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EXHIBIT 10.48
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.]
STRATEGIC ALLIANCE AGREEMENT
BETWEEN
PARTNERS HEALTHCARE SYSTEM, INC.,
THE GENERAL HOSPITAL CORPORATION,
D.B.A. MASSACHUSETTS GENERAL HOSPITAL,
THE XXXXXXX AND WOMEN'S HOSPITAL, INC.
AND
DECODE GENETICS LTD.
DATED MAY 11, 2000
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STRATEGIC ALLIANCE AGREEMENT
THIS STRATEGIC ALLIANCE AGREEMENT (together with all schedules and
appendices, this "Agreement"), dated as of May 11, 2000 ("Effective Date"), by
and among Partners HealthCare System, Inc. a not-for-profit corporation with its
principal place of business at Prudential Tower, 000 Xxxxxxxx Xxxxxx, Xxxxxx,
Xxxxxxxxxxxxx, 02199-8001("Partners"); The General Hospital Corporation d.b.a.
Massachusetts General Hospital, a Massachusetts not-for-profit corporation
having its principal offices at 00 Xxxxx Xxxxxx, Xxxxxx, XX 00000 ("MGH"); The
Xxxxxxx and Women's Hospital, Inc., a Massachusetts not-for-profit corporation
having its principal offices at 00 Xxxxxxx Xxxxxx, Xxxxxx, XX 00000 ("BWH")
(BWH, Partners and MGH are each, individually, an "Institution" and,
collectively, the "Institutions"); and deCODE genetics Ltd., an Icelandic
corporation which is a wholly-owned subsidiary of deCODE genetics, Inc., a
Delaware corporation, and having its principal offices at Xxxxxxxxx 0, XX-000
Xxxxxxxxx, Xxxxxxx ("deCODE") creates a collaborative relationship governed by
the terms and agreements contemplated under this Agreement, hereinafter referred
to as the "Alliance." Partners, MGH, BWH and deCODE are each, individually, a
"Party" and, collectively, the "Parties."
BACKGROUND
A. deCODE is building a database based on phenotypic healthcare
information that deCODE is collecting using the homogeneous Icelandic population
(the "Icelandic Healthcare Database" or "IHD") and a database based on genotypic
information that deCODE intends to collect (the "deCODE Genotype Database" and
collectively with the IHD, the "deCODE Database"). Institutions are creating a
database based on the phenotypic and genotypic information that Institutions are
collecting in connection with internal research using various heterogeneous
populations ("Research Patient Data Registry" or "RPDR") (the deCODE Database
and the RPDR are individually referred to as a "Database" and collectively
referred to as the "Databases").
B. Institutions and deCODE believe that by jointly performing an
ongoing series of research programs, they can speed the discovery, development
and commercialization of innovative health care products, and further the
research, teaching, education, and public service goals of Institutions.
C. There are three primary objectives of the Alliance: 1) to enable
Institutions' investigators to conduct research sponsored by deCODE as
determined by the JSC (as herein defined), pursuant to sponsored research
agreements to be entered into from time to time (the "Sponsored Research
Agreements"); 2) to create an information technology bridge to facilitate
studies with the deCODE Database and the RPDR pursuant to the Crosswalk
Development Agreement; and 3) to develop new information technology products and
services relating to the use of the Crosswalk for future pharmaceutical and
biotechnology applications.
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D. In addition, Institutions and deCODE envision that the Alliance
shall encompass a wide range and growing number of interactions. More
specifically, Institutions and deCODE wish to provide for, among other matters,
sponsored and other forms of collaborative research which may include the
enhancement of the Databases, the creation of an information technology bridging
structure, the Crosswalk, to facilitate studies with both the RPDR and the
deCODE Database, the establishment of standard operating procedures for querying
the Databases via the Crosswalk while preserving patients' confidential
information, the further development and commercialization by deCODE of
inventions made during the course of such research or other activities under the
Alliance by Institutions and its investigators, the licensing of technology from
Institutions to deCODE, Institutions' licenses to certain of deCODE's
proprietary processes and other technologies, and possible additional
initiatives.
E. This Agreement is intended to establish a framework in which the
Alliance shall operate and develop.
Institutions and deCODE have, therefore, agreed as follows:
1. Definitions.
1.1 "Alliance" shall have the meaning assigned to such term in the
Introductory paragraph.
1.2 "BWH" shall have the meaning assigned to such term in the
Introductory paragraph.
1.3 "Clinical Trial Agreement" shall have the meaning assigned to such
term in Section 2.5.2(c).
1.4 "Confidential Information" of a Party shall mean (a) all technical
or marketing reports, data or information disclosed by such Party to the other
Party which is in writing and marked or otherwise designated in writing as
"Confidential" or "Proprietary," (b) if disclosed orally, is indicated as
confidential at the time of disclosure summarized in writing and marked or
otherwise designated in writing as "Confidential" or "Proprietary" within thirty
(30) days after such disclosure, (c) all source code or object code.
1.5 "Crosswalk" shall have the meaning assigned to such term in the
Crosswalk Development Agreement.
1.6 "Crosswalk Coordinator" shall have the meaning assigned to such
term in the Crosswalk Development Agreement.
1.7 "Crosswalk Copyrightable Works" shall have the meaning assigned to
such term in the Crosswalk Development Agreement.
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1.8 "Crosswalk Development Period" shall have the meaning assigned to
such term in the Crosswalk Development Agreement.
1.9 "Crosswalk Information" shall have the meaning assigned to such
term in the Crosswalk Development Agreement.
1.10 "Crosswalk Intellectual Property Rights" shall have the meaning
assigned to such term in the Crosswalk Development Agreement.
1.11 "Crosswalk Inventions" shall have the meaning assigned to such
term in the Crosswalk Development Agreement.
1.12 "Crosswalk Project" shall have the meaning assigned to such term
in the Crosswalk Development Agreement.
1.13 "Database Facilitator" shall have the meaning assigned to such
term in Section 4.3.2.
1.14 "Databases" shall have the meaning assigned to such term in the
Background section.
1.15 "deCODE" shall have the meaning assigned to such term in the
Introductory paragraph.
1.16 "deCODE Database" shall have the meaning assigned to such term in
the Background section.
1.17 "deCODE Genotype Database" shall have the meaning assigned to such
term in the Background section.
1.18 "deCODE's Indemnitees" shall have the meaning assigned to such
term in Section 12.1.2.
1.19 "deCODE Materials" shall have the meaning assigned to such term in
any Sponsored Research Agreement under which such deCODE Materials are provided
by deCODE.
1.20 "deCODE Notice" shall have the meaning assigned to such term in
Section 10.5.
1.21 "Effective Date" shall have the meaning assigned to such term in
the Introductory paragraph.
1.22 "Embedded Technology" shall have the meaning assigned to such term
in the Crosswalk Development Agreement.
1.23 "Executive Officers" shall have the meaning assigned to such term
in Section 2.4.2.
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1.24 "Icelandic Healthcare Database" or "IHD" shall have the meaning
assigned to such term in the Background section.
1.25 "Institution" and "Institutions" shall have the meanings assigned
to such terms in the Introductory paragraph.
1.26 "Institution Crosswalk Information" shall have the meaning
assigned to such term in the Crosswalk Development Agreement.
1.27 "Institutions' Indemnitees" shall have the meaning assigned to
such term in Section 12.1.1.
1.28 "Institution Materials" shall have the meaning assigned to such
term in any Sponsored Research Agreement under which such Institution Materials
are provided by any Institution.
1.29 "Institution Notice" shall have the meaning assigned to such term
in Section 10.5.
1.30 "Institution Research Data" shall have the meaning assigned to
such term in the Sponsored Research Agreement.
1.31 "IP Project Leader" shall have the meaning assigned to such term
in Section 4.7.
1.32 "JAMS" shall have the meaning assigned to such term in Section
13.2.
1.33 "JSC" shall have the meaning assigned to such term in Section 2.1.
1.34 "MGH" shall have the meaning assigned to such term in the
Introductory paragraph.
1.35 "Other Technology" shall mean the design, technical description
and software (including programs, modules, code, algorithms, flowcharts,
diagrams, documentation and the like) developed by a Party outside the scope of
the Crosswalk Development Agreement, whether before or during the Crosswalk
Development Period, which is used to facilitate studies from, a Party's database
(e.g., genotypic or phenotypic database infrastructure, a query tool), and which
a Party licenses to the other Party pursuant to a Software License Agreement
entered into by the Parties as provided in Section 4.5.
1.36 "Party" and "Parties" shall have the meanings assigned to such
terms in the Introductory paragraph.
1.37 "Partners" shall have the meaning assigned to such term in the
Introductory paragraph.
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1.38 "Research Patient Data Registry" of "RPDR" shall have the meaning
assigned to such term in the Background section.
1.39 "Software License Agreement" shall have the meaning assigned to
such term in Section 4.5.
1.40 "Sponsored Research Agreement" shall have the meaning assigned to
such term in Section 2.5.2(c).
1.41 "Term" shall have the meaning assigned to such term in Section
10.1.
1.42 "Work Plan" shall have the meaning assigned to such term in the
Crosswalk Development Agreement or Sponsored Research Agreement, as the case may
be.
2. Joint Steering Committee.
2.1 Composition. A Joint Steering Committee (the "JSC") shall
coordinate the interactions between Institutions and deCODE provided for by this
Agreement. The JSC shall consist of four representatives of each of Institutions
and deCODE. Members of the JSC shall be appointed from time to time by the
respective Executive Officers of Institutions and deCODE and shall serve at the
pleasure of the officer who appoints them. If either Party changes its
representatives on the JSC, it shall provide prompt written notice to the other
Party of such change. Members of the JSC shall include individuals within the
senior management, and in the case of Institutions also faculty, of each Party.
Each Party may, upon the consent of both Parties, invite non-member
representatives of such Party to attend meetings of the JSC, as such Party deems
appropriate.
2.2 Officers. The chairperson and secretary of the JSC shall serve
co-terminous one (1)-year terms, each commencing on the Effective Date or an
anniversary thereof, as the case may be. The right to name the chairperson and
the secretary of the JSC shall alternate between the Parties, and each
chairperson and secretary shall be named no later than ten (10) days after the
commencement of his or her term. The initial chairperson shall be selected by
deCODE and the initial secretary shall be selected by Institutions. The
chairperson shall, if practicable, send written notice of all meetings to all
members of the JSC no less than ten (10) days before the date of each meeting.
2.3 Meetings. During the term of this Agreement, the JSC shall meet in
person at least once during every calendar quarter, and more frequently as the
Parties deem appropriate, on such dates, and at such places and times, as the
Parties shall agree. Meetings of the JSC that are held in person shall alternate
between the offices of the Parties, or such other place as the Parties may
agree. The members of the JSC also may convene or be polled or consulted from
time to time by means of telecommunications, videoconferences, electronic mail
or correspondence, as deemed necessary or appropriate.
2.4 Vote Required for JSC to Act.
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2.4.1 The JSC shall act only by favorable vote of both (a) a
majority of the representatives of deCODE present at any meeting of the JSC at
which an action is to be taken, and (b) a majority of the representatives of
Institutions present at such meeting; provided, however, no action shall be
taken at any such meeting unless at least two representatives of each Party
(including for this purpose any proxy representative appointed as provided
below) are present at the meeting. Attendance at any meeting of the JSC may be
by telephone or videoconference, or by other similar electronic means. If a
member of the JSC is unable to attend a meeting, he or she may appoint, in
writing, a proxy to participate and vote in his or her stead.
2.4.2 If, with respect to a matter that is subject to the
JSC's decision-making authority (and except as otherwise provided in Section
2.4.3), the JSC cannot reach consensus within fifteen (15) days after it has met
and attempted to reach such consensus, the matter shall be referred on the
sixteenth (16th) day to the Chief Executive Officer of deCODE, or such other
similar position designated by deCODE from time to time, and the Chief Executive
Officer of Partners, or such other similar position designated by Institutions
from time to time (such officers, collectively, the "Executive Officers"), for
resolution. The Executive Officers shall use reasonable efforts to resolve the
matter referred to them. If the Executive Officers cannot reach a mutually
acceptable decision within fifteen (15) days after the matter was referred to
them, then the Parties shall submit such matter to arbitration in accordance
with Section 13.2. THE FOREGOING REMEDY SHALL BE EACH PARTY'S SOLE AND EXCLUSIVE
REMEDY WITH RESPECT TO ANY SUCH DISPUTE.
2.4.3 If the JSC receives a deCODE Notice or an Institution
Notice pursuant to Section 10.5, the JSC shall have a meeting as soon as
practicable thereafter, and in any event not more than ten (10) days after
receipt of such deCODE Notice or Institution Notice. If the JSC cannot reach
consensus within ten (10) days after it has met and attempted to reach such
consensus, the matter shall be referred on the eleventh (11th) day to the
Executive Officers for resolution. The Executive Officers shall use reasonable
efforts to resolve the matter referred to them. If the Executive Officers cannot
reach a mutually acceptable decision within ten (10) days after the matter was
referred to them, then deCODE shall send a notice of termination as required in
Section 10.5.
2.4.4 In no event shall the decision-maker under this Section
2.4 (including any arbitration panel) have the final authority to make any
decision that: (a) would be inconsistent with any of the laws, rules and
regulations pertaining to the use of either of the Databases, including: (1) in
the case of the IHD, the operating license granted to deCODE by the Icelandic
Ministry of Health and Social Security, the agreement dated January 21, 2000
between the Icelandic Minister of Health and Social Security and deCODE
concerning such operating license and the Icelandic Act on a Health Sector
Database No. 139/1998 as same may be amended from time to time, and (2) in the
case of the RPDR, the laws, rules and regulations of Massachusetts and the
United States government or any agency thereof and the policies of Institutions,
including without limitation the decisions of the Institutional Review Boards of
Partners, MGH or BWH; (b) would compromise patients' confidential information or
disclose Confidential Information to any third party; or (c) would be
inconsistent with the research, teaching, education and public
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service mission of Institutions, as reasonably determined by Institutions.
2.4.5 For all purposes under this Agreement, any decision made
pursuant to Section 2.4.2 or Section 2.4.3 shall be deemed to be the decision of
the JSC.
2.5 Responsibilities of the JSC.
2.5.1 The JSC shall be responsible for directing the future
development of the Alliance, and shall explore new areas of possible cooperation
between Institutions and deCODE.
2.5.2 In connection with research sponsored by deCODE at any
Institution under a Sponsored Research Agreement or a Clinical Trial Agreement,
as applicable, the JSC shall:
(a) Review the research proposals submitted by deCODE
or any Institution, including the Work Plan and budget responding to such
research proposal prepared by such Institution, provided that such proposals are
consistent with deCODE's internal needs and strategies, and select those
research proposals that shall be funded in whole or in part with the funds
provided under Section 3.2; provided that neither Party shall be required to
participate in a proposed research project without such Party's consent;
(b) Use an accelerated review process, as determined
by the Parties, to review all such research proposals, including the final work
proposal and budget therefor, and, on the basis of such review process, select
those research proposals which shall be conducted by an Institution and funded
with the funds provided under Section 3.2.
(c) Review and approve the terms of each Sponsored
Research Agreement, which shall be substantially in the form attached hereto as
Appendix A (each, a "Sponsored Research Agreement"), and each Clinical Trial
Agreement, which shall be substantially in the form attached hereto as Appendix
B (each, a "Clinical Trial Agreement"), as applicable, which shall be negotiated
by the Parties for each research proposal and budget selected by the JSC
pursuant to Section 2.5.2(a);
(d) Oversee all research projects selected by the JSC
pursuant to Section 2.5.2(a), (b) and (c), using as oversight criteria the
research policies of the Institution in which the research is conducted and the
research policies of deCODE, and using periodic informational status reports and
updates concerning the sponsored research provided by the Principal Investigator
and the deCODE Representative (as such terms are defined in the relevant
Sponsored Research Agreements or the Clinical Trial Agreements, as the case may
be);
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(e) Determine royalty rates, milestone dates,
milestone payments and/or annual minimum payments for any License Agreement (as
defined in the Sponsored Research Agreement or the Clinical Trial Agreement, as
applicable) to be entered into between deCODE and an Institution pursuant to any
Sponsored Research Agreement or Clinical Trial Agreement, as the case may be, as
provided in such Sponsored Research Agreement or such Clinical Trial Agreement;
and
(f) Resolve any disputes between deCODE and any
Institution arising under or in connection with any Sponsored Research Agreement
or Clinical Trial Agreement.
