Document:

EX-10.18

 

Exhibit 10.18

Portions of this Exhibit Have Been

Omitted and Separately Filed with the Securities

And Exchange Commission with a Request

For Confidential Treatment

DISCOVERY AND PRECLINICAL DEVELOPMENT AGREEMENT

By and Between

AVENTIS PHARMACEUTICALS INC.

and

REGENERON PHARMACEUTICALS, INC.

Dated as of November 28, 2007

 

 

TABLE OF CONTENTS

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Page
	 	 	 	 	ARTICLE 1

DEFINITIONS
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	1.1	 	 	“Affiliate”

	 	 	1	 
	 	1.2	 	 	“Agreement”

	 	 	2	 
	 	1.3	 	 	“Alliance Manager”

	 	 	2	 
	 	1.4	 	 	“Antibody”

	 	 	2	 
	 	1.5	 	 	“Aventis Collaboration Agreement”

	 	 	2	 
	 	1.6	 	 	“Business Day”

	 	 	2	 
	 	1.7	 	 	“Commercially Reasonable Efforts”

	 	 	2	 
	 	1.8	 	 	“Competing Refused Candidate”

	 	 	2	 
	 	1.9	 	 	“Confidential Information”

	 	 	2	 
	 	1.10	 	 	“Contract Year”

	 	 	2	 
	 	1.11	 	 	“CPI”

	 	 	3	 
	 	1.12	 	 	“Damages”

	 	 	3	 
	 	1.13	 	 	“Default Interest Rate”

	 	 	3	 
	 	1.14	 	 	“Disclosing Party”

	 	 	3	 
	 	1.15	 	 	“Discovery Plan”

	 	 	3	 
	 	1.16	 	 	“Discovery Program”

	 	 	3	 
	 	1.17	 	 	“Discovery Program Costs”

	 	 	3	 
	 	1.18	 	 	“Effective Date”

	 	 	3	 
	 	1.19	 	 	“Excluded Candidates”

	 	 	3	 
	 	1.20	 	 	“Executive Officers”

	 	 	3	 
	 	1.21	 	 	“FDA”

	 	 	3	 
	 	1.22	 	 	“Force Majeure”

	 	 	3	 
	 	1.23	 	 	“FTE”

	 	 	3	 
	 	1.24	 	 	“FTE Cost”

	 	 	3	 
	 	1.25	 	 	“FTE Rate”

	 	 	4	 
	 	1.26	 	 	“GAAP”

	 	 	4	 
	 	1.27	 	 	“Governmental Authority”

	 	 	4	 
	 	1.28	 	 	“IAS/IFRS”

	 	 	4	 
	 	1.29	 	 	“IFM”

	 	 	4	 
	 	1.30	 	 	“Immunoconjugate”

	 	 	4	 
	 	1.31	 	 	“IND”

	 	 	4	 
	 	1.32	 	 	“IND Preparation”

	 	 	4	 
	 	1.33	 	 	“Indemnified Party”

	 	 	4	 
	 	1.34	 	 	“Indemnifying Party”

	 	 	4	 
	 	1.35	 	 	“Initial Development Plan”

	 	 	4	 
	 	1.36	 	 	“Investor Agreement”

	 	 	4	 

i

 

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Page
	 	1.37	 	 	“Joint Research Committee” or “JRC”

	 	 	5	 
	 	1.38	 	 	“Joint Inventions”

	 	 	5	 
	 	1.39	 	 	“Joint Patent Rights”

	 	 	5	 
	 	1.40	 	 	“Know-How”

	 	 	5	 
	 	1.41	 	 	“Law” or “Laws”

	 	 	5	 
	 	1.42	 	 	“Lead Candidate”

	 	 	5	 
	 	1.43	 	 	“License and Collaboration Agreement”

	 	 	5	 
	 	1.44	 	 	“Licensed Product”

	 	 	5	 
	 	1.45	 	 	“Licensed Refused Sanofi Candidate”

	 	 	5	 
	 	1.46	 	 	“Manufacturing Cost”

	 	 	5	 
	 	1.47	 	 	“Maximum Annual Discovery Program Costs”

	 	 	5	 
	 	1.48	 	 	“Mice”

	 	 	5	 
	 	1.49	 	 	“Mice-Derived Therapeutic (or Diagnostic) Candidate” or “MTC”

	 	 	5	 
	 	1.50	 	 	“Modified Clause”

	 	 	5	 
	 	1.51	 	 	“Net Sales”

	 	 	5	 
	 	1.52	 	 	“Opt-In Notice”

	 	 	7	 
	 	1.53	 	 	“Opt-In Period”

	 	 	7	 
	 	1.54	 	 	“Opt-In Report”

	 	 	7	 
	 	1.55	 	 	“Opt-In Rights”

	 	 	7	 
	 	1.56	 	 	“Out-of-Pocket Costs”

	 	 	7	 
	 	1.57	 	 	“Party” or “Parties”

	 	 	7	 
	 	1.58	 	 	“Patent Application”

	 	 	7	 
	 	1.59	 	 	“Patent Rights”

	 	 	7	 
	 	1.60	 	 	“Patents”

	 	 	7	 
	 	1.61	 	 	“Person”

	 	 	7	 
	 	1.62	 	 	“Phase I Clinical Trial”

	 	 	7	 
	 	1.63	 	 	“Product Candidate”

	 	 	7	 
	 	1.64	 	 	“Product Patent Rights”

	 	 	7	 
	 	1.65	 	 	“Program Target”

	 	 	8	 
	 	1.66	 	 	“Publishing Party”

	 	 	8	 
	 	1.67	 	 	“Receiving Party”

	 	 	8	 
	 	1.68	 	 	“Refused Candidate”

	 	 	8	 
	 	1.69	 	 	“Regeneron”

	 	 	8	 
	 	1.70	 	 	“Regeneron Indemnitees”

	 	 	8	 
	 	1.71	 	 	“Regeneron Intellectual Property”

	 	 	8	 
	 	1.72	 	 	“Regeneron Know-How”

	 	 	8	 
	 	1.73	 	 	“Regeneron Patent Rights”

	 	 	8	 
	 	1.74	 	 	“Regeneron Sole Inventions”

	 	 	8	 
	 	1.75	 	 	“Regeneron Target IP”

	 	 	8	 
	 	1.76	 	 	“Regulatory Authority”

	 	 	8	 
	 	1.77	 	 	“Royalty Product”

	 	 	8	 
	 	1.78	 	 	“Royalty Term”

	 	 	8	 
	 	1.79	 	 	“Sanofi”

	 	 	8	 
	 	1.80	 	 	“Sanofi Divested Antibody”

	 	 	8	 
	 	1.81	 	 	“Sanofi Indemnitees”

	 	 	8	 
	 	1.82	 	 	“Sanofi Intellectual Property”

	 	 	9	 

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	 	 	 	 	 	 	Page
	 	1.83	 	 	“Sanofi Know-How”

	 	 	9	 
	 	1.84	 	 	“Sanofi Patent Rights”

	 	 	9	 
	 	1.85	 	 	“Sanofi Sole Inventions”

	 	 	9	 
	 	1.86	 	 	“Sanofi Sole Projects”

	 	 	9	 
	 	1.87	 	 	“Sanofi Targets”

	 	 	9	 
	 	1.88	 	 	“Sanofi Target IP”

	 	 	9	 
	 	1.89	 	 	“Sole Inventions”

	 	 	9	 
	 	1.90	 	 	“Solely Developed Immunoconjugate”

	 	 	9	 
	 	1.91	 	 	“Stock Purchase Agreement”

	 	 	9	 
	 	1.92	 	 	“Tail Period”

	 	 	9	 
	 	1.93	 	 	“Target”

	 	 	9	 
	 	1.94	 	 	“Target List”

	 	 	9	 
	 	1.95	 	 	“Term”

	 	 	9	 
	 	1.96	 	 	“Territory”

	 	 	9	 
	 	1.97	 	 	“Third Party”

	 	 	10	 
	 	1.98	 	 	“Third Party Opportunities”

	 	 	10	 
	 	1.99	 	 	“Valid Claim”

	 	 	10	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 2
	 	 	 	 
	 	 	 	 	DISCOVERY PROGRAM
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	2.1	 	 	Discovery Program

	 	 	10	 
	 	2.2	 	 	Term of the Discovery Program

	 	 	10	 
	 	2.3	 	 	Discovery Plans

	 	 	10	 
	 	2.4	 	 	Sanofi Targets

	 	 	11	 
	 	2.5	 	 	Commercially Reasonable Efforts; Compliance with Laws

	 	 	11	 
	 	2.6	 	 	Exchange of Information

	 	 	11	 
	 	2.7	 	 	Further Assurances and Transaction Approvals

	 	 	11	 
	 	2.8	 	 	Exclusive Discovery Program

	 	 	12	 
	 	2.9	 	 	Tail Period

	 	 	14	 
	 	2.10	 	 	Research Licenses; Licenses Generally

	 	 	15	 
	 	2.11	 	 	Immunoconjugates

	 	 	15	 
	 	2.12	 	 	Sanofi Target Licenses

	 	 	15	 
	 	2.13	 	 	Non-Exclusive License to Sanofi

	 	 	15	 
	 	2.14	 	 	Invention Assignment

	 	 	15	 
	 	2.15	 	 	Supply of VelociGeneÒ Mice

	 	 	16	 
	 	2.16	 	 	Option for VelocImmuneÒ License

	 	 	16	 
	 	2.17	 	 	Option for *******************, and other Antibody Know How Licenses

	 	 	16	 
	 	2.18	 	 	Third Party Platform Licenses

	 	 	16	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 3

JOINT RESEARCH COMMITTEE
	 	 	 	 
	 
	 	3.1	 	 	The Joint Research Committee

	 	 	16	 
	 	3.2	 	 	Alliance Management

	 	 	18	 
	 	3.3	 	 	Resolution of Governance Matters

	 	 	18	 
	 	3.4	 	 	Obligations of the Parties and their Affiliates

	 	 	19	 

iii

 

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Page
	 	 	 	 	ARTICLE 4

PAYMENTS
	 	 	 	 
	 
	 	4.1	 	 	Upfront Payment

	 	 	19	 
	 	4.2	 	 	Discovery Program Costs

	 	 	19	 
	 	4.3	 	 	Reports and Discovery Program Cost Payments

	 	 	20	 
	 	4.4	 	 	Royalty Payments for Royalty Products

	 	 	20	 
	 	4.5	 	 	Royalty Reporting

	 	 	20	 
	 	4.6	 	 	Payment Method and Currency

	 	 	21	 
	 	4.7	 	 	Late Payments

	 	 	21	 
	 	4.8	 	 	Taxes

	 	 	21	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 5

OPT-IN RIGHTS TO LICENSE PRODUCT CANDIDATES
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	5.1	 	 	Opt-In Rights to License Product Candidates

	 	 	21	 
	 	5.2	 	 	Process for Opt-In Rights

	 	 	22	 
	 	5.3	 	 	Initial Development Plan

	 	 	22	 
	 	5.4	 	 	Opt-In Exercise

	 	 	22	 
	 	5.5	 	 	Dll4 and REGN-88

	 	 	22	 
	 	5.6	 	 	Refused Candidates

	 	 	22	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 6

NEWLY CREATED INVENTIONS
	 	 	 	 
	 
	 	6.1	 	 	Ownership of Newly Created Intellectual Property

	 	 	23	 
	 	6.2	 	 	Prosecution and Maintenance of Patent Rights

	 	 	25	 
	 	6.3	 	 	Third Party Claims

	 	 	26	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 7

BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	7.1	 	 	Books and Records

	 	 	26	 
	 	7.2	 	 	Audits and Adjustments

	 	 	27	 
	 	7.3	 	 	IAS/IFRS/GAAP

	 	 	27	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 8

REPRESENTATIONS, WARRANTIES AND COVENANTS
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	8.1	 	 	Joint Representations and Warranties

	 	 	27	 
	 	8.2	 	 	Knowledge of Pending or Threatened Litigation

	 	 	28	 
	 	8.3	 	 	Additional Regeneron Representations, Warranties and Covenants

	 	 	28	 
	 	8.4	 	 	Disclaimer of Warranties

	 	 	29	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 9

CONFIDENTIALITY
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	9.1	 	 	Confidential Information

	 	 	29	 

iv

 

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Page
	 	9.2	 	 	Injunctive Relief

	 	 	31	 
	 	9.3	 	 	Publications

	 	 	31	 
	 	9.4	 	 	Disclosures Concerning this Agreement

	 	 	31	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 10

INDEMNITY
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	10.1	 	 	Indemnity and Insurance

	 	 	32	 
	 	10.2	 	 	Indemnity Procedure

	 	 	33	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 11

FORCE MAJEURE
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 12

TERM AND TERMINATION
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	12.1	 	 	Term

	 	 	35	 
	 	12.2	 	 	Termination For Material Breach

	 	 	35	 
	 	12.3	 	 	Termination for Insolvency

	 	 	35	 
	 	12.4	 	 	Termination by Sanofi on Notice

	 	 	36	 
	 	12.5	 	 	Termination for Breach of Standstill

	 	 	36	 
	 	12.6	 	 	Termination for Breach of License and Collaboration Agreement

	 	 	36	 
	 	12.7	 	 	Effect of Termination by Sanofi for Breach

	 	 	36	 
	 	12.8	 	 	Effect of Termination by Regeneron for Breach

	 	 	37	 
	 	12.9	 	 	Survival of Obligations

	 	 	38	 
	 	12.10	 	 	Return of Confidential Information

	 	 	38	 
	 	12.11	 	 	Special Damages

	 	 	39	 
	 	12.12	 	 	Termination by Sanofi At Will

	 	 	39	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 13

Arbitration
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	13.1
	 	Binding Arbitration

	 	 	39	 
	 	 	 	 	 
	 	 	 	 
	 	 	 	 	ARTICLE 14

MISCELLANEOUS
	 	 	 	 
	 	 	 	 	 
	 	 	 	 
	 	14.1	 	 	Governing Law; Submission to Jurisdiction

	 	 	41	 
	 	14.2	 	 	Waiver

	 	 	41	 
	 	14.3	 	 	Notices

	 	 	41	 
	 	14.4	 	 	Entire Agreement

	 	 	41	 
	 	14.5	 	 	Amendments

	 	 	41	 
	 	14.6	 	 	Interpretation

	 	 	42	 
	 	14.7	 	 	Severability

	 	 	42	 
	 	14.8	 	 	Assignment

	 	 	42	 
	 	14.9	 	 	Successors and Assigns

	 	 	42	 
	 	14.10	 	 	Affiliates

	 	 	42	 
	 	14.11	 	 	Counterparts

	 	 	43	 

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	 	 	 	 	 	 	Page
	 	14.12	 	 	Third Party Beneficiaries

	 	 	43	 
	 	14.13	 	 	Relationship of the Parties

	 	 	43	 
	 	14.14	 	 	Limitation of Damages

	 	 	43	 
	 	14.15	 	 	Non-Solicitation

	 	 	43	 
	 	14.16	 	 	No Strict Construction

	 	 	44	 

vi

 

Exhibit 10.18

DISCOVERY AND PRECLINICAL DEVELOPMENT AGREEMENT

     THIS DISCOVERY AND PRECLINICAL DEVELOPMENT AGREEMENT (“Agreement”), dated as of
November 28, 2007 (the “Effective Date”), is by and between AVENTIS PHARMACEUTICALS INC.
(“Sanofi”), a corporation organized under the laws of Delaware, having a principal place of
business at 55 Corporate Boulevard, Bridgewater, New Jersey 08807, an indirect wholly owned
subsidiary of Sanofi-Aventis, a company organized under the laws of France with its principal
headquarters at 174, avenue de France, 75103 Paris, France (“Sanofi Parent”), and REGENERON
PHARMACEUTICALS, INC., a corporation organized under the laws of New York and having a principal
place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591, USA
(“Regeneron”) (with each of Sanofi and Regeneron referred to herein individually as a
“Party” and collectively as the “Parties”).

     WHEREAS, Regeneron plans to undertake a broad therapeutic antibody discovery and development
program with the objective of identifying and validating potential drug discovery targets for the
purpose of discovering fully human monoclonal antibody product candidates against those targets
using its proprietary VelocImmune® and related suite of technologies; and

     WHEREAS, Sanofi is interested in funding and assisting with Regeneron’s plans to discover and
validate potential drug discovery targets for the purpose of discovering fully human monoclonal
antibody product candidates in exchange for an option to license certain rights to the resulting
fully human monoclonal antibodies under the terms set forth in this Agreement and in the License
and Collaboration Agreement (as further defined in Article 1 below) to be entered into
between the parties contemporaneously with the execution of this Agreement;

     NOW, THEREFORE, in consideration of the following mutual promises and obligations, and for
other good and valuable consideration the adequacy and sufficiency of which are hereby
acknowledged, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

     Capitalized terms used in this Agreement, whether used in the singular or plural, except as
expressly set forth herein, shall have the meanings set forth below:

     1.1 “Affiliate” shall mean, with respect to any Person, another Person which controls, is
controlled by, or is under common control with such Person. A Person shall be deemed to control
another Person if such Person possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of such Person, whether through the ownership of voting
securities, by contract, or otherwise. Without limiting the generality of the foregoing, a Person
shall be deemed to control another Person if any of the following conditions is met: (a) in the
case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the
stock or shares having the right to vote for the election of directors, and (b) in the case of
non-corporate
entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with
the power to direct the management and policies of such non-corporate entities. The Parties
acknowledge that in the case of certain entities organized under the laws of

 

 

certain countries
outside of the United States, the maximum percentage ownership permitted by law for a foreign
investor may be less than fifty percent (50%), and that in such case such lower percentage shall be
substituted in the preceding sentence, provided that such foreign investor has the power to
direct the management and policies of such entity. For purposes of this Agreement, in no event
shall Sanofi or any of its Affiliates be deemed Affiliates of Regeneron or any of its Affiliates
nor shall Regeneron or any of its Affiliates be deemed Affiliates of Sanofi or any of its
Affiliates. For purposes of this Agreement, neither Sanofi Pasteur nor Merial Limited, nor any of
their respective subsidiaries or joint ventures, shall be deemed to be Affiliates of Sanofi or any
of its Affiliates.

     1.2 “Agreement” shall have the meaning set forth in the introductory paragraph, including
all Schedules and Exhibits.

     1.3 “Alliance Manager” shall have the meaning set forth in Section 3.2.

     1.4 “Antibody” shall mean ******************************, and any composition or
formulation that incorporates or includes any of the foregoing.

     1.5 “Aventis Collaboration Agreement” shall mean the Collaboration Agreement, dated as of
September 5, 2003, by and between sanofi-aventis US (as successor in interest to Sanofi) and
Regeneron, as amended by the First Amendment, dated as of December 31, 2004, the Second Amendment,
dated as of January 7, 2005, the Third Amendment, dated as of December 21, 2005, the Fourth
Amendment, dated as of January 31, 2006, and Section 11.2 of the Stock Purchase Agreement, as the
same may be further amended from time to time.

     1.6 “Business Day” shall mean any day other than a Saturday, a Sunday or a day on which
commercial banks in New York, New York, United States or Paris, France are authorized or required
by Law to remain closed.

     1.7 “Commercially Reasonable Efforts” shall mean 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. Commercially Reasonable Efforts shall be determined on a Target-by-Target
and Antibody-by-Antibody (including MTCs) basis in view of conditions prevailing at the time, and
evaluated taking into account all relevant factors.

     1.8 “Competing Refused Candidate” shall mean any Refused Candidate having the same Target
as a Licensed Product (as long as such Licensed Product is licensed to Sanofi under the License and
Collaboration Agreement).

     1.9 “Confidential Information” shall have the meaning set forth in Section 9.1.

     1.10 “Contract Year” shall mean the period beginning on the Effective Date and ending on
December 31, 2008, and each succeeding twelve (12) month period thereafter during the term

2

 

of the
Discovery Program (except that the last Contract Year shall end on the effective date of any
termination or expiration of this Agreement).

     1.11 “CPI” shall mean the Consumer Price Index — All Urban Consumers published by the
United States Department of Labor, Bureau of Statistics (or its successor equivalent index).

     1.12 “Damages” shall have the meaning set forth in Section 10.1(a).

     1.13 “Default Interest Rate” shall have the meaning set forth in Section 4.7.

     1.14 “Disclosing Party” shall have the meaning set forth in Section 9.1.

     1.15 “Discovery Plan” shall have the meaning set forth in Section 2.3.

     1.16 “Discovery Program” shall mean all research and development activities to be performed
under this Agreement *************************************.

     1.17 “Discovery Program Costs”
shall mean all Out-of-Pocket Costs, FTE Costs and Manufacturing Costs incurred by Regeneron,
after the Effective Date directly in connection with the performance of the Discovery Program (and,
as such costs relate to a particular Licensed Product, ending on the last day of the month
preceding the month in which the Opt-In Notice for such Licensed Product is received by Regeneron).

     1.18 “Effective Date” shall have the meaning set forth in the introductory paragraph.

     1.19 “Excluded Candidates” shall mean Antibodies (including MTCs) against Targets set forth
in Schedule 1.19 as of the Effective Date and those Targets that will be notified by Sanofi to
Regeneron pursuant to the second sentence of Section 2.8(b)(i).

     1.20 “Executive Officers” shall mean the Chief Executive Officer of Regeneron and the most
senior Research and Development Officer of Sanofi Parent, or their respective designees with
equivalent decision-making authority with respect to matters under this Agreement.

     1.21 “FDA” shall mean the United States Food and Drug Administration and any successor
agency thereto.

     1.22 “Force Majeure” shall have the meaning set forth in Article 11.

     1.23 “FTE” shall mean a full time equivalent employee (i.e., one fully-committed or
multiple partially-committed employees aggregating to one full-time employee) employed by Regeneron
(or its Affiliate) who performs work under the Discovery Program, with such commitment of time and
effort to constitute one employee performing such work on a full-time basis, which for purposes
hereof shall be ******** hours per year.

     1.24 “FTE Cost” shall mean, for all activities performed under the Discovery Program, the
product of (a) the number of FTEs performing activities under the Discovery Program and (b) the FTE
Rate.

3

 

     1.25 “FTE Rate” shall mean $***** in the first Contract Year, such amount to be adjusted as
of January 1, 2009 and annually thereafter by the sum of (a) the percentage increase or decrease,
if any, in the CPI for the twelve (12) months ending June 30 of the Contract Year prior to the
Contract Year for which the adjustment is being made, ********************.

     1.26 “GAAP” shall mean generally accepted accounting principles as applicable in the United
States.

     1.27 “Governmental Authority” shall mean any court, agency, authority, department,
regulatory body, or other instrumentality of any government or country or of any national, federal,
state, provincial, regional, county, city, or other political subdivision of any such government or
any supranational organization of which any such country is a member.

     1.28
“IAS/IFRS” shall mean International Financial Reporting Standards adopted by the International
Accounting Standards Board.

     1.29 “IFM” shall have the meaning set forth in Section 2.11(d)(ii).

     1.30 “Immunoconjugate” shall mean an Antibody (or derivative or fragment thereof) linked to
a cytotoxic or any molecule potentially able to enhance the therapeutic activity of such Antibody
(or derivative or fragment thereof).

     1.31 “IND” shall mean, with respect to each Product Candidate, an Investigational New Drug
Application filed with the FDA with respect to such Product Candidate pursuant to 21 C.F.R. § 312
before the commencement of clinical trials involving such Product Candidate, including all
amendments and supplements to such application, or any equivalent filing with any Regulatory
Authority outside the United States.

     1.32 “IND Preparation” shall mean all drug development activities in support of a Lead
Candidate or Product Candidate up to the filing of the IND for the Phase I Clinical Trial,
including, but not limited to, assay development, sample analysis, preclinical toxicology,
preclinical pharmacokinetics and toxicokinetics, pharmacological assessment (if applicable), cell
line development and protein chemistry sciences, formulation development, clinical trial protocol
development, IND drafting and data compilation, and manufacturing preclinical and clinical
supplies.

     1.33 “Indemnified Party” shall have the meaning set forth in Section 10.2(a).

     1.34 “Indemnifying Party”
shall have the meaning set forth in Section 10.2(a).

     1.35
“Initial Development Plan” shall have the meaning set forth in Section 5.3.

     1.36 “Investor Agreement” shall mean the Investor Agreement by and between (a) Sanofi,
Sanofi Parent, sanofi-aventis US LLC, and Sanofi-Aventis Amerique du Nord and (b) Regeneron,
substantially in the form of Exhibit B to the Stock Purchase Agreement, which will be
entered into concurrently with the closing under the Stock Purchase Agreement.

4

 

     1.37 “Joint Research Committee” or “JRC” shall mean the Joint Research Committee
described in Section 3.1(a).

     1.38 “Joint Inventions” shall have the meaning set forth in Section 6.1(b).

     1.39 “Joint Patent Rights” shall mean Patent Rights that cover a Joint Invention.

     1.40 “Know-How” shall mean, with respect to each Party and its Affiliates, any and all
proprietary technical or scientific information, data, test results, knowledge, techniques,
discoveries, inventions, specifications, designs, trade secrets, regulatory filings and other
information (whether or not patentable or otherwise protected by trade secret Law) and that are not
disclosed or claimed by such Party’s Patents or Patent Applications.

     1.41 “Law” or “Laws” shall mean all laws, statutes, rules, regulations, orders,
judgments, injunctions, and/or ordinances of any Governmental Authority in the Territory.

     1.42 “Lead Candidate” shall mean, for any Program Target, each Antibody, including MTCs,
that satisfies the applicable criteria set forth in Schedule 1.42 and is selected by Regeneron to
begin IND Preparation under this Agreement.

     1.43 “License and Collaboration Agreement” shall mean the License and Collaboration
Agreement between the Parties, dated as of the date of this Agreement, the terms of which are
incorporated by reference into, and are part of, this Agreement.

     1.44 “Licensed Product” shall mean any Product Candidate for which Sanofi has exercised its
Opt-In Rights pursuant to Section 5.4 below.

     1.45 “Licensed Refused Sanofi Candidate” shall have the meaning set forth in Section
2.12.

     1.46 “Manufacturing Cost” shall mean the fully burdened cost (without mark-up) of
manufacturing Product Candidates and Lead Candidates for preclinical activities and Phase I
Clinical Trials (and, if agreed by the Parties other clinical trials), and the cost for providing
dedicated manufacturing capacity for Lead Candidates and Product Candidates, in each case, as
calculated in accordance with Schedule 1.46.

     1.47 “Maximum Annual Discovery Program Costs” shall have the meaning set forth in
Section 4.2.

     1.48 “Mice” shall mean ***************************.

     1.49 “Mice-Derived Therapeutic (or Diagnostic) Candidate” or “MTC” shall mean any
Antibody derived from Mice.

     1.50 “Modified Clause” shall have the meaning set forth in Section 14.7.

     1.51 “Net Sales” shall mean the gross amount invoiced for bona fide arms’ length sales of
Royalty Products in the Territory by or on behalf of a Party, or its Affiliates or sublicensees to

5

 

Third Parties, less the following deductions, determined in accordance with IAS/IFRS (or GAAP for
the US) consistently applied:

          (a) normal and customary trade, cash, quantity and free-goods allowances granted and taken
directly with respect to sales of such Royalty Products;

          (b) amounts repaid or credited by reason of defects, rejections, recalls, returns, rebates,
allowances and billing errors;

          (c) chargebacks and other amounts paid on sale or dispensing of Royalty Products;

          (d) Third Party cash rebates and chargebacks related to sales of Royalty Products, to the
extent allowed;

          (e) retroactive price reductions that are actually allowed or granted;

          (f) compulsory refunds, credits and rebates directly related to the sale of Royalty Products,
accrued, paid or deducted pursuant to agreements (including, but not limited to, managed care
agreements) or governmental regulations;

          (g) freight, postage, shipment and insurance costs (or wholesaler fees in lieu of those costs)
and customs duties incurred in delivering Royalty Products that are separately identified on the
invoice or other documentation;

          (h) sales taxes, excess duties, or other consumption taxes and compulsory payments to
Governmental Authorities or other governmental charges imposed on the sale of Royalty Products,
which are separately identified on the invoice or other documentation;

          (i) as agreed by the Parties, any other specifically identifiable costs or charges included in
the gross invoiced sales price of such Royalty Product falling within categories substantially
equivalent to those listed above and ultimately credited to customers or a Governmental Authority
or agency thereof;

          (j) invoiced amounts that are written off as uncollectible in accordance with a Party’s or its
Affiliates’ or sublicensees’ respective accounting principles as applied consistently

Net Sales in currency other than United States Dollars shall be translated into United States
Dollars according to the provisions of Section 4.6 of this Agreement.

Sales between the Parties, or between the Parties and their Affiliates or sublicensees, for resale,
shall be disregarded for purposes of calculating Net Sales. Any of the items set forth above that
would otherwise be deducted from the invoice price in the calculation of Net Sales but which are
separately charged to, and paid by, Third Parties shall not be deducted from the invoice price in
the calculation of Net Sales. In the case of any sale of a Royalty Product for consideration other
than cash, such as barter or countertrade, Net Sales shall be calculated on the fair market value
of the consideration received as agreed by the Parties. Solely for purposes of calculating Net
Sales, if a Party or its Affiliates or sublicensee sells such Royalty Products in the form of a
combination

6

 

product containing any Royalty Product and one or more active ingredients (whether
combined in a single formulation or package, as applicable, or formulated or packaged separately
but sold together for a single price in a manner consistent with the terms of this Agreement) (a
“Combination Product”), then prior to the first commercial sale of such Combination
Product, the Parties shall agree on the value of each component of such Combination Product and the
appropriate method for accounting for sale of such Combination Product. For the avoidance of
doubt, for the purposes of this Agreement, Immunoconjugates shall not be deemed Combination
Products.

     1.52 “Opt-In Notice” shall have the meaning set forth in Section 5.4.

     1.53 “Opt-In Period” shall have the meaning set forth in Section 5.4.

     1.54 “Opt-In Report” shall have the meaning set forth in Section 5.2.

     1.55 “Opt-In Rights” shall have the meaning set forth in Section 5.1.

     1.56 “Out-of-Pocket Costs” shall mean costs and expenses paid to Third Parties (or payable
to Third Parties and accrued in accordance with GAAP) by Regeneron (or its Affiliate) directly in
connection with the performance of the Discovery Program.

     1.57 ”Party” or “Parties” shall have the meaning set forth in the introductory paragraph.

     1.58 ”Patent Application” shall mean any application for a Patent.

     1.59 ”Patent Rights” shall mean unexpired Patents and Patent Applications.

     1.60 “Patents” shall mean patents together with all substitutions, divisions,
continuations, continuations-in-part, reissues, reexaminations, extensions, registrations, patent
term adjustments or extensions, supplemental protection certificates and renewals of any of the
foregoing, and all counterparts thereof in any country in the Territory.

     1.61 “Person” shall mean and include an individual, partnership, joint venture, limited
liability company, corporation, firm, trust, unincorporated organization and government or other
department or agency thereof.

     1.62 “Phase I Clinical Trial” shall mean the first clinical trial of a Product Candidate
following IND Preparation.

     1.63 “Product Candidate”
shall mean any Lead Candidate that substantially completes IND Preparation and is ready to be
offered for license to Sanofi under the Opt-In Rights.

     1.64 “Product Patent Rights” shall mean any Patent or Patent Application having a
specification which supports a claim that may be infringed by making, using, selling, importing or
exporting a Lead Candidate or Product Candidate in the Discovery Program, including, without
limitation, any derivatives, fragments, compositions of matter or uses, thereof.

7

 

     1.65 “Program Target” shall mean a Target that is selected by Regeneron, subject to
Section 2.4, as a Target against which Antibodies are to be generated under the Discovery
Program.

     1.66 “ Publishing Party” shall have the meaning set forth in Section 9.3.

     1.67 “ Receiving Party “shall have the meaning set forth in Section 9.1.

     1.68 “ Refused Candidate” shall have the meaning set forth in Section 5.6 (i).

     1.69 “Regeneron” shall have the meaning set forth in the introductory paragraph.

     1.70 “ Regeneron Indemnitees” shall have the meaning set forth in Section 10.1(a).

     1.71 “Regeneron Intellectual Property” shall mean the Regeneron Patent Rights and the
Regeneron Know-How.

     1.72 “Regeneron Know-How” shall mean any and all Know-How now or hereafter during the term
of the Discovery Program owned by, licensed to or otherwise held by Regeneron or any of its
Affiliates (other than Sanofi Know-How and Know-How included in Joint Inventions) with the right to
sublicense the same necessary or useful for the performance of the Discovery Program.

     1.73 “Regeneron Patent Rights”
shall mean those Patent Rights now or hereafter during the term of the Discovery Program owned
by, licensed to or otherwise held by Regeneron or any of its Affiliates (other than Sanofi Patent
Rights and Patent Rights included in Joint Inventions) with the right to sublicense the same and
which include at least one (1) claim which would be infringed by the research, development,
manufacture or use of the Mice or any Target, Antibody (including any MTC), Lead Candidate or
Product Candidate in the Discovery Program.

     1.74 “Regeneron Sole Inventions” shall have the meaning set forth in Section
6.1(a).

     1.75 “Regeneron Target IP” shall mean ****************************.

     1.76 “Regulatory Authority” shall mean any federal, national, multinational, state,
provincial or local regulatory agency, department, bureau or other governmental entity anywhere in
the world with authority over the activities conducted under the Discovery Program.

     1.77 “Royalty Product” shall mean **********************************.

     1.78 “ Royalty Term “shall have the meaning set forth in Section 4.5.

     1.79 “Sanofi “shall have the meaning set forth in the introductory paragraph.

     1.80 “ Sanofi Divested Antibody” shall have the meaning set forth in Section 2.8(b)(vii).

     1.81 “ Sanofi Indemnitees ” shall have the meaning set forth in Section 10.1(b).

8

 

     1.82 “Sanofi Intellectual Property” shall mean the Sanofi Patent Rights and the Sanofi
Know-How.

     1.83 “Sanofi Know-How” shall mean any and all Know-How now or hereafter during the term of
the Discovery Program (including the Tail Period) owned by, licensed to or otherwise held by Sanofi
or any of its
Affiliates (other than Regeneron Know-How and Know-How included in Joint Inventions) with the right
to sublicense the same necessary or useful for the performance of the Discovery Program.

     1.84 “Sanofi Patent Rights” shall mean those Patent Rights now or hereafter during the term
of the Discovery Program owned by, licensed to or otherwise held by Sanofi or any of its Affiliates
(other than Regeneron Patent Rights and Patent Rights included in Joint Inventions) with the right
to sublicense the same and which include at least one (1) claim which would be infringed by the
research, development, manufacture or use of the Mice or any Target, Antibody (including any MTC),
Lead Candidate or Product Candidate in the Discovery Program.

     1.85 “Sanofi Sole Inventions” shall have the meaning set forth in Section 6.1(a).

     1.86 “Sanofi Sole Projects” shall have the meaning set forth in Section 2.8(b)(iii).

     1.87 “Sanofi Targets” shall have the meaning set forth in Section 2.4.

     1.88 “Sanofi Target IP” shall mean *********************************.

     1.89 “Sole Inventions” shall have the meaning set forth in Section 6.1(a).

     1.90 “Solely Developed ****************.” shall have the meaning set forth in
Section 2.11(b).

     1.91 “Stock Purchase Agreement” shall mean the Stock Purchase dated as of the Effective
Date by and between (a) Sanofi, sanofi-aventis US LLC, and Sanofi-Aventis Amerique du Nord and (b)
Regeneron.

     1.92 “Tail Period” shall have the meaning set forth in Section 2.9.

     1.93 “Target”

shall mean any gene, receptor, ligand, or other molecule (a) potentially associated with a
disease activity, and (b) which potentially has a biological activity that is modified by direct
interaction with an Antibody, including any MTC, or (c) to which an Antibody, including any MTC,
binds.

     1.94 “Target List” shall mean the list of Targets in the Discovery Program, including a
description of the stage of discovery or pre-clinical development of each such Target in the
Discovery Program, which list shall be in the form attached as Schedule 1.94, and which list shall
be updated by the JRC on a quarterly basis in accordance with Section 3.1(c) below.

     1.95 “Term” shall have the meaning set forth in Section 12.1.

     1.96 “Territory” shall mean all the countries and territories of the world.

9

 

     1.97 “Third Party” shall mean any Person other than Sanofi or Regeneron or any Affiliate of
either Party.

     1.98 “Third Party Opportunities” shall have the meaning set forth in Section
2.8(a)(ii).

     1.99 “Valid Claim” shall mean a claim of an issued and unexpired Patent (including the term
of any patent term extension, supplemental protection certificate, renewal or other extension)
which has not been held unpatentable, invalid or unenforceable in a final decision of a court or
other Government Authority of competent jurisdiction from which no appeal may be or has been taken,
and which has not been admitted to be invalid or unenforceable through reissue, re-examination,
disclaimer or otherwise.

ARTICLE 2

DISCOVERY PROGRAM

     2.1 Discovery Program. The objective of the Parties during the Discovery Program is for
Regeneron to discover, identify and/or validate Targets from which to select Program Targets,
generate Antibodies, including MTCs, against such Program Targets (including Program Targets that
are Sanofi Targets) from which to select Lead Candidates, and develop them through IND Preparation
to offer to Sanofi for joint development and commercialization under the terms set forth herein and
in the License and Collaboration Agreement. During the first five (5) years of the Discovery
Program, Regeneron will use Commercially Reasonable Efforts (i) to discover, identify and
validate Targets and (ii) to select Program Targets for review and discussion by the JRC pursuant
to Section 3.1 herein. ****************************************. Regeneron will use
Commercially Reasonable Efforts to manufacture preclinical and clinical supplies of the Lead
Candidates and Product Candidates for the Discovery Program and the Phase 1 Clinical Trial. The
JRC will prioritize the Antibodies, including MTCs, to be further pursued as Lead Candidates, and
Regeneron will commence IND Preparation activities only for those Antibodies, including MTCs, that
meet the applicable criteria set forth in Schedule 1.42. The JRC will evaluate, select and
prioritize Targets for the Target List. However, Regeneron will have the right to conduct Target
discovery and validation on Targets as part of the Discovery Program before they are formally
approved by the JRC for selection on the Target List but shall notify the JRC of any new Target at
the next meeting of the JRC. Subject to Sanofi’s selection rights under Section 3.1(e) and
the other terms of this Agreement, Regeneron will have sole responsibility for the design and
conduct of all activities under the Discovery Program, including, without limitation, decisions
relating to initiation and termination of programs and activities, manufacturing activities, and
staffing and resource allocation between different programs and activities in the Discovery
Program. Sanofi, through the JRC, will provide consultation and advice to support Regeneron’s
efforts.

     2.2 Term of the Discovery Program. The Discovery Program shall commence on the Effective
Date and shall end on December 31, 2012 unless (a) terminated earlier in accordance with the
provisions of this Agreement or (b) extended by Sanofi for the Tail Period pursuant to the terms of
Section 2.9.

     2.3 Discovery Plans. Regeneron will prepare an annual research discovery and pre-clinical
development plan (the “Discovery Plan”) for the Discovery Program setting forth the

10

 

overall
strategy, plans, and estimated budget for the Discovery Program for the ensuing Contract Year,
which it will submit to the JRC for review and comment. For each Lead Candidate, the Discovery
Plan will include activities and a planned timeline for IND Preparation. Regeneron shall consider
in good faith comments on the Discovery Plan from Sanofi’s representatives on the JRC. Except for
the initial Discovery Plan (which will be provided to the JRC within sixty (60) days of the
Effective Date), Regeneron will present an updated Discovery Plan to the JRC at least two (2)
months prior to the end of each Contract Year.

     2.4 Sanofi Targets. In the event that at any time the JRC is unable to agree on the
Targets to include on the Target List, Sanofi will have the right to select and maintain in each
update to the Target List up to ************************ of the Targets included under the
following headings of the Target List: ******************************************. Neither
Regeneron nor Regeneron’s representatives on the JRC shall have the right to reject, replace, or
discriminate against such Sanofi Targets without the agreement of Sanofi’s representatives on the
JRC. Sanofi shall provide Regeneron’s representatives on the JRC with its proposed list of Targets
at least ten (10) Business Days before each JRC meeting for consideration by the JRC and, if
necessary, selection by Sanofi to make up its ********** of the Target List as described in this
Section 2.4.

     2.5 Commercially Reasonable Efforts; Compliance with Laws. During the term of the
Discovery Program, Regeneron will use Commercially Reasonable Efforts to discover and develop
Product Candidates to offer for license to Sanofi pursuant to the Opt-In Rights. Without limiting
the foregoing, Regeneron will use Commercially Reasonable Efforts to identify Lead Candidates and
complete IND Preparation for Lead Candidates in a timely manner during the term of the Discovery
Program. Each Party hereby covenants and agrees to comply with applicable Laws in performing
activities connected with the Discovery Program.

     2.6 Exchange of Information. Regeneron will share information with the JRC in a timely
manner concerning the progress of the Discovery Program consistent with Section 3.1(b).
Without limiting the foregoing, at least five (5) calendar days prior to each regular quarterly
meeting of the JRC, Regeneron will use its Commercially Reasonable Efforts to provide to Sanofi’s
representatives on the JRC a written report (in electronic form) summarizing the material
activities undertaken by Regeneron in connection with the Discovery Plan, including information
concerning new Targets proposed for the Target List, new Program Targets, new Lead Candidates and
new Product Candidates. In addition, Regeneron will provide Sanofi with proposed Targets for
inclusion on the updated Target List and Target proposed not to be pursued further under the
Discovery Program at least ten (10) Business Days prior to each regular quarterly meeting of the
JRC. Sanofi shall have the right to reasonably request and to receive in a timely manner
clarifications and answers to questions with respect to such reports and any other data or
information it reasonably requests with respect to the conduct of the Discovery Program.

     2.7 Further Assurances and Transaction Approvals. Upon the terms and subject to the
conditions hereof, each of the Parties will use Commercially Reasonable Efforts to (a) take, or
cause to be taken, all actions necessary, proper or advisable under applicable Laws or otherwise to
consummate and make effective the transactions contemplated by this Agreement, (b) obtain from the
requisite Governmental Authorities any consents, licenses, permits, waivers, approvals,

11

 

authorizations, or orders required to be obtained or made in connection with the
authorization,
execution, and delivery of this Agreement and the consummation of the transactions contemplated by
this Agreement, and (c) make all necessary filings, and thereafter make any other advisable
submissions, with respect to this Agreement and the transactions contemplated by this Agreement
required under applicable Laws. The Parties will cooperate with each other in connection with the
making of all such filings, including by providing copies of all such non-confidential documents to
the other Party and its advisors prior to the filing and, if requested, by accepting all reasonable
additions, deletions, or changes suggested in connection therewith. Each Party will furnish all
information required for any applicable or other filing to be made pursuant to the rules and
regulations of any applicable Laws in connection with the transactions contemplated by this
Agreement.

     2.8 Exclusive Discovery Program.

          (a) Exclusivity.

               (i) General. Subject to the other subparagraphs in this Section 2.8,
*****************************************************.

               (ii) Third Party Opportunities. Subject to the other sub-paragraphs in this
Section 2.8, as part of the Discovery Program, the Parties may evaluate new
Targets, Antibodies, and antibody technologies owned or controlled by Third Parties
(“Third Party Opportunities”) to determine whether such Targets, Antibodies or
antibody technologies should be licensed or acquired by the Parties for the Discovery
Program. Should a Party identify such a Third Party Opportunity that it is interested in
acquiring or licensing for inclusion in the Discovery Program, it shall notify the other
Party for consideration and discussion. If the Parties approve the inclusion of such Third
Party Opportunity in the Discovery Program, the Parties shall decide which Party will
license or otherwise acquire rights to the Third Party Opportunity and include the
applicable Target, Antibody or antibody technology, as the case may be, in the Discovery
Program. *****************************************************************.

          (b) Exclusions. Notwithstanding subsection (a) above, the following shall
apply:

               (i) Excluded Candidates. Regeneron (and its Affiliates) shall have the right
to develop and commercialize Excluded Candidates of Regeneron as listed in Schedule 1.19
either on its own or with Third Parties outside the Discovery Program without restriction
under this Agreement, and Sanofi (and its Affiliates) shall have the right to develop and
commercialize Excluded Candidates of Sanofi listed in paragraph A of Schedule 1.19 on its
own or with Third Parties outside the Discovery Program without restriction under this
Agreement. **************************************. For the avoidance of doubt, each Party
shall have the right to develop and commercialize Antibodies (including, in the case of
Regeneron, MTCs) against Targets of the other Party’s Excluded Candidates on its own or
with Third Parties outside the Discovery Program without restriction under this Agreement.

12

 

               (ii) Refused Candidates. Regeneron (and its Affiliates) shall have the right
to develop and commercialize Refused Candidates outside the Discovery Program as set forth
in Section 5.6 below, unless ********************************.

               (iii) Sanofi Sole Projects. Sanofi shall only be entitled to take a total of
up to ************************************ into development outside the Discovery Program,
such Antibodies being defined as the “Sanofi Sole Projects”. Sanofi Sole Projects may be
generated from either its internal research and/or its acquisition from Third Parties as
follows:

               (1) Antibodies. Sanofi and its Affiliates shall have the right to
develop and commercialize Antibodies outside the Discovery Program (including
Antibodies licensed or acquired from a Third Party or through the acquisition of a
Third Party that owns or controls an Antibody), provided that, such Antibodies are
not against Targets on the Target List. Sanofi shall notify Regeneron in writing of
the Target(s) for each such Antibody at the time
******************************************. Regeneron and its Affiliates shall have
the right to discover, develop and commercialize Antibodies (including MTCs) against
any such Target(s) without restriction under this Agreement outside the Discovery
Program and this Agreement; or

               (2) Targets. Sanofi shall be entitled to discover Targets that are not
on the Target List and to exclude from the Target List, Targets proposed by
Regeneron for the Target List, if such Targets
******************************************. In order to exclude such Targets,
Sanofi must provide written notice of such exclusion to Regeneron within sixty (60)
days after its receipt of the Regeneron proposal together with a signed certificate
from an officer of Sanofi Parent certifying that
***********************************************. Each Party and their respective
Affiliates shall have the right to discover, develop, and commercialize Antibodies
(including, in the case of Regeneron, MTCs) against any such Target outside the
Discovery Program without restriction under this Agreement.
*******************************************. Sanofi shall notify Regeneron’s
representatives on the JRC before initiating discovery efforts on a Target other
than a Sanofi Target to be included in the Discovery Program that was formerly on
the Target List (but is no longer on the Target List), to determine whether
Regeneron’s representatives on the JRC are interested in reinitiating discovery or
validation activities against such Target as part of the Discovery Program.

               (iv) Third Party Antibodies In Development. Sanofi and its Affiliates shall
have the right to develop and commercialize an acquired Antibody (whether such acquisition
is by direct acquisition, by license or through the acquisition of a Third Party that owns
or controls an Antibody(ies) (the “Acquired Antibody”) that at the time of
acquisition *************************************. Sanofi shall notify promptly Regeneron
of
such acquisition or license (including the identity of the Target) and may continue
the development of such Acquired Antibody and other Antibodies

13

 

against such Target without
restriction outside of the Discovery Program and this Agreement. In the event of such an
acquisition or license by Sanofi, the applicable Target shall no longer be a deemed a
Program Target and shall be removed from the Target List, and Sanofi shall no longer have
any rights to any Antibodies, including MTCs, against such Target under this Agreement.
Regeneron may continue to develop and commercialize (on its own or with one or more Third
Parties) any MTCs or other Antibodies against such Target and may practice and use any
Regeneron Intellectual Property, including, without limitation, the Mice, in connection
with such activities, without restriction outside the Discovery Program and this Agreement.
***************.

               (v) Company Acquisitions For clarification, where Sanofi or its Affiliates
acquire rights to an Acquired Antibody by the acquisition of a Third Party or part or the
whole of its business, Sanofi may as an alternative to any rights under Sections
2.8(b)(iii) and (iv) above, either include the applicable Target for the
Acquired Antibody on the Target List (either with Regeneron’s consent or as one of the
Sanofi Targets), or commit in writing to Regeneron to divest such Acquired Antibody (by
sale or license) within *********************.

               (vi) Regulatory Divestitures. In the event that Sanofi acquires rights to an
Acquired Antibody as a result of its acquisition of a Third Party and believes, based on
the reasonable advice of its outside legal counsel, that it is required by Law to divest
its interest in the Antibodies against such Target in the Discovery Program, then Sanofi
shall have the right to exclude such Target from the Discovery Program, and develop and
commercialize such Acquired Antibodies outside the Discovery Program and the terms of this
Agreement. Sanofi shall no longer have any rights to any Antibodies, including MTCs,
against such Target under this Agreement (“Sanofi Divested Antibodies”); however,
********************************************. Either Party shall have the right to develop
and commercialize Antibodies against the applicable Target(s) outside the Discovery Program
and the terms of this Agreement, and Regeneron shall have and retain exclusive rights to
any Antibodies, including MTCs, discovered in the Discovery Program against such Target
without restrictions under this Agreement.

               (vii) ************************************************.

               (viii) **************************************.

     2.9 Tail Period. At Sanofi’s sole option, upon prior written notice to Regeneron, such
notice to be delivered no later than June 30, 2012 (**************************) (as applicable, the
“Tail Period Notice Date”), the term of the Discovery Program may be extended for up to
three (3) additional years (as designated by Sanofi
in its notice) (the “Tail Period”). If Sanofi fails to provide such written notice by the
applicable Tail Period Notice Date, the Discovery Program shall expire on December 31, 2012
(***********************). Sanofi

14

 

shall identify in its written notice the specific Program
Targets, Lead Candidates, and Product Candidates to be included in the Discovery Program during the
Tail Period. Within ninety (90) days of receipt of Sanofi’s notice, the Parties shall agree on a
plan and budget (which shall be on a cost basis) to perform the activities set forth below and as
requested by Sanofi to be carried out for each Contract Year of the Tail Period. In the event the
Parties do not agree on the commercial reasonableness of such budget, then such dispute shall be
referred to binding arbitration pursuant to the provisions of Article 13. During the Tail Period,
Regeneron will use Commercially Reasonable Efforts **************************************.

