<PAGE>
EXECUTION COPY
Exhibit 10.1
Confidential Materials omitted and filed
separately with the Securities and exchange
Commission. Asterisks denote omissions.
COLLABORATION AGREEMENT
BY AND BETWEEN
ALNYLAM PHARMACEUTICALS, INC.
AND
MEDTRONIC, INC.
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ARTICLE 1
Definitions....................................................................
1
Section 1.1
Affiliate............................................................
1
Section 1.2
Alnylam
FTE Cost.....................................................
1
Section 1.3
Alnylam
Intellectual Property........................................
2
Section 1.4
Alnylam
Know-How.....................................................
2
Section 1.5
Alnylam
Patent Rights................................................
2
Section 1.6
Alnylam
siRNA........................................................
2
Section 1.7
Blocking
Third Party Intellectual Property...........................
2
Section 1.8
[**].................................................................
2
Section 1.9
Collaboration
Program................................................
2
Section 1.10
Collaboration
Term...................................................
2
Section 1.11
Commercialization or
Commercialize................................... 2
Section 1.12
Commercially Reasonable
Efforts...................................... 3
Section 1.13
Confidential
Information.............................................
3
Section 1.14
Control or
Controlled................................................
3
Section 1.15
Cover, Covering or
Covered........................................... 4
Section 1.16
CPI..................................................................
4
Section 1.17
Develop or
Development...............................................
4
Section 1.18
Development
Candidate................................................
4
Section 1.19
Device...............................................................
4
Section 1.20
Device-Related.......................................................
4
Section 1.21
Discover or
Discovery................................................
4
Section 1.22
[**].................................................................
4
Section 1.23
Exclusivity
Field....................................................
4
Section 1.24
Executive
Officers...................................................
4
Section 1.25
FDA..................................................................
5
Section 1.26
Field................................................................
5
Section 1.27
First Commercial
Sale................................................ 5
Section 1.28
GAAP.................................................................
5
Section 1.29
Gene
Target..........................................................
5
Section 1.30
Gross
Margin.........................................................
5
Section 1.31
IND..................................................................
5
Section 1.32
Joint Intellectual
Property.......................................... 5
Section 1.33
Joint
Know-How.......................................................
5
Section 1.34
Joint Patent
Rights..................................................
5
Section 1.35
JRDC
Representative..................................................
5
Section 1.36
Know-How.............................................................
5
Section 1.37
Licensed
Product.....................................................
6
Section 1.38
Listed Alnylam Third Party
Agreement................................. 6
Section 1.39
Major
Market.........................................................
6
Section 1.40 Manufacturing
Cost...................................................
6
Section 1.41
Medtronic
Device.....................................................
6
Section 1.42
Medtronic Intellectual
Property...................................... 6
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Section 1.43
Medtronic
Know-How...................................................
6
Section 1.44
Medtronic Patent
Rights.............................................. 6
Section 1.45
NDA..................................................................
6
Section 1.46
Net
Sales............................................................
7
Section 1.47
Neurodegenerative
Disease............................................ 7
Section 1.48
Party................................................................
7
Section 1.49
Patent
Rights........................................................
7
Section 1.50
PDP
Decision Milestone...............................................
8
Section 1.51
Person...............................................................
8
Section 1.52
Phase I
Study........................................................
8
Section 1.53
Phase II(a)
Study....................................................
8
Section 1.54
Phase II(b)
Study....................................................
8
Section 1.55
Phase III
Study......................................................
8
Section 1.56
Pivotal
Study........................................................
8
Section 1.57
Product..............................................................
8
Section 1.58
Product..............................................................
8
Section 1.59
Product Development
Program.......................................... 8
Section 1.60
Product Development
Term............................................. 8
Section 1.61
Regulatory
Approval..................................................
9
Section 1.62
Regulatory
Authority.................................................
9
Section 1.63
Royalty
Term.........................................................
9
Section 1.64
siRNA................................................................
9
Section 1.65
siRNA-Attributable
Portion........................................... 9
Section 1.66
siRNA Cost of
Goods..................................................
9
Section 1.67
Target
Indication....................................................
9
Section 1.68
Technology Development
Term.......................................... 9
Section 1.69
Territory............................................................
10
Section 1.70
Third
Party..........................................................
10
Section 1.71
Valid
Claim..........................................................
10
Section 1.72
Workplan.............................................................
10
Section 1.73
Additional
Definitions...............................................
10
ARTICLE 2 Collaboration
Program..........................................................
11
Section 2.1
General..............................................................
11
Section 2.2
JRDC.................................................................
11
Section 2.3
Management
of Collaboration Program..................................
12
Section 2.4
Decisionmaking.......................................................
16
Section 2.5
Term of
Collaboration Program........................................
17
Section 2.6
Exclusivity and Diligence
Obligations................................ 17
Section 2.7
[**]
Alnylam siRNAs Used In Collaboration Program Activities
for Which Alnylam has Primary
Responsibility......................... 19
Section 2.8
Supply of
Alnylam siRNAs to Medtronic................................
19
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ARTICLE 3 Grant of
Rights................................................................
19
Section 3.1
Alnylam
Grants.......................................................
19
Section 3.2
Medtronic
Covenant Not to Sue........................................
22
Section 3.3
Retained
Rights......................................................
22
ARTICLE 4 Financial
Provisions...........................................................
23
Section 4.1
Equity
Investments and Payments for Additional Product
Development
Programs.................................................
23
Section 4.2
Milestone
Payments for Product Development Programs..................
24
Section 4.3
Royalty
Payments.....................................................
24
Section 4.4
Duration
of Royalty Payments.........................................
25
Section 4.5
Royalties
Payable Only Once..........................................
25
Section 4.6
Reductions
to Section 4.2 and Section 4.3 Payments After Product
Development Program
Terminations..................................... 26
Section 4.7
Credits
Against Future Royalties.....................................
26
Section 4.8
Royalty
Reports and Accounting.......................................
26
Section 4.9
Currency
Exchange....................................................
27
Section 4.10
Tax
Withholding......................................................
27
Section 4.11
Late
Payments........................................................
27
ARTICLE 5 Intellectual Property Ownership,
Protection and Related Matters................ 28
Section 5.1
Ownership
of Inventions..............................................
28
Section 5.2
Prosecution and Maintenance of Patent
Rights......................... 29
Section 5.3
Third
Party Infringement.............................................
30
Section 5.4
Claimed
Infringement; Claimed Invalidity.............................
32
Section 5.5
Patent
Term Extensions...............................................
32
Section 5.6
Patent
Marking.......................................................
32
Section 5.7
Maintain
Licenses in Force...........................................
33
ARTICLE 6
Confidentiality................................................................
33
Section 6.1
Confidential
Information.............................................
33
Section 6.2
Disclosures to Employees, Consultants and
Advisors................... 34
Section 6.3
Term
................................................................
34
Section 6.4
Publicity............................................................
34
Section 6.5
Publications.........................................................