2.5.3 In connection with the development of the Crosswalk, and
the development, marketing and sales of products and services therefrom, the JSC
shall:
(a) Review and approve the Work Plan and budget for
the Crosswalk Project to be conducted pursuant to the Crosswalk Development
Agreement, ensuring that such Work Plan includes the cost accounting methods by
which costs shall be incurred, a recitation of the allocation of funds for
project operating and maintenance costs, the source of funds to be used in
connection with project costs (including personnel resource contributions from
Institutions for operation and maintenance costs), and a work schedule
specifying task commencement and completion dates, all as contemplated by the
Crosswalk Development Agreement.
(b) Oversee the Crosswalk Project, based on periodic
reports from the Crosswalk Coordinators appointed by each of the Parties
pursuant to the Crosswalk Development Agreement;
(c) Establish the commercial terms, including service
fees, for use of the Crosswalk, including use of all query tools, other
information technology tools and infrastructure software, which are components
of the Crosswalk and are used to facilitate studies with the RPDR or both
Databases;
(d) Review and establish standard operating
procedures for the facilitation of studies with the Databases via the Crosswalk.
Such standard operating procedures shall prevent disclosure to third parties of
Confidential Information of the Parties and patients' confidential information
and shall be in compliance with: (i) each Party's internal operating procedures
regarding such Party's Database, and (ii) all laws, rules and regulations
applicable to such Database, including: (1) in the case of the IHD, the
operating license granted to deCODE by the Icelandic Ministry of Health and
Social Security, the agreement dated January 21, 2000 between the Icelandic
Minister of Health and Social Security and deCODE concerning such operating
license and the Icelandic Act on a Health Sector Database No. 139/1998 as same
may be amended from time to time, and (2) in the case of the RPDR, the laws,
rules and regulations of Massachusetts and the United States government or any
agency thereof and the policies of Institutions, including without limitation
the decisions of the Institutional Review Boards of Partners, MGH or BWH.
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(e) Monitor compliance with all laws with respect to
the use of the Crosswalk;
(f) Establish criteria for determining the royalty
rate(s) (1) to be paid by deCODE to Institutions based on the revenues obtained
from the products and services related to the Crosswalk, and (2) to be paid by
Institutions to deCODE for revenues obtained from Institutions' use of the
Crosswalk, or any components of the Crosswalk, pursuant to Section 4.3.1(c),
until such time as the Parties discontinue marketing and sales of such products
and services, or as determined by the Parties, such products and services have
no commercial value; in each case such royalty rate(s) to be based on the
customary standards in agreements between academia and industry for joint
development of the Crosswalk, including the Crosswalk Intellectual Property
Rights to be licensed, which take into account: (i) the type of product or
services which shall be developed using such Crosswalk; (ii) the amount of
resources (in the form of financial, in kind technology, personnel, and the
like) contributed by each Party to the development of the Crosswalk; (iii) the
degree to which the license is for a Crosswalk Invention or Crosswalk
Copyrightable Work owned solely by Institution, solely by deCODE or jointly by
both Parties; (iv) the extent of the development required to create a
commercializable product or service; (v) potential sales volume and
profitability of the products or services; and (vi) projected expenses to
develop and market the products or services.
(g) Resolve any disputes between the Crosswalk
Coordinators and/or IP Project Leaders of the Parties arising under or in
connection with the Crosswalk Development Agreement and this Agreement; and
(h) Resolve any disputes between deCODE and any
Institution arising under or in connection with the Crosswalk Development
Agreement and this Agreement.
2.6 Minutes of Meetings.
2.6.1 With the sole exception of specific items of the meeting
minutes to which the chairperson and the secretary cannot agree and which are
escalated as provided in Section 2.4.2, definitive minutes of all JSC meetings
shall be finalized no later than thirty (30) days after the meeting to which the
minutes pertain, as follows:
(a) Within ten (10) days after each JSC meeting, the
secretary shall prepare and distribute to all members of the JSC draft minutes
of the meeting. Such minutes shall provide a description, in reasonable detail,
of the discussions at the meeting and a list of any actions, decisions or
determinations approved by the JSC and a list of any issues to be resolved by
the Executive Officers.
(b) The chairperson shall then have ten (10) days
after receiving such draft minutes to collect comments thereon from the members
of its Party and provide them to the secretary.
(c) Upon the expiration of such second ten (10) day
period, the
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chairperson and the secretary of the JSC shall have an additional ten (10) days
to discuss each other's comments and finalize the minutes. The secretary and
chairperson shall each sign and date the final minutes. The signature of the
chairperson and the secretary upon the final minutes shall indicate each Party's
assent to the minutes.
2.6.2 If at any time during the preparation and finalization
of the JSC meeting minutes, the secretary and the chairperson do not agree on
any issue with respect to the minutes, such issue shall be resolved by the
escalation process as provided in Section 2.4.2. The decision resulting from the
escalation process shall be recorded by the secretary in amended finalized
minutes for said meeting. All other issues in the minutes that are not subject
to such escalation shall be finalized within a thirty (30)-day period as
provided in Section 2.6.1.
2.6.3 Each Party shall be responsible for all travel and
related costs and expenses for its members and approved invitees to attend
meetings of, and otherwise participate on, the JSC.
3. Sponsored Research and Clinical Trial Agreements.
3.1 Research Projects. Beginning on the Effective Date and continuing
thereafter for the next three (3) years, unless sooner terminated:
3.1.1 deCODE and Institutions shall prepare and submit
research proposals to the other, through the JSC, from time to time for proposed
research or clinical studies. In preparing such proposals, the Parties shall
implement scientist-to-scientist communications between deCODE and Institutions
and shall consider the position of the other Party. The Parties currently
anticipate that the Parties shall submit approximately [CONFIDENTIAL TREATMENT
REQUESTED] research proposals each year, and that these proposals may be for
studies which involve [CONFIDENTIAL TREATMENT REQUESTED]. To the extent that the
Parties expand the proposals (e.g., [CONFIDENTIAL TREATMENT REQUESTED]), the
Parties acknowledge and agree that the terms of a Sponsored Research Agreement
may need to be modified to address the additional issues raised by such
development;
3.1.2 Any Institution may submit a draft work proposal and
budget in response to any such research proposal for review and discussion with
deCODE, through the JSC.
3.1.3 The JSC shall review all such research proposals,
including the final work proposal and budget therefor, as provided in Section
2.5.2, and shall, on the basis of such review process, select those research
proposals which shall be conducted by an Institution and funded with the funds
provided under Section 3.2.
3.1.4 Subject to Section 2.5.2 of this Agreement, upon
selection of a research proposal by the JSC, deCODE and the Institution that
submitted the work proposal and budget therefor shall enter into negotiations to
reach a mutually acceptable Sponsored Research Agreement or Clinical Trial
Agreement, as applicable, which, if completed, shall govern all rights and
obligations of the parties with respect to such research proposal and any
results or inventions
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therefrom.
3.1.5 The parties may, by mutual agreement and upon written
consent of the JSC, modify the Sponsored Research Agreement or the Clinical
Trial Agreement, as applicable, as the Parties deem necessary or desirable to
allow for specific work performed as a result or in furtherance of the sponsored
research or clinical study.
3.1.6 Nothing in this Section 3.1 shall be deemed to require
deCODE to submit any particular research proposal to any Institution, or to
require any Institution to submit a work proposal and budget for any such
research proposal, or to require either Party to enter into any Sponsored
Research Agreement or any Clinical Trial Agreement.
3.2 Funding. In consideration of the undertaking by Institutions,
deCODE shall provide a total of up to [CONFIDENTIAL TREATMENT REQUESTED] of
research funding to support the research proposals selected by the JSC for which
a Sponsored Research Agreement or a Clinical Trial Agreement is entered into.
4. Crosswalk Project.
4.1 Work Plan. Under the direction and oversight of the JSC as
set forth in this Agreement:
4.1.1 Simultaneously with the execution of this Agreement,
deCODE and Institutions shall enter into the Crosswalk Development Agreement
attached hereto as Appendix C (the "Crosswalk Development Agreement"). An
outline of the format and strategy to be employed by the Alliance in the
development of the Crosswalk shall be attached thereto, and shall include the
development of an information technology bridge to facilitate studies with the
Databases by a number of means including the creation of common definitions of
disease classifications, common structure and field compatibility of the
Databases and the creation of tools to query those Databases.
4.1.2 The final Work Plan and budget shall be agreed upon by
the JSC, as provided in Section 2.5.3, and attached to the Crosswalk Development
Agreement.
4.2 Funding. Following the execution of the Crosswalk Development
Agreement, deCODE shall provide funding to Institutions, and Institutions shall
provide project operation and maintenance contributions, as set forth in the
Crosswalk Development Agreement.
4.3 Use of Crosswalk.
4.3.1 From the Effective Date and during the period that the
Parties are paying royalties on the sales of products and services using the
Crosswalk:
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(a) Each of deCODE and Institutions shall have the
co-exclusive right (solely with the other Party) to use the Crosswalk to
facilitate studies with the Databases for non-commercial internal research,
education and patient care purposes, including research for any state or federal
agency, private or public foundation, except foundations owned or operated by a
commercial entity other than deCODE, but not for commercially sponsored research
or for private or public foundations which have contractual obligations to
commercial entities with respect to such research or any other commercial
applications, and for such other similar purposes that the JSC determines is
appropriate, from time to time; and
(b) deCODE shall have the exclusive right to use the
Crosswalk, or any component parts of the Crosswalk, to facilitate studies with
the deCODE Database for commercially sponsored research for the benefit of any
commercial third party or for private or public foundations or any third party
which have contractual obligations to a commercial third party related to such
Crosswalk use, without any obligation to Institutions with respect to such use;
and
(c) Institutions shall have the exclusive right to
use the Crosswalk, or any component parts of the Crosswalk, to facilitate
studies with the RPDR for commercially sponsored research for the benefit of any
commercial third party or for private or public foundations or any third party
which have contractual obligations to a commercial third party related to such
Crosswalk use, according to the commercial terms established by the JSC pursuant
to Section 2.5.3(c) and subject to the royalty obligation established by the JSC
therefor pursuant to Section 2.5.3(f);
(d) deCODE shall have the exclusive right to use the
Crosswalk for all other purposes in connection with the development and
marketing of products and services using the Crosswalk pursuant to Section 4.6,
including the right to sublicense the use of the Crosswalk, if necessary, in
connection therewith, pursuant to the terms and conditions set forth in this
Agreement, according to the commercial terms established by the JSC pursuant to
Section 2.5.3(c) and subject to the royalty obligation established by the JSC
therefor pursuant to Section 2.5.3(f); and
(e) All use of the Crosswalk pursuant to this Section
4.3.1 shall be in compliance with all standard operating procedures established
for such Database pursuant to Section 2.5.3(d) and as provided in Section 4.3.2.
(f) Notwithstanding anything in this Section 4.3.1 to
the contrary, each Party shall have the right to use any Embedded Technology
contributed by such Party for use in the Crosswalk to facilitate studies with
such Party's own Database for any purpose without obligation to the other
Parties. Therefore, if a Party contributed Embedded Technology for use in the
Crosswalk, and uses such Embedded Technology to facilitate studies with such
Party's own Database but otherwise does not use any component of the Crosswalk,
such Party shall have no obligation to the other Parties with respect to such
use.
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4.3.2 All requests for the facilitation of studies with the
other Party's Database by either Party, whether for internal research purposes
pursuant to Section 4.3.1(a) or for commercial use pursuant to Section 4.3.1(d),
shall be made by the requesting Party to a designated representative of the
other Party (such other Party's representative, its "Database Facilitator"). The
Database Facilitator for each Party shall be responsible for conducting all such
requests and for coordinating the involvement of any other representatives of
such Party or of any governmental agency necessary to be involved in such
request, pursuant to such Party's internal process and procedures for such
queries and facilitation. Each Party hereby agrees to comply with such
procedures and cooperate with the other Party's Database Facilitator to process
such request for study facilitation in compliance with all standard operating
procedures established by the JSC and applicable to such Party's Database. Each
Party's Database Facilitator may prohibit a request to facilitate a study with
such Party's Database if such request is not consistent with such standard
operating procedures.
4.3.3 Nothing in Section 4.3.1 shall prohibit either Party
from using any software or other intellectual property, including query tools
and information technology tools (other than another Party's Other Technology
licensed as provided in Section 4.5) developed, owned, controlled and developed
outside the scope of the Crosswalk Project by such Party and not contributed by
such Party to the Crosswalk Project to facilitate studies with such Party's own
Database for any purpose without obligation, financial or otherwise, to the
other Party.
4.3.4 Nothing in this Section 4.3 shall permit either Party to
disclose any data contained in the other Party's Database at any time without
compliance with Section 6 or such other Party's prior written consent.
4.4 License Grants for Use of Crosswalk.
4.4.1 To enable the use of the Crosswalk by deCODE as
contemplated by Section 4.3.1, Institutions hereby grant deCODE, subject to the
terms and conditions of this Agreement:
(a) The co-exclusive (with Institutions with respect
to the rights specifically reserved by Institutions by Section 4.3.1 and 4.4.2),
worldwide right and license under Institutions' rights in and to the Crosswalk
Intellectual Property Rights (including the right and license to use, copy,
distribute and sublicense the Crosswalk Copyrightable Works, including "joint
works" or jointly-owned works as determined under the United States Copyright
Laws or the laws of any foreign jurisdiction, in any country without the consent
of Institutions and without the duty to account to Institutions for any profits
or royalties on account of such use, copying, distribution or sublicensing
except as otherwise provided in this Agreement), to develop, make, have made,
use, import, export, lease, offer to sell, sell, have sold and otherwise exploit
products and services using the Crosswalk for the purposes provided in Section
4.3.1 according to the commercial terms established by the JSC pursuant to
Section 2.5.3; and
(b) The non-exclusive license to use the Institution
Crosswalk Information, and Institution Research Data not exclusively licensed to
deCODE by the License
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Agreements entered into pursuant to any Sponsored Research Agreement, to
develop, make, have made, use, import, export, lease, offer to sell, sell, have
sold and otherwise exploit products and services using the Crosswalk for the
purposes provided in Section 4.3.1 according to the commercial terms established
by the JSC pursuant to Section 2.5.3; and
(c) The right to grant sublicenses with respect to
the rights and licenses granted under this Section 4.4.1 to third parties;
provided, however, that the right to use any Crosswalk Intellectual Property
Rights covering any Embedded Technology contributed to the Crosswalk by
Institutions shall be a non-exclusive right and license.
4.4.2 To enable the use of the Crosswalk by Institutions as
contemplated by Section 4.3.1, it is understood that the granting of the
licenses in Section 4.4.1 is subject to the right of Institutions to make and
use such Crosswalk Intellectual Property Rights, Institution Crosswalk
Information and Institution Research Data for the purposes provided in Section
4.3.1, and that if federal funding supported such Crosswalk Intellectual
Property Rights, deCODE's license shall be subject to the rights, conditions and
limitations imposed by U.S. law including without limitation the royalty-free
non-exclusive license granted to the U.S. government (see 35 U.S.C. Section 202
et seq. and regulations pertaining thereto).
4.4.3 To enable the use of the Crosswalk by Institutions as
contemplated by Section 4.3.1, deCODE hereby grants to Institutions, a
co-exclusive (with deCODE with respect to the rights specifically reserved by
deCODE by Section 4.3.1), worldwide right and license under deCODE's rights in
and to the Crosswalk Intellectual Property Rights (including the right and
license to use, copy, distribute and sublicense the Crosswalk Copyrightable
Works, including "joint works" or jointly-owned works as determined under the
United States Copyright Laws or the laws of any foreign jurisdiction, in any
country without the consent of Institutions and without the duty to account to
Institutions for any profits or royalties on account of such use, copying,
distribution or sublicensing except as otherwise provided in this Agreement), to
develop, make, have made, use, import, export, lease, offer to sell, sell, have
sold and otherwise exploit products and services using the Crosswalk for the
purposes provided in Section 4.3.1 according to the commercial terms established
by the JSC pursuant to Section 2.5.3; provided, however, that the right to use
any Crosswalk Intellectual Property Rights covering any Embedded Technology
contributed to the Crosswalk by deCODE shall be a non-exclusive right and
license.
