EXHIBIT 10.2

Execution Copy

 

 

EXCLUSIVE LICENSE AGREEMENT

 

 

By and between

ALNYLAM PHARMACEUTICALS, INC.

and

GENZYME CORPORATION

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

1

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

Exclusive License Agreement

 

TABLE OF CONTENTS

Page

1.

DEFINITIONS2

 

 

1.1

Incorporation by Reference of the Master Agreement.2

 

 

1.2

Definitions.2

 

2.

TRANSITION AND DEVELOPMENT11

 

 

2.1

Overview.11

 

 

2.2

Transition.11

 

 

2.3

Global TTR Development Plan.13

 

 

2.4

Diligence.13

 

 

2.5

Records; Reports; Information Sharing.13

 

 

2.6

Third Parties.14

 

3.

REGULATORY MATTERS15

 

 

3.1

Regulatory Filings and Interactions.15

 

 

3.2

Costs of Regulatory Affairs.16

 

 

3.3

Right of Reference.16

 

4.

COMMERCIALIZATION OF THE LICENSED PRODUCTS16

 

 

4.1

Responsibility, Cost and Diligence.16

 

 

4.2

Commercialization Summary16

 

 

4.3

First Commercial Sale Reporting Obligations.17

 

 

4.4

Advertising and Promotional Materials.17

 

 

4.5

Sales and Distribution.17

 

 

4.6

Recalls, Market Withdrawals or Corrective Actions.17

 

5.

TRANSITION MANAGEMENT17

 

 

5.1

Joint Transition Team.17

 

 

5.2

Meetings.18

 

 

5.3

Minutes.18

 

 

5.4

JTT Responsibilities.18

 

 

5.5

Decision-Making.19

 

 

5.6

Term of JTT.19

 

6.

MANUFACTURE AND SUPPLY OF THE LICENSED PRODUCTS19

 

 

6.1

Manufacturing and Supply.19

 

7.

LICENSES19

 

 

7.1

License Grants to Alnylam.19

 

 

7.2

Joint Collaboration IP.20

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

i

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

Exclusive License Agreement

 

 

7.3

Covenant not to Sue.21

 

 

7.4

Right of First Negotiation.21

 

 

7.5

Bankruptcy.21

 

 

7.6

No Other Rights.22

 

8.

CERTAIN FINANCIAL TERMS22

 

 

8.1

Royalties.22

 

 

8.2

Royalty Term.24

 

 

8.3

Royalty Adjustments.25

 

 

8.4

Reports; Payment of Royalty.26

 

 

8.5

Audits.26

 

 

8.6

Incorporation by Reference of Master Agreement Provisions.28

 

9.

CONFIDENTIALITY AND PUBLICATION28

 

 

9.1

Nondisclosure Obligation.28

 

 

9.2

Publication and Publicity.28

 

 

9.3

Press Release.28

 

 

9.4

Exclusivity.29

 

10.

REPRESENTATIONS, WARRANTIES AND COVENANTS29

 

 

10.1

Representations and Warranties of Genzyme.29

 

 

10.2

Warranty Disclaimer.30

 

 

10.3

Certain Covenants.31

 

11.

INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE31

 

 

11.1

General Indemnification by Genzyme.31

 

 

11.2

General Indemnification by Alnylam.31

 

 

11.3

Product Liability.32

 

 

11.4

Indemnification Procedure.32

 

 

11.5

Limitation of Liability.32

 

 

11.6

Insurance.33

 

12.

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS33

 

 

12.1

Inventorship.33

 

 

12.2

Ownership.33

 

 

12.3

Prosecution and Maintenance of Patent Rights.33

 

 

12.4

Third Party Infringement.34

 

 

12.5

Patent Term Extensions.35

 

 

12.6

Common Interest.35

 

 

12.7

Trademarks.35

 

 

12.8

Information Exchange during Defense in Patent Litigation.36

 

 

12.9

Cooperative Research and Technology (CREATE) Act Acknowledgment.36

 

 

12.10

Requirements for TTR In-Licenses.36

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

ii

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

Exclusive License Agreement

 

13.

TERM AND TERMINATION37

 

 

13.1

Term.37

 

 

13.2

Termination Rights.37

 

 

13.3

Effect of Termination.39

 

 

13.4

Effect of Expiration or Termination; Survival.40

 

14.

PERFORMANCE BY AFFILIATES40

 

 

14.1

Use of Affiliates.40

 

 

14.2

Acquired Programs.40

 

15.

MISCELLANEOUS41

 

 

15.1

Incorporation by Reference of Master Agreement Provisions.41

 

 

15.2

Entire Agreement; Amendments.41

 

 

15.3

Binding Effect; No Third Party Beneficiaries.41

 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

iii

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

Exclusive License Agreement

 

 

EXHIBIT

 

Exhibit AHigh Level Transition Outline

 

SCHEDULES

Schedule 1.2.12ALN-TTRsc02

Schedule 1.2.51Genzyme Patent Rights

Schedule 1.2.64Joint Collaboration Patent Rights

Schedule 10.1Disclosure Schedule

Schedule 10.1.8Genzyme In-Licenses

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

iv

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

Exclusive License Agreement

 

 

EXCLUSIVE LICENSE AGREEMENT

THIS EXCLUSIVE LICENSE AGREEMENT (this “Agreement”), is entered into as of
January 6, 2018 (the “Execution Date”), is entered into by and between Alnylam
Pharmaceuticals, Inc., a corporation organized and existing under the laws of
the State of Delaware (“Alnylam”), and Genzyme Corporation, a corporation
organized and existing under the laws of the Commonwealth of Massachusetts
(“Genzyme”). Except where otherwise specifically provided herein, the rights and
obligations set forth herein shall only become binding upon the Effective Date
(which, when used in this Agreement, has the meaning provided in Amendment No. 2
(as defined herein)).

RECITALS:

WHEREAS, Genzyme and Alnylam are parties to that certain Master Collaboration
Agreement dated as of January 11, 2014 (the “Original Collaboration Agreement”),
as amended by Amendment No. 1 to the Master Collaboration Agreement dated July
1, 2015 (“Amendment No. 1”) (the Original Collaboration Agreement, together with
Amendment No. 1 and Amendment No. 2 (as defined below), the “Master Agreement”)
pursuant to which, among other things, Alnylam granted Genzyme the exclusive
right to Develop and Commercialize ALN-TTR02, ALN-TTRsc, ALN-TTRsc02 (as a
back-up to ALN-TTRsc), and ALN-AT3 on a regional basis outside the United
States, Canada, and western Europe and the further right to co-Develop and
co-Commercialize ALN-TTRsc, ALN-TTRsc02 (as a back-up to ALN-TTRsc) and ALN-AT3
with Alnylam in the United States, Canada, and western Europe, in each case on
the terms and conditions set forth in the Master Agreement and the License Terms
attached to the Master Agreement as Appendix A (Regional License Terms),
Appendix B (Global License Terms) and Appendix C (Co-Co License Terms) (the
Master Agreement, together with the License Terms attached thereto, the
“Collaboration Agreement”);

WHEREAS, Genzyme has invested substantial resources to acquire such rights and
in the Development of ALN-TTR02 and ALN-TTRsc and the Parties now desire to
amend the above described terms and conditions as set forth in the Master
Agreement;

WHEREAS, Genzyme and Alnylam, as of the Effective Date, are simultaneously
entering into that certain Amendment No. 2 to the Collaboration Agreement
(“Amendment No. 2”) pursuant to which the Parties: (i) terminate the
co-Development and co-Commercialization rights provided for in the Co-Co License
Terms (as defined in the Collaboration Agreement), (ii) cease further
Development and Commercialization of ALN-TTR02 under the Regional License Terms
and of ALN-TTRsc and ALN-TTRsc02 under the Co-Co License Terms, (iii) cease
further Development and Commercialization of ALN-AT3 under the Co-Co License
Terms and (iv) confirm the continued effectiveness of certain remaining Options
(as defined in the Collaboration Agreement) held by Genzyme;

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

1

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

WHEREAS, the Parties have agreed to revised terms and conditions pursuant to
which Genzyme will pursue the further Development and Commercialization of
ALN-AT3 and any Back-Up Products (as defined in the AT3 License Terms) as set
forth in that certain ALN-AT3 Global License Terms entered into by and between
the Parties as of the Effective Date (the “AT3 License Terms”); and

WHEREAS, Genzyme and Alnylam now wish for Alnylam to have the right to pursue
the further Development and Commercialization of ALN-TTR02, ALN-TTRsc and
ALN-TTRsc02 and any Back-Up Products (as defined herein) in accordance with the
terms and conditions set forth herein.  

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties hereby agree as follows:

1.

DEFINITIONS

1.1Incorporation by Reference of the Master Agreement.  Certain Sections of this
Agreement incorporate by reference into this Agreement certain Sections of the
Master Agreement, mutatis mutandis.  For clarity, (a) all references in such
incorporated Sections of the Master Agreement to the License Terms, the
Collaboration Agreement or the Master Agreement shall be read as references to
this Agreement, (b) all references to a Party’s Alliance Manager shall be read
as references to such Party, and (c) any other terms defined in the Master
Agreement and used in such incorporated Sections of the Master Agreement shall
have the meaning set forth in this Agreement or, if not relevant to the rights
and obligations established herein (for example, because such defined terms
pertain solely to targets other than TTR), shall be disregarded.

1.2Definitions.  Unless specifically set forth to the contrary herein, the
following terms, whether used in the singular or plural, shall have the
respective meanings set forth below:

1.2.1“Acquired Business” has the meaning set forth in Section 14.2.1 (Acquired
Programs).

1.2.2“Acquirer” means a Third Party that acquires a Party or its business.

1.2.3“Affiliate” means, with respect to a Person, any other Person which
controls, is controlled by, or is under common control with the applicable
Person. For purposes of this definition, “control” means: (a) in the case of
corporate entities, direct or indirect ownership of [***] percent ([***]%) of
the stock or shares entitled to vote for the election of directors, or otherwise
having the power to control or direct the affairs of such Person; and (b) in the
case of non-corporate entities, direct or indirect

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

2

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

ownership of [***] percent ([***]%) of the equity interest or the power to
direct the management and policies of such non-corporate entities.

1.2.4“AJSC” has the meaning set forth in the Master Agreement.

1.2.5“Alnylam Indemnitees” has the meaning set forth in Section 11.1 (General
Indemnification by Genzyme).

1.2.6“Alnylam Know-How” means Know-How Controlled by Alnylam during the Term
that is reasonably necessary or useful for Genzyme to Develop and/or
Commercialize Licensed Products in the Field in the Licensed Territory, other
than Alnylam’s interest in Know-How included in Joint Collaboration IP.

1.2.7“Alnylam Patent Rights” means Patent Rights Controlled by Alnylam during
the Term that are reasonably necessary or useful to Develop and/or Commercialize
Licensed Products.  

1.2.8“Alnylam Technology” means, collectively, Alnylam Know-How and Alnylam
Patent Rights.

1.2.9“Alnylam TTR In-License” means any in-license between Alnylam and a Third
Party that includes a license or similar rights to Patent Rights or Know-How
that is [***].

1.2.10“ALN-TTR02” has the meaning set forth in the Master Agreement.

1.2.11“ALN-TTRsc” has the meaning set forth in the first sentence of the
definition of such term in the Master Agreement.  

1.2.12“ALN-TTRsc02” means an siRNA Controlled by Alnylam, comprising the siRNA
(#AD[***]) conjugated to a Ga1NAc Conjugate, as further described on
Schedule 1.2.12.  

1.2.13“ANDA” means an Abbreviated New Drug Application (or any successor
application or procedure) as defined in regulations promulgated by the FDA under
the FDCA, which ANDA is filed with or intended to be filed with the FDA (and, as
applicable, any other analogous application filed with a Regulatory Authority in
any country other than the U.S. in the Licensed Territory) for Regulatory
Approval for marketing and selling a Licensed Product in the Licensed Territory.

1.2.14“AT3 License Terms” has the meaning set forth in the recitals hereto.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

3

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

1.2.15“Back-Up Product” means any product Controlled by Alnylam comprising a
siRNA that targets TTR and (a) has achieved [***]) by [***], or (b) for which
Alnylam has [***] by [***].

1.2.16“Bankrupt Party” has the meaning set forth in Section 7.5 (Bankruptcy).

1.2.17“Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31 of
each Calendar Year, provided that (a) the first Calendar Quarter of the Term
shall begin on the Effective Date and end on the first to occur of March 31,
June 30, September 30 or December 31 thereafter and the last Calendar Quarter of
the Term shall end on the last day of the Term and (b) the first Calendar
Quarter of a Royalty Term for a Licensed Product in a country shall begin on the
First Commercial Sale of such Licensed Product in such country and end on the
first to occur of March 31, June 30, September 30 or December 31 thereafter and
the last Calendar Quarter of a Royalty Term shall end on the last day of such
Royalty Term.

1.2.18“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 of the Term shall begin on the Effective Date and end on the first
December 31 thereafter and the last Calendar Year of the Term shall end on the
last day of the Term and (b) the first Calendar Year of a Royalty Term for the
Licensed Products in a country shall begin on the First Commercial Sale of the
Licensed Products in such country and end on the first December 31 thereafter
and the last Calendar Year of the Term shall end on the last day of such Royalty
Term.

