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Title: |
Research Collaboration and License Agreement |
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Entities: |
Alnylam Pharmaceuticals, Inc.; Hybridon, Inc.; ISIS Pharmaceuticals, Inc.; Medtronic, Inc.; Merck & Co., Inc.; Novartis Pharma AG; Sigma-Aldrich Corp.; Dewey Ballantine LLP; Wilmer, Cutler & Pickering |
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Date: |
2005 |
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Preview shows 42KB of 279KB total |
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Price: |
$96 |
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ID: |
#1058144 |
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RESEARCH COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN
NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH, INC.
AND
ALNYLAM PHARMACEUTICALS, INC.
================================================================================
<PAGE>
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This RESEARCH COLLABORATION AND LICENSE AGREEMENT (this "Agreement"),
effective as of October 12, 2005 (the "Effective Date"), by and between Novartis
Institutes for BioMedical Research, Inc., a corporation organized and existing
under the laws of Delaware, with its principal place of business at 250
Massachusetts Avenue, Cambridge, Massachusetts 02139 ("Novartis"), and Alnylam
Pharmaceuticals, Inc., a corporation organized and existing under the laws of
Delaware, with its principal place of business at 300 Third Street, 3rd Floor,
Cambridge, Massachusetts 02142 ("Alnylam").
RECITALS:
WHEREAS, Novartis is engaged in the business of Discovering,
Developing, Commercializing and Manufacturing products in the Field (each as
defined below);
WHEREAS, Alnylam has developed, acquired and licensed technology
useful for the Discovery, Development, Manufacture, characterization and use of
therapeutic products that function through the mechanism of RNA interference
("RNAi"); and
WHEREAS, Novartis and Alnylam desire to enter into a research
collaboration, upon the terms and conditions set forth in this Agreement, to
identify and optimize RNAi Compounds directed against Selected Targets (each as
defined below).
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 Novartis agree as follows:
ARTICLE I
DEFINITIONS
For the purpose of this Agreement, the following terms, whether used
in singular or plural form, shall have the respective meanings set forth below:
"A List" shall have the meaning set forth in Section 2.1(a).
"Abandoned Program" shall have the meaning set forth in Section
2.3(b).
"Accounting Standards" shall mean, with respect to Alnylam, United
States Generally Accepted Accounting Principles, and with respect to Novartis,
International Financial Reporting Standards.
"Active Program" shall have the meaning set forth in Section 2.3(a).
<PAGE>
"Adoption Consideration" shall have the meaning set forth in Section
4.2(a).
"Adoption Date" shall have the meaning set forth in Section 3.1(c).
"Adoption Fee" shall have the meaning set forth in Section 4.2(a).
"Adoption License" shall have the meaning set forth in Section 3.1(c).
"Adopted Product" shall mean any product that contains one or more
RNAi Compound(s) that are Discovered, Developed, Commercialized or Manufactured
pursuant to the Adoption License.
"Adopted Product Obligations" shall have the meaning set forth in
Section 4.2(a).
"Advisory Group" shall have the meaning set forth in Section 2.5.
"Affiliate" shall mean any Person who directly or indirectly controls
or is controlled by or is under common control with a Party to this Agreement.
For purposes of this definition, "control" or "controlled" shall mean ownership
directly or through one or more Affiliates, of fifty percent (50%) or more of
the shares of stock entitled to vote for the election of directors, in the case
of a corporation, or fifty percent (50%) or more of the equity interest in the
case of any other type of legal entity, status as a general partner in any
partnership, or any other arrangement whereby a Party controls or has the right
to control the Board of Directors or equivalent governing body of a corporation
or other entity, or the ability to cause the direction of the management or
policies of a corporation or other entity. The Parties acknowledge that in the
case of certain entities organized under the laws of certain countries outside
of the US, the maximum percentage ownership permitted by law for a foreign
investor may 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. Without expanding the definition of "control", in the case of Novartis,
"Affiliate" shall also include for purposes hereof Novartis Institute for
Functional Genomics, Inc., the Friedrich Miescher Institute for BioMedical
Research, and Novartis Institute for Tropical Diseases Pte. Ltd.
