Exhibit 10.1

Confidential Treatment has been requested for the redacted portions of this
agreement. The redactions are indicated with four asterisks [****]. A complete
version of this agreement has been filed separately with the Securities and
Exchange Commission.

AMENDED AND RESTATED COLLABORATION AGREEMENT

By and Between

SANOFI-AVENTIS US, LLC

and

REGENERON PHARMACEUTICALS, INC.

Dated as of February 23, 2015

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TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS
2

 
 
ARTICLE 2 GENERAL
15

2.1 Compliance With Law
15

2.2 Commercially Reasonable Efforts
15

2.3 Further Assurances and Transaction Approvals
15

2.4 Compliance with Third Party Agreements
15

2.5 Plans
16

 
 
ARTICLE 3 JOINT ZALTRAP COMMITTEE
16

3.1 Joint ZALTRAP Committee
16

3.2Composition; Meetings
17

3.3 Limitations on Authority
18

 
 
ARTICLE 4 LICENSE GRANTS
18

4.1 Regeneron License Grants
18

4.2 Aventis License Grants
18

4.3 Sublicenses; Subcontracting
18

4.4 No Implied License
19

4.5 Technology Transfer
19

4.6 Certain Newly Created Intellectual Property
19

 
 
ARTICLE 5 DEVELOPMENT ACTIVITIES
20

5.1 Development of Licensed Products
20

5.2 Development Plan
20

5.3 Additional Development Activities
21

5.4 Development Reports
21

5.5 Development Records
22

5.6 Obligations of The Parties And Their Affiliates
22

 
 
ARTICLE 6 COMMERCIALIZATION
22

6.1 Commercialization of Licensed Products
22

6.2 Commercialization Plan
22

6.3 Commercialization Reports
23

6.4 Commercialization Records
23

6.5 Booking of Sales and Licensed Product Distribution
24

6.6 [****]
24

6.7 Restrictions on Sales Outside the Field
24

6.8 Inventory Management
24

6.9 Medical and Consumer Inquiries
24

6.10 Market Exclusivity Extensions
25

6.11 Non-Compete; Activities Outside of the Agreement
25

6.12 Post Marketing Clinical Trials
27

i

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ARTICLE 7 REGULATORY AFFAIRS
27

7.1 Ownership of Approvals and Registration Filings
27

7.2 Rights of Reference
27

7.3 Regulatory Coordination and Assistance
28

7.4 Pharmacovigilance and Safety Data Exchange
31

7.5 Regulatory Inspection or Audit
31

7.6 Recalls and Other Corrective Actions
32

7.7 Cost of Recalls and Other Corrective Actions
32

7.8 Licensed Product Labeling
32

 
 
ARTICLE 8 MANUFACTURING AND SUPPLY
32

8.1 Supply Agreement
33

8.2 Aventis Manufacturing and Supply Obligations
33

8.3 Funded Assets
33

 
 
ARTICLE 9 PAYMENTS
33

9.1 Payments.
33

9.2 Development Balance; Other Payment Obligations
34

9.3 Net Sales Report
34

9.4 Third Party Payment Amounts
34

9.5 Regeneron Costs
34

9.6 Profit Sharing Payment
34

9.7 Payments with respect to Batches under the Supply Agreement
36

9.8 Quarterly Invoicing and Payment
37

9.9 Payment Method and Currency
37

9.10 Late Payments
38

9.11 Taxes
38

 
 
ARTICLE 10 DISPUTE RESOLUTION
38

10.1Resolution of Disputes
38

10.2 Legal Disputes
38

10.3 Escalation to Executive Officers
39

10.4 No Waiver
39

 
 
ARTICLE 11 TRADEMARKS AND CORPORATE LOGOS
39

11.1 Corporate Logos
39

11.2 Selection of Product Trademarks
39

11.3 Ownership of Product Trademarks
39

11.4 Prosecution and Maintenance of Product Trademarks
40

11.5 License to the Licensed Product Trademarks
40

11.6 Use of Corporate Names
41

 
 
ARTICLE 12 NEWLY CREATED INVENTIONS
41

12.1 Ownership of Newly Created Intellectual Property
41

12.2 Prosecution and Maintenance of Patents
43

ii

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12.3 Interference, Opposition and Reissue
46

 
 
ARTICLE 13 INTELLECTUAL PROPERTY LITIGATION
46

13.1 Enforcement of Patents and Product Trademarks
46

13.2 Patent Marking
47

13.3 Third-Party Infringement Claims
47

13.4 Invalidity or Unenforceability Defenses or Actions
48

 
 
ARTICLE 14 BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS
49

14.1 Books and Records
49

14.2 Audits and Adjustments
49

14.3 GAAP/IAS/IFRS
50

 
 
ARTICLE 15 REPRESENTATIONS AND WARRANTIES
50

15.1 Due Organization, Valid Existence and Due Authorization
50

15.2 Knowledge of Pending or Threatened Litigation
50

15.3 Disclaimer of Warranties
50

 
 
ARTICLE 16 CONFIDENTIALITY
51

16.1 Confidential Information
51

16.2 Exclusions
51

16.3 Permitted Disclosures and Uses
51

16.4 Injunctive Relief
53

16.5 Publication of New Information
53

16.6 Other Publications
53

 
 
ARTICLE 17 INDEMNITY
54

17.1 Indemnity and Insurance
54

17.2 Indemnity Procedure
56

 
 
ARTICLE 18 FORCE MAJEURE
57

 
 
ARTICLE 19 TERM AND TERMINATION
57

19.1 Term/Expiration of Term
57

19.2 Termination Without Cause
57

19.3 Termination For Material Breach
58

19.4 Termination for Aventis’ Material Breach of the Supply Agreement
58

19.5 Termination for Insolvency
58

19.6 Termination for Breach of Investor Agreement
59

19.7 Effect of Termination/Expiration
59

19.8 Survival of Obligations
60

 
 
ARTICLE 20 MISCELLANEOUS
61

20.1 Governing Law; Submission to Jurisdiction
61

20.2 Waiver
61

iii

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20.3 Notices
62

20.4 Entire Agreement
62

20.5 Amendments
62

20.6 Headings
62

20.7 Severability
62

20.8 Registration and Filing of the Agreement
62

20.9 Assignment
63

20.10 Successors and Assigns
63

20.11 Affiliates
63

20.12 Counterparts
63

20.13 Third-Party Beneficiaries
63

20.14 Relationship of the Parties
63

20.15 Limitation of Damages
64

20.16 Non-Solicitation
64

20.17 Rejection of Agreement in Bankruptcy
64

20.18 Construction
65

iv

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AMENDED AND RESTATED COLLABORATION AGREEMENT

THIS AMENDED AND RESTATED COLLABORATION AGREEMENT (“Agreement”), dated as of
February 23, 2015 (the “Amendment Execution Date”), amends and restates,
effective as of July 1, 2014 (the “Amendment Effective Date”) the Collaboration
Agreement, dated as of September 5, 2003 (the “Effective Date”), as amended, by
and between Sanofi-Aventis US, LLC (as successor in interest to Aventis
Pharmaceuticals Inc.), a corporation organized under the laws of Delaware and
having a principal place of business at 55 Corporate Drive, Bridgewater, NJ
08807 (“Aventis”), 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 (“Regeneron”) (with each of
Aventis and Regeneron referred to herein individually as a “Party” and
collectively as the “Parties”).
WHEREAS, Regeneron has developed certain VEGF inhibitor molecules referred to
herein as VEGF Trap Products, and Regeneron and Aventis have collaborated on the
development and commercialization of certain VEGF Trap Products in the
Territory; and
WHEREAS, Regeneron and Aventis wish to amend this Agreement in part and
terminate this Agreement in part so that Aventis has the right to continue to
commercialize the Licensed Product and to develop the Licensed Product for
additional oncology indications on revised financial and other terms, and the
rights to other VEGF Products and other indications shall revert to Regeneron
all as set forth herein.
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:

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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    “Actual Fully Burdened Manufacturing Cost” shall have the meaning set
forth in Schedule 11.
1.2    “Additional Major Market Country” shall mean any country in the
Territory, other than the Major Market Countries referred to in clause (a) of
the definition thereof, in which Net Sales in the immediately prior Contract
Year were [****] or more of aggregate Net Sales in the Territory and such
designation shall remain effective from and after January 1 of such Contract
Year and each Contract Year thereafter as long as Net Sales in such country in
the immediately preceding Contract Year(s) are [****] or more of aggregate Net
Sales in the Territory in such Contract Year(s). Notwithstanding the foregoing,
the Parties shall have the right to mutually agree that a country that exceeds
[****] aggregate Net Sales threshold in a given Contract Year shall not be an
Additional Major Market Country if such country is not expected to exceed such
[****] aggregate Net Sales threshold on an ongoing basis.
1.3    “Affiliate” shall mean, with respect to any Person, any other Person that
controls, is controlled by or is under common control with such first Person. A
Person shall be deemed to control another Person if such first Person possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such first 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 Aventis 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 Aventis or any
of its Affiliates.
1.4    “Aggregate Actual Fully Burdened Manufacturing Cost” shall have the
meaning set forth in Section 9.7(c).
1.5    “Aggregate Profit Sharing Payment” shall have the meaning set forth in
Section 9.6(b).
1.6    “Agreement” shall have the meaning set forth in the introductory
paragraph, including all Schedules and Exhibits.

2

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1.7    “Amendment Effective Date” shall have the meaning set forth in the
introductory paragraph.
1.8    “Amendment Execution Date” shall have the meaning set forth in the
introductory paragraph.
1.9    “Ancillary Agreement” shall mean the Supply Agreement and the Investor
Agreement.
1.10    “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 testing,
manufacture, Development, Commercialization, sale, storage or transport of, or
expanded labeling for, such Licensed Product in any country, and shall include,
without limitation, an approval, registration, license or authorization granted
in connection with any Registration Filing.
1.11    “Assigned Regeneron Regulatory Documentation” has the meaning set forth
in Section 7.1.
1.12    “Aventis” shall have the meaning set forth in the introductory
paragraph.
1.13    “Aventis Know-How” shall mean (a) all Know-How that is conceived,
developed, created or otherwise made by or on behalf of Aventis (or its
Affiliates or its or their sublicensees or Distributors) under or in connection
with this Agreement during the Term (or any transition period as provided in
Schedule 6 or Schedule 7), and (b) all Know-How that (i) is Controlled as of the
Effective Date and at any time during the Term by Aventis or any of its
Affiliates (other than by operation of the license and other grants in ARTICLE
4) and (ii) relates to a VEGF Trap, in each case ((a) and (b)), excluding any
Joint Inventions. Aventis Know-How shall include New Information of Aventis.
1.14    “Aventis Indemnitees” shall have the meaning set forth in Section
17.1(b).
1.15    “Aventis Intellectual Property” shall mean the Aventis Patent Rights and
Aventis Know-How.
1.16    “Aventis Patent Rights” shall mean (a) those Patents Controlled as of
the Effective Date or hereafter during the Term by Aventis or any of its
Affiliates (other than by operation of the license in ARTICLE 4) that include at
least one claim that would be infringed by the manufacture, use, sale, offer for
sale or import of any VEGF Product and (b) those Patents that (i) claim or cover
the Aventis Know-How and (ii) are Controlled by Aventis or any of its Affiliates
(other than by operation of the license and other grants in ARTICLE 4).
1.17    “Aventis Sole Inventions” shall have the meaning set forth in Section
12.1(a).
1.18    “Aventis Trademarks” shall have the meaning set forth in Section 11.3.
1.19    “Batch” shall have the meaning set forth in the Supply Agreement.

3

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1.20    “Batch Number” shall have the meaning set forth in Section 9.7(c).
1.21    “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 outside of
the United States.
1.22    “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.
1.23    “Calendar Quarter” shall mean each successive period of three (3)
calendar months commencing on January 1, April 1, July 1 and October 1 during
the Term, except that for purposes of ARTICLE 9 the first Calendar Quarter shall
commence on the Amendment Effective Date and shall end on December 31, 2014 and
the last Calendar Quarter shall end on the last day of the Term.
1.24    “Clinical Supply Requirements” shall mean, with respect to a Licensed
Product, the quantities of such Licensed Product that are required by Aventis
(a) for Development, including the conduct of pre-clinical studies and Clinical
Trials in connection with the Development Plan in order to obtain Approval of
such Licensed Product in the Field in any country in the Territory 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 any country in the Territory or (b) for any Non-Approval Trial.
1.25    “Clinical Trial” shall mean any clinical trial conducted for the purpose
of or which results in obtaining data to support or be included in a
Registration Filing, including any clinical trial conducted or sponsored by a
Party’s medical affairs department which is referenced in a BLA solely in
connection with an integrated safety database.
1.26    “CMC” shall mean chemistry, manufacturing and controls.
1.27    “Collaboration Purpose” has the meaning set forth in Section 5.6.
1.28    “Commercial Supply Requirements” shall mean, with respect to each
Licensed Product, quantities of such Licensed Product as are required by Aventis
to fulfill Aventis’ requirements for commercial sales and product sampling with
respect to such Licensed Product in the Field in the Territory or any country in
the Territory, as the case may be.
1.29    “Commercialize” or “Commercialization” shall mean any and all activities
directed to marketing, promoting, detailing, distributing, importing,
commercializing, offering for sale, having sold and/or selling a Licensed
Product, including sampling and conducting Non-Approval Trials.
1.30    “Commercialization Plan” has the meaning set forth in Section 6.2.

4

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1.31    “Commercially Reasonable Efforts” shall mean, with respect to the
efforts to be expended by a Party with respect to any objective, reasonable,
diligent, good faith efforts to accomplish such objective as such Party would
normally use to accomplish a similar objective under similar circumstances, it
being understood and agreed that such efforts shall be consistent with the
Collaboration Purpose, and substantially equivalent to those efforts and
resources commonly used by a Party for a product owned by it, which product is
at a similar stage in its development or product life and is of similar market
potential. Commercially Reasonable Efforts shall be determined on a
market-by-market and product-by-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 alternative products that are in the
marketplace or under development by Third Parties and other technical,
scientific, legal, medical marketing and competitive factors. It is anticipated
that the level of effort will change over time. In determining whether a Party
has used Commercially Reasonable Efforts, the payments made or required to be
made hereunder or under the Supply Agreement shall not be factors weighed (that
is, a Party may not apply lesser resources or efforts in support of a Licensed
Product because it must make any payments hereunder or under the Supply
Agreement). In determining whether Aventis has used Commercially Reasonable
Efforts with respect to the Commercialization of Licensed Products, a failure by
Regeneron to satisfy its obligations to supply Formulated Bulk Licensed Product
pursuant to Section 3.1 of the Supply Agreement, to the extent amounts supplied
by Regeneron are insufficient to meet the Commercial Supply Requirements of
Licensed Product, shall be a relevant factor to take into account; provided,
however, that, for clarity, in no event shall this sentence apply with respect
to Aventis’ obligations under Section 8.2.
1.32    “Contract Year” shall mean the period beginning on the Effective Date
and ending on December 31, 2003, and each succeeding twelve (12) month period
thereafter during the Term, except that the last Contract Year shall end on the
last day of the last Calendar Quarter.
1.33    “Control” means, with respect to any item of New Information or Party
Information, material, regulatory documentation, Patents or other intellectual
property right, possession of the right, whether directly or indirectly and
whether by ownership, license or otherwise, to assign, or grant a license,
sublicense, right of reference or other right to or under such New Information
or Party Information, material, regulatory documentation, Patents or other
intellectual property right as provided for herein without violating the terms
of any agreement with any Third Party.
1.34    “Controlling Party” shall mean Regeneron with respect to the filing,
prosecution and maintenance of a Joint Patent Right that primarily claims a VEGF
Product (or the making or use thereof, including, without limitation, any
devices for the administration of such VEGF Product or any component thereof),
and Aventis in the case of all other Joint Patent Rights.
1.35    “CPI’’ shall mean the Consumer Price Index – Urban Wage Earners and
Clerical Workers, U.S. City Average, All Items, 1982-1984 = 100, published by
the United States Department of Labor, Bureau of Statistics (or its successor
equivalent index).

5

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1.36    “CPI Adjustment” shall mean 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.
1.37    “Cumulative Net Sales” shall have the meaning set forth in Section
9.6(c).
1.38    “Damages” shall have the meaning set forth in Section 17.1(a).
1.39    “Default Interest Rate” shall have the meaning set forth in Section
9.10.
1.40    “Develop” or “Development” shall mean (a) activities directly and
specifically relating to the pre-clinical and clinical drug development of a
Licensed Product, including, without limitation, test method development,
stability testing with respect to Licensed Product manufactured by or on behalf
of Aventis (for clarity, other than Product supplied by Regeneron pursuant to
the Supply Agreement), assay development, toxicology, formulation, quality
assurance/quality control development, technology transfer, statistical
analysis, process development, pharmacokinetic studies, Clinical Trials
(including research to design Clinical Trials and develop target product
profiles), regulatory affairs, drug safety surveillance activities, and
Approvals, (b) any other research and development activities with respect to a
Licensed Product and (c) any pre-launch marketing activities (including, without
limitation, market research and analysis, and health economics) performed prior
to First Commercial Sale of such Licensed Product.
1.41    “Development Balance” has the meaning set forth in this Agreement prior
to the Amendment Execution Date.
1.42    “Development Plan” shall have the meaning set forth in Section 5.2.
1.43    “Distributor’’ shall mean any Third Party contractually engaged by
Aventis to distribute the Licensed Products in a country in the Territory (other
than the United States).
1.44    “Effective Date” shall have the meaning set forth in the introductory
paragraph.
1.45    “EMA” shall mean the European Medicines Agency or any successor agency
thereto.
1.46     “Estimated Fully Burdened Batch Price” shall have the meaning set forth
in Section 9.7(b).
1.47    “Excluded Ocular Field” shall mean all local administration of any VEGF
Product to the eye, including by topical, intravitreal, periorbital, implants or
other means, for the treatment or diagnosis of any ocular disease or disorder.
1.48    “Excluded Ocular VEGF Products” shall means any VEGF Product delivered
via local administration to the eye, including by topical, intravitreal,
periorbital, implants or other means.

6

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1.49    “Excluded Rights” has the meaning set forth in Section 4.6.
1.50    “Executive Officers” shall mean the Chief Executive Officer of Regeneron
and the Chief Executive Officer or Chief Operating Officer of Aventis.
1.51    “Existing Licenses” shall mean the agreements listed in Schedule 1.
1.52    “EYLEA Drug Substance” means the biological compound aflibercept.
1.53    “FDA” shall mean the United States Food and Drug Administration and any
successor agency thereto.
1.54    “Field” means (a) oncology (other than for treatments using local
administration to the eye, including by topical, intravitreal, periorbital,
implants or other means) and (b) other indications (other than the Excluded
Ocular Field) as may be mutually agreed by the Parties in writing.
1.55    “Finished Licensed Product” shall mean Licensed Product in its finished,
labeled and packaged form, ready for sale to the market.
1.56    “Firm Order” shall have the meaning set forth in the Supply Agreement.
1.57    “First Commercial Sale” shall mean the first sale of any Licensed
Product, following receipt of Marketing Approval, by a Party or one of its
Affiliates, or its or their sublicensees or Distributors to a Third Party in the
relevant country in the Territory, as the case may be, on arm’s length
commercial terms. Sales for test marketing, Clinical Trial or Non-Approval Trial
purposes or compassionate or similar use shall not be considered to constitute a
First Commercial Sale.
1.58    “Force Majeure” shall have the meaning set forth in ARTICLE 18.
1.59    “Formulated Bulk Licensed Product” shall mean the Licensed Products
formulated into solution, ready for storage or shipment to a manufacturing
facility, to allow processing into the final dosage form.
1.60    “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 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 hereof shall be [****] hours
per year.
1.61    “Funded Assets MOU” shall mean that certain memorandum of understanding
and agreement by and between Regeneron and sanofi-aventis U.S., LLC, dated May
7, 2008.
1.62    “GAAP” shall mean generally accepted accounting principles in the United
States.

7

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1.63    “Genentech Settlement Agreement” shall mean that certain Non-Exclusive
License and Settlement Agreement between Genentech, Inc., Regeneron, Sanofi U.S.
Services, Inc., and sanofi-aventis U.S. LLC, dated as of May 17, 2013.
1.64    “Genentech Settlement Letter” shall mean that certain letter agreement
by and between Regeneron, Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S.
LLC, dated May 17, 2013, pursuant to which Regeneron, Sanofi U.S. Services, Inc.
and Sanofi-Aventis U.S. LLC allocated responsibility for certain amounts payable
to Genentech, Inc. under the Genentech Settlement Agreement.
1.65    “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 EMA, ICH or other country regulatory
agencies, as applicable.
1.66    “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.
1.67    “IAS/IFRS” shall mean International Accounting Standards/International
Financial Reporting Standards of the International Accounting Standards Board.
1.68    “ICH” shall mean the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human Use.
1.69    “IND” shall mean, with respect to each Licensed Product, an
Investigational New Drug Application filed with the FDA 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 of the United States.
1.70    “Indemnified Party” shall have the meaning set forth in Section 17.2(a).
1.71    “Indemnifying Party” shall have the meaning set forth in Section
17.2(a).
1.72    “Infringement” shall have the meaning set forth in Section 13.1(a).
1.73    “Investor Agreement” has the meaning set forth in Section 19.6. The
Investor Agreement shall constitute an Ancillary Agreement.
1.74    “Joint Intellectual Property” shall mean Joint Patent Rights and Joint
Inventions.
1.75    “Joint Inventions” shall have the meaning set forth in Section 12.1(b).
1.76    “Joint Patent Rights” shall mean Patents that cover a Joint Invention.

