EX-10.1



 





Exhibit 10.1




LICENSE AND COLLABORATION AGREEMENT




By and Between




BAYER HEALTHCARE LLC




and




REGENERON PHARMACEUTICALS, INC.




Dated as of October 18, 2006





 









 








TABLE OF CONTENTS




	 	 	 	 	 
	ARTICLE I DEFINITIONS
	 	 	1	 
	 
	 	 	 	 
	1.1 “Affiliate”
	 	 	1	 
	1.2 “Agreement”
	 	 	2	 
	1.3 “Anticipated First Commercial Sale”
	 	 	2	 
	1.4 “Approval”
	 	 	2	 
	1.5 “Aventis”
	 	 	2	 
	1.6 “Aventis Agreement”
	 	 	2	 
	1.7 “Business Day”
	 	 	2	 
	1.8 “Change of Control”
	 	 	2	 
	1.9 “Class A Stock”
	 	 	3	 
	1.10 “Clinical Supply Cost”
	 	 	3	 
	1.11 “Clinical Supply Requirements”
	 	 	3	 
	1.12 “COGS”
	 	 	3	 
	1.13 “Commercialize” or “Commercialization”
	 	 	3	 
	1.14 “Commercial Overhead Charge”
	 	 	3	 
	1.15 “Commercially Reasonable Efforts”
	 	 	4	 
	1.16 “Commercial Supply Cost”
	 	 	4	 
	1.17 “Commercial Supply Requirements”
	 	 	4	 
	1.18 “Committee”
	 	 	4	 
	1.19 “Common Stock”
	 	 	5	 
	1.20 “Company Excluded Territory Intellectual Property”
	 	 	5	 
	1.21 “Company Intellectual Property”
	 	 	5	 
	1.22 “Company Patent Rights”
	 	 	5	 
	1.23 “Consolidated Payment Report”
	 	 	5	 
	1.24 “Contract Year”
	 	 	5	 
	1.25 “Controlling Party”
	 	 	5	 
	1.26 “Country Commercialization Budget”
	 	 	5	 
	1.27 “Country Commercialization Plan”
	 	 	6	 
	1.28 “Country Commercialization Report”
	 	 	6	 
	1.29 “CPI”
	 	 	6	 
	1.30 “Develop” or “Development”
	 	 	6	 
	1.31 “Development Costs”
	 	 	6	 
	1.32 “Development FTE Cost”
	 	 	7	 
	1.33 “Development FTE Rate”
	 	 	8	 
	1.34 “Development Plan(s)”
	 	 	8	 
	1.35 “Effective Date”
	 	 	8	 
	1.36 “EMEA”
	 	 	8	 
	1.37 “Excluded Territory”
	 	 	8	 
	1.38 “Executive Officers”
	 	 	8	 
	1.39 “Existing Licenses”
	 	 	8	 
	1.40 “FDA”
	 	 	8	 
	1.41 “Field”
	 	 	8	 
	1.42 “Finished Product”
	 	 	8	 
	1.43 “First Commercial Sale”
	 	 	8	 
	 
	 	 	 	 
	i







 









 






	 	 	 	 	 
	1.44 “Formulated Bulk Product”
	 	 	9	 
	1.45 “FTE”
	 	 	9	 
	1.46 “GAAP”
	 	 	9	 
	1.47 “Global Development Budget”
	 	 	9	 
	1.48 “Global Development Plan”
	 	 	9	 
	1.49 “Good Practices”
	 	 	9	 
	1.50 “Governmental Authority”
	 	 	9	 
	1.51 “IAS/IFRS”
	 	 	9	 
	1.52 “ICH”
	 	 	9	 
	1.53 “IND”
	 	 	9	 
	1.54 “Joint Patent Rights”
	 	 	10	 
	1.55 “Know-How”
	 	 	10	 
	1.56 “Law” or “Laws”
	 	 	10	 
	1.57 “Lead Regulatory Party”
	 	 	10	 
	1.58 “Legal Dispute”
	 	 	10	 
	1.59 “Licensed Products”
	 	 	10	 
	1.60 “Major Market Country”
	 	 	10	 
	1.61 “Manufacture” or “Manufacturing”
	 	 	10	 
	1.62 “Marketing Approval”
	 	 	10	 
	1.63 “Medical Affairs Cost”
	 	 	10	 
	1.64 “Medical Affairs FTE Rate”
	 	 	11	 
	1.65 “Net Sales”
	 	 	11	 
	1.66 “New Information”
	 	 	12	 
	1.67 “New License”
	 	 	13	 
	1.68 “Other Shared Expenses”
	 	 	13	 
	1.69 “Out-of-Pocket Costs”
	 	 	13	 
	1.70 “Party Information”
	 	 	13	 
	1.71 “Patent Application”
	 	 	13	 
	1.72 “Patent Rights”
	 	 	13	 
	1.73 “Patents”
	 	 	13	 
	1.74 “Person”
	 	 	13	 
	1.75 “Phase 2 Trial”
	 	 	13	 
	1.76 “Phase 3 Trial”
	 	 	13	 
	1.77 “Plan”
	 	 	14	 
	1.78 “Pre-Launch Marketing Expenses”
	 	 	14	 
	1.79 “Pricing Approval”
	 	 	14	 
	1.80 “Product”
	 	 	14	 
	1.81 “Product Trademark”
	 	 	14	 
	1.82 “Promotional Materials”
	 	 	14	 
	1.83 “Quarter” or “Quarterly”
	 	 	14	 
	1.84 “Regeneron Excluded Territory Intellectual Property”
	 	 	14	 
	1.85 “Regeneron Intellectual Property”
	 	 	15	 
	1.86 “Regeneron Patent Rights”
	 	 	15	 
	1.87 “Regeneron Products”
	 	 	15	 
	1.88 “Region”
	 	 	15	 
	1.89 “Registration Filing”
	 	 	15	 
	 
	 	 	 	 
	ii







 









 






	 	 	 	 	 
	1.90 “Regulatory Authority”
	 	 	15	 
	1.91 “Rest of World Country”
	 	 	15	 
	1.92 “Sales Force Cost”
	 	 	15	 
	1.93 “Sales Force FTE Rate”
	 	 	15	 
	1.94 “Shared Promotion Expenses”
	 	 	16	 
	1.95 “Shares of Then Outstanding Capital Stock”
	 	 	17	 
	1.96 “Sublicensee”
	 	 	17	 
	1.97 “Territory Commercialization Budget”
	 	 	17	 
	1.98 “Territory Commercialization Plan”
	 	 	17	 
	1.99 “Territory”
	 	 	17	 
	1.100 “Territory Development Plan”
	 	 	17	 
	1.101 “Territory Development Budget”
	 	 	17	 
	1.102 “Third Party”
	 	 	18	 
	1.103 “United States,” “US” or “U.S.”
	 	 	18	 
	1.104 “Valid Claim”
	 	 	18	 
	1.105 “VEGF”
	 	 	18	 
	1.106 “VEGF Trap”
	 	 	18	 
	1.107 “Additional Definitions.”
	 	 	18	 
	 
	 	 	 	 
	ARTICLE II COLLABORATION
	 	 	19	 
	 
	 	 	 	 
	2.1 Scope of Collaboration
	 	 	19	 
	2.2 Compliance With Law
	 	 	19	 
	2.3 Further Assurances and Transaction Approvals
	 	 	19	 
	2.4 Compliance with Third Party Agreements
	 	 	20	 
	2.5 Plans
	 	 	20	 
	2.6 Limitation on Exercise of Rights Outside of Collaboration.
	 	 	20	 
	2.7 Excluded Territory Activities
	 	 	22	 
	 
	 	 	 	 
	ARTICLE III MANAGEMENT
	 	 	22	 
	 
	 	 	 	 
	3.1 Committees/Management.
	 	 	23	 
	3.2 Joint Steering Committee.
	 	 	23	 
	3.3 Joint Development Committee.
	 	 	24	 
	3.4 Joint Commercialization Committee.
	 	 	25	 
	3.5 Other Committees
	 	 	27	 
	3.6 Membership
	 	 	27	 
	3.7 Meetings
	 	 	28	 
	3.8 Decision-Making
	 	 	28	 
	3.9 Project Manager
	 	 	28	 
	3.10 Resolution of Governance Matters
	 	 	28	 
	 
	 	 	 	 
	ARTICLE IV LICENSE GRANTS
	 	 	30	 
	 
	 	 	 	 
	4.1 Regeneron License Grants
	 	 	30	 
	4.2 Company License Grants
	 	 	30	 
	4.3 Sublicensing
	 	 	31	 
	4.4 No Implied License
	 	 	31	 
	4.5 Retained Rights
	 	 	31	 
	4.6 Right of Negotiation for Excluded Territory
	 	 	32	 
	 
	 	 	 	 
	iii







 









 






	 	 	 	 	 
	ARTICLE V DEVELOPMENT ACTIVITIES
	 	 	32	 
	 
	 	 	 	 
	5.1 Development of Licensed Products
	 	 	32	 
	5.2 Development Plans
	 	 	32	 
	5.3 Development Budgets
	 	 	33	 
	5.4 Development Reports
	 	 	34	 
	5.5 Review of Clinical Trial Protocols
	 	 	34	 
	 
	 	 	 	 
	ARTICLE VI COMMERCIALIZATION
	 	 	34	 
	 
	 	 	 	 
	6.1 Commercialization of Products in the Field in the Territory
	 	 	34	 
	6.2 Territory Commercialization Plan
	 	 	34	 
	6.3 Country Commercialization Plans
	 	 	35	 
	6.4 Commercialization Activities; Sharing of Commercial Information.
	 	 	36	 
	6.5 Product Pricing and Pricing Approvals in the Territory
	 	 	37	 
	6.6 Sales and Product Distribution in the Territory; Other Responsibilities
	 	 	37	 
	6.7 Commercialization Efforts
	 	 	37	 
	6.8 Contract Sales Force
	 	 	38	 
	6.9 Promotional Materials.
	 	 	38	 
	6.10 Promotional Claims/Compliance
	 	 	38	 
	6.11 Restriction on Bundling in the Territory
	 	 	38	 
	6.12 Inventory Management
	 	 	39	 
	6.13 Medical and Consumer Inquiries
	 	 	39	 
	6.14 Market Exclusivity Extensions
	 	 	39	 
	6.15 Post Marketing Clinical Trials
	 	 	39	 
	6.16 Activities outside the Collaboration
	 	 	39	 
	6.17 Restriction on Commercialization Activities
	 	 	40	 
	6.18 Exports from the Territory to the Excluded Territory.
	 	 	40	 
	 
	 	 	 	 
	ARTICLE VII CLINICAL AND REGULATORY AFFAIRS
	 	 	41	 
	 
	 	 	 	 
	7.1 Ownership of Approvals and Registration Filings.
	 	 	41	 
	7.2 Regulatory Coordination.
	 	 	41	 
	7.3 Regulatory Coordination with Third Parties
	 	 	43	 
	7.4 Regulatory Events
	 	 	44	 
	7.5 Pharmacovigilance and Product Complaints
	 	 	45	 
	7.6 Regulatory Inspection or Audit
	 	 	45	 
	7.7 Recalls and Other Corrective Actions
	 	 	46	 
	 
	 	 	 	 
	ARTICLE VIII MANUFACTURING AND SUPPLY
	 	 	46	 
	 
	 	 	 	 
	8.1 Formulated Bulk Product Supply in the Field in the Territory
	 	 	46	 
	8.2 Finished Product Supply in the Field in the Territory
	 	 	46	 
	8.3 Supply Agreement
	 	 	46	 
	8.4 Manufacturing Plans
	 	 	47	 
	8.5 Manufacturing Shortfall
	 	 	47	 
	8.6 Manufacturing Compliance
	 	 	47	 
	 
	 	 	 	 
	ARTICLE IX PERIODIC REPORTS; PAYMENTS
	 	 	48	 
	 
	 	 	 	 
	9.1 Upfront Payment and Milestone Payments.
	 	 	48	 
	 
	 	 	 	 
	iv







 









 






	 	 	 	 	 
	9.2 Development Costs.
	 	 	48	 
	9.3 Periodic Reports
	 	 	49	 
	9.4 Funds Flow
	 	 	50	 
	9.5 Invoices and Documentation
	 	 	51	 
	9.6 Payment Method and Currency
	 	 	51	 
	9.7 Late Payments
	 	 	51	 
	9.8 Taxes
	 	 	51	 
	9.9 Adjustments to FTE Rates
	 	 	52	 
	9.10 Resolution of Payment Disputes
	 	 	52	 
	9.11 Budget Overruns
	 	 	52	 
	 
	 	 	 	 
	ARTICLE X DISPUTE RESOLUTION
	 	 	53	 
	 
	 	 	 	 
	10.1 Resolution of Disputes
	 	 	53	 
	10.2 Governance Disputes
	 	 	53	 
	10.3 Legal Disputes
	 	 	53	 
	10.4 Expert Panel
	 	 	53	 
	10.5 No Waiver
	 	 	55	 
	 
	 	 	 	 
	ARTICLE XI TRADEMARKS AND CORPORATE LOGOS
	 	 	55	 
	 
	 	 	 	 
	11.1 Corporate Names
	 	 	55	 
	11.2 Selection of Product Trademarks
	 	 	55	 
	11.3 Ownership of Product Trademarks
	 	 	55	 
	11.4 Prosecution and Maintenance of Product Trademark(s)
	 	 	56	 
	11.5 License to the Product Trademark(s)
	 	 	56	 
	11.6 Use of Corporate Names
	 	 	56	 
	 
	 	 	 	 
	ARTICLE XII NEWLY CREATED INVENTIONS
	 	 	57	 
	 
	 	 	 	 
	12.1 Ownership of Newly Created Intellectual Property.
	 	 	57	 
	12.2 Prosecution and Maintenance of Patent Rights.
	 	 	58	 
	12.3 Interference, Opposition and Reissue.
	 	 	61	 
	 
	 	 	 	 
	ARTICLE XIII INTELLECTUAL PROPERTY LITIGATION
	 	 	61	 
	 
	 	 	 	 
	13.1 Third Party Infringement Suits.
	 	 	61	 
	13.2 Patent Marking
	 	 	62	 
	13.3 Third Party Infringement Claims; New Licenses.
	 	 	63	 
	 
	 	 	 	 
	ARTICLE XIV BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS
	 	 	63	 
	 
	 	 	 	 
	14.1 Books and Records
	 	 	64	 
	14.2 Audits and Adjustments.
	 	 	64	 
	14.3 GAAP/IAS/IFRS
	 	 	65	 
	 
	 	 	 	 
	ARTICLE XV REPRESENTATIONS AND WARRANTIES
	 	 	65	 
	 
	 	 	 	 
	15.1 Due Organization, Valid Existence and Due Authorization
	 	 	65	 
	15.2 Knowledge of Pending or Threatened Litigation
	 	 	65	 
	15.3 Additional Regeneron Representations and Warranties
	 	 	65	 
	15.4 Disclaimer of Warranties
	 	 	67	 
	 
	 	 	 	 
	v







 









 






	 	 	 	 	 
	15.5 Mutual Covenants
	 	 	67	 
	 
	 	 	 	 
	ARTICLE XVI CONFIDENTIALITY
	 	 	68	 
	 
	 	 	 	 
	16.1 Confidential Information.
	 	 	68	 
	16.2 Injunctive Relief
	 	 	70	 
	16.3 Publication of New Information
	 	 	70	 
	16.4 Other Publications
	 	 	70	 
	 
	 	 	 	 
	ARTICLE XVII INDEMNITY
	 	 	71	 
	 
	 	 	 	 
	17.1 Indemnity and Insurance.
	 	 	71	 
	17.2 Indemnity Procedure
	 	 	73	 
	 
	 	 	 	 
	ARTICLE XVIII FORCE MAJEURE
	 	 	75	 
	 
	 	 	 	 
	ARTICLE XIX TERM AND TERMINATION
	 	 	75	 
	 
	 	 	 	 
	19.1 Term/Expiration of Term.
	 	 	75	 
	19.2 Termination Without Cause
	 	 	75	 
	19.3 Termination For Material Breach
	 	 	76	 
	19.4 Termination for Insolvency
	 	 	77	 
	19.5 Termination for Breach of Standstill
	 	 	77	 
	19.6 [****************************]
	 	 	77	 
	19.7 Effect of Termination
	 	 	77	 
	19.8 Survival of Obligations
	 	 	78	 
	 
	 	 	 	 
	ARTICLE XX MISCELLANEOUS
	 	 	79	 
	 
	 	 	 	 
	20.1 Governing Law; Submission to Jurisdiction
	 	 	79	 
	20.2 Waiver
	 	 	79	 
	20.3 Notices
	 	 	79	 
	20.4 Entire Agreement
	 	 	80	 
	20.5 Amendments
	 	 	80	 
	20.6 Headings
	 	 	80	 
	20.7 Severability
	 	 	80	 
	20.8 Registration and Filing of the Agreement
	 	 	80	 
	20.9 Assignment
	 	 	80	 
	20.10 Successors and Assigns
	 	 	81	 
	20.11 Affiliates
	 	 	81	 
	20.12 Counterparts
	 	 	81	 
	20.13 Third-Party Beneficiaries
	 	 	81	 
	20.14 Relationship of the Parties
	 	 	82	 
	20.15 Limitation of Damages
	 	 	82	 
	20.16 Standstill Agreement
	 	 	82	 
	20.17 Termination of Standstill
	 	 	83	 
	20.18 Non-Solicitation
	 	 	84	 
	20.19 No Strict Construction
	 	 	84	 
	 
	 	 	 	 
	vi








 









 








LICENSE AND COLLABORATION AGREEMENT




          THIS LICENSE AND COLLABORATION AGREEMENT (“Agreement”), dated as of October 18, 2006
(the “Effective Date”), is by and between BAYER HEALTHCARE LLC, a Delaware limited
liability company having a principal place of business at 511 Benedict Avenue, Tarrytown, New York
10591 (“Company”), and REGENERON PHARMACEUTICALS, INC., a New York corporation having a
principal place of business at 777 Old Saw Mill River Road, Tarrytown, New York 10591
(“Regeneron”) (with each of Company and Regeneron referred to herein individually as a
“Party” and collectively as the “Parties”).




          WHEREAS, Regeneron owns and has licensed certain Patents, Know-How and other rights related to
the VEGF Trap in the Territory;




          WHEREAS, Company and its Affiliates possess knowledge and expertise in, and resources for,
developing and commercializing pharmaceutical products in the Field in the Territory; and




          WHEREAS, Regeneron and Company desire to collaborate on the Development and Manufacture of
Products in the Field, and the Commercialization of Products in the Field in the Territory under
the terms and conditions set forth herein (the “Collaboration”).




          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 “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.




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




          1.3 “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.




          1.4 “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 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.




          1.5 “Aventis” shall mean sanofi-aventis US LLC (successor in interest to Aventis
Pharmaceuticals, Inc.




          1.6 “Aventis Agreement” shall mean the Collaboration Agreement, dated as of September 3,
2003, by and between Aventis and Regeneron Pharmaceuticals, Inc., 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, and the Fourth Amendment, dated as of January 31,
2006, as the same may be further amended from time to time.




          1.7 “Business Day” shall mean a day on which commercial banking institutions in New York,
New York are open for business.