4.5 Use of Other Technology. The Parties contemplate that they will
enter into a software license agreement for Institutions to acquire a license to
certain Other Technology the first such license attached hereto as Appendix E
shall pertain to a software product of deCODE that manages work flow for genetic
studies. Additional software license agreements, if any, shall be substantially
in the form of the software license agreement attached hereto as Appendix E. In
addition, each Party shall have the right, but not the obligation, to permit the
other Party to use such of such Party's Other Technology as the Parties may
agree upon from time to time, subject to Section 4.3 and pursuant to the terms
of software license agreements to be entered into between the Parties to license
such Other Technology, which shall be on terms and conditions as
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the Parties may agree. All software license agreements entered into with respect
to any Other Technology under this Agreement shall be a "Software License
Agreement."
4.6 Product Development and Marketing. deCODE shall be responsible for
all product development and marketing of products and services using the
Crosswalk, as described in Section 4.3.1(d), at deCODE's sole expense.
Institutions shall appoint a marketing and development representative from
Institutions, at Institutions' sole expense, who shall: (a) provide a
communication contact between deCODE and Institutions; and (b) have the
day-to-day responsibility for overseeing and coordinating, on behalf of
Institutions, the marketing and development activities being conducted by deCODE
as contemplated herein. deCODE shall present a marketing plan to the JSC
periodically for the JSC's review and comment.
4.7 Intellectual Property Protection. The Institutions and deCODE shall
each appoint a representative (such Party's "IP Project Leader") to: (a) develop
strategies for the protection of the Crosswalk Intellectual Property Rights; (b)
provide a communication contact between Institutions and deCODE to discuss
intellectual property protection issues, review, comment and/or approve filings,
responses, actions or the like with respect to Crosswalk Intellectual Property
Rights matters; and (c) have the day-to-day responsibility for overseeing and
coordinating protection of the Crosswalk Inventions, Crosswalk Copyrightable
Works and the marketing and development activities on behalf of Institutions
contemplated in this Agreement. Each Party's IP Project Leader shall be
responsible for coordinating input on intellectual property matters from such
Party's patent counsel and such other representatives of such Party as are
necessary to finalize decisions regarding such matters. The IP Project Leaders
shall submit periodic reports regarding the status and plans for intellectual
property protection to the JSC for its review and comment, and the IP Project
Leaders shall comply with the strategy directives from the JSC concerning such
intellectual property matters.
5. Ownership of Data and Intellectual Property.
5.1 Institutions Ownership. Institutions shall retain all right, title
and interest in the RPDR and any data contained therein, and shall have the
right to use the RPDR without any obligation to deCODE.
5.2 deCODE Ownership. deCODE shall retain all right, title and interest
in the deCODE Database and any data contained therein, and shall have the right
to use the deCODE Database without any obligation to Institutions.
5.3 Specific Agreements. The rights of each Party with respect to the
ownership of inventions and data arising under any Sponsored Research Agreement
or under the Crosswalk Development Agreement shall be governed by the terms of
the applicable Sponsored Research Agreement or the Crosswalk Development
Agreement. deCODE's right to commercialize any such invention or work of
authorship shall be determined by the license terms of the Crosswalk Development
Agreement, this Agreement, any Sponsored Research Agreement and any License
Agreement entered into as a result thereof. The rights of each Party with
respect to any Other Technology shall be governed by the terms of the applicable
Software License Agreement.
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6. Publications.
The publication of any data or information arising from or developed in
the performance of the Sponsored Research Agreements, or any License Agreements
resulting therefrom, or the Crosswalk Development Agreement shall be governed by
the relevant terms and conditions of such agreements as such agreements relate
to publication.
7. Expanded Relationship.
7.1 Expanding Alliance. Prior to January 1, 2002, the Parties shall
meet to determine if they want to expand this Alliance to:
7.1.1 [CONFIDENTIAL TREATMENT REQUESTED]; and/or
7.1.2 [CONFIDENTIAL TREATMENT REQUESTED].
7.2 Right of First Offer. In the event that the Parties do not
negotiate an agreement to accomplish the goals set forth in Sections 7.1.1 or
7.1.2, then deCODE shall have a right of first offer to enter into an agreement
therefor, as follows:
7.2.1 At any time during the Term of this Agreement,
Institutions, or any one of them, are interested in entering into such an
agreement with a third party, Institutions shall give written notice thereof to
deCODE, together with any and all relevant information regarding such
arrangement that Institutions have in their possession or control, and including
a summary term sheet of the material terms and conditions of such arrangement.
deCODE shall have thirty (30) days after receipt of such written notice and all
such information and data to decide whether or not it is interested in entering
into such an agreement with Institutions, or any one of them.
7.2.2 If deCODE notifies Institutions in writing within such
thirty (30)-day period that it is interested in entering into such an agreement,
then the Parties shall promptly commence good faith negotiations, for a period
of up to one hundred twenty (120) days after deCODE provides such notice to
Institutions, in an effort to reach mutually acceptable definitive agreements.
During such one hundred twenty (120)-day period, Institutions shall not
negotiate or discuss such an arrangement with any third party. If, despite each
Party's good faith efforts, Institutions, or any one of them., and deCODE are
not able reach definitive agreements within such one hundred twenty (120)-day
period, then Institutions shall be free to negotiate with any third party for
such arrangement without further obligation to deCODE.
7.3 Other Expansion. In the event either Party desires to expand the
Alliance other than as described in Section 7.1, such Party shall submit a
proposal of such expansion to the other Party for consideration. If the other
Party is interested in discussing such expansion, then each Party shall
negotiate in good faith, on a non-exclusive basis, to establish mutually
agreeable terms on which to expand the Alliance.
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8. Confidential Information.
8.1 Duty of Nondisclosure. Except as otherwise provided in Section 8.2,
during the term of this Agreement and for a period of ten (10) years thereafter,
each Party agrees to use reasonable efforts not to disclose to third parties any
Confidential Information disclosed to it by the other Party.
8.2 Scope. Nothing in this Agreement shall limit any Party in any way
from: (a) disclosure of information required by a public authority; or (b)
disclosure of information that is necessary to prevent imminent danger to the
public; provided, however, in each case the disclosing Party shall promptly
inform the other Party of its intent to disclose such information and the
reasons for such disclosure.
8.3 Exceptions. Information received from the other Party hereto shall
not be deemed Confidential Information, and the receiving Party shall have no
obligation of confidentiality with respect to such information which:
8.3.1 As of the Effective Date, is part of the public domain;
8.3.2 Subsequently becomes part of the public domain through
no fault of the receiving Party;
8.3.3 The receiving Party can show was in its possession, as
evidenced by written records kept in the ordinary course of business or by the
proof of actual use at the time of executing this Agreement, and which
information had not been wrongfully acquired, directly or indirectly, from the
disclosing Party;
8.3.4 Is subsequently disclosed to the receiving Party by a
third party not in violation of any right of, or obligation to, the other Party
hereto;
8.3.5 Is required to be disclosed by operation of law,
provided that the receiving Party has given advanced notice of the proposed
disclosure to the disclosing Party, or
8.3.6 Is developed by or on behalf of the receiving Party
without reference to the disclosing Party's Confidential Information, as
evidenced by written records.
8.4 Injunctive Relief. In addition to any other right or remedy it may
have and without the posting of any bond or other security, each Party shall be
entitled to seek injunctions to enjoin or restrain the other Party from any
violation or threatened violation of this Section 8.
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9. Publicity and Advertising.
No Party shall, without the prior written consent of the other Party,
use in endorsement, advertising, publicity, or otherwise, the name, trademark,
logo, symbol, or other image of the other Party or such Party's employees or
agents. Each Party shall permit its name to be used: (a) whenever required by
law or regulation, including without limitation disclosure to the Securities and
Exchange Commission, provided, however, that a Party using another Party's name
shall, to the extent reasonably practicable as solely determined by such using
Party, provide a copy of such proposed disclosure to such other Party in advance
and give consideration to such other Party's comments and requests regarding
such disclosure, but shall not be obligated to perform any act or omission in
response to such comments or requests; (b) by deCODE in connection with its
capital raising and financing purposes, based upon standard statements
established by the mutual agreement of the Parties; (c) to make a joint mutually
agreeable public announcement about the initiation of the Alliance, the support
of Research pursuant to Sponsored Research Agreements, and the development of
the Crosswalk pursuant to the Crosswalk Development Agreement, a copy of such
public announcement is attached as Appendix D; (d) to make routine
acknowledgments of the Alliance and the basic substance of the Alliance, based
upon standard statements established by the mutual agreement of the Parties. If
no such standard statements have been established, then the disclosing Party
shall provide the non-disclosing Party with an opportunity to review, comment on
and approve the disclosure in advance of making such disclosure; and (e) as
required under the terms of the Crosswalk Development Agreement, Sponsored
Research Agreement and Software License Agreement. Nothing in this Section 9
shall preclude deCODE's use of Institutions' names, trademarks, logos, symbols,
or other images in connection with the marketing and sale of products and
services pursuant to this Agreement, provided that any such use shall remain
subject to the approval of the Public Affairs Officer of the Institution whose
name, trademark, logo, symbol or other image is so used.
10. Term; Termination Provisions.
10.1 Term. The initial term of this Agreement shall be three (3) years,
provided that no later than three (3) months prior to the end of such three year
term, the Parties may mutually agree in writing to extend the term of this
Agreement for an additional two (2) year term (the initial period plus any
extension, the "Term"). At such time as the Parties may mutually agree to extend
the initial term of this Agreement, the Parties shall consider, in good faith,
the effect of termination of this Agreement during such extended period by
deCODE pursuant to Section 10.3 or termination of the Crosswalk Development
Agreement pursuant to Section 8.2 thereof during such extended period by deCODE.
Any writing providing for such extension shall also provide for the effect of
such termination events during such extension.
10.2 Breach by deCODE. If deCODE fails to meet any of its material
obligations under this Agreement and shall fail to remedy these failures within
sixty (60) days after receipt of written notice thereof, Institutions shall have
the option of terminating this Agreement upon written notice thereof; provided,
however, that deCODE shall have the right to cure such default during such sixty
(60) day period.
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10.3 Breach by Institutions. If any Institution fails to meet any of
its material obligations under this Agreement and shall fail to remedy these
failures within sixty (60) days after receipt of written notice thereof, deCODE
shall have the option of terminating this Agreement upon written notice thereof;
provided, however, that such Institution shall have the right to cure such
default during such sixty (60) day period.
10.4 Termination by deCODE for Infeasibility. In the event that deCODE
determines that the Alliance is scientifically or economically not feasible or
no longer is consistent with deCODE's business strategy, deCODE may terminate
this Agreement at any time during the Term by giving written notice of
termination to Institutions thirty (30) days prior to the effective date of such
termination.
10.5 Termination by deCODE for Other Reasons. In the event that either
deCODE or Institutions in good faith reasonably believe that the purposes of the
Alliance: (i) are materially inconsistent with any laws or regulations that
become effective after the Effective Date, or (ii) significantly jeopardize the
research, teaching, education and/or public service missions of Institutions; or
(iii) significantly jeopardize deCODE's status and position in the Icelandic or
international community in a manner not otherwise covered by Section 10.4, then
deCODE or Institutions, as the case may be, shall send notice of such belief to
the JSC (if deCODE sends such notice, a "deCODE Notice" and, if Institutions
send such notice, an "Institution Notice"). If the JSC or the Executive Officers
makes a determination, pursuant to the procedures set forth in Section 2.4, that
confirms such belief, or if agreement cannot be reach pursuant to Section 2.4.3,
then deCODE shall promptly terminate this Agreement by giving written notice of
termination to Institutions, and the effective date of such termination shall be
the date which is six months after the date of such determination pursuant to
Section 2.4.3. Such termination shall also be deemed to be notice of termination
of the Crosswalk Development Agreement pursuant to Section 8.4 thereof. In the
event of a termination of this Agreement by deCODE pursuant to this Section
10.5, at any time during such six month notice period, deCODE may, in its sole
discretion, terminate any or all Sponsored Research Agreements and Clinical
Trial Agreements that have been entered into on or before the date of notice of
such termination by giving Institutions ten (10) days' prior notice of such
termination(s). Upon notice of termination of this Agreement by deCODE, in
addition to the obligations provided in Section 8.5.1 or Section 8.5.4 of the
Crosswalk Development Agreement, as the case may be, during the six month
period, Institutions each Party shall cooperate with the other Party shall to
exchange or transfer to deCODE all knowledge, data, information and know-how
acquired by Institutions the Parties in connection with the performance of this
Agreement or the Crosswalk Development Agreement and shall cooperate with deCODE
to provide for an orderly transition of such knowledge, data, information and
know-how consistent with the rights of the Parties with respect to such
knowledge, data, information and know-how.
10.6 Effect of Termination on Funding Obligations.
10.6.1 In the event that this Agreement is terminated by
Institutions pursuant to Section 10.2, or by deCODE pursuant to Section 10.4 or
by deCODE pursuant to Section 10.5
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following a deCODE Notice, deCODE shall reimburse Institutions for contractual
commitments and financial obligations incurred under this Agreement by
Institutions during the Term if such financial obligations or contractual
commitments cannot reasonably be cancelled by Institutions; provided however,
that deCODE's obligations to reimburse for commitments and obligations incurred
under any agreements contemplated hereunder, such as the Crosswalk Development
Agreement, any Sponsored Research Agreements, Clinical Trial Agreements, License
Agreements or Software License Agreements, shall be governed solely by such
agreements. Institutions shall use their best efforts to terminate or cancel all
contractual commitments and other financial obligations as soon as possible to
avoid incurring additional expenses.
10.6.2 In the event that this Agreement is terminated by
deCODE pursuant to Section 10.3, all funding obligations of deCODE under this
Agreement shall cease as of the effective date of such termination; provided
however, that deCODE's obligations to reimburse for commitments and obligations
incurred under any agreements contemplated hereunder, such as the Crosswalk
Development Agreement, any Sponsored Research Agreements, Clinical Trial
Agreements, License Agreements or Software License Agreements, shall be governed
solely by such agreements.
10.6.3 In the event that this Agreement is terminated by
deCODE pursuant to Section 10.5 following an Institution Notice, all funding
obligations of deCODE under this Agreement shall cease immediately upon receipt
of notice of such termination; provided however, that deCODE's obligations to
reimburse for commitments and obligations incurred under any agreements
contemplated hereunder, such as the Crosswalk Development Agreement, any
Sponsored Research Agreements, Clinical Trial Agreements, License Agreements or
Software License Agreements, shall be governed solely by such agreements.
10.7 Effect of Expiration or Termination on Rights.
10.7.1 Upon the (1) the expiration of the Term pursuant to
Section 10.1, or (2) the earlier of: (i) such time as the Parties discontinue
marketing and sales of products and services pursuant to this Agreement, or (ii)
otherwise as determined by the Parties, such products and services have no
commercial value, or (3) termination of this Agreement by Institutions pursuant
to Section 10.2, or (4) termination of this Agreement by deCODE pursuant to
Section 10.4, or (5) termination of this Agreement by deCODE pursuant to Section
10.5 following a deCODE Notice, or (6) termination of the Crosswalk Development
Agreement by Institutions pursuant to Section 8.1 thereof, or (7) termination of
the Crosswalk Development Agreement by deCODE pursuant to Section 8.3 thereof,
then:
(a) Each Party shall thereafter have the
non-exclusive right to use the Crosswalk and any components of the Crosswalk,
and a non-exclusive license under the Crosswalk Intellectual Property Rights and
Crosswalk Information owned solely by the other Party (including the right and
license to use, copy, distribute and sublicense the Crosswalk Copyrightable
Works, including "joint works" or jointly-owned works as determined under the
United States Copyright Laws or the laws of any foreign jurisdiction, in any
country without the consent of the other Party and without the duty to account
to the other Party for any profits or
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royalties on account of such use, copying, distribution or sublicensing),
without obligation to such other Party, to facilitate studies with such Party's
own Database or for any purpose other than to facilitate studies with the other
Party's Database; and
(b) Each Party shall have the right to use the other
Party's Other Technology for which a Software License Agreement was entered into
to facilitate studies with such Party's own Database as provided for pursuant to
the terms of such Software License Agreement.