8

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1.77    “Joint ZALTRAP Committee” or “JZC” shall have the meaning set forth in
Section 3.1.
1.78    “Know-How” shall mean 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 (whether or not patentable or otherwise protected by trade
secret Law).
1.79    “Law” or “Laws” shall mean all laws, statutes, rules, regulations,
orders, judgments, injunctions and/or ordinances of any Governmental Authority
in the Territory.
1.80    “Lead Litigation Party” shall have the meaning set forth in Section
13.1(b).
1.81    “Legal Dispute” shall mean any dispute, controversy or claim related to
compliance with this Agreement or the Supply Agreement or the validity, breach,
termination or interpretation of this Agreement or the Supply Agreement,
including any dispute with respect to whether (a) the Development Plan or a
proposed amendment thereto does not constitute Commercially Reasonable Efforts
or otherwise satisfy Aventis’ obligations under this Agreement with respect to a
Licensed Product; (b) Aventis has used Commercially Reasonable Efforts to
Develop, and obtain and maintain Approvals for, the Licensed Products in the
Field in the Territory and carry out the Development activities assigned to it
in the Development Plan pursuant to Section 5.1; or (c) Aventis has used
Commercially Reasonable Efforts to Commercialize the Licensed Products
throughout the Territory pursuant to Section 6.1.
1.82    “Licensed Compound” means the biological compound ziv-aflibercept.
1.83    “Licensed Product” means any product that is comprised of or contains
the Licensed Compound as the sole active ingredient, but excluding any Excluded
Ocular VEGF Products.
1.84    “Litigation Party” shall have the meaning set forth in Section 13.1(b).
1.85    “[****] Facility” shall mean the facility owned by [****] located in
[****].
1.86    “Major Market Country” shall mean any of the Original Major Market
Countries and any of the Additional Major Market Countries.
1.87    “Marketing Approval” shall mean Approval required for the marketing and
sale of a Licensed Product in a country in the Territory.
1.88    “Modified Clause” shall have the meaning set forth in Section 20.7.
1.89    “Net Sales” shall mean the gross amount invoiced for bona fide arms’
length sales of Licensed Products in the Field in the Territory by Aventis, its
Affiliates, or its or their sublicensees or Distributors to Third Parties (other
than sublicensees or Distributors), less the following deductions, determined in
accordance with IAS/IFRS (or GAAP for the United States) consistently applied:

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(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 the Licensed
Products;
(d)    Third Party cash rebates and chargebacks related to sales of the 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 governmental 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 Products
falling within 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 9.9. Sales between
Aventis and its Affiliates, or its or their sublicensees or Distributors for
resale shall be disregarded for purposes of calculating Net Sales unless such
purchaser is an end user of the Licensed Product. Any of the items set forth
above that would otherwise be deducted from the invoice price in the calculation
of Net Sales, but that 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 Aventis or its Affiliate, as
applicable.
1.90    “New Information” shall mean any and all ideas, inventions, information,
data, writings, discoveries, improvements, or materials not generally known to
the public that arise or are conceived or developed by (a) either Party or its
Affiliates or (b) the Parties or their Affiliates jointly, in each case ((a) and
(b)) under or in connection with this Agreement or any Ancillary

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Agreement during the Term and to the extent specifically related to any VEGF
Products, including, without limitation, information and data included or
referenced in the Registration Filings made under this Agreement and any
Approvals.
1.91    “New License” shall mean any license entered into by a Party (or its
Affiliates) with a Third Party after the Amendment Execution Date, other than
Existing Licenses, required for the manufacture, development or
commercialization of any VEGF Product in such Party’s respective field (i.e.,
with respect to Aventis, the Field, and with respect to Regeneron, outside of
the Field). For clarity, any New License (as defined in this Agreement prior to
the Amendment Execution Date) entered into prior to the Amendment Execution Date
shall constitute an Existing License.
1.92    “Non-Approval Trial” shall mean any clinical trial of a Licensed Product
in the Field in the Territory other than a Clinical Trial.
1.93    “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.
1.94    “Original Major Market Country” shall mean any of [****].
1.95    “Party” or “Parties” shall have the meaning set forth in the
introductory paragraph.
1.96    “Party Information” shall mean, with respect to a Party, all ideas,
inventions, information, data, writings, discoveries, improvements, or materials
not generally known to the public (in each case, other than New Information)
that are provided to or made available in connection with this Agreement or any
Ancillary Agreement by either Party or their respective Affiliates to the other
Party or its Affiliates whether furnished before or after the Effective Date,
including, without limitation, information and materials in relation to
research, development, manufacturing, promotion, marketing, distributing and
selling of VEGF Products hereunder, and information and materials on substances,
formulations, techniques, technology, equipment, data, reports, Know-How,
sources for supply, patent position, business plans, sales management procedures
and other general business and operational processes and procedures. With
respect to each Party, Party Information does not include New Information.
1.97    “Patents” shall mean (a) all national, regional and international
patents and patent applications, including, without limitation, provisional
patent applications; (b) all patent applications filed either from such patents,
patent applications or provisional applications or from an application claiming
priority from either of these, including, without limitation, divisionals,
continuations, continuations-in-part, provisionals, converted provisionals and
continued prosecution applications; (c) any and all patents that have issued or
in the future issue from the foregoing patent applications ((a) and (b)),
including, without limitation, utility models, petty patents, innovation patents
and design patents and certificates of invention; (d) any and all extensions or
restorations by existing or future extension or restoration mechanisms,
including, without limitation, revalidations, reissues, re-examinations and
extensions (including any

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supplementary protection certificates and the like) of the foregoing patents or
patent applications ((a), (b) and (c)); and (e) any similar rights, including,
without limitation, so-called pipeline protection or any importation,
revalidation, confirmation or introduction patent or registration patent or
patent of additions to any of such foregoing patent applications and patents.
1.98    “Payment Total” shall have the meaning set forth in Section 9.7(c).
1.99     “Period Costs” shall have the meaning set forth in Schedule 11.
1.100    “Person” shall mean and include an individual, partnership, joint
venture, limited liability company, a corporation, a firm, a trust, an
unincorporated organization and a government or other department or agency
thereof.
1.101    "[****] Product” shall mean a biopharmaceutical product that [****].
1.102    “Plan” shall mean any Development Plan or Commercialization Plan.
1.103    “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 tor pharmaceutical
products for reimbursement or otherwise.
1.104    “Product” shall have the meaning set forth in the Supply Agreement.
1.105    “Product Trademark” shall mean, with respect to each Licensed Product,
the trademark selected by Aventis for use on such Licensed Product and/or
accompanying logos, trade dress and/or other indicia of origin, in each case as
selected by Aventis.
1.106    “Profit Sharing Payment” shall have the meaning set forth in Section
9.6(b).
1.107    “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.
1.108    “Publishing Party” shall have the meaning set forth in Section 16.3.
1.109    “Reconciliation Amount” shall have the meaning set forth in
Section 9.7(c)(i).
1.110    “Regeneron” shall have the meaning set forth in the introductory
paragraph.
1.111    “Regeneron Costs” shall mean, with respect to any (a) activity that is
requested or authorized by Aventis in writing, (b) activity that relates to the
Development, manufacture or Commercialization of the Licensed Product and is
requested or otherwise recommended by a Regulatory Authority, including
activities in connection with obtaining and maintaining

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Regulatory Approvals for the Licensed Products in the Field in the Territory,
(c) pharmacovigilance activity that is related to the Licensed Products, (d)
activity that relates to the stability testing of the Licensed Products, and (e)
Period Costs, in each case ((a), (b), (c), (d) and (e)), (y) all Out-of-Pocket
Costs and (z) an amount equal to the product of (i) the number of FTEs required
for such activity and (ii) the Regeneron FTE Rate. For clarity, the Regeneron
Costs shall not include any costs or expenses otherwise included in Actual Fully
Burdened Manufacturing Costs.
1.112    “Regeneron FTE Rate” shall mean (a) in Contract Year 2014, US$[****]
(b) in Contract Year 2015, US$[****], and (c) in Contract Year 2016 and
subsequent Contract Years, the rate in the prior Contract Year adjusted as of
January 1 of Contract Year 2016 and each such subsequent Contract Year by the
CPI Adjustment.
1.113    “Regeneron Indemnitees” shall have the meaning set forth in Section
17.1(a).
1.114    “Regeneron Intellectual Property” shall mean the Regeneron Patent
Rights and the Regeneron Know-How.
1.115    “Regeneron Know-How” shall mean (a) all Know-How that is conceived,
developed, created or otherwise made by or on behalf of Regeneron (or its
Affiliates or its or their sublicensees or Distributors) under or in connection
with this Agreement during the Term, and (b) all Know-How that (i) is Controlled
as of the Effective Date and at any time during the Term by Regeneron or any of
its Affiliates (other than by operation of the license and other grants in
ARTICLE 4) and (ii) relates to a VEGF Trap, in each case ((a) and (b)),
excluding any Joint Inventions. Regeneron Know-How shall include New Information
of Regeneron.
1.116    “Regeneron Licensed Product Domain Names” shall mean those domain names
that are Controlled by Regeneron or its Affiliates as of the Effective Date that
are set forth on Schedule 9.
1.117    “Regeneron Patent Rights” shall mean (a) those Patents Controlled as of
the Effective Date or hereafter during the Term by Regeneron or any of its
Affiliates (other than by operation of the license in ARTICLE 4) that include at
least one claim that would be infringed by the manufacture, use, sale, offer for
sale or import of any Licensed Product and (b) those Patents that (i) claim or
cover the Regeneron Know-How and (ii) are Controlled by Regeneron or any of its
Affiliates (other than by operation of the license and other grants in ARTICLE
4).
1.118    “Regeneron Sole Inventions” shall have the meaning set forth in Section
12.1(a).
1.119    “Regeneron Trademarks” shall have the meaning set forth in Section
11.2.
1.120    “Registration Filing” shall mean the submission to the relevant
Regulatory Authority of an appropriate application seeking any Approval, and
shall include, without limitation, any testing, marketing authorization
application, supplementary application or variation thereof, IND, BLA, or any
equivalent applications in any country.

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1.121    “Regulatory Authority” shall mean any federal, national, multinational,
state, provincial or local regulatory agency, department, bureau or other
governmental entity with authority over the testing, marketing, pricing,
reimbursement and/or sale of any VEGF Product in a country in the Territory,
including, without limitation, the FDA in the United States and EMA in Europe.
1.122    “Sole Inventions” shall have the meaning set forth in Section 12.1(a).
1.123    “Supply Agreement” shall have the meaning set forth in Section 8.1.
1.124    “Supply Term” shall mean the Term of the Supply Agreement, as defined
in the Supply Agreement.
1.125    “SWI” shall mean Sanofi Withrop Industrie or such other Affiliate of
Aventis that is a party to the Supply Agreement.
1.126    “Term” shall have the meaning set forth in Section 19.1(a).
1.127    “Terminated Territory” means each country with respect to which this
Agreement is terminated by Aventis pursuant to Section 19.2(a) or, if this
Agreement is terminated in its entirety, the entire Territory.
1.128    “Termination Notice Period” shall have the meaning set forth in Section
19.2.
1.129    “Territory” shall mean all the countries of the world, other than the
Terminated Territory.
1.130    “Third Party” shall mean any Person other than Aventis or Regeneron or
any Affiliate of either Party.
1.131    “Third Party Claim” shall have the meaning set forth in Section
17.1(a).
1.132    “Third Party Payment Amount” shall mean, with respect to a period, the
royalties and other amounts payable to a Third Party with respect to the
manufacture, Development or Commercialization of a Licensed Product in the Field
in the Territory in such period under any Existing License or New License to
which Regeneron is a party, other than the Genentech Settlement Agreement.
1.133    “United States” or “U.S.” shall mean the United States of America
(including its territories and possessions and its military bases and
commissaries wherever located in the Territory) and Puerto Rico.
1.134    “VEGF Products” shall mean [****].
1.135    “VEGF Trap” shall mean [****].

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1.136    “VEGF Trap Product” shall mean any pharmaceutical products for human
and/or animal use which includes VEGF Trap as an active ingredient, alone or in
combination with one or more other active ingredients, for any and all
indications.
ARTICLE 2
GENERAL
2.1    Compliance With Law. Both Aventis and Regeneron, and their respective
Affiliates, shall perform their obligations under this Agreement in an effort to
Develop, manufacture, and Commercialize Licensed Products 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.
2.2    Commercially Reasonable Efforts. Subject to the terms of this Agreement,
each Party (and its Affiliates) shall use Commercially Reasonable Efforts to
fulfill all responsibilities assigned to it under this Agreement and any
then-applicable Plans.
2.3    Further Assurances and Transaction Approvals. Upon the terms and subject
to the conditions hereof, each of the Parties will use all 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 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.
2.4    Compliance with Third Party Agreements.
(a)    Aventis agrees to comply with the obligations set forth in (i) the
Existing Licenses or the New Licenses to which it is a party and to notify
Regeneron of any terms or conditions in any such Existing License or New License
with which Regeneron is required to comply as a licensee or sublicensee, as the
case may be, and (ii) any other material agreement to which Aventis is a party
and that is related to the development, manufacture or commercialization of VEGF
Products, including, without limitation, any obligations to pay royalties, fees
or other amounts due thereunder, in each case ((i) and (ii)), as necessary to
preserve the rights granted to Regeneron and the obligations assumed by Aventis
under this Agreement with respect to VEGF Products inside and outside the Field
in the Territory. Moreover, Aventis shall (A) take all actions reasonably
necessary to ensure Aventis’ compliance

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with (1) any such terms and conditions of any Existing License or New License
with which Aventis is required to comply as a licensee or sublicensee, as the
case may be, and (2) any such material agreement referred to in clause (ii)
above and (B) not terminate or amend any Existing License, New License or any
other material agreement referred to in clause (ii) above, in each case, without
the prior written consent of Regeneron, such consent not to be unreasonably
withheld or delayed, if such termination or amendment would impose any material
liability or restriction on Regeneron with respect to the development,
manufacture or commercialization of VEGF Products (other than Licensed Products
in the Field in the Territory) in the Territory.
(b)    Regeneron agrees to comply with the obligations set forth in (i) the
Existing Licenses or the New Licenses to which it is a party and to notify
Aventis of any terms or conditions in any such Existing License or New License
with which Aventis is required to comply as a licensee or sublicensee, as the
case may be, and (ii) any other material agreement to which Regeneron is a party
and that is related to the Development, manufacture or Commercialization of
Licensed Products in the Field in the Territory, including, without limitation,
and subject to Section 9.4, any obligations to pay royalties, fees or other
amounts due thereunder, in each case ((i) and (ii)), as necessary to preserve
the rights granted to Aventis and the obligations assumed by Regeneron under
this Agreement with respect to Licensed Products in the Field in the Territory.
Moreover, Regeneron shall (A) take all actions reasonably necessary to ensure
Regeneron’s compliance with (1) any such terms and conditions of any Existing
License or New License with which Regeneron is required to comply as a licensee
or sublicensee, as the case may be, and (2) any such material agreement referred
to in clause (ii) above and (B) not terminate or amend any Existing License, New
License or any other material agreement referred to in clause (ii) above, in
each case, without the prior written consent of Aventis, such consent not to be
unreasonably withheld or delayed, if such termination or amendment would impose
any material liability or restriction on Aventis with respect to the
Development, manufacture or Commercialization of Licensed Products in the Field
in the Territory.
(c)    Notwithstanding anything in this Agreement to the contrary, Aventis shall
not be permitted to enter into any New License pursuant to which it obtains
rights to VEGF Products outside of the Field in the Territory and Regeneron
shall not be permitted to enter into any New License pursuant to which it
obtains rights to VEGF Products in the Field in the Territory, in each case,
without the prior written consent of the other Party.
2.5    Plans. Aventis shall undertake all Development and Commercialization
activities in accordance with approved Plans. The Parties may agree to amend all
Plans from time to time as circumstances may require pursuant to the terms of
this Agreement.
ARTICLE 3
JOINT ZALTRAP COMMITTEE
3.1    Joint ZALTRAP Committee. Within thirty (30) days after the Effective
Date, the Parties shall establish a joint ZALTRAP committee (the “Joint ZALTRAP
Committee” or “JZC”), which shall have the following responsibilities:

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(a)    coordinating the Parties’ (or its Affiliates’) activities under the
Supply Agreement, including the sharing of information between the Parties with
respect to Regeneron’s Available Capacity and Aventis’s projected Clinical
Supply Requirements and Commercial Supply Requirements;
(b)    coordinating the exchange and review of the Development Plan, the
Commercialization Plan and any Development or Commercialization reports
described in Sections 5.4 and 6.3 between the Parties;
(c)    coordinating any activities to be performed by the Parties as described
in ARTICLE 5 and ARTICLE 6; and
(d)    coordinating the Parties’ regulatory activities and interactions with
Regulatory Authorities pursuant to ARTICLE 7.
3.2    Composition; Meetings.
(a)    The JZC shall be comprised of senior representatives from each of Aventis
and Regeneron, selected by such Party. The exact number of representatives of
each Party shall be as determined by such Party; provided, however, that neither
Party shall appoint more than three (3) representatives to serve on the JZC. A
Party may change any of its representatives at any time by giving written notice
to the other Party.
(b)    The JZC shall have two co-chairpersons, one designated by each of Aventis
and Regeneron. The co-chairpersons of the JZC shall be: (i) entitled to set
meeting agendas; provided that the agenda shall include any matter reasonably
requested by either Party; and (ii) required to call emergency meetings of the
JZC at the request of a Party. The JZC co-chairpersons shall be responsible for
recording, preparing and, within a reasonable time, issuing minutes of the JZC
meetings, which meeting minutes shall be submitted for approval of the members
of the JZC.
(c)    The JZC shall meet whenever any member of the JZC shall make such a
request in writing to the co-chairpersons; provided, however, that the JZC shall
in no event meet less frequently than every six (6) months. Subject to
appropriate confidentiality undertakings where applicable, additional
participants may be invited by any member of the JZC to attend meetings where
appropriate (e.g., representatives of regulatory affairs or outside
consultants). Such additional participants shall not be deemed to be members of
the JZC, nor shall they have any rights or responsibilities of a member of the
JZC.
(d)    In the event of a dispute within the JZC regarding any matter governed by
the dispute resolution provisions of Sections 5.1, 5.2 or 6.1, either Party may
refer such dispute to the Executive Officers for resolution pursuant to the
provisions of Sections 5.1, 5.2 or 6.1, as applicable.