1.2.19“Certification” has the meaning set forth in Section 2.2.4 (Certification;
Term of Transition Plan).

1.2.20“Clinical Study” has the meaning set forth in the Master Agreement.

1.2.21“Co-Co Territory” has the meaning set forth in the Co-Co License Terms.

1.2.22“Collaboration” means the Collaboration of the Parties with respect to the
Development of the Licensed Products under the Master Agreement and the License
Terms prior to the Effective Date.

1.2.23“Collaboration Products” has the meaning set forth in the Master
Agreement.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

4

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

1.2.24“Commercialization” or “Commercialize” has the meaning set forth in the
Master Agreement.

1.2.25“Commercialization Summary” has the meaning set forth in Section 4.2
(Commercialization Summary).

1.2.26“Commercially Reasonable Efforts” means [***].

1.2.27“Competing Program” has the meaning set forth in Section 14.2.1 (Acquired
Programs).

1.2.28“Competitive Infringement” has the meaning set forth in Section 12.4.1
(Notices).

1.2.29“Confidential Information” means any and all confidential or proprietary
information and data (including Alnylam Technology, Genzyme Technology and Joint
Collaboration IP) and all other scientific, pre-clinical, clinical, regulatory,
manufacturing, marketing, financial and commercial information or data, whether
communicated in writing or orally or by any other method, which is or has been
provided by one Party to the other Party in connection with this Agreement.  All
Joint Collaboration IP and the terms of this Agreement are the Confidential
Information of both Parties, subject to Section 9.1 (Nondisclosure Obligation).

1.2.30“Control”, “Controls” or “Controlled by” has the meaning set forth in the
Master Agreement.

1.2.31“Cover,” “Covering” or “Covers” has the meaning set forth in the Master
Agreement.

1.2.32“Development,” “Developing” or “Develop” has the meaning set forth in the
Master Agreement.

1.2.33“Diligent Efforts” means, [***].

1.2.34“Effective Date” has the meaning provided in the Amendment No. 2.

1.2.35“EMA” means the European Medicines Agency and any successor Governmental
Authority having substantially the same function.

1.2.36“EU” means the European Union, as its membership may be altered from time
to time, and any successor thereto.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

5

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

1.2.37 “Exclusivity Period” means, on a Licensed Product-by-Licensed Product and
country-by-country basis within the Licensed Territory, the period of time
commencing on the Effective Date and continuing until the first to occur of
[***].

1.2.38“Execution Activities” has the meaning set forth in Section 2.2.1 (Scope
of Transition Plan).

1.2.39“Existing Global Development Plan” means the Global Development Plan for
ALN-TTR02 established by the Parties as contemplated under the Regional License
Terms.

1.2.40“FDA” means the United States Food and Drug Administration and any
successor Governmental Authority having substantially the same function.

1.2.41“FDCA” means the United States Federal Food, Drug, and Cosmetic Act of
1938, as amended from time to time, and the regulations and guidelines
promulgated thereunder.

1.2.42“Field” means the treatment, diagnosis and/or prevention of all human
diseases.

1.2.43“Final Transition Deadline” has the meaning set forth in Section 2.2.4
(Certification; Term of Transition Plan).

1.2.44“First Commercial Sale” means, with respect to a country, the first sale
for end use or consumption of a Licensed Product in such country, except for
compassionate use or patient access programs, after all Regulatory Approvals
legally required for such sale have been granted by the Regulatory Authority of
such country.

1.2.45“Former Genzyme Territory” means [***].

1.2.46“Generic Competition” means, with respect to the Licensed Products in any
country in the Licensed Territory in a given Calendar Quarter, that, during such
Calendar Quarter, (a) one or more Generic Products with respect to the Licensed
Products are commercially available in such country, and (b) Net Sales of the
Licensed Products in such country in such Calendar Quarter equal less than [***]
of the average Net Sales of the Licensed Products over the [***] consecutive
Calendar Quarters immediately prior to the Calendar Quarter in which one or more
Generic Products first became commercially available in such country.

1.2.47“Generic Product” means, on a Licensed Product-by-Licensed Product and
country-by-country basis, a pharmaceutical product that (a) is sold by a Person
that is not a Related Party of Alnylam under a marketing authorization granted
by a Regulatory Authority in such country to a Third Party; (b) [***]; and (c)
is approved by

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

6

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

the Regulatory Authority in such country pursuant to an approval process that
relies in part on pivotal safety and/or efficacy data in such Regulatory
Authority’s previous grant of marketing authorization for such Licensed Product.

1.2.48“Genzyme In-License” means any in-license between Genzyme and any Third
Party that includes a license or similar rights to Patent Rights or Know-How
that is necessary or useful for Alnylam to Develop and/or Commercialize the
Licensed Products in the Field.

1.2.49“Genzyme Indemnitees” has the meaning set forth in Section 11.2 (General
Indemnification by Alnylam).

1.2.50“Genzyme Know-How” means Know-How, first identified, discovered or
developed solely by employees of Genzyme or its Affiliates or other persons not
employed by Alnylam acting on behalf of Genzyme, in the conduct of the
Collaboration and, for clarity, before the Effective Date, that is Controlled by
Genzyme during the Term that is reasonably necessary or useful for Alnylam to
Develop and/or Commercialize (but not Manufacture) Licensed Products in the
Field in the Licensed Territory (other than Genzyme’s rights in Joint
Collaboration IP).

1.2.51“Genzyme Patent Rights” means (a) the Patent Rights that Cover the Genzyme
Know-How and that are listed on Schedule 1.2.51 and (b) any Patent Rights added
to Schedule 1.2.51.  Genzyme Patent Rights excludes Patent Rights included in
Genzyme’s interest in Joint Collaboration IP.

1.2.52“Genzyme Product-Specific Patent Rights” means Patent Rights Controlled by
Genzyme during the Term that Cover the Development or Commercialization of
ALN-TTR02 or ALN-TTRsc02, as such Licensed Products are formulated as of the
Effective Date.

1.2.53“Genzyme Technology” means, collectively, Genzyme Know-How, Genzyme Patent
Rights, and Genzyme’s interest in Joint Collaboration IP.

1.2.54“Genzyme Trademark” has the meaning set forth in Section 12.7(a)
(Trademarks).

1.2.55“Global Branding Strategy” has the meaning set forth in Section 4.4.1
(Global Branding).

1.2.56“Global AT3 Licensed Product” has the meaning set forth in the AT3 License
Terms.

1.2.57“Global TTR Development Plan” has the meaning set forth in Section 2.3
(Global TTR Development Plan).

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

7

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

1.2.58“GLP” or “Good Laboratory Practices” has the meaning set forth in the
Master Agreement.

1.2.59“Governmental Authority” means any applicable government authority, court,
tribunal, arbitrator, agency, department, legislative body, commission or other
instrumentality of (a) any government of any country or territory, (b) any
nation, state, province, county, city or other political subdivision thereof or
(c) any supranational body.

1.2.60“IND” has the meaning set forth in the Master Agreement.

1.2.61“Indemnitee” has the meaning set forth in Section 11.4 (Indemnification
Procedure).

1.2.62“Infringement Action” has the meaning set forth in Section 12.4.2 (Rights
to Enforce).

1.2.63“Initial Transition Deadline” has the meaning set forth in Section 2.2.4
(Certification; Term of Transition Plan).

1.2.64“Joint Collaboration IP” means, collectively, (a) any Know-How first
identified, discovered or developed jointly by employee(s), agent(s) or
consultant(s) acting on behalf of Alnylam or its Affiliates, on the one hand,
and employee(s), agent(s) or consultant(s) acting on behalf of Genzyme or its
Affiliates, on the other hand, in the conduct of the Collaboration that is
Controlled by Alnylam and Genzyme, and (b) any of the Patent Rights listed on
Schedule 1.2.64.  

1.2.65“Joint Transition Team” or “JTT” means the transition team as more fully
described in Section 5.1 (Joint Transition Team).

1.2.66“Know-How” has the meaning set forth in the Master Agreement.

1.2.67“Knowledge” means, with respect to any factual matters, the actual
knowledge of the members of Genzyme’s representatives to the JTT and the
knowledge that each such person would have, after reasonable investigation as to
such matters, including making due inquiries of Genzyme personnel that are
reasonably likely to have actual knowledge of such matters and responsibility
for such matters.

1.2.68“Laws” has the meaning set forth in the Master Agreement.

1.2.69“License Terms” has the meaning set forth in the Master Agreement.

1.2.70“Licensed Products” means and includes ALN-TTR02, ALN-TTRsc, ALN-TTR02sc
and any Back-Up Products, singly and collectively.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

8

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

1.2.71“Licensed Territory” means worldwide.

1.2.72“Losses” has the meaning set forth in Section 11.1 (General
Indemnification by Genzyme).

1.2.73“Manufacturing” or “Manufacture” means, as applicable, all activities
associated with the production, manufacture, process of formulating, processing,
filling, finishing, packaging, labeling, shipping, importing and storage of a
Licensed Product including process development, process validation, stability
testing, manufacturing scale-up, pre-clinical, clinical and commercial
manufacture and analytical development, product characterization, quality
assurance and quality control development, testing and release.

1.2.74“Manufacturing Claim” means a claim within a Patent Right directed solely
to Manufacturing a Licensed Product.

1.2.75“MMC” means the [***].

1.2.76“NDA” has the meaning set forth in the Master Agreement.

1.2.77“Net Sales” means [***].

1.2.78 “Non-Bankrupt Party” has the meaning set forth in Section 7.5
(Bankruptcy).

1.2.79“Party” means Genzyme and/or Alnylam.

1.2.80“Patent Challenge” has the meaning set forth in Section 13.2.3 (Challenge
of Patent Rights).

1.2.81“Patent Rights” has the meaning set forth in the Master Agreement.

1.2.82“Person” means any natural person, corporation, unincorporated
organization, partnership, association, sole proprietorship joint stock company,
joint venture, limited liability company, trust or government, or any
Governmental Authority, or any other similar entity.

1.2.83“Phase I Study” has the meaning set forth in the Master Agreement.

1.2.84“Phase II Study” has the meaning set forth in the Master Agreement.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

9

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

1.2.85“Phase III Study” has the meaning set forth in the Master Agreement.

1.2.86“Promotional Materials” has the meaning set forth in Section 4.4.2
(Promotional Materials).

1.2.87“Product Trademark(s)” means the Trademarks used, or intended for use, in
connection with the distribution, marketing, promotion and sale of the Licensed
Products.  Product Trademarks specifically exclude the corporate names and logos
of the Parties and their Affiliates.  Product Trademark includes both the
Alnylam Trademarks and the Genzyme Trademarks.

1.2.88“Proposed In-License Notice” has the meaning set forth in Section 12.10.1
(Requirements for TTR In-Licenses).

1.2.89“Regional License Terms” has the meaning set forth in the Master
Agreement.

1.2.90“Regulatory Approval” has the meaning set forth in the Master Agreement.

1.2.91“Regulatory Authority” has the meaning set forth in the Master Agreement.

1.2.92“Regulatory Exclusivity” means, with respect to a Licensed Product in a
country, any exclusive marketing right, data exclusivity right, orphan drug
designation or other country-wide exclusive right or status conferred by any
Governmental Authority with respect to such Licensed Product in such country,
other than a Patent Right, that limits or prohibits a Person [***].

1.2.93“Related Party” means a Party’s Affiliates and permitted Sublicensees.

1.2.94“Royalty Term” has the meaning set forth in Section 8.2 (Royalty Term).

1.2.95“Serious Adverse Event” has the meaning set forth in the Master Agreement.

1.2.96“siRNA” has the meaning set forth in the Master Agreement.

1.2.97“SPCs” has the meaning set forth in Section 12.5 (Patent Term Extensions).

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

10

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

1.2.98“Sublicensee” means a Third Party to whom Alnylam grants a sublicense
under any Alnylam Technology or Genzyme Technology to Develop or Commercialize
Licensed Products.

1.2.99“Term” has the meaning set forth in Section 13.1 (Term).

1.2.100“Third Party” has the meaning set forth in the Master Agreement.

1.2.101“Third Party In-License” means a Genzyme In-License or an Alnylam TTR
In-License.

1.2.102“Trademark” has the meaning set forth in the Master Agreement.

1.2.103“Transfer Activities” has the meaning set forth in Section 2.2.1 (Scope
of Transition Plan).

1.2.104“Transferred Information” has the meaning set forth in Section 2.2.1
(Scope of Transition Plan).

1.2.105“Transition Activities” has the meaning set forth in Section 2.2.1 (Scope
of Transition Plan).

1.2.106“Transition Period” means the period beginning on the Effective Date and
ending on the date that is the later of the Initial Transition Deadline and, if
applicable, the Final Transition Deadline.

1.2.107“Transition Plan” has the meaning set forth in Section 2.2.1 (Scope of
Transition Plan).

1.2.108“TTR” has the meaning set forth in the Master Agreement.