     2.10 Research Licenses; Licenses Generally. Each Party hereby grants to the other Party
and its Affiliates a non-exclusive, non-transferable, worldwide, royalty-free, research license,
without the right to sublicense, under the Regeneron Intellectual Property and the Sanofi
Intellectual Property, respectively, solely to perform the Discovery Program. For the avoidance of
doubt, neither Party shall use the licenses granted in this Section 2.10 for the benefit,
directly or indirectly, of any Third Party. Except as expressly provided for herein, nothing in
this Agreement grants 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). Except as expressly
provided for in this Section 2.10 or elsewhere in this Agreement, neither Party will be
deemed by this Agreement to have been granted any license or other rights to the other Party’s
Patent Rights or Know-How, either expressly or by implication, estoppel or otherwise. Upon
expiration or earlier termination of the Discovery Program, the licenses granted in Section
2.10 herein shall automatically terminate.

     2.11
Immunoconjugates. ******************************************.

     2.12 Sanofi Target Licenses. With respect to any Product Candidate against a Sanofi Target
that becomes a Refused Candidate (“Licensed Refused Sanofi Candidate”) or any Sanofi
Divested Antibody, Sanofi hereby grants to Regeneron a non-transferable, non-exclusive, worldwide,
royalty-bearing (in accordance with Section 4.4 herein) license, with the right to
sublicense, under the Sanofi Target IP solely to make, have made, use, sell, offer to sell and
import such Licensed Refused Sanofi Candidate or Sanofi Divested Antibody, as the case may be.

Where such Licensed Refused Sanofi Candidate is an Immunoconjugate, then
*****************************.

     2.13 Non-Exclusive License to Sanofi. Regeneron hereby grants Sanofi and its Affiliates a
worldwide, non-exclusive, non-transferable, royalty-free license, without the right to sublicense,
under Regeneron Intellectual Property discovered directly in connection with the performance of the
Discovery Program claiming Targets on the Target List and/or methods of use related to the
inhibition or use of such Targets for use by Sanofi and its Affiliates in connection with the
manufacture, use, sale, offer to sell, and import of small molecule drug and diagnostic products.

     2.14 Invention Assignment. All of the employees, officers and consultants of each Party
that are supporting the performance of its obligations under this Agreement shall have executed
agreements or have existing obligations under law requiring, in the case of employees

15

 

and officers,
assignment to such Party of all inventions made during the course of and as the result of their
association with such Party and, in the case of employees, officers and consultants, obligating the
individual to maintain as confidential such Party’s Confidential Information which such Party may
receive, to the extent required to support such Party’s obligations under this Agreement.

     2.15 Supply of VelociGeneÒ Mice. Within ninety (90) days of the Effective Date or as
otherwise mutually agreed by the Parties in writing, the Parties shall enter into a “Mouse Purchase
Agreement” pursuant to which Regeneron will use its proprietary technology for the production of
genetically modified mouse embryonic stem cell lines and mice derived from the corresponding mouse
stem cell lines for Sanofi. The commercial terms of the “Mouse Purchase Agreement” are outlined in
Exhibit B.

     2.16 Option for VelocImmuneÒ License. At Sanofi’s request within sixty (60) days of
the fifth anniversary of the Effective Date (or the third anniversary of the Effective Date in the
event that Sanofi terminates this Agreement in accordance with Section 12.4), the Parties
shall enter into a License and Material Transfer Agreement (the “License and MTA”) under
which Regeneron will license VelocImmune to Sanofi. ***********************************. As used
in this Section 2.16, VelocImmune shall mean Regeneron’s Mice technology as previously
licensed by Regeneron to Third Parties as of the Effective Date. The License and MTA shall contain
such other customary terms and conditions consistent with those included in Regeneron’s VelocImmune
license agreements existing as of the Effective Date.

     2.17 Option for *********************Licenses. To the extent that Regeneron decides to
license either its *************************technologies or other Antibody Know How (any such
technologies and Know How being licensed by Regeneron, being referred to as the “Additional
Technologies) to commercial entities, then at Sanofi’s request, at any time between the fifth
anniversary of the Effective Date (************************************) and one hundred eighty
(180) days following the expiration or earlier termination of the Discovery Program, the Parties
shall enter into a definitive agreement under which Regeneron will license the applicable
Additional Technologies to Sanofi. The definitive agreement(s) for the Additional Technologies to
be licensed to Sanofi shall contain commercial and other terms and conditions that are not
materially less favorable, when taken as a whole, than those included in any then-existing license
agreements with Third Parties for such Additional Technologies, if any.

     2.18 Third Party Platform Licenses. ********************************.

ARTICLE 3

JOINT RESEARCH COMMITTEE

     3.1 The Joint Research Committee.

          (a) Formation, Composition and Membership. Within thirty (30) days after the
Effective Date, the Parties will establish the JRC, which shall consist of at least three (3)
senior representatives appointed by each of Regeneron and Sanofi. Each Party may replace its
Committee members upon written notice to the other Party; provided that such replacement is
of

16

 

comparable standing and authority within that Party’s organization as the person he or she is
replacing (or is otherwise reasonably acceptable to the other Party). The JRC will have two (2)
co-chairpersons, one designated by each of Regeneron and Sanofi.

          (b) Meetings of the JRC. The JRC shall hold an initial joint meeting within
forty-five (45) days of the Effective Date or as otherwise agreed by the Parties. Thereafter, the
JRC shall meet at least once every calendar quarter, unless the JRC co-chairpersons otherwise
agree. All JRC meetings may be conducted by telephone, video-conference or in person as determined
by the JRC co-chairpersons; provided, however, that the JRC shall meet in person at
least once each calendar year, unless the Parties mutually agree to meet by alternative means.
Unless otherwise agreed by the Parties, all in-person meetings for JRC shall be held on an
alternating basis between Regeneron’s facilities and Sanofi’s facilities. Further, each
co-chairperson shall be entitled to call meetings in addition to the regularly scheduled quarterly
meetings. The co-chairpersons, with the assistance of the Alliance Managers, shall coordinate
activities to prepare and circulate an agenda in advance of each meeting and prepare and issue
draft minutes of each meeting within fourteen (14) days thereafter and final minutes within thirty
(30) days thereafter, such final minutes to include the updated Target List. With the consent of
the Parties (not to be unreasonably withheld or delayed), a reasonable number of other
representatives of a Party may attend any JRC meeting as non-voting observers (provided
that such additional representatives are under obligations of confidentiality and non-use
applicable to the Confidential Information of the other Party that are at least as stringent as
those set forth in Article 9 below). Each Party shall be responsible for all of its own
personnel and travel costs and expenses relating to participation in JRC meetings.

          (c) Duties. The JRC shall:

               (i) discuss the objectives of the Discovery Program;

               (ii) review and comment on the Discovery Plan;

               (iii) exchange and review scientific information and data relating to the activities
being conducted under, and the then-current progress of, the Discovery Program, including
the exchange and review of data and other information resulting from the Discovery Program,
and establish processes for the exchange of information relating to the progress of the
Discovery Program;

               (iv) discuss experiments believed by a Party’s representatives on the JRC to be
necessary to properly evaluate Program Targets, Lead Candidates and Product Candidates;

               (v) provide assistance and recommendations on the direction of the Discovery Program;

               (vi) evaluate, select and prioritize Targets proposed by each Party for inclusion on
the initial Target List and all quarterly updates thereto (subject to Section 2.4,
which updates shall conform to the format of the Target List;

17

 

               (vii) discuss whether an Antibody, including any MTC, satisfies the criteria of Lead
Candidates attached in Schedule 1.42;

               (viii) review and prioritize Lead Candidates;

               (ix) consider and act upon such other matters as specified in this Agreement or as
otherwise agreed to by the Parties;

               (x) make any such decisions as are expressly allocated to the JRC under this
Agreement; and

At the request of either Party’s representatives to the JRC, conduct ad hoc meetings in addition to
the quarterly meetings of the JRC as reasonably necessary to coordinate and expedite all decisions
made by the JRC.

          (d) Decision Making. The JRC shall operate by consensus. The representatives of each
Party shall have collectively one (1) vote on behalf of such Party; provided that no such
vote taken at a meeting shall be valid unless a representative of each Party is present and
participating in the vote. Notwithstanding the foregoing, each Party, in its sole discretion, by
written notice to the other Party, may choose not to have representatives on the JRC and leave
decisions of the JRC to representatives of the other Party.

     3.2 Alliance Management. Each of Sanofi and Regeneron shall appoint a senior
representative who possesses a general understanding of research, clinical, and regulatory issues
to act as its Alliance Manager (“Alliance Manager”). Each Alliance Manager shall be
charged with creating and maintaining a collaborative work environment between the Parties. Each
Alliance Manager will also be responsible for providing single-point communication for seeking
consensus both internally within the respective Party’s organization and with the other Party’s
organization, including facilitating review of external corporate communications.

     3.3 Resolution of Governance Matters.

          (a) Generally. The Parties shall cause their respective representatives on the JRC to
use their Commercially Reasonable Efforts to resolve all matters presented to them as expeditiously
as possible.

          (b) Executive Officers’ Resolution of Disputes. In the event that the JRC is, after a
period of thirty (30) days from the date a matter is submitted to it for decision, unable to make a
decision due to a lack of required unanimity, or the Parties are unable to agree on the budget for
the Initial Development Plan for a Product Candidate in accordance with Section 5.3 below,
either Party may require that the matter be submitted to the Executive Officers for a joint
decision. In such event, the co-chairpersons of the JRC, by written notice to each Party delivered
within five (5) days after receipt of the notice from a Party pursuant to the immediately
preceding sentence, shall formally request that the dispute be resolved by the Executive Officers,
specifying the nature of the dispute with sufficient specificity to permit adequate consideration
by such Executive Officers. The Executive Officers shall diligently and in good faith, attempt to
resolve the referred dispute within thirty (30) days of receiving such written notification or such

18

 

longer period of time as the Executive Officers may agree in writing. Regeneron’s Executive
Officer shall have the deciding vote over all matters referred to the Executive Officers by the
JRC, other than matters related to the commercial reasonableness of the budget for the Initial
Development Plan for a Product Candidate which shall be resolved in accordance with Section
13.1 below should the Executive Officers fail to resolve such matter.

     3.4 Obligations of the Parties and their Affiliates. The Parties shall cause their
respective designees on the JRC and their respective Executive Officers to take the actions and
make the decisions provided herein to be taken and made by such respective designees and Executive
Officers in the manner and within the applicable time periods provided herein.

ARTICLE 4

PAYMENTS

     4.1 Upfront Payment. Within five (5) Business Days of the Effective Date, Sanofi will pay
to Regeneron the non-refundable, non-creditable amount of US $85,000,000 (which will not be reduced
by any withholding or similar taxes) as consideration for access to Regeneron’s research
capabilities and suite of discovery technologies and the co-exclusive (with Regeneron) rights
granted to Sanofi hereunder during the term of the Discovery Program, including the Tail Period, if
any.

     4.2 Discovery Program Costs. Commencing on the Effective Date and continuing during the
term of the Discovery Program, Sanofi shall be responsible for paying one hundred percent (100%) of
all Discovery Program Costs, including Discovery Program Costs incurred for a Product Candidate
until the anticipated IND filing date for such Product Candidate, regardless of whether Sanofi
exercises its Opt-In Rights in accordance with Section 5.1; provided that, except
as set forth below, the total annual Discovery Program Costs to be paid by Sanofi in each of the
first five (5) years of the Discovery Program (the “Maximum Annual Discovery Program
Costs”) shall not exceed the following amounts (as calculated for each Contract Year):

	 	 	 
	Contract Year	 	Maximum Annual Discovery Program Costs
	1

	 	**********
	2

	 	*********
	3

	 	*********
	4

	 	*********
	5

	 	*********

In the event that the Discovery Program Costs incurred in any Contract Year are less than the
Maximum Annual Discovery Program Costs for such Contract Year, the amount of such shortfall up to
ten percent (10%) of the Maximum Annual Discovery Program Costs stated immediately above for each
Contract Year may be carried over to the ensuing Contract Year and added to the Maximum Annual
Discovery Program Costs for such ensuing Contract Year except for any such
shortfall at the end of Contract Year 5, such that Regeneron’s right to carry over any shortfall
shall not be applicable into or during the Tail Period. At least sixty (60) days prior to the end
of each Contract Year, Regeneron shall notify Sanofi if it reasonably believes that the total
Discovery Program Costs for such Contract Year will be less than the Maximum Annual

19

 

 Discovery
Program Costs for such Contract Year and whether Regeneron intends to apply such shortfall amount
to the Discovery Program Costs for the ensuing Contract Year.

To the extent that Sanofi performs any activities under the Discovery Program, it shall do so at
its sole cost and expense and such costs and expenses shall not be treated as Discovery Program
Costs for purposes of calculating the Maximum Annual Discovery Program Costs unless the JRC
expressly requests Sanofi to perform any such activities, in which case the mutually agreed upon
costs directly related to such activities shall be included in the calculation of the Maximum
Annual Discovery Program Costs. The Parties acknowledge that payments made by Sanofi pursuant to
this Section 4.2 are being made as research and development expenses, as defined in the
U.S. Internal Revenue Code Section 41, and agree that any and all credits or deductions to which
either party may be entitled on account of research performed pursuant to such payments shall be
allocated to Sanofi to the extent of such payments.

     4.3 Reports and Discovery Program Cost Payments. Within forty-five (45) days following the
end of each calendar quarter, Regeneron shall deliver electronically to Sanofi a written report
setting forth in reasonable detail the Discovery Program Costs incurred by Regeneron in such
calendar quarter along with an invoice therefore. Sanofi shall reimburse Regeneron for all
undisputed Discovery Program Costs set forth in each report within thirty (30) days after its
receipt thereof. Any disputed, unpaid Discovery Program Costs that are determined to be due and
payable to Regeneron under this Agreement shall be paid with the Default Interest Rate.

     4.4 Royalty Payments for Royalty Products(i) . If either Party, or its
Affiliate or licensee successfully develops and commercializes a Royalty Product, then the
commercializing Party shall pay to the non-commercializing Party, within sixty (60) days
following the end of each calendar quarter, the following royalties on the aggregate Net
Sales of such, respective Royalty Products during the Royalty Term:
*****************************.

In the event that any Royalty Product requires a sub-license to Sanofi Patent Rights or Regeneron
Patent Rights, as applicable, and such sub-license is granted under this Agreement, then any
financial remuneration that the licensing Party is required to pay to a Third Party for its license
from the Third Party shall be considered a pass-through cost to be borne by the Party developing
and/or commercializing the Royalty Product.

     4.5 Royalty Reporting. The royalties payable under Sections 4.4 (i),
4.4(iv), and 4.4(v) of this Agreement shall each be paid for the period of time,
as determined on a Royalty Product-by-Royalty Product and country-by-country basis, commencing on
the Effective Date and ending on the later to occur of (a) ************************ and, if
applicable, (b) the expiration of the last to expire Valid Claim of the Licensed Sanofi Target IP
or Regeneron Target IP, as the case may be. The royalties payable under Sections 4.4
(ii), 4.4 (iii), and 4.4(vi) of this Agreement shall each be paid on a Royalty
Product-by-Royalty Product and country-by-country
basis, commencing on the Effective Date and ending on the expiration of the last to expire Valid
Claim of the licensed Sanofi Target IP (the applicable period of time during which royalties are
payable pursuant to this sentence and the preceding sentence being referred to as the applicable
“Royalty Term”). During the applicable Royalty Term, the Party owing royalties shall
deliver to

20

 

the other Party with each royalty payment a report detailing in reasonable detail the
information necessary to calculate the royalty payments due under this Agreement for such calendar
quarter, including the following information, specified on a Royalty Product-by-Royalty Product and
country-by-country basis: (a) total gross invoiced amount from sales of each Royalty Product by a
Party, its Affiliates and sublicensees; (b) all relevant deductions from gross invoiced amounts to
calculate Net Sales; (c) Net Sales; and (d) royalties payable.

     4.6 Payment Method and Currency. All payments under this Agreement shall be made by bank
wire transfer in immediately available funds to an account designated by the Party to which such
payments are due. All sums due under this Agreement shall be payable in United States Dollars. In
those cases where the amount due in United States Dollars is calculated based upon one or more
currencies other than United States Dollars, such amounts shall be converted to United States
Dollars using the average of the buying and selling exchange rate for conversion of the applicable
foreign currency into United States Dollars, using the spot rates (the “Closing Mid-Point Rates”
found in the “Dollar spot forward against the Dollar” table published by The Financial Times, or
any other publication as agreed to by the Parties) from the last Business Day of the preceding
month.

     4.7 Late Payments. All late payments made under this Agreement (including payments made
pursuant to Sections 4.4 and 4.5 above), shall earn interest, to the extent
permitted by applicable Law, from the date due until paid at a rate equal to the thirty (30) day
London Inter-Bank Offering Rate (LIBOR) U.S. Dollars, as quoted in The Wall Street Journal (U.S.,
Eastern Edition) effective for the date on which the payment was due ***************** (such sum
being referred to as the “Default Interest Rate”).

     4.8 Taxes. Except as set forth in Section 4.1, any withholding or other taxes that
a Party is required by Law to withhold or pay on behalf of the other Party, with respect to any
payments to such other Party hereunder, shall be deducted from such payments and paid to the
appropriate tax authority contemporaneously with the remittance to such other Party;
provided, however, that the remitting Party shall furnish the other Party with
proper evidence, including any self-reporting documentation, of the taxes so paid. Each Party
shall cooperate with the other and furnish the other Party with appropriate documents to secure
application of the most favorable rate of withholding tax under applicable Law (or exemption from
such withholding tax payments, as applicable).

ARTICLE 5

OPT-IN RIGHTS TO LICENSE PRODUCT CANDIDATES

     5.1 Opt-In Rights to License Product Candidates. Subject to the last sentence of this
Section 5.1 and the other terms of this Agreement, Sanofi shall have the exclusive right
during the term of the Discovery Program to elect to jointly (with Regeneron) develop and
commercialize each Product Candidate as set forth below, under the terms and conditions set forth
in the License and Collaboration Agreement (the “Opt-In Rights”).
While the Opt-In Rights are in effect with respect to an Antibody from the Discovery Program,
including a MTC in the Discovery Program, Regeneron will not grant to any Third Party rights to any
such Antibody. The Opt-In Rights will expire and Sanofi will no longer have any rights or licenses
to any Antibodies, including MTCs, under this Agreement upon the expiration or earlier

21

 

termination
of the Discovery Program. After the first five (5) years of the Discovery Program (or if the
Discovery Program is earlier terminated by Sanofi under the terms of Section 12.4), the
Opt-In Rights shall remain in effect during the Tail Period solely with respect to Lead Candidates
and other Antibodies and MTCs against any applicable Targets properly identified by Sanofi in its
notice to extend the Discovery Program through the Tail Period provided under Section 2.9.

     5.2 Process for Opt-In Rights. ***********************************.

     5.3 Initial Development Plan. Within thirty (30) days after Sanofi’s receipt of the Opt-In
Report, the Parties shall jointly commence, and thereafter as promptly as practicable complete,
preparation of a plan and budget for the planned development activities for such Product Candidate
through the completion of the Phase I Clinical Trial (the “Initial Development Plan”), the
final budget included in which shall be subject to Sanofi’s written approval, not to be
unreasonably withheld or delayed; provided, however, that (i) the Parties shall not
be required to continue or complete such preparation if the Opt-In Period for such Product
Candidate has expired without Sanofi having timely exercised its Opt-In Rights with respect thereto
or Sanofi shall have otherwise advised Regeneron in writing that it will not exercise its Opt-In
Rights with respect to such Product Candidate and (ii) if the Parties are unable to agree on a
final budget the matter shall first be referred to the Executive Officers in accordance with
Section 3.3(b) above, and if such Executive Officers are unable to resolve such matter, it
shall be submitted to binding arbitration to be conducted in accordance with Section 13.1
below. If Sanofi properly exercises its Opt-In Rights with respect to a Product Candidate, such
Product Candidate shall be developed in accordance with the Initial Development Plan until the
Parties agree to the “Global Development Plan” as such term is defined in the License and
Collaboration Agreement.

     5.4 Opt-In Exercise. Sanofi may exercise its Opt-In Rights under this Agreement and
license a Product Candidate under the License and Collaboration Agreement by delivering to
Regeneron a written notice of exercise in the form annexed hereto as Exhibit A (an
“Opt-In Notice”) on or before the later of (i) ******************************, (“the
“Opt-In Period”), *********************************************************.

     5.5 Dll4 and REGN-88. Sanofi exercised its Opt-In Rights to REGN-88 as of the Effective
Date and shall be deemed to have exercised its Opt-In Right with respect to Delta-like ligand-4
(Dll4) MTCs as of the Effective Date. For clarification, development of the Delta-like ligand-4
(Dll4) MTCs shall be conducted under this Agreement until such time as an IND is filed.

     5.6 Refused Candidates. If Sanofi does not provide Regeneron with an Opt-In Notice within
the Opt-In Period with respect to a particular Product Candidate, or Sanofi notifies Regeneron that
it will not exercise Opt-In Rights with respect to the Product Candidate, then the following shall
apply:

               (i) Refused Candidate. The Opt-In Rights shall expire with respect to that
Product Candidate (a “Refused Candidate”). All licenses granted in Section
2.10 shall automatically expire with respect to each Product Candidate upon such
Product Candidate becoming a Refused Candidate. Following such time as a Product Candidate
becomes a Refused Candidate, except as set forth below, the applicable Target

22

 

shall no
longer be deemed a Program Target and shall be removed from the Target List and Sanofi
shall no longer have any rights to any Antibodies, including MTCs, against such Target
under this Agreement. Sanofi shall have a one-time right within four (4) weeks of the date
a Product Candidate becomes a Refused Candidate to designate the Target for such Refused
Candidate as one of its Sanofi Targets.

               (ii) Regeneron Rights. Regeneron may continue to develop and commercialize (on
its own or with one or more Third Parties) any Refused Candidate without restriction
outside the Discovery Program and this Agreement, unless the Refused Candidate is a
Competing Refused Candidate, in which case, Section 2.8(b)(ii) shall apply. In
addition, unless Sanofi has exercised its right under Section 5.6(i) to designate the
applicable Target for a Refused Candidate as one of its Sanofi Targets, then Regeneron may
continue to develop and commercialize (on its own or with one or more Third Parties) any
MTCs or other Antibodies against such Target and may practice and use any Regeneron
Intellectual Property, including, without limitation, the Mice, in connection with such
activities. If Sanofi has designated the applicable Target for the Refused Candidate as a
Sanofi Target pursuant to Section 5.6(i), then all Antibodies (including MTCs)
against such Target that were generated under the Discovery Program other than the Refused
Candidate shall remain part of the Discovery Program.

               (iii) Sanofi Rights. Neither Sanofi nor its Affiliates, either directly or
through any Third Party, may develop or commercialize an Antibody that is against the
Target of a Refused Candidate **********************************.

ARTICLE 6

NEWLY CREATED INVENTIONS

     6.1 Ownership of Newly Created Intellectual Property.

          (a) Each Party shall exclusively own all intellectual property (including, without limitation,
Know-How, Patents and Patent Applications and copyrights) discovered, invented, authored or
otherwise created solely by such Party, its employees, agents and consultants under the Discovery
Program (“Sole Inventions”). Sole Inventions made solely by Sanofi, its employees, agents
and consultants are referred to herein as “Sanofi Sole Inventions.” Sole Inventions made
solely by Regeneron, its employees, agents and consultants are referred to herein as “Regeneron
Sole Inventions.” The Parties agree that nothing in this Agreement, and no use by a Party of
the other Party’s Intellectual Property pursuant to this Agreement, shall vest in a Party any
right, title or interest in or to the other Party’s Intellectual Property, other than the license
rights expressly granted hereunder.

          (b) The Parties shall jointly own all intellectual property (including, without limitation,
Know-How, Patents and Patent Applications and copyrights) discovered, invented, authored or
otherwise created under the Discovery Programs that is invented or authored jointly by an
individual or individuals having an obligation to assign such intellectual property to Sanofi (or
for which ownership vests in Sanofi by operation of law), on the one hand, and an individual or
individuals having an obligation to assign such intellectual property to Regeneron (or for

23

 

which
ownership vests in Regeneron by operation of law), on the other hand, on the basis of each Party
having an undivided interest in the whole (“Joint Inventions”).

          (c) Notwithstanding the foregoing in Section 6.1(b), (i) for purposes of determining
whether a patentable invention is a Sanofi Sole Invention, a Regeneron Sole Invention or a Joint
Invention, questions of inventorship shall be resolved in accordance with United States patent
laws, as determined, if necessary, by an independent third party, (ii) for purposes of determining
whether a copyrighted work is a Sanofi Sole Invention, a Regeneron Sole Invention or a Joint
Invention, questions of copyright authorship shall be resolved in accordance with United States
copyright laws, and (iii) for purposes of determining whether Know-How (other than copyrighted work
and Patent Applications) is a Sanofi Sole Invention, a Regeneron Sole Invention or a Joint
Invention, questions of authorship or inventorship shall be resolved in accordance with the laws of
the State of New York, United States.

          (d) To the extent that any right, title or interest in or to any intellectual property
discovered, invented, authored or otherwise created under this Agreement vests in a Party or its
Affiliate, by operation of Law or otherwise, in a manner contrary to the agreed upon ownership as
set forth in this Agreement, such Party (or its Affiliate) shall, and hereby does, irrevocably
assign to the other Party any and all such right, title and interest in and to such intellectual
property to the other Party without the need for any further action by any Party.

          (e) The Parties hereby agree that each Party’s use of the Joint Inventions shall be governed
by the terms and conditions of this Agreement including the following: each Party’s interest in
the Joint Inventions may be sublicensed to Third Parties, and any ownership rights therein
transferred, in whole or in part, by each Party without consent of the other Party (unless
otherwise prohibited by this Agreement or the License and Collaboration Agreement);
provided that (i) each of the Parties acknowledges that it receives no rights to any
Intellectual Property of the other Party underlying or necessary for the use of any Joint
Invention, except as otherwise set forth herein or in the License and Collaboration Agreement, (ii)
each Party agrees not to transfer any of its ownership interest in any of the Joint Inventions
without securing the transferee’s written agreement to be bound by the terms of this Section
6.1(e), (iii) during the Discovery Program, each Party agrees not to license its interest in
any Joint Invention with the right to use such Joint Invention for developing, manufacturing or
commercializing antibodies (except for developing, manufacturing or commercializing a Party’s
Antibodies that may be included in the exclusions described in Section 2.8 (b) of the
Agreement), and (iv) nothing in this Article 6 shall relieve a Party or its Affiliates of
their obligations under Article 9 with respect to Confidential Information provided by the
other Party or such other Party’s Affiliates. Neither Party hereto shall have the obligation to
account to the other Party for any revenues or profits obtained from any transfer of its interest
in, or its use, sublicense or other exploitation of, the Joint Inventions outside the scope of the
Discovery Program. Each of the Parties (or its Affiliate), as joint owner
of the Joint Inventions, agrees to cooperate with any enforcement actions brought by the other
joint owner(s) against any Third Parties, and further agrees not to grant any licenses to any such
Third Parties against which such enforcement actions are brought during the time of such dispute,
without the prior written consent of the other joint owner(s), such consent not to be unreasonably
withheld. The provisions governing Joint Inventions set forth in this Section 6.1(e) shall
survive the expiration or termination of this Agreement.

24

 

     6.2 Prosecution and Maintenance of Patent Rights.

          (a) Subject to the terms of the License and Collaboration Agreement with respect to Licensed
Products, Regeneron shall prepare, file, prosecute and maintain Patents and Patent Applications (as
applicable) included in the Regeneron Patent Rights and Regeneron shall confer with and keep Sanofi
reasonably informed regarding the status of such activities to the extent they are Product Patent
Rights. ********************************************.  

          (b) With respect to any Joint Patent Rights, the Parties shall consult with each other
regarding the filing, prosecution and maintenance of any Patents and Patent Applications, and
responsibility for such activities shall be the obligation of Regeneron.  Regeneron shall undertake
such filings, prosecutions and maintenance in the names of both Parties as co-owners
*********************************************************.  

          (c) The Parties shall have the following obligations with respect to the filing, prosecution
and maintenance of any Joint Patent Rights, as well as any Product Patent Rights:  (i) the
prosecuting Party (the “Prosecuting Party”) shall provide the other Party (the
“Non-Prosecuting Party”) with notice and a copy of a substantially completed draft of any
Patent Application at least thirty (30) days prior to the filing of any such Patent Application by
the Prosecuting Party and incorporate all reasonable comments provided by the Non-Prosecuting Party
within such thirty (30) day period unless the Prosecuting Party reasonably believes that such
comments will adversely affect the scope or validity of the Patent Application or resulting Patent
(it being understood that the Parties will discuss any points of disagreement and work to resolve
disagreements during this thirty (30) day period); (ii) the Prosecuting Party shall notify the
Non-Prosecuting Party prior to its filing of a Patent Application; (iii) the Prosecuting Party
shall consult with the Non-Prosecuting Party promptly following the filing of the Patent
Application to mutually determine in which countries it shall file convention Patent Applications;
(iv) the Prosecuting Party shall provide the Non-Prosecuting Party promptly with copies of all
material communications received from or filed in patent offices with respect to such applications
and incorporate all reasonable comments provided by the Non-Prosecuting Party, unless the
Prosecuting Party reasonably believes that such comments will adversely affect the validity or
scope of the Patent Application or resulting Patent for both Parties; and (v) the Prosecuting Party
shall provide the Non-Prosecuting Party a reasonable time prior to taking or failing to take action
that would affect the scope or validity of rights under any Patent Applications or Patents, but in
no event less than sixty (60) days prior to the next deadline for any action that may be taken with
the applicable patent office, (including but not limited to substantially narrowing or canceling
any claim without reserving the right to file a continuing or divisional Patent Application,
abandoning any Patent or not filing or perfecting the filing of any Patent Application in any
country), with notice of such proposed action or inaction so that the Non-Prosecuting Party has a
reasonable opportunity to review and
make comments, and take such actions as may be appropriate in the circumstances, including
assuming the Prosecuting Party’s responsibility for filing, prosecution and maintenance of any such
Product Patent Right or Joint Patent Right and becoming the Prosecuting Party. With respect to
Joint Inventions, it is understood that the Prosecuting Party and Non-Prosecuting Party shall use
all reasonable efforts to reach agreement on all material filings and amendments and no such
material filings or amendments shall be made by the Non-Prosecuting Party without the prior written
agreement of

25

 

the Non-Prosecuting Party, such agreement not to be unreasonably withheld or delayed.
In addition, in the event that the Prosecuting Party materially breaches the foregoing obligations
and such material breach is not cured within thirty (30) days of a written notice from the
Non-Prosecuting Party describing such breach in reasonable detail, or in the event that the
Prosecuting Party fails to undertake the filing of a Patent Application within the earlier of (i)
ninety (90) days of a written request by the Non-Prosecuting Party to do so, and (ii) sixty (60)
days prior to the anticipated filing date, the Non-Prosecuting Party may assume the Prosecuting
Party’s responsibility for filing, prosecution and maintenance of any such Product Patent Right and
will thereafter be deemed the Prosecuting Party for purposes hereof.  Notwithstanding the
foregoing, the Prosecuting Party may withdraw from or abandon any Patent or Patent Application on
thirty (30) days’ prior notice to the Non-Prosecuting Party (provided that such notice
shall be given no later than sixty (60) days prior to the next deadline for any action that may be
taken with respect to such Patent or Patent Application with the applicable patent office),
providing the Non-Prosecuting Party a free-of-charge option to assume the prosecution or
maintenance thereof. The Parties will file and prosecute Patent Applications described in this
Section 6.2(a) in the list of countries set forth in Exhibit C, unless otherwise
agreed upon by the Parties.

          (d) All costs incurred in the filing, prosecution and maintenance of any Joint Patent Rights
and Product Patent Rights and in performing freedom to operate analyses on Program Targets or Lead
Candidates shall be shared equally by the Parties.

     6.3 Third Party Claims. In the normal course of business, Regeneron shall carry out patent
searches in relation to the Program Targets, Lead Candidates, and Product Candidates, as well as
the technologies used to discover, develop and commercialize any of the foregoing, and will
disclose, along with any analysis, to Sanofi’s counsel any conflict or likely conflict of which
Regeneron is aware with respect to the Patent Rights of any Third Party with respect to any such
Program Targets, Lead Candidates and Product Candidates prior to selection to enter IND
Preparation.  If either Party or its Affiliates shall learn of a Third Party claim that the
activities under the Discovery Program infringe or otherwise violate the intellectual property
rights of any Third Party in the Territory, then such Party shall promptly notify the other Party
in writing of this claim, assertion or certification.  As soon as reasonably practical after the
receipt of such notice, the Parties shall cause their respective legal counsel to meet to confer on
such allegation of infringement. In particular, with regard to issues related to freedom to operate
concerning Targets pursued under this Agreement, the Parties shall conduct and maintain ongoing and
regular communications between their legal/intellectual property departments.

ARTICLE 7

BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS

     7.1 Books and Records. Each Party shall keep proper books of record and account in which
full, true and correct entries (in conformity with GAAP) shall be made for the purpose of
determining the amounts payable or owed pursuant to this Agreement. Each Party shall permit
auditors, as provided in Section 7.2, to visit and inspect, during regular business hours
and under the guidance of its employees, the books of record and account of such Party to the
extent relating to this Agreement and discuss its affairs, finances and accounts to the extent
relating to this Agreement.

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     7.2 Audits and Adjustments.

          (a) Each Party shall have the right, upon no less than thirty (30) days’ advance written
notice and at such reasonable times and intervals and to such reasonable extent as the Party shall
request, not more than once during any Contract Year, to have the books and records of the other
Party to the extent relating to this Agreement for the preceding two (2) years audited by an
independent “Big Four” (or equivalent) accounting firm of its choosing under reasonable,
appropriate confidentiality provisions, for the sole purpose of verifying the accuracy of all
financial, accounting and numerical information and calculations provided, and payments made, under
this Agreement; provided that no period may be subjected to audit more than one (1) time
unless a material discrepancy is found in any such audit of such period, in which case additional
audits of such period may be conducted until no material discrepancies are found.

          (b) The results of any such audit shall be delivered in writing to each Party and shall be
final and binding upon the Parties, unless disputed by a Party within ninety (90) days of delivery.
If a Party over billed or underpaid an amount due under this Agreement resulting in a cumulative
discrepancy during any year of more than ****************************, it shall also reimburse the
other Party for the costs of such audit (with the cost of the audit to be paid by the Party
initiating the audit in all other cases). Such accountants shall not reveal to the Party
requesting the audit the details of its review, except for the findings of such review and such
information as is required to be disclosed under this Agreement, and shall be subject to the
confidentiality provisions contained in Article 9.

          (c) If any examination or audit of the records described above discloses an over billing or
underpayment of amounts due hereunder, then unless the result of the audit is contested pursuant to
Section 7.2(b) above, the Party that overbilled or underpaid shall pay the same (plus
interest thereon at the Default Interest Rate from the date of such over billing or underpayment
through the date of payment of the amount required to be paid pursuant to this Section
7.2(c)) to the Party entitled thereto within thirty (30) days after receipt of the written
results of such audit pursuant to this Section 7.2.

          (d) Disputes. Any disputes with respect to the results of any audit conducted under
Section 7.2 above shall be resolved by binding arbitration in accordance with Section
13.1 below.

     7.3 IAS/IFRS/GAAP. Except as otherwise provided herein, all costs and expenses and other
financial determinations with respect to this Agreement shall be determined in accordance with
IAS/IFRS, and for the US, if desired, GAAP, as generally and consistently applied.

ARTICLE 8

REPRESENTATIONS, WARRANTIES AND COVENANTS

     8.1 Joint Representations and Warranties. Each Party hereto represents and warrants to the
other Party, as of the Effective Date, as follows: (a) it is duly organized and validly existing
under the Laws of its jurisdiction of incorporation; (b) it has full corporate power and authority
and has taken all corporate action necessary to enter into and perform this Agreement;

27

 

(c) the
execution and performance by it of its obligations hereunder will not constitute a breach of, or
conflict with, its organizational documents nor any other material agreement or arrangement,
whether written or oral, by which it is bound or requirement of applicable Laws or regulations; (d)
this Agreement is its legal, valid and binding obligation, enforceable in accordance with the terms
and conditions hereof (subject to applicable Laws of bankruptcy and moratorium); (e) such Party is
not prohibited by the terms of any agreement to which it is a party from performing the Discovery
Program or granting the rights and/or licenses hereunder; and (f) no broker, finder or investment
banker is entitled to any brokerage, finder’s or other fee in connection with this Agreement or the
transactions contemplated hereby based on arrangements made by it or on its behalf.

     8.2 Knowledge of Pending or Threatened Litigation. Each Party represents and warrants to
the other Party that, as of the Effective Date, there is no claim, announced investigation, suit,
action or proceeding pending or, to such Party’s knowledge, threatened, against such Party before
or by any court, arbitrator, or Governmental Authority that, individually or in the aggregate,
could reasonably be expected to (a) materially impair the ability of such Party to perform any of
its obligations under this Agreement or (b) prevent or materially delay or alter the consummation
of any or all of the transactions contemplated hereby. During the term of the Discovery Program,
each Party shall promptly notify the other Party in writing upon learning of any of the foregoing.

     8.3 Additional Regeneron Representations, Warranties and Covenants. Regeneron additionally
represents and warrants to Sanofi that, as of the Effective Date:

          (a) Regeneron owns or has a valid license to all Regeneron Patent Rights in existence as of
the Effective Date;

          (b) Regeneron has the right and authority to grant the rights (including the Opt-In Rights)
granted pursuant to the terms and conditions of this Agreement and Regeneron has not granted, and
will not grant during the term of this Agreement, any rights that would be inconsistent with or in
conflict with or in derogation of the rights granted herein;

          (c) there is no pending litigation of which Regeneron has received notice or is otherwise
aware that alleges that any of Regeneron’s activities relating to the Mice or the
Regeneron Intellectual Property have violated, or would violate, the intellectual property
rights of any Third Party (nor has it received any written communication threatening such
litigation);

          (d) to Regeneron’s knowledge, no litigation has been otherwise threatened which alleges that
any of its activities relating to the Mice or the Regeneron Intellectual Property have violated or
would violate, any intellectual property rights of any Third Party;

          (e) to Regeneron’s knowledge, after due inquiry, the use of the Mice and the Regeneron
Intellectual Property generally in the Discovery Program (but not with respect to a specific MTC or
Target) does not and will not infringe or otherwise violate any valid Patent or provisional rights
to applications or other intellectual property of any Third Party claiming genetically modified
mice or the use thereof to make antibodies;

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          (f) neither the development or reproduction of the Mice nor the conception, development and
reduction to practice of any Regeneron Intellectual Property existing as of the Effective Date has
constituted or involved the misappropriation of trade secrets or other rights of any Person;

          (g) to Regeneron’s knowledge, the issued Patents included in the Regeneron Intellectual
Property existing as of the Effective Date are not invalid or unenforceable, in whole or part;

          (h) Regeneron has not received any written notice of any threatened claims or litigation
seeking to invalidate or otherwise challenge the Regeneron Patent Rights or Regeneron’s rights
therein, and, to Regeneron’s knowledge, none of the Regeneron Patent Rights are subject to any
pending re-examination, opposition, interference or litigation proceedings;

          (i) The commercial terms of the “Mouse Purchase Agreement” referred to in Section 2.15
and as outlined in Exhibit B hereto are consistent with those contained in Regeneron’s
existing agreements with other commercial entities, and

          (j) neither Regeneron nor any of its Affiliates shall transfer ownership, assign ownership,
grant a security interest in or otherwise encumber any of its rights in, to or under any Regeneron
Intellectual Property in a way that will impair Sanofi’s rights or Regeneron ability to perform
its obligations under this Agreement.

***************************************************************.

     8.4 Disclaimer of Warranties. EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE,
CONCERNING THE SUCCESS OR POTENTIAL SUCCESS OF THE DEVELOPMENT, COMMERCIALIZATION, MARKETING OR
SALE OF ANY PRODUCT. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ANY AND
ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

ARTICLE 9

CONFIDENTIALITY

     9.1 Confidential Information. During the term of this Agreement and for a period of five
(5) years thereafter, each Party (in such capacity, the “Receiving Party”) shall keep
confidential, and other than as provided herein or in the License and Collaboration Agreement,
shall not use or disclose, directly or indirectly, any and all trade secrets or other proprietary
information, including, without limitation, any proprietary data, inventions, documents, ideas,
information, discoveries, or materials, owned, developed, or possessed by the other Party (in such
capacity, the “Disclosing Party”), whether in tangible or intangible form, the
confidentiality of which the Disclosing Party takes reasonable measures to protect, including but
not limited to Regeneron Know-How and Sanofi Know-How disclosed by the Disclosing Party under this

29

 

Agreement (the “Confidential Information”). For purposes of this Agreement, all
confidential information disclosed by Regeneron under the terms of the confidentiality agreements
between Sanofi Parent and Regeneron dated February 1, 2007 and October 23, 2007 is hereby deemed
Confidential Information of Regeneron. Each of Sanofi and Regeneron covenants that neither it nor
any of its respective Affiliates shall disclose any Confidential Information of the other Party to
any Third Party except to its employees, agents, consultants or any other Person under its
authorization; provided such employees, agents, consultants or other Persons are subject in
writing to confidentiality obligations applicable to the Disclosing Party’s Confidential
Information no less strict than those set forth herein.

          (a) Notwithstanding the foregoing, Confidential Information shall not be deemed to include
information and materials (and such information and materials shall not be considered Confidential
Information under this Agreement) to the extent that it can be established by written documentation
by the Receiving Party that such information or material is: (i) already in the public domain as of
the Effective Date or becomes publicly known through no act, omission or fault of the Receiving
Party or any Person to whom the Receiving Party provided such information; (ii) is or was already
in the possession of the Receiving Party at the time of disclosure by the Disclosing Party; (iii)
is disclosed to the Receiving Party on an unrestricted basis from a Third Party not under an
obligation of confidentiality to the Disclosing Party or any Affiliate of the Disclosing Party with
respect to such information; (iv) information that has been independently created by the Receiving
Party (or its Affiliate), as evidenced by written or electronic documentation, without any aid,
application or use of the Disclosing Party’s Confidential Information; or (v) required by Law to be
disclosed, provided that the Receiving Party uses reasonable efforts to give the disclosing
Party advance notice of such required disclosure in sufficient time to enable the Disclosing Party
to seek confidential treatment for such information, and provided further that the
Receiving Party provides all reasonable cooperation to assist the Disclosing Party to protect such
information and limits the disclosure to that information which is required by Law to be disclosed.

          (b) Information and other Know-How that is discovered by Regeneron in connection with the
Discovery Program will be considered Regeneron’s Confidential Information,
except to the extent it relates to a Licensed Product, in which case it shall be Confidential
Information of both Parties, subject to the terms of the License and Collaboration Agreement.

          (c) Specific aspects or details of Confidential Information will not be deemed to be within
the public knowledge or in the prior possession of a Person merely because such aspects or details
of the Confidential Information are embraced by general disclosures in the public domain. In
addition, any combination of Confidential Information will not be considered in the public
knowledge or in the prior possession of either Person merely because individual elements thereof
are in the public domain or in the prior possession of a Person unless (i) the combination and its
principles are in the public knowledge or in the prior possession of that Person and (ii) the
combination is documented, in a single contemporaneous document, as in the public knowledge or in
the prior possession of a Person.

          (d) Notwithstanding anything else in this Agreement to the contrary, each Party hereto (and
each employee, representative, or other agent of any Party) may disclose to any and all Persons,
without limitation of any kind, the Federal income tax treatment and Federal

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income tax structure
of any and all transaction(s) contemplated herein and all materials of any kind (including opinions
or other tax analyses) that are or have been provided to any Party (or to any employee,
representative, or other agent of any party) relating to such tax treatment or tax structure,
provided, however, that this authorization of disclosure shall not apply to
restrictions reasonably necessary to comply with securities laws. This authorization of disclosure
is retroactively effective immediately upon commencement of the first discussions regarding the
transactions contemplated herein, and the Parties aver and affirm that this tax disclosure
authorization has been given on a date which is no later than thirty (30) days from the first day
that any Party hereto (or any employee, representative, or other agent of any party hereto) first
made or provided a statement as to the potential tax consequences that may result from the
transactions contemplated hereby.

     9.2 Injunctive Relief. The Parties hereby acknowledge and agree that the rights of the
Parties hereunder are special, unique and of extraordinary character, and that if any Party refuses
or otherwise fails to act, or to cause its Affiliates to act, in accordance with the provisions of
this Agreement, such refusal or failure would result in irreparable injury to the other Party, the
exact amount of which would be difficult to ascertain or estimate and the remedies at law for which
would not be reasonable or adequate compensation. Accordingly, if any Party refuses or otherwise
fails to act, or to cause its Affiliates to act, in accordance with the provisions of this
Agreement, then, in addition to any other remedy which may be available to any damaged Party at law
or in equity, such damaged Party will be entitled to seek specific performance and injunctive
relief, without posting bond or other security, and without the necessity of proving actual or
threatened damages, which remedy such damaged party will be entitled to seek in any court of
competent jurisdiction.

     9.3 Publications. If either Sanofi or Regeneron (the “Publishing Party”) desires
to publish or publicly present any results from the Discovery Program in scientific journals,
publications or scientific presentations or otherwise, the Publishing Party shall provide the other
Party an advance final copy of any proposed publication or summary of a proposed oral presentation
relating to the information from the Discovery Program prior to submission for publication or
disclosure. Such other Party shall have a
reasonable opportunity to recommend any changes it reasonably believes are necessary to preserve
the confidentiality of its Confidential Information and to recommend any changes it reasonably
believes are necessary to prevent any specific, material adverse effect to it as a result of the
publication or disclosure, to which the Publishing Party shall give due consideration. If such
other Party informs the Publishing Party, within thirty (30) days of receipt (or such other period
agreed to by the JRC) of an advance copy of a proposed publication or summary of a proposed oral
presentation, that such publication in its reasonable judgment should not be published or
presented, the Publishing Party shall delay or prevent such disclosure or publication as proposed
by the other Party. In the case of patentable inventions, the delay shall be sufficiently long to
permit the timely preparation and filing of a patent application(s) or application(s) for a
certificate of invention on the information involved. The Parties shall establish a publication
review process to ensure compliance with this Section 9.3.

     9.4 Disclosures Concerning this Agreement. The Parties will mutually agree upon the
contents of a their respective press releases with respect to the execution of this Agreement and

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the License and Collaboration Agreement which shall be issued simultaneously by both Parties on the
Effective Date. Sanofi and Regeneron agree not to (and to ensure that their respective Affiliates
do not) issue any other press releases or public announcements concerning this Agreement or any
other activities contemplated hereunder without the prior written consent of the other Party (which
shall not be unreasonably withheld or delayed), except as required by a Governmental Authority or
applicable Law (including the rules and regulations of any stock exchange or trading market on
which a Party’s (or its parent entity’s) securities are traded); provided that the Party
intending to disclose such information shall use reasonable efforts to provide the other Party
advance notice of such required disclosure, an opportunity to review and comment on such proposed
disclosure (which comments shall be considered in good faith by the disclosing Party) and all
reasonable cooperation to assist the other Party to protect such information and shall limit the
disclosure to that information which is required to be disclosed. Notwithstanding the foregoing,
without prior submission to or approval of the other Party, either Party may issue press releases
or public announcements which incorporate information concerning this Agreement or any activities
contemplated hereunder which information was included in a press release or public disclosure which
was previously disclosed under the terms of this Agreement or which contains only non-material
factual information regarding this Agreement. Except as required by a Governmental Authority or
applicable Law (including the rules and regulations of any stock exchange or trading market on
which a Party’s (or its parent entity’s) securities are traded), or in connection with the
enforcement of this Agreement, neither Party (or their respective Affiliates) shall disclose to any
Third Party, under any circumstances, any financial terms of this Agreement that have not been
previously disclosed publicly pursuant to this Article 9 without the prior written consent
of the other Party, which consent shall not be unreasonably withheld or delayed; except for
disclosures to Third Parties that are bound by obligations of confidentiality and nonuse
substantially equivalent in scope to those included herein with a term of at least five (5) years.
Each Party acknowledges that the other Party as a publicly traded company is legally obligated to
make timely disclosures of all material events relating to its business. The Parties acknowledge
that either or both Parties may be obligated to file a copy of this Agreement with the United
States Securities and Exchange Commission or its equivalent in the Territory. Each Party will be
entitled to make such filing but shall cooperate with one another and use reasonable efforts to
obtain confidential treatment of confidential,
including trade secret, information in accordance with applicable Law. The filing Party will
provide the non-filing Party with an advance copy of the Agreement marked to show provisions for
which the filing Party intends to seek confidential treatment and will reasonably consider the
non-filing Party’s timely comments thereon.

ARTICLE 10

INDEMNITY

     10.1 Indemnity and Insurance.

          (a) Sanofi will defend, indemnify and hold harmless Regeneron, its Affiliates and their
respective officers, directors, employees and agents (“Regeneron Indemnitees”) from and
against all claims, demands, liabilities, damages, penalties, fines and expenses, including
reasonable attorneys’ fees and costs (collectively, “Damages”), arising from or occurring
as a

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result of a
Third Party’s claim, action, suit, judgment or settlement against a Regeneron
Indemnitee that is due to or based upon:

               (i) the negligence, recklessness, bad faith, intentional wrongful acts or omissions of
Sanofi or its Affiliates in connection with the Discovery Program, except to the extent
that Damages arise out of the negligence, recklessness, bad faith or intentional wrongful
acts, or omissions committed by Regeneron or its Affiliates; or

               (ii) material breach by Sanofi of the terms of, or the inaccuracy of any
representation or warranty made by it in, this Agreement.

