Exhibit 10w

*Confidential Treatment Requested

 

 

 

AMENDED AND RESTATED

CLOPIDOGREL

INTELLECTUAL PROPERTY LICENSE

AGREEMENT

between

SANOFI

and

BRISTOL-MYERS SQUIBB SANOFI PHARMACEUTICALS HOLDING PARTNERSHIP

dated as of January 1, 2013

 

 

 

 

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TABLE OF CONTENTS

 

ARTICLE 1    DEFINITIONS   

1.1

   Defined Terms      2   

1.2

   Additional Defined Terms      5    ARTICLE 2    GRANT OF LICENSE   

2.1

   License Grant      6   

2.2

   No Transfer      6   

2.3

   No Implicit Rights      7   

2.4

   Goodwill      7   

2.5

   Improvements      7   

2.6

   Original License      7    ARTICLE 3    SUB-LICENSE   

3.1

   General Sub-License      7   

3.2

   Sub-License for Alliance Agreements      7   

3.3

   Termination of Sub-License      7    ARTICLE 4   CONSIDERATION  

4.1

   Discoverer’s Remuneration      8   

4.2

   Payment      8   

4.3

   Method of Payment      8   

4.4

   Records      8   

4.5

   Payment Reports      8   

4.6

   Taxes      9    ARTICLE 5    TRADEMARKS; PATENTS; INFRINGEMENT   

5.1

   Maintenance      9   

5.2

   Registration      9   

5.3

   Undertaking of the Partnership      9   

5.4

   Compliance      9   

5.5

   Quality Standards      10   

5.6

   Quality Control      10   

5.7

   Failure to Meet Standards      10   

5.8

   Patent and Trademark Infringement      10   

5.9

   Notification of Infringement      11   

5.10

   Invalidity or Nullity      11   

5.11

   [*]      12   

 

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ARTICLE 6    TERM; TERMINATION   

6.1

   Term; Termination      12   

6.2

   Consequences of Termination      13    ARTICLE 7    CONFIDENTIALITY   
ARTICLE 8    MISCELLANEOUS   

8.1

   Notices      14   

8.2

   Governing Law      15   

8.3

   Dispute Resolution      15   

8.4

   Specific Performance      16   

8.5

   No Third Party Beneficiaries      16   

8.6

   Assignment      17   

8.7

   Severability      17   

8.8

   Waivers and Amendments      17   

8.9

   Headings      17   

8.10

   Entire Agreement      17   

8.11

   No Partnership or Joint Venture      18   

8.12

   Governing Language      18   

8.13

   Force Majeure      18   

8.14

   Counterparts      18   

SCHEDULES

 

SCHEDULE 1A    LICENSED PATENTS SCHEDULE 1B    LICENSED TRADEMARKS

 

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This AMENDED AND RESTATED CLOPIDOGREL INTELLECTUAL PROPERTY LICENSE (this
“Agreement”) dated as of January 1, 2013 is hereby made by and between:

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

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

W I T N E S S E T H:

WHEREAS, Licensor previously discovered and patented a new chemical entity known
as SR 25990C with the international non-proprietary name Clopidogrel
Hydrogenosulphate (“Clopidogrel”);

WHEREAS, Licensor, Bristol-Myers Squibb Company, a Delaware corporation (“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 Clopidogrel;

WHEREAS, pursuant to an Amended and Restated Asset Purchase Agreement dated as
of September 30, 1994 among Eastman Kodak Company, Licensor and Sterling,
Licensor 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, Licensor and BMS have entered into a Territory B Alliance Support
Agreement dated as of January 1, 1997, as amended 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 January 1, 1997, as amended as of the date hereof (the “Partnership
Agreement”) for, among other things, the commercialization of Clopidogrel
Products in certain territories, including Territory B (as such terms are
defined herein);

WHEREAS, Licensor, BMS and the Partnership have entered into a Product Know-How
License Agreement for Territory B dated as of January 1, 1997, as amended as of
the date hereof (the “Know-How License Agreement”), pursuant to which Licensor
and BMS have granted to the Partnership a license to use certain know-how for
the commercialization of Clopidogrel Products and which was developed by
Licensor and BMS under the Development Agreement;

