Exhibit 10.11

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PRODUCT KNOW-HOW LICENSE AGREEMENT

among

SANOFI

BRISTOL-MYERS SQUIBB COMPANY

and

BRISTOL-MYERS SQUIBB SANOFI PHARMACEUTICALS HOLDING PARTNERSHIP

dated as of January 1, 1997

 

 

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TABLE OF CONTENTS

 

ARTICLE 1

DEFINITIONS

SECTION 1.1    Defined Terms    2 SECTION 1.2    Additional Defined Terms    5

ARTICLE 2

GRANT OF LICENSE

SECTION 2.1    License Giant    5 SECTION 2.2    No Transfer    6 SECTION 2.3   
No Implicit Rights    6 SECTION 2.4    Corporate Name Authorization    6 SECTION
2.5    Goodwill    6 SECTION 2.6    Representations and Warranties    6 SECTION
2.7    Improvements    6

ARTICLE 3

SUB-LICENSE

SECTION 3.1    General Sub-License    6 SECTION 3.2    Sub-License for Alliance
Agreements    7 SECTION 3.3    Termination of Sub-License    7

ARTICLE 4

PROVISION OF DOCUMENTS

SECTION 4.1    Initial Exchange    7 SECTION 4.2    Continuing Exchange    7

ARTICLE 5

CONSIDERATION

SECTION 5.1    Development Royalty    7 SECTION 5.2    Payment    8 SECTION 5.3
   Method of Payment    8 SECTION 5.4    Records    8 SECTION 5.5    Payment
Reports    8 SECTION 5.6    Taxes    8

 

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ARTICLE 6

LICENSE STEERING COMMITTEE

SECTION 6.1    License Steering Committee    9

SECTION 6.2

   License Functional Committees    9 SECTION 6.3    Marketing Working Group   
9 SECTION 6.4    Development Committee    10 SECTION 6.5    Regulatory Committee
   10 SECTION 6.6    Committee Composition and Decision Making    10 SECTION 6.7
   Committee Dispute Resolution    11 SECTION 6.8    Cross-Territory Issues   
11 SECTION 6.9    Delegation    11

ARTICLE 7

NEW INDICATION OR LINE EXTENSION

SOLE RISK SCENARIO

SECTION 7.1    Sole Development    12 SECTION 7.2    Commercialization of
Resulting Products    12 SECTION 7.3    [*]    12 SECTION 7.4    Election to
Participate in Development    12 SECTION 7.5    Period of Exclusivity    13
SECTION 7.6    Safety and Other Problems    13

ARTICLE 8

ADVERSE EVENT REPORTING

SECTION 8.1    Adverse Event Reporting    13 SECTION 8.2    Reporting Procedure
   14

ARTICLE 9

TERM; TERMINATION

SECTION 9.1    Term; Termination    14 SECTION 9.2    Consequences of
Termination    15

ARTICLE 10

CONFIDENTIALITY

      16

 

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ARTICLE 11

MISCELLANEOUS

SECTION 11.1    Notices    16 SECTION 11.2    Governing Law    18 SECTION 11.3
   Dispute Resolution    19 SECTION 11.4    Specific Performance    19 SECTION
11.5    No Third Party Beneficiaries    19 SECTION 11.6    Assignment    19
SECTION 11.7    Severability    20 SECTION 11.8    Waivers and Amendments    20
SECTION 11.9    Headings    20 SECTION 11.10    Entire Agreement    20 SECTION
11.11    No Partnership or Joint Venture    20 SECTION 11.12    Governing
Language    20 SECTION 11.13    Counterparts    21

SCHEDULES

 

SCHEDULE 1A    TERRITORY A SCHEDULE 1B    TERRITORY B

EXHIBITS

 

EXHIBIT 6.1-A    RECOMMENDED PRODUCT PROFILES, CLAIM STRUCTURES AND DOSAGES FOR
FILE SUBMISSIONS EXHIBIT 6.1-B    CORE POSITIONING STRATEGIES / KEY MESSAGES
EXHIBIT 6.1-C    CENTRALLY FUNDED PROGRAMS AND EXPENSES EXHIBIT 6.1-D    OVERALL
PRICING GUIDELINES EXHIBIT 6.1-E    PHASES IIIB STUDIES, DIFFERENTIATION
PROGRAMS AND STUDIES FOR NEW INDICATIONS AND LINE EXTENSIONS

 

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This PRODUCT KNOW-HOW LICENSE AGREEMENT (this “Agreement”) dated as of
January 1,1997 is hereby made by and among:

Sanofi, a société anonyme organized and existing under the laws of the French
Republic (“Sanofi”):

Bristol-Myers Squibb Company, a corporation organized and existing under the
laws of the State of Delaware, United States of America (“BMS”); and

Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership, a Delaware
partnership (the “Partnership” and, together with Sanofi and BMS, the “Parties”
and, individually, each a “Party”).

W I T N E S S E T H:

WHEREAS, Sanofi has discovered and patented two new chemical entities, one known
as SR 47436 with the international non-proprietary name Irbesartan
(“Irbesartan”) and one known as SR 25990C with the international non-proprietary
name Clopidogrel Hydrogenosulphate (“Clopidogrel”), with potential ethical
pharmaceutical applications in the cardiovascular therapeutic field;

WHEREAS, Sanofi, BMS and Sterling Winthrop Inc., a Delaware corporation
(“Sterling”) entered into a Development Agreement dated July 29, 1993 (the
“Development Agreement”) for, among other things, the development of Irbesartan
and Clopidogrel;

WHEREAS, pursuant to an Amended and Restated Asset Purchase Agreement dated as
of September 30,1994 among Eastman Kodak Company, Sanofi and Sterling, Sanofi
acquired certain assets, and assumed certain obligations, of the ethical
pharmaceutical business of Sterling, including the rights and obligations of
Sterling under the Development Agreement;

WHEREAS, Sanofi and BMS have entered into a Territory B Alliance Support
Agreement dated as of the date hereof (the “Alliance Support Agreement”) and
have formed through their indirect wholly owned subsidiaries the Partnership
pursuant to the partnership agreement dated as of the date hereof (the
“Partnership Agreement”) for, among other things, the commercialization of the
Products in Territory B (as such terms are defined herein);

WHEREAS, Sanofi and the Partnership have entered into an Irbesartan Intellectual
Property License Agreement (the “Irbesartan License Agreement”) and a
Clopidogrel Intellectual Property License and Supply Agreement dated as of the
date hereof, pursuant to which Sanofi has granted a license to use certain
patents, trademarks and know-how for the commercialization of the Products in
Territory B that neither were developed with nor are owned by BMS;

 

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WHEREAS, Sanofi and BMS have developed certain know-how under the Development
Agreement for the commercialization of the Products in Territory B and, as a
result, each has an undivided one-half direct ownership interest in the
Developed Know-How (as such term is defined herein); and

WHEREAS, Sanofi and BMS are willing to grant to the Partnership, and the
Partnership is willing to accept, a license under the Developed Know-How for the
commercialization of the Products in Territory B on the terms and conditions set
forth herein.

