Document:

A/R 364-DAY CREDIT AGREEMENT

 

EXHIBIT 10.3

CONFORMED COPY

AMENDED AND RESTATED CREDIT AGREEMENT

     AMENDED AND RESTATED CREDIT AGREEMENT dated as of
September 8, 2003 amending and restating the Amended and
Restated Credit
Agreement dated as of September 9, 2002 (as in effect prior
to the amendment and
restatement of September 8, 2003, the “Credit Agreement”)
among MOODY’S
CORPORATION (the “Company”), the Borrowing Subsidiaries
party thereto
(the “Borrowing Subsidiaries” and together with the
Company, the
“Borrowers”), the LENDERS party thereto (the “Lenders”),
JPMORGAN
CHASE BANK (as successor to The Chase Manhattan Bank), as
Administrative
Agent (the “Administrative Agent”), CITIBANK, N.A., as
Syndication Agent,
and THE BANK OF NEW YORK, as Documentation Agent.

WITNESSETH:

     WHEREAS, the parties hereto desire to amend the Credit
Agreement to (i)
extend the Revolver Termination Date from the date that is
364 days after the
effective date of the Credit Agreement to the date that is
364 days after the
Amendment Effective Date (as hereinafter defined), (ii)
make any necessary
conforming changes with respect to the amendment set forth
in clause (i) above,
(iii) amend the Confidentiality provisions in Section 10.12
of the Credit
Agreement and (iv) amend the Commitments of each Lender,
all as set forth
herein;

     WHEREAS, the parties hereto wish to amend the Credit
Agreement as set
forth herein and to restate the Credit Agreement in its
entirety to read as set forth
in the Credit Agreement with the amendments specified
below;

     NOW, THEREFORE, the parties hereto agree as follows:

     SECTION 1. Defined Terms; References. Unless otherwise
specifically
defined herein, each term used herein which is defined in
the Credit Agreement
has the meaning assigned to such term in the Credit
Agreement. Each reference to
“hereof, “hereunder”, “herein” and “hereby” and each other
similar reference and
each reference to “this Agreement” and each other similar
reference contained in
the Credit Agreement shall, after the Amendment Effective
Date (as defined
below), refer to the Credit Agreement as amended and
restated hereby.

     SECTION 2. Definitions. The definition of “Revolver
Termination Date” in
Section 1.01 of the Credit Agreement is amended to read
in full as follows:

 

 

         “Revolver Termination Date” means September 6, 2004 or, if
such
day is not a Business Day, the next preceding Business
Day.

     SECTION 3. Representation regarding Financial Condition
and No
Material Adverse Change. Sections 3.04(a) and (b) of the
Credit Agreement are
amended by replacing each reference therein to (i) “2000”
with “2001”, (ii)
“2001” with “2002” and (iii) “2002” with “2003”.

     SECTION 4. Confidentiality. Section 10.12 of the Credit
Agreement is
amended by adding the following new paragraph immediately
after the existing
paragraph:

     “Notwithstanding anything contrary herein or in any
related document,
each party hereto and each of its employees,
representatives, or other agents may
disclose to any and all Persons, without limitation of any
kind, the U.S. federal
income tax treatment and the U.S. federal income tax
structure of this Agreement
and the transactions contemplated hereby and all materials
of any kind, including
opinions or other tax analyses, that have been provided to
it relating to such tax
treatment and tax structure.”

     SECTION 5. Changes in Commitments. With effect from and
including the
Amendment Effective Date (as defined in Section 9 below),
(i) each Person listed
on the signature pages hereof which is not a party to the
Credit Agreement (each,
a “New Lender”) shall become a Lender party to the Credit
Agreement and (ii)
the Commitment of each Lender shall be the amount set
forth opposite the name
of such Lender on the signature pages hereof. On the
Amendment Effective Date,
any Lender whose Commitment is changed to zero (each, an
“Exiting Lender”)
shall cease to be a Lender party to the Credit Agreement,
and all accrued fees and
other amounts payable under the Credit Agreement for the
account of each Exiting
Lender shall be due and payable on such date; provided
that the provisions of
Sections 2.14, 2.16 and 10.03 of the Credit Agreement
shall continue to inure to
the benefit of each Exiting Lender after the Amendment
Effective Date.

     SECTION 6. Representations of Borrower. The Borrower
represents and
warrants that (i) the representations and warranties of
the Borrower set forth in
Article 3 of the Credit Agreement, after giving effect to
this Amendment and
Restatement, is true on and as of the Amendment Effective
Date and (ii) no
Default has occurred and is continuing on such date.

     SECTION 7. Governing Law. This Amendment and Restatement
shall be
governed by and construed in accordance with the laws of
the State of New York.

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     SECTION 8. Counterparts. This Amendment and Restatement
may be
signed in any number of counterparts, each of which shall
be an original, with the
same effect as if the signatures thereto and hereto were
upon the same instrument.

     SECTION 9. Effectiveness. This Amendment and Restatement
shall
become effective on the date when the following conditions
are met (the
“Amendment Effective Date”):

		
	 	     (a) the Administrative Agent shall have received from
each of
the Borrowers and the Lenders a counterpart hereof
signed by such party
or facsimile or other written confirmation (in form
satisfactory to the
Administrative Agent) that such party has signed a
counterpart hereof;
	 
	 	     (b) the Administrative Agent shall have received an
opinion of
Simpson Thacher & Bartlett LLP, counsel for the
Company, dated the
Amendment Effective Date (in form and substance
reasonably satisfactory
to the Administrative Agent); and
	 
	 	     (c) all fees and other amounts due and payable on or
prior to the
Amendment Effective Date, including, to the extent
invoiced,
reimbursement or payment of all reasonable
out-of-pocket expenses
required to be reimbursed or paid by the Company
hereunder.

     SECTION 10. Confirmation of Agreement. Except as amended
hereby, all
of the terms of the Credit Agreement shall remain in full
force and effect and are
hereby confirmed in all respects.

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     IN WITNESS WHEREOF, the parties hereto have caused this
Amendment and Restatement to be duly executed as of the
date first above
written.

	 	 	 	 	 
	 	 	MOODY’S CORPORATION
	 	 	 	 	 
	 	 	
By:
	 	-s- Randolph A. Roy
	 	 	 	 	

	 	 	 	 	Name: Randolph A. Roy
	 	 	 	 	Title: Vice President & Treasurer

 

 

Commitment

	 	 	 	 	 
	$17,500,000	 	JPMORGAN CHASE BANK,

individually and as Administrative Agent
	 	 	 	 	 
	 	 	
By:
	 	-s- Eileen Higgins
	 	 	 	 	

	 	 	 	 	Name: Eileen Higgins

Title: Vice President

 

 

	 	 	 	 	 
	$15,000,000	 	CITIBANK, N.A., individually and as Syndication Agent
	 	 	 	 	 
	 	 	
By:
	 	-s- James R. Stave
	 	 	 	 	

	 	 	 	 	Name: James R. Stave

Title: Vice President

 

 

	 	 	 	 	 
	$15,000,000	 	THE BANK OF NEW YORK, 

individually and as Documentation Agent
	 	 	 	 	 
	 	 	
By:
	 	-s- Ernest Fung
	 	 	 	 	

	 	 	 	 	Name: Ernest Fung

Title: Vice President

 

 

	 	 	 	 	 
	$10,000,000	 	BARCLAYS BANK PLC
	 	 	 	 	 
	 	 	
By:
	 	-s- Nicholas Bell
	 	 	 	 	

	 	 	 	 	Name: Nicholas Bell

Title: Director

 

 

	 	 	 	 	 
	$12,500,000	 	SUNTRUST BANK
	 	 	 	 	 
	 	 	
By:
	 	-s- Laura Kahn
	 	 	 	 	

	 	 	 	 	Name: Laura Kahn

Title: Director

 

 

	 	 	 	 	 
	$10,000,000	 	THE NORTHERN TRUST COMPANY
	 	 	 	 	 
	 	 	
By:
	 	-s- Eric Dybing
	 	 	 	 	

	 	 	 	 	Name: Eric Dybing

Title: Second Vice PresidentCOLLABORATION AGREEMENT

 

Exhibit 10.26

COLLABORATION AGREEMENT

By and Between

AVENTIS PHARMACEUTICALS INC.

and

REGENERON PHARMACEUTICALS, INC.

Dated as of September 5, 2003

 

 

COLLABORATION AGREEMENT

     THIS COLLABORATION AGREEMENT (“Agreement”), dated as of September 5, 2003
(the “Effective Date”), is by and between AVENTIS PHARMACEUTICALS INC., a
corporation organized under the laws of Delaware and having a principal place
of business at 200 Crossing Boulevard, Bridgewater, New Jersey 08807
(“Aventis”), and REGENERON PHARMACEUTICALS, INC., a corporation organized under
the laws of New York and having a principal place of business at 777 Old Saw
Mill River Road, Tarrytown, New York 10591 (“Regeneron”) (with each of Aventis
and Regeneron referred to herein individually as a “Party” and collectively as
the “Parties”).

     WHEREAS, Regeneron has developed certain VEGF inhibitor molecules that are
in clinical and pre-clinical trials referred to herein as VEGF Trap Products,
and Regeneron intends to Develop and Commercialize VEGF Trap Products in the
Territory;

     WHEREAS, Aventis and its Affiliates possess expertise in Developing,
manufacturing and Commercializing pharmaceutical products and have in place
large and experienced teams to conduct these activities; and

     WHEREAS, Regeneron and Aventis desire to collaborate on the Development
and Commercialization of all VEGF Trap Products and other VEGF Products in the
Territory as set forth herein (the “Collaboration”).

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

ARTICLE 1

DEFINITIONS

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

     1.1 “Acquisition Proposal” shall have the meaning set forth in Section
20.16(c).

     1.2 “Additional Major Market Country” shall mean any country in the
Territory, other than the Major Market Countries referred to in clause (i) of
the definition thereof and the Co-Marketing Countries, in which Net Sales in
the immediately prior Contract Year were [*****************] or more of
aggregate Net Sales in the Territory (excluding Co-Marketing Countries) and
such designation shall remain effective from and after the determination of
such Net Sales amount; provided, however, that a country shall not be deemed an
Additional
Major Market Country if, at the time that Net Sales in such country in a
given Contract Year first exceed [***********] of

 

 

aggregate Net Sales in the
Territory (excluding Co-Marketing Countries), the Parties mutually agree.

     1.3 “Adverse Reaction Reports” shall mean an adverse event or adverse drug
reaction as defined (i) in the ICH E2A document, (ii) in any clinical safety
reports, as referenced in 21 C.F.R. 312.32 (as may be amended from time to
time), or (iii) any international equivalent definitions used by Regulatory
Authorities in the Territory. The definition will be considered updated as
these documents are officially amended by the ICH and applicable Regulatory
Authorities to ensure compliance with regulatory reporting requirements.

     1.4 “Affiliate” shall mean, with respect to any Person, any other Person
which controls, is controlled by or is under common control with such Person.
A Person shall be deemed to control another Person if such Person possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such Person, whether through the ownership of voting
securities, by contract or otherwise. Without limiting the generality of the
foregoing, a Person shall be deemed to control another Person if any of the
following conditions is met: (a) in the case of corporate entities, direct or
indirect ownership of at least fifty percent (50%) of the stock or shares
having the right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with the power to direct the management and
policies of such non-corporate entities. The Parties acknowledge that in the
case of certain entities organized under the laws of certain countries outside
of the United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in such case
such lower percentage shall be substituted in the preceding sentence, provided
that such foreign investor has the power to direct the management and policies
of such entity. For purposes of this Agreement, in no event shall Aventis or
any of its Affiliates be deemed Affiliates of Regeneron or any of its
Affiliates nor shall Regeneron or any of its Affiliates be deemed Affiliates of
Aventis or any of its Affiliates.

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

     1.6 “Alliance Manager” shall have the meaning set forth in Section 3.11.

     1.7 “Alternative Supplier” shall have the meaning set forth in Section
8.5.

     1.8 “Ancillary Agreement” shall mean each other agreement referred to
herein entered into or to be entered into between the Parties to the extent
expressly identified herein as an Ancillary Agreement.

     1.9 “Anticipated First Commercial Sale” shall mean, with respect to a VEGF
Product, the date agreed upon by the Parties in advance as the expected date of
First Commercial Sale of such VEGF Product in any Therapeutic Area in a
country.

     1.10 “Approval” shall mean, with respect to each VEGF Product, any
approval (including Pricing Approvals), registration, license or authorization
from any Regulatory

2

 

Authority required for the testing, manufacture,
Development, Commercialization, sale, storage or transport of, or expanded
labeling for, such VEGF Product in any country, and shall include, without
limitation, an approval, registration, license or authorization granted in
connection with any Registration Filing.

     1.11 “Aventis” shall have the meaning set forth in the introductory
paragraph.

     1.12 “Aventis Indemnitees” shall have the meaning set forth in Section
17.1(b).

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

     1.14 “Aventis Patent Rights” shall mean those Patent Rights which are now
or hereafter during the Term owned by, licensed to, or otherwise held by
Aventis or any of its Affiliates (other than pursuant to this Agreement) with
the right to license or sublicense the same and which include at least one
claim which would be infringed by the manufacture, use, sale, offer for sale or
import of any VEGF Product.

     1.15 “Aventis Sole Inventions” shall have the meaning set forth in Section
12.1(a).

     1.16 “Aventis Trademarks” shall have the meaning set forth in Section
11.3.

     1.17 “Aventis VEGF Products” shall mean all VEGF Products which are now or
hereafter during the Term owned by, licensed to, or otherwise held by, Aventis
or any of its Affiliates (other than pursuant to this Agreement) with the right
to license or sublicense the same.

     1.18 [********************************]

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

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

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

     1.21 “Change of Control” shall mean, with respect to Regeneron, any of the
following events: (i) any Person is or becomes the “beneficial owner” (as such
term is used in Sections 12(d) and 13(d) of the Securities Exchange Act of
1934, as amended, 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 which 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; (ii) Regeneron
consolidates

3

 

with or merges into another corporation or entity, or any
corporation or entity consolidates with or merges into Regeneron, other than
(A) 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 (B) a 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 (iii) Regeneron conveys, transfers or leases
all or substantially all of its assets to any Person other than a wholly-owned
Affiliate of such Person.

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

     1.23 “Clinical Supply Cost” shall mean (i) the Manufacturing Cost of
Clinical Supply Requirements, as set forth in Schedule 1.101, and (ii) the
Out-of-Pocket Cost for purchasing, or Manufacturing Cost to manufacture, as the
case may be, comparator agent or placebo requirements.

     1.24 “Clinical Supply Requirements” shall mean, with respect to a VEGF
Product, the quantities of such VEGF Product which are required by a Party or
the Parties (i) for Development, including the conduct of pre-clinical studies
and Clinical Trials in connection with a Co-Development Plan in order to obtain
Approval of such VEGF Product in any country in the Territory and quantities of
such VEGF Product which are required by a Party for submission to a Regulatory
Authority in connection with any Registration Filing or Approval in any country
in the Territory or (ii) for any Non-Approval Trial.

     1.25 “Clinical Trial” shall mean any clinical trial conducted for the
purpose of or which results in obtaining data to support or be included in a
Registration Filing, including any clinical trial conducted or sponsored by a
Party’s medical affairs department which is referenced in a BLA solely in
connection with an integrated safety database and
[*****************************].

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

     1.27 “Co-Commercialization Country” shall mean each Co-Promotion Country
in which Regeneron has elected to Co-Promote and each Major Market Country
irrespective of whether Regeneron has elected to Co-Promote in such Major
Market Country.

4

 

     1.28 “Co-Development” shall mean the joint Development of VEGF Products by
the Parties, as described herein, and “Co-Develop” shall have a corresponding
meaning.

     1.29 “Co-Development Budget” shall mean the annual budget(s) approved by
the Joint Steering Committee included in the Co-Development Plan or the Initial
Co-Development Plan.

     1.30 “Co-Development Plan”
shall mean the annual Co-Development plan for the VEGF Products approved
by the Joint Steering Committee, including the related Co-Development Budget.

     1.31 “COGS” or “Cost of Goods Sold” shall mean the Manufacturing Cost of
VEGF Products sold in the Major Market Countries as set forth in Schedule
1.101.

     1.32 “Collaboration” shall have the meaning set forth in the recitals.

     1.33 “Collaboration Purpose” shall have the meaning set forth in Section
3.1(b).

     1.34 “Co-Market” or “Co-Marketing” shall mean the separate marketing and
sale in a Co-Marketing Country of VEGF Products under separate and distinct
trademarks.

     1.35 “Co-Marketing Country” shall mean with respect to each VEGF Product,
each country in the Territory in which Co-Promotion is not permitted under
local Law for such VEGF Product, but in which Co-Marketing is permitted under
local Law for such VEGF Product and where Regeneron has elected to Co-Market
such VEGF Product in such country.

     1.36 “Commercial Supply Requirements” shall mean, with respect to each
VEGF Product, quantities of such VEGF Product as are required by a Party or
the Parties to fulfill such Party’s or Parties’ requirements for commercial
sales and product sampling with respect to such VEGF Product in the Territory
or any country in the Territory, as the case may be.

     1.37 “Commercialize” or “Commercialization” shall mean any and all
activities directed to marketing (including activities the costs and expenses
of which constitute Pre-Launch Marketing Expenses), promoting, detailing,
distributing, importing, commercializing, offering for sale, having sold and/or
selling a VEGF Product, including sampling and conducting Non-Approval Trials.

     1.38 “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

5

 

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

     1.39 “Committee” means any of the JSC, JDC or JCC, each as defined in this
Article 1 and described in Article 3 (together with any Joint Sub-Committee or
other committee contemplated hereby or established in accordance with this
Agreement or any Ancillary Agreement).

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

     1.41 “Consolidated Net Profit/Loss Report” shall mean a consolidated
quarterly report prepared by Aventis setting forth in reasonable detail (a) Net
Sales for each Major Market Country, COGS and Shared Promotion Expenses
incurred by each Party, and the Major Market Profit Split for such quarter,
calculated in accordance with Schedule 1, (b) [************], (c) Net Sales for
each Rest of World Country and the Rest of World Profit Split for such quarter,
calculated in accordance with Schedule 1, (d) with respect to each Rest of
World Country that is also a Co-Commercialization Country, Regeneron’s Sales
Force Cost and Regeneron’s Medical Affairs Cost for such quarter, (e)
Development Costs incurred by Regeneron and Development Costs incurred by
Aventis for such calendar quarter, identified separately, and (f) the Quarterly
True-Up owed by a Party to the other Party, and the component items and
calculations in determining such Quarterly True-Up, calculated in accordance
with Schedule 1.

     1.42 “Contract Sales Force” shall mean the services of sales
representatives employed by a Third Party.

     1.43 “Contract Year” shall mean the period beginning on the Effective Date
and ending on December 31, 2003, and each succeeding twelve (12) month period
thereafter during the Term.

     1.44 “Controlling Party” shall mean Regeneron with respect to the filing,
prosecution and maintenance of a Joint Patent Right that primarily claims a
Regeneron VEGF Product (or the making or use thereof), and Aventis in the case
of all other Joint Patent Rights.

6

 

     1.45 “Co-Promote” or “Co-Promotion” shall mean the joint marketing and
promotion of VEGF Products by the Parties (or their respective Affiliates)
under the same trademark in a Co-Commercialization Country pursuant to the
applicable Country Co-Commercialization Plan.

     1.46 “Co-Promotion Country” shall mean any country included in the
Territory other than countries where Co-Promotion is not permitted by Law.

     1.47 “Country Co-Commercialization Budget” shall mean the annual budget(s)
included in a Country Co-Commercialization Plan for a particular
Co-Commercialization Country.

     1.48 “Country Co-Commercialization Plan” shall mean the plan(s), including
the related Country Co-Commercialization Budget, developed by the applicable
Joint Country Commercialization Sub-Committee for each VEGF Product in a
particular Co-Commercialization Country.

     1.49 “Country Co-Commercialization Report” shall mean a written report
summarizing the marketing and promotional activities undertaken by a Party (or
its relevant local Affiliates) during the previous quarter in connection with
the applicable Country Co-Commercialization Plan, together with a detailed
project-level statement of Shared Promotion Expenses incurred by such Party
during such quarter in such Co-Commercialization Country, including any
necessary adjustments for previous quarters.

     1.50 “CPI” shall mean the U.S. Department of Labor’s Consumer Price Index
for All Urban Consumers or, for Major Market Countries outside the U.S., such
other local inflation measure or rate agreed upon by the Parties.

     1.51 “Damages” shall have the meaning set forth in Section 17.1(a).

     1.52 “Default Interest Rate”
shall have the meaning set forth in Section 9.8.

     1.53 “Develop” or “Development” shall mean (a) activities directly and
specifically relating to the pre-clinical and clinical drug development of a
VEGF Product, including, without limitation, test method development and
stability testing, assay development, toxicology, formulation, quality
assurance/quality control development, technology transfer, statistical
analysis, process development, pharmacokinetic studies, Clinical Trials
(including research to design Clinical Trials and develop target product
profiles), regulatory affairs, drug safety surveillance activities, and
Approvals, (b) any other research and development activities with respect to a
VEGF Product and (c) any pre-launch marketing activities (including, without
limitation, market research and analysis, and health economics) performed prior
to First Commercial Sale of such VEGF Product, except for activities the costs
and expenses of which constitute Pre-Launch Marketing Expenses.

     1.54 “Development Balance” shall have the meaning set forth in Schedule 1.

7

 

     1.55 “Development Costs” shall mean, for all Development activities,
including Clinical Trials, performed after the Effective Date in accordance
with the Co-Development Plan:

          (a) all Out-of-Pocket Costs;

          (b) the Development FTE Costs of such Clinical Trials or Development
activities;

          (c) the Clinical Supply Costs;

          (d) the costs and expenses incurred in connection with formulation
development, manufacturing process development, manufacturing scale-up,
start-up, and validation, stability testing and quality assurance/quality
control development (in each case, to the extent not included in COGS); and

          (e) any other costs or expenses specifically identified and included in
the applicable Co-Development Budget.

     For clarity, it is the intent of the Parties that costs included in the
foregoing will not be unfairly allocated to the VEGF Products (to the extent
that any Development Cost is attributable, in part, to products or activities
other than the VEGF Products).

     1.56 “Development FTE Cost” shall mean, for all Clinical Trials or
Development activities performed in accordance with the Co-Development Plan,
including regulatory activities, the product of
(a) the number of FTEs required for such Clinical Trial or activity as set
forth in the approved Co-Development Plan and Co-Development Budget and (b) the
Development FTE Rate.

     1.57 “Development FTE Rate” shall mean [**********] in Contract Year 2003,
such amount to be adjusted as of January 1, 2004 and annually thereafter by the
percentage increase or decrease, if any, in the CPI since the Effective Date or
the latest adjustment hereunder, whichever is later.

     1.58 “Development Payment” shall have the meaning set forth in Schedule 1.

     1.59 “Distributor” shall mean any Third Party contractually engaged by a
Party to distribute the VEGF Products in a Rest of World Country.

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

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

     1.62 “Executive Officers” shall mean the Chief Executive Officer of
Regeneron and the Chief Executive Officer or Chief Operating Officer of
Aventis.

8

 

     1.63 “Existing Facility” shall mean, [********************].

     1.64 “Existing Licenses” shall mean the agreements listed in Part A of
Schedule 3.

     1.65 “Expert Panel” shall have the meaning set forth in Section 10.4.

