EXECUTION COPY
GLOBAL SUPPLY AGREEMENT
among
GENTA INCORPORATED
and
AVENTIS PHARMACEUTICALS INC.
and
GARLISTON LIMITED
TABLE OF CONTENTS
Page
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(*) Represents language that is redacted and subject to Confidential Treatment.
GLOBAL SUPPLY AGREEMENT
THIS GLOBAL SUPPLY AGREEMENT (hereinafter, this "AGREEMENT"), made as of
the 26th day of April, 2002 (the "Effective Date"), among GENTA INCORPORATED, a
Delaware corporation having a principal place of business at 0 Xxxxxxx Xxxxx,
Xxxxxxxx Xxxxxxx, XX 00000 ("GENTA"), AVENTIS PHARMACEUTICALS INC., a Delaware
corporation having a place of business at 000 Xxxxxxxx Xxxxxxxxx, Xxxxxxxxxxx,
Xxx Xxxxxx 00000-0000 ("AVENTIS US"), and GARLISTON LIMITED, an Irish limited
company having a place of business at Xxxxxxxx Xxxxxxxx Xxxxxx, Xxxxxx 00,
Xxxxxxx ("AVENTIS IRELAND") ("AVENTIS IRELAND"; collectively with AVENTIS US,
"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. Contemporaneously with this Agreement, AVENTIS US and GENTA have entered
into a U.S. Commercialization Agreement under which AVENTIS US will
commercialize products containing or comprising such compound in the United
States (the "U.S. Commercialization Agreement"), and AVENTIS IRELAND and GENTA
have entered into an Ex-U.S. Commercialization Agreement under which AVENTIS
IRELAND will commercialize products containing or comprising such compound
outside of the United States (the "Ex-U.S. Commercialization Agreement";
together with the U.S. Commercialization Agreement, the "Commercialization
Agreements").
C. AVENTIS and GENTA desire that GENTA supply AVENTIS with such products,
in finished form, on the terms and conditions set forth below.
AGREEMENT
1. DEFINITIONS.
1.1 "ACTIVE INGREDIENT" or "API" shall mean (i) G3139 (also known as
oblimerosen sodium), that certain all-phosphorothioate oligonucleotide
consisting of 18 modified nucleic acid bases with the sequence and chemical
structure set forth in Exhibit 1.1; and (ii) such other active pharmaceutical
compounds that are included in the definition of "COMPOUND" under the
Commercialization Agreements unless, at the time of such inclusion, AVENTIS has
the legal right to obtain such COMPOUND from THIRD PARTIES other than the
co-exclusive licensees under the GENTA THIRD PARTY AGREEMENT with (*).
1.2 "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
(*) Represents language that is redacted and subject to Confidential Treatment.
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.
1.3 "API PRODUCTION" shall mean production, storage and transportation of
API from the time of receipt of the KEY RAW MATERIALS through the time API is
shipped to the person or entity responsible for FORMULATION AND FILLING.
1.4 "BULK DRUG PRODUCT" shall mean PRODUCT prior to being in its finished,
labeled and packaged form, as released for FINAL PACKAGING.
1.5 "CALENDAR MONTH" shall mean each calendar month during the term of this
AGREEMENT.
1.6 "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.
1.7 "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.
1.8 "COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to a Party,
the efforts and resources which would be used (including without limitation the
promptness in which such efforts and resources would be applied) by such Party,
consistent with generally-accepted industry standards, with regard to the
diligent development, manufacture and commercialization of pharmaceutical
products of similar market and profit potential at a similar stage in
development or product life. The term "COMMERCIALLY REASONABLE" shall have a
corresponding meaning.
1.9 "CURRENT GOOD MANUFACTURING PRACTICES" or the letters "GMP" or "cGMP"
shall mean current good manufacturing practice and standards as provided for
(and as amended from time to time) in European Community Directive 91/356/EEC
(Principles and guidelines of good manufacturing practice for medicinal
products) and in the Current Good Manufacturing Practice Regulations of the U.S.
Code of Federal Regulations Title 21 (21 C.F.R. xx.xx. 210 and 211) in relation
to the production of pharmaceutical intermediates and active pharmaceutical
ingredients, as interpreted by ICH Harmonised Tripartite Guideline, Good
Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Q7a and
subject to any arrangements, additions or clarifications agreed from time to
time between the Parties in the QUALITY AGREEMENT.
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1.10 "FDA" shall mean the United States Food and Drug Administration and
any successor thereto.
1.11 "FINAL PACKAGING" shall mean the labeling, packaging, storage and
transportation of vials of BULK DRUG PRODUCT to produce FINISHED PRODUCT,
including, without limitation, the packaging of package inserts and components
reasonably necessary for sale of the FINISHED PRODUCT to the ultimate consumer,
from the time of receipt of such vials of BULK DRUG PRODUCT through the time
FINISHED PRODUCT is shipped to AVENTIS or its designees.
1.12 "FINISHED PRODUCT" shall mean PRODUCT in its finished, labeled and
packaged form, ready for sale to the market, including all samples thereof.
1.13 "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.
1.14 "FORMULATION AND FILLING" shall mean the formulation of BULK DRUG
PRODUCT from API, the filling and storage of vials with BULK DRUG PRODUCT and,
if necessary, the labeling, packaging and transportation of such vials to the
person or entity responsible for FINAL PACKAGING, from the time of receipt of
API through the time such vials of BULK DRUG PRODUCT are shipped to the person
or entity responsible for FINAL PACKAGING, or, if the person or entity
responsible for FORMULATION AND FILLING is also responsible for FINAL PACKAGING,
through the time the conduct of such FINAL PACKAGING begins.
1.15 "GENTA G3139 PATENT RIGHTS" shall mean the same as set forth in the
U.S. Commercialization Agreement.
1.16 "GOVERNMENTAL AUTHORITY" shall mean any (1) nation, state, county,
city, town, village, district or other jurisdiction of any nature; (2) federal,
state, local, municipal, foreign or other government; (3) governmental or
quasi-governmental authority of any nature (including any governmental agency,
branch, department, official or entity and any court or other tribunal,
including an arbitral tribunal); (4) multi-national organization or body; or (5)
body exercising, or entitled to exercise, any administrative, executive,
judicial, legislative, police, regulatory or taxing power of any nature.
1.17 "KEY RAW MATERIALS" shall mean (*), and such other raw materials
agreed upon by the Parties based on changes in the manufacturing process,
volumes or addition of other ACTIVE INGREDIENTS to be manufactured and supplied
by GENTA hereunder.
1.18 "KEY RAW MATERIALS SOURCING" shall mean the acquisition, storage and
transportation of all necessary KEY RAW MATERIALS to the person or entity
responsible for API PRODUCTION.
1.19 "MAA" or "Marketing Approval Application" shall mean a marketing
authorization application (including or comparable to an NDA), including all
supporting
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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.
1.20 "MAA APPROVAL" shall mean, with respect to a particular country in the
TERRITORY, approval by the applicable REGULATORY AUTHORITIES in such country of
an MAA filed in such country, permitting PRODUCT to be marketed in that country
for the indication(s) for which approval is sought, including, if applicable,
approval of pricing or reimbursement.
1.21 "MAJOR COUNTRY" shall mean (*).
1.22 "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.
1.23 "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.
1.24 "OTHER MATERIALS" shall mean all such inactive ingredients, vials,
stoppers, seals, labels, inserts, folding cartons and/or shipping cartons, and
other components as are necessary to be utilized in performance of the
PROCESSING ACTIVITIES and to meet the SPECIFICATIONS, but excluding the KEY RAW
MATERIALS.
1.25 "PROCESSING ACTIVITIES" shall mean the processing, testing and other
activities undertaken or required to be undertaken by GENTA, or its
Subcontractors, in order to manufacture and supply AVENTIS with FINISHED PRODUCT
(or, if applicable, BULK DRUG PRODUCT or API), including, without limitation,
KEY RAW MATERIALS SOURCING, API PRODUCTION, FORMULATION AND FILLING and FINAL
PACKAGING.
1.26 "PROCESSING FACILITY" shall mean any facility at which any PROCESSING
ACTIVITIES occur.
1.27 "PRODUCT" shall mean (i) the drug product specified in Exhibit 1.27;
and (ii) any other drug product containing or comprising API that is included in
the definition of "PRODUCT" under the Commercialization Agreements.
1.28 "QUALITY AGREEMENT" shall mean the technical agreement entered into
between GENTA and AVENTIS, as may be amended from time to time, which specifies
their respective responsibilities for quality control and quality assurance with
respect to PRODUCT, which agreement shall address the items specified in Exhibit
1.28.
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.29 "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.
1.30 "REGULATORY STANDARDS" shall mean (i) obtaining and maintaining any
and all permits, licenses, filings and certifications required by the FDA or
other REGULATORY AUTHORITIES, and compliance with the cGMPs of the FDA or other
REGULATORY AUTHORITIES, applicable to any PROCESSING ACTIVITIES or PROCESSING
FACILITIES, and (ii) any laws, rules, regulations and standards of any
GOVERNMENTAL AUTHORITY, whether within or outside the United States (including,
without limitation, the Environmental Protection Agency (EPA), the Occupational
Safety and Health Administration (OSHA), the Drug Enforcement Administration
(DEA) and state and local authorities), that apply to any PROCESSING ACTIVITIES
or PROCESSING FACILITIES.
1.31 "SPECIFICATIONS" shall mean the quality assurance and quality release
specifications for PRODUCT, as such specifications may be modified from time to
time in accordance with the provisions of this AGREEMENT. Exhibit 1.31 sets
forth the SPECIFICATIONS for PRODUCT as of the Effective Date, which are the
specifications in the U.S. IND for PRODUCT.
1.32 "SUPPLY CHAIN TEAM" shall have the meaning ascribed to such term in
the U.S. Commercialization Agreement.
1.33 "TECHNICAL INFORMATION" shall mean all know-how, techniques,
processes, formulae, methods, equipment specifications, documents and other
technical information necessary for proper manufacture, packaging, quality
control, release, disposal, storage, handling and/or shipping of KEY RAW
MATERIALS, API, BULK DRUG PRODUCT and/or FINISHED PRODUCT, as applicable,
including, without limitation, the SPECIFICATIONS and shelf lives for each of
the foregoing.
1.34 "TERRITORY" shall mean all countries of the world.
1.35 "THIRD PARTY(IES)" shall mean any party other than AVENTIS, GENTA and
their AFFILIATES.
1.36 "WASTE" shall mean any "hazardous substance" and/or "hazardous
material" as provided under the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), any "hazardous waste" as provided under
the Resource Conservation and Recovery Act (RCRA), and/or any other waste
material, pollutant and/or contaminant of any kind including, without
limitation, any routine process waste or any by-product arising from manufacture
of KEY RAW MATERIALS, API, BULK DRUG PRODUCT or FINISHED PRODUCT.
(*) Represents language that is redacted and subject to Confidential Treatment.
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1.37 "WORK-IN-PROCESS" shall mean API, BULK DRUG PRODUCT and any KEY RAW
MATERIALS in any form during the performance of any PROCESSING ACTIVITIES.
2. SUPPLY BY GENTA; SUBCONTRACTORS.
2.1 Commitment to Supply AVENTIS. Subject to the terms and conditions of
this AGREEMENT, GENTA shall supply or cause to be supplied, exclusively to
AVENTIS, or its designee, FINISHED PRODUCT in such amounts and at such times as
AVENTIS may order pursuant to the terms of this AGREEMENT. Unless otherwise
specified herein, as between the Parties, GENTA shall be solely responsible for
performance of all activities necessary for AVENTIS to be supplied with FINISHED
PRODUCT as contemplated hereunder, including, without limitation, all of the
PROCESSING ACTIVITIES.
2.2 Supply of Others. During the term of this AGREEMENT, and thereafter for
so long as AVENTIS continues to market and sell PRODUCT, GENTA shall not supply
API, BULK DRUG PRODUCT or FINISHED PRODUCT (including any WORK-IN-PROCESS), or
any generic versions thereof, to any person or entity other than AVENTIS, or its
designees, nor shall GENTA authorize or assist any such other person or entity
to manufacture the same; except as expressly permitted under the U.S.
Commercialization Agreement.