          1.8 “Change of Control” shall mean, with respect to Regeneron, any of the following events:
(a) any Person is or becomes the “beneficial owner” (as such term is used in Section 13(d) of the
Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder, except that a Person shall
be deemed to have “beneficial ownership” of all shares that any such Person has the right to
acquire, whether such right may be exercised immediately or only after the passage of time),
directly or indirectly, of a majority of the total voting power represented by all classes of
capital stock then outstanding of Regeneron normally entitled to vote in elections of directors;
(b) Regeneron consolidates with or merges into another corporation or entity, or any corporation or
entity consolidates with or merges into Regeneron, other than (i) a merger or consolidation which
would result in the voting securities of Regeneron outstanding immediately prior to such merger or
consolidation continuing to represent (either by remaining outstanding or by being converted into
voting securities of the surviving entity or any parent thereof) a majority of the combined voting
power of the voting securities of Regeneron or such surviving entity or any parent thereof
outstanding immediately after such merger or consolidation, or (ii) a




2









 




merger or consolidation effected to implement a recapitalization of Regeneron (or similar transaction) in which no Person
becomes the beneficial owner, directly or indirectly, of voting securities of Regeneron
representing a majority of the combined voting power of Regeneron’s then outstanding securities; or
(c) Regeneron conveys, transfers or leases all or substantially all of its assets to any Person
other than a wholly-owned Affiliate of Regeneron.




          1.9 “Class A Stock” shall mean the Class A Stock of Regeneron, par value $0.001 per share.




          1.10 “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 Development Plans, (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
Development Plans, (c) the Out-of-Pocket Cost and/or the Manufacturing Cost for filling, packaging
and labeling such Clinical Supply Requirements, comparator agent and/or placebo, as the case may
be, for activities contemplated under the Development Plans and (d) any VAT or similar taxes
actually paid with respect to the Manufacture or delivery of Clinical Supply Requirements.




          1.11 “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.




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




          1.13 “Commercialize” or “Commercialization” shall mean any and all activities directed to
marketing, promoting, detailing, distributing, importing, offering for sale, having sold and/or
selling a Licensed Product in the Field in the Territory, including, without limitation, market
research, pre-launch marketing and educational activities, sampling and Non-Approval Trials in the
Territory.




          1.14 “Commercial Overhead Charge” shall mean, on a country-by-country 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 eighteen (18) 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
Affairs Cost, Sales Force Cost, Other Shared Expenses or Shared Promotion Expenses.




3









 





          1.15 “Commercially Reasonable Efforts” shall mean, with respect to the efforts to be
expended by a Party with respect to any objective, reasonable, diligent, good faith efforts to
accomplish such objective as such Party would normally use to accomplish a similar objective under
similar circumstances, it being understood and agreed that such efforts shall be consistent with
the Collaboration Purpose and substantially equivalent to those efforts and resources commonly used
by a Party for a product owned by it, which product is at a similar stage in its development or
product life and is of similar market potential (taking into consideration both anticipated total
sales and overall profitability). Commercially Reasonable Efforts shall be determined on a
market-by-market and product-by-product basis in view of conditions prevailing at the time, and
evaluated taking into account all relevant factors, including without limitation, the efficacy,
safety, anticipated regulatory authority approved labeling, competitiveness of the 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 Territory Profit
Split nor other payments made or required to be made from one Party to the other under this
Agreement shall be considered in determining market potential (that is, a Party may not apply
lesser resources or efforts in support of a Licensed Product because it must pay the Territory
Profit Split or make milestone or any other payments hereunder to the other Party). By way of
example, for purposes of determining whether Company uses Commercially Reasonable Efforts to
Commercialize a Licensed Product in a Major Market Country, a basis for comparison shall be the
efforts used by Company to commercialize in such Major Market Country another Company product that
is wholly owned by Company, is at a similar stage of commercialization to the Licensed Product and
has both anticipated total sales and overall profitability to Company in such Major Market Country
substantially similar to that of the Licensed Product, taking into account total sales and total profitability of the Licensed Product
in such Major Market Country, but without consideration of any of the payments required to be made
from one Party to the other under this Agreement.




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




          1.17 “Commercial Supply Requirements” shall mean, with respect to each Licensed Product,
quantities of Finished Product as are required by Company to fulfill its (or its Affiliate’s or
Sublicensee’s) requirements for commercial sales, Non-Approval Trials and Product sampling with
respect to such Licensed Product in the Field in the Territory.




          1.18 “Committee” means any of the JSC, JDC, JCC or JFC, each as described in Article 3
(together with Working Groups or other committees contemplated herein or established in accordance
with this Agreement).




4









 





          1.19 “Common Stock” shall mean the common stock of Regeneron, par value $0.001 per share.




          1.20 “Company Excluded Territory Intellectual Property” shall mean Company Patent Rights
and Know-How that cover, claim or are used for the Development, Manufacture and/or
Commercialization of Regeneron Products under the Plans, but excluding (a) any Company Patent
Rights covering the composition of any Company Products, and (b) any New Information or Party
Information arising from the Development, Manufacture and/or Commercialization of Company Products.




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




          1.22 “Company 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 Company
or any of its Affiliates (other than pursuant to this Agreement), including, without limitation,
Patent Rights covering any formulation and delivery technologies, 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 Product in the Field.




          1.23 “Consolidated Payment Report” shall mean a consolidated Quarterly report prepared by
Company (based on information reported under Sections 5.4 and 9.3) 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 Promotion Expenses
incurred by each Party for such Quarter, (b) Development Costs incurred by each Party for such
Quarter under the Global Development Plan and the Territory Development Plan, (c) Other Shared
Expenses incurred by each Party for such Quarter, including the allocation of global costs pursuant
to Section 3.4(b)(xii), (d) Commercial Supply Costs incurred by each Party for such Quarter and (e)
the Quarterly True-Up, and the component items and calculations in determining such Quarterly
True-Up, calculated in accordance with Schedule 2.




          1.24 “Contract Year” shall mean the period beginning on the Effective Date and ending on
December 31, 2007, 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.




          1.25 “Controlling Party” shall mean Regeneron with respect to the filing, prosecution and
maintenance of a Joint Patent Right that claims or covers a Regeneron Product (or the Manufacture
or use thereof), and Company in the case of all other Joint Patent Rights.




          1.26 “Country Commercialization Budget” shall mean the three-year rolling budget(s)
approved by the JCC for a particular Country Commercialization Plan.




5









 





          1.27 “Country Commercialization Plan” shall mean, for each Major Market Country in the
Territory, the three-year rolling plan for Commercializing Licensed Products in the Field in such
country, including the applicable Country Commercialization Budget, developed and approved by the
JCC, as the same may be amended from time-to-time in accordance with the terms of this Agreement.
Each Country Commercialization Plan shall set forth, for each Licensed Product, the information,
plans and forecasts set forth in Section 6.3.




          1.28 “Country Commercialization Report” shall mean, for each Major Market Country in the
Territory, a written report summarizing the marketing, detailing, selling and promotional
activities undertaken by Company (or its Affiliate) during the previous Quarter in connection with the applicable Country Commercialization
Plan, including the number of details for the Licensed Product in the Field in the country,
together with a detailed project-level statement of Shared Promotion Expenses (calculated in U.S.
dollars and local currency) incurred by Company (or its Affiliate) during such Quarter in the
country.




          1.29 “CPI” for the Excluded Territory shall mean the Consumer Price Index – Urban Wage
Earners and Clerical Workers, U.S. City Average, All Items, 1982-1984 = 100, published by the
United States Department of Labor, Bureau of Statistics (or its successor equivalent index). For
countries and Regions in the Territory (other than Japan), “CPI” shall mean the “EU15 CPI” (or its
successor equivalent index), which is published monthly and available via Bloomberg Professional,
as published by Bloomberg L.P. In Japan, “CPI” shall mean such other inflation measure or rate
agreed upon by the Parties.




          1.30 “Develop” or “Development” shall mean (a) activities directly and specifically
relating to research, pre-clinical and clinical drug development of a 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, submission and maintenance of Registration Filings and Approvals
(including post-marketing clinical trials imposed by applicable Law or as required by a Regulatory
Authority) and activities necessary to obtain a Pricing Approval, reimbursement and/or listing on
health care providers’ and payers’ formularies, and (b) any other development activities with
respect to a Licensed Product in the Field, including, without limitation, activities to support
new product formulations, delivery technologies and/or new indications in the Field either before
or after the First Commercial Sale.




          1.31 “Development Costs” shall mean costs incurred by a Party in connection with the
Development of Licensed Products in the Field in accordance with this Agreement and the Development
Plan(s) (or prior to the first Development Plan, the Initial Development Plan), including without
limitation:




6









 






(a) all Out-of-Pocket Costs, including, without limitation, fees and expenses
associated with obtaining and maintaining Registration Filings and Approvals
(including Pricing 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;




(d) the costs and expenses incurred in connection with (i) Manufacturing process,
formulation, cleaning, and shipping development and validation, (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, 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) Pre-Launch Marketing Expenses;




(f) any license fees and other payments under Existing Licenses and New 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
(which, for the avoidance of doubt, include activities in the Excluded Territory
performed under the Global Development Plan); and




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



          For clarity, it is the intent of the Parties that costs included in the foregoing will not be
unfairly allocated to the Licensed Products in the Field (to the extent that any development cost
is attributable, in part, to products or activities outside the scope of this Agreement). For the
avoidance of doubt, [***********************************************] and as defined therein shall
be considered a Development Cost under the Global Development Plan under this Agreement




          1.32 “Development FTE Cost” shall mean, for all Development activities performed in
accordance with the Development Plan(s), including regulatory activities, the




7









 




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.




          1.33 “Development FTE Rate” for the Excluded Territory, the Territory (other than Japan)
and Japan shall mean [********] in the first Contract Year, such amount to be adjusted as of January 1, 2008 and
annually thereafter by the percentage increase or decrease, if any, in the applicable CPI
(determined based on the location of the Development personnel) since the Effective Date or the
latest adjustment date hereunder, whichever is later, through June 30 of the prior calendar year.
The Development 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.




          1.34 “Development Plan(s)” shall mean the Global Development Plan and the Territory
Development Plan.




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




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




          1.37 “Excluded Territory” shall mean the United States.




          1.38 “Executive Officers” shall mean the Chief Executive Officer of Regeneron and the Chief
Executive Officer of Bayer HealthCare AG, a German corporation having a principal place of business
at 51368 Leverkusen, Germany.




          1.39 “Existing Licenses” shall mean the agreements listed in Schedule 4.




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




          1.41 “Field” shall mean the treatment and/or diagnosis of any ocular disease or disorder
through the local administration of any product to the eye, including, without limitation, by
topical, intravitreal, periorbital, implants or other means of local administration to the eye.




          1.42 “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.




          1.43 “First Commercial Sale” shall mean, with respect to a Licensed Product in a country in
the Territory (or, solely for purposes of Section 19.7(c), in the Excluded 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.




8









 








          1.44 “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.




          1.45 “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 hereof shall be [********] per year.




          1.46 “GAAP” shall mean generally accepted accounting principles in the United States.




          1.47 “Global Development Budget” shall mean the three-year rolling budget(s) approved by
the JSC in the Global Development Plan.




          1.48 “Global Development Plan” shall mean the three-year rolling plan approved by the JSC
for Developing Licensed Products in the Field as part of an integrated worldwide Development
program, including the related Global Development Budget, as the same may be amended from
time-to-time in accordance with the terms of this Agreement. Global Development Plan activities
may be undertaken entirely or partially in the Excluded Territory if approved by the JSC. For the
avoidance of doubt, the Global Development Plan will not include (a) any Development activities
that are conducted or sponsored by a Party which are only required for a specific Approval in the
Territory (including activities under the Territory Development Plan) or the Excluded Territory,
(b) Non-Approval Trials or (c) any studies conducted for Pricing Approval or formulary approval.




          1.49 “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.




          1.50 “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.




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




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




          1.53 “IND” shall mean, with respect to each Licensed Product in the Field, an
Investigational New Drug Application filed with respect to such Product, as




9









 




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.




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




          1.55 “Know-How” shall mean any and all proprietary technical or scientific information,
know-how, data, test results, knowledge, techniques, discoveries, inventions, specifications,
designs, trade secrets, regulatory filings and other information (whether or not patentable or
otherwise protected by trade secret Law) which (a) are now or hereafter during the Term owned by,
licensed to or otherwise held by (i) a Party, (ii) any Affiliate of Company that is engaged in the
Development or Commercialization of Licensed Products pursuant to this Agreement or (iii) any of
Regeneron’s Affiliates, with the rights to license or sublicense the same, and (b) relate to a
Product in the Field and are necessary or useful for the Development, Manufacture or
Commercialization of a Product in the Field, including, without limitation, New Information.




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




          1.57 “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.




          1.58 “Legal Dispute” shall mean any dispute, controversy or claim related to compliance
with this Agreement or the validity, breach, termination or interpretation of this Agreement.




          1.59 “Licensed Products” shall mean Regeneron Products and Company Products.




          1.60 “Major Market Country” shall mean [******************************** and [*******].




          1.61 “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.




          1.62 “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.




          1.63 “Medical Affairs Cost” shall mean, for each country in the Territory, the product of
(a) the number of office-based FTEs supporting the coordination of Non-Approval Trials related to
the Licensed Products in the Field as agreed upon in the




10









 




Country Commercialization Plan or Territory Commercialization Plan and (b) the applicable Medical Affairs FTE Rate.




          1.64 “Medical Affairs 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 Affairs 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.




          1.65 “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 Company or its Affiliates or
Sublicensees to Third Parties, less the following deductions determined in accordance with
Company’s standard methods as generally and consistently applied by Company:





(a) normal and customary trade, cash and/or quantity discounts allowed and taken
with respect to Licensed Product sales;




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




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




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




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




(f) compulsory payments 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, insurance and other transportation charges, to the extent included in
the invoice price;




(h) tariffs, duties, excise, value-added, consumption or other taxes (other than
taxes based on income), to the extent included in the invoice price; and



11









 






(i) any other specifically identifiable costs or charges included in the gross
invoiced sales price of such Licensed Product falling within categories
substantially equivalent to those listed above.



          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 Company or its
Affiliate or Sublicensee sells such Licensed Products in the form of a combination product
containing any 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”),
Net Sales of such Combination Product for the purpose of determining the Territory Profit Split
pursuant to this Agreement will be calculated by multiplying actual Net Sales of such Combination
Product as determined in the first paragraph of this definition of “Net Sales” by the fraction
A/(A+B), where A is the invoice price of such Licensed Product if sold separately, and B is the
total invoice price of the other active ingredient(s) in the combination if sold separately. If,
on a country-by-country basis, such other active ingredient(s) in the Combination Product is not
sold separately in such country, but the Licensed Product component of the Combination Product is
sold separately in such country, Net Sales for the purpose of determining Territory Profit Split
pursuant to this Agreement for the Combination Product shall be calculated by multiplying actual
Net Sales of the Combination Product by the fraction A/C, where A is the invoice price of the
Licensed Product component if sold separately, and C is the invoice price of the Combination
Product. If, on a country-by-country basis, the Licensed Product component is not sold separately
in that country, Net Sales for the purpose of determining the Territory Profit Split pursuant to
this Agreement for the Combination Product shall be calculated by multiplying actual Net Sales of
the Combination Product by the fraction D/(D+E), where D is the fair market value of the portion of
the Combination Product that contains the Licensed Product and E is the fair market value of the
portion of the Combination Product containing the other active ingredient(s) included in such
Combination Product, as such fair market values are determined by mutual agreement of the Parties
through the JFC.




          1.66 “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 (a) either Party,(b) any
Affiliate of Company that is engaged in the Development or Commercialization of Licensed Products
pursuant to this Agreement, (c) any of Regeneron’s Affiliates or (d) 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.




12









 








          1.67 “New License” shall mean any license approved by the JSC, other than Existing
Licenses, required for the Development, Manufacture or Commercialization of any Licensed Product in
the Field under this Agreement.




          1.68 “Other Shared Expenses” shall mean those costs and expenses specifically referred to
in Sections 3.4(b)(xii), 7.7, 12.2(e), 12.3(b), 13.1(c), 13.3(b), 13.3(d) and 17.1(c) which, except
as set forth in Section 3.4(b)(xii) or elsewhere in this Agreement, shall be shared equally between
the Parties.




          1.69 “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 the applicable Plan.




          1.70 “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. For the avoidance of doubt, all confidential information disclosed by Regeneron under
the terms of the confidentiality agreement between the Parties dated July 6, 2006 is hereby deemed
Party Information of Regeneron.




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




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




          1.73 “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.




          1.74 “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.




          1.75 “Phase 2 Trial” shall mean a controlled 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.




          1.76 “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 Phase 2 Trial.




13









 








          1.77 “Plan” shall mean any Country Commercialization Plan, Territory Commercialization
Plan, Global Development Plan, Territory Development Plan, Manufacturing Plan or other plan
approved through the Committee process relating to the Development, Manufacture or
Commercialization of Licensed Products in the Field under this Agreement.




          1.78 “Pre-Launch Marketing Expenses” shall mean, on a country-by-country basis in the
Territory, with respect to each Licensed Product, all Commercialization expenses to support the
Licensed Products in the Field incurred prior to the First Commercial Sale of such Licensed Product
in the Field in the country.




          1.79 “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.




          1.80 “Product” shall mean [*******************************************]. Except as
expressly set forth herein, the defined term “Product” shall refer exclusively to any such molecule
Manufactured, Developed and/or Commercialized in the Field.




          1.81 “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.




          1.82 “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.




          1.83 “Quarter” or “Quarterly” shall refer to a calendar quarter, except that the first
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.




          1.84 “Regeneron Excluded Territory Intellectual Property” shall mean Regeneron Patent
Rights and Know-How that cover, claim or are used for the Development, Manufacture and/or
Commercialization of Company Products under the Plans, but excluding (a) any Regeneron Patent
Rights covering the composition of any Regeneron Products, including, without limitation, the VEGF
Trap, and (b) any New




14









 




Information or Party Information arising from the Development, Manufacture
and/or Commercialization of Regeneron Products.




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




          1.86 “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 pursuant to this Agreement), including, without
limitation, Patent Rights covering formulation and delivery technologies, 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 Product in the Field.




          1.87 “Regeneron Products” shall mean Products which are now or hereafter during the Term
owned by, licensed to or otherwise held by Regeneron or any of its Affiliates (other than pursuant
to this Agreement), including, without limitation, the VEGF Trap.




          1.88 “Region” shall mean [********************************] and [*******].




          1.89 “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.




          1.90 “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.




          1.91 “Rest of World Country” shall mean any country in the Territory other than the Major
Market Countries.




          1.92 “Sales Force Cost” shall mean, for a country in the Territory, the product of (a) the
number of FTEs detailing the Licensed Products in the Field in the country in accordance with the
approved Country Commercialization Plan and (b) the applicable Sales Force FTE Rate.
Notwithstanding the foregoing, neither “Sales Force Cost” nor, for clarity, “Shared Promotion
Expenses,” shall include the costs related to [*******************************************]




          1.93 “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




15









 




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
Sales Force 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.




          1.94 “Shared Promotion Expenses” shall mean the sum of the following items, in each case to
the extent attributable to Commercialization of Licensed Products in the Field in the Territory in
accordance with an approved Country Commercialization Plan or Territory 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;




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




(c) Sales Force Cost;




(d) Medical Affairs 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,
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
Territory (including, without limitation, educational expenses, advocate
development programs and symposia, and promotional materials) to the extent such
marketing, advertising and promotion (i) relate to both Licensed Products and other
Company products or (ii) relate to Licensed Products in the Field in both the
Territory and the Excluded Territory, in each case, as agreed upon in an approved
Territory Commercialization Plan or Country 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; and



16









 






(h) Commercial Overhead Charge.



          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
not be unfairly allocated to the Licensed Products in the Field in the Territory (to the extent
that any Shared Promotion 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.




