRODUCT into and throughout
the United States for use in the FIELD. Such grant shall be exclusive even as to
GENTA and its AFFILIATES; provided, however, that GENTA and its AFFILIATES shall
retain such rights as are reasonably
(*) Represents language that is redacted and subject to Confidential Treatment.
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necessary for them to exercise their rights and perform their obligations as
expressly set forth in this AGREEMENT, the Ex-U.S. Commercialization Agreement
and the Global Supply Agreement. AVENTIS may exercise such license rights
through its AFFILIATES and through its or their MARKETING DISTRIBUTORS who
distribute other AVENTIS products; provided, however, AVENTIS and its AFFILIATES
must obtain GENTA's prior written approval before exercising such rights through
a MARKETING DISTRIBUTOR who is responsible for all or substantially all of the
marketing and promotion of the PRODUCT within the United States, provided
further, however, that no such approval is required if AVENTIS has a thirty
percent (30%) or greater equity interest in such MARKETING DISTRIBUTOR. For
clarification purposes, AVENTIS shall not be required to seek GENTA's prior
written approval to use normal wholesale or specialty distribution channels.
2.2 Exclusive Grant to Manufacture. In consideration of the commitments and
undertakings of AVENTIS under this AGREEMENT, GENTA hereby grants to AVENTIS an
exclusive right and license to practice under the GENTA PATENT RIGHTS, and to
use, reproduce, modify and otherwise exploit the GENTA TECHNOLOGY, in each case
only to make and use COMPOUND and PRODUCT in the FIELD. Such grant shall be
exclusive even as to GENTA and its AFFILIATES; provided, however, that GENTA and
its AFFILIATES shall retain such rights as are reasonably necessary for them to
exercise their rights and perform their obligations as expressly set forth in
this AGREEMENT, the Ex-U.S. Commercialization Agreement and the Global Supply
Agreement. AVENTIS may exercise such license rights through its AFFILIATES.
2.3 Grant to Conduct Research and Development. In consideration of the
commitments and undertakings of AVENTIS under this AGREEMENT, GENTA hereby
grants to AVENTIS a co-exclusive right and license, along with GENTA and its
AFFILIATES, to practice under the GENTA PATENT RIGHTS, and to use, reproduce,
modify and otherwise exploit the GENTA TECHNOLOGY, in each case only to make
(but not have made), use and import (but not sell or offer for sale) OTHER
COMPOUNDS and OTHER PRODUCTS solely for research and development purposes.
AVENTIS may exercise such license rights through its AFFILIATES.
2.4 Conflict with Certain Existing Agreements.
2.4.1 To the extent that GENTA is not authorized under one or more of
the GENTA THIRD PARTY AGREEMENTS to grant AVENTIS any of the license rights set
forth in Section 2.2 or Section 2.3 above, but GENTA would be authorized under
the GENTA THIRD PARTY AGREEMENTS to grant such license rights to an entity owned
equally by AVENTIS and GENTA, the grants under such sections shall not be
effective; provided, however, that the Parties shall, upon AVENTIS' written
request, promptly execute or cause to be executed such written agreements as are
necessary to establish and grant said license rights to such entity on terms and
conditions otherwise consistent with the provisions of this AGREEMENT, the
Ex-U.S. Commercialization Agreement and the Global Supply Agreement, which terms
and conditions shall not require the payment to GENTA of any additional fees or
other amounts.
2.4.2 Notwithstanding anything to the contrary in this AGREEMENT, the
rights and licenses granted by GENTA to AVENTIS (and its AFFILIATES and
MARKETING
(*) Represents language that is redacted and subject to Confidential Treatment.
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DISTRIBUTORS) hereunder, and under the Global Supply Agreement are subject to
the terms, conditions and provisions of the GENTA THIRD PARTY AGREEMENTS
applicable thereto, such that AVENTIS (and its AFFILIATES and MARKETING
DISTRIBUTORS) shall be subject to any restrictions or limitations on the rights
granted to GENTA under the GENTA THIRD PARTY AGREEMENTS and any other
obligations set forth in writing in such GENTA THIRD PARTY AGREEMENTS expressly
applicable to sublicensees or sub-sublicensees (other than payment obligations).
2.4.3 Nothing in this Section 2.4 shall limit either Party's rights or
remedies on account of any breach by such Party of its representations,
warranties, covenants or agreements under Section 17.1 or Section 17.2 below.
2.5 Non-Compete.
2.5.1 Manufacturing. Other than as expressly authorized under this
AGREEMENT, the Ex-U.S. Commercialization Agreement and/or the Global Supply
Agreement, neither GENTA, nor its AFFILIATES, shall make COMPOUND or PRODUCT for
or on behalf of, or authorize or permit another to make COMPOUND or PRODUCT for
or on behalf of, any person or entity other than AVENTIS and AVENTIS IRELAND
during the term of this AGREEMENT.
2.5.2 Development and Commercialization. (*).
(*) Represents language that is redacted and subject to Confidential Treatment.
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2.6 No Implied Licenses. All rights not granted herein are reserved.
Nothing in this AGREEMENT shall be deemed to constitute the grant of any license
or other right to either Party, to or in respect of any product, patent,
trademark, Confidential Information, trade secret or other data or any other
intellectual property of the other Party, except as expressly set forth herein.
Without limiting the foregoing, no licenses are granted by GENTA to AVENTIS
other than with respect to COMPOUND, PRODUCT, OTHER COMPOUND and OTHER PRODUCT.
3. GOVERNANCE.
3.1 The Alliance Management Committee. AVENTIS and GENTA shall establish an
alliance management committee (the "Alliance Management Committee") promptly
following the Effective Date. The Alliance Management Committee shall have as
its overall purpose the oversight, review and coordination of the development of
PRODUCT for registration in the United States, the commercialization of PRODUCT
in the United States, and the supply of PRODUCT on a global basis, subject to
the provisions of this Section 3.
3.1.1 Membership. The Alliance Management Committee shall be comprised
of representatives from each of AVENTIS and GENTA, selected by such Party. The
exact number of representatives of each Party shall be as determined by such
Party. GENTA and AVENTIS each may replace its Alliance Management Committee
representatives at any time, subject to the foregoing, with prior written notice
to the other Party.
3.1.2 Alliance Management Committee Meetings. The Alliance Management
Committee shall meet at such times and places as are required by the Alliance
Management Committee to perform its responsibilities as set forth herein, but in
no event less than once each CALENDAR QUARTER.
3.1.3 (*).
(a) (*)
(b) (*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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(*)
3.1.4 Duties. The Alliance Management Committee shall:
(a) review and approve the DEVELOPMENT PLAN and changes thereto
as submitted by the Development Team;
(b) review and approve the supply plan and changes thereto as
submitted by the Supply Chain Team; and
(c) make those other specific decisions expressly designated to
be made by the Alliance Management Committee under this AGREEMENT.
3.1.5 Addition of Compounds. At any time after the Effective Date,
either Party may make a written proposal to the Alliance Management Committee
respecting the addition of any OTHER COMPOUND to the definition of COMPOUND set
forth herein. Such proposal shall include, to the extent reasonably available,
(i) any data and other information in such Party's possession which may be
relevant to the development, manufacture or commercialization of such OTHER
COMPOUND, (ii) a reasonably detailed outline of the major research and
development activities required to obtain MAA APPROVALS for products containing
or comprising such OTHER COMPOUND, including a timeline for the performance of
such activities, (iii) an estimated budget for the development costs associated
with such activities, (iv) a summary of any intellectual property rights
relevant to such OTHER COMPOUND, and (v) a market analysis of such OTHER
COMPOUND, including market size, competitor analysis, etc. If the Alliance
Management Committee elects to add such OTHER COMPOUND to the definition of
COMPOUND, it shall issue a written statement to the Parties to such effect,
whereupon such OTHER COMPOUND shall become a COMPOUND for purposes of this
AGREEMENT. Thereupon, the Alliance Management Committee shall instruct the
Development Team to revise the DEVELOPMENT PLAN to incorporate development
activities associated with such OTHER COMPOUND.
3.2 Joint Teams. To further the goals of this AGREEMENT, the Parties shall
promptly draw upon the necessary personnel and experts from each Party to create
certain joint teams ("Teams") as follows:
3.2.1 The Development Team. The Development Team shall have as its
overall purpose the development, implementation and management of development
activities necessary to obtain NDA APPROVALS for PRODUCT.
(a) Membership. The Development Team shall be comprised of
representatives from each of AVENTIS and GENTA, selected by such Party. The
exact number of representatives of each Party shall be as determined by such
Party. GENTA and AVENTIS may each replace its Development Team members at any
time, subject to the foregoing, with prior written notice to the other Party.
(*) Represents language that is redacted and subject to Confidential Treatment.
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(b) Development Team Meetings. The Development Team shall meet at
such times and places as are required by the Development Team to perform its
responsibilities as set forth herein, but in no event less than once each
CALENDAR QUARTER.
(c) (*).
(d) Duties. The Development Team shall:
1. prepare and present a proposed DEVELOPMENT PLAN to the
Alliance Management Committee for approval on an annual basis;
2. review the DEVELOPMENT PLAN as needed, but no less
frequently than once each CALENDAR QUARTER;
3. propose and present revisions to the DEVELOPMENT PLAN to
the Alliance Management Committee for approval as necessary; and
4. subject to, and within the constraints of the
then-current DEVELOPMENT PLAN:
(A) oversee the implementation of the DEVELOPMENT PLAN, allocate
responsibilities to each Party in connection with executing the DEVELOPMENT
PLAN, and reviewing each Party's execution of its responsibilities under the
DEVELOPMENT PLAN;
(B) review the rate of spending on development activities against the
budget for such activities in the DEVELOPMENT PLAN;
(C) review and approve the filing of any INDs for PRODUCT and the
submission of protocols for such INDs;
(D) review and approve the filing of any NDAs for PRODUCT;
(E) present the results of development efforts to the Alliance
Management Committee as needed, but no less often than once each CALENDAR
QUARTER;
(F) formulate a life-cycle management strategy for PRODUCT in concert
with the U.S. Commercialization Team, evaluate opportunities for new
formulations, delivery systems and improvements with respect to PRODUCT in
concert with the U.S. Commercialization Team and, where appropriate, recommend
pursuit of such opportunities to the Alliance Management Committee.
(G) perform such activities as are delegated to the Development Team
in Section 4 below; and
(*) Represents language that is redacted and subject to Confidential Treatment.
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(H) perform any such other duties delegated to the Development Team by
the Alliance Management Committee.
3.2.2 The U.S. Commercialization Team.
(a) U.S. Commercialization Team. The U.S. Commercialization Team
shall have as its overall purpose the development and implementation of
commercial activities for PRODUCT in the United States. The U.S.
Commercialization Team shall be comprised of representatives from each of
AVENTIS and GENTA, selected by such Party. The exact number of representatives
of each Party shall be as determined by such Party. GENTA and AVENTIS may each
replace its members at any time, subject to the foregoing, with prior written
notice to the other Party.
(b) Meetings. The U.S. Commercialization Team shall meet at such
times and places as are required by the U.S. Commercialization Team to perform
its responsibilities as set forth herein, but in no event less than once each
CALENDAR QUARTER.
(c) (*).
(d) Duties. The U.S. Commercialization Team shall:
(A) develop and discuss strategies for the promotion and marketing of
PRODUCT in the United States, including allocation of responsibility for
marketing and commercialization activities;
(B) decide whether to perform all clinical trials for the U.S. market
that are not intended for use in obtaining NDA APPROVALS for PRODUCT, and to
control all such clinical trials;
(C) determine the launch dates for PRODUCT;
(D) determine the price for PRODUCT and any and all ranges of
discounts;
(E) prepare short term and long term sales forecasts;
(F) present sales forecasts and the results of all U.S.
commercialization efforts to the Alliance Management Committee as needed, but no
less often than once each CALENDAR QUARTER;
(*) Represents language that is redacted and subject to Confidential Treatment.
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(G) formulate a life-cycle management strategy for PRODUCT in concert
with the Development Team, evaluate opportunities for new formulations, delivery
systems and improvements with respect to PRODUCT in concert with the Development
Team and, where appropriate, recommend pursuit of such opportunities to the
Alliance Management Committee;
(H) oversee all recalls, market withdrawals and any other corrective
actions related to PRODUCT in the United States; and
(I) perform such activities as are delegated to the U.S.
Commercialization Team in Section 7 below.
3.2.3 The Supply Chain Team.
(a) Supply Chain Team. The Supply Chain Team shall have as its
overall purpose the management of supply of PRODUCT and COMPOUND to AVENTIS
pursuant to the Global Supply Agreement. The Supply Chain Team shall be
comprised of representatives from each of AVENTIS and GENTA, selected by such
Party. The exact number of representatives of each Party shall be as determined
by such Party. GENTA and AVENTIS may each replace its members at any time,
subject to the foregoing, with prior written notice to the other Party.
(b) Meetings. The Supply Chain Team shall meet at such times and
places as are required by the Supply Chain Team to perform its responsibilities
as set forth herein, but in no event less than once each CALENDAR QUARTER.
(c) (*).
(d) Duties. The Supply Chain Team shall:
(A) prepare a supply plan coordinating the entire supply chain to
support all PRODUCT needs and prepare associated regulatory strategy and
procedures;
(B) propose and accept new product suppliers for COMPOUND and PRODUCT,
subject to AVENTIS' right to assume certain manufacturing responsibilities,
without consent of the Supply Chain Team, as set forth in the Global Supply
Agreement;
(C) oversee all manufacturing of COMPOUND and PRODUCT, and all
packaging and labeling of PRODUCT;
(D) identify and propose actions to prevent potential interruptions of
COMPOUND or PRODUCT supply;
(E) perform capacity analysis and oversee audits of any suppliers;
(*) Represents language that is redacted and subject to Confidential Treatment.
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(F) plan and oversee the quality control and assurance, implementation
process improvements, cost reduction initiatives, logistics initiatives, and
environmental, health and safety initiatives; and
(G) perform any such other duties delegated to the Supply Chain Team
by the Alliance Management Committee.
Notwithstanding anything to the contrary herein, all activities conducted by the
Supply Chain Team shall be consistent with and subject to the provisions of the
Global Supply Agreement.
3.3 Scope of Governance. It is understood the Alliance Management Committee
and the Teams shall abide by, and shall not have the authority to contravene or
amend, any of the terms or conditions set forth in this AGREEMENT or any of the
Parties' express rights hereunder.
4. DEVELOPMENT PROGRAM.
4.1 The Development Plan.
4.1.1 Establishment of the Development Plan. Within one hundred eighty
(180) days following the Effective Date, the Development Team shall prepare and
present to the Alliance Management Committee for its review and approval a
proposed DEVELOPMENT PLAN for the remainder of the current CALENDAR YEAR and for
the two (2) subsequent CALENDAR YEARS. Thereafter, on an annual basis,
consistent with each Party's normal timelines for the budget planning process
but in no event later than November 1 of each year, the Development Team shall
prepare and present to the Alliance Management Committee for its review and
approval a proposed DEVELOPMENT PLAN for the next CALENDAR YEAR and for the two
(2) subsequent CALENDAR YEARS. Each proposed DEVELOPMENT PLAN shall consist of
(a) a reasonably detailed plan and budget for the first CALENDAR YEAR covered by
such plan, and (b) a preliminary assessment of the development activities to be
performed during the two (2) subsequent CALENDAR YEARS covered by such plan.
Upon approval of the Alliance Management Committee in accordance with Section
3.1 above, the proposed DEVELOPMENT PLAN, with such changes as the Alliance
Management Committee may establish, shall become the DEVELOPMENT PLAN for the
relevant period. If such a plan and budget is not established by January 1 of a
CALENDAR YEAR, then, until it is established, the Parties shall continue to fund
(pursuant to Section 4.4) those ongoing trials that were started under a
previously approved DEVELOPMENT PLAN in accordance with the terms thereof.