2.3 Subcontractors. The identity of each person or entity to whom GENTA
subcontracts, sublicenses or otherwise delegates all or any portion of its
obligations hereunder, whether AFFILIATES of GENTA or THIRD PARTIES,
(collectively, "Subcontractors") shall be subject to the prior written approval
of the SUPPLY CHAIN TEAM; provided, however, that use of the Subcontractors
identified in Exhibit 2.3 for the PROCESSING ACTIVITIES specified therein shall
not require such approval. GENTA shall negotiate and enter into a written
agreement with each Subcontractor with respect to the performance of such
obligations (each, a "Subcontractor Agreement"). The terms of each such
Subcontractor Agreement shall (i) be reasonably consistent with all of the
requirements and limitations imposed on GENTA under this AGREEMENT that are
relevant to the performance of such obligations, and (ii) afford GENTA the right
to terminate such Subcontractor Agreement for cause upon reasonable prior
notice. Each Subcontractor Agreement, and any material changes thereto, shall be
subject to prior written approval by the SUPPLY CHAIN TEAM, such approval not to
be unreasonably withheld. Moreover, GENTA shall use COMMERCIALLY REASONABLE
EFFORTS to provide that AVENTIS is a third-party beneficiary of each
Subcontractor Agreement; provided, however, that if AVENTIS is not a third-party
beneficiary of any Subcontractor Agreement, GENTA shall (i) take such actions as
are reasonably necessary to fully enforce the terms of such Subcontractor
Agreement against the applicable Subcontractor (including, without limitation,
by bringing an action against such Subcontractor for money damages), and (ii) to
the extent AVENTIS suffers damages as a result of any act or omission on the
part of such Subcontractor, pass through to AVENTIS such recoveries as GENTA
shall obtain from such Subcontractor with respect thereto, net of any actual
costs incurred by GENTA in collecting such amounts (e.g., attorneys' fees and
litigation costs) or any other amounts paid by GENTA to AVENTIS on account
thereof.
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2.4 Subcontractor Oversight. GENTA shall maintain an oversight program,
which program shall be approved by the SUPPLY CHAIN TEAM, whereby GENTA measures
and evaluates each Subcontractor's performance of any of the PROCESSING
ACTIVITIES. Notwithstanding anything to the contrary in this AGREEMENT, any
Subcontractor who fails a pre-approval inspection by any REGULATORY AUTHORITY
with respect to PRODUCT shall be prohibited from performing any PROCESSING
ACTIVITIES hereunder unless and until all problems and issues identified by such
REGULATORY AUTHORITY have been corrected to the satisfaction of the SUPPLY CHAIN
TEAM. GENTA shall keep the SUPPLY CHAIN TEAM fully informed with respect to such
corrections.
2.5 Coordination with Supply Chain Team. The SUPPLY CHAIN TEAM shall
oversee all aspects of the PROCESSING ACTIVITIES, including, without limitation,
qualification, validation and other pre-approval activities such as the
preparation for any pre-approval inspections by REGULATORY AUTHORITIES. GENTA
shall provide, and shall use COMMERCIALLY REASONABLE EFFORTS to cause its
Subcontractors to provide, the SUPPLY CHAIN TEAM with such assistance and
cooperation as the SUPPLY CHAIN TEAM shall reasonably require from time to time
in connection therewith. Notwithstanding the SUPPLY CHAIN TEAM's review or
approval of any document or activity, each Party shall remain responsible for
the fulfillment of its obligations under this AGREEMENT, except as expressly set
forth herein.
2.6 Change of Subcontractors. In accordance with the provisions of the
QUALITY AGREEMENT pertaining to change control and upon prior written consent of
the SUPPLY CHAIN TEAM, GENTA may change Subcontractors at any time.
2.7 Further Subcontracting. Except for activities that are ordinarily
conducted by third party subcontractors (including, but not limited to, quality
control and other similar testing activities), no Subcontractor shall have the
right to further subcontract, sublicense or otherwise delegate all or any
material portion of the obligations subcontracted, sublicensed or otherwise
delegated to it by GENTA without the SUPPLY CHAIN TEAM's prior written approval.
3. PROCESSING ACTIVITIES.
3.1 Quality Agreement. GENTA and AVENTIS shall enter into the QUALITY
AGREEMENT no later than sixty (60) days after the Effective Date, whereupon the
QUALITY AGREEMENT shall be appended to and shall supersede Exhibit 1.28 of this
AGREEMENT. In the event that the QUALITY AGREEMENT contains material provisions
that substantially differ from applicable comparable REGULATORY STANDARDS, the
REGULATORY STANDARDS shall control. The SUPPLY CHAIN TEAM shall determine those
Subcontractors performing any of the PROCESSING ACTIVITIES with whom GENTA shall
enter into written technical or quality agreements for the purpose of performing
any of the PROCESSING ACTIVITIES, which agreements shall address and be
materially consistent with the provisions of the QUALITY AGREEMENT and this
AGREEMENT.
3.2 Processing Facilities. The PROCESSING ACTIVITIES performed by GENTA or
any Subcontractor shall be performed only at such facilities as the SUPPLY CHAIN
TEAM shall have approved in writing; provided, however, that performance of the
PROCESSING
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ACTIVITIES by the Subcontractors identified in Exhibit 2.3 at the PROCESSING
FACILITIES specified therein shall not require such approval. In accordance with
the provisions of the QUALITY AGREEMENT pertaining to change control and upon
the SUPPLY CHAIN TEAM's prior written consent, GENTA or its Subcontractors may
change the PROCESSING FACILITIES at which all or any portion of the PROCESSING
ACTIVITIES contemplated hereunder are performed.
3.3 Sourcing of Materials. GENTA shall establish, update as necessary and
implement, and shall use COMMERCIALLY REASONABLE EFFORTS to cause its
Subcontractors to establish, update as necessary and implement, inventory
management processes and procedures reasonably designed to ensure that GENTA and
its Subcontractors are able to obtain, on a timely basis, all KEY RAW MATERIALS
and OTHER MATERIALS necessary for performance of the PROCESSING ACTIVITIES as
contemplated hereunder. Without limiting the foregoing, GENTA shall enter into,
or require its Subcontractors to enter into, written agreements for the supply
of all KEY RAW MATERIALS, which written agreements shall be subject to the prior
written approval of the SUPPLY CHAIN TEAM.
3.4 Storage, Use and Segregation of Materials and Product. GENTA shall
ensure (or, if the applicable activity is performed by Subcontractors, GENTA
shall use COMMERCIALLY REASONABLE EFFORTS to cause such Subcontractors to
ensure) that all KEY RAW MATERIALS, API, BULK DRUG PRODUCT and FINISHED PRODUCT,
as well as any WORK-IN-PROCESS, in GENTA's or its Subcontractors' possession are
stored at the applicable PROCESSING FACILITY in accordance with the requirements
of this AGREEMENT and any storage instructions provided by the SUPPLY CHAIN
TEAM. GENTA shall use (or, if the applicable activity is performed by
Subcontractors, GENTA shall use COMMERCIALLY REASONABLE EFFORTS to cause such
Subcontractors to use) the first-in first-out (FIFO) method of material usage,
subject to the prudent and appropriate usage of the first-expiring, first-out
(FEFO) method. GENTA shall ensure (or, if the applicable activity is performed
by Subcontractors, GENTA shall use COMMERCIALLY REASONABLE EFFORTS to cause such
Subcontractors to ensure) that all supplies of KEY RAW MATERIALS, API, BULK DRUG
PRODUCT and FINISHED PRODUCT, as well as any WORK-IN-PROCESS, are kept separate
from and clearly distinguished from any items or materials held by GENTA or its
Subcontractors in connection with any manufacturing, packaging, labeling or
other similar activities being conducted for themselves or for THIRD PARTIES.
GENTA shall notify AVENTIS immediately upon learning that any THIRD PARTY has
asserted any claim, right or title in any KEY RAW MATERIALS, API, BULK DRUG
PRODUCT or FINISHED PRODUCT, as well as any WORK-IN-PROCESS, in GENTA's or its
Subcontractors' possession.
3.5 Resources, Equipment and Capacity. GENTA, in consultation with the
SUPPLY CHAIN TEAM, shall use COMMERCIALLY REASONABLE EFFORTS to establish,
update as necessary and implement, and shall use COMMERCIALLY REASONABLE EFFORTS
to cause its Subcontractors to establish, update as necessary and implement,
processes and procedures reasonably designed to ensure that sufficient
manufacturing, formulation and packaging resources, equipment and production
capacity is available in order to timely fulfill GENTA's obligations hereunder,
including, without limitation, procedures for GENTA to order such API and BULK
DRUG PRODUCT as is reasonably necessary to timely fulfill its
(*) Represents language that is redacted and subject to Confidential Treatment.
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obligations hereunder. In case of a shortage of supply of KEY RAW MATERIALS, or
of availability of production capacity for any of the PROCESSING ACTIVITIES, the
supply of such materials and the availability of such production capacity within
GENTA's control or, to the extent that such Subcontractor has agreed (with GENTA
using COMMERCIALLY REASONABLE EFFORTS to obtain such agreement), its
Subcontractors' control, shall first be allocated to fulfill AVENTIS' Rolling
Forecasts and Firm Orders for FINISHED PRODUCT hereunder.
3.6 Process Validation. GENTA will require its Subcontractors to complete
validation of their equipment, facilities, formulating, manufacturing and
packaging processes, cleaning processes and other processes as required by cGMPs
and any other applicable REGULATORY STANDARDS so as to ensure that all
PROCESSING ACTIVITIES are able to commence in accordance with such requirements
by January 1, 2003, except to the extent that the Parties mutually agree to a
different filing date for the first NDA that makes it reasonable to postpone
such date appropriately (other than due to GENTA's failure to fulfill its
obligations under this Section 3.6). To the extent it is necessary to conduct
any such validation activities anytime thereafter during the term of this
AGREEMENT, GENTA, in consultation with the SUPPLY CHAIN TEAM, shall oversee the
proper conduct of such activities. GENTA will routinely assemble and retain, and
will require that its Subcontractors assemble and retain, any required
validation/qualification documents and validation summary reports pertaining to
the PROCESSING ACTIVITIES, for a period of time as agreed under the QUALITY
AGREEMENT. GENTA will provide, and will use COMMERCIALLY REASONABLE EFFORTS to
cause its Subcontractors to provide, copies of such documents and reports to
AVENTIS upon request.
3.7 Facility Registrations. GENTA shall maintain in good order (or, with
respect to activities conducted by Subcontractors, GENTA shall use COMMERCIALLY
REASONABLE EFFORTS to cause such Subcontractors to maintain in good order) such
current Annual Registration of Drug Establishment registrations (form FDA 2656e)
granted by the FDA, and any comparable registrations granted by any other
REGULATORY AUTHORITY (each, a "Registration), for so long and insofar as is
necessary to permit GENTA (or any such Subcontractor) to perform any PROCESSING
ACTIVITIES as contemplated hereunder. GENTA will make, and will use COMMERCIALLY
REASONABLE EFFORTS to require its Subcontractors to make, copies of such
Registrations and all related documents available to AVENTIS and its designees
for inspection, upon reasonable request from AVENTIS.
3.8 Regulatory Communications and Correspondence. GENTA shall require each
Subcontractor to promptly notify it, and shall itself promptly notify the SUPPLY
CHAIN TEAM, of all communications from the FDA or other REGULATORY AUTHORITIES
which may impact or change the PROCESSING ACTIVITIES performed by GENTA or such
Subcontractor, or affect the ability of GENTA to comply with its obligations
under this AGREEMENT. Without limiting the foregoing, GENTA shall require each
Subcontractor to notify it, and shall itself notify the SUPPLY CHAIN TEAM, of
any written or oral inquiries, notifications or inspection activities by any
REGULATORY AUTHORITY in regard to PRODUCT within (*) business days of GENTA or
such Subcontractor, as applicable, obtaining knowledge of such inquiries,
notifications or inspection activities. Moreover, GENTA shall require each
Subcontractor to furnish it with, and shall itself furnish to the SUPPLY
(*) Represents language that is redacted and subject to Confidential Treatment.
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CHAIN TEAM, copies of all inspection reports and related correspondence of such
REGULATORY AUTHORITY related to or which might reasonably affect performance of
any PROCESSING ACTIVITIES hereunder (including, without limitation, any FDA Form
483 or other inspection reports, warning letters, citations, indictments,
claims, lawsuits or proceedings issued or instituted against GENTA or such
Subcontractor, or of any revocation of any license or permit issued to GENTA or
such Subcontractor) and when such reports and correspondence become available to
GENTA, but in any event within (*) days after obtaining knowledge of such
inquiries, notifications or inspection activities. GENTA will discuss with the
SUPPLY CHAIN TEAM, and will use COMMERCIALLY REASONABLE EFFORTS to cause its
Subcontractors to discuss with the SUPPLY CHAIN TEAM, any REGULATORY AUTHORITY
comments directly related to and affecting GENTA's or such Subcontractor's
performance of any PROCESSING ACTIVITIES, and before GENTA or such Subcontractor
submits a final response to such comments, GENTA shall give the SUPPLY CHAIN
TEAM, or shall use COMMERCIALLY REASONABLE EFFORTS to cause such Subcontractor
to give the SUPPLY CHAIN TEAM, no fewer than (*) business days to comment on its
proposed response to such comments, and any resultant SUPPLY CHAIN TEAM comments
will be incorporated to the response, if reasonably possible. GENTA shall
promptly rectify or resolve, and shall use COMMERCIALLY REASONABLE EFFORTS to
cause its Subcontractors to promptly rectify or resolve, any deficiencies noted
by a REGULATORY AUTHORITY in a report or correspondence issued to GENTA or its
Subcontractors that relate to performance of any of the PROCESSING ACTIVITIES.