NOW, THEREFORE, in consideration of the mutual covenants and the terms and
conditions set forth herein, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

1.1 Defined Terms. As used in this Agreement, the following terms shall have the
following meanings:

“Adverse Event” means any negative symptom experienced at the time of or after
the taking of any Product of which any Party or any of its Affiliates becomes
aware, whether or not considered drug related, including, without limitation,
any side effects, injury, toxicity or sensitivity reaction, or significant
failure of expected pharmacological action, as well as instances of symptomatic
overdose, abuse or withdrawal reactions.

“Affiliate”, when used with reference to any Person, means any other Person
controlling, controlled by, or under common control with, such Person; provided,
however, that, with respect to Sanofi, the definition of Affiliate shall exclude
Elf Aquitaine and any Person not controlled by Sanofi that would be an Affiliate
of Sanofi solely by reason of its being controlled by Elf Aquitaine. For the
purposes of this definition, “control” shall refer to the possession, directly
or indirectly, of the power to direct the management or policies of a Person or
to veto any material decision relating to the management or policies of a
Person, in each case whether through the ownership of voting securities, by
contract or otherwise, the beneficial ownership, directly or indirectly, of
securities (excluding general partnership interests) representing at least 40%
of the voting power of all outstanding voting securities of a Person or (c) the
beneficial ownership of at least 50% of the partnership interests of a general
partnership. The Parties confirm that each Co-Promotion Entity (as defined in
the Alliance Support Agreement) in Territory B shall be considered to be an
Affiliate of BMS.

“Alliance Agreements” has the meaning set forth in the Alliance Support
Agreement.

“Alliance Strategic Committee” has the meaning set forth in the Alliance Support
Agreement.

“Clopidogrel Product” means the product or products having as an active
ingredient Clopidogrel or any salt, ester, metabolite or pro-drug thereof.

 

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“Competing Product” means, with respect to any Product, any other product that
[*], but which is not [*] set forth in Schedule [*] or selected for [*] by [*].

“Developed Know-How” means any and all technical data, information, material and
other know-how that relate to the formulation of the Products, including,
without limitation, any analytical methodology, chemical, toxicological,
pharmacological and clinical data, formulae, procedures, protocols, techniques
and results of experimentation and testing, developed by Sanofi and BMS under
the Development Agreement.

“Finance Committee” has the meaning set forth in the Alliance Support Agreement.

“Functional Committee” means any Alliance Functional Committee (as such term is
defined in the Alliance Support Agreement) or any License Functional Committee.

“Governmental Authority” means any federal, state or local or any foreign or
supranational government, governmental, regulatory or administrative authority,
agency or commission or any court, tribunal or judicial or arbitral body.

“Irbesartan Product” means the product or products having as an active
ingredient Irbesartan or any salt, ester, metabolite or pro-drug thereof.

“Lead” means the right to initiate proposals and implement, or cause the
implementation of, recommendations and decisions.

“Line Extension” means, for each Product and with respect to development
conducted on or after January, 1 1997, any new dosage or new form of
administration of such Product.

“MAAs” means, with respect to each Product, any marketing authorizations,
licenses, approvals, registrations, certificates and exemptions submitted to or
granted by or pending with any Governmental Authority for the purpose of
allowing the manufacture, production, supply, marketing, distribution or sale of
such Product in a particular country.

“Major B Countries” means any country in Territory B representing at least [*]
of aggregate Net Sales of both Products in Territory B, as determined from time
to time by [*].

“Manufacturing and Sourcing Committee” has the meaning set forth in the Alliance
Support Agreement.

“Marketing Entity” has the meaning set forth in the Partnership Agreement.

“Net Sales” means for any given period and with respect to any Product, the
gross amount invoiced in respect thereof by the Marketing Entities to any Person
(excluding any

 

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transfers between any Party and its Affiliates solely for purposes of resale,
promotional use or clinical trials), less (i) quantity and/or cash discounts,
allowances and/or rebates actually allowed or given, (ii) freight, postage and
shipping insurance expenses (if separately identified in such invoice),
(iii) sales taxes directly related to the sale to the extent included in the
gross invoice price (but not including taxes assessed against the income derived
from such sale) and (iv) amounts repaid or credited on account of rejections,
outdating or the return of such Product.

“New Indication” means, for each Product and with respect to development
conducted on or after January 1, 1997, any new therapeutic use or application of
such Product.

“Non-Promotional Countries” means the countries in Territory B where the
utilization of personal promotion by sales personnel is not a significant factor
in obtaining product usage and achieving sales or where selling is by tender or
comparable non-promotional method of sale, as determined from time to time by
the Finance Committee.

“Person” means any individual, partnership, firm, corporation, société anonyme,
société en nom collectif, société en participation, limited liability company,
joint venture, association, trust or other entity or any government or any
agency or political subdivision thereof, as well as any syndicate or group that
would be deemed to be a person under Section 13(d)(3) of the U.S. Securities
Exchange Act of 1934, as amended.

“Product” means a Clopidogrel Product or an Irbesartan Product and “Products”
means both a Clopidogrel Product and an Irbesartan Product.

“Safety Problem” has the meaning set forth in the Alliance Support Agreement.

“Sanofi Pharma” means Sanofi Pharma, a société anonyme organized and existing
under the laws of the French Republic.

“Serious Adverse Event” means any Adverse Event that is life-threatening in that
such Adverse Event places the patient at risk of dying, requires
hospitalization, prolongs existing hospitalization or results in permanent
disability, birth defect, cancer or death.

“Territory” means either Territory A or Territory B and “Territories” means both
Territory A and Territory B.

“Territory A” means the countries and geographic areas described and listed in
Schedule 1A attached hereto.

“Territory B” means the countries and geographic areas described and listed in
Schedule 1 B attached hereto.

“Third Party” means a Person who or which is neither a Party nor an Affiliate of
a Party.

 

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1.2 Additional Defined Terms. The following additional defined terms shall have
the meanings set forth in the sections of this Agreement listed below:

 

Defined Term

   Section Where Defined

Agreement

   Preamble

Alliance Support Agreement

   Recitals  

BMS

   Preamble

Clopidogrel

   Recitals  

Development Agreement

   Recitals  

Development Committee

   6.2          

Development Royalty

   5.1          

Irbesartan

   Recitals  

Irbesartan License Agreement

   Recitals  

License Functional Committees

   6.2          

License Steering Committee

   6.1          

License Strategic Decisions

   6.1          

License Termination Date

   9.2          

Marketing Working Group

   6.2          

Notices

   11.1          

Ongoing Studies

   2.1          

Other Party

   7.1          

Partnership Agreement

   Recitals  

Partnership

   Preamble

Party

   Preamble

Payment Report

   5.2          

Proposing Party

   7.1          

Regulatory Committee

   6.2          

Reporting Party

   8.2          

Sanofi

   Preamble

Sterling

   Recitals  

ARTICLE 2

GRANT OF LICENSE

2.1 License Grant. Subject to the terms and conditions of this Agreement, Sanofi
and BMS each separately grant to the Partnership an exclusive license for the
term hereof in their respective undivided one-half direct ownership interest in
the Developed Know-How, and the Partnership hereby accepts, an exclusive license
for the term hereof under the Developed Know-How (i) to make, have made, sell,
offer for sale and import the Products in Territory B, (ii) subject to Article 7
hereof, to develop Irbesartan Products and Clopidogrel Products for Territory B,
including, without limitation, New Indications and Line Extensions thereof, and
(iii) with the prior approval of the Manufacturing and Sourcing Committee, to
make, have made, and export the Products outside of Territory B; provided,
however, that such exclusivity shall not apply to Sanofi and BMS with respect to
any ongoing studies that are being conducted by Sanofi and BMS under the
Development Agreement (the “Ongoing Studies”).