4.1.2 Changes to the Development Plan. The Development Team shall
review the DEVELOPMENT PLAN on an ongoing basis, and may propose revisions
thereto to the Alliance Management Committee; provided, however, the DEVELOPMENT
PLAN in effect for a year shall not be materially modified (which shall include
any change to the budget for activities to be conducted under the DEVELOPMENT
PLAN) except as approved by the Alliance Management Committee.
4.1.3 Preliminary Development Activities. Exhibit 4.1.3 attached
hereto sets forth certain minimum activities that shall be included in the
initial DEVELOPMENT PLAN.
(*) Represents language that is redacted and subject to Confidential Treatment.
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4.1.4 Payment of Certain Clinical Drug Supply. (*) agrees to pay for
the cost of clinical drug supply of PRODUCT incurred after the Effective Date
for those (*) trials and/or (*) studies listed on Exhibit 4.1.4.
4.2 Activities. The Development Team shall be responsible for authorizing
the initiation of all clinical trials under the DEVELOPMENT PLAN. Subject to
receiving such authorization, each Party shall use COMMERCIALLY REASONABLE
EFFORTS to perform those responsibilities allocated to such Party under the
DEVELOPMENT PLAN with respect to such activity within the timeframes specified
in the DEVELOPMENT PLAN for performance of such activity.
4.3 Performance. Except as set forth in Section 4.5 or Section 7 below,
neither Party shall have the right to perform any developmental activities with
respect to COMPOUND or PRODUCT (including, without limitation, the initiation of
any clinical trials intended for use in obtaining NDA APPROVALS for PRODUCT)
except as: (i) specifically set forth in, and as specifically allocated to such
Party in, the DEVELOPMENT PLAN, or (ii) specifically and unanimously agreed to
by the Development Team or the Alliance Management Committee.
4.4 Cost Allocation. Subject to the limitations set forth below, AVENTIS
shall be responsible for seventy-five percent (75%) of the total DEVELOPMENT
COSTS incurred by GENTA and AVENTIS in accordance with the DEVELOPMENT PLAN (the
"AVENTIS Share"), and GENTA shall be responsible for the remaining twenty-five
percent (25%) (the "GENTA Share"); each referred to herein as each Party's
"Percentage Share." AVENTIS shall bear one hundred percent (100%) of all costs
incurred by AVENTIS (or, if agreed upon by the Parties in the DEVELOPMENT PLAN,
incurred by GENTA) in connection with any clinical trials or other development
activities not intended for use in obtaining NDA APPROVALS for PRODUCT, to the
extent such trials or activities are not included in the DEVELOPMENT PLAN.
4.4.1 Balancing and Reconciling Payments. Within fifteen (15) days
following the end of each CALENDAR QUARTER during the term of this AGREEMENT,
each Party shall provide to the other a preliminary report reasonably detailing
in summary fashion such Party's good faith estimate of the DEVELOPMENT COSTS
incurred by such Party during such CALENDAR QUARTER. Within forty (40) days
following the end of each CALENDAR QUARTER, each Party shall provide to the
other a final report reasonably detailing in summary fashion the DEVELOPMENT
COSTS incurred by such Party during such CALENDAR QUARTER, in a form reasonably
agreed by the Parties, including a reasonably detailed accounting supporting the
costs included in the DEVELOPMENT COSTS (a "Development Cost Summary"). Payment
in order to reconcile each Party's responsibility for such costs shall be made
in accordance with the provisions of Section 11.3 below.
4.4.2 Excess Costs. No less often than once each CALENDAR QUARTER, the
Development Team shall review the actual and expected DEVELOPMENT COSTS against
the budget for such costs for the current CALENDAR YEAR. Should the Development
Team determine, or should either Party otherwise have reason to believe
(whereupon such Party shall
(*) Represents language that is redacted and subject to Confidential Treatment.
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provide the other Party with prompt written notice thereof), that the total
DEVELOPMENT COSTS for the current CALENDAR YEAR are likely to exceed the
DEVELOPMENT COSTS budgeted for such CALENDAR YEAR in the DEVELOPMENT PLAN then
in effect, the Development Team shall promptly meet (in person, via
teleconference or in some other agreeable manner) to discuss the situation and,
if appropriate, recommend to the Alliance Management Committee revisions to the
DEVELOPMENT PLAN so that the expected DEVELOPMENT COSTS are no longer in excess
of the budget for the DEVELOPMENT PLAN. If the Development Team cannot agree
that authorization of the cost overrun is justified, it shall take steps to
remedy the situation.
4.43 (*):
(a) (*);
(*) Represents language that is redacted and subject to Confidential Treatment.
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(b) (*);
(c) (*); :
(i) (*)
(ii) (*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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(*)
4.5 Ex-U.S. Development. AVENTIS shall be responsible for conducting and
supporting all clinical trials and other development activities intended for use
solely in obtaining MAA APPROVALS for PRODUCT outside of the United States. To
the extent provided to its senior management committee (and within a reasonable
time after such committee's receipt), AVENTIS shall give GENTA the opportunity
to review and to make recommendations concerning such clinical trials and other
development activities throughout the world reasonably in advance of commencing
such trials and activities. In that regard, no less frequently than once each
CALENDAR QUARTER, AVENTIS shall provide to the Alliance Management Committee a
list of all centrally-coordinated clinical trials being conducted by AVENTIS
that are not included in the DEVELOPMENT PLAN.
5. REGULATORY MATTERS.
5.1 Regulatory Approvals.
5.1.1 Development Team Participation. Each Party shall consult with
and solicit the active participation of the Development Team before proceeding
with any NDA filings, meetings and/or telephone conferences with the FDA that
pertain to PRODUCT, and shall keep the Development Team fully apprised of and
involved in all regulatory activities involving PRODUCT, including the status of
such activities. The Development Team shall oversee the inclusion of all
clinical and preclinical studies within NDAs for PRODUCT.
5.1.2 United States. As between the Parties, GENTA (and/or its
AFFILIATES or vendors) shall be responsible for filing, obtaining approval of
and maintaining all INDs, Drug Master Files (DMFs), BLAs and NDAs, as well as
all amendments and supplements thereto, for PRODUCT in the United States, and
thereafter for holding and maintaining all NDA APPROVALS, other approvals and
authorizations for PRODUCT (including, without limitation, for any labels,
labeling, package inserts and packaging) and for any promotional materials
relating to PRODUCT in the United States in its own name; provided, however,
that GENTA shall not make any submissions (including, without limitation, any
NDAs) to, or otherwise communicate or correspond with, the FDA with respect to
PRODUCT or COMPOUND without the approval of the Development Team. GENTA shall be
solely responsible for submitting all information and filing all reports to
seek, obtain and maintain any NDA APPROVALS granted for PRODUCT, and shall
comply with all requirements of the United States Federal Food, Drug and
Cosmetic Act, and FDA's regulations thereunder, as related to PRODUCT,
including, without limitation, reporting of adverse drug experiences. GENTA
shall provide AVENTIS with reasonable advance written notice of any filings,
submissions, meetings, telephone conferences and/or other discussions with the
FDA, scheduled or unscheduled, that pertain to PRODUCT or COMPOUND, and,
consistent with applicable laws, shall afford AVENTIS' representatives an
opportunity to actively participate in the drafting and review of such filings
and submissions, and
(*) Represents language that is redacted and subject to Confidential Treatment.
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to attend and actively participate in all such meetings, telephone conferences
and/or discussions with the FDA, and shall provide AVENTIS with copies of all
such filings and submissions and of any minutes of any such meetings, telephone
conferences and/or discussions. In addition, GENTA shall provide AVENTIS with
all information, data and materials reasonably necessary for AVENTIS to
undertake such activities, said items to be provided to AVENTIS at least seven
(7) days in advance of the date on which the applicable activity is expected to
occur. To the extent feasible, GENTA shall adopt all reasonable suggestions and
recommendations of AVENTIS concerning any filings or other submissions to the
FDA. Any THIRD PARTY contractor utilized by GENTA to compile any regulatory
documentation pertaining to PRODUCT shall be subject to AVENTIS' prior written
approval, such approval not to be unreasonably withheld. GENTA shall promptly
notify AVENTIS with respect to any material changes or material problems that
may arise in connection with its MAA APPROVALS in the United States. For
clarification purposes, the filing and maintenance fees associated with the
above regulatory activities shall be deemed part of the DEVELOPMENT COSTS.
5.1.3 International. As between the Parties, AVENTIS (and/or its
AFFILIATES or vendors) shall be responsible for filing all XXXx for PRODUCT in
countries of the ROW, and thereafter for holding and maintaining all MAA
APPROVALS, other approvals and authorizations for PRODUCT (including, without
limitation, for any labels, labeling, package inserts and packaging) and for any
promotional materials relating to PRODUCT in countries of the ROW in its own
name. AVENTIS shall be solely responsible for filing all reports required to be
filed in order to maintain any MAA APPROVALS granted for PRODUCT in the ROW,
including, without limitation, reporting of adverse drug experiences. AVENTIS
shall promptly notify GENTA with respect to any material changes or material
problems that may arise in connection with its MAA APPROVALS in such countries.
AVENTIS shall also be responsible for obtaining any export approvals required to
export PRODUCT to other countries of the TERRITORY.
5.1.4 Conduct of Development Activities. In conducting any development
activities with respect to COMPOUND or PRODUCT under the DEVELOPMENT PLAN, each
Party shall:
(a) ensure that its employees, agents, clinical institutions and
clinical investigators comply with all FDA statutory and regulatory requirements
with respect to COMPOUND and PRODUCT, including, but not limited to: the Federal
Food, Drug and Cosmetic Act, as amended (FFDCA); the Public Health Service Act
(PHSA); regulatory provisions regarding protection of human subjects, financial
disclosure by clinical investigators, Institutional Review Boards (IRB), and
Good Laboratory Practice provisions set forth in 21 C.F.R. Section 50-56; IND
requirements in 21 C.F.R. Section 312; the IND for COMPOUND or PRODUCT; the
Investigational Plan; and any conditions imposed by a reviewing IRB or the FDA;
and
(b) not utilize, in conducting studies on COMPOUND or PRODUCT,
any persons or entities that at such time are debarred by FDA, or that, at such
time, are under investigation by FDA for debarment action pursuant to the
provisions of the Generic Drug Enforcement Act of 1992 (21 U.S.C. Section 335a).
(*) Represents language that is redacted and subject to Confidential Treatment.
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5.1.5 Sharing of Regulatory Filings. Each Party shall permit the other
Party to access, and shall provide the other Party with sufficient rights to
reference and use in association with exercising its rights and performing its
obligations under this AGREEMENT, the Ex-U.S. Commercialization Agreement and
the Global Supply Agreement, all of its, its AFFILIATES' and their respective
suppliers' DATA, regulatory filings and regulatory communications associated
with any submissions for MAA APPROVALS or other approvals for COMPOUND and/or
PRODUCT.
5.2 Exchange of Data. Upon request of the Development Team, the Parties
shall provide to the Development Team all DATA generated or obtained in the
course of the performance of activities under the DEVELOPMENT PLAN in a prompt
manner. Each Party shall bear its own costs associated with the transfer or
exchange of DATA to the Development Team.
5.3 Adverse Experiences. With respect to adverse drug experiences, as
defined by 21 C.F.R. Section 314.80, and IND safety reports, as referenced in 21
C.F.R. Section 312.32, relating to PRODUCT, the Development Team shall establish
operating procedures to report to the appropriate REGULATORY AUTHORITIES in the
countries in which PRODUCT is being developed or commercialized, in accordance
with the appropriate laws and regulations of the relevant countries and
authorities. Such operating procedures shall include any measures necessary for
each Party to fully comply with such laws and regulations as apply to such
Party. The Parties will collaborate to agree to and implement, within ninety
(90) days following the Effective Date, a separate agreement concerning
Pharmacovigilance responsibilities and case exchange.
5.4 Regulatory Cooperation. Each Party shall inform the Development Team,
within forty-eight (48) hours, of its receipt of any information that: (a)
raises any material concern regarding the safety or efficacy, or manufacturing,
of COMPOUND or PRODUCT; (b) raises any material concern regarding FDA's or any
REGULATORY AUTHORITY's acceptance of any data or information submitted with
respect to COMPOUND or PRODUCT, requests any additional data or information with
respect to COMPOUND or PRODUCT, or suggests that requests for additional data or
information may be forthcoming, or that NDA APPROVALS or MAA APPROVALS will not
be issued; (c) indicates or suggests a potential material liability for either
Party to a THIRD PARTY arising in connection with COMPOUND or PRODUCT; (d)
concerns suspected or actual PRODUCT tampering or contamination or other
material problems with respect to COMPOUND or PRODUCT, (e) is reasonably likely
to lead to a recall or market withdrawal of PRODUCT; or (f) concerns any ongoing
or potential FDA or other REGULATORY AUTHORITY investigation, inspection,
detention, seizure or injunction involving COMPOUND or PRODUCT, including,
without limitation, the receipt of any warning letter or untitled letter
relating to COMPOUND or PRODUCT.
5.5 Recalls and Other Corrective Actions.
5.5.1 United States. The U.S. Commercialization Team shall make all
final decisions with respect to any recall, market withdrawal or any other
corrective action related to PRODUCT in the United States, and neither Party
shall initiate any such action without the approval of the U.S.
Commercialization Team; provided, however, that nothing herein shall
(*) Represents language that is redacted and subject to Confidential Treatment.
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prohibit GENTA, as the NDA APPROVAL holder, from initiating or conducting any
recall or other corrective action mandated by the FDA or applicable U.S. law,
although before taking any such mandated action, GENTA shall provide AVENTIS
with a reasonable opportunity to review, comment on and consult with GENTA with
respect thereto and shall consider in good faith any comments or suggestions of
AVENTIS. Subject to the foregoing sentence, GENTA shall be responsible for
conducting any recall, market withdrawals, or other corrective action related to
PRODUCT in the United States, and GENTA shall undertake such actions in a manner
designed to minimize any harm to the marketability of PRODUCT or the reputation
of the Parties. AVENTIS shall have the right to participate, upon its request,
in any statements relating to any such action to the extent feasible under the
circumstances, and the Parties shall keep each other fully informed with respect
to the status thereof. At a Party's request, the other shall provide reasonable
assistance in conducting such recall, market withdrawal or other corrective
action, including, without limitation, providing all pertinent records that the
other Party may reasonably request to assist in effecting such action.
5.5.2 Cost of Recalls or Other Corrective Actions. Except as expressly
otherwise provided below in this Section 5.5, the Parties shall share equally
all costs of a recall, market withdrawal or other corrective action with respect
to PRODUCT in the United States, including the actual cost AVENTIS paid for the
manufacture and supply of such PRODUCT or COMPOUND. Notwithstanding the
foregoing, a Party shall bear any and all costs of a recall, market withdrawal
or other corrective action with respect to PRODUCT in the United States,
including the actual cost AVENTIS paid for the manufacture and supply of such
PRODUCT or COMPOUND, to the extent such recall, market withdrawal or other
corrective action is attributable predominantly to the fault of such Party and
results from:
(a) in the case of GENTA, (i) a negligent or reckless act or
omission or intentional misconduct on the part of GENTA or its AFFILIATES (other
than (*)), including without limitation with respect to oversight of (*) or any
contractor, and not from a negligent or reckless act or omission or intentional
misconduct on the part of AVENTIS, its AFFILIATES or contractors; (ii) to the
extent that GENTA is supplying PRODUCT or COMPOUND to AVENTIS, the failure of
COMPOUND or PRODUCT to be manufactured or shipped by GENTA in compliance with
all applicable laws, rules and regulations, and in accordance with its
applicable specifications, or (iii) any breach by GENTA of applicable laws,
rules or regulations, or the provisions of this AGREEMENT or the Global Supply
Agreement; and
(b) in the case of AVENTIS: (i) a negligent or reckless act or
omission or intentional misconduct on the part of AVENTIS or its AFFILIATES,
including without limitation with respect to oversight of any contractor, and
not from a negligent or reckless act or omission or intentional misconduct on
the part of GENTA, its AFFILIATES or contractors, (ii) the failure of PRODUCT to
be held, shipped or distributed in compliance with all applicable laws, rules
and regulations, and in accordance with its applicable specifications, from and
after its delivery to AVENTIS, (iii) any breach by AVENTIS of applicable laws,
rules or regulations, or the provisions of this AGREEMENT or the Global Supply
Agreement, or (iv) to the extent that AVENTIS is supplying PRODUCT or COMPOUND,
the failure of COMPOUND or PRODUCT to be manufactured or shipped by AVENTIS in
compliance with all applicable laws, rules and regulations, and in accordance
with its applicable specifications.