          1.95 “Shares of Then Outstanding Capital Stock” shall mean, at any time, the issued and
outstanding shares of Common Stock and Class A Stock of Regeneron at such time, as well as all
capital stock issued and outstanding as a result of any stock split, stock dividend or
reclassification of Common Stock or Class A Stock distributable, on a pro rata basis, to all
holders of Common Stock and Class A Stock.




          1.96 “Sublicensee” shall mean a Third Party or an Affiliate to whom Company will have
granted a license or sublicense under Company’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 Company will have granted the right to distribute Licensed Products in the Field wherein such
distributor pays to Company a royalty (or other amount) based upon the revenues received by the
distributor for the sale (or resale) of Licensed Products by such distributor.




          1.97 “Territory Commercialization Budget” shall mean the three-year rolling budget(s)
included in the Territory Commercialization Plan.




          1.98 “Territory Commercialization Plan” shall mean the three-year rolling plan for
Commercializing the Licensed Products in the Field in the Territory approved by the JSC, including
the Territory Commercialization Budget, as the same may be amended from time-to-time in accordance
with the terms of this Agreement. The Territory Commercialization Plan shall set forth for each
Licensed Product, the information, plans and forecasts set forth in Section 6.2.




          1.99 “Territory” shall mean all the countries of the world, except the Excluded Territory.




          1.100 “Territory Development Plan” shall mean the three-year rolling plan approved by the
JSC for Developing the Licensed Products in the Field for a specific country (or countries) in the
Territory, including the related Territory Development Budget, as the same may be amended from
time-to-time in accordance with the terms of this Agreement. For the avoidance of doubt, the
Territory Development Plan will not include (a) any Development activities that are conducted as
part of the Global Development Plan or (b) Non-Approval Trials, but will include any other clinical
trials of the Licensed Products in the Field in the Territory, including any studies or other
activities conducted for Pricing Approval.




          1.101 “Territory Development Budget” shall mean the three-year rolling budget(s) approved
by the JSC in the Territory Development Plan.




17









 








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




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




          1.104 “Valid Claim” shall mean a claim (a) of any issued, unexpired Patent that has not
been revoked or held unenforceable or invalid by a decision of a court or governmental agency of
competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not
taken within the time allowed for appeal, and that has not been disclaimed or admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise or (b) of any Patent Application
that has not been cancelled, withdrawn or abandoned or pending for more than seven (7) years.




          1.105 “VEGF” shall mean vascular endothelial growth factor.




          1.106 “VEGF Trap” shall mean [*************************]




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




	 	 	 
	DEFINITION	 	SECTION/SCHEDULE
	 
	 	 
	Aggregate Regeneron Payment Amount
	 	9.2(a)
	Alliance Manager
	 	3.2(a)
	Collaboration
	 	Preamble
	Collaboration Purpose
	 	3.1(b)
	Company Products
	 	2.6
	Development Budget(s)
	 	5.3
	Development Overrun
	 	9.11
	Expert Panel
	 	0.4
	Global Brand
	 	3.4(b)(i)
	Global Development Balance
	 	Schedule 2
	Global True-Up
	 	Schedule 2
	Governance Dispute
	 	10.2
	Initial Development Plan
	 	5.2
	JCC
	 	3.1(a)
	JDC
	 	3.1(a)
	JFC
	 	3.1(a)
	JSC
	 	3.1(a)
	Joint Invention
	 	12.1(b)
	Manufacturing Cost
	 	Schedule 1
	Manufacturing Plan
	 	8.4
	Marketing Guidelines
	 	3.4(b)(v)
	Non-Approval Trials
	 	6.2(j)






18









 






	 	 	 
	DEFINITION	 	SECTION/SCHEDULE
	 
	 	 
	Non-Incurred Amount
	 	5.3
	Project Manager
	 	3.9
	Regeneron Reimbursement Amount
	 	Schedule 2
	Quarterly True-Up
	 	Schedule 2
	Term
	 	19.1(a)
	Termination Notice Period
	 	19.2
	Territory Profit Split
	 	Schedule 2
	Working Group
	 	3.1(a)






ARTICLE II

COLLABORATION




          2.1 Scope of Collaboration. The Parties will cooperate in good faith under this Agreement
and each Party will use Commercially Reasonable Efforts to Develop Licensed Products in the Field
for the purpose of Commercializing Licensed Products in the Field in the Territory. Company will
use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field in the
Territory. The Parties shall establish various Committees as set forth in Article 3 of this
Agreement to oversee and/or coordinate the Development of Licensed Products in the Field and
oversee the Commercialization of Licensed Products in the Field in the Territory, and each Party
shall, subject to the terms and conditions set forth in Article 16, 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
effectively and efficiently Develop and Manufacture Licensed Products in the Field and for Company
(and, if agreed to by Company or set forth in the Plans, Regeneron) to effectively and efficiently
Commercialize the Licensed Products in the Field in the Territory under this Agreement.




          2.2 Compliance With Law. Both Company and Regeneron, and their respective Affiliates,
shall perform their obligations under this Agreement in an effort to Develop, Manufacture and
Commercialize Licensed Products in the Field in the Territory 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




19









 




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 Existing Licenses and the New Licenses to which it is a party and
to notify the other Party of any terms or conditions in any such Existing License or New 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 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. Moreover, each Party shall take all actions reasonably necessary to ensure
the other Party’s ability to comply with (i) any such Existing License or New License (including
any such terms and conditions with which such Party is required to comply as a sublicensee), and
(ii) any such material agreement entered into pursuant to a Plan. Neither Party may terminate or
amend any Existing License, New 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.




               (a) During the Term, except as set forth in this Agreement, neither Party nor any of its
Affiliates, either alone or through any Third Party, shall Develop or Commercialize any Product
in the Field in the Territory, except pursuant to this Agreement. For the avoidance of doubt,
nothing in the preceding sentence or elsewhere in this Agreement shall limit or restrict either
Party’s right to research, develop, make, have made, use, sell, offer to sell, have sold, import
and export its Products outside the Field, including, without limitation, Regeneron’s and
Aventis’ activities under the Aventis Agreement.



               (b) If a Party (the “Proposing Party”) presents a proposal to the JDC to undertake
additional clinical trials not contemplated in a 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 the Proposing Party may, at its
option and at its sole expense, conduct such additional clinical trial(s) outside the scope of
the Development Plans; provided, however, the Proposing Party must first present the proposed
protocols and clinical trial designs to the other Party for approval, such approval not to be
unreasonably withheld or delayed and, for other than



20









 







Non-Approval Trials or trials conducted
solely for purposes of obtaining Approvals in the Excluded Territory, shall also present to the
other Party the related budgets for Clinical Supply Costs and Out-of-Pocket Costs (provided that
such budgets shall be provided for informational purposes only and may not be used to disapprove
such protocols and designs). The other Party’s representatives on the JDC may only disapprove
any such protocols or clinical trial designs for material safety reasons. If, in compliance with
this Section 2.6(b), the other Party does not approve any such protocols or clinical trial
designs for material safety reasons, the Proposing Party may not proceed with the proposed
clinical trials unless and until the dispute has been resolved as provided in Section 3.10(b)
and, if necessary, Section 10.4. In the event that the Proposing Party 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 4 of this
Agreement. For the avoidance of doubt, no consideration or reimbursement shall be paid to the
Proposing Party 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 trials
to support an Approval in the Territory, then the other Party shall be required to reimburse the
Proposing Party for [*************] of the actual Out-of-Pocket Costs and Clinical Supply Costs
incurred in connection with the conduct of such additional clinical trial(s) that are consistent
with the budgets provided to the other Party pursuant to this Section 2.6(b) (if applicable) and
the other terms of this Agreement. Nothing in this Section 2.6(b) shall permit Regeneron to
make a Registration Filing in the Territory or seek an Approval in the Territory based on any
results or data obtained in conducting the additional clinical trial(s) allowed under this
Section 2.6(b), and publication of all data and results thereof shall be subject to Article 16.



               (c) If Company determines that one of its or one of its Affiliates’ internal product
candidates constitutes a Product in the Field or if Company or its Affiliate acquires rights to a
Product in the Field in the Territory from a Third Party, Company shall promptly present a
proposal to the JDC to include such Product in the Collaboration based on the terms of this
Agreement, and, as part of such presentation, shall provide the JDC with all information with
respect to such Product reasonably available to Company and material to a decision by Regeneron’s
representatives on the JDC as to whether to approve the inclusion of such Product in the
Collaboration. If Regeneron’s representatives on the JDC, in their sole discretion, approve such
inclusion of such Product in the Collaboration as a Licensed Product, then such Product shall be
included in the Collaboration on the terms of this Agreement (such Products being referred to as
“Company Products”). If Regeneron’s representatives on the JDC, in their sole
discretion, do not approve such inclusion of such Product in the Collaboration, then, for such
Products arising from Company’s or its Affiliates’ internal research and
development activities or to which Company or its Affiliates acquire rights, Company or its
Affiliates may continue to Develop such Product in the Field in the Territory up to the
completion of Phase 2 Trials, at which time Company shall present to Regeneron’s representatives
on the JDC the available clinical data with respect to such Product for the approval by
Regeneron’s



21









 







representatives on the JDC of inclusion of such Product in the Collaboration as a
Licensed Product under the terms of this Agreement. If Regeneron’s representatives on the JDC do
not, in their sole discretion, approve the inclusion of such Product in the Collaboration on the
terms of this Agreement, then Company or its Affiliates may license or otherwise transfer rights
to such Product in the Territory in the Field to a Third Party without any further consideration
or payments to Regeneron. However, neither Company nor any of its Affiliates may participate in
the further Development or Commercialization of such Products in the Field in the Territory. For
the avoidance of doubt, any modification, derivative or new formulation of a Regeneron Product
Developed by either Party shall be considered a Regeneron Product and not a Company Product.



          2.7 Excluded Territory Activities. Notwithstanding that a Company Product or a Regeneron
Product is deemed a Licensed Product hereunder, and for the avoidance of doubt, Company shall
have the exclusive right and authority, in its discretion, to exploit Company Products in the
Field in the Excluded Territory and Regeneron shall have the exclusive right and authority, in
its discretion, to exploit Regeneron Products in the Field in the Excluded Territory, in each
case, subject only to the terms of this Agreement that expressly apply to Licensed Products in
the Field in the Excluded Territory. Each Party agrees to reasonably communicate and consult
with the other Party (through the JDC or the other Party’s representatives on the JDC, with
respect to Development activities, and through the JCC or the other Party’s representatives on
the JCC, with respect to commercialization activities) on material Development and
commercialization activities relating to Licensed Products in the Field in the Excluded
Territory. Notwithstanding the foregoing or any other provision in this Agreement, neither Party
nor any Committee shall have the right or authority to manage or control the internal operations
of the other Party or to approve, modify, impede or delay any of the other Party’s
commercialization or Development plans or activities for its Products in the Excluded Territory
(other than as contemplated under or in connection with the Global Development Plan). Each Party
shall reasonably inform the JDC or the JCC or the other Party’s representatives on the JDC or
JCC, as applicable, of (a) all material clinical and regulatory matters directly relating to its
Products in the Excluded Territory, whether or not addressed in the Global Development Plan, and
(b) any other Development or commercialization activities directly relating to its Products in
the Excluded Territory to the extent such matters or activities would be reasonably expected to
materially adversely affect, or have a material impact on, the Development or Commercialization
of Licensed Products in the Territory. To the extent any of the foregoing matters or activities
in the Excluded Territory are undertaken pursuant to the Global Development Plan, each Party
shall comply with the Global Development Plan; otherwise, the Party Developing and/or
commercializing its Product(s) in the Excluded Territory shall consider in good faith all
comments of the JDC and the JCC (or the other Party’s representatives on the JDC or JCC) with respect to such matters
and activities.




22









 





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”), a Joint Finance Committee (the “JFC”)
and such other Committees as the Parties deem appropriate. 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 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 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) Formation; Composition and Purpose. Within ten (10) days after the Effective
Date, the Parties will establish the JSC, which 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 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 3.10 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.



               (b) Specific Responsibilities. In addition to its overall responsibility for
overseeing the Collaboration, the JSC shall in particular (i) annually



23









 







review and approve the Development Plan(s), Manufacturing Plan(s) and Territory 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
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 specified in this Agreement or otherwise agreed to by the Parties.



          3.3 Joint Development Committee.




               (a) Formation; Composition and Purpose. Within ten (10) days after the Effective
Date, the Parties will establish the JDC. The purpose of the JDC shall be (i) to advise the JSC
on the strategy for the Development of Licensed Products in the Field as part of an integrated
worldwide Development program; (ii) to develop (or oversee the development of), review and
annually update and present to the JSC for approval the Development Plan(s) (and related
Development Budget(s)) and (iii) to oversee the implementation of the 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 each Party must appoint, as one of its
representatives on the JDC, its Project Manager and provided further, 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, subject to Section 2.7, the JDC shall
be responsible for:




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




          (ii) facilitating an exchange of Development data between the Parties and
developing and updating the Development Plans (and related Development Budgets), as
described in Sections 5.2 and 5.3, for final approval by the JSC;




          (iii) developing (or overseeing the development of), reviewing, annually
updating and overseeing the implementation of, and compliance with, the Development
Plans (including the Development Budgets);




          (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; advising on material clinical and
regulatory matters and other Development activities in the Excluded Territory that
are reasonably expected to



24









 







materially adversely affect, or have a material impact
on, the Development of Licensed Products in the Territory; 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 Development Plans 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(f) ;




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




          (viii) 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;




          (ix) 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;




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




          (xi) considering and acting upon such other matters as are specified in this
Agreement or by the JSC.



          3.4 Joint Commercialization Committee.




               (a) Formation; Composition and Purpose. Within twenty (20) days after the Effective
Date, the Parties will establish the JCC. The purpose of the JCC shall be (i) to develop and
propose to the JDC and JSC the strategy for the Commercialization of Licensed Products in the
Field in the Territory; (ii) to discuss and advise on certain commercialization activities for
the Licensed Products in the Excluded Territory to the extent contemplated in Section 2.7; (iii) to develop (or oversee the
development of), review and annually update and present to the JSC for approval the Territory
Commercialization Plan (and related Territory Commercialization Budget); (iv) to develop (or
oversee the development of), review and annually update and approve the Country Commercialization
Plans (and related Country Commercialization Budgets) and (v) to oversee the implementation of
the Territory Commercialization Plan and the



25









 







Commercialization operational aspects of the Collaboration. The JCC shall be composed of at least two (2) senior executives of each Party.



               (b) JCC Responsibilities. In particular, subject to Section 2.7, the JCC shall be
responsible for:




          (i) recommending to the JSC whether a single brand will be used for
Commercialization of Licensed Products for one or more indications throughout the
Excluded Territory and the Territory (“Global Brand”). If the JCC agrees
that a Global Brand(s) for the Licensed Products is
desirable,[*****************************];




          (ii) developing and proposing to the JSC the strategy for the
Commercialization of the Licensed Products in the Field in the Territory;




          (iii) commencing no later than three (3) years prior to the Anticipated First
Commercial Sale anywhere in the Territory, (A) developing, and updating at least
annually, the Territory Commercialization Plans (and related Territory
Commercialization Budgets) for final approval by the JSC and (B) approving the
Country Commercialization Plan(s) (and related Country Commercialization
Budget(s));




          (iv) developing forecasts for Commercial Supply Requirements for the Territory
to enable the timely preparation of the Manufacturing Plan for review by the JSC;




          (v) developing and updating, as necessary
[*******************************************] (collectively, the items referred to
in this paragraph (v) shall be referred to as the “Marketing Guidelines”)
as part of the Territory Commercialization Plan;




          (vi) developing target profiles for the Licensed Products in the Field;




          (vii) developing (or overseeing the development of), reviewing, annually
updating and overseeing the implementation of and compliance with the Territory
Commercialization Plans (including the Territory Commercialization Budgets) and
Country Commercialization Plans (including the Country Commercialization Budgets),
including ensuring that country specific launch plans in the Territory are
consistent with the Marketing Guidelines;




          (viii) establishing, as necessary, sub-committees of the JCC;




          (ix) if the Parties agree to use a Global Brand, selecting a Product Trademark
for Licensed Products in the Field in accordance with



26









 







Section 11.2 and giving guidance on trade dress in the Field (****************************************************);




          (x) if the Parties agree to use a Global Brand,
[*****************************************************]




          (xi) developing and implementing plans and policies regarding journal and
other publications with respect to Licensed Products in the Field in concert with
the JDC;




          (xii) allocating the appropriate cost for Commercialization activities that
support the Licensed Products in the Field in the Territory and the Excluded
Territory as Other Shared Expenses and/or Shared Promotion Expenses, if applicable,
in accordance with this Agreement and assigning responsibilities and approving
budgets for such activities;




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




          (xiv) consulting on all commercialization activities for Licensed Products in
the Field in the Excluded Territory that are reasonably expected to materially
adversely affect, or have a material impact on, the Commercialization of Licensed
Products in the Territory in accordance with, and subject to, Section 2.7 and
Section 6.5; and




          (xv) considering and acting upon such other matters as are specified in this
Agreement or by the JSC or JDC.



          3.5 Other Committees. Within ten (10) days after the Effective Date, the Parties will
establish the JFC, which 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 9 and such other responsibilities
determined by the JSC. The JFC also shall respond to inquiries from the JDC and the JCC, as
needed.




          3.6 Membership. Each of the Committees shall be composed of an equal number of
representatives appointed by each of Regeneron and Company. 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 Company. Each co-chairperson shall be 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 draft minutes of each meeting within seven (7) days
thereafter and final minutes within thirty (30) days thereafter.




27









 








          3.7 Meetings. Each Committee shall hold meetings at such times as the Parties shall
determine, but in no event less frequently than every Quarter during the Term. If possible, the
meetings shall be held in person (to the extent practicable, alternating the site for such meetings
between the Parties) 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 the Products (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 Day’s prior written notice, except that emergency meetings may be called
with at least one (1) Business Day’s prior written notice.




          3.8 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.




          3.9 Project Manager. Each of Company and Regeneron shall appoint a senior representative
who possesses a general understanding of clinical, regulatory, manufacturing and marketing issues
to act as its Project Manager (“Project Manager”). Each Project Manager will be
responsible for:




               (a) coordinating the various functional activities of Company and Regeneron, as appropriate,
in developing and executing strategies and Plans for the Licensed Products in the Field in an
effort to ensure consistency and efficiency;



               (b) providing single-point communication for seeking consensus both within the respective
Party’s organization and with the other Party’s organization regarding key strategy and Plan
issues, as appropriate, including facilitating review of external corporate communications; and



               (c) identifying and raising cross-country, cross-Party and/or cross-functional disputes to
the appropriate Committee in a timely manner.



          3.10 Resolution of Governance Matters. As provided in Section 10.2, this Section 3.10
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:



28









 






          (i) in the case of any matter which cannot be resolved by the JDC, JCC, JFC or
any other committee established by the JSC, at the request of either Party, such
matter shall promptly, and in any event within five (5) Business Days (or one (1)
Business Day in the event of an urgent matter) after such request, be referred to
the JSC with a request for resolution;




          (ii) in the event a unanimous vote on any matter cannot be obtained at the JSC
within five (5) Business Days after referral to it pursuant to (i) above, except as
set forth in (iii) below, Company shall have the deciding vote with respect to
those matters described in [**********************************,]and Regeneron shall
have the deciding vote with respect to those matters described in
[***********************************]. Neither Party shall have the deciding vote
with respect to matters described in [****************************]. For the
avoidance of doubt, [*********************************************]




          (iii) notwithstanding the above, and subject to Section 7.2(f), if either
Party (the “First Party”) [*******************************************]
then such dispute shall be resolved in accordance with the dispute resolution
procedures set forth in Section 3.10(b); provided, however, that the dispute
resolution procedures set forth in Section 3.10(b) shall not apply and the terms of
subsection (ii) above shall apply (and thus, the final decision of the Party
authorized to cast the deciding vote shall be final and binding on the First Party)
if [***************************************************].



