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Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
ALNYLAM PHARMACEUTICALS, INC.
AND
BIOGEN IDEC MA INC.
Confidential
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement dated the 20th day of
September, 2006
(the "Execution Date") is by and between Alnylam
Pharmaceuticals, Inc., a
corporation organized and existing under the laws of the State
of Delaware and
having its principal office at 300 Third Street, Third Floor,
Cambridge,
Massachusetts 02142 ("Alnylam"), and Biogen Idec MA Inc., a
corporation
organized and existing under the laws of the Commonwealth of
Massachusetts and
having its principal office at 14 Cambridge Center, Cambridge,
MA 02142 ("Biogen
Idec").
INTRODUCTION
WHEREAS, Alnylam has developed technology useful for the
discovery, development,
manufacture, characterization or use of therapeutic products
that function
through RNA interference;
WHEREAS, Biogen Idec is in the business of discovering,
developing,
manufacturing and commercializing human therapeutic
products;
WHEREAS, Alnylam and Biogen Idec are interested in
collaborating, on the terms
and conditions set forth herein, in the discovery and
development of RNAi
Therapeutics (as defined below) directed to the JC virus for use
in the Field
(as defined below).
NOW, THEREFORE, Alnylam and Biogen Idec agree as follows:
ARTICLE 1
DEFINITIONS
When used in this Agreement, each of the following terms shall
have the meanings
set forth in this Article 1:
1.1 "ACTIVE IND" means an IND submitted to a Regulatory
Authority by
Biogen Idec or an Affiliate where such Regulatory Authority did
not
notify Biogen Idec or such Affiliate within thirty (30) days of
such
submission that it may not proceed under such IND.
1.2 "AFFILIATE" means any corporation, company, partnership,
joint venture
and/or firm which controls, is controlled by, or is under
common
control with a specified person or entity. For purposes of
this
Section 1.2, "control" shall be presumed to exist if one of
the
following conditions is met: (a) in the case of corporate
entities,
direct or indirect ownership of at least fifty percent (50%) of
the
stock or shares having the right to vote for the election of
directors, and (b) in the case of non-corporate entities, direct
or
indirect ownership of at least fifty percent (50%) of the
equity
interest with the power to direct the management and policies of
such
non-corporate entities. The Parties acknowledge that in the case
of
certain entities organized under the laws of certain countries
outside
of the United States, the maximum percentage ownership permitted
by
law for a foreign investor may
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be less than fifty percent (50%), and that in such case such
lower
percentage shall be substituted in the preceding sentence,
provided
that such foreign investor has the power to direct the
management and
policies of such entity.
1.3 "ALNYLAM COLLABORATION IP" means (a) any improvement,
discovery or
Know-How, patentable or otherwise, first identified, discovered
or
developed solely by employees of Alnylam or its Affiliates, or
other
persons not employed by Biogen Idec acting on behalf of Alnylam,
under
the Collaboration, and (b) any Patent Rights in the Territory
which
claim, cover or relate to such improvements, discoveries or
Know-How
and are Controlled by Alnylam at any time during the
Collaboration
Term. Alnylam Collaboration IP excludes Alnylam's interest in
Joint
Collaboration IP.
1.4 "ALNYLAM IN-LICENSE" means an agreement between Alnylam and
a Third
Party pursuant to which Alnylam has rights and obligations
with
respect to, or which otherwise Cover, an RNAi Therapeutic and
which is
necessary to Discover, Develop, Commercialize and/or Manufacture
an
RNAi Therapeutic directed to JCV in the Field in the
Territory,
including without limitation the Existing Alnylam
In-Licenses.
1.5 "ALNYLAM KNOW-HOW" means Know-How that is either (a)
Controlled by
Alnylam on the Effective Date, or (b) comes within Alnylam's
Control
during the Term (other than Alnylam's rights in Joint
Collaboration IP
and Alnylam Collaboration IP).
1.6 "ALNYLAM PATENT RIGHTS" means Patent Rights that (a) claim
(i) Alnylam
Know-How, or (ii) the identification, characterization,
optimization,
construction, expression, use or production of an RNAi
Therapeutic,
and which are useful or necessary to Discover, Develop,
Commercialize
and/or Manufacture a Selected RNAi Therapeutic in the Field in
the
Territory, and (b) are Controlled by Alnylam at any time during
the
Collaboration Term. As of the Execution Date, Alnylam Patent
Rights
include, without limitation, those listed on Schedule 1.6.
Alnylam
Patent Rights shall not include Patent Rights included in
Alnylam
Collaboration IP.
1.7 "ALNYLAM TECHNOLOGY" means, collectively, Alnylam Know-How,
Alnylam
Patent Rights, Alnylam Collaboration IP and Alnylam's interest
in
Joint Collaboration IP.
1.8 "ANNUAL WORK PLAN" means the master plan for a given
Contract Year for
the Discovery Program and the Development Program, an initial
draft of
which is set forth in Schedule 1.8 for the first Contract Year,
as
updated and approved by the Joint Steering Committee as
necessary
during each subsequent Contract Year.
1.9 "BACK-UP CANDIDATE" means the RNAi Therapeutic directed to
JCV that
[**] and has been [**] as a back-up [**].
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1.10 "BIOGEN IDEC COLLABORATION IP" means (a) any improvement,
discovery or
Know-How, patentable or otherwise, first identified, discovered
or
developed solely by employees of Biogen Idec or its Affiliates
or
other persons not employed by Alnylam acting on behalf of Biogen
Idec,
under the Collaboration, and (b) any Patent Rights in the
Territory
which claim, cover or relate to such improvements, discoveries
or
Know-How and are Controlled by Biogen Idec at any time during
the
Collaboration Term. Biogen Idec Collaboration IP excludes
Biogen
Idec's interest in Joint Collaboration IP.
1.11 "BIOGEN IDEC IN-LICENSE" means an agreement between Biogen
Idec and a
Third Party pursuant to which Biogen Idec has rights and
obligations
with respect to, or which otherwise Cover, an RNAi Therapeutic
and is
necessary to Discover, Develop, Commercialize and/or Manufacture
a
Selected RNAi Therapeutic in the Field in the Territory. Biogen
Idec
In-Licenses as of the Execution Date are listed on Schedule
1.11.
1.12 "BIOGEN IDEC KNOW-HOW" means Know-How that is either (a)
Controlled by
Biogen Idec on the Effective Date, or (b) comes within Biogen
Idec's
Control during the Collaboration Term (other than Biogen Idec's
rights
in Joint Collaboration IP and Biogen Idec Collaboration IP).
1.13 "BIOGEN IDEC PATENT RIGHTS" means Patent Rights that (a)
claim (i)
Biogen Idec Know-How, or (ii) the identification,
characterization,
optimization, construction, expression, use or production of an
RNAi
Therapeutic, and which is useful or necessary to Discover,
Develop,
Commercialize and/or Manufacture RNAi Therapeutics in the Field
in the
Territory, and (b) are Controlled by Biogen Idec at any time
during
the Collaboration Term. Biogen Idec Patent Rights shall not
include
Patent Rights included in Biogen Idec Collaboration IP.