1.2.109“TTR In-License” has the meaning set forth in Section 12.10.1
(Requirements for TTR In-Licenses).

1.2.110“TTR Personnel” has the meaning set forth in Section 2.5.4 (Personnel).

1.2.111“Un-Blocking TTR In-License” means (i) an Alnylam TTR In-License or (ii)
a Genzyme In-License that in either case (clause (i) or (ii)) includes Patent
Rights that Cover a Licensed Product.

1.2.112“Uncompleted Transition Activities” has the meaning set forth in
Section 2.2.4 (Certification; Term of Transition Plan).

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

11

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

1.2.113“United States” or “U.S.” means the United States of America and its
territories, possessions and commonwealths.

1.2.114“Valid Claim” means a claim of: (a) an issued and unexpired patent, which
claim has not been withdrawn, cancelled, abandoned, disclaimed, revoked or held
unenforceable or invalid by an unappealable decision of a court or other
governmental agency of competent jurisdiction, or has not been appealed within
the time allowed for appeal, or by an appealed decision of a court or other
governmental agency of competent jurisdiction where the appeal has been pending
for more than [***] years (unless and until such decision is subsequently
overturned on appeal) and which has not been abandoned, disclaimed, denied or
admitted to be invalid or unenforceable through reissue, re-examination or
disclaimer or otherwise; or (b) a patent application that has been pending less
than [***] years from the date of filing of the earliest patent application from
which such patent application claims priority, which claim has not been
cancelled, withdrawn or abandoned or finally rejected by an administrative
agency action from which no appeal can be taken.

2.TRANSITION AND DEVELOPMENT

2.1Overview.  Alnylam will have the sole right to Develop the Licensed Products
in the Licensed Territory.  

2.2Transition.  

2.2.1Scope of Transition Plan.  Within [***] days after the Execution Date, the
Parties shall prepare and deliver to the JTT a draft plan for the transition of
the Development and Commercialization of the Licensed Products from Genzyme to
Alnylam (a “Transition Plan”), a high-level outline of which is attached hereto
as Exhibit A. Promptly following the delivery of such draft Transition Plan to
the JTT (and in any event no later than [***] days following such delivery), the
JTT shall finalize the Transition Plan and such Transition Plan shall be
incorporated by reference into this Agreement and shall replace Exhibit A
hereto.  The Transition Plan will require Genzyme to, as soon as reasonably
practicable following the Effective Date: [***]  (the items described in
connection therewith in clauses (a) through (e) collectively, “Transferred
Information,” and the activities described in connection therewith are the
“Transfer Activities”).  The Transition Plan for the Licensed Products will also
describe any Development activities with respect to the Licensed Products that
Genzyme is required to perform as requested by Alnylam and mutually agreed upon
by the Parties (“Execution Activities,” and together with the Transfer
Activities, the “Transition Activities”), as further described in Section 2.2.3
(Support of Global Development).  [***]  With respect to Genzyme employees
having experience or expertise relevant to the Development or Commercialization
of the Licensed Products as conducted prior to the Effective Date, Genzyme shall
(i) commit a

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

12

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

sufficient portion of such employee’s working hours to enable the completion of
the activities set forth in the Transition Plan for the Licensed Products in
accordance with the timeline set forth in such Transition Plan and (ii) make
such employees available to Alnylam at Alnylam’s reasonable request until the
obligations in such Transition Plan with respect to which such employee has
responsibilities are completed.

2.2.2Extension to Term of Transition Plan.  The Parties anticipate that the
Transition Plan will cover a [***]-month period from the Execution Date,
acknowledging that no Transfer Activities may be initiated prior to the
Effective Date.  In the event that Genzyme cannot deliver the Certification
described in Section 2.2.4 (Certification; Term of Transition Plan) below within
the aforementioned [***]-month period, then Genzyme shall have the right to
request an extension to the term of the Transition Plan in accordance with
Section 2.2.4 (Certification; Term of Transition Plan).

2.2.3Support of Global Development.  [***].  Unless otherwise agreed by the
Parties, the Execution Activities will include the obligations under the
Existing Global Development Plan approved by the Parties for use in connection
with the Licensed Product under the Collaboration Agreement, as such plans were
in effect immediately prior to the Effective Date, for the portion of such plans
as are within the Transition Period.

2.2.4Certification; Term of Transition Plan.  Genzyme shall notify Alnylam when
Genzyme can certify, in good faith and to the best of its Knowledge, that (a)
the Transfer Activities described in Sections 2.2.1(b), (c), and (d) have been
completed, (b) the Transfer Activities described in Sections 2.2.1(a) and (e)
have been substantially completed, (c) the Execution Activities to be performed
by Genzyme have been substantially completed and, (d) with respect to any
Transition Activity that has not been completed in full of which Genzyme has
Knowledge (the “Uncompleted Transition Activities”), (i) the identity of any
such Uncompleted Transition Activity has been included as an attachment to such
certification and (ii) such failure to have completed such Transition Activity
in full either (Y) arose out of circumstances that are beyond the reasonable
control of Genzyme despite the use of Diligent Efforts by Genzyme (including for
example, a failure of Alnylam to use Diligent Efforts in connection with the
Transition Activities) or (Z) would not reasonably be expected to have a
material adverse effect on the Development or Commercialization of the Licensed
Product in the Licensed Territory or in any country of a MMC (the
“Certification”).  If Genzyme does not provide such Certification on or before
the date that is [***] months after the Effective Date (the “Initial Transition
Deadline”) or identifies any Uncompleted Transition Activities in its
Certification as of the Initial Transition Deadline, then Genzyme shall have the
right to request an extension to the Initial Transition Deadline, and the JTT
shall amend the Transition Plan and

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

13

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

shall make any changes or adjustments reasonably necessary to address specific
root causes of delay and to expedite completion of the Transition Activities by
no later than the date that is [***] months from the Initial Transition Deadline
(such date, the “Final Transition Deadline”). By no later than the Final
Transition Deadline, Genzyme shall deliver the Certification (or, if such
Certification was previously delivered by the Initial Transition Deadline, an
updated Certification with respect to any Uncompleted Transition Activities), to
Alnylam.  In the event that Genzyme fails to complete any Transition Activities
assigned to it under the Transition Plan by the Final Transition Deadline
(including any Uncompleted Transition Activities), and such failure (Y) arose
out of circumstances that, through the use of Diligent Efforts by Genzyme, were
not or would not have been beyond the reasonable control of Genzyme and (Z)
would reasonably be expected to have a material adverse effect on the
Development or Commercialization of the Licensed Product in the Licensed
Territory or in any country of a MMC, then Genzyme shall [***] to complete such
Transition Activities as soon as reasonably practicable after the end of the
Transition Period until the first to occur of (1) such Transition Activities are
completed and (2) Alnylam agrees to the termination of such efforts by Genzyme.

2.2.5Costs during and after Transition Plan.  Each Party shall bear its own
costs (including any Third Party costs it incurs) in performing the Transfer
Activities.  Alnylam shall bear all costs (including any Third Party costs
incurred by Genzyme) associated with Genzyme performing the Execution Activities
assigned to it under the Transition Plan.

2.3Global TTR Development Plan.   Within [***] days following the Effective
Date, Alnylam shall provide the AJSC with a high-level summary plan for the
Development activities to be undertaken with respect to the Licensed Products in
the Licensed Territory (a “Global TTR Development Plan”).  During the Term,
Alnylam shall update the Global TTR Development Plan annually and shall provide
such updated Global TTR Development Plan to the AJSC.  The AJSC shall review and
comment on each Global TTR Development Plan submitted to it by Alnylam and
Alnylam shall consider the AJSC’s comments; provided, however, that Alnylam will
have sole discretion and control over the contents of such Global TTR
Development Plan.  

2.4Diligence.  Alnylam will use Commercially Reasonable Efforts to [***].

2.5Records; Reports; Information Sharing.  

2.5.1Development Activities.  [***], Alnylam will provide to Genzyme an update
regarding Development activities conducted by or on behalf of Alnylam with
respect to each Licensed Product, as well as any Clinical Studies with respect
to each Licensed Product conducted by Alnylam.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

14

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

2.5.2Scientific Records.  Alnylam will maintain scientific records, in
sufficient detail and in sound scientific manner appropriate for patent and
regulatory purposes and in compliance with Good Laboratory Practices with
respect to activities intended to be submitted in regulatory filings (including
INDs and NDAs), which will fully and properly reflect all work done and results
achieved in the performance of the Development activities and Clinical Studies
with respect to the Licensed Products.

2.5.3Information Exchange and Development Assistance.  Following the completion
of the Transition Plan with respect to the Licensed Products, Genzyme shall
deliver to Alnylam, [***] and in a commercially reasonable format, any
Transferred Information with respect to the Licensed Products that comes into
Genzyme’s Control or possession.  If Genzyme discovers that it Controls or
possesses any Transferred Information with respect to the Licensed Products that
should have been transferred by Genzyme to Alnylam under the Transition Plan but
that was not so transferred, Genzyme will promptly provide such Transferred
Information to Alnylam.

2.5.4Personnel.  Alnylam may request that Genzyme reasonably make available for
consultation regarding the Development and Commercialization of the Licensed
Products certain of its employees engaged in Development and Commercialization
activities with respect to the Licensed Products.  [***].  During the Transition
Period, the Parties shall work together in good faith to prepare and approve a
Transition Plan that [***].

2.5.5Confidentiality.  All information exchanged by the Parties under this
Section 2 will be deemed to be Confidential Information of the disclosing Party
and maintained in accordance with Section 9 (Confidentiality and Publication);
provided, however, that all Transferred Information with respect to the Licensed
Products delivered by Genzyme to Alnylam pursuant to Section 2.2 (Transition) or
2.5.3 (Information Exchange and Development Assistance) shall be deemed to be
Confidential Information of Alnylam.

2.6Third Parties. The Parties shall be entitled to utilize the services of Third
Parties to perform their respective Development and Manufacturing activities
hereunder, provided that (a) each Party shall require that such Third Party
operates in a manner consistent with the terms of this Agreement and (b) each
Party shall remain at all times fully liable for its respective
responsibilities. Each Party shall require that any such Third Party agreement
include confidentiality and non-use provisions that are no less stringent than
those set forth in Section 9 (Confidentiality and Publication) and shall obtain
ownership of, and/or a fully sublicensable license under and to, any Know-How
and Patent Rights that are developed by such Third Party in the performance of
such agreement and are reasonably necessary or useful to Develop, Manufacture
and/or Commercialize Licensed Products in the Field.  The Party utilizing the
services of a Third

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

15

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

Party service provider shall be solely responsible for direction of and
communications with such Third Party.

3.

REGULATORY MATTERS

3.1Regulatory Filings and Interactions.  

3.1.1Ownership of Regulatory Filings.  Alnylam will own all INDs, NDAs and
related regulatory documentation submitted to any Regulatory Authority in the
Licensed Territory with respect to the Licensed Products, excluding any drug
master files maintained by or on behalf of Genzyme.  At Alnylam’s request
following the Effective Date for a Licensed Product, Genzyme will promptly
assign and transfer to Alnylam all INDs, NDAs and other regulatory documentation
submitted to any Regulatory Authority in the Licensed Territory with respect to
such Licensed Product that is in the possession or control of Genzyme, excluding
any drug master files maintained by or on behalf of Genzyme, and each Party will
submit all filings, letters and other documentation necessary to effect such
assignment and transfer to the applicable Regulatory Authority no later than
[***] days after such request for such Licensed Product.  Genzyme hereby
appoints Alnylam as Genzyme’s agent for all matters related to each Licensed
Product involving Regulatory Authorities in the Licensed Territory during the
period beginning on the Effective Date and ending on the date that the transfer
of all INDs, NDAs and related regulatory documents filed with or submitted to
any Regulatory Authority in the Licensed Territory that relate to such Licensed
Product, excluding any drug master files maintained by or on behalf of Genzyme,
becomes effective, and Alnylam hereby accepts such appointment.  

3.1.2Responsibilities for Regulatory Matters.  Alnylam will be solely
responsible for all regulatory matters relating to the Licensed Products in the
Licensed Territory, including (i) overseeing, monitoring and coordinating all
regulatory actions, communications and filings with, and submissions to, each
Regulatory Authority in the Licensed Territory with respect to the Licensed
Products; (ii) interfacing, corresponding and meeting with each Regulatory
Authority in the Licensed Territory with respect to the Licensed Products; and
(iii) seeking and maintaining all regulatory filings in the Licensed Territory
with respect to the Licensed Products.

3.1.3Communications with Regulatory Authorities.  Alnylam will provide Genzyme,
through the AJSC, as part of the quarterly updates regarding Development
activities described in Section 2.5.1 (Development Activities), with a brief
description in English, of the principal issues raised in any material
communication with any Regulatory Authority in the Licensed Territory with
respect to any Licensed Product during the preceding Calendar Quarter.  For

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

16

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

purposes of this Section 3.1.3, “material communication” with Regulatory
Authorities include meetings with Regulatory Authorities and Regulatory
Authority questions or concerns regarding significant issues, including any of
the following: key product quality attributes (e.g., purity), safety findings
affecting the platform (e.g., Serious Adverse Events, emerging safety signals),
clinical or nonclinical findings affecting patient safety, or lack of efficacy.

