Exhibit 10.19
 
Portions of this Exhibit Have Been
Omitted and Separately Filed with the Securities
And Exchange Commission with a Request
For Confidential Treatment
LICENSE AND COLLABORATION AGREEMENT
By and Among
AVENTIS PHARMACEUTICALS INC.,
SANOFI-AVENTIS AMERIQUE DU NORD
and
REGENERON PHARMACEUTICALS, INC.
Dated as of November 28, 2007

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TABLE OF CONTENTS

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

i

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

ii

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

iii

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

iv

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

v

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

vi

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

vii

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LICENSE AND COLLABORATION AGREEMENT
     THIS LICENSE AND COLLABORATION AGREEMENT (this “Agreement”), dated as of
November 28, 2007 (the “Effective Date”), is by and between AVENTIS
PHARMACEUTICALS INC., a corporation organized under the laws of the state of
Delaware having a principal place of business at 55 Corporate Drive,
Bridgewater, New Jersey 08807 (“Sanofi”), an indirect wholly owned subsidiary of
sanofi-aventis, a company organized under the laws of France with its principal
headquarters at 174, avenue de France, 75013 Paris, France (“Sanofi Parent”),
SANOFI-AVENTIS AMERIQUE DU NORD, a partnership organized under the laws of
France with its principal headquarters at 174 avenue de France, 75013 Paris,
France (“Sanofi Amerique”), and REGENERON PHARMACEUTICALS, INC., a corporation
organized under the laws of the state of New York having a principal place of
business at 777 Old Saw Mill River Road, Tarrytown, New York 10591 (“Regeneron”)
(with each of Sanofi and Regeneron being sometimes referred to herein
individually as a “Party” and collectively as the “Parties”, and with Sanofi
Amerique being a party to this Agreement for purposes of Sections 15.1, 15.2 and
20.11 only).
     WHEREAS, concurrently with the execution and delivery of this Agreement,
the Parties have entered into a Discovery and Preclinical Development Agreement
(the “Discovery Agreement”) whereby, upon the terms and conditions set forth
therein, Regeneron will use its proprietary VelocImmune® technology and related
suite of technologies with the objective of discovering Product Candidates (as
defined below) which Sanofi may elect, in accordance with the Discovery
Agreement, to advance into Development (as defined below) and thereupon
automatically obtain from Regeneron a license of certain rights thereto upon the
terms and conditions set forth herein;
     WHEREAS, Sanofi and its Affiliates possess knowledge and expertise in, and
resources for, developing and commercializing pharmaceutical products in the
Field in the Territory (each as defined below);
     WHEREAS, Regeneron and Sanofi desire to collaborate on the Development,
Manufacture and Commercialization of Licensed Products (each as defined below)
in the Field in the Territory upon the terms and conditions set forth herein
(the “Collaboration”); and
     NOW, THEREFORE, in consideration of the following mutual covenants
contained herein, and for other good and valuable consideration the adequacy and
sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE I
DEFINITIONS
     Capitalized terms used in this Agreement, whether used in the singular or
plural, except as expressly set forth herein, shall have the meanings set forth
below:
     1.1 “Additional Major Market Country” shall mean any country in the
Territory, other than the Major Market Countries referred to in clause (i) of
the definition thereof, in which Net Sales in the immediately preceding Contract
Year were *********** or more of

 

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aggregate Net Sales in the Territory, and such designation shall remain
effective from and after the determination of such Net Sales amount; provided,
however, that a country shall not be deemed an Additional Major Market Country
if, at the time that Net Sales in such country in a given Contract Year first
exceed *********** of aggregate Net Sales in the Territory, the Parties mutually
agree otherwise.
          1.2 “Affiliate” shall mean, with respect to any Person, another Person
which controls, is controlled by or is under common control with such Person. A
Person shall be deemed to control another Person if such Person possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such Person, whether through the ownership of voting
securities, by contract or otherwise. Without limiting the generality of the
foregoing, a Person shall be deemed to control another Person if any of the
following conditions is met: (a) in the case of corporate entities, direct or
indirect ownership of at least fifty percent (50%) of the stock or shares having
the right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with the power to direct the management and
policies of such non-corporate entities. The Parties acknowledge that in the
case of certain entities organized under the laws of certain countries outside
of the United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in such case
such lower percentage shall be substituted in the preceding sentence, provided
that such foreign investor has the power to direct the management and policies
of such entity. For purposes of this Agreement, in no event shall Sanofi or any
of its Affiliates be deemed Affiliates of Regeneron or any of its Affiliates.
For purposes of this Agreement, neither Sanofi Pasteur nor Merial Limited, nor
any of their respective subsidiaries or joint ventures, shall be deemed to be
Affiliates of Sanofi or any of its Affiliates.
          1.3 “Ancillary Agreements” means the Sanofi Stock Purchase Agreement
and the Investor Agreement.
          1.4 “Anticipated First Commercial Sale” shall mean, with respect to a
Licensed Product in the Field, the date agreed upon by the JSC in advance as the
expected date of First Commercial Sale of such Licensed Product in the Field in
a country in the Territory.
          1.5 “Approval” shall mean, with respect to each Licensed Product, any
approval (including Marketing Approvals and Pricing Approvals), registration,
license or authorization from any Regulatory Authority required for the
Development, Manufacture or Commercialization of such Licensed Product in the
Field in a regulatory jurisdiction anywhere in the world, and shall include,
without limitation, an approval, registration, license or authorization granted
in connection with any Registration Filing.
          1.6 “Aventis LLC” shall mean sanofi-aventis US LLC (successor in
interest under the Aventis Collaboration Agreement to Aventis Pharmaceuticals
Inc.).
          1.7 “Aventis Collaboration Agreement” shall mean the Collaboration
Agreement, dated as of September 5, 2003, by and between Aventis LLC and
Regeneron, as amended by the First Amendment, dated as of December 31, 2004, the
Second Amendment, dated as of January 7, 2005, the Third Amendment, dated as of
December 21, 2005, the Fourth

2

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

 

Amendment, dated as of January 31, 2006, and Section 11.2 of the Sanofi Stock
Purchase Agreement, as the same may be further amended from time to time.
          1.8 “Aventis Stock Purchase Agreement” shall mean the Stock Purchase
Agreement dated as of September 5, 2003 by and between Aventis Pharmaceuticals
Inc. and Regeneron, as amended by Sections 4.2(b) and 4.4 of the Investor
Agreement effective upon the execution and delivery of the Investor Agreement,
and as may be further amended from time to time.
          1.9 “BLA” shall mean, with respect to each Licensed Product, a
biologics license application filed with respect to such Licensed Product, as
described in the FDA regulations, including all amendments and supplements to
the application, and any equivalent filing with any Regulatory Authority.
          1.10 “Business Day” shall mean any day other than a Saturday, a Sunday
or a day on which commercial banks in New York, New York, the United States or
Paris, France are authorized or required by Law to remain closed.
          1.11 “Clinical Supply Cost” shall mean (a) the Out-of-Pocket Cost for
purchasing and/or the Manufacturing Cost to Manufacture Formulated Bulk Product
for Clinical Supply Requirements under the applicable Global Development Plan,
(b) the Out-of-Pocket Cost for purchasing and/or the Manufacturing Cost to
Manufacture, comparator agent or placebo requirements for activities
contemplated under the applicable Global Development Plan, (c) the Out-of-Pocket
Cost and/or the Manufacturing Cost for filling, packaging, labeling and delivery
of such Clinical Supply Requirements, comparator agent, combination agent and/or
placebo, as the case may be, for activities contemplated under the applicable
Global Development Plan and (d) any irrecoverable VAT or similar taxes actually
paid with respect to the Manufacture or delivery of Clinical Supply
Requirements. To the extent that manufacturing cost for comparator agent,
combination agent or placebo includes any markup over Manufacturing Cost to the
benefit of one of the Parties or its Affiliates, such markup shall be deducted
in the calculation of Clinical Supply Cost.
          1.12 “Clinical Supply Requirements” shall mean, with respect to a
Licensed Product, the quantities of such Licensed Product which are required by
a Party or the Parties for Development in the Field under this Agreement,
including, without limitation, the conduct of research, pre-clinical studies and
clinical trials in connection with a Development Plan and quantities of such
Licensed Product which are required by a Party for submission to a Regulatory
Authority in connection with any Registration Filing or Approval in the Field in
any regulatory jurisdiction in the Territory.
          1.13 “Co-Commercialize” or “Co-Commercialization” shall mean the act
of Co-Promoting in a Co-Commercialization Country.
          1.14 “Co-Commercialization Country” shall mean each country in which
Regeneron has elected to Co-Promote a Licensed Product, so long as, after
commencing such Co-Promotion, Regeneron is Co-Promoting at least one Licensed
Product in such country.

3

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          1.15 “COGS” for a Licensed Product for a Quarter shall mean cost
(calculated in accordance with IAS/IFRS) of Manufacturing the Licensed Product
sold in the Field in the Territory in the Quarter.
          1.16 “Commercial Overhead Charge” shall mean, on a country-by-country
and Licensed Product-by-Licensed Product basis in the Territory, beginning in
the Contract Year of First Commercial Sale in the applicable country, an amount
(agreed upon by the JFC at least six (6) months prior to the Anticipated First
Commercial Sale in the country) to cover **************************************,
such amount to be determined by the JFC as of January 1 of each following
Contract Year. For the avoidance of doubt, “Commercial Overhead Charge” shall
not include any amounts included in Medical Post-Approval Cost, Sales Force
Cost, Other Shared Expenses or Shared Commercial Expenses.
          1.17 “Commercial Supply Cost” shall mean the Out-of-Pocket Cost for
purchasing and/or the Manufacturing Cost for the Manufacture of Commercial
Supply Requirements, including, without limitation, scale-up after First
Commercial Sale, any filling, packaging and labeling costs, and any
irrecoverable VAT or similar taxes actually paid with respect to the Manufacture
or delivery of such Commercial Supply Requirements.
          1.18 “Commercial Supply Requirements” shall mean, with respect to each
Licensed Product, quantities of Finished Product as are required to fulfill
requirements for commercial sales, Non-Approval Trials and product sampling with
respect to such Licensed Product in the Field in the Territory.
          1.19 “Commercialize” or “Commercialization” shall mean, with respect
to a Licensed Product, any and all activities directed to marketing, promoting
(including, if applicable, Co-Promoting), detailing, distributing, importing,
offering for sale, having sold and/or selling such Licensed Product in the Field
in the Territory, including, without limitation, market research, obtaining
Pricing Approvals, pre-launch marketing ************************************.
          1.20 “Commercially Reasonable Efforts” shall mean the carrying out of
obligations or tasks by a Party in a sustained manner using good faith
commercially reasonable and diligent efforts, which efforts shall be consistent
with the exercise of prudent scientific and business judgment in accordance with
the efforts such Party devotes to products or research or development projects
owned by it of similar scientific and commercial potential. Commercially
Reasonable Efforts shall be determined on a market-by-market and Licensed
Product-by-Licensed Product basis in view of conditions prevailing at the time,
and evaluated taking into account all relevant factors, including without
limitation, the efficacy, safety, anticipated regulatory authority approved
labeling, competitiveness of the Licensed Product or alternative products that
are in the marketplace or under development by Third Parties and other
technical, scientific, legal, medical marketing and competitiveness factors. It
is anticipated that the level of effort constituting Commercially Reasonable
Efforts may change over time. In determining whether a Party has used
Commercially Reasonable Efforts, neither the profit sharing nor other payments
made or required to be made hereunder shall be factor weighed (that is, a Party
may not apply lesser resources or efforts in support of a Licensed Product
because it must share profits from sales of such Licensed Product or make any
other payments hereunder).

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          1.21 “Committee” means any of the JSC, JDC, JCC, JMC, JFC, any CRCC,
and any other committee established by the Parties or by the Committees
referenced above, each as described in Article III (together with Working Groups
or other committees contemplated herein or established in accordance with this
Agreement).
          1.22 “Competing Opt-Out Product” shall mean any Opt-Out Product having
the same Target as a Licensed Product.
          1.23 “Competing Product” shall mean, with respect to a Licensed
Product, ****************************************.
          1.24 “Confidentiality Agreements” shall mean the confidentiality
agreements between Regeneron and Sanofi Parent dated February 1, 2007 and
October 23, 2007, respectively.
          1.25 “Consolidated Payment Report” shall mean a consolidated Quarterly
report prepared by Sanofi (based on information reported under Sections 5.4 and
9.5) setting forth in reasonable detail, for each Major Market Country in the
Territory, for each Region in the Territory, and in the aggregate for all
countries in the Territory, (a) Net Sales, COGS and Shared Commercial Expenses
incurred by each Party for such Quarter, (b) Development Costs incurred by each
Party for such Quarter, (c) Other Shared Expenses incurred by each Party for
such Quarter, and (d) the Quarterly True-Up, and the component items and
calculations in determining such Quarterly True-Up, calculated in accordance
with Schedule 2.
          1.26 “Contract Sales Force” shall mean sales representatives employed
by a Third Party.
          1.27 “Contract Year” shall mean the period beginning on the Effective
Date and ending on December 31, 2008, and each succeeding consecutive twelve
(12) month period thereafter during the Term. The last Contract Year of the Term
shall begin on January 1 for the year during which termination or expiration of
the Agreement will occur, and the last day of such Contract Year shall be the
effective date of such termination or expiration.
          1.28 “Controlling Party” shall mean ***************************.
          1.29 “Co-Promote” or “Co-Promotion” shall mean the joint marketing and
promotion of Licensed Product(s) by the Parties (or their respective Affiliates)
under the same trademark in a Major Market Country pursuant to the applicable
Country/Region Commercialization Plan.
          1.30 “Country/Region Commercialization Budget” shall mean the budget
for a particular calendar year approved by the JCC for the applicable
Country/Region Commercialization Plan.
          1.31 “Country/Region Commercialization Plan” shall mean, for each
Reporting Country/Region, the three (3) year rolling plan for Commercializing
Licensed Products in the Field in such country or Region and the related
Country/Region Commercialization Budget and a

5

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non-binding budget forecast for the next two (2) calendar years, approved by the
JCC, as the same may be amended from time-to-time in accordance with the terms
of this Agreement. Each Country/Region Commercialization Plan shall set forth,
for each Licensed Product, the information, plans and forecasts set forth in
Section 6.3.
          1.32 “Country/Region Commercialization Committee”, or “CRCC” , shall
mean the committee established by the JCC for a particular Reporting
Country/Region as described in Section 3.5.
          1.33 “Detail” shall mean, with respect to each Licensed Product in the
Field, a selling presentation for such product by a representative of each
Party’s sales force, or another employee of each Party who may be deemed to be
part of the Commercialization effort for such Licensed Product (e.g., such as a
key account manager, etc.).
          1.34 “Develop” or “Development” shall mean, with respect to a Licensed
Product, the following activities undertaken or performed after the Initial IND
Filing Date for such Licensed Product: (a) activities relating to research,
pre-clinical and clinical drug development of such Licensed Product in the
Field, including, without limitation, test method development and stability
testing, assay development, toxicology, pharmacology, formulation, quality
assurance/quality control development, technology transfer, statistical
analysis, process development and scale-up, pharmacokinetic studies, data
collection and management, clinical studies (including research to design
clinical studies), regulatory affairs, project management, drug safety
surveillance activities related to clinical studies, the preparation and
submission of Registration Filings but excluding activities necessary to obtain
a Pricing Approval, reimbursement and/or listing on health care providers’ and
payers’ formularies, (b) ************************** and (c) any other research
and development activities with respect to such Licensed Product in the Field,
including, without limitation, activities to support the discovery of biomarkers
and activities to support new product formulations, delivery technologies and/or
new indications in the Field, either before or after the First Commercial Sale.
          1.35 “Development Costs” shall mean costs incurred by a Party (for
each Licensed Product, commencing with the first (1st) day of the month in which
the Opt-In Notice (as such term is defined in the Discovery Agreement) for such
Licensed Product is received by Regeneron) directly in connection with the
Development of Licensed Products in the Field in accordance with this Agreement
and the applicable Global Development Plan, including without limitation:
          (a) all Out-of-Pocket Costs, including, without limitation, fees and
expenses associated with obtaining Registration Filings and Marketing Approvals
necessary for the Development and Commercialization of the Licensed Products in
the Field under this Agreement;
          (b) Development FTE Costs;
          (c) Clinical Supply Costs;

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          (d) the costs and expenses incurred in connection with
(i) Manufacturing process, formulation, cleaning, and shipping development and
validation (other than validation batches which are sold), (ii), Manufacturing
scale-up and improvements, (iii) stability testing, (iv) quality
assurance/quality control development (including management of Third Party
fillers, packagers and labelers), and (v) internal and Third Party costs and
expenses incurred in connection with (A) qualification and validation of Third
Party contract manufacturers and vendors and (B) subject to the terms of this
Agreement, establishing a primary or secondary source supplier, including,
without limitation, the transfer of process and Manufacturing technology and
analytical methods, scale-up up to First Commercial Sale, process and equipment
validation, cleaning validation and initial Manufacturing licenses, approvals
and Regulatory Authority inspections (in each case, to the extent not included
in Clinical Supply Costs or Commercial Supply Costs);
          (e) any license fees and other payments under Licenses to the extent
attributable to the Manufacture of Clinical Supply Requirements and/or the
Development of Licensed Products in the Field under the Plans for the Territory
subject to Section 13.3(e) in this Agreement; and
          (f) any other costs or expenses specifically identified and included
in the applicable Development Plan or included as Development Costs under this
Agreement.
          1.36 “Development FTE Cost” shall mean, for all Development activities
performed in accordance with the Development Plan(s), including regulatory
activities, the product of (a) the number of FTEs required for such Development
activity as set forth in the approved Development Plan and (b) the Development
FTE Rate. For the avoidance of doubt, the activity of contract personnel shall
be charged as Out-of-Pocket Costs.
          1.37 “Development FTE Rate” shall mean ******* in the first (1st)
Contract Year, such amount to be adjusted as of January 1, 2009 and annually
thereafter by the sum of (a) the average of the percentage increases or
decreases, if any, in the US CPI and the ROW CPI for the twelve (12) months
ending June 30 of the Contract Year prior to the Contract Year for which the
adjustment is being made *******************************, the Parties shall meet
to consider a revision to the Development FTE Rate.
          1.38 “Development Plan” shall mean a Global Development Plan or an
Initial Development Plan, as the context requires.
          1.39 “Discovery Program” shall have the meaning set forth in the
Discovery Agreement.
          1.40 “EMEA” shall mean the European Medicines Evaluation Agency or any
successor agency thereto.

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          1.41 “Executive Officers” shall mean the Chief Executive Officer of
Regeneron and the Chief Executive Officer of Sanofi Parent, or their respective
designees with equivalent decision-making authority with respect to matters
under this Agreement.
          1.42 “FDA” shall mean the United States Food and Drug Administration
and any successor agency thereto.
          1.43 “Field” shall mean the treatment, prevention, palliation and/or
diagnosis of any disease.
          1.44 “Finished Product” shall mean a Licensed Product in the Field in
its finished, labeled and packaged form, ready for sale to the market or use in
clinical or pre-clinical trials, as the case may be.
          1.45 “First Commercial Sale” shall mean, with respect to a Licensed
Product in a country in the Territory, the first commercial sale of the Finished
Product to non-Sublicensee Third Parties for use in the Field in such country
(or group of countries) following receipt of Marketing Approval. Sales for test
marketing or clinical trial purposes or compassionate or similar use shall not
constitute a First Commercial Sale.
          1.46 “Formulated Bulk Product” shall mean Licensed Product in the
Field formulated into solution or in a lyophilized form, ready for storage or
shipment to a manufacturing facility, to allow processing into the final dosage
form.
          1.47 “FTE” shall mean a full time equivalent employee (i.e., one
fully-committed or multiple partially-committed employees aggregating to one
full-time employee) employed or contracted by a Party and assigned to perform
specified work, with such commitment of time and effort to constitute one
employee performing such work on a full-time basis, which for purposes of
Development shall be ***** per year.
          1.48 “GAAP” shall mean generally accepted accounting principles as
applicable in the United States.
          1.49 “Global Commercialization Budget” shall mean the budget(s) for a
particular Contract Year approved by the JCC for the applicable Global
Commercialization Plan.
          1.50 “Global Commercialization Plan” shall mean, with respect to a
Licensed Product, the three (3) year rolling plan approved by the JSC for
Commercializing such Licensed Product throughout the world, including the
related Global Commercialization Budget and a non-binding budget forecast for
the next two (2) Contract Years, as the same may be amended from time-to-time in
accordance with the terms of this Agreement. Each Global Commercialization Plan
shall set forth (if not otherwise set forth in the applicable Country/Region
Commercialization Plan(s)) for a Licensed Product, the information, plans and
forecasts set forth in Section 6.2.
          1.51 “Global Development Budget” shall mean the budget(s) for a
particular Contract Year approved by the JSC for the applicable Global
Development Plan.

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          1.52 “Global Development Plan” shall mean, with respect to a Licensed
Product, the Initial Development Plan and the three (3) year rolling plan
approved by the JSC for the worldwide Development of such Licensed Product,
including the related Global Development Budget and a non-binding budget
forecast for the next two (2) Contract Years, as the same may be amended from
time-to-time in accordance with the terms of this Agreement. For the avoidance
of doubt, a Global Development Plan will not include Non-Approval Trials.
          1.53 “Good Practices” shall mean compliance with the applicable
standards contained in then-current “Good Laboratory Practices,” “Good
Manufacturing Practices” and/or “Good Clinical Practices,” as promulgated by the
FDA and all analogous guidelines promulgated by the EMEA or the ICH, as
applicable.
          1.54 “Governmental Authority” shall mean any court, agency, authority,
department, regulatory body or other instrumentality of any government or
country or of any national, federal, state, provincial, regional, county, city
or other political subdivision of any such government or any supranational
organization of which any such country is a member.
          1.55 “IAS/IFRS” shall mean International Accounting
Standards/International Financial Reporting Standards of the International
Accounting Standards Board.
          1.56 “ICH” shall mean the International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for Human Use.
          1.57 “IND” shall mean, with respect to each Licensed Product in the
Field, an Investigational New Drug Application filed with respect to such
Licensed Product, as described in the FDA regulations, including all amendments
and supplements to the application, and any equivalent filing with any
Regulatory Authority outside the United States.
          1.58 “Indication” means any disease.
          1.59 “Initial Development Plan” shall have the meaning set forth in
the Discovery Agreement.
          1.60 “Initial IND Filing Date” means, with respect to a Licensed
Product, the date an IND for such Licensed Product is first filed.
          1.61 “Investor Agreement” means the Investor Agreement by and among
Sanofi Parent, Sanofi, Aventis LLC, Sanofi Amerique and Regeneron, substantially
in the form of Exhibit B to the Sanofi Stock Purchase Agreement, which will be
entered into concurrently with the closing under the Sanofi Stock Purchase
Agreement.
          1.62 “Joint Patent Rights” shall mean Patent Rights that cover a Joint
Invention.
          1.63 “Know-How” shall mean, with respect to each Party and its
Affiliates, any and all proprietary technical or scientific information,
know-how, data, test results, knowledge, techniques, discoveries, inventions,
specifications, designs, trade secrets, regulatory filings and other
information, including marketing and supply information, (whether or not
patentable or

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otherwise protected by trade secret Law) and that are not disclosed or claimed
by such Party’s Patents or Patent Applications.
          1.64 “Law” or “Laws” shall mean all laws, statutes, rules,
regulations, orders, judgments, injunctions and/or ordinances of any
Governmental Authority.
          1.65 “Lead Regulatory Party” shall mean the Party having
responsibility for preparing, prosecuting and maintaining Registration Filings
and any Approvals for Licensed Products in the Field under this Agreement, and
for related regulatory duties.
          1.66 “Legal Dispute” shall mean any dispute related to a Party’s
alleged failure to comply with this Agreement or the validity, breach,
termination or interpretation of this Agreement.
          1.67 “License” shall mean any license from a Third Party approved by
the JSC required for the Development, Manufacture or Commercialization of any
Licensed Product in the Field under this Agreement.
          1.68 “Licensed Products” shall mean (i) Product Candidates as to which
Sanofi has exercised its Opt-In Rights in accordance with Section 5.4 of the
Discovery Agreement, (ii) any Competing Product that is included in the
Collaboration pursuant to Section 2.6(c) below, (iii) REGN88 (IL-6RmAB) and
Delta-like ligand-4(D-ll4) and (iv) ******************** (as defined in the
Discovery Agreement) once included in the Collaboration pursuant to
Section 2.11(b) of the Discovery Agreement.
          1.69 “Major Market Country” shall mean any of the following:
***************************************.
          1.70 “Manufacture” or “Manufacturing” shall mean activities directed
to producing, manufacturing, processing, filling, finishing, packaging,
labeling, quality assurance testing and release, shipping and/or storage of
Formulated Bulk Product, Finished Product, placebo or a comparator agent, as the
case may be.
          1.71 “Marketing Approval” shall mean an approval of the applicable
Regulatory Authority necessary for the marketing and sale of a Licensed Product
in an indication in the Field in any country, but excluding any separate Pricing
Approval.
          1.72 “Manufacturing Plan” shall mean the manufacturing plan as
prepared by the JMC as described in Section 8.5.
          1.73 “Medical Post-Approval Cost” shall mean, for Licensed Product(s)
in each country in the Territory, the product of (a) the number of office-based
people supporting (i) the coordination of Non-Approval Trials,
(ii) post-Approval non-clinical pharmacovigilance, (iii) the maintenance of
Approvals, and (iv) Pricing Approvals (with the number and the method of
calculating such number set forth in the applicable Country/Region
Commercialization Plan or Global Commercialization Plan) and (b) the applicable
Medical Post-Approval FTE Rate. The calculation of the number of people in
(a) above will be designed to ensure the proper reporting

10

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and auditing of such information in accordance with this Agreement. For the
avoidance of doubt, the activities of contract personnel shall be charged as an
Out-of-Pocket Cost.
          1.74 “Medical Post-Approval FTE Rate” shall mean, on a
Region-by-Region or one or more Major Market Countries basis in the Territory
(determined based on the location of the medical affairs professional), a rate
agreed upon in local currency by the Parties prior to the expected start of the
first Non-Approval Trial in such Region or Major Market Country, as applicable,
based upon the fully burdened cost of medical affairs professionals of
pharmaceutical companies in the Field in the applicable country, such amount to
be adjusted as of January 1 of each following Contract Year by the percentage
increase or decrease, if any, in the applicable CPI through June 30 of the prior
calendar year. The Medical Post-Approval FTE Rate shall be inclusive of
Out-of-Pocket Costs and other expenses for the employee providing the services,
including travel costs and allocated costs, such as, for example, allocated
overhead costs.
          1.75 “Net Sales” shall mean the gross amount invoiced for bona fide
arms’ length sales of Licensed Products in the Field in the Territory by or on
behalf of a Party or its Affiliates or Sublicensees to Third Parties, less the
following deductions, determined in accordance with IAS/IFRS (or GAAP for the
US) consistently applied:
          (a) normal and customary trade, cash, quantity and free-goods
allowances granted and taken directly with respect to sales of such Licensed
Products;
          (b) amounts repaid or credited by reason of defects, rejections,
recalls, returns, rebates, allowances and billing errors;
          (c) chargebacks and other amounts paid on sale or dispensing of
Licensed Products;
          (d) Third Party cash rebates and chargebacks related to sales of
Licensed Products, to the extent allowed;
          (e) retroactive price reductions that are actually allowed or granted;
          (f) compulsory refunds, credits and rebates directly related to the
sale of Licensed Products, accrued, paid or deducted pursuant to agreements
(including, but not limited to, managed care agreements) or government
regulations;
          (g) freight, postage, shipment and costs (or wholesale fees in lieu of
those costs) and customs duties incurred in delivering Licensed Products that
are separately identified on the invoice or other documentation;
          (h) sales taxes, excess duties, or other consumption taxes and
compulsory payments to Governmental Authorities or other governmental charges
imposed on the sale of Licensed Products, which are separately identified on the
invoice or other documentation; and
          (i) as agreed by the Parties, any other specifically identifiable
costs or charges included in the gross invoiced sales price of such Licensed
Product falling within

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categories substantially equivalent to those listed above and ultimately
credited to customers or a Governmental Authority or agency thereof.
Net Sales in currency other than United States Dollars shall be translated into
United States Dollars according to the provisions of Section 9.8 of this
Agreement. Sales between the Parties, or between the Parties and their
Affiliates or Sublicensees, for resale, shall be disregarded for purposes of
calculating Net Sales. Any of the items set forth above that would otherwise be
deducted from the invoice price in the calculation of Net Sales but which are
separately charged to, and paid by, Third Parties shall not be deducted from the
invoice price in the calculation of Net Sales. In the case of any sale of a
Licensed Product for consideration other than cash, such as barter or
countertrade, Net Sales shall be calculated on the fair market value of the
consideration received as agreed by the Parties. Solely for purposes of
calculating Net Sales, if Sanofi or its Affiliate or Sublicensee sells such
Licensed Products in the form of a combination product containing any Licensed
Product and one or more active ingredients (whether combined in a single
formulation or package, as applicable, or formulated or packaged separately but
sold together for a single price in a manner consistent with the terms of this
Agreement) (a “Combination Product”), then prior to the First Commercial Sale of
such Combination Product, the Parties shall agree through the JFC to the value
of each component of such Combination Product and the appropriate method for
accounting for sale of such Combination Product. For the avoidance of doubt, for
the purposes of this Agreement, Immunoconjugates (as such term is defined in the
Discovery Agreement) shall not be deemed Combination Products.
     Solely for the purposes of Section 2.6(d) of this Agreement, the term
“Licensed Product” as used in the definition of Net Sales shall refer to Opt-Out
Products.
          1.76 “New Information” shall mean any and all ideas, inventions, data,
writings, protocols, discoveries, improvements, trade secrets, materials or
other proprietary information not generally known to the public, which may arise
or be conceived or developed by either Party or its Affiliates, or by the
Parties or their Affiliates jointly, during the Term pursuant to this Agreement,
to the extent specifically related to any Licensed Product in the Field,
including, without limitation, information and data included in any Plans or
Registration Filings made under this Agreement.
          1.77 “Non-Approval Trials” shall mean any post-marketing surveys,
registries and clinical trials post-first Marketing Approval not intended to
gain additional labeled Indications, but excluding any post-first Marketing
Approval clinical trials required by Regulatory Authorities to maintain
Marketing Approvals of existing labeled Indication(s).
          1.78 “Opt-In Right”shall have the meaning set forth in the Discovery
Agreement.
          1.79 “Opt-Out Product” shall mean a Licensed Product as to which this
Agreement has been terminated in accordance with Section 19.2. For clarity, an
Early Development Opt-Out Product shall not constitute an Opt-Out Product.
          1.80 “Other Shared Expenses” shall mean those costs and expenses
specifically referred to in Sections 7.6, 12.1(a), 12.2(e), 12.3(b), 13.1(c),
13.3(b), 13.3(d) and 17.1(c).