          (b) Regeneron will defend, indemnify and hold harmless Sanofi, its Affiliates and their
respective officers, directors, employees and agents (“Sanofi Indemnitees”) from and
against all Damages arising from or occurring as a result of a Third Party’s claim, action, suit,
judgment or settlement against a Sanofi Indemnitee that is due to or based upon:

               (i) the negligence, recklessness, bad faith, intentional wrongful acts or omissions of
Regeneron or its Affiliates in connection with the Discovery Program, except to the extent
that Damages arise out of the negligence, recklessness, bad faith or intentional wrongful
acts, or omissions committed by Sanofi or its Affiliates; or

               (ii) material breach by Regeneron of the terms of, or the inaccuracy of any
representation or warranty made by it in, this Agreement.

     10.2 Indemnity Procedure.

          (a) The Party entitled to indemnification under this Article 10 (an “Indemnified
Party”) shall notify the Party potentially responsible for such indemnification (the
“Indemnifying Party”) within five (5) Business Days of becoming aware of any claim or
claims asserted or threatened in writing against the Indemnified Party which could give rise to a
right of indemnification under this Agreement; provided, however, that the failure
to give such notice shall not relieve the
Indemnifying Party of its indemnity obligation hereunder except to the extent that such
failure materially prejudices its rights hereunder.

               (i) If the Indemnifying Party has acknowledged in writing to the Indemnified Party the
Indemnifying Party’s responsibility for defending such claim, the Indemnifying Party shall
have the right to defend, at its sole cost and expense, such claim by all appropriate
proceedings, which proceedings shall be prosecuted diligently by the Indemnifying Party to
a final conclusion or settled at the discretion of the Indemnifying Party;
provided, however, that the Indemnifying Party may not enter into any
compromise or settlement unless (i) such compromise or settlement includes as an
unconditional term thereof, the giving by each claimant or plaintiff to the Indemnified
Party of a release from all liability in respect of such claim; and (ii) the Indemnified
Party consents to such compromise or settlement, which consent shall not be withheld or
delayed unless such compromise or settlement involves (A) any admission of legal wrongdoing
by the Indemnified Party, (B) any payment by the Indemnified Party that is not indemnified
hereunder or (C) the imposition of any equitable relief against the

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Indemnified Party. If
the Indemnifying Party does not elect to assume control of the defense of a claim or if a
good faith and diligent defense is not being or ceases to be materially conducted by the
Indemnifying Party, the Indemnified Party shall have the right, at the expense of the
Indemnifying Party, upon at least ten (10) Business Days’ prior written notice to the
Indemnifying Party of its intent to do so, to undertake the defense of such claim for the
account of the Indemnifying Party (with counsel reasonably selected by the Indemnified
Party and approved by the Indemnifying Party, such approval not unreasonably withheld or
delayed), provided, that the Indemnified Party shall keep the Indemnifying Party
apprised of all material developments with respect to such claim and promptly provide the
Indemnifying Party with copies of all correspondence and documents exchanged by the
Indemnified Party and the opposing party(ies) to such litigation. The Indemnified Party
may not compromise or settle such litigation without the prior written consent of the
Indemnifying Party, such consent not to be unreasonably withheld or delayed.

               (ii) The Indemnified Party may participate in, but not control, any defense or
settlement of any claim controlled by the Indemnifying Party pursuant to this Section
10.2 and shall bear its own costs and expenses with respect to such participation;
provided, however, that the Indemnifying Party shall bear such costs and
expenses if counsel for the Indemnifying Party shall have reasonably determined that such
counsel may not properly represent both the Indemnifying and the Indemnified Party.

               (iii) The amount of any Damages for which indemnification is provided under this
Article 10 will be reduced by the insurance proceeds received, and any other amount
recovered, if any, by the Indemnified Party in respect of any Damages.

               (iv) If an Indemnified Party receives an indemnification payment pursuant to this
Article 10 and subsequently receives insurance proceeds from its insurer with
respect to the damages in respect of which such indemnification
payment(s) was made, the Indemnified Party will promptly pay to the Indemnifying Party
an amount equal to the difference (if any) between (i) the sum of such insurance proceeds
or other amounts received, and the indemnification payment(s) received from the
Indemnifying Party pursuant to this Article 10 and (ii) the amount necessary to
fully and completely indemnify and hold harmless the Indemnified Party from and against
such Damages. However, in no event will such refund ever exceed the Indemnifying Party’s
indemnification payment(s) to the Indemnified Party under this Article 10.

ARTICLE 11

FORCE MAJEURE

     Neither Party will be held liable or responsible to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from causes beyond the
reasonable control of the affected Party including, without limitation, embargoes, acts of
terrorism, acts of war (whether war be declared or not), insurrections, strikes, riots, civil
commotions, or acts of God (“Force Majeure”). Such excuse from liability and
responsibility

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shall be effective only to the extent and duration of the event(s) causing the
failure or delay in performance and provided that the affected party has not caused such
event(s) to occur. The affected Party will notify the other Party of such Force Majeure
circumstances as soon as reasonably practical and will make every reasonable effort to mitigate the
effects of such Force Majeure circumstances.

ARTICLE 12

TERM AND TERMINATION

     12.1 Term.
The “Term” of this Agreement shall commence on the Effective Date and end on the later
to occur of (a) the expiration or earlier termination of the Discovery Program, including any Tail
Period, unless this Agreement is earlier terminated in accordance with this Article 12 in
which event the Term shall end on the effective date of such termination.

     12.2 Termination For Material Breach. Upon and subject to the terms and conditions of this Section 12.2, this Agreement shall
be terminable by a Party in its entirety if the other Party commits a material breach of this
Agreement. Such notice of termination shall set forth in reasonable detail the facts underlying or
constituting the alleged breach (and specifically referencing the provisions of this Agreement
alleged to have been breached), and the termination which is the subject of such notice shall be
effective ninety (90) days after the date such notice is given unless the breaching Party shall
have cured such breach within such ninety (90) day period. Notwithstanding the foregoing, in the
case of breach of a payment obligation not subject to a bona fide dispute hereunder, the ninety
(90) day period referred to in the immediately preceding sentence shall instead be forty-five (45)
days. For purposes of this Section 12.2, the term “material breach” shall mean an
intentional, continuing (and uncured within the time period described above), material breach by a
Party as
determined by binding arbitration consistent with the provisions of Section 13.1 of this
Agreement.

     12.3 Termination for Insolvency. Either Party shall have the right to terminate this Agreement in its entirety if, at any time,
(a) the other Party shall file in any court or agency pursuant to any statute or regulation of any
state or country, a petition in bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of the Party or of its assets, or (b)
if the other Party proposes a written agreement of composition or extension of its debts, or (c) if
the other Party shall be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days after the filing
thereof, or (d) if the other Party shall propose or be a party to any dissolution or liquidation,
or (e) if the other Party shall make an assignment for the benefit of creditors. In the event that
this Agreement is terminated or rejected by a Party or its receiver or trustee under applicable
bankruptcy Laws due to such Party’s bankruptcy, then all rights and licenses granted under or
pursuant to this Agreement by such Party to the other Party are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and any similar Laws in any other
country in the Territory, licenses of rights to “intellectual property” as defined under Section
101(52) of the U.S. Bankruptcy Code. The Parties agree that all intellectual property rights
licensed hereunder, including, without limitation, any Patent Rights in any country of a Party
covered by the license grants under this Agreement, are part of the “intellectual property” as
defined under Section 101(52) of the Bankruptcy Code subject to

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the protections afforded the
non-terminating Party under Section 365(n) of the Bankruptcy Code, and any similar law or
regulation in any other country.

     12.4 Termination by Sanofi on Notice. *************************************.

     12.5 Termination for Breach of Standstill. Regeneron shall have the unilateral right to terminate this Agreement in its entirety, effective
immediately upon written notice to Sanofi, if Sanofi or any of its Affiliates shall have breached
their obligations under any of Sections 3, 4 or 5 of the Investor Agreement (to the extent such
sections of the Investor Agreement is then in effect). Furthermore, Regeneron shall have the
unilateral right to terminate this Agreement in its entirety, effective immediately upon written
notice to Sanofi, if Sanofi or any of its Affiliates shall have (a) breached their obligations
under Section 20.16 of the Aventis Collaboration Agreement, to the extent that such Section 20.16
remains in effect after the Effective Date, or (b) breached its obligations under Section 5.3 of
the Stock Purchase Agreement, dated as of September 5, 2003, by and between Sanofi and Regeneron
(the “Aventis Stock Purchase Agreement”), to the extent that such Section 5.3 remains in
effect after the Effective Date. Any such breach of the Investor Agreement, the Aventis Stock
Purchase Agreement or the Aventis Collaboration Agreement, as the case may be, shall be treated as
a breach of this Agreement. Notwithstanding the foregoing and for the avoidance of doubt,
Regeneron shall not have the right to terminate this Agreement as a result of (i) a de minimus
breach of Section 3.1(a) of the
Investor Agreement (to the extent such Section 3.1(a) is in effect after the Effective Date) or of
Section 20.16(a) of the Aventis Collaboration Agreement (to the extent such Section 20.16(a)
remains in effect after the Effective Date) or (ii) an inadvertent breach of Section 3.1(g) of the
Investor Agreement (to the extent such Section 3.1(g) is in effect after the Effective Date) or an
inadvertent breach of Section 20.16(g) of the Aventis Collaboration Agreement (to the extent such
Section 20.16(g) remains in effect after the Effective Date), arising from informal discussions
covering general corporate or other business matters the purpose of which is not intended to
effectuate or lead to any of the actions referred to in paragraphs (a) through (e) of such Section
20.16 or of paragraphs (a) through (e) of Section 3.1 of the Investor Agreement, as applicable.
Sanofi’s rights under Sections 2.16 and 2.17 shall survive termination for breach
of the standstill or lock-up under Section 12.5 of the Agreement

     12.6 Termination for Breach of License and Collaboration Agreement. Notwithstanding anything to the contrary herein, (a) Regeneron shall have the unilateral right
to terminate this Agreement in its entirety, effective immediately upon providing written notice to
Sanofi, if Regeneron has terminated the License and Collaboration Agreement, in its entirety,
pursuant to Section 19.3, 19.4, or 19.5 of the License and Collaboration Agreement, and (b) Sanofi
shall have the unilateral right to terminate this Agreement in its entirety, effective immediately
upon providing written notice to Regeneron, if Sanofi has terminated the License and Collaboration
Agreement, in its entirety, pursuant to Section 19.3 or 19.4 of the License and Collaboration
Agreement.

     12.7  Effect of Termination by Sanofi for Breach. In addition to the provisions of Section 12.9 below, notwithstanding anything herein to
the contrary, in the event that Sanofi terminates this Agreement pursuant to Section 12.2
of this Agreement the following shall apply:

36

 

          (a) Sanofi shall be granted a non-exclusive, non-transferable, royalty free, worldwide
license, without the right to sublicense, for a period that shall expire six (6) years from the
Effective Date, to the Mice and the underlying Regeneron Intellectual Property for Sanofi and its
Affiliates to use to discover and develop MTCs for any and all purposes;

          (b) Regeneron shall perform a timely and expeditious technology transfer as required by Sanofi
to pursue its rights under subsection (a) without delay above subject to the execution of a
material transfer agreement containing non-financial terms and conditions related to the use of the
Mice consistent with Regeneron’s commercial license agreements for the Mice;

          (c) the licenses granted to Regeneron under this Agreement shall automatically terminate;

          (d) Sanofi shall be granted an exclusive, fully paid-up, non-transferable, royalty-free,
worldwide license, with the right to sublicense, under Regeneron Target IP existing at the
effective time of termination solely for use to develop and commercialize Antibodies against Sanofi
Discovery Targets (and for no other uses), and the co-exclusive (with Regeneron and its Affiliates)
fully paid-up, non-transferable, royalty-free, worldwide license, with the right
to sublicense under Regeneron Target IP to develop and commercialize Antibodies against all
other Program Targets at the time of termination (and for no other uses); and

          (e) Sanofi’s rights under Sections 2.15, 2.16 and 2.17 shall survive;
and

          (f) Sanofi shall have no further funding obligations under Section 4.2 of the
Agreement.

     12.8 Effect of Termination by Regeneron for Breach. In addition to the provisions of Sections 12.9 and 12.11 below, notwithstanding anything
herein to the contrary, in the event that Regeneron terminates this Agreement pursuant to
Section 12.2 or 12.5 of this Agreement, the following shall apply:

          (a) the licenses granted to Sanofi under this Agreement shall automatically terminate;

          (b) the rights granted to Sanofi under this Agreement in Sections 2.15, 2.16,
and 2.17 and Article 5 shall automatically terminate;

          (c) Regeneron shall be granted an exclusive, fully paid-up, non-transferable, royalty-free,
worldwide, exclusive license, with the right to sublicense, under Sanofi Target IP existing at the
effective time of termination solely for use to develop and commercialize Antibodies against
Program Targets other than Sanofi Discovery Targets (and for no other uses), and the co-exclusive
(with Sanofi and its Affiliates) fully paid-up, non-transferable, royalty-free, worldwide license,
with the right to sublicense under Sanofi Target IP to develop and commercialize Antibodies against
all Sanofi Discovery Targets at the time of termination (and for no other uses).

37

 

     12.9 Survival of Obligations. Subject to Sections 12.7 and 12.8 above and except as otherwise provided below,
upon expiration or termination of this Agreement, the rights and obligations of the Parties
hereunder shall terminate, and this Agreement shall cease to be of further force or effect,
provided that notwithstanding any expiration or termination of this Agreement:

          (a) neither Sanofi nor Regeneron shall be relieved of any obligations (including payment
obligations) of such Party arising prior to such expiration or termination, including, without
limitation, the payment of any non-cancelable costs and expenses incurred as part of the Discovery
Program (even if such costs and expenses arise following termination or expiration, as the case may
be); provided, however, that Sanofi shall not be obligated to pay or reimburse
Regeneron for any such costs or expenses in the event Sanofi terminates this Agreement pursuant to
Section 12.2  above (and with respect to 12.4, Sanofi shall have no further obligations to
pay for costs and expenses beyond the effective date of its termination notice);

          (b) the obligations of the Parties with respect to the protection and nondisclosure of the
other Party’s Confidential Information in accordance with Article 9, as well
as other provisions (including, without limitation, Sections 2.11(b), 2.11(c),
2.12 (except as set forth in Section 12.8 above), 2.13 (except as set forth
in Section 12.8 above), 2.16, 2.17, 6.1(e), 6.2(b), 6.2(c),
6.2(d)(as it relates to Joint Patent Rights), 7.2, 10.1, 10.2, this
Article 12, and Article 13) which by their nature are intended to survive any such
expiration or termination, shall survive and continue to be enforceable;

          (c) for the avoidance of doubt, the early termination of this Agreement by either Party, and
the expiration of this Agreement shall not relieve either Party of any of its royalty or other
obligations under Article 4 with respect to any Royalty Product, for which royalties
remain payable to the other Party under this Agreement; and such royalty provisions of Article 4
shall survive;

          (d) for the avoidance of doubt, the obligations of the Parties with respect to the licenses
granted in Sections 2.10, 2.11 (b), 2.11(c), 2.12, 2.13
shall survive the termination or expiration of this Agreement; and

          (e) such expiration or termination and this Article 12 shall be without prejudice to
any rights or remedies a Party may have for breach of this Agreement.

     12.10 Return of Confidential Information. Subject to either Parties’ licenses that survive termination or expiration, Confidential
Information disclosed by the Disclosing Party, including permitted copies, shall remain the
property of the Disclosing Party. Subject to the terms of the License and Collaboration Agreement
(with respect to Licensed Products), upon the earlier to occur of (a) the termination of this
Agreement or (b) the expiration of the Discovery Program, or upon written request of the Disclosing
Party, the Receiving Party shall promptly return to the Disclosing Party or, at the Disclosing
Party’s request, destroy, all documents or other tangible materials representing the Disclosing
Party’s Confidential Information (or any designated portion thereof); provided that one (1)
copy may be maintained in the confidential files of the Receiving Party for the purpose of
complying with the terms of this Agreement. An officer of the

38

 

Receiving Party also shall certify
in writing that it has satisfied its obligations under this Section 12.10 within ten (10)
days of a written request by the Disclosing Party.

     12.11 Special Damages. If Regeneron terminates this Agreement pursuant to Section 12.2 or 12.5, then
Sanofi shall pay to Regeneron, within sixty (60) days of the termination of this Agreement, in
addition to any other amount payable by Sanofi to Regeneron under this Agreement under Laws, or
pursuant to any contractual remedies available to Regeneron, an amount equal to the sum of the
Maximum Annual Discovery Program Costs for each of the years, including the remaining unpaid
Maximum Annual Discovery Program Cost for the Contract Year in which such termination is effective,
that would have been the remainder of the term of the Discovery Program but for the termination of
this Agreement.

     12.12 Termination by Sanofi At Will. Sanofi shall be entitled to terminate this Agreement at any time (except following a material
breach of this Agreement by Sanofi pursuant to Section 12.2) without cause upon three
months’ written notice to Regeneron. If Sanofi terminates the Agreement under this Section
12.12, then Sanofi shall pay to Regeneron within five (5) days of its notice of termination, an
amount equal to the sum of the Maximum Annual Discovery Program Costs for each of the years,
including the Remaining Unpaid Maximum Annual Discovery Program Cost for the Contract Year in which
such termination is effective, that would have been the remainder of the term of the Discovery
Program but for the termination of this Agreement. In addition, Sanofi shall complete GLP
toxicology studies conducted by Sanofi at the time of termination, if applicable, and such other
critical activities conducted by Sanofi at the time of termination that cannot be transferred to
Regeneron without a material adverse effect on the completion of such activities. In the event of
such termination, in addition to the provisions of Section 12.9, the following shall apply:

          (a) the rights granted to Sanofi under Sections 2.16, and 2.17 and Article
5 shall automatically terminate; and

          (b) Regeneron shall be granted a non-exclusive, non-transferable, royalty bearing (in
accordance with Section 4.4) worldwide license with the right to sublicense under Sanofi Target IP
existing at the effective time of termination solely for use to develop and commercialize (i) MTCs
against Program Targets, and (ii) any other Antibodies against Program Targets in the Discovery
Program in existence at the effective time of termination of this Agreement.

ARTICLE 13

ARBITRATION

     13.1 Binding Arbitration. In the event the Parties cannot reach agreement with respect to (i) the commercial
reasonableness of the budget for the Initial Development Plan for a Product Candidate, (ii) the
royalty on Net Sales of Immunoconjugates under Section 2.11(d)(i) and (iii) of this Agreement,
(iii) whether a breach constitutes a “material breach” as described in Section 12.2 of this
Agreement, and (iv) audits under Section 7.2(d) above, and such disputes are not resolved by the
Executive Officers in accordance with Section 3.3(b) above, then the following shall apply:

39

 

          (a) General. The respective disputed issue shall be referred to binding arbitration
by one (1) arbitrator who shall be an independent expert in the pharmaceutical or biotechnology
industry mutually acceptable to the Parties. The Parties shall use their best efforts to mutually
agree upon one (1) arbitrator; provided, however, that if the Parties have not done
so within ten (10) days after initiation of arbitration hereunder, or such longer period of time as
the Parties have agreed to in writing, then such arbitrator shall be an independent expert as
described in the preceding sentence selected by the New York office of the American Arbitration
Association. Such arbitration shall be limited to casting the deciding vote with respect to the
disputed issues as more fully described in Sections 13.1 (b)-(e) below. In connection therewith,
each Party shall submit to the arbitrator in writing its position on and desired resolution of such
matter. Such submission shall be made within ten (10) days of the selection or appointment of the
arbitrator, and the arbitrator shall rule on such matter within ten (10) days of receipt of the
written submissions by both Parties. The arbitrator shall select one of the Party’s positions
as his or her decision, and shall not have authority to render any substantive decision other than
to so select the position of either Regeneron or Sanofi. Except as provided in the preceding
sentence, such arbitration shall be conducted in accordance with the then-current Commercial
Arbitration Rules of the American Arbitration Association. The arbitrator’s ruling shall be final
and binding upon the Parties. The costs of any arbitration conducted pursuant to this Section
13.1 shall be borne equally by the Parties. The Parties shall use diligent efforts to cause
the completion of any such arbitration within sixty (60) days following a request by any Party for
such arbitration.

          (b) Initial Development Plan Budget. The specific issue that shall be submitted to
the arbitrator shall be limited to determining the overall commercial reasonableness of the budget
that is the subject of the dispute. If the arbitrator determines that such budget is commercially
reasonable, then the dispute shall be deemed finally resolved and such resolution shall be binding
on the Parties. However, if the arbitrator determines that such budget is not commercially
reasonable, then the arbitrator shall, within fifteen (15) days after such determination, render a
final decision as to what modifications must be made to such budget in order for it to be
commercially reasonable (the “Budget Modification Decision”). In connection with reaching a Budget
Modification Decision, the arbitrator may order the Parties to produce any documents or other
information which are relevant to such final decision, and the Parties shall submit such documents
or other information, together with their respective proposed resolutions which shall consist of
their respective proposed modifications to the budget in order for it to be commercially
reasonable, at least five (5) days prior to the date a Budget Modification Decision is required to
be rendered as provided above. In rendering the final decision, the arbitrator shall be limited to
choosing a resolution proposed by a Party without modification.

          (c) Royalty on Net Sales *********************: The issue that shall be submitted to
the arbitrator shall be the royalty rate to apply under Section 2.11(d)(i).

          (d) Material Breach Under Section 12.2: The issue that shall be submitted to the
arbitrator shall be whether the breach committed by a Party meets the requirements for a material
breach under Section 12.2 of this Agreement.

          (e) Audit Disputes. The issue that shall be submitted to the arbitrator shall be
disputes as described under Section 7.2(d) of this Agreement.

40

 

ARTICLE 14

MISCELLANEOUS

     14.1 Governing Law; Submission to Jurisdiction. This Agreement shall be governed by and construed in accordance with the Laws of the State of
New York, without regard to the conflict of laws principles thereof that would require the
application of the Law of any other jurisdiction. Except as set forth in Article 13 and
7.2(d), the Parties irrevocably and unconditionally submit to the exclusive jurisdiction of
the United States District Court for the Southern District of New York solely and specifically for
the purposes of any action or proceeding arising out of or in connection with this Agreement.

     14.2 Waiver. Waiver by a Party of a breach hereunder by the other Party shall not be construed as a waiver of
any subsequent breach of the same or any other provision. No delay or omission by a Party in
exercising or availing itself of any right, power or privilege hereunder shall preclude the later
exercise of any such right, power or privilege by such Party. No waiver shall be effective unless
made in writing with specific reference to the relevant provision(s) of this Agreement and signed
by a duly authorized representative of the Party granting the waiver.

     14.3 Notices. All notices, instructions and other communications required or permitted hereunder or in
connection herewith shall be in writing, shall be sent to the address of the relevant Party set
forth on Schedule 14.3 attached hereto and shall be (a) delivered personally, (b) sent via a
reputable nationwide overnight courier service, or (c) sent by facsimile transmission, with a
confirmation copy to be sent by registered or certified mail, return receipt requested, postage
prepaid. Any such notice, instruction or communication shall be deemed to have been delivered upon
receipt if delivered by hand, one (2) Business Days after it is sent via a reputable nationwide
overnight courier service or when transmitted with electronic confirmation of receipt, if
transmitted by facsimile (if such transmission is made during regular business hours of the
recipient on a Business Day; or otherwise, on the next Business Day following such transmission).
Either Party may change its address by giving notice to the other Party in the manner provided
above.

     14.4 Entire Agreement. This Agreement and the License and Collaboration Agreement contain the complete understanding of
the Parties with respect to the subject matter hereof and thereof and supersede all prior
understandings and writings relating to the subject matter hereof and thereof. It is understood and
agreed that in the event of any conflict or inconsistency between this Agreement and the License
and Collaboration Agreement, this Agreement shall control regarding the Parties’ rights and
obligations with respect to any Antibody (including any MTC), Lead Candidate or Product Candidate
in the Discovery Program (prior to Sanofi’s exercise of its Opt-In Rights with respect to such
Product Candidate), and the License and Collaboration Agreement shall control regarding the
Parties’ rights and obligations with respect to any Licensed Product from and after the time a
Product Candidate becomes a Licensed Product.

     14.5 Amendments. No provision in this Agreement shall be supplemented, deleted or amended except in a writing
executed by an authorized representative of each of Sanofi and Regeneron.

41

 

     14.6 Interpretation. The captions to the several Articles and Sections of this Agreement are included only for
convenience of reference and shall not in any way affect the construction of, or be taken into
consideration in interpreting, this Agreement. In this Agreement: (a) the word “including” shall
be deemed to be followed by the phrase “without limitation” or like expression; (b) references to
the singular shall include the plural and vice versa; (c) references to masculine, feminine and
neuter pronouns and expressions shall be interchangeable; and (d) the words “herein” or “hereunder”
relate to this Agreement. Each accounting term used herein that is not specifically defined herein
shall have the meaning given to it under GAAP, but only to the extent consistent with its usage and
the other definitions in this Agreement.

     14.7 Severability. If, under applicable Laws, any provision hereof is invalid or unenforceable, or otherwise
directly or indirectly affects the validity of any other material provision(s) of this Agreement in
any jurisdiction (“Modified Clause”), then, it is mutually agreed that this Agreement shall
endure and that the Modified Clause shall be enforced in such jurisdiction to the maximum extent
permitted under applicable Laws in such jurisdiction; provided that the Parties shall
consult and use all reasonable efforts to agree upon, and hereby consent to, any valid and
enforceable modification of this Agreement as may be necessary to avoid any unjust enrichment of
either Party and to match the intent of this Agreement as closely as possible, including the
economic benefits and rights contemplated herein. 

     14.8 Assignment. Except as otherwise expressly provided herein, neither this Agreement nor any of the rights or
obligations hereunder may be assigned by either Sanofi or Regeneron without (a) the prior written
consent of Regeneron in the case of any assignment by Sanofi or (b) the prior written consent of
Sanofi in the case of an assignment by Regeneron, except in each case (i) to an Affiliate of the
assigning Party that has and will continue to have the resources and financial wherewithal to fully
meet its obligations under this Agreement, provided that the assigning Party shall remain
primarily liable hereunder notwithstanding any such assignment, or (ii) to any Third Party who
acquires all or substantially all of the business of the assigning Party by merger, sale of assets
or otherwise, so long as such Affiliate or Third Party agrees in writing to be bound by the terms
of this Agreement. The assigning Party shall remain primarily liable hereunder notwithstanding any
such assignment. Any attempted assignment in violation hereof shall be void.

     14.9 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their
respective successors and permitted assigns, and shall also inure to the benefit of the Regeneron
Indemnitees and Sanofi Indemnitees to the extent provided in the last sentence of Section
14.12 below.

     14.10 Affiliates. Each Party may carry out its obligations under this Agreement through its Affiliates and
absolutely, unconditionally and irrevocably guarantees to the other Party prompt performance when
due and at all times thereafter of the responsibilities, liabilities, covenants, warranties,
agreements and undertakings of its Affiliates pursuant to this Agreement. Without limiting the
foregoing, neither Party shall cause or permit any of its Affiliates to commit any act (including
any act or omission) which such Party is prohibited hereunder from committing directly. Sanofi
shall not, directly or indirectly, cause or direct Sanofi Pasteur or Merial Limited to take any
action for which Sanofi and its Affiliates are prohibited hereunder from committing. Each Party
represents and warrants to the other Party that it has licensed or

42

 

will license from its Affiliates
the Patents and Know-How owned by its Affiliates that are to be licensed (or sublicensed) to the
other Party under this Agreement.

     14.11 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original but
which together shall constitute one and the same instrument.

     14.12 Third Party Beneficiaries. None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third
Party, including any creditor of any Party hereto. No Third Party shall obtain any right under any
provision of this Agreement or shall by reason of any such provision make any claim in respect of
any debt, liability or obligation (or otherwise) against any Party hereto. Notwithstanding the
foregoing, Article 10 is intended to benefit, in addition to the Parties, the other
Regeneron Indemnitees and Sanofi Indemnitees as if they were parties hereto, but this Agreement is
enforceable only by the Parties.

     14.13 Relationship of the Parties. Each Party shall bear its own costs incurred in the performance of its obligations hereunder
without charge or expense to the other Party except as expressly provided in this Agreement.
Neither Sanofi nor Regeneron shall have any responsibility for the hiring, termination or
compensation of the other Party’s employees or for any employee compensation or benefits of the
other Party’s employees. No employee or representative of a Party shall have any authority to bind
or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create
or impose any contractual or other liability on the other Party without said Party’s approval. For
all purposes, and notwithstanding any other provision of this Agreement to the contrary,
Regeneron’s legal relationship under this Agreement to Sanofi, and Sanofi’s legal relationship
under this Agreement to Regeneron, shall be that of an independent contractor. Nothing in this
Agreement shall be construed to establish a relationship of partners or joint ventures between the
Parties or any of their respective Affiliates.

     14.14 Limitation of Damages. EXCEPT AS SET FORTH IN SECTION 12.11, IN NO EVENT SHALL REGENERON OR SANOFI BE LIABLE
FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT
LIMITATION, LOSS OF PROFITS) SUFFERED BY THE OTHER PARTY, REGARDLESS OF THE THEORY OF LIABILITY
(INCLUDING CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE) AND REGARDLESS OF ANY PRIOR
NOTICE OF SUCH DAMAGES. HOWEVER, NOTHING IN THIS SECTION 14.14 IS INTENDED TO LIMIT OR
RESTRICT
THE INDEMNIFICATION RIGHTS AND OBLIGATIONS OF EITHER PARTY HEREUNDER WITH RESPECT TO THIRD PARTY
CLAIMS .

     14.15 Non-Solicitation. During the Term and for a period of two (2) years thereafter, neither Party shall solicit or
otherwise induce or attempt to induce any employee of the other Party directly involved in the
performance of the Discovery Program to leave the employment of the other Party and accept
employment with the first Party. Notwithstanding the foregoing, this prohibition on solicitation
does not apply to actions taken by a Party solely as a result of an employee’s affirmative response
to a general recruitment effort carried through a public solicitation or general solicitation.

43

 

     14.16 No Strict Construction. This Agreement has been prepared jointly and will not be construed against either Party.

[Remainder of page intentionally left blank; signature page follows]

44

 

     IN WITNESS WHEREOF, Sanofi and Regeneron have caused this Agreement to be executed by their
duly authorized representatives as of the day and year first above written.

	 	 	 	 	 
	 	AVENTIS PHARMACEUTICALS INC.

 	 
	 	By  	/s/ Karen Linehan
 	 
	 	 	Name:  	Karen Linehan 	 
	 	 	Title:  	Authorized Signatory 	 
	 

	 	 	 	 	 
	 	 	 
	 	By  	                     /s/ Robin White
 	 
	 	 	Name:  	Robin White 	 
	 	 	Title:  	Authorized Signatory 	 
	 

	 	 	 	 	 
	 	REGENERON PHARMACEUTICALS, INC.

 	 
	 	By  	/s/ Leonard Schleifer
 	 
	 	 	Name:  	Leonard Schleifer 	 
	 	 	Title:  	President & CEO 	 

45

 

	 	 	 	 	 

Exhibit 10.18

SCHEDULE 1.19

Excluded Candidates

Regeneron’s Excluded Candidates

**************

Sanofi’s Excluded Candidates

**************

 

 

Exhibit 10.18

SCHEDULE 1.42

Lead Candidate Criteria

**********************************.

 

 

Exhibit 10.18

SCHEDULE 1.46

Manufacturing Cost

***************************************.

 

 

Exhibit 10.18

SCHEDULE 1.94

Form of Target List

***********************

 

 

Exhibit 10.18

Schedule 4.4

************

 

 

Exhibit 10.18

SCHEDULE 8.3

***********************

 

 

Exhibit 10.18

SCHEDULE 14.3

Notices

If to Sanofi:

Aventis Pharmaceuticals Inc.

200 Crossing Boulevard

Bridgewater, New Jersey 08807

United States

Attn: President US Research and Development

	 	 	 
	Copy:

	 	Sanofi Aventis
	 

	 	174 Avenue de France
	 

	 	75013 Paris
	 

	 	France
	Attn:

	 	Senior Vice President and General Counsel

If to Regeneron:

Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, New York 10591

Attention: President & CEO

Copy: General Counsel

 

 

Exhibit 10.18

EXHIBIT A

Form of Opt-In Notice

[Sanofi Letterhead]

[DATE]

Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, New York 10591

Attention: President & CEO

Copy: General Counsel Regeneron Pharmaceuticals, Inc.

     Reference is hereby made to the Discovery and Preclinical Development Agreement (the
“Discovery Agreement”) by and between Aventis Pharmaceuticals Inc., a [   ], corporation with a
principal place of business located at [      ], and Regeneron Pharmaceuticals, Inc., a New York
corporation with a principal place of business located at 777 Old Saw Mill River Road, Tarrytown,
New York 10591. Capitalized terms used herein shall have the defined meanings set forth in the
Discovery Agreement.

     Pursuant to Section 5.4 of the Discovery Agreement, Sanofi hereby provides this Opt-In Notice
to Regeneron to license [INSERT PRODUCT CANDIDATE] under the License and Collaboration Agreement.
Effective immediately, [INSERT PRODUCT CANDIDATE] shall be considered a Licensed Product.

	 	 	 	 	 
	 

	 	AVENTIS PHARMACEUTICALS INC.
	 	 
	 
	 	 	 	 
	 

	 	 	 	 
	 

	 	Name:	 	 
	 

	 	Title:	 	 

 

 

Exhibit 10.18

EXHIBIT B

****************************

 

 

Exhibit 10.18

EXHIBIT C

************************EX-10.19

 

Exhibit 10.19

 

Portions of this Exhibit Have Been

Omitted and Separately Filed with the Securities

And Exchange Commission with a Request

For Confidential Treatment

LICENSE AND COLLABORATION AGREEMENT

By and Among

AVENTIS PHARMACEUTICALS INC.,

SANOFI-AVENTIS AMERIQUE DU NORD

and

REGENERON PHARMACEUTICALS, INC.

Dated as of November 28, 2007

 

TABLE OF CONTENTS

	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Page	 
	ARTICLE I DEFINITIONS	 	 	1	 
	 
	 	 	 	 	 	 	 	 
	 
	 	1.1	 	“Additional Major Market Country”	 	 	1	 
	 
	 	1.2	 	“Affiliate”	 	 	2	 
	 
	 	1.3	 	“Ancillary Agreements”	 	 	2	 
	 
	 	1.4	 	“Anticipated First Commercial Sale”	 	 	2	 
	 
	 	1.5	 	“Approval”	 	 	2	 
	 
	 	1.6	 	“Aventis LLC”	 	 	2	 
	 
	 	1.7	 	“Aventis Collaboration Agreement”	 	 	2	 
	 
	 	1.8	 	“Aventis Stock Purchase Agreement”	 	 	3	 
	 
	 	1.9	 	“BLA”	 	 	3	 
	 
	 	1.10	 	“Business Day”	 	 	3	 
	 
	 	1.11	 	“Clinical Supply Cost”	 	 	3	 
	 
	 	1.12	 	“Clinical Supply Requirements”	 	 	3	 
	 
	 	1.13	 	“Co-Commercialize” or
“Co-Commercialization”	 	 	3	 
	 
	 	1.14	 	“Co-Commercialization Country”	 	 	3	 
	 
	 	1.15	 	“COGS”	 	 	4	 
	 
	 	1.16	 	“Commercial Overhead Charge”	 	 	4	 
	 
	 	1.17	 	“Commercial Supply Cost”	 	 	4	 
	 
	 	1.18	 	“Commercial Supply Requirements”	 	 	4	 
	 
	 	1.19	 	“Commercialize” or “Commercialization”	 	 	4	 
	 
	 	1.20	 	“Commercially Reasonable Efforts”	 	 	4	 
	 
	 	1.21	 	“Committee”	 	 	5	 
	 
	 	1.22	 	“Competing Opt-Out Product”	 	 	5	 
	 
	 	1.23	 	“Competing Product”	 	 	5	 
	 
	 	1.24	 	“Confidentiality Agreements”	 	 	5	 
	 
	 	1.25	 	“Consolidated Payment Report”	 	 	5	 
	 
	 	1.26	 	“Contract Sales Force”	 	 	5	 
	 
	 	1.27	 	“Contract Year”	 	 	5	 
	 
	 	1.28	 	“Controlling Party”	 	 	5	 
	 
	 	1.29	 	“Co-Promote” or “Co-Promotion”	 	 	5	 
	 
	 	1.30	 	“Country/Region Commercialization Budget”	 	 	5	 
	 
	 	1.31	 	“Country/Region Commercialization Plan”	 	 	5	 
	 
	 	1.32	 	“Country/Region
Commercialization Committee”, or “CRCC”	 	 	6	 
	 
	 	1.33	 	“Detail”	 	 	6	 
	 
	 	1.34	 	“Develop” or “Development”	 	 	6	 
	 
	 	1.35	 	“Development Costs”	 	 	6	 
	 
	 	1.36	 	“Development FTE Cost”	 	 	7	 
	 
	 	1.37	 	“Development FTE Rate”	 	 	7	 
	 
	 	1.38	 	“Development Plan”	 	 	7	 
	 
	 	1.39	 	“Discovery Program”	 	 	7	 
	 
	 	1.40	 	“EMEA”	 	 	7	 

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	 	1.41	 	“Executive Officers”	 	 	8	 
	 
	 	1.42	 	“FDA”	 	 	8	 
	 
	 	1.43	 	“Field”	 	 	8	 
	 
	 	1.44	 	“Finished Product”	 	 	8	 
	 
	 	1.45	 	“First Commercial Sale”	 	 	8	 
	 
	 	1.46	 	“Formulated Bulk Product”	 	 	8	 
	 
	 	1.47	 	“FTE”	 	 	8	 
	 
	 	1.48	 	“GAAP”	 	 	8	 
	 
	 	1.49	 	“Global Commercialization Budget”	 	 	8	 
	 
	 	1.50	 	“Global Commercialization Plan”	 	 	8	 
	 
	 	1.51	 	“Global Development Budget”	 	 	8	 
	 
	 	1.52	 	“Global Development Plan”	 	 	9	 
	 
	 	1.53	 	“Good Practices”	 	 	9	 
	 
	 	1.54	 	“Governmental Authority”	 	 	9	 
	 
	 	1.55	 	“IAS/IFRS”	 	 	9	 
	 
	 	1.56	 	“ICH”	 	 	9	 
	 
	 	1.57	 	“IND”	 	 	9	 
	 
	 	1.58	 	“Indication”	 	 	9	 
	 
	 	1.59	 	“Initial Development Plan”	 	 	9	 
	 
	 	1.60	 	“Initial IND Filing Date”	 	 	9	 
	 
	 	1.61	 	“Investor Agreement”	 	 	9	 
	 
	 	1.62	 	“Joint Patent Rights”	 	 	9	 
	 
	 	1.63	 	“Know-How”	 	 	9	 
	 
	 	1.64	 	“Law” or “Laws”	 	 	10	 
	 
	 	1.65	 	“Lead Regulatory Party”	 	 	10	 
	 
	 	1.66	 	“Legal Dispute”	 	 	10	 
	 
	 	1.67	 	“License”	 	 	10	 
	 
	 	1.68	 	“Licensed Products”	 	 	10	 
	 
	 	1.69	 	“Major Market Country”	 	 	10	 
	 
	 	1.70	 	“Manufacture” or “Manufacturing”	 	 	10	 
	 
	 	1.71	 	“Marketing Approval”	 	 	10	 
	 
	 	1.72	 	“Manufacturing Plan”	 	 	10	 
	 
	 	1.73	 	“Medical Post-Approval Cost”	 	 	10	 
	 
	 	1.74	 	“Medical Post-Approval FTE Rate”	 	 	11	 
	 
	 	1.75	 	“Net Sales”	 	 	11	 
	 
	 	1.76	 	“New Information”	 	 	12	 
	 
	 	1.77	 	“Non-Approval Trials”	 	 	12	 
	 
	 	1.78	 	“Opt-In Right”	 	 	12	 
	 
	 	1.79	 	“Opt-Out Product”	 	 	12	 
	 
	 	1.80	 	“Other Shared Expenses”	 	 	12	 
	 
	 	1.81	 	“Out-of-Pocket Costs”	 	 	13	 
	 
	 	1.82	 	“Party Information”	 	 	13	 
	 
	 	1.83	 	“Patent Application”	 	 	13	 
	 
	 	1.84	 	“Patent Rights”	 	 	13	 
	 
	 	1.85	 	“Patents”	 	 	13	 
	 
	 	1.86	 	“Person”	 	 	13	 

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	 	1.87	 	“Phase 3 Trial”	 	 	13	 
	 
	 	1.88	 	“Plan”	 	 	13	 
	 
	 	1.89	 	“Positive Phase 3 Trial Results”	 	 	13	 
	 
	 	1.90	 	“Pre-Launch Marketing Expenses”	 	 	13	 
	 
	 	1.91	 	“Pricing Approval”	 	 	14	 
	 
	 	1.92	 	“Product Candidate”	 	 	14	 
	 
	 	1.93	 	“Product Trademark”	 	 	14	 
	 
	 	1.94	 	“Promotional Materials”	 	 	14	 
	 
	 	1.95	 	“Quarter” or “Quarterly”	 	 	14	 
	 
	 	1.96	 	“Regeneron Intellectual Property”	 	 	14	 
	 
	 	1.97	 	“Regeneron Know-How”	 	 	14	 
	 
	 	1.98	 	“Regeneron Patent Rights”	 	 	14	 
	 
	 	1.99	 	“Region”	 	 	14	 
	 
	 	1.100	 	“Registration Filing”	 	 	15	 
	 
	 	1.101	 	“Regulatory Authority”	 	 	15	 
	 
	 	1.102	 	“Reporting Country/Region”	 	 	15	 
	 
	 	1.103	 	“Rest of World” or “ROW”	 	 	15	 
	 
	 	1.104	 	“Rest of World Country”	 	 	15	 
	 
	 	1.105	 	“ROW CPI”	 	 	15	 
	 
	 	1.106	 	“Sales Force Cost”	 	 	15	 
	 
	 	1.107	 	“Sales Force FTE Rate”	 	 	15	 
	 
	 	1.108	 	“Sanofi Intellectual Property”	 	 	16	 
	 
	 	1.109	 	“Sanofi Know-How”	 	 	16	 
	 
	 	1.110	 	“Sanofi Patent Rights”	 	 	16	 
	 
	 	1.111	 	“Sanofi Stock Purchase Agreement”	 	 	16	 
	 
	 	1.112	 	“Shared Commercial Expenses”	 	 	16	 
	 
	 	1.113	 	“Shared Phase 3 Trial Costs”	 	 	17	 
	 
	 	1.114	 	“Sublicensee”	 	 	17	 
	 
	 	1.115	 	“Target”	 	 	18	 
	 
	 	1.116	 	“Terminated Licensed Product”	 	 	18	 
	 
	 	1.117	 	“Termination Notice Period”	 	 	18	 
	 
	 	1.118	 	“Territory”	 	 	18	 
	 
	 	1.119	 	“Third Party”	 	 	18	 
	 
	 	1.120	 	“United States,”
“US” or “U.S.”	 	 	18	 
	 
	 	1.121	 	“US CPI”	 	 	18	 
	 
	 	1.122	 	“Valid Claim”	 	 	18	 
	 
	 	1.123	 	Additional Definitions	 	 	18	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE II COLLABORATION	 	 	20	 
	 
	 	 	 	 	 	 	 	 
	 
	 	2.1	 	Scope of Collaboration	 	 	20	 
	 
	 	2.2	 	Compliance With Law	 	 	21	 
	 
	 	2.3	 	Further Assurances and Transaction Approvals	 	 	21	 
	 
	 	2.4	 	Compliance with Third Party Agreements	 	 	21	 
	 
	 	2.5	 	Plans	 	 	21	 
	 
	 	2.6	 	Limitation on Exercise of Rights Outside of Collaboration	 	 	21	 

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	ARTICLE III MANAGEMENT	 	 	26	 
	 
	 	 	 	 	 	 	 	 
	 
	 	3.1	 	Committees/Management	 	 	26	 
	 
	 	3.2	 	Joint Steering Committee	 	 	27	 
	 
	 	3.3	 	Joint Development Committee	 	 	28	 
	 
	 	3.4	 	Joint Commercialization Committee	 	 	29	 
	 
	 	3.5	 	Country/Region Commercialization Committees	 	 	31	 
	 
	 	3.6	 	Joint Finance Committee	 	 	31	 
	 
	 	3.7	 	Joint Manufacturing Committee	 	 	31	 
	 
	 	3.8	 	Membership	 	 	31	 
	 
	 	3.9	 	Meetings	 	 	32	 
	 
	 	3.10	 	Decision-Making	 	 	32	 
	 
	 	3.11	 	Resolution of Governance Matters	 	 	32	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE IV LICENSE GRANTS	 	 	33	 
	 
	 	 	 	 	 	 	 	 
	 
	 	4.1	 	Regeneron License Grants	 	 	33	 
	 
	 	4.2	 	Sanofi License Grants	 	 	33	 
	 
	 	4.3	 	Newly Created Intellectual Property	 	 	34	 
	 
	 	4.4	 	Sublicensing	 	 	34	 
	 
	 	4.5	 	No Implied License	 	 	35	 
	 
	 	4.6	 	Retained Rights	 	 	35	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE V DEVELOPMENT ACTIVITIES	 	 	35	 
	 
	 	 	 	 	 	 	 	 
	 
	 	5.1	 	Development of Licensed Products	 	 	35	 
	 
	 	5.2	 	Global Development Plans	 	 	35	 
	 
	 	5.3	 	Global Development Budgets	 	 	36	 
	 
	 	5.4	 	Development Reports	 	 	36	 
	 
	 	5.5	 	Review of Clinical Trial Protocols	 	 	37	 
	 
	 	5.6	 	Regeneron Early Development Opt-Out	 	 	37	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE VI COMMERCIALIZATION	 	 	38	 
	 
	 	 	 	 	 	 	 	 
	 
	 	6.1	 	Commercialization of Licensed Products in the Field in the Territory	 	 	38	 
	 
	 	6.2	 	Global Commercialization Plan(s)	 	 	38	 
	 
	 	6.3	 	Country/Region Commercialization Plans	 	 	39	 
	 
	 	6.4	 	Commercialization Efforts; Sharing of Commercial Information	 	 	39	 
	 
	 	6.5	 	Co-Commercialization of Licensed Products	 	 	40	 
	 
	 	6.6	 	Licensed Product Pricing and Pricing Approvals in the Territory	 	 	42	 
	 
	 	6.7	 	Sales and Licensed Product Distribution in the Territory; Other Responsibilities	 	 	42	 
	 
	 	6.8	 	Contract Sales Force	 	 	43	 
	 
	 	6.9	 	Promotional Materials	 	 	43	 
	 
	 	6.10	 	Promotional Claims/Compliance	 	 	44	 
	 
	 	6.11	 	Restriction on Bundling in the Territory	 	 	44	 
	 
	 	6.12	 	Inventory Management	 	 	44	 
	 
	 	6.13	 	Medical and Consumer Inquiries	 	 	44	 
	 
	 	6.14	 	Market Exclusivity Extensions	 	 	44	 
	 
	 	6.15	 	Post Marketing Clinical Trials	 	 	44	 

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	ARTICLE VII CLINICAL AND REGULATORY AFFAIRS	 	 	44	 
	 
	 	 	 	 	 	 	 	 
	 
	 	7.1	 	Ownership of Approvals and Registration Filings	 	 	44	 
	 
	 	7.2	 	Regulatory Coordination	 	 	45	 
	 
	 	7.3	 	Regulatory Events	 	 	46	 
	 
	 	7.4	 	Pharmacovigilance and Product Complaints	 	 	47	 
	 
	 	7.5	 	Regulatory Inspection or Audit	 	 	47	 
	 
	 	7.6	 	Recalls and Other Corrective Actions	 	 	47	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE VIII MANUFACTURING AND SUPPLY	 	 	48	 
	 
	 	 	 	 	 	 	 	 
	 
	 	8.1	 	Manufacture and Supply of Clinical
Supply Requirements of Formulated Bulk Product	 	 	48	 
	 
	 	8.2	 	Finished Product Supply of Clinical Supply Requirements	 	 	48	 
	 
	 	8.3	 	Manufacture and Supply of Commercial Supply Requirements	 	 	48	 
	 
	 	8.4	 	Supply Agreement	 	 	49	 
	 
	 	8.5	 	Process Development and Manufacturing Plans	 	 	50	 
	 
	 	8.6	 	Manufacturing Shortfall	 	 	50	 
	 
	 	8.7	 	Manufacturing Compliance	 	 	50	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE IX PERIODIC REPORTS; PAYMENTS	 	 	51	 
	 
	 	 	 	 	 	 	 	 
	 
	 	9.1	 	Development Costs	 	 	51	 
	 
	 	9.2	 	Milestone Payments	 	 	51	 
	 
	 	9.3	 	Royalties	 	 	51	 
	 
	 	9.4	 	Sharing of Profits from Licensed Products	 	 	51	 
	 
	 	9.5	 	Periodic Reports	 	 	51	 
	 
	 	9.6	 	Funds Flow	 	 	52	 
	 
	 	9.7	 	Invoices and Documentation	 	 	53	 
	 
	 	9.8	 	Payment Method and Currency	 	 	53	 
	 
	 	9.9	 	Late Payments	 	 	53	 
	 
	 	9.10	 	Taxes	 	 	53	 
	 
	 	9.11	 	Adjustments to FTE Rates	 	 	53	 
	 
	 	9.12	 	Resolution of Payment Disputes	 	 	54	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE X DISPUTE RESOLUTION	 	 	54	 
	 
	 	 	 	 	 	 	 	 
	 
	 	10.1	 	Resolution of Disputes	 	 	54	 
	 
	 	10.2	 	Governance Disputes	 	 	54	 
	 
	 	10.3	 	Legal Disputes	 	 	54	 
	 
	 	10.4	 	Expert Panel	 	 	54	 
	 
	 	10.5	 	No Waiver	 	 	57	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XI TRADEMARKS AND CORPORATE LOGOS	 	 	57	 
	 
	 	 	 	 	 	 	 	 
	 
	 	11.1	 	Corporate Names	 	 	57	 
	 
	 	11.2	 	Selection of Product Trademarks	 	 	57	 
	 
	 	11.3	 	Ownership of Product Trademarks	 	 	57	 
	 
	 	11.4	 	Prosecution and Maintenance of Product Trademark(s)	 	 	57	 
	 
	 	11.5	 	License to the Product Trademark(s)	 	 	57	 
	 
	 	11.6	 	Use of Corporate Names	 	 	58	 

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	ARTICLE XII NEWLY CREATED INVENTIONS AND KNOW-HOW	 	 	58	 
	 
	 	 	 	 	 	 	 	 
	 
	 	12.1	 	Ownership of Newly Created Intellectual Property	 	 	58	 
	 
	 	12.2	 	Prosecution and Maintenance of Patent Rights	 	 	60	 
	 
	 	12.3	 	Interference, Opposition and Reissue	 	 	63	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XIII INTELLECTUAL PROPERTY LITIGATION AND LICENSES	 	 	64	 
	 
	 	 	 	 	 	 	 	 
	 
	 	13.1	 	Third Party Infringement Suits	 	 	64	 
	 
	 	13.2	 	Patent Marking	 	 	65	 
	 
	 	13.3	 	Third Party Infringement Claims; New Licenses	 	 	65	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XIV BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS	 	 	66	 
	 
	 	 	 	 	 	 	 	 
	 
	 	14.1	 	Books and Records	 	 	66	 
	 
	 	14.2	 	Audits and Adjustments	 	 	66	 
	 
	 	14.3	 	GAAP/IAS/IFRS	 	 	67	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XV REPRESENTATIONS, WARRANTIES and Covenants	 	 	67	 
	 
	 	 	 	 	 	 	 	 
	 
	 	15.1	 	Due Organization, Valid Existence and Due Authorization; Financial Capability	 	 	67	 
	 
	 	15.2	 	Knowledge of Pending or Threatened Litigation	 	 	68	 
	 
	 	15.3	 	Additional Regeneron Representations, Warranties and Covenants	 	 	68	 
	 
	 	15.4	 	Disclaimer of Warranties	 	 	69	 
	 
	 	15.5	 	Mutual Covenants	 	 	69	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XVI CONFIDENTIALITY	 	 	69	 
	 
	 	 	 	 	 	 	 	 
	 
	 	16.1	 	Confidential Information	 	 	69	 
	 
	 	16.2	 	Injunctive Relief	 	 	71	 
	 
	 	16.3	 	Publication of New Information	 	 	71	 
	 
	 	16.4	 	Disclosures Concerning this Agreement	 	 	71	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XVII INDEMNITY	 	 	72	 
	 
	 	 	 	 	 	 	 	 
	 
	 	17.1	 	Indemnity and Insurance	 	 	72	 
	 
	 	17.2	 	Indemnity Procedure	 	 	74	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XVIII FORCE MAJEURE	 	 	75	 
	 
	 	 	 	 	 	 	 	 
	ARTICLE XIX TERM AND TERMINATION	 	 	75	 
	 
	 	 	 	 	 	 	 	 
	 
	 	19.1	 	Term/Expiration of Term	 	 	75	 
	 
	 	19.2	 	Termination Without Cause	 	 	76	 
	 
	 	19.3	 	Termination For Material Breach	 	 	78	 
	 
	 	19.4	 	Termination for Insolvency	 	 	78	 
	 
	 	19.5	 	Termination for Breach of Standstill or Lock-Up	 	 	79	 
	 
	 	19.6	 	Termination of Discovery Agreement	 	 	79	 
	 
	 	19.7	 	Effect of Termination	 	 	79	 
	 
	 	19.8	 	Survival of Obligations	 	 	80	 

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	ARTICLE XX MISCELLANEOUS	 	 	81	 
	 
	 	 	 	 	 	 	 	 
	 
	 	20.1	 	Governing Law; Submission to Jurisdiction	 	 	81	 
	 
	 	20.2	 	Waiver	 	 	81	 
	 
	 	20.3	 	Notices	 	 	81	 
	 
	 	20.4	 	Entire Agreement	 	 	82	 
	 
	 	20.5	 	Amendments	 	 	82	 
	 
	 	20.6	 	Interpretation	 	 	82	 
	 
	 	20.7	 	Severability	 	 	82	 
	 
	 	20.8	 	Registration and Filing of the Agreement	 	 	82	 
	 
	 	20.9	 	Assignment	 	 	82	 
	 
	 	20.10	 	Successors and Assigns	 	 	83	 
	 
	 	20.11	 	Affiliates	 	 	83	 
	 
	 	20.12	 	Counterparts	 	 	83	 
	 
	 	20.13	 	Third-Party Beneficiaries	 	 	83	 
	 
	 	20.14	 	Relationship of the Parties	 	 	84	 
	 
	 	20.15	 	Limitation of Damages	 	 	84	 
	 
	 	20.16	 	Non-Solicitation	 	 	84	 
	 
	 	20.17	 	No Strict Construction	 	 	84	 

vii

 

LICENSE AND COLLABORATION AGREEMENT

     THIS LICENSE AND COLLABORATION AGREEMENT (this “Agreement”), dated as of November 28,
2007 (the “Effective Date”), is by and between AVENTIS PHARMACEUTICALS INC., a corporation
organized under the laws of the state of Delaware having a principal place of business at 55
Corporate Drive, Bridgewater, New Jersey 08807 (“Sanofi”), an indirect wholly owned
subsidiary of sanofi-aventis, a company organized under the laws of France with its principal
headquarters at 174, avenue de France, 75013 Paris, France (“Sanofi Parent”),
SANOFI-AVENTIS AMERIQUE DU NORD, a partnership organized under the laws of France with its
principal headquarters at 174 avenue de France, 75013 Paris, France (“Sanofi Amerique”),
and REGENERON PHARMACEUTICALS, INC., a corporation organized under the laws of the state of New
York having a principal place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591
(“Regeneron”) (with each of Sanofi and Regeneron being sometimes referred to herein
individually as a “Party” and collectively as the “Parties”, and with Sanofi
Amerique being a party to this Agreement for purposes of Sections 15.1, 15.2 and 20.11 only).

