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.
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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 000 Xxxxx Xxxxxx, Xxxxx Xxxxx, Xxxxxxxxx,
Xxxxxxxxxxxxx 00000 ("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 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, XX 00000 ("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 xxxx(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:
TERM SECTION
---- -------
"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
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"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
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 will pay to Alnylam Five Million U.S.
Dollars (U.S. $5,000,000), of
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which [**] U.S. Dollars ($[**]) will be allocated to the payment
required under Section 3.1 of the [**] Sublicense Agreement.
5.2.2 Other Milestones. Biogen Idec will also pay to Alnylam the
amounts set forth below no later than [**] days after the
earliest date on which the corresponding milestone event has
first been achieved with respect to a Selected RNAi Therapeutic.
For clarity, in the event that a milestone event that was already
achieved with respect to the Development Candidate is achieved
with respect to the Back-Up Candidate, or vice versa, then no
additional milestone payment shall be due with respect to the
second achievement of the applicable milestone event.
Payment
Milestone Event (in U.S. Dollars)
--------------- -----------------
Initiation of IND-Enabling GLP
Toxicology Studies $[**]
Upon the first IND becoming an
Active IND $[**]
Clinical Proof of Concept $[**]
Established Utilization or
Regulatory Approval, whichever
occurs first, in the first Major
Market(1) $[**]
Established Utilization or
Regulatory Approval, whichever
occurs first, in the second Major
Market(1)* $[**]
Treatment of the 100th patient $[**]
(1) For purposes of determining achievement of these milestones only,
Established Utilization shall be determined on a Major Market by Major
Market basis (for example, for such purpose, the number of patients
referred to in clause (a) of Section 1.38 shall be determined based on the
number of such patients in a particular Major Market).
5.3 ROYALTIES. Commencing upon the date of the first achievement of
Established Utilization anywhere in the Territory (the "Established
Utilization Date"), Biogen Idec will also pay to Alnylam an amount
equal to the greater of (a) the royalties calculated in accordance
with Section 5.3.1, and (b) the annual royalty calculated in
accordance with Section 5.3.2:
5.3.1 Royalties equal to the following percentage of the combined
total of annual worldwide Net Sales of the Selected RNAi
Therapeutics:
----------
* If Established Utilization or Regulatory Approval in the first Major Market
occurs in any of the United Kingdom, France, Germany, Italy or Spain, this
milestone shall only be due if this milestone is subsequently met for the
European Union, United States or Japan.
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On the portion of the combined total of annual
worldwide Net Sales of the Selected RNAi
Therapeutics that is: Royalty Rate
---------------------------------------------- -------------
Less than $[**] [**]%
From $[**] to $[**] [**]%
Greater than $[**] [**]%
5.3.2 An annual royalty comprising (a) a Fixed Annual Royalty for the
Established Utilization Year in question as specified below, plus
(b) for every patient treated with a Selected RNAi Therapeutic
during such year, a fee of [**] U.S. Dollars ($[**]), up to an
aggregate amount equal to the yearly Treatment Cap outlined
below:
Period Fixed Annual Royalty Treatment Cap
------ -------------------- -------------
Established Utilization Year 1 $[**] $[**]
Established Utilization Year 2 $[**] $[**]
Established Utilization Year 3 $[**] $[**]
Established Utilization Year 4
and beyond $[**] $[**]
5.4 PAYMENTS; REPORTS.
5.4.1 Fixed Annual Royalties/Treatment Reports and Payments. Within
[**] days after the beginning of each Established Utilization
Year, Biogen Idec will pay to Alnylam the Fixed Annual Royalty
set forth in Section 5.3.2. Biogen Idec shall also, within [**]
days after the end of each Established Utilization Quarter,
submit to Alnylam a report stating the number of patients treated
with each Selected RNAi Therapeutic, other than those treated in
the context of a registrational trial, during such Established
Utilization Quarter. Concurrently with such report, Biogen Idec
shall pay to Alnylam the amounts due for each such patient as set
forth in Section 5.3.2.
5.4.2 Royalty Reports and Payments. Within [**] days after the end of
each Established Utilization Year, Biogen Idec will provide to
Alnylam a report, on a country-by-country basis, providing in
reasonable detail an accounting of all Net Sales of the Selected
RNAi Therapeutics made during such Established Utilization Year
and the calculation of the applicable royalty under Section
5.3.1. If such royalty report shows that the amount of royalties
due for such Established Utilization Year exceeds the amounts
paid by Biogen Idec to Alnylam in accordance with Section 5.4.1
then, concurrently with such report, Biogen Idec
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shall pay to Alnylam the difference between the amounts paid
pursuant to Section 5.4.1 and the royalties due under Section
5.3.1 for the applicable Established Utilization Year. If there
is an Established Utilization Year where Biogen Idec is required
to make a payment to Alnylam in accordance with the immediately
preceding sentence then, commencing with the Established
Utilization Year immediately following such Established
Utilization Year, (a) Biogen Idec shall be required to provide to
Alnylam the royalty reports required under this Section 5.4.2
within [**] days after the end of each Established Utilization
Quarter during each succeeding Established Utilization Year; and
(b) if any such report shows that the cumulative royalties due
for such Established Utilization Year exceed the cumulative
payments made during that Established Utilization Year under
Section 5.4.1 then, concurrently with such report, Biogen Idec
shall pay to Alnylam the difference between the amounts paid to
date during such Established Utilization Year pursuant to Section
5.4.1 and the royalties due under Section 5.3.1 to date for the
applicable Established Utilization Year.
5.4.3 Payment Term. The payments required under Section 5.3 shall be
effective as of the Established Utilization Date, and shall
continue on a Selected RNAi Therapeutic-by-Selected RNAi
Therapeutic basis until the later of (a) the expiration of the
last Valid Claim of any Alnylam Patent Rights covering the
Manufacture or Commercialization of a Selected RNAi Therapeutic
in the Territory, or (b) the [**] anniversary of the Established
Utilization Date or Regulatory Approval, whichever comes first;
provided, however, that (i) only one royalty shall be due under
Section 5.3.1 with respect to the same unit of Selected RNAi
Therapeutic, and (ii) no royalties shall be due under Section
5.3.1 upon the sale or other transfer among Biogen Idec or its
Related Parties, but in such cases the royalty shall be due and
calculated upon Biogen Idec's or its Related Party's Net Sales to
the first independent Third Party.
5.4.4 Blended Royalty Rates. The Parties acknowledge and agree that
the Patent Rights and Know-How licensed pursuant to this
Agreement justify royalty rates of differing amounts with respect
to the sales of each Selected RNAi Therapeutic, which rates could
be applied separately to each Selected RNAi Therapeutic involving
the exercise of such Patent Rights and/or the incorporation of
such Know-How, and that, if such royalties were calculated
separately, royalties relating to Patent Rights and royalties
relating to Know-How would last for different terms.
Notwithstanding the foregoing, the Parties have determined, for
reasons of convenience, that blended royalty rates for the Patent
Rights and the Know-How licensed hereunder, as set forth above,
will apply during a single payment term. The Parties acknowledge
and agree that nothing in this Agreement (including without
limitation any exhibits or attachments hereto) shall be construed
as representing an estimate or projection of the anticipated
sales or the actual value of any Selected RNAi Therapeutic, and
that the figures set forth in this Section 5.4 or elsewhere in
this Agreement or that have otherwise been discussed by the
Parties are merely intended to define the Parties' royalty
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payment obligations to each other in the event such sales
performance is achieved.
5.4.5 Royalties under [**] Sublicense Agreement. For avoidance of
doubt, the royalties payable by Biogen Idec under this Agreement
include any royalties due under the [**] Sublicense Agreement,
and no additional payment will be due from Biogen Idec for such
royalties.
5.5 AUDITS. Each Party shall keep complete and accurate records of the
underlying revenue, expense and other data relating to the reports and
payments required by this Article 5. Each Party will have the right
once annually at its own expense to have an independent, certified
public accountant, selected by such Party and reasonably acceptable to
the other Party, review any such records of the other Party in the
location(s) where such records are maintained by the other Party upon
reasonable notice and during regular business hours and under
obligations of strict confidence, for the sole purpose of verifying
the basis and accuracy of payments made under this Article 5, in each
case within the prior thirty-six (36) month period. If the review of
such records reveals that the other Party has failed to accurately
report information pursuant to this Article 5, then the other Party
shall promptly pay to the auditing Party any resulting amounts due
under this Article 5, together with interest calculated in the manner
provided in Section 5.8. If any amounts due under this Article 5 as a
result of such audit are greater than the lesser of $[**] or [**]
percent ([**]%) of the amounts actually due for a calendar year under
Article 5, as applicable, the other Party shall pay all of the costs
of such review. Each Party shall treat all financial information
subject to review under this Section 5.5 or under any sublicense
agreement in accordance with the confidentiality and non-use
provisions of this Agreement, and shall cause its accounting firm to
enter into an acceptable confidentiality agreement with the other
Party and/or its Affiliates and Sublicensees obligating it to retain
all such information in confidence pursuant to such confidentiality
agreement.
