EXHIBIT 10.4
FOIA CONFIDENTIAL TREATMENT
REQUESTED
STRATEGIC ALLIANCE
AGREEMENT
Between
S IRNA T HERAPEUTICS , I NC .
And
A LLERGAN
Effective
September 28,
2005
S TRATEGIC A LLIANCE A GREEMENT
T HIS A GREEMENT is entered into on September 28, 2005 (the
“Effective Date”) between
A LLERGAN , I NC ., a
Delaware Corporation having its principal place of business at 2525
Dupont Drive, Irvine, California 92612, A
LLERGAN S ALES , LLC , a Delaware Limited Liability Company, having a
place of business at 2525 Dupont Drive, Irvine, California 92612,
United States , and A LLERGAN P HARMACEUTICALS H OLDINGS (I RELAND ) L TD . , an
Irish company, having a registered address at Longphort House,
Earlsfort Centre, Lower Leeson Street, Dublin 2, Ireland
(collectively, “Allergan”) and
S IRNA T HERAPEUTICS , I NC ., a
Delaware Corporation, having a place of business at 185 Berry
Street, Suite 6504, San Francisco, CA 94107 (“Sirna”)
(collectively, the “Parties”).
The Parties agree as follows.
1. D EFINITIONS
1.1 “Affiliate” means any entity
that controls, is controlled by, or is under common control with a
Party. An entity “controls” another if it owns more
than fifty percent (50%) of the outstanding voting securities
of a corporation or has a comparable equity interest in any other
type of entity.
1.2 “Allergan Drug Delivery
System ” or “
Allergan DDS ” means a Delivery System Controlled by
Allergan.
1.3 “Allergan Named
Target” means a
Target designated by Allergan under this Agreement in accordance
with Section 3.7 hereof.
1.4 “Alliance Manager”
has the meaning set forth in
Section 2.2(d).
1.5 “Backup Compound”
means a Lead Compound that the JSC
has selected pursuant to Section 3.10 as a backup candidate
for clinical development.
1.6 “Compound”
means a composition comprising
[***]* as active ingredients, known as of the Effective Date or
discovered pursuant to this Agreement subsequent to that date,
against the Allergan Named Targets in the Field.
1.7 “Confidential
Information” means
all information disclosed by one Party to another and as further
set forth in Section 10 hereof.
1.8 “Controlled”
means, with respect to any material,
data, information, or intellectual property right, that a Party
owns, co-owns, or has a license to such material, data,
information, or intellectual property right and has the ability to
grant access, a license, or a sublicense to such
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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material, data, information, or intellectual
property right to the other Party under this Agreement and its
Affiliates and sublicensees for use or application in the Field
without violating an agreement with, or infringing any rights of, a
third party.
1.9 “Cost of Goods” or
“COGS” means
fully-burdened standard costs of supplying Compounds calculated in
accordance with Sirna’s accounting methods consistently
applied, which methodology will be calculated in compliance with
U.S. generally accepted accounting principles (GAAP). Costs include
raw materials, API, components, labor and overhead attributed to
the production, processing, quality control, labeling and packaging
of the product for the manufacture of bulk drug and Compounds.
[***]*
1.10 A
patent “Covers” a composition or method if the
patent has not expired and if the composition or method would
infringe, but for this Agreement, at least one claim of the patent
and a court or other authority of competent jurisdiction has not
held the claim to be invalid or unenforceable. An application
“Covers” a composition or method if the
composition or method would infringe a claim of the application
were a patent to issue that recites the claim.
1.11 “Data” means any and all data and results generated by
the Parties independently or jointly under this
Agreement.
1.12 “Delivery Systems”
or “DDSs” means a
substrate, encapsulant, mechanical device, ocular implant or other
means for delivering Licensed Product to a patient in need of
treatment, which Delivery System, in the absence of a Drug would
have no therapeutic utility.
1.13 “Development
Compound” means a
Pre-Development Compound that the JSC has designated pursuant to
Section 3.12 for clinical development.
1.14 “Development Plan”
means a plan prepared by Allergan in
collaboration with Sirna for the development of Development
Compounds, [***]*, as amended or modified from time to time by the
JSC.
1.15 “Development Team”
has the meaning set forth in
Section 2.2(c).
1.16 “Development Team
Leader” has the
meaning set forth in Section 2.2(c).
