EXECUTION COPY
EX-U.S. COMMERCIALIZATION AGREEMENT
between
GENTA INCORPORATED
and
GARLISTON LIMITED
TABLE OF CONTENTS
Page
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EX-U.S. COMMERCIALIZATION AGREEMENT
THIS EX-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 GARLISTON LIMITED, an
Irish limited company having a place of business at Xxxxxxxx Xxxxxxxx Xxxxxx,
Xxxxxx 00, Xxxxxxx ("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, for AVENTIS to
commercialize products containing or comprising such compound outside of the
United States on the terms and conditions set forth below.
C. Contemporaneously with this AGREEMENT, AVENTIS PHARMACEUTICALS INC
("AVENTIS US") and GENTA have entered into a U.S. Commercialization Agreement
(the "U.S. Commercialization Agreement") under which AVENTIS US will develop
such products for regulatory approval outside of the United States, and AVENTIS,
AVENTIS US and GENTA have entered into a Global Supply Agreement (the "Global
Supply Agreement") under which GENTA will supply AVENTIS and AVENTIS US 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 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 "ALLIANCE MANAGEMENT COMMITTEE" shall have the meaning ascribed to such
term in the U.S. Commercialization Agreement.
1.3 "ANNUAL NET SALES" shall mean the total NET SALES of PRODUCT for a
particular CALENDAR YEAR.
1.4 "ANNUAL ROW NET SALES" shall mean the total ROW NET SALES of PRODUCT
for a particular CALENDAR YEAR.
1.5 (*)
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 "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.
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1.12 "COMPOUND" shall mean (i) G3139; and (ii) any OTHER COMPOUND that the
ALLIANCE MANAGEMENT COMMITTEE selects for co-development and commercialization
under the U.S. Commercialization Agreement.
1.13 "COVERING", "COVER" or "COVERED" 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.
1.14 "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).
1.15 "FDA" shall mean the United States Food and Drug Administration and
any successor thereto.
1.16 "FIELD" shall mean all human therapeutic uses.
1.17 "FIRST COMMERCIAL SALE" shall mean the first bona fide commercial sale
of PRODUCT (after MAA APPROVAL, if necessary) to a THIRD PARTY in a country by
or under authority of AVENTIS, its AFFILIATES or MARKETING DISTRIBUTORS.
1.18 (*)
1.19 "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 1.19, which is also known as oblimerosen sodium.
1.20 "GENTA G3139 PATENT RIGHTS" shall mean those PATENT RIGHTS listed in
Exhibit 1.20 (*).
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1.21 "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.
1.22 "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.
1.23 "GENTA THIRD PARTY AGREEMENTS" shall mean: (*).
1.24 "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.
1.25 "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).
1.26 "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.
1.27 "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
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indication(s) for which approval is sought, including, if applicable, approval
of pricing or reimbursement.
1.28 "MAJOR COUNTRY" shall mean (*).
1.29 "MAJOR EUROPEAN COUNTRY" shall mean:(*).
1.30 "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.
1.31 "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.
1.32 "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.
1.33 "OTHER COMPOUND" shall mean (*).
1.34 "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.
1.35 "PATENT RIGHTS" shall mean any patents, patent applications,
certificates of invention, or applications for certificates of invention and any
supplemental protection
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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.
1.36 "PRODUCT" shall mean any pharmaceutical composition containing
COMPOUND (i.e., COMPOUND alone or as incorporated into any formulation or
delivery system).
1.37 "PRODUCT TRADEMARK" shall mean the trademark identified in Exhibit
1.37 attached hereto, or such other trademark, symbol, logo and/or trade dress
as AVENTIS shall adopt for PRODUCT in the ROW.
1.38 "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.
1.39 "ROW" shall mean the entire TERRITORY other than the United States.
1.40 "ROW NET SALES" shall mean NET SALES of PRODUCT in the ROW; provided,
however, that "ROW NET SALES" shall exclude NET SALES of PRODUCT in any country
once royalties are no longer due and owing on account of NET SALES of PRODUCT in
such country under Section 7.1.1(a) or 7.1.1(b) below.
1.41 "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.
1.42 "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.
1.43 "TERRITORY" shall mean all countries of the world.
1.44 "THIRD PARTY(IES)" shall mean any party other than AVENTIS, GENTA and
their AFFILIATES.