1.14 "BIOGEN IDEC TECHNOLOGY" means, collectively, Biogen Idec
Know-How,
Biogen Idec Patent Rights, Biogen Idec Collaboration IP and
Biogen
Idec's interest in Joint Collaboration IP.
1.15 "BLOCKING RNAi TECHNOLOGY" means Biogen Idec Collaboration
IP
comprising Broad RNAi Technology which would, in the absence of
a
license from Biogen Idec, be infringed by the practice of
any
invention claimed in a Valid Claim of the Alnylam Patent
Rights
existing at the end of the Discovery Term.
1.16 "BROAD RNAi TECHNOLOGY" means any and all Know-How, whether
or not
patentable, that (a) is useful for the identification,
characterization, optimization, construction, expression, use
or
production of an RNAi Therapeutic, (b) arises from or is
necessary for
the performance of the Collaboration and (c) which relates
to
structural features, properties, motifs, synthesis,
analysis,
modifications, delivery and/or uses of siRNAs that has broader
utility
beyond the specific embodiments represented by an RNAi
Therapeutic
directed to JCV and/or particular uses of such RNAi
Therapeutic.
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1.17 "BROAD RNAi TECHNOLOGY COLLABORATION IP" means Joint
Collaboration IP
that constitutes Broad RNAi Technology.
1.18 "BUSINESS DAY" means a day on which banking institutions in
Boston,
Massachusetts are open for business.
1.19 "CLINICAL PROOF OF CONCEPT" means, with respect to a
Selected RNAi
Therapeutic, either (a) [**] data from a clinical trial of
such
Selected RNAi Therapeutic [**]:
(i) [**]; or
(ii) [**].
1.20 "COLLABORATION" means the activities contemplated under
this Agreement
aimed at the Discovery of RNAi Therapeutics directed to JCV, and
the
Development and Manufacture of the Selected RNAi
Therapeutics.
1.21 "COLLABORATION TERM" means the period commencing on the
Effective Date
and ending on the earlier of (a) Regulatory Approval of a
Selected
RNAi Therapeutic anywhere in the Territory, and (b) the
Established
Utilization Date.
1.22 "COMMERCIALIZATION" or "COMMERCIALIZE" means any activity
to
distribute, market, sell and/or have sold an approved Selected
RNAi
Therapeutic.
1.23 "COMMERCIALLY REASONABLE EFFORTS" means the carrying out
of
obligations in a diligent and sustained manner using such effort
and
employing such resources (a) in Alnylam's case, as would
normally be
exerted or employed by a similarly situated biopharmaceutical
company
for a product of similar strategic importance, and at a similar
stage
of its product life, based on conditions then prevailing; and
(b) in
Biogen Idec's case, that are substantially similar to the effort
and
resources Biogen Idec would devote to a product of similar
commercial
or strategic importance, and at a similar stage of its product
life,
taking into consideration safety and efficacy, development
costs, the
anticipated prescription label, all payments due to Alnylam
under this
Agreement and all other relevant factors, taking into account
the
nature of the JCV RNAi Therapeutic and the clinical setting in
which
it is expected to be used. Commercially Reasonable Efforts shall
be
determined on a country-by-country basis.
1.24 "CONFIDENTIAL INFORMATION" means any and all information
and data,
including without limitation all Alnylam Technology and Biogen
Idec
Technology, 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 provided by one Party to the other
Party in
connection with this Agreement.
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1.25 "CONTRACT YEAR" means the twelve (12) month period
beginning on the
Effective Date and each succeeding twelve (12) month period
thereafter
during the Term. Each Contract Year shall be divided into four
(4)
"Contract Quarters" comprised of successive three (3) month
periods.
1.26 "CONTROL" or "CONTROLLED" means with respect to any (a)
material, item
of information, method, data or other know-how, or (b)
intellectual
property right, the possession (whether by ownership or license,
other
than pursuant to this Agreement) by a Party or its Affiliates of
the
ability to grant to the other Party access and/or a license
as
provided herein under such item or right without violating the
terms
of any agreement or other arrangement with any Third Party
existing
before or after the Effective Date.
1.27 "CORE JCV PATENTS" means Patent Rights Controlled by
Alnylam, the
claims of which are specifically directed to (a) RNAi
Therapeutics in
the Field, or (b) the manufacture or use of RNAi Therapeutics in
the
Field. As of the Effective Date, Core JCV Patents include
those
patents and applications set forth on Schedule 1.27.
1.28 "COST OF GOODS" means, with respect to a Selected RNAi
Therapeutic,
the reasonable internal and external costs of Alnylam incurred
in
Manufacturing such Selected RNAi Therapeutic (including
[**]),
including: (a) to the extent that such Selected RNAi Therapeutic
is
sourced from Alnylam, the [**] cost of Manufacture of such
Selected
RNAi Therapeutic, consisting of [**], all calculated in
accordance
with generally accepted accounting principles in the United
States
consistently applied by Alnylam, and (b) to the extent that
such
Selected RNAi Therapeutic is sourced from a Third Party
manufacturer,
the actual price paid by Alnylam to the Third Party [**]. Cost
of
Goods shall not include [**].
1.29 "COVERING", "COVER", or "COVERED" means, with respect to an
RNAi
Therapeutic, that in the absence of a license granted under a
Valid
Claim, the Discovery, Development, Manufacture or
Commercialization of
the RNAi Therapeutic would infringe such Valid Claim.
1.30 "DEVELOPMENT" or "DEVELOP" means any preclinical and
clinical activity
to develop a Selected RNAi Therapeutic, beginning with
IND-Enabling
GLP Toxicology Studies and ending upon Regulatory Approval
and
completion of any post-approval regulatory commitments.
1.31 "DEVELOPMENT CANDIDATE" means the RNAi Therapeutic directed
to JCV
that meets the Development Criteria and has been selected by
Biogen
Idec pursuant to Section 2.2 for further Development and
Commercialization.
1.32 "DEVELOPMENT CRITERIA" means the written criteria developed
by the
Parties and approved by the Joint Steering Committee, and
included in
the Annual Work Plan, for an RNAi Therapeutic directed to JCV
to
qualify as a Selected RNAi Therapeutic.
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1.33 "DEVELOPMENT MATERIALS" means animal models, cell lines,
tissue
samples, genes, plasmids, siRNAs, constructs, vectors, receptors
and
other proteins, peptides, and other biological materials related
to
RNAi Therapeutics that in each case are used in or that may
be
necessary or useful to conduct the Collaboration.
1.34 "DISCOVERY" or "DISCOVER" means any and all activities to
discover and
characterize potential Development Candidates during the
Discovery
Term prior to the initiation of IND-Enabling Toxicology
Studies,
including without limitation, the research and development
activities
related to the generation, characterization, optimization,
construction, synthesis, use and production of potential
Development
Candidates.