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          1.81 “Out-of-Pocket Costs” shall mean costs and expenses paid to Third
Parties (or payable to Third Parties and accrued in accordance with GAAP or
IAS/IFRS) by either Party and/or its Affiliates in accordance with a Plan, if
applicable.
          1.82 “Party Information” shall mean any and all trade secrets or other
proprietary information, including, without limitation, any proprietary data,
inventions, ideas, discoveries and materials (whether or not patentable or
protectable as a trade secret) not generally known to the public regarding a
Party’s or its Affiliates’ technology, products, business or objectives, in each
case, other than New Information, which are disclosed or made available by a
Party or such Party’s Affiliates to the other Party or the other Party’s
Affiliates in connection with this Agreement.
          1.83 “Patent Application” shall mean any application for a Patent.
          1.84 “Patent Rights” shall mean unexpired Patents and Patent
Applications.
          1.85 “Patents” shall mean patents and all substitutions, divisions,
continuations, continuations-in-part, reissues, reexaminations and extensions
thereof and supplemental protection certificates relating thereto, and all
counterparts thereof in any country in the world.
          1.86 “Person” shall mean and include an individual, partnership, joint
venture, limited liability company, corporation, firm, trust, unincorporated
organization and government or other department or agency thereof.
          1.87 “Phase 3 Trial” shall mean a clinical trial that is designed to
gather further evidence of safety and efficacy of a Licensed Product in the
Field (and to help evaluate its overall risks and benefits) and is intended to
support Marketing Approval for a Licensed Product in the Field in one or more
countries in the Territory. A Phase 3 Trial typically follows at least one dose
ranging clinical trial to evaluate further the efficacy and safety of a Licensed
Product in the Field in the targeted patient population and to help define the
optimal dose and/or dosing regimen.
          1.88 “Plan” shall mean any Country/Region Commercialization Plan,
Global Commercialization Plan, Global Development Plan, Initial Development
Plan, Manufacturing Plan or other plan approved through the Committee process
relating to the Development, Manufacture or Commercialization of any Licensed
Product in the Field under this Agreement.
          1.89 “Positive Phase 3 Trial Results” shall mean a Phase 3 Trial that
meets its primary end-point as defined in the study protocol for such Phase 3
Trial, and the safety profile supports continued clinical testing in the
applicable Indication and/or filing of an application for Marketing Approval.
          1.90 “Pre-Launch Marketing Expenses” shall mean, with respect to a
Licensed Product, on a country-by-country basis in the Territory, with respect
to each Licensed Product, all Commercialization expenses to support such
Licensed Product in the Field incurred
*************************************************************.

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          1.91 “Pricing Approval” shall mean such approval, agreement,
determination or governmental decision establishing prices for a Licensed
Product that can be charged to consumers and will be reimbursed by Governmental
Authorities in countries in the Territory where Governmental Authorities or
Regulatory Authorities of such country approve or determine pricing for
pharmaceutical products for reimbursement or otherwise.
          1.92 “Product Candidate” shall have the meaning set forth in the
Discovery Agreement.
          1.93 “Product Trademark” shall mean, with respect to each Licensed
Product in the Field in the Territory, the trademark(s) selected by the JCC and
approved by the JSC for use on such Licensed Product throughout the Territory
and/or accompanying logos, slogans, trade names, trade dress and/or other
indicia of origin, in each case as selected by the JCC and approved by the JSC.
          1.94 “Promotional Materials” shall mean, with respect to each Licensed
Product, promotional, advertising, communication and educational materials
relating to such Licensed Product for use in connection with the marketing,
promotion and sale of such Licensed Product in the Field in the Territory, and
the content thereof, and shall include, without limitation, promotional
literature, product support materials and promotional giveaways.
          1.95 “Quarter” or “Quarterly” shall refer to a calendar quarter,
except that the first (1st) Quarter shall commence on the Effective Date and
extend to the end of the then-current calendar quarter and the last calendar
quarter shall extend from the first day of such calendar quarter until the
effective date of the termination or expiration of the Agreement.
          1.96 “Regeneron Intellectual Property” shall mean the Regeneron Patent
Rights and any Know-How of Regeneron or any of its Affiliates.
          1.97 “Regeneron Know-How” shall mean any and all Know-How now or
hereafter during the term of the Discovery Program or the Collaboration owned
by, licensed to or otherwise held by Regeneron or any of its Affiliates (other
than Sanofi Know-How and Know-How included in Joint Inventions) with the right
to sublicense the same that relate to a Licensed Product in the Field and are
necessary or useful for the Development, Manufacture or Commercialization of a
Licensed Product in the Field, including, without limitation, New Information.
          1.98 “Regeneron Patent Rights” shall mean those Patent Rights which,
(a) at the Effective Date or at any time thereafter during the Term, are owned
by, licensed to or otherwise held by Regeneron or any of its Affiliates (other
than Sanofi Patent Rights and Patent Rights included in Joint Inventions), with
the right to license or sublicense the same, and (b) include at least one Valid
Claim which would be infringed by the Development, Manufacture or
Commercialization of a Licensed Product in the Field, but only to such extent.
          1.99 “Region” shall mean such countries or group of countries as
determined by the JCC.

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          1.100 “Registration Filing” shall mean the submission to the relevant
Regulatory Authority of an appropriate application seeking any Approval, and
shall include, without limitation, any IND or Marketing Approval application in
the Field.
          1.101 “Regulatory Authority” shall mean any federal, national,
multinational, state, provincial or local regulatory agency, department, bureau
or other governmental entity anywhere in the world with authority over the
Development, Manufacture or Commercialization of any Licensed Product in the
Field under this Agreement. The term “Regulatory Authority” includes, without
limitation, the FDA, the EMEA and the Japanese Ministry of Health, Labour and
Welfare.
          1.102 “Reporting Country/Region” shall mean each Major Market Country,
and each other country or Region for which a Country/Region Commercialization
Committee has been established by the JCC.
          1.103 “Rest of World” or “ROW” shall mean all Rest of World Countries.
          1.104 “Rest of World Country” shall mean any country in the Territory
other than the United States.
          1.105 “ROW CPI” shall mean the “EU15 CPI” (or its successor equivalent
index), which is published monthly and available via The Bloomberg Professional,
as published by Bloomberg L.P.
          1.106 “Sales Force Cost” shall mean, for Licensed Product(s) in each
country in the Territory, the product of (a) the number of detailing people
(with the number and the method of calculating such number set forth in the
applicable Country/Region Commercialization Plan or Global Commercialization
Plan), and (b) **********************************. The calculation of the number
of detailing people in (a) above will be based on
****************************************************. For the avoidance of
doubt, the activities of contract personnel, including contract Sales Force,
shall be charged as Out-of-Pocket Costs.
          1.107 “Sales Force FTE Rate” shall mean, on a Region-by-Region or one
or more Major Market Countries basis (determined based on the location of the
sales representative), a rate agreed upon in local currency by the Parties at
least eighteen (18) months prior to the Anticipated First Commercial Sale in the
Region or Major Market Country, as applicable, based upon the fully burdened
cost of sales representatives of pharmaceutical companies in the Field in the
applicable country, and including an allocation of regional and country sales
force management cost, to be approved six (6) months prior to the first
Commercial Sale, such amount to be adjusted as of January 1 of each following
Contract Year by the percentage increase or decrease, if any, in the applicable
CPI through June 30 of the prior calendar year. The Sales Force FTE Rate shall
be inclusive of Out-of-Pocket Costs and other expenses for the employee
providing the services, including travel costs, information systems and
allocated costs, such as, for example, allocated overhead costs.

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          1.108 “Sanofi Intellectual Property” shall mean the Sanofi Patent
Rights and the Sanofi Know-How.
          1.109 “Sanofi Know-How” shall mean any and all Know-How now or
hereafter during the term of the Discovery Program or the Collaboration owned
by, licensed to or otherwise held by Sanofi or its Affiliates (other than
Regeneron Know-How and Know-How included in Joint Inventions) with the right to
sublicense the same that relate to a Licensed Product in the Field and are
necessary or useful for the Development, Manufacture or Commercialization of a
Licensed Product in the Field, including, without limitation, New Information.
          1.110 “Sanofi Patent Rights” shall mean those Patent Rights which,
(a) at the Effective Date or at any time thereafter during the Term, are owned
by, licensed to or otherwise held by Sanofi or any of its Affiliates (other than
Regeneron Patent Rights and Patent Rights included in Joint Inventions), with
the right to license or sublicense the same, and (b) include at least one Valid
Claim which would be infringed by the Development, Manufacture or
Commercialization of a Licensed Product in the Field, but only to such extent.
          1.111 “Sanofi Stock Purchase Agreement” means the Stock Purchase
Agreement dated as of the Effective Date by and between Sanofi Amerique, Aventis
LLC and Regeneron.
          1.112 “Shared Commercial Expenses” shall mean the sum of the following
items, in each case to the extent directly attributable to Commercialization of
Licensed Products in the Field in the Territory in accordance with an approved
Country/Region Commercialization Plan or Global Commercialization Plan:
          (a) ********************************** to cover the cost of
distribution, freight, insurance and warehousing, related to the sale of
Licensed Products in the Field in the Territory, less any amount deducted from
Net Sales pursuant to clause (g) of the definition of Net Sales;
          (b) bad debt attributable to Licensed Products in the Field sold in
the Territory;
          (c) Sales Force Cost;
          (d) Medical Post-Approval Cost;
          (e) Out-of-Pocket Costs related to (i) the marketing, advertising
and/or promotion of Licensed Products in the Field in the Territory (including,
without limitation, pricing activities, commercial pharmacovigilance,
educational expenses, advocate development programs and symposia and Promotional
Materials), (ii) market research for Licensed Products in the Field in the
Territory and (iii) the preparation of training and communication materials for
Licensed Products in the Field in the Territory;
          (f) a portion of Out-of-Pocket Costs agreed upon by the Parties
related to the marketing, advertising and promotion of Licensed Products in the
Field in the

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Territory (including, without limitation, educational expenses, advocate
development programs and symposia, and promotional materials) to the extent such
marketing, advertising and promotion relate to both Licensed Products and other
products developed or commercialized by Sanofi or its Affiliates as agreed upon
in an approved Global Commercialization Plan or Country/Region Commercialization
Plan;
          (g) Out-of-Pocket Costs related to Non-Approval Trials for Licensed
Products in the Field in the Territory, including, without limitation, the
Out-of-Pocket Cost of clinical research organizations, investigator and expert
fees, lab fees and scientific service fees, the Out-of-Pocket Cost of shipping
clinical supplies to centers or disposal of clinical supplies, in each case, to
the extent not included in Commercial Supply Cost;
          (h) Out-of-Pocket Costs related to Pricing Approvals and the
maintenance of all Approvals directly related to the Commercialization of
Licensed Products in the Field in the Territory;
          (i) Commercial Overhead Charge;
          (j) Pre-Launch Marketing Expenses;
          (k) Out-of-Pocket Costs related to regulatory affairs activities,
other than activities to secure Registration Filing of indications and line
extensions; and
          (l) any other costs or expenses directly related to the
Commercialization of a Licensed Product after First Commercial Sale of such
Licensed Product and not included in clauses (a) through (k) above.
     The foregoing shall not include any costs which have been included in
Development Costs. For clarity, it is the intent of the Parties that costs and
headcount included in the foregoing will be fairly allocated to the Licensed
Products in the Field in the Territory (to the extent that any Shared Commercial
Expense is attributable, in part, to products or activities other than the
Licensed Products in the Field in the Territory) and, in each case, will only be
included once in the calculation of the Quarterly True-Up.
          1.113 “Shared Phase 3 Trial Costs” shall mean Development Costs
associated with Phase 3 Trials of any Licensed Product incurred after the
receipt of first Positive Phase 3 Trial Results for such Licensed Product.
          1.114 “Sublicensee” shall mean a Third Party or an Affiliate to whom
Sanofi will have granted a license or sublicense under Sanofi’s rights pursuant
to Section 4.3 to Commercialize Licensed Products in the Field in the Territory.
For the avoidance of doubt, a “Sublicensee” will include a Third Party to whom
Sanofi will have granted the right to distribute Licensed Products in the Field
wherein such distributor pays to Sanofi a royalty (or other amount) based upon
the revenues received by the distributor for the sale (or resale) of Licensed
Products by such distributor.

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          1.115 “Target” shall mean any gene, receptor, ligand or other molecule
(a) associated with a disease activity that may be modified by direct
interaction with a Licensed Product or (b) to which a Licensed Product binds.
          1.116 “Terminated Licensed Product”shall mean a Licensed Product as to
which this Agreement has been terminated in accordance with its terms in
accordance with Article XIX, and shall include any Opt-Out Product.
          1.117 “Termination Notice Period” shall mean the Sanofi Termination
Notice Period or the Regeneron Termination Notice Period, as applicable.
          1.118 “Territory” shall mean all the countries and territories of the
world.
          1.119 “Third Party” shall mean any Person other than Sanofi or
Regeneron or any Affiliate of either Party.
          1.120 “United States,” “US” or “U.S.” shall mean the United States of
America (including its territories and possessions) and Puerto Rico.
          1.121 “US CPI” shall mean the Consumer Price Index — All Urban
Consumers published by the United States Department of Labor, Bureau of
Statistics (or its successor equivalent index).
          1.122 “Valid Claim” shall mean (a) a claim of an issued and unexpired
Patent (including the term of any patent term extension, supplemental protection
certificate, renewal or other extension) which has not been held unpatentable,
invalid or unenforceable in a final decision of a court or other Governmental
Authority of competent jurisdiction from which no appeal may be or has been
taken, and which has not been admitted to be invalid or unenforceable through
reissue, re-examination, disclaimer or otherwise; or (b) a claim of a Patent
Application, which claim has been pending less than five (5) years from the
original priority date of such claim in a given jurisdiction, unless or until
such claim thereafter issues as a claim of an issued Patent (from and after
which time the same shall be deemed a Valid Claim subject to paragraph
(a) above).
          1.123 Additional Definitions. Each of the following definitions is set
forth in the Sections (or Schedules) of this Agreement indicated below:

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

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

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

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

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Party shall, subject to the terms and conditions set forth in Article XVI,
provide (or cause its Affiliates to provide) to any relevant Committee any
necessary Party Information, New Information and such other information and
materials as may be reasonably required for the Parties to operate effectively
and efficiently under and in accordance with the terms and conditions of this
Agreement.
          2.2 Compliance With Law. Both Sanofi and Regeneron, and their
respective Affiliates, shall perform their obligations under this Agreement in
accordance with applicable Law. No Party or any of its Affiliates shall, or
shall be required to, undertake any activity under or in connection with this
Agreement which violates, or which it believes, in good faith, may violate, any
applicable Law.
          2.3 Further Assurances and Transaction Approvals. Upon the terms and
subject to the conditions hereof, each of the Parties will use Commercially
Reasonable Efforts to (a) take, or cause to be taken, all actions necessary,
proper or advisable under applicable Laws or otherwise to consummate and make
effective the transactions contemplated by this Agreement, (b) obtain from the
requisite Governmental Authorities any consents, licenses, permits, waivers,
approvals, authorizations or orders required to be obtained or made by such
Party in connection with the authorization, execution and delivery by such Party
of this Agreement and the consummation by such Party of the transactions
contemplated by this Agreement and (c) make all necessary filings, and
thereafter make any other advisable submissions, with respect to this Agreement
and the transactions contemplated by this Agreement required to be made by such
Party under applicable Laws. The Parties will cooperate with each other in
connection with the making of all such filings. Each Party will furnish to the
other Party all information in its possession or under its control required for
any applicable or other filing to be made pursuant to the rules and regulations
of any applicable Laws in connection with the transactions contemplated by this
Agreement.
          2.4 Compliance with Third Party Agreements. Each Party agrees to
comply with the obligations set forth in (a) the Licenses to which it is a party
and to notify the other Party of any terms or conditions in any such License
with which such other Party is required to comply as a licensee or sublicensee,
as the case may be, and (b) any other material agreement, including any
sublicense under a License referenced in subsection (a) above, to which it is a
party and that is related to the Collaboration, including, without limitation,
any obligations to pay royalties, fees or other amounts due thereunder. Neither
Party may terminate or amend any License or any other material agreement entered
into pursuant to a Plan without the prior written consent of the other Party,
such consent not to be unreasonably withheld or delayed, if the amendment or
termination imposes any material liability or restriction on either Party with
respect to the Development, Manufacture or Commercialization of Licensed
Products in the Field in the Territory.
          2.5 Plans. The Parties shall undertake all Development and
Commercialization activities under this Agreement solely in accordance with the
Committee approved Plans. The Parties may agree to amend all Plans and budgets
from time to time as circumstances may require.
          2.6 Limitation on Exercise of Rights Outside of Collaboration.

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          (a) Non-Compete. Without limitation of and in addition and subject to
Section 2.8 of the Discovery Agreement, during the Term, except as set forth in
this Agreement or Section 2.8 of the Discovery Agreement, neither Party nor any
of its Affiliates, either alone or through any Third Party, shall Develop or
Commercialize any Competing Product.
          (b) Regeneron Sole Development. If Regeneron presents a proposal to
the JDC to undertake additional clinical trials not contemplated in a Global
Development Plan to support a Licensed Product in the Field and the JDC fails to
approve the proposal within the timeframe established by the JDC pursuant to
Section 5.5, then Regeneron may, at its option and at its sole expense, conduct
such additional clinical trial(s) outside the scope of the applicable Global
Development Plan; provided, however, Regeneron must first present the proposed
protocols and clinical trial designs to Sanofi for approval, such approval not
to be unreasonably withheld or delayed and, for other than Non-Approval Trials,
shall also present to Sanofi the related budgets for Clinical Supply Costs and
Out-of-Pocket Costs and applicable FTE costs (provided that such budgets shall
be provided for informational purposes only and may not be used to disapprove
such protocols and designs). Regeneron shall also provide to Sanofi drug safety
data from such additional clinical trials in accordance with Section 7.4. The
Sanofi representatives on the JDC may disapprove any such protocols or clinical
trial designs for reasons of safety or Sanofi reasonably believes that the
development as described in this Section 2.6(b) would have a material adverse
effect on the overall development strategy for the Licensed Product and/or the
commercial viability of such License Product, including the magnitude of sales
for such Licensed Product. If, in compliance with this Section 2.6(b), Sanofi
does not approve any such protocols or clinical trial designs for reasons as
described herein, Regeneron may not proceed with the proposed clinical trials
unless Regeneron disputes such disapproval and until the dispute has been
resolved, as provided in Section 3.11(b) and, if necessary, Section 10.4, in
Regeneron’s favor. In the event that Regeneron conducts any such additional
clinical trials, all results, Know-How and Patent Rights generated in or arising
from any such clinical trial shall be subject to the grants of rights pursuant
to Article IV of this Agreement. For the avoidance of doubt, no consideration or
reimbursement shall be paid to Regeneron with respect to the conduct of any such
additional clinical trials; provided, however, that if the Parties subsequently
agree to commence a further clinical trial based on the results of such
additional clinical trial(s) or data is used from such additional clinical
trial(s) to support an Approval in the Territory, then Sanofi shall be required
to reimburse Regeneron for ************* of the actual Out-of-Pocket Costs and
Clinical Supply Costs and applicable FTE costs incurred in connection with the
conduct of such additional clinical trial(s) that are consistent with the
budgets provided to Sanofi pursuant to this Section 2.6(b) and the other terms
of this Agreement. Publication of any results or data obtained in conducting the
additional clinical trial(s) allowed under this Section 2.6(b) shall be subject
to Article XVI.
          (c) Company Acquisitions. Notwithstanding Section 2.6(a), if as the
result of an acquisition of a Third Party (such acquisition a “Third Party
Acquisition) by a Party or one or more of its Affiliates (the “Acquiring
Party”), the Acquiring Party

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acquires rights to a product that is a Competing Product (the “Acquired
Competing Product”) to a Licensed Product (the “Competing Licensed Product”),
the Acquiring Party, at its sole discretion, shall do one of the following:
(W) present a proposal to the JDC to include the Acquired Competing Product in
the Collaboration in accordance with Section 2.6(c)(i); (X) deliver to the other
Party (the “Non-Acquiring Party”) a termination notice, pursuant to
Section 19.2(a) or 19.2 (b), as appropriate, and Section 2.6(c)(ii), with regard
to the Competing Licensed Product; or (Y) transfer its rights in the Acquired
Competing Product to a Third Party pursuant to Section 2.6(c)(iii).
          (i) Proposal for Inclusion. If the Acquiring Party chooses this
alternative, within ten (10) Business Days after the closing of such Third Party
Acquisition, the Acquiring Party shall present a proposal to the JDC to include
such Acquired Competing Product in the Collaboration based on the terms of this
Agreement. As part of such presentation, the Acquiring party shall provide the
JDC with all information with respect to such Acquired Competing Product
reasonably available to the Acquiring Party and material to a decision by the
Non-Acquiring Party’s representatives on the JDC as to whether to approve the
inclusion of such Acquired Competing Product in the Collaboration. The JDC
shall, on or before the date which is twenty (20) Business Days after the
closing of such Third Party Acquisition, decide whether to approve the inclusion
of such Acquired Competing Product in the Collaboration under the terms of this
Agreement. If the JDC timely approves the inclusion of such Acquired Competing
Product in the Collaboration, then upon the closing of such Third Party
Acquisition the Acquired Competing Product shall automatically be included in
the Collaboration as a Licensed Product hereunder. If the JDC does not approve
such inclusion, the Acquiring Party shall elect whether to deliver to the
Non-Acquiring Party a termination notice, pursuant to Section 19.2(a) or 19.2
(b), as appropriate, and Section 2.6(c)(ii), with regard to the Competing
Licensed Product or transfer its rights to the Acquired Competing Product to a
Third Party (without any consideration or payment to the Non-Acquiring Party in
accordance with Section 2.6(c)(iii) below).
          (ii) Termination of Licensed Product. If the Acquiring Party chooses
this alternative, the Acquiring Party shall deliver to the Non-Acquiring Party,
within ten (10) Business Days after the decision of the JDC not to include the
Acquired Competing Product in the Collaboration pursuant to Section 2.6(c)(i), a
termination notice pursuant to Section 19.2(a) or 19.2(b), as applicable, with
respect to the Competing Licensed Product (the “Opt-Out Product Notice”). The
provisions of Section 19.2(a) or 19.2(b), as applicable, and the provisions of
Sections 19.7, 19.8 and Schedule 4 or 5, as applicable, shall then apply to such
Competing Licensed Product. For the avoidance of doubt, such Competing Licensed
Product shall then be an Opt-Out Product, and notwithstanding any other
provision of this Agreement, the Acquiring Party shall be deemed (without any
requirement of notice to the Non-Acquiring Party) to have irrevocably ceded all
decision-making authority with respect to such Opt-Out Product to the
Non-Acquiring Party. In addition, if such Opt-Out Product is being marketed and
sold

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at the time of the closing of the Third Party Acquisition, then during the
Sanofi Termination Notice Period or Regeneron Termination Notice Period, as
applicable, the following shall apply:
(1) In any Quarter in which the U.S. Profits are positive, the U.S. Profit Split
shall be zero percent (0%) to the Acquiring Party and one hundred percent (100%)
to the Non-Acquiring Party, and in any Quarter in which the ROW Profits are
positive, the ROW Profit Split shall be zero percent (0%) to the Acquiring Party
and one hundred percent (100%) to the Non-Acquiring Party.
(2) In any Quarter, in which U.S. Profits are negative, the U.S. Profit Split
shall be one hundred percent (100%) to the Acquiring Party and zero percent (0%)
to the Non-Acquiring Party, and in any Quarter in which ROW Profits are
negative, the ROW Profit Split shall be one hundred percent (100%) to the
Acquiring Party and zero percent (0%) to the Non-Acquiring Party.
          (iii) Transfer of Rights. If the Acquiring Party chooses this
alternative, the Acquiring Party shall commit in writing to the Non-Acquiring
Party, within ten (10) Business Days after the closing of such Third Party
Acquisition, to license or otherwise transfer rights to such Acquired Competing
Product to a Third Party (without any consideration or payment to the
Non-Acquiring Party) and/or cease all development, manufacturing and/or
commercialization, as applicable, of such Acquired Competing Product within six
(6) months after the closing of the Third Party Acquisition, and shall do so
within such six (6) month period.
          (iv) Required Divestiture of Licensed Product. Notwithstanding any of
the foregoing in this Section 2.6(c), in the event the Acquiring Party believes,
based on the written advice of its counsel, that it is required by Law to divest
its interest either in the Acquired Competing Product or the Competing Licensed
Product, the Acquiring Party may terminate this Agreement with respect to such
Competing Licensed Product pursuant to Section 19.2(a) or 19.2 (b), as
appropriate, Section 2.6(c)(ii) and this Section 2.6(c)(iv), with regards to the
Competing Licensed Product, or transfer its interest in the Competing Licensed
Product pursuant to Section 2.6(c)(iii). If the Acquiring Party terminates this
Agreement with respect to the Competing Licensed Product pursuant to this
Section 2.6(c)(iv), it shall give the Non-Acquiring Party the maximum advance
notice (up to twelve (12) months) of termination consistent with such
divestiture requirement imposed by Law (the “Required Divestiture Notice
Period”), following which the provisions of 2.6(c)(ii) shall apply and the
Competing Licensed Product shall be an Opt-Out Product. During this period, the
Acquiring Party will reasonably cooperate (at the Acquiring Party’s sole cost
and expense) with the Non-Acquiring Party to enable the Non-Acquiring Party to
assume, within the Required Divestiture Notice Period, the continued
Development,

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Manufacture and Commercialization of such Opt-Out Product in the Field in the
Territory. The Acquiring Party shall also be responsible for, and shall promptly
pay upon demand, all reasonable costs and expenses incurred by the Non-Acquiring
Party in assuming such continued Development, Manufacture and Commercialization
of such Opt-Out Product to the extent such costs and expenses, other than
capital investments, would not have been incurred and/or would have been paid by
the Acquiring Party, absent such Acquiring Party’s termination with respect to
such Opt-Out Product pursuant to Section 19.2(a) or (b). For the avoidance of
doubt, if the Required Divestiture Notice Period is less than the twelve
(12) months required by Section 19.2, the Acquiring Party shall have continuing
payment obligations (though no performance obligations beyond those described
above) to the Non-Acquiring Party with respect to such Opt-Out Product for the
entire Sanofi Termination Notice Period (if Sanofi is the Acquiring Party) or
Regeneron Termination Notice Period (if Regeneron is the Acquiring Party).
          (d) Subject to the further provisions of this Section 2.6(d), in the
case of any Opt-Out Product, the non-terminating Party (the “Sole Developer”)
shall have the right to Develop and Commercialize such Opt-Out Product, unless
such Opt-Out Product is (or becomes) a Competing Opt-Out Product, in which case
the Sole Developer may not (either directly or through an Affiliate or Third
Party), Develop or Commercialize such Competing Opt-Out Product for a period of
******** following the date it becomes a Competing Opt-Out Product (or, if
shorter, such period ending on the date such Competing Opt-Out Product ceases to
be a Competing Opt-Out Product), unless otherwise agreed by the terminating
Party (the “Opt-Out Partner”). If an Opt-Out Product is Commercialized by the
Sole Developer (either directly or through an Affiliate or Third Party) in
compliance with this Section 2.6(d), then the Sole Developer shall pay the
Opt-Out Partner royalties based on Net Sales of such Opt-Out Product and the
stage of Development of the Licensed Product at the time it became an Opt-Out
Product, at the royalty rate(s) described on Exhibit A. Notwithstanding the
foregoing or any other provision of this Agreement, in the case of any Opt-Out
Product, including any Competing Opt-Out Product, resulting from termination of
this Agreement with respect to a Licensed Product pursuant to Section 19.2 in
the circumstances described in Section 2.6(c), the Sole Developer shall have no
obligation either to delay Developing or Commercializing, or to pay royalties
with respect to, such Opt-Out Product.
          (e) Clinical Trials for Combination Products. Notwithstanding anything
in this Section 2.6(e) to the contrary, each Party and/or its respective
Affiliates shall be entitled to (i) initiate, sponsor and/or conduct a clinical
trial and/or (ii) participate, directly or indirectly, whether through the
provision of funds, grants or otherwise, in any clinical trial, initiated,
sponsored and/or conducted by any Third Party, in each of the foregoing cases
with respect to the combination of any Party’s (or its Affiliate’s) product,
together with any Competing Product that has been granted a Marketing Approval
for at least one Indication in the applicable country, unless (A) a Licensed
Product Developed under this Agreement has been granted a Marketing Approval in
the applicable country for use in combination with such Party’s (or its
Affiliate’s) product in the same