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3.3    Limitations on Authority. The JZC shall not have the power to amend,
modify or waive compliance with this Agreement, which may only be amended or
modified as provided in Section 20.5 or compliance with which may only be waived
as provided in Section 20.2.
ARTICLE 4
LICENSE GRANTS
4.1    Regeneron License Grants. Subject to the terms and conditions of this
Agreement and any license agreement within the Regeneron Patent Rights,
Regeneron hereby grants to Aventis and its Affiliates the nontransferable
(except as permitted by Section 20.9), exclusive (including with regard to
Regeneron and its Affiliates except as provided in this Section 4.1 and Section
4.2) right and license, with the right to grant sublicenses in accordance with
Section 4.3, under the Regeneron Intellectual Property and Regeneron’s interest
in the Joint Intellectual Property to make, have made, import, use, sell and
offer for sale the Licensed Products solely for use in the Field in the
Territory; provided, however, that Regeneron reserves for itself and its
Affiliates and its and their Third Party licensees the non-exclusive right under
the Regeneron Intellectual Property and Regeneron’s interest in the Joint
Intellectual Property to make, have made and use the Licensed Compound and
Licensed Products for research and development purposes in the Field in the
Territory. For clarity, the foregoing proviso shall not grant Regeneron rights
under the Regeneron Intellectual Property and Regeneron’s interest in the Joint
Intellectual Property to sell or offer for sale the Licensed Products in the
Field in the Territory. The foregoing license grant shall not preclude Regeneron
from, and Regeneron retains all rights with respect to, using or otherwise
exploiting, or granting any Person the right to use or otherwise exploit,
Regeneron Intellectual Property and Regeneron’s interest in the Joint
Intellectual Property for the making, having made, importing, using, selling and
offering for sale (a) the Licensed Compound and Licensed Products solely for use
outside the Field in the Territory and (b) products (other than Licensed
Products) for use with Licensed Products in the Field in the Territory.
4.2    Aventis License Grants. Subject to the terms and conditions of this
Agreement and any license agreement within the Aventis Patent Rights, Aventis
hereby grants to Regeneron and its Affiliates (a) a fully paid-up, royalty-free,
worldwide, exclusive (including with regard to Aventis and its Affiliates) right
and license, with the right to grant sublicenses through multiple tiers, under
the Aventis Intellectual Property and Aventis’ interest in the Joint
Intellectual Property to make, have made, import, use, sell and offer for sale
(i) the Licensed Compound and Licensed Products solely for use in the Excluded
Ocular Field worldwide and (ii) VEGF Products (other than Licensed Products)
worldwide and (b) a fully paid-up, royalty-free, worldwide, non-exclusive right
and license, with the right to grant sublicenses through multiple tiers, under
the Aventis Intellectual Property and Aventis’ interest in the Joint
Intellectual Property to make, have made, import, use, sell and offer for sale
products (other than Licensed Products) for use with Licensed Products in the
Field worldwide. For clarity, clause (b) above does not include the rights to
make, have made, sell or offer for sale Licensed Products in the Field in the
Territory.
4.3    Sublicenses; Subcontracting. Unless otherwise restricted by any Existing
License or New License, the rights granted to Aventis and its Affiliates under
the Regeneron Intellectual

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Property and Regeneron Trademarks are sublicensable with the prior written
consent of Regeneron, which consent shall not be unreasonably withheld,
conditioned or delayed outside of the United States; provided, however, that
nothing shall prevent Aventis from sublicensing its rights to a Distributor to
sell or offer to sell the Licensed Product in the Field in the Territory (other
than the United States). For the avoidance of doubt, Regeneron may withhold such
consent if Regeneron reasonably determines such sublicense would reduce its
financial return from this Agreement in the applicable country. Aventis shall
remain responsible and liable for the compliance by its Affiliates and its and
their permitted sublicensees and Distributors with applicable terms and
obligations set forth herein, including payment under this Agreement and the
Supply Agreement with respect to Net Sales of Licensed Products in the Field by
such Affiliates, sublicensees or Distributors. Aventis agrees that any
sublicense granted pursuant to this ARTICLE 4 or ARTICLE 11 shall be consistent
with, and expressly subject to, the covenants, terms and conditions set forth in
this Agreement. Promptly after entering into any such sublicense, or any
amendment or modification thereto, Aventis will provide a true and correct copy
thereof to Regeneron. Aventis shall also have the right to contract with one or
more Third Parties to perform certain of its obligations under the Plans if
specifically contemplated therein, provided that Aventis shall remain
responsible and liable for the acts and omissions of such Third Party service
providers and such Third Parties undertake in writing obligations of
confidentiality and non-use of New Information and/or Party Information that are
substantially the same as those undertaken by Aventis under this Agreement. In
the event of a breach by a sublicensee, Distributor or a Third Party contractor
of any sublicense or subcontract granted or awarded hereunder by Aventis which
has or is reasonably likely to have a material adverse effect on Regeneron or
the Regeneron Intellectual Property or Regeneron Trademarks, then Regeneron may
cause Aventis to exercise, and Aventis will promptly exercise, any termination
rights it may have under the sublicense or subcontract with such sublicensee,
Distributor or Third Party contractor. All sublicenses and subcontracts granted
under this Agreement will terminate upon termination or expiration of this
Agreement.
4.4    No Implied License. Except as expressly provided herein, neither Party
will be deemed by this Agreement to have been granted any license or other
rights to the other Party’s Patents, Know-How, Party Information or the other
Party’s interest in the Joint Intellectual Property either expressly or by
implication, estoppel or otherwise.
4.5    Technology Transfer. To the extent reasonably necessary for each Party to
exercise its rights and perform its obligations under this Agreement with
respect to the other Party’s intellectual property, and from time to time during
the Term, each Party shall provide to the other Party one (1) copy of books and
records embodying such Party’s applicable intellectual property, to the extent
such books and records may exist or be created in the ordinary course of
business.
4.6    Certain Newly Created Intellectual Property. In addition to the other
licenses granted under this ARTICLE 4 and subject to the other terms and
conditions of this Agreement, to the extent permitted under any relevant Third
Party agreement, each Party hereby 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 through multiple tiers, to use and
practice for any

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and all purposes: (a) all intellectual property (including, without limitation,
Know-How, Patents and Patent applications and copyrights), other than Excluded
Rights, discovered, invented, authored or otherwise created by or on behalf of
such Party, its Affiliates or its or their sublicensees or Distributors (other
than by the other Party or its Affiliates) after January 31, 2006 directly in
connection with the performance of the research activities and/or clinical
development activities under this Agreement, in each case, as included in
Co-Development Plans (as defined in this Agreement prior to the Amendment
Execution Date) or the Development Plan, and (b) the Patents and Know-How
identified on Schedule 2 (which were discovered or otherwise created by
Regeneron (either solely or with Third Party collaborators) directly in
connection with the performance of the Co-Development Plans (as defined in this
Agreement prior to the Amendment Execution Date) prior to January 31, 2006). As
used above, the term “Excluded Rights” shall mean any Patents or Know-How
claiming or covering the composition (including any formulation) of a VEGF
Product, including, without limitation, a VEGF Trap Product. For the avoidance
of doubt, nothing in this Section 4.6 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 or on behalf of such Party, its Affiliates or
its or their sublicensees or Distributors (other than by the other Party or its
Affiliates) outside of the approved research activities and/or clinical
development activities under this Agreement, in each case, as included in
Co-Development Plans (as defined in this Agreement prior to the Amendment
Execution Date) or the Development Plan.
ARTICLE 5
DEVELOPMENT ACTIVITIES
5.1    Development of Licensed Products. After the Amendment Effective Date,
subject to the terms of this Agreement, as between the Parties, Aventis shall be
solely responsible for all aspects of the Development of the Licensed Products
in the Field in the Territory, including all costs and expenses related thereto,
and shall conduct such Development in accordance with the Development Plan.
Without limitation of Section 5.2, Aventis shall (a) use Commercially Reasonable
Efforts to Develop, and obtain and maintain Approvals for, the Licensed Products
in the Field in the Territory and carry out the Development activities assigned
to it in the Development Plan, and (b) conduct all such activities in compliance
with applicable Laws, including, without limitation, Good Practices and export
and import control Laws. Any dispute under this Section 5.1 regarding whether or
not Aventis has used Commercially Reasonable Efforts to Develop, and obtain and
maintain Approvals for, the Licensed Products in the Field in the Territory and
carry out the Development activities assigned to it in the Development Plan
shall be subject to resolution in accordance with Section 10.2.
5.2    Development Plan. Aventis shall provide an initial plan for the
Development of the Licensed Product in the Field in the Territory to Regeneron
(the “Development Plan”), after considering Regeneron’s comments in good faith,
within thirty (30) days after the Amendment Execution Date. The Parties shall
review the Development Plan at least every six (6) months for the purpose of
considering appropriate amendments thereto. In the event that Aventis desires to
amend the Development Plan in the Field, Aventis shall provide the terms of such
proposed amendment to Regeneron in a timely manner prior to implementation of
such amendment for Regeneron’s review and comment. Aventis shall consider
Regeneron’s comments in good faith.

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Aventis shall have final decision-making authority regarding any such proposed
amendment to the Development Plan in the Field, except with respect to
amendments to the Development Plan relating to the conduct of pre-clinical or
non-clinical activities with respect to the Development of the Licensed Products
in the Field in the Territory, which amendments shall require the prior written
consent of Regeneron (not to be unreasonably withheld or delayed).
Notwithstanding the foregoing, Aventis shall not undertake any Development
activities or amend the Development Plan in any way that may be reasonably
expected to have an adverse impact on an Excluded Ocular VEGF Product anywhere
in the world. In the event that (a) Regeneron believes in good faith that the
Development Plan or any such proposed amendment thereto does not constitute
Commercially Reasonable Efforts or otherwise satisfy Aventis’ obligations under
this Agreement with respect to a Licensed Product or (b) Regeneron reasonably
believes in good faith that any Development activities or any proposed amendment
to the Development Plan may be reasonably expected to have an adverse impact on
an Excluded Ocular VEGF Product anywhere in the world, Regeneron shall have the
right to refer any such dispute described in clause (a) for resolution in
accordance with Section 10.2, and any such dispute described in clause (b) for
resolution in accordance with Section 10.3 as promptly as possible, and Aventis
shall refrain from pursuing the disputed activities or amending the Development
Plan during the pendency of any such dispute. Regeneron shall have no obligation
with respect to the Development of (and, except as otherwise provided in this
Agreement, no right to Develop) Licensed Products in the Field in the Territory,
including under the Development Plan, unless and until the Parties agree in
writing as to such Development activities and the associated Regeneron Costs, in
which case Regeneron shall be reimbursed for such Regeneron Costs pursuant to
Section 9.5. The Parties agree that any activities performed by or on behalf of
Regeneron to satisfy the requirements of Regulatory Authorities in connection
with the manufacture of Licensed Products shall be deemed to have been
authorized by Aventis.
5.3    Additional Development Activities. At Aventis’s request, Regeneron shall
continue to provide support with regard to VEGF Trap anti-drug antibody dosing
in biological samples measurement subject to Aventis prior approval of the
associated costs, which costs shall be Regeneron Costs and shall be reimbursed
by Aventis pursuant to Section 9.5; other Development activities may be
performed by Regeneron as discussed and agreed between the Parties.
5.4    Development Reports. Within forty-five (45) days after the end of each
six (6)-month period during which Aventis is conducting Development activities
hereunder, Aventis shall provide to Regeneron a written report (in electronic
form) summarizing the material activities undertaken by Aventis during such six
(6)-month period in connection with the Development Plan, its Development
activities in process and the future activities it expects to initiate during
the following twelve (12)-month period. Each such report shall contain
sufficient detail to enable Regeneron to assess Aventis’ compliance with its
obligations set forth in Section 5.1, including: (i) Aventis’, or its
Affiliates’ or its or their sublicensees’ or Distributors’ activities with
respect to achieving Approvals of Licensed Products in the Territory, (ii)
clinical study results and results of other Development activities, (iii)
communications with Regulatory Authorities with respect to Licensed Products,
and (iv) pharmacovigilance activities. Upon

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reasonable request by Regeneron, the Parties shall meet to review the
information provided in such Development reports.
5.5    Development Records. Aventis shall, and shall cause its Affiliates and
its and their sublicensees and Distributors to, maintain, in good scientific
manner, complete and accurate books and records pertaining to Development of
Licensed Products hereunder, in sufficient detail to verify compliance with its
obligations under this Agreement. Such books and records shall (a) be
appropriate for patent and regulatory purposes, (b) be in compliance with
applicable Law, (c) properly reflect all work done and results achieved in the
performance of its Development activities hereunder, (d) record only such
activities and not include or be commingled with records of activities outside
the scope of this Agreement and (e) be retained by Aventis for at least three
(3) years after the expiration or termination of this Agreement in its entirety
or for such longer period as may be required by applicable Law. Either Party
shall have the right, during normal business hours and upon reasonable notice,
to inspect and copy all such books and records maintained pursuant to this
Section 5.5; provided, however, that the other Party shall maintain such records
and information disclosed therein in confidence in accordance with ARTICLE 16.
5.6    Obligations of The Parties And Their Affiliates. The Parties shall cause
their respective Executive Officers to take the actions and make the decisions
provided under this Agreement to be taken and made by such Executive Officers in
the manner and within the applicable time periods provided under this Agreement
and consistent with the purpose of optimizing the commercial potential of and
financial returns from the Licensed Products consistent with other products at a
similar stage in development or product life and of similar market potential and
without regard to any other pharmaceutical product in development or being
commercialized or sold by or through a Party or any of its Affiliates (the
“Collaboration Purpose”). To the extent a Party performs any of its obligations
under this Agreement or under an Ancillary Agreement 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
or any Ancillary Agreement which restricts or prohibits a Party from taking any
specified action.
ARTICLE 6
COMMERCIALIZATION
6.1    Commercialization of Licensed Products. As between the Parties, Aventis
shall be solely responsible for the Commercialization of the Licensed Products
in the Field in the Territory at Aventis’ sole cost and expense. Without
limitation of Section 6.2, Aventis shall use Commercially Reasonable Efforts to
Commercialize the Licensed Products throughout the Territory. Any dispute under
this Section 6.1 regarding whether or not Aventis has used Commercially
Reasonable Efforts to Commercialize the Licensed Products throughout the
Territory shall be subject to resolution in accordance with Section 10.2.
6.2    Commercialization Plan. The Commercialization of the Licensed Products in
the Field in the Territory shall be conducted pursuant to a comprehensive,
two-year plan (the “Commercialization Plan”). Aventis shall provide the initial
Commercialization Plan within

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thirty (30) days after the Amendment Execution Date. At all times, the
Commercialization Plan shall include, with respect to the Territory generally
and each Major Market Country in the Territory: (i) the general strategies for
the promoting, marketing and distributing the Licensed Products; (ii) pre-launch
Commercialization activities and the expected date of launch; (iii) the nature
of promotional activities anticipated; (iv) any proposed use of Distributors by
Aventis, its Affiliates or sublicensees; (v) non-binding summary sales forecasts
for the Licensed Products; (vi)  plans regarding distribution and supply chain
management; (vii) reimbursement and pricing information; (vii) plans for any
Non-Approval Trials; and (ix) sales force resourcing. At least every six (6)
months, Aventis shall update Regeneron on changes to market conditions impacting
or reasonably expected to impact the Commercialization of one or more Licensed
Products in the Field in the Territory generally or in a Major Market Country in
the Territory and shall propose amendments to the Commercialization Plan to
address any such changes and to otherwise satisfy Aventis’ diligence obligations
set forth in Section 6.1. Aventis shall perform the Commercialization activities
under the Commercialization Plan and shall use Commercially Reasonable Efforts
to do so in accordance with the timelines and so as to achieve the objectives
set forth in the Commercialization Plan. Upon reasonable request by Regeneron,
the Parties shall meet to discuss the Commercialization Plan.
6.3    Commercialization Reports. Within forty-five (45) days after the end of
each six (6)-month period, Aventis shall provide to Regeneron, in electronic
form, with detailed written reports of such Commercialization activities it has
performed, or caused to be performed, since the preceding report and the future
activities it expects to initiate during the following six (6)-month period in
the Major Market Countries. Each such report shall contain sufficient detail to
enable Regeneron to assess Aventis’ compliance with its obligations set forth in
Sections 6.1, 6.2 or 6.7, including, in each case: (i) sales force size and
allocation; (ii) the number and position of details in the applicable period;
(iii) the nature of promotional activities and Licensed Product sampling
activities; (iv) market and sales promotional programs; (v) the conduct of
advertising, public relations and other promotional programs, including
professional symposia and speaker and peer-to-peer activity programs used in the
Commercialization of such Licensed Product; (vi) Net Sales for such Licensed
Product in the Territory; and (vii) any Non-Approval Trials. Upon reasonable
request by Regeneron, the Parties shall meet to review the information provided
in such Commercialization reports.
6.4    Commercialization Records. Aventis shall maintain complete and accurate
books and records pertaining to Commercialization of Licensed Products
hereunder, in sufficient detail to verify compliance with its obligations under
this Agreement and which shall be in compliance with applicable Law and properly
reflect all work done and results achieved in the performance of its
Commercialization activities. Such records related to a Contract Year shall be
retained by Aventis for the longer of (i) the period of time required by
Aventis’ internal records retention policy, (ii) the period of time required by
applicable Law or (iii) two (2) years following the end of such Contract Year.
Regeneron shall have the right (at its cost) during normal business hours and
upon reasonable notice to inspect such books and records pertaining to the two
(2) immediately preceding Contract Years; provided, that the books and records
related to a Contract Year shall not be subjected to such inspection more than
one (1) time unless a material discrepancy or an inconsistency with applicable
Law is found; provided further, that Regeneron

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shall maintain such records and information disclosed therein in confidence
accordance with ARTICLE 16.
6.5    Booking of Sales and Licensed Product Distribution    . Aventis (or its
local Affiliate) shall invoice and book, and appropriately record, all sales by
it or its Affiliate of the Licensed Products in the Territory. Aventis (or its
local Affiliate) shall also be responsible for the distribution of the Licensed
Products in the Field in the Territory and for paying Medicaid and other
governmental rebates that are due and owing with respect to the Licensed
Products distributed by Aventis, its Affiliates or its or their sublicensees or
Distributors in the Territory.
6.6    [****].
6.7    Restrictions on Sales Outside the Field. Aventis shall not, and shall not
permit any of its Affiliates or any of its and their Relevant Licensees, to,
distribute, market, promote, offer for sale or sell the Licensed Products, or
any [****] Product, directly or indirectly (a) to any Person for use outside the
Field or (b) to any Person in the Field that Aventis or any of its Affiliates or
any of its or their Relevant Licensees knows or has reason to know (i) is likely
to distribute, market, promote, offer for sale or sell any Licensed Product or
any [****] Product for use outside the Field or assist another Person to do so
(including any pharmacy, physician, hospital or other entity that is engaged in
any compounding activities related to the Licensed Products or [****] Products),
or (ii) has directly or indirectly distributed, marketed, promoted, offered for
sale or sold any Licensed Product or [****] Product for use outside the Field or
assisted another Person to do so. If Aventis or any of its Affiliates receives
or becomes aware of the receipt by a Relevant Licensee of any orders for any
Licensed Product or [****] Product for use outside the Field, such Person shall
refer such orders to Regeneron. Aventis shall cause its Affiliates and its and
their Relevant Licensees to notify Regeneron of any receipt of any orders for
any Licensed Product or [****] Product for use outside the Field. For the
avoidance of doubt, any development, manufacture or commercialization of any
[****] Product by Aventis or any of its Affiliates or any of its and their
Relevant Licensees shall be pursuant to and in strict accordance with Section
6.11(c). Without limiting the provisions of Section 6.3, Aventis and its
Affiliates shall provide, and shall cause its and their Relevant Licensees to
provide, to Regeneron all necessary information to enable Regeneron to assess
Aventis’ compliance with its obligations set forth in this Section 6.7. For the
purposes of this Section 6.7, “Relevant Licensee” shall mean any (i) Third Party
to whom Aventis or any of its Affiliates have granted a license or sublicense
under rights to the Licensed Products or any [****] Product in the Territory; or
(ii) Distributor or any Third Party acting as a distributor for Aventis or any
of its Affiliates with regard to the Licensed Products or any [****] Product in
the Territory.
6.8    Inventory Management. Aventis shall use Commercially Reasonable Efforts
to manage, or cause to be managed, Licensed Product inventory on hand at
wholesalers and other Distributors or sublicensees (or Affiliates) 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.
6.9    Medical and Consumer Inquiries. Aventis shall have responsibility for
responding to medical questions or inquiries from members of the medical and
paramedical professions and

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consumers regarding Licensed Products in the Field in the Territory. Regeneron
shall refer all such questions about Licensed Products in the Field that it
receives to Aventis.
6.10    Market Exclusivity Extensions. Aventis 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) Aventis has the
exclusive legal right, whether by means of a Patent or through other rights
granted by a Governmental Authority in such country, to market, price and sell a
Licensed Product in such country, and (b) no generic equivalent of a Licensed
Product is marketed in such country. Notwithstanding anything to contrary
contained herein, Aventis shall not be required to extend the period of time
available for market exclusivity described in the immediately preceding sentence
in a given country if (i) Regeneron is supplying Formulated Bulk Product under
the Supply Agreement and (ii) the amounts of Formulated Bulk Licensed Product
supplied by Regeneron would be insufficient to meet the Commercial Supply
Requirements of Licensed Product if such extension of market exclusivity was
obtained; provided, that Aventis notify Regeneron at least thirty (30) days
prior to any relevant deadline or filing date and provide it the right and
opportunity to assume control over such matters and Aventis shall provide any
such assistance in connection therewith as Regeneron may reasonably request.
6.11    Non-Compete; Activities Outside of the Agreement.
(a)    Non-Compete. During the Term, neither Aventis nor its Affiliates or its
or their sublicensees under this Agreement shall, directly or indirectly, either
alone or through any Third Parties, develop, manufacture for use or sale in any
part of the Territory, or commercialize any VEGF Products in the Territory
except for the Licensed Products in the Field pursuant to this Agreement. In the
event that (i) Regeneron terminates this Agreement for any reason or (ii)
Aventis terminates this Agreement for any reason other than pursuant to Section
19.3 or Section 19.5, [****], neither Aventis nor its Affiliates or its or their
sublicensees under this Agreement shall, directly or indirectly, develop,
manufacture or commercialize any VEGF Products in any part of the Territory.
Aventis shall not be considered in breach of this Section 6.11(a) solely by
reason of the acquisition by Aventis of a Person with a VEGF Product if prior to
the closing of such acquisition, Aventis commits in writing to Regeneron that,
promptly following the closing of such acquisition, it will divest itself of the
offending rights and/or activity, and Aventis uses Commercially Reasonable
Efforts to pursue such divestiture, and in the event that such divestiture is
not completed within six (6) months of the closing of such acquisition, Aventis
ceases all development, manufacturing and/or commercialization, as applicable,
of the offending VEGF Product(s). 
(b)    Certain Development Activities Outside of Agreement.
(i)    Notwithstanding anything in this Section 6.11(b) or Section 6.11(a) to
the contrary, Aventis and/or its 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 Aventis’ (or its
Affiliate’s) product, including, but not limited to, Eloxatin® (Oxaliplatin) and
Taxotere®