3.1.4Submissions.  With respect to each Licensed Product, Alnylam shall provide
Genzyme with prompt written notice of each of the following events (but in any
event within [***] days) after the occurrence of such event in the Licensed
Territory: (i) the filing of any IND for the Licensed Products; (ii) the
submission of any filings or applications for Regulatory Approval (including
orphan drug applications and designations, investigators brochures, and label
updates) of the Licensed Products to any Regulatory Authority; and (iii) receipt
or denial of Regulatory Approval for the Licensed Products; provided, however,
that in all circumstances, Alnylam shall inform Genzyme of such event prior to
public disclosure of such event by Alnylam.  

3.2Costs of Regulatory Affairs.  After expiration of the Transition Period,
Alnylam shall be responsible for [***] in connection with applying for
Regulatory Approval with respect to Licensed Products in the Licensed Territory,
and related regulatory affairs activities.

3.3Right of Reference.   Genzyme hereby grants to Alnylam, and at the request of
Alnylam will grant to Alnylam’s Related Parties, a “Right of Reference,” as that
term is defined in 21 C.F.R. § 314.3(b) (or any successor rule or analogous Law
recognized outside of the United States), to, and a right to copy, access, and
otherwise use, all information and data (including all CMC information as well
as data made, collected or otherwise generated in the conduct of any preclinical
(including toxicology) studies, Clinical Studies or early access/named patient
programs for the Licensed Products) included in or used in support of a
regulatory filing, Regulatory Approval, drug master file or other regulatory
documentation (including orphan drug applications and designations) made or
maintained by or on behalf of Genzyme or its Related Parties to the extent
necessary or useful to Develop, Manufacture or Commercialize Licensed Products
in the Licensed Territory.  Notwithstanding anything to the contrary in this
Agreement, Genzyme shall not withdraw or inactivate any regulatory filing that
Alnylam or an Alnylam Related Party references or otherwise uses pursuant to
this Section 3.3.

4.

COMMERCIALIZATION OF THE LICENSED PRODUCTS

4.1Responsibility, Cost and Diligence.  After expiration of the Transition
Period, Alnylam shall be solely responsible, at its expense, for all
Commercialization activities relating to the Licensed Products in the Field in
the Licensed Territory.  Alnylam shall use Commercially Reasonable Efforts to
[***].

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

17

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

4.2Commercialization Summary.  No less than [***] months in advance of the
reasonably expected first Regulatory Approval in the Licensed Territory with
respect to the Licensed Products, and annually thereafter, Alnylam shall prepare
and deliver to the AJSC (i) a high level summary of the Commercialization and
Development activities performed in each MMC during the just-completed Calendar
Year and (ii) a high level summary of the Commercialization and Development
activities to be undertaken with respect to the Licensed Products in the
then-current Calendar Year and Alnylam’s plans to obtain further Regulatory
Approvals and Commercialize the Licensed Products in each MMC in which Alnylam
is not then Commercializing the Licensed Products, and the dates by which such
activities are targeted to be accomplished (the “Commercialization Summary”).

4.3First Commercial Sale Reporting Obligations.  Alnylam shall promptly provide
Genzyme with written notice of the First Commercial Sale of each of the Licensed
Products.

4.4Advertising and Promotional Materials.  

4.4.1Global Branding.  Alnylam shall have the sole right, from time to time
during the Term, to develop (and thereafter modify and update) a global branding
strategy (including global positioning, messages, logo, colors and other visual
branding elements) for the Licensed Products for use in the Field throughout the
Licensed Territory (the “Global Branding Strategy”) for review by the AJSC.  

4.4.2Promotional Materials.  Alnylam will be responsible for the creation,
preparation, production, reproduction and filing with the applicable Regulatory
Authorities, of relevant written sales, promotion and advertising materials
relating to the Licensed Products (“Promotional Materials”) for use in the
Licensed Territory. All such Promotional Materials will be compliant with
applicable Law.

4.5Sales and Distribution.   Alnylam and its Related Parties shall be solely
responsible for booking sales and for warehousing and distribution of the
Licensed Products in the Licensed Territory.

4.6Recalls, Market Withdrawals or Corrective Actions.  In the event that any
Regulatory Authority issues or requests a recall or takes a similar action in
connection with the Licensed Products, Alnylam shall have the sole right to
decide whether to conduct a recall and the manner in which any such recall shall
be conducted.  Alnylam shall [***] of any such recall.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

18

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

5.

TRANSITION MANAGEMENT  

5.1Joint Transition Team.  The Parties shall establish a JTT to facilitate the
transition of the Licensed Products from Genzyme to Alnylam as follows:

5.1.1Composition of the Joint Transition Team.  The transition of each Licensed
Product from Genzyme to Alnylam shall be conducted under the oversight of a JTT,
which shall comprise three (3) representatives of each Party.  Each Party shall
appoint its respective representatives to the JTT for the Licensed Products
within [***] days following the Effective Date, and may substitute one or more
of its representatives, in its sole discretion, effective upon notice to the
other Party of such change. Each representative on a JTT shall have appropriate
expertise and ongoing familiarity with the Licensed Products.  Additional
representatives or consultants may from time to time, by mutual consent of the
Parties, be invited to attend JTT meetings, subject to such representatives and
consultants undertaking confidentiality obligations, whether in a written
agreement or by operation of law, no less stringent than the requirements of
Section 9 (Confidentiality and Publication).

5.1.2JTT Chairperson.  The JTT chairperson shall be a JTT representative of
Alnylam.  The JTT chairperson’s responsibilities shall include (a) scheduling
meetings; (b) setting agendas for meetings with solicited input from other
members; (c) coordinating the delivery of draft minutes to the JTT for review
and final approval; and (d) conducting meetings, including ensuring that
objectives for each meeting are set and achieved.

5.2Meetings.  The JTT shall meet in accordance with a schedule established by
mutual written agreement of the Parties, with the location for such meetings
alternating between Alnylam and Genzyme facilities (or such other locations as
are mutually agreed by the Parties).  Alternatively, a JTT may meet by means of
teleconference, videoconference or other similar communications equipment.  All
proceedings for the JTT shall take place in English. Where the membership of a
JTT for a Licensed Product is the same as one or more other JTTs for other
Licensed Products, such JTTs may have a single meeting to discuss each Licensed
Product for which they have responsibility.  Each Party shall bear its own
expenses relating to attendance at such meetings by its representatives.

5.3Minutes. A secretary shall be appointed for each meeting of each JTT and
shall prepare minutes of the meeting, which shall provide a description in
reasonable detail of the discussions held at the meeting and a list of any
actions, decisions or determinations approved by such JTT.

5.4JTT Responsibilities. The JTT shall have the following responsibilities with
respect to the Licensed Products:

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

19

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

(a)finalizing and approving a Transition Plan for the Licensed Products that
meets the requirements set forth in Section 2.2 (Transition), including any
Transition Activities that Genzyme will be obligated to perform under such
Transition Plan;

(b)reviewing and commenting on the initial Global TTR Development Plan for such
Licensed Product, and reviewing and commenting on updates to the Global TTR
Development Plans provided by Alnylam; and

(c)performing such other activities as the Parties agree in writing shall be the
responsibility of such JTT.

5.5Decision-Making.   The JTT shall not have any decision-making authority with
respect to any matters under this Agreement; provided, however, that the JTT
shall have the authority to approve the Transition Plan for the Licensed
Products.  With respect to approving the Transition Plan, the representatives of
each Party on a JTT shall have collectively one vote on behalf of such Party and
such JTT shall attempt to approve the Transition Plan by consensus.  If the JTT
fails to approve a Transition Plan for the Licensed Products within [***] days
after delivery of the Transition Plan to the JTT, then the matter shall be
submitted to the AJSC.  If the matter is still unresolved after a further [***]
days, then such matter shall be submitted to [***].

5.5.1[***]

(a)[***]

(b)[***]

(c)[***]

(d)[***]

(e)[***]

5.6Term of JTT. Upon expiration of the Transition Period, either Party shall
have the right to terminate the Parties’ respective obligations to participate
in the JTT for the Licensed Products.

6.

MANUFACTURE AND SUPPLY OF THE LICENSED PRODUCTS

6.1Manufacturing and Supply.    Alnylam shall be solely responsible, at its
expense, for all Manufacturing activities relating to the Licensed Products in
the Field in the Licensed Territory.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

20

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

7.

LICENSES

7.1License Grants to Alnylam.

7.1.1Development License.  On a Licensed Product-by-Licensed Product basis,
subject to the provisions of this Agreement, Genzyme hereby grants Alnylam a
non-transferable (except as provided in Section 15 (Miscellaneous)),
sublicensable (subject to Section 7.1.3 (Sublicensing Terms)), exclusive (even
as to Genzyme) license under the Genzyme Technology to Develop such Licensed
Product in the Field in the Licensed Territory.

7.1.2Commercialization License.  On a Licensed Product-by-Licensed Product
basis, subject to the provisions of this Agreement, Genzyme hereby grants
Alnylam a non-transferable (except as provided in Section 15 (Miscellaneous)),
sublicensable (subject to Section 7.1.3 (Sublicensing Terms)), exclusive (even
as to Genzyme) license under the Genzyme Technology to Commercialize such
Licensed Product in the Field in the Licensed Territory. Such license shall be
royalty-bearing for the Royalty Term applicable to such Licensed Product in each
country in the Licensed Territory, and, after the Royalty Term applicable to
such Licensed Product in such country, shall convert to a fully-paid, perpetual
license to Commercialize such Licensed Product in the Field in such country.

7.1.3Sublicensing Terms.

(a)Subject to Section 7.4 (Right of First Negotiation), Alnylam shall have the
right to sublicense any of its rights under Sections 7.1.1 (Development License)
and 7.1.2 (Commercialization License) to any of its Affiliates or to any Third
Party (which sublicensed rights may be further sublicensable through multiple
tiers) without the prior consent of Genzyme, subject to the requirements of this
Section 7.1.3.

(b)Each sublicense granted by Alnylam pursuant to this Section 7.1.3 shall be
subject, and subordinate, to the provisions of this Agreement and shall contain
provisions consistent with those in this Agreement. Alnylam shall promptly
provide Genzyme with a copy of the fully executed sublicense agreement covering
any sublicense granted under this Section 7.1.3 (which copy may be redacted to
remove provisions which are not necessary to monitor compliance with this
Section 7.1.3), and each such sublicense agreement shall contain the following
provisions: (i) a requirement that the Sublicensee comply with the
confidentiality and non-use provisions of Section 9 (Confidentiality and
Publication) with respect to Genzyme’s Confidential Information, (ii) if such
sublicense agreement contains a sublicense of Licensed Products
Commercialization rights, such sublicense agreement shall also contain the
following provisions: (x) a requirement that the Sublicensee submit applicable
sales or other reports to Alnylam to the extent necessary or relevant to the
reports required to be made or records required to be

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

21

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

maintained under this Agreement; (y) the audit requirement set forth in
Section 8.5 (Audits); and (z) a requirement that the Sublicensee comply with the
applicable provisions under any Genzyme In-License.

(c)If Alnylam becomes aware of a material breach of the terms of any sublicense
granted under this Section 7.1.3 by any Sublicensee, compliance with which is
necessary for Alnylam’s compliance with the terms of this Agreement, Alnylam
shall promptly notify Genzyme of the particulars of the same and use
Commercially Reasonable Efforts to cause the Sublicensee to comply with all the
terms of the sublicense necessary for Alnylam’s compliance with the terms of
this Agreement [***] Notwithstanding any sublicense, Alnylam shall remain
primarily liable to Genzyme for the performance of all of Alnylam’s obligations
under, and Alnylam’s compliance with all provisions of, this Agreement.

7.2Joint Collaboration IP.  Subject to the rights and licenses granted to, and
the obligations (including royalty obligations) of, each Party under this
Agreement and the Collaboration Agreement, each Party is entitled to practice
Joint Collaboration IP for all purposes on a worldwide basis and license Joint
Collaboration IP without consent of and without a duty of accounting to the
other Party. Each Party will grant and hereby does grant all permissions,
consents and waivers with respect to, and all licenses under, the Joint
Collaboration IP, throughout the world, necessary to provide the other Party
with such rights of use and exploitation of the Joint Collaboration IP, and will
execute documents as necessary to accomplish the foregoing.

7.3Covenant not to Sue.  During the Term, Genzyme covenants, for itself and its
Affiliates, not to either directly or indirectly make, file, bring or maintain
any claim, demand or lawsuit against Alnylam or its Related Parties, which
alleges infringement by Alnylam or its Related Parties of any Genzyme
Product-Specific Patent Rights due to any Development or Commercialization of a
Licensed Product.