10.7.2 Upon the termination of this Agreement by deCODE
pursuant to Section 10.3, or termination of the Crosswalk Development Agreement
by deCODE pursuant to Section 8.2 thereof, where either such termination is
effective on or before the second anniversary of the Effective Date, or upon the
termination of this Agreement at any time by deCODE pursuant to Section 10.5
following an Institution Notice, then:
(a) deCODE shall thereafter have the exclusive right
to use the Crosswalk and any components of the Crosswalk, and an exclusive
license under the Crosswalk Intellectual Property Rights and Crosswalk
Information owned solely or jointly by Institutions (including the right and
license to use, copy, distribute and sublicense the Crosswalk Copyrightable
Works, including "joint works" or jointly-owned works as determined under the
United States Copyright Laws or the laws of any foreign jurisdiction, in any
country without the consent of Institutions and without the duty to account to
Institutions for any profits or royalties on account of such use, copying,
distribution or sublicensing), without obligation to Institutions, to facilitate
studies with the deCODE Database or for any purpose other than to facilitate
studies with Institution's Database;
(b) deCODE shall have the right to use any Other
Technology of any Institution for which a Software License Agreement was entered
into to facilitate studies with the deCODE Database as provided for pursuant to
the terms of such Software License Agreement;
(c) Institutions shall have no right to use the
Crosswalk or any components of the Crosswalk for any purpose, and all licensed
granted to Institutions by deCODE with respect to any Crosswalk Intellectual
Property Rights or Crosswalk Information shall cease; and
(d) Institutions' right to use any Other Technology
of deCODE for which a Software License Agreement was entered into shall
terminate as provided for pursuant to the terms of the respective Software
License Agreements;
provided, however, that Institutions shall continue to have the right to use any
Embedded Technology contributed by Institutions for use in the Crosswalk to
facilitate studies with the RPDR or for any purpose other than to facilitate
studies with the deCODE Database, and any Crosswalk Intellectual Property Rights
covering any such Embedded Technology.
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10.7.3 Upon the termination of this Agreement by deCODE
pursuant to Section 10.3 or termination of the Crosswalk Development Agreement
by deCODE pursuant to Section 8.2 thereof, where such termination is effective
after the second anniversary, but on or before the third anniversary, of the
Effective Date, subject to Section 10.1, then
(a) Each Party shall thereafter have the
non-exclusive right to use the Crosswalk and any components of the Crosswalk,
and a non-exclusive license under the Crosswalk Intellectual Property Rights and
Crosswalk Information owned solely by the other Party (including the right and
license to use, copy, distribute and sublicense the Crosswalk Copyrightable
Works, including "joint works" or jointly-owned works as determined under the
United States Copyright Laws or the laws of any foreign jurisdiction, in any
country without the consent of the other Party and without the duty to account
to the other Party for any profits or royalties on account of such use, copying,
distribution or sublicensing), without obligation to such other Party, to
facilitate studies (other than studies using the other Party's Database) for any
non-commercial internal research, education and patient care purposes, including
research for any state or federal agency, private or public foundation, except
foundations owned or operated by a commercial entity other than deCODE, but not
for commercially sponsored research or for private or public foundations which
have contractual obligations to commercial entities with respect to such
research or any other commercial applications;
(b) deCODE shall thereafter have the exclusive right
to use the Crosswalk and any components of the Crosswalk, and an exclusive
license under the Crosswalk Intellectual Property Rights and Crosswalk
Information owned solely or jointly by Institutions (including the right and
license to use, copy, distribute and sublicense the Crosswalk Copyrightable
Works, including "joint works" or jointly-owned works as determined under the
United States Copyright Laws or the laws of any foreign jurisdiction, in any
country without the consent of Institutions and without the duty to account to
Institutions for any profits or royalties on account of such use, copying,
distribution or sublicensing), without obligation to Institutions, to facilitate
studies with the deCODE Database or for any purpose other than those described
in Section 10.7.3(a) and other than to facilitate studies using Institution's
Database; and
(c) Each Party shall have the right to use the other
Party's Other Technology for which a Software License Agreement was entered into
to facilitate studies with such Party's own Database as provided for pursuant to
the terms of such Software License Agreement;
provided, however, that each Party shall continue to have the right to use any
Embedded Technology contributed by such Party for use in the Crosswalk to
facilitate studies with such Party's own Database or for any purpose other than
to facilitate studies with the other Party's Database, and any Crosswalk
Intellectual Property Rights covering any such Embedded Technology.
10.8 Return of Confidential Information. In the event that either
Party's right to use the Crosswalk is terminated pursuant to Section 10.7, such
Party shall return to the other Party such other Party's Confidential
Information, other than Confidential Information required to carry out
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any surviving rights under any other valid agreement between the Parties, and
one copy of such other Party's Confidential Information may be retained for such
Party's legal archives.
10.9 Other Agreements Unaffected. Termination of this Agreement shall
not terminate or otherwise affect any Sponsored Research Agreement, Crosswalk
Development Agreement, License Agreement, Software License Agreement or other
agreements between or among the deCODE and Institutions, or any of them, entered
into during the term of this Agreement, except as otherwise specifically
provided in this Agreement or in such other agreement.
11. Representations.
11.1 Representation of Authority; Consents. Each Party represents and
warrants to the other Party that, as of the Effective Date, it has full right,
power and authority to enter into this Agreement, this Agreement has been duly
executed by such Party and constitutes a legal, valid and binding obligation of
such Party, enforceable in accordance with its terms.
11.2 No Conflict. Each Party represents to the other Party that
notwithstanding anything to the contrary in this Agreement, the execution and
delivery of this Agreement and the performance of such Party's obligations
hereunder: (a) do not conflict with or violate such Party's Articles of
Incorporation and Bylaws, or other organizational documents, or any requirement
of applicable laws or regulations; and (b) do not and shall not conflict with,
violate, breach, constitute a default or require any consent under any
contractual obligation of such Party.
11.3 Knowledge of Pending or Threatened Litigation. Each Party
represents and warrants to the other Party that there is no claim,
investigation, suit, action or proceeding pending or, to the knowledge of such
Party, expressly threatened, against such Party before or by any governmental
entity or arbitrator that, individually or in the aggregate, could reasonably be
expected to: (a) materially impair the ability of such Party to perform its
obligations under this Agreement; or (b) prevent or materially delay or alter
the consummation of any or all of the transactions contemplated hereby.
12. Indemnification; Insurance.
12.1 Indemnification.
12.1.1 deCODE shall indemnify, defend and hold harmless
Institutions and their respective trustees, officers, medical and professional
staff, employees, and agents and their respective successors, heirs and assigns
(the "Institution Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorneys' fees and expenses of litigation) incurred by or
imposed upon the Institution Indemnitees or any one of them in connection with
any claims, suits, actions, demands or judgments of a third party to the extent
arising out of any breach of deCODE's representations and warranties set forth
in Section 11 or any theory of product liability (including, but not limited to,
actions in the form of tort, warranty, or strict liability) concerning any
product, process or service made, used or sold pursuant to any right or license
granted under this Agreement; and shall, at deCODE's own expense, provide
attorneys reasonably acceptable to
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Institutions to defend against any actions brought or filed against such
Institution Indemnitees whether or not such actions are rightfully brought.
12.1.2 Institutions, jointly and severally, shall indemnify,
defend and hold harmless deCODE and its directors, officers, professional staff,
employees, and agents and their respective successors, heirs and assigns (the
"deCODE Indemnitees"), against any liability, damage, loss or expense (including
reasonable attorneys' fees and expenses of litigation) incurred by or imposed
upon the deCODE Indemnitees or any one of them in connection with any claims,
suits, actions, demands or judgments of a third party to the extent arising out
of any breach of Institutions' representations and warranties set forth in
Section 11; and shall, at Institutions' own expense, provide attorneys
reasonably acceptable to deCODE to defend against any actions brought or filed
against such deCODE Indemnitees whether or not such actions are rightfully
brought.
12.1.3 deCODE's indemnification under Section 12.1.1 shall not
apply to any liability, damage, loss or expense to the extent that it is
directly attributable to the negligent activities, reckless misconduct or
intentional misconduct of the Institution Indemnitees.
12.1.4 This Section 12.1 shall survive expiration or
termination of this Agreement.
12.2 Insurance.
12.2.1 Beginning at such time as any such product, process or
service relating to use of the Crosswalk is being commercially distributed or
sold (other than for the purpose of obtaining regulatory approvals) by deCODE or
by a licensee, affiliate or agent of deCODE, deCODE shall procure and maintain,
at deCODE's sole expense, commercial liability insurance in amounts not less
than [CONFIDENTIAL TREATMENT REQUESTED] per incident and [CONFIDENTIAL TREATMENT
REQUESTED] annual aggregate and naming the Institution Indemnitees as additional
insureds. Such commercial liability insurance shall provide: (a) product
liability coverage; and (b) broad form contractual liability coverage for
deCODE's indemnification under Section 12.1. If deCODE elects to self-insure all
or part of the limits described above (including deductibles or retentions which
are in excess of [CONFIDENTIAL TREATMENT REQUESTED]annual aggregate) such
self-insurance program must be acceptable to Institutions and the Risk
Management Foundation. In the event deCODE's sublicensees elect to self-insure
all or part of such limits, such self-insurance program shall be deemed
acceptable to the Institutions and the Risk Management Foundation. The minimum
amounts of insurance coverage required under this Section 12.2 shall not be
construed to create a limit of deCODE's liability with respect to its
indemnification under Section 12.1.
12.2.2 deCODE shall provide Institutions with written evidence
of such insurance upon request of Institutions. deCODE shall provide
Institutions with written notice at least fifteen (15) days prior to the
cancellation, non-renewal or material change in such insurance; if deCODE does
not obtain replacement insurance providing comparable coverage prior to the
expiration of such fifteen (15) day period, Institutions shall have the right to
terminate this Agreement effective at the end of such fifteen (15) day period
without notice or any additional waiting periods.
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12.2.3 deCODE shall maintain such commercial liability
insurance beyond the expiration or termination of this Agreement during: (a) the
period that any such product, process, or service is being commercially
distributed or sold (other than for the purpose of obtaining regulatory
approvals) by deCODE or by a licensee, affiliate or agent of deCODE; and (b) a
reasonable period after the period referred to in clause (a), which in no event
shall be less than seven (7) years.
12.2.5 This Section 12.2 shall survive expiration or
termination of this Agreement.
12.3 Disclaimer. OTHER THAN THE REPRESENTATIONS AND WARRANTIES SET
FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR ANY
IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT,
COPYRIGHT, TRADEMARK, SOFTWARE, TRADE SECRET, TANGIBLE RESEARCH PROPERTY,
INFORMATION OR DATA LICENSED OR OTHERWISE PROVIDED TO THE OTHER PARTY HEREUNDER
AND HEREBY DISCLAIMS THE SAME.
13. Alternative Dispute Resolution.
13.1 Negotiation. The Parties shall attempt in good faith to resolve,
through negotiation, any dispute, claim or controversy arising out of or
relating to this Agreement. Either Party may initiate negotiations by providing
written notice in letter form to the other Party, setting forth the subject of
the dispute and the relief requested. The recipient of such notice shall respond
within five (5) days with a written statement of its position on, and
recommended solution to, the dispute. If the dispute is not resolved by this
exchange of correspondence, then representatives of each Party with full
settlement authority shall meet at a mutually agreeable time and place within
ten (10) days of the date of the initial notice in order to exchange relevant
information and perspectives, and to attempt to resolve the dispute.
13.2 Arbitration. Except with respect to breaches for which a Party is
seeking injunctive relief, all disputes between the Parties relating to this
Agreement or the subject matter hereof which cannot be resolved by the Parties
according to Section 13.1 shall be submitted for final and binding arbitration
before JAMS/Endispute ("JAMS") pursuant to the United States Arbitration Act, 9
U.S.C. Section 1 et seq., and shall be held at a mutually agreeable location or
in New York City. Either Party may commence the arbitration process pursuant to
this Agreement by filing a written demand for arbitration with JAMS, with a copy
to the other Party. Unless the Parties otherwise agree in writing, the
arbitration shall be conducted in accordance with the provisions of JAMS
Comprehensive Arbitration Rules and Procedures in effect at the time of filing
of the demand for arbitration if the amount in controversy is greater than
$250,000, exclusive of interest; or the arbitration shall be conducted in
accordance with the provisions of JAMS Streamlined Arbitration Rules and
Procedures in effect at the time of filing of the demand for arbitration if the
amount in controversy is $250,000 or less, exclusive of interest; provided
however, that all arbitrators must be knowledgeable and experienced in the
biotechnology and bioinformatics industries and, in the case of a dispute
concerning the Crosswalk, the software
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27
development industry, and must not be affiliated through employment or otherwise
with a competitor of any Party, as determined through mutual assent of the
Parties. The Parties shall cooperate with JAMS and with one another in selecting
an arbitrator from JAMS' panel of neutrals, and in scheduling the arbitration
proceedings. The Parties shall participate in the arbitration in good faith, and
shall share equally in its costs. The provisions of this Section may be enforced
by any court of competent jurisdiction, and the Party seeking enforcement shall
be entitled to an award of all costs, fees and expenses, including attorneys'
fees, to be paid by the Party against whom enforcement is ordered.
13.3 Injunctive Relief. This Section 13 shall not prohibit a Party from
seeking injunctive relief from a court of competent jurisdiction in the event of
a breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
13.4 Prohibited Database Use. Notwithstanding this Section 13, any
Party may prohibit (the "Prohibiting Party") another's use of the Prohibiting
Party's Database where such Prohibiting Party determines in good faith that such
use contravenes the Prohibiting Party's internal use policies concerning such
Database. Such prohibition shall in no way limit the liability of the
Prohibiting Party for damages.
14. Miscellaneous.
14.1 Governing Law. This Agreement shall be governed by, construed, and
interpreted in accordance with the laws of the State of Delaware, without
reference to principles of conflicts of laws.
14.2 Independent Contractors. No Party shall have the right to direct
or control the activities of any other Party or other Party's personnel in the
performance of activities under this Agreement, and each Party shall act
hereunder only as an independent contractor; nothing herein contained shall be
construed to be inconsistent with that relationship or status. Under no
circumstances shall Institution or any Institution Personnel be considered to be
an employee or agent of deCODE, or deCODE or any deCODE Personnel be considered
any employee or agent of any Institution. This Agreement shall not constitute,
create, or in any way be interpreted as a joint venture, partnership or formal
business organization of any kind.
14.3 Assignment. No Party shall assign its rights or duties under this
Agreement to another without the prior express written consent of the other
Parties, which consent shall not be unreasonably withheld; provided, however,
that any Party may assign this Agreement to a successor in ownership of all or
substantially all its business assets. Such successor shall expressly assume in
writing the obligation to perform in accordance with the terms and conditions of
this Agreement.
14.4 Entire Agreement. This Agreement, the Sponsored Research
Agreements and Clinical Trial Agreements (including any License Agreements
entered into pursuant thereto), Software License Agreements, and the Crosswalk
Development Agreement constitute the entire and only agreements among the
Parties relating to the subject matter hereof, and all prior
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negotiations, representations, agreements and understandings are superseded by
this Agreement.
14.5 Notices. All notices, demands and other communications of every
kind and description whatsoever required or permitted under this Agreement shall
be in writing and shall be deemed to have been received when personally
delivered, or when shipped by private express carrier (signature required),
shipment charges prepaid, or when sent via facsimile transmission (receipt
verified) to the Party to whom delivery shall be made at the respective
addresses as set out below.
If to Partners, to: With a copy to:
Partners HealthCare System, Inc. Partners HealthCare System, Inc.