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(Docetaxel), together with any Third Party VEGF Product that has been granted a
Marketing Approval for at least one indication in the applicable country,
including, but not limited to Avastin® (bevacizumab) (in the United States and
any other country where bevacizumab has been granted a Marketing Approval), in
any oncology indication.
(ii)    Notwithstanding Section 6.11(b)(i), in any indication for which a
Licensed Product Developed under this Agreement has been granted a Marketing
Approval in an applicable country, Aventis must give preference to such Licensed
Product over a Third Party VEGF Product in clinical trials of a VEGF Product for
use in combination with Aventis’ (or its Affiliate’s) product in the same
indication to be studied in the intended clinical trial with the Third Party
VEGF Product.
(iii)    For any combination study with a Third Party VEGF Product covered by
Section 6.11(b)(i) commencing after January 7, 2005, Aventis shall notify
Regeneron prior to initiating such trial, such notice to include a brief
synopsis of the protocol and a description of Aventis’ (or its Affiliate’s)
role(s) and responsibilities in connection with the study. Further, for any
combination study with a Third Party VEGF Product covered by Section 6.11(b)(i),
Aventis shall promptly provide Regeneron with available results of such
combination study, unless such disclosure is prohibited by law or contract.
(iv)    Aventis and/or its Affiliates shall be entitled to use data from
clinical trials permitted by this Section (b)6.11(b) to promote the combination
of Aventis’ product together with such Third Party VEGF Product. For the
avoidance of doubt, Aventis and its respective Affiliates shall use or disclose
Party Information of Regeneron or any of its Affiliates and New Information in
connection with any of the activities described in this Section 6.11(b) only in
accordance with the confidentiality and non-use provisions of ARTICLE 16.
(v)    Notwithstanding anything in this Section 6.11(b) or Section 6.11(a) to
the contrary, Aventis may initiate an Aventis or its Affiliate’s sponsored
pivotal clinical trial in an indication which combines Aventis’ (or its
Affiliate’s) product and a Third Party VEGF Product if, such combination trial
for Approval of Aventis’ (or its Affiliates) product is required in writing by a
Regulatory Authority, and, prior to the commencement of any such clinical trial,
Aventis provides Regeneron with a copy of such written notification, a writing
of the commencement of such clinical trial, and a brief synopsis of the
protocol, including the expected commencement and completion dates.
(c)    Certain Permitted Activities Outside Agreement. Notwithstanding anything
in Section 6.11(a) to the contrary, Aventis (or its Affiliates) may develop and
manufacture for use or sale solely by Aventis (or its Affiliates) and may have
made by a Third Party for use or sale solely by Aventis (or its Affiliates) in
any part of the Territory in the Field a [****] Product outside the scope of
this Agreement, but may only sell the [****] Product so manufactured in any part
of the Territory in compliance with the provisions of the immediately following
sentence. Further, notwithstanding anything in Section 6.11(a) to the contrary,
if Aventis terminates this Agreement with respect to a country (or the entire
Territory) pursuant to Section 19.2, Aventis (or its Affiliates) may
commercialize a [****] Product outside the scope of this Agreement, in such
country (or in the entire Territory if the entire Agreement is terminated) in

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the Field after the first (1st) anniversary of the effective date of such
termination with respect to such country (or the entire Territory). For the
avoidance of doubt, neither Aventis nor its Affiliates nor its or their
sublicenses may develop or commercialize a [****] Product in the Excluded Ocular
Field or manufacture a [****] Product for use or sale in the Excluded Ocular
Field.
(d)    During the Term, neither Regeneron nor its Affiliates or its or their
sublicensees under this Agreement shall, directly or indirectly, either alone or
through any Third Parties, manufacture for sale in any part of the Territory or
commercialize any VEGF Trap Products in the Territory except for the Excluded
Ocular VEGF Products in the Excluded Ocular Field.
6.12    Post Marketing Clinical Trials. Subject to the provision of this
Agreement, Aventis shall use Commercially Reasonable Efforts to comply with any
Clinical Trial obligations with respect to registration Approval with respect to
any Licensed Product in any country in the Territory, imposed by applicable Law
or pursuant to the Approvals or otherwise required by a Regulatory Authority.
ARTICLE 7
REGULATORY AFFAIRS
7.1    Ownership of Approvals and Registration Filings. Aventis shall own all
Approvals and Registration Filings with respect to the Licensed Products in the
Territory and shall have the rights and obligations set forth in Sections 7.2 to
7.8 (inclusive) with respect thereto. Except to the extent prohibited by
applicable Law, Regeneron hereby assigns the Approvals and Registration Filings
listed on Schedule 5 to Aventis or its designated Affiliate (the “Assigned
Regeneron Regulatory Documentation”).
7.2    Rights of Reference.
(a)    Aventis and its Affiliates and licensees shall have, and Regeneron and
its Affiliates hereby grant to Aventis and its Affiliates and licensees, the
right to reference (with the right to grant further rights of reference pursuant
to Section 4.3) all regulatory documentation (including all registration filings
and approvals) Controlled by Regeneron (or its Affiliates) that relate to any
Excluded Ocular VEGF Product as necessary to make, have made, import, use, sell
and offer for sale the Licensed Products in the Field in the Territory. Promptly
upon the request of Aventis, Regeneron or its Affiliate shall submit a letter of
authorization to FDA or the applicable Regulatory Authority (and take such
actions or make such other filings) in order to permit any Excluded Ocular VEGF
Product regulatory documentation (including all registration filings and
approvals) to be incorporated by reference in such Licensed Product regulatory
filings.
(b)    Regeneron and its Affiliates and licensees shall have, and Aventis and
its Affiliates hereby grant to Regeneron and its Affiliates and licensees, the
right to reference (with the right to grant further rights of reference through
multiple tiers) the BLA(s), IND(s), and any Registration Filings and/or
Approvals Controlled by Aventis (or its Affiliates) that relate to any Licensed
Product as necessary to make, have made, import, use, sell and offer for sale
the VEGF Products worldwide outside the Field in the Territory and VEGF Products
(other than Licensed

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Products) and other products for use with Licensed Products in the Field in the
Territory. Promptly upon the request of Regeneron, Aventis or its Affiliates
shall submit a letter of authorization to FDA or the applicable Regulatory
Authority (and take such actions or make such other filings) in order to permit
any Licensed Product IND, BLA, Registration Filing and/or Approval to be
incorporated by reference in such VEGF Product or other product regulatory
filings.
7.3    Regulatory Coordination and Assistance. Subject to the provisions of this
ARTICLE 7, Aventis shall be solely responsible for overseeing, monitoring and
coordinating all regulatory strategy and actions, communications and filings
with and submissions (including supplements and amendments thereto) to each
applicable Regulatory Authority with respect to the Licensed Product in the
Field in the Territory; provided that it shall adhere to the obligations in this
ARTICLE 7. Notwithstanding the foregoing, and without limiting any of
Regeneron’s other rights under this Agreement, Regeneron shall be permitted to
communicate with Regulatory Authorities with regard to the manufacture of
Formulated Bulk Licensed Product at Regeneron under the Supply Agreement in
response to direct inquiry from such Regulatory Authorities. The Parties will
coordinate with regard to such communications.
(a)    Both Parties will cooperate with each other to develop and follow
specific procedures to be agreed upon to coordinate the exchange of necessary
regulatory information from Licensed Products Developed and Commercialized by or
on behalf of Aventis under this Agreement and Excluded Ocular VEGF Products
developed and commercialized by Regeneron and its licensees. For the purpose of
clarity, such regulatory information shall be limited to necessary regulatory
information that could have a material impact on the manufacture, development or
commercialization of the Licensed Products Developed and Commercialized by or on
behalf of Aventis under this Agreement and Excluded Ocular VEGF Products
developed and commercialized by Regeneron and its licensees.
(b)    Regeneron agrees to promptly disclose to Aventis all relevant information
related to Excluded Ocular VEGF Products developed and commercialized by
Regeneron and its licensees that could have a material impact on the
manufacture, development or commercialization of the Licensed Products. Aventis
agrees to promptly disclose to Regeneron all relevant information related to
Licensed Products Developed and Commercialized by or on behalf of Aventis under
this Agreement that could have a material impact on the manufacture, development
or commercialization of the Licensed Products or the Excluded Ocular VEGF
Products. By way of example, categories of information that may have a material
impact on the manufacture, development or commercialization of such products
could include information having implications on safety; clinical; commercial;
regulatory filings or CMC, including CMC issues arising during production or
quality control of the Licensed Compound or EYLEA Drug Substance or in
interactions with Regulatory Authorities regarding CMC issues relevant to both
the Licensed Compound or EYLEA Drug Substance or on any CMC issues relevant to
Formulated Bulk Licensed Product.
(c)    With regard to Licensed Products Developed and Commercialized by or on
behalf of Aventis under this Agreement, Regeneron shall not respond to or
initiate any

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communications, including verbal communications, with Regulatory Authorities or
Governmental Authorities; provided, however, that the foregoing shall not apply
with respect to any direct inquiry from Regulatory Authorities or Governmental
Authorities regarding Licensed Products manufactured by Regeneron or its
Affiliates. With regard to Excluded Ocular VEGF Products developed and
commercialized by Regeneron and its licensees, Aventis shall not respond to or
initiate any communications, including verbal communications, with Regulatory
Authorities or Governmental Authorities.
(d)    The Parties agree to discuss and, if practicable, coordinate with each
other regarding any proposed change controls for any Licensed Compound
manufactured or supplied under the Supply Agreement that will have a material
impact on any Regulatory Filing for any Licensed Product; provided, however,
that Regeneron will consider in good faith any comments provided by Sanofi;
provided, further, that Regeneron will have final decision-making authority with
respect to all change controls.
(e)    The Parties shall work together cooperatively to develop a strategy with
respect to regulatory and chemistry, manufacturing and controls issues common to
both the Licensed Compound and the EYLEA Drug Substance. Notwithstanding the
foregoing, in the event that a Regulatory Authority or Governmental Authority
requests an immediate response from a Party regarding the Licensed Compound or
from Regeneron regarding the EYLEA Drug Substance and such request relates to
regulatory and chemistry, manufacturing and controls issues common to both the
Licensed Compound and the EYLEA Drug Substance, such Party shall use
Commercially Reasonable Efforts to consult with the other Party in advance of
responding to such Regulatory Authority or Governmental Authority, but shall not
be required to delay a response to such request.
(f)    (i) Aventis shall notify Regeneron if any data regarding Licensed
Products generated under this Agreement is submitted to Regulatory Authorities
or Governmental Authorities in support of the Licensed Products to the extent
Aventis determines that such data may reasonably be expected to have an adverse
impact on Excluded Ocular VEGF Products. In the event that Aventis’ regulatory
strategy pertaining to such data may reasonably be expected to have an adverse
impact on Regeneron’s or its (sub)licensees’ regulatory strategy used to support
Excluded Ocular VEGF Products, Regeneron and Aventis shall discuss and agree to
the proposed regulatory strategy pertaining to such data in advance of Aventis’
(or its Affiliates’ or licensees’) communication with Regulatory Authorities or
Governmental Authorities regarding such data. (ii) Regeneron shall notify
Aventis if any data regarding Excluded Ocular Products generated outside of this
Agreement is submitted to Regulatory Authorities or Governmental Authorities in
support of the Excluded Ocular VEGF Products to the extent Regeneron determines
that such data may reasonably be expected to have an adverse impact on Licensed
Products. In the event that Regeneron’s regulatory strategy pertaining to such
data may reasonably be expected to have an adverse impact on Aventis’ or its
(sub)licensees’ regulatory strategy used to support Licensed Products, Regeneron
and Aventis shall discuss and coordinate with each other regarding the proposed
regulatory strategy pertaining to such data in advance of Regeneron’s (or its
Affiliates’ or licensees’) communication with Regulatory Authorities or
Governmental Authorities regarding such data; provided, however, that Regeneron
will consider in good faith any

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comments provided by Sanofi; provided, further, that Regeneron will have final
decision-making authority with respect to all such regulatory strategies and the
final content and position of any such communication with Regulatory Authorities
and Governmental Authorities. Notwithstanding the foregoing, in the event
Regeneron is contractually bound to a third party to maintain confidentiality of
any such data referred to in the foregoing sentence, Regeneron shall use
commercially reasonable efforts to obtain a waiver of confidentiality in order
to provide such data to Aventis in a timely manner.
(g)    (i) Aventis shall use Commercially Reasonable Efforts to provide to
Regeneron within twenty-four (24) hours after receipt by Aventis (or Aventis’
receipt from its Affiliates or licensees) from any Regulatory Authorities or
Governmental Authorities any such information for the Licensed Products that it
determines in good faith is materially relevant to the interests of the Excluded
Ocular VEGF Products, including but not limited to development, regulatory
communications and filings, safety, labeling, manufacturing or product quality
for the Excluded Ocular VEGF Products, or any notice or results of inspections
or manufacturing issues relevant to a VEGF Trap. Regeneron and Aventis shall
discuss and agree on the response to be communicated to Regulatory Authorities
or Governmental Authorities in the Major Market Countries regarding such
information and Aventis shall provide a copy of the response submitted to such
Regulatory Authorities or Governmental Authorities within twenty-four (24) hours
of submission by Aventis (or Aventis’ receipt of such a submission from a
licensee). (ii) Regeneron shall use Commercially Reasonable Efforts to provide
to Aventis within twenty-four (24) hours after receipt by Regeneron (or
Regeneron’s receipt from its’ Affiliates or licensees) from any Regulatory
Authorities or Governmental Authorities any such information for the Excluded
Ocular VEGF Products that it determines in good faith is materially relevant to
the interests of the Licensed Products, including but not limited to
Development, regulatory communications and filings, safety, labeling,
manufacturing or product quality for Licensed Products, or any notice or results
of inspections or manufacturing issues relevant to Excluded Ocular Products.
Regeneron and Aventis shall discuss and agree on the response to be communicated
to Regulatory Authorities or Governmental Authorities regarding such information
and Regeneron shall provide a copy of the response submitted to such Regulatory
Authorities or Governmental Authorities within twenty-four (24) hours of
submission by Regeneron (or Regeneron’s receipt of such a submission from a
licensee). Notwithstanding the foregoing, in the event Regeneron is
contractually bound to a third party to maintain confidentiality regarding any
such information referred to in this Section 7.3(g)(ii), Regeneron shall use
commercially reasonable efforts to obtain a waiver of confidentiality in order
to provide such information to Aventis in a timely manner.
(h)    For purposes of clarification, subject to the provisions of this Section
7.3, Aventis and its licensees will have the sole right to determine the final
content and position of any communication with Regulatory Authorities and
Governmental Authorities with regard to Licensed Products in the Field in the
Territory, provided that Aventis makes a good faith determination that such
communication is not reasonably expected to have an adverse impact on the
development and commercialization of Excluded Ocular VEGF Products in the
Territory.

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(i)    To the extent that EYLEA Drug Substance uses Formulated Bulk Licensed
Product, and Regeneron (i) decides to undertake a modification of EYLEA Drug
Substance for the Excluded Ocular VEGF Product and (ii) the modification will
have a material impact on the regulatory filings of the Licensed Product in the
Field, Regeneron shall notify Aventis thereof and the Parties shall discuss the
regulatory strategy for such EYLEA Drug Substance to the extent relating to such
modification as follows:
(x) in the Major Market Countries, (A) the Parties shall discuss the regulatory
briefing strategy for background materials or submissions related to EYLEA Drug
Substance at least ten (10) days prior to submission to Regulatory Authorities
or Governmental Authorities, (B) Regeneron shall provide to Aventis a copy of
such briefing materials no later than five (5) days prior to submission to a
Regulatory Authority or Governmental Authority, (C) Aventis shall provide any
comments to such briefing materials no later than forty-eight (48) hours
following Regeneron’s provision of such briefing materials, which comments shall
be considered in good faith by Regeneron, and (D) Regeneron shall provide to
Aventis a copy of the final documents; and
(y)
in the non-Major Market Countries, Regeneron shall notify Aventis within
seventy-two (72) hours after Regeneron’s submission (or Regeneron’s receipt of
such a submission from a licensee) of any background materials or submissions
related to EYLEA Drug Substance to any Regulatory Authority or a Governmental
Authority.

Regeneron shall consider Aventis’ comments in good faith. Notwithstanding the
foregoing, should a Regulatory Authority or Governmental Authority request an
immediate response from Regeneron regarding Formulated Bulk Licensed Product,
Regeneron shall use Commercially Reasonable Efforts to consult with Aventis in
advance of a response, but Regeneron will not be required to delay a response to
such request.
7.4    Pharmacovigilance and Safety Data Exchange. Without limiting the
provisions of Section 7.5, the Parties will cooperate with each other to develop
and follow specific procedures to be agreed upon and memorialized in a Safety
Data Exchange Agreement to coordinate the exchange of necessary safety and
pharmacovigilance information from Licensed Products Developed and
Commercialized by or on behalf of Aventis under this Agreement and Excluded
Ocular VEGF Products developed and commercialized by Regeneron and its licensees
to ensure prompt communication of such notifications and compliance with
reporting obligations to Regulatory Authorities.
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,
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. Following receipt of the
inspection or audit observations of the Regulatory Authority (a copy of which
the receiving Party will immediately provide to the other Party), the Party in
receipt of the observations will prepare any appropriate

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responses that concern a Licensed Product, provided that the other Party shall
have the right to review and comment on such responses, except to the extent
such responses contain information for which the Party in receipt of the
observation owes an obligation of confidentiality to a Third Party, and such
Party shall consider in good faith the comments made by such other Party. In the
event that the Parties disagree concerning the form or content of a response,
the Party that received the observations shall 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 twenty-four (24)
hours of receipt of notification from a Regulatory Authority of the intention of
such Regulatory Authority to audit or inspect facilities being used or proposed
to be used for the manufacture of Licensed Products.
7.6    Recalls and Other Corrective Actions. Aventis shall notify Regeneron
promptly (but in no event later than forty-eight (48) hours) following its
determination that any event, incident or circumstance has occurred that may
result in the need for a recall, market suspension or market withdrawal of a
Licensed Product in the Field in the Territory and shall include in such notice
the reasoning behind such determination and any supporting facts. As between the
Parties, Aventis shall have the right to make the final determination whether to
voluntarily implement any such recall, market suspension or market withdrawal in
the Field in the Territory; provided, that prior to any implementation of such a
recall, market suspension or market withdrawal, Aventis shall consult with
Regeneron and shall consider Regeneron’s comments in good faith. If a recall,
market suspension or market withdrawal is mandated by a Regulatory Authority in
the Territory, as between the Parties, Aventis shall initiate such a recall,
market suspension or market withdrawal in compliance with applicable Law. For
all recalls, market suspensions or market withdrawals undertaken pursuant to
this Section 7.6, as between the Parties, Aventis shall be solely responsible
for the execution thereof. Notwithstanding the provisions of this ARTICLE 7 or
ARTICLE 16, Aventis shall provide Regeneron with copies of any proposed
correspondence with Regulatory Authorities or any proposed public announcement,
in each case, related to any voluntary or mandated recall of a Licensed Product
in the Field in the Territory for Regeneron’s review and comment prior to
Aventis making or disclosing any such correspondence or public announcement.
Aventis shall provide Regeneron with copies of any correspondence with
Regulatory Authorities or any public announcement, in each case, related to any
market suspension or market withdrawal of a Licensed Product in the Field in the
Territory.
7.7    Cost of Recalls and Other Corrective Actions. Except as otherwise
provided in ARTICLE 17 , Aventis shall be solely responsible for all costs of a
recall, market withdrawal or other corrective action with respect to any
Licensed Product in the Field in the Territory.
7.8    Licensed Product Labeling. Aventis shall use Commercially Reasonable
Efforts to include language in approved labeling for Licensed Products in the
Field in the Territory stating that the product is not intended for local
administration to the eye.
ARTICLE 8
MANUFACTURING AND SUPPLY

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8.1    Supply Agreement. Simultaneously with execution of this Agreement, the
Parties (or their Affiliates) are amending and restating that certain commercial
supply agreement, dated June 10, 2013, by and between Regeneron and Sanofi
Winthrop Industrie, under which Aventis or its Affiliate shall procure
Formulated Bulk Licensed Products from Regeneron or its Affiliates (the “Supply
Agreement”). Regeneron or its Affiliates shall supply Formulated Bulk Licensed
Product to Aventis (or its Affiliate) under the Supply Agreement pursuant to the
terms thereof until the expiration or termination of the Supply Agreement.
8.2    Aventis Manufacturing and Supply Obligations.
(a)    As between the Parties, Aventis shall be solely responsible, at its sole
cost and expense, for all activities related to finishing, packaging, and
labeling of Finished Licensed Product in the Territory.
(b)    Aventis shall use Commercially Reasonable Efforts to, at its election,
either (a) [****], or (b) otherwise [****], for the manufacture of Formulated
Bulk Licensed Product for the supply of Commercial Supply Requirements and
Clinical Supply Requirements of Licensed Products in the Territory. Without
limiting the foregoing, Regeneron shall, at Aventis’ sole cost and expense, use
Commercially Reasonable Efforts to assist Aventis (or its Affiliate) to, as the
case may be, [****], or [****] for the manufacture of Formulated Bulk Licensed
Product in order to meet Aventis’ obligations under this Section 8.2.
(c)    Aventis may otherwise elect to establish an alternative source, for the
manufacture of Formulated Bulk Licensed Product for the supply of Commercial
Supply Requirements and Clinical Supply Requirements of Licensed Products in the
Territory (x) through one of its other existing manufacturing facilities, (y) by
constructing and obtaining all required approvals and validations by Regulatory
Authorities for a new manufacturing facility or (z) with Regeneron’s prior
consent (which consent shall not be unreasonably withheld, conditioned or
delayed), through a Third Party manufacturer other than [****], in each case
((x), (y) and (z)), at Aventis’ own expense.
(d)    All costs and expenses (including capital expenditures) required to
provide additional manufacturing capacity pursuant to Sections 8.2(b) and
8.2(c), including without limitation the related start-up and validation
activities and the transfer of the manufacturing process for the Licensed
Products from Regeneron (or its Affiliates) to Aventis or a Third Party
manufacturer, shall be paid solely by Aventis.
8.3    Funded Assets. Notwithstanding anything to the contrary in the Funded
Assets MOU, the Parties acknowledge and agree that all title to the Funded
Assets (as defined in the Funded Assets MOU) has transferred to Regeneron and
Regeneron has no further obligations to Aventis or its Affiliates with respect
to the Funded Assets under the Funded Assets MOU.
ARTICLE 9
PAYMENTS
9.1    Payments. Aventis or SWI shall make payments to Regeneron or its
Affiliates under this Agreement and the Supply Agreement pursuant to this
ARTICLE 9.