"Agreement" shall have the meaning set forth in the Preamble, and
shall include, for the avoidance of doubt, all Exhibits and Schedules attached
hereto.
"Alnylam" shall have the meaning set forth in the Preamble.
"Alnylam Intellectual Property" shall mean Alnylam Know-How and
Alnylam Patent Rights.
"Alnylam Know-How" shall mean Know-How now or in the future Controlled
by Alnylam, including Broad RNAi Know-How.
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<PAGE>
"Alnylam Opportunity Notice" shall have the meaning set forth in
Section 2.6(b).
"Alnylam Opportunity Response" shall have the meaning set forth in
Section 2.6(c)(i).
"Alnylam Opportunity Response Period" shall have the meaning set forth
in Section 2.6(c)(i).
"Alnylam Patent Rights" shall mean Patent Rights now or in the future
Controlled by Alnylam, including the Broad RNAi Patent Rights.
"Alnylam Program" shall have the meaning set forth in Section 2.6(b).
"Alnylam Program Agreement" shall have the meaning set forth in
Section 2.6(c)(i)(B).
"Alnylam Property" shall have the meaning set forth in Section 7.2(a).
"Alnylam Sole Inventions" shall have the meaning set forth in Section
6.1(a).
"Annual Net Sales" shall mean, with respect to a Licensed Product, the
Net Sales of such Licensed Product during a Contract Year.
"Audit Rights Holder" shall have the meaning set forth in Section
4.9(a).
"Audit Team" shall have the meaning set forth in Section 4.9(b).
"Auditee" shall have the meaning set forth in Section 4.9(a).
"B List" shall have the meaning set forth in Section 2.1(a).
"Bankrupt Party" shall have the meaning set forth in Section 8.3.
"Bankruptcy Code" shall have the meaning set forth in Section 8.3.
"Base Royalty Amount" shall have the meaning set forth in Section
4.4(e)(ii)(B).
"Blocked Target" shall mean any Target that either (a) is the subject
of a Dedicated Alnylam Program as of the date that Alnylam receives the Target
List or Supplemental Target List naming such Target, or (b) is subject to a
contractual obligation under the terms as of the Effective Date of a
Pre-Existing Alliance Agreement that would be breached by the inclusion of such
Target as a Selected Target or Supplemental Target under this Agreement.
"Blocked Target List" shall have the meaning set forth in Section
2.1(a).
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"Blocking RNAi Intellectual Property" shall have the meaning set forth
in Section 4.5.
"Broad RNAi Intellectual Property" shall mean Broad RNAi Know-How and
Broad RNAi Patent Rights.
"Broad RNAi Know-How" shall mean all Know-How now or in the future
Controlled by Alnylam, that relates to RNAi technology, products or processes,
including, (a) the general structure, architecture, or design of nucleic acid
based molecules which engage RNAi mechanisms in a cell; (b) chemical
modifications of nucleic acids (including any modification to the base, sugar or
internucleoside linkage, nucleotide mimetics, and any end modifications) which
do not abolish the RNAi activity of the nucleic acid molecules in (a); (c)
manufacturing techniques for the nucleic acid based molecules or chemical
modifications of (a) and (b); and (d) all uses or applications of nucleic acid
based molecules or chemical modifications in (a) or (b); but excluding Know-How
which relates solely to (i) a specific Target or small group of Targets; or (ii)
delivery technologies which may be broadly employed for delivery of nucleic acid
based molecules.