7.4Right of First Negotiation.  If, at any time prior to the fifth anniversary
of the Effective Date, Alnylam desires to grant any Third Party rights to
Develop and/or Commercialize one or more Licensed Product(s) in the Field in any
portion of the Licensed Territory (excluding customary distribution arrangements
entered into in the ordinary course of business by Alnylam), Alnylam shall
notify Genzyme in writing of its intent. Genzyme shall have [***] days from
receipt of such written notice to notify Alnylam in writing as to whether
Genzyme desires to negotiate for such rights in such territory, and if Genzyme
so notifies Alnylam that it does desire to negotiate for such rights in such
territory, Genzyme shall have the exclusive right for [***] days from the date
of such notification to Alnylam to negotiate with Alnylam and to make one or
more written non-binding offers to Alnylam concerning the acquisition of such
rights in such territory by Genzyme.  Genzyme shall have the exclusive right for
[***] days (or such longer period as may be mutually agreed by the Parties)
after such [***] day period, to finalize and enter into a definitive agreement
with Alnylam for such rights in such

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

22

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

territory, provided that if either Genzyme does not provide such written notice
within such [***] day period or Genzyme does provide such written non-binding
offer within such subsequent [***] day period, or Genzyme provides such notice
of interest and such written offer but for any reason Genzyme and Alnylam do not
enter into a definitive agreement within the [***] day negotiation period,
Alnylam shall be free to enter into an agreement with a Third Party(ies)
relating to such rights in such territory, without further obligation to
Genzyme.  [***].  For clarity, prior to the exclusive negotiating periods
described above, Alnylam shall be free to engage in discussions and exchange
information with Third Parties with respect to the applicable Licensed
Product(s) rights, but shall not enter into any binding agreement with any Third
Party with respect to such rights.

7.5Bankruptcy.  All rights and licenses granted under or pursuant to this
Agreement by Genzyme to Alnylam, including those set forth in Section 7.1
(License Grants to Alnylam) are and shall otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to
“intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that Alnylam and its Sublicensees, as sublicensees of
such rights under this Agreement, shall retain and may fully exercise all of
their rights and elections under the U.S. Bankruptcy Code and any foreign
counterpart thereto. The Parties further agree that upon commencement of a
bankruptcy proceeding by or against Genzyme (the “Bankrupt Party”) under the
Bankruptcy Code, the other Party (the “Non-Bankrupt Party”) will be entitled to
a complete duplicate of, or complete access to (as the Non-Bankrupt Party deems
appropriate), all such intellectual property and all embodiments of such
intellectual property. Such intellectual property and all embodiments of such
intellectual property will be promptly delivered to the Non-Bankrupt Party (a)
upon any such commencement of a bankruptcy proceeding and upon written request
by the Non-Bankrupt Party, unless the Bankrupt Party elects to continue to
perform all of its obligations under this Agreement, or (b) if not delivered
under (a) above, upon the rejection of this Agreement by or on behalf of the
Bankrupt Party and upon written request by the Non-Bankrupt Party. Without
limiting the foregoing, Alnylam hereby grants to Genzyme a right of access to
and to obtain possession of (i) copies of research data, (ii) laboratory
samples, (iii) samples of Licensed Products, (iv) formulas, (v) laboratory notes
and notebooks, (vi) data and results related to clinical trials, (vii)
regulatory filings and approvals, (viii) rights of reference in respect of
regulatory filings and approvals, (ix) pre-clinical research data and results,
(x) marketing, advertising and promotional materials, all of which (in clauses
(i) through (x)) constitute “embodiments” of intellectual property pursuant to
Section 365(n) of the Bankruptcy Code and (xi) all other embodiments of such
intellectual property, and in respect of each of the foregoing clauses (i)
through (xi), solely for the purpose of the exercise of Alnylam’s rights and
licenses under this Agreement, whether any of the foregoing are in Genzyme’s
possession or control or in the possession and control of Third Parties. The
Bankrupt Party (in any capacity, including debtor-in-possession) and its
successors and assigns (including any trustee)

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

23

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

agrees not to interfere with the exercise by Non-Bankrupt Party or its Related
Parties of its rights and licenses to such intellectual property and such
embodiments of intellectual property in accordance with this Agreement, and
agrees to assist the Non-Bankrupt Party and its Related Parties in obtaining
such intellectual property and such embodiments of intellectual property in the
possession or control of Third Parties as reasonably necessary or desirable for
the Non-Bankrupt Party to exercise such rights and licenses in accordance with
this Agreement. The foregoing provisions are without prejudice to any rights the
Non-Bankrupt Party may have arising under the Bankruptcy Code or other Laws.

7.6No Other Rights.  Except as otherwise expressly provided in this Agreement,
under no circumstances shall a Party, as a result of this Agreement, obtain any
ownership interest or other right in any Know-How, Patent Rights or other
intellectual property rights of the other Party, including items owned,
controlled or developed by the other Party, or provided by the other Party to
the receiving Party at any time pursuant to this Agreement.

8.

CERTAIN FINANCIAL TERMS

8.1Royalties.  

8.1.1Royalty Rates.

8.1.1.1Royalties Payable on ALN-TTR02 in the Former Genzyme Territory Excluding
Japan.  Subject to the provisions of this Agreement, Alnylam shall pay to
Genzyme royalties on annual Net Sales of ALN-TTR02 by Alnylam and its Related
Parties in the Former Genzyme Territory, excluding Japan, as determined on a
country-by-country basis, as follows:

Period During Which Net Sales of ALN-TTR02 Accrued in the Former Genzyme
Territory Excluding Japan

Royalty
(as a percentage of Net Sales of
ALN-TTR02 in the Former Genzyme Territory Excluding Japan)

[***]

[***]

[***]

[***]

[***]

[***]

 

8.1.1.2Royalties Payable on ALN-TTR02 in Japan.  Subject to the provisions of
this Agreement, Alnylam shall pay to Genzyme royalties on annual Net Sales of
ALN-TTR02 by Alnylam and its Related Parties in Japan, as follows:

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

24

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

Period During Which Net Sales of ALN-TTR02 Accrued in Japan

Royalty
(as a percentage of Net Sales of ALN-TTR02 in Japan)

[***]

[***]

 

8.1.1.3Royalties Payable on ALN-TTRsc02.  Subject to the provisions of this
Agreement, Alnylam shall pay to Genzyme royalties on annual Net Sales of
ALN-TTRsc02 by Alnylam and its Related Parties in the Licensed Territory as
follows:

Calendar Year
Net Sales of ALN-TTRsc02
in the Licensed Territory

Royalty
(as a percentage of Net Sales of
ALN-TTRsc02)

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

Royalties on annual Net Sales of ALN-TTRsc02 shall be paid at the rate
applicable to the portion of such annual Net Sales within each of the Net Sales
levels above during such Calendar Year.  By way of example only, if Alnylam
receives [***] U.S. Dollars ($[***]) in Net Sales of ALN-TTRsc02 in the Licensed
Territory during a given Calendar Year, then the royalties payable by Alnylam
under this Section 8.1.1.3 on such Net Sales would be calculated as follows:

 

[***]

 

Royalties on annual Net Sales shall be paid at the rate applicable to the
portion of such Net Sales within each of the Net Sales levels above during such
Calendar Year.

8.1.1.4  Royalties Payable on Back-Up Products.  Subject to the terms of this
Agreement, Alnylam shall pay to Genzyme royalties on annual Net Sales of each
Back-Up Product by Alnylam and its Related Parties in the Licensed Territory, as
determined on a Back-Up Product-by-Back-Up Product basis, as follows:

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

25

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

Calendar Year
Net Sales of a Back-Up Product
in the Licensed Territory

Royalty
(as a percentage of Net Sales of
a Back-Up Product)

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

Royalties on annual Net Sales of Back-Up Products shall be paid at the rate
applicable to the portion of such annual Net Sales within each of the Net Sales
levels above during such Calendar Year, consistent with the exemplary
calculation set forth in Section 8.1.1.3.

8.2Royalty Term.  Subject to Section 8.3.4 (Royalty Floor), the period during
which the royalties set forth in Section 8.1.1 (Royalty Rates) shall be payable,
on a Licensed Product-by-Licensed Product and country-by-country basis, shall
commence with the First Commercial Sale of a Licensed Product in a country and
continue until the latest of (a) expiration of the last Valid Claim of (i) the
Alnylam Patent Rights, (ii) Genzyme Patent Rights, or (iii) any Patent Right
included in the Joint Collaboration IP, in each case (clauses (i) - (iii))
Covering the Manufacture, use, offer for sale, sale or importation of such
Licensed Product in the country of sale; (b) the expiration of Regulatory
Exclusivity for such Licensed Product in such country; or (c) subject to the
last sentence of this Section 8.2 (Royalty Term), the twelfth (12th) anniversary
of the First Commercial Sale of such Licensed Product in such country (each such
period, a “Royalty Term”). [***].

8.3Royalty Adjustments.  

8.3.1Third Party Royalty Offsets.  Alnylam shall be permitted to reduce any
royalties payable under Section 8.1.1 (Royalty Rates) for ALN-TTRsc02 and the
Back-Up Products by [***] percent ([***]) of any amounts for which Alnylam is
responsible under any Un-Blocking TTR In-License, other than amounts in respect
of any Un-Blocking TTR In-License identified on paragraphs 1, 2, 4, 6, and 7 of
Schedule 1.2.178 of the Master Agreement, but only to the extent that the
relevant payment under any such Un-Blocking TTR In-License constitutes either
royalties or a milestone payment based on sales of such Licensed Products;
provided, however, that the royalties payable under

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

26

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

Section 8.1.1 (Royalty Rates) with respect to the Licensed Products shall not be
reduced in any such event below [***]percent ([***]) of the amounts set forth in
Section 8.1.1 (Royalty Rates) and; provided, further, that if any of such
amounts cannot be offset against royalties due with respect to the Licensed
Products for any given royalty period due to the preceding proviso, such unused
amount may be carried forward and offset against royalties due with respect to
the Licensed Products in future royalty periods.

8.3.2No Patents or Regulatory Exclusivity.  The royalties to be paid by Alnylam
to Genzyme pursuant to Section 8.1.1 (Royalty Rates) with respect to any
Licensed Products shall be reduced to [***] percent ([***]) of the amounts
otherwise payable pursuant to Section 8.1.1 (Royalty Rates)  with respect to Net
Sales of the Licensed Products in a country of the Licensed Territory as to
which both (a) the Manufacture, use, offer for sale, sale or importation of
which is not Covered by any Valid Claim in any Alnylam Patent Right or in any
Patent Right included in the Joint Collaboration IP in such country and (b)
there is no applicable Regulatory Exclusivity in such country.

8.3.3Royalty Adjustments for Generic Products.  If, during a given Calendar
Quarter when the Licensed Products is being Commercialized by or on behalf of
Alnylam in a particular country in the Licensed Territory, there is Generic
Competition in such country with respect to the Licensed Products, then, subject
to Section 8.3.4 (Royalty Floor), the royalties payable pursuant to
Section 8.1.1 (Royalty Rates) on the Net Sales of the Licensed Products in such
country shall thereafter be reduced to [***] percent ([***]) of the amounts
otherwise payable pursuant to Section 8.1.1 (Royalty Rates) with respect to the
Licensed Products in such country for such Calendar Quarter for so long as such
Generic Competition remains.

8.3.4Royalty Floor.  Anything in this Agreement to the contrary notwithstanding,
in no event during the applicable Royalty Term for the Licensed Products in a
country of the Licensed Territory shall the royalties payable to Genzyme
hereunder for the Licensed Products in such country for any Calendar Quarter be
reduced (a) by the application of the reductions or credits described in
Sections 8.3.1 (Third Party Royalty Offsets) or 8.3.2 (No Patents or Regulatory
Exclusivity), whether taken together or separately, to less than [***] percent
([***]) of the royalties payable pursuant to Section 8.1.1 (Royalty Rates) as to
the Licensed Products in such country for such Calendar Quarter, or (b) by the
application of the reductions or credits described in Sections 8.3.1 (Third
Party Royalty Offsets), 8.3.2 (No Patents or Regulatory Exclusivity), 8.3.3
(Royalty Adjustments for Generic Products) and/or 12.4.2 (Rights to Enforce),
whether taken together or separately, to less than [***] percent ([***]) of the
royalties payable pursuant to Section 8.1.1 (Royalty Rates) as to the Licensed
Products in such country for such Calendar Quarter.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

27

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

8.3.5Validation Information.  At Genzyme’s request, Alnylam will provide Genzyme
with such information as Genzyme may reasonably request to validate the amount
of the royalty floor described in Section 8.3.4 (Royalty Floor).

8.3.6Reasonable Royalty.  The Parties hereby acknowledge that the royalties
payable hereunder by Alnylam to Genzyme are reasonable in light of Genzyme’s
investment in the Development of the Licensed Products, Genzyme’s agreement to
forego participation in the further Development and Commercialization of the
Licensed Products and the licenses and other rights granted hereunder by Genzyme
to Alnylam.