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9.2    Development Balance; Other Payment Obligations. Notwithstanding anything
to the contrary in this Agreement or the Supply Agreement, the Development
Balance due and owing by Regeneron to Aventis as of the Amendment Effective Date
shall be extinguished and cancelled, without any further act of either Party and
there shall be no further accrual of the Development Balance following the
Amendment Effective Date. Without limiting the foregoing, nothing in this
Agreement shall relieve either Party of any payment obligations arising prior to
the Amendment Effective Date. From and after the Amendment Effective Date,
Aventis shall be solely responsible for all costs and expenses associated with
the Development and Commercialization of the Licensed Products in the Field in
the Territory and Regeneron shall have no obligation to reimburse Aventis for
any costs or expenses incurred by or on behalf of Aventis in connection with the
Development and Commercialization of the Licensed Products in the Territory
after the Amendment Effective Date.
9.3    Net Sales Report. Within twenty (20) days after the end of each Calendar
Quarter, Aventis shall calculate and report to Regeneron the amount of Net
Sales, that are attributable to the Licensed Product in each country in the
Territory during such Calendar Quarter (including such amount expressed in local
currency and as converted into U.S. Dollars in accordance with Section 9.9).
Without limiting the generality of the foregoing, Aventis shall require its
Affiliates and its and their sublicensees and Distributors to calculate and
account for their Net Sales and to provide such reports with respect thereto, in
sufficient detail and at such time so that Aventis can meet its obligations to
Regeneron hereunder if such sales were made by Aventis.
9.4    Third Party Payment Amounts. Aventis shall be solely responsible for
paying all Third Party Payment Amounts, or reimbursing Regeneron on a Calendar
Quarter-by-Calendar Quarter basis pursuant to Section 9.8 for any Third Party
Payment Amount made by Regeneron, in each case pursuant to the terms of this
Section 9.4. Aventis shall, in addition to the Net Sales Report provided
pursuant to Section 9.3, provide Regeneron within forty-five (45) days after the
end of each Calendar Quarter with deductions taken to arrive at Net Sales and
all other information necessary to satisfy Regeneron’s obligations with respect
to any Third Party Payment Amounts under any Existing License or New License to
which Regeneron is a party. Notwithstanding the Genentech Settlement Letter, the
Parties acknowledge and agree that Aventis shall be responsible for making, and
shall make, all payments due under the Genentech Settlement Agreement directly
to Genentech, Inc. (and not to Regeneron pursuant to this Section 9.4).
9.5    Regeneron Costs. Subject to Section 5.2, Aventis shall, on a Calendar
Quarter-by-Calendar Quarter basis pursuant to Section 9.8, reimburse Regeneron
for all of the Regeneron Costs incurred by Regeneron after the Amendment
Effective Date; provided, however, that for any Regeneron Costs incurred by
Regeneron for the benefit of both Licensed Product and any Excluded Ocular VEGF
Product, Aventis shall only be required to reimburse [****] of such Regeneron
Costs. Regeneron shall provide Aventis all such information related to Regeneron
Costs for a Calendar Quarter within forty-five (45) days after the end of each
Calendar Quarter.
9.6    Profit Sharing Payment.

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(a)    The Parties acknowledge and agree that in order to ease the
administrative and accounting burdens on the Parties under this Agreement and to
provide for the commercial supply of Licensed Products, they have elected to
forego the calculation of net profits from sale of Licensed Product and the
sharing of net profits under this Agreement, and the associated reporting,
reimbursement and reconciliation processes, and instead have agreed that Aventis
or SWI shall make payments to Regeneron (or its Affiliate) under this Agreement
and the Supply Agreement based on a simplified profit sharing arrangement
calculated as a percentage of Net Sales, as set forth in this Section 9.6. Such
payments are, in part, intended to reflect the value contributed by Regeneron
with respect to its discovery of the VEGF Trap and the development and
commercialization of the Licensed Products. For clarity, in the event that the
Supply Agreement is terminated for any reason, Aventis shall continue to be
obligated to make payments to Regeneron under this Section 9.6 in accordance
with the terms hereof.
(b)    Aventis shall pay to Regeneron, on a Calendar Quarter-by-Calendar Quarter
basis pursuant to Section 9.8, a percentage of the aggregate Net Sales of all
Licensed Products in the Field in the Territory during each Contract Year (each
such quarterly payment, a “Profit Sharing Payment”), which percentage shall be
based on the aggregate Net Sales of all Licensed Products in the Field in the
Territory during such Contract Year as set forth in the chart below (the
aggregate amount of such payment due with respect to Net Sales in a given
Contract Year, the “Aggregate Profit Sharing Payment”).
Aggregate Net Sales of Licensed Products in the Field in the Territory during
each Contract Year
Percentage of Aggregate Net Sales
Aggregate annual Net Sales of Licensed Products less US$[****]
15%
Aggregate annual Net Sales of Licensed Products equal to or greater than
US$[****] but less than US$ [****]
[****]
Aggregate annual Net Sales of Licensed Products equal to or greater than
US$[****] but less than US$ [****]
[****]
Aggregate annual Net Sales of Licensed Products equal to or greater than
US$[****] but less than US$ [****]
[****]
Aggregate annual Net Sales of Licensed Products equal to or greater than
US$[****]
30%

By way of example, if aggregate Net Sales of all Licensed Products in the Field
in the Territory in a Contract Year are US$ 600,000,000, the Aggregate Profit
Sharing Payment in respect of such Contract Year shall be equal to [****]% Net
Sales of US$ 600,000,000 (i.e., US$ [****]), which example is described in
greater detail in Schedule 10.
(c)    The Profit Sharing Payment due in respect of a given Calendar Quarter
shall be equal to (i) the amount of the Aggregate Profit Sharing Payment owed to
Regeneron with respect to Net Sales in such Contract Year through the end of
such Calendar Quarter

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(“Cumulative Net Sales”), less (ii) the amount of the Aggregate Profit Sharing
Payment, if any, already paid to Regeneron with respect to Cumulative Net Sales
in prior Calendar Quarters of such Contract Year.
9.7    Payments with respect to Batches under the Supply Agreement. Regeneron
shall sell to SWI, and SWI shall purchase from Regeneron, during the Supply
Term, the Product at the following price, payable as follows:
(a)    Regeneron shall invoice SWI for the Estimated Fully Burdened Batch Price
applicable to each Batch that was manufactured and shipped pursuant to a Firm
Order under the Supply Agreement, and SWI shall pay such amount within
forty-five (45) days after the date of such invoice. Beginning in the 2016
Contract Year, within forty-five (45) days after the end of each Calendar
Quarter, Regeneron shall provide a good faith estimate of the Aggregate Actual
Fully Burdened Manufacturing Cost for that Contract Year.
(b)    With respect to Batches to be manufactured in the 2016 Contract Year and
each Contract Year thereafter during the Supply Term, Regeneron shall provide in
writing to SWI by [****] Regeneron’s good faith estimate of the Actual Fully
Burdened Manufacturing Costs of any Batch to be manufactured in such Contract
Year, which estimate shall be based on the Actual Fully Burdened Manufacturing
Cost of prior years, current year-to-date manufacturing costs, the number of
Batches expected to be manufactured in such Contract Year, and any other
relevant factors (the “Estimated Fully Burdened Batch Price”). The Estimated
Fully Burdened Batch Prices for the 2014 Contract Year and the 2015 Contract
Year are set forth in Appendix 1.
(c)    Beginning with Product manufactured in the 2016 Contract Year, clauses
(i), (ii) and (iii) of this Section 9.7(c) shall apply:
(i)    Within sixty (60) days after the end of each Contract Year during the
Supply Term, Regeneron shall calculate and provide SWI with (A) (1) the total
Actual Fully Burdened Manufacturing Cost for all quantities of Product
manufactured during such Contract Year pursuant to a Firm Order, [****], and the
cost of any Batches that were [****], and (2) amounts due to Regeneron in
respect of quantities of Product in respect of a Firm Order which [****] (the
sum of (1) and (2) the “Aggregate Actual Fully Burdened Manufacturing Cost”),
(B) the total amount of the payments based on the Estimated Fully Burdened Batch
Price for such Contract Year that have been invoiced to SWI (the “Payment
Total”), which shall equal the product of (x) the number of Batches that were
manufactured during such Contract Year [****] (the “Batch Number”), and (y) the
Estimated Fully Burdened Batch Price for such Contract Year, and (C) the amount
equal to the difference between the Aggregate Actual Fully Burdened
Manufacturing Costs and the Payment Total (the “Reconciliation Amount”). In the
event that, with respect to a Contract Year, the Aggregate Actual Fully Burdened
Manufacturing Cost is greater than the Payment Total, then Regeneron shall
invoice SWI for the Reconciliation Amount. In the event that, with respect to a
Contract Year, the Payment Total is greater than the Aggregate Actual Fully
Burdened Manufacturing Cost, then SWI shall invoice Regeneron for the
Reconciliation Amount. Any invoice prepared pursuant to the foregoing two
sentences will be prepared by the appropriate Party within ten (10) days of
receipt by SWI of the report containing the Reconciliation Amount. The Party
receiving an invoice pursuant to the foregoing three

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sentences shall pay the Reconciliation Amount within thirty (30) days after the
date of such invoice.
(ii)    With regard to Batches manufactured in any given Contract Year within
the Supply term, which [****], Regeneron shall invoice SWI for their Actual
Fully Burdened Manufacturing Cost and SWI shall pay such amount within
forty-five (45) days after the date of such invoice.
(iii)    For clarity, with respect to any Batches manufactured in a given
Contract Year but shipped after the end of such Contract Year, Regeneron shall
invoice SWI, in accordance with Section 9.7(a) and pursuant to Section 9.8, the
amount of the Estimated Fully Burdened Batch Price in effect during the Contract
Year in which such Batch was manufactured, regardless of whether a
Reconciliation Payment was made by either Party under this Section 9.7(c). To
the extent any Batches manufactured in a given Contract Year are shipped after
[****], (i) Regeneron shall invoice SWI for their Estimated Fully Burdened
Manufacturing Cost, (ii) SWI shall pay such amount within forty-five (45) days
after the date of such invoice and (iii) any Reconciliation Amount payable on
such batches shall be carried forward to the reconciliation for the subsequent
year and added to the Reconciliation Amount to be calculated for such year
pursuant to Section 9.7(c)(i). For further clarity, in no event shall this
Section 9.7(c) diminish Aventis’s obligations to provide Firm Orders pursuant to
Section 5.1 of the Supply Agreement.
9.8    Quarterly Invoicing and Payment. Following the end of each Calendar
Quarter, within fifteen (15) days after receipt by Regeneron of the Net Sales
Report from Aventis pursuant to Section 9.4, Regeneron shall invoice Aventis the
following amounts due for such Calendar Quarter: (i) all Third Party Payment
Amounts due in respect of such Calendar Quarter pursuant to Section 9.4, (ii)
the amount of Regeneron Costs incurred by Regeneron in such Calendar Quarter
which are due pursuant to Section 9.5, and (iii) the amount of the Profit
Sharing Payment due with respect to such Calendar Quarter pursuant to Section
9.6 and in accordance with the form of calculation set forth on Schedule 10.
Aventis shall pay the amount due to Regeneron pursuant to such invoice(s) within
twenty five (25) days after receipt by Aventis of such invoice(s). For clarity,
the receipt date shall be the date any invoice is electronically received by
Aventis.
9.9    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
U.S. Dollars using the spot rates the average of the daily spot rates fixed by
the European Central Bank from the last Business Day of the preceding month, as
published on the website located on the following URL:
http://sdw.ecb.europa.eu/browseSelection.do?DATASET=0&sfl1=4&FREQ=M&sfl3=4&CURRENCY=USD&node=2018794.
In the event of a payment dispute under this ARTICLE 9, the disputing Party
shall be required to pay all non-disputed amounts pursuant to the terms of
ARTICLE 9 and may withhold the payment only of any disputed amounts and only
during the pendency of any such dispute.

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9.10    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. Unless otherwise mutually agreed by
the Parties or otherwise provided in this Agreement, all 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 one month London Inter-Bank Offering
Rate (LIBOR) U.S. Dollars, as quoted on Thomson Reuters Eikon (or any other
source agreed to by the Parties) effective for the date on which the payment was
due, [****] (such sum being referred to as the “Default Interest Rate”).
9.11    Taxes. 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 or the Ancillary
Agreements, 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 furnish the other Party with proper
evidence 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).
All amounts due under this ARTICLE 9 are exclusive of sales, use, goods and
services, value added, excise, and other taxes, duties or charges of a similar
nature imposed by any Governmental Authority, or other taxing authority. If any
sales, use, goods and services, value added, excise, and other taxes, duties or
charges of a similar nature will be chargeable with respect to payments made
under this ARTICLE 9, Aventis shall pay to, or upon receipt of invoice from
Regeneron, shall reimburse, Regeneron these in addition to the sums otherwise
payable, at the rate in force at the due time for payment or such other time as
is stipulated under the relevant legislation.
ARTICLE 10
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 to use all reasonable efforts to
facilitate the resolution of such disputes in an expedient manner by mutual
agreement.
10.2    Legal Disputes. The Parties agree that, subject to Sections 10.4 and
16.4, they shall use all reasonable efforts to resolve any Legal Dispute arising
under this Agreement by good faith negotiation and discussion. In the event that
the Parties are unable to resolve any such Legal Dispute either Party may submit
the Legal Dispute to the Executive Officers for resolution, specifying the
nature of the Legal 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 Legal Dispute
within thirty (30) days of receiving such written notification. Any final
decision mutually agreed to by the Executive Officers shall be conclusive and
binding on the Parties. In the event the Executive Officers are unable to
resolve

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any such Legal Dispute, the Parties shall be free to pursue any rights and
remedies available to them at law, in equity or otherwise.
10.3    Escalation to Executive Officers. In the event of a dispute between the
Parties with respect to any Development activities or any proposed amendment to
the Development Plan pursuant to Section 5.2, either Party may, on written
notice to the other Party, refer such dispute to the Executive Officers for a
joint decision, 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. Any
final decision mutually agreed to by the Executive Officers shall be conclusive
and binding on the Parties. In the event that the Executive Officers are unable
during such thirty (30)-day period to resolve a dispute between the Parties with
respect to whether or not any Development activities or any proposed amendment
to the Development Plan may be reasonably expected to have an adverse impact on
an Excluded Ocular VEGF Product anywhere in the world, Regeneron’s Executive
Officer shall have final decision-making authority. In the event that the
Executive Officers are unable during such thirty (30)-day period to resolve a
dispute between the Parties with respect to any Development activities or any
proposed amendment to the Development Plan other than a dispute with respect to
whether or not any Development activity or proposed amendment to the Development
Plan may be reasonably expected to have an adverse impact on an Exclude Ocular
VEGF Product anywhere in the world, Aventis’ Executive Officer shall have the
final decision-making authority.
10.4    No Waiver. Nothing in this ARTICLE 10 shall prohibit either Party from
seeking immediate injunctive or other equitable relief if such Party reasonably
believes that it will suffer irreparable harm from the actions of the other.
ARTICLE 11
TRADEMARKS AND CORPORATE LOGOS
11.1    Corporate Logos. 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. As between the Parties, Aventis shall
have the sole right to select one or more Product Trademarks (including back-up
trademarks) for each Licensed Product for use with respect to such Licensed
Product.
11.3    Ownership of Product Trademarks. Unless otherwise mutually agreed
between the Parties, (a) Regeneron (or its local Affiliates, as appropriate)
shall own and retain all right, title and interest in and to Product
Trademark(s) for the Licensed Products, together with all associated trade
dress, trade names, services marks, .us domain names and all associated social
media identifiers and accounts for the Licensed Products and the Regeneron
Licensed Product Domain Names, in the United States, and all goodwill related
thereto (the “Regeneron Trademarks”), and (b) Aventis (or its local Affiliates,
as appropriate) shall own and retain all right, title and interest in and to
Product Trademark(s) for the Licensed Products, together with all associated
trade dress, trade names, services marks, gTLD and ccTLD (other than .us domain
name) for the Licensed Products, in all countries in the Territory other than
the United States and all goodwill related thereto (the “Aventis Trademarks”).