3.9 Packaging Materials and Labeling. A reasonable time prior to the FIRST
COMMERCIAL SALE in a particular country, and whenever implementing a material
change in the packaging materials for FINISHED PRODUCT for any country, AVENTIS
shall provide GENTA with the layout of such packaging materials, including all
package inserts, labels, artwork, drawings and other elements, and with any
associated packaging and labeling specifications, all of which shall be
consistent with REGULATORY STANDARDS and the requirements of the
Commercialization Agreements. GENTA will establish, update as necessary and
implement, and shall use COMMERCIALLY REASONABLE EFFORTS to cause its
Subcontractors to establish, update as necessary and implement, processes and
procedures reasonably designed to ensure that all FINISHED PRODUCT is labeled
and packaged in accordance with such packaging and labeling specifications.
Except with the prior written approval of the SUPPLY CHAIN TEAM, GENTA shall not
include any other packaging or inserts with, or affix any other labeling or
artwork to, the FINISHED PRODUCT. If AVENTIS requires GENTA to make any change
to such packaging materials within a time period that would not permit GENTA or
its Subcontractors to utilize their existing reasonable levels of inventories of
such materials through normal manufacturing schedules, AVENTIS will reimburse
GENTA for the obsolescence cost of such materials.
3.10 Manufacturing and Regulatory Changes. The Parties will inform each
other with sufficient notice so that the required actions can be taken in due
time, of all significant changes to suppliers of KEY RAW MATERIALS and OTHER
MATERIALS, formulations, processes, equipment, facilities, specifications, tests
or any item that would affect the MAA APPROVAL or any other regulatory filings
for PRODUCT. No such material changes shall be implemented without the prior
written approval of the SUPPLY CHAIN TEAM. To the extent that GENTA
(*) Represents language that is redacted and subject to Confidential Treatment.
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actually incurs any costs as a result thereof, such costs shall, if applicable,
be charged to AVENTIS pursuant to Section 10.1.5 or 10.8.
3.11 Accident Reports. GENTA shall require each Subcontractor to promptly
notify it, and shall itself promptly notify AVENTIS, of all material accidents
related to the manufacture, handling, use or storage of KEY RAW MATERIALS, API,
BULK DRUG PRODUCT or FINISHED PRODUCT, as well as any WORK-IN-PROCESS,
including, without limitation: (i) accidents resulting in significant personal
injury requiring more than first aid treatment, (ii) accidents resulting in
chronic illness or loss of consciousness, (iii) accidents resulting in material
property damage, (iv) accidents resulting in material environmental release, and
(v) accidents that result in regulatory, safety, health or environmental audits.
3.12 Handling of Materials; Wastes. GENTA shall require its Subcontractors
to inform their employees, contractors and other personnel of any known or
reasonably ascertainable chemical hazards associated with the KEY RAW MATERIALS,
OTHER MATERIALS, BULK DRUG PRODUCT or FINISHED PRODUCT, or any WASTES generated
through performance of the PROCESSING ACTIVITIES, and to provide such persons
with reasonable training in the proper methods of handling and disposing of such
items. In addition, GENTA shall use COMMERCIALLY REASONABLE EFFORTS to ensure
that its Subcontractors handle, accumulate, label, package, ship and dispose of
all WASTES generated through performance of the PROCESSING ACTIVITIES in
accordance with all applicable laws, rules, regulations and orders of any
GOVERNMENTAL AUTHORITY.
3.13 Documentation. GENTA shall maintain (or, if the applicable activity is
performed by Subcontractors, GENTA shall use COMMERCIALLY REASONABLE EFFORTS to
cause such Subcontractors to maintain) complete and accurate documentation of
all validation data, stability testing data, batch records, quality control and
laboratory testing and any other data required under cGMPs and other
requirements of any relevant GOVERNMENTAL AUTHORITY in connection with the
performance of any PROCESSING ACTIVITIES hereunder. GENTA shall provide, and
shall use COMMERCIALLY REASONABLE EFFORTS to cause its Subcontractors to
provide, AVENTIS with such documentation promptly upon AVENTIS' request.
3.14 Monitoring and Recordkeeping; Operating Procedures. Throughout the
term of this AGREEMENT, and for so long thereafter as is reasonably necessary,
GENTA shall monitor and maintain, and shall use COMMERCIALLY REASONABLE EFFORTS
to cause its Subcontractors to monitor and maintain, reasonable records
respecting their compliance with cGMPs, including through the establishment and
implementation of such operating procedures as are reasonably necessary to
assure such compliance. GENTA shall use COMMERCIALLY REASONABLE EFFORTS to cause
its Subcontractors to notify it in writing, and will itself notify the SUPPLY
CHAIN TEAM in writing, of any significant trend changes in the statistical
process control data and/or quality testing results for batches of API, BULK
DRUG PRODUCT or FINISHED PRODUCT manufactured for supply to AVENTIS hereunder.
3.15 Inspection and Audit. GENTA shall permit AVENTIS to inspect and audit
(or, if the applicable facility is operated by a Subcontractor, GENTA shall use
COMMERCIALLY REASONABLE EFFORTS to cause such Subcontractors to permit AVENTIS
to inspect and
(*) Represents language that is redacted and subject to Confidential Treatment.
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audit) (a) those portions of each of PROCESSING FACILITY at which any PROCESSING
ACTIVITIES are performed, and (b) any of GENTA's or its Subcontractors'
manufacturing and quality control records and other documentation relating to
the PROCESSING ACTIVITIES (including, without limitation, any internal quality
control audits or reviews conducted by GENTA or its Subcontractors). Such
inspections and audits shall be for the purpose of ascertaining compliance with
GENTA's obligations under the QUALITY AGREEMENT and this AGREEMENT, reviewing
correspondence, reports, filings and other documents from or to REGULATORY
AUTHORITIES to the extent related to the PROCESSING ACTIVITIES, and approving
all variances from applicable requirements hereunder or under the QUALITY
AGREEMENT. Any information obtained by AVENTIS through such inspections and
audits shall be treated as Confidential Information of GENTA. Such audits and
inspections shall be conducted at AVENTIS' expense during normal business hours
and upon reasonable notice, and in a manner that does not unreasonably interfere
with ongoing operations. GENTA shall promptly correct (or, if correction would
need to be implemented by a Subcontractor, GENTA shall use COMMERCIALLY
REASONABLE EFFORTS to cause such Subcontractor to promptly correct) any problems
or issues identified as a result of any such inspection or audit to the extent
that such problems or issues result from a failure to comply with cGMPs (or
other applicable REGULATORY STANDARDS). GENTA shall provide AVENTIS with, and
use COMMERCIALLY REASONABLE EFFORTS to require its Subcontractors to provide
AVENTIS with, reasonable documentary and other evidence of such correction.
3.16 Annual Product Review. Consistent with the provisions of 21 C.F.R. ss.
211.180(e), GENTA shall conduct an annual product review, as required, for the
PRODUCT. GENTA shall use COMMERCIALLY REASONABLE EFFORTS to require its
Subcontractors, upon GENTA's reasonable request and expense and in support of an
annual product review process, to provide GENTA with the information required
under 21 C.F.R. ss. 211.180(e)(1) to permit a review of a representative number
of batches of API, BULK DRUG PRODUCT and/or FINISHED PRODUCT, as applicable,
whether approved or rejected. Upon the SUPPLY CHAIN TEAM's reasonable request,
GENTA shall provide to the SUPPLY CHAIN TEAM copies of all correspondence with
REGULATORY AUTHORITIES pertaining to the annual product review in sufficient
time for the SUPPLY CHAIN TEAM to comment.
4. FORECASTING AND ORDERING.
4.1 Long-Range Forecasts. By July 1 of each CALENDAR YEAR, AVENTIS shall
provide GENTA with a non-binding good faith estimate of the quantities of
FINISHED PRODUCT that AVENTIS foresees it will order from GENTA for each of the
next (*) CALENDAR YEARS. Such forecasts shall be for long-range planning
purposes only and shall in no way be binding on AVENTIS or GENTA.
4.2 Rolling Forecasts; Firm Orders.
4.2.1 By (*), and thereafter by the (*) day of each CALENDAR MONTH,
AVENTIS shall provide GENTA with a good-faith written forecast of the quantities
of FINISHED PRODUCT that AVENTIS will require from GENTA for the following (*)
CALENDAR MONTHS (each, a "Rolling Forecast"). Thus, for example,
(*) Represents language that is redacted and subject to Confidential Treatment.
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the Rolling Forecast provided by (*) shall cover the CALENDAR MONTHS commencing
with (*) and ending with (*).
4.2.2 AVENTIS' specified requirements for FINISHED PRODUCT for the
first (*) CALENDAR MONTHS of each Rolling Forecast shall constitute a binding
order for the purchase of the FINISHED PRODUCT (each, a "Firm Order"). The
remainder of any Rolling Forecast shall be non-binding; provided, however, that
AVENTIS shall be required to place Firm Orders with GENTA for at least (*) of
its forecasted requirements for FINISHED PRODUCT for the (*) CALENDAR MONTHS of
each Rolling Forecast.
4.2.3 GENTA shall not be obligated to satisfy that portion of any Firm
Order that exceeds (i) AVENTIS' forecasted requirements for FINISHED PRODUCT for
each of the (*) CALENDAR MONTHS of any Rolling Forecast by more than (*), and
(ii) AVENTIS' forecasted requirements for FINISHED PRODUCT for each of the (*)
CALENDAR MONTHS of any Rolling Forecast by more than (*) (any such amount, the
"Excess Portion"). Notwithstanding the foregoing, GENTA shall use, and shall use
COMMERCIALLY REASONABLE EFFORTS to require its Subcontractors to use,
COMMERCIALLY REASONABLE EFFORTS to satisfy the Excess Portion of any Firm Order.
4.2.4 Should GENTA in good faith order reasonable quantities of API
for use in the production of FINISHED PRODUCT in the amount specified in any
Rolling Forecast as being required by AVENTIS during a particular period, and
should such API not then be needed to produce FINISHED PRODUCT for supply to
AVENTIS during such period due to a reduction by AVENTIS of its requirements of
FINISHED PRODUCT, AVENTIS shall reimburse GENTA for the reasonable out-of-pocket
cost of required retesting of such API in order to permit its use in producing
FINISHED PRODUCT required by AVENTIS for any subsequent period.
4.3 Purchase Orders.
4.3.1 Each Rolling Forecast shall be accompanied by one or more
purchase orders for FINISHED PRODUCT covered by that portion of the Rolling
Forecast constituting a Firm Order (each, a "Purchase Order"). All Purchase
Orders shall be for full batch quantities of FINISHED PRODUCT or multiples
thereof. Each Purchase Order shall separately state whether the FINISHED PRODUCT
covered by such Purchase Order is being ordered by AVENTIS US or AVENTIS
IRELAND.
4.3.2 GENTA shall acknowledge and provide AVENTIS with a written
acceptance of each Purchase Order within five (5) business days following
GENTA's receipt thereof. GENTA shall be entitled to reject only that portion of
any Purchase Order which GENTA will be unable to fill due to the occurrence of a
Force Majeure, or which constitutes the Excess Portion of any Firm Order and
GENTA, despite its COMMERCIALLY REASONABLE EFFORTS, is unable to supply such
Excess Portion.
(*) Represents language that is redacted and subject to Confidential Treatment.
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4.3.3 Other than terms respecting quantity, delivery date(s), shipment
method and destination(s), the terms and conditions of any Purchase Order
submitted by AVENTIS, or written acceptance thereof by GENTA, shall be of no
force and effect, whether or not objected to by the other Party, and nothing in
any such Purchase Order or written acceptance shall supersede the terms and
conditions of this AGREEMENT or the QUALITY AGREEMENT.
4.4 Addressees for Correspondence. All Rolling Forecasts, Firm Orders,
Purchase Orders, written acceptances of Purchase Orders and other notices
contemplated under this Section 4 shall be sent to the attention of such persons
as each Party may identify to the other in writing from time to time.
4.5 Clinical and Research Supplies. GENTA shall supply AVENTIS with such
quantities of FINISHED PRODUCT, BULK DRUG PRODUCT and/or API as are reasonably
requested by AVENTIS in order for it to conduct clinical trials, preclinical
studies and other research and development activities with respect to PRODUCT.
(*). AVENTIS will reimburse GENTA for the out-of-pocket amounts actually paid by
GENTA for such FINISHED PRODUCT, BULK DRUG PRODUCT and/or API, (*).
4.6 Second Source of Supply. GENTA, in consultation with and subject to the
approval of the SUPPLY CHAIN TEAM, shall use COMMERCIALLY REASONABLE EFFORTS to
establish or require its Subcontractors to establish second sources of supply
for all KEY RAW MATERIALS, API and FINISHED PRODUCT so as to reasonably ensure
GENTA's ability to fulfill its obligations to supply FINISHED PRODUCT to AVENTIS
hereunder in a timely manner.