1.17 “Drug” means a composition intended for use in the
cure, mitigation, treatment, or prevention of disease.
1.18 “FDA” means the U.S. Food and Drug Administration, or
any Regulatory Authority that is the successor thereto.
1.19 “Field” means conditions and diseases affecting the
[***]* and treatments for such conditions and diseases. Such
conditions and diseases include, for example, [***]*.
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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1.20 “First Commercial
Sale” means in any
country, the first sale for use by the general public of a Licensed
Product after required marketing and pricing approvals have been
granted by the Regulatory Authority of that country.
1.21 “FTE” means one full time-equivalent research and/or
development employee, with qualifications in the relevant field,
defined as [***]* scientific hours of effort per year. The FTE rate
will be [***]* to be adjusted upward at a rate of [***]* per year
every year on the anniversary of the Effective Date.
1.22 “Lead” is a Compound identified against each Allergan
Named Target by Sirna pursuant to Section 3.9.
1.23 “Lead Compound”
is a Lead selected by JSC pursuant
to Section 3.10 for evaluation in the Field.
1.24 “Licensed Product”
means a Development Compound for
which the Parties obtain the approval from any Regulatory Authority
to sell for use by the general public in the Field.
1.25 “JSC” means the “Joint Steering Committee”
described in Section 2
1.26 [***]*
1.27 “Net Sales”
means, with respect to a given
period of time, gross sales in such period, less the following
deductions from such gross amounts which are actually incurred,
allowed or paid, and specifically relate to Licensed
Products:
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a)
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credits or
allowances actually granted for damaged products, returns or
rejections of product, price adjustments and billing
errors;
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b)
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governmental
and other rebates (or equivalents thereof) granted to managed
health care organizations, pharmacy benefit managers (or
equivalents thereof), federal, state/provincial, local and other
governments, their agencies and purchasers and reimbursers or to
trade customers, to the extent allowed and taken;
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c)
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normal and
customary trade, cash and quantity discounts, allowances and
credits to the extent allowed or taken;
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e)
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transportation
costs, including insurance, for outbound freight related to
delivery of the product to the extent included in the gross amount
invoiced and not subject to reimbursement;
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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f)
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sales taxes,
VAT taxes and other taxes directly linked to sales of Licensed
Products to the extent included in the gross amount invoiced, to
the extent payable by Allergan and not subject to reimbursement;
and
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h)
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Sales between
Allergan and its Affiliates will be excluded from the computation
of Net Sales, but the subsequent final sales to third parties by
such Affiliates will be included in the computation of Net Sales.
No other costs, including without limitation the costs incurred in
the manufacturing, selling, advertising and/or distribution of
Licensed Products will be deducted in the computation of Net
Sales.
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i)
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If a Licensed
Product is sold in the form of a combination containing i) a
Licensed Product and ii) a Drug, Net Sales for such a
combination product will be calculated by multiplying actual Net
Sales of the combination product by the fraction A/(A+B), where
“A” is the is the sales price of such Licensed Product
in the combination when sold separately and “B” is the
total sales price of such other biologically active component in
the combination when sold separately. If the Licensed Product and
the other biologically active component are not sold separately,
the percentage of the total cost of the combination product
attributed to cost of the Licensed Product will be multiplied times
the sales price of the combination product to arrive at Net
Sales.
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If a Licensed Product is sold in the form of a
combination containing i) a Licensed Product and ii) a Delivery
System, Net Sales of the Licensed Product with respect to such a
combination product will be equal to Net Sales of the
combination.
1.28 “Patent Cost
Reimbursement” means Patent Costs relating to the Sirna Patents
licensed to Allergan hereunder, with respect to which Allergan will
be obligated to reimburse Sirna as provided in Article
9.
1.29 “Patent Costs”
means the fees and expenses paid to
outside legal counsel and other third parties, and investigation,
filing, prosecution and maintenance expenses incurred by and on
behalf of a Party in connection with the filing, prosecuting, and
maintaining of a patent or application.
1.30 “Pre-Development
Compound” means a
Lead Compound that has been selected by the JSC to advance into
IND-enabling studies.
1.31 “Regulatory
Authority” means an
agency of any government having the authority to regulate the sale,
manufacture, marketing, testing and/or pricing of drugs.
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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1.32 “Research Plan”
is that document attached hereto as
Exhibit A and as amended from time to time by the JSC, as
provided for in this Agreement.