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Indication(s) as the one to be studied in the intended clinical trial with the
Competing Product which is not approved in such Indication or (B) both the
Competing Product and a Licensed Product Developed under this Agreement have
been granted a Marketing Approval in the applicable country for use in
combination with such Party (or its Affiliate’s) product as the same Indication
to be studied in the intended clinical trial with the Competing Product and the
relevant labeling of both the Licensed Product and the Competing Product for
such Indication is substantially similar. For any combination study with a
Competing Product covered by this Section 2.6(e), the applicable Party shall
notify the other Party prior to initiating such trial, such notice to include a
brief synopsis of the protocol and a description of the Party’s (or its
Affiliate’s) role(s) and responsibilities in connection with the study. Further,
for any combination study with a Competing Product covered by this
Section 2.6(e), each Party shall promptly provide the other Party with available
results of such combination study, unless such disclosure is prohibited by Law
or contract. Each Party and/or its Affiliates shall be entitled to use data from
clinical trials permitted by this Section 2.6(e) to promote the combination of
such Party product together with such Competing Product, unless a Licensed
Product Developed has been granted a Marketing Approval in the applicable
country for use in combination with such Third Party product, in the same
Indication. Neither Party nor its respective Affiliates shall receive any
compensation or other payments (either in cash or in kind) based on the
development, promotion, or sale of a Competing Product. Neither Party will
intentionally delay the commencement, enrollment or completion of a clinical
study of a Licensed Product as a result of any ongoing or pending clinical trial
permitted by this Section 2.6(e). For the avoidance of doubt, neither Party nor
its respective Affiliates shall use or disclose any Party Information or New
Information subject to the confidentiality provisions of Article XVI in
connection with any of the activities described in this Section 2.6(e).
ARTICLE III
MANAGEMENT
     3.1 Committees/Management.
          (a) The Parties agree to establish, for the purposes specified herein,
a Joint Steering Committee (the “JSC”), a Joint Development Committee (the
“JDC”), a Joint Commercialization Committee (the “JCC”), CRCCs to the extent
provided in Section 3.5, and such other commercialization sub-committee as JCC
shall deem to be appropriate, a Joint Manufacturing Committee (“JMC”), a Joint
Finance Committee (the “JFC”) and such other Committees as the Parties deem
appropriate. The JSC, JDC, JFC and JMC shall each be established within thirty
(30) days after the Effective Date. The JCC shall be established at least two
(2) years prior to the anticipated filing date for Marketing Approval for the
first Licensed Product under this Agreement. The roles and responsibilities of
each Committee are set forth in this Agreement (or as may be determined by the
JSC for Committees established in the future and not described herein) and may
be further designated by the JSC. From time to time, each Committee may
establish working groups (each, a “Working Group”) to oversee particular
projects or

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activities, and each such Working Group shall be constituted and shall operate
as the Committee which establishes the Working Group determines.
          (b) Each of the Committees and the Executive Officers shall exercise
its decision-making authority hereunder in good faith and in a commercially
reasonable manner for the purpose of optimizing the commercial potential of and
financial returns from the Licensed Products in the Field in the Territory
consistent with Commercially Reasonable Efforts and without regard to any other
pharmaceutical product being developed or commercialized in the Field by or
through a Party or any of its Affiliates (the “Collaboration Purpose”). The
Parties acknowledge and agree that none of the Committees or the Executive
Officers shall have the power to amend any of the terms or conditions of this
Agreement, other than by mutual agreement of the Parties as set forth in
Section 20.5.
     3.2 Joint Steering Committee.
          (a) Composition and Purpose. The JSC shall have overall responsibility
for the oversight of the Collaboration. The purpose of the JSC shall be (i) to
review and approve the overall strategy for an integrated worldwide Development
program for each Licensed Product, including the Manufacture of Licensed
Products in the Field for use in activities under the Plans and for the
Commercialization of Licensed Products in the Field in the Territory; (ii) to
review the efforts of the Parties in performing their responsibilities under the
Plans and (iii) to oversee the Committees and resolve matters pursuant to the
provisions of Section 3.11 below on which such Committees are unable to reach
consensus. The JSC shall be composed of at least three (3) senior executives of
each Party; provided that the total number of representatives may be changed
upon mutual agreement of the Parties (so long as each Party has an equal number
of representatives). In addition, each Party shall appoint a senior
representative who possesses a general understanding of clinical, regulatory,
manufacturing and marketing issues to act as its Alliance Manager (“Alliance
Manager”) to the JSC. Each Alliance Manager shall be charged with creating and
maintaining a collaborative work environment within and among all Committees and
providing single-point communication for seeking consensus both within the
respective Party’s organization and with the other Party’s organization.
          (b) Specific Responsibilities. In addition to its overall
responsibility for overseeing the Collaboration, the JSC shall in particular
(i) annually review and approve the Global Development Plan(s) if any,
Manufacturing Plan(s), Global Commercialization Plan(s) and Country/Region
Commercialization Plan(s); (ii) at least semi-annually review the efforts of the
Parties in performing their respective Development and Commercialization
activities under the then-effective Plans; (iii) attempt in good faith to
resolve any disputes referred to it by any of the Committees and provide a
single-point of communication for seeking consensus regarding key global
strategy and Plan issues; (iv) establish sub-committees of the JSC, as the JSC
deems appropriate and (v) consider and act upon such other matters as are
specifically assigned to the JSC under this Agreement or otherwise agreed by the
Parties.

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     3.3 Joint Development Committee.
          (a) Composition and Purpose. The purpose of the JDC shall be (i) to
advise the JSC on the strategy for the worldwide Development of each Licensed
Product in the Field; (ii) to develop (or oversee the development of), review
and annually update and present to the JSC for approval the Global Development
Plan(s) (and related Global Development Budget(s)) and (iii) to oversee the
implementation of the Global Development Plan(s) and the Development operational
aspects of the Collaboration. The JDC shall be composed of at least three
(3) senior executives of each Party; provided that the total number of
representatives may be changed upon mutual agreement of the Parties (so long as
each Party has an equal number of representatives).
          (b) Specific Responsibilities. In particular, the JDC shall be
responsible for:
          (i) advising the JSC on the overall global Development strategy for
each Licensed Product in the Field;
          (ii) developing (or overseeing the development of), and updating at
least annually, the Global Development Plan(s) (and related Global Development
Budget(s)), as described in Sections 5.2 and 5.3, for final approval by the JSC;
          (iii) reviewing and overseeing the implementation of, and compliance
with, the Global Development Plan(s) (including the Global Development
Budget(s));
          (iv) developing forecasts for Clinical Supply Requirements to enable
the timely preparation of the Manufacturing Plan;
          (v) overseeing clinical and regulatory matters pertaining to Licensed
Products in the Field arising from the Plans, and reviewing and approving
protocols, statistical analysis plans, clinical study endpoints, clinical
methodology and monitoring requirements for clinical trials of Licensed Products
in the Field as contemplated under the Global Development Plan(s) and for
Non-Approval Trials;
          (vi) reviewing and approving proposed target Licensed Product labeling
and reviewing and, to the extent set forth herein, approving proposed changes to
product labeling with respect to Licensed Products in the Field in accordance
with Section 7.2;
          (vii) developing a target profile for each Licensed Product;
          (viii) facilitating an exchange between the Parties of data,
information, material and results relating to the Development of Licensed
Products in the Field;

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          (ix) formulating a life-cycle management strategy for Licensed
Products in the Field and evaluating new opportunities for new formulations,
delivery systems and improvements in concert with the JCC;
          (x) establishing a regulatory Working Group responsible for
overseeing, monitoring and coordinating the submission of Registration Filings
in countries in the Territory, including coordinating material communications,
filings and correspondence with Regulatory Authorities in the Territory in
connection with the Licensed Products in the Field;
          (xi) establishing a Working Group responsible for overseeing all basic
research activities for Licensed Products in the Field conducted under the
Global Development Plan(s); and
          (xii) considering and acting upon such other matters as specifically
assigned to the JDC under this Agreement or by the JSC.
     3.4 Joint Commercialization Committee.
          (a) Composition and Purpose. The purpose of the JCC shall be to
develop and propose to the JDC and JSC the strategy for the global
Commercialization of Licensed Products in the Field in the Territory, and to
oversee the implementation of the Global Commercialization Plans and the
Commercialization operational aspects of the Collaboration on a
country-by-country basis. The JCC shall be composed of at least two (2) senior
executives of each Party; provided that the total number of representatives may
be changed upon mutual agreement of the Parties (so long as each Party has an
equal number of representatives).
          (b) JCC Responsibilities. In particular, the JCC shall be responsible
for:
          (i) developing and proposing to the JSC the global strategy for the
Commercialization of each Licensed Product in the Field in the Territory;
          (ii) commencing no later than two (2) years prior to the Anticipated
First Commercial Sale anywhere in the Territory, (A) developing (or overseeing
the development of), and updating not less frequently than once per Contract
Year, the Global Commercialization Plan(s) and related Global Commercialization
Budget(s) on a country-by-country basis for final approval by the JSC and
(B) establishing, to the extent provided in Section 3.5, Country/Region
Commercialization Committees to establish Country/Region Commercialization Plans
(and related Country/Region Commercialization Budgets) and any updates thereto
and carry out the other activities described in Section 3.5;
          (iii) **************************************;

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          (iv) Establishing the trade dress for each Licensed Product,
consistent with the guidelines established by the JCC, in the applicable Major
Market Country;
          (v) developing forecasts for Commercial Supply Requirements for the
Territory to enable the timely preparation of the Manufacturing Plan(s) for
review by the JMC and approval by the JSC;
          (vi) for each Licensed Product, on a country-by-country basis for the
Major Market Countries, developing and updating, as necessary,
****************************************************;
          (vii) reviewing and overseeing compliance with the Global
Commercialization Plan (including the related Global Commercialization Budget),
and Country/Region Commercialization Plans (including the Country/Region
Commercialization Budgets), to the extent applicable, for each Licensed Product,
including ensuring that country specific launch plans are consistent with the
Marketing Guidelines, and reviewing and validating latest annual estimates for
the current calendar year compared to the Global Commercialization Budget and
Country/Region Commercialization Budgets;
          (viii) establishing or validating the number and position of Details
required to meet market and sales forecasts and their conversion into the
equivalent number of Detailing FTEs according to applicable weighting factors,
based upon sales force and market practices, on a country-by-country basis,
consistent, however, with the applicable Marketing Guidelines;
          (ix) for each Licensed Product, selecting a Product Trademark in
accordance with Section 11.2 and giving guidance on trade dress for such
Licensed Product;
          (x) determining the launch date for each Licensed Product on a
country-by-country basis in Major Market Countries;
          (xi) *************************;
          (xii) preparing short-term and long-term sales forecasts for each
Licensed Product on a country-by-basis for Major Market Countries and reviewing
such forecasts for the remaining countries;
          (xiii) ************************;
          (xiv) validating the contents, design and layout of packaging for each
Licensed Product in the Field;
          (xv) validating plans and policies regarding journal and other
publications with respect to each Licensed Product in the Field in concert with
the JDC;

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          (xvi) formulating a life-cycle management strategy for each Licensed
Product in the Field and evaluating new opportunities for new indications,
formulations, delivery systems and improvements in concert with the JDC;
          (xvii) matters relating to Regeneron’s Commitment Level with respect
to a Licensed Product in a Co-Commercialization Country, including consenting to
changes therein; and
          (xviii) considering and acting upon such other matters as specifically
assigned to the JCC under this Agreement or by the JSC, JDC JFCor JMC.
          3.5 Country/Region Commercialization Committees. The JCC will
establish a Country/Region Commercialization Committee in each Major Market
Country, and in each other Reporting Country/Region as and when determined by
the JCC. The Country/Region Commercialization Committees will be responsible for
establishing the Country/Region Commercialization Plans (and related
Country/Region Commercialization Budgets) and any updates thereto with respect
to the applicable Reporting Countries/Region(s). The Country/Region
Commercialization Committees will also serve as a forum to consider and discuss
and, if so empowered by the JCC, decide, in a more detailed and focused manner
with respect to the applicable Reporting Countries/Region(s), and make
suggestions or recommendations to the JCC with respect to, the matters referred
to in Section 3.4, as applicable, including the implementation of decisions with
respect thereto made by the JCC as contemplated by such Section 3.4.
          3.6 Joint Finance Committee. The JFC shall be responsible for
accounting, financial (including planning, reporting and controls) and funds
flow matters related to the Collaboration and this Agreement, including such
specific responsibilities set forth in Article IX and such other
responsibilities determined by the JSC. The JFC also shall respond to inquiries
from the JDC, the JMC and the JCC, as needed.
          3.7 Joint Manufacturing Committee. Working with the JDC and JCC, as
appropriate, the Joint Manufacturing Committee shall be responsible for
overseeing process development and Manufacturing activities, including preparing
and updating the Manufacturing Plan for approval by the JSC and carrying out
such other responsibilities set forth in Article VIII, process and technology
selection, process improvements and related intellectual property filing
strategy and obtaining a common process for manufacturing, recalls, market
withdrawals, and any other corrective actions related to any Licensed Product in
the Territory, and for any other matters specifically assigned to the JMC by the
JSC. For process development activities, the Joint Manufacturing Committee shall
consult the appropriate expert functions within both Parties or their Affiliates
as appropriate.
          3.8 Membership. Each of the Committees shall be composed of an equal
number of representatives appointed by each of Regeneron and Sanofi. Each Party
may replace its Committee members upon written notice to the other Party. Each
Committee will have two (2) co-chairpersons, one designated by each of Regeneron
and Sanofi. Each co-chairperson shall be

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entitled to call meetings. The co-chairpersons shall coordinate activities to
prepare and circulate an agenda in advance of the meeting and prepare and issue
final minutes within thirty (30) days thereafter.
          3.9 Meetings. Each Committee shall hold meetings at such times as the
Parties shall determine, but in no event less frequently than once every Quarter
during the Term, commencing from and after the time such Committee is
established as provided herein. If possible, the meetings shall be held in
person (to the extent practicable, alternating the site for such meetings
between the Parties or their Affiliates) or when agreed by the Parties, by video
or telephone conference. Other representatives of each Party or of Third Parties
involved in the Development, Manufacture or Commercialization of any Licensed
Product in the Field (under obligations of confidentiality) may be invited by
the Committee co-chairs to attend meetings of the Committees as nonvoting
participants. Each Party shall be responsible for all of its own expenses of
participating in the Committees. Either Party’s representatives on a Committee
may call a special meeting of the applicable Committee upon at least five
(5) Business Days’ prior written notice, except that emergency meetings may be
called with at least two (2) Business Days’ prior written notice.
          3.10 Decision-Making. The Committees shall operate by consensus. The
representatives of each Party shall have collectively one (1) vote on behalf of
such Party; provided that no such vote taken at a meeting shall be valid unless
a representative of each Party is present and participating in the vote.
Notwithstanding the foregoing, each Party, in its sole discretion, by written
notice to the other Party, may choose not to have representatives on a Committee
and leave decisions of such Committee(s) to representatives of the other Party.
          3.11 Resolution of Governance Matters. As provided in Section 10.2,
this Section 3.11 shall apply to matters constituting, or which if not resolved
would constitute, a Governance Dispute.
          (a) Generally. The Parties shall cause their respective
representatives on the Committees to use their Commercially Reasonable Efforts
to resolve all matters presented to them as expeditiously as possible, provided
that, in the case of any matter which cannot be resolved by the JDC, JCC, CRCC,
JMC, JFC or other relevant Committee established hereunder, at the request of
either Party, such matter shall promptly, and in any event within ten (10)
Business Days (or two (2) Business Day in the event of an urgent matter) after
such request, be referred to the JSC with a request for resolution.
          (b) Referral to Executive Officers. In the event that the JSC is,
after a period of five (5) Business Days from the date a matter is submitted to
it for resolution pursuant to Section 3.11(a), unable to make a decision due to
a lack of required unanimity, then either Party may require that the matter be
submitted to the Executive Officers for a joint decision. In such event, either
Party may, in a written notice to the other Party, formally request that the
dispute be resolved by the Executive Officers, specifying the nature of the
dispute with sufficient specificity to permit adequate consideration by such
Executive Officers. The Executive Officers shall diligently and in

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good faith, attempt to resolve the referred dispute within five (5) Business
Days of receiving such written notification, failing which,
***********************.
          (c) Notwithstanding the foregoing, and subject to Section 10.4, Legal
Disputes and disputes referred to in the third sentence of Section 2.6(b) which
involve a Technical Development Matter shall be referred to the Executive
Officers with no Party’s Executive Officer having final decision making
authority.
          (d) Interim Budgets. Pending resolution by the Executive Officers of
any referred dispute under Section 3.11(b) and subject to the terms of
Section 19.2, the Executive Officers shall negotiate in good faith in an effort
to agree to appropriate interim budgets and plans to allow the Parties to
continue to use Commercially Reasonable Efforts to Develop, Manufacture and
Commercialize the Licensed Products in the Field in the Territory pursuant to
this Agreement. The most recent Committee approved Plan(s) shall be extended
pending approval by the Executive Officers of the interim budget(s) and Plan(s)
referred to in this Section 3.11(c).
          (e) Obligations of the Parties. The Parties shall cause their
respective designees on the Committees and their respective Executive Officers
to take the actions and make the decisions provided herein to be taken and made
by such respective designees and Executive Officers in the manner and within the
applicable time periods provided herein. To the extent a Party performs any of
its obligations hereunder through any Affiliate of such Party, such Party shall
be fully responsible and liable hereunder and thereunder for any failure of such
performance, and each Party agrees that it will cause each of its Affiliates to
comply with any provision of this Agreement which restricts or prohibits a Party
from taking any specified action.
ARTICLE IV
LICENSE GRANTS
          4.1 Regeneron License Grants. Subject to the terms and conditions of
this Agreement (including, without limitation, Section 4.6) and any License to
which Regeneron is a party, Regeneron hereby grants to Sanofi (a) the
nontransferable (except as permitted by Section 20.9), co-exclusive (with
Regeneron and its Affiliates) right and license under the Regeneron Intellectual
Property to make, have made, use, develop and import Licensed Products for use
in the Field in the Territory, and (b) the nontransferable (except as permitted
by Section 20.9), exclusive (except as otherwise provided below in this
Section 4.1) right and license under the Regeneron Intellectual Property to sell
and offer to sell Licensed Products in the Field in the Territory, except that
the right and license granted pursuant to this clause (b) shall be co-exclusive
(with Regeneron and its Affiliates) to the extent of Regeneron’s right to
Co-Promote Licensed Products and Regeneron’s right to supply Licensed Products
to Sanofi, as contemplated by this Agreement. Sanofi will have the right to
grant sublicenses under the foregoing license only as set forth in Section 4.4.
          4.2 Sanofi License Grants. Subject to the terms and conditions of this
Agreement and any License to which Sanofi or any of its Affiliates is a party,
Sanofi hereby grants to Regeneron the nontransferable (except as permitted by
Section 20.9), royalty-free, co-

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exclusive (with Sanofi and its Affiliates) right and license under the Sanofi
Intellectual Property to the extent necessary to make, have made, use, develop
and import Licensed Products for use in the Field in the Territory and to
Co-Promote Licensed Products to the extent provided in this Agreement.
          4.3 Newly Created Intellectual Property. In addition to the other
licenses granted under this Article IV and subject to the other terms and
conditions of this Agreement, to the extent permitted under any relevant Third
Party agreement, each Party grants to the other Party and its Affiliates the
perpetual, royalty-free, paid-up, non-exclusive, worldwide right and license,
with the right to grant sublicenses, to use and practice for any and all
purposes: all intellectual property (including, without limitation, Know-How,
Patents and Patent Applications and copyrights), other than Know-How jointly
owned pursuant to Section 12.1(e) and other than Excluded Rights, discovered,
invented, authored or otherwise created by it (or its Affiliate) after the
Effective Date directly in connection with the performance of the research and
clinical activities approved by the JDC, in each case, as included in the Global
Development Plans. As used above, the term “Excluded Rights” shall mean any
Patents or Know-How claiming or covering composition (including any formulation)
of a Licensed Product. For the avoidance of doubt, nothing in this Section 4.3
shall be construed to grant either Party any license to Patents or Know-How of
the other Party discovered, invented, authored or otherwise created by it
outside the performance of the research activities approved by the JDC and/or
the clinical development activities approved by the JDC, in each case, as
included in Global Development Plans.
          4.4 Sublicensing. Unless otherwise restricted by any License, Sanofi
will have the right to sublicense any of its rights under the first sentence of
Section 4.1 only with the prior written consent of Regeneron, such consent not
to be unreasonably withheld or delayed with respect to rights outside the Major
Market Countries (and only with the prior written consent of Regeneron, which
consent may be withheld for any reason, in the Major Market Countries), except
that Sanofi may sublicense any of its rights hereunder to an Affiliate for
purposes of meeting its obligations under this Agreement without Regeneron’s
consent. Unless otherwise restricted by any License, Regeneron will have the
right to sublicense any of its rights under Section 4.2 with the prior written
consent of Sanofi, such consent not to be unreasonably withheld or delayed,
except that Regeneron may sublicense any of its rights hereunder to an Affiliate
for purposes of meeting its obligations under this Agreement without Sanofi’s
consent. Each Party shall remain responsible and liable for the compliance by
its Affiliates and Sublicensees with applicable terms and conditions set forth
in this Agreement. Any such sublicense agreement will require the Sublicensee of
a Party to comply with the obligations of such Party as contained herein,
including, without limitation, the confidentiality and non-use obligations set
forth in Article XVI, and will include, with respect to a Sublicensee of Sanofi,
an obligation of the Sublicensee to account for and report its sales of Licensed
Products to Sanofi on the same basis as if such sales were Net Sales by Sanofi.
For the avoidance of doubt, Regeneron shall be entitled to receive its share of
the applicable Profit Split based on Net Sales of Licensed Products sold by
Sublicensees under this Agreement. In the event of a breach by a Sublicensee of
any sublicense agreement which has or is reasonably likely to have an adverse
effect on either Party or any of its Affiliates or any Party’s Intellectual
Property, then the harmed Party may cause the other Party or its Affiliate to
exercise, and the other Party or its Affiliate will promptly exercise, any
termination rights it may have under the sublicense with the Sublicensee. Any

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sublicense agreement will provide for the termination of the sublicense or the
conversion of the sublicense to a license directly between the Sublicensee and
the other Party, at the option of the other Party, upon termination of this
Agreement. Furthermore, any such sublicense shall prohibit any further
sublicense or assignment. Each Party will forward to the other Party a complete
copy of each applicable fully executed sublicense agreement (and any
amendment(s) thereto) within ten (10) days of the execution of such agreement.
          4.5 No Implied License. Except as expressly provided in this
Article IV or elsewhere in this Agreement, neither Party will be deemed by this
Agreement to have been granted any license or other rights to the other Party’s
Patent Rights, Know-How, or Party Information either expressly or by
implication, estoppel or otherwise.
          4.6 Retained Rights. With respect to the licenses granted under this
Article IV, and for the avoidance of doubt, Regeneron expressly reserves for
itself and its Affiliates and Third Party licensees under the Regeneron
Intellectual Property and Regeneron’s interest in the Joint Inventions, the
right to Manufacture and to Commercialize Licensed Products for use in the Field
in the Territory in accordance with this Agreement. For the further avoidance of
doubt, Regeneron retains all rights in Regeneron Intellectual Property,
Regeneron’s interest in the Joint Inventions and Licensed Products not expressly
licensed hereunder, including, without limitation the right to exploit Regeneron
Intellectual Property and Regeneron’s interest in Joint Inventions for purposes
unrelated to the Licensed Products in the Field. With respect to the licenses
granted under this Article IV, and for the avoidance of doubt, Sanofi expressly
reserves for itself and its Affiliates and Third Party licensees under the
Sanofi Intellectual Property and Sanofi’s interest in the Joint Inventions, the
right to Manufacture and to Commercialize Licensed Products for use in the Field
in the Territory in accordance with this Agreement. For the avoidance of doubt,
Sanofi retains all rights in Sanofi Intellectual Property, Sanofi’s interest in
the Joint Inventions and Licensed Products not expressly licensed hereunder,
including, without limitation, the right to exploit Sanofi Intellectual Property
and Sanofi’s interest in Joint Inventions for purposes unrelated to the Licensed
Products in the Field.
ARTICLE V
DEVELOPMENT ACTIVITIES
5.1 Development of Licensed Products. Subject to the terms of this Agreement,
the Parties shall undertake Development activities with respect to Licensed
Products in the Field pursuant to the Global Development Plans under the general
direction and oversight of the JDC. Each Party shall use Commercially Reasonable
Efforts to Develop Licensed Products in the Field, carry out the Development
activities assigned to it in Development Plans in a timely manner and conduct
all such activities in compliance with applicable Laws, including, without
limitation, Good Practices.
5.2 Global Development Plans. With respect to each Licensed Product, the JDC
shall prepare and present a Global Development Plan for approval by the JSC, and
the JSC shall approve a Global Development Plan for such Licensed Product,
within three (3) months after the time such Licensed Product first becomes a
Licensed Product in accordance with the terms of the Discovery Agreement and
this Agreement, and shall, subject to the further provisions of this
Section 5.2, determine which Party will take the lead in the Development of

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such Licensed Product. Prior to such JSC approval of the first Global
Development Plan for any Licensed Product, the Parties shall Develop the
Licensed Product in accordance with the applicable Initial Development Plan,
including, in the case of REGN88 (IL-6RmAb), a summary outline of an Initial
Development Plan attached hereto as Exhibit B. An updated Global Development
Plan for such Licensed Product will be presented by the JDC for approval by the
JSC, and approved by the JSC, at least two (2) months prior to the end of each
Contract Year. Each Global Development Plan for a Licensed Product will set
forth the plan for Development of such Licensed Product in the Field over at
least three (3) Contract Years and will include (a) strategies and timelines for
Developing and obtaining Approvals for such Licensed Product in the Field in the
Territory, and (b) the allocation of responsibilities for Development activities
between the Parties, and/or Third Party service providers. Each Global
Development Plan will be reviewed and informally updated by the JDC not less
frequently than once every six (6) months for the ensuing three (3) year period.
Unless and to the extent otherwise agreed by the Parties with respect to a
particular Licensed Product, (i) the Parties shall alternate, on a Licensed
Product-by-Licensed Product basis, in being allocated principal responsibility
for formulating, and carrying out, the principal Development activities for the
applicable Licensed Product under the applicable Global Development Plan(s) from
the time the applicable Product Candidate is advanced into Development in
accordance with the Discovery Agreement (whereupon such Product Candidate
automatically constitutes a Licensed Product) through proof of concept as
defined in the Global Development Plan for the Licensed Product (the “POC Time”)
(with respect to any Licensed Product, the Party with such principal
responsibility through the POC Time being referred to as the “POC Principal
Party”) and (ii) the Parties shall alternate being allocated principal
responsibility for formulating, and carrying out, all clinical trials conducted
subsequent to the POC Time for the applicable Licensed Product(s) under the
applicable Global Development Plan(s) (with respect to a Licensed Product, the
Party with such principal responsibility being referred to as the “Post-POC
Principal Party”), with Sanofi being the Post-POC Principal Party for two (2),
and Regeneron being the Post-POC Principal Party for one (1), out of each three
(3) Licensed Products. The Parties shall cause their respective representatives
on the JDC and the JSC, in preparing, updating and approving Global Development
Plans, to allocate principal Development responsibilities thereunder as provided
in this Section 5.2.
          5.3 Global Development Budgets. Each Global Development Plan for a
Licensed Product shall include a related Global Development Budget (each
individually, a “Global Development Budget” and collectively, “Global
Development Budgets”) and each Global Development Budget shall be prepared,
updated, reviewed and approved as part of the preparation, update and approval
of the Global Development Plan of which such Global Development Budget is a part
in accordance with this Agreement. Amendments and updates to any Global
Development Budget shall not be effective without the approval of the JSC.
          5.4 Development Reports. Within forty-five (45) days after the end of
each Quarter, commencing in the first Quarter in which Development activities
commence hereunder with respect to the first Licensed Product, Regeneron and
Sanofi shall each provide to the other Party a written report (in electronic
form) summarizing the material activities undertaken by such Party during such
Quarter in connection with each Global Development Plan, together with a
statement of Development Costs incurred by such Party during such Quarter, which
statement shall detail those amounts to be included in the Consolidated Payment
Report for such Quarter