1.45 "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
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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 ROW 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 necessary for them to exercise their rights and
perform their obligations as expressly set forth in this AGREEMENT, the 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 a
MAJOR EUROPEAN COUNTRY, 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 Conflict with Certain Existing Agreements.
2.2.1 Notwithstanding anything to the contrary in this AGREEMENT, the
rights and licenses granted by GENTA to AVENTIS (and its AFFILIATES and
MARKETING 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).
2.2.2 Nothing in this Section 2.2 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 15.1 or Section 15.2 below.
2.3 Non-Compete. (*)
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(*)
2.4 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 in 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 and PRODUCT.
3. REGULATORY MATTERS.
3.1 Recalls and Other Corrective Action.
3.1.1 International. AVENTIS shall make all final decisions with
respect to any recall, market withdrawal or any other corrective action related
to PRODUCT in the ROW, and AVENTIS shall undertake such actions in a manner
designed to minimize any harm to the marketability of PRODUCT or the reputation
of the Parties. Before making any such decision, AVENTIS shall notify and
consult with GENTA and shall consider in good faith any comments or suggestions
of GENTA. AVENTIS shall keep GENTA fully informed with respect to the status of
any such actions. At AVENTIS' request, GENTA shall provide reasonable assistance
to AVENTIS in conducting such recall, market withdrawal or other corrective
action, including, without limitation, providing all of GENTA's pertinent
records that AVENTIS may reasonably request to assist in effecting such action.
3.1.2 Cost of Recalls or Other Corrective Actions. Except as expressly
otherwise provided below in this Section 3.1, AVENTIS shall bear all costs of a
recall, marketing withdrawal or other corrective action with respect to PRODUCT
in the ROW, including the
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actual cost AVENTIS paid for the manufacture and supply of such PRODUCT.
Notwithstanding the foregoing, GENTA shall bear any and all costs of a recall,
market withdrawal or other corrective action with respect to PRODUCT in the ROW,
including the actual cost AVENTIS paid for the manufacture and supply of such
PRODUCT, to the extent such recall, market withdrawal or other corrective action
is attributable predominantly to the fault of GENTA and results from: (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. 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.
3.2 Promotional Materials. AVENTIS shall be solely responsible for all
promotional materials for PRODUCT in the ROW, and for all interactions with
REGULATORY AUTHORITIES regarding approval of all such promotional materials.
4. EX-U.S. COMMERCIALIZATION AND PROMOTION.
4.1 Commercialization by AVENTIS.
4.1.1 General. AVENTIS shall be solely responsible for the prelaunch,
launch, promotion and sale of PRODUCT in the ROW.
4.1.2 Periodic Updates. No less frequently than once each CALENDAR
QUARTER, AVENTIS shall update the ALLIANCE MANAGEMENT COMMITTEE on AVENTIS'
efforts to commercialize PRODUCT in the ROW. Without limiting the foregoing,
AVENTIS shall provide the ALLIANCE MANAGEMENT COMMITTEE with such written
reports as its senior management committees receive regarding such
commercialization efforts.
4.2 Sales Rep Performance. AVENTIS will use COMMERCIALLY REASONABLE EFFORTS
to ensure that its sales force is adequately trained with respect to PRODUCT.
4.3 Booking Sales. During the term of this AGREEMENT, AVENTIS will book all
NET SALES for PRODUCT in each country of the ROW.
4.4 Monthly Sales Reports. AVENTIS shall provide GENTA with unaudited
monthly sales reports of NET SALES in the ROW to the extent the requisite data
is centrally collected within AVENTIS.
5. DILIGENCE.
5.1 Commercially Reasonable Efforts. Without limiting AVENTIS' obligations
under this AGREEMENT, AVENTIS shall use COMMERCIALLY REASONABLE EFFORTS
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to commercialize COMPOUND (including any OTHER COMPOUND that the Parties add to
the definition of COMPOUND) and PRODUCT in the ROW, including (a) launching
PRODUCT in each MAJOR COUNTRY of the ROW for each approved indication within a
reasonable period of time after appropriate MAA APPROVAL has been obtained for
such indication, and (b) after the FIRST COMMERCIAL SALE of PRODUCT in a MAJOR
COUNTRY of the ROW for a particular indication, to promoting sales of such
PRODUCT in such country.