WHEREAS, Licensor owns or has acquired independent of BMS certain intellectual
property, including certain patents, trademarks and know-how, for the
commercialization of Clopidogrel Products in certain territories, including
Territory B;

 

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WHEREAS, Licensor and the Partnership have entered into a Clopidogrel
Intellectual Property License and Supply Agreement, dated as of January 1, 1997,
as amended by the Amendment to the Clopidogrel Intellectual Property License and
Supply Agreement, dated December 6, 2007 (as amended, the “Original License”),
pursuant to which Licensor granted to the Partnership a license under certain
intellectual property, including certain patents, trademarks and know-how, for
the commercialization of Clopidogrel Products in certain territories, including
Territory B;

WHEREAS, the Partnership has been commercializing Clopidogrel Products in
Territory B since that date;

WHEREAS, Licensor and its Affiliates have the exclusive right, subject to the
terms and conditions set forth in this Agreement, to provide the active
substance chemical bulk containing Clopidogrel (the “Clopidogrel Bulk”) that is
required for the development, clinical testing and manufacturing of Clopidogrel
Products in Territory B;

WHEREAS, pursuant to the Master Restructuring Agreement (the “Definitive
Agreement”), dated as of September 27, 2012, by and between Licensor and BMS,
Licensor and BMS have agreed to simplify the overall governance, operating and
financial principles of their alliance with respect to Clopidogrel Products,
other than in the United States and Puerto Rico; and

WHEREAS, in connection with the transactions contemplated by the Definitive
Agreement, Licensor and BMS have agreed to, among other things, amend and
restate the Original License on the terms 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:

“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
L’Oréal, a société anonyme organized and existing under the laws of the French
Republic. For the purposes of this definition, “control” shall refer to (a) 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; (b) the beneficial ownership, directly or
indirectly, of securities (excluding general partnership interests) representing
at least 50% 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.

 

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“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.

“BMS Partner” means Bristol-Myers Squibb Investco, L.L.C., a partner in the
Partnership.

“Clopidogrel Intellectual Property” means the Clopidogrel Know-How and the
Licensed Patents.

“Clopidogrel Know-How” means any and all technical data, information, material
and other know-how that relate to the manufacturing and purification of the
Clopidogrel Bulk, including, without limitation, any analytical methodology,
chemical, procedures, protocols, techniques and results of experimentation and
testing, solely owned, developed or acquired by Licensor and its Affiliates as
of the date hereof.

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

“fixed dose combination” means a pharmaceutical dosage form containing fixed
doses of more than one active ingredient in which all active ingredients are
present in a single tablet, capsule or other form and shall expressly exclude
so-called “co-packaging” in which separate drugs in separate dosage forms are
sold in a single unit or bundle.

“Fixed Dose Combination Product” means a fixed dose combination containing
Clopidogrel.

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

“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.

“License Steering Committee” has the meaning set forth in the Know-How License
Agreement.

“Licensed Intellectual Property” means the Clopidogrel Intellectual Property and
the Product Intellectual Property.

“Licensed Patents” means the patents and patent applications of Licensor and its
Affiliates existing on the date hereof that relate to Clopidogrel and
Clopidogrel Products, as listed on Schedule 1A attached hereto and all reissues,
renewals, divisions, continuations, continuations-in-part, reexaminations,
patent term restorations, patents of additions and extensions thereof.

 

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“Licensed Trademarks” means the trademarks and registered trademarks and
applications for registered trademarks in Territory B listed on Schedule 1B
attached hereto, and any trademarks, registered trademarks and applications for
registered trademarks that are confusingly similar to or replacements for the
foregoing and that are selected by Licensor for use in connection with
Clopidogrel Product.

“Line Extension” has the meaning set forth in the Know-How License Agreement.

“MAA” means 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 any Clopidogrel Product in a
particular country.

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

“Net Sales” means for any given period and with respect to any Clopidogrel
Product, the gross amount invoiced in respect thereof by the Marketing Entities
to any Person (excluding any 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 Clopidogrel Product,
provided that the [*].

“New Drug Application” means the application required to be filed with the
relevant Governmental Authority in any country in order to obtain approval to
market commercially any Clopidogrel Product in such country.

“New Indication” has the meaning set forth in the Know-How License Agreement.