34
ARTICLE 7 Representations and
Warranties.................................................
35
Section 7.1
Representations of
Authority......................................... 35
Section 7.2
Consents.............................................................
35
Section 7.3
No
Conflict..........................................................
35
Section 7.4
Enforceability.......................................................
35
Section 7.5
Employee
Obligations.................................................
35
Section 7.6
Intellectual
Property................................................
36
Section 7.7
No
Warranties........................................................
36
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ARTICLE 8 Term and
Termination...........................................................
36
Section 8.1
Term.................................................................
36
Section 8.2
Termination For Material
Breach...................................... 36
Section 8.3
Termination Upon Termination of the Supply
Agreement................. 37
Section 8.4
Termination For
Convenience.......................................... 37
Section 8.5
Effect of
Termination................................................
38
Section 8.6
Survival.............................................................
40
ARTICLE 9 Miscellaneous
Provisions.......................................................
40
Section 9.1
Indemnification......................................................
40
Section 9.2
Governing
Law and Waiver of Jury Trial...............................
42
Section 9.3
Assignment...........................................................
42
Section 9.4
Amendments...........................................................
42
Section 9.5
Notices..............................................................
42
Section 9.6
Force
Majeure........................................................
43
Section 9.7
Independent
Contractors..............................................
43
Section 9.8
No Strict
Construction...............................................
44
Section 9.9
Headings.............................................................
44
Section 9.10
No
Implied Waivers; Rights Cumulative................................
44
Section 9.11
Severability.........................................................
44
Section 9.12
Execution in Counterparts; Facsimile
Signatures...................... 44
Section 9.13
No
Consequential or Punitive Damages.................................
44
Section 9.14
Interpretation.......................................................
44
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Schedule 1.5
Alnylam Patent Rights
Schedule 1.38
Listed Alnylam Third Party Agreements
Schedule 3.1(e) Burdens on
Alnylam Intellectual Property Imposed by
Existing Alnylam Contractual Obligations
Schedule 4.3(b) Medtronic
Financial Obligations With Respect to Listed
Alnylam Third Party Agreements
Exhibit A PDP Decision Milestone
Criteria
Exhibit B Form of
Initial Technology Development Program Workplan
Exhibit C Material
Terms of Investment Agreement
Exhibit D Initial
Press Release
Exhibit E Permitted
Disclosures
iv
<PAGE>
COLLABORATION AGREEMENT
This
Collaboration Agreement (the "Agreement") is entered into as of
the
8th day of February, 2005 (the "Effective
Date") by and between Alnylam
Pharmaceuticals, Inc., a corporation
organized and existing under the laws of
the State of Delaware and having its
principal office at 300 Third Street,
Cambridge, Massachusetts 02142 ("Alnylam"),
and Medtronic, Inc., a corporation
organized and existing under the laws of
the State of Minnesota and having its
principal office at 710 Medtronic Parkway,
Minneapolis, Minnesota 55432
("Medtronic").
INTRODUCTION
1. Alnylam
is engaged in the business of discovering and developing
siRNA-based therapeutics.
2.
Medtronic is engaged in the business of developing and
marketing
medical devices.
3. Alnylam
and Medtronic are interested in collaborating in the discovery,
development and commercialization of
siRNA-based therapeutics for the treatment
of certain diseases using implanted
infusion devices for the direct delivery of
siRNAs to the human nervous system.
NOW,
THEREFORE, in consideration of the respective representations,
warranties, covenants and agreements
contained herein, and for other valuable
consideration, the receipt and adequacy of
which are hereby acknowledged,
Alnylam and Medtronic agree as follows:
Article I
Definitions
When used in this Agreement, each of the
following terms shall have the meanings
set forth in this Article I:
Section
1.1 "Affiliate". Affiliate of a specified Person shall mean any
Person that controls, is controlled by, or
is under common control with such
Person. For purposes of this Section 1.1,
"control" shall mean (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.
Section
1.2 "Alnylam FTE Cost". Alnylam FTE Cost shall mean the product
obtained by multiplying (a) the number of
full-time-equivalent person-years
(each consisting of a total of [**]) of
scientific, technical or managerial work
by Alnylam personnel on or directly related
to the Product Development Program
by (b) an annual cost per
full-time-equivalent person-year to be agreed by the
Parties in connection with the
Proceed-to-PDP Determination, increased or
decreased annually by the percentage
increase or decrease in the CPI as of
December 31 of the
<PAGE>
then most recently ended calendar year over
the level of the CPI on December 31
of the calendar year most recently ended
prior to the Proceed-to-PDP
Determination (i.e., the first such
increase or decrease would occur on January
1 of the calendar year following the
calendar year in which the Proceed-to-PDP
Determination occurs).
Section
1.3 "Alnylam Intellectual Property". Alnylam Intellectual
Property shall mean Alnylam Know-How and
Alnylam Patent Rights, collectively.
Section
1.4 "Alnylam Know-How". Alnylam Know-How shall mean any
Know-How,
other than Joint Know-How, that (a) either
(i) is in Alnylam's possession on the
Effective Date or (ii) Alnylam develops or
acquires during the Collaboration
Term, (b) is useful to Discover, Develop
and Commercialize Alnylam siRNAs and/or
Licensed Products, and (c) is Controlled by
Alnylam or used by Alnylam in the
Collaboration Program.
Section
1.5 "Alnylam Patent Rights". Alnylam Patent Rights shall mean
Patent Rights Controlled by Alnylam
Covering Alnylam Know-How, including those
set forth on Schedule 1.5, but excluding
Joint Patent Rights.
Section
1.6 "Alnylam siRNA". Alnylam siRNA shall mean any siRNA (a) the
Discovery, Development, manufacture,
Commercialization or other use of which
uses Alnylam Know-How or Joint Know-How or
is Covered by Alnylam Patent Rights
or Joint Patent Rights and (b) made
available or approved by Alnylam for
Development in the Collaboration
Program.
Section
1.7 "Blocking Third Party Intellectual Property". Blocking
Third
Party Intellectual Property shall mean, on
a Licensed Product-by-Licensed
Product and country-by-country basis, Valid
Claims that (a) are not Controlled
by Alnylam and not Controlled as of the
Effective Date by Medtronic and (b)
Cover an siRNA contained in or used in such
Licensed Product in such country.
For the avoidance of doubt, Valid Claims
Controlled by Alnylam under a [**]
shall not constitute Blocking Third Party
Intellectual Property.
Section
1.8 "[**] shall mean, with respect to an Alnylam siRNA included
in a Product Development Program,
achievement of [**] agreed by the Parties
pursuant to Sections 2.3(c)(i), 2.3(c)(iii)
and 2.3(c)(iv) as constituting
reasonable evidence of [**].
Section
1.9 "Collaboration Program". Collaboration Program shall mean
the
research and development program to be
performed by the Parties pursuant to this
Agreement to develop Licensed Products,
consisting of the Technology Development
Program and the Product Development
Program(s).