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and shall be in such form, format and of such level of detail as approved by the
JFC. At the next JSC meeting held following such forty-five (45) day period, the
JSC will approve the final Development Costs which will be used in calculating
the Global Development Balance.
          5.5 Review of Clinical Trial Protocols. The JDC will establish
procedures for the expeditious review of clinical trial protocols for the
Licensed Products submitted to the JDC by Regeneron pursuant to Section 2.6(b),
including, without limitation, pre-approval authorizations for Non-Approval
Trials.
          5.6 Regeneron Early Development Opt-Out. Within thirty (30) days of
the date that Sanofi exercises its Opt-In Rights with respect to any Licensed
Product thereby including such Licensed Product under this Agreement, Regeneron
shall have a one-time right to opt-out of the further Development of such
Licensed Product (such right of Regeneron, the “Regeneron Early Development
Opt-Out Right”, and each such Licensed Product as to which Regeneron has
exercised the Regeneron Early Development Opt-Out Right, an “Early Development
Opt-Out Product”) by delivering written notice of such opt-out (a “Regeneron
Early Opt-Out Notice”) to Sanofi. Effective immediately upon the delivery by
Regeneron to Sanofi of a Regeneron Early Opt-Out Notice with respect to a
Licensed Product, (i) such Licensed Product shall automatically constitute an
Early Development Opt-Out Product, (ii) the rights and licenses granted by
Regeneron to Sanofi hereunder with respect to such Early Development Opt-Out
Product shall automatically terminate, (iii) Sanofi and its Affiliates shall
have a worldwide, fully paid-up, royalty-free (other than for amounts payable to
Third Parties for any intellectual property or technology contributed to the
Discovery Program or the Collaboration by Regeneron), exclusive right and
license, with the right to sublicense unless otherwise restricted by any
License, under the Regeneron Intellectual Property existing at the time the
Regeneron Early Opt-Out Notice was delivered to Sanofi, to Develop, Manufacture
and Commercialize in the Field in the Territory (and solely to the extent that
such Regeneron Intellectual Property has, as of the date of the Regeneron Early
Opt-Out Notice, actually been incorporated into such Early Development Opt-Out
Product or otherwise claims or covers its use) the Early Development Opt-Out
Product with respect to which such Regeneron Early Development Opt-Out Notice
was delivered, (iv) *****************************, (v) Regeneron shall, as
promptly as reasonably practicable, transfer to Sanofi all clinical activities
related to the Early Development Opt-Out Product, (vi) except as set forth in
this Section 5.6, Regeneron shall have no further rights or obligations with
respect to such Early Development Opt-Out Product, (vii) Sanofi shall be free to
Develop and Commercialize such Early Development Opt-Out Product in the Field in
the Territory free of any obligations to Regeneron hereunder, except for
reimbursing Regeneron for any pass through costs to Third Party licensors of
Regeneron Intellectual Property, to the extent attributable to the Development
or Commercialization of Licensed Products by Sanofi, and (viii)
*************************. As used in clause (viii) immediately above,
“antibody” shall mean any actual or potential therapeutic or diagnostic antibody
(whether fully human, humanized, phage display, chimeric, polyclonal, or any
other type of antibody), or any derivative, or fragment thereof, including any
immunoconjugates or fusions comprising any such gene product, derivative or
fragment, and any composition or formulation that incorporates or includes any
of the foregoing. Except as provided in this Section 5.6, a Party’s obligations
under this Agreement with respect to the Development of a Licensed Product shall
terminate only upon termination of this Agreement

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with respect to such Licensed Product or in its entirety in accordance with, and
only to the extent and upon the terms and conditions set forth in, Article XIX.
ARTICLE VI
COMMERCIALIZATION
          6.1 Commercialization of Licensed Products in the Field in the
Territory. Subject to the terms of this Agreement, the Parties shall undertake
Commercialization activities with respect to Licensed Products in the Field in
the Territory under the direction and oversight of the JCC. Sanofi shall be the
lead Party with respect to the Commercialization of Licensed Products in the
Field. Sanofi shall use Commercially Reasonable Efforts to Commercialize
Licensed Products in the Field, and carry out the Commercialization activities
in accordance with the applicable Global Commercialization Plan and the
applicable Country/Region Commercialization Plans in a timely manner and conduct
all such activities in compliance with applicable Laws. Except as otherwise
provided in this Agreement, Sanofi shall bear all costs and expenses to
Commercialize the Licensed Products in the Field in the Territory. Sanofi or its
Affiliate shall invoice and book all sales of the Licensed Products in the Field
in the Territory and shall appropriately record all such sales. Sanofi or its
Affiliate shall also be responsible for the distribution of the Licensed
Products in the Field in the Territory and for paying all governmental rebates
which are due or owing with respect to the Licensed Products in the Field in the
Territory. Commencing with the initiation of Phase 3 Trials for a Licensed
Product in
the Field in the Territory, the Parties will commence regular ad hoc discussions
concerning the Commercialization strategy for the Licensed Product.
          6.2 Global Commercialization Plan(s). Each Global Commercialization
Plan and all updates and amendments thereto will be consistent with the
principles of the Collaboration Purpose. Each Global Commercialization Plan
shall be prepared by Sanofi (with assistance from Regeneron) at the direction of
the JCC, and submitted to the JCC for review and approval. Once approved by the
JCC, a Global Commercialization Plan will be presented to the JSC for review and
approval at least ***********************. Such Global Commercialization Plan
for each subsequent Contract Year shall be updated by the JCC and approved by
the JSC at least one (1) month prior to the end of the then current Contract
Year. The Global Commercialization Plan with respect to each Licensed Product
shall include (with sufficient detail, relative to time remaining to Anticipated
First Commercial Sale, to enable the JCC and JSC to conduct a meaningful review
of such Plan) information and formatting as will be agreed upon by the JCC,
including:
          (a) the overall global strategy for Commercializing such Licensed
Product in the Field in the Territory, including target product profiles,
branding, positioning, promotional materials and core messages for such Licensed
Product;
          (b) *******************************************;
          (c) the related Global Commercialization Budget;
          (d) anticipated launch dates for such Licensed Product for Major
Market Countries;

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          (e) market and sales forecasts for such Licensed Product in the Field
in the Territory in a form to be agreed between the Parties;
          (f) strategies for the detailing and promotion of such Licensed
Product in the Field in the Territory;
          (g) anticipated major advertising, public relations and patient
advocacy programs for such Licensed Product in the Field in the Territory;
          (h) Non-Approval Trials; and
          (i) all other Marketing Guidelines.
          6.3 Country/Region Commercialization Plans. Each Country/Region
Commercialization Plan and all updates and amendments thereto will be consistent
with the principles of the Collaboration Purpose. It is anticipated that each
Country/Region Commercialization Plan for each Licensed Product will be prepared
by Sanofi (with assistance from Regeneron in the U.S. and all
Co-Commercialization Countries), and approved by the JCC, at least
*****************. Such Country/Region Commercialization Plan for each
subsequent Contract Year shall be updated by the applicable Country/Region
Commercialization Committee, and approved by the JCC, at least two (2) months
prior to the end of the then current Contract Year. Each Country/Region
Commercialization Plan with respect to each Licensed Product shall include (with
sufficient detail, relative to time remaining to Anticipated First Commercial
Sale, to enable the JCC to conduct a meaningful review of such Plan) information
and formatting as will be agreed upon by the JCC, including the overall strategy
for Commercializing such Licensed Product, ***********, market and sales
forecasts, and estimated FTE and Shared Commercial Expenses. In those countries
where the Parties are Co-Promoting a Licensed Product, such Country/Region
Commercialization Plans shall include more detailed information on the
coordination of detailing and promotional efforts, including the estimated
number of detailing FTEs for each Party (based on the number and position of
Details required to meet the market and sales forecasts) and the specific
allocation of Co-Promotion efforts between the Parties.
          6.4 Commercialization Efforts; Sharing of Commercial Information.
          (a) Sanofi (through its Affiliates where appropriate) shall use
Commercially Reasonable Efforts to Commercialize Licensed Products in the Field
in the Territory in accordance with the Global Commercialization Plans, the
Marketing Guidelines and, as applicable, the Country/Region Commercialization
Plan(s). Without limiting the generality of the foregoing, (i) Sanofi will, as
necessary, build, train and apply a field force necessary to Commercialize the
Licensed Products in the Field in accordance with the applicable Global
Commercialization Plans and Country/Region

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Commercialization Plans, (ii) Sanofi’s, and in the Co-Commercialization
Countries each Party’s, sales representatives shall provide the FTE effort and
detail the Licensed Products in the Field in accordance with the approved
Country/Region Commercialization Plan (if applicable), Global Commercialization
Plan(s) and all applicable Laws.
          (b) Sanofi will provide Regeneron with full access to material
information directly relating to the Commercialization of each Licensed Product
in the Field, including, without limitation, information relating to anticipated
launch dates, key market metrics, market research, and sales. Without limiting
the foregoing, beginning in the Quarter of the First Commercial Sale in each
Major Market Country, Sanofi will provide Regeneron, and with respect to each
Co-Commercialization Country, Regeneron will provide Sanofi, on a quarterly
basis, with reports of the activity within its field force in each such Major
Market Country, which will include reasonable data from reports created by
Sanofi or Regeneron for its internal management purposes.
          (c) Each Party shall, on a periodic and reasonably current basis, keep
the other Party informed regarding major market developments, acceptance of the
Licensed Products in the Field, Licensed Product quality complaints and similar
information.
          (d) No Party may initiate or support any Non-Approval Trial for a
Licensed Product in the Field in the Territory without the prior approval of the
JDC.
          6.5 Co-Commercialization of Licensed Products.
          (a) Exercise of Co-Promote Option by Regeneron. In the event that
Regeneron desires to Co-Promote a Licensed Product in a particular country,
Regeneron shall notify Sanofi of (i) its preliminary indication of intent
regarding such Co-Promotion of such Licensed Product at least
************************* and (ii) its final decision regarding whether to
Co-Promote such Licensed Product in such country at
******************************. If Regeneron does not timely notify Sanofi of
its preliminary indication or of its final decision within the periods set forth
in clause (i) or (ii) above, as applicable, Regeneron shall not be entitled to
exercise its option to Co-Promote such Licensed Product in such country until on
or after the **************************************.
          (b) Co-Commercialization. Sanofi and Regeneron (through their
respective Affiliates where appropriate) shall Co-Commercialize Licensed
Products under the applicable Product Trademarks in each Co-Commercialization
Country in accordance with the then-current and applicable Country/Region
Commercialization Plan. Each Party shall use, or shall cause its local
Affiliates to use, Commercially Reasonable Efforts to Co-Commercialize the
Licensed Products in the Co-Commercialization Countries, and carry out the
activities assigned to it in the applicable Country/Region Commercialization
Plan. Each Party shall ensure that its Co-Commercialization activities conform
with the parameters in the applicable approved Country/Region Commercialization
Plan and the applicable Global Commercialization Plan.
          (c) Decision to Discontinue Co-Commercialization. In the event that
Regeneron decides it no longer wishes to Co-Commercialize a Licensed Product in
a

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particular Co-Commercialization Country or does not wish to maintain its minimum
sales force FTE requirement for Co-Commercialization of such Licensed Product in
such Co-Commercialization Country, provided that Regeneron has Co-Commercialized
Licensed Product and maintained its minimum sales force FTE requirement for
************** in such Co-Commercialization Country from the date it commences
Co-Promoting in such Co-Commercialization Country, Regeneron must give the JCC
and Sanofi ********** prior written notice of such decision. At the end of such
********* period, Regeneron shall cease all Co-Commercialization activities with
respect to such Licensed Product in such Co-Commercialization Country.
**************************.
          (d) Field Force Coordination. The JCC or the applicable Committee
shall coordinate the Co-Promotion of each Licensed Product by Sanofi, Regeneron,
their respective local Affiliates and their respective sales representatives in
each Co-Commercialization Country. The Parties will cooperate in the conduct of
such activities with respect to scheduling, geographical allocation, and
Professional or other customer targeting in order to optimize profits under the
applicable Country/Region Commercialization Plan. Without limiting the
generality of the foregoing, in each Co-Commercialization Country the Parties
will share and, to the extent appropriate, cooperate to implement consistent
policies and procedures with respect to the manner in which details and other
sales visits are conducted.
          (e) Co-Commercialization FTE Efforts.
          (i) FTE Efforts. Upon the exercise of its election pursuant to Section
6.5(a) to Co-Promote in a country, Regeneron will provide to Sanofi a binding
notice of the FTE effort that Regeneron commits to deliver in Co-Promoting such
Licensed Product in such country during the first (1st) Contract Year for which
Regeneron exercised its right to Co-Promote (the “Regeneron Commitment Level”).
Subject to the provisions of Section 6.4(e)(ii), if Regeneron elects to
Co-Promote a Licensed Product in a country, in no event shall the Regeneron
Commitment Level be less than ****************** of the total anticipated FTE
effort by both Parties (taken together) in Co-Promoting such Licensed Product in
such Co-Commercialization Country, unless otherwise agreed by the Parties. Such
FTE effort shall be based upon the forecasted number and position of Details
required to meet the market and sales forecasts in such Co-Commercialization
Country, and their conversion (by the JCC or applicable Country/Region
Commercialization Committee) into the equivalent number of Detailing FTEs
according to applicable weighting factors, based upon the sales force and
marketing practices in such Co-Commercialization Country. In no event shall the
Regeneron Commitment Level in Co-Promoting such Licensed Product in such
Co-Commercialization Country exceed ************ of the anticipated total FTE
effort by both Parties in Co-Promoting such Licensed Product in such
Co-Commercialization Country or such other maximum percentage agreed by the
Parties (the “Maximum Regeneron Effort”). Regeneron’s binding notice referred to
above in this Section 4(e)(i) shall be accompanied by a plan (which shall be
developed by Regeneron in cooperation

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with Sanofi and shall be intended to coordinate and integrate the Parties’
respective FTE efforts and detailing activities) for ensuring that Regeneron
will have in place a field force of qualified sales representatives to satisfy
the Regeneron Commitment Level. In each Co-Commercialization Country, Sanofi
shall perform the anticipated total FTE effort above the Regeneron Commitment
Level.
          (ii) Ophthalmology. In the event that a Licensed Product receives
Marketing Approval for an Indication related to ophthalmology, then, at
Regeneron’s option, Regeneron shall have the lead in the promotion of such
Licensed Product in such Indication, provided, however, that the limitations set
forth in Section 6.5(e)(i) shall apply.
          (f) Training. The Parties will coordinate sales force training efforts
in Co-Commercialization Countries and will share training materials (and conduct
joint training, where appropriate) to facilitate joint sales force training
efforts.
          (g) Samples. Sanofi shall provide Regeneron with Licensed Product
samples for use in Co-Commercialization Countries as required in the applicable
Country/Region Commercialization Plan. Sanofi and Regeneron (and their
respective Affiliates) shall use samples strictly in accordance with the
then-applicable approved Country/Region Commercialization Plan and shall store
and distribute samples in compliance with applicable Laws. Each Party (and its
local Affiliates) will maintain those records required by all applicable Laws
and shall allow representatives of the other Party to inspect such records and
storage facilities for the Licensed Product samples on request.
          6.6 Licensed Product Pricing and Pricing Approvals in the Territory.
**********************.
          6.7 Sales and Licensed Product Distribution in the Territory; Other
Responsibilities.
          (a) Sanofi (or its Affiliate) shall invoice and book, and
appropriately record, all sales of the Licensed Products in the Field in the
Territory. Sanofi (or its Affiliate) also shall be responsible for (i) the
distribution of Licensed Products in the Field in the Territory and for paying
all governmental rebates which are due and owing with respect to the Licensed
Products in the Field in the Territory, (ii) handling all returns of Licensed
Product sold under this Agreement and (iii) handling all aspects of ordering,
processing, invoicing, collection, distribution and receivables with respect to
Licensed Products in the Field in the Territory.
          (b) Sanofi (through its local Affiliates where appropriate), and with
respect to the Co-Commercialization Countries, Regeneron (through its local
Affiliates where appropriate), shall maintain records relating to its sales
representative FTEs for the Licensed Products in the Field in the countries in a
manner sufficient to permit the

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determination of Sales Force Cost and Medical Post-Approval Cost and the
incentive compensation requirements set forth in the Marketing Guidelines.
          6.8 Contract Sales Force. Each Party shall be entitled to engage a
Contract Sales Force for up to ********* of such Party’s Sales Force utilized
for any Licensed Product to discharge its annual FTE effort with respect to
Commercialization of such Licensed Product, provided that in the event that
Regeneron discontinues Co-Commercialization in a particular Co-Commercialization
pursuant to Section 6.5(c), then Sanofi shall be entitled to engage a Contract
Sales Force for more than ************** for that Co-Commercialization Country.
If a Party (or its local Affiliate) retains a Contract Sales Force, that Party
(or its local Affiliate) will be responsible for (i) all costs associated with
retaining such Contract Sales Force above approved Sales Force Costs included in
the applicable Country/Region Commercialization Budget and for the Contract
Sales Force’s compliance with this Agreement, including, without limitation, the
training and monitoring of such Contract Sales Force and ensuring compliance
with all applicable Laws, and (ii) ensuring that sales representatives in such
Contract Sales Force have minimum skill levels customary for sales
representatives in major pharmaceutical companies in such country in the
relevant therapeutic area.
          6.9 Promotional Materials.
          (a) Except as provided in and subject to Section 6.9(b): Sanofi will
be responsible, consistent with the Marketing Guidelines, the Global
Commercialization Plan and the Country/Region Commercialization Plans (as
applicable) and the decisions of the JCC with respect to Promotional Materials
as contemplated by Section 3.4(b)(vi), for the creation, preparation, production
and reproduction of all Promotional Materials and for filing, as appropriate,
all Promotional Materials with all Regulatory Authorities in the Territory,
except where Regeneron shall perform such responsibilities as the Lead
Regulatory Party. Upon request, Regeneron will have the right to review and
comment on all major Promotional Materials for use in any country in the
Territory prior to their distribution by Sanofi for use in the Territory.
          (b) The Parties and their Affiliates shall only use the Promotional
Materials and only conduct marketing and promotional activities for the Licensed
Products which, in each case, are approved by the JCC or the applicable
Country/Region Commercialization Committee if so delegated by the JCC for the
applicable Major Market Country. Sanofi shall ensure that Regeneron’s sales
representatives are provided with reasonable quantities of Promotional Materials
for use in a Co-Commercialization Country consistent with the Regeneron
Commitment Level for such Co-Commercialization Country in accordance with the
applicable approved Country/Region Commercialization Plan. All Promotional
Materials generated for a Co-Commercialization Country shall be maintained in
confidence and shall not be disclosed or distributed to Third Parties, until
such time as they have been reviewed and approved as set forth in this Section.
          (c) Sanofi shall own all rights to all Promotional Materials,
including all copyrights thereto, in the Major Market Countries.

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          6.10 Promotional Claims/Compliance. Neither Party nor any of its
Affiliates shall make any medical or promotional claims for any Licensed Product
in the Field other than as permitted by applicable Laws. When distributing
information related to any Licensed Product or its use in the Field in the
Territory (including information contained in scientific articles, reference
publications and publicly available healthcare economic information), each Party
and its Affiliates shall comply with all applicable Laws and any guidelines
established by the pharmaceutical industry in the applicable country.
          6.11 Restriction on Bundling in the Territory. If Sanofi or its
Affiliates or Sublicensees sell a Licensed Product in the Field in the Territory
to a customer who also purchases other products or services from any such
entity, Sanofi agrees not to, and to require its Affiliates and Sublicensees not
to, bundle or include any Licensed Product as part of any multiple product
offering or discount or price the Licensed Products in a manner that (a) is
reasonably likely to disadvantage a Licensed Product in order to benefit sales
or prices of other products offered for sale by a Party or its Affiliates to
such customer, (b) is inconsistent with the Collaboration Purpose or (c) would
result in pricing and discounting inconsistent with the applicable Marketing
Guidelines.
          6.12 Inventory Management. Sanofi shall use Commercially Reasonable
Efforts to manage Licensed Product inventory on hand at wholesalers and
Sublicensees so as to maintain levels of inventory appropriate for expected
demand and to avoid taking action that would result in unusual levels of
inventory fluctuation.
          6.13 Medical and Consumer Inquiries. The JCC shall establish
guidelines to handle medical questions or inquiries from consumers relative to
Licensed Products.
          6.14 Market Exclusivity Extensions. Each Party shall use Commercially
Reasonable Efforts to maintain, and, to the extent available, legally extend,
the period of time during which, in any country in the Territory, (a) a
Party(ies) has the exclusive legal right, whether by means of a Patent Right or
through other rights granted by a Governmental Authority in such country, to
Commercialize a Licensed Product in the Field in such country and (b) no generic
equivalent of a Licensed Product in the Field may be marketed in such country.
          6.15 Post Marketing Clinical Trials. Subject to the provision of this
Agreement, the Parties shall comply with any clinical trials obligations with
respect to a Marketing Approval with respect to any Licensed Product use in the
Field in any country in the Territory, imposed by applicable Law, pursuant to
the Approvals or required by a Regulatory Authority.
ARTICLE VII
CLINICAL AND REGULATORY AFFAIRS
          7.1 Ownership of Approvals and Registration Filings.
          (a) Unless otherwise agreed to by the Parties, the Post-POC Principal
Party shall be the Lead Regulatory Party and shall own (i) all Approvals with
respect to Licensed Product in the Territory and (ii) the IND for Licensed
Products during such time

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as it is the Post-POC Principal Party and shall have the rights and obligations
set forth in Sections 7.2 to 7.4 (inclusive) with respect thereto.
******************************.
          (b) The Lead Regulatory Party shall license, transfer, provide a
letter of reference with respect to, or take other action necessary to make
available the relevant Registration Filings and Approvals to and for the benefit
of the other Party.
          (c) The non-Lead Regulatory Party shall provide such assistance with
respect to regulatory matters as is reasonably requested by the Lead Regulatory
Party and consistent with the terms of this Agreement.
     7.2 Regulatory Coordination.
          (a) The Lead Regulatory Party shall oversee, monitor and coordinate
applicable regulatory actions, communications and filings with and submissions
(including supplements and amendments thereto) to each applicable Regulatory
Authority with respect to each Licensed Product in the Field in each
jurisdiction as to which it is the Lead Regulatory Party; provided that it shall
adhere to the obligations in this Article VII. Without limiting the foregoing,
the Lead Regulatory Party will be responsible for, and will use Commercially
Reasonable Efforts in applying for, obtaining and maintaining the applicable
Approval or other Registration Filing for each Licensed Product in the Field for
which it has responsibility as the Lead Regulatory Party. To the extent
applicable, the Lead Regulatory Party shall perform all such activities in
accordance with the Plans and all applicable Laws.
          (b) The Parties shall establish procedures, through the JDC or the
JCC, to ensure that the Parties exchange on a timely basis all necessary
information to enable the other Party and its licensees, as applicable, (i) to
comply with its regulatory obligations in connection with the Development,
Manufacture and/or Commercialization of the Licensed Products in the Field,
including, without limitation, filing updates or supplements with Regulatory
Authorities, pharmacovigilance filings, manufacturing supplements and
investigator notifications to Regulatory Authorities and (ii) to comply with
Laws in connection with the Development, Manufacture and/or Commercialization of
the Licensed Products in the Field anywhere in the Territory. The Parties shall
provide to each other prompt written notice of any Approval of a Licensed
Product in the Field anywhere in the world. The Parties shall work together
cooperatively through the JDC in the preparation of regulatory strategies and
with respect to all material regulatory actions, communications and Regulatory
Filings for Licensed Products in the Field in the Territory.
          (c) The Lead Regulatory Party shall use Commercially Reasonable
Efforts to provide the other Party as promptly as practicable with written
notice and copies of any material (i) draft filings with, (ii) submissions to
and (iii) correspondence (including Approvals) with, Regulatory Authorities
pertaining to the Development and/or Commercialization of a Licensed Product in
the Field under the Plans, and shall use reasonable efforts to afford the other
Party’s representatives an opportunity to actively participate in the drafting
and review of such material filings and submissions (including,

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without limitation, all annual and periodic safety reports for Licensed Products
in the Field), and consistent with applicable laws, to have up to two
(2) representatives from the other Party attend and actively participate in all
material, pre-scheduled meetings, telephone conferences and/or discussions with
Regulatory Authorities to the extent such material meetings, telephone
conferences and/or discussions pertain to the Development and/or
Commercialization of any Licensed Product in the Field. Without limiting the
foregoing, the Lead Regulatory Party shall use Commercially Reasonable Efforts
to provide the other Party on a timely basis with all material information, data
and materials reasonably necessary for the other Party to participate in the
preparation of the material filings and submissions referred to in this
paragraph (c), said items to be provided to the other Party in a timely manner.
The Parties will discuss in good faith any disputes on the contents of filings
or submissions referred to in this paragraph (c) to the Regulatory Authorities
and disputes shall be submitted to the JDC for timely resolution.
          (d) For each Licensed Product, the JDC shall develop and the JSC shall
approve proposed target Licensed Product labeling (“Target Labeling”) for use in
the Territory.
          7.3 Regulatory Events. Each Party shall keep the other Party informed,
commencing within forty-eight (48) hours after notification (or other time
period specified below), of any action by, or notification or other information
which it receives (directly or indirectly) from, any Regulatory Authority, Third
Party or other Governmental Authority, which:
          (a) raises any material concerns regarding the safety or efficacy of
any Licensed Product in the Field;
          (b) indicates or suggests a potential investigation or formal inquiry
by any Regulatory Authority in connection with the Development, Manufacture or
Commercialization of a Licensed Product in the Field under the Plans; provided,
however, that each Party shall inform the other Party of the foregoing no later
than twenty-four (24) hours after receipt of a notification referred to in this
clause (b); or
          (c) is reasonably likely to lead to a recall or market withdrawal of
any Licensed Product in the Field anywhere in the Territory.
          Information that shall be disclosed pursuant to this Section 7.3 shall
include, but not be limited to the following matters with respet to Licensed
Products:
          (i) Governmental Authority inspections of Manufacturing, Development,
distribution or other facilities;
          (ii) inquiries by Regulatory Authorities or other Governmental
Authorities concerning clinical investigation activities (including inquiries of
investigators, clinical research organizations and other related parties) or
pharmacovigilance activities, in each case, to the extent involving matters
described in clauses (a), (b) or (c) of this Section 7.3;

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          (iii) receipt of a warning letter issued by a Regulatory Authority;
          (iv) an initiation of any Regulatory Authority or other Governmental
Authority investigation, detention, seizure or injunction; and
          (v) receipt of product complaints concerning actual or suspected
Licensed Product tampering, contamination, or mix-up (e.g., wrong ingredients).
          7.4 Pharmacovigilance and Product Complaints. While the Lead
Regulatory Party shall be responsible for managing pharmacovigilance and product
complaints and for formulating and implementing any related strategies, both
Parties will cooperate with each other in order to fulfill all regulatory
requirements concerning pharmacovigilence and risk management plans and product
complaint reporting in all countries in which any Licensed Product is being
developed, manufactured, or commercialized anywhere in the Territory. Without
limitation to the foregoing, the Parties shall execute a Safety Data Exchange
Agreement (“SDEA”) setting forth the specific procedures to be used by the
Parties to coordinate the investigation and exchange of reports of adverse
events/adverse drug reactions and Licensed Product complaints to ensure timely
communication to Regulatory Authorities and compliance with Laws.
          7.5 Regulatory Inspection or Audit. If a Regulatory Authority desires
to conduct an inspection or audit of a Party with regard to a Licensed Product
in the Field, each Party agrees to cooperate with the other and the Regulatory
Authority during such inspection or audit, including by allowing, to the extent
practicable, a representative of the other Party to be present during the
applicable portions of such inspection or audit to the extent it relates to the
Development, Manufacture or Commercialization of a Licensed Product for use in
the Field under this Agreement. Following receipt of the inspection or audit
observations of the Regulatory Authority (a copy of which the receiving Party
will promptly provide to the other Party), the Party in receipt of the
observations will prepare any appropriate responses; provided that the other
Party, to the extent practicable, shall have the right to review and comment on
such responses to the extent they cover or may be reasonably expected to
adversely impact the Licensed Products in the Field in the Territory, and the
Party that received the observations shall consider in good faith the comments
made by such other Party. In the event the Parties disagree concerning the form
or content of a response, the Party that received the observations will decide
the appropriate form and content of the response. Without limiting the
foregoing, each Party (and its Third Party subcontractors) shall notify the
other Party within forty-eight (48) hours of receipt of a notification from a
Regulatory Authority of the intention of such Regulatory Authority to audit or
inspect facilities used or proposed to be used for the Manufacture of Licensed
Products for use in the Field under this Agreement; provided that such
notification shall be given no later than twenty-four (24) hours prior to any
such Regulatory Authority audit or inspection.
          7.6 Recalls and Other Corrective Actions. Decisions with respect to
any recall, market withdrawal or other corrective action related to any Licensed
Product in the Field in the Territory shall be made only upon mutual agreement
of the Parties, which agreement shall not be unreasonably withheld or delayed;
provided, however, that nothing herein shall prohibit either

