Exhibit 10.4

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT, MARKED BY BRACKETS, WERE OMITTED
BECAUSE THOSE PORTIONS ARE NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL TO
THE COMPANY IF PUBLICLY DISCLOSED.

PRALUENT CROSS License &
COMMERCIALIZATION AGREEMENT

By and Between

SANOFI BIOTECHNOLOGY SAS

and

REGENERON PHARMACEUTICALS, INC.

Dated as of April 5, 2020

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TABLE OF CONTENTS

ARTICLE 1 DEFINITIONS
ARTICLE 2 LICENSE GRANTS; LIMITED ASSET TRANSFER; TRANSITION COSTS
2.1 Regeneron License Grants
2.2 Sanofi License Grants
2.3 Sublicensing and Subcontracting
2.4 Limitations
2.5 Retained Rights
2.6 Limited Asset Transfer
2.7 Transition Costs
2.8 Certain Contract Services
ARTICLE 3 ALLIANCE MANAGEMENT AND JOINT PRALUENT COMMITTEE
3.1 Alliance Management
3.2 Joint Praluent Committee
3.3 Composition; Meetings; Disbandment; Limitations on Authority
3.4 Cooperation Generally
ARTICLE 4 DEVELOPMENT
4.1 Development of Praluent Products
4.2 Global Clinical Trials
4.3 Other Existing Trials
4.4 Supply for Certain Investigator-Initiated Studies
4.5 Development Records
4.6 Human Biological Materials
4.7 Bioanalytical Testing of Sanofi Samples
4.8 Clinical Trial Updates and Notices
ARTICLE 5 COMMERCIALIZATION
5.1 Commercialization of Praluent Products
5.2 Booking of Sales and Praluent Product Distribution
5.3 Commercialization Updates
5.4 Medical and Consumer Inquiries
5.5 Market Exclusivity Extensions
5.6 Promotional Materials
5.7 Market Access; Pricing Approvals; Re-Sale Price
5.8 Cross-Territory Sales
ARTICLE 6 REGULATORY AFFAIRS
6.1 Ownership of Approvals and Regulatory Filings
6.2 Rights of Reference; Sanofi ROR Authorizations; DAI Design History File;
Separate INDs
6.3 Regulatory Activities
6.4 Pharmacovigilance and Safety Data Exchange

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6.5 Regulatory Inspection or Audit
6.6 Recalls and Other Corrective Actions
ARTICLE 7 TECHNOLOGY TRANSFER - MANUFACTURING AND SUPPLY
7.1 Manufacturing Generally
7.2 [* * *]
7.3 Drug Substance Tech Transfer Plan
7.4 Technology Transfer Costs
7.5 Praluent Supply Agreements
7.6 Back-up Supply
7.7 Regeneron Cell Media
7.8 Cell Banks
7.9 Manufacturing Transition Team
ARTICLE 8 PAYMENTS; BOOKS & RECORDS; AUDITS
8.1 Royalties to Regeneron
8.2 No Royalty to Sanofi
8.3 Reporting
8.4 Royalty Payments
8.5 Transferred Inventory
8.6 Allocation of Sales Deduction Costs
8.7 Reimbursement
8.8 Payment Method and Currency
8.9 Late Payments
8.10 Taxes
8.11 Sanofi Records; Audits by Regeneron
8.12 Regeneron Records; Audits by Sanofi
ARTICLE 9 TRADEMARKS, COPYRIGHTS, CORPORATE LOGOS AND DOMAIN NAMES
9.1 Ownership
9.2 Prosecution, Maintenance, Enforcement, and Defense of Trademarks
9.3 Use of Trademarks and Domain Names
9.4 Use of Corporate Names and Logos
ARTICLE 10 INTELLECTUAL PROPERTY
10.1 Ownership of Intellectual Property
10.2 Prosecution and Maintenance of Patents
10.3 Interference, Opposition and Reissue
10.4 Background Patents
ARTICLE 11 PATENT LITIGATION
11.1 Enforcement of Patents
11.2 Patent Marking
11.3 Third Party Infringement Claims
11.4 Invalidity or Unenforceability Defenses or Actions

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11.5 Interference, Opposition and Reissue of Third Party Patents
11.6 Transfer of Responsibilities
ARTICLE 12 REPRESENTATIONS AND WARRANTIES
12.1 Due Organization, Valid Existence and Due Authorization
12.2 Additional Representations and Warranties of the Parties
12.3 Disclaimer of Warranties
12.4 Mutual Covenants
ARTICLE 13 CONFIDENTIALITY
13.1 Confidential Information
13.2 Exclusions
13.3 Permitted Disclosures and Uses
13.4 Injunctive Relief
13.5 Publication
13.6 Other Publications
ARTICLE 14 INDEMNITY
14.1 Indemnity and Insurance
14.2 Indemnity Procedure
ARTICLE 15 FORCE MAJEURE
ARTICLE 16 TERM AND TERMINATION
16.1 Term
16.2 Termination of Licenses and Certain Contractual Restrictions
16.3 Other Effects of Termination
ARTICLE 17 DISPUTE RESOLUTION
17.1 Resolution of Disputes
17.2 Governing Law; Submission to Jurisdiction
ARTICLE 18 MISCELLANEOUS
18.1 Compliance With Law
18.2 Further Assurances and Transaction Approvals
18.3 Waiver
18.4 Notices
18.5 Entire Agreement
18.6 Amendments
18.7 Headings
18.8 Severability
18.9 Registration and Filing of the Agreement
18.10 Assignment
18.11 Successors and Assigns
18.12 Affiliates
18.13 Counterparts

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18.14 No Third Party Beneficiaries
18.15 Relationship of the Parties
18.16 Limitation of Damages
18.17 Rejection of Agreement in Bankruptcy
18.18 Construction.

SCHEDULES

Schedule 1.57 Global Trial Costs
Schedule 1.72 Joint Patents
Schedule 1.135 Regeneron Core Patents
Schedule 1.156 Sanofi Core Patents
Schedule 1.180 Transferred Approvals
Schedule 1.182 Transfer Product Contracts
Schedule 1.183 Transferred Product Domain Names
Schedule 1.184 Transferred Product Records
Schedule 1.185 Transferred Product Trademarks
Schedule 2.3(c) Approved Contract Manufacturers
Schedule 4.2(a) Global Clinical Trials
Schedule 4.3 Certain Other Existing Trials
Schedule 4.4 Certain Investigator-Initiated Studies
Schedule 4.7 Assay Services
Schedule 7.2(a) [* * *]
Schedule 7.3(a) Drug Substance Tech Transfer Plan
Schedule 8.4 Royalty Invoicing Directions
Schedule 8.5 Transferred Inventory Prices
Schedule 11.5(a) Existing Sole Oppositions
Schedule 11.5(b) Existing European Oppositions
Schedule 12.2(c) Pending or Threatened Litigation or Adverse Agreements
Schedule 18.4 Notice Addresses

EXHIBITS

Exhibit 6.4 Form of SDEA

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Praluent CROSS LICENSE &
commercialization AGREEMENT

