EXHIBIT 10.2

CONFIDENTIAL

EXECUTION COPY

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

COLLABORATION AGREEMENT

THIS COLLABORATION AGREEMENT (the “Agreement”) is made and entered into as of
May 27, 2009 (the “Effective Date”) by and between EXELIXIS, INC., a Delaware
corporation having an address at 170 Harbor Way, P.O. Box 511, South San
Francisco, California 94083-0511 (“Exelixis”), and SANOFI-AVENTIS, a French
company, having an address at 174, Avenue de France, 75013 Paris, France
(“Sanofi-Aventis”). Exelixis and Sanofi-Aventis are sometimes referred to herein
individually as a “Party” and collectively as the “Parties”.

RECITALS

A. Sanofi-Aventis is a leading pharmaceutical company committed to researching,
developing, manufacturing and marketing novel products of high therapeutic value
for human and veterinary medicine.

B. Exelixis is a biotechnology company that has technology and expertise
relating to the discovery and development of therapeutics that modulate signal
transduction pathways involved in oncology and other disease areas.

C. Sanofi-Aventis and Exelixis desire to establish a collaboration to apply
their respective technology and expertise in isoform-specific Class I
phosphoinositide-3-kinases for the development and commercialization of novel
therapeutic and prophylactic products based on such compounds.

NOW, THEREFORE, the Parties agree as follows:

 

1. DEFINITIONS

Capitalized terms used in this Agreement (other than the headings of the
Sections or Articles) have the following meanings set forth in this Article 1,
or, if not listed in this Article 1, the meanings as designated in the text of
this Agreement.

1.1 “Affiliate” means, with respect to a particular Party, a person,
corporation, partnership, or other entity that controls, is controlled by or is
under common control with such Party. For the purposes of the definition in this
Section 1.1, the word “control” (including, with correlative meaning, the terms
“controlled by” or “under the common control with”) means the actual power,
either directly or indirectly through one (1) or more intermediaries, to direct
or cause the direction of the management and policies of such entity, whether by
the ownership of at least fifty percent (50%) of the voting stock of such
entity, or by contract or otherwise.

1.2 “Alliance Manager” has the meaning set forth in Section 4.5(a).

1.3 “Annual Development Plan” has the meaning set forth in Section 5.3(a).

 

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1.4 “Approved Plan” means, with respect to a Product, any one or more of the
Initial Development Plans and each Annual Development Plan, in each case as
adopted or approved under the terms of this Agreement.

1.5 “Calendar Half” means any consecutive 6-month period ending June 30 or
December 31.

1.6 “Calendar Quarter” means any consecutive 3-month period ending
March 31, June 30, September 30 or December 31.

1.7 “Calendar Year” means any consecutive 12-month period ending December 31.

1.8 “Clinical Supply Requirements” means the quantities of the Product which are
required by a Party or the Parties for the Development of a Product under this
Agreement, including, without limitation, the conduct of research, pre-clinical
studies and clinical trials in connection with each Annual Development Plan.

1.9 “CMC Activities” has the meaning set forth in Section 7.2(b).

1.10 “Collaboration” means all the activities performed by or on behalf of
either Exelixis or Sanofi-Aventis in the course of performing work contemplated
in Articles 2, 3, 4, 5, 6 and 7.

1.11 “Collaboration Compound” means: (a) Lead Compounds; (b) Development
Candidates; or (c) any isomer, racemate, salt, solvate, hydrate, metabolite,
conjugate, co-crystals, polymorphs, ester, or prodrug of the compounds set forth
in clause (a) or (b) of this definition.

1.12 “Collaborative Research Term” shall mean the period beginning on the
Effective Date and continuing until the third (3rd) anniversary of the Effective
Date. The Collaborative Research Term may be further extended beyond its initial
period pursuant to Section 2.5 or upon the mutual written agreement of the
Parties.

1.13 “Commercialize” means to promote, market, distribute, sell (and offer for
sale or contract to sell) or provide product support for a Product, including by
way of example: (a) detailing and other promotional activities in support of a
Product; (b) advertising and public relations in support of a Product, including
market research, development and distribution of selling, advertising and
promotional materials, field literature, direct-to-consumer advertising
campaigns, media/journal advertising, and exhibiting at seminars and
conventions; (c) developing reimbursement programs and information and data
specifically intended for national accounts, managed care organizations,
governmental agencies (e.g., federal, state and local), and other group
purchasing organizations, including pull-through activities; (d) other
co-promotion activities not included in the above; (e) conducting medical
education activities and journal advertising; and (f) [ * ]. For clarity,
“Commercializing” and “Commercialization” have a correlative meaning.

1.14 “Committee” means the JEC or JRDC, as the case may be.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.15 “Confidential Information” has the meaning set forth in Section 11.1.

1.16 “Contractual Joint Patent” means any Exelixis Patent, Sanofi-Aventis Patent
or Joint Invention Patent that [ * ].

1.17 “Controlled” means, with respect to any compound, material, Information or
intellectual property right, that the Party owns or has a license to such
compound, material, Information or intellectual property right and has the
ability to grant to the other Party access, a license or a sublicense (as
applicable) to such compound, material, Information or intellectual property
right as provided for herein without violating the terms of any agreement or
other arrangements with any Third Party existing at the time such Party would be
first required hereunder to grant the other Party such access, license or
sublicense.

1.18 “Development” means, with respect to a Product, those activities, including
clinical development activities, clinical trials, supporting manufacturing
activities and related regulatory activities, that are [ * ] to: (a) obtain,
from the appropriate Regulatory Authorities, the Regulatory Approvals with
respect to such Product in the applicable regulatory jurisdiction, whether alone
or for use together, or in combination, with another active agent or
pharmaceutical product; and (b) maintain such Regulatory Approvals. To avoid
confusion, Development does not include [ * ]. For clarity, “Develop” and
“Developing” have a correlative meaning.

1.19 “Development Candidate” means any former Lead Compound that: (a) is a PI3Ka
Selective Inhibitor, PI3Kß Selective Inhibitor, PI3Ka/ß Inhibitor, PI3Ka/mTOR
Inhibitor, PI3Kß/mTOR Inhibitor, or PI3Ka/ß/mTOR Inhibitor; (b) has met the
Development Candidate Criteria set forth in the Research Plan (or has otherwise
been nominated by the JRDC pursuant to Section 2.3(e)); and (c) [ * ]. For
clarity, a Lead Compound ceases to be a Lead Compound after it has been approved
as a Development Candidate.

1.20 “Development Candidate Nomination Criteria” has the meaning set forth in
Section 5 of Exhibit 2.2.

1.21 “Diligent Efforts” means the carrying out of obligations or tasks by a
Party in a sustained manner using good faith commercially reasonable and
diligent efforts, which efforts shall be consistent with the exercise of prudent
scientific and business judgment in accordance with the efforts such Party
devotes to products or research or development projects owned by it of similar
scientific and commercial potential. Diligent Efforts shall be [ * ].

1.22 “Dollars” or “$” means the legal tender of the United States of America.

1.23 “Drug Approval Application” or “DAA” means: in any country or regulatory
jurisdiction, the application for Regulatory Approval required for commercial
sale or use of a Product (or with respect to a subsequent Indication) in such
country or regulatory jurisdiction.

1.24 “Exelixis Clinical Trials” means the clinical trials that are carried out
by Exelixis for each Product and that are described in the Global Development
Plan or each Annual Development Plan, and any other trials that are designated
as Exelixis Clinical Trials by the JRDC.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.25 “Exelixis Development Expenses” means those costs and expenses incurred by
Exelixis directly in connection with the Development of a Product in accordance
with this Agreement and the applicable Annual Development Plan, including
without limitation:

(i) all Out-of-Pocket Costs, including, without limitation, fees and expenses
associated with the conduct of Exelixis Clinical Trials or any other mutually
agreed Development activities with respect to a Product (e.g., fees paid to
CROs, purchase of comparator or placebo);

(ii) Exelixis FTE Costs; and

(iii) any other costs or expenses [ * ] incurred in connection with any other
mutually agreed research or Development activities of Exelixis with respect to a
Product.

1.26 “Exelixis FTE Cost” means, for all Development activities performed by
Exelixis in accordance with the Annual Development Plan(s), the amount equal to
(a) the number of FTEs required for such Development activity as set forth in
the approved Annual Development Plan multiplied by (b) the Exelixis FTE Rate.
For the avoidance of doubt, the activity of contract personnel shall be charged
as Out-of-Pocket Costs.

1.27 “Exelixis FTE Rate” means [ * ], subject to adjustment in accordance with
Section 5.5(d).

1.28 “Exelixis Know-How” means all Information Controlled by Exelixis (other
than Exelixis Patents) and its Affiliates as of the Effective Date or during the
Term that: (a) covers a Collaboration Compound, a composition containing a
Collaboration Compound, a formulation containing a Collaboration Compound, or
the manufacture or use of a Collaboration Compound; and (b) is [ * ] for
Sanofi-Aventis to exercise the rights licensed to it under the Agreement or to
perform its obligations under the Agreement.

1.29 “Exelixis Patents” means all Patents Controlled by Exelixis and its
Affiliates, as of the Effective Date or during the Term, including Sole
Invention Patents Controlled by Exelixis that: (a) cover a Collaboration
Compound, a composition containing a Collaboration Compound, a formulation
containing a Collaboration Compound, or the manufacture or use of a
Collaboration Compound; and (b) are [ * ] for Sanofi-Aventis to exercise the
rights licensed to it under the Agreement or to perform its obligations to the
Collaboration under the Agreement.

1.30 “Exelixis Prosecuted Patents” has the meaning set forth in
Section 10.3(a)(i).

1.31 “FDA” means the United States Food and Drug Administration, and any
successor thereto.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.32 “FTE” means the equivalent of the work of one (1) employee full time for
one (1) year consisting of a total of [ * ] hours per year directly related to
the research or Development of any Pre-Lead Compound, Lead Compound, Development
Candidate, or Product or any other activities contemplated under this Agreement.
Any individual who devotes less than [ * ] hours per year (or such other number
as may be agreed by the JEC) shall be treated as an FTE on a pro-rata basis upon
the number of hours worked (based on Exelixis’ internal methodology for
calculating the number of hours that comprises an FTE) divided by [ * ] hours.

1.33 “Generic Product” means, with respect to a given Product in a given
country, any pharmaceutical product that: (a) is marketed for sale in such
country by a Third Party; (b) contains as active pharmaceutical ingredient [ *
]; and (c) [ * ]. With respect to a Product that is [ * ], a Generic Product
shall, for purposes of this paragraph, contain as active pharmaceutical
ingredients [ * ], and meet the conditions defined in (a) and (c) above.

1.34 “GAAP” means United States generally accepted accounting principles, as
they exist from time to time, consistently applied.

1.35 “IFRS” means International Financial Reporting Standards, as they exist
from time to time, consistently applied.

1.36 “IND” means an Investigational New Drug Application submitted to the FDA in
conformance with applicable laws and regulations, or the foreign equivalent of
any such application in any other country.

1.37 “IND Submission Criteria” has the meaning set forth in Section 7 of Exhibit
2.2.

1.38 “Indication” means:

(a) with respect to the oncology therapeutic area, [ * ] (for clarification
purposes, (i) [ * ]; and (ii) [ * ]); or,

(b) any disease in therapeutic areas other than oncology.

1.39 “Information” means information, results and data of any type whatsoever,
in any tangible or intangible form whatsoever, including, databases, practices,
methods, techniques, specifications, formulations, formulae, knowledge,
know-how, skill, experience, test data including pharmacological, biological,
chemical, biochemical, toxicological and clinical test data, analytical and
quality control data, stability data, studies and procedures. For clarity,
Information excludes any Patents.

1.40 “Initial Development Plan” has the meaning set forth in Section 5.2(a).

1.41 “Invention” means any and all inventions and improvements conceived or
reduced to practice by or on behalf of a Party or the Parties jointly in the
performance of its obligations, or the exercise of its rights, under this
Agreement.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.42 “Joint Executive Committee” or “JEC” has the meaning set forth in
Section 4.1(a).

1.43 “Joint Research & Development Committee” or “JRDC” has the meaning set
forth in Section 4.1(a).

1.44 “Joint Invention” means any Invention conceived and/or reduced to practice
jointly by or on behalf of both Parties.

1.45 “Joint Invention Patent” means (i) a Patent that claims a Joint Invention
or (ii) a Contractual Joint Patent.

1.46 “Knowledge” means, with respect of a Party, the [ * ] facts and information
in the possession of [ * ] of such Party, or any [ * ], or [ * ], such Party or
its Affiliates, [ * ] execution of this Agreement. For purposes of this
definition, [ * ] means any person in the [ * ] of a Party.

1.47 “Launch” means, for each Product in each country, the first arm’s-length
sale to a Third Party for use or consumption by the public of such Product in
such country after Regulatory Approval of such Product in such country. A Launch
shall not include any Product sold for use in clinical trials, for research or
for other non-commercial uses, or [ * ].

1.48 “Lead Compound” means any: (a) former Pre-Lead Compound that: (i) is a
PI3Ka Selective Inhibitor, PI3Kß Selective Inhibitor, PI3Ka/ß Inhibitor,
PI3Ka/mTOR Inhibitor, PI3Kß/mTOR Inhibitor, or PI3Ka/ß/mTOR Inhibitor; (ii) has
met the Lead Compound Nomination Criteria set forth in the Research Plan (or has
otherwise been nominated by the JRDC pursuant to Section 2.3(c)); and (iii) has
been approved by the JRDC pursuant to Section 2.3(c); or (b) small molecule
compound Controlled by a Party that: (i) is [ * ]; (ii) is a PI3Ka Selective
Inhibitor, PI3Kß Selective Inhibitor, PI3Ka/ß Inhibitor, PI3Ka/mTOR Inhibitor,
PI3Kß/mTOR Inhibitor, or PI3Ka/ß/mTOR Inhibitor; (iii) has met the Lead Compound
Nomination Criteria set forth in the Research Plan (or has otherwise been
nominated by the JRDC pursuant to Section 2.3(c)); and (iv) has been approved by
the JRDC pursuant to Section 2.3(c). For clarity, [ * ].

1.49 “Lead Compound Nomination Criteria” has the meaning set forth in Section 3
of Exhibit 2.2.

1.50 “Lead Development Party” has the meaning set forth in Section 5.1.

1.51 “Lead Optimization Responsibilities” has the meaning set forth in Section 4
of Exhibit 2.2.

1.52 “Losses” has the meaning set forth in Section 14.1.

1.53 “MAD” has the meaning set forth in the definition of “Transfer Date”.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.54 “Major European Countries” means France, Germany, Italy, Spain and the
United Kingdom.

1.55 “Major Territory” means each of the following territories: [ * ].

1.56 “Manufacturing” means all activities related to the production,
manufacture, processing, filling, finishing, packaging, labeling, inspection,
receiving, holding and shipping of Collaboration Compounds, Products, or any raw
materials or packaging materials with respect thereto, or any intermediate of
any of the foregoing, including process and cost optimization, process
qualification and validation, commercial manufacture, stability and release
testing, quality assurance and quality control. For clarity, “Manufacture” has a
correlative meaning.

1.57 “MTD” has the meaning set forth in the definition of “Transfer Date”.

1.58 “mTOR” means: (a) the gene for [ * ]; (b) the protein encoded by such gene;
and (c) all [ * ].

1.59 “Net Sales” means the amount invoiced or otherwise billed by Sanofi-Aventis
or its Affiliate or sublicensee for sales or other commercial disposition of a
Product to a Third Party purchaser, less the following to the extent included in
such billing or otherwise actually allowed or incurred with respect to such
sales: (a) discounts, including cash, trade and quantity discounts, price
reduction programs, retroactive price adjustments with respect to sales of a
Product, charge-back payments and rebates granted to managed health care
organizations or to federal, state and local governments (or their respective
agencies, purchasers and reimbursers) or to trade customers, including but not
limited to, wholesalers and chain and pharmacy buying groups; (b) credits or
allowances actually granted upon rejections or returns of Products, including
for recalls or damaged goods; (c) freight, postage, shipping and insurance
charges actually allowed or paid for delivery of Products, to the extent billed;
(d) customs duties, surcharges and other governmental charges incurred in
connection with the exportation or importation of a Product; (e) bad debts
relating to sales of Products that are actually written off by Sanofi-Aventis in
accordance with IFRS, consistently applied, during the applicable royalty
calculation period; and (f) taxes, duties or other governmental charges levied
on, absorbed or otherwise imposed on sale of Products, including value-added
taxes, or other governmental charges otherwise measured by the billing amount,
when included in billing, as adjusted for rebates and refunds, but specifically
excluding taxes based on net income of the seller; provided that all of the
foregoing deductions are calculated in accordance with IFRS.

Notwithstanding the foregoing, if any Product is sold [ * ], then, solely for
the purpose of calculating Net Sales for royalty purposes hereunder, any [ * ]
on such Products [ * ] shall be [ * ] for the applicable accounting period. In
case of any dispute as to the applicable [ * ] under the preceding sentence, the
determination of same shall be calculated and certified by [ * ], whose decision
shall be binding.

A sale of a Product is deemed to occur upon invoicing. [ * ].

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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For sake of clarity and avoidance of doubt, sales by Sanofi-Aventis, its
Affiliates or sublicensees of a Product to [ * ]. Any Products [ * ] considered
in determining Net Sales hereunder.

In the event a Product is sold as an end-user product consisting of a
combination of active functional elements or as a combined product and/or
service, Net Sales, for purposes of determining royalty payments on such
Product, shall be calculated by multiplying the Net Sales of the end-user
product and/or service by the fraction A over A+B, in which A is the gross
selling price of the Product portion of the end-user product and/or service when
such Product is sold separately during the applicable accounting period in which
the sales of the end-user product were made, and B is the gross selling price of
the other active elements and/or service, as the case may be, of the end-user
product and/or service sold separately during the accounting period in question.
All gross selling prices of the elements of such end-user product and/or service
shall be calculated as the average gross selling price of the said elements
during the applicable accounting period for which the Net Sales are being
calculated. In the event that, in any country or countries, no separate sale of
either such above-designated Product or such above designated elements of the
end-user product and/or service are made during the accounting period in which
the sale was made or if gross retail selling price for an active functional
element, component or service, as the case may be, cannot be determined for an
accounting period, Net Sales allocable to the Product in each such country shall
be determined by mutual agreement reached in good faith by the Parties prior to
the end of the accounting period in question based on an equitable method of
determining same that takes into account, on a country-by-country basis,
variations in potency, the relative contribution of each active agent, component
or service, as the case may be, in the combination, and relative value to the
end user of each active agent, component or service, as the case may be.
Notwithstanding the foregoing, the Parties agree that, for purposes of this
paragraph, adjuvants, mechanical but not chemical drug delivery devices, and
excipients shall not be deemed to be “active ingredients” or “active functional
elements”. For clarity, [ * ] such as, without limitation, [ * ] to be “active
ingredients” or “active functional elements” for purposes of this paragraph.

1.60 “Out-of-Pocket Costs” means costs and expenses paid to Third Parties (or
payable to Third Parties and accrued in accordance with GAAP) by Exelixis and/or
its Affiliates, if applicable.

1.61 “Party Vote” has the meaning set forth in Section 4.4(c)(i).

1.62 “Patent” means all: (a) unexpired letters patent (including inventor’s
certificates) which have not been held invalid or unenforceable by a court of
competent jurisdiction from which no appeal can be taken or has been taken
within the required time period (and which have not been admitted to be invalid
or unenforceable through reissue, disclaimer or otherwise, or been abandoned in
accordance with or as permitted by the terms of this Agreement or by mutual
written agreement), including any substitution, extension, registration,
confirmation, reissue, re-examination, supplementary protection certificates,
confirmation patents, patent of additions, renewal or any like filing thereof;
(b) pending applications for letters patent which have not been canceled,
withdrawn from consideration, finally determined to be unallowable by the
applicable governmental authority or court for whatever reason (and from which
no appeal is or can be taken), and/or abandoned in accordance with or as
permitted by the terms of this Agreement or by mutual written consent, including
any continuation, division or continuation-in-part thereof and any provisional
applications; and (c) any international counterparts to (a) and (b) above.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.63 “Phase I Clinical Trial” means a clinical trial that generally provides for
the first introduction into humans of a Product, with a primary purpose of
determining safety, metabolism and pharmacokinetic properties and clinical
pharmacology of such Product, and generally consistent with 21 CFR § 312.21(a),
as amended (or its successor regulation), or other comparable regulation imposed
by a Regulatory Authority in any country.

1.64 “Phase I/II Clinical Trial” means a human clinical trial of a Product,
which trial satisfies the requirements for a Phase I Clinical Trial and for a
Phase II Clinical Trial.

1.65 “Phase II Clinical Trial” means a human clinical trial of a Product, the
principal purpose of which is to make a preliminary determination that such
Product is safe for its intended use and to obtain sufficient information about
such Product’s efficacy to permit the design of further clinical trials, and
generally consistent with 21 CFR § 312.21(b), as amended (or its successor
regulation), or other comparable regulation imposed by a Regulatory Authority in
any country.

1.66 “Phase II/III Clinical Trial” means a human clinical trial of a Product,
that satisfies the requirements for a Phase II Clinical Trial and for a Phase
III Clinical Trial.

1.67 “Phase III Clinical Trial” means a pivotal human clinical trial of a
Product, which trial is designed to: (a) establish that such Product is safe and
efficacious for its intended use; (b) define warnings, precautions and adverse
reactions that are associated with such Product in the dosage range to be
prescribed; (c) support Regulatory Approval of such Product; and (d) be
generally consistent with 21 CFR § 312.21(c), as amended (or its successor
regulation), or other comparable regulation imposed by a Regulatory Authority in
any country.

1.68 “Phase IIIB Clinical Trial” means a clinical trial of a Product, initiated
before regulatory approval and is not required for same, but which may provide
data that further defines how and where the drug should be used. A Phase IIIB
Clinical Trial may include epidemiological studies, modeling and
pharmacoeconomic studies, and investigator-sponsored clinical trials that are
approved by the JRDC and that otherwise fit the foregoing definition.