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11.4    Prosecution and Maintenance of Product Trademarks. Aventis will use
Commercially Reasonable Efforts to register, and to prosecute and maintain any
registration and registration application for, the Aventis Trademarks for the
Licensed Products in all countries in the Territory other than the United
States, and Aventis will use Commercially Reasonable Efforts to register, and to
prosecute and maintain any registration and registration application for, the
Regeneron Trademarks for the Licensed Products in Regeneron’s name in the United
States. Notwithstanding the foregoing, in the event Aventis elects not to
register, or to prosecute or maintain any registration or registration
application for, any Aventis Trademark or any Regeneron Trademark for the
Licensed Products in the Territory, Regeneron shall have the right to do so on
behalf of Aventis for use with the Licensed Products in the Field during the
Term, subject to consultation and cooperation with Aventis. The Parties agree
that Aventis shall be solely responsible for [****] costs and expenses incurred
in connection with the prosecution and maintenance of the Aventis Trademarks and
the Regeneron Trademarks during the Term, except in the event that Regeneron
elects to assume responsibility for the prosecution and maintenance of any
Aventis Trademark or Regeneron Trademark, in which case Regeneron shall bear
[****] of all costs and expenses incurred in prosecuting and maintaining such
Aventis Trademark or Regeneron Trademark.
11.5    License to the Licensed Product Trademarks. Regeneron hereby grants to
Aventis a license to use the Regeneron Trademarks to manufacture, Develop and
Commercialize the Licensed Products in the Territory pursuant to this Agreement
and subject to the terms and conditions of this Agreement. Aventis’ rights under
this Section 11.5 may be sublicensed, but only to its Affiliates and permitted
sublicensees and Distributors pursuant to the terms of Section 4.3 for the
purposes of, and subject to the terms and conditions of, this Agreement. Except
as provided in this Agreement, neither Party shall have rights in or to the
other Party’s Product Trademarks or the goodwill pertaining thereto. Aventis
shall utilize the Regeneron Trademarks only on approved Promotional Materials or
other approved product-related materials for the Licensed Products for the
purposes contemplated herein. All use by Aventis or its Affiliates or permitted
sublicensees or Distributors of the Regeneron Trademark(s) shall be in
accordance with such quality standards and trademark usage guidelines
established by Regeneron that it deems reasonably necessary to preserve its
rights in, and the validity and enforceability of, the Regeneron Trademark(s),
including any registration and registration application therefor, and the
goodwill therein, and which Regeneron may modify and supplement from time to
time upon written notice thereof to Aventis, and all goodwill generated through
such use shall inure to the sole benefit of Regeneron for the purposes of
trademark and trade name ownership, registration, enforcement and maintenance.
Each Party agrees that at no time during the Term will it or any of its
Affiliates attempt to use or register any trademark, trade dress, service mark,
trade name or domain name or social media identifier that is confusingly similar
to, misleading or deceptive with respect to the other Party’s Product
Trademark(s) for the Licensed Products or take any action or do any act that
endangers, damages, dilutes, destroys or similarly affects, in any material
respect, the other Party’s trademark or the value of the goodwill pertaining
thereto or attack, dispute or contest the validity of or ownership of the other
Party’s Product Trademark(s) or any registrations or pending registration
thereof. Aventis agrees that upon termination or expiration of the Term, it will
discontinue forthwith all use of the Regeneron Trademark. Upon request by
Aventis, Regeneron shall (or shall cause its Affiliates, as appropriate, to)
execute such

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documents as may reasonably be required for the purpose of recording with any
Governmental Authority the license referred to above in this Section 11.5.
11.6    Use of Corporate Names.
(a)    Aventis shall not use Regeneron’s or its Affiliates’ corporate names or
logos on any Promotional Materials related to the Licensed Products (including,
without limitation, congress booths or Promotional Materials used or distributed
in connection with the applicable Licensed Product) in the Field or otherwise in
the Territory; provided, however, that Aventis shall (i) be permitted to
identify Regeneron (or its Affiliate) as the manufacturer of the Licensed
Products in any such materials to the extent required under any applicable Law
and for so long as Regeneron or its Affiliate is supplying Licensed Products to
Aventis or its Affiliates under the Supply Agreement and (ii) use Commercially
Reasonable Efforts to include in any such materials the phrase “ZALTRAP was
developed in collaboration with Regeneron Pharmaceuticals, Inc.” or similar
language to the extent permitted under any applicable Law, in each case ((i) and
(ii)), consistent with the provisions of Section 11.5.
(b)    Accordingly, unless Regeneron has terminated this Agreement pursuant to
Sections 19.3, 19.4, 19.5 or 19.6 or Aventis has terminated this Agreement
pursuant to Section 19.2, Regeneron hereby grants to Aventis (and its
Affiliates) a non-exclusive license, with the right to grant sublicenses in
accordance with Section 4.3, to use Regeneron’s corporate names or logos solely
as provided in this Section 11.6 during the Term and thereafter for a maximum
period of two (2) years solely to the extent necessary to exhaust the existing
inventory of Licensed Product and such materials containing Regeneron’s
corporate names or logos. Without limiting the foregoing, Aventis shall not and
shall not permit its Affiliates or its or their sublicensees or Distributors to,
(m) use in their respective businesses, any trademark that is confusingly
similar to, misleading or deceptive with respect to or that dilutes any (or any
part) of Regeneron’s corporate names or logos, (n) take any action or do any act
that endangers, damages, dilutes, destroys or similarly affects, in any material
respect, Regeneron’s corporate names or logos or the value of goodwill
pertaining thereto, or (o) attack, dispute or contest the validity of or
ownership of Regeneron’s corporate names or logos anywhere in the Territory or
any registrations or any pending registration thereof. Aventis agrees and shall
cause its Affiliates and its and their sublicensees or Distributors, to conform
(y) to the customary industry standards for the protection of the trademarks and
to such trademark usage guidelines as Regeneron may furnish from time to time
with respect to the use of Regeneron’s corporate names or logos and (z) to
adhere to and maintain the highest quality standards of Regeneron with respect
to goods sold and services provided under Regeneron’s corporate names or logos.
ARTICLE 12
NEWLY CREATED INVENTIONS
12.1    Ownership of Newly Created Intellectual Property.
(a)    Each Party shall exclusively own all right, title and interest in and to
any and all intellectual property (including, without limitation, Know-How,
Patents and copyrights) discovered, invented, authored or otherwise created
under or in connection with this Agreement solely by or on behalf of such Party,
its Affiliates or its or their sublicensees or Distributors

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(other than by the other Party or its Affiliates) (“Sole Inventions”). Sole
Inventions made solely by or on behalf of Aventis, its Affiliates or its or
their sublicensees or Distributors (other than Regeneron and its Affiliates) are
referred to herein as “Aventis Sole Inventions.” Sole Inventions made solely by
or on behalf of Regeneron, its Affiliates or its or their sublicensees or
Distributors (other than Aventis and its Affiliates) 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 each own an equal, undivided interest in any and all
intellectual property (including, without limitation, Know-How, Patents and
copyrights) discovered, invented, authored or otherwise created under or in
connection with this Agreement during the Term jointly by or on behalf of
Aventis, its Affiliates or its or their sublicensees or Distributors, on the one
hand, and Regeneron, its Affiliates or its or their sublicensees or
Distributors, on the other hand (“Joint Inventions”). Each Party shall disclose
to the other Party in writing and shall cause its Affiliates, and its and their
sublicensees and Distributors to so disclose, the conception, discovery,
invention or reduction to practice of any Joint Invention.
(c)    Notwithstanding the foregoing in Section 12.1(b), (i) for purposes of
determining whether a patentable invention is an Aventis 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 Aventis 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 an Aventis 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 vests in a Party, by operation of Law or otherwise, in a manner
contrary to the agreed upon ownership as set forth in this Agreement, such Party
shall, and hereby does, irrevocably assign, and shall cause its Affiliates and
its and their sublicensees and Distributors to so 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 is
governed by the terms and conditions of this Agreement, including the terms of
ARTICLE 4, as follows: each Party’s interest in the Joint Inventions may be
sublicensed, and any ownership rights therein transferred, in whole or in part,
by each Party without consent of the other Party, provided that 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 the other terms of this Agreement that
relate to the Joint Inventions; provided, further, that nothing in this ARTICLE
12 shall relieve a Party or its Affiliates of their

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obligations under ARTICLE 16 with respect to New Information or confidential
Party Information provided by or on behalf of the other Party or such other
Party’s Affiliates. Except as otherwise provided in this Agreement with respect
to the Licensed Products, neither Party hereto shall have the duty 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. 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 Patents.
(a)    Regeneron shall use Commercially Reasonable Efforts to prepare, file,
prosecute and maintain the Regeneron Patent Rights throughout the Territory, and
shall confer with and keep Aventis 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 the Regeneron Patent
Rights: (i) Regeneron shall use Commercially Reasonable Efforts to provide to
Aventis for review and comment 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 Regeneron and consider in good faith any
comment; (ii) Regeneron shall notify Aventis prior to the filing of a Patent
Application by Regeneron; (iii) Regeneron shall consult with Aventis following
the filing of the priority Patent application in sufficient time to permit the
Parties to mutually determine in which countries it shall file convention Patent
applications; (iv) Regeneron shall provide Aventis promptly with copies of all
communications received from or filed in patent offices with respect to such
filings; and (v) Regeneron shall provide Aventis a reasonable time prior to
taking or failing to take action that would affect the scope or validity of
rights under any Regeneron Patent Rights (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 Aventis has a reasonable
opportunity to review and make comments, and take such actions as may be
appropriate in the circumstances. In the event that Regeneron desires to abandon
any Regeneron Patent Rights, Regeneron shall provide reasonable prior written
notice to Aventis 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 Right with the
applicable patent office) and Aventis shall have the right, but not the
obligation, to assume responsibility for the prosecution and maintenance thereof
in Regeneron’s name, unless, with respect to any such Patent applications that
are unpublished, Regeneron notifies Aventis that Regeneron would prefer to
maintain the subject matter of such Patent application as a trade secret.
(b)    Aventis shall use Commercially Reasonable Efforts to prepare, file,
prosecute and maintain the Aventis Patent Rights throughout the Territory, and
shall confer with and keep Regeneron reasonably informed regarding the status of
such activities. In addition, Aventis shall have the following obligations with
respect to the filing, prosecution and maintenance of the Aventis Patent Rights:
(i) Aventis shall use Commercially Reasonable Efforts to provide to Regeneron
for review and comment a copy of a substantially completed draft of

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any priority Patent application at least thirty (30) days prior to the filing of
any such priority Patent application by Aventis and consider in good faith any
comment; (ii) Aventis shall notify Regeneron prior to the filing of a Patent
application by Aventis; (iii) Aventis shall consult with Regeneron following the
filing of the priority Patent application in sufficient time to permit the
Parties to mutually determine in which countries it shall file convention Patent
applications; (iv) Aventis shall provide Regeneron promptly with copies of all
communications received from or filed in patent offices with respect to such
filings; and (v) Aventis shall provide Regeneron a reasonable time prior to
taking or failing to take action that would affect the scope or validity of
rights under any Aventis Patent Rights (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 it has a reasonable
opportunity to review and make comments, and take such actions as may be
appropriate in the circumstances. In the event that Aventis desires to abandon
any Patent included in the Aventis Patent Rights, Aventis 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 Aventis
Patent Right 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 Aventis’ name, unless, with respect to any such Patent
applications that are unpublished, Aventis notifies Regeneron that Aventis would
prefer to maintain the subject matter of such Patent application as a trade
secret.
(c)    The Parties shall consult with each other regarding the filing,
prosecution and maintenance of any Joint Patent Rights, 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. The Controlling Party shall have the
following obligations with respect to the filing, prosecution and maintenance of
the Joint Patent Rights: (i) the Controlling Party shall use Commercially
Reasonable Efforts to provide any priority Patent application at least thirty
(30) days prior to the filing of any such priority Patent application by the
Controlling Party and consider in good faith any comment from the
non-Controlling Party; (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 following the filing of the priority Patent application in
sufficient time to permit the Parties to mutually determine in which countries
it shall file convention Patent applications; (iv) the Controlling Party shall
provide the non-Controlling Party promptly with copies of all communications
received from or filed in patent offices with respect to such filings; 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 Joint Patent Rights (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-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

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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 ninety (90) days of a written request by the
non-Controlling Party to do so, 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 (and will undertake such filings, prosecutions and
maintenance in such Party’s name). Notwithstanding the foregoing, the
Controlling Party may withdraw from or abandon any Joint Patent Rights on thirty
(30) days’ prior notice to the other Party, providing the non-Controlling Party
the right to assume the prosecution or maintenance thereof in such
non-Controlling Party’s name and cost and expense.
(d)    All Out-of-Pocket Costs incurred in the filing, prosecution and
maintenance of any Aventis Patent Rights, Regeneron Patent Rights and Joint
Patent Rights, and any extensions thereof pursuant to Section 12.2(e)(e), shall
be [****], except to the extent that the prosecuting Party elects to abandon the
applicable Aventis Patent Right, Regeneron Patent Right or Joint Patent Right,
in which case the other Party shall bear [****] of such Out-of-Pocket Costs if
such other Party elects to assume responsibility for the prosecution and
maintenance thereof as provided herein.
(e)    Each Party agrees to cooperate with the other with respect to the
preparation, filing, prosecution and maintenance of the Regeneron Patent Rights,
Aventis Patent Rights and Joint Patent Rights 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 Parties
shall cooperate to determine for which of the Aventis Patent Rights, Regeneron
Patent Rights and Joint Patent Rights to seek an extension of the term in the
Territory.

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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, post-grant review, reissue or reexamination
relating to Regeneron Patent Rights, Aventis 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. Decisions
on whether to initiate such 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 Aventis,
(ii) with respect to Aventis Patent Rights, by Aventis 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, post-grant review, reissue, or reexamination proceeding relating to
the Regeneron Patent Rights, Aventis Patent Rights and/or Joint Patent Rights
shall be [****].
ARTICLE 13
INTELLECTUAL PROPERTY LITIGATION
13.1    Enforcement of Patents and Product Trademarks.
(a)    In the event that either Party or any of its Affiliates becomes aware of
an actual or suspected infringement or unauthorized use, as applicable, of a
Aventis Patent Right, a Regeneron Patent Right, a Joint Patent Right or any
Product Trademark, in each case, by a Third Party’s activities in the Territory
(an “Infringement”), the Party that became aware of the Infringement shall
promptly notify the other Party in writing and shall provide such other Party
with all available evidence supporting such Infringement. As soon as reasonably
practicable after the receipt of such notice, the Parties shall meet and
consider the appropriate course of action with respect to such infringement.
(b)    With respect to any Infringement, (i) Regeneron shall have the first
right to bring and control any action or proceeding with respect to Infringement
of any Regeneron Patent Right or of any Joint Patent Right that [****], and (ii)
Aventis shall have the first right to bring and control any action or proceeding
with respect to Infringement of any Aventis Patent Right or Joint Patent Right
other than a Joint Patent Right that [****] (the Party with the first right
being referred to as the “Lead Litigation Party”); provided, however, that the
Parties shall ensure that there is proper communication and coordination of
activities between the Parties. If the Lead Litigation Party fails to bring any
such action or proceeding with respect to Infringement of the applicable Patent
by a Third Party within sixty (60) days following notice of the alleged
infringement (or such other period of time as may be required by applicable
Law), the non-Lead Litigation Party shall have the right to bring and control
any such action at its own expense by providing written notice to the other
Party (the Party who controls the litigation to be referred to as the
“Litigation Party”). The non-Litigation Party will provide reasonable assistance
to the Litigation Party in prosecuting any action, and if required by Law, will
join in the action. Although the 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.

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The non-Litigation Party shall have the right to (and, if required by Law, will)
join in any litigation using counsel of its choice at its sole discretion and
expense, subject to Section 13.1(c). The amount of any recovery from any such
Infringement action shall be (i) retained [****] and (ii) [****], provided that
any such recoveries shall be first allocated to [****]. Notwithstanding the
foregoing, any recoveries for lost sales or lost profits of a product for any
Infringement hereunder shall be (A) with respect [****] and (B) with respect to
[****].
(c)    All Out-of-Pocket Costs (except for the expenses of the non-Litigation
Party’s counsel, if any) incurred in connection with any Infringement litigation
under Section 13.1(b) shall be (i) borne [****], (ii) borne [****], (iii)
[****], and (iv) to the extent not otherwise covered in clauses (i) - (iii),
borne [****].
(d)    For the avoidance of doubt, neither Party will enter into any settlement
of any Infringement suit referenced in this Section 13.1 involving Licensed
Products that materially adversely affects the other Party’s rights or
obligations with respect to the applicable Licensed Product (with respect to
Regeneron as the settling party) or the VEGF Products (with respect to Aventis
as the settling party), as applicable in the Territory without the other Party’s
prior written consent.
13.2    Patent Marking. Aventis shall comply with the patent marking statutes in
each county in which a Licensed Product is made, offered for sale, sold or
imported by such Party, its Affiliates and/or its or their sublicensees or
Distributors.
13.3    Third-Party Infringement Claims.
(a)    If either Party or its Affiliates becomes aware of a claim or assertion
that the manufacture, Development or Commercialization of any Licensed Product
in the Field infringes or otherwise violates the intellectual property rights of
any Third Party in the Territory such Party shall promptly notify the other
Party in writing of this claim or assertion. As soon as reasonably practicable
after the receipt of such notice, the Parties shall meet and consider the
appropriate course of action with respect to such allegation of infringement.
(b)    The Parties shall 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, with respect to material court filings and
the defense and/or settlement of any such claim; provided, however, that each
Party shall have the right to defend and control the defense of any such action
naming it as a defendant at its sole cost and expense, using counsel of its own
choice; provided further that any counterclaim or defense alleging Infringement
(or infringement) shall be governed by Section 13.1. 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 alleging that the manufacture,
Development or Commercialization of any Licensed Product in the Field infringes
or otherwise violates the intellectual property rights of such Third Party in
the Territory.
(c)    Unless otherwise agreed by the Parties, each Party shall bear its own
Out-of-Pocket Costs and internal costs (except for the expenses of the
non-controlling Party’s

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cooperation pursuant to Section 13.3(b), if only one Party defends a claim)
incurred in connection with any litigation under this Section 13.3.
(d)    For the avoidance of doubt, neither Party will enter into any settlement
of any suit involving Licensed Products that materially adversely affects the
other Party’s rights or obligations with respect to the applicable Licensed
Product (with respect to Regeneron as the settling party) or the VEGF Products
(with respect to Aventis as the settling party), as applicable in the Territory
without the other Party’s prior written consent.
13.4    Invalidity or Unenforceability Defenses or Actions.
(a)    In the event that a Third Party asserts, as a defense or as a
counterclaim in any Infringement action (or infringement action) under Section
13.1, that any Regeneron Patent Rights, Aventis Patent Rights or Joint Patent
Rights are invalid or unenforceable, then the Party first becoming aware of such
claim shall promptly give written notice to the other Party. Subject to the
assistance and coordination provisions described in Section 13.1(b), the
Litigation Party shall have the final decision-making authority on responding to
such defense or defending against such counterclaim (as applicable), including
the right to settle or otherwise compromise such claim, in consultation with the
non-Litigation Party.
(b)    If a Third Party asserts, in a declaratory judgment action or similar
action or claim filed by such Third Party, that any Regeneron Patent Rights,
Aventis Patent Rights or Joint Patent Rights are invalid or unenforceable, then
the Party first becoming aware of such action or claim shall promptly give
written notice to the other Party. The Party having the final decision-making
authority on controlling the defense of such action or claim, including
settlement negotiations and terms, will be (i) with respect to Regeneron Patent
Rights, Regeneron in consultation with Aventis, (ii) with respect to Aventis
Patent Rights, Aventis in consultation with Regeneron, and (iii) with respect to
Joint Patent Rights, the Parties jointly. Any such Party controlling the defense
against any such action or claim shall use legal counsel mutually agreeable by
the Parties, and 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.
(c)    All Out-of-Pocket Costs incurred in connection with responding to or
defending against any action or claim that any Regeneron Patent Rights, Aventis
Patent Rights or Joint Patent Rights are invalid or unenforceable pursuant to
this Section 13.4 shall be borne in the same manner as set forth in Section
13.1(c) with respect to the allocation of costs for Infringement litigation.
(d)    For the avoidance of doubt, neither Party will enter into any settlement
of any suit referenced in this Section 13.4 that materially adversely affects
the other Party’s rights or obligations with respect to Licensed Products (with
respect to Regeneron as the settling party) or the VEGF Products (with respect
to Aventis as the settling party), as applicable in the

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Territory, including admitting the invalidity or unenforceability of any
Regeneron Patent Rights, Aventis Patent Rights, or Joint Patent Rights, without
the other Party’s prior written consent.
ARTICLE 14
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 or the Supply 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 or the Supply
Agreement and discuss the affairs, finances and accounts of such Party or such
Affiliate to the extent relating to this Agreement or the Supply 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 costs), 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 any calendar year, to have the books and records of the other
Party and its Affiliates to the extent relating to this Agreement or the Supply
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
under this Agreement or the Supply 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 receipt thereof. Unless otherwise mutually agreed by
the Parties, any disputes regarding the results of any such audit shall be
subject to the dispute resolution procedures set forth in Section 10.2. If the
audited Party or its Affiliates have underpaid or over billed an amount due
under this Agreement or the Supply Agreement resulting in a cumulative
discrepancy during any year of more than ten percent (10%), 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 or the Supply Agreement, and shall be subject to the
confidentiality provisions contained in ARTICLE 16.
(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

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contested pursuant to Section 14.2(b) above, the Party (or its Affiliate) 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
(or its Affiliate) entitled thereto within thirty (30) days after receipt of the
written results of such audit pursuant to this Section 14.2.
14.3    GAAP/IAS/IFRS. Except as otherwise provided herein, all costs and
expenses and other financial determinations with respect to this Agreement or
the Supply Agreement shall be determined in accordance with GAAP or IAS/IFRS as
generally and consistently applied.
ARTICLE 15
REPRESENTATIONS AND WARRANTIES
15.1    Due Organization, Valid Existence and Due Authorization. Each Party
hereto represents and warrants to the other Party, as of the Amendment Execution
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; (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 granting, the licenses granted to the
other under ARTICLE 4 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.
15.2    Knowledge of Pending or Threatened Litigation. Each Party represents and
warrants to the other Party that, as of the Amendment Execution 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 entity 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    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 VEGF PRODUCT.
EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT

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LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE.
ARTICLE 16
CONFIDENTIALITY
16.1    Confidential Information. Each of Aventis and Regeneron acknowledges
(subject to Section 16.2 and ARTICLE 19) 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 is confidential and
proprietary to such other Party or its respective Affiliates. Furthermore, each
of Aventis and Regeneron acknowledges (subject to the further provisions of this
ARTICLE 16) that all New Information is confidential and proprietary to both
Parties (and both Parties shall be deemed to be the receiving Party with respect
thereto). During the Term and for a period of ten (10) years thereafter, each of
Aventis and Regeneron shall, and shall cause its officers, directors, employees
and agents to, maintain in confidence and not disclose to any Third Party or not
use the Party Information of the other Party (or its Affiliates) and all New
Information, except to the extent such disclosure or use is expressly permitted
by the terms of this Agreement.
16.2    Exclusions. Notwithstanding anything provided above, the confidentiality
and non-use restrictions provided in this ARTICLE 16 shall not apply to Party
Information or New Information that was or is (and such information shall not be
considered confidential or proprietary under this Agreement):
(a)    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 provided such information;
(b)    already in the possession of the receiving Party or its Affiliate at the
time of disclosure by the disclosing Party; provided, however, that this
exception shall not apply with respect to New Information;
(c)    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; or
(d)     similar in nature to the purported Party Information or New Information
but has been independently created outside of this Agreement, as evidenced by
written or electronic documentation, without any aid application or use of the
Party Information or New Information.
16.3    Permitted Disclosures and Uses.
(a)    Each Party may use or disclose Party Information of the other Party and
New Information to the extent that such use or disclosure is:

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(i)    necessary or useful to file, prosecute, enforce or defend Patents or
Patent applications for which the Party has the right to assume filing,
prosecution, enforcement, defense or maintenance pursuant to this Agreement;
provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information to the extent practicable and
consistent with applicable Law;
(ii)    required by a Governmental Authority, applicable Law (including the
rules and regulations of any stock exchange or trading market on which the
receiving 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, 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 that is required by a
Governmental Authority, applicable Law or court order to be disclosed;
(iii)    used to enforce the terms of this Agreement or any Ancillary 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; or
(iv)    to the Regulatory Authorities as required in connection with obtaining
or maintaining any application of a Licensed Product in the Field in the
Territory pursuant to the terms of this Agreement; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information to the extent practicable and consistent with applicable Law.
(b)    Notwithstanding anything provided above or elsewhere in this Agreement,
Regeneron and its Affiliates shall have the right to use and disclose any New
Information or Party Information of Aventis, in each case, related to Excluded
Ocular VEGF Products and VEGF Products (including the making or use thereof):
(i)    in connection with Regeneron’s discovery, development, manufacture or
commercialization of VEGF Products (other than a Licensed Product in the Field)
in the Territory, including, without limitation, to existing or potential
distributors, (sub)licensees, Affiliates or collaboration partners or otherwise
in connection with the performance of its obligations or exercise of Regeneron’s
rights as contemplated by this Agreement; or
(ii)    to the Regulatory Authorities as required in connection with obtaining
or maintaining any application of a VEGF Product (other than a Licensed Product
in the Field) in the Territory; provided, however, that reasonable measures
shall be taken to assure confidential treatment of such information to the
extent practicable and consistent with applicable Law.