1.33 “Research Team”
has the meaning set forth in Section
2.2(b).
1.34 “Research Team
Leader” has the
meaning set forth in Section 2.2(b).
1.35 “Research Term”
means [***]* from the Effective Date
of this Agreement and as further set forth in Section 3.7
hereof, unless terminated sooner as set forth in the
Agreement.
1.36 “RNAi” or “RNA
interference” means, for the purposes of this Agreement,
[***]*.
1.37 “RNAi Data”
has the meaning set forth in
Section 7.6.
1.38 “Scientifically and Commercially
Reasonable and Diligent Efforts” means those efforts consistent with the exercise
of prudent scientific and business judgment, as applied to other
research, development and commercialization programs or products of
similar scientific and commercial potential within the relevant
product lines of Allergan and its Affiliates, or Sirna and its
Affiliates, as the case may be.
1.39 “siNA” means a synthetic [***]*.
1.40 “Sirna 027”
has the meaning set forth in Exhibit
E.
1.41 The “Sirna 027 Clinical Development
Plan” comprises the documents attached hereto as
Exhibits B, C, and D .
1.42 “Sirna Know-How”
means all scientific information
relating to the use of the Compounds in research and development in
accordance with the Research Plan or the Development Plan,
including the assays used to carry out research relating to the
Compounds, so far as such information is Controlled by Sirna and
Sirna is not prevented by contractual obligation from licensing or
disclosing such information to Allergan.
1.43 “Sirna Patents”
means a) the patents and
applications listed in Exhibit F; b) any application that claims
priority to the foregoing patents and applications; and c) any
patent that issues from any of the applications described in
clauses a) and b) above.
1.44 “Target”
means [***]*.
1.45 “Third Party
Licensee” means a
third party, not an Affiliate, to which a Party licenses its rights
to sell Licensed Products.
1.46 “Tuschl License”
means a certain worldwide license
agreement dated September 8, 2003, entered into by and between
Sirna and the University of Massachusetts Medical School for the
intellectual property (patent application filed by Tuschl et al.,
International PCT Publication No. WO 01/75164) covering short
interfering RNA (siRNA).
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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2. S COPE AND M ANAGEMENT OF C OLLABORATION
2.1 Scope of the Collaboration
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a)
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Scope . Each Party will use Scientifically and
Commercially Reasonable and Diligent Efforts to carry out its
obligations as specified under Section 3.1 of this Agreement
and will keep the JSC informed on the progress of the
collaboration.
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(i)
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Personnel . Sirna will commit such employees and resources
to the collaboration as necessary to fulfill its obligations under
this Agreement.
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(ii)
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Sirna will take
the lead in development of Leads and chemical synthesis of all
Compounds (including Leads, Pre-Development Compounds, Development
Compounds, Back-up Compounds, and Licensed Products). This will
include preparing specific plans, performing the majority of work,
acting as project leader and requesting Allergan support when
needed.
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(iii)
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Sirna will
provide Allergan with the Data and other relevant information
necessary for Allergan to conduct its activities under the
Agreement, subject to any limitations or reservations in other
agreements.
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(iv)
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Sirna will
provide an updated draft Research Plan as necessary (at a minimum
once per year) to the JSC for approval.
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c)
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Allergan
Obligations .
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(i)
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Personnel . Allergan will commit such employees and
resources as necessary to fulfill its obligations under this
Agreement.
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(ii)
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Allergan will
provide Sirna with the Data and other relevant information
necessary for Sirna to conduct its activities under the Agreement,
subject to any limitations or reservations in other
agreements.
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(iii)
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Other than as
set forth herein, Allergan will take the lead in all activities
under this Agreement, e.g., in using a Backup Compound, Lead
Compound, Pre-Development Compound, or Development Compound to
bring a Licensed Product from discovery through development and
into the commercial market, including regulatory submissions and
commercialization strategies. This will also include preparing
plans and budgets, funding all the activities, performing the
majority of work, acting as project leader, and requesting
Sirna’s assistance when needed.
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(iv)
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Allergan will
provide an updated draft Research Plan and Development Plans as
necessary (at a minimum once per year) to the JSC for
approval.
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2.2 Management of the Collaboration
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a)
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Joint
Steering Committee .
