Exhibit 10.4.1
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.

CO-CO COLLABORATION AGREEMENT
between
ALNYLAM PHARMACEUTICALS, INC.
and
REGENERON PHARMACEUTICALS, INC.
Dated as of [●], [●]

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

TABLE OF CONTENTS

 
 
 
Article 1
 
DEFINITIONS
Article 2
 
COLLABORATION MANAGEMENT
2.1
 
Joint Steering Committee
2.2
 
Joint Development Committee
2.3
 
Joint Commercialization Committee
2.4
 
Joint Finance Committee
2.5
 
Joint Manufacturing Committee
2.6
 
General Provisions Applicable to Joint Committees
2.7
 
Committees under the Master Agreement and other Co-Co Collaboration Agreements
and License Agreements
2.8
 
Sub-Committees and Working Groups
2.9
 
Discontinuation of Participation on a Committee
2.10
 
Alliance Manager
Article 3
 
DEVELOPMENT AND REGULATORY
3.1
 
Development Activities
3.2
 
Development Costs
3.3
 
Information Exchange
3.4
 
Records and Reports
3.5
 
Opt-Out Rights

3.6
 
Regulatory Matters
3.7
 
Material Transfer
3.8
 
[***]
Article 4
 
COMMERCIALIZATION
4.1
 
In General

4.2
 
Commercialization Plan and Budget
4.3
 
Diligence
4.4
 
Compliance with Applicable Law
4.5
 
Booking of Sales; Distribution
4.6
 
Promotional Materials
4.7
 
Product Trademarks and Domain Names
4.8
 
Use of Corporate Names
4.9
 
Commercialization Reports
4.10
 
Commercialization Costs
Article 5
 
MANUFACTURING AND SUPPLY
5.1
 
Manufacturing Coordination
5.2
 
Early Stage Supply Requirements
5.3
 
Late Stage Supply Requirements
5.4
 
Technology Transfer to Alnylam
5.5
 
Costs of Manufacture
5.6
 
Certain Alnylam Third Party Contractor Requirements
5.7
 
Development of Delivery Systems for Collaboration Products

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

TABLE OF CONTENTS
(continued)

5.8
 
Fill-Finish Manufacturing Activities for Collaboration Products
Article 6
 
GRANT OF RIGHTS
6.1
 
[Grants to Regeneron
6.2
 
[Grants to Alnylam.]
6.3
 
Sublicenses
6.4
 
No Implied License; Retention of Rights
6.5
 
In-License Agreements
6.6
 
Confirmatory Patent License
6.7
 
Exclusivity
Article 7
 
PAYMENTS
7.1
 
Sharing of Development Costs and Profits
7.2
 
Opt-Out Payments
7.3
 
Adjustments to FTE Rates
7.4
 
Invoices and Documentation
7.5
 
Payment Method and Currency
7.6
 
Taxes
7.7
 
Resolution of Payment Disputes
7.8
 
Late Fee
7.9
 
Books and Records
7.10
 
Audits and Adjustments
7.11
 
Accounting Standards
Article 8
 
INTELLECTUAL PROPERTY
8.1
 
Ownership of Intellectual Property
8.2
 
Prosecution and Maintenance of Patents
8.3
 
Enforcement of Patents and Information
8.4
 
Administrative Proceedings
8.5
 
Invalidity or Unenforceability Defenses or Actions
8.6
 
Infringement Claims by Third Parties
8.7
 
Product Trademarks and Domain Names
8.8
 
Discussion of Potential Material Intellectual Property Issues
8.9
 
Intellectual Property that Relates to Multiple Programs
8.10
 
[Transition of Patent Matters
Article 9
 
CONFIDENTIALITY AND NON-DISCLOSURE
9.1
 
Confidentiality Obligations
9.2
 
Permitted Disclosures
9.3
 
Use of Name
9.4
 
Public Announcements
9.5
 
Publications
9.6
 
Return of Confidential Information
9.7
 
Confidential Information that Relates to Multiple Programs
Article 10
 
REPRESENTATIONS AND WARRANTIES
10.1
 
Mutual Representations and Warranties

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

TABLE OF CONTENTS
(continued)

10.2
 
Additional Representations, Warranties and Covenants of Alnylam
10.3
 
Additional Representations and Warranties of Regeneron
10.4
 
DISCLAIMER OF WARRANTIES
10.5
 
Additional Covenants
Article 11
 
INDEMNITY
11.1
 
Indemnity
11.2
 
Indemnity Procedure
11.3
 
Insurance
Article 12
 
TERM AND TERMINATION
12.1
 
Term
12.2
 
Termination for Material Breach
12.3
 
Termination for Insolvency
12.4
 
Rights in Bankruptcy
12.5
 
Additional Lead Party Termination Right
12.6
 
Effects of Termination
12.7
 
Remedies
12.8
 
Accrued Rights; Surviving Obligations
Article 13
 
MISCELLANEOUS
13.1
 
Force Majeure
13.2
 
Assignment
13.3
 
Severability
13.4
 
Governing Law, Jurisdiction and Service
13.5
 
Dispute Resolution
13.6
 
Notices
13.7
 
Entire Agreement; Amendments
13.8
 
LIMITATION OF DAMAGES
13.9
 
Equitable Relief
13.10
 
Waiver and Non-Exclusion of Remedies
13.11
 
No Benefit to Third Parties
13.12
 
Further Assurance
13.13
 
Relationship of the Parties
13.14
 
Counterparts; Facsimile Execution
13.15
 
References
13.16
 
Schedules
13.17
 
Construction

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

CO-CO COLLABORATION AGREEMENT

This Co-Co Collaboration Agreement (this “Agreement”) is made and entered into
effective as of [●], [●] (the “Effective Date”) by and between Alnylam
Pharmaceuticals, Inc., a corporation organized under the laws of Delaware
(“Alnylam”), and Regeneron Pharmaceuticals, Inc., a corporation organized under
the laws of New York (“Regeneron”). Alnylam and Regeneron are sometimes referred
to herein individually as a “Party” and collectively as the “Parties.”
RECITALS

WHEREAS, Alnylam and Regeneron entered into that certain Master Agreement, dated
as of [______ __], 2019 (the “Master Agreement”), pursuant to which, among other
things, Alnylam and Regeneron conducted certain research and development
activities with respect to siRNAs Directed to the Target (as hereinafter
defined) under a Program (as defined in the Master Agreement) for the Target
(the “Target Program”); and
WHEREAS, pursuant to the terms of the Master Agreement, the Parties are now
obligated to enter into a Co-Co Collaboration Agreement (as defined in the
Master Agreement) with respect to the Target Program in order for the Parties to
further collaborate on the research, development and commercialization of
Collaboration Products Directed to the Target on the terms and subject to the
conditions as set forth herein (each initially capitalized term as defined
below).
NOW, THEREFORE, in consideration of the premises and the mutual promises and
conditions hereinafter set forth, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties, intending
to be legally bound, do hereby agree as follows:
Article 1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have
the following meanings:
1.1    “AAA” has the meaning set forth in Schedule 1.
1.2    “Accounting Standards” means, with respect to either Party, generally
accepted accounting principles as applicable in the United States or
International Financial Reporting Standards of the International Accounting
Standards Board, in each case, as generally and consistently applied throughout
such Party’s organization. Each Party shall promptly notify the other Party in
writing if such Party changes the Accounting Standards pursuant to which its
records are maintained.

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1.3    “Acquired Party” has the meaning set forth in Section 6.7.2(a).
1.4    “Acquirer” has the meaning set forth in Section 6.7.2(a).
1.5    “Acquiring Party” has the meaning set forth in Section 6.7.2(a).
1.6    “Acquisition Product” has the meaning set forth in Section 6.7.2(a).
1.7    “Additional Alnylam In-Licenses” means the agreements identified in
Section 2 of Schedule 1.107.
1.8    “Adverse Ruling” has the meaning set forth in Section 12.2.
1.9    “Affiliate” means, with respect to a Person, any Person that, directly or
indirectly, through one or more intermediaries, controls, is controlled by or is
under common control with such first Person for so long as such Person controls,
is controlled by or is under common control with such first Person, regardless
of whether such Affiliate is or becomes an Affiliate on or after the Effective
Date. For purposes of this definition, “control” and, with correlative meanings,
the terms “controlled by” and “under common control with” means (a) the
possession, directly or indirectly, of the power to direct the management or
policies of a business entity, whether through the ownership of voting
securities, by contract relating to voting rights or corporate governance, or
otherwise; or (b) the ownership, directly or indirectly, of more than fifty
percent (50%) of the voting securities or other ownership interest of a business
entity (or, with respect to a limited partnership or other similar entity, its
general partner or controlling entity). 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 or policies of such
entity.
1.10    “Agreement” has the meaning set forth in the preamble hereto.
1.11    “Alliance Manager” has the meaning set forth in Section 2.10.
1.12    “Alnylam” has the meaning set forth in the preamble hereto.
1.13    “Alnylam Background Technology” means (a) Information that is necessary
or reasonably useful to Exploit any Collaboration Product and (b) Patent Rights
that Cover any Collaboration Product or the Exploitation of any Collaboration
Product, in each case, ((a) and (b)), that are Controlled by Alnylam or its
Affiliates during the Term, but excluding Alnylam Collaboration IP and Alnylam’s
interest in the Joint Collaboration IP. [***]

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1.14    “Alnylam Background Technology Improvements” means any developments,
enhancements, modifications or other improvements to, or progeny, mutants,
fragments, or derivatives of the Alnylam Background Technology that (a) are made
by or on behalf of either Party or its Affiliates or its or their Sublicensees
under or in connection with this Agreement, and (b) with respect to any of the
foregoing constituting (i) Information, are not specifically and solely related
to any Product-Specific Factor and (ii) Patent Rights, do not include any claim
the practice of which necessarily requires the presence or direct use of a
Product-Specific Factor.
1.15    “Alnylam Collaboration IP” means (a) any improvement, discovery or
Information, patentable or otherwise, that is conceived or reduced to practice
(in whole or in part) or otherwise identified, discovered, made or developed, as
applicable, solely by individuals who are employees, agents or consultants of
Alnylam or its Affiliates or its or their Sublicensees, in each case, under or
in connection with this Agreement, and (b) any Patent Rights that Cover such
improvements, discoveries or Information described in clause (a). Alnylam
Collaboration IP excludes Alnylam’s interest in Joint Collaboration IP and any
Regeneron Background Technology Improvements. Patent Rights constituting Alnylam
Collaboration IP are either Alnylam Core Technology Patents or Alnylam
Product-Specific Patents, as the case may be.
1.16    “Alnylam Core Technology Know-How” means Alnylam Know-How other than
Alnylam Product-Specific Know-How.
1.17    “Alnylam Core Technology Patents” means Alnylam Patents (other than
Alnylam Product-Specific Patents), including those Patent Rights set forth on
Schedule 1.17.
1.18    “Alnylam Cost Report” has the meaning set forth in Section 7.2.10.
1.19    [“Alnylam Delivery Patents” has the meaning set forth in Section
8.2.3.]1 
1.20    “Alnylam In-License” means any (a) Existing Alnylam In-License;
(b) Product-Specific In-License between Alnylam (or its Affiliates) and a Third
Party entered into after the Effective Date but only to the extent that such
agreement is designated as an Alnylam In-License pursuant to Section 6.5.1(a);
or (c) Core Technology In-License between Alnylam (or its Affiliates) and a
Third Party entered into after the Effective Date but only to the extent such
agreement is designated as an Alnylam In-License pursuant to Section 6.5.1(c) or
Section 6.5.1(d). In the event that a given Product-Specific In-License (as
defined in the Master Agreement) or Core Technology In-License (as defined in
the Master Agreement) between Alnylam (or its Affiliates) and a Third Party was
designated to be an Alnylam In-License (as defined in the Master Agreement) for
the Target Program pursuant to the Master Agreement, then such agreement shall
also be an Alnylam In-License for this Agreement (as a Product-Specific
In-License or Core Technology In-License, as applicable, but shall not be an
Existing Alnylam In-License).
1 Note to Draft: Include this definition only if the Target is a CNS Target.

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1.21    “Alnylam Indemnitees” has the meaning set forth in Section 11.1.2.
1.22    “Alnylam Internal Manufacturing Costs” has the meaning set forth in the
definition of “Minimum Internal Manufacturing Requirements”.
1.23    “Alnylam Know-How” means (a) the Information included in the Alnylam
Collaboration IP; (b) Alnylam’s interest in the Information included in the
Joint Collaboration IP; and (c) the Information included in Alnylam Background
Technology or in any Alnylam Background Technology Improvements that is not in
the public domain or otherwise generally known.
1.24    “Alnylam Managed Patents” has the meaning set forth in Section 10.2.4.
1.25    “Alnylam Manufacturing Technology” means Alnylam Technology relating to
the Manufacturing Process of a Collaboration Product that is Controlled by
Alnylam or its Affiliates during the Term.
1.26    “Alnylam Patents” means (a) the Patent Rights included in the Alnylam
Collaboration IP, (b) Alnylam’s interest in the Joint Collaboration Patents and
(c) the Patent Rights included in any Alnylam Background Technology or in any
Alnylam Background Technology Improvements.
1.27    “Alnylam Product-Specific Know-How” means Alnylam Know-How that is
specifically and solely related to Product-Specific Factors.
1.28    “Alnylam Product-Specific Patents” means the Alnylam Patents that
include at least one claim, the practice of which necessarily requires the
presence or direct use of a Product-Specific Factor, including those Patent
Rights set forth on Schedule 1.28. For clarity, Alnylam Product-Specific Patents
exclude [***].
1.29    “Alnylam siRNA Platform” means Alnylam Background Technology that
relates generally to Alnylam’s siRNA platform and is not primarily related to
any Collaboration Product.
1.30    “Alnylam Specific Activities” means, [***].
1.31    “Alnylam Specific Activities Costs” means, if Alnylam exercises its
Opt-Out Right, the Out-of-Pocket Costs and Development FTE Costs incurred by
Alnylam in accordance with a pre-agreed plan and budget in connection with any
Alnylam Specific Activities after Alnylam exercises its Opt-Out Right, but
excluding, in all cases, any costs with respect to the Ongoing Candidate
Discovery Development Activities. For purposes of the use of the term
“Development FTE Costs” in this definition, references to a Development Plan and
Budget shall be deemed references to the foregoing pre-agreed plan and budget.

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1.32    “Alnylam Technology” means, collectively, Alnylam Know-How and Alnylam
Patents.
1.33    “Alnylam Termination Core Technology Know-How” means Alnylam Termination
Know-How other than Alnylam Termination Product-Specific Know-How.
1.34    “Alnylam Termination Core Technology Patents” means Alnylam Termination
Patents other than Alnylam Termination Product-Specific Patents.
1.35    “Alnylam Termination Know-How” means any Alnylam Know-How existing as of
the effective date of termination of this Agreement that (a) is not in the
public domain or otherwise generally known and (b) is necessary or reasonably
useful to further Exploit a Terminated Product (i) as such Terminated Product
exists as of the effective date of termination of this Agreement or (ii) based
on the Development Plan and Budget in effect as of the effective date of
termination of this Agreement.
1.36    “Alnylam Termination Patents” means (a) any Alnylam Patents existing as
of the effective date of termination of this Agreement that are necessary or
reasonably useful to Exploit a Terminated Product (i) as such Terminated Product
exists as of the effective date of termination of this Agreement or (ii) based
on the Development Plan and Budget in effect as of the effective date of
termination of this Agreement, and (b) any Patent Rights that claim priority to
any Alnylam Patents in clause (a).
1.37    “Alnylam Termination Product-Specific Know-How” means Alnylam
Termination Know-How that is specifically and solely related to Product-Specific
Factors.
1.38    “Alnylam Termination Product-Specific Patents” means the Alnylam
Termination Patents that include at least one claim, the practice of which
necessarily requires the presence or direct use of a Product-Specific Factor.
1.39    “ANDA Act” has the meaning set forth in Section 8.3.5.
1.40    “Anticipated FCS Date” means, with respect to a Collaboration Product
and a country, the date agreed upon by the JSC (or the Executive Officers
pursuant to Section 2.6.3(b) [***]) in advance as the expected date of First
Commercial Sale of such Collaboration Product in such country. The JSC shall
agree upon such date twenty-four (24) months in advance of its expected
occurrence. In the event that Development timelines are shortened such that the
JSC is unable to anticipate the expected date of the applicable First Commercial
Sale twenty-four (24) months in advance of its expected occurrence, the JSC
shall attempt to agree upon the expected date of such First Commercial Sale as
soon as practicable after the JSC determination of the filing date for the Drug
Approval Application for such Collaboration Product in such country.

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1.41    “Anticipated IND Submission Date” has the meaning set forth in
Section 3.1.3(a).
1.42    “API” means any active pharmaceutical (including biological) ingredient
or component (but excluding, for clarity, an adjuvant or excipient).
1.43    “Applicable Law” means applicable laws, rules, and regulations,
including any rules, regulations, guidelines, or other requirements of the
Regulatory Authorities, that may be in effect from time to time.
1.44    “ASO” means a single-stranded antisense oligonucleotide.
1.45    “Baseline Annual Commercialization Plan and Budget” means the initial
Commercialization Plan and Budget approved by the JSC (or the Executive Officers
pursuant to Section 2.6.3(b) [***]) for a given Calendar Year (plus any partial
Calendar Year, if applicable, as set forth in Section 4.2.2(b)) for the binding
portion of such Commercialization Plan and Budget, and any amendment thereto,
that was approved by the JSC by consensus or the Executive Officers pursuant to
Section 2.6.3(b) (i.e., without the Lead Party exercising its final
decision-making authority).
1.46    “Baseline Annual Development Plan and Budget” means, with respect to a
Development Plan and Budget, (a) the initial Pre-Clinical Plan and Budget, the
initial Phase 1 Development Plan and Budget, the initial Phase 2 Development
Plan and Budget or the initial Late Stage Development Plan and Budget, as
applicable, for a given Calendar Year approved by the JSC (or the Executive
Officers pursuant to Section 2.6.3(b) [***]) for the binding portion of such
Development Plan and Budget, and (b) any amendment thereto, that was approved by
the JSC by consensus or the Executive Officers pursuant to Section 2.6.3(b)
(i.e., without the Lead Party exercising its final decision-making authority) or
deemed approved by the Participating Party pursuant to Section 3.2.2(b) [or
approved pursuant to Section 2.6.3(b)(vi)]2.
1.47    “Breaching Party” has the meaning set forth in Section 12.2.
1.48    “Business Day” means a day other than a Saturday, Sunday or another day
of the week on which commercial banks in New York, New York or Boston,
Massachusetts, are authorized or required by Applicable Law to remain closed.
1.49    “Calendar Quarter” means each successive period of three (3) calendar
months commencing on January 1, April 1, July 1 and October 1, except that the
first Calendar Quarter of the Term shall commence on the Effective Date and end
on the day immediately prior to the first to occur of January 1, April 1, July 1
or October 1 after the Effective Date, and the last Calendar Quarter shall end
on the last day of the Term.
2 Note to Draft: Include this bracketed language only in Co-Co Collaboration
Agreements where (1) Alnylam is the initial Lead Party and (2) the Target
Program was a CNS Program under the Master Agreement.

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1.50    “Calendar Year” means each successive period of twelve (12) calendar
months commencing on January 1 and ending on December 31, except that the first
Calendar Year of the Term shall commence on the Effective Date and end on
December 31 of the year in which the Effective Date occurs and the last Calendar
Year of the Term shall commence on January 1 of the year in which the Term ends
and end on the last day of the Term.
1.51    “Change of Control” means, with respect to a Party (or its ultimate
parent), (a) a merger, acquisition, consolidation or reorganization of such
Party (or its ultimate parent) with a Third Party that results in the voting
securities of such Party (or its ultimate parent) outstanding immediately prior
thereto, or any securities into which such voting securities have been converted
or exchanged, ceasing to represent more than fifty percent (50%) of the combined
voting power of the surviving entity or the parent of the surviving entity
immediately after such merger or consolidation, or (b) a transaction or series
of related transactions in which a Third Party, together with its Affiliates,
becomes the “beneficial owner” (as such term is used in Section 13(d) of the
Securities Exchange Act of 1934, as amended, and Rule 13d-3 thereunder (or, in
each case, any successor thereto), except that a Person shall be deemed to have
“beneficial ownership” of all shares that any such Person has the right to
acquire, whether such right may be exercised immediately or only after the
passage of time), directly or indirectly, of more than fifty percent (50%) of
the combined voting power of the outstanding securities of such Party (or its
ultimate parent), or (c) the sale or other transfer to a Third Party, whether
directly or indirectly by a Party or an Affiliate thereof, of all or
substantially all of such Party’s (or its ultimate parent’s) business.
1.52    “Claim” has the meaning set forth in Section 11.1.1.
1.53    “Clinical Data” means all Information with respect to any Collaboration
Product that is made, collected, or otherwise generated under or in connection
with Clinical Trials, including any data, reports, and results with respect
thereto.
1.54    “Clinical Supply Cost” means the Manufacturing Costs for the Early Stage
Supply Requirements or the Late Stage Development Supply Requirements, as
applicable, [***].
1.55    “Clinical Trial” means (a) any Phase 1 Clinical Trial, Phase 2 Clinical
Trial, Phase 3 Clinical Trial or Registration Enabling Trial, (b) such other
tests and studies in human subjects that are required by Applicable Law, or
otherwise recommended by the Regulatory Authorities, to obtain or maintain
Regulatory Approvals for a Collaboration Product for an indication, including
tests or studies that are intended to expand the Product Labeling for such
Collaboration Product with respect to such indication and (c) any open label
extension study of a Collaboration Product.

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1.56    “Co-Co Collaboration Agreement” means any Co-Co Collaboration Agreement
(as defined in the Master Agreement) that is entered into by the Parties (or
their respective Affiliates) pursuant to the Master Agreement, but excluding
this Agreement.
1.57    “Collaboration Product” means any product containing an siRNA Directed
to the Target as a Relevant Organ Product that is Developed under and in
accordance with the Master Agreement or this Agreement [***].
1.58    “Combination Product” means a Collaboration Product that is comprised of
or contains an siRNA Directed to the Target as an API together with one or more
other APIs and is sold either as (i) a fixed dose, (ii) separate doses in a
single package or (iii) separate doses in separate packages but for a single
price.
1.59    “Commercial Overhead Charge” means, [***].
1.60    “Commercial Supply Requirement” means the quantities of Collaboration
Products that are reasonably required to fulfill requirements for commercial
sales in the Territory, and other Commercialization uses with respect to the
Collaboration Products in the Territory.
1.61    “Commercialization” means any and all activities directed to the
preparation for sale of, offering for sale of, or sale of a Collaboration
Product, including activities related to marketing, promoting, distributing, and
importing such Collaboration Product, and interacting with Regulatory
Authorities regarding any of the foregoing after such Collaboration Product has
received Regulatory Approval, including seeking Pricing Approvals, maintaining
Regulatory Approvals, conducting Non-Approval Trials, commercial
pharmacovigilance and health outcomes research and publishing scientific studies
other than in connection with Development. When used as a verb, “to
Commercialize” and “Commercializing” means to engage in Commercialization.
1.62    “Commercialization Budget” has the meaning set forth in Section 4.2.2.
1.63    “Commercialization Plan and Budget” means the three (3) year rolling
comprehensive plan for the worldwide Commercialization of the Collaboration
Products, which shall include the following:
1.63.1    the overall strategy for Commercializing the Collaboration Products,
including target product profiles, branding, positioning, Promotional Materials,
field force size and core messages for the Collaboration Products in the
Territory;
1.63.2    strategies for the Detailing and promotion of the Collaboration
Products in the Territory;
1.63.3    market and sales forecasts for the Collaboration Products;

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1.63.4    Non-Approval Trials; and
1.63.5    anticipated timeline and Commercialization Budget for the
Commercialization of the Collaboration Products.
1.64    “Commercially Reasonable Efforts” means, with respect to the performance
of Development, Commercialization, or Manufacturing activities with respect to a
Collaboration Product by a Party or other applicable activities by a Party
hereunder, the carrying out of such activities in a diligent manner using
efforts and resources [***] devote to products of similar market potential at a
similar stage in development or product life, taking into account all
scientific, commercial, and other factors that such Party and its Affiliates
would take into account, including issues of safety and efficacy, expected and
actual cost and time to develop, expected and actual profitability, expected and
actual competitiveness of alternative products (including generic products) in
the marketplace, the nature and extent of expected and actual market exclusivity
(including patent coverage and regulatory exclusivity), the expected likelihood
of regulatory approval, the expected and actual reimbursability and pricing, and
the expected and actual amounts of marketing and promotional expenditures
required, [***]. “Commercially Reasonable Efforts” shall be determined on a
country-by-country basis.
1.65    “Competing Product” means [***].
1.66    “Competing Product Option” has the meaning set forth in
Section 6.7.2(c).
1.67    “Competing Product Option Data Package” means [***].
1.68    “Competing Program” has the meaning set forth in Section 6.7.2.
1.69    “Competitive Infringement” has the meaning set forth in Section 8.3.1.
1.70    “Confidential Information” has the meaning set forth in Section 9.1.
1.71    “Control” means, with respect to a Party and any item of Information,
Regulatory Documentation, material, Patent Right, or other intellectual property
right, the possession by such Party or any of its Affiliates of the right,
whether directly or indirectly, and whether by ownership, license or otherwise
(other than by operation of the license and other grants in Section 6.1 or
Section 6.2), to grant a license, sublicense or other right (including the right
to reference Regulatory Documentation) to or under such Information, Regulatory
Documentation, material, Patent Right, or other intellectual property right as
provided for herein without violating the terms of any agreement or other
arrangement with any Third Party; provided, that, with respect to rights to any
Third Party’s Information, Patent Rights or other intellectual property rights
that are licensed to, or otherwise obtained by, (a) a Party or its Affiliates
pursuant to a Product-Related In-License entered

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into by such Party or any of its Affiliates after the Effective Date, or (b)
Alnylam or its Affiliates pursuant to any Additional Alnylam In-License, such
Third Party’s Information, Patent Rights or other intellectual property rights
shall be deemed not to be under the Control of such Party or its Affiliates, or
Alnylam or its Affiliates, respectively, unless and until the agreement pursuant
to which such rights are obtained becomes an In-License pursuant to
Section 6.5.1(a), Section 6.5.1(c), Section 6.5.1(d) or Section 6.5.2, as
applicable.
1.72    [***]
1.73    [***]
1.74    “Core Technology In-License” means a Product-Related In-License that is
not a Product-Specific In-License.
1.75    “Corporate Names” means (a) with respect to Alnylam, the Trademarks and
logos as Alnylam may designate in writing to Regeneron from time to time and (b)
with respect to Regeneron, the Trademarks and logos as Regeneron may designate
in writing to Alnylam from time to time.
1.76    “Cost of Goods Sold” means, with respect to a given Calendar Quarter,
the aggregate Manufacturing Costs (calculated in accordance with Accounting
Standards and Schedule 1.165) for all Collaboration Products sold in the
Territory during such Calendar Quarter; [***].
1.77    “Cover” or “Covering” means, as to a product and Patent Rights, that, in
the absence of a license granted under, or ownership of, such Patent Rights, the
manufacture, use, offer for sale, sale, importation or other Exploitation of
such product would infringe such Patent Rights or, as to a pending claim
included in such Patent Rights, the manufacture, use, offer for sale, sale,
importation or other Exploitation of such product would infringe such Patent
Rights if such pending claim were to issue in an issued patent.
1.78    “Damages” has the meaning set forth in Section 11.1.1.
1.79    “Deadlocked Dispute” has the meaning set forth in Section 2.6.3(b)(ii).
1.80    “Default Notice” has the meaning set forth in Section 12.2.
1.81    “Detail” means a face-to-face contact between a sales representative and
a physician or other medical professional licensed to prescribe drugs (including
a nurse practitioner or physician assistant with prescribing authority) (a
“Healthcare Prescriber”), but excluding, for clarity: (a) e-details; (b)
presentations made at conventions or to any group of more than five (5)
Healthcare Prescribers or other office staff members involved in the prescribing
or reimbursement of a Collaboration Product; (c) a delivery of savings cards or
coupons without discussion with a

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Healthcare Prescriber or other office staff member involved in the prescribing
or reimbursement of a Collaboration Product; and (d) activities of medical
science liaisons. When used as a verb, “Detail” or “Detailing” means to engage
in a Detail.
1.82    “Development” means all activities related to research, pre-clinical and
other non-clinical testing, test method development and stability testing,
toxicology, formulation, process development, Manufacturing scale-up,
qualification and validation (but excluding such scale-up, qualification and
validation with respect to establishing, or otherwise causing to become
operational, any Manufacturing facilities), quality assurance/quality control,
Clinical Trials, including Manufacturing in support thereof, statistical
analysis and report writing, the preparation and submission of Drug Approval
Applications, regulatory affairs with respect to the foregoing, medical affairs,
medical information, medical education, health economic and outcomes research,
market research, and all other activities necessary or reasonably useful or
otherwise requested or required by a Regulatory Authority as a condition or in
support of obtaining or maintaining a Regulatory Approval. Development also
includes the foregoing activities, if any, with respect to any devices
(including diagnostics) designed for use with a Collaboration Product (which
activities, if any, shall be set forth in the relevant Development Plan and
Budget). Development does not include conducting Non-Approval Trials. When used
as a verb, “Develop” means to engage in Development.
1.83    “Development Budget” has the meaning set forth in Section 3.1.7(a).
1.84    “Development Costs” means the sum of the following items, in each case,
incurred by a Party for the Development of the Collaboration Products in
accordance with this Agreement and the applicable Development Plan and Budget:
1.84.1    Out-of-Pocket Costs (including fees and expenses) for obtaining INDs
and Regulatory Approvals for the Collaboration Products under this Agreement;
1.84.2    Development FTE Costs;
1.84.3    Out-of-Pocket Costs without markup for contractors performing
Development activities under this Agreement;
1.84.4    Out-of-Pocket Costs related to Clinical Trials conducted pursuant to a
Development Plan and Budget, including the Out-of-Pocket Cost of clinical
research organizations, investigator and expert fees, lab fees and scientific
service fees, the Out-of-Pocket Cost of shipping clinical supplies to centers or
disposal of clinical supplies, in each case, to the extent not already included
in the Clinical Supply Costs;
1.84.5    Clinical Supply Costs;

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1.84.6    Out-of-Pocket Costs incurred for (a) Manufacturing process,
formulation, cleaning, and shipping development and validation, (b)
Manufacturing scale-up and improvements, (c) stability testing, (d) quality
assurance/quality control development, and (e) internal and Third Party costs
and expenses incurred in connection with (i) qualification and validation of
Third Party contract manufacturers and vendors (including Third Party fillers,
packagers, labelers, distributors and warehousing) and (ii) subject to the terms
of this Agreement, establishing a primary or secondary source supplier,
including, the transfer of process and Manufacturing technology and analytical
methods, scale-up to First Commercial Sale, process and equipment validation,
cleaning validation and initial Manufacturing licenses, approvals and Regulatory
Authority inspections and obtaining any comparator agent or product for use in
Clinical Trials (in each case, to the extent not included in Clinical Supply
Costs or Cost of Goods Sold); in each case for a Collaboration Product under
this Agreement, except that unless otherwise agreed to by the Parties, any
capital expenditures incurred in providing capacity for the Manufacture of
Collaboration Products, including costs related to validation batches that are
the first validation for the applicable Manufacturing facility, shall be treated
in accordance with Schedule 1.165 and shall not be included as Development
Costs; provided that notwithstanding the foregoing, except with respect to the
Manufacturing Technology Transfer Costs (which shall be handled in accordance
with Section 5.5.1) [***];
1.84.7    any In-License Payments to the extent attributable to the Development
of Collaboration Products (to the extent not otherwise included in Shared
Commercial Expenses); and
1.84.8    any other costs or expenses directly related and specifically
attributable to the Development of a Collaboration Product and specifically
identified and included in a Development Plan and Budget or included as
Development Costs under or in connection with this Agreement.
If any of the foregoing costs benefit both Collaboration Product(s) and other
products or activities of a Party (for example, if an In-License is not
exclusively of benefit to Collaboration Products), then the applicable Party
incurring such costs shall apportion such costs in a manner that fairly and
reasonably reflects the benefit to the Collaboration Products and the other
products or activities of such Party; provided that, notwithstanding the
foregoing, [***]. Each Party shall disclose both the total costs incurred and
the apportionment in the information reported under Section 7.1.3(b) for review
by the other Party. At the request of the other Party, the Party making the
apportionment shall provide additional reasonable supporting documentation and
make its personnel reasonably available to answer questions. Any dispute
regarding such apportionment shall be a Financial Dispute.
In no event shall the same costs be included more than once in Development Costs
under this Agreement, even if such costs are of benefit to multiple
Collaboration Products.

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1.85    “Development Data” has the meaning set forth in Section 3.4.2.
1.86    “Development FTE Cost” means, for all Development activities performed
in accordance with a Development Plan and Budget, including regulatory
activities, the product of (a) the number of FTEs required for such Development
activities as set forth in such approved Development Plan and Budget and (b) the
Development FTE Rate. For the avoidance of doubt, the activity of contract
personnel shall be charged as Out-of-Pocket Costs without markup.
1.87    “Development FTE Rate” means [***] in the Calendar Year ending December
31, 2019, such amount to be adjusted as of January 1, 2020 and annually
thereafter by the average of the percentage increases or decreases, if any, in
the U.S. CPI for the twelve (12) months ending June 30 of the Calendar Year
prior to the Calendar Year for which the adjustment is being made. The
Development FTE Rate shall be inclusive of FTE Costs and Expenses. The JFC may
determine a separate FTE rate for Development personnel located outside the
United States, including an appropriate indexed adjustment mechanism with
respect thereto.
1.88    “Development Payment Report” means the report prepared by the Lead Party
each Calendar Quarter in accordance with Section 7.1.3(f) that sets forth in
reasonable detail, (a) the Development Costs incurred by the Parties for such
Calendar Quarter and (b) the Quarterly Development True-Up for such Calendar
Quarter calculated in accordance with Schedule 7.1.1. If an item is included in
one Development Payment Report, in no event shall the same item be included in a
subsequent Development Payment Report.
1.89    “Development Phase Budget” means, with respect to a Development Plan and
Budget, the number expressed in Dollars that is equal to the estimated total
Development Costs for the corresponding Development Phase Budget Period set
forth in (a) the initial Pre-Clinical Plan and Budget, or the initial Phase 1
Development Plan and Budget, or the initial Phase 2 Development Plan and Budget,
or the initial Late Stage Development Plan and Budget, as applicable, approved
by the JSC (or the Executive Officers pursuant to Section 2.6.3(b) [***]) and
(b) any amendment to any such estimates approved by the JSC by consensus or the
Executive Officers pursuant to Section 2.6.3(b) (i.e., without the Lead Party
exercising its final decision-making authority) or deemed approved by the
Participating Party pursuant to Section 3.2.2(b) [or approved pursuant to
Section 2.6.3(b)(vi)]3.

3 Note to Draft: Include this bracketed language only in Co-Co Collaboration
Agreements where (1) Alnylam is the initial Lead Party and (2) the Target
Program was a CNS Program under the Master Agreement.

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1.90    “Development Phase Budget Period” means (a) with respect to the
Pre-Clinical Development Plan and Budget, the period from the Effective Date
through the acceptance by the applicable Regulatory Authority in a Major Market
Country (or the EMA pursuant to the centralized approval procedure, or in any
other country identified in the Pre-Clinical Plan and Budget in which the
Parties intend to file an IND for a Collaboration Product) of the first IND for
the first Collaboration Product, (b) with respect to the Phase 1 Development
Plan and Budget, the period beginning immediately after the acceptance by the
applicable Regulatory Authority in a Major Market Country (or the EMA pursuant
to the centralized approval procedure, or in any other country identified in the
Pre-Clinical Plan and Budget in which the Parties intend to file an IND for a
Collaboration Product) of the first IND for the first Collaboration Product and
continuing up to the Phase 1 Completion Date, (c) with respect to the Phase 2
Development Plan and Budget, the period beginning immediately after the Phase 1
Completion Date and continuing up to the Phase 2 Completion Date and (d) with
respect to the Late Stage Development Plan and Budget, beginning immediately
after the Phase 2 Completion Date and continuing up to the Anticipated FCS Date
in the first Major Market Country.
1.91    “Development Plan and Budget” means each of the Pre-Clinical Plan and
Budget, the Phase 1 Development Plan and Budget, Phase 2 Development Plan and
Budget and the Late Stage Development Plan and Budget.
1.92    “Direct Costs” has the meaning set forth in Schedule 1.165.
1.93    “Directed to” means, with respect to siRNA and the Target, that such
siRNA binds to and interferes with the function of any messenger RNA encoded by
the Target. For clarity, [***].
1.94    “Divestment Period” has the meaning set forth in Section 6.7.2(b).
1.95    “Dollars” or “$” means United States Dollars.
1.96    “Drug Approval Application” means a New Drug Application (an “NDA”) as
defined in the FFDCA, or any corresponding foreign application in the Territory,
including, with respect to the European Union, a Marketing Authorization
Application (an “MAA”) filed with the EMA pursuant to the centralized approval
procedure or with the applicable Regulatory Authority of a country in Europe
with respect to the mutual recognition or any other national approval procedure.
1.97    “Early Stage Supply Requirements” means the quantities of Collaboration
Products (and placebo) that are reasonably required by either Party to perform
its Development activities under the Pre-Clinical Plan and Budget, Phase 1
Development Plan and Budget and Phase 2 Development Plan and Budget.

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1.98    “Effective Date” means the effective date of this Agreement as set forth
in the preamble hereto.
1.99    “EMA” means the European Medicines Agency and any successor agency
thereto.
1.100    “European Union” means the organization of member states of the
European Union, as it may be constituted from time to time; provided that for
the purposes of this Agreement the United Kingdom and any other country that is
a member of the European Union on the Effective Date, shall be deemed to be a
member of the European Union even if such country ceases to be a member of the
European Union during the term of this Agreement.
1.101    “Excess Commercialization Costs” has the meaning set forth in
Section 4.10.2.
1.102    “Excess Development Costs” has the meaning set forth in
Section 3.2.2(a).
1.103    “Excluded Agreements” means the agreements set forth on Schedule 1.103.
1.104    “Excluded Collaboration Technology” has the meaning set forth in
Section 6.7.3(a).
1.105    “Executive Officer” means, with respect to Alnylam, its Chief Executive
Officer, and with respect to Regeneron, its Chief Executive Officer.
1.106    “Existing Alnylam CMOs” means each of the Third Party contract
manufacturers set forth on Schedule 1.106 and their respective Affiliates,
successors and assigns.4
1.107    “Existing Alnylam In-Licenses” means the Third Party agreements
identified in Section 1 of Schedule 1.107,5 and any Additional Alnylam
In-License included within the definition of Existing Alnylam In-Licenses
pursuant to Section 6.5.2. For clarity, the Existing Alnylam In-Licenses do not
include the Excluded Agreements.
1.108    “Existing Alnylam Third Party Agreements” means the agreements
identified on Schedule 1.108.6 
1.109    “Existing Regeneron In-Licenses” means the Third Party agreements
identified on Schedule 1.109.7 
4 Note to Draft: Schedule 1.106 to include only those Existing Alnylam CMOs
under the Master Agreement with respect to the Target Program.
5 Note to Draft: Schedule 1.107 to include only those Existing Alnylam
In-Licenses under the Master Agreement with respect to the Target Program
(either Part 1 or Part 2 of the Schedule of Existing Alnylam In-Licenses to the
Master Agreement).
6 Note to Draft: Schedule 1.108 to include only those Existing Alnylam Third
Party Agreements under the Master Agreement with respect to the Target Program.
7 Note to Draft: Schedule 1.109 to include only those Existing Regeneron
In-License under the Master Agreement with respect to the Target Program (either
Part 1 or Part 2 of the Schedule of Existing Regeneron In-Licenses to the Master
Agreement).