1.69 “Phase IV Clinical Trial” means a product support clinical trial of a
Product commenced after receipt of Regulatory Approval in the country where such
trial is conducted. A Phase IV Clinical Trial may include epidemiological
studies, modeling and pharmacoeconomic studies, and investigator-sponsored
clinical trials studying Product that are approved by the JRDC and that
otherwise fit the foregoing definition.

1.70 “PI3K” means: (a) the gene encoding [ * ]; (b) the protein encoded by such
gene; and (c) all [ * ]. For the purposes of this Agreement the term “PI3K”
refers to [ * ].

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.71 “PI3Ka Selective Inhibitor” means a small molecule compound that:
(a) inhibits PI3Ka at the applicable Target Potency Threshold; and (b) meets the
applicable Target Specificity Threshold.

1.72 “PI3Ka/ß Inhibitor” means a small molecule compound that: (a) inhibits
PI3Ka and PI3Kß at the applicable Target Potency Threshold; and (b) meets the
applicable Target Specificity Threshold.

1.73 “PI3Ka/ß/mTOR Inhibitor” means a small molecule compound that: (a) inhibits
PI3Ka, PI3Kß and mTOR at the applicable Target Potency Threshold; and (b) meets
the applicable Target Specificity Threshold.

1.74 “PI3Ka/mTOR Inhibitor” means a small molecule compound that: (a) inhibits
PI3Ka and mTOR at the applicable Target Potency Threshold; and (b) meets the
applicable Target Specificity Threshold.

1.75 “PI3Kß Selective Inhibitor” means a small molecule compound that:
(a) inhibits PI3Kß at the applicable Target Potency Threshold; and (b) meets the
applicable Target Specificity Threshold.

1.76 “PI3Kß/mTOR Inhibitor” means a small molecule compound that: (a) inhibits
PI3Kß and mTOR at the applicable Target Potency Threshold; and (b) meets the
applicable Target Specificity Threshold.

1.77 “Pre-Lead Compound” means a small molecule compound that: (a) [ * ];
(b) such Party has [ * ] (as applicable); (c) meets the Pre-Lead Criteria set
forth in the Research Plan; and (d) is [ * ] to the JRDC for inclusion under the
Agreement as a Collaboration Compound.

1.78 “Pre-Lead Criteria” has the meaning set forth in Section 2 of Exhibit 2.2.

1.79 “Product” means any therapeutic or prophylactic product (for use in animals
or humans) in bulk or finished form that comprises or incorporates any [ * ].

1.80 “Regulatory Approval” means any and all approvals (including supplements,
amendments, pre- and post-approvals, pricing and reimbursement approvals),
licenses, registrations or authorizations of any national, supra-national (e.g.,
the European Medicines Agency (“EMEA”)), regional, state or local regulatory
agency, department, bureau, commission, council or other governmental entity,
that are necessary for the manufacture, distribution, use or sale of a Product
in a regulatory jurisdiction.

1.81 “Regulatory Authority” means the applicable national (e.g., the FDA),
supra-national (e.g., the EMEA), regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity that, in
each case, governs the Regulatory Approval of a Product in such applicable
regulatory jurisdiction.

1.82 “Research Plan” has the meaning set forth in Section 2.2.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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1.83 “Royalty Term” has the meaning set forth in Section 9.5.

1.84 “[ * ]” has the meaning set forth in Section 4.4(c)(iv).

1.85 “Sanofi-Aventis Know-How” means all Information Controlled by
Sanofi-Aventis (other than Sanofi-Aventis Patents) and its Affiliates as of the
Effective Date or during the Term, that: (a) covers a Collaboration Compound, a
composition containing a Collaboration Compound, a formulation containing a
Collaboration Compound, or the manufacture or use of a Collaboration Compound;
and (b) is [ * ] for Exelixis to exercise the rights licensed to it under the
Agreement or to perform its obligations under the Agreement.

1.86 “Sanofi-Aventis Patents” means all Patents Controlled by Sanofi-Aventis and
its Affiliates (including Sanofi-Aventis’ Sole Invention Patents but excluding
Exelixis Patents), as of the Effective Date or during the Term, including any
Sole Invention Patents Controlled by Sanofi-Aventis, that: (a) cover a
Collaboration Compound, a composition containing a Collaboration Compound, a
formulation containing a Collaboration Compound, or the manufacture or use of a
Collaboration Compound; and (b) are [ * ] for Exelixis to exercise the rights
licensed to it under the Agreement or to perform its obligations under the
Agreement.

1.87 “SAR” has the meaning set forth in Section 2.3(b).

1.88 “Selectivity Panel” has the meaning described in Exhibit 1.88.

1.89 “Sole Invention” means any Invention conceived and reduced to practice
solely by or on behalf of a Party during the Term.

1.90 “Sole Invention Patent” means a Patent that claims a Sole Invention.

1.91 “Target Potency Threshold” has the meaning set forth in Exhibit 1.91.

1.92 “Target Specificity Threshold” has the meaning set forth in Exhibit 1.92.

1.93 “Term” has the meaning set forth in Section 12.1.

1.94 “Third Party” means any person or entity other than: (a) Exelixis;
(b) Sanofi-Aventis; or (c) an Affiliate of either Party.

1.95 “Transfer Date” for a given Exelixis Clinical Trial with respect to any
given Product means: (a) the date on which Exelixis notifies Sanofi-Aventis of
the first occurrence of any of the following events: (i) [ * ]; and (ii) [ * ];
or (b) the date on which [ * ].

1.96 “Upstate Panel” has the meaning described in Exhibit 1.88.

1.97 “Valid Claim” means (a) a claim in an issued Patent that has not:
(i) expired or been canceled; (ii) been declared invalid by an unreversed and
unappealable or unappealed decision of a court or other appropriate body of
competent jurisdiction; (iii) been admitted to be

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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invalid or unenforceable through reissue, disclaimer or otherwise; or (iv) been
abandoned in accordance with or as permitted by the terms of this Agreement or
by mutual written agreement of the Parties; or (b) a claim under an application
for a Patent that has been pending [ * ], and which has not been canceled,
withdrawn from consideration, finally determined to be unallowable by the
applicable governmental authority or court for whatever reason (and from which
no appeal is or can be taken), or abandoned.

1.98 “Working Group” has the meaning set forth in Section 4.4(f).

 

2. COLLABORATION

2.1 Overview; Guidelines; and Independence.

(a) Overview. The Parties desire to apply their respective technology and
expertise to discover, optimize and advance Collaboration Compounds that are a
PI3Ka Selective Inhibitor, PI3Kb Selective Inhibitor, PI3Ka/b Inhibitor,
PI3Ka/mTOR Inhibitor, PI3Kb/mTOR Inhibitor, or PI3Ka/b/mTOR Inhibitor so that
such Collaboration Compounds may be Developed into Products and Commercialized
by Sanofi-Aventis. As a general goal, the Parties intend to advance [ * ] Lead
Compounds as Development Candidates, and to submit [ * ] INDs on Development
Candidates ([ * ]), during the Collaborative Research Term. The Parties agree
that failure to advance [ * ] such Lead Compounds as Development Candidates, or
failure to submit [ * ] such INDs on Development Candidates shall not be treated
as a breach of this Agreement. Each Party shall have responsibilities under the
Collaboration in accordance with the allocation of duties set forth in the
Research Plan, including responsibilities for lead optimization, preclinical
development of Collaboration Compounds, and conduct of [ * ] Clinical Trial(s)
for such Collaboration Compounds.

(b) Resources. Each Party shall assign responsibilities for the various
operational aspects of the Collaboration to those portions of its organization
that have the appropriate resources, expertise and responsibility for such
functions and, consistent with this Agreement, treat each Pre-Lead Compound,
Lead Compound or Development Candidate as if it were a proprietary compound
solely of its own organization. In all matters related to the Collaboration, the
Parties shall strive to balance as best as they can the legitimate interests and
concerns of the Parties and to realize the full economic potential of each
Product (taking into account the risks and costs of further Development and
Commercialization). Notwithstanding anything to the contrary, during the
Collaborative Research Term, Exelixis shall allocate and utilize [ * ] FTEs per
year, [ * ] to fulfilling its obligations under the Research Plan, and
Sanofi-Aventis shall allocate [ * ] to perform its obligations under the
Research Plan.

2.2 Research Plan. The Parties have agreed in writing upon an initial plan for
the research to be carried out by the Parties during the Collaborative Research
Term, which is set forth in the Exhibit 2.2 and incorporated herein by reference
(the “Research Plan”). The Research Plan includes each Party’s respective
obligations in furtherance of the Collaboration

 

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and timelines for completion of key stages. The JRDC shall review the Research
Plan at least [ * ] and may propose to the JEC (for its review and approval)
revised versions of the Research Plan that do not contradict any terms of this
Agreement. Once approved by the JEC, such revised Research Plan shall replace
the prior Research Plan. If the terms of the Research Plan contradict, or create
inconsistencies or ambiguities with, the terms of this Agreement, then the terms
of this Agreement shall govern.

2.3 Conduct of Research.

(a) General. The Parties shall use Diligent Efforts to conduct their respective
tasks set forth in the Research Plan and shall conduct the Collaboration in good
scientific manner, and in compliance in all material respects with the
requirements of applicable laws, rules and regulations and all applicable good
laboratory practices.

(b) Pre-Lead Discovery and Nomination. During the Collaborative Research Term,
each Party shall use Diligent Efforts to [ * ]. Each Party shall [ * ]
identification and characterization (but not [ * ]) with the JRDC at each
meeting. Exhibit 2.3(b)(i) identifies (as of the Effective Date) a list of
compounds that [ * ], and Exhibit 2.3(b)(ii) identifies (as of the Effective
Date) a list of compounds that [ * ]. Once [ * ] a given compound meets the
Pre-Lead Compound Nomination Criteria identified in the Research Plan, then [ *
] shall submit to the JRDC a data package (excluding [ * ]) for nominating such
compound as a Pre-Lead Compound. Alternatively, the JRDC may request [ * ] to
assemble and submit ([ * ]) a data package (excluding [ * ]) for any PI3Ka
Selective Inhibitor, PI3Kb Selective Inhibitor, PI3Ka/b Inhibitor, PI3Ka/mTOR
Inhibitor, PI3Kb/mTOR Inhibitor, or PI3Ka/bmTOR Inhibitor that has been
disclosed to the JRDC by [ * ]. The JRDC shall review each data package
submitted for Pre-Lead Compound nomination and shall determine whether to
approve such compound as a Pre-Lead Compound. If the JRDC approves such
compound, then such compound shall be deemed to be a Pre-Lead Compound. Upon
such approval by the JRDC, the [ * ] for such Pre-Lead Compound shall be [ * ].
If the JRDC does not approve a compound as a Pre-Lead Compound, and the JRDC
recommends that such compound should be subject to additional work, then, [ * ];
provided, however, that the JRDC shall have the sole discretion to prioritize
such additional work relative to any work being performed [ * ]. If the JRDC
does not approve such compound as a Pre-Lead Compound and does not recommend
additional work, then such compound shall [ * ] further research, develop or
commercialize such compound [ * ].

(c) Lead Discovery and Nomination. Once [ * ] Pre-Lead Compound meets the Lead
Compound Nomination Criteria identified in the Research Plan, then [ * ] shall
submit to the JRDC a data package for such Pre-Lead Compound to be approved as a
Lead Compound by the JRDC. Alternatively, the JRDC may nominate a Pre-Lead
Compound for consideration to be a Lead Compound and request [ * ] to assemble
and submit ([ * ]) a data package for such Pre-Lead Compound. The JRDC shall
review each submitted data package and shall determine whether to approve such
Pre-Lead Compound as a Lead Compound, provided, however, that prior to such
determination, [ * ] shall have the right to request and receive, [ * ]. If the
JRDC approves such Pre-Lead Compound, then such Pre-Lead Compound shall be
deemed to be a Lead Compound, and shall no longer be deemed to be a Pre-Lead
Compound. If the JRDC does

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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not approve a Pre-Lead Compound, and the JRDC recommends that such Pre-Lead
Compound should be subject to additional work, then, [ * ]; provided, however,
that the JRDC shall have the sole discretion to prioritize such additional work
relative to any work being performed [ * ]. If JRDC does not approve such
Pre-Lead Compound and does not recommend additional work, then such Pre-Lead
Compound shall cease to be a Pre-Lead Compound, and [ * ].

(d) Review of Lead Compounds. As part of the criteria for the submission of a
Lead Compound for approval as a Development Candidate, [ * ] review the results
of all screening assays for [ * ]. [ * ]. If [ * ], then [ * ]; provided,
however, that [ * ]. For clarity, (a) nothing in this Section 2.3 shall be
deemed to [ * ], and (b) [ * ]. In the event that [ * ], then [ * ].

(e) Lead Optimization. During the Collaborative Research Term, the JRDC shall
review and prioritize each Lead Compound on a regular basis, allocating the
split of responsibilities and resources between the Parties with the goal of
advancing a prioritized Lead Compound to Development Candidate by the conduct of
the Lead Optimization Responsibilities set forth in the Research Plan, and the
factors described below. In general, the responsibilities for [ * ] of a Lead
Compound and associated [ * ] shall remain with [ * ]; provided, however, that
the Parties may agree to allocate some activities (and transfer Lead Compounds)
to [ * ]. During the Collaborative Research Term, each Party shall [ * ] update
the JRDC with the progress and results of such conduct. The JRDC shall assess
the status of the Lead Compounds, and, if a Lead Compound meets the Development
Candidate Nomination Criteria, or if the JRDC otherwise determines that a Lead
Compound should be advanced as a Development Candidate for preclinical
development, then the JRDC shall nominate such Lead Compound as a Development
Candidate to [ * ]. [ * ] shall promptly (and in good faith) review such
nomination and determine whether such Lead Compound shall be advanced for
preclinical development by becoming a Development Candidate. If [ * ] determines
to approve such Lead Compound as a Development Candidate, then [ * ] shall
promptly notify the JRDC, and such Lead Compound shall be deemed to be a
Development Candidate and shall no longer be deemed to be a Lead Compound. [ * ]
shall also determine which Party would be responsible for CMC Activities,
preclinical development, IND submission and conduct of the first Phase I
Clinical Trial for such Development Candidate. If the JRDC decides not to
nominate a Lead Compound as a Development Candidate, or if [ * ] does not
approve a Lead Compound as a Development Candidate, and the JRDC [ * ]
recommends additional work to be performed on such Lead Compound, then, [ * ]
shall use Diligent Efforts to conduct such additional work and re-submit such
Lead Compound to the JRDC; provided, however, that the JRDC shall have the sole
discretion to prioritize such additional work relative to any work being
performed by such Party under this Agreement.

(f) Preclinical Development and IND Submission. After [ * ] determines to
advance a Lead Compound as a Development Candidate, [ * ] shall use Diligent
Efforts during the Collaborative Research Term to conduct the Preclinical
Development Activities set forth in the Research Plan. The JRDC shall assess the
status of such Preclinical Development Activities, and, if a Development
Candidate meets the IND Submission Criteria, or if the JRDC otherwise determines
that an IND should be submitted for a Development Candidate, then the JRDC shall
nominate such Development Candidate for IND submission to [ * ]. [ * ] shall
promptly (and in

 

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amended.

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good faith) review such nomination and determine whether an IND should be
submitted for such Development Candidate. If [ * ] determines that an IND should
be submitted, then [ * ] shall promptly notify the JRDC, and the Lead
Development Party shall prepare the Initial Development Plan and Annual
Development Plan pursuant to Article 5. After the Initial Development Plan and
Annual Development Plan are finalized, the Lead Development Party shall use
Diligent Efforts to prepare and submit to the applicable Regulatory Authority
the IND package for such Development Candidate. If the JRDC determines that an
IND should not be submitted for a Development Candidate, or if [ * ] determines
not to submit an IND for a Development Candidate, but if either the JRDC or [ *
] recommends that such Development Candidate should be subject to additional
work, then, [ * ] shall use Diligent Efforts to conduct such additional work and
re-submit such Development Candidate to the JRDC [ * ]; provided, however, that
the JRDC shall have the sole discretion to prioritize such additional work
relative to any work being performed [ * ]. After the INDs for at least [ * ]
Development Candidates, have been approved by the appropriate Regulatory
Authority [ * ] shall have any obligation to submit (or conduct any work related
to the submission of) any additional INDs for any other Development Candidates,
and [ * ] shall have any obligation to submit (or conduct any work related to
the submission of) any additional Lead Compounds for advancement as Development
Candidates.

(g) Expenses and Reimbursement.

(i) Collaborative Research Term. Subject to Section 4.1(b)(ii) and
Section 9.1(b), [ * ] shall bear [ * ] costs and expenses associated with each
Collaboration Compound for the conduct of [ * ] tasks described in the Research
Plan, until [ * ]. Such expenses shall include [ * ].

(ii) Development. Sanofi-Aventis shall bear the costs and expense (and reimburse
Exelixis) associated with conducting clinical development of a Development
Candidate incurred after the approval of the applicable IND, including any
Exelixis Development Expenses incurred after the approval of the applicable IND;
provided, however, [ * ].

2.4 Information Exchange; Reports. During the Collaborative Research Term, each
Party shall report to the JRDC no less than [ * ] and shall submit to the other
Party and the JRDC a [ * ] written progress report summarizing the results and
data obtained from the conduct of the Research Plan. Notwithstanding anything to
the contrary in this Agreement, neither Party shall be obligated to [ * ]. If
reasonably necessary for a Party to perform its work under the Research Plan or
to exercise its rights under the Agreement, such Party may request that the
other Party provide more detailed information and data regarding such results
reported by such other Party, and such other Party shall promptly provide the
requesting Party with information and data as is reasonably related to such
request, including any records created by a Party pursuant to Section 13.3(c).
All such reports shall be considered Confidential Information of the Party
providing same.

 

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2.5 Option to Extend Collaborative Research Term. Provided [ * ] is not [ * ], [
* ] shall have the right to extend the Collaborative Research Term for an
additional [ * ] period, upon a minimum of [ * ] written notice prior to the
expiry of the Collaborative Research Term on the same terms and conditions in
this Agreement (except that [ * ] shall not have the ability to make additional
unilateral extensions to the Collaborative Research Term). [ * ] may, at its
option, request that [ * ] execute an extension agreement in order to formalize
the extension of the Collaborative Research Term, but [ * ]. Subsequent to such
[ * ] extension, the Parties may extend the Collaborative Research Term solely [
* ].

 

3. SANOFI-AVENTIS DEVELOPMENT AND COMMERCIALIZATION RESPONSIBILITIES

3.1 Scope. Except for the Exelixis’ responsibilities under the Research Plan and
the Exelixis Clinical Trials, Sanofi-Aventis shall have sole control and
responsibility for the Development, Manufacture (including formulation, but
subject to Section 7.1) and Commercialization of all Collaboration Compounds
and/or Products. Sanofi-Aventis shall bear all costs and expenses associated
with, the Development, Manufacture (including formulation) and Commercialization
of all Products unless otherwise provided herein.

3.2 Diligence. During the Term, Sanofi-Aventis shall use Diligent Efforts to
Develop and Commercialize in each of the Major Territories at least [ * ],
provided however that Sanofi-Aventis may satisfy such obligation by sublicensing
the Development and Commercialization of a Product to a Third Party pursuant to
the terms of this Agreement.

3.3 Discussion Opportunity. Exelixis may notify Sanofi-Aventis in writing if
Exelixis in good faith believes that Sanofi-Aventis is not meeting its diligence
obligations set forth in Section 3.2, and the Parties shall meet and discuss the
matter in good faith. Exelixis may further request review of Sanofi-Aventis’
records generated and maintained as required under Section 3.4 below, to the
extent those records relate to Development, Manufacture and Commercialization of
a Product.

3.4 Reports. Beginning on with the first full [ * ] that ends at least [ * ]
after the JRDC and JEC are disbanded pursuant to Section 4.1, and for each [ * ]
thereafter during the Term, Sanofi-Aventis shall submit to Exelixis a written
progress report summarizing the Development, Manufacturing, and
Commercialization of Products performed by Sanofi-Aventis. If [ * ] for Exelixis
to exercise its rights under this Agreement, Exelixis may request that
Sanofi-Aventis provide more detailed information and data regarding such reports
by Sanofi-Aventis, and Sanofi-Aventis shall promptly provide Exelixis with
information and data as is reasonably related to such request, at Exelixis’
expense. All such reports shall be considered Confidential Information of
Sanofi-Aventis.

 

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4. GOVERNANCE

4.1 Collaboration Governance and Committee Structure.

(a) Role of Committees. Subject to Section 4.1(b) and the other terms and
conditions of this Agreement, the Parties shall establish: (i) a joint executive
committee (the “Joint Executive Committee” or “JEC”) that will oversee the
Collaboration and facilitate communications between the Parties with respect to
the discovery and Development of Products hereunder; and (ii) a specialized
joint committee (such committee, the “Joint Research & Development Committee” or
“JRDC”) focusing on each of the following areas arising out of the
Collaboration: (A) discovery and chemical optimization of Collaboration
Compounds up to Development Compound nomination; and (B) Development (including
preclinical development) and Regulatory Approval of Products. Each Committee
shall have the responsibilities and authority allocated to it in this Article 4
and elsewhere in this Agreement. It is contemplated that: (X) all significant
matters relating to the discovery, lead optimization, preclinical and clinical
Development of Products under this Agreement will be addressed by the JRDC and,
if appropriate, by the JEC, as contemplated by Section 4.4(c); and (Y) the
Parties’ respective activities under this Agreement will be reported to the
relevant Committees in a reasonable and appropriate level of detail. The JRDC
shall provide, on a [ * ] basis (unless otherwise requested by the JEC), updates
on its activities and achievements to the JEC for review and comment. The
Parties intend that their respective organizations will work together to assure
the success of the Collaboration.