1.35 "DISCOVERY TERM" means the period commencing on the
Effective Date and
continuing until the earlier to occur of (a) Alnylam having
notified
Biogen Idec of the Discovery of [**], or (b) the last date of
the
third Contract Year of the Term.
1.36 "EFFECTIVE DATE" means September 20, 2006.
1.37 "EMEA" means the European Medicines Agency and any
successor agency
having substantially the same functions.
1.38 "ESTABLISHED UTILIZATION" means the [**].
1.39 "ESTABLISHED UTILIZATION YEAR" means the twelve (12) month
period
beginning on the Established Utilization Date and each
succeeding
twelve (12) month period thereafter. Each Established
Utilization Year
shall be divided into four (4) "Established Utilization
Quarters"
comprised of successive three (3) month periods.
1.40 "EXECUTIVE OFFICERS" means the Chief Executive Officer of
Biogen Idec
(or an executive of Biogen Idec designated by such Chief
Executive
Officer) and the Chief Executive Officer of Alnylam (or an
executive
of Alnylam designated by such Chief Executive Officer).
1.41 "EXISTING ALNYLAM IN-LICENSES" means the Third Party
agreements listed
on Schedule 1.41, redacted copies of which have been provided
to
Biogen Idec prior to the Execution Date, as such schedule may
be
amended pursuant to Section 4.5.
1.42 "FDA" means the United States Food and Drug Administration,
or a
successor agency thereto.
1.43 "FIELD" means the prophylaxis and/or treatment of PML.
1.44 "IND" means an Investigational New Drug application,
Clinical Study
Application, Clinical Trial Exemption, or similar application
or
submission for approval to conduct human clinical investigations
filed
with or submitted to a Regulatory Authority in conformance with
the
requirements of such Regulatory Authority.
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1.45 "IND-ENABLING GLP TOXICOLOGY STUDIES" means genotoxicity,
acute
toxicology, safety pharmacology, and sub-chronic toxicology
studies in
species that satisfy applicable regulatory requirements
using
applicable good laboratory practices which meet the standard
necessary
for submission as part of an IND filing with a Regulatory
Authority.
1.46 "IN-LICENSES" means collectively, the Alnylam In-Licenses
and the
Biogen Idec In-Licenses.
1.47 "JCV" means the human polyomavirus known as JC virus.
1.48 "JCV RNAi THERAPEUTIC" means the [**].
1.49 "JOINT COLLABORATION IP" means, collectively, (a) any
improvement,
discovery or Know-How, patentable or otherwise, first
identified,
discovered or developed jointly by the Parties or their
Affiliates or
others acting on behalf of Biogen Idec and Alnylam under the
Collaboration, and (b) any Patent Rights in the Territory which
claim,
cover or relate to such improvements, discoveries or
Know-How.
1.50 "KNOW-HOW" means, with respect to an RNAi Therapeutic, all
biological
materials and other tangible materials, inventions,
practices,
methods, protocols, formulas, knowledge, know-how, trade
secrets,
processes, assays, skills, experience, techniques and results
of
experimentation and testing, including without limitation
pharmacological, toxicological and pre-clinical and clinical
test data
and analytical and quality control data, patentable or
otherwise,
which relates to the identification, characterization,
optimization,
construction, expression, use or production of such RNAi
Therapeutic
and which are reasonably useful or necessary to Discover,
Develop,
Manufacture or Commercialize such RNAi Therapeutic in the Field
in the
Territory.
1.51 "LINKED PRODUCT" means [**].
1.52 "MAJOR MARKET" means any of the United States, the European
Union,
United Kingdom, France, Germany, Italy, Spain or Japan.
1.53 "MANUFACTURING" or "MANUFACTURE" means, as applicable, all
activities
associated with the production, manufacture, processing,
filling,
finishing, packaging, labeling, shipping, and storage of
RNAi
Therapeutics, including process and formulation development,
process
validation, stability testing, manufacturing scale-up,
pre-clinical,
clinical and commercial manufacture and analytical
development,
product characterization, quality assurance and quality
control,
whether such activities are conducted by a Party, its Affiliates
or a
Third Party contractor of such Party.
1.54 "NDA" means a New Drug Application, Biologics License
Application,
Worldwide Marketing Application, Marketing Authorization
Application,
Section 510(k) filing or similar application or submission filed
with
a Regulatory
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Authority in a country or group of countries to obtain
marketing
approval for a biological, pharmaceutical or other therapeutic
product
in that country or in that group of countries.
1.55 "NET SALES" means, with respect to the Selected RNAi
Therapeutics, the
aggregate gross invoice prices of all units of such Selected
RNAi
Therapeutics sold by Biogen Idec and its Related Parties to
Third
Parties (other than a Sublicensee of Biogen Idec) after
deducting, if
not previously deducted, from the amount invoiced or received
(a)
trade and quantity discounts actually given other than early pay
cash
discounts; (b) returns, rebates, chargebacks and other
allowances
actually given; and (c) retroactive price reductions that are
actually
granted.
Notwithstanding the foregoing, in the event a Selected RNAi
Therapeutic is sold in conjunction with another clinically
active
therapeutic, prophylactic or diagnostic ingredient or
component
(whether packaged together or in the same formulation) (a
"Combination
Product"), Net Sales shall be calculated by multiplying the Net
Sales
of such Combination Product by a fraction, the numerator of
which
shall be the fair market value of the Selected RNAi
Therapeutic
included in such Combination Product as if sold separately
(determined
in accordance with generally accepted accounting principles),
and the
denominator of which shall be the aggregate fair market value of
all
the proprietary active ingredients of such Combination
Product,
including the Selected RNAi Therapeutic, as if sold separately.
In the
event no such separate sales are made by Biogen Idec or its
Related
Parties, Net Sales of the Combination Product shall be
calculated in a
manner to be negotiated and agreed upon by the Parties,
reasonably and
in good faith, prior to any sale of such Combination Product,
which
shall be based upon the respective estimated commercial values
of the
active components of such Combination Product.
All references to Selected RNAi Therapeutics in this Agreement
shall
be deemed to include Combination Product, to the extent
applicable.
As provided in Section 5.4.3(b)(ii), Biogen Idec's or any of
its
Related Parties' transfer of Selected RNAi Therapeutics to
another
Related Party shall not result in any Net Sales, unless such
Selected
RNAi Therapeutic is consumed by such Related Party in the course
of
its commercial activities.
1.56 "PARTY" or "PARTIES". "Party" means Biogen Idec or Alnylam;
"Parties"
means Biogen Idec and Alnylam.
1.57 "PATENT RIGHTS" means all patents (including all reissues,
extensions,
substitutions, confirmations, re-registrations,
re-examinations,
invalidations, supplementary protection certificates and patents
of
addition) and patent applications (including all provisional
applications, continuations, continuations-in-part and
divisions).
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1.58 "PML" means progressive multifocal leukoencephalopathy.