(*) Represents language that is redacted and subject to Confidential Treatment.
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Notwithstanding the foregoing, neither Party shall have any obligation to
reimburse or otherwise compensate the other Party or its AFFILIATES for any lost
profits or income that may arise in connection with any recall, market
withdrawal or corrective action with respect to PRODUCT.
5.6 Inspections and Inquiries. If either Party or its AFFILIATES are
inspected by or receives inquiries from a REGULATORY AUTHORITY regarding
COMPOUND or PRODUCT, such Party being inspected shall promptly notify the other
Party, but in no event more than forty-eight (48) hours after such inspection or
inquiry. The Party or its AFFILIATES being inspected shall, where practicable,
permit the other Party to participate as an observer with respect to such
inspection or inquiry, and shall provide the other Party with a written report
of any such inspection, noting with specificity any records or documents
reviewed by the regulatory inspector, and including copies of any FDA 483s or
written communications provided by any REGULATORY AUTHORITY relating to such
inspection. Such Party or its AFFILIATES shall also provide an opportunity for
the other Party to assist in responding to any issues or concerns relating to
such inspections, and shall provide copies of all communications to and from any
REGULATORY AUTHORITY relating thereto. When a copy of a document or record is
supplied to an inspector on request, that fact will be noted in the report. The
Party or its AFFILIATES being inspected shall keep copies of each of these
records or documents in a separate inspection file and, on the other Party's
request, will provide copies of any or all of these documents or records. The
Parties shall cooperate in good faith and otherwise mutually support any
inspections by the FDA of AVENTIS' or its AFFILIATES' (or their suppliers)
facilities or clinical investigators, and any inspections by other REGULATORY
AUTHORITIES of GENTA's or its AFFILIATES' (or their suppliers) facilities or
clinical investigators.
5.7 Medical Inquiries. The U.S. Commercialization Team shall delegate
responsibility for responding to medical questions or inquiries from members of
the medical and paramedical professions and consumers regarding PRODUCT in the
United States. Each Party shall refer all such questions about PRODUCT that it
receives to the Party or Parties responsible for responding thereto as set forth
herein, and each Party shall inform the other Party of any answers given, all in
accordance with the laws, regulations and policies of the FDA. The Parties shall
work together to formulate, and shall mutually agree upon, responses to such
inquiries, including the content of any Frequently Asked Questions (FAQs). If
appropriate, the Parties shall establish a centralized database to document and
track medical inquiries.
5.8 Promotional Materials. Both Parties must approve all promotional
materials for PRODUCT in the United States. Each Party shall send the other
Party a sample thereof, and the other Party's regulatory compliance personnel
shall review and either approve or state their reasons for disapproval of such
materials to the first Party in writing within ten (10) business days following
its receipt of such sample. Promotional materials not approved within such ten
(10) business day period shall be deemed rejected, and the matter shall be
referred to the U.S. Commercialization Team for prompt resolution. As holder of
the NDA APPROVALS for PRODUCT in the United States, GENTA shall be responsible
for all interactions with the FDA regarding approval of all promotional
materials regarding PRODUCT that require FDA approval. GENTA shall promptly
forward all such materials to FDA for such approval, shall keep AVENTIS fully
informed of its interaction with the FDA with respect thereto, and shall be
diligent in seeking prompt approval by the FDA thereof. Each Party shall comply
with all
(*) Represents language that is redacted and subject to Confidential Treatment.
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applicable laws and regulations and obtain all appropriate governmental
approvals pertaining to the packaging, labeling, sales, marketing and
distribution of the PRODUCT.
6. ADDITIONAL DEVELOPMENT FUNDING.
6.1 Upfront Payment. In connection with the funding of development of
PRODUCT, AVENTIS shall pay GENTA, upon the execution of this AGREEMENT, Forty
Million Dollars ($40,000,000), which amount shall be non-refundable and
non-creditable.
6.2 Milestone Payments. In connection with the funding of ongoing
development of PRODUCT, AVENTIS shall pay GENTA the non-refundable and
non-creditable amounts set forth below within fifteen (15) business days after
AVENTIS receives written notice from GENTA of the first occurrence of each event
specified below, together with a copy of the applicable NDA APPROVAL or MAA
APPROVAL letter (each, an "Event"), (*):
6.2.1 Events and Payments.
Event Payment
----- -------
A) (*) $40 Million
B) Receipt of NDA APPROVAL for PRODUCT for the first indication: $35 Million
C) Receipt of NDA APPROVAL for PRODUCT for the second indication: $40 Million
D) Receipt of NDA APPROVAL for PRODUCT for the first MAJOR
INDICATION: $40 Million
E) First receipt of MAA APPROVAL in any MAJOR EUROPEAN COUNTRY
for PRODUCT for the first MAJOR INDICATION (which may be the
same or different than the MAJOR INDICATION referred to in
Event D above): $20 Million
F) First receipt of NDA APPROVAL for PRODUCT for the FIRST-LINE
TREATMENT of any MAJOR INDICATION, as reflected in the
approved labeling for such PRODUCT: $40 Million
G) First receipt of MAA APPROVAL for PRODUCT in any MAJOR
EUROPEAN COUNTRY for the FIRST-LINE TREATMENT of any MAJOR
INDICATION (which may be the same or different from the MAJOR
INDICATION referred to in Event F above), as reflected in the
approved labeling for such PRODUCT: $20 Million
H) Receipt of NDA APPROVAL for PRODUCT for the second MAJOR
INDICATION: $45 Million
6.2.2 (*):
(*) Represents language that is redacted and subject to Confidential Treatment.
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(a) (*).
(b) (*).
(c) (*).
(d) (*).
6.2.3 One Payment Per Event. (*), it is understood that the
occurrence of an Event shall trigger only one of the payments pursuant to
Section 6.2.1 (B) through (H) above, and that each such payment shall be made
only once regardless of whether the corresponding milestone is achieved more
than once. Approvals for new formulations, dosages or delivery systems for
indications previously approved shall not trigger the payment of any additional
milestones. If the MAA APPROVAL of a particular indication in a particular
country would trigger more than one payment under (B) through (H) above (for
example if the NDA APPROVAL in the United States for the first MAJOR INDICATION
also is approved as a FIRST LINE TREATMENT for such MAJOR INDICATION), then only
one payment shall be due (i.e., the payment specified under one of (B)-(H)), and
GENTA may select
(*) Represents language that is redacted and subject to Confidential Treatment.
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which such payment shall be due, with the non-selected payment to be paid upon
the next occurrence of such Event, if any. Notwithstanding the above, pursuant
to Section 6.2.1 the same indication may trigger the milestone payment under
both Event D and Event E, or both Event F and Event G, and the same indication
may trigger the milestone payment under Event A ((*)) and any other Event.
6.2.4 (*).
7. U.S. COMMERCIALIZATION AND PROMOTION.
7.1 U.S. Marketing Plan. GENTA and AVENTIS shall work together to
commercialize and promote the PRODUCT in the United States, and each Party shall
have a meaningful role and participation in such commercialization and promotion
of the PRODUCT in the United States, including planning and strategy and
execution of activities. The U.S. Commercialization Team shall prepare a
marketing plan for the United States within six (6) months after the Effective
Date, such plan to specify the objectives and activities of AVENTIS and GENTA
(which objectives and activities shall be substantially consistent with the
budgets, allocations of sales representatives and other items set forth in
Exhibit 7.1 to the extent relevant thereto) related to the prelaunch, launch,
promotion and sale of PRODUCT in the United States (the "U.S. Marketing Plan").
AVENTIS and GENTA shall use COMMERCIALLY REASONABLE EFFORTS to implement the
U.S. Marketing Plan, and the U.S. Commercialization Team will review the
progress of AVENTIS' and GENTA's efforts under the U.S. Marketing Plan on an
ongoing basis. The U.S. Commercialization Team may make changes to the U.S.
Marketing Plan that it deems appropriate, and in any event the U.S.
Commercialization Team shall revise and update the U.S. Marketing Plan on an
annual basis, subject to each Party's undertakings pursuant to this AGREEMENT.
AVENTIS and GENTA shall each devote such resources as are reasonably necessary
for it to perform its obligations under the U.S. Marketing Plan. Neither Party
shall conduct any activities relating to the marketing or promotion of PRODUCT
or COMPOUND in the United States other than in accordance with the U.S.
Marketing Plan; provided, however, that GENTA shall be permitted to engage in
marketing and promotion activities with respect to PRODUCT and COMPOUND, at
(*) Represents language that is redacted and subject to Confidential Treatment.
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its expense, outside of the U.S. Marketing Plan as long as (i) such activities
are coordinated in advance with the activities being or to be conducted under
U.S. Marketing Plan, and (ii) the U.S. Commercialization Team has not withheld
its consent to such activities, such consent not to be unreasonably withheld.
GENTA and AVENTIS shall use COMMERCIALLY REASONABLE EFFORTS to coordinate their
respective activities.
7.2 (*) :
7.2.1 (*).
(a) (*).
(b) (*).
(c) (*).
(*) Represents language that is redacted and subject to Confidential Treatment.
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(d) (*).
(e) (*).
7.2.2 (*).
7.3 Reimbursement. AVENTIS shall reimburse GENTA for the cost of the GENTA
Sales Rep FTEs, and for such other activities performed by GENTA in accordance
with the U.S. Marketing Plan, calculated as set forth in this Section 7.3.
7.3.1 (*).
7.3.2 (*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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(*).
7.3.3 Within fifteen (15) days following the end of each CALENDAR
QUARTER during which GENTA is participating with AVENTIS in detailing PRODUCT in
the United States, GENTA shall submit to AVENTIS a report reasonably detailing
GENTA's good faith estimate of the GENTA Sales Reps deployed by GENTA during
such CALENDAR QUARTER, if such individuals did not participate in the detailing
of PRODUCT for the entire CALENDAR QUARTER, when such individuals started and
ended such participation, whether such individuals participated in the detailing
of any products other than PRODUCT, if such individuals did participate in the
detailing of any such other products, the relative time that such individuals
spend detailing such other products versus the time they spent detailing
PRODUCT, and any other activities performed by GENTA in accordance with the U.S.
Marketing Plan for which GENTA is seeking reimbursement hereunder. Within forty
(40) days following the end of each CALENDAR QUARTER, GENTA shall submit to
AVENTIS a final report reasonably detailing the items described in the preceding
sentence. Payment of amounts to be reimbursed under this Section 7.3 shall be
made in accordance with the provisions of Section 11.3 below.
7.4 Sales Rep Performance. Each Party will use COMMERCIALLY REASONABLE
EFFORTS in performing its designated activities under the U.S. Marketing Plan,
and to ensure that its sales force is adequately trained with respect to
PRODUCT.
7.5 Booking Sales. During the term of this AGREEMENT, AVENTIS will book all
NET SALES for PRODUCT in the United States.
7.6 Promotional Materials. In connection with its marketing and promotion
of PRODUCT within the United States, each Party shall make and use only claims,
promotional materials, PRODUCT samples, advertising and literature approved by
the U.S. Commercialization Team. The Party supplying any promotional materials
with respect to PRODUCT for use in the United States shall supply to the other
Party's sales representatives, if any, reasonable quantities of such materials
for use in performing such other Party's obligations under the U.S. Marketing
Plan.
7.7 Information Exchange. Each Party shall keep the U.S. Commercialization
Team reasonably informed as to such Party's activities in connection with the
marketing, sale, promotion, distribution and other commercialization of PRODUCT
in the United States. In addition, AVENTIS shall provide GENTA with unaudited
monthly sales reports of NET SALES in the United States.
7.8 Pre-Clinical Research and Activities. Each Party and its AFFILIATES, at
such Party's expense, shall be free to conduct such internal preclinical
research and activities with respect to COMPOUND and PRODUCT as such Party
reasonably determines are appropriate. Each Party and its AFFILIATES, at such
Party's expense, shall be free to conduct external pre-clinical research and
activities with respect to COMPOUND and PRODUCT (i.e., activities performed by
or with THIRD PARTIES) provided that (i) such activities are coordinated in
advance with the activities being or to be conducted under the U.S. Marketing
Plan, and (ii) the
(*) Represents language that is redacted and subject to Confidential Treatment.
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U.S. Commercialization Team has not withheld its consent to such activities,
which consent shall only be withheld if the U.S. Commercialization Team
reasonably believes that such activities will have an adverse effect on the
commercialization efforts related to COMPOUND or PRODUCT. To the extent
necessary for the conduct of any such external activities, a Party shall be
permitted to supply the THIRD PARTY performing or with whom such Party is
performing such activities with reasonable quantities of COMPOUND or PRODUCT
under the terms of such Party's standard materials transfer agreement.
8. DILIGENCE.
8.1 Commercially Reasonable Efforts. Without limiting the Parties'
obligations under this AGREEMENT, each Party shall use COMMERCIALLY REASONABLE
EFFORTS to develop COMPOUND (including any OTHER COMPOUND that the Parties add
to the definition of COMPOUND) and PRODUCT, and to commercialize COMPOUND
(including any OTHER COMPOUND that the Parties add to the definition of
COMPOUND) and PRODUCT in the United States, including (a) with respect to
AVENTIS, obtaining MAA APPROVALS for PRODUCT in all MAJOR COUNTRIES for all
MAJOR INDICATIONS, and with respect to GENTA, obtaining NDA APPROVALS for
PRODUCT in the United States for all MAJOR INDICATIONS, (b) launching PRODUCT in
the United States for each approved indication within a reasonable period of
time after appropriate NDA APPROVAL has been obtained for such indication, and
(c) after the FIRST COMMERCIAL SALE of PRODUCT in the United States for a
particular indication, to promoting sales of such PRODUCT in the United States.
8.2 Assistance. Each Party shall use COMMERCIALLY REASONABLE EFFORTS to
assist the other Party in achieving the goals specified in Section 8.1, subject
to the remaining provisions of this AGREEMENT and the Ex-U.S. Commercialization
Agreement.
9. PRODUCT SUPPLY AND DISTRIBUTION.
9.1 Global Supply Agreement. Simultaneously with their execution of this
AGREEMENT, the Parties and AVENTIS IRELAND are executing the Global Supply
Agreement. Under the Global Supply Agreement, GENTA will supply AVENTIS and
AVENTIS IRELAND with PRODUCT on a global basis. To the extent of any
inconsistency between the provisions of this AGREEMENT and the provisions of the
Global Supply Agreement, the provisions of this AGREEMENT shall govern.
10. FEES & REVENUE SHARING.
10.1 Initial Fee. In connection with the rights granted to AVENTIS under
this AGREEMENT, AVENTIS shall pay GENTA, upon the execution of this AGREEMENT,
Ten Million Dollars ($10,000,000), which amount shall be non-refundable and
non-creditable.
