Exhibit 10.1

EXECUTION COPY

CO-DEVELOPMENT AGREEMENT
By and between
Alnylam Pharmaceuticals, Inc.,
BXLS V Bodyguard – PCP L.P.
AND
BXLS Family Investment Partnership V – ESC L.P.
Dated August 15, 2020

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED
WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT
BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO
THE COMPANY IF DISCLOSED.

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Table of Contents

ARTICLE 1 DEFINITIONS
1
1.1    Defined Terms
1
1.2    Construction
21
1.3    Conflicts
22
ARTICLE 2 THE DEVELOPMENT PROGRAM
22
2.1    The Development Programs
22
2.2    The Protocols
22
2.3    Sponsor
23
2.4    Timeline
23
2.5    CROs and Vendors
23
2.6    Responsibility
23
2.7    Reasonable Assistance
23
ARTICLE 3 DEVELOPMENT PROGRAM RESPONSIBILITIES
24
3.1    Conduct of Clinical Trials
24
3.2    Audits
25
3.3    Product
25
3.4    Pharmacovigilance and Safety Information Exchange
25
3.5    Product Recalls
25
3.6    Disclosures by Alnylam
26
3.7    Licensing Transactions
26
3.8    Change of Control
27
3.9    [***]
27
ARTICLE 4 DEVELOPMENT COSTS
28
4.1    Development Costs
28
4.2    Contingent Nature of Obligation to Fund ALN-AGT Development Costs
29
4.3    Funding Schedule
30
4.4    Use of Proceeds
30
4.5    Development Costs Account
30
ARTICLE 5 GOVERNANCE
31
5.1    Joint Steering Committee
31
5.2    JSC Responsibilities and Decision-Making
32
5.3    Reports
34
ARTICLE 6 PAYMENTS TO BLACKSTONE
34
6.1    Success Payments; Royalty
34
6.2    Payment Adjustments
38
6.3    Method and Timing of Payment
40
6.4    Late Payments
40

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6.5    Taxes.
40
6.6    Accelerated Payment Option
42
ARTICLE 7 SECURITY INTERESTS
43
7.1    Security Interest
43
7.2    Authorization to File Financing Statements
44
7.3    Negative Covenants
44
7.4    Affirmative Covenants
44
7.5    Administrative Agent
49
ARTICLE 8 RECORDS
59
8.1    Accounting
59
8.2    Clinical Trials-Related Records
59
8.3    Records; Audits
60
ARTICLE 9 CONFIDENTIAL INFORMATION
60
9.1    Confidentiality
60
9.2    Authorized Disclosure
61
9.3    Return of Confidential Information
62
9.4    Confidential Status of the Agreement
62
9.5    Publicity
62
ARTICLE 10 INTELLECTUAL PROPERTY
62
10.1    Ownership and Rights
62
10.2    Patent Prosecution
63
10.3    Intellectual Property Enforcement
63
ARTICLE 11 INDEMNIFICATION AND INSURANCE
64
11.1    Indemnification by Each Party
64
11.2    Indemnification Procedure
65
11.3    Insurance
66
ARTICLE 12 REPRESENTATIONS AND WARRANTIES
67
12.1    Representations, Warranties and Covenants of Both Parties
67
12.2    Additional Alnylam Representations, Warranties and Covenants
68
12.3    Blackstone Representation, Warranty and Covenant
71
12.4    DISCLAIMER OF REPRESENTATIONS AND WARRANTIES
71
ARTICLE 13 TERM; CLOSING CONDITIONS; AND TERMINATION
71
13.1    Term
71
13.2    Pre-Signing Conditions
71
13.3    Termination
72
13.4    Additional Consequences of Termination
76
13.5    Surviving Obligations
76
ARTICLE 14 MISCELLANEOUS
77
14.1    Relationship with Affiliates
77
14.2    Prior Agreements
77
14.3    Notices
77

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14.4    Force Majeure
78
14.5    Use of Names
79
14.6    Assignment
79
14.7    Further Assurances
79
14.8    Fees and Expenses
80
14.9    Governing Law
80
14.10    Dispute Resolution
80
14.11    Limitation of Liability
82
14.12    Cumulative Remedies
82
14.13    Relationship of the Parties; Independent Contractors
83
14.14    No Third Party Beneficiaries
83
14.15    Rights Reserved
83
14.16    Amendments; No Waiver
83
14.17    Severability
83
14.18    Entire Agreement
83
14.19    Counterparts
83
14.20    Construction
84