     WHEREAS, concurrently with the execution and delivery of this Agreement, the Parties have
entered into a Discovery and Preclinical Development Agreement (the “Discovery Agreement”)
whereby, upon the terms and conditions set forth therein, Regeneron will use its proprietary
VelocImmune® technology and related suite of technologies with the objective of
discovering Product Candidates (as defined below) which Sanofi may elect, in accordance with the
Discovery Agreement, to advance into Development (as defined below) and thereupon automatically
obtain from Regeneron a license of certain rights thereto upon the terms and conditions set forth
herein;

     WHEREAS, Sanofi and its Affiliates possess knowledge and expertise in, and resources for,
developing and commercializing pharmaceutical products in the Field in the Territory (each as
defined below);

     WHEREAS, Regeneron and Sanofi desire to collaborate on the Development, Manufacture and
Commercialization of Licensed Products (each as defined below) in the Field in the Territory upon
the terms and conditions set forth herein (the “Collaboration”); and

     NOW, THEREFORE, in consideration of the following mutual covenants contained herein, and for
other good and valuable consideration the adequacy and sufficiency of which are hereby
acknowledged, the Parties agree as follows:

ARTICLE I

DEFINITIONS

     Capitalized terms used in this Agreement, whether used in the singular or plural, except as
expressly set forth herein, shall have the meanings set forth below:

     1.1 “Additional Major Market Country” shall mean any country in the Territory, other
than the Major Market Countries referred to in clause (i) of the definition thereof, in which Net
Sales in the immediately preceding Contract Year were *********** or more of

 

 

aggregate Net Sales in the Territory, and such designation shall remain effective from
and after the determination of such Net Sales amount; provided, however, that a country shall not
be deemed an Additional Major Market Country if, at the time that Net Sales in such country in a
given Contract Year first exceed *********** of aggregate Net Sales in the Territory, the Parties
mutually agree otherwise.

          1.2 “Affiliate” shall mean, with respect to any Person, another Person which controls,
is controlled by or is under common control with such Person. A Person shall be deemed to control
another Person if such Person possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of such Person, whether through the ownership of voting
securities, by contract or otherwise. Without limiting the generality of the foregoing, a Person
shall be deemed to control another Person if any of the following conditions is met: (a) in the
case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the
stock or shares having the right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity
interest with the power to direct the management and policies of such non-corporate entities. The
Parties acknowledge that in the case of certain entities organized under the laws of certain
countries outside of the United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in such case such lower percentage
shall be substituted in the preceding sentence, provided that such foreign investor has the power
to direct the management and policies of such entity. For purposes of this Agreement, in no event
shall Sanofi or any of its Affiliates be deemed Affiliates of Regeneron or any of its Affiliates.
For purposes of this Agreement, neither Sanofi Pasteur nor Merial Limited, nor any of their
respective subsidiaries or joint ventures, shall be deemed to be Affiliates of Sanofi or any of its
Affiliates.

          1.3 “Ancillary Agreements” means the Sanofi Stock Purchase Agreement and the Investor
Agreement.

          1.4 “Anticipated First Commercial Sale” shall mean, with respect to a Licensed Product
in the Field, the date agreed upon by the JSC in advance as the expected date of First Commercial
Sale of such Licensed Product in the Field in a country in the Territory.

          1.5 “Approval” shall mean, with respect to each Licensed Product, any approval
(including Marketing Approvals and Pricing Approvals), registration, license or authorization from
any Regulatory Authority required for the Development, Manufacture or Commercialization of such
Licensed Product in the Field in a regulatory jurisdiction anywhere in the world, and shall
include, without limitation, an approval, registration, license or authorization granted in
connection with any Registration Filing.

          1.6 “Aventis LLC” shall mean sanofi-aventis US LLC (successor in interest under the
Aventis Collaboration Agreement to Aventis Pharmaceuticals Inc.).

          1.7 “Aventis Collaboration Agreement” shall mean the Collaboration Agreement, dated as
of September 5, 2003, by and between Aventis LLC and Regeneron, as amended by the First Amendment,
dated as of December 31, 2004, the Second Amendment, dated as of January 7, 2005, the Third
Amendment, dated as of December 21, 2005, the Fourth

2

 

Amendment, dated as of January 31, 2006, and Section 11.2 of the Sanofi Stock Purchase
Agreement, as the same may be further amended from time to time.

          1.8 “Aventis Stock Purchase Agreement” shall mean the Stock Purchase Agreement dated
as of September 5, 2003 by and between Aventis Pharmaceuticals Inc. and Regeneron, as amended by
Sections 4.2(b) and 4.4 of the Investor Agreement effective upon the execution and delivery of the
Investor Agreement, and as may be further amended from time to time.

          1.9 “BLA” shall mean, with respect to each Licensed Product, a biologics license
application filed with respect to such Licensed Product, as described in the FDA regulations,
including all amendments and supplements to the application, and any equivalent filing with any
Regulatory Authority.

          1.10 “Business Day” shall mean any day other than a Saturday, a Sunday or a day on
which commercial banks in New York, New York, the United States or Paris, France are authorized or
required by Law to remain closed.

          1.11 “Clinical Supply Cost” shall mean (a) the Out-of-Pocket Cost for purchasing
and/or the Manufacturing Cost to Manufacture Formulated Bulk Product for Clinical Supply
Requirements under the applicable Global Development Plan, (b) the Out-of-Pocket Cost for
purchasing and/or the Manufacturing Cost to Manufacture, comparator agent or placebo requirements
for activities contemplated under the applicable Global Development Plan, (c) the Out-of-Pocket
Cost and/or the Manufacturing Cost for filling, packaging, labeling and delivery of such Clinical
Supply Requirements, comparator agent, combination agent and/or placebo, as the case may be, for
activities contemplated under the applicable Global Development Plan and (d) any irrecoverable VAT
or similar taxes actually paid with respect to the Manufacture or delivery of Clinical Supply
Requirements. To the extent that manufacturing cost for comparator agent, combination agent or
placebo includes any markup over Manufacturing Cost to the benefit of one of the Parties or its
Affiliates, such markup shall be deducted in the calculation of Clinical Supply Cost.

          1.12 “Clinical Supply Requirements” shall mean, with respect to a Licensed Product,
the quantities of such Licensed Product which are required by a Party or the Parties for
Development in the Field under this Agreement, including, without limitation, the conduct of
research, pre-clinical studies and clinical trials in connection with a Development Plan and
quantities of such Licensed Product which are required by a Party for submission to a Regulatory
Authority in connection with any Registration Filing or Approval in the Field in any regulatory
jurisdiction in the Territory.

          1.13 “Co-Commercialize” or “Co-Commercialization” shall mean the act of
Co-Promoting in a Co-Commercialization Country.

          1.14 “Co-Commercialization Country” shall mean each country in which Regeneron has
elected to Co-Promote a Licensed Product, so long as, after commencing such Co-Promotion, Regeneron
is Co-Promoting at least one Licensed Product in such country.

3

 

          1.15 “COGS” for a Licensed Product for a Quarter shall mean cost (calculated in
accordance with IAS/IFRS) of Manufacturing the Licensed Product sold in the Field in the Territory
in the Quarter.

          1.16 “Commercial Overhead Charge” shall mean, on a country-by-country and Licensed
Product-by-Licensed Product basis in the Territory, beginning in the Contract Year of First
Commercial Sale in the applicable country, an amount (agreed upon by the JFC at least six (6)
months prior to the Anticipated First Commercial Sale in the country) to cover
**************************************, such amount to be determined by the JFC as of January 1 of
each following Contract Year. For the avoidance of doubt, “Commercial Overhead Charge”
shall not include any amounts included in Medical Post-Approval Cost, Sales Force Cost, Other
Shared Expenses or Shared Commercial Expenses.

          1.17 “Commercial Supply Cost” shall mean the Out-of-Pocket Cost for purchasing and/or
the Manufacturing Cost for the Manufacture of Commercial Supply Requirements, including, without
limitation, scale-up after First Commercial Sale, any filling, packaging and labeling costs, and
any irrecoverable VAT or similar taxes actually paid with respect to the Manufacture or delivery of
such Commercial Supply Requirements.

          1.18 “Commercial Supply Requirements” shall mean, with respect to each Licensed
Product, quantities of Finished Product as are required to fulfill requirements for commercial
sales, Non-Approval Trials and product sampling with respect to such Licensed Product in the Field
in the Territory.

          1.19 “Commercialize” or “Commercialization” shall mean, with respect to a
Licensed Product, any and all activities directed to marketing, promoting (including, if
applicable, Co-Promoting), detailing, distributing, importing, offering for sale, having sold
and/or selling such Licensed Product in the Field in the Territory, including, without limitation,
market research, obtaining Pricing Approvals, pre-launch marketing
************************************.

          1.20 “Commercially Reasonable Efforts” shall mean 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. Commercially Reasonable
Efforts shall be determined on a market-by-market and Licensed Product-by-Licensed Product basis in
view of conditions prevailing at the time, and evaluated taking into account all relevant factors,
including without limitation, the efficacy, safety, anticipated regulatory authority approved
labeling, competitiveness of the Licensed Product or alternative products that are in the
marketplace or under development by Third Parties and other technical, scientific, legal, medical
marketing and competitiveness factors. It is anticipated that the level of effort constituting
Commercially Reasonable Efforts may change over time. In determining whether a Party has used
Commercially Reasonable Efforts, neither the profit sharing nor other payments made or required to
be made hereunder shall be factor weighed (that is, a Party may not apply lesser resources or
efforts in support of a Licensed Product because it must share profits from sales of such Licensed
Product or make any other payments hereunder).

4

 

          1.21 “Committee” means any of the JSC, JDC, JCC, JMC, JFC, any CRCC, and any other
committee established by the Parties or by the Committees referenced above, each as described in
Article III (together with Working Groups or other committees contemplated herein or established in
accordance with this Agreement).

          1.22 “Competing Opt-Out Product” shall mean any Opt-Out Product having the same Target
as a Licensed Product.

          1.23 “Competing Product” shall mean, with respect to a Licensed Product,
****************************************.

          1.24 “Confidentiality Agreements” shall mean the confidentiality agreements between
Regeneron and Sanofi Parent dated February 1, 2007 and October 23, 2007, respectively.

          1.25 “Consolidated Payment Report” shall mean a consolidated Quarterly report prepared
by Sanofi (based on information reported under Sections 5.4 and 9.5) setting forth in reasonable
detail, for each Major Market Country in the Territory, for each Region in the Territory, and in
the aggregate for all countries in the Territory, (a) Net Sales, COGS and Shared Commercial
Expenses incurred by each Party for such Quarter, (b) Development Costs incurred by each Party for
such Quarter, (c) Other Shared Expenses incurred by each Party for such Quarter, and (d) the
Quarterly True-Up, and the component items and calculations in determining such Quarterly True-Up,
calculated in accordance with Schedule 2.

          1.26 “Contract Sales Force” shall mean sales representatives employed by a Third
Party.

          1.27 “Contract Year” shall mean the period beginning on the Effective Date and ending
on December 31, 2008, and each succeeding consecutive twelve (12) month period thereafter during
the Term. The last Contract Year of the Term shall begin on January 1 for the year during which
termination or expiration of the Agreement will occur, and the last day of such Contract Year shall
be the effective date of such termination or expiration.

          1.28 “Controlling Party” shall mean ***************************.

          1.29 “Co-Promote” or “Co-Promotion” shall mean the joint marketing and
promotion of Licensed Product(s) by the Parties (or their respective Affiliates) under the same
trademark in a Major Market Country pursuant to the applicable Country/Region Commercialization
Plan.

          1.30 “Country/Region Commercialization Budget” shall mean the budget for a particular
calendar year approved by the JCC for the applicable Country/Region Commercialization Plan.

          1.31 “Country/Region Commercialization Plan” shall mean, for each Reporting
Country/Region, the three (3) year rolling plan for Commercializing Licensed Products in the Field
in such country or Region and the related Country/Region Commercialization Budget and a

5

 

non-binding budget forecast for the next two (2) calendar years, approved by the JCC, as the same
may be amended from time-to-time in accordance with the terms of this Agreement. Each
Country/Region Commercialization Plan shall set forth, for each Licensed Product, the information,
plans and forecasts set forth in Section 6.3.

          1.32 “Country/Region Commercialization Committee”, or “CRCC” , shall mean the
committee established by the JCC for a particular Reporting Country/Region as described in Section
3.5.

          1.33 “Detail” shall mean, with respect to each Licensed Product in the Field, a
selling presentation for such product by a representative of each Party’s sales force, or another
employee of each Party who may be deemed to be part of the Commercialization effort for such
Licensed Product (e.g., such as a key account manager, etc.).

          1.34 “Develop” or “Development” shall mean, with respect to a Licensed
Product, the following activities undertaken or performed after the Initial IND Filing Date for
such Licensed Product: (a) activities relating to research, pre-clinical and clinical drug
development of such Licensed Product in the Field, including, without limitation, test method
development and stability testing, assay development, toxicology, pharmacology, formulation,
quality assurance/quality control development, technology transfer, statistical analysis, process
development and scale-up, pharmacokinetic studies, data collection and management, clinical studies
(including research to design clinical studies), regulatory affairs, project management, drug
safety surveillance activities related to clinical studies, the preparation and submission of
Registration Filings but excluding activities necessary to obtain a Pricing Approval,
reimbursement and/or listing on health care providers’ and payers’ formularies, (b)
************************** and (c) any other research and development activities with respect to
such Licensed Product in the Field, including, without limitation, activities to support the
discovery of biomarkers and activities to support new product formulations, delivery technologies
and/or new indications in the Field, either before or after the First Commercial Sale.

          1.35 “Development Costs” shall mean costs incurred by a Party (for each Licensed
Product, commencing with the first (1st) day of the month in which the Opt-In Notice (as such term
is defined in the Discovery Agreement) for such Licensed Product is received by Regeneron) directly
in connection with the Development of Licensed Products in the Field in accordance with this
Agreement and the applicable Global Development Plan, including without limitation:

          (a) all Out-of-Pocket Costs, including, without limitation, fees and expenses
associated with obtaining Registration Filings and Marketing Approvals necessary for the
Development and Commercialization of the Licensed Products in the Field under this
Agreement;

          (b) Development FTE Costs;

          (c) Clinical Supply Costs;

6

 

          (d) the costs and expenses incurred in connection with (i) Manufacturing process,
formulation, cleaning, and shipping development and validation (other than validation
batches which are sold), (ii), Manufacturing scale-up and improvements, (iii) stability
testing, (iv) quality assurance/quality control development (including management of Third
Party fillers, packagers and labelers), and (v) internal and Third Party costs and expenses
incurred in connection with (A) qualification and validation of Third Party contract
manufacturers and vendors and (B) subject to the terms of this Agreement, establishing a
primary or secondary source supplier, including, without limitation, the transfer of process
and Manufacturing technology and analytical methods, scale-up up to First Commercial Sale,
process and equipment validation, cleaning validation and initial Manufacturing licenses,
approvals and Regulatory Authority inspections (in each case, to the extent not included in
Clinical Supply Costs or Commercial Supply Costs);

          (e) any license fees and other payments under Licenses to the extent attributable to
the Manufacture of Clinical Supply Requirements and/or the Development of Licensed Products
in the Field under the Plans for the Territory subject to Section 13.3(e) in this Agreement;
and

          (f) any other costs or expenses specifically identified and included in the applicable
Development Plan or included as Development Costs under this Agreement.

          1.36 “Development FTE Cost” shall mean, for all Development activities performed in
accordance with the Development Plan(s), including regulatory activities, the product of (a) the
number of FTEs required for such Development activity as set forth in the approved Development Plan
and (b) the Development FTE Rate. For the avoidance of doubt, the activity of contract personnel
shall be charged as Out-of-Pocket Costs.

          1.37 “Development FTE Rate” shall mean ******* in the first (1st) Contract Year, such
amount to be adjusted as of January 1, 2009 and annually thereafter by the sum of (a) the average
of the percentage increases or decreases, if any, in the US CPI and the ROW CPI for the twelve (12)
months ending June 30 of the Contract Year prior to the Contract Year for which the adjustment is
being made *******************************, the Parties shall meet to consider a revision to the
Development FTE Rate.

          1.38 “Development Plan” shall mean a Global Development Plan or an Initial Development
Plan, as the context requires.

          1.39 “Discovery Program” shall have the meaning set forth in the Discovery Agreement.

          1.40 “EMEA” shall mean the European Medicines Evaluation Agency or any successor
agency thereto.

7

 

          1.41 “Executive Officers” shall mean the Chief Executive Officer of Regeneron and the
Chief Executive Officer of Sanofi Parent, or their respective designees with equivalent
decision-making authority with respect to matters under this Agreement.

          1.42 “FDA” shall mean the United States Food and Drug Administration and any successor
agency thereto.

          1.43 “Field” shall mean the treatment, prevention, palliation and/or diagnosis of any
disease.

          1.44 “Finished Product” shall mean a Licensed Product in the Field in its finished,
labeled and packaged form, ready for sale to the market or use in clinical or pre-clinical trials,
as the case may be.

          1.45 “First Commercial Sale” shall mean, with respect to a Licensed Product in a
country in the Territory, the first commercial sale of the Finished Product to non-Sublicensee
Third Parties for use in the Field in such country (or group of countries) following receipt of
Marketing Approval. Sales for test marketing or clinical trial purposes or compassionate or
similar use shall not constitute a First Commercial Sale.

          1.46 “Formulated Bulk Product” shall mean Licensed Product in the Field formulated
into solution or in a lyophilized form, ready for storage or shipment to a manufacturing facility,
to allow processing into the final dosage form.

          1.47 “FTE” shall mean a full time equivalent employee (i.e., one
fully-committed or multiple partially-committed employees aggregating to one full-time employee)
employed or contracted by a Party and assigned to perform specified work, with such commitment of
time and effort to constitute one employee performing such work on a full-time basis, which for
purposes of Development shall be ***** per year.

          1.48 “GAAP” shall mean generally accepted accounting principles as applicable in the United States.

          1.49 “Global Commercialization Budget” shall mean the budget(s) for a particular
Contract Year approved by the JCC for the applicable Global Commercialization Plan.

          1.50 “Global Commercialization Plan” shall mean, with respect to a Licensed Product,
the three (3) year rolling plan approved by the JSC for Commercializing such Licensed Product
throughout the world, including the related Global Commercialization Budget and a non-binding
budget forecast for the next two (2) Contract Years, as the same may be amended from time-to-time
in accordance with the terms of this Agreement. Each Global Commercialization Plan shall set forth
(if not otherwise set forth in the applicable Country/Region Commercialization Plan(s)) for a
Licensed Product, the information, plans and forecasts set forth in Section 6.2.

          1.51 “Global Development Budget” shall mean the budget(s) for a particular Contract
Year approved by the JSC for the applicable Global Development Plan.

8

 

          1.52 “Global Development Plan” shall mean, with respect to a Licensed Product, the
Initial Development Plan and the three (3) year rolling plan approved by the JSC for the worldwide
Development of such Licensed Product, including the related Global Development Budget and a
non-binding budget forecast for the next two (2) Contract Years, as the same may be amended from
time-to-time in accordance with the terms of this Agreement. For the avoidance of doubt, a Global
Development Plan will not include Non-Approval Trials.

          1.53 “Good Practices” shall mean compliance with the applicable standards contained in
then-current “Good Laboratory Practices,” “Good Manufacturing Practices” and/or “Good Clinical
Practices,” as promulgated by the FDA and all analogous guidelines promulgated by the EMEA or the
ICH, as applicable.

          1.54 “Governmental Authority” shall mean any court, agency, authority, department,
regulatory body or other instrumentality of any government or country or of any national, federal,
state, provincial, regional, county, city or other political subdivision of any such government or
any supranational organization of which any such country is a member.

          1.55 “IAS/IFRS” shall mean International Accounting Standards/International Financial Reporting Standards of
the International Accounting Standards Board.

          1.56 “ICH” shall mean the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use.

          1.57 “IND” shall mean, with respect to each Licensed Product in the Field, an
Investigational New Drug Application filed with respect to such Licensed Product, as described in
the FDA regulations, including all amendments and supplements to the application, and any
equivalent filing with any Regulatory Authority outside the United States.

          1.58 “Indication” means any disease.

          1.59 “Initial Development Plan” shall have the meaning set forth in the Discovery
Agreement.

          1.60 “Initial IND Filing Date” means, with respect to a Licensed Product, the date an
IND for such Licensed Product is first filed.

          1.61 “Investor Agreement” means the Investor Agreement by and among Sanofi Parent,
Sanofi, Aventis LLC, Sanofi Amerique and Regeneron, substantially in the form of Exhibit B to the
Sanofi Stock Purchase Agreement, which will be entered into concurrently with the closing under the
Sanofi Stock Purchase Agreement.

          1.62 “Joint Patent Rights” shall mean Patent Rights that cover a Joint Invention.

          1.63 “Know-How” shall mean, with respect to each Party and its Affiliates, any and all
proprietary technical or scientific information, know-how, data, test results, knowledge,
techniques, discoveries, inventions, specifications, designs, trade secrets, regulatory filings and
other information, including marketing and supply information, (whether or not patentable or

9

 

otherwise protected by trade secret Law) and that are not disclosed or claimed by such Party’s
Patents or Patent Applications.

          1.64 “Law” or “Laws” shall mean all laws, statutes, rules, regulations,
orders, judgments, injunctions and/or ordinances of any Governmental Authority.

          1.65 “Lead Regulatory Party” shall mean the Party having responsibility for preparing,
prosecuting and maintaining Registration Filings and any Approvals for Licensed Products in the
Field under this Agreement, and for related regulatory duties.

          1.66 “Legal Dispute” shall mean any dispute related to a Party’s alleged failure to
comply with this Agreement or the validity, breach, termination or interpretation of this
Agreement.

          1.67 “License” shall mean any license from a Third Party approved by the JSC required
for the Development, Manufacture or Commercialization of any Licensed Product in the Field under
this Agreement.

          1.68 “Licensed Products” shall mean (i) Product Candidates as to which Sanofi has
exercised its Opt-In Rights in accordance with Section 5.4 of the Discovery Agreement, (ii) any
Competing Product that is included in the Collaboration pursuant to Section 2.6(c) below, (iii)
REGN88 (IL-6RmAB) and Delta-like ligand-4(D-ll4) and (iv) ******************** (as defined in the
Discovery Agreement) once included in the Collaboration pursuant to Section 2.11(b) of the
Discovery Agreement.

          1.69 “Major Market Country” shall mean any of the following:
***************************************.

          1.70 “Manufacture” or “Manufacturing” shall mean activities directed to
producing, manufacturing, processing, filling, finishing, packaging, labeling, quality assurance
testing and release, shipping and/or storage of Formulated Bulk Product, Finished Product, placebo
or a comparator agent, as the case may be.

          1.71 “Marketing Approval” shall mean an approval of the applicable Regulatory
Authority necessary for the marketing and sale of a Licensed Product in an indication in the Field
in any country, but excluding any separate Pricing Approval.

          1.72 “Manufacturing Plan” shall mean the manufacturing plan as prepared by the JMC as described in Section 8.5.

          1.73 “Medical Post-Approval Cost” shall mean, for Licensed Product(s) in each country
in the Territory, the product of (a) the number of office-based people supporting (i) the
coordination of Non-Approval Trials, (ii) post-Approval non-clinical pharmacovigilance, (iii) the
maintenance of Approvals, and (iv) Pricing Approvals (with the number and the method of calculating
such number set forth in the applicable Country/Region Commercialization Plan or Global
Commercialization Plan) and (b) the applicable Medical Post-Approval FTE Rate. The calculation of
the number of people in (a) above will be designed to ensure the proper reporting

10

 

and auditing of
such information in accordance with this Agreement. For the avoidance of doubt, the activities of
contract personnel shall be charged as an Out-of-Pocket Cost.

          1.74 “Medical Post-Approval FTE Rate” shall mean, on a Region-by-Region or one or more
Major Market Countries basis in the Territory (determined based on the location of the medical
affairs professional), a rate agreed upon in local currency by the Parties prior to the expected
start of the first Non-Approval Trial in such Region or Major Market Country, as applicable, based
upon the fully burdened cost of medical affairs professionals of pharmaceutical companies in the
Field in the applicable country, such amount to be adjusted as of January 1 of each following
Contract Year by the percentage increase or decrease, if any, in the applicable CPI through June 30
of the prior calendar year. The Medical Post-Approval FTE Rate shall be inclusive of Out-of-Pocket
Costs and other expenses for the employee providing the services, including travel costs and
allocated costs, such as, for example, allocated overhead costs.

          1.75 “Net Sales” shall mean the gross amount invoiced for bona fide arms’ length sales
of Licensed Products in the Field in the Territory by or on behalf of a Party or its Affiliates or
Sublicensees to Third Parties, less the following deductions, determined in accordance with
IAS/IFRS (or GAAP for the US) consistently applied:

          (a) normal and customary trade, cash, quantity and free-goods allowances granted and
taken directly with respect to sales of such Licensed Products;

          (b) amounts repaid or credited by reason of defects, rejections, recalls, returns,
rebates, allowances and billing errors;

          (c) chargebacks and other amounts paid on sale or dispensing of Licensed Products;

          (d) Third Party cash rebates and chargebacks related to sales of Licensed Products, to
the extent allowed;

          (e) retroactive price reductions that are actually allowed or granted;

          (f) compulsory refunds, credits and rebates directly related to the sale of Licensed
Products, accrued, paid or deducted pursuant to agreements (including, but not limited to,
managed care agreements) or government regulations;

          (g) freight, postage, shipment and costs (or wholesale fees in lieu of those costs) and
customs duties incurred in delivering Licensed Products that are separately identified on
the invoice or other documentation;

          (h) sales taxes, excess duties, or other consumption taxes and compulsory payments to
Governmental Authorities or other governmental charges imposed on the sale of Licensed
Products, which are separately identified on the invoice or other documentation; and

          (i) as agreed by the Parties, any other specifically identifiable costs or charges
included in the gross invoiced sales price of such Licensed Product falling within

11

 

categories substantially equivalent to those listed above and ultimately credited to
customers or a Governmental Authority or agency thereof.

Net Sales in currency other than United States Dollars shall be translated into United States
Dollars according to the provisions of Section 9.8 of this Agreement. Sales between the Parties,
or between the Parties and their Affiliates or Sublicensees, for resale, shall be disregarded for
purposes of calculating Net Sales. Any of the items set forth above that would otherwise be
deducted from the invoice price in the calculation of Net Sales but which are separately charged
to, and paid by, Third Parties shall not be deducted from the invoice price in the calculation of
Net Sales. In the case of any sale of a Licensed Product for consideration other than cash, such
as barter or countertrade, Net Sales shall be calculated on the fair market value of the
consideration received as agreed by the Parties. Solely for purposes of calculating Net Sales, if
Sanofi or its Affiliate or Sublicensee sells such Licensed Products in the form of a combination
product containing any Licensed Product and one or more active ingredients (whether combined in a
single formulation or package, as applicable, or formulated or packaged separately but sold
together for a single price in a manner consistent with the terms of this Agreement) (a
“Combination Product”), then prior to the First Commercial Sale of such Combination
Product, the Parties shall agree through the JFC to the value of each component of such Combination
Product and the appropriate method for accounting for sale of such Combination Product. For the
avoidance of doubt, for the purposes of this Agreement, Immunoconjugates (as such term is defined
in the Discovery Agreement) shall not be deemed Combination Products.

     Solely for the purposes of Section 2.6(d) of this Agreement, the term “Licensed Product” as
used in the definition of Net Sales shall refer to Opt-Out Products.

          1.76 “New Information” shall mean any and all ideas, inventions, data, writings,
protocols, discoveries, improvements, trade secrets, materials or other proprietary information not
generally known to the public, which may arise or be conceived or developed by either Party or its
Affiliates, or by the Parties or their Affiliates jointly, during the Term pursuant to this
Agreement, to the extent specifically related to any Licensed Product in the Field, including, without limitation, information and data
included in any Plans or Registration Filings made under this Agreement.

          1.77 “Non-Approval Trials” shall mean any post-marketing surveys, registries and
clinical trials post-first Marketing Approval not intended to gain additional labeled Indications,
but excluding any post-first Marketing Approval clinical trials required by Regulatory Authorities
to maintain Marketing Approvals of existing labeled Indication(s).

          1.78 “Opt-In Right”shall have the meaning set forth in the Discovery Agreement.

          1.79 “Opt-Out Product” shall mean a Licensed Product as to which this Agreement has
been terminated in accordance with Section 19.2. For clarity, an Early Development Opt-Out Product
shall not constitute an Opt-Out Product.

          1.80 “Other Shared Expenses” shall mean those costs and expenses specifically referred
to in Sections 7.6, 12.1(a), 12.2(e), 12.3(b), 13.1(c), 13.3(b), 13.3(d) and 17.1(c).

12

 

          1.81 “Out-of-Pocket Costs” shall mean costs and expenses paid to Third Parties (or
payable to Third Parties and accrued in accordance with GAAP or IAS/IFRS) by either Party and/or
its Affiliates in accordance with a Plan, if applicable.

          1.82 “Party Information” shall mean any and all trade secrets or other proprietary
information, including, without limitation, any proprietary data, inventions, ideas, discoveries
and materials (whether or not patentable or protectable as a trade secret) not generally known to
the public regarding a Party’s or its Affiliates’ technology, products, business or objectives, in
each case, other than New Information, which are disclosed or made available by a Party or such
Party’s Affiliates to the other Party or the other Party’s Affiliates in connection with this
Agreement.

          1.83 “Patent Application” shall mean any application for a Patent.

          1.84 “Patent Rights” shall mean unexpired Patents and Patent Applications.

          1.85 “Patents” shall mean patents and all substitutions, divisions, continuations,
continuations-in-part, reissues, reexaminations and extensions thereof and supplemental protection
certificates relating thereto, and all counterparts thereof in any country in the world.

          1.86 “Person” shall mean and include an individual, partnership, joint venture,
limited liability company, corporation, firm, trust, unincorporated organization and government or
other department or agency thereof.

          1.87 “Phase 3 Trial” shall mean a clinical trial that is designed to gather further
evidence of safety and efficacy of a Licensed Product in the Field (and to help evaluate its
overall risks and benefits) and is intended to support Marketing Approval for a Licensed Product in
the Field in one or more countries in the Territory. A Phase 3 Trial typically follows at least
one dose ranging clinical trial to evaluate further the efficacy and safety of a Licensed Product
in the Field in the targeted patient population and to help define the optimal dose and/or dosing
regimen.

          1.88 “Plan” shall mean any Country/Region Commercialization Plan, Global
Commercialization Plan, Global Development Plan, Initial Development Plan, Manufacturing Plan or
other plan approved through the Committee process relating to the Development, Manufacture or
Commercialization of any Licensed Product in the Field under this Agreement.

          1.89 “Positive Phase 3 Trial Results” shall mean a Phase 3 Trial that meets its
primary end-point as defined in the study protocol for such Phase 3 Trial, and the safety profile
supports continued clinical testing in the applicable Indication and/or filing of an application
for Marketing Approval.

          1.90 “Pre-Launch Marketing Expenses” shall mean, with respect to a Licensed Product,
on a country-by-country basis in the Territory, with respect to each Licensed Product, all
Commercialization expenses to support such Licensed Product in the Field incurred
*************************************************************.

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          1.91 “Pricing Approval” shall mean such approval, agreement, determination or
governmental decision establishing prices for a Licensed Product that can be charged to consumers
and will be reimbursed by Governmental Authorities in countries in the Territory where Governmental
Authorities or Regulatory Authorities of such country approve or determine pricing for pharmaceutical
products for reimbursement or otherwise.

          1.92 “Product Candidate” shall have the meaning set forth in the Discovery Agreement.

          1.93 “Product Trademark” shall mean, with respect to each Licensed Product in the
Field in the Territory, the trademark(s) selected by the JCC and approved by the JSC for use on
such Licensed Product throughout the Territory and/or accompanying logos, slogans, trade names,
trade dress and/or other indicia of origin, in each case as selected by the JCC and approved by the
JSC.

          1.94 “Promotional Materials” shall mean, with respect to each Licensed Product,
promotional, advertising, communication and educational materials relating to such Licensed Product
for use in connection with the marketing, promotion and sale of such Licensed Product in the Field
in the Territory, and the content thereof, and shall include, without limitation, promotional
literature, product support materials and promotional giveaways.

          1.95 “Quarter” or “Quarterly” shall refer to a calendar quarter, except that
the first (1st) Quarter shall commence on the Effective Date and extend to the end of the
then-current calendar quarter and the last calendar quarter shall extend from the first day of such
calendar quarter until the effective date of the termination or expiration of the Agreement.

          1.96 “Regeneron Intellectual Property” shall mean the Regeneron Patent Rights and any
Know-How of Regeneron or any of its Affiliates.

          1.97 “Regeneron Know-How” shall mean any and all Know-How now or hereafter during the
term of the Discovery Program or the Collaboration owned by, licensed to or otherwise held by
Regeneron or any of its Affiliates (other than Sanofi Know-How and Know-How included in Joint
Inventions) with the right to sublicense the same that relate to a Licensed Product in the Field
and are necessary or useful for the Development, Manufacture or Commercialization of a Licensed
Product in the Field, including, without limitation, New Information.

          1.98 “Regeneron Patent Rights” shall mean those Patent Rights which, (a) at the
Effective Date or at any time thereafter during the Term, are owned by, licensed to or otherwise
held by Regeneron or any of its Affiliates (other than Sanofi Patent Rights and Patent Rights included in Joint Inventions), with the
right to license or sublicense the same, and (b) include at least one Valid Claim which would be
infringed by the Development, Manufacture or Commercialization of a Licensed Product in the Field,
but only to such extent.

          1.99 “Region” shall mean such countries or group of countries as determined by the
JCC.

14

 

          1.100 “Registration Filing” shall mean the submission to the relevant Regulatory
Authority of an appropriate application seeking any Approval, and shall include, without
limitation, any IND or Marketing Approval application in the Field.

          1.101 “Regulatory Authority” shall mean any federal, national, multinational, state,
provincial or local regulatory agency, department, bureau or other governmental entity anywhere in
the world with authority over the Development, Manufacture or Commercialization of any Licensed
Product in the Field under this Agreement. The term “Regulatory Authority” includes, without
limitation, the FDA, the EMEA and the Japanese Ministry of Health, Labour and Welfare.

          1.102 “Reporting Country/Region” shall mean each Major Market Country, and each other
country or Region for which a Country/Region Commercialization Committee has been established by
the JCC.

          1.103 “Rest of World” or “ROW” shall mean all Rest of World Countries.

          1.104 “Rest of World Country” shall mean any country in the Territory other than the
United States.

          1.105 “ROW CPI” shall mean the “EU15 CPI” (or its successor equivalent index), which
is published monthly and available via The Bloomberg Professional, as published by Bloomberg L.P.

          1.106 “Sales Force Cost” shall mean, for Licensed Product(s) in each country in the
Territory, the product of (a) the number of detailing people (with the number and the method of
calculating such number set forth in the applicable Country/Region Commercialization Plan or Global
Commercialization Plan), and (b) **********************************. The calculation of the number
of detailing people in (a) above will be based on ****************************************************. For the avoidance of doubt, the
activities of contract personnel, including contract Sales Force, shall be charged as Out-of-Pocket
Costs.

          1.107 “Sales Force FTE Rate” shall mean, on a Region-by-Region or one or more Major
Market Countries basis (determined based on the location of the sales representative), a rate
agreed upon in local currency by the Parties at least eighteen (18) months prior to the Anticipated
First Commercial Sale in the Region or Major Market Country, as applicable, based upon the fully
burdened cost of sales representatives of pharmaceutical companies in the Field in the applicable
country, and including an allocation of regional and country sales force management cost, to be
approved six (6) months prior to the first Commercial Sale, such amount to be adjusted as of
January 1 of each following Contract Year by the percentage increase or decrease, if any, in the
applicable CPI through June 30 of the prior calendar year. The Sales Force FTE Rate shall be
inclusive of Out-of-Pocket Costs and other expenses for the employee providing the services,
including travel costs, information systems and allocated costs, such as, for example, allocated
overhead costs.

15

 

          1.108 “Sanofi Intellectual Property” shall mean the Sanofi Patent Rights and the
Sanofi Know-How.

          1.109 “Sanofi Know-How” shall mean any and all Know-How now or hereafter during the
term of the Discovery Program or the Collaboration owned by, licensed to or otherwise held by
Sanofi or its Affiliates (other than Regeneron Know-How and Know-How included in Joint Inventions)
with the right to sublicense the same that relate to a Licensed Product in the Field and are
necessary or useful for the Development, Manufacture or Commercialization of a Licensed Product in
the Field, including, without limitation, New Information.

          1.110 “Sanofi Patent Rights” shall mean those Patent Rights which, (a) at the
Effective Date or at any time thereafter during the Term, are owned by, licensed to or otherwise
held by Sanofi or any of its Affiliates (other than Regeneron Patent Rights and Patent Rights
included in Joint Inventions), with the right to license or sublicense the same, and (b) include at
least one Valid Claim which would be infringed by the Development, Manufacture or Commercialization
of a Licensed Product in the Field, but only to such extent.

          1.111 “Sanofi Stock Purchase Agreement” means the Stock Purchase Agreement dated as of
the Effective Date by and between Sanofi Amerique, Aventis LLC and Regeneron.

          1.112 “Shared Commercial Expenses” shall mean the sum of the following items, in each case to the extent directly attributable to
Commercialization of Licensed Products in the Field in the Territory in accordance with an approved
Country/Region Commercialization Plan or Global Commercialization Plan:

          (a) ********************************** to cover the cost of distribution, freight,
insurance and warehousing, related to the sale of Licensed Products in the Field in the
Territory, less any amount deducted from Net Sales pursuant to clause (g) of the definition
of Net Sales;

          (b) bad debt attributable to Licensed Products in the Field sold in the Territory;

          (c) Sales Force Cost;

          (d) Medical Post-Approval Cost;

          (e) Out-of-Pocket Costs related to (i) the marketing, advertising and/or promotion of
Licensed Products in the Field in the Territory (including, without limitation, pricing
activities, commercial pharmacovigilance, educational expenses, advocate development
programs and symposia and Promotional Materials), (ii) market research for Licensed Products
in the Field in the Territory and (iii) the preparation of training and communication
materials for Licensed Products in the Field in the Territory;

          (f) a portion of Out-of-Pocket Costs agreed upon by the Parties related to the
marketing, advertising and promotion of Licensed Products in the Field in the

16

 

Territory (including, without limitation, educational expenses, advocate development programs and
symposia, and promotional materials) to the extent such marketing, advertising and promotion
relate to both Licensed Products and other products developed or commercialized by Sanofi or
its Affiliates as agreed upon in an approved Global Commercialization Plan or Country/Region
Commercialization Plan;

          (g) Out-of-Pocket Costs related to Non-Approval Trials for Licensed Products in the
Field in the Territory, including, without limitation, the Out-of-Pocket Cost of clinical
research organizations, investigator and expert fees, lab fees and scientific service fees,
the Out-of-Pocket Cost of shipping clinical supplies to centers or disposal of clinical
supplies, in each case, to the extent not included in Commercial Supply Cost;

          (h) Out-of-Pocket Costs related to Pricing Approvals and the maintenance of all
Approvals directly related to the Commercialization of Licensed Products in the Field in the
Territory;

          (i) Commercial Overhead Charge;

          (j) Pre-Launch Marketing Expenses;

          (k) Out-of-Pocket Costs related to regulatory affairs activities, other than activities
to secure Registration Filing of indications and line extensions; and

          (l) any other costs or expenses directly related to the Commercialization of a Licensed
Product after First Commercial Sale of such Licensed Product and not included in clauses (a)
through (k) above.

     The foregoing shall not include any costs which have been included in Development Costs. For
clarity, it is the intent of the Parties that costs and headcount included in the foregoing will be
fairly allocated to the Licensed Products in the Field in the Territory (to the extent that any
Shared Commercial Expense is attributable, in part, to products or activities other than the
Licensed Products in the Field in the Territory) and, in each case, will only be included once in
the calculation of the Quarterly True-Up.

          1.113 “Shared Phase 3 Trial Costs” shall mean Development Costs associated with Phase
3 Trials of any Licensed Product incurred after the receipt of first Positive Phase 3 Trial Results
for such Licensed Product.

          1.114 “Sublicensee” shall mean a Third Party or an Affiliate to whom Sanofi will have
granted a license or sublicense under Sanofi’s rights pursuant to Section 4.3 to Commercialize
Licensed Products in the Field in the Territory. For the avoidance of doubt, a “Sublicensee” will
include a Third Party to whom Sanofi will have granted the right to distribute Licensed Products in
the Field wherein such distributor pays to Sanofi a royalty (or other amount) based upon the
revenues received by the distributor for the sale (or resale) of Licensed Products by such
distributor.

17

 

          1.115 “Target” shall mean any gene, receptor, ligand or other molecule (a) associated
with a disease activity that may be modified by direct interaction with a Licensed Product or (b)
to which a Licensed Product binds.

          1.116 “Terminated Licensed Product”shall mean a Licensed Product as to which this
Agreement has been terminated in accordance with its terms in accordance with Article XIX, and
shall include any Opt-Out Product.

          1.117 “Termination Notice Period” shall mean the Sanofi Termination Notice Period or
the Regeneron Termination Notice Period, as applicable.

          1.118 “Territory” shall mean all the countries and territories of the world.

          1.119 “Third Party” shall mean any Person other than Sanofi or Regeneron or any
Affiliate of either Party.

          1.120 “United States,” “US” or “U.S.” shall mean the United States of
America (including its territories and possessions) and Puerto Rico.

          1.121 “US CPI” shall mean the Consumer Price Index — All Urban Consumers published by
the United States Department of Labor, Bureau of Statistics (or its successor equivalent index).

          1.122 “Valid Claim” shall mean (a) a claim of an issued and unexpired Patent
(including the term of any patent term extension, supplemental protection certificate, renewal or
other extension) which has not been held unpatentable, invalid or unenforceable in a final decision
of a court or other Governmental Authority of competent jurisdiction from which no appeal may be or
has been taken, and which has not been admitted to be invalid or unenforceable through reissue,
re-examination, disclaimer or otherwise; or (b) a claim of a Patent Application, which claim has
been pending less than five (5) years from the original priority date of such claim in a given
jurisdiction, unless or until such claim thereafter issues as a claim of an issued Patent (from and
after which time the same shall be deemed a Valid Claim subject to paragraph (a) above).