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1.110    “Existing Regeneron Third Party Agreements” means the agreements
identified on Schedule 1.110.8 
1.111    “Expedited Matter” has the meaning set forth in Schedule 1.
1.112    “Expert” has the meaning set forth on Schedule 2.
1.113    “Expert Dispute” has the meaning set forth in Section 2.6.3(b)(v).
1.12    “Exploit” means, with respect to a product, to make, have made, import,
use, sell, or offer for sale, including to research (including pre-clinical and
clinical research), Develop, Commercialize, register, Manufacture, have
Manufactured, hold, or keep (whether for disposal or otherwise), have used,
export, transport, distribute, promote, market, or have sold or otherwise
dispose of such product. When used as a noun, “Exploitation” means the act of
Exploiting a product.
1.115    “FDA” means the United States Food and Drug Administration and any
successor agency thereto.
1.116    “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act,
as amended from time to time, together with any rules, regulations and
requirements promulgated thereunder (including all additions, supplements,
extensions, and modifications thereto).
1.117    “Field” means all human diagnostic, prophylactic, and therapeutic uses.
1.118    “Field Force Cost” means, for a given Collaboration Product in a
country, the product of (a) the number of Lead Party’s FTEs conducting Details,
performing account management, medical science liaison, medical affairs, nurse
trainers or access and reimbursement specialist functions, in each case, in
accordance with this Agreement and the Commercialization Plan and Budget and (b)
the applicable Field Force FTE Rate(s), in each case, with respect to such
country. For the avoidance of doubt, the activities of Third Party contract
personnel, shall be charged as Out-of-Pocket Costs and not included in the Field
Force Cost.
1.119    “Field Force FTE Rates” means, [***].

8 Note to Draft: Schedule 1.110 to include only those Existing Regeneron Third
Party Agreements under the Master Agreement with respect to the Target Program.

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1.120    “Financial Dispute” means any dispute related to a Party’s method of
calculation of Development Costs, any element included in the Profit Split or
element to determine the Royalties payable, including (a) any apportionment of
costs and expenses included therein, including a Party’s method of calculation
of Other Shared Expenses or Shared Commercial Expenses, (b) with respect to any
In-License that is applicable to products other than the Collaboration Products,
the allocation of the In-License Payments with respect to such In-License to the
Exploitation of Collaboration Products, (c) the budget for any Alnylam Specific
Activities Costs to be negotiated by the Parties if Alnylam exercises its
Opt-Out Right, as further described in Section 3.5.7(b), and (d) any
apportionment of revenues from a Combination Product that contains a Proprietary
Unlicensed Component as contemplated in Section 7.1.1.
1.121    “Financial Expert” has the meaning set forth in Section 13.5.2(a).
1.122    “First Commercial Sale” means, with respect to a Collaboration Product
and a country, the first sale by or on behalf of the Lead Party for monetary
value for use or consumption by the end user of such Collaboration Product in
such country after Regulatory Approval (other than Pricing Approvals) for such
Collaboration Product has been obtained in such country. Sales prior to receipt
of Regulatory Approval for such Collaboration Product, such as so-called
“treatment IND sales,” “named patient sales,” “early access programs,”
“temporary use authorization programs,” and “compassionate use sales,” shall not
be construed as a First Commercial Sale.
1.123    “FTE” means a full time equivalent employee (i.e., one fully-committed
or multiple partially-committed employees aggregating to one full-time employee)
employed by a Party (or any of its Affiliates) and assigned to perform specific
work, with such commitment of time and effort to constitute one employee
performing such work on a full-time basis, which for purposes hereof shall be
1800 hours per year.
1.124    “FTE Costs and Expenses” means [***].
1.125    “Generic Product” means, with respect to a particular Collaboration
Product in a particular country in the Territory, any product that (a) is
distributed by a Third Party under a separate Drug Approval Application approved
by a Regulatory Authority in reliance, in whole or in part, on the Drug Approval
Application for such Collaboration Product in such country (or on safety or
efficacy data submitted in support of the Drug Approval Application for such
Collaboration Product in such country), including any product authorized for
sale (i) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the
FFDCA (21 U.S.C. § 355(b)(2) and 21 U.S.C. § 355(j), respectively), (ii) in the
European Union pursuant to a provision of Articles 10, 10a or 10b of Parliament
and Council Directive 2001/83/EC as amended (including an application under
Article 6.1 of Parliament and Council Regulation (EC) No. 726/2004 that relies
for its content on any such provision) or (iii) in any other country or
jurisdiction pursuant to an equivalent of such provisions or (b) is

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substitutable under Applicable Law for such Collaboration Product when dispensed
without the intervention of a physician or other health care provider with
prescribing authority.
1.126    “Good Manufacturing Practice” or “GMP” means the current good
manufacturing practices applicable from time to time to the manufacturing of a
Collaboration Product or any intermediate thereof pursuant to Applicable Law.
1.127    “Healthcare Prescriber” has the meaning set forth in the definition of
“Detail.”
1.128    “In-License” means (a) any Alnylam In-License, and (b) any Regeneron
In-License.
1.129    “In-License Payments” means [***].
1.130    “IND” means (a) an investigational new drug application filed with the
FDA for authorization to commence Clinical Trials and its equivalent in other
countries or regulatory jurisdictions, and (b) all supplements and amendments
that may be filed with respect to the foregoing.
1.131    “Indemnified Party” has the meaning set forth in Section 11.2.1.
1.132    “Indemnifying Party” has the meaning set forth in Section 11.2.1.
1.133    “Indirect Costs” has the meaning set forth in Schedule 1.165.
1.134    “Information” means all technical, scientific, and other know-how and
information, trade secrets, knowledge, technology, means, methods, processes,
practices, formulae, instructions, skills, techniques, procedures, experiences,
ideas, technical assistance, designs, drawings, assembly procedures, computer
programs, apparatuses, specifications, data, results and Materials, including:
biological, chemical, pharmacological, toxicological, pharmaceutical, physical
and analytical, pre-clinical, clinical, safety, manufacturing and quality
control data and information, including study designs and protocols; assays; and
biological methodology; in each case (whether or not confidential, proprietary,
patented or patentable) in written, electronic or any other form now known or
hereafter developed.
1.135    “Infringement Action” has the meaning set forth in Section 8.3.2.
1.136    “Initiation” or “Initiate” means, with respect to a Clinical Trial, the
first dosing of the first human subject in such Clinical Trial.
1.137    “Joint Collaboration IP” means (a) any improvement, discovery or
Information, patentable or otherwise, that are conceived or reduced to practice
(in whole or in part) or otherwise identified, discovered, made or developed, as
applicable, jointly by individuals who are employees, agents or consultants of
Alnylam or its Affiliates or its or their Sublicensees, on the one hand, and

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individuals who are employees, agents or consultants of Regeneron or its
Affiliates or its or their Sublicensees, on the other hand, under or in
connection with this Agreement, and (b) any Patent Rights that Cover such
improvements, discoveries or Information described in clause (a) (the “Joint
Collaboration Patents”). Joint Collaboration IP also includes any Joint
Collaboration IP (as defined in the Master Agreement) from the Master Agreement
with respect to the Target Program. Joint Collaboration IP excludes any Alnylam
Background Technology Improvements and any Regeneron Background Technology
Improvements.
1.138    “Joint Collaboration Patents” has the meaning set forth in the
definition of “Joint Collaboration IP.”
1.139    “Joint Commercialization Committee” or “JCC” has the meaning set forth
in Section 2.3.1.
1.140    “Joint Committee” means each of the Joint Steering Committee, Joint
Development Committee, Joint Commercialization Committee, Joint Finance
Committee and Joint Manufacturing Committee.
1.141    “Joint Development Committee” or “JDC” has the meaning set forth in
Section 2.2.1.
1.142    “Joint Finance Committee” or “JFC” has the meaning set forth in
Section 2.4.1.
1.143    “Joint Manufacturing Committee” or “JMC” has the meaning set forth in
Section 2.5.1.
1.144    “Joint Steering Committee” or “JSC” has the meaning set forth in
Section 2.1.1.
1.145    “JSC Dispute” means a dispute that arises with respect to an issue
within the jurisdiction of the JSC.
1.146    “Knowledge” means, with respect to a Party, the actual knowledge of (i)
such Party’s internal legal department (including such legal department’s
intellectual property group), (ii) any employees of such Party who were directly
involved in the negotiation of this Agreement with the other Party or who were
directly involved in the preparation of such Party’s Program Data Package (as
defined in the Master Agreement) for the Target Program pursuant to the Master
Agreement or (iii) any member of such Party’s senior management.
1.147    “Late Stage Development Plan and Budget” means, (a) beginning
immediately after the Phase 2 Completion Date through First Commercial Sale in
the first Major Market Country, the development plan setting forth in reasonable
detail (i) the comprehensive plan for the Development of the Collaboration
Products for Commercialization in the Territory during such

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period, including the applicable Development Phase Budget, and (ii) the rolling
[***] plan of specific Development activities to be performed with respect to
the Collaboration Products and the anticipated timeline and Development Budget,
or (b) beginning with the First Commercial Sale in the first Major Market
Country, the rolling [***] plan of specific Development activities to be
performed with respect to the Collaboration Products and the anticipated
timeline and Post-Approval Development Budget. Such plan shall allocate
responsibility for such Development activities between the Parties; provided,
that the Parties anticipate that the Lead Party shall be primarily responsible
for conducting all Development activities set forth in the Late Stage
Development Plan and Budget; provided further that if Regeneron is the Lead
Party, Alnylam shall be responsible for the Alnylam Specific Activities set
forth in the Late Stage Development Plan and Budget. The initial Late Stage
Development Plan and Budget is expected to include any ongoing Development
activities set forth in the Phase 2 Development Plan and Budget that have not
been completed as of the Phase 2 Completion Date. [***]
1.148    “Late Stage Development Supply Requirements” means the quantities of
Collaboration Products (and placebo) that are reasonably required by either
Party to perform its Development activities under the Late Stage Development
Plan and Budget.
1.149    “Late Stage Supply Requirements” means the Late Stage Development
Supply Requirements and Commercial Supply Requirements.
1.150    “Lead Party” means [________]9 unless and until such Party exercises
its Opt-Out Right, in which case [________]10 becomes the Lead Party from and
after the date of such exercise.
1.151    “Lead Party Indemnitees” has the meaning set forth in Schedule 12.6(B).
1.152    “Lead Party Quarterly Expenses” has the meaning set forth in
Schedule 7.1.1.
1.153    “Lead Party Termination Core Technology Know-How” has the meaning set
forth in Schedule 12.6(B).
1.154    “Lead Party Termination Core Technology Patents” has the meaning set
forth in Schedule 12.6(B).
1.155    “Lead Party Termination Product-Specific Know-How” has the meaning set
forth in Schedule 12.6(B).
9 Note to Draft: Insert the name of the Party (either Alnylam or Regeneron) that
is designated the Lead Party for this Agreement in accordance with the Master
Agreement.
10 Note to Draft: Insert the name of the Party (either Regeneron or Alnylam)
that is not designated the Lead Party for this Agreement in accordance with the
Master Agreement.

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1.156    “Lead Party Termination Product-Specific Patents” has the meaning set
forth in Schedule 12.6(B).
1.157    “Lead Patent Party” means the Lead Party (which, for clarity, may be
the New Lead Party if the initial Lead Party exercises its Opt-Out Right).
1.158    “Legal Dispute” means any dispute related to a Party’s alleged material
breach of this Agreement or the validity, breach, termination or interpretation
of this Agreement, or intellectual property-related disputes.
1.159    “License Agreement” means (i) any License Agreement (as defined in the
Master Agreement) that is entered into by the Parties (or their respective
Affiliates) pursuant to the Master Agreement and [***].
1.160    [***]
1.161    “MAA” has the meaning set forth in the definition of “Drug Approval
Application.”
1.162    “Major Market Country” means each of the United States, Japan, France,
Germany, Italy, the United Kingdom and Spain.
1.163    “Major Regulatory Filings” has the meaning set forth in
Section 3.6.1(c)(i).
1.164    “Manufacture” and “Manufacturing” means all activities related to the
production, manufacture, processing, filling, finishing, packaging, labeling,
assembling, shipping, and holding of any Collaboration Product, or any
intermediate thereof, and any placebo, as the case may be (including any devices
or other delivery technologies that are packaged or distributed with a
Collaboration Product), including process development, process qualification and
validation, scale-up, pre-clinical, clinical and commercial manufacture and
analytic development, product characterization, stability testing, quality
assurance, and quality control, and management of any Third Party contractors
conducting such activities.
1.165    “Manufacturing Cost” has the meaning set forth on Schedule 1.165.
1.166    “Manufacturing Plan” means, with respect to a Collaboration Product, a
manufacturing plan setting forth process and technology selection, process
improvements and all related process development activities that impact
Manufacturing of a Collaboration Product, including a plan for a second source
manufacturer for Collaboration Products and shall be designed to ensure
reasonably adequate supply of the Early Stage Supply Requirements and the Late
Stage

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Supply Requirements. Each Manufacturing Plan will further set forth the
estimated capacity requirements to meet forecasted demand over an ensuing period
of at least [***] Calendar Years. The initial Manufacturing Plan will cover at
least the initial expected Early Stage Supply Requirements for Collaboration
Products.
1.167    “Manufacturing Process” means the then-current process for the
Manufacture of Collaboration Products.
1.168    “Manufacturing Technology Transfer” has the meaning set forth in
Section 5.3.3.
1.169    “Manufacturing Technology Transfer Costs” means the FTE Costs and
Expenses and Out-of-Pocket Costs incurred by either Party in connection with a
Manufacturing Technology Transfer pursuant to Section 5.2.2, Section 5.3.3(a) or
Section 5.3.3(b). Manufacturing Technology Transfer Costs do not include the
costs with respect to any Manufacturing Technology Transfer requested by
Regeneron due to a Material Supply Failure (which costs, for clarity, will be
borne by Alnylam), unless such Material Supply Failure is caused by or results,
in whole or part, from an event of force majeure (as described in Section 13.1
of this Agreement) that applies to Alnylam, its Affiliate or its Third Party
contract manufacturer(s), in which case, such costs are Manufacturing Technology
Transfer Costs.
1.170    “Material Supply Failure” means, [***], with respect to a Collaboration
Product, [***] failure to deliver [***] at least [***] of the quantity of
Collaboration Product in accordance with the specifications as ordered in a
[***] period in accordance with the forecasting and ordering procedures in the
Supply Agreement [***]. The Parties acknowledge that as of the Effective Date no
Manufacturing Process has been developed, and no [***] has been selected, for
the Manufacture of Collaboration Product at scale. Therefore, the Parties may
discuss in good faith reasonable modifications to the quantitative standard for
Material Supply Failure in this definition for inclusion in the Supply
Agreement, based on forecast, lead time, the Lead Party’s supply requirements,
[***] manufacturing slot availability, batch/order size and other relevant
considerations known.
1.171    “Materials” means all tangible compositions of matter, devices,
articles of manufacture, assays, animal models, biological, chemical, or
physical materials, and other similar materials, including cell lines and animal
models; provided that “Materials” excludes Collaboration Products.
1.172    “MicroRNA” or “miRNA” means a structurally defined functional RNA
molecule usually between nineteen (19) and twenty-five (25) nucleotides in
length, which is derived from an endogenous, genetically-encoded non-coding RNA
which is predicted to be processed into a hairpin RNA structure that is a
substrate for the double-stranded RNA-specific ribonuclease drosha and
subsequently is predicted to serve as a substrate for the enzyme dicer, a member
of the RNase III enzyme family.

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1.173    “MicroRNA Mimic” means a single-stranded or double-stranded
oligonucleotide with the same or substantially similar base composition and
sequence (including chemically modified bases) as a particular natural miRNA and
which is designed to mimic the activity of such miRNA. For clarity, MicroRNA
Mimic excludes a double-stranded oligonucleotide which functions or is designed
to function as an siRNA.
1.174    “Minimum Internal Manufacturing Requirements” means if either Alnylam
or Regeneron, as applicable, desires to Manufacture Collaboration Product
directly (either itself or through an Affiliate) rather than through a Third
Party contract manufacturer, that such Party (or its Affiliate, as applicable)
satisfies all of the following:
1.174.1    [***]
1.174.2    the quality, compliance and reliability with respect to the
Manufacture of Collaboration Product directly by such Party (or its Affiliate)
is reasonably expected to be comparable to or better than the quality,
compliance and reliability with respect to the Manufacture of Collaboration
Product by other Third Party contract manufacturers who have experience
manufacturing siRNAs;
1.174.3    the facility at which such Party (or its Affiliate) will Manufacture
Collaboration Product satisfies industry standards as demonstrated by the
results of a reasonably recent qualification audit; and
1.174.4     the facility at which such Party (or its Affiliate) will Manufacture
Collaboration Product will be timely validated, fully operational and have
sufficient capacity to Manufacture the Early Stage Supply Requirements or Late
Stage Supply Requirements, as applicable.
1.175    “NDA” has the meaning set forth in the definition of “Drug Approval
Application.”
1.176    “Net Sales” means, [***]
1.177    “New External Program” has the meaning set forth in Section 3.1.15.
1.178    “New Lead Party” has the meaning set forth in Schedule 3.5.7(a).
1.179    “New Program Permitted Dual Sequence Uses” has the meaning set forth in
Section 3.1.15.
1.180    “Non-Acquiring Party” has the meaning set forth in Section 6.7.2(a).

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1.181    “Non-Approval Trials” means any surveys, registries and Clinical Trials
not intended to gain Regulatory Approval or any additional labeled indications,
excluding any open label extension studies of the Collaboration Products.
1.182    “Non-Breaching Party” has the meaning set forth in Section 12.2.
1.183    “Non-Relevant Organ Delivery Technology” means [***].
1.184    “Ongoing Candidate Discovery Activities” has the meaning set forth in
the definition of “Pre-Clinical Plan and Budget.”
1.185    “Opt-Out Date” has the meaning set forth in Section 3.5.1.
1.186    “Opt-Out Development Costs” has the meaning set forth in
Section 3.5.7(g).
1.187    “Opt-Out Notice” has the meaning set forth in Section 3.5.1.
1.188    “Opt-Out Party” had the meaning set forth in Section 3.5.7.
1.189    “Opt-Out Right” has the meaning set forth in Section 3.5.1.
1.190    “Opt-Out Transition Agreement” has the meaning set forth in
Schedule 3.5.7(a).
1.191    “Opt-Out Transition Costs” has the meaning set forth in
Schedule 3.5.7(a).
1.192    “Option Threshold” means, [***].
1.193    “Other Shared Expenses” means, with respect to a Collaboration Product,
(a) Shared Claims and Shared Damages, (b) those costs and expenses incurred by a
Party that are specifically referred to in Section 3.6.2, Section 5.5.1,
Section 8.2.1, Section 8.2.6, Section 8.3.2, Section 8.5.6, Section 8.6.4,
Section 8.7.1, Section 11.1.3, Section 11.2.3 and Section 11.2.5 and (c) other
costs agreed between the Parties in writing to be included therein, to the
extent that such costs and expenses do not include any costs and expenses
included in Development Costs or Shared Commercial Expenses. If any of the
foregoing costs benefit both Collaboration Product(s) and other products or
activities of a Party (for example, if an In-License is not exclusively of
benefit to Collaboration Products), then the applicable Party incurring such
costs shall apportion such costs in a manner that fairly and reasonably reflects
the benefit to the Collaboration Products and the other products or activities
of such Party. Each Party shall disclose both the total costs incurred and the
apportionment in the information reported under Section 7.1.3(d) for review by
the other Party. At the request of the other Party, the Party making the
apportionment shall provide additional reasonable supporting documentation and
make its personnel reasonably available to answer questions. Any dispute
regarding such apportionment shall be a Financial Dispute.

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1.194    “Out-of-Pocket Costs” means costs and expenses paid to Third Parties
(or payable to Third Parties and accrued in accordance with the paying Party’s
Accounting Standards) by either Party or its Affiliates in connection with
activities under this Agreement, excluding FTE Costs and Expenses.
1.195    “Participating Party” means, at any time, the Party that is not the
Lead Party at such time.
1.196    “Party” and “Parties” has the meaning set forth in the preamble hereto.
1.197    “Patent Rights” means (a) all issued patents (including any extensions,
restorations by any existing or future extension or registration mechanism
(including patent term adjustments, patent term extensions, supplemental
protection certificates or the equivalent thereof), substitutions,
confirmations, re-registrations, re-examinations, and patents of addition); (b)
patent applications (including all provisional applications, substitutions,
requests for continuation, continuations, continuations-in-part, divisionals and
renewals); (c) inventor’s certificates; and (d) all equivalents of the foregoing
in any country of the world.
1.198    “Permitted Alnylam Outside Product” means [***].
1.199    [***]
1.200    “Permitted Claim Scope” means [***].
1.201    “Permitted Commercialization Overrun” has the meaning set forth in
Section 4.10.2.
1.202    “Permitted Competing Product” means any [(a) ]Competing Products
Directed to the Target pursuant to the exception to exclusivity set forth in
Section 6.7.1(a)(A)[, and (b)  Competing Products set forth on Schedule
1.202].11
1.203    “Permitted Development Overrun” has the meaning set forth in
Section 3.2.2(a).
1.204    “Permitted Dual Sequence” means [***].
1.205    “Permitted Dual Sequence Uses” means, with respect to any Permitted
Dual Sequence, [***], as applicable.
1.206    “Permitted Regeneron Outside Product” means [***].

11 Note to Draft: Include this bracketed language and this schedule only if the
Target was a CNS Target under the Master Agreement and there were Competing
Products Directed to the Target that were permitted with respect to the Target
pursuant to subsection (C) or (D) of Section 5.7.1(a) of the Master Agreement.
If included, the schedule should include the applicable exceptions.

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1.207    “Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, unincorporated association,
joint venture or other similar entity or organization, including a government or
political subdivision, department or agency of a government.
1.208    “Phase 1 Clinical Trial” means a human clinical trial of a
Collaboration Product, the principal purpose of which is a preliminary
determination of safety in healthy individuals or patients, or a similar
clinical study prescribed by the applicable Regulatory Authorities, pursuant to
Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §
312.21(a), as amended.
1.209    “Phase 1 Completion Date” means the date the Clinical Trial results
(e.g., key results memo) from the Phase 1 Clinical Trial conducted under the
Phase 1 Development Plan and Budget that are sufficient to support the
Initiation of a Phase 2 Clinical Trial for the first Collaboration Product are
made available to the JSC; provided that the foregoing shall not limit in any
way an Opt-Out Party’s obligations under Section 3.5.7.
1.210    “Phase 1 Development Plan and Budget” means, for Development activities
beginning immediately after acceptance by the applicable Regulatory Authority in
a Major Market Country (or the EMA pursuant to the centralized approval
procedure, or in any other country identified in the Pre-Clinical Plan and
Budget in which the Parties intend to file an IND for a Collaboration Product)
of the IND for the first Collaboration Product and continuing up to completion
of the Phase 1 Clinical Trial(s) for the first Collaboration Product, the
development plan setting forth in reasonable detail (a) the comprehensive plan
for the Development of the Collaboration Products in the Territory during such
period, including the applicable Development Phase Budget, and (b) the rolling
[***] plan of specific Development activities to be performed with respect to
the Collaboration Products and the anticipated timeline and Development Budget.
The Parties anticipate that Lead Party shall be primarily responsible for
conducting such Phase 1 Clinical Trials; provided that if Regeneron is the Lead
Party, Alnylam shall be responsible for the Alnylam Specific Activities set
forth in the Phase 1 Development Plan and Budget (as well as the Manufacture and
supply of Early Stage Supply Requirements). For clarity, the activities under
the Phase 1 Development Plan and Budget may continue even if the Phase 2
Development Plan and Budget has commenced. [***]

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1.211    “Phase 2 Clinical Trial” means a human clinical trial of a
Collaboration Product, the principal purpose of which is a determination of
safety and efficacy in the target patient population, or a similar clinical
study prescribed by the applicable Regulatory Authorities, pursuant to
Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §
312.21(b), as amended.
1.212    “Phase 2 Completion Date” means the date that the Clinical Trial
results (e.g., key results memo) from the Phase 2 Clinical Trial conducted under
the Phase 2 Development Plan and Budget that are sufficient to support the
Initiation of a Registration Enabling Trial for the first Collaboration Product
are made available to the JSC; provided that the foregoing shall not limit in
any way an Opt-Out Party’s obligations under Section 3.5.7.
1.213    “Phase 2 Development Plan and Budget” means, for Development activities
beginning immediately after the Phase 1 Completion Date and continuing up to the
completion of the Phase 2 Clinical Trial(s) for the first Collaboration Product,
the development plan setting forth in reasonable detail (a) the comprehensive
plan for the Development of the Collaboration Products in the Territory during
such period, including the applicable Development Phase Budget, and (b) the
rolling [***] plan of specific Development activities to be performed with
respect to the Collaboration Products and the anticipated timeline and
Development Budget, which plan shall allocate responsibility for such
Development activities between the Parties; provided, that the Parties
anticipate that the Lead Party shall be primarily responsible for all
Development activities set forth in the Phase 2 Development Plan and Budget;
provided that if Regeneron is the Lead Party, Alnylam shall be responsible for
the Alnylam Specific Activities set forth in the Phase 2 Development Plan and
Budget (as well as the Manufacture and supply of Early Stage Supply
Requirements). For clarity, the activities under the Phase 2 Development Plan
and Budget may continue even if the Late Stage Development Plan and Budget has
commenced. [***]
1.214    “Phase 3 Clinical Trial” means a human clinical trial of a
Collaboration Product on a sufficient number of subjects that is designed to
establish that a pharmaceutical product is safe and efficacious for its intended
use and to determine warnings, precautions, and adverse reactions that are
associated with such Collaboration Product in the dosage range to be prescribed,
which trial is intended to support Regulatory Approval of such Collaboration
Product, including all tests and studies that are required by the FDA, pursuant
to Applicable Law or otherwise.
1.215    “Post-Approval Development Budget” has the meaning set forth in
Section 3.1.7(b).
1.216    “Post-Termination Payments” has the meaning set forth in
Schedule 12.6(B).
1.217    “Pre-Clinical Plan and Budget” means, for Development activities to
support an IND filing (following lead candidate identification) for the first
Collaboration Product through the acceptance by the applicable Regulatory
Authority in a Major Market Country (or the EMA pursuant

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to the centralized approval procedure, or in any other country identified in the
Pre-Clinical Plan and Budget in which the Parties intend to file an IND for a
Collaboration Product) of the first IND for such Collaboration Product, the
development plan setting forth in reasonable detail (x) the comprehensive plan
for the Development of the Collaboration Products in the Territory during such
period, including the applicable Development Phase Budget, and (y) the rolling
[***] plan of specific Development activities to be performed with respect to
the Collaboration Products (including preclinical Development and Manufacturing
to support IND filings for the Collaboration Products) and the anticipated
timeline and Development Budget. Such plan shall allocate responsibility for
such Development activities primarily to the Lead Party; provided that if
Regeneron is the Lead Party, Alnylam shall be responsible for the Alnylam
Specific Activities set forth in the Pre-Clinical Plan and Budget (as well as
the Manufacture and supply of Early Stage Supply Requirements for such studies).
The initial Pre-Clinical Plan and Budget is expected to include any ongoing
Development activities under the Candidate Discovery Plan (as defined in the
Master Agreement) for the Target Program that have not been completed as of the
Effective Date (the “Ongoing Candidate Discovery Development Activities”);
provided that the Party that was allocated the applicable Ongoing Candidate
Discovery Development Activity under such Candidate Discovery Plan shall be
responsible for the continued performance of such activities under the
Pre-Clinical Plan and Budget. For clarity, the activities under the Pre-Clinical
Plan and Budget may continue even if the Phase 1 Development Plan and Budget has
commenced. In no event shall the Pre-Clinical Plan and Budget include any
activities for the general development of the Alnylam siRNA Platform.
1.218    “Pre-Existing Affiliates” has the meaning set forth in
Section 6.7.2(e).
1.219    “Pricing Approval” means such approval, agreement, determination or
governmental decision establishing prices for a Collaboration Product that can
be charged to consumers and will be reimbursed by Regulatory Authorities in
countries where Regulatory Authorities of such countries approve or determine
pricing for pharmaceutical products for reimbursement or otherwise.
1.220    “Product Labeling” means, with respect to a Collaboration Product in a
country in the Territory, (a) the Regulatory Authority approved full prescribing
information for such Collaboration Product for such country, including any
required patient information, and (b) all labels and other written, printed, or
graphic matter upon a container, wrapper, or any package insert utilized with or
for such Collaboration Product in such country.
1.221    “Product Regulatory Documentation” has the meaning set forth in
Section 9.1.
1.222    “Product-Related In-License” means a license or other similar agreement
with a Third Party (other than the Existing Alnylam In-Licenses and the Existing
Regeneron In-Licenses)

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to license or obtain any similar right or interest in any (a) Information
necessary or reasonably useful to perform any activities under a Development
Plan and Budget or to achieve the objectives thereof or to Exploit any
Collaboration Product or (b) Patent Right that Covers any Collaboration Product
or the Exploitation thereof.
1.223    “Product-Related IP” has the meaning set forth in Section 8.3.2.
1.224    “Product-Related Patents” has the meaning set forth in
Section 8.2.1(a).
1.225    “Product-Specific Factors” means [***].
1.226    “Product-Specific Information” has the meaning set forth in
Section 9.1.
1.227    “Product-Specific In-License” means a Product-Related In-License for
Information that is primarily related to, or Patent Rights that primarily claim,
Product-Specific Factors.
1.228    “Product Trademarks and Domain Names” means the Trademark(s) and any
domain names to be used by the Lead Party or its Affiliates or Sublicensees for
the Commercialization of Collaboration Products in the Territory and any
registrations thereof or any pending applications relating thereto in the
Territory (excluding, in any event, any trademarks, service marks, names or
logos that include any corporate name or logo of the Parties or their
Affiliates).
1.229    “Profit Payment Report” means the consolidated report prepared by the
Lead Party each Calendar Quarter (based on information reported under
Section 7.1.3) setting forth in reasonable detail, for each Major Market
Country, and in the aggregate, worldwide as a whole, (a) Net Sales, Cost of
Goods Sold, and Shared Commercial Expenses invoiced or incurred by each Party
for such Calendar Quarter, (b) Third Party Transaction Proceeds received by the
Lead Party for such Calendar Quarter, (c) Other Shared Expenses incurred by each
Party for such Calendar Quarter, and (d) the Quarterly Profit True-Up, and the
component items and calculations in determining such Quarterly Profit True-Up,
calculated in accordance with Schedule 7.1.1. If an item is included in one
Profit Payment Report, in no event shall the same item be included in a
subsequent Profit Payment Report.
1.230    “Profit Split” has the meaning set forth in Schedule 7.1.1.
1.231    “Profits” has the meaning set forth in Schedule 7.1.1.
1.232    “Promotional Materials” means, with respect to each Collaboration
Product and country in which such Collaboration Product is or will be sold,
promotional, advertising, communication and educational materials relating to
such Collaboration Product for use in connection with the marketing, promotion
and sale of such Collaboration Product in such country,

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and the content thereof, and shall include promotional literature, product
support materials and promotional giveaways.
1.233    [“Proof of Principle Criteria” means the criteria to be mutually agreed
to by the Parties prior to the commencement of the first Phase 1 Clinical Trial
for the Relevant Organ Product, as described in more detail in the Master
Agreement.
1.234    “Proof of Principle Study” means a Clinical Trial conducted under this
Agreement that is designed to meet the Proof of Principle Criteria and
identified by the Lead Party to the JSC pursuant to Section 3.1.10 hereof.]12 
1.235    “Proposal” has the meaning set forth in Schedule 1.
1.236    “Proprietary Unlicensed Component” means, with respect to a given
Party, an Unlicensed Component that is (a) proprietary to such Party (or its
Affiliate) or (b) otherwise controlled (through license or otherwise) by such
Party (or its Affiliate).
1.237    “Proprietary Unlicensed Component Non-Collaboration Development Costs”
means, [***].
1.238    “Quality Agreement” has the meaning set forth in Section 5.2.2.
1.239    “Quarterly Development True-Up” has the meaning set forth in
Schedule 7.1.1.
1.240    “Quarterly Profit True-Up” has the meaning set forth in Schedule 7.1.1.
1.241    “Recoupment Amount” means, with respect to a Party, subject to
Section 7.1.4(b) and Section 7.2.6(c), an amount equal to the sum of the
following: (a) [***] of the Excess Development Costs incurred by such Party in
the performance of any Development activities for Collaboration Products that
are necessary or reasonably useful to successfully achieve the objectives
contemplated by the applicable Development Plan and Budget, (b) [***] of the
Excess Commercialization Costs incurred by such Party and (c) [***] of the
Opt-Out Development Costs incurred by such Party; provided, that if a Party
exercises its Opt-Out Right, no Excess Development Costs or Excess
Commercialization Costs incurred by such Party after the corresponding Opt-Out
Date shall be included such Party’s Recoupment Amount.

12 Note to Draft: Definitions of Proof of Principle Criteria and Proof of
Principle Study will be included only if the Target is a CNS Target.

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1.242    “Recoupment Balance” means, with respect to a Party, subject to
Section 7.1.4(b) and Section 7.2.6(c), an amount equal to the Recoupment Amount
with respect to such Party less the sum of (a) any reductions in Quarterly
Profit True-Up payments by such Party pursuant to Section 7.1.4(a)(i), (b) any
increases in Quarterly Profit True-Up payments by the other Party pursuant to
Section 7.1.4(a)(ii), (c) any reductions in Royalty payments by such Party
pursuant to Section 7.2.6(a) and (d) any increases in Royalty payments by the
other Party pursuant to Section 7.2.6(b).
1.243    “Regeneron” has the meaning set forth in the preamble hereto.
1.244    “Regeneron Background Technology” means (a) Information that is
necessary or reasonably useful to Exploit any Collaboration Product and (b)
Patent Rights that Cover any Collaboration Product or the Exploitation of any
Collaboration Product, in each case, ((a) and (b)), that are Controlled by
Regeneron or its Affiliates during the Term, but excluding Regeneron
Collaboration IP and Regeneron’s interest in the Joint Collaboration IP. [***]
1.245    “Regeneron Background Technology Improvements” means any developments,
enhancements, modifications or other improvements to, or progeny, mutants,
fragments, or derivatives of, (x) the Regeneron Background Technology or [***],
that (a) are made by or on behalf of either Party or its Affiliates or its or
their Sublicensees under or in connection with this Agreement, and (b) with
respect to any of the foregoing constituting (i) Information, are not
specifically and solely related to any Product-Specific Factor and (ii) Patent
Rights, do not include any claim the practice of which necessarily requires the
presence or direct use of a Product-Specific Factor.
1.246    “Regeneron Collaboration IP” means (a) any improvement, discovery or
Information, patentable or otherwise, that is conceived or reduced to practice
(in whole or in part) or otherwise identified, discovered, made or developed, as
applicable, solely by individuals who are employees, agents or consultants of
Regeneron or its Affiliates or its or their Sublicensees, in each case, under or
in connection with this Agreement, and (b) any Patent Rights that Cover such
improvements, discoveries or Information described in clause (a). Regeneron
Collaboration IP excludes Regeneron’s interest in Joint Collaboration IP and any
Alnylam Background Technology Improvements. Patent Rights constituting Regeneron
Collaboration IP are either Regeneron Core Technology Patents or Regeneron
Product-Specific Patents, as the case may be.
1.247    “Regeneron Core Technology Know-How” means Regeneron Know-How other
than Regeneron Product-Specific Know-How.