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EXECUTION COPY
CO-DEVELOPMENT AGREEMENT
This Co-Development Agreement (“Agreement”), made effective as of August 15,
2020 (the “Effective Date”), is by and between Alnylam Pharmaceuticals, Inc., a
Delaware corporation (“Alnylam”), BXLS V Bodyguard – PCP L.P., a Delaware
limited partnership organized and existing under the laws of the state of
Delaware (for itself, and as the “Administrative Agent” hereunder), and BXLS
Family Investment Partnership V – ESC L.P., a Delaware limited partnership
organized and existing under the laws of the state of Delaware (each of BXLS V
Bodyguard – PCP L.P. and BXLS Family Investment Partnership V – ESC L.P., a
“Blackstone Entity” and collectively, “Blackstone”) (each, a “Party” and
collectively, the “Parties”).
WHEREAS, Blackstone is in the business of facilitating, among other things, the
development and approval of pharmaceutical products and desires to provide
financing with respect to the design and conduct of certain Clinical Trials for
the development of the Products for certain cardio-metabolic indications; and
WHEREAS, Alnylam has rights to the Products, is designing and conducting (or
preparing to design and conduct) clinical trials of the Products, and would like
to enter into an agreement with Blackstone to provide funding for the continued
development of the Products.
NOW THEREFORE, in consideration of the mutual agreements contained herein and
other good and valuable consideration, the sufficiency of which is hereby
acknowledged, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1    Defined Terms. Initially capitalized terms will have the meaning ascribed
to such terms in this Agreement, including the following terms which will have
the following respective meanings:
1.1.1    “AAA” has the meaning ascribed to such term in Section 3.7.
1.1.2    “Administrative Agent” has the meaning ascribed to such term in the
Preamble.
1.1.3    “Adverse Patent Impact” has the meaning ascribed to such term in
Section 13.3.7.
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1.1.4    “Affiliate” means, with respect to a Party, a business entity under
common control with, or controlling or controlled by, such Party, with “control”
meaning direct or indirect ownership of fifty percent (50%) or more of the
voting interest in such other entity, and in the case of a partnership, control
of the general partner. Notwithstanding the foregoing, neither The Blackstone
Group Inc. nor any of its divisions, including Blackstone Life Science Advisors
L.L.C., will be deemed to be an “Affiliate” of Blackstone. For clarity, with
respect to Alnylam, “Affiliate” shall expressly include Alnylam (Bermuda) Ltd.
1.1.5    “Agent Indemnitee” has the meaning ascribed to such term in Section
7.5.1.5.
1.1.6    “Alliance Manager” has the meaning ascribed to such term in Section
5.1.5.
1.1.7    “ALN-AGT” means, subject to Section 3.9, (a) an RNAi therapeutic
product also known as ALN-AGT targeting angiotensinogen which, as of the
Effective Date, is in Development by Alnylam for the treatment of hypertension
in high unmet need populations, as described on Exhibit A-1 hereto (an “Existing
ALN-AGT Product,” in any form, formulation, dose or dosage form, including any
salt thereof, under any brand name or as a generic product), [***].
1.1.8    “[***]
1.1.9    “ALN-AGT Collateral” means all of Alnylam’s right, title and interest
(excluding any leasehold interest) in, to and under the ALN-AGT Product IP,
whether now owned or existing or hereafter arising or acquired, including, but
not limited to, the Alnylam Intellectual Property set forth in Schedule 7.1.1(a)
hereto, and all proceeds related to any of the foregoing.
1.1.10    “ALN-AGT Development Costs” has the meaning ascribed to such term in
Section 4.1.2.
1.1.11    “ALN-AGT Development Plan” means a written plan for the ALN-AGT
Development Program, the initial version of which is attached hereto as Exhibit
B-1, and which will be subject to amendment by the JSC from time to time during
the Development Term.
1.1.12    “ALN-AGT Development Program” means the development program to be
undertaken by the Parties to Develop ALN-AGT that includes the CMC, clinical and
regulatory strategy for ALN-AGT (including the Clinical Trials to be conducted
by Alnylam for ALN-AGT).
1.1.13    “ALN-AGT Maximum Development Costs” has the meaning ascribed to such
term in Section 4.1.2.
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1.1.14    “ALN-AGT Phase 2 Development Costs” has the meaning ascribed to such
term in Section 4.1.2.
1.1.15    “ALN-AGT Phase 2 Success Payment Trigger” has the meaning ascribed to
such term in Section 6.1.2.1.
1.1.16    “ALN-AGT Phase 2 Success Payments” has the meaning ascribed to such
term in Section 6.1.2.1.
1.1.17    “ALN-AGT Phase 2 Success Target” has the meaning ascribed to such term
in Section 6.2.2.2.
1.1.18    “ALN-AGT Phase 2 Trial” means the Phase 2 Clinical Trial for ALN-AGT
described in the ALN-AGT Development Plan.
1.1.19    “ALN-AGT Phase 3 Approval Target” has the meaning ascribed to such
term in Section 6.2.3.2.
1.1.20    “ALN-AGT Phase 3 Development Costs” has the meaning ascribed to such
term in Section 4.1.2.
1.1.21    “ALN-AGT Phase 3 Success Payment Trigger” has the meaning ascribed to
such term in Section 6.1.3.
1.1.22    “ALN-AGT Phase 3 Success Payments” has the meaning ascribed to such
term in Section 6.1.3.
1.1.23    “ALN-AGT Phase 3 Trial” means the Phase 3 Clinical Trial for ALN-AGT
described in the ALN-AGT Development Plan.
1.1.24    “ALN-AGT Product IP” means any and all (i) Patents, Copyrights,
Trademarks, trade secrets and other intellectual property recognized throughout
the world under Applicable Law, including the Orange Book Patents, (other than
Patents, Copyrights, Trademarks, trade secrets and other intellectual property
recognized under Applicable Law consisting of RPA Assets (as defined in the Term
Loan Agreement as in effect on the date hereof)) that are necessary for, and
material to, the research, Development, manufacture, Commercialization, or other
exploitation of ALN-AGT, in each case, during the term of this Agreement, (ii)
all income, royalties, damages or payments now or hereafter due and/or payable
under any of the foregoing or with respect to any of the foregoing, including,
without limitation, damages or payments for past, present or future
infringements, violations or misappropriations of any of the foregoing, (iii)
the right to sue for past, present and future infringements, violations or
misappropriations of any of the foregoing, (iv) any Regulatory Approval of
ALN-AGT, and (v) all rights corresponding to any of the foregoing throughout the
world; provided, however, that clause (i) shall not include any Shared IP.
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1.1.25    “ALN-AGT Security Interest” has the meaning ascribed to such term in
Section 7.1.2.
1.1.26    “Alnylam” has the meaning ascribed to such term in the Preamble.
1.1.27    “Alnylam Confidential Information” means all Confidential Information
provided or disclosed by or on behalf of Alnylam or its Representatives to
Blackstone or its Representatives hereunder. For clarity, Alnylam Confidential
Information will include any and all CMC Information.
1.1.28    “Alnylam Improvements” has the meaning ascribed to such term in
Section 10.1.1.3.
1.1.29    “Alnylam Indemnified Parties” has the meaning ascribed to such term in
Section 11.1.1.
1.1.30    “Alnylam Intellectual Property” means all Intellectual Property owned
or Controlled by Alnylam or its Affiliates that is necessary or useful for the
Development, manufacture, use, Commercialization, import, or export of the
Products, including Trial Inventions.
1.1.31    “Alnylam Obligations” means all indebtedness, liabilities and other
obligations of Alnylam to Blackstone under or in connection with this Agreement
and other documents executed in connection herewith, including, without
limitation, all amounts payable to Blackstone pursuant to Article 6 hereof and
any and all damages resulting from breach of this Agreement by Alnylam, all
interest accrued thereon, all fees and all other amounts payable by Alnylam to
Blackstone thereunder or in connection therewith, whether now existing or
hereafter arising, and whether due or to become due, absolute or contingent,
liquidated or unliquidated, determined or undetermined, and including interest
that accrues after the commencement by or against Alnylam of any bankruptcy or
insolvency proceeding
1.1.32    “Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act,
as amended, the UK Bribery Act 2010, as amended, and any other applicable
anti-corruption laws and laws for the prevention of fraud, racketeering, money
laundering or terrorism.
1.1.33    “Appellate Rules” has the meaning ascribed to such term in Section
14.10.2.5.
1.1.34    “Applicable Law” means the applicable laws, statutes, rules,
regulations, guidelines, or other requirements of any Governmental Authorities
(including any Regulatory Authorities), to the extent legally binding, that may
be in effect from time to time in any country or regulatory jurisdiction. For
clarity, Applicable Laws will include the FFDCA, the Anti-Corruption Laws, Data
Privacy Laws and all laws, regulations and legally binding guidelines applicable
to the Product Clinical Trials, including GCP, GLP, GMP and ICH guidelines.
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1.1.35    “Approval Indication” means the treatment of the cardiomyopathy of
wild-type or hereditary transthyretin-mediated amyloidosis.
1.1.36    “Blackstone” has the meaning ascribed to such term in the Preamble.
1.1.37    “Blackstone Collateral” means the ALN-AGT Collateral, the Vutrisiran
Collateral and the Development Costs Account, and any proceeds therefrom.
1.1.38    “Blackstone Entity” has the meaning ascribed to such term in the
Preamble.
1.1.39    “Blackstone Indemnified Parties” has the meaning ascribed to such term
in Section 11.1.2.
1.1.40    “Blackstone Security Interests” has the meaning ascribed to such term
in Section 7.1.2.
1.1.41    “Business Day” means a day that is not a Saturday, Sunday or a U.S.
federal holiday. For the avoidance of doubt, with respect to any notice or other
communication required to be given or delivered hereunder, limitations on the
operations of commercial banks due to the outbreak of a contagious disease,
epidemic or pandemic (including COVID-19), or any quarantine, shelter-in-place
or similar or related directive, will not prevent a day that would otherwise be
a Business Day hereunder from so being a Business Day.
1.1.42    “Calendar Quarter” means each successive period of three (3)
consecutive calendar months ending on March 31, June 30, September 30 and
December 31; provided, that, the (a) the first Calendar Quarter will begin on
the Effective Date and end on the last day of the Calendar Quarter in which the
Effective Date falls, and (b) the final Calendar Quarter will end on the last
day of the Term.
1.1.43    “Calendar Year” means each successive period of twelve (12) months
commencing on January 1 and ending on December 31; provided, that, (a) the first
Calendar Year will begin on the Effective Date and end on December 31 of the
Calendar Year in which the Effective Date falls, and (b) the final Calendar Year
will end on the last day of the Term.
1.1.44    “Case Report Form” or “CRF” means the collection of documents designed
specifically for recording data pursuant to a Protocol, which CRF will be
completed for each Clinical Trial subject and will be in electronic form,
validated and in compliance with all Applicable Laws.
1.1.45    “Change of Control” means, with respect to Alnylam, at any time prior
to the date of the payment by Alnylam of the final Success Payment hereunder,
(a) a merger, reorganization or consolidation with a Third Party which results
in the voting securities of
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Alnylam outstanding immediately prior thereto ceasing to represent, or being
converted into or exchanged for voting securities that do not represent, at
least fifty percent (50%) of the combined voting power of the voting securities
of the surviving entity or the parent corporation of the surviving entity
immediately after such merger, reorganization or consolidation, (b) a
transaction in which a Third Party becomes the beneficial owner of fifty percent
(50%) or more of the combined voting power of the outstanding securities of
Alnylam, other than through the issuance of voting securities for the purpose of
raising financing to one or more financial or institutional investors that are
not then controlled by an entity engaged in the development or commercialization
of pharmaceutical or biotechnology products, or (c) the sale or other transfer
of all or substantially all of Alnylam’s business or assets relating to a
Product, provided that a Change of Control will not be deemed to have occurred
in the event that the Third Party in any of the foregoing transactions is a
venture capital fund, pension fund, investment fund, commercial or investment
bank, insurance company, or similar financial institution, in each case that is
not then a controlled Affiliate of a company engaged in the development and/or
commercialization of pharmaceutical or biotechnology products.
1.1.46    “Claim” means any Third Party claim, demand, suit or cause of action.
1.1.47    “Clinical Hold” means, in the U.S., an order issued by FDA to the
sponsor of a Clinical Trial to delay or suspend an ongoing Clinical Trial, as
set forth in 21 U.S.C. §312.42, or outside of the U.S., the foreign equivalent
thereof issued by the applicable Regulatory Authority.
1.1.48    “Clinical Investigator” means the principal investigator at each Site.
1.1.49    “Clinical Trial” means a Phase 1 Clinical Trial, a Phase 2 Clinical
Trial, a Phase 3 Clinical Trial or any supplemental clinical trial (including a
bridging study or a post-approval clinical study) required for the purpose of
obtaining Regulatory Approval.
1.1.50    “Clinical Trial Activity” has the meaning ascribed to such term in
Section 2.4.
1.1.51    “Clinical Trial Agreement” has the meaning ascribed to such term in
Section 3.1.3.
1.1.52    “Clinical Trials Database” has the meaning ascribed to such term in
Section 3.1.4.2.
1.1.53    “CMC” means chemistry, manufacturing and controls.
1.1.54    “CMC Information” means the CMC information intended or required for
the submission of an IND or NDA.
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1.1.55    “CMO” means contract manufacturing organization or contract
development and manufacturing organization.
1.1.56    “Combination Product” means a product that includes Vutrisiran and at
least one additional active pharmaceutical ingredient (whether co-formulated or
co-packaged) that is not Vutrisiran.
1.1.57    “Code” means the U.S. Internal Revenue Code of 1986, as amended.
1.1.58    “Commercialization,” “Commercializing” or “Commercialize” means the
commercial manufacture, marketing, promotion, sale or distribution of a Product.
For clarity, Commercialization excludes all activities associated with
Development and seeking Regulatory Approval for a Product.
1.1.59    “Commercially Reasonable Efforts” means, with respect to the efforts
to be expended by Alnylam in the performance of Alnylam’s obligations hereunder
for the Development and Commercialization of a Product, such level of efforts
(including the devotion of such financial resources) as Alnylam would typically
devote to a product of similar market potential and profitability and at a
similar stage of Development as such Product (as applicable), in each case,
considering relevant market factors, the risk-benefit assessment of the
applicable Product including the data related to clinical outcomes and the
safety profile, products in development or in the marketplace (excluding
consideration of competitive products developed by Alnylam (or its successor or
licensee)), pricing and reimbursement status achieved or likely to be achieved,
and the scope or potential scope of Patent or other intellectual property
protection; provided, however, that, to the extent that the performance of
Alnylam’s obligations hereunder is adversely affected by Blackstone’s failure to
perform its obligations hereunder, the impact on Alnylam of such performance
failure by Blackstone will be taken into account in determining whether Alnylam
has used its Commercially Reasonable Efforts to perform any such affected
obligations.
1.1.60    “Completion Date” means, with respect to a particular Clinical Trial,
the earlier of (a) the date of final database lock for such Clinical Trial and
(b) the date such Clinical Trial or this Agreement is terminated.
1.1.61    “Confidential Information” of a Party means all information and
materials provided or disclosed (including in written form, electronic form or
otherwise) by, or on behalf of, such Party or its Representatives to the other
Party or its Representatives in connection with this Agreement, including,
technical, scientific, regulatory and other information, results, knowledge,
techniques, reports, data, analyses, inventions, invention disclosures, plans,
processes, methods, know-how, ideas, concepts, test data (including
pharmacological, toxicological and clinical test data), analytical and quality
control data, formulae, specifications, marketing, pricing, distribution, cost,
sales, and manufacturing data and descriptions, as well as confidential or
proprietary information of a Third Party that may
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be disclosed hereunder. In addition, the terms and conditions of this Agreement
will be deemed to be Confidential Information of both Blackstone and Alnylam.
1.1.62    “Confidentiality Agreement” means that certain Confidentiality
Agreement, dated November 14, 2019, by and between Alnylam and Blackstone.
1.1.63    “Contingent Liabilities” means, for any Person, any direct or indirect
liability, contingent or not, of that Person for (a) warranty obligations, (b)
potential claims for damages, (c) assessments, and (d) any other condition,
situation or set of circumstances involving various degrees of uncertainty that
may result in a loss or liability.
1.1.64    “Control” or “Controlled” means (a) with respect to Intellectual
Property, a Party’s ability to grant applicable licenses, sublicenses or other
rights thereunder and (b) with respect to materials and documents, a Party’s
ability to provide, or provide access to, such materials or documents, each
without violating any contractual obligations to a Third Party. For clarity, if
a Party only can grant a license or sublicense or provide rights or access of
limited scope, for a specific purpose or under certain conditions due to an
encumbrance, “Control” or “Controlled” will be construed to so limit such
license, sublicense, provision of rights or access.
1.1.65    “Copyrights” means, collectively, all works of authorship, mask works
and any and all other registered and unregistered copyrights and copyrightable
works, and all applications, registrations, extensions, and renewals thereof.
1.1.66    “CRO” means contract research organization.
1.1.67    “CRO Agreement” has the meaning ascribed to such term in Section 2.5.
1.1.68    “CSR” means, with respect to a Product Clinical Trial, a clinical
study report, or other equivalent document or series of materials, constituting
a summary report of the clinical and medical data resulting from such Clinical
Trial and prepared for incorporation into submissions seeking Regulatory
Approval for a Product, and includes all statistical analyses of such data per
the statistical analysis plan.
1.1.69    “Data Privacy Laws” means any applicable state, federal law or foreign
regulation governing the provision, receipt, maintenance, storage, or
destruction of personal data, including but not limited to any applicable
provisions of the European Union General Data Protection Regulation, the United
Kingdom Data Protection Act 2018, the California Consumer Privacy Act, the
Health Insurance Portability and Accountability Act of 1996, the
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Fair Credit Reporting Act, the Fair and Accurate Credit Transactions Act, and
the Gramm Leach-Bliley Act.
1.1.70    “Data Room” means that certain electronic data room established by
Alnylam [***] and to which Blackstone or its advisors were granted access prior
to the Effective Date.
1.1.71    “Deposit Account Control Agreement” has the meaning ascribed to such
term in Section 7.4.1(c).
1.1.72    “Develop,” “Developing,” “Developed” or “Development” means all
clinical research and development activities conducted after filing an IND,
including toxicology, pharmacology test method development and stability
testing, process development, formulation development, quality assurance and
quality control development, statistical analysis, conducting Clinical Trials,
regulatory affairs, and obtaining and maintaining Regulatory Approval.
1.1.73    “Development Costs” means all internal and external costs incurred or
paid by Alnylam in connection with the Development Programs.
1.1.74    “Development Costs Account” means a segregated deposit account with
Bank of America, N.A. or other bank mutually acceptable to the Parties, subject
to a deposit account control agreement between Bank of America, N.A. or such
other bank mutually acceptable to the Parties, Alnylam and Blackstone, and any
successor segregated deposit account established in accordance with Section 7.3.
1.1.75    “Development Events” means the Clinical Trial milestones set forth on
Schedule 4.3 hereto.
1.1.76    “Development Plan” means, as applicable, the Vutrisiran Development
Plan or the ALN-AGT Development Plan.
1.1.77    “Development Program” means, as applicable, the Vutrisiran Development
Program or the ALN-AGT Development Program.
1.1.78    “Development Term” means, with respect to a Product and a Development
Program, the period commencing on the Effective Date and ending on the later of
(a) the latest of the Completion Dates of the Product Clinical Trials in such
Development Program, and (b) the date on which all material efforts in pursuit
of Regulatory Approval of such Product have been concluded or terminated.
1.1.79    “Disclosing Party” has the meaning ascribed to such term in Section
9.1.
1.1.80    “Dispute” has the meaning ascribed to such term in Section 14.10.
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1.1.81    “Effective Date” has the meaning ascribed to such term in the
Preamble.
1.1.82    “Election Date” has the meaning set forth in Section 3.9.2.
1.1.83    “EMA” means the European Medicines Agency and any successor agency
thereto in the EU having substantially the same function.
1.1.84    “EU” means the European Union or any successor union of European
states thereto having a substantially similar function.
1.1.85    “Excluded Licensing Transaction” means [***]
1.1.86    “Executive Officers” means the executive officers of each of Alnylam
and Blackstone identified on Exhibit C.
1.1.87    “Existing ALN-AGT Product” has the meaning ascribed to such term in
Section 1.1.7.
1.1.88    “Existing Licenses” means, (a) with respect to Vutrisiran, [***] and
(b) with respect to ALN-AGT, [***]
1.1.89    “Event of Default” has the meaning ascribed to such term in Section
7.4.2.1.
1.1.90    “Existing Licensors” means, as applicable, [***].
1.1.91    “FDA” means the U.S. Food and Drug Administration and any successor
agency thereto in the U.S. having substantially the same function.
1.1.92    “FFDCA” means the U.S. Food, Drug, and Cosmetic Act, as amended from
time to time, together with any rules, regulations, requirements and guidances
promulgated or issued thereunder (including all additions, supplements,
extensions and modifications thereto).
1.1.93    “Force Majeure Event” has the meaning ascribed to such term in Section
14.4.
1.1.94    “Funding Tranche” means, with respect to the Vutrisiran Development
Costs or the ALN-AGT Development Costs, a portion of such costs to be funded by
Blackstone following Alnylam’s achievement of a Development Event, as set forth
on Schedule 4.3 hereto.
1.1.95    “GAAP” means generally accepted accounting principles in the U.S., as
consistently applied by the applicable Party.
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1.1.96    [***].
1.1.97    [***].
1.1.98    [***].
1.1.99    [***].
1.1.100    “Good Clinical Practices” or “GCP” means all applicable requirements,
standards, practices, and procedures for the design, conduct, performance,
monitoring, auditing, recording, analysis and reporting of Clinical Trials
including (i) FDA’s good clinical practice requirements under the FFDCA and 21
CFR Parts 11, 50, 54, 56, and 312, (ii) all requirements referred to in EudraLex
Volume 10 (Guidelines for Clinical Trials) as well as all corresponding
Applicable Laws implemented by relevant EU member states, (iii) ICH guidance for
Good Clinical Practice, and (iv) the equivalent Applicable Laws in any relevant
country, each as may be amended and applicable from time to time.
1.1.101    “Good Laboratory Practices” or “GLP” means all applicable
requirements, standards, practices, and procedures for conducting non-clinical
laboratory studies, including (i) FDA’s good laboratory practice requirements
under the FFDCA and 21 CFR Part 58, (ii) the United States Animal Welfare Act,
(iii) ICH Guidance on Nonclinical Safety Studies for the Conduct of Human
Clinical Trials for Pharmaceuticals or the ICH Guidance on Safety Pharmacology
Studies for Human Pharmaceuticals, (iv) EU Applicable Laws related to research
and related uses of animals within any EU member state, including Directive
2010/63, and (v) the equivalent Applicable Laws in any relevant country, each as
may be amended and applicable from time to time.
1.1.102    “Good Manufacturing Practices” or “GMP” means all applicable
requirements, standards, practices, and procedures for the manufacture and
testing of pharmaceutical materials including, (a) FDA’s current good
manufacturing practices requirements under the FFDCA and 21 CFR Parts 210 and
211; (b) all requirements referred to in EudraLex Volume 4 (Guidelines for Good
Manufacturing Practice), as well as all corresponding Applicable Laws
implemented by relevant EU member states; (c) ICH Guidance on Good Manufacturing
Practice for Active Pharmaceutical Ingredients; and (d) the equivalent
Applicable Laws in any relevant country, each as may be amended and applicable
from time to time.
1.1.103    “Governmental Authority” means any supranational, federal, national,
state or local court, agency, authority, department, regulatory body or other
governmental instrumentality.
1.1.104    “HELIOS-B Protocol” has the meaning ascribed to such term in Section
2.2.1.1.
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1.1.105    “HELIOS-B Trial” means the registrational trial entitled “A Study to
Evaluate Vutrisiran in Patients with Transthyretin Amyloidosis with
Cardiomyopathy” with identifier NCT04153149.
1.1.106    “ICH” means the International Conference on Harmonization.
1.1.107    “IDMC” means the independent data monitoring committee for a Product
Clinical Trial.
1.1.108    “IND” means an investigational new drug application, Clinical Trial
application, Clinical Trial exemption, or similar application or submission
filed with or submitted to a Regulatory Authority in a jurisdiction that is
necessary to initiate human clinical testing of a pharmaceutical product in such
jurisdiction, including any such application filed with the FDA pursuant to 21
C.F.R. Part 312, as well as all supplements, amendments, variations, extensions
and renewals thereof that may be filed with respect to the foregoing.
1.1.109    “Indemnification Claim Notice” has the meaning ascribed to such term
in Section 11.2.1.
1.1.110    “Indemnified Party” has the meaning ascribed to such term in Section
11.2.1.
1.1.111    “Indemnifying Party” has the meaning ascribed to such term in Section
11.2.1.
1.1.112    “Information” means technical or scientific know-how, trade secrets,
methods, processes, formulae, designs, specifications and data, including
biological, chemical, pharmacological, toxicological, pre-clinical, clinical,
safety, manufacturing and quality control data and assays; in each case, whether
or not confidential, proprietary, patented or patentable.
1.1.113    “Intellectual Property” means all intellectual property and
industrial property rights of any kind or nature throughout the world, including
all U.S. and foreign, (a) Patents; (b) Trademarks; (c) Copyrights; (d)
regulatory filings (e.g., an NDA), (e) rights in computer programs (whether in
source code, object code, or other form), algorithms, databases, compilations
and data, technology supporting the foregoing, and all documentation, including
user manuals and training materials, related to any of the foregoing; (f) trade
secrets and all other Confidential Information, know-how, inventions,
proprietary processes, formulae, models, and methodologies; (g) rights of
publicity, privacy, and rights to personal information; (h) all rights in the
foregoing and in other similar intangible assets; and (i) all applications and
registrations for the foregoing.
1.1.114    “Intercreditor Agreement” means that certain Intercreditor Agreement,
dated as of the date hereof, by and among Blackstone, Wilmington Trust,
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National Association as Collateral Agent, and the other parties from time to
time added thereto, as acknowledged and consented to by Alnylam.
1.1.115    [***].
1.1.116    [***].
1.1.117    “IP Security Agreement” has the meaning ascribed to such term in
Section 7.4.1(a).
1.1.118    “IRB” means institutional review board, or its equivalent.
1.1.119    “JSC” has the meaning ascribed to such term in Section 5.1.1.
1.1.120    “JSC Chairperson” has the meaning ascribed to such term in Section
5.1.2.
1.1.121    “JSC Representative(s)” has the meaning ascribed to such term in
Section 5.1.1.
1.1.122    “Knowledge” means the actual knowledge of [***].
1.1.123    “Licensing Transaction” means: [***].
1.1.124    “Lien” means a mortgage, deed of trust, levy, charge, pledge,
hypothecation, assignment, deposit arrangement, lien (statutory or otherwise),
or preference, priority or other security interest, preferential arrangement in
the nature of a security interest or other encumbrance of any kind or nature
whatsoever, whether voluntarily incurred or arising by operation of law or
otherwise against any property (including any conditional sale and any financing
lease having substantially the same economic effect as any of the foregoing).
1.1.125    “Losses” means liabilities, losses, costs, damages, fees or expenses
(including reasonable legal expenses and attorneys’ fees) payable to a Third
Party.
1.1.126    “Major Market Country” means each or any (as applicable) of the
[***].
1.1.127    “Mandatory Recall” means, in the U.S., an FDA-mandated recall
pursuant to 42 U.S.C. §262(d)(1), or in a country outside of the U.S., the
foreign equivalent thereof mandated by the applicable Regulatory Authority.
1.1.128    “Material Adverse Event” means an event occurring after the Effective
Date that has a material adverse effect on [***] provided however, that none of
the following will constitute, or will be considered in determining whether
there has occurred, a Material Adverse Event: (x) changes in laws or regulations
or in the interpretations or
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methods of enforcement thereof; (y) changes in the pharmaceutical or
biotechnology industries in general; or (z) any earthquakes, hurricanes,
tsunamis, tornadoes, floods, mudslides, wildfires or other natural disasters,
weather conditions, sabotage, terrorism, military action or war (whether or not
declared) or other Force Majeure Events.
1.1.129    “Material Anti-Corruption Law Violation” means a violation by a Party
or its Affiliate of an Anti-Corruption Law relating to the subject matter of
this Agreement that would, if it were publicly known, have a material adverse
effect on the other Party or its Affiliate because of its relationship with such
Party.
1.1.130    “Material Impact” has the meaning ascribed to such term in Section
3.7.
1.1.131    [***].
1.1.132    [***].
1.1.133    “MHRA” means the Medicines and Healthcare products Regulatory Agency.
1.1.134    “Multiplier on Invested Capital” or “MoIC” means (a) 2.5x for
Vutrisiran Development Costs (subject to Section 6.1.1.3(ii)), (b) 3.25x for
ALN-AGT Phase 2 Development Costs (subject to Section 6.1.2.2(ii)), and (c) 4.5x
for ALN-AGT Phase 3 Development Costs (subject to Section 6.1.3.2(ii)).
1.1.135    “NDA” means a new drug application, including a supplement to a new
drug application, submitted to FDA or similar application or supplemental
application submitted to a Regulatory Authority outside of the U.S. for the
purpose of obtaining Regulatory Approval to market and sell a Product.
1.1.136    “Net Sales” means, for any period and for any country, the total
aggregate amount billed during such period in such country by Alnylam, its
Affiliates or sublicensees in such country for all sales of Vutrisiran to Third
Parties (other than to a sublicensee of Alnylam or its Affiliates) after
deducting, if not previously deducted, from the amount invoiced or received, the
following deductions to the extent actually applied or taken with respect to
such sales of Vutrisiran:
[***]
Such amounts deducted from Alnylam’s gross sales of Vutrisiran will be
determined from Alnylam’s books and records that are maintained in accordance
with GAAP, applied on a consistent basis.
If Vutrisiran is sold as a Combination Product, the Net Sales from the
Combination Product, for the purposes of determining milestones and royalties,
shall be determined by multiplying
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the Net Sales of the Combination Product during the applicable Calendar Quarter,
by the fraction, A/(A+B), where A is the average sale price of Vutrisiran when
sold separately in finished form and B is the average sale price of the other
active compounds or active ingredients included in the Combination Product when
sold separately in finished form, in each case during the applicable Calendar
Quarter or, if sales of both Vutrisiran and the other active compounds or active
ingredients did not occur in such period, then in the most recent Calendar
Quarter in which sales of both occurred. If such average sale price cannot be
determined for both Vutrisiran and all other active compounds or active
ingredients included in the Combination Product, Net Sales for the purposes of
determining milestones and royalties shall be calculated by multiplying the Net
Sales of the Combination Product by the fraction of C/(C+D) where C is the fair
market value of Vutrisiran and D is the fair market value of all other active
compounds or active ingredients included in the Combination Product. In such
event, Alnylam will in good faith make a determination of the respective fair
market values of Vutrisiran and all other active compounds or active ingredients
included in the Combination Product (provided that such determination shall be
no less favorable to Blackstone than the corresponding determination made under
[***]), and shall notify Blackstone of such determination and provide Blackstone
with Alnylam’s basis for such determination. If Blackstone in good faith does
not agree with such determination, Blackstone shall give Alnylam written notice
of its disagreement within [***] after receiving the relevant report pursuant to
Section 14.3, and the provisions of Section 14.10 shall apply.
Sales between or among Alnylam and its Affiliates and sublicensees shall be
excluded from the computation of Net Sales, but Net Sales shall include sales to
the first Third Party (other than a sublicensee of Alnylam or its Affiliate)
thereafter by Alnylam or its Affiliates or sublicensees.
1.1.137    “Orange Book Patents” means the Patents listed for a Product in the
FDA’s Orange Book pursuant to 21 U.S.C. §355(b)(1), as such patent listing may
be amended from time to time, together with all foreign counterpart Patents.
1.1.138    “Party” or “Parties” has the meaning ascribed to such term in the
Preamble.
1.1.139    “Patent” will mean patents, patent applications, patent disclosures,
and all related continuations, continuations-in-part, divisionals, reissues,
re-examinations, substitutions, and extensions thereof.
1.1.140    “Paying Party” has the meaning ascribed to such term as in
Section 6.5.2.1.
1.1.141    “Permitted Liens” means (a) the Existing Licenses, (b) any license
agreement entered into by Alnylam after the Effective Date, subject to Section
3.7, (c) Liens with regard to the ALN-AGT Collateral and the Vutrisiran
Collateral pursuant to the Term Loan Agreement and the Intercreditor Agreement,
(d) Liens in favor of banking or
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other financial institutions or entities maintaining a Development Costs Account
permitted under a Deposit Account Control Agreement, and (e) Liens in favor of
Blackstone.
1.1.142    “Permitted Third Party” means any CRO, Site, Clinical Investigator or
Vendor to whom Alnylam has delegated responsibility or whom Alnylam has engaged
in connection with the Clinical Trial Activities or any CMO whom Alnylam has
engaged to perform CMC related activities (including supply of Product for use
in the Product Clinical Trials). For clarity, Third Parties that have been
delegated responsibility by or engaged by a Permitted Third Party will be
considered Permitted Third Parties.
1.1.143    “Person” means any individual, corporation, general or limited
partnership, limited liability company, joint venture, estate, trust,
association, organization, labor union, or other entity or Governmental
Authority.
1.1.144    “Phase 1 Clinical Trial” means any clinical trial as described in 21
C.F.R. §312.21(a), or, with respect to a jurisdiction other than the U.S., a
similar clinical trial.
1.1.145    “Phase 1 Success Criteria” means, with respect to the Phase 1
Clinical Trial for ALN-AGT, acceptable safety, efficacy and pharmacodynamic/
pharmacokinetic results for such Phase 1 Clinical Trial for ALN-AGT relative to
the planned Phase 2 Clinical Trials for ALN-AGT.
1.1.146    “Phase 2 Clinical Trial” means any clinical trial as described in 21
C.F.R. §312.21(b), or, with respect to a jurisdiction other than the U.S., a
similar clinical trial.
1.1.147    “Phase 2 Success Criteria” means with respect to a Phase 2 Clinical
Trial for ALN-AGT, (a) [***] or (b) [***] provided that, in each case of (a) and
(b) [***].
1.1.148    “Phase 3 Clinical Trial” means any clinical trial as described in 21
C.F.R. §312.21(c) (as amended from time to time), or, with respect to a
jurisdiction other than the U.S., a similar clinical trial, which clinical trial
is intended to generate sufficient data and results (together with data from any
prior clinical trials conducted for the applicable Product) to support the
filing of an NDA for such Product.
1.1.149    “Phase 3 Success Criteria” means, (a) [***] or (b) [***]; provided
that, in each case of (a) and (b), as applicable, [***].
1.1.150    “Phase 3 Clinical Trial Protocol” has the meaning ascribed to such
term in Section 2.2.1.
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1.1.151    “PMDA” means the Pharmaceuticals and Medical Devices Agency of Japan
or any successor agency thereto in Japan having substantially the same function.
1.1.152    “Product” or “Products” means, as applicable, either or both of
Vutrisiran and ALN-AGT.
1.1.153    “Product Clinical Trial” means a Clinical Trial for a Product that is
included in a Development Program for such Product. For clarity, with respect to
Vutrisiran, “Product Clinical Trial” will include the HELIOS-B Trial.
1.1.154    “Product Patents” has the meaning ascribed to such term in Section
12.2.10.
1.1.155    “Protocol” means, with respect to a Product Clinical Trial, the
documentation describing the objective, design, methodology, statistical
considerations and organization of such Product Clinical Trial.
1.1.156    “Receiving Party” has the meaning ascribed to such term in Section
9.1.
1.1.157    “Recipient Party” has the meaning ascribed to such term in Section
6.5.2.1.
1.1.158    “Regulatory Approval” means the approval of an NDA for a Product: (a)
by the FDA in the U.S.; (b) by the EMA in the EU; (c) by the MHRA in the United
Kingdom; or (d) by the PMDA in Japan. For clarity, “Regulatory Approval”
excludes any pricing or reimbursement approval that may be necessary or useful
for marketing or sale of a Product in any country or regulatory jurisdiction.
1.1.159    “Regulatory Authority” means, in a particular country or regulatory
jurisdiction, any applicable Governmental Authority involved in authorizing an
IND to initiate or conduct clinical testing in humans or involved in granting
Regulatory Approval, including FDA, EMA, MHRA and the PMDA.
1.1.160    “Removal Effective Date” has the meaning ascribed to such term in
Section 7.5.6.1.
1.1.161    “Required Investors” means, at any time, one or more of the
Blackstone Entities having funded more than [***] of the aggregate Vutrisiran
Development Costs and ALN-AGT Development Costs as of such time under this
Agreement.
1.1.162    “Research Results” means all Information arising out of or resulting
from the Product Clinical Trials and the CMC activities contemplated by the
Development Programs, including the Clinical Trials Database.
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1.1.163    “Resignation Effective Date” has the meaning ascribed to such term in
Section 7.5.6.1.
1.1.164    “Representatives” means, with respect to a Party, such Party’s
Affiliates, and its and their respective officers, directors, employees, agents,
representatives, consultants, and, as applicable, its Permitted Third Parties
engaged in connection with the subject matter of this Agreement.
1.1.165    “Royalty” has the meaning ascribed to such term in Section 6.1.1.2.
1.1.166    “Royalty Term” means the period commencing with a commercial sale of
Vutrisiran giving rise to Net Sales following the first Regulatory Approval of
Vutrisiran for the Approval Indication and ending on the date that is [***]
years thereafter.
1.1.167    “Secured Parties” means, collectively, the Administrative Agent and
Blackstone.
1.1.168    “Serious Safety Issue” means any SUSAR or series of SUSARs directly
related to or caused by the administration of a Product in the conduct of a
Product Clinical Trial where [***].
1.1.169    “Shared IP” means Patents, Copyrights, Trademarks, trade secrets and
other intellectual property recognized under Applicable Law that are necessary
for, and material to, the research, Development, Manufacture, Commercialization,
or other exploitation of any product or program of Alnylam other than ALN-AGT
and Vutrisiran.
1.1.170    “Site” has the meaning ascribed to such term in Section 3.1.3.
1.1.171    [***].
1.1.172    “Success Criteria” means, as applicable, each of the Phase 1 Success
Criteria, the Phase 2 Success Criteria or the Phase 3 Success Criteria.
1.1.173    “Success Payments” means, as applicable, any or all of the Vutrisiran
Success Payments, the ALN-AGT Phase 2 Success Payments, or the ALN-AGT Phase 3
Success Payments.
1.1.174    “Success Payment Trigger” means, as applicable, the Vutrisiran
Success Payment Trigger, the ALN-AGT Phase 2 Success Payment Trigger, or the
ALN-AGT Phase 3 Success Payment Trigger.
1.1.175    “SUSAR” means a suspected unexpected serious adverse reaction,
without regard to causality, that is life-threatening (i.e., causes an immediate
risk of
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death) or that results in any of the following outcomes: death; in-patient
hospitalization or prolongation of existing hospitalization; persistent or
significant disability or incapacity (i.e., substantial disruption of the
ability to conduct normal life functions); or a congenital anomaly or birth
defect. For clarity, a planned medical or surgical procedure is not, in itself,
a SUSAR.
1.1.176    “Term Loan Agreement” means that certain Credit Agreement dated as of
April 10, 2020, among Alnylam, the Guarantors (as defined in the Term Loan
Agreement), the Lenders (as defined in the Term Loan Agreement) and Wilmington
Trust, National Association, as amended, restated, or otherwise modified from
time to time.
1.1.177    “Term” has the meaning ascribed to such term in Section 13.1.
1.1.178    “Third Party” means any Person other than Alnylam, Blackstone and
their Affiliates.
1.1.179    “Third Party Infringement” means any actual or threatened
infringement, misappropriation, or other violation by a Third Party of any
Intellectual Property Controlled by Alnylam that relates to this Agreement or a
Product, including the Trial Inventions.
1.1.180    “Timeline” has the meaning ascribed to such term in Section 2.4.
1.1.181    “Trademarks” means, collectively, all registered and unregistered
marks, trade dress rights, logos, taglines, slogans, Internet domain names, web
addresses, and other indicia of origin, together with the goodwill associated
with any of the foregoing, and all applications, registrations, extensions and
renewals thereof, selected for use on a Product.
1.1.182    “Transaction Agreements” means, collectively, this Agreement, the
Deposit Account Control Agreement, the IP Security Agreements and the
Intercreditor Agreement.
1.1.183    “Trial Invention” has the meaning set forth in Section 10.1.1.3.
1.1.184    “UCC” means the Uniform Commercial Code, as the same may, from time
to time, be enacted and in effect in the State of Delaware; provided, that, to
the extent that the UCC is used to define any term herein and such term is
defined differently in different Articles or Divisions of the UCC, the
definition of such term contained in Article or Division 9 will govern; and
provided further, that in the event that, by reason of mandatory provisions of
law, any or all of the attachment, perfection or priority of, or remedies with
respect to, the Blackstone Security Interest on any Blackstone Collateral is
governed by the Uniform Commercial Code in effect in a jurisdiction other than
the State of Delaware, the term “UCC” will mean the Uniform Commercial Code as
enacted and in effect in such other
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jurisdiction solely for purposes of the provisions thereof relating to such
attachment, perfection, priority or remedies and for purposes of definitions
relating to such provisions.
1.1.185    “United Kingdom” means Great Britain and Northern Ireland.
1.1.186    “U.S.” or “USA” means the United States of America, its territories
and possessions, including Puerto Rico.
1.1.187    “Vendor(s)” has the meaning ascribed to such term in Section 2.5.
1.1.188    “Vutrisiran” means the investigational RNAi therapeutic product also
known as ALN-TTRsc02 that targets transthyretin, which, as of the Effective
Date, is being Developed by Alnylam, as further described on Exhibit A-2 hereto,
in any form, formulation, dose or dosage form, including any salt thereof, under
any brand name or as a generic product.
1.1.189    “Vutrisiran Approval Target” has the meaning ascribed to such term in
Section 6.2.1.2.
1.1.190    [***].
1.1.191    “Vutrisiran Collateral” means all of Alnylam’s right, title and
interest (excluding any leasehold interest) in, to and under the Vutrisiran
Product IP, whether now owned or existing or hereafter arising or acquired,
including, but not limited to, the Alnylam Intellectual Property set forth in
Schedule 7.1.1(b) hereto, and all proceeds related to any of the foregoing.
1.1.192    “Vutrisiran Development Costs” has the meaning ascribed to such term
in Section 4.1.1.
1.1.193    “Vutrisiran Development Plan” means a written plan for the Vutrisiran
Development Program, the initial version of which is attached hereto as Exhibit
B-2, and which will be subject to amendment by the JSC from time to time during
the Development Term.
1.1.194    “Vutrisiran Development Program” means the development program to be
undertaken by the Parties to Develop Vutrisiran that includes the CMC, clinical
and regulatory strategy for Vutrisiran (including the Clinical Trials to be
conducted by Alnylam for Vutrisiran).
1.1.195    “Vutrisiran Maximum Development Costs” has the meaning ascribed to
such term in Section 4.1.
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1.1.196    “Vutrisiran Product IP” means any and all (i) Patents, Copyrights,
Trademarks, trade secrets and other intellectual property recognized throughout
the world under Applicable Law, including the Orange Book Patents, (other than
Patents, Copyrights, Trademarks, trade secrets and other intellectual property
recognized under Applicable Law consisting of RPA Assets (as defined in the Term
Loan Agreement as in effect on the date hereof)) that are necessary for, and
material to, the research, Development, manufacture, Commercialization, or other
exploitation of Vutrisiran, in each case, during the term of this Agreement,
(ii) all income, royalties, damages or payments now or hereafter due and/or
payable under any of the foregoing or with respect to any of the foregoing,
including, without limitation, damages or payments for past, present or future
infringements, violations or misappropriations of any of the foregoing, (iii)
the right to sue for past, present and future infringements, violations or
misappropriations of any of the foregoing, (iv) any Regulatory Approval of
Vutrisiran and (v) all rights corresponding to any of the foregoing throughout
the world; provided, however, that clause (i) shall not include any Shared IP.
1.1.197    “Vutrisiran Success Payments” has the meaning ascribed to such term
in Section 6.1.1.1.
1.1.198    “Vutrisiran Success Payment Trigger” has the meaning ascribed to such
term in Section 6.1.1.1.
1.1.199    “Withholding Party” has the meaning ascribed to such term in
Section 6.5.2.2.
1.2    Construction. For purposes of this Agreement: (1) words in the singular
will be held to include the plural and vice versa as the context requires; (2)
the words “including” and “include” will mean “including, without limitation,”
unless otherwise specified; (3) the terms “hereof,” “herein,” “herewith,” and
“hereunder,” and words of similar import will, unless otherwise stated, be
construed to refer to this Agreement as a whole and not to any particular
provision of this Agreement; (4) all references to “Section” and “Exhibit,”
unless otherwise specified, are intended to refer to a Section or Exhibit of or
to this Agreement; (5) the term “or” will be interpreted in the inclusive sense
commonly associated with the term “and/or”, (6) words of the masculine, feminine
or neuter gender will mean and include the correlative words of other genders;
(7) unless otherwise specified, references to an agreement or other document
include references to such agreement or document as from time to time amended,
restated, reformed, supplemented or otherwise modified in accordance with the
terms hereof, and include any annexes, exhibits and schedules attached thereto;
(8) reference to any Applicable Law will include such Applicable Law as from
time to time in effect, including any amendment, modification, codification,
replacement or reenactment thereof or any substitution therefor; (9) references
to any Person will be construed to include such Person’s successors and
permitted assigns (subject to any restrictions on assignment, transfer or
delegation set forth herein), and any references to a Person in a particular
capacity excludes such Person in other capacities; (10) in the computation of a
period of time from a specified date to a later specified date, the word “from”
means “from and including” and
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each of the words “to” and “until” means “to but excluding;” and (11) where any
payment is to be made, any funds are to be applied or any calculation is to be
made under this Agreement on a day that is not a Business Day, unless this
Agreement otherwise provides, such payment will be made, such funds will be
applied and such calculation will be made on the succeeding Business Day, and
payments will be adjusted accordingly.
1.3    Conflicts. In the event of any conflict between the terms of this
Agreement, the Protocol or any other Exhibit, the Protocol will control (as
applicable), followed by the terms of this Agreement, and followed by any
applicable other Exhibit.
ARTICLE 2
THE DEVELOPMENT PROGRAM
2.1    The Development Programs.
2.1.1    Efforts. Alnylam will use Commercially Reasonable Efforts to conduct
and complete the Vutrisiran Development Program and the ALN-AGT Development
Program at its sole expense (subject to Section 4.1) in accordance with this
Agreement.
2.1.2    Compliance with Laws. Alnylam will perform its Development obligations
in compliance with all Applicable Laws in all material respects.
2.2    The Protocols.
2.2.1    The Protocols.
2.2.1.1 Vutrisiran. The Protocol for the HELIOS-B Trial (the “HELIOS-B
Protocol”) existing on the Effective Date, which is named “Clinical Study
Protocol ALN-TTRSC02-003” and dated as of 22 August 2019, has been provided to
Blackstone.
2.2.1.2 ALN-AGT. The Protocol for each Product Clinical Trial included in the
ALN-AGT Development Program will be prepared by Alnylam using Commercially
Reasonable Efforts and will be reviewed and discussed by the JSC in accordance
with Section 5.1.
2.2.2    Protocol Approval. Alnylam will be responsible for obtaining all
necessary approvals for the applicable Protocols prior to commencing a Product
Clinical Trial. Each Party will reasonably cooperate with the other in such
regard.
2.3    Sponsor.
2.3.1    Sponsorship and Responsibilities. Alnylam or its agent or licensee will
be the sponsor of the Product Clinical Trials, and will have all
responsibilities of a sponsor as specified in Applicable Laws.
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2.3.2    Compliance with the Protocol. Alnylam will use Commercially Reasonable
Efforts to conduct all Product Clinical Trials and perform all other
responsibilities assigned to it hereunder in connection with any such Product
Clinical Trial in compliance with the applicable Protocol.
2.4    Timeline. A good faith, non-binding estimate of the timeline for
conducting the Product Clinical Trials under each Development Program, together
with a non-binding budget for each Development Program that provides such detail
consistent with Alnylam’s standard practices, is attached as Exhibit D hereto
(the “Timeline”). Alnylam will update the Timeline from time-to-time during the
Development Term to reflect any material updates, and will report such revisions
to the JSC in accordance with Section 5.2.1.6. At the next scheduled meeting of
the JSC in accordance with the first sentence of Section 5.1.3, Alnylam will
update the JSC regarding the completion or achievement of events or activities
set forth in the Timeline, as applicable. In the event of any material delays in
activities set forth in the Timeline, the Parties will discuss through the JSC
necessary updates to the funding schedule for the applicable Development Program
set forth in Section 4.3
2.5    CROs and Vendors. Alnylam may delegate any of its responsibilities
described in Section 2.3 to its Affiliates (subject to Section 14.1) and CROs.
Alnylam will use Commercially Reasonable Efforts to cause each of its CROs to
perform the responsibilities delegated to each such CRO in material compliance
with the applicable Protocol and all Applicable Laws. Alnylam will be permitted
to contract for services, equipment, tools, materials or supplies required for
the Product Clinical Trials or Regulatory Approval with any of its Affiliates,
CMOs or other Third Party providers (each, a “Vendor”).
2.6    Responsibility. Alnylam will remain responsible for all of its
obligations under this Agreement, notwithstanding any delegation to an Affiliate
or a CRO or any contracting to a Vendor. Alnylam will use Commercially
Reasonable Efforts to oversee the services of its Affiliates and any CRO or
Vendor utilized to provide services hereunder.
2.7    Reasonable Assistance. Promptly following the Effective Date during the
Development Term, should Blackstone have any questions directly pertaining to
such Protocols and Products, the Blackstone Alliance Manager will direct said
questions to the Alnylam Alliance Manager. The Alnylam Alliance Manager will
promptly coordinate the response to such questions received from Blackstone in
accordance with the foregoing sentence, and, to the extent necessary to respond
to Blackstone’s questions, Alnylam will make available one (1) or more
individuals at reasonable times during normal business hours for the purpose of
assisting in responding to Blackstone’s questions.