10.2 Revenue Sharing. AVENTIS shall pay to GENTA the following amounts
during the term of this AGREEMENT:
(*) Represents language that is redacted and subject to Confidential Treatment.
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10.2.1 (*).
10.2.2 (*).
10.2.3 Free Product. The Parties, as approved by the U.S.
Commercialization Team, may use and distribute reasonable quantities of PRODUCT
in the United States other than through commercial sales, including without
limitation for training programs, educational programs, samples, clinical or
preclinical studies, reimbursement assistance programs, or other agreed upon
uses (collectively "Free Product"). No payments shall be due and owing to GENTA
under this Section 10.2 on account of any distribution or use of Free Product.
10.2.4 Payment. Within fifteen (15) days following the end of each
CALENDAR QUARTER, AVENTIS shall provide GENTA a preliminary report reasonably
detailing AVENTIS' good faith estimate of US NET SALES for such CALENDAR QUARTER
and the estimated amounts due to GENTA under this Section 10.2 on account
thereof. Within forty (40) days following the end of each CALENDAR QUARTER,
AVENTIS shall provide GENTA a final report reasonably detailing AVENTIS'
calculation of US NET SALES for such CALENDAR QUARTER and the amounts due to
GENTA under this Section 10.2 on account thereof. Payment of amounts due to
GENTA under this Section 10.2 shall be made in accordance with the provisions of
Section 11.3 below.
10.3 Third Party Royalties. GENTA shall be solely responsible for paying
any and all royalties, sublicensing fees and other amounts owed under the GENTA
THIRD PARTY AGREEMENTS by reason of the activities contemplated under this
AGREEMENT, the Ex-U.S. Commercialization Agreement, or the Global Supply
Agreement.
(*) Represents language that is redacted and subject to Confidential Treatment.
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10.4 Discounting; Combination Pricing. If AVENTIS, its AFFILIATES or their
MARKETING DISTRIBUTORS sell PRODUCT to a customer who also purchases other
products or services from any such entity, AVENTIS agrees not to, and to require
its AFFILIATES and their MARKETING DISTRIBUTORS not to, discount or price
PRODUCT in a manner that is intended to disadvantage PRODUCT in order to benefit
sales or prices of other products offered for sale by AVENTIS, its AFFILIATES or
their MARKETING DISTRIBUTORS to such customer.
11. PAYMENTS; REPORTING; BOOKS AND RECORDS.
11.1 Payment Method. All payments under this AGREEMENT shall be made by
bank wire transfer in immediately available funds to an account designated by
the Party to which such payments are due. Any payments due under this AGREEMENT
which are not paid by the date such payments are due under this AGREEMENT shall
bear interest to the extent permitted by applicable law at a rate equal to the
thirty (30) day London Inter-Bank Offering Rate ("LIBOR") U.S. Dollars, as
quoted in The Financial Times effective for the date on which the payment was
due. This Section 11.1 shall in no way limit any other remedies available to the
Parties.
11.2 U.S. Dollars. All sums due under this AGREEMENT shall be payable in
U.S. Dollars. Currencies other than U.S. Dollars shall be converted into U.S.
Dollars as set forth herein:
11.2.1 For purposes of (*) above with respect to sales of PRODUCT made
in currencies other than U.S. Dollars, each month's NET SALES will be converted
to U.S. Dollars using the spot rates (the "Closing mid-point rates" found in the
"Dollar spot forward against the Dollar" table published by The Financial Times,
or any other publication as agreed to by the Parties) from the last business day
of that month.
11.2.2 With respect to DEVELOPMENT COSTS incurred by AVENTIS in
currencies other than U.S. Dollars, such costs shall be converted to U.S.
Dollars using the spot rates utilized by AVENTIS generally in accordance with
its policies for intercompany rebilling, as consistently applied.
11.3 Timing of Payments; Reconciliation. Subject to AVENTIS' timely receipt
from GENTA of all quarterly reports to be provided to AVENTIS under Sections
4.4.1, 4.4.3, and 7.3.3 above, AVENTIS shall, within fifty-five (55) days
following the end of each CALENDAR QUARTER, prepare and provide GENTA with a
report detailing the amounts due under Sections 4.4.1, 4.4.3, 7.3.3 and 10.2.4
above, and reconciling such amounts so as to determine a single payment that one
Party is required to make to the other Party by reason of their cross-payment
obligations under such Sections. If AVENTIS is the party owing such single
payment, it shall make such payment to GENTA within five (5) days after the date
that such report is due to GENTA. If GENTA is the party owing such single
payment, it shall make such payment to AVENTIS within five (5) days after its
receipt of such report from AVENTIS.
11.4 Taxes. AVENTIS shall be entitled to deduct from all payments due under
this AGREEMENT the amount of all applicable U.S. state and local taxes
(excluding taxes based on the net income of GENTA) to the extent AVENTIS pays
such taxes to the appropriate
(*) Represents language that is redacted and subject to Confidential Treatment.
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governmental authority on behalf of GENTA. AVENTIS shall properly furnish GENTA
with copies of tax receipts evidencing the payment of all such taxes, levies and
assessments. GENTA and AVENTIS shall cooperate with each other in obtaining any
exemption from or reduced rate of tax available under any applicable law or tax
treaty. Notwithstanding the foregoing, AVENTIS shall be liable for, and
indemnify GENTA against, any non-U.S. taxes, any value-added or sales taxes, any
duties or levies and assessments, howsoever designated or computed that are
required to be paid or withheld by AVENTIS on such payments. Notwithstanding
anything in this AGREEMENT to the contrary, in the event that withholding taxes
are paid on behalf of GENTA by AVENTIS, if GENTA uses a foreign tax credit
received as a result of the payment of withholding taxes by AVENTIS and thereby
reduces the amount of U.S. income tax that GENTA otherwise would have paid,
GENTA shall refund to AVENTIS the amount of such reduction with respect to such
foreign tax credit.
11.5 Audit Rights. Each Party shall keep, and require its AFFILIATES and,
in the case of AVENTIS, their MARKETING DISTRIBUTORS to keep, complete, true and
accurate books of accounts and records for the purpose of determining the
amounts payable or owed pursuant to this AGREEMENT (including without limitation
Section 10.2). Such books and records shall be kept at the principal place of
business of each Party, its AFFILIATES and such MARKETING DISTRIBUTORS for at
least five (5) years following the end of the calendar quarter to which they
pertain. Such records will be open for inspection during such five (5) year
period by an independent auditor chosen by the other Party and reasonably
acceptable to both Parties for the purpose of verifying the amounts payable
hereunder. Such inspections may be made no more than once each CALENDAR YEAR, at
reasonable times and on reasonable notice and once the records for a period are
audited they shall not be subject to re-audit. The independent auditor shall be
obligated to execute a reasonable confidentiality agreement prior to commencing
any such inspection. Inspections conducted under this Section 11.5 shall be at
the expense of the auditing Party, unless a variation or error producing an
underpayment in amounts payable exceeding five percent (5%) of the amount paid
for the entire period covered by the inspection is established in the course of
any such inspection, whereupon all reasonable out-of-pocket costs relating to
the inspection for such period (up to the amount of the underpayment) and any
unpaid amounts that are discovered shall be paid by the audited Party, together
with interest on such unpaid amounts at the rate set forth in Section 11.1
above. The Parties will endeavor to minimize disruption of the audited Party's
normal business activities to the extent reasonably practicable.
12. CONFIDENTIALITY.
12.1 Nondisclosure. "Confidential Information" means any information, data,
or know-how which the disclosing Party treats confidentially and identifies as
confidential or which the recipient knows or should have reason to believe is so
treated. Each Party shall not (and shall require that its AFFILIATES and, in the
case of AVENTIS, their MARKETING DISTRIBUTORS do not) use or reveal or disclose
to THIRD PARTIES any Confidential Information received from the other Party
without first obtaining the written consent of the disclosing Party, except as
may be reasonably necessary in performing such Party's obligations or exercising
such Party's rights under this AGREEMENT. Each Party may disclose any
Confidential Information received from the other Party to its AFFILIATES and, in
the case of
(*) Represents language that is redacted and subject to Confidential Treatment.
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AVENTIS, their MARKETING DISTRIBUTORS, on a need-to-know basis only, and such
Party shall be responsible for its AFFILIATES' and, in the case of AVENTIS,
their MARKETING DISTRIBUTORS', compliance with the provisions of this Section 12
with respect thereto. Each Party shall take (and shall require its AFFILIATES
and, in the case of AVENTIS, their MARKETING DISTRIBUTORS to take) reasonable
steps to prevent any unauthorized use or disclosure of the other Party's
Confidential Information to THIRD PARTIES. The obligations of confidentiality
under this Section shall remain in effect until the later of five (5) years
after any termination of the term of this AGREEMENT, or fifteen (15) years
following the Effective Date.
12.2 Exceptions. The confidentiality obligations in this Section 12 shall
not apply to information which (a) is or becomes a matter of public knowledge
through no fault of the receiving Party or any person to whom the receiving
Party provided such information, or (b) is or was already in the possession of
the receiving Party at the time of disclosure by the disclosing Party, or (c) is
disclosed to the receiving Party by a THIRD PARTY having the right to do so, or
(d) is subsequently and independently developed by or on behalf of the receiving
Party or its AFFILIATES by persons having no access to the disclosing Party's
Confidential Information, (e) is reasonably required to be disclosed in
connection with obtaining or maintaining MAA APPROVALS for PRODUCT, or (f) is
required by law to be disclosed, provided that the receiving Party uses
reasonable efforts to give the disclosing Party advance notice of such required
disclosure in sufficient time to enable the disclosing Party to seek
confidential treatment for such information, and provided further that the
receiving Party limits the disclosure to that information which is required to
be disclosed.
12.3 Terms of Agreement. Except as set forth below, no announcement or
other disclosure, public or otherwise, concerning the financial or other terms
of this AGREEMENT shall be made, either directly or indirectly, by any Party to
this AGREEMENT, except as may be legally required, without first obtaining the
written approval of the other Party and agreement upon the nature and text of
such announcement or disclosure, such approval and agreement not to be
unreasonably withheld. The Party desiring to make any announcement or other
disclosure concerning the terms of this AGREEMENT shall provide the other Party
with a copy of the proposed announcement or disclosure for review and comment in
reasonably sufficient time prior to undertaking the announcement or disclosure.
Each Party agrees that it shall reasonably cooperate with the other with respect
to all disclosures regarding this AGREEMENT to the Securities Exchange
Commission and any other governmental or regulatory agencies. In addition, the
Parties will coordinate in advance with each other on the terms of this
AGREEMENT that the Parties shall seek to be redacted in any SEC filings, and
each Party shall use reasonable efforts to seek confidential treatment for such
terms, provided that each Party shall ultimately retain control over what
information to disclose to the SEC or any other such agencies. The Parties will
mutually agree upon the contents of a joint press release (and accompanying Q&A)
which shall be issued simultaneously by both Parties upon the Effective Date.
Notwithstanding the above, the Parties shall be free to publicly disclose
information contained in such press release or Q&A, or in any other materials
that have been previously approved for disclosure by the other Party, without
further approvals from the other Party hereunder, to the extent there have been
no material additions or changes thereto.
12.4 Publications and Public Presentations. Neither Party shall submit for
written or oral publication, or present at any public conference or meeting, any
manuscript, abstract, talk,
(*) Represents language that is redacted and subject to Confidential Treatment.
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handout or the like that includes DATA or other information concerning the
safety or efficacy of PRODUCT that is not publicly known without first obtaining
the prior written consent of the other Party, such consent not to be
unreasonably withheld. The contribution of each Party, if any, shall be noted in
all publications or presentations by acknowledgment or co-authorship, whichever
is appropriate. The foregoing shall not prohibit either Party from assisting in
the submission of data or information on behalf of a THIRD PARTY investigator.
13. INTELLECTUAL PROPERTY.
13.1 Proprietary Rights, Inventions.
13.1.1 As between the parties, GENTA shall retain sole ownership of
and exclusive title to the GENTA TECHNOLOGY and the GENTA PATENT RIGHTS. Any and
all inventions resulting from the activities conducted by either Party's
employees, agents or contractors under this AGREEMENT (each, an "Invention")
shall be promptly disclosed in writing to the other Party. Inventorship for
patentable Inventions conceived or reduced to practice during the course or as a
result of the performance of such activities shall be determined in accordance
with U.S. patent laws, and ownership of all Inventions shall be determined based
on inventorship. Inventions jointly invented by employees, agents or contractors
of both Parties ("Joint Inventions") shall be jointly owned by both Parties,
and, except as expressly set forth herein, neither Party shall have any
obligations of accounting to the other Party with respect thereto. The Parties
shall cooperate in good faith with respect to the filing, prosecution,
maintenance and enforcement of all patents and patent applications claiming any
Joint Inventions.
13.1.2 Upon the expiration or termination of this AGREEMENT for any
reason other than a material breach by GENTA under Xxxxxxx 00.0, XXXXXXX shall
grant, and hereby grants, to GENTA a non-exclusive, perpetual, irrevocable
license to any of AVENTIS' Inventions reasonably necessary for the manufacture,
use, formulation or delivery of COMPOUND or PRODUCT, solely for sale in the
United States, in such forms as COMPOUND and PRODUCT are being developed or
commercialized as of the date of such expiration or termination. GENTA shall be
permitted to sublicense such rights solely to a marketing partner or distributor
in connection with the promotion, marketing and distribution of COMPOUND or
PRODUCT. Such license rights to GENTA shall be royalty free, except that GENTA
shall be required to reimburse AVENTIS in full for any royalties, licensing
fees, sublicensing fees and other amounts owed by AVENTIS to THIRD PARTIES on
account of GENTA's or its marketing partners' or distributors' use or other
exploitation of such AVENTIS Inventions.
13.2 Transfer of Technology. Upon AVENTIS' request, GENTA shall promptly
disclose to AVENTIS such of the GENTA TECHNOLOGY as AVENTIS determines is
reasonably necessary for AVENTIS to perform its obligations or exercise its
rights under this AGREEMENT. The manner of such disclosure shall be as mutually
determined by the Parties in good faith and shall be at no additional cost to
AVENTIS.
(*) Represents language that is redacted and subject to Confidential Treatment.
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13.3 Patent Filing, Prosecution and Maintenance.
13.3.1 Performance by GENTA. GENTA shall file, prosecute and maintain,
or require its licensors to file, prosecute and maintain, all patent
applications and patents included in the GENTA PATENT RIGHTS, and conduct any
interferences, re-examinations, reissues and oppositions with respect thereto,
in the United States, Canada, all member countries of the European Union, Japan
and such other countries in the TERRITORY as either Party shall reasonably
request (collectively, the "GENTA Prosecution Activities"), at GENTA's expense.
In this regard, GENTA shall permit AVENTIS to review reasonably in advance and
to make recommendations concerning the GENTA Prosecution Activities, including,
without limitation, any filings and submissions to the U.S. Patent and Trademark
Office or any foreign counterparts thereof , and GENTA shall consider in good
faith and, where appropriate, shall adopt all reasonable recommendations of
AVENTIS with respect thereto.
13.3.2 Performance by AVENTIS. Should GENTA be unable or unwilling to
perform any of the GENTA Prosecution Activities, GENTA shall provide AVENTIS
with at least sixty (60) days' prior notice (or, if 60 days' prior notice is not
reasonably possible, the longest lesser prior notice as is reasonably possible)
of GENTA's discontinuance thereof. In the event GENTA or its licensors fail to
perform, or it appears that GENTA or its licensors are reasonably likely to fail
to perform, any of the GENTA Prosecution Activities, then AVENTIS, to the extent
not prohibited under GENTA's agreements with its licensors, shall have the right
to perform such activities on GENTA's or its licensors' behalf. In such case,
GENTA shall promptly execute, or shall obtain from its licensors the prompt
execution of, all necessary documents that may be required in order to enable
AVENTIS to perform the GENTA Prosecution Activities on GENTA's or its licensors'
behalf. All costs incurred by AVENTIS in performing any of the GENTA Prosecution
Activities shall be deductible in full from any amounts due and owing by AVENTIS
to GENTA under this AGREEMENT.