 

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2.2 No Transfer. The Partnership hereby acknowledges and agrees that this
Agreement does not, and shall not be deemed to, transfer any proprietary
ownership interest whatsoever to the Partnership in or to the Developed
Know-How. Nothing herein shall give the Partnership any right, title or interest
in or to any of the Developed Know-How, except the rights granted pursuant to
this Agreement.

2.3 No Implicit Rights. All of the rights granted hereunder are explicitly
stated herein and nothing in this Agreement shall be construed to grant any
implied rights whatsoever to the Partnership in or to the Developed Know-How.

2.4 Corporate Name Authorization. The Partnership shall be permitted to use both
the Sanofi and BMS corporate names, on a [*] basis for the term hereof, solely
(i) as part of its corporate name and (ii) in connection with any promotional,
advertising or marketing necessary or desirable for the commercialization of the
Products in Territory B in accordance with this Agreement and the Alliance
Support Agreement. The grant of rights pursuant to this Section 2.4 shall
automatically terminate upon the earlier of (i) the expiration or early
termination of this Agreement and (ii) the expiration or early termination of
the Alliance Support Agreement.

2.5 Goodwill. The Partnership hereby acknowledges that all goodwill connected
with the Sanofi and BMS corporate names shall inure to the benefit of Sanofi and
BMS, as the case may be, and the Partnership shall not take any action that may
be detrimental to such goodwill.

2.6 Representations and Warranties. Each of BMS and Sanofi represents and
warrants to the other Parties hereto that: (i) it has, and will at all times
during the term of this Agreement have, the right, power and authority to
license the Developed Know-How and to perform its other obligations hereunder,
(ii) it is not aware of any asserted or unasserted claims or demand of any Third
Party it believes to be enforceable against the Developed Know-How and (iii) to
the best of such Party’s knowledge and belief, the Partnership’s exercise of any
right to the Developed Know-How, as contemplated by this Agreement, will not
infringe any intellectual property right of any Third Party.

2.7 Improvements. Any new or useful invention, process or improvement,
patentable or unpatentable, relating to the formulation of any Product under the
Developed Know-How developed or acquired by the Partnership during the term
hereof, shall be the property of the Partnership which shall have all ownership
rights thereto, subject to Article 7 hereof.

ARTICLE 3

SUB-LICENSE

3.1 General Sub-License. Except as permitted under Section 3.2 hereof, the
Partnership shall not, without the prior written consent of both Sanofi and BMS,
sub-license any of its rights and obligations under this Agreement; provided,
however, that if the representatives of Sanofi and BMS on any Functional
Committee, the Alliance Strategic Committee or the License Steering Committee,
consensually agree to sub-license any of the Partnership’s rights or

 

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obligations hereunder, such agreement shall be deemed to be the consent of
Sanofi and BMS for the purposes of this Section 3.1. No such sub-license shall
relieve the Partnership of its obligations hereunder.

3.2 Sub-License for Alliance Agreements. The Partnership shall sub-license those
of its rights and obligations under this Agreement, to any Affiliate of Sanofi
or BMS that is a party to any Alliance Agreement, solely for the purposes of
permitting such Affiliate to perform its obligations under such Alliance
Agreement.

3.3 Termination of Sub-License. Sanofi and BMS each shall have the right to
require the Partnership to terminate any sub-license of rights hereunder in the
event that the sub-licensee fails to comply in any material respect with, or
takes any action contrary to, the terms of such sub-license or any decision made
by any Functional Committee, the Alliance Strategic Committee or the License
Steering Committee, and such sub-licensee has failed to remedy such
non-compliance within thirty (30) days from its receipt of written notice
thereof from Sanofi, BMS or the Partnership.

ARTICLE 4

PROVISION OF DOCUMENTS

4.1 Initial Exchange. As promptly as practicable following the date hereof, each
of Sanofi and BMS shall make available to the Partnership copies of all relevant
data, studies and materials comprising Developed Know-How in such Party’s
possession that shall be available as of such date.

4.2 Continuing Exchange. During the term of this Agreement, each of Sanofi and
BMS shall make available to the Partnership, from time to time, copies of all
relevant data, studies and materials comprising subsequently developed or
acquired Developed Know-How in such Party’s possession as soon as practicable
after the development or acquisition thereof.

ARTICLE 5

CONSIDERATION

5.1 Development Royalty. In consideration of the rights and licenses granted
hereunder, the Partnership shall pay, or shall cause to be paid, for the term of
this Agreement the following aggregate amounts as a development royalty (each a
“Development Royalty”):

(i) To [*], an amount equal to [*]of Net Sales of Irbesartan Products in
Territory B; and

(ii) To [*], an amount based on Net Sales of Clopidogrel Products in Territory
B, which shall be determined by [*] no later than sixty (60) days after the
first commercial sale of any Clopidogrel Product in Territory B.

 

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5.2 Payment. For the term of this Agreement, the Partnership shall pay or cause
to be paid to each of Sanofi and BMS all amounts due hereunder on a quarterly
basis within sixty (60) days of the end of each calendar quarter. Each such
payment shall be accompanied by an accurate statement of the amount of Net Sales
of the Products, broken down Product-by-Product, during such calendar quarter
and the calculation of all payments to be made to each of Sanofi and BMS for
such calendar quarter (each a “Payment Report”).

5.3 Method of Payment. (a) All payments to be made hereunder shall be made by
wire transfer in immediately available funds, and shall be made in US dollars to
the respective bank accounts of Sanofi and BMS as notified to the Partnership by
the relevant Party, unless the Parties agree to settle such payments through
other means.

(b) Amounts due from the Partnership to BMS or Sanofi in respect of sales based
on a currency other than US dollars shall be converted to US dollars using the
methodology determined for such purpose by the Finance Committee.

5.4 Records. The Partnership shall maintain (i) books, records and accounts
which accurately and fairly reflect, in reasonable detail, the Net Sales of the
Products and (ii) an adequate system of internal accounting controls. All books,
records and accounts referred to in clause (i) above shall be maintained for not
less than three (3) years, or for such longer period if and as required by
applicable law, following the date of the sales constituting the Net Sales and
shall be made available for reasonable review upon request by Sanofi and/or BMS.

5.5 Payment Reports. (a) At the request of Sanofi, the Partnership shall, and
shall if applicable cause its sub-licensees to, permit Sanofi or an independent,
certified public accountant not having any significant relation to either BMS or
Sanofi, as appointed by Sanofi, at reasonable times and upon reasonable notice,
to examine the books and records of the Partnership as may be necessary to
(i) determine, with respect to any calendar quarter ending not more than two
(2) years prior to the related request, the correctness of any Payment Report or
payment made under this Agreement or any Alliance Agreement or (ii) obtain
information as to the amount payable for any such calendar quarter in the case
of failure on the part of the Partnership to report or pay pursuant to this
Agreement or on the part of any party to any Alliance Agreement; provided,
however, that Sanofi shall not have the right to make such audit request more
than once every twelve (12) calendar months. The results of any such audit shall
be promptly made available to BMS, Sanofi and the Partnership.