Section
1.10 "Collaboration Term". Collaboration Term shall mean the
period commencing on the Effective Date and
ending on the earliest of (a) the
end of the Technology Development Term,
[**] (b) the end of all Product
Development Terms, (c) the date (if any) on
which the Collaboration Term is
terminated by mutual written agreement of
the Parties, and (d) the date of
termination of this Agreement in accordance
with the provisions hereof.
Section
1.11 "Commercialization" or "Commercialize". Commercialization
or
Commercialize shall mean any activities
directed to marketing, promoting,
distributing,
2
<PAGE>
importing, offering to sell, and/or selling
a product, whether before or after
Regulatory Approval for such product has
been obtained.
Section
1.12 "Commercially Reasonable Efforts". Commercially Reasonable
Efforts shall mean the efforts, expertise
and resources normally used by a Party
to Discover, Develop and Commercialize a
product or compound owned by it or to
which it has rights, which is of similar
market potential at a similar stage in
its development or product life, taking
into account issues of safety and
efficacy, product profile, difficulty in
developing the product or compound,
competitiveness of the marketplace for the
product, the proprietary position of
the compound or product, the regulatory
structure involved, the availability and
level of reimbursement for such treatment
by third party payors or health
insurance plans, the potential total
profitability of the applicable product(s)
marketed or to be marketed and other
relevant factors affecting the cost, risk
and timing of Development and the total
potential reward to be obtained if a
product is Commercialized. The Parties
agree that Commercially Reasonable
Efforts shall not require a Party to expend
efforts, expertise and resources
that such Party would not normally expend
to Discover, Develop and Commercialize
a product or compound owned by it or to
which it has rights, taking into account
the foregoing factors.
Section
1.13 "Confidential Information". Confidential Information shall
mean all Know-How or other information that
is of a confidential and proprietary
nature to a Party. Confidential Information
includes Know-How or other
information (whether or not patentable)
regarding a Party's technology,
products, business information or
objectives and reports and audits under
Section 4.8, and all biological materials
of a Party. Notwithstanding the
foregoing, Confidential Information shall
not include Know-How or other
information that:
(a) was known or used by the receiving Party or its Affiliates
prior
to its date of disclosure to the receiving
Party as demonstrated by
contemporaneous written records; or
(b) 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 such
Know-How or other information and not bound
by confidentiality obligations to
the disclosing Party; or
(c) either before or after the date of the disclosure to the
receiving Party or its Affiliates is or
becomes published or otherwise is or
becomes part of the public domain through
no breach hereof on the part of the
receiving Party or its Affiliates; or
(d) is independently developed by or for the receiving Party or
its
Affiliates without reference to or reliance
upon the Confidential Information of
the disclosing Party as demonstrated by
contemporaneous written records.
Section
1.14 "Control" or "Controlled". Control or Controlled, with
respect to any (a) Know-How or other
information or materials or (b)
intellectual property right, shall mean the
possession (whether by license or
ownership) by a Party of the ability to
grant to the other Party access and/or a
license as provided herein without
violating the terms of any agreement with any
Third Party existing as of the Effective
Date or thereafter during the term of
this Agreement.
3
<PAGE>
Section
1.15 "Cover", "Covering" or "Covered". Cover, Covering or
Covered, with respect to a product or
technology, shall mean that, but for a
license granted to a Person under a Valid
Claim included in the Patent Rights
under which such license is granted, the
Discovery, Development, manufacture,
Commercialization and/or other use of such
product or practice of such
technology by such Person would infringe
such Valid Claim.
Section
1.16 "CPI". CPI shall mean the Consumer Price Index - Urban
Wage
Earners and Clerical Workers, U.S. City
Average, All Items, 1982-84 = 100,
published by the United States Department
of Labor, Bureau of Labor Statistics
(or its successor equivalent index) in the
United States.
Section
1.17 "Develop" or "Development". Develop or Development shall
mean preclinical and clinical siRNA and/or
Device development activities,
including test method development and
stability testing, Device design,
siRNA-Device compatibility testing,
toxicology, animal efficacy studies,
formulation, quality assurance/quality
control development, statistical
analysis, clinical studies, regulatory
affairs, product approval and
registration.
Section
1.18 "Development Candidate". Development Candidate shall mean
an
Alnylam siRNA that is designated as a
Development Candidate in connection with a
[**] or thereafter designated as a
Development Candidate by mutual agreement of
the Parties.
Section
1.19 "Device". Device shall mean any implanted infusion device
for delivery of therapeutics to the human
nervous system.
Section
1.20 "Device-Related". Device-Related, with respect to Know-How
or Patent Rights, shall mean relating
specifically to the design or physical
features of a Device, any [**] a Device
(excluding [**]), any hardware component
of a Device, any software that controls a
Device and/or any associated medical
devices or accessories, such as [**], and
any use or implantation of any of the
foregoing, but not relating specifically to
an siRNA ([**]) to be delivered by
such Device.
Section
1.21 "Discover" or "Discovery". Discover or Discovery shall
mean
any activities conducted to discover and
characterize siRNAs as potential
therapeutics in the Field and to support
the designation of the same as
Development Candidates in connection with
the Proceed-To-PDP Determination or
thereafter in connection with an Additional
Product Development Program.
Section
1.22 "[**]". [**]shall mean an [**] produced [**].
Section 1.23
"Exclusivity Field". Exclusivity Field, with respect to a
[**], shall mean the treatment of Target
Indications for which a Licensed
Product is to be Commercialized, using
Devices for the direct delivery of siRNAs
to the human nervous system [**].
Notwithstanding the foregoing, (a) the
Exclusivity Field shall not include [**]
and (b) the term `direct delivery to
the human nervous system' does not
encompass [**].
Section
1.24 "Executive Officers". Executive Officers shall mean
Medtronic's Senior Vice President of
Medicine and Technology (or the officer or
employee of Medtronic then
4
<PAGE>
serving in a substantially equivalent
capacity) and Alnylam's Chief Operating
Officer (or the officer or employee of
Alnylam then serving in a substantially
equivalent capacity).
Section
1.25 "FDA". FDA shall mean the United States Food and Drug
Administration.
Section
1.26 "Field". Field shall mean the treatment of
Neurodegenerative
Diseases using Devices for the direct
delivery of siRNAs to the human nervous
system[**], it being understood that
"direct delivery to the human nervous
system" does not encompass [**]. For the
avoidance of doubt, the parties agree
that treatment of a Neurodegenerative
Disease does not include [**].
Notwithstanding the foregoing, the Field
shall not include [**].
Section
1.27 "First Commercial Sale". First Commercial Sale, with
respect
to a Licensed Product, shall mean the first
commercial sale of such Licensed
Product by Medtronic, its Affiliates,
distributors and/or agents. Sales for test
marketing or clinical trial purposes shall
not constitute a First Commercial
Sale.
Section
1.28 "GAAP". GAAP shall mean then current United States
generally
accepted accounting principles,
consistently applied.