          1.123 Additional Definitions. Each of the following definitions is set forth in the
Sections (or Schedules) of this Agreement indicated below:

	 	 	 
	DEFINITION	 	SECTION/SCHEDULE
	Acquired Entity
	 	2.6(c)
	Acquiring Party
	 	2.6(c)
	Agreement
	 	Preamble
	Alliance Manager
	 	3.2(a)
	Annual True-Up
	 	SCHEDULE 2
	Applicable ROW Percentages
	 	SCHEDULE 2
	Budget Dispute
	 	Section 3.11(b)
	Collaboration
	 	Preamble
	Collaboration Purpose
	 	3.1(b)

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	DEFINITION	 	SECTION/SCHEDULE
	Combination Product
	 	1.76
	Cost
	 	SCHEDULE 1
	Damages
	 	17.1(a)
	Default Interest Rate
	 	9.9
	Development Balance
	 	SCHEDULE 2
	Discovery Agreement
	 	Preamble
	Disputed Budget
	 	Section 3.11(b)
	Early Development Opt-Out Product
	 	5.6
	Effective Date
	 	Preamble
	Excluded Rights
	 	4.3
	Expert Panel
	 	10.4(a)
	First Year
	 	5.3
	Force Majeure
	 	ARTICLE XVIII
	Global Development Budget(s)
	 	5.3
	Governance Dispute
	 	10.2
	Incomplete Activity
	 	5.3
	Indemnified Party
	 	17.2
	Indemnifying Party
	 	17.2
	JCC
	 	3.1(a)
	JDC
	 	3.1(a)
	JFC
	 	3.1(a)
	JMC
	 	3.1(a)
	Joint Invention
	 	12.1(b)
	JSC
	 	3.1(a)
	Lead Litigation Party
	 	13.1(c)
	Manufacturing Cost
	 	SCHEDULE 1
	Manufacturing Notice
	 	8.3(a)
	Manufacturing Plan
	 	8.5
	Marketing Guidelines
	 	3.4(b)(vi)
	Maximum Regeneron Effort
	 	6.5(e)(i)
	Modified Clause
	 	20.7
	Non-Acquiring Party
	 	2.6(c)
	Non-Approval Trials
	 	6.2(h)
	Non-Incurred Amount
	 	5.3
	Opt-Out Partner
	 	2.6(d)
	Opt-Out Product Notice
	 	2.6(c)
	OverPaying Party
	 	Section 13.3(e)
	Party(ies)
	 	Preamble
	Patent Jurisdictions
	 	12.2(a)
	POC Principal Party
	 	5.2
	POC Time
	 	5.2
	Post-POC Principal Party
	 	5.2
	Publishing Party
	 	16.3
	Quarterly True-Up
	 	SCHEDULE 2
	Regeneron
	 	Preamble

19

 

	 	 	 
	DEFINITION	 	SECTION/SCHEDULE
	Regeneron Commitment Level
	 	6.5(e)(i)
	Regeneron Early Development Opt-Out Right
	 	5.6
	Regeneron Early Opt-Out Notice
	 	5.6
	Regeneron Indemnitees
	 	17.1(a)
	Regeneron Profit Split
	 	SCHEDULE 2
	Regeneron Reimbursement Amount
	 	SCHEDULE 2
	Regeneron Sole Inventions
	 	12.1(a)
	Regeneron Termination Notice Period
	 	19.2(b)
	Reimbursement Payment
	 	SCHEDULE 2
	Required Divestiture Notice Period
	 	2.6(c)
	Rest of World Profit Split
	 	SCHEDULE 2
	Royalty Term
	 	9.3
	ROW Profit Split
	 	SCHEDULE 2
	ROW Profit Split Annual True-Up
	 	SCHEDULE 2
	Sanofi
	 	Preamble
	Sanofi Amerique
	 	Preamble
	Sanofi Indemnitees
	 	17.1(b)
	Sanofi Parent
	 	Preamble
	Sanofi Sole Inventions
	 	12.1(a)
	Sanofi Termination Notice Period
	 	19.2(a)
	SDEA
	 	7.4
	Shared Phase 3 Trial Costs Balance
	 	SCHEDULE 2
	Sole Developer
	 	2.6(d)
	Sole Inventions
	 	12.1(a)
	Succeeding Year(s)
	 	5.3
	Target Labeling
	 	7.2(d)
	Target ROW Profit Split
	 	SCHEDULE 2
	Technical Development Matter
	 	10.2
	Term
	 	19.1(a)
	Third Party
	 	2.6(c)
	Third Party Acquisition
	 	2.6(c)
	U.S. Profit Split
	 	SCHEDULE 2
	US Profits
	 	SCHEDULE 2
	VelocImmune Royalties
	 	Section 13.3(e)
	Working Group
	 	3.1(a)

ARTICLE II

COLLABORATION

          2.1 Scope of Collaboration . Upon and subject to terms and conditions of this
Agreement, the Parties will cooperate in good faith to Develop, Manufacture and Commercialize
Licensed Products in the Field in the Territory in such a manner so as to optimize the commercial
potential of each Licensed Product. The Parties shall establish various Committees as set forth in
Article III of this Agreement to oversee and/or coordinate the Development, Manufacture and
Commercialization of Licensed Products in the Field in the Territory, and each

20

 

Party shall, subject
to the terms and conditions set forth in Article XVI, provide (or cause its Affiliates to provide)
to any relevant Committee any necessary Party Information, New Information and such other
information and materials as may be reasonably required for the Parties to operate effectively and efficiently under and in
accordance with the terms and conditions of this Agreement.

          2.2 Compliance With Law. Both Sanofi and Regeneron, and their respective Affiliates,
shall perform their obligations under this Agreement in accordance with applicable Law. No Party
or any of its Affiliates shall, or shall be required to, undertake any activity under or in
connection with this Agreement which violates, or which it believes, in good faith, may violate,
any applicable Law.

          2.3 Further Assurances and Transaction Approvals. Upon the terms and subject to the
conditions hereof, each of the Parties will use Commercially Reasonable Efforts to (a) take, or
cause to be taken, all actions necessary, proper or advisable under applicable Laws or otherwise to
consummate and make effective the transactions contemplated by this Agreement, (b) obtain from the
requisite Governmental Authorities any consents, licenses, permits, waivers, approvals,
authorizations or orders required to be obtained or made by such Party in connection with the
authorization, execution and delivery by such Party of this Agreement and the consummation by such
Party of the transactions contemplated by this Agreement and (c) make all necessary filings, and
thereafter make any other advisable submissions, with respect to this Agreement and the
transactions contemplated by this Agreement required to be made by such Party under applicable
Laws. The Parties will cooperate with each other in connection with the making of all such
filings. Each Party will furnish to the other Party all information in its possession or under its
control required for any applicable or other filing to be made pursuant to the rules and
regulations of any applicable Laws in connection with the transactions contemplated by this
Agreement.

          2.4 Compliance with Third Party Agreements. Each Party agrees to comply with the
obligations set forth in (a) the Licenses to which it is a party and to notify the other Party of
any terms or conditions in any such License with which such other Party is required to comply as a
licensee or sublicensee, as the case may be, and (b) any other material agreement, including any
sublicense under a License referenced in subsection (a) above, to which it is a party and that is
related to the Collaboration, including, without limitation, any obligations to pay royalties, fees
or other amounts due thereunder. Neither Party may terminate or amend any License or any other
material agreement entered into pursuant to a Plan without the prior written consent of the other
Party, such consent not to be unreasonably withheld or delayed, if the amendment or termination
imposes any material liability or restriction on either Party with respect to the Development,
Manufacture or Commercialization of Licensed Products in the Field in the Territory.

          2.5 Plans. The Parties shall undertake all Development and Commercialization
activities under this Agreement solely in accordance with the Committee approved Plans. The
Parties may agree to amend all Plans and budgets from time to time as circumstances may require.

          2.6
Limitation on Exercise of Rights Outside of Collaboration.

21

 

          (a) Non-Compete. Without limitation of and in addition and subject to Section
2.8 of the Discovery Agreement, during the Term, except as set forth in this Agreement or
Section 2.8 of the Discovery Agreement, neither Party nor any of its Affiliates, either
alone or through any Third Party, shall Develop or Commercialize any Competing Product.

          (b) Regeneron Sole Development. If Regeneron presents a proposal to the JDC to
undertake additional clinical trials not contemplated in a Global Development Plan to
support a Licensed Product in the Field and the JDC fails to approve the proposal within the
timeframe established by the JDC pursuant to Section 5.5, then Regeneron may, at its option
and at its sole expense, conduct such additional clinical trial(s) outside the scope of the
applicable Global Development Plan; provided, however, Regeneron must first present the
proposed protocols and clinical trial designs to Sanofi for approval, such approval not to
be unreasonably withheld or delayed and, for other than Non-Approval Trials, shall also
present to Sanofi the related budgets for Clinical Supply Costs and Out-of-Pocket Costs and
applicable FTE costs (provided that such budgets shall be provided for informational
purposes only and may not be used to disapprove such protocols and designs). Regeneron
shall also provide to Sanofi drug safety data from such additional clinical trials in
accordance with Section 7.4. The Sanofi representatives on the JDC may disapprove any such
protocols or clinical trial designs for reasons of safety or Sanofi reasonably believes that
the development as described in this Section 2.6(b) would have a material adverse effect on
the overall development strategy for the Licensed Product and/or the commercial viability of
such License Product, including the magnitude of sales for such Licensed Product. If, in
compliance with this Section 2.6(b), Sanofi does not approve any such protocols or clinical
trial designs for reasons as described herein, Regeneron may not proceed with the proposed
clinical trials unless Regeneron disputes such disapproval and until the dispute has been
resolved, as provided in Section 3.11(b) and, if necessary, Section 10.4, in Regeneron’s
favor. In the event that Regeneron conducts any such additional clinical trials, all
results, Know-How and Patent Rights generated in or arising from any such clinical trial
shall be subject to the grants of rights pursuant to Article IV of this Agreement. For the
avoidance of doubt, no consideration or reimbursement shall be paid to Regeneron with
respect to the conduct of any such additional clinical trials; provided, however, that if
the Parties subsequently agree to commence a further clinical trial based on the results of
such additional clinical trial(s) or data is used from such additional clinical trial(s) to
support an Approval in the Territory, then Sanofi shall be required to reimburse Regeneron
for ************* of the actual Out-of-Pocket Costs and Clinical Supply Costs and
applicable FTE costs incurred in connection with the conduct of such additional clinical
trial(s) that are consistent with the budgets provided to Sanofi pursuant to this Section
2.6(b) and the other terms of this Agreement. Publication of any results or data obtained
in conducting the additional clinical trial(s) allowed under this Section 2.6(b) shall be
subject to Article XVI.

          (c) Company Acquisitions. Notwithstanding Section 2.6(a), if as the result of
an acquisition of a Third Party (such acquisition a “Third Party Acquisition) by a
Party or one or more of its Affiliates (the “Acquiring Party”), the Acquiring Party

22

 

acquires rights to a product that is a Competing Product (the “Acquired Competing
Product”) to a Licensed Product (the “Competing Licensed Product”), the
Acquiring Party, at its sole discretion, shall do one of the following: (W) present a
proposal to the JDC to include the Acquired Competing Product in the Collaboration in
accordance with Section 2.6(c)(i); (X) deliver to the other Party (the “Non-Acquiring
Party”) a termination notice, pursuant to Section 19.2(a) or 19.2 (b), as appropriate,
and Section 2.6(c)(ii), with regard to the Competing Licensed Product; or (Y) transfer its
rights in the Acquired Competing Product to a Third Party pursuant to Section 2.6(c)(iii).

          (i) Proposal for Inclusion. If the Acquiring Party chooses this
alternative, within ten (10) Business Days after the closing of such Third Party
Acquisition, the Acquiring Party shall present a proposal to the JDC to include such
Acquired Competing Product in the Collaboration based on the terms of this
Agreement. As part of such presentation, the Acquiring party shall provide the JDC
with all information with respect to such Acquired Competing Product reasonably
available to the Acquiring Party and material to a decision by the Non-Acquiring
Party’s representatives on the JDC as to whether to approve the inclusion of such
Acquired Competing Product in the Collaboration. The JDC shall, on or before the
date which is twenty (20) Business Days after the closing of such Third Party
Acquisition, decide whether to approve the inclusion of such Acquired Competing
Product in the Collaboration under the terms of this Agreement. If the JDC timely
approves the inclusion of such Acquired Competing Product in the Collaboration, then
upon the closing of such Third Party Acquisition the Acquired Competing Product
shall automatically be included in the Collaboration as a Licensed Product
hereunder. If the JDC does not approve such inclusion, the Acquiring Party shall
elect whether to deliver to the Non-Acquiring Party a termination notice, pursuant
to Section 19.2(a) or 19.2 (b), as appropriate, and Section 2.6(c)(ii), with regard
to the Competing Licensed Product or transfer its rights to the Acquired Competing
Product to a Third Party (without any consideration or payment to the Non-Acquiring
Party in accordance with Section 2.6(c)(iii) below).

          (ii) Termination of Licensed Product. If the Acquiring Party chooses
this alternative, the Acquiring Party shall deliver to the Non-Acquiring Party,
within ten (10) Business Days after the decision of the JDC not to include the
Acquired Competing Product in the Collaboration pursuant to Section 2.6(c)(i), a
termination notice pursuant to Section 19.2(a) or 19.2(b), as applicable, with
respect to the Competing Licensed Product (the “Opt-Out Product Notice”).
The provisions of Section 19.2(a) or 19.2(b), as applicable, and the provisions of
Sections 19.7, 19.8 and Schedule 4 or 5, as applicable, shall then apply to such
Competing Licensed Product. For the avoidance of doubt, such Competing Licensed
Product shall then be an Opt-Out Product, and notwithstanding any other provision of
this Agreement, the Acquiring Party shall be deemed (without any requirement of notice to the Non-Acquiring Party) to have irrevocably ceded
all decision-making authority with respect to such Opt-Out Product to the
Non-Acquiring Party. In addition, if such Opt-Out Product is being marketed and
sold

23

 

at the time of the closing of the Third Party Acquisition, then during the
Sanofi Termination Notice Period or Regeneron Termination Notice Period, as
applicable, the following shall apply:

(1) In any Quarter in which the U.S. Profits are positive, the U.S. Profit
Split shall be zero percent (0%) to the Acquiring Party and one hundred
percent (100%) to the Non-Acquiring Party, and in any Quarter in which the
ROW Profits are positive, the ROW Profit Split shall be zero percent (0%) to
the Acquiring Party and one hundred percent (100%) to the Non-Acquiring
Party.

(2) In any Quarter, in which U.S. Profits are negative, the U.S. Profit
Split shall be one hundred percent (100%) to the Acquiring Party and zero
percent (0%) to the Non-Acquiring Party, and in any Quarter in which ROW
Profits are negative, the ROW Profit Split shall be one hundred percent
(100%) to the Acquiring Party and zero percent (0%) to the Non-Acquiring
Party.

          (iii) Transfer of Rights. If the Acquiring Party chooses this
alternative, the Acquiring Party shall commit in writing to the Non-Acquiring Party,
within ten (10) Business Days after the closing of such Third Party Acquisition, to
license or otherwise transfer rights to such Acquired Competing Product to a Third
Party (without any consideration or payment to the Non-Acquiring Party) and/or cease
all development, manufacturing and/or commercialization, as applicable, of such
Acquired Competing Product within six (6) months after the closing of the Third
Party Acquisition, and shall do so within such six (6) month period.

          (iv) Required Divestiture of Licensed Product. Notwithstanding any of
the foregoing in this Section 2.6(c), in the event the Acquiring Party believes,
based on the written advice of its counsel, that it is required by Law to divest its
interest either in the Acquired Competing Product or the Competing Licensed Product,
the Acquiring Party may terminate this Agreement with respect to such Competing
Licensed Product pursuant to Section 19.2(a) or 19.2 (b), as appropriate, Section
2.6(c)(ii) and this Section 2.6(c)(iv), with regards to the Competing Licensed
Product, or transfer its interest in the Competing Licensed Product pursuant to
Section 2.6(c)(iii). If the Acquiring Party terminates this Agreement with respect
to the Competing Licensed Product pursuant to this Section 2.6(c)(iv), it shall give
the Non-Acquiring Party the maximum advance notice (up to twelve (12) months) of
termination consistent with such divestiture requirement imposed by Law (the
“Required Divestiture Notice Period”), following which the provisions of
2.6(c)(ii) shall apply and the Competing Licensed Product shall be an Opt-Out
Product. During this period, the Acquiring
Party will reasonably cooperate (at the Acquiring Party’s sole cost and
expense) with the Non-Acquiring Party to enable the Non-Acquiring Party to assume,
within the Required Divestiture Notice Period, the continued Development,

24

 

Manufacture and Commercialization of such Opt-Out Product in the Field in the
Territory. The Acquiring Party shall also be responsible for, and shall promptly
pay upon demand, all reasonable costs and expenses incurred by the Non-Acquiring
Party in assuming such continued Development, Manufacture and Commercialization of
such Opt-Out Product to the extent such costs and expenses, other than capital
investments, would not have been incurred and/or would have been paid by the
Acquiring Party, absent such Acquiring Party’s termination with respect to such
Opt-Out Product pursuant to Section 19.2(a) or (b). For the avoidance of doubt, if
the Required Divestiture Notice Period is less than the twelve (12) months required
by Section 19.2, the Acquiring Party shall have continuing payment obligations
(though no performance obligations beyond those described above) to the
Non-Acquiring Party with respect to such Opt-Out Product for the entire Sanofi
Termination Notice Period (if Sanofi is the Acquiring Party) or Regeneron
Termination Notice Period (if Regeneron is the Acquiring Party).

          (d) Subject to the further provisions of this Section 2.6(d), in the case of any
Opt-Out Product, the non-terminating Party (the “Sole Developer”) shall have the
right to Develop and Commercialize such Opt-Out Product, unless such Opt-Out Product is (or
becomes) a Competing Opt-Out Product, in which case the Sole Developer may not (either
directly or through an Affiliate or Third Party), Develop or Commercialize such Competing
Opt-Out Product for a period of ******** following the date it becomes a Competing Opt-Out
Product (or, if shorter, such period ending on the date such Competing Opt-Out Product
ceases to be a Competing Opt-Out Product), unless otherwise agreed by the terminating Party
(the “Opt-Out Partner”). If an Opt-Out Product is Commercialized by the Sole
Developer (either directly or through an Affiliate or Third Party) in compliance with this
Section 2.6(d), then the Sole Developer shall pay the Opt-Out Partner royalties based on Net
Sales of such Opt-Out Product and the stage of Development of the Licensed Product at the
time it became an Opt-Out Product, at the royalty rate(s) described on Exhibit A.
Notwithstanding the foregoing or any other provision of this Agreement, in the case of any
Opt-Out Product, including any Competing Opt-Out Product, resulting from termination of this
Agreement with respect to a Licensed Product pursuant to Section 19.2 in the circumstances
described in Section 2.6(c), the Sole Developer shall have no obligation either to delay
Developing or Commercializing, or to pay royalties with respect to, such Opt-Out Product.

          (e) Clinical Trials for Combination Products. Notwithstanding anything in this
Section 2.6(e) to the contrary, each Party and/or its respective Affiliates shall be
entitled to (i) initiate, sponsor and/or conduct a clinical trial and/or (ii) participate,
directly or indirectly, whether through the provision of funds, grants or otherwise, in any
clinical trial, initiated, sponsored and/or conducted by any Third Party, in each of the
foregoing cases with respect to the combination of any Party’s (or its Affiliate’s) product,
together with any Competing Product that has been granted a Marketing Approval for at
least one Indication in the applicable country, unless (A) a Licensed Product Developed
under this Agreement has been granted a Marketing Approval in the applicable country for use
in combination with such Party’s (or its Affiliate’s) product in the same

25

 

Indication(s) as
the one to be studied in the intended clinical trial with the Competing Product which is not
approved in such Indication or (B) both the Competing Product and a Licensed Product
Developed under this Agreement have been granted a Marketing Approval in the applicable
country for use in combination with such Party (or its Affiliate’s) product as the same
Indication to be studied in the intended clinical trial with the Competing Product and the
relevant labeling of both the Licensed Product and the Competing Product for such Indication
is substantially similar. For any combination study with a Competing Product covered by
this Section 2.6(e), the applicable Party shall notify the other Party prior to initiating
such trial, such notice to include a brief synopsis of the protocol and a description of the
Party’s (or its Affiliate’s) role(s) and responsibilities in connection with the study.
Further, for any combination study with a Competing Product covered by this Section 2.6(e),
each Party shall promptly provide the other Party with available results of such combination
study, unless such disclosure is prohibited by Law or contract. Each Party and/or its
Affiliates shall be entitled to use data from clinical trials permitted by this Section
2.6(e) to promote the combination of such Party product together with such Competing
Product, unless a Licensed Product Developed has been granted a Marketing Approval in the
applicable country for use in combination with such Third Party product, in the same
Indication. Neither Party nor its respective Affiliates shall receive any compensation or
other payments (either in cash or in kind) based on the development, promotion, or sale of a
Competing Product. Neither Party will intentionally delay the commencement, enrollment or
completion of a clinical study of a Licensed Product as a result of any ongoing or pending
clinical trial permitted by this Section 2.6(e). For the avoidance of doubt, neither Party
nor its respective Affiliates shall use or disclose any Party Information or New Information
subject to the confidentiality provisions of Article XVI in connection with any of the
activities described in this Section 2.6(e).

ARTICLE III

MANAGEMENT

     3.1 Committees/Management.

          (a) The Parties agree to establish, for the purposes specified herein, a Joint Steering
Committee (the “JSC”), a Joint Development Committee (the “JDC”), a Joint
Commercialization Committee (the “JCC”), CRCCs to the extent provided in Section
3.5, and such other commercialization sub-committee as JCC shall deem to be appropriate, a
Joint Manufacturing Committee (“JMC”), a Joint Finance Committee (the “JFC”)
and such other Committees as the Parties deem appropriate. The JSC, JDC, JFC and JMC shall
each be established within thirty (30) days after the Effective Date. The JCC shall be
established at least two (2) years prior to the anticipated filing date for Marketing
Approval for the first Licensed Product under this Agreement. The roles and
responsibilities of each Committee are set forth in this Agreement (or as may be
determined by the JSC for Committees established in the future and not described herein) and
may be further designated by the JSC. From time to time, each Committee may establish
working groups (each, a “Working Group”) to oversee particular projects or

26

 

activities, and each such Working Group shall be constituted and shall operate as the
Committee which establishes the Working Group determines.

          (b) Each of the Committees and the Executive Officers shall exercise its
decision-making authority hereunder in good faith and in a commercially reasonable manner
for the purpose of optimizing the commercial potential of and financial returns from the
Licensed Products in the Field in the Territory consistent with Commercially Reasonable
Efforts and without regard to any other pharmaceutical product being developed or
commercialized in the Field by or through a Party or any of its Affiliates (the
“Collaboration Purpose”). The Parties acknowledge and agree that none of the
Committees or the Executive Officers shall have the power to amend any of the terms or
conditions of this Agreement, other than by mutual agreement of the Parties as set forth in
Section 20.5.

     3.2 Joint Steering Committee.

          (a) Composition and Purpose. The JSC shall have overall responsibility for the
oversight of the Collaboration. The purpose of the JSC shall be (i) to review and approve
the overall strategy for an integrated worldwide Development program for each Licensed
Product, including the Manufacture of Licensed Products in the Field for use in activities
under the Plans and for the Commercialization of Licensed Products in the Field in the
Territory; (ii) to review the efforts of the Parties in performing their responsibilities
under the Plans and (iii) to oversee the Committees and resolve matters pursuant to the
provisions of Section 3.11 below on which such Committees are unable to reach consensus.
The JSC shall be composed of at least three (3) senior executives of each Party; provided
that the total number of representatives may be changed upon mutual agreement of the Parties
(so long as each Party has an equal number of representatives). In addition, each Party
shall appoint a senior representative who possesses a general understanding of clinical,
regulatory, manufacturing and marketing issues to act as its Alliance Manager (“Alliance
Manager”) to the JSC. Each Alliance Manager shall be charged with creating and
maintaining a collaborative work environment within and among all Committees and providing
single-point communication for seeking consensus both within the respective Party’s
organization and with the other Party’s organization.

          (b) Specific Responsibilities. In addition to its overall responsibility for
overseeing the Collaboration, the JSC shall in particular (i) annually review and approve
the Global Development Plan(s) if any, Manufacturing Plan(s), Global Commercialization
Plan(s) and Country/Region Commercialization Plan(s); (ii) at least semi-annually review the
efforts of the Parties in performing their respective
Development and Commercialization activities under the then-effective Plans; (iii)
attempt in good faith to resolve any disputes referred to it by any of the Committees and
provide a single-point of communication for seeking consensus regarding key global strategy
and Plan issues; (iv) establish sub-committees of the JSC, as the JSC deems appropriate and
(v) consider and act upon such other matters as are specifically assigned to the JSC under
this Agreement or otherwise agreed by the Parties.

27

 

     3.3 Joint Development Committee.

          (a) Composition and Purpose. The purpose of the JDC shall be (i) to advise the
JSC on the strategy for the worldwide Development of each Licensed Product in the Field;
(ii) to develop (or oversee the development of), review and annually update and present to
the JSC for approval the Global Development Plan(s) (and related Global Development
Budget(s)) and (iii) to oversee the implementation of the Global Development Plan(s) and the
Development operational aspects of the Collaboration. The JDC shall be composed of at least
three (3) senior executives of each Party; provided that the total number of representatives
may be changed upon mutual agreement of the Parties (so long as each Party has an equal
number of representatives).

          (b) Specific Responsibilities. In particular, the JDC shall be responsible
for:

          (i) advising the JSC on the overall global Development strategy for each
Licensed Product in the Field;

          (ii) developing (or overseeing the development of), and updating at least
annually, the Global Development Plan(s) (and related Global Development Budget(s)),
as described in Sections 5.2 and 5.3, for final approval by the JSC;

          (iii) reviewing and overseeing the implementation of, and compliance with, the
Global Development Plan(s) (including the Global Development Budget(s));

          (iv) developing forecasts for Clinical Supply Requirements to enable the timely
preparation of the Manufacturing Plan;

          (v) overseeing clinical and regulatory matters pertaining to Licensed Products
in the Field arising from the Plans, and reviewing and approving protocols,
statistical analysis plans, clinical study endpoints, clinical methodology and
monitoring requirements for clinical trials of Licensed Products in the Field as
contemplated under the Global Development Plan(s) and for Non-Approval Trials;

          (vi) reviewing and approving proposed target Licensed Product labeling and
reviewing and, to the extent set forth herein, approving proposed changes to product
labeling with respect to Licensed Products in the Field in accordance with Section
7.2;

          (vii) developing a target profile for each Licensed Product;

          (viii) facilitating an exchange between the Parties of data, information,
material and results relating to the Development of Licensed Products in the Field;

28

 

          (ix) formulating a life-cycle management strategy for Licensed Products in the
Field and evaluating new opportunities for new formulations, delivery systems and
improvements in concert with the JCC;

          (x) establishing a regulatory Working Group responsible for overseeing,
monitoring and coordinating the submission of Registration Filings in countries in
the Territory, including coordinating material communications, filings and
correspondence with Regulatory Authorities in the Territory in connection with the
Licensed Products in the Field;

          (xi) establishing a Working Group responsible for overseeing all basic research
activities for Licensed Products in the Field conducted under the Global Development
Plan(s); and

          (xii) considering and acting upon such other matters as specifically assigned
to the JDC under this Agreement or by the JSC.

     3.4 Joint Commercialization Committee.

          (a) Composition and Purpose. The purpose of the JCC shall be to develop and
propose to the JDC and JSC the strategy for the global Commercialization of Licensed
Products in the Field in the Territory, and to oversee the implementation of the Global
Commercialization Plans and the Commercialization operational aspects of the Collaboration
on a country-by-country basis. The JCC shall be composed of at least two (2) senior
executives of each Party; provided that the total number of representatives may be changed
upon mutual agreement of the Parties (so long as each Party has an equal number of
representatives).

          (b) JCC Responsibilities. In particular, the JCC shall be responsible for:

          (i) developing and proposing to the JSC the global strategy for the
Commercialization of each Licensed Product in the Field in the Territory;

          (ii) commencing no later than two (2) years prior to the Anticipated First
Commercial Sale anywhere in the Territory, (A) developing (or overseeing the
development of), and updating not less frequently than once per Contract Year, the
Global Commercialization Plan(s) and related Global Commercialization Budget(s) on a
country-by-country basis for final approval by the JSC and (B) establishing, to the
extent provided in Section 3.5, Country/Region Commercialization Committees to
establish Country/Region Commercialization Plans (and related Country/Region
Commercialization Budgets) and any updates thereto and carry out the other
activities described in Section 3.5;

          (iii) **************************************;

29

 

          (iv) Establishing the trade dress for each Licensed Product, consistent with
the guidelines established by the JCC, in the applicable Major Market Country;

          (v) developing forecasts for Commercial Supply Requirements for the Territory
to enable the timely preparation of the Manufacturing Plan(s) for review by the JMC
and approval by the JSC;

          (vi) for each Licensed Product, on a country-by-country basis for the Major
Market Countries, developing and updating, as necessary,
****************************************************;

          (vii) reviewing and overseeing compliance with the Global Commercialization
Plan (including the related Global Commercialization Budget), and Country/Region
Commercialization Plans (including the Country/Region Commercialization Budgets), to
the extent applicable, for each Licensed Product, including ensuring that country
specific launch plans are consistent with the Marketing Guidelines, and reviewing
and validating latest annual estimates for the current calendar year compared to the
Global Commercialization Budget and Country/Region Commercialization Budgets;

          (viii) establishing or validating the number and position of Details required
to meet market and sales forecasts and their conversion into the equivalent number
of Detailing FTEs according to applicable weighting factors, based upon sales force
and market practices, on a country-by-country basis, consistent, however, with the
applicable Marketing Guidelines;

          (ix) for each Licensed Product, selecting a Product Trademark in accordance
with Section 11.2 and giving guidance on trade dress for such Licensed Product;

          (x) determining the launch date for each Licensed Product on a
country-by-country basis in Major Market Countries;

          (xi) *************************;

          (xii) preparing short-term and long-term sales forecasts for each Licensed
Product on a country-by-basis for Major Market Countries and reviewing such
forecasts for the remaining countries;

          (xiii) ************************;

          (xiv) validating the contents, design and layout of packaging for each Licensed
Product in the Field;

          (xv) validating plans and policies regarding journal and other publications
with respect to each Licensed Product in the Field in concert with the JDC;

30

 

          (xvi) formulating a life-cycle management strategy for each Licensed Product in
the Field and evaluating new opportunities for new indications, formulations,
delivery systems and improvements in concert with the JDC;

          (xvii) matters relating to Regeneron’s Commitment Level with respect to a
Licensed Product in a Co-Commercialization Country, including consenting to changes
therein; and

          (xviii) considering and acting upon such other matters as specifically assigned
to the JCC under this Agreement or by the JSC, JDC JFCor JMC.

          3.5 Country/Region Commercialization Committees. The JCC will establish a Country/Region
Commercialization Committee in each Major Market Country, and in each other Reporting
Country/Region as and when determined by the JCC. The Country/Region Commercialization Committees
will be responsible for establishing the Country/Region Commercialization Plans (and related
Country/Region Commercialization Budgets) and any updates thereto with respect to the applicable
Reporting Countries/Region(s). The Country/Region Commercialization Committees will also serve as
a forum to consider and discuss and, if so empowered by the JCC, decide, in a more detailed and
focused manner with respect to the applicable Reporting Countries/Region(s), and make suggestions
or recommendations to the JCC with respect to, the matters referred to in Section 3.4, as
applicable, including the implementation of decisions with respect thereto made by the JCC as
contemplated by such Section 3.4.

          3.6 Joint Finance Committee. The JFC shall be responsible for accounting, financial (including
planning, reporting and controls) and funds flow matters related to the Collaboration and this
Agreement, including such specific responsibilities set forth in Article IX and such other
responsibilities determined by the JSC. The JFC also shall respond to inquiries from the JDC, the
JMC and the JCC, as needed.

          3.7 Joint Manufacturing Committee. Working with the JDC and JCC, as appropriate, the Joint
Manufacturing Committee shall be responsible for overseeing process development and Manufacturing
activities, including preparing and updating the Manufacturing Plan for approval by the JSC and
carrying out such other responsibilities set forth in Article VIII, process and technology
selection, process improvements and related intellectual property filing strategy and obtaining a
common process for manufacturing, recalls, market withdrawals, and any other corrective actions
related to any Licensed Product in the Territory, and for any other matters specifically assigned
to the JMC by the JSC. For process development activities, the Joint Manufacturing Committee shall
consult the appropriate expert functions within both Parties or their Affiliates as appropriate.

          3.8 Membership.
Each of the Committees shall be composed of an equal number of representatives appointed by each
of Regeneron and Sanofi. Each Party may replace its Committee members upon written notice to the
other Party. Each Committee will have two (2) co-chairpersons, one designated by each of Regeneron
and Sanofi. Each co-chairperson shall be

31

 

entitled to call meetings. The co-chairpersons shall
coordinate activities to prepare and circulate an agenda in advance of the meeting and prepare and
issue final minutes within thirty (30) days thereafter.

          3.9 Meetings. Each Committee shall hold meetings at such times as the Parties shall determine,
but in no event less frequently than once every Quarter during the Term, commencing from and after
the time such Committee is established as provided herein. If possible, the meetings shall be held
in person (to the extent practicable, alternating the site for such meetings between the Parties or
their Affiliates) or when agreed by the Parties, by video or telephone conference. Other
representatives of each Party or of Third Parties involved in the Development, Manufacture or
Commercialization of any Licensed Product in the Field (under obligations of confidentiality) may
be invited by the Committee co-chairs to attend meetings of the Committees as nonvoting
participants. Each Party shall be responsible for all of its own expenses of participating in the
Committees. Either Party’s representatives on a Committee may call a special meeting of the
applicable Committee upon at least five (5) Business Days’ prior written notice, except that
emergency meetings may be called with at least two (2) Business Days’ prior written notice.

          3.10 Decision-Making. The Committees shall operate by consensus. The representatives of each
Party shall have collectively one (1) vote on behalf of such Party; provided that no such vote
taken at a meeting shall be valid unless a representative of each Party is present and
participating in the vote. Notwithstanding the foregoing, each Party, in its sole discretion, by
written notice to the other Party, may choose not to have representatives on a Committee and leave
decisions of such Committee(s) to representatives of the other Party.

          3.11 Resolution of Governance Matters. As provided in Section 10.2, this Section 3.11 shall
apply to matters constituting, or which if not resolved would constitute, a Governance Dispute.

          (a) Generally. The Parties shall cause their respective representatives on the
Committees to use their Commercially Reasonable Efforts to resolve all matters presented to
them as expeditiously as possible, provided that, in the case of any matter which cannot be
resolved by the JDC, JCC, CRCC, JMC, JFC or other relevant Committee established hereunder,
at the request of either Party, such matter shall promptly, and in any event within ten (10)
Business Days (or two (2) Business Day in the event of an urgent matter) after such request,
be referred to the JSC with a request for resolution.

          (b) Referral to Executive Officers. In the event that the JSC is, after a
period of five (5) Business Days from the date a matter is submitted to it for resolution
pursuant to Section 3.11(a), unable to make a decision due to a lack of required unanimity,
then either Party may require that the matter be submitted to the Executive Officers for a
joint decision. In such event, either Party may, in a written notice to the other Party,
formally request that the dispute be resolved by the Executive Officers, specifying the
nature of the dispute with sufficient specificity to permit adequate consideration by such
Executive Officers. The Executive Officers shall diligently and in

32

 

good faith, attempt to
resolve the referred dispute within five (5) Business Days of receiving such written
notification, failing which, ***********************.

          (c) Notwithstanding the foregoing, and subject to Section 10.4, Legal Disputes and
disputes referred to in the third sentence of Section 2.6(b) which involve a Technical
Development Matter shall be referred to the Executive Officers with no Party’s Executive
Officer having final decision making authority.

          (d) Interim Budgets. Pending resolution by the Executive Officers of any
referred dispute under Section 3.11(b) and subject to the terms of Section 19.2, the
Executive Officers shall negotiate in good faith in an effort to agree to appropriate
interim budgets and plans to allow the Parties to continue to use Commercially Reasonable
Efforts to Develop, Manufacture and Commercialize the Licensed Products in the Field in the
Territory pursuant to this Agreement. The most recent Committee approved Plan(s) shall be
extended pending approval by the Executive Officers of the interim budget(s) and Plan(s)
referred to in this Section 3.11(c).

          (e) Obligations of the Parties. The Parties shall cause their respective
designees on the Committees and their respective Executive Officers to take the actions and
make the decisions provided herein to be taken and made by such respective designees and
Executive Officers in the manner and within the applicable time periods provided herein. To
the extent a Party performs any of its obligations hereunder through any Affiliate of such
Party, such Party shall be fully responsible and liable hereunder and thereunder for any
failure of such performance, and each Party agrees that it will cause each of its Affiliates
to comply with any provision of this Agreement which restricts or prohibits a Party from
taking any specified action.

ARTICLE IV

LICENSE GRANTS

          4.1 Regeneron License Grants. Subject to the terms and conditions of this Agreement
(including, without limitation, Section 4.6) and any License to which Regeneron is a party,
Regeneron hereby grants to Sanofi (a) the nontransferable (except as permitted by Section 20.9),
co-exclusive (with Regeneron and its Affiliates) right and license under the Regeneron Intellectual
Property to make, have made, use, develop and import Licensed Products for use in the Field in the
Territory, and (b) the nontransferable (except as permitted by Section 20.9), exclusive (except as
otherwise provided
below in this Section 4.1) right and license under the Regeneron Intellectual Property to sell and
offer to sell Licensed Products in the Field in the Territory, except that the right and license
granted pursuant to this clause (b) shall be co-exclusive (with Regeneron and its Affiliates) to
the extent of Regeneron’s right to Co-Promote Licensed Products and Regeneron’s right to supply
Licensed Products to Sanofi, as contemplated by this Agreement. Sanofi will have the right to
grant sublicenses under the foregoing license only as set forth in Section 4.4.

          4.2 Sanofi License Grants. Subject to the terms and conditions of this Agreement and any
License to which Sanofi or any of its Affiliates is a party, Sanofi hereby grants to Regeneron the
nontransferable (except as permitted by Section 20.9), royalty-free, co-

33

 

exclusive (with Sanofi and
its Affiliates) right and license under the Sanofi Intellectual Property to the extent necessary to
make, have made, use, develop and import Licensed Products for use in the Field in the Territory
and to Co-Promote Licensed Products to the extent provided in this Agreement.

          4.3 Newly Created Intellectual Property. In addition to the other licenses granted under this
Article IV and subject to the other terms and conditions of this Agreement, to the extent permitted
under any relevant Third Party agreement, each Party grants to the other Party and its Affiliates
the perpetual, royalty-free, paid-up, non-exclusive, worldwide right and license, with the right to
grant sublicenses, to use and practice for any and all purposes: all intellectual property
(including, without limitation, Know-How, Patents and Patent Applications and copyrights), other
than Know-How jointly owned pursuant to Section 12.1(e) and other than Excluded Rights, discovered,
invented, authored or otherwise created by it (or its Affiliate) after the Effective Date directly
in connection with the performance of the research and clinical activities approved by the JDC, in
each case, as included in the Global Development Plans. As used above, the term “Excluded
Rights” shall mean any Patents or Know-How claiming or covering composition (including any
formulation) of a Licensed Product. For the avoidance of doubt, nothing in this Section 4.3 shall
be construed to grant either Party any license to Patents or Know-How of the other Party
discovered, invented, authored or otherwise created by it outside the performance of the research
activities approved by the JDC and/or the clinical development activities approved by the JDC, in
each case, as included in Global Development Plans.

          4.4 Sublicensing. Unless otherwise restricted by any License, Sanofi will have the right to
sublicense any of its rights under the first sentence of Section 4.1 only with the prior written
consent of Regeneron, such consent not to be unreasonably withheld or delayed with respect to
rights outside the Major Market Countries (and only with the prior written consent of Regeneron,
which consent may be withheld for any reason, in the Major Market Countries), except that Sanofi
may sublicense any of its rights hereunder to an Affiliate for purposes of meeting its obligations
under this Agreement without Regeneron’s consent. Unless otherwise restricted by any License,
Regeneron will have the right to sublicense any of its rights under Section 4.2 with the prior
written consent of Sanofi, such consent not to be unreasonably withheld or delayed, except that
Regeneron may
sublicense any of its rights hereunder to an Affiliate for purposes of meeting its obligations
under this Agreement without Sanofi’s consent. Each Party shall remain responsible and liable for
the compliance by its Affiliates and Sublicensees with applicable terms and conditions set forth in
this Agreement. Any such sublicense agreement will require the Sublicensee of a Party to comply
with the obligations of such Party as contained herein, including, without limitation, the
confidentiality and non-use obligations set forth in Article XVI, and will include, with respect to
a Sublicensee of Sanofi, an obligation of the Sublicensee to account for and report its sales of
Licensed Products to Sanofi on the same basis as if such sales were Net Sales by Sanofi. For the
avoidance of doubt, Regeneron shall be entitled to receive its share of the applicable Profit Split
based on Net Sales of Licensed Products sold by Sublicensees under this Agreement. In the event of
a breach by a Sublicensee of any sublicense agreement which has or is reasonably likely to have an
adverse effect on either Party or any of its Affiliates or any Party’s Intellectual Property, then
the harmed Party may cause the other Party or its Affiliate to exercise, and the other Party or its
Affiliate will promptly exercise, any termination rights it may have under the sublicense with the
Sublicensee. Any

34

 

sublicense agreement will provide for the termination of the sublicense or the
conversion of the sublicense to a license directly between the Sublicensee and the other Party, at
the option of the other Party, upon termination of this Agreement. Furthermore, any such
sublicense shall prohibit any further sublicense or assignment. Each Party will forward to the
other Party a complete copy of each applicable fully executed sublicense agreement (and any
amendment(s) thereto) within ten (10) days of the execution of such agreement.

          4.5 No Implied License. Except as expressly provided in this Article IV or elsewhere in this
Agreement, neither Party will be deemed by this Agreement to have been granted any license or other
rights to the other Party’s Patent Rights, Know-How, or Party Information either expressly or by
implication, estoppel or otherwise.

          4.6 Retained Rights. With respect to the licenses granted under this Article IV, and for the
avoidance of doubt, Regeneron expressly reserves for itself and its Affiliates and Third Party
licensees under the Regeneron Intellectual Property and Regeneron’s interest in the Joint
Inventions, the right to Manufacture and to Commercialize Licensed Products for use in the Field in
the Territory in accordance with this Agreement. For the further avoidance of doubt, Regeneron
retains all rights in Regeneron Intellectual Property, Regeneron’s interest in the Joint Inventions
and Licensed Products not expressly licensed hereunder, including, without limitation the right to
exploit Regeneron Intellectual Property and Regeneron’s interest in Joint Inventions for purposes
unrelated to the Licensed Products in the Field. With respect to the licenses granted under this
Article IV, and for the avoidance of doubt, Sanofi expressly reserves for itself and its Affiliates
and Third Party licensees under the Sanofi Intellectual Property and Sanofi’s interest in the Joint
Inventions, the right to Manufacture and to Commercialize Licensed Products for use in the Field in
the Territory in accordance with this Agreement. For the avoidance of doubt, Sanofi retains all
rights in Sanofi Intellectual Property, Sanofi’s interest in the Joint Inventions and Licensed
Products not expressly licensed hereunder, including, without limitation, the right to exploit
Sanofi Intellectual Property and Sanofi’s interest in Joint Inventions for purposes unrelated to
the Licensed Products in the Field.

ARTICLE V

DEVELOPMENT ACTIVITIES

5.1 Development of Licensed Products. Subject to the terms of this Agreement, the Parties
shall undertake Development activities with respect to Licensed Products in the Field pursuant to
the Global Development Plans under the general direction and oversight of the JDC. Each Party
shall use Commercially Reasonable Efforts to Develop Licensed Products in the Field, carry out the
Development activities assigned to it in Development Plans in a timely manner and conduct all such
activities in compliance with applicable Laws, including, without limitation, Good Practices.

5.2 Global Development Plans. With respect to each Licensed Product, the JDC shall prepare and
present a Global Development Plan for approval by the JSC, and the JSC shall approve a Global
Development Plan for such Licensed Product, within three (3) months after the time such Licensed
Product first becomes a Licensed Product in accordance with the terms of the Discovery Agreement
and this Agreement, and shall, subject to the further provisions of this Section 5.2, determine
which Party will take the lead in the Development of

35

 

such Licensed Product. Prior to such JSC
approval of the first Global Development Plan for any Licensed Product, the Parties shall Develop
the Licensed Product in accordance with the applicable Initial Development Plan, including, in the
case of REGN88 (IL-6RmAb), a summary outline of an Initial Development Plan attached hereto as
Exhibit B. An updated Global Development Plan for such Licensed Product will be presented by the
JDC for approval by the JSC, and approved by the JSC, at least two (2) months prior to the end of
each Contract Year. Each Global Development Plan for a Licensed Product will set forth the plan
for Development of such Licensed Product in the Field over at least three (3) Contract Years and
will include (a) strategies and timelines for Developing and obtaining Approvals for such Licensed
Product in the Field in the Territory, and (b) the allocation of responsibilities for Development
activities between the Parties, and/or Third Party service providers. Each Global Development Plan
will be reviewed and informally updated by the JDC not less frequently than once every six (6)
months for the ensuing three (3) year period. Unless and to the extent otherwise agreed by the
Parties with respect to a particular Licensed Product, (i) the Parties shall alternate, on a
Licensed Product-by-Licensed Product basis, in being allocated principal responsibility for
formulating, and carrying out, the principal Development activities for the applicable Licensed
Product under the applicable Global Development Plan(s) from the time the applicable Product
Candidate is advanced into Development in accordance with the Discovery Agreement (whereupon such
Product Candidate automatically constitutes a Licensed Product) through proof of concept as defined
in the Global Development Plan for the Licensed Product (the “POC Time”) (with respect to
any Licensed Product, the Party with such principal responsibility through the POC Time being
referred to as the “POC Principal Party”) and (ii) the Parties shall alternate being
allocated principal responsibility for formulating, and carrying out, all clinical trials conducted
subsequent to the POC Time for the applicable
Licensed Product(s) under the applicable Global Development Plan(s) (with respect to a Licensed
Product, the Party with such principal responsibility being referred to as the “Post-POC
Principal Party”), with Sanofi being the Post-POC Principal Party for two (2), and Regeneron
being the Post-POC Principal Party for one (1), out of each three (3) Licensed Products. The
Parties shall cause their respective representatives on the JDC and the JSC, in preparing, updating
and approving Global Development Plans, to allocate principal Development responsibilities
thereunder as provided in this Section 5.2.

          5.3 Global Development Budgets. Each Global Development Plan for a Licensed Product shall
include a related Global Development Budget (each individually, a “Global Development
Budget” and collectively, “Global Development Budgets”) and each Global Development
Budget shall be prepared, updated, reviewed and approved as part of the preparation, update and
approval of the Global Development Plan of which such Global Development Budget is a part in
accordance with this Agreement. Amendments and updates to any Global Development Budget shall not
be effective without the approval of the JSC.

          5.4 Development Reports. Within forty-five (45) days after the end of each Quarter, commencing
in the first Quarter in which Development activities commence hereunder with respect to the first
Licensed Product, Regeneron and Sanofi shall each provide to the other Party a written report (in
electronic form) summarizing the material activities undertaken by such Party during such Quarter
in connection with each Global Development Plan, together with a statement of Development Costs
incurred by such Party during such Quarter, which statement shall detail those amounts to be
included in the Consolidated Payment Report for such Quarter

36

 

and shall be in such form, format and
of such level of detail as approved by the JFC. At the next JSC meeting held following such
forty-five (45) day period, the JSC will approve the final Development Costs which will be used in
calculating the Global Development Balance.

          5.5 Review of Clinical Trial Protocols. The JDC will establish procedures for the expeditious
review of clinical trial protocols for the Licensed Products submitted to the JDC by Regeneron
pursuant to Section 2.6(b), including, without limitation, pre-approval authorizations for
Non-Approval Trials.

          5.6 Regeneron Early Development Opt-Out. Within thirty (30) days of the date that Sanofi
exercises its Opt-In Rights with respect to any Licensed Product thereby including such Licensed
Product under this Agreement, Regeneron shall have a one-time right to opt-out of the further
Development of such Licensed Product (such right of Regeneron, the “Regeneron Early Development
Opt-Out Right”, and each such Licensed Product as to which Regeneron has exercised the
Regeneron Early Development Opt-Out Right, an “Early Development Opt-Out Product”) by
delivering written notice of such opt-out (a “Regeneron Early Opt-Out Notice”) to Sanofi.
Effective immediately upon the delivery by
Regeneron to Sanofi of a Regeneron Early Opt-Out Notice with respect to a Licensed Product, (i)
such Licensed Product shall automatically constitute an Early Development Opt-Out Product, (ii) the
rights and licenses granted by Regeneron to Sanofi hereunder with respect to such Early Development
Opt-Out Product shall automatically terminate, (iii) Sanofi and its Affiliates shall have a
worldwide, fully paid-up, royalty-free (other than for amounts payable to Third Parties for any
intellectual property or technology contributed to the Discovery Program or the Collaboration by
Regeneron), exclusive right and license, with the right to sublicense unless otherwise restricted
by any License, under the Regeneron Intellectual Property existing at the time the Regeneron Early
Opt-Out Notice was delivered to Sanofi, to Develop, Manufacture and Commercialize in the Field in
the Territory (and solely to the extent that such Regeneron Intellectual Property has, as of the
date of the Regeneron Early Opt-Out Notice, actually been incorporated into such Early Development
Opt-Out Product or otherwise claims or covers its use) the Early Development Opt-Out Product with
respect to which such Regeneron Early Development Opt-Out Notice was delivered, (iv)
*****************************, (v) Regeneron shall, as promptly as reasonably practicable, transfer
to Sanofi all clinical activities related to the Early Development Opt-Out Product, (vi) except as
set forth in this Section 5.6, Regeneron shall have no further rights or obligations with respect
to such Early Development Opt-Out Product, (vii) Sanofi shall be free to Develop and Commercialize
such Early Development Opt-Out Product in the Field in the Territory free of any obligations to
Regeneron hereunder, except for reimbursing Regeneron for any pass through costs to Third Party
licensors of Regeneron Intellectual Property, to the extent attributable to the Development or
Commercialization of Licensed Products by Sanofi, and (viii) *************************. As used in
clause (viii) immediately above, “antibody” shall mean any actual or potential therapeutic or
diagnostic antibody (whether fully human, humanized, phage display, chimeric, polyclonal, or any
other type of antibody), or any derivative, or fragment thereof, including any immunoconjugates or
fusions comprising any such gene product, derivative or fragment, and any composition or
formulation that incorporates or includes any of the foregoing. Except as provided in this Section
5.6, a Party’s obligations under this Agreement with respect to the Development of a Licensed
Product shall terminate only upon termination of this Agreement

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with respect to such Licensed
Product or in its entirety in accordance with, and only to the extent and upon the terms and
conditions set forth in, Article XIX.