(b) Sanofi shall bear the full cost and expense of any such audit, unless such
audit discloses that the amount due to Sanofi is more than the amount paid by
[*] of the amount due, in which case BMS shall bear the full cost and expense of
such audit

(c) The determination by an independent, certified public accountant pursuant to
this Section 5.5 as to the amount due and payable by the Partnership shall be
conclusive and binding on the Parties hereto.

5.6 Taxes. All payments due under this Agreement shall be paid in full without
deduction, except for taxes (if any) required to be withheld by applicable law
in Territory B with respect to such payments. In the event the Partnership is
required under

 

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applicable law to withhold any tax to the revenue authorities in any country in
Territory B regarding any payment to Sanofi and/or BMS, the amount of such tax
shall be deducted by the Partnership and paid to the relevant revenue authority,
and the Partnership shall notify the relevant Party thereof and shall promptly
furnish to such Party all copies of any tax certificate or other documentation
evidencing such withholding. In the event that any such tax shall subsequently
be found to be due, payment of such tax shall be the responsibility of Sanofi or
BMS, as the case may be.

ARTICLE 6

LICENSE STEERING COMMITTEE

6.1 License Steering Committee. In order to ensure the proper use of the
Developed Know-How by the Partnership for the commercialization and further
development of the Products, Sanofi and BMS shall be represented by a License
Steering Committee (the “License Steering Committee”), which shall be
responsible for the following decisions (collectively, the “License Strategic
Decisions”):

(i) recommended Product profiles, claim structures and dosages for file
submissions using the form set forth in Exhibit 6.1-A attached hereto;

(ii) the core positioning strategies and key messages with respect to the
commercialization of the Products using the form set forth in Exhibit 6.1-B
attached hereto;

(iii) approval of the centrally funded budget for certain programs and expenses
using the form set forth in Exhibit 6.1-C attached hereto;

(iv) overall pricing guidelines using the form set forth in Exhibit 6.1-D
attached hereto; and

(v) overall strategy and expenses for Phase IIIB studies, differentiation
programs and studies for New Indications and Line Extensions using the form set
forth in Exhibit 6.1-E attached hereto.

6.2 License Functional Committees. Subject to the general oversight and
authority of the License Steering Committee, the following functional committees
(the “License Functional Committees”) are hereby established and shall be
maintained and empowered as hereinafter provided: (i) a marketing working group
(the “Marketing Working Group”), (ii) a development committee (the “Development
Committee”) and (iii) a regulatory committee (the “Regulatory Committee”).

6.3 Marketing Working Group. (a) The Marketing Working Group shall be
responsible for (i) developing and seeking approval for the centrally funded
budget for certain programs and expenses using the form set forth in Exhibit
6.1-C attached hereto, (ii) implementing such centrally funded budget,
(iii) allocating marketing responsibilities among Sanofi, BMS and their
respective Affiliates, under such centrally funded budget, (iv) the modification
or substitution (if any) of the trademarks for the Products set forth in

 

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Schedule 5.07(b) of the Alliance Support Agreement, (v) developing and
coordinating opinion leader support in Territory B, (vi) analyzing the
competitive market and developing centrally funded programs to implement
differentiation strategies in Territory B, (vii) directing centrally funded
market and outcomes research, (viii) directing Product-related public relations
and communications strategies and (ix) monitoring the sales of the Products and
each Product’s market share in Territory B. The Marketing Working Group shall
report and make its recommendations to the License Steering Committee.

(b) The Marketing Working Group also shall be responsible for developing and
ensuring the implementation of the Territory-wide centrally funded marketing
plan for each Product, and for ensuring that such plan is accurately and fully
communicated to the local entities. Within the Marketing Working Group, Sanofi
shall have the Lead for Clopidogrel Products and BMS shall have the Lead for
Irbesartan Products; provided, however, that, notwithstanding the above, all
recommendations and decisions made by the Marketing Working Group shall be
jointly made pursuant to Section 6.6 (b) hereof.

6.4 Development Committee. The Development Committee shall be responsible for
(i) implementing the decisions made by the License Steering Committee,
(ii) establishing the general strategy for New Indications and Line Extensions
and (iii) overseeing the development of New Indications and Line Extensions, if
such development is conducted jointly by Sanofi and BMS or their respective
Affiliates. Within the Development Committee, Sanofi shall have the Lead for
Clopidogrel Products and BMS shall have the Lead for Irbesartan Products;
provided, however, that, notwithstanding the above, all recommendations and
decisions made by the Development Committee shall be jointly made pursuant to
Section 6.6(b) hereof. The Development Committee shall report and make its
recommendations to the License Steering Committee.

6.5 Regulatory Committee. The Regulatory Committee shall be responsible for
(i) implementing the decisions made by the License Steering Committee, (ii) the
optimal regulatory filing strategies for the Products, (iii) developing and
implementing the regulatory plan for the Products, (iv) liaison activities with
regulatory authorities during the development and initial file review through
approval or registration in each country for the Products, (v) regulatory
activities relating to the development, approval and registration of New
Indications and Line Extensions for the Products and (vi) coordinating
activities related to post-approval safety and surveillance of the Products.
Within the Regulatory Committee, Sanofi shall have the Lead for Clopidogrel
Products and BMS shall have the Lead for Irbesartan Products; provided, however,
that, notwithstanding the above, all recommendations and decisions made by the
Regulatory Committee shall be jointly made pursuant to Section 6.6(b) hereof.
The Regulatory Committee shall report and make its recommendations to the
License Steering Committee.

6.6 Committee Composition and Decision Making. (a) The License Steering
Committee shall at all times consist of six (6) representatives, three (3) of
whom shall represent Sanofi and three (3) of whom shall represent BMS. The
representatives of Sanofi shall be the persons serving from time to time as the
(i) President and Executive Director, Sanofi Pharma (ii) Senior Vice President,
Strategy, Sanofi Pharma and (iii) Vice President, Alliance Management, Sanofi
Pharma. The representatives of BMS shall be the persons serving from to time as
the (i) President, Worldwide Medicines Group (ii) Senior Vice President,
Worldwide Franchise Management and (iii) Vice President, Alliance Management. If
any such position has

 

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been modified or eliminated, the Party so affected shall appoint an individual
whose position is substantially similar to the position so modified or
eliminated. The License Steering Committee shall have the sole power, by a
consensus of the representatives of Sanofi and BMS, to make any and all License
Strategic Decisions and to resolve any deadlock or conflict arising among or
within the License Functional Committees that has not been resolved pursuant to
the Alliance Support Agreement.

(b) Each of the Marketing Working Group, the Development Committee and the
Regulatory Committee shall at all times consist of any equal number of
representatives of Sanofi and BMS. All representatives of each License
Functional Committee shall be senior management personnel of Sanofi and BMS,
respectively, or of their respective Affiliates. All recommendations and
decisions made by each License Functional Committee shall be made by a consensus
of the representatives of Sanofi and BMS thereon. Each License Functional
Committee shall be authorized only to make recommendations to the License
Steering Committee unless, and only to the extent that, it shall have received a
specific written delegation of greater authority from the License Steering
Committee pursuant to Section 6.9 hereof; provided, however, that each License
Functional Committee shall have the authority, by a consensus of the
representatives of Sanofi and BMS thereon, to make decisions on issues within
such License Functional Committee’s specified scope of responsibilities as set
forth in Sections 6.3-6.5 hereof, respectively.