1.59 "PRODUCT TRADEMARKS" means the trademark(s), service
mark(s),
accompanying logos, trade dress and/or indicia of origin used
in
connection with the distribution, marketing, promotion and sale
of
each Selected RNAi Therapeutic in the Territory. For purposes
of
clarity, the term Product Trademark(s) shall not include,
without
limitation, the corporate names and logos of either Party, and
shall
include any internet domain names incorporating such Product
Trademarks.
1.60 "REGULATORY APPROVAL" means the approval of the applicable
Regulatory
Authority necessary for the marketing and sale of a Selected
RNAi
Therapeutic in a particular indication in the Field in a
country,
including, where required, separate pricing and/or
reimbursement
approvals.
1.61 "REGULATORY AUTHORITY" means any applicable government
regulatory
authority involved in granting approvals for the
Development,
Manufacturing, or Commercialization of a Selected RNAi
Therapeutic in
the Territory, including without limitation the FDA and the
EMEA.
1.62 "RELATED PARTY" means Biogen Idec's Affiliates and
permitted
Sublicensees, which term does not include wholesale distributors
of
Biogen Idec or its Affiliates, who purchase a Selected RNAi
Therapeutic from Biogen Idec or its Affiliates in an arm's
length
transaction and who have no other obligation, including
without
limitation a reporting obligation, to Biogen Idec or its
Affiliates.
1.63 "RNAi THERAPEUTIC" means a therapeutic product containing,
comprised
of or based on one or more siRNAs or siRNA derivatives or
other
moieties effective in gene function modulation and designed
to
modulate the function of particular genes or gene products
through RNA
interference.
1.64 "SELECTED RNAi THERAPEUTIC" means the [**].
1.65 "SELECTED RNAi THERAPEUTICS" means, collectively, [**].
1.66 "siRNA" means a double-stranded ribonucleic acid (RNA)
composition
designed to act primarily through an RNA interference mechanism
that
consists of either (a) two separate oligomers of native or
chemically
modified RNA that are hybridized to one another along a
substantial
portion of their lengths, or (b) a single oligomer of native
or
chemically modified RNA that is hybridized to itself by
self-complementary base-pairing along a substantial portion of
its
length to form a hairpin.
1.67 "SUBLICENSEE" means a Third Party to whom a Party grants a
sublicense
under any Alnylam Technology (in the case of Biogen Idec),
Biogen Idec
Technology (in the case of Alnylam) or Joint Collaboration IP
(in the
case of either Party) as permitted under this Agreement.
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1.68 "TERRITORY" means all the countries of the world.
1.69 "THIRD PARTY" means any person or entity other than a Party
or any of
its Affiliates.
1.70 "VALID CLAIM" means a claim of: (a) an issued and unexpired
Patent
Right, which claim has not been revoked or held
unenforceable,
unpatentable or invalid by a decision of a court or other
governmental
agency of competent jurisdiction, which is not appealable or has
not
been appealed within the time allowed for 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 for a patent included
within
the Patent Rights that has been pending less than [**] years
from the
earliest date on which such patent application claims priority
and
which claim has not been cancelled, withdrawn or abandoned or
finally
rejected by an administrative agency action from which no appeal
can
be taken.
1.71 ADDITIONAL DEFINITIONS. The following terms have the
meanings set
forth in the corresponding Sections of this Agreement:
<TABLE>
<CAPTION>
TERM SECTION
---- -------
<S> <C>
"AGREEMENT TERM" 8.1
"ALNYLAM INDEMNITEES" 9.5.1
"BANKRUPT PARTY" 8.2.2(c)
"BIOGEN IDEC INDEMNITEES" 9.5.2
"BREACHING PARTY" 8.2.1
"CODE" 8.2.2(c)
"COLLABORATION MANAGER" 3.2
"COMBINATION PRODUCT" 1.53
"[**] SUBLICENSE AGREEMENT" 4.5
"DEFENDING PARTY" 6.5.3
"DEVELOPMENT PROGRAM" 2.3
"DISCOVERY PROGRAM" 2.2
"ELAN" 10.2.2
"ESTABLISHED UTILIZATION DATE" 5.3
"FTE" 5.1.1
"FTE RATE" 5.1.1
"GRANTING PARTY" 4.1.5
"INDEMNITEE" 9.5.4
"INFRINGEMENT CLAIM" 6.5.1
"INITIAL ENFORCEMENT RIGHTS PARTY" 6.4.3
"JSC" OR "JOINT STEERING COMMITTEE" 3.1
"JSC CHAIRPERSON" 3.1.2
"LOSSES" 9.5.1
"NON-BANKRUPT PARTY" 8.2.2
"PATENT EXPENSES" 6.3.7
"PROSECUTING PARTY" 6.3.5
</TABLE>
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<TABLE>
<S> <C>
"SECONDARY ENFORCEMENT RIGHTS PARTY" 6.4.3
"SPC" 6.8
"STANFORD AGREEMENT" 4.5
"THIRD PARTY COLLABORATION" 2.6.2
"THIRD PARTY PERFORMERS" 2.6
</TABLE>
ARTICLE 2
COLLABORATION
2.1 OVERVIEW. The Parties shall collaborate in carrying out
the
Collaboration with the objective of Discovering and Developing
RNAi
Therapeutics directed to JCV in the Field for further
Commercialization by Biogen Idec. Alnylam shall be responsible
for the
Discovery of such RNAi Therapeutics, and will present Biogen
Idec with
up to [**] RNAi Therapeutics directed to JCV that meet the
Development
Criteria and from which Biogen Idec shall select [**] for
further
Development under the Collaboration. Subject to the terms of
this
Agreement, Biogen Idec will be responsible for the Development
of [**]
Selected RNAi Therapeutics and for the further Commercialization
of
such Selected RNAi Therapeutics. The Discovery of such RNAi
Therapeutics and the Development of the Selected RNAi
Therapeutics
shall be governed by the Annual Work Plan, and the Parties agree
to
conduct all their Discovery and Development activities in
accordance
with the Annual Work Plan. For the avoidance of doubt, Biogen
Idec
shall have the right to Develop and Commercialize [**], but
shall have
no obligation to Develop and Commercialize [**].
2.2 DISCOVERY PROGRAM. During the Discovery Term, Alnylam shall
use
Commercially Reasonable Efforts to Discover [**] RNAi
Therapeutics
directed to JCV that meet the Development Criteria agreed upon
by the
JSC and included in the Annual Work Plan (the "Discovery
Program").