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1.248    “Regeneron Core Technology Patents” means Regeneron Patents other than
Regeneron Product-Specific Patents.
1.249    “Regeneron In-License” means any (a) Existing Regeneron In-License,
(b) Product-Specific In-License between Regeneron (or its Affiliates) and a
Third Party entered into after the Effective Date but only to the extent that
such agreement is designated as a Regeneron In-License pursuant to
Section 6.5.1(a) or (c) Core Technology In-License between Regeneron (or its
Affiliates) and a Third Party entered into after the Effective Date but only to
the extent such agreement is designated as a Regeneron In-License pursuant to
Section 6.5.1(c) or Section 6.5.1(d). In the event that a given Product-Specific
In-License (as defined in the Master Agreement) or Core Technology In-License
(as defined in the Master Agreement) between Regeneron (or its Affiliates) and a
Third Party was designated to be a Regeneron In-License (as defined in the
Master Agreement) for the Target Program pursuant to the Master Agreement, then
such agreement shall also be a Regeneron-In License for this Agreement (as a
Product-Specific In-License or Core Technology In-License, as applicable, but
shall not be an Existing Regeneron In-License).
1.250    “Regeneron Indemnitees” has the meaning set forth in Section 11.1.1.
1.251    “Regeneron Internal Manufacturing Costs” has the meaning set forth in
the definition of “Minimum Internal Manufacturing Requirements”.
1.252    “Regeneron Know-How” means (a) the Information included in the
Regeneron Collaboration IP; (b) Regeneron’s interest in the Information included
in the Joint Collaboration IP; and (c) the Information included in any Regeneron
Background Technology or in any Regeneron Background Technology Improvements
that is not in the public domain or otherwise generally known.
1.253    “Regeneron Managed Patents” has the meaning set forth in Section
10.3.3.
1.254    “Regeneron Manufacturing Technology” means Regeneron Technology
relating to the Manufacturing Process of a Collaboration Product that is
Controlled by Regeneron or its Affiliates during the Term.
1.255    “Regeneron Mice” means Regeneron’s proprietary, genetically engineered
mice, and any progeny of such mice (including cross-bred progeny resulting from
producing a genetically engineered mouse by breeding or by using any portion of
any of Regeneron’s proprietary genetically engineered mice) or other mice
derived therefrom.
1.256    “Regeneron Patents” means (a) the Patent Rights included in the
Regeneron Collaboration IP; (b) Regeneron’s interest in the Joint Collaboration
Patents; and (c) the Patent

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Rights included in any Regeneron Background Technology or in any Regeneron
Background Technology Improvements.
1.257    “Regeneron Product-Specific Know-How” means Regeneron Know-How that is
specifically and solely related to Product-Specific Factors.
1.258    “Regeneron Product-Specific Patents” means the Regeneron Patents that
include at least one claim, the practice of which necessarily requires the
presence or direct use of a Product-Specific Factor, including those Patent
Rights set forth on Schedule 1.258.
1.259    “Regeneron Technology” means, collectively, Regeneron Know-How and
Regeneron Patents.
1.260    “Regeneron Termination Core Technology Know-How” means Regeneron
Termination Know-How other than Regeneron Termination Product-Specific Know-How.
1.261    “Regeneron Termination Core Technology Patents” means Regeneron
Termination Patents other than Regeneron Termination Product-Specific Patents.
1.262    “Regeneron Termination Know-How” means any Regeneron Know-How existing
as of the effective date of termination of this Agreement that (i) is not in the
public domain or otherwise generally known and (ii) is necessary or reasonably
useful to further Exploit a Terminated Product (A) as such Terminated Product
exists as of the effective date of termination of this Agreement or (B) based on
the Development Plan and Budget in effect as of the effective date of
termination of this Agreement.
1.263    “Regeneron Termination Patents” means (a) any Regeneron Patents
existing as of the effective date of termination of this Agreement that are
necessary or reasonably useful to Exploit a Terminated Product, (i) as such
Terminated Product exists as of the effective date of termination of this
Agreement or (ii) based on the Development Plan and Budget in effect as of the
effective date of termination of this Agreement, and (b) any Patent Rights that
claim priority to any Regeneron Patents in clause (a).
1.264    “Regeneron Termination Product-Specific Know-How” means Regeneron
Termination Know-How that is specifically and solely related to Product-Specific
Factors.
1.265    “Regeneron Termination Product-Specific Patents” means the Regeneron
Termination Patents that include at least one claim, the practice of which
necessarily requires the presence or direct use of a Product-Specific Factor.
1.266    “Registration Enabling Trial” means a human clinical trial (whether or
not designated a Phase 3 Clinical Trial) of a Collaboration Product (a) the
results of which, together

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with prior data and information concerning such Collaboration Product, are
intended at the time such human clinical trial is Initiated to establish that
such Collaboration Product is safe and effective for its intended use; and (b)
that forms the basis (alone or with one or more additional Registration Enabling
Trials) of an effectiveness claim in support of a Regulatory Approval for such
Collaboration Product, in each case ((a) and (b)), as acknowledged in writing by
the FDA for any human clinical trial that does not meet the criteria for a Phase
3 Clinical Trial at the time such human clinical trial is Initiated.
1.267    “Regulatory Approval” means, with respect to a country in the
Territory, any and all approvals (including Drug Approval Applications),
licenses, registrations, or authorizations of any Regulatory Authority necessary
to commercially distribute, sell, or market a Collaboration Product in such
country, including, where applicable, (a) Pricing Approval in such country, (b)
pre- and post-approval marketing authorizations (including any prerequisite
Manufacturing approval or authorization related thereto), and (c) labeling
approval.
1.268    “Regulatory Authority” means any applicable supra-national, federal,
national, regional, state, provincial, or local regulatory agencies,
departments, bureaus, commissions, councils, or other government entities
regulating or otherwise exercising authority with respect to the Exploitation of
a Collaboration Product in the Territory.
1.269    “Regulatory Documentation” means all (a) applications (including all
INDs and Drug Approval Applications and other Major Regulatory Filings),
registrations, licenses, authorizations, and approvals (including Regulatory
Approvals) and (b) correspondence and reports submitted to or received from
Regulatory Authorities (including minutes and official contact reports relating
to any communications with any Regulatory Authority) and all supporting
documents with respect thereto, including all regulatory drug lists, advertising
and promotion documents, adverse event files, and complaint files.
1.270    “Regulatory Exclusivity” means any exclusive marketing rights or data
exclusivity rights conferred by any Regulatory Authority with respect to a
Collaboration Product other than Patent Rights.
1.271    “Relevant Organ” means [________________]13.
1.272    “Relevant Organ Product” means any product containing siRNA that has
been specifically engineered or selected to be Directed to the Target as
expressed in the Relevant Organ; provided that such product shall still be a
“Relevant Organ Product” even if such product is also Directed to such Target as
expressed in another organ(s) in the body.  
13 Note to Draft: Insert the definition of “Liver” or “CNS” from the Master
Agreement, as applicable. In the event that “Eye” (as defined in the Master
Agreement) or any other organs are to be included in this Agreement pursuant to
Section 5.7.1(a)(C)(b) of the Master Agreement, then this Agreement will need to
be amended to include the Eye or such other organs, as applicable, as set forth
in Section 5.7.1(a)(C)(b) of the Master Agreement.

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1.273    “Requesting Party” has the meaning set forth in Section 3.3.
1.274    “Royalties” has the meaning set forth in Section 7.2.1.
1.275    “Royalty Term” means, with respect to a Collaboration Product and a
country, the period commencing on the date of the First Commercial Sale of such
Collaboration Product in such country and continuing until the latest of (a) the
expiration of the last Valid Claim in such country of an Alnylam Patent (other
than any Alnylam Core Technology Patent that is excluded for purposes of the
Royalty Term pursuant to Section 8.3.3), Joint Collaboration Patent or Regeneron
Patent (other than any Regeneron Core Technology Patent that is excluded for
purposes of the Royalty Term pursuant to Section 8.3.4) that Covers such
Collaboration Product, provided that the use or sale of such Collaboration
Product by the Lead Party (or its Affiliate or Sublicensee) in such country
infringes such Valid Claim in such country (notwithstanding any license or
ownership interest therein), (b) expiration of Regulatory Exclusivity for the
such Collaboration Product in such country and (c) the [***] anniversary of the
First Commercial Sale of such Collaboration Product in such country.
1.276    “Rules” has the meaning set forth in Schedule 1.
1.277    “Shared Claim” has the meaning set forth in Section 11.1.3.
1.278    “Shared Commercial Expenses” means the sum of the following items, in
each case to the extent directly attributable to Commercialization of
Collaboration Products worldwide in accordance with Commercialization Plan and
Budget, whether incurred prior to or after First Commercial Sale of a
Collaboration Product except as otherwise set forth in this Agreement, and to
the extent that such items do not include any costs included in Development
Costs:
1.278.1    Field Force Costs;
1.278.2    Out-of-Pocket Costs related to (a) the marketing, advertising or
promotion of Collaboration Products worldwide (including, pricing activities,
commercial pharmacovigilance, educational expenses, advocate development
programs and symposia and Promotional Materials for the Collaboration Product),
(b) market research for Collaboration Products worldwide and (c) the preparation
of training and communication materials for Collaboration Products worldwide;
1.278.3    Out-of-Pocket Costs related to [***] for Collaboration Products
worldwide, including the Out-of-Pocket Cost of clinical research organizations,
investigator and expert fees, lab fees and scientific service fees, the
Out-of-Pocket Cost of shipping clinical supplies

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to centers or disposal of clinical supplies, in each case, to the extent not
already included in the Cost of Goods Sold for such Collaboration Product;
1.278.4    Out-of-Pocket Costs related to [***] and the maintenance of all
Regulatory Approvals directly related to the Commercialization of Collaboration
Products;
1.278.5    Commercial Overhead Charge;
1.278.6    Out-of-Pocket Costs related to regulatory affairs activities, other
than activities to secure Regulatory Approval of indications and line
extensions;
1.278.7    any In-License Payments to the extent attributable to the
Commercialization of Collaboration Products (to the extent not otherwise
included in Development Costs);
1.278.8    Manufacturing Costs for Commercial Supply Requirements Manufactured
prior to the First Commercial Sale; and
1.278.9    any other costs or expenses directly related to the Commercialization
of a Collaboration Product and not included in clauses 1.278.1 through clauses
1.278.8 above and specifically identified and included in the Commercialization
Plan and Budget, or included as Shared Commercial Expenses under this Agreement.
If any of the foregoing costs benefit both Collaboration Product(s) and other
products or activities of a Party (for example, if an In-License is not
exclusively of benefit to Collaboration Products), then the applicable Party
incurring such costs shall apportion such costs in a manner that fairly and
reasonably reflects the benefit to the Collaboration Products and the other
products or activities of such Party. Each Party shall disclose both the total
costs incurred and the apportionment in the information reported under
Section 7.1.3(d) for review by the other Party. At the request of the other
Party, the Party making the apportionment shall provide additional reasonable
supporting documentation and make its personnel reasonably available to answer
questions. Any dispute regarding such apportionment shall be a Financial
Dispute. In no event shall the same costs be included more than once in Shared
Commercial Expenses under this Agreement, even if such costs are of benefit to
multiple Collaboration Products, provided that the applicable Collaboration
Products under or in connection with this Agreement benefitted by such Shared
Commercial Expenses may be taken into consideration with respect to such
apportionment.
1.279    “Shared Damages” has the meaning set forth in Section 11.1.3.
1.280    “Shared Facility” has the meaning set forth in Schedule 1.165.

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1.281    “siRNA” means an oligonucleotide composition of native or chemically
modified RNA that targets a gene through activation of the RNA interference
pathway, and that is not a MicroRNA, MicroRNA antagonist or MicroRNA Mimic.
1.282    “Sublicensed Party” has the meaning set forth in Section 6.5.4.
1.283    “Sublicensee” means a Third Party that is granted, in accordance with
this Agreement, a (sub)license by a Party or its Affiliates to intellectual
property licensed under this Agreement by such Party or its Affiliates to, or to
such Party and its Affiliates by, the other Party or its Affiliates, to Develop
or Commercialize a Collaboration Product.
1.284    “Sublicensor Party” has the meaning set forth in Section 6.5.4.
1.285    “Supply Agreement” has the meaning set forth in Section 5.2.2.
1.286    “Supply Price” has the meaning set forth in Section 5.2.2.
1.287    “Target” means the target identified on Schedule 1.287.14
1.288    “Term” has the meaning set forth in Section 12.1.
1.289    “Terminated Product” means any Collaboration Product that is the
subject of Development or Commercialization by or on behalf of the Lead Party in
the Territory as of the effective date of termination of this Agreement, but
excluding [***].
1.290    “Termination Transition Agreement” has the meaning set forth in
Schedule 12.6(B).
1.291    “Territory” means the entire world.
1.292    “Third Party” means any Person other than Alnylam, Regeneron and their
respective Affiliates.
1.293    “Third Party Acquisition” has the meaning set forth in
Section 6.7.2(a).
1.294    “Third Party Infringement Action” has the meaning set forth in
Section 8.6.1.
1.295    “Third Party Manufacturing Costs” has the meaning set forth in the
definition of “Minimum Internal Manufacturing Requirements”.

14 Note to Draft: Add the identity of the Target under this Agreement on
Schedule 1.285 at the time of execution of this Agreement.

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1.296    “Third Party Provider” has the meaning set forth in Section 3.1.9.
1.297    “Third Party Transaction” means any transaction pursuant to which the
Lead Party or its Affiliates grants a license, sells or otherwise grants or
transfers, including by option, to any Third Party (other than in connection
with (i) a Change of Control (provided, however that any such transaction shall
be considered a “Third Party Transaction” where, as of the consummation of such
transaction, the Collaboration Product(s) which are the subject matter of this
Agreement constitutes a majority of the assets of such Party) or (ii) a
subcontract as permitted pursuant to Section 3.1.9) rights in or to, including
any rights to further Develop or Commercialize, one or more Collaboration
Products.
1.298    “Third Party Transaction Proceeds” means, with respect to a Third Party
Transaction, any and all proceeds received by the Lead Party or any of its
Affiliates from Third Parties in respect of such Third Party Transaction,
including (a) upfront and milestone payments; (b) royalties, sales milestones,
profit share and other payments based on the sales of a Collaboration Product;
(c) the fair market value of any equity or debt securities issued in respect of
such Third Party Transaction to such Party or its Affiliates that exceeds any
amount paid by such Party or its Affiliates for such securities; (d) the amount
by which any amount paid by a Third Party to such Party or its Affiliates for
any equity or debt securities issued to such Third Party in respect of such
Third Party Transaction exceeds the fair market value of such securities; (e)
the amount by which the transfer price for any Collaboration Product paid by a
Third Party to such Party or its Affiliates exceeds the actual Manufacturing
Costs for such Collaboration Product; (f) the fair market value of any other
form of consideration paid to, or received by or otherwise recognized by such
Party or its Affiliates by or from a Third Party in connection with such Third
Party Transaction as reasonably agreed by the Parties; but excluding any amounts
received by the Lead Party or any of its Affiliates at any time after a Party
exercises its Opt-Out Right, as (i) reimbursement for research and development
costs that were actually incurred by a Party for the Development of the
Collaboration Product(s) that are the subject of the Third Party Transaction
(the Participating Party’s share of such amounts (if any) for Development Costs
shared by the Parties pursuant to Section 7.1.1 or Section 3.5.7(e) is addressed
in Section 7.2.9(a)), or (ii) bona fide pre-payment of research and development
costs incurred by the Lead Party after a Party exercised its Opt-Out Right, for
the Development of the Collaboration Product(s) that are the subject of the
Third Party Transaction. If a Third Party Transaction includes products or
intellectual property other than Collaboration Products or intellectual property
claiming or Covering Collaboration Products, the Parties shall mutually agree
upon a fair and reasonable allocation of the Third Party Transaction Proceeds.
Any dispute regarding (x) the fair market value of any equity or debt securities
issued in respect of a Third Party Transaction, (y) the fair market value of any
other form of consideration paid to, or received by or otherwise recognized by a
Party or its Affiliates by or from a Third Party in connection

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with a Third Party Transaction or (z) the allocation of Third Party Transaction
Proceeds between the Collaboration Products and other products or intellectual
property included in the applicable Third Party Transaction, in each case ((x)
through (z)), shall be a Financial Dispute.
1.299    “Third Party Transaction Proceeds Percentage” means, (a) if a Party
exercises its Opt-Out Right prior to the Phase 2 Completion Date, [***] and (b)
if a Party exercises its Opt-Out Right on or after the Phase 2 Completion Date,
[***]; provided, that if the Third Party Transaction Proceeds result from a
Third Party Transaction entered into by the then current Lead Party [***] after
a Party exercised its Opt-Out Right, pursuant to which the Third Party assumed
all further development funding obligations for the Collaboration Products, then
clause (a) shall be deemed to be [***] and clause (b) shall be deemed to be
[***]; provided, further, that if the Third Party Transaction Proceeds result
from a Third Party Transaction entered into prior to the Opt-Out Date pursuant
to which the Third Party assumed all further development funding obligations for
the applicable Collaboration Products in the applicable parts of the Territory,
then the Third Party Transaction Proceeds Percentage will be [***], even if the
Third Party Transaction Proceeds are received by the Lead Party on or after the
Opt-Out Date.
1.300    “Total Development Costs” has the meaning set forth in Schedule 7.1.1.
1.301    “Trademark” means any word, name, symbol, color, designation or device
or any combination thereof that functions as a source identifier, including any
trademark, trade dress, brand mark, service mark, trade name, brand name, logo
or business symbol, whether or not registered.
1.302    “United States” or “U.S.” means the United States of America and its
territories and possessions (including the District of Columbia and Puerto
Rico).
1.303    “Unlicensed Component” means (a) any API of a Combination Product that
is not an siRNA Directed to the Target or (b) any API that is otherwise
administered in a Clinical Trial of a Collaboration Product (in accordance with
the protocol for such Clinical Trial) that is not an siRNA Directed to the
Target.
1.304    “Valid Claim” means a claim of (a) any issued and unexpired Patent
Right whose validity, enforceability, or patentability has not been affected by
any of the following: (i) irretrievable lapse, abandonment, revocation,
dedication to the public, or disclaimer; or (ii) a holding, finding, or decision
of invalidity, unenforceability, or non-patentability by a court, governmental
agency, national or regional patent office, or other appropriate body that has
competent jurisdiction, such holding, finding, or decision being final and
unappealable or unappealed within the time allowed for appeal, or (b) a patent
application prosecuted in good faith that has been pending less than [***] years
from the date of filing of the earliest patent application to which such patent
application claims priority, which claim has not been cancelled, withdrawn or
abandoned, or finally rejected by an administrative agency action from which no
appeal can be taken.

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ARTICLE 2    
COLLABORATION MANAGEMENT
2.1    Joint Steering Committee.
2.1.1    Formation. Within fifteen (15) days after the Effective Date, the
Parties shall establish a joint steering committee (the “Joint Steering
Committee” or “JSC”). The JSC shall consist of three (3) representatives from
each of the Parties, each with the requisite experience and seniority to enable
such person to make decisions on behalf of the Parties with respect to the
issues falling within the jurisdiction of the JSC; provided that the Parties may
agree to increase or decrease the number of equal representatives from each
Party. From time to time, each Party may replace one or more of its
representatives to the JSC on written notice to the other Party. Each Party
shall appoint one of its representatives to serve as a co-chairperson of the
JSC, and a Party may change its appointed co-chairperson from time to time upon
written notice to the other Party.
2.1.2    Specific Responsibilities. The JSC shall oversee the Development,
Commercialization, Manufacture and other Exploitation of the Collaboration
Products in the Territory. In particular, the JSC shall:
(a)    review, discuss and coordinate the Parties’ activities under this
Agreement, including oversight of the JDC, the JCC, the JMC and the JFC,
including resolving any disputes that arise in the JDC, the JCC, the JMC or the
JFC;
(b)    select the Collaboration Products to advance into Clinical Trials;
(c)    review, discuss and approve the initial Pre-Clinical Plan and Budget, the
initial Phase 1 Development Plan and Budget, the initial Phase 2 Development
Plan and Budget and the initial Late Stage Development Plan and Budget, in each
case that has been submitted by the JDC;
(d)    review and discuss whether a targeting ligand or other delivery
technology is a Non-Relevant Organ Delivery Technology;
(e)    review, discuss and approve any updates or material amendments to any
Development Plan and Budget that have been submitted by the JDC;
(f)    determine the Anticipated IND Submission Date;
(g)    review, discuss and approve the Manufacturing Plan and any amendments and
updates to the Manufacturing Plan that have been submitted by the JMC;

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(h)    review, discuss and approve the initial Commercialization Plan and Budget
and any material amendments thereto that have been submitted by the JCC;
(i)    discuss any decision with respect to a Collaboration Product that either
Party reasonably anticipates would give rise to a material obligation to a Third
Party, including by requiring entry into an In-License with such Third Party;
(j)    review, discuss and approve the material terms of any Third Party
Transaction and the grant of any other sublicenses by a Party pursuant to
Section 6.3 to Develop or Commercialize a Collaboration Product;
(k)    review and approve Field Force FTE Rates and any updates thereto;
(l)    determine the Anticipated FCS Date for each applicable Collaboration
Product and country and the anticipated filing date for the respective Drug
Approval Application in each such country;
(m)    review, discuss and approve entering into any Product-Specific
In-Licenses and discuss potential Core Technology In-Licenses, in each case,
pursuant to Section 6.5.1;
(n)    discuss whether to accept a Core Technology In-License as an In-License;
(o)    [***];
(p)    [***];
(q)    review, discuss and approve, with respect to Manufacturing Costs for
Commercial Supply Requirements that are Manufactured directly by a Party or its
Affiliate in such Party’s or such Affiliate’s facility (and not via a Third
Party contract manufacturer), adjustments to standard costs in accordance with
Schedule 1.165, including with respect to extraordinary occurrences, as jointly
proposed by the JMC and JFC; and
(r)    perform 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.
2.2    Joint Development Committee.
2.2.1    Formation. Within thirty (30) days after the Effective Date, or as
otherwise agreed by the Parties, the Parties shall establish a joint development
committee (the “Joint Development Committee” or “JDC”). The JDC shall consist of
three (3) representatives from each of the Parties, each with the requisite
experience and seniority to enable such person to make

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decisions on behalf of the Parties with respect to the issues falling within the
jurisdiction of the JDC; provided that the Parties may agree to increase or
decrease the number of equal representatives from each Party. From time to time,
each Party may replace one or more of its representatives to the JDC on written
notice to the other Party. Each Party shall appoint one of its representatives
to serve as a co-chairperson of the JDC, and a Party may change its appointed
co-chairperson from time to time upon written notice to the other Party.
2.2.2    Specific Responsibilities. The JDC shall develop the strategies for and
oversee the Development of the Collaboration Products in the Territory, and
shall serve as a forum for the coordination of Development activities for the
Collaboration Products for the Territory. In particular, the JDC shall:
(a)    review and discuss the initial Pre-Clinical Plan and Budget, the initial
Phase 1 Development Plan and Budget, the initial Phase 2 Development Plan and
Budget and the initial Late Stage Development Plan and Budget, submitted to it
by the Lead Party, and in each case, submit such Development Plan and Budget for
approval by the JSC;
(b)    review and discuss any updates or material amendments to any Development
Plan and Budget submitted by either Party, and submit such update or material
amendment for approval by the JSC;
(c)    serve as a forum for discussing the Development activities under each
Development Plan and Budget, including any potential Development activities for
Collaboration Products for inclusion in a Development Plan and Budget (including
new indications);
(d)    serve as a forum for discussing strategies for obtaining Regulatory
Approvals for the Collaboration Products in the Territory; and
(e)    perform 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.
2.3    Joint Commercialization Committee.
2.3.1    Formation. The Parties shall establish a joint commercialization
committee (the “Joint Commercialization Committee” or “JCC”) at least [***]
months prior to the first Anticipated FCS Date in the Territory. The JCC shall
consist of three (3) representatives from each of the Parties, each with the
requisite experience and seniority to enable such person to make decisions on
behalf of the Parties with respect to the issues falling within the jurisdiction
of the JCC; provided that the Parties may agree to increase or decrease the
number of equal representatives from each Party. From time to time, each Party
may replace one or more of its representatives to the JCC on written notice to
the other Party. Each Party shall appoint one of its representatives to

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serve as a co-chairperson of the JCC, and a Party may change its appointed
co-chairperson from time to time upon written notice to the other Party.
2.3.2    Specific Responsibilities. The JCC shall develop the strategies and
activities for and oversee the Commercialization of the Collaboration Products
in the Territory. In particular, the JCC shall:
(a)    review and discuss the initial Commercialization Plan and Budget and
submit such Commercialization Plan and Budget for approval by the JSC;
(b)    review and discuss any updates or material amendments to the
Commercialization Plan and Budget, and submit such update or material amendment
for approval by the JSC;
(c)    serve as a forum for discussing all Commercialization strategy and the
Commercialization activities under the Commercialization Plan and Budget; and
(d)    perform 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.
2.4    Joint Finance Committee.
2.4.1    Formation. Within thirty (30) days after the Effective Date, the
Parties shall establish a joint finance committee (the “Joint Finance Committee”
or “JFC”). The JFC shall consist of three (3) representatives from each of the
Parties, each with the requisite experience and seniority to enable such person
to make decisions on behalf of the Parties with respect to the issues falling
within the jurisdiction of the JFC; provided that the Parties may agree to
increase or decrease the number of equal representatives from each Party. From
time to time, each Party may replace one or more of its representatives to the
JFC on written notice to the other Party. Each Party shall appoint one of its
representatives to serve as a co-chairperson of the JFC, and a Party may change
its appointed co-chairperson from time to time upon written notice to the other
Party.
2.4.2    Specific Responsibilities. The JFC shall:
(a)    be responsible for accounting, financial (including planning, reporting
and controls) and funds flow matters related to this Agreement, including such
specific responsibilities set forth in ARTICLE 7;
(b)    respond to financial related inquiries from the JSC, JDC, the JMC and the
JCC, as needed;

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(c)    discuss, following a request by a Party pursuant to Section 3.1.7(a),
Section 3.1.7(b) or Section 4.2.2, the appropriate level of detail to include in
a Development Budget, Post-Approval Development Budget or Commercialization
Budget, as the case may be, for the applicable activities to be performed during
the period covered by such Development Budget, Post-Approval Development Budget
or Commercialization Budget;
(d)    [***];
(e)    review, discuss and propose to the JSC operating principles consistent
with Accounting Standards for calculating Manufacturing Costs as set forth in
Schedule 1.165; and
(f)    perform 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.
2.5    Joint Manufacturing Committee.
2.5.1    Formation. Within thirty (30) days after the Effective Date, or as
otherwise agreed by the Parties, the Parties shall establish a joint
manufacturing committee (the “Joint Manufacturing Committee” or “JMC”). The JMC
shall consist of three (3) representatives from each of the Parties, each with
the requisite experience and seniority to enable such person to make decisions
on behalf of the Parties with respect to the issues falling within the
jurisdiction of the JMC; provided that the Parties may agree to increase or
decrease the number of equal representatives from each Party. From time to time,
each Party may replace one or more of its representatives to the JMC on written
notice to the other Party. Each Party shall appoint one of its representatives
to serve as a co-chairperson of the JMC, and a Party may change its appointed
co-chairperson from time to time upon written notice to the other Party. The JMC
shall establish a manufacturing working group to interact on a monthly basis (or
more frequent basis as mutually agreed to by the Parties) in order to closely
communicate and coordinate Manufacturing activities hereunder.
2.5.2    Specific Responsibilities. The JMC shall:
(a)    work with the JSC, JDC and JCC, as appropriate, to be responsible for
overseeing Manufacturing activities;
(b)    develop the Manufacturing Plan, including to the extent appropriate, for
a second source manufacturer for Collaboration Products, for approval by the JSC
and amend and update the Manufacturing Plan as necessary for approval by the
JSC;
(c)    discuss raw material quantities and ordering lead times sufficient to
meet the Early Stage Supply Requirements and the Late Stage Development Supply
Requirements for Collaboration Products;

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(d)    review operational issues and quality control data relating to the
Manufacture or supply of the Collaboration Products and any related devices;
(e)    make recommendations to the JSC regarding capacity planning, supply plans
and supply continuity planning for each Collaboration Product for consistency
with the forecasts, including consultation with the JDC regarding clinical
supply Manufacturing;
(f)    review and discuss actual Manufacturing Costs, Clinical Supply Costs,
Development Costs (with respect to Manufacturing) and Cost of Goods Sold versus
the applicable budget with respect thereto, including key variance drivers, on a
quarterly basis;
(g)    review, discuss and propose to the JSC whether and to what extent [***];
(h)    review, discuss and propose to the JSC whether and to what extent [***];
(i)    coordinate and discuss the Manufacture and supply of Collaboration
Product hereunder and the manufacture and supply of Collaboration Products (as
defined in the applicable Co-Co Collaboration Agreement or License Agreement)
under other Co-Co Collaboration Agreements or License Agreements;
(j)    [***] the JMC shall review and discuss [***];
(k)    review, discuss with the JFC and propose jointly with the JFC to the JSC
[***]
(l)    perform 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.
2.6    General Provisions Applicable to Joint Committees.
2.6.1    Meetings. Each Joint Committee shall hold meetings at such times as the
Parties shall determine, but in no event less frequently than (a) once each
Calendar Quarter during the Term, with respect to the JSC, and (b) once each
Calendar Quarter during the Term or as otherwise agreed by the Parties, with
respect to all other Joint Committees, in each case ((a) and (b)), commencing
from and after the time such Joint Committee is established as provided herein
unless the co-chairpersons agree otherwise. All Joint Committee meetings may be
conducted by telephone, video-conference or in person as determined by mutual
agreement of the co-chairpersons; provided, that each Joint Committee shall meet
in person at least twice each Calendar Year, unless otherwise agreed by the
Parties. Unless otherwise agreed by the Parties, all in-person meetings of a
Joint Committee shall be held on an alternating basis between Regeneron’s
facilities and Alnylam’s

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facilities. A reasonable number of other representatives of a Party may attend
any Joint Committee meeting as non-voting observers (provided, that such
additional representatives are under obligations of confidentiality and non-use
applicable to the Confidential Information of the other Party that are at least
as stringent as those set forth in ARTICLE 9). Each Party shall be responsible
for all of its own expenses of participating in each Joint Committee. Either
Party’s representatives on a Joint Committee may call a special meeting of the
applicable Joint Committee upon at least five (5) Business Days’ prior written
notice, except that emergency meetings may be called with at least two (2)
Business Days’ prior written notice.
2.6.2    Procedural Rules. Each Joint Committee shall have the right to adopt
such standing rules as shall be necessary for its work, to the extent that such
rules are not inconsistent with this Agreement. A quorum of the Joint Committee
shall exist whenever there is present at a meeting at least one (1)
representative appointed by each Party. Each Joint Committee shall take action
by consensus of the representatives present at a meeting at which a quorum
exists, with each Party having a single vote irrespective of the number of
representatives of such Party in attendance, or by a written resolution signed
by at least one (1) representative appointed by each Party.
2.6.3    Dispute Resolution.
(a)    Joint Committee (other than the JSC) Disputes. In the event there is a
dispute at the level of the JDC, JCC, JFC or JMC, the Parties, through such
Joint Committee, shall seek to resolve the dispute as promptly as possible, but
no later than ten (10) days after a Party has delivered to the other Party a
written request to resolve the matter, and in the event that no resolution is
reached at the JDC, JCC, JFC or JMC, as applicable, such matter shall be
promptly referred to the JSC for resolution.
(b)    JSC Disputes. If the JSC, after a period of thirty (30) days from the
date a matter is submitted to it for decision (including if the JSC is unable to
agree on any Development Plan and Budget or the Commercialization Plan and
Budget, or amendment thereto), is unable to make a decision due to a lack of
required unanimity, either Party may require that the dispute be submitted to
the Executive Officers for resolution by providing written notice to the other
Party formally requesting that the dispute be resolved by the Executive Officers
and specifying the nature of the dispute. If a dispute is referred to the
Executive Officers, then the Executive Officers shall diligently and in good
faith attempt to resolve the referred dispute within fifteen (15) days after
receiving written notification of such dispute or such longer period of time as
the Executive Officers may agree in writing. Any final decision mutually agreed
to by the Executive Officers with respect to a dispute and set forth in writing
shall be conclusive and binding on the Parties. If the Executive Officers cannot
resolve such dispute within such fifteen (15) days or such other period as
agreed by the Executive Officers, such dispute will be resolved as follows:

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(i)    for any JSC Dispute other than a [***] provided that any final
determination permitted to be made by the Lead Party under this
Section 2.6.3(b)(i) shall: [***];
(ii)    if the dispute is related to: (A) entering into (or the material terms
of) any proposed [***] with respect to rights in or to (including any rights to
further Develop or Commercialize) one or more Collaboration Products in the
[***]; [***] (each of (A) through (D), a “Deadlocked Dispute”), neither Party
shall have the right to resolve such Deadlocked Dispute and such Deadlocked
Dispute shall remain deadlocked until resolved by mutual agreement of the
Parties;
(iii)    if the dispute is related to a Financial Dispute or a Legal Dispute,
such dispute shall be resolved pursuant to Section 13.5; and
(iv)    [***]
(v)    if the dispute is related to (A) whether a given activity is an Alnylam
Specific Activity (B) whether a targeting ligand or other delivery technology
proposed under Section 3.1.12 is a type of Non-Relevant Organ Delivery
Technology or [***] (each of clauses (A), (B) and (C), an “Expert Dispute”), the
Parties will mutually agree on an Expert and will submit such matter for
resolution by such Expert in accordance with Schedule 2, and the determination
of the Expert will be binding on the Parties. For avoidance of doubt, the
Parties shall be bound by the determination of such Expert and the JSC shall
have no authority to modify or amend the finding of the Expert; or
(vi)    [***]
2.6.4    Limitations on Authority. Each Party shall retain the rights, powers,
and discretion granted to it under this Agreement and no such rights, powers, or
discretion shall be delegated to or vested in a Joint Committee unless such
delegation or vesting of rights is expressly provided for in this Agreement or
the Parties expressly so agree in writing. No Joint Committee shall have the
power to amend, modify, or waive compliance with this Agreement, which may only
be amended or modified as provided in Section 13.7 or compliance with which may
only be waived as provided in Section 13.10. For clarity, the JSC shall serve as
a discussion forum only for Core Technology In-Licenses, and the JSC shall not
have any decision-making authority with respect thereto (and for clarity, each
Party shall have decision-making authority with respect to its respective Core
Technology In-Licenses).
2.7    Committees under the Master Agreement and other Co-Co Collaboration
Agreements and License Agreements. If agreed to by the Parties, a particular
Joint Committee hereunder can be the same as the equivalent committee under the
Master Agreement or any other Co-Co Collaboration Agreement or License Agreement
(e.g., the JSC hereunder can be the same

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committee as the JSC under the Master Agreement or any other Co-Co Collaboration
Agreement or License Agreement).
2.8    Sub-Committees and Working Groups. Each Joint Committee may establish
sub-committees or working groups to interact on a more frequent basis on
specific projects and tasks assigned to them by such Joint Committee; provided,
that the authority of such sub-committees or working groups shall not expand
beyond the authority of the applicable Joint Committee. Any such sub-committees
or working groups shall have no decision-making authority, but shall make
recommendations to the applicable Joint Committee for its review and approval.
2.9    Discontinuation of Participation on a Committee. Each Joint Committee
shall continue to exist until the first to occur of: (a) the Parties mutually
agreeing to disband the Joint Committee; and (b) a Party exercising its Opt-Out
Right. Once a Party exercises its Opt-Out Right or if the Parties mutually agree
to disband the JSC, all Joint Committees shall be immediately disbanded and
shall have no further rights or obligations under this Agreement, and the Lead
Party shall, except as otherwise provided in this Agreement, have the right to
solely decide, without consultation with the Participating Party, all matters
that are subject to the review or approval by such Joint Committee hereunder
other than a Financial Dispute, Legal Dispute or Expert Dispute, which shall be
resolved pursuant to Section 13.5.
2.10    Alliance Manager. Each Party shall appoint a senior representative who
possesses a general understanding of this Agreement and pharmaceutical research,
clinical, regulatory, manufacturing and commercialization matters and who shall
oversee contact between the Parties for all matters between meetings of each
Joint Committee and shall have such other responsibilities as the Parties may
agree in writing after the Effective Date (each, an “Alliance Manager”) for so
long as neither Party has exercised its Opt-Out Right. Each Party may replace
its Alliance Manager at any time by notice in writing to the other Party.
ARTICLE 3    
DEVELOPMENT AND REGULATORY
3.1    Development Activities.
3.1.1    Transition of Development Activities from Master Agreement. To the
extent that the Participating Party was performing Development activities with
respect to the Target Program under the Master Agreement, the Participating
Party shall use Commercially Reasonable Efforts to provide cooperation and
assistance to the Lead Party, as reasonably requested by the Lead Party, to
enable the Lead Party to assume the continuation of such Development of the
Collaboration Products in the Territory pursuant to this Agreement; provided,
however, that (a) the Participating Party shall not transition to the Lead Party
any Ongoing Candidate Discovery Development Activities that are allocated to the
Participating Party (as set forth in the Pre-Clinical Plan and

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Budget) and (b) if Regeneron is the Lead Party, Alnylam shall not transition to
Regeneron any Alnylam Specific Activities. Such cooperation and assistance shall
be provided in a prompt and timely manner.
3.1.2    Pre-Clinical Activities.
(a)    Within thirty (30) days after the Effective Date the JSC shall review,
revise and approve the proposed initial Pre-Clinical Plan and Budget (which
shall be based on the Preliminary Pre-Clinical Plan (as defined in the Master
Agreement) provided under the Master Agreement for the Target Program);
provided, that the Pre-Clinical Plan and Budget shall not become effective
unless and until approved by the JSC (or the Executive Officers pursuant to
Section 2.6.3(b) or [***]). Pending such time as the JSC (or the Executive
Officers pursuant to Section 2.6.3(b) or the Lead Party pursuant to
Section 2.6.3(b)(i)) approves the initial Pre-Clinical Plan and Budget
(including during the period while the Parties are in the process of entering
into this Agreement in accordance with Article 4 of the Master Agreement), the
Lead Party may commence Development activities as set forth in, and in
accordance with, the Preliminary Pre-Clinical Plan and Budget (as defined in the
Master Agreement) for the Target Program, and such activities will be deemed to
be performed under the Pre-Clinical Plan and Budget once the initial
Pre-Clinical Plan and Budget is so approved.
(b)    Each Party shall use Commercially Reasonable Efforts to (i) perform the
Development activities assigned to it under the Pre-Clinical Plan and Budget in
accordance with the timeline and budget set forth therein and (ii) achieve the
goals and objectives set forth in the Pre-Clinical Plan and Budget.
(c)    In the event that either Party reasonably believes that [***].
3.1.3    Phase 1 Development Activities.
(a)    At least one hundred twenty (120) days prior to the anticipated date of
IND submission to the FDA for the first Collaboration Product, as such date is
reasonably determined by the JSC (or the Executive Officers pursuant to
Section 2.6.3(b) or the Lead Party pursuant to Section 2.6.3(b)(i)) (the
“Anticipated IND Submission Date”), the Lead Party, in consultation with the
Participating Party, shall provide the JDC with a proposed initial Phase 1
Development Plan and Budget for the JDC’s review, discussion and potential
modification prior to submission of the initial Phase 1 Development Plan and
Budget by the JDC to the JSC for review and approval. Based on its review of the
Parties’ proposed initial Phase 1 Development Plan and Budget and within thirty
(30) days after receipt of such proposal, the JDC shall propose to the JSC an
initial Phase 1 Development Plan and Budget. The JSC shall endeavor to approve
the Phase 1 Development Plan and Budget within sixty (60) days after receipt of
the proposed initial Phase 1 Development Plan and Budget by the JDC, and in no
event later than the screening of the first

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subject for the first Phase 1 Clinical Trial for a Collaboration Product;
provided, that the Phase 1 Development Plan and Budget shall not become
effective unless and until approved by the JSC (or the Executive Officers
pursuant to Section 2.6.3(b) or the Lead Party pursuant to Section 2.6.3(b)(i)).
(b)    Each Party shall use Commercially Reasonable Efforts to (i) perform the
Development activities assigned to it under the Phase 1 Development Plan and
Budget in accordance with the timeline and budget set forth therein and (ii)
achieve the goals and objectives set forth in the Phase 1 Development Plan and
Budget.
3.1.4    Phase 2 Development Activities.
(a)    Within sixty (60) days after the Phase 1 Completion Date, the Lead Party,
in consultation with the Participating Party, shall provide the JDC with a
proposed initial Phase 2 Development Plan and Budget for the JDC’s review,
discussion and potential modification prior to submission of the initial Phase 2
Development Plan and Budget by the JDC to the JSC for review and approval. Based
on its review of the Parties’ proposed initial Phase 2 Development Plan and
Budget and within thirty (30) days after receipt of such proposal, the JDC shall
propose to the JSC an initial Phase 2 Development Plan and Budget. The JSC shall
endeavor to approve the Phase 2 Development Plan and Budget within sixty (60)
days after receipt of the proposed initial Phase 2 Development Plan and Budget
by the JDC, and in no event later than the screening of the first patient for
the first Phase 2 Clinical Trial for a Collaboration Product; provided, that the
Phase 2 Development Plan and Budget shall not become effective unless and until
approved by the JSC (or the Executive Officers pursuant to Section 2.6.3(b) or
the Lead Party pursuant to Section 2.6.3(b)(i)).
(b)    Each Party shall use Commercially Reasonable Efforts to (i) perform the
Development activities assigned to it under the Phase 2 Development Plan and
Budget in accordance with the timeline and budget set forth therein and (ii)
achieve the goals and objectives set forth in the Phase 2 Development Plan and
Budget.
3.1.5    Phase 3 Development Activities.
(a)    Within sixty (60) days after the Phase 2 Completion Date, the Lead Party,
in consultation with the Participating Party, shall provide the JDC with a
proposed initial Late Stage Development Plan and Budget for the JDC’s review,
discussion and potential modification prior to submission of the initial Late
Stage Development Plan and Budget by the JDC to the JSC for review and approval.
Based on its review of the Parties’ proposed initial Late Stage Development Plan
and Budget and within thirty (30) days after receipt of such proposal, the JDC
shall propose to the JSC an initial Late Stage Development Plan and Budget. The
JSC shall endeavor to approve the Late Stage Development Plan and Budget within
sixty (60) days after receipt of the

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proposed initial Late Stage Development Plan and Budget by the JDC; provided,
that the Late Stage Development Plan and Budget shall not become effective
unless and until approved by the JSC (or the Executive Officers pursuant to
Section 2.6.3(b) or the Lead Party pursuant to Section 2.6.3(b)(i)).
(b)    Each Party shall use Commercially Reasonable Efforts to (A) perform the
Development activities assigned to it under the Late Stage Development Plan and
Budget in accordance with the timeline and budget set forth therein and (B)
achieve the goals and objectives set forth in the Late Stage Development Plan
and Budget; and the Lead Party shall use Commercially Reasonable Efforts to
obtain Regulatory Approval of a Collaboration Product in each of the Major
Market Countries.
3.1.6    Operational Discretion. Subject to the terms and conditions of this
Agreement, including Sections 3.1.9 and 6.3, the Party to which an activity
under any Development Plan and Budget is assigned shall have the right to make
operational decisions with respect to how such activity is conducted from an
operational perspective; provided that (a) such decisions are consistent with
this Agreement and the Development Plan and Budget and (b) such decisions are
consistent with customary business practices for other of its similar products.
3.1.7    Development Budgets.
(a)    Development Budgets. Until the First Commercial Sale of a Collaboration
Product in the first Major Market Country, each Development Plan and Budget will
contain (i) a three (3)-Calendar Year rolling budget for the probable
Development Costs for the Development activities to be performed during the
then-current Calendar Year (broken down by Calendar Quarter) and the next two
(2) Calendar Years (broken down by Calendar Year) of such Development Plan and
Budget; provided that (A) if six (6) months or more remain in the then-current
Calendar Year commencing as of the date of such initial Development Plan and
Budget and ending December 31 of such Calendar Year, such partial year shall
constitute a full Calendar Year for purposes of this Section 3.1.7(a), and such
initial Development Plan and Budget shall include such a budget for such partial
year and two (2) Calendar Years thereafter (broken down by Calendar Quarter for
the first full Calendar Year and the stub period) and (B) if less than six (6)
months remain in the then-current Calendar Year commencing as of the date of
such initial Development Plan and Budget and ending December 31 of such Calendar
Year, such initial Development Plan and Budget shall include such a budget for
such partial Calendar Year and for three (3) Calendar Years thereafter (broken
down by Calendar Quarter for the first full Calendar Year and the stub period)
(each such budget, a “Development Budget”) and (ii) the Development Phase Budget
with respect to such Development Plan and Budget; provided that, unless
otherwise amended pursuant to Section 3.1.8, such Development Phase Budget shall
be the Development Phase Budget set forth in the applicable initial Development
Plan and Budget. The first full Calendar Year plus any such partial Calendar

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Year, if applicable, of the then-current Development Budget shall be binding,
and the second and third full Calendar Years of the Development Budget shall be
non-binding. The initial Development Budget and initial Development Phase Budget
for each Development Plan and Budget, and each update thereto, will be prepared
by the Parties based on each Party’s good faith estimation, consistent with its
standard internal practices, of the probable Development activities to be
conducted during the relevant Development Budget period or Development Phase
Budget Period, and based on and consistent with the documents and information
related to the Collaboration Products prepared by such Party for its internal
use and reference in the budgeting process. Upon request by a Party, the JFC
shall discuss the appropriate level of detail to include in a Development Budget
for the applicable Development activities to be performed during the period
covered by such Development Budget.
(b)    Post-Approval Development Budgets. Commencing with the First Commercial
Sale of a Collaboration Product in a Major Market Country, the Late Stage
Development Plan and Budget will contain a three (3)-Calendar Year rolling
budget for the probable Development Costs for the Development activities to be
performed during the then-current Calendar Year (broken down by Calendar
Quarter) and the next two (2) Calendar Years (broken down by Calendar Year);
provided that (i) if six (6) months or more remain in the then-current Calendar
Year commencing as of the date of such Late Stage Development Plan and Budget
and ending December 31 of such Calendar Year, such partial year shall constitute
a full Calendar Year for purposes of this Section 3.1.7(b), and such Late Stage
Development Plan and Budget shall include such a budget for such partial year
and two (2) Calendar Years thereafter and (ii) if less than six (6) months
remain in the then-current Calendar Year commencing as of the date of such Late
Stage Development Plan and Budget and ending December 31 of such Calendar Year,
such Late Stage Development Plan and Budget shall include such a budget for such
partial Calendar Year and for three (3) Calendar Years thereafter (each such
budget, a “Post-Approval Development Budget”). The first full Calendar Year plus
any such partial Calendar Year, if applicable, of the then-current Post-Approval
Development Budget shall be binding, and the second and third full Calendar
Years of the Post-Approval Development Budget shall be non-binding. The initial
Post-Approval Development Budget, and each update thereto, will be prepared by
the Parties based on each Party’s good faith estimation, consistent with its
standard internal practices, of the probable Development activities to be
conducted during the relevant Post-Approval Development Budget period, and based
on and consistent with the documents and information related to the
Collaboration Products prepared by such Party for its internal use and reference
in the budgeting process. Upon request by a Party, the JFC shall discuss the
appropriate level of detail to include in a Post-Approval Development Budget for
the applicable Development activities to be performed during the period covered
by such Post-Approval Development Budget.