4.7 Delay in Obtaining Regulatory Approval. Notwithstanding anything to the
contrary herein, GENTA shall promptly reimburse AVENTIS for (*) of all amounts
paid by AVENTIS to GENTA for reasonable quantities of FINISHED PRODUCT purchased
or ordered by AVENTIS prior to and in reasonable anticipation of obtaining MAA
APPROVAL for PRODUCT in the United States, together with any associated costs
and expenses, to the extent AVENTIS is unable to sell such FINISHED PRODUCT at
full price because of a delay in obtaining such MAA APPROVAL that results in
such FINISHED PRODUCT being expired or unreasonably short dated (i.e., having a
remaining shelf life of less than (*)) as of the date such MAA APPROVAL is
finally obtained; provided, however, that if such delay is primarily
attributable to the fault of AVENTIS, then GENTA shall have no obligation to
provide such reimbursement, and provided, further, that if such delay is
(*) Represents language that is redacted and subject to Confidential Treatment.
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primarily attributable to the fault of GENTA, then GENTA shall be required to
reimburse AVENTIS for (*) of such amounts. To the extent GENTA is required to
reimburse AVENTIS for any such amounts, AVENTIS shall have the right to deduct
such amounts from any amounts due to GENTA hereunder or under the
Commercialization Agreements. Nothing in this Section 4.7 shall limit any legal,
equitable or other rights or remedies that may be available to either Party on
account of any delay in obtaining MAA APPROVAL for PRODUCT which is attributable
to the other Party.
5. SHIPPING AND DELIVERY.
5.1 Shipping and Delivery Dates. On each Purchase Order submitted by
AVENTIS, AVENTIS shall specify the requested quantity, delivery date(s),
shipment method and destination(s) of FINISHED PRODUCT being ordered. GENTA
shall arrange for the delivery of FINISHED PRODUCT to AVENTIS' designated
facilities as stated on the Purchase Order and in a manner consistent with good
commercial practices, any agreed-upon shipping specifications and the QUALITY
AGREEMENT. Any shipment delivered that is within plus or minus (*) of the
quantity ordered and plus or minus five (5) calendar days of the delivery date
specified on the relevant Purchase Order will be considered as delivered within
the ordered quantity and on time.
5.2 Terms of Delivery. All shipments of FINISHED PRODUCT to AVENTIS shall
be by a carrier selected by AVENTIS, FCA (Incoterms 2000) the PROCESSING
FACILITY at which FINAL PACKAGING is completed. If AVENTIS does not timely
indicate in writing its selection of a carrier to GENTA, GENTA shall be entitled
to select an appropriate carrier. Unless otherwise instructed by AVENTIS, GENTA
shall arrange for appropriate insurance coverage for all shipments of FINISHED
PRODUCT to AVENTIS' designated facility as stated on the Purchase Order. Title
to all FINISHED PRODUCT shipped on behalf of AVENTIS US shall transfer to
AVENTIS US, whereas title to all FINISHED PRODUCT shipped on behalf of AVENTIS
IRELAND shall transfer to AVENTIS IRELAND.
5.3 Shipping Costs. AVENTIS shall pay all costs, expenses, taxes, levies,
tariffs, brokerage fees, insurance premiums and other costs and charges assessed
or levied in connection with the transportation of FINISHED PRODUCT from the
PROCESSING FACILITY at which FINAL PACKAGING is completed (or, if BULK DRUG
PRODUCT is shipped to AVENTIS, where FORMULATION AND FILLING is completed and,
if API is shipped to AVENTIS, where API PRODUCTION is completed) to AVENTIS'
designated facility (the "Shipping Costs"). If GENTA pays any of the Shipping
Costs on behalf of AVENTIS, then GENTA shall invoice such Shipping Costs to
AVENTIS and AVENTIS shall pay such costs in accordance with the provisions of
Section 11 below.
5.4 Shelf Life. All FINISHED PRODUCT supplied to AVENTIS shall have the
longest remaining shelf life reasonably possible, but in any event a minimum of
(*) of its remaining shelf life if the total shelf life is less than (*), or a
minimum of (*) of its remaining shelf life if the total shelf life is equal to
or greater than (*), unless otherwise agreed in writing by AVENTIS on a
case-by-case or lot-by-lot basis.
(*) Represents language that is redacted and subject to Confidential Treatment.
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5.5 Accompanying Documentation. With each shipment of FINISHED PRODUCT,
GENTA shall provide AVENTIS with commercially appropriate shipping
documentation, including, without limitation, bills of lading, and with such
certificates of conformance and other appropriate documentation identifying the
applicable batch numbers, indicating conformance of the shipment with the
SPECIFICATIONS, the QUALITY AGREEMENT and all REGULATORY STANDARDS, and, at
AVENTIS' request, GENTA shall provide AVENTIS with reasonable access to any
applicable supporting data.
5.6 Release of Shipments. Unless otherwise agreed in writing by the
Parties, GENTA shall not ship or permit any Subcontractor to ship FINISHED
PRODUCT to AVENTIS until such time as GENTA has provided AVENTIS with all
required release documents and, if AVENTIS is responsible for the release of
such FINISHED PRODUCT, AVENTIS has notified GENTA that the FINISHED PRODUCT is
released for shipment in accordance with the provisions of the QUALITY
AGREEMENT.
5.7 Retention of Samples. GENTA shall properly store and retain (or, if
storage by its Subcontractors would be customary, GENTA shall use COMMERCIALLY
REASONABLE EFFORTS to cause such Subcontractors to properly store and retain)
appropriate samples (identified by batch number) of (a) FINISHED PRODUCT that it
supplies to AVENTIS, (b) all API and BULK DRUG PRODUCT used in the production of
FINISHED PRODUCT, and (c) all KEY RAW MATERIALS and OTHER MATERIALS (except
water, compressed gases and highly volatile compounds) used to manufacture,
formulate or package API, BULK DRUG PRODUCT and FINISHED PRODUCT, in each case
in conditions and for times consistent with all applicable REGULATORY STANDARDS
and to permit appropriate or required internal and regulatory checks and
references (collectively, the "Shipment Samples"). GENTA shall provide, and
shall use COMMERCIALLY REASONABLE EFFORTS to cause its Subcontractors to
provide, AVENTIS with reasonable access to and portions of the Shipment Samples
for testing and other purposes upon its request.
5.8 No Other Disposition. Except as expressly permitted hereunder or under
the U.S. Commercialization Agreement, no disposition or disposal of any FINISHED
PRODUCT, BULK DRUG PRODUCT or API to AVENTIS or otherwise, shall be made by
GENTA or any of its Subcontractors without the advance approval of the SUPPLY
CHAIN TEAM.
6. INSPECTION AND DEFECTIVE PRODUCTS.
6.1 Inspection by AVENTIS.
6.1.1 Within thirty (30) days following its receipt of a shipment of
FINISHED PRODUCT, AVENTIS shall inspect (or have inspected) such shipment for
transport damages, shortage and, as far as reasonably practicable, any other
defects. AVENTIS shall notify GENTA of any such damages, shortage and other
defects discovered by AVENTIS promptly following AVENTIS' discovery thereof, but
in any event within thirty (30) days.
6.1.2 With respect to any FINISHED PRODUCT that AVENTIS is responsible
for the release of, within forty-five (45) days following its receipt of a
shipment of FINISHED PRODUCT, AVENTIS shall perform (or have performed) such
quality control testing on the
(*) Represents language that is redacted and subject to Confidential Treatment.
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FINISHED PRODUCT as is required to be performed by AVENTIS under the QUALITY
AGREEMENT in order to determine whether the FINISHED PRODUCT conforms to the
SPECIFICATIONS. AVENTIS shall notify GENTA of any non-conformance with the
SPECIFICATIONS discovered by AVENTIS promptly following AVENTIS' discovery
thereof, but in any event within forty-five (45) days.
6.1.3 If notice is not given by AVENTIS pursuant to Section 6.1.1 or
Section 6.1.2 within the time periods set forth therein, then the shipment shall
be deemed accepted by AVENTIS for purposes of this Section 6 and, except as
provided in Section 6.2, may not be rejected pursuant to Section 6.3 or Section
6.4.
6.2 Latent Defects. In the case of FINISHED PRODUCT with defects not
readily discoverable prior to the shipment of any FINISHED PRODUCT to AVENTIS,
or thereafter within the time periods specified in Section 6.1 above, each Party
shall notify the other Party of any such defects discovered by such Party
promptly following such Party's discovery thereof.
6.3 Defective Products.
6.3.1 In any case where AVENTIS expects to reject or otherwise make a
claim against GENTA with respect to damaged, non-conforming or otherwise
defective FINISHED PRODUCT, GENTA shall be offered a reasonable opportunity to
offer proof or evidence as to why such FINISHED PRODUCT should not be rejected
and to inspect and/or test such FINISHED PRODUCT.
6.3.2 In the event of any dispute as to whether FINISHED PRODUCT may
be rightfully rejected by AVENTIS, such FINISHED PRODUCT shall be tested for
conformance with the applicable SPECIFICATIONS and acceptance criteria by an
independent testing organization mutually acceptable to both Parties, which
analysis shall be binding on AVENTIS and GENTA solely for the purpose of
determining whether such FINISHED PRODUCT may be rightfully rejected as
non-conforming, damaged or otherwise defective. The fees and expenses charged by
such independent testing organization shall be paid by the Party in error.
6.3.3 All or part of any shipment of FINISHED PRODUCT determined to
have been rightfully rejected by AVENTIS shall be held by AVENTIS for a period
of sixty (60) days following notice to GENTA for proper disposal by GENTA, at
GENTA's expense. If GENTA does not provide instructions for disposition of the
FINISHED PRODUCT within such sixty (60) day period then AVENTIS may dispose of
such FINISHED PRODUCT and GENTA shall either pay or reimburse AVENTIS for all
costs and expenses incurred by AVENTIS in connection with the disposition of
such FINISHED PRODUCT.
6.4 Remedies. In the event AVENTIS receives FINISHED PRODUCT from GENTA
that is non-conforming or otherwise defective, AVENTIS may elect for GENTA to
replace such non-conforming or otherwise defective FINISHED PRODUCT with an
equal quantity of FINISHED PRODUCT that conforms to the SPECIFICATIONS and is
not otherwise defective. If AVENTIS requests GENTA to replace such
non-conforming or otherwise defective FINISHED PRODUCT as set forth above, GENTA
shall replace such FINISHED PRODUCT as soon as is reasonably possible at no
additional cost to AVENTIS. Nothing in this Section 6.4
(*) Represents language that is redacted and subject to Confidential Treatment.
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shall limit any legal, equitable or other rights or remedies that may be
available to AVENTIS on account of GENTA's delivery to AVENTIS of FINISHED
PRODUCT that is non-conforming or otherwise defective.
6.5 Risk of Expiry. Subject to compliance by AVENTIS with its requirements
under this AGREEMENT and the QUALITY AGREEMENT, the risk of expiry of FINISHED
PRODUCT not yet delivered to AVENTIS shall be borne exclusively by GENTA.
7. FAILURE TO SUPPLY.
7.1 Notice of Inability to Supply. GENTA shall immediately notify AVENTIS
in writing if and when GENTA determines that it will be unable to satisfy, or if
GENTA receives any information reasonably suggesting that it might be unable to
satisfy, all or any portion of a Rolling Forecast or Firm Order, including the
Excess Portion of any Firm Order. In particular, GENTA shall immediately inform
AVENTIS of any notice, written or oral, received from any of its Subcontractors
regarding a possible shortage or inability to obtain or supply FINISHED PRODUCT,
BULK DRUG PRODUCT, API or any components or materials used in the manufacture
thereof.
7.2 Consequences of Failure. In the case of any material failure or
anticipated material failure of GENTA to supply FINISHED PRODUCT meeting the
requirements of this AGREEMENT in the quantities and within the time periods
specified in AVENTIS' Firm Orders and Purchase Orders (each, a "Failure"), GENTA
shall use COMMERCIALLY REASONABLE EFFORTS, and shall use COMMERCIALLY REASONABLE
EFFORTS to cause its Subcontractors to, remedy the Failure and resume supplying
acceptable FINISHED PRODUCT to AVENTIS as soon as is reasonably possible,
and/or, upon AVENTIS' request, to fully cooperate with AVENTIS to secure
adequate supplies of FINISHED PRODUCT from alternative sources. Moreover, in the
event of any Failure that is not attributable to AVENTIS and that results in the
material cancellation of PRODUCT orders, AVENTIS shall be relieved from its
obligations under this AGREEMENT to purchase any quantities of FINISHED PRODUCT
identified in any outstanding committed portions of Rolling Forecasts, Firm
Orders or Purchase Orders to the extent such FINISHED PRODUCT cannot reasonably
be sold without AVENTIS incurring a loss.
7.3 Costs Attributable to a Failure. GENTA shall use COMMERCIALLY
REASONABLE EFFORTS to ensure that its Subcontractors have substantial incentives
to avoid any Failure. (*).
7.4 Reservation of Rights. Nothing in this Section 7 shall limit any legal,
equitable or other rights or remedies that may be available to AVENTIS on
account of any Failure.
(*) Represents language that is redacted and subject to Confidential Treatment.
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8. DISCONTINUANCE OF SALES; PRODUCT RECALL.
8.1 Discontinuance of Sales. AVENTIS, at any time and without liability to
GENTA, shall be entitled to cease, permanently or temporarily, sales of FINISHED
PRODUCT in any country if continued sales of FINISHED PRODUCT in such country
would be in violation of any applicable laws or regulations, or if the SUPPLY
CHAIN TEAM determines that there is an ethically valid reason to cease such
sales based on medical or scientific concerns relating to such FINISHED PRODUCT.