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Party from initiating or conducting any recall or other corrective action
mandated by a Governmental Authority or Law. The Party that determines that a
recall or market withdrawal of a Licensed Product in the Field in the Territory
may be required shall, within twenty-four (24) hours, notify the other Party
and, without limitation of and subject to the proviso in the immediately
preceding sentence, the Parties shall decide whether such a recall or market
withdrawal is required. The Parties shall cooperate with respect to any actions
taken or public statements made in connection with any such recall or market
withdrawal. Expenses associated with such recalls will be treated as Other
Shared Expenses.
ARTICLE VIII
MANUFACTURING AND SUPPLY
          8.1 Manufacture and Supply of Clinical Supply Requirements of
Formulated Bulk Product. Until such time as Commercial Supply Requirements are
being Manufactured, Regeneron will use Commercially Reasonable Efforts to
provide an adequate and timely supply of Formulated Bulk Product for Clinical
Supply Requirements of Licensed Products in the Field in the Territory in
accordance with the Manufacturing Plan. Regeneron may use its Manufacturing
facilities or, subject to Sanofi’s prior written approval, such approval not to
be unreasonably withheld or delayed, Sanofi or Third Parties to Manufacture such
Formulated Bulk Product. If an entity other than Regeneron is to be used to
Manufacture Formulated Bulk Product for Clinical Supply Requirements, preference
shall be given to Sanofi or an Affiliate of Sanofi that is qualified to
Manufacture the applicable Licensed Product in accordance with applicable Good
Practices and where the estimated Manufacturing Cost is comparable to that of
Third Party Manufacturers. The Formulated Bulk Product Manufactured by or on
behalf of Regeneron for Clinical Supply Requirements will be billed to Sanofi by
Regeneron at the Manufacturing Cost per Part I of Schedule 1 as a Development
Cost. To the extent that Regeneron maintains manufacturing capacity available
for the Manufacture of Clinical Supply Requirements, the cost of maintaining
such capacity shall be included as a Development Cost to the extent it is not
included as a Manufacturing Cost.
          8.2 Finished Product Supply of Clinical Supply Requirements. Regeneron
will timely identify, and enter into an agreement with, a Third Party or Third
Parties or Sanofi (or use its own facilities, if Regeneron has such
capabilities) to perform the filling, packaging, labeling and testing of the
Formulated Bulk Product and supply Finished Product for Clinical Supply
Requirements for Licensed Products for use under this Agreement. If an entity
other than Regeneron is to be used to perform filling, packaging, labeling or
testing services related to Finished Product for Clinical Supply Requirements,
preference shall be given to Sanofi or an Affiliate of Sanofi that is qualified
to perform such services in accordance with applicable Good Practices and where
the estimated Manufacturing Cost is comparable to that of Third Parties. Such
Finished Product for Clinical Supply Requirements Manufactured on behalf of
Regeneron will be billed to Sanofi at the Manufacturing Cost as a Development
Cost, in accordance with Part I of Schedule 1.
          8.3 Manufacture and Supply of Commercial Supply Requirements.
     (a) The Parties, through the JMC and JSC, will determine whether a Party,
or a Third Party on behalf of a Party, will be responsible for Manufacturing and

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supplying Commercial Supply Requirements of Formulated Bulk Product and/or
Finished Product for each Licensed Product for use under this Agreement. The JMC
shall use all reasonable efforts to make such determination no later than
********************************. Such a notice (a “Manufacturing Notice”) shall
be irrevocable and shall be treated as a firm commitment to supply such
Formulated Bulk Product or Finished Product, as the case may be. Preference will
be given to having a Party or both Parties, rather than Third Parties,
Manufacture and supply Commercial Supply Requirements, provided that the Party
is qualified to Manufacture such Licensed Product in accordance with applicable
Good Practices and on terms mutually acceptable to the Parties. If both Parties
desire to Manufacture and supply such Commercial Supply Requirements,
**********************. If one Party desires to Manufacture and supply
******************************. If the Parties can not agree on terms under
which either or both Parties will Manufacture and supply Commercial Supply
Requirements of a Licensed Product, the JMC shall arrange for a Third Party to
Manufacture and supply such Commercial Supply Requirements.
     (b) Once Manufacture of Commercial Supply Requirements of a Licensed
Product begins, or is scheduled to begin, Manufacture of Clinical Supply
Requirements of such Licensed Product shall be coordinated with Manufacture of
Commercial Supply Requirements of such Licensed Product. Formulated Bulk Product
and/or Finished Product Manufactured by or on behalf of a Party for Commercial
Supply Requirements, and for Clinical Supply Requirements that are Manufactured
in coordination with the Commercial Supply Requirements, will be billed at the
Manufacturing Cost described in Part II of Schedule 1 as a Commercial Supply
Cost and Clinical Supply Cost, respectively. If a Party has commercial scale
capacity available in anticipation of beginning to Manufacture Commercial Supply
Requirements, the JMC shall decide if such Party shall Manufacture any Clinical
Supply Requirements even before it begins to Manufacture Commercial Supply
Requirements.
     (c) Any Third Party manufacturer of Commercial Supply Requirements or
Clinical Supply Requirements will be required to enter into a separate
confidentiality agreement with Regeneron prior to the transfer of the
manufacturing operations from Regeneron to such Third Party. All of Regeneron’s
costs and expenses associated with the transfer of the manufacturing operations
and related Know-How to the Third Party manufacturer (or Sanofi, to the extent
that Sanofi manufactures all or part of the Commercial Supply Requirements or
Clinical Supply Requirements) will be billed as a Development Cost.
          8.4 Supply Agreement. The Parties shall enter into one or more
clinical supply agreements with respect to the quality assurance/quality
control, forecasting, ordering and delivery of Clinical Supply Requirements,
which shall contain terms consistent with this Agreement. At least
************************* of a Licensed Product, the Parties shall enter into
separate commercial supply agreements with respect to the quality
assurance/quality control, forecasting, ordering and delivery of Clinical Supply
Requirements and Commercial Supply Requirements after the First Commercial Sale,
which shall contain terms consistent with this Agreement. Each supply agreement
will include as an annex thereto a customary quality

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agreement containing terms and conditions regarding quality assurance and Good
Practices and provide for terms for forecasting, ordering, delivery, payment and
supply consistent with the terms of this Agreement.
          8.5 Process Development and Manufacturing Plans. The Parties, through
the JMC, will develop and update as necessary, for each Licensed Product, a
Manufacturing Plan. The JMC shall be responsible for deciding on process and
technology selection, on process improvements and all related process
development activities which impact manufacturing. The JMC shall also be
responsible for all decisions relating to Manufacturing Formulated Bulk Product
for Clinical Supply Requirements of Licensed Products. Each Manufacturing Plan
shall set forth the supply requirements of a Licensed Product over an ensuing
period of at ***************. The Manufacturing Plan will include arrangements
for the Manufacture of back-up Formulated Bulk Product for Licensed Product
requirements at a Party or a Third Party back-up Manufacturing facility. The
Manufacturing Plan (including each annual update thereto) shall be prepared by
the JMC and approved by the JSC at least two (2) months prior to the end of the
then current Contract Year, except that the initial Manufacturing Plan covering
at least initial expected Clinical Supply Requirements for a Licensed Product,
to the extent not included in the Initial Development Plan, shall be approved by
the JSC within the initial Global Development Plan. The Parties shall design
Manufacturing Plans to ensure an adequate supply of Licensed Product and shall
use Commercially Reasonable Efforts to perform their responsibilities in
accordance with the approved Manufacturing Plans.
          8.6 Manufacturing Shortfall. Each Party is required to provide prompt
written notice to the other Party if it reasonably determines that it will not,
despite its using Commercially Reasonable Efforts, be able to supply the agreed
upon demand forecast for the Licensed Products set forth in the Manufacturing
Plan. Upon such notification, the matter will be referred to the JMC and JSC to
determine what, if any (and identify and establish, as quickly as possible, if
applicable) alternative supply source of Licensed Product (including the other
Party) should be utilized.
          8.7 Manufacturing Compliance. Each Party will use diligent efforts to
Manufacture the Formulated Bulk Product and Finished Product supplied under this
Article VIII or, as applicable, to ensure that the same is Manufactured by Third
Parties in conformity with Good Practices and applicable Laws. Each Party will
timely notify and seek the approval of the other Party, which approval shall not
be unreasonably withheld or delayed, for any Manufacturing changes for the
Formulated Bulk Product or Finished Product that are reasonably likely to have
an adverse impact on (a) the quality of the Licensed Products supplied under
this Agreement or (b) the regulatory status of the Licensed Products in the
Territory, including requirements to support or maintain any Approvals. Each
Party shall have the right to conduct inspections and audits of the other
Party’s facilities involved in the Manufacture of Licensed Products in the Field
pursuant to this Agreement at reasonable times and on reasonable prior notice on
terms to be agreed upon by the Parties. Moreover, each Party will use diligent
efforts to negotiate agreements that would allow the other Party to audit the
facilities of Third Party contractors (including Sanofi, if applicable) involved
in the Manufacture of Licensed Products for use in the Field under this
Agreement.

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ARTICLE IX
PERIODIC REPORTS; PAYMENTS
          9.1 Development Costs. Sanofi shall be responsible for paying one
hundred percent (100%) of the total Development Costs for each Licensed Product
incurred by or on behalf of Sanofi, Regeneron and their respective Affiliates,
except that Shared Phase 3 Trial Costs will be shared eighty percent (80%) by
Sanofi and twenty percent (20%) by Regeneron.
****************************************.
          9.2 Milestone Payments. In addition to the other payments contemplated
herein, Sanofi shall be obligated to pay the non-refundable, non-creditable
milestone payments listed in Schedule 3 to Regeneron upon the occurrence of the
applicable milestone event. Sanofi shall have thirty (30) Business Days after
the achievement of any such milestones to pay the corresponding amount to
Regeneron, in each case, which shall not be reduced by any withholding or
similar taxes.
          9.3 Royalties. Any royalty amounts payable pursuant to Section 2.6(d)
and 5.6 of this Agreement shall be paid to the applicable Party for the period
of time, as determined on an Opt-Out Product-by-Opt-Out Product and
country-by-country basis, commencing on the first commercial sale of such
Opt-Out Product and ****************** (the “Royalty Term”). During the Royalty
Term, the paying Party shall deliver to the other Party with each royalty
payment a report detailing in reasonable detail the information necessary to
calculate the royalty payments due under this Section 9.3 for such calendar
quarter, including the following information, specified on an Opt-Out
Product-by-Opt-Out Product and country-by-country basis: (a) total gross
invoiced amount from sales of each such Opt-Out Product by the paying Party, its
Affiliates and sublicensees; (b) all relevant deductions from gross invoiced
amounts to calculate Net Sales; (c) Net Sales; and (d) royalties payable.
          9.4 Sharing of Profits from Licensed Products. Commencing on the
Effective Date and continuing during the Term, the Parties shall share the U.S.
Profit Split in the United States, and (ii) the Rest of World Profit Split in
the Rest of World Countries, in each case, as described in Schedule 2.
          9.5 Periodic Reports. Sanofi and Regeneron shall each prepare and
deliver to the other Party the periodic reports specified below:
          (a) Each Party shall deliver electronically the reports required to be
delivered by it pursuant to Section 5.4;
          (b) Within twenty (20) days following the end of each month,
commencing with the month in which First Commercial Sale occurs, Sanofi shall
deliver electronically to Regeneron a monthly detailed Net Sales report with
monthly and year-to-date sales for each Licensed Product in the Field in the
Territory by country in United States Dollars;
          (c) Within forty-five (45) days following the end of each Quarter,
commencing with the Quarter in which First Commercial Sale occurs, Sanofi shall

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deliver electronically to Regeneron a written report setting forth, on a
country-by-country basis in the Territory for such Quarter (i) the Net Sales of
each Licensed Product in local currency and in United States Dollars,
(ii) Licensed Product quantities sold in the Field by dosage form and unit size
and (iii) gross Licensed Product sales in the Field and an accounting of the
deductions from gross sales permitted by the definition of Net Sales;
          (d) Within forty-five (45) days following the end of each Quarter,
each Party that has incurred any Other Shared Expenses or Shared Commercial
Expenses in that Quarter shall deliver electronically to the other Party a
written report setting forth in reasonable detail the Other Shared Expenses
and/or Shared Commercial Expenses incurred by such Party in such Quarter on a
country-by-country and Licensed Product-by-Licensed Product basis, including
whether any such expenses are also included in the reports delivered pursuant to
clause (e) below;
          (e) Within forty-five (45) days after the end of each Quarter,
commencing with the Quarter in which First Commercial Sale in a Reporting
Country/Region occurs (or such earlier agreed upon calendar Quarter, if
appropriate), Sanofi shall provide to Regeneron, in electronic form, for each
Reporting Country/Region, and Regeneron shall provide to Sanofi, in electronic
form, for each Co-Commercialization Country, a report summarizing in reasonable
detail the marketing, detailing, selling and promotional activities undertaken
by a Party (or its Affiliates) during the previous Quarter in such
Reporting/Country Region and/or Co-Commercialization Country; and
          (f) Within sixty (60) days following the end of each Quarter, Sanofi
shall deliver electronically to Regeneron a Consolidated Payment Report in
respect of such Quarter, combining the information reported by each Party
pursuant to this Article IX and showing its calculations in accordance with
Schedule 2 of the amount of any payments to be made by the Parties hereunder for
such Quarterly period as contemplated by Section 9.5 (including, as applicable,
showing the calculation of the U.S. Profit Split and Rest of World Profit Split)
and, if applicable, providing for the netting of such payments.
     All reports referred to in this Section 9.5 shall be in such form, format
and level of detail as may be approved by the JFC. Unless otherwise agreed by
the JCC, the financial data in the reports will include calculations in local
currency and United States Dollars.
          9.6 Funds Flow. The Parties shall make Quarterly True-Up payments as
set forth in Schedule 2. If Sanofi is the Party owing the Quarterly True-Up
payment based on the calculations in the applicable Consolidated Payment Report,
it shall, subject to Section 9.12, make such payment to Regeneron within fifteen
(15) days after its delivery to Regeneron of such Consolidated Payment Report.
If Regeneron is the Party owing the Quarterly True-Up payment based on the
calculations in the applicable Consolidated Payment Report, it shall, subject to
Section 9.12, make such payment to Sanofi within fifteen (15) days after its
receipt of such Consolidated Payment Report from Sanofi. Notwithstanding the
foregoing, no later than fifty-five (55) days after the end of each Quarter,
Sanofi shall pay Regeneron fifty percent (50%) of the amount of royalties or
other amounts payable under any License (to the extent attributable to

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the Manufacture, Development and/or Commercialization of Licensed Products under
the Plans for the Territory) to which Regeneron is a party on account of the
Commercialization of Licensed Products in the Field in the Territory and provide
such supporting documentation required by such License, as the case may be.
          9.7 Invoices and Documentation. The JFC shall approve the form of any
necessary documentation relating to any payments hereunder so as to afford the
Parties appropriate accounting treatment in relation to any of the transactions
or payments contemplated hereunder.
          9.8 Payment Method and Currency. All payments under this Agreement
shall be made by bank wire transfer in immediately available funds to an account
designated by the Party to which such payments are due. All sums due under this
Agreement shall be payable in United States Dollars. In those cases where the
amount due in United States Dollars is calculated based upon one or more
currencies other than United States Dollars, such amounts shall be converted to
United States Dollars using the average of the buying and selling exchange rates
for conversion of the applicable foreign currency into United States Dollars,
using the spot rates (the “Closing Mid-Point Rates” found in the “Dollar spot
forward against the Dollar” table published by The Financial Times, or any other
publication as agreed to by the Parties) from the last Business Day of the
preceding month.
          9.9 Late Payments. The Parties agree that, unless otherwise mutually
agreed by the Parties or otherwise provided in this Agreement, amounts due by
one Party to the other shall be payable to a bank account, details of which are
to be communicated by the receiving Party. All late payments under this
Agreement shall earn interest, to the extent permitted by applicable Law, from
the date due until paid at a rate equal to the thirty (30) day London Inter-Bank
Offering Rate (LIBOR) U.S. Dollars, as quoted in The Wall Street Journal
(Eastern Edition) effective for the date on which the payment was due, plus
********** (such sum being referred to as the “Default Interest Rate”).
          9.10 Taxes. Except as set forth in Section 9.2, any withholding or
other taxes that either Party or its Affiliates are required by Law to withhold
or pay on behalf of the other Party, with respect to any payments to such other
Party hereunder, shall be deducted from such payments and paid to the
appropriate tax authority contemporaneously with the remittance to the other
Party; provided, however, that the withholding Party shall promptly furnish to
the other Party proper evidence or other reasonable documentation of the taxes
so paid. Each Party shall cooperate with the other and furnish to the other
Party appropriate documents to secure application of the most favorable rate of
withholding tax under applicable Law (or exemption from such withholding tax
payments, as applicable). Without limiting the foregoing, each Party agrees to
make all lawful and reasonable efforts to minimize any such taxes, assessments
and fees and will claim on the other Party’s behalf the benefit of any available
treaty on the avoidance of double taxation that applies to any payments
hereunder to such other Party.
          9.11 Adjustments to FTE Rates. Notwithstanding anything herein to the
contrary, upon the request of either Party, the Parties shall meet to review the
accuracy of an applicable FTE rate in any country (e.g., Sales Force FTE Rate,
Medical Post-Approval FTE Rate, Development FTE Rate, etc.). The Parties agree
to share reasonable supporting documents

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and materials in connection with an assessment of the applicable FTE rate and to
determine in good faith whether to adjust the rate(s) in any country.
          9.12 Resolution of Payment Disputes. In the event there is a dispute
relating to any of the payment obligations or reports under this Article IX, the
Party with the dispute shall have its representative on the JFC provide the
other Party’s representative on the JFC with written notice setting forth in
reasonable detail the nature and factual basis for such good faith dispute and
the Parties, through the JFC, will seek to resolve the dispute as promptly as
possible, but no later than ten (10) days after such written notice is received.
In the event that no resolution is reached by the JFC, the matter shall be
referred to the JSC in accordance with Section 3.11(a). Notwithstanding any
other provision of this Agreement to the contrary, the obligation to pay any
reasonably disputed amount shall not be deemed to have been triggered until such
dispute is resolved hereunder, provided that all amounts that are not in dispute
shall be paid in accordance with the provisions of this Agreement.
ARTICLE X
DISPUTE RESOLUTION
          10.1 Resolution of Disputes. The Parties recognize that disputes as to
certain matters may from time to time arise which relate to either Party’s
rights and obligations hereunder. It is the objective of the Parties to comply
with the procedures set forth in this Agreement and to use all reasonable
efforts to facilitate the resolution of such disputes in an expedient manner by
mutual agreement.
          10.2 Governance Disputes. Disputes, controversies and claims related
to matters intended to be decided within the governance provisions of this
Agreement set forth in Article III (“Governance Disputes”) shall be resolved
pursuant to Article III and, to the extent such matters constitute Technical
Development Matters, a dispute referred to in Section 14.2(b) or a Budget
Dispute, Section 10.4, except to the extent any such dispute, controversy or
claim constitutes a Legal Dispute, in which event the provisions of Section 10.3
shall apply. For the purposes of this Agreement, the term “Technical Development
Matter” shall mean any dispute concerning a Party’s refusal to approve a
clinical trial proposed pursuant to Section 2.6(b).
          10.3 Legal Disputes. The Parties agree that, subject to Sections 10.5
and 16.2, they shall use all reasonable efforts, through their participation in
the JSC in the first instance, to resolve any Legal Dispute arising after the
Effective Date by good faith negotiation and discussion. In the event that the
JSC is unable to resolve any such Legal Dispute within five (5) Business Days of
receipt by a Party of notice of such Legal Dispute, either Party may submit the
Legal Dispute to the Executive Officers for resolution. In the event the
Executive Officers are unable to resolve any such Legal Dispute within the time
period set forth in Section 3.11(b), the Parties shall be free to pursue any
rights and remedies available to them at law, in equity or otherwise, subject,
however, to Section 20.1 and Section 20.15.
          10.4 Expert Panel.
     (a) In the event of a dispute between the Parties concerning a Technical
Development Matter, any Budget Dispute or a dispute referred to in Section

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14.2(b) that cannot be resolved by the Executive Officers pursuant to
Section 3.11(b) (other than a Legal Dispute), either Party may by written notice
to the other Party require the specific issue in dispute to be submitted to a
panel of experts (“Expert Panel”) in accordance with this Section 10.4 (for the
avoidance of doubt, it is understood that, subject to Section 10.4(e), in the
case of a Budget Dispute first submitted to the Expert Panel, the specific issue
shall be limited to the overall commercial reasonableness of the Disputed
Budget). Such notice shall contain a statement of the issue forming the basis of
the dispute, the position of the moving Party as to the proper resolution of
that issue and the basis for such position. Within fifteen (15) days after
receipt of such notice, the responding Party shall submit to the moving Party a
statement of its conception of the specific issue in question, its position as
to the proper resolution of that issue and the basis for such position.
     (b) Within fifteen (15) days of the responding Party’s response, each Party
shall appoint to the Expert Panel an individual who (i) has expertise in the
pharmaceutical or biotechnology industry and the specific matters at issue (or,
in the case of a dispute regarding an audit as referred to in Section 14.2(b),
expertise in accounting and auditing with respect to the development and
commercialization of pharmaceutical products), (ii) is not a current or former
director, employee or consultant of such Party or any of its Affiliates, or
otherwise has not received compensation or other payments from such Party (or
its Affiliates) for the past five (5) years and (iii) has no known personal
financial interest or benefit in the outcome or resolution of the dispute, and
the appointing Party shall give the other Party written notice of such
appointment; provided that for such appointment to be effective and for such
individual to serve on the Expert Panel, such individual must deliver to the
other Party a certificate confirming that such individual satisfies the criteria
set forth in clauses (i) through (iii) above, disclosing any potential conflict
or bias and certifying that, as a member of the Expert Panel, such individual is
able to render an independent decision.
     (c) Within fifteen (15) days of the appointment of the second (2nd) expert,
the two (2) appointed experts shall agree on an additional expert who meets the
same criteria as described above, and shall appoint such expert as chair of the
Expert Panel. If the Party-appointed experts fail to timely agree on a third
(3rd) expert, then upon the written request of either Party, each
Party-appointed expert shall, within ten (10) days of such request, nominate one
expert candidate and the CPR Institute for Dispute Resolution shall, within ten
(10) days of receiving the names of the Parties’ respective nominees, select one
of those experts to serve as the chair of the Expert Panel. Each expert shall
agree, prior to his or her appointment, to render a decision as soon as
practicable after the appointment of the full Expert Panel.
     (d) Within seven (7) days of the appointment of the third (3rd) expert, the
Expert Panel shall hold a preliminary meeting or teleconference with the Parties
or their representatives and shall designate a time and place for a hearing of
the Parties on the dispute and the procedures to be utilized at the hearing. The
Parties may agree in writing to waive the hearing and have the Expert Panel
reach a decision on the basis of written submissions alone. The Expert Panel may
order the Parties to produce any documents or

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documents or information which are relevant to the dispute. All such documents
or information shall be provided to the other Party and the Expert Panel as
expeditiously as possible but no later than one (1) week prior to the hearing
(if any), along with the names of all witnesses who will testify at the hearing
and a brief summary of their testimony. The hearing shall be held in New York,
NY, unless otherwise agreed by the Parties, and shall take place as soon as
possible but no more than forty-five (45) days after the appointment of the
third expert, unless the Parties otherwise agree in writing or the Expert Panel
agrees to extend such time period for good cause shown. The hearing shall last
no more than one (1) day, unless otherwise agreed by the Parties or the Expert
Panel agrees to extend such time period for good cause shown. After the
conclusion of all testimony (or if no hearing is held after all submissions have
been received from the Parties), at a time designated by the Expert Panel no
later than seven (7) days after the close of the hearing or the receipt of all
submissions, each Party shall simultaneously submit to the Expert Panel and
exchange with the other Party its final proposed resolution (which, in the case
of a Budget Dispute first submitted to the Expert Panel shall be a Party’s
proposed resolution that the Disputed Budget either is or is not overall
commercially reasonable).
          (e) In rendering the final decision with respect to a Budget Dispute
first submitted to the Expert Panel, the Expert Panel shall be limited to
determining the overall commercial reasonableness of the Disputed Budget. If the
Expert Panel determines that such Disputed Budget is overall commercially
reasonable, then such Budget Dispute shall be deemed finally resolved and such
resolution shall be binding on the Parties. However, if the Expert Panel
determines that such Disputed Budget is not overall commercially reasonable,
then the Expert Panel shall, within fifteen (15) days after such determination,
render a final decision as to what modifications could be made to such Disputed
Budget in order for it to be overall commercially reasonable (a “Budget
Modification Decision”). In connection with reaching a Budget Modification
Decision, the Expert Panel shall order the Parties to produce any documents or
other information which are relevant to such final decision, and the Parties
shall submit such documents or other information, together with their respective
proposed resolutions which shall consist of their respective proposed
modifications to the Disputed Budget in order for it to be overall commercially
reasonable, at least seven days prior to the date a Budget Modification Decision
is required to be rendered as provided above. In rendering the final decision
(which, for other than a Budget Modification Decision, shall be rendered no
later than fifteen (15) days after receipt by the Expert Panel of the Parties’
respective proposed resolutions, and for a Budget Modification Decision, shall
be rendered no later than seven days after receipt by the Expert Panel of the
Parties’ respective proposed resolutions), the Expert Panel shall be limited to
choosing a resolution proposed by a Party without modification; provided,
however, that in no event shall the Expert Panel render a decision that is
inconsistent with the Collaboration Purpose and the Parties’ intentions as set
forth in this Agreement. The agreement of two (2) of the three (3) experts shall
be sufficient to render a decision and the Parties shall abide by such decision.
          (f) The decision of the Expert Panel shall be final and binding on the
Parties and may be entered and enforced in any court having jurisdiction. Each
Party

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shall bear the cost of its appointee to the Expert Panel and the Parties shall
share equally the costs of the third expert.
          10.5 No Waiver. Nothing in this Article X or elsewhere in this
Agreement shall prohibit either Party from seeking and obtaining immediate
injunctive or other equitable relief if such Party reasonably believes that it
will suffer irreparable harm from the actions or inaction of the other.
ARTICLE XI
TRADEMARKS AND CORPORATE LOGOS
          11.1 Corporate Names. Each Party and its Affiliates shall retain all
right, title and interest in and to their respective corporate names and logos.
          11.2 Selection of Product Trademarks. For each Licensed Product, the
JCC shall select one Product Trademark for use in the Field throughout the
Territory, unless such Product Trademark is prohibited by law in any country in
the Territory or the JCC determines that a different Product Trademark should be
used in particular countries or Regions to maximize the commercial potential of
such Licensed Product. Once a Product Trademark has been selected by the JCC,
the Parties shall enter into an agreement or, in the alternative, shall amend
this Agreement as the Parties may agree, in order to address the Parties’
respective rights and obligations with respect to such Product Trademark. Each
Licensed Product in the Field shall be promoted and sold in the Territory under
the applicable Product Trademark(s), trade dress and packaging approved by the
JCC.
          11.3 Ownership of Product Trademarks. Unless otherwise mutually agreed
between the Parties, and subject to Sections 11.4 and 11.5, Sanofi (or its local
Affiliates, as appropriate) shall own and retain all right, title and interest
in and to Product Trademark(s), together with all associated domain names and
all goodwill related thereto in all countries in the Territory.
          11.4 Prosecution and Maintenance of Product Trademark(s). Sanofi will
use Commercially Reasonable Efforts to prosecute and maintain the Product
Trademark(s) in all countries in the Territory. Notwithstanding the foregoing,
in the event Sanofi elects not to prosecute or maintain any Product Trademark(s)
in any country in the Territory, Sanofi shall provide reasonable prior written
notice to Regeneron of its intention not to prosecute or maintain any such
Product Trademark in such country in the Territory, and Regeneron shall have the
right to do so on behalf of Sanofi for use with Licensed Products, subject to
consultation and cooperation with Sanofi. All Out-of-Pocket Costs incurred in
the filing, prosecution and maintenance of Product Trademarks as provided in
this Section 11.4 shall be shared by the Parties as part of Shared Commercial
Expenses.
          11.5 License to the Product Trademark(s). Sanofi hereby grants to
Regeneron a co-exclusive license (non-exclusive only with respect to Regeneron)
to use the Product Trademark(s) for the Licensed Products solely for the
purposes of Regeneron’s Development, Manufacturing, and, if applicable,
Co-Promotion of Licensed Products, or other Regeneron Commercialization
activities with respect to Licensed Products if agreed to by Sanofi or set forth