THIS PRALUENT CROSS LICENSE & COMMERCIALIZATION AGREEMENT (this “Agreement”),
dated as of April 5, 2020 (the “Execution Date”), and effective as of April 1,
2020 (the “Transition Date”), by and between SANOFI BIOTECHNOLOGY SAS, a société
par actions simplifiée organized under the laws of France and having a principal
place of business at 54 rue La Boétie, 75008 Paris, France (“Sanofi”), 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 Sanofi and Regeneron
referred to herein individually as a “Party” and collectively as the “Parties”).
WHEREAS, Regeneron and Sanofi (as successor in interest to Aventis
Pharmaceuticals Inc. and Sanofi-Aventis Amerique Du Nord) are parties to an
Amended and Restated License and Collaboration Agreement dated as of November
10, 2009, as amended as of May 1, 2013, July 1, 2015, and the date hereof (the
“LCA”) for the Development, Manufacture and Commercialization of certain
Licensed Products (as such term is defined therein), including the antibody
Praluent® (alirocumab); and
WHEREAS, pursuant to the terms and conditions of an amendment to the LCA of same
date as the Execution Date (the “LCA Amendment”), the Parties have agreed to
remove, effective as of the Transition Date (as defined below), the Praluent
Products (as defined below) from the scope of the LCA and desire to have the
Development, Manufacture and Commercialization thereof be governed by the terms
and conditions of this Agreement.
NOW, THEREFORE, in consideration of the following mutual promises and
obligations, and for other good and valuable consideration the adequacy and
sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
Capitalized terms used in this Agreement, whether used in the singular or
plural, except as expressly set forth herein, shall have the meanings set forth
below:
1.1 “Accounting Standards” shall mean, GAAP with respect to Regeneron or
IAS/IFRS with respect to Sanofi, as generally and consistently applied
throughout the applicable Party’s organization.
1.2 “Acting Party” shall have the meaning set forth in Section 11.5(a).
1.3 “Affiliate” shall mean, with respect to any Person, any other Person that
controls, is controlled by or is under common control with such first Person. A
Person shall be deemed to control another Person if such first Person possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such first Person, whether through the ownership of
voting
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securities, by contract or otherwise. Without limiting the generality of the
foregoing, a Person shall be deemed to control another Person if any of the
following conditions is met: (a) in the case of corporate entities, direct or
indirect ownership of at least fifty percent (50%) of the stock or shares having
the right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with the power to direct the management and
policies of such non-corporate entities. The Parties acknowledge that in the
case of certain entities organized under the laws of certain countries outside
of the United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in such case
such lower percentage shall be substituted in the preceding sentence, provided
that such foreign investor has the power to direct the management and policies
of such entity. For purposes of this Agreement, in no event shall Sanofi or any
of its Affiliates be deemed Affiliates of Regeneron or any of its Affiliates nor
shall Regeneron or any of its Affiliates be deemed Affiliates of Sanofi or any
of its Affiliates.
1.4 “Agreement” shall have the meaning set forth in the introductory paragraph
and shall include all Schedules and Exhibits attached hereto.
1.5 “Alliance Manager” shall have the meaning set forth in Section 3.1.
1.6 [* * *].
1.7 “Ancillary Agreements” shall mean the Praluent Supply Agreements, the
Praluent Transition Services Agreement, the Praluent Pharmacovigilance
Transition Services Agreement, the Praluent Services Agreements, the Praluent
Bill of Sale, the Praluent Domain Name Assignment and the Praluent Trademark
Assignment.
1.8 “Ancillary Services Agreements” shall mean the Praluent Supply Agreements,
the Praluent Transition Services Agreement, the Praluent Pharmacovigilance
Transition Services Agreement and the Praluent Services Agreements.
1.9 “Approval” shall mean any approval, registration, license or authorization
from any Regulatory Authority required for the testing, Manufacture,
Development, Commercialization, sale, storage or transport of, or expanded
labeling for, a Praluent Product in any country, and shall include an approval,
registration, license or authorization granted in connection with any IND, BLA
or equivalent application in any country.
1.10 “Assay Services” shall have the meaning set forth in Section 4.7.
1.11 “Back-Up Request” shall have the meaning set forth in Section 7.6.
1.12 “BLA” shall mean a biologics license application filed with respect to a
Praluent Product, as described in the FDA regulations, including all amendments
and supplements to the application.
1.13 “Breaching Party” shall have the meaning set forth in Section 16.2.
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1.14 “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.
1.15 “Calendar Quarter” shall mean each successive period of three (3) calendar
months commencing on January 1, April 1, July 1 and October 1.
1.16 “Calendar Year” shall mean each successive period of twelve (12) calendar
months commencing on January 1, except that the first Calendar Year shall
commence on the Transition Date and shall end on December 31, 2020.
1.17 “CMC” shall mean chemistry, manufacturing and control.
1.18 “Code” shall mean the U.S. Internal Revenue Code of 1986, as amended.
1.19 “Combination Product” shall have the meaning set forth in the definition of
“Net Sales”.
1.20 “Commercialize” or “Commercialization” shall mean any and all activities
directed to marketing, promoting, detailing, distributing, importing, offering
for sale, having sold or selling any Praluent Product or biosimilar thereof (as
the case may be), including obtaining and maintaining NDCs and Pricing Approvals
therefor.
1.21 “Control” shall mean, with respect to any item of Know-How, material,
regulatory documentation, Patents or other intellectual property right,
possession of the right, whether directly or indirectly and whether by
ownership, license (other than by operation of a license or other rights granted
by one Party to the other Party hereunder) or otherwise, to assign, or grant a
license, sublicense, right of reference or other right to or under such
Know-How, material, regulatory documentation, Patents or other intellectual
property right as provided for herein without violating the terms of any
agreement with any Third Party.
1.22 “Controlling Party” shall have the meaning set forth in Section 11.3(b).
1.23 “Copyright” shall mean all copyrights and all rights in any copyrightable
works, in all forms and media, including any copyrightable elements in any html
and web content, and any copyright registrations or applications therefor and
all extensions, restorations, reversions and renewals of any of the foregoing.
1.24 “Cover”, “Covered” or “Covering” shall mean, with respect to an invention
or activity and the relevant Patent, that, but for a license granted under such
Patent or ownership of such Patent, the practice of such invention or the
conduct of such activity would infringe an issued claim in such Patent or, in
the case of a Patent that is a patent application, would infringe a pending
claim in such patent application if such patent application were to issue as a
patent.
1.25 “Damages” shall have the meaning set forth in Section 14.1(a).
1.26 “Default Interest Rate” shall have the meaning set forth in Section 8.9.
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1.27 “Defending Party” shall have the meaning set forth in Section 11.4(b).
1.28 “Develop” or “Development” shall mean activities performed by or on behalf
of either Party relating to research, pre-clinical drug development or clinical
drug development with respect to any Praluent Product or biosimilar thereof (as
the case may be), including test method development and stability testing, assay
development, toxicology, pharmacology, formulation, quality assurance/quality
control development, technology transfer, statistical analysis, process
development and scale-up, pharmacokinetic studies, data collection and
management, clinical studies (including research to design clinical studies),
regulatory affairs, project management, drug safety surveillance activities
related to clinical studies, the preparation and submission of Regulatory
Filings, and any other research and development activities, including the
discovery of biomarkers and activities supporting new formulations, delivery
technologies or new indications.
1.29 “Directing Party” shall have the meaning set forth in Section 11.5(a).
1.30 “Discovery Agreement” shall mean the Amended and Restated Discovery and
Preclinical Development Agreement, between Sanofi, as successor-in-interest to
Aventis Pharmaceuticals, Inc., and Regeneron Pharmaceuticals, Inc., dated as of
November 10, 2009, as amended as of May 1, 2013 and July 1, 2015.
1.31 “Domain Name” shall mean any domain names (including both gTLDs and
ccTLDs), URLs and social media names, tags or handles or similar identifiers.
1.32 “Drug Substance Tech Transfer Plan” shall have the meaning set forth in
Section 7.3(a).
1.33 “EMA” shall mean the European Medicines Agency or any successor agency
thereto.
1.34 “Enforcing Party” shall have the meaning set forth in Section 11.1(b).
1.35 “Europe” means the countries comprising the European Economic Area as of
the Transition Date.
1.36 “Execution Date” shall have the meaning set forth in the introductory
paragraph.
1.37 “Executive Officers” shall mean the Chief Executive Officer of Regeneron
and the Chief Executive Officer of Sanofi, or their respective designees with
equivalent decision-making authority with respect to the matters under this
Agreement.
1.38 “Existing European Opposition” shall have the meaning set forth in Section
11.5(b).
1.39 “Existing Indication” shall mean, with respect to an Existing Praluent
Product, any indication and therapeutic regimen (i.e., standalone therapy or use
with one (1) or more other products) for such indication for which such Existing
Praluent Product (a) has received Marketing Approval as of the Transition Date
or (b) was being, or has been, clinically Developed under the LCA as of the
Transition Date, including under any Existing Trials.
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1.40 “Existing Joint Know-How” shall mean (a) any and all Know-How existing as
of the Transition Date that arose from the Parties’ and their Affiliates’
performance under the LCA, to the extent specifically related to the Praluent
Compound or any Praluent Product, excluding Regeneron Manufacturing Know-How and
Sanofi Manufacturing Know-How and (b) Existing Trials Information whether
created before or after the Transition Date.
1.41 “Existing Praluent Product” shall mean the Praluent Compound or a Praluent
Product (including any delivery devices, e.g., an autoinjector), in either case,
(a) that has received Marketing Approval as of the Transition Date or (b) that
was being, or has been, clinically Developed (or, with respect to such delivery
devices, Developed) under the LCA as of the Transition Date, including under the
Existing Trials.
1.42 “Existing Sole Oppositions” shall have the meaning set forth in Section
11.5(a).
1.43 “Existing Trials” shall mean any clinical trial that was initiated under
the LCA prior to the Transition Date in respect of the Praluent Products,
including investigator-initiated clinical trials. For clarity, the Existing
Trials include the Global Clinical Trials and the Other Existing Trials.
1.44 “Existing Trials Information” shall mean any and all ideas, inventions,
data, writings, protocols, discoveries, improvements, trade secrets, materials
or other proprietary information not generally known to the public, that arise
or are conceived or developed by or on behalf of either Party or its Affiliates,
or by or on behalf of the Parties or their Affiliates jointly, or are otherwise
Controlled by either Party or its Affiliates, in each case in connection with
any Existing Trials.
1.45 “FDA” shall mean the United States Food and Drug Administration and any
successor agency thereto.
1.46 “Finished Clinical Product” shall mean either (a) a Praluent Product,
containing as its only active ingredient Formulated Drug Substance, or (b)
placebo, in each case (a) and (b) in its finished (e.g., in an autoinjector),
labeled and packaged form, ready for use in clinical trials.
1.47 “Finished Product” shall mean a Praluent Product, containing as its only
active ingredient the Formulated Drug Substance, in its finished (i.e., in a DAI
autoinjector as such DAI autoinjector exists and is Commercialized as of the
Transition Date or, subject to the terms and conditions of Article 5 of the
Finished Product Supply Agreement, the [* * *] delivery device), labeled and
packaged form, ready for sale to the market, as the case may be.
1.48 “Finished Product Supply Agreement” shall have the meaning set forth in
Section 7.5(b).
1.49 [* * *].
1.50 “Force Majeure” shall have the meaning set forth in Article 15.
1.51 “Formulated Drug Substance” shall mean a Praluent Product containing as its
only active ingredient the Praluent Compound formulated into solution, ready for
storage or shipment to a Manufacturing facility, to allow processing into
finished, labeled and packaged form.
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1.52 “FTE” shall mean a full time equivalent employee or contract personnel
(i.e., one fully-committed or multiple partially-committed employees or contract
personnel aggregating to one full-time employee or contract personnel) employed
or contracted by a Party and assigned to perform specified work, with such
commitment of time and effort to constitute one employee or contract personnel
performing such work on a full-time basis, which for purposes hereof shall be [*
* *] hours per year. For purposes of the definition of FTE, “contract personnel”
refers to personnel (other than employees) who are engaged by a Party on an
individual basis and who are not accounted for as Out-of-Pocket Costs and does
not include Third Party entities to which activities under this Agreement have
been outsourced, such as contract manufacturers, contract research organizations
or other external service providers such as consulting firms.
1.53 “FTE Rate” shall mean US$[* * *] per FTE, with respect to employees, and
US$[* * *] per FTE, with respect to contract personnel, in the Calendar Year
ending December 31, 2020, such amounts to be adjusted as of January 1, 2021 and
annually thereafter by the sum of (a) the average of the percentage increases or
decreases, if any, in the [* * *] and the [* * *] for the twelve (12) months
ending June 30 of the Calendar Year prior to the Calendar Year for which the
adjustment is being made plus (b) [* * *] percent ([* * *]%) to reflect [* * *]
for each Calendar Year. Upon a variance of more than [* * *] percent ([* * *]%)
in the [* * *] since the Transition Date as calculated pursuant to Section 8.8,
the Parties shall meet to consider a revision to the FTE Rate.
1.54 “GAAP” shall mean generally accepted accounting principles in the United
States.
1.55 “Global Clinical Trials” shall have the meaning set forth in Section
4.2(a).
1.56 “Global Trial Cost Report” shall have the meaning set forth in Section
4.2(b).
1.57 “Global Trial Costs” shall have the meaning set forth on Schedule 1.57.
1.58 “Good Practices” shall mean compliance with the applicable standards
contained in then-current “Good Laboratory Practices,” “Good Manufacturing
Practices” or “Good Clinical Practices,” as promulgated by the FDA and all
analogous guidelines promulgated by the EMA, ICH or other country regulatory
agencies, as applicable.
1.59 “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.
1.60 “Grantee” shall have the meaning set forth in Section 2.3(c).
1.61 “Grantor” shall have the meaning set forth in Section 2.3(c).
1.62 “Human Biological Materials” shall have the meaning set forth in Section
4.6.
1.63 “IAS/IFRS” shall mean International Accounting Standards/International
Financial Reporting Standards of the International Accounting Standards Board.
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1.64 “ICH” shall mean the International Conference on Harmonization of Technical
Requirements for Requirements for Registration of Pharmaceuticals for Human Use.
1.65 “IND” shall mean an Investigational New Drug Application filed with the
FDA, as described in the FDA regulations, including all amendments and
supplements to the application.
1.66 “Indemnified Party” shall have the meaning set forth in Section 14.2(a).
1.67 “Indemnifying Party” shall have the meaning set forth in Section 14.2(a).
1.68 “Inventory Payment” shall have the meaning set forth in Section 8.5.
1.69 “Joint Information” shall mean (a) any Existing Joint Know-How and (b) any
Know-How included in the Joint Inventions under this Agreement.
1.70 “Joint Intellectual Property” shall mean Joint Patents and Joint
Information.
1.71 “Joint Inventions” shall have the meaning set forth in Section 10.1(b).
1.72 “Joint Patents” shall mean (a) Patents in the Joint Inventions or that
Cover a Joint Invention and (b) Joint Patent Rights (as defined in the LCA) that
exist as of the Transition Date and are related to the Praluent Compound or the
Praluent Products. The Joint Patents that exist as of the Transition Date are
set forth on Schedule 1.72.
1.73 “Joint Praluent Committee” or “JPC” shall have the meaning set forth in
Section 3.2.
1.74 “Know-How” shall mean any and all proprietary technical or scientific
information, know-how, data, materials, protocols, test results, knowledge,
techniques, discoveries, inventions, specifications, designs, trade secrets,
improvements and other information, including marketing or supply information
and data, and information and data included or referenced in the Regulatory
Filings made or Approvals, whether or not patentable or otherwise protected by
trade secret Law, in each case that are not claimed or disclosed in any
published Patents.
1.75 “Law” or “Laws” shall mean all laws, statutes, rules, regulations, orders,
judgments, injunctions or ordinances of any Governmental Authority in the
Territory.
1.76 “LCA” shall have the meaning set forth in the recitals hereto.
1.77 “LCA Amendment” shall have the meaning set forth in the recitals hereto.
1.78 “Lead Defense Party” shall have the meaning set forth in Section 11.4(b).
1.79 “Lead Enforcement Party” shall have the meaning set forth in Section
11.1(b).
1.80 “Litigation Costs” shall have the meaning set forth in Section
14.1(c)(i)(A).
1.81 “Manufacture” or “Manufacturing” shall mean all activities related to the
production, manufacture, making, processing, filling, finishing, packaging,
labeling, analytical testing, inspection,
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receiving, holding and shipping of any Praluent Product or biosimilar thereof,
as the case may be, or any constituents (including the Formulated Drug
Substance), placebo or a comparator agent, as the case may be or packaging
materials with respect thereto, or any intermediate of any of the foregoing,
including process and cost optimization, process qualification and validation,
release, testing, quality assurance and quality control. When used as a verb,
“Manufacture” shall mean to engage in Manufacturing, and when used as a noun,
“Manufacturer” shall mean a Person engaged in Manufacturing.
1.82 “Manufacturing Party” shall have the meaning set forth in Section 6.3(b).
1.83 “Manufacturing Transition Team” shall have the meaning set forth in Section
7.9(a).
1.84 “Marketing Approval” shall mean an Approval required for the marketing and
sale of a Praluent Product in a country in the Territory.
1.85 “Modified Clause” shall have the meaning set forth in Section 18.8.
1.86 “NDC” shall mean the “National Drug Code” registered by a company with the
FDA with respect to a pharmaceutical product.
1.87 “Net Sales” shall mean, with respect to a Praluent Royalty Product for any
Calendar Quarter, the gross amount billed or invoiced by Sanofi, its Affiliates
or its or their Sublicensees for the sale of such Praluent Royalty Product to
Third Parties, less the following deductions determined in accordance with
applicable Accounting Standards from such gross amounts which are actually
incurred, allowed, accrued or specifically allocated to the Praluent Royalty
Product:
(a) discounts, including cash, trade and quantity discounts inclusive of free
goods, price reduction programs (including co-pay assistance, compulsory refunds
or any other patient assistance programs), retroactive price adjustments with
respect to sales of a Praluent Royalty Product, charge-back payments and rebates
granted to managed health care organizations or to federal, state and local
governments (or their respective agencies, purchasers and reimbursors) or to
trade customers, including wholesalers and chain and pharmacy buying groups;
(b) amounts repaid or credited by reason of defects, damaged Praluent Royalty
Products, expired dating, rejections, recalls, refunds, returns, rebates and
billing errors;
(c) freight, postage, shipping and insurance charges actually allowed or paid
for delivery of a Praluent Royalty Product, which are separately identified on
the invoice or other documentation;
(d) [* * *]
(e) customs, taxes, duties or other governmental charges incurred in connection
with, levied on, absorbed or otherwise imposed on sale, exportation or
importation of Praluent Royalty Product, including value-added taxes, or
other governmental charges otherwise measured by the billing amount, when
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included in billing, as adjusted for rebates and refunds, but specifically
excluding taxes based on net income of the seller, which are separately
identified on the invoice or other documentation;
(f) [* * *]
(g) rebates, credits, compulsory refunds and similar payments made with respect
to sales paid for by any governmental or regulatory authority under any
governmental program similar or equivalent to Medicaid, Medicare outside the
United States;
(h) the portion of administrative fees paid during the relevant time period to
group purchasing organizations or pharmaceutical benefit managers relating to
the Praluent Royalty Product; and
(i) any other similar and customary deductions that are consistent with
Accounting Standards as determined from the books and records of Sanofi, its
Affiliates or its or their (sub)licensees, as the case may be, maintained in
accordance with Sanofi’s, its Affiliates’ or its or their (sub)licensees’ normal
practices. 
Any of the deductions listed 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. Any of the deductions listed above that involves a
payment by Sanofi, its Affiliates or its or their Sublicensees shall be taken as
a deduction in the Calendar Quarter in which the payment is accrued by such
entity.  For purposes of determining Net Sales, a Praluent Royalty Product shall
be deemed to be sold when it has met the applicable Accounting Standards’
revenue recognition criteria.  Net Sales shall not include transfers or
dispositions of such Praluent Royalty Product for pre-clinical or clinical
purposes, compassionate use or as samples, in each case, without
charge.  Sanofi’s, its Affiliates’ or its or their Sublicensees’ transfer of the
Praluent Royalty Product to an Affiliate or Sublicensee shall not result in any
Net Sales unless the transferee is an end user.
In the event that a Praluent Royalty Product is sold in any country in the form
of a combination product containing both the Praluent Compound or, where
applicable, biosimilar thereof and one or more other active ingredients (“Other
Ingredients”) (whether combined in a single formulation or package, as
applicable, or formulated or packaged separately but sold together for a single
price in a manner consistent with the terms of this Agreement) (a “Combination
Product”), Net Sales of such Combination Product shall be adjusted by
multiplying actual Net Sales of such Combination Product in such country
calculated pursuant to the foregoing definition of “Net Sales” by the fraction
A/(A+B), where A is the average net invoice price in such country of the
Praluent
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Royalty Product that contains the Praluent Compound or, where applicable,
biosimilar thereof as its sole active ingredient, if sold separately in such
country, and B is the average net invoice price in such country of, as
applicable, each product that contains such Other Ingredient(s) as its sole
active ingredient(s) if sold separately in such country; provided that the
invoice price in a country for Praluent Royalty Product that contains
the Praluent Compound or, where applicable, biosimilar thereof as its sole
active ingredient and such product that contains such Other Ingredient(s) as its
sole active ingredient(s) shall to the extent feasible be for quantities
comparable to those used in such Combination Product and of substantially the
same class, purity and potency or functionality, as applicable.  If either such
Praluent Royalty Product that contains the Praluent Compound or, where
applicable, biosimilar thereof as its sole active ingredient or any such product
that contains such Other Ingredient(s) as its sole active ingredient(s) is not
sold separately in a particular country, then the adjustment to Net Sales shall
be determined by the Parties in good faith to reasonably reflect the fair market
value of the contribution of such Praluent Royalty Product that contains the
Praluent Compound or, where applicable, biosimilar thereof as its sole active
ingredient to the total fair market value of such Combination Product.
In the case of pharmacy incentive programs, hospital performance incentive
programs, chargebacks, disease management programs, similar programs or
discounts on portfolio product offerings, all rebates, discounts and other forms
of reimbursements shall be allocated among products on the basis on which such
rebates, discounts and other forms of reimbursements were actually granted or,
if such basis cannot be determined, in accordance with Sanofi’s, its Affiliates’
or its or their Sublicensees’ existing allocation method; provided that any such
allocation shall be done in accordance with applicable Law, including any price
reporting laws, rules and regulations.
Subject to the above, Net Sales shall be calculated in accordance with the
standard internal policies and procedures of Sanofi, its Affiliates or its or
their Sublicensees, which shall be in accordance with applicable Accounting
Standards.
1.88 “New Regeneron License” shall mean any license entered into by Regeneron
(or any of its Affiliate(s)) with a Third Party after the Transition Date,
required for the U.S. Praluent Product Business.
1.89 “New Sanofi License” shall mean any license entered into by Sanofi (or any
of its Affiliate(s)) with a Third Party after the Transition Date, required for
the ROW Praluent Product Business.
1.90 “Non-Manufacturing Party” shall have the meaning set forth in Section
6.3(b).
1.91 “Other Existing Trial” shall mean any Existing Trial other than a Global
Clinical Trial.
1.92 “Other Ingredients” shall have the meaning set forth in the definition of
“Net Sales”.
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1.93 “Out-of-Pocket Costs” shall mean documented costs and expenses paid to
Third Parties (or payable to Third Parties and accrued in accordance with
applicable Accounting Standards) by either Party or its Affiliates, excluding
any such costs and expenses in respect of “contract personnel” that are
accounted for on an FTE basis in accordance with the definition of FTE. For the
avoidance of doubt, in no case shall any particular cost or expense be accounted
for hereunder both as an Out-of-Pocket Cost and as an FTE-based cost.
1.94 “Owed Party” shall have the meaning set forth in Section 8.7.
1.95 “Owing Party” shall have the meaning set forth in Section 8.7.
1.96 “Party” or “Parties” shall have the meaning set forth in the introductory
paragraph.
1.97 “Party Information” shall mean any and all trade secrets or other
proprietary information, including any proprietary data, inventions, ideas,
discoveries and materials (whether or not patentable or protectable as a trade
secret) not generally known to the public regarding a Party’s or its Affiliates’
technology, products, business or objectives, in each case that (a) were
disclosed under the LCA prior to the Transition Date to the extent specifically
related to the Praluent Products or (b) are disclosed or made available by or on
behalf of a Party or such Party’s Affiliates to the other Party or the other
Party’s Affiliates in connection with this Agreement or any Ancillary Services
Agreement. Notwithstanding the foregoing, (i) (A) the Regeneron Background
Know-How, (B) the Regeneron Core Know-How and (C) the Transferred Product
Records, in each case ((A) - (C)) shall be deemed to be the Party Information of
Regeneron and not of Sanofi, (ii) the Sanofi Background Know-How and the Sanofi
Core Know-How shall be deemed to be the Party Information of Sanofi and not of
Regeneron and (iii) “Party Information” shall in all cases be deemed to exclude
the Joint Information.
1.98 “[* * *]” shall have the meaning set forth in Section 10.2(c).
1.99 “Patent Infringement” shall have the meaning set forth in Section 11.1(a).
1.100 “Patents” shall mean (a) all national, regional and international patents
and patent applications, including provisional patent applications; (b) all
patent applications filed either from such patents, patent applications or
provisional applications or from an application claiming priority from either of
these, including divisionals, continuations, continuations-in-part,
provisionals, converted provisionals and continued prosecution applications;
(c) any and all patents that have issued or in the future issue from the
foregoing patent applications ((a) and (b)), including utility models, petty
patents, innovation patents and design patents and certificates of invention;
(d) any and all extensions or restorations by existing or future extension or
restoration mechanisms, including revalidations, reissues, re-examinations and
extensions (including any supplementary protection certificates and the like) of
the foregoing patents or patent applications ((a), (b) and (c)); and (e) any
similar rights, including so-called pipeline protection or any importation,
revalidation, confirmation or introduction patent or registration patent or
patent of additions to any of such foregoing patent applications and patents.
1.101 “Person” shall mean and include an individual, a partnership, a joint
venture, a limited liability company, a corporation, a firm, a trust, an
unincorporated organization and a government or other department or agency
thereof.
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1.102 “PMDA” shall mean the Pharmaceutical and Medical Devices Agency and any
successor agency thereto.
1.103 “Praluent Bill of Sale” shall mean that certain Praluent Bill of Sale and
Assignment and Assumption Agreement, by and between the Parties, entered into as
of the Execution Date and effective as of the Transition Date.
1.104 “Praluent Compound” shall mean the biological compound alirocumab.
1.105 “Praluent Domain Name Assignment” shall mean that certain Praluent Domain
Name Assignment Agreement, by and among Regeneron, Sanofi and Sanofi Parent,
entered into as of the Execution Date and effective as of the Transition Date.
1.106 “Praluent Master Cell Bank” shall mean the master cell bank used by
Regeneron or any of its Affiliates to Manufacture Formulated Drug Substance as
of the Transition Date.
1.107 “Praluent Pharmacovigilance Transition Services Agreement” shall mean that
certain Praluent Pharmacovigilance Transition Services Agreement, by and between
the Parties, entered into as of the Execution Date and effective as of the
Transition Date.
1.108 “Praluent Product” shall mean any product that is comprised of or contains
the Praluent Compound as an active ingredient, whether alone or in fixed dose
combination with one or more additional active ingredients.
1.109 “Praluent Product Domain Names” shall mean the Praluent Product ROW Domain
Names or the Praluent Product U.S. Domain Names, as applicable.
1.110 “Praluent Product Regeneron Copyrights” shall mean all Copyright(s) owned
or Controlled by Regeneron or its Affiliates or its or their Sublicensees as of
the Transition Date that are used in connection with, or are otherwise necessary
or useful for, the ROW Praluent Product Business.
1.111 “Praluent Product ROW Domain Names” shall mean any Domain Name(s) owned or
Controlled by Sanofi or its Affiliates or its or their Sublicensees and used or
to be used by Sanofi or its Affiliates or its or their Sublicensees for the
Commercialization of Praluent Products in the Sanofi Territory.
1.112 “Praluent Product ROW Trademarks” shall mean any Trademark(s) owned or
Controlled by Sanofi or its Affiliates or its or their Sublicensees and used or
to be used by Sanofi or its Affiliates or its or their Sublicensees for the
Commercialization of Praluent Products in the Sanofi Territory and any
registrations thereof or any pending applications relating thereto in the Sanofi
Territory (excluding, in any event, the corporate name or logo of either Party
or its Affiliates or its or their (sub)licensees).
1.113 “Praluent Product Sanofi Copyrights” shall mean all Copyright(s) owned or
Controlled by Sanofi or its Affiliates or its or their Sublicensees as of the
Transition Date that are used in connection with, or are otherwise necessary or
useful for, the conduct of the U.S. Praluent Product Business.
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1.114 “Praluent Product Trademarks” shall mean the Praluent Product ROW
Trademarks or the Praluent Product U.S. Trademarks, as applicable.
1.115 “Praluent Product U.S. Domain Names” shall mean any Domain Name(s) owned
or Controlled by Regeneron or its Affiliates or its or their Sublicensees and
used or to be used by Regeneron or its Affiliates or its or their Sublicensees
for the Commercialization of Praluent Products in the Regeneron Territory,
including the Transferred Product Domain Names.
1.116 “Praluent Product U.S. Trademarks” shall mean any Trademark(s) owned or
Controlled by Regeneron or its Affiliates or its or their Sublicensees and used
or to be used by Regeneron or its Affiliates or its or their Sublicensees for
the Commercialization of Praluent Products in the Regeneron Territory and any
registrations thereof or any pending applications relating thereto in the United
States (excluding, in any event, the corporate name or logo of either Party or
its Affiliates or its or their (sub)licensees), including the Transferred
Product Trademarks.
1.117 “Praluent Royalty Product” shall mean any Praluent Product [* * *]
developed by or on behalf of Sanofi or any of its Affiliates or its or their
Sublicensees, but, with respect to any country in the Sanofi Territory other
than [* * *], excluding [* * *].
1.118 “Praluent Services Agreement” shall have the meaning set forth in Section
2.8.
1.119 “Praluent Substance Supply Agreement” shall have the meaning set forth in
Section 7.5(a).
1.120 “Praluent Supply Agreements” shall mean the Praluent Substance Supply
Agreement and the Finished Product Supply Agreement and any related quality
agreements.
1.121 “Praluent Trademark Assignment” shall mean that certain Praluent Trademark
Assignment Agreement, by and between the Parties, entered into as of the
Execution Date and effective as of the Transition Date.
1.122 “Praluent Transition Services Agreement” shall mean that certain Praluent
Transition Services Agreement, by and between Regeneron Healthcare Solutions,
Inc. and Sanofi-Aventis U.S. LLC., entered into as of the Execution Date and
effective as of the Transition Date.
1.123 “Praluent Working Cell Bank” shall mean working cell bank generated from
the Praluent Master Cell Bank.
1.124 “Pricing Approval” shall mean any Approval, or any agreement,
determination or governmental decision, establishing prices for a Praluent
Product that can be charged to consumers and will be reimbursed by Governmental
Authorities in countries in the Territory where Governmental Authorities or
Regulatory Authorities of such country approve or determine pricing for
pharmaceutical products for reimbursement or otherwise.
1.125 “Promotional Materials” shall mean promotional, advertising, communication
and educational materials relating to any Praluent Product for use in connection
with the marketing,
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promotion and sale of, or educational activities with respect to, the Praluent
Product, and the content thereof, and shall include promotional literature,
product support materials and promotional giveaways.
1.126 “Publishing Party” shall have the meaning set forth in Section 13.5.
1.127 “Recall Cost” shall mean, with respect to a recall, market suspension or
market withdrawal, the product of (a) the number of FTEs used to carry out such
recall, market suspension or market withdrawal and (b) the applicable FTE
Rate(s), plus any Out-of-Pocket Costs incurred by the applicable Party or its
Affiliates in respect of such recall, market suspension or market withdrawal.
1.128 “Regeneron” shall have the meaning set forth in the introductory
paragraph.
1.129 “Regeneron Background Intellectual Property” shall mean the Regeneron
Background Patents and the Regeneron Background Know-How.
1.130 “Regeneron Background Know-How” shall mean any and all Know-How Controlled
by Regeneron or any of its Affiliates as of or after the Transition Date that is
necessary or useful for the Development, Manufacturing or Commercialization of