5.6 TAX MATTERS. If laws, rules or regulations require withholding of
income taxes or other taxes imposed upon payments set forth in this
Article 5, the paying Party shall make such withholding payments as
required and subtract such withholding payments from the payments set
forth in this Article 5. The paying Party shall submit appropriate
proof of payment of the withholding taxes to the receiving Party
within a reasonable period of time. At the request of the receiving
Party, the paying Party shall, at the receiving party's cost, give the
receiving Party such reasonable assistance, which shall include the
provision of appropriate certificates of such deductions made together
with other supporting documentation as may be required by the relevant
tax authority, to enable the receiving Party to claim exemption from
such withholding or other tax imposed or obtain a repayment thereof or
reduction thereof and shall upon request provide such additional
documentation from time to time as is reasonably required to confirm
the payment of tax.
5.7 PAYMENT AND CURRENCY EXCHANGE. All payments to be made under this
Agreement shall be made in United States dollars and shall be paid by
bank wire transfer in immediately available funds to such bank account
in the United States as may be designated in writing by the receiving
Party from time to time. In the case of Net Sales outside the United
States by Biogen Idec and its Related Parties, the rate of exchange to
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be used in computing the amount of currency equivalent in United
States dollars due shall be made at the rate of exchange utilized by
Biogen Idec in its worldwide accounting system.
5.8 LATE PAYMENTS. The paying Party shall pay interest to the receiving
Party on the aggregate amount of any payments that are not paid on or
before the date such payments are due under this Agreement at a rate
per annum equal to the lesser of the prime rate of interest plus [**]
percent ([**]%), as reported by The Wall Street Journal, or the
highest rate permitted by applicable law, calculated on the number of
days such payments are paid after the date such payments are due.
ARTICLE 6
INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS
6.1 INVENTORSHIP. Inventorship for patentable inventions conceived or
reduced to practice 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.
6.2 OWNERSHIP. 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 performing its obligations under this Agreement. Biogen
Idec 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 Biogen Idec or acquired solely by Biogen Idec in the
course of performing its obligations under this Agreement. The Parties
shall jointly own any inventions and discoveries (and Patent Rights
claiming patentable inventions therein) first made or discovered
jointly in the course of performing their obligations under this
Agreement.
6.3 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
6.3.1 Biogen Idec Technology. Biogen Idec has the sole responsibility
to, at Biogen Idec's discretion, file, conduct ex parte and inter
partes prosecution, and maintain (including the defense of any
interference or opposition proceedings) in the Territory, all
Patent Rights comprising Biogen Idec Technology (other than Joint
Collaboration IP), in Biogen Idec's name.
6.3.2 Alnylam Technology. Alnylam has the sole responsibility to, at
Alnylam's discretion, file, conduct ex parte and inter partes
prosecution, and maintain (including the defense of any
interference or opposition proceedings) in the Territory, all
Patent Rights comprising Alnylam Technology (other than Joint
Collaboration IP), in Alnylam's name; provided, however, that any
filing, prosecution and maintenance of any Core JCV Patents shall
be subject to Biogen Idec's continuing right to the prior review
of, comment on, revision to and
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approval of material documents, which shall not be unreasonably
delayed or withheld.
6.3.3 Joint Collaboration IP. Subject to Alnylam's continuing right to
the prior review of, comment on, revision to and approval of
material documents, which shall not be unreasonably delayed or
withheld, Biogen Idec has the sole responsibility to, at Biogen
Idec's discretion, file, conduct ex parte and inter partes
prosecution, and maintain (including the defense of any
interference or opposition proceedings) in the Territory, all
Patent Rights comprising Joint Collaboration IP (other than Broad
RNAi Technology Collaboration IP), in the names of both Alnylam
and Biogen Idec. Alnylam shall use Commercially Reasonable
Efforts to make available to Biogen Idec or its authorized
attorneys, agents or representatives, such of its employees as
Biogen Idec in its reasonable judgment deems necessary in order
to assist it in obtaining patent protection for such Joint
Collaboration IP. Alnylam shall sign, or use Commercially
Reasonable Efforts to have signed, all legal documents necessary
to file and prosecute patent applications or to obtain or
maintain patents in respect of such Joint Collaboration IP, at no
cost to Biogen Idec.
6.3.4 Broad RNAi Technology Collaboration IP. Notwithstanding Section
6.3.3, subject to Biogen Idec's continuing right to the prior
review of, comment on, revision to and approval of material
documents relating to Joint Collaboration IP, which shall not be
unreasonably delayed or withheld, Alnylam has the sole
responsibility to, at Alnylam's discretion, file, conduct ex
parte and inter partes prosecution, and maintain, including the
defense of any interference or opposition proceedings, in the
Territory, all Patent Rights comprising Broad RNAi Technology
Collaboration IP in the names of both Alnylam and Biogen Idec.
Biogen Idec shall use Commercially Reasonable Efforts to make
available to Alnylam or its authorized attorneys, agents or
representatives, such of its employees as Alnylam in its
reasonable judgment deems necessary in order to assist it in
obtaining patent protection for such Broad RNAi Technology
Collaboration IP. Biogen Idec shall sign or use Commercially
Reasonable Efforts to have signed all legal documents necessary
to file and prosecute patent applications or to obtain or
maintain patents in respect of such Broad RNAi Technology
Collaboration IP, at no cost to Alnylam.
6.3.5 Contingent Rights. The Party having the right to prosecute and
maintain patents under Sections 6.3.1, 6.3.2, 6.3.3 and 6.3.4
shall be referred to as the "Prosecuting Party". In the event the
Prosecuting Party elects not to seek or continue to seek or
maintain patent protection on any Alnylam Collaboration IP,
Biogen Idec Collaboration IP or Joint Collaboration IP which are
subject to the other Party's licensed rights under Article 4 in
the Territory, the other Party shall have the right (but not the
obligation), at its expense, to prosecute and maintain in any
country within the Territory patent protection on such Alnylam
Collaboration IP, Biogen Idec Collaboration IP or Joint
Collaboration IP in the name of Alnylam, Biogen Idec or both
Parties as set forth in Sections 6.3.1, 6.3.2, 6.3.3 and 6.3.4.
The
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previously Prosecuting Party shall use Commercially Reasonable
Efforts to make available to the other Party or its authorized
attorneys, agents or representatives, such of its employees as
are reasonably necessary to assist the other Party in obtaining
and maintaining the patent protection described under this
Section 6.3.5. The previously Prosecuting Party 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.
6.3.6 Cooperation. 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 as contemplated by
this Agreement; (b) to cooperate, if necessary and appropriate,
with the other Party in gaining patent term extensions wherever
applicable to Patent Rights that are subject to this; and (c) 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 that are
subject to this Agreement.
6.3.7 Patent Expenses. The patent filing, prosecution and maintenance
expenses incurred after the Effective Date with respect to Patent
Rights comprised of Alnylam Technology and Biogen Idec Technology
("Patent Expenses") shall be borne by each Party having the right
to file, prosecute and maintain such Patent Rights under this
Section 6.3.
6.4 THIRD PARTY INFRINGEMENT.
6.4.1 Notices. Each Party shall promptly report in writing to the
other Party during the Term any (a) known or suspected
infringement of any Alnylam Technology or Biogen Idec Technology
being used in the Collaboration, including without limitation any
Joint Collaboration IP, or (b) unauthorized use or
misappropriation of any Confidential Information by a Third Party
of which it becomes aware, and shall provide the other Party with
all available evidence supporting such infringement, or
unauthorized use or misappropriation.
6.4.2 Rights to Enforce.
(a) Biogen Idec's First Right. Subject to the provisions of
Section 6.4.2(b) and the provisions of any Third Party
agreement under which Biogen Idec's rights in Biogen Idec
Technology are granted or Alnylam's rights in Alnylam
Technology are granted and of any In-License, in respect of
the Selected RNAi Therapeutics in the Territory, Biogen Idec
shall have the sole and exclusive right to initiate an
infringement or other appropriate suit anywhere in the world
against any Third Party who at any time has infringed, or is
suspected of infringing, any Patent Rights, or of using
without proper authorization any Know-How, comprising in
each case (i) Biogen Idec Technology or the Core JCV
Patents, or (ii) Joint
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Collaboration IP Covering, claiming or relating to the
Selected RNAi Therapeutics. Alnylam will consider in good
faith any request from Biogen Idec to initiate an
infringement or other appropriate suit anywhere in the world
against any Third Party who at any time has infringed, or is
suspected of infringing, any Patent Rights, or of using
without proper authorization any Know-How, comprising
Alnylam Technology licensed to Biogen Idec under Section 4.1
other than the Core JCV Patents, but Alnylam shall not be
required to initiate any such suit.
(b) Alnylam's First Right. Alnylam shall have the sole and
exclusive right to initiate an infringement or other
appropriate suit anywhere in the world against any Third
Party who at any time has infringed, or is suspected of
infringing, any Patent Rights, or of using without proper
authorization any Know-How, comprising (i) any Alnylam
Technology other than the Core JCV Patents, and (ii) Broad
RNAi Technology Collaboration IP.