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(i)
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Formation
and Membership . The
Parties will establish a joint steering committee (the
“JSC”) no later than thirty (30) days after the
Effective Date. Each Party will have at least one JSC
representative with senior level decision-making authority within
that Party. Each Party will be free to change its representative
members at any time upon written notice to the other Party. The
collaborative effort contemplated hereunder will be conducted under
the overall direction of a Joint Steering Committee or JSC
comprised of six (6) members. Three (3) members will be
appointed by each of Allergan and Sirna.
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(ii)
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Chairperson . The JSC will be chaired by an Allergan
representative during the first year. Sirna may name the chair
during the subsequent year, and the Parties will alternate
thereafter in appointing chairs to a one-year term. The chair will
be responsible for overseeing meetings of the JSC and may have such
other responsibilities as the JSC determines.
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(iii)
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Responsibilities . The JSC will be responsible for directing the
collaboration, including approving, reviewing, monitoring,
providing input and suggesting changes to the Research Plan and
Development Plans. The responsibilities of the JSC include, as
appropriate:
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(1)
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Monitoring all
of the research and development under this Agreement. Any such
research and development must be described in a plan submitted to
the JSC for its consent. The JSC will monitor the progress of such
research and may at any time request reports describing it with as
much specificity as the JSC may determine;
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(2)
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Selection of
Lead Compound(s) from a series of Leads;
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(3)
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Selection of a
Pre-Development Compound(s) for IND-enabling clinical studies from
one or more Lead Compounds;
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(4)
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Selection of a
Development Compound(s) for human clinical development from one or
more Pre-Development Compounds;
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(5)
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Determination
that an Allergan Named Target is no longer suitable for further
research and development under the collaboration;
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(6)
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Review and
approval of achievement of clinical milestones; and
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(7)
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Alerting
management of both Parties when there are significant changes in
the timeframe and/or costs contained in the budget, and when target
dates will not be met, what remedial actions are to be
taken.
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(iv)
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Meetings . The JSC will meet in person a minimum of four
(4) times a year on an approximately quarterly basis at times
mutually convenient to both Parties or as otherwise required for
the purposes of the collaboration. Meetings will alternate between
Sirna’ and Allergan’s facilities, unless otherwise
agreed by the Parties. The JSC may meet more often at such other
times as agreed by the JSC, and such interim discussions may occur
in person or by means of telephone or video conferences. Each Party
will bear the travel, lodging and board expenses associated with
attendance at JSC meetings by its JSC members, Research Team
Leaders, Development Team Leaders, research team members, and
development team members, as appropriate. A reasonable number of
non-voting representatives of either Party with relevant experience
or expertise may also attend JSC meetings as approved by the JSC
chairperson.
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(v)
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Minutes . On an alternating basis between the Parties
(beginning with Allergan), a Party’s Alliance Manager will be
responsible for keeping accurate minutes of the applicable JSC
meeting, including all decisions made and actions taken. Drafts of
the minutes will be delivered to the other Party’s Alliance
Manager within ten (10) business days after the meeting for
distribution to that Party’s other JSC members. Each Party
has the right to request amendments to the minutes within five
(5) business days after receiving them. The Party responsible
for the minutes will revise the minutes in accordance with all
requested amendments and will provide revised minutes to the other
Party within five (5) business days after receipt of any
requested amendments. Minutes are effective when approved by both
Parties.
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(vi)
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Decision
Making. All decisions of
the JSC must be unanimous. If the JSC is unable to reach unanimous
consent on an issue, it will submit the issue to the Executive Vice
President, Research and Development of Allergan, and the Chief
Executive Officer of Sirna, who will confer in good faith to
resolve the dispute; should these executives fail to agree, the
decision of the Allergan executive will become the binding decision
of the JSC, provided, that no such decision may impose on Sirna any
obligation or liability inconsistent with this Agreement, Research
Plan, and/or Development Plan, in effect as of the Effective Date,
without Sirna’s consent.
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(vii)
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Limitation
of Powers . The JSC has
only those powers that are specifically delegated to it herein,
including the powers to amend the plans attached to this Agreement
as Exhibits A-D, but does not have the power to amend this
Agreement.
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(i)
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Research Team
. The Parties will assign
appropriate personnel to carry out their scientific obligations
under this Agreement (collectively known as the
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“Research Team”) in
accordance with the Research Plan. Each Party will assign one
individual to be the Research Team Leader for that
Party.