Alnylam shall from time to time notify the JSC in writing that
it
believes that a particular RNAi Therapeutic directed to JCV
Discovered
by Alnylam meets the Development Criteria. Upon such notice, the
JSC
will promptly meet and Alnylam shall provide the JSC with the
data and
information in its possession and Control regarding the
applicable
RNAi Therapeutic. Alnylam shall present Biogen Idec with [**]
RNAi
Therapeutics in accordance with this Section 2.2. Biogen Idec
shall
have the right to select [**] RNAi Therapeutics presented by
Alnylam
by written notice to Alnylam. Biogen Idec may make its selection
[**]
at any time after Alnylam's presentation of the first RNAi
Therapeutic
to the JSC, but Biogen Idec must identify [**] no later than
[**] days
after Alnylam's presentation of [**] to the JSC. For avoidance
of
doubt, if Biogen Idec selects [**] prior to Alnylam's
presentation of
[**] to the JSC, Alnylam will not be relieved of its obligation
to
present [**] to the JSC. In the event that Biogen Idec wishes to
[**],
Biogen Idec shall do so by written notice to Alnylam no later
than
[**] days after Alnylam's presentation to the JSC of [**].
2.3 DEVELOPMENT PROGRAM. Each Party shall use Commercially
Reasonable
Efforts to fulfill its obligations to Develop at least one
Selected
RNAi Therapeutic as set forth in the Annual Work Plan. Except
as
otherwise agreed by the JSC in writing, all activities
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relating to the Development of each Selected RNAi Therapeutic
(the
"Development Program") will be set forth in the Annual Work
Plan.
2.4 ANNUAL WORK PLAN. The Parties shall prepare and submit for
approval by
the JSC the Annual Work Plan for every Contract Year at least
[**]
days prior to the commencement of such Contract Year or, in the
case
of the first Contract Year only, within [**] days after the
Effective
Date. The first Annual Work Plan shall be based on and
consistent with
the draft Annual Work Plan attached as Schedule 1.8. The JSC
shall
update and amend, as appropriate, the then-current Annual Work
Plan
from time to time. All such updates or amendments shall be
subject to
approval of the JSC. Each Annual Work Plan shall contain the
specific
objectives to be achieved during the Contract Year, the
specific
activities to be performed under the Discovery Program and
the
Development Program, the timeline for performing such activities
and
the Development Criteria. The Annual Work Plan shall
allocate
Development tasks between the Parties consistent with their
respective
capabilities and with the respective responsibilities of the
Parties
as set forth in Sections 2.9 and 2.10 below, and to the
extent
possible and scientifically sound, in a manner to maximize
the
expeditious and cost-effective Development and Manufacture of
each
Selected RNAi Therapeutic. Each Annual Work Plan shall be
accompanied
by a budget prepared by the JSC setting forth the projected
internal
and external resources and expenses for the Discovery Program
and the
Development Program, including quarterly cost detail for the
upcoming
calendar year, quarterly forecast of Net Sales, if applicable,
for the
upcoming calendar year, and the number of Alnylam FTE's expected
to be
required. In addition, the JSC shall approve a long-range
budget
covering activities anticipated under Annual Work Plans for each
of
the subsequent [**] years. In recognition of the importance
of
budgets, each Party shall have the full opportunity to review
and
comment on budgets before final approval. The JSC will update
the
budget as necessary to reflect approved changes in the
Parties'
activities or changes in expected costs for those activities.
Such
budget shall be reviewed and approved at least annually by the
JSC
pursuant to Section 3.1.4(c).
2.5 [**]. Biogen Idec may at any time, by written notice to the
JSC, elect
to [**] the JCV RNAi Therapeutic, and the Parties shall
promptly
develop a revised Annual Work Plan to be approved by the
JSC.
Effective upon such notice (a) all references in this Agreement
to
[**] will automatically be deemed to refer to [**], and (b)
all
references to [**] will be deemed to refer to [**].
2.6 THIRD PARTIES.
2.6.1 In General. The Parties shall be entitled to utilize
the
services of Third Parties, including Third Party contract
research organizations and service providers, and to
collaborate
with Third Parties ("Third Party Performers"), to perform
their
respective Discovery, Development and Manufacturing
activities;
provided that each Party shall remain at all times fully
liable
for its respective responsibilities under this Agreement and
the
Annual Work Plan. Except as expressly permitted under
Section
2.6.2, neither Party shall use Third Party Performers to
conduct
part or all of its obligations under this Agreement or the
Collaboration unless the contracting or collaborating
party's
agreement with the Third Party Performer
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provides the non-contracting or non-collaborating Party with
the
same rights under this Agreement as if the contracting or
collaborating Party had done the work itself, and any such
Third
Party agreement shall include confidentiality and non-use
provisions which are no less stringent than those set forth
in
Article 7 of this Agreement.
2.6.2 Third Party Collaborations. In the event that, despite
good
faith efforts, the contracting Party is unable to enter into
an
agreement with a Third Party Performer that meets the
requirements of the second sentence of Section 2.6.1, such
activities will be termed a "Third Party Collaboration." If
any
Third Party Collaborations are contemplated in connection
with
the Collaboration, such Third Party Collaborations will be
approved in advance by the JSC, and the Annual Work Plan shall
be
amended to include such approved Third Party Collaborations.
The
Parties shall use good faith efforts to ensure that, to the
extent possible, all such Third Party Collaborations shall
provide that any and all data and results, discoveries and
inventions, whether patentable or not, arising out of the
Third
Party Collaboration may be used by bona fide collaborators of
the
Party entering into the Third Party Collaboration agreement.
In
addition, a Party entering into any such Third Party
Collaboration shall use reasonable efforts to obtain a right
to
sublicense to the other Party and its Affiliates and
Sublicensees
any intellectual property arising out of the Third Party
Collaboration to the extent necessary for the other Party to
perform its obligations under this Agreement. Except as
expressly
stated in this Section 2.6.2, all Third Party Collaborations
must
meet the requirements of Section 2.6.1.
2.7 RECORDS. Each Party shall maintain scientific records, in
sufficient
detail and in good scientific manner appropriate for patent
and
regulatory purposes, which shall fully and properly reflect all
work
done and results achieved in the performance of the
Collaboration by
such Party. Each Party shall have the right, during normal
business
hours and upon reasonable notice, to inspect and copy (or
request the
other Party to copy) all records of the other Party maintained
in
connection with the work done and results achieved in the
performance
of the Collaboration, but solely to the extent access to such
records
is necessary for a Party to exercise its rights under this
Agreement.
All such records and the information disclosed therein shall
be
maintained in confidence by the recipient in accordance with
Article
7.
2.8 DEVELOPMENT MATERIAL TRANSFER. In order to facilitate
the
Collaboration, either Party may provide to the other Party
certain
Development Materials Controlled by the supplying Party (other
than
under this Agreement) for use by the other Party in furtherance
of the
Collaboration. Except as otherwise provided under this Agreement
or
explicitly authorized in writing by the supplying Party, all
such
Development Materials delivered to the other Party shall remain
the
sole property of the supplying Party, shall be used only in
furtherance of the Collaboration and solely under the control of
the
other Party and its Affiliates, shall not be used or delivered
to or
for the benefit of any Third Party without the prior written
consent
of the supplying Party, and shall not be used in research or
testing
involving human subjects. The Development Materials supplied
under
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this Section 2.8 must be used with prudence and appropriate
caution in
any experimental work, since not all of their characteristics
may be
known. THE DEVELOPMENT MATERIALS ARE PROVIDED "AS IS" AND
WITHOUT ANY
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING
WITHOUT
LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS
FOR
ANY PARTICULAR PURPOSE OR, SAVE AS EXPLICITLY PROVIDED IN
THIS
AGREEMENT, ANY WARRANTY THAT THE USE OF THE MATERIALS WILL
NOT
INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF
ANY
THIRD PARTY.