6.4.3 Step-In Rights. Subject to the provisions of any Third Party
license agreement under which Alnylam's rights in Alnylam
Technology are granted or Biogen Idec's rights in Biogen Idec
Technology are granted, and of any In-Licenses, if the Party with
the first right to enforce (the "Initial Enforcement Rights
Party") Alnylam Technology, Biogen Idec Technology, Joint
Collaboration IP or Broad RNAi Technology Collaboration IP under
Section 6.4.2 fails to initiate a suit or take other appropriate
action that it has the initial right to initiate or take pursuant
thereto within [**] days after becoming aware of the basis for
such suit or action, then the other Party (the "Secondary
Enforcement Rights Party") may, in its discretion, provide the
Initial Enforcement Rights Party with written notice of such
Secondary Enforcement Rights Party's intent to initiate a suit or
take other appropriate action. If the Secondary Enforcement
Rights Party provides such notice and the Initial Enforcement
Rights Party fails to initiate a suit or take such other
appropriate action within [**] days after receipt of such notice
from the Secondary Enforcement Rights Party, then the Secondary
Enforcement Rights Party shall have the right to initiate a suit
or take other appropriate action that it believes is reasonably
required to protect its ownership interest in and to, or licensed
interest under, as applicable, Alnylam Technology and Biogen Idec
Technology, including without limitation, Joint Collaboration IP
and Broad RNAi Technology Collaboration IP.
6.4.4 Procedures; Expenses and Recoveries. The Party having the right
to initiate any infringement suit under Section 6.4.2 or 6.4.3
above shall have the sole and exclusive right to select counsel
for any such suit and shall pay all expenses of the suit,
including attorneys' fees and court costs and reimbursement of
the other Party's reasonable out-of-pocket expense in rendering
assistance requested by the initiating Party. If required under
applicable law in order for the initiating Party to initiate
and/or maintain such suit, or if either Party is unable to
initiate or prosecute such suit solely in its own name or it is
otherwise advisable to obtain an effective legal remedy, in each
case, the other Party shall join as a party to the suit
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and will execute and cause its Affiliates to execute all
documents necessary for the initiating Party to initiate
litigation to prosecute and maintain such action. In addition, at
the initiating Party's request, the other Party shall provide
reasonable assistance to the initiating Party in connection with
an infringement suit at no charge to the initiating Party except
for reimbursement by the initiating Party of reasonable
out-of-pocket expenses incurred in rendering such assistance. The
non-initiating Party shall have the right to participate and be
represented in any such suit by its own counsel at its own
expense. If the Parties obtain from a Third Party, in connection
with such suit, any damages, license fees, royalties or other
compensation (including any amount received in settlement of such
litigation), such amounts shall be allocated as follows:
(a) In all cases, to reimburse each Party for all expenses of
the suit, including attorneys' fees and disbursements, court
costs and other litigation expenses; and
(b) subject to Section 6.4.4(d), if the infringement suit was
initiated by Biogen Idec, then any of the remaining amount
that relates to the JCV RNAi Product shall be treated as if
it were Net Sales of Biogen Idec, with Alnylam receiving a
royalty on such remaining amount pursuant to the terms of
Section 5.3.1, and the balance being retained by Biogen
Idec;
(c) subject to Section 6.4.4(d), if the infringement suit was
initiated by Alnylam, then Alnylam will pay to Biogen Idec
out of the remaining portion that relates to the JCV RNAi
Product an amount equal to the amount of royalties that
Alnylam would have received under Section 5.3.1 had such
portion been Net Sales of Biogen Idec, and the balance being
retained by Alnylam; and
(d) if the infringement suit was initiated by Alnylam pursuant
to Section 6.4.2(b), then Alnylam shall receive the full
amount remaining after reimbursement of the Parties pursuant
to Section 6.4.4(a).
6.5 CLAIMED INFRINGEMENT.
6.5.1 Notice. In the event that a Third Party at any time provides
written notice of a claim to, or brings an action, suit or
proceeding against, any Party, or any of their respective
Affiliates or Sublicensees, claiming infringement of its patent
rights or unauthorized use or misappropriation of its know-how,
based upon an assertion or claim arising out of the Discovery of
any RNAi Therapeutics directed to JCV or the Development,
Manufacture or Commercialization of a Selected RNAi Therapeutic
in the Territory ("Infringement Claim"), such Party shall
promptly notify the other Party of the claim or the commencement
of such action, suit or proceeding, enclosing a copy of the claim
and all papers served. Each Party agrees to make available to the
other Party its advice and counsel regarding the technical merits
of any such claim at no cost to the other Party and to offer
reasonable assistance to the other Party at no cost to the other
Party.
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6.5.2 Right to Defend. Biogen Idec shall have the right, but not the
obligation, to defend any Infringement Claim brought against
either Party or its Affiliates or Sublicensees arising out of the
Discovery, Development, Manufacture or Commercialization of a
Selected RNAi Therapeutic in the Territory; provided, however,
that Alnylam shall defend any such Infringement Claim relating to
Blocking RNAi Technology or Broad RNAi Technology Controlled by
Alnylam if it so desires. All litigation costs and expenses
incurred by the Defending Party (defined below) in connection
with such Infringement Claim, and all damages, payments and other
amounts awarded against, or payable by, either Party under any
settlement with such Third Party shall be borne by the Defending
Party.
6.5.3 Procedure. The Party having the obligation or first right to
defend an Infringement Claim shall be referred to as the
"Defending Party." The Defending Party shall have the sole and
exclusive right to select counsel for any Infringement Claim;
provided, that it shall consult with the other Party with respect
to selection of counsel for such defense. The Defending Party
shall keep the other Party informed, and shall from time to time
consult with the other Party regarding the status of any such
claims and shall provide the other Party with copies of all
documents filed in, and all written communications relating to,
any suit brought in connection with such claims. The other Party
shall also have the right to participate and be represented in
any such claim or related suit, at its own expense. The other
Party shall have the sole and exclusive right to control the
defense of an Infringement Claim in the event the Defending Party
fails to exercise its right to assume such defense within [**]
days following written notice from the other Party of such
Infringement Claim. No Party shall settle any claims or suits
involving rights of another Party without obtaining the prior
written consent of such other Party, which consent shall not be
unreasonably withheld.
6.5.4 Limitations. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN SECTION
9.5, THE FOREGOING STATES THE ENTIRE RESPONSIBILITY OF ALNYLAM
AND BIOGEN IDEC, AND THE SOLE AND EXCLUSIVE REMEDY OF ALNYLAM OR
BIOGEN IDEC, AS THE CASE MAY BE, IN THE CASE OF ANY CLAIMED
INFRINGEMENT OF ANY THIRD PARTY PATENT RIGHTS OR UNAUTHORIZED USE
OR MISAPPROPRIATION OF ANY THIRD PARTY'S KNOW-HOW.
6.6 OTHER INFRINGEMENT RESOLUTIONS In the event of a dispute or potential
dispute that has not ripened into a demand, claim or suit of the types
described in Sections 6.4 and 6.5 of this Agreement (e.g., actions
seeking declaratory judgments and revocation proceedings), the same
principles governing control of the resolution of the dispute, consent
to settlements of the dispute, and implementation of the settlement of
the dispute (including sharing in and allocating the payment or
receipt of damages, license fees, royalties and other compensation)
shall apply.
6.7 PRODUCT TRADEMARKS. Biogen Idec shall own the Product Trademarks for
each Selected RNAi Therapeutic and shall be solely responsible for
filing and maintaining the Product Trademarks in the Territory
(including payment of costs associated therewith). Biogen
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Idec shall assume full responsibility, at its sole cost and expense,
for any infringement of a Product Trademark for a Selected RNAi
Therapeutic by a Third Party, and shall defend and indemnify Alnylam
for and against any claims of infringement of the rights of a Third
Party by the use of a Product Trademark in connection with a Selected
RNAi Therapeutic.
6.8 PATENT TERM EXTENSIONS. The Parties shall use reasonable efforts to
obtain all available supplementary protection certificates ("SPC") and
other extensions of Patent Rights (including those available under the
Xxxxx-Xxxxxx Act). Each Party shall execute such authorizations and
other documents and take such other actions as may be reasonably
requested by the other Party to obtain such extensions. The Parties
shall cooperate with each other in gaining patent term restorations,
extensions and/or SPCs wherever applicable to Patent Rights. The Party
first eligible to seek patent term restoration or extension of any
such Patent Rights or any SPC related thereto shall have the right to
do so; provided, that if in any country the first Party has an option
to extend the patent term for only one of several patents, the first
Party shall consult with the other Party before making the election.
If more than one patent is eligible for extension or patent term
restoration, Biogen Idec shall select in good faith a strategy that
shall maximize patent protection and commercial value for each
Selected RNAi Therapeutic. All filings for such extensions and
certificates shall be made by the Party to whom responsibility for
prosecution and maintenance of the Patent Rights are assigned,
provided, that in the event that the Party to whom such responsibility
is assigned elects not to file for an extension or SPC, such Party
shall (a) inform the other Party of its intention not to file and (b)
grant the other Party the right to file for such extension or SPC in
the patentee's name, and (c) provide all necessary assistance in
connection therewith.