6.7 Committee Dispute Resolution. All disputes arising within the License
Steering Committee, within any License Functional Committee or among the License
Functional Committees shall be resolved pursuant to Section 3.06 of the Alliance
Support Agreement; provided, however, that if agreement cannot be reached with
respect to [*] programs and expenses for any fiscal year pursuant to
Section 3.06 of the Alliance Support Agreement, [*] programs and expenses for
the previous fiscal year shall carry over to the next fiscal year, until [*]
programs and expenses for the next fiscal year shall have been approved.

6.8 Cross-Territory Issues. The License Steering Committee or any License
Functional Committee may agree with its counterpart committee in Territory A
that certain studies, programs or plans will benefit the commercialization or
development of the Products in Territory B as well as Territory A. In such case,
such committee shall negotiate in good faith with its counterpart committee in
Territory A to allocate any expenses related to such studies, programs or plans
between the two Territories, with the expectation that, unless otherwise agreed,
such expenses shall be [*].

6.9 Delegation. The License Steering Committee may, by a consensus of the
representatives of Sanofi and BMS thereon, expressly and by written resolution
establish any other functional committee and delegate its powers to such newly
established functional committee and/or to any then existing License Functional
Committee on such terms as it deems appropriate.

 

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ARTICLE 7

NEW INDICATION OR LINE EXTENSION

SOLE RISK SCENARIO

7.1 Sole Development. If either Sanofi or BMS wishes to pursue the development
of any New Indication or Line Extension, such Party (the “Proposing Party”)
shall propose such development to the other Party (the “Other Party”) in the
context of the Development Committee. If the Other Party decides not to pursue
such development, as evidenced by its negative vote in the Development Committee
with respect to such development and irrespective of whether such Party has the
Lead for the Product with respect to which such development is proposed, then
the Development Committee shall submit such proposal to the License Steering
Committee, which shall decide whether the Proposing Party may proceed alone with
such development. If the License Steering Committee agrees to permit such sole
development, the Proposing Party shall be entitled to undertake such development
at its sole cost and expense.

7.2 Commercialization of Resulting Products. If the Proposing Party proceeds
alone with such development pursuant to Section 7.1 hereof, the Proposing Party
and the Other Party shall, and shall cause their respective Affiliates, to grant
the rights for the development of such New Indication or Line Extension, as the
case may be, to the Proposing Party (with the right to sub-license to its
Affiliates with the consent of the Other Party (which such consent shall not be
unreasonably withheld)) solely for the purposes of pursuing such development in
accordance with the terms of this Agreement In the event the Proposing Party
successfully develops such New Indication or Line Extension, the Proposing Party
hereby acknowledges and agrees that (i) pursuant to Section 2.1 hereof, solely
the Partnership shall have the right to commercialize such New Indication or
Line Extension in Territory B and (ii) such commercialization shall be fully
subject to and performed in accordance with the decisions and recommendations of
the Alliance Strategic Committee, the License Steering Committee and the
Functional Committees in accordance with this Agreement and the Alliance Support
Agreement.

7.3 [*]. In the event of such sole development, the Proposing Party shall be
entitled to receive [*] for such development equal to [*], which shall be [*]
payable to such Party pursuant to Article 5 hereof. In the event that the
Finance Committee cannot agree upon a method of [*], including the [*] under
Section [*] hereof, the Proposing Party and the Other Party shall [*]. The [*],
and the fees and expenses of [*] shall be [*].

7.4 Election to Participate in Development. The Other Party may reverse its
election not to pursue such development, by Notice to the Proposing Party, at
any time prior to the registration of such New Indication or Line Extension in
the first country in Territory B in which registration is made, subject to the
reimbursement of [*] of [*] costs incurred by the Proposing Party with respect
to

 

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such New Indication or Line Extension as of the date on which such Notice is
made. In the event of such reimbursement, the Proposing Party and the Other
Party shall thereafter share [*] costs incurred after the date on which such
Notice is made with respect to such development, and the [*] set forth in
Section [*] hereof shall be [*] by [*], from [*] to [*] of Net Sales of such
Product in Territory B attributable to such New Indication or Line Extension;
provided, however, that only the Proposing Party shall be entitled to [*].

7.5 Period of Exclusivity. If the development undertaken by the Proposing Party
results in (i) an additional period of legal and de facto exclusivity for either
Product as a whole or (ii) the issuance of a new patent for such New Indication
or Line Extension developed through such development resulting in legal and de
facto exclusivity for such New Indication or Line Extension, then the Proposing
Party also shall be entitled to [*]for additional development determined by the
Finance Committee, which shall not be less than [*] nor more than [*] of Net
Sales of such Product in Territory B attributable to the New Indication or Line
Extension. [*] shall be payable in accordance with Article 5 hereof (x) after
the date legal or de facto exclusivity of such Product would otherwise have
ended until the date on which the legal or de facto exclusivity obtained as a
result of the sole development terminates (whichever terminates first), in the
case referred to in clause (i) above, and (y) during the life of the relevant
patent, in the case referred to in clause (ii) above. This [*] shall not exceed
[*] of Net Sales of such Product in Territory B, even if the conditions in both
clauses (i) and (ii) above are satisfied, and shall not be reduced even if the
Other Party exercises its right under Section 7.4 hereof to reverse its election
not to participate in such development.

7.6 Safety and Other Problems. Notwithstanding anything to the contrary in this
Article 7 or in Section 7.05(b) of the Alliance Support Agreement, if either
Sanofi or BMS determines that the development of a New Indication or Line
Extension should be suspended for a safety reason that it believes in good faith
justifies such suspension, or reasonably believes that such development would
have a material adverse effect on the overall development of Irbesartan or
Clopidogrel, as the case may be, or the overall commercial viability of the
resulting Product(s), such Party shall have the unilateral right to veto the
development by the other Party of such New Indication or Line Extension.

ARTICLE 8

ADVERSE EVENT REPORTING

8.1 Adverse Event Reporting. BMS, Sanofi and the Partnership shall each ensure
that, in the marketing of the Products in Territory B, it and each of its
respective Affiliates record, investigate, summarize and review all Adverse
Events and Serious Adverse Events. Each Party shall require that its Affiliates,
sub-licensees and distributors adhere to all requirements of local law which
relate to the reporting and investigation of Adverse Events and Serious Adverse
Events, and each Party shall require that its Affiliates, sub-licensees and
distributors keep such Party informed of such experiences.

 

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8.2 Reporting Procedure. In order that each Party may be fully informed of these
experiences each Party shall report:

 

  (i) In the case of Irbesartan Products, to BMS at:

Bristol-Myers Squibb Company

P.O. Box 4000

Route 206 & Province Line Road

Princeton, NJ 08543.