5.2 Assistance. GENTA shall use COMMERCIALLY REASONABLE EFFORTS to assist
AVENTIS in achieving the goals specified in Section 5.1, subject to the
remaining provisions of this AGREEMENT and the U.S. Commercialization Agreement.
6. PRODUCT SUPPLY AND DISTRIBUTION.
6.1 Global Supply Agreement. Simultaneously with their execution of this
AGREEMENT, the Parties and AVENTIS US are executing the Global Supply Agreement.
Under the Global Supply Agreement, GENTA will supply AVENTIS and AVENTIS US 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.
7. REVENUE SHARING.
7.1 Payment. AVENTIS shall pay to GENTA the following amounts during the
term of this AGREEMENT:
7.1.1 (*)
(a) (*)
(i) (*)
(ii) (*)
(b) (*)
(i) (*)
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(ii) (*)
(c)(*)
7.1.2 Free Product. AVENTIS may use and distribute reasonable
quantities of PRODUCT in the ROW 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 7.1 on account of any distribution or use of
Free Product.
7.1.3 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 ROW NET SALES for such CALENDAR
QUARTER and the estimated amounts due to GENTA under this Section 7.1 on account
thereof. Within forty-five (40) days following the end of each CALENDAR QUARTER,
AVENTIS shall provide GENTA a final report reasonably detailing AVENTIS'
calculation of ROW NET SALES for such CALENDAR QUARTER and the amounts due to
GENTA under this Section 7.1 on account thereof. Payment of amounts due to GENTA
under this Section 7.1 shall be made in accordance with the provisions of
Section 9.3 below.
7.2 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
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AGREEMENTS by reason of the activities contemplated under this AGREEMENT, the
U.S. Commercialization Agreement, or the Global Supply Agreement.
7.3 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.
8. INTENTIONALLY OMITTED.
9. PAYMENTS; REPORTING; BOOKS AND RECORDS.
9.1 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 9.1 shall in no way limit any other remedies available to the
Parties.
9.2 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:
9.2.1 With respect to sales of PRODUCT made in currencies other than
U.S. Dollars, NET SALES for purposes of Section 7.1 will be converted to U.S.
Dollars using the arithmetic average of the "spot rates" on the last business
day of each month of the CALENDAR QUARTER in which the NET SALES were made. 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, shall be used as the source of "spot rates" to calculate the
average as defined in the preceding sentence.
9.3 Timing of Payments. Within five (5) business days following the date on
which the report under Section 7.1.3 above is due to GENTA for a given CALENDAR
QUARTER, AVENTIS shall pay to GENTA the amount due under Section 7.1 above for
such CALENDAR QUARTER.
9.4 Taxes. AVENTIS shall bear and pay, and shall indemnify GENTA against,
all applicable non-US taxes, value-added or sales tax, duties or levies and
assessments, howsoever designated or computed that are required to be paid or
withheld by AVENTIS on the payments due under this AGREEMENT. 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 anything in this
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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.
9.5 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 7.1). 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 9.5 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 9.1 above.
The Parties will endeavor to minimize disruption of the audited Party's normal
business activities to the extent reasonably practicable.
10. CONFIDENTIALITY.
10.1 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 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 10 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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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.
10.2 Exceptions. The confidentiality obligations in this Section 10 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 use
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.
10.3 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.
10.4 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, 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.
(*) Represents language that is redacted and subject to Confidential Treatment.
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11. INTELLECTUAL PROPERTY.
11.1 Proprietary Rights, Inventions.
11.1.1 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.
11.1.2 Upon the termination of this AGREEMENT (but not its expiration)
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 ROW,
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.
11.2 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.
11.3 Patent Filing, Prosecution and Maintenance.
11.3.1 Performance by GENTA. GENTA shall file, prosecute and maintain,
or to require its licensors to file, prosecute and maintain, all patent
applications and patents included in the GENTA PATENT RIGHTS, and to 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,
(*) Represents language that is redacted and subject to Confidential Treatment.
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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.
11.3.2 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.
11.3.3 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.
11.4 ROW Patent Infringement Claims.
11.4.1 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 any country of the ROW, 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 any country of the ROW, or upon the
filing of an abbreviated new drug application related to related to COMPOUND or
PRODUCT (each, a "ROW Patent Infringement Claim"). With respect to each ROW
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 ROW 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 unable to
mutually agree on who shall assume the lead role in the defense of any ROW
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.