ARTICLE VI

COMMERCIALIZATION

          6.1 Commercialization of Licensed Products in the Field in the Territory. Subject to the terms
of this Agreement, the Parties shall undertake Commercialization activities with respect to
Licensed Products in the Field in the Territory under the direction and oversight of the JCC.
Sanofi shall be the lead Party with respect to the Commercialization of Licensed Products in the
Field. Sanofi shall use Commercially Reasonable Efforts to Commercialize Licensed Products in the
Field, and carry out the Commercialization activities in accordance with the applicable Global
Commercialization Plan and the applicable Country/Region Commercialization Plans in a timely manner
and conduct all such activities in compliance with applicable Laws. Except as otherwise provided
in this Agreement, Sanofi shall bear all costs and expenses to Commercialize the Licensed Products
in the Field in the Territory. Sanofi or its
Affiliate shall invoice and book all sales of the Licensed Products in the Field in the Territory
and shall appropriately record all such sales. Sanofi or its Affiliate shall also be responsible
for the distribution of the Licensed Products in the Field in the Territory and for paying all
governmental rebates which are due or owing with respect to the Licensed Products in the Field in
the Territory. Commencing with the initiation of Phase 3 Trials for a Licensed Product in

the Field in the Territory, the Parties will commence regular ad hoc discussions concerning the
Commercialization strategy for the Licensed Product.

          6.2 Global Commercialization Plan(s). Each Global Commercialization Plan and all updates and
amendments thereto will be consistent with the principles of the Collaboration Purpose. Each
Global Commercialization Plan shall be prepared by Sanofi (with assistance from Regeneron) at the
direction of the JCC, and submitted to the JCC for review and approval. Once approved by the JCC,
a Global Commercialization Plan will be presented to the JSC for review and approval at least
***********************. Such Global Commercialization Plan for each subsequent Contract Year
shall be updated by the JCC and approved by the JSC at least one (1) month prior to the end of the
then current Contract Year. The Global Commercialization Plan with respect to each Licensed
Product shall include (with sufficient detail, relative to time remaining to Anticipated First
Commercial Sale, to enable the JCC and JSC to conduct a meaningful review of such Plan) information
and formatting as will be agreed upon by the JCC, including:

          (a) the overall global strategy for Commercializing such Licensed Product in the Field
in the Territory, including target product profiles, branding, positioning, promotional
materials and core messages for such Licensed Product;

          (b) *******************************************;

          (c) the related Global Commercialization Budget;

          (d) anticipated launch dates for such Licensed Product for Major Market Countries;

38

 

          (e) market and sales forecasts for such Licensed Product in the Field in the Territory
in a form to be agreed between the Parties;

          (f) strategies for the detailing and promotion of such Licensed Product in the Field in
the Territory;

          (g) anticipated major advertising, public relations and patient advocacy programs for
such Licensed Product in the Field in the Territory;

          (h) Non-Approval Trials; and

          (i) all other Marketing Guidelines.

          6.3 Country/Region Commercialization Plans.
Each Country/Region Commercialization Plan and all updates and amendments
thereto will be consistent with the principles of the Collaboration Purpose. It is
anticipated that each Country/Region Commercialization Plan for each Licensed Product will
be prepared by Sanofi (with assistance from Regeneron in the U.S. and all
Co-Commercialization Countries), and approved by the JCC, at least *****************. Such
Country/Region Commercialization Plan for each subsequent Contract Year shall be updated by
the applicable Country/Region Commercialization Committee, and approved by the JCC, at least
two (2) months prior to the end of the then current Contract Year. Each Country/Region
Commercialization Plan with respect to each Licensed Product shall include (with sufficient
detail, relative to time remaining to Anticipated First Commercial Sale, to enable the JCC
to conduct a meaningful review of such Plan) information and formatting as will be agreed
upon by the JCC, including the overall strategy for Commercializing such Licensed Product,
***********, market and sales forecasts, and estimated FTE and Shared Commercial Expenses.
In those countries where the Parties are Co-Promoting a Licensed Product, such
Country/Region Commercialization Plans shall include more detailed information on the
coordination of detailing and promotional efforts, including the estimated number of
detailing FTEs for each Party (based on the number and position of Details required to meet
the market and sales forecasts) and the specific allocation of Co-Promotion efforts between
the Parties.

          6.4 Commercialization Efforts; Sharing of Commercial Information.

          (a) Sanofi (through its Affiliates where appropriate) shall use Commercially Reasonable
Efforts to Commercialize Licensed Products in the Field in the Territory in accordance with
the Global Commercialization Plans, the Marketing Guidelines and, as applicable, the
Country/Region Commercialization Plan(s). Without limiting the generality of the foregoing,
(i) Sanofi will, as necessary, build, train and apply a field force necessary to
Commercialize the Licensed Products in the Field in accordance with the applicable Global
Commercialization Plans and Country/Region

39

 

Commercialization Plans, (ii) Sanofi’s, and in
the Co-Commercialization Countries each Party’s, sales representatives shall provide the FTE
effort and detail the Licensed Products in the Field in accordance with the approved
Country/Region Commercialization Plan (if applicable), Global Commercialization Plan(s) and
all applicable Laws.

          (b) Sanofi will provide Regeneron with full access to material information directly
relating to the Commercialization of each Licensed Product in the Field, including, without
limitation, information relating to anticipated launch dates, key market metrics, market
research, and sales. Without limiting the foregoing, beginning in the Quarter of the First
Commercial Sale in each Major Market Country, Sanofi will provide Regeneron, and with
respect to each Co-Commercialization Country, Regeneron will provide Sanofi, on a quarterly
basis, with reports of the activity within its field force
in each such Major Market Country, which will include reasonable data from reports
created by Sanofi or Regeneron for its internal management purposes.

          (c) Each Party shall, on a periodic and reasonably current basis, keep the other Party
informed regarding major market developments, acceptance of the Licensed Products in the
Field, Licensed Product quality complaints and similar information.

          (d) No Party may initiate or support any Non-Approval Trial for a Licensed Product in
the Field in the Territory without the prior approval of the JDC.

          6.5 Co-Commercialization of Licensed Products.

          (a) Exercise of Co-Promote Option by Regeneron. In the event that Regeneron
desires to Co-Promote a Licensed Product in a particular country, Regeneron shall notify
Sanofi of (i) its preliminary indication of intent regarding such Co-Promotion of such
Licensed Product at least ************************* and (ii) its final decision regarding
whether to Co-Promote such Licensed Product in such country at
******************************. If Regeneron does not timely notify Sanofi of its
preliminary indication or of its final decision within the periods set forth in clause (i)
or (ii) above, as applicable, Regeneron shall not be entitled to exercise its option to
Co-Promote such Licensed Product in such country until on or after the
**************************************.

          (b) Co-Commercialization. Sanofi and Regeneron (through their respective
Affiliates where appropriate) shall Co-Commercialize Licensed Products under the applicable
Product Trademarks in each Co-Commercialization Country in accordance with the then-current
and applicable Country/Region Commercialization Plan. Each Party shall use, or shall cause
its local Affiliates to use, Commercially Reasonable Efforts to Co-Commercialize the
Licensed Products in the Co-Commercialization Countries, and carry out the activities
assigned to it in the applicable Country/Region Commercialization Plan. Each Party shall
ensure that its Co-Commercialization activities conform with the parameters in the
applicable approved Country/Region Commercialization Plan and the applicable Global
Commercialization Plan.

          (c) Decision to Discontinue Co-Commercialization. In the event that Regeneron
decides it no longer wishes to Co-Commercialize a Licensed Product in a

40

 

particular
Co-Commercialization Country or does not wish to maintain its minimum sales force FTE
requirement for Co-Commercialization of such Licensed Product in such Co-Commercialization
Country, provided that Regeneron has Co-Commercialized Licensed Product and maintained its
minimum sales force FTE requirement for ************** in such Co-Commercialization Country
from the date it commences Co-Promoting in such Co-Commercialization Country, Regeneron must
give the JCC and Sanofi ********** prior written notice of such decision. At the end of
such ********* period, Regeneron shall cease all Co-Commercialization activities with
respect to such Licensed Product in such Co-Commercialization Country.
**************************.

          (d) Field Force Coordination. The JCC or the applicable Committee shall
coordinate the Co-Promotion of each Licensed Product by Sanofi, Regeneron, their respective
local Affiliates and their respective sales representatives in each Co-Commercialization
Country. The Parties will cooperate in the conduct of such activities with respect to
scheduling, geographical allocation, and Professional or other customer targeting in order
to optimize profits under the applicable Country/Region Commercialization Plan. Without
limiting the generality of the foregoing, in each Co-Commercialization Country the Parties
will share and, to the extent appropriate, cooperate to implement consistent policies and
procedures with respect to the manner in which details and other sales visits are conducted.

          (e) Co-Commercialization FTE Efforts.

          (i) FTE Efforts. Upon the exercise of its election pursuant to Section
6.5(a) to Co-Promote in a country, Regeneron will provide to Sanofi a binding notice
of the FTE effort that Regeneron commits to deliver in Co-Promoting such Licensed
Product in such country during the first (1st) Contract Year for which Regeneron
exercised its right to Co-Promote (the “Regeneron Commitment Level”).
Subject to the provisions of Section 6.4(e)(ii), if Regeneron elects to Co-Promote a
Licensed Product in a country, in no event shall the Regeneron Commitment Level be
less than ****************** of the total anticipated FTE effort by both Parties
(taken together) in Co-Promoting such Licensed Product in such Co-Commercialization
Country, unless otherwise agreed by the Parties. Such FTE effort shall be based
upon the forecasted number and position of Details required to meet the market and
sales forecasts in such Co-Commercialization Country, and their conversion (by the
JCC or applicable Country/Region Commercialization Committee) into the equivalent
number of
Detailing FTEs according to applicable weighting factors, based upon the sales
force and marketing practices in such Co-Commercialization Country. In no event
shall the Regeneron Commitment Level in Co-Promoting such Licensed Product in such
Co-Commercialization Country exceed ************ of the anticipated total FTE effort
by both Parties in Co-Promoting such Licensed Product in such Co-Commercialization
Country or such other maximum percentage agreed by the Parties (the “Maximum
Regeneron Effort”). Regeneron’s binding notice referred to above in this
Section 4(e)(i) shall be accompanied by a plan (which shall be developed by
Regeneron in cooperation

41

 

with Sanofi and shall be intended to coordinate and
integrate the Parties’ respective FTE efforts and detailing activities) for ensuring
that Regeneron will have in place a field force of qualified sales representatives
to satisfy the Regeneron Commitment Level. In each Co-Commercialization Country,
Sanofi shall perform the anticipated total FTE effort above the Regeneron Commitment
Level.

          (ii) Ophthalmology. In the event that a Licensed Product receives
Marketing Approval for an Indication related to ophthalmology, then, at Regeneron’s
option, Regeneron shall have the lead in the promotion of such Licensed Product in
such Indication, provided, however, that the limitations set forth in Section
6.5(e)(i) shall apply.

          (f) Training. The Parties will coordinate sales force training efforts in
Co-Commercialization Countries and will share training materials (and conduct joint
training, where appropriate) to facilitate joint sales force training efforts.

          (g) Samples. Sanofi shall provide Regeneron with Licensed Product samples for
use in Co-Commercialization Countries as required in the applicable Country/Region
Commercialization Plan. Sanofi and Regeneron (and their respective Affiliates) shall use
samples strictly in accordance with the then-applicable approved Country/Region
Commercialization Plan and shall store and distribute samples in compliance with applicable
Laws. Each Party (and its local Affiliates) will maintain those records required by all
applicable Laws and shall allow representatives of the other Party to inspect such records
and storage facilities for the Licensed Product samples on request.

          6.6 Licensed Product Pricing and Pricing Approvals in the Territory.
**********************.

          6.7 Sales and Licensed Product Distribution in the Territory; Other Responsibilities.

          (a) Sanofi (or its Affiliate) shall invoice and book, and appropriately record, all
sales of the Licensed Products in the Field in the Territory. Sanofi (or its Affiliate)
also shall be responsible for (i) the distribution of Licensed Products in the Field in the
Territory and for paying all governmental rebates which are due and owing with respect to
the Licensed Products in the Field in the Territory, (ii) handling all returns
of Licensed Product sold under this Agreement and (iii) handling all aspects of
ordering, processing, invoicing, collection, distribution and receivables with respect to
Licensed Products in the Field in the Territory.

          (b) Sanofi (through its local Affiliates where appropriate), and with respect to the
Co-Commercialization Countries, Regeneron (through its local Affiliates where appropriate),
shall maintain records relating to its sales representative FTEs for the Licensed Products
in the Field in the countries in a manner sufficient to permit the

42

 

determination of Sales
Force Cost and Medical Post-Approval Cost and the incentive compensation requirements set
forth in the Marketing Guidelines.

          6.8 Contract Sales Force. Each Party shall be entitled to engage a Contract Sales Force
for up to ********* of such Party’s Sales Force utilized for any Licensed Product to discharge its
annual FTE effort with respect to Commercialization of such Licensed Product, provided that in the
event that Regeneron discontinues Co-Commercialization in a particular Co-Commercialization
pursuant to Section 6.5(c), then Sanofi shall be entitled to engage a Contract Sales Force for more
than ************** for that Co-Commercialization Country. If a Party (or its local Affiliate)
retains a Contract Sales Force, that Party (or its local Affiliate) will be responsible for (i) all
costs associated with retaining such Contract Sales Force above approved Sales Force Costs included
in the applicable Country/Region Commercialization Budget and for the Contract Sales Force’s
compliance with this Agreement, including, without limitation, the training and monitoring of such
Contract Sales Force and ensuring compliance with all applicable Laws, and (ii) ensuring that sales
representatives in such Contract Sales Force have minimum skill levels customary for sales
representatives in major pharmaceutical companies in such country in the relevant therapeutic area.

          6.9 Promotional Materials.

          (a) Except as provided in and subject to Section 6.9(b): Sanofi will be responsible,
consistent with the Marketing Guidelines, the Global Commercialization Plan and the
Country/Region Commercialization Plans (as applicable) and the decisions of the JCC with
respect to Promotional Materials as contemplated by Section 3.4(b)(vi), for the creation,
preparation, production and reproduction of all Promotional Materials and for filing, as
appropriate, all Promotional Materials with all Regulatory Authorities in the Territory,
except where Regeneron shall perform such responsibilities as the Lead Regulatory Party.
Upon request, Regeneron will have the right to review and comment on all major Promotional
Materials for use in any country in the Territory prior to their distribution by Sanofi for
use in the Territory.

          (b) The Parties and their Affiliates shall only use the Promotional Materials and only
conduct marketing and promotional activities for the Licensed Products which, in each case,
are approved by the JCC or the applicable Country/Region Commercialization Committee if so
delegated by the JCC for the applicable Major Market Country. Sanofi shall ensure that
Regeneron’s sales representatives are provided with reasonable quantities of Promotional
Materials for use in a Co-Commercialization Country consistent with the Regeneron Commitment
Level for such Co-Commercialization Country in accordance with the applicable approved
Country/Region
Commercialization Plan. All Promotional Materials generated for a Co-Commercialization
Country shall be maintained in confidence and shall not be disclosed or distributed to Third
Parties, until such time as they have been reviewed and approved as set forth in this
Section.

          (c) Sanofi shall own all rights to all Promotional Materials, including all copyrights
thereto, in the Major Market Countries.

43

 

          6.10 Promotional Claims/Compliance. Neither Party nor any of its Affiliates shall make any
medical or promotional claims for any Licensed Product in the Field other than as permitted by
applicable Laws. When distributing information related to any Licensed Product or its use in the
Field in the Territory (including information contained in scientific articles, reference
publications and publicly available healthcare economic information), each Party and its Affiliates
shall comply with all applicable Laws and any guidelines established by the pharmaceutical industry
in the applicable country.

          6.11 Restriction on Bundling in the Territory. If Sanofi or its Affiliates or Sublicensees
sell a Licensed Product in the Field in the Territory to a customer who also purchases other
products or services from any such entity, Sanofi agrees not to, and to require its Affiliates and
Sublicensees not to, bundle or include any Licensed Product as part of any multiple product
offering or discount or price the Licensed Products in a manner that (a) is reasonably likely to
disadvantage a Licensed Product in order to benefit sales or prices of other products offered for
sale by a Party or its Affiliates to such customer, (b) is inconsistent with the Collaboration
Purpose or (c) would result in pricing and discounting inconsistent with the applicable Marketing
Guidelines.

          6.12 Inventory Management. Sanofi shall use Commercially Reasonable Efforts to manage
Licensed Product inventory on hand at wholesalers and Sublicensees so as to maintain levels of
inventory appropriate for expected demand and to avoid taking action that would result in unusual
levels of inventory fluctuation.

          6.13 Medical and Consumer Inquiries. The JCC shall establish guidelines to handle medical
questions or inquiries from consumers relative to Licensed Products.

          6.14 Market Exclusivity Extensions. Each Party shall use Commercially Reasonable Efforts
to maintain, and, to the extent available, legally extend, the period of time during which, in any
country in the Territory, (a) a Party(ies) has the exclusive legal right, whether by means of a
Patent Right or through other rights granted by a Governmental Authority in such country, to
Commercialize a Licensed Product in the Field in such country and (b) no generic equivalent of a
Licensed Product in the Field may be marketed in such country.

          6.15 Post Marketing Clinical Trials. Subject to the provision of this Agreement, the
Parties shall comply with any clinical trials obligations with respect to a Marketing Approval with
respect to any Licensed Product use in the Field in any country in the Territory, imposed by
applicable Law, pursuant to the Approvals or required by a Regulatory Authority.

ARTICLE VII

CLINICAL AND REGULATORY AFFAIRS

          7.1 Ownership of Approvals and Registration Filings.

          (a) Unless otherwise agreed to by the Parties, the Post-POC Principal Party shall be
the Lead Regulatory Party and shall own (i) all Approvals with respect to Licensed Product
in the Territory and (ii) the IND for Licensed Products during such time

44

 

as it is the
Post-POC Principal Party and shall have the rights and obligations set forth in Sections 7.2
to 7.4 (inclusive) with respect thereto. ******************************.

          (b) The Lead Regulatory Party shall license, transfer, provide a letter of reference
with respect to, or take other action necessary to make available the relevant Registration
Filings and Approvals to and for the benefit of the other Party.

          (c) The non-Lead Regulatory Party shall provide such assistance with respect to
regulatory matters as is reasonably requested by the Lead Regulatory Party and consistent
with the terms of this Agreement.

     7.2 Regulatory Coordination.

          (a) The Lead Regulatory Party shall oversee, monitor and coordinate applicable
regulatory actions, communications and filings with and submissions (including supplements
and amendments thereto) to each applicable Regulatory Authority with respect to each
Licensed Product in the Field in each jurisdiction as to which it is the Lead Regulatory
Party; provided that it shall adhere to the obligations in this Article VII. Without
limiting the foregoing, the Lead Regulatory Party will be responsible for, and will use
Commercially Reasonable Efforts in applying for, obtaining and maintaining the applicable
Approval or other Registration Filing for each Licensed Product in the Field for which it
has responsibility as the Lead Regulatory Party. To the extent applicable, the Lead
Regulatory Party shall perform all such activities in accordance with the Plans and all
applicable Laws.

          (b) The Parties shall establish procedures, through the JDC or the JCC, to ensure that
the Parties exchange on a timely basis all necessary information to enable the other Party
and its licensees, as applicable, (i) to comply with its regulatory obligations in
connection with the Development, Manufacture and/or Commercialization of the Licensed
Products in the Field, including, without limitation, filing updates or supplements with
Regulatory Authorities, pharmacovigilance filings, manufacturing supplements and
investigator notifications to Regulatory Authorities and (ii) to comply with Laws in
connection with the Development, Manufacture and/or Commercialization of the Licensed
Products in the Field anywhere in the Territory. The Parties shall provide to each other
prompt written notice of any Approval of a Licensed Product in the Field anywhere in the
world. The Parties shall work together cooperatively through the JDC in the preparation of
regulatory strategies and with respect to all material regulatory actions, communications
and Regulatory Filings for Licensed Products in the Field in the Territory.

          (c) The Lead Regulatory Party shall use Commercially Reasonable Efforts to provide the
other Party as promptly as practicable with written notice and copies of any material (i)
draft filings with, (ii) submissions to and (iii) correspondence (including Approvals) with,
Regulatory Authorities pertaining to the Development and/or Commercialization of a Licensed
Product in the Field under the Plans, and shall use reasonable efforts to afford the other
Party’s representatives an opportunity to actively participate in the drafting and review of
such material filings and submissions (including,

45

 

without limitation, all annual and
periodic safety reports for Licensed Products in the Field), and consistent with applicable
laws, to have up to two (2) representatives from the other Party attend and actively
participate in all material, pre-scheduled meetings, telephone conferences and/or
discussions with Regulatory Authorities to the extent such material meetings, telephone
conferences and/or discussions pertain to the Development and/or Commercialization of any
Licensed Product in the Field. Without limiting the foregoing, the Lead Regulatory Party
shall use Commercially Reasonable Efforts to provide the other Party on a timely basis with
all material information, data and materials reasonably necessary for the other Party to
participate in the preparation of the material filings and submissions referred to in this
paragraph (c), said items to be provided to the other Party in a timely manner. The Parties
will discuss in good faith any disputes on the contents of filings or submissions referred
to in this paragraph (c) to the Regulatory Authorities and disputes shall be submitted to
the JDC for timely resolution.

          (d) For each Licensed Product, the JDC shall develop and the JSC shall approve proposed
target Licensed Product labeling (“Target Labeling”) for use in the Territory.

          7.3 Regulatory Events. Each Party shall keep the other Party informed, commencing within
forty-eight (48) hours after notification (or other time period specified below), of any action by,
or notification or other information which it receives (directly or indirectly) from, any
Regulatory Authority, Third Party or other Governmental Authority, which:

          (a) raises any material concerns regarding the safety or efficacy of any Licensed
Product in the Field;

          (b) indicates or suggests a potential investigation or formal inquiry by any Regulatory
Authority in connection with the Development, Manufacture or Commercialization of a Licensed
Product in the Field under the Plans; provided, however, that each Party shall inform the
other Party of the foregoing no later than twenty-four (24) hours after receipt of a
notification referred to in this clause (b); or

          (c) is reasonably likely to lead to a recall or market withdrawal of any Licensed
Product in the Field anywhere in the Territory.

          Information that shall be disclosed pursuant to this Section 7.3 shall include, but not be
limited to the following matters with respet to Licensed Products:

          (i) Governmental Authority inspections of Manufacturing, Development,
distribution or other facilities;

          (ii) inquiries by Regulatory Authorities or other Governmental Authorities
concerning clinical investigation activities (including inquiries of investigators,
clinical research organizations and other related parties) or pharmacovigilance
activities, in each case, to the extent involving matters described in clauses (a),
(b) or (c) of this Section 7.3;

46

 

          (iii) receipt of a warning letter issued by a Regulatory Authority;

          (iv) an initiation of any Regulatory Authority or other Governmental Authority
investigation, detention, seizure or injunction; and

          (v) receipt of product complaints concerning actual or suspected Licensed
Product tampering, contamination, or mix-up (e.g., wrong ingredients).

          7.4 Pharmacovigilance and Product Complaints. While the Lead Regulatory Party shall be
responsible for managing pharmacovigilance and product complaints and for formulating and
implementing any related strategies, both Parties will cooperate with each other in order to
fulfill all regulatory requirements concerning pharmacovigilence and risk management plans and
product complaint reporting in all countries in which any Licensed Product is being developed,
manufactured, or commercialized anywhere in the Territory. Without limitation to the foregoing,
the Parties shall execute a Safety Data Exchange Agreement (“SDEA”) setting forth the
specific procedures to be used by the Parties to coordinate the investigation and exchange of
reports of adverse events/adverse drug reactions and Licensed Product complaints to ensure timely
communication to Regulatory Authorities and compliance with Laws.

          7.5 Regulatory Inspection or Audit. If a Regulatory Authority desires to conduct an
inspection or audit of a Party with regard to a Licensed Product in the Field, each Party agrees to
cooperate with the other and the Regulatory Authority during such inspection or audit, including by
allowing, to the extent practicable, a representative of the other Party to be present during the
applicable portions of such inspection or audit to the extent it relates to the Development,
Manufacture or Commercialization of a Licensed Product for use in the Field under this Agreement.
Following receipt of the inspection or audit observations of the Regulatory Authority (a copy of
which the receiving Party will promptly provide to the other Party), the Party in receipt of the
observations will prepare any appropriate responses; provided that the other Party, to the extent
practicable, shall have the right to review and comment on such responses to the extent they cover
or may be reasonably expected to adversely impact the Licensed Products in the Field in the
Territory, and the Party that received the observations shall consider in good faith the comments
made by such other Party. In the event the Parties disagree concerning the form or content of a
response, the Party that received the observations will decide the appropriate form and content of
the response. Without limiting the foregoing, each Party (and its Third Party subcontractors)
shall notify the other Party within forty-eight (48) hours of receipt of a notification from a
Regulatory Authority of the intention of such Regulatory Authority to audit or inspect facilities
used or proposed to be used for the Manufacture of Licensed Products for use in the Field under
this Agreement; provided that such notification shall
be given no later than twenty-four (24) hours prior to any such Regulatory Authority audit or
inspection.

          7.6 Recalls and Other Corrective Actions. Decisions with respect to any recall, market
withdrawal or other corrective action related to any Licensed Product in the Field in the Territory
shall be made only upon mutual agreement of the Parties, which agreement shall not be unreasonably
withheld or delayed; provided, however, that nothing herein shall prohibit either

47

 

Party from
initiating or conducting any recall or other corrective action mandated by a Governmental Authority
or Law. The Party that determines that a recall or market withdrawal of a Licensed Product in the
Field in the Territory may be required shall, within twenty-four (24) hours, notify the other Party
and, without limitation of and subject to the proviso in the immediately preceding sentence, the
Parties shall decide whether such a recall or market withdrawal is required. The Parties shall
cooperate with respect to any actions taken or public statements made in connection with any such
recall or market withdrawal. Expenses associated with such recalls will be treated as Other Shared
Expenses.

ARTICLE VIII

MANUFACTURING AND SUPPLY

          8.1 Manufacture and Supply of Clinical Supply Requirements of Formulated Bulk Product.
Until such time as Commercial Supply Requirements are being Manufactured, Regeneron will use
Commercially Reasonable Efforts to provide an adequate and timely supply of Formulated Bulk Product
for Clinical Supply Requirements of Licensed Products in the Field in the Territory in accordance
with the Manufacturing Plan. Regeneron may use its Manufacturing facilities or, subject to
Sanofi’s prior written approval, such approval not to be unreasonably withheld or delayed, Sanofi
or Third Parties to Manufacture such Formulated Bulk Product. If an entity other than Regeneron is
to be used to Manufacture Formulated Bulk Product for Clinical Supply Requirements, preference
shall be given to Sanofi or an Affiliate of Sanofi that is qualified to Manufacture the applicable
Licensed Product in accordance with applicable Good Practices and where the estimated Manufacturing
Cost is comparable to that of Third Party Manufacturers. The Formulated Bulk Product Manufactured
by or on behalf of Regeneron for Clinical Supply Requirements will be billed to Sanofi by Regeneron
at the Manufacturing Cost per Part I of Schedule 1 as a Development Cost. To the extent that
Regeneron maintains manufacturing capacity available for the Manufacture of Clinical Supply
Requirements, the cost of maintaining such capacity shall be included as a Development Cost to the
extent it is not included as a Manufacturing Cost.

          8.2 Finished Product Supply of Clinical Supply Requirements. Regeneron will timely
identify, and enter into an agreement with, a Third Party or Third Parties or Sanofi (or use its
own facilities, if Regeneron has such capabilities) to perform the filling, packaging, labeling and
testing of the Formulated Bulk Product and supply Finished Product for Clinical Supply Requirements
for Licensed Products for use under this Agreement. If an entity other than Regeneron is to be
used to perform filling, packaging, labeling or testing services related to Finished Product for
Clinical Supply Requirements, preference shall be given to Sanofi or an Affiliate of Sanofi that is
qualified to perform such services in accordance with applicable Good Practices and where the
estimated Manufacturing Cost is comparable to that of Third Parties. Such Finished Product for
Clinical Supply Requirements Manufactured on behalf of Regeneron
will be billed to Sanofi at the Manufacturing Cost as a Development Cost, in accordance with Part I
of Schedule 1.

          8.3 Manufacture and Supply of Commercial Supply Requirements.

     (a) The Parties, through the JMC and JSC, will determine whether a Party, or a Third
Party on behalf of a Party, will be responsible for Manufacturing and

48

 

supplying Commercial
Supply Requirements of Formulated Bulk Product and/or Finished Product for each Licensed
Product for use under this Agreement. The JMC shall use all reasonable efforts to make such
determination no later than ********************************. Such a notice (a
“Manufacturing Notice”) shall be irrevocable and shall be treated as a firm
commitment to supply such Formulated Bulk Product or Finished Product, as the case may be.
Preference will be given to having a Party or both Parties, rather than Third Parties,
Manufacture and supply Commercial Supply Requirements, provided that the Party is qualified
to Manufacture such Licensed Product in accordance with applicable Good Practices and on
terms mutually acceptable to the Parties. If both Parties desire to Manufacture and supply
such Commercial Supply Requirements, **********************. If one Party desires to
Manufacture and supply ******************************. If the Parties can not agree on
terms under which either or both Parties will Manufacture and supply Commercial Supply
Requirements of a Licensed Product, the JMC shall arrange for a Third Party to Manufacture
and supply such Commercial Supply Requirements.

     (b) Once Manufacture of Commercial Supply Requirements of a Licensed Product begins, or
is scheduled to begin, Manufacture of Clinical Supply Requirements of such Licensed Product
shall be coordinated with Manufacture of Commercial Supply Requirements of such Licensed
Product. Formulated Bulk Product and/or Finished Product Manufactured by or on behalf of a
Party for Commercial Supply Requirements, and for Clinical Supply Requirements that are
Manufactured in coordination with the Commercial Supply Requirements, will be billed at the
Manufacturing Cost described in Part II of Schedule 1 as a Commercial Supply Cost and
Clinical Supply Cost, respectively. If a Party has commercial scale capacity available in
anticipation of beginning to Manufacture Commercial Supply Requirements, the JMC shall
decide if such Party shall Manufacture any Clinical Supply Requirements even before it
begins to Manufacture Commercial Supply Requirements.

     (c) Any Third Party manufacturer of Commercial Supply Requirements or Clinical Supply
Requirements will be required to enter into a separate confidentiality agreement with
Regeneron prior to the transfer of the manufacturing operations from Regeneron to such Third
Party. All of Regeneron’s costs and expenses associated with the transfer of the
manufacturing operations and related Know-How to the Third Party manufacturer (or Sanofi, to
the extent that Sanofi manufactures all or part of the Commercial Supply Requirements or
Clinical Supply Requirements) will be billed as a Development Cost.

          8.4 Supply Agreement. The Parties shall enter into one or more clinical supply agreements
with respect to the quality assurance/quality control, forecasting, ordering and
delivery of Clinical Supply Requirements, which shall contain terms consistent with this Agreement.
At least ************************* of a Licensed Product, the Parties shall enter into separate
commercial supply agreements with respect to the quality assurance/quality control, forecasting,
ordering and delivery of Clinical Supply Requirements and Commercial Supply Requirements after the
First Commercial Sale, which shall contain terms consistent with this Agreement. Each supply
agreement will include as an annex thereto a customary quality

49

 

agreement containing terms and
conditions regarding quality assurance and Good Practices and provide for terms for forecasting,
ordering, delivery, payment and supply consistent with the terms of this Agreement.

          8.5 Process Development and Manufacturing Plans. The Parties, through the JMC, will
develop and update as necessary, for each Licensed Product, a Manufacturing Plan. The JMC shall be
responsible for deciding on process and technology selection, on process improvements and all
related process development activities which impact manufacturing. The JMC shall also be
responsible for all decisions relating to Manufacturing Formulated Bulk Product for Clinical Supply
Requirements of Licensed Products. Each Manufacturing Plan shall set forth the supply requirements
of a Licensed Product over an ensuing period of at ***************. The Manufacturing Plan will
include arrangements for the Manufacture of back-up Formulated Bulk Product for Licensed Product
requirements at a Party or a Third Party back-up Manufacturing facility. The Manufacturing Plan
(including each annual update thereto) shall be prepared by the JMC and approved by the JSC at
least two (2) months prior to the end of the then current Contract Year, except that the initial
Manufacturing Plan covering at least initial expected Clinical Supply Requirements for a Licensed
Product, to the extent not included in the Initial Development Plan, shall be approved by the JSC
within the initial Global Development Plan. The Parties shall design Manufacturing Plans to ensure
an adequate supply of Licensed Product and shall use Commercially Reasonable Efforts to perform
their responsibilities in accordance with the approved Manufacturing Plans.

          8.6 Manufacturing Shortfall. Each Party is required to provide prompt written notice to
the other Party if it reasonably determines that it will not, despite its using Commercially
Reasonable Efforts, be able to supply the agreed upon demand forecast for the Licensed Products set
forth in the Manufacturing Plan. Upon such notification, the matter will be referred to the JMC
and JSC to determine what, if any (and identify and establish, as quickly as possible, if
applicable) alternative supply source of Licensed Product (including the other Party) should be
utilized.

          8.7 Manufacturing Compliance. Each Party will use diligent efforts to Manufacture the
Formulated Bulk Product and Finished Product supplied under this Article VIII or, as applicable, to
ensure that the same is Manufactured by Third Parties in conformity with Good Practices and
applicable Laws. Each Party will timely notify and seek the approval of the other Party, which
approval shall not be unreasonably withheld or delayed, for any Manufacturing changes for the
Formulated Bulk Product or Finished Product that are reasonably likely to have an adverse impact on
(a) the quality of the Licensed Products supplied under this Agreement or (b) the regulatory status
of the Licensed Products in the Territory, including requirements to support or maintain any
Approvals. Each Party shall have the right to conduct inspections and audits of the other Party’s
facilities involved in the Manufacture of Licensed
Products in the Field pursuant to this Agreement at reasonable times and on reasonable prior notice
on terms to be agreed upon by the Parties. Moreover, each Party will use diligent efforts to
negotiate agreements that would allow the other Party to audit the facilities of Third Party
contractors (including Sanofi, if applicable) involved in the Manufacture of Licensed Products for
use in the Field under this Agreement.

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ARTICLE IX

PERIODIC REPORTS; PAYMENTS

          9.1 Development Costs. Sanofi shall be responsible for paying one hundred percent (100%)
of the total Development Costs for each Licensed Product incurred by or on behalf of Sanofi,
Regeneron and their respective Affiliates, except that Shared Phase 3 Trial Costs will be shared
eighty percent (80%) by Sanofi and twenty percent (20%) by Regeneron.
****************************************.

          9.2 Milestone Payments. In addition to the other payments contemplated herein, Sanofi
shall be obligated to pay the non-refundable, non-creditable milestone payments listed in Schedule
3 to Regeneron upon the occurrence of the applicable milestone event. Sanofi shall have thirty
(30) Business Days after the achievement of any such milestones to pay the corresponding amount to
Regeneron, in each case, which shall not be reduced by any withholding or similar taxes.

          9.3 Royalties. Any royalty amounts payable pursuant to Section 2.6(d) and 5.6 of this
Agreement shall be paid to the applicable Party for the period of time, as determined on an Opt-Out
Product-by-Opt-Out Product and country-by-country basis, commencing on the first commercial sale of
such Opt-Out Product and ****************** (the “Royalty Term”). During the Royalty
Term, the paying Party shall deliver to the other Party with each royalty payment a report
detailing in reasonable detail the information necessary to calculate the royalty payments due
under this Section 9.3 for such calendar quarter, including the following information, specified on
an Opt-Out Product-by-Opt-Out Product and country-by-country basis: (a) total gross invoiced
amount from sales of each such Opt-Out Product by the paying Party, its Affiliates and
sublicensees; (b) all relevant deductions from gross invoiced amounts to calculate Net Sales; (c)
Net Sales; and (d) royalties payable.

          9.4 Sharing of Profits from Licensed Products. Commencing on the Effective Date and
continuing during the Term, the Parties shall share the U.S. Profit Split in the United States, and
(ii) the Rest of World Profit Split in the Rest of World Countries, in each case, as described in
Schedule 2.

          9.5 Periodic Reports. Sanofi and Regeneron shall each prepare and deliver to the other
Party the periodic reports specified below:

          (a) Each Party shall deliver electronically the reports required to be delivered by it
pursuant to Section 5.4;

          (b) Within twenty (20) days following the end of each month, commencing with the month
in which First Commercial Sale occurs, Sanofi shall deliver
electronically to Regeneron a monthly detailed Net Sales report with monthly and
year-to-date sales for each Licensed Product in the Field in the Territory by country in
United States Dollars;

          (c) Within forty-five (45) days following the end of each Quarter, commencing with the
Quarter in which First Commercial Sale occurs, Sanofi shall

51

 

deliver electronically to
Regeneron a written report setting forth, on a country-by-country basis in the Territory for
such Quarter (i) the Net Sales of each Licensed Product in local currency and in United
States Dollars, (ii) Licensed Product quantities sold in the Field by dosage form and unit
size and (iii) gross Licensed Product sales in the Field and an accounting of the deductions
from gross sales permitted by the definition of Net Sales;

          (d) Within forty-five (45) days following the end of each Quarter, each Party that has
incurred any Other Shared Expenses or Shared Commercial Expenses in that Quarter shall
deliver electronically to the other Party a written report setting forth in reasonable
detail the Other Shared Expenses and/or Shared Commercial Expenses incurred by such Party in
such Quarter on a country-by-country and Licensed Product-by-Licensed Product basis,
including whether any such expenses are also included in the reports delivered pursuant to
clause (e) below;

          (e) Within forty-five (45) days after the end of each Quarter, commencing with the
Quarter in which First Commercial Sale in a Reporting Country/Region occurs (or such earlier
agreed upon calendar Quarter, if appropriate), Sanofi shall provide to Regeneron, in
electronic form, for each Reporting Country/Region, and Regeneron shall provide to Sanofi,
in electronic form, for each Co-Commercialization Country, a report summarizing in
reasonable detail the marketing, detailing, selling and promotional activities undertaken by
a Party (or its Affiliates) during the previous Quarter in such Reporting/Country Region
and/or Co-Commercialization Country; and

          (f) Within sixty (60) days following the end of each Quarter, Sanofi shall deliver
electronically to Regeneron a Consolidated Payment Report in respect of such Quarter,
combining the information reported by each Party pursuant to this Article IX and showing its
calculations in accordance with Schedule 2 of the amount of any payments to be made by the
Parties hereunder for such Quarterly period as contemplated by Section 9.5 (including, as
applicable, showing the calculation of the U.S. Profit Split and Rest of World Profit Split)
and, if applicable, providing for the netting of such payments.

     All reports referred to in this Section 9.5 shall be in such form, format and level of detail
as may be approved by the JFC. Unless otherwise agreed by the JCC, the financial data in the
reports will include calculations in local currency and United States Dollars.

          9.6 Funds Flow. The Parties shall make Quarterly True-Up payments as set forth in Schedule
2. If Sanofi is the Party owing the Quarterly True-Up payment based on the calculations in the
applicable Consolidated Payment Report, it shall, subject to Section 9.12, make such payment to
Regeneron within fifteen (15) days after its delivery to Regeneron of such
Consolidated Payment Report. If Regeneron is the Party owing the Quarterly True-Up payment based
on the calculations in the applicable Consolidated Payment Report, it shall, subject to Section
9.12, make such payment to Sanofi within fifteen (15) days after its receipt of such Consolidated
Payment Report from Sanofi. Notwithstanding the foregoing, no later than fifty-five (55) days
after the end of each Quarter, Sanofi shall pay Regeneron fifty percent (50%) of the amount of
royalties or other amounts payable under any License (to the extent attributable to

52

 

the
Manufacture, Development and/or Commercialization of Licensed Products under the Plans for the
Territory) to which Regeneron is a party on account of the Commercialization of Licensed Products
in the Field in the Territory and provide such supporting documentation required by such License,
as the case may be.

          9.7 Invoices and Documentation. The JFC shall approve the form of any necessary
documentation relating to any payments hereunder so as to afford the Parties appropriate accounting
treatment in relation to any of the transactions or payments contemplated hereunder.

          9.8 Payment Method and Currency. All payments under this Agreement shall be made by bank
wire transfer in immediately available funds to an account designated by the Party to which such
payments are due. All sums due under this Agreement shall be payable in United States Dollars. In
those cases where the amount due in United States Dollars is calculated based upon one or more
currencies other than United States Dollars, such amounts shall be converted to United States
Dollars using the average of the buying and selling exchange rates for conversion of the applicable
foreign currency into United States Dollars, using the spot rates (the “Closing Mid-Point Rates”
found in the “Dollar spot forward against the Dollar” table published by The Financial Times, or
any other publication as agreed to by the Parties) from the last Business Day of the preceding
month.

          9.9 Late Payments. The Parties agree that, unless otherwise mutually agreed by the Parties
or otherwise provided in this Agreement, amounts due by one Party to the other shall be payable to
a bank account, details of which are to be communicated by the receiving Party. All late payments
under this Agreement shall earn interest, to the extent permitted by applicable Law, from the date
due until paid at a rate equal to the thirty (30) day London Inter-Bank Offering Rate (LIBOR) U.S.
Dollars, as quoted in The Wall Street Journal (Eastern Edition) effective for the date on which the
payment was due, plus ********** (such sum being referred to as the “Default Interest
Rate”).

          9.10 Taxes. Except as set forth in Section 9.2, any withholding or other taxes that either
Party or its Affiliates are required by Law to withhold or pay on behalf of the other Party, with
respect to any payments to such other Party hereunder, shall be deducted from such payments and
paid to the appropriate tax authority contemporaneously with the remittance to the other Party;
provided, however, that the withholding Party shall promptly furnish to the other Party proper
evidence or other reasonable documentation of the taxes so paid. Each Party shall cooperate with
the other and furnish to the other Party appropriate documents to secure application of the most
favorable rate of withholding tax under applicable Law (or exemption from such withholding tax
payments, as applicable). Without limiting the foregoing, each Party agrees to make all lawful and
reasonable efforts to minimize any such taxes, assessments and
fees and will claim on the other Party’s behalf the benefit of any available treaty on the
avoidance of double taxation that applies to any payments hereunder to such other Party.

          9.11 Adjustments to FTE Rates. Notwithstanding anything herein to the contrary, upon the
request of either Party, the Parties shall meet to review the accuracy of an applicable FTE rate in
any country (e.g., Sales Force FTE Rate, Medical Post-Approval FTE Rate, Development FTE
Rate, etc.). The Parties agree to share reasonable supporting documents

53

 

and materials in
connection with an assessment of the applicable FTE rate and to determine in good faith whether to
adjust the rate(s) in any country.

          9.12 Resolution of Payment Disputes. In the event there is a dispute relating to any of
the payment obligations or reports under this Article IX, the Party with the dispute shall have its
representative on the JFC provide the other Party’s representative on the JFC with written notice
setting forth in reasonable detail the nature and factual basis for such good faith dispute and the
Parties, through the JFC, will seek to resolve the dispute as promptly as possible, but no later
than ten (10) days after such written notice is received. In the event that no resolution is
reached by the JFC, the matter shall be referred to the JSC in accordance with Section 3.11(a).
Notwithstanding any other provision of this Agreement to the contrary, the obligation to pay any
reasonably disputed amount shall not be deemed to have been triggered until such dispute is
resolved hereunder, provided that all amounts that are not in dispute shall be paid in accordance
with the provisions of this Agreement.

ARTICLE X

DISPUTE RESOLUTION

          10.1 Resolution of Disputes. The Parties recognize that disputes as to certain matters may
from time to time arise which relate to either Party’s rights and obligations hereunder. It is the
objective of the Parties to comply with the procedures set forth in this Agreement and to use all
reasonable efforts to facilitate the resolution of such disputes in an expedient manner by mutual
agreement.

          10.2 Governance Disputes. Disputes, controversies and claims related to matters intended
to be decided within the governance provisions of this Agreement set forth in Article III
(“Governance Disputes”) shall be resolved pursuant to Article III and, to the extent such
matters constitute Technical Development Matters, a dispute referred to in Section 14.2(b) or a
Budget Dispute, Section 10.4, except to the extent any such dispute, controversy or claim
constitutes a Legal Dispute, in which event the provisions of Section 10.3 shall apply. For the
purposes of this Agreement, the term “Technical Development Matter” shall mean any dispute
concerning a Party’s refusal to approve a clinical trial proposed pursuant to Section 2.6(b).

          10.3 Legal Disputes. The Parties agree that, subject to Sections 10.5 and 16.2, they shall
use all reasonable efforts, through their participation in the JSC in the first instance, to
resolve any Legal Dispute arising after the Effective Date by good faith negotiation and
discussion. In the event that the JSC is unable to resolve any such Legal Dispute within five (5)
Business Days of receipt by a Party of notice of such Legal Dispute, either Party may submit the
Legal Dispute to the Executive Officers for resolution. In the event the Executive Officers are
unable to resolve any such Legal Dispute within the time period set forth in Section 3.11(b), the
Parties shall be free to pursue any rights and remedies available to them at law, in equity or
otherwise, subject, however, to Section 20.1 and Section 20.15.

          10.4 Expert Panel.

     (a) In the event of a dispute between the Parties concerning a Technical Development
Matter, any Budget Dispute or a dispute referred to in Section

54

 

14.2(b) that cannot be
resolved by the Executive Officers pursuant to Section 3.11(b) (other than a Legal Dispute),
either Party may by written notice to the other Party require the specific issue in dispute
to be submitted to a panel of experts (“Expert Panel”) in accordance with this
Section 10.4 (for the avoidance of doubt, it is understood that, subject to Section 10.4(e),
in the case of a Budget Dispute first submitted to the Expert Panel, the specific issue
shall be limited to the overall commercial reasonableness of the Disputed Budget). Such
notice shall contain a statement of the issue forming the basis of the dispute, the position
of the moving Party as to the proper resolution of that issue and the basis for such
position. Within fifteen (15) days after receipt of such notice, the responding Party shall
submit to the moving Party a statement of its conception of the specific issue in question,
its position as to the proper resolution of that issue and the basis for such position.

     (b) Within fifteen (15) days of the responding Party’s response, each Party shall
appoint to the Expert Panel an individual who (i) has expertise in the pharmaceutical or
biotechnology industry and the specific matters at issue (or, in the case of a dispute
regarding an audit as referred to in Section 14.2(b), expertise in accounting and auditing
with respect to the development and commercialization of pharmaceutical products), (ii) is
not a current or former director, employee or consultant of such Party or any of its
Affiliates, or otherwise has not received compensation or other payments from such Party (or
its Affiliates) for the past five (5) years and (iii) has no known personal financial
interest or benefit in the outcome or resolution of the dispute, and the appointing Party
shall give the other Party written notice of such appointment; provided that for such
appointment to be effective and for such individual to serve on the Expert Panel, such
individual must deliver to the other Party a certificate confirming that such individual
satisfies the criteria set forth in clauses (i) through (iii) above, disclosing any
potential conflict or bias and certifying that, as a member of the Expert Panel, such
individual is able to render an independent decision.

     (c) Within fifteen (15) days of the appointment of the second (2nd) expert, the two (2)
appointed experts shall agree on an additional expert who meets the same criteria as
described above, and shall appoint such expert as chair of the Expert Panel. If the
Party-appointed experts fail to timely agree on a third (3rd) expert, then upon the written
request of either Party, each Party-appointed expert shall, within ten (10) days of such
request, nominate one expert candidate and the CPR Institute for Dispute Resolution shall,
within ten (10) days of receiving the names of the Parties’ respective nominees, select one
of those experts to serve as the chair of the Expert Panel. Each expert shall agree, prior
to his or her appointment, to render a decision as soon as practicable after the appointment
of the full Expert Panel.

     (d) Within seven (7) days of the appointment of the third (3rd) expert, the Expert
Panel shall hold a preliminary meeting or teleconference with the Parties or their
representatives and shall designate a time and place for a hearing of the Parties on the
dispute and the procedures to be utilized at the hearing. The Parties may agree in writing
to waive the hearing and have the Expert Panel reach a decision on the basis of written
submissions alone. The Expert Panel may order the Parties to produce any documents or

55

 

documents or information which are relevant to the dispute. All such documents or
information shall be provided to the other Party and the Expert Panel as expeditiously as
possible but no later than one (1) week prior to the hearing (if any), along with the names
of all witnesses who will testify at the hearing and a brief summary of their testimony.
The hearing shall be held in New York, NY, unless otherwise agreed by the Parties, and
shall take place as soon as possible but no more than forty-five (45) days after the
appointment of the third expert, unless the Parties otherwise agree in writing or the
Expert Panel agrees to extend such time period for good cause shown. The hearing shall last
no more than one (1) day, unless otherwise agreed by the Parties or the Expert Panel agrees
to extend such time period for good cause shown. After the conclusion of all testimony (or
if no hearing is held after all submissions have been received from the Parties), at a time
designated by the Expert Panel no later than seven (7) days after the close of the hearing
or the receipt of all submissions, each Party shall simultaneously submit to the Expert
Panel and exchange with the other Party its final proposed resolution (which, in the case
of a Budget Dispute first submitted to the Expert Panel shall be a Party’s proposed
resolution that the Disputed Budget either is or is not overall commercially reasonable).

          (e) In rendering the final decision with respect to a Budget Dispute first submitted
to the Expert Panel, the Expert Panel shall be limited to determining the overall
commercial reasonableness of the Disputed Budget. If the Expert Panel determines that such
Disputed Budget is overall commercially reasonable, then such Budget Dispute shall be
deemed finally resolved and such resolution shall be binding on the Parties. However, if
the Expert Panel determines that such Disputed Budget is not overall commercially
reasonable, then the Expert Panel shall, within fifteen (15) days after such determination,
render a final decision as to what modifications could be made to such Disputed Budget in
order for it to be overall commercially reasonable (a “Budget Modification
Decision”). In connection with reaching a Budget Modification Decision, the Expert
Panel shall order the Parties to produce any documents or other information which are
relevant to such final decision, and the Parties shall submit such documents or other
information, together with their respective proposed resolutions which shall consist of
their respective proposed modifications to the Disputed Budget in order for it to be
overall commercially reasonable, at least seven days prior to the date a Budget
Modification Decision is required to be rendered as provided above. In rendering the final
decision (which, for other than a Budget Modification Decision, shall be rendered no later
than fifteen (15) days after receipt by the Expert Panel of the Parties’ respective
proposed resolutions, and for a Budget Modification Decision, shall be rendered no later
than seven days after receipt by the Expert Panel of the Parties’ respective proposed
resolutions), the Expert Panel shall be limited to choosing a resolution proposed by a
Party without modification; provided, however, that in no event shall the Expert Panel
render a decision that is inconsistent with the Collaboration Purpose and the Parties’
intentions as set forth in this Agreement. The agreement
of two (2) of the three (3) experts shall be sufficient to render a decision and the
Parties shall abide by such decision.