(b) Limitations on the Authority of Committees. Notwithstanding the Committee
structure established pursuant to Section 4.1(a), each Party shall retain the
rights, powers and discretion granted to it under this Agreement, and no such
rights, powers, or discretion shall be delegated to or vested in a Committee
unless such delegation or vesting of rights is expressly provided for in this
Agreement or the Parties expressly so agree in writing. Without limiting the
generality of the foregoing, no Committee shall have any authority or
jurisdiction to: (i) amend, modify, or waive compliance with this Agreement, any
of which shall require mutual written agreement of the Parties; or (ii) require
Exelixis to [ * ], without the Parties’ prior written agreement.

(c) Discontinuation of Participation on a Committee. Each Committee shall
continue to exist until the first to occur of: (i) the Parties mutually agreeing
to disband the Committee; or (ii) a Party providing to the other Party written
notice of its intention to disband and no longer participate in such Committee.
Once one Party has provided the other Party written notice as referred to in
subclause (ii) above, such Committee shall have no further obligations under
this Agreement and such other Party receiving such notice shall have the right
to solely decide, without consultation, any matters previously before such
Committee, subject to the other terms of this Agreement.

(d) Disbandment of JEC and JRDC. The Parties hereby agree that the JEC and the
JRDC shall be disbanded within [ * ] following the completion of any and all
Development activities to be performed by Exelixis hereunder, including but not
limited to the Exelixis Clinical Trials.

 

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4.2 Joint Executive Committee.

(a) Formation and Purpose. Exelixis and Sanofi-Aventis shall establish the JEC
within [ * ] after the Effective Date. Subject to Sections 4.1(b) and 4.4(c),
the JEC’s responsibilities shall be: (i) to determine the strategy for the
research and Development of Collaboration Compounds and Products; (ii) to
coordinate the Parties’ activities hereunder; and (iii) as applicable, to
review, comment on, approve, and resolve disputes with respect to the foregoing
matters or other matters which the Parties wish to bring to the JEC, including
the specific responsibilities of the JEC outlined below. The JEC shall have the
membership and shall operate by the procedures set forth in Section 4.4.

(b) Specific Responsibilities of the JEC. In addition to its overall
responsibility for the Collaboration, but subject to Sections 4.1(b) and 4.4(c),
the JEC shall, in particular, have the following specific responsibilities:

(i) Review and approve the research and Development strategies for each
Collaboration Compound and Product;

(ii) oversee the Parties’ activities hereunder;

(iii) approve budgets for the Exelixis Development Expenses;

(iv) review all significant and strategic issues within the purview of the JRDC;

(v) oversee the Development of each Product pursuant to its Initial Development
Plan and respective Annual Development Plan, up to the initiation of Phase III
Clinical Trials;

(vi) review and approve any material amendments to the Approved Plans and any
other items submitted to the JEC by the JRDC;

(vii) provide a forum for disputed matters within the responsibilities of JRDC;
and

(viii) such other responsibilities as may be assigned to the JEC pursuant to the
Agreement or as may be agreed between the Parties from time to time.

4.3 Joint Research & Development Committee.

(a) Formation and Purpose. Exelixis and Sanofi-Aventis shall establish the JRDC
within [ * ] after the Effective Date, which Committee shall, subject to
Sections 4.1(b) and 4.4(c), oversee the discovery efforts and preclinical
development of Collaboration Compounds, as described in Article 2. The JRDC
shall have the membership and shall operate by the procedures set forth in
Section 4.3, and shall disband subsequent to the Collaborative Research Term or
otherwise at the direction of the JEC.

 

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(b) Specific Responsibilities of the JRDC. In addition to its overall
responsibility described above, and subject to Sections 4.1(b) and 4.4(c), the
JRDC shall, in particular, have the following specific responsibilities:

(i) provide a forum for the Parties to report progress with respect to discovery
and preclinical development activities and to allow the Parties to review and
comment with respect to such discovery activities;

(ii) determine which: (A) [ * ] will become Pre-Lead Compounds; (B) Pre-Lead
Compounds will become Lead Compounds; and (C) Lead Compounds will be nominated [
* ] as Development Candidates;

(iii) prioritize and allocate Party resources for lead optimization projects as
set forth in the Research Plan;

(iv) review and revise the Research Plan;

(v) determine which Development Candidates will be nominated [ * ] for IND
submission;

(vi) provide [ * ] with its recommendation as to which Party it believes should
be responsible for CMC Activities, preclinical development, IND submission and
conduct of Phase I Clinical Trials for a Collaboration Compound (it being
understood that assignment of the foregoing responsibilities will be made by
Sanofi-Aventis);

(vii) monitor Development activities, including with respect to operational
matters such as enrollment strategies, site selection, CRO contract strategies;

(viii) review and discuss the Initial Development Plan and each Annual
Development Plan;

(ix) review all material information generated in the course of implementing the
Initial Development Plan and the Annual Development Plans;

(x) assist in coordinating scientific interactions and division of
responsibilities with respect to Development activities, and resolving
disagreements during the course of implementing the Initial Development Plan and
the Annual Development Plans;

(xi) provide on a [ * ] basis updates on its activities and achievements to the
JEC for review and comment;

 

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(xii) initiate a transfer of the IND for the Product in an Exelixis Clinical
Trial in advance of [ * ]; and

(xiii) such other responsibilities as may be assigned to the JRDC pursuant to
the Agreement or as may be agreed between the Parties from time to time.

4.4 General Committee Membership and Procedures.

(a) Membership. Each Committee shall be composed of such number of
representatives as may be agreed by the Parties. Each of Sanofi-Aventis and
Exelixis shall designate representatives with appropriate expertise to serve as
members of each Committee. Each Party may replace its Committee representatives
at any time upon written notice to the other Party. Each Committee shall have
co-chairpersons. Sanofi-Aventis and Exelixis shall each select from their
representatives a co-chairperson for each of the Committees, and each Party may
change its designated co-chairpersons from time to time upon written notice to
the other Party. The Alliance Managers shall be responsible for calling
meetings, preparing and circulating an agenda in advance of each meeting of such
Committee, and preparing and issuing minutes of each meeting within [ * ]
thereafter; provided that a Committee co-chairperson shall call a meeting of the
applicable Committee promptly upon the written request of the other
co-chairperson to convene such a meeting. The minutes of each meeting shall,
among other things, record all matters acted upon and approved or disapproved by
the Committee, actions to be taken, and any matters the Committee failed to
resolve. Such minutes will not be finalized until both Alliance Managers review
and confirm in writing the accuracy of such minutes.

(b) Meetings. Each Committee shall hold meetings at such times as it elects to
do so, but in no event shall such meetings be held less frequently than once
every [ * ] for the JRDC, and once every [ * ] for the JEC. Each Committee shall
meet alternately at Exelixis’ facilities in South San Francisco, California, and
Sanofi-Aventis’ facilities in the Paris, France metro area, or at such other
locations as the Parties may agree. The Alliance Managers shall, and other
employees of each Party involved in the discovery, preclinical development,
Development, Manufacture, or Commercialization of any Product may as needed,
attend meetings of each Committee (as nonvoting participants unless they are
members of such Committee), and consultants, representatives or advisors
involved in the discovery, preclinical development, Development or Manufacture
of any Product may attend meetings of each Committee as nonvoting observers;
provided that such employees and Third Party representatives are under
obligations of confidentiality and non-use applicable to the Confidential
Information of each Party that are at least as stringent as those set forth in
Article 11, and in the case of non-employees of a Party, subject to the consent
of the other Party, which shall not be unreasonably withheld or delayed. Each
Party shall be responsible for all of its own expenses of participating in any
Committee (including in any Working Group). Meetings of any Committee may be
held by audio or video teleconference; provided that at least [ * ] per year of
such Committee shall be held in person. No action taken at any meeting of a
Committee shall be effective unless a representative of each Party is
participating.

 

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(c) Decision-Making.

(i) Voting on Committee Decisions. Subject to Section 4.1(b), each Party’s
designees on a Committee shall, collectively, have one (1) vote (the “Party
Vote”) on all matters brought before the Committee, which Party Vote shall be
determined by [ * ] of such Party’s designees present (in person or otherwise)
at the meeting. Except as expressly provided in this Section 4.4(c) and subject
to Section 4.1(b), each Committee shall operate as to matters within its
jurisdiction by unanimous Party Vote. All decisions of a Committee shall be
documented in writing in the minutes of the applicable Committee meeting by the
Alliance Managers.

(ii) [ * ] Decisions. [ * ] shall be made by Sanofi-Aventis; provided, however
that, any [ * ], shall be made by Exelixis. Any dispute regarding a decision
made by [ * ] pursuant to this paragraph shall first be referred to the Alliance
Managers, and, if the dispute is not resolved within [ * ] after such referral
to the Alliance Managers, then it shall, upon written notice by a Party to the
other, be referred to the JRDC and/or JEC for resolution.

(iii) Disagreements on Committees. Except for matters outside the jurisdiction
and authority of the Committees and in any event without limiting the other
rights and obligations of the Parties under this Agreement, any disagreement
between the designees of Sanofi-Aventis and Exelixis on the JRDC as to matters
within such Committee’s jurisdiction shall, at the election of either Party, be
addressed, first, with the Alliance Managers, and, if the dispute is not
resolved within [ * ] after such referral to the Alliance Managers, then it
shall, upon written notice by a Party to the other, be submitted to the JEC for
resolution. If the JEC does not resolve any such matter submitted to it for
resolution within [ * ] after such submission, , then the [ * ] co-chairperson
of the JEC shall have the right to decide any such matter, subject to
Section 4.4(c)(iv).

(iv) [ * ]. [ * ] right to exercise final decision-making authority pursuant to
Section 4.4(c)(iii) ([ * ]) shall be subject to the following limitations:

(1) All [ * ] shall be made in good faith, with due regard for the impact of
such decisions on Products, and, consistent in all material respects with the
applicable Approved Plan and the terms of this Agreement. No such decision by [
* ] shall violate or breach any term or condition of this Agreement. [ * ] shall
make all [ * ] only after [ * ] (through its JEC or JRDC members, as applicable)
on such matters and the [ * ], and in the case of [ * ] made pursuant to Section
[ * ], only after [ * ], and the [ * ] on such matters, at a subsequent meeting.

(2) [ * ] shall have no right to make a [ * ]: (A) on any matter that would
require [ * ]; (B) on any matter that would amend, violate or breach any
provision of this Agreement; (C) to change the [ * ]; (D) to change the [ * ];
(E) [ * ]; or (F) on any matter that would require [ * ]. Resolution of disputes
relating to the foregoing matters shall require mutual agreement of the Parties
(except as otherwise expressly set forth in this Agreement).

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(d) Meeting Agendas and Minutes. Each Party shall disclose to the other proposed
agenda items along with appropriate information at least [ * ] in advance of
each meeting of the applicable Committee; provided that under exigent
circumstances requiring Committee input, a Party may provide its agenda items to
the other Party within a shorter period of time in advance of the meeting.

(e) Working Groups. From time to time, the JEC or JRDC may establish and
delegate duties to other committees, sub-committees or directed teams (each, a
“Working Group”) on an “as-needed” basis to oversee particular projects or
activities, which delegation shall be reflected in the minutes of the meetings
of the applicable Committee. Each such Working Group shall be constituted and
shall operate as the JEC or JRDC, as the case may be, determines. The Working
Groups may be established on an ad hoc basis for purposes of a specific project,
for the life of a Product, or on such other basis as the applicable Committee
may determine. Each Working Group and its activities shall be subject to the
oversight, review and approval of, and shall report to, the Committee that
established such Working Group. In no event shall the authority of the Working
Group exceed that specified for the relevant Committee in this Article 4. Any
disagreement between the designees of Sanofi-Aventis and Exelixis on a Working
Group shall be referred to the applicable Committee for resolution.

(f) Interactions Between Committees and Internal Teams. The Parties recognize
that each Party possesses an internal structure (including various committees,
teams and review boards) that will be involved in administering such Party’s
activities under this Agreement. Each Committee shall establish procedures to
facilitate communications between such Committee or Working Group and the
relevant internal committee, team or board of each of the Parties, including by
requiring appropriate members of such Committee to be available at reasonable
times and places and upon reasonable prior notice for making appropriate oral
reports to, and responding to reasonable inquiries from, the relevant internal
committee, team or board.

4.5 Alliance Managers.

(a) Appointment. Each of the Parties shall appoint a single individual to act as
a single point of contact between the Parties (each, an “Alliance Manager”).
Each Party may change its designated Alliance Manager from time to time upon
written notice to the other Party. Any Alliance Manager may designate a
substitute to temporarily perform the functions of that Alliance Manager by
written notice to the other Party.

(b) Responsibilities. The Alliance Managers shall use good faith efforts to
attend all Committee meetings and support the co-chairpersons of each Committee
in the discharge of their responsibilities. Alliance Managers shall be nonvoting
participants in such Committee meetings, unless they are also appointed members
of such Committee pursuant to Section 4.4(a). An Alliance Manager may bring any
matter to the attention of any Committee if such Alliance Manager reasonably
believes that such matter warrants such attention. Each Alliance Manager shall
be charged with creating and maintaining a collaborative work environment within
and among the Committees. In addition, each Alliance Manager: (i) will be the
point of first referral in all matters of conflict resolution; (ii) will
coordinate the relevant

 

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amended.

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functional representatives of the Parties in developing and executing strategies
and plans for the Products in an effort to ensure consistency and efficiency
throughout the world; (iii) will provide a single point of communication for
seeking consensus both internally within the respective Parties’ organizations
and between the Parties regarding key strategy and plan issues; (iv) will
identify and bring disputes to the attention of the appropriate Committee in a
timely manner; (v) will plan and coordinate cooperative efforts and internal and
external communications; and (vi) will take responsibility for ensuring that
governance activities, such as the conduct of required Committee meetings and
production of meeting minutes, occur as set forth in this Agreement, and that
relevant action items resulting from such meetings are appropriately carried out
or otherwise addressed.

 

5. DEVELOPMENT OF PRODUCTS

5.1 Lead Development Party. The JRDC shall recommend to Sanofi-Aventis the Party
that it believes should serve as the lead Party for the conduct of the first
Phase I Clinical Trial for each Product. The JRDC’s recommendation shall be made
in the best interest of the Collaboration. After careful review of the
recommendation of the JRDC, Sanofi-Aventis shall determine which Party shall
serve as the lead Party for the conduct of the first Phase I Clinical Trial (the
“Lead Development Party”). If Sanofi-Aventis determines that Exelixis serve as
the Lead Development Party for a Product, then Exelixis’ responsibility to
Develop such Product shall cease after the Transfer Date for the first Phase I
Clinical Trial for such Product, and Sanofi-Aventis shall be responsible (as of
the Transfer Date) for all further Development of such Product pursuant in
Section 3.1. If Sanofi-Aventis is the Lead Development Party for a Product, then
Sanofi-Aventis shall be responsible for all Development of such Product pursuant
to Sections 3.1, 5.2 and 5.3.

5.2 Initial Development Plans.

(a) Scope. The initial Development of each Product shall be governed by a
comprehensive, multi-year plan covering the conduct of the early clinical
development of such Product up to clinical proof-of-concept (the “Initial
Development Plan”). The Initial Development Plan shall: (i) provide a
comprehensive Development program that is designed to generate the non-clinical,
clinical and regulatory information required for submitting Drug Approval
Applications and to obtain Regulatory Approvals for the relevant indications;
(iii) indicate [ * ]; (iv) set forth those obligations assigned to each Party
with respect to the performance of the Development activities contemplated by
such Initial Development Plan; (v) contain a study protocol for the
establishment of [ * ] for the Product in the first Phase I Clinical Trial; and
(vi) provide an expected forecast, based on the information available at the
time, including patient estimates and cost forecasts (and methodology, if
available).

 

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(b) Creation of Initial Development Plan. The Lead Development Party shall use
Diligent Efforts to prepare and submit to the JRDC a draft of the Initial
Development Plan for a given Product no later than [ * ] prior to the
anticipated date of IND submission for such Product. The JRDC shall promptly
meet, discuss such draft and provide feedback to the Lead Development Party. The
Lead Development Party shall use Diligent Efforts to prepare a final version of
the Initial Development Plan, including a final study protocol, and submit it to
the JRDC for final review approximately [ * ] in advance of the anticipated IND
submission date. The JRDC shall promptly meet, discuss such final version and
provide feedback to the Lead Development Party. After obtaining any additional
feedback, the Lead Development Party shall prepare and submit the IND package to
the applicable Regulatory Authority pursuant to Section 2.3(f).

(c) Updates to the Initial Development Plan. Any material update, amendment or
modification to any provisions of such Initial Development Plan shall require
the approval of the JEC.

(d) Reports. Beginning [ * ] after disbandment of the JRDC and JEC in accordance
with Section 4.1(d), and every [ * ] thereafter during the Term, Sanofi-Aventis
shall submit to Exelixis a written progress report, substantially in the form of
Exhibit 5.2(d), which summarizes the Development of Products performed by
Sanofi-Aventis.

5.3 Annual Development Plans.

(a) Scope. To further refine each Initial Development Plan, the JRDC shall
prepare a separate, detailed and specific Development plan covering all material
Development activities to be performed for such Product for such year, and
budgets covering all Exelixis Development Expenses for those Development
activities for such Product conducted in support of Regulatory Approvals for
such Product (each, an “Annual Development Plan”). Each Annual Development Plan
and budget shall be proposed by the JRDC for approval by the JEC. Each Annual
Development Plan for such Product, and any modifications thereto, shall cover,
and be consistent in all material respects with, all the Development activities
and budgets in the then-current Initial Development Plan for such Product that
are to be performed in that particular Calendar Year.

(b) Procedure. The initial Annual Development Plan shall be prepared by the Lead
Development Party in conjunction with the preparation of the Initial Development
Plan described in Section 5.2(b). Thereafter, the Lead Development Party shall
submit on an annual basis an Annual Development Plan for each Product to the
JRDC for its review, comment, and approval. Each such submission shall be no
later than [ * ] of the Calendar Year immediately preceding the year covered by
such Annual Development Plan, with a goal of having the Annual Development Plan
approved, and any disputes resolved, by [ * ] of such immediately preceding
Calendar Year.

5.4 Exelixis Clinical Trials.

(a) Scope. Exelixis shall conduct the Exelixis Clinical Trials for each
applicable Product in a collaborative and efficient manner. The Parties shall
engage in joint decision-making for the Exelixis Clinical Trials as set forth in
Article 4.

 

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(b) Notwithstanding anything to the contrary in this Agreement, the Parties
agree that Exelixis shall be the sponsor for, and the Lead Development Party
for, the Exelixis Clinical Trials, and that Exelixis shall have the
responsibility and the authority to act as the sponsor and make those decisions
and take all actions necessary to assure compliance with all regulatory
requirements. Exelixis agrees to be bound by, and perform all obligations set
forth in, 21 C.F.R. §312 related to its role as the sponsor for the Exelixis
Clinical Trials for a given Product. Notwithstanding anything to the contrary in
this Agreement, Exelixis may discontinue or modify any clinical trial that is
part of the Exelixis Clinical Trials without the approval of the JRDC or the JEC
in the event such actions are: (i) [ * ]; and (ii) [ * ], provided however, that
in such an event the JRDC and JEC shall be informed of such discontinuation or
modification without delay. The Annual Development Plan for an Exelixis Clinical
Trial may specify that outside contractors (reporting to, or acting on behalf
of, Exelixis and reasonably selected by Exelixis) will have responsibility to
direct and conduct any additional pre-clinical activities and applicable
clinical trials in any country. The Parties shall, to the extent practicable and
permitted by applicable law, rule or regulation, cooperate, prior to engagement
of a given outside contractor, to minimize costs associated with the retention
of any outside contractors, including, where possible, the retention by Exelixis
of Sanofi-Aventis contractors where cost savings may be achieved by doing so.

(c) Exelixis shall use Diligent Efforts to carry out its responsibilities under
the then-applicable Initial Development Plan and Annual Development Plan.
Exelixis shall have the right to use commercially reasonable discretion in
carrying out its obligations under the Annual Development Plan and the Initial
Development Plan, including without limitation: (i) carrying out day-to-day
planning and implementation of activities under the Annual Development Plan;
(ii) managing day-to-day regulatory compliance matters, including adverse event
reporting; (iii) managing clinical research organizations engaged to carry out
activities under the Annual Development Plan; and (iv) managing the Exelixis
Clinical Trials.

5.5 Exelixis Development Expenses.

(a) Process for Payments of Exelixis Development Expenses. Promptly after the
date of the JRDC meeting allocating to Exelixis the performance of a Phase I
Clinical Trial, Exelixis shall provide Sanofi-Aventis with an estimate of the
Exelixis Development Expenses (and invoice for Exelixis FTE Costs and for
Out-of-Pocket Costs incurred by Exelixis, accompanied by reasonable supporting
documentation, given that such invoicing will be on an accrual basis) covering:
(i) the period between the aforementioned JRDC meeting and the start of the
first Calendar Quarter arising after the date of such JRDC meeting; and (ii) the
first Calendar Quarter arising after the date of such JRDC meeting. By the [ * ]
of each subsequent Calendar Quarter during the Term, Exelixis shall provide
Sanofi-Aventis with: (A) an estimate of the Exelixis Development Expenses for
such Calendar Quarter (and invoice for Exelixis FTE Costs); and (B) with the
actual Exelixis Development Expenses for the preceding Calendar Quarter (and
invoice for Out-of-Pocket Costs incurred by Exelixis during that Calendar
Quarter, accompanied by reasonable supporting documentation, given that such
invoicing will be on an accrual basis). Any overpayment or underpayment of the
actual Exelixis FTE Costs against the prepayment made for the preceding Calendar
Quarter will be netted by Exelixis against the current Calendar Quarter estimate
therefor. Sanofi-Aventis shall pay Exelixis the amount in each such invoice
within [ * ] after receipt thereof. Sanofi-Aventis shall have the right, at a
reasonable time and upon reasonable prior notice [ * ], to audit Exelixis’
records as provided in Section 13.3(c) to confirm the accuracy of Exelixis’
costs and reports with respect to Exelixis Development Expenses under this
Agreement.