6.9 PATENT CERTIFICATION. To the extent required by law or permitted by
law, the Parties shall use Commercially Reasonable Efforts to maintain
with the applicable Regulatory Authorities during the Agreement Term
correct and complete listings of applicable Patent Rights for the each
Selected RNAi Therapeutic being Commercialized, including all
so-called "Orange Book" listings required under the Xxxxx-Xxxxxx Act.
ARTICLE 7
CONFIDENTIALITY
7.1 CONFIDENTIAL INFORMATION. All Confidential Information disclosed by a
Party to the other Party during the term of this Agreement shall be
used by the receiving Party solely in connection with the activities
contemplated by this Agreement, shall be maintained in confidence by
the receiving Party and shall not otherwise be disclosed by the
receiving Party to any other person, firm, or agency, governmental or
private (other than a Party's Affiliates), without the prior written
consent of the disclosing Party, except to the extent that the
Confidential Information (as determined by competent documentation):
7.1.1 was known or used by the receiving Party or its Affiliates prior
to its date of disclosure to the receiving Party; or
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7.1.2 either before or after the date of the disclosure to the
receiving Party is lawfully disclosed to the receiving Party or
its Affiliates by sources other than the disclosing Party
rightfully in possession of the Confidential Information; or
7.1.3 either before or after the date of the disclosure to the
receiving Party or its Affiliates becomes published or generally
known to the public (including information known to the public
through the sale of products in the ordinary course of business)
through no fault or omission on the part of the receiving Party,
its Affiliates or its Sublicensees; or
7.1.4 is independently developed by or for the receiving Party or its
Affiliates without reference to or reliance upon the Confidential
Information.
In addition, the provisions of this Section 7.1 shall not preclude the
receiving Party or its Affiliates from disclosing Confidential
Information to the extent such Confidential Information is required to
be disclosed by the receiving Party or its Affiliates to comply with
applicable laws, to defend or prosecute litigation or to comply with
governmental regulations, provided that the receiving Party provides
prior written notice of such disclosure to the disclosing Party and
takes reasonable and lawful actions to avoid and/or minimize the
degree of such disclosure. Specific information shall not be deemed to
be within any of the foregoing exclusions merely because it is
embraced by more general information falling within these exclusions.
Alnylam and Biogen Idec each agree that they shall provide
Confidential Information received from the other Party only to their
respective employees, consultants and advisors, and to the employees,
consultants and advisors of such Party's Affiliates, who have a need
to know and have an obligation to treat such information and materials
as confidential. All obligations of confidentiality imposed under this
Article 7 shall expire [**] years following termination or expiration
of this Agreement.
7.2 PUBLICATIONS. Biogen Idec and Alnylam each acknowledge the other
Party's interest in publishing the results of the Collaboration. Each
Party also recognizes the mutual interest in obtaining valid patent
protection and in protecting business interests and trade secret
information. Consequently, either Party, its Affiliates, or their
respective employees or consultants wishing to make a publication or a
disclosure to a Third Party relating to an RNAi Therapeutic directed
to JCV, a Selected RNAi Therapeutic or any other results of the
Collaboration shall deliver to the other Party a copy of the proposed
written publication or an outline of an oral disclosure at least [**]
days prior to submission for publication or presentation. The
reviewing Party shall have the right (a) to propose modifications to
the publication or presentation for patent reasons, trade secret
reasons or business reasons, or (b) to request a reasonable delay in
publication or presentation in order to protect patentable
information. If the reviewing Party requests a delay, the publishing
Party shall delay submission or presentation for a period of [**] days
to enable patent applications protecting each Party's rights in such
information to be filed in accordance with Article 6 above. Upon
expiration of such [**] day period, the publishing Party shall be free
to proceed with the publication or presentation. If the reviewing
Party requests modifications to the publication or presentation, the
publishing
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Party shall edit such publication to prevent disclosure of trade
secret or proprietary business information prior to submission of the
publication or presentation.
7.3 PUBLICITY/USE OF NAMES. No disclosure of the existence of, or the
terms of, this Agreement may be made by either Party, and no 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 this Agreement or its subject matter, without the prior express
written permission of the other Party, except as may be required by
law or expressly permitted by the terms hereof.
Notwithstanding the foregoing, prior to the execution of this
Agreement by both Parties, the Parties shall agree in writing upon a
press release publicizing the Collaboration to be issued jointly by
the Parties upon execution of this Agreement. After such initial press
release, neither Party shall issue a press release or public
announcement relating to the Collaboration or this Agreement without
the prior written approval of the other Party, which approval shall
not be unreasonably withheld, except that a Party may (a) once a press
release or other written 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 (b) issue a press release or
public announcement as required, in the reasonable judgment of such
Party, by applicable law, including without limitation by the rules or
regulations of the United States Securities and Exchange Commission or
similar regulatory agency in a country other than the United States or
of any stock exchange or Nasdaq, in each case after first notifying
the other Party of such planned press release or public announcement
at least [**] Business Days in advance of issuing such press release
or making such public announcement (or, with respect to press releases
and public announcements made pursuant to the foregoing clause (b),
with as much advance notice as possible under the circumstances if it
is not possible to provide notice at least [**] Business Days in
advance) for the sole purpose of allowing the other Party to review
the proposed press release or public announcement for the inclusion of
Confidential Information or the use of its name.
ARTICLE 8
TERM AND TERMINATION
8.1 TERM; EXTENSION. This Agreement shall be effective as of the Effective
Date and, unless terminated earlier pursuant to Section 8.2 below,
this Agreement shall continue in effect until expiration of all
payment obligations hereunder pursuant to Section 5.4.3 ("Agreement
Term"). Upon expiration of the Agreement Term, all licenses of the
Parties under Article 4 then in effect shall become fully paid-up,
perpetual licenses.
8.2 TERMINATION FOR CAUSE.
8.2.1 Cause for Termination. This Agreement may be terminated at any
time during the Term:
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(a) upon written notice by either Party if the other Party (the
"Breaching Party") is in breach of its material obligations
hereunder by causes and reasons within its control and has
not cured such breach within sixty (60) days after notice
requesting cure of the breach; or
(b) by either Party upon the filing or institution of
bankruptcy, reorganization, liquidation or receivership
proceedings, or upon an assignment of a substantial portion
of the assets for the benefit of creditors by the other
Party; provided, however, that in the event of any
involuntary bankruptcy or receivership proceeding such right
to terminate shall only become effective if the Party
consents to the involuntary bankruptcy or receivership or
such proceeding is not dismissed within ninety (90) days
after the filing thereof.
8.2.2 Effect of Termination for Cause.
(a) Termination by Alnylam. Without limiting any other legal or
equitable remedies that Alnylam may have, if Biogen Idec is
the Breaching Party and Alnylam terminates this Agreement in
accordance with Section 8.2.1(a), then
(i) the license granted to Alnylam pursuant to Section
4.1.5 shall survive and the licenses granted to Biogen
Idec under this Agreement shall terminate;
(ii) in the event that Alnylam is Manufacturing and
supplying a Selected RNAi Therapeutic pursuant to
Section 2.10.1, Biogen Idec shall have the obligation
to reimburse Alnylam for any committed and
non-refundable or non-creditable costs or expenses
incurred by the Alnylam, as of the date of notice of
termination, with respect to the supply of each such
Selected RNAi Therapeutic, and shall purchase, at the
transfer price pursuant to Section 5.1.2, any Selected
RNAi Therapeutic Manufactured and supplied by Alnylam,
as well as any work in progress, raw materials,
intermediates or components relating to such Selected
RNAi Therapeutic; and
(b) Termination by Biogen Idec. Without limiting any other legal
or equitable remedies that Biogen Idec may have, if Alnylam
is the Breaching Party and Biogen Idec terminates this
Agreement in accordance with Section 8.2.1(a), then
(i) the licenses granted to Alnylam under this Agreement
shall terminate and the licenses granted to Biogen Idec
under this Agreement shall continue in full force and
effect; provided, however, that to the extent such
licenses include a sublicense of
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Know-How or Patent Rights owned or controlled by a
Third Party, including without limitation the Existing
Alnylam In-Licenses, Biogen Idec shall be fully
responsible for all royalties, milestones or other
payments under such In-Licenses reasonably allocable to
the Selected RNAi Therapeutics; and
(ii) in the event that Alnylam is Manufacturing and
supplying a Selected RNAi Therapeutic pursuant to
Section 2.10.1, Alnylam shall have the obligation, if
requested by Biogen Idec, to continue to Manufacture
and supply such Selected RNAi Therapeutic in accordance
with the terms of the applicable supply agreement.
Alnylam will cooperate in any reasonable manner
requested by Biogen Idec to achieve a smooth transition
of the Development and Manufacturing of each such
Selected RNAi Therapeutic to Biogen Idec or Biogen
Idec's licensees.