United States of America

Attention: Vice President, Worldwide Safety and Surveillance

Facsimile: [omitted]

 

  (ii) In the case of Clopidogrel Products, to Sanofi at:

Sanofi Pharma

82, avenue Raspail

94255 Gentilly Cedex, France

Attention: [omitted]

Facsimile: [omitted]

all Adverse Events and Serious Adverse Events anywhere in the world; provided,
however, that Serious Adverse Events shall be reported to the relevant Person
within three (3) working days of a Party’ s becoming aware of such an event (a.
“Reporting Party”) and shall be reported by facsimile as provided above. The
Reporting Party shall report all other Adverse Events on a monthly basis. The
Parties shall agree on an Adverse Event reporting form that may be used by the
Reporting Party as a basis for such reports. Each Party shall promptly notify
the relevant Person of any complaint received by it in sufficient detail and in
sufficient time to allow such Person to comply with any and all regulatory
requirements imposed upon it in any country. Each Party shall also advise the
relevant Person of any regulatory developments (e.g., proposed recalls, labeling
and other registrational dossier changes, etc.) affecting such Product in any
country in Territory B. Each Party shall have the right to review and/or request
copies of any and all information and reporting forms generated or received by
the relevant Person with respect to Adverse Events and Serious Adverse Events.
These procedures may be modified from time to time by the Regulatory Committee.

ARTICLE 9

TERM; TERMINATION

9.1 Term; Termination. (a) The term of this Agreement, with respect to each
Product, shall commence on the date hereof and shall expire on the later of
(x) the 15th anniversary of the first commercial sale of such Product and
(y) such date as the last patent relating to such Product effective in any
country in Territory B shall have expired and all other de jure exclusivity
available for such Product shall have ended. Thereafter, the term of this

 

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Agreement may be renewed with respect to such Product for successive three-year
terms, respectively, by the mutual agreement of the Parties no later than 24
months prior to the expiration of the term then in effect.

(b) Notwithstanding the foregoing, this Agreement shall automatically expire
upon the earlier of (i) the termination by both Parties of the commercialization
of both Products throughout Territory B as the result of a Safety Problem
pursuant to Section 7.04(iii) of the Alliance Support Agreement and (ii) the
exercise by BMS of the special put option pursuant to Section 7.08 of the
Alliance Support Agreement.

(c) The Parties may cause the early termination of this Agreement by the mutual
written consent of each of the Parties,

(d) Either Sanofi or BMS shall have the right to declare termination of this
Agreement upon Notice to the other Parties, following the first to occur of:

(i) such other Party shall have (A) voluntarily commenced any proceeding or
filed any petition seeking relief under Title 11 of the United States Code,
French Law No. 84-148 of March 1, 1984, French Law No. 85-98 of January 25, 1985
or any other bankruptcy, insolvency or similar law of the United States, any
state thereof, the French Republic or any other applicable jurisdiction,
(B) applied for or consented to the appointment of a receiver, trustee,
custodian, sequestrator, conciliator, administrator or similar official for it
or for all or substantially all of its property, (C) filed an answer admitting
the material allegations of a petition filed against or in respect of it in any
such proceeding, (D) made a general assignment for the benefit of creditors of
all or substantially all of its assets, (E) become unable generally, or admitted
in writing its inability to, pay all or substantially all of its debts as they
become due or (F) taken corporate action for the purpose of effecting any of the
foregoing; or

(ii) an involuntary proceeding shall have been commenced or any involuntary
petition shall have been filed in a court of competent jurisdiction seeking
(A) relief in respect of such other Party, or of its property, under Title 11 of
the United States Code, French Law No. 84-148 of March 1, 1984, French Law
No. 85-98 of January 25, 1985 or any other bankruptcy, insolvency or similar law
of the United States, any state thereof, the French Republic or any other
applicable jurisdiction, (B) the appointment of a receiver, trustee, custodian,
sequestrator, conciliator, administrator or similar official for such other
Party or for all or substantially all of its property or (C) the winding-up or
liquidation of such other Party; and such proceeding or petition shall have
continued undismissed for sixty (60) days or an order or decree approving or
ordering any of the foregoing shall have continued unstayed and in effect for
thirty (30) days.

9.2 Consequences of Termination. (a) Upon the expiration or early termination of
this Agreement pursuant to Section 9.1 hereof (the “License Termination Date”):

(i) the terms and conditions of Section 7.07 of the Alliance Support Agreement
shall apply, except in the event of early termination pursuant to Section 9.1(b)
hereof;

 

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(ii) the Partnership shall cease, and shall cause each sub-licensee (if any) to
cease, all activities related to the Developed Know-How; and

(iii) the Partnership shall pay in full all amounts due to Sanofi and/or BMS
hereunder within ten (10) days after the final determination of Net Sales for
such period, including the License Termination Date, pursuant to Sections 5.2,
5.3 and 5.5 hereof which shall survive until the full payment of all amounts
under this clause (iii).

(b) In the event of the termination of the commercialization of any Product
hroughout Territory B pursuant to Section 7.04 of the Alliance Support Agreement
(other than a bilateral termination of such Product as the result of a Safety
Problem), the provisions of Section 9.2(a)(ii)-(iii) hereof shall apply, mutatis
mutandis, with respect to such Product.

(c) In the event of the termination of the commercialization of any Product in
any country(ies) of Territory B pursuant to Section 7.02 of the Alliance Support
Agreement:

(i) the terms and conditions of Section 9.2(a)(ii)-(iii) hereof shall apply,
mutatis mutandis, with respect to such Product in such country(ies); and

(ii) all rights and licenses granted by Sanofi and BMS hereunder with respect to
such Product in such country(ies) shall revert to Sanofi and BMS, respectively,
subject to Section 7.03 of the Alliance Support Agreement.

(d) Expiration or early termination of this Agreement pursuant to this Article
shall be without prejudice to any rights which shall have accrued to the benefit
of any Party prior to Such expiration or termination such expiration or
termination shall not relieve any Party from its obligations which are expressly
indicated to survive the expiration or termination f this Agreement All of the
Parties’ rights and obligations under this subclause (d) and under Sections 5.4,
5.6, 8.1, 8.2, 9.2 and 11.2 -11.4 and Article 10 hereof shall survive such
expiration or termination for the applicable period.

ARTICLE 10

CONFIDENTIALITY

All of the data, material and information exchanged by the Parties hereunder or
related hereto (including, without limitation, the Developed Know-How) shall be
subject to the confidentiality provisions of the Alliance Support Agreement as
set forth in Section 5.03 thereof.