11.4.2 The Party assuming the lead role in the defense of any ROW
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
(*) Represents language that is redacted and subject to Confidential Treatment.
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the defense of any ROW 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 ROW 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 ROW 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. (*).
11.4.3 The Parties shall share equally in all LOSSES arising out of or
resulting from any ROW 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 ROW 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.
11.4.4 ROW Patent Infringement Claims shall be governed exclusively by
this Section 11.4 and, except in accordance with this Section 11.4, 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 11.4 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 15.1 or Section 15.2 below.
11.5 License of Third Party Rights.
11.5.1 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 a country of the ROW, 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 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 such country on terms reasonably acceptable to both Parties, such
acceptance not to be unreasonably withheld or delayed. (*).
(*) Represents language that is redacted and subject to Confidential Treatment.
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11.5.2 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 11.5.1 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 a country of the ROW, 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. (*).
11.5.3 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 11.5.1 or 11.5.2 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
(*); and
11.5.4 Nothing in this Section 11.5 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 15.1 or Section 15.2 below.
11.6 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. 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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TECHNOLOGY shall not be inconsistent with the rights granted to AVENTIS
hereunder or under the U.S. Commercialization Agreement or the Global Supply
Agreement.
11.7 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.
11.8 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.
11.9 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 11 with respect to the filing, prosecution,
maintenance and/or enforcement of any of the GENTA PATENT RIGHTS, AVENTIS'
rights under this Section 11 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 11.
12. TRADEMARKS AND COPYRIGHTS.
12.1 Display. All packaging materials, package inserts, labels and
marketing, sales, advertising and promotional materials relating to PRODUCT
distributed in the ROW shall display the PRODUCT TRADEMARK and the trade
name/xxxx and/or logo of AVENTIS, in a form and style and with a placement
determined solely by AVENTIS, and will include on its packaging a mutually
agreed-upon reference to the TECHNOLOGY and PATENT RIGHTS licensed by GENTA
hereunder. The appearance of the PRODUCT TRADEMARK and AVENTIS' trademarks,
trade dress, style of packaging and the like with respect to PRODUCT shall be
determined by AVENTIS in is sole discretion, subject to the remainder of this
Section 12.
12.2 Ownership. GENTA acknowledges that AVENTIS owns all rights, title and
interests in and to the PRODUCT TRADEMARK in the ROW and that nothing in this
AGREEMENT grants GENTA or any persons or entity any rights, title or interest
therein, except as set forth in Section 14.8. GENTA and its AFFILIATES shall not
use, attempt to register, or register, as a trade/service xxxx, corporate name,
trade name or domain name, the PRODUCT TRADEMARK in the ROW or any other trade
names/marks and/or logos of AVENTIS, or assist any THIRD PARTY in doing so,
except as explicitly agreed to in writing by AVENTIS or in the U.S.
Commercialization Agreement. GENTA acknowledges that any use of the PRODUCT
TRADEMARK in the ROW, and any goodwill associated with such use, shall vest in
and inure to the benefit of AVENTIS.
(*) Represents language that is redacted and subject to Confidential Treatment.
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12.3 Registration. AVENTIS shall, in its discretion, file, register and
maintain appropriate registrations for the PRODUCT TRADEMARK for use on and in
connection with the marketing, sale, advertising and/or promotion of PRODUCT in
the ROW. GENTA shall not register or attempt to register the PRODUCT TRADEMARK
or any other trade names/marks and/or logos of AVENTIS, or any confusingly
similar variations thereof, in any country in the ROW. GENTA and its AFFILIATES
shall not to contest the validity of the PRODUCT TRADEMARK in the ROW, or
AVENTIS' rights therein, directly or indirectly, or assist any THIRD PARTY in
doing so.
12.4 Competing Marks. AVENTIS shall not market, promote, sell and/or
distribute in the ROW, or authorize or permit another to market, promote, sell
and/or distribute in the ROW, any product other than PRODUCT under PRODUCT
TRADEMARK or any confusingly similar trade names/marks and/or logos.