any Existing Praluent Product for any Existing Indication, excluding the
Regeneron Core Know-How and the Joint Information.
1.131 “Regeneron Background Patents” shall mean any and all Patents Controlled
by Regeneron or any of its Affiliates as of or after the Transition Date to the
extent Covering the use, making, sale, offer for sale or import of any Existing
Praluent Product for any Existing Indication, excluding the Regeneron Core
Patents and the Joint Patents.
1.132 “Regeneron Cell Media” shall mean any cell culture media that is
proprietary to Regeneron and used by Regeneron or any of its Affiliates to
Manufacture Formulated Drug Substance as of the Transition Date.
1.133 “Regeneron Core Intellectual Property” shall mean the Regeneron Core
Patents and the Regeneron Core Know-How.
1.134 “Regeneron Core Know-How” shall mean any and all Know-How Controlled by
Regeneron or any of its Affiliates as of the Transition Date that was conceived
or developed by Regeneron or any of its Affiliates under the LCA or the
Discovery Agreement and that is related to any Praluent Product, including, for
clarity, any Know-How Controlled by Regeneron or any of its Affiliates as of the
Transition Date that is contained or referenced in the Transferred Approvals,
Transferred Regulatory Documentation or other Transferred U.S. Assets, but
excluding any Regeneron Manufacturing Know-How or Joint Information.
1.135 “Regeneron Core Patents” shall mean those Patents Controlled by Regeneron
or any of its Affiliates as of or after the Transition Date that contain
composition of matter, method of use or formulation claims for any Existing
Praluent Product for any Existing Indication, including the Patents listed on
Schedule 1.135.
1.136 “Regeneron Indemnitees” shall have the meaning set forth in Section
14.1(a).
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1.137 “Regeneron Managed Patents” shall have the meaning set forth in Section
10.2(a).
1.138 “Regeneron Manufacturing Know-How” shall mean any and all Know-How
Controlled by Regeneron or any of its Affiliates as of or after the Transition
Date that is related to the Manufacture of the Praluent Compound or any Praluent
Product, including all CMC data for the Praluent Compound that is included or
referenced in, or that otherwise supports, an Approval.
1.139 “Regeneron Manufacturing Site Notice” shall have the meaning set forth in
Section 7.2(a).
1.140 “Regeneron Sole Inventions” shall have the meaning set forth in Section
10.1(a).
1.141 “Regeneron Territory” shall mean the United States.
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 Development, Manufacture and
Commercialization of any Praluent Product in a country in the Territory,
including the FDA in the United States, the EMA in Europe and the PMDA in Japan.
1.143 “Regulatory Filing” shall mean the application to the relevant Regulatory
Authority for any Approval, and shall include any testing, marketing
authorization application, marketing authorization renewal application, Annual
Product Quality review application, device application, supplementary
application or variation thereof.
1.144 “ROW CPI” shall mean the Harmonized Index of Consumer Prices, overall for
working days as seasonally adjusted, referenced as ICP.M.U2.Y.000000.3.INX (or
its successor equivalent index), which is published monthly and available via
the European Central Bank internet site.
1.145 “ROW Praluent Product Business” shall mean the Development or Manufacture
of the Praluent Products (including the Praluent Compound) anywhere in the
Territory for the Sanofi Territory, or the Commercialization of the Praluent
Products in the Sanofi Territory.
1.146 “Royalty Report” shall have the meaning set forth in Section 8.3.
1.147 “Royalty Term” shall have the meaning set forth in Section 8.1(b).
1.148 “Safety Data Exchange Agreement” shall have the meaning set forth in
Section 6.4.
1.149 “Sales Deduction Costs” shall mean, with respect to any period, items
deducted from gross sales, solely attributable to Praluent Products, but
excluding the cost of recalls (such costs are allocated between the Parties in
accordance with Section 6.6). As an example, Sales Deduction Costs include the
types of deductions taken in the determination of Net Sales (excluding recalls),
including the costs of returns, cash discounts, contracted discounts, rebates,
chargebacks or wholesaler fees incurred by a Party or any of its Affiliates
(whether paid out-of-pocket or taken as deductions from invoices collected by
such Party during such period).
1.150 “Sanofi” shall have the meaning set forth in the introductory paragraph.
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1.151 “Sanofi Background Intellectual Property” shall mean the Sanofi Background
Patents and the Sanofi Background Know-How.
1.152 “Sanofi Background Know-How” shall mean any and all Know-How Controlled by
Sanofi or any of its Affiliates as of or after the Transition Date that is
necessary or useful for the Development, Manufacturing or Commercialization of
any Existing Praluent Product for any Existing Indication, excluding the Sanofi
Core Know-How and the Joint Information.
1.153 “Sanofi Background Patents” shall mean any and all Patents Controlled by
Sanofi or any of its Affiliates as of or after the Transition Date to the extent
Covering the use, making, sale, offer for sale or import of any Existing
Praluent Product for any Existing Indication, excluding the Sanofi Core Patents
and the Joint Patents.
1.154 “Sanofi Core Intellectual Property” shall mean the Sanofi Core Patents and
Sanofi Core Know-How.
1.155 “Sanofi Core Know-How” shall mean any and all Know-How Controlled by
Sanofi or any of its Affiliates as of the Transition Date that was conceived or
developed by Sanofi or any of its Affiliates under the LCA or the Discovery
Agreement and that is related to any Praluent Product, including, for clarity,
any Know-How Controlled by Sanofi or any of its Affiliates as of the Transition
Date that is contained or referenced in the Transferred Approvals, Transferred
Regulatory Documentation or other Transferred U.S. Assets, but excluding any
Sanofi Manufacturing Know-How or Joint Information.
1.156 “Sanofi Core Patents” shall mean those Patents Controlled by Sanofi or any
of its Affiliates as of or after the Transition Date that contain composition of
matter, method of use or formulation claims for any Existing Praluent Product
for any Existing Indication, including the Patents listed on Schedule 1.156.
1.157 “Sanofi Indemnitees” shall have the meaning set forth in Section 14.1(b).
1.158 “Sanofi Managed Patents” shall have the meaning set forth in Section
10.2(b).
1.159 “Sanofi Manufacturing Know-How” shall mean any and all Know-How Controlled
by Sanofi or any of its Affiliates as of or after the Transition Date that is
related to Manufacture of the Praluent Compound or any Praluent Product.
1.160 “Sanofi Parent” shall mean Sanofi, a société anonyme organized under the
laws of France and having a registered office at 54 rue La Boétie, 75008 Paris,
France.
1.161 “Sanofi ROR Authorization” shall mean any letter of authorization from a
Third Party that permits Sanofi or any of its Affiliates to reference any
regulatory documentation, data or information of such Third Party with respect
to any Existing Praluent Product in any Existing Indication.
1.162 “Sanofi Samples” shall have the meaning set forth in Section 4.7.
1.163 “Sanofi Sole Inventions” shall have the meaning set forth in Section
10.1(a).
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1.164 “Sanofi Territory” shall mean all of the countries and territories of the
world other than the Regeneron Territory.
1.165 “Selected Recall” shall have the meaning set forth in Section 6.6(a).
1.166 “Sole Inventions” shall have the meaning set forth in Section 10.1(a).
1.167 “Special Claim” shall have the meaning set forth in Section 14.1(c).
1.168 “Sublicensee” shall mean a Third Party to whom a Party or its Affiliate
will have granted (a) a license or sublicense to Manufacture, Develop or
Commercialize Praluent Royalty Products in the Territory or (b) the right to
distribute Praluent Royalty Products whereby such Third Party provides
consideration to such Party or its Affiliate for such distribution rights or in
connection with the sale of Praluent Royalty Products other than the supply
price for Praluent Royalty Products sold to such Third Party by such Party or
its Affiliate, irrespective of whether a license or sublicense or further right
of reference is granted under Section 2.3. For clarity, “Sublicensee” shall not
include any bona fide commercial distributor that pays to such Party or its
Affiliate only a supply price for the Praluent Royalty Products ordered from
such Party or its Affiliate.
1.169 “Tech Transfer FTE Cost” shall mean, for all activities performed by a
Party in accordance with a Tech Transfer Plan, the product of (a) the number of
FTEs used to carry out such activities and (b) the applicable FTE Rate(s).
1.170 “Tech Transfer Plan” shall have the meaning set forth in Section 7.4(a).
1.171 “Technology Transfer Cost Report” shall have the meaning set forth in
Section 7.4(c).
1.172 “Terminating Party” shall have the meaning set forth in Section 16.2.
1.173 “Territory” shall mean either Sanofi Territory or Regeneron Territory or,
as applicable, both of Sanofi Territory and Regeneron Territory.
1.174 “Third Party” shall mean any Person other than Sanofi or Regeneron or any
Affiliate of either Party.
1.175 “Third Party Claim” shall have the meaning set forth in Section 14.1(a).
1.176 “Third Party Invalidity Assertion” shall have the meaning set forth in
Section 11.4(a).
1.177 “Trademark” shall mean any trademark, service mark, trade name, trade
dress, logo, slogan, design or other designation that functions as an identifier
of source, whether or not registered, and all statutory and common law rights
therein, and all registrations and applications therefor and renewals thereof,
together with all goodwill associated with, or symbolized by, any of the
foregoing.
1.178 “Transferee” shall have the meaning set forth in Section 7.4(a).
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1.179 “Transferor” shall have the meaning set forth in Section 7.4(a).
1.180 “Transferred Approvals” shall mean the Approvals set forth on Schedule
1.180. For clarity, the term “Transferred Approvals” shall only refer to the
approvals, registrations, licenses or authorizations granted by the applicable
Regulatory Authority and expressly excludes any Sanofi Core Know-How or any of
Sanofi’s rights in or to the Existing Joint Know-How included or referenced
therein, which shall be subject to the license grants in Section 2.2. The
transfer to Regeneron of the Transferred Approvals under Section 2.6 shall not
operate to vest or result in any assignment or transfer of any rights, title or
interest in and to such Know-How.
1.181 “Transferred Inventory” means all inventories of Finished Product intended
for sale or distribution in the Regeneron Territory, including samples intended
for distribution in the Regeneron Territory, that are held by Sanofi or any of
its Affiliates and unsold (or, with respect to samples, undistributed) as of the
Transition Date.
1.182 “Transferred Product Contracts” shall mean all rights and interests of
Sanofi or its Affiliates under the contracts set forth on Schedule 1.182.
1.183 “Transferred Product Domain Names” shall mean the Domain Names set forth
on Schedule 1.183 and all subdomains thereof.
1.184 “Transferred Product Records” shall mean all books and records (other than
the Transferred Regulatory Documentation and any contracts or agreements) solely
related to the Commercialization of Praluent Products in the Regeneron
Territory, including all books and records that correspond to the items listed
on Schedule 1.184 and that are solely related to the Commercialization of
Praluent Products in the Regeneron Territory, owned by Sanofi or its Affiliates
as of the Transition Date or during the Distribution Service Period (as defined
in the Praluent Transition Services Agreement), including all information
provided to Regeneron pursuant to the Schedules (as defined in the Praluent
Transition Services Agreement).
1.185 “Transferred Product Trademarks” shall mean the Trademarks set forth on
Schedule 1.185.
1.186 “Transferred Product Trademarks Documentation” shall mean all trademark
registration certificates and maintenance documents (Declaration of Use) and, as
the case may be, prosecution files and trademark clearance search results, in
each case, that may be in the possession or Control of Sanofi or its Affiliates
or its or their outside Trademark counsel as of the Transition Date relating to
the Transferred Product Trademarks.
1.187 “Transferred Promotional Materials” shall mean all Promotional Materials
to the extent used or intended for use by either Party or its Affiliates for the
Commercialization of the Existing Praluent Products in the Regeneron Territory
and in the possession of Sanofi or its Affiliates as of the Transition Date.
1.188 “Transferred Regulatory Documentation” shall mean (a) all documentation
comprising the Transferred Approvals, and all reports, regulatory applications,
submissions and filings
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in connection therewith and (b) all correspondence and reports submitted to or
received from Governmental Authorities in the Regeneron Territory to the extent
related to any such Approvals or to the Commercialization of any Existing
Praluent Product for any Existing Indication in the Regeneron Territory, and all
relevant supporting documents with respect thereto, in each case ((a) and (b)),
in the possession or Control of Sanofi or any of its Affiliates as of the
Transition Date. For clarity, the term “Transferred Regulatory Documentation”
shall only refer to the embodiments of such documentation, reports,
applications, submissions, filings or correspondence and expressly excludes any
Sanofi Core Know-How or any of Sanofi’s rights in or to the Existing Joint
Know-How included or referenced therein, which shall be subject to the license
grants in Section 2.2. The transfer to Regeneron of the Transferred Regulatory
Documentation under Section 2.6 shall not operate to vest or result in any
assignment or transfer of any rights, title or interest in and to such Know-How.
For the avoidance of doubt, the term “Transferred Regulatory Documentation”
shall not include any Trademark or Domain Name registration documentation,
prosecution or enforcement files or Trademark clearance searches or conflict or
opposition records and files.
1.189 “Transferred U.S. Assets” shall mean the following rights and assets: (a)
the Transferred Approvals, (b) Transferred Inventory, (c) the Transferred
Product Contracts, (d) the Transferred Product Domain Names, (e) the Transferred
Product Records, (f) the Transferred Product Trademarks, (g) the Transferred
Promotional Materials, (h) the Transferred Regulatory Documentation, and (i)
Transferred Product Trademarks Documentation.
1.190 “Transition Date” shall have the meaning set forth in the recitals hereto.
1.191 “Triggering Event” shall mean, (a) with respect to any Third Party Claim
alleging [* * *] or (b) with respect to any [* * *] Third Party Claim alleging
[* * *].
1.192 “United States” or “U.S.” shall mean the United States of America
(including its territories and possessions and its military bases and
commissaries, and any other federal government purchasers, wherever located in
the Territory) and Puerto Rico.
1.193 “U.S. CPI” shall mean the Consumer Price Index – All Urban Consumers
published by the United States Department of Labor, Bureau of Statistics (or its
successor equivalent index).
1.194 “U.S. Praluent Product Business” shall mean the Development or Manufacture
of the Praluent Products (including the Praluent Compound) anywhere in the
Territory for the Regeneron Territory, or the Commercialization of the Praluent
Products in the Regeneron Territory.
1.195 “U.S.-Related Praluent Agreements” shall mean the agreements, including
all amendments thereto existing as of the Transition Date to which Sanofi or its
Affiliates are a party that relate to the Commercialization of any Existing
Praluent Product for any Existing Indication in the Regeneron Territory,
excluding the Transferred Product Contracts.
ARTICLE 2
LICENSE GRANTS; LIMITED ASSET TRANSFER; TRANSITION COSTS
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2.1 Regeneron License Grants. Subject to the terms and conditions of this
Agreement, Regeneron (on behalf of itself and its Affiliates) hereby grants to
Sanofi and its Affiliates:
(a)an exclusive (including with regard to Regeneron and its Affiliates),
royalty-bearing, sublicensable (pursuant to Section 2.3), transferable (pursuant
to Section 18.10) right and license under the Regeneron Core Intellectual
Property, the Regeneron Background Intellectual Property and Regeneron’s
interest in the Joint Intellectual Property to Commercialize the Praluent
Royalty Products in the Sanofi Territory;
(b)a co-exclusive, royalty-bearing, sublicensable (pursuant to Section 2.3),
transferable (pursuant to Section 18.10) right and license under the Regeneron
Core Intellectual Property, the Regeneron Background Intellectual Property, and
Regeneron’s interest in the Joint Intellectual Property to use (other than to
Commercialize), Develop and Manufacture the Praluent Royalty Products (including
the Praluent Compound) anywhere in the Territory, solely to support
Commercialization of the Praluent Royalty Products in the Sanofi Territory;
(c)a co-exclusive, royalty-free, sublicensable (pursuant to Section 2.3),
transferable (pursuant to Section 18.10) right and license to reproduce, modify,
distribute, create derivative works based on, including translations of,
publicly perform, publicly display, publish and otherwise use the Praluent
Product Regeneron Copyrights, in all forms and media, now known or hereafter
invented, solely to support the ROW Praluent Product Business;
(d)subject to Section 9.3(b), a co-exclusive, royalty-free, fully paid-up,
sublicensable (pursuant to Section 2.3), transferable (pursuant to Section
18.10) license to use the Praluent Product U.S. Trademarks to Develop and
Manufacture the Praluent Products in the Regeneron Territory solely to support
the ROW Praluent Product Business; and
(e)subject to Section 9.4(b), the right, free of charge, to use the name or logo
of Regeneron or its Affiliate (i) on product labels, package inserts, packaging,
trade packaging, samples and all Promotional Materials that are being used for
the Commercialization of the Praluent Products in the Sanofi Territory as of the
Transition Date, only for the time period (which in any case may not exceed [* *
*] years after the Transition Date or such other maximum period as may be agreed
by the Parties) and solely to the extent necessary to exhaust the inventory of
such product labels, package inserts, packaging, trade packaging, samples and
Promotional Materials, in each case existing as of the Transition Date and
containing such name or logo or (ii) as necessary to identify, to the extent
required under any applicable Law, Regeneron (or its Affiliate) as the
Manufacturer of Formulated Drug Substance on any product labels, package
inserts, packaging, trade packaging or samples of Praluent Products to be used
by Sanofi or its Affiliates or its or their Sublicensees in the ROW Praluent
Product Business that incorporate Formulated Drug Substance Manufactured by
Regeneron (or its Affiliate).
2.2 Sanofi License Grants. Subject to the terms and conditions of this
Agreement, Sanofi (on behalf of itself and its Affiliates) hereby grants to
Regeneron and its Affiliates:
(a)an exclusive (including with regard to Sanofi and its Affiliates), fully
paid-up, royalty-free, sublicensable (pursuant to Section 2.3), transferable
(pursuant to Section 18.10)
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right and license under the Sanofi Core Intellectual Property, the Sanofi
Background Intellectual Property and Sanofi’s interest in the Joint Intellectual
Property to Commercialize the Praluent Products or any biosimilar thereof in the
Regeneron Territory;
(b)a co-exclusive, fully paid-up, royalty-free, sublicensable (pursuant to
Section 2.3), transferable (pursuant to Section 18.10) right and license under
the Sanofi Core Intellectual Property, the Sanofi Background Intellectual
Property and Sanofi’s interest in the Joint Intellectual Property to use (other
than to Commercialize), Develop and Manufacture the Praluent Products (including
the Praluent Compound) or any biosimilar thereof anywhere in the Territory,
solely to support Commercialization of the Praluent Products or any biosimilar
thereof in the Regeneron Territory;
(c)a co-exclusive, royalty-free, sublicensable (pursuant to Section 2.3),
transferable (pursuant to Section 18.10) right and license to reproduce, modify,
distribute, create derivative works based on, including translations of,
publicly perform, publicly display, publish and otherwise use the Praluent
Product Sanofi Copyrights, in all forms and media, now known or hereafter
invented, solely to support the U.S. Praluent Product Business;
(d)subject to Section 9.3(b), a co-exclusive, royalty-free, fully paid-up,
sublicensable (pursuant to Section 2.3), transferable (pursuant to Section
18.10), license to use the Praluent Product ROW Trademarks to Develop and
Manufacture the Praluent Products in the Sanofi Territory solely to support the
U.S. Praluent Product Business; and
(e)subject to Section 9.4(b), the right, free of charge, to use the name or logo
of Sanofi or its Affiliate (i) on product labels, package inserts, packaging,
trade packaging, samples and all Transferred Promotional Materials, only for the
time period (which in any case may not exceed [* * *] years after the Transition
Date or such other maximum period as may be agreed by the Parties) and solely to
the extent necessary to exhaust the inventory of such product labels, package
inserts, packaging, trade packaging, samples and Promotional Materials existing
as of the expiration of the Distribution Service Period (as defined in the
Praluent Transition Services Agreement) and containing such name or logo or (ii)
as necessary to identify, to the extent required under any applicable Law,
Sanofi (or its Affiliate) as the Manufacturer of Finished Product on any product
labels, package inserts, packaging, trade packaging or samples of Praluent
Products to be used by Regeneron or its Affiliates or its or their Sublicensees
in the U.S. Praluent Product Business that incorporate Finished Product
Manufactured by Sanofi (or its Affiliate).
2.3 Sublicensing and Subcontracting.
(a)Subject to Section 2.3(c), (i) the licenses granted by Regeneron to Sanofi in
Section 2.1 and the rights of reference granted by Regeneron to Sanofi in
Section 6.2(a) may be freely sublicensed, or further rights of reference may be
granted, by Sanofi or its Affiliates to Third Parties through one or multiple
tiers and (ii) the licenses granted by Sanofi to Regeneron in Section 2.2 and
the rights of reference granted by Sanofi to Regeneron in Section 6.2(b) and
Section 6.2(c) may be freely sublicensed, or further rights of reference may be
granted, by Regeneron or its Affiliates to Third Parties through one or multiple
tiers.
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(b)Subject to Section 2.3(c), either Party may, as such Party deems appropriate,
delegate any of its obligations hereunder or subcontract the performance of all
or part of such Party’s activities with respect to the U.S. Praluent Product
Business, in the case of Regeneron, or the ROW Praluent Product Business, in the
case of Sanofi, in each case to its Affiliates or Third Parties.
(c)Sublicensing or subcontracting by either Party or its Affiliates (the
“Grantee”) of any Manufacturing rights granted by the other Party (the
“Grantor”) hereunder (or any agreement under which any Third Party will
Manufacture Praluent Compound or Praluent Products on behalf of the Grantee) (i)
shall require the Grantor’s consent, not to be unreasonably withheld,
conditioned or delayed and (ii) without limiting clause (i), shall [* * *]. Each
Party acknowledges and agrees that it would be reasonable for the other Party to
[* * *]. For the avoidance of doubt, [* * *].
(d)A sublicensing, subcontracting or delegating Party shall ensure that its
sublicensees (including Sublicensees), subcontractors and delegatees are bound
by terms and conditions that are consistent with the applicable terms and
conditions of this Agreement, including the confidentiality and non-use
obligations set forth in Article 13, and such terms and conditions must include,
with respect to a Sublicensee of Sanofi or its Affiliate, an obligation of the
Sublicensee to account for and report its sales of Praluent Products to Sanofi
or such Affiliate on the same basis as if such sales were Net Sales by Sanofi or
its Affiliate. For the avoidance of doubt, Regeneron shall be entitled to
receive royalties under this Agreement based on Net Sales of Praluent Products
sold by Sanofi’s or its Affiliates’ Sublicensees. Each Party shall notify the
other Party within thirty (30) days of the grant of any sublicense or the
appointment of any Sublicensee by such Party or its Affiliates or its or their
Sublicensees pursuant to this Section 2.3. Each Party shall remain liable for
any action or failure to act by its Affiliates, sublicensees (including
Sublicensees), subcontractors or delegatees to whom such Party’s rights and
obligations under this Agreement have been delegated, subcontracted or
sublicensed and which action or failure to act would constitute a breach of this
Agreement if such action or failure to act were committed by such Party.
(e)For clarity, each Party may freely (sub)license any of its retained rights
under Section 2.5 through one or multiple tiers.
2.4 Limitations.
(a)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 in
or to the other Party’s Patents, Know-How, Party Information or the other
Party’s interest in the Joint Intellectual Property either expressly or by
implication, estoppel or otherwise.
(b)No Sequencing or Reverse Engineering. Sanofi shall not, and shall ensure that
its Affiliates and its and their Sublicensees do not, reverse engineer any cell
lines, media or feeds or any other proprietary materials in the Regeneron
Manufacturing Know-How, including Regeneron Cell Media, Praluent Working Cell
Bank or Praluent Master Cell Bank.
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2.5 Retained Rights.
(a)For the avoidance of doubt, Regeneron expressly reserves for itself and its
Affiliates and its and their Third Party (sub)licensees under the Regeneron Core
Intellectual Property, the Regeneron Background Intellectual Property and
Regeneron’s interest in the Joint Intellectual Property the right to (i) fulfill
its Manufacturing obligations under the Praluent Supply Agreements and (ii)
Develop and Commercialize any product that is owned or controlled by Regeneron
or any of its Affiliates for use with Praluent Products in the Sanofi Territory.
For the further avoidance of doubt, Regeneron retains all rights in Regeneron
Core Intellectual Property, Regeneron Background Intellectual Property and
Regeneron’s interest in the Joint Intellectual Property not expressly licensed
hereunder.
(b)For the avoidance of doubt, Sanofi expressly reserves for itself and its
Affiliates and its and their Third Party (sub)licensees under the Sanofi Core
Intellectual Property, the Sanofi Background Intellectual Property and Sanofi’s
interest in the Joint Intellectual Property the right to (i) fulfill its
Manufacturing obligations under the Praluent Supply Agreements and (ii) Develop
and Commercialize any product that is owned or controlled by Sanofi or any of
its Affiliates for use with Praluent Products in the Regeneron Territory. For
the further avoidance of doubt, Sanofi retains all rights in Sanofi Core
Intellectual Property, Sanofi Background Intellectual Property and Sanofi’s
interest in the Joint Intellectual Property not expressly licensed hereunder.
2.6 Limited Asset Transfer.
(a)Sanofi shall, and shall cause its Affiliates to, and does hereby, assign to
Regeneron all of its right, title and interest in and to, and transfer to
Regeneron (or its designee), the Transferred U.S. Assets free and clear of any
encumbrance, lien or claim of ownership of any Third Party. Without limiting the
foregoing, the Parties shall commence the transfer of all Transferred U.S.
Assets to Regeneron immediately after the Transition Date or such other time as
may be specified in the schedules to the Praluent Transition Services Agreement
or as the Parties may otherwise agree in writing with respect to certain
Transferred U.S. Assets. For clarity, other than in respect of the Transferred
Product Trademarks, this Agreement shall not vest in Regeneron ownership of, or
result in any assignment or transfer by Sanofi or its Affiliates to Regeneron
of, any rights, title or interest in and to any Patents, Know-How or other
intellectual property rights owned or controlled by Sanofi or its Affiliates as
of the Transition Date in respect of any Praluent Product, including the Sanofi
Background Intellectual Property, Sanofi Core Intellectual Property and any
interest of Sanofi in the Joint Intellectual Property, other than pursuant to
the Sanofi license grants under Section 2.2 or the rights of reference granted
by Sanofi under Section 6.2.
(b)Further Assurances. From time to time after the transfer of the Transferred
U.S. Assets to Regeneron in accordance with Section 2.6(a), and for no further
consideration except as otherwise provided in the Praluent Transition Services
Agreement, Sanofi shall, and shall (i) cause its Affiliates and (ii) use
commercially reasonable efforts to cause applicable Third Parties to, execute,
acknowledge and deliver such assignments, transfers, consents, assumptions and
other documents and instruments and take such other actions as may
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reasonably be requested by Regeneron to more effectively assign, convey or
transfer to or vest in Regeneron and its designee(s), all right, title and
interest in and to the Transferred U.S. Assets.
(c)Maintenance of Transferred U.S. Assets Prior to Transfer.
(i) Except as may be required or prohibited by applicable Law or as may be
required under any Ancillary Agreement, prior to the transfer of the applicable
Transferred U.S. Asset to Regeneron, Sanofi shall, and shall cause its
Affiliates and shall use commercially reasonable efforts to cause applicable
Third Parties to:
(A)maintain each Transferred U.S. Asset until such time as such Transferred U.S.
Asset is transferred to Regeneron pursuant to this Section 2.6, in each case, in
substantially the same manner as maintained by or on behalf of Sanofi
immediately prior to the Transition Date;
(B)not take or omit to take any action that would reasonably be expected to have
a materially adverse effect on any Transferred Approvals or any Regulatory
Filings in the Transferred Regulatory Documentation;
(C)not commence, compromise or settle any action, claim, action, suit, audit,
assessment, arbitration or proceeding related to the Transferred U.S. Assets;
and
(D)not enter into any agreements, make any commitments or make any offer (in
writing or otherwise) to take any of the actions described in this Section
2.6(c), except as may be agreed to in writing by the Parties.
(ii) Notwithstanding anything to the contrary in Section 2.6(c)(i), Sanofi may,
and may cause its Affiliates and applicable Third Parties to, take reasonable
actions in compliance with applicable Laws or, to the extent consistent with
Sanofi’s actions in respect of its business generally, as necessary to respond
to operational emergencies (including any measures in response to any Force
Majeure event) or immediate and material threats to the health or safety of
natural Persons or the overall economic stability of the businesses of Sanofi,
its Affiliates or such applicable Third Parties, as the case may be, provided
that such actions taken in respect of such emergencies, events or threats shall
not relieve Sanofi of its obligations under Section 2.6(c)(i) for any longer
time than is necessary in light of such emergencies, events or threats.
(d)Wrong Pockets. If either Regeneron or Sanofi becomes aware that (i) any of
the Transferred U.S. Assets has not been transferred to Regeneron or (ii) any
right, record or other asset owned by Sanofi or any of its Affiliates, including
any contract, Trademark, Approval, Domain Name, physical inventory, or
Regulatory Filing (for clarity, other than any Patents, Know-How or Copyrights)
that (A) exclusively relates to the Existing Praluent Product in the Regeneron
Territory, (B) is not contained in the Transferred U.S. Assets and (C) is not
otherwise transferred hereunder or under any Ancillary Agreements, in each case
((i) and (ii)) it shall promptly notify the other Party in writing and the
Parties shall, as soon as reasonably
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practicable, take all actions reasonably necessary to ensure that such right,
asset or record is assigned and transferred, with any reasonably necessary prior
Third Party consent or approval, to Regeneron. Without limiting the foregoing,
if either Regeneron or Sanofi becomes aware that any right, record or other
asset owned or Controlled by Sanofi or any of its Affiliates that relates (but
does not exclusively relate) to the Existing Praluent Product in the Regeneron
Territory and has not otherwise been transferred or made available to Regeneron,
it shall notify the other Party in writing and the Parties shall take all
actions reasonably necessary to provide Regeneron with the benefit of such
right, record or other asset to the extent necessary for the U.S. Praluent
Product Business and Sanofi shall provide Regeneron a copy of such record, which
may be redacted as necessary to remove information that does not relate to the
Existing Praluent Product in the Regeneron Territory. Notwithstanding anything
to the contrary in this Agreement, this Section 2.6(d) sets forth Regeneron’s
sole and exclusive remedy for Sanofi’s inadvertent failure to identify or
transfer any Transferred U.S. Asset to Regeneron under this Section 2.6.
2.7 Transition Costs. Except as expressly set forth in the Praluent Transition
Services Agreement, each Party shall bear its own costs and expenses incurred in
connection with its or its vendors’ and collaborators’ transition of activities
(including any necessary termination of any agreement between such Party or any
of its Affiliates and a Third Party relating to the Commercialization of the
Praluent Products in the Regeneron Territory) and responsibilities pursuant to
this Agreement and the schedules to the Praluent Transition Services Agreement.
2.8 Certain Contract Services. On the request of either Party, the Parties shall
negotiate in good faith the terms of one or more commercial services agreements
(each, a “Praluent Services Agreement”) pursuant to which a Party may, to the
extent provided for under this Agreement, perform certain services for the other
Party with respect to the Praluent Products, including Regeneron providing the
bioanalytical testing services contemplated in Section 4.7 or a Party conducting
certain Other Existing Trials for the other Party. The Parties’ FTE-based costs
and Out-of-Pocket Costs in connection with any such services shall be [* * *].
ARTICLE 3
ALLIANCE MANAGEMENT AND JOINT PRALUENT COMMITTEE
3.1 Alliance Management. Each of the Parties shall appoint a single individual
to act as a single point of contact between the Parties for matters requiring
coordination under this Agreement (each, an “Alliance Manager”) during the
Royalty Term. The Alliance Managers: (a) will be the point of first referral in
all matters of conflict resolution with respect to this Agreement; (b) will
identify and bring issues and potential disputes to the attention of the
Parties’ in a timely manner; (c) will work together to manage and facilitate
communication between the Parties under this Agreement; and (d) shall have such
other responsibilities as the Parties may agree in writing. A Party may replace
the individual serving as its Alliance Manager at any time by notice in writing
to the other Party. The Alliance Managers shall not have final decision-making
authority with respect to any matter under this Agreement.
3.2 Joint Praluent Committee. Within thirty (30) days after the Execution Date,
the Parties shall establish a joint Praluent committee (the “Joint Praluent
Committee” or “JPC”), which shall have the following responsibilities:
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(a)overseeing the performance of the Global Clinical Trials and serving as a
forum for the Parties to discuss matters with respect thereto;
(b)serving as a forum for the Parties to exchange and discuss Existing Trials
Information;
(c)serving as a forum for the Parties to provide the clinical trial and
Commercialization updates contemplated by Section 4.8 and Section 5.3,
respectively; and
(d)performing such other functions as are set forth herein or as the Parties may
mutually agree in writing, except where in conflict with any provision of this
Agreement.
3.3 Composition; Meetings; Disbandment; Limitations on Authority.
(a)Composition. The JPC shall be comprised of three (3) representatives from
each of Sanofi and Regeneron or such other number of representatives from each
Party as the Parties may agree from time to time, provided that the Parties
shall provide an equal number of representatives. A Party may change any of its
representatives at any time by giving written notice to the other Party.
(b)Meetings. The JPC shall meet whenever any Alliance Manager shall make such a
request in writing to the other Party; provided, however, that the JPC shall in
no event meet less frequently than (i) once every [* * *] while any of the
Global Clinical Trials is ongoing or (ii) thereafter, once per Calendar Year or