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in any Plans, subject to the terms and conditions of this Agreement. Consistent
with Section 4.4 of this Agreement, neither Party shall license (or in the case
of Regeneron, sublicense) rights to use, or otherwise transfer ownership of the
Product Trademark(s) without the prior written consent of the other Party, such
consent not to be unreasonably withheld or delayed. Sanofi shall only utilize
the Product Trademark(s) on approved Promotional Materials, on the Licensed
Products as needed and on or other approved product-related materials for the
Licensed Products in the Field in the Territory for the purposes contemplated
herein, and all use by Sanofi or its Affiliates or Sublicensees of the Product
Trademark(s) shall be in accordance with (a) rules established by the JCC and
(b) quality standards established by the JCC which are reasonably necessary in
order to preserve the validity and enforceability of the Product Trademark(s).
Each Party agrees that at no time during the Term will it or any of its
Affiliates attempt to use or register any trademarks, trade dress, service
marks, trade names or domain names confusingly similar to the Product
Trademark(s) in relation to a product that is a Licensed Product, or take any
other action which damages or dilutes the rights to, or goodwill associated
with, the Product Trademark(s). Upon request by either Party, the other Party
shall (or shall cause its Affiliates, as appropriate, to) execute such documents
as may reasonably be required for the purpose of recording with any Governmental
Authority the license, or a recordable version thereof, referred to above in
this Section 11.5.
          11.6 Use of Corporate Names. Sanofi (through its Affiliates, as
appropriate) shall use Commercially Reasonable Efforts to include Regeneron’s
name with equal prominence on materials related to each Licensed Product in the
Field (including, without limitation, package inserts, packaging, trade
packaging, samples and all Promotional Materials used or distributed in
connection with such Licensed Product), unless to do so would be prohibited
under applicable Laws; provided, however, in the case of multi-product materials
that refer to a Licensed Product in the Field as well as other pharmaceutical
products, the prominence of Regeneron’s name shall be commensurate with the
relative prominence of the Licensed Product in such materials. Each Party grants
to the other Party (and its Affiliates) the right, free of charge, to use its
name and logo on package inserts, packaging, trade packaging, samples and all
Promotional Materials used or distributed in connection with the applicable
Licensed Product in the Field in the Territory during the Term and thereafter
with respect to Promotional Materials, package inserts, packaging, labeling,
trade packaging and samples, only for the time period and solely to the extent
necessary to exhaust the existing inventory of Licensed Product (including
packaging materials for such Licensed Product) and Promotional Materials
containing such name or logo. During the Term, each Party shall submit samples
of each such package inserts, packaging, trade packaging, etc. to such other
Party for its prior approval, which approval shall not be unreasonably withheld
or delayed, at least thirty (30) days before dissemination of such materials.
Failure of the receiving Party to object within such thirty (30) day period
shall constitute approval of the submitting Party’s package inserts, packaging,
trade packaging, etc.
ARTICLE XII
NEWLY CREATED INVENTIONS AND KNOW-HOW
          12.1 Ownership of Newly Created Intellectual Property.
          (a) Subject to Section 12.1(e), each Party (and each Party’s
respective Affiliates) shall exclusively own all intellectual property
(including, without limitation,

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Know-How, Patents and Patent Applications and copyrights) discovered, invented,
authored or otherwise created in connection with the Collaboration solely by
such Party, its Affiliates, employees, agents and consultants (“Sole
Inventions”). Sole Inventions made solely by Sanofi, its Affiliates, employees,
agents and consultants are referred to herein as “Sanofi Sole Inventions”. Sole
Inventions made solely by Regeneron, its Affiliates, employees, agents and
consultants are referred to herein as “Regeneron Sole Inventions”. The Parties
agree that nothing in this Agreement, and no use by a Party of the other Party’s
Intellectual Property pursuant to this Agreement, shall vest in a Party any
right, title or interest in or to the other Party’s Intellectual Property, other
than the license rights expressly granted hereunder. Any remuneration payable
under applicable law to an inventor and costs associated with determining such
remuneration shall be treated as Other Shared Expenses.
          (b) The Parties shall jointly own all intellectual property
(including, without limitation, Know-How, Patents and Patent Applications and
copyrights) discovered, invented, authored or otherwise created under the
Collaboration during the Term that is invented or authored jointly by an
individual or individuals having an obligation to assign such intellectual
property to Sanofi or its Affiliate (or for which ownership vests in Sanofi or
its Affiliate by operation of law), on the one hand, and an individual or
individuals having an obligation to assign such intellectual property to
Regeneron or its Affiliate (or for which ownership vests in Regeneron or its
Affiliate by operation of Law), on the other hand, on the basis of each Party
(or its Affiliate) having an undivided interest in the whole (“Joint
Inventions”).
          (c) Notwithstanding the foregoing in Section 12.1(b), (i) for purposes
of determining whether a patentable invention is a Sanofi Sole Invention, a
Regeneron Sole Invention or a Joint Invention, questions of inventorship shall
be resolved in accordance with United States patent laws, (ii) for purposes of
determining whether a copyrighted work is a Sanofi Sole Invention, a Regeneron
Sole Invention or a Joint Invention, questions of copyright authorship shall be
resolved in accordance with United States copyright laws and (iii) for purposes
of determining whether Know-How (other than copyrighted work and Patent
Applications) is a Sanofi Sole Invention, a Regeneron Sole Invention or a Joint
Invention, questions of authorship or inventorship shall be resolved in
accordance with the laws of the State of New York, United States.
          (d) To the extent that any right, title or interest in or to any
intellectual property discovered, invented, authored or otherwise created under
the Collaboration during the Term vests in a Party or its Affiliate, by
operation of Law or otherwise, in a manner contrary to the agreed upon ownership
as set forth in this Agreement, such Party (or its Affiliate) shall, and hereby
does, irrevocably assign to the other Party any and all such right, title and
interest in and to such intellectual property to the other Party without the
need for any further action by any Party.
          (e) Subject to the other terms and conditions of this Agreement (other
than Section 12.1(a)), to the extent permitted under any relevant Third Party
agreement, each Party agrees that all Know-How, other than Excluded Know-How
Rights, discovered, invented, authored or otherwise created by it (or its
Affiliate) after the

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Effective Date directly in connection with the performance of the research and
clinical activities approved by the JDC, in each case, as included in the Global
Development Plans shall be Joint Inventions. Each Party agrees to execute all
necessary documentation to reflect the foregoing. As used above, the term
“Excluded Know-How Rights” shall mean any Know-How claiming or covering
composition (including any formulation) of a Licensed Product, including, for
the avoidance of doubt, any manufacturing and/or cell line related intellectual
property. For further clarity, nothing in this Section 12.1(e) shall be
construed to grant either Party any rights to Patents or Know-How of the other
Party discovered, invented, authored or otherwise created by it outside the
performance of the research activities approved by the JDC and/or the clinical
development activities approved by the JDC, in each case, as included in Global
Development Plans.
          (f) The Parties hereby agree that each Party’s use of the Joint
Inventions is governed by the terms and conditions of this Agreement shall be
governed as follows: each Party’s interest in the Joint Inventions may be
sublicensed to Third Parties, and any ownership rights therein transferred, in
whole or in part, by each Party without consent of the other Party (unless
otherwise prohibited by this Agreement); provided that (i) each of the Parties
acknowledges that it receives no rights to any Intellectual Property of the
other Party underlying or necessary for the use of any Joint Invention, except
as may be expressly set forth in Article IV, (ii) each Party agrees not to
transfer any of its ownership interest in any of the Joint Inventions without
securing the transferee’s written agreement to be bound by the terms of this
Section 12.1(e) and (iii) nothing in this Article XII shall relieve a Party or
its Affiliates of their obligations under Article XVI with respect to
confidential Party Information provided by the other Party or such other Party’s
Affiliates. Each of the Parties (or its Affiliate), as joint owner of the Joint
Inventions, agrees to cooperate with any enforcement actions brought by the
other joint owner(s) against any Third Parties, and further agrees not to grant
any licenses to any such Third Parties against which such enforcement actions
are brought during the time of such dispute, without the prior written consent
of the other joint owner(s), such consent not to be unreasonably withheld.
Neither Party hereto shall have the obligation to account to the other Party for
any revenues or profits obtained from any transfer of its interest in, or its
use, sublicense or other exploitation of, the Joint Inventions outside the scope
of the Collaboration. The provisions governing Joint Inventions set forth in
this Section 12.1(e) shall survive the expiration or termination of this
Agreement.
          12.2 Prosecution and Maintenance of Patent Rights.
          (a) Regeneron shall prepare, file, prosecute and maintain Patents and
Patent Applications (as applicable) included in the Regeneron Patent Rights in
the Territory. Regeneron shall undertake such activities using outside counsel
reasonably acceptable to Sanofi except that all provisionals, the priority
application based thereon and the corresponding PCT may be prepared and filed by
Regeneron’s in-house counsel. Regeneron shall confer with and keep Sanofi
reasonably informed regarding the status of such activities. In addition,
Regeneron shall have the following obligations with respect to the filing,
prosecution and maintenance of Regeneron Patent Rights: (i) Regeneron shall
provide to Sanofi for review and comment a substantially completed draft of any

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

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

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right to file a continuing or divisional Patent Application, abandoning any
Patent or not filing or perfecting the filing of any Patent Application in any
country), with notice of such proposed action or inaction so that the
non-Controlling Party has a reasonable opportunity to review and make comments,
and take such actions as may be appropriate in the circumstances. In the event
that the Controlling Party materially breaches the foregoing obligations and
such breach is not cured within thirty (30) days of a written notice from the
non-Controlling Party to the Controlling Party describing such breach, or in the
event that the Controlling Party fails to undertake the filing of a Patent
Application within the earlier of (i) ninety (90) days of a written request by
the non-Controlling Party to do so, and (ii) sixty (60) days prior to the
anticipated filing date, the non-Controlling Party may assume the Controlling
Party’s responsibility for filing, prosecution and maintenance of any such Joint
Patent Right, and will thereafter be deemed the Controlling Party for purposes
hereof. Notwithstanding the foregoing, the Controlling Party may withdraw from
or abandon any Patent or Patent Application relating to any Joint Patent Rights
on thirty (30) days’ prior written notice to the other Party (provided that such
notice shall be given no later than sixty (60) days prior to the next deadline
for any action that may be taken with respect to such Patent or Patent
Application with the applicable patent office), providing the non-Controlling
Party a free-of-charge option to assume the prosecution or maintenance thereof.
          (d) Each Party agrees to cooperate with the other with respect to the
preparation, filing, prosecution and maintenance of Patents and Patent
Applications pursuant to this Section 12.2, including, without limitation, the
execution of all such documents and instruments and the performance of such acts
(and causing its relevant employees to execute such documents and instruments
and to perform such acts) as may be reasonably necessary in order to permit the
other Party to continue any preparation, filing, prosecution or maintenance of
Joint Patent Rights that such Party has elected not to pursue as provided for in
Section 12.2(c). The JCC, with the approval of the JSC, will determine which of
the Sanofi Patent Rights, Regeneron Patent Rights and Joint Patent Rights for
which to seek an extension of term and the applicable Party will file for said
patent term extension.
          (e) All Out-of-Pocket Costs incurred in the filing, prosecution and
maintenance of any Sanofi Patent Rights, Regeneron Patent Rights and Joint
Patent Rights in the Territory for use in the Field, and any extensions thereof,
shall be treated as Other Shared Expenses.
          12.3 Interference, Opposition and Reissue.
          (a) Each Party will notify the other within ten (10) days of receipt
by such Party of information concerning the request for, or filing or
declaration of, any interference, opposition or reexamination relating to
Regeneron Patent Rights, Sanofi Patent Rights or Joint Patent Rights in the
Territory. The Parties will thereafter consult and cooperate fully to determine
a course of action with respect to any such proceeding. The Parties will
reasonably consult with one another in an effort to agree with respect to
decisions on whether to initiate or how to respond to such a proceeding, as
applicable, and the course of action in such proceeding, including settlement
negotiations and terms,

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provided that if such agreement cannot be reached promptly, such decisions will
be made (i) with respect to Regeneron Patent Rights, by Regeneron in
consultation with Sanofi, (ii) with respect to Sanofi Patent Rights, by Sanofi
in consultation with Regeneron and (iii) with respect to Joint Patent Rights,
jointly by the Parties.
          (b) All Out-of-Pocket Costs incurred in connection with any
interference, opposition, reissue or reexamination proceeding relating to the
Regeneron Patent Rights, Sanofi Patent Rights and/or Joint Patent Rights in the
Territory for use in the Field shall be treated as Other Shared Expenses.
ARTICLE XIII
INTELLECTUAL PROPERTY LITIGATION AND LICENSES
          13.1 Third Party Infringement Suits.
          (a) In the event that either Party or any of its Affiliates becomes
aware of an actual, potential or suspected infringement of a Sanofi Patent
Right, a Regeneron Patent Right, a Joint Patent Right, Product Trademark or any
other intellectual property right jointly owned or licensed under this
Agreement, by a Third Party’s activities in the Field in the Territory, the
Party that became aware of the infringement shall promptly notify the other
Party in writing of this claim or assertion and shall provide such other Party
with all available evidence supporting such known, potential or suspected
infringement or unauthorized use. As soon as reasonably practicable after the
receipt of such notice, the Parties shall cause the JSC to meet and consider the
appropriate course of action with respect to such infringement. The Parties
shall at all times cooperate, share all material notices and filings in a timely
manner, provide all reasonable assistance to each other and use Commercially
Reasonable Efforts to mutually agree upon an appropriate course of action,
including, as appropriate, the preparation of material court filings and any
discussions concerning prosecution and/or settlement of any such claim.
          (b) With respect to any such actual, suspected or potential
infringement by virtue of a generic or potential generic competitor’s activities
in the Field in the Territory, including but not limited to, any ANDA filing,
Paragraph IV Certification (or the equivalent for biologics) or other actual or
potential infringement by a generic or potential generic competitor anywhere in
the Territory, the Parties will consult and cooperate fully to determine a
course of action. Final decisions on whether to initiate a proceeding, and the
course of action in such proceeding, including settlement negotiations and
terms, will be made by Sanofi with active assistance from and in consultation
with Regeneron. Regeneron will provide reasonable assistance to Sanofi in
prosecuting any suit, and if required by Law, will join in the suit. Although
Sanofi has the right to select counsel of its own choice, it shall first consult
with Regeneron and consider in good faith the recommendations of Regeneron. The
amount of any recovery from any such infringement suit with respect to
activities in the Field in the Territory shall first be used to pay reasonable
costs, including attorneys’ fees, relating to such legal proceedings and then
shared equally by the Parties or according to the U.S. Profit Split and Rest of
World Profit Split if and as applicable.

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          (c) With respect to all other such actual, potential or suspected
infringement by virtue of a Third Party’s activities in the Field in the
Territory, the Parties will consult and cooperate fully in an effort to
determine a mutually agreeable course of action, provided if such agreement
cannot be reached promptly, final decisions on whether to initiate a proceeding,
and the course of action in such proceeding, including settlement negotiations
and terms, will be made (i) with respect to Regeneron Patent Rights, by
Regeneron in consultation with Sanofi, (ii) with respect to Sanofi Patent
Rights, by Sanofi in consultation with Regeneron, and (iii) with respect to
Joint Patent Rights, jointly by the Parties. Any disagreement between the
Parties concerning the enforcement of Joint Patent Rights shall be referred to
the Executive Officers for resolution. The Party initiating the litigations
shall be referred to as the “Lead Litigation Party.” The non-Lead Litigation
Party will provide reasonable assistance to the Lead Litigation Party in
prosecuting any suit, and if required by Law, will join in the suit. Although
the Lead Litigation Party has the right to select counsel of its own choice, it
shall first consult with the other Party and consider in good faith the
recommendations of the other Party. The amount of any recovery from any such
infringement suit with respect to activities in the Field in the Territory shall
first be used to pay reasonable costs, including attorneys’ fees, relating to
such legal proceedings and then shared equally by the Parties.
          (d) All Out-of-Pocket Costs incurred in connection with any litigation
under Section 13.1(b) or (c) related to activities in the Field in the Territory
shall be treated as Other Shared Expenses.
          (e) For the avoidance of doubt, neither Party will enter into any
settlement of any suit referenced in this Section 13.1 that materially affects
the other Party’s rights or obligations with respect to the applicable Licensed
Product in the Field in the Territory without the other Party’s prior written
consent. Furthermore, no Party shall enter into any Third Party intellectual
property license requiring the payment of royalties or other amounts based on
the Development, Manufacture or Commercialization of Licensed Products in the
Field in the Territory under this Agreement without the other Party’s prior
written consent.
          13.2 Patent Marking. Each Party shall comply with the patent marking
statutes in each country in which a Licensed Product in the Field is made,
offered for sale, sold or imported by such Party, its Affiliates and/or
Sublicensees.
          13.3 Third Party Infringement Claims; New Licenses.
          (a) If either Party or its Affiliates shall learn of an allegation
that the Development, Manufacture or Commercialization of any Licensed Product
in the Field in the Territory under this Agreement infringes or otherwise
violates the intellectual property rights of any Third Party in the Territory,
then such Party shall promptly notify the other Party in writing of this
allegation. As soon as reasonably practicable after the receipt of such notice
and at all times thereafter, the Parties shall meet and consider the appropriate
course of action with respect to such allegation of infringement. In any such
instance, each Party shall have the right to defend any action naming it using
its own

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counsel; however, the Parties shall at all times cooperate, share all material
notices and filings in a timely manner, provide all reasonable assistance to
each other and use Commercially Reasonable Efforts to mutually agree upon an
appropriate course of action, including, as appropriate, the preparation of
material court filings and any discussions concerning a potential defense and/or
settlement of any such claim. The rights and obligations in this Section 13.3
shall apply even if only one Party defends any claimed infringement action
commenced by a Third Party in the Territory claiming that the Development,
Manufacture and/or Commercialization of any Licensed Product in the Field under
this Agreement infringes or otherwise violates any intellectual property rights
of any Third Party.
          (b) Except as otherwise set forth in this Agreement, all Out-of-Pocket
Costs (except for the expenses of the non-controlling Party’s counsel, if only
one Party defends a claim) incurred in connection with any litigation referred
to in this Section 13.3 shall be treated as Other Shared Expenses.
          (c) **************************.
          (d) License fees, royalties and other payments under Licenses to the
extent attributable to, and based on, the discovery, Development and Manufacture
of Commercial Supply Requirements or the Commercialization of Licensed Products
in the Field in the Territory shall be treated as Other Shared Expenses.
          (e) **************************************************.
ARTICLE XIV
BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS
          14.1 Books and Records. Each Party shall, and shall cause each of its
respective Affiliates to, keep proper books of record and account in which full,
true and correct entries (in conformity with GAAP or IAS/IFRS) shall be made for
the purpose of determining the amounts payable or owed pursuant to this
Agreement. Each Party shall, and shall cause each of its respective Affiliates
to, permit auditors, as provided in Section 14.2, to visit and inspect, during
regular business hours and under the guidance of officers of the Party being
inspected, and to examine the books of record and account of such Party or such
Affiliate to the extent relating to this Agreement and discuss the affairs,
finances and accounts of such Party or such Affiliate to the extent relating to
this Agreement with, and be advised as to the same by, its and their officers
and independent accountants.
          14.2 Audits and Adjustments.
          (a) Each Party shall have the right (at its own cost), upon no less
than thirty (30) days advance written notice and at such reasonable times and
intervals and to such reasonable extent as the investigating Party shall
request, not more than once during

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any Contract Year, to have the books and records of the other Party and its
Affiliates to the extent relating to this Agreement for the preceding two
(2) years audited by an independent “Big Four” (or equivalent) accounting firm
of its choosing under reasonable appropriate confidentiality provisions, for the
sole purpose of verifying the accuracy of all financial, accounting and
numerical information and calculations provided, and payments made, under this
Agreement; provided that no period may be subjected to audit more than one
(1) time unless a material discrepancy is found in any such audit of such
period, in which case additional audits of such period may be conducted until no
material discrepancies are found.
          (b) The results of any such audit shall be delivered in writing to
each Party and shall be final and binding upon the Parties, unless disputed by a
Party within ninety (90) days. Unless otherwise mutually agreed by the Parties,
any disputes regarding the results of any such audit shall be subject to dispute
resolution in accordance with Article X. If the audited Party or its Affiliates
have underpaid or over billed an amount due under this Agreement resulting in a
cumulative discrepancy during any year of more than seven and one-half percent
(7.5%), the audited Party shall also reimburse the other Party for the costs of
such audit (with the cost of the audit to be paid by the auditing party in all
other cases). Such accountants shall not reveal to the Party seeking
verification the details of its review, except for such information as is
required to be disclosed under this Agreement, and shall be subject to the
confidentiality provisions contained in Article XVI.
          (c) If any examination or audit of the records described above
discloses an under- or over-payment of amounts due hereunder, then unless the
result of the audit is to be contested pursuant to Section 14.2(b) above, the
Party owing any money hereunder shall pay the same (plus interest thereon at the
Default Interest Rate from the date of such underpayment through the date of
payment of the amount required to be paid pursuant to this Section 14.2(c)) to
the Party entitled thereto within thirty (30) days after receipt of the written
results of such audit pursuant to this Section.
          14.3 GAAP/IAS/IFRS. Except as otherwise provided herein, all costs and
expenses and other financial determinations with respect to this Agreement shall
be determined in accordance with, at a Party’s election, GAAP or IAS/IFRS.
ARTICLE XV
REPRESENTATIONS, WARRANTIES AND COVENANTS
          15.1 Due Organization, Valid Existence and Due Authorization;
Financial Capability. Each Party hereby represents and warrants to the other
Party, as of the Effective Date, as follows: (a) it is duly organized and
validly existing under the Laws of its jurisdiction of incorporation; (b) it has
full corporate (or, in the case of Sanofi Amerique, partnership) power and
authority and has taken all corporate (or, in the case of Sanofi Amerique,
partnership) action necessary to enter into and perform this Agreement; (c) the
execution and performance by it of its obligations hereunder will not constitute
a breach of, or conflict with, its organizational documents nor any other
agreement by which it is bound or any requirement of applicable Laws or
regulations; (d) this Agreement is its legal, valid and binding obligation,
enforceable in

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accordance with the terms and conditions hereof (subject to applicable Laws of
bankruptcy and moratorium); (e) such Party is not prohibited by the terms of any
agreement to which it is a party from granting, the licenses granted to the
other under Article IV hereof; and (f) no broker, finder or investment banker is
entitled to any brokerage, finder’s or other fee in connection with this
Agreement or the transactions contemplated hereby based on arrangements made by
it or on its behalf. Each Party hereby represents and warrants to the other
Party that such Party has, and will continue to have, sufficient liquid assets
to promptly and timely pay and perform all of the payments and obligations
required by such Party or its Affiliates to be paid and performed by them
hereunder.
          15.2 Knowledge of Pending or Threatened Litigation. Each Party
represents and warrants to the other Party that, as of the Effective Date, there
is no claim, announced investigation, suit, action or proceeding pending or, to
such Party’s knowledge, threatened, against such Party before or by any
Governmental Authority or arbitrator that, individually or in the aggregate,
could reasonably be expected to (a) materially impair the ability of such Party
to perform any of its obligations under this Agreement or (b) prevent or
materially delay or alter the consummation of any or all of the transactions
contemplated hereby. During the Term, each Party shall promptly notify the other
Party in writing upon learning of any of the foregoing.
          15.3 Additional Regeneron Representations, Warranties and Covenants.
Regeneron additionally represents and warrants to Sanofi that, as of the
Effective Date:
          (a) Regeneron owns all right, title and interest in and to all
Regeneron Patent Rights in existence as of the Effective Date;
          (b) Regeneron has the right and authority to grant the rights granted
pursuant to the terms and conditions of this Agreement and Regeneron has not
granted any rights that would be inconsistent with or in conflict with or in
derogation of the rights granted herein;
          (c) there is no pending litigation that alleges that any of
Regeneron’s activities relating to the Regeneron Intellectual Property have
violated, or would violate, the intellectual property rights of any Third Party
(nor has it received any written communication threatening such litigation);
          (d) to Regeneron’s knowledge, no litigation has been otherwise
threatened which alleges that any of its activities relating to the Regeneron
Intellectual Property have violated or would violate, any intellectual property
rights of any Third Party;
          (e) the conception, development and reduction to practice of any
Regeneron Intellectual Property existing as of the Effective Date has not
constituted or involved the misappropriation of trade secrets or other rights of
any Person;
          (f) to Regeneron’s knowledge, the issued Patents included in the
Regeneron Intellectual Property existing as of the Effective Date are not
invalid or unenforceable, in whole or part;

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          (g) Regeneron has not received any written notice of any threatened
claims or litigation seeking to invalidate or otherwise challenge the Regeneron
Patent Rights or Regeneron’s rights therein, and, to Regeneron’s knowledge, none
of the Regeneron Patent Rights are subject to any pending re-examination,
opposition, interference or litigation proceedings; and
          (h) Regeneron has enforceable written agreements with all of its
employees and contractors who may participate in the conduct of the
Collaboration or receive Confidential Information hereunder assigning to
Regeneron ownership of all intellectual property rights created in the course of
their employment or provision of services, as applicable.
          15.4 Disclaimer of Warranties. EXCEPT AS OTHERWISE SPECIFICALLY
PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR
WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, CONCERNING THE SUCCESS OR
POTENTIAL SUCCESS OF THE DEVELOPMENT, COMMERCIALIZATION, MARKETING OR SALE OF
ANY LICENSED PRODUCT IN THE FIELD. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH
PARTY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES, EXPRESS,
IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
          15.5 Mutual Covenants. Each Party hereby covenants to the other Party
as of the Effective Date as follows: (a) it will not during the Term grant any
right or license to any Third Party in the Territory which would be inconsistent
with or in conflict with or in derogation of the rights granted to the other
Party under this Agreement, and will not take any action that would materially
conflict with or adversely affect its obligations to the other Party under this
Agreement; (b) neither Party will use the Patent Rights or Know-How of the other
Party outside the scope of the licenses and rights granted to it under this
Agreement; and (c) in the course of the Development or Commercialization of a
Licensed Product in the Field under this Agreement, it will not knowingly use
and will not have knowingly used an employee or consultant who is or has been
debarred by a Regulatory Authority or, to the best of such Party’s knowledge, is
or has been the subject of debarment proceedings by a Regulatory Authority.
ARTICLE XVI
CONFIDENTIALITY
          16.1 Confidential Information.
          (a) Each of Sanofi and Regeneron acknowledges (subject to the further
provisions of this Article XVI and the provisions of Article XIX) that all Party
Information provided to it (or its Affiliate) or otherwise made available to it
by the other Party or its respective Affiliates pursuant to this Agreement (or,
in the case of Sanofi, Party Information provided to it under the
Confidentiality Agreements is confidential and proprietary to such other Party.
Furthermore, each of Sanofi and Regeneron acknowledges (subject to the further
provisions of this Article XVI) that all New

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Information is confidential and proprietary to both Parties. Subject to the
further provisions of this Article XVI, each of Sanofi and Regeneron agrees to
(i) maintain such Party Information of the other Party (or its Affiliates) and
all New Information in confidence during the Term and for a period of ten
(10) years thereafter and (ii) use such Party Information of the other Party (or
its Affiliate) and New Information solely for the purpose of exercising its
rights and performing its obligations hereunder. Each of Sanofi and Regeneron
covenants that neither it nor any of its respective Affiliates shall disclose
any such Party Information of the other Party (or its Affiliate) or New
Information to any Third Party except (A) to its employees, agents, consultants
or any other Person under its authorization; provided such employees, agents,
consultants or Persons are subject in writing to substantially the same
confidentiality obligations as the Parties, (B) as approved by both Parties
hereunder or (C) as set forth elsewhere in this Agreement.
          (b) Notwithstanding anything provided above, the restrictions provided
in this Article XVI shall not apply to information that was or is (and such
information shall not be considered confidential or proprietary under this
Agreement) (i) already in the public domain as of the Effective Date or becomes
publicly known through no act, omission or fault of the receiving Party or its
Affiliate or any Person to whom the receiving Party or its Affiliate provided
such information; (ii) already in the possession of the receiving Party or its
Affiliate at the time of disclosure by the disclosing Party, other than under an
obligation of confidentiality; (iii) disclosed to the receiving Party or its
Affiliate on an unrestricted basis from a Third Party not under an obligation of
confidentiality to the other Party or any Affiliate of such other Party with
respect to such information; (iv) similar in nature to the purported Party
Information or New Information but has been independently created, as evidenced
by written or electronic documentation, without any aid, application or use of
the Party Information or New Information; (v) necessary to file, prosecute or
defend Patents and Patent Applications for which the Party has the right to
assume filing, prosecution, defense or maintenance pursuant to this Agreement;
or (vi) required by a Governmental Authority, applicable Law (including the
rules and regulations of any stock exchange or trading market on which the
disclosing Party’s (or its parent entity’s) securities are traded), or court
order to be disclosed, provided that the receiving Party uses reasonable efforts
to give the disclosing Party advance notice of such required disclosure in
sufficient time to enable the disclosing Party to seek confidential treatment
for such information or to request that the receiving Party seek confidential
treatment for such information, if applicable, and provided, further, that the
receiving Party provides all reasonable cooperation to assist the disclosing
Party to protect such information and limits the disclosure to that information
which is required by Governmental Authority, applicable Law (including the rules
or regulations of any stock exchange or trading market on which the disclosing
Party’s (or its parent entity’s) securities are traded) or court order to be
disclosed. Moreover, either Party may use Party Information and New Information
to enforce the terms of this Agreement if it gives reasonable advance notice to
the other Party to permit the other Party a sufficient opportunity to take any
measures to ensure confidential treatment of such information and the disclosing
Party shall provide reasonable cooperation to protect the confidentiality of
such information.