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ARTICLE 3
DEVELOPMENT PROGRAM RESPONSIBILITIES
3.1    Conduct of Clinical Trials.
3.1.1    Responsibility. Alnylam will have sole responsibility for the conduct
of the Product Clinical Trials, in consultation with the JSC.
3.1.2    Compliance. Alnylam will conduct the Development Programs and perform
all of its duties and responsibilities hereunder in accordance with the
Development Plans and in compliance with all Applicable Laws in all material
respects. Alnylam will use Commercially Reasonable Efforts to oversee the
manufacture of the Products, and comply (and require that all Permitted Third
Parties of Alnylam comply) with all Applicable Laws with respect to the
research, development, manufacture, testing, analysis, labeling, storage,
handling, disposal, transfer and use of the Products in all material respects.
3.1.3    Sites and Clinical Investigators. Alnylam will be solely responsible
for selecting the study sites to conduct the Product Clinical Trials. Alnylam
will use Commercially Reasonable Efforts to enter, or to cause its Affiliates or
CROs to enter, as applicable, into an agreement with each study site (“Clinical
Trial Agreement” and upon execution of such Clinical Trial Agreement, such study
site will be deemed a “Site”) on commercially reasonable and customary terms,
consistent with industry standards for similar agreements.
3.1.4    Data Collection and Data Management.
3.1.4.1 CRF. Alnylam will be solely responsible for preparing the form of CRF
for the Product Clinical Trials in accordance with the applicable Protocol.
3.1.4.2 Clinical Trials Database; Registries. Alnylam will be responsible for
establishing and maintaining a Clinical Trial database for the data collected
from each Site for the Product Clinical Trials (the “Clinical Trials Database”).
Alnylam will be responsible for registering, maintaining and updating any
registries pertaining to the Product Clinical Trials to the extent required by
any Applicable Laws, including www.clinicaltrials.gov,
www.clinicalstudyresults.org, and the PHRMA Website Synopsis, as applicable.
3.1.5    IRBs and Other Ethics Committees. Alnylam will be solely responsible
for (a) obtaining the approval of the IRBs and other ethics committees required
prior to commencing, and during, the Product Clinical Trials at every Site, and
responding to all queries from all IRBs and other ethics committees, (b)
ensuring that IRBs and such other relevant ethics committees have current
registrations and accreditations, and (c) providing all
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ethics committees, including all IRBs, and Regulatory Authorities, with all
necessary documentation prior to, and during the course of, the Product Clinical
Trials.
3.1.6    Completion of the Clinical Trials; Final CSR. Alnylam will use
Commercially Reasonable Efforts to keep the Sites participating in the Product
Clinical Trials operational, as reasonably necessary or desirable to complete
the Development Programs. The CSR for any Product Clinical Trial will be
prepared by Alnylam, and will comply with all Applicable Laws in all material
respects, including ICH E3 guidelines. The final, signed CSR for any Product
Clinical Trial will be provided to the JSC promptly following the Completion
Date of each such Product Clinical Trial. If there are any additional material
safety or efficacy data pertaining to such Product Clinical Trial that come into
the possession of Alnylam after it has provided Blackstone with the final
Clinical Trial CSR, Alnylam will prepare and promptly provide Blackstone with a
supplement to such CSR.
3.2    Audits.
3.2.1    By Alnylam. Alnylam will use Commercially Reasonable Efforts to conduct
quality oversight inspections and audits of the facilities and services of the
Permitted Third Parties utilized by Alnylam, and will conduct quality oversight
inspections and audits of the manufacturing facilities for the Products in
accordance with its internal policies.
3.2.2    Remediation. Alnylam will use Commercially Reasonable Efforts to
remediate (or have the applicable Permitted Third Party remediate) any material
deficiencies identified in any such inspection or audit that are confirmed by
Alnylam, within [***] following such confirmation. Any such remediation efforts
shall, as between the Parties, be at Alnylam’s cost and expense.
3.3    Product.
3.3.1    Supply of the Product. Alnylam or its Affiliate will be the
manufacturer of the Products for the Product Clinical Trials, either directly or
through a Vendor, and will use Commercially Reasonable Efforts to ensure (a) a
supply of the Products sufficient for the conduct of the Product Clinical
Trials, and (b) that such supply conforms in all material respects to the
applicable release specifications that are necessary to conduct such Product
Clinical Trials.
3.3.2    Product Complaints. Alnylam will be solely responsible for, and will
use Commercially Reasonable Efforts to investigate and resolve, complaints
related to the Products, including complaints pertaining to the manufacturing,
appearance or general physical characteristics of the Products or other
processes at the manufacturing facility.
3.4    Pharmacovigilance and Safety Information Exchange. Alnylam will promptly
(but in any event within [***] of Alnylam’s actual awareness thereof) report to
the JSC any
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Serious Safety Issue for (a) Product Clinical Trial subjects who receive a
Product, or (b) individuals otherwise exposed to a Product.
3.5    Product Recalls. Alnylam will be solely responsible for the operational
execution of any recall of a Product; provided that, Alnylam will inform the JSC
regarding the decision to initiate any such recall. The costs for any such
recall will be at Alnylam’s sole cost and expense, and, with respect to
Vutrisiran, except with respect to the cost of any replacement Product
associated with any such recall, such costs shall not be subject to deduction
from Net Sales in the calculation of the Royalty owed to Blackstone pursuant to
Section 6.1.1.2.
3.5.1    Conduct of Clinical Trials. Alnylam will use Commercially Reasonable
Efforts to complete the Product Clinical Trials in accordance with the Timeline,
as such Timeline may be revised from time-to-time in accordance with Section
2.4.
3.5.2    Regulatory Approval. Upon achievement of the Phase 3 Success Criteria
for each Product, Alnylam will use Commercially Reasonable Efforts to obtain
Regulatory Approval for such Product in the U.S. or EU, including filing an NDA
for such Product with the applicable Regulatory Authority within [***] of the
date of achievement of the Phase 3 Success Criteria for such Product. In the
event that Alnylam fails to use Commercially Reasonable Efforts to so obtain
Regulatory Approval for a Product, including the obligation to file an NDA for a
Product within [***] of the date of achievement of the Phase 3 Success Criteria
for such Product, and this failure is not cured as set forth in Section 13.3.1,
Blackstone may terminate this Agreement pursuant to Section 13.3.1.
3.5.3    Commercialization. Following the achievement of Regulatory Approval of
a Product in any country in the Major Market Countries, Alnylam will use
Commercially Reasonable Efforts to Commercialize such Product in such country.
3.6    Disclosures by Alnylam. Promptly following the Effective Date and
thereafter during the Development Term, Alnylam will promptly provide Blackstone
with copies of information or documents relating to [***]. For clarity, Alnylam
will remain the sole owner of, and will retain all right, title and interest in,
to and under all such documents and information, and such documents and
information will be Alnylam Confidential Information.
3.7    Licensing Transactions. Prior to entering into a Licensing Transaction
other than an Excluded Licensing Transaction in any of the Major Market
Countries, Alnylam will provide Blackstone with written notice of such proposed
Licensing Transaction that includes a non-binding term sheet or comparable
document summarizing the material terms of the such proposed Licensing
Transaction to the JSC; provided, however, that Alnylam may redact or withhold
such information in its reasonable discretion to protect proprietary or
competitively sensitive information, or any information protected by
attorney-client or other similar privilege. If Blackstone believes that such
Licensing Transaction would [***] (a “Material Impact”), Blackstone will provide
a written notice to Alnylam with respect thereto
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that sets forth the basis for Blackstone’s belief as to a Material Impact within
[***] of Blackstone’s receipt of Alnylam’s written notice with respect to such
Licensing Transaction in accordance with this Section 3.7. The Executive
Officers will promptly confer to discuss such dispute. If the Executive Officers
are unable to resolve such dispute within [***] of the date of Alnylam’s receipt
of Blackstone’s written notice under this Section 3.7, then the dispute will be
submitted to binding arbitration for resolution before a single neutral
arbitrator under the American Arbitration Association’s (“AAA”) expedited
arbitration rules, which arbitrator will be mutually agreeable to both Parties
and have significant expertise on the subject matter to be decided (provided
that if the Parties have not mutually agreed on such arbitrator within [***]
after the submission of such dispute for arbitration, the AAA will designate
such arbitrator), such arbitration to be concluded and the arbitrator’s award to
be rendered within [***] of the submission of the dispute for arbitration. The
sole issue to be decided in the arbitration will be whether such Licensing
Transaction by Alnylam would have a substantial likelihood of having a Material
Impact. In the event the arbitrator determines that such Licensing Transaction
by Alnylam would have a substantial likelihood of having a Material Impact,
Blackstone may within [***] exercise its right to terminate this Agreement under
Section 13.3.5, provided that if Blackstone elects to continue this Agreement or
does not exercise its right to terminate under Section 13.3.5, this Agreement
will remain in full force and effect without modification. In the event the
arbitrator determines that such Licensing Transaction by Alnylam would not have
a substantial likelihood of having a Material Impact, this Agreement will remain
in full force and effect without modification.
3.8    Change of Control. Following a Change of Control, Alnylam will provide
Blackstone with written notice of such Change of Control within [***]. In the
event that Blackstone believes that such Change of Control would have a
substantial likelihood of having a Material Impact, Blackstone will provide a
written notice to Alnylam with respect thereto that sets forth the basis for
Blackstone’s belief as to a Material Impact within [***] of Blackstone’s receipt
of Alnylam’s written notice with respect to such Change of Control in accordance
with this Section 3.8. The Executive Officers will promptly confer to discuss
such dispute. In the event that the Executive Officers are unable to resolve
such dispute within [***] of the date of Alnylam’s receipt of Blackstone’s
written notice under this Section 3.8, then [***]. In the event that, in
accordance with the foregoing, it is determined that such Change of Control of
Alnylam would have a substantial likelihood of having a Material Impact,
Blackstone may within [***] exercise its right to terminate this Agreement under
Section 13.3.5, provided that if Blackstone elects to continue this Agreement or
does not exercise its right to terminate under Section 13.3.5, this Agreement
will remain in full force and effect without modification. In the event that it
is determined that such Change of Control by Alnylam would not have a
substantial likelihood of having a Material Impact (or Blackstone otherwise does
not exercise its right to terminate this Agreement), then this Agreement will
remain in full force and effect without modification.
3.9    [***]
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ARTICLE 4
DEVELOPMENT COSTS
4.1    Development Costs.
4.1.1    Vutrisiran. Blackstone will pay up to a cap of Seventy Million U.S.
Dollars ($70,000,000) of Development Costs for the HELIOS-B Trial (such costs,
the “Vutrisiran Development Costs” and such cap, the “Vutrisiran Maximum
Development Costs”) in accordance with the funding schedule set forth in Section
4.3. For clarity, (a) Blackstone will be entitled to invest the Vutrisiran
Development Costs (up to the Vutrisiran Maximum Development Costs) in an amount
equal to Alnylam’s Development expenses for Vutrisiran during the Development
Term for Vutrisiran (which Development expenses will be provided to Blackstone
through the JSC), and (b) Alnylam agrees not to use additional funding from a
Third Party for the Development of Vutrisiran until the Vutrisiran Maximum
Development Costs have been provided to Alnylam by Blackstone. Notwithstanding
the foregoing, in the event that the Vutrisiran Development Costs actually
exceed the payments made by Blackstone under this Section 4.1.1 (including as a
result of certain Development Events not yet having been achieved pursuant to
Section 4.3), then Alnylam may use additional funding from a Third Party for the
Development of Vutrisiran to cover any such shortfall in funding; provided that,
if such shortfall is a result of a Development Event not yet having been
achieved, then Alnylam may only seek such Third Party funding for the
Development Costs payable under the Funding Tranche corresponding to such
Development Event; and provided further, that regardless of whether Alnylam
utilizes such Third Party funding, Blackstone will remain entitled to invest an
amount up to the Vutrisiran Maximum Development Costs, such that the total
amount of Alnylam’s Development expenses for Vutrisiran during the Development
Term set forth in the foregoing (a) will not be reduced by the amount of such
Third Party funding. As between the Parties, any Development Costs in excess of
the Vutrisiran Maximum Development Costs will be borne by Alnylam.
4.1.2    ALN-AGT. Subject to Section 4.2, Blackstone will pay up to (a)
Twenty-Six Million U.S. Dollars ($26,000,000) of Development Costs for the
ALN-AGT Phase 2 Trial (the “ALN-AGT Phase 2 Development Costs”), and (b)
Fifty-Four Million U.S. Dollars ($54,000,000) for the ALN-AGT Phase 3 Trial (the
“ALN-AGT Phase 3 Development Costs”) (together with the ALN-AGT Phase 2
Development Costs, the “ALN-AGT Development Costs,” and the cost caps therein,
the “ALN-AGT Maximum Development Costs”) in accordance with the funding schedule
set forth in Section 4.3. For clarity, (i) Blackstone will be entitled to invest
the ALN-AGT Development Costs (up to the ALN-AGT Maximum Development Costs) in
an amount equal to Alnylam’s Development expenses for ALN-AGT during the
Development Term for ALN-AGT (which Development expenses will be provided to
Blackstone through the JSC), and (ii) Alnylam agrees not to use additional
funding from a Third Party for the Development of ALN-AGT until the ALN-AGT
Maximum Development Costs have been provided to Alnylam by Blackstone.
Notwithstanding the foregoing, in the event that the ALN-AGT Development Costs
actually
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exceed the payments made by Blackstone under this Section 4.1.2 (including as a
result of certain Development Events not yet having been achieved pursuant to
Section 4.3), then Alnylam may use additional funding from a Third Party for the
Development of ALN-AGT to cover any such shortfall in funding; provided that, if
such shortfall is a result of a Development Event not yet having been achieved,
then Alnylam may only seek such Third Party funding for the Development Costs
payable under the Funding Tranche corresponding to such Development Event; and
provided further, that regardless of whether Alnylam utilizes such Third Party
funding, Blackstone will remain entitled to invest an amount up to the ALN-AGT
Maximum Development Costs, such that the total amount of Alnylam’s Development
expenses for ALN-AGT during the Development Term set forth in the foregoing (i)
will not be reduced by the amount of such Third Party funding. As between the
Parties, any Development Costs in excess of the ALN-AGT Maximum Development
Costs will be borne by Alnylam.
4.2    Contingent Nature of Obligation to Fund ALN-AGT Development Costs.
4.2.1    ALN-AGT Phase 2 Development Costs. Blackstone will have no obligation
to pay to Alnylam the ALN-AGT Phase 2 Development Costs unless and until (a) the
completion of a Phase 1 Clinical Trial for ALN-AGT (or a sufficient portion
thereof) that the Parties mutually agree is supportive of the advancement of
ALN-AGT into a Phase 2 Clinical Trial, and (b) Blackstone’s final determination
that the Phase 1 Success Criteria for such Phase 1 Clinical Trial for ALN-AGT
have been met. In the event that the Parties are unable to so agree on whether
such Phase 1 Clinical Trial is supportive of advancement, or Blackstone
determines that the success criteria for such Phase 1 Clinical Trial have not
been met, then Alnylam may, in its sole discretion, determine to proceed with
the ALN-AGT Phase 2 Trial. Notwithstanding the foregoing, and for the avoidance
of doubt, Blackstone will have the right, but will have no obligation to, pay
the ALN-AGT Phase 2 Development Costs in support of such ALN-AGT Phase 2 Trial.
4.2.2    ALN-AGT Phase 3 Development Costs. Following (a) the completion of the
ALN-AGT Phase 2 Trial, and (b) the JSC’s final determination that the Phase 2
Success Criteria for the ALN-AGT Phase 2 Trial have been met, Blackstone will
have the right (but not the obligation) to fund the ALN-AGT Phase 3 Development
Costs. In the event that the JSC determines that the Phase 2 Success Criteria
for such ALN-AGT Phase 2 Trial have not been met (or the Parties cannot agree
that the Phase 2 Success Criteria have been met), then Alnylam may, in its sole
discretion, determine to proceed with the ALN-AGT Phase 3 Trial. Notwithstanding
the foregoing, and for the avoidance of doubt, (x) Blackstone will have the
right, but will have no obligation to, pay the ALN-AGT Phase 3 Development Costs
in support of such ALN-AGT Phase 3 Trial, and (y) upon achievement of the
ALN-AGT Phase 2 Success Payment Trigger, regardless of whether Blackstone pays
the ALN-AGT Phase 3 Development Costs, Blackstone will still be entitled to
receive the ALN-AGT Phase 2 Success Payments in accordance with the payment
schedule set forth in Section 6.1.2.1 without delay.
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4.3    Funding Schedule.
4.3.1    Vutrisiran. Blackstone will pay the Vutrisiran Development Costs to
Alnylam in Funding Tranches on the basis of Alnylam’s achievement of the
Development Events set forth on Schedule 4.3(a)until the date on which the
Vutrisiran Development Costs reach the Vutrisiran Maximum Development Costs. For
clarity, Blackstone will have no obligation to fund any Funding Tranche of the
Vutrisiran Development Costs unless and until the corresponding Development
Event has been met. With respect to each Funding Tranche, such payments will be
made quarterly within [***] following Blackstone’s receipt of an invoice from
Alnylam for such quarterly payment, which invoice will be issued within [***]
following the start of each Calendar Quarter in the foregoing time period..
4.3.2    ALN-AGT. Blackstone will pay the ALN-AGT Development Costs to Alnylam
in Funding Tranches on the basis of Alnylam’s achievement of the Development
Events set forth on Schedule 4.3(b) hereto (a) with respect to the ALN-AGT Phase
2 Development Costs, until the conclusion of the ALN-AGT Phase 2 Trial (subject
to the applicable ALN-AGT Maximum Development Costs), and (b) with respect to
the ALN-AGT Phase 3 Development Costs, until the conclusion of the ALN-AGT Phase
3 Trial (subject to the applicable ALN-AGT Maximum Development Costs). For
clarity, Blackstone will have no obligation to fund any Funding Tranche of the
Vutrisiran Development Costs unless and until the corresponding Development
Event has been met. With respect to each Funding Tranche, such payments will be
made quarterly within forty-five (45) days following Blackstone’s receipt of an
invoice from Alnylam for such quarterly payment, which invoice will be issued
within ten (10) days following the start of each Calendar Quarter in the
foregoing time periods.
4.4    Use of Proceeds. Alnylam will use the (a) Vutrisiran Development Costs
provided by Blackstone pursuant to Section 4.1 solely for the purposes of
funding the Development and pre-Commercialization costs of Vutrisiran, and (b)
ALN-AGT Development Costs provided by Blackstone pursuant to Section 4.1 solely
for the purposes of funding the Development and pre-Commercialization costs of
ALN-AGT.
4.5    Development Costs Account. The Vutrisiran Development Costs and the
ALN-AGT Development Costs will be funded into, and will be disbursed from, the
Development Costs Account. Alnylam hereby grants a continuing first-priority
security interest in the Development Costs Account to Blackstone to secure
payment of the Alnylam Obligations. Proceeds remaining in the Development Costs
Account at any time after which the Clinical Trials for each Development Program
have been either completed or terminated (as applicable) will be re-funded to
Blackstone.

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ARTICLE 5
GOVERNANCE
5.1    Joint Steering Committee.
5.1.1    Representatives. Within [***] after the Effective Date, the Parties
will establish a joint steering committee to oversee and manage the
collaboration (the “JSC”). Each Party initially will appoint [***]
representatives to serve as representatives to the JSC (the “JSC
Representatives”), with each JSC Representative having knowledge and expertise
regarding developing products similar to the Products and sufficient
decision-making authority within the applicable Party to make decisions on
behalf of such Party within the scope of the JSC’s decision-making authority
and, if any such representative is not an employee of the appointing Party, such
representative will execute a confidentiality agreement in form and substance
acceptable to the other Party (and, for the avoidance of doubt, the appointing
Party will remain responsible to the other Party for any noncompliance by such
representative with such confidentiality obligations). Each Party may replace
its JSC Representatives at any time upon written notice to the other Party.
5.1.2    Chairperson. The JSC chairperson (“JSC Chairperson”) will be designated
by Alnylam from Alnylam’s JSC Representatives. The JSC Chairperson will
coordinate with the Alnylam Alliance Manager for drafting and circulating the
draft agenda and ensuring minutes are prepared, as may be appropriate.
5.1.3    Meetings. From the Effective Date until, on a Product-by-Product basis,
the first quarter after the date on which such Product has obtained Regulatory
Approval (which Regulatory Approval is for the Approval Indication with respect
to Vutrisiran) in the U.S. and at least three additional Major Market Countries,
(after which time, the JSC will be dissolved with respect to such Product or,
after the second Product has met such criteria, will be dissolved in its
entirety), the JSC will meet at least twice per Calendar Year (and for clarity,
such meetings are intended to be conducted via teleconference or
videoconference) unless the Parties mutually agree otherwise. In the event that
[***] either Party may call a special meeting of the JSC (by videoconference or
teleconference) during the Development Term by providing at least [***] prior
written notice to the other Party, which notice will include a reasonably
detailed description of the purpose of such meeting.
5.1.4    Participants. The JSC may invite individuals who are not JSC
Representatives to participate in JSC meetings; provided that (a) all JSC
Representatives of both Parties consent to such non-member’s participation; and
(b) such non-member has executed a confidentiality agreement in form and
substance acceptable to the non-inviting Party (and, for the avoidance of doubt,
the inviting Party will remain responsible to the non-inviting Party for any
noncompliance by such individual with such confidentiality obligations). For
clarity, such non-members will have no voting rights at the JSC.
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5.1.5    Alliance Managers. Each Party will appoint an individual to act as an
alliance manager for such Party (each, an “Alliance Manager”) by providing the
name and contact information for the Alliance Manager to the JSC. Each Party may
change its Alliance Manager from time to time in its sole discretion upon
written notice to the JSC. The Alliance Managers will be the primary point of
contact for the Parties regarding the activities contemplated by the Agreement,
and the Parties will use reasonable efforts to ensure that any requests for
information and data made outside of the JSC are made through the Alliance
Managers. The Alliance Managers will attend all meetings of the JSC, and
coordinate the exchange of information with regard to any of Blackstone’s
reasonable questions about the HELIOS-B Protocol, the Protocols for Product
Clinical Trials for ALN-AGT and the Products, which may be addressed at such
meetings of the JSC, as appropriate. For clarity, the Alliance Managers may also
be members of the JSC, but will remain in place for the duration of the Term,
regardless of whether the JSC is dissolved pursuant to Section 5.1.3.
5.1.6    Costs. Each Party will bear its own expenses relating to the meetings
and activities of the JSC.
5.2    JSC Responsibilities and Decision-Making.
5.2.1    Responsibilities (Review and Discuss). The JSC’s responsibilities will
include reviewing and discussing (but not approving) the following at regularly
scheduled meetings:

5.2.1.1 the progress of the Development Programs and the overall Regulatory
Approval and Commercialization strategies for the Products;
5.2.1.2 material changes in the Development Programs, including material changes
required by, or made to respond to comments from, a Regulatory Authority;
5.2.1.3 the Development Costs incurred in connection with, the Development
Programs;
5.2.1.4 a material change to a Protocol, including (a) a material change to the
statistical analysis plan attached hereto as Exhibit G, (b) a material reduction
of the statistical powering of a Product Clinical Trial as set forth in the
Protocol for such Product Clinical Trial, or (c) any material change to the
inclusion criteria or exclusion criteria with respect to a Product Clinical
Trial as set forth in the applicable Protocol;
5.2.1.5 the substitution or addition of any arms in any Product Clinical Trial;
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5.2.1.6 material changes or revisions to the Timeline for the Product Clinical
Trials;
5.2.1.7 Licensing Transactions between Alnylam and a Third Party that could
materially impact Alnylam’s ability to make the Success Payments in accordance
with Section 3.7;
5.2.1.8 the addition to the Development Program of any new Clinical Trials
testing the efficacy of a Product; and
5.2.1.9 any other matters the Parties mutually agree in writing will be, or are
expressly provided in this Agreement to be, reviewed and discussed by the JSC.
5.2.2    Responsibilities (Review and Approve). The JSC’s responsibilities will
include reviewing and approving the following:
5.2.2.1 changes to the funding schedule set forth in Section 4.3 for either
Vutrisiran or ALN-AGT;
5.2.2.2 the determination as to whether the Phase 2 Success Criteria or the
Phase 3 Success Criteria have been achieved; or
5.2.2.3    any other matters that the Parties mutually agree in writing will be,
or are expressly provided in this Agreement to be, reviewed and approved by the
JSC.
5.2.3    Limitation on Authority. Notwithstanding anything to the contrary set
forth in this Agreement, the JSC will have no authority to (a) amend, modify or
waive compliance with this Agreement, or (b) resolve any dispute concerning the
validity, interpretation, construction of, or breach of this Agreement.
5.2.4    Decision-Making. Alnylam will retain sole decision-making authority
over (a) [***] and (b) [***] except, in each case of (a) and (b), other than the
matters described in Section 5.2.2. The unanimous approval of the JSC will be
required with respect to all matters within its decision-making authority as
described in the foregoing Section 5.2.2. The JSC Representatives of each Party
will collectively have one (1) vote. The presence of at least one of each
Party’s JSC representatives constitutes a quorum for the conduct of business at
any JSC meeting, and no vote of the JSC may be taken without a quorum present.
If the Parties are unable to reach agreement with regard to any of the matters
set forth in Section 5.2.2, then, the matter will be escalated to the Executive
Officers for attempted resolution by good faith negotiations during a period of
[***] or as may be extended by mutual agreement of the Parties. If,
notwithstanding such good faith negotiations, the Executive Officers fail to
resolve such matter prior to expiration of such [***] negotiation period, as may
be extended in accordance with the foregoing sentence, with
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respect to a Dispute as to Sections 5.2.2.2 or 5.2.2.3 only, either Party may
initiate an arbitration with respect to such Dispute after expiration of such
[***] negotiation period, in accordance with Section 14.10.2. For the avoidance
of doubt, neither party will be permitted to initiate an arbitration hereunder
with respect to a Dispute as to matters within Section 5.2.2.1.
5.3    Reports.
5.3.1    Provided to the JSC. At each JSC meeting Alnylam will provide an update
and overview on the progress of the Product Clinical Trials and will report
generally on progress toward obtaining Regulatory Approvals in each Major Market
Country. As applicable, such update and overview will address matters that are
subject to review and discussion of the JSC pursuant to Section 5.2.1, and
Alnylam shall promptly provide to the JSC, prior to any JSC meeting at which the
JSC is scheduled to discuss whether the Success Criteria under sub-sections
1.1.145, 1.1.147 or 1.1.149 have been met, those background materials that
Blackstone identifies as reasonably necessary for it to adjudicate such Success
Criteria and its decision to fund ALN-AGT Development Costs. For clarity,
Alnylam shall not be required to prepare any new substantive written materials
for the JSC meeting beyond the written materials that Alnylam is obligated to
disclose to Blackstone pursuant to Section 3.6.
5.3.2    Following JSC Dissolution with Respect to Vutrisiran. Following the
dissolution of the JSC with respect to Vutrisiran (as set forth in Section
5.1.3), Alnylam will provide, on an annual basis, [***]. In addition, following
such dissolution of the JSC, no less than annually, the Alliance Managers will
discuss any material updates to the prosecution and enforcement of the Alnylam
Intellectual Property, the manufacturing and Commercialization of Vutrisiran, or
any other material updates that could reasonably be expected to impact Alnylam’s
obligation to pay the Royalty to Blackstone.
ARTICLE 6
PAYMENTS TO BLACKSTONE
6.1    Success Payments; Royalty.
6.1.1    Vutrisiran.
6.1.1.1 Success Payments. Following Regulatory Approval of Vutrisiran for the
Approval Indication in the first Major Market Country (the “Vutrisiran Success
Payment Trigger”), Alnylam will pay to Blackstone (subject to adjustment
pursuant to Section 6.2) a payment equal to [***] following the end of the
Calendar Quarter in which the Vutrisiran Success Payment Trigger occurs, in
accordance with Section 6.3.1. Thereafter, if and only if the conditions
precedent set forth in Section 6.1.1.3(ii) below are met on the applicable
payment date, Alnylam will make [***] (subject to Section 6.2.1.2) additional
[***] payments of [***] until the second (2nd) anniversary of the Vutrisiran
Success Payment Trigger, for a total
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(including the initial payment above) of One-Hundred and Seventy-Five Million
U.S. Dollars ($175,000,000) (subject to adjustment pursuant to Section 6.2) in
accordance with Section 6.3.1 (all payments under this Section 6.1.1.1, the
“Vutrisiran Success Payments”).
6.1.1.2 Royalty. Alnylam will pay to Blackstone, on a country-by-country basis,
a one percent (1%) royalty on the aggregate Net Sales of Vutrisiran in any
indication sold by Alnylam, its Affiliates or its sublicensees, in such country
during the Royalty Term (the “Royalty”). For the avoidance of doubt, (a) the
Royalty (and the calculation of Net Sales) will not be subject to any offset,
deduction or step-down of any kind, and will be calculated without taking into
account any payments owed to Third Parties under subclause (b) of this Section
6.1.1.2, and (b) Alnylam will bear one hundred percent (100%) of any amounts
paid or payable to Third Parties (including, but not limited to, milestone
payments, royalty payments, sublicensing fees, license maintenance fees, etc.)
as of the Effective Date or at any time during the Term under the Existing
Licenses or any future agreement entered into with a Third Party related to
Vutrisiran.
6.1.1.3 Contingent Payments; Conditions Precedent.
(i)    Failure to Achieve Success Payment Trigger. Subject to the termination
rights set forth in Section 13.3, in the event that the Vutrisiran Success
Payment Trigger is not met, but Alnylam has materially performed its obligations
under this Agreement (including, without limitation, its obligation to use
Commercially Reasonable Efforts as set forth in Section 3.2.2), then Alnylam
will not be obligated to pay the Vutrisiran Success Payments or Royalty to
Blackstone (or any other payments hereunder to Blackstone with respect to
Vutrisiran).
(ii)    Conditions Precedent. Alnylam’s obligation to pay to Blackstone each
Vutrisiran Success Payment set forth in Section 6.1.1.1 above following the
initial Success Payment of [***] (subject to adjustment pursuant to Section 6.2)
will only apply if, as of the applicable Vutrisiran Success Payment date,
Vutrisiran has not been withdrawn from the market, in its entirety and for all
indications, in all Major Market Countries following a Mandatory Recall. In the
event that, following the implementation of a Mandatory Recall, [***] or
Vutrisiran is re-launched in a Major Market Country, then the Vutrisiran Success
Payments will be due and payable by Alnylam to Blackstone in accordance with the
payment schedule set forth in Section 6.1.1.1 above, which payment schedule will
be extended to account for the length of time during which Vutrisiran was
withdrawn from the market; provided that, at the time of such payments for such
[***] re-launched Product, the condition set forth in the foregoing sentence is
met for such [***] re-launched Product; and provided further, that the amount of
such Vutrisiran Success Payments for such [***] re-launched Product will be
reduced by the amount of any Vutrisiran Success Payments that were paid to
Blackstone prior to such Mandatory Recall.
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6.1.2    ALN-AGT Phase 2 Success Payments.
6.1.2.1 Success Payments. Following the earlier of (a) the Parties reasonable
determination through the JSC as of the rand DB PCT IA (as such event is defined
in the ALN-AGT Development Plan) that the Phase 2 Success Criteria for the
ALN-AGT Phase 2 Trial have been met, or (b) Alnylam’s (or its designee’s)
commencement (i.e., first dosing of the first subject) of a Phase 3 Clinical
Trial for ALN-AGT ((a) or (b), as applicable, the “ALN-AGT Phase 2 Success
Payment Trigger”), Alnylam will pay to Blackstone (subject to adjustment
pursuant to Section 6.2) a payment equal to [***] following the end of the
Calendar Quarter in which the ALN-AGT Phase 2 Success Payment Trigger occurs, in
accordance with Section 6.3.1; provided that, in the event that the ALN-AGT
Phase 2 Success Payment Trigger is met on the basis of the foregoing (b), then,
following the commencement of such ALN-AGT Phase 3 Trial, Alnylam shall pay the
amounts set forth in this Section 6.1.2.1 as if the ALN-AGT Phase 2 Success
Trigger had occurred on the date on which the results of the rand DB PCT IA (as
such event is defined in the ALN-AGT Development Plan) for the ALN-AGT Phase 2
Trial were available (including, subject to Section 6.1.2.2(ii), the immediate
payment to Blackstone of any amounts that would have already been due and
payable had the ALN-AGT Phase 2 Success Trigger occurred upon such date).
Thereafter, if and only if the conditions precedent set forth in Section
6.1.2.2(ii) below are met on the applicable payment date, Alnylam will make
[***] (subject to Section 6.2.2.2 and subject to any catch-up payments required
by the proviso in the immediately preceding sentence) additional [***] payments
of [***] until the fourth (4th) anniversary of the ALN-AGT Phase 2 Success
Payment Trigger for a total (including the initial payment above) of Eighty-Four
Million, Five-Hundred Thousand U.S. Dollars ($84,500,000) (subject to adjustment
pursuant to Section 6.2) in accordance with Section 6.3.1 (all payments under
this Section 6.1.2.1, the “ALN-AGT Phase 2 Success Payments”).
6.1.2.2 Contingent Payments; Conditions Precedent.
(i)    Failure to Achieve Success Criteria. In the event that Alnylam has
materially performed its obligations under this Agreement (including its
obligation to use Commercially Reasonable Efforts as set forth in Section
3.2.2), but the ALN-AGT Phase 2 Success Payment Trigger is not met, then Alnylam
will not be obligated to pay the ALN-AGT Phase 2 Success Payments to Blackstone
(or any other payments hereunder to Blackstone with respect to ALN-AGT). For the
avoidance of doubt, in the event that the ALN-AGT Phase 2 Success Payment
Trigger is met, but the ALN-AGT Phase 3 Success Payment Trigger is not met
during the Term, then, Alnylam will only be obligated to pay to Blackstone the
ALN-AGT Phase 2 Success Payments, subject to Section 6.1.2.2(ii).
(ii)    Conditions Precedent. Alnylam’s obligation to pay to Blackstone each
ALN-AGT Phase 2 Success Payment set forth in Section 6.1.2.1 above
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following the initial ALN-AGT Phase 2 Success Payment of [***] (subject to
adjustment pursuant to Section 6.2) will only apply if, as of the applicable
ALN-AGT Phase 2 Success Payment date, (A) Alnylam has not discontinued the
ALN-AGT Development Program in its entirety in all Major Market Countries
following the issuance of a Clinical Hold resulting from a SUSAR, and (B) [***].
In the event that, following the discontinuation of the ALN-AGT Development
Program, [***] or the Development Program for the Existing ALN-AGT Product is
recommenced in a Major Market Country, and such Existing ALN-AGT Product [***]
achieves the Phase 2 Success Criteria, then the ALN-AGT Phase 2 Success Payments
will be due and payable by Alnylam to Blackstone in accordance with the payment
schedule set forth in Section 6.1.2.1 above, which payment schedule will be
extended to account for the length of time during which Alnylam was not
Developing the Existing ALN-AGT Product [***] provided that, at the time of such
payments for such [***] re-launched Product, the conditions set forth in the
foregoing sentence are met for such [***] re-launched Product; and provided
further, that the amount of such ALN-AGT Phase 2 Success Payments for such
ALN-AGT Back-Up Product or re-launched Product will be reduced by the amount of
any ALN-AGT Phase 2 Success Payments that were paid to Blackstone prior to
Alnylam’s discontinuation of the ALN-AGT Development Program.
6.1.3    ALN-AGT Phase 3 Success Payments.
6.1.3.1 Success Payments. Following Regulatory Approval of ALN-AGT in the first
Major Market Country (the “ALN-AGT Phase 3 Success Payment Trigger”), Alnylam
will pay to Blackstone (subject to adjustment pursuant to Section 6.2) a payment
equal to [***] following the end of the Calendar Quarter in which the ALN-AGT
Phase 3 Success Payment Trigger occurs, in accordance with Section 6.3.1.
Thereafter, if and only if the conditions precedent set forth in Section
6.1.3.2(ii) below are met on the applicable payment date, Alnylam will make
[***] (subject to Section 6.2.3.2) additional [***] payments of [***] until the
fourth (4th) anniversary of the ALN-AGT Phase 3 Success Payment Trigger, for a
total (including the initial payment above) of Two-Hundred and Forty-Three
Million U.S. Dollars ($243,000,000) (subject to adjustment pursuant to Section
6.2) in accordance with Section 6.3.1 (all payments under this Section 6.1.3.1,
the “ALN-AGT Phase 3 Success Payments”).
6.1.3.2 Contingent Payments; Conditions Precedent.
(i)    Failure to Achieve ALN-AGT Phase 3 Success Payment Trigger. Subject to
the termination rights set forth in Section 13.3, in the event that Alnylam has
performed its obligations under this Agreement (including its obligation to use
Commercially Reasonable Efforts as set forth in Section 3.2.2), but the ALN-AGT
Phase 3 Success Payment Trigger is not met, then Alnylam will not be obligated
to pay the ALN-AGT Phase 3 Success Payments to Blackstone.
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(ii)    Conditions Precedent. Alnylam’s obligation to pay to Blackstone each
ALN-AGT Phase 3 Success Payment set forth in Section 6.1.3.1 above following the
initial Success Payment of [***] (subject to adjustment pursuant to Section 6.2)
will only apply if, as of the applicable Success Payment date, ALN-AGT has not
been withdrawn from the market, in its entirety and for all indications, in all
Major Market Countries following a Mandatory Recall. In the event that,
following the implementation of a Mandatory Recall [***] or ALN-AGT is
re-launched in a Major Market Country, then Alnylam will resume its payment of
the ALN-AGT Phase 3 Success Payments to Blackstone in accordance with the
payment schedule set forth in Section 6.1.3.1 above, which payment schedule will
be extended to account for the length of time during which ALN-AGT was withdrawn
from the market; provided that, at the time of such payments for such [***]
re-launched Product, the condition set forth in the foregoing sentence is met
for such [***] re-launched Product; and provided further, that the amount of
such ALN-AGT Phase 3 Success Payments for such [***] re-launched Product will be
reduced by the amount of any ALN-AGT Phase 3 Success Payments that were paid to
Blackstone prior to such Mandatory Recall.
6.2    Payment Adjustments.
6.2.1    Vutrisiran.
6.2.1.1 Adjustment for Change in Development Costs. In the event that the actual
Vutrisiran Development Costs paid by Blackstone hereunder are lower or greater
than Seventy Million U.S. Dollars ($70,000,000), then the Vutrisiran Success
Payments will be adjusted to reflect the applicable MoIC multiplied by the
actual Vutrisiran Development Costs paid by Blackstone hereunder. By way of
example, if the actual Vutrisiran Development Costs equal Sixty-Five Million
U.S. Dollars ($65,000,000), then the Vutrisiran Success Payments would be equal
to $65,000,000 x 2.5 = $162,500,000.
6.2.1.2 Adjustment for Regulatory Delay. In the event that the Vutrisiran
Success Payment Trigger has not been achieved by [***] (the “Vutrisiran Approval
Target”), then, unless such delay is caused by a Force Majeure Event, following
the Vutrisiran Success Payment Trigger, the Vutrisiran Success Payments will be
adjusted as follows [***].
6.2.2    ALN-AGT Phase 2 Success Payments.
6.2.2.1 Adjustment for Change in Development Costs. In the event that the actual
ALN-AGT Phase 2 Development Costs paid by Blackstone hereunder are lower or
greater than Twenty-Six Million U.S. Dollars ($26,000,000), then the ALN-AGT
Phase 2 Success Payments will be adjusted to reflect the applicable MoIC
multiplied by the actual ALN-AGT Phase 2 Development Costs paid by Blackstone
hereunder. By way of example, if the actual ALN-AGT Phase 2
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Development Costs equal Twenty Million U.S. Dollars ($20,000,000), then the
ALN-AGT Phase 2 Success Payments would be equal to $20,000,000 x 3.25 =
$65,000,000.
6.2.2.2 Adjustment for Phase 2 Success Delay. Following completion of the
ALN-AGT Phase 1 Clinical Trial but prior to Blackstone commencing to pay the
ALN-AGT Phase 2 Development Costs, the estimated date for the receipt of the
results of the rand DB PCT IA (as such event is defined in the ALN-AGT
Development Plan) for such ALN-AGT Phase 2 Trial (such estimated completion
date, the “ALN-AGT Phase 2 Success Target”) will be finalized by the Parties and
the Timeline will be amended to include such date. In the event that the ALN-AGT
Phase 2 Success Payment Trigger has not been achieved by the ALN-AGT Phase 2
Success Target, then, unless such delay is caused by a Force Majeure Event,
following the ALN-AGT Phase 2 Success Payment Trigger, the ALN-AGT Phase 2
Success Payments will be adjusted as follows [***].
6.2.3    ALN-AGT Phase 3 Success Payments.
6.2.3.1 Adjustment for Change in Development Costs. In the event that the actual
ALN-AGT Phase 3 Development Costs paid by Blackstone hereunder are lower or
greater than Fifty-Four Million U.S. Dollars ($54,000,000), then the ALN-AGT
Phase 3 Success Payments will be adjusted to reflect the applicable MoIC
multiplied by the actual ALN-AGT Phase 3 Development Costs paid by Blackstone
hereunder. By way of example, if the actual ALN-AGT Phase 3 Development Costs
equal Fifty Million U.S. Dollars ($50,000,000), then the ALN-AGT Phase 3 Success
Payments would be equal to $50,000,000 x 4.5 = $225,000,000.
6.2.3.2 Adjustment for Approval Delay. Following completion of the ALN-AGT Phase
2 Clinical Trial, but prior to Blackstone commencing to pay the ALN-AGT Phase 3
Development Costs, the estimated date for the first Regulatory Approval of
ALN-AGT (the “ALN-AGT Phase 3 Approval Target”) will be finalized by the Parties
and the Timeline will be amended to include such date. In the event that the
ALN-AGT Phase 3 Success Payment Trigger has not been achieved by the ALN-AGT
Phase 3 Approval Target, then, unless such delay is caused by a Force Majeure
Event, following the ALN-AGT Phase 3 Success Payment Trigger, the ALN-AGT Phase
3 Success Payments will be adjusted as follows [***].