Section
1.29 "Gene Target". Gene Target shall mean [**].
Section
1.30 "Gross Margin". Gross Margin, with respect to a Licensed
Product, shall mean: (a) (i) the Net Sales
of such Licensed Product for the
applicable time period, times (ii) the [**]
of such Licensed Product, less (b)
the [**] of such Licensed Product.
Section
1.31 "IND". IND means an application submitted to a Regulatory
Authority to initiate human clinical
trials, including (a) an Investigational
New Drug application or any successor
application or procedure filed with the
FDA, (b) except where otherwise
specifically provided in this Agreement, any
foreign equivalent of a U.S.
Investigational New Drug application, and (c) all
supplements and amendments that may be
filed with respect to the foregoing.
Section
1.32 "Joint Intellectual Property". Joint Intellectual Property
shall mean Joint Know-How and Joint Patent
Rights, collectively.
Section
1.33 "Joint Know-How". Joint Know-How shall mean any Know-How
that is developed or acquired jointly by
the Parties in the course of the
Collaboration Program, excluding [**].
Section
1.34 "Joint Patent Rights". Joint Patent Rights shall mean
Patent
Rights that Cover Joint Know-How.
Section
1.35 "JRDC Representative". JRDC Representative shall mean a
Party's representative designated by such
Party to serve on the JRDC pursuant to
Section 2.2.
Section
1.36 "Know-How". Know-How shall mean any tangible or intangible
know-how, expertise, discoveries,
inventions, information, data or materials,
including ideas, concepts,
5
<PAGE>
formulas, methods, procedures, designs,
technologies, compositions, plans,
applications, technical data, samples,
chemical compounds and biological
materials and all derivatives,
modifications and improvements thereof.
Section
1.37 "Licensed Product". Licensed Product shall mean a Product
within the Field that includes, as an
active pharmaceutical ingredient, an
Alnylam siRNA for delivery via a Medtronic
Device.
Section
1.38 "Listed Alnylam Third Party Agreement". Listed Alnylam
Third
Party Agreement shall mean any agreement
listed on Schedule 1.38.
Section
1.39 "Major Market". Major Market shall mean any of [**].
Section
1.40 "Manufacturing Cost". Manufacturing Cost, with respect to
the
manufacture and/or supply of Alnylam siRNAs
for incorporation into Licensed
Products, shall mean (a) if either Party or
an Affiliate of either Party
manufactures such Alnylam siRNAs, such
Party's and/or its Affiliates' aggregate
manufacturing costs, which aggregate costs
shall consist of (i) internal and
out-of-pocket costs of raw materials, labor
and other variable costs directly
incurred in the manufacture of such Alnylam
siRNAs and (ii) reasonable and
appropriate allocations (excluding [**])
pursuant to GAAP of Alnylam siRNA
manufacturing overhead costs, or (b) if
[**] to a Third Party, such Party's
aggregate internal and out-of-pocket costs
of procuring such [**] from the Third
Party, testing such [**] and putting such
[**].
Section
1.41 "Medtronic Device". Medtronic Device shall mean any Device
sold by Medtronic.
Section
1.42 "Medtronic Intellectual Property". Medtronic Intellectual
Property shall mean Medtronic Know-How and
Medtronic Patent Rights,
collectively.
Section
1.43 "Medtronic Know-How". Medtronic Know-How shall mean any
Know-How, other than Joint Know-How and
Know-How related to [**] siRNAs, that
(a) either (i) is in Medtronic's possession
on the Effective Date or (ii)
Medtronic develops or acquires during the
Collaboration Term, (b) is useful to
Discover, Develop and Commercialize Alnylam
siRNAs and/or Licensed Products, and
(c) is Controlled by Medtronic or used by
Medtronic in the Collaboration
Program.
Section
1.44 "Medtronic Patent Rights". Medtronic Patent Rights shall
mean
Patent Rights Controlled by Medtronic
Covering Medtronic Know-How, but excluding
Joint Patent Rights.
Section
1.45 "NDA". NDA shall mean an application submitted to a
Regulatory Authority for marketing approval
of a product, including (a) a New
Drug Application, Product License
Application or Biologics License Application
filed with FDA or any successor
applications or procedures, (b) a foreign
equivalent of a U.S. New Drug Application,
Product License Application or
Biologics License Application or any
successor applications or procedures, and
(c) all supplements and amendments that may
be filed with respect to the
foregoing.
6
<PAGE>
Section
1.46 "Net Sales". Net Sales, with respect to a particular
Licensed
Product in a particular period, shall mean
the gross amount invoiced by
Medtronic, its Affiliates and/or its
sublicensees on sales or other dispositions
(excluding sales or dispositions for use in
clinical trials or other scientific
testing, in either case for which Medtronic
receives no revenue) of the Licensed
Product to unrelated Third Parties during
such period, less the following
deductions:
(a) Trade, cash and quantity discounts actually allowed and
taken
directly with respect to such sales or
other dispositions;
(b) Tariffs, duties, excises, sales taxes or other taxes
imposed
upon and paid directly with respect to the
delivery, sale or use of the Licensed
Product and included and separately stated
in the applicable invoice (excluding
national, state or local taxes based on
income);
(c) Amounts repaid or credited by reason of rejections,
defects,
recalls or returns or because of reasonable
and customary chargebacks, refunds,
rebates or retroactive price
reductions;
(d) Amounts previously included in Net Sales of Licensed
Products
that are written-off by Medtronic as
uncollectible in accordance with
Medtronic's standard practices for writing
off uncollectible amounts
consistently applied; provided that if any
such written-off amounts are
subsequently collected, such collected
amounts shall be included in Net Sales in
the period in which they are subsequently
collected; and
(e) Freight, insurance and other transportation charges incurred
in
shipping a Licensed Product to Third
Parties, included and separately stated in
the applicable invoice.
Such amounts shall, subject to the
provisions of Sections 4.8 and 4.9, be
determined from the books and records of
Medtronic, its Affiliates and/or its
sublicensees, maintained in accordance with
GAAP, consistently applied.
Section
1.47 "Neurodegenerative Disease". Neurodegenerative Disease
shall
mean a disease of the brain and/or spinal
cord in humans that is characterized
by the chronic and progressive death of
neurons which leads to the loss of
normal neural function. Such diseases
include, but are not limited to,
Parkinson's disease, Huntington's disease,
Alzheimer's disease, and amyotrophic
lateral sclerosis. For the avoidance of
doubt, Neurodegenerative Disease shall
not include [**].
Section
1.48 "Party". Party shall mean Alnylam or Medtronic; "Parties"
shall mean Alnylam and Medtronic. As used
in this Agreement, references to
"Third Parties" do not include a Party or
its Affiliates.
Section
1.49 "Patent Rights". Patent Rights shall mean United States
and
foreign patents, patent applications and/or
provisional patent applications,
utility models and utility model
applications, design patents or registered
industrial designs and design applications
or applications for registration of
industrial designs, and all substitutions,
divisionals, continuations,
continuation-in-part applications,
continued prosecution applications, reissues,
reexaminations and extensions thereof.