“New IP Agreement” means the FDC Intellectual Property License Agreement between
Licensor and BMS, dated as of the date hereof.

“Person” means any individual, partnership, firm, corporation, société anonyme,
société en nom collectif, société en participation, société par actions
simplifiée, 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.

 

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“Product Intellectual Property” means the Product Know-How, the Licensed
Trademarks and the Licensed Patents.

“Product Know-How” means any and all technical data, information, material and
other know-how that relate to the formulation of Clopidogrel Products,
including, without limitation, any analytical methodology, chemical,
toxicological, pharmacological and clinical data, formulae, procedures,
protocols, techniques and results of experimentation and testing, solely owned,
developed or acquired by Licensor as of the date hereof.

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

“Sanofi Partner” means sanofi-aventis U.S. LLC, a partner in the Partnership.

“Territory B” or the “United States” means any State or Commonwealth of the
United States of America, the District of Columbia, Puerto Rico, the U.S. Virgin
Islands, Guam, American Samoa and any other territory, possession or military
base of the United States of America.

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

“U.S. Excise Tax” shall mean the “Annual Fee on Branded Prescription
Pharmaceutical Manufacturers” payable by the U.S. Plavix Partnership to the U.S.
government under Section 9008 of the Patient Protection and Affordable Health
Care Act of 2010, as amended by Section 1404 of the Health Care and Education
Reconciliation Act of 2010, enacted into law by the United States Congress on
23 March 2010 and amended on 30 March 2010. H.R. 3590, Pub. L. No. 111-148, 124
Stat. 119 (2010), as amended by H.R. 4872, Pub. L. No. 111-152, 124 Stat. 1029
(2010), as the same may hereafter be modified by any successor legislation
thereto.

“U.S. Plavix Partnership” shall mean Bristol-Myers Squibb/Sanofi Pharmaceuticals
Partnership, the partnership established pursuant to the Partnership Agreement
effective as of October 1, 1997 between E.R. Squibb & Sons, Inc. and
sanofi-aventis U.S. LLC, as amended.

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    Recitals
Clopidogrel    Recitals Clopidogrel Bulk    Recitals Definitive Agreement   
Recitals

 

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Defined Term

  

Section Where Defined

Development Agreement    Recitals Dispute    8.3 Dispute Resolution Notice   
8.3

Force Majeure

ICC

  

8.13

8.3

Know-How License Agreement    Recitals License Termination Date    6.2(a)
Licensor    Preamble Notices    8.1 Original License    Recitals Partnership
Agreement    Recitals Partnership    Preamble Party    Preamble Payment Report
   4.3

Plavix Supply Agreement

Quality Standards

  

2.1

5.5

Sterling    Recitals

ARTICLE 2

GRANT OF LICENSE

2.1 License Grant. Subject to the terms and conditions of this Agreement,
Licensor hereby grants to the Partnership, and the Partnership hereby accepts,
an exclusive license for the term hereof under the Product Intellectual Property
(a) to sell, offer for sale and import Clopidogrel Products in Territory B, and
(b) to develop Clopidogrel Products for Territory B, including, without
limitation, New Indications and Line Extensions thereof; provided that the
foregoing exclusivity granted in paragraphs (a) and (b) shall not apply to
Licensor and BMS to the extent of their respective rights (both granted and
retained) under the New IP Agreement with respect to Fixed Dose Combination
Products.

Subject to the occurrence of a change in exclusivity of supply under Section 4.3
of the Plavix Finished Product Supply Agreement (“Plavix Supply Agreement”)
between sanofi-aventis U.S. LLC, as supplier, and the Partnership, as purchaser,
dated as of the date hereof, Licensor hereby grants to the Partnership, subject
to the terms and conditions of this Agreement, an exclusive license under the
Product Intellectual Property to manufacture and package, or have manufactured
and packaged, the Clopidogrel Products for sale in Territory B, for the term and
to the extent needed to cover the period of exclusivity change.

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 Licensed
Intellectual Property. Nothing herein shall give the Partnership any right,
title or interest in or to any of the Licensed Intellectual Property, except the
rights granted pursuant to this Agreement.

 

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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 Licensed Intellectual
Property.