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

     1.67 “Finished VEGF Product” shall mean VEGF Product in its finished,
labeled and packaged form, ready for sale to the market.

     1.68 “First Commercial Sale” shall mean the first sale of any VEGF
Product, following receipt of Marketing Approval, by a Party or one of its
Affiliates, sublicensees or Distributors to a Third Party in the relevant
country in the Territory, as the case may be, on arm’s length commercial terms.
Sales for test marketing, Clinical Trial or Non-Approval Trial purposes or
compassionate or similar use shall not be considered to constitute a First
Commercial Sale.

     1.69 “Force Majeure” shall have the meaning set forth in Article 18.

     1.70 “Formulated Bulk VEGF Product” shall mean the VEGF Products
formulated into solution, ready for storage or shipment to a manufacturing
facility, to allow processing into the final dosage form.

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

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

     1.73 “Global Co-Commercialization Budget” shall mean the annual budget(s)
included in a Global Co-Commercialization Plan.

     1.74 “Global Co-Commercialization Plan” shall mean the plan, including the
related Global Co-Commercialization Budget, prepared by the JCC and approved by
the JSC for each VEGF Product covering the Commercialization activities to be
performed centrally.

     1.75 “Global Marketing Guidelines” shall have the meaning set forth in
Section 3.3(a).

     1.76 “Good Practices” shall mean compliance with the applicable standards
contained in then-current “Good Laboratory Practices,” “Good Manufacturing
Practices”

9

 

and/or “Good Clinical Practices,” as promulgated by the FDA and all
analogous guidelines promulgated by the EMEA or the ICH, as applicable.

     1.77 “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.

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

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

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

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

     1.82 “Initial Co-Development Plan” shall have the meaning set forth in
Section 5.2.

     1.83 “Investor” shall have the meaning set forth in Section 20.16.

     1.84 “IPSC” shall have the meaning set forth in Section 3.3(h).

     1.85 “Joint Commercialization Committee” or “JCC” shall mean the Joint
Commercialization Committee described in Section 3.6(a).

     1.86 “Joint Country Commercialization Sub-Committee” shall mean a Joint
Country Commercialization Sub-Committee described in Section 3.8(a).

     1.87 “Joint Development Committee” or “JDC” shall mean the Joint
Development Committee described in Section 3.4(a).

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

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

     1.90 “Joint Steering Committee” or “JSC” shall mean the Joint Steering
Committee, as described in Section 3.2(a).

     1.91 “Joint Sub-Committees” shall mean, collectively, the Joint Country
Commercialization Sub-Committees, the Supply Chain Sub-Committee, the IPSC, the

10

 

Finance Sub-Committee, a Joint Technical Transfer Committee and such other
subcommittees as the JSC, the JCC or the JDC shall establish.

     1.92 “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 are now or hereafter during the term of this Agreement owned
by, licensed to or otherwise held by a Party or its Affiliates with the rights
to license or sublicense the same and that relate to VEGF Trap, a VEGF Product
or the Development, Commercialization, manufacture, use, offer for sale or sale
thereof.

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

     1.94 “Lead Litigation Party” shall have the meaning set forth in Section
13.1(b).

     1.95 “Lead Regulatory Party”
shall mean, with respect to each VEGF Product, whichever of (and to the
extent) Aventis or Regeneron has been designated hereunder as having
responsibility for preparing, prosecuting and maintaining Approvals and
Registration Filings relating to such VEGF Product, and for related regulatory
duties.

     1.96 “Legal Dispute” shall mean any dispute, controversy or claim related
to compliance with this Agreement or any Ancillary Agreement (other than the
Stock Purchase Agreement) or the validity, breach, termination or
interpretation of this Agreement or any Ancillary Agreement (other than the
Stock Purchase Agreement).

     1.97 “Litigation Party” shall have the meaning set forth in Section
13.1(b).

     1.98 “Major Market Country” shall mean any of the following:

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

     1.99 “Major Market Profit Split” shall mean the Major Market Profit Split,
defined and calculated as set forth in Schedule 1.

     1.100 “Major Market True-Up” shall have the meaning set forth in Schedule
1.

     1.101 “Manufacturing Cost” shall have the meaning and be calculated in
accordance with Schedule 1.101.

     1.102 “Manufacturing Plan” shall have the meaning set forth in Section
8.7.

     1.103 “Marketing Approval” shall mean Approval required for the marketing
and sale of a VEGF Product in a country in the Territory.

     1.104 “Maximum Regeneron Effort” shall have the meaning set forth in
Section 6.9(a).

11

 

     1.105 “Medical Affairs Cost”
shall mean the product of (a) the number of office-based FTEs supporting
the coordination of Non-Approval Trials related to VEGF Products as agreed upon
in the approved Country Co-Commercialization Plan and Country
Co-Commercialization Budget and/or the Global Co-Commercialization Plan and
Global Co-Commercialization Budget and (b) the applicable Medical Affairs FTE
Rate.

     1.106 “Medical Affairs FTE Rate” shall mean on a country-by-country basis
(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 based upon the fully burdened cost of medical affairs
professionals of major pharmaceutical companies 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 CPI.

     1.107 “Modified Clause” shall have the meaning set forth in Section 20.7.

     1.108 “Net Sales” shall mean the gross amount invoiced for bona fide arms’
length sales of any VEGF Product by or on behalf of Aventis or its Affiliates
or Distributors to Third Parties, less the following deductions, determined in
accordance with Aventis’ standard accounting methods as generally and
consistently applied by Aventis:

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

          (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 VEGF
Products;

          (d) Third Party cash rebates and chargebacks related to sales of the VEGF
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 VEGF
Product, accrued, paid or deducted pursuant to agreements (including, but not
limited to, managed care agreements) or governmental regulations;

          (g) freight, insurance and other transportation charges, to the extent
included in the invoice price;

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

12

 

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

Sales between the Parties, or between the Parties and their Affiliates or
Distributors 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 VEGF
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. In the event that any VEGF Product includes
one or more active ingredients other than VEGF Trap, then, prior to the First
Commercial Sale of such VEGF Product, the Parties shall agree, through the
Finance Sub-Committee, the appropriate method for accounting for sales of such
VEGF Product.

     1.109 “New Information” shall mean any and all ideas, inventions, data,
writings, discoveries, improvements, or materials not generally known to the
public, which may arise or be conceived or developed by either Party or jointly
during the Term to the extent specifically related to any VEGF Product,
including, without limitation, information and data included in the
registration dossier.

     1.110 “New License” shall mean any license approved in writing by the
Parties, other than Existing Licenses, required for the manufacture,
Development or Commercialization of any VEGF Product.

     1.111 “Non-Approval Trial” shall mean any clinical trial of a VEGF Product
other than a Clinical Trial.

     1.112 “Offeror” shall have the meaning set forth in Section 20.16(c).

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

     1.114 “Overhead Charge”
shall mean, beginning in the Contract Year of First Commercial Sale, on a
country-by-country basis for each of the Major Market Countries an amount
agreed upon in local currency by the Parties at least eighteen (18) months
prior to the Anticipated First Commercial Sale in such country to cover
[************************] such amount to be adjusted as of January 1 of each
following calendar year by the percentage increase or decrease, if any, in the
CPI. For the avoidance of doubt, “Overhead Charge” shall not include any
amounts included in Medical Affairs Cost, Sales Force Cost or any other amounts
otherwise included in the definition of “Shared Promotion Expense.”

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

13

 

     1.116 “Party Information” shall mean information or materials provided in
connection with this Agreement or any Ancillary Agreement by either Aventis or
Regeneron or their respective Affiliates to the other Party or its Affiliates,
including, without limitation, by disclosure to any Committee, whether
furnished before or after the Effective Date, including, without limitation,
information and materials in relation to research, development, manufacturing,
promotion, marketing, distributing and selling of VEGF Products hereunder, and
information and materials on substances, formulations, techniques, technology,
equipment, data, reports, Know-How, sources for supply, patent position,
business plans, sales management procedures and other general business and
operational processes and procedures. With respect to each Party, Party
Information includes New Information other than New Information discovered,
invented, authored or otherwise created solely by the other Party.

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

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

     1.119 “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.

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

     1.121 “Phase IIA Clinical Trial” shall mean a dose exploration, dose
response, duration of effect, kinetic/dynamic relationship and/or preliminary
efficacy and safety study of a VEGF Product in the target patient population.

     1.122 “Phase IIB Clinical Trial” shall mean a controlled dose ranging
clinical trial to evaluate further the efficacy and safety of a VEGF Product in
the targeted patient population and to define the optimal dosing regimen.

     1.123 “Plan” shall mean any Global Co-Commercialization Plan, Country
Co-Commercialization Plan, Co-Development Plan, Manufacturing Plan, or other
plan approved through the Committee process relating to the manufacture,
Development or Commercialization of VEGF Products under this Agreement.

     1.124 “Pre-Launch Marketing Expenses” shall mean, with respect to a VEGF
Product, on a Therapeutic Area-by-Therapeutic Area basis, all Shared Promotion
Expenses incurred beginning [***************].

     1.125 “Prescription Drug Marketing Act” or “PDMA” shall mean the
Prescription Drug Marketing Act of 1987, as amended from time to time.

     1.126 “Pricing Approval” shall mean such approval, agreement,
determination or governmental decision establishing prices for a VEGF Product
that can be charged to consumers and will be reimbursed by Governmental
Authorities in countries in the

14

 

Territory where governmental authorities or
Regulatory Authorities of such country approve or determine pricing for
pharmaceutical products for reimbursement or otherwise.

     1.127 “Product Trademark” shall mean, with respect to each VEGF Product,
the trademark selected by the JCC for use on such VEGF Product and/or
accompanying logos, trade dress and/or other indicia of origin, in each case as
selected by the JCC; provided, that the trade dress shall be selected by the
Joint Country Commercialization Sub-Committee in countries where Regeneron
elects to Co-Promote VEGF Products, and in all other countries in the Territory
(other than with respect to Product trademarks used by Regeneron in
Co-Marketing Countries), by Aventis.

     1.128 “Professionals” shall mean physicians and other health care
practitioners who are permitted under the Laws of the Co-Commercialization
Country in which they work to prescribe the VEGF Products.

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

     1.130 “Publishing Party” shall have the meaning set forth in Section 16.3.

     1.131 “Quarterly True-Up” shall mean the Quarterly True-Up, defined and
calculated as set forth in Schedule 1.

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

     1.133 “Regeneron Commitment Level” shall have the meaning set forth in
Section 6.9(a).

     1.134 “Regeneron Development Reimbursement Amount” shall have the meaning
set forth in Schedule 1.

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

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

     1.137 “Regeneron Patent Rights” shall mean those Patent Rights 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) with the right
to sublicense the same and which include at least one
claim which would be infringed by the manufacture, use, sale, offer for
sale or import of any VEGF Product.

15

 

     1.138 “Regeneron Sole Inventions” shall have the meaning set forth in
Section 12.1(a).

     1.139 “Regeneron Trademarks” shall have the meaning set forth in Section
11.3.

     1.140 “Regeneron VEGF Products” shall mean the VEGF Trap Products and all
other VEGF 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) with the right to license or sublicense the same.

     1.141 “Registration Filing” shall mean the submission to the relevant
Regulatory Authority of an appropriate application seeking any Approval, and
shall include, without limitation, any testing, marketing authorization
application, supplementary application or variation thereof, IND, BLA, or any
equivalent applications in any country.

     1.142 “Regulatory Authority” shall mean any federal, national,
multinational, state, provincial or local regulatory agency, department, bureau
or other governmental entity with authority over the testing, marketing,
pricing, reimbursement and/or sale of any VEGF Product in a country in the
Territory, including, without limitation, the FDA in the United States and EMEA
in Europe.

     1.143 “Rest of World Countries” shall mean all countries in the Territory
that are not Major Market Countries, but excluding any Co-Marketing Country.

     1.144 “Rest of World Profit Split” shall mean the Rest of World Profit
Split, defined and calculated as set forth on Schedule 1.

     1.145 “Rest of World True-Up” shall have the meaning set forth in Schedule
1.

     1.146 “Sales Force Cost”
shall mean the aggregate of, for each Therapeutic Area, the product of (a)
the number of FTEs detailing and Co-Promoting VEGF Products as set forth in the
approved Country Co-Commercialization Plan and Country Co-Commercialization
Budget 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 any sales representative
[******************].

     1.147 “Sales Force FTE Rate” shall mean on a country-by-country and
Therapeutic Area-by-Therapeutic Area basis (a) for each of the Major Market
Countries for the Contract Year in which the First Commercial Sale in such
country occurs, a rate agreed upon in local currency by the Parties at least
eighteen (18) months prior to the Anticipated First Commercial Sale in such
country or (b) for each of the Rest of World Countries in which Regeneron has
exercised its option to Co-Promote, for the Contract Year in which Co-Promotion
begins in such country, a rate agreed upon in local currency by the Parties at
the time Regeneron exercises such option, in the case of (a) or (b), based on
the fully burdened field force cost of major pharmaceutical companies in such
country, such rates to be adjusted as of January 1 of each subsequent calendar
year by the percentage increase or decrease, if any, in the CPI.

16

 

     1.148 “Shared Promotion Expenses” shall mean the sum of the following
items, in each case to the extent attributable to Commercialization in the
Major Market Countries or which were incurred in accordance with an approved
Global Co-Commercialization Plan:

          (a) royalties owed to Third Parties on sales in the Major Market
Countries, to the extent listed in Part A of Schedule 3 or owed pursuant to
agreements executed or amended with the prior written approval of both Parties,

          (b) milestones, license fees and all other amounts owed to Third Parties
to the extent listed in Part A of Schedule 3 or owed pursuant to agreements
executed or amended with the prior written approval of both Parties (in each
case, other than any such fees or amounts included in Clinical Supply Cost);

          (c) [********************];

          (d) bad debt attributable to VEGF Products sold in the Major Market
Countries;

          (e) Sales Force Cost;

          (f) Medical Affairs Cost;

          (g) Out-of-Pocket Costs in accordance with an approved Global
Co-Commercialization Plan or Country Co-Commercialization Plan related to (i)
the marketing, advertising and/or promotion of VEGF Products (including,
without
limitation, educational expenses, advocate development programs and
symposia and Promotional Materials), (ii) market research for VEGF Products and
(iii) training and communication materials for VEGF Products;

          (h) a portion of Out-of-Pocket Costs related to the marketing, advertising
and promotion of VEGF Products (including, without limitation, educational
expenses, advocate development programs and symposia, and promotional
materials) to the extent such marketing, advertising and promotion relates to
both VEGF Products and other Aventis products, such portion as agreed upon in
an approved Global Co-Commercialization Plan or Country Co-Commercialization
Plan;

          (i) Out-of-Pocket Costs in accordance with an approved Global
Co-Commercialization Plan or Country Co-Commercialization Plan related to
Non-Approval Trials for VEGF Products, including without limitation the
Out-of-Pocket Cost of CROs, 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 and the Out-of-Pocket Cost for
purchasing, or Manufacturing Cost to manufacture, as the case may be,
comparator agent or placebo requirements;

          (j) Manufacturing Cost of VEGF Products, comparator and/or placebo used in
Non-Approval Trials in accordance with an approved Global Co-Commercialization
Plan or Country Co-Commercialization Plan;

17

 

          (k) Manufacturing Cost of VEGF Products distributed without charge as part
of a compassionate use or patient assistance program;

          (l) Overhead Charge;

          (m) to the extent not covered by a Party’s indemnification obligations
under Article 17, amounts paid, whether in damages or by a settlement approved
by the Parties, to a Third Party in a Major Market Country as a result of any
allegation of (i) infringement by any Party of a Third Party Patent or (ii)
product liability, in each case, by, or as a result of, the manufacture,
Development or Commercialization of a VEGF Product; and

          (n) Out-of-Pocket Costs incurred pursuant to Sections 11.4, 12.2(d),
12.3(b), 13.1(c) or 13.3(c) regardless of whether contained in any approved
budget or related to a Major Market Country.

The foregoing shall not include any Out-of-Pocket Costs or other 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 VEGF Products (to the extent that any Shared Promotion Expense
is attributable, in part, to products or activities other than the VEGF
Products).

     1.149 “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.

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

     1.151 “Stock Purchase Agreement” shall mean the Stock Purchase Agreement,
dated as of the Effective Date, between the Parties, which shall constitute an
Ancillary Agreement.

     1.152 [*****************************].

     1.153 [*****************************].

     1.154 “Supply Agreement” shall have the meaning set forth in Section 8.1,
and shall constitute an Ancillary Agreement.

     1.155 “Technical Development Matter” shall have the meaning set forth in
Section 10.2.

     1.156 “Term” shall have the meaning set forth in Section 19.1(a).

     1.157 “Termination Notice Period” shall have the meaning set forth in
Section 19.2.

18

 

     1.158 “Territory” shall mean all the countries of the world, excluding
Japan.

     1.159 “Therapeutic Area” shall mean each of (i) oncology, (ii) diseases of
the eye, or (iii) any other therapeutic grouping of indications for which any
VEGF Product may be Commercialized other than oncology and diseases of the eye,
such as [*****************].

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

     1.161 “United States” or “U.S.” shall mean the United States of America
(including its territories and possessions and its military bases and
commissaries wherever located in the Territory) and Puerto Rico.

     1.162 “VEGF Products” shall mean
 [*************************************].

     1.163 “VEGF Product Expenses” shall have the meaning set forth in Schedule
1.

     1.164 “VEGF Trap” shall mean [********************************].

     1.165 “VEGF Trap Product” shall mean any pharmaceutical products for human
and/or animal use which includes VEGF Trap as an active ingredient, alone or in
combination with one or more other active ingredients, for any and all
indications.

ARTICLE 2

COLLABORATION

     2.1 Scope of Collaboration. The Parties agree to cooperate in good faith
under this Agreement to Develop and Commercialize VEGF Products in the
Territory in such a manner as to optimize the commercial potential of VEGF
Products. To achieve these goals, the Parties wish to provide for: (a) the
Co-Development of VEGF Products in the Territory; (b) the Co-Promotion of VEGF
Products in the Co-Commercialization Countries; (c) the Co-Marketing of VEGF
Products in the Co-Marketing Countries; (d) the Commercialization of the VEGF
Products in other countries of the Territory; and (e) the manufacture of VEGF
Products within the Territory by the Parties as set forth herein. For purposes
thereof, the Parties shall establish various Committees as set forth in Article
3 of this Agreement to oversee the Development, manufacture and
Commercialization of VEGF Products, 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 confidential Party
Information, including, without limitation, New Information, and such other
information as may be reasonably required for the Parties to operate
effectively and efficiently under this Agreement.

     2.2 Compliance With Law. Both Aventis and Regeneron, and their respective
Affiliates, shall perform their obligations under this Agreement in an effort
to Develop, manufacture, and Commercialize VEGF Products in accordance with
applicable Law. No Party or any of its Affiliates shall, or shall be required
to, undertake any activity under

19

 

or in connection with this Agreement which
violates, or which it believes, in good faith, may violate, any applicable Law.

     2.3 Commercially Reasonable Efforts. Subject to the terms of this
Agreement, each Party (and its Affiliates) shall use Commercially Reasonable
Efforts to fulfill all responsibilities assigned to it under this Agreement and
any then-applicable Plans.

     2.4 Limitation on Exercise of Rights Outside of Collaboration.

          (a) During the Term, neither Party nor any of its Affiliates, either alone
or through any Third Party shall Develop, manufacture for use in the Territory
or Commercialize any VEGF Product in the Territory, except pursuant to this
Agreement.

          (b) Notwithstanding the foregoing subsection (a), if Regeneron presents a
proposal to the JDC to engage in additional Phase IIA Clinical Trials or Phase
IIB Clinical Trials to support potential new indications for the VEGF Product
and the JDC fails to approve the proposal, then Regeneron may, at its option
and at its sole expense, conduct such additional Phase IIA Clinical Trials and
Phase IIB Clinical Trials with respect to the VEGF Products outside the scope
of the Co-Development Plans; provided, however, Regeneron must first present
the proposed protocols and Clinical Trial designs to Aventis for approval, such
approval not to be unreasonably withheld or delayed and shall also present to
Aventis 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). If, in
compliance with this Section 2.4(b), Aventis does not approve any such
protocols or Clinical Trial Designs for safety, efficacy or other clinical
reasons, Regeneron may not proceed with the proposed Phase IIA Clinical Trials
or Phase IIB Clinical Trials unless and until the dispute has been resolved by
the Expert Panel in accordance with Section 10.4. In the event that Regeneron
conducts any such additional Phase IIA Clinical Trials or Phase IIB 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 by Regeneron
pursuant to Article 4 of this Agreement. For the avoidance of doubt, no
additional consideration shall be payable to Regeneron with respect to the
conduct of any such additional Clinical Trials; provided, however, that if the
Parties subsequently agree to commence a further Clinical Trial based on the
results of such additional Clinical Trial(s), then Aventis shall be required to
reimburse Regeneron for the actual Out-of-Pocket Costs and Clinical Supply
Costs incurred in connection with the conduct of such
additional Clinical Trial(s) and consistent with the budgets provided to
Aventis pursuant to this Section 2.4(b) and the other terms of this Agreement.
Nothing in this Section 2.4 shall permit Regeneron to make a Registration
Filing or seek an Approval in the Territory based on any results or data
obtained in conducting the Clinical Trials allowed under this Section 2.4 and
publication of all data and results thereof shall be subject to Article 16.

          (c) Notwithstanding the foregoing subsection (a), if Aventis determines
that an internal product candidate constitutes an Aventis VEGF Product, it
shall promptly present a proposal to the JDC to include such Aventis VEGF
Product in

20

 

the Collaboration on the terms of this Agreement, and, as part of
such presentation, shall provide the JDC with all information with respect to
such Aventis VEGF Product reasonably available to Aventis and material to a
decision by Regeneron’s representatives on the JDC as to whether to approve the
inclusion of such Aventis VEGF Product in the Collaboration. If Regeneron’s
representatives on the JDC approve such inclusion of such Aventis VEGF Product
in the Collaboration, then such Aventis VEGF Product shall be included in the
Collaboration on the terms of this Agreement. If Regeneron’s representatives
on the JDC do not approve such inclusion of such Aventis VEGF Product in the
Collaboration, then Aventis may continue to Develop such Aventis VEGF Product
up to the completion of Phase IIA Clinical Trials, at which time Aventis shall
present to the JDC the available Clinical Trial data with respect to such
Aventis VEGF Product for the approval by Regeneron’s representatives on the
JDC, which approval shall not be unreasonably withheld or delayed. If
Regeneron’s representatives on the JDC do not, consistent with this Section
2.4(c), approve the inclusion of such Aventis VEGF Product in the Collaboration
on the terms of this Agreement, then Aventis may license or otherwise transfer
such Aventis VEGF Product to a Third Party, in which event the Parties shall
share equally the net proceeds received by Aventis from such Third Party after
recovery by Aventis of its expenditures related to such Aventis VEGF Product.

          (d) Notwithstanding the foregoing subsection (a), Aventis may, on a
product-by-product basis, initiate an Aventis-sponsored pivotal Clinical Trial
in a specific tumor indication which combines an Aventis product with a Third
Party VEGF Product, unless: [*********************************]. For any
Aventis sponsored pivotal Clinical Trials for a Third Party VEGF Product not
prohibited by this subsection (d), Aventis shall notify Regeneron prior to
initiating any such trial, such notice to include a brief synopsis of the
protocol.