"Broad RNAi Patent Rights" shall mean the Patent Rights listed on
Schedule 1(b), the Patents licensed to Alnylam under the Listed Alnylam Third
Party Agreements, and all other Patents now or in the future Controlled by
Alnylam that Cover RNAi technology, products or processes, including, Patents
that Cover (a) the general structure, architecture, or design of nucleic acid
based molecules which engage RNAi mechanisms in a cell; (b) chemical
modifications of nucleic acids (including any modification to the base, sugar or
internucleoside linkage, nucleotide mimetics, and any end modifications) which
do not abolish the RNAi activity of the nucleic acid molecules in (a); (c)
manufacturing techniques for the nucleic acid based molecules or chemical
modifications of (a) and (b); and (d) all uses or applications of nucleic acid
based molecules or chemical modifications in (a) or (b); but excluding Patents
which relates solely to (i) a specific Target or small group of Targets; or (ii)
delivery technologies which may be broadly employed for delivery of nucleic acid
based molecules.
"Business Day" shall mean a day on which banking institutions in
Boston, Massachusetts are open for business.
"Change of Control" shall have the meaning set forth in Section
2.4(b).
"Co-Fund" or "Co-Funding" shall have the meaning set forth in Section
4.6(b).
"Co-Fund Negotiation Period" shall have the meaning set forth in
Section 4.6(c).
"Collaboration Product" shall mean any product that contains one or
more Discovered RNAi Compound(s) as active ingredient(s).
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<PAGE>
"Collaboration Success Milestone" shall mean a decision by Novartis,
at its sole discretion, during the Research Term that the overall progress of
the Research Collaboration is such that Novartis wishes to significantly expand
the scope of its activities in the Field beyond those directed to Selected
Targets.
"Commercialization" or "Commercialize" shall mean any and all
activities directed to marketing, promoting, detailing, distributing, importing,
having imported, exporting, having exported, selling or offering to sell a
product, whether before or after Regulatory Approval for such product has been
obtained.
"Commercially Reasonable Efforts" shall mean, with respect to the
efforts to be expended by a Party with respect to any objective, reasonable,
diligent, good faith efforts to accomplish such objective as such Party would
normally use to accomplish a similar objective under similar circumstances, it
being understood and agreed that with respect to the Discovery, Development or
Commercialization of any Collaboration Product, such efforts shall be
substantially equivalent to those efforts and resources commonly used by such
Party for a product owned by it or to which it has rights, which product is at a
similar stage in its development or product life and is of similar market
potential taking into account efficacy, safety, approved labeling, the
competitiveness of alternative products in the marketplace, the patent and other
proprietary position of the product, the likelihood of regulatory approval given
the regulatory structure involved, the profitability of the product, alternative
products and other relevant factors. Commercially Reasonable Efforts shall be
determined on a market-by-market and product-by-product basis, and it is
anticipated that the level of effort will change over time, reflecting changes
in the status of the Collaboration Product and the market(s) involved.
"Confidential Information" shall mean the terms of this Agreement
(including the list of Selected Targets and the Targets included on any Target
List) and all Know-How or other information, including proprietary information
and materials (whether or not patentable) regarding a Party's technology,
products, business information or objectives, that is treated as confidential by
the disclosing Party in the regular course of business or is otherwise
designated as confidential by the disclosing Party.
"Contract Quarter" shall mean a calendar quarter ending on March 31st,
June 30th, September 30th and December 31st.
"Contract Year" shall mean each calendar year ending on December 31.
"Control" or "Controlled" shall mean, with respect to any intellectual
property right or other intangible property, the possession by a Party (whether
by ownership, license or "control" (as defined in the definition of "Affiliate"
above) over an Affiliate having possession by ownership or license) of the
ability to grant access to, or a license or sublicense of, such rights or
property.
"Controlled Contractor" shall mean either (a) a Third Party contractor
such as a contract research organization, contract employee, consultant and the
like who
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<PAGE>
merely conducts activities on behalf of a Party, is subject to Party's
supervision and control, and will not have any rights (other than non-exclusive
research rights) in any intellectual property created in connection with such
activities, or (b) a Third Party contract manufacturer.