ARTICLE 11

MISCELLANEOUS

11.1 Notices. All notices, requests or other communications hereunder
(collectively, “Notices”) shall be in writing, shall be in the English language,
and shall be given or made by delivery in person, by courier service, by
facsimile (with receipt confirmed) or by registered or certified mail (return
receipt requested, with postage prepaid) to the respective Parties at the
following addresses:

 

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If to Sanofi, to:

 

Sanofi 32-34, rue Marbeuf 75008 Paris, France Attention:    Directeur Juridique
Facsimile:    [omitted] Attention:    Directeur Juridique Adjoint Facsimile:   
[omitted] Attention:    Vice President, Alliance Management Facsimile:   
[omitted]

with a copy to:

 

Cleary, Gottlieb, Steen & Hamilton 41, avenue de Friedland 75008 Paris, France
Attention:    [omitted] Facsimile:    [omitted]

If to BMS, to:

 

Bristol-Myers Squibb Company

P.O. Box 4000

Route 206 & Province Line Road

Princeton, NJ 08543-4000 USA

Attention:   

Vice President and Senior Counsel, Pharmaceutical

Research Institute, and Worldwide Franchise Management

and Business Development

Facsimile:    [omitted] Attention.:    Vice President, Alliance Management
Facsimile:    [omitted]

with a copy to:

 

Shearman & Sterling

599 Lexington Avenue

New York, NY 10022 USA

Attention:    [omitted] Facsimile:    [omitted]

 

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If to the Partnership, to:

 

Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership P.O. Box 4000
Route 206 & Province Line Road Princeton, NJ 08543-4000, USA Attention:    Vice
President and Senior Counsel, Pharmaceutical    Research Institute, and
Worldwide Franchise Management, Business Development Facsimile:    [omitted]
Attention:    Vice President, Alliance Management Facsimile:    [omitted] with a
copy to each of: Sanofi Pharmaceuticals, Inc. 90 Park Avenue    New York, NY
10016, USA Attention:    Senior Vice President and General Counsel Facsimile:   
[omitted] Attention:    Vice President, Alliance Management Facsimile:   
[omitted] and:    Sanofi    32-34, rue Marbeuf 75008 Paris, France Attention:   
Directeur Juridique Facsimile:    [omitted] Attention:    Directeur Juridique
Adjoint Facsimile:    [omitted] Attention:    Vice President, Alliance
Management Facsimile:    [omitted]

or to such other address or facsimile number as hereafter shall be furnished as
provided in this Section 11.1 by any Party hereto to the other Parties hereto.
All Notices given to any Party in accordance with this Section 11.1 shall be
deemed to have been given on the date of receipt if delivered by hand or
overnight courier service or sent by facsimile, or on the date ten (10) business
days after dispatch by certified or registered mail (postage prepaid) if mailed.

11.2 Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York, United States of America,
without regard to the choice of law principles that might otherwise be applied
in such jurisdiction.

 

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11.3 Dispute Resolution. All disputes between the Parties arising in connection
with this Agreement (other than those specifically referred to in Sections 5.5,
6.7 or 7.3 hereof) shall be finally settled under the Rules of Conciliation and
Arbitration of the International Chamber of Commerce, and the number of
arbitrators shall be three. Each of BMS (acting on its own behalf and on behalf
of the Partnership) and Sanofi shall designate one arbitrator and the two so
appointed arbitrators shall jointly designate the third arbitrator. If such
designation is not made within fifteen days of the designation of the second
party designated arbitrator, the Secretary General of the International Court of
Arbitration of the International Chamber of Commerce shall designate the third
arbitrator. The proceedings shall be conducted in the English language in Paris,
France. The president of any arbitral tribunal shall not be a citizen of either
the United States of America or the French Republic.

11.4 Specific Performance. Each Party agrees that the Developed Know-How is
unique, and that a failure by any Party to perform its obligations under this
Agreement will result in irreparable damage, and that specific performance of
such obligations may be obtained without the posting of any bond or other
security; provided however, that the powers of the arbitrators under this
Section 11.4 shall be limited to enforcing the obligations provided for in this
Agreement as drafted.

11.5 No Third Party Beneficiaries. This Agreement shall be binding upon and
inure solely to the benefit of the Parties (including the partners of the
Partnership, each in its capacity as partner thereof) and permitted
sub-licensees and assigns, and nothing herein, express or implied, is intended
to, or shall confer upon, any other Person any legal or equitable right, benefit
or remedy of any nature whatsoever.

11.6 Assignment (a) This Agreement may be assigned by a Party only to an
Affiliate of Sanofi or BMS in the event of a corporate reorganization (including
an entity that becomes an Affiliate in connection with such reorganization)
involving the assumption of all or substantially all of such Party’s marketing
or manufacturing functions in Territory B by such Affiliate, in which event the
rights may be assigned and the obligations may be delegated to such Affiliate.

(b) Notwithstanding anything to the contrary contained in subclause (a) above,
this Agreement may be assigned, in whole or in part, by, or on behalf of, the
Partnership as a result of a termination event under either Section 7.04 or
Section 7.06 of the Alliance Support Agreement or as a result of the dissolution
of the Partnership (other than for a Safety Problem) and in any such event shall
be deemed to be amended and restated (i) to delete Sections 2.4, 2.5, 3.2 and
6.1-6.9 and Articles 7 and 10 hereof, as well as any reference to the Alliance
Support Agreement and (ii) to insert those terms and conditions that are then
customary in the pharmaceutical industry for an intellectual property license
agreement, including, without limitation, provisions for confidentiality,
indemnification and termination for material breach, as well as a diligence
requirement that the assignee shall use reasonable commercial efforts to
actively promote the Product(s) assigned (and the remedy for breach of such
diligence requirement shall be termination of such amended and restated
agreement).

 

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11.7 Severability. If any term or other provision hereof is held to be invalid,
illegal or incapable of being enforced by applicable law or public policy, all
other terms and provisions hereof shall nevertheless remain in full force and
effect so long as the economic effect or legal substance of the transactions
contemplated hereby is not affected in any manner materially adverse to any
Party. Upon such determination that any term or other provision is invalid,
illegal or incapable of being enforced, the Parties shall negotiate in good
faith to modify . This Agreement so as to effect the original intent of the
Parties as closely as possible in an acceptable manner in order that the
transactions contemplated hereby are consummated as originally contemplated to
the greatest extent possible.

11.8 Waivers and Amendments. No modification of or amendment to this Agreement
shall be valid unless in a writing signed by the Parties referring specifically
to this Agreement and stating the Parties’ intention to modify or amend the
same. Any waiver of any term or condition of this Agreement shall be in a
writing signed by the Party sought to be charged with such waiver referring
specifically to the term or condition to be waived, and no such waiver shall be
deemed to constitute the waiver of any other breach of the same or of any other
provision hereof.

11.9 Headings. All titles and captions contained in this Agreement are for the
convenience of reference only and shall not affect in any way the meaning or
interpretation hereof.

11.10 Entire Agreement. This Agreement and the Alliance Support Agreement
constitute the entire agreement of the Parties with respect to the subject
matter contained herein and all prior agreements relative thereto which are not
contained herein are hereby terminated.

11.11 No Partnership or Joint Venture. This Agreement is not intended to create,
and nothing contained herein shall be construed to create an association, joint
venture, trust or partnership, or to impose a trust or partnership covenant,
obligation or liability on or with regard to the other Party. Each Party shall
be severally responsible for its own covenants, obligations and liabilities as
herein provided. Other than the Partnership: (i) no Party shall be under the
control of, or shall be deemed to control any other Party; (ii) no Party is the
legal representative, agent, joint venturer or employee of the other Party with
respect to this Agreement for any purpose whatsoever, and no Party shall have
the right or power to bind the other Party; and (iii) no Party has the right or
authority to assume or create any obligations of any kind or to make any
representation or warranty on behalf of any other Party, whether express or
implied, or to bind any other Party in any respect whatsoever. The provisions of
this Agreement are intended only for the regulation of relations between the
Parties. This Agreement is not intended for the benefit of non-Party creditors,
and no rights are granted to non-Party creditors under this Agreement.

11.12 Governing Language. The Parties acknowledge that this Agreement may be
translated into the French language. The Parties agree that this English
language version shall in all respects be the controlling version of this
Agreement.