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(c)    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 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.
16.4    Injunctive Relief. Each Party acknowledges that damages resulting from
breach of this ARTICLE 16 would be an inadequate remedy and that,
notwithstanding the provisions of ARTICLE 10, in the event of any such
disclosure or use or any indication of an intent to disclose or use Party
Information or New Information, the Party (or its Affiliates) owning such Party
Information or New Information shall be entitled to seek, by way of private
litigation, injunctive relief, whether preliminary or permanent, specific
performance and other equitable relief, including an equitable accounting of all
earnings, profits and other benefits arising from such breach, which rights
shall be cumulative and in addition to any other rights or remedies to which
such non-breaching Party may be entitled in law or equity and reasonable
attorneys’ fees. In any such action for equitable relief in a court of competent
jurisdiction, both Parties agree to waive any requirement that the other (a)
post a bond or other security as a condition for obtaining any such relief and
(b) show irreparable harm, balancing of harms, consideration of the public
interest or inadequacy of monetary damages as a remedy.
16.5    Publication of New Information. During the Term, if either Aventis or
Regeneron (the “Publishing Party”) desires to disclose any New Information or
Party Information of the other Party that relates to any Licensed Product in
scientific journals, publications or scientific presentations or otherwise, 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 or such Party Information of the other Party prior to submission for
publication or disclosure. Such other Party shall have a reasonable opportunity
to recommend any changes it reasonably believes are necessary (a) to preserve
the New Information or such other Party Information or (b) to enable the Parties
to obtain patent protection if either Party deems it necessary), and the
Publishing Party shall not unreasonably reject such comments and, if requested
by the other Party, shall delay or prevent such disclosure or publication as
reasonably proposed by such 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.
16.6    Other Publications. During the Term, in the event that Aventis or
Regeneron desires to issue any other press releases or public announcements
concerning this Agreement or any Ancillary Agreement or any other activities
contemplated thereunder, in each case, to the extent not otherwise addressed in
Section 16.5, except as prohibited by a Governmental Authority or applicable
Law, such Party agrees to provide to the other Party a copy of any public
announcement, as soon as reasonably practicable (which, except under
extraordinary circumstances, shall be at least five (5) Business Days) prior to
its scheduled release; provided,

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however, that, without prior submission to the other Party, either Party may
issue press releases or public announcements that incorporate information
concerning this Agreement or any Ancillary Agreement or any activities
contemplated thereunder which information was included in a press release or
public announcement which was previously approved by the other Party as part of
a press release or other public disclosure concerning this Agreement or which
contains only non-material factual (non-financial) information regarding this
Agreement (e.g., that the Agreement remains in effect). Except as otherwise
required by applicable Law, the Party whose press release has been reviewed
shall remove any information the reviewing Party reasonably deems to be
inappropriate for disclosure. In connection with any press release or other
written public announcement issued by Aventis pursuant to this Section 16.6,
Aventis shall use Commercially Reasonable Efforts to include in any such press
release or public announcement the phrase “ZALTRAP was developed in
collaboration with Regeneron Pharmaceuticals, Inc.” or similar language to the
extent permitted under any applicable Law, consistent with the provisions of
Section 11.5. Except as required by Law, 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 16 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 at least
equivalent in scope to those included herein. In furtherance of the foregoing
provisions of this Section 16.6, each Party shall give the other Party a
reasonable opportunity to review all filings of this Agreement and all filings
describing the terms of this Agreement with any Governmental Authority,
including without limitation the United States Securities and Exchange
Commission, prior to submission of such filings, and shall give due
consideration to any reasonable comments by the non-filing Party relating to
such filing, including without limitation the provisions of this Agreement for
which confidential treatment should be sought.
ARTICLE 17
INDEMNITY
17.1    Indemnity and Insurance.
(a)    Aventis will defend, indemnify and hold harmless Regeneron, its
Affiliates and its and their respective officers, directors, employees,
(sub)licensees, distributors 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 a Third Party’s claim, action, suit, judgment or
settlement (a “Third Party Claim”) against a Regeneron Indemnitee that is due to
or based upon:
(i)    the negligence, recklessness, bad faith, intentional wrongful acts or
omissions of Aventis or its Affiliates (or, to the extent permitted under this
Agreement, their respective agents, contractors, sublicensees, Distributors,
representatives or other persons or entities working on their behalf) in the
performance of this Agreement, including, without limitation, in connection with
its Development, Commercialization, or manufacture of any Licensed Product;

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(ii)    material breach by Aventis (or conduct or omission by any of its
Affiliates, which if performed or failed to be performed by Aventis would be a
material breach by Aventis) of the terms of, or the representations and
warranties made by it in, this Agreement or any applicable Ancillary Agreement
to which it is a party; or
(iii)    the exploitation of the Licensed Products, including any actions or
omissions by Aventis or its Affiliates (or, to the extent permitted under this
Agreement, their respective agents, contractors, sublicensees, Distributors,
representatives or other persons or entities working on their behalf) in
connection therewith, except in each case ((i), (ii) and (iii), 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, to the
extent permitted under this Agreement, their respective agents, contractors,
sublicensees, distributors, representatives or other persons or entities working
on their behalf) in the performance of this Agreement or the material breach by
Regeneron (or conduct or omission by any of its Affiliates, which if performed
or failed to be performed by Regeneron would be a material breach by Regeneron)
of the terms of the Supply Agreement.
(b)    Regeneron will defend, indemnify and hold harmless Aventis, its
Affiliates and its and their respective officers, directors, employees,
sublicensees, Distributors and agents (“Aventis Indemnitees”) from and against
all Damages arising from a Third Party Claim against a Aventis Indemnitee that
is due to or based upon:
(i)    the negligence, recklessness, bad faith, intentional wrongful acts or
omissions of Regeneron or its Affiliates (or, to the extent permitted under this
Agreement, their respective agents, contractors, sublicensees, distributors,
representatives or other persons or entities working on their behalf),
including, without limitation, in connection with the development or
commercialization of any Licensed Product; provided, however, that Regeneron’s
indemnification obligations with respect to the manufacture of Licensed Products
shall be governed by the terms of the Supply Agreement; or
(ii)    material breach by Regeneron (or conduct or omission by any of its
Affiliates, which if performed or failed to be performed by Regeneron would be a
material breach by Regeneron) of the terms of, or the representations and
warranties made by it in, this Agreement (other than ARTICLE 8, which shall be
governed by and subject to the limitations set forth in the Supply Agreement),
except in each case ((i) and (ii), to the extent that Damages arise out of the
negligence, recklessness, bad faith or intentional wrongful acts, or omissions
committed by Aventis or its Affiliates (or, to the extent permitted under this
Agreement, their respective agents, contractors, sublicensees, Distributors,
representatives or other persons or entities working on their behalf) in the
performance of this Agreement.
(c)    Aventis 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, commercial general liability and product liability
insurance in an amount not less than Ten Million Dollars ($10,000,000) per
occurrence and in the annual aggregate. Such

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insurance shall insure against liability arising from this Agreement on the part
of Aventis and any of its Affiliates, due to injury, disability or death of any
person or persons, or property damage.
17.2    Indemnity Procedure.
(a)    The Party entitled to indemnification under this ARTICLE 17 (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.
(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
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 to be 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 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
and the Indemnified Party.

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(iii)    Regardless of whether the Indemnifying Party assumes the defense of any
claim pursuant to this Section 17.2, the Indemnified Party shall and shall cause
each indemnitee to, cooperate in the defense or prosecution thereof and shall
furnish such records, information and testimony, provide such witnesses and
attend such conferences, discovery proceedings, hearings, trials and appeals as
may be reasonably requested in connection therewith. Such cooperation shall
include access during normal business hours afforded to the Indemnifying Party
to and reasonable retention by the Indemnified Party of, records and information
that are reasonably relevant to such claim and making Indemnified Parties and
other employees and agents available on a mutually convenient basis to provide
additional information and explanation of any material provided hereunder, and
to the extent the Indemnified Party is entitled to indemnification pursuant to
this ARTICLE 17, the Indemnifying Party shall reimburse the Indemnified Party
for all its reasonable and verifiable out-of-pocket expenses in connection with
providing such assistance.
ARTICLE 18
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 or any Ancillary
Agreement for failure or delay in fulfilling or performing any term of this
Agreement or any Ancillary 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 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 19
TERM AND TERMINATION
19.1    Term/Expiration of Term.
(a)    The “Term” of this Agreement shall commence on the Effective Date and end
at such time as neither Aventis, nor any of its Affiliates or its or their
sublicensees or Distributors, is Developing or Commercializing any Licensed
Product in the Field anywhere in the Territory (and such cessation of
Development and Commercialization activities is acknowledged by both Parties to
be permanent), unless earlier terminated as provided hereafter.
(b)    Upon expiration of the Term, except as set forth in this Agreement
(including Sections 19.7 and 19.8), all licenses and rights granted by a Party
to the other Party hereunder shall automatically terminate and revert to the
granting Party.
19.2    Termination Without Cause. Aventis may terminate this Agreement (a) on a
country-by-country basis for all Licensed Products in such country on [****]
prior written notice to Regeneron or (b) with respect to the entire Territory
for all Licensed Products on [****] prior written notice to Regeneron; provided,
however, that any termination of this Agreement in five

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(5) or more of the Original Major Market Countries shall be treated as a
termination of this Agreement in its entirety under clause (b). Except as
otherwise provided below in this Section 19.2, the Agreement shall continue in
full force and effect through the notice period set forth above (the
“Termination Notice Period”). During the Termination Notice Period, to the
extent set forth or requested in one or more written notices from Regeneron to
Aventis hereunder (y) such licenses and rights granted to Aventis shall
automatically terminate as of a date specified in such notice(s) (but not later
than the Termination Notice Period) in the Terminated Territory and (z) Aventis
will promptly take the actions required by Schedule 6 or Schedule 7, as
applicable, and Regeneron will reasonably cooperate with Aventis (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 Termination Notice Period, with as little
disruption as reasonably possible, of the continued Development and/or
Commercialization of such Licensed Product(s) in the Terminated Territory.
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 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 (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 diligent 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 lime as the breaching party ceases to use diligent 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
second sentence of this Section 19.3 shall instead be thirty (30) days (and the
immediately following parenthetical clause in such sentence shall not apply).
For purposes of this Section 19.3, the term “material breach” shall mean a
breach by a Party that substantially undermines the benefits reasonably expected
to be realized by the non-breaching Party from the Collaboration, taken as a
whole.
19.4    Termination for Aventis’ Material Breach of the Supply Agreement. In the
event that Regeneron (or its Affiliate) terminates the Supply Agreement for
Aventis’ (or its Affiliate’s) material breach thereof, Regeneron shall have the
right to terminate this Agreement in its entirety upon thirty (30) days’ prior
written notice to Aventis.
19.5    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) the other Party proposes a written agreement of

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composition or extension of its debts, or (c) 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) 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.
19.6    Termination for Breach of Investor Agreement. Notwithstanding anything
to the contrary herein, Regeneron will have the unilateral right to terminate
this Agreement in its entirety, upon written notice to Aventis, if any of the
Standstill Parties (as defined in the Amended and Restated Investor Agreement,
dated as of January 11, 2014 (the “Investor Agreement”), by and among Aventis,
sanofi-aventis US LLC, Aventis, sanofi-aventis Amérique du Nord and Regeneron)
shall have breached Section 4.1 of the Investor Agreement. For the avoidance of
doubt, Regeneron shall not have the right to terminate this Agreement as a
result of a de minimis breach of Section 4.1(a) of the Investor Agreement or an
inadvertent breach of Section 4.1(g) of the Investor Agreement 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 Section 4.1 of the Investor
Agreement.
19.7    Effect of Termination/Expiration.
(a)    Upon termination of this Agreement in its entirety pursuant to Section
19.2(b), 19.3, 19.4, 19.5 or 19.6, the provisions of Schedule 6 shall apply, and
except to the extent required by Aventis to fulfill its obligations pursuant to
Schedule 6 (and upon the earlier of such fulfillment or written notice from
Regeneron that it will not require such fulfillment, such licenses and rights,
to the extent not previously terminated, shall automatically terminate and
revert to Regeneron), (i) all licenses and rights granted by Regeneron to
Aventis hereunder shall automatically terminate and revert to Regeneron, and
(ii) the licenses from Aventis and its Affiliates to Regeneron referred to in
Schedule 6 shall come into full force and effect.
(b)    Upon termination of this Agreement with respect to a Terminated Territory
pursuant to Section 19.2(a) (but not in the case of any termination of this
Agreement in its entirety), the provisions of Schedule 7 shall apply with
respect to the Terminated Territory, and except to the extent required by
Aventis to fulfill its obligations pursuant to Schedule 7 (and upon the earlier
of such fulfillment or written notice from Regeneron that it will not require
such fulfillment, such licenses and rights, to the extent not previously
terminated, shall automatically terminate and revert to Regeneron), (i) all
licenses and rights granted by Regeneron to Aventis hereunder with respect to
the Terminated Territory shall automatically terminate and revert to Regeneron,
and (ii) the licenses from Aventis and its Affiliates to Regeneron referred to
in Schedule 7 with respect to the Terminated Territory shall come into full
force and effect. Without limiting the foregoing, in the event that Aventis
terminates this Agreement with respect to a Terminated Territory pursuant to
Section 19.2(a), Regeneron shall not take any action with respect to the
Development and Commercialization of the Licensed Product(s) in the Field in the
Terminated Territory that could reasonably be expected to have a materially
adverse impact on

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Aventis’ continued Development and Commercialization of the Licensed Product(s)
in the Field in the Territory.
(c)    Without limiting Section 19.8, upon termination of this Agreement, the
following provisions of this Agreement shall survive the termination of this
Agreement and shall continue to be enforceable: ARTICLE 12 and ARTICLE 13,
provided that, with respect to all the countries of the world in the case of
termination under Section 19.7(a), and with respect to the Terminated Territory
in the case of termination under Section 19.7(b), (i) Regeneron shall have the
first right, but not the obligation, to enforce the Aventis Patent Rights in the
territory to which such termination applies pursuant to Section 13.1(b); (ii)
any costs and expenses incurred in connection with the prosecution and
maintenance (including any interference, opposition or reexamination) of the
Regeneron Patent Rights, Aventis Patent Rights or Joint Patent Rights in the
territory to which such termination applies, or the defense of any claim that
any of the foregoing are invalid or unenforceable (excluding the cost of any
counsel employed by the non-controlling Party) shall be treated as follows: (1)
with respect to the Regeneron Patent Rights and Aventis Patent Rights, the Party
controlling the prosecution, maintenance or defense of such Regeneron Patent
Rights or Aventis Patent Rights shall be responsible for such costs, except in
the event that Regeneron elects to assume responsibility for the prosecution and
maintenance of the Aventis Patent Rights pursuant to Section 12.2(b), in which
case Regeneron shall be responsible for the costs incurred by Regeneron in
connection therewith, and (2) with respect to the Joint Patent Rights, the
Parties shall [****]; and (iii) any costs and expenses incurred in connection
with the enforcement (and any resulting recoveries) of the Regeneron Patent
Rights, Aventis Patent Rights or Joint Patent Rights in the territory to which
such termination applies shall be the responsibility of the enforcing Party and
the enforcing Party shall retain all recoveries with respect thereto; provided,
however, that notwithstanding anything to the contrary in this Section 19.7(c),
any recoveries for lost sales or profits of a product from any Infringement
action hereunder shall be paid solely to or retained solely by the Party that is
selling (or has the right to sell) such product.
19.8    Survival of Obligations. Except as otherwise provided in this ARTICLE
19, Schedule 6 or Schedule 7, upon expiration or termination of this Agreement,
the rights and obligations of the Parties hereunder shall terminate to the
extent of such expiration or termination, and this Agreement shall cease to be
of further force or effect to the extent of such expiration or termination,
provided that notwithstanding any expiration or termination of this Agreement:
(a)    neither Aventis nor Regeneron shall be relieved of any obligations
(including payment obligations) of such Party arising prior to such expiration
or termination, including, without limitation, with respect to Aventis, 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 in the case of termination of this Agreement
pursuant to Section 19.2, without limitation of and subject to Aventis’
continuing obligations under the provisions referred to in Section 19.2,
Aventis’ other obligations hereunder shall terminate prior to expiration of the
Termination Notice Period if prior to such expiration Regeneron enters into a
collaboration agreement of substantially similar scope as, and providing

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for the assumption and performance by the counterparty thereto of the
obligations of Aventis under, this Agreement;
(b)    subject to the provisions of this ARTICLE 19 (including Schedule 6 and
Schedule 7 to the extent applicable), the following obligations shall survive
the expiration or termination of this Agreement and shall continue to be
enforceable: Sections 4.6, 5.5, 6.4, 6.7, 6.10, 6.11, 7.2 (solely with respect
to Regeneron and, insofar as necessary to fulfill its ongoing regulatory
obligations, Aventis), 7.3(f) and (g) (solely with respect to Aventis’
obligations with respect to Excluded Ocular VEGF Products), 7.4, 7.5, 7.6 (first
sentence), 7.7, 8.3, 11.1, 11.3(a), 11.5 (penultimate sentence), 11.6, 15.3,
19.1, 19.2, 19.7 (including Schedule 6 and Schedule 7), 19.8 and ARTICLE 9,
ARTICLE 12 and 13 (subject to Section 19.7(c)), ARTICLE 14, ARTICLE 17, and
ARTICLE 20 to the extent applicable.
(c)    such expiration or termination and this ARTICLE 19 shall be without
prejudice to any rights or remedies a party may have for breach of this
Agreement, including, without limitation, any breach of the provisions referred
to in clause (b) above; and
(d)    if this Agreement is terminated with respect to the Terminated Territory
pursuant to Section 19.2(a) (but not in its entirety), then following such
termination the foregoing provisions set forth in this Section 19.8 shall remain
in effect with respect to the Terminated Territory (to the extent they would
survive and apply in the event this Agreement expires or is terminated in its
entirety) and all provisions not surviving in accordance with the foregoing
shall terminate upon termination of this Agreement with respect to the
Terminated Territory and be of no further force and effect (and for the
avoidance of doubt all provisions of this Agreement shall remain in effect with
respect to all countries in the Territory other than the Terminated Territory).
ARTICLE 20
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,
excluding any conflicts or choice of law rule or principle that might otherwise
refer construction or interpretation of this Agreement to the substantive law of
another jurisdiction. Each Party hereby irrevocably and unconditionally consents
to the exclusive jurisdiction of the courts of the State of New York, and the
United States District Court for the Southern District of New York for any
action, suit or proceeding (other than appeals therefrom) arising out of or
relating to this Agreement, waives any objections to such jurisdiction and venue
and agrees not to commence any action, suit or proceeding relating to this
Agreement except in such courts. Each Party further agrees that service of any
process, summons, notice or document by registered mail to its address set forth
in Section 20.3 shall be effective service of process for any action, suit or
proceeding brought against it under this Agreement in any such court.
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