8.4Reports; Payment of Royalty.   During the Term, following the First
Commercial Sale of any Licensed Product by or on behalf of Alnylam, Alnylam
shall furnish to Genzyme a written report within [***] days after the end of
each Calendar Quarter showing, on a Licensed Product-by-Licensed Product and
country-by-country basis, the Net Sales of each Licensed Product, deductions
from gross sales (itemized by deduction category) included in the calculation of
Net Sales for each Licensed Product as a whole (or, if such information is not
available, then whatever then existing information is in Alnylam’s possession
detailing any such deductions), royalties and sales milestones payable under any
applicable Un-Blocking TTR In-License with respect to such Net Sales and the
royalties payable hereunder with respect to each such Licensed Product. Except
as expressly provided herein, all payments by one Party to the other Party under
this Agreement shall be non-refundable and non-creditable and not subject to
set-off.  Royalties shown to have accrued by each royalty report shall be due
and payable [***] days following the date such royalty report is due. In
addition, Alnylam shall prepare and deliver to Genzyme any additional reports
for sales of the Licensed Products as required under any applicable Genzyme
In-Licenses.

8.5Audits.  

8.5.1On a Licensed Product-by-Licensed Product basis, upon the written request
Genzyme and not more than [***] in each Calendar Year, Alnylam and its Related
Parties shall permit an independent certified public accounting firm of
internationally-recognized standing selected by Genzyme and reasonably
acceptable to Alnylam, at Genzyme’s expense except as set forth below, to have
access during normal business hours to such of the records of Alnylam as may be
reasonably necessary to verify the accuracy of the royalty and other amounts
payable or reports under this Agreement in respect of such Licensed Product for
any year ending not more than [***] years prior to the date of such request for
the sole purpose of verifying the basis and accuracy of payments made under this
Agreement in respect of such Licensed Product. Notwithstanding the foregoing,
Genzyme may not make more than [***] such

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

28

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

request in a Calendar Year, provided that a request may cover multiple Licensed
Products.

8.5.2If such accounting firm identifies a discrepancy made during such period,
the appropriate Party shall pay the other Party the amount of the discrepancy,
together with late-payment interest in accordance with Section 9.4 of the Master
Agreement (Late Payments), which is hereby incorporated by reference, within
[***] days after the date Genzyme delivers to Alnylam such accounting firm’s
written report so concluding, or as otherwise agreed by the Parties in writing.
The fees charged by such accounting firm shall be paid by Genzyme, unless such
discrepancy represents an underpayment by Alnylam of at least [***] percent
([***]), on a Licensed Product-by-Licensed Product basis, of the total amounts
due in respect of such Licensed Product in the audited period, in which case
such fees shall be paid by Alnylam.

8.5.3Alnylam shall comply with all applicable audit requirements in the
respective Third Party In-Licenses and shall include in each sublicense granted
by it pursuant to this Agreement a provision requiring any Sublicensee to make
reports to Alnylam, to keep and maintain records of sales made pursuant to such
sublicense and to grant access to such records by the independent accountant of
Alnylam to the same extent required of Alnylam under this Agreement.

8.5.4Unless an audit for such year has been commenced prior to and is ongoing
upon the [***] anniversary of the end of such year, the calculation of
royalties, expense reimbursement and other payments payable with respect to such
year shall be binding and conclusive upon both Parties, and each Party and its
Related Parties shall be released from any further liability or accountability
with respect to such royalties or expense reimbursement for such year.

8.5.5Each Party shall treat all financial information subject to review under
this Section 8.5 or under any sublicense agreement in accordance with the
confidentiality and non-use provisions of Section 9 (Confidentiality and
Publication), and shall cause its accounting firm to enter into a
confidentiality agreement with the other Party or its Related Parties obligating
it to retain all such information in confidence pursuant to such confidentiality
agreement, which terms shall be no less stringent than the provisions of Section
9 (Confidentiality and Publication).

8.6Incorporation by Reference of Master Agreement Provisions. Sections 9.3
through 9.6 of the Master Agreement are hereby incorporated by reference,
mutatis mutandis.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

29

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

9.

CONFIDENTIALITY AND PUBLICATION

9.1Nondisclosure Obligation.  

9.1.1All Confidential Information disclosed by one Party to the other Party
hereunder shall be maintained in confidence by the receiving Party and shall not
be disclosed to a Third Party or used for any purpose, except that the
non-disclosure exceptions set forth in Section 7.1.2 of the Master Agreement are
hereby incorporated by reference, mutatis mutandis.

9.2Publication and Publicity.  

9.2.1Publication.  Except for disclosures permitted pursuant to Section 9.1
(Nondisclosure Obligation) and 9.2.2 (Publicity), as between the Parties,
Alnylam shall have the sole right to publish or present publicly the results of
any Development or Commercialization of the Licensed Products.  

9.2.2Publicity. Except as set forth in Section 9.1 (Nondisclosure Obligation)
and Section 9.2.1 (Publication) above and 9.3.2 (Press Release) below, the terms
of this Agreement may not be disclosed by either Party, and neither Party shall
use the name, Trademark, trade name or logo of the other Party or its employees
in any publicity, news release or disclosure relating to any of this Agreement,
its subject matter, or the activities of the Parties hereunder without the prior
express written permission of the other Party, except as may be required by Law,
including by the rules or regulations of the United States Securities and
Exchange Commission, the French Financial Markets Authority, the French
Prudential Supervisory Authority or similar regulatory agency in any country
other than the United States or France or of any stock exchange or listing
entity, or except as expressly permitted by the terms hereof.

9.3Press Release.  

9.3.1Following the execution of this Agreement, the Parties shall issue a joint
press release in such form as mutually agreed by the Parties.  After such
initial joint press release, except as provided in Section 9.3.2, neither Party
shall issue a press release or public announcement relating to this Agreement
without the prior written approval of the other Party, which approval shall not
be unreasonably withheld, conditioned or delayed, except that a Party may (i)
once a press release or other public statement is approved in writing by both
Parties, make subsequent public disclosure of the information contained in such
press release or other written statement without the further approval of the
other Party, and (ii) issue a press release or public announcement as required,
in the reasonable judgment of such Party, by Law, including by the rules or
regulations of the United States Securities and Exchange Commission, the French
Financial

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

30

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

Markets Authority, the French Prudential Supervisory Authority or similar
regulatory agency in a country other than the United States or France or of any
stock exchange or listing entity.

9.3.2Notwithstanding anything in this Section 9.3 to the contrary, Alnylam may
issue a press release or make a public disclosure relating to (i) the results of
any Clinical Studies with respect to a Licensed Product and (ii) Alnylam’s
Development or Commercialization activities hereunder, provided that such press
release or public disclosure does not disclose Confidential Information of
Genzyme. [***].

9.4Exclusivity.

9.4.1On a Licensed Product-by-Licensed Product basis, during the Exclusivity
Period for a Licensed Product, Genzyme will not, alone or with an Affiliate or
Third Party, develop or commercialize any siRNA (other than a Licensed Product
as and to the extent permitted under this Agreement) that targets TTR in the
Licensed Territory.

9.4.2At any time during the term of the licenses granted to Alnylam in Section
7.1 (License Grants to Alnylam), Genzyme shall not grant any license or other
right under the Genzyme Technology that is inconsistent with the exclusivity
granted to Alnylam with respect thereto under Sections 7.1.1 (Development
License) and 7.1.2 (Commercialization License).  

9.4.3At any time during the term of the licenses granted to Alnylam in Section
7.1 (License Grants to Alnylam), Genzyme shall not, alone or with an Affiliate
or Third Party, Develop (except as permitted in this Agreement for or on behalf
of Alnylam) or Commercialize any Licensed Product (including any Generic
Product) in any country or territory in the Licensed Territory without the prior
written agreement of Alnylam.

10.

REPRESENTATIONS, WARRANTIES AND COVENANTS

10.1Representations and Warranties of Genzyme.  Except as provided in Schedule
10.1 (Disclosure Schedule) with respect to each Licensed Product, Genzyme
represents and warrants to Alnylam that as of the Effective Date, for each
Licensed Product:

10.1.1     Genzyme is the sole and exclusive owner of, or otherwise Controls,
the Genzyme Technology, and all of the Genzyme Technology licensed to Alnylam
hereunder that is solely and exclusively owned by Genzyme is free and clear of
liens, charges or encumbrances other than licenses granted to Third

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

31

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

Parties that are not inconsistent with the rights and licenses granted to
Alnylam under this Agreement.

10.1.2     Genzyme has sufficient legal and/or beneficial title and ownership
of, or sufficient license rights under, the Genzyme Technology to grant the
licenses to such Genzyme Technology granted to Alnylam pursuant to this
Agreement.

10.1.3     Schedule 1.2.51 sets forth a complete and accurate list of the
Genzyme Patent Rights owned, either solely or jointly, by Genzyme.  In the event
that there are Genzyme Patent Rights existing as of the Effective Date other
than those set forth in Schedule 1.2.51, the Parties will amend Schedule 1.2.51
to include such Genzyme Patent Rights.  

10.1.4     Genzyme has sufficient legal or beneficial title and ownership of, or
sufficient license rights under the Genzyme Know-How to transfer Know-How to
Alnylam as provided in Section 2.2.1 (Scope of Transition Plan).

10.1.5     Genzyme Controls all Know-How and Patent Rights licensed to Genzyme
under Genzyme In-Licenses. Without limiting the generality of the foregoing,
Genzyme has obtained all necessary consents and fulfilled all necessary
conditions, if any, to sublicense to Alnylam under this Agreement such Know-How
and Patent Rights licensed to Genzyme under any Genzyme In-License.

10.1.6   Genzyme has obtained from all inventors of Genzyme Technology owned by
Genzyme valid and enforceable agreements assigning to Genzyme each such
inventor’s entire right, title and interest in and to all such Genzyme
Technology.

10.1.7    There is no (a) claim, demand, suit, proceeding, arbitration, inquiry,
investigation or other legal action of any nature, civil, criminal, regulatory
or otherwise, pending or, to Genzyme’s knowledge, threatened against Genzyme or
any of its Affiliates or (b) judgment or settlement against or owed by Genzyme
or any of its Affiliates, in each case in connection with the Genzyme
Technology.

10.1.8     For each Licensed Product, Schedule 10.1.8 sets forth a complete and
accurate list of all Genzyme In-Licenses.  In the event that there are Genzyme
In-Licenses other than those set forth in Schedule 10.1.8, the Parties will
amend Schedule 10.1.8 to include such Genzyme In-License.

10.2Warranty Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

32

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

REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED,
TO THE OTHER PARTY WITH RESPECT TO ANY TECHNOLOGY, LICENSED PRODUCTS, GOODS,
SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS
ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NON-INFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING. EACH PARTY HEREBY
DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE OR
COMMERCIALIZATION OF ANY LICENSED PRODUCTS PURSUANT TO THIS AGREEMENT WILL BE
SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT TO ANY LICENSED
PRODUCTS WILL BE ACHIEVED.

10.3Certain Covenants.  

10.3.1[***]  

10.3.2[***]

10.3.3[***]

10.3.4[***]

11.

INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

11.1General Indemnification by Genzyme.  Genzyme shall indemnify, hold harmless
and defend Alnylam, its Related Parties, and their respective directors,
officers, employees and agents (“Alnylam Indemnitees”) from and against any and
all Third Party claims, suits, losses, liabilities, damages, costs, fees and
expenses (including reasonable attorneys’ fees and litigation expenses)
(collectively, “Losses”) arising out of or resulting from, directly or
indirectly, (a) any breach of, or inaccuracy in, any representation or warranty
made by Genzyme in this Agreement, or any breach or violation of any covenant or
agreement of Genzyme in or in the performance of this Agreement, or (b) the
negligence or willful misconduct by or of Genzyme and its Related Parties, and
their respective directors, officers, employees and agents in the performance of
Genzyme’s obligations under this Agreement. Genzyme shall have no obligation to
indemnify the Alnylam Indemnitees to the extent that the Losses arise out of or
result from, directly or indirectly, any breach of, or inaccuracy in, any
representation or warranty made by Alnylam in this Agreement, or any breach or
violation of any covenant or agreement of Alnylam in or in the performance of
this Agreement, or the negligence or willful misconduct by or of any of the
Alnylam Indemnitees, or matters for which Alnylam is obligated to indemnify
Genzyme under Section 11.2 (General Indemnification by Alnylam).

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

33

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

11.2General Indemnification by Alnylam.  Alnylam shall indemnify, hold harmless,
and defend Genzyme, its Related Parties and their respective directors,
officers, employees and agents (“Genzyme Indemnitees”) from and against any and
all Losses arising out of or resulting from, directly or indirectly, (a) any
breach of, or inaccuracy in, any representation or warranty made by Alnylam in
this Agreement, or any breach or violation of any covenant or agreement of
Alnylam in or in the performance of this Agreement or (b) the negligence or
willful misconduct by or of Alnylam and its Related Parties, and their
respective directors, officers, employees and agents in the performance of
Alnylam’s obligations under this Agreement. Alnylam shall have no obligation to
indemnify the Genzyme Indemnitees to the extent that the Losses arise out of or
result from, directly or indirectly, any breach of, or inaccuracy in, any
representation or warranty made by Genzyme in this Agreement, or any breach or
violation of any covenant or agreement of Genzyme in or in the performance of
this Agreement, or the negligence or willful misconduct by or of any of the
Genzyme Indemnitees, or matters for which Genzyme is obligated to indemnify
Alnylam under Section 11.1 (General Indemnification by Genzyme).