2.4 Goodwill. The Partnership hereby acknowledges that all goodwill connected
with the Licensed Trademarks shall inure to the benefit of Licensor, and the
Partnership shall not take any action that may be detrimental to such goodwill.

2.5 Improvements. Any new or useful invention, process or improvement,
patentable or unpatentable, relating to the formulation of any Clopidogrel
Product under the Clopidogrel Intellectual Property developed or acquired by the
Partnership during the term hereof shall be the property of the Partnership,
which shall have all ownership rights thereto.

2.6 Original License. The Parties hereby agree that all acts, omissions and
occurrences prior to the date hereof, and all rights and obligations of the
Parties with respect thereto, shall be governed by the terms of the Original
License prior to its amendment and restatement in accordance with the terms
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 Licensor,
sub-license any of its rights and obligations under this Agreement; provided,
however, that if the representatives of Licensor 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 obligations hereunder,
such agreement shall be deemed to be Licensor’s consent 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 Licensor
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. Licensor shall have the right to require the
Partnership to terminate any sub-license 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 Licensor or the
Partnership.

 

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ARTICLE 4

CONSIDERATION

4.1 Discoverer’s Remuneration. In consideration of the rights and licenses
granted hereunder, the Partnership shall pay, or shall cause to be paid,
directly to Licensor for the term hereof a [*] in the amount of [*] of Net Sales
of Clopidogrel Products in Territory B.

4.2 Payment. For the term of this Agreement, the Partnership shall pay or cause
to be paid to Licensor 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 Clopidogrel
Products in Territory B during such calendar quarter and the calculation of all
payments to be made to Licensor for such calendar quarter (each a “Payment
Report”).

4.3 Method of Payment. 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
bank account of Licensor as notified to the Partnership, unless the Parties
agree to settle such payments through other means.

4.4 Records. The Partnership shall maintain (i) books, records and accounts
which accurately and fairly reflect, in reasonable detail, the Net Sales of
Clopidogrel Products in Territory B 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 [*], 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 Licensor.

4.5 Payment Reports. (a) At the request of Licensor, the Partnership shall, and
shall if applicable cause its sub-licensees to, permit Licensor or an
independent, certified public accountant not having any significant relation to
either BMS or Licensor, as appointed by Licensor, 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 [*] 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 Licensor shall not have the right to make such audit request more
than once every [*]. The results of any such audit shall be promptly made
available to BMS, Licensor and the Partnership.

(b) Licensor shall bear the full cost and expense of any such audit, unless such
audit discloses that the amount due to Licensor 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 4.5 as to the amount due and payable by the Partnership shall be
conclusive and binding on the Parties hereto.

 

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4.6 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 applicable law to withhold any tax to the revenue authorities in
any country in Territory B regarding any payment to Licensor, the amount of such
tax shall be deducted by the Partnership and paid to the relevant revenue
authority, and the Partnership shall notify Licensor thereof and shall promptly
furnish to Licensor 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 Licensor.

ARTICLE 5

TRADEMARKS; PATENTS; INFRINGEMENT

5.1 Maintenance. Subject to Article X of the Alliance Support Agreement,
Licensor shall maintain in full force and effect all Licensed Patents and
Licensed Trademarks for the term of this Agreement and shall bear all costs and
expenses related thereto. In the event that Licensor or the Partnership becomes
aware of a registration for or an application to register a trademark which it
believes is reasonably likely to conflict with any Licensed Trademark, it shall
promptly inform the other Party in writing of the same, giving particulars
thereof. Licensor shall have the first right to commence an opposition or
cancellation proceeding against such trademark application or registration. If
Licensor decides not to commence an opposition or cancellation proceeding, it
shall promptly inform the Partnership in writing of the same and the Partnership
shall have the right, but not the obligation to commence an opposition or
cancellation proceeding against the trademark application or registration. The
cost and expenses of any such opposition or cancellation proceeding commenced by
either Licensor or the Partnership shall be borne by the Partnership. Each Party
shall execute all necessary and proper documents and take such actions as shall
be appropriate to assist the other Party in commencing and prosecuting such
opposition or cancellation proceeding.