               (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 decision, unable to make a
decision due to a lack of required unanimity, and one Party is not expressly allocated decision
making authority over the matter as set forth in this Agreement, 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 good
faith, attempt to resolve the referred dispute within five (5) Business Days of receiving such
written notification, failing which, except for Legal Disputes (unless as jointly agreed by the
Parties), either Party may by written notice to the other Party require the specific issue in
dispute to be submitted for resolution by an Expert Panel pursuant to Section 10.4, if such
dispute is with respect to a Technical Development Matter.



               (c) Interim Budgets. Pending resolution by the Executive Officers of any referred
dispute under Section 3.10(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



29









 







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 3.10(c).



               (d) 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.



ARTICLE IV

LICENSE GRANTS




          4.1 Regeneron License Grants. Subject to the terms and conditions of this Agreement
(including, without limitation, Section 4.5) and any Existing License or New License to which
Regeneron is a party, Regeneron hereby grants to Company (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, import and export
Licensed Products for use in the Field in the Territory, and (b) the nontransferable (except as
permitted by Section 20.9), exclusive right and license under the Regeneron Intellectual Property
to sell and offer to sell Licensed Products in the Field in the Territory, subject to Regeneron’s
right to supply Licensed Products to Company, as contemplated by this Agreement. Company will have
the right to grant sublicenses under the foregoing license only as set forth in Section 4.3.
Subject to the terms and conditions of this Agreement and any Existing License or New License to
which Regeneron is a party, Regeneron also grants to Company the nontransferable (except as
permitted by Section 20.9), fully paid-up, royalty-free, non-exclusive, sublicensable right and
license under Regeneron Excluded Territory Intellectual Property to make, have made, use, sell,
offer to sell, have sold, import or export Company Products for use in the Field in the Excluded
Territory.




          4.2 Company License Grants. Subject to the terms and conditions of this Agreement and any Existing License or New License to
which Company or any of its Affiliates is a party, Company hereby grants to Regeneron the
nontransferable (except as permitted by Section 20.9), royalty-free, co-exclusive (with Company and
its Affiliates) right and license under the Company Intellectual Property to make, have made,
develop, use, import and export Licensed Products for use in the Field in the Territory. Subject
to the terms and conditions of this Agreement and any Existing License or New License to which
Company or any of its Affiliates is a party, Company also grants to Regeneron the nontransferable
(except as permitted by Section 20.9), fully paid-up, royalty-free, non-exclusive, sublicensable
right and license under Company Excluded Territory Intellectual Property to make, have made, use,
sell, offer to sell, have sold, import or export Regeneron Products for use in the Field in the
Excluded Territory.




30









 





          4.3 Sublicensing. Unless otherwise restricted by any Existing License or New License,
Company 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 Company 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 Existing License or New License, Regeneron will have the right to sublicense any
of its rights under the first sentence of Section 4.2 only with the prior written consent of
Company, 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 Company’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 16, and will include, with respect to
a Sublicensee of Company, an obligation of the Sublicensee to account for and report its sales of
Licensed Products to Company on the same basis as if such sales were Net Sales by Company. For the
avoidance of doubt, Regeneron shall be entitled to receive its share of the Territory 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 a
materially adverse effect on Regeneron or any of its Affiliates or any Regeneron Intellectual
Property, then Regeneron may cause Company or its Affiliate to exercise, and the Company or its
Affiliate will promptly exercise, any termination rights it may have under the sublicense with the
Sublicensee. Any sublicense agreement will provide for the termination of the sublicense or the
conversion of the sublicense to a license directly between the Sublicensee and Regeneron, at the
option of Regeneron, upon termination of this Agreement. Furthermore, any such sublicense shall
prohibit any further sublicense or assignment. Company will forward to Regeneron a complete copy
of each fully executed sublicense agreement (and any amendment(s) thereto) within ten (10) days of
the execution of such agreement.




          4.4 No Implied License. Except as expressly provided in this Article 4 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.




          4.5 Retained Rights. With respect to the licenses granted under this Article 4, Regeneron
reserves for itself and its Affiliates and Third Party licensees under the Regeneron Intellectual
Property and Regeneron’s interest in the Joint Inventions, (a) the right to make, have made,
distribute, import, export and use Regeneron Products in the Field in the Territory exclusively for
Development purposes, and (b) the right to Manufacture and, if agreed to by Company or set forth in
any Plans, the right to Commercialize Licensed Products for use in the Field in the Territory in
accordance with this Agreement. For the avoidance of doubt, Regeneron retains all rights in
Regeneron




31









 




Intellectual Property, Regeneron’s interest in the Joint Inventions and Regeneron
Products not expressly licensed hereunder, including, without limitation the right (i) to exploit
Regeneron Intellectual Property and Regeneron’s interest in the Joint Inventions to make, have
made, use, sell, offer to sell, have sold, import or export Products for use outside the Field;
(ii) to exploit Regeneron Intellectual Property and Regeneron’s interest in the Joint Inventions to
make, have made, use, sell, offer to sell, have sold, and import and export Products for use in the
Field in the Excluded Territory and (iii) to exploit Regeneron Intellectual Property and
Regeneron’s interest in Joint Inventions for purposes unrelated to the Licensed Products in the
Field.




          4.6 Right of Negotiation for Excluded Territory. In the event that Regeneron desires to
enter into a license or co-promotion arrangement with a Third Party (other than with an Affiliate,
distributor or contract sales force) with respect to commercialization of the Regeneron Products in
the Excluded Territory, Regeneron shall grant Company a first right of exclusive negotiation for
such commercialization rights. If Regeneron desires to enter into such a commercialization
arrangement, Regeneron shall give Company written notice. Company shall have [************] to
determine and to notify Regeneron in writing whether Company desires to negotiate such a
commercialization arrangement. Failure to provide written notice to Regeneron within such
[************] period shall be deemed to be a rejection of Regeneron’s offer to negotiate for such
commercialization rights. If Company rejects Regeneron’s offer to negotiate for such
commercialization rights, or if Company accepts Regeneron’s offer to negotiate for such
commercialization rights but the Parties are unable to reach an agreement on such commercialization
arrangement, after negotiating in good faith, within [***************] of the date Regeneron
notified Company of its desire to enter into such commercialization arrangement, then Regeneron
shall have no further obligation to Company with respect to the Regeneron Products in the Excluded
Territory.




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 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.
Regeneron may conduct separate Development activities to support Regeneron Products in the Excluded
Territory, and Company may conduct separate Development activities to support Company Products in
the Excluded Territory, in each case, subject to the conditions and requirements set forth herein,
including, without limitation, Section 2.6(b).




          5.2 Development Plans. The JDC shall prepare and update Development Plans for Licensed
Products in the Field under this Agreement for approval by the JSC. Except for the first Global
Development Plan incorporating the Initial Development Plan referred to below in this Section 5.2,
an updated Global Development




32









 




Plan (and, if applicable, Territory Development Plan) 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 Development Plan will set forth the plan for
Development of each Product in the Field over at least three (3) Contract Years and will include
(a) strategies and timelines for Developing and obtaining Approvals for the Licensed Products in
the Field in the Territory and, subject to Section 2.7, the Excluded Territory, and (b) the
allocation of responsibilities for Development activities between the Parties, and/or Third Party
service providers to the extent provided by the applicable Development Plan. Each Development Plan
will be reviewed and informally updated by the JDC not less frequently than every six (6) months
for the ensuing three (3) year period. The activities agreed to by the Parties (together with the
associated estimated budget) as set forth on Schedule 5 shall constitute the initial plan for the
Development of Licensed Products in the Field under this Agreement (the “Initial Development
Plan”). No later than sixty (60) days after the Effective Date, the JDC will meet to finalize
the first Global Development Plan (which, as provided above, shall incorporate, or be substantially
consistent with, the Initial Development Plan). Until the first Global Development Plan is
approved by the JSC, the Parties will Develop the Licensed Products in the Field under this
Agreement in accordance with the Initial Development Plan, unless otherwise agreed to by the JSC.
Unless otherwise agreed to by the JDC, each update to the Development Plan(s) shall include the
activities and timelines described in or referred to in the Initial Development Plan until the
activities described therein are completed in a timely manner.




          5.3 Development Budgets. The Territory Development Plan shall include the Territory
Development Budget and the Global Development Plan shall include the Global Development Budget
(each individually, a “Development Budget” and both collectively, the “Development Budgets”) and the
Development Budgets shall be prepared, updated, reviewed and approved as part of the preparation,
update and approval of the Development Plans in accordance with this Agreement. Amendments and
updates to any Development Budgets shall not be effective without the approval of the JSC. In the
event that, during any Contract Year (the “First Year”), any Development activity expressly
provided for in the approved Development Budget to be completed during such First Year is not
completed during such First Year (to the extent incomplete, an “Incomplete Activity”) and
the full expense budgeted for such activity for such First Year is not incurred (to the extent not
incurred, a “Non-Incurred Amount”), then such Incomplete Activity shall be completed during
Contract Years following such First Year (the “Succeeding Year(s)”) and the Non-Incurred
Amount shall be included in the Development Budget for such Succeeding Year(s) as set forth in the
following sentence. If the Development Budget for such Succeeding Year(s) has not yet been
approved by the JSC, then the Non-Incurred Amount shall be included in the proposed Development
Budget for such Succeeding Year(s) without otherwise limiting any other Development activities or
any amounts related thereto, unrelated to the Incomplete Activity, which, pursuant to the
Development Plan, would have been performed during such Succeeding Year, and if the Development
Budget for the Succeeding Year(s) has been approved by the JSC, then the Development Budget for
such Succeeding Year(s) shall be revised automatically to include the Non-Incurred Amount.




33









 








          5.4 Development Reports. Within forty-five (45) days after the end of each Quarter,
Regeneron and Company 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 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 and shall be in such form, format and of such level of detail as approved
by the JFC. At the next JDC meeting held following such forty-five (45) day period, the JDC will
approve the final Development Costs which will be used in the calculation of 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
either Party pursuant to Section 2.6(b), including, without limitation, pre-approval authorizations
for Non-Approval Trials meeting established criteria. In no event will such procedures require
more than ten (10) Business Days for the JDC to accept or reject a proposed protocol and/or
clinical trial design for a clinical study to be conducted solely for purposes of obtaining an
Approval in the Excluded Territory.




ARTICLE VI

COMMERCIALIZATION




          6.1 Commercialization of 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 and in accordance with the Territory Commercialization Plan and the Country
Commercialization Plans. Except as set forth in this Agreement, Company shall bear all costs and
expenses to Commercialize the Licensed Products in the Field in the Territory.




          6.2 Territory Commercialization Plan. The Territory Commercialization Plan and all updates
and amendments thereto will be consistent with the principles of the Collaboration Purpose. The
initial Territory Commercialization Plan will be prepared by Company, with Regeneron’s
participation and input with respect to the portions of such Plan directly applicable to the Major
Market Countries, and submitted to the JCC for review and approval. Once approved by the JCC, the
Territory Commercialization Plan will be presented to the JSC for review and approval at least
[***********] before the Anticipated First Commercial Sale in the Territory. The Territory
Commercialization Plan for each subsequent Contract Year shall be updated by the JCC and approved
by the JSC at least two (2) months prior to the end of the then current Contract Year. Each
Territory Commercialization Plan 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:




34









 








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



               (b) subject to applicable Law, Licensed Product pricing guidelines in the Field in the
Territory;



               (c) the Territory Commercialization Budget;



               (d) anticipated launch dates for applicable countries in the Territory;



               (e) any global Commercialization activities that are designed to benefit the Licensed
Product in the Field in both the Territory and the Excluded Territory (including, without
limitation, such activities that relate to global branding, global market research, Licensed
Product websites and certain publication strategies);



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



               (g) strategies for the detailing and promotion of Licensed Products in the Field in the
Territory, including recommended sales force sizes in the countries in the Territory;



               (h) anticipated major advertising, public relations and patient advocacy programs for
Licensed Products in the Field in the Territory;



               (i) reimbursement and patient assistance, including [*********************************];



               (j) post-marketing clinical trials to support Commercialization of Licensed Products in the
Field in the Territory which [********************], including any such clinical trials sponsored
by Third Parties using Licensed Product supplied by the Parties (“Non-Approval Trials”);



               (k) proposed use of Third Party sales representatives, Sublicensees and/or distributors in
any country in the Territory;



               (l) target incentive product weighting and performance goals for sales representatives
detailing the Licensed Products in the Field in the Territory; and



               (m) all other Marketing Guidelines.



          6.3 Country Commercialization Plans. Each Country Commercialization Plan and all updates
and amendments thereto will be consistent with the principles of the Collaboration Purpose. The
initial Country Commercialization Plan for each Major Market Country will be prepared by Company,
with Regeneron’s participation and input, and approved by the JCC at least [**********] before the
Anticipated First Commercial Sale in the applicable Major Market Country. The Country




35









 




Commercialization Plan for each subsequent Contract Year shall be updated and approved by the JCC
at least two (2) months prior to the end of the then current Contract Year. Each Country
Commercialization Plan 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 strategy for Commercializing Licensed Products in the Field in the Major
Market Country, including Licensed Product branding, positioning, promotional materials, core
messages, pricing strategies and competitive analyses;



               (b) the Country Commercialization Budget;



               (c) anticipated launch dates for the Licensed Product in the Field in the Major Market
Country;



               (d) market and sales forecasts for the Licensed Products in the Field in the Major Market
Country in a form to be agreed between the Parties;



               (e) strategies for the detailing and promotion of Licensed Products in the Field in the
Major Market Country, including sales force and medical affairs field force sizes, the number and type of Licensed Product details to be performed
by Company sales representatives and target opinion leaders in the Major Market Country;



               (f) FTE requirements and Shared Promotion Expenses to fulfill the requirements of the
Country Commercialization Plan;



               (g) advertising, patient advocacy programs, professional symposia, public relations,
marketing, sales and promotion efforts for Licensed Products in the Field in the Major Market
Country;



               (h) reimbursement and patient assistance, including
[**************************************]; and



               (i) Non-Approval Trials (based on JDC approved protocols),
[**************************************] in support of the Licensed Products in the Field in the
Major Market Country.



          6.4 Commercialization Activities; Sharing of Commercial Information.




               (a) Company (through its Affiliates where appropriate) shall use Commercially Reasonable
Efforts to Commercialize Licensed Products in the Field in the Territory in accordance with the
Territory Commercialization Plan and the Country Commercialization Plans. Without limiting the
foregoing, Company will, as necessary, build, train and apply a field force in the Territory
necessary to



36









 







Commercialize the Licensed Products in the Field in the Territory in accordance with
the Territory Commercialization Plan and Country Commercialization Plans.



               (b) Company will use reasonable efforts to provide Regeneron with full access to Company
information directly relating to the Commercialization of the Licensed Products in the Field in
the Territory, including, without limitation, information relating to anticipated launch dates,
the development of sales targets by customer segment and territory, key market metrics, market
research, sales forecasting and modeling, sales, prescription and patient data, reimbursement and
pricing matters, and field force plans, goals, incentives and training.



               (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 from the Territory or the Excluded
Territory, as the case may be.



               (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 Product Pricing and Pricing Approvals in the Territory.
[**********************************************]. For the avoidance of doubt, (i) Regeneron shall have sole authority for determining and establishing the price and terms of
sale (including any rebates or discounts) of Regeneron Products in the Excluded Territory and
Company shall have sole authority for determining and establishing the price and terms of sale
(including any rebates or discounts) of Company Products in the Excluded Territory.




          6.6 Sales and Product Distribution in the Territory; Other Responsibilities. Company (or
its Affiliate) shall invoice and book, and appropriately record, all sales of the Licensed Products
in the Field in the Territory. Company (or its Affiliate) also shall be responsible for (a) 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, (b) handling all returns of Licensed Product sold under this Agreement and (c) handling
all aspects of ordering, processing, invoicing, collection, distribution and receivables with
respect to Licensed Products in the Field in the Territory. If Licensed Product sold in the Field
in the Territory is returned to Regeneron, it shall promptly be shipped to a facility designated by
Company. If Regeneron Product sold in the Excluded Territory is returned to Company, it shall
promptly be shipped to a facility designated by Regeneron. If Regeneron receives an order for
Licensed Product in the Field in the Territory (or Company receives an order for Regeneron Product
in the Field in the Excluded Territory), the Party erroneously receiving the order shall refer such
orders to the other Party.




          6.7 Commercialization Efforts. Company’s sales representatives in the Territory shall
provide the FTE effort and promote and detail the Licensed Products in the Field in accordance with
the approved Country Commercialization Plan (if applicable), Territory Commercialization Plan and
all applicable Laws. Company shall, at its own expense, comply with the training plan contained in
any Country Commercialization Plan.




37









 




Beginning in the Quarter of the First Commercial Sale in each
Major Market Country, Company will provide Regeneron 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 Company for its internal management purposes. Company (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
determination of Sales Force Cost and Medical Affairs Cost and the incentive compensation
requirements set forth in the Marketing Guidelines.




          6.8 Contract Sales Force. Company shall not use the services of a sales representative
employed by a Third Party without Regeneron’s prior written consent. Company will be responsible
for (a) all costs associated with retaining any such contract sales force in excess of the expected
Sales Force Cost if Company provided its own field force and for such Third Party’s compliance with
this Agreement, (b) ensuring such contract sales force’s compliance with all
applicable Laws and (c) ensuring that sales representatives in such contract sales force have
minimum skill levels customary for sales representatives in the Field at major pharmaceutical
companies in such country.




          6.9 Promotional Materials.




               (a) Company will be responsible, consistent with the Marketing Guidelines, the Territory
Commercialization Plan and the Country Commercialization Plans (as applicable), 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. 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 Company for use in the
Territory. (b) Company shall use its own corporate name and/or logo on Promotional Materials and
Licensed Product labels in connection with Commercialization of Licensed Products in the
Territory, unless otherwise mutually agreed by the Parties.



               (b)The Parties shall jointly own all rights to all Promotional Materials, including all
copyrights thereto, in the Major Market Countries.



          6.10 Promotional Claims/Compliance. Neither Company 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), Company 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 Company 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, Company agrees not to, and to require its
Affiliates and Sublicensees not to, bundle or include any Licensed




38









 




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 or (b) is inconsistent with the
Collaboration Purpose.




          6.12 Inventory Management. Company 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. Company shall be responsible for responding to
medical questions or inquiries from members of the medical and paramedical professions and
consumers regarding Licensed Products in the Field in the Territory. The Parties will work
together to formulate responses to the major inquiries, which shall be used, if possible, by
Company in the Territory and Regeneron in the Excluded Territory. If Regeneron receives questions
about Licensed Products in the Field in a country in the Territory, it shall refer such questions
to Company, and Company shall be responsible for responding thereto. If Company receives a
question about Regeneron Products in the Field in a country in the Excluded Territory (or about any
Regeneron Product outside the Field), it shall refer such questions to Regeneron, and Regeneron
shall be responsible for responding thereto.




          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
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 trial 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.