2.9 REGULATORY MATTERS.
2.9.1 Coordination. Biogen Idec shall oversee, monitor,
coordinate,
file and hold in its name all regulatory actions,
communications
and filings with and submissions, including filings and
submissions of supplements and amendments thereto, to the
applicable Regulatory Authorities with respect to the
Selected
RNAi Therapeutics; provided, however, that Biogen Idec shall
consult with Alnylam regarding [**].
2.9.2 Regulatory Meetings and Correspondence. Biogen Idec shall
be
responsible for interfacing, corresponding and meeting with
the
applicable Regulatory Authorities with respect to the
Selected
RNAi Therapeutics. Upon the request of Biogen Idec, Alnylam
shall
[**] the applicable Regulatory Authorities with respect to
each
Selected RNAi Therapeutic.
2.9.3 Review of Correspondence. To the extent practicable,
Biogen Idec
shall provide Alnylam with [**] the applicable Regulatory
Authorities pertaining to each Selected RNAi Therapeutic,
[**],
and, [**] Biogen Idec, Alnylam shall [**]. Biogen Idec shall
provide to Alnylam as soon as reasonably practicable [**]
such
Regulatory Authorities pertaining to each Selected RNAi
Therapeutic (including without limitation [**]).
2.9.4 Assistance. Each Party shall cooperate with the other
Party to
provide all reasonable assistance and take all actions
reasonably
requested by the other Party that are necessary or desirable
to
enable the other Party to comply with any law or regulation
applicable to the Selected RNAi Therapeutics or the
Collaboration, including, but not limited to, reporting
adverse
drug experiences (and serious adverse drug experiences) to
the
applicable Regulatory Authorities.
2.10 MANUFACTURE AND SUPPLY.
2.10.1 Pre-Clinical and Clinical Supply. During the
Collaboration
Term, Alnylam will use Commercially Reasonable Efforts to
Manufacture and supply the Parties' requirements of the
Selected
RNAi Therapeutics for pre-clinical and clinical Discovery
and
Development purposes, including those requirements for
manufacture and supply of Selected RNAi Therapeutics for
administration outside of formal clinical trials in the
manner
described in Section 1.38(a). Biogen Idec
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will pay Alnylam for the quantities of Selected RNAi
Therapeutics
supplied by Alnylam hereunder in accordance with Section
5.1.2.
Within [**] after the Effective Date, the Parties shall
enter
into a supply agreement reasonably acceptable to both
Parties
pursuant to which Alnylam will supply the Selected RNAi
Therapeutics to Biogen Idec. The aforementioned supply
agreement
shall provide that (a) [**] Manufacturing each Selected RNAi
Therapeutic [**]; (b) any such [**] will be subject to [**];
and
(c) Biogen Idec shall [**] Selected RNAi Therapeutics for
pre-clinical and clinical Discovery and Development. Such
supply
agreement will also explicitly provide that [**].
2.10.2 Commercial Supply. Biogen Idec shall be responsible for
the
Manufacture and supply of the Selected RNAi Therapeutics
after
the Collaboration Term and for commercial sale throughout
the
Territory. Alnylam shall provide [**]; provided that (a) any
such
[**]; and (b) [**] of Alnylam.
2.11 COMMERCIALIZATION. Subject to the terms of this Agreement,
Biogen Idec
shall be solely responsible for all Commercialization
activities
relating to the Selected RNAi Therapeutics and shall bear one
hundred
percent (100%) of all expenses for the Commercialization of
such
Selected RNAi Therapeutics. Biogen Idec shall use
Commercially
Reasonable Efforts to Commercialize the JCV RNAi Therapeutic in
the
Major Markets.
ARTICLE 3
COLLABORATION MANAGEMENT
3.1 JOINT STEERING COMMITTEE. As soon as practicable after the
Effective
Date, the Parties shall establish a committee to facilitate
the
Collaboration (the "Joint Steering Committee" or "JSC") as
follows:
3.1.1 Composition of the JSC. The Collaboration shall be
conducted
under the direction of a JSC comprised of three (3)
representatives of Alnylam and three (3) representatives of
Biogen Idec. Each Party shall appoint its respective
representatives to the JSC from time to time, and may
substitute
one or more of its representatives, in its sole discretion,
effective upon notice to the other Party of such change.
Each
Party shall have at least one JSC representative who is a
senior
employee (director level or above), and all JSC
representatives
shall have appropriate research, preclinical, manufacturing,
clinical development or commercialization expertise and
ongoing
familiarity with the Collaboration. Additional representatives
or
consultants may from time to time, by mutual consent of the
Parties, be invited to attend JSC meetings, subject to such
representatives' and consultants' written agreement to
comply
with the requirements of Article 7. Each Party shall bear its
own
expenses relating to attendance at such meetings by its
representatives.
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3.1.2 JSC Chairperson. The "JSC Chairperson" shall be a
representative
of Biogen Idec. The JSC Chairperson's responsibilities shall
include (a) scheduling meetings at least once per Contract
Quarter, but more frequently if the JSC determines it
necessary;
(b) setting agendas for meetings with solicited input from
other
members; (c) confirming and delivering minutes to the JSC
for
review and final approval; and (d) conducting effective
meetings,
including ensuring that objectives for each meeting are set
and
achieved.
3.1.3 Meetings. The JSC shall meet in accordance with a
schedule
established by mutual written agreement of the Parties, but
no
less frequently than once per Contract Quarter, with the
location
for such meetings alternating between Alnylam and Biogen
Idec
facilities (or such other locations as are determined by the
JSC). Alternatively, the JSC may meet by means of
teleconference,
videoconference or other similar communications equipment, but
at
least two meetings per year shall be conducted in person.
3.1.4 JSC Responsibilities. The JSC shall have the following
responsibilities with respect to the Collaboration:
(a) determining the overall Discovery and Development
strategy
for each Selected RNAi Therapeutic in the Territory;
(b) reviewing for approval the initial Annual Work Plan
(including without limitation the Development Criteria)
within [**] days after the Effective Date, with appropriate
input from Alnylam and Biogen Idec senior management;
(c) reviewing for approval (i) the annual update to the
Annual
Work Plan and the related budget described in Section 2.4,
and (ii) any modifications to such Annual Work Plan and
related budget, in each case within [**] days of each
submission to the JSC;
(d) determining each Party's responsibilities under the
Annual
Work Plan consistent with Section 2.4; provided, however,
that the JSC may not, without Alnylam's consent, assign
Alnylam any responsibilities under the Annual Work Plan for
which Alnylam does not at the time already have sufficient
internal expertise and resources;
(e) facilitating the transfer of Know-How and Confidential
Information between the Parties for purposes of conducting
the Annual Work Plan;
(f) regularly assessing the progress of the Parties in their
conduct of the Annual Work Plan and against the timelines
and budgets contained therein, reviewing relevant data, and
considering issues of priority;
(g) reviewing for approval, within the Parties' regular
business
cycles, but no later than [**] days after a proposal is made
to the JSC by either Party, the
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initiation of IND-Enabling Toxicology Studies and the
submission of an IND with respect to each Selected RNAi
Therapeutic; and
(h) performing such other activities as are contemplated
under
this Agreement and that the Parties mutually agree shall be
the responsibility of the JSC.