with such other frequency as may be agreed by the Parties. Each Party shall be
responsible for all of its own costs and expenses of participating in the JPC.
Subject to appropriate confidentiality undertakings where applicable, additional
participants may be invited by any member of the JPC to attend meetings where
appropriate (e.g., representatives of industrial affairs, regulatory affairs or
outside consultants). The Alliance Managers shall (A) set meeting agendas,
provided that the agenda shall include any matter reasonably requested by either
Party, (B) call emergency meetings of the JPC at the request of a Party and (C)
be responsible for recording, preparing and, within a reasonable time, issuing
minutes of the JPC meetings.
(c)Disbandment. Upon completion of all activities in connection with Global
Clinical Trials, either Party shall have the right to request that the other
Party consent to the disbandment of the JPC, such consent not to be unreasonably
withheld, conditioned or delayed. Following disbandment of the JPC, any
coordination activities or updates between the Parties will be supervised and
handled through the Alliance Managers through appropriate written reports or
other materials.
(d)Limitations on Authority. The JPC shall be a consultative body and shall not
have any independent decision-making authority. Without limiting the generality
of the foregoing, the JPC shall not have any authority to: (i) amend, modify, or
waive compliance with this Agreement or any Ancillary Agreements, any of which
shall require mutual written agreement of the Parties; (ii) interpret this
Agreement or any Ancillary Agreement, or determine whether or not a Party has
met its obligations under this Agreement or any Ancillary Agreement
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or whether or not a breach of this Agreement or any Ancillary Agreement has
occurred; or (iii) require either Party to pay, or otherwise expend resources on
any Development, Manufacturing or Commercialization activities.
3.4 Cooperation Generally. As long as a Party, its Affiliates or its or their
Sublicensees Develop, Manufacture or Commercialize the Praluent Compound or any
Praluent Product, such Party shall cooperate in good faith and timely answer any
reasonable request for information, or reasonable solicitation, by the other
Party in connection with such first Party’s Development, Manufacturing or
Commercialization activities, either through or outside the Joint Praluent
Committee, including after the disbandment thereof, to the extent that such
request or solicitation reasonably relates to (a) if the requesting Party is
Regeneron, the U.S. Praluent Product Business or (b) if the requesting Party is
Sanofi, the ROW Praluent Product Business.
ARTICLE 4
DEVELOPMENT
4.1 Development of Praluent Products. Subject to the terms and conditions of
this Agreement and the Praluent Transition Services Agreement and the Praluent
Pharmacovigilance Transition Services Agreement, other than the Global Clinical
Trials or as set forth for the Other Existing Trials on Schedule 4.3, each Party
shall be solely responsible and have decision-making authority for all aspects
of the Development of the Praluent Products undertaken in connection with (a) if
such Party is Regeneron, the U.S. Praluent Product Business or (b) if such Party
is Sanofi, the ROW Praluent Product Business, and shall bear all costs and
expenses related thereto. Without limiting either Party’s obligations under any
Safety Data Exchange Agreement contemplated by Section 6.4 that is then in
effect, and other than with respect to Global Clinical Trials pursuant to
Section 4.2, neither Party shall have the obligation to pursue the Development
of any Praluent Product in its Territory and may discontinue such Development at
its sole discretion.
4.2 Global Clinical Trials.
(a)Schedule 4.2(a) lists the global clinical trials ongoing as of the Transition
Date that the Parties shall jointly complete (the “Global Clinical Trials”) in
accordance with any applicable Global Development Plans (as defined under the
LCA) in effect under the LCA immediately prior to the Transition Date. Each
Party shall use commercially reasonable efforts to carry out the Development
activities assigned to it under such Global Development Plans in connection with
such Global Clinical Trials in a timely manner and conduct all such activities
in compliance with applicable Laws, including Good Practices, and applicable
protocols and budgets for such Global Clinical Trials as in effect as of
immediately prior to the Transition Date. Amendments to any such Global
Development Plan or Global Clinical Trial protocol or budget shall [* * *].
(b)The Parties agree to share Global Trial Costs incurred by or on behalf of
either Party in connection with the Global Clinical Trials after the Transition
Date on a [* * *] basis such that the owing Party will pay such amounts to the
other Party so that, after such payment, each Party has incurred its share of
the Global Trial Costs for the considered period. Within twenty (20) days
following the end of each Calendar Quarter during which a Party incurs
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any Global Trial Costs in connection with a Global Clinical Trial, such Party
shall deliver to the other Party an estimate of such Global Trial Costs. Within
thirty (30) days following the end of each Calendar Quarter during which a Party
incurs any Global Trial Costs in connection with a Global Clinical Trial, such
Party shall deliver to the other Party a report providing detail in respect of
such Global Trial Costs sufficient to enable the other Party to verify the
amount of such Global Trial Costs (a “Global Trial Cost Report”).
(c)Based on the applicable Global Trial Cost Report, the Party having a credit
over the other Party shall submit an invoice to such other Party for the total
amount that such other Party is obligated, pursuant to Section 4.2(b), to pay to
such Party in respect of the Global Trial Costs reflected in such Global Trial
Cost Report, and such other Party shall pay such invoice no later than
forty-five (45) days after receipt thereof. Each such payment shall be subject
to the provisions of Section 8.7 through Section 8.12.
4.3 Other Existing Trials. Schedule 4.3 sets forth, for each Other Existing
Trial that is active as of the Transition Date, (a) whether such Other Existing
Trial shall be continued following the Transition Date or wound-down, (b) which
Party shall have the right or responsibility to continue or wind-down, as
applicable, such Other Existing Trial, (c) the allocation between the Parties of
any costs and expenses with respect to the activities described in clause (b)
and (d) whether sponsorship of such Other Existing Trial will be transferred
from one Party to the other Party. Each Party shall conduct its activities, if
any, with respect to each Other Existing Trial set forth in Schedule 4.3 in
accordance with applicable Law and, in the case of any Other Existing Trial that
is to be wound-down, with due regard for patient safety and the rights of any
subjects that are participants in such Other Existing Trial. Except as otherwise
set forth on Schedule 4.3 with respect to allocation of applicable costs and
expenses, for any Other Existing Trial in respect of which a Party continues to
perform activities on behalf of the other Party after the Transition Date, the
terms and conditions set forth in Sections 4.2(b) and 4.2(c) shall apply mutatis
mutandis to the reporting and payment of FTE-based costs by one Party to the
other Party in respect of such Other Existing Trial. For any Other Existing
Trial for which sponsorship is, as set forth in Schedule 4.3, to be transferred
from one Party to the other Party, each Party shall, at its own cost and
expense, reasonably cooperate with the other Party in order to effect such
transfer, including to notify the relevant hospital authority that such
sponsorship has changed.
4.4 Supply for Certain Investigator-Initiated Studies. Regeneron shall be
responsible for the Manufacture and supply of Finished Clinical Product for use
as clinical trial material in the Other Existing Trials listed on Schedule 4.4
consistent with the practices observed by Regeneron immediately prior to the
Transition Date and in accordance with the terms and conditions applicable to
the supply of such Finished Product prior to the Transition Date.
4.5 Development Records. Each Party shall, and shall cause its Affiliates and
its and their Sublicensees to, maintain, in good scientific manner in accordance
with its internal practices and standard operating procedures, complete and
accurate Development records with respect to activities initiated under the LCA
in respect of the Praluent Compound or the Praluent Products, including with
respect to the Existing Trials; provided that neither Party shall be deemed to
have breached its obligations under this Section 4.5 with respect to periods
prior to the Transition Date to the extent that such obligations would not have
applied to such Party under the LCA. Such records shall (a) include
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sufficient detail to verify compliance with such Party’s obligations under this
Agreement or the LCA, as applicable, (b) be appropriate for patent and
regulatory purposes, (c) be in compliance with applicable Law, (d) properly
reflect all work done and results achieved in the performance of such
Development activities and (e) in the case of such records as relate to a
clinical trial, record only activities relating to such clinical trial and not
include or be commingled with records of activities outside the scope of such
clinical trial. Either Party shall have the right, during normal business hours
and upon reasonable notice, to inspect and copy all such records maintained
pursuant to this Section 4.5 to the extent that such review is consistent with
the licenses and rights of reference granted to such Party under Section 2.1,
Section 2.2 or Section 6.2, as applicable; provided, however, that such Party
shall maintain such records so disclosed in confidence in accordance with
Article 13. Without limiting the foregoing, upon a Party’s reasonable request
for the other Party to provide copies of any particular items within such
records, such other Party shall provide such copies to such first Party to the
extent that doing so is consistent with the licenses and rights of reference
granted to such Party under Section 2.1, Section 2.2 or Section 6.2, as
applicable; provided, however, that such Party shall maintain such copies so
disclosed in confidence in accordance with Article 13. If either Party desires
to no longer maintain any such records in such Party’s custody, then such Party
shall notify the other Party of such desire, and such other Party shall have
thirty (30) days after receipt of such notice to take custody of any such
records at such other Party’s sole cost and expense. If such other Party does
not take custody of such records within such thirty (30)-day period, then such
first Party shall have the right to destroy such records.
4.6 Human Biological Materials. Promptly following the Transition Date, the
Parties shall discuss in good faith procedures and allocation of Out-of-Pocket
Costs for the storage, and provision by one Party to the other Party, of any
biological materials of human origin in the custody of such first Party that
were collected or otherwise obtained in connection with (a) any clinical
activities with respect to any Praluent Product conducted under the LCA prior to
the Transition Date or (b) any Existing Trials (whether prior to or on or after
the Transition Date) (“Human Biological Materials”). Each Party shall, upon the
other Party’s reasonable request and to the extent not prohibited by any
applicable informed consent form or Law, make available to the requesting Party
a reasonable quantity (which shall be determined based on the Parties’ needs
with respect to such materials), of any Human Biological Materials in the
custody of such Party. The Party making such a request to receive Human
Biological Materials shall pay any and all Out-of-Pocket Costs to be incurred by
the shipping Party or its Affiliates in connection with the shipment of the
Human Biological Materials, based on a quote for such shipping services provided
by the shipping Party to the requesting Party. Each Party agrees that it shall
use the Human Biological Materials in compliance with applicable Law and any
applicable informed consent form. If either Party desires to no longer maintain
any Human Biological Materials in such Party’s custody, then, subject to
applicable Law and any applicable informed consent form, such Party shall notify
the other Party of such desire, and such other Party shall have sixty (60) days
after receipt of such notice, or such longer period agreed between the Parties,
to notify such Party that such other Party desires to take custody of such Human
Biological Materials. If such other Party provides such notice within such
period, then the Parties shall, subject to applicable Law and any applicable
informed consent form, cooperate in good faith to transfer such Human Biological
Materials into such other Party’s custody at such other Party’s sole cost and
expense. If such other Party does not provide such notice within such sixty (60)
day period (or such longer period as may be agreed by the Parties), the first
Party shall from and after the end of such period have the right, subject to
applicable Law and any applicable informed consent form, to destroy such Human
Biological Materials.
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4.7 Bioanalytical Testing of Sanofi Samples. Notwithstanding anything to the
contrary in this Agreement (including Section 4.1(b)), as between the Parties,
[* * *].
4.8 Clinical Trial Updates and Notices. Each Party will, in connection with
meetings of the JPC, provide updates on any Existing Trials and notice, to the
extent not previously provided, of any clinical trials in respect of the
Praluent Compound or Praluent Products expected to be initiated by it and its
Affiliates during the following [* * *] period in the Territory. Each such
update shall also contain information regarding (a) the status of Marketing
Approvals of each Existing Praluent Product in the Territory and (b) the results
of any Existing Trial not previously exchanged between the Parties.
ARTICLE 5
COMMERCIALIZATION
5.1 Commercialization of Praluent Products. Subject to the terms and conditions
of this Agreement, each Party shall have the sole responsibility and
decision-making authority with respect to the Commercialization of the Praluent
Products in such Party’s Territory, at such Party’s sole cost and expense. For
clarity, neither Party shall have an obligation to Commercialize any Praluent
Product anywhere in the Territory and neither Party shall be obligated to
participate in any joint or global Commercialization activities for any Praluent
Product. Each Party shall retain the right to attend any medical congress or
similar events in the other Party’s Territory and nothing herein shall be
construed to prohibit either Party from attending any such medical congress or
similar event anywhere in the Territory.
5.2 Booking of Sales and Praluent Product Distribution. As of the Transition
Date, subject to the Praluent Transition Services Agreement, (a) each Party, its
Affiliates and its and their Sublicensees shall invoice and book, and
appropriately record, all sales of Praluent Products in such Party’s Territory
and (b) each Party (or its Affiliate) shall also be responsible for (i) the
distribution of Praluent Products in its Territory and for paying Medicaid (if
applicable) and any and all other governmental rebates that are due and owing
with respect to the Praluent Products distributed by or on behalf of such Party,
its Affiliates or its or their Sublicensees in its Territory, (ii) handling all
other rebates, returns or chargebacks of Praluent Product sold under this
Agreement in its Territory and (iii) handling all aspects of ordering,
processing, invoicing, collection, receivables and returns with respect to
Praluent Product in its Territory.
5.3 Commercialization Updates. Each Party will, in connection with meetings of
the JPC, provide updates on any Commercialization activities undertaken by or on
behalf of such Party with respect to the Praluent Products in [* * *] since the
preceding meeting (or, in the case of the first meeting of the JPC, since the
Transition Date) that such Party reasonably determines could have a material
impact on the other Party’s Development or Commercialization of any Praluent
Product or on any Marketing Approvals in such other Party’s Territory. Without
limiting the foregoing, if a Party plans to withdraw a Marketing Approval for a
Praluent Product in the Regeneron Territory, in the case of Regeneron, or in [*
* *], in the case of Sanofi, such Party shall provide prior written notice of
such withdrawal to the other Party at least [* * *] days in advance of such
withdrawal. For the avoidance of doubt, the updates and notices provided
pursuant to this Section 5.3 are for informational purposes only and do not
grant the receiving Party the right to comment on, approve or object to the
update or notice
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provided by the other Party. A Party’s inadvertent failure to provide to the
other Party any update or notice described in this Section 5.3 shall not be
grounds for termination by such other Party.
5.4 Medical and Consumer Inquiries. Subject to the Praluent Transition Services
Agreement or Praluent Pharmacovigilance Transition Services Agreement, and
except to the extent related to Development responsibilities allocated to a
Party pursuant to Article 4, each Party shall have sole responsibility for
responding to medical questions or inquiries from members of the medical and
paramedical professions and consumers regarding Praluent Products in such
Party’s Territory. Subject to the Praluent Pharmacovigilance Transition Services
Agreement or Praluent Transition Services Agreement, each Party shall refer to
the other Party all such questions or inquiries that it receives about any
Praluent Product pertaining to the other Party’s Territory (other than with
respect to the Development responsibilities allocated to such first Party
pursuant to Article 4) or relating to Development responsibilities allocated to
such other Party pursuant to Article 4.
5.5 Market Exclusivity Extensions. Each Party shall have the exclusive right but
not the obligation to maintain, and, to the extent available, legally extend,
the period of time during which, in any country in such Party’s Territory, (a)
such Party, or any of its Affiliates or its or their Sublicensees, has the
exclusive legal right, whether by means of a Patent or through other rights
granted by a Governmental Authority in such country, to Commercialize the
Praluent Products in such country, and (b) no generic equivalent of any Praluent
Product is marketed in such country.
5.6 Promotional Materials.
(a)Without limiting Section 2.1 or Section 2.2, each Party shall have the right
to use any Promotional Materials in such Party’s possession as of the Transition
Date (or, in the case of Regeneron, that are transferred to Regeneron as part of
the Transferred U.S. Assets) solely for the purpose of Commercializing the
Praluent Products in such Party’s Territory.
(b)Except with respect to any Transferred Promotional Materials, each Party
shall be responsible, at its sole cost and expense, for preparing and producing
Promotional Materials for use in its Territory and such Promotional Materials
shall bear the corporate name and logo of the promoting Party only.
(c)For clarity, neither Party shall have any right or obligation to review
Promotional Materials of the other Party and neither Party shall be entitled to
reproduce, distribute, create derivative works based on (including translations
thereof), publicly perform, publicly display or otherwise use any Promotional
Materials, educational or training materials or other materials relating to the
Commercialization of the Praluent Products that are created by or on behalf of
the other Party after the Transition Date.
5.7 Market Access; Pricing Approvals; Re-Sale Price. Each Party shall be solely
responsible for market access activities and shall be free to file for NDCs and
Pricing Approvals and determine the price(s) at which Praluent Products shall be
sold in such Party’s Territory, subject to any NDCs, Pricing Approvals or other
requirements imposed by any applicable Law.
5.8 Cross-Territory Sales. During the Royalty Term:
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(a)Each Party undertakes and covenants, for itself, its Affiliates,
(sub)licensees and distributors not to directly solicit, advertise, sell,
distribute, consign for sale, or otherwise promote the Praluent Products outside
its Territory.
(b)Each Party shall use commercially reasonable efforts to ensure that the
quantities of Praluent Product sold in its Territory are not exported outside
its Territory.
(c)Without limiting the generality of the foregoing, neither Party shall sell
any quantity of Praluent Product to a distributor if it knows, or has reason to
believe, that such distributor intends to export such Praluent Product into the
other Party’s Territory or otherwise intends to facilitate the use of such
Praluent Product outside its Territory.
(d)In the event that Regeneron, its Affiliates or its or their Sublicensees [* *
*]. For clarity, this Section 5.8(d) does not grant Regeneron, its Affiliates
and its and their Sublicensees any license rights under the Sanofi Background
Intellectual Property, the Sanofi Core Intellectual Property or Sanofi’s
interest in the Joint Intellectual Property in the Sanofi Territory beyond the
license grants expressly set forth in Section 2.2. [* * *]. For clarity, this
Section 5.8(d) does not grant Sanofi, its Affiliates and its and their
Sublicensees any license rights under the Regeneron Background Intellectual
Property, the Regeneron Core Intellectual Property or Regeneron’s interest in
the Joint Intellectual Property in the Regeneron Territory beyond the license
grants expressly set forth in Section 2.1.
ARTICLE 6
REGULATORY AFFAIRS
6.1 Ownership of Approvals and Regulatory Filings. Except to the extent
prohibited by applicable Law or as provided in any Praluent Supply Agreement, as
between the Parties, each Party shall own all Approvals and Regulatory Filings
with respect to its Manufacture, Development or Commercialization of Praluent
Products (including the Praluent Compound) conducted in accordance with the
terms and conditions of this Agreement (including the licenses and other rights
granted to such Party).
6.2 Rights of Reference; Sanofi ROR Authorizations; DAI Design History File;
Separate INDs.
(a)Sanofi and its Affiliates shall have, and Regeneron (on behalf of itself and
its Affiliates) hereby grants to Sanofi and its Affiliates, the right to access
and reference (with the right to grant further rights of reference pursuant to
Section 2.3) all regulatory documentation (including all Regulatory Filings and
Approvals) Controlled by Regeneron (or its Affiliates) that is related to any
Existing Praluent Product for any Existing Indication solely as necessary to
exercise Sanofi’s rights under the license grants set forth in Section 2.1 or
necessary or useful to obtain Approval for any of Sanofi’s or its Affiliates’
products for use in combination with any Existing Praluent Product. Promptly
upon the request of Sanofi, Regeneron or its Affiliate shall, to the extent such
request is consistent with the foregoing rights to access and reference, submit
a letter of authorization to the applicable Regulatory Authority (and take such
actions or make such other filings) in order to permit any such regulatory
documentation (including all
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Regulatory Filings and Approvals) to be incorporated by reference by Sanofi, its
Affiliates or its or their Sublicensees in their Regulatory Filings.
(b)Regeneron and its Affiliates shall have, and Sanofi (on behalf of itself and
its Affiliates) hereby grants to Regeneron and its Affiliates, the right to
access and reference (with the right to grant further rights of reference
pursuant to Section 2.3) all regulatory documentation (including all Regulatory
Filings and Approvals) Controlled by Sanofi (or its Affiliates) that is related
to any Existing Praluent Product for any Existing Indication solely as necessary
to exercise Regeneron’s rights under the license grants set forth in Section 2.2
or necessary or useful to obtain Approval for any of Regeneron’s or its
Affiliates’ products for use in combination with any Existing Praluent Product.
Promptly upon the request of Regeneron, Sanofi or its Affiliate shall, to the
extent such request is consistent with the foregoing rights to access and
reference, submit a letter of authorization to the applicable Regulatory
Authority (and take such actions or make such other filings) in order to permit
any such regulatory documentation (including all Regulatory Filings and
Approvals) to be incorporated by reference by Regeneron, its Affiliates or its
or their Sublicensees in their Regulatory Filings.
(c)Sanofi ROR Authorizations; DAI Design History File.
(i) With respect to each Sanofi ROR Authorization on which the BLA relies that
is not partially assignable or transferable to Regeneron for use in connection
with the U.S. Praluent Product Business (or entirely to the extent exclusively
relating to the U.S. Praluent Product Business) without the consent of a Third
Party, Sanofi shall use diligent efforts to facilitate Regeneron obtaining a
corresponding right to access and reference directly from the applicable Third
Party.
(ii) Without limiting Section 6.2(c)(i), if any Sanofi ROR Authorization that is
necessary or useful for the Manufacture or use of [* * *]. Promptly upon the
request of Regeneron, Sanofi or its Affiliate shall, to the extent such request
is consistent with the foregoing rights to access and reference, submit a letter
of authorization to the applicable Regulatory Authority (and take such actions
or make such other filings) as necessary in order to permit any such regulatory
documentation to be incorporated by reference by Regeneron, its Affiliates or
its or their Sublicensees in their Regulatory Filings.
(iii) For the avoidance of doubt, nothing in this Section 6.2(c) shall be
construed to require Sanofi to transfer to Regeneron [* * *].
(d)Subject to the rights of reference granted under this Section 6.2, each Party
shall be solely responsible for obtaining and maintaining any IND or other
Approval required for such Party to conduct any Development activities performed
by such Party, including with respect to any Development activities permitted to
be conducted in the other Party’s Territory, it being understood, however, that
Regeneron shall be responsible for maintaining the IND or any other Transferred
Approvals required for either Party to conduct Development activities relating
to or in connection with the Existing Trials.
6.3 Regulatory Activities.
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(a)Subject to the remainder of this Section 6.3 and Section 13.3(c) and subject
to the Praluent Transition Services Agreement and the Praluent Pharmacovigilance
Transition Services Agreement, each Party shall be solely responsible for, and
shall have sole decision-making authority with respect to, all regulatory
strategy and actions, including preparing communications and filings with and
submissions (including supplements and amendments thereto) to, and attending
meetings with, the applicable Regulatory Authority(ies), in each case with
respect to such Party’s Development and Commercialization activities conducted
in accordance with the terms and conditions of this Agreement (including the
licenses and other rights granted to such Party), provided that Regeneron may
not, until the [* * *] anniversary of the Transition Date, [* * *]. Each Party
shall provide the other Party (i) copies of all material submissions with
respect to any Praluent Product to the FDA, in respect of Regeneron’s
submissions, and the EMA or PMDA, in respect of Sanofi’s submissions, in each
case reasonably in advance of such Party’s submission thereof and (ii) copies of
all material correspondence with respect to any Praluent Product received from
such Regulatory Authorities promptly following receipt of such correspondence.
If a Party becomes aware that a copy of any such submission or correspondence
has not been provided in accordance with the foregoing sentence, it shall
promptly notify the other Party in writing and the applicable Party shall, as
soon as reasonably practicable, provide such copy to the Party to whom such copy
is owed. Notwithstanding anything to the contrary in this Agreement, the
immediately preceding sentence sets forth each Party’s sole and exclusive remedy
for the other Party’s inadvertent failure to provide such copies. With respect
to any filing, correspondence or communications by a Party with a Regulatory
Authority anywhere in the Territory, including submission of additional data
regarding a Praluent Product, that would reasonably be expected to materially
impact (i) if the other Party is Regeneron, the U.S. Praluent Product Business
or (ii) if the other Party is Sanofi, the ROW Praluent Product Business, in
either case ((i) or (ii)), the Parties shall cooperate in good faith to
coordinate with each other to ensure consistent messaging with respect thereto.
(b)Subject to the remainder of this Section 6.3(b) and Section 13.3(c) and
subject to any applicable Praluent Supply Agreement, each Party shall be solely
responsible for, and shall have sole decision-making authority with respect to,
all regulatory strategy and actions, including preparing communications and
filings with and submissions (including supplements and amendments thereto) to,
and attending meetings with, the applicable Regulatory Authority(ies) anywhere
in the Territory, in each case, with respect to such Party’s Manufacturing
activities with respect to any Praluent Compound or Praluent Product. For
purposes of this Section 6.3(b), “Manufacturing Party” shall mean, (i) Regeneron
for so long as Regeneron is Manufacturing and supplying Formulated Drug
Substance to Sanofi pursuant to the Praluent Substance Supply Agreement and (ii)
Sanofi for so long as Sanofi is Manufacturing and supplying Finished Product to
Regeneron pursuant to the Finished Product Supply Agreement. Notwithstanding the
foregoing, with respect to each Manufacturing Party, for so long as such
Manufacturing Party is a Manufacturing Party, the other Party (the
“Non-Manufacturing Party”) shall consult with the Manufacturing Party with
respect to any portion of any Regulatory Filing, submission or other
communication (including any response to a question from a Regulatory Authority)
anywhere in the Territory by or on behalf of the Non-Manufacturing Party
relating to the Manufacturing Party’s Manufacture of, with respect to Regeneron
as the Manufacturing Party, Formulated Drug Substance pursuant to the Praluent
Substance Supply Agreement, and
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with respect to Sanofi as the Manufacturing Party, Finished Product pursuant to
the Finished Product Supply Agreement and shall provide a draft thereof to the
Manufacturing Party (including an English translation if such draft is not in
English) at least thirty (30) days (or, with respect to a submission or
communication other than a Regulatory Filing, ten (10) days or such shorter
period as may be required with respect to any question from a Regulatory
Authority) prior to the date that such submission or communication is required
to be made to the applicable Regulatory Authority for the Manufacturing Party’s
review and comment and shall consider in good faith any comments timely provided
by the Manufacturing Party to the Non-Manufacturing Party in respect of such
draft.
6.4 Pharmacovigilance and Safety Data Exchange. To ensure continuity in the
exchange of necessary safety and pharmacovigilance information regarding the
Praluent Products Developed and Commercialized under this Agreement and prompt
communication of notifications and compliance with reporting obligations to
Regulatory Authorities, the Parties have entered, on the Execution Date, into
the Praluent Pharmacovigilance Transition Services Agreement and the new Safety
Data Exchange Agreement in the form attached hereto as Exhibit 6.4 (the “Safety
Data Exchange Agreement”). Subject to the terms and conditions of the Praluent
Pharmacovigilance Transition Services Agreement, the Parties shall comply with
their respective obligations and responsibilities assigned under the Safety Data
Exchange Agreement.
6.5 Regulatory Inspection or Audit. Each Party shall cooperate with the other
Party and any Regulatory Authority in the Territory during an inspection or
audit to the extent relating to (a) any of the Existing Trials or (b) any other
clinical Development under the LCA in respect of the Praluent Compound or the
Praluent Products, in each case 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 such 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
the Praluent Products, provided that the other Party shall have the right to
review and comment on such responses, except to the extent such responses
contain information for which the Party in receipt of the observation owes an
obligation of confidentiality to a Third Party, and such Party shall consider in
good faith the comments made by such other Party. In the event that the Parties
disagree concerning the form or content of a response, the Party that received
the observations shall decide the appropriate form and content of the response.
Regulatory inspections and audits pertaining to either Party’s Manufacturing
facilities shall be governed by the Praluent Substance Supply Agreement or the
Finished Product Supply Agreement, as applicable. Without limiting the
foregoing, each Party (and its Third Party subcontractors) shall, for so long as
Manufacture under an applicable Praluent Supply Agreement is ongoing, notify the
other Party within twenty-four (24) hours after 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
Praluent Product by or on behalf of such Party for such other Party under such
Praluent Supply Agreement.
6.6 Recalls and Other Corrective Actions.
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(a)Notice. Each Party shall notify the other Party promptly (but in no event
later than forty-eight (48) hours) following its determination that any event,
incident or circumstance has occurred that may result in the need for a recall,
market suspension or market withdrawal of any Praluent Product in such Party’s
Territory that (i) would reasonably be expected to materially impact (A) if such
other Party is Regeneron, the U.S. Praluent Product Business or (B) if such
other Party is Sanofi, the ROW Praluent Product Business, (ii) relates to
Praluent Product sold before the Transition Date or (iii) (A) if such other
Party is Regeneron, is being implemented with respect to Formulated Drug
Substance supplied by Regeneron to Sanofi under the Praluent Substance Supply
Agreement or (B) if such other Party is Sanofi, is being implemented with
respect to Finished Product supplied by Sanofi to Regeneron under the Finished
Product Supply Agreement (any recall, market suspension or market withdrawal
described in clauses (i), (ii) or (iii), a “Selected Recall”), and, in any case
((i), (ii) or (iii)), shall include in such notice the reasoning behind such
determination and any supporting facts.
(b)Implementation. As between the Parties, a Party shall have the right to make
the final determination whether to voluntarily implement, and shall have
operational responsibility for implementation of, any recall, market suspension
or market withdrawal of Praluent Product in its Territory; provided that
operational responsibility for implementation of any recall, market suspension
or market withdrawal of any Praluent Product in the Regeneron Territory bearing
Sanofi’s NDC shall be governed by the Praluent Transition Services Agreement or
the Praluent Pharmacovigilance Transition Services Agreement; provided further
that, prior to any implementation of a Selected Recall, such Party shall consult
with the other Party and shall consider the other Party’s comments in good
faith. If a recall, market suspension or market withdrawal is mandated by a
Regulatory Authority in a Party’s Territory, as between the Parties, such Party
shall have the right to make the final determination to implement such recall,
market suspension or market withdrawal.
(c)Costs. For all recalls, market suspensions or market withdrawals undertaken
pursuant to this Section 6.6, (i) to the extent such recall, market suspension
or market withdrawal is attributable to conduct occurring prior to the
Transition Date, the Recall Costs of any recall, market suspension or market
withdrawal will be shared in the same proportions as if such Recall Costs were
Other Shared Expenses (as defined in the LCA) under the LCA as of immediately
prior to the Transition Date and (ii) subject to any further allocation under
any applicable Praluent Supply Agreement, to the extent such recall, market
suspension or market withdrawal is attributable to conduct occurring after the
Transition Date and to the extent not constituting Third Party Claims covered by
Section 14.1, the Recall Costs of any recall, market suspension or market
withdrawal will be borne [* * *]. The payment of such Recall Costs shall be
subject to the provisions of Section 8.7 through Section 8.12, except to the
extent addressed in the Praluent Transition Services Agreement or the Praluent
Pharmacovigilance Transition Services Agreement, in which case it shall be
subject to the applicable provisions thereof.
(d)Correspondence or Public Announcements. Notwithstanding the provisions of