 

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(b) Accounting of Exelixis Development Expenses. Exelixis agrees to determine
Exelixis Development Expenses using its standard accounting procedures,
consistently applied, [ * ] as specifically provided in this Agreement. The
Parties also recognize that such procedures may change from time to time. The
Parties agree that, where such changes are economically material to either
Party, and consistent with GAAP, adjustments shall be made to compensate the
affected Party to preserve the same economics as reflected under this Agreement
under Exelixis’ accounting procedures in effect as of the date on which the
activity in question (e.g., Development) first commences under this Agreement. [
* ]. Transfers between a Party and its Affiliates (or between its Affiliates)
shall not have effect for purposes of calculating revenues, costs, profits,
royalties or other payments or expenses under this Agreement.

(c) [ * ]

(d) FTE Records and Calculations; Adjustments to Exelixis FTE Rate. Exelixis
shall record and account for its FTE effort for the Development of Products to
the extent that such FTE efforts are included in Exelixis Development Expenses,
and shall report such FTE effort to the JRDC on a quarterly basis. The Exelixis
FTE Rate may be adjusted annually, with each annual adjustment effective as of
January 1 of each Calendar Year, in accordance with the percentage increase or
decrease, if any, in the US CPI for the twelve (12) months ending June 30 of the
Calendar Year prior to the Calendar Year for which the adjustment is being made.

5.6 Technology and Regulatory Transfer of Collaboration Compounds. Exelixis
shall disclose or transfer to Sanofi-Aventis the Information and documents
described in subsections 5.6(a) and 5.6(b) below:

(a) Within [ * ] after the Transfer Date, Exelixis shall, at Sanofi-Aventis’
expense, disclose (and provide copies, as applicable) to Sanofi-Aventis any
Information, including any preclinical data, clinical data, assays, protocols,
procedures and any other information in Exelixis’ possession or control, not
previously disclosed to Sanofi-Aventis, and [ * ] to continue clinical
Development of such Product, or in seeking Regulatory Approval of such Products.

(b) The Parties shall cooperate to ensure that Exelixis transfers to
Sanofi-Aventis, [ * ] after the Transfer Date for a given Product: (i) [ * ];
(ii) any agreements [ * ], all agreements [ * ]. If an agreement that is
described in subsection [ * ] is not assignable, then Exelixis shall use
Diligent Efforts to amend the agreement to permit assignment.

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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6. REGULATORY

6.1 Regulatory Responsibility.

(a) Subject to Section 3.2 and Section 6.1(b), Sanofi-Aventis shall, during the
Term, have [ * ] discretion, control and responsibility for the preparation,
drafting, submission and filing, in its own name and at its own cost, of all
DAAs, documents, dossiers, etc., for Regulatory Approvals for the Products.
Subject to Section 6.1(b), Sanofi-Aventis shall have [ * ] responsibility for
interacting with any Regulatory Authority regarding any issues, DAAs or any
Regulatory Approval, and Exelixis shall provide its reasonable assistance to
Sanofi-Aventis (at Sanofi-Aventis’ expense), whenever Sanofi-Aventis seeks such
assistance, to answer questions on the Products from any Regulatory Authority.
Additionally, in the event Sanofi-Aventis must communicate with or respond to a
Regulatory Authority within a very limited amount of time and needs the
assistance of Exelixis for such interaction with the Regulatory Authority,
Exelixis will use its Diligent Efforts to assist Sanofi-Aventis within the
required time frame (at Sanofi-Aventis’ expense). Furthermore, subject to
Section 6.1(b) and to applicable laws and regulations, Sanofi-Aventis shall own
all Regulatory Approvals, submissions and dossiers that it files as well as the
Regulatory Approvals that are granted during the Term, including supporting
documentation and information.

(b) Pending the [ * ], Exelixis shall remain the primary contact of Regulatory
Authorities for regulatory activities regarding such Product, on behalf of
Sanofi-Aventis. However, Sanofi-Aventis shall have the right to review and
approve in advance any communication with any Regulatory Authority regarding
such Product. Upon the [ * ], Exelixis shall notify the applicable Regulatory
Authorities in writing that it is [ * ] for the applicable Product to
Sanofi-Aventis, and Sanofi-Aventis would notify the applicable Regulatory
Authorities in writing that it is [ * ] and all responsibilities associated
therewith (including without limitation, the responsibility for reporting
adverse events), other than any ongoing activities of Exelixis relating to
ongoing Exelixis Clinical Trials (if applicable).

6.2 Other Regulatory Matters.

(a) Pharmacovigilance. Sanofi-Aventis shall be responsible for the management of
all pharmacovigilance and all reports required by the Regulatory Authorities in
order to obtain and maintain any Regulatory Approvals granted for the Products
in the Territory, including, without limitation, adverse drug experience
reports. The Parties agree to negotiate and execute a definitive safety data
exchange agreement (the “SDEA”) within [ * ] of the Effective Date of this
Agreement, or within another time period as mutually agreed by the Parties,
which will describe the responsibilities and procedures to be followed by the
Parties with regard to all regulatory reporting for the Products under this
Agreement.

(b) Pricing and Reimbursement Approvals. Sanofi-Aventis and its Affiliates shall
have sole responsibility in the conduct of all pricing and reimbursement
approval proceedings relating to each Product.

 

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(c) Rights of Reference. Each Party shall have the right to cross reference,
file or incorporate by reference any regulatory filing or drug master file (as
defined in the Code of Federal Regulations) (and any data contained therein) for
any Product (including all Approvals) in order to support regulatory filings
that such Party is permitted to make under this Agreement for any such Product
and to enable such Party to fulfill its obligations under this Agreement to
Develop, Manufacture (anywhere in the world), or Commercialize any such Product.

6.3 Packaging and Promotional Materials.

(a) Subject to Section 6.3(b) through 6.3(d), Sanofi-Aventis shall be solely
responsible for creating all packaging and promotional materials for the
Products. Sanofi-Aventis shall own all right, title and interest in and to any
and all such promotional materials, including all applicable copyrights,
trademarks, program names and domain names.

(b) During the Term, Sanofi-Aventis shall ensure that the packaging artwork and
label and the marketing materials, used for Commercializing each Product in the
U.S., Japan, and the Major European Countries, clearly identify Exelixis as the
licensor of the Product, provided however that any such references comply with
applicable laws and market practice in such countries. For the purpose of the
foregoing, Exelixis grants Sanofi-Aventis the right to use certain of Exelixis
corporate trademarks in accordance with the Trademark License Agreement attached
as Exhibit 6.3.

(c) Sanofi-Aventis shall provide to Exelixis, the mock-ups for any packaging
artwork and labels or marketing material it wishes to use for the
Commercialization of a Product.

(d) In the event Exelixis shall desire to make any change to any printing,
packaging or labeling proposed or used for a Product to reflect any changes to
its trademark, tradename, logo or other features thereof (other than a change to
correct an error or omission in such trademark, tradename, logo or other
features), Exelixis shall be responsible for, and shall reimburse Sanofi-Aventis
for, all costs associated with such changes, if any, including the costs of any
inventory of the Product or labeling, printing or packaging materials rendered
obsolete or rejected as a result of such change, including the cost of
destruction of any of the foregoing.

6.4 Recalls. Any decision to initiate a recall or withdrawal of a Product shall
be made by Sanofi-Aventis. In the event of any recall or withdrawal,
Sanofi-Aventis shall take any and all necessary action to implement such recall
or withdrawal in accordance with applicable law, with assistance from Exelixis
as reasonably requested by Sanofi-Aventis. The costs of any such recall or
withdrawal shall be borne solely by Sanofi-Aventis, [ * ].

 

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7. MANUFACTURING

7.1 Manufacturing Generally.

(a) Subject to the terms and conditions of this Agreement, Sanofi-Aventis shall
at all time Control the Manufacturing process development and may elect to
Manufacture a Lead Compound, Development Candidate or a Product at any time
during the Term. Any and all technology and Information relating to and required
for the Manufacturing of a Lead Compound, a Development Candidate or a Product
(including, as the case may be, any related Third Party agreements) (the
“Manufacturing Technology”) [ * ] during the Term of this Agreement, shall be
transferred and assigned to Sanofi-Aventis and disclosed pursuant to
Section 7.3, within a reasonable period following Exelixis’ receipt of
notification in writing by Sanofi-Aventis of its election to take over the
Manufacturing of such Lead Compound, Development Candidate or Product.

(b) Notwithstanding the foregoing, the Party designated by the JRDC pursuant to
Section 7.2(a) to perform process development and Manufacturing activities
shall, retain responsibility for the Manufacture and supply of part or all of
the Clinical Supply Requirements necessary for the Development of a Development
Candidate or a Product in accordance with Section 7.2(c).

7.2 Manufacturing Activities.

(a) Discovery and Characterization of Lead Compounds. During the Collaborative
Research Term, the JRDC shall prioritize advanced Lead Compounds for scale-up
manufacturing to allow expanded profiling in efficacy, PK and toxicology assays.
The JRDC shall also determine which Party shall conduct (or have conducted) the
following activities, [ * ]:

(i) Evaluation of the medicinal chemistry synthetic route for such Lead Compound
to determine if it can be safely and reproducibly scaled up. If such route
cannot be safely scaled up, then evaluate alternate routes. Preparation for this
activity may occur before the Development Candidate declaration.

(ii) [ * ].

(iii) Preformulation characterization.

(iv) Manufacture of approximately [ * ] of such Lead Compound required for full
characterization.

The Party designated by the JRDC shall use Diligent Efforts to perform (or have
performed) the activities described in subsections (i) – (iv) at is own expense.

(b) CMC Activities for Development Candidates. After Sanofi-Aventis determines
to advance a Lead Compound as a Development Candidate, the Party that was
allocated the Manufacturing responsibilities for such Development Candidate
shall use Diligent Efforts during the Collaborative Research Term to conduct the
following activities on such Development Candidate to support its IND submission
and early clinical development (the “CMC Activities”):

(i) Conduct analytical methods development and qualification (e.g., stability
indicating HPLC, process specific OVI’s by GC, etc.).

 

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(ii) Preparation of drug substance for IND-enabling non-clinical safety studies
(“NCSS”).

(iii) Conduct stability studies (ICH) on the NCSS batch.

(iv) Perform the tech transfer of process and analytical methods to internal
production group or contract manufacturing organization for preparation of GMP
drug substance.

(v) Identify a suitable formulation for the GLP NCSS.

(vi) Develop a simple formulation for rapid entry into Phase I Clinical Trials.

(vii) Prepare a prototype formulation for comparative pK study (intended
clinical formulation vs. NCSS tox formulation).

(viii) Conduct stability studies on formulation prototypes (ICH).

(ix) Conduct further analytical methods development and qualification (e.g.,
potency, purity, dissolution, content uniformity, etc.).

(x) Perform the tech transfer of drug product process and analytical methods to
contract manufacturing organization for preparation of GMP clinical supplies.

(c) Clinical Supply.

(i) Any costs and expenses incurred by either Party in carrying out the
Manufacturing of Clinical Supply Requirements for the first Phase I Clinical
Trial of any Product shall be borne solely by Sanofi-Aventis, including expenses
for Exelixis’ transfer to Sanofi-Aventis of any Product (or related active
pharmaceutical ingredients) that may exist prior to the Transfer Date and that
was Manufactured for use in the Development of such Product.

(ii) Prior to the transfer and assignment under Section 7.3 of any Manufacturing
Technology for a Product [ * ], Exelixis shall Manufacture, or arrange with a
Third Party for the Manufacture of Clinical Supply Requirements with respect to
such Product. After the completion of Exelixis’ transfer under Section 7.3 of
the Manufacturing Technology for a given Product, Sanofi-Aventis may, at its
discretion, Manufacture, or arrange with Third Parties for the Manufacture of
any Clinical Supply Requirements (in bulk and finished form). Alternatively,
Sanofi-Aventis may require that Exelixis continues to supply such Clinical
Supply Requirements for a period to be agreed between the Parties or as may be
imposed by regulatory requirements.

 

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(iii) Promptly after the Effective Date, the Parties shall enter into a letter
agreement, substantially in the form of the letter described in Exhibit 7.2,
containing the terms and conditions for the quality responsibilities associated
with Exelixis’ provision of Clinical Supply Requirements for the Development of
the Products.

(d) Commercial Supply. Sanofi-Aventis shall Manufacture, or arrange with Third
Parties for the Manufacture of Product(s) (in bulk and finished form) for use in
Commercialization.

7.3 Transfer of Manufacturing Technology.

(a) [ * ] after the Transfer Date for a given Product, Exelixis shall disclose
(and provide copies, as applicable) to either Sanofi-Aventis or a Third Party
manufacturer designated by Sanofi-Aventis [ * ] that is Controlled by Exelixis,
required for the Manufacture of such Product and is [ * ] to enable
Sanofi-Aventis or such Third Party manufacturer (as appropriate) to Manufacture
such Product, including the Information described on Exhibit 7.3(a). The steps,
planning and obligations of the Parties regarding the transfer of the
Manufacturing Technology for such Product (for both the active pharmaceutical
ingredient and the drug product as the case may be) will be set forth in a
“Technology Transfer Master Plan API” and a “Technology Transfer Master Plan
Drug Product” respectively, to be executed between the Parties.

(b) Upon request, Exelixis will [ * ] use Diligent Efforts to provide
Sanofi-Aventis with any additional information or on-site support as may be
required by Sanofi-Aventis and its Affiliates in connection with the transfer of
the Manufacturing Technology. Sanofi-Aventis shall reimburse Exelixis for any
on-site support rendered at the Exelixis FTE Rate per FTE-day of 8 hours,
provided further Exelixis shall in no event be obliged to provide more than [ *
] FTE-days of 8 hours in total, unless the Parties otherwise agree in writing.

(c) At any time during the transfer of the Manufacturing Technology,
Sanofi-Aventis may require to perform a technical audit of Exelixis’ or any
Third Party’s facilities where the Products and their respective active
pharmaceutical ingredient are Manufactured. During such audit, Sanofi Aventis
shall have the right to review the batch records and any other relevant
documentation related to the Manufacture of the Product, and Exelixis shall use
its Diligent Efforts to facilitate such review. Should Exelixis’ agreement with
the applicable Third Party vendor not permit or contemplate the possibility of
such an audit, [ * ].

(d) For the purpose of this Section 7.4, the actual transfer to Sanofi-Aventis
of the Manufacturing Technology with respect to a particular Product shall be
deemed completed when [ * ].

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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8. LICENSES AND RELATED RIGHTS

8.1 Licenses to Sanofi-Aventis; Exelixis’ Retained Rights; and Co-Branding.

(a) Collaborative Research. During the Collaborative Research Term, and subject
to the terms and conditions of this Agreement, Exelixis hereby grants
Sanofi-Aventis an exclusive, worldwide, royalty-free license (without the right
to sublicense except to Third Party contract research providers and
manufacturers), under the Exelixis Patents, Exelixis Know-How and Exelixis’
interest in the Joint Invention Patents, solely to: (i) conduct Sanofi-Aventis’
responsibilities under the Research Plan; and (ii) conduct Manufacturing
activities pursuant to Section 7.2(a) or Section 7.2(b), as applicable.

(b) Development and Commercialization. During the Term, and subject to the terms
of this Agreement, Exelixis hereby grants Sanofi-Aventis an exclusive,
worldwide, royalty-bearing license (with the right to sublicense), under the
Exelixis Patents, Exelixis Know-How and Exelixis’ interest in the Joint
Invention Patents to: (i) develop, make, have made, or use any Development
Candidate; and (ii) develop, make, have made, use, import, sell, offer to sell,
have sold, or otherwise commercialize Products.

(c) Exelixis Retained Rights. Exelixis retains all rights to use the Exelixis
Know-How, Exelixis Patents and Joint Invention Patents, except those expressly
granted to Sanofi-Aventis on an exclusive basis under the terms of this
Agreement. Notwithstanding the exclusive licenses granted to Sanofi-Aventis
pursuant to Sections 8.1(a) and 8.1(b), Exelixis retains the right to practice
the Exelixis Patents, the Exelixis Know-How and the Joint Invention Patents to:
(i) make, have made, use, and test Collaboration Compounds solely for internal
research purposes; and (ii) perform (and to sublicense (or otherwise enter into
contractual arrangements with) Third Parties to perform) Exelixis’ obligations
under this Agreement, including the conduct of any Exelixis Clinical Trials and
any related Manufacture of Products under Article 7.

8.2 Sanofi-Aventis License Limitations and Covenants.

(a) Sanofi-Aventis hereby covenants that Sanofi-Aventis shall not (and shall
ensure that any of its permitted sublicensees shall not) use any Exelixis
Know-How, Exelixis Patents or any chemical or biological materials that may be
transferred to it by Exelixis under this Agreement during the Collaborative
Research Term, in each case for a purpose other than that expressly permitted in
Sections 8.1(a) and (b) above.

(b) Sanofi-Aventis acknowledges and agrees that: (i) the licenses granted in
Section 8.1(a) shall not create (by any means, whether expressly, impliedly or
by estoppel) any right or license under any Patents, Information or other
intellectual property right that is Controlled by Exelixis to research, develop,
manufacture and/or commercialize any compound that is not a Collaboration
Compound, and/or any composition containing any of the foregoing; and (ii) the
license granted in Section 8.1(b) shall not create (by any means, whether
expressly, impliedly or by estoppel) any right or license under any Patents,
Information or other intellectual property right that is Controlled by Exelixis
to develop, manufacture and/or commercialize any compound that is not a
Development Candidate, and/or any composition containing any of the foregoing.
For clarity, the licenses in Sections 8.1(a) and (b) do not grant Sanofi-Aventis
any right to research, develop, make, have made, use, import, sell, offer to
sell, have sold and otherwise commercialize any compounds that selectively
inhibit PI3Kd or PI3Kg

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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8.3 Limited License to Exelixis for Collaborative Research and Development.
During the Term, and subject to the terms and conditions of this Agreement,
Sanofi-Aventis hereby grants Exelixis a non-exclusive, worldwide, royalty-free
license (without the right to sublicense except to Third Party contract research
providers and manufacturers), under the Sanofi-Aventis Patents, Sanofi-Aventis
Know-How and Sanofi-Aventis’ interest in the Joint Invention Patents, to perform
(and to sublicense (or otherwise enter into contractual arrangements with) Third
Parties to perform) Exelixis’ obligations under this Agreement, including the
conduct of any of Exelixis’ responsibilities under the Research Plan, the
conduct of the Exelixis Clinical Trials and any related Manufacture of Products
under Article 7.

8.4 Exelixis License Limitations and Covenants.

(a) Exelixis hereby covenants that Exelixis shall not (and shall ensure that any
of its permitted sublicensees shall not) use any Sanofi-Aventis Know-How,
Sanofi-Aventis Patents or any chemical or biological materials that may be
transferred to it by Sanofi-Aventis under this Agreement during the
Collaborative Research Term, in each case for a purpose other than that
expressly permitted in Sections 8.3 and 12.3.

(b) Each sublicense granted by Exelixis, pursuant to Section 8.3, to a Party who
is an Affiliate at the time such license is granted shall terminate immediately
upon such Party ceasing to be an Affiliate.

8.5 No Additional Licenses. Except as expressly provided in Sections 8.1, 8.3,
and 12.3, nothing shall grant either Party any right, title or interest in and
to the intellectual property rights of the other Party (either expressly or by
implication or estoppel).

8.6 Sublicensing. Each Party shall provide the other Party with the name of each
permitted sublicensee of its rights under this Article 8 and a copy of the
applicable sublicense agreement; provided that each Party may redact
confidential or proprietary terms from such copy, including financial terms. The
sublicensing Party shall remain responsible for each permitted sublicensee’s
compliance with the applicable terms and conditions of this Agreement.

8.7 Exclusivity.

(a) General Rule. Subject to Sections 8.7(b) (c) and (d), during the period
beginning on the Effective Date and ending [ * ], neither Party shall (directly
or indirectly, and either with or without a bona fide collaborator) [ * ].

(b) Exception for [ * ]. Notwithstanding anything to the contrary, if a Party is
engaged in the [ * ]: (i) for which [ * ]; and (ii) that is [ * ], and [ * ],
then [ * ].

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(c) Exception for [ * ]. Notwithstanding anything to the contrary, the
restrictions in Section 8.7(a) shall not apply to any [ * ]: (i) that [ * ]; and
(ii) for which [ * ]; and (iii) for which [ * ].

(d) Sanofi-Aventis [ * ]. Following the termination of the Agreement pursuant to
Section 12.2(a), Exelixis shall have the right but not the obligation to conduct
any programs that are intended to [ * ], provided, however, that in the event
Exelixis wishes to [ * ] and [ * ]. If the Parties do not [ * ].

 

9. COMPENSATION

9.1 Fees.

(a) Upfront Fee. Sanofi-Aventis shall pay Exelixis an upfront fee of Twenty
Million Dollars ($20,000,000) within [ * ] after the Effective Date. The upfront
fee payment made by Sanofi-Aventis to Exelixis pursuant to this Section 9.1(a)
shall be noncreditable and nonrefundable.

(b) Annual Research Fee. Sanofi-Aventis shall pay Exelixis a guaranteed annual
research fee of Seven Million Dollars ($7,000,000) during the Collaborative
Research Term in [ * ]. The [ * ] shall be due on the [ * ] of the Effective
Date, and each of the remaining [ * ]. Payments of [ * ] in subsequent years
will be due on the [ * ]. The guaranteed annual research fee payments made by
Sanofi-Aventis to Exelixis pursuant to this Section 9.1(b) shall be
noncreditable and nonrefundable.

(c) Success Fees. Sanofi-Aventis shall pay Exelixis success fees of:

(i) [ * ] within [ * ] after [ * ]; and

(ii) [ * ] within [ * ] after [ * ].

The success fee payments made by Sanofi-Aventis to Exelixis pursuant to this
Section 9.1(c) shall be noncreditable and nonrefundable. Notwithstanding [ * ],
the fees payable pursuant to: (X) Section 9.1(c)(i) shall in no event be greater
than [ * ] in the aggregate; and (Y) Section 9.1(c)(ii) shall in no event be
greater than [ * ] in the aggregate.