7
<PAGE>
Section
1.50 "PDP Decision Milestone". PDP Decision Milestone shall
mean
the satisfaction of the criteria set forth
in Exhibit A with respect to [**]
Alnylam siRNA.
Section
1.51 "Person". Person shall mean any corporation, limited or
general partnership, limited liability
company, joint venture, trust,
unincorporated association, governmental
body, authority, bureau or agency, any
other entity or body, or an individual.
Section
1.52 "Phase I Study". Phase I Study shall mean a study of an
siRNA
or Product in human volunteers or patients
the purpose of which is preliminary
determination of safety and tolerability of
a dosing regime and for which there
are no primary endpoints (as recognized by
FDA or other Regulatory Authorities)
in the protocol relating to efficacy.
Section
1.53 "Phase II(a) Study". Phase II(a) Study shall mean a
preliminary efficacy and safety study of an
siRNA or Product in the target
patient population designed to demonstrate
Clinical Proof of Concept.
Section
1.54 "Phase II(b) Study". Phase II(b) Study shall mean a study
of
an siRNA or Product to evaluate further any
preliminary efficacy observed for,
and the safety of, the siRNA or Product in
the target patient population and/or
to provide data that may be useful in the
design of subsequent studies of the
siRNA or Product such as Phase III Studies
or Pivotal Studies.
Section
1.55 "Phase III Study". Phase III Study shall mean a controlled
study to confirm with statistical
significance the efficacy and safety of an
siRNA or Product performed to obtain
marketing and/or manufacturing approval for
the product in any country.
Section
1.56 "Pivotal Study". Pivotal Study shall mean a human clinical
study, including any Phase III Study, the
results of which, if the study
endpoints are met, would provide data
necessary to support Regulatory Approval
for a Licensed Product in a Major Market. A
Pivotal Study shall be deemed to
have commenced when the first patient has
been dosed in such study or, in the
case of a study determined to meet the
criteria of a Pivotal Study as set forth
above after the first patient has been
dosed, when such study is determined to
meet such criteria.
Section
1.57 "Primary Sequence or Chemical Modification Know-How".
Primary
Sequence or Chemical Modifications Know-How
shall mean information about the
primary sequence of any siRNA or chemical
modifications incorporated into any
siRNA.
Section
1.58 "Product". Product shall mean a human therapeutic product
that includes siRNA(s) as active
pharmaceutical ingredient(s) delivered or
approved for delivery via a Device.
Section
1.59 "Product Development Program". Product Development Program
shall mean the Initial Product Development
Program and any Additional Product
Development Program(s).
Section
1.60 "Product Development Term". Product Development Term, with
respect to a Product Development Program,
shall mean the period commencing on
(a) with respect to the Initial Product
Development Program, the date on which a
Proceed-to-PDP Determination is made, and
(b) with respect to each Additional
Product Development Program, the date on
which the Parties mutually agree to
commence such Product Development Program
in accordance with
8
<PAGE>
Section 2.3(c)(iii), and, subject to [**],
ending on the earliest date on which
at least one Licensed Product for the
treatment of each Target Indication
designated for such Product Development
Program has been commercially launched.
Section
1.61 "Regulatory Approval". Regulatory Approval shall mean the
approval of the applicable Regulatory
Authority necessary for the marketing and
sale of a Licensed Product for a particular
indication in a country, excluding
separate pricing and/or reimbursement
approvals that may be required.
Section
1.62 "Regulatory Authority". Regulatory Authority shall mean a
federal, national, multinational, state,
provincial or local regulatory agency,
department, bureau or other governmental
entity with authority over the testing,
manufacture, use, storage, import,
promotion, marketing or sale of a Product in
a country or territory.
Section
1.63 "Royalty Term". Royalty Term, with respect to each
Licensed
Product in each country of the Territory,
shall mean the period of time ending
on the latest date on which the
manufacture, use or sale of such Licensed
Product in such country is Covered by a
Valid Claim of Alnylam Patent Rights.
Section
1.64 "siRNA". siRNA means a composition designed to act
primarily
through an RNAi mechanism which 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.
Section
1.65 "siRNA-Attributable Portion". siRNA-Attributable Portion,
with respect to any Licensed Product, shall
mean the proportion of the end user
price of[**]such Licensed Product
attributable, as determined jointly by both
Parties, to the Alnylam siRNA(s)
incorporated in such Licensed Product (as
compared to the Medtronic Device
incorporated in such Licensed Product), which
determination shall be made by the Parties
prior to [**]. In making such
determination, the Parties shall consider
[**], as well as any other factors
that the Parties may find relevant to such
determination.
Section
1.66 "siRNA Cost of Goods". siRNA Cost of Goods, with respect to
a
Licensed Product, shall mean (a) either (i)
Manufacturing Cost amounts [**], or
(ii) if Medtronic [**], Manufacturing Cost
amounts incurred by [**] incorporated
into the Licensed Product, and (b)
additional amounts attributable to the
Licensed Product reimbursable by [**]).
Section
1.67 "Target Indication". Target Indication, with respect to an
Alnylam siRNA, shall mean each human
disease or condition that is designated as
a Target Indication with respect to such
Alnylam siRNA in accordance with
Section 2.3(c)(i) or 2.3(c)(iii).
Section
1.68 "Technology Development Term". Technology Development Term
shall mean the period commencing on the
Effective Date and, subject to early
termination pursuant to Section 2.3(e) or
2.3(f), ending on the earlier of (a)
the date on which either Party notifies the
other Party that such Party [**] or
(b) the [**] anniversary of the Effective
Date (or, if the Parties have, prior
to the date of such
9
<PAGE>
[**] anniversary, elected to extend the
Technology Development Term, then the
date of expiration of such extension).
Section
1.69 "Territory". Territory shall mean, subject to Section
8.2(b),
all countries of the world.
Section
1.70 "Third Party". Third Party shall mean any Person other
than
Alnylam or Medtronic and their respective
Affiliates.
Section
1.71 "Valid Claim". Valid Claim shall mean a claim (a) of any
issued, unexpired patent that has not been
revoked or held unenforceable or
invalid by a decision of a court or
governmental agency of competent
jurisdiction from which no appeal can be
taken, or with respect to which an
appeal is not taken within the time allowed
for appeal, and that has not been
disclaimed or admitted to be invalid or
unenforceable through reissue,
disclaimer or otherwise, or (b) of any
published patent application that has not
been cancelled, withdrawn or abandoned, nor
been pending for more than seven (7)
years from the filing date of the earliest
patent application from which such
patent application claims priority.
Section
1.72 "Workplan". Workplan shall mean a work plan describing the
activities to be undertaken during each
phase of the Collaboration Program, as
adopted, updated or amended pursuant to
Section 2.3, including during the
Technology Development Program, the Initial
Product Development Program
(consisting of the [**] Development
Program[**] Development Program) and each
Additional Product Development Program.