"Cover", "Covered" or "Covering" shall mean, with respect to a Patent
Right, that, in the absence of a license granted to a Person under a Valid Claim
included in such Patent Right, the practice by such Person of an invention
claimed in such Patent Right would infringe such Valid Claim (or, in the case of
a Patent Right that is a Patent Application, would infringe a Valid Claim in
such Patent Application if it were to issue as a Patent).
"CRT Sublicense Agreement" shall have the meaning set forth in Section
3.1(f)(ii).
"Dedicated Alnylam Program" shall mean a bona fide Alnylam Discovery,
Development or Commercialization program directed towards a Target (a) that is
conducted pursuant to a written research, Development or Commercialization plan,
and (b) to which Alnylam has dedicated at least [**] immediately preceding
Alnylam's receipt of the Target List or Supplemental Target List naming such
Target.
"Dedicated Novartis Program" shall mean a bona fide Novartis
Discovery, Development or Commercialization program directed towards a Target
(a) that is conducted pursuant to a written research, Development or
Commercialization plan, and (b) to which Novartis has dedicated at least [**]
immediately preceding Novartis's receipt of the Target Inquiry naming such
Target.
"Develop" or "Development" shall mean any and all preclinical and
clinical drug development activities, including test method development and
stability testing, toxicology, animal efficacy studies, formulation, quality
assurance/quality control development, statistical analysis, clinical studies,
clinical trials and testing, regulatory affairs, product approval and
registration, chemical development and development Manufacturing, packaging
development and Manufacturing and development documentation efforts in support
of development activities anywhere in the world.
"Discover" or "Discovery" shall mean any and all research or discovery
activities.
"Discovered RNAi Compound" shall mean an RNAi Compound directed to a
Selected Target that is Discovered during the course of an Active Program
(excluding Abandoned Programs that do not become Active Programs pursuant to
Sections 2.3(b) or 2.6(c)) together with all derivatives of such RNAi Compound.
For purposes of this definition, "derivative" shall mean a compound that may
contain modified nucleotides or may have been modified by chemical or molecular
genetic means but which still, at least in vitro, functions through an RNAi
mechanism against the same Target.
"Effective Date" shall have the meaning set forth in the Preamble.
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<PAGE>
"Encumbered Field" shall mean:
(a) Until [**], the treatment, prophylaxis and diagnosis of ocular
microvascular disease in humans with RNAi Products, where "ocular microvascular
disease" means age-related macular degeneration and [**], including [**],
including [**]; but specifically excluding [**], such as (by way of example
only) [**].
(b) Until [**], or potentially sooner under certain circumstances:
(i) The treatment of any neurodegenerative disease, but excluding
[**], where "neurodegenerative disease" means 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,
including Parkinson's disease, Huntington's disease, Alzheimer's disease,
and amyotrophic lateral sclerosis, but excluding [**], using
(ii) [**], where "direct delivery to the human nervous system"
does not encompass [**].
(c) After any joint decision by Alnylam and a Pre-Existing Alliance
Party to develop a human therapeutic product that includes siRNA(s) as active
pharmaceutical ingredient(s) to be delivered or approved for delivery via an
implanted infusion device directly to the human nervous system:
(i) Until [**] years after the date of such decision, or
potentially sooner under certain circumstances, [**]; and
(ii) For so long as such therapeutic product is under development
and until its commercial launch, [**]; and
(iii) Following [**] until [**] such product delivered or
approved for delivery via an implanted infusion device to the human nervous
system.
"Event of Bankruptcy" shall have the meaning set forth in Section 8.3.
"Excess Amount" shall have the meaning set forth in Section
4.4(e)(ii)(B).