3.2 APPOINTMENT OF SUBCOMMITTEES, PROJECT TEAMS AND
COLLABORATION
MANAGERS. The JSC shall be empowered to create such
subcommittees of
itself and additional project teams as it may deem appropriate
or
necessary. Each such subcommittee and project team shall report
to the
JSC, which shall have authority to approve or reject
recommendations
or actions proposed thereby subject to the terms of this
Agreement.
Each Party shall also designate a "Collaboration Manager."
The
Collaboration Managers will be responsible for the
day-to-day
coordination of the Collaboration and will serve to
facilitate
communication between the Parties. Each Party may change its
designated Collaboration Manager from time to time upon written
notice
to the other Party.
3.3 REPORTS AND MINUTES. Each Party will provide the members of
the JSC
with written copies of all materials they intend to present at
the JSC
meeting. The JSC may also request at any time specific data
or
information related to Development activities or that a written
report
be prepared in advance of any meeting summarizing certain
material
data and information arising out of the conduct of the
Development
activities and the Party or appropriate committee to whom such
request
is made shall promptly provide to the other Party or JSC such
report,
data or information. A secretary shall be appointed for each
meeting
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 the JSC.
3.4 DECISION-MAKING AND DISPUTE RESOLUTION.
3.4.1 Voting. With respect to decisions of the JSC, the
representatives of each Party shall have collectively one vote
on
behalf of such Party. For each meeting of the JSC, at least
two
(2) representatives of each Party shall constitute a quorum.
Action on any matter may be taken at a meeting, by
teleconference, videoconference or by written agreement.
3.4.2 Decision-Making. The JSC shall operate by consensus,
subject to
the dispute resolution process set forth in Section 3.4.3
below.
3.4.3 Dispute Resolution. The JSC shall attempt to resolve any
and all
disputes relating to the Collaboration by unanimous consensus.
In
the event the JSC is unable to reach a unanimous consensus
with
respect to any such dispute, then the following dispute
resolution provisions shall apply.
(a) With respect to any dispute over which [**] except those
disputes related to [**]; provided, however, that [**] shall
have the right to propose [**], for good faith consideration
by [**], and if [**], then [**] shall [**]. Notwithstanding
anything to the contrary, [**] may not, without
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Alnylam's consent, increase Alnylam's obligation to provide
FTE's in performance of Alnylam's activities under the
Annual Work Plan by more than [**] percent ([**]%) of the
number of FTE's required in the preceding year.
(b) Notwithstanding anything else contained herein,
Commercialization activities shall not be the responsibility
of the JSC and shall be subject to Biogen Idec's final
decision-making authority.
(c) With respect to any dispute concerning [**] the dispute
shall be [**] as described in this paragraph. If the dispute
cannot be resolved [**], then within [**] days after
[**]shall be [**] in good faith as soon as is practicable
but in no event [**]. Such resolution, if any, by [**] shall
be final and binding on the Parties. If the [**] shall have
[**] decision-making authority.
(d) With respect to all other disputes between the Parties
regarding the interpretation, construction or application of
this Agreement, the dispute shall be [**] for review as
described in this paragraph. If the dispute cannot be
resolved [**], then within [**] days after [**] shall be
[**] as soon as is practicable but in no event [**]. Such
resolution, if any, by [**] shall be final and binding on
the Parties. If the [**], each Party will be free to pursue
all rights available to it under law or equity.
3.5 DISSOLUTION OF JSC. The JSC shall be dissolved at the end of
the
Collaboration Term; provided that Alnylam's participation in the
JSC
after the fifth (5th) anniversary of the Effective Date will be
at
Alnylam's sole option.
ARTICLE 4
LICENSES
4.1 LICENSE GRANTS. The following Licenses are granted as of the
Effective
Date:
4.1.1 Discovery License. Subject to the terms and conditions of
this
Agreement, Biogen Idec hereby grants Alnylam a co-exclusive
(with
Biogen Idec) royalty-free license under Biogen Idec Technology
to
Discover RNAi Therapeutics directed to JCV and to otherwise
conduct the Discovery Program in the Field, in each case to
the
extent necessary for Alnylam to conduct its activities under
the
Annual Work Plan. Subject to the terms and conditions of
this
Agreement, Alnylam hereby grants Biogen Idec a co-exclusive
(with
Alnylam), royalty-free license under Alnylam Technology to
Discover RNAi Therapeutics directed to JCV and to otherwise
conduct the Discovery Program in the Field, in each case to
the
extent necessary for Biogen Idec to conduct its activities
under
the Annual Work Plan.
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4.1.2 Development Licenses. Subject to the terms and conditions
of
this Agreement, Alnylam hereby grants Biogen Idec a
co-exclusive
(with Alnylam), royalty-free license under Alnylam Technology
to
Develop the Selected RNAi Therapeutics in the Field in the
Territory, to the extent necessary for Biogen Idec to conduct
its
activities under the Annual Work Plan. Subject to the terms
and
conditions of this Agreement, Biogen Idec hereby grants Alnylam
a
co-exclusive (with Biogen Idec), royalty-free license under
Biogen Idec Technology to Develop the Selected RNAi
Therapeutics
in the Field in the Territory, to the extent necessary for
Alnylam to conduct its activities under the Annual Work
Plan.
4.1.3 Commercialization License. Subject to the terms and
conditions
of this Agreement, Alnylam hereby grants Biogen Idec an
exclusive, royalty-bearing license under Alnylam Technology
to
Commercialize the Selected RNAi Therapeutics in the Field in
the
Territory.
4.1.4 Manufacturing Licenses. Subject to the terms and
conditions of
this Agreement, only as permitted and solely for the purposes
set
forth in Section 2.10.2, Alnylam hereby grants Biogen Idec a
non-exclusive, fully-paid, royalty-free license under
Alnylam
Technology to Manufacture the Selected RNAi Therapeutics for
the
Territory. Subject to the terms and conditions of this
Agreement,
only as permitted and solely for the purposes set forth in
Section 2.10.1, Biogen Idec hereby grants Alnylam a
non-exclusive
license under Biogen Idec Technology to Manufacture the
Selected
RNAi Therapeutics.