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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 hereunder or
in connection herewith shall be in writing, shall be sent to the address of the
relevant Party set forth on Schedule 8 attached hereto and shall be (a)
delivered personally, (b) sent by registered or certified mail, return receipt
requested, postage prepaid, (c) sent via a reputable nationwide overnight
courier service, or (d) 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, three (3) Business Days after
it is sent by registered or certified mail, return receipt requested, postage
prepaid, one (1) Business Day 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 Ancillary Agreements
to the extent referred to herein 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.
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 Aventis and Regeneron.
20.6    Headings. The descriptive headings of Articles and Sections are inserted
solely for convenience of reference and are not intended as complete or accurate
descriptions of the content of such Articles or Sections.
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, further 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 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 16.6
above. The other Party shall promptly cooperate in such filing or

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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 Aventis or Regeneron without (a) the prior written consent of Regeneron
in the case of any assignment by Aventis or (b) the prior written consent of
Aventis in the case of an assignment by Regeneron, except in each case (i) to an
Affiliate of the assigning Party, provided that the assigning Party shall remain
primarily liable hereunder notwithstanding any such assignment, or (ii) subject
to Section 19.6, 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 Aventis Indemnitees to the extent provided in the last sentence
of Section 20.13.
20.11    Affiliates. Each Party may perform its obligations hereunder through
one or more of its Affiliates, although each Party shall nonetheless be
responsible for the performance of its Affiliates. Neither Party shall permit
any of its Affiliates to commit any act (including any act or omission) which
such Party is prohibited hereunder from committing directly.
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. This Agreement may be executed by exchange between the
Parties of electronically transmitted signatures (via facsimile, PDF format via
e-mail or other electronic means) and such signatures shall be deemed to bind
each Party hereto as if they were original signatures.
20.13    Third-Party Beneficiaries. Except as provided below in this Section
20.13, 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 17 is intended to benefit, and to be enforceable by, in
addition to the Parties, the other Regeneron Indemnitees and Aventis Indemnitees
as if they were parties hereto.
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 except as expressly provided in this Agreement. Neither
Aventis 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

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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 Aventis, and Aventis’ legal relationship under this Agreement to
Regeneron, shall be that of 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 AVENTIS BE LIABLE
FOR SPECIAL, 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, EXCEPT TO THE
EXTENT ANY SUCH DAMAGES ARE PAID TO A THIRD PARTY AS PART OF A THIRD-PARTY CLAIM
WHICH IS COVERED BY THE INDEMNIFICATION OBLIGATIONS IN ARTICLE 17.
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 employees from the other Party involved in the manufacture, Development or
Commercialization of any VEGF 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    Rejection of Agreement in Bankruptcy. All rights and licenses granted
under or pursuant to this Agreement by a 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 that all intellectual property rights
licensed under or pursuant to this Agreement, 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 (35A) of the Bankruptcy Code subject to the protections
afforded the non-rejecting Party under Section 365(n) of the Bankruptcy Code,
and any similar law or regulation in any other country. The Parties agree that
this Agreement shall not be deemed terminated by virtue of any rejection by a
Party or its receiver or trustee under applicable bankruptcy Laws unless the
non-rejecting Party fails to exercise its rights under Section 365(n)(1)(B) of
the U.S. Bankruptcy Code (or its foreign equivalents). For clarity, if the
non-rejecting Party fails to exercise such rights or such rights are not
available in a country outside the United States, this Agreement shall be deemed
terminated. The Parties further agree that, in the event of the commencement of
a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy
Code or any analogous Laws in any other country or jurisdiction, if this
Agreement is not terminated or deemed terminated, the Party hereto that is not
the subject of such proceeding shall be entitled to a complete duplicate of (or

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complete access to, as appropriate) all such intellectual property and all
embodiments of such intellectual property, which, if not already in such Party’s
possession, shall be promptly delivered to it upon such Party’s written request,
unless the Party subject to such proceeding elects to continue to perform all of
its obligations under this Agreement.
20.18    Construction.
(a)    The use of words in the singular or plural, or with a particular gender,
shall not limit the scope or exclude the application of any provision of this
Agreement to such person or persons or circumstances as the context otherwise
permits. The words “will” and “shall” shall have the same meaning and the use of
the word “or” is used in the inclusive sense (and/or). The term “including,”
“include,” or “includes” as used herein shall mean including, without limiting
the generality of any description preceding such term, irrespective of whether
such term is used with “without limitation” or “without limiting” throughout
this Agreement. Whenever this Agreement refers to a number of days, unless
otherwise specified, such number refers to calendar days.
(b)    The captions of this Agreement are for convenience or reference only and
in no way define, describe, extend or limit the scope of intent of this
Agreement or in the intent of any provision contained in this Agreement. Unless
otherwise specified, (i) the references in this Agreement to any Article,
Section, Schedule or Appendix means references to such Article, Section,
Schedule or Appendix of this Agreement, (ii) references in any section to any
clause are references to such clause of such section and (iii) references to any
agreement, instrument or other document in this Agreement refer to such
agreement, instrument or other document as originally executed or, if
subsequently varied, replaced or supplemented from time to time, so varied,
replaced or supplemented and in effect at the relevant time of reference
thereto.
(c)    Whenever a provision of this Agreement requires an approval or consent by
a Party to this Agreement and notification of such approval or consent is not
delivered within the applicable time limit, then, unless otherwise specified,
the Party whose approval or consent is required shall be conclusively deemed to
have withheld its approval or consent. This Agreement has been prepared jointly
and the provisions contained herein shall not be construed or interpreted for or
against any Party to this Agreement because such Party drafted or caused such
Party’s legal representative to draft any provision contained herein.
(d)    In the event of any conflict between this Agreement and the Schedules and
Appendices hereto, this Agreement shall prevail. In the event of any conflict
between this Agreement and the Supply Agreement, this Agreement shall control.

[SIGNATURE PAGE FOLLOWS.]
    

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

SANOFI-AVENTIS US, LLC
 
 
By
/s/ Robert DeBerardine
 
Name: Robert DeBerardine
 
Title: General Counsel, Sanofi North America
 
 
REGENERON PHARMACEUTICALS, INC.
 
 
By
/s/ Murray A. Goldberg
 
Name: Murray A. Goldberg
 
Title: Senior Vice President

SIGNATURE PAGE TO LICENSE AGREEMENT

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SCHEDULE 1
Existing Licenses

[****]

[****]

[****]

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

SCHEDULE 2
Certain Newly Created Intellectual Property
[****]

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

SCHEDULE 5
Assigned Regeneron Regulatory Documentation
None

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SCHEDULE 6
Transition Arrangements Following Termination in its Entirety
1.    Aventis shall promptly collect and return, and cause its Affiliates and
its and their sublicensees and Distributors to collect and return, to Regeneron
or, at Regeneron’s request, destroy, all documents containing Party Information
or New Information directly relating to the Licensed Products, and shall
immediately cease, and cause its Affiliates and its and their sublicensees and
Distributors to cease, all further use of any such Party Information or New
Information with respect to such Licensed Products. In addition, at Regeneron’s
request, Aventis shall collect and transfer to Regeneron any remaining inventory
of Promotional Materials, product samples, and Licensed Product inventory.
Notwithstanding the foregoing in this Schedule 6, Aventis 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.
Regeneron shall be entitled to use and disclose any such information (including
any such Party Information and/or New Information) in connection with the
manufacture, Development or Commercialization of Licensed Products.
2.    Aventis 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 and/or Commercialization of the Licensed Products. 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 when, if and as requested by
Regeneron:
(a)    Aventis shall grant, and does hereby grant, to Regeneron a fully paid-up,
royalty-free, exclusive license (which shall include the right to grant
sublicenses through multiple tiers) from Aventis under the Aventis Patent
Rights, Aventis Know-How, and Aventis’ interest in the Joint Intellectual
Property existing at the effective date of termination to Develop, make, have
made, use, import, offer to sell and sell the VEGF Products inside and outside
of the Field in the Territory.
(b)    Aventis shall transfer and assign to Regeneron (or its nominee) all
Approvals and regulatory filings (including Registration Filings) made or
obtained by Aventis or its Affiliates or any of its or their sublicensees or
Distributors to the extent specifically relating to the Licensed Products (other
than Approvals for Aventis manufacturing facilities).
(c)    Aventis shall assign and transfer to Regeneron (or its nominee) Aventis’
entire right, title and interest in and to all Product Trademarks to the extent
specifically relating to the Licensed Products and to any domain names
containing such Product Trademarks; provided that nothing herein is intended to
convey any rights in or to Aventis’ corporate name and logos or any trade names
of Aventis (other than the Product Trademarks).
(d)    Aventis shall provide to Regeneron (or its nominee) a copy (or originals
to the extent required by any Regulatory Authority in connection with the
manufacture,

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

Development or Commercialization of the Licensed Products in the Territory) of
all information (including any Party Information and/or New Information)) in its
possession or under its control to the extent directly relating to any Licensed
Products, including, without limitation, all information contained in the
regulatory and/or safety databases, all in the format then currently maintained
by Aventis, or such other format as may be reasonably requested by Regeneron.
(e)    [****].
(f)    [****].
(g)    Without limitation of Aventis’ other obligations under this Schedule 6,
Aventis will take the actions required by subparagraph (g)(i) below to the
extent it is responsible for supplying Commercial Supply Requirements of such
Licensed Product in such country pursuant to ARTICLE 8
(i)    Aventis will supply Regeneron with Clinical Supply Requirements and/or
Commercial Supply Requirements of finished and packaged Licensed Products at the
same price, and on such other terms and conditions on which Aventis was
supplying, or in the absence of termination, would have been required to supply
such finished and packaged Licensed Products, through the second anniversary of
the effective date of termination of this Agreement or such shorter period if
Regeneron notifies Aventis that it is able to manufacture or have manufactured
Licensed Products on comparable financial terms.
3.    Without limitation of the generality of the foregoing, the Parties shall
use Commercially Reasonable Efforts to complete the transition of the
Development and Commercialization of the Licensed Products hereunder to
Regeneron (or its sublicensee or third party designee) as soon as is reasonably
possible.
4.    For the avoidance of doubt, Regeneron shall not be required to provide
Aventis any consideration in exchange for the licenses, transfers, assignments
or other rights granted to it pursuant to the provisions of this Schedule 6;
provided, however, that Regeneron shall be solely responsible for paying any
royalties, fees or other consideration that Aventis 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; and provided, further, that if Aventis continues to
manufacture the Licensed Products in such terminated country pursuant to
paragraph (g) above, Regeneron shall purchase such products at the price, and on
such other terms and conditions specified therein.

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SCHEDULE 7
Transition Arrangements Following Termination in the Terminated Territory
1.    Aventis shall promptly collect and return, and cause its Affiliates and
its and their sublicensees and Distributors to collect and return, to Regeneron
or, at Regeneron’s request, destroy, all documents containing Party Information
or New Information directly relating to the Licensed Products in the Terminated
Territory, and shall immediately cease, and cause its Affiliates and its and
their sublicensees and Distributors to cease, all further use of any such Party
Information or New Information with respect to such Licensed Products in the
Terminated Territory. In addition, at Regeneron’s request, Aventis shall collect
and transfer to Regeneron any remaining inventory of Promotional Materials,
product samples, and Licensed Product inventory relating to the Terminated
Territory. Notwithstanding the foregoing in this Schedule 7, Aventis 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. Regeneron shall be entitled to use and disclose any such information
(including any such Party Information and/or New Information) in connection with
the manufacture, Development or Commercialization of Licensed Products.
2.    Aventis 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 and/or Commercialization of the Licensed Products in the
Terminated 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 when,
if and as requested by Regeneron:
(a)    Aventis shall grant, and does hereby grant, to Regeneron a fully paid-up,
royalty-free, exclusive license (which shall include the right to grant
sublicenses through multiple tiers) from Aventis under the Aventis Patent
Rights, Aventis Know-How, and Aventis’ interest in the Joint Intellectual
Property existing at the effective date of termination (i) to Develop, make,
have made, use, import, offer to sell and sell the VEGF Products inside and
outside of the Field in the Terminated Territory and (ii) to Develop, make, have
made, use and import the VEGF Products inside the Field in the Territory solely
in support of the Development and Commercialization of the VEGF Products in the
Terminated Territory.
(b)    Aventis shall transfer and assign to Regeneron (or its nominee) all
Approvals and regulatory filings (including Registration Filings) in the
Terminated Territory made or obtained by Aventis or its Affiliates or any of its
or their sublicensees or Distributors to the extent specifically relating to the
Licensed Products (other than Approvals for Aventis manufacturing facilities) in
the Terminated Territory.
(c)    Aventis shall assign and transfer to Regeneron (or its nominee) Aventis’
entire right, title and interest in and to all Product Trademarks in the
Terminated Territory to the extent specifically relating to the Licensed
Products and to any domain names containing such Product Trademarks; provided
that nothing herein is intended to convey any rights in or to

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Aventis’ corporate name and logos or any trade names of Aventis (other than the
Product Trademarks in the Terminated Territory).
(d)    Aventis shall provide to Regeneron (or its nominee) a copy (or originals
to the extent required by any Regulatory Authority in connection with the
manufacture, Development or Commercialization of the Licensed Products in the
Territory) of all information (including any Party Information and/or New
Information)) in its possession or under its control to the extent directly
relating to any Licensed Products in the Terminated Territory, including,
without limitation, all information contained in the regulatory and/or safety
databases with respect to such Terminated Territory, all in the format then
currently maintained by Aventis, or such other format as may be reasonably
requested by Regeneron.
(e)    [****].
(f)    [****].
(g)    Aventis shall provide to Regeneron all necessary information and
reasonable assistance in connection with Regeneron’s submissions to (including
Registration Filings) or communications with Regulatory Authorities regarding
Licensed Products, the Licensed Compound or the EYLEA Drug Substance in the
Terminated Territory.
(h)    Without limitation of Aventis’ other obligations under this Schedule 7,
Aventis will take the actions required by subparagraph (h)(i) below to the
extent it is responsible for supplying Commercial Supply Requirements of such
Licensed Product in the Terminated Territory pursuant to ARTICLE 8.
(i)    Aventis will supply Regeneron with Clinical Supply Requirements and/or
Commercial Supply Requirements of finished and packaged Licensed Products for
the Terminated Territory at the same price, and on such other terms and
conditions on which Aventis was supplying, or in the absence of termination,
would have been required to supply such finished and packaged Licensed Products,
through the second anniversary of the effective date of termination of this
Agreement or such shorter period if Regeneron notifies Aventis that it is able
to manufacture or have manufactured Licensed Products on comparable financial
terms.
3.    Without limitation of the generality of the foregoing, the Parties shall
use Commercially Reasonable Efforts to complete the transition of the
Development and Commercialization of the Licensed Products in the Terminated
Territory hereunder to Regeneron (or its sublicensee or third party designee) as
soon as is reasonably possible.
4.    Aventis shall not, and shall not permit any of its Affiliates or any of
its and their licensees, sublicensees or Distributors to, distribute, market,
promote, offer for sale or sell the Licensed Products directly or indirectly (a)
to any Person for use outside the Territory or (b) to any Person in the
Territory that Aventis or any of its Affiliates or any of its or their
licensees, sublicensees or Distributors knows or has reason to know (i) is
likely to distribute, market, promote, offer for sale or sell any Licensed
Product for use in the Terminated Territory or assist another Person to do so
(including any pharmacy, physician, hospital or other entity that is

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

engaged in any compounding activities related to the Licensed Products), or (ii)
has directly or indirectly distributed, marketed, promoted, offered for sale or
sold any Licensed Product for use in the Terminated Territory or assisted
another Person to do so. If Aventis or any of its Affiliates receives or becomes
aware of the receipt by a licensee, sublicensee or Distributor of any orders for
any Licensed Product for use in the Terminated Territory, such Person shall
refer such orders to Regeneron. Aventis shall cause its Affiliates and its and
their licensees, sublicensees and Distributors to notify Regeneron of any
receipt of any orders for any Licensed Product for use in the Terminated
Territory.

5.    Regeneron shall not, and shall not permit any of its Affiliates or any of
its and their licensees, sublicensees or distributors to, distribute, market,
promote, offer for sale or sell the Licensed Products directly or indirectly (a)
to any Person for use in the Field outside the Terminated Territory or (b) to
any Person in the Field in the Terminated Territory that Regeneron or any of its
Affiliates or any of its or their licensees, sublicensees or Distributors knows
or has reason to know (i) is likely to distribute, market, promote, offer for
sale or sell any Licensed Product for use in the Field in the Territory or
assist another Person to do so (including any pharmacy, physician, hospital or
other entity that is engaged in any compounding activities related to the
Licensed Products), or (ii) has directly or indirectly distributed, marketed,
promoted, offered for sale or sold any Licensed Product for use in the Field in
the Territory or assisted another Person to do so. If Regeneron or any of its
Affiliates receives or becomes aware of the receipt by a licensee, sublicensee
or distributor of any orders for any Licensed Product for use in the Field in
the Territory, such Person shall refer such orders to Aventis. Regeneron shall
cause its Affiliates and its and their licensees, sublicensees and distributors
to notify Aventis of any receipt of any orders for any Licensed Product for use
in the Field in the Territory.

6.    For the avoidance of doubt, Regeneron shall not be required to provide
Aventis any consideration in exchange for the licenses, transfers, assignments
or other rights granted to it pursuant to the provisions of this Schedule 7;
provided, however, that Regeneron shall be solely responsible for paying any
royalties, fees or other consideration that Aventis 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 with respect to the Terminated Territory; and provided,
further, that if Aventis continues to manufacture the Licensed Products in the
Terminated Territory pursuant to paragraph (h) above, Regeneron shall purchase
such products at the price, and on such other terms and conditions specified
therein.

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SCHEDULE 8
Notices
(a)
If to Aventis:
 
sanofi-aventis U.S. LLC
 
55 Corporate Drive
 
Bridgewater, NJ 08807
 
Attention: President
 
 
 
With a copy to: 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
 
 

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SCHEDULE 9
Regeneron Licensed Product Domain Names
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]

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SCHEDULE 10
Example of Profit Sharing Payment
An example of a calculation of profit sharing payments owed by Aventis to
Regeneron for a Contract Year if aggregate sum of the Net Sales of all Licensed
Products in the Field in the Territory in each Calendar Quarter of such Contract
Year is $US 600,000,000 would be as follows:

 
Q1
Q2
Q3
Q4
Annual Total
 
 
 
 
 
 
 
 
 
 
 
 
(A) Quarterly Net Sales*
100
130
170
200
600
(B) Cumulative Net Sales by Quarter*
100
230
400
600
 
(C) Applicable Percentage of Aggregate Net Sales, as set forth in Section 9.6(b)
[****]
 
 
 
 
(D) = ((B) x (C)) Aggregate Profit Sharing Payments Owned on Cumulative Net
Sales for all Calendar Quarters to date in such Contract Year*
[****]
 
 
 
 
(E) Portion of the Aggregate Profit Sharing Payments Paid in Prior Calendar
Quarters of such Contract Year*
[****]
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
((D)-(E)) Profit Sharing
[****]
 
 
 
 
Payment Due for Applicable Quarter*
 
 
 
 
 
 
 
 
 
 
 
Total Profit Sharing Payment for the Contract Year*
 
 
 
 
[****]
 
 
 
 
 
 
*All amounts in $US millions
 
 
 
 
 

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SCHEDULE 11

ACTUAL FULLY BURDENED MANUFACTURING COST AND PERIOD COSTS
Capitalized terms used in this Schedule 11 that are not otherwise defined herein
or in the Agreement shall have the meaning ascribed to them in the Supply
Agreement.

1.
Actual Fully Burdened Manufacturing Cost.

[****]
[****]
[****]
[****]
[****]
[****]
[****]

2.    Period Costs. “Period Costs” shall mean the following:

[****]
[****]
[****]
[****]
[****]
[****]
[****]
[****]
3.     Contract Manufacturers. With respect to any Actual Fully Burdened
Manufacturing Costs paid to contract manufacturers or other Third Parties in
connection with the manufacture of Product, [****]. [****]

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APPENDIX 1

ESTIMATED FULLY BURDENED BATCH PRICE FOR PRODUCT MANUFACTURED IN 2014 AND 2015

2014 Estimated Fully Burdened Batch Price:        $[****]1 
2015 Estimated Fully Burdened Batch Price:        $[****]1 

(1) [****].