"Exclusivity Term" shall mean the term commencing on the Effective
Date and terminating upon the Exclusivity Termination Date. The "Exclusivity
Termination Date" shall mean (a) the date of termination of the Research Term,
if this Agreement is terminated pursuant to Section 8.1(a)(ii); (b) the second
(2nd) anniversary following the expiration or termination of the Research Term,
if the Selection Term is less than five (5) years in length (except for the case
where this Agreement is terminated pursuant to Section 8.1(a)(ii)); and (c) the
third (3rd) anniversary following the expiration or termination of the Research
Term, if the Selection Term is at least five (5) years in length.
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<PAGE>
"Executive Officers" shall mean Novartis's Chief Executive Officer (or
the officer or employee of Novartis then serving in a substantially equivalent
capacity) or his/her designee of substantially equivalent rank, and Alnylam's
Chief Executive Officer (or the officer or employee of Alnylam then serving in a
substantially equivalent capacity).
"FDA" shall mean the United States Food and Drug Administration or any
successor agency thereto.
"Field" shall mean all human, veterinary or agricultural applications,
including processes and products directed to the treatment, palliation,
diagnosis or prophylaxis of any or all Indications.
"First Animal Study" shall have the meaning set forth in Section
4.4(a).
"First Commercial Sale" shall mean the first sale of a Licensed
Product by Novartis or an Affiliate or sublicensee of Novartis to a Third Party
in a country following Regulatory Approval of such Licensed Product in that
country or, if no such Regulatory Approval or similar marketing approval is
required, the date upon which such Licensed Product is first commercially
launched in such country.
"FTE" shall mean, in case of an Abandoned Program, Active Program,
Dedicated Alnylam Program, Dedicated Novartis Program or Target
identification/validation services, respectively, the equivalent of the work of
one (1) scientist, full time for one (1) year, for or on behalf of a Party,
which equates to a total of [**] per year of scientific work directly related to
such Abandoned Program, Active Program, Dedicated Alnylam Program, Dedicated
Novartis Program or Target identification/validation services, respectively, and
the direct scientific management thereof.
"Gatekeeper" shall have the meaning set forth in Section 3.1(e)(iv).
"IND" shall mean 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, or any
foreign equivalent thereof, and (b) all supplements and amendments that may be
filed with respect to the foregoing.
"Indemnified Party" shall have the meaning set forth in Section
9.1(c)(i).
"Indemnifying Party" shall have the meaning set forth in Section
9.1(c)(i).
"Indication" shall mean any disease or condition, sign or symptom of a
disease or condition, or symptom associated with a disease or syndrome.
"Infrastructure Fee" shall have the meaning set forth in Section
4.3(c).
"Intellectual Property" shall have the meaning set forth in Section
7.2(a).
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<PAGE>
"Invalidity Claim" shall have the meaning set forth in Section 6.4(c).
"IP Contracts" shall have the meaning set forth in Section 7.2(b).
"Joint Intellectual Property" shall have the meaning set forth in
Section 6.1(b).
"Joint Steering Committee" shall have the meaning set forth in Section
2.2(a).
"Know-How" shall mean any information, inventions, trade secrets or
technology, whether or not proprietary or patentable and whether stored or
transmitted in oral, documentary, electronic or other form, Controlled by a
Party that is necessary or useful to (a) the activities contemplated by the
Research Collaboration, (b) the Discovery, Development, Commercialization or
Manufacture of RNAi Compounds or RNAi Products, or (c) the practice of the RNAi
mechanism or technology. Know-How shall include ideas, concepts, formulas,
methods, procedures, designs, compositions, plans, documents, data, discoveries,
developments, techniques, protocols, specifications, works of authorship,
biological materials, and any information relating to research and development
plans, experiments, results, compounds, therapeutic leads, candidates and
products, clinical and preclinical data, clinical trial results, and
Manufacturing information and plans (but excluding any scientific, regulatory,
pre-clinical or clinical information or data regarding specific Indications and
any marketing, financial, commercial, personnel and other business information
and plans); in each case, to the extent necessary or useful to the activities
contemplated by the Research Collaboration or to the Discovery, Development,
Commercialization or Manufacture of the RNAi Compounds or RNAi Products.