(c) Termination upon Bankruptcy of a Party. If this Agreement is
terminated by either Party (the "Non-Bankrupt Party")
pursuant to Section 8.2.1(b) due to the rejection of this
Agreement by or on behalf of the other Party (the "Bankrupt
Party") under Section 365 of the United States Bankruptcy
Code (the "Code"), all licenses and rights to licenses
granted under or pursuant to this Agreement by the Bankrupt
Party to the Non-Bankrupt Party are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the Code,
licenses of rights to "intellectual property" as defined
under Section 101(35A) of the Code. The Parties agree that
the Non-Bankrupt Party, as a licensee of such rights under
this Agreement, shall retain and may fully exercise all of
its rights and elections under the Code, and that upon
commencement of a bankruptcy proceeding by or against the
Bankrupt Party under the Code, the Non-Bankrupt Party shall
be entitled to a complete duplicate of, or complete access
to (as the Non-Bankrupt Party deems appropriate), any such
intellectual property and all embodiments of such
intellectual property. Such intellectual property and all
embodiments thereof shall be promptly delivered to the
Non-Bankrupt Party (i) upon any such commencement of a
bankruptcy proceeding upon written request therefor by the
Non-Bankrupt Party, unless the Bankrupt Party elects to
continue to perform all of its obligations under this
Agreement or (ii) if not delivered under (i) above, upon the
rejection of this Agreement by or on behalf of the Bankrupt
Party upon written request therefor by the Non-Bankrupt
Party. The foregoing provisions are without prejudice to any
rights the Non-Bankrupt Party may have arising under the
Code or other applicable law.
8.3 TERMINATION FOR CONVENIENCE. Biogen Idec shall have the right to
terminate this Agreement, on a country-by-country basis or in its
entirety, for any reason upon ninety (90) days' advance written notice
to Alnylam after completion of the Discovery Term. During the
Discovery Term, Biogen Idec shall have the right to terminate this
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Agreement, on a country-by-country basis or in its entirety, for any
reason upon four (4) months' advance written notice to Alnylam.
8.4 EFFECT OF EXPIRATION OR TERMINATION; SURVIVAL. Expiration or
termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or termination. Any
expiration or termination of this Agreement shall be without prejudice
to the rights of either Party against the other accrued or accruing
under this Agreement prior to expiration or termination, including
without limitation the obligation to make payments in respect of
Selected RNAi Therapeutics sold or used prior to such expiration or
termination. The provisions of Articles 1, 6, 7, 10, and Sections
4.2.6, 8.2.2, 8.4 and 9.5 shall survive any expiration or termination
of this Agreement. In addition, Section 4.1.5 will survive expiration
or termination of this Agreement for any reason other than Alnylam's
breach. Except as set forth in this Article 8, upon termination or
expiration of this Agreement all other rights and obligations cease.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
9.1 MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party represents and
warrants to the other Party that as of the Effective Date of this
Agreement:
9.1.1 It is duly organized and validly existing under the laws of its
jurisdiction of incorporation or formation, and has full
corporate or other power and authority to enter into this
Agreement and to carry out the provisions hereof. Further, except
for any Regulatory Approvals, pricing and/or reimbursement
approvals, manufacturing approvals and/or similar approvals
necessary for the Development, Manufacture or Commercialization
of the Selected RNAi Therapeutics, all necessary consents,
approvals and authorizations of all government authorities
required to be obtained by such Party as of the Effective Date in
connection with the execution, delivery and performance of this
Agreement have been obtained by the Effective Date.
9.1.2 It is duly authorized to execute and deliver this Agreement and
to perform its obligations hereunder, and the person or persons
executing this Agreement on its behalf has been duly authorized
to do so by all requisite corporate action.
9.1.3 This Agreement is legally binding upon it and enforceable in
accordance with its terms. Except as set forth in Section 9(a) of
Schedule 9 to this Agreement, the execution, delivery and
performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which
it is a party and by which it may be bound.
9.1.4 Except, in Alnylam's case, as set forth in Section 9(a) of
Schedule 9 to this Agreement, it has not, and will not during the
Agreement Term, grant any right to any Third Party which would
conflict with the rights granted to the other Party
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hereunder. It has (or will have at the time performance is due)
maintained and will maintain and keep in full force and effect
all agreements (including license agreements) and filings
(including patent filings) necessary in such Party's reasonable
judgment to perform its obligations hereunder. Further, the
execution and delivery of this Agreement by such Party, the
performance of such Party's obligations hereunder and the
licenses and sublicenses to be granted by such Party pursuant to
this Agreement do not conflict with or violate any requirement of
applicable laws or regulations existing as of the Effective Date
and applicable to such Party.
9.1.5 Neither Party nor any of its Affiliates has been debarred or is
subject to debarment and neither Party nor any of its Affiliates
will use in any capacity, in connection with the Discovery,
Development, Manufacture or Commercialization of an RNAi
Therapeutic under this Agreement, any person or entity that has
been debarred pursuant to Section 306 of the United States
Federal Food, Drug, and Cosmetic Act, or that is the subject of a
conviction described in such section. Each Party agrees to inform
the other Party in writing immediately if it or any person or
entity that is performing activities under the Collaboration is
debarred or is the subject of a conviction described in Section
306, or if any action, suit, claim, investigation or legal or
administrative proceeding is pending or, to the best of such
Party's knowledge, is threatened, relating to the debarment or
conviction of such Party or any person or entity used in any
capacity by such Party or any of its Affiliates in connection
with the Discovery, Development, Manufacture or Commercialization
of an RNAi Therapeutic under this Agreement.
9.2 ALNYLAM REPRESENTATIONS AND WARRANTIES. Alnylam represents and
warrants to Biogen Idec that as of the Effective Date of this
Agreement:
9.2.1 Alnylam Controls the Alnylam Patent Rights and is entitled to
grant the licenses specified herein. Subject to Section 4.5, the
Alnylam Patent Rights constitute all of the Patent Rights
Controlled by Alnylam as of the Effective Date that relate to or
are necessary to practice the Alnylam Patent Rights. Except as
set forth in Section 9(a) of Schedule 9 to this Agreement,
Alnylam has not previously assigned, transferred, conveyed or
otherwise encumbered its right, title and interest in the Alnylam
Technology in a manner that conflicts with any rights granted to
Biogen Idec hereunder. During the Term of this Agreement, Alnylam
shall not encumber the rights granted to Biogen Idec hereunder
with respect to the Alnylam Patent Rights.
9.2.2 To the best knowledge of Alnylam and its Affiliates, except as
set forth in Schedule 9(c), there is no actual or threatened
infringement of the Alnylam Patent Rights in the Field by any
Third Party or any other infringement or threatened infringement
that would adversely affect Biogen Idec's rights under this
Agreement.
9.2.3 To the best knowledge of Alnylam and its Affiliates, the Alnylam
Patent Rights are existing as of the Effective Date are
subsisting and are not invalid or
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unenforceable, in whole or in part. The conception, development
and reduction to practice of the Alnylam Patent Rights existing
as of the Effective Date have not constituted or involved the
misappropriation of trade secrets or other rights or property of
any Person. There are no claims, judgments or settlements against
or amounts with respect thereto owed by Alnylam or any of its
Affiliates relating to the Alnylam Patent Rights. Except as set
forth in Section 9(b) of Schedule 9 to this Agreement, no claim
or litigation has been brought or threatened by any Third Party
alleging, and Alnylam is not aware of any reasonable basis for a
claim, whether or not asserted, that (a) the Alnylam Patent
Rights are invalid or unenforceable or (b) the Alnylam Patent
Rights or the disclosing, copying, making, assigning, licensing
or exploiting of the Alnylam Patent Rights violates, infringes or
otherwise conflicts or interferes with any intellectual property
or proprietary right of any Third Party.
9.2.4 To the best of Alnylam's actual knowledge, except as set forth
in Section 9(b) of Schedule 9 to this Agreement, there are no
claims, judgments or settlements against or owed by Alnylam or
its Affiliates or pending or threatened claims or litigation
relating to the Alnylam Technology that are expected to impact
the Collaboration or any RNAi Therapeutic directed to JCV.
9.3 BIOGEN IDEC REPRESENTATIONS AND WARRANTIES. Biogen Idec represents and
warrants to Alnylam that as of the Effective Date of this Agreement:
9.3.1 To the best of Biogen Idec's knowledge, the Biogen Idec Patent
Rights exist and are not invalid or unenforceable, in whole or in
part;
9.3.2 It has not previously assigned, transferred, conveyed or
otherwise encumbered its right, title and interest in the Biogen
Idec Technology in a manner that conflicts with the rights
granted to Alnylam hereunder; and
9.3.3 There are no claims, judgments or settlements against or owed by
Biogen Idec or its Affiliates or pending or threatened claims or
litigation relating to the Biogen Idec Technology that are
expected to impact the Collaboration or any RNAi Therapeutic
directed to JCV.
9.4 WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY
WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY
WITH RESPECT TO ANY TECHNOLOGY, RNAi THERAPEUTICS, GOODS, SERVICES,
RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS
ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND NONINFRINGEMENT 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 RNAi
THERAPEUTIC UNDER THIS AGREEMENT WILL BE SUCCESSFUL.