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6.3    Method and Timing of Payment.
6.3.1    Success Payments. Commencing upon the date of the applicable Success
Payment Trigger, Blackstone (or its designee) will deliver invoices to Alnylam
for each applicable Success Payment within [***]. Alnylam will pay the amount
set forth on each such invoice within [***] following delivery of such invoice,
by wire transfer to Blackstone’s account that Blackstone will designate on such
invoice. Alnylam will provide Blackstone with written notice of each wire
transfer to Blackstone’s account. All amounts payable and calculations under
this Agreement will be in U.S. dollars.
6.3.2    Royalty Reports; Payments. During the Royalty Term for Vutrisiran,
within [***] after the end of each Calendar Quarter, Alnylam will deliver a
report to Blackstone (or its designee) specifying on a currency-by-currency
basis (a) gross sales in the relevant Calendar Quarter, (b) Net Sales in the
relevant Calendar Quarter (including a description (and amount) of any
deductions applied in determining the gross sales to Net Sales calculation), (c)
to the extent that such Net Sales includes sales not denoted in U.S. Dollars,
Alnylam’s exchange rate methodology shall be in accordance with GAAP, and (d)
the Royalty payable on such Net Sales. All Royalty payments due under Section
6.1.1.2 for each Calendar Quarter will be due and payable on the date that such
royalty report is due. In the event that, during the Royalty Term for
Vutrisiran, [***].
6.4    Late Payments. If Alnylam fails to pay any amount due under this
Agreement on the due date therefore, then, without prejudice to any other
remedies that Blackstone or its designee may have, such amount will bear
interest from the due date until payment of such amount is made, both before and
after any judgment, at a rate equal to [***] per annum, computed on the basis of
a year of three-hundred and sixty-five (365) days for the actual number of days
payment is delinquent, or if such rate exceeds the maximum amount permitted by
Applicable Law, at such maximum rate.
6.5    Taxes.
6.5.1    Tax Treatment. For all U.S. federal and applicable state and local tax
purposes, the Parties shall treat (i) Blackstone’s payment of any Development
Costs (pursuant to Article 4) as received by Alnylam as income in a taxable
transaction, (ii) Alnylam’s payment of any Success Payments and Royalty payments
(pursuant to this Article 6) as received by Blackstone in a taxable transaction,
(iii) the transactions contemplated under this Agreement as separate and
independent from any transactions entered into by Alnylam and Blackstone or
their Affiliates other than those contemplated by this Agreement, and (iv)
Alnylam’s payment of any Success Payments and Royalty payments (as set forth in
Article 6) as income from sources within the United States as defined under the
Code and the Treasury Regulations thereunder. If there is an inquiry by any
Governmental Authority related to this Section 6.5, the Parties shall cooperate
with each other in responding to such inquiry in a commercially reasonable
manner consistent with this Section 6.5.
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6.5.2    Withholding.
6.5.2.1To the extent a Party making a payment under this Agreement (the “Paying
Party”) is required by Applicable Law to deduct or withhold taxes on any payment
to the Party receiving such payment (the “Recipient Party”), the Paying Party
will be entitled to make such deduction or withholding. Prior to deducting and
withholding any amounts, the Paying Party shall notify the Recipient Party of
such deduction or withholding and cooperate with the Recipient Party as provided
in Section 6.5.3. If, notwithstanding such cooperation, the deduction or
withholding is not eliminated, then the Paying Party shall pay the amounts of
such taxes to the proper Governmental Authority in a timely manner and promptly
transmit to the Recipient Party a copy of a tax certificate or other evidence of
such deduction or withholding sufficient to enable the Recipient Party to claim
such payment of taxes or for a refund claim to the extent available under the
Applicable Law, as applicable. Notwithstanding anything to the contrary in this
Agreement, the Parties agree that no deduction or withholding shall be made by
Paying Party to the extent the Recipient Party has timely delivered to the
Paying Party a duly completed IRS From W-9, except to the extent such deduction
or withholding is required as a result of a change in Applicable Law after the
Effective Date.
6.5.2.2 If, as a result of a Withholding Action by the Paying Party (including
any assignee or successor), a deduction or withholding is required by Applicable
Law and the amount of such deduction or withholding exceeds the amount of
deduction or 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 Recipient Party such that, after withholding from the
payment contemplated by this Agreement and such additional amount, the Recipient
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 Recipient Party the amount of
deduction or withholding under the law of the applicable jurisdiction exceeds
the amount of such deduction or withholding that would been required in the
absence of such Withholding Action by the Recipient 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 Recipient
Party pursuant to the preceding sentence if the Recipient Party had not
committed such Withholding Action. For purposes of this Section 6.5.2.2,
“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 Party’s jurisdiction; (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 Party’s jurisdiction (or the direct exercise of such
rights by an Affiliate of such Party outside of the Party’s jurisdiction); (iii)
a redomiciliation
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of such Party, an assignee or a successor to a jurisdiction outside the
applicable jurisdiction of the Party, an assignee or a successor; and (iv) any
action taken after the Effective Date by such Party that causes this Agreement
or any payment contemplated by this Agreement to become subject to tax
(including by virtue of withholding or deduction) in one or more additional
jurisdictions after the Effective Date.
6.5.3    Tax Cooperation. The Parties will cooperate and produce on a timely
basis any tax forms or reports reasonably requested by the other Party in
connection with any payment made under this Agreement, including any tax forms
that may be reasonably necessary in order for such Party not to withhold tax or
to withhold tax at a reduced rate under an applicable bilateral income tax
treaty, including any IRS Forms W-9 or W-8BEN-E, as applicable. Each Party will
provide, upon request, to the other Party such tax forms at least thirty (30)
days prior to the due date for any such payments; provided that the request for
such forms was made in a timely manner. Each Party will provide the other with
commercially reasonable assistance to enable the recovery, as permitted by law,
of withholding taxes, VAT, or similar obligations resulting from payments made
under this Agreement, such recovery to be for the benefit of the Party bearing
such withholding tax or VAT. Each Party will provide commercially reasonable
cooperation to the other Party, at the other Party’s expense, in connection with
any official or unofficial tax audit or contest relating to tax payments made
with respect to amounts paid or payable to such other Party under this
Agreement.
6.5.4    Reporting. The parties hereto agree not to take any position that is
inconsistent with the provisions of this Section 6.5 and Section 14.13 on any
tax return or in any audit or other judicial or administrative proceeding unless
otherwise required pursuant to a “determination” under Section 1313 of the Code
or in connection with a settlement.
6.6    Accelerated Payment Option.
6.6.1    Success Payment Acceleration.
6.6.1.1 Alnylam will have the right, in its sole discretion (subject to the
Parties reaching agreement as set forth in Section 6.6.1.2), at any time
following the achievement of a Success Payment Trigger, to accelerate the
payment schedule for the applicable Success Payments.
6.6.1.2 In the event that Alnylam elects to accelerate the Success Payments for
Vutrisiran or ALN-AGT in accordance with Section 6.6.1, then Alnylam will
provide written notice to Blackstone of such election, and the Parties will
mutually agree upon a new accelerated payment schedule for the applicable
Success Payments. In the event that the Parties are unable to agree on a new
accelerated payment schedule for the applicable Success Payments within [***] of
Blackstone’s receipt of Alnylam’s notice in the foregoing sentence, then the
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matter will be escalated to the Executive Officers for attempted resolution by
good faith negotiations during a period of [***]. If, notwithstanding such good
faith negotiations, the Executive Officers fail to resolve such matter prior to
expiration of such [***] negotiation period, then the payment schedule set forth
in Section 6.1 will remain in place unless and until the Parties reach mutual
agreement.
6.6.2    Royalty Buy-Out. Alnylam will have the right, at any time following the
achievement of the Vutrisiran Success Payment Trigger until the conclusion of
the Royalty Term, to notify Blackstone that Alnylam wishes to repurchase from
Blackstone the right to receive the Royalty. Following Blackstone’s receipt of
such notice from Alnylam, Blackstone may elect, in its sole discretion, to
negotiate with Alnylam in good faith a purchase price for the Royalty. For the
avoidance of doubt, Blackstone will have no obligation to sell to Alnylam its
interest in the Royalty.
ARTICLE 7
SECURITY INTERESTS
7.1    Security Interest.
7.1.1    Grant. As security for the payment and performance in full when due of
the Alnylam Obligations, Alnylam hereby grants to the Administrative Agent for
the benefit of the Secured Parties, effective upon the Effective Date, a
security interest in (i) the ALN-AGT Collateral, (ii) Vutrisiran Collateral, and
(iii) the Development Costs Account; provided, however, that Blackstone’s
Security Interests with respect to Shared IP is subject to the license granted
to the Lenders (as such term is defined in the Term Loan Agreement) in and to
such Shared IP under the Term Loan Agreement.
7.1.2    Priority of Security Interest. Alnylam represents, warrants and
covenants that, subject to Administrative Agent’s making and maintaining any
filings necessary to achieve such perfection and the Intercreditor Agreement,
(i) the security interests in the Vutrisiran Collateral and the ALN-AGT
Collateral are valid and perfected first priority security interests, free and
clear of all Liens except for Permitted Liens, and (ii) the security interest in
the Development Cost Account will be a valid and perfected, first priority
security interest, free and clear of all Liens except for Permitted Liens of the
type set forth in clause (d) of the definition thereof ((i) and (ii), the
“Blackstone Security Interests”). Alnylam represents and warrants that, as of
the Effective Date, Alnylam has not authenticated any agreement authorizing any
secured party thereunder to file a financing statement in any Blackstone
Collateral, except to perfect Permitted Liens.
7.1.3    Acceleration of Success Payments Following Payment Default. Following
the achievement of the first Success Payment Trigger, if Alnylam has failed to
pay to Blackstone two (2) successive Success Payments at any time on the
applicable payment due date, then unless Alnylam has cured such second (2nd)
payment breach within [***] of
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such due date, the Administrative Agent, in its sole discretion, may, without
prejudice to any other remedies that Blackstone or its designee may have,
accelerate all remaining Success Payments for which the Success Payment Triggers
have been met, which Success Payments shall be immediately due and payable. For
clarity, in the event that, following a second (2nd) missed payment, Alnylam
cures such payment breach in accordance with the foregoing, then any failure by
Alnylam to pay a Success Payment on the applicable payment due date thereafter
shall, without an opportunity for Alnylam to cure such payment breach, trigger
the Administrative Agent’s acceleration right set forth in this Section 7.1.3.
7.1.4    Blackstone Collateral Exclusions. The security interest granted herein
the Blackstone Collateral will remain in effect until the earlier of (a)
Alnylam, pursuant to Section 6.1.1.3 or 6.1.3.2 (as applicable), shall cease to
have any obligation to pay any Success Payments, and (b) all Alnylam Obligations
(other than contingent indemnity obligations) have been paid or otherwise
satisfied in full in accordance with this Agreement. Upon payment or other
satisfaction of all Alnylam Obligations (other than contingent indemnity
obligations), the Administrative Agent will, at the sole cost and expense of
Alnylam, release its Liens in the Blackstone Collateral and all rights therein
will revert to Alnylam.
7.2    Authorization to File Financing Statements. Alnylam hereby authorizes the
Administrative Agent to file, on or at any time from time to time after the
Effective Date, and, promptly upon the reasonable request of the Administrative
Agent, Alnylam will execute and deliver to the Administrative Agent (as
applicable), financing statements, amendments to financing statements,
continuation financing statements, termination statements, security agreements
relating to the Blackstone Collateral constituting intellectual property,
notices and other documents and instruments, in form reasonably satisfactory to
the Administrative Agent, that are necessary or desirable to perfect and
continue perfection, maintain the priority of or provide notice of the Secured
Parties’ security interest in the Blackstone Collateral and to accomplish the
purpose of this Agreement, without notice to Alnylam, in all jurisdictions
determined by the Administrative Agent to be necessary or appropriate.
7.3    Negative Covenants.
7.3.1    Encumbrances. Except as permitted under Section 3.7, Alnylam will not,
without the Administrative Agent’s prior written consent:
7.3.1.1 create, incur, assume, allow, or suffer to exist any Lien on any of the
Blackstone Collateral, whether now owned or hereafter acquired, or assign or
convey any right to receive income with respect to the Blackstone Collateral
(other than royalty and other license fee obligations to licensors thereof in
accordance with the applicable license agreement), including the sale of any
Blackstone Collateral, or permit any of its subsidiaries to do so, other than
Liens in favor of Blackstone and other Permitted Liens; or
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7.3.1.2 enter into any agreement, document, instrument or other arrangement
(except with or in favor of the Administrative Agent) with any Person which
expressly prohibits Alnylam or any subsidiary of Alnylam from assigning,
mortgaging, pledging, granting a security interest in the Blackstone Collateral
to the Administrative Agent.
7.4    Affirmative Covenants. Alnylam will do all of the following:
7.4.1    Execution of Additional Security Agreements and Other Further
Assurances. Alnylam will, upon the reasonable request of the Administrative
Agent from time to time hereafter, execute such security agreements, deposit
account control agreements, securities account control agreements and other
agreements and documents and take such further action, as reasonably required or
desired to perfect or continue the perfection of the Blackstone Security
Interests or to effect the purposes of this Article 7, including without
limitation by taking the following actions:
(a)    On or before the Effective Date, Alnylam will execute and deliver to the
Administrative Agent such patent and trademark security agreements as the
Administrative Agent may reasonably request, on the form set forth hereto as
Exhibit E (each an “IP Security Agreement”), and will record such agreements
with the U.S. Patent and Trademark Office. Within [***] of the last day of the
fiscal quarter during which the Effective Date occurred and each fiscal quarter
ending thereafter, Alnylam will notify the Administrative Agent in writing of
the creation or acquisition of any Intellectual Property owned by Alnylam that
is registered or becomes registered or the subject of an application for
registration with the U.S. Patent and Trademark Office, in each case during such
fiscal quarter then ended, and to the extent constituting Blackstone Collateral,
and will record a further IP Security Agreement (or amendment to an existing IP
Security Agreement) in each case in form and substance reasonably acceptable to
the Administrative Agent with the U.S. Patent and Trademark Office, and will
take such other action as may be necessary or as the Administrative Agent may
reasonably request to perfect the Administrative Agent’s security interest in
such Intellectual Property, subject to the limitations set forth in clause (d)
below. As between Alnylam and its Affiliates, Alnylam owns and will continue to
own all Vutrisiran Product IP and ALN-AGT Product IP (other than Regulatory
Approvals outside the United States, which may be owned by one or more of
Alnylam’s Affiliates). Notwithstanding the foregoing, an Affiliate of Alnylam
shall be permitted to own Vutrisiran Product IP or ALN-AGT Product IP provided
that (i) such Vutrisiran Product IP or ALN-AGT Product IP shall continue to be
part of the Vutrisiran Collateral or ALN-AGT Collateral, as the case may be; and
(ii) as a condition precedent to such ownership, such Affiliate agrees in
writing with Alnylam and the Secured Parties, in form reasonably satisfactory to
the Administrative Agent, to be bound by the obligations of Alnylam contained in
Sections 7.1.1, 7.1.2, 7.1.4, 7.2, 7.3 and 7.4 and thereby to grant to the
Administrative Agent, for the benefit of the Secured Parties, perfected security
interests in the Vutrisiran Product IP or ALN-AGT Product IP owned by such
Affiliate (including, with respect to any such Affiliate that is
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formed outside the United States, under the law of such Affiliate’s jurisdiction
of organization, if requested by the Administrative Agent).
(b)    On or before the Effective Date, Alnylam will execute and deliver to the
Administrative Agent an acknowledgment and consent to the Intercreditor
Agreement.
(c)    On or before the date that is sixty (60) days following the Effective
Date, Alnylam will execute and deliver to the Administrative Agent a springing
deposit account control agreement in favor of the Secured Parties with respect
to the Development Costs Account in customary form reasonably acceptable to the
Administrative Agent (together with any tri-party deposit account control
agreement or tri-party securities account control agreement entered into with
respect to a successor or additional Development Costs Account, the “Deposit
Account Control Agreement”). In addition to and without limiting the foregoing,
Alnylam will provide the Administrative Agent with prior written notice before
establishing any additional deposit account at or with any bank or financial
institution for the purpose of serving as a Development Costs Account pursuant
to Section 4.5. For each such successor or additional Development Costs Account
that Alnylam at any time proposes to maintain, Alnylam, as a condition precedent
to establishing such successor or additional Development Costs Account, will
cause the applicable bank or financial institution at or with which such
successor or additional Development Costs Account is proposed to be maintained
to execute and deliver to the Administrative Agent a tri-party deposit account
control agreement or tri-party securities account control agreement in customary
form reasonably acceptable to the Administrative Agent to perfect the Secured
Parties’ first priority security interest in such account.
(d)    At the Administrative Agent’s request, Alnylam will promptly execute and
deliver (or cause any Affiliate owning Blackstone Collateral to execute and
deliver) any and all further instruments and documents and take all such other
action as the Administrative Agent may reasonably deem necessary or desirable to
maintain in favor of the Secured Parties, Liens on the Blackstone Collateral
that are duly perfected in accordance with the requirements of all Applicable
Laws (to the extent required under this Agreement. Notwithstanding anything to
the contrary in this Agreement or any other document, in no event shall Alnylam
or its subsidiaries be required to, nor shall the Administrative Agent be
authorized to, take any of the following actions (i) execute, deliver or
otherwise obtain any agreement, instrument or documents governed by foreign law,
(ii) perfect any pledge, security interest by any means other than by (A)
filings pursuant to the UCC in the office of the secretary of state (or similar
filing office) of the relevant states and jurisdictions, (B) filings with the
USPTO, as applicable, with respect to Intellectual Property, and (C) entering
into account control agreements pursuant to Section 7.4.1(c) above, or (iii) to
take any actions with respect to any assets not located in the United States
(including any Intellectual Property registered or applied for in any
jurisdiction outside the United States) or enter into any security document
governed by the laws of a jurisdiction other than a jurisdiction within the
United States.
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7.4.2    Licenses Related to ALN-AGT and Vutrisiran.
7.4.2.1 For the purpose of enabling the Administrative Agent to exercise rights
and remedies under this Section Article 7 (including in order to take possession
of, collect, receive, assemble, process, appropriate, remove, realize upon,
sell, assign, license out, convey, transfer or grant options to purchase any
ALN-AGT Collateral or Vutrisiran Collateral), subject to the rest of this
Section 7.4.2, Alnylam hereby grants to the Administrative Agent, for the
benefit of the Secured Parties, an irrevocable (until the last day of the Term
and subject to the license carveouts in clauses (A) and (B) below),
nonexclusive, assignable license (which license may be exercised only upon an
breach or default by Alnylam hereunder (an “Event of Default”), without payment
of royalty or other compensation to Alnylam or any Subsidiary thereof),
including the right to practice, use, sublicense or otherwise exploit, solely in
connection with Vutrisiran or ALN-AGT or other items in the Blackstone
Collateral, any Intellectual Property now owned or hereafter acquired by Alnylam
or licensed or sublicensed to Alnylam, in each case that is relevant to any of
Vutrisiran and ALN-AGT, but excluding any Shared IP and any Vutrisiran Product
IP licensed to Alnylam and ALN-AGT Product IP licensed to Alnylam, and wherever
the same may be located, and including in such license reasonable access to all
media in which any of the licensed items may be recorded or stored and to all
computer software and programs used for the compilation or printout thereof to
the extent that such non-exclusive license (A) does not violate the express
terms of any agreement between Alnylam and a third party with respect to such
Intellectual Property existing as of the Effective Date (and such non-exclusive
license and access are and will be subject to and subordinate to the terms of
any Permitted License (as defined in the Term Loan Agreement as in effect on the
date hereof), excluding any Lien incurred under any Permitted Royalty Financing
(as defined in the Term Loan Agreement as in effect on the date hereof) entered
into by Alnylam after the Effective Date but prior to such Event of Default), or
gives such third party any right of acceleration, modification, termination or
cancellation therein and (B) is not prohibited by any Applicable Law; provided
that such license and sublicenses with respect to Trademarks shall be subject to
the maintenance of quality standards with respect to the goods and services on
which such Trademarks are used sufficient to preserve the validity of such
Trademarks. For clarity, the Administrative Agent may exercise such license
solely upon and during the continuation of an Event of Default and solely for
the purpose of exercising the remedies in accordance with this Agreement;
provided that any license, sublicense or other transaction entered into by the
Administrative Agent in accordance with the provisions of this Agreement shall
be binding upon Alnylam, notwithstanding any subsequent cure of an Event of
Default.
7.4.2.2 For the purpose of enabling the Administrative Agent to exercise rights
and remedies under this Section Article 7 (including in order to
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take possession of, collect, receive, assemble, process, appropriate, remove,
realize upon, sell, assign, license out, convey, transfer or grant options to
purchase any ALN-AGT Collateral or Vutrisiran Collateral), subject to the rest
of this Section 7.4.2, Alnylam hereby grants to the Administrative Agent, for
the benefit of the Secured Parties, an irrevocable (until the last day of the
Term and subject to the license carveouts in clauses (A) and (B) below),
nonexclusive, assignable license, including the right to practice, use,
sublicense or otherwise exploit, (which license may be exercised only upon an
Event of Default, without payment of royalty or other compensation to Alnylam or
any Subsidiary thereof) under any of the Shared IP owned by Alnylam now or
during the term of this Agreement prior to such Event of Default, to research,
develop, make, have made, import, export, sell, offer for sale, and otherwise
commercialize Vutrisiran and/or ALN-AGT, and including in such license
reasonable access to all media in which any of the licensed items may be
recorded or stored and to all computer software and programs used for the
compilation or printout thereof, in each case to the extent to the extent that
such non-exclusive license and/or access (A) does not violate the express terms
of any agreement between Alnylam and a third party with respect to such
Intellectual Property existing as of the Effective Date (and such non-exclusive
license and access are and will be subject to and subordinate to the terms of
any Permitted License (as defined in the Term Loan Agreement), excluding any
Lien incurred under any Permitted Royalty Financing (as defined in the Term Loan
Agreement) entered into by Alnylam after the Effective Date but prior to such
Event of Default), or gives such third party any right of acceleration,
modification, termination or cancellation therein and (B) is not prohibited by
any Applicable Law; provided that such license and sublicenses with respect to
Trademarks shall be subject to the maintenance of quality standards with respect
to the goods and services on which such Trademarks are used sufficient to
preserve the validity of such Trademarks. For clarity, the Administrative Agent
may exercise such license solely upon and during the continuation of an Event of
Default and solely for the purpose of exercising the remedies in accordance with
this Agreement; provided that any license, sublicense or other transaction
entered into by the Administrative Agent in accordance with the provisions of
this Agreement shall be binding upon Alnylam, notwithstanding any subsequent
cure of an Event of Default.
7.4.2.3 For the purpose of enabling the Administrative Agent to exercise rights
and remedies under this Section Article 7 (including in order to take possession
of, collect, receive, assemble, process, appropriate, remove, realize upon,
sell, assign, license out, convey, transfer or grant options to purchase any
ALN-AGT Collateral or Vutrisiran Collateral), subject to the rest of this
Section 7.4.2, Alnylam hereby agrees to grant to the Administrative Agent, for
the benefit of the Secured Parties, solely upon an Event of Default but without
payment of royalty or other compensation to Alnylam, an irrevocable (until the
last day of the Term and subject to the license carveouts in clauses (A) and (B)
below), nonexclusive,
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assignable license, including the right to practice, use, sublicense or
otherwise exploit, under any Vutrisiran Product IP or ALN-AGT Product IP
licensed or sublicensed to Alnylam now or during the term of this Agreement
prior to such Event of Default, to research, develop, make, have made, import,
export, sell, offer for sale, and otherwise commercialize Vutrisiran and/or
ALN-AGT, and including in such license reasonable access to all media in which
any of the licensed items may be recorded or stored and to all computer software
and programs used for the compilation or printout thereof to the extent that
such non-exclusive license and/or access (A) does not violate the express terms
of any agreement between Alnylam and a third party with respect to such
Intellectual Property existing as of the Effective Date (and such non-exclusive
license and access are and will be subject to and subordinate to the terms of
any Permitted License (as defined in the Term Loan Agreement), excluding any
Lien incurred under any Permitted Royalty Financing (as defined in the Term Loan
Agreement) entered into by Alnylam after the Effective Date but prior to such
Event of Default), or gives such third party any right of acceleration,
modification, termination or cancellation therein and (B) is not prohibited by
any Applicable Law; provided that such license and sublicenses with respect to
Trademarks shall be subject to the maintenance of quality standards with respect
to the goods and services on which such Trademarks are used sufficient to
preserve the validity of such Trademarks. For clarity, the foregoing license
shall not be granted unless and until the occurrence of an Event of Default, and
the foregoing license may be exercised solely for the purpose of exercising
remedies in accordance with this Agreement; provided that any license,
sublicense or other transaction entered into by Blackstone in accordance with
the provisions of this Agreement shall be binding upon Alnylam, notwithstanding
any subsequent cure of an Event of Default.
7.5    Administrative Agent.
7.5.1    Appointment and Authority.
7.5.1.1 Appointment. Each of the Blackstone Entities hereby irrevocably
appoints, designates and authorizes BXLS V BODYGUARD - PCP L.P. to act on its
behalf as the Administrative Agent hereunder and under the other Transaction
Agreements and authorizes the Administrative Agent to take such actions on its
behalf and to exercise such powers as are delegated to the Administrative Agent
by the terms hereof or thereof, together with such actions and powers as are
reasonably incidental thereto. The provisions of this Section 7.5 are solely for
the benefit of the Administrative Agent and the Blackstone Entities, and neither
Alnylam nor any of its Affiliates shall have rights as a third party beneficiary
of any of such provisions. It is understood and agreed that the use of the term
“agent” herein or in any other Transaction Agreements (or any other similar
term) with reference to the Administrative Agent is not intended to connote any
fiduciary or other implied (or express) obligations arising under agency
doctrine of any
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Applicable Law. Instead such term is used as a matter of market custom, and is
intended to create or reflect only an administrative relationship between
contracting parties.
7.5.1.2 Collateral Agent. The Administrative Agent shall also act as the
“collateral agent” under the Transaction Agreements, and each of the Blackstone
Entities hereby irrevocably appoints and authorizes the Administrative Agent to
act as the agent of such Blackstone Entity for purposes of acquiring, holding
and enforcing any and all Liens on Blackstone Collateral granted by Alnylam to
secure any of Alnylam’s obligations hereunder, together with such powers and
discretion as are reasonably incidental thereto. In this connection, the
Administrative Agent, as “collateral agent” and any co-agents, sub-agents and
attorneys-in-fact appointed by the Administrative Agent pursuant to Section
7.5.5 for purposes of holding or enforcing any Lien on the Blackstone Collateral
(or any portion thereof) granted under the Transaction Agreements, or for
exercising any rights and remedies thereunder at the direction of the
Administrative Agent, shall be entitled to the benefits of all provisions of
this Section 7.5 and Article 14 (as though such co-agents, sub-agents and
attorneys-in-fact were the “collateral agent” under the Transaction Agreements)
as if set forth in full herein with respect thereto. Without limiting the
generality of the foregoing, the Blackstone Entities hereby expressly authorize
the Administrative Agent to (i) execute any and all documents (including
releases) with respect to the Blackstone Collateral (including any intercreditor
agreement and any amendment, supplement, modification or joinder with respect
thereto) and the rights of any secured party with respect thereto, as
contemplated by and in accordance with the provisions of this Agreement and the
other Transaction Agreements and acknowledge and agree that any such action by
the Administrative Agent shall bind the Blackstone Entities and (ii) negotiate,
enforce or settle any claim, action or proceeding affecting the Blackstone
Entities in their capacity as such, at the direction of the Required Investors,
which negotiation, enforcement or settlement will be binding upon each
Blackstone Entity.
7.5.1.3 Fees. No fees shall be payable to the Administrative Agent by Alnylam or
the Blackstone Entities in respect of the Administrative Agent’s service as
collateral agent or administrative agent hereunder, except as may otherwise be
agreed in writing by the Administrative Agent and such Person(s).
7.5.1.4 Costs and Expenses. The Blackstone Entities shall pay all reasonable and
documented out-of-pocket expenses incurred by the Administrative Agent (limited,
in the case of legal counsel, to the reasonable and documented fees, charges and
disbursements of one legal counsel to the Administrative Agent), in connection
with the preparation, negotiation, execution, delivery and administration of
this Agreement and the other Transaction Agreements or any amendments,
modifications or waivers of the provisions hereof or thereof (whether or not the
transactions contemplated hereby or thereby shall be
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consummated), in each relevant jurisdiction (which may include a single special
counsel acting in multiple jurisdictions, in each case, in relevant
jurisdictions material to the interests of the Blackstone Entities), in
connection with the enforcement or protection of its rights (A) in connection
with this Agreement and the other Transaction Agreements, including its rights
under this Section 7.5.1.4, or (B) in connection with the transactions
contemplated hereby, including all such out-of-pocket expenses incurred during
any workout, restructuring or negotiations in respect of such transactions.
7.5.1.5 Indemnification by the Blackstone Entities. The Blackstone Entities
shall indemnify the Administrative Agent (and any sub-agent thereof) and each
Affiliate of any of the foregoing Persons (each such Person being called an
“Agent Indemnitee”) against, and hold each Agent Indemnitee harmless from, any
and all losses, claims, damages, liabilities and related expenses (including the
fees, charges and disbursements of any counsel for any Indemnitee) incurred by
any Agent Indemnitee or asserted against any Agent Indemnitee by any Person
(including Alnylam or any other Blackstone Entity) arising out of, in connection
with, or as a result of (i) the execution or delivery of this Agreement, any
other Transaction Agreement or any agreement or instrument contemplated hereby
or thereby, the performance by the parties hereto of their respective
obligations hereunder or thereunder or the consummation of the transactions
contemplated hereby or thereby, or, in the case of the Administrative Agent (and
any sub-agent thereof) and its Affiliates only, the administration of this
Agreement and the other Transaction Agreements, (ii) any payments or the use or
proposed use of the proceeds therefrom, or (iii) any actual or prospective
claim, litigation, investigation or proceeding relating to any of the foregoing,
whether based on contract, tort or any other theory, whether brought by a third
party or by Alnylam or any other Blackstone Entity, and regardless of whether
any Agent Indemnitee is a party thereto; provided that such indemnity shall not,
as to any Agent Indemnitee, be available to the extent that such losses, claims,
damages, liabilities or related expenses (x) are determined by a court of
competent jurisdiction by final and non-appealable judgment to have resulted
from the gross negligence or willful misconduct of such Agent Indemnitee, (y)
other than an Agent Indemnitee that is not the Administrative Agent and its
Affiliates, result from a claim brought by any other Blackstone Entity against
an Agent Indemnitee for a material breach of such Agent Indemnitee’s obligations
hereunder or under any other Transaction Agreement, if such Blackstone Entity
has obtained a final and non-appealable judgment in its favor on such claim as
determined by a court of competent jurisdiction or (z) result from a claim not
involving an act or omission of a Blackstone Entity and that is brought by an
Agent Indemnitee against another Agent Indemnitee (other than against the
Administrative Agent, any sub-agents and their Affiliates, in their capacities
as such). This Section 7.5.1.5 shall not apply with respect to taxes other than
any taxes that represent losses, claims, damages, etc. arising from any non-tax
claim.
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7.5.1.6 Waiver of Consequential Damages, Etc. To the fullest extent permitted by
Applicable Law, no Blackstone Entity shall assert, and each Blackstone Entity
hereby waives, and acknowledges that no other Person shall have, any claim
against any Agent Indemnitee, on any theory of liability, for special, indirect,
consequential or punitive damages (as opposed to direct or actual damages)
arising out of, in connection with, or as a result of, this Agreement, any other
Transaction Agreement or any agreement or instrument contemplated hereby, the
transactions contemplated hereby or thereby, any payments contemplated hereby or
the use or proposed use of the proceeds thereof. No Agent Indemnitee referred to
in Section 7.5.1.5 above shall be liable for any damages arising from the use by
unintended recipients of any information or other materials distributed to such
unintended recipients by such Agent Indemnitee through telecommunications,
electronic or other information transmission systems in connection with this
Agreement or the other Transaction Agreements or the transactions contemplated
hereby or thereby.
7.5.1.7 Payments. All amounts due under this Section 7.5.1 shall be payable not
later than [***] after demand therefor together with a reasonably detailed
invoice with respect thereto.
7.5.2    Right as a Blackstone Entity. If a Blackstone Entity is serving as the
Administrative Agent hereunder, such Person shall have the same rights and
powers in its capacity as a Blackstone Entity as any other Blackstone Entity and
may exercise the same as though it were not the Administrative Agent and the
term “Blackstone Entities” shall, unless otherwise expressly indicated or unless
the context otherwise requires, include the Person serving as the Administrative
Agent hereunder in its individual capacity. Such Person and its Affiliates may
generally engage in any kind of financing or other business with Alnylam or
other Affiliate thereof as if such Person were not the Administrative Agent
hereunder and without any duty to account therefor to the Blackstone Entities or
to provide notice to or consent of the Blackstone Entities with respect thereto.
Notwithstanding anything to the contrary, any waiver or release by Alnylam of
the Administrative Agent or Collateral Agent contained in this Section 7.5 shall
be solely with respect to the Person serving in its capacity as Administrative
Agent or Collateral Agent and shall not be deemed a release or waiver of any
Blackstone Entity or any other Person in any other capacity or for any other
purposes set forth in this Agreement.
7.5.3    Exculpatory Provisions.
7.5.3.1Neither the Administrative Agent nor any of its officers, partners,
directors, employees or agents shall have any duties or obligations except those
expressly set forth herein and in the other Transaction Agreements, and its
duties hereunder shall be administrative in nature. Without limiting the
generality of the foregoing, the Administrative Agent and each of its officers,
partners, directors, employees or agents:
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(i)    shall not be subject to any fiduciary or other implied duties, regardless
of whether an Event of Default has occurred and is continuing and without
limiting the generality of the foregoing, the use of the term “agent” herein and
in other Transaction Agreements with reference to the Administrative Agent is
not intended to connote any fiduciary or other implied (or express) obligations
arising under any agency doctrine of any Applicable Law and instead, such term
is used merely as a matter of market custom, and is intended to create or
reflect only an administrative relationship between independent contracting
parties;
(ii)    shall not have any duty to take any discretionary action or exercise any
discretionary powers, except discretionary rights and powers expressly
contemplated hereby or by the other Transaction Agreements that the
Administrative Agent is required to exercise as directed in writing by the
Required Investors (or such other number or percentage of the Blackstone
Entities as shall be expressly provided for herein or in the other Transaction
Agreements); provided that the Administrative Agent shall not be required to
take any action that, in its opinion or the opinion of its counsel, may expose
the Administrative Agent to liability or that is contrary to any Transaction
Agreement or Applicable Law, including for the avoidance of doubt refraining
from any action that, in its respective opinion or the opinion of its respective
counsel, may be a violation of the automatic stay under any bankruptcy,
reorganization, insolvency, or similar laws or that may effect a forfeiture,
modification or termination of property of a defaulting Blackstone Entity in
violation of any bankruptcy, reorganization, insolvency, or similar laws;
(iii)    shall not have any duty or responsibility to disclose, and shall not be
liable for the failure to disclose, to any Blackstone Entity any credit or other
information concerning the business, prospects, operations, property, financial
and other condition or creditworthiness of Alnylam or any of its Affiliates that
is communicated to, or in the possession of, the Administrative Agent or any of
the Blackstone Indemnified Parties in any capacity, except for notices, reports
and other documents expressly required to be furnished to the Blackstone
Entities by the Administrative Agent herein;
(iv)    shall not be liable for any action taken or not taken by it (A) with the
consent or at the request of the Required Investors (or such other number or
percentage of the Blackstone Entities as shall be necessary, or as the
Administrative Agent shall believe in good faith shall be necessary, under the
circumstances as provided in this Article 7) or (B) in the absence of its own
gross negligence or willful misconduct as determined by the final and
non-appealable judgment of a court of competent jurisdiction. The Administrative
Agent shall not be deemed to have knowledge of any Event of Default unless and
until written notice describing such Event of Default is given to the
Administrative Agent by Alnylam or a Blackstone Entity;
(v)    shall not be responsible for or have any duty to ascertain or inquire
into (A) any statement, warranty or representation made in or in connection with
this Agreement or any other Transaction Agreement, (B) the contents of any
certificate,
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report or other document delivered hereunder or thereunder or in connection
herewith or therewith, (C) the performance or observance of any of the
covenants, agreements or other terms or conditions set forth herein or therein
or the occurrence of any Event of Default, (D) the validity, enforceability,
effectiveness or genuineness of this Agreement, any other Transaction Agreement
or any other agreement, instrument or document, or the creation, perfection or
priority of any Lien purported to be created by the Transaction Agreements, (E)
the value or the sufficiency of any Blackstone Collateral, or (F) the
satisfaction of any condition set forth herein, other than to confirm receipt of
items expressly required to be delivered to the Administrative Agent;
(vi)    shall not be responsible for (A) perfecting, maintaining, monitoring,
preserving or protecting the security interest or Lien granted under this
Agreement, any other Transaction Agreement or any agreement or instrument
contemplated hereby or thereby, (B) the filing, re-filing, recording,
re-recording or continuing or any document, financing statement, mortgage,
assignment, notice, instrument of further assurance or other instrument in any
public office at any time or times or (C) providing, maintaining, monitoring or
preserving insurance on or the payment of taxes with respect to any of the
Blackstone Collateral. The actions described in items (A) through (C) shall be
the sole responsibility of Alnylam;
(vii)    shall not be responsible or liable for any failure or delay in the
performance of its obligations under this Agreement or the other Transaction
Agreements arising out of or caused, directly or indirectly, by circumstances
beyond its reasonable control, including, without limitation, acts of God;
earthquakes; fire; flood; terrorism; wars and other military disturbances;
sabotage; epidemics; pandemics, riots; business interruptions; loss or
malfunctions of utilities, computer (hardware or software) or communication
services; accidents; labor disputes; acts of civil or military authority and
governmental action;
(viii)    shall not be (A) required to qualify in any jurisdiction in which it
is not presently qualified to perform its obligations as such Administrative
Agent or (B) required to take any enforcement action against Alnylam or any
other obligor outside of the United States;
(ix)    shall not be responsible for the negligence, misconduct or other action
or inaction of any sub-agent that it selects as provided in Section 7.5.5 absent
gross negligence or willful misconduct by the Administrative Agent (as
determined in a final and non-appealable judgment by a court of competent
jurisdictions) in the selection of such sub-agents;
(x)    shall neither be responsible for, nor chargeable with, knowledge of the
terms and conditions of any other agreement, instrument, or document other than
this Agreement and any other Transaction Agreement to which Administrative
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Agent is a party, whether or not an original or a copy of such agreement has
been provided to the Administrative Agent; and
(xi)    shall not be responsible for nor have any duty to monitor the
performance or any action of Alnylam, the Blackstone Entities, or any of their
directors, members, officers, agents, Affiliates or employee, nor shall they
have any liability in connection with the malfeasance or nonfeasance by such
party; the Administrative Agent may assume performance by all such Persons of
their respective obligations.
7.5.3.2 Each Blackstone Entity acknowledges and agrees that neither such
Blackstone Entity, nor any of its Affiliates, participants or assignees, may
rely on the Administrative Agent to carry out such Blackstone Entity’s,
Affiliate’s, participant’s or assignee’s customer identification program, or
other obligations required or imposed under or pursuant to any anti-terrorism
Law, including any programs involving any of the following items relating to or
in connection with Alnylam or its Subsidiaries, any of their respective
Affiliates or agents, the Transaction Agreements or the transactions hereunder:
(i) any identity verification procedures, (ii) any record keeping, (iii) any
comparisons with government lists, (iv) any customer notices or (v) any other
procedures required under any anti-terrorism Law.
7.5.3.3 The delivery by Alnylam of any reports, information and documents to the
Administrative Agent is for informational purposes only and the Administrative
Agent’s receipt of such shall not constitute constructive notice of any
information contained therein or determinable from information contained
therein. Each party to this Agreement acknowledges and agrees that the
Administrative Agent may, but shall not be obligated to, from time to time use
one or more outside service providers for the tracking of all UCC financing
statements (and/or other collateral related filings and registrations from time
to time) required to be filed or recorded pursuant to the Transaction Agreements
and the notification to the Administrative Agent, of, among other things, the
upcoming lapse or expiration thereof, and that each of such service providers
will be deemed to be acting at the request and on behalf of Alnylam. The
Administrative Agent shall not be liable for any action taken or not taken by
any such service provider. Neither the Administrative Agent nor any of its
officers, partners, directors, employees or agents shall be liable to the
Blackstone Entities for any action taken or omitted by the Administrative Agent
under or in connection with any of the Transaction Agreements.
7.5.4    Reliance by Administrative Agent. The Administrative Agent shall be
entitled to rely upon, and shall be fully protected in relying and shall not
incur any liability for relying upon, any notice, request, certificate,
communication, consent, statement, instrument, document or other writing
(including any electronic message, Internet or intranet website posting or other
distribution) believed by it to be genuine and to have been signed,
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sent or otherwise authenticated by the proper Person. The Administrative Agent
also may rely upon any statement made to it orally or by telephone and believed
by it to have been made by the proper Person, and shall be fully protected in
relying and shall not incur any liability for relying thereon. In determining
compliance with any condition hereunder to the Blackstone Entities’ funding
obligations under this Agreement that by its terms must be fulfilled to the
satisfaction of a Blackstone Entity, the Administrative Agent may presume that
such condition is satisfactory to such Blackstone Entity unless the
Administrative Agent shall have received notice to the contrary from such
Blackstone Entity prior to funding such obligation. The Administrative Agent may
consult with legal counsel (who may be counsel for the Blackstone Entities),
independent accountants and other experts selected by it, and shall not be
liable for any action taken or not taken by it in accordance with the advice of
any such counsel, accountants or experts. For purposes of determining compliance
with the conditions specified in Section 4.2, each Blackstone Entity that has
signed this Agreement shall be deemed to have consented to, approved or accepted
or to be satisfied with, each document or other matter required thereunder to be
consented to or approved by or acceptable or satisfactory to a Blackstone Entity
unless the Administrative Agent shall have received written notice from such
Blackstone Entity prior to the proposed funding date specifying its objections.
7.5.5    Delegation of Duties. The Administrative Agent may perform any and all
of its duties and exercise its rights and powers hereunder or under any other
Transaction Agreement by or through any one or more sub-agents appointed by the
Administrative Agent. The Administrative Agent and any such sub-agent may
perform any and all of its duties and exercise its rights and powers by or
through their Affiliates. The exculpatory provisions of this Section 7.5 shall
apply to any such sub-agent, their respective Affiliates and to the Blackstone
Indemnified Parties, and shall apply to their activities as Administrative
Agent. The Administrative Agent shall not be responsible for the negligence or
misconduct of any sub-agents except to the extent that a court of competent
jurisdiction determines in a final and non-appealable judgment that the
Administrative Agent acted with gross negligence or willful misconduct in the
selection of such sub-agents.
7.5.6    Resignation.
7.5.6.1 Notice. The Administrative Agent may at any time give notice of its
resignation to the Blackstone Entities and Alnylam. Upon receipt of any such
notice of resignation, the Required Investors shall have the right to appoint a
successor with the prior written consent of Alnylam (such consent not to be
unreasonably withheld, conditioned or delayed). If no such successor shall have
been so appointed by the Required Investors and shall have accepted such
appointment within thirty (30) days after the retiring Administrative Agent
gives notice of its resignation (or such earlier day as shall be agreed by the
Required Investors) (the “Resignation Effective Date”), then the retiring
Administrative Agent may (but shall not be obligated to) on behalf of the
Blackstone Entities appoint a successor Administrative Agent with the prior
written consent of Alnylam (such
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consent not to be unreasonably withheld, conditioned or delayed). Whether or not
a successor has been appointed, such resignation shall become effective in
accordance with such notice on the Resignation Effective Date. In addition, upon
not less than ten (10) days prior written notice (the “Removal Effective Date”),
the Administrative Agent may be removed (with or without cause) by the Required
Investors at any time in their sole discretion, but with the prior written
consent of Alnylam (such consent not to be unreasonably withheld, conditioned or
delayed). Notwithstanding the foregoing and for the avoidance of doubt,
Alnylam’s consent shall not be required for any successor or replacement
Administrative Agent that is, or is an Affiliate of, (a) any Blackstone Entity,
or (b) any Person to whom a Blackstone Entity has assigned any of its
obligations and rights hereunder in accordance with Section 14.6. Solely for
purposes of the foregoing sentence, “Affiliate” shall include The Blackstone
Group Inc. and any of its divisions, including Blackstone Life Science Advisors
L.L.C.
7.5.6.2 Effect of Resignation or Removal. With effect from the Resignation
Effective Date or the Removal Effective Date, as applicable (i) the retiring or
removed Administrative Agent shall be discharged from its duties and obligations
hereunder and under the other Transaction Agreements and (ii) except for any
indemnity payments or other amounts then owed to the retiring Administrative
Agent, all payments, communications and determinations provided to be made by,
to or through the Administrative Agent shall instead be made by or to each
Blackstone Entity directly, until such time, if any, as the Required Investors
or retiring Administrative Agent appoint a successor Administrative Agent as
provided for above. Upon the acceptance of a successor’s appointment as
Administrative Agent hereunder, such successor shall succeed to and become
vested with all of the rights, powers, privileges and duties of the retiring
Administrative Agent and other than any rights to indemnity payments or other
amounts owed to the retiring or removed Administrative Agent as of the
Resignation Effective Date or the Removal Effective Date, as applicable), and
the retiring or removed Administrative Agent shall be discharged from all of its
duties and obligations hereunder or under the other Transaction Agreements (if
not already discharged therefrom as provided above in this Section 7.5.6). After
the retiring or removed Administrative Agent’s resignation or removal hereunder
and under the other Transaction Agreements, the provisions of this Section 7.5
shall continue in effect for the benefit of such retiring or removed
Administrative Agent, its sub agents and their respective Affiliates in respect
of any actions taken or omitted to be taken by any of them (A) while the
retiring Administrative Agent was acting as Administrative Agent and (B) after
such resignation for as long as any of them continues to act in any capacity
hereunder or under the other Transaction Agreements, including, without
limitation, (1) acting as collateral agent or otherwise holding any collateral
security on behalf of any of the Secured Parties and (2) in respect of any
actions taken in connection with transferring the agency to any successor
Administrative Agent.
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7.5.7    Non-Reliance on Administrative Agent and the Other Blackstone Entities
Each Blackstone Entity expressly acknowledges that the Administrative Agent has
not made any representation or warranty to it, and that no act by the
Administrative Agent hereafter taken, including any consent to, and acceptance
of any assignment or review of the affairs of Alnylam or any Affiliate thereof,
shall be deemed to constitute any representation or warranty by the
Administrative Agent to any Blackstone Entity as to any matter, including
whether the Administrative Agent has disclosed material information in its (or
its Affiliates’) possession. Each Blackstone Entity represents to the
Administrative Agent that it has, independently and without reliance upon the
Administrative Agent, any other Blackstone Entity or any of their respective
Affiliates and based on such documents and information as it has deemed
appropriate, made its own analysis of, appraisal of, and investigation into, the
business, prospects, operations, property, financial and other condition and
creditworthiness of Alnylam and its Subsidiaries, and all Applicable Laws
relating to the transactions contemplated hereby, and made its own decision to
enter into this Agreement. Each Blackstone Entity also acknowledges that it
will, independently and without reliance upon the Administrative Agent, any
other Blackstone Entity or any of their respective Affiliates and based on such
documents and information as it shall from time to time deem appropriate,
continue to make its own analysis, appraisals and decisions in taking or not
taking action under or based upon this Agreement, any other Transaction
Agreement or any related agreement or any document furnished hereunder or
thereunder, and to make such investigations as it deems necessary to inform
itself as to the business, prospects, operations, property, financial and other
condition and creditworthiness of Alnylam. Each Lender represents and warrants
that it is sophisticated with respect to decisions to make, acquire and/or hold
financial investments as set forth herein, and either it, or the Person
exercising discretion in making its decision to make, acquire and/or hold such
financial investments, is experienced in making, acquiring or holding such
financial investments.
7.5.8    No Other Duties, Etc. The Administrative Agent may at any time request
instructions from the Blackstone Entities with respect to any actions or
approvals which by the terms of this Agreement or of any of the other
Transaction Agreements the Administrative Agent is permitted or desires to take
or to grant, and if such instructions are promptly requested, the Administrative
Agent shall be absolutely entitled to refrain from taking any action or to
withhold any approval and shall not be under any liability whatsoever to any
Person for refraining from any action or withholding any approval under any of
the Transaction Agreements until it shall have received such instructions from
the Required Investors or all or such other portion of the Blackstone Entities
as shall be prescribed by this Agreement. Without limiting the foregoing, no
Person shall have any right of action whatsoever against the Administrative
Agent as a result of the Administrative Agent acting or refraining from acting
under this Agreement or any of the other Transaction Agreements in accordance
with the instructions of the Required Investors (or all or such other portion of
the Blackstone Entities as shall be prescribed by this Agreement) and,
notwithstanding the instructions of the Required Investors (or such other
applicable portion of the Blackstone Entities), the Administrative Agent shall
have no obligation to take any action if it believes,
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in good faith, that such action would violate Applicable Law or exposes the
Administrative Agent to any liability for which it is not entitled to
satisfactory reimbursement and indemnification in accordance with the provisions
of Section 7.5.1.5. Anything herein to the contrary notwithstanding, none of the
titles listed on the cover page hereof shall have any powers, duties or
responsibilities under this Agreement or any of the other Transaction
Agreements, except in its capacity, as applicable, as the Administrative Agent
or a Blackstone Entity hereunder.
7.5.9    Administrative Agent May File Proofs of Claim; Credit Bidding.
7.5.9.1 In case of the pendency of any proceeding under any bankruptcy,
reorganization, insolvency, or similar laws or any other judicial proceeding
relative to Alnylam, the Administrative Agent (irrespective of whether the
Alnylam Obligations shall then be due and payable as herein expressed or by
declaration or otherwise and irrespective of whether the Administrative Agent
shall have made any demand on Alnylam) shall be entitled and empowered, by
intervention in such proceeding or otherwise:
(i)    to file and prove a claim for the whole amount of the Alnylam Obligations
owing and unpaid and all other obligations that are owing and unpaid and to file
such other documents as may be necessary or advisable in order to have the
claims of the Blackstone Entities and the Administrative Agent (including any
claim for the reasonable compensation, expenses, disbursements and advances of
the Blackstone Entities and the Administrative Agent and their respective agents
and counsel to the extent provided for herein and all other amounts due the
Blackstone Entities and the Administrative Agent under Section 7.5.1) allowed in
such judicial proceeding; and
(ii)    to collect and receive any monies or other property payable or
deliverable on any such claims and to distribute the same;
7.5.9.2 and any custodian, receiver, assignee, trustee, liquidator, sequestrator
or other similar official in any such judicial proceeding is hereby authorized
by each Blackstone Entity to make such payments to the Administrative Agent and,
in the event that the Administrative Agent shall consent to the making of such
payments directly to the Blackstone Entities, to pay to the Administrative Agent
any amount due for the reasonable compensation, expenses, disbursements and
advances of the Administrative Agent and its agents and counsel, and any other
amounts due the Administrative Agent under Section 7.5.1.
7.5.9.3 Nothing contained herein shall be deemed to authorize the Administrative
Agent to authorize or consent to or accept or adopt on behalf of any Blackstone
Entity any plan of reorganization, arrangement, adjustment or composition
affecting the Alnylam Obligations or the rights of any to authorize the
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Administrative Agent to vote in respect of the claim of any Blackstone Entity or
in any such proceeding.
7.5.9.4 The Blackstone Entities hereby irrevocably authorize the Administrative
Agent, at the direction of the Required Investors, to credit bid all or any