8.2 Product Recall. The Parties shall handle any recall or other corrective
action with respect to FINISHED PRODUCT in accordance with the provisions of the
Commercialization Agreements.
8.3 Continuing Obligations; Reimbursement of Costs.
8.3.1 Recall Attributable to GENTA. In the event of a withdrawal or
recall of FINISHED PRODUCT pursuant to this Section 8 that is attributable
predominantly to the fault of GENTA, AVENTIS shall have the right to cancel any
Rolling Forecasts, Firm Orders and Purchase Orders already submitted, and
AVENTIS shall have no obligations or liabilities with respect to any FINISHED
PRODUCT not yet shipped to AVENTIS, or for any KEY RAW MATERIALS, OTHER
MATERIALS, API or BULK DRUG PRODUCT used or ordered in anticipation of
fulfilling any such Rolling Forecasts, Firm Orders or Purchase Orders.
8.3.2 Recall Attributable to AVENTIS. In the event of a withdrawal or
recall pursuant to this Section 8 that is attributable predominantly to the
fault of AVENTIS:
(a) Unless otherwise instructed by AVENTIS, GENTA shall complete
or cause the completion of all PROCESSING ACTIVITIES with respect to any
FINISHED PRODUCT that is in the process of being manufactured by GENTA or its
Subcontractors on the date that GENTA receives notice from AVENTIS of the
withdrawal or recall. Whether AVENTIS gives any instruction to the contrary or
not, all such FINISHED PRODUCT required to fill any outstanding committed
portions of Rolling Forecasts, Firm Orders and Purchase Orders of AVENTIS shall
be invoiced in full to and paid for by AVENTIS in accordance with the terms of
this AGREEMENT.
(b) Unless otherwise instructed by AVENTIS, AVENTIS shall be
deemed to have canceled all Rolling Forecasts, Firm Orders and Purchase Orders
for FINISHED PRODUCT not already in the process of being manufactured by GENTA
or its Subcontractors on the date that GENTA receives notice from AVENTIS of the
withdrawal or recall.
(c) AVENTIS shall reimburse GENTA for any costs incurred by GENTA
(or to which GENTA is irrevocably committed) in connection with any PROCESSING
ACTIVITIES undertaken by GENTA or its Subcontractors in reasonable anticipation
of providing any quantities of FINISHED PRODUCT AVENTIS has committed to
purchase under any committed portion of a Rolling Forecast, Firm Order or
Purchase Order applicable at the time GENTA receives notice from AVENTIS of the
withdrawal or recall.
(*) Represents language that is redacted and subject to Confidential Treatment.
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8.3.3 No Fault Recall. In the event of a withdrawal or recall pursuant
to this Section 8 that is not attributable predominantly to the fault of
AVENTIS, or of GENTA or its Subcontractors:
(a) Unless otherwise instructed by AVENTIS, GENTA shall complete
or cause the completion of all PROCESSING ACTIVITIES with respect to any
FINISHED PRODUCT that is in the process of being manufactured by GENTA or its
Subcontractors on the date that GENTA receives notice from AVENTIS of the
withdrawal or recall. Whether AVENTIS gives any instruction to the contrary or
not, all such FINISHED PRODUCT required to fill any outstanding committed
portions of Rolling Forecasts, Firm Orders and Purchase Orders of AVENTIS shall
be invoiced at (*) of full cost to and paid for by AVENTIS in accordance with
the terms of this AGREEMENT.
(b) Unless otherwise instructed by AVENTIS, AVENTIS shall be
deemed to have canceled all Rolling Forecasts, Firm Orders and Purchase Orders
for FINISHED PRODUCT not already in the process of being manufactured by GENTA
or its Subcontractors on the date that GENTA receives notice from AVENTIS of the
withdrawal or recall.
(c) AVENTIS shall reimburse GENTA for (*) of any costs incurred
by GENTA (or to which GENTA is irrevocably committed) in connection with any
PROCESSING ACTIVITIES undertaken by GENTA or its Subcontractors in reasonable
anticipation of providing any quantities of FINISHED PRODUCT AVENTIS has
committed to purchase under any committed portion of a Rolling Forecast, Firm
Order or Purchase Order applicable at the time GENTA receives notice from
AVENTIS of the withdrawal or recall.
9. ASSUMPTION OF PROCESSING ACTIVITIES BY AVENTIS.
9.1 Notice of Assumption. AVENTIS shall have the right to assume
responsibility for the performance of any or all of the PROCESSING ACTIVITIES,
for one or more countries, upon written notice to GENTA given reasonably in
advance of the date such assumption of responsibility is to become effective;
provided, however, that AVENTIS shall have the right to assume responsibility
for the performance of any PROCESSING ACTIVITIES responsible for causing a
Failure that is not attributable to AVENTIS promptly following written notice to
GENTA, said notice to be given at any time following such Failure up to the time
that AVENTIS determines that the Failure has been remedied and is unlikely to
recur. Notwithstanding the foregoing, AVENTIS' assumption of responsibility for
the performance of all or any portion of any PROCESSING ACTIVITY then-being
conducted by a Subcontractor shall be subject to any then-outstanding
obligations of GENTA under the applicable Subcontractor Agreement with such
Subcontractor, including, without limitation, any amounts required to be paid by
GENTA to the Subcontractor on account of the early termination of such
Subcontractor Agreement.
9.2 Transfer of Technical Information. Promptly following AVENTIS'
provision to GENTA of any notice that AVENTIS has elected to assume
responsibility for performance of specified PROCESSING ACTIVITIES, GENTA shall
transfer to AVENTIS or its designee, or, to the extent permitted under the
applicable Subcontractor Agreement, arrange for the applicable Subcontractor to
transfer to AVENTIS or its designee, of all TECHNICAL INFORMATION, regulatory
information and other information and materials reasonably necessary for AVENTIS
(*) Represents language that is redacted and subject to Confidential Treatment.
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to assume responsibility for performance of such activities, and the Parties
shall establish such operational procedures as are reasonably necessary for
AVENTIS or its designee to assume such responsibility. Such transfer shall
include, without limitation, reasonable time to consult with GENTA's technical
personnel (and, to the extent available, its Subcontractors' technical
personnel) on the specified PROCESSING ACTIVITIES, and to observe GENTA's
performance (and, to the extent permitted, its Subcontractors' performance) of
such activities in actual practice, both during the during the transfer and for
a minimum period of twelve (12) months thereafter. GENTA shall use COMMERCIALLY
REASONABLE EFFORTS to cause its Subcontractors to provide AVENTIS or its
designee with such access to such personnel and activities. AVENTIS shall bear
the reasonable out-of-pocket costs and expenses incurred by GENTA in connection
with facilitating the transfer of any PROCESSING ACTIVITIES to AVENTIS or its
designee, including any such amounts payable to the Subcontractor from whom such
responsibility is being assumed.
9.3 License Rights. Effective at such time as AVENTIS assumes
responsibility for the performance of any PROCESSING ACTIVITIES as contemplated
hereunder, GENTA shall grant to AVENTIS or its designee, (or, if the applicable
activities are being performed by a Subcontractor, GENTA shall use COMMERCIALLY
REASONABLE EFFORTS to cause such Subcontractors to grant to AVENTIS or its
designee) such license and other rights are as reasonably necessary for AVENTIS
or its designee to perform such activities, including, without limitation, the
right to reference any approvals or filings of GENTA or its Subcontractors in
relation to API, BULK DRUG PRODUCT or FINISHED PRODUCT. (*). The Parties shall
promptly enter into such agreements and other documents as may be reasonably
necessary to document the aforesaid grant of license or other rights to AVENTIS
or its designee.
9.4 Transfer of Responsibility. Unless and until transfer of the TECHNICAL
INFORMATION for any specified PROCESSING ACTIVITIES has been transferred to
AVENTIS or its designee and AVENTIS shall have acknowledged in writing to GENTA
that AVENTIS or its designee is ready to assume responsibility for such
PROCESSING ACTIVITIES (such acknowledgment not to be unreasonably withheld),
GENTA shall remain responsible for such activity hereunder. Upon AVENTIS' or its
designee's assumption of such PROCESSING ACTIVITIES, GENTA shall be relieved
from its obligations hereunder as they apply to such activity and the Parties
shall in good faith amend this AGREEMENT to take into consideration AVENTIS' or
its designee's assumption of such PROCESSING ACTIVITIES.
9.5 Supply of Bulk Drug Product and/or API. Should AVENTIS take over any of
the PROCESSING ACTIVITIES such that GENTA would need to supply AVENTIS with BULK
DRUG PRODUCT and/or API in lieu of FINISHED PRODUCT, the provisions of this
AGREEMENT applicable to the supply of FINISHED PRODUCT to AVENTIS hereunder
shall instead apply to the supply of such BULK DRUG PRODUCT and/or API; and, if
GENTA supplies AVENTIS with API, the forecasting and firm order procedures set
forth in Section 4 of this AGREEMENT shall be modified appropriately to reflect
that fact.
(*) Represents language that is redacted and subject to Confidential Treatment.
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9.6 Other Agreements. Notwithstanding anything to the contrary in this
Section 9, AVENTIS' rights under this Section 9 to assume responsibility for any
PROCESSING ACTIVITIES shall be subject to the terms of the Commercialization
Agreements and the GENTA THIRD PARTY AGREEMENTS referenced therein.
9.7 HSR Compliance. To the extent AVENTIS assumes any PROCESSING ACTIVITIES
under this Section 9, the Parties shall review the situation to determine the
applicability or need for a Xxxx-Xxxxx-Xxxxxx filing, and shall coordinate their
efforts in relation thereto.
10. PRICING FOR FINISHED PRODUCT.
10.1 Calculation of Supply Price. The price for FINISHED PRODUCT supplied
by GENTA to AVENTIS other than under Section 4.5 above (the "Supply Price")
shall be GENTA's actual cost for such FINISHED PRODUCT as defined in this
Section 10.1.
10.1.1 API Production. The Supply Price shall include the
out-of-pocket amounts actually paid by GENTA to its Subcontractors for API used
to manufacture FINISHED PRODUCT supplied to AVENTIS hereunder. The Supply Price
shall also include reasonable testing, freight, warehousing and insurance costs
associated with API PRODUCTION and the shipment of API to the person or entity
responsible for FORMULATION AND FILLING, to the extent separately invoiced to
GENTA and not otherwise already built into the amounts charged to GENTA by such
Subcontractors.
10.1.2 Formulation and Filling. The Supply Price shall include the
out-of-pocket amounts actually paid by GENTA to its Subcontractors for
FORMULATION AND FILLING resulting in BULK DRUG PRODUCT that is used to
manufacture FINISHED PRODUCT supplied to AVENTIS hereunder. The Supply Price
shall also include reasonable testing, freight, warehousing and insurance costs
associated with FORMULATION AND FILLING and the shipment of BULK DRUG PRODUCT to
the person or entity responsible for FINAL PACKAGING (if necessary), to the
extent separately invoiced to GENTA and not otherwise already built into the
amounts charged to GENTA by such Subcontractors.
10.1.3 Final Packaging. The Supply Price shall include the
out-of-pocket amounts actually paid by GENTA to its Subcontractors for FINAL
PACKAGING of FINISHED PRODUCT supplied to AVENTIS hereunder. The Supply Price
shall also include reasonable testing and warehousing costs associated with
FINAL PACKAGING and the storage of FINISHED PRODUCT prior to its shipment to
AVENTIS or its designee, to the extent separately invoiced to GENTA and not
otherwise already built into the amounts charged to GENTA by such
Subcontractors.
10.1.4 Materials Sourcing. In the event GENTA separately purchases KEY
RAW MATERIALS or OTHER MATERIALS for use by its Subcontractors in the
manufacture of API, BULK DRUG PRODUCT and/or FINISHED PRODUCT, the Supply Price
shall include the out-of-pocket amounts actually paid by GENTA to THIRD PARTIES
for reasonable quantities of any such KEY RAW MATERIALS and OTHER MATERIALS that
are used in the manufacture of API, BULK DRUG PRODUCT and/or FINISHED PRODUCT
actually supplied
(*) Represents language that is redacted and subject to Confidential Treatment.
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to AVENTIS hereunder, to the extent the cost of such KEY RAW MATERIALS and OTHER
MATERIALS is not otherwise already built into the Supply Price. The Supply Price
shall also include reasonable testing, freight, warehousing and insurance costs
associated with acquiring, storing and using such KEY RAW MATERIALS or OTHER
MATERIALS and the shipment of such KEY RAW MATERIALS or OTHER MATERIALS to the
Subcontractor requiring them, to the extent separately invoiced to GENTA by
THIRD PARTIES.