12.5 Enforcement. AVENTIS reserves the right to determine, in its sole
discretion, whether to and to what extent to institute, prosecute or defend any
actions or proceedings involving or affecting any rights relating to the PRODUCT
TRADEMARK in the ROW. Upon AVENTIS' reasonable request, GENTA shall cooperate
with and assist AVENTIS in any of AVENTIS' enforcement efforts with respect to
the PRODUCT TRADEMARK in the ROW. AVENTIS shall retain all money damages, if
any, recovered in connection with such action.
12.6 Avoidance of Confusion. In the event that actual confusion should
arise, or either Party reasonably believes that a likelihood of confusion may
arise, in connection with AVENTIS' use of the PRODUCT TRADEMARK in the ROW, the
Parties will fully cooperate in an effort to eliminate such confusion and to
avoid the possibility of such a likelihood of confusion.
12.7 Non-Assignment. During the term of this AGREEMENT and, if applicable,
any Trailing Period, AVENTIS 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.
12.8 Copyrights. AVENTIS shall solely own the copyrights in all packaging,
labels, marketing, sales, advertising or promotional materials relating to the
PRODUCT in the ROW ("ROW Copyrighted Works"). GENTA shall cooperate with AVENTIS
to enforce and defend, including but not limited to registering with the
applicable copyright offices in the ROW, AVENTIS' interest in the ROW
Copyrighted Works, and shall take no action to this end without the consent of
AVENTIS.
13. TERM AND TERMINATION.
13.1 Expiration. Unless earlier terminated pursuant to this Section, this
AGREEMENT shall continue in full force and effect, on a country-by-country basis
throughout the ROW, until no further royalties are payable to GENTA hereunder on
account of NET SALES in such country.
(*) Represents language that is redacted and subject to Confidential Treatment.
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13.2 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 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 13.2 shall preclude AVENTIS from
terminating this AGREEMENT as otherwise expressly permitted hereunder.
13.3 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, (*).
13.4 Cross-Default and Termination. Any material breach or default
permitting a Party to terminate this AGREEMENT under Section 13.2 above shall
also constitute a breach or default permitting, but not requiring, such Party to
terminate the U.S. Commercialization Agreement for a material breach or default
under Section 15.2 thereof. A Party seeking to terminate the 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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Section 13.2 above, or such Party shall have waived its rights to terminate the
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 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 13.2 above shall result in the automatic termination of the U.S.
Commercialization Agreement (although such termination of the U.S.
Commercialization Agreement shall not be deemed a termination for material
breach or default under Section 15.2 thereof). Moreover, termination of both
this AGREEMENT and the U.S. Commercialization Agreement shall result in the
automatic termination of the Global Supply Agreement.
14. RIGHTS AND DUTIES UPON TERMINATION.
14.1 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.
14.2 Sale of Remaining Inventory. Upon termination of this AGREEMENT (but
not its expiration), 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 ROW. 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.
14.3 Return of Materials. Within sixty (60) days following the Trailing
Period after any termination of this AGREEMENT (but not its expiration), 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.
14.4 Cooperation and Transition. During the six (6) month period following
AVENTIS' written notice of termination under Section 13.3 above, or, if this
AGREEMENT is terminated for any other reason (but not upon any expiration of
this AGREEMENT), 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 and regulatory
activities being performed by AVENTIS hereunder with respect to PRODUCT, and of
the activities being performed by AVENTIS
(*) Represents language that is redacted and subject to Confidential Treatment.
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hereunder with respect to commercialization of PRODUCT in the ROW, to GENTA or
its designee(s).
14.5 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: 3.1 (with respect to PRODUCT
purchased and/or sold by AVENTIS during the term of this AGREEMENT or any
applicable Trailing Period), 9.4, 9.5, 10.1-10.4, 11.1.1, 11.1.2, 14.1-14.8,
15.3-15.8, 15.10, 16.2-16.6, and 16.8-16.13; and, in addition, to the extent
that any PRODUCT is sold during the Trailing Period defined in Section 14.2,
Sections 7.1-7.3, 9.1-9.5, and 12.1-12.8. Moreover, upon any expiration (but not
termination) of this AGREEMENT with respect to a particular country, AVENTIS'
license rights under Section 2 above with respect to such country shall become
fully paid-up, perpetual and irrevocable, to the extent permitted under any
applicable GENTA THIRD PARTY license agreements, and provided that AVENTIS shall
reimburse GENTA for the amount of royalties, licensing fees, sublicensing fees
and other amounts required to be paid by GENTA to THIRD PARITES (including
without limitation under the GENTA THIRD PARTY AGREEMENTS) on account of the
continued use, manufacture, sale or exploitation of PRODUCT or COMPOUND by
AVENTIS or its AFFILIATES or MARKETING DISTRIBUTORS, or the continued
manufacture or supply by GENTA or its AFFILIATES or subcontractors of PRODUCT or
COMPOUND for AVENTIS, its AFFILIATES or MARKETING DISTRIBUTORS, where
"continued" means after the date of such expiration.