          (e) Notwithstanding the foregoing subsection (a), Aventis may initiate an
Aventis sponsored pivotal Clinical Trial in [************] so long as Aventis
notifies Regeneron in writing of the commencement of such clinical trial, such
notice to include a brief synopsis of the protocol.

     2.5 Further Assurances and Transaction Approvals. Upon the terms and
subject to the conditions hereof, each of the Parties will use all Commercially
Reasonable Efforts to (a) take, or cause to be taken, all actions necessary,
proper or advisable under applicable Laws or otherwise to consummate and make
effective the transactions contemplated by this Agreement, (b) obtain from the
requisite Governmental Authorities any consents, licenses, permits,
waivers, approvals, authorizations or orders required to be obtained or made in
connection with the authorization, execution and delivery of this Agreement and
the consummation of the transactions contemplated by this Agreement, and (c)
make all necessary filings, and thereafter make any other advisable
submissions, with respect to this Agreement, and the transactions contemplated
by this Agreement required under applicable Laws. The Parties will cooperate
with each other in connection with the making of all such filings, including by
providing copies of all such non-confidential documents to the other Party and
its advisors prior to the filing and, if requested, by accepting all reasonable
additions, deletions or changes suggested in connection therewith. Each Party
will furnish all information required for any applicable

21

 

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.

     2.6 [*******************************************]

     2.7 Compliance with Third Party Agreements. Each Party agrees to comply
with the obligations set forth in (a) the Existing Licenses or 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 such Party’s compliance with (a) any
such Existing License or New License to which it is a party and any such terms
and conditions with which such Party is required to comply as a licensee or
sublicensee, as the case may be, and (b) any such material agreement. Neither
Party may terminate any Existing License, New License or any other material
agreement referred to in clause (b) above with respect to any VEGF Product
without the prior written consent of the other Party, such consent not to be
unreasonably withheld or delayed. Regeneron is currently negotiating the
agreements listed on Part B of Schedule 3 which shall be treated as New
Licenses under this Agreement and which shall require the approval of both
Parties, such approval by Aventis not to be unreasonably withheld or delayed.

     2.8 Plans. The Parties shall undertake all Development and
Commercialization activities in accordance with approved Plans. The Parties
may agree to amend all Plans and budgets from time to time as circumstances may
require.

ARTICLE 3

MANAGEMENT

     3.1 Committees/Management.

          (a) The Parties agree to establish, for the purposes specified herein, a
Joint Steering Committee, a Joint Development Committee, and a Joint
Commercialization Committee. The Parties or such Committees will establish, as
sub-committees of the Joint Commercialization Committee, for each
Co-Commercialization Country, a Joint Country Commercialization Sub-Committee
(each a “Joint Country Commercialization Sub-Committee”). The Parties may
agree to establish a Joint Technical Transfer Committee as a sub-committee of
the JSC. The roles and responsibilities of each Committee are set forth in
this Agreement and may be further designated by the JSC and, in the case of the
Joint Country Commercialization Sub-Committee, the Joint Commercialization
Committee. Each Party shall bear its own costs associated with its
participation in the Committees, and such costs shall not be included in
Development Costs or Shared Promotion Expenses.

          (b) Each of the Committees and the Executive Officers shall exercise their
decision-making authority hereunder in good faith and in a commercially
reasonably

22

 

manner for the purpose of optimizing the commercial potential of and
financial returns from the VEGF Products consistent with other products at a
similar stage in development or product life and of similar market potential
and without regard to any other pharmaceutical product in Development or being
Commercialized or sold by or through a Party or any of its Affiliates (the
“Collaboration Purpose”). 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 The Joint Steering Committee.

          (a) Composition. The Joint Steering Committee (the “JSC”) shall be
established by the Parties to supervise, review and coordinate the performance
of the Parties hereunder. The JSC shall be comprised of senior representatives
from each of Aventis and Regeneron, selected by such Party. The exact number
of representatives of each Party shall be as determined by such Party, but
shall include at a minimum the co-chairpersons of the JDC, JCC, Supply Chain
Sub-Committee, and Finance Sub-Committee and one additional senior
representative from each Party. A Party may change any of its representatives
at any time if a new person is appointed to any of the foregoing positions by
giving written notice to the other Party. Representatives to the JSC shall be
appointed by each Party within thirty (30) days after the Effective Date.

          (b) Co-chairpersons of the JSC. The JSC shall have two co-chairpersons,
one designated by each of Aventis and Regeneron. The co-chairpersons of the
JSC shall be: (i) entitled to set meeting agendas; provided that the agenda
shall include any matter reasonably requested by either Party; (ii) required to
call emergency meetings of the JSC at the request of a Party; and (iii)
required, at the request of either Party, to present JSC disputes that have
been unresolved to the Executive Officers. The
JSC co-chairpersons shall be responsible for recording, preparing and,
within a reasonable time, issuing minutes of the JSC meetings, which meeting
minutes shall be submitted for approval of the members of the JSC.

          (c) Meetings of the JSC. The JSC shall meet whenever any member of the
JSC shall make such a request in writing to the co-chairpersons (including a
request by a Party for an emergency meeting as contemplated by Section 3.2(b))
or whenever a matter is referred to the JSC by any other Committee; provided,
however, that the JSC shall in no event meet less frequently than four times
per year. Decisions of the JSC shall be made unanimously, each Party having
one (1) vote regardless of the number of representatives present or voting;
provided that no such vote shall be valid unless each Party is represented by
at least one member either by proxy or actual presence at the meeting at which
the vote is taken. Subject to appropriate confidentiality undertakings where
applicable, additional participants may be invited by any member of the JSC to
attend meetings where appropriate (e.g., the Alliance Managers, representatives
of regulatory affairs or outside consultants). Such additional participants
shall not be deemed a member of the JSC, nor shall they have any rights or
responsibilities of a member of the JSC.

23

 

     3.3 Responsibilities of the JSC. The responsibilities of the JSC shall be
exercised consistent with this Agreement and shall include, but shall not be
limited to, the following:

          (a) coordinating the various functional representatives in developing and
executing global strategies and plans for the VEGF Products in an effort to
ensure global consistency and efficiency, including, but not limited to,
establishing global marketing guidelines for determining product pricing, the
percentage of sales force incentive compensation linked to VEGF Products and
product positioning with regard to VEGF Products (“Global Marketing
Guidelines”);

          (b) approving target profiles for the VEGF Products;

          (c) reviewing and approving on a timely annual basis the Global
Co-Commercialization Plan (including the related Global Co-Commercialization
Budget), Co-Development Plans (including related Co-Development Budgets)
prepared by the JCC and JDC, as the case may be;

          (d) reviewing each Country Co-Commercialization Plan (including the
related Country Co-Commercialization Budget);

          (e) reviewing and approving the Manufacturing Plan and changes thereto as
submitted by the Supply Chain Sub-Committee;

          (f) reviewing the efforts of the Parties in performing their respective
Co-Development, Commercialization and manufacturing activities;

          (g) reviewing, and as appropriate requesting, additional information with
respect to, the sales performance of the VEGF Products in one or more
countries, or throughout the Territory;

          (h) establishing as sub-committees of the JSC, a Supply Chain
Sub-Committee, Intellectual Property Sub-Committee (“IPSC”), Finance
Sub-Committee and such additional Joint Sub-Committees from time to time, each
of which: (i) shall be composed of representatives of each Party, with
co-chairpersons, and otherwise organized in such a manner as the JSC deems
appropriate; (ii) shall be delegated such responsibilities as the JSC deems
appropriate; and (iii) shall report to the JSC;

          (i) considering and acting upon such other matters as are specified in
this Agreement; and

          (j) attempting in good faith to resolve any disputes referred to it by any
of the other Committee and providing single-point communication for seeking
consensus both internally within the respective Party’s organization and
together regarding key global strategy and plan issues.

     3.4 Joint Development Committee.

24

 

          (a) Composition. The Joint Development Committee (“JDC”) shall be
established by the Parties to, among other things, direct the day-to-day
Development work to be conducted under the Co-Development Plans. Unless
otherwise agreed by the Parties, the JDC shall be comprised of representatives
from each of Aventis and Regeneron, selected by such Party. The exact number
of representatives of each Party shall be as determined by such Party, but
shall constitute at least two senior representatives from each Party’s research
or clinical development organizations, one of whom has responsibility for
overseeing oncology programs and the other of whom has responsibility for
overseeing ophthalmology programs. Within thirty (30) days after the Effective
Date, Aventis and Regeneron will each appoint appropriate representatives to
the JDC.

          (b) Co-chairperson of the JDC. The JDC shall have two co-chairpersons,
one designated by each of Aventis and Regeneron. The co-chairpersons shall be:
(i) entitled to set meeting agendas; provided that the agenda shall include
any matter reasonably requested by either Party; (ii) required to call
emergency meetings of the JDC at the request of a JDC member; and (iii)
required, at the request of either Party, to present disputes (together with a
JDC member of the other Party) to the JSC pursuant to Section 3.12. The JDC
co-chairperson shall be responsible for recording, preparing and, within a
reasonable time, issuing minutes of the JDC meetings, which meeting minutes
shall be submitted for approval of the members of the JDC.

          (c) Meetings of the JDC. The co-chairpersons of the JDC shall call
meetings when deemed by the co-chairpersons to be appropriate or when requested
by a Party; provided, however, that such meetings shall be held on a monthly
basis for the first
year of the Collaboration and on at least a quarterly basis thereafter.
If possible, the meetings shall be held in person (to the extent practicable,
alternating the site for such meetings between the Parties) or where
appropriate, by video or telephone conference. The Parties shall determine the
form of the meeting. Decisions of the JDC shall be made unanimously, each
Party having one (1) vote regardless of the number of representatives present
or voting; provided that no such vote shall be valid unless each Party is
represented by at least one member either by proxy or actual presence at the
meeting at which the vote is taken. Voting by proxy shall be permissible.
Subject to appropriate confidentiality undertakings where applicable,
additional participants may be invited by any member to attend meetings where
appropriate (e.g., representatives of regulatory affairs or outside
consultants). Such additional participants shall not be deemed to be members
of the JDC, or to have any rights or responsibilities of a member of the JDC.

     3.5 JDC Responsibilities The responsibilities of the JDC shall also
include, but shall not be limited to:

          (a) preparing, or overseeing the preparation of, Co-Development Plans (and
related Co-Development Budgets) for final approval by the JSC, and updating
each such Plan not less frequently than once per Contract Year;

25

 

          (b) monitoring compliance with the Co-Development Plans (including the
Co-Development Budgets) and, in connection therewith, reviewing and approving
any changes therein;

          (c) approving protocols for Clinical Trials of VEGF Products in the
Territory, and monitoring and making modifications to such Clinical Trials;

          (d) reviewing and approving material regulatory correspondence, final
study reports, filings and submissions to Regulatory Authorities with respect
to VEGF Products, including BLAs;

          (e) [*************************];

          (f) facilitating an exchange between the Parties of data, information,
material and results relating to the Development of VEGF Products in the
Territory;

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

          (h) preparing procedures for the timely exchange of Adverse Reaction
Reports and other information necessary or useful for regulatory filings
pursuant to the terms of this Agreement; and

          (i) considering and acting upon such other matters as are specified in
this Agreement or by the Joint Steering Committee.

     3.6 Joint Commercialization Committee.

          (a) Composition. The Joint Commercialization Committee (“JCC”) shall be
established by the Parties to, among other things, oversee the global
Commercialization of the VEGF Products in accordance with the Global
Co-Commercialization Plan. Unless otherwise agreed by the Parties, the JCC
shall be comprised of representatives from each of Aventis and Regeneron,
selected by such Party. The exact number of representatives of each Party
shall be as determined by such Party, but shall include at least one senior
representative from each Party’s marketing and sales organization(s). Promptly
after the Effective Date, Aventis and Regeneron will each appoint
representatives to the JCC.

          (b) Co-chairpersons of the JCC. The JCC shall have two co-chairpersons,
one designated by each of Aventis and Regeneron. The co-chairpersons shall be:
(i) entitled to set meeting agendas; provided that the agenda shall include any
matter reasonably requested by either Party; (ii) required to call emergency
meetings of the JCC at the request of a JCC member; and (iii) required, at the
request of either Party, to present disputes (together with a JCC member of the
other Party) to the JSC pursuant to Section 3.12. The JCC co-chairpersons
shall be responsible for recording, preparing and, within a reasonable time,
issuing minutes of the JCC meetings, which meeting minutes shall be submitted
for approval of the members of the JCC.

26

 

          (c) Meetings of the JCC. The co-chairpersons of the JCC shall call
meetings when deemed by the co-chairpersons to be appropriate or when requested
by a Party; provided, however, that such meetings shall be held on at least a
quarterly basis. If possible, the meetings shall be held in person (to the
extent practicable, alternating the site for such meetings between the
companies) or where appropriate, by video or telephone conference. The Parties
shall determine the form of the meeting. Decisions of the JCC shall be made
unanimously, each Party having one (1) vote regardless of the number of
representatives present or voting; provided that no such vote shall be valid
unless each Party is represented by at least one member either by proxy or
actual presence at the meeting at which the vote is taken. Voting by proxy
shall be permissible. Subject to appropriate confidentiality undertakings
where applicable, additional participants may be invited by any member to
attend meetings where appropriate. Such additional participants shall not be
deemed to be a member of the JCC, or to have any rights or responsibilities of
a member of the JCC.

     3.7 JCC Responsibilities. The responsibilities of the JCC shall also
include, but shall not be limited to:

          (a) preparing, or overseeing the preparation of, the Global
Co-Commercialization Plan (and the related Global Co-Commercialization Budget)
for the Commercialization activities to be done centrally, and updating each
such Plan not less frequently than once per Contract Year;

          (b) preparing the overall global strategy for Commercialization of VEGF
Products in the Territory, including, without limitation, VEGF Product
branding, positioning, core messages, and other tactical plans as well as the
overall pricing strategy;

          (c) considering and selecting global Product Trademarks for VEGF Products
and giving guidance to the Joint Country Commercialization Sub-Committee on
trade dress;

          (d) establishing as sub-committees of the JCC the Joint Country
Commercialization Sub-Committees;

          (e) developing and implementing plans and policies regarding journal and
other publications with respect to VEGF Products;

          (f) making recommendations to the JSC with respect to target profiles for
the VEGF Products; and

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

     3.8 Joint Country Commercialization Sub-Committees.

          (a) Composition. Each Joint Country Commercialization Sub-Committee will,
among other things, oversee the local Commercialization in each
Co-Commercialization Country. Unless otherwise agreed by the Parties, each
Joint Country

27

 

Commercialization Sub-Committee shall be comprised of
representatives from each of Aventis and Regeneron, selected by such Party.
The exact number of representatives of each Party shall be as determined by
such Party.

          (b) Co-chairpersons of Each Joint Country Commercialization Sub-Committee.
Each Joint Country Commercialization Sub-Committee shall have two
co-chairpersons, one designated by each of Aventis and Regeneron. The
co-chairpersons shall be: (i) entitled to set meeting agendas, provided that
the agenda shall include any matter reasonably requested by either Party; (ii)
required to call emergency meetings of each Joint Country Commercialization
Sub-Committee at the request of a Joint Country Commercialization Sub-Committee
member; and (iii) required, at the request of either Party, to present disputes
(together with a Joint Country Commercialization Sub-Committee member of the
other Party) to the senior country and/or area management of each Party in the
Territory for such Co-Commercialization Country. The co-chairpersons of each
Joint Country Commercialization Sub-Committee shall be responsible for
recording, preparing and, within a reasonable time, issuing minutes of such
Joint Country Commercialization Sub-Committee meetings, which meeting minutes
shall be submitted for approval of the members of such Joint Country
Commercialization Sub-Committee.

          (c) Meetings of Each Joint Country Commercialization Sub-Committee. The
co-chairperson of each Joint Country Commercialization Sub-Committee shall call meetings when
deemed by the co-chairperson to be
appropriate or when requested by a Party; provided, however, that such meetings
shall be held on at least a quarterly basis. If possible, the meetings shall
be held in person (to the extent practicable, alternating the site for such
meetings between the companies, provided, however, that all such meetings shall
be held in the applicable local country unless otherwise agreed to by the Joint
Country Commercialization Sub-Committee) or where appropriate, by video or
telephone conference. The Parties shall determine the form of the meeting.
Decisions of each Joint Country Commercialization Sub-Committee shall be made
unanimously, each Party having one (1) vote regardless of the number of
representatives present or voting; provided that no such vote shall be valid
unless each Party is represented by at least one member either by proxy or
actual presence at the meeting at which the vote is taken. Voting by proxy
shall be permissible. Subject to appropriate confidentiality undertakings
where applicable, additional participants may be invited by any member to
attend meetings where appropriate. Such additional participants shall not be
deemed to be a member of a Joint Country Commercialization Sub-Committee, or to
have any rights or responsibilities of a member of a Joint Country
Commercialization Sub-Committee.

     3.9 Joint Country Commercialization Sub-Committee Responsibilities.

          (a) The responsibilities of each Joint Country Commercialization
Sub-Committee in each Major Market Country shall also include, but shall not be
limited to:

               (i) preparing, approving and overseeing the preparation of the
applicable Country Co-Commercialization Plan (and the related Country
Co-Commercialization Budget) for the Commercialization activities to be
done in

28

 

such Major Market Country, and updating each such plan not less
frequently than once per Contract Year

               (ii) defining target groups to be covered by overall marketing
efforts in the applicable Major Market Country, including, without
limitation, key opinion leaders, physician groups, hospitals and
regional buying groups, managed care organizations and governmental and
government-affiliate buyers;

               (iii) establishing the trade dress for each VEGF Product,
consistent with the guidelines established by the JCC, in such Major
Market Country;

               (iv) determining the launch date for each VEGF Product in such
Major Market Country, including countries where Pricing Approval is
required;

               (v) reviewing and approving prices, discounts, rebate, reduction,
chargeback and similar policies for such VEGF Product in such Major
Market Country, which shall be consistent with the Global Marketing
Guidelines;

               (vi) preparing short-term and long-term sales forecasts in such
Major Market Country;

               (vii) working with the Supply Chain Sub-Committee to oversee all
recalls, market withdrawals, and any other corrective actions related to
any such VEGF Product in such Major Market Country;

               (viii) (A) preparing a strategy for Non-Approval Trials, (B)
overseeing the design of such trials, and (C) determining which such
trials should be conducted, rejected or redesigned and whether any such
trials should be referred to the JDC for consideration for inclusion in
the Co-Development Plan; and

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

          (b) The responsibilities of each Joint Country Commercialization
Sub-Committee in each Rest of World Country shall be limited to, preparing,
approving and overseeing the preparation of the applicable Country
Co-Commercialization Plan (and the related Country Co-Commercialization Budget)
for the sales and marketing activities to be done in such Rest of World
Country, and updating each such plan not less frequently than once per Contract
Year; provided, however, that the approval by the Joint Country
Commercialization Sub-Committee in such Rest of World Country of the Country
Co-Commercialization Budget for such Rest of World Country shall be limited to
approval of Regeneron’s Sales Force Cost and Regeneron’s Medical Affairs Cost.

29

 

     3.10 Rest of World Countries Which Are Not Co-Commercialization Countries.
In each Rest of World Country in which a VEGF Product is being Commercialized
for which Regeneron has not exercised its right to Co-Commercialize such VEGF
Product, Aventis shall, with respect to such VEGF Product, be responsible for:

          (a) all decisions with respect to Commercialization activities related to
such VEGF Product in such Rest of World Country may be made by, and in the sole
discretion of, Aventis, provided such decisions are in accordance with the
Global Marketing Guidelines;

          (b) informing the JSC of its intent to launch such VEGF Product within six
(6) months of the anticipated launch date;

          (c) informing the JSC of the First Commercial Sale of such VEGF Product;
and

          (d) providing the JSC with such information, with regard to the
Commercialization activities in such Rest of World Country for such VEGF
Product, as the JSC may reasonably request.

     3.11 Alliance Management Representative. Each of Aventis and Regeneron
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”). Each Alliance Manager shall be charged with
creating and maintaining a collaborative work environment within and among the
Committees. Each Alliance Manager will also be responsible for:

          (a) coordinating the various functional representatives of Aventis or
Regeneron, as appropriate, in developing and executing strategies and Plans for
the VEGF Products in an effort to ensure consistency and efficiency;

          (b) providing single-point communication for seeking consensus both
internally within the respective Party’s organization and together 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 JSC in a timely manner.

     3.12 Resolution of Governance Matters.

          (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:

               (i) in the case of any matter which cannot be resolved by a Joint
Country Commercialization Sub-Committee, such matter shall, at the

30

 

request of either Party, promptly, and in any event within thirty (30)
days after such request, be referred to the senior country or area
management of each Party in the Territory for such Co-Commercialization
Country for resolution;

               (ii) in the case of any matter which cannot be resolved by the JDC
or JCC, such matter shall, at the request of either Party, promptly, and
in any event within thirty (30) days after such request, be referred to
the JSC for resolution; and

               (iii) in the event any matter which cannot be resolved by the
senior country and/or area management of each Party pursuant to Section
3.12(a)(i) or by the JSC pursuant to Section 3.12(a)(ii), such matter
shall, at the request of either Party, be resolved in accordance with
the dispute resolution procedures set forth in Sections 3.12(b) and
3.12(c).

          (b) Executive Officers’ Resolution of Disputes. In the event that the JSC
is, after a period of thirty (30) days from the date a matter is submitted to
it for decision, unable to make a decision due to a lack of required unanimity,
either Party may require that the matter be submitted to the Executive Officers for a joint
decision. In such event, the co-chairpersons of the JSC, by written notice to
each Party delivered within five (5) days after receipt of the notice from a
Party pursuant to the immediately preceding sentence, shall formally request
that the dispute be resolved by the Executive Officers, specifying the nature
of the dispute with sufficient specificity to permit adequate consideration by
such Executive Officers. The Executive Officers shall diligently and in good
faith, attempt to resolve the referred dispute within thirty (30) days of
receiving such written notification, failing which, except for Legal Disputes,
either Party may by written notice to the other Party require the specific
issue in dispute to be submitted to a panel of experts in accordance with
Section 10.4, if such dispute is with respect to a Technical Development
Matter.

          (c) Interim Budgets Pending Resolution of Disputes. Pending resolution by
the Executive Officers of any referred dispute, the Executive Officers shall
negotiate in good faith in an effort to agree to appropriate interim budgets
and plans to allow the continued Co-Development and Co-Commercialization of the
VEGF Products pursuant to this Agreement.

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

31

 

ARTICLE 4

LICENSE GRANTS

     4.1 Regeneron License Grants. Subject to the terms and conditions of this
Agreement and any license agreement within the Regeneron Patent Rights,
Regeneron hereby grants to Aventis and its Affiliates the nontransferable
(except as permitted by Section 20.9), co-exclusive (with Regeneron and its
Affiliates) right and license under the Regeneron Intellectual Property to use,
manufacture, import, Co-Develop, Co-Commercialize and Co-Market and the
exclusive right to import, sell and offer for sale, subject to Regeneron’s
right to supply VEGF Products to Aventis as contemplated by this Agreement, the
VEGF Products during the Term throughout the Territory. For the avoidance of
doubt, (i) the foregoing license grant shall not preclude Regeneron from using
or otherwise exploiting, or granting any Person the right to use or otherwise
exploit, Regeneron Intellectual Property anywhere in the Territory for any
purpose other than the manufacture, import, Co-Development,
Co-Commercialization, Co-Marketing, offer for sale and sale of VEGF Products
for the purposes of the Collaboration throughout the Territory and (ii) the
foregoing license grant shall not restrict or prohibit Regeneron’s right
to manufacture and supply Regeneron VEGF Products for importation into or use
or sale in Japan.