portion of the Alnylam Obligations (including accepting some or all of the
Blackstone Collateral in satisfaction of some or all of the Alnylam Obligations
pursuant to a deed in lieu of foreclosure or otherwise) and in such manner
purchase (either directly or through one or more acquisition vehicles) all or
any portion of the Blackstone Collateral (i) at any sale thereof conducted under
the provisions of the Bankruptcy Code of the United States, including under
Sections 363, 1123 or 1129 of the Bankruptcy Code of the United States, or any
similar Laws in any other jurisdictions to which Alnylam is subject, (ii) at any
other sale or foreclosure or acceptance of collateral in lieu of debt conducted
by (or with the consent or at the direction of) the Administrative Agent
(whether by judicial action or otherwise) in accordance with any Applicable Law.
In connection with any such credit bid and purchase, the Alnylam Obligations
owed to the Blackstone Entities shall be entitled to be, and shall be, credit
bid on a ratable basis (with Alnylam Obligations with respect to contingent or
unliquidated claims receiving contingent interests in the acquired assets on a
ratable basis that would vest upon the liquidation of such claims in an amount
proportional to the liquidated portion of the contingent claim amount used in
allocating the contingent interests) in the asset or assets so purchased (or in
the equity interests or debt instruments of the acquisition vehicle or vehicles
that are used to consummate such purchase). In connection with any such bid (A)
the Administrative Agent shall be authorized to form one or more acquisition
vehicles to make a bid, (B) to adopt documents providing for the governance of
the acquisition vehicle or vehicles (provided that any actions by the
Administrative Agent with respect to such acquisition vehicle or vehicles,
including any disposition of the assets or equity interests thereof shall be
governed, directly or indirectly, by the vote of the Required Investors,
irrespective of the termination of this Agreement), and (C) to the extent that
Alnylam Obligations that are assigned to an acquisition vehicle are not used to
acquire Blackstone Collateral for any reason (as a result of another bid being
higher or better, because the amount of Alnylam Obligations assigned to the
acquisition vehicle exceeds the amount of debt credit bid by the acquisition
vehicle or otherwise), such Alnylam Obligations shall automatically be
reassigned to the Blackstone Entities pro rata and the equity interests and/or
debt instruments issued by any acquisition vehicle on account of the Alnylam
Obligations that had been assigned to the acquisition vehicle shall
automatically be cancelled, without the need for any Blackstone Entity or any
acquisition vehicle to take any further action.
7.5.10    Collateral Matters.
7.5.10.1 Each of the Blackstone Entities irrevocably authorize the
Administrative Agent, at its option and in its discretion,
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(i)    to release any Lien on any property granted to or held by the
Administrative Agent under any Transaction Agreement (A) upon all Alnylam
Obligations (other than contingent indemnity obligations) having been paid or
otherwise satisfied in full in accordance with this Agreement, or (B) if
approved, authorized or ratified in writing by the Required Investors; and
(ii)    to subordinate any Lien on any property granted to or held by the
Administrative Agent under any Transaction Agreement to the holder of any Lien
on such property if approved, authorized or ratified in writing by the Required
Investors.
7.5.10.2 Upon request by the Administrative Agent at any time, the Required
Investors will confirm in writing the Administrative Agent’s authority to
release or subordinate its interest in particular types or items of property
pursuant to this Section 7.5.10. In each case as specified in this Section
7.5.10, the Administrative Agent will, at Alnylam’s expense, execute and deliver
to Alnylam such documents as Alnylam may reasonably request to evidence the
release of such item of Blackstone Collateral from the assignment and security
interest granted under the Transaction Agreements or to subordinate its interest
in such item, in each case in accordance with the terms of the Transaction
Agreements and this Section 7.5.10.
7.5.10.3 The Administrative Agent shall not be responsible for or have a duty to
ascertain or inquire into any representation or warranty regarding the
existence, value or collectability of the Blackstone Collateral, the existence,
priority or perfection of the Administrative Agent’s Lien thereon, or any
certificate prepared by Alnylam in connection therewith, nor shall the
Administrative Agent be responsible or liable to the Blackstone Entities for any
failure to monitor or maintain any portion of the Blackstone Collateral.
7.5.11    Survival. This Section 7.5 and any other indemnity provisions in favor
of any Agent Indemnitee elsewhere in this Agreement shall survive the
termination of this Agreement, the repayment, satisfaction or discharge of all
Obligations and the resignation, removal or replacement of the Administrative
Agent.
ARTICLE 8
RECORDS
8.1    Accounting. Alnylam will maintain complete and accurate accounting
records related to this Agreement in accordance with GAAP for [***] after the
conclusion of the Term.
8.2    Clinical Trials-Related Records. Alnylam will, and will cause its
Affiliates and its and their Permitted Third Parties conducting Development of
the Products to, maintain, in good scientific manner, complete and accurate
books and records pertaining to
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Development of the Products hereunder, in sufficient detail to verify compliance
with its obligations under this Agreement. Such books and records will (a) be
appropriate for patent and regulatory purposes, (b) be in compliance with
Applicable Law in all material respects, (c) properly reflect all work done and
results achieved in the performance of its Development activities hereunder, and
(d) be retained by such Party for such period as may be required by Applicable
Law.
8.3    Records; Audits. Alnylam will keep and maintain accurate and complete
records of Net Sales and Development Cost expenditures during the [***]
preceding Calendar Years. Upon [***] prior written notice from Blackstone,
Alnylam will permit an independent certified public accounting firm of
internationally recognized standing, selected by Blackstone and reasonably
acceptable to Alnylam, to examine the relevant books and records of Alnylam and
its Affiliates, as may be reasonably necessary to verify the royalty reports
provided by Alnylam in accordance with Section 6.3.2. An examination by
Blackstone under this Section 8.3 will occur not more than once in any Calendar
Year. The accounting firm will be provided access to such books and records at
Alnylam’s facility or facilities where such books and records are normally kept
and such examination will be conducted during Alnylam’s normal business hours.
Upon completion of the audit, the accounting firm will provide to both Parties a
written report disclosing whether the reports submitted by Alnylam are correct
or incorrect and the specific details concerning any discrepancies. No other
information will be provided to Blackstone. If the report or information
submitted by Alnylam results in an underpayment or overpayment, the Party owing
the underpaid or overpaid amount will promptly pay such amount to the other
Party. The costs and fees of any audit conducted by Blackstone under this
Section 8.3 will be borne by Blackstone, unless such audit reveals an
underpayment of amounts owed to Blackstone of more than [***] of the amount that
was owed by Alnylam with respect to the relevant period, in which case, Alnylam
will reimburse Blackstone for the reasonable expense incurred by Blackstone in
connection with the audit.
ARTICLE 9
CONFIDENTIAL INFORMATION
9.1    Confidentiality. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the Parties, each Party (each, a
“Receiving Party”) agrees that, during the Term and for the [***] period
following the conclusion of the Term (except that the obligations will survive
thereafter with respect to any Confidential Information that constitutes a trade
secret under Applicable Law) or such longer period for which such Confidential
Information may be maintained pursuant to Article 8, will keep confidential and
will not publish or otherwise disclose and will not use for any purpose other
than as provided for in this Agreement (which includes the exercise of any
rights or the performance of any obligations hereunder or thereunder) any
Confidential Information furnished to it by or on behalf of the other Party
(each, a “Disclosing Party”) or its Affiliates in connection with this
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Agreement. The foregoing obligations will not apply to any portion of such
information or materials that the Receiving Party can demonstrate:
9.1.1    was publicly disclosed by the Disclosing Party before or after such
Confidential Information becomes known to the Receiving Party;
9.1.2    was already known to the Receiving Party or any of its Affiliates,
other than under an obligation of confidentiality or non-use, prior to when it
was received from the Disclosing Party;
9.1.3    is subsequently disclosed to the Receiving Party or any of its
Affiliates by a Third Party lawfully in possession thereof without obligation to
keep such Confidential Information confidential;
9.1.4    has been published by a Third Party or otherwise enters the public
domain through no fault of the Receiving Party or any of its Affiliates in
breach of this Agreement; or
9.1.5    has been independently developed by the Receiving Party or any of its
Affiliates, without the aid, application or use of any Confidential Information
of the other Party.
9.2    Authorized Disclosure. Each Party may disclose Confidential Information
belonging to the other Party to the extent such disclosure is reasonably
necessary for complying with Applicable Laws, including regulations promulgated
by securities exchanges, provided that the Party required to disclose such
information promptly notifies the Disclosing Party prior to making any such
disclosure and cooperates with the Disclosing Party’s efforts to seek
confidential treatment or to otherwise limit disclosure. Each Receiving Party
may disclose the other Party’s Confidential Information to its Representatives,
in each case (a) only to the extent such Persons need to know the Confidential
Information solely in connection with the performance of this Agreement, and (b)
provided that each Person receiving Confidential Information must be bound by
obligations of confidentiality and non-use at least as stringent as an
equivalent in scope to those set forth in this Article 9 prior to any such
disclosure and the Party making such disclosure to such Person will be liable to
the other Party for any breach of such obligations by such disclosee (provided
that a Party’s Representative(s) will only be bound by the obligations set forth
in this Article 9 to the extent that such Representative(s) actually receives
such Confidential Information). Each Party may also disclose the material terms
of this Agreement and updates regarding the Development and Commercialization
progress of Products under this Agreement, or a summary of such Party’s findings
during its due diligence investigation of the Products (if applicable) to any
bona fide potential or actual investor, investment banker, acquirer, provider of
debt or royalty financing, or other potential or actual financial partner
without the consent of the other Party, and provided that in connection with
such disclosure, each disclosee must be bound by obligations of
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confidentiality and non-use at least as stringent as an equivalent in scope to
those set forth in this ARTICLE 10 prior to any such disclosure and the Party
making such disclosure to such disclosee will be liable to the other Party for
any breach of such obligations by such disclosee. Notwithstanding anything in
the foregoing to the contrary, the Development Plans, and all reports, results,
data or other information provided to Blackstone by or on behalf of Alnylam
constitute Alnylam’s Confidential Information, and Alnylam may disclose the
Development Plans to Third Parties as determined by Alnylam in its sole
discretion. For clarity, nothing in this Section 9.2 shall limit a Party from
disclosing or otherwise exploiting its own Confidential Information. In any
event, each Party agrees to take all reasonable action to avoid unauthorized use
or disclosure of Confidential Information of the other Party hereunder.
9.3    Return of Confidential Information. Except as otherwise provided herein,
upon expiration or earlier termination of this Agreement, all Confidential
Information (including any copies thereof) in written or other tangible form
will, at the Disclosing Party’s direction, be returned to the Disclosing Party
or destroyed by the Receiving Party, and any Person(s) to whom the Receiving
Party disclosed (with such destruction being confirmed in writing by an
authorized officer of the Receiving Party), except (i) to the extent such
Confidential Information is necessary to exercise any license or rights
hereunder that survive such expiration or earlier termination; and (ii) one (1)
copy of each document may be retained by the Receiving Party solely to the
extent necessary to permit it to comply with any ongoing rights and
responsibilities with respect to such Confidential Information.
9.4    Confidential Status of the Agreement. Subject to Section 9.2 and Section
9.5, the terms of this Agreement are deemed to be Confidential Information and
will be subject to the confidentiality requirements of this Article 9, with each
Party being deemed a Receiving Party for such purposes. The Parties each
acknowledge that it may be necessary for Alnylam to file this Agreement with the
U.S. Securities and Exchange Commission and to make other required public
disclosures regarding the terms of this Agreement, and accordingly Alnylam will
prepare a confidential treatment request in connection with such filing and
provide Blackstone a reasonable opportunity to review and comment on such filing
as well as on such other required public disclosures, which comments Alnylam
will consider and incorporate in good faith, and thereafter use Commercially
Reasonable Efforts to obtain confidential treatment as to the terms of this
Agreement.
9.5    Publicity. The Parties recognize that following the Effective Date the
Parties (either individually or jointly) will issue mutually agreed press
release(s) announcing the execution of this Agreement, and thereafter each Party
may from time to time desire to issue additional press releases and make other
public statements or disclosures regarding the subject matter of this Agreement,
and hereby agree that such additional press releases, public statements and
disclosures regarding the terms of this Agreement will be permitted only with
the other Party’s prior written consent (which will not be unreasonably
withheld, conditioned or delayed). Any publication, news release or other public
announcement relating to the terms of this Agreement will first be reviewed and
approved in writing by both Parties;
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provided, however, that any disclosure of the minimum information which is
required by Applicable Law (including the rules of a securities exchange), as
reasonably advised by the Disclosing Party’s counsel, may be made without the
prior consent of the other Party, although the other Party will be given prompt
notice of any such legally required disclosure and will be provided an
opportunity to comment on the proposed disclosure and the Disclosing Party will
consider in good faith any comments provided by the other Party on such proposed
disclosure.
ARTICLE 10
INTELLECTUAL PROPERTY
10.1    Ownership and Rights.
10.1.1    Ownership.
10.1.1.1 Alnylam will own and retain all right, title and interest in, to and
under all data, results, information, analyses, discoveries, inventions and
know-how that are Controlled by Alnylam as of the Effective Date and no such
right, title or interest therein, thereto or thereunder is granted to Blackstone
hereunder, except as expressly set forth herein.
10.1.1.2 Blackstone will own and retain all right, title and interest in, to and
under all data, results, information, analyses, discoveries, inventions and
know-how that are Controlled by Blackstone as of the Effective Date and no such
right, title or interest therein, thereto or thereunder is granted to Alnylam
hereunder, except as set forth herein.
10.1.1.3 As between the Parties, Alnylam and/or its Affiliates will be the
exclusive and sole owner of and retain all right, title and interest in, to and
under (a) the Products, (b) Research Results, (c) all discoveries, data,
results, summaries, know-how and inventions (whether or not patentable)
discovered, developed or invented by, or on behalf of, either Party, and any of
their Affiliates, and any Permitted Third Party, in performance of the Clinical
Trial (including the Research Results), and (d) all improvements that are
discovered, developed or invented by, or on behalf of Alnylam under or in
performance of this Agreement that relate to Intellectual Property that is
Controlled by Alnylam as of the Effective Date (collectively, the “Alnylam
Improvements”) and (d) all Intellectual Property in the foregoing subsections
(a) through (d) (all of the foregoing (a)-(d), collectively, the “Trial
Inventions”). Subject to Section Article 7, Blackstone will, and hereby does,
assign to Alnylam all rights, title and interest of Blackstone in, to and under
the Trial Inventions, if any.
10.1.1.4 The delivery or disclosure by or on behalf of Alnylam to Blackstone of
any information or materials hereunder will not be
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construed to grant Blackstone any rights or license to use any Intellectual
Property Controlled by Alnylam other than as necessary to comply with its
obligations hereunder or as expressly set forth herein. All Alnylam Intellectual
Property shall be deemed to be the Confidential Information of Alnylam.
10.2    Patent Prosecution. As between Blackstone and Alnylam, Alnylam will have
sole and exclusive right to prepare, file, prosecute and maintain all Patents
within the Alnylam Intellectual Property, including all Patents that cover the
Trial Inventions, at its own expense and in its sole discretion (but, for
clarity, using the level of efforts and resources that Alnylam uses with respect
to obtaining and maintaining intellectual property rights related to other
products with similar commercial potential), and will keep Blackstone reasonably
informed with respect thereto. Notwithstanding the foregoing, Alnylam will not
abandon or allow to lapse any Patents included in the ALN-AGT Product IP or the
Vutrisiran Product IP without providing Blackstone with prior written notice
thereof and considering any reasonable comments of Blackstone in good faith.
10.3    Intellectual Property Enforcement.
10.3.1    Alnylam Intellectual Property. Alnylam will have the sole and
exclusive right but not the obligation to enforce the Alnylam Intellectual
Property Controlled by Alnylam, including Intellectual Property that covers the
Trial Inventions, against Third Party Infringements at its sole expense and
discretion.
10.3.2    Infringement of Third Party Rights. If either Party learns of Third
Party allegations that Alnylam or any of its Affiliates or Permitted Third
Parties, have infringed, misappropriated or otherwise violated, or are
infringing, misappropriating or otherwise violating, any Intellectual Property
of a Third Party in connection with either the Product Clinical Trials or
performing its obligations or duties hereunder, such Party will promptly notify
the other Party. Alnylam will have sole control and responsibility of, and
discretion with respect to, such allegations and any related actions or
litigation at its sole expense, but will keep Blackstone reasonably informed
with respect thereto. Alnylam will not settle or compromise any allegation,
action or litigation in a way that admits fault or liability on the part of
Blackstone or otherwise results in any cost or liability on the part of
Blackstone.
ARTICLE 11
INDEMNIFICATION AND INSURANCE
11.1    Indemnification by Each Party.
11.1.1    By Blackstone. Blackstone will indemnify and hold Alnylam, its
Affiliates and its and their respective officers, directors, employees and
agents (the “Alnylam Indemnified Parties”) harmless from any and all Losses
arising or resulting from any Claims by a Third Party against any Alnylam
Indemnified Parties to the extent arising from (a) the
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gross negligence or willful misconduct of Blackstone in performing Blackstone’s
obligations under this Agreement; and (b) Blackstone’s material breach of this
Agreement; except to the extent that the foregoing (a) or (b) was caused by (i)
the gross negligence or willful misconduct of any Alnylam Indemnified Party, or
(ii) a material breach of this Agreement by Alnylam.
11.1.2    By Alnylam. Alnylam will indemnify and hold Blackstone, its
Affiliates, its investors and its and their respective officers, directors,
employees and agents (the “Blackstone Indemnified Parties”), harmless from any
and all Losses arising or resulting from any Claims by a Third Party against any
Blackstone Indemnified Parties to the extent arising from (a) a Product supplied
by or on behalf of Alnylam, its Affiliates or sublicensees; (b) a Product
Clinical Trial, including a physical injury or death of a Subject that is caused
by a Subject’s participation in a Product Clinical Trial, whether or not
directly attributable to a Product; (c) Alnylam’s gross negligence or willful
misconduct in performing its obligations under this Agreement; (d) Alnylam’s
material breach of this Agreement (e) the actions (or inactions) of a Permitted
Third Party, (f) any material breach of a Protocol by Alnylam, or its Affiliate,
or of its or their respective Permitted Third Parties, (g) actual or alleged
infringement of any Third Party’s Intellectual Property by a Product (including
its use or manufacture) or by either Party in performing its duties or
obligations hereunder with respect to a Product; and (h) injuries sustained by
Subjects in connection with the Product Clinical Trials, including Claims
arising prior to the Effective Date based upon physical injury or death of a
Subject in connection with the Product Clinical Trials, or from the
Commercialization of a Product; except to the extent that any of the foregoing
(a) through (h) were caused by (i) the gross negligence or willful misconduct of
any Blackstone Indemnified Party, or (ii) material breach of this Agreement by
Blackstone.
11.2    Indemnification Procedure.
11.2.1    Notice of Claim. A Party believing that it is entitled to
indemnification under Section 11.1.1 or 11.1.2 (an “Indemnified Party”) will
give prompt written notice (each, an “Indemnification Claim Notice”) to the
other Party (the “Indemnifying Party”) upon receipt of notice of the
commencement of any Claim for which indemnification may be sought, or if
earlier, upon the assertion of any such Claim by a Third Party (it being
understood and agreed, however, that the failure by an Indemnified Party to give
notice of a Claim of a Third Party as provided in this Section 11.2.1 will not
relieve the Indemnifying Party of its indemnification obligation under this
Agreement except and only to the extent that such Indemnifying Party is actually
prejudiced as a result of such failure to give notice). Each Indemnification
Claim Notice will contain a description of the Claim and the nature and amount
of the Loss (to the extent that the nature and amount of such Loss are known at
such time). The Indemnified Party will furnish promptly to the Indemnifying
Party copies of all papers and official documents received in respect of any
Losses.
11.2.2    Control of Defense. At its option, the Indemnifying Party may assume
the defense of any Claim by giving written notice to the Indemnified Party
within [***] after
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the Indemnifying Party’s receipt of an Indemnification Claim Notice. The
assumption of the defense of a Claim by the Indemnifying Party will not be
construed as an acknowledgment that the Indemnifying Party is liable to
indemnify the Indemnified Party in respect of the Claim, nor will it constitute
a waiver by the Indemnifying Party of any defenses it may assert against the
Indemnified Party’s claim for indemnification. Upon assuming the defense of a
Claim, the Indemnifying Party may appoint as lead counsel in the defense of the
Claim any legal counsel selected by the Indemnifying Party that is reasonably
satisfactory to the Indemnified Party. In the event the Indemnifying Party
assumes the defense of a Claim, the Indemnified Party will promptly deliver to
the Indemnifying Party all original notices and documents (including court
papers) received by the Indemnified Party in connection with the Claim. Should
the Indemnifying Party assume the defense of a Claim, the Indemnifying Party
will not be liable to the Indemnified Party for any legal expenses subsequently
incurred by such Indemnified Party in connection with the analysis, defense or
settlement of such Claim.
11.2.3    Right to Participate in Defense. Without limiting Section 11.2.2, the
Indemnified Party will be entitled to (a) participate in, but not control, the
defense of such Claim and to engage counsel of its choice for such purpose;
provided, however, that such engagement will be at the Indemnified Party’s own
expense unless the engagement thereof has been specifically authorized by the
Indemnifying Party in writing, and (b) control its defense of such Claim and to
engage counsel of its choice for such purpose, at the expense of the
Indemnifying Party, if the Indemnifying Party has failed to assume the defense
and engage counsel in accordance with Section 11.2.2.
11.2.4    Settlement. With respect to any Losses related solely to payment of
money damages in connection with a Claim that (a) includes a complete and
unconditional release of the Indemnified Party, (b) will not result in the
Indemnified Party admitting liability, becoming subject to injunctive or other
equitable relief that will otherwise adversely affect the business of the
Indemnified Party in any manner, and (c) as to which the Indemnifying Party will
have acknowledged in writing the obligation to indemnify the Indemnified Party
hereunder, the Indemnifying Party will have the sole right to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such
Loss, on such terms as the Indemnifying Party, in its sole discretion, will deem
appropriate. With respect to all other Losses in connection with Claims, where
the Indemnifying Party has assumed the defense of the Claim in accordance with
Section 11.2.2, the Indemnifying Party will have authority to consent to the
entry of any judgment, enter into any settlement or otherwise dispose of such
Loss, only if it obtains the prior written consent of the Indemnified Party
(which consent will not be unreasonably withheld, conditioned or delayed). The
Indemnifying Party will not be liable for any settlement or other disposition of
a Loss by the Indemnified Party that is reached without the written consent of
the Indemnifying Party (which consent will not be unreasonably withheld,
conditioned or delayed). Regardless of whether the Indemnifying Party chooses to
defend or prosecute any Claim, the Indemnified Party will not admit any
liability with respect to, or settle, compromise or discharge, any
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Claim without the prior written consent of the Indemnifying Party, not to be
unreasonably withheld or delayed.
11.2.5    Cooperation. Regardless of whether the Indemnifying Party chooses to
defend or prosecute any Claim, the Indemnified Party will reasonably cooperate
in the defense or prosecution thereof and will furnish such records, information
and testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested in
connection therewith. Such cooperation will include access during normal
business hours afforded to the Indemnifying Party to, and reasonable retention
by the Indemnified Party of, records and information that are reasonably
relevant to such Claim, and making employees and agents available on a mutually
convenient basis to provide additional information and explanation of any
material provided hereunder, and the Indemnifying Party will reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in connection
therewith.
11.3    Insurance.
11.3.1    Generally. Commencing as of the Effective Date and thereafter during
the Development Term, and subject to Section 11.3.2 below, Alnylam will carry
and maintain, at its own expense, insurance coverage of the kind and with
liability limits that, at a minimum, satisfy the requirements of Section 11.3.2,
to protect itself against any claims or liabilities that may arise from the
conduct of the Product Clinical Trials and all other rights and obligations
hereunder with insurers with a minimum “A-” A.M. Best rating. Any deductibles
for such insurance policies will be assumed by Alnylam. Prior to the Effective
Date, and annually, at each anniversary of the Effective Date (unless, during
such year, expiration of the applicable policy occurs first, in which case, on
such expiration date), at Blackstone’s written request, Alnylam will supply
documentation of such insurance coverage via original certificates of insurance,
if applicable. Alnylam will provide Blackstone with a minimum of [***] prior
written notice if it is unable to obtain appropriate insurance coverage or if
its coverage is canceled, unable to be renewed or materially changed. For
clarity, any insurance coverage or the failure to maintain adequate insurance
coverage does not limit or reduce Alnylam’s liability under this Agreement.
Alnylam will ensure that no subcontractor, including any Permitted Third Party,
will continue to perform the work unless such subcontractor is insured as deemed
appropriate by Alnylam.
11.3.2    Minimum Requirements. Commencing on the Effective Date and thereafter
during the Term (or longer if otherwise stated below), Alnylam will maintain the
following types of insurance coverage at a minimum level that is the greater of
(a) on a country-by-country basis, the minimum level required by Applicable Law
in the applicable country in which the Product Clinical Trials and other
obligations hereunder are being performed or (b) the following minimum amounts
(to the extent different).
11.3.2.1 Commercial General Liability: Five Million U.S. Dollars ($5,000,000)
per occurrence; Five Million U.S. Dollars ($5,000,000)
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Product and Completed Operations aggregate, including Premises & Operations,
Personal Injury, Product and Completed Operations; Five Million U.S. Dollars
($5,000,000) combined single limit on all owned, non-owned and hired vehicles of
Alnylam.
11.3.2.2 Umbrella Excess Liability: Eight Million U.S. Dollars ($8,000,000) per
occurrence.
11.3.2.3 Clinical Trials Liability: Ten Million U.S Dollars ($10,000,000) per
occurrence. Alnylam will obtain such Clinical Trials Liability insurance on a
global basis, and, if required, supplemented Clinical Trials Liability Insurance
in the US, at its expense. Coverage must be maintained for as long as required
by Applicable Law in each country after release of the last Subject from the
Product Clinical Trials or where there is no legal requirement at least five (5)
years after the termination of this Agreement.
11.3.2.4 Professional Liability: Any subcontractor, including any Permitted
Third Party, who provides professional services to Alnylam for the Product
Clinical Trials, will obtain Professional Liability Insurance in lieu of
Clinical Trial Insurance or will be covered by a global professional liability
policy maintained by Alnylam, in either case with a minimum limit of Two Million
U.S. Dollars ($2,000,000) per occurrence. Coverage must be maintained for at
least three (3) years after the later of (i) expiration or early termination of
this Agreement and (ii) release of the last Subject from the Product Clinical
Trials.
11.3.3    Product Liability Insurance. Alnylam will be responsible for
maintaining product liability insurance related to the Development and
Commercialization of the Products at its expense.
ARTICLE 12
REPRESENTATIONS AND WARRANTIES
12.1    Representations, Warranties and Covenants of Both Parties.
12.1.1    Each Party hereby represents and warrants that it has the requisite
corporate power and authority to enter into this Agreement and that this
Agreement constitutes a legal and valid obligation binding upon such Party,
enforceable in accordance with its terms.
12.1.2    Each Party hereby represents and warrants that it is not a party to
any agreement that would prevent it from fulfilling its obligations under this
Agreement.
12.1.3    Each Party hereby represents that the execution, delivery and
performance of this Agreement and each of the other Transaction Agreements have
been
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duly authorized by all necessary corporate or other organizational action, and
do not and will not (a) contravene the terms of any of such Person’s
organizational documents; (b) conflict with or result in any breach or
contravention of, or the creation of (or the requirement to create) any lien or
encumbrance under, or require any payment to be made under (i) any contractual
obligation to which such Person is a party or affecting such Person or the
properties of such Person or any of its subsidiaries (including, without
limitation, the Term Loan Agreement) or (ii) any order, injunction, writ or
decree of any governmental authority or any arbitral award to which such Person
or its property is subject; or (c) violate any Applicable Law, except in the
case of this Section 12.1.3 with respect to Alnylam, as would not reasonably be
expected to have a material adverse effect on Alnylam’s ability to satisfy its
obligations under this Agreement.
12.2    Additional Alnylam Representations, Warranties and Covenants. Alnylam
provides the following representations, warranties and covenants, in each case,
except as set forth in Exhibit F.
12.2.1    Licensure, Registration and Accreditation. Alnylam hereby represents
and warrants that it is licensed, registered, or otherwise qualified under all
Applicable Laws to do business in each jurisdiction where such licenses,
registrations or other qualifications are required, except as would not be
reasonably expected to have a Material Adverse Effect.
12.2.2    No Event of Default under Term Loan Agreement. Alnylam hereby
represents, warrants and covenants that to Alnylam’s Knowledge no “Event of
Default” (as such term is defined in the Term Loan Agreement) has occurred or
will occur.
12.2.3    Existing Licenses.
12.2.3.1 Maintenance of Existing Licenses. Alnylam represents and warrants that
there has not been, and covenants that there will not be during the Term, any
material breach or default by Alnylam under the Existing Licenses which has not
been or will not be, as applicable, timely cured as permitted thereunder, and
that the Existing Licenses are and will continue to be in full force and effect
during the Term. During the Term, Alnylam will: (a) not take any action that
would entitle an Existing Licensor to terminate any Existing License, (b)
promptly take such actions as are necessary to cure any breach that would
entitle an Existing Licensor to terminate an Existing License; and (c) not
amend, modify, supplement, restate, waive, cancel or terminate (or consent to
any cancellation or termination of), in whole or in part, any provision of or
right under the Existing Licenses, or assign, in whole or in part, the Existing
Licenses or any provision thereof or right thereunder, without the prior written
consent of Blackstone, such consent not to be unreasonably withheld, conditioned
or delayed. There are no circumstances that exist as of the Effective Date that
would reasonably be expected to give rise to a breach or default under any
Existing License by Alnylam, or to Alnylam’s Knowledge, by an Existing Licensor.
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12.2.3.2 [***]
12.2.3.3 No Other Agreements. Other than the Existing Licenses and the Term Loan
Agreement, there are no other agreements to which Alnylam is a party that are
related to, or pursuant to which Alnylam has obtained or granted rights
regarding, the Products.
12.2.4    Anti-Corruption. Alnylam agrees, on behalf of itself and its
Representatives, that for the performance of its obligations hereunder:
12.2.4.1 Alnylam, its Affiliates and its and their respective Representatives
will comply with the Anti-Corruption Laws and will not take any action that
will, or would reasonably be expected to, cause Blackstone or its Affiliates to
be in violation of any Anti-Corruption Laws; and
12.2.4.2 To the extent legally permitted, Alnylam will promptly provide
Blackstone with written notice of the following events: (a) upon becoming aware
of any material breach or violation by Alnylam, its Affiliate or any of its or
their respective Representatives of any representation, warranty or undertaking
set forth in Section 12.2.4.1, or (b) upon receiving a formal notification that
it is the target of a formal investigation by a Governmental Authority for a
Material Anti-Corruption Law Violation or upon receipt of information from any
of its Representatives connected with this Agreement that any of them is the
target of a formal investigation by a governmental authority for a Material
Anti-Corruption Law Violation.
12.2.5    Debarment. Alnylam hereby represents that neither it, nor its
Affiliates, nor to its Knowledge any Permitted Third Parties engaged by it to
perform activities in relation to the Products are debarred under subsections
306(a) or (b) of the U.S. Federal Food, Drug, and Cosmetic Act (US Generic Drug
Enforcement Act of 1992; 21 USC 335a (a) or (b)), and that it has not and will
not knowingly use in any capacity the services of any Person or Permitted Third
Party debarred under this law to conduct the Product Clinical Trials. Alnylam
further certifies that neither it, nor any of its Affiliates are excluded from
any federal health care program, including but not limited to Medicare and
Medicaid. Alnylam will notify Blackstone immediately if either of these
certifications needs to be amended in light of new information.
12.2.6    Clinical Trial Permits; Certifications; Authorizations. Alnylam
further covenants that it and its Permitted Third Parties have, or will have at
the required times, such INDs or other filings with all Regulatory Authorities
as are required to conduct the Product Clinical Trials and perform any and all
of their material obligations in connection with the Product Clinical Trials
supervised by it. All such INDs and other filings are valid and in full force
and effect. Alnylam has not received any notice that the FDA, other Regulatory
Authority, institutional review board or independent ethics committee, has
initiated, or
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threatened to initiate, any action to suspend or terminate any IND or otherwise
restrict the preclinical or clinical research of any Product.
12.2.7    Disclosure of Regulatory Notices and Communications. Alnylam hereby
represents and warrants that, as of the Effective Date, all material regulatory
communications and, if any, notices of inspection, inspection reports, warning
letters and deficiency letters related to the Products made available by Alnylam
in the Data Room were true and complete copies of such documents. Alnylam hereby
represents and warrants that such documents comprise all material written
regulatory communications related to the Products from all Regulatory
Authorities in the possession of Alnylam as of the Effective Date.
12.2.8    Serious Safety Issues. To Alnylam’s Knowledge, Alnylam has not
received any verbal or written notice of the occurrence of any Serious Safety
Issue in the Product Clinical Trials.
12.2.9    Compliance. Alnylam represents and warrants that, prior to the
Effective Date, (a) it has conducted all preclinical and clinical activities
related to the development of the Products in material compliance with
Applicable Laws, including GLP and GCP, and (b) to Alnylam’s Knowledge, all
Third Parties utilized by Alnylam to perform any portion of the preclinical and
clinical activities have conducted such portion of such preclinical activities
in material compliance with Applicable Laws. Alnylam will manufacture or have
manufactured the Products for the Product Clinical Trials in accordance with
GMP.
12.2.10    Intellectual Property. Alnylam hereby represents and warrants that,
as of the Effective Date, Alnylam owns or possesses sufficient legal rights to
all patents, trademarks, service marks, trade names, copyrights, trade secrets,
information, proprietary rights and processes necessary for the Development,
manufacture and Commercialization of the Products without, to Alnylam’s
Knowledge, any conflict with or infringement of the rights of any Third Party.
To Alnylam’s Knowledge, the Development, manufacture and Commercialization of
the Products by Alnylam does not violate and will not violate any license and
does not and will not infringe any intellectual property rights of any Third
Party. Except as set forth in the Existing Licenses, there are no outstanding
options, licenses or agreements of any kind granted by Alnylam relating to the
Development, manufacture or Commercialization of the Products. Alnylam has not
received any communications alleging that Alnylam has violated, or that the
Development, manufacture or Commercialization of the Products would violate, any
of the patents, trademarks, service marks, trade names, copyrights, trade
secrets or other proprietary rights of any Third Party. Schedule 12.2.10 hereto
sets forth an accurate and complete list of all issued patents and patent
applications included in the Alnylam Intellectual Property that, to Alnylam’s
Knowledge, cover or claim the Products or their use, manufacture or sale (the
“Product Patents”). For each Product Patent, Alnylam has indicated (i) the
jurisdiction in which such Patent Right is pending, allowed, granted or issued,
(ii) the patent number or patent application serial number, (iii) the
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owner of such Patent, and (iv) the expiration date of such Patent. To Alnylam’s
Knowledge, the Product Patents that have been issued or granted by the
applicable patent office are valid and enforceable, and Alnylam has not received
any written notice or legal opinion, whether preliminary in nature or qualified
in any manner, which concludes that a challenge to the validity or
enforceability of any of the issued Product Patents may succeed. Alnylam has not
received any claim or notice challenging, or threatening to challenge, the
ownership of, or rights of Alnylam in and to or the validity or enforceability
of the Product Patents. To Alnylam’s Knowledge, Alnylam has not committed any
act, or failed to commit any required act that would reasonably be expected to
cause any Product Patent to expire prematurely, lapse or be declared invalid or
unenforceable, or that estops the enforcement of such Product Patent against any
Third Party.
12.2.11    Alnylam Data Provided as of the Effective Date. Alnylam hereby
represents and warrants that, up to and as of the Effective Date, (i) the CMC
Information set forth in the Data Room is accurate in all material respects,
(ii) the descriptions of, Protocols for, and data and other results of, the
Product Clinical Trials conducted by or on behalf of Alnylam set forth in the
Data Room are accurate in all material respects and (iii) the summaries of
primary data regarding the Products set forth in the Data Room are accurate in
all material respects.
12.3    Blackstone Representation, Warranty and Covenant. Blackstone hereby
represents, warrants and covenants that it will have, as and when needed,
sufficient funds to satisfy its obligations hereunder.
12.4    DISCLAIMER OF REPRESENTATIONS AND WARRANTIES.
12.4.1    Each Party hereby agrees and understands that because the Product
Clinical Trials and the Products are experimental in nature, the outcome is
inherently uncertain and unpredictable. Each Party hereby agrees and understands
that the other Party makes no representation, guarantee or warranty, express or
implied, regarding the outcome of the Product Clinical Trials (including
achievement of the Phase 2 Success Criteria, the Phase 3 Success Criteria or the
Success Payment Triggers), any Research Results generated after the Effective
Date, the ability to obtain Regulatory Approval or the patentability, legal
protectability or usefulness of any Intellectual Property arising from the
Product Clinical Trials.
12.4.2    EXCEPT AS OTHERWISE SET FORTH IN THIS Article 12, NEITHER PARTY MAKES,
AND EACH PARTY EXPRESSLY DISCLAIMS, ANY REPRESENTATION OR WARRANTY OF ANY KIND
WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT, EITHER ORAL OR WRITTEN,
EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING ANY REPRESENTATION OR
WARRANTY REGARDING THE USE, RESULTS OR EFFICACY OF THE PRODUCTS.
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ARTICLE 13
TERM; CLOSING CONDITIONS; AND TERMINATION
13.1    Term. The term of this Agreement (the “Term”) will commence on the
Effective Date and will expire upon the earliest of (i) termination of this
Agreement in accordance with Section 13.3, or (ii) the date of payment of the
later of the last Success Payment or Royalty payment.
13.2    Pre-Signing Conditions.
13.2.1    IP Security Agreement. On or before the Effective Date, Alnylam will
(a) execute and deliver to Blackstone an IP Security Agreement(s) as set forth
in Section 7.4.1(a), (b) record such agreement with the U.S. Patent and
Trademark Office and provide sufficient evidence to Blackstone that such
filing(s) have been made, and (c) take such other action as may be necessary or
as Blackstone may reasonably request to perfect Blackstone’s security interest
in any Intellectual Property of Alnylam in existence as of the Effective Date
constituting Blackstone Collateral.
13.2.2    Intercreditor Agreement. On or before the Effective Date, Blackstone
and Wilmington Trust as the Collateral Agent will enter into the Intercreditor
Agreement, which Intercreditor Agreement will be acknowledged and consented to
by Alnylam.
13.2.3    Proof of Insurance. Prior to the Effective Date, Alnylam will supply
documentation of insurance coverage via original certificates of insurance, if
applicable, in accordance with Section 11.3.
13.2.4    Opinion. On the Effective Date, Alnylam will deliver to Blackstone an
executed opinion of counsel, dated as of the date hereof, solely with respect to
the creation of a security interest in the Blackstone Collateral and the
perfection of such security interest upon the proper filing of a UCC-1 financing
statement.
13.3    Termination.
13.3.1    Termination for Breach.
13.3.1.1 Generally. Either Party may terminate this Agreement immediately,
either in its entirety or with respect to a Product, in the event of a material
breach of this Agreement by the other Party provided that the breaching Party
has received written notice from the non-breaching Party of such breach,
specifying in reasonable detail the particulars of the alleged breach and such
breach has not been cured within [***] after the date of the relevant notice.
The non-breaching Party will have the right to pursue remedies it may have at
law or equity for such breach, including the right to seek damages from the
breaching Party. For the avoidance of doubt, a breach by Alnylam of applicable
Anti-Corruption
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Laws will be considered a material breach of this Agreement for which Blackstone
will have a termination right under this Section 13.3.1.
13.3.1.2 By Blackstone. In the event that Blackstone terminates this Agreement
pursuant to this Section 13.3.1 then Alnylam will pay Blackstone, within [***]
of the date of termination, an amount equal to the full MoIC of Development
Costs actually paid by Blackstone for the terminated Product(s) prior to the
effective date of such termination. If Alnylam elects to continue Development of
the terminated Product(s) and obtains Regulatory Approval following such
termination, Alnylam will remain obligated to pay to Blackstone the Royalty (as
applicable) for the terminated Product(s) that become due and payable pursuant
to Section 6.1.1.2 at such time as such Royalty payments become due and payable
(if ever).
13.3.1.3 By Alnylam. In the event that Alnylam terminates this Agreement
pursuant to this Section 13.3.1 then all payment obligations of Alnylam
hereunder, including pursuant to Article 6, shall terminate as of the date of
such termination, and Alnylam will not be required to make any payment to
Blackstone with respect to any Development Costs paid by Blackstone for the
terminated Product(s).
13.3.2    Termination by Blackstone for Material Adverse Event. Blackstone may
terminate this Agreement, in its entirety or with respect to a Product, at any
time in the event that either subsection (a) or (b) of the definition of
Material Adverse Event is met, immediately upon written notice to Alnylam. In
the event that Blackstone terminates this Agreement pursuant to this Section
13.3.2, then, Alnylam will pay Blackstone an amount equal to one-hundred percent
(100%) of the Development Costs actually paid by Blackstone for the terminated
Product(s) as of the effective date of such termination. For clarity, Alnylam
will not be obligated to pay to Blackstone any Success Payments or Royalties for
the terminated Product(s) following the effective date of such termination.
13.3.3    Termination for Failure to Receive Regulatory Approval.
13.3.3.1 Failure to Obtain Regulatory Approval. This Agreement will, upon
written notice from either Party to the other Party, terminate with respect to
one or both Products (as applicable) with no further action from either Party,
if the applicable Product(s) has not received Regulatory Approval in any Major
Market Country following completion of the Product Clinical Trials for such
Product(s), Alnylam’s submission of applications for Regulatory Approval in the
Major Market Countries, and Alnylam’s use of Commercially Reasonable Efforts to
obtain such Regulatory Approvals. For the avoidance of doubt, if Regulatory
Approval is received in any Major Market Country, then this Agreement may not
thereafter be terminated pursuant to this Section 13.3.3.1.
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13.3.3.2 Development Program Failure. Blackstone will have the right to
terminate this Agreement upon written notice to Alnylam with respect to one or
both Products (as applicable) with no further action from either Party with
respect to the applicable Product, if (a) the JSC elects to discontinue such
Development Program in its entirety, or (b)(i) with respect to Vutrisiran, the
HELIOS-B Trial, or (ii) with respect to ALN-AGT, the ALN-AGT Phase 2 Trial or
the ALN-AGT Phase 3 Trial, is completed or terminated and either (A) the primary
endpoint in such trial is not achieved, or (B) Blackstone reasonably determines
that the Research Results of such trial do not support Regulatory Approval. For
the avoidance of doubt, if an application for Regulatory Approval of a Product
is accepted for filing by a Regulatory Authority in any Major Market Country
then this Agreement may not thereafter be terminated pursuant to this Section
13.3.3.2 for such Product.
13.3.3.3 In the event that this Agreement is terminated pursuant to this Section
13.3.3, then, if Alnylam elects to continue Development of the terminated
Product(s) and obtains Regulatory Approval in a Major Market Country following
such termination, Alnylam will remain obligated to pay to Blackstone the Royalty
(as applicable) and make any Success Payments for such terminated Product(s)
that become due and payable pursuant to Article 6 at such time that such
payments become due and payable (if ever) pursuant to Article 6, provided that
such Success Payments will be adjusted as set forth in Section 6.2.
13.3.4    Termination for Bankruptcy. Either Party may terminate this Agreement
in its entirety upon written notice to the other Party if the other Party makes
an assignment for the benefit of creditors, or commences a case or proceeding
under any bankruptcy, reorganization, insolvency, or similar laws, has a trustee
or receiver or similar officer of any court appointed for such Party, or for
substantial part of the property of such Party, or bankruptcy, reorganization,
insolvency, or liquidation proceedings are instituted by or against such Party
without such proceedings being dismissed, in each of the foregoing cases for a
period of at least [***].
13.3.4.1 In the event that Alnylam terminates this Agreement pursuant to this
Section 13.3.4, then, if Alnylam elects to continue Development of either or
both Products and obtains Regulatory Approval following such termination for
either or both Products, then Alnylam will remain obligated to pay to Blackstone
the Royalty (as applicable) and any Success Payments for the applicable
Product(s) that become due and payable pursuant to Article 6 at such time as
such Success Payments become due and payable (if ever) pursuant to Article 6,
provided that such Success Payments will be adjusted as set forth in Section
6.2.
13.3.4.2 In the event that Blackstone terminates this Agreement pursuant to this
Section 13.3.4, then, Alnylam will pay Blackstone within [***] of the date of
termination [***]. If Alnylam elects to continue Development of
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the terminated Product(s) and obtains Regulatory Approval following such
termination, Alnylam will remain obligated to pay the Royalty (as applicable)
for the terminated Product(s) that become due and payable pursuant to Article 6
at such time as such Royalty payments become due and payable (if ever) pursuant
to Article 6.
13.3.5    Termination for a Licensing Transaction or Change of Control of
Alnylam. Blackstone may, in its sole discretion, terminate this Agreement in its
entirety or with respect to the applicable Product at any time within [***]
following (a) a determination pursuant to Section 3.8 that a Change of Control
of Alnylam that occurs prior to the date of payment by Alnylam of the final
applicable Success Payment owed to Blackstone pursuant to Article 6 will have a
Material Impact, or (b) a determination by the arbitrator pursuant to
Section 3.7 that a Licensing Transaction will have a Material Impact. In the
event that Blackstone terminates this Agreement pursuant to this Section 13.3.5,
Alnylam will pay to Blackstone within [***] of the date of termination [***].
Alnylam or its successor or licensee (whose performance will be guaranteed by
Alnylam) will be obligated to continue to exercise Commercially Reasonable
Efforts to Develop the Products as set forth herein. If, following such Change
of Control or Licensing Transaction, Regulatory Approval is obtained for a
Product, then Alnylam (or its successor or licensee) will remain obligated to
pay the Royalty (as applicable) and any Success Payments that become due and
payable pursuant to Article 6 at such time as such Success Payments become due
and payable (if ever) pursuant to Article 6 (except to the extent that Alnylam
has accelerated any such payments pursuant to Section 6.6), provided that such
Success Payments will be adjusted as set forth in Section 6.2, and will be
reduced by the amount previously paid to Blackstone as set forth in this Section
13.3.5.
13.3.6    Termination for Safety Concerns. Either Party may terminate this
Agreement with respect to a Product upon written notice to the other Party if
(a) the IDMC for a Product Clinical Trial recommends termination of such Product
Clinical Trial for reasons pertaining to the health or safety of the Subjects or
for futility, or (b) the Parties mutually agree that a material health or safety
concern with respect to the Subjects exists. In the event that this Agreement
terminates pursuant to this Section 13.3.6, then if Alnylam elects to continue
Development of the terminated Product(s) and obtains Regulatory Approval in a
Major Market Country following such termination, Alnylam will remain obligated
to pay to Blackstone the Royalty (as applicable) and make any Success Payments
for such terminated Product(s) that become due and payable pursuant to Article 6
at such time that such payments become due and payable (if ever) pursuant to
Article 6, provided that such Success Payments will be adjusted as set forth in
Section 6.2. Notwithstanding the foregoing, if this Agreement terminates
pursuant to this Section 13.3.6 and such termination: (i) arises as a result of
gross negligence on the part of Alnylam; or (ii) is due to (x) the applicable
IDMC recommending termination of the applicable Product Clinical Trial or (y)
Alnylam and Blackstone mutually agreeing to terminate the applicable Product
Clinical Trial, in either case ((x) or (y)), due to a Serious Safety Issue that
was previously known,
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demonstrated or identified by Alnylam as being material as of the Effective Date
and the material data showing, demonstrating, or identifying such Serious Safety
Issue were not included in the Data Room, disclosed in writing to Blackstone or
otherwise publicly known prior to the Effective Date; then, in either case ((i)
or (ii)), Alnylam will pay Blackstone within [***] of the date of termination
[***] and if Alnylam elects to continue the Development of the terminated
Product(s) and obtains Regulatory Approval for such terminated Product(s)
following such termination, then Alnylam will remain obligated to pay to
Blackstone the Royalty (as applicable) for the terminated Product(s) that
becomes due and payable pursuant to Article 6 at such time as such Royalty
payments become due and payable (if ever) pursuant to Article 6.
13.3.7    Termination Because of Adverse Patent Impact. Blackstone may terminate
this Agreement, solely with respect to Vutrisiran, if Alnylam is enjoined from
further Developing or Commercializing Vutrisiran in any of the Major Market
Countries based on an allegation that Vutrisiran infringes a patent of a Third
Party (an “Adverse Patent Impact”), upon written notice to Alnylam if Alnylam
does not cure such Adverse Patent Impact within a period of [***] from the date
of Blackstone’s notice to Alnylam of an Adverse Patent Impact. In the event that
Blackstone terminates this Agreement pursuant to Section 13.3.7, then Alnylam
will pay Blackstone within [***] of the date of termination [***] provided that,
Alnylam will remain obligated to pay the Royalty that becomes due and payable
pursuant to Section 6.1.1.2 at such time as such Royalties become due and
payable (if ever) pursuant to Section 6.1.1.2 (except to the extent that Alnylam
has repurchased any such payments pursuant to Section 6.6.2).
13.4    Additional Consequences of Termination.
13.4.1    Release of Security Interest. Upon any termination of this Agreement
and payment by Alnylam of all amounts specified as being payable upon such
termination in Section 13.3 (other than a termination pursuant to Section
13.3.2, in which case Blackstone’s security interest will not be released until
the earlier of such time as conditions exist that would have permitted this
Agreement to be terminated under Section 13.3.3 or 13.3.5 in the absence of such
termination under Section 13.3.2 or such time as Alnylam has made all Success
Payments that become payable pursuant to 13.3.2) excluding Success Payment
amounts, Blackstone will and hereby does release the security interest granted
by Alnylam to Blackstone pursuant to Article 7. Blackstone agrees to sign such
further releases and other documents and take such further actions as may be
necessary or desirable, in Alnylam’s reasonable judgment and at Alnylam’s
request, to more fully give effect to such release.
13.4.2    [***]
13.5    Surviving Obligations.
13.5.1    Accrued Rights and Obligations. Expiration or termination of this
Agreement for any reason will not release either Party from any obligation or
liability which,
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at the time of such expiration or termination, has already accrued to the other
Party or which is attributable to a period prior to such expiration or
termination.
13.5.2    Surviving Obligations. The following provisions of this Agreement,
together with any other provisions that expressly specify that they survive,
will survive expiration or earlier termination of this Agreement: Article 1,
Article 6 (but only following termination (not expiration) and only to the
extent payments of Success Payments and Royalties are contemplated following
such termination in accordance with the terms of the applicable subsection of
Section 13.3), Article 7 (such provisions surviving only until such time as the
security interest granted by Alnylam to Blackstone pursuant to Article 7 is
released, whether pursuant to Section 13.4.1 or otherwise, provided that the
survival of Section 7.5 shall be as set forth in Section 7.5.11), Article 8
(other than Section 8.2), Article 9, Article 11, Section 10.1, Section 13.3 (to
the extent relating to post-termination rights and obligations of the Parties),
Section 13.4, Section 13.5, Section 14.3, Section 14.4, Section 14.5, Section
14.6, Section 14.9, Section 14.10, Section 14.11, Section 14.12, Section 14.14,
Section 14.17, Section 14.20.
ARTICLE 14
MISCELLANEOUS
14.1    Relationship with Affiliates. Each Party will be responsible for any
breach by its Affiliates of its obligations in connection with this Agreement,
and each such Party will remain responsible for any responsibilities that it has
delegated to an Affiliate as though such Party had performed (or failed to
perform) such responsibilities itself.
14.2    Prior Agreements. The Parties hereby agree that the Confidentiality
Agreement is hereby terminated and superseded by this Agreement and that all
Information related to the Product(s) disclosed under or pursuant to the
Confidentiality Agreement will constitute Confidential Information disclosed
pursuant to this Agreement and will be subject to the terms of Article 9, with
the confidentiality and non-use provisions of Article 9 applying retroactively
to such Confidential Information from the date of disclosure.
14.3    Notices. Any notice or other communication required or permitted to be
given by either Party under this Agreement will be in writing and will be
effective when delivered if delivered by fax, e-mail, hand, reputable courier
service, or five (5) days after mailing if mailed by registered or certified
mail, postage prepaid and return receipt requested, addressed to the other Party
at the following addresses or such other address as may be designated by notice
pursuant to this Section 14.3:
14.3.1    If to Alnylam:
Alnylam Pharmaceuticals, Inc.
675 West Kendall Street, Henri A. Termeer Square
Cambridge, MA 02142
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Attn: Jeff Poulton
[***]
with a copy, which will not constitute notice, to:
Alnylam Pharmaceuticals, Inc.
675 West Kendall Street, Henri A. Termeer Square
Cambridge, MA 02142
Attn: Laurie Keating
[***]
And to:
Goodwin Procter LLP
601 Marshall Street
Redwood City, CA 94063
Attn: Shane Albright
[***]
14.3.2    If to Blackstone:
BXLS V Bodyguard – PCP L.P.
c/o Blackstone Life Sciences
101 Main Street
Suite 1210
Cambridge, MA 02142
Attn: Craig Shepherd
[***]
with a copy, which will not constitute notice, to:
Blackstone Life Sciences
101 Main Street
Suite 1210
Cambridge, MA 02142
Attn: Julie Constable
[***]
And to:
Ropes & Gray LLP
800 Boylston Street
Prudential Tower
Boston, MA 02199
Attn: Michael Beauvais
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[***]