5.2 Registration. The Licensed Trademarks in Territory B are filed and shall be
maintained in the name of Licensor. The Partnership shall execute and deliver to
Licensor, in such form as Licensor shall reasonably request, any and all
documents which may be necessary or desirable to assist Licensor in renewing the
Licensed Trademarks, or in recording the Partnership as a registered user of the
Licensed Trademarks, if necessary.

5.3 Undertaking of the Partnership. The Partnership agrees not to register or
attempt to register in any country in Territory B any trade name, trademark,
service mark, certification mark or logo that is confusingly similar to, or that
contains elements that are confusingly similar to, any Licensed Trademark.

5.4 Compliance. The Partnership shall comply with all notice and marking
requirements under applicable intellectual property laws and labeling
requirements under applicable law that are necessary or advisable for the
protection and enforcement of the Licensed Trademarks or the Licensed Patents.
The Partnership shall further comply with all applicable laws and regulations
related to the manufacture, marketing, distribution and sale of Clopidogrel
Products in Territory B.

 

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5.5 Quality Standards. Licensor, and where relevant the Partnership pursuant to
a change in exclusivity of supply under the Plavix Supply Agreement, shall make
or have made Clopidogrel Products according to the quality standards established
in accordance with the New Drug Applications and the MAAs (the “Quality
Standards”). All promotional and packaging materials to be used in connection
with Clopidogrel Products shall be submitted to Licensor so that Licensor may
ensure the correct use of the Licensed Trademarks thereon, and the Partnership
shall not use any such promotional or packaging materials without the prior
consent of Licensor (which consent shall not be unreasonably withheld);
provided, however, that such consent shall be deemed to have been given if
Licensor shall not have provided Notice to the Partnership of its objection to
any such promotional or packaging material within fifteen (15) days after its
receipt thereof, and provided, further, that such consent shall be deemed to
have been given with regard to packaging materials as long as Licensor or
Licensor’s Affiliates continue to exclusively pack the Clopidogrel Products
under the Plavix Supply Agreement.

5.6 Quality Control. If, as a result of a change in exclusivity of supply under
the Plavix Supply Agreement, the Partnership uses manufacturers and/or packers
other than Licensor or Licensor’s Affiliates, the Partnership shall carry out
quality control tests that are customary in the pharmaceutical industry to
determine that all Clopidogrel Products and packaging related thereto sold by or
on behalf of the Partnership conform to the Quality Standards. The Partnership
shall keep full and complete testing records, which shall be made available for
reasonable review upon request by Licensor. Upon reasonable request, the
Partnership shall permit Licensor to inspect the manufacturing and/or packing
facilities used by or on behalf of the Partnership and, during such inspection,
Licensor shall have the right to make such tests as it deems necessary to ensure
that the Quality Standards are being maintained.

5.7 Failure to Meet Standards. The Partnership agrees that Clopidogrel Products
not meeting the Quality Standards shall not be labeled or used or offered for
sale under the Licensed Trademarks. Unless otherwise agreed, any products that
are not Clopidogrel Products may not be advertised or otherwise promoted,
directly or indirectly, by the Partnership with any reference to the Licensed
Trademarks, and the Partnership shall instruct its distributors to comply with
this restriction.

5.8 Patent and Trademark Infringement. During the term of this Agreement, if the
Partnership or Licensor becomes aware of the infringement or threatened
infringement of any Licensed Patent or Licensed Trademark, it shall promptly
notify the other Party in writing of the same, giving particulars thereof.
Licensor shall have the first right to institute an action based on such
infringement or threatened infringement and shall be responsible for the conduct
of such action. The Partnership shall assist and cooperate with Licensor to the
extent necessary in the conduct of such action. If Licensor notifies the
Partnership in writing that it does not propose to take action against the
infringer, or if within two (2) months of notification of the infringement or
threatened infringement, Licensor has taken no demonstrable action to enjoin or
address such infringement or threatened infringement against the infringer, the
Partnership shall

 

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have the right, but not the obligation, to institute an infringement action. The
costs and expenses of any such infringement action (including, without
limitation, fees of attorneys and other professionals) shall be borne by the
Partnership. Each Party shall execute all necessary and proper documents and
take such actions as shall be appropriate to allow the other Party to institute
and prosecute such infringement actions and Licensor shall, if required, lend
its name to enable the Partnership to conduct the proceedings. Any award or
other consideration paid by Third Parties as a result of an infringement action
(whether by way of settlement or otherwise) shall be allocated between Licensor
and BMS on the basis of [*] applied to the date as of which the award or other
consideration is received.