     4.2 Aventis License Grants. Subject to the terms and conditions of this
Agreement and any license agreement within the Aventis Patent Rights, Aventis
hereby grants to Regeneron and its Affiliates the nontransferable (except as
permitted by Section 20.9), co-exclusive (with Aventis and its Affiliates)
right and license under the Aventis Intellectual Property to use, manufacture,
import, Co-Develop, Co-Commercialize and Co-Market the VEGF Products during the
Term for the purposes of the Collaboration throughout the Territory. For the
avoidance of doubt, the foregoing license grant shall not preclude Aventis from
using or otherwise exploiting, or granting any Person the right to use or
otherwise exploit, Aventis Intellectual Property anywhere in the Territory for
any purpose other than the manufacture, import, Co-Development,
Co-Commercialization and Co-Marketing of VEGF Products for the purposes of the
Collaboration throughout the Territory.

     4.3 Sublicenses; Subcontracting. Unless otherwise restricted by any
Existing License or New License, the rights granted to either Party and its
Affiliates under the Regeneron Intellectual Property or Aventis Intellectual
Property, as applicable, are sublicensable with the prior written consent of
the other Party, which consent shall not be unreasonably withheld, conditioned
or delayed; provided, however that nothing shall prevent (A) Aventis from
sublicensing its rights to a Distributor to sell or offer to sell the VEGF
Product in any Rest of World Country and (B) Regeneron from sublicensing its
rights to a Distributor to sell or offer to sell the VEGF Product in any
Co-Marketing Country that would otherwise have been a Rest of World Country.
For the avoidance of doubt, each Party may withhold such consent if it
reasonably determines such sublicense would reduce its financial return from
the Collaboration in the applicable country. Each Party shall remain
responsible and liable for the compliance by its Affiliates and permitted
sublicensees and Distributors with applicable terms and obligations set forth
herein. Each Party agrees that any sublicense granted pursuant to this Article
4 or Article

32

 

11 shall be consistent with, and expressly subject to, the
covenants, terms and conditions set forth in this Agreement. Promptly after
entering into any such sublicense, or any amendment or modification thereto,
the Party granting the license will provide a true and correct copy thereof to
the other Party. Each Party shall also have the right to contract with one or
more Third Parties to perform certain of its obligations under the Plans if
specifically contemplated therein, provided that such Party shall remain
responsible and liable for the acts and omissions of such Third Party service
providers and such Third Parties undertake in writing obligations of
confidentiality and non-use of Party Information which are substantially the
same as those undertaken by the Parties under this Agreement. In the event of
a breach by a sublicensee or a Third Party contractor of any sublicense or
subcontract granted or awarded hereunder by a Party which has or is reasonably
likely to have a material adverse effect on the other Party or the other
Party’s Intellectual Property, then the other Party may cause the Party to
exercise, and the Party will promptly exercise, any termination rights it may
have under the sublicense or subcontract with such sublicensee or Third Party contractor. All sublicenses and subcontracts
granted under this Agreement will terminate upon termination or expiration of
this Agreement.

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

     4.5 Technology Transfer. To the extent reasonably necessary for each
Party to exercise its rights and perform its obligations under this Agreement
with respect to the other Party’s intellectual property, and from time to time
during the Term, each Party shall provide to the other Party one (1) copy of
books and records embodying such Party’s applicable intellectual property, to
the extent such books and records may exist or be created in the ordinary
course of business. Without limiting the generality of any other provision of
this Agreement, in accordance with the Co-Development Plan, each Party shall
make its scientific and technical personnel reasonably available to the other
Party to answer questions or provide instruction as reasonably necessary with
respect to such Party’s intellectual property, including Know-How, licensed to
the other Party hereunder.

ARTICLE 5

DEVELOPMENT ACTIVITIES

     5.1 Co-Development of VEGF Products. Subject to the terms of this
Agreement, the Parties shall undertake Development activities with respect to
the VEGF Products under the direction and oversight of the Committees and in
accordance with all applicable Co-Development Plans. Each Party shall use
Commercially Reasonable Efforts to Develop the VEGF Products in the Territory,
carry out the Development activities assigned to it in such Co-Development
Plans, and conduct all such activities in compliance with applicable Laws,
including, without limitation, Good Practices and export and import control
Laws. The Parties intend to conduct Development activities in support of the
VEGF Products in the fields of oncology, ophthalmology, and such other

33

 

Therapeutic Areas designated by the JDC pursuant to the terms of this
Agreement, and, in the Development of VEGF Products, the Parties will use
Commercially Reasonable Efforts to differentiate for commercial purposes VEGF
Products in different Therapeutic Areas. Except as set forth in Sections 2.4
and 2.6, no Party shall sponsor or initiate any Clinical Trial that has not
been approved by the JDC.

     5.2 Co-Development Plans. Subject to the terms of Article 3 above, the
JDC shall annually prepare Co-Development Plans for VEGF Products for approval
by the JSC. Each Co-Development Plan shall incorporate a Co-Development Budget
and, except for the initial Co-Development Plan referred to below in this Section 5.2, will be prepared
by the JDC to enable JSC approval at least two (2) months prior to the end of
the then current Contract Year. Each Co-Development Plan will set forth the
plan for Development of each VEGF Product on a calendar-year basis: (a)
strategies for Developing and obtaining Approvals for the VEGF Products; and
(b) allocation of responsibilities for Development activities between the
Parties, and/or to Third Party service providers to the extent permitted by the
applicable Co-Development Plan. The activities agreed to by the Parties
(together with the associated estimated budget covering the period through
December 31, 2004) as set forth on Schedule 5 shall constitute the initial
co-development plan (the “Initial Co-Development Plan”). The JDC will meet
after the Effective Date to finalize a Co-Development Plan, subject to the
review and approval of the JSC, based on the Initial Co-Development Plan.
Schedule 5 also sets forth the on-going Clinical Trials for the VEGF Products
and the activities that are ongoing and that will need to be completed after
the Effective Date as well as the expected budgets for such remaining
activities. For the avoidance of doubt, Aventis shall only be responsible for
the Development Costs of such on-going Clinical Trials that arise after the
Effective Date and Regeneron will remain responsible for all other Development
Costs for such on-going Clinical Trials; provided, however such Development
Costs relating to such Clinical Trial(s) which are ongoing as of the Effective
Date and for which Aventis shall be responsible for paying shall include any
cost and expense reasonably allocated to the conduct of such Clinical Trial(s)
on or after the Effective Date in accordance with GAAP plus Regeneron’s cost of
clinical supplies of drugs used after the Effective Date. Estimated
Development Costs relating to such ongoing Clinical Trial(s) are included
within the Co-Development Budget included within the Initial Co-Development
Plan. Unless otherwise agreed to by the JDC, each subsequent Co-Development
Plan covering Clinical Trials and other activities included within the Initial
Co-Development Plan shall be substantially consistent with the Initial
Co-Development Plan and designed to complete as expeditiously as is
commercially reasonable such Clinical Trials and other activities described or
referred to in the Initial Co-Development Plan. Unless otherwise agreed by the
JDC, it is understood that [***********************]; (b) the JDC will
determine the appropriate Party for conducting and overseeing preclinical
Development in all Therapeutic Areas; and (c) each of the Parties will have an
active involvement in conducting and overseeing clinical Development for each
Therapeutic Area for which the other Party has primary responsibility.

     5.3 Co-Development Reports. Within forty-five (45) days after the end of
each calendar quarter, Regeneron and Aventis shall each provide to the other
Party a

34

 

written report (in electronic form) summarizing the material activities
undertaken by such Party during such quarter in connection with each
Co-Development Plan, together with a statement of Development Costs incurred by
such Party during such quarter.

ARTICLE 6

COMMERCIALIZATION

     6.1 Commercialization of VEGF Products in Co-Marketing Countries
In the event (and for so long as) the Parties are not permitted under
local Law to Co-Promote a VEGF Product in a country in the Territory, but are
permitted to Co-Market such VEGF Product in such country, then Regeneron may
elect, prior to First Commercial Sale in such country of such VEGF Product, to
Co-Market the VEGF Product in such country in accordance with this Section 6.1
and, to the extent not inconsistent therewith and not prohibited by applicable
Law in such country, in accordance with the obligations set forth in this
Article 6 and the other provisions of this Agreement. Aventis shall supply
Regeneron at Aventis’ Manufacturing Cost with its Commercial Supply
Requirements of VEGF Products in the Co-Marketing Countries to the extent
reasonably available giving higher priority to the Commercial Supply
Requirements of countries consistent with their relative contribution to the
overall commercial potential of the VEGF Products, and giving equal priority to
Aventis’ Commercial Supply Requirements in such Co-Marketing Countries. In the
event any such provisions of this Agreement are prohibited by applicable Law in
a Co-Marketing Country, then such provision shall be considered a Severed
Clause under Section 20.7 solely with respect to such Co-Marketing Country.

     6.2 Co-Commercialization of VEGF Products in Co-Commercialization
Countries

          (a) Exercise of Option by Regeneron. In the event that Regeneron desires
to Co-Promote a VEGF Product in a particular Co-Commercialization Country for
use in a Therapeutic Area, Regeneron shall notify Aventis of [****************]
If Regeneron does not timely notify Aventis of its preliminary indication or
of its final decision within the periods set forth in clause (i) or (ii) above,
as applicable, Regeneron shall not be entitled to exercise its option to
Co-Promote such VEGF Product in such Co-Commercialization Country for use in
such Therapeutic Area until on or after the [************************].

          (b) Co-Commercialization. Aventis and Regeneron (through their respective
Affiliates where appropriate) shall Co-Commercialize VEGF Products under the
applicable Product Trademarks in each Co-Commercialization Country in
accordance with the then-current and applicable Country Co-Commercialization
Plan and Country Co-Commercialization Budget. Each Party shall use, or shall
cause its local Affiliates to use, Commercially Reasonable Efforts to
Co-Commercialize the VEGF Products in the Co-Commercialization Countries, carry
out the activities assigned to it in the applicable Country
Co-Commercialization Plan and conduct all such activities in compliance with
applicable Laws. Each Party shall ensure that its Commercialization activities
conform with the parameters in the approved Country Co-Commercialization Plan
and the Global Co-Commercialization Plan. No Party may initiate or sponsor any
Non-Approval Trial in

35

 

a Co-Commercialization Country without prior approval
from the applicable Joint Country Commercialization Sub-Committee.

          (c) Decision to Discontinue Co-Commercialization. In the event that
Regeneron decides it no longer wishes to Co-Commercialize a VEGF Product in a
particular Co-Commercialization Country for use in a Therapeutic Area or
does not wish to maintain its minimum sales force FTE requirement for use in
such Therapeutic Area, Regeneron must give Aventis [***] prior
written notice of such decision. At the end of such [***]
period, Regeneron shall cease all Co-Commercialization activities with respect
to such VEGF Product in such Co-Commercialization Country for use in such
Therapeutic Area. Once Regeneron exercises its rights to cease
Co-Commercializing in a Co-Commercialization Country for use in a Therapeutic
Area, Regeneron will not again be able to exercise its rights pursuant to
Section 6.2(a) to Co-Commercialize such VEGF Product in such
Co-Commercialization Country, except with the prior written consent of the
Joint Country Commercialization Sub-Committee with respect to such
Co-Commercialization Country, such consent not to be unreasonably withheld or
delayed, it being understood that it shall not be unreasonable for such consent
to be withheld if Aventis’ representatives on such Joint Country
Commercialization Sub-Committee reasonably determine that such Co-Promotion
would be inconsistent with the Collaboration Purpose or would require Aventis
to unreasonably restructure its sales force. Regeneron shall have the right to
recommence Co-Commercialization of a VEGF Product in a Co-Commercialization
Country for use in a Therapeutic Area terminated pursuant to this Section
6.2(c) only once. Any such recommencement will occur no earlier than
[**********] after Regeneron’s request therefor.

     6.3 Co-Commercialization Plans. The initial Country Co-Commercialization
Plan and Country Co-Commercialization Budget for each VEGF Product in each
Co-Commercialization Country will be prepared by the applicable Joint Country
Commercialization Sub-Committee at least [**********] before the Anticipated
First Commercial Sale of such VEGF Product in such Co-Commercialization
Country. Each Country Co-Commercialization Plan and Country
Co-Commercialization Budget for each subsequent Contract Year shall be prepared
by the applicable Joint Country Commercialization Sub-Committee at least
[**********] prior to the end of the then current Contract Year. For the
avoidance of doubt any disputes regarding a Country Co-Commercialization Plan
or Country Co-Commercialization Budget shall be determined in accordance with
Section 3.12. Each Country Co-Commercialization Plan and Country
Co-Commercialization Budget shall include, as applicable:

          (a) strategies for Co-Promoting the VEGF Products, including recommended
target Professionals for such activities, Strengths, Weaknesses, Opportunities
and Threats analysis and competitive analysis;

          (b) the allocation between the Parties of responsibilities for marketing,
sales and promotional activities and, with respect to sales representatives,
the percentage of such representatives’ time dedicated to the sale of VEGF
Products, which shall be

36

 

commensurate with the percentage of total annual
incentive payments which will be payable to such representatives in respect of
their sales of VEGF Products;

          (c) anticipated marketing, sales and promotion efforts by each Party (or
its Affiliates);

          (d) market and sales forecasts in a form to be agreed between the Parties
via the applicable Joint Country Commercialization Sub-Committee;

          (e) advertising, public relations and other promotional programs and
sampling, to be used in the Co-Promotion;

          (f) patient advocacy programs, medical affairs programs, including
professional symposia and other educational activities, and medical affairs
studies based upon Joint Country Commercialization Sub-Committee-approved
protocols;

          (g) reimbursement and patient assistance, [*********************];

          (h) Non-Approval Trials in the applicable Co-Commercialization Country
relating to the VEGF Products, which trials shall be based upon Joint Country
Commercialization Sub-Committee-approved protocols; and

          (i) as appropriate, a training plan for the Parties’ sales
representatives.

In addition to the detailed plan and budget for the next upcoming calendar
year, each Country Co-Commercialization Plan and Country Co-Commercialization
Budget will include an outline of the projected plan and estimated budget for
the following calendar year.

     6.4 Co-Commercialization Reports.

          (a) Within forty-five (45) days after the end of each calendar quarter
commencing after the First Commercial Sale (or such earlier agreed upon
calendar quarter, as appropriate), Regeneron and Aventis shall each provide to
the other Party, in electronic form, a Country Co-Commercialization Report.

          (b) Each Party shall, on a periodic and reasonably current basis, keep the
applicable Joint Country Commercialization Sub-Committee informed regarding the
activities of its sales representatives in promoting the VEGF Products,
including information relating to market developments, acceptance of the VEGF
Products, product quality complaints, and similar information.

     6.5 VEGF Product Pricing and Pricing Approvals. Aventis shall present to
the applicable Joint Country Commercialization Sub-Committee for approval
proposals for the terms and conditions of sale of each VEGF Product in each
Co-Commercialization Country, including proposed pricing, pricing changes,
requests for reimbursements, and parameters for any discount or rebate
programs. Final decisions concerning VEGF Product conditions of sale, pricing,
and discount/rebate programs shall be consistent with

37

 

the Global Marketing
Guidelines. Aventis will be solely responsible for using Commercially
Reasonable Efforts to seek and obtain Pricing Approval in the
Co-Commercialization Countries as well as all other countries of the Territory,
subject to any pricing parameters established by the JSC. Regeneron shall have
the right to participate in any material meetings or the preparation of any
material submissions to Governmental Authorities in the Co-Commercialization
Countries as well as the United States even if Regeneron has not exercised its
right to Co-Promote in the United States.

     6.6 Booking of Sales and VEGF Product Distribution. Aventis (or its local
Affiliate) shall invoice and book, and appropriately record, all sales of the
VEGF Products in the Co-Commercialization Countries as well as all other
countries in the Territory (except that Regeneron shall also invoice and book,
and appropriately record, its sales of VEGF Products in the Co-Marketing
Countries). Aventis (or its local Affiliate) shall also be responsible for the
distribution of the VEGF Products and for paying Medicaid and other
governmental rebates which are due and owing with respect to the VEGF Products
in the Co-Commercialization Countries as well as all other countries in the
Territory (except that Regeneron shall be responsible for the VEGF Products
sold by Regeneron in the Co-Marketing Countries).

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

     6.8 Contract Sales Force. Each Party shall be entitled to discharge its
annual FTE effort with respect to Commercialization of any VEGF Product in any
Co-Commercialization Country by engaging a Contract Sales Force to the extent
such Contract Sales Force is used [**********]. If a Party (or its local
Affiliate) retains a Contract Sales Force in a Co-Commercialization Country,
that Party (or its local Affiliate) will be responsible for (i) all costs
associated with retaining such Contract Sales Force above approved Sales Force
Cost included in the applicable Country Co-Commercialization Budget and for the
Contract Sales Force’s compliance with this Agreement, including, without
limitation, the training and monitoring of such Contract Sales Force and
ensuring compliance with all applicable Laws, and (ii) ensuring that sales
representatives in such Contract Sales Force have minimum skill levels
customary for sales representatives in major pharmaceutical companies in such
country in the relevant Therapeutic Area.

     6.9 Co-Commercialization FTE Efforts.

38

 

          (a) FTE Efforts. Each Country Co-Commercialization Plan shall specify the
FTE effort to be provided by each of the Parties in the applicable
Co-Commercialization Country. Upon the exercise of its election to Co-Promote
pursuant to Section 6.2(a) in a Co-Commercialization Country, Regeneron will
provide to Aventis a binding notice of the FTE effort that Regeneron commits to
deliver with respect to such VEGF Product in each Co-Commercialization Country
(and in each Therapeutic Area) during the first Contract Year for which
Regeneron exercised its right to Co-Promote (the “Regeneron Commitment Level”).
Subject to the provisions of Section 6.9(b) and in accordance with Section
6.2(b), in the event that Regeneron elects to Co-Promote in a
Co-Commercialization Country in a Therapeutic Area, then (i) in a Major Market
Country, in no event shall the Regeneron Commitment Level be less than
[********************************], unless otherwise agreed by the Parties, and
(ii) in all other countries the Regeneron Commitment Level shall be as agreed
by the Parties. In no event shall the Regeneron Commitment Level exceed fifty
percent (50%) of the anticipated total FTE effort in such Co-Commercialization
Country for the Therapeutic Area (the “Maximum Regeneron Effort”).
[**************]. Regeneron’s binding notice referred to above in this Section
6.9(a) shall be accompanied by a plan (which shall be developed by Regeneron in
cooperation with Aventis and shall be intended to coordinate and integrate the
Parties’ respective FTE efforts and detailing activities) for ensuring that
Regeneron will have in place a field force of qualified sales representatives
to satisfy the Regeneron Commitment Level. In each Co-Commercialization
Country, Aventis shall perform the anticipated total FTE effort above the
Regeneron Commitment Level.

          (b) Changes in Regeneron Commitment Level. In the event that during the
[***********], the FTE effort for a VEGF Product is expected to be materially
different from the previously anticipated total FTE effort for such VEGF
Product, then Regeneron may request that the Parties meet, and in such event
the Parties shall promptly meet, to discuss whether to make changes to the
Regeneron Commitment Level for such VEGF Product. Regeneron may otherwise
change the Regeneron Commitment Level in a Co-Commercialization Country by
giving Aventis at least [**********] written notice; provided, however, that in
no event may the Regeneron Commitment Level exceed the Maximum Regeneron
Effort, and provided, further, that any increase in the Regeneron Commitment
level shall not be effective if Aventis reasonably determines that such change
would have an adverse effect on the Parties’ shared goal of optimizing the
commercial potential of the applicable VEGF Product.

          (c) FTE Effort and Performance of Details. Each Party’s (or its local
Affiliate’s) sales representatives shall provide the FTE effort and detail the
VEGF Products in each Co-Commercialization Country in accordance with the
approved Country Co-Commercialization Plan. Each Party shall be obligated to
deploy the required number of sales representative FTEs for the VEGF Products
set forth in the Country Co-Commercialization Plan. [*****************].

          (d) FTE Record Keeping. Each Party (through its local Affiliates where
appropriate) shall maintain records relating to its sales representative FTEs
for the VEGF Products in the Co-Commercialization Countries in a manner
sufficient to permit

39

 

the determination of the Sales Force Cost and the
incentive compensation requirements set forth in Section 6.9(c) above in each
Co-Commercialization Country.

     6.10 Training.

          (a) Each Party (through its local Affiliates where appropriate) shall, at
its own expense, comply with the training plan contained in any Country
Co-Commercialization Plan.

          (b) Prior to the First Commercial Sale in any Co-Commercialization
Country, the Parties (through their local Affiliates where appropriate) shall
jointly develop sales training materials for use in training each Party’s sales
representatives with respect to their activities in such Co-Commercialization
Country. The Parties (through their local Affiliates where appropriate) will
thereafter cause their training personnel to train their field sales
representatives with such training materials and Promotional Materials with
respect to their activities in such Co-Commercialization Country.

          (c) If either Party (including through any of its respective local
Affiliates) organizes material VEGF Product-related meetings of its employees
(such as launch meetings) for a particular Co-Commercialization Country, it
will make Commercially Reasonable Efforts to give the other Party (or its local
Affiliate) advance notice of any such meetings. If requested by the other
Party (or its local Affiliate), the Party (or its local Affiliate) organizing
such meetings will permit representatives of the other Party (or its local
Affiliate) to attend and participate in such meetings or such portions thereof
which relate solely to the Co-Commercialization of the VEGF Products at their
own cost. In such event and to the extent possible, the Party organizing such
meeting shall keep the VEGF Product-related portions of such meetings
independent from other matters.

          (d) In a manner determined by the applicable Joint Country
Commercialization Sub-Committee, the Parties (through their local Affiliates
where appropriate) will coordinate the detailing, sales meetings, contacts with
wholesalers and retailers, targeting of healthcare organizations, speaker
programs and, as appropriate, medical affairs and/or support activities for
relevant Non-Approval Trials as provided in the relevant Country
Co-Commercialization Plan.

     6.11 Promotional Materials. In the Co-Commercialization Countries, the
Parties and their Affiliates shall only use the Promotional Materials and only
conduct marketing and promotional activities for the VEGF Products which, in
each case, are provided for in the relevant Country Co-Commercialization Plan
and are approved by the applicable Joint Country Commercialization
Sub-Committee. In each Co-Commercialization Country, the
applicable Joint Country Co-Commercialization Sub-Committee will prepare
Promotional Materials for the VEGF Products which are intended for use within
such Co-Commercialization Country. Aventis will have primary responsibility,
with Regeneron’s participation, for the preparation of Promotional Materials
intended for use in a Co-Commercialization Country. Each Party shall send to
its regulatory compliance personnel samples of the Promotional Materials and
such

40

 

regulatory personnel shall review and either approve or state their
reasons for disapproval of such Promotional Materials in writing within ten
(10) Business Days following its receipt of such sample. Aventis shall be
responsible for the distribution of Promotional Materials for use in the
Co-Commercialization Country and shall ensure that Regeneron’s sales
representatives are provided with reasonable quantities of Promotional
Materials consistent with the Regeneron Commitment Level for such
Co-Commercialization Country in accordance with the approved Country
Co-Commercialization Plan. The Parties shall jointly own all rights to all
Promotional Materials, including all copyrights thereto. All Promotional
Materials generated for a Co-Commercialization Country shall be maintained in
confidence and shall not be disclosed or distributed to Third Parties, until
such time as they have been reviewed and approved as set forth in this Section.
In all countries other than the Co-Marketing Countries, Aventis shall be
responsible for preparing all Promotional Materials for the VEGF Products which
are intended for use within such countries, which shall, to the extent that
such materials relate to the VEGF Products in the case of multiple product
materials, be approved by the Joint Country Commercialization Sub-Committee;
provided, however, if Regeneron has not exercised its right to Co-Promote in a
Major Market Country, the JCC shall approve the Promotional Materials intended
for use in that Major Market Country. At the request of the JSC, Aventis
Affiliates in the Rest of World Countries shall send representative samplings
of Promotional Materials used in such countries to the JSC for review.