          6.16 Activities outside the Collaboration. During the Term, neither Party nor any of its
respective Affiliates, either alone or through any Third Party, shall Develop or Commercialize a
Product in the Field in the Territory except as set forth in this Agreement. In the event that (a)
Regeneron terminates this Agreement for any reason or (b) Company terminates this Agreement for any
reason other than pursuant to Section 19.3 or Section 19.4, then [***************************],
Company (nor its Affiliates or Sublicensees) shall not, directly or indirectly, Commercialize any
Products in the Field in any part of the Territory. In the event that Company terminates this
Agreement pursuant to Section 19.3 or Section 19.4, [***********************] Regeneron (nor its
respective Affiliates or Sublicensees under this Agreement) shall not, directly or indirectly,
Commercialize any Products in the Field in any part of the Territory other than Regeneron




39









 




Products as to which, as of the date notice of such termination is received by Regeneron, Regeneron has
ownership of, or a license to. A Party shall not be considered in breach of this Section 6.16
solely by reason of the acquisition by such Party of a Person (i) if such Party includes the
offending Product(s) in the licenses granted to the other Party pursuant to this Agreement or (ii)
if prior to the closing of such acquisition, the acquiring Party commits in writing to the other Party that,
promptly following the closing of such acquisition, it will divest itself of the offending rights
and/or activity, and the acquiring Party uses Commercially Reasonable Efforts to pursue such
divestiture, and in the event that such divestiture is not completed within six (6) months of the
closing of such acquisition, the acquiring Party ceases all Development, Manufacturing and/or
Commercialization, as applicable, of the offending Product(s) in the Field or includes the
offending Products(s) in the licenses granted to the other Party pursuant to this Agreement.




          6.17 Restriction on Commercialization Activities. Company agrees that it shall refrain
from pursuing a policy of directly or indirectly selling, advertising, promoting or marketing
Regeneron Products outside the Field, and, in particular, engaging in any advertising, promoting or
marketing of Regeneron Products aimed at uses outside the Field. Without limiting the foregoing, it
is agreed that the Parties shall use Commercially Reasonable Efforts to
[********************************] and each Party shall use Commercially Reasonable Efforts to
[**********************]. Company further agrees that it shall refrain from pursuing a policy of
directly or indirectly selling, advertising, promoting or marketing Licensed Products that it is
Commercializing hereunder in the Field in the Territory for sale in the Excluded Territory. Each
Party will use reasonable efforts to prevent the unauthorized importation of Licensed Products into
the Territory or Excluded Territory, as the case may be.




          6.18 Exports from the Territory to the Excluded Territory.




               (a) Company shall supply the [*******************] with Licensed Products in quantities that
are appropriate to the size of such market (not including cross-border sales).



               (b) The Parties shall discuss, as appropriate from time to time, through their respective
representatives on the JSC, any concerns either Party may have with respect to the entry of
Licensed Products into the Excluded Territory from the Territory, including
[***************************] (“Parallel Trade Concern”).



               (c) No later than ninety (90) days after Regeneron raises a Parallel Trade Concern, the
Parties hereby agree to negotiate in good faith to determine a method for the calculation of
[**************************] (the “Parallel Unit Sales”). Such Parallel Unit Sales shall
be determined based on available data, as agreed by the Parties, measuring
[*********************************]. Out-of-Pocket Costs associated with obtaining the data
required to meet Company’s obligations hereunder shall be treated as Shared Promotion Expenses.



40









 





     (d) Within fifteen (15) days after the end of any Contract Year in which Regeneron raises a
Parallel Trade Concern, Company shall provide a detailed written report, which shall include
copies of all data used to generate such report (the “Parallel Trade Report”), to Regeneron. The Parallel Trade Report shall
[*********************************]



     (e) Promptly following delivery of the Parallel Trade Report, the Parties will meet and make
a good faith effort to agree upon [*****************]



     (f) Notwithstanding anything to the contrary contained herein, nothing contained in this
Section 6.18 shall require any Party to take actions inconsistent with applicable Law.



ARTICLE VII

CLINICAL AND REGULATORY AFFAIRS




          7.1 Ownership of Approvals and Registration Filings.




               (a) Regeneron shall be the Lead Regulatory Party, and shall own all Approvals and
Registration Filings, (i) with respect to the Development of Regeneron Products in the Field in
the Excluded Territory under the Global Development Plan and (ii) with respect to any site
license for its manufacturing facilities anywhere in the world, and shall have the rights and
obligations set forth in this Article 7 with respect thereto.



               (b) During the Term, Company shall be the Lead Regulatory Party, and shall own all Approvals
and Registration Filings, (i) with respect to the Licensed Products in the Field in each country
in the Territory and (ii) with respect to any site license for its manufacturing facilities
anywhere in the world, and shall have the rights and obligations set forth in this Article 7 with
respect thereto. Company shall be the Lead Regulatory Party, and shall own all Approvals and
Registration Filings, for any Company Products in the Field in the Excluded Territory with
respect to the Development of Company Products under a Global Development Plan.



               (c) The Lead Regulatory Party shall, as reasonably necessary to permit a Party to perform
obligations under this Agreement, 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.



          7.2 Regulatory Coordination.




               (a) The Lead Regulatory Party shall oversee, monitor and coordinate all regulatory actions,
communications and filings with and submissions (including supplements and amendments thereto) to
each applicable Regulatory Authority with respect to the Licensed Product in the Field in each
jurisdiction as to



41









 







which it is the Lead Regulatory Party; provided that it shall adhere to the
obligations in this Article 7. 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 the Licensed
Products 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, (ii) to comply with Laws in connection with the Development, Manufacture and/or
Commercialization of the Licensed Products in the Field anywhere in the world, including the
Excluded Territory, and (iii) to comply with Laws with respect to the development, manufacture
and/or commercialization of Products outside the Field. 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, and, subject to Section 2.7, with
respect to the same in the Excluded Territory to the extent that such strategies, actions, and/or
communications would reasonably be expected to materially adversely affect, or have a material
impact on, the Development or Commercialization of Licensed Products in the Field in the
Territory.



               (c) Subject to Sections 2.7 and 7.2(f), 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 that directly pertain 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,
without limitation, all annual and periodic safety reports for Licensed Products in the Field).
Moreover, the Lead Regulatory Party shall consider in good faith requests from the other Party to
have up to two (2) representatives from the other Party attend (but not participate) in all
material, pre-scheduled meetings, telephone conferences and/or discussions with the Regulatory
Authorities in the Territory or, to the extent such material meetings, telephone conferences
and/or discussions pertain to the activities under the Global Development Plan, the Excluded
Territory. 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



42









 







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 the avoidance of doubt, nothing in this Section 7.2 entitles Company to attend
meetings with Regulatory Authorities in the Excluded Territory or review Registration Filings in
connection with the Development of Regeneron Products in the Excluded Territory, except as they
relate to the performance of the Global Development Plan. Subject to its obligations hereunder,
Regeneron, in its sole discretion, shall have the exclusive right (i) to seek and obtain all
Registration Filings and Approvals with respect to the Commercialization of Regeneron Products in
the Excluded Territory, (ii) to decide the final content of, and to prepare and submit, any
Registration Filings for Marketing Approval for a Regeneron Product in the Excluded Territory and
(iii) to make any submissions or conduct any meetings or discussions with Regulatory Authorities
in the Excluded Territory concerning Marketing Approval for a Regeneron Product.



               (e) For the avoidance of doubt, nothing in this Section 7.2 entitles Regeneron to attend
meetings with Regulatory Authorities in the Excluded Territory or review Registration Filings in
connection with the Development of Company Products in the Excluded Territory, except as they
relate to the performance of the Global Development Plan. Subject to its obligations hereunder,
Company, in its sole discretion, shall have the exclusive right (i) to seek and obtain all
Registration Filings and Approvals with respect to the Commercialization of Company Products in
the Excluded Territory, (ii) to decide the final content of, and to prepare and submit any,
Registration Filings for Marketing Approval for a Company Product in the Excluded Territory and
(iii) to make any submissions or conduct any meetings or discussions with Regulatory Authorities
in the Excluded Territory concerning Marketing Approval for a Company Product.



               (f) [************************************].



          7.3 Regulatory Coordination with Third Parties. Regeneron shall use Commercially
Reasonable Efforts under the Aventis Agreement (a) to allow Company and its Affiliates to reference
the filings, registrations, licenses and authorizations from or with any Regulatory Authority in
connection with Regeneron’s and Aventis’ development, manufacture and commercialization of Products
outside the Field to support the Development, Manufacture and Commercialization of Licensed
Products in the Field in the Territory under this Agreement and (b) to coordinate the exchange of
information (including, without limitation, information pertaining to pharmacovigilance,
development, manufacture and commercialization) related to Licensed Products inside and outside the
Field between Regeneron, Company and Aventis (or any other Third Party licensee of Regeneron
engaged in the development, manufacture and/or commercialization of Licensed Products outside the
Field) in order to ensure compliance with applicable Laws. It is agreed that (i) Regeneron and its
Affiliates and licensees of Regeneron Products outside the Field (including, without limitation,
Aventis) or outside the Territory shall have the right to reference the Registration Filings and/or
Approvals of the Parties for the




43









 




Regeneron Products to support their development, manufacture and commercialization of Regeneron Products outside the Field or outside the Territory and (ii) Company
and its Affiliates and licensees of Company Products outside the Field or outside the Territory
shall have the right to reference the Registration Filings and/or Approvals of the Parties for the
Company Products to support the development, manufacture and commercialization of Company Products
outside the Field or outside the Territory. Company and Regeneron shall work in good faith to
coordinate the exchange of information (including, without limitation, pharmacovigilance
information) related to Products inside and outside the Field (and inside and outside the
Territory) between Regeneron, Company and Aventis (or any other Third Party licensee of a Party
engaged in the development, manufacture and/or commercialization of Products outside the Field or
outside the Territory) in order to ensure compliance with applicable Laws. As between the Parties,
Regeneron shall have the exclusive right to communicate with Regulatory Authorities with respect to
Regeneron Products outside the Field and, subject to Section 2.7, in the Excluded Territory, and
Company will have the exclusive right to communicate with Regulatory Authorities with respect to
Company Products outside the Field and, subject to Section 2.7, in the Excluded Territory.




          7.4 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 in the Territory or Excluded
Territory, 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 in the Territory.



          Information that shall be disclosed pursuant to this Section 7.4 shall include, but not be
limited to:





          (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



44









 







extent involving matters described in clauses (a), (b) or (c) of this Section 7.4;




          (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).



          7.5 Pharmacovigilance and Product Complaints. While the Lead Regulatory Party shall be
responsible for managing pharmacovigilance and product complaints for its territory and for
formulating and implementing any related strategies, both Parties will cooperate with each other
in order to fulfill all regulatory requirements concerning drug safety surveillance and product
complaint reporting in all countries in which the Licensed Products (both in the Field and out of
the Field) are being developed, manufactured, or commercialized in the Territory or in the Excluded
Territory. Without limitation to the foregoing, the Parties shall within ninety (90) days of the
Effective Date execute a Pharmacovigilance Agreement setting forth the specific procedures to be
used by the Parties to coordinate the investigation and exchange of reports of adverse drug
experiences and Licensed Product complaints to ensure timely communication to Regulatory
Authorities and compliance with Laws.




          7.6 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.




45









 








          7.7 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 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 Formulated Bulk Product Supply in the Field in the Territory. Subject to Regeneron’s
obligations under the Aventis Agreement, Regeneron will use Commercially Reasonable Efforts to
provide an adequate and timely supply of Formulated Bulk Product for Clinical Supply Requirements
and Commercial Supply Requirements of Regeneron Product in the Field in the Territory in accordance
with the Manufacturing Plan. Regeneron may use its Manufacturing facilities or, subject to
Company’s prior written approval, such approval not to be unreasonably withheld or delayed, Company
or Third Parties to Manufacture such Formulated Bulk Product.
[********************************************.] The Formulated Bulk Product Manufactured by or on
behalf of Regeneron will be billed to Company by Regeneron at the Manufacturing Cost.




          8.2 Finished Product Supply in the Field in the Territory. The Parties, through the JSC,
will identify which Party or Third Party will perform the filling, packaging, labeling and testing
of the Formulated Bulk Product to supply Finished Product for Clinical Supply Requirements and
Commercial Supply Requirements for use in the Field under this Agreement. The Finished Product
Manufactured by or on behalf of a Party will be billed at the Manufacturing Cost to the other Party
as a Development Cost or Commercial Supply Cost, as the case may be, in accordance with Schedule 1.




          8.3 Supply Agreement. Within six (6) months after the Effective Date, 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 [*************] prior to the Anticipated First
Commercial Sale, 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 agreement containing terms and conditions regarding quality




46









 




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




          8.4 Manufacturing Plans. The Parties, through the JSC, will develop and update as
necessary, the Licensed Product Manufacturing plan (the “Manufacturing Plan”) providing for
the Manufacturing (including testing and specifications), distribution, and forecasting of Clinical
Supply Requirements under the Development Plans and Commercial Supply Requirements under the
Territory Commercialization Plan, including, if applicable, the choice of Third Party
manufacturers, fillers, packagers, and labelers. However, Regeneron will have the right to make
all decisions with respect to Manufacturing Formulated Bulk Product for Regeneron Products, subject
to Company’s prior written approval, such approval not to be unreasonably withheld or delayed.
Each Manufacturing Plan shall set forth the Licensed Product requirements over an ensuing period of
at least three (3) Contract Years. The Manufacturing Plan will include
[******************************************]. The Manufacturing Plan (including each annual update
thereto) shall be 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 shall be approved by the JSC within four
(4) months after the Effective Date. 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.




          8.5 Manufacturing Shortfall. Each Party is required to provide prompt written notice to
the other Party if it reasonably determines that it will not 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 JSC to determine what, if any (and identify and
establish, as quickly as possible, if applicable) alternative supply source of Licensed Product
should be utilized. In case of Finished Product or Formulated Bulk Product shortages, available
supplies will be allocated as between the Parties on a pro rata basis based on their forecasted
requirements for Licensed Product in the Field in the Territory and the Excluded Territory over the
relevant period; provided that priority shall be given to meeting supply requirements for countries
in which Licensed Products are in the launch phase and that, if the shortage is due solely to a
breach by Regeneron, Company’s (and, if applicable, Regeneron’s) reasonable requirements under the
Plans will be filled first in advance of filling requirements for the Excluded Territory.




          8.6 Manufacturing Compliance. Each Party will use diligent efforts to Manufacture the
Formulated Bulk Product and Finished Product supplied under this Article 8 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




47









 




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 Aventis, if applicable) involved in the
Manufacture of Licensed Products for use in the Field under this Agreement.




ARTICLE IX

PERIODIC REPORTS; PAYMENTS




          9.1 Upfront Payment and Milestone Payments.




               (a) Within five (5) Business Days of the Effective Date, Company will pay to Regeneron the
non-refundable, non-creditable amount of US $75,000,000 (which shall not be reduced by any
withholding or similar taxes).



               (b) In addition to the other payments contemplated herein, Company 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. Company shall have five (5) Business Days from the
receipt of an invoice from Regeneron related to the achievement of any such milestone to pay the
corresponding amount to Regeneron, which, in each case, shall not be reduced by any withholding
or similar taxes.



          9.2 Development Costs.




               (a) Regeneron shall be responsible for paying one hundred percent (100%) of the Development
Costs incurred by it under the Global Development Plan in 2006. In 2007, (i) the Parties shall
each pay fifty percent (50%) of the Development Costs budgeted for in the Initial Development
Plan and incurred under the Global Development Plan up to a total of US $50,000,000, and (ii)
Regeneron shall pay one hundred percent (100%) of Development Costs budgeted for in the Initial
Development Plan and incurred under the Global Development Plan in excess of US $50,000,000, up
to the amount budgeted for 2007 in the Initial Development Plan. In 2008, (i) the Parties shall
each pay fifty percent (50%) of the Development Costs budgeted for in the Initial Development
Plan and incurred under the Global Development Plan, up to a total of US $70,000,000, and (ii)
Regeneron shall pay one hundred percent (100%) of Development Costs budgeted for in the Initial Development Plan and incurred under
the Global Development Plan in excess of US $70,000,000, up to the amount budgeted for in 2008 in
the Initial Development Plan (such amount paid by Regeneron pursuant to this clause (ii),
together with the amount paid one hundred percent (100%) by Regeneron in 2007 pursuant to clause
(ii) in the preceding sentence, being referred to as the “Aggregate Regeneron Payment
Amount”). Notwithstanding the foregoing, [****************************************].
Commencing on January 1, 2009 and continuing during the Term, each of Company and Regeneron shall
be responsible for paying fifty percent (50%) of all Development Costs incurred under the Global



48









 




Development Plan in accordance with the terms of this Agreement by or on behalf of Company,
Regeneron and their respective Affiliates.




               (b) Commencing on the Effective Date and continuing during the Term, Company shall be
responsible for paying one hundred percent (100%) of the total Development Costs incurred under
the Territory Development Plan in accordance with the terms of this Agreement by or on behalf of
Company, Regeneron and their respective Affiliates.



               (c) If Company desires to use efficacy data from a clinical trial conducted by or on behalf
of Regeneron in the Excluded Territory (and outside the scope of the Global Development Plan) to
support an application for Marketing Approval (including a new label claim) for a Licensed
Product in the Field in the Territory, such trial shall be deemed to be part of the Global
Development Plan and Company shall reimburse Regeneron for [***************] of the Development
Costs incurred by Regeneron in connection with such trial, provided such clinical trial was
previously presented to Company for inclusion in the Global Development Plan pursuant to Section
2.6(b). Nothing in this subsection (c) will require Company to reimburse Regeneron for such
costs if the data is used solely as part of an annual report, periodic safety report or other
regular filing required by a Regulatory Authority in the Territory or applicable Laws.



               (d) If Regeneron desires to use efficacy data from a clinical trial conducted by or on
behalf of Company pursuant to a Territory Development Plan to support an application for
Marketing Approval (including a new label claim) for a Regeneron Product in the Field in the
Excluded Territory, such trial shall be deemed to be part of the Global Development Plan and
Regeneron shall reimburse Company for [*******************] of the Development Costs incurred by
Company in connection with such trial, provided such clinical trial was previously presented to
Regeneron for inclusion in the Global Development Plan pursuant to Section 2.6(b). Nothing in
this subsection (d) will require Regeneron to reimburse Company for such costs if the data is
used solely as part of an annual report, periodic safety report, or other regular filing required
by a Regulatory Authority in the Excluded Territory or applicable Laws.



          9.3 Periodic Reports. Company 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, Company 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, Company shall deliver
electronically to Regeneron a written report setting forth,



49









 







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 in that Quarter shall deliver electronically to the other
Party a written report setting forth in reasonable detail the Other Shared Expenses incurred by
such Party in such Quarter, 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 after the First
Commercial Sale in a country in the Territory (or such earlier agreed upon calendar Quarter, if
appropriate), Company shall provide to Regeneron, in electronic form, a Country Commercialization
Report for each country in the Territory.



               (f) Within forty-five (45) days following the end of each Quarter commencing after the First
Commercial Sale in the Territory (or such earlier agreed upon calendar Quarter, if appropriate),
each Party that has incurred any Shared Promotion Expenses in that Quarter shall deliver
electronically to the other Party a written report setting forth in reasonable detail the Shared
Promotion Expenses incurred by such Party in such Quarter;



               (g) Within forty-five (45) days following the end of each Quarter, each Party (if
applicable) shall deliver electronically to the other Party a written report setting forth
Commercial Supply Costs incurred by such Party for such Quarter; and



               (h) Within sixty (60) days following the end of each Quarter, Company 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 9 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 9.4 and, if applicable, providing for the
netting of such payments.



          All reports referred to in this Section 9.3 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.