"Law" shall mean any law, statute, rule, regulation, ordinance or
other pronouncement having the effect of law of any federal, national,
multinational, state, provincial, county, city or other political subdivision,
domestic or foreign.
"Licensed Products" shall mean: (a) the Collaboration Products, and
(b) the Adopted Products.
"Licensed Property" shall have the meaning set forth in Section
7.2(a).
"Listed Alnylam Third Party Agreement" shall mean an agreement listed
on Schedule 1(l).
"Listed Alnylam Third Party Payments" shall have the meaning set forth
in Section 4.4(e)(ii)(A).
"Listed Counterparties" shall mean the Third Party counterparties to
Listed Alnylam Third Party Agreements and their respective successors in
interest.
"Major Market Country" shall mean, individually and collectively, the
United Kingdom, France, Germany, Italy, Spain and Japan.
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<PAGE>
"Manufacture" or "Manufacturing" shall mean any and all activities and
operations involved in or relating to the manufacturing, quality control testing
(including in-process, release and stability testing), releasing or packaging,
for pre-clinical, clinical or commercial purposes.
"Minimum Quarterly Payment" shall have the meaning set forth in
Section 4.4(e)(iii).
"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, or any foreign equivalent thereof, and
(b) all supplements and amendments that may be filed with respect to the
foregoing.
"Net Sales" shall mean, with respect to a Licensed Product, the gross
amount invoiced by or on behalf of Novartis or any Novartis Affiliate, licensee
or sublicensee for that Licensed Product sold to Third Parties (other than
licensees or sublicensees) in bona fide, arm's-length transactions, less
customary deductions, determined in accordance with Novartis's standard
accounting methods and in accordance with International Financial Reporting
Standards (IFRS) as generally and consistently applied by Novartis, to the
extent included in the gross invoiced sales price of any Licensed Product or
otherwise directly paid or incurred by Novartis, its Affiliates or distributors
with respect to the sale of such Licensed Product, including: (a) free goods;
(b) cash discounts; (c) direct to customer discounts; (d) charge-backs; (e)
Medicaid rebates; (f) deductions due for discount card programs; (g) amounts
repaid or credited by reasons of defects, rejection recalls, returns; (h)
tariffs, duties, excise, sales, value-added and other taxes (other than taxes
based on income); (i) delayed ship order credits; (j) all insurance expense
included in the invoice price; (k) amounts credited for uncollectible amounts on
previously sold products; (l) deduction of [**] for distribution and warehousing
expenses; and (m) any other reduction or specifically identifiable amounts
included in the Licensed Product's gross invoice that are creditable for reasons
substantially equivalent to those listed above. Sales between or among Novartis,
its Affiliates or their respective licensees and sublicensees shall be
disregarded for purposes of calculating Net Sales. Any of the items set forth
above that would otherwise be deducted from the invoice price in the calculation
of Net Sales but which are separately charged to Third Parties shall not be
deducted from the invoice price in the calculation of Net Sales.
i) In the case of any sale or other disposal of a Licensed Product
between or among Novartis and its Affiliates, licensees and sublicensees, for
resale, Net Sales shall be calculated as above only on the value charged or
invoiced on the first arm's-length sale thereafter to a Third Party;
ii) In the case of any sale which is not invoiced or is delivered
before invoice, Net Sales shall be calculated at the time of shipment or when
the Licensed Product is paid for, if paid for before shipment or invoice;
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iii) In the case of any sale or other disposal for value, such as
barter or counter-trade, of any Licensed Product, or part thereof, other than in
an arm's-length transaction exclusively for money, Net Sales shall be calculated
as above on the value of the non-cash consideration received or the fair market
price (if higher) of the Licensed Product in the country of sale or disposal;
iv) In the event the Licensed Product is sold in a finished dosage
form in combination with one or more other active ingredients (a "Combination
Product"), the Net Sales of the Licensed Product, for the purposes of
determining royalty payments, shall be determined by multiplying the Net Sales
(as defined above) of the Combination Product by the fraction, 'A/(A+B)' where
'A' is the weighted (by sales volume) average sale price in the relevant country
of the Licensed Product when sold separately in finished form and 'B' is the
weighted average sale price in that country of the other product(s) sold
separately in finished form. In the event that such average sale price cannot be
determined for both the Licensed Product and the other product(s) in the
Combination Product, Net Sales for purposes of determining royalty payments
shall be agreed by the Parties based on the relative value contributed by each
component, such agreement shall not be unreasonably withheld.