14.6 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.
14.7 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 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.
14.8 Rights on Early Termination. Upon the termination (but not the
expiration) of this AGREEMENT for any reason other than a material breach by
GENTA under Section 13.2,
(*) Represents language that is redacted and subject to Confidential Treatment.
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AVENTIS: (a) shall assign, and hereby assigns, to GENTA all of its right, title
and interest in and to (i) the PRODUCT TRADEMARK in the ROW and any and all
other PRODUCT-specific trademarks registered by AVENTIS in the ROW; (ii) the ROW
Copyrighted Works that are specific to PRODUCT; (b) shall provide GENTA copies
of all reasonably necessary DATA relating to PRODUCT then being sold under this
AGREEMENT; and (c) shall assign to GENTA or its designee(s), and permit GENTA or
its designee(s) to reference, such of AVENTIS' filings, authorizations and the
like that are necessary for GENTA or its designee(s) to continue such sales
activities.
15. WARRANTIES AND REPRESENTATIONS, INDEMNIFICATION AND INSURANCE.
15.1 General Representations. Each Party hereby represents and warrants to
the other Party as follows:
15.1.1 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.
15.1.2 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.
15.1.3 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.
15.1.4 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.
15.1.5 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.
(*) Represents language that is redacted and subject to Confidential Treatment.
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15.2 GENTA Additional Representations, Warranties and Covenants. GENTA
hereby represents, warrants, covenants and agrees, except as set forth in detail
in Schedule 15.2 (which schedule shall clearly indicate the subsection of this
Section 15.2 to which an exception is being made), as follows:
15.2.1 Exhibit 1.20, 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.
15.2.2 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.
15.2.3 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.
15.2.4 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 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.
15.2.5 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.
15.2.6 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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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.
15.2.7 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.
15.2.8 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.
15.2.9 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.
15.2.10 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.
15.3 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.
15.4 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, or (ii) a material breach by AVENTIS of any of its
(*) Represents language that is redacted and subject to Confidential Treatment.
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representations, warranties or covenants under this AGREEMENT or the Global
Supply Agreement.
15.5 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, or (iii) any breach by GENTA of its obligations
(including, without limitation, any payment obligations) under the GENTA THIRD
PARTY AGREEMENTS.
15.6 Procedure for Indemnification. The following provisions shall apply to
all CLAIMS of THIRD PARTIES covered by Section 15.4 or Section 15.5 above:
15.6.1 Notice. Each Party will notify promptly the other Party if it
becomes aware of a CLAIM for which indemnification may be sought under Section
15.4 or Section 15.5 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 15.4 or Section 15.5 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 to notify the
Indemnifying Party of such CLAIM materially prejudices the defense of such
CLAIM.
15.6.2 Defense of Claims. If the Indemnifying Party elects to defend a
CLAIM pursuant to Section 15.6.1, 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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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 damages, fines, fees, penalties, judgments, deficiencies, losses and
expenses (including without limitation interest, court costs, reasonable fees of
attorneys, accountants and other experts or other expenses of litigation or
other proceedings or of any claim, default or assessment) 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.
15.6.3 Right to Counsel. Notwithstanding anything to the contrary
contained herein, an Indemnified Party shall be entitled to assume the defense
of CLAIM with respect to the Indemnified Party, upon written notice to the
Indemnifying Party pursuant to this Section 15.6.3, in which case the
Indemnifying Party shall be relieved of liability under Section 15.4 or Section
15.5, as applicable, solely for such CLAIM.
15.7 Product Liability Claims.
15.7.1 Other than CLAIMS for which AVENTIS is obligated to indemnify
GENTA under Section 15.4 above, or for which GENTA is obligated to indemnify
AVENTIS under Section 15.5 above, AVENTIS shall be responsible for all LOSSES
arising out of or resulting from any and all CLAIMS of THIRD PARTIES concerning
PRODUCT sold in the ROW by AVENTIS, its AFFILIATES or their MARKETING
DISTRIBUTORS that involve death or bodily injury to any individual, including,
without limitation, any product liability actions (collectively, "ROW Product
Liability Claims") as set forth in this Section 15.7.