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3.1.8    Amendments to Development Plans and Budgets.
(a)    The Lead Party, in consultation with the Participating Party, shall (i)
review each Development Plan and Budget at least annually during the period
covered by such Development Plan and Budget for the purpose of considering
appropriate amendments thereto to be proposed to the JDC and (ii) then no later
than September 15 of the then-current Calendar Year beginning with the first
full Calendar Year of the initial Development Plan and Budget, provide the JDC
with a proposed updated Development Plan and Budget for the JDC’s review,
discussion and potential modification prior to submission of such updated
Development Plan and Budget by the JDC to the JSC. Based on its review of the
Lead Party’s proposed updated Development Plan and Budget and within thirty (30)
days after the receipt of such proposal, the JDC shall propose to the JSC an
updated Development Plan and Budget. The JSC shall endeavor to approve such
updated Development Plan and Budget no later than November 15 of the
then-current Calendar Year.
(b)    Annual updates to each Development Budget shall contain a proposed
Development Budget covering (i) the next Calendar Year, broken down by Calendar
Quarter, and (ii) each of the two (2) Calendar Years thereafter, broken down by
Calendar Year, in each case ((i) through (ii)), in accordance with the
requirements set forth in Section 3.1.7(a). The annual updates to each
Development Budget shall further contain any proposed Development activities
that were not previously included as Development activities in the then-current
Development Plan and Budget (including any new indications).
(c)    Annual updates to each Post-Approval Development Budget shall contain a
proposed Post-Approval Development Budget covering (i) the next Calendar Year,
broken down by Calendar Quarter, and (ii) each of the two (2) Calendar Years
thereafter, broken down by Calendar Year, in each case ((i) and (ii)), in
accordance with the requirements set forth in Section 3.1.7(b).
(d)    In addition to the annual updates, either Party, through its
representatives on the JDC, may propose amendments to any Development Plan and
Budget at any time until such time as no further Development activities are
occurring or expected to occur under such Development Plan and Budget, including
amendments to add Development activities to such Development Plan and Budget and
amendments to any Development Phase Budget (including new indications).

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(e)    No annual update or material amendment to a Development Plan and Budget
shall be effective unless and until approved by the JSC (or the Executive
Officers pursuant to Section 2.6.3(b) [***]. No amendment to a Development Phase
Budget shall be effective unless and until approved by the JSC by consensus or
the Executive Officers pursuant to Section 2.6.3(b) or deemed approved by the
Participating Party [***] [or approved pursuant to Section 2.6.3(b)(vi)]15.
(f)    In the event that Development activities for any Collaboration Products
are approved by the JSC by consensus or the Executive Officers pursuant to
Section 2.6.3(b) (i.e., without [***] exercising its final decision-making
authority) [or pursuant to [***]]16, then the corresponding Baseline Annual
Development Plan and Budget (including, for clarity, the Development Plan and
Budget for the then-current Calendar Year) and the Development Phase Budget, if
applicable shall be adjusted to account for the costs and expenses for such
approved Development activities.

15 Note to Draft: Include this bracketed language only in Co-Co Collaboration
Agreements where (1) Alnylam is the initial Lead Party and (2) the Target
Program was a CNS Program under the Master Agreement.
16 Note to Draft: Include this bracketed language only in Co-Co Collaboration
Agreements where (1) Alnylam is the initial Lead Party and (2) the Target
Program was a CNS Program under the Master Agreement.

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3.1.9    Subcontracting. Each Party shall have the right to subcontract any of
its Development activities under this Agreement to a Third Party (a “Third Party
Provider”) without the other Party’s consent (provided that Alnylam shall not
subcontract any activities within the Alnylam Specific Activities or the Ongoing
Candidate Discovery Development Activities without Regeneron’s prior consent,
such consent not to be unreasonably withheld, conditioned or delayed, except
that Alnylam may subcontract those activities set forth on Schedule 3.1.9 to
those Third Party Providers as set forth on such schedule to the extent Alnylam
subcontracts such activities in the ordinary course of Alnylam’s business, which
schedule may be updated from time to time by the JSC to include additional Third
Party Providers upon Alnylam’s reasonable request and Regeneron’s consent, not
to be unreasonably withheld, conditioned or delayed); provided that any
subcontract entered into by a Party pursuant to this Section 3.1.9 must (a) be
in writing, (b) be consistent with the terms and conditions of this Agreement,
including containing confidentiality provisions at least as protective as those
contained in ARTICLE 9, and (c) provide the other Party with the same rights
with respect to any intellectual property arising from the subcontracted
activities as it would have if the subcontracting Party performed such
activities under this Agreement (except that with respect to any subcontract
entered into with a Third Party contract manufacturer, such Third Party may
retain ownership of any general manufacturing process improvement of general
application; provided that such Third Party grants the subcontracting Party a
sublicenseable license with respect to any such improvement to the extent
related to a Collaboration Product). Without limiting the foregoing, Alnylam
shall not subcontract any of its regulatory obligations under this Agreement to
a contract research organization unless Alnylam and its Affiliates use such
contract research organizations for similar regulatory activities in their
normal course of conduct with respect to their other products. In the event the
subcontracting Party seeks to subcontract with an academic, governmental,
not-for-profit or public institution and is unable to comply with subsection (c)
above, then the subcontracting Party may submit a written request to the other
Party for its consent to such subcontract through the Alliance Managers. If the
other Party fails to respond to such request within [***] weeks after receipt of
such written request, such request shall be deemed to have been approved, and
the subcontracting Party may proceed with the subcontract. In any event, the
subcontracting Party shall (x) oversee the performance by its subcontractors of
the activities subcontracted pursuant to this Section 3.1.9 in a manner that
would be reasonably expected to result in their timely and successful completion
and (y) be responsible and liable for the actions and omissions of its
subcontractors. No subcontracting pursuant to this Section 3.1.9 shall relieve
the subcontracting Party of any of its obligations, or the other Party of any of
its rights, under this Agreement.
3.1.10    [Proof of Principle Study. Promptly following mutual agreement on the
Proof of Principle Criteria by the Parties, in accordance with and more
particularly described in the

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Master Agreement, the Lead Party shall identify such Proof of Principle Criteria
in writing to the JSC. [***]
3.1.11    Compliance. Each Party shall perform or cause to be performed any and
all of its Development activities, including its activities under each
applicable Development Plan and Budget, in a good scientific manner and in
compliance with all Applicable Law.
3.1.12    Delivery Technology. At any time during the Term, either Party may
propose in writing to the other Party that a targeting ligand or other delivery
technology is or is not a type of Non-Relevant Organ Delivery Technology, as
measured by [***]. Within thirty (30) days of receiving such request, together
with reasonable supporting data from the requesting Party, if any, the
non-requesting Party may agree or object. Upon any such objection, the proposing
Party, if it so elects, may elect to invoke the dispute resolution process set
forth in Section 2.6.3(b)(v) to determine if a targeting ligand or other
delivery technology is or is not a type of Non-Relevant Organ Delivery
Technology. Upon any agreement by the Parties or resolution by the dispute
resolution process set forth in Section 2.6.3(b)(v), the JSC will record the
applicable classification of the targeting ligand or other delivery technology
in its minutes; provided that, for clarity, either Party shall have the right to
subsequently dispute the determination made pursuant to this Section 3.1.12 if
new information becomes available with respect to such targeting ligand or other
delivery technology, and if a new determination is made, the JSC minutes will be
updated to reflect such new determination (provided that if (a) there was an
initial determination made pursuant to this Section 3.1.12 that a particular
targeting ligand or other delivery technology was Non-Relevant Organ Delivery
Technology, and (b) it is subsequently determined that such targeting ligand or
other delivery technology is not Non-Relevant Organ Delivery Technology, [***].
3.1.13    siRNAs from Other Co-Co Collaboration Agreements or License
Agreements. [***]
3.1.14    Additional Collaboration Products. If (a) Regeneron is the Lead Party
and (b) prior to the Initiation of a Registration Enabling Trial for the first
Collaboration Product hereunder, Regeneron desires to Develop additional
Collaboration Products hereunder, [***].
3.1.15    Additional Permitted Dual Sequences. [***]
3.1.16    [Development of Collaboration Product for use with an Antibody. In the
event that the Lead Party desires to Develop the Collaboration Product for use
with an antibody (either as a Combination Product or for co-administration),
then, prior to including any such Development activities in a Development Plan
and Budget, the Lead Party shall discuss such Development with the Participating
Party.]17 
17 Note to Draft: Include this bracketed provision only when Alnylam is the
initial Lead Party in this Agreement.

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3.1.17    [***]
3.2    Development Costs.
3.2.1    Development Cost Sharing. Unless and until a Party exercises its
Opt-Out Right, subject to Section 3.2.2(a) and Section 3.2.2(b), the Parties
shall share Development Costs equally (50%/50%) pursuant to Section 7.1.1.
3.2.2    Development Budget Overruns and Option Thresholds.
(a)    Development Budget Overruns. For purposes of determining any budget
overages, where Development activities included in a Development Plan and Budget
are allocated to both Parties, the applicable Development Budget or the
Post-Approval Development Budget will be allocated between the Parties in
proportion to activities allocated to each Party in such plan, and if such
activities are allocated to only one Party, the applicable Development Budget or
Post-Approval Development Budget shall be allocated entirely to such Party.
[***]
(b)    Option Thresholds. With respect to each Development Plan and Budget,
[***].
3.3    Information Exchange. As long as a Party is conducting Development
activities under this Agreement, including under a Development Plan and Budget,
upon the reasonable request of such Party (the “Requesting Party”), the
non-Requesting Party shall provide to the Requesting Party Information that is
licensed to the other Party under this Agreement to the extent that it is
necessary or reasonably useful for the Requesting Party to perform its
Development activities under any Development Plan and Budget, or, with respect
to the Lead Party as the Requesting Party, for Developing any Collaboration
Product or for filing, obtaining or maintaining INDs or Regulatory Approval for
any Collaboration Product, including copies of all material scientific
information and data related to such Collaboration Product.
3.4    Records and Reports.
3.4.1    Each of Alnylam and Regeneron shall, and shall ensure that its Third
Party Providers, maintain complete, current and accurate records of all of its
Development activities under this Agreement, including under each Development
Plan and Budget, and all data and other information resulting from such
Development activities, which records shall (a) be in sufficient detail and in
good scientific manner appropriate for patent and regulatory purposes, and in
compliance with Applicable Law, (b) properly reflect all work done and results
achieved in the performance of such Development activities, and (c) record only
such Development activities and

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shall not include or be commingled with records of activities that are not
conducted under this Agreement. Alnylam or Regeneron, as the case may be, shall
retain, or cause to the retained, such records for at least three (3) years
after the termination of this Agreement, or for such longer period as may be
required by Applicable Law.
3.4.2    Until a Party exercises its Opt-Out Right, each Party shall promptly
provide to the JDC a summary of material non-clinical data and Clinical Data
with respect to any Development activities under each Development Plan and
Budget and, upon the reasonable request by the other Party, shall provide the
other Party copies of or access to all non-clinical data and Clinical Data, and
other material Information, results, and analyses (including clinical safety
data affecting each Collaboration Product or the class (e.g., serious adverse
events, emerging safety issues) and other reasonable information to enable
Alnylam to conduct platform-wide safety signal analyses) with respect to such
Development activities (collectively, “Development Data”). If requested by a
Party, the Parties shall reasonably agree on timelines to provide such
Development Data, and in particular with respect to clinical safety data (but
without limiting the foregoing), prior to IND submission to the FDA for the
first Collaboration Product, the Parties shall reasonably agree (via the JDC or
otherwise) on timelines and procedures for exchange of such safety data and
regular meetings of safety personnel, in each case, in order for the Parties to
be able to comply with any regulatory reporting requirements.
3.4.3    If a Party exercises its Opt-Out Right, within thirty (30) days
following the end of each Calendar Year during which the Lead Party is
conducting Development activities, the Lead Party shall provide the
Participating Party a summary of material Development activities and shall
promptly notify the Participating Party of material developments in the
Development and Regulatory Approval of the Collaboration Products in the Major
Market Countries.
3.4.4    Notwithstanding anything to the contrary contained herein (including
Sections 3.6.1 and 5.1.1), neither Party shall be required to provide to, or
otherwise share with, the other Party any data (including Development Data and
CMC information) specific to such Party’s Proprietary Unlicensed Component,
unless otherwise required by a Regulatory Authority.
3.5    Opt-Out Rights.
3.5.1    Each Party shall have the right, subject to Section 3.5.7, to opt-out
of its obligation to perform any further Development activities under this
Agreement (except, with respect to Alnylam, the continued performance of the
Alnylam Specific Activities subject to Section 3.5.7(b)) and its obligation to
pay for fifty percent (50%) of the future Development Costs (except, with
respect to either Party, the continued obligation to share Development Costs
pursuant to Section 3.5.7(e), as applicable) (the “Opt-Out Right”) by providing
written notice of such exercise (an “Opt-Out Notice”, and the date such Opt-Out
Notice is provided, the “Opt-Out Date”)

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to the other Party within thirty (30) days after the JSC (or the Executive
Officers pursuant to Section 2.6.3(b) [***]) approves the initial Phase 2
Development Plan and Budget.
3.5.2    If a Party has not previously exercised its Opt-Out Right, each Party
shall have the right, subject to Section 3.5.7, to exercise its Opt-Out Right by
providing an Opt-Out Notice to the other Party within thirty (30) days after the
JSC (or the Executive Officers pursuant to Section 2.6.3(b) [***]) approves the
initial Late Stage Development Plan and Budget.
3.5.3    If a Party has not previously exercised its Opt-Out Right, each Party
shall have the right, subject to Section 3.5.7, to exercise its Opt-Out Right by
providing an Opt-Out Notice to the other Party at any time after the JSC (or the
Executive Officers pursuant to Section 2.6.3(b) [***]) approves the initial
Phase 2 Development Plan and Budget (but not during the period that is
(a) within thirty (30) days after the date that the JSC (or the Executive
Officers pursuant to Section 2.6.3(b) [***]) approves the initial Phase 2
Development Plan and Budget, which would be handled pursuant to Section 3.5.1,
or (b) within thirty (30) days after the date that the JSC (or the Executive
Officers pursuant to Section 2.6.3(b) [***]) approves the initial Late Stage
Development Plan and Budget, which would be handled pursuant to Section 3.5.2).
3.5.4    If a Party has not previously exercised its Opt-Out Right, the
Participating Party may exercise its Opt-Out Right pursuant to Section 3.2.2(b);
provided, however, that if a Party exercises its Opt-Out Right pursuant to this
Section 3.5.4 before the JSC (or the Executive Officers pursuant to
Section 2.6.3(b) or the Lead Party pursuant to Section 2.6.3(b)(i)) approves the
initial Phase 1 Development Plan and Budget, then the Parties shall negotiate in
good faith whether to change (and if so, the change to) the royalty rates in
Section 7.2.1(a) and the Third Party Transaction Proceeds Percentage based on
such Party’s contribution to the Development of the Collaboration Products, the
status of the Collaboration Products and the commercial prospects for the
Collaboration Products.
3.5.5    If a Party has not previously exercised its Opt-Out Right, as a limited
exception to the exclusivity obligation in Section 6.7.1, the Acquired Party may
exercise its Opt-Out Right in the event an Acquirer has a Competing Program at
the time of the closing of the Third Party Acquisition by providing an Opt-Out
Notice to the other Party within ten (10) Business Days after the closing of the
Third Party Acquisition for the Acquired Party; provided, however, that if the
Acquired Party exercises its Opt-Out Right pursuant to this Section 3.5.5 before
the JSC (or the Executive Officers pursuant to Section 2.6.3(b) [***]) approves
the initial Phase 1 Development Plan and Budget, then the Parties shall
negotiate in good faith whether to change (and if so, the change to) the royalty
rates in Section 7.2.1(a) and the Third Party Transaction Proceeds Percentage
based on the Acquired Party’s contribution to the Development of the
Collaboration Products, the status of the Collaboration Products and the
commercial prospects for the Collaboration Products.

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3.5.6    [***]
3.5.7    Any Opt-Out Notice shall indicate the subsection of Section 3.5 under
which such Party is exercising its Opt-Out Right. If a Party exercises its
Opt-Out Right pursuant to Section 3.5.1, Section 3.5.2, Section 3.5.3,
Section 3.5.4 or Section 3.5.5 [or Section 3.5.6]18 (such Party, the “Opt-Out
Party”), then:
(a)    if the Opt-Out Party is the Party that is the Lead Party immediately
prior to exercising its Opt-Out Right, then the provisions of Schedule 3.5.7(a)
shall apply;
(b)    subject to Section 3.5.7(a), the Opt-Out Party shall no longer have any
obligation to perform any Development activities with respect to any
Collaboration Product, except that if Alnylam is the Opt-Out Party, Alnylam
shall still be required to, at Regeneron’s request, perform the Alnylam Specific
Activities and use Commercially Reasonable Efforts to perform such Alnylam
Specific Activities in accordance with a plan and budget to be reasonably agreed
to by the Parties (which budget shall include a mutually agreeable mechanism to
address payments by Regeneron to Alnylam for cost overruns that are no more than
[***] over the budget); provided that, (i) in the event of a dispute with
respect to such plan (including if the Parties are unable to reasonably agree on
such plan or amendments thereto), such dispute shall be resolved by Regeneron,
provided that Regeneron shall not have the right to include activities in such
plan that are not Alnylam Specific Activities and (ii) in the event of a dispute
with respect to such budget (including if the Parties are unable to reasonably
agree on such budget or amendments thereto), such dispute shall be a Financial
Dispute. Regeneron shall pay Alnylam the Alnylam Specific Activities Costs with
respect thereto pursuant to Section 7.2.10;
(c)    the Lead Party (which may be a New Lead Party, if applicable) shall no
longer be required to prepare any Development Plan and Budget, Commercialization
Plan and Budget, or any amendments or updates thereto;
(d)    the Joint Committees shall automatically terminate and, at the Lead
Party’s (which may be a New Lead Party, if applicable) request, the Parties
shall form a joint working group for the coordination of regulatory,
pharmacovigilance and Manufacturing matters, or any other matters as reasonably
requested by the Lead Party, after the Opt-Out Date;

18 Note to Draft: Include this bracketed language only in Co-Co Collaboration
Agreements where (1) Alnylam is the initial Lead Party and (2) the Target
Program was a CNS Program under the Master Agreement.

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(e)    except as set forth in Section 3.5.7(e)(i) through Section 3.5.7(e)(iv),
or as otherwise provided in this Agreement, the Opt-Out Party shall no longer be
responsible for any of the Development Costs, Shared Commercial Expenses or
Other Shared Expenses that are incurred after the Opt-Out Date and the Lead
Party (which may be a New Lead Party, if applicable) shall be responsible for
all costs and expenses incurred in connection with the Development and
Commercialization or of the Collaboration Products thereafter;
(i)    if the Opt-Out Party exercises its Opt-Out Right pursuant to
Section 3.5.1 or Section 3.5.5 after the JSC (or the Executive Officers pursuant
to Section 2.6.3(b) [***]) approval of the initial Phase 1 Development Plan and
Budget but prior to the completion of the Development activities under the Phase
1 Development Plan and Budget (regardless of whether the Phase 1 Completion Date
has occurred), then [***];
(ii)    if the Opt-Out Party exercises its Opt-Out Right pursuant to
Section 3.5.2 or Section 3.5.5 after the JSC (or the Executive Officers pursuant
to Section 2.6.3(b) [***]) approval of the initial Phase 2 Development Plan and
Budget but prior to the completion of the Development activities under the Phase
2 Development Plan and Budget (regardless of whether the Phase 2 Completion Date
has occurred), [***];
(iii)    if the Opt-Out Party exercises its Opt-Out Right pursuant to
(1) Section 3.5.5 after the JSC (or the Executive Officers pursuant to
Section 2.6.3(b) [***]) approval of the initial Late Stage Development Plan and
Budget or (2) Section 3.5.3, then (A) if the Opt-Out Party exercises its Opt-Out
Right prior to the First Commercial Sale of the first Collaboration Product in
the first Major Market Country, [***], and (B) if the Opt-Out Party exercises
its Opt-Out Right after the First Commercial Sale of the first Collaboration
Product in the first Major Market Country, then the Parties shall continue to
share the Development Costs for activities set forth in the Post-Approval
Development Budget as of the Opt-Out Date, [***] until the [***] anniversary of
the Opt-Out Date;
(iv)    if the Opt-Out Party exercises its Opt-Out Right pursuant to
Sections 3.5.4 [or 3.5.6]19, then the Parties shall continue to share [***] the
Development Costs until the [***] day following the exercise of such Opt-Out
Right up to the Development Phase Budget for the applicable Development Plan and
Budget;
(f)    the Parties shall not share Profits [***] pursuant to Section 7.1 and the
provisions of Section 7.2 shall apply;
19 Note to Draft: Include this bracketed language only in Co-Co Collaboration
Agreements where (1) Alnylam is the initial Lead Party and (2) the Target
Program was a CNS Program under the Master Agreement.

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(g)    if the Lead Party is the Opt-Out Party, the licenses granted by the
Participating Party to the old Lead Party under Section 6.1.1 through
Section 6.1.4 shall terminate and the old Lead Party shall grant the
Participating Party (which shall be the New Lead Party) the licenses set forth
in Section 6.2.2;
(h)    if the Opt-Out Party exercises its Opt-Out Right pursuant to
Section 3.5.4, the Opt-Out Party shall have the right pursuant to Section 7.2.6
to recoup the Development Costs it incurred pursuant to Section 7.1.1 with
respect to the Development Phase Budget Period during which it exercised its
Opt-Out Right other than any Development Costs for which the Opt-Out Party was
either reimbursed or which were otherwise covered by Third Party Transaction
Proceeds (“Opt-Out Development Costs”);
(i)    if, prior to exercising its Opt-Out Right, the Opt-Out Party received any
Third Party Transaction Proceeds as pre-payment of Development Costs, but as of
the Opt-Out Date, the Opt-Out Party has not actually incurred Development Costs
equal to the amount of such pre-paid Third Party Transaction Proceeds, then the
Opt-Out Party shall pay the Lead Party (which may be the New Lead Party), as of
the later of the Opt-Out Date and the date the Opt-Out Party is no longer
responsible pursuant to Section 3.5.7(e) for any applicable Development Costs,
any amount of such pre-paid Third Party Transaction Proceeds that remains after
application of such pre-paid Third Party Transaction Proceeds to Development
Costs incurred by the Opt-Out Party prior to such date; and
3.6    Regulatory Matters.
3.6.1    Regulatory Responsibilities.
(a)    As between the Parties, the Lead Party shall, subject to
Section 3.6.1(c), have the sole right to prepare, obtain, and maintain INDs,
Drug Approval Applications (including the setting of the overall regulatory
strategy therefor), other Regulatory Approvals and other submissions, and to
conduct communications with the Regulatory Authorities, for Collaboration
Products in the Territory (which shall include filings or communications with
the Regulatory Authorities with respect to Development activities) during such
time as it is the Lead Party. The Participating Party shall support the Lead
Party, as reasonably requested by the Lead Party, in obtaining INDs and
Regulatory Approvals for the Collaboration Products, and in the activities in
support thereof, including providing documents or other materials necessary or
reasonably useful to obtain any such INDs and Regulatory Approvals and
consulting with respect thereto. [***]

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(b)    All Regulatory Documentation (including all Regulatory Approvals and
Product Labeling) relating to the Collaboration Products shall be owned by, and
shall be the sole property and held in the name of, the Lead Party or its
designated Affiliate, Sublicensee or designee.
(c)    [***]
(i)    [***]
(ii)    The Lead Party shall provide the Participating Party with prior written
notice, to the extent the Lead Party has advance knowledge, of any scheduled
meeting (including any advisory committee meeting) with a Regulatory Authority
in a Major Market Country relating to a Collaboration Product, within [***]
Business Days after the Lead Party first receives notice of the scheduling of
such meeting (or within such shorter period as may be necessary in order to give
the Participating Party a reasonable opportunity to attend such meeting). [***]
(d)    [***]
3.6.2    Recall, Market Suspension or Market Withdrawal. The Lead Party shall
make every reasonable effort to notify the Participating 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 a Collaboration Product in
the Territory, and shall include in such notice the reasoning behind such
determination, and any supporting facts. The Lead Party shall have the right to
make the final determination whether to voluntarily implement any such recall,
market suspension, or market withdrawal in the Territory; provided, unless and
until a Party exercises its Opt-Out Right, that prior to any implementation of
such a recall, market suspension, or market withdrawal, the Lead Party shall, to
the extent practicable, consult with the Participating Party and shall consider
the Participating Party’s comments in good faith. If a recall, market
suspension, or market withdrawal is mandated by a Regulatory Authority in the
Territory, the Lead Party shall initiate such a recall, market suspension, or
market withdrawal in compliance with Applicable Law. For all recalls, market
suspensions or market withdrawals undertaken pursuant to this Section 3.6.2, the
Lead Party shall be solely responsible for the execution thereof, and the
Participating Party shall reasonably cooperate in all such recall efforts.
Without limiting ARTICLE 11, (a) if and to the extent that a recall, market
suspension, or market withdrawal resulted from a Party’s or any of its
Affiliate’s material breach of its obligations hereunder, or from such Party’s
or any of its Affiliate’s gross negligence or willful misconduct, such Party
shall be responsible for the costs and expenses of such recall, market
suspension, or market withdrawal incurred by or on behalf of either Party, (b)
unless a Party has exercised its Opt-Out Right, except as set forth in the
foregoing clause (a), the costs and expenses incurred by or on behalf of either
Party as a result of a recall, market suspension, or market withdrawal

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of a Collaboration Product shall be included in Other Shared Expenses, and (c)
if a Party has exercised its Opt-Out Right, except as set forth in the foregoing
clause (a), the Lead Party shall be responsible for the costs and expenses of
such recall, market suspension, or market withdrawal incurred by or on behalf of
either Party.
3.7    Material Transfer. In the event a Party transfers to the other Party any
Materials under this Agreement, the receiving Party shall: (a) use such
Materials solely for the purpose of exercising its rights or fulfilling its
obligations under this Agreement and for no other purpose; and (b) not transfer
such Materials to any Third Party without the providing Party’s prior written
consent, provided that the receiving Party shall have the right to transfer such
Materials to its Sublicensees or subcontractors solely to the extent for such
Third Party to conduct the activities on behalf of, or as a Sublicensee of, such
receiving Party in furtherance of this Agreement. In the event the Parties
anticipate the transfer of any patient samples or patient information, the
Parties shall negotiate in good faith and enter into an agreement governing such
transfer and subsequent use, in compliance with all Applicable Law.
3.8    [***]
ARTICLE 4    
COMMERCIALIZATION
4.1    In General. The Lead Party (itself or through its Affiliates or
Sublicensees) shall have the sole right to Commercialize Collaboration Products
in the Territory.
4.2    Commercialization Plan and Budget.
4.2.1    General. The Commercialization of the Collaboration Products in the
Territory shall be conducted pursuant to the Commercialization Plan and Budget,
which shall at a minimum include a reasonably detailed plan for the Detailing
and Commercialization of the Collaboration Product in the United States and each
other Major Market Country, on a country-by-country basis, and shall further
provide that during the first three (3) Calendar Years following the First
Commercial Sale of a Collaboration Product in the United States, such
Collaboration Product will be Detailed in the primary or secondary position in
the United States. The Parties acknowledge and agree that the FTE time necessary
to perform a secondary or tertiary Detail is expected to be less than the FTE
time necessary to perform a primary position Detail, which would result in the
Field Force Costs for secondary and tertiary Details being less than the Field
Force Costs for primary Details. At least twenty-four (24) months prior to the
Anticipated FCS Date for the first Collaboration Product in the first country in
the Territory, the Lead Party shall provide the JCC with a proposed initial
Commercialization Plan and Budget for the JCC’s review, discussion and potential
modification prior to submission of the initial Commercialization Plan and
Budget by the JCC to the JSC for review and approval. Based on its review of the
Lead Party’s proposed initial

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Commercialization Plan and Budget and within thirty (30) days after receipt of
such proposal, the JCC shall propose to the JSC an initial Commercialization
Plan and Budget. The JSC shall endeavor to approve the initial Commercialization
Plan and Budget at least eighteen (18) months prior to such Anticipated FCS
Date. The initial Commercialization Plan and Budget shall not be effective
unless and until approved by the JSC (or the Executive Officers pursuant to
Section 2.6.3(b) or the Lead Party pursuant to Section 2.6.3(b)(i)).
4.2.2    Commercialization Budgets. The Commercialization Plan and Budget will
contain a three (3)-Calendar Year rolling budget for the probable Shared
Commercial Expenses for the Commercialization activities to be performed during
the then-current Calendar Year (broken down by Calendar Quarter) and the next
two (2) Calendar Years (broken down by Calendar Year) of the Commercialization
Plan and Budget, updated on a rolling three (3)-Calendar Year period basis;
provided that (a) if six (6) months or more remain in the then-current Calendar
Year commencing as of the date of such initial Commercialization Plan and Budget
and ending December 31 of such Calendar Year, such partial year shall constitute
a full Calendar Year for purposes of this Section 4.2.2, and such initial
Commercialization Plan and Budget shall include such a budget for such partial
year and two (2) Calendar Years thereafter (broken down by Calendar Quarter for
the first full Calendar Year and the stub period) and (b) if less than six (6)
months remain in the then-current Calendar Year commencing as of the date of
such initial Commercialization Plan and Budget and ending December 31 of such
Calendar Year, such initial Commercialization Plan and Budget shall include such
a budget for such partial Calendar Year and for three (3) Calendar Years
thereafter (broken down by Calendar Quarter for the first full Calendar Year and
the stub period) (each such budget, a “Commercialization Budget”). The first
full Calendar Year plus any such partial Calendar Year, if applicable, of the
then-current Commercialization Budget shall be binding, and the second and third
full Calendar Years of the Commercialization Budget shall be non-binding. The
initial Commercialization Budget for the Commercialization Plan and Budget, and
each update thereto, will be prepared by the Parties based on each Party’s good
faith estimation, consistent with its standard internal practices, of the
probable Commercialization activities to be conducted during the relevant
Commercialization Budget period, and based on and consistent with the documents
and information related to the Collaboration Products prepared by such Party for
its internal use and reference in the budgeting process. Upon request by a
Party, the JFC shall discuss the appropriate level of detail to include in a
Commercialization Budget for the applicable Commercialization activities to be
performed during the period covered by such Commercialization Budget.
4.2.3    Amendments to Commercialization Plans and Budgets. The Lead Party, in
consultation with the Participating Party, shall (a) review the
Commercialization Plan and Budget at least annually for the purpose of
considering appropriate amendments thereto to be proposed to the JCC and (b)
then no later than September 15 of the then-current Calendar Year beginning with
the first full Calendar Year of the initial Commercialization Plan and Budget,
provide the JCC with a proposed updated Commercialization Plan and Budget for
the JCC’s review, discussion and

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potential modification prior to submission of such updated Commercialization
Plan and Budget by the JCC to the JSC. Based on its review of the Lead Party’s
proposed updated Commercialization Plan and Budget and within thirty (30) days
after receipt of such proposal, the JCC shall propose to the JSC an updated
Commercialization Plan and Budget. The JSC will endeavor to approve such updated
Commercialization Plan and Budget no later than November 15 of the then-current
Calendar Year. Annual updates to the Commercialization Budget shall contain a
proposed Commercialization Budget covering (i) the next Calendar Year, broken
down by Calendar Quarter, and (ii) each of the two (2) Calendar Years
thereafter, broken down by Calendar Year, in each case ((i) and (ii)), in
accordance with the requirements set forth in Section 4.2.2. In addition to the
annual update, either Party, through its representatives on the JCC, may propose
amendments to the Commercialization Plan and Budget at any time. No update or
amendment to the Commercialization Plan and Budget shall be effective unless and
until approved by the JSC (or the Executive Officers pursuant to
Section 2.6.3(b) [***]).
4.3    Diligence. The Lead Party shall use Commercially Reasonable Efforts to
Commercialize a Collaboration Product [***] following receipt of Regulatory
Approval therefor in the applicable country in the Territory.
4.4    Compliance with Applicable Law. The Lead Party shall, and shall cause its
Affiliates to, comply with all Applicable Law with respect to the
Commercialization of Collaboration Products.
4.5    Booking of Sales; Distribution. The Lead Party shall have the sole right
to invoice and book sales, establish all terms of sale (including pricing and
discounts) and warehousing, and distribute the Collaboration Products in the
Territory and to perform or cause to be performed all related services. The Lead
Party shall handle all returns, recalls, or withdrawals, order processing,
invoicing, collection, distribution, and inventory management with respect to
the Collaboration Products in the Territory.
4.6    Promotional Materials. The Lead Party will be responsible, consistent
with the Commercialization Plan and Budget, for the creation, preparation,
production and reproduction of all Promotional Materials and for filing, as
appropriate, all Promotional Materials with all Regulatory Authorities in the
world.
4.7    Product Trademarks and Domain Names. Subject to Section 4.8, the Lead
Party shall have the right, in consultation with the Participating Party unless
the Participating Party has exercised its Opt-Out Right, to determine and shall
own the Product Trademarks and Domain Names to be used with respect to the
Exploitation of the Collaboration Products on a worldwide basis. Neither Party
shall, nor it permit its Affiliates to, (a) use in their respective businesses
(except, with respect to the Lead Party, under this Agreement), any Trademark
that is confusingly similar to,

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misleading or deceptive with respect to or that dilutes any (or any part) of the
Product Trademarks and Domain Names, or (b) do any act that endangers, destroys,
or similarly affects, in any material respect, the value of the goodwill
pertaining to the Product Trademarks and Domain Names.
4.8    Use of Corporate Names.
4.8.1    Unless and until a Party exercises its Opt-Out Right, the Lead Party
shall use Commercially Reasonable Efforts to include the Participating Party’s
Corporate Name with equal prominence on materials related to the Collaboration
Products (including Product Labeling, trade packaging, internet pages, social
media, samples and all Promotional Materials used or distributed in connection
with the Collaboration Products), unless to do so would be prohibited under
Applicable Law; provided, in the case of multi-product materials that refer to a
Collaboration Product as well as other (bio)pharmaceutical products, the
prominence of the Participating Party’s Corporate Name shall be commensurate
with the relative prominence of such Collaboration Product in such materials.
4.8.2    If a Party exercises its Opt-Out Right, the Lead Party shall have no
obligation to include the Participating Party’s Corporate Names on materials
related to the Collaboration Products (including Product Labeling, trade
packaging, internet pages, social media, samples and all Promotional Materials
used or distributed in connection with the Collaboration Products), except that
to the extent the Lead Party is required under Applicable Law to include the
Participating Party’s Corporate Names on materials related to the Collaboration
Product (including Product Labeling, trade packaging, internet pages, social
media, samples and all Promotional Materials used or distributed in connection
with the Collaboration Products) it shall do so.
4.8.3    During the Term, the Lead Party shall submit samples of each such
Product Labeling, trade packaging, internet pages, social media, samples and
Promotional Materials containing the Participating Party’s Corporate Name to the
Participating Party for its prior approval (which approval shall not be
unreasonably withheld, conditioned or delayed) at least fifteen (15) days before
the first dissemination of such materials. Failure of the Participating Party to
object within such fifteen (15)-day period shall constitute approval of the Lead
Party’s Product Labeling, trade packaging, internet pages, social media, samples
and all Promotional Materials.
4.9    Commercialization Reports.
4.9.1    Unless and until a Party exercises its Opt-Out Right, commencing upon
approval of the initial Commercialization Plan and Budget, promptly after the
end of each Calendar Quarter, each Party shall provide to the JCC a summary of
material Commercialization activities undertaken by or on behalf of such Party
with respect to each Collaboration Product in the Field during such Calendar
Quarter, and upon the reasonable request of the other Party, shall provide the
other Party with copies of or access to any other material Information and
analyses with respect to such Commercialization activities.