          9.4 Funds Flow. The Parties shall make Quarterly True-Up payments as set forth in Schedule
2. If Company is the Party owing the Quarterly True-Up based on the calculations in the
Consolidated Payment Report, it shall, subject to Section 9.10, make such payment to Regeneron
within ten (10) days after its delivery to Regeneron of such Consolidated Payment Report. If
Regeneron is the Party owing the Quarterly True-Up based on the calculations in the Consolidated
Payment Report, it shall, subject to Section




50









 




9.10, make such payment to Company within ten (10)
days after its receipt of such Consolidated Payment Report from Company. Notwithstanding the
foregoing, no later than fifty-five (55) days after the end of each Quarter, Company shall pay
Regeneron fifty percent (50%) of the amount of royalties or other amounts payable under any
Existing License or New License (to the extent attributable to 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 Existing License and/or New License, as the
case may be.




          9.5 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.




          9.6 Payment Method and Currency. All payments under this Agreement shall be made by bank
wire transfer in immediately available funds to an account designated by the Party to which such
payments are due. All sums due under this Agreement shall be payable in United States Dollars. In
those cases where the amount due in United States Dollars is calculated based upon one or more
currencies other than United States Dollars, such amounts shall be converted to United States
Dollars at the average rate of exchange for the Quarter to which such payment relates, as reported
in The Bloomberg Professional, a service of Bloomberg LP, or in the event The Bloomberg
Professional does not have data available for the Quarter, then in The Wall Street Journal and by a
method of conversion consistent with Company’s customary and usual procedures used for currency
conversion in its financial statements.




          9.7 Late Payments. The Parties agree that, unless otherwise mutually agreed by the Parties
or otherwise provided in this Agreement, amounts due by one Party to the other shall be payable to
a bank account, details of which are to be communicated by the receiving Party. Unless otherwise
mutually agreed by the Parties or otherwise provided in this Agreement, all payments under this
Agreement shall earn interest, to the extent permitted by applicable
Law, from the date due until paid at a rate equal to 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”).




          9.8 Taxes. Except with respect to the payments provided for in Section 9.1, 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 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, Company agrees to make all lawful and reasonable
efforts




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to minimize any such taxes, assessments and fees and will claim on Regeneron’s behalf the
benefit of any available Treaty on the Avoidance of Double Taxation that applies to any payments
hereunder.




          9.9 Adjustments to FTE Rates. Notwithstanding anything herein to the contrary, upon the
request of either Party (such request to occur not more than once every three (3) years for any
country), the Parties shall meet to review the accuracy of an applicable FTE rate in any country
(e.g., Sales Force FTE Rate, Medical Affairs FTE Rate, Development FTE Rate, etc.). The Parties
agree to share reasonable supporting documents 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.




          9.10 Resolution of Payment Disputes. In the event there is a dispute relating to any of
the payment obligations or reports under this Article 9, 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 3.10(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.




          9.11 Budget Overruns. Notwithstanding anything to the contrary in this Agreement
(including Section 3.10(a)(ii)), neither Party shall be required (a) to pay any Development Costs that are in excess
of [**********************] of the total amounts that are in the JSC approved Global Development
Budget (or Territory Development Budget) for a Contract Year (“Development Overruns”) or
(b) to pay any Shared Promotion Expenses that are in excess of [*******************] of the total
amounts that are in the JSC approved Territory Commercialization Budget (or Country
Commercialization Budget) for a Contract Year (“Commercialization Overruns”), unless such
Development Overruns or Commercialization Overruns have been approved by both Parties’
representatives on the JSC. Otherwise, the Party responsible for the Development and/or
Commercialization activities that caused the overrun shall be responsible for bearing those costs
and expenses, or, if both Parties contributed toward the overrun, they shall bear those excess
expenses in the same proportion as their contributions to the overrun. Any such Development
Overruns or Commercialization Overruns that are not approved by both Parties’ representatives on
the JSC shall not be included in the calculation of the Regeneron Reimbursement Amount, Global
True-Up, Global Development Balance or Territory Profit Split, as applicable. For clarity, the
Parties shall share, to the extent provided in this Agreement, Development Costs and Shared
Promotion Expenses that are over the budgeted amounts in the Plans up to [************************]
of the budgeted amounts.




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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 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 3
(“Governance Disputes”) shall be resolved pursuant to Article 3 and, to the extent such
matters constitute Technical Development Matters or a dispute referred to in Section 14.2(b),
Section 10.4 (subject to, and without limitation of, the proviso in Section 3.10(a)(iii)), 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 (a) any matter involving the Development of a
Licensed Product in the Field, including the determination of clinical trial design and any
Development or regulatory dispute referred to the Executive Officers pursuant to Section
3.10(a)(iii) and (b) 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 3.10(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
or a dispute referred to in Section 14.2(b) that cannot be resolved by the Executive Officers
pursuant to Section 3.10(b) (other than a Legal Dispute or any dispute concerning any proposed
amendment to the Initial Development Plan), 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. 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. For disputes referred to the Expert
Panel arising under Section 3.10(a)(iii), the Expert Panel in resolving the dispute shall balance
the relative benefits and harm to each Party from the matter in dispute in connection with the
applicable




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Licensed Product in the Territory and Excluded Territory. 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 expert, the two-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 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 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 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



54









 







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.



          (e) In rendering the final decision (which shall be rendered no later than fifteen (15) 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 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 10 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 and in the Excluded Territory, if applicable pursuant to Section
3.4(b)(i), unless such Product Trademark is prohibited by law in any country in the Territory.
Each Licensed Product in the Field shall be promoted and sold in the Territory, and if applicable
pursuant to Section 3.4(b)(i) in the Excluded 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,
Company (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. It is understood and agreed that Regeneron
shall own and retain all right, title and interest in the Product Trademark(s) for Regeneron
Products,



55









 







together with all associated domain names and all goodwill related thereto in the
Excluded Territory.



     11.4 Prosecution and Maintenance of Product Trademark(s). Company 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
Company elects not to prosecute or maintain any Product Trademark(s) in any country in the
Territory, Regeneron shall have the right to do so on behalf of Company for use with Licensed
Products, subject to consultation and cooperation with Company.



     11.5 License to the Product Trademark(s). Company hereby grants to Regeneron a co-exclusive license to use the Product Trademark(s) for
the Licensed Products solely for the purposes of Regeneron’s Development, Manufacturing, and, if
agreed to by Company or set forth in any Plans, Commercialization activities pursuant to this
Agreement and subject to the terms and conditions of this Agreement. Company shall utilize the
Product Trademark(s) only on approved Promotional Materials 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 Company 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) 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. Company (through its Affiliates, as appropriate) shall use Commercially Reasonable Efforts to
include Regeneron’s name with equal prominence on materials exclusively 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)
in the Major Market Countries, 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 in
the Major Market Countries 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 for a maximum period of three (3) years thereafter with respect
to Promotional Materials, package inserts, packaging, labeling, trade packaging and samples solely
to the extent necessary to exhaust the existing inventory of Licensed Product and Promotional
Materials containing such name or logo. During the Term, each Party shall submit samples of each



56









 







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




     12.1 Ownership of Newly Created Intellectual Property.



          (a) Each Party (and each Party’s respective Affiliates) shall exclusively own all
intellectual property (including, without limitation, 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 Company, its Affiliates, employees, agents and
consultants are referred to herein as “Company 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.



          (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 Company
or its Affiliate (or for which ownership vests in Company 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 Company 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 Company 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 Company 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.



57









 





          (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) 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 4, (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 12 shall relieve a Party or its Affiliates of their obligations
under Article 16 with respect to confidential Party Information provided by the other Party or
such other Party’s Affiliates. Neither Party hereto shall have the duty to account to the other
Party for any revenues or profits obtained from any transfer of its interest in, or its use,
sublicense or other exploitation of, the Joint Inventions outside the scope of the Collaboration.
Each of the Parties (or its Affiliate), as joint owner of the Joint Inventions, agrees to
cooperate with any enforcement actions brought by the other joint owner(s) against any Third
Parties, and further agrees not to grant any licenses to any such Third Parties against which
such enforcement actions are brought during the time of such dispute, without the prior written
consent of the other joint owner(s), such consent not to be unreasonably withheld. The
provisions governing Joint Inventions set forth in this Section 12.1(e) shall survive the
expiration or termination of this Agreement.



     12.2 Prosecution and Maintenance of Patent Rights.



          (a) Regeneron shall use Commercially Reasonable Efforts to prepare, file, prosecute and
maintain Patents and Patent Applications (as applicable) included in the Regeneron Patent Rights
in the Territory and shall confer with and keep Company 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 Patent Applications and Patents in the Territory
included in the Regeneron Patent Rights: (i) Regeneron shall use Commercially Reasonable Efforts
to provide to Company for review and comment 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 Regeneron and consider in good faith any comment from Company;
(ii) Regeneron shall provide Company 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 Company promptly



58









 







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 and (iv) Regeneron shall consult with Company 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 Company 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, subject to any rights
granted to Aventis under the Aventis Agreement, Company shall have the right, but not the
obligation, to assume responsibility for the prosecution and maintenance thereof in Regeneron’s
name, unless, with respect to any such Patent Applications that are unpublished, Regeneron
notifies Company that Regeneron would prefer to maintain the subject matter of such Patent
Application as a trade secret.



          (b) Company shall use Commercially Reasonable Efforts to prepare, file, prosecute and
maintain Patents and Patent Applications (as applicable) included in the Company Patent Rights in
the Territory and shall confer with and keep Regeneron reasonably informed regarding the status
of such activities. In addition, Company shall have the following obligations with respect to
the filing, prosecution and maintenance of Patent Applications and Patents in the Territory
included in the Company Patent Rights: (i) Company shall use Commercially Reasonable Efforts to
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 Company and consider in good faith any comment from
Regeneron; (ii) Company shall provide Regeneron promptly with copies of all material
communications received from or filed in patent offices with
respect to such filings; (iii) Company 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 and (iv) Company shall
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 Company desires to abandon any Patent included in the Company Patent Rights in the
Territory, Company 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 Company 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 Company’s name, unless, with
respect to any such Patent Applications that are unpublished, Company notifies Regeneron that



59









 







Company would prefer to maintain the subject matter of such Patent Application as a trade
secret.



          (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. 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 use Commercially Reasonable Efforts to 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 consider in good faith any comment; (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; (iv) the
Controlling Party shall provide the non-Controlling Party promptly with copies of all
communications received from or filed in patent offices with respect to such filings; and (v) the
Controlling Party shall provide the non-Controlling Party a reasonable time prior to taking or
failing to take action that would affect the scope or validity of rights under any Patent
Applications or Patents, but in no event less than sixty (60) days prior to the next deadline for
any action that may be taken with the applicable patent office, (including but not limited to
substantially narrowing or canceling any claim without reserving the right to file a continuing
or divisional Patent Application, abandoning any Patent or not filing or perfecting the filing of
any Patent Application in any country), with notice of such proposed action or inaction so that
the non-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 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



60









 







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 Company 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
Company Patent Rights, Regeneron Patent Rights and Joint Patent Rights in the Territory for use
in the Field, and any extensions thereof, shall be shared by the Parties as part of 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, Company Patent Rights or Joint Patent
Rights in the Territory. The Parties will thereafter consult and cooperate fully to determine a
course of action with respect to any such proceeding. Decisions on whether to initiate or how to
respond to such a proceeding, as applicable, 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 Company, (ii) with respect to Company Patent Rights, by
Company in consultation with Regeneron and (iii) with respect to Joint Patent Rights, jointly by
the Parties. Regeneron may have certain obligations under Section 12.3 of the Aventis Agreement
with respect to any such proceeding
described in this Section 12.3(a) and, notwithstanding anything to the contrary herein,
Regeneron shall have the right to comply with its obligations and exercise its rights thereunder.



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



ARTICLE XIII

INTELLECTUAL PROPERTY LITIGATION




     13.1 Third Party Infringement Suits.



          (a) In the event that either Party or any of its Affiliates becomes aware of an actual or
suspected infringement of a Company Patent Right, a Regeneron Patent Right, a Joint Patent Right,
Product Trademark or any other intellectual property



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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 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. Regeneron may have certain
obligations under Article 13 of the Aventis Agreement with respect to any such actual or
suspected infringement described in this Section 13.1 and, notwithstanding anything to the
contrary herein, Regeneron shall have the right to comply with its obligations and exercise its
rights thereunder.



          (b) With respect to any infringement by virtue of a Third Party’s activities in the Field 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 (i) with respect to Regeneron Patent
Rights, by Regeneron in consultation with Company, (ii) with respect to Company Patent Rights, by
Company 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 be shared equally by the Parties,
subject to any obligations under any New License or Existing License.



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



          (d) 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.



     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.



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     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; 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. Regeneron may have
certain obligations under Article 13 of the Aventis Agreement with respect to any allegation
described in this Section 13.3 and, notwithstanding anything to the contrary herein, Regeneron
shall have the right to comply with its obligations and exercise its rights thereunder.



          (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 shared by the Parties as
Other Shared Expenses.



          (c) For the avoidance of doubt, neither Party will enter into any settlement of any suit
involving Licensed Products 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.



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



ARTICLE XIV

BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS





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     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 costs), upon no less than thirty (30) days
advance written notice and at such reasonable times and intervals and to such reasonable extent
as the investigating Party shall request, not more than once during any 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 10. 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 ten percent (10%), the audited Party shall
also reimburse the other Party for the costs of such audit (with the cost of the audit to be paid
by the auditing party in all other cases). Such accountants shall not reveal to the Party
seeking verification the details of its review, except for such information as is required to be
disclosed under this Agreement, and shall be subject to the confidentiality provisions contained
in Article 16.



          (c) If any examination or audit of the records described above discloses an under- or
over-payment of amounts due hereunder, then unless the result of the audit is to be 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.



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     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 GAAP or IAS/IFRS as generally
and consistently applied.



ARTICLE XV

REPRESENTATIONS AND WARRANTIES




     15.1 Due Organization, Valid Existence and Due Authorization. Each Party hereto represents and warrants to the other Party, as of the Effective Date, as
follows: (a) it is duly organized and validly existing under the Laws of its jurisdiction of
incorporation; (b) it has full corporate power and authority and has taken all corporate action
necessary to enter into and perform this Agreement; (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
accordance with the terms and conditions hereof (subject to applicable Laws of bankruptcy and
moratorium); (e) such Party is not prohibited by the terms of any agreement to which it is a party
from granting, the licenses granted to the other under Article 4 hereof; and (f) no broker, finder
or investment banker
is entitled to any brokerage, finder’s or other fee in connection with this Agreement or the
transactions contemplated hereby based on arrangements made by it or on its behalf. Company
additionally represents and warrants to Regeneron that it has and will continue to have the
resources and financial wherewithal to fully meet its obligations under this Agreement.



     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 and Warranties. Regeneron additionally represents and warrants to Company that, as of the Effective Date:



          (a) Regeneron has the right and authority to grant the rights and licenses granted pursuant
to the terms and conditions of this Agreement and Regeneron has not granted any rights that
remain in effect which conflict with the rights and licenses granted herein;



          (b) Except as set forth in Schedule 6, Regeneron is the sole owner of the Regeneron Patent
Rights existing at the Effective Date, to Regeneron’s knowledge, its title is free and clear of
all liens, security interests and other encumbrances



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(other than unilateral creditor filings, as
to which this representation and warranty is made only to Regeneron’s knowledge), and, except for
the joint owner identified in Schedule 6 (and with respect to the Existing Licenses, the Third
Party licensors referred to in Schedule 4), no Third Party has any right, title or interest in
the Territory in the Field with respect to the Regeneron Patent Rights existing at the Effective
Date;



          (c) It has no knowledge that the making, using or selling of the VEGF Trap in the Field in
the Territory would infringe any valid claims of the Patents of any Third Party in the Territory,
nor does it have knowledge that any Third Party is infringing or misappropriating any of the
Regeneron Intellectual Property;



          (d) There are no judgments or settlements against or owed by Regeneron with respect to the
Regeneron Intellectual Property owned by Regeneron;



          (e) There are no claims, announced investigations, actions or other proceedings pending
before or, to Regeneron’s knowledge, threatened by any Regulatory Authority or other government
agency with respect to the VEGF Trap, any Regeneron facility or, to Regeneron’s knowledge, any
other facility where the VEGF Trap is Manufactured, and Regeneron has not received written notice
threatening any such claim, investigation, action or other proceeding;



          (f) To the knowledge of Regeneron, the Development and Manufacture of VEGF Trap in the Field
has been conducted by Regeneron and its Affiliates and its subcontractors in compliance in all
material respects with applicable Laws, rules and regulations, and none of Regeneron or, to the
knowledge of Regeneron, any of its Affiliates or subcontractors have received any notice in
writing, or otherwise has knowledge of any facts, which have, or reasonably should have, led
Regeneron to believe that any of the Registration Filings relating to the VEGF Trap in the Field
are not currently in good standing with the FDA;



          (g) To Regeneron’s knowledge, neither Regeneron, nor any officer, employee or agent of
Regeneron, has made an untrue statement of a material fact to any Regulatory Authority with
respect to the VEGF Trap in the Field (whether in any submission to such Regulatory Authority or
otherwise), or knowingly failed to disclose a material fact required to be disclosed to any
Regulatory Authority with respect to the VEGF Trap in the Field;



          (h) To Regeneron’s knowledge, Regeneron and its employees, agents, clinical institutions and
clinical investigators have materially complied with all FDA statutory and regulatory
requirements with respect to VEGF Trap in the Field;



          (i) Each Existing License is, to Regeneron’s knowledge, in full force and effect as of the
Effective Date. Regeneron has, to the extent contractually permitted, provided to Company, or
allowed Company access to review, a true and complete copy of each Existing License. Regeneron
will devote Commercially Reasonable Efforts to maintain the Existing Licenses in full force and
effect and to perform its obligations thereunder and to keep Company informed of any material



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development pertaining thereto that would reasonably be expected to have a material adverse
effect on Company’s rights under this Agreement. Regeneron shall not, without the prior written
approval of Company, (i) amend any provision of an Existing License that would reasonably be
expected to have a material adverse effect on Company’s rights under this Agreement or (ii) make
any election or exercise any right or option to terminate in whole or in part any Existing
License to the extent such election or exercise would reasonably be expected to have a material
adverse effect on Company’s rights under this Agreement; and



          (j) Regeneron has made available to Company, to the extent material, (i) written preclinical
and clinical study results and protocols for the VEGF Trap in the Field, (ii) written
communications to and from FDA with respect to the VEGF Trap in the Field, including but not
limited to Registration Filings with the FDA and FDA minutes of meetings and telephone
conferences, (iii) written FDA requests for
data and studies with respect to the VEGF Trap in the Field and (iv) written reports of
adverse drug experiences and other IND safety reports with respect to the VEGF Trap in the Field.



     In reference to Section 15.3(c) above, the Parties acknowledge that they are aware of patents
and pending patent applications owned by Genentech, Inc. that claim certain chimeric VEGF receptor
compositions. Although Regeneron does not believe that the VEGF Trap infringes any valid claim in
these patents or patent applications (if they were to issue), Genentech could initiate a lawsuit
for patent infringement and assert that its patents are valid and cover the VEGF Trap. An adverse
determination by a court in any such potential patent litigation would likely require the Parties
to seek a license, which may not be available, or result in the Parties’ inability to Develop,
Manufacture or Commercialize the VEGF Trap in the Field in the Territory or in a damage award.



     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
conflict with 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



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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 Company and Regeneron acknowledges (subject to the further provisions of this
Article 16 and the provisions of Article 19) that all Party Information provided to it (or its
Affiliate) or otherwise made available to it by the other Party or its respective Affiliates
pursuant to this Agreement (or, in the case of Company, Party Information provided to it under
the confidentiality agreement between the Parties dated July 6, 2006) is confidential and
proprietary to such other Party. Furthermore, each of Company and Regeneron acknowledges
(subject to the further provisions of this Article 16) that all New Information is confidential
and proprietary to both Parties. Subject to the further provisions of this Article 16, each of
Company 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 Company 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 or any other Person under its
authorization; provided such employees, agents 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 16
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



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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.