     6.12 Promotional Claims/Compliance. Neither Party (nor any of its
respective Affiliates) shall make any medical or promotional claims for any
VEGF Product other than as permitted by applicable Laws. When distributing
information related to any VEGF Product or its use (including information
contained in scientific articles, reference publications and publicly available
healthcare economic information), each Party (and its respective Affiliates)
shall comply with all applicable Laws (and, with respect to the U.S., in
accordance with the Pharmaceutical Research Manufacturers of America Code on
Interactions with Healthcare Professionals).

     6.13 Samples. Aventis shall provide Regeneron with VEGF Product samples
as required in the applicable Country Co-Commercialization Plan and as decided
by the Joint Country Commercialization Sub-Committee. Aventis and Regeneron
(and their respective Affiliates) shall use samples strictly in accordance with
the then-applicable, approved Country Co-Commercialization Plan and shall store
and distribute samples in full compliance with applicable Laws, including the
requirements of the PDMA. Each Party (and its local Affiliates) will maintain
those records required by the PDMA and all other Laws and shall allow representatives of the other Party to inspect such
records and storage facilities for the VEGF Product samples on request.

     6.14 [******************]

     6.15  Inventory Management. Aventis, with respect
to each Co-Commercialization Country, shall use Commercially Reasonable Efforts
to manage VEGF Product inventory on hand at wholesalers and other Distributors
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.

41

 

     6.16 Medical and Consumer Inquiries. The applicable Joint Country
Commercialization Sub-Committee or the JCC in the United States if Regeneron
has not exercised its right to Co-Promote in the United States shall delegate
responsibility for responding to medical questions or inquiries from members of
the medical and paramedical professions and consumers regarding VEGF Products
in the applicable country. In the Co-Commercialization Countries and the
United States, if not a Co-Commercialization Country, each Party shall refer
all such questions about VEGF Products that it receives to the Party or Parties
responsible for responding thereto as set forth herein, and each Party shall
inform the other Party of any answers given, all in accordance with the laws,
regulations and policies of the FDA. In the Co-Commercialization Countries and
the United States, if not a Co-Commercialization Country, the Parties shall
work together to formulate, and shall mutually agree upon, responses to such
inquiries, including the content of any Frequently Asked Questions (FAQs). If
appropriate, the Parties shall establish a centralized database to document and
track medical inquiries. If Regeneron receives any questions about VEGF
Products in a country other than the Co-Commercialization Countries or the
United States, if not a Co-Commercialization Country, Regeneron shall refer all
such questions to Aventis and Aventis shall be responsible for responding
thereto.

     6.17 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
market, price and sell a VEGF Product in such country, and (b) no generic
equivalent of a VEGF Product is marketed in such country.

     6.18 Non-Compete. During the Term, except as expressly permitted by
Section 2.4, neither Aventis nor Regeneron (nor their respective Affiliates or
sublicensees under this Agreement) shall, directly or indirectly, either alone
or through any Third Parties, Develop, manufacture for use or sale in any part
of the Territory, or Commercialize any VEGF Products in the Territory except for VEGF Products Developed, manufactured
or Commercialized pursuant to this Agreement. In the event that (i) Regeneron
terminates this Agreement for any reason or (ii) Aventis terminates this
Agreement for any reason other than pursuant to Section 19.3 or Section 19.4,
[****************], Aventis (nor its respective Affiliates or sublicensees
under this Agreement) shall not, directly or indirectly, Commercialize any VEGF
Products in any part of the Territory. In the event that Aventis 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 VEGF Products in any part
of the Territory other than VEGF Products as to which, as of the effective date
of such termination, Regeneron continues to have ownership of, and/or pursuant
to Schedule 8, has a post-termination license right. A Party shall not be
considered in breach of this Section 6.18 solely by reason of the acquisition
by such Party of a Person (a) if such Party includes the offending VEGF
Product(s) in the licenses granted to the other Party pursuant to this
Agreement or (b) prior to the closing of such acquisition, the acquiring Party
commits in writing to the other Party that, promptly following the closing of
such

42

 

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 VEGF Product(s) or includes the offending VEGF
Products(s) in the licenses granted to the other Party pursuant to this
Agreement.

     6.19 Post Marketing Clinical Trials. Subject to the provision of this
Agreement, the Parties shall use Commercially Reasonable Efforts to comply with
any Clinical Trial obligations with respect to registration Approval with
respect to any VEGF Product in any country in the Territory, imposed by
applicable Law, pursuant to the approvals or required by a Regulatory
Authority.

ARTICLE 7

CLINICAL AND REGULATORY AFFAIRS

     7.1 Ownership of Approvals and Registration Filings.

          (a) Regeneron shall own all Approvals and Registration Filings, with
respect to the VEGF Products in the United States and shall have the rights and
obligations set forth in Sections 7.2 to 7.4 (inclusive) with respect thereto.
[*******************************].

          (b) [*************].

          (c) Regeneron in the United States and Aventis in all countries outside of
the United States in the Territory shall license, transfer, provide a letter of
reference with respect to, or take other action necessary to make available the
relevant Registration Filings and Approvals to and for the benefit of the other
Party.

     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 VEGF Product in the jurisdiction as to which it is the Lead
Regulatory Party; provided that it shall adhere to the obligations in this
Article 7. The Lead Regulatory Party shall perform all such activities in
accordance with the Co-Development Plans, Global Co-Commercialization Plans,
applicable Country Co-Commercialization Plans, and all applicable Laws.

          (b) The Parties shall establish procedures to ensure that the Parties
exchange on a timely basis all necessary information to enable the Lead
Regulatory Party to comply with all regulatory obligations on a global basis,
including, without limitation, filing updates or supplements with Regulatory
Authorities, pharmacovigilance filings, manufacturing supplements, and
investigator notifications to Regulatory Authorities. The Parties shall
provide to each other prompt written notice of any Approval of a VEGF

43

 

Product. Whenever possible, the Lead Regulatory Party shall give the other Party
adequate time to review and comment on all material submissions to Regulatory
Authorities relating to a VEGF Product, including, without limitation, those
related to Pricing Approvals. The Parties will meet to discuss in good faith
any disputes on the contents of filings or submissions to Regulatory
Authorities and such disputes shall be submitted to the JDC for timely
resolution.

          (c) The Parties shall work together cooperatively (i) in the preparation
of proposed product labeling and any negotiations with Regulatory Authorities
regarding VEGF Product labeling, (ii) in the preparation of regulatory
strategies with respect to all regulatory actions, communications, filings and
submissions, including any supplements and amendments to Registration Filings,
(iii) to prepare for advisory committee or any other regulatory meeting
concerning VEGF Products, and (iv) in the response to Regulatory Authorities to
any of the communications or inquiries referred to in Section 7.5(b)(i)-(vi).
Such cooperation shall include providing the other Party with prompt written
notice of material pending submissions and/or meetings with Regulatory
Authorities and an opportunity to actively participate in the drafting of
material submissions and active participation in meetings and telephone
conferences. These regulatory matters shall be conducted with the guidance of
the JDC (and the Joint Country Commercialization Sub-Committee, if applicable).
The JDC shall oversee the implementation of a plan for the global registration
and regulatory strategy for Registration Filings in the Territory, including
the schedule for such filings and submissions. All material regulatory
decisions for the VEGF Products shall be made through the JDC.

          (d) Without limiting anything in this Section 7.2, in the United States,
the Lead Regulatory Party for the applicable IND or BLA, as the case may be,
shall use all reasonable efforts to provide the other Party with reasonable
advance written notice of any filings, submissions, meetings, telephone
conferences and/or other discussions by or of such Lead Regulatory Party with
the FDA, scheduled or unscheduled, that pertain to the applicable VEGF Product,
and, consistent with applicable Laws, and shall use all reasonable efforts to
afford the other Party’s representatives an opportunity to actively participate
in the drafting and review of such filings and submissions, and to attend and
actively participate in all such meetings, telephone conferences and/or
discussions with the FDA, and shall provide the other Party with copies of all
such filings and submissions of and of any minutes of any such meetings,
telephone conferences and/or discussions. In addition, the Lead Regulatory
Party for the applicable IND or BLA, as the case may be, shall use all
reasonable efforts to provide the other Party with all information, data and
materials reasonably necessary for the other Party to participate in such
activities, said items to be provided to the other Party, where possible, at
least seven (7) days in advance of the date on which the applicable activity is
expected to occur. The Parties will meet to discuss in good faith any disputes
on the contents of filings or submissions to the FDA and disputes shall be
submitted to the JDC for timely resolution.

          (e) [*******************************].

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     7.3 Regulatory Meetings Outside the United States. Aventis shall be
responsible for interfacing, corresponding and meeting with the applicable
Regulatory Authorities and Governmental Authorities with respect to each VEGF
Product in the Territory outside the United States. Regeneron shall have the
right to have representatives participate in all material meetings and
telephone discussions between representatives of Aventis and applicable
Regulatory Authorities in the Territory outside the United States with respect
to each VEGF Product.

     7.4 Regulatory Communications and Correspondence. The Lead Regulatory
Party shall, within two (2) Business Days, provide to the other Party copies of
any material correspondence received from or submitted to the applicable
Regulatory Authorities pertaining to each VEGF Product (including, without
limitation, any meeting minutes). To the extent a Party is not the Lead
Regulatory Party with respect to a VEGF Product, such Party shall use all
reasonable efforts to ensure that, except in extraordinary circumstances, such
Party will not communicate or correspond with, and will use all reasonable
efforts to facilitate the Lead Regulatory Party as the sole party corresponding
or communicating with, any Regulatory Authority concerning a VEGF Product;
provided, however, that nothing herein shall limit or restrict the right of the
Party which is not such Lead Regulatory Party to communicate with any
Regulatory Authority in connection with its manufacturing facilities or other
operations, unless such communications relate directly to the manufacture,
Development, or Commercialization of such VEGF Product. In furtherance of
this, the Party which is not the Lead Regulatory Party will take reasonable
steps and implement reasonable procedures intended to assure the foregoing.

     7.5 Assistance.

          (a) Each Party shall cooperate with the other Party to provide all
necessary information and reasonable assistance and take all actions reasonably
requested by the other Party that are necessary or desirable to enable the
other Party (i) to comply with any Law applicable to any VEGF Product in the
Territory, and (ii) to submit, obtain, maintain and update Approvals with
respect to each VEGF Product in the Territory.

          (b) Such assistance and actions shall include, among other things, keeping
the other Party informed, commencing within forty-eight (48) hours after
notification of any action by, or notification or other information which it
receives (directly or indirectly) from, any Regulatory Authority, Third Party,
or other Governmental Authority, which (A) raises any material concerns
regarding the safety or efficacy of any VEGF Product, (B) indicates or suggests
a potential material liability for either Party to Third Parties arising in
connection with any VEGF Product, or (C) is reasonably likely to lead to a
recall or market withdrawal of any VEGF Product. Information that shall be
disclosed pursuant to this Section 7.5(b) shall include, but not be limited to:

               (i) governmental or regulatory inspections of manufacturing,
distribution or other related facilities used for any VEGF Product;

45

 

               (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 relating to any VEGF
Product;

               (iii) any communication from Regulatory Authorities or other
Governmental Authorities pertaining to the testing, manufacture, sale,
pricing, reimbursement, promotion or distribution of any VEGF Product
and any other Regulatory Authority or other Governmental Authority
reviews or inquiries relating to any VEGF Product;

               (iv) receipt of a warning letter relating to any VEGF Product;

               (v) an initiation of any Regulatory Authority or other Governmental
Authority investigation, detention, seizure or injunction concerning any
VEGF Product; and

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

     7.6 Pharmacovigilance and Safety Data Exchange.

          (a) Both Parties will cooperate with each other in order to fulfill all
the safety, efficacy and regulatory requirements in all countries of the
Territory in which the VEGF Products are being tested, marketed, distributed,
or developed.

          (b) Without limitation to the foregoing, the Parties shall follow specific
procedures to be agreed upon which shall coordinate the exchange of necessary
safety information to ensure prompt communication of such notifications and
compliance with the reporting obligations to all the respective Regulatory
Authorities as well as in handling product complaints. Both Parties will agree
to implement a separate agreement, which explains the pharmacovigilance
responsibilities and establishes procedures for safety information exchange.
This pharmacovigilance agreement is to be completed within ninety (90) days
after the Effective Date.

     7.7 Regulatory Inspection or Audit. If a Regulatory Authority desires to
conduct an inspection or audit of a Party with regard to a VEGF Product, each
Party agrees to cooperate with the other and the Regulatory Authority during
such inspection or audit, including by allowing, to the extent practicable, a
representative of the other Party to be present during the applicable portions
of such inspection or audit. Following receipt of the inspection or audit
observations of the Regulatory Authority (a copy of which the receiving Party
will immediately provide to the other Party), the Party in receipt of the
observations will prepare any appropriate responses that concern a VEGF
Product, provided that the other Party shall have the right to review and
comment on such responses, and such other Party shall consider in good faith
the comments made by such 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

46

 

response. Without limiting
the foregoing, each Party (and its Third Party subcontractors) shall notify the
other Party within twenty-four (24) hours of receipt of notification from a
Regulatory Authority of the intention of such Regulatory Authority to audit or
inspect facilities being used or proposed to be used for the manufacture of
VEGF Products.

     7.8 Recalls and Other Corrective Actions. Decisions with respect to any
recall, market withdrawal or other corrective action related to any VEGF
Product in the Territory shall be made only upon mutual agreement of the
Parties; 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 applicable Law. The Parties shall cooperate with
respect to any actions taken or public statements made in connection with any
such recall or market withdrawal.

     7.9 Cost of Recalls and Other Corrective Actions. Except as otherwise
provided in this Section 7.9, the Parties will share all costs of a recall,
market withdrawal or other corrective action with respect to any VEGF Product
in the Territory as a Shared Promotion Expense. Notwithstanding the foregoing,
a Party shall bear any and all costs of a recall, market withdrawal or
other corrective action with respect to a VEGF Product in the Territory,
including the COGS for the VEGF Product in question, to the extent the recall,
market withdrawal, or other corrective action is attributable predominantly to
the fault of such Party and results from (a) a negligent or reckless act or
omission or intentional misconduct of such Party (or its Affiliate, agent or
sublicensee), (b) the failure of the Party responsible for manufacturing the
VEGF Product to perform its responsibilities and manufacture the VEGF Product
in compliance with specifications or with applicable Laws, including applicable
Good Manufacturing Practices, or (c) a breach of any Laws or the terms of this
Agreement.

ARTICLE 8

MANUFACTURING AND SUPPLY

     8.1 Supply Agreement. Within ninety (90) days after the Effective Date,
the Parties shall enter into one or more supply agreements (each a “Supply
Agreement”), containing customary terms and conditions with respect to the
forecasting, ordering and delivery of Finished VEGF Products and/or Formulated
Bulk VEGF Products and shall specify that the price for Finished VEGF Products
and Formulated Bulk VEGF Products shall be the Manufacturing Cost. Each Supply
Agreement shall include as an annex thereto, a customary quality agreement
containing terms and conditions regarding quality assurance and Good Practices
with respect to the manufacture of VEGF Trap Products or Formulated Bulk VEGF
Products.

     8.2 Manufacture and Supply of Clinical Supply Requirements of VEGF Trap.
Regeneron shall use Commercially Reasonable Efforts to use its Existing
Facility in accordance with the Manufacturing Plan to provide an adequate and
timely supply of Clinical Supply Requirements of Finished VEGF Trap Product or
Formulated Bulk VEGF Product until the earlier of (a) the date of the First
Commercial Sale of the first VEGF Trap Product, or (b) the date that Aventis is
capable of producing such Clinical Supply Requirements on its own or through a
Third Party manufacturer. Regeneron shall

47

 

supply such Clinical Supply Requirements of the VEGF Trap Product at Regeneron’s Clinical Supply Cost;
provided that if such Clinical Supply Requirements are for a VEGF Trap Product
that is also manufactured by Regeneron for Commercial Supply Requirements, such
Clinical Supply Requirements shall be supplied at the Manufacturing Cost set
forth in Schedule 1.98 for Commercial Supply Requirements.

     8.3 Aventis Manufacturing and Supply Obligations. Aventis shall use
Commercially Reasonable Efforts to provide an adequate and timely supply of
Commercial Supply Requirements and, except as set forth in Section 8.2,
Clinical Supply Requirements of VEGF Products in the Territory for the
Collaboration. Aventis shall supply Clinical Supply Requirements and
Commercial Supply Requirements for the Collaboration at Aventis’ Manufacturing
Cost for each VEGF Product. Aventis may satisfy its requirements under this
Section 8.3 through one of its existing manufacturing facilities, by, at its own expense,
constructing and obtaining all required approvals and validations by Regulatory
Authorities for, a new manufacturing facility, or, with Regeneron’s prior
consent (and consistent with the Collaboration Purpose), either (i) by paying
for the expansion and scale-up of Regeneron’s Existing Facility as contemplated
by the Manufacturing Plan or (ii) through a Third Party manufacturer; provided
that, in each case, such activities are consistent with the Manufacturing Plan
prepared by the Supply Chain Sub-Committee (with input from the JDC) and
approved by the JSC pursuant to Section 8.7. All costs and expenses (including
capital expenditures) required to provide additional manufacturing capacity
(including, if applicable, at the Existing Facility), including without
limitation the related start-up and validation activities contemplated by the
Manufacturing Plan, shall be paid by Aventis, it being understood and agreed
that upon its purchase thereof as contemplated by the Manufacturing Plan,
[*****************].

     8.4 Manufacturing Compliance. Each Party shall be responsible for
manufacturing VEGF Products in accordance with all applicable Laws, including
applicable Good Manufacturing Practices. The Parties will enter into a
separate quality agreements containing terms and provisions customary for that
type of agreement in the pharmaceutical industry. One of the quality
agreements may constitute an annex to the Supply Agreement. Both Parties shall
use Commercially Reasonable Efforts to minimize Manufacturing Cost for each
VEGF Product.

     8.5 Manufacturing Shortfall. Each Party shall be 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 VEGF
Products. Upon such notification, the matter shall be referred to the Supply
Chain Sub-Committee (or the JSC) to determine what, if any alternative supply
source of VEGF Product (an “Alternative Supplier”) should be identified and
established. The goal of the Parties in identifying an Alternative Supplier
will be first to use the internal capacity of Aventis and/or its Affiliates
and/or Regeneron to fill the supply shortfall, such that the manufacturing
Party shall be considered the Alternative Supplier for purposes of this Section
8.5. In the event the Supply Chain Sub-Committee (or JSC) agrees to establish
an Alternative Supplier, each Party shall transfer or license (on a royalty
free basis) Know-How and Patent Rights necessary to transfer production to such
Alternative Supplier in a timely manner and

48

 

provide reasonable assistance to
the Alternative Supplier to effect such transfer. Any increase in COGS and any
other reasonable and direct costs directly associated with the transfer of
production responsibilities to Alternative Suppliers shall be borne exclusively
by the Party responsible for the shortfall. For purposes of the preceding
sentence, a Party shall not be deemed responsible for such shortfall to the
extent such shortfall arises from a material increase in Commercial Supply
Requirements from that in the agreed upon demand forecast that could not
reasonably be anticipated and supplied through the exercise of Commercially
Reasonable Efforts.

     8.6 Distribution. Aventis (or its local Affiliate) shall be responsible
for the distribution of the VEGF Products in countries other than the
Co-Marketing Countries. Each Party will be responsible for its own
distribution of VEGF Products in the Co-Marketing Countries. Aventis will
maintain and manage VEGF Product inventory levels based on a JCC approved risk
assessment and inventory management policy.

     8.7 Manufacturing Plans. The Parties, through the Supply Chain
Sub-Committee, will agree upon the VEGF Product manufacturing plan (the
“Manufacturing Plan”) providing for Regeneron’s manufacture and supply of
Clinical Supply Requirements in accordance with Section 8.2 and Aventis’
manufacture and supply in accordance with Section 8.3. In addition, the
Manufacturing Plan shall reflect the Parties’ intention to use Commercially
Reasonable Efforts to minimize Manufacturing Cost for each VEGF Product. The
Supply Chain Sub-Committee will prepare and update the Manufacturing Plan
coordinating the entire supply chain to support all VEGF Product needs and
coordinate with the Joint Development Committee to prepare associated
regulatory strategy and procedures. The initial Manufacturing Plan is annexed
hereto as Schedule 7. The Parties shall use Commercially Reasonable Efforts to
perform their responsibilities in accordance with the Manufacturing Plans. The
Manufacturing Plan shall include plans for appropriate back-up manufacturing
facilities and inventory levels typically maintained to prevent any
interruption, discontinuity or other impediment to continued supply of VEGF
Products.

     8.8 Co-Marketing Supply. In the event of a Co-Marketing of any VEGF
Product, the Parties will negotiate in good faith a separate Supply Agreement
providing for the supply of such VEGF Product at the agreed upon price and
containing terms and provisions customary for that type of agreement in the
pharmaceutical industry as deemed necessary and/or required and/or advisable by
the Parties. Any such supply agreement shall be considered an Ancillary
Agreement.

     8.9 Manufacturing Changes. Any changes of the manufacturing or quality
testing process or the related sites, for the Finished VEGF Products or
Formulated Bulk VEGF Product, which may have an influence on (i) the quality of
the VEGF Products or on (ii) the regulatory status of the VEGF Products, other
than those required by applicable Law, shall require the prior written approval
of the Parties.

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ARTICLE 9

PERIODIC REPORTS; PAYMENTS

     9.1 Sharing of Collaboration Profits and Losses.

          (a) Recognizing the joint nature of the Collaboration, and the degree of
risk and opportunity contemplated by each of the Parties hereunder, commencing
on the Effective Date and continuing during the Term, the Parties shall share
(i) the Major Market Profit Split in the Major Market Countries (other than any
Co-Marketing Country), and (ii) the Rest of World Profit Split in the Rest of
World Countries, in each case, as described in Schedule 1.

          (b) Commencing on the Effective Date and continuing during the Term,
Aventis shall be responsible for paying one hundred percent (100%) of the total
Development Costs incurred in accordance with the terms of this Agreement and
the applicable Co-Development Budget, by or on behalf of Aventis, Regeneron,
and their respective Affiliates, subject to Aventis’ right to receive
Development Payments (as defined in and calculated in accordance with Schedule
1) during the Term. Regeneron shall be responsible for any development costs
incurred prior to the Effective Date, unless they qualify to be treated as
Development Costs pursuant to Section 5.2.