5.9 Notification of Infringement. In the event of the institution of any suit by
a Third Party against either Party or any of their respective Affiliates for
patent and/or trademark infringement and/or infringement of any other
intellectual property rights involving Clopidogrel or Clopidogrel Products in
Territory B, such Party shall promptly notify the other Party in writing of such
suit. Licensor shall have the first right to conduct the defense of any such
suit. Licensor shall notify the Partnership within a reasonable amount of time
after notification of the institution of such a suit if it elects not to defend
such suit. If Licensor does not elect to defend such suit, the Partnership shall
have the right, but not the obligation, to conduct the defense of such suit. The
costs and expenses of any such suit (including, without limitation, fees of
attorneys and other professionals) shall be borne by the Partnership. Each Party
hereby agrees to assist and cooperate with the other Party, to the extent
necessary, in the defense of such suit. Any award or other consideration paid by
a Third Party as a result of such suit (whether by way of settlement or
otherwise) shall be allocated between Licensor and BMS on the basis of [*]
applied to the date as of which the award or other consideration is received.

5.10 Invalidity or Nullity. Licensor shall have the first right to conduct the
defense of any suit brought by a Third Party based on the invalidity or nullity
of a Licensed Patent other than an action instituted by way of counterclaim in
an action for infringement of a Licensed Patent, in which case the Party
conducting the infringement action shall have the right to conduct the defense.
The Partnership shall assist and cooperate with Licensor to the extent necessary
in the defense of such suit. If Licensor notifies the Partnership in writing
that it does not propose to conduct the defense of such suit, or if within two
(2) months of notification of such suit, Licensor has taken no demonstrable
action to conduct the defense of such suit, the Partnership shall have the
right, but not the obligation, to conduct the defense of such suit. The costs
and expenses of any such action (including, without limitation, fees of
attorneys and other professionals) shall be borne by the Partnership. Each Party
shall execute all necessary and proper documents and take such actions as shall
be appropriate to allow the other Party to conduct the defense of such suit and
Licensor shall, if required, lend its name to enable the Partnership to conduct
the proceedings. Any award or other consideration paid by a Third Party as a
result of such suit (whether by way of settlement or otherwise) shall be
allocated between Licensor and BMS on the basis of [*] applied to the date as of
which the award or other consideration is received.

 

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5.11 [*] Notwithstanding anything to the contrary contained herein or in the
Alliance Support Agreement, Licensor shall have no obligation to maintain,
prosecute or defend any patent set forth on Schedule 1A hereto under the heading
[*].

ARTICLE 6

TERM; TERMINATION

6.1 Term; Termination. (a) The term of this Agreement shall commence on the date
hereof and shall expire on December [*], 2019. Thereafter, the term of this
Agreement may be renewed for successive three-year terms 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 Clopidogrel 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) This Agreement may be terminated by the mutual written consent of each of
Licensor, the Sanofi Partner and the BMS Partner.

(d) Licensor shall have the right to declare termination of this Agreement upon
Notice to the Partnership, following the first to occur of:

(i) the BMS Partner shall have (A) voluntarily commenced any proceeding or filed
any petition seeking relief under Title 11 of the United States Code, Book VI of
the French Commercial Code (legislative part as well as regulatory part) 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 the BMS Partner, or of its property, under Title 11 of
the United States Code, Book VI of the French Commercial Code (legislative part
as well as regulatory part) 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 the BMS Partner
or for all or substantially all of its property or (C) the winding-up or
liquidation of the BMS Partner; 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.

 

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6.2 Consequences of Termination. (a) Upon the expiration or early termination of
this Agreement pursuant to Section 6.1 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 6.1(b)
hereof;

(ii) the Partnership shall cease, and shall cause each sub-licensee (if any) to
cease, all activities related to the Licensed Intellectual Property; and

(iii) the Partnership shall pay in full all amounts due to Licensor hereunder
within ten (10) days after the final determination of Net Sales for such period,
including the License Termination Date, pursuant to Sections 4.2, 4.3 and 4.5
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 the Clopidogrel
Products in any country of Territory B pursuant to Section 7.02 of the Alliance
Support Agreement:

(i) the terms and conditions of Section 6.2(a)(ii)-(iii) hereof shall apply,
mutatis mutandis, with respect to such country; and

(ii) all rights and licenses granted by Licensor hereunder with respect to such
country shall revert to Licensor, subject to Section 7.03 of the Alliance
Support Agreement.