          (f) The decision of the Expert Panel shall be final and binding on the Parties and may
be entered and enforced in any court having jurisdiction. Each Party

56

 

shall bear the cost
of its appointee to the Expert Panel and the Parties shall share equally the costs of the
third expert.

          10.5 No Waiver. Nothing in this Article X or elsewhere in this Agreement shall prohibit either
Party from seeking and obtaining immediate injunctive or other equitable relief if such Party
reasonably believes that it will suffer irreparable harm from the actions or inaction of the other.

ARTICLE XI

TRADEMARKS AND CORPORATE LOGOS

          11.1 Corporate Names. Each Party and its Affiliates shall retain all right, title and interest
in and to their respective corporate names and logos.

          11.2 Selection of Product Trademarks. For each Licensed Product, the JCC shall select one
Product Trademark for use in the Field throughout the Territory, unless such Product Trademark is
prohibited by law in any country in the Territory or the JCC determines that a different Product
Trademark should be used in particular countries or Regions to maximize the commercial potential of
such Licensed Product. Once a Product Trademark has been selected by the JCC, the Parties shall
enter into an agreement or, in the alternative, shall amend this Agreement as the Parties may
agree, in order to address the Parties’ respective rights and obligations with respect to such
Product Trademark. Each Licensed Product in the Field shall be promoted and sold in the Territory
under the applicable Product Trademark(s), trade dress and packaging approved by the JCC.

          11.3 Ownership of Product Trademarks. Unless otherwise mutually agreed between the Parties, and
subject to Sections 11.4 and 11.5, Sanofi (or its local Affiliates, as appropriate) shall own and
retain all right, title and interest in and to Product Trademark(s), together with all associated
domain names and all goodwill related thereto in all countries in the Territory.

          11.4 Prosecution and Maintenance of Product Trademark(s). Sanofi will use Commercially
Reasonable Efforts to prosecute and maintain the Product Trademark(s) in all countries in the
Territory. Notwithstanding the foregoing, in the event Sanofi elects not to prosecute or maintain
any Product Trademark(s) in any country in the Territory, Sanofi shall provide reasonable prior
written notice to Regeneron of its intention not to prosecute or maintain any such Product
Trademark in such country in the Territory, and Regeneron shall have the right to do so on behalf
of Sanofi for use with Licensed Products, subject to consultation and cooperation with Sanofi. All
Out-of-Pocket Costs incurred in the filing, prosecution and maintenance of Product Trademarks
as provided in this Section 11.4 shall be shared by the Parties as part of Shared Commercial
Expenses.

          11.5 License to the Product Trademark(s). Sanofi hereby grants to Regeneron a co-exclusive
license (non-exclusive only with respect to Regeneron) to use the Product Trademark(s) for the
Licensed Products solely for the purposes of Regeneron’s Development, Manufacturing, and, if
applicable, Co-Promotion of Licensed Products, or other Regeneron Commercialization activities with
respect to Licensed Products if agreed to by Sanofi or set forth

57

 

in any Plans, subject to the terms
and conditions of this Agreement. Consistent with Section 4.4 of this Agreement, neither Party
shall license (or in the case of Regeneron, sublicense) rights to use, or otherwise transfer
ownership of the Product Trademark(s) without the prior written consent of the other Party, such
consent not to be unreasonably withheld or delayed. Sanofi shall only utilize the Product
Trademark(s) on approved Promotional Materials, on the Licensed Products as needed and on or other
approved product-related materials for the Licensed Products in the Field in the Territory for the
purposes contemplated herein, and all use by Sanofi or its Affiliates or Sublicensees of the
Product Trademark(s) shall be in accordance with (a) rules established by the JCC and (b) quality
standards established by the JCC which are reasonably necessary in order to preserve the validity
and enforceability of the Product Trademark(s). Each Party agrees that at no time during the Term
will it or any of its Affiliates attempt to use or register any trademarks, trade dress, service
marks, trade names or domain names confusingly similar to the Product Trademark(s) in relation to a
product that is a Licensed Product, or take any other action which damages or dilutes the rights
to, or goodwill associated with, the Product Trademark(s). Upon request by either Party, the other
Party shall (or shall cause its Affiliates, as appropriate, to) execute such documents as may
reasonably be required for the purpose of recording with any Governmental Authority the license, or
a recordable version thereof, referred to above in this Section 11.5.

          11.6 Use of Corporate Names. Sanofi (through its Affiliates, as appropriate) shall use
Commercially Reasonable Efforts to include Regeneron’s name with equal prominence on materials
related to each Licensed Product in the Field (including, without limitation, package inserts,
packaging, trade packaging, samples and all Promotional Materials used or distributed in connection
with such Licensed Product), unless to do so would be prohibited under applicable Laws; provided,
however, in the case of multi-product materials that refer to a Licensed Product in the Field as
well as other pharmaceutical products, the prominence of Regeneron’s name shall be commensurate
with the relative prominence of the Licensed Product in such materials. Each Party grants to the
other Party (and its Affiliates) the right, free of charge, to use its name and logo on package
inserts, packaging, trade packaging, samples and all Promotional Materials used or distributed in
connection with the applicable Licensed Product in the Field in the Territory during the Term and
thereafter with respect to Promotional Materials, package inserts, packaging, labeling, trade
packaging and samples, only for the time period and solely to the extent necessary to exhaust the
existing inventory of Licensed Product (including packaging materials for such Licensed Product)
and Promotional Materials containing such name or logo. During the Term, each Party shall submit
samples of each such package inserts, packaging, trade
packaging, etc. to such other Party for its prior approval, which approval shall not be
unreasonably withheld or delayed, at least thirty (30) days before dissemination of such materials.
Failure of the receiving Party to object within such thirty (30) day period shall constitute
approval of the submitting Party’s package inserts, packaging, trade packaging, etc.

ARTICLE XII

NEWLY CREATED INVENTIONS AND KNOW-HOW

          12.1 Ownership of Newly Created Intellectual Property.

          (a) Subject to Section 12.1(e), each Party (and each Party’s respective Affiliates)
shall exclusively own all intellectual property (including, without limitation,

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Know-How,
Patents and Patent Applications and copyrights) discovered, invented, authored or otherwise
created in connection with the Collaboration solely by such Party, its Affiliates,
employees, agents and consultants (“Sole Inventions”). Sole Inventions made solely
by Sanofi, its Affiliates, employees, agents and consultants are referred to herein as
“Sanofi Sole Inventions”. Sole Inventions made solely by Regeneron, its
Affiliates, employees, agents and consultants are referred to herein as “Regeneron Sole
Inventions”. The Parties agree that nothing in this Agreement, and no use by a Party
of the other Party’s Intellectual Property pursuant to this Agreement, shall vest in a
Party any right, title or interest in or to the other Party’s Intellectual Property, other
than the license rights expressly granted hereunder. Any remuneration payable under
applicable law to an inventor and costs associated with determining such remuneration shall
be treated as Other Shared Expenses.

          (b) The Parties shall jointly own all intellectual property (including, without
limitation, Know-How, Patents and Patent Applications and copyrights) discovered, invented,
authored or otherwise created under the Collaboration during the Term that is invented or
authored jointly by an individual or individuals having an obligation to assign such
intellectual property to Sanofi or its Affiliate (or for which ownership vests in Sanofi or
its Affiliate by operation of law), on the one hand, and an individual or individuals
having an obligation to assign such intellectual property to Regeneron or its Affiliate (or
for which ownership vests in Regeneron or its Affiliate by operation of Law), on the other
hand, on the basis of each Party (or its Affiliate) having an undivided interest in the
whole (“Joint Inventions”).

          (c) Notwithstanding the foregoing in Section 12.1(b), (i) for purposes of determining
whether a patentable invention is a Sanofi Sole Invention, a Regeneron Sole Invention or a
Joint Invention, questions of inventorship shall be resolved in accordance with United
States patent laws, (ii) for purposes of determining whether a copyrighted work is a Sanofi
Sole Invention, a Regeneron Sole Invention or a Joint Invention, questions of copyright
authorship shall be resolved in accordance with United States copyright laws and (iii) for
purposes of determining whether Know-How (other than copyrighted
work and Patent Applications) is a Sanofi Sole Invention, a Regeneron Sole Invention
or a Joint Invention, questions of authorship or inventorship shall be resolved in
accordance with the laws of the State of New York, United States.

          (d) To the extent that any right, title or interest in or to any intellectual property
discovered, invented, authored or otherwise created under the Collaboration during the Term
vests in a Party or its Affiliate, by operation of Law or otherwise, in a manner contrary
to the agreed upon ownership as set forth in this Agreement, such Party (or its Affiliate)
shall, and hereby does, irrevocably assign to the other Party any and all such right, title
and interest in and to such intellectual property to the other Party without the need for
any further action by any Party.

          (e) Subject to the other terms and conditions of this Agreement (other than Section
12.1(a)), to the extent permitted under any relevant Third Party agreement, each Party
agrees that all Know-How, other than Excluded Know-How Rights, discovered, invented,
authored or otherwise created by it (or its Affiliate) after the

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Effective Date directly in
connection with the performance of the research and clinical activities approved by the
JDC, in each case, as included in the Global Development Plans shall be Joint Inventions.
Each Party agrees to execute all necessary documentation to reflect the foregoing. As used
above, the term “Excluded Know-How Rights” shall mean any Know-How claiming or
covering composition (including any formulation) of a Licensed Product, including, for the
avoidance of doubt, any manufacturing and/or cell line related intellectual property. For
further clarity, nothing in this Section 12.1(e) shall be construed to grant either Party
any rights to Patents or Know-How of the other Party discovered, invented, authored or
otherwise created by it outside the performance of the research activities approved by the
JDC and/or the clinical development activities approved by the JDC, in each case, as
included in Global Development Plans.

          (f) The Parties hereby agree that each Party’s use of the Joint Inventions is governed
by the terms and conditions of this Agreement shall be governed as follows: each Party’s
interest in the Joint Inventions may be sublicensed to Third Parties, and any ownership
rights therein transferred, in whole or in part, by each Party without consent of the other
Party (unless otherwise prohibited by this Agreement); provided that (i) each of the
Parties acknowledges that it receives no rights to any Intellectual Property of the other
Party underlying or necessary for the use of any Joint Invention, except as may be
expressly set forth in Article IV, (ii) each Party agrees not to transfer any of its
ownership interest in any of the Joint Inventions without securing the transferee’s written
agreement to be bound by the terms of this Section 12.1(e) and (iii) nothing in this
Article XII shall relieve a Party or its Affiliates of their obligations under Article XVI
with respect to confidential Party Information provided by the other Party or such other
Party’s Affiliates. Each of the Parties (or its Affiliate), as joint owner of the Joint
Inventions, agrees to cooperate with any enforcement actions brought by the other joint
owner(s) against any Third Parties, and further
agrees not to grant any licenses to any such Third Parties against which such
enforcement actions are brought during the time of such dispute, without the prior written
consent of the other joint owner(s), such consent not to be unreasonably withheld. Neither
Party hereto shall have the obligation to account to the other Party for any revenues or
profits obtained from any transfer of its interest in, or its use, sublicense or other
exploitation of, the Joint Inventions outside the scope of the Collaboration. The
provisions governing Joint Inventions set forth in this Section 12.1(e) shall survive the
expiration or termination of this Agreement.

          12.2 Prosecution and Maintenance of Patent Rights.

          (a) Regeneron shall prepare, file, prosecute and maintain Patents and Patent
Applications (as applicable) included in the Regeneron Patent Rights in the Territory.
Regeneron shall undertake such activities using outside counsel reasonably acceptable to
Sanofi except that all provisionals, the priority application based thereon and the
corresponding PCT may be prepared and filed by Regeneron’s in-house counsel. Regeneron
shall confer with and keep Sanofi reasonably informed regarding the status of such
activities. In addition, Regeneron shall have the following obligations with respect to
the filing, prosecution and maintenance of Regeneron Patent Rights: (i) Regeneron shall
provide to Sanofi for review and comment a substantially completed draft of any

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priority
Patent Application in the Territory at least thirty (30) days prior to the filing of any
such priority Patent Application by Regeneron and incorporate any reasonable comment from
Sanofi within such thirty (30) day period unless Regeneron reasonably believes that such
comments will adversely affect the Patent Application or resulting Patent (it being
understood that the Parties will discuss any points of disagreement and work to resolve
disagreements during this thirty (30) day period); (ii) Regeneron shall provide Sanofi
promptly with copies of all material communications received from or filed in patent
offices in the Territory with respect to such filings; (iii) Regeneron shall consult with
Sanofi promptly following the filing of the priority Patent Applications in the Territory
to mutually determine in which countries in the Territory it shall file convention Patent
Applications, provided, however, applications shall be filed in at least
******************************************** (the “Patent Jurisdictions”) unless
otherwise agreed in writing; and (iv) Regeneron shall consult with Sanofi a reasonable time
prior to taking or failing to take action that would materially affect the scope or
validity of rights under any Patent Applications or Patents in the Field (including but not
limited to substantially narrowing or canceling any claim without reserving the right to
file a continuing or divisional Patent Application, abandoning any Patent or not filing or
perfecting the filing of any Patent Application in any country). In the event that
Regeneron desires to abandon any Patent included in the Regeneron Patent Rights in the
Territory, Regeneron shall provide reasonable prior written notice to Sanofi of such
intention to abandon (which notice shall, in any event, be given no later than sixty (60)
days prior to the next deadline for any action that may be taken with respect to such
Regeneron Patent with the applicable patent office) and Sanofi shall have the right, but
not the obligation, to assume responsibility for the
prosecution and maintenance thereof, in Regeneron’s name or Sanofi’s name at Sanofi’s
sole discretion, unless, with respect to any such Patent Applications that are unpublished,
Regeneron notifies Sanofi that Regeneron would prefer to maintain the subject matter of
such Patent Application as a trade secret and Sanofi agrees in writing.

          (b) Sanofi shall prepare, file, prosecute and maintain Patents and Patent Applications
(as applicable) included in the Sanofi Patent Rights in the Territory and shall confer with
and keep Regeneron reasonably informed regarding the status of such activities. In
addition, Sanofi shall have the following obligations with respect to the filing,
prosecution and maintenance of Sanofi Patent Rights: (i) Sanofi shall provide to Regeneron
for review and comment a copy of a substantially completed draft of any priority Patent
Application in the Territory at least thirty (30) days prior to the filing of any such
priority Patent Application by Sanofi and incorporate any reasonable comment from Regeneron
unless Sanofi reasonably believes that such comments will adversely affect the Patent
Application or resulting Patent (it being understood that the Parties will discuss any
points of disagreement and work to resolve disagreements during this thirty (30) day
period); (ii) Sanofi shall provide Regeneron promptly with copies of all material
communications received from or filed in patent offices with respect to such filings; (iii)
Sanofi shall consult with Regeneron promptly following the filing of the priority Patent
Applications in the Territory to mutually determine in which countries in the Territory it
shall file convention Patent Applications, provided, however, applications shall be filed
in at least the Patent Jurisdictions unless otherwise agreed in writing; and (iv) Sanofi
shall

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consult with Regeneron a reasonable time prior to taking or failing to take action
that would materially affect the scope or validity of rights under any Patent Applications
or Patents in the Field (including but not limited to substantially narrowing or canceling
any claim without reserving the right to file a continuing or divisional Patent
Application, abandoning any Patent or not filing or perfecting the filing of any Patent
Application in any country). In the event that Sanofi desires to abandon any Patent
included in the Sanofi Patent Rights in the Territory, Sanofi shall provide reasonable
prior written notice to Regeneron of such intention to abandon (which notice shall, in any
event, be given no later than sixty (60) days prior to the next deadline for any action
that may be taken with respect to such Sanofi Patent with the applicable patent office) and
Regeneron shall have the right, but not the obligation, to assume responsibility for the
prosecution and maintenance thereof in Sanofi’s name, unless, with respect to any such
Patent Applications that are unpublished, Sanofi notifies Regeneron that Sanofi would
prefer to maintain the subject matter of such Patent Application as a trade secret and
Regeneron agrees in writing.

          (c) With respect to any Joint Patent Rights, the Parties shall consult with each other
regarding the filing, prosecution and maintenance of any Patents and Patent Applications,
and responsibility for such activities shall be the obligation of the Controlling Party.
The Controlling Party shall undertake such filings, prosecutions and maintenance in the
names of both Parties as co-owners
through outside counsel reasonably acceptable to the non-Controlling Party, except
that the Controlling Party may prepare and file all provisional applications, priority
applications based thereon and the corresponding PCTs using in-house counsel. The
Controlling Party shall have the following obligations with respect to the filing,
prosecution and maintenance of Patent Applications and Patents under any such Joint Patent
Rights: (i) the Controlling Party shall provide the non-Controlling Party with notice and
a copy of a substantially completed draft of any priority Patent Application at least
thirty (30) days prior to the filing of any such priority Patent Application by the
Controlling Party and incorporate any reasonable comment provided by the non-Controlling
Party within such thirty (30) day period (it being understood that the Parties will discuss
any points of disagreement and work to resolve disagreements during this thirty (30) day
period; (ii) the Controlling Party shall notify the non-Controlling Party prior to the
filing of a Patent Application by the Controlling Party; (iii) the Controlling Party shall
consult with the non-Controlling Party promptly following the filing of the priority Patent
Application to mutually determine in which countries it shall file convention Patent
Applications provided, however, applications shall be filed in at least the Patent
Jurisdictions unless otherwise agreed in writing; (iv) the Controlling Party shall provide
the non-Controlling Party promptly with copies of all material communications received from
or filed in patent offices with respect to such filings and the Parties use all reasonable
efforts to reach agreement in a timely manner with respect to all material responses and
amendments; and (v) the Controlling Party shall provide the non-Controlling Party a
reasonable time prior to taking or failing to take action that would affect the scope or
validity of rights under any Patent Applications or Patents, but in no event less than
sixty (60) days prior to the next deadline for any action that may be taken with the
applicable patent office (including but not limited to substantially narrowing or canceling
any claim without reserving the

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right to file a continuing or divisional Patent
Application, abandoning any Patent or not filing or perfecting the filing of any Patent
Application in any country), with notice of such proposed action or inaction so that the
non-Controlling Party has a reasonable opportunity to review and make comments, and take
such actions as may be appropriate in the circumstances. In the event that the Controlling
Party materially breaches the foregoing obligations and such breach is not cured within
thirty (30) days of a written notice from the non-Controlling Party to the Controlling
Party describing such breach, or in the event that the Controlling Party fails to undertake
the filing of a Patent Application within the earlier of (i) ninety (90) days of a written
request by the non-Controlling Party to do so, and (ii) sixty (60) days prior to the
anticipated filing date, the non-Controlling Party may assume the Controlling Party’s
responsibility for filing, prosecution and maintenance of any such Joint Patent Right, and
will thereafter be deemed the Controlling Party for purposes hereof. Notwithstanding the
foregoing, the Controlling Party may withdraw from or abandon any Patent or Patent
Application relating to any Joint Patent Rights on thirty (30) days’ prior written notice
to the other Party (provided that such notice shall be given no later than sixty (60) days
prior to the next deadline for any action that may be taken with respect to such Patent or
Patent Application with
the applicable patent office), providing the non-Controlling Party a free-of-charge
option to assume the prosecution or maintenance thereof.

          (d) Each Party agrees to cooperate with the other with respect to the preparation,
filing, prosecution and maintenance of Patents and Patent Applications pursuant to this
Section 12.2, including, without limitation, the execution of all such documents and
instruments and the performance of such acts (and causing its relevant employees to execute
such documents and instruments and to perform such acts) as may be reasonably necessary in
order to permit the other Party to continue any preparation, filing, prosecution or
maintenance of Joint Patent Rights that such Party has elected not to pursue as provided
for in Section 12.2(c). The JCC, with the approval of the JSC, will determine which of the
Sanofi Patent Rights, Regeneron Patent Rights and Joint Patent Rights for which to seek an
extension of term and the applicable Party will file for said patent term extension.

          (e) All Out-of-Pocket Costs incurred in the filing, prosecution and maintenance of any
Sanofi Patent Rights, Regeneron Patent Rights and Joint Patent Rights in the Territory for
use in the Field, and any extensions thereof, shall be treated as Other Shared Expenses.

          12.3 Interference, Opposition and Reissue.

          (a) Each Party will notify the other within ten (10) days of receipt by such Party of
information concerning the request for, or filing or declaration of, any interference,
opposition or reexamination relating to Regeneron Patent Rights, Sanofi Patent Rights or
Joint Patent Rights in the Territory. The Parties will thereafter consult and cooperate
fully to determine a course of action with respect to any such proceeding. The Parties
will reasonably consult with one another in an effort to agree with respect to decisions on
whether to initiate or how to respond to such a proceeding, as applicable, and the course
of action in such proceeding, including settlement negotiations and terms,

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provided that if
such agreement cannot be reached promptly, such decisions will be made (i) with respect to
Regeneron Patent Rights, by Regeneron in consultation with Sanofi, (ii) with respect to
Sanofi Patent Rights, by Sanofi in consultation with Regeneron and (iii) with respect to
Joint Patent Rights, jointly by the Parties.

          (b) All Out-of-Pocket Costs incurred in connection with any interference, opposition,
reissue or reexamination proceeding relating to the Regeneron Patent Rights, Sanofi Patent
Rights and/or Joint Patent Rights in the Territory for use in the Field shall be treated as
Other Shared Expenses.

ARTICLE XIII

INTELLECTUAL PROPERTY LITIGATION AND LICENSES

          13.1 Third Party Infringement Suits.

          (a) In the event that either Party or any of its Affiliates becomes aware of an
actual, potential or suspected infringement of a Sanofi Patent Right, a Regeneron Patent
Right, a Joint Patent Right, Product Trademark or any other intellectual property right
jointly owned or licensed under this Agreement, by a Third Party’s activities in the Field
in the Territory, the Party that became aware of the infringement shall promptly notify the
other Party in writing of this claim or assertion and shall provide such other Party with
all available evidence supporting such known, potential or suspected infringement or
unauthorized use. As soon as reasonably practicable after the receipt of such notice, the
Parties shall cause the JSC to meet and consider the appropriate course of action with
respect to such infringement. The Parties shall at all times cooperate, share all material
notices and filings in a timely manner, provide all reasonable assistance to each other and
use Commercially Reasonable Efforts to mutually agree upon an appropriate course of action,
including, as appropriate, the preparation of material court filings and any discussions
concerning prosecution and/or settlement of any such claim.

          (b) With respect to any such actual, suspected or potential infringement by virtue of
a generic or potential generic competitor’s activities in the Field in the Territory,
including but not limited to, any ANDA filing, Paragraph IV Certification (or the
equivalent for biologics) or other actual or potential infringement by a generic or
potential generic competitor anywhere in the Territory, the Parties will consult and
cooperate fully to determine a course of action. Final decisions on whether to initiate a
proceeding, and the course of action in such proceeding, including settlement negotiations
and terms, will be made by Sanofi with active assistance from and in consultation with
Regeneron. Regeneron will provide reasonable assistance to Sanofi in prosecuting any suit,
and if required by Law, will join in the suit. Although Sanofi has the right to select
counsel of its own choice, it shall first consult with Regeneron and consider in good faith
the recommendations of Regeneron. The amount of any recovery from any such infringement
suit with respect to activities in the Field in the Territory shall first be used to pay
reasonable costs, including attorneys’ fees, relating to such legal proceedings and then
shared equally by the Parties or according to the U.S. Profit Split and Rest of World
Profit Split if and as applicable.

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          (c) With respect to all other such actual, potential or suspected infringement by
virtue of a Third Party’s activities in the Field in the Territory, the Parties will
consult and cooperate fully in an effort to determine a mutually agreeable course of
action, provided if such agreement cannot be reached promptly, final decisions on whether
to initiate a proceeding, and the course of action in such proceeding, including settlement
negotiations and terms, will be
made (i) with respect to Regeneron Patent Rights, by Regeneron in consultation with
Sanofi, (ii) with respect to Sanofi Patent Rights, by Sanofi in consultation with
Regeneron, and (iii) with respect to Joint Patent Rights, jointly by the Parties. Any
disagreement between the Parties concerning the enforcement of Joint Patent Rights shall be
referred to the Executive Officers for resolution. The Party initiating the litigations
shall be referred to as the “Lead Litigation Party.” The non-Lead Litigation Party
will provide reasonable assistance to the Lead Litigation Party in prosecuting any suit,
and if required by Law, will join in the suit. Although the Lead Litigation Party has the
right to select counsel of its own choice, it shall first consult with the other Party and
consider in good faith the recommendations of the other Party. The amount of any recovery
from any such infringement suit with respect to activities in the Field in the Territory
shall first be used to pay reasonable costs, including attorneys’ fees, relating to such
legal proceedings and then shared equally by the Parties.

          (d) All Out-of-Pocket Costs incurred in connection with any litigation under Section
13.1(b) or (c) related to activities in the Field in the Territory shall be treated as
Other Shared Expenses.

          (e) For the avoidance of doubt, neither Party will enter into any settlement of any
suit referenced in this Section 13.1 that materially affects the other Party’s rights or
obligations with respect to the applicable Licensed Product in the Field in the Territory
without the other Party’s prior written consent. Furthermore, no Party shall enter into
any Third Party intellectual property license requiring the payment of royalties or other
amounts based on the Development, Manufacture or Commercialization of Licensed Products in
the Field in the Territory under this Agreement without the other Party’s prior written
consent.

          13.2 Patent Marking. Each Party shall comply with the patent marking statutes in each country
in which a Licensed Product in the Field is made, offered for sale, sold or imported by such Party,
its Affiliates and/or Sublicensees.

          13.3
Third Party Infringement Claims; New Licenses.

          (a) If either Party or its Affiliates shall learn of an allegation that the
Development, Manufacture or Commercialization of any Licensed Product in the Field in the
Territory under this Agreement infringes or otherwise violates the intellectual property
rights of any Third Party in the Territory, then such Party shall promptly notify the other
Party in writing of this allegation. As soon as reasonably practicable after the receipt
of such notice and at all times thereafter, the Parties shall meet and consider the
appropriate course of action with respect to such allegation of infringement. In any such
instance, each Party shall have the right to defend any action naming it using its own

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counsel; however, the Parties shall at all times cooperate, share all material notices and
filings in a timely manner, provide all reasonable assistance to each other and use
Commercially Reasonable Efforts to mutually agree upon an appropriate course of action,
including, as appropriate, the preparation of material court filings and
any discussions concerning a potential defense and/or settlement of any such claim.
The rights and obligations in this Section 13.3 shall apply even if only one Party defends
any claimed infringement action commenced by a Third Party in the Territory claiming that
the Development, Manufacture and/or Commercialization of any Licensed Product in the Field
under this Agreement infringes or otherwise violates any intellectual property rights of
any Third Party.

          (b) Except as otherwise set forth in this Agreement, all Out-of-Pocket Costs (except
for the expenses of the non-controlling Party’s counsel, if only one Party defends a claim)
incurred in connection with any litigation referred to in this Section 13.3 shall be
treated as Other Shared Expenses.

          (c) **************************.

          (d) License fees, royalties and other payments under Licenses to the extent
attributable to, and based on, the discovery, Development and Manufacture of Commercial
Supply Requirements or the Commercialization of Licensed Products in the Field in the
Territory shall be treated as Other Shared Expenses.

          (e) **************************************************.

ARTICLE XIV

BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS

          14.1
Books and Records. Each Party shall, and shall cause each of its respective Affiliates to,
keep proper books of record and account in which full, true and correct entries (in conformity with
GAAP or IAS/IFRS) shall be made for the purpose of determining the amounts payable or owed pursuant
to this Agreement. Each Party shall, and shall cause each of its respective Affiliates to, permit
auditors, as provided in Section 14.2, to visit and inspect, during regular business hours and
under the guidance of officers of the Party being inspected, and to examine the books of record and
account of such Party or such Affiliate to the extent relating to this Agreement and discuss the
affairs, finances and accounts of such Party or such Affiliate to the extent relating to this
Agreement with, and be advised as to the same by, its and their officers and independent
accountants.

          14.2
Audits and Adjustments.

          (a) Each Party shall have the right (at its own cost), upon no less than thirty (30)
days advance written notice and at such reasonable times and intervals and to such
reasonable extent as the investigating Party shall request, not more than once during

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any
Contract Year, to have the books and records of the other Party and its Affiliates to the
extent relating to this Agreement for the
preceding two (2) years audited by an independent “Big Four” (or equivalent)
accounting firm of its choosing under reasonable appropriate confidentiality provisions,
for the sole purpose of verifying the accuracy of all financial, accounting and numerical
information and calculations provided, and payments made, under this Agreement; provided
that no period may be subjected to audit more than one (1) time unless a material
discrepancy is found in any such audit of such period, in which case additional audits of
such period may be conducted until no material discrepancies are found.

          (b) The results of any such audit shall be delivered in writing to each Party and
shall be final and binding upon the Parties, unless disputed by a Party within ninety (90)
days. Unless otherwise mutually agreed by the Parties, any disputes regarding the results
of any such audit shall be subject to dispute resolution in accordance with Article X. If
the audited Party or its Affiliates have underpaid or over billed an amount due under this
Agreement resulting in a cumulative discrepancy during any year of more than seven and
one-half percent (7.5%), the audited Party shall also reimburse the other Party for the
costs of such audit (with the cost of the audit to be paid by the auditing party in all
other cases). Such accountants shall not reveal to the Party seeking verification the
details of its review, except for such information as is required to be disclosed under
this Agreement, and shall be subject to the confidentiality provisions contained in Article
XVI.

          (c) If any examination or audit of the records described above discloses an under- or
over-payment of amounts due hereunder, then unless the result of the audit is to be
contested pursuant to Section 14.2(b) above, the Party owing any money hereunder shall pay
the same (plus interest thereon at the Default Interest Rate from the date of such
underpayment through the date of payment of the amount required to be paid pursuant to this
Section 14.2(c)) to the Party entitled thereto within thirty (30) days after receipt of the
written results of such audit pursuant to this Section.

          14.3 GAAP/IAS/IFRS. Except as otherwise provided herein, all costs and expenses and other
financial determinations with respect to this Agreement shall be determined in accordance with, at
a Party’s election, GAAP or IAS/IFRS.

ARTICLE XV

REPRESENTATIONS, WARRANTIES AND COVENANTS

          15.1
Due Organization, Valid Existence and Due Authorization; Financial Capability. Each Party
hereby represents and warrants to the other Party, as of the Effective Date, as follows: (a) it is
duly organized and validly existing under the Laws of its jurisdiction of incorporation; (b) it has
full corporate (or, in the case of Sanofi Amerique, partnership) power and authority and has taken
all corporate (or, in the case of Sanofi Amerique, partnership) action necessary to enter into and
perform this Agreement; (c) the execution and performance by it of its obligations hereunder will
not constitute a breach of, or conflict with, its organizational documents nor any other agreement
by
which it is bound or any requirement of applicable Laws or regulations; (d) this Agreement is its
legal, valid and binding obligation, enforceable in

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accordance with the terms and conditions hereof
(subject to applicable Laws of bankruptcy and moratorium); (e) such Party is not prohibited by the
terms of any agreement to which it is a party from granting, the licenses granted to the other
under Article IV hereof; and (f) no broker, finder or investment banker is entitled to any
brokerage, finder’s or other fee in connection with this Agreement or the transactions contemplated
hereby based on arrangements made by it or on its behalf. Each Party hereby represents and
warrants to the other Party that such Party has, and will continue to have, sufficient liquid
assets to promptly and timely pay and perform all of the payments and obligations required by such
Party or its Affiliates to be paid and performed by them hereunder.

          15.2
Knowledge of Pending or Threatened Litigation. Each Party represents and warrants to the
other Party that, as of the Effective Date, there is no claim, announced investigation, suit,
action or proceeding pending or, to such Party’s knowledge, threatened, against such Party before
or by any Governmental Authority or arbitrator that, individually or in the aggregate, could
reasonably be expected to (a) materially impair the ability of such Party to perform any of its
obligations under this Agreement or (b) prevent or materially delay or alter the consummation of
any or all of the transactions contemplated hereby. During the Term, each Party shall promptly
notify the other Party in writing upon learning of any of the foregoing.

          15.3
Additional Regeneron Representations, Warranties and Covenants. Regeneron additionally
represents and warrants to Sanofi that, as of the Effective Date:

          (a) Regeneron owns all right, title and interest in and to all Regeneron Patent Rights
in existence as of the Effective Date;

          (b) Regeneron has the right and authority to grant the rights granted pursuant to the
terms and conditions of this Agreement and Regeneron has not granted any rights that would
be inconsistent with or in conflict with or in derogation of the rights granted herein;

          (c) there is no pending litigation that alleges that any of Regeneron’s activities
relating to the Regeneron Intellectual Property have violated, or would violate, the
intellectual property rights of any Third Party (nor has it received any written
communication threatening such litigation);

          (d) to Regeneron’s knowledge, no litigation has been otherwise threatened which
alleges that any of its activities relating to the Regeneron Intellectual Property have
violated or would violate, any intellectual property rights of any Third Party;

          (e) the conception, development and reduction to practice of any Regeneron
Intellectual Property existing as of the Effective Date has not constituted or involved the
misappropriation of trade secrets or other rights of any Person;

          (f) to Regeneron’s knowledge, the issued Patents included in the Regeneron
Intellectual Property existing as of the Effective Date are not invalid or unenforceable,
in whole or part;

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          (g) Regeneron has not received any written notice of any threatened claims or
litigation seeking to invalidate or otherwise challenge the Regeneron Patent Rights or
Regeneron’s rights therein, and, to Regeneron’s knowledge, none of the Regeneron Patent
Rights are subject to any pending re-examination, opposition, interference or litigation
proceedings; and

          (h) Regeneron has enforceable written agreements with all of its employees and
contractors who may participate in the conduct of the Collaboration or receive Confidential
Information hereunder assigning to Regeneron ownership of all intellectual property rights
created in the course of their employment or provision of services, as applicable.

          15.4 Disclaimer of Warranties. EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE,
CONCERNING THE SUCCESS OR POTENTIAL SUCCESS OF THE DEVELOPMENT, COMMERCIALIZATION, MARKETING OR
SALE OF ANY LICENSED PRODUCT IN THE FIELD. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY
EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE.

          15.5
Mutual Covenants. Each Party hereby covenants to the other Party as of the Effective Date
as follows: (a) it will not during the Term grant any right or license to any Third Party in the
Territory which would be inconsistent with or in conflict with or in derogation of the rights
granted to the other Party under this Agreement, and will not take any action that would materially
conflict with or adversely affect its obligations to the other Party under this Agreement; (b)
neither Party will use the Patent Rights or Know-How of the other Party outside the scope of the
licenses and rights granted to it under this Agreement; and (c) in the course of the Development or
Commercialization of a Licensed Product in the Field under this Agreement, it will not knowingly
use and will not have knowingly used an employee or consultant who is or has been debarred by a
Regulatory Authority or, to the best of such Party’s knowledge, is or has been the subject of
debarment proceedings by a Regulatory Authority.

ARTICLE XVI

CONFIDENTIALITY

          16.1 Confidential Information.

          (a) Each of Sanofi and Regeneron acknowledges (subject to the further provisions of
this Article XVI and the provisions of Article XIX) that
all Party Information provided to it (or its Affiliate) or otherwise made available to
it by the other Party or its respective Affiliates pursuant to this Agreement (or, in the
case of Sanofi, Party Information provided to it under the Confidentiality Agreements is
confidential and proprietary to such other Party. Furthermore, each of Sanofi and
Regeneron acknowledges (subject to the further provisions of this Article XVI) that all New

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Information is confidential and proprietary to both Parties. Subject to the further
provisions of this Article XVI, each of Sanofi and Regeneron agrees to (i) maintain such
Party Information of the other Party (or its Affiliates) and all New Information in
confidence during the Term and for a period of ten (10) years thereafter and (ii) use such
Party Information of the other Party (or its Affiliate) and New Information solely for the
purpose of exercising its rights and performing its obligations hereunder. Each of Sanofi
and Regeneron covenants that neither it nor any of its respective Affiliates shall disclose
any such Party Information of the other Party (or its Affiliate) or New Information to any
Third Party except (A) to its employees, agents, consultants or any other Person under its
authorization; provided such employees, agents, consultants or Persons are subject in
writing to substantially the same confidentiality obligations as the Parties, (B) as
approved by both Parties hereunder or (C) as set forth elsewhere in this Agreement.

          (b) Notwithstanding anything provided above, the restrictions provided in this Article
XVI shall not apply to information that was or is (and such information shall not be
considered confidential or proprietary under this Agreement) (i) already in the public
domain as of the Effective Date or becomes publicly known through no act, omission or fault
of the receiving Party or its Affiliate or any Person to whom the receiving Party or its
Affiliate provided such information; (ii) already in the possession of the receiving Party
or its Affiliate at the time of disclosure by the disclosing Party, other than under an
obligation of confidentiality; (iii) disclosed to the receiving Party or its Affiliate on
an unrestricted basis from a Third Party not under an obligation of confidentiality to the
other Party or any Affiliate of such other Party with respect to such information; (iv)
similar in nature to the purported Party Information or New Information but has been
independently created, as evidenced by written or electronic documentation, without any
aid, application or use of the Party Information or New Information; (v) necessary to file,
prosecute or defend Patents and Patent Applications for which the Party has the right to
assume filing, prosecution, defense or maintenance pursuant to this Agreement; or (vi)
required by a Governmental Authority, applicable Law (including the rules and regulations
of any stock exchange or trading market on which the disclosing Party’s (or its parent
entity’s) securities are traded), or court order to be disclosed, provided that the
receiving Party uses reasonable efforts to give the disclosing Party advance notice of such
required disclosure in sufficient time to enable the disclosing Party to seek confidential
treatment for such information or to request that the receiving Party seek confidential
treatment for such information, if applicable, and provided, further, that the receiving
Party provides all reasonable cooperation to assist the disclosing Party to protect such
information and limits the disclosure to that information which is required by Governmental
Authority, applicable Law
(including the rules or regulations of any stock exchange or trading market on which
the disclosing Party’s (or its parent entity’s) securities are traded) or court order to be
disclosed. Moreover, either Party may use Party Information and New Information to enforce
the terms of this Agreement if it gives reasonable advance notice to the other Party to
permit the other Party a sufficient opportunity to take any measures to ensure confidential
treatment of such information and the disclosing Party shall provide reasonable cooperation
to protect the confidentiality of such information.

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          (c) Notwithstanding anything provided above or elsewhere in this Agreement, Regeneron
and its Affiliates shall have the right to use and disclose any New Information directly
related to any Licensed Product (including the Manufacture or use thereof) to Governmental
Authorities or Regulatory Authorities as required by Law.

          (d) Notwithstanding anything provided above or elsewhere in this Agreement, Sanofi and
its Affiliates shall have the right to use and disclose any New Information directly
related to any Licensed Product (including the Manufacture or use thereof) to Governmental
Authorities or Regulatory Authorities as required by Law.

          16.2 Injunctive Relief. The Parties hereby acknowledge and agree that the rights of the Parties
hereunder are special, unique and of extraordinary character, and that if any Party refuses or
otherwise fails to act, or to cause its Affiliates to act, in accordance with the provisions of
this Agreement, such refusal or failure would result in irreparable injury to the other Party, the
exact amount of which would be difficult to ascertain or estimate and the remedies at law for which
would not be reasonable or adequate compensation. Accordingly, if any Party refuses or otherwise
fails to act, or to cause its Affiliates to act, in accordance with the provisions of this
Agreement, then, in addition to any other remedy which may be available to any damaged Party at law
or in equity, such damaged Party will be entitled to seek specific performance and injunctive
relief, without posting bond or other security, and without the necessity of proving actual or
threatened damages, which remedy such damaged party will be entitled to seek in any court of
competent jurisdiction.

          16.3 Publication of New Information. During the Term, if either Sanofi or Regeneron (the
“Publishing Party”) desires to disclose any New Information in scientific journals,
publications or scientific presentations, the Publishing Party shall provide the other Party an
advance copy of any proposed publication or summary of a proposed oral presentation relating to the
New Information prior to submission for publication or disclosure. Such other Party shall have a
reasonable opportunity to recommend any changes it reasonably believes are necessary to prevent any
specific, material adverse effect to it or the Licensed Product as a result of the publication or
disclosure (such recommendation of changes to include a description of the specific material
adverse effect) to which the Publishing Party shall give due consideration. Disputes concerning
publication shall be resolved by the JDC (other than Legal Disputes).

          16.4 Disclosures Concerning this Agreement. The Parties will mutually agree upon the contents
of their respective press releases with respect to the execution of this Agreement and any
Ancillary Agreement which shall be issued simultaneously by both Parties on the Effective Date.
Sanofi and Regeneron agree not to (and to ensure that their respective Affiliates do not ) issue
any other press releases or public announcements concerning this Agreement, any Ancillary Agreement
or any actions or activities contemplated hereunder or thereunder without the prior written consent
of the other Party (which shall not be unreasonably withheld or delayed), except as required by a
Governmental Authority or applicable Law (including the rules and regulations of any stock exchange
or trading market on which a Party’s (or its parent entity’s) securities are traded); provided that
the Party intending to disclose such information shall use reasonable efforts to provide the other
Party advance notice of such required disclosure, an opportunity to review and comment on such
proposed disclosure (which comments shall be considered in good faith by the disclosing Party) and
all reasonable

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cooperation to assist the other Party to protect such information and shall limit
the disclosure to that information which is required to be disclosed. Notwithstanding the
foregoing, without prior submission to or approval of the other Party, either Party may issue press
releases or public announcements which incorporate information concerning this Agreement, any
Ancillary Agreement or any actions or activities contemplated hereunder or thereunder which
information was included in a press release or public disclosure which was previously disclosed
under the terms of this Agreement or which contains only non-material factual information regarding
the Collaboration. Except as required by a Governmental Authority or applicable Law (including the
rules and regulations of any stock exchange or trading market on which a Party’s (or its parent
entity’s) securities are traded), or in connection with the enforcement of this Agreement, neither
Party (or their respective Affiliates) shall disclose to any Third Party, under any circumstances,
any financial terms of this Agreement that have not been previously disclosed publicly pursuant to
this Article XVI without the prior written consent of the other Party, which consent shall not be
unreasonably withheld or delayed; except for disclosures to Third Parties that are bound by
obligations of confidentiality and nonuse substantially equivalent in scope to those included
herein with a term of at least five (5) years. The Parties, through the Committees, shall establish
mechanisms and procedures to ensure that there are coordinated timely corporate communications
relating to the Licensed Products in the Field. Sanofi acknowledges that Regeneron as a publicly
traded company may be legally obligated to make timely disclosures of material events relating to
Licensed Products. The Parties acknowledge that either or both Parties may be obligated to file a
copy of this Agreement and each Ancillary Agreement with the United States Securities and Exchange
Commission or its equivalent in the Territory. Each Party will be entitled to make such filing but
shall use reasonable efforts to obtain confidential treatment of confidential, including trade
secret, information in accordance with applicable Law. The filing Party will provide the
non-filing Party with an advance copy of the Agreement marked to show provisions for which the
filing Party intends to seek confidential treatment and will reasonably consider the non-filing
Party’s timely comments thereon.

ARTICLE XVII

INDEMNITY

          17.1 Indemnity and Insurance.

          (a) Sanofi will defend, indemnify and hold harmless Regeneron, its Affiliates and
their respective officers, directors, employees, licensees and agents (“Regeneron
Indemnitees”) from and against all claims, demands, liabilities, damages, penalties,
fines, costs and expenses, including reasonable attorneys’ and expert fees and costs, and
costs or amounts paid to settle (collectively, “Damages”), arising from or
occurring as a result of a Third Party’s claim, action, suit, judgment or settlement
against a Regeneron Indemnitee that is due to or based upon:

          (i) the gross negligence, recklessness, bad faith, intentional wrongful acts
or omissions or violations of Law by or of Sanofi, its Affiliates or their
respective directors, officers, employees, agents or Sublicensees, including,
without limitation, in connection with the Development, Manufacture or
Commercialization of any Licensed Product in the Field, except to the extent that
Damages arise out of, and are allocable to, the gross negligence, recklessness, bad

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faith, intentional wrongful acts or omissions or violations of Law committed by
Regeneron or any other Regeneron Indemnitee; or

          (ii) material breach by Sanofi of the terms of, or the inaccuracy when made of
any representation or warranty made by it in, this Agreement.

          (b) Regeneron will defend, indemnify and hold harmless Sanofi, its Affiliates and
their respective officers, directors, employees, Sublicensees and agents (“Sanofi
Indemnitees”) from and against all Damages arising from or occurring as a result of a
Third Party’s claim, action, suit, judgment or settlement against a Sanofi Indemnitee that
is due to or based upon:

          (i) the gross negligence, recklessness, bad faith, intentional wrongful acts
or omissions or violations of Law by or of Regeneron, its Affiliates or their
respective directors, officers, employees, licensees or agents including, without
limitation, in connection with the Development, Manufacture or Commercialization of
any Licensed Product in the Field, except to the extent that Damages arise out of,
and are allocable to, the gross negligence, recklessness, bad faith, intentional
wrongful acts, or omissions or violations of Law committed by Sanofi or any other
Sanofi Indemnitee; or

          (ii) material breach by Regeneron of the terms of, or the inaccuracy when made
of any representation or warranty made by it in, this Agreement.

          (c) In the event of any Third Party claim alleging that the Development, Manufacture
and/or Commercialization of any Licensed Product in the Field under this Agreement
infringes a Patent Right of a Third Party for which neither Party is entitled to
indemnification hereunder, each Party shall indemnify the other Party for fifty percent
(50%) of all Damages therefrom and during the Term such Damages shall be treated as Other
Shared Expenses.

          (d) In the event of any Third Party product liability claim alleging that the
Development or Commercialization of any Licensed Product in the Field causes damages for
which neither Party is entitled to indemnification hereunder, each Party shall indemnify
the other for fifty percent (50%) of all Damages therefrom and during the Term such Damages
shall be treated as Other Shared Expenses.

          (e) Each of Regeneron and Sanofi will use Commercially Reasonable Efforts to procure
and maintain during the Term and for a minimum period of five (5) years thereafter and for
an otherwise longer period as may be required by applicable Law in countries where the
project is conducted, product liability insurance in an amount not less than
**************** in the annual aggregate. Such insurance shall insure against liability on
the part of Regeneron and Sanofi and any of its Affiliates, due to injury, disability or
death of any person or persons, or property damage arising from services performed under
this Agreement.

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          (f) Notwithstanding anything to the contrary in this Section 17.1, neither Party shall
be responsible to indemnify the other Party (or the Regeneron Indemnitees or Sanofi
Indemnitees, as the case may be) from Third Party claims resulting from, and to the extent
allocable to, the negligence, recklessness, bad faith, intentional wrongful acts or
omissions, or violations of Law committed by Third Parties contracted to Manufacture any
part of the Clinical Supply Requirements or Commercial Supply Requirements pursuant to
Article VIII; provided, however, that nothing in this Section 17.1(f) limits either Party’s
indemnification obligations to the extent any Third Party claims arise from the negligence,
recklessness, bad faith, intentional wrongful acts or omissions, or violations of Law
committed directly by the Party that is responsible for contracting with such Third Party
Manufacturer(s) pursuant to Article VIII.

          17.2 Indemnity Procedure. The Party entitled to indemnification under this Article XVII (an
“Indemnified Party”) shall notify the Party potentially responsible for such
indemnification (the “Indemnifying Party”) within five (5) Business Days of becoming aware
of any claim or claims asserted or threatened against the Indemnified Party which could give rise
to a right of indemnification under this Agreement; provided, however, that the failure to give
such notice shall not relieve the Indemnifying Party of its indemnity obligation hereunder except
to the extent that such failure materially prejudices its rights hereunder. For the avoidance of
doubt, the indemnification procedures in this Section 17.2 shall not apply to claims for which each
Party indemnifies the other Party for fifty percent (50%) of all Damages, under the terms of
Section 17.1(c).

          (a) If the Indemnifying Party has acknowledged in writing to the Indemnified Party the
Indemnifying Party’s responsibility for defending such claim, the Indemnifying Party shall
have the right to defend, at its sole cost and expense, such claim by all appropriate
proceedings, which proceedings shall be prosecuted diligently by the Indemnifying Party to
a final conclusion or settled at the discretion of the Indemnifying Party; provided,
however, that the Indemnifying Party may not enter into any compromise or settlement unless
(i) such compromise or settlement includes as an unconditional term thereof, the giving by
each claimant or plaintiff to the Indemnified Party of a release from all liability in
respect of such claim; and (ii) such compromise or settlement does not (A) include any
admission of legal wrongdoing by the Indemnified Party, (B) require any payment by the
Indemnified Party that is not indemnified hereunder or (C) result in the imposition of any
equitable relief against the Indemnified Party. If the Indemnifying Party does not elect
to assume control of the defense of a claim or if a good faith and diligent defense is not
being or ceases to be materially conducted by the Indemnifying Party, the Indemnified Party
shall have the right, at the expense of the Indemnifying Party, upon ten (10) Business
Days’ prior written notice to the Indemnifying Party of its intent to do so, to undertake
the defense of such claim for the account of the Indemnifying Party (with counsel
reasonably selected by the Indemnified Party and approved by the Indemnifying Party, such
approval not unreasonably withheld or delayed); provided that the Indemnified Party shall
keep the Indemnifying Party apprised of all material developments with respect to such
claim and promptly provide the Indemnifying Party with copies of all correspondence and
documents exchanged by the Indemnified Party and the opposing party(ies) to such

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litigation. The Indemnified Party may not compromise or settle such litigation without the
prior written consent of the Indemnifying Party, such consent not to be unreasonably
withheld or delayed.