9.2 Milestone Payments. The milestone payments under both subsections (a) and
(b) of this Section 9.2 shall be applicable and payable for each Product. All
milestone payments made by Sanofi-Aventis to Exelixis hereunder shall be
noncreditable and nonrefundable.

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(a) Development and Regulatory Milestones. Sanofi-Aventis shall make the
milestone payments set forth below to Exelixis within [ * ] after the
achievement of each of the following events for each Product by Sanofi-Aventis
or any of its Affiliates or sublicensees:

 

Event

  

Milestone Payment

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

[ * ]

   [ * ]

An Indication that is relevant for the achievement of a given clinical trial or
approval event in Section 9.2(a) does not have to be the same Indication that is
relevant for the achievement of a different clinical trial or approval event in
Section 9.2(a). For example, [ * ].

(b) Commercial Milestones. Sanofi-Aventis shall make the milestone payments set
forth below to Exelixis after the achievement of each of the following events by
Sanofi-Aventis or any of its Affiliates or sublicensees for each Product. Each
milestone payment shall be made by Sanofi-Aventis within [ * ] after the end of
the year in which such milestone event is met:

(i) [ * ] upon the first time the annual, worldwide, aggregate, Net Sales of the
Product reach or exceed [ * ];

(ii) [ * ] upon the first time the annual, worldwide, aggregate, Net Sales of
the Product reach or exceed [ * ]; and

(iii) [ * ] upon the first time the annual, worldwide, aggregate, Net Sales of
the Product reach or exceed [ * ].

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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9.3 Royalty Payments.

(a) Royalty Rates. Sanofi-Aventis shall pay Exelixis royalties, on a
country-by-country basis, on Net Sales of each Product at the royalty rates
stated below.

(i) If [ * ], then the royalty rates are:

(1) [ * ] of the annual, worldwide, aggregate Net Sales less than [ * ] by
Sanofi-Aventis (or its Affiliate or sublicensee) of such Product;

(2) [ * ] of the annual, worldwide, aggregate Net Sales equal to or greater than
[ * ] and less than [ * ] by Sanofi-Aventis (or its Affiliate or sublicensee) of
such Product;

(3) [ * ] of the annual, worldwide, aggregate Net Sales equal to or greater than
[ * ] by Sanofi-Aventis (or its Affiliate or sublicensee) of such Product.

(4) By way of example, if, during any Calendar Year, the amount of Net Sales of
a Product is [ * ], Exelixis will receive [ * ].

(ii) If [ * ], then the royalty rates are:

(1) [ * ] of the annual, worldwide, aggregate Net Sales less than [ * ] by
Sanofi-Aventis (or its Affiliate or sublicensee) of such Product;

(2) [ * ] of the annual, worldwide, aggregate Net Sales equal to or greater than
[ * ] and less than [ * ] by Sanofi-Aventis (or its Affiliate or sublicensee) of
such Product;

(3) [ * ] of the annual, worldwide, aggregate Net Sales equal to or greater than
[ * ] by Sanofi-Aventis (or its Affiliate or sublicensee) of such Product.

(iii) By way of example, if, during any Calendar Year, the amount of Net Sales
of a Product is [ * ], Exelixis will receive [ * ].

(b) Royalty Adjustments.

(i) Third Party Royalty Offset. Subject to Section 9.3(b)(iii) below,
Sanofi-Aventis may deduct from the royalties it would otherwise owe in a
particular country for a particular Product pursuant to Section 9.3(a), an
amount equal to [ * ] of royalties paid by Sanofi-Aventis to Third Parties with
respect to licenses to [ * ].

(ii) Reduced Royalties. Subject to Section 9.3(b)(iii) below, Sanofi-Aventis’
royalty obligations under Section 9.3(a) above with respect to a particular
Product in a particular country shall be reduced by [ * ]: (A) in the event the
Product is [ * ]; or (B) after expiration in such country of [ * ].

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(iii) Minimum Royalty Rate. During the Royalty Term the operation of [ * ],
singularly or in combination, shall not reduce the royalties due to Exelixis for
any Product below [ * ] of what would otherwise have been due under
Section 9.3(a).

(iv) [ * ]. During the applicable Royalty Term, for a particular Product and in
a particular country, if [ * ], and [ * ], then [ * ] for as long as [ * ] or [
* ]. During the applicable Royalty Term, for a particular Product and in a
particular country, if [ * ], and [ * ], then [ * ] for as long as [ * ] or [ *
].

9.4 Quarterly Payments. All royalties due under Section 9.3 shall be paid
quarterly, on a country-by-country basis, within [ * ] of the end of the
relevant quarter for which royalties are due.

9.5 Term of Royalties. Exelixis’ right to receive royalties for a particular
Product under Section 9.3 shall expire on a country-by-country basis upon the
later of: (a) [ * ]; or (b) [ * ] (the “Royalty Term”).

9.6 Royalty Payment Reports. Each royalty payment shall be accompanied by a
statement stating the number, description, and aggregate Net Sales, by country,
of each Product sold during the relevant Calendar Quarter.

9.7 Payment Method. All payments due under this Agreement to Exelixis shall be
made by bank wire transfer in immediately available funds to an account
designated by Exelixis. All payments hereunder shall be made in Dollars. For
milestone payments due under Section 9.2(a), Sanofi-Aventis shall notify
Exelixis in writing within [ * ] of the achievement of each event that triggers
a milestone payment, and, within [ * ] of receipt of such notice, Exelixis shall
provide Sanofi-Aventis with an invoice for each such milestone payment.

9.8 Taxes. Exelixis shall pay any and all taxes levied on account of all
payments it receives under this Agreement. If laws or regulations require that
taxes be withheld, Sanofi-Aventis shall: (a) deduct those taxes from the
remittable payment; (b) pay the taxes to the proper taxing authority; and
(c) send evidence of the obligation together with proof of tax payment to
Exelixis within [ * ] following that tax payment.

9.9 Blocked Currency. In each country where the local currency is blocked and
cannot be removed from the country, royalties accrued in that country shall be
paid to Exelixis in the country in local currency by deposit in a local bank
designated by Exelixis, unless the Parties otherwise agree.

9.10 Sublicenses. In the event Sanofi-Aventis grants licenses or sublicenses to
others to sell Products which are subject to royalties under Section 9.3, such
licenses or sublicenses shall include an obligation for the licensee or
sublicensee to account for and report its sales of Products on the same basis as
if such sales were Net Sales by Sanofi-Aventis, and Sanofi-Aventis shall pay, or
shall ensure that sublicensee shall pay, to Exelixis, with respect to such
sales, royalties as if such sales of the licensee or sublicensee were Net Sales
of Sanofi-Aventis.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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9.11 Foreign Exchange. Conversion of sales recorded in local currencies to U.S.
dollars shall be performed in a manner consistent with Sanofi-Aventis’ normal
practices used to prepare its audited financial statements for internal and
external reporting purposes, which uses a widely accepted source of published
exchange rates.

9.12 Records; Inspection. Sanofi-Aventis shall keep complete, true and accurate
books of account and records for the purpose of determining the payments to be
made under this Agreement. Such books and records shall be kept for at least [ *
] following the end of the Calendar Quarter to which they pertain. Such records
shall be open for inspection during such [ * ] period by independent
accountants, solely for the purpose of verifying payment statements hereunder.
Such inspections shall be made no more than [ * ], at reasonable time and on
reasonable notice. Any unpaid amounts (plus interest) that are discovered shall
be paid promptly by Sanofi-Aventis. Inspections conducted under this
Section 9.12 shall be at the expense of Exelixis, unless a variation or error
producing an increase exceeding [ * ] of the royalty amount stated for any
period covered by the inspection is established in the course of such
inspection, whereupon all costs relating to the inspection for such period shall
be paid promptly by Sanofi-Aventis.

9.13 Interest. If Sanofi-Aventis fails to make any payment due to Exelixis under
this Agreement, then interest shall accrue on a daily basis at the greater of a
rate equal to [ * ] commercial lending rate of CitiBank, N.A. San Francisco,
California, or at the maximum rate permitted by applicable law, whichever is the
lower.

 

10. INTELLECTUAL PROPERTY

10.1 Ownership.

(a) Inventorship; Joint Research Agreement. The inventorship of all Sole
Inventions and Joint Inventions shall be determined under the patent laws of the
United States. The Parties acknowledge and agree that this Agreement shall be
deemed to be a Joint Research Agreement under 35 U.S.C. 103(c).

(b) Sole Invention Patents. Subject to Section 10.1(c), each Party shall own the
entire right, title and interest in and to any and all of its Sole Inventions
Patents.

(c) Contractual Joint Patents. Notwithstanding the provision of Section 10.1(b),
the Parties agree that the Parties shall be joint owners in and to all
Contractual Joint Patents. Accordingly, each Party hereby transfers and assigns
an undivided half (1/2) interest in the Contractual Joint Patents to the other
Party.

(d) Joint Invention Patents. Sanofi-Aventis and Exelixis shall be joint owners
in and to all Joint Inventions. Sanofi-Aventis and Exelixis as joint owners each
shall have the right to [ * ].

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(e) Obligations to Assign. All employees, agents and contractors of each Party
shall be under written obligation to assign any inventions and related
intellectual property to the Party for whom they are employed or are providing
services.

10.2 Disclosure. Each Party shall disclose in writing to the JEC any Sole
Invention or Joint Invention arising hereunder which it believes may be
patentable, within [ * ] following the day such Invention was made or at such
earlier time as may be necessary to preserve patentability of such Invention.
Each Party shall provide to the other Party such assistance and execute such
documents as are reasonably necessary to permit the filing and prosecution of
any Patent to be filed on such Sole Invention or Joint Invention, or the
issuance, maintenance or extension thereof.

10.3 Patent Prosecution and Maintenance; Abandonment.

(a) Filing, Prosecution and Maintenance of Exelixis Prosecuted Patents.

(i) Exelixis’ Right to File, Prosecute and Maintain Sanofi-Aventis Patents.
Subject to the rest of this Section 10.3(a), Exelixis shall be responsible for
the preparation, filing, prosecution (including any interferences, reissue
proceedings and reexaminations) and maintenance of (A) [ * ] (the “Exelixis
Prosecuted Patents”), provided that such responsibilities shall be carried out
by [ * ], or by [ * ]. Exelixis, [ * ] shall provide Sanofi-Aventis with an
update of the filing, prosecution and maintenance status for each of the
Exelixis Prosecuted Patents on a periodic basis, and shall use Diligent Efforts
to consult with and cooperate with Sanofi-Aventis with respect to the filing,
prosecution and maintenance of the Exelixis Prosecuted Patents, including
providing Sanofi-Aventis with drafts of proposed filings to allow Sanofi-Aventis
a reasonable opportunity for review and comment before such filings are due.
Exelixis, [ * ] shall provide to Sanofi-Aventis copies of any papers relating to
the filing, prosecution and maintenance of the Exelixis Prosecuted Patents
promptly upon their being filed and received.

(ii) Abandonment. In no event shall Exelixis knowingly permit any of the
Exelixis Prosecuted Patents to be abandoned in any country, or elect not to file
a new patent application claiming priority to a patent application within the
Exelixis Prosecuted Patents either before such patent application’s issuance or
within the time period required for the filing of an international (i.e., Patent
Cooperation Treaty), regional (including European Patent Office) or national
application, without Sanofi-Aventis’ written consent (such consent to not be
unreasonably withheld, delayed or conditioned) or Sanofi-Aventis otherwise first
being given an opportunity to assume full responsibility ([ * ] at
Sanofi-Aventis’ expense) for the continued prosecution and maintenance of such
Exelixis Prosecuted Patents or the filing of such new patent application. In the
event that Exelixis decides either: (A) not to continue the prosecution or
maintenance of a Patent within the Exelixis Prosecuted Patents in any country;
or (B) not to file such new patent application, Exelixis shall provide
Sanofi-Aventis with written notice of this decision at least [ * ] prior to any
pending lapse or abandonment thereof. In the event that Sanofi-Aventis decides
to assume responsibility for such filing, prosecution and maintenance,
Sanofi-Aventis shall so notify Exelixis in writing and Exelixis shall (i) [ * ],
and (ii) cooperate as

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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reasonably requested by Sanofi-Aventis to facilitate such [ * ] transfer of
filing, prosecution and maintenance responsibility to Sanofi-Aventis. [ * ]. In
the case where Sanofi-Aventis takes over the filing, prosecution or maintenance
of any Patent as set forth above, Exelixis shall not be liable to Sanofi-Aventis
in any way with respect to the results obtained from, the filing, prosecution,
issuance, extension or maintenance of any such Patent or any failure by
Sanofi-Aventis to so file, prosecute, extend or maintain, provided however that
Exelixis shall, at the expense of Sanofi-Aventis, provide such assistance and
execute such documents as are reasonably necessary to continue or permit the
filing, prosecution or maintenance of such Patent or the issuance, maintenance
or extension of any resulting Patent or permit enforcement of Patents.

(b) Filing, Prosecution and Maintenance of Sanofi-Aventis Prosecuted Patents.

(i) Sanofi-Aventis’ Right to File, Prosecute and Maintain Exelixis Patents.
Subject to the rest of this Section 10.3(b), Sanofi-Aventis shall be responsible
for the filing, prosecution (including any interferences, reissue proceedings
and reexaminations) and maintenance of (A) [ * ] (the “Sanofi-Aventis Prosecuted
Patents”). Sanofi-Aventis, [ * ] shall provide Exelixis with an update of the
filing, prosecution and maintenance status for each of the Sanofi-Aventis
Prosecuted Patents on a periodic basis, and shall use Diligent Efforts to
consult with and cooperate with Exelixis with respect to the filing, prosecution
and maintenance of the Sanofi-Aventis Prosecuted Patents, including providing
Exelixis with drafts of proposed filings to allow Exelixis a reasonable
opportunity for review and comment before such filings are due. Sanofi-Aventis,
[ * ] shall provide to Exelixis copies of any papers relating to the filing,
prosecution and maintenance of the Sanofi-Aventis Prosecuted Patents promptly
upon their being filed and received.

(ii) Abandonment. In no event shall Sanofi-Aventis knowingly permit any of the
Sanofi-Aventis Prosecuted Patents to be abandoned in any country, or elect not
to file a new patent application claiming priority to a patent application
within the Sanofi-Aventis Prosecuted Patents either before such patent
application’s issuance or within the time period required for the filing of an
international (i.e., Patent Cooperation Treaty), regional (including European
Patent Office) or national application, without Exelixis’ written consent (such
consent to not be unreasonably withheld, delayed or conditioned) or Exelixis
otherwise first being given an opportunity to assume full responsibility ([ * ]
at Exelixis’ expense) for the continued prosecution and maintenance of such
Sanofi-Aventis Prosecuted Patents or the filing of such new patent application.
In the event that Sanofi-Aventis decides either: (A) not to continue the
prosecution or maintenance of a Patent within the Sanofi-Aventis Prosecuted
Patents in any country; or (B) not to file such new patent application,
Sanofi-Aventis shall provide Exelixis with written notice of this decision at
least [ * ] prior to any pending lapse or abandonment thereof. In the event that
Exelixis decides to assume responsibility for such filing, prosecution and
maintenance, Exelixis shall so notify Sanofi-Aventis in writing and
Sanofi-Aventis shall (i) [ * ], and (ii) cooperate as reasonably requested by
Exelixis to facilitate such [ * ] transfer of filing, prosecution and
maintenance responsibility to Exelixis. [ * ]. In the case where Exelixis takes
over the filing, prosecution or maintenance of any Patent as set forth above,
Sanofi-Aventis shall not be liable to Exelixis in any way with respect to the
results obtained from, the filing,

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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prosecution, issuance, extension or maintenance of any such Patent or any
failure by Exelixis to so file, prosecute, extend or maintain, provided however
that Sanofi-Aventis shall, at the expense of Exelixis, provide such assistance
and execute such documents as are reasonably necessary to continue or permit the
filing, prosecution or maintenance of such Patent or the issuance, maintenance
or extension of any resulting Patent or permit enforcement of Patents.

(c) Patent Term Extension. Exelixis and Sanofi-Aventis shall each cooperate with
each another and shall use Diligent Efforts in obtaining patent term extension
(including any pediatric exclusivity extensions as may be available) or
supplemental protection certificates or their equivalents in any country with
respect to patent rights covering the Products. [ * ], then, if reasonably
requested [ * ], [ * ]. Exelixis [ * ] apply for patent term extensions or
supplemental protection certificates or their equivalents in any country under
the [ * ] during the Term. If elections with respect to obtaining such patent
term extensions or supplemental protection certificates or their equivalents in
any country are to be made, [ * ] shall have the right to make the election to
seek patent term extension or supplemental protection or their equivalents in
any country, provided that such election shall be made so as to [ * ].

(d) Patent Expenses.

(i) [ * ] costs and expenses (including fees for any outside counsel, and inside
counsel fees) associated with the filing, prosecution (including any
interferences, reissue proceedings and reexaminations) and maintenance of [ * ].

(ii) [ * ] costs and expenses (including fees for any outside counsel, and
inside counsel fees) associated with the filing, prosecution (including any
interferences, reissue proceedings and reexaminations) and maintenance of [ * ].

(e) Patent Report. Each Party shall provide to the other Party, on a [ * ]
basis, a patent report that includes the serial number, docket number and status
of each Patent for which, pursuant to this Section 10.3, such Party has the
right to direct the filing, prosecution and maintenance and which covers a Sole
Invention or Joint Invention.

10.4 Enforcement of Patent Rights. If either Party becomes aware of a suspected
infringement of any Exelixis Patents, Sanofi-Aventis Patents, or Joint Invention
Patents by a Third Party, such Party shall notify the other Party promptly, and
following such notification, the Parties shall confer. [ * ] shall have the
first right, but shall not be obligated, to bring an infringement action against
such Third Party at its own expense and by counsel of its own choice, and [ * ]
shall have the right to participate in such action, at its own expense and by
counsel of its own choice. If [ * ] fails to bring such an action or proceeding
prior to the earlier of: (a) [ * ] following [ * ] receipt of notice of alleged
infringement; or (b) [ * ] before the time limit, if any, set forth in the
appropriate laws and regulations for the filing of such actions, [ * ] shall
have the right to bring and control any such action, at its own expense and by
counsel of its own choice, and [ * ] shall have the right to be represented in
any such action, at its own expense and by counsel of its own choice. If a Party
brings an infringement action pursuant to this Section 10.4, the other Party
will reasonably assist the enforcing Party (at the enforcing Party’s

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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expense) in such actions or proceedings if so requested, and will lend its name
to such actions or proceedings if required by law in order for the enforcing
Party to bring such action. Neither Party, and no Third Party having a license
under any Exelixis Patent or Joint Invention Patent shall have the right to
settle any patent infringement litigation under this Section 10.4 in a manner
that diminishes the rights or interests of the other Party without the prior
written consent of such other Party, such consent not to be unreasonably
withheld or delayed. Except as otherwise agreed to by the Parties as part of a
cost sharing arrangement, any recovery realized as a result of such litigation,
after reimbursement of any litigation expenses of Sanofi-Aventis and Exelixis,
shall be [ * ], except that [ * ].

(a) Data Exclusivity and Orange Book Listings. With respect to data exclusivity
periods (such as those periods listed in the FDA’s Orange Book (including any
available pediatric extensions) or periods under national implementations of
Article 10.1(a)(iii) of Directive 2001/EC/83, and all international
equivalents), Sanofi-Aventis shall use commercially reasonable efforts
consistent with its obligations under applicable law (including any applicable
consent order) to seek maintain and enforce all such data exclusivity periods
available for the Products. With respect to filings in the FDA Orange Book (and
foreign equivalents) for issued patents for a Product, upon request by
Sanofi-Aventis (and at Sanofi-Aventis’ expense), Exelixis shall provide
reasonable cooperation to Sanofi-Aventis in filing and maintaining such Orange
Book (and foreign equivalent) listings.

(b) No Action in Violation of Law. Neither Party shall be required to take any
action pursuant to this Section 10.4 that such Party reasonably determines in
its sole judgment and discretion conflicts with or violates any court or
government order or decree applicable to such Party.

(c) Notification of Patent Certification. Exelixis shall notify and provide
Sanofi-Aventis with copies of any allegations of alleged patent invalidity,
unenforceability or non-infringement of an Exelixis Patent licensed hereunder
pursuant to a Paragraph IV Patent Certification by a third Party filing an
Abbreviated New Drug Application, an application under §505(b)(2) or other
similar patent certification by a Third Party, and any foreign equivalent
thereof. Such notification and copies shall be provided to Sanofi-Aventis by
Exelixis as soon as practicable and at least within [ * ] after Exelixis
receives such certification, and shall be sent by facsimile and overnight
courier to the address set forth in Section 15.7 below.

10.5 Defense of Third Party Claims. [ * ]. If a claim is brought by a Third
Party that [ * ], each Party shall give prompt written notice to the other Party
of such claim, and following such notification, the Parties shall confer on how
to respond. Notwithstanding anything contained herein to the contrary, each
Party shall [ * ].

10.6 Copyright Registrations. Copyrights and copyright registrations on
copyrightable subject matter shall be filed, prosecuted, defended, and
maintained, and the Parties shall have the right to pursue infringers of any
copyrights owned or Controlled by it, in substantially the same manner as the
Parties have allocated such responsibilities, and the expenses therefor, for
patent rights under this Article 10.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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11. CONFIDENTIALITY

11.1 Nondisclosure of Confidential Information. All Information disclosed by one
Party to the other Party pursuant to this Agreement, including disclosure by
either Party to the other of any results and data resulting from its activities
hereunder shall be “Confidential Information” for all purposes hereunder. The
Parties agree that during the Term and for a period of [ * ] thereafter, a Party
receiving Confidential Information of the other Party shall: (a) use Diligent
Efforts to maintain in confidence such Confidential Information (but not less
than those efforts as such Party uses to maintain in confidence its own
proprietary industrial information of similar kind and value) and not to
disclose such Confidential Information to any Third Party without prior written
consent of the other Party (such consent to not be unreasonably withheld,
delayed or conditioned), except for disclosures made in confidence to any Third
Party under terms consistent with this Agreement and made in furtherance of this
Agreement or of rights granted to a Party hereunder; and (b) not use such other
Party’s Confidential Information for any purpose except those permitted by this
Agreement or in connection with exercising such Party’s rights and/or fulfilling
its obligations under this Agreement (it being understood that this Section 11.1
shall not create or imply any rights or licenses not expressly granted under
Article 8 or Section 12.3 hereof). Notwithstanding anything to the contrary in
this Section 11.1, data or other information resulting from the research
conducted by each Party pursuant to the Collaboration shall be Confidential
Information of both Parties, whether disclosed by Exelixis or Sanofi-Aventis.