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9.5 INDEMNIFICATION AND INSURANCE.
9.5.1 Indemnification by Biogen Idec. Biogen Idec shall indemnify,
hold harmless, and defend Alnylam, its Affiliates, 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) (collectively, "Losses")
arising out of or resulting from, directly or indirectly, (a) any
breach of, or inaccuracy in, any representation or warranty made
by Biogen Idec in this Agreement, or any breach or violation of
any covenant or agreement of Biogen Idec in or pursuant to this
Agreement, (b) the negligence or willful misconduct by or of
Biogen Idec, its Affiliates and their respective Sublicensees,
and their respective directors, officers, employees and agents,
or (c) the Discovery, Development, Manufacture or
Commercialization of a JCV RNAi Product to the extent such
activities are not performed by Alnylam or its agents. This
indemnification excludes Losses arising out of Third Party
Infringement Claims resulting from Biogen Idec's exercise in
accordance with the terms of this Agreement of any intellectual
property rights granted by Alnylam hereunder. Furthermore, Biogen
Idec 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 pursuant to this Agreement, or the negligence or
willful misconduct by or of any of the Alnylam Indemnitees,
and/or the Discovery, Development or Manufacture of a JCV RNAi
Therapeutic, to the extent performed such activities are
performed by Alnylam or its agents.
9.5.2 Indemnification by Alnylam. Alnylam shall indemnify, hold
harmless, and defend Biogen Idec, its Affiliates and their
respective directors, officers, employees and agents ("Biogen
Idec 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 pursuant to this
Agreement, (b) the negligence or willful misconduct by or of
Alnylam, its Affiliates and their respective Sublicensees, and
their respective directors, officers, employees and agents or (c)
the Discovery, Development or Manufacture of a JCV RNAi
Therapeutic, to the extent performed by Alnylam or its agents.
This indemnification excludes Losses arising out of Third Party
Infringement Claims resulting from Alnylam's exercise in
accordance with the terms of this Agreement of any intellectual
property rights granted by Biogen Idec hereunder. Furthermore,
Alnylam shall have no obligation to indemnify the Biogen Idec
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 Biogen Idec in this
Agreement, or any breach or violation of any covenant or
agreement of Biogen Idec in or pursuant to this Agreement, or the
negligence or willful misconduct by or of any of the Biogen Idec
Indemnitees, and/or the Discovery, Development, Manufacture or
Commercialization of a JCV
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RNAi Product to the extent such activities are not performed by
Alnylam or its agents.
9.5.3 Indemnification Procedure. In the event of any such claim
against any Biogen Idec 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 9.5.1 or 9.5.2 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.
9.5.4 Insurance. Each Party shall use all Commercially Reasonable
Efforts to maintain insurance, including product liability
insurance, with respect to its activities hereunder. Such
insurance shall be in such amounts and subject to such
deductibles as the Parties may agree based upon standards
prevailing in the industry at the time. At such time as the any
Selected RNAi Therapeutic is being manufactured by Biogen Idec
for commercial sale, Biogen Idec shall name Alnylam as an
additional insured on any such policies.
ARTICLE 10
MISCELLANEOUS PROVISIONS
10.1 GOVERNING LAW. This Agreement shall be construed and the respective
rights of the Parties determined according to the substantive laws of
the Commonwealth of Massachusetts notwithstanding the provisions
governing conflict of laws under such Massachusetts law to the
contrary.
10.2 ASSIGNMENT.
10.2.1 In General. Except as provided in this Section 10.2, this
Agreement may not be assigned or otherwise transferred, nor may
any right or obligation hereunder be assigned or transferred, by
either Party without the consent of the other Party. However,
either Party may, without the other Party's consent, assign this
Agreement and its rights and obligations hereunder in whole or in
part to an Affiliate or to a party that acquires, by merger, sale
of assets or otherwise, all or substantially all of the business
of the assigning Party to which the subject matter of this
Agreement relates. The assigning Party shall remain responsible
for the
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performance by its assignee of this Agreement or any obligations
hereunder so assigned to such assignee.
10.2.2 [**].
10.3 AMENDMENTS. This Agreement, the Schedules referred to in this
Agreement and the [**] Sublicense Agreement constitute the entire
agreement between 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. Any amendment or
modification to this Agreement shall be made in writing signed by both
Parties.
10.4 NOTICES. Any notice required or provided for by the terms of this
Agreement shall be in writing and shall be (a) sent by registered or
certified mail, return receipt requested, postage prepaid, (b) sent
via a reputable overnight courier service, or (c) sent by facsimile
transmission, in each case properly addressed in accordance with the
paragraphs below. The effective date of notice shall be the actual
date of receipt by the Party receiving the same.
Notices to Alnylam shall be addressed to:
Alnylam Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx, Xxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Chief Executive Officer
Facsimile No.: (000) 000-0000
with a copy to:
FABER DAEUFER & XXXXXXXXX, P.C.
000 Xxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxx, XX 00000
Attention: Sumy X. Xxxxxxx
Facsimile No.: (000) 000-0000
Notices to Biogen Idec shall be addressed to:
Biogen Idec MA, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: _________________________
Facsimile No.: (617) _______________
with a copy to:
Ropes & Xxxx
Xxx Xxxxxxxxxxxxx Xxxxx
Xxxxxx, XX 00000
Attention: Xxxx X. Xxxxxxxxxx
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Facsimile No.: (000) 000-0000
Either Party may change its address to which notices shall be
sent by giving notice to the other Party in the manner herein
provided.
10.5 FORCE MAJEURE. No failure or omission by either Party in the
performance of any obligation of this Agreement shall be deemed a
breach of this Agreement or create any liability if the same shall
arise from any cause or causes beyond the control of such Party,
including, but not limited to, the following: acts of god; acts or
omissions of any government; any rules, regulations or orders issued
by any governmental authority or by any officer, department, agency or
instrumentality thereof; fire; storm; flood; earthquake; accident;
war; rebellion; insurrection; riot; and invasion; provided that such
failure or omission resulting from one of the above causes is cured as
soon as is practicable.
10.6 COMPLIANCE WITH EXPORT REGULATIONS. Neither Party shall export any
technology licensed to it by the other Party under this Agreement
except in compliance with U.S. export laws and regulations.
10.7 INDEPENDENT CONTRACTORS. It is understood and agreed that the
relationship between the Parties is that of independent contractors
and that nothing in this Agreement shall be construed as authorization
for either Alnylam or Biogen Idec to act as agent for the other.
Nothing herein contained shall be deemed to create an employment,
agency, joint venture or partnership relationship between the Parties
or any of their agents or employees for any purpose, including tax
purposes, or to create any other legal arrangement that would impose
liability upon one Party for the act or failure to act of the other
Party. Neither Party shall have any express or implied power to enter
into any contracts or commitments or to incur any liabilities in the
name of, or on behalf of, the other Party, or to bind the other Party
in any respect whatsoever.
10.8 NO STRICT CONSTRUCTION. This Agreement has been prepared jointly and
shall not be strictly construed against either Party.
10.9 HEADINGS. The captions or headings of the sections or other
subdivisions hereof are inserted only as a matter of convenience or
for reference and shall have no effect on the meaning of the
provisions hereof.
10.10 NO IMPLIED WAIVERS; RIGHTS CUMULATIVE. No failure on the part of
Alnylam or Biogen Idec to exercise, and no delay in exercising, any
right, power, remedy or privilege under this Agreement, or provided by
statute or at law or in equity or otherwise, shall impair, prejudice
or constitute a waiver of any such right, power, remedy or privilege
or be construed as a waiver of any breach of this Agreement or as an
acquiescence therein, nor shall any single or partial exercise of any
such right, power, remedy or privilege preclude any other or further
exercise thereof or the exercise of any other right, power, remedy or
privilege.
10.11 SEVERABILITY. If any provision hereof should be held invalid, illegal
or unenforceable in any respect in any jurisdiction, the Parties
hereto shall substitute, by mutual consent,
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valid provisions for such invalid, illegal or unenforceable
provisions, which valid provisions in their economic effect are
sufficiently similar to the invalid, illegal or unenforceable
provisions that it can be reasonably assumed that the Parties would
have entered into this Agreement with such valid provisions. In case
such valid provisions cannot be agreed upon, the invalid, illegal or
unenforceable of one or several provisions of this Agreement shall not
affect the validity of this Agreement as a whole, unless the invalid,
illegal or unenforceable provisions are of such essential importance
to this Agreement that it is to be reasonably assumed that the Parties
would not have entered into this Agreement without the invalid,
illegal or unenforceable provisions.
10.12 EXECUTION IN COUNTERPARTS. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and
delivered, shall be deemed to be an original, and all of which
counterparts, taken together, shall constitute one and the same
instrument.
10.13 NO THIRD PARTY BENEFICIARIES. Except as set forth in Section 10.2.2.,
no person or entity other than Biogen Idec, Alnylam 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.