this Article 6 or Article 13, each Party shall provide the other Party with
copies of any proposed correspondence with Regulatory Authorities or any
proposed public announcement, in each case, related to any voluntary or mandated
recall, market suspension or
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market withdrawal of any Praluent Product in such Party’s Territory for the
other Party’s review and comment prior to such Party making or disclosing any
such correspondence or public announcement if such recall, market suspension or
market withdrawal constitutes a Selected Recall. Without limiting the foregoing,
each Party shall provide the other Party with copies of any correspondence sent
to or received from Regulatory Authorities or any issued public announcement, in
each case, related to any Selected Recall.
(e)Miscellaneous. Each Party shall consider any comments made by the other Party
pursuant to this Section 6.6 in good faith. Notwithstanding anything herein to
the contrary, in the event of any inconsistency between this Section 6.6 and the
terms and conditions of any applicable quality agreement that is an exhibit to
any Praluent Supply Agreement or the Safety Data Exchange Agreement, the terms
of such quality agreement or Safety Data Exchange Agreement, as applicable,
shall control.
ARTICLE 7
TECHNOLOGY TRANSFER - MANUFACTURING AND SUPPLY
7.1 Manufacturing Generally. Notwithstanding the terms and conditions of the
Praluent Supply Agreements, it is the Parties’ intention to transfer
responsibility for the Manufacture of all forms of Praluent Products (and of the
constituents thereof) to (a) Sanofi for all clinical and commercial requirements
of Praluent Products with respect to Development and Commercialization
activities of Sanofi, its Affiliates and its and their Sublicensees and (b)
Regeneron for all clinical and commercial requirements of Praluent Products with
respect to Development and Commercialization by Regeneron, its Affiliates and
its and their Sublicensees, in each case ((a) and (b)) pursuant to the terms and
conditions of this Agreement. The Parties shall cooperate diligently toward that
goal in accordance with the terms and conditions of [* * *] the Drug Substance
Tech Transfer Plan referred to in Section 7.3.
7.2 [* * *].
(a)[* * *]. Each Party shall appoint a technology transfer coordinator to serve
as a single point of contact with respect to the Parties’ activities [* * *]. No
later than [* * *] prior to the date on which Regeneron desires to initiate the
Finished Product technology transfer, Regeneron shall notify Sanofi in writing
regarding Regeneron’s choice of Manufacturing site or contract manufacturing
organization for the Manufacture by or on behalf of Regeneron of Finished
Product from Formulated Drug Substance (“Regeneron Manufacturing Site Notice”).
Within [* * *] days following Sanofi’s receipt of the Regeneron Manufacturing
Site Notice, the Parties shall [* * *]. Each Party shall use commercially
reasonable efforts to perform its activities [* * *] within the anticipated
timelines, and Regeneron shall use commercially reasonable efforts to enable it
to accept the Finished Product technology transfer, including obtaining and
making available such information, personnel, products, materials, services,
facilities and other resources as reasonably necessary to implement such
technology transfer. Provided that Sanofi has complied with its obligations
under this Section 7.2(a) [* * *], Sanofi shall not be liable to Regeneron for
Regeneron’s inability to Manufacture Finished Product from Formulated Drug
Substance [* * *]. Except to the extent specifically set forth in [* * *], the
Praluent Transition Services Agreement, the Praluent Pharmacovigilance
Transition Services Agreement or this Section 7.2(a), Sanofi shall have no
obligation to provide transition
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or other support with respect to the transfer of Finished Product Manufacture
(from Formulated Drug Substance) from Sanofi to Regeneron or its designee.
(b)[* * *], upon Regeneron’s request, Sanofi shall use commercially reasonable
efforts to facilitate an introduction and an initial discussion between
Regeneron and any Third Party with which Sanofi or its Affiliate has a material
Third Party supplier relationship that pertains to the Finished Product
(including any delivery devices, e.g., an autoinjector).
7.3 Drug Substance Tech Transfer Plan.
(a)The Parties acknowledge that the activities necessary to enable Sanofi to
Manufacture or have Manufactured Formulated Drug Substance have been
substantially advanced by the Parties as of the Transition Date and, except for
the activities set forth in the Drug Substance Tech Transfer Plan, Sanofi has
received the Formulated Drug Substance technology transfer as of the Transition
Date. Schedule 7.3(a) is the Manufacturing technology transfer plan setting
forth a high-level summary of the Parties’ remaining activities necessary for
Sanofi to Manufacture or have Manufactured Formulated Drug Substance, as well as
the anticipated starting date and timelines for the completion of such
activities (the “Drug Substance Tech Transfer Plan”). Each Party shall appoint a
technology transfer coordinator to serve as a single point of contact with
respect to the Parties’ activities under the Drug Substance Tech Transfer Plan.
Each Party shall use commercially reasonable efforts to perform its activities
under the Drug Substance Tech Transfer Plan within the anticipated timelines,
and Sanofi shall use commercially reasonable efforts to enable it to accept the
remainder of the Formulated Drug Substance technology transfer, including
obtaining and making available such information, personnel, products, materials,
services, facilities and other resources as reasonably necessary to implement
such technology transfer. Provided that Regeneron has complied with its
obligations under this Section 7.3(a) and the Drug Substance Tech Transfer Plan,
Regeneron shall not be liable to Sanofi for Sanofi’s inability to Manufacture
Formulated Drug Substance following completion of the activities contemplated
under the Drug Substance Tech Transfer Plan. Except to the extent specifically
set forth in the Drug Substance Tech Transfer Plan, the Praluent Transition
Services Agreement, the Praluent Pharmacovigilance Transition Services Agreement
or this Section 7.3, Regeneron shall have no obligation to provide transition or
other support with respect to the transfer of Formulated Drug Substance
Manufacture to Sanofi.
(b)As part of the Drug Substance Tech Transfer Plan, upon Sanofi’s request,
Regeneron shall use commercially reasonable efforts to facilitate an
introduction and an initial discussion between Sanofi and any Third Party with
which Regeneron or its Affiliate has a material Third Party supplier
relationship that pertains to the Formulated Drug Substance.
7.4 Technology Transfer Costs.
(a)Subject to Section 7.4(b), each Party shall bear all of its and its
Affiliates’ costs and expenses incurred in connection with its assigned
activities under [* * *] the Drug Substance Tech Transfer Plan (each, a “Tech
Transfer Plan” where each Party transferring the Manufacturing process under a
Tech Transfer Plan shall be a “Transferor” and each Party implementing such
Manufacturing process under a Tech Transfer Plan shall be a “Transferee”).
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(b)With respect to each Tech Transfer Plan, the Transferee shall, pursuant to
Section 7.4(d), reimburse to the Transferor (i) [* * *] percent ([* * *]%) of
the Transferor’s Out-of-Pocket Costs incurred by the Transferor and its
Affiliates in connection with the Transferor’s assigned activities under such
Tech Transfer Plan and (ii) (A) [* * *] percent ([* * *]%) of the Transferor’s
Tech Transfer FTE Costs incurred by the Transferor and its Affiliates in
connection with the Transferor’s assigned activities under such Tech Transfer
Plan during [* * *] and (B) thereafter, [* * *] percent ([* * *]%) of the
Transferor’s Tech Transfer FTE Costs incurred by the Transferor and its
Affiliates in connection with the Transferor’s assigned activities under such
Tech Transfer Plan.
(c)Within ten (10) days following the end of each Calendar Quarter during which
the Transferor or any of its Affiliates incurs any Out-of-Pocket Costs or Tech
Transfer FTE Costs in connection with a Tech Transfer Plan for which the
Transferee has an obligation to reimburse the Transferor pursuant to Section
7.4(b), the Transferor shall deliver to the Transferee an estimate of such
Out-of-Pocket Costs or Tech Transfer FTE Costs. Within thirty (30) days
following the end of each Calendar Quarter during which the Transferor or any of
its Affiliates incurs any Out-of-Pocket Costs or Tech Transfer FTE Costs in
connection with a Tech Transfer Plan for which the Transferee has an obligation
to reimburse the Transferor pursuant to Section 7.4(b), the Transferor shall
deliver to the Transferee a report providing detail in respect of such
Out-of-Pocket Costs or Tech Transfer FTE Costs sufficient to enable the
Transferee to verify the amount of such Out-of-Pocket Costs or Tech Transfer FTE
Costs (a “Technology Transfer Cost Report”).
(d)Simultaneous with the delivery of a Technology Transfer Costs Report by the
Transferor to the Transferee, the Transferor shall submit an invoice to the
Transferee for the total amount that the Transferee is obligated, per Section
7.4(b), to reimburse to the Transferor in respect of the Out-of-Pocket Costs and
Tech Transfer FTE Costs reflected in such Technology Transfer Costs Report, and
the Transferee shall pay such invoice no later than forty-five (45) days after
receipt thereof. Each such payment shall be subject to the provisions of Section
8.7 through Section 8.12.
(e)For the avoidance of doubt, any Out-of-Pocket Costs referred to in this
Section 7.4 will be [* * *].
7.5 Praluent Supply Agreements. Simultaneously with the execution of this
Agreement, the Parties (or their Affiliates) have entered into supply
agreements, under which:
(a)Sanofi or its Affiliates shall procure Formulated Drug Substance from
Regeneron or its Affiliates (the “Praluent Substance Supply Agreement”); and
(b)Subject to Section 4.4, Regeneron or its Affiliates shall procure Finished
Product from Sanofi or its Affiliates (the “Finished Product Supply Agreement”).
7.6 Back-up Supply. The Parties acknowledge that the Praluent Substance Supply
Agreement will address the Parties’ rights and obligations in respect of back-up
supply of Formulated Drug Substance by Regeneron to Sanofi during the term of
the Praluent Substance Supply Agreement. 
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If after the term of the Praluent Substance Supply Agreement, (a) Sanofi
experiences [* * *], (b) Sanofi is [* * *] and (c) Regeneron is [* * *], then,
upon Sanofi’s reasonable request (which request shall include Sanofi’s requested
quantities of, and delivery dates for, Formulated Drug Substance manufactured [*
* *], “Back-Up Request”), Regeneron shall consider Sanofi’s Back-Up Request and
within [* * *] Business Days of receiving such request, Regeneron shall [* * *],
and (x) if Regeneron [* * *] and (y) if Regeneron [* * *].
7.7 Regeneron Cell Media.
(a)As long as Sanofi is complying with its obligations under Section 2.4(b) and
Section 13.3(c), Regeneron hereby grants Sanofi the rights [* * *].
(b)Sanofi shall not, and shall cause its Affiliates not to, (i) use Regeneron
Cell Media for any purpose other than to Manufacture the Formulated Drug
Substance for purposes of Commercializing Praluent Products in the Sanofi
Territory (including any Development in support of such Commercialization) or
(ii) transfer Regeneron Cell Media to any Third Party other than a Third Party
contract manufacturer approved by Regeneron pursuant to Section 2.3(c).
7.8 Cell Banks.
(a)The Parties acknowledge that the transfer of any vials of Praluent Master
Cell Bank or Praluent Working Cell Bank from Regeneron to Sanofi will be carried
out as and to the extent set forth in the Drug Substance Tech Transfer Plan and,
notwithstanding anything herein to the contrary, at [* * *].
(b)Sanofi shall not, and shall cause its Affiliates not to, (i) use any Praluent
Working Cell Bank or Praluent Master Cell Bank (or any component thereof) for
any purpose other than to Manufacture the Formulated Drug Substance for purposes
of Commercializing Praluent Products in the Sanofi Territory (including any
Development in support of such Commercialization) or (ii) transfer any Praluent
Working Cell Bank or Praluent Master Cell Bank to any Third Party other than a
Third Party contract manufacturer approved by Regeneron pursuant to Section
2.3(c).
(c)If Regeneron desires to no longer maintain the Praluent Master Cell Bank,
then Regeneron shall notify Sanofi of such desire, and Sanofi shall have thirty
(30) days after receipt of such notice to take custody of the Praluent Master
Cell Bank at its sole cost and expense. If Sanofi does not take custody of the
Praluent Master Cell Bank within such thirty (30) day period, then Regeneron
shall have the right to destroy it.
7.9 Manufacturing Transition Team.
(a)Formation and Responsibilities. Within thirty (30) days after the Execution
Date, the Parties shall establish a Manufacturing transition team (the
“Manufacturing Transition Team”), which shall have the following
responsibilities: (i) overseeing forecasting, ordering and order fulfilment
under the Praluent Supply Agreements and serving as a forum for
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the Parties to discuss matters with respect thereto; (ii) overseeing the
performance of the Tech Transfer Plans; and (iii) serving as a forum for the
Parties to discuss other Manufacturing-related topics, such as and not limited
to manufacturing changes or new product launches for Praluent Products.
(b)Composition; Meetings; Disbandment; Limitations on Authority.
(i) Composition. The Manufacturing Transition Team shall be comprised of such
number of representatives from each Party as the Parties may agree from time to
time, provided that the Parties shall provide an equal number of
representatives. A Party may change any of its representatives at any time by
giving written notice to the other Party.
(ii) Meetings. The Manufacturing Transition Team shall adopt such standing rules
regarding its meetings (including regarding the frequency of such meetings) as
shall be necessary for its work, to the extent that such rules are not
inconsistent with this Agreement.
(iii) Disbandment. Upon completion of all activities in connection with the
Praluent Supply Agreements and the Tech Transfer Plans, either Party shall have
the right to request that the other Party consent to the disbandment of the
Manufacturing Transition Team, such consent not to be unreasonably withheld,
conditioned or delayed. The Manufacturing Transition Team will in any case be
disbanded on the [* * *] anniversary of the Transition Date.
(iv) Limitations on Authority. The Manufacturing Transition Team shall be a
consultative body and shall not have any independent decision-making authority.
ARTICLE 8
PAYMENTS; BOOKS & RECORDS; AUDITS
8.1 Royalties to Regeneron.
(a)Royalties Generally. In consideration of the licenses granted by Regeneron to
Sanofi pursuant to Article 2 of this Agreement, Sanofi shall pay to Regeneron a
five percent (5%) royalty on Net Sales of the Praluent Royalty Products in the
Sanofi Territory, paid on a Calendar Quarter basis.
Any payments made under this Agreement are exclusive of VAT, GST, sales and use
tax, or similar tax, which shall be added thereon as applicable.
(b)Royalty Payment Term. The above royalties shall be payable from the
Transition Date until the [* * *] anniversary of the Transition Date (the
“Royalty Term”), irrespective of [* * *]. By way of illustration, [* * *].
(c)Royalty Deductions. During the Royalty Term, Sanofi shall have the right to
deduct from any royalty payment made to Regeneron pursuant to Section 8.1(a)
with respect to a country in the Sanofi Territory in any given Calendar Quarter
[* * *] percent ([* * *]%) of
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any payments in respect of the Praluent Compound that are owed by Sanofi [* *
*]; provided, however, that the foregoing shall not apply to any payments owed
by Sanofi [* * *] with respect to which Regeneron has already borne or
reimbursed [* * *] percent ([* * *]%) under Section 14.1(c)(i)(B) of this
Agreement. Subject to Section 14.1(c), Sanofi shall bear [* * *] percent ([* *
*]%) of any other payment owed by Sanofi, its Affiliates or its or their
Sublicensees [* * *] under any New Sanofi License, or any other license or
settlement, entered into by Sanofi, its Affiliates or its or their Sublicensees
in connection with their Development, Manufacture or Commercialization of any
Praluent Royalty Product under this Agreement or otherwise.
(d)Royalty Floor. Notwithstanding Section 8.1(c), no reduction in, or deduction
from royalties hereunder shall cause the royalty payable by Sanofi hereunder for
a given Calendar Quarter for a given country to be less than [* * *] percent ([*
* *]%) of the royalty payment that would otherwise be payable under Section
8.1(a) for such Calendar Quarter and such country absent such deductions,
provided that if any portion of any such reductions or deductions are not, due
to the operation of this Section 8.1(d), fully applied in any particular
Calendar Quarter, such portion may be used in subsequent Calendar Quarters for
such country until exhausted.
(e)Blended Royalty. Sanofi acknowledges that (a) the Regeneron Manufacturing
Know-How and the Know-How included in the Regeneron Core Intellectual Property,
Joint Intellectual Property and the Regeneron Background Intellectual Property
licensed to Sanofi are proprietary and valuable and that without such Know-How,
Sanofi would not be able to obtain and maintain Approvals with respect to the
Praluent Royalty Products in the Sanofi Territory, (b) such Approvals may allow
Sanofi to obtain and maintain regulatory exclusivity with respect to the
Praluent Royalty Products in the Sanofi Territory, (c) access to such Know-How
has provided Sanofi with a competitive advantage in the marketplace beyond the
exclusivity afforded by the Patents licensed to Sanofi pursuant to Section 2.1
and (d) the royalty set forth in Section 8.1(a) is, in part, intended to
compensate Regeneron for such competitive advantage. The Parties agree that the
royalty rate set forth in Section 8.1(a) reflects an efficient and reasonable
blended allocation of the value provided by Regeneron to Sanofi.
8.2 No Royalty to Sanofi. No royalties shall be payable by Regeneron to Sanofi
on Net Sales of Praluent Royalty Product by Regeneron, its Affiliates and its
and their Sublicensees in the Regeneron Territory. Regeneron shall bear one
hundred percent (100%) of any payment owed by Regeneron, its Affiliates or its
or their Sublicensees to Third Parties under any New Regeneron License, or any
other license or settlement, entered into by Regeneron, its Affiliates or its or
their Sublicensees in connection with any Development, Manufacture or
Commercialization of any Praluent Royalty Product by Regeneron, its Affiliates
or its or their Sublicensees that occurs on or after the Transition Date under
this Agreement.
8.3 Reporting. During the Royalty Term, Sanofi shall prepare and deliver
electronically to Regeneron the periodic reports specified below:
(a)Within [* * *] days following the end of each Calendar Quarter, Sanofi shall
deliver to Regeneron a non-binding estimate of aggregate Net Sales for all
Praluent Royalty Products for such Calendar Quarter; and
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(b)Within [* * *] days following the end of each Calendar Quarter, Sanofi shall
prepare and deliver to Regeneron a written report setting forth, on a
country-by-country basis in the Sanofi Territory for such Calendar Quarter, (i)
the Net Sales of each Praluent Royalty Product, (ii) royalties payable in
respect of Praluent Royalty Product and (iii) where applicable, any royalty
deductions in respect of Praluent Royalty Product under Section 8.1(c) (such
report, a “Royalty Report”).
Unless otherwise agreed by Regeneron, the financial data in the reports will
include calculations in local currency and United States Dollars.
8.4 Royalty Payments. Following delivery of a Royalty Report for a particular
Calendar Quarter, Regeneron shall submit an invoice to Sanofi for the amount of
royalties thereunder as per the directions set forth in Schedule 8.4 and Sanofi
shall pay all royalties due to Regeneron hereunder in respect of such Calendar
Quarter no later than thirty (30) days after the receipt of Regeneron’s invoice
therefor.
8.5 Transferred Inventory. In consideration of the transfer by Sanofi to
Regeneron of the Transferred Inventory, Regeneron shall pay to Sanofi the
corresponding price(s) per unit set forth on Schedule 8.5 (the “Inventory
Payment”). Simultaneous with the transfer by Sanofi to Regeneron of the
Transferred Inventory pursuant to Section 2.6, Sanofi shall send Regeneron an
invoice for the amount of the Inventory Payment, and Regeneron shall pay Sanofi
the Inventory Payment no later than fifteen (15) days after receipt of such
invoice. The payment of the Inventory Payment shall be subject to the provisions
of Section 8.7 through Section 8.12.
8.6 Allocation of Sales Deduction Costs. Liability with respect to any Sales
Deduction Costs (including, for clarity, with respect to any pre-Transition Date
sales) incurred by either Party or any of its Affiliates after the Transition
Date with respect to the Regeneron Territory shall be allocated between the
Parties pursuant to the Praluent Transition Services Agreement. Sanofi shall be
solely responsible for any Sales Deduction Costs (including, for clarity, with
respect to any pre-Transition Date sales) incurred by Sanofi or any of its
Affiliates after the Transition Date with respect to the Sanofi Territory;
provided that Sanofi shall have the sole benefit of the provisions or reserves
established by Sanofi with respect thereto under the LCA.
8.7 Reimbursement. For all amounts for which a Party (the “Owing Party”) is
obligated to reimburse or pay the other Party or its designated Affiliate (the
“Owed Party”) pursuant to this Agreement for which no specific provision is made
hereunder for such payment, the Owed Party shall send to the Owing Party an
invoice for such amount within [* * *] days after the Owed Party’s determination
that such amount is payable by the Owing Party, which invoice shall include a
reference to the section of this Agreement under which the Owed Party is
requesting reimbursement or payment and be accompanied by reasonable
documentation of the incurrence or accrual of the costs to be reimbursed.
Payment with respect to each such invoice shall be due within [* * *] days after
receipt by the Owing Party thereof and shall be made in accordance with Section
8.8; provided, however, that if the Owing Party in good faith disputes any
portion of any such invoice, it shall pay the undisputed portion and shall
provide the Owed Party with written notice of the disputed portion and its
reasons therefor, and the Owing Party shall not be obligated to pay such
disputed portion unless and until such dispute is
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resolved in favor of the Owed Party. The Parties shall use good faith efforts to
resolve any such disputes promptly.
8.8 Payment Method and Currency. Payments under this Agreement shall be made by
bank wire transfer in immediately available funds to a bank account designated
by the Party to which such payments are due. All sums due under this Agreement
shall be payable in United States Dollars. In those cases where the amount due
in United States Dollars is calculated based upon one or more currencies other
than United States Dollars, such amounts shall be converted to United States
Dollars (a) in respect of any payment by Regeneron, using the average of the
daily buying and selling exchange rates for conversion of the applicable foreign
currency into Dollars, using the spot rates (the “Mid Price Close” found on
Bloomberg, or any other source as agreed to by the Parties) for each day of the
period to which the payment relates, and (b) in respect of any payment by
Sanofi, using the average of the Reuters mid-market spot rate snapshots at 3.30
pm Paris time for each day of the period to which the payment relates.
8.9 Late Payments. Unless otherwise mutually agreed by the Parties or otherwise
provided in this Agreement, all payments under this Agreement shall earn
interest, to the extent permitted by applicable Law, from the date due until
paid at a rate equal to one (1) month London Inter-Bank Offering Rate (LIBOR)
Dollars, as quoted on Bloomberg (or any other source agreed to by the Parties)
effective for the date on which the payment was due, plus [* * *] percent ([* *
*]%) (such sum being referred to as the “Default Interest Rate”).
Notwithstanding the foregoing, if the London Inter-Bank Offering Rate ceases to
be available, the Default Interest Rate shall be the Secured Overnight Financing
Rate (SOFR), as quoted by the Federal Reserve Bank of New York (or a successor
administrator) on the Federal Reserve Bank of New York’s Website, plus [* * *]
percent ([* * *]%).
8.10 Taxes.
(a)Each Party shall be responsible for any taxes imposed on or measured by net
income or gross income (including branch profits), gross receipts, capital,
ability or right to do business, property and franchise or similar taxes
pursuant to applicable Law. Any withholding or other taxes that either Party or
its Affiliates are required by Law to withhold or pay on behalf of the other
Party, with respect to any payments to such other Party hereunder, shall be
deducted from such payments and timely paid to the appropriate tax authority;
provided, however, that the withholding Party shall promptly furnish to the
other Party proper evidence or other reasonable documentation of the taxes so
paid. Each Party shall cooperate with the other and furnish to the other Party
appropriate documents to secure application of the most favorable rate of
withholding tax under applicable Law (or exemption from such withholding tax
payments, as applicable). Without limiting the foregoing, each Party agrees to
make all lawful and reasonable efforts to minimize any such taxes, assessments
and fees and will claim on the other Party’s behalf the benefit of any available
treaty on the avoidance of double taxation that applies to any payments
hereunder to such other Party.
(b)To the extent applicable and reasonably requested by Regeneron, Sanofi shall
use commercially reasonable efforts to provide Regeneron with any documentation
or other certifications required pursuant to Section 250(b) of the Code and any
regulations or other guidance promulgated thereunder necessary for any payments
made to Regeneron pursuant to
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this Agreement to qualify as “foreign-derived deduction eligible income” within
the meaning of Section 250(b)(4) of the Code. Regeneron shall reimburse Sanofi
for all reasonable Out-of-Pocket Costs incurred by Sanofi in connection with
providing such documentation or other certification to Regeneron.
8.11 Sanofi Records; Audits by Regeneron. Sanofi shall, and shall cause its
Affiliates and its and their Sublicensees to, maintain complete and accurate
books and records in accordance with applicable Accounting Standards in
sufficient detail to permit Regeneron to confirm the actual number of FTEs
allocated to activities for which reimbursement is sought from Regeneron and the
accuracy of royalty payments and any other compensation or reimbursement payable
under this Agreement for a period of two (2) years from the creation of
individual records or any longer period required by applicable Law. Regeneron
shall have the right (at its own cost), upon no less than thirty (30) days
advance written notice and at such reasonable times and intervals and to such
reasonable extent as Regeneron shall request, not more than once during any
consecutive twelve (12) month period, to have such books and records of Sanofi
and its Affiliates and its and their Sublicensees for the preceding two (2)
years available for review at a single location in France by an independent “Big
Four” (or equivalent) accounting firm of its choosing under confidentiality and
non-use obligations no less stringent than those set forth in Article 13, for
the sole purpose of verifying the accuracy of all financial reports furnished,
and payments made, by Sanofi pursuant to this Agreement; provided that no period
may be subjected to audit by Regeneron 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. Any such auditor shall not disclose any confidential information of
Sanofi to Regeneron, except to the extent such disclosure is necessary to verify
the accuracy of such reports or payments. The results of any such audit shall be
delivered in writing to each Party and shall, absent manifest error, be final
and binding upon the Parties. Any amounts shown by such audit to be owed but
unpaid shall be paid within thirty (30) days from the auditor’s report, plus
interest at the Default Interest Rate from the original due date. Any amounts
shown to have been overpaid may be credited by Sanofi against future payments to
Regeneron hereunder. No payment to Regeneron shall be reduced by more than [* *
*] percent ([* * *]%) as a result of such credit, and Sanofi may carry forward
any unused credits to future Calendar Quarters. Regeneron shall bear the full
cost of such audit unless such audit reveals a payment or reporting error of
more than [* * *] percent ([* * *]%) or more during the applicable audit period,
in which case Sanofi shall bear the full cost of such audit.
8.12 Regeneron Records; Audits by Sanofi. Regeneron shall, and shall cause its
Affiliates and its and their Sublicensees to, maintain complete and accurate
books and records in accordance with applicable Accounting Standards in
sufficient detail to permit Sanofi to confirm the actual number of FTEs
allocated to activities for which reimbursement is sought from Sanofi and the
accuracy of Regeneron’s calculations of any reimbursement payments owed by
Sanofi hereunder, including pursuant to Section 7.4, or any other payments for
which Sanofi is responsible under this Agreement (including in connection with
Section 4.7), for a period of two (2) years from the creation of individual
records or any longer period required by applicable Law. Sanofi shall have the
right (at its own cost), upon no less than thirty (30) days advance written
notice and at such reasonable times and intervals and to such reasonable extent
as Sanofi shall request, not more than once during any consecutive twelve (12)
month period, to have such books and records of Regeneron and its Affiliates and
its and their Sublicensees for the preceding two (2) years available for review
at a single location in the United States by an independent
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“Big Four” (or equivalent) accounting firm of its choosing under confidentiality
and non-use obligations no less stringent than those set forth in Article 13,
for the sole purpose of verifying the accuracy of such calculations; provided
that no period may be subjected to audit by Sanofi 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. Any such auditor shall not disclose any confidential
information of Regeneron to Sanofi, except to the extent such disclosure is
necessary to verify the accuracy of such calculations. The results of any such
audit shall be delivered in writing to each Party and shall, absent manifest
error, be final and binding upon the Parties. Any amounts shown by such audit to
be owed by Sanofi but unpaid shall be paid within thirty (30) days from the
auditor’s report, plus interest at the Default Interest Rate from the original
due date. Any amounts shown to have been overpaid by Sanofi may be credited by
Sanofi against future payments to Regeneron hereunder. Sanofi shall bear the
full cost of such audit unless such audit reveals a calculation error of [* * *]
percent ([* * *]%) or more during the applicable audit period, in which case
Regeneron shall bear the full cost of such audit.
ARTICLE 9
TRADEMARKS, COPYRIGHTS, CORPORATE LOGOS AND DOMAIN NAMES
9.1 Ownership. As between the Parties, (a) Regeneron shall own and retain all
right, title and interest in and to (i) the Praluent Product Regeneron
Copyrights, (ii) the Praluent Product U.S. Trademark(s), including the goodwill
of the business in connection with which the Praluent Product U.S. Trademarks
are used and that is symbolized by the Praluent Product U.S. Trademarks and
(iii) the Praluent Product U.S. Domain Names and (b) Sanofi shall own and retain
all right, title and interest in and to (i) the Praluent Product Sanofi
Copyrights, (ii) the Praluent Product ROW Trademark(s), including the goodwill
of the business in connection with which the Praluent Product ROW Trademark(s)
are used and that is symbolized by the Praluent Product ROW Trademark(s) and
(iii) the Praluent Product ROW Domain Names.
9.2 Prosecution, Maintenance, Enforcement, and Defense of Trademarks. Regeneron
shall, at its sole cost and expense, have the sole right to register, prosecute,
maintain, enforce and defend the Praluent Product U.S. Trademark(s) in the
Regeneron Territory and the Praluent Product U.S. Domain Names. Sanofi shall, at
its sole cost and expense, have the sole right to register, prosecute, maintain,
enforce and defend the Praluent Product ROW Trademark(s) in the Sanofi Territory
and the Praluent Product ROW Domain Names. With respect to the Transferred
Product Trademarks or Transferred Product Domain Names, Sanofi shall provide to
Regeneron all reasonable assistance requested by Regeneron in connection with
any Third Party claim or suit asserted against any such Transferred Product
Trademarks or Transferred Product Domain Names, at Regeneron’s cost and expense,
including allowing Regeneron access to Sanofi’s personnel who may have
possession of relevant information.
9.3 Use of Trademarks and Domain Names.
(a)Except as otherwise expressly provided in this Agreement, each Party, its
Affiliates and its and their Sublicensees shall have no rights in or to the
other Party’s Praluent Product Trademarks or the goodwill pertaining thereto or
to the other Party’s Praluent Product Domain Names. Each Party agrees that at no
time will it or any of its Affiliates or its or their
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Sublicensees seek to register or register any Trademark in the other Party’s
Territory that is confusingly similar to, misleading or deceptive with respect
to the Praluent brand name or take any action or do any act that endangers,
damages, dilutes, destroys or similarly affects, in any material respect, the
other Party’s ownership rights in or to the Praluent brand name or the value of
the goodwill pertaining thereto or attack, dispute or contest the validity of or
ownership of such other Party in or to the Praluent brand name or any
registrations or pending registration thereof. Each Party agrees that upon
termination of the license granted to it under Section 2.1(d) or Section 2.2(d),
as applicable, it will discontinue forthwith all use of the Praluent Product
Trademarks of the other Party.
(b)Each Party shall, and shall cause its Affiliates and its and their
Sublicensees to, (i) conform to customary industry standards for the protection
of, and comply with applicable Law with respect to the use of, the other Party’s
Praluent Product Trademarks and (ii) adhere to and maintain the highest quality
standards of the other Party with respect to goods sold and services provided
under the other Party’s Praluent Product Trademarks in the applicable country of
such other Party’s Territory.
9.4 Use of Corporate Names and Logos.
(a)Subject to Section 2.1(e) or Section 2.2(e), as applicable, neither Party
shall use the other Party’s or the other Party’s Affiliates’ corporate names or
logos on any product labels, package inserts, packaging, trade packaging,
samples or Promotional Materials (including any website or social media content)
related to any Praluent Product (including in congress booths or Promotional
Materials used or distributed in connection with the applicable Praluent
Product); provided, however, that such Party shall be permitted to identify the
other Party (or its Affiliate) as the Manufacturer of Finished Product or
Formulated Drug Substance, as applicable, in any such materials to the extent
required under any applicable Law and for so long as the other Party or its
Affiliate is supplying Finished Product or Formulated Drug Substance, as
applicable, to such Party or its Affiliates under a Praluent Supply Agreement.
Neither Party shall, and shall not permit its Affiliates or its or their
Sublicensees or distributors to, with respect to its activities under this
Agreement, take any action or do any act that endangers, damages, destroys or
similarly affects, in any material respect, the other Party’s or the other
Party’s Affiliates’ corporate names or logos or the value of goodwill pertaining
thereto.
(b)Each Party shall, and shall cause its Affiliates and its and their
Sublicensees to, (i) conform to customary industry standards for the protection
of, and comply with applicable Law with respect to the use of, the other Party’s
corporate names and logos and (ii) adhere to and maintain the highest quality
standards of the other Party with respect to goods sold and services provided
under the other Party’s corporate names or logos in the applicable country of
such other Party’s Territory.
ARTICLE 10
INTELLECTUAL PROPERTY
10.1 Ownership of Intellectual Property.
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(a)Subject to Section 10.1(b)(ii), each Party shall exclusively own all right,
title and interest in and to any and all intellectual property (including
Know-How, Patents and Copyrights) discovered, invented, authored or otherwise