10.1.5 Process Changes. To the extent GENTA is required to make any
out-of-pocket contribution (excluding any capital investment) in order to
implement any manufacturing process changes described and approved under Section
3.10 above (other than mandatory regulatory changes described in Section 10.8)
and GENTA is otherwise unable to recover such contribution (under Section 10.1.6
or otherwise), then GENTA, notwithstanding Section 10.1.8, shall be entitled to
recover one hundred percent (100%) of such out-of-pocket contribution by
maintaining the Supply Price in effect prior to such change until completing
such recovery, whereupon the Supply Price shall be reduced as otherwise set
forth in this Section 10.1
10.1.6 Supply Chain Management. The Supply Price shall include a
reasonable allocation for the specific internal costs and expenses of GENTA that
are required to directly support the manufacture of FINISHED PRODUCT, to the
extent not otherwise already built into the Supply Price or duplicating
activities performed by any Subcontractor. Examples of such activities include,
but are not necessarily limited to, supply chain production planning, the
formulation and placement of orders with Subcontractor, the management of
inventories throughout the supply chain process, quality control/quality
assurance, regulatory and Subcontractor oversight and cost accounting. GENTA and
AVENTIS shall mutually agree in good faith on such costs and expenses as well as
mechanisms for allocating such costs and expenses to the Supply Price. The
amount of resources utilized by GENTA in connection with carrying out these
support activities and the cost of such resources shall be proportional to the
volume and level of manufacturing activity. Should GENTA hire any third-party
contractors to conduct such activities on behalf of GENTA, the reasonable
out-of-pocket amounts paid by GENTA to such third-party contractors shall be
included in the Supply Price to the extent not otherwise already built into such
price or covering activities performed by any Subcontractor.
10.1.7 Related Party Transactions. Notwithstanding the foregoing, the
Supply Price shall exclude any amounts charged to GENTA by any related party
(including, without limitation, any joint venture entity) that are in excess of
the amounts that would have been charged to GENTA by an unrelated party in a
corresponding arms' length transaction; provided, however, that AVENTIS shall be
deemed to have accepted as an arm's length transaction any payment obligations
under an agreement approved in writing by AVENTIS or the SUPPLY CHAIN TEAM.
10.1.8 Recaptured Amounts. Notwithstanding the foregoing, the Supply
Price shall exclude any amounts charged to GENTA that have been recaptured by
GENTA which are attributable to FINISHED PRODUCT, BULK DRUG PRODUCT, API and/or
any other PROCESSING ACTIVITIES conducted hereunder, whether due to process
improvements, cost efficiencies or any other changed circumstances and
regardless of the manner in which such amounts are recaptured, including,
without limitation, amounts recaptured in the form of dividends, offsets,
retroactive price reductions, rebates, gain sharing payments, issuances of
(*) Represents language that is redacted and subject to Confidential Treatment.
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equity, loan forgiveness, payments based on late delivery of API or other
amounts paid to GENTA through any joint venture or by any other person or entity
(collectively, "Recaptured Amounts"). For clarification purposes, "Recaptured
Amounts" shall not include any amounts received by GENTA as repayment (with
interest at a commercial rate) for any capital, monies or consideration
previously provided by GENTA.
10.1.9 No Other Costs. Except as otherwise expressly permitted under
this AGREEMENT, the Supply Price shall exclude any amounts in addition to those
expressly permitted under this Section 10.1. Without limiting the foregoing, the
Supply Price shall exclude any assessments and recharges which cannot be
reasonably identified to a specific activity supporting the manufacture of
FINISHED PRODUCT and/or which are not in direct support of the manufacturing
process, such as charges for corporate management, corporate services or general
overhead, and any costs to GENTA for investment capital related to the
construction, startup, qualification or validation of any PROCESSING FACILITIES,
or financing costs related to the purchase or storage of any inventory of KEY
RAW MATERIALS or OTHER MATERIALS, API, BULK DRUG PRODUCT or FINISHED PRODUCT.
10.1.10 Subcontractor Decisionmaking. GENTA shall obtain AVENTIS' or
the SUPPLY CHAIN TEAM's approval before GENTA takes any actions within its
control or discretion under any Subcontractor Agreement that would have the
effect of materially increasing (or, if applicable, not materially reducing
where such reduction is available) the Supply Price. To the extent GENTA
violates the foregoing sentence without having obtained AVENTIS' or the SUPPLY
CHAIN TEAM's approval, and AVENTIS does not reasonably believe such action was
reasonable, then the incremental amounts charged to GENTA on account thereof
shall be excluded from the Supply Price.
10.1.11 Other Subcontractor Relationships. If GENTA establishes a
joint venture or other similar relationship with a Subcontractor in order to
conduct any of the PROCESSING ACTIVITIES, and if GENTA and such Subcontractor,
through such joint venture or other similar relationship, also offer to sell
products or services to THIRD PARTIES, GENTA agrees not to utilize such joint
venture or other similar relationship in a manner that is intended to
disadvantage the Supply Price in order to benefit sales or prices of other
products or sales offered for sale by GENTA to such THIRD PARTIES (including
without limitation disproportionately allocating costs or benefits in favor of
such other products).
10.2 Forecasted Supply Price. Within forty-five (45) days following the
Effective Date, the Parties shall calculate a forecasted per-unit Supply Price
for FINISHED PRODUCT, BULK DRUG PRODUCT and/or API that shall apply for the
remainder of CALENDAR YEAR 2002. At least three (3) months prior to the
beginning of each subsequent CALENDAR YEAR, the Parties shall calculate a
forecasted per-unit Supply Price for FINISHED PRODUCT, BULK DRUG PRODUCT and/or
API that shall apply for such CALENDAR YEAR. Such forecasted per-unit Supply
Price for the remainder of CALENDAR YEAR 2002 and for each subsequent CALENDAR
YEAR shall be referred to herein as the "Forecasted Supply Price." The
Forecasted Supply Price for FINISHED PRODUCT, BULK DRUG PRODUCT and/or API shall
be a good faith estimate of what the Parties believe the average per-unit Supply
Price will be for FINISHED PRODUCT, BULK DRUG PRODUCT and/or API supplied to
AVENTIS for such CALENDAR YEAR, and shall take into consideration any actual or
anticipated process
(*) Represents language that is redacted and subject to Confidential Treatment.
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improvements, cost efficiencies or other changes that are likely to have an
impact on the Supply Price for such CALENDAR YEAR. Unless otherwise agreed by
the Parties, AVENTIS shall be invoiced at the Forecasted Supply Price for all
FINISHED PRODUCT, BULK DRUG PRODUCT and/or API supplied by GENTA during such
CALENDAR YEAR, subject to the true-up in Section 10.3.
10.3 True-Up of Supply Price. Within fifteen (15) days following the end of
the first and last semi-annual period of each CALENDAR YEAR (i.e., within 15
days after June 30 and December 31 of each CALENDAR YEAR), GENTA shall provide
AVENTIS a preliminary report estimating the following: (i) GENTA's calculation
of the actual Supply Price for each shipment of FINISHED PRODUCT, BULK DRUG
PRODUCT and/or API supplied to AVENTIS during such semi-annual period (the
"Actual Shipment Supply Price"), which calculation shall include a reasonably
detailed breakdown of the components of the Actual Shipment Supply Price,
including, without limitation, the items described in Section 10.1.6, (ii) the
amount by which the Forecasted Supply Price exceeded or was less than the Actual
Shipment Supply Price for such shipment (the "Shipment Supply Price Deviation"),
and (iii) a reconciliation of all of the Shipment Supply Price Deviations for
such semi-annual period, with separate reconciliations for both AVENTIS US and
AVENTIS IRELAND, so as to determine a single amount that either GENTA or AVENTIS
US is required to pay to the other, and a single amount that either GENTA or
AVENTIS IRELAND is required to pay to the other, by reason of such
reconciliations resulting in Shipment Supply Price Deviations that are positive
or negative. To the extent that volume estimates are needed for such
calculation, annualized volumes shall be utilized. Amounts required to be paid
shall be paid by the Party or Parties owing them to the Party or Parties
entitled to receive them in accordance with the provisions of Section 11.3
below. Within forty-five (45) days following the end of the first and last
semi-annual period of each CALENDAR YEAR (i.e., within 45 days after June 30 and
December 31 of each CALENDAR YEAR), GENTA shall provide AVENTIS with a written
report including GENTA's final determination of the figures set forth in the
preliminary report referenced above.
10.4 Subsequent Adjustments. Should GENTA obtain the benefit of any
Recaptured Amounts for a particular semi-annual period following the true-up
described in Section 10.3 above, GENTA shall immediately notify AVENTIS thereof.
Such Recaptured Amounts shall, at AVENTIS' option, be passed through to AVENTIS
as part of the next succeeding true-up of the Supply Price under Section 10.3
above, or in the form of an immediate payment to AVENTIS.
10.5 Process Improvements and Cost Efficiencies. GENTA shall be committed
to developing and implementing, and shall use COMMERCIALLY REASONABLE EFFORTS to
cause its Subcontractors to commit to develop and implement, continuous cost,
quality and customer service improvement programs by seeking productivity
improvements, by minimizing waste and improving yields, by purchasing quality
materials at lower cost, by improving manufacturing processes, by streamlining
organizational processes, by reducing cycle times and lead times and the like,
and through such other means as the SUPPLY CHAIN TEAM shall mandate from time to
time. At the end of each CALENDAR YEAR, the Parties, in coordination with the
SUPPLY CHAIN TEAM, shall meet to discuss and set targets and goals of cost
reductions and quality and customer service improvements for the following
CALENDAR YEAR.
(*) Represents language that is redacted and subject to Confidential Treatment.
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10.6 Competitive Pricing. GENTA shall use COMMERCIALLY REASONABLE EFFORTS
to ensure the most competitive Supply Price for FINISHED PRODUCT relative to
other products of similar quantity and quality. In this regard, GENTA shall use
COMMERCIALLY REASONABLE EFFORTS to obtain such competing price quotes and
conduct such benchmarking studies with respect to the PROCESSING ACTIVITIES as
the SUPPLY CHAIN TEAM shall reasonably request from time to time. If AVENTIS or
the SUPPLY CHAIN TEAM are able to find an alternative supplier that would
provide FINISHED PRODUCT or its components at a price that is at least (*) less
than the current price, then GENTA, in coordination with the SUPPLY CHAIN TEAM,
shall use COMMERCIALLY REASONABLE EFFORTS to either have its existing
Subcontractors match the lower price, or take steps to change such
Subcontractors to achieve the most competitive price for similar quantities and
quality of FINISHED PRODUCT or such components.
10.7 GENTA Internal Assumption of Processing Activities. To the extent that
GENTA desires to undertake any of the PROCESSING ACTIVITIES internally as
opposed to through Subcontractors, GENTA shall provide the SUPPLY CHAIN TEAM
with written notice thereof. Thereupon, the Parties, in coordination with the
SUPPLY CHAIN TEAM, shall evaluate GENTA's request and, if appropriate, establish
a plan for GENTA to so undertake such activities. In such event, the Parties
shall in good faith adjust the terms of this AGREEMENT, including the method of
calculating the Supply Price, to take into consideration GENTA's internal
assumption of such PROCESSING ACTIVITIES. Said adjustment shall be designed to
permit GENTA to recover its standard costs associated with such PROCESSING
ACTIVITIES, which standard costs shall be those normally be capitalized as
inventoriable costs under generally accepted accounting principles, consistently
applied.
10.8 Regulatory Changes. To the extent GENTA is required to make any
out-of-pocket contribution (excluding any capital investment) in order to
implement any mandatory regulatory changes described under Section 3.10 and
GENTA is otherwise unable to recover (*) of such contribution, then GENTA shall
be entitled to recover of such contribution. GENTA shall invoice AVENTIS for
such contribution at the end of the CALENDAR QUARTER during which such change
first becomes effective and AVENTIS shall pay such invoiced amount in accordance
with the provisions of Section 11.3.
10.9 (*).
10.9.1 (*)
(a) (*)
(b) (*)
(*) Represents language that is redacted and subject to Confidential Treatment.
- 26 -
(*)
(c) (*)
(d) (*)
(e) (*)
10.9.2 (*)
10.9.3 (*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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(*)
10.9.4 (*)
10.9.5 (*)
10.9.6 (*)
10.10 Supply in (*) Countries. If (*) or more of the total volume of
FINISHED PRODUCT, BULK PRODUCT and API (on a unit basis) manufactured and
supplied to AVENTIS under this AGREEMENT is being supplied to countries outside
of the U.S. for which GENTA's royalty payment is (*) under the Ex-U.S.
Commercialization Agreement, then in addition to the amounts owed by AVENTIS to
GENTA under this AGREEMENT, AVENTIS IRELAND shall pay to GENTA for all FINISHED
PRODUCT, BULK PRODUCT and API manufactured hereunder for supply to such
countries, the greater of (i) (*) of the average Supply Price paid by AVENTIS
for FINISHED PRODUCT, BULK PRODUCT and/or API (after taking into consideration
all adjustments under Section 10.3 and Section 10.4), and (ii) (*) of the ANNUAL
NET SALES for such country. Within forty-five (45) days following the end of the
first and last semi-annual
(*) Represents language that is redacted and subject to Confidential Treatment.