10.14 NO CONSEQUENTIAL DAMAGES. NEITHER PARTY HERETO WILL BE LIABLE FOR
SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS
AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT
LIMITATION LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS
AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS
SECTION 10.14 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF EITHER PARTY OR TO LIMIT A PARTY'S LIABILITY
FOR BREACHES OF ITS OBLIGATION REGARDING CONFIDENTIALITY UNDER ARTICLE
7.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first set forth above.
ALNYLAM PHARMACEUTICALS, INC.
By: /s/ Xxxx X. Xxxxxxxxxx
------------------------------------
Title: President and Chief
Executive Officer
BIOGEN IDEC MA, INC.
By: /s/ Xxxxx X. Xxxxxx
------------------------------------
Title: President and Chief
Executive Officer
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SCHEDULE 1.6
ALNYLAM PATENT RIGHTS
1.6.1 PATENTS AND PATENT APPLICATIONS OWNED BY ALNYLAM OR LICENSED
FROM THIRD PARTIES OTHER THAN ISIS PHARMACEUTICALS, INC.
Alnylam Patent Rights include all claims of the patents and patent
applications listed in Schedule 1.6.1, attached, explicitly excluding
[**]. The patents and patent applications listed in Schedule 1.6.1 are
either owned by Alnylam or licensed from Third Parties other than Isis
Pharmaceuticals, Inc. ("Isis").
1.6.2 PATENTS AND PATENT APPLICATIONS LICENSED FROM ISIS
Alnylam Patent Rights also include rights to a broad portfolio of
patents and patent applications (the "Isis Patents") licensed to
Alnylam by Isis pursuant to the Strategic Collaboration & License
Agreement between Isis and Alnylam dated March 11, 2004 (the "Isis
Agreement"). The Isis Patents are described in Schedules 1-27 and 1-28
of the Isis Agreement and are attached to this Agreement as Schedule
1.6.2. Schedule 1.6.2(a) lists those Isis Patents classified in the
Isis Agreement as "Isis Current Motif and Mechanism Patents" and
listed in Schedule 1-28 of the Isis Agreement. Schedule 1.6.2(b) lists
those Isis Patents classified in the Isis Agreement as "Isis Current
Chemistry Patents" and listed in Schedule 1-27 of the Isis Agreement.
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SCHEDULE 1.6.1
PATENTS AND PATENT APPLICATIONS OWNED BY ALNYLAM OR LICENSED FROM THIRD PARTIES
OTHER THAN ISIS PHARMACEUTICALS, INC.
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions
Application Publication Publication Issue
Case No. Title Country Type No. Filing Date No. Date Patent No. Date
-------- ----- ------- ---- ----------- ----------- ----------- ----------- ---------- -----
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
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SCHEDULE 1.6.2
PATENT AND PATENT APPLICATIONS LICENSED FROM ISIS PHARMACEUTICALS, INC.
SCHEDULE 1.6.2(A): ISIS CURRENT MOTIF AND MECHANISM PATENTS
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions
ISIS DOCKET PATENT GRANT 3RD 3RD
NUMBER COUNTRY STATUS NUMBER DATE TITLE PARTY PARTY
----------- ------- ------ ------ ----- ----- ----- -----
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
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SCHEDULE 1.6.2(B): ISIS CHEMISTRY PATENTS
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions
ISIS DOCKET COUNTRY PATENT GRANT 3RD 3RD
NUMBER NAME STATUS NUMBER DATE TITLE PARTY PARTY
----------- ------- ------ ------ ----- ----- ----- -----
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**]
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SCHEDULE 1.8
ANNUAL WORK PLAN
OVERALL OBJECTIVE
Develop an RNAi therapeutic that inhibits JCV for the treatment of PML.
MOLECULAR HYPOTHESIS
[**]
THERAPEUTIC HYPOTHESIS
[**]
TECHNICAL RATIONALE
[**]
OVERVIEW OF ANNUAL WORK PLAN - DISCOVERY PROGRAM, YEAR 1
This Annual Work Plan describes the Discovery Program, or candidate
identification phase, from now (Q4 2006) until [**]. The Development Program, or
pre-clinical development phase, will comprise [**] studies that commence in [**]
after [**], such that the IND can be filed in [**]. Thus, CMC activities will
begin [**] prior to [**], and are [**].
DETAILS OF ANNUAL WORK PLAN - DISCOVERY PROGRAM, YEAR 1
The primary objective of the Discovery Program (Year 1) is to [**] A second
major objective of Year 1 comprises [**]. Thus, the [**] goals for Year 1 are:
[**] Goals for Year 1 [**]
[**] Goals for Year 1
[**]
Development Criteria
The target profile for RNAi Therapeutics directed to JCV is:
[**]
The major goals for Year 1 are described in further detail below.
[**]
We will begin by [**]
[**]
We will [**]. In order to [**]. We will use[**]. We will assess [**] After a
[**]
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Based upon the [**]
The process consists of [**].
The components for the [**]
The [**] processes will be [**].
Timeline and Budget
The table below provides the major goals and tasks for the Discovery Program,
Year 1 (Q1-Q4) as well as the Development Program, along with projected
associated timelines, and projected associated internal resources (FTEs) and
external expenses. [**]
The projected budget for Year 1 follows. Note that there may be additional
costs, that would need further JSC approval, associated with [**]
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SCHEDULE 1.11
BIOGEN IDEC IN-LICENSES
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SCHEDULE 1.27
CORE JCV PATENTS
[**]
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SCHEDULE 1.41
EXISTING ALNYLAM IN-LICENSES
Existing Alnylam In-Licenses shall include the following Third Party agreements:
1. [**].
2. [**].
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SCHEDULE 4.5
[**] SUBLICENSE AGREEMENT
LICENSE AGREEMENT
This LICENSE AGREEMENT (this "License Agreement"), effective as of September 20,
2006 (the "Effective Date"), is by and between Biogen Idec MA Inc., a
corporation organized and existing under the laws of the Commonwealth of
Massachusetts and having its principal office at 00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx,
XX 00000 ("Biogen Idec"), and Alnylam Pharmaceuticals, Inc., a corporation
organized and existing under the laws of Delaware, with its principal place of
business at 000 Xxxxx Xxxxxx, 0xx Xxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000
("Alnylam"). Biogen Idec and Alnylam are each sometimes referred to herein
individually as a "Party" and collectively as "Parties."
RECITALS
WHEREAS, Biogen Idec and Alnylam have entered into the Collaboration
and License Agreement (the "Collaboration Agreement") as of the Effective Date;
WHEREAS, Alnylam U.S., Inc. (then known as Alnylam Pharmaceuticals,
Inc.) is a party to that certain License Agreement [**].
WHEREAS, Alnylam wishes to sublicense to Biogen Idec, and Biogen Idec
wishes to sublicense from Alnylam, the [**] Patent Rights (as defined in the
[**] Agreement) pursuant to the terms of this License Agreement.
NOW, THEREFORE, in consideration of the respective covenants and
agreements contained herein, and for other valuable consideration, the receipt
and adequacy of which are hereby acknowledged, Alnylam and Biogen Idec agree as
follows:
ARTICLE 1
DEFINITIONS
All capitalized terms used herein that are not otherwise defined
herein shall have the meaning given to such terms in the Collaboration
Agreement.
"Blocking IP" shall mean any and all Patent Rights (other than those
licensed under this License Agreement or Patent Rights Controlled by Alnylam)
which, if claims covering subject matter of such Patent Rights issue, would
render the use, development, manufacture, sale, or other disposal of a Selected
RNAi Therapeutic which is a [**] Licensed Product unlawful in the absence of a
license to such Patent Rights from a Third Party.
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"[**] Agreement" shall have the meaning given to such term in the
Recitals.
"[**] Field" shall mean the development of Selected RNAi Therapeutics
for the treatment of human disease (including by means of gene therapy).
"[**] Licensed Product" shall mean a product or products which, or the
process of production of which, or the use of which falls within the scope of a
Valid Claim (as defined in the [**] Agreement) of the [**] Patent Rights.
"[**] Patent Rights" shall have the meaning given to such term in the
[**] Agreement, which include the rights identified on Schedule A hereto.
ARTICLE 2
LICENSE GRANT
2.1 LICENSES
Subject to the terms and conditions of the Collaboration Agreement and
of Section 2.3 of this License Agreement, Alnylam hereby grants to Biogen Idec
and its Affiliates:
(i) A co-exclusive (with Alnylam), worldwide, royalty-free right and
sublicense under [**] Patent Rights to Discover RNAi Therapeutics directed to
JCV that are [**] Licensed Products in the Field 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;
(ii) A co-exclusive (with Alnylam), worldwide, royalty-free right and
sublicense under [**] Patent Rights to Develop Selected RNAi Therapeutics that
are [**] Licensed Products in the Field in the Territory, to the extent
necessary for Biogen Idec to conduct its activities under the Annual Work Plan;
and
(iii) An exclusive, worldwide, royalty-free right and sublicense under
[**] Patent Rights to Commercialize Selected RNAi Therapeutics that are [**]
Licensed Products in the Field in the Territory.