11.2 Exceptions. The obligations in Section 11.1 shall not apply with respect to
any portion of the Confidential Information that the receiving Party can show by
competent written proof:

(a) Subject to the last sentence in Section 11.1, is publicly disclosed by the
disclosing Party, either before or after it is disclosed to the receiving Party
hereunder; or

(b) Was known to the receiving Party or any of its Affiliates, without
obligation to keep it confidential, prior to disclosure by the disclosing Party;
or

(c) Is subsequently disclosed to the receiving Party or any of its Affiliates by
a Third Party lawfully in possession thereof and without obligation to keep it
confidential; or

(d) Is published by a Third Party or otherwise becomes publicly available or
enters the public domain, either before or after it is disclosed to the
receiving Party, and is not directly or indirectly supplied by the receiving
Party in violation of this Agreement; or

(e) Has been independently developed by employees or contractors of the
receiving Party or any of its Affiliates without the aid, application or use of
the disclosing Party’s Confidential Information.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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11.3 Authorized Disclosure. A Party may disclose the Confidential Information
belonging to the other Party to the extent such disclosure is reasonably
necessary in the following instances; provided that notice of any such
disclosure shall be provided as soon as practicable to the other Party:

(a) Filing or prosecuting Patents relating to Sole Inventions, Joint Inventions
or Products, in each case pursuant to activities under this Agreement, provided
that the non-filing Party is given a reasonable opportunity to review the extent
and necessity for its Confidential Information to be included prior to
submission of any patent application;

(b) Regulatory filings;

(c) Prosecuting or defending litigation;

(d) Complying with applicable governmental laws and regulations; and

(e) Disclosure, in connection with the performance of this Agreement, to
Affiliates, potential collaborators, partners, and licensees (including
potential co-marketing and co-promotion contractors), research collaborators,
potential investment bankers, investors, lenders, and investors, employees,
consultants, or agents, each of whom prior to disclosure must be bound by
similar obligations of confidentiality and non-use at least equivalent in scope
to those set forth in this Article 11.

The Parties acknowledge that the terms of this Agreement shall be treated as
Confidential Information of both Parties. Such terms may be disclosed by a Party
to individuals or entities covered by 8.3(e) above, each of whom prior to
disclosure must be bound by similar obligations of confidentiality and non-use
at least equivalent in scope to those set forth in this Article 11. In addition,
a copy of this Agreement may be filed by either Party with the Securities and
Exchange Commission in connection with any public offering of such Party’s
securities. In connection with any such filing, such Party shall endeavor to
obtain confidential treatment of economic and trade secret information.

In any event, the Parties agree to take all reasonable action to avoid
disclosure of Confidential Information except as permitted hereunder.

11.4 Publicity. The Parties agree that the public announcement of the execution
of this Agreement shall be substantially in the form of the press releases
attached as Exhibit 11.4. Any other publication, news release or other public
announcement relating to this Agreement or to the performance hereunder, shall
first be reviewed and approved by both Parties; provided, however, that any
disclosure which is required by law, including disclosures required by the U.S.
Securities and Exchange Commission or made pursuant to the requirements of the
national securities exchange or other stock market on which such Party’s
securities are traded, as advised by the disclosing Party’s counsel may be made
without the prior consent of the other Party, although the other Party shall be
given prompt notice of any such legally required disclosure and to the extent
practicable shall provide the other Party an opportunity to comment on the
proposed disclosure.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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11.5 Publications. Neither Party shall publish or present any proposed
disclosure which relates to any Inventions, or which otherwise may contain
Confidential Information of the other Party, without the opportunity for prior
review by the other Party. Subject to Section 11.3, each Party agrees to provide
the other Party the opportunity to review any proposed disclosure which would or
may constitute an oral, written or electronic public disclosure if made
(including the full content of proposed abstracts, manuscripts or presentations)
which relate to any Collaboration Compound (including a presentation or
publication about the outcome of any Exelixis Clinical Trial), or which
otherwise may contain Confidential Information, at least [ * ] prior to its
intended submission for publication and agrees, upon request, not to submit any
such abstract or manuscript for publication until the other Party is given a
reasonable period of time to secure patent protection for any material in such
publication which it believes to be patentable. Both Parties understand that a
reasonable commercial strategy may require delay of publication of information
or filing of patent applications. The Parties agree to review and consider delay
of publication and filing of patent applications under certain circumstances.
The JEC shall review such requests and recommend subsequent action. Neither
Party shall have the right to publish or present Confidential Information of the
other Party which is subject to Section 11.1. Nothing contained in this
Section 11.5 shall prohibit the inclusion of Confidential Information of the
non-filing Party necessary for a patent application, provided the non-filing
Party is given a reasonable opportunity to review the extent and necessity for
its Confidential Information to be included prior to submission of such patent
application. Any disputes between the Parties regarding delaying a publication
or presentation to permit the filing of a patent application shall be referred
to the JEC.

 

12. TERM AND TERMINATION

12.1 Term. This Agreement shall become effective on the Effective Date and shall
remain in effect until the expiration of the last payment obligation with
respect to any Product, as provided in Article 9 (the “Term”), unless earlier
terminated in accordance with Section 12.2 or by mutual written agreement. Upon
expiration of the Term of this Agreement (but not a termination pursuant to
Section 12.2), [ * ].

12.2 Early Termination.

(a) Termination at End of Collaborative Research Term. If Sanofi-Aventis has not
[ * ] by the last day of the Collaborative Research Term, then this Agreement
shall automatically terminate as of the last day of the Collaborative Research
Term.

(b) Termination by Sanofi-Aventis. Beginning [ * ], Sanofi-Aventis shall have
the right to terminate this Agreement without cause, in whole or on a
Product-by-Product basis, upon [ * ] prior written notice, at the end of which
the termination shall be effective.

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(c) Termination by Exelixis. Exelixis may terminate this Agreement in its
entirety upon [ * ] advance written notice if Sanofi-Aventis or its Affiliates
or sublicensees (directly or indirectly, individually or in association with any
other person or entity) challenge the validity, enforceability or scope of any
Exelixis Patents anywhere in the world. For clarity, any dispute as to whether a
given Patent is within the scope of Exelixis Patents, such matter shall be
subject to dispute resolution as set forth in Section 15.3.

(d) Termination for Material Breach. This Agreement may be terminated by written
notice by either Party at any time during the Term of this Agreement for the
uncured material breach by the other Party of such other Party’s
representations, warranties, covenants or obligations under this Agreement. The
breaching Party shall be given [ * ] from the date of the notice by the
non-breaching Party to cure its material breach, and, if it does not do so, this
Agreement shall be terminated at the end of the [ * ] cure period; provided,
however, if the cause of the material breach is non-payment of the amounts due
under this Agreement, then the cure period for such non-payment shall be [ * ]
from the date of notice of material breach by the non-breaching Party, unless
there exists a bona fide dispute as to whether such payment is due to the
non-breaching Party, in which case, the [ * ] cure period shall be extended
pending resolution of such dispute.

12.3 Survival; Effect of Termination.

(a) Survival. In the event of termination of this Agreement for any reason, the
following provisions of this Agreement shall survive: [ * ].

(b) General Effects. In any event, termination of this Agreement shall not
relieve the Parties of any liability which accrued hereunder prior to the
effective date of such termination nor preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement nor prejudice either Party’s right to obtain
performance of any obligation.

(c) Effects of Termination under Section 12.2(a). In the event of termination of
this Agreement pursuant to Section 12.2(a), all licenses granted by one Party to
the other Party under this Agreement shall immediately terminate, and each
Party’s rights to [ * ] shall [ * ].

(d) Effects of Termination under Sections 12.2(b), Section 12.2(c), or by
Exelixis for Sanofi-Aventis’ breach under Section 12.2(d). In the event of
termination of this Agreement pursuant to Section 12.2(b), Section 12.2(c) or by
Exelixis for Sanofi-Aventis’ breach under Section 12.2(d):

(i) Sanofi-Aventis hereby grants Exelixis a worldwide, exclusive license (with
the right to sublicense) under the Sanofi-Aventis Know-How, Sanofi-Aventis
Patents and Sanofi-Aventis interest in the Joint Invention Patents to develop,
make, have made, use, import, sell, offer to sell and have sold any terminated
Collaboration Compound and products comprising or incorporating one or more of
such Collaboration Compounds (the “Reverted Products”), effective upon such
termination of this Agreement.

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(ii) In consideration for the foregoing license, Exelixis shall pay to
Sanofi-Aventis the following (as applicable).

(1) If Exelixis terminates under Section 12.2(c) or 12.2(d), then Exelixis shall
pay Sanofi-Aventis [ * ].

(2) If there is a termination under Section 12.2(b), and, [ * ], [ * ], then
Exelixis shall pay Sanofi-Aventis [ * ]. For clarity, [ * ].

(3) If there is a termination under Section 12.2(b), and, [ * ], then Exelixis
shall pay Sanofi-Aventis either: (A) [ * ] sell Reverted Products containing a
Collaboration Compound that either: (I) [ * ]; or (II) [ * ]; (B) [ * ] sell
Reverted Products containing a Collaboration Compound that either: (III) [ * ];
or (IV) [ * ]; or (C) [ * ] sell both: (X) [ * ]; and (Y) [ * ]. For clarity, [
* ].

(iii) Sanofi-Aventis shall to transfer via assignment, license or sublicense to
Exelixis: (A) all Sanofi-Aventis Know-How [ * ] for the development, manufacture
and commercialization of any Reverted Product; (B) all regulatory filings
(including any Regulatory Approvals, drug dossiers, and drug master files) in
Sanofi-Aventis’ name; (C) agreements with Third Parties (at Exelixis’ sole
discretion and to the extent that such agreement is assignable or
sublicensable); (D) trademark rights Controlled by Sanofi-Aventis; and
(E) supplies of Product (including any intermediates, retained samples and
reference standards), that in each case ((A) through (E)) are existing and in
Sanofi-Aventis’ Control and that relate to such Reverted Products. Any such
transfer(s) shall be at the sole expense of Exelixis. Sanofi-Aventis shall use
commercially reasonable efforts to maintain ([ * ]) and not to breach any
agreements with Third Parties that provide a grant from such Third Party to
Sanofi-Aventis of rights that are Controlled by Sanofi-Aventis and that are
licensed to Exelixis pursuant to Section 12.3(d)(i). If an agreement that is
described in subsection (iii)(C) is not assignable or not sublicensable, then
Sanofi-Aventis shall use Diligent Efforts to amend the agreement to permit
assignment or sublicensing.

(iv) At Exelixis’ written request, Sanofi-Aventis shall supply, or cause to be
supplied, to Exelixis sufficient quantities of Reverted Product to satisfy
Exelixis’ requirements for Reverted Product for a period of up to [ * ]
following the effective date of termination, as Exelixis may require until
Exelixis can itself assume or transition to a Third Party such manufacturing
responsibilities; provided, however that Exelixis shall use Diligent Efforts to
affect such assumption (or transition) as promptly as practicable. Such supply
shall be at a price equal to [ * ]. Any such supply will be made pursuant to a
supply agreement between the Parties with typical provisions relating to
quality, forecasting and ordering to forecast, force majeure and product
liability and indemnity.

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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(e) Effects of Termination by Sanofi-Aventis for Exelixis’ breach under
Section 12.2(d). In the event of termination of this Agreement by Sanofi-Aventis
for Exelixis’ breach under Section 12.2(d), all licenses granted under this
Agreement shall [ * ]; provided, however, that [ * ].

 

13. REPRESENTATIONS AND WARRANTIES AND COVENANTS

13.1 Mutual Authority. Exelixis and Sanofi-Aventis each represents and warrants
to the other as of the Effective Date that: (a) it has the authority and right
to enter into and perform this Agreement; (b) this Agreement is a legal and
valid obligation binding upon it and is enforceable in accordance with its
terms, subject to applicable limitations on such enforcement based on bankruptcy
laws and other debtors’ rights; and (c) its execution, delivery and performance
of this Agreement shall not conflict in any material fashion with the terms of
any other agreement or instrument to which it is or becomes a Party or by which
it is or becomes bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.

13.2 Rights in Technology.

(a) During the Term, each Party shall use commercially reasonable efforts to
maintain ([ * ]) and not to breach any agreements with Third Parties that
provide a grant of rights from such Third Party to a Party that are Controlled
by such Party and are licensed or become subject to a license from such Party to
the other Party under Article 8. Each Party agrees to provide promptly the other
Party with notice of any such alleged breach or obligation to renew. As of the
Effective Date, each Party is in compliance in all material respects with any
aforementioned agreements with Third Parties.

(b) Each Party represents and warrants that it: (i) has the ability to grant the
licenses contained in or required by this Agreement; and (ii) is not currently
subject to any agreement with any Third Party or to any outstanding order,
judgment or decree of any court or administrative agency that restricts it in
any way from granting to the other Party such licenses or the right to exercise
its rights hereunder.

(c) Each Party represents and warrants that: (i) it has not granted, and
covenants that it shall not grant after the Effective Date and during the Term,
any right, license or interest in or to, or an option to acquire any of the
foregoing with respect to, the intellectual property rights licensed to the
other Party hereunder (including the Exelixis Patents and the Sanofi-Aventis
Patents, as the case may be) that is in conflict with the licenses granted to
the other Party under this Agreement; and (ii) it has not granted any lien,
security interest or other encumbrance (excluding any licenses) with respect to
any of the intellectual property rights licensed to the other Party hereunder
that would prevent it from performing its obligations under this Agreement, or
permitted such a lien, security interest or other encumbrance (excluding any
permitted licenses) to attach to the intellectual property rights licensed to
the other Party hereunder.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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13.3 Covenants of Each Party.

(a) Compliance with Law. Each Party hereby covenants and agrees to comply with
applicable law, rule and regulation in performing its activities under the
Agreement.

(b) Performance by Affiliates. The Parties recognize that each may perform some
or all of its obligations under this Agreement through Affiliates; provided,
however, that each Party shall remain responsible and be guarantor of the
performance by its Affiliates and shall cause its Affiliates to comply with the
provisions of this Agreement in connection with such performance. In particular,
if any Affiliate of a Party participates under this Agreement with respect to
Collaboration Compounds: (a) the restrictions of this Agreement which apply to
the activities of a Party with respect to Collaboration Compounds shall apply
equally to the activities of such Affiliate; and (b) the Party affiliated with
such Affiliate shall assure, and hereby guarantees, that any intellectual
property developed by such Affiliate shall be governed by the provisions of this
Agreement (and subject to the licenses set forth in Article 8 and Section 12.3)
as if such intellectual property had been developed by the Party.

(c) Records. Each Party shall maintain complete and accurate records of all work
conducted and all results, data and developments made pursuant to its activities
hereunder. Such records shall be complete and accurate and shall fully and
properly reflect all work done and results achieved in the performance hereof in
sufficient detail and in good scientific manner appropriate for patent and
regulatory purposes. Each Party shall maintain such records for a period of [ *
] after such records are created; provided that the following records may be
maintained for a longer period, in accordance with each Party’s internal
policies on record retention: (a) scientific notebooks; and (b) any other
records that the other Party reasonably requests be retained in order to ensure
the preservation, prosecution, maintenance or enforcement of intellectual
property rights. Either Party shall have the right to review and copy such
records of the other Party at reasonable times to the extent necessary or useful
for it to conduct its obligations or enforce its rights under this Agreement;
provided, however, that no Party shall have the right to audit the other Party
more than [ * ].

(d) Third Party Agreements. During the Term, each Party shall use Diligent
Efforts to maintain and not to breach any agreements with Third Parties that
provide a grant of rights from such Third Party to a Party that are Controlled
by such Party and are licensed or become subject to a license from such Party to
the other Party under Article 8 or Section 12.3. Each Party agrees to provide
promptly the other Party with notice of any such alleged breach or obligation to
renew. As of the Effective Date, each Party is in compliance in all material
respects with any aforementioned agreements with Third Parties.

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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13.4 Disclaimer. EXCEPT AS PROVIDED IN ARTICLE 13 ABOVE, EACH PARTY EXPRESSLY
DISCLAIMS ANY AND ALL OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED,
INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, AND NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES WITH RESPECT TO ANY RESEARCH RESULTS, COLLABORATION COMPOUNDS, DATA, OR
INVENTIONS (AND ANY PATENT RIGHTS OBTAINED THEREON) IDENTIFIED, MADE OR
GENERATED BY EXELIXIS HEREUNDER OR OTHERWISE MADE AVAILABLE TO THE OTHER PARTY
PURSUANT TO THE TERMS OF THE AGREEMENT.

 

14. INDEMNIFICATION AND LIMITATION OF LIABILITY

14.1 Indemnification by Sanofi-Aventis. Subject to Section 14.3, Sanofi-Aventis
hereby agrees to indemnify, defend and hold harmless Exelixis and its directors,
employees and agents from and against any and all Third Party suits, claims,
actions, demands, liabilities, expenses and/or losses, including reasonable
legal expenses and reasonable attorneys’ fees (collectively, “Losses”) to the
extent such Losses result from the Manufacture, use, handling, storage, sale or
other disposition of Collaboration Compounds or Products by Sanofi-Aventis or
its Affiliates, agents or sublicensees, except to the extent such Losses result
from any: (a) breach by Exelixis of any of its representations and warranties or
covenants under the Agreement; (b) breach of the Agreement or applicable law by
Exelixis; or (c) negligence or willful misconduct by Exelixis, its Affiliates or
(sub)licensees, or their respective directors, employees and agents in the
performance of the Agreement.

14.2 Indemnification by Exelixis. Subject to Section 14.3, Exelixis hereby
agrees to indemnify, defend and hold harmless Sanofi-Aventis and its directors,
employees and agents from and against any and all Losses to the extent such
Losses result from the Manufacture, use, handling, storage, sale or other
disposition of any Collaboration Compound, Product, or Reverted Product by
Exelixis or its Affiliates, agents or sublicensees, except to the extent such
Losses result from any: (a) breach by Sanofi-Aventis of any of its
representations and warranties or covenants under the Agreement; (b) breach of
the Agreement or applicable law by Sanofi-Aventis; or (c) negligence or willful
misconduct by Sanofi-Aventis, its Affiliates or (sub)licensees, or their
respective directors, employees and agents in the performance of the Agreement.

14.3 Conditions to Indemnification. As used herein, “Indemnitee” shall mean a
Party entitled to indemnification under the terms of Section 14.1 or 14.2. A
condition precedent to each Indemnitee’s right to seek indemnification under
such Section 14.1 or 14.2 is that such Indemnitee shall:

(a) inform the indemnifying Party under such applicable Section of a Loss as
soon as reasonably practicable after it receives notice of the Loss;

(b) if the indemnifying Party acknowledges that such Loss falls within the scope
of its indemnification obligations hereunder, permit the indemnifying Party to
assume direction and control of the defense, litigation, settlement, appeal or
other disposition of the Loss (including the right to settle the claim solely
for monetary consideration); provided, that the

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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indemnifying Party shall seek the prior written consent (such consent to not be
unreasonably withheld, delayed or conditioned) of any such Indemnitee as to any
settlement which would materially diminish or materially adversely affect the
scope, exclusivity or duration of any Patents licensed under this Agreement,
would require any payment by such Indemnitee, would require an admission of
legal wrongdoing in any way on the part of an Indemnitee, or would effect an
amendment of this Agreement; and

(c) fully cooperate (including providing access to and copies of pertinent
records and making available for testimony relevant individuals subject to its
control) as reasonably requested by, and at the expense of, the indemnifying
Party in the defense of the Loss.

Provided that an Indemnitee has complied with all of the conditions described in
subsections (a) – (c), as applicable, the indemnifying Party shall provide
attorneys reasonably acceptable to the Indemnitee to defend against any such
Loss. Subject to the foregoing, an Indemnitee may participate in any proceedings
involving such Loss using attorneys of the Indemnitee’s choice and at the
Indemnitee’s expense. In no event may an Indemnitee settle or compromise any
Loss for which the Indemnitee intends to seek indemnification from the
indemnifying Party hereunder without the prior written consent of the
indemnifying Party (such consent to not be unreasonably withheld, delayed or
conditioned), or the indemnification provided under such Section 14.1 or 14.2 as
to such Loss shall be null and void.

14.4 Limitation of Liability. EXCEPT FOR AMOUNTS PAYABLE TO THIRD PARTIES BY A
PARTY FOR WHICH IT SEEKS REIMBURSEMENT OR INDEMNIFICATION PROTECTION FROM THE
OTHER PARTY PURSUANT TO SECTIONS 14.1 AND 14.2, AND EXCEPT FOR BREACH OF SECTION
8.7 OR ARTICLE 11 HEREOF, IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS,
OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY
INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES,
WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT
LIABILITY OR OTHER TORT, OR OTHERWISE, ARISING OUT OF THE AGREEMENT.

 

15. MISCELLANEOUS

15.1 Dispute Resolution.

(a) In the event of any dispute, controversy or claim arising out of, relating
to or in connection with any provision of the Agreement, other than a dispute
between members of a Committee regarding matters under such Committee’s
authority (which shall be handled in accordance with Section 4.4(c)) or a
dispute described in Section 15.3, the Parties shall try to settle their
differences amicably between themselves first, by referring the disputed matter
to the CEO of Exelixis (or his designee) and the CEO of Sanofi-Aventis (or his
designee). Either Party

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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may initiate such informal dispute resolution by sending written notice of the
dispute to the other Party, and, within [ * ] after such notice, such CEOs (or
their respective designees) of the Parties shall meet for attempted resolution
by good faith negotiations. If such CEOs (or their respective designees) are
unable to resolve such dispute within [ * ] of their first meeting for such
negotiations, either Party may seek to have such dispute resolved by arbitration
in accordance with Section 15.1(b) below.