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4.9.2    If a Party has exercised its Opt-Out Right, approximately twenty-four
(24) months prior to, and again approximately twelve (12) months prior to, the
expected date of First Commercial Sale of a Collaboration Product, the Lead
Party shall provide the Participating Party a written report (in electronic
form) summarizing the Commercialization activities (if any) undertaken by or on
behalf of the Lead Party with respect to each Collaboration Product in the Field
during such Calendar Year. Commencing with the First Commercial Sale of a
Collaboration Product in the Territory, such reports shall be provided two (2)
times per Calendar Year (for the first two Calendar Quarters and for the last
two Calendar Quarters of each Calendar Year). The foregoing reports referred to
in this Section 4.9.2 shall be in a level of detail that will provide the
Participating Party with an update on the progress of the Commercialization
activities. In addition, interim versions of such reports may be requested by
the Participating Party with respect to the first Calendar Quarter and third
Calendar Quarter of each Calendar Year, it being understood that such interim
reports may be less detailed than the regular reports covering two (2) Calendar
Quarters.
4.9.3    The Lead Party shall maintain records relating to its sales force,
account management, medical science liaison and medical affairs functions FTEs
for the Collaboration Products in each country in a manner sufficient to permit
the determination of Field Force Cost.
4.10    Commercialization Costs.
4.10.1    Shared Commercial Expenses. Unless a Party exercises its Opt-Out
Right, subject to Section 4.10.2, the Parties shall share Shared Commercial
Expenses evenly (50%/50%) pursuant to Section 7.1.1.
4.10.2    Commercialization Budget Overruns. Where Commercialization activities
included in a Commercialization Plan and Budget are allocated [***].
4.10.3    After Opt-Out. Except as otherwise provided in this Agreement, if
either Party exercises its Opt-Out Right, then the Opt-Out Party shall no longer
be responsible for any of the Shared Commercial Expenses or Other Shared
Expenses that are incurred after the Opt-Out Date, and the Lead Party (which may
be a New Lead Party, if applicable), shall be responsible for all costs and
expenses incurred in connection with the Commercialization of the Collaboration
Products.

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ARTICLE 5    
MANUFACTURING AND SUPPLY
5.1    Manufacturing Coordination.
[***]
5.2    Early Stage Supply Requirements.
5.2.1    If Regeneron is the Lead Party, Alnylam shall use Commercially
Reasonable Efforts to adequately and timely Manufacture and supply the Early
Stage Supply Requirements, which Manufacture and supply shall be in accordance
with Applicable Law, including GMP, and this Agreement (including the
Manufacturing Plan), as well as the Supply Agreement and the Quality Agreement
once the Parties have executed the Supply Agreement and the Quality Agreement.
If Alnylam is the Lead Party, Alnylam shall use Commercially Reasonable Efforts
to adequately and timely Manufacture and supply the Early Stage Supply
Requirements, which Manufacture and supply shall be in accordance with
Applicable Law, including GMP, and this Agreement (including the Manufacturing
Plan).
5.2.2    If Regeneron is the Lead Party, the Parties shall negotiate in good
faith and use diligent and good faith efforts to execute and deliver a
definitive supply agreement for the supply of the Early Stage Supply
Requirements (the “Supply Agreement”) and related quality agreement (the
“Quality Agreement”) [***].
5.2.3    If Alnylam is the Lead Party, then Alnylam shall comply with the terms
of Schedule 5.2.3 with respect to the Manufacture and supply of Early Stage
Supply Requirements.
5.2.4    Alnylam shall be responsible for supplying the Early Stage Supply
Requirements. [***]
5.2.5    [***]
5.3    Late Stage Supply Requirements.
5.3.1    Determination of Manufacturer for Late Stage Supply Requirements.
(a)    Prior to Opt-Out. [***]
(b)    Following Opt-Out. Notwithstanding Section 5.3.1(a), [***].
5.3.2    Regeneron as Lead Party with Alnylam as the Manufacturer. [***].
5.3.3    Regeneron as Lead Party with Regeneron as the Manufacturer.

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(a)    Technology Transfer. [***]
(b)    Additional Technology Transfers. Without limiting the foregoing, [***].
(c)    Contracts with Third Party Contract Manufacturers. [***]
(d)    Efforts. [***]
5.3.4    [***] as the Lead Party. [***]
5.4    Technology Transfer to Alnylam. [***]
5.5    Costs of Manufacture.
[***]
5.6    Certain Alnylam Third Party Contractor Requirements. [***]
5.7    Development of Delivery Systems for Collaboration Products. [***]
5.8    Fill-Finish Manufacturing Activities for Collaboration Products. [***]
ARTICLE 6    
GRANT OF RIGHTS
6.1    [Grants to Regeneron. Subject to the terms and conditions of this
Agreement, Alnylam hereby grants Regeneron:20]
6.1.1    subject to Section 6.4.3, for so long as Regeneron does not exercise
its Opt-Out Right, an exclusive (including with regard to Alnylam and its
Affiliates), non-transferable (except as permitted by Section 13.2), worldwide
license (or sublicense), with the right to grant sublicenses in accordance with
Section 6.3, under the Alnylam Product-Specific Patents and the Alnylam
Product-Specific Know-How, to perform activities under a Development Plan and
Budget and to Exploit the Collaboration Products in the Field in the Territory,
which license shall be (a) if neither Party exercises its Opt-Out Right,
payment-bearing pursuant to Section 7.1 during the Term and (b) if Alnylam
exercises its Opt-Out Right, royalty-bearing pursuant to Section 7.2.1 during
the Royalty Term with respect to each Collaboration Product in each country in
the Territory, and after the expiration of the Royalty Term for a Collaboration
Product in a country shall convert to a fully paid-up, irrevocable, perpetual,
non-exclusive license, with the right to grant sublicenses through multiple
tiers of sublicensees, for such Collaboration Product in such country;
20 Note to Draft: If Alnylam is the initial Lead Party, then this Section 6.1
should be replaced with the Alternative Section 6.1 set forth at the end of this
Section 6.1.

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6.1.2    for so long as Regeneron does not exercise its Opt-Out Right, a
non-exclusive, non-transferable (except as permitted by Section 13.2), worldwide
license (or sublicense), with the right to grant sublicenses in accordance with
Section 6.3, under the Alnylam Core Technology Patents and the Alnylam Core
Technology Know-How, to perform activities under a Development Plan and Budget
and to Exploit the Collaboration Products in the Field in the Territory, which
license shall be (a) if neither Party exercises its Opt-Out Right,
payment-bearing pursuant to Section 7.1 during the Term and (b) if Alnylam
exercises its Opt-Out Right, royalty-bearing pursuant to Section 7.2.1 during
the Royalty Term with respect to each Collaboration Product in each country in
the Territory, and after the expiration of the Royalty Term for a Collaboration
Product in a country shall convert to a fully paid-up, irrevocable, perpetual,
non-exclusive license, with the right to grant sublicenses through multiple
tiers of sublicensees, for such Collaboration Product in such country;
6.1.3    subject to Section 6.4.3, for so long as Regeneron does not exercise
its Opt-Out Right, an exclusive (including with regard to Alnylam and its
Affiliates), non-transferable (except as permitted by Section 13.2), fully
paid-up, worldwide license and right of reference, with the right to grant
sublicenses and further rights of reference in accordance with Section 6.3,
under the Regulatory Approvals and any other Regulatory Documentation that
Alnylam or its Affiliates may Control that are related to a Collaboration
Product as necessary for purposes of performing any activities under a
Development Plan and Budget and for Exploiting such Collaboration Product in the
Field in the Territory;
6.1.4    for so long as Regeneron does not exercise its Opt-Out Right, a
non-exclusive license, with the right to grant sublicenses in accordance with
Section 6.3, to use Alnylam’s Corporate Names solely as required to comply with,
and in accordance with, Section 4.8, and for no other purpose; and
6.1.5    a non-exclusive, non-transferable (except as permitted by
Section 13.2), fully paid-up, perpetual, worldwide license (or sublicense), with
the right to grant sublicenses through multiple tiers, [***] to Exploit any
product in the Territory that does not contain any siRNA, MicroRNA, MicroRNA
antagonist or MicroRNA Mimic, or any single or double-stranded oligonucleotide
designed to specifically hybridize to RNA and modulate the expression of the
intended target.
Notwithstanding the foregoing in this Section 6.1, Regeneron does not receive
any rights under the license grants in this Section 6.1 to or for any
Proprietary Unlicensed Component of a Combination Product Controlled by Alnylam
(or any of its Affiliates).

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6.1    [ALTERNATIVE SECTION 6.1] [Grants to Alnylam. Subject to the terms and
conditions of this Agreement, Regeneron hereby grants Alnylam:21]
6.1.1    subject to Section 6.4.3, for so long as Alnylam does not exercise its
Opt-Out Right, an exclusive (including with regard to Regeneron and its
Affiliates), non-transferable (except as permitted by Section 13.2), worldwide
license (or sublicense), with the right to grant sublicenses in accordance with
Section 6.3, under the Regeneron Product-Specific Patents and the Regeneron
Product-Specific Know-How, to perform activities under a Development Plan and
Budget and to Exploit the Collaboration Products in the Field in the Territory,
which license shall be (a) if neither Party exercises its Opt-Out Right,
payment-bearing pursuant to Section 7.1 during the Term and (b) if Regeneron
exercises its Opt-Out Right, royalty-bearing pursuant to Section 7.2.1 during
the Royalty Term with respect to each Collaboration Product in each country in
the Territory, and after the expiration of the Royalty Term for a Collaboration
Product in a country shall convert to a fully paid-up, irrevocable, perpetual,
non-exclusive license, with the right to grant sublicenses through multiple
tiers of sublicensees, for such Collaboration Product in such country;
6.1.2    for so long as Alnylam does not exercise its Opt-Out Right, a
non-exclusive, non-transferable (except as permitted by Section 13.2), worldwide
license (or sublicense), with the right to grant sublicenses in accordance with
Section 6.3, under the Regeneron Core Technology Patents and the Regeneron Core
Technology Know-How, to perform activities under a Development Plan and Budget
and to Exploit the Collaboration Products in the Field in the Territory, which
license shall be (a) if neither Party exercises its Opt-Out Right,
payment-bearing pursuant to Section 7.1 during the Term and (b) if Regeneron
exercises its Opt-Out Right, royalty-bearing pursuant to Section 7.2.1 during
the Royalty Term with respect to each Collaboration Product in each country in
the Territory, and after the expiration of the Royalty Term for a Collaboration
Product in a country shall convert to a fully paid-up, irrevocable, perpetual,
non-exclusive license, with the right to grant sublicenses through multiple
tiers of sublicensees, for such Collaboration Product in such country;
6.1.3    subject to Section 6.4.3, for so long as Alnylam does not exercise its
Opt-Out Right, an exclusive (including with regard to Regeneron and its
Affiliates), non-transferable (except as permitted by Section 13.2), fully
paid-up, worldwide license and right of reference, with the right to grant
sublicenses and further rights of reference in accordance with Section 6.3,
under the Regulatory Approvals and any other Regulatory Documentation that
Regeneron or its Affiliates may Control that are related to a Collaboration
Product as necessary for purposes of performing any activities under a
Development Plan and Budget and for Exploiting such Collaboration Product in the
Field in the Territory;

21 Note to Draft: If Alnylam is the initial Lead Party, then use this
Alternative Section 6.1 in lieu of Section 6.1 above.

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6.1.4    for so long as Alnylam does not exercise its Opt-Out Right, a
non-exclusive license, with the right to grant sublicenses in accordance with
Section 6.3, to use Regeneron’s Corporate Names solely as required to comply
with, and in accordance with, Section 4.8, and for no other purpose; and
6.1.5    a non-exclusive, non-transferable (except as permitted by
Section 13.2), fully paid-up, perpetual, worldwide license (or sublicense), with
the right to grant sublicenses through multiple tiers, under the [***] to
Exploit any product in the Territory containing siRNA (other than a Competing
Product).
Notwithstanding the foregoing in this Section 6.1, Alnylam does not receive any
rights under the license grants in this Section 6.1 to or for any Proprietary
Unlicensed Component of a Combination Product Controlled by Regeneron (or any of
its Affiliates).
6.2    [Grants to Alnylam.]22 
6.2.1    Subject to the terms and conditions of this Agreement, Regeneron hereby
grants Alnylam:
(a)    a non-exclusive, non-transferable (except as permitted by Section 13.2),
fully paid-up, worldwide license (or sublicense), with the right to grant
sublicenses in accordance with Section 6.3, under the Regeneron Technology, to
Develop the Collaboration Products solely for purposes of performing Alnylam’s
obligations as set forth in, and subject to, each applicable Development Plan
and Budget and to Manufacture and supply the Early Stage Supply Requirements,
and if applicable, the Late Stage Supply Requirements; and
(b)    a non-exclusive, non-transferable (except as permitted by Section 13.2),
fully paid-up, perpetual, worldwide license (or sublicense), with the right to
grant sublicenses through multiple tiers, under the [***] to Exploit any product
in the Territory containing siRNA (other than a Competing Product).
6.2.2    If Regeneron exercises its Opt-Out Right, subject to the terms and
conditions of this Agreement, Regeneron shall grant Alnylam:

22 Note to Draft: If Alnylam is the initial Lead Party, then this Section 6.2
should be replaced with the Alternative Section 6.2 set forth at the end of this
Section 6.2.

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(a)    subject to Section 6.4.2, an exclusive (including with regard to
Regeneron and its Affiliates), non-transferable (except as permitted by
Section 13.2), worldwide license (or sublicense), with the right to grant
sublicenses in accordance with Section 6.3, under the Regeneron Product-Specific
Patents and the Regeneron Product-Specific Know-How, to Exploit the
Collaboration Products in the Field in the Territory, which license shall be
royalty-bearing pursuant to Section 7.2.1 during the Royalty Term with respect
to each Collaboration Product in each country in the Territory, and after the
expiration of the Royalty Term for a Collaboration Product in a country shall
convert to a fully paid-up, irrevocable, perpetual, non-exclusive license, with
the right to grant sublicenses through multiple tiers of sublicensees, for such
Collaboration Product in such country;
(b)    a non-exclusive, non-transferable (except as permitted by Section 13.2),
worldwide license (or sublicense), with the right to grant sublicenses in
accordance with Section 6.3, under the Regeneron Core Technology Patents and the
Regeneron Core Technology Know-How, to Exploit the Collaboration Products in the
Field in the Territory, which license shall be royalty-bearing pursuant to
Section 7.2.1 during the Royalty Term with respect to each Collaboration Product
in each country in the Territory, and after the expiration of the Royalty Term
for a Collaboration Product in a country shall convert to a fully paid-up,
irrevocable, perpetual, non-exclusive license, with the right to grant
sublicenses through multiple tiers of sublicensees, for such Collaboration
Product in such country; and
(c)    a non-exclusive license, with the right to grant sublicenses in
accordance with Section 6.3, to use Regeneron’s Corporate Names solely as
required to comply with, and in accordance with, Section 4.8, and for no other
purpose.
Notwithstanding the foregoing in this Section 6.2, Alnylam does not receive any
rights under the license grants in this Section 6.2 to or for any Proprietary
Unlicensed Component of a Combination Product controlled by Regeneron (or any of
its Affiliates).
6.2    [ALTERNATIVE SECTION 6.2] [Grants to Regeneron.]23 
6.2.1    Subject to the terms and conditions of this Agreement, Alnylam hereby
grants Regeneron:

23 Note to Draft: If Alnylam is the initial Lead Party, then use this
Alternative Section 6.2 in lieu of Section 6.2 above.

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(a)    a non-exclusive, non-transferable (except as permitted by Section 13.2),
fully paid-up, worldwide license (or sublicense), with the right to grant
sublicenses in accordance with Section 6.3, under the Alnylam Technology, to
Develop the Collaboration Products solely for purposes of performing Regeneron’s
obligations as set forth in, and subject to, each applicable Development Plan
and Budget; and
(b)    a non-exclusive, non-transferable (except as permitted by Section 13.2),
fully paid-up, perpetual, worldwide license (or sublicense), with the right to
grant sublicenses through multiple tiers, under the [***] to Exploit any product
in the Territory that does not contain any siRNA, MicroRNA, MicroRNA antagonist
or MicroRNA Mimic, or any single or double-stranded oligonucleotide designed to
specifically hybridize to RNA and modulate the expression of the intended
target.
6.2.2    If Alnylam exercises its Opt-Out Right, subject to the terms and
conditions of this Agreement, Alnylam shall grant Regeneron:
(a)    subject to Section 6.4.2, an exclusive (including with regard to Alnylam
and its Affiliates), non-transferable (except as permitted by Section 13.2),
worldwide license (or sublicense), with the right to grant sublicenses in
accordance with Section 6.3, under the Alnylam Product-Specific Patents and the
Alnylam Product-Specific Know-How, to Exploit the Collaboration Products in the
Field in the Territory, which license shall be royalty-bearing pursuant to
Section 7.2.1 during the Royalty Term with respect to each Collaboration Product
in each country in the Territory, and after the expiration of the Royalty Term
for a Collaboration Product in a country shall convert to a fully paid-up,
irrevocable, perpetual, non-exclusive license, with the right to grant
sublicenses through multiple tiers of sublicensees, for such Collaboration
Product in such country;
(b)    a non-exclusive, non-transferable (except as permitted by Section 13.2),
worldwide license (or sublicense), with the right to grant sublicenses in
accordance with Section 6.3, under the Alnylam Core Technology Patents and the
Alnylam Core Technology Know-How, to Exploit the Collaboration Products in the
Field in the Territory, which license shall be royalty-bearing pursuant to
Section 7.2.1 during the Royalty Term with respect to each Collaboration Product
in each country in the Territory, and after the expiration of the Royalty Term
for a Collaboration Product in a country shall convert to a fully paid-up,
irrevocable, perpetual, non-exclusive license, with the right to grant
sublicenses through multiple tiers of sublicensees, for such Collaboration
Product in such country; and
(c)    a non-exclusive license, with the right to grant sublicenses in
accordance with Section 6.3, to use Alnylam’s Corporate Names solely as required
to comply with, and in accordance with, Section 4.8, and for no other purpose.

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Notwithstanding the foregoing in this Section 6.2, Regeneron does not receive
any rights under the license grants in this Section 6.2 to or for any
Proprietary Unlicensed Component of a Combination Product Controlled by Alnylam
(or any of its Affiliates).
6.3    Sublicenses. Either Party shall have the right to grant sublicenses (or
further rights of reference), through multiple tiers, under the licenses and
rights of reference granted to [Regeneron]24 in Section 6.1.1, Section 6.1.2,
Section 6.1.3 or Section 6.1.4 or to [Alnylam]25 in Section 6.2.1(a) or
Section 6.2.2, as applicable; provided that any such sublicenses to Develop or
Commercialize a Collaboration Product shall be consistent with the terms and
conditions of this Agreement and shall contain terms and conditions consistent
with those in this Agreement and (a) if neither Party has exercised its Opt-Out
Right, any such sublicense agreements shall first be approved by the Joint
Steering Committee pursuant to Section 2.1.2(j); or (b) if a Party has exercised
its Opt-Out Right, any such sublicense agreements with respect to the United
States by the Lead Party shall first be approved by the Participating Party,
such approval not to be unreasonably withheld, conditioned or delayed; provided,
however, that in either case ((a) or (b)), if any such sublicense agreement is
between either Party and one or more of such Party’s Affiliates, then no prior
approval is required. If a Party has exercised its Opt-Out Right, the Lead Party
will promptly provide the other Party with a copy of any fully executed
sublicense agreement with a Third Party covering any Commercialization
sublicense outside the United States granted hereunder. Each such sublicense
agreement entered into by a Party (whether before or after a Party has exercised
its Opt-Out Right) shall contain a requirement that the Sublicensee comply with
confidentiality and non-use provisions that are no less stringent than
Section 9.1 with respect to the other Party’s Confidential Information.
Furthermore, the applicable Party shall use commercially reasonable efforts to
ensure that, to the extent possible, each such sublicense agreement by it to a
Sublicensee provides that any and all data and results, discoveries, inventions
and other Information, whether patentable or not, arising out of the sublicense
are owned by such Party or one of its Affiliates; provided that if, after using
commercially reasonable efforts, the foregoing is not possible, then such Party
shall ensure that it sufficiently Controls all such data and results,
discoveries, inventions and other Information in order to grant the licenses to
the other Party as contemplated under this Agreement. Notwithstanding any
sublicense to a Sublicensee, the sublicensing Party shall remain responsible to
the other Party for the performance of all of the sublicensing Party’s
obligations under, and compliance with, all applicable terms and conditions of,
this Agreement, including any obligations delegated to its Sublicensees. For the
avoidance of doubt, either Party may grant sublicenses, through multiple tiers,
under the licenses granted to such Party under Section 6.1.5 or
Section 6.2.1(b), as applicable, without the consent of the other Party and the
foregoing provisions of this Section 6.3 shall not apply to such sublicenses.
24 Note to Draft: Change to “Alnylam” if Alnylam is the initial Lead Party.
25 Note to Draft: Change to “Regeneron” if Alnylam is the initial Lead Party.

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6.4    No Implied License; Retention of Rights.
6.4.1    Except as expressly provided herein, nothing in this Agreement grants
either Party or vests in either Party any right, title or interest in and to the
Information, Patent Rights, Confidential Information, Trademarks or other
intellectual property of the other Party (either expressly or by implication or
estoppel), other than the license rights expressly granted hereunder and the
assignments expressly made hereunder.
6.4.2    Notwithstanding anything to the contrary in this Agreement, and without
limiting any rights granted or reserved to Regeneron pursuant to any other term
or condition of this Agreement:
(a)    Regeneron hereby expressly retains, on behalf of itself and its
Affiliates (and on behalf of its licensors, (sub)licensees and contractors) all
right, title and interest in and to the Regeneron Technology to (i) perform its
and their obligations under this Agreement, including to perform all activities
under each Development Plan and Budget; and (ii) subject to Section 6.7,
develop, obtain and maintain regulatory approvals for, and to manufacture,
commercialize, and otherwise exploit any compound or product, other than a
Collaboration Product, in any field anywhere in the world; and
(b)    Regeneron reserves the right to grant the licenses to Third Parties for
the purposes described in Section 6.7.3.
6.4.3    Notwithstanding anything to the contrary in this Agreement, and without
limiting any rights granted or reserved to Alnylam pursuant to any other term or
condition of this Agreement, Alnylam hereby expressly retains, on behalf of
itself and its Affiliates (and on behalf of its licensors, (sub)licensees and
contractors) all right, title and interest in and to the Alnylam Technology to
(a) perform its and their obligations under this Agreement, including (i) to
perform all activities under each Development Plan and Budget, (ii) to
Manufacture and supply the Early Stage Supply Requirements and if applicable,
the Late Stage Supply Requirements and (b) subject to Section 6.7, develop,
obtain and maintain regulatory approvals for, and to manufacture, commercialize,
and otherwise exploit any compound or product, other than a Collaboration
Product, in any field anywhere in the world.
6.4.4    [***]

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6.5    In-License Agreements.
6.5.1    Entry Into In-Licenses.
[***]
6.5.2    Additional Alnylam In-Licenses. In the event that a Patent Right
licensed to Alnylam under an Additional Alnylam In-License actually is or will
be infringed by Regeneron’s Development, Manufacture or Commercialization of a
Collaboration Product in the Field and in the Territory in accordance with this
Agreement, then such Additional Alnylam In-License will thereafter automatically
be deemed to be an Existing Alnylam In-License on a Collaboration
Product-by-Collaboration Product basis, and all rights granted to Alnylam
thereunder will be deemed to be “Controlled” by Alnylam and sublicensed to
Regeneron under the applicable terms of Section [6.1]26, effective as of the
later of (a) the date the applicable Patent Right issues and (b) the date that
Regeneron’s Development, Manufacture or Commercialization of such Collaboration
Product in the Field and in the Territory in accordance with this Agreement
under the applicable terms of Section [6.1]27 would infringe such Patent Right
in the absence of a license thereunder from Alnylam; provided, for clarity, that
the performance of activities as permitted under the safe harbor provision
provided in 35 U.S.C. § 271(e)(1) (or other applicable safe harbor exemptions in
other countries outside the United States) shall not be deemed to trigger the
date under the foregoing clause (b).
6.5.3    Management of In-Licenses. Neither Party shall, and each Party shall
cause its Affiliates not to, enter into any subsequent agreement or
understanding with any Third Party to an In-License to which such Party or any
of its Affiliates is a party that modifies, amends or terminates any such
In-License, or waives any right or obligation thereunder, in any way that would
adversely affect in any material respect the other Party’s rights or interests
under this Agreement, including by increasing any of the other Party’s
obligations or otherwise agreeing to any covenants or obligations imposed on the
other Party that would adversely impact the other Party’s business outside of
this Agreement, in each case, without the other Party’s prior written consent,
not to be unreasonably withheld, conditioned or delayed. Neither Party shall,
and each Party shall cause its Affiliates not to, commit any acts or permit the
occurrence of any omissions that would cause a material breach or termination of
any such In-License that would adversely affect in any material respect the
other Party’s rights or interests under this Agreement.

26 Change reference to Section 6.2 if Alnylam is the initial Lead Party.
27 Change reference to Section 6.2 if Alnylam is the initial Lead Party.

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6.5.4    In-Licenses. Each Party acknowledges and agrees that the sublicenses
and other rights granted by the other Party to such first Party in this
Agreement are subject to the terms of any In-Licenses to which such other Party
or any of its Affiliates is a party. Each Party granted a sublicense pursuant to
this Agreement under any of the In-Licenses of the other Party (or any of its
Affiliates) (the Party granted a sublicense, the “Sublicensed Party,” and the
Party granting the sublicense, the “Sublicensor Party”) shall comply with, and
perform and take such actions as may be required to allow the Sublicensor Party
to comply with, all applicable terms and conditions of the In-Licenses of the
Sublicensor Party to the extent (a) applicable to (i) the Sublicensed Party’s
rights or obligations relating to the Development, Manufacture or
Commercialization of Collaboration Products under this Agreement or (ii) the
filing, prosecution, maintenance, extension, defense, enforcement or the further
sublicensing of the Alnylam Technology (if Alnylam is the Sublicensor Party) or
the Regeneron Technology (if Regeneron is the Sublicensor Party) to the extent
relevant to the Sublicensed Party’s rights or obligations relating to the
Development, Manufacture or Commercialization of Collaboration Products under
this Agreement, and (b) the Sublicensed Party has been given written notice or
provided a copy of such terms and conditions on or before the later of (i) the
Effective Date and (ii) the date on which such In-License is first required to
have been provided to the Sublicensed Party hereunder, including any such terms
and conditions relating to sublicensing, patent matters, confidentiality,
reporting, audit rights, indemnification and diligence. Without limiting the
foregoing, (x) the Parties shall, from time to time, upon the reasonable request
of either Party, discuss the terms of any In-License and (y) each Sublicensed
Party shall prepare and deliver to the Sublicensor Party any reports required
under the applicable In-Licenses of the Sublicensor Party sufficiently in
advance to enable the Sublicensor Party to comply with its obligations under the
applicable In-Licenses, to the extent that the Sublicensed Party had been made
aware of such provisions sufficiently in advance of the date on which such
compliance is required in order for such Sublicensed Party to properly prepare
such reports.
6.5.1    Excluded Agreements. Notwithstanding anything herein to the contrary,
Regeneron acknowledges that certain Patent Rights and Information under which
Alnylam has rights are in-licensed by Alnylam under the Excluded Agreements. It
is understood and agreed that no sublicense is granted to Regeneron by Alnylam
under the Excluded Agreements pursuant to this Agreement, and that no Patent
Rights or Information licensed to Alnylam under the Excluded Agreements will be
Controlled by Alnylam under this Agreement. Alnylam shall be solely responsible
for, and shall solely bear, all costs arising under or in connection with any
Excluded Agreement.
6.6    Confirmatory Patent License. Each Party shall, if requested to do so by
the other Party, promptly enter into confirmatory license agreements in the form
or substantially the form

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reasonably requested by such other Party for purposes of recording the licenses
granted under this Agreement with such patent offices in the Territory as the
requesting Party considers appropriate. Until the execution of any such
confirmatory licenses, so far as may be legally possible, Alnylam and Regeneron
shall have the same rights in respect of the respective intellectual property
and be under the same obligations to each other in all respects as if the said
confirmatory licenses had been executed.
6.7    Exclusivity.
6.7.1    Exclusivity.
(a)    Target Exclusivity. Regardless of whether either Party exercises its
Opt-Out Right, during the Term, subject to Section 6.7.2 and Section 6.7.3 and
the remainder of this Section 6.7.1(a), and in the case of Alnylam, except as
and to the extent set forth in the Existing Alnylam Third Party Agreements and
in the case of Regeneron except as and to the extent set forth in the Existing
Regeneron Third Party Agreements, in each case, as existing as of the Effective
Date (as defined in the Master Agreement) of the Master Agreement, each Party
shall not, and shall cause its Affiliates not to, (i) directly or indirectly,
develop, commercialize or manufacture for purposes of development or
commercialization, any Competing Product in the Field in any country in the
Territory, or (ii) license, authorize or appoint any Third Party to directly or
indirectly, develop, commercialize or manufacture for purposes of development or
commercialization, any Competing Product in the Field in any country in the
Territory.
(A)    The provisions of Section 6.7.1(a)(i) and (ii) shall not apply to any
Competing Product Directed to the Target using or incorporating only
Non-Relevant Organ Delivery Technology; provided that such Competing Product
using or incorporating such Non-Relevant Organ Delivery Technology is not
administered to or used in (or developed or designed for use or administration
in) the Relevant Organ through any route of administration [(including when
administered intrathecally)]28.
(B)    [The provisions of Section 6.7.1(a)(i) and (ii) shall not apply to any
Permitted Competing Products.]29 
28 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
29 Note to Draft: Include this bracketed provision only if the Target was a CNS
Target under the Master Agreement and there is a Permitted Competing Product
hereunder.

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(b)    siRNA Sequence Exclusivity. Without limiting the provisions of Section
6.7.1(a), during the Term, Alnylam shall not, and shall cause its Affiliates not
to, (i) directly or indirectly, develop, commercialize or manufacture for
purposes of development or commercialization any siRNA that includes the same
nucleotide sequence (or a different nucleotide sequence that functionally
targets the same nucleotide sequence of the messenger RNA) as a Collaboration
Product except [***] (ii) license, authorize or appoint any Third Party to
directly or indirectly, develop, commercialize or manufacture for purposes of
development or commercialization any siRNA that includes the same nucleotide
sequence (or a different nucleotide sequence that functionally targets the same
nucleotide sequence of the messenger RNA) as a Collaboration Product except for
[***]; provided that in each case ((i)-(ii)), [***].
(c)    Continuation from Master Agreement. In the event that prior to entering
into this Agreement there was a “Competing Program” or “Acquisition Product”
with respect to the Target pursuant to Section 5.7.2 of the Master Agreement,
then such “Competing Program” or “Acquisition Product” shall also be a Competing
Program or Acquisition Product, as applicable, for purposes of this Agreement,
and the provisions of Sections 6.7.2 and 6.7.3 shall apply; provided, however,
that if the applicable Acquirer and its Affiliates (other than Pre-Existing
Affiliates) was allowed to continue to develop, manufacture, commercialize and
exploit a given Competing Program under the Master Agreement in accordance with
Section 5.7.2(d) of the Master Agreement, then such Acquirer and its Affiliates
(other than Pre-Existing Affiliates) shall have the right to continue to
develop, manufacture, commercialize and exploit such Competing Program hereunder
without being in violation of the provisions of Section 6.7.1(a); provided that
the Acquirer shall or shall cause the Acquired Party to (i) continue to fulfill
its obligations under this Agreement in all respects, (ii) ensure that the
conduct of Competing Program activities is completely independent of the
activities conducted under or in connection with this Agreement, (iii) ensure
that all Competing Program activities (A) do not use, access or incorporate and
are not based on any Alnylam Know-How, Regeneron Know-How or other Confidential
Information, for so long as such Confidential Information remains subject to the
confidentiality and non-use obligations under Section 9.1, and (B) are not
covered by and do not incorporate or reference the Alnylam Patents or Regeneron
Patents (or any Information or inventions disclosed in any of the foregoing),
and (iv) establish reasonable internal safeguards designed to prevent any
Alnylam Know-How, Regeneron Know-How or other Confidential Information from
being disclosed to, or otherwise utilized by, the Acquirer or any of its
Affiliates (other than Pre-Existing Affiliates), in connection with the
Competing Program, for so long as such Confidential Information remains subject
to the confidentiality and non-use obligations under Section 9.1.

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6.7.2    Change of Control and Acquired Competing Programs and Products.
(a)    If, during the Term, (i) there is a Change of Control of a Party (such
Party, the “Acquired Party”) and as of the effective date of such Change of
Control, a Third Party described in the definition of “Change of Control” or any
of its Affiliates (other than the Acquired Party, or the Acquired Party’s
Pre-Existing Affiliates) (the “Acquirer”) is engaged, directly or indirectly, in
any activities that, if carried out by the Acquired Party, would be a breach of
the exclusivity obligations set forth in Section 6.7.1 (such activities, a
“Competing Program”), or (ii) as the result of an acquisition of a Third Party
or the assets of a Third Party by a Party or one or more of its Affiliates (the
“Acquiring Party”), the Acquiring Party directly or indirectly acquires rights
to a Competing Product in the Field that would be a breach of the exclusivity
obligations set forth in Section 6.7.1 (each such Competing Product, an
“Acquisition Product” and each transaction described in subsection (i) or (ii),
a “Third Party Acquisition”); then, the Acquired Party or Acquiring Party, as
applicable, shall give the other Party (the “Non-Acquiring Party”) express
written notice thereof within ten (10) Business Days after the closing of such
Third Party Acquisition and furthermore the Acquired Party or Acquiring Party,
as applicable, shall in its sole discretion do one of the following after the
closing of such Third Party Acquisition: (w) by the later of six (6) months
after (i) such closing, (ii) the expiration of the Divestment Period pursuant to
Section 6.7.2(b) and (iii) the date on which the Parties cease negotiations
pursuant to Section 6.7.2(c), as applicable, terminate all development,
commercialization and manufacture for purposes of development or
commercialization, with respect to such Competing Program or Acquisition
Product, as applicable (other than Clinical Trials that a Regulatory Authority
requires the Acquired Party or Acquiring Party, as applicable, to continue,
which may be continued for no more than twelve (12) months after such closing or
such longer period as such Regulatory Authority requires), and deliver to the
Non-Acquiring Party a notice of such termination, which notice shall include a
covenant that no further development, commercialization or manufacture for
purposes of development or commercialization, with respect to such Competing
Program or Acquisition Product shall be performed by or on behalf of such
Acquired Party or Acquiring Party, as applicable, or any of its Affiliates, to
the extent the provisions of Section 6.7.1 would have prohibited such
activities; provided, that an Acquired Party or Acquiring Party, as applicable,
shall not be prohibited from later divesting its rights in such terminated
Competing Program or Acquisition Product, as applicable, whether pursuant to the
provisions of this Section 6.7.2 or otherwise; (x) divest its rights in the
Competing Program or Acquisition Product to a Third Party pursuant to
Section 6.7.2(b); (y) offer the Competing Product Option to the Non-Acquiring
Party pursuant to Section 6.7.2(c) or (z) if applicable, exercise the right to
continue the Competing Program as set forth in Section 6.7.2(d). If the Acquired
Party or Acquiring Party fails to comply with one of the foregoing clauses (w),
(x), (y) or (z), then, unless the Parties otherwise agree in writing, the
Acquired Party or Acquiring Party, as applicable, shall be in breach of
Section 6.7.1.