created under or in connection with this Agreement solely by or on behalf of
such Party, its Affiliates or its or their Sublicensees (other than the other
Party or its Affiliates) (“Sole Inventions”). Sole Inventions made solely by or
on behalf of Sanofi, its Affiliates or its or their Sublicensees (other than
Regeneron and its Affiliates) are referred to herein as “Sanofi Sole
Inventions.” Sole Inventions made solely by or on behalf of Regeneron, its
Affiliates or its or their Sublicensees (other than Sanofi and its Affiliates)
are referred to herein as “Regeneron Sole Inventions.” The Parties agree that
nothing in this Agreement, and no use by a Party of the other Party’s
intellectual property pursuant to this Agreement, shall vest in a Party any
right, title or interest in or to the other Party’s intellectual property, other
than the license rights expressly granted hereunder.
(b)The Parties shall each own an equal, undivided interest in any and all
intellectual property (including Know-How, Patents and Copyrights) discovered,
invented, authored or otherwise created under or in connection with (i) this
Agreement jointly by or on behalf of Sanofi, its Affiliates or its or their
Sublicensees, on the one hand, and Regeneron, its Affiliates or its or their
Sublicensees, on the other hand or (ii) any Existing Trials conducted by or on
behalf of a Party or its Affiliates or its or their Sublicensees, including the
Existing Trials Information (“Joint Inventions”). Each Party shall disclose to
the other Party in writing and shall cause its Affiliates, and its and their
Sublicensees to so disclose, the conception, discovery, invention or reduction
to practice of any Joint Invention.
(c)Notwithstanding the foregoing in Section 10.1(a) and Section 10.1(b), except
with respect to intellectual property described in clause (ii) of the definition
of Joint Inventions, (i) for purposes of determining whether a patentable
invention is a Sanofi Sole Invention, a Regeneron Sole Invention or a Joint
Invention, questions of inventorship shall be resolved in accordance with United
States patent Laws, (ii) for purposes of determining whether a copyrighted work
is a Sanofi Sole Invention, a Regeneron Sole Invention or a Joint Invention,
questions of Copyright authorship shall be resolved in accordance with United
States Copyright Laws, and (iii) for purposes of determining whether Know-How
(other than copyrighted work and patentable inventions) is a Sanofi Sole
Invention, a Regeneron Sole Invention or a Joint Invention, questions of
authorship or inventorship shall be resolved in accordance with the Laws of the
State of New York, United States.
(d)To the extent that any right, title or interest in or to any intellectual
property vests in a Party, by operation of law or otherwise, in a manner
contrary to the agreed upon ownership as set forth in this Agreement, such Party
shall, and hereby does, irrevocably assign, and shall cause its Affiliates and
its and their Sublicensees to so assign, to the other Party any and all such
right, title and interest in and to such intellectual property to the other
Party without the need for any further action by the other Party.
(e)Subject to Section 2.1, Section 2.2, Section 2.3 and Section 11.1, as
applicable, each Party’s interest in the Joint Intellectual Property may be
used, practiced, (sub)licensed and enforced, and any ownership rights therein
transferred, in whole or in part, by
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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 Intellectual
Property without securing the transferee’s written agreement to be bound by the
terms of this Section 10.1(e) and the other terms of this Agreement that relate
to the Joint Intellectual Property; provided, further, that nothing in this
Article 10 shall relieve a Party or its Affiliates of their obligations under
Article 13. Except as otherwise provided in this Agreement with respect to the
Praluent Royalty Products, neither Party 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, (sub)license, or other exploitation of such Party’s
interest in the Joint Intellectual Property.
10.2 Prosecution and Maintenance of Patents.
(a)Subject to Section 10.2(c), Regeneron shall control the preparation, filing,
prosecution and maintenance of the Regeneron Core Patents, the Sanofi Core
Patents and the Joint Patents, in each case, in the Regeneron Territory (the
“Regeneron Managed Patents”) [* * *], provided it shall confer with and keep
Sanofi reasonably informed regarding the status of such activities.
(b)Subject to Section 10.2(c), Sanofi shall control the preparation, filing,
prosecution and maintenance of the Regeneron Core Patents, the Sanofi Core
Patents and the Joint Patents, in each case, in the Sanofi Territory (the
“Sanofi Managed Patents”), [* * *], provided it shall confer with and keep
Regeneron reasonably informed regarding the status of such activities.
(c)Promptly following the Transition Date, the Parties shall [* * *].
(d)Unless otherwise agreed by the Parties, all Out-of-Pocket Costs incurred in
the filing, prosecution and maintenance of any Patents and any extensions
thereof shall be [* * *] borne by the Parties according to the cost allocation
provided in Section 10.2(a) and Section 10.2(b).
(e)Each Party agrees to cooperate with the other Party with respect to the
preparation, filing, prosecution and maintenance of the Regeneron Core Patents,
Sanofi Core Patents and Joint Patents pursuant to this Section 10.2, including
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 such preparation, filing, prosecution or
maintenance.
(f)Each Party shall reasonably cooperate with the other Party in order to make
such transfers of responsibilities, documents, and information as are needed in
order to effectuate the allocation of rights and responsibilities provided in
this Section 10.2.
10.3 Interference, Opposition and Reissue.
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(a)Each Party shall notify the other Party within ten (10) days of receipt by
such Party of information concerning the request for, or filing or declaration
of, any interference, opposition, post-grant review, reissue, reexamination, or
other similar proceedings relating to the Patents for which it controls filing,
prosecution and maintenance in accordance with Section 10.2. The Parties shall
thereafter consult and cooperate fully to determine a course of action with
respect to any such proceeding. Decisions on whether to initiate such a
proceeding and the course of action in such proceeding, including settlement
negotiations and terms and selection of counsel, will be made (i) with respect
to Regeneron Managed Patents, by Regeneron and (ii) with respect to Sanofi
Managed Patents, by Sanofi. For clarity, the provisions of this Section 10.3
(other than the first sentence of Section 10.3(a)) shall apply to any
interference, opposition, post-grant review, reissue, reexamination, or other
similar proceeding with respect to the Regeneron Core Patents, Sanofi Core
Patents or Joint Patents, in each case, that was initiated prior to the
Transition Date.
(b)Unless otherwise agreed by the Parties, all Out-of-Pocket Costs incurred in
connection with any such interference, opposition, post-grant review, reissue,
reexamination or other similar proceeding shall be shared as follows:
(i) If such proceeding relates to Regeneron Managed Patents – [* * *]; and
(ii) If such proceeding relates to Sanofi Managed Patents - [* * *].
(c)Each Party shall reasonably cooperate with the other Party in order to make
such transfers of responsibilities, documents, and information as are needed in
order to effectuate the allocation of rights and responsibilities provided in
this Section 10.3.
10.4 Background Patents. For the avoidance of doubt, as between the Parties, (a)
Regeneron has the sole right, but not the obligation, to prepare, file,
prosecute and maintain, and defend against interference, opposition, post-grant
review, reissue or reexamination proceedings in respect of, the Regeneron
Background Patents at its cost and expense and (b) Sanofi has the sole right,
but not the obligation, to prepare, file, prosecute and maintain, and defend
against interference, opposition, post-grant review, reissue or reexamination
proceedings in respect of, the Sanofi Background Patents at its cost and
expense.
ARTICLE 11
PATENT LITIGATION
11.1 Enforcement of Patents.
(a)In the event that either Party or any of its Affiliates becomes aware of an
actual or suspected infringement or unauthorized use, as applicable, of a Sanofi
Core Patent, a Regeneron Core Patent or a Joint Patent, in each case, by a Third
Party’s activities in the Territory (a “Patent Infringement”), the Party that
became aware of the Patent Infringement shall notify the other Party in writing
within five (5) Business Days and shall provide such other Party with all
available evidence supporting such Patent Infringement. As soon as reasonably
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practicable after the receipt of such notice, the Parties shall meet and
consider the appropriate course of action with respect to such Patent
Infringement.
(b)With respect to any Patent Infringement, (i) Regeneron shall have the first
right (and, with respect to the Regeneron Core Patents in the Regeneron
Territory, the sole right) to bring and control any action or proceeding
(including, subject to Section 11.1(c), any settlement) with respect to Patent
Infringement of any Regeneron Managed Patent at Regeneron’s costs and expenses,
and (ii) Sanofi shall have the first right (and, with respect to the Sanofi Core
Patents in the Sanofi Territory, the sole right) to bring and control any action
or proceeding (including, subject to Section 11.1(c), any settlement) with
respect to Patent Infringement of any Sanofi Managed Patent at Sanofi’s costs
and expenses (the Party with the first right or the sole right being referred to
as the “Lead Enforcement Party”); provided, however, that the Parties shall
ensure that there is proper communication and coordination of activities between
the Parties. If the Lead Enforcement Party has the first right (but not the sole
right) and fails to bring any such action or proceeding with respect to Patent
Infringement of the applicable Patent by a Third Party within sixty (60) days
following notice of the alleged Patent Infringement (or such other period of
time as may be required by applicable Law), the non-Lead Enforcement Party shall
have the right to bring and control any such action at its own cost and expense
by providing written notice to the other Party (the Party who controls the
litigation to be referred to as the “Enforcing Party”). The non-Enforcing Party
will provide reasonable assistance to the Enforcing Party in prosecuting any
action, and if required by applicable Law, will join in the action at the
Enforcing Party’s cost and expense. Although the Enforcing Party has the right
to select counsel of its own choice, it shall first consult with the other Party
and consider in good faith the recommendations of the other Party. The
non-Enforcing Party shall have the right to join in any litigation using counsel
of its choice at its sole discretion and cost and expense, subject to Section
11.1(c). The amount of any recovery from any such Patent Infringement action
shall be [* * *].
(c)If the Enforcing Party is the Lead Enforcement Party, then, subject to
Section 11.4(c), the Lead Enforcement Party has the right to settle any Patent
Infringement suit [* * *]. If the Enforcing Party is not the Lead Enforcement
Party, then the Enforcing Party [* * *].
(d)For the avoidance of doubt, as between the Parties, (i) Regeneron has the
sole right, but not the obligation, to bring and control at its cost and expense
any action or proceeding (including any settlement) with respect to any actual
or suspected infringement or unauthorized use of a Regeneron Background Patent
by a Third Party’s activities in the Territory and (ii) Sanofi has the sole
right, but not the obligation, to bring and control at its cost and expense any
action or proceeding (including any settlement) with respect to any actual or
suspected infringement or unauthorized use of a Sanofi Background Patent by a
Third Party’s activities in the Territory.
11.2 Patent Marking. Each Party shall comply with the patent marking statutes in
each country in which any Praluent Product is made, offered for sale, sold or
imported by or on behalf of such Party, its Affiliates or its or their
Sublicensees.
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11.3 Third Party Infringement Claims.
(a)If either Party or its Affiliates or its or their Sublicensees becomes aware
of a claim or assertion that the Manufacture, Development or Commercialization
of any Praluent Product infringes or otherwise violates the intellectual
property rights of any Third Party in such Party’s Territory, such Party shall
notify the other Party in writing of this claim or assertion within five (5)
Business Days. As soon as reasonably practicable after the receipt of such
notice, the Parties shall meet and consider the appropriate course of action
with respect to such allegation of infringement.
(b)Subject to Section 14.1(c), the Parties shall cooperate, share all material
notices and filings in a timely manner, provide all reasonable assistance to
each other and use commercially reasonable efforts to mutually agree upon an
appropriate course of action, including, as appropriate, with respect to
material court filings and the defense or settlement of any such claim or
assertion; provided, however, that a Party (the “Controlling Party”) shall have
the first right to defend and control the defense of any claimed infringement
action commenced by a Third Party naming it as a defendant alleging that the
Manufacture, Development or Commercialization of any Praluent Product infringes
or otherwise violates the intellectual property rights of such Third Party in
the Controlling Party’s Territory at its sole cost and expense, using counsel of
its own choice even if the other Party is also named as a defendant, to the
extent that such claimed infringement or violation solely relates to the
Manufacture, Development or Commercialization of the Praluent Products in the
Controlling Party’s Territory and does not relate to the other Party’s Territory
or to the manufacture, development or commercialization of other products;
provided further that, if the Controlling Party fails to initiate and maintain
the defense of any such action that names the other Party as a defendant, then
such other Party shall have the right to control the defense of such action at
its own cost and expense by providing written notice to the Controlling Party.
(c)Subject to Section 14.1(c), unless otherwise agreed by the Parties, each
Party shall bear [* * *] Out-of-Pocket Costs and internal costs (except for the
costs and expenses of the non-Controlling Party’s cooperation pursuant to
Section 11.3(b), if only one Party defends a claim) incurred in connection with
any litigation under this Section 11.3.
(d)For the avoidance of doubt, subject to Section 14.1(c), neither Party will
enter into any settlement of any suit involving any Praluent Product that [* *
*].
11.4 Invalidity or Unenforceability Defenses or Actions.
(a)In the event that a Third Party asserts, as a defense or as a counterclaim in
any Patent Infringement action under Section 11.1 or in a declaratory judgment
action or similar action or claim filed by such Third Party, that any Regeneron
Core Patent, Sanofi Core Patent or Joint Patent is invalid or unenforceable (a
“Third Party Invalidity Assertion”), then the Party first becoming aware of such
Third Party Invalidity Assertion shall give written notice thereof to the other
Party within five (5) Business Days.
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(b)With respect to any Third Party Invalidity Assertion, (i) Regeneron shall, at
its cost and expense, have the first right (and, with respect to the Regeneron
Core Patents in the Regeneron Territory, the sole right) to control the defense
of such Third Party Invalidity Assertion (including, subject to Section 11.4(c),
any settlement thereof) to the extent that it relates to any Regeneron Managed
Patent and (ii) Sanofi shall, at its cost and expense, have the first right
(and, with respect to the Sanofi Core Patents in the Sanofi Territory, the sole
right) to control the defense of such Third Party Invalidity Assertion
(including, subject to Section 11.4(c), any settlement thereof) to the extent
that it relates to any Sanofi Managed Patent (the Party with the first right or
the sole right being referred to as the “Lead Defense Party”); provided,
however, that the Parties shall ensure that there is proper communication and
coordination of activities between the Parties. If the Lead Defense Party has
the first right (but not the sole right) and fails to initiate and maintain the
defense of a Third Party Invalidity Assertion, the non-Lead Defense Party shall
have the right to control such defense at its own cost and expense by providing
written notice to the other Party (the Party who controls the defense to be
referred to as the “Defending Party”). The non-Defending Party will provide
reasonable assistance to the Defending Party in the defense of any applicable
Third Party Invalidity Assertion, and if required by applicable Law, will join
in the applicable action at the Defending Party’s cost and expense. Although the
Defending Party has the right to select counsel of its own choice, it shall
first consult with the other Party and consider in good faith the
recommendations of the other Party. The non-Defending Party shall have the right
to join in any applicable action using counsel of its choice at its sole
discretion and cost and expense, subject to Section 11.4(c).
(c)If the Defending Party is the Lead Defense Party, then the Lead Defense Party
has the right to settle any Third Party Invalidity Assertion action [* * *]. If
the Defending Party is not the Lead Defense Party, then the Defending Party [* *
*].
(d)For the avoidance of doubt, as between the Parties, (i) Regeneron has the
sole right, but not the obligation, to control the defense (including any
settlement thereof) of any assertion by a Third Party (whether as a defense or
as a counterclaim in any infringement action or in a declaratory judgment action
or similar action or claim filed by such Third Party) that any Regeneron
Background Patent is invalid or unenforceable and (ii) Sanofi has the sole
right, but not the obligation, to control the defense (including any settlement
thereof) of any assertion by a Third Party (whether as a defense or as a
counterclaim in any infringement action or in a declaratory judgment action or
similar action or claim filed by such Third Party) that any Sanofi Background
Patent is invalid or unenforceable.
11.5 Interference, Opposition and Reissue of Third Party Patents.
(a)With respect to each interference, opposition, post-grant review, reissue or
reexamination proceeding that is set forth on Schedule 11.5(a) (the “Existing
Sole Oppositions”), the Party designated as the “Acting Party” on Schedule
11.5(a) for such Existing Sole Opposition (the “Acting Party”) shall consult and
cooperate fully with the other Party (the “Directing Party”) to determine a
course of action with respect to any such proceeding [* * *]. Unless otherwise
agreed by the Parties, Out-of-Pocket Costs incurred by the Acting Party after
the Transition Date in connection with any Existing Sole Opposition shall be
borne [* * *].
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(b)With respect to each interference, opposition, post-grant review, reissue or
reexamination proceeding that is set forth on Schedule 11.5(b) (each, an
“Existing European Opposition”), the Party designated as the “Opposing Party” on
Schedule 11.5(b) (the “Opposing Party”) shall have the sole right and
responsibility, [* * *], to carry out such course of action as the Opposing
Party may determine in its sole discretion in respect of such Existing European
Opposition, including settlement negotiations and terms.
(c)If either Party or one of its Affiliates or its or their Sublicensees desires
to initiate any interference, opposition, post-grant review, reissue or
reexamination proceeding relating to a Patent of a Third Party in furtherance of
Developing, Manufacturing or Commercializing a Praluent Product in the Territory
on or after the Transition Date, then such Party shall notify the other Party in
writing of such desire. As soon as reasonably practicable after the receipt of
such notice, the Parties shall meet and consider the appropriate course of
action with respect to such proposed interference, opposition, post-grant
review, reissue or reexamination proceeding.
(d)Except as otherwise provided in this Section 11.5, each Party is responsible
for any and all activities in respect of any interference, opposition,
post-grant review, reissue or reexamination proceedings relating to a Patent of
a Third Party in furtherance of Developing, Manufacturing or Commercializing a
Praluent Product in such Party’s Territory.
11.6 Transfer of Responsibilities. Each Party shall reasonably cooperate with
the other Party in order to make such transfers of responsibilities, documents,
and information as are needed in order to effectuate the allocation of rights
and responsibilities provided in this Article 11
ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1 Due Organization, Valid Existence and Due Authorization. Each Party
represents and warrants to the other Party, as of each of the Execution Date and
the Transition 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 encumbrances nor any other material agreement
or arrangement, whether written or oral, by which it is bound nor any
requirement of applicable Laws; (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 and other rights granted to the other Party hereunder; and
(f) no broker, finder or investment banker is entitled to any brokerage,
finder’s or other fee in connection with this Agreement or the transactions
contemplated hereby based on arrangements made by it or on its behalf.
12.2 Additional Representations and Warranties of the Parties.
(a)Regeneron Representations and Warranties. Regeneron represents that, as of
each of the Execution Date and the Transition Date, Regeneron (i) owns or
Controls all of the
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Patents listed on Schedule 1.135 and has the right to grant the licenses or
sublicenses, as the case may be, granted under such Patents under this Agreement
and (ii) Regeneron does not own or Control any Regeneron Core Patents existing
as of the Transition Date, other than the Patents listed on Schedule 1.135.
(b)Sanofi Representations and Warranties.
(i) Sanofi represents that, as of each of the Execution Date and the Transition
Date:
(A)Sanofi owns or Controls all of the Patents listed on Schedule 1.156 and has
the right to grant the licenses or sublicenses, as the case may be, granted
under such Patents under this Agreement.
(B)Sanofi does not own or Control any Sanofi Core Patents existing as of the
Transition Date, other than the Patents listed on Schedule 1.156.
(C)Sanofi has, or its Affiliates have, good title to the entire legal ownership
interest of or in, or valid contract rights in or right to transfer, as
applicable, the Transferred U.S. Assets.
(D)The Transferred Approvals are in full force and effect.
(ii) Sanofi represents that, as of the Execution Date:
(A)No opposition, cancellation or court proceeding is pending, or to Sanofi’s
knowledge, threatened in writing; no opposition, cancellation or court
proceeding regarding the Transferred Product Trademarks has been settled; and
Sanofi has not entered into any co-existence agreements, prior rights
agreements, covenants not to sue or settlement or other similar agreements
regarding the Transferred Product Trademarks.
(B)No written notice of default or termination has been received or given by
Sanofi or any of its Affiliates under any U.S.-Related Praluent Agreement.
(C)No proceeding is pending or, to Sanofi’s knowledge, threatened in writing
regarding the revocation or termination of any Transferred Approval.
(D)Neither Sanofi nor any of its Affiliate(s) have given or received written
notice to or from any Person relating to any alleged breach or default under any
Transferred Product Contracts.
(E)Each of the Transferred Product Contracts represents a legal, valid and
binding obligation of Sanofi or the Sanofi Affiliate(s) that are party thereto
and is enforceable against Sanofi or such Affiliate(s), in accordance with its
terms, and is in full force and effect, subject to (A) the effects of
bankruptcy, insolvency, fraudulent conveyance, reorganization, moratorium and
other similar Laws relating to or affecting the enforcement of
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creditors’ rights generally and (B) general equitable principles (whether
considered in a proceeding in equity or at Law).
(c)Knowledge of Pending or Threatened Litigation or Adverse Agreements. Except
as set forth on Schedule 12.2(c), each Party represents and warrants to the
other Party that, as of the Transition Date, there is (i) no claim, announced
investigation, suit, action or proceeding pending or, to such Party’s knowledge,
threatened, against such Party or any of its Affiliates before or by any
governmental entity or arbitrator and (ii) to such Party’s knowledge, no
agreement entered into by such Party or its Affiliates that, in each case ((i)
and (ii)), individually or in the aggregate, could reasonably be expected to (A)
materially impair the ability of such Party to perform any of its obligations
under this Agreement, (B) prevent or materially delay or alter the consummation
of any or all of the transactions contemplated hereby or (C) have a materially
adverse effect on (1) if such other Party is Regeneron, the U.S. Praluent
Product Business or (2) if such other Party is Sanofi, the ROW Praluent Product
Business.
12.3 Disclaimer of Warranties. EXCEPT AS OTHERWISE SPECIFICALLY PROVIDED IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS,
IMPLIED, STATUTORY OR OTHERWISE, CONCERNING THE SUCCESS OR POTENTIAL SUCCESS OF
THE DEVELOPMENT, COMMERCIALIZATION, MARKETING OR SALE OF ANY PRALUENT PRODUCT.
EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
12.4 Mutual Covenants. Each Party hereby covenants to the other Party as of the
Transition Date as follows: (a) it will not grant any right or license to any
Third Party in the Territory that would be inconsistent with or in conflict with
or in derogation of the rights granted to the other Party under this Agreement,
and will not take any action that would reasonably be expected to materially
conflict with, or have a materially adverse effect on, its obligations to the
other Party under this Agreement and (b) in the course of the conduct of any
Existing Trial, it will not knowingly use and will not have knowingly used an
employee or consultant who is or has been debarred by a Regulatory Authority or,
to the best of such Party’s knowledge, is or has been the subject of debarment
proceedings by a Regulatory Authority.
ARTICLE 13
CONFIDENTIALITY
13.1 Confidential Information. Each of Sanofi and Regeneron acknowledges that
all Party Information provided to it (or its Affiliate) or otherwise made
available to it by the other Party or its respective Affiliates pursuant to this
Agreement or the LCA, as applicable, is confidential and proprietary to such
other Party or its respective Affiliates. Furthermore, each of Sanofi and
Regeneron acknowledges (subject to the further provisions of this Article 13)
that all Joint Information is confidential and proprietary to both Parties (and
both Parties shall be deemed to be the receiving Party with respect thereto).
Subject to the further provisions of this Article 13, each of Sanofi and
Regeneron agrees to, (a) maintain the Party Information of the other Party and
all Joint Information in confidence until ten (10) years after such other Party
and its Affiliates and its and their Sublicensees have
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permanently ceased Development and Commercialization of all Praluent Products,
provided that (i) Sanofi shall maintain in confidence any Regeneron
Manufacturing Know-How that Regeneron maintains as a trade secret for so long as
Regeneron continues to maintain the same as a trade secret and (ii) Regeneron
shall maintain in confidence any Sanofi Manufacturing Know-How that Sanofi
maintains as a trade secret for so long as Sanofi continues to maintain the same
as a trade secret and (b) use such Party Information and Joint Information
solely for the purpose of exercising its rights and performing its obligations
under this Agreement, provided that nothing herein will prohibit either Party
from using any Know-How included in clause (a) of the definition of Existing
Joint Know-How or clause (a) of the definition of Party Information, in either
case, solely to the extent necessary or useful for the development or
commercialization of such Licensed Products (as defined in the LCA) pursuant to
the LCA, as if such Know-How were Party Information or New Information (each as
defined in the LCA), as applicable, under the LCA, only to the extent such use
is necessary or useful for such development or commercialization of such
Licensed Products. Each of Sanofi and Regeneron covenants that neither it nor
any of its respective Affiliates shall disclose any Party Information of the
other Party or Joint Information to any Third Party except (i) to its employees,
agents, consultants or any other Person under its authorization (e.g.,
collaborators, (sub)licensees or vendors); provided such employees, agents,
consultants or Persons are subject in writing to substantially the same
confidentiality obligations as the Parties, (ii) as approved by both Parties
hereunder or (iii) as set forth elsewhere in this Agreement. Without limiting
the foregoing, Sanofi shall limit access to Regeneron Manufacturing Know-How to
only those of Sanofi’s employees, agents, consultants or other Persons under its
authorization that have a need for such access in order to enable Sanofi to
exercise its rights or perform its obligations under this Agreement or any
Ancillary Services Agreement.
13.2 Exclusions. Notwithstanding anything provided above, the confidentiality
and non-use restrictions provided in this Article 13 shall not apply to Party
Information or Joint Information that was or is (and such information shall not
be considered confidential or proprietary under this Agreement):
(a)already in the public domain as of the Transition Date or becomes publicly
known through no act, omission or fault of the receiving Party or any of its
Affiliates or any Person to whom the receiving Party or its Affiliate provided
such information;
(b)already in the possession of the receiving Party or any of its Affiliates,
other than under an obligation of confidentiality, at the time of disclosure by
the disclosing Party; provided, however, that this exception shall not apply
with respect to Joint Information;
(c)disclosed to the receiving Party or any of its Affiliates on an unrestricted
basis from a Third Party not under an obligation of confidentiality to the other
Party or any of its Affiliates with respect to such information; or
(d)similar in nature to the Party Information of the other Party or Joint
Information but has been independently created outside of this Agreement, as
evidenced by written or electronic documentation, without any aid, application
or use of such Party Information or Joint Information.
13.3 Permitted Disclosures and Uses.
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(a)Each Party may use or disclose Party Information of the other Party and Joint
Information to the extent that such use or disclosure is:
(i) necessary to file, prosecute, enforce or defend Patents for which the
disclosing Party has the right to assume filing, prosecution, enforcement,
defense or maintenance pursuant to this Agreement; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information to the extent practicable and consistent with applicable Law;
(ii) subject to Section 13.3(c), required by a Governmental Authority,
applicable Law (including the rules and regulations of any stock exchange or
trading market on which the receiving Party’s (or its parent entity’s)
securities are traded) or court order to be disclosed, provided that the
receiving Party uses reasonable efforts to give the disclosing Party advance
notice of such required disclosure in sufficient time to enable the disclosing
Party to seek confidential treatment for such information or to request that the
receiving Party seek confidential treatment for such information, and provided
further that the receiving Party provides all reasonable cooperation to assist
the disclosing Party to protect such information and limits the disclosure to
that information that is required by a Governmental Authority, applicable Law
(including the rules and regulations of any stock exchange or trading market on
which the receiving Party’s (or its parent entity’s) securities are traded) or
court order to be disclosed;
(iii) to enforce the terms of this Agreement or any Ancillary Agreement if the
disclosing Party gives reasonable advance notice to the other Party to permit
the other Party a sufficient opportunity to take any measures to ensure
confidential treatment of such information and the disclosing Party shall
provide reasonable cooperation to protect the confidentiality of such
information; or
(iv) to the Regulatory Authorities as required in connection with such Party’s
regulatory interactions with respect to such Party’s Manufacturing, Development
or Commercialization activities conducted in accordance with the terms and
conditions of this Agreement (including the licenses and other rights granted to
such Party); provided, however, that reasonable measures shall be taken to
assure confidential treatment of such information to the extent practicable and
consistent with applicable Law.
(b)Notwithstanding anything else in this Agreement to the contrary, each Party
(and each employee, representative, or other agent of such 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 either Party (or to any
employee, representative, or other agent of either Party) relating to such tax
treatment or tax structure, provided, however, that this authorization of
disclosure shall not apply to disclosures reasonably necessary to comply with
applicable securities Laws, which disclosures shall be governed by Section
13.3(a)(ii).
(c)Notwithstanding anything else in this Agreement to the contrary, if either
Party or any of its Affiliates receives a request for any Regeneron
Manufacturing Know-How, if
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such Party is Sanofi, or Sanofi Manufacturing Know-How, if such Party is
Regeneron, from any Governmental Authority under any freedom of information Law,
including the United States Freedom of Information Act or the State Council
Regulations on Open Government Information, then such Party shall (i) notify the
other Party of such request within one (1) Business Day, (ii) permit such other
Party or any of its Affiliates to oppose such request or to seek other
limitations on such request, in each case, to the extent consistent with the
applicable Law and (iii) provide such other Party with reasonable assistance in
opposing such request or seeking such limitations. Each Party shall not, and
shall cause its Affiliates not to, disclose any Regeneron Manufacturing
Know-How, if such Party is Sanofi, or Sanofi Manufacturing Know-How, if such
Party is Regeneron, to any Governmental Authority in response to a request under
any freedom of information Law without the other Party’s prior written consent,
not to be unreasonably withheld, conditioned or delayed; provided that such
other Party acknowledges and agrees that it would be unreasonable for it to not
consent to any disclosure if such lack of disclosure would cause such Party or
any of its Affiliates to violate applicable Law.
13.4 Injunctive Relief. The Parties hereby acknowledge and agree that the rights
of the Parties under this Article 13 are special, unique and of extraordinary
character, and that if either Party refuses or otherwise fails to act, or to
cause its Affiliates to act, in accordance with the provisions of this Article
13, such refusal or failure would result in irreparable injury to the other
Party, the exact amount of which would be difficult to ascertain or estimate and
the remedies at law for which would not be reasonable or adequate compensation.
Accordingly, if either Party refuses or otherwise fails to act, or to cause its
Affiliates to act, in accordance with the provisions of this Article 13, then,
in addition to any other remedy that may be available to any damaged Party at
law or in equity, such damaged Party will be entitled to seek specific
performance and injunctive relief, without posting bond or other security, and
without the necessity of proving actual or threatened damages or inadequacy of
monetary damages, which remedy such damaged Party will be entitled to seek in
any court of competent jurisdiction.
13.5 Publication. If either Sanofi or Regeneron (the “Publishing Party”) desires
to disclose any clinical trial results in respect of any Existing Trials in
scientific journals, publications or scientific presentations or otherwise, the
Publishing Party shall, unless the other Party and its Affiliates and its and
their Sublicensees have permanently ceased Development and Commercialization of
all Praluent Products, provide the other Party an advance copy of any proposed
publication or summary of a proposed oral presentation relating to such
Development results no later than ten (10) Business Days prior to submission for
publication or disclosure. Such other Party shall have a reasonable opportunity
to review and comment on such disclosure or publication and the Publishing Party