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          (c) Notwithstanding anything provided above or elsewhere in this
Agreement, Regeneron and its Affiliates shall have the right to use and disclose
any New Information directly related to any Licensed Product (including the
Manufacture or use thereof) to Governmental Authorities or Regulatory
Authorities as required by Law.
          (d) Notwithstanding anything provided above or elsewhere in this
Agreement, Sanofi and its Affiliates shall have the right to use and disclose
any New Information directly related to any Licensed Product (including the
Manufacture or use thereof) to Governmental Authorities or Regulatory
Authorities as required by Law.
          16.2 Injunctive Relief. The Parties hereby acknowledge and agree that
the rights of the Parties hereunder are special, unique and of extraordinary
character, and that if any Party refuses or otherwise fails to act, or to cause
its Affiliates to act, in accordance with the provisions of this Agreement, such
refusal or failure would result in irreparable injury to the other Party, the
exact amount of which would be difficult to ascertain or estimate and the
remedies at law for which would not be reasonable or adequate compensation.
Accordingly, if any Party refuses or otherwise fails to act, or to cause its
Affiliates to act, in accordance with the provisions of this Agreement, then, in
addition to any other remedy which may be available to any damaged Party at law
or in equity, such damaged Party will be entitled to seek specific performance
and injunctive relief, without posting bond or other security, and without the
necessity of proving actual or threatened damages, which remedy such damaged
party will be entitled to seek in any court of competent jurisdiction.
          16.3 Publication of New Information. During the Term, if either Sanofi
or Regeneron (the “Publishing Party”) desires to disclose any New Information in
scientific journals, publications or scientific presentations, the Publishing
Party shall provide the other Party an advance copy of any proposed publication
or summary of a proposed oral presentation relating to the New Information prior
to submission for publication or disclosure. Such other Party shall have a
reasonable opportunity to recommend any changes it reasonably believes are
necessary to prevent any specific, material adverse effect to it or the Licensed
Product as a result of the publication or disclosure (such recommendation of
changes to include a description of the specific material adverse effect) to
which the Publishing Party shall give due consideration. Disputes concerning
publication shall be resolved by the JDC (other than Legal Disputes).
          16.4 Disclosures Concerning this Agreement. The Parties will mutually
agree upon the contents of their respective press releases with respect to the
execution of this Agreement and any Ancillary Agreement which shall be issued
simultaneously by both Parties on the Effective Date. Sanofi and Regeneron agree
not to (and to ensure that their respective Affiliates do not ) issue any other
press releases or public announcements concerning this Agreement, any Ancillary
Agreement or any actions or activities contemplated hereunder or thereunder
without the prior written consent of the other Party (which shall not be
unreasonably withheld or delayed), except as required by a Governmental
Authority or applicable Law (including the rules and regulations of any stock
exchange or trading market on which a Party’s (or its parent entity’s)
securities are traded); provided that the Party intending to disclose such
information shall use reasonable efforts to provide the other Party advance
notice of such required disclosure, an opportunity to review and comment on such
proposed disclosure (which comments shall be considered in good faith by the
disclosing Party) and all reasonable

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cooperation to assist the other Party to protect such information and shall
limit the disclosure to that information which is required to be disclosed.
Notwithstanding the foregoing, without prior submission to or approval of the
other Party, either Party may issue press releases or public announcements which
incorporate information concerning this Agreement, any Ancillary Agreement or
any actions or activities contemplated hereunder or thereunder which information
was included in a press release or public disclosure which was previously
disclosed under the terms of this Agreement or which contains only non-material
factual information regarding the Collaboration. Except as required by a
Governmental Authority or applicable Law (including the rules and regulations of
any stock exchange or trading market on which a Party’s (or its parent entity’s)
securities are traded), or in connection with the enforcement of this Agreement,
neither Party (or their respective Affiliates) shall disclose to any Third
Party, under any circumstances, any financial terms of this Agreement that have
not been previously disclosed publicly pursuant to this Article XVI without the
prior written consent of the other Party, which consent shall not be
unreasonably withheld or delayed; except for disclosures to Third Parties that
are bound by obligations of confidentiality and nonuse substantially equivalent
in scope to those included herein with a term of at least five (5) years. The
Parties, through the Committees, shall establish mechanisms and procedures to
ensure that there are coordinated timely corporate communications relating to
the Licensed Products in the Field. Sanofi acknowledges that Regeneron as a
publicly traded company may be legally obligated to make timely disclosures of
material events relating to Licensed Products. The Parties acknowledge that
either or both Parties may be obligated to file a copy of this Agreement and
each Ancillary Agreement with the United States Securities and Exchange
Commission or its equivalent in the Territory. Each Party will be entitled to
make such filing but shall use reasonable efforts to obtain confidential
treatment of confidential, including trade secret, information in accordance
with applicable Law. The filing Party will provide the non-filing Party with an
advance copy of the Agreement marked to show provisions for which the filing
Party intends to seek confidential treatment and will reasonably consider the
non-filing Party’s timely comments thereon.
ARTICLE XVII
INDEMNITY
          17.1 Indemnity and Insurance.
          (a) Sanofi will defend, indemnify and hold harmless Regeneron, its
Affiliates and their respective officers, directors, employees, licensees and
agents (“Regeneron Indemnitees”) from and against all claims, demands,
liabilities, damages, penalties, fines, costs and expenses, including reasonable
attorneys’ and expert fees and costs, and costs or amounts paid to settle
(collectively, “Damages”), arising from or occurring as a result of a Third
Party’s claim, action, suit, judgment or settlement against a Regeneron
Indemnitee that is due to or based upon:
          (i) the gross negligence, recklessness, bad faith, intentional
wrongful acts or omissions or violations of Law by or of Sanofi, its Affiliates
or their respective directors, officers, employees, agents or Sublicensees,
including, without limitation, in connection with the Development, Manufacture
or Commercialization of any Licensed Product in the Field, except to the extent
that Damages arise out of, and are allocable to, the gross negligence,
recklessness, bad

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faith, intentional wrongful acts or omissions or violations of Law committed by
Regeneron or any other Regeneron Indemnitee; or
          (ii) material breach by Sanofi of the terms of, or the inaccuracy when
made of any representation or warranty made by it in, this Agreement.
          (b) Regeneron will defend, indemnify and hold harmless Sanofi, its
Affiliates and their respective officers, directors, employees, Sublicensees and
agents (“Sanofi Indemnitees”) from and against all Damages arising from or
occurring as a result of a Third Party’s claim, action, suit, judgment or
settlement against a Sanofi Indemnitee that is due to or based upon:
          (i) the gross negligence, recklessness, bad faith, intentional
wrongful acts or omissions or violations of Law by or of Regeneron, its
Affiliates or their respective directors, officers, employees, licensees or
agents including, without limitation, in connection with the Development,
Manufacture or Commercialization of any Licensed Product in the Field, except to
the extent that Damages arise out of, and are allocable to, the gross
negligence, recklessness, bad faith, intentional wrongful acts, or omissions or
violations of Law committed by Sanofi or any other Sanofi Indemnitee; or
          (ii) material breach by Regeneron of the terms of, or the inaccuracy
when made of any representation or warranty made by it in, this Agreement.
          (c) In the event of any Third Party claim alleging that the
Development, Manufacture and/or Commercialization of any Licensed Product in the
Field under this Agreement infringes a Patent Right of a Third Party for which
neither Party is entitled to indemnification hereunder, each Party shall
indemnify the other Party for fifty percent (50%) of all Damages therefrom and
during the Term such Damages shall be treated as Other Shared Expenses.
          (d) In the event of any Third Party product liability claim alleging
that the Development or Commercialization of any Licensed Product in the Field
causes damages for which neither Party is entitled to indemnification hereunder,
each Party shall indemnify the other for fifty percent (50%) of all Damages
therefrom and during the Term such Damages shall be treated as Other Shared
Expenses.
          (e) Each of Regeneron and Sanofi will use Commercially Reasonable
Efforts to procure and maintain during the Term and for a minimum period of five
(5) years thereafter and for an otherwise longer period as may be required by
applicable Law in countries where the project is conducted, product liability
insurance in an amount not less than **************** in the annual aggregate.
Such insurance shall insure against liability on the part of Regeneron and
Sanofi and any of its Affiliates, due to injury, disability or death of any
person or persons, or property damage arising from services performed under this
Agreement.

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          (f) Notwithstanding anything to the contrary in this Section 17.1,
neither Party shall be responsible to indemnify the other Party (or the
Regeneron Indemnitees or Sanofi Indemnitees, as the case may be) from Third
Party claims resulting from, and to the extent allocable to, the negligence,
recklessness, bad faith, intentional wrongful acts or omissions, or violations
of Law committed by Third Parties contracted to Manufacture any part of the
Clinical Supply Requirements or Commercial Supply Requirements pursuant to
Article VIII; provided, however, that nothing in this Section 17.1(f) limits
either Party’s indemnification obligations to the extent any Third Party claims
arise from the negligence, recklessness, bad faith, intentional wrongful acts or
omissions, or violations of Law committed directly by the Party that is
responsible for contracting with such Third Party Manufacturer(s) pursuant to
Article VIII.
          17.2 Indemnity Procedure. The Party entitled to indemnification under
this Article XVII (an “Indemnified Party”) shall notify the Party potentially
responsible for such indemnification (the “Indemnifying Party”) within five
(5) Business Days of becoming aware of any claim or claims asserted or
threatened against the Indemnified Party which could give rise to a right of
indemnification under this Agreement; provided, however, that the failure to
give such notice shall not relieve the Indemnifying Party of its indemnity
obligation hereunder except to the extent that such failure materially
prejudices its rights hereunder. For the avoidance of doubt, the indemnification
procedures in this Section 17.2 shall not apply to claims for which each Party
indemnifies the other Party for fifty percent (50%) of all Damages, under the
terms of Section 17.1(c).
          (a) If the Indemnifying Party has acknowledged in writing to the
Indemnified Party the Indemnifying Party’s responsibility for defending such
claim, the Indemnifying Party shall have the right to defend, at its sole cost
and expense, such claim by all appropriate proceedings, which proceedings shall
be prosecuted diligently by the Indemnifying Party to a final conclusion or
settled at the discretion of the Indemnifying Party; provided, however, that the
Indemnifying Party may not enter into any compromise or settlement unless
(i) such compromise or settlement includes as an unconditional term thereof, the
giving by each claimant or plaintiff to the Indemnified Party of a release from
all liability in respect of such claim; and (ii) such compromise or settlement
does not (A) include any admission of legal wrongdoing by the Indemnified Party,
(B) require any payment by the Indemnified Party that is not indemnified
hereunder or (C) result in the imposition of any equitable relief against the
Indemnified Party. If the Indemnifying Party does not elect to assume control of
the defense of a claim or if a good faith and diligent defense is not being or
ceases to be materially conducted by the Indemnifying Party, the Indemnified
Party shall have the right, at the expense of the Indemnifying Party, upon ten
(10) Business Days’ prior written notice to the Indemnifying Party of its intent
to do so, to undertake the defense of such claim for the account of the
Indemnifying Party (with counsel reasonably selected by the Indemnified Party
and approved by the Indemnifying Party, such approval not unreasonably withheld
or delayed); provided that the Indemnified Party shall keep the Indemnifying
Party apprised of all material developments with respect to such claim and
promptly provide the Indemnifying Party with copies of all correspondence and
documents exchanged by the Indemnified Party and the opposing party(ies) to such

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litigation. The Indemnified Party may not compromise or settle such litigation
without the prior written consent of the Indemnifying Party, such consent not to
be unreasonably withheld or delayed.
          (b) The Indemnified Party may participate in, but not control, any
defense or settlement of any claim controlled by the Indemnifying Party pursuant
to this Section 17.2 and shall bear its own costs and expenses with respect to
such participation; provided, however, that the Indemnifying Party shall bear
such costs and expenses if counsel for the Indemnifying Party shall have
reasonably determined that such counsel may not properly represent both the
Indemnifying Party and the Indemnified Party.
          (c) The amount of any Damages for which indemnification is provided
under this Article XVII will be reduced by the insurance proceeds received, and
any other amount recovered if any, by the Indemnified Party in respect of any
such Damages.
          (d) If an Indemnified Party receives an indemnification payment
pursuant to this Article XVII and subsequently receives insurance proceeds from
its insurer with respect to the Damages in respect of which such indemnification
payment(s) was made, the Indemnified Party will promptly pay to the Indemnifying
Party an amount equal to the difference (if any) between (i) the sum of such
insurance proceeds or other amounts received, and the indemnification payment(s)
received from the Indemnifying Party pursuant to this Article XVII and (ii) the
amount necessary to fully and completely indemnify and hold harmless the
Indemnified Party from and against such Damages. However, in no event will such
refund ever exceed the Indemnifying Party’s indemnification payment(s) to the
Indemnified Party under this Article XVII.
ARTICLE XVIII
FORCE MAJEURE
     Neither Party will be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached this Agreement for failure or delay
in fulfilling or performing any term of this Agreement when such failure or
delay is caused by or results from causes beyond the reasonable control of the
affected Party including, without limitation, embargoes, acts of terrorism, acts
of war (whether war be declared or not), insurrections, strikes, riots, civil
commotions or acts of God (“Force Majeure”). Such excuse from liability and
responsibility shall be effective only to the extent and duration of the
event(s) causing the failure or delay in performance and provided that the
affected Party has not caused such event(s) to occur. The affected Party will
notify the other Party of such Force Majeure circumstances as soon as reasonably
practical and will make every reasonable effort to mitigate the effects of such
Force Majeure circumstances.
ARTICLE XIX
TERM AND TERMINATION
          19.1 Term/Expiration of Term.

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          (a) The “Term” of this Agreement shall commence on the Effective Date
and, unless this Agreement is earlier terminated in its entirety in accordance
with this Article XIX, shall expire upon the later to occur of (i) the
expiration of the Discovery Program, and (ii) such time as neither Party, nor
either Party’s Affiliates or Sublicensees, is Developing or Commercializing any
Licensed Product in the Field in the Territory under this Agreement and such
cessation of Development and Commercialization activities is acknowledged by
both Parties in writing to be permanent.
          (b) Upon expiration of the Term pursuant to Section 19.1(a) above,
except as set forth in this Agreement, all licenses and rights with respect to
Licensed Products shall automatically terminate and revert to the granting
Party.
          19.2 Termination Without Cause.
          (a) By Sanofi. (i) Sanofi may terminate this Agreement in its
entirety, but only after the expiration or earlier termination of the Discovery
Program in accordance with the terms of the Discovery Agreement, or may
terminate this Agreement in the entire Territory for a particular Licensed
Product or particular Licensed Products in the Field, in any such case on twelve
(12) months’ prior written notice to Regeneron. Except as otherwise provided
below in this Section 19.2(a), in the event of such termination by Sanofi of
this Agreement in its entirety or with respect to one or more Licensed
Product(s) pursuant to this Section 19.2, this Agreement (including, without
limitation, all payment obligations hereunder) shall continue in full force and
effect through the notice period set forth above (the “Sanofi Termination Notice
Period”) and the terms of Schedule 4 (including the grant of rights and licenses
set forth in paragraph 2 thereof) shall automatically apply. Except as set forth
in this Section 19.2(a) or Schedule 4, during the Sanofi Termination Notice
Period, the Parties shall continue to Develop, Manufacture and Commercialize
Licensed Products (including the Opt-Out Products(s)) in the Field in accordance
with Plans. During the Sanofi Termination Notice Period, to the extent set forth
or requested in one or more written notices from Regeneron to Sanofi hereunder
and in any event upon the expiration of the Sanofi Termination Notice Period,
whether or not any such notice is given by Regeneron, (i) the licenses and
rights granted by Regeneron to Sanofi hereunder with respect to the Opt-Out
Product(s) shall automatically terminate as of a date specified in such
notice(s) (and in any event not later than the expiration of the Sanofi
Termination Notice Period), (ii) the licenses and rights granted by Sanofi to
Regeneron hereunder with respect to the Opt-Out Product(s) shall terminate, and
(iii) Sanofi will promptly take the actions required by Schedule 4 and Regeneron
will reasonably cooperate with Sanofi (for avoidance of doubt, such cooperation
shall not require Regeneron to pay any amounts or incur any liabilities or
obligations not otherwise required hereunder to be paid or incurred by
Regeneron) to facilitate Regeneron’s (or its nominee’s) expeditious assumption
during the Sanofi Termination Notice Period and thereafter, with as little
disruption as reasonably possible, of the continued Development, Manufacture and
Commercialization of the Opt-Out Product(s) in the Field in the Territory. In
addition, during the Sanofi Termination Notice Period, neither Party will,
without the prior written consent of the other Party’s representatives on the
applicable Committee, propose or implement any amendment or

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change to any Plan. Notwithstanding the foregoing, the Committee(s) will have an
obligation under this Agreement and the Collaboration Purpose to propose and
adopt in a timely manner an interim Plan for any Plan that expires during the
Sanofi Termination Notice Period. The most recent approved Plan(s) shall be
extended pending approval of the new interim Plan(s).
          (ii) In addition to Sanofi’s termination rights set forth in Section
19.2(a)(i), from and after the twelfth (12th) anniversary of the First
Commercial Sale of a Licensed Product in a country, Sanofi may, upon twenty-four
(24) months’ prior written notice to Regeneron, terminate this Agreement with
respect to such Licensed Product in such country. If Sanofi exercises such
right, the provisions of Section 19.2(a)(i) (except that the Sanofi Termination
Notice Period referred to therein shall be twenty-four (24) months rather than
twelve (12) months), and Sections 19.7(a) and 19.8 shall apply with respect to
such Terminated Licensed Product in such country.
          (b) By Regeneron. Regeneron may terminate this Agreement in its
entirety, but only after the expiration or earlier termination of the Discovery
Program in accordance with its terms, or may terminate this Agreement in the
entire Territory for a particular Licensed Product or particular Licensed
Products in the Field, in any such case, on twelve (12) months’ prior written
notice to Sanofi. Except as otherwise provided below in this Section 19.2(b), in
the event of such termination by Regeneron of this Agreement in its entirety or
with respect to one or more Licensed Product(s) pursuant to this Section
19.2(b), this Agreement (including, without limitation, all payment obligations
hereunder) shall continue in full force and effect through the notice period set
forth above (the “Regeneron Termination Notice Period”) and the terms of
Schedule 5 (including the grant of rights and licenses set forth in paragraph 2
thereof) shall automatically apply. Except as set forth in this Section 19.2(b)
or Schedule 5, during the Regeneron Termination Notice Period, the Parties shall
continue to Develop, Manufacture and Commercialize Licensed Products (including
the Opt-Out Products(s)) in the Field in accordance with Plans. During the
Regeneron Termination Notice Period, to the extent set forth or requested in one
or more written notices from Sanofi to Regeneron hereunder and in any event upon
the expiration of the Regeneron Termination Notice Period, whether or not any
such notice is given by Sanofi, (i) the licenses and rights granted by Sanofi to
Regeneron hereunder with respect to the Opt-Out Product(s) shall automatically
terminate as of a date specified in such notice(s) (and in any event not later
than the expiration of the Regeneron Termination Notice Period), (ii) the
licenses and rights granted by Regeneron to Sanofi hereunder with respect to the
Opt-Out Products(s) shall terminate, and (iii) Regeneron will promptly take the
actions required by Schedule 5 and Sanofi will reasonably cooperate with
Regeneron (for avoidance of doubt, such cooperation shall not require Sanofi to
pay any amounts or incur any liabilities or obligations not otherwise required
hereunder to be paid or incurred by Sanofi) to facilitate Sanofi’s (or its
nominee’s) expeditious assumption during the Regeneron Termination Notice Period
and thereafter, with as little disruption as reasonably possible, of the
continued Development, Manufacture and Commercialization of the Opt-Out
Product(s) in the Field in the Territory. In addition, during the Regeneron
Termination

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Notice Period, neither Party will, without the prior written consent of the
other Party’s representatives on the applicable Committee, propose or implement
any amendment or change to any Plan. Notwithstanding the foregoing, the
Committee(s) will have an obligation under this Agreement and the Collaboration
Purpose to propose and adopt in a timely manner an interim Plan for any Plan
that expires during the Regeneron Termination Notice Period. The most recent
approved Plan(s) shall be extended pending approval of the new interim Plan(s).
          19.3 Termination For Material Breach. Upon and subject to the terms
and conditions of this Section 19.3, this Agreement shall be terminable by a
Party in its entirety or for a particular Licensed Product or particular
Licensed Products in the Field in the entire Territory, upon written notice to
the other Party, if such other Party commits a material breach of its
obligations under this Agreement with respect to such Licensed Product(s) as to
which such notice of termination is given (or all Licensed Products if such
notice of termination is with respect to this Agreement is in its entirety).
Such notice of termination shall set forth in reasonable detail the facts
underlying or constituting the alleged breach (and specifically referencing the
provisions of this Agreement alleged to have been breached), and the termination
which is the subject of such notice shall be effective ninety (90) days after
the date such notice is given unless the breaching Party shall have cured such
breach within such ninety (90) day period (or, if such material breach, by its
nature, is a curable breach but such breach is not curable within such ninety
(90) day period, such longer period not to exceed one hundred eighty (180) days
so long as the breaching party is using Commercially Reasonable Efforts to cure
such breach, in which event if such breach has not been cured, such termination
shall be effective on the earlier of the expiration of such one hundred eighty
(180) day period or such time as the breaching party ceases to use Commercially
Reasonable Efforts to cure such breach). Notwithstanding the foregoing, in the
case of breach of a payment obligation hereunder, the ninety (90) day period
referred to in the immediately preceding sentence shall instead be thirty
(30) days (and the immediately preceding parenthetical clause in the immediately
preceding sentence shall not apply). For purposes of this Section 19.3, the term
“material breach” shall mean an intentional, continuing (and uncured within the
time period described above) material breach by a Party, as determined by a
court of competent jurisdiction.
          19.4 Termination for Insolvency. Either Party shall have the right to
terminate this Agreement in its entirety, by and effective immediately, upon
written notice to the other Party, if, at any time, (a) the other Party shall
file in any court or agency pursuant to any statute or regulation of any state
or country, a petition in bankruptcy or insolvency or for reorganization or for
an arrangement or for the appointment of a receiver or trustee of the Party or
of its assets, (b) if the other Party shall be served with an involuntary
petition against it, filed in any insolvency proceeding, and such petition shall
not be dismissed or stayed within ninety (90) days after the filing thereof or
(c) if the other Party shall make a general assignment for the benefit of
creditors. In the event that this Agreement is terminated or rejected by a Party
or its receiver or trustee under applicable bankruptcy Laws due to such Party’s
bankruptcy, then all rights and licenses granted under or pursuant to this
Agreement by such Party to the other Party are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and any similar
Laws in any other country in the Territory, licenses of rights to “intellectual
property” as defined under Section 101(35A) of the U.S. Bankruptcy Code. The
Parties agree

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that all intellectual property rights licensed hereunder, including, without
limitation, any patents or patent applications in any country of a party covered
by the license grants under this Agreement, are part of the “intellectual
property” as defined under Section 101(52) of the Bankruptcy Code subject to the
protections afforded the non-terminating Party under Section 365(n) of the
Bankruptcy Code, and any similar law or regulation in any other country.
          19.5 Termination for Breach of Standstill or Lock-Up. Regeneron shall
have the unilateral right to terminate this Agreement in its entirety, effective
immediately upon written notice to Sanofi, if Sanofi or any of its Affiliates
shall have breached their obligations under any of Sections 3, 4 or 5 of the
Investor Agreement (to the extent such sections of the Investor Agreement is
then in effect). Furthermore, Regeneron shall have the unilateral right to
terminate this Agreement in its entirety, effective immediately upon written
notice to Sanofi, if Sanofi or any of its Affiliates shall have (a) breached
their obligations under Section 20.16 of the Aventis Collaboration Agreement, to
the extent that such Section 20.16 remains in effect after the Effective Date,
or (b) breached its obligations under Section 5.3 of the Aventis Stock Purchase
Agreement, to the extent that such Section 5.3 remains in effect after the
Effective Date. Any such breach of the Investor Agreement, the Aventis Stock
Purchase Agreement or the Aventis Collaboration Agreement, as the case may be,
shall be treated as a breach of this Agreement. Notwithstanding the foregoing
and for the avoidance of doubt, Regeneron shall not have the right to terminate
this Agreement as a result of (i) a de minimus breach of Section 3.1(a) of the
Investor Agreement (to the extent such Section 3.1(a) is in effect after the
Effective Date) or of Section 20.16(a) of the Aventis Collaboration Agreement
(to the extent such Section 20.16(a) remains in effect after the Effective Date)
or (ii) an inadvertent breach of Section 3.1(g) of the Investor Agreement (to
the extent such Section 3.1(g) is in effect after the Effective Date) or an
inadvertent breach of Section 20.16(g) of the Aventis Collaboration Agreement
(to the extent such Section 20.16(g) remains in effect after the Effective
Date), arising from informal discussions covering general corporate or other
business matters the purpose of which is not intended to effectuate or lead to
any of the actions referred to in paragraphs (a) through (e) of such
Section 20.16 or of paragraphs (a) through (e) of Section 3.1 of the Investor
Agreement, as applicable.
          19.6 Termination of Discovery Agreement.
          (a) By Regeneron. Regeneron may terminate this Agreement in its
entirety, effective upon written notice to Sanofi, if the Discovery Agreement
has been terminated by Regeneron pursuant to Section 12.2, 12.3 or 12.5 thereof.
          (b) By Sanofi. Sanofi may terminate this Agreement in its entirety
effective upon written notice to Regeneron, if the Discovery Agreement has been
terminated by Sanofi pursuant to Section 12.2 or 12.3 thereof.
          (c) Automatic. This Agreement shall automatically terminate in its
entirety if, at the time the Discovery Agreement terminates for any reason
pursuant to Article 12 thereof, Sanofi has not exercised its Opt-In Right
pursuant to Section 5.3 of the Discovery Agreement with respect to any Product
Candidate.
          19.7 Effect of Termination.