          (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
the Regeneron Products (including the Manufacture or use thereof) (i) to Aventis or any other
Third Party licensee or contractor of Regeneron engaged in, and for use in connection with, the
development, manufacture and/or commercialization of Regeneron Products outside the Field under
substantially the same confidentiality obligations as are set forth herein, except that the
confidentiality obligations shall have a term of at least five (5) years, (ii) in connection with
Regeneron’s Development, Manufacture and/or Commercialization of Regeneron Products outside the
Field, (iii) to any Third Party licensee or contractor of Regeneron engaged in the Development,
Manufacture and/or Commercialization of Regeneron Products in the Excluded Territory under
substantially the same confidentiality obligations as are set forth herein, except that the
confidentiality obligations shall have a term of at least five (5) years, and (iv) to
Governmental Authorities or Regulatory Authorities as required by Law.



          (d) Notwithstanding anything provided above or elsewhere in this Agreement, Company and its
Affiliates shall have the right to use and disclose any New Information directly related to
Company Products (including the Manufacture or use thereof) (i) to any Third Party licensee or
contractor of Company or any of its Affiliates’ engaged in and for use in connection with the
development, manufacture and/or commercialization of Company Products outside the Field under
substantially the same confidentiality obligations as are set forth herein, except that the
confidentiality obligations shall have a term of at least five (5) years, (ii) in connection
with Company’s or any of its Affiliates’ Development, Manufacture, and/or Commercialization of
Company Products outside the Field, (iii) to any Third Party licensee or contractor of Company
engaged in the Development, Manufacture and/or Commercialization of Company Products in the
Excluded Territory under substantially the same confidentiality obligations as are set forth
herein, except that the confidentiality obligations shall have a



69









 







term of at least five (5) years
and (iv) to Governmental Authorities or Regulatory Authorities as required by Law.



     16.2 Injunctive Relief. Each Party acknowledges that damages resulting from breach of this Article 16 would not be an
adequate remedy and that, notwithstanding the provisions of Article 10, in the event of any such
disclosure or any indication of an intent to disclose such information, a
Party owning such Party Information (or each Party with respect to New Information) shall be
entitled to seek, by way of private litigation, injunctive relief or other equitable relief, in
addition to any and all remedies available at law or in equity, including the recovery of damages
and reasonable attorneys’ fees, and in any such action for equitable relief in a court of competent
jurisdiction, the Parties will not assert as a defense that there is an adequate remedy at law.



     16.3 Publication of New Information. During the Term, if either Company 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 Other Publications. The Parties will mutually agree upon the contents of a joint press release with respect to the
execution of this Agreement which shall be issued simultaneously by both Parties on the Effective
Date. During the Term, Company and Regeneron agree not to (and to ensure that their respective
Affiliates do not ) issue any other press releases or public announcements concerning this
Agreement or any other activities contemplated hereunder without the prior written consent of the
other Party (which shall not be unreasonably withheld or delayed), except as required by a
Governmental Authority or applicable Law (including the rules and regulations of any stock exchange
or trading market on which a Party’s (or its parent entity’s) securities are traded); provided that
the Party intending to disclose such information shall use reasonable efforts to provide the other
Party advance notice of such required disclosure, an opportunity to review and comment on such
proposed disclosure (which comments shall be considered in good faith by the disclosing Party) and
all reasonable cooperation to assist the other Party to protect such information and shall limit
the disclosure to that information which is required to be disclosed. Notwithstanding the
foregoing, without prior submission to or approval of the other Party, either Party may issue press
releases or public announcements which incorporate information concerning this Agreement or any
activities contemplated hereunder which information was included in a press release or public
disclosure which was previously disclosed under the terms of this Agreement or which contains only
non-material factual information regarding the Collaboration (e.g., that the
Collaboration is ongoing in accordance with the terms of this Agreement). Except as required by a
Governmental Authority or applicable Law (including the rules and



70









 







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
16 without the prior written consent of the other Party, which consent shall not be unreasonably
withheld or delayed; except for disclosures to Third Parties that are bound by obligations of
confidentiality and nonuse 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. Company acknowledges that Regeneron as a publicly traded company
is legally obligated to make timely disclosures of all material events relating to Licensed
Products. The Parties acknowledge that either or both Parties may be obligated to file a copy of
this Agreement with the United States Securities and Exchange Commission or its equivalent in the
Territory. Each Party will be entitled to make such filing but shall 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) Company 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 Company, 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
faith, intentional wrongful acts or omissions or violations of Law committed by
Regeneron or any other Regeneron Indemnitee; or



71









 






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



          (b) Regeneron will defend, indemnify and hold harmless Company, its Affiliates and their
respective officers, directors, employees, Sublicensees and agents (“Company
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 Company 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 Company or any other
Company Indemnitee; or




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



          (c) Subject to the last sentence of Section 19.6, 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) Company agrees to indemnify the Regeneron Indemnitees from and against all Damages
arising from product liability or other Third Party contractual claims arising from Company’s or
its Affiliates’ or Sublicensees’ Commercialization of Licensed Products in the Field in the
Territory, except that Regeneron shall indemnify Company under Section 17.1(b) for all such
claims resulting from, and to the extent allocable to, the gross negligence, recklessness, bad
faith, intentional wrongful acts or omissions or violations of Law committed by Regeneron or any
other Regeneron Indemnitee. Regeneron agrees to indemnify the Company Indemnitees from and
against all Damages arising from product liability or other Third Party contractual claims
arising from Regeneron’s or its Affiliates’ or Sublicensees’ commercialization of Regeneron
Products in the Field in the Excluded Territory, except that Company shall indemnify Regeneron
under Section 17.1(a) for all such claims resulting from, and to the extent allocable to, the
gross negligence, recklessness, bad faith, intentional wrongful acts or omissions, or violations
of Law committed by Company or any other Company Indemnitee. Company agrees to indemnify the
Regeneron Indemnitees from and against all Damages arising from product liability or other Third
Party contractual claims arising from Company’s or its Affiliates’ or Sublicensees’



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commercialization of Company Products in the Field in the Excluded Territory, except that
Regeneron shall indemnify Company under Section
17.1(b) for all such claims resulting from, and to the extent allocable to, the gross
negligence, recklessness, bad faith, intentional wrongful acts or omissions or violations of Law
committed by Regeneron or any other Regeneron Indemnitee. Damages from product liability or
other Third Party claims arising from the Development of any Licensed Product in the Field under
this Agreement for which neither Party is entitled to indemnification under this Section 17.1
shall be treated as Development Costs.



          (e) Immediately upon First Commercial Sale in the Territory, during the Term and for a
period of five (5) years after the expiration of this Agreement or the earlier termination
thereof, each Party shall use Commercially Reasonable Efforts to obtain and/or maintain (either
directly or as a named insured on a Third Party insurance policy or policies), at its sole cost
and expense, product liability insurance (including any self-insured arrangements) in amounts,
respectively, which are reasonable and customary for comparable products in the pharmaceutical
industry for companies of comparable size and activities at the respective place of business of
each Party; provided that Regeneron shall not be required to obtain or maintain such insurance in
an amount greater than [**********] per incident and in the aggregate. Such product liability
insurance or self-insured arrangements shall insure against personal injury, physical injury or
property damage arising out of, for Regeneron, Manufacture of Licensed Products (if applicable)
and sale, distribution or marketing of Regeneron Products in the Excluded Territory, and for
Company, the sale, distribution or marketing of Licensed Products in the Territory.



          (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 Company 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 8; 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 8.



     17.2 Indemnity Procedure. The Party entitled to indemnification under this Article 17 (an “Indemnified Party”)
shall notify the Party potentially responsible for such indemnification (the “Indemnifying
Party”) within five (5) Business Days of becoming aware of any claim or claims asserted or
threatened against the Indemnified Party which could give rise to a right of indemnification under
this Agreement; provided, however, that the failure to give such notice shall not relieve the
Indemnifying Party of its indemnity obligation hereunder except to the extent that such failure
materially prejudices its rights hereunder. 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).



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          (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 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 and
the Indemnified Party.



          (c) The amount of any Damages for which indemnification is provided under this Article 17
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 17
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 17 and (ii) the amount necessary to fully



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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 17.



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.



          (a) The “Term” of this Agreement shall commence on the Effective Date and, unless
this Agreement is earlier terminated as provided hereafter, shall end at 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; provided, that if at any time during the Term Company loses the exclusive legal right
to Commercialize Licensed Product in the Field in any Major Market Country, whether due to
expiration of Regeneron Patent Rights or expiration of any statutory marketing exclusivity period
for Licensed Product in such Major Market Country, the Parties shall meet to discuss and attempt
to enter into an amendment to this Agreement for the purpose of simplifying the governance
structure hereunder.



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



     19.2 Termination Without Cause. Company may terminate this Agreement with respect to the entire Territory for all Licensed
Products in the Field on [*****************] prior written notice to
Regeneron. Except as otherwise provided below in 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



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forth above (the “Termination Notice Period”) and the terms
of Schedule 7 shall apply. Except as set forth in this Section 19.2, Section 19.8 (last
paragraph), or Schedule 7, during the Termination Notice Period, the Parties shall continue to
Develop, Manufacture and Commercialize Licensed Products in the Field in accordance with Plans.
During the Termination Notice Period, to the extent set forth or requested in one or more written
notices from Regeneron to Company hereunder and in any event upon the expiration of the applicable
Termination Notice Period, whether or not any such notice is given by Regeneron, (a) the licenses
and rights granted to Company hereunder shall automatically terminate as of a date specified in
such notice(s) (and in any event not later than the expiration of the applicable Termination Notice
Period) and (b) Company will promptly take the actions required by Schedule 7 and Regeneron will
reasonably cooperate with Company (for avoidance of doubt, such cooperation shall not require
Regeneron to pay any amounts or incur any liabilities or obligations not otherwise required
hereunder to be paid or incurred by Regeneron) to facilitate Regeneron’s (or its nominee’s)
expeditious assumption during the Termination Notice Period and thereafter, with as little
disruption as reasonably possible, of the continued Development, Manufacture and Commercialization
of Licensed Products in the Field in the Territory. In addition, during the Termination Notice
Period,[**************************,] and (ii) 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 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 if the other Party commits a material breach of this
Agreement. Such notice of termination shall set forth in reasonable detail the facts underlying or
constituting the alleged breach (and specifically referencing the provisions of this Agreement
alleged to have been breached), and the termination which is the subject of such notice shall be
effective ninety (90) days after the date such notice is given unless the breaching Party shall
have cured such breach within such ninety (90) day period (or, if such material breach, by its
nature, is a curable breach but such breach is not curable within such ninety (90) day period, such
longer period not to exceed one hundred eighty (180) days so long as the breaching party is using
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 a breach by a Party that
substantially undermines the benefits reasonably expected to be realized by the non-breaching Party
from the Collaboration, taken as a whole.



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     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 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. Notwithstanding anything to the contrary herein, Regeneron will have the unilateral right to
terminate this Agreement in its entirety, effective immediately, upon written notice to Company, if
Section 20.16 of this Agreement shall have been breached. For the avoidance of doubt, Company
will not be deemed to have breached Section 20.16, and Regeneron shall not have the right to
terminate this Agreement, as a result of an inadvertent breach of Section 20.16 arising from (a)
discussion with any Third Parties that are initiated by such Third Parties, are not publicly
disclosed and do not result in any actions referred to in paragraphs (a) through (g) of Section
20.16 or (b) any informal discussions covering general corporate or other business matters the
purpose of which is not to effectuate or lead to any of the actions referred to in paragraphs (a)
through (g) of Section 20.16.



     19.6  [******************].



     19.7 Effect of Termination.



          (a) Except as set forth in Section 19.7(b) below, upon termination of this Agreement prior
to expiration of the Term (and during the applicable Termination Notice Period or 6-Month Notice
Period), the provisions of Schedule 7 shall apply, and except to the extent required by Company
to fulfill its obligations pursuant to Schedule 7, (i) all licenses and rights granted by
Regeneron to Company hereunder shall automatically terminate, and revert to Regeneron, (ii) all
licenses and rights granted by Company to Regeneron hereunder with respect to Company Products
shall automatically terminate, and revert to Company, and (iii) the licenses from Company and its
Affiliates



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to Regeneron referred to in Schedule 7 shall come into full force and effect. In
addition, upon termination of this Agreement prior to expiration of the Term (and during the
applicable Termination Notice Period or 6-Month Notice Period), the following paragraphs of
Schedule 8 shall apply with respect to any Company Products: (i) paragraph 1 of Schedule 8, (ii)
paragraph 3 of Schedule 8 and (iii) paragraph 4 of Schedule 8. If Regeneron terminates this
Agreement pursuant to Section 19.3, 19.4 or 19.5, then Company shall pay to Regeneron, in
addition to any other amount payable by Company to Regeneron under this Agreement, under Law, or
pursuant to any contractual remedies available to Regeneron, an amount equal to (i) fifty percent
(50%) of the Development Costs incurred by Regeneron under the Global Development Plan but
excluding the Aggregate Regeneron Payment Amount, and (ii) one hundred percent (100%) of the
Development Costs incurred by Regeneron under the Territory 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 Company pursuant to Section 19.3 or 19.4, the
provisions of Schedule 8 shall apply with respect to any Company Product and, except to the
extent required by Regeneron to fulfill its obligations pursuant to Schedule 8, (i) all licenses
and rights granted by Company to Regeneron hereunder with respect to Company Products shall
automatically terminate, and revert to Company, (ii) all licenses and rights granted by Regeneron
to Company hereunder with respect to Regeneron Products shall automatically terminate and revert
to Regeneron and (iii) the licenses from Regeneron and its Affiliates to Company referred to in
Schedule 8 shall come into full force and effect for the Company Products. In addition, upon
termination of this Agreement by Company pursuant to Section 19.3 or 19.4, the following
paragraphs of Schedule 7 shall apply with respect to any Regeneron Products: (i) paragraph 1 of
Schedule 7, (ii) paragraph 3 of Schedule 7 and (iii) paragraph 4 of Schedule 7.



          (c) [**************************************].



     19.8 Survival of Obligations. Except as otherwise provided in this Article 19, Schedule 7 or Schedule 8, upon expiration or
termination of this Agreement, the rights and obligations of the Parties hereunder shall terminate,
and this Agreement shall cease to be of further force or effect,
provided that notwithstanding any expiration or termination of this Agreement:



          (a) neither Company 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;



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          (b) subject to the provisions of this Article 19, including Schedule 7 and Schedule 8 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 16, as well as
other provisions (including, without limitation, Sections 6.16, 7.5, 9.7, 9.8, 9.10 and 10.3, and
Articles 12 (with respect to Joint Inventions), 16, 17, 19 and 20) 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 19 shall be without prejudice to any
rights or remedies a party may have for breach of this Agreement.



     Notwithstanding the foregoing or any other term or provision of this Agreement, (i) if Company
terminates this Agreement under Section 19.2 or Section 19.6 and, during the Termination Notice
Period or 6-Month Notice Period, as the case may be, Regeneron enters into a license agreement for
a Licensed Product in the Field in the Territory substantially similar in scope as, and providing
for the assumption and performance by the counterparty thereto of the obligations of Company under,
this Agreement, Company’s continuing obligations under the Plans pursuant to Section 19.2 or
Section 19.6, as applicable, shall expire, and (ii) upon termination of this Agreement for any
reason other than a material breach by Regeneron and consequent termination by Company under
Section 19.3, except as set forth in Section 19.7(c), Regeneron’s obligations with respect to
Global Development Balance Payments to Company provided for in Schedule 2 shall automatically
terminate and the Global Development Balance shall equal zero.



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 conflict of laws principles. Except as set forth in Article 10, 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 hereunder or in connection herewith shall be
in writing, shall be sent to the address of the relevant Party set forth on Schedule 9 attached
hereto and shall be (a) delivered personally,



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(b) sent by registered or certified mail, return
receipt requested, postage prepaid, (c) sent via a reputable nationwide overnight courier service
or (d) sent by facsimile transmission, with a confirmation copy to be sent by registered or
certified mail, return receipt requested, postage prepaid. Any such notice, instruction or
communication shall be deemed to have been delivered upon receipt if delivered by hand, three (3)
Business Days after it is sent by registered or certified mail, return receipt requested, postage
prepaid, one (1) Business Day after it is sent via a reputable nationwide overnight courier service
or when transmitted with electronic confirmation of receipt, if transmitted by facsimile (if such
transmission is made during regular business hours of the recipient on a Business Day; or
otherwise, on the next Business Day following such transmission). Either Party may change its
address by giving notice to the other Party in the manner provided above.



     20.4 Entire Agreement. This Agreement contains the complete understanding of the Parties with respect to the subject
matter hereof and thereof and supersedes all prior understandings and writings relating to the
subject matter hereof and thereof.



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



     20.6 Headings. Headings in this Agreement are for convenience of reference only and shall not be considered in
construing 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



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Company or Regeneron without (a) the prior written
consent of Regeneron in the case of any assignment by Company or (b) the prior written consent of
Company 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 Company 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. Without limiting the foregoing, each Party shall take reasonable efforts to ensure
that each of its Affiliates engaged in the development or commercialization of ophthalmic products
or technologies and which have know-how or technologies that are materially useful for the
Development or Commercialization of Licensed Products, engage in the Development or
Commercialization of Licensed Products or otherwise license their Know-How under this Agreement.
Each Party absolutely, unconditionally and irrevocably guarantees to the other Party prompt
performance when due and at all times thereafter of the responsibilities, liabilities, covenants,
warranties, agreements and undertakings of its Affiliates pursuant to this Agreement. Without
limiting the foregoing, neither Party shall cause or permit any of its Affiliates to commit any act
(including any act or omission) which such Party is prohibited hereunder from committing directly.
If an Affiliate of a Party will engage in the Development, Manufacture or Commercialization of a
Licensed Product or will otherwise license its Know-How 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.



     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



81









 







foregoing, Article 17 is intended to benefit, in addition to the Parties, the other Regeneron
Indemnitees and Company Indemnitees as if they were parties hereto, but this Agreement is
enforceable only by the Parties.