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(ii)
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Responsibilities . The Research Team shall be responsible, with
oversight and approval by the JSC, for formulating and executing
the specific details of the research in accordance with the
deadlines and deliverables in the Research Plan. The Research Team
will also be responsible for drafting any updates or modifications
to the Research Plan as appropriate and submit it to the JSC for
approval.
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(iii)
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The
representatives of each of the Research Teams may meet as deemed
appropriate and necessary by the respective Research Team Leader to
discuss the activities, under the Research Plan.
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(i)
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Development
Team . The Parties will
assign appropriate personnel to carry out their scientific
obligations under this Agreement (collectively known as the
“Development Team”) in accordance with the Development
Plan. Each Party will assign one individual to be the Development
Team Leader for that Party.
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(ii)
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Responsibilities . The Development Team will be responsible, with
oversight and approval by the JSC, for formulating and executing
the specific details of development in accordance with the
deadlines and deliverables in the Development Plan. The Development
Team will also be responsible for drafting any updates or
modifications to the Development Plan as appropriate and submit it
to the JSC for approval.
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(iii)
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The
representatives of each of the Development Teams may meet as deemed
appropriate and necessary by the respective Development Team Leader
to discuss the activities, under the Development Plan.
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(i)
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Alliance
Management . Each Party
will assign an Alliance Manager who will manage the relationship
between the Parties to achieve the overall goals of the
collaboration. The Alliance Managers, who may be a member of the
JSC, will be invited to attend all the JSC, Research Team and
Development Team meetings.
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(ii)
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Responsibilities
. The Alliance Managers will be
responsible for senior level program and project management
oversight and leadership as well as relationship management of the
collaboration including, but not limited to: developing a set of
operating guidelines for alliance management of the collaboration;
coordinating the development and communication of the Research Plan
and Development Plan; identifying and managing any changes to the
Research Plan and Development Plan; managing the
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collaboration across all
projects; determining roles and responsibilities for team members
on specific projects within the collaboration; overseeing project
timelines and deliverables; tracking and reporting program status,
progress, changes and issues to the JSC; coordinating Research Team
and Development Team meetings, milestone meetings and JSC meetings;
and tracking, analyzing and reporting project results to
demonstrate value and impact on the collaboration.
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3. C ONDUCT OF R ESEARCH AND D EVELOPMENT
3.1 The Parties will conduct the research and
development described in the Research Plan and Development Plan,
including the Sirna-027 Clinical Development Plan, and as set forth
in this Section 3 below. The JSC may at any time amend in writing a
plan, provided, that no such amendment may impose on Sirna any
obligation or liability except as specifically set forth in this
Agreement, Research Plan, and/or Development Plan, in effect as of
the Effective Date, without Sirna’s consent. Allergan and
Sirna will each use Scientifically Reasonable and Diligent Efforts
to research, develop and commercialize Licensed Products in the
Field, in the manner set forth (or to be set forth) in the Research
Plan and/or Development Plan, subject to the provisions of Sections
3.6 and 3.13.
As to Sirna
027
3.2 Sirna will complete [***]* all phase I clinical
trials of Sirna 027, as described in the Sirna-027 Clinical
Development Plan.
3.3 Sirna will manufacture and supply Sirna 027 to
Allergan in the quantities and having the characteristics specified
by the Sirna-027 Clinical Development Plan, for which Allergan will
pay to Sirna [***]*.
3.4 As
of the Effective Date, Sirna 027 will be a Development
Compound.
3.5 Allergan agrees to advance Sirna 027 into Phase
II clinical trials for age-related macular degeneration
(“AMD”) as set forth under the Sirna 027 Clinical
Development Plan within [***]* of the Effective Date, [***]*.
Allergan will be responsible for all costs associated with such
clinical trials, and any additional clinical trials and
commercialization efforts that the JSC decides to undertake. In
support of such trials, Sirna will complete a pre-clinical
toxicology program, [***]*.
3.6 In
the event that [***]*
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a)
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the Parties
will negotiate in good faith regarding the possibility of [***]* on
terms to be mutually agreed upon; and
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b)
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if after [***]* months the
Parties are unable to agree upon the terms of [***]*, then all
rights to Sirna 027 and the associated data and results will
automatically
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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revert to Sirna without any
further obligation to Allergan, and Allergan will cease to have any
rights to Sirna 027.