Section
1.73 Additional Definitions. Each of the following definitions
is
set forth in the section of this Agreement
indicated below:
<TABLE>
<CAPTION>
Definition
Section
-----------------------------------------
----------------
<S>
<C>
"Additional Product Development Program"
2.3(c)(iii)
"Agreement"
Preamble
"Alnylam"
Preamble
"Alnylam Discontinuation Notice"
2.3(e)
"Alnylam Indemnified Parties"
9.1(a)
"Breaching Party"
8.2(a) or 8.2(c)
"[**] Development Program"
2.3(c)(i)
"[**] Development Program Workplan"
2.3(c)(i)
"[**] Development Program"
2.3(c)(ii)
"[**] Development Program Workplan"
2.3(c)(ii)
"Device Inventions"
5.1(b)
"Effective Date"
Preamble
"Electing Party"
5.2(c)
"Exclusive Negotiation Period"
2.6(e)(ii)
"First Equity Investment"
Exhibit C
---------
"Indemnified Party"
9.1(c)
"Indemnifying Party"
9.1(c)
"Initial Product Development Program"
2.3(c)(i)
"Invalidity Claim"
5.4(c)
</TABLE>
10
<PAGE>
<TABLE>
<S>
<C>
"Investment Agreement"
4.1(a)
"Jointly Developed Inventions"
5.1(c)
"JRDC"
2.2
"KOL Panel"
2.3(c)(iv)
"Losses"
9.1(a)
"Mayo"
2.6(a)
"Medtronic"
Preamble
"Medtronic Discontinuation Notice"
2.3(f)
"Medtronic Indemnified Parties"
9.1(b)
"Non-Breaching Party"
8.2(a) or 8.2(c)
"Non-Electing Party"
5.2(c)
"Pre-IND PDP Termination"
2.3(e)
"Pre-Phase I PDP Termination"
2.3(e)
"Pre-PoC PDP Termination"
2.3(e)
"Pre-Tox PDP Termination"
2.3(e)
"Proceed-to-PDP Determination"
2.3(c)(i)
"Program Data"
5.1(e)
"Right of Access"
5.1(e)
"RoFN Notice"
2.6(e)(i)
"RoFN Offer"
2.6(e)(iii)
"RoFN Opportunity"
2.6(e)
"RoFN Response Notice"
2.6(e)(i)
"RoFN Response Period"
2.6(e)(i)
"SEC"
6.1
"Second Equity Investment"
Exhibit C
---------
"Severed Clause"
9.11
"Sole Inventions"
5.1(c)
"Supply Agreement"
2.8
"Technology Development Program"
2.3(b)
"Technology Development Program Workplan"
2.3(b)
"Third Equity Investment"
Exhibit C
---------
"Third Party Infringement Claim"
5.4(a)
</TABLE>
Article II
Collaboration Program
Section
2.1 General. Pursuant to the terms of this Agreement, the
Parties
have agreed to collaborate on the
Discovery, Development, manufacture and
Commercialization of Licensed Products. The
objective of the Collaboration
Program is to Discover and Develop Licensed
Products. Both Parties will be
engaged in the conduct of the Collaboration
Program, and shall be responsible
for various Collaboration Program
activities as set forth in this Agreement.
Section
2.2 JRDC. The Parties shall establish a Joint Research and
Development Committee (the "JRDC"),
comprised of three (3) JRDC Representatives
designated by Alnylam and three (3) JRDC
Representatives designated by
Medtronic, each of which JRDC
Representatives shall be of the seniority and
experience appropriate for service on the
JRDC in
11
<PAGE>
light of the functions, responsibilities
and authority of the JRDC. Each Party
shall make its designation of its JRDC
Representatives not later than thirty
(30) days after the Effective Date. The
JRDC shall meet within thirty (30) days
after the Effective Date and, thereafter,
at least quarterly until the end of
the Collaboration Term, to (a) review the
efforts of the Parties in the conduct
of the Collaboration Program, (b) review
and, subject to Section 2.4, approve
proposed updates and amendments to the
Workplan, (c) consider and determine
whether [**] and (d) otherwise oversee and
direct the Collaboration Program
activities undertaken hereunder. For the
avoidance of doubt, neither the JRDC
nor any of its members has the authority to
make the [**] without written
authorization by each Party's Executive
Officer. The location of such meetings
of the JRDC shall alternate between
Minneapolis, MN and Cambridge, MA, unless
otherwise agreed by the JRDC. The JRDC may
also meet by means of a telephone or
video conference call, and may take action
by vote at a meeting or telephone or
video conference call, or pursuant to a
written vote. Each Party may change any
one or more of its JRDC Representatives at
any time upon written notice to the
other Party. Each Party shall use
Commercially Reasonable Efforts to cause its
JRDC Representatives to attend the meetings
of the JRDC. If a Party's JRDC
Representative is unable to attend a
meeting, such Party may designate an
alternate to attend such meeting in place
of the absent JRDC Representative. In
addition, each Party may, at its
discretion, invite non-voting employees, and,
with the consent of the other Party,
consultants or scientific advisors
(provided they are engaged as such under
obligations of confidentiality) to
attend the meetings of the JRDC. The JRDC
shall be dissolved and its activities
and authority terminated at the end of the
Collaboration Term.
Section 2.3 Management of
Collaboration Program.
(a) Workplan. The Parties shall undertake the specific
Collaboration
Program activities in accordance with the
relevant Workplan. Any JRDC
Representative may, at any time or from
time to time, submit any proposed
additions, updates or amendments to the
Workplan to the JRDC for its review. Any
such additions, updates or amendments shall
not become effective until approved
in writing by the JRDC, and, in the case of
the initial adoption of a new
Workplan or a material addition, update or
amendment to an existing Workplan or
a significant change in the target date for
completion of an activity in an
existing Workplan, approved in writing by
each Party's Executive Officer. The
JRDC shall review and consider any such
proposed Workplans, additions, updates
or amendments on an expeditious basis, and
all such Workplans, additions,
updates and amendments approved as set
forth above shall, subject to Section
2.4, constitute and be deemed part of this
Agreement for all purposes and
incorporated herein.