13.3.3 Cooperation. Each Party shall keep the other Party reasonably
informed as to the status of all GENTA Prosecution Activities being conducted by
such Party. Each Party shall each reasonably cooperate with and assist the other
Party in connection with such activities at such Party's own expense and upon
the other Party's request, including, without limitation, by making scientists
and scientific records reasonably available to the prosecuting Party.
13.4 U.S. Patent Infringement Claims.
13.4.1 Each Party shall give the other prompt written notice of any
suit or action by a THIRD PARTY against either Party for patent infringement
involving the manufacture, use, sale, distribution or marketing of COMPOUND or
PRODUCT in the United States, or to invalidate or assert non-infringement of any
of the GENTA PATENT RIGHTS under which PRODUCT is being manufactured, sold,
used, distributed or marketed in the United States, or upon the filing of an
abbreviated new drug application related to related to COMPOUND or PRODUCT
(each, a "U.S. Patent Infringement Claim"). With respect to each U.S. Patent
Infringement Claim, the Parties shall determine by mutual agreement, within
twenty (20) days following their receipt of notice of the commencement of or
assertion of such U.S. Patent Infringement Claim (or such lesser period of time
as may be required to properly respond to such claim) which Party shall assume
the lead role in the defense thereof. Should the Parties be
(*) Represents language that is redacted and subject to Confidential Treatment.
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unable to mutually agree on who shall assume the lead role in the defense of any
U.S. Patent Infringement Claim, AVENTIS shall be entitled to assume such role,
and if AVENTIS declines or fails to diligently assume such role, GENTA shall be
entitled to assume such role.
13.4.2 The Party assuming the lead role in the defense of any U.S.
Patent Infringement Claim (the "Controlling Party") shall consult with the other
Party on all material aspects of the defense, including, without limitation,
settlement, of such claim, the other Party shall have a reasonable opportunity
to participate in decision-making with respect to the strategy of such defense,
and the Parties shall reasonably cooperate with each other in connection with
the implementation thereof. The non-defending Party shall also have the right to
participate in the defense of any U.S. Patent Infringement Claim utilizing
attorneys of its choice, at its own expense. In furtherance of the Parties'
cooperation, the Controlling Party will consult with the other Party regarding
strategic decisions, including, without limitation, the retention of counsel for
defense of any U.S. Patent Infringement Claim. The Controlling Party will
otherwise keep the other Party reasonably informed of the status and progress of
the defense and any settlement discussions concerning each U.S. Patent
Infringement Claim, and the Parties shall provide each other with all reasonably
requested assistance and will reasonably cooperate with each other in connection
therewith. (*).
13.4.3 The Parties shall share equally in all LOSSES arising out of or
resulting from any U.S. Patent Infringement Claim to the extent relating to any
COMPOUND or PRODUCT, as well as any and all royalties, licensing fees and other
amounts owed under any agreements respecting the settlement of such U.S. Patent
Infringement Claim. The Parties shall establish such procedures as are
reasonably necessary to permit them to reconcile their actual payments for such
LOSSES with their percentage share of responsibility for such LOSSES on a
quarterly basis, within sixty (60) days following the end of each CALENDAR
QUARTER.
13.4.4 U.S. Patent Infringement Claims shall be governed exclusively
by this Section 13.4 and, except in accordance with this Section 13.4, neither
Party shall seek from the other Party any indemnity or other recovery on account
of any such claims; provided, however, that nothing in this Section 13.4 shall
limit either Party's liability to the other for damages on account of any breach
by such Party of its representations, warranties, covenants or agreements under
Section 17.1 or Section 17.2 below.
13.5 License of Third Party Rights.
13.5.1 Freedom to Operate License Rights. If GENTA or AVENTIS
reasonably determines that a license to any PATENT RIGHTS or TECHNOLOGY of a
THIRD PARTY not already included in the GENTA PATENT RIGHTS or the GENTA
TECHNOLOGY is reasonably necessary for the Parties to make, have made, sell,
offer for sale, use or import COMPOUND or PRODUCT then being sold or developed
for sale in the United States, such Party shall provide the other Party with
written notice thereof. Upon the other Party's approval, not to be unreasonably
withheld (taking into account factors that include without limitation the
likelihood and presumption of validity of a THIRD PARTY'S PATENT RIGHTS from a
practical and legal standpoint in the relevant country, the cost of obtaining a
license, and the risks
(*) Represents language that is redacted and subject to Confidential Treatment.
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of not obtaining such license), the Parties shall enter into good faith
discussions with such THIRD PARTY in order to obtain a license to such PATENT
RIGHTS or TECHNOLOGY in order to develop and sell such COMPOUND or PRODUCT in
the United States on terms reasonably acceptable to both Parties, such
acceptance not to be unreasonably withheld or delayed. (*).
13.5.2 Mutually Desired License Rights. If GENTA or AVENTIS reasonably
determines that it would be desirable to obtain license rights to any PATENT
RIGHTS or TECHNOLOGY of a THIRD PARTY not already included in the GENTA PATENT
RIGHTS or the GENTA TECHNOLOGY, other than under the circumstances described in
Section 13.5.1 above, for the Parties to make, have made, sell, offer for sale,
use or import COMPOUND or PRODUCT, or any OTHER COMPOUND or OTHER PRODUCT, for
sale or development for sale in the United States, such Party shall provide the
other Party with written notice thereof. Should the Parties mutually agree that
one or both of them should obtain a license to such PATENT RIGHTS or TECHNOLOGY
for such purposes, they shall enter into good faith discussions with such THIRD
PARTY in order to obtain license rights thereto on terms reasonably acceptable
to both Parties. (*)
13.5.3 Other License Rights. If GENTA and AVENTIS cannot mutually
agree on the terms under which one or both of them should obtain license rights
to any PATENT RIGHTS or TECHNOLOGY of a THIRD PARTY that either Party desires to
obtain under Section 13.5.1 or 13.5.2 above, and if GENTA nonetheless enters
into an agreement to license any such PATENT RIGHTS or TECHNOLOGY from such
THIRD PARTY, such PATENT RIGHTS or TECHNOLOGY shall be excluded from the
definitions of GENTA PATENT RIGHTS and GENTA TECHNOLOGY under this AGREEMENT
unless (*)
13.5.4 Nothing in this Section 13.5 shall limit either Party's rights
or remedies on account of any breach by the other Party of its representations,
warranties, covenants or agreements under Section 17.1 or Section 17.2 below.
13.6 Enforcement Against Third Parties. If either Party reasonably believes
that a THIRD PARTY is manufacturing, selling or using COMPOUND or PRODUCT, or
any OTHER COMPOUND or OTHER PRODUCT, or is otherwise infringing PATENT RIGHTS
controlled by AVENTIS or GENTA that cover COMPOUND or PRODUCT, or any OTHER
COMPOUND or OTHER PRODUCT, such Party shall promptly notify the other Party
hereto.
(*) Represents language that is redacted and subject to Confidential Treatment.
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Promptly after such notice, the Parties shall meet to discuss the course of
action to be taken with respect thereto, including an enforcement action
relating to infringement of the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY,
and, as appropriate, may enter into a joint litigation agreement covering the
control thereof and the Parties shall share equally in all costs and recoveries.
Neither Party shall initiate an infringement suit against such THIRD PARTY with
respect to said activities except as the Parties shall mutually agree, such
agreement not to be unreasonably withheld. Moreover, any settlement or other
similar agreement under which such THIRD PARTY is granted rights under the GENTA
PATENT RIGHTS or the GENTA TECHNOLOGY shall not be inconsistent with the rights
granted to AVENTIS hereunder or under the Ex-U.S. Commercialization Agreement or
the Global Supply Agreement.
13.7 Patent Marking. AVENTIS shall xxxx, and to require its AFFILIATES and
their MARKETING DISTRIBUTORS to xxxx, all patented PRODUCT sold or distributed
pursuant to this AGREEMENT in accordance with the applicable patent statutes or
regulations in the country or countries of manufacture and/or sale thereof.
GENTA shall cooperate in providing all relevant patent and marketing information
for AVENTIS to do so.
13.8 Patent Term Extensions. The Parties shall cooperate to file all
applications and take all actions reasonably necessary to obtain patent
extensions pursuant to 35 USC 156 (or like foreign statutes) for the GENTA
PATENT RIGHTS at GENTA's expense. Each Party shall sign such documents and take
such other actions as may be reasonably requested by the other Party in
connection therewith.
13.9 Conflict with Certain Existing Agreements. To the extent that GENTA is
not authorized under the GENTA THIRD PARTY AGREEMENTS to grant AVENTIS any of
the rights set forth in this Section 13 with respect to the filing, prosecution,
maintenance and/or enforcement of any of the GENTA PATENT RIGHTS, AVENTIS'
rights under this Section 13 shall be limited to those which are permitted under
the GENTA THIRD PARTY AGREEMENTS in a manner to effectuate, to the greatest
extent, the intent and purposes of this Section 13.
14. TRADEMARKS AND COPYRIGHTS.
14.1 Division of Rights. It is the intent of the Parties to develop and use
a single PRODUCT TRADEMARK on and in connection with the marketing, sale,
advertising and/or promotion of PRODUCT worldwide, with GENTA holding all right,
title and interest in and to the PRODUCT TRADEMARK in the United States (subject
to the license rights granted herein), and AVENTIS holding all right, title and
interest in and to the PRODUCT TRADEMARK in the ROW (subject to the terms of the
Ex-U.S. Commercialization Agreement between the Parties). If it is determined
that it is not possible to register or otherwise use the PRODUCT TRADEMARK in
any country of the ROW, AVENTIS shall select an appropriate trademark for
adoption in such country. The U.S. Commercialization Team shall be responsible
for determining the uses of any Internet domain names that include or are
similar to the PRODUCT TRADEMARK (and if GENTA already owns such domain names as
of the Effective Date, GENTA shall pay the registration/renewal costs associated
with any such Internet domain names).
(*) Represents language that is redacted and subject to Confidential Treatment.
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14.2 Display. All packaging materials, package inserts, labels and
marketing, sales, advertising and promotional materials relating to PRODUCT
distributed in the United States shall display the PRODUCT TRADEMARK in a form
and style and with a placement determined by the U.S. Commercialization Team.
The GENTA HOUSEMARK(S) and the AVENTIS HOUSEMARK(S) shall be given similar
exposure and prominence on all such items to the extent permitted by applicable
laws and regulations and subject to obtaining all necessary regulatory
approvals. The appearance of the PRODUCT TRADEMARK, the GENTA HOUSEMARK(S) and
the AVENTIS HOUSEMARK(S) with respect to PRODUCT, shall be determined by the
U.S. Commercialization Team, subject to the remainder of this Section 14.
14.3 Approvals and Quality Control Standards. All use of the GENTA
HOUSEMARK(S) shall be consistent with such quality control standards and
reasonable trademark usage guidelines as GENTA applies to its own proprietary
marks, as such standards and guidelines may be modified and communicated to the
U.S. Commercialization Team in writing. All use of the AVENTIS HOUSEMARK(S)
shall be consistent with such quality control standards and reasonable trademark
usage guidelines as AVENTIS applies to its own proprietary marks, as such
standards and guidelines may be modified and communicated to the U.S.
Commercialization Team in writing. AVENTIS (and GENTA where applicable) shall
submit representative packaging materials, package inserts, labels and
promotional materials for PRODUCT to the U.S. Commercialization Team for its
approval prior to their first use and prior to any subsequent material change or
addition to such items.
14.4 License Rights.
14.4.1 Grant by GENTA. GENTA hereby grants to AVENTIS an exclusive
(subject to GENTA's co-promotion rights under Section 7 above), royalty-free
license to use the PRODUCT TRADEMARK and the GENTA HOUSEMARK(S) on and in
connection with the marketing, sale, advertising and/or promotion of PRODUCT in
the United States during the term of this AGREEMENT, and thereafter on a
non-exclusive basis during the Trailing Period. At no additional cost, AVENTIS
shall have the right to grant sublicenses to the foregoing license rights to its
AFFILIATES and their MARKETING DISTRIBUTORS. AVENTIS acknowledges that the
ownership and all goodwill from the use of the PRODUCT TRADEMARK in the United
States and the GENTA HOUSEMARK(S) shall vest in and inure to the benefit of
GENTA.
14.4.2 Grant by AVENTIS. AVENTIS hereby grants to GENTA a
non-exclusive, royalty-free license to use the AVENTIS HOUSEMARK(S) in the
United States solely in conjunction with GENTA's exercise of its co-promotion
rights under Section 7 above. GENTA acknowledges that the AVENTIS HOUSEMARK(S)
are the exclusive property of AVENTIS, and that nothing in this AGREEMENT grants
GENTA or any person or entity any rights, title or interest therein, except for
the license rights expressly granted hereunder. GENTA may not assign or
sublicense any rights in and to the AVENTIS HOUSEMARK(S) to any THIRD PARTY
without the prior written approval of AVENTIS. GENTA acknowledges the ownership
and all goodwill from the use of the AVENTIS HOUSEMARK(S) shall vest in and
inure to the benefit of AVENTIS.
14.5 Registration. GENTA shall file, register and maintain an appropriate
registration for the PRODUCT TRADEMARK for use with PRODUCT in the United States
for the term of
(*) Represents language that is redacted and subject to Confidential Treatment.
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this AGREEMENT at GENTA's sole expense. AVENTIS shall not register or attempt to
register the PRODUCT TRADEMARK, or any confusingly similar variations thereof,
in the United States for the term of this AGREEMENT, nor shall AVENTIS at any
time register or attempt to register the GENTA HOUSEMARK(S), or any confusingly
similar variations thereof, anywhere in the TERRITORY. GENTA shall not register
or attempt to register any trade/service xxxx, symbol, logo and/or trade dress
that is a confusingly similar variation of the PRODUCT TRADEMARK in the United
States for the term of this AGREEMENT, nor shall GENTA at any time register or
attempt to register the AVENTIS HOUSEMARK(S), or any confusingly similar
variations thereof, anywhere in the TERRITORY.
14.6 Enforcement.
14.6.1 Cooperation. AVENTIS and GENTA shall cooperate with each other
and use reasonable efforts to protect their respective marks, including the
PRODUCT TRADEMARK, from infringement by THIRD PARTIES. Without limiting the
foregoing, each Party shall promptly notify the other party of any known,
threatened or suspected infringement, imitation or unauthorized use of or unfair
competition relating to the PRODUCT TRADEMARK, the AVENTIS HOUSEMARK(S) or the
GENTA HOUSEMARK(S).
14.6.2 AVENTIS and GENTA Marks. AVENTIS reserves the right to
determine, in its sole discretion, whether and to what extent to institute and
prosecute or defend any actions or proceedings involving or affecting the
AVENTIS HOUSEMARK(S). GENTA reserves the right to determine, in its sole
discretion, whether and to what extent to institute and prosecute or defend any
actions or proceedings involving or affecting the GENTA HOUSEMARK(S). Each Party
shall reasonably cooperate with the other Party in any action taken by the other
Party to enforce, or defend, its respective rights in such marks, at the expense
of the respective xxxx owner. The respective owner of the infringed xxxx shall
have the sole right, at its expense, to defend and settle for monetary or other
damages any claim made by a third party alleging that the use of such marks
infringe the rights of others.