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(b)    If the Acquired Party or Acquiring Party, as applicable, chooses to
divest its rights in the Competing Program or Acquisition Product, as
applicable, to a Third Party, the Acquired Party or Acquiring Party, as
applicable, shall commit in writing to the Non-Acquiring Party, within
forty-five (45) days of the later of (i) the closing of such Third Party
Acquisition and (ii) the date on which the Parties cease negotiations pursuant
to Section 6.7.2(c), as applicable, to divest such Competing Program or
Acquisition Product, as applicable, to a Third Party within one hundred
eighty (180) days after the closing of the Third Party Acquisition, and shall do
so within such one hundred eighty (180)-day period; provided, that if the
Acquired Party or Acquiring Party, as applicable, fails to complete such
divestiture within such one hundred eighty (180)-day period, but can demonstrate
to the Non-Acquiring Party’s reasonable satisfaction that it used commercially
reasonable efforts to effect such divestiture within such one hundred
eighty (180)-day period, then, unless otherwise required by Applicable Law, such
one hundred eighty (180)-day period shall be extended for such additional
reasonable period thereafter as is necessary to enable such Competing Program or
Acquisition Product, as applicable, to be in fact divested, not to exceed an
additional one hundred and eighty (180) days; provided, however, that such
period shall be extended for such period as is necessary to obtain any
governmental or regulatory approvals required to complete such divestiture,
provided that the Acquired Party or Acquiring Party, as applicable, is using
good faith efforts to obtain such approvals (such period, the “Divestment
Period”). If the Acquired Party or Acquiring Party, as applicable, does not
complete the divestiture within the Divestment Period, then the Acquired Party
or Acquiring Party, as applicable, shall terminate such Competing Program or
Acquisition Product, as applicable pursuant to Section 6.7.2(a), or, provided
such Competing Program or Acquisition Product has not previously been the
subject of a Competing Product Option, offer the Non-Acquiring Party the option
to include the Competing Program or Acquisition Product as a Collaboration
Product under this Agreement pursuant to Section 6.7.2(c). Any divestiture of
rights under this Section 6.7.2(b) shall not permit the Acquired Party or
Acquiring Party, as applicable, or its Affiliates to retain any rights in (other
than the right to receive payments) or involvement with the Competing Program or
Acquisition Product, as applicable, including rights to direct or influence the
course of development or commercialization thereof, or to contribute or receive
nonpublic know-how or information of any sort with respect thereto (other than
reports showing the basis for calculating payments made to the Acquired Party or
Acquiring Party, as applicable, and the right to audit the accuracy of such
reports); provided, that the Acquired Party or Acquiring Party, as applicable,
may continue to supply the applicable Competing Product to the acquirer and
provide other transitional services for a reasonable transitional period until
the acquirer is able to establish its own source of supply of such Competing
Product and provider for such services. If the Acquired Party or Acquiring
Party, as applicable, elects to divest the Competing Program or Acquisition
Product, the Acquired Party or Acquiring Party, as applicable shall not be
precluded under Section 6.7.1 from conducting any activities (either directly,
or with or through any Third Party) with respect to such Competing Program or
Acquisition Product during the applicable Divestment Period; provided, that any
such activities are subject to appropriate firewall

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procedures to segregate such activities (and the personnel conducting such
activities) from the activities performed by or on behalf of the Acquired Party
or Acquiring Party, as applicable, pursuant to this Agreement to ensure that no
Confidential Information of the Non-Acquiring Party and no other information
generated under this Agreement is used in connection with such Competing Program
or Acquisition Product.
(c)    If the Acquired Party or Acquiring Party, as applicable, chooses to offer
to the Non-Acquiring Party the option to include the Competing Program or
Acquisition Product as a Collaboration Product under this Agreement (the
“Competing Product Option”), the Acquired Party or Acquiring Party, as
applicable, shall provide a Competing Product Option Data Package to the
Non-Acquiring Party within thirty (30) days after the closing of such Third
Party Acquisition. If the Non-Acquiring Party is interested, in its sole
discretion, in exercising the Competing Product Option, it shall provide written
notice thereof to the Acquired Party or Acquiring Party, as applicable, within
thirty (30) days of receipt of the Competing Product Option Data Package and,
promptly thereafter, the Parties shall negotiate in good faith the terms
pursuant to which such Competing Program or Acquisition Product would be
included as a Collaboration Product under this Agreement. If the Parties do not
reach agreement within ninety (90) days after beginning such good faith
negotiations, then the Acquired Party or Acquiring Party, as applicable, shall
either terminate such Competing Program or Acquisition Product or divest its
rights in such Competing Program or Acquisition Product pursuant to this
Section 6.7.2.
(d)    Notwithstanding anything in this Section 6.7.2 to the contrary, if during
the Term there is a Third Party Acquisition as described in Section 6.7.2(a)(i)
and either Party has previously exercised its Opt-Out Right or the Acquired
Party exercises its Opt-Out Right pursuant to Section 3.5.5, then the Acquirer
and its Affiliates (other than Pre-Existing Affiliates) shall have the right to
continue to develop, manufacture, commercialize and exploit such Competing
Program without being in violation of the provisions of Section 6.7.1(a) (or the
provisions of Section 6.7.1(b), but with respect to Section 6.7.1(b), this
Section 6.7.2(d) shall only apply [***]; provided that the Acquirer shall or
shall cause the Acquired Party to (i) continue to fulfill its obligations under
this Agreement in all respects, (ii) ensure that the conduct of Competing
Program activities is completely independent of the activities conducted under
or in connection with this Agreement, (iii) ensure that all Competing Program
activities (A) do not use, access or incorporate and are not based on any
Alnylam Know-How, Regeneron Know-How or other Confidential Information, for so
long as such Confidential Information remains subject to the confidentiality and
non-use obligations under Section 9.1, and (B) are not covered by and do not
incorporate or reference the Alnylam Patents or Regeneron Patents (or any
Information or inventions disclosed in any of the foregoing), and (iv) establish
reasonable internal safeguards designed to prevent any Alnylam Know-How,
Regeneron Know-How or other Confidential Information from being disclosed to, or
otherwise utilized by, the Acquirer or any of its Affiliates (other than
Pre-Existing Affiliates), in

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connection with the Competing Program, for so long as such Confidential
Information remains subject to the confidentiality and non-use obligations under
Section 9.1.
(e)    Notwithstanding anything in this Agreement to the contrary, following the
closing of a Change of Control of an Acquired Party, the Parties agree that (x)
the Non-Acquiring Party shall not obtain rights or access to the Patent Rights
or Information controlled by the Acquirer or any of the Affiliates of such
Acquirer (other than the Acquired Party and its Affiliates that exist
immediately prior to the closing of such Change of Control and any successor
thereto (such Affiliates of the Acquired Party, the “Pre-Existing Affiliates”))
at the time of such closing (and improvements to such Patent Rights or
Information) and any other Patent Rights or Information first acquired or
in-licensed by such Acquirer (or any of its Affiliates, other than the Acquired
Party and its Pre-Existing Affiliates) from a Third Party after the closing of
the Change of Control transaction (and improvements thereto) (so that, for
clarity, none of the foregoing in this clause (x) will be treated as Controlled
by Alnylam or any of its Affiliates, or by Regeneron or any of its Affiliates,
as applicable, based on which Party is the Acquired Party), and (y) the Acquirer
and its Affiliates (other than the Acquired Party and its Pre-Existing
Affiliates) shall not obtain rights or access to the Patent Rights or
Information controlled by the Non-Acquiring Party or any of its Affiliates
pursuant to this Agreement, other than in connection with the Exploitation of
any Collaboration Products as provided under this Agreement; provided that
clause (x) of this Section 6.7.2(e) shall not apply to any Patent Rights or
Information controlled by the Acquirer or any of its Affiliates to the extent
such Patent Right or Information (i) is used by or on behalf of the Acquired
Party or any of its Affiliates in performing any of the Acquired Party’s
obligations under this Agreement; (ii) is incorporated into any Collaboration
Product by or on behalf of the Acquired Party or any of its Affiliates; or
(iii) was generated after the closing of such Change of Control through any use
of, or access to, any Alnylam Know-How (with respect to Alnylam as the Acquired
Party) or any Regeneron Know-How (with respect to Regeneron as the Acquired
Party) or is otherwise Covered by any Alnylam Patent (with respect to Alnylam as
the Acquired Party) or any Regeneron Patent (with respect to Regeneron as the
Acquired Party); provided that, (A) with respect to Alnylam as the Acquired
Party, if the Acquirer or any of its Affiliates was party to an agreement with
Alnylam or any Pre-Existing Affiliate on or prior to the date of such Change of
Control pursuant to which the Acquirer or such Affiliates received a license to
any Information or Patent Rights controlled by Alnylam or its Pre-Existing
Affiliates other than any Alnylam Product-Specific Know-How or Alnylam
Product-Specific Patents, then this clause (iii) shall not apply to any Patent
Rights or Information controlled or generated by Acquirer or such Affiliates
under such agreement prior to such Change of Control that were not Controlled by
Alnylam or any Pre-Existing Affiliate or (B) with respect to Regeneron as the
Acquired Party, if the Acquirer or any of its Affiliates was party to an
agreement with Regeneron or any Pre-Existing Affiliate on or prior to the date
of such Change of Control pursuant to which the Acquirer or such Affiliates
received a license to any Information or Patent Rights controlled by Regeneron
or its Pre-Existing Affiliates other than any Regeneron

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Product-Specific Know-How or Regeneron Product-Specific Patents, then this
clause (iii) shall not apply to any Patent Rights or Information controlled or
generated by Acquirer or such Affiliates under such agreement prior to such
Change of Control that were not Controlled by Regeneron or any Pre-Existing
Affiliate. Without limiting the foregoing, in all cases, the Non-Acquiring
Party’s rights in all Patent Rights and Information Controlled by the Acquired
Party or any of its Pre-Existing Affiliates, or any of their respective
successors, and all improvements thereto, shall remain licensed to such
Non-Acquiring Party after the date of the closing of such Change of Control in
accordance with and subject to the terms and conditions of this Agreement and
shall not be affected in any manner by virtue of such Change of Control.
6.7.3    Regeneron Exceptions. Notwithstanding the exclusivity obligation in
Section 6.7.1 or the exclusive license grants contained in [Section 6.2]30:
(a)    Regeneron reserves the right to grant licenses to Third Parties to use
intellectual property owned or otherwise controlled by Regeneron or its
Affiliates related to research-enabling technologies, discovery-enabling
technologies or manufacturing-related technologies, including Regeneron
Technology, and rights to Regeneron Mice, but excluding Alnylam Technology,
Regeneron Product-Specific Patents and Regeneron Product-Specific Know-How
(“Excluded Collaboration Technology”), which licenses during the Term, may be
for general purposes not specific to Competing Products (i.e., that is not
specific to the Manufacture of any particular Competing Product), but which may
involve the exploitation of Competing Products in the Field, and such grant and
any associated disclosure or provision of such intellectual property or
provision of technical assistance using only such intellectual property in
connection therewith shall not constitute a breach of this Agreement (including
Section 6.7.1); provided that Regeneron and its Affiliates will not otherwise
actively assist any Third Party (other than through the grant of such license or
provision of such technical assistance) in developing or commercializing any
Competing Product in the Field if doing so would not comply with Section 6.7.1,
but, for clarity, may receive license fees, milestones and royalties in
connection with exploitation by Third Parties of any Competing Products in the
Field generated by such Third Parties.
30 Note to Draft: Change reference to Section 6.1 if Alnylam is the initial Lead
Party.

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(b)    Regeneron reserves the right to grant licenses to Third Parties to use
any clinical, genomic, and molecular data maintained by the Regeneron Genetics
Center, other than any such data that is Excluded Collaboration Technology, for
any purpose, which may involve activities with respect to Competing Products in
the Field, and such grant and any associated disclosure or provision of such
data or provision of technical assistance without the use of Excluded
Collaboration Technology in connection therewith shall not constitute a breach
of this Agreement (including Section 6.7.1); provided that, Regeneron and its
Affiliates will not otherwise actively assist any Third Party (other than
through the grant of such license or provisions of such technical assistance) in
developing or commercializing any Competing Product in the Field if doing so
would not comply with Section 6.7.1, but, for clarity, may receive license fees,
milestones and royalties in connection with exploitation by Third Parties of any
Competing Products in the Field generated by such Third Parties.
(c)    The Parties acknowledge and agree that nothing in Section 6.7.1 prevents
or limits Regeneron’s or its Affiliate’s rights to (i) settle any enforcement
action or proceeding (including any counterclaim in any such action or
proceeding), declaratory judgment action or similar action or claim, or any
other litigation or proceeding involving an allegation of infringement or other
violation of intellectual property or the invalidity or enforceability of any
Patent Right owned or otherwise controlled by Regeneron or any of its Affiliates
(other than with respect to intellectual property controlled by Regeneron or its
Affiliates as a licensee of Alnylam under this Agreement), including by granting
licenses or other rights under any such Patent Right to Third Parties in
connection therewith or (ii) enter into an agreement to preempt, and thereby
avoid the initiation of, any of the actions, proceedings, claims or other
litigation set forth in clause (i), including by granting licenses or other
rights under any such Patent Right to Third Parties in connection therewith;
provided that, in either case ((i) or (ii)), neither Regeneron nor any of its
Affiliates may grant a license or other right under any such Patent Right to a
Third Party to make, have made, use, offer to sell, sell or import a generic
version of a Collaboration Product in the Field, including any Generic Product,
except pursuant to ARTICLE 8.
ARTICLE 7    
PAYMENTS
7.1    Sharing of Development Costs and Profits. Unless and until a Party
exercises its Opt-Out Right:
7.1.1    Sharing.
(a)    Subject to Sections 7.1.1(b) and 7.1.1(c), commencing on the Effective
Date and continuing during the Term, the Parties shall share Profits and
Development Costs equally (50%/50%) for all Collaboration Products as described
in Schedule 7.1.1.

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(b)    Notwithstanding the provisions of Section 7.1.1(a), the following shall
apply:
(i)    in the event that a Collaboration Product is a Combination Product that
includes a Proprietary Unlicensed Component, then the Parties will not share in
any revenues from the Proprietary Unlicensed Component and such revenues shall
be solely for the benefit of the Party who has the applicable Proprietary
Unlicensed Component (provided that with respect to Net Sales, the Parties agree
that such allocation shall be in accordance with the definition of Net Sales),
and the Parties shall in good faith reasonably allocate and share in accordance
with the terms of this Agreement the revenues attributable to the Collaboration
Product other than the Proprietary Unlicensed Component of such Collaboration
Product; and
(ii)    in the event that a Proprietary Unlicensed Component is administered in
a Clinical Trial of Collaboration Product hereunder, then [***].
(c)    Notwithstanding the provisions of Section 7.1.1(a), solely with respect
to the Ongoing Candidate Discovery Development Activities, the Party that is
responsible for performing such activities (as set forth in the Pre-Clinical
Plan and Budget) shall be solely responsible for the costs thereof, and such
costs shall not be included as Development Costs hereunder and shall not be
shared by the Parties.
7.1.2    Payments.
(a)    The Parties shall make Quarterly Development True-Up and Quarterly Profit
True-Up payments as set forth in Schedule 7.1.1. If the Lead Party is the Party
owing Quarterly Development True-Up or Quarterly Profit True-Up payment(s) based
on the calculations in the applicable Development Payment Report or Profit
Payment Report, it shall, subject to Section 7.1.4 and Section 7.7, make such
payment to the Participating Party within ten (10) days after its delivery to
the Participating Party of such Development Payment Report pursuant to
Section 7.1.3(f) or Profit Payment Report pursuant to Section 7.1.3(g), as
applicable and receipt of an invoice therefor from the Participating Party. If
the Participating Party is the Party owing the Quarterly Development True-Up or
Quarterly Profit True-Up payment(s) based on the calculations in the applicable
Development Payment Report pursuant to Section 7.1.3(f) or Profit Payment Report
pursuant to Section 7.1.3(g), it shall, subject to Section 7.1.4 and
Section 7.7, make such payment to the Lead Party within ten (10) days after its
receipt of such Development Payment Report pursuant to Section 7.1.3(f) or
Profit Payment Report pursuant to Section 7.1.3(g), as applicable, from the Lead
Party and receipt of an invoice therefor from the Lead Party.
(b)    If agreed between the Parties, the Parties may also net the collective
payment(s) due under the Development Payment Report and Profit Payment Report.
In the event that In-License Payments payable under an In-License are payable on
a schedule other than the

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schedule set forth in this Agreement for Quarterly Development True-Up or
Quarterly Profit True-Up payment(s), the Parties shall discuss in good faith an
appropriate schedule upon which the Party that is not party to such In-License
shall make such payment to the other Party or its designee, and the Parties
shall adjust the amounts payable for the next Quarterly Development True-Up or
Quarterly Profit True-Up payment(s) accordingly to credit such paying Party for
its pre-payment of any such amounts.
7.1.3    Periodic Financial Reports. Each Party shall prepare and deliver to the
other Party the applicable periodic reports specified below:
(a)    Within [***] days following the end of each month for the first [***]
months of every Calendar Quarter (and for clarity, not for the final month of
each Calendar Quarter) commencing with the Calendar Quarter in which the First
Commercial Sale of any Collaboration Product occurs in any country in the world,
the Lead Party shall provide to the Participating Party a written monthly
detailed Net Sales report (in electronic form), in each case with monthly and
year-to-date sales in local currency and in each country in which such
Collaboration Product is sold, such reporting obligation to commence with the
month in which the First Commercial Sale of any Collaboration Product occurs in
any country;
(b)    Within [***] days after the end of each Calendar Quarter during which a
Party performs any Development activities under a Development Plan and Budget,
each Party shall provide to the other Party a written report (in electronic
form) summarizing the material activities undertaken by such Party during such
Calendar Quarter in connection with each Development Plan and Budget, together
with a statement of Development Costs and Excess Development Costs incurred by
such Party during such Calendar Quarter, which statement shall, with respect to
the Development Costs (but, for clarity, not the Excess Development Costs),
detail those amounts to be included in the Development Payment Report for such
Calendar Quarter. Each Party shall also submit an estimate of the Development
Costs and Excess Development Costs incurred by such Party to the other Party
within [***] days after the end of such Calendar Quarter;
(c)    Within [***] days following the end of each Calendar Quarter, commencing
with the Calendar Quarter in which the First Commercial Sale of any
Collaboration Product occurs in any country in the world, the Lead Party shall
provide to the Participating Party a written report (in electronic form) setting
forth, on a country-by-country basis for such Calendar Quarter, for each
country, (i) the Net Sales of each Collaboration Product in local currency and
in Dollars, (ii) Collaboration Product quantities sold and (iii) gross
Collaboration Product sales and an accounting of the deductions from gross sales
permitted by the definition of Net Sales. The Lead Party shall also submit an
estimate of the foregoing to the Participating Party within [***] days after the
end of such Calendar Quarter;

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(d)    Within [***] days following the end of each Calendar Quarter, each Party
that has incurred any Other Shared Expenses, Shared Commercial Expenses or Cost
of Goods Sold in that Calendar Quarter shall provide to the other Party a
written report (in electronic form) setting forth in reasonable detail the Other
Shared Expenses, Shared Commercial Expenses or Cost of Goods Sold incurred by or
on behalf of such Party in such Calendar Quarter in the aggregate on a worldwide
basis and also on a Major Market Country-by-Major Market Country basis, in local
currency and in Dollars. Each Party shall also submit an estimate of the
foregoing to the other Party within [***] days after the end of such Calendar
Quarter;
(e)    Within [***] days following the end of each Calendar Quarter in which the
Lead Party receives Third Party Transaction Proceeds, the Lead Party shall
provide to the Participating Party a written report (in electronic form) in
respect of such Calendar Quarter, providing information regarding the amount of
Third Party Transaction Proceeds and the identity of the Third Party. The Lead
Party shall also submit an estimate of the foregoing to the Participating Party
within [***] days after the end of such Calendar Quarter;
(f)    Within [***] days following the end of each Calendar Quarter, the Lead
Party shall provide the Participating Party a Development Payment Report (in
electronic form) in respect of such Calendar Quarter, combining the information
reported by each Party pursuant to Section 7.1.3(b) and showing its calculations
in accordance with Schedule 7.1.1 of the amount of any payments to be made by
the Parties hereunder for such Calendar Quarter as contemplated by Section 7.1.1
(including, as applicable, showing the sharing of Development Costs) and, if
applicable, providing for the netting of such payments; and
(g)    Within [***] days following the end of each Calendar Quarter commencing
with the earlier of (i) the Calendar Quarter in which the First Commercial Sale
of any Collaboration Product occurs in any country in the world and (ii) the
Calendar Quarter in which any of the payments described in Section 7.1.3(d) or
Section 7.1.3(e) are due, the Lead Party shall provide to the Participating
Party a written Profit Payment Report (in electronic form) in respect of such
Calendar Quarter, combining the information reported by each Party pursuant to
Section 7.1.3(c), Section 7.1.3(d), and Section 7.1.3(e) and showing its
calculations in accordance with Schedule 7.1.1 of the amount of any payments to
be made by the Parties hereunder for such Calendar Quarter as contemplated by
Section 7.1.1 (including, as applicable, showing the calculation of the Profit
Split or sharing of costs) and, if applicable, providing for the netting of such
payments.
7.1.4    Recoupment of Excess Development and Commercialization Costs. Subject
to Section 7.1.5:

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(a)    If, with respect to a Calendar Quarter, after the First Commercial Sale
of any Collaboration Product in the Territory, the Profits in such Calendar
Quarter are a positive number and the Lead Party is the Party owing a Quarterly
Profit True-Up payment:
(i)    if the Lead Party has any remaining Recoupment Balance, it shall be
permitted to reduce such Quarterly Profit True-Up payment by an amount equal to
its current Recoupment Balance; provided that if the Lead Party’s current
Recoupment Balance is greater than the amount of such Quarterly Profit True-Up
payment, then such Quarterly Profit True-Up payment shall not be reduced below
zero; and
(ii)    if the Participating Party has any remaining Recoupment Balance, the
Lead Party shall increase such Quarterly Profit True-Up payment by an amount
equal to the Participating Party’s current Recoupment Balance.
(b)    If at any time, the current Recoupment Balance for each Party is the same
amount, then at such time the Recoupment Balance for each Party shall be deemed
to be zero and neither Party shall have any further recoupment rights under this
Section 7.1.4 or Section 7.2.6, if applicable, with respect to any Excess
Development Costs or Excess Commercialization Costs incurred by either Party
prior to such time, but for clarity, the provisions of this Section 7.1.4 or
Section 7.2.6, if applicable, shall continue to apply with respect to any Excess
Development Costs or Excess Commercialization Costs incurred by a Party after
such time.
7.1.5    Quarterly Limit on Recoupment.
(a)    In no event shall the deductions permitted pursuant to Section 7.1.4
reduce the amount of the Quarterly Profit True-Up payment payable pursuant to
Section 7.1.2 with respect to a Calendar Quarter to less [***] of the amount
that would otherwise be payable pursuant to Section 7.1.2 in the absence of
Section 7.1.4 and any unused deductions as a result of this Section 7.1.5(a) or
Section 7.1.4 shall be carried forward to future Calendar Quarters.
(b)    In no event shall the increases required pursuant to Section 7.1.4
increase the amount of the Quarterly Profit True-Up payment payable pursuant to
Section 7.1.2 with respect to a Calendar Quarter to more than [***] of the
amount that would otherwise be payable under Section 7.1.2 in the absence of
Section 7.1.4 and any unused increases as a result of this Section 7.1.5(b) or
Section 7.1.4 shall be carried forward to future Calendar Quarters.
7.1.6    No Double Counting. Notwithstanding anything to the contrary contained
herein, no cost or expense shall be included in Development Costs (or any
component thereof), Shared Commercialization Costs (or any component thereof) or
Other Shared Expenses (or any component thereof), or in the calculation of Net
Sales (or any component thereof), if inclusion

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therein would result in a duplication or double-counting of the same cost or
expense, hereunder or under the Master Agreement or any other Co-Co
Collaboration Agreement or License Agreement.
7.2    Opt-Out Payments. Once a Party exercises its Opt-Out Right:
7.2.1    Royalties. From and after the First Commercial Sale of a Collaboration
Product in a country, for each Calendar Quarter during the applicable Royalty
Term for such Collaboration Product in such country, the Lead Party shall make
royalty payments to the Participating Party on aggregate worldwide annual Net
Sales of such Collaboration Product, on a Collaboration Product-by-Collaboration
Product basis, at the following royalty rates (the “Royalties”):
(a)    If the Opt-Out Party exercises its Opt-Out Right prior to the Phase 2
Completion Date:
Aggregate Annual Net Sales of a given Collaboration Product in the Territory in
a Calendar Year
Royalty Rate
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory up to and including [***] in a given Calendar Year
[***]
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory over [***] and up to and including [***] in a given Calendar Year
[***]
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory over [***] and up to and including [***] in a given Calendar Year
[***]
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory over [***] in a given Calendar Year
[***]

(b)    If the Opt-Out Party exercises its Opt-Out Right after the Phase 2
Completion Date:
Aggregate Annual Net Sales of a given Collaboration Product in the Territory in
a Calendar Year
Royalty Rate
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory up to and including [***] in a given Calendar Year
[***]
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory over [***] and up to and including [***] in a given Calendar Year
[***]
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory over [***] and up to and including [***] in a given Calendar Year
[***]
On the portion of aggregate annual Net Sales of such Collaboration Product in
the Territory over [***] in a given Calendar Year
[***]

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If the Opt-Out Party exercises its Opt-Out Right after the First Commercial Sale
of a Collaboration Product in the first Major Market Country, the Parties shall
negotiate in good faith whether to change (and if so, the change to) the royalty
rates in this Section 7.2.1(b) based on the Opt-Out Party’s contribution to the
Development and Regulatory Approval of the Collaboration Products, the status of
the Collaboration Products and the commercial prospects for the Collaboration
Products.
7.2.2    Royalty Rate Reductions. Notwithstanding the provisions of
Section 7.2.1, if during the Royalty Term for a Collaboration Product in a
country:
(a)    [***]
(b)    [***]
[***]
7.2.3    Manufacturing Technology Transfer Costs Reduction. [***]
7.2.4    Opt-Out Transition Costs Reduction. [***]
7.2.5    In-License Payment Adjustments.
(a)    Existing Alnylam In-Licenses. [***]
(i)    [***]
(ii)    [***]
(b)    Existing Regeneron In-Licenses. [***]
(i)    [***]
(ii)    [***]
(c)    Product-Related In-Licenses. [***]
(i)    [***]
(ii)    [***]
7.2.6    Adjustments for Recoupment of Certain Development and Commercialization
Costs. [***]
(a)    [***]

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(b)    [***]
(c)    [***]
(d)    Schedule 7.2.6 sets forth example applications of Section 7.2.6(a)
through Section 7.2.6(c).
7.2.7    Limit on Reductions or Increases.
(a)    [***]
(b)    [***]
(c)    [***]
(d)    [***]
7.2.8    Royalty Reports. Within [***] days following the end of each Calendar
Quarter, commencing with the Calendar Quarter in which the First Commercial Sale
of any Collaboration Product occurs in any country, (a) the Lead Party shall
provide to the Participating Party a written report (in electronic form) setting
forth, for such Calendar Quarter, (i) the Net Sales of each Collaboration
Product, (ii) Collaboration Product quantities sold, (iii) gross Collaboration
Product sales and a reasonably detailed accounting of the deductions from gross
sales permitted by the definition of Net Sales and (iv) the amount of any
In-License Payments paid by the Lead Party or any of its Affiliates and (b) the
Participating Party shall provide to the Lead Party a written report (in
electronic form) setting forth, for such Calendar Quarter, the amount of any
In-License Payments paid by the Participating Party or any of its Affiliates.
Within [***] days following the end of each Calendar Quarter, the Lead Party
shall deliver the Royalties payment, if any, due to the Participating Party
under Section 7.2.1 for the applicable Calendar Quarter. Such reports shall be
broken down on a country-by-country basis with respect to the Major Market
Countries and the Lead Party shall report the other countries of the Territory
in a consolidated manner.
7.2.9    Third Party Transaction Proceeds.
(a)    [***]
(b)    [***]
(c)    [***]
7.2.10    Other Costs. [***]
7.3    Adjustments to FTE Rates. [***]

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7.4    Invoices and Documentation. The JFC shall approve the form of any
necessary documentation relating to any Development Costs, Profit Split, Royalty
or other payments hereunder so as to afford the Parties appropriate accounting
treatment in relation to any of the transactions or payments contemplated
hereunder. Unless otherwise agreed by the JSC, the financial data in the reports
will include calculations in local currency and Dollars.
7.5    Payment Method and Currency. All payments under this Agreement shall be
made by bank wire transfer in immediately available funds to an account
designated by the Party to which such payments are due. All sums due under this
Agreement shall be payable in Dollars. In those cases where the amount due in
Dollars is calculated based upon one or more currencies other than Dollars, such
amounts shall be converted to Dollars at the average rate of exchange for the
Calendar Quarter to which such payment relates using the arithmetic mean of the
daily rate of exchange, as reported in Thomson Reuters Eikon (or any successor
thereto) or any other source as agreed to by the Parties.
7.6    Taxes. Either Party may withhold from payments due to the other Party
amounts for payment of any withholding tax that is required by Applicable Law to
be paid to any taxing authority with respect to such payments. In such case, the
payor Party will provide the payee Party all relevant documents and
correspondence, and will also provide to the payee Party any other cooperation
or assistance on a commercially reasonable basis as may be necessary to enable
the payee Party to claim exemption from such withholding taxes and to receive a
refund of such withholding tax or claim a foreign tax credit. The payor Party
will give proper evidence from time to time as to the payment of any such tax.
The Parties will cooperate with each other in seeking deductions under any
double taxation or other similar treaty or agreement from time to time in force.
Apart from any withholding permitted under this Section 7.6 and those deductions
expressly included in the definition of Net Sales, the amounts payable hereunder
will not be reduced on account of any taxes, charges, duties or other levies.
Notwithstanding the foregoing, if, as a result of a Withholding Action by the
paying Party (including any assignee or successor), any withholding or deduction
of or on account of taxes, duties, levies, imposts, assessments, deductions,
fees and other similar charges (“Withholding”) is required by Applicable Law and
the amount of such Withholding exceeds the amount of Withholding that would have
been required if the paying Party had not committed the Withholding Action, then
the paying Party shall pay an additional amount to the receiving Party such
that, after Withholding from the payment and such additional amount, the
receiving Party receives the same amount as it would have received from the
paying Party absent such Withholding Action by the paying Party. For the
avoidance of doubt, if as a result of a Withholding Action by a receiving Party
(including any assignee or successor) the amount of Withholding under the law of
the applicable jurisdiction exceeds the amount of such Withholding that would
been required in the absence of such Withholding Action by the receiving Party,
the paying Party shall be required to pay any additional amount only to the
extent that the paying Party would be required to pay any additional amount to
the receiving Party pursuant to the preceding

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sentence if the receiving Party had not committed such Withholding Action. For
purposes of this Section 7.6, “Withholding Action” by a Party means (i) a
permitted assignment or sublicense of this Agreement (in whole or in part) by
such Party to an Affiliate or a Third Party outside of the United States; (ii)
the exercise by such Party of its rights under this Agreement (in whole or in
part) through an Affiliate or Third Party outside of the United States (or the
direct exercise of such rights by an Affiliate of such Party outside of the
United States); (iii) a redomiciliation of such Party, an assignee or a
successor to a jurisdiction outside the United States; and (iv) any action by
such Party that causes this Agreement or any payment to become subject to tax in
a jurisdiction outside of the United States or subject any payments to
Withholding in any jurisdiction that would not have been required absent such
Withholding Action.
7.7    Resolution of Payment Disputes. In the event there is a dispute relating
to any payment obligations or reports hereunder, the Party with the dispute
shall have its representative on the JFC provide the other Party’s
representative on the JFC with written notice setting forth in reasonable detail
the nature and factual basis for such good faith dispute and the Parties,
through the JFC, will seek to resolve the dispute as promptly as possible, but
no later than ten (10) days after such written notice is received. If the JFC is
unable to resolve such payment dispute within such period then the matter shall
be referred to the JSC. The Parties agree that if there is a dispute regarding
any payment amount, only the disputed amount shall be withheld from the payment,
and the undisputed amount shall be paid within the applicable timeframes.
7.8    Late Fee. A late fee [***] as reported on Thomson Reuters Eikon (or any
successor thereto) (or another source agreed to by the Parties) on the date that
the applicable payment was due may be charged by the Party to whom payment is
due with respect to any payment amount from the date such payment amount was
originally due under the terms of this Agreement until such payment amount is
actually paid by one Party to another Party unless such payment amount is
disputed pursuant to Section 7.7, in which case the foregoing late fee shall
commence on the date such dispute is resolved.
7.9    Books and Records. Each Party shall (a) keep proper books of record and
account in which full, true and correct entries (in conformity with Accounting
Standards) shall be made for the purpose of determining the amounts payable or
owed pursuant to this Agreement; (b) keep such books of record and account for
at least [***] Calendar Years following the Calendar Year to which they pertain
(or such longer period to the extent required by Applicable Law) and (c) keep
such books of record and account to the extent related to this Agreement in a
readily available and organized form to allow an independent auditor to verify
the accuracy of all financial, accounting and numerical information provided in
an efficient manner. To the extent a Party is not in compliance with clause (c)
of this Section 7.9, such Party shall be responsible for any additional fees
charged by the independent auditor to the other Party as a result of additional
time spent by the independent auditor assembling or organizing such information.

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7.10    Audits and Adjustments.
7.10.1    Audit. Each Party shall have the right, upon no less than [***]
advance written notice and at such reasonable places, times and intervals and to
such reasonable extent as such Party shall request, not more than once during
any Calendar Year, to have the books of record and account of the other Party to
the extent relating to this Agreement for the preceding [***] Calendar Years
audited by an independent and nationally recognized accounting firm of its
choosing and reasonably acceptable to the other Party, for the sole purpose of
verifying the accuracy of all financial, accounting and numerical information
and calculations provided, and payments made, under this Agreement; provided,
that absent evidence of fraud, gross negligence or willful misconduct no period
may be subjected to audit more than [***].
7.10.2    Results; Costs; Confidentiality. The results of any such audit shall
be delivered in writing to each Party and shall be final and binding upon the
Parties, unless disputed by a Party by notice to the other Party within [***]
days after delivery. [***] Such accountants shall not reveal to the Party
requesting the audit the details of its review, except for the results of such
review and such information as is required to be disclosed under this Agreement,
and shall be subject to the confidentiality provisions contained in ARTICLE 9.
At the request of the Party being audited prior to the audit, the auditing Party
shall cause its accounting firm to enter into a reasonably acceptable
confidentiality agreement with the audited Party obligating such accounting firm
to retain all such information in confidence pursuant to such confidentiality
agreement.
7.10.3    Reconciliation. If any examination or audit of the records described
above discloses an overbilling or underpayment of amounts due hereunder, then
unless the result of the audit is contested pursuant to Section 7.10.2, the
Party that over-billed or underpaid shall pay the same to the Party entitled
thereto within thirty (30) days after receipt of the written results of such
audit pursuant to Section 7.10.1.
7.10.4    Binding and Conclusive. Upon the expiration of the three (3) year
period following the end of any Calendar Year, the calculation of the amounts
payable with respect to such Calendar Year shall be binding and conclusive upon
the Parties.
7.11    Accounting Standards. Except as otherwise provided herein, all costs and
expenses and other financial determinations with respect to this Agreement shall
be determined in accordance with Accounting Standards, as generally and
consistently applied.
ARTICLE 8    
INTELLECTUAL PROPERTY
8.1    Ownership of Intellectual Property.

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8.1.1    Ownership of Technology. Subject to Section 3.6.1(b) and Section 8.1.2,
as between the Parties: (a) Regeneron shall own and retain all right, title and
interest in and to any and all (i) Regeneron Collaboration IP and (ii) other
Information, inventions, Patent Rights, and other intellectual property rights
that are owned or otherwise Controlled by Regeneron, its Affiliates or its or
their Sublicensees, including the Regeneron Technology, and (b) Alnylam shall
own and retain all right, title and interest in and to any and all (i) Alnylam
Collaboration IP and (ii) other Information, inventions, Patent Rights, and
other intellectual property rights that are owned or otherwise Controlled by
Alnylam, its Affiliates or its or their Sublicensees, including the Alnylam
Technology. Regeneron shall own and retain all right, title and interest in and
to any and all Regeneron Background Technology. Alnylam shall, and hereby does,
assign, transfer and otherwise convey, and shall cause its Affiliates and its
and their Sublicensees to so assign, transfer and otherwise convey, to
Regeneron, without additional compensation, all right, title and interest in and
to any Regeneron Background Technology Improvements as is necessary to fully
effect the ownership thereof as provided for in this Section 8.1.1. Alnylam
shall own and retain all right, title and interest in and to any and all Alnylam
Background Technology. Regeneron shall, and hereby does, assign, transfer and
otherwise convey, and shall cause its Affiliates and its and their Sublicensees
to so assign, transfer and otherwise convey, to Alnylam, without additional
compensation, all right, title and interest in and to any Alnylam Background
Technology Improvements as is necessary to fully effect the ownership thereof as
provided for in this Section 8.1.1.
8.1.2    Ownership of Joint Collaboration IP. Subject to Section 3.6.1(b), as
between the Parties, the Parties shall each own an equal, undivided interest in
and to any and all Joint Collaboration IP. Each Party shall promptly disclose to
the other Party in writing, and shall cause its Affiliates and Sublicensees to
so disclose, the development, making, conception or reduction to practice of any
Joint Collaboration IP. Subject to the licenses and rights of reference granted
under Section 6.1 and Section 6.2 and the Parties’ respective exclusivity
obligations under Section 6.7, (a) each Party shall have the right to Exploit
the Joint Collaboration IP without a duty of seeking consent or accounting to
the other Party and (b) each Party hereby grants to the other Party a
non-exclusive license to such Party’s interest in the Joint Collaboration IP for
all purposes. Each Party shall, and hereby does, assign, transfer and otherwise
convey, and shall cause its Affiliates and its and their Sublicensees to so
assign, transfer and otherwise convey, to the other Party, without additional
compensation, all such right, title and interest in and to any Joint
Collaboration IP as is necessary to fully effect the joint ownership thereof as
provided for in this Section 8.1.2.
8.1.3    United States Law. The determination of whether Information and
inventions are conceived, discovered, developed, or otherwise made by a Party
for the purpose of allocating proprietary rights (including Patent Rights,
copyright or other intellectual property rights) therein, shall, for purposes of
this Agreement, be made in accordance with Applicable Law in the United States
irrespective of where such conception, discovery, development or making occurs.
To the extent that the Applicable Law in any jurisdiction other than the United
States affects the

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ownership of intellectual property, as a matter of law, in a manner that is
inconsistent with the application of Applicable Law in the United States, the
Parties shall assign, transfer and otherwise convey, to the other Party, without
additional compensation, all such right, title and interest in and to any
applicable intellectual property as is necessary to fully effect the ownership
thereof as provided for in this Section 8.1.3.
8.1.4    Assignment Obligation. Each Party shall cause all Persons who perform
Development activities, Non-Approval Trials, Manufacturing activities or
regulatory activities for such Party under this Agreement to be under an
obligation to assign their rights in any Information and inventions resulting
therefrom to such Party, except (a) if Applicable Law requires otherwise,
(b) subject to Section 3.1.9, in the case of governmental, not-for-profit and
public institutions which have standard policies against such an assignment, or
(c) in the case of any Third Party services provider (such as a contract
manufacturer or contract research organization), with respect to any Information
or inventions that constitute improvements to the background intellectual
property of such Third Party, in which case ((a) through (c)), such Party shall
use commercially reasonable efforts to obtain a suitable license, or right to
obtain such a license, with respect to such Information and inventions, it being
understood and agreed that in the case of Third Party contract manufacturers and
other service providers it may be commercially reasonable not to obtain a
license, [***] Third Party contract manufacturers are set forth in ARTICLE 5.
8.1.5    Control of Product-Specific Know-How and Product-Specific Patents.
(a)    Alnylam shall ensure that it sufficiently Controls (a) any and all
Information first owned or otherwise controlled (through license or otherwise)
by Alnylam or any of its Affiliates after the Effective Date that would
otherwise be Alnylam Product-Specific Know-How if Controlled by Alnylam and (b)
any and all Patent Rights first owned or otherwise controlled (through license
or otherwise) by Alnylam or any of its Affiliates after the Effective Date that
would otherwise be Alnylam Product-Specific Patents if Controlled by Alnylam, in
each case (a) and (b), such that Alnylam can grant all rights and licenses to
Regeneron hereunder with respect to such Information and Patent Rights as
Alnylam Product-Specific Know-How or Alnylam Product-Specific Patents,
respectively. Notwithstanding the foregoing, this Section 8.1.5(a) shall not
apply to any Information or Patent Rights owned or controlled by an Acquiror or
its Affiliates prior to the closing of a Change of Control of Alnylam, or to any
commitments made by an Acquiror or its Affiliates prior to such closing with
respect to later-developed or later-acquired Information or Patent Rights.
(b)    Regeneron shall ensure that it sufficiently Controls (a) any and all
Information first owned or otherwise controlled (through license or otherwise)
by Regeneron or any of its Affiliates after the Effective Date that would
otherwise be Regeneron Product-Specific Know-How if Controlled by Regeneron and
(b) any and all Patent Rights first owned or otherwise

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controlled (through license or otherwise) by Regeneron or any of its Affiliates
after the Effective Date that would otherwise be Regeneron Product-Specific
Patents if Controlled by Regeneron, in each case (a) and (b), such that
Regeneron can grant all rights and licenses to Alnylam hereunder with respect to
such Information and Patent Rights as Regeneron Product-Specific Know-How or
Regeneron Product-Specific Patents, respectively. Notwithstanding the foregoing,
this Section 8.1.5(b) shall not apply to any Information or Patent Rights owned
or controlled by an Acquiror or its Affiliates prior to the closing of a Change
of Control of Regeneron, or to any commitments made by such Acquiror or its
Affiliates prior to such closing with respect to later-developed or
later-acquired Information or Patent Rights.
8.2    Prosecution and Maintenance of Patents.
8.2.1    Prosecution and Maintenance of Product-Related Patents.
(a)    Prosecution and Maintenance.
(i)    Subject to Section 8.2.1(b), [***].
(ii)    In the event that [***] is the Lead Party:
[***]
(iii)    In all cases, in the event that [***] is the Lead Patent Party,
(A)    [***] shall prepare, file, prosecute, and maintain the Product-Related
Patents in a manner that is in the best interests of the Collaboration Products
hereunder (including to reasonably maximize the scope of any Patent Rights that
could fall within the Product-Related Patents), and without taking into account
any other products other than Collaboration Products [(provided that, [***]
(B)    [***]
(C)    [***]
(b)    Filing Countries. [***]
(c)    [***]
8.2.2    Prosecution and Maintenance of Alnylam Core Technology Patents that are
not also Joint Collaboration Patents[ or Alnylam Delivery Patents]31. [***]
31 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.