(c) Expiration or early termination of this Agreement pursuant to this Article 6
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 of this Agreement. All of the
Parties’ rights and obligations under this subclause (c) and under Sections 4.4,
4.5, 4.6, 6.2, 8.2-8.4, Article 7 and, with respect to actions or suits
commenced prior to the date of expiration or early termination hereof and until
each such action or suit is finally resolved, Sections 5.1, 5.8, 5.9 and 5.10
hereof, shall survive such expiration or termination for the applicable period.

ARTICLE 7

CONFIDENTIALITY

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

 

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ARTICLE 8

MISCELLANEOUS

8.1 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:

If to Licensor, to:

Sanofi

54, rue la Boétie

75008 Paris, France

Attention: Senior Vice President, Legal Affairs and General Counsel

Facsimile: (33.1) 53.77.43.03

Attention: Vice President, Alliances & Partnerships

Facsimile: (33.1) 53.77.40.99

with a copy to:

Weil Gotshal & Manges

767 Fifth Avenue

New York NY 10153

Attention: [omitted]

Facsimile: 212 310 8007

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 Associate General Counsel, Transactional Practice
Group

Facsimile: (1 609) 252-7680

with a copy to each of:

sanofi-aventis U.S. LLC

55 Corporate Drive

Bridgewater, NJ 08807 USA

Attention: [omitted]

Facsimile: (908) 981-5705

 

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[omitted].

General Counsel, North America

sanofi-aventis U.S. LLC

55 Corporate Drive

Bridgewater, NJ 08807

Fax: (908) 981-7833

and:

Sanofi

54, rue la Boétie

75008 Paris, France

Attention: Senior Vice President, Legal Affairs and General Counsel

Facsimile: (33.1) 53.77.43.03

Attention: Vice President, Alliances & Partnerships

Facsimile: (33.1) 53.77.40.99

or to such other address or facsimile number as hereafter shall be furnished as
provided in this Section 8.1 by any Party hereto to the other Party hereto. All
Notices given to any Party in accordance with this Section 8.1 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.

8.2 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.

8.3 Dispute Resolution.

(a) Negotiation and Notice. In the event of any dispute, claim, controversy or
disagreement (each, a “Dispute”) arising out of, in connection with or relating
to this Agreement including any question regarding this Agreement’s existence,
validity or termination, the Parties shall first seek resolution of such Dispute
by negotiation between their respective senior management. Such negotiation
shall be deemed to commence upon the service by either Licensor or BMS upon the
other of a written notice (a “Dispute Resolution Notice”) under this
Section 8.3(a).

 

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(b) If a Dispute subject to negotiation under Section 8.3(a) is not finally
resolved within thirty (30) days following receipt by either Licensor or BMS of
a Dispute Resolution Notice, the Dispute shall be finally resolved by
arbitration under the Rules of Arbitration of the International Chamber of
Commerce (the “ICC”). The arbitral tribunal shall be composed of three
(3) arbitrators. Each of Licensor and BMS shall nominate one (1) arbitrator. The
two arbitrators so nominated shall nominate the presiding arbitrator. If either
Licensor or BMS fails to nominate an arbitrator in its Request for Arbitration
or within thirty (30) days of receiving written notice of the nomination of an
arbitrator by the other Party, such arbitrator shall be appointed by the ICC
Court. If the two (2) arbitrators to be nominated by Licensor and BMS fail to
agree upon a third arbitrator within thirty (30) days of the nomination of the
second arbitrator, the third arbitrator shall be appointed by the ICC Court. The
place of arbitration shall be Paris, France and the language of the arbitration
shall be English. Notwithstanding any provision to the contrary in the ICC Rules
of Arbitration, each Party shall bear its own costs and expenses relating to
such arbitration and all related proceedings, including fees for legal
representation. Each Party shall continue to perform its respective obligations
under this Agreement and this Agreement shall remain in effect while the Dispute
is being resolved. The Parties agree that any dispute arising out of or relating
to this Agreement, the Definitive Agreement, or the Settlement Agreement
(including the China Opt-Out Letter) or any Alliance Agreement (as such terms
are defined in the Definitive Agreement) shall be resolved in a single
arbitration before the ICC, regardless of how many parties or agreements are
implicated, and specifically waive any argument that a dispute arising out of or
relating to this Agreement shall be resolved in multiple arbitrations before the
ICC.