14.6.3 Product Trademark. GENTA shall have the first right to
determine in its discretion whether to and to what extent to institute,
prosecute and/or defend any action or proceedings involving or affecting any
rights relating to the PRODUCT TRADEMARK in the United States, subject to
AVENTIS' right to consent to any proposed settlement thereof, which consent
shall not be unreasonably withheld. Upon GENTA's reasonable request, AVENTIS
shall cooperate with and assist GENTA in any of GENTA's enforcement efforts with
respect to the PRODUCT TRADEMARK in the United States. If GENTA determines not
to take action against any actual or suspected infringement of the PRODUCT
TRADEMARK in the United States within thirty (30) days after having become aware
of such infringement, or if GENTA otherwise fails to diligently pursue cessation
of the infringing activity, then AVENTIS shall have the right, but not the
obligation, to bring or assume control of any action against the allegedly
infringing THIRD PARTY as AVENTIS determines may be necessary in its sole
discretion. In the event that AVENTIS brings or assumes control of any such
action, then GENTA agrees to reasonably assist AVENTIS in connection therewith.
The Parties shall share equally in all costs and expenses reasonably incurred by
either of them in connection with any such action, and, following each Party's
recovery of its respective costs and expenses, the Parties will share equally in
all money damages, if any, recovered in connection with such action.
(*) Represents language that is redacted and subject to Confidential Treatment.
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14.7 Avoidance of Confusion. Neither GENTA or AVENTIS, nor any of their
AFFILIATES, shall market, promote, sell and/or distribute in the United States,
or authorize or permit another to market, promote, sell and/or distribute in the
United States, any product other than PRODUCT under the PRODUCT TRADEMARK or any
confusingly similar trademark. AVENTIS and its AFFILIATES shall not, directly or
indirectly, contest the validity of or GENTA's rights in the PRODUCT TRADEMARK
in the United States, or the GENTA HOUSEMARK(S) anywhere in the TERRITORY, or
assist any THIRD PARTY in doing so. GENTA and its AFFILIATES shall not, directly
or indirectly, contest the validity of or AVENTIS' rights in the AVENTIS
HOUSEMARK(S) anywhere in the TERRITORY, or assist any THIRD PARTY in doing so.
In the event that actual confusion should arise, or either Party reasonably
believes that a likelihood of confusion may arise, in connection with the
Parties' respective uses of the PRODUCT TRADEMARK in the United States, or of
the AVENTIS HOUSEMARK(S) or GENTA HOUSEMARK(S) anywhere in the TERRITORY, the
Parties will fully cooperate in an effort to eliminate such confusion and to
avoid the possibility of such a likelihood of confusion.
14.8 Non-Assignment. During the term of this Agreement and, if applicable,
any Trailing Period, GENTA agrees not to assign or transfer its rights in and to
the PRODUCT TRADEMARK, and/or any associated federal or state trademark
registrations or pending applications, or domain name registrations
incorporating the PRODUCT TRADEMARK string, to any THIRD PARTY, except in
connection with a permitted assignment of this AGREEMENT as a whole.
14.9 Copyrights. The Parties shall hold jointly an equal and undivided
interest in and to the copyrights in all packaging, labels, marketing, sales,
advertising or promotional materials relating to the PRODUCT in the United
States ("U.S. Copyrighted Works"); provided that, except as expressly provided
in this AGREEMENT, it is understood that neither Party shall have any obligation
to account to the other for profits or to obtain any approval of the other party
to exploit the U.S. Copyrighted Works by reason of such joint ownership. To the
extent such materials include or incorporate original works of authorship
created by one Party prior to the Effective Date, the other Party shall not use,
or make any proprietary claim with regard to, those pre-existing materials
separate and apart from their use and inclusion in U.S. Copyrighted Works
relating to PRODUCT. GENTA agrees not to register, distribute, display or
otherwise exploit, in any media now known or hereafter developed, the U.S.
Copyrighted Works outside of the United States (except to the extent GENTA is
using the internet and similar electronic mediums for the purpose of conducting
activities within the United States but that may be accessible to users outside
of the United States), and may not assign, license or otherwise transfer to any
THIRD PARTY any interest in and to the U.S. Copyrighted Works without AVENTIS'
prior written consent. The Parties shall cooperate with each other to enforce
and defend, including but not limited to registering with the United States
Copyright Office, their interest in the U.S. Copyrighted Works, and shall take
no action to this end without the consent of the other Party. AVENTIS shall hold
the exclusive right to copy, distribute, display, and create derivatives of the
U.S. Copyrighted Works, in any and all media now know or hereafter developed,
and to enforce, defend or secure registrations for the U.S. Copyrighted Works,
in any countries of the ROW, or to license such rights to any THIRD PARTY, with
no duty to account to GENTA. Each Party will, if requested by the other Party,
supply such documentation or other information required to support any
application or registration of the U.S. Copyrighted Works with any applicable
(*) Represents language that is redacted and subject to Confidential Treatment.
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registry or governmental authority, or to evidence or perfect their rights in
and to the U.S. Copyrighted Works under this Section 14.9.
15. TERM AND TERMINATION.
15.1 Expiration. Unless earlier terminated pursuant to this Section, this
AGREEMENT shall continue in full force and effect until the expiration of the
last to expire or be invalidated of any GENTA G3139 PATENT RIGHTS in the United
States or any other GENTA PATENT RIGHTS in the United States Covering PRODUCT
then being commercialized; provided, however, that the term of this AGREEMENT
shall automatically be extended on a year-to-year basis thereafter unless and
until AVENTIS shall have provided GENTA with at least six (6) months' prior
written notice of its election to let the term of this AGREEMENT expire at the
end of the then-current extension period. For the purposes of this paragraph,
"Covering" means, with respect to a PATENT RIGHT, that, but for a license
granted to a party under a VALID CLAIM included in such PATENT RIGHT, the
practice by a person or entity of an invention claimed in such PATENT RIGHT
would infringe such VALID CLAIM, or, in the case of a PATENT RIGHT that is a
patent application, would infringe a VALID CLAIM in such patent application if
it were to issue as a patent.
15.2 Termination For Breach. Either Party may terminate this AGREEMENT on
written notice to the other Party in the event the other Party shall have: (i)
materially breached any of its representations or warranties hereunder, under
the Ex-U.S. Commercialization Agreement or under the Global Supply Agreement; or
(ii) materially breached or defaulted in the performance of any of its covenants
or agreements hereunder, under the Ex-U.S. Commercialization Agreement or under
the Global Supply Agreement and such breach or default shall have continued for
ninety (90) days after written notice thereof was provided to the Party in
breach or default by the other Party; provided, however, that if such breach or
default is not reasonably capable of cure within ninety (90) days, then such
cure period shall be extended for so long as such Party diligently pursues cure
of such breach, but in no event for longer than an additional ninety (90) days.
Any termination shall become effective immediately or, if there is a cure
period, after the expiry of such cure period. In determining whether a
particular breach or default is "material", the breach or default shall be
viewed in relation to the entirety of this AGREEMENT, the Ex-U.S.
Commercialization Agreement and the Global Supply Agreement, and not in relation
to only the agreement under which such breach or default occurred.
Notwithstanding the foregoing, nothing contained in this Section 15.2 shall
preclude AVENTIS from terminating this AGREEMENT as otherwise expressly
permitted hereunder.
15.3. Termination by AVENTIS. Upon six (6) months prior written notice to
GENTA (the "Exit Notice Period"), AVENTIS may terminate this AGREEMENT in its
sole discretion, (*).
15.4 Cross-Default and Termination. Any material breach or default
permitting a Party to terminate this AGREEMENT under Section 15.2 above shall
also constitute a breach or
(*) Represents language that is redacted and subject to Confidential Treatment.
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default permitting, but not requiring, such Party to terminate the Ex-U.S.
Commercialization Agreement for a material breach or default under Section 13.2
thereof. A Party seeking to terminate the Ex-U.S. Commercialization Agreement by
reason of a material breach or default under this AGREEMENT must do so within
sixty (60) days after providing a termination notice under Section 15.2 above,
or such Party shall have waived its rights to terminate the Ex-U.S.
Commercialization Agreement for such breach or default, provided that if the
termination of this AGREEMENT does not take effect due to a cure of such breach
or default within the applicable cure period, the termination of the Ex-U.S.
Commercialization Agreement shall not be effective. Termination of this
AGREEMENT for any reason other than a material breach or default as permitted
under Section 15.2 above shall result in the automatic termination of the
Ex-U.S. Commercialization Agreement (although such termination of the Ex-U.S.
Commercialization Agreement shall not be deemed a termination for material
breach or default under Section 13.2 thereof). Moreover, termination of both
this AGREEMENT and the Ex-U.S. Commercialization Agreement shall result in the
automatic termination of the Global Supply Agreement.
16. RIGHTS AND DUTIES UPON TERMINATION.
16.1 Outstanding Payment. Payments of amounts owing to either Party under
this AGREEMENT as of its expiration or termination shall be due and payable
within the later of (i) to the extent such amounts can be calculated and a fixed
sum determined at the time of expiration or termination of this AGREEMENT, sixty
(60) days after the date of such expiration or termination, or (ii) ten (10)
days after the date in which such amounts can be calculated and a fixed sum
determined.
16.2 Sale of Remaining Inventory. Upon termination of this AGREEMENT,
AVENTIS shall notify GENTA of the amount of PRODUCT AVENTIS, its AFFILIATES and
their MARKETING DISTRIBUTORS then have on hand or have committed to purchase or
sell in the United States. For a period ending upon the earlier of: (i) AVENTIS,
its AFFILIATES and their MARKETING DISTRIBUTORS sale of all PRODUCT in their
possession on the date of termination of this AGREEMENT, or (ii) within the
twelve (12) month period following such termination (the "Trailing Period"),
AVENTIS, its AFFILIATES and their MARKETING DISTRIBUTORS shall be permitted to
sell all such PRODUCT and GENTA hereby grants a non-exclusive royalty-free
license reasonably necessary to sell such PRODUCT; provided, however, that GENTA
shall have the right to purchase such PRODUCT from AVENTIS at the actual cost
AVENTIS paid for the manufacture and supply of such PRODUCT. Any remaining
quantities of PRODUCT not sold during the Trailing Period shall be destroyed.
16.3 Return of Materials. Within sixty (60) days after expiration of the
Trailing Period, each Party shall destroy or return to the other Party all
tangible items bearing, containing, or contained in, any of the Confidential
Information of the other Party, and shall provide the other Party written
certification of such destruction or return.
16.4 Transfer of Data. Within three (3) months after AVENTIS provides GENTA
with a written notice of termination under Section 15.3 above, or a written
notice that AVENTIS has elected to let this AGREEMENT expire at the end of the
term or the then current extension period (as applicable), or, if this AGREEMENT
is terminated for any other reason, promptly upon such termination, AVENTIS
shall provide GENTA copies of all reasonably necessary
(*) Represents language that is redacted and subject to Confidential Treatment.
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DATA relating to PRODUCT then being sold under this AGREEMENT, and shall assign
to GENTA or its designee(s), or, to the extent not reasonably assignable, permit
GENTA or its designee(s) to reference, such of AVENTIS' U.S. filings,
authorizations and the like (including, without limitation, study protocols,
study results, analytical methodologies, bulk and final product manufacturing
process descriptions, batch records, vendor qualifications, validation
documentation and regulatory documentation) that are reasonably necessary for
GENTA or its designee(s) to continue such sales activities. From and after such
time, all such DATA and information specifically pertaining to the PRODUCT shall
be deemed Confidential Information of GENTA (i.e., to the same extent as if such
information had been first disclosed to AVENTIS by GENTA under this AGREEMENT),
subject to the exceptions described in Section 12.2 (a), (c), (e) or (f) above
(but not subject to the exceptions in Section 12.2 (b) or (d) above).
16.5 Cooperation and Transition. During the six (6) month period
following AVENTIS' written notice of termination under Section 15.3 above, or
AVENTIS' written notice that AVENTIS has elected to let this AGREEMENT expire at
the end of the term or the then current extension period (as applicable), or, if
this AGREEMENT is terminated for any other reason, during the six (6) month
period immediately following such termination, AVENTIS shall use COMMERCIALLY
REASONABLE EFFORTS to cooperate with GENTA to provide for an orderly transition
of the development, regulatory and commercialization activities being performed
by AVENTIS hereunder with respect to PRODUCT in the United States, to GENTA or
its designee(s). In addition, AVENTIS shall cooperate fully to transition to
GENTA upon GENTA's request any arrangement with any contractor from which
AVENTIS had arranged to obtain a supply of COMPOUND or PRODUCT hereunder. In the
event that such materials are manufactured by AVENTIS or its AFFILIATES, then
AVENTIS shall continue to provide GENTA at cost with such materials for the
completion of any clinical trials on-going as of the date of transition, and
shall also supply to GENTA at cost a final, reasonable quantity of material
(bulk product or otherwise) as ordered by GENTA within thirty (30) days after
the date of transition. AVENTIS shall be obligated to produce such quantity of
material ordered by GENTA, but only to the extent that AVENTIS, prior to the
date of transition, was producing such material at a scale which would permit
supply of such quantity in a single batch run, consistent with AVENTIS' past
practices with respect to such COMPOUND or PRODUCT hereunder.
16.6 Trademarks. Upon the expiration or termination of this AGREEMENT
(and, in the event of a termination, following any Trailing Period), GENTA's
right to use the AVENTIS HOUSEMARK(S) anywhere in the TERRITORY, and AVENTIS'
right to use the PRODUCT TRADEMARK in the United States and the GENTA
HOUSEMARK(S) anywhere in the TERRITORY, shall automatically cease.
16.7 Survival. Upon the expiration or termination of this AGREEMENT,
all rights and obligations of the parties under this AGREEMENT shall terminate
except those described in the following Sections: Sections 5.5 (with respect to
PRODUCT purchased and/or sold by AVENTIS during the term of this AGREEMENT or
any applicable Trailing Period), 11.4, 11.5, 12.1-12.4, 13.1.1, 13.1.2, 14.1,
14.5, 14.7, 14.9, 16.1-16.9, 17.3-17.8, 17.10, 18.2, 18.4-18.7, and 18.9-18.14;
and, in addition, to the extent that the Ex-US Agreement survives and the U.S.
Agreement terminates, Sections 4.5, 5.1.3, and 5.1.5 (with references therein to
any Teams
(*) Represents language that is redacted and subject to Confidential Treatment.
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applicable to each of the Parties); and, in addition, to the extent that any
PRODUCT is sold during the Trailing Period defined in Section 16.2, Sections
10.2-10.4, 11.1-11.5, 14.4 and 14.8.
16.8 Other. It is understood that termination or expiration of this
AGREEMENT shall not relieve a Party from any liability which, at the time of
such termination or expiration, has already accrued to the other Party or which
is attributable to a period prior to such termination. Termination or expiration
of the AGREEMENT in accordance with the provisions hereof shall not limit
remedies which may be otherwise available in law or equity with respect to a
breach hereof that occurred prior to such termination.
16.9 Rights in Bankruptcy. All rights and licenses granted under or
pursuant to this AGREEMENT by GENTA to AVENTIS are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and
other similar foreign laws, licenses of rights to "intellectual property" as
defined under Section 101 of the U.S. Bankruptcy Code or such foreign laws.
GENTA agrees that AVENTIS, as a licensee of such rights under this AGREEMENT,
shall retain and may fully exercise all of its rights and elections under the
U.S. Bankruptcy Code and other similar foreign laws. GENTA further agree that,
in the event of the commencement of a bankruptcy proceeding by or against GENTA
under the U.S. Bankruptcy Code, AVENTIS shall be entitled to a complete
duplicate of (or complete access to, as appropriate) any such intellectual
property and all embodiments of such intellectual property, and the same, if not
already in AVENTIS' possession, shall be promptly delivered to it (i) upon any
such commencement of a bankruptcy proceeding upon its written request therefor,
unless GENTA elects to continue to perform all of its obligations under this
AGREEMENT, or (ii) if not delivered under (i) above, upon the rejection of this
AGREEMENT by or on behalf of GENTA upon written request therefor by AVENTIS.