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[***] *.
As to Other
Compounds
3.7 For a period of [***]* after the Effective Date,
Allergan will have the right to designate up to a total of [***]*
Targets [***]* in Year 1 and [***]* over [***]*, with no more than
[***]* in any one of those years), solely for use in the Field, by
giving notice to the JSC of its selection. The JSC will then notify
Sirna of the identity of the Targets designated by Allergan.
Allergan will be required to name the first [***]* within [***]* of
the Effective Date of this Agreement. Allergan will be required to
name the next [***]* within [***]* from the Effective Date of this
Agreement. For the purposes of this Agreement a [***]* targeting
[***]* will constitute one Target. As to other [***]*, Allergan has
the option of i) counting it as [***]*; or ii) counting it as
[***]* on the condition that the provisions of Section 3.9(f) will
apply.
3.8 Allergan will not have the right to designate
any Targets beyond the [***]* from the Effective Date. For a period
of [***]* after the Effective Date, Allergan may at any time [***]*
Target [***]*, provided that Sirna [***]* against the Allergan
Named Target [***]*.
3.9 For a period of [***]* after the Effective
Date:
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a)
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Sirna will
develop, according to the Research Plan, Leads directed against
each of the Allergan Named Targets designated pursuant to
Section 3.7. Sirna will promptly notify the JSC upon the
identification of Leads against an Allergan Named Target. Sirna
will perform [***]* all in vitro research described in the
Research Plan relating to the identification and evaluation of
Leads, and will provide to Allergan Data and methodologies
sufficient to reproduce such research internally.
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b)
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On the approval
of the JSC [***]*, Sirna will design, manufacture, and supply to
Allergan Lead Compounds, in the quantities and having the
characteristics specified by the Research Plan, for which Allergan
will pay to Sirna [***]*.
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c)
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On the approval
of the JSC [***]*, Sirna will develop analytical methods for Lead
Compounds to support the evaluation of Lead Compounds in the in
vivo test systems, for which Allergan will pay to Sirna [***]*
to compensate Sirna for such work.
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d)
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On the approval
of the JSC [***]*, Sirna will develop process and analytical
development methods to support IND filing and GMP synthesis,
stability studies, and API, for which Allergan will pay to Sirna
[***]* to compensate Sirna for such work.
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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e)
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Sirna will not
be obligated to carry out any [***]* under the Research Plan or
otherwise under this Agreement.
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f)
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Sirna will not
be obligated to carry out activities and identify Leads during any
year against more than the maximum number of Targets that may be
selected pursuant to Section 3.7 with respect to such year. In
the event that Allergan desires Sirna to evaluate more than such
maximum number of Targets per year or perform any other activities
not specifically set forth in this Agreement, Research Plan, and/or
Development Plan, in effect as of the Effective Date, then Sirna at
its sole discretion may choose to carry out such additional
activities [***]* to be funded by Allergan. Any such activities and
the extent of such funding will be based on mutual agreement of the
Parties.
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3.10 At any time after receiving Data from Sirna, the
JSC may select one or more Leads as a Lead Compound(s) by giving
notice to the Parties of the JSC’s selection. Allergan will
promptly notify the JSC of the Data from the evaluation of Lead
Compounds against an Allergan Named Target. The JSC will evaluate
the Data and make a decision on selection of a Pre-Development
Compound and up to two (2) Backup Compounds.
3.11 At any time after the Effective Date, the JSC
may select a Backup Compound as a Pre-Development Compound by
giving notice to the Parties of the JSC’s
selection.
3.12 At any time after the Effective Date, the JSC
may designate a Pre-Development Compound as a Development Compound
by giving notice to the Parties of the JSC’s
designation.