(b) Except as otherwise expressly provided in this Agreement, any unresolved
disputes between the Parties relating to, arising out of or in any way connected
with this Agreement or any term or condition hereof, or the performance by
either Party of its obligations hereunder, whether before or after termination
of this Agreement, shall be submitted to the exclusive jurisdiction of the state
and federal courts sitting in New York, New York.

15.2 Governing Law. Resolution of all disputes, controversies or claims arising
out of, relating to or in connection with the Agreement or the performance,
enforcement, breach or termination of the Agreement and any remedies relating
thereto, shall be governed by and construed under the substantive laws of the
State of New York, without regard to conflicts of law rules.

15.3 Patents and Trademarks; Equitable Relief.

(a) Any dispute, controversy or claim arising out of, relating to or in
connection with: (i) the scope, validity, enforceability or infringement of any
Patent rights covering the manufacture, use or sale of any Product; or (ii) any
trademark rights related to any Product, in each case shall not be resolved
through the procedure described in Section 15.1 but shall be submitted to a
court of competent jurisdiction in the territory in which such Patent or
trademark rights were granted or arose.

(b) Any dispute, controversy or claim arising out of, relating to or in
connection with the need to seek preliminary or injunctive measures or other
equitable relief (e.g., in the event of a potential or actual breach of the
confidentiality and non-use provisions in Article 11) shall not be resolved
through the procedure described in Section 15.1 but shall be immediately brought
in a court of competent jurisdiction.

15.4 Entire Agreement; Amendments. This Agreement sets forth the complete, final
and exclusive agreement and all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties with respect
to the subject matter of this Agreement and supersedes and terminates all prior
agreements and understandings between the Parties with respect to such subject
matter. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties with respect to such subject matter other than as are set forth in
this Agreement. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties unless reduced to writing and signed
by an authorized officer of each Party.

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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15.5 Bankruptcy.

(a) All rights and licenses granted under or pursuant to this Agreement,
including amendments hereto, by Exelixis to Sanofi-Aventis are, for all purposes
of Section 365(n) of Title 11 of the U.S. Code (“Title 11”), licenses of rights
to intellectual property as defined in Title 11. Exelixis agrees during the Term
to create and maintain current copies or, if not amenable to copying, detailed
descriptions or other appropriate embodiments, to the extent feasible, of all
such intellectual property. If a case is commenced by or against Exelixis (the
“Bankrupt Party”) under Title 11, then, unless and until this Agreement is
rejected as provided in Title 11, Exelixis (in any capacity, including
debtor-in-possession) and its successors and assigns (including a Title 11
Trustee) shall, at the election of Exelixis made within sixty (60) days after
the commencement of the case (or, if no such election is made, immediately upon
the request of Sanofi-Aventis) either (i) perform all of the obligations
provided in this Agreement to be performed by Exelixis including, where
applicable, providing to Sanofi-Aventis portions of such intellectual property
(including embodiments thereof) held by Exelixis and such successors and assigns
or otherwise available to them or (ii) provide to Sanofi-Aventis all such
intellectual property (including all embodiments thereof) held by Exelixis and
such successors and assigns or otherwise available to them.

(b) If a Title 11 case is commenced by or against Exelixis and this Agreement is
rejected as provided in Title 11 and Sanofi-Aventis elects to retain its rights
hereunder as provided in Title 11, then Exelixis (in any capacity, including
debtor-in-possession) and its successors and assigns (including a Title 11
Trustee) shall provide to Sanofi-Aventis all such intellectual property
(including all embodiments thereof) held by Exelixis and such successors and
assigns or otherwise available to them immediately upon Sanofi-Aventis’s written
request therefor. Whenever Exelixis or any of its successors or assigns provides
to Sanofi-Aventis any of the intellectual property licensed hereunder (or any
embodiment thereof) pursuant to this Section 14.5, Sanofi-Aventis shall have the
right to perform the obligations of Exelixis hereunder with respect to such
intellectual property, but neither such provision nor such performance by
Sanofi-Aventis shall release Exelixis from any such obligation or liability for
failing to perform it.

(c) All rights, powers and remedies of Sanofi-Aventis provided herein are in
addition to and not in substitution for any and all other rights, powers and
remedies now or hereafter existing at law or in equity (including Title 11) in
the event of the commencement of a Title 11 case by or against Exelixis.
Sanofi-Aventis, in addition to the rights, power and remedies expressly provided
herein, shall be entitled to exercise all other such rights and powers and
resort to all other such remedies as may now or hereafter exist at law or in
equity (including under Title 11) in such event. The Parties agree that they
intend the foregoing Sanofi-Aventis rights to extend to the maximum extent
permitted by law and any provisions of applicable contracts with Third Parties,
including for purposes of Title 11, (i) the right of access to any intellectual
property (including all embodiments thereof) of Exelixis or any Third Party with
whom Exelixis contracts to perform an obligation of Exelixis under this
Agreement, and, in the case of the Third Party, which is necessary for the
development, registration and manufacture of licensed products and (ii) the
right to contract directly with any Third Party described in (i) in

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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this sentence to complete the contracted work. Any intellectual property
provided pursuant to the provisions of this Section 14.5 shall be subject to the
licenses set forth elsewhere in this Agreement and the payment obligations of
this Agreement, which shall be deemed to be royalties for purposes of Title 11.

15.6 Force Majeure. Each Party shall be excused from the performance of its
obligations under this Agreement to the extent that such performance is
prevented by force majeure (defined below) and the nonperforming Party promptly
provides notice of the prevention to the other Party. Such excuse shall be
continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition. For
purposes of this Agreement, “force majeure” shall include conditions beyond the
control of the Parties, including an act of God, war, civil commotion, labor
strike or lock-out, epidemic, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake,
storm or like catastrophe. The payment of invoices due and owing hereunder shall
in no event be delayed by the payer because of a force majeure affecting the
payer.

15.7 Notices. Any notices given under this Agreement shall be in writing,
addressed to the Parties at the following addresses, and delivered by person, by
facsimile (with receipt confirmation), or by FedEx or other reputable courier
service. Any such notice shall be deemed to have been given: (a) as of the day
of personal delivery; (b) one (1) day after the date sent by facsimile service;
or (c) on the day of successful delivery to the other Party confirmed by the
courier service. Unless otherwise specified in writing, the mailing addresses of
the Parties shall be as described below.

 

For Exelixis:   

Exelixis, Inc.

170 Harbor Way

P.O. Box 511

South San Francisco, CA 94083

Attention: Executive Vice President and General Counsel

With a copy to:   

Cooley Godward LLP

Five Palo Alto Square

3000 El Camino Real

Palo Alto, CA 94306

Attention: Marya A. Postner, Esq.

For Sanofi-Aventis:   

Sanofi-Aventis

174 Avenue de France

75013 Paris, France

Attn: General Counsel

Furthermore, a copy of any notices required or given under Section 10.4(c) of
this Agreement shall also be addressed as set forth in Section 10.4(c).

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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15.8 Maintenance of Records Required by Law or Regulation. Each Party shall keep
and maintain all records required by law or regulation with respect to Products
and shall make copies of such records available to the other Party upon request.

15.9 Assignment.

(a) Neither Party may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the other (such
consent to not be unreasonably withheld, delayed or conditioned), except a Party
may make such an assignment without the other Party’s consent to an Affiliate or
to a Third Party successor to substantially all of the business of such Party to
which this Agreement relates, whether in a merger, sale of stock, sale of assets
or other transaction; provided that any such permitted successor or assignee of
rights and/or obligations hereunder is obligated, by reason of operation of law
or pursuant to a written agreement with the other Party, to assume performance
of this Agreement or such rights and/or obligations; and provided, further, that
if assigned to an Affiliate, the assigning Party shall remain jointly and
severally responsible for the performance of this Agreement by such Affiliate.
Any permitted assignment shall be binding on the successors of the assigning
Party. Any assignment or attempted assignment by either Party in violation of
the terms of this Section 15.9(a) shall be null and void and of no legal effect.

(b) In the event that a Party is acquired by a Third Party (such Third Party,
hereinafter referred to as an “Acquiror”), then the intellectual property of
such Acquiror held or developed by such Acquiror (whether prior to or after such
acquisition) shall be excluded from the intellectual property definitions under
this Agreement, and such Acquiror (and Affiliates of such Acquiror which are not
controlled by (as defined in Section 1.1) the acquired Party itself) shall be
excluded from “Affiliate” solely for purposes of the applicable components of
the intellectual property definitions herein, in all such cases if and only if:
(a) the acquired Party remains a wholly-owned subsidiary of the Acquiror;
(b) all intellectual property of the acquired Party and all research and
development assets and operations of the acquired Party, in each case relating
to Collaboration Compounds, remain with the acquired Party and are not
transferred to the Acquiror or another Affiliate of the Acquiror; (c) the
scientific and development activities with respect to Collaboration Compounds of
the acquired Party and the Acquiror (if any) are maintained separate and
distinct, and (d) there is no exchange of Confidential Information relating to
Collaboration Compounds between the acquired Party and the Acquiror. For
clarity, in the event that a Party is acquired by an Acquiror and each of the
criteria described in subsections (a) through (d) is not satisfied, then the
intellectual property of such Acquiror shall be included within the intellectual
property definitions herein. Any permitted assignment shall be binding on the
successors of the assigning Party.

15.10 Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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15.11 Severability. If any of the provisions of this Agreement are held to be
invalid or unenforceable by any court of competent jurisdiction from which no
appeal can be or is taken, the provision shall be considered severed from this
Agreement and shall not serve to invalidate any remaining provisions hereof. The
Parties shall make a good faith effort to replace any invalid or unenforceable
provision with a valid and enforceable one such that the objectives contemplated
by the Parties when entering this Agreement may be realized.

15.12 Independence. Subject to the terms of this Agreement, the activities and
resources of each Party shall be managed by such Party, acting independently and
in its individual capacity. The relationship between Exelixis and Sanofi-Aventis
is that of independent contractors and neither Party shall have the power to
bind or obligate the other Party in any manner.

15.13 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or
any waiver as to a particular default or other matter shall not constitute a
waiver of such Party’s rights to the future enforcement of its rights under this
Agreement, excepting only as to an express written and signed waiver as to a
particular matter for a particular period of time.

15.14 Construction of this Agreement. Except where the context otherwise
requires, wherever used, the use of any gender shall be applicable to all
genders, and the word “or” is used in the inclusive sense. When used in this
Agreement, “including” means “including without limitation”. References to
either Party include the successors and permitted assigns of that Party. The
headings of this Agreement are for convenience of reference only and in no way
define, describe, extend or limit the scope or intent of this Agreement or the
intent of any provision contained in this Agreement. The Parties have each
consulted counsel of their choice regarding this Agreement, and, accordingly, no
provisions of this Agreement shall be construed against either Party on the
basis that the Party drafted this Agreement or any provision thereof. If the
terms of this Agreement conflict with the terms of any Exhibit, then the terms
of this Agreement shall govern. The official text of this Agreement and any
Exhibits hereto, any notice given or accounts or statements required by this
Agreement, and any dispute proceeding related to or arising hereunder, shall be
in English. In the event of any dispute concerning the construction or meaning
of this Agreement, reference shall be made only to this Agreement as written in
English and not to any other translation into any other language.

15.15 Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document. Counterparts may be signed and delivered
by facsimile, or electronically in PDF format, each of which shall be binding
when sent.

[Signature page follows.]

 

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Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their proper officers. The date that this Agreement is signed shall
not be construed to imply that the document was made effective on that date.

 

EXELIXIS, INC. /s/ GEORGE SCANGOS By:   George A. SCANGOS, PhD Title:  
President and Chief Executive Officer Date:   May 27, 2009 SANOFI-AVENTIS /s/
Jérôme CONTAMINE By:   Jérôme CONTAMINE Title:   Executive Vice President, Chief
Financial Officer Date:   May 27, 2009 /s/ Laurence DEBROUX By:   Laurence
DEBROUX Title:   Senior Vice President, Chief Strategic Officer Date:   May 27,
2009

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 1.88

Selectivity Panel & Upstate Panel

[ * ]

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 1.91

Target Potency Threshold

[ * ]

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 1.92

Target Specificity Threshold

[ * ]

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 2.2

Research Plan

[ * ]

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 2.3(b)(i)

[ * ] Compounds [ * ] as of the Effective Date

[ * ]

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 2.3(b)(ii)

[ * ] Compounds [ * ] as of the Effective Date

[ * ]

 

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brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 5.2(d)

Form of [ * ] Development Report

[ * ]

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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Exhibit 6.3

Form of Trademark License

TRADEMARK LICENSE AGREEMENT

THIS TRADEMARK LICENSE AGREEMENT (“Agreement”), effective as of _____________,
(the “Effective Date”), is entered into by and between EXELIXIS, INC., a
Delaware corporation, having its principal place of business at 170 Harbor Way,
P.O. Box 511, South San Francisco, California (hereafter “Exelixis” or
“Licensor”), and SANOFI-AVENTIS, a French company, having an address at 174,
Avenue de France, 75013 Paris, France (hereafter “Sanofi-Aventis” or
“Licensee”).

WHEREAS, Exelixis and Sanofi-Aventis entered into a Collaboration Agreement
executed as of [date] (the “Collaboration Agreement”) for the purposes of
researching, developing and commercializing certain products; and

WHEREAS Licensor currently owns certain corporate name and logo marks, and
desires to license the use of said marks to Licensee pursuant to the
restrictions set forth below; and

WHEREAS, Licensee desires authorization from Licensor to use the marks in the
Territory pursuant to the restrictions set forth below;

NOW THEREFORE, the Parties agree as follows:

 

1. DEFINITIONS

Capitalized terms used in this Agreement (other than the headings of the
Sections or Articles) have the following meanings set forth in this Article 1,
or, if not listed in this Article 1, the meanings as designated in the text of
this Agreement. If a capitalized term is not defined in this Article 1 or in the
text of this Agreement, and that capitalized term is defined within the License
Agreement, the definition as set forth in the Collaboration Agreement shall
apply.

“Commercialization” shall mean to promote, market, distribute, sell (and offer
for sale or contract to sell) or provide product support for a Product,
including by way of example: (a) detailing and other promotional activities in
support of a Product; (b) advertising and public relations in support of a
Product, including market research, development and distribution of

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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selling, advertising and promotional materials, field literature,
direct-to-consumer advertising campaigns, media/journal advertising, and
exhibiting at seminars and conventions; (c) developing reimbursement programs
and information and data specifically intended for national accounts, managed
care organizations, governmental agencies (e.g., federal state and local), and
other group purchasing organizations, including pull-through activities;
(d) co-promotion activities not included in the above; (e) conducting Medical
Education Activities and journal advertising; and (f) conducting Phase IV
Clinical Trials.

“Major European Countries” shall mean France, Germany, Spain, Italy, and the
United Kingdom.

“Marks” shall mean the Exelixis marks set forth in Schedule A to this Agreement,
as such schedule may be amended from time to time pursuant to Section 7.1.

“Product” shall have the meaning set forth in the Collaboration Agreement.

“Term” shall have the meaning set forth in Section 4.1.

“Territory” shall mean [ * ].

“Third Party” shall mean any entity other than: (a) Exelixis;
(b) Sanofi-Aventis; or (c) an Affiliate of either Party.

 

2. License Grant.

2.1. License Grant. Subject to the terms and conditions of this Agreement,
Licensor hereby grants to Licensee for the Term a nonexclusive, sublicensable
(solely in accordance with Section 5.3), nonassignable (except as set forth in
Section 7.2), and royalty-free license to use the Marks throughout the Territory
solely in connection with the Commercialization of the Products to identify
Exelixis as the licensor of the Products, provided that such use of the Marks
satisfies all provisions of Section 2.2 and Article 3.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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2.2. Compliance. The Marks may only be used on Products that are Commercialized
in accordance with applicable law and current pharmaceutical industry standards
of quality, including the terms of all applicable Regulatory Approvals.

 

3. Use and Display of Trademarks.

3.1. Licensee shall use the Marks on labels, packaging and promotional/marketing
materials for or in connection with the Products provided that and only so long
as such use complies with applicable laws and market practice in the country of
use.

3.2. Licensee shall be obligated to display the Marks [ * ] used in connection
with the Commercialization of the Product. The display of the Marks on the
aforementioned packaging labels or marketing and promotional material shall be [
* ], provided however that Licensee shall not display the Marks in such a manner
to suggest that any party (including Licensee) other than Licensor owns the
Marks.

3.3. In the event of an uncured material breach of the License Agreement by
Licensor, or any bankruptcy or insolvency of Licensor, this Agreement (including
the license set forth in Section 2.1) shall remain in effect but Licensee shall
no longer be obligated pursuant to the preceding Section to continue using any
of the Marks

3.4. Licensee shall use the Marks upon or in relation to the Products only in
such manner where the distinctiveness, reputation, and validity of the Marks
shall not be impaired. Without prejudice to the generality of the foregoing,
Licensee shall ensure in particular that the Marks are correctly spelled, and
that any text, graphics, or designs adjacent to the Marks do not put the Marks
or Licensor in a negative or derogatory light. Licensee shall provide Licensor
with proposed Product packaging and corresponding marketing materials prior to
publication or shipment of any Product under the Marks.

 

-3-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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4. Term and Termination of Agreement.

4.1. The term of this Agreement (the “Term”) shall commence on the Effective
Date and shall continue in full force until the expiration or termination of the
Collaboration Agreement, unless earlier terminated pursuant to the terms and
conditions of this Agreement or pursuant to the mutual written agreement of
Licensor and Licensee.

4.2. In the event of a partial termination of the Collaboration Agreement, where
the Collaboration Agreement is terminated only in respect to certain Products or
certain countries within the Territory, this Agreement shall terminate with
respect to those Products and countries in the Territory for which the
Collaboration Agreement terminated and this Agreement shall remain in effect
with respect to those Products or countries in the Territory which continue to
be governed by the Collaboration Agreement.

4.3. In the event of Licensee committing a material breach of any of the terms
of this Agreement and failing to rectify same within [ * ] of receiving written
notification of such breach from Licensor, Licensor shall have the right to
terminate this Agreement upon written notice to Licensee.

4.4. Licensor shall also have the right to terminate this Agreement upon written
notice to Licensee if, in Licensor’s reasonable discretion, Licensee’s use of
the Marks tarnishes, blurs, or dilutes the quality associated with the Marks or
the associated goodwill and Licensee fails to rectify same within [ * ].

4.5. In the event of termination of this Agreement, the following provisions of
this Agreement shall survive: Article 6; and Sections 7.4 and 7.10. In any
event, termination of this Agreement shall not relieve the Parties of any
liability which accrued hereunder prior to the effective date of such
termination nor preclude either Party from pursuing all rights and remedies it
may have hereunder or at law or in equity with respect to any breach of this
Agreement nor prejudice either Party’s right to obtain performance of any
obligation.

 

-4-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

5. Licensor’s Exclusive Interest in the Marks.

5.1. Licensor hereby warrants to Licensee that Licensor is the owner of the
Marks and retains all rights, title and interest in and to the Marks. This
Agreement does not grant to Licensee any proprietary right of any of Licensor’s
Marks, other than use of the Marks as set forth in this Agreement.

5.2. In the event that management or in-house counsel for Licensee becomes aware
of a suspected infringement of a Mark by a Third Party, Licensee shall notify
Licensor promptly in writing. Licensee shall provide the same level of
disclosure to Licensor’s in-house counsel concerning suspected infringement of a
Mark as Licensee would provide to its own in-house counsel with respect to
suspected infringement of its own mark. As between the Parties, Licensor shall
have the sole right, but shall not be obligated, to bring an action with respect
to such suspected infringement at its own expense, in its own name and entirely
under its own direction and control.

5.3. In the event that Licensee grants to a Third Party a sublicense of its
rights under the Collaboration Agreement to Commercialize one or more Products
in one or more countries in the Territory, Licensee shall enter into a
sublicense agreement with such Third Party (the “Sublicensee”) that grants the
Sublicensee a sublicense of the Licensee’s rights pursuant to Section 2.1 with
respect to such Products in such countries in the Territory. Each such
sublicense agreement shall be under the same terms and conditions as this
Agreement.

5.4. Licensee agrees that it will take no action adverse to or inconsistent with
Licensor’s ownership of the Marks, including without limitation seeking to
register any of the Marks in the Territory, or opposing, disputing, or assisting
others in opposing or disputing Licensor’s ownership of the Marks in any way.

 

-5-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

5.5. Licensee acknowledges that all use of the Marks and all rights and goodwill
attached to or arising out of such use, shall accrue to the benefit of Licensor.
Licensee shall at any time, whether during or after the Term, execute any
documents that shall reasonably be required by Licensor to confirm Licensor’s
ownership of the Marks.

 

6. Governing Law; Venue.

6.1. This Agreement shall be construed in accordance with, and governed in all
respects by, the internal laws of the State of New York, without regard to
conflict of law rules.

6.2. Unless otherwise set forth in this Agreement, in the event of any dispute,
controversy or claim arising out of, relating to or in connection with any
provision of the Agreement, the Parties shall try to settle their differences
amicably between themselves first, by referring the disputed matter to the
Party’s respective Executive Officers. Either Party may initiate such informal
dispute resolution by sending written notice of the dispute to the other Party,
and, within [ * ] after such notice, such Executive Officers shall meet for
attempted resolution by good faith negotiations. If such Executive Officers are
unable to resolve such dispute within [ * ] of their first meeting for such
negotiations, either Party may seek to have such dispute resolved in any U.S.
federal or state court of competent jurisdiction and appropriate venue;
provided, that if such suit includes a Third Party claimant or defendant, and
jurisdiction and venue with respect to such Third Party appropriately resides
outside the U.S., then in any other jurisdiction or venue permitted by
applicable law; and further provided, that any dispute, controversy or claim
arising out of, relating to or in connection with any Mark shall be submitted to
a court of competent jurisdiction in the territory in which such Mark were
granted or arose.