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8.2.3    [***]
8.2.4    Prosecution and Maintenance of Regeneron Core Technology Patents that
are not also Joint Collaboration Patents. [***]
8.2.5    Cooperation. [***]
8.2.6    Patent Term Extension and Supplementary Protection Certificate. [***]
8.2.7    Common Ownership Under Joint Research Agreements. Notwithstanding
anything to the contrary in this ARTICLE 8, neither Party shall have the right
to make an election under 35 U.S.C. § 102(c) when exercising its rights under
this ARTICLE 8 without the prior written consent of the other Party. With
respect to any such permitted election, the Parties shall coordinate their
activities with respect to any submissions, filings or other activities in
support thereof. The Parties acknowledge and agree that this Agreement is a
“joint research agreement” as defined in 35 U.S.C. § 100(h).
8.2.8    Patent Listings.
[***]
8.3    Enforcement of Patents and Information.
8.3.1    Notices. Each Party shall promptly notify the other Party in writing of
any (a) known or suspected infringement of any Alnylam Technology or Regeneron
Technology or (b) unauthorized use or misappropriation of any Confidential
Information or Information of a Party by a Third Party of which such Party
becomes aware, in each case, to the extent such alleged infringing, unauthorized
or misappropriating activities involve, as to any Collaboration Product, a
Competing Product with respect thereto in the Field (the “Competitive
Infringement”).
8.3.2    Product-Related IP.
[***]
8.3.3    Alnylam Core Technology Patents and Alnylam Core Technology Know-How
that are not also Joint Collaboration IP[ or Alnylam Delivery Patents]32. [***]

32 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.

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8.3.4    Regeneron Core Technology Patents and Regeneron Core Technology
Know-How that are not also Joint Collaboration IP. [***]
8.3.5    Generic Competition. Notwithstanding the foregoing, if either Party (a)
reasonably believes that a Third Party may be filing or preparing or seeking to
file a generic or abridged Drug Approval Application that refers or relies on
Regulatory Documentation submitted by either Party to any Regulatory Authority,
whether or not such filing may infringe the Product-Related Patents[ or Alnylam
Delivery Patents]33; (b) receives any notice of certification regarding any
Product-Related Patent[ or Alnylam Delivery Patent]34 pursuant to the U.S. “Drug
Price Competition and Patent Term Restoration Act” of 1984 (21 United States
Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) claiming that any
such Patent Rights are invalid or unenforceable or claiming that any such Patent
Rights will not be infringed by the Manufacture, use, marketing or sale of a
product for which an application under the ANDA Act is filed; or (c) receives
any equivalent or similar certification or notice in any other jurisdiction, in
each case ((a) through (c)), it shall (i) notify the other Party in writing
identifying the alleged applicant or potential applicant and furnishing the
information upon which determination is based and (ii) provide such other Party
with a copy of any such notice of certification within ten (10) days of the date
of receipt, and the Parties’ rights and obligations with respect to any legal
action as a result of such certification shall be as set forth in Section 8.3.2
and Section 8.3.6.
8.3.6    Cooperation and Settlement. The Parties agree to cooperate fully in any
Infringement Action pursuant to this Section 8.3. If a Party brings such an
Infringement Action, the other Party shall, where necessary, furnish a power of
attorney solely for such purpose or shall join in, or be named as a necessary
party to, such action. Unless otherwise set forth herein, the Party entitled to
bring any Infringement Action in accordance with this Section 8.3 shall have the
right to settle such claim only with the other Party’s prior written consent,
not to be unreasonably withheld, conditioned or delayed; except that if such
other Party has exercised its Opt-Out Right, the Party entitled to bring such
Infringement Action shall have the right to settle such claim without such other
Party’s consent; provided, however, that such Party shall not have the right to
settle such Infringement Action in a manner that involves an admission of
invalidity or unenforceability with respect to Patent Rights Controlled by such
other Party (including Joint Collaboration Patents), without the prior consent
of the other Party, such consent to be granted or withheld in its sole
discretion. The Party commencing the litigation shall provide the other Party
with copies of all pleadings and other documents filed with the court.
33 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
34 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.

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8.3.7    Recovery. Except as otherwise agreed by the Parties in connection with
a cost sharing arrangement, any recovery realized as a result of an Infringement
Action described in Section 8.3.2, Section 8.3.3, Section 8.3.4 and
Section 8.3.5 (whether by way of settlement or otherwise) with respect to a
Competitive Infringement shall be first allocated to reimburse the Parties for
their costs and expenses in making such recovery (which amounts shall be
allocated pro rata if insufficient to cover the totality of such expenses). Any
remainder after such reimbursement is made shall be:
(a)    if neither Party has exercised its Opt-Out Right, shared [***] by the
Parties;
(b)    if a Party has exercised its Opt-Out Right, and the Lead Patent Party
controlled such Infringement Action, retained by such Lead Patent Party;
provided, however, that to the extent that any award or settlement (whether by
judgment or otherwise) is attributable to loss of sales or profit with respect
to a Collaboration Product, then the Opt-Out Party shall receive either (i) if
the Opt-Out Party exercised its Opt-Out Right prior to the Phase 2 Completion
Date, [***] of such attributable amount of such award or settlement or (ii) if
the Opt-Out Party exercised its Opt-Out Right on or after the Phase 2 Completion
Date, [***] of such attributable amount of such award or settlement; or
(c)    if a Party has exercised its Opt-Out Right, and the non-Lead Patent Party
controlled such Infringement Action, [***] to such non-Lead Patent Party and
[***] to the Lead Patent Party.

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8.4    Administrative Proceedings.
8.4.1    Each Party shall promptly notify the other Party in writing upon
receipt by such Party of information concerning the request for, or filing or
declaration of, any reissue, post-grant review, inter partes review, derivation
proceeding, supplemental examination, interference, opposition, reexamination or
other administrative proceeding relating to any of the Product-Related Patents[
or Alnylam Delivery Patents]35. The Parties shall thereafter consult and
reasonably cooperate to determine a course of action with respect to any such
proceeding and shall reasonably consult with one another in an effort to agree
with respect to decisions on whether to initiate or how to respond to such a
proceeding, as applicable, and the course of action in such proceeding,
including settlement negotiations and terms; provided, however, that, except as
otherwise agreed by the Parties, and except as set forth below in Section 8.4.2,
the Party that has the right to prosecute such Product-Related Patent[ or
Alnylam Delivery Patent, as applicable]36, shall control and have final
decision-making authority with respect to any such proceeding relating to such
Product-Related Patent[ or Alnylam Delivery Patent, as applicable]37.
8.4.2    If any proceeding under Section 8.4.1 involves Patent Rights involved
in an Infringement Action under Section 8.3.2, Section 8.3.3, Section 8.3.4 or
Section 8.3.5, or an invalidity or unenforceability action under Section 8.5,
any decisions on whether to initiate or how to respond to such a proceeding, as
applicable, and the course of action in such proceeding, shall be made by the
Party controlling such Infringement Action or such invalidity or
unenforceability action.
8.4.3    All costs and expenses incurred in connection with any proceeding under
this Section 8.4 will be borne in the same manner as costs and expenses incurred
with respect to prosecution and maintenance of such Patent Rights pursuant to
Section 8.2.
8.5    Invalidity or Unenforceability Defenses or Actions.
8.5.1    Notices. Each Party shall promptly notify the other Party in writing of
any alleged or threatened assertion of invalidity or unenforceability (except as
made in an administrative proceeding under Section 8.4) of any of the
Product-Related Patents[ or Alnylam Delivery Patents]38 by a Third Party,
including in a declaratory judgment action or similar action or claim filed by a
Third Party or as a defense or as a counterclaim in any Infringement Action with
respect to a Competitive Infringement initiated pursuant to Section 8.3.2,
Section 8.3.3, Section 8.3.4 or Section 8.3.5, in each case, of which such Party
becomes aware.
35 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
36 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
37 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
38 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.

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8.5.2    Product-Related Patents[ and Alnylam Delivery Patents]39. [***]
8.5.3    Alnylam Core Technology Patents that are not also Joint Collaboration
Patents[ or Alnylam Delivery Patents]40. Alnylam shall have the sole right, but
not the obligation, to defend and control the defense of the validity and
enforceability of the Alnylam Core Technology Patents that are not also Joint
Collaboration Patents[ or Alnylam Delivery Patents]41 at its own cost and
expense.
8.5.4    Regeneron Core Technology Patents that are not also Joint Collaboration
Patents. Regeneron shall have the sole right, but not the obligation, to defend
and control the defense of the validity and enforceability of the Regeneron Core
Technology Patents that are not also Joint Collaboration Patents at its own cost
and expense.
8.5.5    Cooperation. With respect to Product-Related Patents[ and Alnylam
Delivery Patents]42, each Party shall assist and cooperate with the other Party
as such other Party may reasonably request from time to time in connection with
its activities set forth in this Section 8.5, including by being joined as a
party plaintiff in such action or proceeding, providing access to relevant
documents and other evidence, and making its employees available at reasonable
business hours. In connection with any such defense or claim or counterclaim,
the controlling Party shall keep the other Party reasonably informed of any
steps taken, and shall provide copies of all documents filed, in connection with
such defense, claim, or counterclaim; provided, however, that if a Party has
exercised its Opt-Out Right, the foregoing consultation obligation will be
limited to only those Product-Related Patents[ and Alnylam Delivery Patents]43
Controlled by such Party. In connection with the activities set forth in this
Section 8.5, the controlling Party shall consider in good faith any comments
from the other Party, and each Party shall consult with the other as to the
strategy for the defense of the Product-Related Patents[ and Alnylam Delivery
Patents]44; provided, however, that if a Party has exercised its Opt-Out Right,
the foregoing consultation obligation will be limited to only those Patent
Rights Controlled by such Party.
39 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
40 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
41 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
42 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
43 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.
44 Note to Draft: Include this bracketed language only if the Target is a CNS
Target.

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8.5.6    Costs and Expenses. Unless a Party has exercised its Opt-Out Right, the
Parties shall share [***] the Out-of-Pocket Costs (other than the costs and
expenses of the non-controlling Party’s participation in any claim, suit or
proceeding in the Territory with independent counsel of such Party’s choice as
provided in Section 8.5.2) incurred in defending a claim, suit or proceeding
under Section 8.5.2 with respect to Product-Related Patents as Other Shared
Expenses. If a Party has exercised its Opt-Out Right, then (a) the defending
Party shall bear all costs and expenses (other than the costs and expenses of
the non-controlling Party’s participation in any claim, suit or proceeding in
the Territory with independent counsel of such Party’s choice as provided in
Section 8.5.2) incurred in defending a claim, suit or proceeding under
Section 8.5.2 with respect to Product-Related Patents after the Opt-Out Date,
and (b) if the defending Party is the Lead Party, the Lead Party may offset up
to [***] of such costs and expenses in a given Calendar Quarter incurred in
defending a claim, suit or proceeding under Section 8.5.2 with respect to
Product-Related Patents after the Opt-Out Date against any amounts otherwise
owed to the Participating Party under this Agreement for such Calendar Quarter
subject to Section 7.2.7(c).
8.6    Infringement Claims by Third Parties.
8.6.1    Notices. If the Development, Manufacture or Commercialization of a
Collaboration Product in the Field pursuant to this Agreement results in, or may
result in, an infringement action by a Third Party alleging infringement of such
Third Party’s intellectual property (a “Third Party Infringement Action”), the
Party first receiving notice thereof shall promptly notify the other Party
thereof in writing.
8.6.2    Defense. [***]
8.6.3    Settlement. [***]
8.6.4    Costs and Expenses; Recovery. [***]
8.7    Product Trademarks and Domain Names.
8.7.1    Ownership and Prosecution of Product Trademarks and Domain Names. The
Lead Party shall own all right, title, and interest to the Product Trademarks
and Domain Names in the Territory, and shall be responsible for the
registration, prosecution, maintenance, enforcement and defense thereof. The
Parties shall share equally (50%/50%) the Out-of-Pocket Costs (other than the
costs and expenses of the Participating Party’s participation in any claim, suit
or proceeding with respect to the Product Trademarks and Domain Names with
independent counsel of such Party’s choice) incurred in the with respect to the
Product Trademarks and Domain Names as Other Shared Expenses, unless a Party has
exercised its Opt-Out Right, in which case the Lead

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Party shall bear all such Out-of-Pocket Costs (other than the costs and expenses
of the Participating Party’s participation in any claim, suit or proceeding with
respect to the Product Trademarks and Domain Names with independent counsel of
such Party’s choice) incurred after the Opt-Out Date. The Participating Party
shall provide all assistance and documents reasonably requested by the Lead
Party in support of its prosecution, registration, maintenance, enforcement and
defense of the Product Trademarks and Domain Names.
8.7.2    Ownership of Corporate Names. As between the Parties, each Party shall
retain all right, title and interest in and to its respective Corporate Names.
8.8    Discussion of Potential Material Intellectual Property Issues. Each
Party’s legal/intellectual property department shall keep the other Party’s
legal/intellectual property department reasonably apprised of any potential
material Patent Right or other intellectual property-related issue with respect
to activities under this Agreement, which may be made pursuant to a mutually
acceptable and customary common interest agreement entered into by the Parties;
provided that the foregoing shall not impose any duty on either Party to conduct
or obtain freedom-to-operate or validity or similar opinions of counsel or
Patent Right or other intellectual property clearance searches to the extent not
already conducted or obtained by such Party.
8.9    Intellectual Property that Relates to Multiple Programs. [***]
8.10    [Transition of Patent Matters. Upon Regeneron’s request, subject to
Section 8.2.1(c), Alnylam shall use commercially reasonable efforts to promptly
provide Regeneron with the appropriate documents for the transfer of
responsibility and control of preparation, filing, prosecution, and maintenance
of the Product-Related Patents in the Territory and reasonably cooperate with
Regeneron with respect to such transfer, including executing all papers and
instruments, or requiring its employees or contractors to execute such papers
and instruments, so as to (a) enable Regeneron to apply for and to prosecute,
maintain, defend and enforce the Product-Related Patents in the Territory, and
(b) obtain and maintain any Patent Right extensions, supplementary protection
certificates, and the like with respect to the Product-Related Patents, in each
case ((a) and (b)), to the extent provided for in this Agreement. Alnylam shall
promptly inform Regeneron of any matters coming to Alnylam’s attention that may
materially affect the preparation, filing, prosecution, or maintenance of any
such Product-Related Patents.]45 

45 Note to Draft: Include this bracketed provision only if Regeneron is the
initial Lead Party.

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ARTICLE 9    
CONFIDENTIALITY AND NON-DISCLOSURE
9.1    Confidentiality Obligations. At all times during the Term and for a
period of [***] years following termination or expiration hereof in its
entirety, each Party shall, and shall cause its officers, directors, employees
and agents to, keep confidential and not publish or otherwise disclose to a
Third Party and not use, directly or indirectly, for any purpose, any
Confidential Information furnished or otherwise made known to it, directly or
indirectly, by the other Party, except to the extent such disclosure or use is
expressly permitted by the terms of this Agreement or is necessary or reasonably
useful for the performance of, or the exercise of such Party’s rights under,
this Agreement. “Confidential Information” means any technical, business, or
other information provided by or on behalf of one Party to the other Party in
connection with this Agreement, whether prior to, on, or after the Effective
Date, including information of Third Parties, information relating to the terms
of this Agreement, any Collaboration Product (including the Regulatory
Documentation and Development Data), any Development or Commercialization of any
Collaboration Product, any know-how with respect thereto developed by or on
behalf of the disclosing Party or its Affiliates (including Regeneron Know-How
(which shall be the Confidential Information of Regeneron) and Alnylam Know-How
(which shall be the Confidential Information of Alnylam), as applicable), or the
scientific, regulatory or business affairs or other activities of either Party.
Notwithstanding the foregoing, during the Term, (a) all Regulatory Documentation
owned by the Lead Party pursuant to Section 3.6.1(b) (“Product Regulatory
Documentation”) shall be deemed to be the Confidential Information of the Lead
Party, and the Lead Party shall be deemed to be the disclosing Party and the
Participating Party shall be deemed to be the receiving Party with respect
thereto, (b) all Information Controlled by a Party that is specifically and
solely related to Product-Specific Factors (“Product-Specific Information”)
shall be deemed to be the Confidential Information of both Parties, and both
Parties shall be deemed to be the receiving Party and the disclosing Party with
respect thereto, [***]. For purposes of this Agreement, all confidential
information related to the Target Program or any Collaboration Products
disclosed by a Party under the terms of the Master Agreement is hereby deemed to
be the Confidential Information of such Party and will be treated as if
disclosed hereunder and subject to the terms of this Agreement; provided that
Product Regulatory Documentation, Product-Specific Information and Joint
Collaboration IP shall be subject to the immediately preceding sentence, even if
disclosed under the terms of the Master Agreement. Notwithstanding the
foregoing, the confidentiality and non-use obligations under this Section 9.1
with respect to any Confidential Information shall not include any information
that:
9.1.1    is or hereafter becomes part of the public domain by public use,
publication, general knowledge or the like through no wrongful act, fault or
negligence on the part of the receiving Party or any of its Affiliates or any
Person to whom the receiving Party provided such information;

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9.1.2    can be demonstrated by documentation or other competent proof to have
been in the receiving Party’s possession prior to disclosure by the disclosing
Party without any obligation of confidentiality to the disclosing Party with
respect to such information; provided that the foregoing exception shall not
apply with respect to Product Regulatory Documentation, Product-Specific
Information or Joint Collaboration IP;
9.1.3    is subsequently received by the receiving Party from a Third Party who
is not bound by any obligation of confidentiality to the disclosing Party with
respect to such information; or
9.1.4    can be demonstrated by documentation or other competent evidence to
have been independently developed by or for the receiving Party without
reference to the disclosing Party’s Confidential Information; provided that the
foregoing exception shall not apply with respect to Product Regulatory
Documentation, Product-Specific Information or Joint Collaboration IP.
Specific aspects or details of Confidential Information shall not be deemed to
be within the public domain or in the possession of the receiving Party merely
because the Confidential Information is embraced by more general information in
the public domain or in the possession of the receiving Party. Further, any
combination of Confidential Information shall not be considered in the public
domain or in the possession of the receiving Party merely because individual
elements of such Confidential Information are in the public domain or in the
possession of the receiving Party unless the combination and its principles are
in the public domain or in the possession of the receiving Party.
9.2    Permitted Disclosures. Each Party may disclose Confidential Information
to the extent that such disclosure is:
9.2.1    made in response to a valid order of a court of competent jurisdiction
or other supra-national, federal, national, regional, state, provincial or local
governmental or regulatory body of competent jurisdiction or, if in the
reasonable opinion of the receiving Party’s legal counsel, such disclosure is
otherwise required by Applicable Law, including by reason of filing with
securities regulators; provided, however, that the receiving Party shall first
have given notice to the disclosing Party and given the disclosing Party a
reasonable opportunity to quash such order or to obtain a protective order or
confidential treatment requiring that the Confidential Information and documents
that are the subject of such order or required to be disclosed be held in
confidence by such court or agency or, if disclosed, be used only for the
purposes for which the order was issued or such disclosure was required by
Applicable Law; and provided further that the Confidential Information disclosed
in response to such court or governmental order or as required by Applicable Law
shall be limited to that information which is legally required to be disclosed
in response to such court or governmental order or by such Applicable Law;

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9.2.2    made by or on behalf of the receiving Party to the Regulatory
Authorities as required in connection with any filing, application or request
for INDs or Regulatory Approval pursuant to the terms of this Agreement;
provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information to the extent practicable and
consistent with Applicable Law;
9.2.3    made by the receiving Party or its Affiliates or Sublicensees to its or
their attorneys, auditors, advisors, consultants, contractors, existing or
prospective collaboration partners, licensees, sublicensees, or acquirers as may
be necessary or reasonably useful in connection with, or to its or their
existing or prospective investors, lenders or financing partners as may be
necessary in connection with, the Exploitation of any Collaboration Product, or
otherwise in connection with the performance of its obligations or exercise of
its rights as contemplated by this Agreement, or to potential or actual
investors, lenders, financing partners, collaboration partners, licensees,
sublicensees, or acquirers as may be necessary or reasonably useful in
connection with their evaluation of such potential or actual transaction;
provided, however, that such persons shall be subject to obligations of
confidentiality and non-use with respect to such Confidential Information
substantially similar to the obligations of confidentiality and non-use of the
receiving Party pursuant to this ARTICLE 9 (but with respect to disclosing the
terms of this Agreement to existing or prospective non-strategic financial
investors, lenders or financing partners, then with a duration of
confidentiality as appropriate that is no less than [***] from the date of
disclosure);
9.2.4    with respect to Joint Collaboration IP made by either Party or its
Affiliates as may be necessary or reasonably useful in connection with the
Exploitation of any product so long as such Party or its Affiliates is not in
violation of this Agreement, including under Section 6.1, Section 6.2 and
Section 6.7; or
9.2.5    required under an In-License; provided that the recipient is subject in
writing to substantially the same confidentiality obligations as the Parties.
9.3    Use of Name. Except as expressly provided herein, neither Party shall
mention or otherwise use the name, logo, or Trademark of the other Party or any
of its Affiliates (or any abbreviation or adaptation thereof) in any
publication, press release, marketing and promotional material, or other form of
publicity without the prior written approval of such other Party in each
instance. The restrictions imposed by this Section 9.3 shall not prohibit either
Party from making any disclosure identifying the other Party that is required by
Applicable Law.
9.4    Public Announcements. Neither Party shall issue any other public
announcement, press release, or other public disclosure regarding this Agreement
or its subject matter without the other Party’s prior written consent, except
for any such disclosure that is, in the opinion of the disclosing Party’s
counsel, required by Applicable Law or the rules of a stock exchange on which

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the securities of the disclosing Party are listed (or to which an application
for listing has been submitted) and except that a Party may, once a press
release or other public written statement is approved in writing by both
Parties, make subsequent public disclosure of the information contained in such
press release or other public written statement without the further approval of
the other Party. In the event a Party is, in the opinion of its counsel,
required by Applicable Law or the rules of a stock exchange on which its
securities are listed (or to which an application for listing has been
submitted) to make such a public disclosure, such Party shall submit the
proposed disclosure in writing to the other Party as far in advance as
reasonably practicable (and in no event less than [***] Business Days prior to
the anticipated date of disclosure) so as to provide a reasonable opportunity to
comment thereon. Notwithstanding the foregoing, the Lead Party, its Affiliates
and its and their Sublicensees shall have the right to publicly disclose
research, development and commercial information (including with respect to
regulatory matters) regarding any Collaboration Product; provided (a) such
disclosure is subject to the provisions of this ARTICLE 9 with respect to the
Participating Party’s Confidential Information and (b) the Lead Party shall not
use the name of the Participating Party (or insignia, or any contraction,
abbreviation or adaptation thereof) without the Participating Party’s prior
written permission. Notwithstanding the foregoing, (x) prior to either Party
exercising its Opt-Out Right, to the extent that such disclosure describes the
commencement or “top-line” results of Clinical Trials of a Collaboration
Product, the achievement of any material Development events with respect to a
Collaboration Product or the filing for or receipt of Regulatory Approval with
respect to the Collaboration Product in the Territory (each, a “Major Event”),
at the Participating Party’s request the Lead Party will make such disclosure or
issue such press release jointly with the Participating Party, and (y) after
either Party has exercised its Opt-Out Right, the Lead Party will consider in
good faith any request by the Participating Party to issue a joint press release
or public disclosure with the Participating Party relating to a Major Event.
Prior to making any public disclosure, to the extent practicable, the Lead Party
shall provide the Participating Party with a draft of such proposed disclosure
for the Participating Party’s review and comment, which shall be considered in
good faith by the Lead Party. Unless and until a Party has exercised its Opt-Out
Right, such draft shall be provided to the Participating Party at least [***]
Business Days (or, to the extent faster timely disclosure of a material event is
required by Applicable Law or stock exchange or stock market rules, such shorter
period of time sufficiently in advance of the disclosure so that the
Participating Party will have the opportunity to comment upon the disclosure and
the Lead Party will be able to comply with its obligations as required by
Applicable Law or stock exchange or stock market rules) prior to making any such
disclosure, for the Participating Party’s review and comment, which shall be
considered in good faith by the Lead Party. If a Party has exercised its Opt-Out
Right, such draft shall be provided to the Participating Party at least [***]
(or, to the extent faster timely disclosure of a material event is required by
Applicable Law or stock exchange or stock market rules, such shorter period of
time sufficiently in advance of the disclosure so that the Participating Party
will have the opportunity to comment upon the disclosure and the Lead Party will
be able to comply with its obligations as required by Applicable Law or stock

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exchange or stock market rules) prior to making any such disclosure, for the
Participating Party’s review and comment, which shall be considered in good
faith by the Lead Party. Without limiting the foregoing, 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 shall be entitled to make such filings, except that
the Parties shall cooperate with each other and use reasonable efforts to obtain
confidential treatment of confidential, including trade secret, information in
accordance with Applicable Law. The filing Party shall 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 shall reasonably
consider the non-filing Party’s timely comments thereon and cooperate with such
non-filing Party in seeking such confidential treatment and, upon the written
request of the non-filing Party, shall request an appropriate extension of the
term of the confidential treatment period. For the avoidance of doubt, each
Party shall be responsible for its own legal and other costs in connection with
any filing governed by the terms of this Section 9.4.
9.5    Publications. As between the Parties, the Lead Party shall have the sole
right, in consultation with the Participating Party, to issue and control all
publications in scientific journals and make scientific presentations related to
any Collaboration Product. The Lead Party will consider in good faith any
request by the Participating Party to publish Development results related to any
Collaboration Product; provided that the Participating Party has not exercised
its Opt-Out Right. The Lead Party shall provide the Participating Party with an
advance copy of the proposed publication, and the Participating Party shall then
have [***] days prior to submission for any publication in which to comment and
to recommend any changes it reasonably believes are necessary to preserve any
Patent Rights or Information belonging in whole or in part to the Participating
Party or that is the Confidential Information of the Participating Party. If the
Participating Party informs the Lead Party that such publication, in the
Participating Party’s reasonable judgment, could be expected to have a material
adverse effect on any patentable invention owned by or licensed, in whole or in
part, to the Participating Party, or on any Information that is Confidential
Information of the Participating Party, the Lead Party shall delay or prevent
such publication as follows: (i) with respect to a patentable invention, such
publication shall be delayed sufficiently long (not to exceed [***] days) to
permit the timely preparation and filing of a patent application; and (ii) with
respect to Information that is Confidential Information of such Participating
Party (other than the results of a Clinical Trial or any Product Regulatory
Information), such Information shall be deleted from the publication. The Lead
Party will also consider in good faith any other comments of the Participating
Party. Any publication shall include recognition of the contributions of the
Participating Party according to standard practice for assigning scientific
credit, either through authorship or acknowledgement, as may be appropriate.
9.6    Return of Confidential Information. Upon the effective date of the
expiration pursuant to Section 12.1(a) or termination of this Agreement for any
reason, either Party may request

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in writing, and the other Party shall either, with respect to Confidential
Information to which such other Party does not retain rights under the surviving
provisions of this Agreement: (a) promptly destroy all copies of such
Confidential Information in the possession of the other Party and confirm such
destruction in writing to the requesting Party; or (b) promptly deliver to the
requesting Party, at the other Party’s expense, all copies of such Confidential
Information in the possession of the other Party; provided, however, the other
Party shall be permitted to retain one (1) copy of such Confidential Information
for the sole purpose of performing any continuing obligations hereunder or for
archival purposes. Notwithstanding the foregoing, such other Party also shall be
permitted to retain such additional copies of or any computer records or files
containing such Confidential Information that have been created solely by such
Party’s automatic archiving and back-up procedures, to the extent created and
retained in a manner consistent with such other Party’s standard archiving and
back-up procedures, but not for any other use or purpose. All Confidential
Information shall continue to be subject to the terms of this Agreement for the
period set forth in Section 9.1.
9.7    Confidential Information that Relates to Multiple Programs.
Notwithstanding the foregoing provisions of this ARTICLE 9, if (a) there is
Confidential Information of a Party hereunder that is also Confidential
Information of such Party under the Master Agreement, a License Agreement or
another Co-Co Collaboration Agreement (as “Confidential Information” is defined
in such other agreement), and (b) there is a conflict between the provisions of
this Agreement, on the one hand, and the Master Agreement, a License Agreement
or Co-Co Collaboration Agreement, as applicable, on the other hand, with respect
to the disclosure and non-use of such Confidential Information, the provisions
of the agreement that provides the most protection of a Party’s Confidential
Information (i.e., Regeneron, with respect to Regeneron’s Confidential
Information, and Alnylam, with respect to Alnylam’s Confidential Information)
shall control.
ARTICLE 10    
REPRESENTATIONS AND WARRANTIES
10.1    Mutual Representations and Warranties. Alnylam and Regeneron each
represents and warrants to the other, as of the Effective Date, as follows:
10.1.1    Organization. It is duly organized, validly existing, and in good
standing under the laws of the jurisdiction of its organization, and has all
requisite power and authority, corporate or otherwise, to execute, deliver, and
perform this Agreement.
10.1.2    Authorization. The execution and delivery of this Agreement and the
performance by it of the transactions contemplated hereby have been duly
authorized by all necessary corporate action, and do not violate (a) such
Party’s charter documents, bylaws, or other organizational documents, (b) in any
material respect, any agreement, instrument, or contractual obligation to which
such Party (or any of its Affiliates) is bound, (c) any requirement of any

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Applicable Law, or (d) any order, writ, judgment, injunction, decree,
determination, or award of any court or governmental agency presently in effect
applicable to such Party (or any of its Affiliates).
10.1.3    Binding Agreement. This Agreement is a legal, valid, and binding
obligation of such Party enforceable against it in accordance with its terms and
conditions, subject to the effects of bankruptcy, insolvency, or other laws of
general application affecting the enforcement of creditor rights, judicial
principles affecting the availability of specific performance, and general
principles of equity (whether enforceability is considered a proceeding at law
or equity).
10.1.4    No Debarment. Neither it nor any of its Affiliates, nor its or their
respective employees, have been debarred or are subject to debarment.
10.1.5    No Inconsistent Obligation. It (and each of its Affiliates) is not
under any obligation, contractual or otherwise, to any Person that conflicts
with or is inconsistent in any material respect with the terms of this
Agreement, or that would impede the diligent and complete fulfillment of its
obligations hereunder.
10.1.6    Governmental Consents. Except as set forth in Section 4.9 of the
Master Agreement, no authorization, consent, approval, license, exemption of, or
filing or registration with, any court or governmental department, commission,
board, bureau, agency or instrumentality, domestic or foreign, under any
Applicable Law currently in effect, is or will be necessary to be obtained by
such Party for, or in connection with, the transaction contemplated by this
Agreement, or for the performance by it of its obligations under this Agreement,
except as set forth in Section 3.6.
10.1.7    Third Party Consents. Except as set forth in Section 4.9 of the Master
Agreement, it has obtained all necessary authorizations, consents and approvals
of any Third Party that is required to be obtained by it as of the Effective
Date for, or in connection with, the transaction contemplated by this Agreement,
or for the performance by it of its obligations under this Agreement, except as
set forth in Section 3.6.
10.2    Additional Representations, Warranties and Covenants of Alnylam. Except
as provided in Schedule 10.2, Alnylam further represents and warrants to
Regeneron, as of the Effective Date, and covenants, as follows:
10.2.1    Alnylam is the sole and exclusive owner of, or otherwise Controls
pursuant to an Existing Alnylam In-License (or will Control pursuant to an
Additional Alnylam In-License at such time that such Additional Alnylam
In-License is included as an Existing Alnylam In-License pursuant to Section
6.5.2), the Alnylam Background Technology, and all of the Alnylam Background
Technology licensed to Regeneron hereunder that is solely and exclusively owned
by Alnylam is free and clear of liens, charges or encumbrances other than
licenses and rights granted to Third

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Parties that are not inconsistent with the rights and licenses granted to
Regeneron under this Agreement.
10.2.2    Alnylam has sufficient legal or beneficial title and ownership of, or
sufficient license rights under, the Alnylam Background Technology to grant the
licenses to such Alnylam Background Technology granted to Regeneron pursuant to
this Agreement.
10.2.3    To Alnylam’s Knowledge, (x) Schedule 1.17 sets forth a complete and
accurate list of the Alnylam Core Technology Patents and (y) Schedule 1.28 sets
forth a complete and accurate list of the Alnylam Product-Specific Patents.
Schedule 1.17 indicates whether each Alnylam Core Technology Patent is (a) owned
exclusively by Alnylam or any of its Affiliates, (b) owned jointly by Alnylam or
any of its Affiliates, on the one hand, and one or more Third Parties, on the
other hand, or (c) licensed to Alnylam or any of its Affiliates. For each
Alnylam Core Technology Patent that is owned, but not owned exclusively, by
Alnylam or any of its Affiliates, or that is licensed to Alnylam or any of its
Affiliates, Schedule 1.17 identifies the Third Party owner(s) and, if
applicable, the Existing Alnylam In-License pursuant to which Alnylam Controls
such Alnylam Core Technology Patent. For each Alnylam Core Technology Patent
that is licensed, but not exclusively licensed, to Alnylam, Schedule 1.17
indicates the non-exclusive nature of the license. Alnylam or one of its
Affiliates is the sole and exclusive owner of all Alnylam Core Technology
Patents identified on Schedule 1.17 as being owned exclusively by Alnylam or any
of its Affiliates and Alnylam Controls, pursuant to an Existing Alnylam
In-License, all other Patent Rights identified on such schedules. Alnylam or one
of its Affiliates is the sole and exclusive owner of all Alnylam
Product-Specific Patents identified on Schedule 1.28.
10.2.4    All Alnylam Patents for which Alnylam or any of its Affiliates
controls prosecution and maintenance (the “Alnylam Managed Patents”) are filed
and maintained properly and correctly and, to Alnylam’s Knowledge, all
applicable fees have been paid on or before any final due date for payment.
Alnylam has complied with all Applicable Laws, including any duties of candor to
applicable patent offices, in connection with the filing, prosecution and
maintenance of the Alnylam Managed Patents.
10.2.5    To Alnylam’s Knowledge, the Alnylam Patents are, or, upon issuance,
will be, valid and enforceable Patent Rights.
10.2.6    [***]
10.2.7    [***]
10.2.8    Alnylam has obtained from all inventors of Alnylam Background
Technology that is indicated on Schedule 1.17 or Schedule 1.28 as being solely
and exclusively owned by Alnylam or any of its Affiliates valid and enforceable
agreements that have assigned to Alnylam or

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its Affiliate each such inventor’s entire right, title and interest in and to
all such Alnylam Background Technology.
10.2.9    To Alnylam’s Knowledge, the Exploitation of the Alnylam Background
Technology with respect to the Collaboration Products as contemplated under this
Agreement, (a) does not and will not infringe any issued Patent Right of any
Third Party or misappropriate any Information or other intellectual property of
any Third Party and (b) will not infringe the claims of any published Third
Party patent application when and if such claims were to issue in their current
form.
10.2.10    [***]
10.2.11    Schedule 1.107 sets forth a complete and accurate list of all
agreements between Alnylam and a Third Party entered into prior to the Effective
Date pursuant to which Alnylam Controls (or will Control pursuant to an
Additional Alnylam In-License at such time that such Additional Alnylam
In-License is included as an Existing Alnylam In-License pursuant to Section
6.5.2) Information or Patent Rights that are necessary or reasonably useful to
the practice of the Alnylam Background Technology as contemplated in this
Agreement. Alnylam has provided Regeneron with true and complete copies of all
Existing Alnylam In-Licenses and Additional Alnylam In-Licenses. [***]
10.2.12    To Alnylam’s Knowledge, no Existing Alnylam CMO has made or generated
any improvement, discovery or Information, patentable or otherwise, in the
course of performing services for Alnylam or any of its Affiliates with respect
to any siRNA drug product that is (a) necessary to establish and validate a
manufacturing process for such siRNA drug product at another Existing Alnylam
CMO (or another Third Party contract manufacturer, as the case may be) and
(b) not owned or Controlled by Alnylam. [***]
10.2.13    Part 1 of Schedule 10.2.13 sets forth a true, correct and complete
list of all [***]. Part 2 of Schedule 10.2.13 sets forth a true, correct and
complete description of all terms and conditions [***].
10.3    Additional Representations and Warranties of Regeneron. Except as
provided in Schedule 10.3, Regeneron further represents and warrants to Alnylam,
as of the Effective Date, as follows:
10.3.1    Neither Regeneron nor any of its Affiliates has granted any Third
Party, and neither Regeneron nor any of its Affiliates is under any obligation
to grant any Third Party, any right to Exploit any Collaboration Product in the
Territory, except as set forth in Section 6.7.3.