Prudential Tower, 000 Xxxxxxxx Xxxxxx Prudential Tower, 000 Xxxxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000-0000 Xxxxxx, Xxxxxxxxxxxxx 00000-0000
Attn: Crosswalk Coordinator Attn: Vice President, Corporate
Institution Agreement #________ Sponsored Research and Licensing
Telephone: (000) 000-0000 Telephone: (000) 000-0000
Facsimile: (000) 000-0000 Facsimile: (000) 000-0000
If to MGH, to: If to BWH, to:
Massachusetts General Hospital The Xxxxxxx and Women's Hospital, Inc.
000 00xx Xxxxxx, Xxxxx 0000 0000 Xxxxxxxx Xx., Xxxxx 000
Xxxxxxxxxxx, Xxxxxxxxxxxxx 00000 Xxxxxx, Xxxxxxxxxxxxx 00000
Attn: Director, Corporate Sponsored Attn: Director, Corporate Sponsored
Research and Licensing Research and Licensing
Institution Agreement #2000A001262 Institution Agreement #A3328
Telephone: (000) 000-0000 Telephone: (000) 000-0000
Facsimile: (000) 000-0000 Facsimile: (000) 000-0000
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If to deCODE, to:
deCODE genetics Ltd.
Xxxxxxxxx 0
XX-000 Xxxxxxxxx, Xxxxxxx
Attn: Crosswalk Coordinator
Telephone: x000-000-0000
Facsimile: x000-000-0000
14.6 Modification. No modification or waiver of this Agreement or of
any covenant, condition, or limitation herein contained shall be valid unless in
writing and duly executed by all Parties.
14.7 Waiver. No waiver of any rights shall be effective unless assented
to in writing by the Party to be charged with such waiver, and the waiver of any
breach or default shall not constitute a waiver of any other right hereunder or
any subsequent breach or default.
14.8 Headings. The Section headings are intended for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
14.9 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and effect
without said provision; provided, however, that no such severability shall be
effective if the result of such action materially changes the economic benefit
of this Agreement to deCODE or to Institutions.
14.10 Construction. The Parties have participated equally in the
creation of this Agreement; the language of this Agreement shall not be
presumptively construed against either Party.
14.11. Survival. The provisions of Sections 1, 2.4.2, 5, 8, 9, 10.6
through 10.9, 12, 13, 14.1, 14.9, 14.10 and 14.11 shall survive any expiration
or termination of this Agreement.
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14.12 Counterparts. This Agreement may be executed in counterparts,
each of which shall constitute an original document, but all of which together
shall constitute one and the same agreement.
* * *
In witness whereof, each Institution and deCODE have caused this
Agreement to be executed by their duly authorized representatives as of the date
first set forth above.
PARTNERS HEALTHCARE SYSTEM, INC. DECODE GENETICS LTD.
BY: __/s/ Xxxxxx Braunwald_______ BY: ___/s/ Xxxx Stefansson________
NAME: __Eugene Braunwald_______ NAME: ___Kari Stefansson________
TITLE: __V.P. Academic Programs__ TITLE: __President and CEO_______
DATE: ___ 5/16/2000_____________ DATE: ___5/11/2000_____________
THE GENERAL HOSPITAL CORPORATION THE XXXXXXX AND WOMEN'S HOSPITAL,
D.B.A. MASSACHUSETTS GENERAL HOSPITAL INC.
BY: __/s/ Xxxxxx X. Guthrie______ BY: ___/s/ Xxxxx X. Hicks_________
NAME: __Marvin C. Xxxxxxx, X.X._ NAME: ___Brian N. Hicks_________
TITLE: _V.P. Patents, Licensing__ TITLE: ____Director, Corporate____
and Industry Sponsored Sponsored Research
Research and Licensing
DATE: _11_May_2000_____________ DATE: ___5/12/2000______________
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APPENDIX A
SPONSORED RESEARCH AGREEMENT
00
XXXXXXXX X
CLINICAL TRIAL AGREEMENT
33
APPENDIX C
CROSSWALK DEVELOPMENT AGREEMENT
34
APPENDIX D
JOINT PUBLIC ANNOUNCEMENT
00
XXXXXXXX X
SOFTWARE LICENSE AGREEMENT
36
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.]
SPONSORED RESEARCH AGREEMENT
BETWEEN
[NAME OF INSTITUTION(S)]
AND
DECODE GENETICS LTD.
DATED ____________, 2000
37
SPONSORED RESEARCH AGREEMENT
THIS SPONSORED RESEARCH AGREEMENT (the "Agreement"), effective
__________, 2000 ("Effective Date"), is by and between [name of Partners'
Institution] (for example, The General Hospital Corporation d.b.a. Massachusetts
General Hospital, a Massachusetts not-for-profit corporation having its
principal offices at 00 Xxxxx Xxxxxx, Xxxxxx, XX 00000, or The Xxxxxxx and
Women's Hospital, Inc., a Massachusetts not-for-profit corporation having its
principal offices at 00 Xxxxxxx Xxxxxx, Xxxxxx, XX 02115) ("Institution"),
acting on behalf of Dr._________, and deCODE genetics Ltd., an Icelandic
corporation which is a wholly-owned subsidiary of deCODE genetics, Inc., a
Delaware corporation, and having its principal offices at Xxxxxxxxx 0, XX-000
Xxxxxxxxx, Xxxxxxx ("deCODE") (Institution and deCODE, each a "Party;"
collectively, the "Parties").
BACKGROUND
Institution has ongoing research in the area of ______ conducted by Dr.
_________________, and desires to obtain funding and technical support from
deCODE to further such research. deCODE wishes to obtain from Institution an
option to obtain certain rights to inventions and copyrights that are developed
during the course of research funded by deCODE hereunder.
The Parties have, therefore, agreed as follows:
1. Definitions.
1.1 "Collaborator" shall mean with respect to a Party, a third party
with whom such Party has agreed jointly to research and/or develop one or more
products or services relating to or based upon the Research.
1.2 "Confidential Information" of a Party shall mean (a) all technical
or marketing reports, data or information disclosed by such Party to the other
Party which is in writing and marked "Confidential," "Proprietary" or the like,
or, if disclosed orally, is indicated as confidential at the time of disclosure
and is summarized in writing and marked or otherwise designated in writing as
"Confidential," "Proprietary" or the like within thirty (30) days after such
disclosure, and (b) all source code or object code disclosed by such Party to
the other Party; provided however, Research Data other than deCODE Research Data
set forth in Appendix E shall not be considered Confidential Information of the
disclosing Party.
1.3 "Copyright" shall mean the copyright subsisting in accordance with
United States Copyright Law, foreign copyright laws and international agreements
in the Copyrightable Work, together with any United States or foreign copyright
registration application or resulting copyright registration.
1.4 "Copyrightable Work" shall mean any original work of authorship
fixed in any tangible medium of expression, now known or later developed, from
which it can be perceived,
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reproduced, or otherwise communicated, either directly or with the aid of a
machine or device, including without limitation computer programs and related
documentation, which is authored by any Investigator solely or jointly with
deCODE or deCODE personnel in the performance of Research, or prepared by any
Investigator in the performance of Research and within the scope of his or her
employment by Institution as a Work-Made-For-Hire (as that capitalized term is
defined in United States Copyright Law) for which Institution is considered the
author and owner solely or jointly with deCODE or deCODE personnel.
Notwithstanding the foregoing, as used herein, "Copyrightable Work" shall
exclude (a) databases and (b) works authored by any Investigator of an academic
or scholarly nature such as notebooks, textbooks, publications or abstracts in
scientific journals or presentations, regardless of whether such works were
created in performance of the Research.
1.5 "Crosswalk Development Agreement" shall mean the agreement between
Partners Healthcare Systems, Inc., The General Hospital Corporation d.b.a.
Massachusetts General Hospital, The Xxxxxxx and Women's Hospital and deCODE
dated May 11, 2000.
1.6 "CSRL" shall mean the Institution's Corporate Sponsored Research
and Licensing office, or any successor thereto.
1.7 "deCODE" shall have the meaning assigned to such term in the
Introductory paragraph.
1.8 "deCODE Materials" shall mean any biological material or substance
first discovered, produced or made by an employee of deCODE or otherwise to
which deCODE has rights and which deCODE provides to Institution in connection
with the Research pursuant to this Agreement; provided however, that deCODE
Materials shall not include tissues, bodily fluids, or other materials from
patients, including without limitation genetic material.
1.9 "deCODE Notice" shall have the meaning assigned to such term in the
Strategic Alliance Agreement.
1.10 "deCODE Representative" shall be ____________________, or such
other representative as deCODE may subsequently designate in writing, who shall
be responsible for the communications and collaboration with Institution
relating to the Research.
1.11 "deCODE Research Data" shall mean any research data, formulae,
process information or other information pertaining to the Research produced by
a deCODE employee or consultant in the performance of, or relating to, the
Research, including without limitation any research data, formulae, process
information or other information provided by deCODE to Institution or
Investigators for the purpose of performing or in connection with the
performance of the Research. Notwithstanding the foregoing, the term "deCODE
Research Data" shall not include patient identifiers or other patient
confidential information.
1.12 "Effective Date" shall have the meaning assigned to such term in
the Introductory paragraph.
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1.13 "Field of Research" shall mean ___________ [TO BE DEFINED TAKING
INTO CONSIDERATION ITS USE IN SECTION 2.4].
1.14 "Institution" shall have the meaning assigned to such term in the
Introductory paragraph.
1.15 "Institution Materials" shall mean any biological material or
substance first discovered, produced or made by an Investigator in the
performance of Research; provided, however, that Institution Materials shall not
include tissues, bodily fluids, or other materials from patients, including
without limitation genetic material.
1.16 "Institution Notice" shall have the meaning assigned to such term
in the Strategic Alliance Agreement.
1.17 "Institution Research Data" shall mean any research data,
formulae, process information or other information pertaining to the Research
produced by an Investigator in the performance of Research, but shall not
include patient identifiers or other patient confidential information.
1.18 "Intellectual Property Rights" shall mean the statutory rights and
protection afforded Patent Rights and/or Copyrightable Works by the patent and
copyright laws of the country where such right is sought, it being understood
that any individual category of intellectual property may be afforded more than
one such statutory right.
1.19 "Invention" shall mean any new and useful process, machine,
manufacture, or composition of matter in the Field of Research conceived and
reduced to practice, solely or jointly, by any Investigator in the performance
of Research.
1.20 "Investigator" shall mean the Principal Investigator and any other
member of Institution's Professional Staff, graduate student, undergraduate
student, or employee of Institution who shall perform Research under the
direction of the Principal Investigator.
1.21 "IP Costs" shall have the meaning assigned to such term in Section
7.5.
1.22 "IP Project Leader" shall have the meaning assigned to such term
in the Strategic Alliance Agreement.
1.23 "JAMS" shall have the meaning assigned to such term in Section
13.2.
1.24 "Joint Copyrightable Work" shall have the meaning assigned to such
term in Section 7.3.
1.25 "Joint Invention" shall have the meaning assigned to such term in
Section 7.3.
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1.26 "Joint Research Data" shall mean any research data, formulae,
process information or other information pertaining to the Research which is
jointly produced by one or more Investigators and one or more deCODE employees
or consultants in the performance of Research, but does not include patient
identifiers or other patient confidential information.
1.27 "Materials" shall mean deCODE Materials and Institution Materials,
collectively.
1.28 "Party" or "Parties" shall have the meanings assigned to such
terms in the Introductory paragraph.
1.29 "Patent Right" shall mean any United States patent application,
including any division or continuation and any foreign patent application or
equivalent corresponding thereto and any Letters Patent or the equivalent
thereof issuing thereon or reissue or extension thereof, which contains one or
more claims to an Invention. Patent Rights shall also include those claims of
any continuation-in-part of the aforementioned patent applications to the extent
they claim an Invention.
1.30 "Patient Tissues" shall mean any tissues, bodily fluids, or other
materials from patients, including without limitation genetic material.
1.31 "Performance Period" shall mean the period during which
Investigators shall conduct the Research pursuant to the Work Plan, beginning on
the Effective Date and ending (a)_____ ( ) year(s) from the Effective Date, and
any extension thereof mutually agreed upon by the Parties in writing, or (b) on
the date this Agreement is terminated pursuant to Sections 2.3 or 12, whichever
shall occur first.
1.32 "Principal Investigator" shall mean , who shall be
responsible for the direction and conduct of the Research at Institution.
1.33 "Research" shall mean the research program described in the Work
Plan attached as Appendix A, entitled __________________, that is funded in
whole or in part by deCODE and performed by an Investigator solely or jointly
with deCODE under this Agreement.
1.34 "Research Data" shall mean deCODE Research Data, Institution
Research Data and Joint Research Data, collectively.
1.35 "Software License Agreement" shall mean the agreement between
Partners Healthcare Systems, Inc., The General Hospital Corporation d.b.a.
Massachusetts General Hospital, The Xxxxxxx and Women's Hospital and deCODE
dated ___________, 2000.
1.36 "Strategic Alliance Agreement" shall mean the agreement between
Partners Healthcare Systems, Inc., The General Hospital Corporation d.b.a.
Massachusetts General Hospital, The Xxxxxxx and Women's Hospital and deCODE
dated May 11, 2000.
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1.37 "Third Party Project" shall have the meaning assigned to such term
in Section 2.4.2.
1.38 "Transfer Letter" shall mean the correspondence to accompany the
transfer of Materials, in substantially the same form as that attached as
Appendix C.
1.39 "Work Plan" shall have the meaning assigned to such term in
Section 2.1.
2. Scope of Work.
2.1 Work Plan. The scope of the Research, including research goals and
objectives, to be performed by Institution through the laboratory of the
Principal Investigator is described in Appendix A (the "Work Plan").
2.2 Performance of Research. Institution, through the laboratory of the
Principal Investigator, shall use all reasonable efforts to perform the Research
in accordance with the Work Plan. The Research shall be conducted in the
laboratory, and under the direction and supervision, of the Principal
Investigator.
2.3 Change in Principal Investigator. If for any reason Dr. __________
is unable to fulfill the responsibilities of the Principal Investigator required
to carry out the Research, the Parties shall negotiate in good faith the
continuance of the Research under the direction and supervision of a different
Principal Investigator. However, if another Principal Investigator satisfactory
to deCODE cannot be agreed upon, then deCODE may terminate this Agreement
immediately upon giving notice thereof.
2.4 Exclusivity.
2.4.1 At any time during the term of this Agreement, either
Party may propose in writing additional research in the Field of Research not
previously described in the Work Plan for the Research as set forth in Appendix
A. Each such proposal shall include a description of the additional research
proposed, a budget of the costs to be funded by deCODE, and a schedule of
payment of such costs. Unless the Parties shall otherwise agree in writing,
negotiations between them over any such proposal shall not extend beyond the
sixtieth (60th) day next following the date when the proposal shall have first
been so made, and whenever such negotiations shall end without agreement between
the Parties to proceed with the proposed research, the Party proposing the
additional research may proceed without the other Party and seek funding from
any other sponsor, including but not limited to a commercial sponsor, as set
forth in Section 2.4.2. When such proposal is accepted by Institution and
deCODE, it shall be appended hereto as an addendum to the Work Plan and shall be
subject to the terms and conditions of this Agreement unless otherwise
specified, and the Research described therein shall commence and budgeted
amounts shall be paid as set forth in the proposal or as otherwise agreed by the
Parties in writing. In no event shall any additional research be added to the
Research nor shall the direction of Research be altered without the concurrence
of the Director of CSRL of the Institution.
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2.4.2 Notwithstanding any contrary provision, an Investigator
shall not seek funding from another commercial sponsor for an additional
research proposal in the Field of Research unless and until such proposal has
been submitted to deCODE in accordance with the foregoing Section 2.4.1 and the
Parties have failed to agree in writing to append such proposal hereto as an
addendum to the Work Plan within the stipulated sixty (60) days. In the event of
such failure to agree, an Investigator shall be free to seek and accept funding
from such commercial sponsor for such research proposal (the "Third Party
Project"), provided that, in the reasonable determination of the Joint Steering
Committee created pursuant to the Strategic Alliance Agreement, after
consultation with the Investigator: (a) the subject matter of the Third Party
Project is not so closely related scientifically to the Research that
sponsorship of such Third Party Project by such other commercial sponsor would
create a conflict of interest for Institution or any Investigator performing the
Research; (b) the risk of subject matter overlaps between the Research and such
Third Party Project is minimal; (c) the Third Party Project would not conflict
with the terms and conditions of this Agreement and would not have a material
impact on the Research or Institution's ability to perform the Research; and (d)
such other commercial sponsor of the Third Party Project is not a competitor of
deCODE in any of its business areas that would create a conflict of interest.
2.4.3 An Investigator shall be free at any time to seek
funding for any research in the Field of Research, including additional funding
for the Research, from any international, federal or state agencies, or from any
not-for-profit foundations except foundations owned or operated by a commercial
entity other than deCODE or which have obligations to commercial entities with
respect to such research; provided, however, that such Investigator shall follow
the procedures set forth in Section 6 with respect to any grant applications and
progress reports disclosing Research Data.
2.4.4 Investigators shall be free at any time to seek funding
from any source for any research outside the Field of Research.
3. Payments.
3.1 Amount. Payments to Institution in support of the Research during
the Performance Period shall be made in advance as follows:
$______________on [DATE] ____________;
$______________on [DATE] ____________;
$______________on [DATE] ____________;
for a total payment of $______________________ as set forth in the attached
Appendix B, entitled "Budget." Such funds shall be used to support the direct
and attendant indirect costs (as determined by Institution's policies on
indirect cost, as communicated to deCODE from time to time) of the Research. All
of such funding of direct costs shall be used by Institution as deemed necessary
and appropriate by the Principal Investigator to carry out the Research and
achieve the research goals and objectives set forth in the Work Plan.
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3.2 Payment Method. Checks for all payments to Institution under this
Agreement shall reference Agreement number _____and be made payable to:
NAME: _________________________________________
ATTN: Director, Corporate Sponsored Research and Licensing
(INSTITUTION'S CSRL ADDRESS)
____________________________
____________________________
____________________________
Institution Agreement #_____
3.3 Payment Records; Audit Rights. Institution shall maintain records
of its expenditures of funds received under this Agreement in accordance with
its customary accounting policies and procedures and shall provide to deCODE a
summary of its expenditures within ninety (90) days after the end of each
elapsed year during the Performance Period. During the Performance Period and
for two years thereafter, deCODE, on reasonable notice, during normal business
hours and at its own expense, may examine Institution's accounting records with
respect to expenditures under this Agreement. In the event that any funds were
paid by deCODE to Institution and not used during the Performance Period,
Institution may retain such excess amount if Institution agrees to extend the
Performance Period and continue to use such funds to further the Research
conducted under this Agreement under the auspices of the Principal Investigator,
in which case all rights to such research and the results thereof shall be
granted to deCODE to the same extent as provided in this Agreement with respect
to the Research.
4. Transmission of, and Rights To Use, Institution Materials and deCODE
Materials.
4.1 Use of deCODE Materials by Institution. Institution and Principal
Investigator shall not distribute deCODE Materials to anyone other than
Investigators or use them for any purpose other than Research without the prior
written approval of deCODE.
4.2 Use of Institution Materials by deCODE. Upon deCODE's request,
Principal Investigator shall provide deCODE with an amount of such Institution
Materials as is reasonably requested and shall not interfere with Investigators'
ability to conduct Research. deCODE shall have the right to use Institution
Materials provided to it for: (a) any commercial purposes, including but not
limited to the development, manufacture, sale and use of any product; (b) for
research and development purposes, provided, however, that uses that may lead to
publications are discussed in advance with the Principal Investigator and that
Investigators who produced the Institution Materials are given credit in
accordance with scientific custom, by acknowledgment or co-authorship as
appropriate, in any resulting publications; and (c) transfers to third parties;
provided, however, that deCODE has obtained the prior written permission of the
Principal Investigator for such transfers.
4.3 Transfer Letters. Institution Materials provided to deCODE and
deCODE Materials provided to Investigators shall be accompanied by, and subject
to the terms of, a Transfer Letter in substantially the same form as that
attached as Appendix C.
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4.4 Use of Institution Materials by Institution.
4.4.1 During the period Research is being performed hereunder,
Institution and Principal Investigator shall have the right to transfer
Institution Materials to not-for-profit entities or persons known to be
affiliated therewith, provided that such entities or persons agree in writing
not to: (a) transfer such Institution Materials to any other person or entity;
and (b) use such Institution Materials for commercial purposes.
4.4.2 During the period Research is being performed hereunder,
Institution and Principal Investigator shall not, without deCODE's prior written
approval, distribute or knowingly allow to be distributed Institution Materials
to for-profit entities or persons known to be employed thereby or performing
research sponsored thereby in the Field of Research unless:
(a) A description of the Institution Materials is
published in a journal that requires dissemination of described materials as a
condition for publication;
(b) Institution and deCODE have mutually agreed not
to seek Patent Rights claiming such Institution Materials or its manufacture or
use; or
(c) Such distribution is required by the policies,
regulations or guidelines of the U.S. government.
4.4.3 Under the circumstances described in 4.4.2(a), (b) or
(c), Institution and Principal Investigator shall have the right to distribute
such Institution Materials to:
(a) Such entities or persons who agree in writing not
to (i) transfer such Institution Materials to any other person or entity; and
(ii) use such Institution Materials for commercial purposes; and
(b) Third persons solely for the purpose of obtaining
chemical, physical, or biological analysis or characterization of such
Institution Materials, provided that such persons agree in writing not to (i)
transfer such Institution Materials or any non-public information regarding such
Institution Materials to any other person or entity; and (ii) use such
Institution Materials for any purpose other than the agreed-upon analysis or
characterization and not to disclose such analysis or characterization to any
third party.
4.5 Transfer Agreement for Patient Tissues. In the event that any
Patient Tissues are to be transferred from Institution to deCODE for the
purposes of this Agreement, such Patient Tissues shall be provided under the
terms and conditions of a Transfer Agreement for Patient Tissue Samples in
substantially the same form as that attached as Appendix D.
5. Technical Reports and Use of Research Data.
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5.1 Final Report. Within sixty (60) days after the completion of the
Research, the Principal Investigator shall submit a comprehensive final report
regarding all data, information and materials obtained from the Research to
deCODE. In addition, the Principal Investigator shall submit other periodic
reports as may be provided for in the Work Plan.
5.2 Use of Research Data by deCODE. deCODE shall have the right to use
the Institution Research Data and Joint Research Data to the extent that such
use does not infringe any Patent Rights of Institution not expressly licensed to
deCODE. deCODE shall not provide any unpublished Institution Research Data to
any third party without the Principal Investigator's prior written permission,
except that deCODE may provide such unpublished Institution Research Data to its
Collaborators and licensees, in confidence, without such consent. deCODE shall
have the right to use deCODE Research Data for any purpose without the consent
of Institution.
5.3 Use of Research Data by Investigators and Institution.
Investigators and Institution shall have the right to use and disclose Research
Data for research, education and patient care purposes; provided, however, that
Investigators or Institution, as the case may be, shall follow the procedures
set forth in Section 6 for notification to or review by deCODE of public oral
presentations, manuscripts, abstracts, progress reports and grants containing
Research Data.
5.4 deCODE Research Data to be Treated as Confidential Information.
From time to time, Principal Investigator and deCODE shall discuss the use and
disclosure of deCODE Research Data. Any deCODE Research Data developed prior to
the Effective Date which Principal Investigator and deCODE agree are to be
treated by Investigators and Institution as Confidential Information in
accordance with Section 11 shall be set forth in Appendix E. Principal
Investigator shall give careful consideration to the consequences of his or her
inability to publish such deCODE Research Data or use such deCODE Research Data
in grant applications or progress reports. In the event that Principal
Investigator wishes to use or disclose any deCODE Research Data which are
developed after the Effective Date, Principal Investigator shall obtain, prior
to accepting such deCODE Research Data, deCODE's written permission to use or
disclose such deCODE Research Data; or, alternatively, Principal Investigator
and deCODE shall agree that such deCODE Research Data are to be treated as
Confidential Information and such deCODE Research Data shall be added to
Appendix E.
6. Publications and Reports Containing Research Data.
6.1 Submission. Prior to public presentation or submission to a
journal, international, federal or state agency, or not-for-profit foundation,
as the case may be, the Principal Investigator shall submit for review to the
deCODE Representative an early draft of any manuscript, abstract, public oral
presentation, or progress report containing Research Data.
6.2 Review Period. Within thirty (30) days of receipt of such
manuscript or progress report, or within seven (7) days of receipt of an
abstract or public oral presentation from the Principal Investigator, deCODE
shall submit its comments, if any, to the Principal Investigator. The
Investigators shall give due consideration to any comments made by deCODE, but
shall not
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be required to incorporate any of deCODE's comments, and the
Investigators' decision as to the information to be contained in such
manuscript, progress report, presentation, or abstract shall be final, except
that upon deCODE's notification, the Investigators shall delete any of deCODE's
Confidential Information and deCODE Research Data set forth on Appendix E. In
any publication, progress report or presentation containing Research Data, each
Party shall acknowledge the role and contribution of the other Party to the
Research.
6.3 Delay for Patent Filing. If deCODE has reason to believe that any
such manuscript, abstract, presentation, or progress report or any grant
application provided in accordance with Section 6.5 reveals a potentially
patentable Invention, deCODE shall notify the Principal Investigator and
Institution in writing within the time periods indicated in Section 6.2, 6.4 or
6.5, as the case may be. In such case, the Investigators agree to delay
submission for publication, public presentation, or submission to an agency or
not-for-profit foundation, as the case may be, until the earlier to occur of the
following:
6.3.1 A U.S. patent application has been filed;
6.3.2 Institution's CSRL has determined, in consultation with
deCODE, that no patentable Invention exists; or
6.3.3 Sixty (60) days have passed from the date of such
notification by deCODE.
6.4 Competitive Publications. If a deCODE employee or Investigator
receives reasonable indications concerning the imminent oral presentation or
publication of a manuscript or abstract by a third party that is similar in
content to the presentation, manuscript or abstract containing Research Data
proposed to be published or presented by an Investigator or deCODE employee, the
Parties agree as follows:
6.4.1 The deCODE employee or Investigator shall notify the
other Party in writing as soon as reasonably practical about such other imminent
presentation or publication; and
6.4.2 The time periods for presentation or publication review
and delay stated in Sections 6.1, 6.2 and 6.3 shall be shortened as mutually
agreed.
6.5 Grant Submissions. Investigators shall have the right to submit
grant applications disclosing any Research Data, except for deCODE Research Data
set forth in Appendix E, or the nature of the relationship among the Parties to
any international, federal, or state agencies or not-for-profit foundations
which do not require licensing to a commercial entity; provided, however, that
such Investigators shall provide a draft of such grant applications to deCODE at
least fifteen (15) days prior to submission to such agencies or foundations. In
the event that an Investigator wants to exclude from review any portions of a
grant application that do not disclose any Research Data or the nature of the
relationship among the Parties, then such Investigator shall provide to deCODE:
(i) a draft of all other portions of such grant application, including all
portions disclosing any Research Data; and (ii) a certification from the
Principal Investigator and IP Project Leader that deCODE has been provided with
all portions of such grant application
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disclosing Research Data and all portions reasonably necessary for
deCODE to determine whether such grant application reveals a potentially
patentable Invention. In such event, deCODE may request additional information
as it deems reasonably necessary or desirable to make such a determination. Such
grant submission shall be subject to Section 6.3. When so requested by deCODE,
Institution and Investigators shall indicate on such grant application that
certain proprietary business information is contained therein which is not
subject to disclosure under the Freedom of Information Act, and shall request
that such information be treated as confidential.
7. Intellectual Property Rights.
7.1 Ownership by Institution. Each Investigator who shall (a) solely or
jointly make an Invention or (b) solely or jointly author or prepare a
Copyrightable Work, shall promptly report such Invention or Copyrightable Work
to the Institution. Such Investigator shall assign all of his or her rights,
title and interest in any such Invention, including any Patent Rights, or in any
such Copyrightable Work to the Institution (to the extent that such
Copyrightable Work is not already owned by such Institution as a
Work-Made-For-Hire under United States Copyright Law).
7.2 Ownership by deCODE. Each deCODE employee who shall (a) solely or
jointly make a Invention or (b) solely or jointly author or prepare a
Copyrightable Work, shall promptly report such Invention or Copyrightable Work
to deCODE. Such deCODE employee shall assign all of his or her rights, title and
interest in any such Invention, including any Patent Rights, or in any such
Copyrightable Work to deCODE (to the extent that such Copyrightable Work is not
already owned by deCODE as a Work-Made-For-Hire under United States Copyright
Law).
7.3 Joint Ownership. If an Invention is invented by one or more
Investigator(s) and one or more deCODE employee(s), such Investigator(s) and
deCODE employee(s) shall assign all of their right, title and interest in any
such Invention (a "Joint Invention") to their respective employers. If a
Copyrightable Work is authored or created by one or more Investigator(s) and one
or more deCODE employee(s) (a "Joint Copyrightable Work"), such Investigator(s)
and deCODE employee(s) shall assign all of their rights, title and interest in
such Joint Copyrightable Work to their respective employers (to the extent that
such deCODE employees' and Investigators' contributions to such Joint
Copyrightable Work is not already owned by deCODE or the Institution as a
Work-Made-For-Hire under United States Copyright Law). For each Joint Invention,
the Institution to which such Joint Invention is assigned and deCODE shall each
own an undivided interest in such Invention in each country in which it is filed
and granted. For each Joint Copyrightable Work, the Institution to which such
Copyrightable Work is assigned and deCODE shall each own an undivided interest
in such Copyright in each country where Copyright protection results. Such
Institution and deCODE shall each have the right to sell, license or
otherwise transfer its rights to such Joint Invention or Joint Copyrightable
Work in any country without the consent of the other; provided, however,
that the Institutions shall be subject to the terms and conditions of
this Agreement and the Strategic Alliance Agreement.
7.4 Disclosure between Parties. Each Party shall promptly advise the
other in writing of each: (a) Invention, including without limitation any Joint
Invention; or (b) Copyrightable Work, including without limitation any Joint
Copyrightable Work, disclosed to it.
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Representatives of Institution and deCODE shall then discuss whether
applications for Intellectual Property Rights shall be sought and in which
countries. If both Parties mutually agree that such application(s) should be
filed, applications assigned solely to Institution shall be filed by
Institution, applications assigned solely to deCODE shall be filed by deCODE,
and jointly assigned applications shall be filed as mutually agreed upon by the
Parties. The titles, serial numbers and other identifying data of any
applications for Intellectual Property Rights shall be added to Appendix F of
this Agreement.
7.5 Costs. Reasonable and customary costs incurred by Institution for
filing, obtaining and maintaining Intellectual Property Rights filed by mutual
agreement ("IP Costs") shall be reimbursed in full by deCODE upon deCODE's
receipt of Institution's notice of payment of such IP Costs, except as provided
for below. Such IP Costs shall include but not be limited to the costs of
preparing, filing, prosecuting (including mutually agreed upon interferences or
oppositions), issuing or maintaining and working Intellectual Property Rights,
including without limitation the Patent Rights and Copyrights. For IP Costs not
reimbursed by deCODE within thirty (30) days after receipt of Institution's
notice of payment of such IP Costs, deCODE shall pay Institution interest at the
rate of [CONFIDENTIAL TREATMENT REQUESTED] per month compounded each month that
such IP Costs remain unpaid. For Intellectual Property Rights in which other
commercial entities have acquired license rights, deCODE shall reimburse
Institution only for the same share of such IP Costs as reimbursed by each of
the other commercial entities, but in no event shall deCODE be required to
reimburse Institution for more than [CONFIDENTIAL TREATMENT REQUESTED] of the IP
Costs for such Intellectual Property Rights.
7.6 deCODE Waives Filing. In the event deCODE is interested in having
Intellectual Property Rights filed with respect to a particular Invention or
Copyrightable Work made solely by Investigators, deCODE shall advise Institution
of such interest, in writing, within ninety (90) days from the date on which the
Invention or Copyrightable Work was disclosed to deCODE by Institution or
sooner, as specified by Institution, if necessary to avoid the loss of
Intellectual Property Rights. In the event that deCODE notifies Institution
within such ninety (90) day period that it is not interested in acquiring the
benefits of Intellectual Property Rights to such Invention or Copyrightable
Work, or fails to notify Institution, in writing, within such period that it is
interested in acquiring the benefits of such Intellectual Property Rights, then
Institution at its own expense may file and maintain such Intellectual Property
Rights in any country where deCODE elects not to file. Such Intellectual
Property Rights shall not be included with the Intellectual Property Rights
licensed to deCODE pursuant to Sections 8.1 and 8.2 of this Agreement, and
Institution shall be free to license such Intellectual Property Rights to any
third party.
7.7 Institution Waives Filing. In the event that Institution does not
wish to file an application for Intellectual Property Rights with respect to a
particular Invention or Copyrightable Work made by Investigators, including any
Joint Invention or Joint Copyrightable Work, or does not wish to file such
applications with respect to specific countries, it shall first without delay
notify deCODE, and deCODE shall be free, where not contrary to United States
law, to file at its expense applications for such Intellectual Property Rights,
in the name of Institution if necessary. Institution shall render deCODE, at
deCODE's expense, all reasonable assistance in order to
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facilitate such filing. Any such application shall be considered an Intellectual
Property Right for all purposes of this Agreement.
7.8 deCODE Waives License. Notwithstanding any other provision of this
Agreement, once deCODE decides not to exercise its license rights to any
Intellectual Property Right and so notifies Institution, it shall have no
further obligation to reimburse Institution for any costs incurred or accrued
subsequent to Institution's receipt of such notice, associated with the
preparation, filing, prosecution, issuance, or maintenance of any such
application(s) or any Intellectual Property Right obtained therefrom, and
Institution shall have the right to license such Intellectual Property Right to
any third party.
7.9 Prosecution Notice. With respect to any Intellectual Property Right
covering a particular Invention or Copyrightable Work made by Investigators,
including any Joint Invention or Joint Copyrightable Work filed by mutual
agreement of the Parties, Institution shall use its best efforts to provide to
deCODE, sufficiently prior to the filing of such application, response or
request to allow for review and comment by deCODE, each application and
communication to and from the authorities which grant such Intellectual Property
Right, including without limitation each application, office action, response to
office action, request for terminal disclaimer, request for reissue or
reexamination of any patent issuing from such application, and notice of
interference or opposition. Institution shall give due consideration to any
comments made by deCODE or its patent counsel on any of the foregoing.
7.10 Confidentiality. All information given to deCODE by Institution in
accordance with this Section 7 shall be held in confidence by deCODE for so long
as such information remains unpublished.
8. Licensing of Intellectual Property.
8.1 Licensing Rights. Subject to the provisions of 35 U.S.C. Section
202-212, 64 F.R. Section 72,090 and 37 C.F.R. Section 401 et seq. and
regulations pertaining thereto, Institution hereby grants to deCODE an exclusive
option to obtain an exclusive, worldwide right and license, with a right to
grant sublicenses, under Institution's rights in Intellectual Property Rights,
as follows: (a) if in Patent Rights (i) to make, import, use and sell products,
and (ii) to use and sell methods, or (b) if in Copyrightable Works, to use and
sell such Copyrightable Work, including the right to incorporate such
Copyrightable Work into any product or service. The exclusive option granted to
deCODE to obtain license rights to Intellectual Property Rights shall extend for
a period of one hundred eighty (180) days after the date of deCODE's receipt of
written disclosure by the Institution of an Invention or Copyrightable Work,
including a Joint Invention or Joint Copyrightable Work, covered by
Institution's Intellectual Property Rights. In the event that deCODE fails to
exercise its option to take the exclusive license within the one hundred eighty
(180) day period, deCODE shall have no further rights to such Intellectual
Property Rights and Institution's obligations to deCODE under this Agreement
with regard to such Intellectual Property Rights shall terminate.
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8.2 License Terms. Upon the exercise of any option for an exclusive
license to any of Institution's Intellectual Property Rights by deCODE pursuant
to Section 8.1, deCODE and Institution shall enter into a License Agreement in
the form attached hereto as Appendix G. The royalty rate to be paid by deCODE to
Institution shall be determined by the Joint Steering Committee created by the
Strategic Alliance Agreement or, if the Joint Steering Committee is no longer in
existence, by mutual agreement of the Parties, based on the customary standards
in agreements between academia and industry for the Intellectual Property Rights
being licensed which take into account: (a) the type of product or services
which shall be developed using such Invention or Copyrightable Work (e.g., a
therapeutic product, diagnostic product, diagnostic service, research tool,
etc.); (b) whether products or services shall embody such Invention or
Copyrightable Work covered by such Intellectual Property Right; (c) the degree
to which products or services shall embody such Invention or Copyrightable Work
covered by such Intellectual Property Right; (d) the degree to which products or
services shall contain active components or technology not licensed from
Institution under this License Agreement; (e) whether the license is for an
Invention or Copyrightable Work owned solely by Institution, or is for a Joint
Invention or Joint Copyrightable Work; (f) the stage of development of the
product or service at the time of licensing, and the extent of the research and
development required to create a commercializable product or service; (g)
potential sales volume and profitability of the products or services; and (h)
projected expenses to develop and market the products or services. In the event
that the Joint Steering Committee, or the Parties, as the case may be, are not
able to reach resolution of the appropriate royalty rate within sixty (60) days
after deCODE exercises its option for a license for a particular Intellectual
Property Right, the Parties shall submit such matter to a "short-form"
arbitration proceeding, using "baseball" principles (in other words, each Party
shall submit a definitive position to the arbitrator(s), who shall be instructed
that such arbitrator(s) must select one of the positions submitted to represent
the final determination), to make a final determination. The arbitrator(s)
selected to conduct a "short-form" arbitration shall be knowledgeable and
experienced in the pharmaceutical industry.
8.3 Waiver of License Rights. The option to acquire a license to
Intellectual Property Rights hereunder shall not apply to any Intellectual
Property Right to which deCODE has waived its rights pursuant to Sections 7.6 or
7.8 of this Agreement.
8.4 Effect of License on Section 7. Upon the execution of a License
Agreement by the Parties with respect to any Invention or Copyrightable Work,
and any Intellectual Property Right covering such Invention or Copyrightable
Work, all rights and obligations of the Parties with respect to such
Intellectual Property Rights, including without limitation IP Costs, incurred on
or after the date of such execution, shall be governed by the terms of such
License Agreement.
8.5 Contractual Obligations to Other Sponsors. To the extent and only
to the extent that Institution is prohibited from granting to deCODE an
exclusive license to Institution's interest in any Patent Rights or
Copyrightable Work due to any contractual obligation of Institution requiring it
to license Institution's interest in such Patent Rights or Copyrightable Work to
any other sponsor of research (including, without limitation, any provider of
biological materials) with respect to an Invention made jointly by a person who
is not an Investigator but who is a co-inventor of a Patent Right or
Copyrightable Work with an Investigator, and provided that such
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other sponsor is bound by a provision similar to this Section 8.5 with respect
to such Patent Right or Copyrightable Work, then:
8.5.1 Any license granted to deCODE under a License Agreement
pursuant to this Agreement shall be co-exclusive with such other sponsor with
respect to such Patent Right or Copyrightable Work; and
8.5.2 Any royalty to be paid on products covered by such
Patent Right or Copyrightable Work shall be the lesser of: (a) [CONFIDENTIAL
TREATMENT REQUESTED]; or (b) [CONFIDENTIAL TREATMENT REQUESTED].
9. Indemnification and Disclaimer of Warranties.
9.1 Indemnification. Institution and deCODE shall each indemnify and
shall hold the other harmless for any injury to persons or damage to property to
the extent that such injury or damage is caused by the negligence or willful
misconduct of their employees or staff in carrying out their obligations under
this Agreement; provided, however, that deCODE shall defend, indemnify, and hold
harmless Institution and its trustees, employees and staff against any and all
actions, suits, claims, demands or prosecutions that may be brought or
instituted against Institution and/or its trustees, employees and staff based on
or arising out of or connected with deCODE's use of Institution Materials, or
the manufacture, use, sale or other distribution of any product by deCODE or its
licensees.
9.2 Disclaimer of Warranties. INSTITUTION MAKES NO WARRANTIES, EXPRESS
OR IMPLIED, AS TO THE RESULTS OF RESEARCH CONDUCTED UNDER THIS AGREEMENT OR AS
TO ANY MATERIAL, INVENTION, PATENT RIGHT, COPYRIGHTABLE WORK, OR PRODUCT
CONCEIVED, DISCOVERED, LICENSED, OR DEVELOPED UNDER THIS AGREEMENT, OR AS TO THE
OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH
OR ANY SUCH MATERIAL, INVENTION, PATENT RIGHT, COPYRIGHTABLE WORK OR PRODUCT.
INSTITUTION SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL OR OTHER DAMAGES SUFFERED
BY deCODE, ANY LICENSEE, OR ANY OTHERS RESULTING FROM SUCH RESEARCH OR FROM ANY
SUCH MATERIAL, INVENTION, PATENT RIGHT, COPYRIGHTABLE WORK, OR PRODUCT.
10. Use of Name.
No Party shall, without the prior written consent of the other Party,
use in endorsement, advertising, publicity, or otherwise, the name, trademark,
logo, symbol, or other image of the other Party or such Party's employees or
agents. Each Party agrees that its name may be used: (a) whenever required by
law or regulation, including without limitation disclosure to the Securities and
Exchange Commission, provided, however, that a Party using another Party's name
shall, to the extent reasonably practicable as solely determined by such using
Party, provide
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a copy of such proposed disclosure to such other Party in advance
and give consideration to such other Party's comments and requests regarding
such disclosure, but shall not be obligated to perform any act or omission in
response to such comments or requests; (b) by deCODE in connection with its
capital raising and financing purposes; (c) to make a joint, mutually agreeable
public announcement about the initiation of the relationship and the support of
the Research hereunder; and (d) to make routine acknowledgments of the
relationship, support of the Research hereunder and the basic substance of the
relationship, based upon standard agreed-to statements. If no such standard
statements have been established, then the disclosing Party shall provide the
non-disclosing Party with an opportunity to review, comment on and approve the
disclosure in advance of making such disclosure. Nothing in this Section 10
shall abridge any Party's rights with respect to use of the other Party's name
under the Strategic Alliance Agreement, the Crosswalk Development Agreement, or
any Software License Agreement.
11. Confidentiality.
11.1. Confidentiality Obligation. Except as otherwise provided in
Section 11.2, for a period of ten (10) years from the Effective Date, or, with
respect to deCODE Research Data set forth on Appendix E, such shorter time
period as the Parties and the Principal Investigator may agree to in writing,
each Party agrees to use all reasonable efforts, no less than those used to
protect its own confidential information, not to disclose to third parties any
Confidential Information disclosed to it by the other Party.
11.2 Permitted Disclosures. Nothing in this Agreement shall limit any
Party in any way from: (a) disclosure of information required by a public
authority; or (b) disclosure of information that is necessary to prevent
imminent danger to the public; provided, however, that in each case the
disclosing Party shall promptly inform the other Party of its intent to disclose
such information and the reasons for such disclosure.
11.3 Exceptions. The Party receiving Confidential Information shall
have no obligation of confidentiality with respect to any portion of such
Confidential Information which:
11.3.1 As of the Effective Date, is part of the public domain;
11.3.2 Subsequently becomes part of the public domain through
no fault of the receiving Party;
11.3.3 The receiving Party can show was in its possession, as
evidenced by written records kept in the ordinary course of business or by the
proof of actual use at the time of executing this Agreement, and which
information had not been wrongfully acquired, directly or indirectly, from the
disclosing Party;
11.3.4 Is subsequently disclosed to the receiving Party by a
third party not in violation of any right of, or obligation to, the disclosing
Party hereto;
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11.3.5 Is required to be disclosed by the receiving Party
under operation of law, provided that the receiving Party has given advance
notice of the proposed disclosure to the disclosing Party; or
11.3.6 Is developed by or on behalf of the receiving Party
without reference to the disclosing party's Confidential Information, as
evidenced by written records.
11.4 Injunction. In addition to any other right or remedy it may have
and without the posting of any bond or other security, each Party shall be
entitled to obtain injunctions to enjoin or restrain the other Party from any
violation or threatened violation of this Section 11.
12. Termination.
12.1 Breach by deCODE. If deCODE fails to meet any of its material
obligations under this Agreement and shall fail to remedy these failures within
sixty (60) days after receipt of written notice thereof, Institution shall have
the option of terminating this Agreement upon written notice thereof; provided,
however, that deCODE shall have the right to cure such default during such sixty
(60) day period. In the event of such a termination of this Agreement, deCODE
shall have no further option rights to any Intellectual Property Rights created
in the Research after the date of such termination.
12.2 Breach by Institution. If Institution fails to meet any of its
material obligations under this Agreement and shall fail to remedy these
failures within sixty (60) days after receipt of written notice thereof, deCODE
shall have the option of terminating this Agreement upon written notice thereof;
provided, however, that Institution shall have the right to cure such default
during such sixty (60) day period.
12.3 Termination by deCODE for Infeasibility. In the event that deCODE
determines that the Research is scientifically or economically not feasible or
no longer is consistent with deCODE's business strategy, deCODE may terminate
this Agreement at any time during the Performance Period by giving written
notice of termination to Institution ten (10) days prior to the effective date
of such termination.
12.4 Termination of Strategic Alliance Agreement. In the event that the
Strategic Alliance Agreement is terminated by deCODE pursuant to Section 10.5
thereof, and as a result thereof deCODE elects to terminate this Agreement
pursuant to Section 10.5 thereof, then this Agreement shall also be deemed to be
terminated ten (10) days after deCODE provides the Institution notice thereof as
provided in Section 10.5 of the Strategic Alliance Agreement. In the event that
the Strategic Alliance Agreement is terminated pursuant to Section 10.5, but
this Agreement is not terminated, then the JSC shall continue to exist for the
purposes provided in this Agreement, pursuant to the terms governing the JSC as
provided in the Strategic Alliance Agreement.
12.5 Effect of Termination.
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12.5.1 In the event that this Agreement is terminated by
Institution pursuant to Section 12.1, by deCODE pursuant to Sections 2.3 or 12.3
or by deCODE pursuant to Section 12.4 following a deCODE Notice under the
Strategic Alliance Agreement, the Institution shall use all reasonable efforts
to immediately commence winding down the Research and to terminate or cancel all
contractual commitments and other financial obligations as soon as possible to
avoid incurring additional expenses. deCODE shall reimburse Institution for
contractual commitments and financial obligations incurred by Institution during
the Performance Period if such financial obligations or contractual commitments
cannot reasonably be cancelled by Institution, and, in addition, shall reimburse
to Institution the direct salary costs incurred by Institution, for a period of
six months after the effective date of such termination, of any M.D. or Ph.D.
who, during the three (3) month period preceding the notice of termination, is
deriving fifty percent (50%) or more of his or her salary from the Research
funded by deCODE.
12.5.2 In the event that this Agreement is terminated by
deCODE pursuant to Section 12.2 or by deCODE pursuant to Section 12.4 following
an Institution Notice under the Strategic Alliance Agreement, all funding
obligations of deCODE shall cease as of the effective date of such termination.
12.6 Return of Confidential Information and Materials. In the event
that this Agreement is terminated by either Party pursuant to Section 2.3, 12.1,
12.2, 12.3 or 12.4, each Party shall return to the other its Confidential
Information and unused Materials and Patient Tissues, if any; provided, however,
that one copy of such other Party's Confidential Information may be retained for
such returning Party's legal archives.
13. Alternative Dispute Resolution.
13.1 Negotiation. The Parties shall attempt in good faith to resolve
through negotiation, any dispute, claim or controversy arising out of or
relating to this Agreement. Either Party may initiate negotiations by providing
written notice in letter form to the other Party, setting forth the subject of
the dispute and the relief requested. The recipient of such notice shall respond
within five (5) days with a written statement of its position on, and
recommended solution to, the dispute. If the dispute is not resolved by this
exchange of correspondence, then representatives of each Party with full
settlement authority shall meet at a mutually agreeable time and place within
ten (10) days of the date of the initial notice in order to exchange relevant
information and perspectives, and to attempt to resolve the dispute.