17. WARRANTIES AND REPRESENTATIONS, INDEMNIFICATION AND INSURANCE.
17.1 General Representations. Each Party hereby represents and warrants to
the other Party as follows:
17.1.1 Duly Organized. Such Party is a corporation duly organized,
validly existing and is in good standing under the laws of the jurisdiction of
its incorporation, is qualified to do business and is in good standing as a
foreign corporation in each jurisdiction in which the conduct of its business or
the ownership of its properties requires such qualification and failure to have
such would prevent it from performing its obligations under this AGREEMENT.
17.1.2 Due Execution. The execution, delivery and performance by such
Party of this AGREEMENT have been duly authorized by all necessary corporate
action and do not and will not (i) require any consent or approval of its
stockholders; (ii) violate any provision of any law, rule, regulation, order,
writ, judgment, injunction, decree, determination or award presently in effect
having applicability to it or any provision of its charter or bylaws; or (iii)
conflict with or constitute a default under any other agreement or understanding
to which such Party is a party.
(*) Represents language that is redacted and subject to Confidential Treatment.
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17.1.3 Binding Agreement. This AGREEMENT is a legal, valid and binding
obligation of such Party, enforceable against it in accordance with the terms
and conditions hereof, and such Party is not under any obligation to any person
or entity, contractual or otherwise, that is in conflict with the terms of this
AGREEMENT, nor will such Party undertake any such obligation during the term of
this AGREEMENT.
17.1.4 Authorizations. Such Party has obtained all authorizations,
consents and approvals, governmental or otherwise, necessary for such Party to
grant the rights and licenses granted by such Party under this AGREEMENT, and to
otherwise perform such Party's obligations under this AGREEMENT.
17.1.5 Third-Party Claims. Except for the GENTA THIRD PARTY
AGREEMENTS, neither such Party, nor any of its AFFILIATES, are a party to, or
are otherwise bound by, any oral or written contract that will result in any
person or entity obtaining any interest in, or that would give to any THIRD
PARTY any right to assert any claim in or with respect to, any of such Party's
or the other Party's rights under this AGREEMENT.
17.2 GENTA Additional Representations, Warranties and Covenants. GENTA
hereby represents, warrants, covenants and agrees, except as set forth in detail
in Schedule 17.2 (which schedule shall clearly indicate the subsection of this
Section 17.2 to which an exception is being made), as follows:
17.2.1 Exhibit 1.25 constitutes a correct and complete list of all of
the GENTA G3139 PATENT RIGHTS issued or pending in the TERRITORY as of the
Effective Date. As of the Effective Date, GENTA has no reason to believe that
any of the GENTA PATENT RIGHTS are likely to be held invalid. As of the
Effective Date, to the best of GENTA's knowledge, the GENTA PATENT RIGHTS are in
full force and not subject to any pending or threatened re-examination,
opposition, interference or litigation proceedings.
17.2.2 To the best of GENTA's knowledge as of the Effective Date: (i)
the manufacture, use or sale of COMPOUND or PRODUCT as contemplated hereunder
will not infringe any valid and enforceable PATENT RIGHTS of any THIRD PARTY,
and (ii) the GENTA PATENT RIGHTS with respect to PRODUCT and COMPOUND are not
currently being infringed by any THIRD PARTY.
17.2.3 GENTA agrees to comply with and observe in all material
respects its obligations under the GENTA THIRD PARTY AGREEMENTS, including,
without limitation, its obligation to pay any royalties, sublicensing fees and
other amounts due thereunder. GENTA agrees to promptly provide AVENTIS with
copies of all correspondence relating to the GENTA THIRD PARTY AGREEMENTS which
may impact AVENTIS' rights under this AGREEMENT. GENTA agrees not to terminate,
amend, or otherwise modify or waive any of the terms or conditions of the GENTA
THIRD PARTY AGREEMENTS in any manner that would adversely affecting AVENTIS'
rights under this AGREEMENT without the prior written consent of AVENTIS.
17.2.4 The GENTA PATENT RIGHTS that GENTA owns or purports to own are
owned, as of the Effective Date, free from any material liens or restrictions,
and GENTA will
(*) Represents language that is redacted and subject to Confidential Treatment.
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not suffer or permit any material liens or restrictions to be imposed on such
GENTA PATENT RIGHTS without the prior written consent of AVENTIS, unless the
lien holder agrees to take such GENTA PATENT RIGHTS subject to AVENTIS' rights
therein.
17.2.5 GENTA has all rights necessary under the GENTA THIRD PARTY
AGREEMENTS to grant the rights and licenses granted to AVENTIS hereunder, and
GENTA has not previously granted to any THIRD PARTY any rights or licenses under
the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY that are inconsistent with the
rights and licenses granted to AVENTIS under this AGREEMENT.
17.2.6 As of the Effective Date, each GENTA THIRD PARTY AGREEMENT is
in full force and effect in accordance with its terms. As of the Effective Date,
GENTA is not in default or breach of any GENTA THIRD PARTY AGREEMENT, nor has it
received any notice of any defaults, breaches or violation thereunder. To the
best of GENTA's knowledge as of the Effective Date, no other party to any GENTA
THIRD PARTY AGREEMENT is in default or breach of such agreement. GENTA has
provided AVENTIS with copies of the GENTA THIRD PARTY AGREEMENTS, as amended (to
the extent that GENTA is a party to such amendment or its rights are affected
thereunder), that are true, correct and complete as of the Effective Date.
17.2.7 To the best of GENTA's knowledge, there is no claim or demand
of any person or entity pertaining to, or any proceeding which is pending or
threatened, that challenges the rights of GENTA in respect of any GENTA PATENT
RIGHTS or the GENTA TECHNOLOGY, that asserts the invalidity, misuse,
unregisterability or unenforceability of any of the GENTA PATENT RIGHTS or the
GENTA TECHNOLOGY, or that claims that any default exists under any license with
respect to the GENTA PATENT RIGHTS or the GENTA TECHNOLOGY to which GENTA is a
party.
17.2.8 As of the Effective Date, to the best of GENTA's knowledge,
neither GENTA, nor any officer, employee or agent of GENTA, has made an untrue
statement of a material fact to any REGULATORY AUTHORITY with respect to
COMPOUND or PRODUCT (whether in any submission to such REGULATORY AUTHORITY or
otherwise), or knowingly failed to disclose a material fact required to be
disclosed to any REGULATORY AUTHORITY with respect to COMPOUND or PRODUCT.
17.2.9 To the best of GENTA's knowledge, GENTA and its employees,
agents, clinical institutions and clinical investigators have complied with all
FDA statutory and regulatory requirements with respect to PRODUCT and COMPOUND.
17.2.10 GENTA has disclosed to AVENTIS any facts known to GENTA as of
the Effective Date that GENTA reasonably believes in good faith to be material
regarding: (i) preclinical and clinical study results and protocols for COMPOUND
and/or PRODUCT; (ii) any communications to and from FDA with respect to COMPOUND
and/or PRODUCT, including, but not limited to, IND and NDA submissions, FDA
minutes of meetings and telephone conferences; (iii) FDA requests for data and
studies on COMPOUND and/or PRODUCT; and (iv) adverse drug experiences and other
IND safety reports with respect to COMPOUND and/or PRODUCT.
(*) Represents language that is redacted and subject to Confidential Treatment.
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17.3 Disclaimer of Additional Warranties. GENTA AND AVENTIS EXPRESSLY
DISCLAIM ANY OTHER WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING,
WITHOUT LIMITATION, WITH RESPECT TO PRODUCT AND THE RESEARCH AND DEVELOPMENT
EFFORTS RELATING THERETO), INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES
OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.
17.4 Indemnification by AVENTIS. AVENTIS shall defend GENTA, its AFFILIATES
and their respective officers, directors, shareholders, employees, successors
and assigns (the "GENTA Indemnified Parties") from and against, and shall
indemnify and hold harmless the GENTA Indemnified Parties from and against any
and all LOSSES to the extent arising out of, any CLAIMS of THIRD PARTIES
alleging (i) AVENTIS' negligence or willful misconduct in exercising or
performing any of its rights or obligations under this AGREEMENT or the Global
Supply Agreement, (ii) a material breach by AVENTIS of any of its
representations, warranties or covenants under this AGREEMENT or the Global
Supply Agreement, and (iii) any activities (*).
17.5 Indemnification by GENTA. GENTA shall defend AVENTIS, its AFFILIATES
and their MARKETING DISTRIBUTORS, and their respective officers, directors,
shareholders, employees, successors and assigns (the "AVENTIS Indemnified
Parties") from and against, and shall indemnify and hold harmless the AVENTIS
Indemnified Parties from and against any and all LOSSES to the extent arising
out of, any CLAIMS of THIRD PARTIES alleging (i) GENTA's negligence or willful
misconduct in exercising or performing any of its rights or obligations under
this AGREEMENT or the Global Supply Agreement, (ii) a material breach by GENTA
of any of its representations, warranties or covenants under this AGREEMENT or
the Global Supply Agreement, (iii) the manufacture, use, marketing or sale of
COMPOUND or PRODUCT by GENTA following the term of this AGREEMENT, (iv) any
activities (*), (v) any breach by GENTA of its obligations (including,
without limitation, any payment obligations) under the GENTA THIRD PARTY
AGREEMENTS.
17.6 Procedure for Indemnification. The following provisions shall apply to
all CLAIMS of THIRD PARTIES covered by Section 17.4 or Section 17.5 above:
17.6.1 Notice. Each Party will notify promptly the other Party if it
becomes aware of a CLAIM for which indemnification may be sought under Section
17.4 or Section 17.5 above and will give such information with respect thereto
as the other Party shall reasonably request. If any proceeding (including any
governmental investigation) is instituted involving any Party regarding which
indemnity may be sought pursuant to Section 17.4 or Section 17.5 above, such
Party (the "Indemnified Party") shall not make any admission concerning such
CLAIM, but shall promptly notify the other Party (the "Indemnifying Party") in
writing and the Indemnifying Party and Indemnified Party shall meet to discuss
how to respond to such CLAIM. The Indemnifying Party shall not be obligated to
indemnify the Indemnified Party against any CLAIM to the extent any admission
made by the Indemnified Party or any failure by such Party
(*) Represents language that is redacted and subject to Confidential Treatment.
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to notify the Indemnifying Party of such CLAIM materially prejudices the defense
of such CLAIM.
17.6.2 Defense of Claims. If the Indemnifying Party elects to defend a
CLAIM pursuant to Section 17.6.1, it shall give notice to the Indemnified Party
within fifteen (15) days after the receipt of the notice from the Indemnified
Party of the potential indemnifiable CLAIM which involves (and continues to
involve) solely monetary damages; provided, that (a) the Indemnifying Party
expressly agrees in such notice that, as between the Indemnifying Party and the
Indemnified Party, the Indemnifying Party shall be solely obligated to satisfy
and discharge the CLAIM, subject to the terms, conditions and limitations of
this AGREEMENT, and (b) the Indemnifying Party makes reasonably adequate
provisions to ensure the Indemnified Party of the ability of the Indemnifying
Party to satisfy the full amount of any adverse monetary judgment that may
result such conditions (the "Litigation Conditions"). Subject to compliance with
the Litigation Conditions, the Indemnifying Party shall retain counsel
reasonably satisfactory to the Indemnified Party to represent the Indemnified
Party and shall pay the fees and expenses of such counsel related to such
proceeding. In any such proceeding, the Indemnified Party shall have the right
to retain its own counsel, but the fees and expenses of such counsel shall be at
the expense of the Indemnified Party unless: (a) the Indemnifying Party and the
Indemnified Party shall have mutually agreed to the retention of such counsel,
or (b) the named parties to any such proceeding (including any impleaded
parties) include both the Indemnifying Party and the Indemnified Party and
representation of both Parties by the same counsel would be inappropriate due to
actual or potential differing interests between them. All such fees and expenses
shall be reimbursed as they are incurred. If the Litigation Conditions are not
met within twenty (20) days after receipt of notice of the CLAIM, the
Indemnifying Party shall be bound by any reasonable defense or settlement made
by the Indemnified Party and shall reimburse the Indemnified Party for any and
all LOSSES of the Indemnified Party related to the defense or settlement of the
CLAIM. If the Litigation Conditions have been met, then the Indemnified Party
shall not settle any CLAIM for which it is seeking indemnification without the
prior consent of the Indemnifying Party, which consent shall not be unreasonably
withheld. The Indemnified Party shall, if requested by the Indemnifying Party,
cooperate in all reasonable respects in the defense of such CLAIM that is being
managed and controlled by the Indemnifying Party. The Indemnifying Party shall
not, without the written consent of the Indemnified Party, effect any settlement
of any pending or threatened proceeding in respect of which the Indemnified
Party is, or arising out of the same set of facts could have been, a Party and
indemnity could have been sought hereunder by the Indemnified Party, unless such
settlement includes an unconditional release of the Indemnified Party from all
liability on claims that are the subject matter of such proceeding.
17.6.3 Right to Counsel. Notwithstanding anything to the contrary
contained herein, an Indemnified Party shall be entitled to assume the defense
of any CLAIM with respect to the Indemnified Party, upon written notice to the
Indemnifying Party pursuant to this Section 17.6.3, in which case the
Indemnifying Party shall be relieved of liability under Section 17.4 or Section
17.5, as applicable, solely for such CLAIM.
17.7 Product Liability Claims.
17.7.1 Other than CLAIMS for which AVENTIS is obligated to indemnify
GENTA under Section 17.4 above, or for which GENTA is obligated to indemnify
AVENTIS
(*) Represents language that is redacted and subject to Confidential Treatment.
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under Section 17.5 above, the Parties shall share responsibility for all LOSSES
arising out of or resulting from any and all CLAIMS of THIRD PARTIES concerning
PRODUCT sold in the United States by AVENTIS or its AFFILIATES or their
MARKETING DISTRIBUTORS during the term of this AGREEMENT (and, if applicable,
during any Trailing Period) that involve death or bodily injury to any
individual, including, without limitation, any product liability actions
(collectively, "U.S. Product Liability Claims") as set forth in this Section
17.7.
17.7.2 Each Party shall give the other prompt written notice of any
U.S. Product Liability Claim, but the omission of such notice shall not relieve
either Party from its obligations under this Section 17.7, except to the extent
the other Party can establish actual prejudice and direct damages as a result
thereof. With respect to each U.S. Product Liability Claim, the Parties shall
determine by mutual agreement, within twenty (20) days following their receipt
of notice of the commencement of or assertion of such U.S. Product Liability
Claim (or such lesser period of time as may be required to properly respond to
such claim) which Party shall assume the lead role in the defense thereof.
Should the Parties be unable to mutually agree on who shall assume the lead role
in the defense of any U.S. Product Liability Claim, AVENTIS shall be entitled to
assume such role, and if AVENTIS declines or fails to diligently assume such
role, GENTA shall be entitled to assume such role.
17.7.3 The Party assuming the lead role in the defense of any U.S.
Product Liability Claim (the "Controlling Party") shall consult with the other
Party on all material aspects of the defense, including, without limitation,
settlement, of such claim, the other Party shall have a reasonable opportunity
to participate in decision-making with respect to the strategy of such defense,
and the Parties shall reasonably cooperate with each other in connection with
the implementation thereof. The non-defending Party shall also have the right to
participate in the defense of any U.S. Product Liability Claim utilizing
attorneys of its choice, at its own expense. In furtherance of the Parties'
cooperation, the Controlling Party will consult with the other Party regarding
strategic decisions, including, without limitation, the retention of counsel for
defense of any U.S. Product Liability Claim. The Controlling Party will
otherwise keep the other Party reasonably informed of the status and progress of
the defense and any settlement discussions concerning each U.S. Product
Liability Claim, and the Parties shall provide each other with all reasonably
requested assistance and will reasonably cooperate with each other in connection
therewith. Any settlement of a U.S. Product Liability Claim shall require mutual
agreement of the Parties, such agreement not to be unreasonably withheld.