(b) Technology Development Program. During the Technology
Development Term, Alnylam will lead, and
Medtronic will cooperate with Alnylam
with respect to, a program (the "Technology
Development Program") whose goal is
to achieve the [**]; provided that
Medtronic will lead, and Alnylam will
cooperate with Medtronic with respect to,
all Technology Development Program
activities relating directly to the design,
configuration, assembly, filling or
re-filling of Devices. Alnylam shall be
responsible for [**] the Technology
Development Program for siRNA Discovery and
Development and Medtronic shall be
responsible for [**] the Technology
Development Program for Device Development;
provided that Medtronic shall be
responsible for [**] the Technology Development
Program [**] performed during such studies,
where such [**] to be agreed by the
Parties and specified in the applicable
Workplan. The Technology Development
Program will be conducted in accordance
with a Workplan to be
12
<PAGE>
mutually agreed to by the Parties within
forty-five (45) days after the
Effective Date, in substantially the form
attached as Exhibit B (the "Technology
Development Program Workplan"), which shall
initially address, in reasonable
detail, the roles and responsibilities of
each Party with respect to (i) the
design and identification of Alnylam siRNAs
[**], (ii) the assessment of such
Alnylam siRNAs [**] as potential
Development Candidates and (iii) the evaluation
of Devices, or prototypes thereof[**] to
determine their compatibility with, and
suitability to deliver, Alnylam siRNAs. The
JRDC shall monitor the progress of
the Technology Development Program on a
regular basis, and shall be responsible
for determining if and when the [**] has
been achieved with respect to [**]
Alnylam siRNA.
(c) Product Development Program.
(i) First Development Candidate. Following a determination by
the JRDC that the [**] has been achieved,
each Party shall determine whether it
desires to continue the Collaboration
Program by initiating the Initial Product
Development Program (as defined below) with
respect to a first Alnylam siRNA. If
both Parties desire to so continue, the
Parties shall discuss which Alnylam
siRNA will initially be designated as the
first Development Candidate for such
Initial Product Development Program, or
what further work may be required before
designating an Alnylam siRNA as such
Development Candidate, and what
indication(s) to designate as Target
Indication(s) for such Development
Candidate, which Target Indication(s) shall
be [**] corresponding to the Alnylam
siRNA(s) to be included in the Initial
Product Development Program. If the
Parties reach a preliminary agreement upon
such designations of a Development
Candidate (or work required prior to making
such designation) and Target
Indication(s), the Parties shall negotiate
a new Workplan (the [**]Development
Program Workplan" and the portion of the
Initial Product Development Program
covered by such new Workplan the "[**]
Development Program") in accordance with
Section 2.3(a), which shall (A) include
plans and budgets for the designation,
if still pending, and Development of such
Development Candidate for the
designated Target Indication(s), (B)
specify the responsibilities of each Party
in performing clinical study activities,
such as filing INDs with Regulatory
Authorities, the selection of centers,
negotiation and execution of clinical
agreements, training, monitoring, data
collection, notice of adverse events and
other regulatory requirements and (C) agree
upon [**] for the Initial Product
Development Program, and to the extent
reasonably feasible at the time such
Workplan is prepared, on [**]; provided
that to the extent it is not reasonably
feasible at the time such Workplan is
prepared to specify [**] for the Initial
Product Development Program, the [**] shall
be subject to the approval of both
Parties, or by [**] in the absence of such
joint approval, prior to [**], which
approval determinations shall be based
solely on [**]t. The Parties acknowledge
that in the course of the Initial Product
Development Program, the Parties (but
not the JRDC) may modify the [**] for the
Initial Product Development Program,
and [**], by amending the relevant Workplan
as set forth in Section 2.3(a) to
reflect such modification(s). The mutual
agreement of the Parties to proceed
with implementation of such [**]
Development Program Workplan and the Parties'
execution of the Investment Agreement shall
constitute the Parties'
determination (the "Proceed-to-PDP
Determination") to commence and carry out a
program (the "Initial Product Development
Program") for the Development of such
Development Candidate as a Licensed Product
for the treatment of the Target
Indication(s), a primary goal of which
shall be to achieve Regulatory Approval
of such Licensed Product for the treatment
of such Target Indication(s).
13
<PAGE>
(ii) Workplans. The [**] Development Program Workplan
negotiated by the Parties prior to the
Proceed-to-PDP Determination shall
specify that [**]; provided that Medtronic
will lead, and Alnylam will cooperate
with Medtronic with respect to all Product
Development Program activities (i)
relating directly to the design,
configuration, assembly, filling or re-filling
of Devices, [**] Product Development
Program [**]y. Alnylam shall be responsible
for [**] to the designated Development
Candidate in the course of the [**]
Development Program activities assigned to
it pursuant to the [**] Development
Program Workplan (including the [**];
provided that, if a [**] is achieved is
designed with the intention that [**] may
be determined based on an [**], then
Alnylam shall [**]and Medtronic shall be
responsible for all subsequent costs of
such clinical study[**] and Medtronic shall
[**] [**] Development Program [**].
Following the achievement of [**], the
Parties shall, subject to any early
termination of the Initial Product
Development Program, adopt additional
Workplan(s) to cover further Development of
the designated Development Candidate
and of applicable Devices (each such
additional Workplan, a "[**] Development
Program Workplan" and the portions of the
Initial Product Development Program
covered by each such additional Workplan,
collectively, the "[**] Development
Program"). Medtronic shall be responsible
for [**]Development Program. Each [**]
Development Program Workplan shall specify
as appropriate, in all requisite
detail, [**] in connection with any
activities to be performed by Alnylam
pursuant to [**] Development Program
Workplan. In connection with such
activities, Medtronic shall [**] through
the Supply Agreement as described in
Section 2.8, (y) [**] in accordance with
the [**] Development Program Workplan,
and (z) the [**] internal resources used by
Alnylam in accordance with the [**]
Development Program Workplan.
Notwithstanding the foregoing, Medtronic shall
[**] Alnylam's JRDC Representatives
performing JRDC responsibilities or by
Alnylam employees or agents for activities
not assigned to Alnylam in the [**]
Development Program Workplan [**] in
accordance with Section 2.3(b)).
(iii) Additional Product Development Programs. At any time
during the Collaboration Term, the Parties
may mutually agree (w) to initiate
additional program(s) (each, an "Additional
Product Development Program") to
Discover and Develop additional Alnylam
siRNA(s), Development Candidate(s) and
Licensed Product(s), (x) to adopt
additional Workplan(s) for any such Additional
Product Development Program(s), including
[**] in connection with any activities
performed by Alnylam with respect to such
Additional Product Development
Program(s), (y) on the Target Indication(s)
for Alnylam siRNA(s) within each
such Additional Product Development
Program, [**] for each such Additional
Product Development Program, and to the
extent reasonably feasible at the time
any such Workplan is prepared, on [**]
(provided that to the extent it is not
reasonably feasible at the time such
Workplan is prepared to specify [**] for
such Additional Product Development
Program, the [**] shall be subject to the
approval of both Parties, or [**] in the
absence of such joint approval, prior
to [**], which approval determinations
shall be based solely on [**]), and (z)
pursuant to Section 4.1(b), on [**] prior
to achievement of [**] in such
Additional Development Program(s) in [**]
to such Additional Development
Program(s). Additional Development relating
to [**] a Product Development
Program separate from an existing Product
Development Program in which such
siRNA is Developed for [**]; provided that
all such additional Development shall
be [**].