     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
Company 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 Company, and Company’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 COMPANY 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 Standstill Agreement. During the period commencing on the Effective Date and expiring on the date which is five (5)
years after the end of the Term, neither Company nor any of its Affiliates (for purposes of this
Section 20.16, Company, together with such Affiliates, being referred to as the “Investor”)
shall:



          (a) directly or indirectly, acquire beneficial ownership of Shares of Then Outstanding
Capital Stock or any securities convertible into or exchangeable for Shares of Then Outstanding
Capital Stock, or make a tender, exchange or other offer to acquire Shares of Then Outstanding
Capital Stock, if after giving effect to such acquisition (and assuming the conversion of all
convertible securities), the Investor would beneficially own (as defined in Rule 13d-3 under the
Securities Exchange Act of 1934, as amended) twenty percent (20%) or more of the Shares of Then
Outstanding Capital Stock; provided, however, that notwithstanding the provisions of this Section
20.16, if the number of shares constituting Shares of Then Outstanding Capital Stock is reduced
or if the aggregate ownership of the Investor is increased as a result of a recapitalization of
Regeneron, Investor shall not be required to dispose of any of its holdings of Shares of Then
Outstanding Capital Stock even though such action resulted



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in Investor’s ownership totaling
twenty percent (20%) or more of the Shares of Then Outstanding Capital Stock;



          (b) directly or indirectly, propose or nominate for election to the Board of Directors of
Regeneron any Person whose nomination has not been approved by a majority of the Board of
Directors of Regeneron, or vote or cause to be voted in favor of such Person for election to the
Board of Directors of Regeneron any Shares of Then Outstanding Capital Stock;



          (c) directly or indirectly, accept or support a tender, exchange or other offer or proposal
by any other Person or group (an “Offeror”) the consummation of which would result in a
Change of Control of Regeneron (an “Acquisition Proposal”);



          (d) directly or indirectly, solicit proxies or consents or become a participant in a
solicitation (as such terms are defined in Regulation 14A under the Securities Exchange Act) in
opposition to the recommendation of a majority of the Board of Directors of Regeneron with
respect to any matter, or seek to advise or influence any Person, with respect to voting of any
Shares of Then Outstanding Capital Stock of Regeneron or any of its Affiliates;



          (e) deposit any Shares of Then Outstanding Capital Stock in a voting trust or subject any
Shares of Then Outstanding Capital Stock to any arrangement or agreement with respect to the
voting of such Shares of Then Outstanding Capital Stock;



          (f) act in concert with any Third Party to take any action in clauses (a) through (e) above;



          (g) request or propose that Regeneron or any of Regeneron’s officers or its Board of
Directors amend, waive, or consider the amendment or waiver of any provisions set forth in this
Section 20.16; or



          (h) enter into discussions, negotiations, arrangements or agreements with any Person
relating to the foregoing actions referred to in clauses (a) through (g) above;


provided that the mere voting of any Shares of Then Outstanding Capital Stock held by the Company
shall not constitute a violation of any of clauses (a) through (f) above.




     20.17 Termination of Standstill. Provided Investor has not violated Section 20.16(d), (f) or (h) with respect to the Offeror
referred to in this Section 20.17, the restrictions contained in Section 20.16 shall terminate upon
the earlier to occur of (a) the public announcement by an Offeror of an Acquisition Proposal; (b)
the acquisition by an Offeror (other than Dr. Leonard Schleifer or his Affiliates) of beneficial
ownership of Shares of Then Outstanding Capital Stock, which, when combined with all other Shares
of Then Outstanding Capital Stock beneficially owned by the Offeror, represents more than
[********************] of the voting power represented by all issued and outstanding Shares of Then
Outstanding Capital Stock; (c) the issuance by Regeneron to a Third Party



83









 







(other than an
underwriter in a public offering which promptly distributes such shares to the public) of Shares of
Then Outstanding Capital Stock, which, when combined with all other Shares of Then Outstanding
Capital Stock beneficially owned by such Third Party, represents more than [*****************] of
the voting power represented by all issued and outstanding Shares of Then Outstanding Capital
Stock, if Regeneron does not enter into a standstill agreement with such Third Party for a time
period and upon terms substantially similar to the provisions of Section 20.16; (d) a sale of all
or substantially all of the assets of Regeneron (other than to a wholly owned subsidiary of
Regeneron); or (e) a liquidation or dissolution of Regeneron, which would give rise to a
termination of this Agreement pursuant to Section 19.4; provided, however, that if any of the
transactions referred to in (a), (b) or (d) above terminates and Regeneron has not made a public
announcement of its
intent to solicit or engage in a transaction referred to in Section 20.16 (or has announced its
decision to discontinue pursuing such a transaction) the consummation of which would result in a
Change of Control of Regeneron, then the restrictions contained in Section 20.16 shall again be
applicable.



     20.18 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.



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



84









 





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



	 	 	 	 	 	 	 
	 	 	BAYER HEALTHCARE LLC	 	 
	 
	 	 	 	 	 	 
	 

	 	By
	 	/s/ Jeffrey M. Greenman
	 	 
	 

	 	Name:
	 	Jeffrey M. Greenman	 	 
	 

	 	Title:
	 	General Counsel and Secretary	 	 
	 
	 	 	 	 	 	 
	 	 	REGENERON PHARMACEUTICALS, INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By
	 	/s/ Murray A. Goldberg	 	 
	 

	 	Name:
	 	Murray A. Goldberg
	 	 
	 

	 	Title:
	 	Senior Vice President, Finance & Administration

and Chief Financial Officer	 	 






85









 





SCHEDULE 1




Manufacturing Cost



“Manufacturing Cost” as used in this Agreement shall be determined as provided in this
Schedule 1.




A. General Principles




     1. Regeneron shall supply Formulated Bulk Product for Clinical Supply Requirements and
Commercial Supply Requirements at Fully Burdened Manufacturing Cost, calculated as described in
Section B below.



     2. To the extent that a Manufacturing Plan includes the use of Formulated Bulk Product or
Finished Product that was Manufactured by Regeneron prior to the Effective Date, Regeneron shall
supply such Formulated Bulk Product or Finished Product at its actual average Fully Burdened
Manufacturing Cost, calculated as described in Section B below, plus Cost of Finishing, as
described in Section C below.



     3. [**********************************]



     4. If a Manufacturing Plan calls for Regeneron to reserve its facility to Manufacture
Formulated Bulk Product, including, without limitation, purifying/processing the bulk drug
substance, and the Parties subsequently amend the Manufacturing Plan such that the facility is not
used as originally set forth therein, then Regeneron shall be reimbursed for what otherwise would
have been its Fully Burdened Manufacturing Cost as if such facility had been used for Manufacturing
as originally required in the Manufacturing Plan, except for such variable costs as are actually
avoided or mitigated; provided, however, that Regeneron shall not be reimbursed hereunder if such
amendment of the Manufacturing Plan has been agreed upon at least twelve (12) months prior to its
effective date.



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




 









 








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 Territory Profit
Split for such Quarter (as set forth in Part I), plus (b) the Regeneron Reimbursement Amount for
such Quarter (as set forth in Part II), plus or minus (c) the Global True-Up (as set forth in Part
III), minus (d) the Global Development Balance Payment (commencing in the Quarter of the First
Commercial Sale in a Major Market Country) (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 Company 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 Company in accordance with the terms set forth in Article 9. An example of the
Quarterly True-Up is shown in Part V.




I. TERRITORY PROFIT SPLIT



The “Territory Profit Split” shall mean fifty percent (50%) of Territory Profits in a
Quarter. “Territory Profits” shall mean aggregate Net Sales in the Territory in the
Quarter less the sum of aggregate COGS and aggregate Shared Promotion Expenses incurred by both
Parties in the Territory in the Quarter.



An example of a calculation of the Territory Profit Split in a Quarter would be:




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Territory
	 	 	Aggregate	 	Company	 	Regeneron	 	Profit Split
	 
	Net Sales in the Territory
	 	 	1000	 	 	 	1000	 	 	 	 	 	 	 	 	 
	 
	COGS
	 	 	(50	)	 	 	(50	)	 	 	0	 	 	 	 	 
	 
	Shared Promotion Expenses
	 	 	(350	)	 	 	(300	)	 	 	(50	)	 	 	 	 
	 
	 
	Territory Profits
	 	 	600	 	 	 	 	 	 	 	 	 	 	 	300	 






 









 





II. REGENERON REIMBURSEMENT AMOUNT



The “Regeneron Reimbursement Amount” for a Quarter shall mean (a) Shared Promotion Expenses
incurred by Regeneron in the Quarter (if any), plus (b) Commercial Supply Costs incurred by
Regeneron in the Quarter (if any), plus (c) Development Costs incurred by Regeneron under the
Territory Development Plan in the Quarter (if any).



An example of a calculation of the Regeneron Reimbursement Amount in a Quarter would be:




	 	 	 	 	 
	Regeneron Shared Promotion Expenses
	 	 	50	 
	 
	Regeneron Commercial Supply Costs
	 	 	10	 
	 
	Regeneron Development Costs under Territory Development Plan
	 	 	5	 
	 
	Regeneron Reimbursement Amount
	 	 	65	 






III. GLOBAL TRUE-UP



The “Global True-Up” for a Quarter shall mean (a) fifty percent (50%) of the sum of (i)
aggregate Development Costs incurred by both Parties under the Global Development Plan in the
Quarter and (ii) aggregate Other Shared Expenses incurred by both Parties in the Quarter, minus (b)
one hundred percent (100%) of the sum of (i) Development Costs incurred by Company under the Global
Development Plan in the Quarter and (ii) Other Shared Expenses incurred by Company during the
Quarter. If the Global True-Up is a positive number, it shall be added in the calculation of the
Quarterly True-Up and, if it is a negative number, the absolute value of such amount shall be
subtracted in the calculation of the Quarterly True-Up.



An example of a calculation of the Global True-Up in a Quarter would be:




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Global
	 	 	Aggregate	 	Company	 	Regeneron	 	True-Up
	 
	Development Costs under
Global Development Plan
	 	 	80	 	 	 	30	 	 	 	50	 	 	 	 	 
	 
	Other Shared Expenses
	 	 	40	 	 	 	35	 	 	 	5	 	 	 	 	 
	 
	 
	Total
	 	 	120	 	 	 	65	 	 	 	55	 	 	 	(5	)






2









 





IV. GLOBAL DEVELOPMENT BALANCE PAYMENT



The “Global Development Balance” for a Quarter shall mean (a) twenty-five percent (25%) of
the aggregate amount of Development Costs incurred by both Parties under the Global Development
Plan from January 1, 2007 through the close of such Quarter
[(***************************************)] plus (b) fifty percent (50%) of the aggregate amount of
Development Costs incurred by both Parties under the Territory Development Plan from the Effective
Date through the close of such Quarter [(******************************************)] less (c) the
aggregate amount of Global Development Balance Payments included in the calculation of the
Quarterly True-Up in all prior Quarters.



The “Global Development Balance Payment” shall mean,
[*****************************************]



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




	 	 	 	 	 
	Territory Profit Split
	 	 	300	 
	 
	 	 	 	 
	Global Development Balance
	 	 	200	 
	[***********************]
	 	 	[****]	 
	 
	 	 	 	 
	Global Development Balance Payment
	 	 	[***]	 






3









 





V. EXAMPLE OF QUARTERLY TRUE-UP



An example of a calculation of the Quarterly True-up in a Quarter would be:




	 	 	 	 	 
	Territory Profit Split
	 	 	300	 
	Regeneron Reimbursement Amount
	 	 	65	 
	Global True-Up
	 	 	(5	)
	Global Development Balance Payment
	 	 	[****]	 
	 
	Quarterly True-up
	 	 	[***]	 





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



A more detailed illustration of the calculations under this Schedule 2 will be prepared by the JFC
promptly after the Effective Date.




4









 





SCHEDULE 3




Milestone Payments




I. DEVELOPMENT MILESTONES



The following non-refundable, non-creditable milestone payments shall be payable by Company to
Regeneron upon the achievement of each applicable milestone event set forth below for each
Regeneron Product in each Major Indication (but in no event more than two (2) Major Indications per
Milestone Event). The term “Major Indication” shall include (i) the neovascular form of
age-related macular degeneration, (ii) diabetic macular edema, [********************************].
If an indication in the Field that is not initially considered by the Parties to be a Major
Indication later is determined to be a Major Indication, then within thirty (30) days of such
determination, Company shall pay to Regeneron any milestone payments for previous Milestone Events
(as set forth below) that occurred with respect to the Development of any Regeneron Product(s) in
such indication in the Territory.




	 	 	 	 	 
	Milestone	 	Payment	 	Milestone Event
	 
	1.

	 	US $20,000,000
	 	For each Regeneron Product, upon
administration of the Regeneron Product to
the first patient in the first Phase 3 Trial
for any Major Indication identified in a
Development Plan
	2.

	 	[**********]
	 	[*******************]
	3.

	 	[***********]
	 	[******************]
	4.

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





For clarity and by way of example only, [******************************]




II. SALES MILESTONES



In addition to all other amounts payable under this Agreement, Company shall make the following
additional non-refundable, non-creditable milestone payments to Regeneron based on the aggregate
Net Sales in any twelve (12) consecutive month time period (“Twelve Month Period”):




	 	 	 	 	 
	Milestone	 	Payment	 	Milestone Event
	 
	1.

	 	[***************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

 or exceed US $200,000,000
	2.

	 	[***************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

 or exceed [**********]






 









 






	 	 	 	 	 
	Milestone	 	Payment	 	Milestone Event
	 
	3.

	 	[***************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

 or exceed [************]
	4.

	 	[***************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

 or exceed [***********]
	5.

	 	[***************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

 or exceed [***********]
	6.

	 	[**************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

or exceed [************]
	7.

	 	[**************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

or exceed [************]
	8.

	 	[**************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

or exceed [***********]
	9.

	 	[**************]
	 	First Twelve Month Period in which

aggregate Net Sales in such period equal

or exceed [***********]





For clarity, “aggregate Net Sales” means the total of Net Sales of all Licensed Products in the
Field in the Territory. For further clarity, one or more of the milestone payments set forth in
this Section II of Schedule 3 may become payable based on the same milestone event. For example,
[***********************************].



For purposes of further clarification, each separate milestone in this Section II of Schedule 3 may
be achieved only once and the milestone numbers are included for reference purposes only.



For purposes of this Schedule 3, Net Sales will be converted to United States Dollars using the
currency conversion procedure described in Section 9.6.





2









 








SCHEDULE 4




Existing Licenses




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




 









 





SCHEDULE 5




Initial Development Plan




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




 









 





SCHEDULE 6




Regeneron Patent Rights




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




 









 





SCHEDULE 7




Termination Arrangements




     1. Company 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 of Regeneron and its Affiliates, and shall immediately cease, and
cause its Affiliates and Sublicensees to cease, all further use of any New Information and Party
Information of Regeneron and its Affiliates. In addition, at Regeneron’s request, Company shall
collect and transfer to Regeneron any remaining inventory of Regeneron Product Promotional
Materials, Regeneron Product sales training materials, Regeneron Product samples, and Regeneron
Product inventory. Notwithstanding the foregoing, Company may retain copies of any 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,
non-exclusive right and license, with the right to sublicense unless otherwise restricted by any
Existing License or New License, under the Company Excluded Territory Intellectual Property
existing at the effective date of termination to Develop, Manufacture and Commercialize Regeneron
Products in the Field.



     3. Company 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 Regeneron Products in the Field. 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) Company 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 Company or its Affiliates or any of its Sublicensees to the extent specifically relating to
Regeneron Products.




          (b) Company shall assign and transfer to Regeneron (or its nominee) Company’s entire right,
title and interest in and to all Product Trademarks and Promotional Materials relating to Regeneron
Products; provided that nothing herein is intended to convey any rights in or to Company’s
corporate name and logos or any trade names except for the limited rights set forth herein.




          (c) Company 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 Regeneron Products 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 any Regeneron Products in the Field,
including, without limitation, all information contained in the regulatory and/or safety databases,
all in the format then currently maintained by Company, or such other format as may be reasonably
requested by Regeneron.




          (d) Company shall use Commercially Reasonable Efforts to assign to Regeneron any applicable
sublicenses to the extent related to any Regeneron Product and/or contracts relating to significant
services to be performed by Third Parties to the extent related to Development, Manufacture or
Commercialization of any Regeneron Product in the Field in the Territory, as reasonably requested
by Regeneron and subject to the German Employee Invention Act.




          (e) Without limitation of Company’s other obligations under this Schedule 7, to the extent
Company or its Affiliate is Manufacturing (in whole or in part) Regeneron Products for use in the
Field in accordance with a Manufacturing Plan (or is designated to assume such responsibilities),
Company (or its Affiliate) will perform such Manufacturing responsibilities and supply Regeneron
with Clinical Supply Requirements and/or Commercial Supply Requirements of Regeneron Products, and
Regeneron shall purchase such Regeneron Products, at the same price, and on such other terms and
conditions on which Company was supplying, or in the absence of termination would have been
required to supply, such Regeneron Products, through the second anniversary of the effective date
of termination of this Agreement or such shorter period if Regeneron notifies Company that
Regeneron is able to Manufacture or have Manufactured Regeneron Products 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 Regeneron Products 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, Regeneron shall not be required to provide Company any
consideration in exchange for the licenses or other rights granted to it pursuant to the provisions
of this Schedule 7; provided, however, that Regeneron shall be solely responsible for paying any
royalties, fees or other consideration that Company 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.



 









 





SCHEDULE 8




Termination Arrangements




     1. Regeneron shall promptly collect and return, and cause its Affiliates and sublicensees to
collect and return, to Company or, at Company’s request, destroy, all documents containing New
Information or Party Information of Company and its Affiliates, and shall immediately cease, and
cause its Affiliates and sublicensees to cease, all further use of any New Information related to
the Development, Manufacture and Commercialization of Company Products and any Party Information of
Company and its Affiliates. In addition, at Company’s request, Regeneron shall collect and
transfer to Company any remaining inventory of Company Product Promotional Materials, Company
Product sales training materials, Company Product samples and Company Product inventory.
Notwithstanding the foregoing, Regeneron may retain copies of any New Information to the extent
required by Law, as well as retain one (1) copy of such information solely for legal archive
purposes.



     2. Company and its Affiliates shall have a worldwide, fully paid-up, royalty-free,
non-exclusive right and license, with the right to sublicense unless otherwise restricted by any
Existing License or New License, under the Regeneron Excluded Territory Intellectual Property
existing at the effective date of termination to Develop, Manufacture and Commercialize Company
Products in the Field.



     3. Regeneron shall use Commercially Reasonable Efforts to provide all cooperation and
assistance reasonably requested by Company to enable Company (or its nominee) to assume with as
little disruption as reasonably possible, the continued Development, Manufacture and
Commercialization of the Company Products in the Field. 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 Company (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
Company Products.




          (b) Regeneron shall assign and transfer to Company (or its nominee) Regeneron’s entire right,
title and interest in and to all Product Trademarks for Company Products and Promotional Materials
relating to Company Products; 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 Company (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 Company Products) of all




 









 







information (including any New Information) in its possession or under its control to the
extent directly relating to any Company Products 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 Company.




          (d) Regeneron shall use Commercially Reasonable Efforts to assign to Company any applicable
sublicenses to the extent related to any Company Product and/or contracts relating to significant
services to be performed by Third Parties to the extent related to Development, Manufacture or
Commercialization of any Company Product in the Field, as reasonably requested by Company, and
subject to the German Employee Invention Act.




          (e) Without limitation of Regeneron’s other obligations under this Schedule 8, to the extent
Regeneron or its Affiliate is Manufacturing (in whole or in part) Company Products 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 Company
with Clinical Supply Requirements and/or Commercial Requirements of Company Products, and Company
shall purchase such Company Products, 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 Company Products, through the second anniversary of the effective date of termination of this
Agreement or such shorter period if Company notifies Regeneron that Company is able to Manufacture
or have Manufactured Company Products 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 Company Products in the Field hereunder to Company (or its Sublicensee or Third Party
designee) as soon as is reasonably possible.



     5. For the avoidance of doubt, Company 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 8; provided, however, that Company 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 Company of such licenses or other rights.



 









 





SCHEDULE 9




Notices




	 	 	 
	(a)

	 	If to Company:
	 

	 	Bayer HealthCare LLC
	 

	 	511 Benedict Avenue
	 

	 	Tarrytown, New York 10591
	 

	 	U.S.A.
	 
	 	 
	 

	 	With copy to:
	 
	 	 
	 

	 	Bayer HealthCare AG
	 

	 	51368 Leverkusen, Germany
	 

	 	Attention: General Counsel
	 
	 	 
	 

	 	And a copy to:
	 
	 	 
	 

	 	Bayer Pharmaceuticals Corporation
	 

	 	400 Morgan Lane
	 

	 	West Haven, Connecticut 06516
	 

	 	U.S.A.
	 

	 	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