     9.2 Periodic Reports. Aventis and Regeneron shall each prepare and
deliver to the other Party the periodic reports specified below in this Section
9.2:

          (a) Each Party shall deliver electronically the reports required to be
delivered by it pursuant to Sections 5.3 and 6.4;

          (b) Within twenty (20) days following the end of each month, Aventis shall
deliver electronically to Regeneron a monthly detailed Net Sales report with
monthly and year-to-date sales for each VEGF Product by country in Euro or such
other currency as used by Aventis in its internal reporting systems;

          (c) Within forty-five (45) days following the end of each calendar
quarter, Aventis shall deliver electronically to Regeneron a written report
setting forth, on a country-by-country basis for such quarter: (i) the Net
Sales of each VEGF Product in local currency and, in Euro, (ii) in Major Market
Countries, and any Rest of World Countries where readily available, quantities
sold by dosage form and unit size, (iii) with respect to the United States, an
accounting of the deductions from gross sales permitted by the definition of
Net Sales, and (iv) in Major Market Countries, gross sales of VEGF Products;

          (d) Within forty-five (45) days following the end of each calendar
quarter, each Party shall deliver electronically to the other Party a written
report setting forth in reasonable detail the Development Costs incurred by
such Party in such calendar quarter;

          (e) Within forty-five (45) days following the end of each calendar
quarter, each Party that has incurred any Shared Promotion Expense in
accordance with

50

 

an approved Global Co-Commercialization Plan and/or an approved
Country Co-Commercialization Plan in that calendar quarter shall deliver
electronically to the other Party a written report setting forth in reasonable
detail the Shared Promotion Expense incurred by such Party in such calendar
quarter;

          (f) Within forty-five (45) days following the end of each calendar
quarter, Regeneron shall deliver electronically to Aventis a written report
setting forth on a country-by-country basis Regeneron’s Sales Force Cost and
Regeneron’s Medical Affairs Cost in each Rest of World Country as set forth in
the approved Country Co-Commercialization Plan and Country Co-Commercialization
Budget for such country for such calendar quarter; and

          (g) Within sixty (60) days following the end of each calendar quarter,
Aventis shall deliver electronically to Regeneron a Consolidated Net
Profit/Loss Report in respect of such calendar quarter, combining the
information reported by each Party and showing its calculations in accordance
with Schedule 1 of the amount of any payments to be made by the Parties
hereunder for such quarterly period as contemplated by Section 9.3 and, if
applicable, providing for the netting of such payments.

All reports referred to in this Section 9.2 shall be in such form, format and
level of detail as may be approved by the Joint Finance Sub-Committee.

     9.3 Funds Flow. If Aventis is the Party owing the Quarterly True-Up based
on the calculations in the Consolidated Net Profit/Loss Report, it shall make
such payment to Regeneron within ten (10) days after its delivery to Regeneron
of such Consolidated Net Profit/Loss Report. If Regeneron is the Party owing
the Quarterly True-Up based on the calculations in the Consolidated Net
Profit/Loss Report, it shall make such payment to Aventis within ten (10) days
after its receipt of such Consolidated Net Profit/Loss Report from Aventis.
Notwithstanding the foregoing, no later than fifty-five (55) days after the end
of each calendar quarter, Aventis shall pay Regeneron the amount of royalties
payable under any Existing License or New License to which Regeneron is a party
on account of VEGF Product sales in the Territory.

     9.4 Upfront Payments and Milestone Payments.

          (a) In partial consideration for the funding of development of the VEGF
Products, Aventis shall pay to Regeneron a non-refundable, non-creditable
upfront payment of U.S. $80,000,000 (which shall not be reduced by any
withholding or similar taxes), within three (3) Business Days of the Effective
Date.

          (b) In addition to the other payments contemplated herein, Aventis shall
be obligated to pay the non-refundable, non-creditable milestone payments
listed in Schedule 2 to Regeneron upon the occurrence of the applicable
milestone event. Aventis shall have five (5) Business Days after the
achievement of any such milestone to pay the corresponding amount to Regeneron, in each case, which shall not be
reduced by any withholding or similar taxes.

51

 

     9.5 Revenue and Expenses in Co-Marketing Countries. Subject to the terms
of the final sentence of Section 6.1, each Party shall retain all revenues
accrued by such Party (or its relevant local Affiliate) on its sales of any
VEGF Product in each Co-Marketing Country. Each Party shall be responsible for
its own costs and expenses incurred with respect to any VEGF Product in each
Co-Marketing Country. Within thirty (30) days following the end of each
calendar quarter following the First Commercial Sale in any Co-Marketing
Country, each Party shall provide the JCC with a detailed report of Net Sales
made by the Party or its local Affiliates in Co-Marketing Countries. The
format and timing of such reports shall be as approved by the Joint Finance
Sub-Committee.

     9.6 Invoices and Documentation. The Joint Finance Sub-Committee 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 and
thereunder.

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

     9.8 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 (National Edition) effective for the date on which the payment was due,
[**************](such sum being referred to as the “Default Interest Rate”).

     9.9 Taxes. Except as set forth in Section 9.4, any withholding or other taxes that
either Party or its Affiliates are required by Law to withhold or pay on behalf
of the other Party, with respect to any payments to such other Party hereunder
or the Ancillary Agreements, shall be deducted from such payments and paid to
the appropriate tax authority contemporaneously with the remittance to the
other Party; provided, however, that the withholding Party shall furnish the
other Party with proper evidence of the taxes so paid. Each Party shall
cooperate with the other and furnish the other Party with appropriate documents
to secure application of the most favorable rate of withholding tax under
applicable Law (or exemption from such withholding tax payments, as
applicable).

52

 

     9.10 Adjustments to FTE Rates/Overhead Charge. Notwithstanding anything
herein to the contrary, upon the request of either Party (such request to occur
not more than once every three years for any Major Market Country), the Parties
shall meet to review the accuracy of an applicable FTE rate used herein in any
Major Market Country (e.g., Sales Force FTE Rate, Medical Affairs FTE Rate,
Development FTE Rate, etc.) or Overhead Charge. The Parties agree to share
reasonable supporting documents and materials in connection with an assessment
of the applicable FTE rate(s) and Overhead Charge and to determine in good
faith whether to adjust the rates or charges in such Major Market Countries.

ARTICLE 10

DISPUTE RESOLUTION

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

     10.2 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 shall be resolved pursuant to Article 3 and,
to the extent such matters constitute a Technical Development Matter, Section
10.4, except in each case 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 purposes of this Agreement, the term “Technical Development
Matter” shall mean (i) any matter with respect to the Development of a VEGF
Product involving the determination of any trial design issues, including
without limitation protocols, endpoints and number of patients; provided that a
decision on the matter would not have a material effect on the Development
Costs and (ii) any dispute concerning the JDC’s refusal to approve Phase IIA
Clinical Trials or Phase IIB Clinical Trials proposed by Regeneron pursuant to
Section 2.4.

     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 commencement of the
Term by good faith negotiation and discussion. In the event that the JSC is
unable to resolve any 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, the Parties shall be
free to pursue any rights and remedies available to them at law, in equity or
otherwise.

     10.4 Expert Panel. In the event of a dispute by the Parties concerning a
Technical Development Matter that cannot be resolved by the Executive Officers
pursuant to Section 3.12(b) (other than a Legal Dispute or any dispute
concerning any proposed amendment of the Initial Co-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

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a statement of the issue
forming the basis of the dispute and the position of the moving Party as to the
proper resolution of that issue. 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 and of its position as to
the proper resolution of that issue. Within twenty (20) 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, (ii) is not a director, employee or consultant of,
or otherwise receiving compensation or other payments from such Party, 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 and that,
as a member of the Expert Panel, such individual is able to render an
independent decision. Each Party shall, within the same twenty (20) day
period, provide its designated expert with a list of three (3) additional
experts in the biotechnology industry and the specific matters at issue who
meet the same criteria as described above. Thereafter, the two (2) appointed
experts shall select a third expert from the list of experts provided by the
Parties. Each expert shall agree, prior to his or her appointment, to name
such third expert, and hear the dispute, promptly and render a decision as soon
as practicable thereafter. The experts shall not amend this Agreement, but
shall seek to fashion a remedy consistent with 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.

     10.5 No Waiver. Nothing in this Article 10 shall prohibit either Party
from seeking immediate injunctive or other equitable relief if such Party
reasonably believes that it will suffer irreparable harm from the actions of
the other.

ARTICLE 11

TRADEMARKS AND CORPORATE LOGOS

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

     11.2 Selection of Product Trademarks. The JCC shall select one or more
Product Trademarks (including back-up trademarks) for each VEGF Product for use
with respect to such VEGF Product. Each VEGF Product shall be promoted and
sold in the Co-Commercialization Countries under the applicable Product
Trademark(s) approved by the JCC.

     11.3 Ownership of Product Trademarks. Unless otherwise mutually agreed
between the Parties, (a) Regeneron (or its local Affiliates, as appropriate)
shall own and retain all right, title and interest in and to Product
Trademark(s) for the Regeneron VEGF Products, together with all associated
domain names, trade dress, trade names, and service marks for the Regeneron
VEGF Products in the United States, and all goodwill related thereto (the
“Regeneron Trademarks”), and (b) Aventis (or its local Affiliates, as

54

 

appropriate) shall own and retain all right, title and interest in and to
Product Trademark(s) for the Aventis VEGF Products, together with all
associated domain names, trade names, trade dress, and service marks for the
Aventis VEGF Products throughout the Territory and for Regeneron VEGF Products
in all countries in the Territory other than the United States and all goodwill
related thereto (the “Aventis Trademarks”). In the Co-Marketing Countries, (a)
Aventis shall own and have the exclusive right to use the Product Trademarks
for oncology, (b) Regeneron shall own and have the exclusive right to use the
Product Trademarks for diseases of the eye and (c) for all other Therapeutic
Areas, the JSC shall establish a process for selecting which Party shall own
and retain the rights to the Product Trademark(s) for each such Therapeutic
Area in each of clauses (a), (b) and (c) above, together with all associated
domain names, trade dress, service marks and all goodwill related thereto.

     11.4 Prosecution and Maintenance of Product Trademarks.

          (a) Regeneron will use Commercially Reasonable Efforts to prosecute and
maintain the Regeneron Trademarks for the Regeneron VEGF Products in the United
States. Notwithstanding the foregoing, in the event Regeneron elects not to
prosecute or maintain any Regeneron Trademark in the United States, Aventis
shall have the right to do so on behalf of Regeneron for use with the VEGF
Products during the Term, subject to consultation and cooperation with
Regeneron. The Parties agree that all Out-of-Pocket Costs incurred in
connection with the prosecution and maintenance of Regeneron
Trademarks by Regeneron in the United States during the Term shall be
shared by the Parties as part of Shared Promotion Expenses.

          (b) Aventis will use Commercially Reasonable Efforts to prosecute and
maintain the Aventis Trademarks for the Aventis VEGF Products in the Territory,
and the Regeneron Trademarks for the Regeneron VEGF Products in all countries
in the Territory other than the United States. Notwithstanding the foregoing,
in the event Aventis elects not to prosecute or maintain any Aventis Trademark
in the Territory, or any Regeneron Trademark in any country in the Territory,
Regeneron shall have the right to do so on behalf of Aventis for use with the
VEGF Products during the Term, subject to consultation and cooperation with
Aventis. The Parties agree that all Out-of-Pocket Costs incurred in connection
with the prosecution and maintenance of Aventis Trademarks or the Regeneron
Trademarks by Aventis in the Major Market Countries during the Term shall be
shared by the Parties as part of Shared Promotion Expenses.

     11.5 License to the VEGF Product Trademarks. Each Party hereby grants to
the other Party a license to use its Product Trademark(s) for the VEGF Products
in the Co-Commercialization Countries for the purposes of such Party’s
Co-Commercialization activities pursuant to this Agreement and subject to the
terms and conditions of this Agreement. Each Party’s rights under this Section
11.5 may be sublicensed, but only to its Affiliates and permitted sublicensees
for the purposes of, and subject to the terms and conditions of, this
Agreement. Except as provided in this Agreement, neither Party shall have
rights in or to the other Party’s Product Trademarks or the goodwill pertaining
thereto. Each Party shall utilize the other Party’s Product Trademarks only on
approved Promotional Materials or other approved product-related materials for
the VEGF

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Products for the purposes contemplated herein, and all use by a Party
or its Affiliates or permitted sublicensees of the Product Trademark(s) of the
other Party shall (a) be in accordance with (i) rules established by the JCC
and (ii) quality standards established by the other Party which are reasonably
necessary in order to preserve the validity and enforceability of its Product
Trademark(s) and (b) inure to the sole benefit of the other Party for the
purposes of trademark and trade name ownership, registration, enforcement and
maintenance. Each Party agrees that at no time during the Term will it or any
of its Affiliates attempt to use or register any trademarks, trade dress,
service marks, trade names or domain names confusingly similar to the other
Party’s Product Trademark(s) for the VEGF Products or take any other action
which damages or dilutes the rights to, or goodwill associated with, such
Product Trademarks in the applicable Co-Commercialization Countries. Subject
to Article 19, each Party agrees that upon termination or expiration of the
Term, it will discontinue forthwith all use of the other Party’s Product
Trademark provided that each Party shall have the right to continue to use such
other Party’s Product Trademark for a maximum period of two (2) years
thereafter solely to the extent necessary to exhaust existing inventory of VEGF
Product containing such Product Trademark. 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 assigning any rights in the
trademark, trade dress,
service marks, copyrights and goodwill associated therewith referred to
above in this Section 11.5.

     11.6 Use of Corporate Names. Each Party (through its Affiliates, as
appropriate) shall use Commercially Reasonable Efforts to include the other
Party’s name (or such other Party’s local Affiliate’s name) with equal
prominence on materials exclusively related to each VEGF Product (including,
without limitation, package inserts, packaging, trade packaging, samples, and
all Promotional Materials used or distributed in connection with the applicable
VEGF Product) in the Co-Commercialization Countries, unless to do so would be
prohibited under applicable Laws; provided, however, in the case of
multi-product materials that refer to VEGF Products as well as non-VEGF
Products, the prominence of the other Party’s commensurate with the relative
prominence of the VEGF Product in such materials. Accordingly, each Party
grants to the other (and its Affiliates) the right, free of charge, to use its
name and logo on package inserts, packaging, trade packaging, samples and on
all Promotional Materials used or distributed in connection with the applicable
VEGF Product in the Co-Commercialization Countries during the Term and
thereafter for a maximum period of two (2) 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
VEGF Product and Promotional Materials containing such name or logo.

ARTICLE 12

NEWLY CREATED INVENTIONS

     12.1 Ownership of Newly Created Intellectual Property.

          (a) Each Party shall exclusively own all intellectual property (including,
without limitation, Know-How, Patents and Patent Applications and

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copyrights)
discovered, invented, authored or otherwise created solely by such Party, its
employees, agents and consultants (“Sole Inventions”). Sole Inventions made
solely by Aventis, its employees, agents and consultants are referred to herein
as “Aventis Sole Inventions.” Sole Inventions made solely by Regeneron, its
employees, agents and consultants are referred to herein as “Regeneron Sole
Inventions.” The Parties agree that nothing in this Agreement, and no use by a
Party of the other Party’s Intellectual Property pursuant to this Agreement,
shall vest in a Party any right, title or interest in or to the other Party’s
Intellectual Property, other than the license rights expressly granted
hereunder.

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

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

          (d) To the extent that any right, title or interest in or to any
intellectual property vests in a Party, by operation of Law or otherwise, in a
manner contrary to the agreed upon ownership as set forth in this Agreement,
such Party shall, and hereby does, irrevocably assign 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
and other jointly owned intellectual property created under the Collaboration
is governed by the terms and conditions of this Agreement, and with respect to
use outside the scope of the Collaboration, shall be governed as follows: each
Party’s interest in the Joint Inventions may be sublicensed, and any ownership
rights therein transferred, in whole or in part, by each Party without consent
of the other Party, provided that each Party agrees not to transfer any of its
ownership interest in any of the Joint Inventions without securing the
transferee’s written agreement to be bound by the terms of this Section
12.1(e); provided, further, that nothing in this Article 12 shall relieve a
Party or

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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. Each of the Parties, 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 joint owner, 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 throughout the Territory, and shall confer with
and keep Aventis reasonably informed regarding the status of such activities
through the IPSC. In addition, Regeneron shall have the following obligations
with respect to the filing, prosecution and maintenance of Patent Applications
and Patents included in the Regeneron Patent Rights: (i) Regeneron shall use
Commercially Reasonable Efforts to provide to Aventis review and comment 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 Regeneron and consider in good faith any comment; (ii)
Regeneron shall notify the Aventis prior to the filing of a Patent Application
by Regeneron; (iii) Regeneron shall consult with the Aventis promptly following
the filing of the priority Patent Application to mutually determine in which
countries it shall file convention Patent Applications; (iv) Regeneron shall
provide Aventis promptly with copies of all communications received from or
filed in patent offices with respect to such filings; and (v) Regeneron shall
provide Aventis, a reasonable time prior to taking or failing to take action
that would affect the scope or validity of rights under any Patent Applications
or Patents (including but not limited to substantially narrowing or canceling
any claim without reserving the right to file a continuing or divisional Patent
Application, abandoning any Patent or not filing or perfecting the filing of
any Patent Application in any country), with notice of such proposed action or
inaction so that Aventis has a reasonable opportunity to review and make
comments, and take such actions as may be appropriate in the circumstances. In
the event that Regeneron desires to abandon any Patent included in the
Regeneron Patent Rights, Regeneron shall provide reasonable prior written
notice to Aventis of such intention to abandon (which notice shall, in any
event, be given no later than sixty (60) days prior to the next deadline for
any action that may be taken with respect to such Regeneron Patent with the
applicable patent office) and Aventis shall have the right, but not the
obligation, to assume responsibility for the prosecution and maintenance
thereof in Regeneron’s name, unless, with respect to any such Patent
Applications that are unpublished, Regeneron notifies Aventis that Regeneron
would prefer to maintain the subject matter of such Patent Application as a
trade secret.

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          (b) Aventis shall use Commercially Reasonable Efforts to prepare, file,
prosecute and maintain Patents and Patent Applications (as applicable) included
in the Aventis Patent Rights throughout the Territory, and shall confer with
and keep Regeneron reasonably informed regarding the status of such activities
through the IPSC. In addition, Aventis shall have the following obligations
with respect to the filing, prosecution and maintenance of Patent Applications
and Patents included in the Aventis’ Patent Rights: (i) Aventis shall use
Commercially Reasonable Efforts to provide to Regeneron review and comment 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 Aventis and consider in good faith any comment; (ii)
Aventis shall notify Regeneron prior to the filing of a Patent Application by
Aventis; (iii) Aventis shall consult with Regeneron promptly following the
filing of the priority Patent Application to mutually determine in which
countries it shall file convention Patent Applications; (iv) Regeneron shall
provide Aventis promptly with copies of all
communications received from or filed in patent offices with respect to
such filings; and (v) Aventis shall provide Regeneron a reasonable time prior
to taking or failing to take action that would affect the scope or validity of
rights under any Patent Applications or Patents (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 y has a reasonable
opportunity to review and make comments, and take such actions as may be
appropriate in the circumstances. In the event that Aventis desires to abandon
any Patent included in the Aventis Patent Rights, Aventis shall provide
reasonable prior written notice to Regeneron of such intention to abandon
(which notice shall, in any event, be given no later than sixty (60) days prior
to the next deadline for any action that may be taken with respect to such
Aventis Patent with the applicable patent office) and Regeneron shall have the
right, but not the obligation, to assume responsibility for the prosecution and
maintenance thereof in Aventis’ name, unless, with respect to any such Patent
Applications that are unpublished, Aventis notifies Regeneron that Aventis
would prefer to maintain the subject matter of such Patent Application as a
trade secret.

          (c) 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 to 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)

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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 (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 ninety (90) days of a written request
by the non-Controlling Party to do so, the non-Controlling Party may
assume the Controlling Party’s responsibility for filing, prosecution and
maintenance of any such Joint Patent Right, and will thereafter be deemed the
Controlling Party for purposes hereof. 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, providing a free-of-charge option to assume the prosecution or
maintenance thereof.

          (d) All Out-of-Pocket Costs incurred in the filing, prosecution and
maintenance of any Aventis Patent Rights, Regeneron Patent Rights and Joint
Patent Rights, and any extensions pursuant to 12.2(e), shall be treated as a
Shared Promotion Expense shared between the Parties as set forth herein.

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

     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, Aventis Patent Rights, or Joint Patent Rights in the Territory. The
Parties, through the IPSC, will thereafter consult and cooperate fully to
determine a course of action with respect to any

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such proceeding. Decisions on
whether to initiate such a proceeding and the course of action in such
proceeding, including settlement negotiations and terms, will be made (i) with
respect to Regeneron Patent Rights, by Regeneron in consultation with Aventis
through the IPSC, (ii) with respect to Aventis Patent Rights, by Aventis in
consultation with Regeneron through the IPSC, and (iii) with respect to Joint
Patent Rights, jointly by the Parties through the IPSC.

          (b) All Out-of-Pocket Costs incurred in connection with any interference,
opposition, reissue, or reexamination proceeding relating to the Regeneron
Patent Rights, Aventis Patent Rights and/or Joint Patent Rights shall be
treated as a Shared Promotion Expenses shared between the Parties as set forth
herein.

ARTICLE 13

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 infringement of a Aventis Patent Right, a Regeneron Patent Right, a Joint
Patent Right, trademarks, copyrights or any other intellectual property right
jointly owned or licensed under this Agreement by a Third Party’s activities 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 IPSC to meet and consider
the appropriate course of action with respect to such infringement.

          (b) With respect to any infringement by virtue of a Third Party’s
activities, (i) Regeneron shall have the first right to bring and control any
action or proceeding with respect to infringement of any Regeneron Patent Right
or of any Joint Patent Right that primarily claims VEGF Trap or a Regeneron
VEGF Product (or the making or use thereof), and (ii) Aventis shall have the
first right to bring and control any action or proceeding with respect to
infringement of any Aventis Patent Right or Joint Patent Right other than a
Joint Patent Right that primarily claims VEGF Trap or a Regeneron VEGF Product
(or the making or use thereof) (the Party with the first right being referred
to as the “Lead Litigation Party”); provided, however, that the Parties shall
ensure that there is proper communication and coordination of activities
between the parties through the IPSC. If the Lead Litigation Party fails to
bring any such action or proceeding with respect to infringement of the
applicable Patent Right by a Third Party within sixty (60) days following
notice of the alleged infringement, the non-Lead Litigation Party shall have
the right to bring and control any such action at its own expense (the Party
who controls the litigation to be referred to as the “Litigation Party”). The
non-Litigation Party will provide reasonable assistance to the Litigation Party
in prosecuting any suit, and if required by law, will join in the suit.
Although the Litigation Party has the right to select counsel of its own
choice, it shall first consult with the other Party through the IPSC and
consider in good faith the recommendations of the other Party. The
non-Litigation Party shall have the right to (and if required by law, will)
join

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in any litigation using counsel of its choice at its sole discretion and
expense, subject to Section 13.1(c). The amount of any recovery from any such
infringement suit shall be shared equally by the Parties.

          (c) All Out-of-Pocket Costs (except for the expenses of the non-Litigation
Party’s counsel, if any) incurred in connection with any litigation under
Section 13.1(b) shall be treated as Shared Promotion Expenses shared between
the Parties as set forth herein.