11.3Product Liability.  Notwithstanding the foregoing, with respect to any
Losses arising out of any Third Party product liability claim arising from the
Development or Commercialization of a Licensed Product, such Losses shall be
allocated between the Parties as follows: (a) with respect to ALN-TTR02,
[***]percent ([***]) by Alnylam on a global basis and (b) with respect to any
other Licensed Product, [***] percent ([***]) by each of Genzyme and Alnylam on
a global basis; provided, however that the obligations of each Party set forth
this Section 11.3 shall be subject to the exceptions set forth in Sections 11.1
and 11.2.

11.4Indemnification Procedure. In the event of any such claim against any
Genzyme Indemnitee or Alnylam Indemnitee (individually, an “Indemnitee”), the
indemnified Party shall promptly notify the other Party in writing of the claim
and the indemnifying Party shall manage and control, at its sole expense, the
defense of the claim and its settlement. The Indemnitee shall cooperate with the
indemnifying Party and may, at its option and expense, be represented in any
such action or proceeding. The indemnifying Party shall not be liable for any
settlements, litigation costs or expenses incurred by any Indemnitee without the
indemnifying Party’s written authorization. Notwithstanding the foregoing, if
the indemnifying Party believes that any of the exceptions to its obligation of
indemnification of the Indemnitees set forth in Sections 11.1 (General
Indemnification by Genzyme) or 11.2 (General Indemnification by Alnylam) may
apply, the indemnifying Party shall promptly notify the Indemnitees, which shall
then have the right to be represented in any such action or proceeding by
separate counsel at their expense, provided that the indemnifying Party shall be
responsible for payment of such expenses if the Indemnitees are ultimately
determined to be entitled to indemnification from the indemnifying Party for the
matters to which the indemnifying Party notified the Indemnitees that such
exception(s) may apply.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

34

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

11.5Limitation of Liability. NEITHER PARTY HERETO SHALL BE LIABLE FOR SPECIAL,
INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR
THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS ARISING FROM OR
RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH
DAMAGES, EXCEPT AS A RESULT OF A PARTY’S WILLFUL MISCONDUCT OR A BREACH OF
SECTION 9 (CONFIDENTIALITY AND PUBLICATION). NOTHING IN THIS SECTION 11.5 IS
INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF
EITHER PARTY.

11.6Insurance. Alnylam shall maintain insurance during the Term and for a period
of at least [***] years after the last commercial sale of any Licensed Product,
with a reputable, solvent insurer in an amount appropriate for its business and
products of the type that are the subject of this Agreement, and for its
obligations under this Agreement. Specifically, Alnylam shall maintain product
liability insurance and clinical trial liability insurance with limits of at
least [***] U.S. Dollars [***] per occurrence and in annual aggregate. Upon
request, Alnylam shall provide Genzyme with evidence of the existence and
maintenance of such insurance coverage.

12.

INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

12.1Inventorship.  Inventorship for inventions and discoveries first made during
the course of the performance of activities pursuant to this Agreement shall be
determined in accordance with United States patent Laws for determining
inventorship.

12.2Ownership.  Alnylam shall own the entire right, title and interest in and to
all inventions and discoveries (and Patent Rights claiming patentable inventions
therein) first made or discovered solely by employees or consultants of Alnylam
or acquired solely by Alnylam in the course of its performance hereunder.

12.3Prosecution and Maintenance of Patent Rights.

 

12.3.1  Genzyme Technology.

(a)Subject to Section 12.3.1(b) below, Genzyme has the sole responsibility, at
Genzyme’s discretion and at Genzyme’s sole cost and expense, to file, prosecute
and maintain (including the defense of any interference or opposition
proceedings), all Patent Rights comprising Genzyme Technology (other than Joint
Collaboration IP), in Genzyme’s name.

(b)In the event that Genzyme elects not to seek or continue to seek or maintain
patent protection on any Genzyme Patent Rights in the Licensed Territory,
Genzyme shall notify Alnylam at least [***] days before any such Patent Rights
would

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

35

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

become abandoned, no longer available or otherwise forfeited, and subject to the
terms and conditions of any applicable Genzyme In-License, Alnylam shall have
the right (but not the obligation), at its expense, to seek, prosecute and
maintain in any country patent protection on such Genzyme Patent Rights in the
name of Genzyme. Genzyme shall use Commercially Reasonable Efforts to make
available to Alnylam its authorized attorneys, agents or representatives, and
such of its employees as are reasonably necessary to assist Alnylam in obtaining
and maintaining the patent protection described under this Section 12.3.1(b).
Genzyme shall sign or use Commercially Reasonable Efforts to have signed, all
legal documents necessary to file and prosecute such patent applications or to
obtain or maintain such patents.

12.3.2Alnylam Technology.  Alnylam has the sole responsibility, at Alnylam’s
discretion and at Alnylam’s sole cost and expense, to file, conduct prosecution
and maintain (including the defense of any interference or opposition
proceedings), all Patent Rights comprising Alnylam Technology, in Alnylam’s
name.

12.3.3Patent Miscellaneous.  Each Party hereby agrees: (a) to make its
employees, agents and consultants reasonably available to the other Party (or to
the other Party’s authorized attorneys, agents or representatives), to the
extent reasonably necessary to enable such Party to undertake patent
prosecution; (b) to provide the other Party with copies of all material
correspondence pertaining to prosecution with the patent offices; (c) to
cooperate, if necessary and appropriate, with the other Party in gaining patent
term extensions wherever applicable to Patent Rights licensed under this
Agreement; and (d) to endeavor in good faith to coordinate its efforts with the
other Party to minimize or avoid interference with the prosecution and
maintenance of the other Party’s patent applications.

12.4Third Party Infringement.  

12.4.1Notices.  Each Party shall promptly report in writing to the other Party
any (a) known or suspected infringement of any Alnylam Technology or Genzyme
Technology or (b) unauthorized use or misappropriation of any Confidential
Information or Know-How of a Party by a Third Party of which it becomes aware,
in each case to the extent such infringing, unauthorized or misappropriating
activities involve, as to the Licensed Products, a competing product in the
Field (a “Competitive Infringement”), and shall provide the other Party with all
available evidence of such infringement, unauthorized use or misappropriation.

12.4.2Rights to Enforce.  Alnylam shall have the sole and exclusive right to
initiate an infringement or other appropriate suit (an “Infringement Action”)
anywhere in the world against any Third Party (i) as to any infringement, or
suspected infringement of, any Alnylam Patent Rights, or as to

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

36

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

any use or suspected use without proper authorization of any Alnylam Know-How,
and (ii) as to any Competitive Infringement, the Genzyme Patent Rights or
Genzyme Know-How with Genzyme’s prior written consent. Genzyme will consider in
good faith any request from Alnylam to initiate an Infringement Action against
any Third Party with respect to any such Competitive Infringement; provided,
however, that Genzyme shall not be required to initiate any such Infringement
Action or permit Alnylam to initiate any such Infringement Action.

12.4.3Procedures; Expenses and Recoveries.  Alnylam shall have the sole and
exclusive right to select counsel for any such Infringement Action and shall pay
all expenses of such Infringement Action, including attorneys’ fees and court
costs and reimbursement of Genzyme’s reasonable out-of-pocket costs in rendering
assistance requested by Alnylam. If required under applicable Law in order for
Alnylam to initiate and/or maintain such Infringement Action, or if Alnylam is
unable to initiate or prosecute such Infringement Action solely in its own name
or it is otherwise advisable to obtain an effective legal remedy, in each case,
Genzyme shall join as a party to such Infringement Action and will execute, and
cause its Affiliates to execute, all documents necessary for Alnylam to initiate
litigation to prosecute and maintain such Infringement Action. In addition, at
Alnylam’s request, Genzyme shall provide reasonable assistance to Alnylam in
connection with an Infringement Action at no charge to Alnylam except for
reimbursement by Alnylam of Genzyme’s reasonable out-of-pocket costs incurred in
rendering such assistance. If Alnylam obtains from a Third Party, in connection
with such Infringement Action, any damages, license fees, royalties or other
compensation (including any amount received in settlement of such litigation),
after payment of any amounts required under any in-licenses, the remaining
amounts shall be allocated in all cases as follows:

 

(i)

first, to reimburse each Party for all expenses of such Infringement Action
incurred by the Parties, including attorneys’ fees and disbursements, court
costs and other litigation expenses;

 

(ii)

second, [***] percent ([***]%) of the balance to be paid to Alnylam; and

 

(iii)

third, the remainder to Genzyme, if the Genzyme Technology was the subject of
the Infringement Action, otherwise the remainder shall be retained by Alnylam.

12.5Patent Term Extensions.    Alnylam will determine, in its sole discretion, a
strategy that will be designed to maximize patent protection and commercial
value for the Licensed Products, and Alnylam, subject to the provisions of any
Genzyme In-License, will seek patent term extensions, restorations and
supplementary protection certificates (“SPCs”), with Genzyme’s prior written
consent, for Alnylam Patent Rights

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

37

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

and Genzyme Patent Rights in accordance with that strategy. Where required under
national law, and subject to the other requirements of this Section 12.5,
Alnylam will make the filings for such extensions, restorations and SPCs.
Genzyme will execute such authorizations and other documents and take such other
actions as may be reasonably requested by Alnylam to obtain any such extensions,
restorations and SPCs in accordance with this Section 12.5.

12.6Common Interest.  All information exchanged between the Parties’
representatives regarding the preparation, filing, prosecution, maintenance, or
enforcement of the Patent Rights under this Section 12 will be deemed
Confidential Information. In addition, the Parties acknowledge and agree that,
with regard to such preparation, filing, prosecution, maintenance and
enforcement of the Patent Rights under this Section 12, the interests of the
Parties as collaborators and licensor and licensee are to obtain the strongest
patent protection possible, and as such, are aligned and are legal in nature.
The Parties agree and acknowledge that they have not waived, and nothing in this
Agreement constitutes a waiver of, any legal privilege concerning the Patent
Rights under this Section 12, including privilege under the common interest
doctrine and similar or related doctrines.

12.7Trademarks.  

(a)Alnylam has the sole and exclusive right to select and develop one or more
Product Trademark(s) for use by Alnylam and its Related Parties throughout the
Licensed Territory. Such Product Trademark(s) may not include Trademarks owned
or Controlled by Genzyme (“Genzyme Trademarks”) and no right or license to any
Alnylam Trademarks are conveyed hereunder to Genzyme.  Alnylam (or its Related
Parties, as appropriate) shall own all rights to Alnylam Trademarks and all
goodwill associated therewith, throughout the Licensed Territory. Alnylam shall
also own rights to any Internet domain names incorporating the applicable
Alnylam Trademarks or any variation or part of such Alnylam Trademarks used as
its URL address or any part of such address.

(b)In the event that Genzyme becomes aware of any infringement of any Product
Trademark by a Third Party, Genzyme shall promptly notify Alnylam and the
Alnylam shall determine the best way to prevent such infringement, including by
the institution of legal proceedings against such Third Party.

12.8Information Exchange during Defense in Patent Litigation.  During the Term,
at a frequency of no less than once per year or at Genzyme’s reasonable request,
and to the extent that Alnylam has actual knowledge, Alnylam shall keep Genzyme
reasonably informed regarding any lawsuit filed anywhere in the world in which
Alnylam is a party, related to (a) Patent Rights Covering a Licensed Product,
(b) any Potential Alnylam In-License (set forth in Schedules 1.2.178 of the
Master Agreement), (c) any

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

38

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

Identified Patent Right (set forth in Schedule 10.2 of the Master Agreement), or
(d) any litigation challenging a Patent Right that Alnylam Controls.

12.9Cooperative Research and Technology (CREATE) Act Acknowledgment.  It is the
intention of the Parties that this Agreement is a “joint research agreement” as
that phrase is defined in Section 35 U.S.C. 103(c).

12.10Requirements for TTR In-Licenses.  

12.10.1In the event that Alnylam desires to enter into an agreement with a Third
Party pursuant to which Alnylam would acquire a license from such Third Party
under any Patent Right that is [***] (a “TTR In-License”), then Alnylam shall
deliver a written notice to Genzyme that includes the identity of such Third
Party, a description of such Patent Rights, and any proposed terms of such TTR
In-License (a “Proposed In-License Notice”); provided, however, that Alnylam
shall not be obligated to deliver a Proposed In-License Notice containing the
foregoing information if (a) Alnylam is restricted from disclosing the proposed
TTR In-License by the terms of a non-disclosure or confidentiality agreement
entered into with the Third Party, (b) Alnylam would also be granting an
exclusive license under any Alnylam Patent Rights to such Third Party under such
proposed TTR In-License or (c) the Patent Rights pertain to Manufacturing and
not to the Development or Commercialization of Licensed Products.  Within [***]
days of the delivery of the Proposed In-License Notice, Alnylam shall present
the proposed TTR In-License to the AJSC, which shall meet to discuss the TTR
In-License (if desired by either Party), and Alnylam shall consider in good
faith comments from Genzyme.  The AJSC will have ultimate decision-making
authority, by consensus and without any tie-breaking authority of either Party,
with respect to any disputes between the Parties as to such TTR In-License that
relate to [***].  If the AJSC cannot resolve any matter within [***] days of it
being referred to them, the Parties shall submit the matter to Baseball
Arbitration (as defined in the Master Agreement), incorporating herein by
reference the applicable provisions of the Master Agreement applicable to such
Baseball Arbitration.  Alnylam shall thereafter keep the AJSC reasonably
informed of negotiations with the Third Party regarding the contemplated TTR
In-License and provide reasonable responses to any questions or requests for
additional information by the AJSC.