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10.3.2    To Regeneron’s Knowledge, Schedule 1.258 sets forth a complete and
accurate list of the Regeneron Product-Specific Patents. Regeneron or one of its
Affiliates is the sole and exclusive owner of all Regeneron Product-Specific
Patents identified on Schedule 1.258. Regeneron has sufficient legal or
beneficial title and ownership of, or sufficient license rights under, the
Regeneron Product-Specific Patents and Regeneron Product-Specific Know-How
within the Regeneron Background Technology to grant the licenses to such
Regeneron Product-Specific Patents and Regeneron Product-Specific Know-How
granted to Alnylam pursuant to this Agreement.
10.3.3    All Regeneron Product-Specific Patents for which Regeneron or any of
its Affiliates controls prosecution and maintenance (the “Regeneron Managed
Patents”) are filed and maintained properly and correctly and, to Regeneron’s
Knowledge, all applicable fees have been paid on or before any final due date
for payment. Regeneron has complied with all Applicable Laws, including any
duties of candor to applicable patent offices, in connection with the filing,
prosecution and maintenance of the Regeneron Managed Patents.
10.3.4    To Regeneron’s Knowledge, the Regeneron Product-Specific Patents are,
or, upon issuance, will be, valid and enforceable Patent Rights.
10.3.5    Neither Regeneron nor any of its Affiliates has granted any Third
Party, and neither Regeneron nor any of its Affiliates is under any obligation
to grant any Third Party any rights under Regeneron Product-Specific Know-How or
Regeneron Product-Specific Patents or otherwise assign to any Third Party any
Information or Patent Rights that would otherwise constitute Regeneron
Product-Specific Know-How or Regeneron Product-Specific Patents.
10.3.6    Regeneron has obtained from all inventors of Regeneron
Product-Specific Patents within the Regeneron Background Technology that is
indicated on Schedule 1.258 as being solely and exclusively owned by Regeneron
or any of its Affiliates valid and enforceable agreements that have assigned to
Regeneron or its Affiliate each such inventor’s entire right, title and interest
in and to all such Regeneron Product-Specific Patents within the Regeneron
Background Technology.
10.3.7     There is no (a) claim, demand, suit, proceeding, arbitration,
inquiry, investigation or other legal action of any nature, civil, criminal,
regulatory or otherwise, pending or, to Regeneron’s Knowledge, threatened
against Regeneron or any of its Affiliates or (b) judgment or settlement against
or owed by Regeneron or any of its Affiliates, in each case ((a) and (b)), in
connection with the Regeneron Product-Specific Know-How or Regeneron
Product-Specific Patents within the Regeneron Background Technology, including
any claim alleging that (x) the issued patents in such Regeneron
Product-Specific Patents are invalid or unenforceable, or the patent
applications in such Regeneron Product-Specific Patents will, upon issuance, be
invalid or

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unenforceable or (y) the conception, development, reduction to practice,
disclosing, copying, making, assigning or licensing of such Regeneron
Product-Specific Know-How or the practice thereof as contemplated in this
Agreement infringes or would infringe any Patent Rights of any Person or
misappropriates or would misappropriate any Information or other intellectual
property right of any Person.
10.3.8    Regeneron has provided Alnylam with true and complete copies of all
Existing Regeneron In-Licenses (subject to any applicable confidentiality
restrictions). There are no terms or conditions in any Existing Regeneron
In-License or Existing Regeneron Third Party Agreement that (a) would prevent
Alnylam from exercising its rights under this Agreement with respect to the
prosecution, maintenance, enforcement or defense of any Product-Related IP;
(b) would require Regeneron or any of its Affiliates to grant any Third Party
rights under Regeneron Product-Specific Know-How or Regeneron Product-Specific
Patents or (c) grant to any Third Party contractual exclusivity with respect to
the development, manufacture or commercialization of an siRNA Directed to the
Target. Neither Regeneron nor its Affiliates are in material breach or default
under any Existing Regeneron In-License, nor, to Regeneron’s Knowledge, is any
counterparty thereto in material breach of any Existing Regeneron In-License,
and neither Regeneron nor its Affiliates have received any written notice of
breach or default with respect to any Existing Regeneron In-License. The
licenses granted to Regeneron or its Affiliates in the Existing Regeneron
In-Licenses are in full force and effect and, subject to their terms, are
sublicenseable to Alnylam as contemplated by this Agreement. The execution and
performance of this Agreement does not constitute a material breach of any
Existing Regeneron In-License.
10.3.9    Schedule 10.3.9 sets forth a true, correct and complete list of all
[***] pursuant to this Agreement.
10.4    DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH
HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER
WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY,
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS
TO THE VALIDITY OF ANY PATENT RIGHTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL
PROPERTY RIGHTS OF THIRD PARTIES. FOR THE AVOIDANCE OF DOUBT, THE FOREGOING IS
NOT INTENDED TO LIMIT IN ANY WAY ANY EXPRESS REPRESENTATIONS OR WARRANTIES MADE
BY EITHER PARTY UNDER THE MASTER AGREEMENT, ANY LICENSE AGREEMENT OR ANY OTHER
CO-CO COLLABORATION AGREEMENT.

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10.5    Additional Covenants.
10.5.1    Compliance. Each Party and its Affiliates and Sublicensees shall
conduct the Development, Manufacture and Commercialization of the Collaboration
Products in material accordance with all Applicable Laws and industry standards,
including, to the extent applicable, current governmental regulations concerning
good laboratory practices, good clinical practices and good manufacturing
practices. Neither Party shall export any technology licensed to it by the other
Party under this Agreement except in compliance with U.S. export laws and
regulations.
10.5.2    Debarment. Neither Party nor any of its Affiliates will use in any
capacity, in connection with the performance of its obligations under this
Agreement, any Person that has been debarred. Each Party agrees to inform the
other Party in writing promptly if it learns that it or any Person that is
performing activities in connection with activities under this Agreement is
debarred or is subject to debarment, or, to the notifying Party’s Knowledge, if
debarment of the notifying Party or any Person used in any capacity by such
Party or any of its Affiliates in connection with the performance of its
obligations under this Agreement, is threatened.
ARTICLE 11    
INDEMNITY
11.1    Indemnity.
11.1.1    Alnylam’s Indemnification Obligations. Alnylam shall defend, indemnify
and hold harmless Regeneron, its Affiliates and its and their respective
officers, directors, employees and agents (“Regeneron Indemnitees”) from and
against all loss, liabilities, damages, penalties, fines and expenses, including
reasonable attorneys’ fees and costs payable to a Third Party (collectively,
“Damages”), incurred by any Regeneron Indemnitee as a result of a Third Party’s
claim, action, suit, settlement, or proceeding (each, a “Claim”) against a
Regeneron Indemnitee to the extent such Claim arises out of or results from:
(a)    the gross negligence, recklessness, willful misconduct, or intentional
wrongful acts or omissions of Alnylam or any of its Affiliates (or its or their
respective agents, contractors, Sublicensees, partners, representatives or other
Persons working on its or their behalf) in its or their respective performance
under this Agreement, the Supply Agreement (if any) or the Quality Agreement (if
any), including (i) any activities under any Development Plan and Budget or the
Manufacture and supply of (A) the Early Stage Supply Requirements and (B) if
applicable, Late Stage Supply Requirements, (ii) Alnylam’s performance of
Alnylam Specific Activities, and (iii) if Alnylam is the Lead Party, in
connection with the Exploitation of any Collaboration Product by or on behalf of
Alnylam;

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(b)    a breach by Alnylam of this Agreement (including the inaccuracy of any
representation or warranty made by Alnylam in this Agreement), the Supply
Agreement (if any) or the Quality Agreement (if any);
(c)    if Regeneron exercises its Opt-Out Right, the Exploitation of any
Collaboration Product by or on behalf of Alnylam pursuant to this Agreement from
and after the Opt-Out Date (excluding any activities with respect to such
Exploitation performed by or on behalf of Regeneron);
(d)    any amounts payable to a Third Party under an Alnylam In-License based on
a sharing with such Third Party of (i) amounts paid to Alnylam by Regeneron
pursuant to this Agreement or (ii) any profits or losses received by Alnylam
pursuant to this Agreement or (iii) any Third Party Transaction Proceeds (e.g.,
any amounts payable to a Third Party that constitute a share of any sublicensing
income); or
(e)    the Excluded Agreements or any of the intellectual property licensed
thereunder (including infringement or misappropriation thereof) with respect to
the activities hereunder;
except, in the case of (a), (b) and (c), for those Damages for which Regeneron
has an obligation to indemnify Alnylam pursuant to Section 11.1.2(a) or
Section 11.1.2(b), as to which Damages each Party shall indemnify the other
Party and the Regeneron Indemnitees or Alnylam Indemnitees, as applicable, to
the extent of its respective liability for such Damages.
11.1.2    Regeneron’s Indemnification Obligations. Regeneron shall defend,
indemnify and hold harmless Alnylam, its Affiliates and its and their respective
officers, directors, employees and agents (“Alnylam Indemnitees”) from and
against all Damages incurred by any Alnylam Indemnitee as a result of a Claim
against an Alnylam Indemnitee to the extent such Claim arises out of or results
from:
(a)    the gross negligence, recklessness, willful misconduct, or intentional
wrongful acts or omissions of Regeneron or any of its Affiliates (or its or
their respective agents, contractors, Sublicensees, partners, representatives or
other Persons working on its or their behalf) in its or their respective
performance under this Agreement, including (i) any activities under any
Development Plan and Budget and, if applicable, the Manufacture and supply of
the Late Stage Supply Requirements, and (ii) if Regeneron is the Lead Party, in
connection with the Exploitation of any Collaboration Product by or on behalf of
Regeneron;
(b)    a breach by Regeneron of this Agreement (including the inaccuracy of any
representation or warranty made by Regeneron in this Agreement);

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(c)    if Alnylam exercises its Opt-Out Right, the Exploitation of any
Collaboration Product by or on behalf of Regeneron pursuant to this Agreement
from and after the Opt-Out Date (excluding any activities with respect to such
Exploitation performed by or on behalf of Alnylam); or
(d)    any amounts payable to a Third Party under a Regeneron In-License based
on a sharing with such Third Party of (i) amounts paid to Regeneron by Alnylam
pursuant to this Agreement or (ii) any profits or losses received by Regeneron
pursuant to this Agreement or (iii) any Third Party Transaction Proceeds (e.g.,
any amounts payable to a Third Party that constitute a share of any sublicensing
income);
except, in the case of (a), (b) and (c), for those Damages for which Alnylam has
an obligation to indemnify Regeneron pursuant to Section 11.1.1(a) or
Section 11.1.1(b), as to which Damages each Party shall indemnify the other
Party and the Regeneron Indemnitees or Alnylam Indemnitees, as applicable, to
the extent of its respective liability for such Damages.
11.1.3    Shared Damages. With respect to any Damages arising out of any Claim
brought against any Alnylam Indemnitee or Regeneron Indemnitee resulting from
(a) the Exploitation of any Collaboration Product pursuant to this Agreement
prior to the date on which a Party exercises its Opt-Out Right or (b) the
conduct of a Clinical Trial of Collaboration Product hereunder that is ongoing
as of the date on which a Party exercises its Opt-Out Right and for which the
Opt-Out Party is required to continue to co-fund Development Costs in Section
3.5.7 (as such Clinical Trial is set forth in the Development Plan and Budget as
of the date of the exercise of such Opt-Out Right), in each case, including
personal injury or death resulting from use of any Collaboration Product and any
Claim alleging that the Exploitation of a Collaboration Product pursuant to this
Agreement infringed a Patent Right of a Third Party, but for which (i) Alnylam
is not otherwise obligated to indemnify a Regeneron Indemnitee pursuant to
Section 11.1.1(a), 11.1.1(b), or 11.1.1(d), and (ii) Regeneron is not otherwise
obligated to indemnify an Alnylam Indemnitee pursuant to Section 11.1.2(a),
11.1.2(b) or 11.1.2(d) (such Claim, a “Shared Claim” and such Damages, “Shared
Damages”), each Party shall indemnify the other Party for fifty percent (50%) of
the Shared Damages and during the Term the Shared Damages shall be shared by the
Parties as Other Shared Expenses.
11.2    Indemnity Procedure.
11.2.1    Notification. The Party entitled to indemnification under
Section 11.1.1 or Section 11.1.2 (an “Indemnified Party”) shall notify the Party
potentially responsible for such indemnification (the “Indemnifying Party”)
within five (5) Business Days of becoming aware of any Claim asserted or
threatened in writing against the Indemnified Party that could give rise to a
right of indemnification under this Agreement; provided, however, that the
failure to give such

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notice shall not relieve the Indemnifying Party of its obligations hereunder
except to the extent that such failure materially prejudices the Indemnifying
Party. Each Party shall promptly notify the other Party in writing of any Shared
Claim of which such Party becomes aware.
11.2.2    Control of Defense. If the Indemnifying Party elects in writing to the
Indemnified Party that it will assume control of the defense of such Claim, the
Indemnifying Party shall have the right to defend 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 the Indemnified Party consents to such
compromise or settlement, which consent shall not be unreasonably withheld,
conditioned or delayed, and which consent shall be deemed given with respect to
any Damages relating solely to the payment of money damages if 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. If the Indemnifying Party does not elect to assume
control of the defense of such Claim within [***] days of its receipt of notice
thereof, or if the Indemnifying Party elects in writing to the Indemnified Party
to cease maintaining control of the defense of such Claim, the Indemnified Party
shall have the right upon at least [***] 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 Claim. The Indemnified
Party may not compromise or settle such Claim without the prior written consent
of the Indemnifying Party, such consent not to be unreasonably withheld,
conditioned or delayed.
11.2.3    Indemnified Party’s Participation. The Indemnified Party shall
cooperate with the Indemnifying Party in, and may participate in, but not
control, any defense or settlement of any Claim controlled by the Indemnifying
Party pursuant to this Section 11.2 and shall bear its own costs and expenses
with respect to such participation; provided, however, that, if counsel for the
Indemnifying Party shall have reasonably determined that such counsel may not
properly represent both the Indemnifying Party, on the one hand, and the
Indemnified Party and Alnylam Indemnitees or Regeneron Indemnitees, as
applicable, on the other hand, (a) if a Claim is a Shared Claim, such costs and
expense shall be Other Shared Expenses and (b) if a Claim is not a Shared Claim,
the Indemnifying Party shall bear such costs and expenses.
11.2.4    Defense Procedures For Shared Claims. The indemnification procedures
in this Section 11.2 shall apply to Shared Claims pursuant to Section 11.1.3;
provided that the Lead

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Party shall be deemed to be the Indemnifying Party and the Participating Party
shall be deemed to be the Indemnified Party. For clarity, such allocation of
roles shall only apply to the procedures described in this Section 11.2, and the
cross-indemnity described in Section 11.1.3 shall continue to apply.
11.2.5    Expenses. With respect to Claims under Section 11.1.1 or
Section 11.1.2, the costs and expenses, including fees and disbursements of
counsel, (a) incurred by the Indemnifying Party, shall be the responsibility of
the Indemnifying Party or (b) incurred by the Indemnified Party pursuant to the
proviso in Section 11.2.3 shall be reimbursed on a Calendar Quarter basis by the
Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to indemnification and subject to refund
in the event the Indemnifying Party is ultimately held not to be obligated to
indemnify the Indemnified Party or the Alnylam Indemnitees or Regeneron
Indemnitees, as applicable. With respect to Claims under Section 11.1.3, the
costs and expenses, including fees and disbursements of counsel, incurred by
either Party, shall be Other Shared Expenses.
11.3    Insurance. During the Term and for a minimum period of five (5) years
thereafter and for an otherwise longer period as may be required by Applicable
Law, each of Regeneron and Alnylam shall (a) use Commercially Reasonable Efforts
to procure and maintain appropriate commercial general liability and product
liability insurance in an [***] or (b) procure and maintain adequate insurance
by means of self-insurance in such amounts and on such terms as are consistent
with normal business practices of large pharmaceutical companies in the life
sciences industry. Such insurance shall insure against liability arising from
this Agreement on the part of Regeneron or Alnylam, respectively, or any of
their respective Affiliates, due to injury, disability or death of any person or
persons, or property damage arising from activities performed in connection with
this Agreement. It is understood that such insurance shall not be construed to
create a limit of either Party’s liability with respect to its indemnification
obligations under Section 11.1 or otherwise. Any insurance proceeds received by
a Party in connection with any Damages shall be retained by such Party and shall
not reduce any obligation of the other Party.
ARTICLE 12    
TERM AND TERMINATION
12.1    Term. This Agreement shall be effective as of the Effective Date and,
unless earlier terminated in accordance herewith, shall continue in force and
effect until (a) if neither Party has exercised its Opt-Out Right, the first
date on which neither the Lead Party nor any of its Affiliates or its or their
Sublicensees is Developing any Collaboration Products for, or Commercializing
such Collaboration Products in, the Territory under this Agreement, with the
normal pauses or gaps between or following Clinical Trials or other studies for
the analysis of data, preparation of reports and design of future Clinical
Trials or preparation of Drug Approval Applications and other

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customary Development functions not constituting Clinical Trials not
constituting cessation of Development; or (b) if a Party has exercised its
Opt-Out Right, the date of expiration of the last Royalty Term for the last
Collaboration Product (such period, the “Term”).
12.2    Termination for Material Breach. If either Party (the “Non-Breaching
Party”) believes that the other Party (the “Breaching Party”) has materially
breached this Agreement, the Supply Agreement (if any) or the Quality Agreement
(if any) in a manner that fundamentally frustrates the value or essential
characteristics of the transactions contemplated by this Agreement, then the
Non-Breaching Party may deliver notice of such material breach to the Breaching
Party (a “Default Notice”). If the Breaching Party does not dispute that it has
committed such a material breach under this Agreement, the Supply Agreement (if
any) or the Quality Agreement (if any) that results in the Non-Breaching Party
having a right to terminate this Agreement, then if the Breaching Party fails to
cure such breach, or fails to take steps as would be considered reasonable to
effectively cure such breach, within ninety (90) days after receipt of the
Default Notice, the Non-Breaching Party may terminate this Agreement upon
written notice to the Breaching Party. If the Breaching Party disputes that it
has committed a material breach under this Agreement, the Supply Agreement (if
any) or the Quality Agreement (if any) that results in the Non-Breaching Party
having a right to terminate this Agreement, the dispute shall be resolved
pursuant to Section 13.5. If, as a result of the application of such dispute
resolution procedures, the Breaching Party is determined to have materially
breached in a manner that fundamentally frustrates the value or essential
characteristics of the transactions contemplated by this Agreement (an “Adverse
Ruling”), then if the Breaching Party fails to complete the actions specified by
the Adverse Ruling to cure such material breach within ninety (90) days after
such ruling, the Non-Breaching Party may terminate this Agreement upon written
notice to the Breaching Party; provided that if such compliance cannot be fully
achieved within such ninety (90)-day cure period, then such cure period will be
extended for a period of up to sixty (60) additional days (for a total cure
period of one hundred fifty (150) days) if the Breaching Party prepares and
provides to the Non-Breaching Party a reasonable written plan for curing such
material breach and uses commercially reasonable efforts to cure such material
breach in accordance with such written plan, and if such material breach is not
cured within such one hundred fifty (150)-day period, the Non-Breaching Party
may terminate this Agreement upon written notice to the Breaching Party.
12.3    Termination for Insolvency. In the event that either Party (or its
ultimate parent) (a) files for protection under bankruptcy or insolvency laws,
(b) makes an assignment for the benefit of creditors, (c) appoints or suffers
appointment of a receiver or trustee over substantially all of its property that
is not discharged within ninety (90) days after such filing, (d) proposes a
written agreement of composition or extension of its debts, (e) proposes or is a
party to any dissolution or liquidation, (f) files a petition under any
bankruptcy or insolvency act or has any such petition filed against that is not
discharged within sixty (60) days of the filing thereof, or (g) admits in
writing its inability generally to meet its obligations as they fall due in the
general course, then the other

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Party may terminate this Agreement in its entirety effective immediately upon
written notice to such Party.
12.4    Rights in Bankruptcy. All rights and licenses granted under or pursuant
to this Agreement by Regeneron or Alnylam are, and shall otherwise be deemed to
be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous
provisions in any other country or jurisdiction, licenses of right to
“intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that the Parties, as licensees of such rights under this
Agreement, 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. The Parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against either Party under the
U.S. Bankruptcy Code or any analogous provisions in any other country or
jurisdiction, the Party that is not a party to such proceeding shall be entitled
to a complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual property, which,
if not already in the non-subject Party’s possession, shall be promptly
delivered to it (a) upon any such commencement of a bankruptcy proceeding upon
the non-subject Party’s written request therefor, unless the Party subject to
such proceeding elects to continue to perform all of its obligations under this
Agreement, or (b) if not delivered under clause (a) above, following the
rejection of this Agreement by or on behalf of the Party subject to such
proceeding upon written request therefor by the non-subject Party.
12.5    Additional Lead Party Termination Right. If a Party exercises its
Opt-Out Right, and thereafter, the Lead Party (which may be the New Lead Party,
if applicable), desires to terminate its obligations with respect to Development
and Commercialization of the Collaboration Products, it shall so notify the
Participating Party and thereafter: (a) the Lead Party’s obligation to use
Commercially Reasonable Efforts to Develop and Commercialize Collaboration
Products shall terminate, (b) each Party’s obligations under Section 6.7.1 shall
terminate, (c) the Parties shall cooperate in good faith to license, sell or
otherwise grant or transfer to a Third Party the right to further Develop or
Commercialize the Collaboration Products (but excluding any Proprietary
Unlicensed Components); provided that the Lead Party shall control the process
of licensing, selling or otherwise granting or transferring such right to
further Develop or Commercialize the Collaboration Products and shall have final
say with respect to entering into a transaction with a Third Party with respect
thereto, and (d) the Parties shall share the proceeds of any such transaction as
if they were Third Party Transaction Proceeds at the Third Party Transaction
Proceeds Percentage and negotiate in good faith the terms of termination of this
Agreement to accommodate any such transaction.
12.6    Effects of Termination. In the event of a termination of this Agreement
in its entirety by either Party pursuant to Section 12.2 or Section 12.3 (but
excluding, for clarity, termination pursuant to Section 12.5), the provisions of
Schedule 12.6(B) shall apply, unless (a) the terminating

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Party is the Lead Party and the Lead Party notifies the Participating Party in
writing prior to the effective date of termination that the Lead Party desires
for the provisions of Schedule 12.6(A) to apply or (b) the Participating Party
notifies the Lead Party in writing prior to the effective date of termination
that the Participating Party desires for the provisions of Schedule 12.6(A) to
apply, in which case ((a) or (b)), the provisions of Schedule 12.6(A) shall
apply.
12.7    Remedies. Except as otherwise expressly provided herein, expiration or
termination of this Agreement in accordance with the provisions hereof shall not
limit remedies that may otherwise be available in law or equity.
12.8    Accrued Rights; Surviving Obligations. Termination or expiration of this
Agreement for any reason shall be without prejudice to any rights that shall
have accrued (or that may accrue as a result of activities under this Agreement)
to the benefit of a Party prior to such termination or expiration. Such
termination or expiration shall not relieve a Party from obligations that are
expressly indicated or by their nature are intended to survive the termination
or expiration of this Agreement, including this Section 12.8, 3.4.1 (for the
period set forth therein), 3.4.4, 3.6.2 (last sentence only), 4.9.3, 6.1.1 (with
respect to any perpetual license following the Royalty Term set forth in Section
6.1.1), 6.1.2 (with respect to any perpetual license following the Royalty Term
set forth in Section 6.1.2), 6.1.5 (including the last paragraph of Section 6.1
(i.e., unnumbered paragraph beginning with “Notwithstanding”) as applied to
Sections 6.1.1, 6.1.2, and 6.1.5 only), 6.2.1(b), 6.2.2(a) (with respect to any
perpetual license following the Royalty Term set forth in Section 6.2.2(a)),
6.2.2(b) (with respect to any perpetual license following the Royalty Term set
forth in Section 6.2.2(b)) (including the last paragraph of Section 6.2 (i.e.,
unnumbered paragraph beginning with “Notwithstanding”) as it applies to Sections
6.2.1(b), 6.2.2(a) and 6.2.2(b) only), 6.4, 6.6, 7.1 through 7.2 (to the extent
such payments have accrued but not been paid), 7.5, 7.6, 7.8, 7.9 (for the
period set forth therein), 7.10 (for the three (3)-year period following
expiration or termination of this Agreement), 7.11, 8.1.1, 8.1.2, 8.1.3, 8.2.7,
8.7.2, 9.1 (for the period set forth therein), 9.2 (for the period set forth in
Section 9.1), 9.3, 9.6, 10.4, 12.4, 12.6 (including, for clarity, Schedule
12.6(A) and Schedule 12.6(B), as applicable), 12.7; ARTICLES 1 (to the extent
necessary to interpret the remaining surviving provisions, and including, for
clarity, the corresponding schedules, as applicable), 11 and 13; and Schedules 1
and 2 of this Agreement shall survive the termination or expiration of this
Agreement for any reason.46
46 Note to Draft: Survival sections to be updated based on which provisions are
ultimately included in the Agreement.

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ARTICLE 13    
MISCELLANEOUS
13.1    Force Majeure. Neither Party shall be held liable or responsible to the
other Party or be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement (other
than an obligation to make payments) when such failure or delay is caused by or
results from events beyond the reasonable control of the non-performing Party,
including fires, floods, earthquakes, hurricanes, embargoes, shortages,
epidemics, quarantines, war, acts of war (whether war be declared or not),
terrorist acts, insurrections, riots, civil commotion, strikes, lockouts, or
other labor disturbances (whether involving the workforce of the non-performing
Party or of any other Person), acts of God or acts, omissions or delays in
acting by any governmental authority (except to the extent such delay results
from the breach by the non-performing Party or any of its Affiliates of any term
or condition of this Agreement). The non-performing Party shall notify the other
Party of such force majeure within seven (7) Business Days after such occurrence
by giving written notice to the other Party stating the nature of the event, its
anticipated duration, and any action being taken to avoid or minimize its
effect. The suspension of performance shall be of no greater scope and no longer
duration than is necessary and the non-performing Party shall use commercially
reasonable efforts to remedy its inability to perform.
13.2    Assignment. Without the prior written consent of the other Party, such
consent not to be unreasonably withheld, conditioned or delayed, neither Party
shall sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether
voluntarily, involuntarily, by operation of law or otherwise, this Agreement or
any of its rights or duties hereunder; provided, however, that either Party may
make such an assignment without the other Party’s consent to its Affiliate or to
a successor, whether in a merger, sale of stock, sale of assets or any other
transaction, of all or substantially all of such Party’s business, so long as
such Affiliate or Third Party agrees in writing to be bound by the terms of this
Agreement. With respect to an assignment to an Affiliate, the assigning Party
shall remain responsible for the performance by such Affiliate of the rights and
obligations hereunder. Any attempted assignment or delegation in violation of
this Section 13.2 shall be void and of no effect. All validly assigned and
delegated rights and obligations of the Parties hereunder shall be binding upon
and inure to the benefit of and be enforceable by and against the successors and
permitted assigns of Alnylam or Regeneron, as the case may be. In the event
either Party seeks and obtains the other Party’s consent to assign or delegate
its rights or obligations to another Party, the assignee or transferee shall
assume all obligations of its assignor or transferor under this Agreement.

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13.3    Severability. If any provision of this Agreement is held to be illegal,
invalid, or unenforceable under any present or future law, and if the rights or
obligations of either Party under this Agreement will not be materially and
adversely affected thereby, (a) such provision shall be fully severable, (b)
this Agreement shall be construed and enforced as if such illegal, invalid, or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid, or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid, or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid, and enforceable provision as similar in terms to such illegal,
invalid, or unenforceable provision as may be possible and reasonably acceptable
to the Parties. To the fullest extent permitted by Applicable Law, each Party
hereby waives any provision of law that would render any provision hereof
illegal, invalid, or unenforceable in any respect.
13.4    Governing Law, Jurisdiction and Service.
13.4.1    Governing Law. This Agreement shall be governed by and construed and
enforced 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. Except for (a) JSC Disputes, which are governed by
Section 2.6.3, (b) Financial Disputes, which are governed by Section 13.5,
(c) Expedited Matters, which are governed by Schedule 1, or (d) Expert Disputes,
which are governed by Schedule 2, each Party acknowledges and agrees that it
must commence any action, suit or proceeding arising out of or in connection
with this Agreement (other than appeals therefrom) in the jurisdiction where the
other Party is incorporated or has its principal place of business, and each
Party hereby waives any objections to such jurisdiction and venue and agrees not
to commence any action, suit or proceeding relating to this Agreement except in
courts in such jurisdiction. The Parties shall be free to pursue any rights and
remedies available to them at law, in equity or otherwise, with respect to any
Legal Dispute, subject, however, to this Section 13.4.1 and Section 13.9.
13.4.2    Service. Each Party further agrees that service of any process,
summons, notice or document by registered mail to its address set forth in
Section 13.6.2 shall be effective service of process for any action, suit, or
proceeding brought against it under this Agreement in any such court.
13.5    Dispute Resolution.
13.5.1    Except as provided in Section 13.9 or the last sentence of this
Section 13.5.1, if a dispute arises between the Parties in connection with or
relating to this Agreement or any document or instrument delivered in connection
herewith, including Financial Disputes, Expedited Matters, Legal Disputes and
Expert Disputes, it shall be resolved pursuant to this Section 13.5.

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Notwithstanding the foregoing, the Parties shall resolve all JSC Disputes solely
pursuant to Section 2.6.3 and this Section 13.5 does not apply to any such JSC
Disputes.
13.5.2    Either Party may require that any dispute, other than JSC Disputes
(which are governed by Section 2.6.3), Expedited Matters (which are governed by
Schedule 1 and are referred to Executive Officers pursuant to the terms thereof)
and Expert Disputes (which are governed by Schedule 2), be submitted to the
Executive Officers for resolution by providing written notice to the other Party
formally requesting that the dispute be resolved by the Executive Officers and
specifying the nature of the dispute with sufficient specificity to permit
adequate consideration by such Executive Officers. If a dispute is referred to
the Executive Officers, then the Executive Officers shall diligently and in good
faith attempt to resolve the referred dispute within thirty (30) days after
receiving written notification of such dispute or such longer period of time as
the Executive Officers may agree in writing. Any final decision mutually agreed
to by the Executive Officers with respect to a dispute and set forth in writing
shall be conclusive and binding on the Parties. If the Executive Officers cannot
resolve such dispute within such thirty (30) days or such other period as agreed
by the Executive Officers, such dispute will be resolved as follows:
(a)    with respect to any Financial Dispute, such Financial Dispute shall be
submitted for resolution to a certified public accounting firm jointly selected
by each Party’s certified public accountants or to such other Person as the
Parties shall mutually agree (the “Financial Expert”). The decision of the
Financial Expert shall be final and the costs of the Financial Expert shall be
borne by the Parties in accordance with such allocation as the Financial Expert
shall determine;
(b)    with respect to any Expedited Matter, such Expedited Matter shall be
resolved pursuant to the provisions of Schedule 1;
(c)    with respect to any Expert Dispute, such Expert Dispute shall be resolved
pursuant to the provisions of Schedule 2; and
(d)    with respect to all other disputes (but, for clarity, excluding JSC
Disputes), including Legal Disputes, the Parties shall be free to pursue any
rights and remedies available to them at law, in equity or otherwise subject,
however, to Section 13.4.1 and Section 13.9.
13.6    Notices.
13.6.1    Notice Requirements. All notices, instructions and other
communications required or permitted hereunder or in connection herewith shall
be in writing, shall be sent to the address of the relevant Party set forth at
its address specified in Section 13.6.2 and shall be (a) delivered personally,
or (b) sent via a reputable international overnight courier service. Any such
notice, instruction or communication shall be deemed to have been delivered upon
receipt if

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delivered by hand or one (1) Business Day after it is sent via a reputable
international overnight courier service. Either Party may change its address by
giving notice to the other Party in the manner provided above. This
Section 13.6.1 is not intended to govern the day-to-day business communications
necessary between the Parties in performing their obligations under the terms of
this Agreement.
13.6.2    Address for Notice.
If to Regeneron, to:

Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Attention: President & CEO
Copy: General Counsel

If to Alnylam, to:

Alnylam Pharmaceuticals, Inc.
300 Third Street
Cambridge, Massachusetts 02142
Attention: Legal Department

13.7    Entire Agreement; Amendments.
13.7.1    This Agreement, the Supply Agreement (if any) and the Quality
Agreement (if any), and the Master Agreement, together with the schedules
attached hereto and thereto, sets forth and constitutes the entire agreement and
understanding between the Parties with respect to the subject matter hereof and
all prior agreements, understandings, promises, and representations, whether
written or oral, with respect thereto are superseded hereby. Each Party confirms
that it is not relying on any representations or warranties of the other Party
except as specifically set forth in this Agreement, the Supply Agreement (if
any) and the Quality Agreement (if any), or the Master Agreement. In the event
of a conflict between the provisions of this Agreement and the Master Agreement
with respect to the Target Program (or the Target or Collaboration Products
thereunder), the provisions of this Agreement shall control. For the avoidance
of doubt, the Parties agree and acknowledge that from and after the Effective
Date, there shall be no additional Development, Manufacturing or
Commercialization activities with respect to the Target Program or the
Exploitation of Collaboration Products pursuant to the Master Agreement.
13.7.2    No amendment, modification, release, or discharge shall be binding
upon the Parties unless in writing and duly executed by authorized
representatives of both Parties.

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13.8    LIMITATION OF DAMAGES. IN NO EVENT SHALL REGENERON OR ALNYLAM 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. HOWEVER, NOTHING IN THIS
SECTION 13.8 IS INTENDED TO LIMIT OR RESTRICT (A) LIABILITY FOR BREACH OF
SECTION 6.7.1 OR ARTICLE 9 OR (B) THE INDEMNIFICATION RIGHTS AND OBLIGATIONS OF
EITHER PARTY HEREUNDER AS SET FORTH IN SECTION 11.1 WITH RESPECT TO CLAIMS.
13.9    Equitable Relief.
13.9.1    Each Party acknowledges and agrees that the restrictions set forth in
Section 6.7 and ARTICLE 9 are reasonable and necessary to protect the legitimate
interests of the other Party and that such other Party would not have entered
into this Agreement in the absence of such restrictions, and that any breach or
threatened breach of any provision of such Section or Article may result in
irreparable injury to such other Party for which there will be no adequate
remedy at law. In the event of a breach or threatened breach of any provision of
such Section or Articles, the non-breaching Party shall be authorized and
entitled to seek from any court of competent jurisdiction injunctive relief,
whether preliminary or permanent, specific performance, and an equitable
accounting of all earnings, profits, and other benefits arising from such
breach, which rights shall be cumulative and in addition to any other rights or
remedies to which such non-breaching Party may be entitled in law or equity.
13.9.2    [***]
13.9.3    Each Party hereby waives any requirement that the other Party, as a
condition for obtaining any such relief (a) post a bond or other security or (b)
show irreparable harm, balancing of harms, consideration of the public interest,
or inadequacy of monetary damages as a remedy. Nothing in this Section 13.9 is
intended, or should be construed, to limit either Party’s right to equitable
relief or any other remedy for a breach of any other provision of this
Agreement.
13.10    Waiver and Non-Exclusion of Remedies. Any term or condition of this
Agreement may be waived at any time by the Party that is entitled to the benefit
thereof, but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the Party waiving such term or
condition. The waiver by either Party of any right hereunder or of the failure
to perform or of a breach by the other Party shall not be deemed a waiver of any
other right hereunder or of any other breach or failure by such other Party
whether of a similar nature or otherwise. The rights and remedies provided
herein are cumulative and do not exclude any other right or remedy provided by
Applicable Law or otherwise available except as expressly set forth herein.

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13.11    No Benefit to Third Parties. The covenants and agreements set forth in
this Agreement are for the sole benefit of the Parties and their successors and
permitted assigns, and they shall not be construed as conferring any rights on
any other Persons.
13.12    Further Assurance. Each Party shall duly execute and deliver, or cause
to be duly executed and delivered, such further instruments and do and cause to
be done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as may be necessary or as the other
Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes hereof, or to better assure and
confirm unto such other Party its rights and remedies under this Agreement.
13.13    Relationship of the Parties. It is expressly agreed that Alnylam, on
the one hand, and Regeneron, on the other hand, shall be independent contractors
and that the relationship between the two (2) Parties shall not constitute a
partnership, joint venture, or agency. Neither Alnylam, on the one hand, nor
Regeneron, on the other hand, shall have the authority to make any statements,
representations, or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior written consent of the other Party to
do so. All persons employed by a Party shall be employees of such Party and not
of the other Party and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.
13.14    Counterparts; Facsimile Execution. This Agreement may be executed in
two (2) or more counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument. This Agreement
may be executed by facsimile or electronically transmitted signatures and such
signatures shall be deemed to bind each Party as if they were original
signatures.
13.15    References. Unless otherwise specified, (a) references in this
Agreement to any Article, Section or schedule shall mean references to such
Article, Section or schedule of this Agreement, (b) references in any Section to
any clause are references to such clause of such Section, and (c) 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 amended, replaced, or supplemented from time to time, as so
amended, replaced, or supplemented and in effect at the relevant time of
reference thereto.
13.16    Schedules. In the event of any inconsistencies between this Agreement
and any schedules or other attachments hereto, the terms of this Agreement shall
control.
13.17    Construction. 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 and the word “or” is used in the
inclusive sense (and/or). Whenever this Agreement refers to a number of days,
unless otherwise specified, such number refers to calendar days. The

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captions of this Agreement are for convenience of reference only and in no way
define, describe, extend, or limit the scope or intent of this Agreement or the
intent of any provision contained in this Agreement. The term “including,”
“include,” or “includes” as used herein shall mean including, without limiting
the generality of any description preceding such term. The language of this
Agreement shall be deemed to be the language mutually chosen by the Parties and
no rule of strict construction shall be applied against either Party.

[SIGNATURE PAGE FOLLOWS.]

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THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as
of the Effective Date.

ALNYLAM PHARMACEUTICALS, INC.
REGENERON PHARMACEUTICALS, INC.

By:                   

Name:                   

Title:                   

By:                   

Name:                   

Title:                   

[SIGNATURE PAGE TO CO-CO COLLABORATION AGREEMENT]

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

Schedule 1

Expedited Dispute Resolution

[***]

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

Schedule 2

Expert Resolution

[***]

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

Schedule 1.17
Alnylam Core Technology Patents

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

Schedule 1.28
Alnylam Product-Specific Patents

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

Schedule 1.103
Excluded Agreements

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

Schedule 1.106
Existing Alnylam CMOs

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

Schedule 1.107
Existing Alnylam In-Licenses

1.
Existing Alnylam In-Licenses:

2.
Additional Alnylam In-Licenses:

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

Schedule 1.108
Existing Alnylam Third Party Agreements

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

Schedule 1.109
Existing Regeneron In-Licenses

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

Schedule 1.110
Existing Regeneron Third Party Agreements

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

Schedule 1.165
Manufacturing Cost
[***]

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

[***]

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

[Schedule 1.204]47 
[***]

47 [***].

    

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

Schedule 1.258
Regeneron Product-Specific Patents

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

Schedule 1.287
Target

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

Schedule 3.1.9
Permitted Alnylam Third Party Providers

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

Schedule 3.5.7(a)
[***]

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

Schedule 5.2.2
Key Terms for Supply of Early Stage Supply Requirements
[***]

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

Schedule 5.2.3
Certain Supply Requirements if the Lead Party is Manufacturing
[***]

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

Schedule 7.1.1
Quarterly True-Up Payments
[***]

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

Schedule 7.2.6
Example of Adjustments for Recoupment of Excess Development Costs.

[***]

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

Schedule 8.2.1
Filing Countries
[***]

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

Schedule 10.2
Alnylam Disclosure Schedule48 
[***]

48 [***]

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

Schedule 10.2.13
Certain Obligations under Existing Alnylam In-Licenses

[***]

[***]

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

Schedule 10.3
Regeneron Disclosure Schedule49

[***]

49 Note to Draft: Any exceptions to be added shall be limited to the exceptions
provided in the Program Data Package delivered by Regeneron under the Master
Agreement.

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

Schedule 10.3.9
Certain Payment Obligations under Existing Regeneron In-Licenses

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

Schedule 12.6(A)

Effects of Termination

[***]

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

Schedule 12.6(B)
Effects of Termination
[***]