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

     13.3 Third Party Infringement Claims.

          (a) If either Party or its Affiliates (i) shall learn of a claim or
assertion that the manufacture, Development or Commercialization of any VEGF
Product infringes or otherwise violates the intellectual property rights of any
Third Party in the Territory or (ii) learns of any allegations of alleged
Patent invalidity or non-infringement of a Regeneron Patent Right, Aventis
Patent Right or Joint Patent Right or any VEGF Product pursuant to a Paragraph
IV Patent Certification or equivalent certification by a party filing for an
approval of a generic product, then, in each case, such Party shall promptly
notify the other Party in writing of this claim, assertion or certification.
As soon as reasonably practicable after the receipt of such notice, the Parties
shall cause the IPSC to meet and consider the appropriate course of action with
respect to such allegation of infringement.

          (b) If only one Party defends any claimed infringement action commenced by
a Third Party alleging that the manufacture, Development or Commercialization
of any VEGF Product infringes or otherwise violates the intellectual property
rights of such Third Party in the Territory, the other Party and its Affiliates
shall assist and cooperate in any such infringement litigation at the defending
Party’s (or its Affiliates’) reasonable request.

          (c) 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 under this Section 13.3 shall be treated as
Shared Promotion Expenses shared between the Parties as set forth herein.

ARTICLE 14

BOOKS, RECORDS AND INSPECTIONS; AUDITS AND ADJUSTMENTS

     14.1 Books and Records. Each Party shall, and shall cause each of its
respective Affiliates to, keep proper books of record and account in which
full, true and correct entries (in conformity with GAAP) 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

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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
under this Agreement, including, without limitation, the numbers of FTEs and,
in the case of sales representatives responsible for selling VEGF Products, the
information with respect to such sales representatives’ incentive compensation
structure relating to such sales required by Section 6.3(b) to be included in a
Country Co-Commercialization Plan and Country Co-Commercialization Budget, as
applicable, the reports and payments provided under this Agreement and
corresponding provisions of the Ancillary Agreements; 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 the dispute resolution procedures set forth in Section 10.2. If the audited
Party or its Affiliates have underpaid or over billed an amount due under this
Agreement 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 (or
its Affiliate) owing any money hereunder shall pay the same (plus interest
thereon at the Default Interest Rate from the date of such underpayment through
the date of payment of the amount required to be paid pursuant to this Section
14.2(c)) to the Party (or its Affiliate) entitled thereto within thirty (30)
days after receipt of the written results of such audit pursuant to this
Section.

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     14.3 GAAP. Except as otherwise provided herein, all costs and expenses
and other financial determinations with respect to this Agreement shall be
determined in accordance with GAAP as generally and consistently applied.

ARTICLE 15

REPRESENTATIONS AND WARRANTIES

     15.1 Due Organization, Valid Existence and Due Authorization. Each Party
hereto represents and warrants to the other Party, as of the 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 material agreement or arrangement, whether written or oral, by
which it is bound or requirement of applicable Laws or regulations; (d) this
Agreement is its legal, valid and binding obligation, enforceable in accordance
with the terms and conditions hereof (subject to applicable Laws of bankruptcy
and moratorium); (e) such Party is not prohibited by the terms of any
agreement to which it is a party from granting, the licenses granted to the
other under Article 4 hereof; and (f) no broker, finder or investment banker is
entitled to any brokerage, finder’s or other fee in connection with this
Agreement or the transactions contemplated hereby based on arrangements made by
it or on its behalf.

     15.2 Knowledge of Pending or Threatened Litigation. Each Party represents
and warrants to the other Party that, as of the 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
entity or arbitrator that, individually or in the aggregate, could reasonably
be expected to (i) materially impair the ability of such Party to perform any
of its obligations under this Agreement or (ii) 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 Aventis that, as of the Effective Date:

          (a) Regeneron has not previously granted and will not grant any rights
that conflict with the rights and licenses granted herein;

          (b) to Regeneron’s knowledge, [************************], there are no
blocking Patents of a Third Party that would reasonably be expected to prevent
the manufacture, use or sale of VEGF Trap as it is manufactured, used and sold
by Regeneron as of the Effective Date;

          (c) Regeneron is the sole owner of Regeneron’s Patent Applications set
forth on Schedule 15.3(c), to Regeneron’s knowledge, free and clear of all
liens, security interests and other encumbrances (other than unilateral
creditor filings, as to

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which this representation and warranty is made only to
Regeneron’s knowledge), and no
Third Party has any right, title or interest in the Territory with respect
to the Regeneron Patent Applications set forth on Schedule 15.3(c);

          (d) It has no knowledge, [**********], that the making, using or selling
of VEGF Trap as a pharmaceutical product would infringe 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;

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

          (f) Except as otherwise set forth on Schedule 15.3(f), 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 VEGF Trap, any Regeneron facility or, to
Regeneron’s knowledge, any other facility where VEGF Trap is manufactured, and
Regeneron has not received written notice threatening any such claim
investigation, action or other proceeding. During the Term, Regeneron shall
promptly notify Aventis in writing upon learning of any such actual or
threatened claim, investigation, action or proceeding;

          (g) To the knowledge of Regeneron, the development and manufacture of VEGF
Trap has been conducted by Regeneron and its Affiliates and its subcontractors
in compliance in all material respects with all 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 INDs relating to VEGF Trap are not
currently in good standing with, the FDA;

          (h) 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 VEGF Trap (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 VEGF Trap;

          (i) 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;

          (j) Each Existing License is, to Regeneron’s knowledge, in full force and
effect as of the Effective Date. Regeneron has provided, to the extent
contractually permitted, a true and complete copy of each Existing License to
Aventis. 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 Aventis informed of any material development pertaining
thereto that would reasonably be expected to have a material adverse effect on
Aventis’ rights under this Agreement. Regeneron shall not, without the prior
written approval of Aventis (i) amend any provision of an Existing

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License that
would reasonably be expected to have a material adverse effect on Aventis’
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 Aventis’ rights under this Agreement; and

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

     15.4 Additional Aventis Representation and Warranty. Aventis additionally
represents and warrants to Regeneron that as of the Effective Date, to Aventis’
knowledge, Aventis is sponsoring [***************] in the United States.

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

ARTICLE 16

CONFIDENTIALITY

     16.1 Confidential Party Information.

          (a) Each of Aventis and Regeneron acknowledges (subject to Section 16.1(b)
and Article 19) that all Party Information provided by, or discovered,
invented, authorized or otherwise created by the other Party or its respective
Affiliates pursuant to this Agreement is confidential and proprietary to such
other Party or its respective Affiliates, and each of Aventis and Regeneron
agrees to (i) maintain such Party Information and all New Information in
confidence during the Term and for a period of ten (10) years thereafter and
(ii) use such Party Information solely for the purpose of exercising its rights
and performing its obligations hereunder. Each of Aventis and Regeneron
covenants that neither it nor any of its respective Affiliates shall disclose
any
such information to any Third Party except 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.

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          (b) Notwithstanding anything provided above, the restrictions provided in
this Article 16 shall not apply to information that 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 any Person to whom
the receiving party provided such information; (ii) with respect to Party
Information other than New Information is or was already in the possession of
the receiving Party at the time of disclosure by the disclosing Party; (iii) is
disclosed to the receiving Party on an unrestricted basis from a Third Party
not under an obligation of confidentiality to the other Party or any Affiliate
of such other Party with respect to such information; (iv) information that is
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 confidential Party
Information or New Information; or (v) required by Law to be disclosed,
provided that the receiving Party uses reasonable efforts to give the
disclosing Party advance notice of such required disclosure in sufficient time
to enable the disclosing Party to seek confidential treatment for such
information, and provided further that the receiving Party provides all
reasonable cooperation to assist the disclosing Party to protect such
information and limits the disclosure to that information which is required by
Law to be disclosed. Moreover, either Party may use Party Information and New
Information to enforce the terms of this Agreement or any Ancillary Agreement
if it gives reasonable advance notice to the other Party to permit the other
Party a sufficient opportunity to take any measures to ensure confidential
treatment of such information and the disclosing Party shall provide reasonable
cooperation to protect the confidentiality of such information.

          (c) Notwithstanding anything provided above, (i) [*************] any New
Information and/or Regeneron’s Party Information directly related to the
Regeneron VEGF Products (including the making or use thereof) for use in its
manufacture, Development and Commercialization of the Regeneron VEGF Products
[**********]; provided, however, that any such disclosure of information shall
be subject to confidentiality obligations on the part of such licensee
substantially similar to those set forth herein; and (ii) Aventis shall have
the right to disclose to any Aventis licensee of Aventis VEGF Products
[**********] any of Regeneron’s Party Information directly related to the
Aventis VEGF Products, which is requested by such licensee for use in its
Development of the Aventis VEGF Products [**********]; provided, however, that
any such disclosure of information shall be subject to confidentiality
obligations on the part of such licensee substantially similar to those set
forth herein.

          (d) Notwithstanding anything else in this Agreement to the contrary, each
Party hereto (and each employee, representative, or other agent of any Party)
may disclose to any and all Persons, without limitation of any kind, the
Federal income tax treatment and Federal income tax structure of any and all
transaction(s) contemplated herein and all materials of any kind (including
opinions or other tax analyses) that are or
have been provided to any Party (or to any employee, representative, or
other agent of any party) relating to such tax treatment or tax structure,
provided, however, that this authorization of disclosure shall not apply to
restrictions reasonably necessary to comply with securities laws. This
authorization of disclosure is retroactively effective

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immediately upon
commencement of the first discussions regarding the transactions contemplated
herein, and the Parties aver and affirm that this tax disclosure authorization
has been given on a date which is no later than thirty (30) days from the first
day that any Party hereto (or any employee, representative, or other agent of
any party hereto) first made or provided a statement as to the potential tax
consequences that may result from the transactions contemplated hereby.

     16.2 Injunctive Relief. Each Party acknowledges that damages resulting
from breach of this Article 16 would be an inadequate remedy and that,
notwithstanding the provisions of Article 10, in the event of any such
disclosure or any indication of an intent to disclose such information, a Party
(or its Affiliates) owning such Party Information or 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 Aventis
or Regeneron (the “Publishing Party”) desires to disclose any New Information
or such other Party Information which relates to any VEGF Product in scientific
journals, publications or scientific presentations or otherwise, the Publishing
Party shall provide the other Party an advance copy of any proposed publication
or summary of a proposed oral presentation relating to the New Information or
such other Party 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 preserve the New Information or such
other Party Information, and the incorporation of such recommended changes
shall not be unreasonably refused. If such other Party informs the Publishing
Party, within thirty (30) days of receipt of an advance copy of a proposed
publication or summary of a proposed oral presentation, that such publication
in its reasonable judgment should not be published or presented, the Publishing
Party shall delay or prevent such disclosure or publication as proposed by the
other Party. In the case of patentable inventions, the delay shall be
sufficiently long to permit the timely preparation and filing of a patent
application(s) or application(s) for a certificate of invention on the
information involved. Disputes concerning publication shall be resolved by the
JSC.

     16.4 Other Publications. The Parties will mutually agree upon the
contents of a joint press release which shall be issued simultaneously by both
Parties upon the Effective Date. During the Term,
Aventis and Regeneron agree not to (and to ensure that their respective
Affiliates do not do so) issue any other press releases or public announcements
concerning this Agreement or any Ancillary Agreement or any other activities
contemplated thereunder without the prior written consent of the other Party to
the form, timing and content of any such release or announcement, except as
required by a Governmental Authority or applicable Law, and, subject to the
further provisions of this Section 16.4, each Party agrees to provide to the
other Party a copy of any public announcement, as soon as reasonably
practicable (which, except under extraordinary circumstances, shall be at least
five (5) Business Days) prior to its scheduled release;

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provided, however,
that, 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 Ancillary Agreement or any activities
contemplated thereunder which information was included in a press release or
public announcement which was previously approved by the other Party as part of
a press release or other public disclosure concerning this Agreement or which
contains only non-material factual (non-financial) information regarding the
Collaboration (e.g., that the Collaboration is ongoing in accordance with the
terms of this Agreement). Except as otherwise required by applicable Law, the
Party whose press release has been reviewed shall remove any information the
reviewing Party reasonably deems to be inappropriate for disclosure. Neither
Party shall unreasonably withhold or delay its consent to any such press
release or announcement. Except as required by Law, or in connection with the
enforcement of this Agreement, neither Party (or their respective Affiliates)
shall disclose to any Third Party, under any circumstances, any financial terms
of this Agreement that have not been previously disclosed publicly pursuant to
this Article 16 without the prior written consent of the other Party, which
consent shall not be unreasonably withheld or delayed; except for disclosures
to Third Parties that are bound by obligations of confidentiality and nonuse at
least equivalent in scope to those included herein. In furtherance of the
foregoing provisions of this Section 16.4, each Party shall give the other
Party a reasonable opportunity to review all filings of this Agreement and all
filings describing the terms of this Agreement with any Governmental Authority,
including without limitation the United States Securities and Exchange
Commission, prior to submission of such filings, and shall give due
consideration to any reasonable comments by the non-filing Party relating to
such filing, including without limitation the provisions of this Agreement for
which confidential treatment should be sought.

ARTICLE 17

INDEMNITY

     17.1 Indemnity and Insurance.

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

               (i) the negligence, recklessness, bad faith, intentional wrongful
acts or omissions of Aventis or its Affiliates (or, to the extent
permitted under this Agreement, their respective agents, contractors,
distributors, representatives or other persons or entities working on
their behalf), including, without limitation, in connection with the
Development, Co-Commercialization, or manufacture of any VEGF Product,
except to the extent that Damages arise out of the negligence,
recklessness, bad faith or intentional wrongful acts, or omissions
committed by Regeneron or its Affiliates (or, to the extent permitted

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under this Agreement, their respective agents, contractors,
representatives or other persons or entities working on their behalf);
or

               (ii) material breach by Aventis (or conduct or omission by any of
its Affiliates, which if performed or failed to be performed by Aventis
would be a breach by the Aventis) of the terms of, or the
representations and warranties made by it in, this Agreement or any
applicable Ancillary Agreement to which it is a party.

          (b) Regeneron will defend, indemnify and hold harmless Aventis, its
Affiliates and their respective officers, directors, employees and agents
(“Aventis 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 Aventis Indemnitee that is due to or based upon:

               (i) the negligence, recklessness, bad faith, intentional wrongful
acts or omissions of Regeneron or its Affiliates (or, to the extent
permitted under this Agreement, their respective agents, contractors,
distributors, representatives or other persons or entities working on
their behalf), including, without limitation, in connection with the
Development, Commercialization, or manufacture of any VEGF Product,
except to the extent that Damages arise out of the negligence,
recklessness, bad faith or intentional wrongful acts, or omissions
committed by Aventis or its Affiliates (or, to the extent permitted
under this Agreement, their respective agents, contractors,
representatives or other persons or entities working on their behalf);
or

               (ii) material breach by Regeneron (or conduct or omission by any of
its Affiliates, which if performed or failed to be performed by
Regeneron would be a breach by Regeneron) of the terms of, or the
representations and warranties made by it in, this Agreement or any
applicable Ancillary Agreement to which it is a party.

          (c) In the event of any product liability or other Third Party claim in a
Major Market Country for which neither Party is entitled to indemnification
hereunder, the Parties shall treat Damages therefrom as Shared Promotion
Expenses.

          (d) Each of Regeneron and Aventis will use Commercially Reasonable Efforts
to procure and maintain during the Term and for a minimum period of five (5)
years thereafter and for an otherwise longer period as may be required by
applicable Law in countries where the project is conducted, product liability
insurance in an amount not less than Ten Million Dollars ($10,000,000) in the
annual aggregate. Such insurance shall insure against liability on the part of
Regeneron and Aventis and any of its Affiliates, due to injury, disability or
death of any person or persons, or property damage arising from services
performed under this Agreement.

     17.2 Indemnity Procedure.

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

               (i) If the Indemnifying Party has acknowledged in writing to the
Indemnified Party the Indemnifying Party’s responsibility for defending
such claim, the Indemnifying Party shall have the right to defend, at
its sole cost and expense, such claim by all appropriate proceedings,
which proceedings shall be prosecuted diligently by the Indemnifying
Party to a final conclusion or settled at the discretion of the
Indemnifying Party; provided, however, that the Indemnifying Party may
not enter into any compromise or settlement unless (i) such compromise
or settlement includes as an unconditional term thereof, the giving by
each claimant or plaintiff to the Indemnified Party of a release from
all liability in respect of such claim; and (ii) the Indemnified Party
consents to such compromise or settlement, which consent shall not be
withheld or delayed unless such compromise or settlement involves (A)
any admission of legal wrongdoing by the Indemnified Party, (B) any
payment by the Indemnified Party that is not indemnified hereunder or
(C) the imposition of any equitable relief against the Indemnified
Party. If the Indemnifying Party does not elect to assume control of
the defense of a claim or if a good faith and diligent defense is not
being or ceases to be materially conducted by the Indemnifying Party,
the Indemnified Party shall have the right, at the expense of the
Indemnifying Party, upon ten (10) Business Days’ prior written notice to
the Indemnifying Party of its intent to do so, to undertake the defense
of such claim for the account of the Indemnifying Party (with counsel
reasonably selected by the Indemnified Party and approved by the
Indemnifying Party, such approval not unreasonably withheld or delayed),
provided, that the Indemnified Party shall keep the Indemnifying Party
apprised of all material developments with respect to such claim and
promptly provide the Indemnifying Party with copies of all
correspondence and documents exchanged by the Indemnified Party and
the opposing party(ies) to such litigation. The Indemnified Party may
not compromise or settle such litigation without the prior written
consent of the Indemnifying Party, such consent not to be unreasonably
withheld or delayed.

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

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               (iii) 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 Damages.

               (iv) 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 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 18

FORCE MAJEURE

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

ARTICLE 19

TERM AND TERMINATION

     19.1 Term/Expiration of Term.

          (a) The “Term” of this Agreement shall commence on the Effective Date and
end at such time as neither Party, nor either Party’s Affiliates or
sublicensees, is Developing or Commercializing any VEGF Product anywhere in the
Territory (and such cessation of Development and Commercialization activities
is acknowledged by both Parties to be permanent), unless earlier terminated as
provided hereafter.

          (b) Upon expiration of the Term, all licenses and rights with respect to
VEGF Products shall automatically terminate and revert to the granting Party.

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     19.2 Termination Without Cause. Aventis may terminate this Agreement with
respect to the entire Territory for all VEGF Products on twelve (12) months’
prior written notice to Regeneron. Except as otherwise provided below in this
Section 19.2, the Agreement shall continue in full force and effect through the
notice period set forth above (the “Termination Notice Period”). Upon
expiration of the Termination Notice Period, or earlier to the extent provided
below in this Section 19.2, all licenses and rights granted to Aventis
hereunder shall automatically terminate and revert to Regeneron (except to the
extent required by Aventis to fulfill its obligations pursuant to Part A of
Schedule 8, and upon the earlier of such fulfillment or written notice from
Regeneron that it will not require such fulfillment, such licenses and rights,
to the extent not previously terminated, shall automatically terminate and
revert to Regeneron), and the provisions of Part A of Schedule 8 shall apply.
During the Termination Notice Period, to the extent set forth or requested in
one or more written notices from Regeneron to Aventis hereunder (i) such
licenses and rights granted to Aventis shall automatically terminate as of a
date specified in such notice(s) (but not later than the Termination Notice
Period) and (ii) Aventis will promptly take the actions required by Part A of
Schedule 8 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, with as little
disruption as reasonably possible, of the continued Development and/or
Commercialization of such VEGF Product(s). In addition, during the Termination
Notice Period (i) Company shall have no obligation to pay to Regeneron any of
the milestone payments listed on Schedule 2 for any Milestone events that occur
during the Termination Notice Period, except for the $25,000,000 Milestone
payment designated on Schedule 2 as milestone Number “1” if such Milestone
event occurs during such period and (ii) Regeneron shall not without the prior
written consent of the applicable Committee or Sub-Committee propose or
implement any amendment or change to any Co-Development Plan, Co-Development
Budget, Country Co-Commercialization Plan, Country Co-Commercialization
Budget, Global Co-Commercialization Plan or Global Co-Commercialization Budget.

     19.3 Termination For Material Breach. Upon and subject to the terms and
conditions of this Section 19.3, this Agreement shall be terminable by a Party
in its entirety if the other Party commits a material breach of this Agreement.
Such notice of termination shall set forth in reasonable detail the facts
underlying or constituting the alleged breach (and specifically referencing the
provisions of this Agreement alleged to have been breached), and the
termination which is the subject of such notice shall be effective ninety (90)
days after the date such notice is given unless the breaching Party shall have
cured such breach within such ninety (90) day period (or, if such material
breach, by its nature, is a curable breach but such breach is not curable
within such ninety (90) day period, such longer period not to exceed one
hundred eighty (180) days so long as the breaching party is using diligent
efforts to cure such breach, in which event if such breach has not been cured,
such termination shall be effective on the earlier of the expiration of such
one hundred eighty (180) day period or such time as the breaching party ceases
to use diligent efforts to cure such breach). Notwithstanding the foregoing,
in the case of breach of a payment obligation hereunder, the ninety (90) day
period

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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.

     19.4 Termination for Insolvency. Either Party shall have the right to
terminate this Agreement in its entirety if, at any time, (i) the other Party
shall file in any court or agency pursuant to any statute or regulation of any
state or country, a petition in bankruptcy or insolvency or for reorganization
or for an arrangement or for the appointment of a receiver or trustee of the
Party or of its assets, or (ii) if the other Party proposes a written agreement
of composition or extension of its debts, or (iii) if the other Party shall be
served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days
after the filing thereof, or (iv) if the other Party shall propose or be a
party to any dissolution or liquidation, or (v) if the other Party shall make
an assignment for the benefit of creditors. In the event that this Agreement
is terminated or rejected by a Party or its receiver or trustee under
applicable bankruptcy Laws due to such Party’s bankruptcy, then all rights and
licenses granted under or pursuant to this Agreement by such Party to the other
Party are, and shall otherwise be deemed to be, for purposes of Section 365(n)
of the U.S. Bankruptcy Code and any similar Laws in any other country in the
Territory, licenses of rights to “intellectual property” as defined under
Section 101(52) of the U.S. Bankruptcy Code. The Parties agree that all
intellectual property rights licensed hereunder, including, without limitation,
any 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, upon written notice to Aventis, if Aventis shall
have breached Section 20.16 of this Agreement. For the avoidance of doubt,
Regeneron shall not have the right to terminate this Agreement as a result of
an inadvertent breach of Section 20.16(g) arising from informal discussions
covering general corporate or other business matters the purpose of which is
not intended to effectuate or lead to any of the actions referred to in
paragraphs (a) through (e) of Section 20.16.

     19.6 Termination for Breach of Stock Purchase Lock-Up. Notwithstanding
anything to the contrary herein, Regeneron will have the unilateral right to
terminate this Agreement in its entirety, upon written notice to Aventis, if
Aventis shall have materially breached Section 5.3 of the Stock Purchase
Agreement.

     19.7 Effect of Termination/Expiration.

          (a) Except as set forth in Section 19.7(b) below, upon termination of this
Agreement, the provisions of Part A of Schedule 8 shall apply, and except to
the

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extent required by Aventis to fulfill its obligations pursuant to Part A of
Schedule 8 (and upon the earlier of such fulfillment or written notice from
Regeneron that it will not require such fulfillment, such licenses and rights,
to the extent not previously terminated, shall automatically terminate and
revert to Regeneron), (i) all licenses and rights granted by Regeneron to
Aventis hereunder with respect to any terminated country and VEGF Product shall
automatically terminate and revert to Regeneron, and (ii) the licenses from
Aventis and its Affiliates to Regeneron referred to in Part A of Schedule 8
shall come into full force and effect.