(iv) Determination of [**]. If the Parties are unable to agree
on (A) the [**] any Product Development
Program, (B) [**] or (C) [**] in any
Product Development Program, then, in
either case, the Parties shall submit such
dispute to [**]. One member of any
14
<PAGE>
[**] shall be nominated by Alnylam, one
member shall be nominated by Medtronic
and the third shall be selected by the two
members nominated by the Parties. If
the Parties pursue more than one Product
Development Program, the Parties may
elect to [**] for different Product
Development Programs in order to [**] of the
respective Product Development Programs.
The determination of [**] as to such
dispute shall be binding on both Parties.
Each Party shall be responsible for
[**] nominated by it and the Parties shall
share equally in [**]l. The Parties
may also elect by mutual agreement to use
[**] for guidance on other issues that
may arise in the course of the
Collaboration Program.
(d) Collaboration Program Responsibilities. Each Party agrees to
use
its Commercially Reasonable Efforts in good
faith to (i) undertake the
responsibilities assigned to such Party in
the Workplan, (ii) perform its
obligations hereunder in a scientifically
sound and workmanlike manner; (iii) as
appropriate, make available to the other
Party those resources set forth in the
Workplan; and (iv) carry out all work done
in the course of the Collaboration
Program in material compliance with all
applicable federal, state or local laws,
regulations and guidelines governing the
conduct of such work. Either Party may
perform its Collaboration Program
responsibilities hereunder through its
Affiliates or through the use of Third
Party contractors such as contract
research organizations, contract employees,
consultants and the like who merely
conduct activities on behalf of such Party,
are subject to such Party's
supervision and control and will not have
any rights (other than non-exclusive
research rights) in any intellectual
property created in connection such
activities; provided that such Party shall
remain primarily liable for its
obligations under this Agreement.
(e) Discontinuation of Certain Technology Development Program
and
Product Development Program Activities by
Alnylam. Notwithstanding anything to
the contrary in this Agreement, Alnylam
may, in its sole discretion, by written
notice to Medtronic (an "Alnylam
Discontinuation Notice"), discontinue (i) its
Technology Development Program activities
with respect to any Alnylam siRNA or
indication or (ii) its Product Development
Program activities, if in Alnylam's
business judgment the continuation of such
activities is not reasonably likely
to result in the completion of Alnylam's
Technology Development Program or
Product Development Program activities at
an acceptable cost (in view of
Alnylam's expected return from any
resulting Licensed Products), and no such
discontinuation shall constitute a breach
of Alnylam's obligations hereunder.
Any such discontinuation shall constitute a
termination of the Technology
Development Program or Product Development
Program, as applicable; provided that
[**]. Such a termination of a Product
Development Program by Alnylam shall
constitute (A) a [**] with respect to an
Alnylam siRNA included in such Product
Development Program, (B) a [**] with
respect to an Alnylam siRNA included in
such Product Development Program, (C) a
[**] with respect to an Alnylam siRNA
included in such Product Development
Program, or (D) a [**] with respect to an
Alnylam siRNA included in such Product
Development Program. Subject to any other
provision of this Agreement under which
[**], termination of a Product
Development Program pursuant to this
Section 2.3(e) shall not result in [**]
with respect to any Alnylam siRNA(s)
included in such Product Development
Program or in [**] provided that [**].
(f) Discontinuation of Certain Technology Development Program
and
Product Development Program Activities by
Medtronic. Notwithstanding anything to
the contrary in this Agreement, Medtronic
may, in its sole discretion, by
written notice to Alnylam at
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any time (a "Medtronic Discontinuation
Notice"), discontinue (i) its Technology
Development Program activities with respect
to any Alnylam siRNA or indication,
or (ii) its Product Development Program
activities for an Alnylam siRNA included
in such Product Development Program, if in
Medtronic's business judgment the
continuation of such activities is not
reasonably likely to result in the
completion of the Technology Development
Program or Product Development Program
activities at an acceptable cost (in view
of Medtronic's expected return from
any resulting Licensed Products), and no
such discontinuation shall constitute a
breach of Medtronic's obligations
hereunder. Any such discontinuation shall
constitute a termination of the Technology
Development Program or Product
Development Program and Medtronic's
licenses hereunder with respect to all
Alnylam siRNAs included in such Technology
Development Program or Product
Development Program, as applicable.
(g) Failure to Advance Alnylam siRNAs After [**].
Notwithstanding
any other provision of this Agreement, if
an Alnylam siRNA included in a Product
Development Program (i) has achieved
[**]but[**]with respect to such Alnylam
siRNA or any other Alnylam siRNA included
in the same Product Development
Program prior to [**] on which such Alnylam
siRNA [**], or (ii) has achieved
[**] but [**] with respect to such Alnylam
siRNA or any other Alnylam siRNA
included in the same Product Development
Program prior to [**] on which such
Alnylam siRNA achieved [**] (provided
however, that if prior to such [**]
anniversary [**] has been completed but
Medtronic becomes aware or determines,
as a result of [**], that an [**], such
[**] deadline shall automatically be
extended to the [**]), then, in either such
event, Alnylam may, at its option,
notify Medtronic that it intends to
terminate such Product Development Program
and Medtronic's licenses hereunder with
respect to all Alnylam siRNAs included
in such Product Development Program, which
termination (together with any
related consequences of such termination
set forth in Article VIII) shall be
Alnylam's sole and exclusive remedy and
Medtronic's sole and exclusive liability
for such failure to advance. Such
terminations will take effect on [**] unless
(A) if the basis for such notice is [**]
with respect to an Alnylam siRNA
included in such Product Development
Program is commenced prior to the [**], (B)
if the basis for such notice is [**] with
respect to an Alnylam siRNA included
in such Product Development Program has
been [**] prior to the [**] or (C) if
the basis for such notice is [**], prior to
the [**] Medtronic provides to
Alnylam a [**], as applicable, which [**]
is reasonably acceptable to Alnylam,
and thereafter Medtronic [**] in accordance
with such [**].
Section
2.4 Decisionmaking. All decisions of the JRDC shall be made by
unanimous vote of the JRDC Representatives,
with each Party's JRDC
Representatives collectively having one
vote, and the goal of all decision
making shall be to achieve consensus. Upon
fifteen (15) days prior written
notice, either Party may convene a special
meeting of the JRDC for the purpose
of resolving any failure to reach agreement
on a matter within the scope of the
authority and responsibility of the JRDC.
If the JRDC is unable to reach
agreement on any matter so referred to it
for resolution by one or more of the
Parties within thirty (30) days after the
matter is so referred to it, such
matter shall be referred to the Executive
Officers for resolution. If the matter
is not resolved by the Executive Officers
within thirty (30) days after referral
to the Executive Officers, then:
(a) if such matter relates primarily to Collaboration Program
activities with respect to any Alnylam
siRNA or Development Candidate that has
not yet achieved [**], Alnylam shall have
the right to decide the matter;
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(b) if such matter relates primarily to Collaboration Program
activities with respect to any Alnylam
siRNA or Development Candidate that has
achieved [**], Medtronic shall have the
right to decide the matter;
(c) notwithstanding Section 2.4(a) above, i