2.2 BIOGEN IDEC SUBLICENSE RIGHTS
In addition to the requirements of the Collaboration Agreement
(including, but not limited to, Section 4.2 of the Collaboration Agreement),
sublicensing of Biogen Idec's rights under Section 2.1 will be permitted subject
to the following provisions: (i) Biogen Idec's Sublicensees shall have no right
to grant further sublicenses without Alnylam's written consent, which consent
shall not be unreasonably withheld or delayed; and (ii) Biogen Idec shall be
primarily liable for any failure by its Sublicensees to comply with, and Biogen
Idec guarantees to Alnylam the compliance by each of its Sublicensees
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with, all relevant restrictions, limitations and obligations in this License
Agreement. In the event of a conflict between the terms of the Collaboration
Agreement and this Section 2.2 with regard to any sublicense of the [**] Patent
Rights by Biogen Idec, this Section 2.2 will control.
2.3 RESERVATION OF RIGHTS
(i) For the sake of clarity, save to the extent necessary for the
Development and/or Commercialization of Selected RNAi Therapeutics which are
[**] Licensed Products in the [**] Field, neither Biogen Idec nor any Affiliate
is granted the right to make use of the [**] Patent Rights to research, develop,
use, keep, make, have made, sell and otherwise dispose or offer to dispose of
products:
a) for any diagnostic application;
b) as research tools or reagents;
c) for target validation; or
d) small molecule drug discovery
including the provision of services in relation thereto to Affiliates or Third
Parties (as defined in the [**] Agreement).
(ii) Biogen Idec acknowledges and agrees that, pursuant to Section 2.3
of the [**] Agreement, [**] and [**] shall have the right to use, and [**] shall
have the right to consent to the use by academic research institutions
(including for the sake of clarity those in receipt of [**] funding) of, the
[**] Patent Rights in the Field for internal, or in collaboration with another
academic research institution, non-commercial, non-commercially sponsored
research. For the sake of clarity, [**]-funded Researchers (as defined in the
[**] Agreement) shall be permitted under the [**] Patent Rights to conduct
clinical trials of potential dsRNA therapeutic agents as part of their
[**]-funded academic research.
(iii) Biogen Idec acknowledges and agrees that the grants by Alnylam
under [**] Patent Rights set forth in Sections 2.1 and 2.2 will be subject to
the terms and conditions of Sections 4.4, 6.4.2(a), 6.4.3 and 8.2.2(b)(i) of the
Collaboration Agreement as though [**] Patent Rights were included in Alnylam
Patent Rights and the [**] Agreement was an Existing Alnylam In-License.
ARTICLE 3
FINANCIAL PROVISIONS
3.1 UPFRONT CONSIDERATION
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In consideration of the rights granted to Biogen Idec under this
License Agreement as of the Effective Date, Biogen Idec shall pay, or cause to
be paid, to Alnylam [**] dollars ($[**]) within ten (10) Business Days following
the Effective Date.
3.2 ROYALTIES
Biogen Idec shall pay, or cause to be paid, to Alnylam royalties of
[**] per cent ([**]%) of Net Sales (as defined in the [**] Agreement) of Royalty
Licensed Products (as defined in the [**] Agreement) in the [**] Field.
3.3 ROYALTY STACKING
Provided always that the royalty payable under Section 3.2 of this
License Agreement to Alnylam shall not in any event be reduced below [**]
percent ([**]%), if at any time prior to or during the period for the payment of
royalties under this License Agreement in relation to any particular territory,
Biogen Idec (or its Affiliate as the case may be) or a Sublicensee elects in its
reasonable opinion to take a license from a Third Party to any Blocking IP to
develop, make, sell or otherwise dispose in the Field of Selected RNAi
Therapeutics that are [**] Licensed Products, the royalties set forth in Section
3.2 applicable to such Selected RNAi Therapeutic (as defined in the [**]
Agreement) shall be reduced by [**]% of the amount paid to such Third Party to
access said Blocking IP.
3.4 CREDIT UNDER COLLABORATION AGREEMENT
All payments made under the Collaboration Agreement shall be credited
against payments due under this Agreement such that no payments shall be due to
Alnylam under this Agreement that are in addition to the payments required to be
made by Biogen Idec to Alnylam under the Collaboration Agreement.
ARTICLE IV
COMPLIANCE WITH [**] AGREEMENT
Pursuant to the requirements of clause 2.4 of the [**] Agreement:
4.1 TERMINATION
The term and termination of this License Agreement shall be governed
by Article 8 of the Collaboration Agreement as though [**] Patent Rights were
included in Alnylam Patent Rights, provided that:
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(a) This License Agreement shall terminate automatically on the expiry
or termination for whatever reason of the [**] Agreement.
(b) In the event of termination of the [**] Agreement pursuant to
Clause 10 of the [**] Agreement, [**] has agreed that it will enter into a
direct licensing arrangement with Biogen Idec on terms substantially similar to
those contained herein save that any license granted by [**] to Biogen Idec
shall be consistent with the terms of this License Agreement in relation to
field, territory, exclusivity, rights to sub-license and payment provisions.
However, in the event of termination of the [**] Agreement by Alnylam pursuant
to Clause 10.2 of such [**] Agreement, the provisions of the foregoing sentence
shall apply save that the granting of such license by [**] shall be subject to
[**]'s consent. Biogen Idec acknowledges and agrees that (i) [**] shall have no
obligation to enter into a direct licensing arrangement with Biogen Idec where
Biogen Idec is in default of its obligations under this License Agreement; (ii)
[**] shall not be expected to take any responsibility for any disputes between
Alnylam (or its Affiliate as the case may be) and Biogen Idec relating to the
terms of this License Agreement, and (iii) notwithstanding the foregoing
provisions of this Section 4.1(b), [**] shall not be obliged to enter into a
direct license with Biogen Idec in circumstances in which Biogen Idec reserves
any right to maintain a claim against [**] where such claim was previously
maintained against Alnylam (or its Affiliate as the case may be).
4.2 BOOKS AND RECORDS
Biogen Idec shall undertake to [**] directly to allow [**] the same
access to Biogen Idec's books and records as [**] has to Alnylam's books and
records under the [**] Agreement; and
4.3 ASSIGNMENT
(a) Subject to Section 4.3(b), neither Party shall without the prior
written consent of the other Party, which shall not be unreasonably withheld,
assign the benefit and/or burden of this License Agreement nor sub-contract any
of its obligations hereunder unless otherwise permitted by the terms hereof.
(b) Either Party shall be entitled to assign the benefit and/or burden
of this License Agreement to any Affiliate or to its successor in connection
with any merger, consolidation or sale or other disposal of all or substantially
all of its assets and/or business to which this License Agreement relates.
(c) Notwithstanding anything to the contrary contained in this
Agreement, if the Collaboration Agreement is assigned [**], Alnylam hereby
consents to
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the assignment of this Agreement [**] on the same terms and conditions as the
assignment of the Collaboration Agreement as set forth in such Section 10.2.2.
4.4 SUB-LICENSES
Any sub-license granted by Biogen Idec under this License Agreement
shall be subject to the terms of this Article IV and Sections 2.2 and 2.3 of
this License Agreement.
ARTICLE V
OTHER TERMS AND CONDITIONS
Except as explicitly set forth to the contrary in Articles I through
IV of this License Agreement, the grant of the [**] Patent Rights under Sections
2.1 and 2.2 shall be governed by the terms and conditions of the Collaboration
Agreement as though such [**] Patent Rights were included in Alnylam Patent
Rights. Alnylam has disclosed to Biogen Idec a redacted copy of the [**]
Agreement Contracts and all amendments thereto.
[Remainder of Page Intentionally Left Blank]
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IN WITNESS WHEREOF, Alnylam and Biogen Idec have caused this License
Agreement to be duly executed by their authorized representatives, as of the
date first written above.
ALNYLAM PHARMACEUTICALS, INC.
By: /s/ Xxxx X. Xxxxxxxxxx
------------------------------------
Name: Xxxx X. Xxxxxxxxxx
Title: President & Chief Executive
Officer
BIOGEN IDEC, INC.
By: /s/ Xxxxx X. Xxxxxx
------------------------------------
Name: Xxxxx X. Xxxxxx
Title: President & Chief Executive
Officer
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SCHEDULE A
[**] PATENT RIGHTS
[**]
PUBLICATION
COUNTRY TYPE APPLICATION NO. FILING DATE PUBLICATION NO. DATE PATENT NO. ISSUE DATE
------- ---- --------------- ----------- --------------- ----------- ---------- ----------
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**]
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SCHEDULE 9
EXCEPTIONS TO REPRESENTATIONS AND WARRANTIES
Section 9(a):
[**].
Section 9(b):
There are currently multi-party oppositions against the following European
patents included in Alnylam Patent Rights:
(i) Alnylam Europe AG European patent number 1144623. Amended claims for
this patent were upheld in the oral phase of the opposition
proceedings on June 21 and 22, 2006.
(ii) Alnylam Europe AG European patent number 1214945.
(iii) CRT European patent number 1230375.
A single party has also opposed Alnylam Europe AG Australian patent number
778474.
Section 9(c):
[**].
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