          (b) Upon termination of this Agreement by Aventis pursuant to Section 19.3
or 19.4, the provisions of Part B of Schedule 8 shall apply with respect to
Aventis VEGF Products, and except to the extent required by Regeneron to
fulfill its obligations pursuant to Part B of Schedule 8 (and upon the earlier
of such fulfillment or written notice from Aventis that it will not require
such fulfillment, such licenses and rights, to the extent not previously
terminated, shall automatically terminate and revert to Aventis), (i) all
licenses and rights granted by Aventis to Regeneron hereunder with respect to
the Aventis Products and any other Aventis VEGF Products shall automatically
terminate and revert to Aventis, and (ii) the licenses from Regeneron to
Aventis referred to in Part B of Schedule 8 shall come into full force and
effect for the Aventis VEGF Products.

     19.8 Survival of Obligations. Except as otherwise provided in this Article 19, upon expiration or
termination of this Agreement, the rights and obligations of the Parties
hereunder shall terminate to the extent of such expiration or termination, and
this Agreement shall cease to be of further force or effect to the extent of
such expiration or termination, provided that notwithstanding any expiration or
termination of this Agreement: (i) neither Aventis nor Regeneron shall be
relieved of any obligations (including payment obligations) of such Party
arising prior to such expiration or termination, including, without limitation,
the payment of any non-cancelable costs and expenses incurred as part of an
approved Co-Development Plan, Global Co-Commercialization Plan, Joint Country
Commercialization Plan or Manufacturing Plan (even if such costs and expenses
arise following termination or expiration, as the case may be), except that (A)
in the case of termination of this Agreement pursuant to Section 19.2, without
limitation of and subject to Aventis’ continuing obligations under the
provisions referred to in clause (ii) of Section 19.2, Aventis’ other
obligations hereunder shall terminate prior to expiration of the Termination
Notice Period if prior to such expiration Regeneron enters into a collaboration
agreement of substantially similar scope as, and providing for the assumption
and performance by the counterparty thereto of the obligations of Aventis
under, this Agreement and (B) notwithstanding any other term or provision of
this Agreement, upon termination of this Agreement for any reason, Regeneron’s
obligation with respect to Development Payments provided for in Schedule 1
shall automatically terminate; (ii) subject to the provisions of this Article
19 (including 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 2.7, 6.18, 7.2(b), 7.5, 7.6, 7.7, 7.8,
7.9,11.5, 11.6, and Articles 9, 12, 14, 17, 19 (including Schedule 8), and 20
to the extent applicable) which by their nature are

75

 

intended to survive any
such expiration or termination, shall survive and continue to be enforceable;
and (iii) such expiration or termination and this Article 19 shall be without
prejudice to any rights or remedies a party may have for breach of this
Agreement, including, without limitation, any breach of the provisions referred
to in clause (ii) above.

ARTICLE 20

MISCELLANEOUS

     20.1 Governing Law; Submission to Jurisdiction. This Agreement shall be
governed by and construed in accordance with the Laws of the State of New York,
without regard to conflict of laws principles. Each Party hereby irrevocably
and unconditionally consents to the exclusive jurisdiction of the courts of the
State of New York, and the United States District Court for the Southern
District of New York for any action, suit or proceeding arising out of or
relating to this Agreement, waives any objections to such jurisdiction and
venue and agrees not to commence any action, suit or proceeding relating to
this Agreement except in such courts.

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

     20.4 Entire Agreement. This Agreement together with the Ancillary
Agreements to the extent referred to herein 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.

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

     20.6 Headings. 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, further that the Parties shall consult and use all
reasonable efforts to agree upon, and hereby consent to, any valid and
enforceable modification of this Agreement as may be necessary to avoid any
unjust enrichment of either Party and to match the intent of this Agreement as
closely as possible, including the economic benefits and rights contemplated
herein.

     20.8 Registration and Filing of the Agreement. To the extent that a Party
concludes in good faith that it is required to file or register this Agreement
or a notification thereof with any Governmental Authority in accordance with
applicable Laws, such Party may do so subject to the provisions of Section 16.4
above. 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 Aventis or Regeneron without (a) the prior written consent of
Regeneron in the case of any assignment by Aventis or (b) the prior written
consent of Aventis in the case of an assignment by Regeneron, except in each
case (i) to an Affiliate of the assigning Party, provided that the assigning
Party shall remain primarily liable hereunder notwithstanding any such
assignment, or (ii) subject to Section 19.5, 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.

     20.11 Affiliates. Each Party may perform its obligations hereunder
through one or more of its Affiliates, although each Party shall nonetheless be
responsible for the performance of its Affiliates. Neither Party shall permit
any of its Affiliates to commit

77

 

any act (including any act or omission) which
such Party is prohibited hereunder from committing directly.

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

     20.13 Third-Party Beneficiaries. Except as provided below in this Section
20.13, none of the provisions of this Agreement shall be for the benefit of or
enforceable by any Third Party including any creditor of any Party hereto. No
Third Party shall obtain any right under any provision of this Agreement or
shall by reason of any such provision make any claim in respect of any debt,
liability or obligation (or otherwise) against any Party hereto.
Notwithstanding the foregoing, Article 17 is intended to benefit, and to be
enforceable by, in addition to the Parties, the other Regeneron Indemnitees and
Aventis Indemnitees as if they were parties hereto.

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

     20.15 Limitation of Damages. IN NO EVENT SHALL REGENERON OR AVENTIS BE
LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING,
WITHOUT LIMITATION, LOSS OF PROFITS) SUFFERED BY THE OTHER PARTY, REGARDLESS OF
THE THEORY OF LIABILITY (INCLUDING CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY
OR OTHERWISE) AND REGARDLESS OF ANY PRIOR NOTICE OF SUCH DAMAGES, EXCEPT TO THE
EXTENT ANY SUCH DAMAGES ARE PAID TO A THIRD PARTY AS PART OF A THIRD-PARTY
CLAIM WHICH IS COVERED BY THE INDEMNIFICATION OBLIGATIONS IN ARTICLE 17.

     20.16 Standstill Agreement. During the Term and for a period of five (5)
years thereafter, neither Aventis nor any of its Affiliate (for purposes of
this Section 20.16, Aventis, 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

78

 

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

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

provided that the mere voting of any Shares of Then Outstanding Capital Stock
held by the Aventis 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) or (f) 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 (i) the public

79

 

announcement by an Offeror of an Acquisition
Proposal; (ii) the acquisition by an Offeror (other than Dr. Leonard Schleifer
or his Affiliate) 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; or (iii) the issuance by Regeneron to a Third Party
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 for a time period and upon terms
substantially similar to the provisions of this Section 20.17; (iv) a sale of
all or substantially all of the assets of Regeneron (other than to a wholly
owned subsidiary of Regeneron); or (v) 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
(i), (ii) or (iv) above terminates and Regeneron has not made a public
announcement of its intent to solicit or engage in a transaction referred to in
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 employees from the other Party involved in the manufacture,
Development, Co-Promotion or Co-Marketing of any VEGF Product to leave the
employment of the other Party and accept employment with the first Party.
Notwithstanding the foregoing, this prohibition on solicitation does not apply
to actions taken by a Party solely as a result of an employee’s affirmative
response to a general recruitment effort carried through a public solicitation
or general solicitation.

80

 

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

	 	 	 	 	 
	 	 	COMPANY
	 	 	 	 	 
	 	 	
By
	 	/s/ Gerald P.
Belle
	 	 	
	 	

	 	 	 	 	Name: Gerald P. Belle
	 	 	 	 	Title: Authorized
Signatory
	 	 	 	 	 
	 	 	REGENERON PHARMACEUTICALS, INC.
	 	 	 	 	 
	 	 	
By
	 	/s/ Murray
Goldberg
	 	 	
 
	 	

	 	 	 	 	Name: Murray A. Goldberg
	 	 	 	 	Title: Senior Vice
President,

          Finance & Administration

81

 

SCHEDULE 1.101

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

82

 

SCHEDULE 1

Quarterly True-Up

The true-up in a calendar quarter (the “Quarterly True-Up”) shall be equal to
the sum of the Major Market True-Up (as set forth in Part I), plus the Rest of
World True-Up (as set forth in Part II), plus the Regeneron Development
Reimbursement Amount (as set forth in Part III), less the Development Payment
(commencing in the calendar quarter of the First Commercial Sale of a VEGF
Product in any country in the Territory) (as set forth in Part IV). In the
event that the Quarterly True-Up is an amount greater than zero, such amount
will be payable by Aventis to Regeneron in accordance with the terms set forth
in Section 9.3. 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
Aventis in accordance with the terms set forth in Section 9.3. An example of
the Quarterly True-up is shown in Part V.

I. MAJOR MARKET TRUE-UP

The “Major Market True-Up” shall mean the Major Market Profit Split, plus 100%
of Shared Promotion Expenses incurred by Regeneron. The “Major Market Profit
Split” shall mean the product of (x) aggregate Net Sales in Major Market
Countries less aggregate VEGF Product Expenses, and (y) .50. “VEGF Product
Expenses” shall mean the sum of COGS and Shared Promotion Expenses incurred by
both Parties for such calendar quarter. For the avoidance of doubt, the Major
Market Profit Split shall apply independent of the detailing effort provided by
either Party, such that, for example, if Regeneron provided none of the
detailing efforts, it will still be entitled to 50% of the sum of aggregate Net
Sales in the Major Market Countries less aggregate VEGF Product Expenses in
Major Market Countries.

An example of a calculation for a Major Market True-Up would be:

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Aventis	 	Regeneron
	 	 	Aggregate	 	  50%	 	50%
	 	 	
	 	
	 	

	Net Sales in Major Market Countries
	 	 	1000	 	 	 	1000	 	 	 	 	 
	VEGF Product Expenses:
	 	 	 	 	 	 	 	 	 	 	 	 
	• COGS
	 	 	(100	)	 	 	(100	)	 	 	(0	)
	• Shared Promotion Expenses
	 	 	(500	)	 	 	(400	)	 	 	(100	)
	 
	 	 	
	 	 	 	
	 	 	 	
	 
	income or expenses incurred
	 	 	400	 	 	 	500	 	 	 	(100	)
	Major Market Profit-Split
	 	 	 	 	 	 	200	 	 	 	200	 
	Major Market True-Up
	 	 	 	 	 	 	(300	)	 	 	300	 

83

 

II. REST OF WORLD TRUE-UP

The “Rest of World True-Up” shall mean the Rest of World Profit Split plus 100%
of Regeneron’s Sales Force Costs and Regeneron’s Medical Affairs Costs, in each
case as it relates to a Rest of World Country. The “Rest of World Profit Split”
shall mean the product of (x) [*********************], and (z) .50.

An example of a calculation for a Rest of World True-Up would be:

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Aventis	 	Regeneron
	 	 	Aggregate	 	  50%	 	50%
	 	 	
	 	
	 	

	Net Sales in Rest of World Countries
	 	 	20	 	 	 	20	 	 	 	 	 
	Regeneron Sales Force Cost
	 	 	 	 	 	 	 	 	 	 	(2	)
	Regeneron Medical Affairs Cost
	 	 	 	 	 	 	 	 	 	 	(0	)
	[************]
	 	 	[**]	 	 	 	 	 	 	 	 	 
	Rest of World Profit Split
	 	 	10	 	 	 	5	 	 	 	5	 
	 	 	 	
	 	 	 	
	 	 	 	
	 
	Rest of World True-Up
	 	 	 	 	 	 	(7	)	 	 	7	 

III. REGENERON DEVELOPMENT REIMBURSEMENT

The “Regeneron Development Reimbursement Amount” shall mean the aggregate
amount of Development Costs incurred by Regeneron in such calendar quarter.

An example of the Regeneron Development Reimbursement Amount would be: 20

IV. DEVELOPMENT PAYMENT

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

An example of a calculation of Development Payment would be:

	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Aventis	 	Regeneron
	 	 	Aggregate	 	50%	 	50%
	 	 	
	 	
	 	

	[**************]
	 	 	[***]	 	 	 	[***]	 	 	 	[***]	 
	[**************]
	 	 	[***]	 	 	 	 	 	 	 	 	 
	Development Payment
	 	 	(10)	 	 	 	10  	 	 	 	 	 

84

 

V. EXAMPLE OF QUARTERLY TRUE-UP

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

	 	 	 	 	 	 	 
	Major Market True-up	 	
=
	 	 	300	 
	 	 	 	 	 	 	 
	Rest of World True-up	 	
=
	 	 	7	 
	 	 	 	 	 	 	 
	Regeneron Development Reimbursement Amount    =	 	 	20	 
	 	 	 	 	 	 	 
	Development Payment	 	
=
	 	 	(10	)
	 	 	 	 	 	 	 
	Quarterly True-up	 	
=
	 	 	317	 

In this example, Aventis would pay Regeneron 317 in accordance with the terms
set forth in Section 9.3.

85

 

SCHEDULE 2

Milestone Payments

	 	 	 	 	 
	Milestone	 	 	 	 
	
	 	 	 	 
	1	 	
US $25,000,000
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]
	 	 	 	 	 
	[***]	 	
[*******]
	 	[********************]

86

 

For purposes of clarification, each of the foregoing milestone payments shall
be made only once and only upon the first occurrence of each milestone,
regardless of the number of VEGF Products or occurrences of each milestone for
VEGF Products [*********************]. For purposes of further clarification,
if one Marketing Approval in a Major Market Country covers two or more
milestone payments, both (or all) of the applicable milestone payments shall be
made. For purposes of clarification and as an example, only one milestone
would be payable in the circumstance where [****************].

87

 

SCHEDULE 3

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

88

 

SCHEDULE 5

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

89

 

SCHEDULE 7

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

90

 

SCHEDULE 8

Transition Arrangements

PART A of Schedule 8

**As used in this Part A of Schedule 8, the term “VEGF Products” shall exclude
Aventis VEGF Products if the Agreement is effectively terminated by Aventis
pursuant to Section 19.3.

     1.     Aventis 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 Party Information or New Information directly
relating to the VEGF Products , and shall immediately cease, and cause its
Affiliates and sublicensees to cease, all further use of any such Party
Information or New Information with respect to such VEGF Products. In addition,
at Regeneron’s request, Aventis shall collect and transfer to Regeneron any
remaining inventory of Promotional Materials, product samples, and VEGF Product
inventory. Notwithstanding the foregoing in this Part A of Schedule 8, Aventis
may retain copies of any Party Information or New information to the extent
required by Law, as well as retain one (1) copy of such information solely for
legal archive purposes. Regeneron shall be entitled to use and disclose any
such information (including any such Party Information and/or New Information)
in connection with the manufacture, Development or Commercialization of VEGF
Products

     2.     Aventis shall use Commercially Reasonable Efforts to provide all
cooperation and assistance reasonably requested by Regeneron to enable
Regeneron (or its nominee) to assume with as little disruption as reasonably
possible, the continued Development and/or Commercialization of the VEGF
Products. Such cooperation and assistance shall be provided in a prompt and
timely manner (having regard to the nature of the cooperation or assistance
requested) and shall include, without limitation, the following:

          (a) Regeneron shall have a fully paid-up and royalty-free exclusive
license (which shall include the right to grant sublicenses) from Aventis under
Aventis Patent Rights and Aventis Know-How existing at the effective date of
termination that are used to Develop, make, have made, use, import, offer to
sell and sell the VEGF Products as of the effective date of termination for use
in connection with such activities.

          (b) Aventis shall transfer and assign to Regeneron (or its nominee) all
Approvals and regulatory filings (including Registration Filings) made or
obtained by Aventis or its Affiliates or any of its sublicensees to the extent
specifically relating to the VEGF Products (other than Approvals for Aventis
manufacturing facilities). In addition, at Regeneron’s request, Aventis shall
take all actions to revoke any appointment as Regeneron’s exclusive agent in
the United States, including writing a letter to the applicable Governmental
Authorities in the United States to revoke such appointment.

91

 

          (c) Aventis shall assign and transfer to Regeneron (or its nominee)
Aventis’ entire right, title and interest in and to all Product Trademarks to
the extent specifically relating to the VEGF Products and to any domain names
containing such Product Trademarks; provided that nothing herein is intended to
convey any rights in or to Aventis’ corporate name and logos or any trade
names.

          (d) Aventis shall provide to Regeneron (or its nominee) a copy (or
originals to the extent required by any Regulatory Authority in connection with
the manufacture, Development or Commercialization of the VEGF Products in the
Territory of all information (including any Party Information and/or New
Information)) in its possession or under its control to the extent directly
relating to any VEGF Products, including, without limitation, all information
contained in the regulatory and/or safety databases, all in the format then
currently maintained by Aventis, or such other format as may be reasonably
requested by Regeneron.

          (e) [********************]

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

          (g) Without limitation of Aventis’ other obligations under this Part A of
Schedule 8, Aventis will take the actions required by subparagraph (g)(i) below
to the extent it is responsible for supplying Commercial Requirements of such
VEGF Product in such country pursuant to Article 8.

               (i) Aventis will supply Regeneron with Clinical Supply Requirements and/or
Commercial Requirements of finished and packaged VEGF Products at the same
price, and on such other terms and conditions on which Aventis was supplying,
or in the absence of termination, would have been required to supply such
finished and packaged VEGF Products, through the second anniversary of the
effective date of termination of this Agreement or such shorter period if
Regeneron notifies Aventis that it is able to manufacture or have manufactured
VEGF Products on comparable financial terms.

          (h) [**************************] Regeneron shall have the right to acquire
the Aventis Equipment on ninety days prior notice for a purchase price equal to
the book value of the Aventis Equipment on the acquisition date. Such right
shall be exercisable prior to the effective date of termination or, if
paragraph (g)(i) of this Schedule 8 is applicable, prior to the earlier of (i)
the second anniversary of such effective date or (ii) the date Aventis’
completes its post-termination supply obligations. If Regeneron notifies
Aventis that it will not exercise this purchase option, or fails to timely
deliver a notice of its exercise of its right to purchase the Aventis
Equipment, then Aventis shall have a reasonable period of time to remove the
Aventis Equipment from Regeneron’s facility and only upon reasonable advance
notice. If the Aventis Equipment is used in connection with such
post-termination supply obligations, Aventis shall not remove the Aventis
Equipment until the completion of Aventis’ post-termination supply obligations.
Regeneron shall provide Aventis with reasonable access to its manufacturing
facility to remove the Aventis Equipment pursuant to this paragraph (h) and,
following

92

 

the removal, Aventis shall restore the space in the facility used to house
the Aventis Equipment to its pre-installation condition.

     3.     Without limitation of the generality of the foregoing, the Parties
shall use Commercially Reasonable Efforts to complete the transition of the
Co-Development and Co-Commercialization of the VEGF Products hereunder to
Regeneron (or its sublicensee or third party designee) as soon as is reasonably
possible.

     4.     For the avoidance of doubt, Regeneron shall not be required to provide
Aventis any consideration in exchange for the licenses or other rights granted
to it pursuant to the provisions of this Part A of Schedule 8; provided,
however, that Regeneron shall be solely responsible for paying any royalties,
fees or other consideration that Aventis may be obligated to pay to a Third
Party in respect of any such transfer or sublicense to Regeneron of such
licenses or other rights; and provided, further, that if Aventis continues to
manufacture the VEGF Products in such terminated country pursuant to paragraph
(g) above, Regeneron shall purchase such products at the price, and on such
other terms and conditions specified therein.

PART B of Schedule 8

     1.     Regeneron shall promptly collect and return, and cause its Affiliates
and sublicensees to collect and return, to Aventis or, at Aventis’ request,
destroy, all documents containing Party Information or New Information directly
relating to any Aventis VEGF Product in the terminated country, and shall
immediately cease, and cause its Affiliates and sublicensees to cease, all
further use of any such Party Information or New Information with respect to
such Aventis VEGF Products. Notwithstanding the foregoing in this Part B of
Schedule 8, Regeneron may retain copies of any such information to the extent
required by Law, as well as retain one (1) copy of such information solely for
legal archive purposes. Aventis shall be entitled to use and disclose any such
information (including any such Party Information and/or New Information) in
connection with the manufacture, Development, Commercialization, production of
Aventis VEGF Products.

     2.     Regeneron shall use Commercially Reasonable Efforts to provide all
cooperation and assistance reasonably requested by Aventis to enable Aventis
(or its nominee) to assume with as little disruption as reasonably possible,
the continued Development and/or Commercialization of the Aventis VEGF
Products. Such cooperation and assistance shall be provided in a prompt and
timely manner (having regard to the nature of the cooperation or assistance
requested) and shall include, without limitation, the following:

          (a) Aventis shall have a fully paid-up and royalty-free exclusive license
(which shall include the right to grant sublicenses) from Regeneron under
Regeneron Patent Rights and Regeneron Know-How existing at the effective date
of termination that are used to Develop, make, have made, use, import, offer to
sell and sell the terminated Aventis VEGF Products as of the effective date of
termination for use in connection with such activities.

93

 

          (b) Regeneron shall transfer and assign to Aventis (or its nominee) all
Approvals and regulatory filings (including Registration Filings) made or
obtained by Aventis or its Affiliates or any of its sublicensees to the extent
relating to the terminated Aventis VEGF Products (other than Approvals for
Regeneron manufacturing facilities).

          (c) Regeneron shall assign and transfer to Aventis (or its nominee)
Regeneron’s entire right, title and interest in and to all Product Trademarks
to the extent relating to the Aventis VEGF Products and to any domain names
containing such Product Trademarks; provided that nothing herein is intended to
convey any rights in or to Regeneron’s corporate name and logos or any trade
names.

          (d) Regeneron shall provide to Aventis (or its nominee) a copy (or
originals to the extent required by any Regulatory Authority in connection with
the manufacture, Development or Commercialization of the Aventis VEGF Products
of all information (including any Party Information and/or New Information) in
its possession or under its control to the extent directly relating to Aventis
VEGF Products, 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 Aventis.

          (e) [****************************]

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

          (g) Without limitation of Regeneron’s other obligations under this Part B
of Schedule 8, Regeneron will take the actions required by subparagraph (g)(i)
below to the extent it is responsible for supplying Clinical Supply
Requirements of such Aventis VEGF Product in such country pursuant to Article
8.

               (i) Regeneron will supply Aventis with Clinical Supply Requirements of
finished and packaged terminated Aventis VEGF Product 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 finished and
packaged Aventis VEGF through the second anniversary of the effective date of
termination of this Agreement or such shorter period if Aventis is able to
manufacture or have manufactured its Clinical Supply Requirements.

     3.     Without limitation of the generality of the foregoing, the Parties
shall use Commercially Reasonable Efforts to complete the transition of the
Co-Development and Co-Commercialization of the Aventis VEGF Product hereunder
to Aventis (or its sublicensee or third party designee) as soon as is
reasonably possible.

     4.     For the avoidance of doubt, except as set forth in paragraph 2(a)
above, Aventis 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 Part B of Schedule 8; provided, however, that Aventis 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 Aventis of such licenses or other rights.

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SCHEDULE 9

Notices

	 	 	 
	(a)	 	
If to Aventis:
	 	 	
200 Crossing Boulevard
	 	 	
Bridgewater, New Jersey 08807
	 	 	
U.S.A
	 	 	
Attention: Vice President, Legal Corporate Development
	 	 	 
	 	 	
With a copy to:
	 	 	 
	 	 	
Morgan, Lewis, & Bockius, LLP
	 	 	
502 Carnegie Center
	 	 	
Princeton, New Jersey 08540
	 	 	
Attention: Randall B. Sunberg
	 	 	 
	(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

95

 

SCHEDULE 15.3(c)

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

96

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