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period of each CALENDAR YEAR (i.e., within 45 days after June 30 and December 31
of each CALENDAR YEAR), AVENTIS IRELAND shall provide GENTA a report reasonably
detailing AVENTIS IRELAND's calculation of any additional amounts payable to
GENTA by reason of this Section 10.10. Said amounts shall be paid by AVENTIS
IRELAND to GENTA in accordance with the provisions of Section 11.3 below.
10.11 Samples. For clarification purposes, AVENTIS shall pay GENTA the
Supply Price for any samples or any other Free Product (as defined in Section
10.2.3 of the U.S. Commercialization Agreement) provided pursuant to this
AGREEMENT.
11. PAYMENTS; REPORTING; BOOKS AND RECORDS.
11.1 Payment Method. All payments under this AGREEMENT shall be made by
bank wire transfer in immediately available funds to an account designated by
the Party to which such payments are due. Any payments due under this AGREEMENT
which are not paid by the date such payments are due under this AGREEMENT shall
bear interest to the extent permitted by applicable law at a rate equal to the
thirty (30) day London Inter-Bank Offering Rate ("LIBOR") U.S. Dollars, as
quoted in The Financial Times effective for the date on which the payment was
due. This Section 11.1 shall in no way limit any other remedies available to the
Parties.
11.2 U.S. Dollars. All sums due under this AGREEMENT shall be payable in
U.S. Dollars.
11.3 Invoices; Timing of Payments. GENTA shall invoice AVENTIS US or
AVENTIS IRELAND, as applicable, for all FINISHED PRODUCT supplied hereunder on
the date of shipment, and for all other amounts due to GENTA hereunder monthly
in arrears. Each invoice shall specify the Purchase Order number to which it
corresponds. Unless otherwise specified in this AGREEMENT, all amounts due to
GENTA hereunder shall be paid by AVENTIS US or AVENTIS IRELAND, as applicable,
within thirty (30) days following the date of receipt of invoice.
Notwithstanding the foregoing, all amounts payable by a Party under Section
10.3, Section 10.9 and Section 10.10 above shall be paid within sixty (60) days
following the end of the applicable semi-annual period or CALENDAR YEAR;
provided, however, that the Parties shall endeavor to establish such mechanisms
as may be reasonably necessary to permit them to reconcile the amounts payable
under Section 10.3, Section 10.9 and Section 10.10 into two payments: one
between GENTA and AVENTIS US and one between GENTA and AVENTIS IRELAND.
11.4 Sales Tax. Upon demand, AVENTIS US and AVENTIS IRELAND shall indemnify
GENTA from and shall hold GENTA harmless against any payment, assessment,
billing, or other imposition of any sales, use, consumption, value-added or
excise taxes or assessments which may be imposed by any GOVERNMENTAL AUTHORITY
and any penalties, interest, fines or fees against GENTA which are or shall
become due from GENTA as a result of the sale of FINISHED PRODUCT, BULK DRUG
PRODUCT or API to AVENTIS US or AVENTIS IRELAND and all such taxes or
assessments which GENTA shall be obligated to collect or AVENTIS US and AVENTIS
IRELAND, as the case may be, shall execute an appropriate sales exemption
certificate, if applicable. At its sole expense, AVENTIS US or AVENTIS IRELAND,
as the case may be, may defend against the imposition of any such taxes
(*) Represents language that is redacted and subject to Confidential Treatment.
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which it is or may be held obligated by law to pay. GENTA shall promptly notify
AVENTIS US or AVENTIS IRELAND, as the case may be, of any such tax or assessment
that any GOVERNMENTAL AUTHORITY is seeking to collect from GENTA and AVENTIS US
or AVENTIS IRELAND, as the case may be, may assume the defense thereof at its
sole expense.
11.5 Suspension of Performance. In the event that AVENTIS US or AVENTIS
IRELAND, as applicable, does not pay GENTA any material invoiced amounts due
hereunder that are not then-being reasonably disputed by AVENTIS in good faith
for sixty (60) days following the due date, GENTA shall have the right to
suspend its provision of further shipments of FINISHED PRODUCT pending its
receipt of the unpaid amounts or portion thereof.
11.6 Audit Rights. Each Party shall keep, and require its AFFILIATES and,
in the case of GENTA, its Subcontractors 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. Such books and records shall be kept at the
principal place of business of each Party, its AFFILIATES and such
Subcontractors for at least five (5) years following the end of the calendar
quarter to which they pertain. Such records will be open for inspection during
such five (5) year period by an independent auditor chosen by the other Party
and reasonably acceptable to both Parties for the purpose of verifying the
amounts payable hereunder. Such inspections may be made no more than once each
CALENDAR YEAR, at reasonable times and on reasonable notice and once the records
for a period are audited they shall not be subject to re-audit. The independent
auditor shall be obligated to execute a reasonable confidentiality agreement
prior to commencing any such inspection. Inspections conducted under this
Section 11.6 shall be at the expense of the auditing Party, unless a variation
or error producing an underpayment in amounts payable exceeding five percent
(5%) of the amount paid for the entire period covered by the inspection is
established in the course of any such inspection, whereupon all reasonable
out-of-pocket costs relating to the inspection for such period (up to the amount
of the underpayment) and any unpaid amounts that are discovered shall be paid by
the audited Party, together with interest on such unpaid amounts at the rate set
forth in Section 11.1 above. The Parties will endeavor to minimize disruption of
the audited Party's normal business activities to the extent reasonably
practicable.
12. CONFIDENTIALITY.
12.1 Nondisclosure. "Confidential Information" means any information, data,
or know-how which the disclosing Party treats confidentially and identifies as
confidential or which the recipient knows or should have reason to believe is so
treated. Each Party shall not (and shall require that its AFFILIATES and, in the
case of GENTA, its Subcontractors 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
GENTA, its Subcontractors, on a need-to-know basis only, and such Party shall be
responsible for its AFFILIATES' and, in the case of GENTA, its Subcontractors,
compliance with the provisions of this Section 12 with respect thereto. Each
Party shall take (and shall require its AFFILIATES and, in the case of GENTA,
its Subcontractors to take) reasonable steps to prevent any unauthorized use or
disclosure of the
(*) Represents language that is redacted and subject to Confidential Treatment.
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other Party's Confidential Information to THIRD PARTIES. The obligations of
confidentiality under this Section shall remain in effect until the later of
five (5) years after any termination of the term of this AGREEMENT, or fifteen
(15) years following the Effective Date.
12.2 Exceptions. The confidentiality obligations in this Section 12 shall
not apply to information which (a) is or becomes a matter of public knowledge
through no fault of the receiving Party or any person to whom the receiving
Party provided such information, or (b) is or was already in the possession of
the receiving Party at the time of disclosure by the disclosing Party, or (c) is
disclosed to the receiving Party by a THIRD PARTY having the right to do so, or
(d) is subsequently and independently developed by or on behalf of the receiving
Party or its AFFILIATES by persons having no access to the disclosing Party's
Confidential Information, (e) is reasonably required to be disclosed in
connection with obtaining or maintaining MAA APPROVALS for PRODUCT, or (f) is
required by law to be disclosed, provided that the receiving Party 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.
12.3 Terms of Agreement. Except as set forth below, no announcement or
other disclosure, public or otherwise, concerning the financial or other terms
of this AGREEMENT shall be made, either directly or indirectly, by any Party to
this AGREEMENT, except as may be legally required, without first obtaining the
written approval of the other Party and agreement upon the nature and text of
such announcement or disclosure, such approval and agreement not to be
unreasonably withheld. The Party desiring to make any announcement or other
disclosure concerning the terms of this AGREEMENT shall provide the other Party
with a copy of the proposed announcement or disclosure for review and comment in
reasonably sufficient time prior to undertaking the announcement or disclosure.
Each Party agrees that it shall reasonably cooperate with the other with respect
to all disclosures regarding this AGREEMENT to the Securities Exchange
Commission and any other governmental or regulatory agencies. In addition, the
Parties will coordinate in advance with each other on the terms of this
AGREEMENT that the Parties shall seek to be redacted in any SEC filings, and
each Party shall use reasonable efforts to seek confidential treatment for such
terms, provided that each Party shall ultimately retain control over what
information to disclose to the SEC or any other such agencies. The Parties will
mutually agree upon the contents of a joint press release (and accompanying Q&A)
which shall be issued simultaneously by both Parties upon the Effective Date.
Notwithstanding the above, the Parties shall be free to publicly disclose
information contained in such press release or Q&A, or in any other materials
that have been previously approved for disclosure by the other Party, without
further approvals from the other Party hereunder, to the extent there have been
no material additions or changes thereto.
13. INTELLECTUAL PROPERTY AND TRADEMARKS.
13.1 Third-Party Materials. GENTA shall refrain from, and shall use
COMMERCIALLY REASONABLE EFFORTS to require each Subcontractor to refrain from,
knowingly (i) incorporating any materials that are proprietary to, or that are
manufactured using any proprietary process of, any THIRD PARTY into any FINISHED
PRODUCT supplied to AVENTIS hereunder; or (ii) designing any process for the
manufacture of KEY RAW
(*) Represents language that is redacted and subject to Confidential Treatment.
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MATERIALS, API, BULK DRUG PRODUCT or FINISHED PRODUCT so as to require the use
of any proprietary materials or processes of any THIRD PARTY, in either case
without the prior written consent of the SUPPLY CHAIN TEAM, except that such
consent shall not be necessary to the extent that sufficient rights for AVENTIS
to utilize such materials and processes have been granted by GENTA to AVENTIS in
the Commercialization Agreements.
13.2 Trademark and Use of Names. GENTA shall require its Subcontractors to
agree not to use any trademark or trade name of AVENTIS in any advertising
material or sales literature without the prior written consent of AVENTIS.
14. TERM AND TERMINATION.
14.1 Expiration. This AGREEMENT shall continue in full force and effect,
unless earlier terminated as set forth in Section 14.2, through the date one (1)
year after the expiration or termination of both of the Commercialization
Agreements, provided that if only one such agreement is terminated, then GENTA's
obligations hereunder shall apply only with respect to such remaining agreement.
Notwithstanding the foregoing, this AGREEMENT shall automatically expire if and
when AVENTIS or its designees assume responsibility for all of the PROCESSING
ACTIVITIES pursuant to Section 9 above.
14.2 Termination. Upon at least one (1) year's prior written notice to
AVENTIS given no earlier than the expiration of the GENTA G3139 PATENT RIGHTS,
GENTA shall be permitted to terminate this AGREEMENT if (i) AVENTIS is no longer
commercializing the PRODUCT in any MAJOR COUNTRY, or (ii) AVENTIS could
otherwise have the PRODUCT manufactured and supplied to it at or below the
average Supply Price being paid by AVENTIS to GENTA hereunder for FINISHED
PRODUCT (factoring in a fair depreciation for reasonable upfront costs of
transferring the manufacturing process). Except in accordance with the
provisions of the Commercialization Agreements or as set forth above, neither
Party may terminate this AGREEMENT prior to its expiration. Notwithstanding the
foregoing sentence, if GENTA fails to fill all or substantially all of AVENTIS'
Firm Orders with FINISHED PRODUCT (or, if applicable BULK DRUG PRODUCT or API)
that conforms to the SPECIFICATIONS for a period of three (3) consecutive
CALENDAR MONTHS, and such failure is not due primarily to the fault of AVENTIS,
AVENTIS, without limiting any other rights or remedies that may be available to
it, shall have the right to terminate this AGREEMENT immediately upon written
notice to GENTA, with such termination resulting in the automatic and immediate
termination of the Commercialization Agreements for what shall be deemed a
material breach or default by GENTA.
15. RIGHTS AND DUTIES UPON TERMINATION.
15.1 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.
(*) Represents language that is redacted and subject to Confidential Treatment.
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15.2 Return of Materials. Within sixty (60) days following the date on
which AVENTIS ceases marketing or selling PRODUCT as permitted under the
Commercialization Agreements, 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.
15.3 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: 2.2, 3.12, 6.3, 6.4, 9.2, 9.3,
9.6, 11.4, 11.6, 12.1-12.3, 15.1-15.4, 16.3-16.6, 17.1, 17.3-17.7, and
17.9-17.14.
15.4 Other. It is understood that termination or expiration of this
AGREEMENT shall not relieve a Party from any liability which, at the time of
such termination or expiration, has already accrued to the other Party or which
is attributable to a period prior to such termination. Termination or expiration
of the AGREEMENT in accordance with the provisions hereof shall not limit
remedies which may be otherwise available in law or equity with respect to a
breach hereof that occurred prior to such termination.
16. WARRANTIES AND REPRESENTATIONS, INDEMNIFICATION AND INSURANCE.
16.1 General Representations. The representations and warranties of each of
the Parties under the Commercialization Agreements are hereby incorporated into
this Section 16.1 by reference.
16.2 GENTA Additional Representations, Warranties and Covenants. GENTA
hereby represents, warrants, covenants and agrees as follows:
16.2.1 GENTA and its Subcontractors shall perform all PROCESSING
ACTIVITIES and maintain all PROCESSING FACILITIES in accordance with cGMPs, the
SPECIFICATIONS, the QUALITY AGREEMENT, all applicable REGULATORY STANDARDS and
other requirements of any GOVERNMENTAL AUTHORITY, and such quality assurance and
quality control practices as are standard in the pharmaceutical manufacturing
industry.