12.10.2In entering into any proposed TTR In-License, [***]  Any Patent Rights
licensed to Alnylam under a TTR In-License shall be deemed to be Controlled by
Alnylam for the purposes of the Master Agreement, including the AT3 License
Terms.  If Alnylam enters into any TTR In-License, then Alnylam shall promptly
provide the AJSC and Genzyme with a copy of such TTR In-License.

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

39

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

13.

TERM AND TERMINATION

13.1Term.  This Agreement shall be effective as of the Effective Date and,
unless terminated earlier pursuant to Section 13.2 (Termination Rights), this
Agreement shall continue in effect on a Licensed Product-by-Licensed Product and
country-by-country basis until expiration of the last Royalty Term to expire
under this Agreement (“Term”).  Upon expiration of the Royalty Term for the
Licensed Products, all licenses of the Parties under Section 7 (Licenses) with
respect to the Licensed Products then in effect shall become fully paid-up,
perpetual licenses.  This Agreement shall terminate automatically in the event
that either Party exercises its right to terminate Amendment No. 2 pursuant to
Section 2.4 thereof.

13.2Termination Rights.    This Agreement may be terminated by the Parties only
as set forth in Amendment No. 2 or this Section 13.2.

13.2.1Termination of Licensed Products for Convenience.  Subject to the
remainder of this Section 13, Alnylam shall have the right to terminate this
Agreement with respect to any or all Licensed Products at any time after the
Effective Date on six (6) months prior written notice to Genzyme.

13.2.2Termination of Licensed Products for Cause. This Agreement may be
terminated, on a Licensed Product-by-Licensed Product basis, with respect to any
Licensed Product at any time during the Term upon written notice by either Party
if (a) the other Party is in material breach of its obligations hereunder with
respect to such Licensed Product, (b) such material breach relates to such
Licensed Product and (c) the other Party has not cured such breach within [***]
days in the case of a payment breach, or within [***] days in the case of all
other breaches, after notice requesting cure of the breach; provided, however,
that if any breach other than a payment breach is not reasonably curable within
[***] days and if a Party is making a bona fide effort to cure such breach, such
termination shall be delayed for a time period to be agreed by both Parties, not
to exceed an additional [***] days, in order to permit such Party a reasonable
period of time to cure such breach; provided, further, that in the event that
the breach relates to a dispute between the Parties regarding Alnylam’s
obligations to use Commercially Reasonable Efforts in Developing or
Commercializing such Licensed Product and Alnylam disputes whether it has
breached such obligation or whether such breach gives Genzyme the right to
terminate this Agreement with respect to such Licensed Product and initiates a
legal action against Genzyme to resolve such dispute within the foregoing [***]
day cure period, then this Agreement shall not terminate during the pendency of
such legal action, provided that if (i) Alnylam is found, in an unappealable
decision by a court of competent jurisdiction or an appealable decision of a
court of competent jurisdiction that has not been appealed in the time allowed
for an appeal in such legal action, to have materially breached this Agreement
with respect to such Licensed Product, or (ii)

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

40

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

Alnylam admits in such legal action or settlement thereof that it has materially
breached this Agreement with respect to such Licensed Product, then, upon
written notice by Genzyme, this Agreement shall terminate immediately with
respect to such Licensed Product following the Parties’ receipt of such decision
or immediately following such admission, as applicable.

13.2.3Challenges of Patent Rights.  If, during the Term, Alnylam or any of its
Affiliates (a) commences or participates in any action or proceeding (including
any patent opposition or re-examination proceeding), or otherwise asserts any
claim, challenging or denying the validity or enforceability of any claim within
the Genzyme Patent Rights or (b) actively assists any other Person in bringing
or prosecuting any action or proceeding (including any patent opposition or
re-examination proceeding) challenging or denying the validity or enforceability
of any claim of such Patent Rights (each of (a) and (b), a “Patent Challenge”),
then, to the extent permitted by the applicable Laws, Genzyme shall have the
right, exercisable within [***] days following receipt of notice regarding such
Patent Challenge, in its sole discretion, to give notice to Alnylam that Genzyme
may terminate this Agreement [***] days following such notice (or such longer
period as Genzyme may designate in such notice), and, unless Alnylam or such
Affiliate withdraws or causes to be withdrawn all such challenge(s) (or in the
case of ex-parte proceedings, multi-party proceedings, or other Patent
Challenges that Alnylam or Alnylam’s Affiliates do not have the power to
unilaterally withdraw or cause to be withdrawn, Alnylam and Alnylam’s Affiliates
cease actively assisting any other party to such Patent Challenge and, to the
extent Alnylam or an Alnylam Affiliate is a party to such Patent Challenge, it
withdraws from such Patent Challenge) within such [***]-day period, Genzyme
shall have the right to terminate this Agreement by providing written notice
thereof to Alnylam.  The foregoing sentence shall not apply with respect to any
Patent Challenge commenced by a Third Party that after the Effective Date
acquires or is acquired by Alnylam or its Affiliates or its or their business or
assets, whether by stock purchase, merger, asset purchase or otherwise, but only
with respect to Patent Challenges commenced prior to the closing of such
acquisition.

13.3Effect of Termination; Alternative Remedy.  

13.3.1Effects of Termination of Licensed Products by Alnylam for Cause;
Alternative Remedy.

13.3.1.1Without limiting any other legal or equitable remedies that either Party
may have, if this Agreement is terminated by Alnylam with respect to any
Licensed Products pursuant to Section 13.2.2 (Termination of Licensed Products
for Cause), then the provisions of this Section 13.3.1.1 shall apply:

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

41

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

(a)This Agreement shall terminate with respect to the rights and licenses
granted to Alnylam for such terminated Licensed Products but shall continue to
survive in all respects with respect to all Licensed Products other than the
terminated Licensed Products.

(b)Each Party shall promptly pay any amounts owed to the other Party as of the
effective date of such termination.

13.3.1.2If Alnylam has the right to terminate this Agreement with respect to any
or all Licensed Products pursuant to Section 13.2.2 (Termination of Licensed
Products for Cause), then Alnylam may, by written notice to Genzyme, opt not to
terminate the Agreement pursuant to Section 13.2.2 (Termination of Licensed
Products for Cause) but instead to continue the Agreement in full force and
effect; provided that, as of the expiration of the cure period applicable to
such material breach by Genzyme and for the remainder of the applicable Royalty
Term hereunder, the royalty rates payable by Alnylam on Net Sales of such
Licensed Products as under determined under Section 8.1 (Royalties) shall be
reduced by [***] percent ([***]%).

13.3.2Effects of Termination of Licensed Products by Genzyme for Cause or by
Alnylam for Convenience.  Without limiting any other legal or equitable remedies
that either Party may have, if this Agreement is terminated with respect to any
Licensed Products by Alnylam pursuant to Section 13.2.1 (Termination of Licensed
Products for Convenience) or by Genzyme pursuant to Section 13.2.2 (Termination
of Licensed Products for Cause), then the provisions of this Section 13.3.2
shall apply:

(a)This Agreement shall terminate with respect to the rights and licenses
granted to Alnylam for such terminated Licensed Products but shall continue to
survive in all respects with respect to all Licensed Products other than the
terminated Licensed Products.

(b)Each Party shall promptly pay any amounts owed to the other Party as of the
effective date of such termination.

(c)Alnylam and its Related Parties shall cease all Development and
Commercialization of the Licensed Products throughout the Territory.

13.4Effect of Expiration or Termination; Survival.  Any expiration or
termination of this Agreement (a) shall not relieve the Parties of any
obligation accruing prior to such expiration or termination and (b) shall be
without prejudice to the rights of either Party against the other Party accrued
or accruing under this Agreement prior to such expiration or termination,
including the obligation to pay royalties for any Licensed

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

42

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

Products sold prior to such expiration or termination.  If this Agreement
expires or is terminated with respect to any Licensed Products, the following
provisions shall survive with respect to such Licensed Products: Sections 1
(Definitions), 8 (Certain Financial Terms), 9.1 (Nondisclosure Obligations),
10.2 (Warranty Disclaimer), 11 (Indemnification; Limitation of Liability;
Insurance), 12.1 (Inventorship), 12.2 (Ownership), 13.1 (Term), 13.3 (Effect of
Termination; Alternative Remedy), and 13.4 (Effect of Expiration or Termination;
Survival) and 15 (Miscellaneous).  Section 8.3.4 (Royalty Floor) shall survive
any termination or expiration of this Agreement with respect to royalties
accruing prior to such termination or expiration. Section 8 (Certain Financial
Terms) shall survive for so long as any royalties are due under this Agreement
plus three (3) years. Except as otherwise set forth in this Section 13, upon
termination or expiration of this Agreement in its entirety (i.e., with respect
to all Licensed Products), all rights and obligations of the Parties under this
Agreement shall cease.  

14.

PERFORMANCE BY AFFILIATES

14.1Use of Affiliates. Each Party acknowledges and accepts that the other Party
may exercise its rights and perform its obligations under this Agreement either
directly or through one or more of its Affiliates. A Party’s Affiliates will
have the benefit of all rights (including all licenses) of such Party under this
Agreement. Accordingly, in this Agreement “Genzyme” will be interpreted to mean
“Genzyme and/or its Affiliates” and “Alnylam” will be interpreted to mean
“Alnylam and/or its Affiliates” where necessary to give each Party’s Affiliates
the benefit of the rights provided to such Party in this Agreement; provided,
however, that in any event each Party will remain responsible for the acts and
omissions, including financial liabilities, of its Affiliates.

14.2Acquired Programs.

14.2.1[***]  

14.2.2[***]

15.

MISCELLANEOUS

15.1Incorporation by Reference of Master Agreement Provisions.  Sections 13.1
through 13.4 and Sections 13.6 through 13.15 (inclusive) of the Master Agreement
are hereby incorporated by reference, mutatis mutandis.

15.2Entire Agreement; Amendments.  This Agreement, the AT3 License Terms and
Amendment No. 2 contain the entire understanding of the Parties with respect to
the subject matter hereof, and supersede all previous arrangements with respect
to the subject matter hereof, whether written or oral.  This Agreement may be
amended, or any term hereof modified, only by a written instrument duly-executed
by authorized representatives of both Parties hereto.  

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

43

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

15.3Binding Effect; No Third Party Beneficiaries.  As of the Effective Date,
this Agreement shall be binding upon and inure to the benefit of the Parties and
their respective permitted successors and permitted assigns. Except as expressly
set forth in this Agreement, no Person other than the Parties and their
respective Affiliates and permitted assignees hereunder shall be deemed an
intended beneficiary hereunder or have any right to enforce any obligation of
this Agreement.

[Remainder of page intentionally left blank]

 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

44

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

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Execution
Date.

GENZYME CORPORATION

ALNYLAM PHARMACEUTICALS, INC.

BY:/s/ William J. Sibold_______________

NAME: William J. Sibold______________

TITLE: CEO of Genzyme Corporation____

BY:/s/ John M. Maraganore__________

NAME: John M. Maraganore, Ph.D.

TITLE: Chief Executive Officer

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

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

Exhibit A

HIGH LEVEL TRANSITION OUTLINE

This High Level Transition Summary outlines certain categories of deliverables
and general transfer procedures anticipated to be included in the Transition
Plan to be developed by the Joint Transition Team after the Execution Date in
accordance with this Agreement.  Additional categories of deliverables or
procedures may be identified after the Execution Date and included in the
Transition Plan, and the omission of such additional category of deliverables or
procedures from this Transition Summary shall not constitute a basis for
excluding them from the Transition Plan.  

In addition to those activities to be conducted under the Transition Plan,
during the Transition Period and until such information are fully transferred to
Alnylam, at Alnylam’s request and subject in all cases to Section 2.2
(Transition) of the Agreement and the Transition Plan, Genzyme will continue to
conduct each existing or contemplated ALN-TTR02 Execution Activities in the
ordinary course, including with respect to program management, and regulatory
interactions & filings.

[***]

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

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

 

SCHEDULE 1.2.12

ALN-TTRSC02

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 1 page was omitted.

 

[***]

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

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

 

SCHEDULE 1.2.51

GENZYME PATENT RIGHTS

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 1 page was omitted.

 

[***]

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

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

 

SCHEDULE 1.2.64

JOINT COLLABORATION PATENT RIGHTS

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 1 page was omitted.

 

[***]

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

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

 

SCHEDULE 10.1

DISCLOSURE SCHEDULE

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 1 page was omitted.

 

[***]

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.

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

 

SCHEDULE 10.1.8

GENZYME IN-LICENSES

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 1 page was omitted.

 

[***]

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.