14.4    Force Majeure. Neither Party will be liable for any breach or delay in
performance of any obligation under this Agreement to the extent caused by any
of the following: war, terrorism, riot, fire, explosion, accident, flood,
earthquake, storm or other catastrophe, epidemic, pandemic (including with
respect to COVID-19), voluntary or involuntary compliance with any regulation,
law or order of any government (including quarantine, shelter-in-place,
cessation of business activity, or similar or related directive), any other
public health crisis, failure or default of public utilities or common carriers,
destruction of production facilities, civil commotion, strike or lockout,
sabotage, changes in Applicable Laws, actions of Governmental Authorities, or
any other event beyond the reasonable control of such Party (each, a “Force
Majeure Event”). The Party invoking this Section 14.4 must provide prompt
written notice and full particulars of such event to the other Party and will
use diligent and commercially reasonable efforts to mitigate the effects of any
such Force Majeure Event on such Party’s compliance with and performance under
this Agreement.
14.5    Use of Names. Except as required by Applicable Law, neither Party will
use the other Party’s nor any of its Affiliates’ (including the limited partners
of Blackstone’s or its Affiliates’, Representatives, partners, managers,
directors, board members, members, officers, funds, employees or agents) names
or trademarks (including, with respect to Blackstone, any reference to
“Blackstone” or “The Blackstone Group”) in any promotional materials,
advertising, marketing, endorsement, promotional or sales literature, publicity,
public announcement or disclosure in any document employed to obtain funds or
financing without the prior written consent of the other Party except as
otherwise expressly permitted in this Agreement or as required by Applicable
Law. Notwithstanding the foregoing, Blackstone may use the name, logos, and
other insignia of Alnylam in any “tombstone” or other advertisements, in its
publications, marketing or promotional materials to existing and prospective
investors and otherwise on the website or in other marketing materials of
Blackstone, as applicable, without Alnylam’s prior approval.
14.6    Assignment. The provisions of this Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their respective successors and
permitted assigns. Except as permitted herein, Alnylam may not assign, delegate
or otherwise transfer this Agreement or any of its interests, obligations or
rights hereunder without the prior written consent of Blackstone, and any such
purported assignment, delegation or transfer without such consent will be void
ab initio and of no effect, provided that Alnylam may assign this Agreement,
without such consent of Blackstone, to an Affiliate or to any Third Party that
acquires all or substantially all of Alnylam’s business, whether by merger, sale
of assets or otherwise, as long as such assignee agrees in a writing to be bound
by all the provisions of this Agreement as if such assignee were Alnylam under
this Agreement. Alnylam shall give notice to Blackstone of any assignment for
which consent was not
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required by Blackstone promptly after the occurrence thereof, and, in the case
of an assignment to an Affiliate, Alnylam shall remain liable to Blackstone for
its obligations to Blackstone hereunder (and Blackstone shall be entitled to
seek recovery for any breach or default of an obligation hereunder from Alnylam
or from such Affiliate assignee). Blackstone may assign any of its obligations
and rights hereunder, without restriction and without the consent of Alnylam if
(a) Blackstone notifies Alnylam at least [***] prior to any such assignment, (b)
any such assignee, as a condition precedent to such assignment, agrees in
writing with Alnylam to be bound by the obligations of Blackstone contained in
this Agreement, (c) notwithstanding any such assignment, Blackstone remains
liable to Alnylam for its obligations to Alnylam hereunder (and Alnylam shall be
entitled to seek recovery for any breach or default of an obligation hereunder
from Blackstone or from such assignee) and (d) in any event, such assignment
shall be of the Agreement in its entirety. Notwithstanding the foregoing,
Blackstone may assign its right to receive Success Payments in whole or in part,
without restriction and without the consent of Alnylam.
14.7    Further Assurances. The Parties will execute such further reasonable
documents and perform such further reasonable acts as may be necessary to comply
with or more fully effectuate the terms of this Agreement.
14.8    Fees and Expenses. Each Party to this Agreement will bear its own costs
and expenses, including attorneys’ fees and expenses, in connection with the
closing of the transactions contemplated hereby. Following a breach or default
hereunder by Alnylam, Alnylam shall reimburse Blackstone for its costs and
expenses (including legal fees) incurred in collecting the Alnylam Obligations,
enforcing the Blackstone Security Interests, or in connection with any
bankruptcy or insolvency proceeding commenced by or against Alnylam.
14.9    Governing Law. The construction and validity of this Agreement and the
provisions hereof, and the rights and obligations of the Parties hereunder, will
be governed by the internal laws of the State of New York, and, to the extent
applicable to Patents and Trademarks, the applicable federal laws of the U.S.,
in each instance without regard to conflict of laws principles.
14.10    Dispute Resolution. The Parties recognize that disputes as to certain
matters relating to this Agreement may arise from time to time. It is the
objective of the Parties to establish procedures to facilitate the resolution of
disputes in an expedient manner by mutual cooperation and without resort to
litigation. Accordingly, the Parties agree that any dispute, controversy or
claim arising under, out of or in connection with this Agreement, including any
subsequent amendments, or the validity, enforceability, construction,
performance or breach hereof (and including the applicability of this Section
14.10 to any such dispute, controversy or claim) (each a “Dispute”) will be
resolved exclusively as follows:
14.10.1    Either Party will have the right to refer such Dispute to the
Executive Officers for attempted resolution by good faith negotiations for a
period of [***].
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Any final decision mutually agreed to by the Executive Officers in writing will
be conclusive and binding on the Parties. With respect to any Dispute that
remains unresolved after the expiration of [***] after a Dispute is notified to
the Executive Officers, then such Dispute will be submitted by the Party seeking
to resolve such dispute to the AAA for final and binding arbitration pursuant to
the arbitration clause set forth in Section 14.10.2. Notwithstanding the
foregoing, no matters relating to breach or alleged breach of the ownership of
Intellectual Property or rights in Intellectual Property or the validity or
enforceability thereof will be resolved by arbitration, but rather will be
determined by a U.S. federal court of appropriate jurisdiction in New York, New
York, or, in the absence of federal court jurisdiction, the state courts of the
State of New York. Notwithstanding the foregoing, any dispute between the
Parties as to whether entering into a Licensing Transaction would have a
Material Impact will be resolved as set forth in Section 3.7. Notwithstanding
anything in this Agreement to the contrary, either Party will be entitled to
seek preliminary injunctive relief in any court of competent jurisdiction
immediately if necessary to prevent irreparable harm to that Party.
14.10.2    Arbitration Process.
14.10.2.1 Either Party will have the right to initiate arbitration at any time
after the expiration of [***] after a Dispute is notified to the Executive
Officers. Any disputes concerning the propriety of the commencement of the
arbitration will be finally settled by the arbitral tribunal.
14.10.2.2 Any Dispute including the determination of the scope or applicability
of this agreement to arbitrate, will be determined by arbitration in New York in
the English language. The arbitration will be administered by the AAA pursuant
to its arbitration rules and procedures. References herein to any arbitration
rules or procedures mean such rules or procedures as amended from time to time,
including any successor rules or procedures, and references herein to the AAA
include any successor thereto. The arbitration will be before a tribunal
comprised of three (3) arbitrators. Each Party will select one arbitrator and
within [***] of the second arbitrator’s appointment, the two (2) Party appointed
arbitrators will select the third, who will serve as the tribunal’s chair or
president. All three (3) arbitrators will be professionals with substantial
experience in development and Commercialization of biopharmaceutical products.
An arbitrator will be deemed to meet these qualifications unless a Party objects
within [***] after the arbitrator is appointed. This arbitration provision, and
the arbitration itself, will be governed by the Federal Arbitration Act, 9
U.S.C. §§ 1 et. seq.
14.10.2.3 Consistent with the expedited nature of arbitration, each Party will,
upon the written request of the other Party, promptly provide the other with
copies of documents on which the producing Party may rely in support of or in
opposition to any claim or defense. At the request of a Party, the arbitrators
will have the discretion to order examination by deposition of witnesses to the
extent
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the arbitrator deems such additional discovery relevant and appropriate.
Depositions will be limited to a maximum of [***] per Party and will be held
within [***] after the grant of a request. Additional depositions may be
scheduled only with the permission of the arbitrators, and for good cause shown.
Each deposition will be limited to a maximum of [***]. All objections are
reserved for the arbitration hearing except for objections based on privilege
and proprietary or confidential information. The Parties will not utilize any
other discovery mechanisms, including international processes and U.S. federal
statutes, to obtain additional evidence for use in the arbitration. Any Dispute
regarding discovery, or the relevance or scope thereof, will be determined by
the arbitrators, which determination will be conclusive. All discovery will be
completed within [***] following the appointment of the arbitrators. All costs
or fees relating to the retrieval, review and production of electronic discovery
will be paid by the Party requesting such discovery.
14.10.2.4 The arbitrators will have no authority to award punitive or other
damages not measured by the prevailing Party’s actual damages, except as may be
required by statute. Each Party expressly waives and foregoes any right to
consequential, punitive, special, exemplary or similar damages or lost profits.
The arbitrators will have no power or authority to relieve the Parties from
their agreement hereunder to arbitrate or otherwise to amend or disregard any
provision of this Agreement. The cost of the arbitration, including the fees of
the arbitrators and reasonable attorney’s fees of the prevailing Party, will be
borne by the Party the arbitrator determines has not prevailed in the
arbitration.
14.10.2.5 If an arbitral award does not impose an injunction on the losing Party
or contain a money damages award in excess of [***] then the arbitral award will
be final and binding and will only be subject to such challenges as would
otherwise be permissible under the Federal Arbitration Act, 9 U.S.C. § 1 et.
seq. Judgment on such an award may be entered in any court of competent
jurisdiction and the Parties undertake to carry out the award without delay. In
the event that an arbitral award imposes an injunction or contains a monetary
award in excess of [***] the Parties agree that such award may be appealed
pursuant to the AAA’s Optional Appellate Arbitration Rules (the “Appellate
Rules”) and should not be considered to be final and binding until after the
time for filing the notice of appeal under the Appellate Rules has expired.
Appeals must be initiated within [***] of receipt of the award, as defined by
the Appellate Rules, by filing a Notice of Appeal within any AAA office.
Following the appeal process, the decision rendered by the appeal tribunal will
be final and binding and judgment on that award may be entered in any court of
competent jurisdiction and the Parties undertake to carry out the award without
delay.
14.10.2.6 Except as may be required by law, or to protect or pursue a legal
right to enforce or challenge an award in legal proceedings, where needed for
the preparation or presentation of a claim or defense in this arbitration, or
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by order of the arbitral tribunal upon application of a Party, neither a Party
nor an arbitrator may disclose the existence, content, or results of any
arbitration hereunder without the prior written consent of both Parties.
14.11    Limitation of Liability. TO THE MAXIMUM EXTENT PERMITTED BY LAW AND
NOTWITHSTANDING ANY PROVISION IN THIS AGREEMENT TO THE CONTRARY, NEITHER PARTY
WILL BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL,
RELIANCE OR PUNITIVE DAMAGES OR LOST OR IMPUTED PROFITS OR ROYALTIES OR COST OF
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, WHETHER LIABILITY IS ASSERTED IN
CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCTS LIABILITY), INDEMNITY
OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF
THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE
POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE. THE PARTIES AGREE THAT THE LIMITATIONS
SPECIFIED IN THIS SECTION 14.11 WILL APPLY EVEN IF ANY LIMITED REMEDY SPECIFIED
IN THIS AGREEMENT IS FOUND TO HAVE FAILED OF ITS ESSENTIAL PURPOSE. FOR THE
AVOIDANCE OF DOUBT, THIS SECTION 14.11 WILL NOT LIMIT (A) ALNYLAM’S OBLIGATION
TO PAY BLACKSTONE THE AMOUNTS SET FORTH IN ARTICLE 6 OR SECTION 13.3, OR (B) A
PARTY’S LIABILITY RESULTING FROM SUCH PARTY’S (I) GROSS NEGLIGENCE, FRAUD OR
WILLFUL MISCONDUCT, (II) BREACH OF Article 9, OR (III) INDEMNIFICATION
OBLIGATION PURSUANT TO SECTION 11.1.
14.12    Cumulative Remedies. Unless expressly set forth in this Agreement, all
rights and remedies of the Parties, including all rights to payment, rights of
termination, rights to injunctive relief, and other rights provided under this
Agreement, will be cumulative and in addition to all other remedies provided for
in this Agreement, in law, and in equity.
14.13    Relationship of the Parties; Independent Contractors. Nothing contained
herein will be deemed to create a partnership, joint venture, or similar
relationship between the Parties, including for U.S. federal income and other
applicable tax purposes. Neither Party is the agent, employee, joint venturer,
partner, franchisee, or representative of the other Party. Each Party
specifically acknowledges that it does not have the authority to, and will not,
incur any obligations or responsibilities on behalf of the other Party.
Notwithstanding anything to the contrary in this Agreement, each Party (and its
officers, directors, agents, employees, and members) will not hold themselves
out as employees, agents, representatives, or franchisees of the other Party or
enter into any agreements on such Party’s behalf.
14.14    No Third Party Beneficiaries. This Agreement and the provisions herein
are for the benefit of the Parties only, and are not intended to confer any
rights or benefits to any Third Party.
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14.15    Rights Reserved. No license or any other right is granted to either
Party, by implication or otherwise, except as specifically set forth in this
Agreement. All rights not exclusively granted to Blackstone are reserved to
Alnylam and its Affiliates. Notwithstanding any other provision of this
Agreement to the contrary, and for clarity, no Intellectual Property or other
proprietary rights Controlled by Alnylam or its Affiliates will be assigned or
licensed to Blackstone in connection with this Agreement.
14.16    Amendments; No Waiver. Unless otherwise specified herein, no amendment,
supplement, or modification of this Agreement will be binding on either Party
unless it is in writing and signed by both Parties. No delay or failure on the
part of a Party in the exercise of any right under this Agreement or available
at law or equity will be construed as a waiver of such right, nor will any
single or partial exercise thereof preclude any other exercise thereof. All
waivers must be in writing and signed by the Party against whom the waiver is to
be effective. Any such waiver will constitute a waiver only with respect to the
specific matter described in such writing and will in no way impair the rights
of the Party granting such waiver in any other respect or at any other time.
14.17    Severability. If any provision (or portion thereof) of this Agreement
is determined by a court or arbitration to be unenforceable as drafted by virtue
of the scope, duration, extent, or character of any obligation contained herein,
it is the Parties’ intention that such provision (or portion thereof) will be
construed in a manner designed to effectuate the purposes of such provision to
the maximum extent enforceable under such Applicable Law. The Parties will enter
into whatever amendment to this Agreement as may be necessary to effectuate such
purposes.
14.18    Entire Agreement. This Agreement, including all Exhibits hereto and the
Transaction Agreements, contains the entire understanding of the Parties and
supersedes, revokes, terminates, and cancels any and all other arrangements,
understandings, agreements, term sheets, or representations and warranties,
whether oral or written, between the Parties relating to the subject matter of
this Agreement.