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          (a) Except as provided in Section 19.2(b), and in Section 19.7(b)
below, upon termination of this Agreement with respect to all Licensed Products
in the Field, or for a particular Licensed Product or particular Licensed
Products in the Field in the Territory or, if applicable pursuant to
Section 19.2(a)(ii), in one or more countries, the provisions of Schedule 4
shall apply (including during any applicable Termination Notice Period) with
respect to the Terminated Licensed Product(s), and except to the extent required
by Sanofi to fulfill its obligations pursuant to Schedule 4, (i) all licenses
and rights granted by Regeneron to Sanofi hereunder with respect to the
Terminated Licensed Product(s) shall automatically terminate, and revert to
Regeneron, (ii) all licenses and rights granted by Sanofi to Regeneron hereunder
with respect to the Terminated Licensed Product(s) shall automatically terminate
and (iii) the license from Sanofi and its Affiliates to Regeneron referred to in
Schedule 4 shall automatically come into full force and effect with respect to
the Terminated Licensed Product(s). If Regeneron terminates this Agreement
pursuant to Section 19.3, 19.4 or 19.5, or pursuant to Section 19.6(a) then
Sanofi shall pay to Regeneron, in addition to any other amount payable by Sanofi
to Regeneron under this Agreement, under Law, or pursuant to any contractual
remedies available to Regeneron, an amount equal to one hundred percent (100%)
of the Development Costs incurred by Regeneron under the Global Development Plan
during the period commencing on the effective date of such termination of this
Agreement pursuant to any of such Sections and ending on the twelve (12) month
anniversary of such date.
          (b) Upon termination of this Agreement by Regeneron pursuant to
Section 19.2(b) or by Sanofi pursuant to Section 19.3 or 19.4, in its entirety,
or for a particular Licensed Product or particular Licensed Products in the
Field, the provisions of Schedule 5 shall apply (including during any applicable
Termination Notice Period) with respect to the Terminated Licensed Product(s)
and, except to the extent required by Regeneron to fulfill its obligations
pursuant to Schedule 5, (i) all licenses and rights granted by Sanofi to
Regeneron hereunder with respect to the Terminated Licensed Product(s) shall
automatically terminate, and revert to Sanofi, (ii) all licenses and rights
granted by Regeneron to Sanofi hereunder with respect to the Terminated Licensed
Product(s) shall automatically terminate and (iii) the license from Regeneron
referred to in Schedule 5 shall come into full force and effect with respect to
the Terminated Licensed Product(s)
          19.8 Survival of Obligations. Except as otherwise provided in this
Article XIX, or Schedule 4 or Schedule 5, upon expiration, or upon termination
of this Agreement with respect to all Licensed Products in the Field, or for a
particular Licensed Product or particular Licensed Products in the Field in the
Territory or, if applicable pursuant to Section 19.2(a)(ii), in one or more
countries, the rights and obligations of the Parties hereunder with respect to
the Terminated Licensed Product(s), in the applicable country or countries if
such termination is pursuant to Section 19.2(a)(ii), shall terminate, and this
Agreement shall cease to be of further force or effect to the extent of such
termination, provided that notwithstanding any expiration or termination of this
Agreement:

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          (a) neither Sanofi nor Regeneron shall be relieved of any obligations
(including payment obligations) of such Party arising prior to such expiration
or termination, including, without limitation, the payment of any non-cancelable
costs and expenses incurred as part of a Plan (even if such costs and expenses
arise following termination or expiration, as the case may be), except that
Regeneron’s obligations with respect to the Global Development Balance payments
provided for in Schedule 2 shall automatically terminate and the Global
Development Balance shall equal zero;
          (b) subject to the provisions of this Article XIX, including
Schedule 4 and Schedule 5 to the extent applicable, the obligations of the
Parties with respect to the protection and nondisclosure of Party Information
and New Information in accordance with Article XVI, as well as other provisions
(including, without limitation, Sections 7.4, 9.8, 9.9, 9.12, 10.3 and 10.4, the
second sentence of Section 12.1(e) and Articles XII (with respect to Joint
Inventions), XVI, XVII, XIX and XX) which by their nature are intended to
survive any such expiration or termination, shall survive and continue to be
enforceable; and
          (c) such expiration or termination and this Article XIX shall be
without prejudice to any rights or remedies a party may have for breach of this
Agreement.
ARTICLE XX
MISCELLANEOUS
          20.1 Governing Law; Submission to Jurisdiction. This Agreement shall
be governed by and construed in accordance with the Laws of the State of New
York, without regard to the conflict of laws principles thereof that would
require the application of the Law of any other jurisdiction. Except as set
forth in Article X, the Parties irrevocably and unconditionally submit to the
exclusive jurisdiction of the United States District Court for the Southern
District of New York solely and specifically for the purposes of any action or
proceeding arising out of or in connection with this Agreement.
          20.2 Waiver. Waiver by a Party of a breach hereunder by the other
Party shall not be construed as a waiver of any subsequent breach of the same or
any other provision. No delay or omission by a Party in exercising or availing
itself of any right, power or privilege hereunder shall preclude the later
exercise of any such right, power or privilege by such Party. No waiver shall be
effective unless made in writing with specific reference to the relevant
provision(s) of this Agreement and signed by a duly authorized representative of
the Party granting the waiver.
          20.3 Notices. All notices, instructions and other communications
required or permitted hereunder or in connection herewith shall be in writing,
shall be sent to the address of the relevant Party set forth on Schedule 6
attached hereto and shall be (a) delivered personally, (b) sent via a reputable

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nationwide overnight courier service, or (c) sent by facsimile transmission,
with a confirmation copy to be sent by registered or certified mail, return
receipt requested, postage prepaid. Any such notice, instruction or
communication shall be deemed to have been delivered upon receipt if delivered
by hand, one (2) Business Days after it is sent via a reputable nationwide
overnight courier service or when transmitted with electronic confirmation of
receipt, if transmitted by facsimile (if such transmission is made during
regular business hours of the recipient on a Business Day; or otherwise, on the
next Business Day following such transmission). Either Party may change its
address by giving notice to the other Party in the manner provided above.
          20.4 Entire Agreement. This Agreement, together with the Discovery
Agreement and, solely to the extent referred to herein, the Ancillary Agreements
contain the complete understanding of the Parties with respect to the subject
matter hereof and thereof and supersedes all prior understandings and writings
relating to the subject matter hereof and thereof, provided that the last
sentence of Section 1.41 of the Discovery Agreement shall apply with respect to
any conflict or inconsistency between this Agreement and the Discovery
Agreement.
          20.5 Amendments. No provision in this Agreement shall be supplemented,
deleted or amended except in a writing executed by an authorized representative
of each of Sanofi and Regeneron.
          20.6 Interpretation. The captions to the several Articles and Sections
of this Agreement are included only for convenience of reference and shall not
in any way affect the construction of, or be taken into consideration in
interpreting, this Agreement. In this Agreement: (a) the word “including” shall
be deemed to be followed by the phrase “without limitation” or like expression;
(b) references to the singular shall include the plural and vice versa;
(c) references to masculine, feminine and neuter pronouns and expressions shall
be interchangeable; and (d) the words “herein” or “hereunder” relate to this
Agreement.
          20.7 Severability. If, under applicable Laws, any provision hereof is
invalid or unenforceable, or otherwise directly or indirectly affects the
validity of any other material provision(s) of this Agreement in any
jurisdiction (“Modified Clause”), then, it is mutually agreed that this
Agreement shall endure and that the Modified Clause shall be enforced in such
jurisdiction to the maximum extent permitted under applicable Laws in such
jurisdiction; provided that the Parties shall consult and use all reasonable
efforts to agree upon, and hereby consent to, any valid and enforceable
modification of this Agreement as may be necessary to avoid any unjust
enrichment of either Party and to match the intent of this Agreement as closely
as possible, including the economic benefits and rights contemplated herein.
          20.8 Registration and Filing of the Agreement. To the extent that a
Party concludes in good faith that it is or may be required to file or register
this Agreement or a notification thereof with any Governmental Authority in
accordance with applicable Laws, such Party may do so subject to the provisions
of Section 16.4. The other Party shall promptly cooperate in such filing or
notification and shall promptly execute all documents reasonably required in
connection therewith. The Parties shall promptly inform each other as to the
activities or inquiries of any such Governmental Authority relating to this
Agreement, and shall promptly cooperate to respond to any request for further
information therefrom.
          20.9 Assignment. Except as otherwise expressly provided herein,
neither this Agreement nor any of the rights or obligations hereunder may be
assigned by either Sanofi or Regeneron without (a) the prior written consent of
Regeneron in the case of any assignment by

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Sanofi or (b) the prior written consent of Sanofi in the case of an assignment
by Regeneron, except in each case (i) to an Affiliate of the assigning Party
that has and will continue to have the resources and financial wherewithal to
fully meet its obligations under this Agreement, provided that the assigning
Party shall remain primarily liable hereunder notwithstanding any such
assignment, or (ii) to any other party who acquires all or substantially all of
the business of the assigning Party by merger, sale of assets or otherwise, so
long as such Affiliate or other party agrees in writing to be bound by the terms
of this Agreement. The assigning Party shall remain primarily liable hereunder
notwithstanding any such assignment. Any attempted assignment in violation
hereof shall be void.
          20.10 Successors and Assigns. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their respective successors and
permitted assigns, and shall also inure to the benefit of the Regeneron
Indemnitees and Sanofi Indemnitees to the extent provided in the last sentence
of Section 20.13.
          20.11 Affiliates. Each Party may, and to the extent it is in the best
interests of the Licensed Products in the Field in the Territory shall, perform
its obligations hereunder through one or more of its Affiliates. Each Party
absolutely, unconditionally and irrevocably guarantees to the other Party the
prompt and timely performance when due and at all times thereafter of the
responsibilities, liabilities, covenants, warranties, agreements and
undertakings of its Affiliates pursuant to this Agreement. Sanofi Amerique
guarantees to Regeneron the prompt and timely payment of amounts payable by
Sanofi to Regeneron hereunder once those amounts have become legally due and
payable. Without limiting the foregoing, no Party shall cause or permit any of
its Affiliates to commit any act (including any act or omission) which such
Party is prohibited hereunder from committing directly. If an Affiliate of a
Party will engage in the Development, Manufacture or Commercialization of a
Licensed Product under this Agreement, then such Party shall enter into a
separate agreement with such Affiliate pursuant to which the obligations of such
Party hereunder shall be binding on such Affiliate and which shall provide that
the other Party is a third-party beneficiary of such agreement entitled to
enforce such agreement and this Agreement against such Affiliate. Each Party
represents and warrants to the other Party that it has licensed or will license
from its Affiliates the Patents and Know-How owned by its Affiliates that are to
be licensed (or sublicensed) to the other Party under this Agreement.
          20.12 Counterparts. This Agreement may be executed in counterparts,
each of which shall be deemed an original but which together shall constitute
one and the same instrument.
          20.13 Third-Party Beneficiaries. None of the provisions of this
Agreement shall be for the benefit of or enforceable by any Third Party,
including any creditor of any Party hereto. No Third Party shall obtain any
right under any provision of this Agreement or shall by reason of any such
provision make any claim in respect of any debt, liability or obligation (or
otherwise) against any Party hereto. Notwithstanding the foregoing, Article XVII
is intended to benefit, in addition to the Parties, the other Regeneron
Indemnitees and Sanofi Indemnitees as if they were parties hereto, but this
Agreement is enforceable only by the Parties.

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          20.14 Relationship of the Parties. Each Party shall bear its own costs
incurred in the performance of its obligations hereunder without charge or
expense to the other Party except as provided for in this Agreement. Neither
Sanofi nor Regeneron shall have any responsibility for the hiring, termination
or compensation of the other Party’s employees or for any employee compensation
or benefits of the other Party’s employees. No employee or representative of a
Party shall have any authority to bind or obligate the other Party to this
Agreement for any sum or in any manner whatsoever, or to create or impose any
contractual or other liability on the other Party without said Party’s approval.
For all purposes, and notwithstanding any other provision of this Agreement to
the contrary, Regeneron’s legal relationship under this Agreement to Sanofi, and
Sanofi’s legal relationship under this Agreement to Regeneron, shall be that of
an independent contractor. Nothing in this Agreement shall be construed to
establish a relationship of partners or joint ventures between the Parties or
any of their respective Affiliates.
          20.15 Limitation of Damages. IN NO EVENT SHALL REGENERON OR SANOFI BE
LIABLE FOR SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES
(INCLUDING, WITHOUT LIMITATION, LOSS OF PROFITS) SUFFERED BY THE OTHER PARTY,
REGARDLESS OF THE THEORY OF LIABILITY (INCLUDING CONTRACT, TORT, NEGLIGENCE,
STRICT LIABILITY OR OTHERWISE) AND REGARDLESS OF ANY PRIOR NOTICE OF SUCH
DAMAGES. HOWEVER, NOTHING IN THIS SECTION 20.15 IS INTENDED TO LIMIT OR RESTRICT
THE INDEMNIFICATION RIGHTS AND OBLIGATIONS OF EITHER PARTY HEREUNDER WITH
RESPECT TO THIRD-PARTY CLAIMS .
          20.16 Non-Solicitation. During the Term and for a period of two
(2) years thereafter, neither Party shall solicit or otherwise induce or attempt
to induce any employee of the other Party directly involved in the Development,
Manufacture or Commercialization of any Licensed Product to leave the employment
of the other Party and accept employment with the first Party. Notwithstanding
the foregoing, this prohibition on solicitation does not apply to actions taken
by a Party solely as a result of an employee’s affirmative response to a general
recruitment effort carried through a public solicitation or general
solicitation.
          20.17 No Strict Construction. This Agreement has been prepared jointly
and will not be construed against either Party.
[Remainder of page intentionally left blank; signature page follows]

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

            AVENTIS PHARMACEUTICALS INC.
      By:   /s/ Karen Linehan         Name:   Karen Linehan        Title:  
Authorized Signatory     

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

            SANOFI-AVENTIS AMERIQUE DU NORD
(solely for purposes of Section 15.1, 15.2 and
20.11).
      By:   /s/ Jean-Luc Renard         Name:   Jean-Luc Renard        Title:  
Authorized Signatory     

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

            REGENERON PHARMACEUTICALS, INC.
      By:   /s/ Leonard Schleifer         Name:   Leonard Schleifer       
Title:   President & CEO     

 

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EXHIBIT A
Royalties For Opt-Out Products

      Stage of Development at Opt-Out   Royalties on Net Sales
**************
  ********
*************
  ********

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EXHIBIT B
Summary Outline of Initial Development Plan For REGN88 (IL-6RmAb)
**********************

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SCHEDULE 1
Manufacturing Cost
********************

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SCHEDULE 2
Quarterly True-Up
At the end of each Quarter, the Parties will calculate the net payment one Party
shall be required to make to the other Party (the “Quarterly True-Up”) equal to
(a) the U.S. Profit Split for such Quarter payable to Regeneron (as set forth in
Part I), plus (b) the Rest of World Profit Split for such Quarter payable to
Regeneron (as set forth in Part II), minus (c) the Development Compensation
Payment for such Quarter payable to Sanofi (as set forth in Part III), plus or
minus (d) the Regeneron Reimbursement Amount for such Quarter payable to either
Regeneron or Sanofi (as set forth in Part IV).
In the event that the Quarterly True-Up is an amount greater than zero, such
amount shall be payable by Sanofi to Regeneron in accordance with the terms set
forth in Article 9. In the event that the Quarterly True-Up is an amount less
than zero, the absolute value of such amount shall be payable by Regeneron to
Sanofi in accordance with the terms set forth in Article 9. An example of the
Quarterly True-Up is shown in Part V.
I. U.S. PROFIT SPLIT
The “U.S. Profit Split” shall mean fifty percent (50%) of U.S. Profits in a
Quarter. “U.S. Profits” in a Quarter shall mean aggregate Net Sales of all
Licensed Products in the U.S. in the Quarter less the sum of (a) aggregate COGS
in the U.S. in the Quarter, (b) aggregate Shared Commercial Expenses incurred by
both Parties and allocable to the U.S. in the Quarter, and (c) aggregate Other
Shared Expenses incurred by both Parties and allocable to, the U.S. in the
Quarter.
An example of a calculation of the U.S. Profit Split in a Quarter would be:
**********

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II. REST OF WORLD PROFIT SPLIT
The Parties intend to share profits from Net Sales of Licensed Products in the
Rest of World (or ROW) in each Contract Year (the “Rest of World Profit Split,”
defined below) based on the aggregate amount of such Net Sales in accordance
with the Target ROW Profit Split (defined below). Since the full calculation
cannot be done until aggregate Net Sales for the full Contract Year are known,
each Quarter, the Parties will calculate an estimated profit split for the
Quarter based on Net Sales for the Quarter in ROW and the Applicable ROW
Percentages (defined below). Following the end of each Contract Year, the
Parties will true-up the quarterly estimates of the Rest of World Profit Split
to the Target ROW Profit Split through the ROW Profit Split Annual True-Up
calculation (defined below).
The “Target ROW Profit Split” for any Contract Year shall mean a profit split
whereby ROW Profits from ROW Net Sales of all Licensed Products up to ******* in
the Contract Year are split 65% Sanofi/35% Regeneron, and ROW Profits from ROW
Net Sales of all Licensed Products from ******* up to $750 million in the
Contract Year are split 60% Sanofi/40% Regeneron, and ROW Profits from ROW Net
Sales of all Licensed Products greater than $750 million in the Contract Year
are split 55% Sanofi/45% Regeneron, with all profit splits calculated using the
assumption that the ratio of ROW Profits to ROW Net Sales is the same on each
dollar of ROW Net Sales in the Contract Year.
The “Rest of World Profit Split” (or “ROW Profit Split”) for a Quarter shall
mean *********
The “Applicable ROW Percentages” for the Quarter for each of Sanofi and
Regeneron shall mean the percentages to be used to calculate each Party’s Rest
of World Profit Split for the Quarter, as illustrated in the example below. At
the end of each Contract Year, as part of the calculation of the fourth Quarter
Rest of World Profit Split, a “ROW Profit Split Annual True-Up” shall also be
calculated to make each Party’s Rest of World Profit Split for the Contract Year
equal to the Target ROW Profit Split. Calculation of the Applicable ROW
Percentages and Rest of World Profit Splits for a Quarter and ROW Profit Split
Annual True-Up for a Contract Year are illustrated in the example below.
**************
Notwithstanding the method of calculation shown above, in any Quarter (or for
any full Contract Year) in which the ROW Profits are negative, the Applicable
ROW Percentages for such Quarter

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(or for such Contract Year after calculation of the ROW Profit Split Annual
True-Up) shall be fifty-five percent (55%) for Sanofi and forty-five percent
(45%) for Regeneron.
An example of a calculation of the Rest of World Profit Split in a Quarter would
be:

                  Aggregate   Sanofi   Regeneron  
Net Sales in the ROW
  *******   ******   *****
 
           
COGS
  *******   ******   ******
 
           
Shared Commercial Expenses
  *******   ******   ****
 
           
Other Shared Expenses
  *******   ******   *****
 
                     
ROW Profits
  ******   ******   *****
 
           
Applicable ROW Percentages
      ***   ***
 
           
ROW Profit Split
      ***   ***

III. DEVELOPMENT COMPENSATION PAYMENT
The “Regeneron Profit Split” in a Quarter shall mean the sum of (a) the U.S.
Profit Split for such Quarter payable to Regeneron plus (b) the Rest of World
Profit Split for such Quarter payable to Regeneron.
The “Development Balance” as of the end of a Quarter shall mean **********
If both the Development Balance as of the end of a Quarter is greater than zero
and the Regeneron Profit Split for the Quarter is greater than zero, the
“Development Compensation Payment” for such Quarter shall equal the lower of (a)
************* and (b) the Development Balance. Otherwise, the Development
Compensation Payment for the Quarter shall equal zero.

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An example of a calculation of the Development Compensation Payment in a Quarter
would be:

       
Development Balance at the end of the Quarter
    ***  
U.S. Profit Split payable to Regeneron
    ***
Rest of World Profit Split payable to Regeneron
    ***
Regeneron Profit Split
    ***
*****
    ***
Development Compensation Payment
    **

For the avoidance of doubt, the Development Costs for and Opt-Out Product until
the time such Opt-Out Product becomes an Opt-Out Product are included in the
calculation of the Development Balance.
IV. REGENERON REIMBURSEMENT AMOUNT
The “Regeneron Reimbursement Amount” for a Quarter shall mean *******
An example of a calculation of the Regeneron Reimbursement Amount in a Quarter
would be:

         
Regeneron Shared Commercial Expenses in the U.S.
    ****  
Regeneron Shared Commercial Expenses in ROW
    ****  
Regeneron Other Shared Expenses in the U.S.
    ****  
Regeneron Other Shared Expenses in ROW
    ****  
Regeneron Development Costs under a Global Development Plan
    ****  
Shared Phase 3 Trial Costs Balance
    ****    
 
       
Regeneron Reimbursement Amount
    ****  

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V. EXAMPLE OF QUARTERLY TRUE-UP
An example of a calculation of the Quarterly True-Up in a Quarter would be:

         
U.S. Profit Split Payable to Regeneron
      ***
ROW Profit Split Payable to Regeneron
      ***
Development Compensation Payment
      ***
Regeneron Reimbursement Amount
      ****  
 
       
Quarterly True-Up
      ***

In this example, Sanofi would pay Regeneron *** in accordance with the terms set
forth in Article 9.

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SCHEDULE 3
Sales Milestones

      Aggregate annual Net Sales   of all Licensed Products     in Rest of World
Countries   Sales Milestone
US$1 billion
  ************
 
   
**********
  ***********
 
   
**********
  ***********
 
   
*********
  **********
 
   
********
  **********

For purposes of clarification, each of the foregoing milestone payments shall be
made only once and only upon the first occurrence of each milestone. Aggregate
annual Net Sales of Licensed Products shall be determined based on the aggregate
Net Sales of all Licensed Products in Rest of World Countries in any rolling
twelve (12) month period.

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SCHEDULE 4
Termination Arrangements
     The rights and obligations set forth in this Schedule 4 shall apply only to
the extent of the applicable termination of this Agreement, and accordingly such
rights and obligations shall apply only with respect to the applicable
Terminated Licensed Product(s) as to which, and, if applicable pursuant to
Section 19.2(a)(ii), only in the country or countries in which, this Agreement
has been terminated.
     1. Sanofi shall promptly collect and return, and cause its Affiliates and
Sublicensees to collect and return, to Regeneron or, at Regeneron’s request,
destroy, all documents containing New Information or Party Information directly
related to any Terminated Licensed Product(s), and shall immediately cease, and
cause its Affiliates and Sublicensees to cease, all further use of any such New
Information or Party Information with respect to any Terminated Licensed
Product(s). In addition, at Regeneron’s request, Sanofi shall collect and
transfer to Regeneron any remaining inventory of Promotional Materials, sales
training materials, samples, and product inventory. Notwithstanding the
foregoing, Sanofi may retain copies of any Party Information or New Information
to the extent required by Law, as well as retain one (1) copy of such
information solely for legal archive purposes.
     2. Regeneron and its Affiliates shall have a worldwide, fully paid-up,
royalty-free (other than any royalties due for any Royalty Products under the
Discovery Agreement and any amounts payable to Third Parties for any
intellectual property or technology contributed to the Discovery Program or
Collaboration by Sanofi), exclusive right and license, with the right to
sublicense unless otherwise restricted by any License, under the Sanofi
Intellectual Property existing at the time notice of termination was given or at
the effective date of termination solely for the purpose of Developing,
Manufacturing and Commercializing Terminated Licensed Product(s) in the Field in
the Territory (and solely to the extent such Sanofi Intellectual Property has,
as of the date notice of termination was given, actually been incorporated into
such Licensed Product(s) or otherwise claims or covers its use), with all other
rights to such Sanofi Intellectual Property retained by Sanofi).
     3. Sanofi shall use Commercially Reasonable Efforts to provide all
cooperation and assistance reasonably requested by Regeneron to enable Regeneron
(or its nominee) to assume with as little disruption as reasonably possible, the
continued Development, Manufacture, and Commercialization of the Terminated
Licensed Product(s) in the Field in the Territory. Such cooperation and
assistance shall be provided in a prompt and timely manner (having regard to the
nature of the cooperation or assistance requested) and shall include, without
limitation, the following:
          (a) Sanofi shall transfer and assign to Regeneron (or its nominee) all
Marketing Approvals, Pricing Approvals, and other regulatory filings (including
Registration Filings) made or obtained by Sanofi or its Affiliates or any of its
Sublicensees to the extent specifically relating to the Terminated Licensed
Product(s).

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          (b) Sanofi shall assign and transfer to Regeneron (or its nominee)
Sanofi’s entire right, title and interest in and to all Product Trademarks for
any Terminated Licensed and Promotional Materials relating to the Terminated
Licensed Product(s); provided that nothing herein is intended to convey any
rights in or to Sanofi’s corporate name and logos or any trade names except for
the limited rights set forth herein.
          (c) Sanofi shall provide to Regeneron (or its nominee) a copy (or
originals to the extent required by any Regulatory Authority in connection with
the Development, Manufacture or Commercialization of the Terminated Licensed
Product(s) in the Field in the Territory) of all information (including any New
Information) in its possession or under its control to the extent directly
relating to the Terminated Licensed Product(s) in the Field, including, without
limitation, all information contained in the regulatory and/or safety databases,
all in the format then currently maintained by Sanofi, or such other format as
may be reasonably requested by Regeneron.
          (d) Sanofi shall use Commercially Reasonable Efforts to assign to
Regeneron any applicable sublicenses to the extent related to the Terminated
Licensed Product(s) and/or contracts relating to significant services to be
performed by Third Parties to the extent related to the Development, Manufacture
or Commercialization of the Terminated Licensed Product(s) in the Field in the
Territory, as reasonably requested by Regeneron.
          (e) Without limitation of Sanofi’s other obligations under this
Schedule 4, to the extent Sanofi or its Affiliate is Manufacturing (in whole or
in part) the Terminated Licensed Product(s) for use in the Field in accordance
with a Manufacturing Plan (or is designated to assume such responsibilities),
Sanofi (or its Affiliate) will perform such Manufacturing responsibilities and
supply Regeneron with Clinical Supply Requirements and/or Commercial Supply
Requirements of such Terminated Licensed Product(s), and Regeneron shall
purchase such Terminated Licensed Product(s), at the same price, and on such
other terms and conditions on which Sanofi was supplying, or in the absence of
termination would have been required to supply, such Terminated Licensed
Product(s), through the second anniversary of the effective date of termination
of this Agreement with respect to such Terminated Licensed Product(s) or such
shorter period if Regeneron notifies Sanofi that Regeneron is able to
Manufacture or have Manufactured such Terminated Licensed Product(s) on
comparable financial terms.
     4. Without limitation of the generality of the foregoing, the Parties shall
use Commercially Reasonable Efforts to complete the transition of the
development, manufacture, and commercialization of the Terminated Licensed
Product(s) in the Field hereunder to Regeneron (or its sublicensee or Third
Party designee) as soon as is reasonably possible.
     5. For the avoidance of doubt, except as expressly provided in the
Discovery Agreement or this Agreement, Regeneron shall not be required to
provide Sanofi any consideration in exchange for the licenses or other rights
granted to it pursuant to the provisions of this Schedule 4; provided, however,
that Regeneron shall be solely responsible for paying any royalties, fees or
other consideration that Sanofi may be obligated to pay to a Third Party in
respect of any such transfer or sublicense to Regeneron of such licenses or
other rights.

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SCHEDULE 5
Termination Arrangements
     The rights and obligations set forth in this Schedule 5 shall apply only to
the extent of the applicable termination of this Agreement, and accordingly such
rights and obligations shall apply only with respect to the applicable
Terminated Licensed Product(s) as to which this Agreement has been terminated.
     1. Regeneron shall promptly collect and return, and cause its Affiliates
and sublicensees to collect and return, to Sanofi or, at Sanofi’s request,
destroy, all documents containing New Information or Party Information of Sanofi
and its Affiliates directly related to any Opt-Out Products, and shall
immediately cease, and cause its Affiliates and Sublicensees to cease, all
further use of any such New Information or Party Information with respect to the
Terminated Licensed Product(s). In addition, at Sanofi’s request, Regeneron
shall collect and transfer to Sanofi any remaining inventory of Promotional
Materials, sales training materials, product samples and product inventory.
Notwithstanding the foregoing, Regeneron may retain copies of any Party
Information or New Information to the extent required by Law, as well as retain
one (1) copy of such information solely for legal archive purposes.
     2. Sanofi and its Affiliates shall have a worldwide, fully paid-up,
royalty-free (other than for amounts payable to Third Parties for any
intellectual property or technology contributed to the Discovery Program or
Collaboration by Regeneron), exclusive right and license, with the right to
sublicense unless otherwise restricted by any License, under the Regeneron
Intellectual Property existing at the time notice of termination was given or at
the effective date of termination solely for the purpose of Developing,
Manufacturing, and Commercializing the Terminated Licensed Product(s) in the
Field in the Territory (and solely to the extent such Regeneron Intellectual
Property has, as of the date notice of termination was given, actually been
incorporated into such Licensed Product(s) or otherwise claims or covers its
use), with all other rights to such Regeneron Intellectual Property retained by
Regeneron.
     3. Regeneron shall use Commercially Reasonable Efforts to provide all
cooperation and assistance reasonably requested by Sanofi to enable Sanofi (or
its nominee) to assume with as little disruption as reasonably possible, the
continued Development, Manufacture and Commercialization of the Terminated
Licensed Product(s) in the Field in the Territory. Such cooperation and
assistance shall be provided in a prompt and timely manner (having regard to the
nature of the cooperation or assistance requested) and shall include, without
limitation, the following:
          (a) Regeneron shall transfer and assign to Sanofi (or its nominee) all
Marketing Approvals, Pricing Approvals and other regulatory filings (including
Registration Filings) made or obtained by Regeneron or its Affiliates or any of
its sublicensees to the extent specifically relating to the Terminated Licensed
Product(s).

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          (b) Regeneron shall assign and transfer to Sanofi (or its nominee)
Regeneron’s entire right, title and interest in and to all Product Trademarks
for the Terminated Licensed Product(s) and Promotional Materials relating to the
Terminated Licensed Product(s); provided that nothing herein is intended to
convey any rights in or to Regeneron’s corporate name and logos or any trade
names except for the limited rights set forth herein.
          (c) Regeneron shall provide to Sanofi (or its nominee) a copy (or
originals to the extent required by any Regulatory Authority in connection with
the Development, Manufacture or Commercialization of the Terminated Licensed
Product(s) in the Field in the Territory) of all information (including any New
Information) in its possession or under its control to the extent directly
relating to the Terminated Licensed Product(s) in the Field, including, without
limitation, all information contained in the regulatory and/or safety databases,
all in the format then currently maintained by Regeneron, or such other format
as may be reasonably requested by Sanofi.
          (d) Regeneron shall use Commercially Reasonable Efforts to assign to
Sanofi any applicable sublicenses to the extent related to the Terminated
Licensed Product(s) and/or contracts relating to significant services to be
performed by Third Parties to the extent related to the Development, Manufacture
or Commercialization of the Terminated Licensed Product(s) in the Field in the
Territory, as reasonably requested by Sanofi.
          (e) Without limitation of Regeneron’s other obligations under this
Schedule 5, to the extent Regeneron or its Affiliate is Manufacturing (in whole
or in part) the Terminated Licensed Product(s) for use in the Field in
accordance with a Manufacturing Plan (or is designated to assume such
responsibilities), Regeneron (or its Affiliate) will perform such Manufacturing
responsibilities and supply Sanofi with Clinical Supply Requirements and/or
Commercial Supply Requirements of such Terminated Licensed Product(s), and
Sanofi shall purchase such Terminated Licensed Product(s), at the same price,
and on such other terms and conditions on which Regeneron was supplying, or in
the absence of termination would have been required to supply, such Terminated
Licensed Product(s), through the second anniversary of the effective date of
termination of this Agreement with respect to such Terminated Licensed
Product(s) or such shorter period if Sanofi notifies Regeneron that Sanofi is
able to Manufacture or have Manufactured such Terminated Licensed Product(s) on
comparable financial terms.
     4. Without limitation of the generality of the foregoing, the Parties shall
use Commercially Reasonable Efforts to complete the transition of the
Development, Manufacture and Commercialization of the Terminated Licensed
Product(s) in the Field hereunder to Sanofi (or its Sublicensee or Third Party
designee) as soon as is reasonably possible.
     5. For the avoidance of doubt, Sanofi shall not be required to provide
Regeneron any consideration in exchange for the licenses or other rights granted
to it pursuant to the provisions of this Schedule 5; provided, however, that
Sanofi shall be solely responsible for paying any royalties, fees or other
consideration that Regeneron may be obligated to pay to a Third Party in respect
of any such transfer or sublicense to Sanofi of such licenses or other rights.

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SCHEDULE 6
Notices

         
(a)
  If to Sanofi or Sanofi Amerique:    
 
       
 
  Aventis Pharmaceuticals Inc
200 Crossing Boulevard
Bridgewater
New Jersey 08807
USA
Attention: President R&D
Copy: General Counsel    
 
       
 
  With a copy to:    
 
       
 
  sanofi-aventis
174 Avenue de France
Paris, France 75017
Attention: General Counsel    
 
       
(b)
  If to Regeneron:    
 
       
 
  Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
U.S.A.
Attention: President Copy: General Counsel
   
 
       
 
  With a copy to:    
 
       
 
  Skadden, Arps, Slate, Meagher & Flom LLP
One Beacon Street, 31st Floor
Boston, Massachusetts 02108
Attention: Kent A. Coit    

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