16.2.2 All FINISHED PRODUCT shipped to or at the direction of AVENTIS
under this AGREEMENT shall, at the time of delivery, (i) meet the
SPECIFICATIONS; and (ii) have been processed and maintained in conformance with
cGMPs and all other applicable REGULATORY STANDARDS.
16.2.3 All FINISHED PRODUCT manufactured and supplied hereunder shall
not be: (i) adulterated or misbranded within the meaning of the Federal Food,
Drug and Cosmetic Act, as amended (the "FFDCA"), or any foreign, state or local
counterparts thereof; or (ii) manufactured in violation of any applicable
federal, state or local laws or regulations, in either the United States or any
foreign jurisdiction.
(*) Represents language that is redacted and subject to Confidential Treatment.
- 33 -
16.2.4 To the best of GENTA's knowledge, neither GENTA, its
Subcontractors or their respective AFFILIATES, nor any members of their
respective staffs, are involved in performance of any PROCESSING ACTIVITIES, nor
shall they be, at the time of performance of any PROCESSING ACTIVITIES
hereunder, (i) disqualified or debarred by the FDA or any other REGULATORY
AUTHORITY for any purpose pursuant to 21 U.S.C. ss. 355a or any foreign
counterparts thereof; or (ii) charged with or convicted under United States
federal law, or foreign counterparts thereof, for conduct relating to the
development or approval of, or otherwise relating to the regulation of, any drug
product under the Generic Drug Enforcement Act of 1992 or any other relevant
statute, law or regulation.
16.2.5 Except as set forth in Schedule 16.2.5, to GENTA's actual
knowledge as of the Effective Date, neither (*), nor (*) nor (*) is currently
utilizing in conducting any PROCESSING ACTIVITIES or shall reasonably be
required to utilize in conducting any PROCESSING ACTIVITIES, any material
processes, reagents or other materials COVERED by any PATENT RIGHTS of such
Subcontractor or any THIRD PARTY (but excluding any PATENT RIGHTS to which
AVENTIS has been granted license rights under the Commercialization Agreements
and excluding any processes, reagents or other materials generally available to
the public for purchase or license). As used herein, the terms "COVERED" and
"PATENT RIGHTS" shall have the meanings ascribed to them under the
Commercialization Agreements.
16.3 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 API, BULK DRUG PRODUCT AND FINISHED PRODUCT
AND THE MANUFACTURE AND SUPPLY THEREOF), INCLUDING, WITHOUT LIMITATION, ANY
IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A
PARTICULAR PURPOSE.
16.4 Indemnification. The indemnification provisions of the
Commercialization Agreements shall apply to claims for indemnification under or
with respect to this AGREEMENT.
16.5 Limitation of Liability. EXCEPT FOR ANY WILLFUL BREACH BY EITHER PARTY
OF ITS REPRESENTATIONS, WARRANTIES, COVENANTS OR AGREEMENTS UNDER SECTION 16.1
OR SECTION 16.2 ABOVE, OR FOR DAMAGES ACTUALLY PAID BY A PARTY TO A THIRD PARTY
PURSUANT TO A THIRD-PARTY CLAIM, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE
OTHER OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT,
SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST
PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS
AFFILIATES IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY
OF SUCH DAMAGES. THIS LIMITATION SHALL SURVIVE ANY FAILURE OF THE ESSENTIAL
PURPOSE OF A LIMITED OR EXCLUSIVE REMEDY SET FORTH HEREIN.
(*) Represents language that is redacted and subject to Confidential Treatment.
- 34 -
16.6 Subcontractor Acts and Omissions. SUBJECT TO THE EXPRESS PROVISIONS OF
THIS AGREEMENT, GENTA SHALL HAVE NO LIABILITY TO AVENTIS FOR ANY DAMAGES
RESULTING FROM ACTS OR OMISSIONS OF ANY SUBCONTRACTOR THAT ARE NOT PRIMARILY
ATTRIBUTABLE TO A BREACH BY GENTA OF ITS OBLIGATIONS UNDER THIS AGREEMENT, AND
THAT COULD NOT REASONABLY HAVE BEEN PREVENTED BY GENTA THROUGH THE EXERCISE OF
REASONABLE CARE, EXCEPT TO THE EXTENT GENTA ACTUALLY RECOVERS DAMAGES FROM SUCH
SUBCONTRACTOR ON ACCOUNT OF SUCH ACTS OR OMISSIONS, IN WHICH CASE GENTA'S
LIABILITY TO AVENTIS FOR ANY DAMAGES WITH RESPECT THERETO SHALL NOT EXCEED THE
AMOUNTS ACTUALLY RECOVERED BY GENTA FROM SUCH SUBCONTRACTOR.
17. GENERAL PROVISIONS.
17.1 Approvals. All approvals required by a Party hereunder shall not be
unreasonably withheld or delayed. Once a Subcontractor or Subcontractor
Agreement has been approved by the SUPPLY CHAIN TEAM under this AGREEMENT, no
further approvals of the SUPPLY CHAIN TEAM shall be required for immaterial
changes thereto. (*).
17.2 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, including without limitation, any
acts or restraints of governments or public authorities or compliance with any
order or regulation of any government entity acting with color of right, war,
terrorism, sabotage, revolution, riot or civil commotion, strikes, lock-outs,
failure of supplies of power, fuel, transport, prohibitions against imports or
exports of API, impossibility of obtaining KEY RAW MATERIALS or a force majeure
event affecting a supplier of KEY RAW MATERIALS that results in a shortage of
supply of KEY RAW MATERIALS, explosion, fire, flood, natural disaster or an act
of God, each to the extent the same are beyond the reasonable control of the
affected Party (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
(*) Represents language that is redacted and subject to Confidential Treatment.
- 35 -
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.
17.3 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.
17.4 Waiver of Breach. The failure of either Party at any time or times to
require performance of any provision hereof shall in no manner affect its rights
at a later time to enforce the same. No waiver by either Party of any condition
or term in any one or more instances shall be construed as a further or
continuing waiver of such condition or term or of another condition or term.
17.5 Severability. In the event any portion of this AGREEMENT shall be held
illegal, void or ineffective, the remaining portions hereof shall remain in full
force and effect and the Parties will in good faith endeavor to renegotiate the
terms and conditions of this AGREEMENT to resolve any inequities. If a Party
seeks to avoid a provision of this AGREEMENT by asserting that such provision is
invalid, illegal or otherwise unenforceable, such action shall be deemed a
material breach of this AGREEMENT.
17.6 Entire Agreement. This AGREEMENT, together with the Exhibits and
attachments hereto and the other agreements between the Parties referred to
herein, constitute the entire agreement between the Parties relating to the
subject matter hereof and thereof and supersede all previous writings and
understandings with respect to such subject matter. No terms or provisions of
this AGREEMENT shall be varied or modified by any prior or subsequent statement,
conduct or act of either of the Parties, except that the Parties may amend this
AGREEMENT by written instruments specifically referring to and executed in the
same manner as this AGREEMENT. The provisions of this AGREEMENT shall supersede
the provisions of the confidentiality/non-disclosure agreement previously
entered into by the Parties, provided that information or materials deemed
"Confidential Information" under such agreement shall henceforth be treated as
"Confidential Information" under this AGREEMENT.
17.7 Notices. Any notice required or permitted under this AGREEMENT shall
be sent by overnight delivery using a reputable overnight delivery service,
postage pre-paid, to the following addresses of the Parties, or to such other
addresses as the Parties may from time to time provide by a notice given
hereunder:
(*) Represents language that is redacted and subject to Confidential Treatment.
- 36 -
AVENTIS US
Aventis Pharmaceuticals Inc.
Vice President, Legal Corporate Development
000 Xxxxxxxx Xxxxxxxxx
Xxxxxxxxxxx, Xxx Xxxxxx 00000-0000
Attn: Xxxxxxx X. Xxxxxx, Esq.
copies to:
Xxxxxx, Xxxxx & Bockius LLP
000 Xxxxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Attn: Xxxxx Xxxxxx, Esq.
AVENTIS IRELAND
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.
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.
17.8 (*)
(*) Represents language that is redacted and subject to Confidential Treatment.
- 37 -
(*)
17.9 No Partnership or Joint Venture. Each Party shall bear its own costs
incurred in the performance of its obligations hereunder without charge or
expense to the other Party, except as expressly provided in this AGREEMENT.
Neither Party shall have any authority to bind or obligate the other Party to
this AGREEMENT for any sum or in any manner whatsoever, or to create or impose
any contractual or other liability on the other Party without the other Party's
prior approval. For all purposes, and notwithstanding any other provision of
this AGREEMENT to the contrary, each Party's legal relationship with the other
under this AGREEMENT shall be that of an independent contractor, and this
AGREEMENT shall not be deemed to establish a joint venture or partnership
between AVENTIS and GENTA.
17.10 No Third-Party Beneficiaries. None of the provisions of this
AGREEMENT shall be for the benefit of or enforceable by any THIRD PARTY,
including without limitation any creditor of either Party hereto. No such THIRD
PARTY shall obtain any right under any provision of this AGREEMENT or shall by
reasons of any such provision make any CLAIM in respect of any debt, liability
or obligation (or otherwise) against either Party hereto.
17.11 Non-Solicitation. During the term of this AGREEMENT and for two (2)
years thereafter, a Party may not actively solicit an employee of the other
Party to leave the employment of the other Party and accept employment with the
first Party. Active solicitation shall not be deemed to include general
advertisement not directed specifically to any employee or class of employees of
the other Party.
17.12 Specific Performance. Each of the Parties acknowledges and agrees
that the other Party would be damaged irreparably in the event any of the
provisions of this AGREEMENT are not performed in all material respects or
otherwise are breached. Accordingly, and notwithstanding anything herein to the
contrary, each of the Parties agree that the other Party shall be entitled to
injunctive relief to prevent breaches of the provisions of this AGREEMENT,
and/or to enforce specifically this AGREEMENT and the terms and provisions
hereof, in any action instituted in any court or tribunal having jurisdiction
over the Parties and the matter, without posting any bond or other security, and
that such injunctive relief shall be in addition to any other remedies to which
such Party may be entitled, at law or in equity.
17.13 Further Assurances. Each Party shall execute, acknowledge and deliver
such further instruments, and shall do all such other acts as may be necessary
or appropriate, in order to carry out the purposes and intent of this AGREEMENT.
(*) Represents language that is redacted and subject to Confidential Treatment.
- 38 -
17.14 Execution in Counterparts. This AGREEMENT may be executed in any
number of counterparts, each of which shall be deemed an original but all of
which together shall constitute one and the same instrument.
[Remainder of this page intentionally blank]
(*) Represents language that is redacted and subject to Confidential Treatment.
- 39 -
IN WITNESS WHEREOF, GENTA, AVENTIS US and AVENTIS IRELAND, by their duly
authorized officers, have executed this AGREEMENT as of the Effective Date.
GENTA INCORPORATED
By:_____________________________________
Name: Xxxxxxx X. Xxxxxxx, Xx., M.D.
Title: Chairman & Chief Executive
Officer
AVENTIS PHARMACEUTICALS INC.
By:_____________________________________
Name: Xxxxxx X. Belle
Title: President and Chief Executive
Officer
GARLISTON LIMITED
By:_____________________________________
Name:
Title:
(*) Represents language that is redacted and subject to Confidential Treatment.
- 40 -
EXHIBIT 1.1
ACTIVE INGREDIENT
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.
- 41 -
Structure of G3139 Sodium Salt
[GRAPHIC OMITTED]
17 Na+
(*) Represents language that is redacted and subject to Confidential Treatment.
- 42 -
EXHIBIT 1.27
PRODUCT
Trade Name: Genasense(TM) Injection.
Description: Sterile solution of oblimersen sodium (30 mg/mL free acid form) in
0.9% saline, pH 7.2, in a 10 cc glass vial containing at least 10 mL of drug
product, stored at 2-8(degree)C.
(*) Represents language that is redacted and subject to Confidential Treatment.
- 43 -
EXHIBIT 1.28
ISSUES FOR QUALITY AGREEMENT
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
- 44 -
(*)
* Based on Genta's quality control data.
(*) Represents language that is redacted and subject to Confidential Treatment.
- 45 -
EXHIBIT 1.31
SPECIFICATIONS
G3139 DRUG SUBSTANCE (API) IND SPECIFICATIONS*
----------------------------- -----------------------------
Test Acceptance Criteria
----------------------------- -----------------------------
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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G3139 DRUG PRODUCT (BULK DRUG PRODUCT) IND SPECIFICATIONS*
----------------------------- -----------------------------
Test Acceptance Criteria
----------------------------- -----------------------------
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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EXHIBIT 2.3
APPROVED SUBCONTRACTORS
Subcontractor Processing Activity Processing Facility
------------- ------------------- -------------------
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
- 48 -
SCHEDULE 10.9
(*)
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
- 49 -
SCHEDULE 16.2.5
SCHEDULE OF EXCEPTIONS
(*)
(*) Represents language that is redacted and subject to Confidential Treatment.
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