 

7. Miscellaneous.

7.1. Entire Agreement; Amendments. This Agreement sets forth the complete, final
and exclusive agreement and all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties hereto with
respect to the Marks and supersedes and terminates all prior agreements and
understandings between the Parties with respect thereto. For clarity, this
Agreement satisfies the obligations set forth in Section 6.3 of the
Collaboration Agreement to enter into a Trademark License Agreement but does not
supersede or terminate any portion of the Collaboration Agreement. No subsequent

 

-6-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

alteration, amendment, change or addition to this Agreement shall be binding
upon the Parties unless reduced to writing and signed by an authorized officer
of each Party. Notwithstanding the foregoing, and subject to Section 6.3 (d) of
the Collaboration Agreement, Licensor may revise Schedule A upon written notice
to Licensee.

7.2. Assignment. Neither Party may assign or transfer this Agreement or any
rights or obligations hereunder without the prior written consent of the other
(such consent to not be unreasonably withheld, delayed or conditioned), except a
Party may make such an assignment without the other Party’s consent to an
Affiliate or to a Third Party successor to all or substantially all of the
business of such Party to which this Agreement relates, whether in a merger,
sale of stock, sale of assets or other transaction; provided that any such
permitted successor or assignee of rights and/or obligations hereunder is also
the permitted successor or assignee of such Party’s rights and obligations
pursuant to the Collaboration Agreement and is obligated, by reason of operation
of law or pursuant to a written agreement with the other Party, to assume
performance of this Agreement or such rights and/or obligations; and provided,
further, that if assigned to an Affiliate, the assigning Party shall remain
jointly and severally responsible for the performance of this Agreement by such
Affiliate. Any permitted assignment shall be binding on the successors of the
assigning Party. Any assignment or attempted assignment by either Party in
violation of the terms of this Section 7.2 shall be null and void and of no
legal effect.

7.3. Mutual Authority. Each Party represents and warrants to the other Party as
of the Effective Date that: (a) it has the authority and right to enter into and
perform this Agreement, (b) this Agreement is a legal and valid obligation
binding upon it and is enforceable in accordance with its terms, subject to
applicable limitations on such enforcement based on bankruptcy laws and other
debtors’ rights, and (c) its execution, delivery and performance of this
Agreement shall not conflict in any material fashion with the terms of any other
agreement or instrument to which it is or becomes a party or by which it is or
becomes bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having authority over it.

 

-7-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

7.4. Confidentiality. All Information disclosed by one Party to the other Party
pursuant to this Agreement shall be “Confidential Information” and the Parties
shall have the rights and obligations with respect thereto that are set forth in
Article 11 of the Collaboration Agreement. The Parties acknowledge that the
terms of this Agreement shall be treated as Confidential Information of both
Parties pursuant to the Collaboration Agreement and the Parties shall have the
rights and obligations with respect thereto that are set forth in Article 11 of
the Collaboration Agreement with respect to the terms of the Collaboration
Agreement.

7.5. Notices. Any notices given under this Agreement shall be in writing,
addressed to the Parties at the following addresses, and delivered by person, by
facsimile (with receipt confirmation), or by FedEx or other reputable courier
service. Any such notice shall be deemed to have been given: (a) as of the day
of personal delivery; (b) one (1) day after the date sent by facsimile service;
or (c) on the day of successful delivery to the other Party confirmed by the
courier service. Unless otherwise specified in writing, the mailing addresses of
the Parties shall be as described below.

 

For Exelixis:

   Exelixis, Inc.    249 East Grand Avenue    P.O. Box 511    So. San Francisco,
CA 94083-0511    Attention: EVP, General Counsel    Fax:

With a copy to:

   Cooley Godward Kronish LLP    Five Palo Alto Square    3000 El Camino Real   
Palo Alto, CA 94306    Attention: Marya Postner, Esq.

For Sanofi-Aventis:

   Sanofi-Aventis    174 Avenue de France    75013 Paris, France    Attention:
EVP, General Counsel    Fax: +33.1.53.77.43.03

 

-8-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

7.6. Further Actions. Each Party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

7.7. Severability. If any of the provisions of this Agreement are held to be
invalid or unenforceable by any court of competent jurisdiction from which no
appeal can be or is taken, the provision shall be considered severed from this
Agreement and shall not serve to invalidate any remaining provisions hereof. The
Parties shall make a good faith effort to replace any invalid or unenforceable
provision with a valid and enforceable one such that the objectives contemplated
by the Parties when entering this Agreement may be realized.

7.8. No Waiver. Any delay in enforcing a Party’s rights under this Agreement or
any waiver as to a particular default or other matter shall not constitute a
waiver of such Party’s rights to the future enforcement of its rights under this
Agreement, excepting only as to an express written and signed waiver as to a
particular matter for a particular period of time.

7.9. Construction of this Agreement. Except where the context otherwise
requires, wherever used, the use of any gender shall be applicable to all
genders, and the word “or” are used in the inclusive sense. When used in this
Agreement, “including” means “including without limitation”. References to
either Party include the successors and permitted assigns of that Party. The
headings of this Agreement are for convenience of reference only and in no way
define, describe, extend or limit the scope or intent of this Agreement or the
intent of any provision contained in this Agreement. The Parties have each
consulted counsel of their choice regarding this Agreement, and, accordingly, no
provisions of this Agreement shall be construed against either Party on the
basis that the Party drafted this Agreement or any provision thereof. If the
terms of this Agreement conflict with the terms of any Exhibit, then the terms
of this Agreement shall govern. The official text of this Agreement and any
Exhibits hereto, any notice given or accounts or statements required by this
Agreement, any records required by this Agreement, any correspondence between
the Parties, and any dispute proceeding related to or arising hereunder, shall
be in English. In the event of any dispute concerning the construction or
meaning of this Agreement, reference shall be made only to this Agreement as
written in English and not to any other translation into any other language.

 

-9-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

7.10. Indemnities.

7.10.1. Subject to Section 7.10.2, each Party hereby agrees to indemnify, defend
and hold harmless the other Party, its Affiliates, and their respective
directors, employees and agents from and against any and all Third Party suits,
claims, actions, demands, liabilities, expenses and/or losses, including
reasonable legal expenses and reasonable attorneys’ fees (“Losses”) to the
extent such Losses result from any: (a) breach of warranty by the indemnifying
Party contained in the Agreement; (b) breach of the Agreement or applicable law
by such indemnifying Party; (c) negligence or willful misconduct of the
indemnifying Party, its Affiliates or (sub)licensees, or their respective
directors, employees and agents in the performance of the Agreement; and/or
(d) breach of a contractual or fiduciary obligation owed by it to a Third Party
(including misappropriation of trade secrets).

7.10.2. As used herein, “Indemnitee” shall mean a party entitled to
indemnification under the terms of Section 7.10.1. A condition precedent to each
Indemnitee’s right to seek indemnification under such Section 7.10.1 is that
such Indemnitee shall: (a) inform the indemnifying Party under such applicable
Section of a Loss as soon as reasonably practicable after it receives notice of
the Loss; (b) if the indemnifying Party acknowledges that such Loss falls within
the scope of its indemnification obligations hereunder, permit the indemnifying
Party to assume direction and control of the defense, litigation, settlement,
appeal or other disposition of the Loss (including the right to settle the claim
solely for monetary consideration); provided, that the indemnifying Party shall
seek the prior written consent (such consent not to be unreasonably withheld,
delayed or conditioned) of any such Indemnitee as to any settlement which would
materially diminish or materially adversely affect the scope or duration of any
Marks licensed under this Agreement, would require any payment by such
Indemnitee, would require an admission of legal wrongdoing in any way on the
part of an Indemnitee, or would effect an amendment of this Agreement; and
(c) fully cooperate (including providing access to and copies of pertinent
records and making available for testimony relevant individuals subject to its
control) as reasonably requested by, and at the expense of, the indemnifying
Party in the defense of the Loss.

 

-10-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Provided that an Indemnitee has complied with all of the conditions described in
subsections 7.10.2(a) – (c), as applicable, the indemnifying Party shall provide
attorneys reasonably acceptable to the Indemnitee to defend against any such
Loss. Subject to the foregoing, an Indemnitee may participate in any proceedings
involving such Loss using attorneys of the Indemnitee’s choice and at the
Indemnitee’s expense. In no event may an Indemnitee settle or compromise any
Loss for which the Indemnitee intends to seek indemnification from the
indemnifying Party hereunder without the prior written consent of the
indemnifying Party, or the indemnification provided under such Section 7.10.1 as
to such Loss shall be null and void.

7.11. Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document. Counterparts may be signed and delivered
by facsimile, or electronically in PDF format, each of which shall be binding
when sent.

Signature page follows.

 

-11-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their proper officers.

 

For and On Behalf of Licensor EXELIXIS, INC. By:    

Print Name:    

Title:    

 

For and On Behalf of Licensee SANOFI-AVENTIS By:    

Print Name:    

Title:    

 

-12-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

SCHEDULE A TO TRADEMARK LICENSE AGREEMENT

THE MARKS

 

MARK

  

APP. NO. / REG. NO.

   CLASS

EXELIXIS

 

[United States]

   Reg. No. 2,823,801    005

EXELIXIS

 

[United States]

   App. No. 77/558,426    042

LOGO [g33474img008.jpg]

 

Old Exelixis Logo

 

[United States]

   Reg. No. 2,824,097    005

LOGO [g33474img009.jpg]

 

Old Exelixis Logo

 

[United States]

   Reg. No. 2,332,528    042

 

-13-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

LOGO [g33474img010.jpg]

 

New Exelixis Logo

 

[United States]

   App. No. 77/284,507    005

LOGO [g33474img0011.jpg]

 

New Exelixis Logo

 

[United States]

   App. No. 77/284,531    042

EXELIXIS

 

[European Union]

   Reg. No. 002607802    001

005

042

EXELIXIS

 

[European Union]

   Reg. No. 001243831    016

041

042

LOGO [g33474img012.jpg]

 

Old Exelixis Logo

 

[European Union]

   Reg. No. 3006772    001

005

042

 

-14-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

EXELIXIS

 

[Japan]

   Reg. No. 4599309    005

LOGO [g33474img013.jpg]

 

Old Exelixis Logo

 

[Japan]

   Reg. No. 4693262    005

 

-15-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Exhibit 7.2

Quality Responsibilities Relating to Development Candidates

THIS QUALITY LETTER (the “Letter”) is made and entered into as of ___________
[__], 2009 (the “Execution Date”) by and between EXELIXIS, INC., a Delaware
corporation having an address at 170 Harbor Way, P.O. Box 511, South San
Francisco, California 94083-0511 (“Exelixis”), and SANOFI-AVENTIS, a French
company, having an address at 174, Avenue de France, 75013 Paris, France
(“Sanofi-Aventis”). Exelixis and Sanofi-Aventis are sometimes referred to herein
individually as a “Party” and collectively as the “Parties”.

The Parties have entered into a Collaboration Agreement (the “Agreement”)
effective as of the Effective Date regarding the Collaboration Compounds. In
connection with the Agreement, this Letter is intended to set forth the Parties’
mutual understandings with respect to certain quality and Manufacturing
responsibilities with respect to: (A) the lots of drug substance for the
Exelixis Clinical Trials under Section 7.2 of the Agreement (each hereinafter
referred to as a “Drug Substance Lot”); and (B) the lots of finished drug
product for the Exelixis Clinical Trials under Section 7.2 of the Agreement
(each hereinafter referred to as a “Drug Product Lot”). Specifically, each of
the Parties hereby agrees to assume the responsibilities corresponding to such
Party as set forth on Schedule A hereto. Any capitalized terms used in this
Letter that are not otherwise defined herein shall have the meanings given to
them in the Agreement.

IN WITNESS WHEREOF, the Parties have executed this Letter in duplicate originals
by their proper officers. The date that this Letter is signed shall not be
construed to imply that the document was made effective on that date.

 

SANOFI-AVENTIS     EXELIXIS, INC. By:         By:     Title:         Title:    
Date:         Date:    

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

SCHEDULE A

[ * ]

 

-2-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Exhibit 7.3(a)

Information to be included for Transfer of Manufacturing Technology

[ * ]

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Exhibit 11.4

Exelixis Press Release

LOGO [g33474img007.jpg]

 

   Contact    Charles Butler   

Executive Director, Corporate

Communications & Investor Relations

   Exelixis, Inc, San Francisco   

650-837-7277

 

cbutler@exelixis.com

EXELIXIS AND SANOFI-AVENTIS SIGN GLOBAL LICENSE AGREEMENT FOR XL147 &

XL765 AND LAUNCH BROAD COLLABORATION FOR DISCOVERY OF PI3K INHIBITORS

-Exelixis receives $140 million upfront payment and guaranteed research funding-

Paris, France and South San Francisco, CA – May XX, 2009 — Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) and Exelixis, Inc. (Nasdaq: EXEL) today announced
a global license agreement for XL147 and XL765 and a broad collaboration for the
discovery of inhibitors of phosphoinositide-3 kinase (PI3K) for the treatment of
cancer. Activation of the PI3K pathway is a frequent event in human tumors,
promoting cell proliferation, survival, and resistance to chemotherapy and
radiotherapy. Under the license, Sanofi-aventis will have a worldwide exclusive
license to XL147 and XL765, which are currently in phase 1 and phase 1b/2
clinical trials, and will have sole responsibility for all subsequent clinical,
regulatory, commercial and manufacturing activities. Exelixis will participate
in conducting ongoing and potential future clinical trials and manufacturing
activities.

Under the discovery collaboration, Exelixis and Sanofi-aventis will combine
efforts in establishing several pre-clinical PI3K programs and jointly share
responsibility for research and preclinical activities related to
isoform-selective inhibitors of PI3K. Sanofi-aventis will have sole
responsibility for all subsequent clinical, regulatory, commercial and
manufacturing activities of any products arising from the collaboration;
however, Exelixis may be responsible for conducting certain clinical trials.

Sanofi-aventis will pay Exelixis a combined upfront cash payment of $140 million
under the license and collaboration. Exelixis will also receive guaranteed
research funding of $21 million over a three year research term under the
collaboration. For both the license and the collaboration, Exelixis will be
eligible to receive development, regulatory and commercial milestones of over $1
billion in the aggregate, as well as royalties on sales of any products
commercialized under the license and collaboration.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

“Sanofi-aventis has a track record of success in commercializing innovative
cancer therapies and is deeply committed to advancing the care of cancer
patients,” said George A. Scangos, Ph.D., president and chief executive officer
of Exelixis. “We believe that their expertise and resources will enable us to
move aggressively in advancing the development of XL147 and XL765 and other
potential PI3K inhibitors. The data generated to date in the XL147 and XL765
clinical programs suggest that these compounds may have utility in treating
diverse cancers. Sanofi-aventis and Exelixis are committed to realizing the full
potential of these compounds and other PI3K inhibitors to provide cancer
patients with new treatment options.”

The effectiveness of the license agreement is subject to antitrust clearance
under the Hart-Scott-Rodino Antitrust Improvements Act and other customary
regulatory approvals.

Oral Presentations

Clinical data from the phase 1 trials of XL147 and XL765 will be presented at
the American Society of Clinical Oncology Annual Meeting, which will be held
from May 29 to June 2, 2009 in Orlando, Florida:

 

  •  

“Phase 1 dose-escalation study of XL147, a PI3K inhibitor administered orally to
patients with solid tumors” will be presented on Monday, June 1, 2009, starting
at 1:30 p.m. local time (Abstract #3500)

 

  •  

“A Phase 1 dose-escalation study of the safety, pharmacokinetics (PK) and
pharmacodynamics of XL765, a PI3K/TORC1/TORC2 inhibitor administered orally to
patients (pts) with advanced solid tumors” will be presented on Monday, June 1,
2009 starting at 2:00 p.m. local time (Abstract #3502)

XL147 and XL765 target PI3K, which plays an important role in cell proliferation
and survival. Activation of the PI3K pathway is a frequent event in human
tumors, promoting cell proliferation, survival, and resistance to chemotherapy
and radiotherapy. XL765 also inhibits the mammalian target of rapamycin (mTOR),
which can be activated via upregulation of PI3K, or via PI3K-independent
mechanisms. mTOR is frequently activated in human tumors, and plays a central
role in tumor cell proliferation.

About Sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and
distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the
discovery and development of novel small molecule therapeutics for the treatment
of cancer and other serious diseases. The company is leveraging its fully
integrated drug discovery platform to fuel the growth of its development
pipeline, which is primarily focused on cancer. Currently, Exelixis’ broad
product pipeline includes investigational compounds in phase 3, phase 2, and
phase 1 clinical development. Exelixis has established strategic corporate
alliances with major pharmaceutical and biotechnology companies, including
Bristol-Myers Squibb, GlaxoSmithKline, Genentech, Boehringer Ingelheim, Wyeth
Pharmaceuticals, and Daiichi-Sankyo. For more information, please visit the
company’s web site at www.exelixis.com.

[FLS to be inserted by legal]

 

-2-

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Exhibit 11.4

Sanofi-Aventis Press Release

Sanofi-aventis and Biotechnology company Exelixis enter

into an Exclusive Global Alliance

for Novel Targeted Oncology Therapies

- Alliance includes a Global License Agreement for XL147 & XL765

and an Exclusive Collaboration for discovery of PI3K Inhibitors -

Paris, France - May 28, 2009 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and
Exelixis, Inc. (Nasdaq: EXEL) announced today a global license agreement for
XL147 and XL765 and an exclusive collaboration for the discovery of inhibitors
of phosphoinositide-3 kinase (PI3K) for the management of solid malignancies.
Activation of the PI3K pathway is a frequent event in human tumors, promoting
cell proliferation and cell survival, as well as resistance to chemotherapy and
radiotherapy.

Under the license agreement, sanofi-aventis will have an exclusive worldwide
license to XL147, an oral PI3K inhibitor, and XL765, an oral dual inhibitor of
PI3K and mTOR (mammalian target of rapamycin); both are currently in phase 1
clinical trials. Sanofi-aventis will have sole responsibility for all subsequent
clinical, regulatory, manufacturing and commercial activities. Exelixis will
participate in ongoing and potential future clinical trials.

Under the exclusive discovery collaboration, sanofi-aventis and Exelixis will
combine research efforts to establish several preclinical programs related to
isoform-selective inhibitors of PI3K. Sanofi-aventis will have sole
responsibility for all subsequent clinical, regulatory, commercial and
manufacturing activities of the products that result from the collaboration.
However, Exelixis may be responsible for conducting certain clinical trials.

“We are very excited about integrating such novel targeted therapies with high
therapeutic potential in our portfolio,” said Marc Cluzel, Senior Vice-President
R&D, sanofi-aventis. “We look forward to combining our efforts with Exelixis to
develop innovative drugs in the best interest of patients suffering from
cancers. This alliance is aligned with our strategy to create value through
strategic partnerships that deliver new therapeutic options”.

 

[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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

Under the terms of the agreements, sanofi-aventis will pay Exelixis an upfront
cash payment as well as development and regulatory milestone payments that could
reach over $1 billion in aggregate for existing and future programmes under both
agreements. In addition, Exelixis will be entitled to receive royalties and
commercial milestones on sales when products are commercialized.

The license agreement is subject to antitrust clearance under the
Hart-Scott-Rodino Antitrust Improvements Act.

***

About PI3K inhibitors

The phosphoinositide-3-kinase (PI3K) pathway is triggered in normal cells upon
exposure to growth factors. It regulates a cascade of proliferation and survival
signals. The PI3K pathway is one of the primary deregulated signaling pathways
in human cancer. Activation of the PI3K pathway is a frequent event in human
tumors, promoting cell proliferation, survival, and resistance to chemotherapy
and radiotherapy. Novel therapeutics impacting the PI3K pathway, alone or in
combination, are therefore considered to have a high therapeutic potential.

About XL147 and XL765

XL147 is an orally available small molecule inhibitor of
phosphoinositide-3-kinase (PI3K). XL765 is a orally available small molecule,
dual inhibitor of PI3K and mTOR (mammalian target of rapamycin). mTOR can be
activated via upregulation of PI3K, or via PI3K-independent mechanisms. mTOR is
frequently activated in human tumors, and plays a central role in tumor cell
proliferation.

About Exelixis

Exelixis, Inc. is a development-stage biotechnology company dedicated to the
discovery and development of novel small molecule therapeutics for the treatment
of cancer and other serious diseases. The company is leveraging its fully
integrated drug discovery platform to fuel the growth of its development
pipeline, which is primarily focused on cancer. Currently, Exelixis’ broad
product pipeline includes investigational compounds in Phase III, Phase II and
Phase I clinical development. Exelixis has established strategic corporate
alliances with major pharmaceutical and biotechnology companies, including
Bristol-Myers Squibb, GlaxoSmithKline, Genentech, Wyeth Pharmaceuticals and
Daiichi-Sankyo. For more information, please visit the company’s website at
http://www.exelixis.com.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and
distributes therapeutic solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. These statements include product
development, product potential projections and estimates and their underlying
assumptions, statements regarding plans, objectives, intentions and expectations
with respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally
identified by the words “expects,” “anticipates,”

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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“believes,” “intends,” “estimates,” “plans” and similar expressions. Although
sanofi-aventis’ management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various risks and
uncertainties, many of which are difficult to predict and generally beyond the
control of sanofi-aventis, that could cause actual results and developments to
differ materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMEA, regarding
whether and when to approve any drug, device or biological application that may
be filed for any such product candidates as well as their decisions regarding
labelling and other matters that could affect the availability or commercial
potential of such products candidates, the absence of guarantee that the
products candidates if approved will be commercially successful, the future
approval and commercial success of therapeutic alternatives as well as those
discussed or identified in the public filings with the SEC and the AMF made by
sanofi-aventis, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report
on Form 20-F for the year ended December 31, 2008. Other than as required by
applicable law, sanofi-aventis does not undertake any obligation to update or
revise any forward-looking information or statements.

 

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[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.