8.4 Specific Performance. Each Party agrees that the Licensed Intellectual
Property is unique, and each Party hereby acknowledges and agrees that it and
the other Party would be damaged irreparably if any of the provisions of this
Agreement are not performed in accordance with their specific terms or otherwise
are breached. Accordingly, each Party shall be entitled to seek specific
performance and/or interim relief, and agrees that the arbitral tribunal
constituted under Section 8.3(b) shall have the power to order specific
performance or grant provisional, interim, or conservatory measures, including
but not limited to provisional injunctive relief. The Parties undertake to
comply forthwith with any such provisional, interim, or conservatory measures
ordered by the arbitral tribunal and agree that such measures may, to the extent
not precluded by applicable law, be enforceable as a final award in any court of
competent jurisdiction. For the avoidance of doubt, nothing in this provision
shall prevent any Party from seeking conservatory or interim measures,
including, but not limited to, temporary restraining orders or preliminary
injunctions or their equivalent, from any court of competent jurisdiction before
the arbitral tribunal is constituted under Section 8.3(b) or, thereafter, upon
the order of the arbitral tribunal.

8.5 No Third Party Beneficiaries. This Agreement shall be binding upon and inure
solely to the benefit of the Parties (including the Sanofi Partner and the BMS
Partner, each in its capacity as a partner of the Partnership) 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.

 

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8.6 Assignment. (a) This Agreement may be assigned by a Party only to an
Affiliate of Licensor 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 Section 3.2 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 Clopidogrel Products (and the
remedy for breach of such diligence requirement shall be termination of such
amended and restated agreement).

8.7 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.

8.8 Waivers and Amendments. No modification of or amendment to this Agreement
shall be valid unless in a writing signed by both 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.

8.9 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.

8.10 Entire Agreement. This Agreement constitutes 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.

 

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8.11 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.

8.12 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.

8.13 Force Majeure. No Party shall be in default under this Agreement, or shall
have any obligation to the other Party, if such Party is unable to perform under
this Agreement by reason of act of God, fire, flood, strike, national emergency
or other contingency beyond its reasonable control (a “Force Majeure”). Such
Party shall give the other Party prompt notice of any interruption of
performance on account of Force Majeure, and of the resumption of such
performance, and shall keep the other Party informed on a current basis as to
the steps being taken to remove, and the anticipated time of removal of, the
circumstances resulting in such Force Majeure. Notwithstanding the foregoing,
nothing in this Section 8.13 shall excuse or suspend the obligation to make any
payment due under this Agreement in the manner and at the time provided herein.

8.14 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.

[Remainder of Page Intentionally Left Blank]

 

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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/ T. Saugier

        Name: T. Saugier         Title: Authorized representative    Represented
by:     

BRISTOL-MYERS SQUIBB

INVESTCO, L.L.C.

     By:   

/s/ Katherine Kelly

        Name: Katherine Kelly         Title: Secretary      Witnessed by:     
SANOFI-AVENTIS U.S. LLC      By:   

/s/ T. Saugier

        Name: T. Saugier         Title: Authorized representative

[Signature Page to Amended and Restated Territory B Clopidogrel License]

 

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SCHEDULE 1A

LICENSED PATENTS

[*][Note: Approximately four pages of text are omitted]

 

Country

   Filing    Application    Grant    Patent    Expiry    Status               
                    

 

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SCHEDULE 1B

LICENSED TRADEMARKS

[*][Table Content Omitted]

 

Trademark

 

Country

 

Type

   Class    Current Status    Filing No.    Filing date    Reg. No.    Reg. date
   Next due date

 

Trademark

 

Country

 

Class

   Current Status    Filing No.    Filing date    Reg. No.    Reg. date   
Next due date

 

 

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