4.1.5 Blocking RNAi Technology License. Biogen Idec hereby
grants
Alnylam a non-exclusive, royalty-free license, with the right
to
grant sublicenses, under any Blocking RNAi Technology for
the
purpose of research, development, manufacture, use, import,
distribution, marketing or sale of RNAi Therapeutics outside
the
Field.
4.2 SUBLICENSES AND LICENSES OF JOINT COLLABORATION IP. The
licenses in
Section 4.1 each includes the right to grant sublicenses and
licenses
as provided in this Section 4.2 below.
4.2.1 Affiliates. Each Party shall be entitled to grant
sublicenses of
its rights under this Agreement (and licenses under any
Joint
Collaboration IP) to any of its Affiliates for so long as
such
entity remains an Affiliate.
4.2.2 Academic Collaborators and Service Companies. Each Party
shall
be entitled to grant sublicenses of its rights under
Sections
4.1.1 and 4.1.2 (and licenses under any Joint Collaboration
IP)
in connection with its activities under the Annual Work Plan
to
academic collaborators, and contract service organizations,
that
in each case are subject to and fulfill the requirements of
Section 2.6, to perform its obligations under such Annual
Work
Plan.
4.2.3 Manufacturing Sublicenses. Subject to the provisions of
Sections
2.10.1 and 2.10.2 regarding approval of subcontractors, each
Party entitled to Manufacture RNAi Therapeutics under the
terms
and conditions of this Agreement shall be
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entitled to grant sublicenses of its rights under this
Agreement
(and licenses under any Joint Collaboration IP) to Third
Parties
to Manufacture such RNAi Therapeutics; provided, that such
Party
shall remain primarily responsible with respect to such
sublicense.
4.2.4 Terms. Each sublicense granted by a Party pursuant to
Section
4.2.2 or Section 4.2.3 shall be subject and subordinate to
the
terms and conditions of this Agreement and shall contain
terms
and conditions consistent with those in this Agreement.
Agreements with any Commercializing Sublicensee shall contain
the
following provisions: (a) a requirement that such
Sublicensee
submit applicable sales or other reports consistent with
those
required hereunder; (b) an audit requirement similar to the
requirement set forth in Section 5.5; and (c) a requirement
that
such Sublicensee comply with the confidentiality and non-use
provisions of Article 7 with respect to both Parties'
Confidential Information.
4.2.5 Liability. Each Party shall at all times be responsible
for the
performance of its Sublicensees under this Agreement.
4.2.6 Sublicense Survival. Any sublicense by a Party shall be
subject
to the provisions of this Agreement and shall survive
termination
of the licenses or other rights granted to such Party under
this
Agreement in accordance with this Section 4 and be assumed by
the
other Party as long as (a) the Sublicensee is not then in
breach
of its sublicense agreement, (b) the Sublicensee agrees in
writing to be bound to the non-sublicensing Party as a
licensor
under the terms and conditions of the sublicense agreement,
and
(iii) the Sublicensee agrees in writing that in no event
shall
the non-sublicensing Party assume any obligations or
liabilities,
or be under any obligation or requirement of performance,
under
any such sublicense extending beyond such Party's obligations
and
liabilities under this Agreement.
4.3 JOINT COLLABORATION IP. Subject to the rights granted each
Party under
this Agreement, each Party shall have the right to use, sell,
keep,
license or assign its interest in Joint Collaboration IP and
otherwise
undertake all activities a sole owner might undertake with
respect to
such Joint Collaboration IP without the consent of and
without
accounting to the other Party.
4.4 IN-LICENSES. All licenses and other rights granted Biogen
Idec under
this Article 4 are subject to the rights and obligations of
Alnylam
under the Alnylam In-Licenses. All licenses and other rights
granted
Alnylam under this Article 4 are subject to the rights and
obligations
of Biogen Idec under the Biogen Idec In-Licenses.
4.5 CERTAIN PATENT RIGHTS. Notwithstanding anything to the
contrary
herein, the licenses to Alnylam Patent Rights hereunder
initially
shall not include licenses to Patent Rights licensed by Alnylam
or its
Affiliates under the [**]; provided that if any such Patent
Rights
in-licensed by Alnylam become issued Patent Rights that Cover
a
Selected RNAi Therapeutic, Alnylam shall so notify Biogen Idec
in
writing, and Biogen Idec shall have the option of expanding
its
licenses to Alnylam Patent Rights hereunder to include such
issued
Patent Rights by notifying Alnylam of such election in writing.
Upon
such
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election, the [**] Agreement shall be deemed an Existing
Alnylam
In-License and Schedule 1.41 shall be amended accordingly
without any
further consideration due from Biogen Idec to Alnylam.
Further,
notwithstanding anything to the contrary herein, the licenses
to
Alnylam Patent Rights hereunder shall not include licenses to
Patent
Rights licensed by Alnylam or its Affiliates under the
License
Agreement between [**]. The Parties shall simultaneously with
the
execution of this Agreement enter into an agreement
substantially in
the form set forth in Schedule 4.5 (the "[**] Sublicense
Agreement").
4.6 TERMINATION OF CERTAIN LICENSE RIGHTS. Notwithstanding
anything to the
contrary in this Agreement, in the event that Biogen Idec
imposes any
conditions of access to or treatment with Selected RNAi
Therapeutic by
patients who have been treated using products from Third Parties
that
compete directly with Linked Products, then all rights and
licenses
granted to Biogen Idec with respect to [**], whichever is
less
advanced in the Development and Commercialization process,
shall
terminate and revert to Alnylam.
4.7 NO OTHER RIGHTS. Except as otherwise expressly provided in
this
Agreement, under no circumstances shall a Party hereto, as a
result of
this Agreement, obtain any ownership interest or other right in
any
Know-How or Patent 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.
ARTICLE 5
FINANCIAL PROVISIONS
5.1 DISCOVERY, DEVELOPMENT AND MANUFACTURING FUNDING.
5.1.1 Discovery and Development Funding. Biogen Idec will
reimburse
Alnylam for all internal and out-of-pocket costs and
expenses
incurred by Alnylam during the Collaboration Term in
accordance
with the Annual Work Plan, for [**]. The costs of Alnylam's
internal personnel engaged in such efforts shall be determined
by
multiplying the number of full time equivalent person years
("FTEs") allocated by Alnylam to the Collaboration during
the
relevant time period, by the FTE Rate. The "FTE Rate" for
work
performed by Alnylam FTEs will be $[**] per FTE, which amount
may
be increased or decreased on an annual basis as mutually
agreed
by the Parties, but in no event more than [**] percent
([**]%)
per Contract Year.
5.1.2 Manufacturing Funding. Biogen Idec will pay Alnylam [**]
for
quantities of each Selected RNAi Therapeutic supplied by
Alnylam
to Biogen Idec pursuant to Section 2.10.1 that is equal to
[**]
as set forth in [**].
5.2 MILESTONES.
5.2.1 Upfront Payment. No later than ten (10) Business Days
after the
Effective Date, Biogen Idec wi
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