 

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11.13 Counterparts. This Agreement may be executed in one or more counterparts,
each of which when executed shall be deemed to be an original, but all of which
when taken together shall constitute one and the same agreement.

IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of the day
and year first written above.

 

SANOFI     BRISTOL-MYERS SQUIBB SANOFI PHARMACEUTICALS HOLDING PARTNERSHIP By:  
/s/ [signature illegible]         Name:         Title:     Represented by:
BRISTOL-MYERS SQUIBB COMPANY    

BRISTOL-MYERS SQUIBB COMPANY INVESTCO INC.,

as General Partner

By:   /s/ [signature illegible]     BY:   /s/ [signature illegible]   Name:    
Name:   Title:     Title:     Witnessed by:    

SANOFI PHARMACEUTICALS, INC.,

a Partner

    By:   /s/ [signature illegible]       Name:       Title:

 

 

171025

 

 

 

 

 

 

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SCHEDULE 1A

TERRITORY A1

Europe:    the United Kingdom Albania   

(including England, Wales,

Andorra   

Scotland, Isle of Man, Alderney,

Austria   

Northern Ireland, Channel Islands)

Belgium    Former USSR (Europe) Bulgaria   

Russia

Cyprus   

Ukraine

The Czech Republic   

Belorus

Slovakia   

Moldavia

Denmark   

Estonia

Finland   

Latvia

France (including Martinique, Guadeloupe, French Guyana,   

Lithuania

French Polynesia, New Caledonia, Reunion and

   Vatican City State

the other Overseas Departments and Territories)

   Former Yugoslavia Germany   

(including Bosnia-Herzegovina,

Gibraltar   

Croatia, Macedonia, Montenegro,

Greece   

Serbia and Slovenia)

Greenland   

Africa:

 

Algeria

Angola

Benin

Botswana

Burkina Faso

Burundi

Cameroon

Hungary    Iceland    Irish Republic    Italy    Liechtenstein    Luxembourg   
Malta and Gozo    Monaco    Cape Verde Islands Netherlands    Central African
Republic Norway    Chad Poland    Comoros Portugal    Congo Romania    Djibouti
San Marino    Egypt Spain    Equatorial Guinea Sweden    Eritrea Switzerland   
Ethiopia    Gabon    Gambia

 

1

Territory A will be deemed to include any new country created by the division,
consolidation or name change of the countries listed below.

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

--------------------------------------------------------------------------------

IA-2

 

Africa (continued):

 

   Asia Ghana    Afghanistan Guinea    Bahrain Guinea-Bissau    Bangladesh Ivory
Coast    Bhutan Kenya    Brunei Lesotho    Cambodia Liberia    China (including
Tibet) Libya   

Taiwan

Madagascar   

Macao

Malawi    Hong Kong Mali    India Mauritania    Indonesia Mayotte    Israel
Mauritius, etc,    Jordan Morocco    South Korea Mozambique    Kuwait Namibia   
Laos Niger    Lebanon Nigeria    Malaysia Occidental Sahara    Maldive Rwanda   
Islands St Helena    Mongolia

Ascension

   Myanmar

Tristan de Cunha

   Nepal Sao Tome & Principe    Oman Senegal    Pakistan Seychelles   
Philippines Siena Leone    Qatar Somalia    Saudi Arabia South Africa   
Singapore Spanish Presidios:    Sri Lanka

Ceuta

   Syria

Melilla

   Thailand Sudan    Turkey Swaziland    United Arab Emirates Tanzania    Former
USSR (Asia) Togo   

RSFSR (Asia)

Tunisia   

Armenia (Hyastan)

Uganda   

Azerbaidjan

Zaire   

Turkmenistan

Zambia   

Uzbekistan

Zimbabwe   

Tadjikistan

  

Kazakhstan

  

Kirghizia

   Vietnam    Yemen

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

--------------------------------------------------------------------------------

 

SCHEDULE 1B

TERRITORY B2

 

North America:    Oceania: Canada    Australia Mexico    Fiji United States of
America    Micronesia

(including Puerto Rico, US Virgin

  

(including Caroline, Kiribati,

Islands, Guam, American Samoa) for

  

Mariana and Marshall Islands)

Clopidogrel only

 

Central America and the West Indies:

 

Anguilla

Antigua

Aruba

Bahamas

Barbados

Belize

Bermuda

Cayman Islands

Costa Rica

Dominica

Dominican Republic

Grenada

Guatemala

Haiti

Honduras

Jamaica

Montserrat

  

Nauru

New Zealand

Papua New Guinea

Pitcairn Islands

Samoa (non-US)

Solomon Islands

Tonga

Tuvalu

Vanuatu

 

South America:

 

Argentina

Bolivia

Brazil

Chile

Colombia

Ecuador

Falkland Islands

Guyana

Paraguay

                                                      Netherlands Antilles   
Peru Nicaragua    Surinam Panama    Uruguay St. Kitts-Nevis    Venezuela St.
Lucia    St. Vincent and the Grenadines    El Salvador    Trinidad and Tobago   
Turks and Caicos Islands    Virgin Islands (British)   

 

2 Territory B will be deemed to include any country created by the division,
consolidation or name change of the countries listed below.

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

--------------------------------------------------------------------------------

 

EXHIBIT 6.1-A

RECOMMENDED PRODUCT PROFILES. CLAIM STRUCTURES

AND DOSAGES

FOR FILE SUBMISSIONS

Description: Recommended indications, major claims and dosage

PRODUCT:                     

Product Profile:

Indications:

Major Claims:

Dosage:

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

--------------------------------------------------------------------------------

 

EXHIBIT 6.1-B

CORE POSITIONING STRATEGIES / KEY MESSAGES3

Description: Outline of core position and key messages

PRODUCT:                     

Core Positioning Strategy:

Key Messages:

 

 

3 Promotional messages may be developed in each country to address local needs
and conditions so long as they are consistent with the core positioning
strategies and key messages.

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

--------------------------------------------------------------------------------

 

EXHIBIT 6.1-C

CENTRALLY FUNDED PROGRAMS AND EXPENSES

PRODUCT:                     

 

     1996
Projection    1997 Budget    1997
Total    1998
Estimate

U.S.$ 000

      1st Q    2nd Q    3rd Q    4th Q      

Meetings / Symposia / Roundtables

                    

Advertising

                    

Advisory Boards/Consultants

                    

Agency Fees

                    

Regulatory Fees

                    

Phase IIIB/IV (1)

                    

Phase V Trials (1)

                    

Total

                    

 

(1) Includes all costs: tablets, investigators, etc.

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

--------------------------------------------------------------------------------

 

EXHIBIT 6.1-D

OVERALL PRICING GUIDELINES

Description: Range and rationale for recommended pricing guidelines

PRODUCT:                     

Overall pricing guidelines:

Rationale:

Comparative competitive products:

Market conditions:

Product differentiation:

Other:

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

--------------------------------------------------------------------------------

 

EXHIBIT 6.1-E

PHASE IIIB STUDIES, DIFFERENTIATION PROGRAMS

AND STUDIES FOR NEW INDICATIONS AND LINE EXTENSIONS

Description:

PRODUCT:                     

Priority Studies

 

Study

 

Objective

 

Start
Date

 

Completion Date

 

Total Cost

                               

 

* CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED

SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION