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Exhibit 10.42 COLLABORATIVE RESEARCH, SERVICES AND
LICENSE AGREEMENT This
COLLABORATIVE RESEARCH, SERVICES AND LICENSE AGREEMENT
("Agreement") is entered into as of December 21 2006 (the
"Effective Date") between:
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(1)
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PFIZER INC , a Delaware corporation, having an office at
235 East 42nd Street, New York, New York 10017 and its Affiliates
("Pfizer"), and
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(2)
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ARCHEMIX CORP. , a Delaware corporation, having an office
at 300 Third Street, Cambridge, Massachusetts 02142 and its
Affiliates ("Archemix").
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BACKGROUND:
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1.
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Archemix possesses proprietary expertise and know-how related to
the discovery, identification and optimization of Aptamers with the
potential for development as therapeutics for the treatment of
acute and chronic diseases; and
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2.
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Archemix owns or has been granted certain access to the patents
and patent applications set forth in Appendices D1 and D2 attached
to and made part of this Agreement with respect to the Aptamers and
discovery, identification, optimization and use of Aptamers;
and
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3.
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Pfizer has the capability to undertake research for the
discovery and evaluation of agents for treatment of disease and
also the capability for clinical analysis, manufacturing and
marketing with respect to therapeutic agents; and
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4.
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Pfizer and Archemix enter into this Agreement to collaborate on
the discovery of novel Aptamers with the potential for therapeutic
use in humans.
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THE PARTIES AGREE AS FOLLOWS:
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1.
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Defined Terms . The meanings of defined terms used
in this Agreement with an initial capital letter are listed in
Appendix A .
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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2.
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Collaborative Research Program .
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2.1
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Purpose . During the Research Program Term,
Archemix and Pfizer will conduct the Research Program. The
objective of the Research Program is to use Archemix Background
Technology and Archemix Background Patent Rights to identify Early
Leads and Optimized Leads against Program Targets as agreed in the
Research Plans for development and commercialization as Products. A
customized Research Plan will be established for each Program
Target detailing the tasks and responsibilities of each party.
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2.2
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Target Election .
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2.2.1
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Subject to Section 2.2.3 and 2.2.4, during the Research
Program Term, Pfizer may nominate Targets to be entered into up to
three (3) separate Research Plans within the Research Program, in
its sole discretion. Archemix will use commercially reasonable
efforts to commence work with respect to each Research Plan as
promptly as practicable after the proposed Target has been accepted
as a Program Target and the applicable Research Plan is approved.
Notwithstanding the foregoing, the parties hereby agree that
(a) the first Program Target will be designated, and the
Research Plan applicable thereto will be approved pursuant to
Section 2.4 within [***] days of the Effective Date;
(b) Archemix will not be obligated to commence work under the
Research Plan applicable to the second Program Target sooner than
[***] months from the date of approval of the Research Plan for the
first Program Target; and (c) Archemix will not be obligated to
commence work under the Research Plan applicable to the third
Program Target sooner than [***] months from the date of approval
of the Research Plan for the second Program Target. The right of
Pfizer to nominate Targets as Program Targets under this
Section 2.2.1 shall terminate on the third anniversary of the
Effective Date.
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2.2.2
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Pfizer shall have the right to nominate a Target as a Program
Target from the Target List or otherwise by giving Archemix written
notice in the form and containing solely the information set out in
Appendix B ("Target Nomination Notice").
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2.2.3
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Archemix may reject the nomination of a Target as a Program
Target only if:
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(a)
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Archemix is prohibited, under the terms of a written agreement
with a third party entered into prior to Archemix’s receipt
of the Target Nomination Notice, from performing research on:
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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2
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(ii)
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in the case of multi-subunit Targets, any individual subunit of
the Target; or
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(iii)
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in the case of Targets that function as part of a binding pair
(e.g., ligand-receptor), any interaction partners; or
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(b)
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Archemix has, at the time of receipt of the Target Nomination
Notice, an active internal research program or collaborative
program, as supported by credible evidence, directed towards:
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(i)
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the Target;
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(ii)
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in the case of multi-subunit Targets, any individual subunit of
the Target; or
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(iii)
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in the case of Targets that function as part of a binding pair
(e.g., ligand-receptor), any interaction partners; or
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(c)
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Archemix is negotiating a term sheet with a third party, as
supported by credible evidence, with respect to an agreement
relating to Aptamers against:
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(i)
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the Target;
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(ii)
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in the case of multi-subunit Targets, any individual subunit of
the Target; or
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(iii)
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in the case of Targets that function as part of a binding pair
(e.g., ligand-receptor), any interaction partners.
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2.2.4
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Archemix shall give Pfizer written notice of the rejection or
acceptance of any Target proposed by Pfizer within [***] business
days of receiving the Target Nomination Notice. In addition,
Archemix will advise Pfizer in writing on the feasibility of
generating Products from any such nominated Target that is not so
rejected based upon its previous experience and Aptamer expertise
within [***] days of receiving the Target Nomination Notice (each,
a "Feasibility Report"). Within [***] business days of
Pfizer’s receipt of each such Feasibility Report, Pfizer will
provide Archemix with written notice as to whether or not it wishes
to proceed with such nominated Target. Archemix shall give Pfizer
prompt written notice during the Research Program Term if any of
the restrictions on any Target that is rejected by Archemix
pursuant to Section 2.2.3 lapse, or are otherwise terminated,
such that the previously rejected Target becomes eligible for
nomination as a Program Target. If Archemix rejects a Target under
Section 2.2.3 or if Pfizer elects not to proceed following
receipt of a Feasibility Report, Pfizer will be permitted to
propose a new Target for each such rejection.
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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2.2.5
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Upon Archemix’s notification to Pfizer of Target
acceptance, Archemix shall advise Pfizer whether Archemix has
previously licensed to a third party the right to commercialize an
Aptamer directed to the Target for use as a [***]. In any such
circumstance, Pfizer may within [***] days, in its sole discretion,
withdraw the Target and propose a new Target from the Target List
or otherwise, subject to the limitations set forth in
Section 2.2.1. If Pfizer elects to enter the Target as a
Program Target into the Research Program, Pfizer will acknowledge
and covenant in the relevant Research Plan that it does not [***]
and [***] a [***] that Program Target for use as a [***].
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2.3
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Target List . During the Research Program Term,
Pfizer shall set forth on Appendix E up to [***]
Targets as potential Program Targets (the "Target List"). Pfizer
shall have the right to request that a Target be added to the
Target List or that a Target on the Target List be replaced by
providing written notice to Archemix at any time during the
Research Program Term for any Target for which the initiation of
the Research Plan has not yet begun; provided, that, at no time
shall there be more than [***] Targets on the Target List at any
one time. Archemix shall accept or reject the proposed Target in
accordance with Section 2.2.3, 2.2.4 and 2.2.5. During the
Research Program Term, Archemix will use commercially reasonable
efforts to inform Pfizer promptly in [***] if it [***]to [***] with
a [***] with [***] to a [***]or [***] relating to [***] a [***] on
the [***]. Our proposed redactions are consistent with SEC guidance
we have received in the past
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2.4
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Research Plans .
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2.4.1
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The Research Committee (as defined in Section 2.6) will,
within [***] days of Archemix’s acceptance of a proposed
Target as a Program Target, but before any work begins on any such
Program Target, prepare and adopt a Research Plan for each such
Program Target entered into the Research Program.
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2.4.2
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Each Research Plan will be consistent with the example plan
attached as Appendix C (the "Example Plan") and include
the Early Lead Criteria (ELC), Optimized Lead Criteria
(OLC) and a target product profile (TPP) applicable to
each Program Target. The ELC, OLC and TPP will be defined through
joint discussions between Pfizer and Archemix and approved by the
Research Committee, and will take into consideration the ELC, OLC
and TPP Selection Factors and any other relevant requirements.
Under no circumstances shall Archemix be obligated to perform any
work in addition to the work contemplated by the Example Plan
without Archemix’s written consent. Amendments to any
Research Plan shall be prepared and adopted by the Research
Committee and shall be attached to the minutes of the meeting of
the Research Committee at which such amendment, modification or
update was approved.
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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2.4.3
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The Research Plan will be performed by project teams consisting
of appropriately qualified members of each party. Project teams
will communicate on an at least monthly basis by teleconference,
videoconference, or face-to-face meeting.
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2.4.4
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Pfizer may terminate a Research Plan at anytime by giving
Archemix [***] days’ prior written notice ("Research Plan
Discontinuation"). If any Research Plan Discontinuation is made
[***], Pfizer shall make the payment described in [***] in
accordance with [***], and such [***] under the applicable Research
Plan.
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2.5
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Exclusivity . During the Term of this Agreement,
and providing that Pfizer exercises commercially reasonable efforts
as described in Section 2.10, Archemix will not perform for
third parties or sponsor research internally or with third parties
directed to the discovery or development of Aptamers that bind to
Program Targets; provided, that, nothing in this Section 2.5
shall limit or restrict Archemix from (a) developing or
commercializing [***] in accordance with Section 2.2.5 or
(b) performing Permitted Screening Activities. For purposes of
clarity, (a) if Program Targets function as part of a [***]
under this Section 2.5 is [***]to [***] and (b) in the
[***] of [***] under this Section 2.5 [***] to [***] of
the[***].
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2.6
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Research Committee .
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2.6.1
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Purpose . Pfizer and Archemix hereby establish a
Research Committee to:
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(a)
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review and evaluate the Research Program’s progress;
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(b)
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prepare the Research Plan for each Program Target;
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(c)
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amend each Research Plan to the extent necessary during the
Research Program Term;
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(d)
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coordinate the publication of the Research Program’s
results so as to preserve all potential Patent Rights of the
parties;
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(e)
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determine whether Aptamers meet the ELC or OLC;
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(f)
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monitor the exchange of information and materials between the
parties;
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(g)
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resolve any disputes between the parties with respect to any
Research Plan; and
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(h)
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making such other decisions as may be delegated to the Research
Committee by the parties.
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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2.6.2
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Membership . Pfizer and Archemix each hereby
appoints [***] members to the Research Committee. A party may
replace one of its members at any time. Other representatives of
Archemix or Pfizer may attend meetings if invited by either
party.
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The initial members are:
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Pfizer Members: [***]
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Archemix Members: Page Bouchard
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Sharon
Cload
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Anne
Wong
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2.6.3
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Co-Chairs . The parties will appoint one member
each to co-chair the Research Committee.
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2.6.4
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Meetings . The Research Committee will meet not
less than quarterly, with at least two meetings in each Commitment
Year being in person. The parties will take turns in selecting the
date and location of the meetings.
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2.6.5
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Minutes . The Research Committee will keep
accurate minutes of its deliberations. The minutes will record all
decisions and proposed actions. A draft of the minutes shall be
delivered to all Research Committee members within [***] business
days after each meeting. The party hosting the meeting will prepare
and circulate the draft minutes. The co-chairs will edit and
approve the minutes.
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2.6.6
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Decisions . All decisions of the Research
Committee will be made by consensus. In the event that no consensus
can be reached by the Research Committee with respect to a matter
despite the reasonable good faith efforts of the members, then
Pfizer will have the right to make the final decision, but shall
only exercise such right in good faith after full consideration of
the positions of both parties.
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2.6.7
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Expenses . Each of Pfizer and Archemix will bear
all expenses incurred by its respective members participating on
the Research Committee.
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2.6.8
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Research Committee Term . The term of the Research
Committee shall commence on the Effective Date and shall terminate
on the termination or expiration of the Research Program Term.
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2.7.1
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Quarterly Reports . At least one week prior to
each Research Committee meeting, each party will submit to the
Research Committee a written
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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report detailing and evaluating its activities under the
Research Plan since the last Research Committee meeting.
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2.7.2
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Comprehensive Written Reports . A comprehensive
written report will be provided by each party to the Research
Committee within [***] days after completion of each Research Plan.
The report will describe in detail the accomplishments and evaluate
the results of Research Plan.
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2.8
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Exchange of Proprietary Materials . During the
term of the Research Plan, the parties will supply to each other
samples of Proprietary Materials as required by the Research
Plan.
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2.9
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Laboratory Facility and Personnel . Each party
will provide adequate laboratory facilities, equipment and
personnel for the work to be done by it in the Research
Program.
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2.10
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Diligence .
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(a)
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During the Research Program Term, Pfizer and Archemix will each
use commercially reasonable efforts to achieve the objectives of
the Research Program described in Section 2.1.
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(b)
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During the Term, Pfizer will use commercially reasonable efforts
to develop Optimized Leads and to commercialize Products.
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(c)
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In the case of Pfizer, commercially reasonable efforts shall
include, with respect to the activities of Pfizer (i) during
the Research Program Term and (ii) during the development of
Optimized Leads and the development and commercialization of
Products, the efforts and resources that Pfizer would use if it
were researching, developing or commercializing its own
pharmaceutical products that are of similar market potential as the
Products, taking into account product labeling, present and future
market potential, financial return, present and the reasonable
anticipated future regulatory environment and competitive market
conditions, all as measured by the facts and circumstances at the
time such efforts are due.
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(d)
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In the case of Archemix, commercially reasonable efforts shall
include, with respect to the activities of Archemix in the Research
Program, the efforts and resources comparable to those undertaken
by Archemix in pursuing the research and discovery of product
candidates that are not subject to the Research Program and that
have similar market potential.
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2.11
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Responsibilities of Pfizer . Pfizer will have the
sole responsibility for the development of the Products following
the achievement of OLC for each Program Target, including all
preclinical, clinical, regulatory and commercialization activities
relating to the Products.
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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2.12
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Assistance of Archemix . Upon Pfizer’s
request, Archemix may, in its sole discretion, provide any
technical assistance that Archemix is reasonably capable of
providing to enable Pfizer or its sublicensees, to identify,
develop, manufacture, sell, offer for sale, or import Products. To
the extent such activities are part of the Research Program it
shall be provided in accordance with the terms set forth in
Section 3.2 and to the extent such technical assistance
involves any other matters such as CMC technical expertise, it
shall be provided by Archemix upon mutually agreeable terms.
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3.
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Research Program Payments .
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3.1
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Technology Access Fee . Within thirty
(30) days of the Effective Date, Pfizer shall pay to Archemix
a non-refundable, non-creditable technology access fee in the
amount of $6,000,000.
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3.2
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Research Support . At any time during the Research
Program Term, Pfizer may request in writing (each, a "Pfizer
Research Request") that Archemix perform, and Archemix may in its
sole discretion agree to perform, work within the Research Program
above and beyond the work specified in the Example Plan (including
without limitation any work agreed to by Archemix pursuant to
Section 2.12). In such case, the provisions of
Section 3.5 shall apply.
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3.3
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Development of a Surrogate Aptamer . Upon the
decision of the Research Committee, Archemix will develop a
Surrogate Aptamer against any Program Target as designated by the
Research Committee. For each Surrogate Aptamer so designated,
(a) an appropriate research plan will be agreed to by the
parties to include such Surrogate Aptamer and (b) Pfizer will
pay Archemix $[***] upon initiation of the work, and $[***] upon
delivery of the Surrogate Aptamer to Pfizer.
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3.4
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Research Milestones .
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3.4.1
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Milestone Events . —
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Event
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Payment
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[***]
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$[***]
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[***]
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$[***]
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3.4.2
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Payment of Milestones . For each Research Plan, if
a Research Milestone listed in Section 3.4.1 is achieved,
Pfizer shall pay Archemix the sum noted for that Research Milestone
in accordance with Section 7.4. The parties understand and agree
that [***] and [***] will be paid by Pfizer per Research Plan.
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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3.5
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Research Payments . If Archemix agrees to perform
work pursuant to Section 3.2, the following provisions will
apply:
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3.5.1
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Research Payments . Pfizer shall pay Archemix the
aggregate FTE Cost for all FTEs expended by Archemix in activities
under this Section 3.5.1, based on the FTE Rate, such payments
to be made [***] as agreed to in the Research Plan. At the time(s)
agreed to by the parties, Archemix shall provide Pfizer with
reconciliation statements that specify the actual number of FTEs
used by Archemix.
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3.5.2
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Audit Rights .
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(i)
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Records . Archemix shall keep accurate records pertaining
to the number of FTEs utilized in the conduct of the Research Plan
and in conducting the work requested by Pfizer pursuant to section
3.2. The records shall conform with general accounting principles.
The records for each Commitment Year shall be retained by Archemix
for at least [***] years from the end of that Commitment Year.
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(ii)
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Audit Rights . During the Research Program Term and for
[***] years thereafter, Pfizer may, at its own expense, appoint an
independent, certified public accountant to audit the records kept
by Archemix pursuant to Section 3.5.2(i). The accountant shall
be reasonably acceptable to Archemix.
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(iii)
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Notice and Place . Before inspecting the records, Pfizer
shall give Archemix not less than [***] days’ written notice.
Archemix shall make the records available for the inspection during
regular business hours at the place where the records are usually
kept.
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(iv)
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Findings . The accountant’s findings will be
reported to both parties and will be binding on the parties.
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(v)
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Timing and Frequency . Pfizer may only audit the records
once each calendar year and may only audit the records for any
period once. If, Pfizer does not audit the records of a Commitment
Year within [***] years after the end of that year, Pfizer will be
deemed to have accepted the accuracy of the records.
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(vi)
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Confidentiality . All information learned by Pfizer
during an inspection will be deemed to be Archemix’s
Confidential Information.
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3.6
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External R&D Costs . In addition to the
funding obligations in Section 3 above, Pfizer shall [***] for the
payment of [***] third party research and development activity
costs ("Third Party Costs"), including, without limitation, [***],
incurred by Archemix or Pfizer to the extent set forth in a
Research Plan or otherwise
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Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
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approved by Pfizer or the Research Committee. Unless otherwise
agreed, Pfizer will reimburse Archemix for [***] such Third Party
Costs in accordance with the provisions of Section 7.4.
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3.7
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Research Plan Discontinuation . In the event of
Research Plan Discontinuation as described in Section 2.4.4,
and at the time set forth in Section 2.4.4, Pfizer shall[***].
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3.8
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Exchange of Reports; Information; Updates .
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3.8.1
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Development Reports . Pfizer shall keep the
Archemix regularly informed of the progress of its efforts to
develop and commercialize Optimized Leads and Products by providing
Archemix with a summary on an annual basis regarding milestone
events.
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3.8.2
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Adverse Events . In addition to the updates
described in Section 3.8.1, Pfizer will endeavor to advise
Archemix of any adverse event believed to have class effects prior
to public disclosure of same.
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3.8.3
|
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Product Recalls . In the event that any regulatory
authority issues or requests a recall or takes similar action in
connection with a Product, Pfizer will endeavor to provide Archemix
with notice prior to public disclosure of same.
|
|
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3.8.4
|
|
No Breach Event . For purposes of clarity, the
failure of Pfizer to comply with Section 3.8.2 or 3.8.3 shall
not constitute a Breach Event for purposes of this Agreement.
|
|
4.
|
|
Treatment of Confidential Information .
|
|
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4.1.1
|
|
Except as provided in Sections 4.1.2, 4.1.3, 4.1.4 and
4.1.5 below, a party may not disclose and will cause its Affiliates
and sublicensees not to disclose, to a third party the following
information without the written permission of the other party:
|
|
|
(a)
|
|
the other party’s Confidential Information;
|
|
|
|
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|
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(b)
|
|
the other party’s Program Technology; or
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(c)
|
|
the terms of this Agreement.
|
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4.1.2
|
|
If a party is required by Applicable Laws to disclose
information described in Section 4.1.1, it shall use
commercially reasonable efforts to give the other party prompt
notice and cooperate with the other party if the other party seeks
— at its expense — a protective order; provided, that,
a
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| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
10
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|
|
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party may, without the other party’s permission, disclose
such information that its legal counsel reasonably advises it is
required to disclose or if the other party either waives compliance
with Section 4.1.1 or fails to timely obtain such protective
order.
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4.1.3
|
|
Each of Pfizer and Archemix may disclose the other’s
Confidential Information (a) to its respective officers,
employees, board of directors and consultants who participate in
the Research Program; (b) to investors and potential investors
and agents who are bound by contract to maintain the information in
confidence and not to use such information except as expressly
permitted hereunder; (c) on a need-to-know basis to such other
party’s legal and financial advisors, (d) as reasonably
necessary in connection with an actual or potential debt or equity
financing of such other party or (e) for any other purpose with the
other party’s written consent, not to be unreasonably
withheld, conditioned or delayed.
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4.1.4
|
|
A party may disclose the information described in Section 4.1.1
to a third party: (a) for use under a sublicense that the
party is entitled to grant under this Agreement; or
(b) approved in advance in written form by the parties to
provide services to support the Research Program. The third party
shall be bound by contract to maintain such information in
confidence on the same terms as are set forth in this
Section 4.
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4.2
|
|
Use . Pfizer and Archemix may use, and will cause
its Affiliates and sublicensees to use, the other’s
Confidential Information only as permitted by this Agreement.
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4.3
|
|
Measures . Each of Pfizer and Archemix will use
the same measures to protect the other’s Confidential
Information as it uses to protect its own Confidential Information.
Each party shall ensure that each of its officers, employees,
directors, consultants, investors, potential investors and
consultants that will have access to the other’s Confidential
Information are bound by contract to maintain the information in
confidence.
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4.4
|
|
Return of Information . After termination of this
Agreement, a party will return or destroy all copies of the
other’s Confidential Information and Proprietary Materials
when requested by the other party; provided, that, one copy of such
Confidential Information may be kept so that the party can monitor
its continuing obligations under this Agreement. All such
Confidential Information and Proprietary Materials will be returned
within [***] days of the request.
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4.5
|
|
Publication . The results of the Research Program
may be published as part of a scientific presentation or
publication after scientific review by the Research Committee if
neither Archemix nor Pfizer — acting reasonably —
disapproves the publication in writing:
|
|
|
(a)
|
|
within [***] days of receipt of the proposed publication if it
is a manuscript; or
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
11
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(b)
|
|
within [***] days of receipt of the proposed publication if it
is an abstract or transcript to be included in the proceedings of a
scientific meeting.
|
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|
|
Notwithstanding the foregoing, each party shall have the right
to require that any of its Confidential Information that is
disclosed in any such proposed publication or presentation be
deleted prior to such publication or presentation.
|
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4.6
|
|
Duration . The obligations of this Section 4
will end [***] years after the termination or expiration of the
Research Program.
|
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4.7
|
|
Other Information . The restrictions in this
Section 4 do not apply to information that (a) as of the
date of disclosure, it is known to the receiving party or its
Affiliates as demonstrated by contemporaneous credible written
documentation, other than by virtue of a prior confidential
disclosure to such receiving party; (b) as of the date of
disclosure it is in the public domain, or it subsequently enters
the public domain through no fault of the receiving party; or
(c) is obtained by the receiving party from a third party
having a right to make such disclosure free from any obligation of
confidentiality to the disclosing party.
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4.8
|
|
Publicity . Notwithstanding anything to the
contrary in Section 4, either party may upon written approval
of the other party issue a press release with respect to this
Agreement as soon as practicable after the Effective Date and
either party may make subsequent public disclosure of the contents
of such press release without further approval of the other party.
After issuance of such press release, except as required by
Applicable Laws, neither party shall issue a press or news release
or make any similar public announcement related to the Research
Program without the prior written consent of the other party.
|
|
5.
|
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Restrictions on Proprietary Materials .
|
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5.1
|
|
A party may transfer the other party’s Proprietary
Materials to a third party:
|
|
|
(a)
|
|
for use under a sublicense that the party is entitled to grant
under this Agreement; or
|
|
|
|
|
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|
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(b)
|
|
that is approved by the parties to provide services to support
the Research Program.
|
|
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5.2
|
|
Otherwise, a party may not transfer the other party’s
Proprietary Materials to a third party without the written
permission of the other party, which approval shall not be
unreasonably withheld.
|
|
6.
|
|
Intellectual Property Rights; Grant of Licenses
.
|
|
|
6.1
|
|
Disclosure of Inventions . Each party shall
promptly inform the other party about all inventions that its
officers, employees, agents or consultants conceive or reduce to
practice in the conduct of the Research Program.
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
12
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6.2
|
|
Ownership . Pfizer will own all Pfizer Program
Technology, Pfizer Program Patent Rights, Pfizer Background
Technology and Pfizer Background Patent Rights, and Archemix will
own all Archemix Program Technology, Archemix Program Patent
Rights, Archemix Background Technology and Archemix Background
Patent Rights. In case of a dispute between Archemix and Pfizer
over inventorship and, as a result, whether any particular
Technology is Pfizer Program Technology, Pfizer Program Patent
Rights, Archemix Program Technology and/or Archemix Program Patent
Rights, the parties shall attempt in good faith to resolve such
dispute through discussions and shall consider the designation of a
U.S. patent counsel to render an opinion with respect to such
dispute who (and whose firm) is not at the time of the dispute, and
was not at any time during the [***] years prior to such dispute,
performing services for either of the parties, such patent counsel
to be selected by the parties. Expenses of such patent counsel
shall be [***] the parties.
|
|
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|
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6.3
|
|
Archemix Research License . Subject to the terms
and conditions of this Agreement, Pfizer hereby grants to Archemix,
under Pfizer’s rights in Pfizer Background Technology, Pfizer
Program Technology, Pfizer Background Patent Rights and Pfizer
Program Patent Rights, a nonexclusive, worldwide, royalty-free,
perpetual license, including the right to grant sublicenses, to
Affiliates, for research purposes. For clarification purposes, this
license does not include any right to use Pfizer Background
Technology, Pfizer Program Technology, Pfizer Background Patent
Rights or Pfizer Program Patent Rights in the sale or manufacture
for sale to third parties of products, processes or services.
|
|
|
|
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|
|
6.4
|
|
Pfizer Research License . Subject to the terms and
conditions of this Agreement, Archemix hereby grants to Pfizer,
under Archemix’s rights in Archemix Background Technology,
Archemix Program Technology, Archemix Background Patent Rights, and
Archemix Program Patent Rights, a nonexclusive, worldwide,
royalty-free, perpetual license, including the right to grant
sublicenses, to Affiliates, for research purposes; provided, that,
with respect to Archemix Background Patent Rights and Archemix
Program Patent Rights (i) the license granted in this
Section 6.4 only includes Patent Rights that cover [***] to
[***] in the course of the [***] and (ii) to the extent that
Pfizer develops any [***] to [***] such [***] of such [***] under
the license granted in this Section 6.4,[***]Pfizer hereby
grants to Archemix [***] license, [***], to research, develop,
manufacture, use, sell, offer for sale and import products for any
and all uses. For clarification purposes, this license does not
include the rights to use (a) Archemix Background Technology,
Archemix Program Technology, Archemix Background Patent Rights, or
Archemix Program Patent Rights in the sale or manufacture for sale
of products, processes or services; or (b) the SELEXTM Process
or SELEXTM Technology for any purpose.
|
|
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|
|
|
|
|
6.5
|
|
Commercial License Granted to Pfizer . Subject to
the terms and conditions of this Agreement, Archemix hereby grants
to Pfizer an exclusive, royalty-bearing, worldwide license, under
the Archemix Background Technology, Archemix
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
13
|
|
|
|
Program Technology, Archemix Background Patent Rights, and
Archemix Program Patent Rights, including the right to grant
sublicenses as described in Section 6.5.3, to manufacture,
use, sell, offer for sale and import Products, but not Diagnostic
Products.
|
|
|
6.5.1
|
|
Term of License . Unless terminated earlier under
this Agreement, the term of the license in Section 6.5 will
end on the expiration of the last Royalty Term.
|
|
|
|
|
|
|
|
6.5.2
|
|
Paid-Up License . Pfizer will have a paid-up,
royalty free, non-exclusive license under the grant in
Section 6.5 to manufacture, use, sale, offer for sale and
import any Product in a country after the expiration of the Royalty
Term applicable to such Product in such country.
|
|
|
|
|
|
|
|
6.5.3
|
|
Sub-Licenses . If Pfizer wishes to grant a
sublicense pursuant to this Section 6.5, (a) Pfizer shall
guarantee that any sublicensee fulfills all of Pfizer’s
obligations under this Agreement; provided, however, that Pfizer
shall not be relieved of its obligations pursuant to this
Agreement; (b) it shall be a condition of any such sublicense
that such sublicensee agrees to be bound by all terms of this
Agreement applicable to the commercialization of Products; and
(c) Pfizer shall use reasonable efforts to provide advance
written notice to Archemix of any such proposed sublicense and
following execution thereof, provide copies to Archemix of each
such sublicense.
|
|
|
6.6
|
|
Discontinued Targets . In the event that Pfizer
decides to discontinue pursuit of a particular Program Target with
Archemix, then Pfizer shall grant Archemix a non-exclusive,
worldwide, royalty-free license, including the right to grant
sublicenses, against such Target under all Pfizer’s right,
title, and interest in the Pfizer Program Technology and Pfizer
Program Patent Rights, to research, develop, manufacture, use,
sell, offer for sale and import Aptamers other than Program
Aptamers and/or products derived from Aptamers other than Program
Aptamers against such Target for any and all uses, except as
otherwise provided herein.
|
|
|
|
|
|
|
|
6.7
|
|
License to Certain Program Patent Rights . Pfizer
hereby grants to Archemix a non-exclusive, perpetual, worldwide,
royalty-free license under the Pfizer Aptamer-Generic Program
Technology and Pfizer Aptamer-Generic Program Patent Rights to
research, develop, manufacture, use, sell, offer for sale and
import products for any and all uses, except as otherwise provided
herein.
|
|
|
|
|
|
|
|
6.8
|
|
Joint Technology Rights . The parties will [***]
Joint Aptamer-Generic Program Technology and Joint Aptamer-Generic
Patent Rights. Notwithstanding anything to the contrary contained
in this Agreement or under Applicable Law, except to the extent
exclusively licensed to one party under this Agreement, the parties
hereby agree that either party may use or license or sublicense to
Affiliates or third parties [***] Joint Aptamer-Generic Program
Technology and/or Joint Aptamer-Generic
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
14
|
|
|
|
Program Patent Rights [***] the other party, [***] and [***] the
other party, except as otherwise provided under this Agreement.
|
|
7.
|
|
Payments . In addition to Pfizer’s payment
obligations set forth in Section 3 and in return for
Archemix’s contribution to the development of Program Patent
Rights and Program Technology under this Agreement, Pfizer will
make the following non-refundable payments to Archemix within [***]
days after the occurrence of each of the following milestone
events:
|
|
|
7.1
|
|
Milestone Payments . If a Product achieves a
Milestone Event described in this Section 7.1, Pfizer will pay
Archemix the sum noted for that milestone on a Target-by-Target
basis, unless: (a) [***] and [***] Archemix; or (b) [***]
[***].
|
Milestones
|
|
|
|
|
|
|
Milestone
|
|
Event
|
|
Payment ($)
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
|
|
|
[***]
|
|
[***]
|
|
|
7.2
|
|
Skipped Milestones . In the event that one or more
of the above milestones for a Product is skipped but a subsequent
milestone is achieved for the same Product, the amounts payable for
the skipped milestones [***] the payment of the next milestone.
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
15
|
|
7.3
|
|
Royalties on Net Sales . Pfizer will pay Archemix
a royalty of [***] ([***]%) percent of Annual Net Sales of each
Product in each country until the expiration of the Royalty Term
for such Product.
|
|
|
7.3.1
|
|
End of Royalties . Pfizer’s obligation to
pay Royalties will end in each country upon expiration of the
Royalty Term for such Product.
|
|
|
|
|
|
|
|
7.3.2
|
|
Deduction of Creditable Milestones from Royalty
Payment . The full sum of all milestone payments paid by
Pfizer with respect to a Product ("Credit") as listed in
Section 7.1 above shall be deducted from the Royalty payments
made with respect to that Product subject to the following
conditions:
|
|
|
(a)
|
|
in any Pfizer Quarter, the Royalty payment shall not be reduced
by this Credit by more than [***]% of the Royalty payment otherwise
due; and
|
|
|
|
|
|
|
|
(b)
|
|
any remaining outstanding Credit [***] until such Credit has
been fully paid.
|
|
|
7.3.4
|
|
Currency Conversion . All Royalties will be
computed and paid in U.S. dollars. Conversion of sales recorded in
currencies other than the U.S. dollar to U.S. dollar for the
purposes of computing the Royalty rate to be applied as well as the
amount of Royalties due will be performed in a manner consistent
with Pfizer’s normal practices used to prepare its audited
financial statements for external reporting purposes; provided that
(a) such practices use a widely accepted source of published
exchange rate and (b) Pfizer provides Archemix with written notice
of the method and source of conversion at the time of such
payment.
|
|
|
7.4.1
|
|
Unless otherwise specified herein, all payments specified herein
will be made in U.S. currency within [***] days of receipt of
invoice.
|
|
|
|
|
|
|
|
7.4.2
|
|
Royalty payments on Net Sales will be made within [***] days
after the end of each Pfizer Quarter in which the Net Sales are
made by Pfizer or any sublicensee. These payments shall be
accompanied by a statement showing:
|
|
|
(a)
|
|
the Net Sales of each Product by Pfizer or any sublicensee of
Pfizer in each country;
|
|
|
|
|
|
|
|
(b)
|
|
the basis of any deduction from Net Sales;
|
|
|
|
|
|
|
|
(c)
|
|
the applicable Royalty rate for the Product; and
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
16
|
|
(d)
|
|
a calculation of the amount of Royalty due, including any
offsets.
|
|
|
7.5.1
|
|
Tax Cooperation . The parties hereby agree to
provide reasonable assistance and cooperation and to produce on a
timely basis any reports or other information in connection with
any payments made by Pfizer to Archemix for purposes of allowing
the other party to effectively comply with the reporting
requirements of the various taxing jurisdictions, to obtain refunds
of any taxes paid or withheld in those jurisdictions, or to
otherwise allow Archemix to claim such payment of taxes. Each party
further agrees to extend such assistance and cooperation to the
other party, at the other party’s expense, in connection with
any official or unofficial inquiries or audits by such taxing
jurisdictions relating to any payments made by Pfizer under this
Agreement.
|
|
|
|
|
|
|
|
7.5.2
|
|
Tax Matters . The parties agree that under any
applicable U.S. law or regulation if any of the payments made by
Pfizer in connection with this Agreement are subject to withholding
taxes such payments made by Pfizer shall be reduced by the amount
of tax required to be withheld and Pfizer shall pay the amount of
such taxes pursuant to the applicable law or regulation. The
parties further agree that if any applicable law or regulation of
any jurisdiction other than the United States requires the
withholding or payment of any taxes by Pfizer or any of its
sublicensees on Net Sales pursuant to Section 8.4, any such
taxes required to be paid or withheld shall be an expense to be
borne by Archemix and under no circumstances shall Pfizer become
liable for any further payments under the Agreement due to any
taxes required to be deducted, withheld, or paid. Under such
circumstances Pfizer shall withhold or pay such amounts on behalf
of Archemix and provide Archemix with an official tax certificate
or other evidence of such tax obligation along with proof of
payment unless under the applicable laws or regulations such
payments can lawfully be avoided.
|
|
|
7.6
|
|
Records and Inspection .
|
|
|
7.6.1
|
|
Records . Pfizer and any sublicensees shall keep
accurate records of its Net Sales of each Product. The records
shall conform to United States generally accepted accounting
principles. The records shall be retained for at least [***] years
from the date of each Royalty payment.
|
|
|
|
|
|
|
|
7.6.2
|
|
Inspection . For [***] years after receiving any
Royalty payment, Archemix may, at its own expense, appoint an
independent, certified public accountant to inspect and audit the
records relevant to this Agreement. The accountant shall be
reasonably acceptable to Pfizer.
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
17
|
|
7.6.3
|
|
Notice and Place . Before inspecting the records
Archemix shall give Pfizer reasonable notice. Pfizer shall make the
records available for the inspection during regular business hours
at the place where the records are usually retained.
|
|
|
|
|
|
|
|
7.6.4
|
|
Findings . The accountant’s findings will be
[***] on the parties.
|
|
|
|
|
|
|
|
7.6.5
|
|
Timing and Frequency . Archemix may only inspect
or audit the records once each calendar year and may only inspect
or audit the records for any Royalty payment once. If Archemix does
not inspect or audit the records for a Royalty payment within [***]
years of the payment being made, Archemix will be deemed to have
accepted the accuracy of the records.
|
|
|
|
|
|
|
|
7.6.6
|
|
Confidentiality . All information learned by
Archemix during an inspection will be deemed Pfizer’s
Confidential Information.
|
|
|
|
|
|
|
|
7.6.7
|
|
Discrepancies . Any discrepancy will be promptly
corrected by a payment or a credit, as appropriate. In the event
that the results of such audit reveal an underpayment of [***]
percent ([***]%) or more, then all reasonable audit fees will be
paid by Pfizer.
|
|
8.
|
|
Filing, Prosecution and Maintenance of Patent Rights
.
|
|
|
8.1.1
|
|
Pfizer may, at its sole discretion, file, prosecute, maintain
and enforce the Pfizer Background Patent Rights and Pfizer Program
Patent Rights. Pfizer shall use commercially reasonable efforts to
file, prosecute, maintain and enforce the Pfizer Program Patent
Rights in those countries and territories in which Pfizer
customarily pursues patent protection for products of similar
market potential as the Product. At Pfizer’s request,
Archemix shall cooperate with Pfizer in all reasonable respects in
connection with such preparation, filing, prosecution and
maintenance of such Pfizer Program Patent Rights, including but not
limited to obtaining assignments to reflect chain of title
consistent with the terms of this Agreement, gaining United States
patent term extensions, supplementary protection certificates and
any other extensions that are now or become available in the future
wherever applicable to Pfizer Program Patent Rights. For purposes
of clarity, notwithstanding anything to the contrary herein, Pfizer
shall have no rights to prepare, file, prosecute and/or maintain
any Patent Rights that are Archemix Background Patent Rights or
Archemix Program Patent Rights.
|
|
|
|
|
|
|
|
8.1.2
|
|
If Pfizer abandons or allows to lapse in any country any of the
Patent Rights comprising issued patents covering any Pfizer Program
Technology, and such Patent Rights would reasonably have provided
market exclusivity for the Product, Pfizer shall continue to pay
Archemix
|
| |
|
|
|
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
|
18
|
|
|
|
the royalties specified in Section 7.3 on Net Sales of
Products in such country.
|
|
|
8.2.1
|
|
Archemix may, at its sole discretion, file, prosecute, maintain
and enforce the Archemix Background Patent Rights, Archemix Program
Patent Rights and Joint Aptamer-Generic Patent Rights.
|
|
|
|
|
|
|
|
8.2.2
|
|
If Archemix decides to abandon or to allow to lapse any of the
Patent Rights covering any Archemix Aptamer-Generic Patent Rights
or Joint Aptamer-Generic Patent Rights, it shall inform Pfizer of
such decision promptly
|
|