shall (a) remove any Party Information of the other Party or Joint Information
(other than such clinical trial results) that such other Party requests be
removed, (b) consider any other comments from the other Party in good faith and
(c) if requested by the other Party, shall delay or prevent such disclosure or
publication as reasonably proposed by such other Party. In the event 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. For clarity, neither Party
may disclose the Party Information of the other Party or the Joint Information
(other than such clinical trial results) in scientific journals, publications or
scientific presentations or other similar disclosures without such other Party’s
prior written consent, such consent not to be unreasonably withheld, conditioned
or delayed.
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13.6 Other Publications. In the event that Sanofi or Regeneron desires to issue
any press releases or public announcements concerning this Agreement or any
Ancillary Agreement or any other activities contemplated hereunder or
thereunder, including restructuring of the LCA in connection with this
Agreement, in each case, to the extent not otherwise addressed in Section 13.5,
except as prohibited by a Governmental Authority or applicable Law (including
the rules and regulations of any stock exchange or trading market on which the
issuing Party’s (or its parent entity’s) securities are traded), such Party
agrees, unless the other Party and its Affiliates and its and their Sublicensees
have permanently ceased Development and Commercialization of all Praluent
Products, to provide to the other Party a copy of any such public announcement,
as soon as reasonably practicable (which, except under extraordinary
circumstances, shall be at least five (5) Business Days) prior to its scheduled
release; provided, however, that, without prior submission to the other Party,
either Party may issue press releases or public announcements that incorporate
information concerning this Agreement or any Ancillary Agreement or any
activities contemplated hereunder or thereunder that was included in a press
release or public announcement that was previously approved by the other Party
as part of a press release or other public disclosure concerning this Agreement
or that contains only non-material factual (non-financial) information regarding
this Agreement (e.g., that this Agreement remains in effect). Except as
otherwise required by applicable Law, the Party whose press release has been
reviewed shall remove any Party Information of the reviewing Party that the
reviewing Party requests be removed. Except as required by applicable Law
(including the rules and regulations of any stock exchange or trading market on
which the issuing Party’s (or its parent entity’s) securities are traded), or in
connection with the enforcement of this Agreement, neither Party (or its
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 Agreement, without the prior written consent of the
other Party, which consent shall not be unreasonably withheld, conditioned 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 with a term of at least five (5) years. Each Party acknowledges that the
other Party, as a publicly traded company, is legally obligated to make timely
disclosures of all material events relating to its business. The Parties
acknowledge that either or both Parties may be obligated to file a copy of this
Agreement with the United States Securities and Exchange Commission or its
equivalent in the Territory. Each Party will be entitled to make such filing but
shall cooperate with each other and use reasonable efforts to obtain
confidential treatment of confidential information, including trade secrets, in
accordance with applicable Law. The filing Party will provide the non-filing
Party with an advance copy of this Agreement marked to show provisions for which
the filing Party intends to seek confidential treatment and will reasonably
consider the non-filing Party’s timely comments thereon.
ARTICLE 14
INDEMNITY
14.1 Indemnity and Insurance.
(a)Sanofi will defend, indemnify and hold harmless Regeneron, its Affiliates and
its and their respective officers, directors, employees, (sub)licensees,
distributors and agents (“Regeneron Indemnitees”) from and against all claims,
demands, liabilities, damages, penalties, fines, costs and expenses, including
reasonable attorneys’ and experts’ fees and costs and costs or amounts paid to
settle (collectively, “Damages”), arising from or occurring as a result of a
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Third Party’s claim, action, suit, judgment or settlement (a “Third Party
Claim”) against a Regeneron Indemnitee that is due to or based upon:
(i) the gross negligence, recklessness, bad faith, intentional wrongful acts or
omissions or violations of Law by Sanofi or its Affiliates (or its or their
respective agents, contractors, Sublicensees, distributors, representatives or
other Persons or entities working on their behalf) in connection with their
Development, Commercialization, or Manufacture of any Praluent Product from and
after the Transition Date, excluding any actions or omissions by or on behalf of
Sanofi for Regeneron in connection with any Ancillary Services Agreement;
(ii) the material breach by Sanofi, any of its Affiliates or its or their
Sublicensees of its obligations, covenants or representations and warranties
under this Agreement (other than any breach of an obligation, covenant,
representation or warranty under any Ancillary Services Agreement);
(iii) the exploitation of any Praluent Product by Sanofi and its Affiliates (or
its or their respective agents, contractors (including by or on behalf of
Regeneron for Sanofi in connection with any Ancillary Services Agreement),
Sublicensees, distributors, representatives or other Persons or entities working
on their behalf) from and after the Transition Date and any actions or omissions
in connection therewith, excluding any Special Claim or any actions or omissions
by or on behalf of Sanofi for Regeneron in connection with any Ancillary
Services Agreement; or
(iv) any U.S.-Related Praluent Agreement, except to the extent that the
applicable Third Party Claim is due to or based upon any change in the terms of
such U.S.-Related Praluent Agreement implemented by Sanofi or any of its
Affiliates at Regeneron’s direction under the Praluent Transition Services
Agreement; provided, however, that Regeneron shall be liable for payments or
reimbursement of rebates, fees, chargebacks and other payments to be made
pursuant to such U.S.-Related Praluent Agreements in respect of sales of
Praluent Products made after the Transition Date subject to and in accordance
with the Praluent Transition Services Agreement;
except, in each case ((i), (ii), (iii) and (iv)), to the extent that Damages
arise out of (A) the gross negligence, recklessness, bad faith, intentional
wrongful acts or omissions or violations of Law committed by Regeneron or its
Affiliates (or its or their respective agents, contractors, Sublicensees,
distributors, representatives or other Persons or entities working on their
behalf in connection with this Agreement) or (B) the material breach by
Regeneron or its Affiliates or its or their Sublicensees of its obligations,
covenants or representations and warranties under this Agreement, the Praluent
Transition Services Agreement, the Praluent Pharmacovigilance Transition
Services Agreement or any Praluent Services Agreement.
For clarity, Sanofi’s liability, other than with respect to Special Claims, for
any Damages arising from or occurring as a result of a Third Party Claim against
a Regeneron Indemnitee that is due to or based upon (x) any actions or omissions
by or on behalf of Sanofi for Regeneron in connection with any Ancillary
Services Agreement or (y) any breach by Sanofi, any of its Affiliates or its or
their Sublicensees of its obligations, covenants or representations and
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warranties under any Ancillary Services Agreement, in each case ((x) and (y)),
shall be governed by the applicable Ancillary Services Agreement.
(b)Regeneron will defend, indemnify and hold harmless Sanofi, its Affiliates and
its and their respective officers, directors, employees, Sublicensees,
distributors and agents (“Sanofi Indemnitees”) from and against all Damages
arising from a Third Party Claim against a Sanofi Indemnitee that is due to or
based upon:
(i) the gross negligence, recklessness, bad faith, intentional wrongful acts or
omissions or violations of Law by Regeneron or its Affiliates (or its or their
respective agents, contractors, Sublicensees, distributors, representatives or
other Persons or entities working on their behalf), in connection with their
Development, Commercialization, or Manufacture of any Praluent Product from and
after the Transition Date, excluding any actions or omissions by or on behalf of
Regeneron for Sanofi in connection with any Ancillary Services Agreement;
(ii) the material breach by Regeneron, any of its Affiliates or its or their
Sublicensees, of its obligations, covenants or representations and warranties
under this Agreement (other than any breach of an obligation, covenant,
representation or warranty under any Ancillary Services Agreement); or
(iii) the exploitation of any Praluent Product by Regeneron and its Affiliates
(or its or their respective agents, contractors (including by or on behalf of
Sanofi for Regeneron in connection with any Ancillary Services Agreement),
Sublicensees, distributors, representatives or other Persons or entities working
on their behalf) from and after the Transition Date and any actions or omissions
in connection therewith, excluding any Special Claim or any actions or omissions
by or on behalf of Regeneron for Sanofi in connection with any Ancillary
Services Agreement;
except, in each case ((i), (ii) and (iii)), to the extent that Damages arise out
of (A) the gross negligence, recklessness, bad faith, intentional wrongful acts
or omissions or violations of Law committed by Sanofi or its Affiliates (or its
or their respective agents, contractors, Sublicensees, distributors,
representatives or other Persons or entities working on their behalf in
connection with this Agreement) or (B) the material breach by Sanofi or its
Affiliates or its or their Sublicensees of its obligations, covenants or
representations and warranties under this Agreement, the Praluent Transition
Services Agreement, Praluent Pharmacovigilance Transition Services Agreement or
any Praluent Services Agreement.
For clarity, Regeneron’s liability, other than with respect to [* * *], for any
Damages arising from or occurring as a result of a Third Party Claim against a
Sanofi Indemnitee that is due to or based upon (x) any actions or omissions by
or on behalf of Regeneron for Sanofi in connection with any Ancillary Services
Agreement or (y) any breach by Regeneron, any of its Affiliates or its or their
Sublicensees of its obligations, covenants or representations and warranties
under any Ancillary Services Agreement, in each case ((x) and (y)), shall be
governed by the applicable Ancillary Services Agreement.
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(c)In the event of any (i) Third Party Claim alleging that [* * *] (any such
Third Party Claim described in this Section 14.1(c) and subject to the
exclusions set forth in this Section 14.1(c), a “Special Claim”), then:
(i) if any such Special Claim is due to or based upon Triggering Events that
occur prior to the Transition Date (including Special Claims that are due to or
based upon Triggering Event(s) that occur both prior to, and after, the
Transition Date), then (subject to Section 14.1(c)(iii)):
(A)the provisions of Section 14.2 shall not apply with respect to the defense of
such Special Claim and (1) the Parties shall cooperate in good faith to
establish a mutually agreeable strategy with respect to defending such Special
Claim, provided that, subject to Section 11.3, [* * *];
(B)with respect to any Damages (other than Litigation Costs) from such Special
Claim allocable to Triggering Events occurring prior to the Transition Date, the
Parties shall share such Damages on a [* * *] basis; and
(C)with respect to any Damages (other than Litigation Costs) from such Special
Claim allocable to Triggering Events occurring on or after the Transition Date,
[* * *];
(ii) if any such Special Claim is solely due to or based upon Triggering Events
occurring on or after the Transition Date (and is not due to or based upon
Triggering Events prior to the Transition Date, which shall be governed by
Section 14.1(c)(i)), then (subject to Section 14.1(c)(iii)):
(A)the provisions of Section 14.2 shall apply with respect to the defense of
such Third Party Claim; and
(B)with respect to any Damages (other than any costs or expenses allocated
pursuant to Section 14.2) from such Special Claim, (1) Regeneron shall
indemnify, defend and hold harmless the Sanofi Indemnitees, to the extent such
Damages are allocable to the Commercialization of any Praluent Product in the
Regeneron Territory, or the Development (other than the conduct of any Global
Clinical Trials) or Manufacturing (including by Sanofi or any of its Affiliates
for Regeneron under the Finished Product Supply Agreement) of any Praluent
Product in the Territory in support of Commercialization of such Praluent
Product in the Regeneron Territory and (2) Sanofi shall indemnify, defend and
hold harmless the Regeneron Indemnitees, to the extent such Damages are
allocable to the Commercialization of any Praluent Product in the Sanofi
Territory, or the Development (other than the conduct of any Global Clinical
Trials) or Manufacturing (including by Regeneron or any of its Affiliates for
Sanofi under the Praluent Substance Supply Agreement) of any Praluent Product in
the Territory in support of Commercialization of such Praluent Product in the
Sanofi Territory; and
(iii) if any Special Claim is allocable to the Global Clinical Trials, then:
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(A)the provisions of Section 14.2 shall not apply with respect to the defense of
such Special Claim and the Parties shall cooperate in good faith to establish a
mutually agreeable strategy with respect to defending such Special Claim and
shall share the Litigation Costs for such defense [* * *] that are Out-of-Pocket
Costs; provided that, subject to Section 11.3, Sanofi shall have final
decision-making authority with respect to any such Special Claims in the Sanofi
Territory and Regeneron shall have final decision-making authority with respect
to any such Special Claims in the Regeneron Territory; provided further that
neither Party shall settle any such Special Claim without the other Party’s
consent, not to be unreasonably withheld, conditioned or delayed; and
(B)the Parties shall share Damages (other than Litigation Costs) from such
Special Claim [* * *].
(d)For clarity, other than Special Claims (which are governed by Section
14.1(c)), all Damages that are due to or based upon any act or omission by or on
behalf of Regeneron or Sanofi prior to the Transition Date shall be governed by
the terms of the LCA as in effect immediately prior to the Transition Date.
(e)For clarity, for purposes of Section 14.1(a), Section 14.1(b), Section
14.1(c) and Section 14.1(d), any reference to Licensed Product (as defined in
the LCA) under any applicable section of the LCA shall be deemed to include a
reference to Praluent Product.
(f)Each Party shall maintain, at its own cost and expense, liability insurance
coverage on, or self-insurance of, its activities performed under this
Agreement. Such insurance will be maintained, at a minimum, until five (5) years
after such Party and its Affiliates and its and their Sublicensees have
permanently ceased Development and Commercialization of all Praluent Products,
with a reputable insurance carrier(s) or through self-insurance, and will
include Commercial General Liability and Products Liability insurance covering
damages arising from bodily injury (including death), property damage and
consequential loss, in an amount not less than [* * *] dollars ($[* * *]) per
occurrence and in the annual aggregate arising out of Third Party claims made
against the Parties in respect of the activities performed under this Agreement.
Maintenance of such insurance coverage will not relieve either Party of any
responsibility under this Agreement for damage in excess of insurance limits or
otherwise. Upon a Party’s written request, the other Party will promptly provide
it with a certificate from the insurer(s) or the insurer’s authorized
representative, or in the case of self-insurance, an authorized corporate
officer evidencing such insurance coverage.
14.2 Indemnity Procedure.
(a)The Party entitled to indemnification under this Article 14 (an “Indemnified
Party”) shall notify the Party potentially responsible for such indemnification
(the “Indemnifying Party”) within five (5) Business Days of being notified of
any claim or claims asserted or threatened against the Indemnified Party that
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 the Indemnifying Party. For the avoidance of
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doubt, the indemnification procedures in this Section 14.2 shall not apply to
Third Party Claims described in Section 14.1(c)(i), which shall be governed by
such section unless specified otherwise in such section.
(i) If the Indemnifying Party has acknowledged in writing to the Indemnified
Party the Indemnifying Party’s responsibility for defending a 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 (A) 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 (B) the Indemnified Party consents to such
compromise or settlement, which consent shall not be withheld, conditioned or
delayed unless such compromise or settlement involves (1) any admission of legal
wrongdoing by the Indemnified Party, (2) any payment by the Indemnified Party
that is not indemnified hereunder or (3) 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 cost and expense of the
Indemnifying Party, upon at least ten (10) Business Days’ prior written notice
to the Indemnifying Party of its intent to do so, to undertake the defense of
such claim for the account of the Indemnifying Party (with counsel reasonably
selected by the Indemnified Party and approved by the Indemnifying Party, such
approval not to be unreasonably withheld, conditioned 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, conditioned 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 14.2 and shall bear its own costs and expenses with respect to such
participation; provided, however, that the Indemnifying Party shall bear such
costs and expenses if counsel for the Indemnifying Party shall have reasonably
determined that such counsel may not properly represent both the Indemnifying
Party and the Indemnified Party.
(iii) Regardless of whether the Indemnifying Party assumes the defense of any
claim pursuant to this Section 14.2, the Indemnified Party shall and shall use
reasonable efforts to cause each indemnitee to, reasonably cooperate in the
defense or prosecution thereof and, if the Indemnifying Party assumes the
defense of any such claim, the Indemnified Party shall and shall use reasonable
efforts to cause each indemnitee to furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals, in each case, as may be reasonably
requested in connection therewith. Such cooperation shall include access upon
reasonable notice during
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normal business hours afforded to the Indemnifying Party to and reasonable
retention by the Indemnified Party of, records and information that are
reasonably relevant to such claim and making Indemnified Parties and other
employees and agents available on a mutually convenient basis to provide
additional information and explanation of any material provided hereunder, and
to the extent the Indemnified Party is entitled to indemnification pursuant to
this Article 14, the Indemnifying Party shall reimburse the Indemnified Party
for all its reasonable and verifiable Out-of-Pocket Costs in connection with
providing such assistance.
ARTICLE 15
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 embargoes, acts of terrorism, acts of war (whether war be declared or
not), insurrections, strikes, riots, civil commotions, epidemics, pandemics,
quarantines 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 16
TERM AND TERMINATION
16.1 Term. This Agreement is entered into as of the Execution Date but shall be
effective as of the Transition Date and shall, from and after the Transition
Date, remain in full force and effect in perpetuity and may not be terminated
other than pursuant to the terms and conditions of Section 16.2.
16.2 Termination of Licenses and Certain Contractual Restrictions. Each Party
(the “Terminating Party”) may terminate (a) the licenses and rights of reference
granted to the other Party (the “Breaching Party”) hereunder and (b) any
restrictions imposed upon the Terminating Party pursuant to Section 5.8
(provided however that the termination of such restrictions shall not be deemed
to expand the licenses and rights of reference granted by the Breaching Party to
the Terminating Party), in each case ((a) and (b)) upon prior written notice, if
the Breaching Party or any of its Affiliates or its or their Sublicensees
commits a material breach of its obligations under this Agreement. Any such
notice shall set forth in reasonable detail the facts underlying or constituting
the alleged breach (and specifically referencing the provisions alleged to have
been breached), and the termination of the applicable licenses, rights of
reference and contractual restrictions shall be effective ninety (90) days after
the date such notice is given unless the Breaching Party shall have cured such
breach within such ninety (90)-day period (or, if such material breach, by its
nature, is a curable breach but such breach is not curable within such ninety
(90)-day period, such longer period not to exceed one hundred eighty (180) days
so long as the Breaching Party is using commercially reasonable efforts to cure
such breach, in which event if such breach has not been cured, such termination
shall be effective on the earlier of the expiration of such one
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hundred eighty (180)-day period or such time as the Breaching Party ceases to
use commercially reasonable efforts to cure such breach).
16.3 Other Effects of Termination. From and after the effective date of any
termination pursuant to Section 16.2:
(a)If Regeneron is the Terminating Party, then Sanofi shall have no royalty
payment obligations hereunder with respect to Net Sales occurring after such
effective date.
(b)All of the Breaching Party’s rights and obligations hereunder specifically
relating to (i) if the Breaching Party is Regeneron, the U.S. Praluent Product
Business or (ii) if the Breaching Party is Sanofi, the ROW Praluent Product
Business, in each case ((i) and (ii)) shall immediately terminate (but not, for
clarity, any licenses and rights of reference granted by the Breaching Party
under Section 2.1, Section 2.2 or Section 6.2, as applicable). For clarity, all
of the Breaching Party’s rights and obligations under Article 13 and Article 14
shall continue in full force and effect, and all of the Breaching Party’s other
rights and obligations hereunder, including under any Ancillary Services
Agreement, shall continue in full force and effect with respect to Regeneron’s
conduct of the U.S. Praluent Product Business, if the Terminating Party is
Regeneron, or Sanofi’s conduct of the ROW Praluent Product Business, if the
Terminating Party is Sanofi.
(c)Promptly following such effective date, the Parties shall negotiate in good
faith to amend this Agreement as may be needed in order to preserve the
Terminating Party’s rights relating to the U.S. Praluent Product Business, if
the Terminating Party is Regeneron, or to the ROW Praluent Product Business, if
the Terminating Party is Sanofi.
ARTICLE 17
DISPUTE RESOLUTION
17.1 Resolution of Disputes. The Parties recognize that disputes as to certain
matters may from time to time arise that relate to either Party’s rights and
obligations hereunder. It is the objective of the Parties to comply with the
procedures set forth in this Agreement and to use all reasonable efforts to
facilitate the resolution of such disputes in an expedient manner by mutual
agreement. In the event the Parties are unable to resolve any such dispute
(other than a dispute in respect of any final and binding results of any audit
conducted pursuant to Section 8.11 or Section 8.12) either Party may submit such
dispute to the Executive Officers for resolution, specifying the nature of the
dispute with sufficient specificity to permit adequate consideration by such
Executive Officers. The Executive Officers shall diligently and in good faith
attempt to resolve the referred dispute within thirty (30) days of receiving
such written notification. Any final decision mutually agreed to by the
Executive Officers in writing shall be conclusive and binding on the Parties. In
the event the Executive Officers are unable to resolve any such dispute, the
Parties shall be free to pursue any rights and remedies available to them at
law, in equity or otherwise. Nothing in this Section 17.1 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 Party or any of its Affiliates or its or their Sublicensees.
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17.2 Governing Law; Submission to Jurisdiction. This Agreement shall be governed
by and construed in accordance with the Laws of the State of New York, excluding
any conflicts or choice of law rule or principle that might otherwise refer
construction or interpretation of this Agreement to the substantive law of
another jurisdiction. Each Party hereby irrevocably and unconditionally consents
to the exclusive jurisdiction of the courts of the State of New York, and the
United States District Court for the Southern District of New York for any
action, suit or proceeding (other than appeals therefrom) arising out of or
relating to this Agreement, waives any objections to such jurisdiction and venue
and agrees not to commence any action, suit or proceeding relating to this
Agreement except in such courts. Each Party further agrees that service of any
process, summons, notice or document by registered mail to its address set forth
in Schedule 18.4 shall be effective service of process for any action, suit or
proceeding brought against it under this Agreement in any such court.
ARTICLE 18
MISCELLANEOUS
18.1 Compliance With Law. Both Sanofi and Regeneron, and their respective
Affiliates, shall perform their obligations under this Agreement in accordance
with applicable Law. No Party or any of its Affiliates shall, or shall be
required to, undertake any activity under or in connection with this Agreement
that violates, or that it believes, in good faith, may violate, any applicable
Law.
18.2 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 and (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.
18.3 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.
18.4 Notices. All notices or demands required by this Agreement shall be in
writing, shall be sent to the address of the relevant Party set forth on
Schedule 18.4 attached hereto and shall be (a) delivered personally, (b) sent by
registered or certified mail, return receipt requested, postage prepaid, or (c)
sent via a reputable nationwide overnight courier service. 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, or one (1) Business
Day after it is sent via a reputable nationwide overnight courier service.
Either Party may change its notice address by giving notice to the other Party
in the manner provided above.
18.5 Entire Agreement. This Agreement, together with the LCA, the Discovery
Agreement and the Ancillary Agreements, contain the complete understanding of
the Parties with
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respect to the subject matter hereof and thereof and supersedes all prior
understandings and writings relating to the subject matter hereof and thereof.
18.6 Amendments. No provision in this Agreement shall be supplemented, deleted
or amended except in a writing executed by an authorized representative of each
of Sanofi and Regeneron.
18.7 Headings. The descriptive headings of Articles and Sections are inserted
solely for convenience of reference and are not intended as complete or accurate
descriptions of the content of such Articles or Sections.
18.8 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.
18.9 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 13.6.
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.
18.10 Assignment. Each of Sanofi and Regeneron may, without (a) the prior
written consent of Regeneron in the case of any assignment by Sanofi or (b) the
prior written consent of Sanofi in the case of any assignment by Regeneron,
assign any of their respective rights and obligations under this Agreement to
any of its Affiliates or any Third Party, so long as such Affiliate or Third
Party agrees in writing to be bound by the terms of this Agreement; provided,
however, that (i) any such assignment by Sanofi that would entail [* * *] to a
Third Party shall be subject to Regeneron’s prior written consent (not to be
unreasonably withheld, conditioned or delayed) unless such Third Party (A)
acquires whether by merger, sale of assets or otherwise all or substantially all
of Sanofi’s cardio metabolic business, or any successor business unit or
division to which this Agreement relates (which business unit or division does
not include only Praluent Products) and (B) such Third Party acquirer and agrees
in writing to be bound by the terms of this Agreement and (ii) any such
assignment by Regeneron that would entail [* * *] to a Third Party shall be
subject to Sanofi’s prior written consent (not to be unreasonably withheld,
conditioned or delayed) unless such Third Party acquires whether by merger, sale
of assets or otherwise all or substantially all of Regeneron’s cardio metabolic
business, or any successor business unit or division to which this Agreement
relates (which business unit or division does not include only Praluent
Products), and agrees in writing to be bound by the terms of this Agreement.
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18.11 Successors and Assigns. This Agreement shall be binding upon and inure to
the benefit of the Parties and their respective successors and permitted
assigns.
18.12 Affiliates. Each Party may perform its obligations hereunder through one
or more of its Affiliates, although each Party shall nonetheless be responsible
for the performance of its Affiliates. Neither Party shall permit any of its
Affiliates to commit any act (including any act or omission) that such Party is
prohibited hereunder from committing directly.
18.13 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original but that together shall constitute one and the
same instrument. This Agreement may be executed by exchange between the Parties
of electronically transmitted signatures (via facsimile, PDF format via e-mail
or other electronic means) and such signatures shall be deemed to bind each
Party as if they were original signatures.
18.14 No Third Party Beneficiaries. None of the provisions of this Agreement
shall be for the benefit of or enforceable by any Third Party including any
creditor of either Party. 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
either Party.
18.15 Relationship of the Parties. Each Party shall bear its own costs incurred
in the performance of its obligations hereunder without charge or expense to the
other Party except as expressly provided in this Agreement. Neither Sanofi nor
Regeneron shall have any responsibility for the hiring, termination or
compensation of the other Party’s employees or for any employee compensation or
benefits of the other Party’s employees. No employee or representative of a
Party shall have any authority to bind or obligate the other Party to this
Agreement for any sum or in any manner whatsoever, or to create or impose any
contractual or other liability on the other Party without said Party’s approval.
For all purposes, and notwithstanding any other provision of this Agreement to
the contrary, Regeneron’s legal relationship under this Agreement to Sanofi, and
Sanofi’s legal relationship under this Agreement to Regeneron, shall be that of
independent contractor. Nothing in this Agreement shall be construed to
establish a relationship of partners or joint venturers between the Parties or
any of their respective Affiliates.
18.16 Limitation of Damages. IN NO EVENT SHALL REGENERON OR SANOFI BE LIABLE FOR
SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING 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 (a) ARE PAID BY THE OTHER PARTY TO A THIRD PARTY AS PART OF A THIRD
PARTY CLAIM THAT IS COVERED BY SUCH PARTY’S INDEMNIFICATION OBLIGATIONS IN
ARTICLE 14, (b) RELATE TO A BREACH BY SUCH PARTY OF SECTION 5.8, SECTION 6.3(b),
SECTION 18.10 (TO THE EXTENT RELATING TO REGENERON MANUFACTURING KNOW-HOW) OR
ARTICLE 13 OR (c) ARISE AS A RESULT OF SUCH PARTY’S GROSS NEGLIGENCE OR WILLFUL
MISCONDUCT.
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18.17 Rejection of Agreement in Bankruptcy. The Parties intend to take advantage
of the protections of Section 365(n) (or any successor provision) of the U.S.
Bankruptcy Code or any analogous provisions in any other country or jurisdiction
to the maximum extent permitted by applicable Laws. All rights and licenses
granted under or pursuant to this Agreement, but only to the extent they
constitute licenses of a right to “intellectual property” as defined in Section
101 of the U.S. Bankruptcy Code or in any analogous provisions in any other
country or jurisdiction, as applicable, shall be deemed to be “intellectual
property” for the purposes of Section 365(n) or any analogous provisions in any
other country or jurisdiction, as applicable. The Parties shall retain and may
fully exercise all of their rights and elections under the U.S. Bankruptcy Code
or any analogous provisions in any other country or jurisdiction, including the
right to obtain the intellectual property from another entity. In the event of
the commencement of a bankruptcy proceeding by or against either Party under the
U.S. Bankruptcy Code or any analogous provisions in any other country or
jurisdiction, the Party that is not subject to such proceeding shall be entitled
to a complete duplicate of (or complete access to, as appropriate) all such
intellectual property (including all embodiments of such intellectual property),
which, if not already in the non-subject Party’s possession, shall be promptly
delivered to it upon the non-subject Party’s written request (a) upon
commencement of a bankruptcy proceeding, unless the Party subject to such
proceeding continues to perform all of its obligations under this Agreement or
(b) if not delivered pursuant to clause (a) above because the subject Party
continues to perform, upon the rejection of this Agreement by or on behalf of
the subject Party. Unless and until the subject Party rejects this Agreement,
the subject Party shall perform this Agreement or provide the intellectual
property (including all embodiments of such intellectual property) to the
non-subject Party, and shall not interfere with the rights of the non-subject
Party to such intellectual property, including the right to obtain the
intellectual property from another entity.
18.18 Construction.
(a)Except where the context otherwise requires, wherever used, the singular
shall include the plural, the plural the singular, the use of any gender shall
be applicable to all genders. The words “will” and “shall” shall have the same
meaning and the use of the word “or” is used in the inclusive sense (and/or).
The term “including,” “include,” or “includes” as used herein shall mean
including, without limiting the generality of any description preceding such
term, irrespective of whether such term is used with “without limitation” or
“without limiting” elsewhere in this Agreement. Whenever this Agreement refers
to a number of days, unless otherwise specified, such number refers to calendar
days.
(b)Unless otherwise specified, (i) the references in this Agreement to any
Article, Section, Schedule or Exhibit shall mean references to such Article,
Section, Schedule or Exhibit of this Agreement, (ii) references in any section
to any clause are references to such clause of such section and (iii) references
to any agreement, instrument or other document in this Agreement refer to such
agreement, instrument or other document as originally executed or, if
subsequently varied, amended, replaced or supplemented from time to time, so
varied, amended, replaced or supplemented and in effect at the relevant time of
reference thereto.
(c)Whenever a provision of this Agreement requires an approval or consent by a
Party to this Agreement and notification of such approval or consent is not
delivered within
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the applicable time limit, then, unless otherwise specified, the Party whose
approval or consent is required shall be conclusively deemed to have withheld
its approval or consent. This Agreement has been prepared jointly and the
provisions contained herein shall not be construed or interpreted for or against
either Party to this Agreement because such Party drafted or caused such Party’s
legal representative to draft any provision contained herein.
(d)In the event of any conflict between this Agreement and the Schedules and
Appendices hereto, this Agreement shall prevail. In the event of any conflict
between this Agreement and a Praluent Supply Agreement, such Praluent Supply
Agreement shall control in respect of any supply-related terms, and this
Agreement shall control for any other terms.
[SIGNATURE PAGE FOLLOWS.]