15.7.2 Each Party shall give the other prompt written notice of any
ROW Product Liability Claim, but the omission of such notice shall not relieve
either Party from its obligations under this Section 15.7, except to the extent
the other Party can establish actual prejudice and direct damages as a result
thereof. With respect to each ROW Product Liability Claim, AVENTIS shall be
solely responsible for the defense thereof.
15.7.3 AVENTIS shall consult with GENTA on all material aspects of the
defense, including, without limitation, settlement, of such claim, and GENTA
shall reasonably cooperate with AVENTIS in connection with the implementation
thereof. GENTA shall have the right to participate in the defense of any ROW
Product Liability Claim utilizing attorneys of its choice, at its own expense.
AVENTIS will otherwise keep GENTA reasonably informed of
(*) Represents language that is redacted and subject to Confidential Treatment.
- 28 -
the status and progress of the defense and any settlement discussions concerning
each ROW Product Liability Claim and GENTA shall provide AVENTIS with all
reasonably requested assistance and will reasonably cooperate with AVENTIS in
connection therewith. Any settlement of a ROW Product Liability Claim shall
require AVENTIS' written consent.
15.7.4 The Parties shall establish such procedures as are reasonably
necessary to permit AVENTIS to reconcile its payment to GENTA for GENTA's actual
payments for such LOSSES, if any, within sixty (60) days following the end of
each CALENDAR QUARTER.
15.7.5 ROW Product Liability Claims shall be governed exclusively by
this Section 15.7 and, except in accordance with this Section 15.7, 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 15.7 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 15.1 or Section 15.2 above.
15.8 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 15, 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.
15.9 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 15, 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. Upon request each party shall provide
Certificates of Insurance to the other party evidencing the coverage specified
herein. Except as expressly stated in Section 15.8 above, 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 15.9 through
self-insurance to the same extent as required herein.
15.10 Limitation of Liability. EXCEPT FOR ANY WILLFUL BREACH BY EITHER
PARTY OF ITS REPRESENTATIONS, WARRANTIES, COVENANTS OR AGREEMENTS UNDER SECTION
15.1 OR SECTION 15.2 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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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.
15.11 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.
16. GENERAL PROVISIONS.
16.1 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 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.
16.2 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, 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.
16.3 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 be construed as a further or
continuing waiver of such condition or term or of another condition or term.
16.4 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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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 13.2 above.
16.5 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.
16.6 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
Xxxx-Xxxxxxxx Fort and Xxxxxxxx Xxxxx
c/o Aventis
Espace Europeen de l'Entreprise
00 xxxxxx xx x'Xxxxxx
00000 XXXXXXXXXXXX, XXXXXX
copies to:
Aventis Pharmaceuticals Inc.
Vice President, Legal Corporate Development
000 Xxxxxxxx Xxxxxxxxx
Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxxx, Esq.
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.
16.7 (*).
16.8 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.
16.9 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.
16.10 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
(*) Represents language that is redacted and subject to Confidential Treatment.
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shall not be deemed to include general advertisement not directed specifically
to any employee or class of employees of the other Party.
16.11 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.
16.12 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.
16.13 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
GARLISTON LIMITED
By:_____________________________________
Name:
Title:
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 1.19
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".
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 1.19 continued
Structure of G3139 Sodium Salt
[GRAPHIC OMITTED]
17 Na+
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 1.20
GENTA G3139 PATENT RIGHTS
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 1.20 continued
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 1.37
PRODUCT TRADEMARK
PRODUCT TRADEMARK: GENASENSE
1. Canadian Application No. 1112992, dated August 16, 2001, for "pharmaceutical
preparations for the treatment of cancer and rheumatological diseases."
2. European Community Application No. 002379709, dated September 17, 2001, for
"pharmaceutical preparations for the treatment of cancer and rheumatological
diseases."
3. Japanese Reg. No. 0000000, dated August 31, 2001, for "pharmaceutical
preparations."
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 7.1.1
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
- 40 -
SCHEDULE 15.2
GENTA SCHEDULE OF EXCEPTIONS
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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