-87-

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14.19    Counterparts. This Agreement will be executed in two (2) counterparts,
one (1) for either Party, which, taken together, will constitute one and the
same agreement. This Agreement will not be binding on the Parties or otherwise
effective unless and until executed by both Parties.
14.20    Construction. This Agreement has been negotiated by the Parties and
their respective counsel. This Agreement will not be construed in favor of or
against either Party by reason of the authorship of any provisions hereof.
[Signature Page Follows]

-88-

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IN WITNESS WHEREOF, the Parties, intending to be legally bound hereby, have
caused this Agreement to be executed in duplicate by their duly authorized
representatives as of the Effective Date.

ALNYLAM PHARMACEUTICALS, INC.

By: /s/ Yvonne Greenstreet____________
            Name: Yvonne Greenstreet
            Title: Chief Operating Officer
Date: __8/14/2020____________________

Signature Page To The Co-Development Agreement

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IN WITNESS WHEREOF, the Parties, intending to be legally bound hereby, have
caused this Agreement to be executed in duplicate by their duly authorized
representatives as of the Effective Date.

BXLS V BODYGUARD – PCP L.P.

By: Blackstone Life Sciences Advisors L.L.C. on behalf of Blackstone Life
Sciences Associates V (CYM) L.L.C.

By: /s/ Robert Liptak_________________
            Name: Robert Liptak
            Title: Authorized Person

Signature Page To The Co-Development Agreement

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IN WITNESS WHEREOF, the Parties, intending to be legally bound hereby, have
caused this Agreement to be executed in duplicate by their duly authorized
representatives as of the Effective Date.

BXLS FAMILY INVESTMENT PARTNERSHIP V – ESC L.P.

By: BXLS V Side-by-Side GP L.L.C.
Its General Partner

By:    /s/ Robert Liptak_________________
            Name: Robert Liptak
            Title: Authorized Person

Signature Page To The Co-Development Agreement

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EXHIBIT LIST

Exhibit A        [***]
Exhibit B        [***]
Exhibit C        [***]
Exhibit D        [***]
Exhibit E        Form of IP Security Agreement
[***]            [***]
ACTIVE/105695664.2

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Exhibit A
[***]

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Exhibit B
[***]

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Exhibit C
[***]

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Exhibit D
[***]

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Exhibit E
Form of IP Security Agreement