"Non-Bankrupt Party" shall have the meaning set forth in Section 8.3.
"Novartis" shall have the meaning set forth in the Preamble.
"Novartis Intellectual Property" shall mean all Patent Rights and
Know-How now or in the future Controlled by Novartis that are necessary or
useful for the conduct of the activities contemplated by the Research
Collaboration and all Patent Rights that Cover the foregoing Know-How.
"Novartis Overpayment" shall have the meaning set forth in Section
4.4(e)(ii)(B).
"Novartis Sole Inventions" shall have the meaning set forth in Section
6.1(a).
"Owned Know-How" shall have the meaning set forth in Section 7.2(a).
"Owned Patents" shall have the meaning set forth in Section 7.2(a).
"Owned Property" shall have the meaning set forth in Section 7.2(a).
"Party" shall mean Alnylam or Novartis; "Parties" shall mean Alnylam
and Novartis.
"Patent Offices" shall have the meaning set forth in Section 7.2(f).
"Patent Rights" shall mean utility and design patents and all
substitutions, divisions, continuations, continuations-in-part, reissues,
reexaminations and extensions thereof and supplemental protection certificates
relating thereto, and all counterparts
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thereof or substantial equivalents in any country, including utility models and
industrial designs (collectively, "Patents") and any applications or provisional
applications for any of the foregoing ("Patent Applications").
"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.
"Phase I Study" shall mean a study of a 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) in the protocol relating to efficacy.
"Phase II Study" shall mean (a) a dose exploration, dose response,
duration of effect, kinetics, dynamic relationship or preliminary efficacy and
safety study of a product in the target patient population, or (b) a controlled
dose ranging clinical trial to evaluate further the efficacy and safety of a
product in the target patient population and to define the optimal dosing
regimen.
"Phase III Study" shall mean a controlled pivotal clinical study of a
product that is prospectively designed to demonstrate statistically whether such
product is effective and safe for use in a particular Indication in a manner
sufficient to obtain Regulatory Approval to market such product.
"Post-IND Alnylam Program" shall have the meaning set forth in Section
2.6(c)(i)(B).
"Pre-Existing Alliance Agreements" shall mean the agreements set forth
on Schedule 1(p).
"Pre-Existing Alliance Parties" shall have the meaning set forth in
Section 3.1(e)(i).
"Pre-IND Alnylam Program" shall have the meaning set forth in Section
2.6(c)(i)(A).
"Pre-Paid Adopted Product Fees" shall have the meaning set forth in
Section 4.2(a).
"Product Liability Claim" shall have the meaning set forth in Section
9.1(a).
"Program Data" shall have the meaning set forth in Section 6.1(d).
"Redacted Research Collaboration and License Agreement" shall have the
meaning set forth in Section 5.1.
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"Registration Filing" shall mean an application submitted to a
Regulatory Authority to initiate human clinical trials or for marketing approval
of a product, including an IND, NDA, a Biologics License Application, any
equivalent of the foregoing in any jurisdiction, and all supplements and
amendments that may be filed with respect to the foregoing.
"Regulatory Approval" shall mean, with respect to a product in a
country, the approval of the applicable Regulatory Authority necessary for the
marketing and sale of such product in such country.
"Regulatory Authority" shall mean any federal, national,
multinational, state, provincial or local regulatory agency, department, bureau
or other governmental entity with authority over the marketing, pricing or sale
of a pharmaceutical product in a country, including the FDA.