          (b) The Indemnified Party may participate in, but not control, any defense or
settlement of any claim controlled by the Indemnifying Party pursuant to this Section 17.2
and shall bear its own costs and expenses with respect to such participation; provided,
however, that the Indemnifying Party shall bear such costs and expenses if counsel for the
Indemnifying Party shall have reasonably determined that such counsel may not properly
represent both the Indemnifying Party and the Indemnified Party.

          (c) The amount of any Damages for which indemnification is provided under this Article
XVII will be reduced by the insurance proceeds received, and any other amount recovered if
any, by the Indemnified Party in respect of any such Damages.

          (d) If an Indemnified Party receives an indemnification payment pursuant to this
Article XVII and subsequently receives insurance proceeds from its insurer with respect to
the Damages in respect of which such indemnification payment(s) was made, the Indemnified
Party will promptly pay to the Indemnifying Party an amount equal to the difference (if
any) between (i) the
sum of such insurance proceeds or other amounts received, and the indemnification
payment(s) received from the Indemnifying Party pursuant to this Article XVII and (ii) the
amount necessary to fully and completely indemnify and hold harmless the Indemnified Party
from and against such Damages. However, in no event will such refund ever exceed the
Indemnifying Party’s indemnification payment(s) to the Indemnified Party under this Article
XVII.

ARTICLE XVIII

FORCE MAJEURE

     Neither Party will be held liable or responsible to the other Party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from causes beyond the
reasonable control of the affected Party including, without limitation, embargoes, acts of
terrorism, acts of war (whether war be declared or not), insurrections, strikes, riots, civil
commotions or acts of God (“Force Majeure”). Such excuse from liability and responsibility
shall be effective only to the extent and duration of the event(s) causing the failure or delay in
performance and provided that the affected Party has not caused such event(s) to occur. The
affected Party will notify the other Party of such Force Majeure circumstances as soon as
reasonably practical and will make every reasonable effort to mitigate the effects of such Force
Majeure circumstances.

ARTICLE XIX

TERM AND TERMINATION

          19.1 Term/Expiration of Term.

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          (a) The “Term” of this Agreement shall commence on the Effective Date and,
unless this Agreement is earlier terminated in its entirety in accordance with this Article
XIX, shall expire upon the later to occur of (i) the expiration of the Discovery Program,
and (ii) such time as neither Party, nor either Party’s Affiliates or Sublicensees, is
Developing or Commercializing any Licensed Product in the Field in the Territory under this
Agreement and such cessation of Development and Commercialization activities is
acknowledged by both Parties in writing to be permanent.

          (b) Upon expiration of the Term pursuant to Section 19.1(a) above, except as set forth
in this Agreement, all licenses and rights with respect to Licensed Products shall
automatically terminate and revert to the granting Party.

          19.2 Termination Without Cause.

          (a) By Sanofi. (i) Sanofi may terminate this Agreement in its entirety, but
only after the expiration or earlier termination of the Discovery Program in accordance
with the terms of the Discovery Agreement, or may terminate this Agreement in the entire
Territory for a particular Licensed Product or particular Licensed Products in the Field,
in any such case on twelve (12) months’ prior written notice to Regeneron. Except as
otherwise provided below in
this Section 19.2(a), in the event of such termination by Sanofi of this Agreement in
its entirety or with respect to one or more Licensed Product(s) pursuant to this Section
19.2, this Agreement (including, without limitation, all payment obligations hereunder)
shall continue in full force and effect through the notice period set forth above (the
“Sanofi Termination Notice Period”) and the terms of Schedule 4 (including the
grant of rights and licenses set forth in paragraph 2 thereof) shall automatically apply.
Except as set forth in this Section 19.2(a) or Schedule 4, during the Sanofi Termination
Notice Period, the Parties shall continue to Develop, Manufacture and Commercialize
Licensed Products (including the Opt-Out Products(s)) in the Field in accordance with
Plans. During the Sanofi Termination Notice Period, to the extent set forth or requested in
one or more written notices from Regeneron to Sanofi hereunder and in any event upon the
expiration of the Sanofi Termination Notice Period, whether or not any such notice is given
by Regeneron, (i) the licenses and rights granted by Regeneron to Sanofi hereunder with
respect to the Opt-Out Product(s) shall automatically terminate as of a date specified in
such notice(s) (and in any event not later than the expiration of the Sanofi Termination
Notice Period), (ii) the licenses and rights granted by Sanofi to Regeneron hereunder with
respect to the Opt-Out Product(s) shall terminate, and (iii) Sanofi will promptly take the
actions required by Schedule 4 and Regeneron will reasonably cooperate with Sanofi (for
avoidance of doubt, such cooperation shall not require Regeneron to pay any amounts or
incur any liabilities or obligations not otherwise required hereunder to be paid or
incurred by Regeneron) to facilitate Regeneron’s (or its nominee’s) expeditious assumption
during the Sanofi Termination Notice Period and thereafter, with as little disruption as
reasonably possible, of the continued Development, Manufacture and Commercialization of the
Opt-Out Product(s) in the Field in the Territory. In addition, during the Sanofi
Termination Notice Period, neither Party will, without the prior written consent of the
other Party’s representatives on the applicable Committee, propose or implement any
amendment or

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change to any Plan. Notwithstanding the foregoing, the Committee(s) will have
an obligation under this Agreement and the Collaboration Purpose to propose and adopt in a
timely manner an interim Plan for any Plan that expires during the Sanofi Termination
Notice Period. The most recent approved Plan(s) shall be extended pending approval of the
new interim Plan(s).

          (ii) In addition to Sanofi’s termination rights set forth in Section
19.2(a)(i), from and after the twelfth (12th) anniversary of the First
Commercial Sale of a Licensed Product in a country, Sanofi may, upon twenty-four
(24) months’ prior written notice to Regeneron, terminate this Agreement with
respect to such Licensed Product in such country. If Sanofi exercises such right,
the provisions of Section 19.2(a)(i) (except that the Sanofi Termination Notice
Period referred to therein shall be twenty-four (24) months rather than twelve (12)
months), and Sections 19.7(a) and 19.8 shall apply with respect to such Terminated
Licensed Product in such country.

          (b) By Regeneron. Regeneron may terminate this Agreement in its entirety, but
only after the expiration or earlier termination of the Discovery Program in accordance
with its terms, or may terminate this Agreement in the entire Territory for a particular
Licensed Product or particular Licensed Products in the Field, in any such case, on twelve
(12) months’ prior written notice to Sanofi. Except as otherwise provided below in this
Section 19.2(b), in the event of such termination by Regeneron of this Agreement in its
entirety or with respect to one or more Licensed Product(s) pursuant to this Section
19.2(b), this Agreement (including, without limitation, all payment obligations hereunder)
shall continue in full force and effect through the notice period set forth above (the
“Regeneron Termination Notice Period”) and the terms of Schedule 5 (including the
grant of rights and licenses set forth in paragraph 2 thereof) shall automatically apply.
Except as set forth in this Section 19.2(b) or Schedule 5, during the Regeneron Termination
Notice Period, the Parties shall continue to Develop, Manufacture and Commercialize
Licensed Products (including the Opt-Out Products(s)) in the Field in accordance with
Plans. During the Regeneron Termination Notice Period, to the extent set forth or requested
in one or more written notices from Sanofi to Regeneron hereunder and in any event upon the
expiration of the Regeneron Termination Notice Period, whether or not any such notice is
given by Sanofi, (i) the licenses and rights granted by Sanofi to Regeneron hereunder with
respect to the Opt-Out Product(s) shall automatically terminate as of a date specified in
such notice(s) (and in any event not later than the expiration of the Regeneron Termination
Notice Period), (ii) the licenses and rights granted by Regeneron to Sanofi hereunder with
respect to the Opt-Out Products(s) shall terminate, and (iii) Regeneron will promptly take
the actions required by Schedule 5 and Sanofi will reasonably cooperate with Regeneron (for
avoidance of doubt, such cooperation shall not require Sanofi to pay any amounts or incur
any liabilities or obligations not otherwise required hereunder to be paid or incurred by
Sanofi) to facilitate Sanofi’s (or its nominee’s) expeditious assumption during the
Regeneron Termination Notice Period and thereafter, with as little disruption as reasonably
possible, of the continued Development, Manufacture and Commercialization of the Opt-Out
Product(s) in the Field in the Territory. In addition, during the Regeneron Termination

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Notice Period, neither Party will, without the prior written consent of the other Party’s
representatives on the applicable Committee, propose or implement any amendment or change
to any Plan. Notwithstanding the foregoing, the Committee(s) will have an obligation under
this Agreement and the Collaboration Purpose to propose and adopt in a timely manner an
interim Plan for any Plan that expires during the Regeneron Termination Notice Period. The
most recent approved Plan(s) shall be extended pending approval of the new interim Plan(s).

          19.3 Termination For Material Breach. Upon and subject to the terms and conditions of this
Section 19.3, this Agreement shall be terminable by a Party in its entirety or for a particular
Licensed Product or particular Licensed Products in the Field in the entire Territory, upon written
notice to the other Party, if such other Party commits a material breach of its obligations under
this Agreement with respect to such Licensed Product(s) as to which such notice of termination is
given (or all Licensed Products if
such notice of termination is with respect to this Agreement is in its entirety). Such notice of
termination shall set forth in reasonable detail the facts underlying or constituting the alleged
breach (and specifically referencing the provisions of this Agreement alleged to have been
breached), and the termination which is the subject of such notice shall be effective ninety (90)
days after the date such notice is given unless the breaching Party shall have cured such breach
within such ninety (90) day period (or, if such material breach, by its nature, is a curable breach
but such breach is not curable within such ninety (90) day period, such longer period not to exceed
one hundred eighty (180) days so long as the breaching party is using Commercially Reasonable
Efforts to cure such breach, in which event if such breach has not been cured, such termination
shall be effective on the earlier of the expiration of such one hundred eighty (180) day period or
such time as the breaching party ceases to use Commercially Reasonable Efforts to cure such
breach). Notwithstanding the foregoing, in the case of breach of a payment obligation hereunder,
the ninety (90) day period referred to in the immediately preceding sentence shall instead be
thirty (30) days (and the immediately preceding parenthetical clause in the immediately preceding
sentence shall not apply). For purposes of this Section 19.3, the term “material breach” shall
mean an intentional, continuing (and uncured within the time period described above) material
breach by a Party, as determined by a court of competent jurisdiction.

          19.4
Termination for Insolvency. Either Party shall have the right to terminate this Agreement
in its entirety, by and effective immediately, upon written notice to the other Party, if, at any
time, (a) the other Party shall file in any court or agency pursuant to any statute or regulation
of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of the Party or of its assets, (b) if
the other Party shall be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed or stayed within ninety (90) days after the
filing thereof or (c) if the other Party shall make a general assignment for the benefit of
creditors. In the event that this Agreement is terminated or rejected by a Party or its receiver
or trustee under applicable bankruptcy Laws due to such Party’s bankruptcy, then all rights and
licenses granted under or pursuant to this Agreement by such Party to the other Party are, and
shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and any
similar Laws in any other country in the Territory, licenses of rights to “intellectual property”
as defined under Section 101(35A) of the U.S. Bankruptcy Code. The Parties agree

78

 

that all
intellectual property rights licensed hereunder, including, without limitation, any patents or
patent applications in any country of a party covered by the license grants under this Agreement,
are part of the “intellectual property” as defined under Section 101(52) of the Bankruptcy Code
subject to the protections afforded the non-terminating Party under Section 365(n) of the
Bankruptcy Code, and any similar law or regulation in any other country.

          19.5 Termination for Breach of Standstill or Lock-Up. Regeneron shall have the unilateral right
to terminate this Agreement in its entirety, effective immediately upon written notice to Sanofi,
if Sanofi or any of its Affiliates shall have breached their obligations under any of Sections 3, 4
or 5 of the Investor Agreement (to the extent such sections of the Investor Agreement is then in
effect). Furthermore, Regeneron shall have
the unilateral right to terminate this Agreement in its entirety, effective immediately upon
written notice to Sanofi, if Sanofi or any of its Affiliates shall have (a) breached their
obligations under Section 20.16 of the Aventis Collaboration Agreement, to the extent that such
Section 20.16 remains in effect after the Effective Date, or (b) breached its obligations under
Section 5.3 of the Aventis Stock Purchase Agreement, to the extent that such Section 5.3 remains in
effect after the Effective Date. Any such breach of the Investor Agreement, the Aventis Stock
Purchase Agreement or the Aventis Collaboration Agreement, as the case may be, shall be treated as
a breach of this Agreement. Notwithstanding the foregoing and for the avoidance of doubt,
Regeneron shall not have the right to terminate this Agreement as a result of (i) a de minimus
breach of Section 3.1(a) of the Investor Agreement (to the extent such Section 3.1(a) is in effect
after the Effective Date) or of Section 20.16(a) of the Aventis Collaboration Agreement (to the
extent such Section 20.16(a) remains in effect after the Effective Date) or (ii) an inadvertent
breach of Section 3.1(g) of the Investor Agreement (to the extent such Section 3.1(g) is in effect
after the Effective Date) or an inadvertent breach of Section 20.16(g) of the Aventis Collaboration
Agreement (to the extent such Section 20.16(g) remains in effect after the Effective Date), arising
from informal discussions covering general corporate or other business matters the purpose of which
is not intended to effectuate or lead to any of the actions referred to in paragraphs (a) through
(e) of such Section 20.16 or of paragraphs (a) through (e) of Section 3.1 of the Investor
Agreement, as applicable.

          19.6 Termination of Discovery Agreement.

          (a) By Regeneron. Regeneron may terminate this Agreement in its entirety,
effective upon written notice to Sanofi, if the Discovery Agreement has been terminated by
Regeneron pursuant to Section 12.2, 12.3 or 12.5 thereof.

          (b) By Sanofi. Sanofi may terminate this Agreement in its entirety effective
upon written notice to Regeneron, if the Discovery Agreement has been terminated by Sanofi
pursuant to Section 12.2 or 12.3 thereof.

          (c) Automatic. This Agreement shall automatically terminate in its entirety
if, at the time the Discovery Agreement terminates for any reason pursuant to Article 12
thereof, Sanofi has not exercised its Opt-In Right pursuant to Section 5.3 of the Discovery
Agreement with respect to any Product Candidate.

          19.7
Effect of Termination.

79

 

          (a) Except as provided in Section 19.2(b), and in Section 19.7(b) below, upon
termination of this Agreement with respect to all Licensed Products in the Field, or for a
particular Licensed Product or particular Licensed Products in the Field in the Territory
or, if applicable pursuant to Section 19.2(a)(ii), in one or more countries, the provisions
of Schedule 4 shall apply (including during any applicable Termination Notice Period) with
respect to the Terminated Licensed Product(s), and except to the extent required by Sanofi
to fulfill its obligations pursuant to Schedule 4, (i) all licenses and rights granted by
Regeneron to Sanofi hereunder with respect to the Terminated Licensed Product(s) shall
automatically terminate, and revert to Regeneron, (ii) all licenses and rights granted by
Sanofi to Regeneron hereunder with respect to the Terminated Licensed Product(s) shall
automatically terminate and (iii) the license from Sanofi and its Affiliates to Regeneron
referred to in Schedule 4 shall automatically come into full force and effect with respect
to the Terminated Licensed Product(s). If Regeneron terminates this Agreement pursuant to
Section 19.3, 19.4 or 19.5, or pursuant to Section 19.6(a) then Sanofi shall pay to
Regeneron, in addition to any other amount payable by Sanofi to Regeneron under this
Agreement, under Law, or pursuant to any contractual remedies available to Regeneron, an
amount equal to one hundred percent (100%) of the Development Costs incurred by Regeneron
under the Global Development Plan during the period commencing on the effective date of
such termination of this Agreement pursuant to any of such Sections and ending on the
twelve (12) month anniversary of such date.

          (b) Upon termination of this Agreement by Regeneron pursuant to Section 19.2(b) or by
Sanofi pursuant to Section 19.3 or 19.4, in its entirety, or for a particular Licensed
Product or particular Licensed Products in the Field, the provisions of Schedule 5 shall
apply (including during any applicable Termination Notice Period) with respect to the
Terminated Licensed Product(s) and, except to the extent required by Regeneron to fulfill
its obligations pursuant to Schedule 5, (i) all licenses and rights granted by Sanofi to
Regeneron hereunder with respect to the Terminated Licensed Product(s) shall automatically
terminate, and revert to Sanofi, (ii) all licenses and rights granted by Regeneron to
Sanofi hereunder with respect to the Terminated Licensed Product(s) shall automatically
terminate and (iii) the license from Regeneron referred to in Schedule 5 shall come into
full force and effect with respect to the Terminated Licensed Product(s)

          19.8 Survival of Obligations. Except as otherwise provided in this Article XIX, or Schedule 4
or Schedule 5, upon expiration, or upon termination of this Agreement with respect to all Licensed
Products in the Field, or for a particular Licensed Product or particular Licensed Products in the
Field in the Territory or, if applicable pursuant to Section 19.2(a)(ii), in one or more countries,
the rights and obligations of the Parties hereunder with respect to the Terminated Licensed
Product(s), in the applicable country or countries if such termination is pursuant to Section
19.2(a)(ii), shall terminate, and this Agreement shall cease to be of further force or effect to
the extent of such termination, provided that notwithstanding any expiration or termination of this
Agreement:

80

 

          (a) neither Sanofi nor Regeneron shall be relieved of any obligations (including
payment obligations) of such Party arising prior to such expiration or termination,
including, without limitation, the payment of any non-cancelable costs and expenses incurred
as part of a Plan (even if such costs and expenses arise following termination or
expiration, as the case may be), except that Regeneron’s obligations with respect to the
Global Development Balance payments provided for in Schedule 2 shall automatically terminate
and the Global Development Balance shall equal zero;

          (b) subject to the provisions of this Article XIX, including Schedule 4 and Schedule 5
to the extent applicable, the obligations of the Parties with respect to the protection and
nondisclosure of Party Information and New Information in accordance with Article XVI, as
well as other provisions (including, without limitation, Sections 7.4, 9.8, 9.9, 9.12, 10.3
and 10.4, the second sentence of Section 12.1(e) and Articles XII (with respect to Joint
Inventions), XVI, XVII, XIX and XX) which by their nature are intended to survive any such
expiration or termination, shall survive and continue to be enforceable; and

          (c) such expiration or termination and this Article XIX shall be without prejudice to
any rights or remedies a party may have for breach of this Agreement.

ARTICLE XX

MISCELLANEOUS

          20.1 Governing Law; Submission to Jurisdiction. This Agreement shall be governed by and
construed in accordance with the Laws of the State of New York, without regard to the conflict of
laws principles thereof that would require the application of the Law of any other jurisdiction.
Except as set forth in Article X, the Parties irrevocably and unconditionally submit to the
exclusive jurisdiction of the United States District Court for the Southern District of New York
solely and specifically for the purposes of any action or proceeding arising out of or in
connection with this Agreement.

          20.2 Waiver. Waiver by a Party of a breach hereunder by the other Party shall not be
construed as a waiver of any subsequent breach of the same or any other provision. No delay or
omission by a Party in exercising or availing itself of any right, power or privilege hereunder
shall preclude the later exercise of any such right, power or privilege by such Party. No waiver
shall be effective unless made in writing with specific reference to the relevant provision(s) of
this Agreement and signed by a duly authorized representative of the Party granting the waiver.

          20.3 Notices. All notices, instructions and other communications required or permitted
hereunder or in connection herewith shall be in writing, shall be sent to the address of the
relevant Party set forth on Schedule 6 attached hereto and shall be (a) delivered personally, (b)
sent via a reputable

81

 

nationwide overnight courier service, or (c) sent by facsimile transmission, with a confirmation
copy to be sent by registered or certified mail, return receipt requested, postage prepaid. Any
such notice, instruction or communication shall be deemed to have been delivered upon receipt if
delivered by hand, one (2) Business Days after it is sent via a reputable nationwide overnight
courier service or when transmitted with electronic confirmation of receipt, if transmitted by
facsimile (if such transmission is made during regular business hours of the recipient on a
Business Day; or otherwise, on the next Business Day following such transmission). Either Party
may change its address by giving notice to the other Party in the manner provided above.

          20.4 Entire Agreement. This Agreement, together with the Discovery Agreement and, solely to
the extent referred to herein, the Ancillary Agreements contain the complete understanding of the
Parties with respect to the subject matter hereof and thereof and supersedes all prior
understandings and writings relating to the subject matter hereof and thereof, provided that the
last sentence of Section 1.41 of the Discovery Agreement shall apply with respect to any conflict
or inconsistency between this Agreement and the Discovery Agreement.

          20.5 Amendments. No provision in this Agreement shall be supplemented, deleted or amended
except in a writing executed by an authorized representative of each of Sanofi and Regeneron.

          20.6 Interpretation. The captions to the several Articles and Sections of this Agreement
are included only for convenience of reference and shall not in any way affect the construction of,
or be taken into consideration in interpreting, this Agreement. In this Agreement: (a) the word
“including” shall be deemed to be followed by the phrase “without limitation” or like expression;
(b) references to the singular shall include the plural and vice versa; (c) references to
masculine, feminine and neuter pronouns and expressions shall be interchangeable; and (d) the words
“herein” or “hereunder” relate to this Agreement.

          20.7 Severability. If, under applicable Laws, any provision hereof is invalid or
unenforceable, or otherwise directly or indirectly affects the validity of any other material
provision(s) of this Agreement in any jurisdiction (“Modified Clause”), then, it is
mutually agreed that this Agreement shall endure and that the Modified Clause shall be enforced in
such jurisdiction to the maximum extent permitted under applicable Laws in such jurisdiction;
provided that the Parties shall consult and use all reasonable efforts to agree upon, and hereby
consent to, any valid and enforceable modification of this Agreement as may be necessary to avoid
any unjust enrichment of either Party and to match the intent of this Agreement as closely as
possible, including the economic benefits and rights contemplated herein.

          20.8 Registration and Filing of the Agreement. To the extent that a Party concludes in good faith that
it is or may be required to file or
register this Agreement or a notification thereof with any Governmental Authority in accordance
with applicable Laws, such Party may do so subject to the provisions of Section 16.4. The other
Party shall promptly cooperate in such filing or notification and shall promptly execute all
documents reasonably required in connection therewith. The Parties shall promptly inform each
other as to the activities or inquiries of any such Governmental Authority relating to this
Agreement, and shall promptly cooperate to respond to any request for further information
therefrom.

          20.9 Assignment. Except as otherwise expressly provided herein, neither this Agreement nor
any of the rights or obligations hereunder may be assigned by either Sanofi or Regeneron without
(a) the prior written consent of Regeneron in the case of any assignment by

82

 

Sanofi or (b) the prior
written consent of Sanofi in the case of an assignment by Regeneron, except in each case (i) to an
Affiliate of the assigning Party that has and will continue to have the resources and financial
wherewithal to fully meet its obligations under this Agreement, provided that the assigning Party
shall remain primarily liable hereunder notwithstanding any such assignment, or (ii) to any other
party who acquires all or substantially all of the business of the assigning Party by merger, sale
of assets or otherwise, so long as such Affiliate or other party agrees in writing to be bound by
the terms of this Agreement. The assigning Party shall remain primarily liable hereunder
notwithstanding any such assignment. Any attempted assignment in violation hereof shall be void.

          20.10 Successors and Assigns. This Agreement shall be binding upon and inure to the benefit
of the Parties hereto and their respective successors and permitted assigns, and shall also inure
to the benefit of the Regeneron Indemnitees and Sanofi Indemnitees to the extent provided in the
last sentence of Section 20.13.

          20.11 Affiliates. Each Party may, and to the extent it is in the best interests of the
Licensed Products in the Field in the Territory shall, perform its obligations hereunder through
one or more of its Affiliates. Each Party absolutely, unconditionally and irrevocably guarantees
to the other Party the prompt and timely performance when due and at all times thereafter of the
responsibilities, liabilities, covenants, warranties, agreements and undertakings of its Affiliates
pursuant to this Agreement. Sanofi Amerique guarantees to Regeneron the prompt and timely payment
of amounts payable by Sanofi to Regeneron hereunder once those amounts have become legally due and
payable. Without limiting the foregoing, no Party shall cause or permit any of its Affiliates to
commit any act (including any act or omission) which such Party is prohibited hereunder from
committing directly. If an Affiliate of a Party will engage in the Development, Manufacture or
Commercialization of a Licensed Product under this Agreement, then such Party shall enter into a
separate agreement with such Affiliate pursuant to which the obligations of such Party hereunder
shall be binding on such Affiliate and which shall provide that the other Party is a third-party
beneficiary of such agreement entitled to enforce such agreement and this Agreement against such
Affiliate. Each Party represents and warrants to the other Party that it has licensed
or will license from its Affiliates the Patents and Know-How owned by its Affiliates that are to be
licensed (or sublicensed) to the other Party under this Agreement.

          20.12 Counterparts. This Agreement may be executed in counterparts, each of which shall be
deemed an original but which together shall constitute one and the same instrument.

          20.13 Third-Party Beneficiaries. None of the provisions of this Agreement shall be for the
benefit of or enforceable by any Third Party, including any creditor of any Party hereto. No Third
Party shall obtain any right under any provision of this Agreement or shall by reason of any such
provision make any claim in respect of any debt, liability or obligation (or otherwise) against any
Party hereto. Notwithstanding the foregoing, Article XVII is intended to benefit, in addition to
the Parties, the other Regeneron Indemnitees and Sanofi Indemnitees as if they were parties hereto,
but this Agreement is enforceable only by the Parties.

83

 

          20.14 Relationship of the Parties. Each Party shall bear its own costs incurred in the
performance of its obligations hereunder without charge or expense to the other Party except as
provided for in this Agreement. Neither Sanofi nor Regeneron shall have any responsibility for the
hiring, termination or compensation of the other Party’s employees or for any employee compensation
or benefits of the other Party’s employees. No employee or representative of a Party shall have
any authority to bind or obligate the other Party to this Agreement for any sum or in any manner
whatsoever, or to create or impose any contractual or other liability on the other Party without
said Party’s approval. For all purposes, and notwithstanding any other provision of this Agreement
to the contrary, Regeneron’s legal relationship under this Agreement to Sanofi, and Sanofi’s legal
relationship under this Agreement to Regeneron, shall be that of an independent contractor.
Nothing in this Agreement shall be construed to establish a relationship of partners or joint
ventures between the Parties or any of their respective Affiliates.

          20.15 Limitation of Damages. IN NO EVENT SHALL REGENERON OR SANOFI BE LIABLE FOR SPECIAL,
PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT LIMITATION, LOSS OF
PROFITS) SUFFERED BY THE OTHER PARTY, REGARDLESS OF THE THEORY OF LIABILITY (INCLUDING CONTRACT,
TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE) AND REGARDLESS OF ANY PRIOR NOTICE OF SUCH
DAMAGES. HOWEVER, NOTHING IN THIS SECTION 20.15 IS INTENDED TO LIMIT OR RESTRICT THE
INDEMNIFICATION RIGHTS AND OBLIGATIONS OF EITHER PARTY HEREUNDER WITH RESPECT TO THIRD-PARTY
CLAIMS .

          20.16 Non-Solicitation. During the Term and for a period of two (2) years thereafter, neither
Party shall solicit or
otherwise induce or attempt to induce any employee of the other Party directly involved in the
Development, Manufacture or Commercialization of any Licensed Product to leave the employment of
the other Party and accept employment with the first Party. Notwithstanding the foregoing, this
prohibition on solicitation does not apply to actions taken by a Party solely as a result of an
employee’s affirmative response to a general recruitment effort carried through a public
solicitation or general solicitation.

          20.17 No Strict Construction. This Agreement has been prepared jointly and will not be
construed against either Party.

[Remainder of page intentionally left blank; signature page follows]

84

 

     IN WITNESS WHEREOF, Sanofi, Sanofi Amerique and Regeneron have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first above written.

	 	 	 	 	 
	 	AVENTIS PHARMACEUTICALS INC.

 	 
	 	By:  	/s/ Karen Linehan
 	 
	 	 	Name:  	Karen Linehan 	 
	 	 	Title:  	Authorized Signatory 	 
	 

	 	 	 	 	 
	 	 	 
	 	By:  	                      /s/ Robin White
 	 
	 	 	Name:  	Robin White 	 
	 	 	Title:  	Authorized Signatory 	 
	 

	 	 	 	 	 
	 	SANOFI-AVENTIS AMERIQUE DU NORD

(solely for purposes of Section 15.1, 15.2 and

20.11).

 	 
	 	By:  	/s/ Jean-Luc Renard
 	 
	 	 	Name:  	Jean-Luc Renard 	 
	 	 	Title:  	Authorized Signatory 	 
	 

	 	 	 	 	 
	 	 	 
	 	By:  	                                                   /s/ Karen Linehan
 	 
	 	 	Name:  	Karen Linehan 	 
	 	 	Title:  	Authorized Signatory 	 
	 

	 	 	 	 	 
	 	REGENERON PHARMACEUTICALS, INC.

 	 
	 	By:  	/s/ Leonard Schleifer
 	 
	 	 	Name:  	Leonard Schleifer 	 
	 	 	Title:  	President & CEO 	 
	 

 

 

EXHIBIT A

Royalties For Opt-Out Products

	 	 	 
	Stage of Development at Opt-Out	 	Royalties on Net Sales
	**************

	 	********
	*************

	 	********

1

 

EXHIBIT B

Summary Outline of Initial Development Plan For REGN88 (IL-6RmAb)

**********************

1

 

SCHEDULE 1

Manufacturing Cost 

********************

1

 

SCHEDULE 2

Quarterly True-Up

At the end of each Quarter, the Parties will calculate the net payment one Party shall be required
to make to the other Party (the “Quarterly True-Up”) equal to (a) the U.S. Profit Split for
such Quarter payable to Regeneron (as set forth in Part I), plus (b) the Rest of World Profit Split
for such Quarter payable to Regeneron (as set forth in Part II), minus (c) the Development
Compensation Payment for such Quarter payable to Sanofi (as set forth in Part III), plus or minus
(d) the Regeneron Reimbursement Amount for such Quarter payable to either Regeneron or Sanofi (as
set forth in Part IV).

In the event that the Quarterly True-Up is an amount greater than zero, such amount shall be
payable by Sanofi to Regeneron in accordance with the terms set forth in Article 9. In the event
that the Quarterly True-Up is an amount less than zero, the absolute value of such amount shall be
payable by Regeneron to Sanofi in accordance with the terms set forth in Article 9. An example of
the Quarterly True-Up is shown in Part V.

I. U.S. PROFIT SPLIT

The “U.S. Profit Split” shall mean fifty percent (50%) of U.S. Profits in a Quarter.
“U.S. Profits” in a Quarter shall mean aggregate Net Sales of all Licensed Products in the
U.S. in the Quarter less the sum of (a) aggregate COGS in the U.S. in the Quarter, (b) aggregate
Shared Commercial Expenses incurred by both Parties and allocable to the U.S. in the Quarter, and
(c) aggregate Other Shared Expenses incurred by both Parties and allocable to, the U.S. in the
Quarter.

An example of a calculation of the U.S. Profit Split in a Quarter would be:

**********

1

 

II. REST OF WORLD PROFIT SPLIT

The Parties intend to share profits from Net Sales of Licensed Products in the Rest of World (or
ROW) in each Contract Year (the “Rest of World Profit Split,” defined below) based on the aggregate
amount of such Net Sales in accordance with the Target ROW Profit Split (defined below). Since the
full calculation cannot be done until aggregate Net Sales for the full Contract Year are known,
each Quarter, the Parties will calculate an estimated profit split for the Quarter based on Net
Sales for the Quarter in ROW and the Applicable ROW Percentages (defined below). Following the end
of each Contract Year, the Parties will true-up the quarterly estimates of the Rest of World Profit
Split to the Target ROW Profit Split through the ROW Profit Split Annual True-Up calculation
(defined below).

The “Target ROW Profit Split” for any Contract Year shall mean a profit split whereby ROW
Profits from ROW Net Sales of all Licensed Products up to ******* in the Contract Year are split
65% Sanofi/35% Regeneron, and ROW Profits from ROW Net Sales of all Licensed Products from *******
up to $750 million in the Contract Year are split 60% Sanofi/40% Regeneron, and ROW Profits from
ROW Net Sales of all Licensed Products greater than $750 million in the Contract Year are split 55%
Sanofi/45% Regeneron, with all profit splits calculated using the assumption that the ratio of ROW
Profits to ROW Net Sales is the same on each dollar of ROW Net Sales in the Contract Year.

The
“Rest of World Profit Split” (or “ROW Profit
Split”) for a Quarter shall mean *********

The “Applicable ROW Percentages” for the Quarter for each of Sanofi and Regeneron shall
mean the percentages to be used to calculate each Party’s Rest of World Profit Split for the
Quarter, as illustrated in the example below. At the end of each Contract Year, as part of the
calculation of the fourth Quarter Rest of World Profit Split, a “ROW Profit Split Annual
True-Up” shall also be calculated to make each Party’s Rest of World Profit Split for the
Contract Year equal to the Target ROW Profit Split. Calculation of the Applicable ROW Percentages
and Rest of World Profit Splits for a Quarter and ROW Profit Split Annual True-Up for a Contract
Year are illustrated in the example below.

**************

Notwithstanding the method of calculation shown above, in any Quarter (or for any full Contract
Year) in which the ROW Profits are negative, the Applicable ROW Percentages for such Quarter

2

 

(or for such Contract Year after calculation of the ROW Profit Split Annual True-Up) shall be
fifty-five percent (55%) for Sanofi and forty-five percent (45%) for Regeneron.

An example of a calculation of the Rest of World Profit Split in a Quarter would be:

	 	 	 	 	 	 	 
	 	 	Aggregate	 	Sanofi	 	Regeneron
	 
	Net Sales in the ROW

	 	*******
	 	******
	 	*****
	 
	 	 	 	 	 	 
	COGS

	 	*******
	 	******
	 	******
	 
	 	 	 	 	 	 
	Shared Commercial Expenses

	 	*******
	 	******
	 	****
	 
	 	 	 	 	 	 
	Other Shared Expenses

	 	*******
	 	******
	 	*****
	 
	 	 	 	 	 	 
	 	 	 	 	 
	ROW Profits

	 	******
	 	******
	 	*****
	 
	 	 	 	 	 	 
	Applicable ROW Percentages

	 	 	 	***
	 	***
	 
	 	 	 	 	 	 
	ROW Profit Split

	 	 	 	***
	 	***

III. DEVELOPMENT COMPENSATION PAYMENT

The “Regeneron Profit Split” in a Quarter shall mean the sum of (a) the U.S. Profit Split
for such Quarter payable to Regeneron plus (b) the Rest of World Profit Split for such Quarter
payable to Regeneron.

The
“Development Balance” as of the end of a Quarter
shall mean **********

If both the Development Balance as of the end of a Quarter is greater than zero and the Regeneron
Profit Split for the Quarter is greater than zero, the “Development Compensation Payment”
for such Quarter shall equal the lower of (a) ************* and (b) the Development Balance.
Otherwise, the Development Compensation Payment for the Quarter shall equal zero.

3

 

An example of a calculation of the Development Compensation Payment in a Quarter would be:

	 	 	 	 
	Development Balance at the end of the Quarter
	 	 	***
	 
	U.S. Profit Split payable to Regeneron
	 	 	***
	Rest of World Profit Split payable to Regeneron
	 	 	***
	Regeneron Profit Split
	 	 	***
	*****
	 	 	***
	Development Compensation Payment
	 	 	**

For the avoidance of doubt, the Development Costs for and Opt-Out Product until the time such
Opt-Out Product becomes an Opt-Out Product are included in the calculation of the Development
Balance.

IV. REGENERON REIMBURSEMENT AMOUNT

The
“Regeneron Reimbursement Amount” for a Quarter shall
mean *******

An example of a calculation of the Regeneron Reimbursement Amount in a Quarter would be:

	 	 	 	 	 
	Regeneron Shared Commercial Expenses in the U.S.
	 	 	****	 
	Regeneron Shared Commercial Expenses in ROW
	 	 	****	 
	Regeneron Other Shared Expenses in the U.S.
	 	 	****	 
	Regeneron Other Shared Expenses in ROW
	 	 	****	 
	Regeneron Development Costs under a Global Development Plan
	 	 	****	 
	Shared Phase 3 Trial Costs Balance
	 	 	****	 
	 
	 
	 	 	 	 
	Regeneron Reimbursement Amount
	 	 	****	 

4

 

V. EXAMPLE OF QUARTERLY TRUE-UP

An example of a calculation of the Quarterly True-Up in a Quarter would be:

	 	 	 	 	 
	U.S. Profit Split Payable to Regeneron
	 	 	 	***
	ROW Profit Split Payable to Regeneron
	 	 	 	***
	Development Compensation Payment
	 	 	 	***
	Regeneron Reimbursement Amount
	 	 	 	****
	 
	 
	 	 	 	 
	Quarterly True-Up
	 	 	 	***

In this example, Sanofi would pay Regeneron *** in accordance with the terms set forth in Article
9.

5

 

SCHEDULE 3

Sales Milestones

	 	 	 
	Aggregate annual Net Sales	 
	of all Licensed Products	 	 
	in Rest of World Countries	 	Sales Milestone
	US$1 billion

	 	************
	 
	 	 
	**********

	 	***********
	 
	 	 
	**********

	 	***********
	 
	 	 
	*********

	 	**********
	 
	 	 
	********

	 	**********

For purposes of clarification, each of the foregoing milestone payments shall be made only once and
only upon the first occurrence of each milestone. Aggregate annual Net Sales of Licensed Products
shall be determined based on the aggregate Net Sales of all Licensed Products in Rest of World
Countries in any rolling twelve (12) month period.

1

 

SCHEDULE 4

Termination Arrangements

     The rights and obligations set forth in this Schedule 4 shall apply only to the extent of the
applicable termination of this Agreement, and accordingly such rights and obligations shall apply
only with respect to the applicable Terminated Licensed Product(s) as to which, and, if applicable
pursuant to Section 19.2(a)(ii), only in the country or countries in which, this Agreement has been
terminated.

     1. Sanofi shall promptly collect and return, and cause its Affiliates and Sublicensees to
collect and return, to Regeneron or, at Regeneron’s request, destroy, all documents containing New
Information or Party Information directly related to any Terminated Licensed Product(s), and shall
immediately cease, and cause its Affiliates and Sublicensees to cease, all further use of any such
New Information or Party Information with respect to any Terminated Licensed Product(s). In
addition, at Regeneron’s request, Sanofi shall collect and transfer to Regeneron any remaining
inventory of Promotional Materials, sales training materials, samples, and product inventory.
Notwithstanding the foregoing, Sanofi may retain copies of any Party Information or New Information
to the extent required by Law, as well as retain one (1) copy of such information solely for legal
archive purposes.

     2. Regeneron and its Affiliates shall have a worldwide, fully paid-up, royalty-free (other
than any royalties due for any Royalty Products under the Discovery Agreement and any amounts
payable to Third Parties for any intellectual property or technology contributed to the Discovery
Program or Collaboration by Sanofi), exclusive right and license, with the right to sublicense
unless otherwise restricted by any License, under the Sanofi Intellectual Property existing at the
time notice of termination was given or at the effective date of termination solely for the purpose
of Developing, Manufacturing and Commercializing Terminated Licensed Product(s) in the Field in the
Territory (and solely to the extent such Sanofi Intellectual Property has, as of the date notice of
termination was given, actually been incorporated into such Licensed Product(s) or otherwise claims
or covers its use), with all other rights to such Sanofi Intellectual Property retained by Sanofi).

     3. Sanofi shall use Commercially Reasonable Efforts to provide all cooperation and assistance
reasonably requested by Regeneron to enable Regeneron (or its nominee) to assume with as little
disruption as reasonably possible, the continued Development, Manufacture, and Commercialization of
the Terminated Licensed Product(s) in the Field in the Territory. Such cooperation and assistance
shall be provided in a prompt and timely manner (having regard to the nature of the cooperation or
assistance requested) and shall include, without limitation, the following:

          (a) Sanofi shall transfer and assign to Regeneron (or its nominee) all Marketing Approvals,
Pricing Approvals, and other regulatory filings (including Registration Filings) made or obtained
by Sanofi or its Affiliates or any of its Sublicensees to the extent specifically relating to the
Terminated Licensed Product(s).

1

 

          (b) Sanofi shall assign and transfer to Regeneron (or its nominee) Sanofi’s entire right,
title and interest in and to all Product Trademarks for any Terminated Licensed and Promotional
Materials relating to the Terminated Licensed Product(s); provided that nothing herein is intended
to convey any rights in or to Sanofi’s corporate name and logos or any trade names except for the
limited rights set forth herein.

          (c) Sanofi shall provide to Regeneron (or its nominee) a copy (or originals to the extent
required by any Regulatory Authority in connection with the Development, Manufacture or
Commercialization of the Terminated Licensed Product(s) in the Field in the Territory) of all
information (including any New Information) in its possession or under its control to the extent
directly relating to the Terminated Licensed Product(s) in the Field, including, without
limitation, all information contained in the regulatory and/or safety databases, all in the format
then currently maintained by Sanofi, or such other format as may be reasonably requested by
Regeneron.

          (d) Sanofi shall use Commercially Reasonable Efforts to assign to Regeneron any applicable
sublicenses to the extent related to the Terminated Licensed Product(s) and/or contracts relating
to significant services to be performed by Third Parties to the extent related to the Development,
Manufacture or Commercialization of the Terminated Licensed Product(s) in the Field in the
Territory, as reasonably requested by Regeneron.

          (e) Without limitation of Sanofi’s other obligations under this Schedule 4, to the extent
Sanofi or its Affiliate is Manufacturing (in whole or in part) the Terminated Licensed Product(s)
for use in the Field in accordance with a Manufacturing Plan (or is designated to assume such
responsibilities), Sanofi (or its Affiliate) will perform such Manufacturing responsibilities and
supply Regeneron with Clinical Supply Requirements and/or Commercial Supply Requirements of such
Terminated Licensed Product(s), and Regeneron shall purchase such Terminated Licensed Product(s),
at the same price, and on such other terms and conditions on which Sanofi was supplying, or in the
absence of termination would have been required to supply, such Terminated Licensed Product(s),
through the second anniversary of the effective date of termination of this Agreement with respect
to such Terminated Licensed Product(s) or such shorter period if Regeneron notifies Sanofi that
Regeneron is able to Manufacture or have Manufactured such Terminated Licensed Product(s) on
comparable financial terms.

     4. Without limitation of the generality of the foregoing, the Parties shall use Commercially
Reasonable Efforts to complete the transition of the development, manufacture, and
commercialization of the Terminated Licensed Product(s) in the Field hereunder to Regeneron (or its
sublicensee or Third Party designee) as soon as is reasonably possible.

     5. For the avoidance of doubt, except as expressly provided in the Discovery Agreement or this
Agreement, Regeneron shall not be required to provide Sanofi any consideration in exchange for the
licenses or other rights granted to it pursuant to the provisions of this Schedule 4; provided,
however, that Regeneron shall be solely responsible for paying any royalties, fees or other
consideration that Sanofi may be obligated to pay to a Third Party in respect of any such transfer
or sublicense to Regeneron of such licenses or other rights.

2

 

SCHEDULE 5

Termination Arrangements

     The rights and obligations set forth in this Schedule 5 shall apply only to the extent of the
applicable termination of this Agreement, and accordingly such rights and obligations shall apply
only with respect to the applicable Terminated Licensed Product(s) as to which this Agreement has
been terminated.

     1. Regeneron shall promptly collect and return, and cause its Affiliates and sublicensees to
collect and return, to Sanofi or, at Sanofi’s request, destroy, all documents containing New
Information or Party Information of Sanofi and its Affiliates directly related to any Opt-Out
Products, and shall immediately cease, and cause its Affiliates and Sublicensees to cease, all
further use of any such New Information or Party Information with respect to the Terminated
Licensed Product(s). In addition, at Sanofi’s request, Regeneron shall collect and transfer to
Sanofi any remaining inventory of Promotional Materials, sales training materials, product samples
and product inventory. Notwithstanding the foregoing, Regeneron may retain copies of any Party
Information or New Information to the extent required by Law, as well as retain one (1) copy of
such information solely for legal archive purposes.

     2. Sanofi and its Affiliates shall have a worldwide, fully paid-up, royalty-free (other than
for amounts payable to Third Parties for any intellectual property or technology contributed to the
Discovery Program or Collaboration by Regeneron), exclusive right and license, with the right to
sublicense unless otherwise restricted by any License, under the Regeneron Intellectual Property
existing at the time notice of termination was given or at the effective date of termination solely
for the purpose of Developing, Manufacturing, and Commercializing the Terminated Licensed
Product(s) in the Field in the Territory (and solely to the extent such Regeneron Intellectual
Property has, as of the date notice of termination was given, actually been incorporated into such
Licensed Product(s) or otherwise claims or covers its use), with all other rights to such Regeneron
Intellectual Property retained by Regeneron.

     3. Regeneron shall use Commercially Reasonable Efforts to provide all cooperation and
assistance reasonably requested by Sanofi to enable Sanofi (or its nominee) to assume with as
little disruption as reasonably possible, the continued Development, Manufacture and
Commercialization of the Terminated Licensed Product(s) in the Field in the Territory. Such
cooperation and assistance shall be provided in a prompt and timely manner (having regard to the
nature of the cooperation or assistance requested) and shall include, without limitation, the
following:

          (a) Regeneron shall transfer and assign to Sanofi (or its nominee) all Marketing Approvals,
Pricing Approvals and other regulatory filings (including Registration Filings) made or obtained by
Regeneron or its Affiliates or any of its sublicensees to the extent specifically relating to the
Terminated Licensed Product(s).

1

 

          (b) Regeneron shall assign and transfer to Sanofi (or its nominee) Regeneron’s entire right,
title and interest in and to all Product Trademarks for the Terminated Licensed Product(s) and
Promotional Materials relating to the Terminated Licensed Product(s); provided that nothing herein
is intended to convey any rights in or to Regeneron’s corporate name and logos or any trade names
except for the limited rights set forth herein.

          (c) Regeneron shall provide to Sanofi (or its nominee) a copy (or originals to the extent
required by any Regulatory Authority in connection with the Development, Manufacture or
Commercialization of the Terminated Licensed Product(s) in the Field in the Territory) of all
information (including any New Information) in its possession or under its control to the extent
directly relating to the Terminated Licensed Product(s) in the Field, including, without
limitation, all information contained in the regulatory and/or safety databases, all in the format
then currently maintained by Regeneron, or such other format as may be reasonably requested by
Sanofi.

          (d) Regeneron shall use Commercially Reasonable Efforts to assign to Sanofi any applicable
sublicenses to the extent related to the Terminated Licensed Product(s) and/or contracts relating
to significant services to be performed by Third Parties to the extent related to the Development,
Manufacture or Commercialization of the Terminated Licensed Product(s) in the Field in the
Territory, as reasonably requested by Sanofi.

          (e) Without limitation of Regeneron’s other obligations under this Schedule 5, to the extent
Regeneron or its Affiliate is Manufacturing (in whole or in part) the Terminated Licensed
Product(s) for use in the Field in accordance with a Manufacturing Plan (or is designated to assume
such responsibilities), Regeneron (or its Affiliate) will perform such Manufacturing
responsibilities and supply Sanofi with Clinical Supply Requirements and/or Commercial Supply
Requirements of such Terminated Licensed Product(s), and Sanofi shall purchase such Terminated
Licensed Product(s), at the same price, and on such other terms and conditions on which Regeneron
was supplying, or in the absence of termination would have been required to supply, such Terminated
Licensed Product(s), through the second anniversary of the effective date of termination of this
Agreement with respect to such Terminated Licensed Product(s) or such shorter period if Sanofi
notifies Regeneron that Sanofi is able to Manufacture or have Manufactured such Terminated Licensed
Product(s) on comparable financial terms.

     4. Without limitation of the generality of the foregoing, the Parties shall use Commercially
Reasonable Efforts to complete the transition of the Development, Manufacture and Commercialization
of the Terminated Licensed Product(s) in the Field hereunder to Sanofi (or its Sublicensee or Third
Party designee) as soon as is reasonably possible.

     5. For the avoidance of doubt, Sanofi shall not be required to provide Regeneron any
consideration in exchange for the licenses or other rights granted to it pursuant to the provisions
of this Schedule 5; provided, however, that Sanofi shall be solely responsible for paying any
royalties, fees or other consideration that Regeneron may be obligated to pay to a Third Party in
respect of any such transfer or sublicense to Sanofi of such licenses or other rights.

2

 

SCHEDULE 6

Notices

	 	 	 	 	 
	(a)

	 	If to Sanofi or Sanofi Amerique:
	 	 
	 
	 	 	 	 
	 

	 	Aventis Pharmaceuticals Inc

200 Crossing Boulevard

Bridgewater

New Jersey 08807

USA

Attention: President R&D

Copy: General Counsel	 	 
	 
	 	 	 	 
	 

	 	With a copy to:	 	 
	 
	 	 	 	 
	 

	 	sanofi-aventis

174 Avenue de France

Paris, France 75017

Attention: General Counsel	 	 
	 
	 	 	 	 
	(b)

	 	If to Regeneron:	 	 
	 
	 	 	 	 
	 

	 	Regeneron Pharmaceuticals, Inc. 

777 Old Saw Mill River Road 

Tarrytown, New York 10591

U.S.A. 

Attention: President
Copy: General Counsel

    	 	 
	 
	 	 	 	 
	 

	 	With a copy to:	 	 
	 
	 	 	 	 
	 

	 	Skadden, Arps, Slate, Meagher & Flom LLP

One Beacon Street,
31st Floor

Boston, Massachusetts 02108

Attention: Kent A. Coit	 	 

1

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