3.13 In the event that (i) the JSC has not selected a
Lead Compound from a set of Leads against an Allergan Named Target
within [***]* of the Effective Date, or, at any earlier date that
the JSC decides to proceed under this Section 3.13, or (ii) during
the three (3) year term after the Effective Date that the JSC
decides, or after the three (3) year anniversary of the Effective
Date that Allergan decides, [***]* against an Allergan Named
Target, then with respect to such Lead Compound, Pre-Development
Compound, Back-Up Compound or Development Compound:
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a)
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the Parties
will negotiate in good faith regarding the possibility of [***]* in
the Field the Lead, Lead Compound, Pre-Development Compound,
Back-Up Compound or a Development Compound against an Allergan
Named Target, on terms to be mutually agreed upon;
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b)
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if after [***]* the Parties are
unable to agree upon the terms of [***]* the Lead, Lead Compound,
Pre-Development Compound, Back-Up Compound or a Development
Compound against an Allergan Named Target or otherwise do not wish
to [***]*, then Sirna will have the right to develop the Lead, Lead
Compound, Pre-Development Compound, Back-Up Compound or a
Development Compound, independently of Allergan, independently
and/or with one or more third parties, in which case Sirna will pay
to Allergan [***]* of Sirna’s Net Sales
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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of any Drug including the Lead,
Lead, Lead Compound, Pre-Development Compound, Back-Up Compound or
a Development Compound or any Drug including it, and will pay to
Allergan [***]* that Sirna receives from a Third Party Licensee in
connection with such Drug.
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c)
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Sirna may
credit against royalties and any other payments due to Allergan
under subsection b), above, an amount equal to [***]* of royalties
[***]* due by Sirna to any third party in the event that the
commercialization of any Drug sold pursuant to Section 3.13(b)
above is Covered (or allegedly Covered) by any patent (including
patents falling under the scope of the Tuschl License) claiming
[***]*. Sirna [***]* any single [***]* but may [***]* determined
pursuant to this section until such [***]* has been completely
utilized.
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Research and Development
Funding
3.14 Other than as set forth elsewhere in this
Agreement, Allergan will be responsible for funding all activities
related to the research and development, including clinical
development, of Compounds, Lead Compounds, Pre-Development
Compounds, and Development Compounds, against each of the Allergan
Named Targets. In addition, Allergan will be responsible for
funding all activities related to the commercialization worldwide
of Licensed Products in the Field.
Exclusivity of
Rights
3.15 For [***]* from the Effective Date, this
Agreement will be the [***]* of researching and developing [***]*
compounds and products for the treatment of any condition within
the Field. Allergan may [***]* use commercially available [***]*
reagents to validate targets, that is, to explore whether
inhibiting a target will result in a desired therapeutic effect in
a non-human animal.
3.16 Should a third party present to Allergan an
opportunity to collaborate in the field of RNAi-therapeutics, the
Parties will confer to discuss the possibility of the Parties
engaging in a similar such collaboration.
4. L ICENSE
4.1 Sirna grants to Allergan [***]* license under
the Sirna Patents to make (subject to Sirna’s manufacturing
rights set forth below), use, sell, and offer for sale in any
country of the world Licensed Products in the Field. Neither
Allergan nor Sirna will have the right to develop or commercialize
Licensed Products outside the Field without prior written consent
of the other Party.
4.2 Sirna grants to Allergan (a) [***]* license to
use in any country of the world any method or composition claimed
by the Sirna Patents, and (b) [***]* license to use in any country
of the
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*
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Indicates that
certain information contained herein has been omitted and filed
separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the
omitted portions.
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world any Sirna Know-How, to research in the
Field Lead Compounds, Development Compounds, Backup Compounds, and
Licensed Products.
4.3 Allergan may sublicense its rights under
Section 4 to any of its Affiliates. Allergan may sublicense
its rights under Section 4 to any other third-parties, subject
to Sirna’s written consent, such consent not to be
unreasonably withheld. Allergan will be responsible for the
performance of all obligations of any Third Party Licensees under
their respective sub-license agreements with Allergan.
4.4 Within [***]* of the Effective Date Sirna will
disclose to Allergan all [***]* in Sirna’s possession
necessary for the research and development of Sirna 027. Sirna will
disclose to Allergan all [***]* necessary for the research and
development of Lead Compounds, Development Compounds, and Licensed
Products within a reasonable period of time after Sirna obtains
rights to or becomes aware of such [***]*. Notwithstanding the
foregoing, Sirna will not be obligated to disclose to Allergan any
[***]* relating to its [***]* design, synthesis, delivery, process
development and manufacture.
4.5 Nothing in this Agreement herein will prevent
Sirna from independently or with one or more third parties
researching, developing, and commercializing RNAi-based products
against any of the Allergan Named Targets outside the Field, nor
does this Agreement confer on Sirna any rights under any
intellectual property Controlled by Allergan to research, develop
or commercialize such products.
4.6 Unless expr