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IN WITNESS WHEREOF, Sanofi and Regeneron have caused this Agreement to be
executed by their duly authorized representatives as of the Execution Date.
SANOFI BIOTECHNOLOGY SAS
By /s/ Benedicte Bonny 
Name: Benedicte Bonny
Title: President

REGENERON PHARMACEUTICALS, INC.

By /s/ Robert E. Landry 
Name: Robert E. Landry
Title: Executive Vice President, Finance and Chief Financial Officer

Signature Page to Praluent Cross License & Commercialization Agreement

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Schedules to the Praluent Cross License & Commercialization Agreement

Schedule 1.57
Global Trial Costs
“Global Trial Costs” shall mean, with respect to a Global Clinical Trial, costs
incurred by a Party directly in connection with the conduct of such Global
Clinical Trial in accordance with this Agreement and the applicable Global
Development Plan (as defined under the LCA) in effect under the LCA immediately
prior to the Transition Date and applicable protocol and budget for such Global
Clinical Trial as in effect as of immediately prior to the Transition Date, [* *
*].
For purposes of this Schedule 1.57:
“Global Trial FTE Cost” shall mean, for all clinical Development activities
performed by a Party to conduct any Global Clinical Trials in accordance with
Section 4.2(a), excluding regulatory activities in support thereof, the product
of (a) the number of FTEs used for such Development activities and (b) the
applicable FTE Rate(s).

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Schedule 1.72
Joint Patents
[* * *]

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Schedule 1.135
Regeneron Core Patents
[* * *]

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Schedule 1.156
Sanofi Core Patents
[* * *]

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Schedule 1.180
Transferred Approvals
[* * *]

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

Schedule 1.182
Transferred Product Contracts
[* * *]

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

Schedule 1.183
Transferred Product Domain Names
[* * *]

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Schedule 1.184
Transferred Product Records
[* * *]

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Schedule 1.185
Transferred Product Trademarks
[* * *]

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Schedule 2.3(c)
Approved Contract Manufacturers
Each of companies listed below shall be deemed to include the listed company
(including following any change of name) as well as any of its existing or
future affiliates or successors-in-interest by virtue of mergers or similar
operations.

For use by Regeneron:
[* * *]

For use by Sanofi:
[* * *]

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Schedule 4.2(a)
Global Clinical Trials
[* * *]

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Schedule 4.3
Certain Other Existing Trials
[* * *]

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Schedule 4.4
Certain Investigator-Initiated Studies
[* * *]

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Schedule 4.7
Assay Services
[* * *]

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Schedule 7.2(a)
[* * *]

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Schedule 7.3(a)
Drug Substance Tech Transfer Plan
[* * *]

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Schedule 8.4
Royalty Invoicing Directions
Invoices shall be made out as follows:
[* * *]

And be sent to the following mailing address:
[* * *]

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Schedule 8.5
Transferred Inventory Prices
[* * *]
The prices listed above include all tax and duties, such as sales, export,
import, value added and excise tax or duty.
Sanofi shall issue invoices for Transferred Inventory under this Agreement
consistent with relevant tax requirements.

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Schedule 11.5(a)
Existing Sole Oppositions
[* * *]

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Schedule 11.5(b)
Existing European Oppositions
[* * *]

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Schedule 12.2(c)
Pending or Threatened Litigation or Adverse Agreements
[* * *]

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Schedule 18.4
Notice Addresses

If to Sanofi:

[* * *]

Copy (which shall not constitute notice) to:

[* * *]

If to Regeneron:

[* * *]