"Research Collaboration" shall mean the activities of the Parties
under Research Plans to identify and optimize RNAi Compounds directed against
Selected Targets and develop improved RNAi technology to enable and enhance the
utility of such RNAi Compounds, upon and subject to the terms and conditions set
forth in this Agreement.
"Research Institution" shall mean an academic, non-profit research
institution or hospital that conducts Discovery or Development activities on
behalf of or in collaboration with Alnylam and to which Alnylam does not grant
any Commercialization rights under Alnylam Intellectual Property with respect to
any RNAi Compounds or RNAi Products provided by Alnylam or Discovered or
Developed in the course of such Discovery or Development activities.
"Research Plan" shall have the meaning set forth in Section 2.3(a).
"Research Term" shall have the meaning set forth in Section
8.1(a)(iii).
"RNAi" shall have the meaning set forth in the Recitals.
"RNAi Compound" shall mean any compound that in vitro or otherwise
functions through the mechanism of RNAi and consists of or encodes
double-stranded RNA, and which double-stranded RNA is optionally chemically
modified to contain modified nucleotide bases or non-RNA nucleotides, and
optionally may be administered in conjunction with a delivery vehicle or vector.
"RNAi Product" shall mean any product that contains one or more RNAi
Compounds as an active ingredient.
"RNAi Therapeutic Rights" shall mean the right to Discover, Develop,
Commercialize or Manufacture RNAi Compounds and RNAi Products for therapeutic
uses.
13
<PAGE>
"Royalty Term" shall mean, separately with respect to each Licensed
Product in each country, the period commencing on the First Commercial Sale of
such Licensed Product in such country and concluding on the later of (a) the
expiration of the last to expire Alnylam Patents containing a Valid Claim
Covering the Development, Commercialization or Manufacture of such Licensed
Product in that country, or (b) [**] after the date of First Commercial Sale of
such Licensed Product in that country.
"Selected Target" shall have the meaning set forth in Section 2.1(a).
"Selected Target Threshold" shall have the meaning set forth in
Section 2.1(a).
"Selection Term" shall have the meaning set forth in Section
8.1(a)(i).
"Severed Clause" shall have the meaning set forth in Section 9.4.
"Significant Pharmaceutical Company" shall have the meaning set forth
in Section 2.4(b).
"Sole Inventions" shall have the meaning set forth in Section 6.1(a).
"sPOC" shall mean the selection by Novartis, in its sole discretion,
of a Discovered RNAi Compound for the clinical phase of Development by Novartis.
The specific criteria used to determine sPOC on a Discovered RNAi
Compound-by-Discovered RNAi Compound basis shall be set forth in the applicable
Research Plan.
"Stacking Reduction" shall have the meaning set forth in Section
4.4(e)(iii).
"Stock Purchase Agreement" shall mean that certain Stock Purchase
Agreement, dated as of September 6, 2005, between Alnylam and Novartis Pharma
AG, together with that certain Investor Rights Agreement, between Alnylam and
Novartis Pharma AG, dated as of September 6, 2005.
"Successful Completion" shall mean the execution of a study approved
by the Joint Steering Committee in material compliance with all criteria set
forth by the Joint Steering Committee (but without regard to results).
"Supplemental Target" shall have the meaning set forth in Section
2.1(b)(ii).
"Supplemental Target List" shall have the meaning set forth in Section
2.1(b)(ii).
"Supplemental Target Response Notice" shall have the meaning set forth
in Section 2.1(b)(ii).
14
<PAGE>
"Supplemental Target Threshold" shall have the meaning set forth in
Section 2.1(b)(ii).
"Target" shall mean: (a) a polypeptide or entity comprising a
combination of at least one polypeptide and other macromolecules, that is a site
or potential site of therapeutic intervention by a therapeutic agent; or a
nucleic acid which is required for expression of such polypeptide; (b) variants
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