17.7.4 The Parties shall share equally in all LOSSES arising out of or
resulting from any U.S. Product Liability Claim. The Parties shall establish
such procedures as are reasonably necessary to permit them to reconcile their
actual payments for such LOSSES with their percentage share of responsibility
for such LOSSES on a quarterly basis, within sixty (60) days following the end
of each CALENDAR QUARTER.
17.7.5 U.S. Product Liability Claims shall be governed exclusively by
this Section 17.7 and, except in accordance with this Section 17.7, neither
Party shall seek from the other Party any indemnity or other recovery on account
of any such claims; provided, however, that nothing in this Section 17.7 shall
limit either Party's liability to the other for damages on account of any breach
by such Party of its representations, warranties, covenants or agreements under
Section 17.1 or Section 17.2 above.
(*) Represents language that is redacted and subject to Confidential Treatment.
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17.8 Offset of Insurance Proceeds. Any indemnification hereunder shall be
made net of any insurance proceeds recovered by the indemnified person or
entity; provided, however, that if, following the payment to such person or
entity of any amount under this Section 17, such person or entity recovers any
insurance proceeds in respect of the claim for which such indemnification
payment was made, such person or entity shall promptly pay an amount equal to
the amount of such insurance proceeds (but not exceeding the amount of such
indemnification payment from the indemnifying Party) to the indemnifying Party.
17.9 Insurance. Each Party shall maintain, during the term of this
AGREEMENT, Commercial General Liability Insurance, (including Products
Liability, Contractual Liability, Bodily Injury, Property Damage and Personal
Injury) to cover its indemnification obligations under this Section 17, with
minimum limits of $10 million. During the term of this AGREEMENT, each Party
shall not permit such insurance to be reduced, expired or canceled without
reasonable prior written notice to the other Party. Upon request each Party
shall provide Certificates of Insurance to the other Party evidencing the
coverage specified herein. Except as expressly stated in Section 17.8 above, a
Party's liability to the other is in no way limited to the extent of the Party's
insurance coverage. In the event of duplicate coverage, the insurance policy of
the Party whose fault causes the need for reimbursement under an insurance
policy shall be primary and the other Party's excess and non-contributing.
Notwithstanding the foregoing, AVENTIS may satisfy its obligations under this
Section 17.9 through self-insurance to the same extent as required herein.
17.10 Limitation of Liability. EXCEPT FOR ANY WILLFUL BREACH BY EITHER
PARTY OF ITS REPRESENTATIONS, WARRANTIES, COVENANTS OR AGREEMENTS UNDER SECTION
17.1 OR SECTION 17.2 ABOVE, OR FOR DAMAGES ACTUALLY PAID BY A PARTY TO A THIRD
PARTY PURSUANT TO A THIRD-PARTY CLAIM, IN NO EVENT SHALL EITHER PARTY BE LIABLE
TO THE OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL,
INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION,
LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR
ITS AFFILIATES IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES. THIS LIMITATION SHALL SURVIVE ANY FAILURE OF THE
ESSENTIAL PURPOSE OF A LIMITED OR EXCLUSIVE REMEDY SET FORTH HEREIN.
17.11 No Guaranty of Success. Subject to each Party's express
representations, warranties, covenants and agreements set forth herein, neither
Party makes any guarantees to the other concerning the success or potential
success of the activities contemplated under this AGREEMENT.
18. GENERAL PROVISIONS.
18.1 Force Majeure. If the performance of any part of this AGREEMENT by
either Party is prevented, restricted, interfered with or delayed by reason of
any cause beyond the reasonable control of such Party, its AFFILIATES or their
respective suppliers or contractors that could not, with the exercise of
reasonable due diligence, have been avoided (a "Force Majeure"), the Party so
affected shall be excused from such performance to the extent of and for
(*) Represents language that is redacted and subject to Confidential Treatment.
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so long as such Force Majeure continues, provided that the affected Party
uses COMMERCIALLY REASONABLE EFFORTS to avoid or remove the causes of such Force
Majeure with the utmost dispatch and to continue its performance under this
AGREEMENT whenever such causes are removed. When such circumstances arise, the
affected Party shall provide the other Party with prompt notice thereof and
shall regularly update the other Party as to its efforts to remove the causes of
such Force Majeure until full performance under this AGREEMENT has resumed.
Parties shall discuss what, if any, modification of the terms of this AGREEMENT
may be required in order to arrive at an equitable solution in light of any
Force Majeure, and, (*), the other Party's payment obligations hereunder shall
be suspended to the extent and for so long as the Force Majeure prevents such
other Party from substantially receiving the benefit of its bargain hereunder.
18.2 Governing Law and Dispute Resolution. This AGREEMENT and any disputes
concerning its validity, construction, enforceability or performance shall be
governed by the laws of the State of New York without reference to conflict of
law principles. In the event of any dispute under this AGREEMENT, whether as to
validity, construction, enforceability or performance of this AGREEMENT or any
of its provisions or otherwise, both Parties shall use reasonable efforts to in
good faith endeavor to settle such dispute amicably between themselves. In the
event that either Party determines in good faith that the continuation of such
efforts is not likely to lead to a resolution of any such dispute (except for
those matters referred for resolution to the "Expert Panel" pursuant to Section
18.3), the Parties shall be free to pursue any rights or remedies available to
them at law, in equity or otherwise, subject to the express provisions of this
AGREEMENT.
18.3 Expert Panel. In the event of a dispute by the Parties (*) that cannot
be resolved as set forth therein, either Party may by written notice to the
other Party require the specific issue in dispute to be submitted to a panel of
experts ("Expert Panel") in accordance with this Section 18.3. Such notice shall
contain a statement of the issue forming the basis of the dispute and the
position of the moving Party as to the proper resolution of that issue. Within
fifteen (15) days after receipt of such notice, the responding Party shall
submit to the moving Party a statement of its conception of the specific issue
in question and of its position as to the proper resolution of that issue.
Within twenty (20) days of the responding Party's response, each Party shall
appoint to the Expert Panel an individual who has expertise in the biotechnology
industry and the specific matters at issue and who is not affiliated with such
Party, and give the other Party written notice thereof. Thereafter, the two (2)
appointed experts shall select a third expert within fifteen (15) days after
receipt from the Parties of a list of proposed experts having expertise in the
biotechnology industry and the specific matters at issue. Each expert shall
agree prior to his or her appointment to hear the dispute promptly and render a
decision as soon as practicable thereafter. The Expert Panel shall convene in
English in New York. The experts shall not amend this AGREEMENT, but shall seek
to fashion a remedy consistent with the Parties' intentions set forth in this
Agreement. The agreement of two (2) of the three (3) experts shall be sufficient
to render a decision, and the Parties shall abide by such decision.
18.4 Waiver of Breach. The failure of either Party at any time or times to
require performance of any provision hereof shall in no manner affect its rights
at a later time to enforce the same. No waiver by either Party of any condition
or term in any one or more instances shall
(*) Represents language that is redacted and subject to Confidential Treatment.
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be construed as a further or continuing waiver of such condition or term or of
another condition or term.
18.5 Severability. In the event any portion of this AGREEMENT shall be held
illegal, void or ineffective, the remaining portions hereof shall remain in full
force and effect and the Parties will in good faith endeavor to renegotiate the
terms and conditions of this AGREEMENT to resolve any inequities. If a Party
seeks to avoid a provision of this AGREEMENT by asserting that such provision is
invalid, illegal or otherwise unenforceable, the other Party shall have the
right to terminate this AGREEMENT for breach in accordance with the provisions
of Section 15.2 above.
18.6 Entire Agreement. This AGREEMENT, together with the Exhibits and
attachments hereto and the other agreements between the Parties referred to
herein, constitute the entire agreement between the Parties relating to the
subject matter hereof and thereof and supersede all previous writings and
understandings with respect to such subject matter. No terms or provisions of
this AGREEMENT shall be varied or modified by any prior or subsequent statement,
conduct or act of either of the Parties, except that the Parties may amend this
AGREEMENT by written instruments specifically referring to and executed in the
same manner as this AGREEMENT. The provisions of this AGREEMENT shall supersede
the provisions of the confidentiality/non-disclosure agreement previously
entered into by the Parties provided that information or materials deemed
"Confidential Information" under such agreement shall henceforth be treated as
"Confidential Information" under this AGREEMENT.
18.7 Notices. Any notice required or permitted under this AGREEMENT shall
be sent by overnight delivery using a reputable overnight delivery service,
postage pre-paid, to the following addresses of the Parties, or to such other
addresses as the Parties may from time to time provide by a notice given
hereunder:
AVENTIS
Aventis Pharmaceuticals Inc.
Vice President, Legal Corporate Development
000 Xxxxxxxx Xxxxxxxxx
Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxxx, Esq.
copies to:
Xxxxxx, Xxxxx & Bockius LLP
000 Xxxxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Attn: Xxxxx Xxxxxx, Esq.
(*) Represents language that is redacted and subject to Confidential Treatment.
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GENTA:
Genta Incorporated
0 Xxxxxxx Xxxxx
Xxxxxxxx Xxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Xx., M.D.
Chairman of the Board and Chief Executive Officer
Any notice required or permitted to be given concerning this AGREEMENT shall be
effective upon receipt by the Party to whom it is addressed.
18.8 (*).
18.8.1 (*).
18.8.2 (*).
(*) Represents language that is redacted and subject to Confidential Treatment.
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18.8.3 (*).
18.9 No Partnership or Joint Venture. Each Party shall bear its own costs
incurred in the performance of its obligations hereunder without charge or
expense to the other Party, except as expressly provided in this AGREEMENT.
Neither Party shall have any authority to bind or obligate the other Party to
this AGREEMENT for any sum or in any manner whatsoever, or to create or impose
any contractual or other liability on the other Party without the other Party's
prior approval. For all purposes, and notwithstanding any other provision of
this AGREEMENT to the contrary, each Party's legal relationship with the other
under this AGREEMENT shall be that of an independent contractor, and this
AGREEMENT shall not be deemed to establish a joint venture or partnership
between AVENTIS and GENTA.
18.10 No Third-Party Beneficiaries. None of the provisions of this
AGREEMENT shall be for the benefit of or enforceable by any THIRD PARTY,
including without limitation any creditor of either Party hereto. No such THIRD
PARTY shall obtain any right under any provision of this AGREEMENT or shall by
reasons of any such provision make any CLAIM in respect of any debt, liability
or obligation (or otherwise) against either Party hereto.
18.11 Non-Solicitation. During the term of this AGREEMENT and for two (2)
years thereafter, a Party may not actively solicit an employee of the other
Party to leave the employment of the other Party and accept employment with the
first Party. Active solicitation shall not be deemed to include general
advertisement not directed specifically to any employee or class of employees of
the other Party.
18.12 Specific Performance. Each of the Parties acknowledges and agrees
that the other Party would be damaged irreparably in the event any of the
provisions of this AGREEMENT are not performed in all material respects or
otherwise are breached. Accordingly, and notwithstanding anything herein to the
contrary, each of the Parties agree that the other Party shall be entitled to
injunctive relief to prevent breaches of the provisions of this AGREEMENT,
and/or to enforce specifically this AGREEMENT and the terms and provisions
hereof, in any action instituted in any court or tribunal having jurisdiction
over the Parties and the matter, without posting any bond or other security, and
that such injunctive relief shall be in addition to any other remedies to which
such Party may be entitled, at law or in equity.
18.13 Further Assurances. Each Party shall execute, acknowledge and deliver
such further instruments, and shall do all such other acts as may be necessary
or appropriate, in order to carry out the purposes and intent of this AGREEMENT.
18.14 Execution in Counterparts. This AGREEMENT may be executed in any
number of counterparts, each of which shall be deemed an original but all of
which together shall constitute one and the same instrument.
[Remainder of this page intentionally blank]
(*) Represents language that is redacted and subject to Confidential Treatment.
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IN WITNESS WHEREOF, GENTA and AVENTIS, by their duly authorized officers,
have executed this AGREEMENT as of the Effective Date.
GENTA INCORPORATED
By:_____________________________________
Name: Xxxxxxx X. Xxxxxxx, Xx., M.D.
Title: Chairman & Chief Executive
Officer
AVENTIS PHARMACEUTICALS INC.
By:_____________________________________
Name: Xxxxxx X. Belle
Title: President and Chief Executive
Officer
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 1.24
G3139
USAN Name (NN-70): Oblimersen Sodium
Manufacturer: Genta Incorporated
Therapeutic Claim: Treatment of cancer and rheumatological diseases
(an antisense oligonucleotide)
Chemical names:
deoxyribose, phosphorothioate, (tct-ccc-agc-gtg-cgc-cat) [5' -> 3']
DNA, d(P-thio)(T-C-T-C-C-C-A-G-C-G-T-G-C-G-C-C-A-T)
Code Designation: G3139
Molecular Formula, acid form: C H N O P S
172 221 62 91 17 17
Molecular Weight, acid form: 5684.59
Molecular Formula, sodium form: X X X X X X Xx
000 000 62 91 17 17 17
Molecular weight, sodium form: 6058.27
CAS Registry Number: 190977-41-4
WHO Number: 8267
Structural Formula:
The structure of the sodium-salt form of G3139 is provided on the following
page. The configuration of all ribofuranosyl groups is "D".
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EXHIBIT 1.24 continued
Structure of G3139 Sodium Salt
[GRAPHIC OMITTED]
17 Na+
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EXHIBIT 1.25
GENTA G3139 PATENT RIGHTS
(*)
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EXHIBIT 1.25 continued
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 1.47
PRODUCT TRADEMARK
PRODUCT TRADEMARK: GENASENSE
U.S. Application No. 76/036889, dated April 28, 2000 for "oligonucleotide
pharmaceutical preparations for the treatment of cancer and rheumatological
diseases." Date of publication is December 18, 2001.
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 4.1.3
PRELIMINARY DEVELOPMENT ACTIVITIES
The attached tables constitute the clinical trials that shall be conducted by
the Parties as part of the DEVELOPMENT PLAN. The DEVELOPMENT COSTS associated
with such trials as of the EFFECTIVE DATE of the AGREEMENT shall be shared by
the Parties pursuant to Section 4.4 (Cost Allocation).
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EXHIBIT 4.1.3 continued
Table 1: Current randomized multicenter trials
-----------------------------------------------------------------
Indication
Protocol Number Center Design
=================================================================
Melanoma Multicenter,
1st-line multinational Randomized
GM 301
-----------------------------------------------------------------
CLL Multicenter,
2nd-line multinational Randomized
GL 303
-----------------------------------------------------------------
Myeloma Multicenter,
2nd-line multinational Randomized
GMY 302
-----------------------------------------------------------------
Non-small cell lung cancer U.S. Multicenter Randomized
2nd-line
GN 304
-----------------------------------------------------------------
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EXHIBIT 4.1.3 continued
Table 2: New high-priority trials
---------------------------------------
Indication Design
---------------------------------------
Prostate (*)
(hormone-refractory)
---------------------------------------
Breast (*)
(*)
---------------------------------------
(*) (*)
---------------------------------------
Non small cell lung (*)
(*)
---------------------------------------
Colorectal (*)
(*)
---------------------------------------
Non-Hodgkin's lymphoma (*)
(*)
---------------------------------------
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 4.1.4
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 7.1
PRELIMINARY MARKETING OBJECTIVES AND ACTIVITIES
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 7.3
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 10.2.2
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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SCHEDULE 17.2
GENTA SCHEDULE OF EXCEPTIONS
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