13.2 Arbitration. Except with respect to breaches for which a Party is
seeking injunctive relief, all disputes between the Parties relating to this
Agreement or the subject matter hereof which cannot be resolved by the Parties
according to Section 13.1, shall be submitted for final and binding arbitration
before JAMS/Endispute ("JAMS") pursuant to the United States Arbitration Act, 9
U.S.C. Section 1 et seq., and shall be held at a mutually agreeable location or
in New York City. Either Party may commence the arbitration process pursuant to
this Agreement by filing a written demand for arbitration with JAMS, with a copy
to the other Party. Unless the Parties otherwise agree in writing, the
arbitration shall be conducted in accordance with the provisions of JAMS
Comprehensive Arbitration Rules and Procedures in effect at the time of
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filing of the demand for arbitration, if the amount in controversy is greater
than $250,000, exclusive of interest; or, the arbitration shall be conducted in
accordance with the provisions of JAMS Streamlined Arbitration Rules and
Procedures in effect at the time of filing of the demand for arbitration, if the
amount in controversy is $250,000 or less, exclusive of interest. In the event
of a dispute over royalty rates, the arbitration shall be conducted as set forth
in Section 8.2. The Parties shall cooperate with JAMS and with one another in
selecting an arbitrator from JAMS' panel of neutrals, and in scheduling the
arbitration proceedings; provided however, that all arbitrators must be
knowledgeable in the pharmaceutical industry and must not be affiliated through
employment or otherwise with a competitor of either Party, as determined through
mutual assent of the Parties. The Parties shall participate in the arbitration
in good faith, and shall share equally in its costs. The provisions of this
Section may be enforced by any Court of competent jurisdiction, and the Party
seeking enforcement shall be entitled to an award of all costs, fees and
expenses, including attorneys fees, to be paid by the Party against whom
enforcement is ordered.
13.3 Injunction. This Section 13 shall not prohibit a Party from
seeking injunctive relief from a court of competent jurisdiction in the event of
a breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
14. Miscellaneous.
14.1 Governing Law. This Agreement shall be interpreted in accordance
with, and governed by, the laws of the State of Delaware, not including its
conflict of interest laws.
14.2 Independent Contractors. deCODE shall not have the right to direct
or control the activities of Institution or any Investigators in performing the
Research and Institution shall act hereunder only as an independent contractor;
nothing herein contained shall be construed to be inconsistent with that
relationship or status. Under no circumstances shall Institution or any
Investigator be considered to be an employee or agent of deCODE. This Agreement
shall not constitute, create, or in any way be interpreted as a joint venture,
partnership or formal business organization of any kind.
14.3 Assignment. Neither Party shall assign its rights or duties under
this Agreement to another without the prior express written consent of the other
Party, which consent shall not be unreasonably withheld; provided, however, that
either Party may assign this Agreement to a successor in ownership of all or
substantially all its business assets. Such successor shall expressly assume in
writing the obligation to perform in accordance with the terms and conditions of
this Agreement.
14.4 Notices. All notices, demands and other communications of every
kind and description whatsoever required or permitted under this Agreement shall
be in writing and shall be deemed to have been received when personally
delivered, or when shipped by private express carrier (signature required),
shipment charges prepaid, or when sent via facsimile transmission (receipt
verified) to the Party to whom delivery shall be made at the respective
addresses as set out below.
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If to Institution, to:
------------------------------------
Corporate Sponsored Research and Licensing
Attn: Director, Corporate Sponsored Research and Licensing
Institution Agreement #________
cc: Institution's representative on Joint Steering Committee
Telephone:
Facsimile:
If to deCODE, to:
deCODE genetics Ltd.
Xxxxxxxxx 0
XX-000 Xxxxxxxxx, Xxxxxxx
Attn:
Telephone: x000-000-0000
Facsimile: x000-000-0000
14.5 Modification. No modification or waiver of this Agreement or of
any covenant, condition, or limitation herein contained shall be valid unless in
writing and duly executed by both Parties.
14.6 Waiver. No waiver of any rights shall be effective unless assented
to in writing by the Party to be charged and the waiver of any breach or default
shall not constitute a waiver of any other right hereunder or any subsequent
breach or default.
14.7 Headings. The Section headings herein are for convenience only and
shall not affect the construction or interpretation of this Agreement.
14.8 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and effect
without said provision; provided however, that no such severability shall be
effective if the result of such action materially changes the economic benefit
of this Agreement to deCODE or to Institution.
14.9 Construction. The Parties have participated equally in the
creation of this Agreement; the language of this Agreement shall not be
presumptively construed against either Party.
14.10 Survival. The provisions of Sections 1, 3.3, 4, 5, 6, 7, 8, 9,
10, 11, 12.5, 12.6, 13, 14.1, 14.8, 14.9 and 14.10 shall survive any expiration
or termination of this Agreement.
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57
14.11 Counterparts. This Agreement may be executed in counterparts,
each of which shall constitute an original document, but all of which together
shall constitute one and the same instrument.
* * *
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In witness whereof, Institution and deCODE have caused this Agreement to be
executed by their duly authorized representatives as of the date first set forth
above.
INSTITUTION: DECODE GENETICS LTD.:
BY: ____________________________ BY: _________________________________
NAME: __________________________ NAME: _______________________________
TITLE: _________________________ TITLE: ______________________________
DATE: __________________________ DATE: _______________________________
Acknowledged and Agreed:
_________________________________ ____________________________________
Principal Investigator Date
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APPENDIX A
WORK PLAN
(see attached)
00
XXXXXXXX X
BUDGET
(see attached)
61
APPENDIX C
FORM OF TRANSFER LETTERS
(see attached)
62
TRANSFER LETTER
(Institution to deCODE)
Effective Date:__________________
This Transfer Letter confirms deCODE's desire to obtain Institution Materials,
subject to the terms and conditions of the Sponsored Research Agreement between
deCODE and Institution dated __________________.
Institution Materials to be transferred:
Institution Materials shall include any replicates, progeny, unmodified
derivatives and any parts of the foregoing incorporated in modifications. All
title and intellectual property rights in Institution Materials are and shall be
owned solely by Institution.
Proposed use of the Institution Materials listed above:
For Institution: Acknowledged by
Principal Investigator:
For deCODE:
Please send fully-executed original of this Transfer Letter, referencing
Agreement # XXXX, to: Corporate Sponsored Research and Licensing, [INSTITUTION
ADDRESS]
63
TRANSFER LETTER
(deCODE to Institution)
Effective date:_________________
This Transfer Letter confirms Institution's desire to obtain deCODE Materials,
subject to the terms and conditions of the Sponsored Research Agreement between
deCODE and Institution dated __________________.
deCODE Materials to be transferred:
deCODE Materials shall include any replicates, progeny, unmodified derivatives
and any parts of the foregoing incorporated in modifications. All title and
intellectual property rights in deCODE Materials are and shall be owned solely
by deCODE.
Permitted use of the deCODE Materials listed above:
For deCODE:
For Institution: Acknowledged by
Principal Investigator:
Please send fully-executed original of this Transfer Letter, referencing
Agreement # XXXX, to: Corporate Sponsored Research and Licensing, [INSTITUTION
ADDRESS]
64
APPENDIX D
FORM OF TRANSFER AGREEMENT FOR PATIENT TISSUE SAMPLES
65
TRANSFER AGREEMENT FOR PATIENT TISSUE SAMPLES
This Agreement is made as of xxxxxxxxxxxx between xxxxxxxxxxxxxx, a
corporation having a principal place of business at xxxxxxxxxxxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ("deCODE"), and [Partners Institution],
having a place of business at xxxxxxxxxxxxxxxxxxxx, ("Institution").
1. Institution shall make available to deCODE, through Dr. xxxxxxxxxxx
and other Institution personnel working under his or her direction
(collectively, the "Investigators"), the following patient tissue samples (the
"Samples"):
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
2. The Samples shall be used only under deCODE's immediate and direct
control for the internal, laboratory research purposes set forth below (the
"Project"):
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________. The
Samples shall not be used for any other purpose, including, without limitation,
in any research involving human subjects, in any product for commercial use or
distribution, or for the purpose of producing any product or for providing any
service, which product or service is sold or otherwise made commercially
available. No other right or license, to a patent or otherwise, is granted to
deCODE for the use of the Samples as a result of Institution's transmission of
them to deCODE.
3. It is understood that Investigators shall not provide to deCODE any
patient identifying information or "personal data" (as defined in Massachusetts
Law, c. 66A) including medical records and peer review data ("Information").
However, if in the course of this Agreement, deCODE is provided, obtains or has
access to such Information, deCODE shall return it immediately and shall not
use, publish or disclose such Information in any manner whatsoever. deCODE shall
comply with the laws and regulations of the Commonwealth of Massachusetts and
applicable federal laws and regulations relating to the confidentiality and
privacy of such Information. deCODE agrees to notify Institution and
Investigators orally and in writing within twenty-four (24) hours of its
discovery of any Information in its possession which is improperly used, copied,
or removed by anyone except an authorized representative of Institution or
deCODE. deCODE shall cooperate with Institution and Investigators in taking such
steps as are deemed appropriate by Institution to enjoin the misuse, regain
possession of the Information, and otherwise protect Institution's rights and
patients' privacy.
4. deCODE shall be responsible for all costs, insurance and liability
relating to processing and shipment of the Samples from Institution's place of
business, and for arranging for shipment if necessary.
66
5. The Samples are transferred AS IS, WITHOUT WARRANTY OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR ANY OTHER WARRANTY, INCLUDING SAFETY. THE SAMPLES HAVE NOT
BEEN ANALYZED OR TESTED BY INSTITUTION AND MAY, THEREFORE, CONTAIN VIRUSES,
BACTERIA OR OTHER POTENTIALLY DANGEROUS COMPONENTS. DECODE ACKNOWLEDGES AND
ACCEPTS THE RISKS OF SUCH VIRUSES, BACTERIA OR OTHER POTENTIALLY DANGEROUS
COMPONENTS. INSTITUTION MAKES NO REPRESENTATION OR WARRANTY THAT THE USE OF THE
SAMPLES WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
6. deCODE shall treat the Samples as infectious, biomedical and
biohazardous material, and shall abide by all federal, state and local laws and
regulations concerning their packaging, storage, labeling, handling, testing,
transportation, use and disposal.
7. Upon completion of the Project or upon termination of this Agreement
by either party for any reason upon 30 days' written notice to the other, deCODE
agrees to discontinue use of the Samples and to arrange for the return to
Institution or the lawful disposal (and provide written certification of same)
of all unused Samples in accordance with Paragraph 6.
8. Institution and deCODE shall each indemnify and shall hold the other
harmless for any injury to persons or damage to property to the extent that such
injury or damage is caused by the negligence or willful misconduct of their
employees or staff based on or arising out of the packaging, storage, labeling,
handling, testing, transfer, transportation, use or disposal of the Samples;
provided however, that deCODE shall defend, indemnify, and hold harmless
Institution and its trustees, employees and staff against any and all actions,
suits, claims, demands or prosecutions that may be brought or instituted against
Institution and/or its trustees, employees and staff based on or arising out of
or connected with deCODE's licensees' packaging, storage, labeling, handling,
testing, transfer, transportation, use or disposal of the Samples.
AGREED AND ACCEPTED:
deCODE [PARTNERS INSTITUTION]
By: _______________________ By: ___________________________
Title: _____________________ Title: ________________________
Date: _____________________ Date: _________________________
00
XXXXXXXX X
CONFIDENTIAL DECODE RESEARCH DATA
(to be updated from time to time)
List deCODE Research Data which the Parties and the Principal Investigator agree
are to be treated as deCODE's Confidential Information, in accordance with
Section 11 of this Agreement:
Term of confidentiality (check one):
___ Ten (10) years from the Effective Date; or
___ Until _____________________(event or date)
INSTITUTION: DECODE GENETICS LTD.:
BY: _____________________________ BY: _________________________________
NAME: ___________________________ NAME: _______________________________
TITLE: __________________________ TITLE: ______________________________
DATE:____________________________ DATE: ______________________________
Acknowledged and Agreed:
Principal Investigator: Date:
68
APPENDIX F
LIST OF INTELLECTUAL PROPERTY RIGHTS
(to be prepared and updated from time to time)
INSTITUTION: DECODE GENETICS LTD.:
BY: _____________________________ BY: _________________________________
NAME: ___________________________ NAME: _______________________________
TITLE: __________________________ TITLE: ______________________________
DATE:____________________________ DATE: ______________________________
69
APPENDIX G
FORM OF LICENSE AGREEMENT
(see attached)
70
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.]
LICENSE AGREEMENT
BETWEEN
[NAME OF INSTITUTION]
AND
DECODE GENETICS LTD.
DATED ____________, 2000
71
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement"), effective
______________ ___, 2000 (the "Effective Date") between [name of Partners'
Institution] ("Institution") (for example, The General Hospital Corporation
d.b.a. Massachusetts General Hospital, a Massachusetts not-for-profit
corporation having its principal offices at 00 Xxxxx Xxxxxx, Xxxxxx, XX 00000 or
The Xxxxxxx and Women's Hospital, Inc., a Massachusetts not-for-profit
corporation having its principal offices at 00 Xxxxxxx Xxxxxx, Xxxxxx, XX
00000), or Partners HealthCare System, Inc.) and deCODE genetics Ltd., an
Icelandic corporation which is a wholly-owned subsidiary of deCODE genetics,
Inc., a Delaware corporation, and having its principal offices at Xxxxxxxxx 0,
XX-000 Xxxxxxxxx, Xxxxxxx ("deCODE") (Institution and deCODE, each a "Party" and
collectively, the "Parties").
BACKGROUND
Under research programs funded by deCODE pursuant to that certain [SPONSORED
RESEARCH AGREEMENT, DATED AS OF ______________________, 2000 (THE "SPONSORED
RESEARCH AGREEMENT"), OR CLINICAL TRIAL AGREEMENT, DATED AS OF
______________________, 2000 (THE "CLINICAL TRIAL AGREEMENT")], the Institution
through research conducted by Dr. ______________________ has developed an
invention pertaining to ______. The Institution is preparing a U.S. Patent
Application covering said invention and all Dr. ______________________'s rights,
title and interest in said application have been assigned to Institution. As a
center for research and education, Institution is interested in licensing Patent
Rights and thus benefiting the public and the Institution by facilitating the
dissemination of the results of its research in the form of useful products, but
is without capacity to commercially develop, manufacture, and distribute any
such product. deCODE having such capacity, desires to commercially develop,
manufacture, use and distribute such products throughout the world.
The Parties have, therefore, agreed as follows:
1. Definitions.
1.1 "Accounting Period" shall mean each six-month period ending June 30
and December 31.
1.2 "Combined Product" shall have the meaning assigned to such term in
Section 5.5.
1.3 "Competitive" shall have the meaning assigned to such term in
Section 9.7.5.
1.4 "Costs" shall have the meaning assigned to such term in Section
4.1.
1.5 "Customer" shall have the meaning assigned to such term in Section
1.17.
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72
1.6 "deCODE" shall have the meaning assigned to such term in the
Introductory section.
1.7 "deCODE Indemnitees" shall have the meaning assigned to such term
in Section 8.1.2.
1.8 "Effective Date" shall have the meaning assigned to such term in
the Introductory section.
1.9 "First Commercial Sale" shall mean in each country the first sale
of any Product by deCODE or its Sublicensees.
1.10 "Indemnitee" shall have the meaning assigned to such term in
Section 8.1.3.
1.11 "Institution" shall have the meaning assigned to such term in the
Introductory Section.
1.12 "Institution Indemnitees" shall have the meaning assigned to such
term in Section 8.1.1.
1.13 "Inventors" shall mean those members of the Institution's
professional staff, graduate students, undergraduate students or employees of
Institution who contributed to the invention covered by the Patent Rights.
1.14 "JAMS" shall have the meaning assigned to such term in Section
11.2.
1.15 "Joint Patent Rights" shall have the meaning assigned to such term
in Section 4.5.
1.16 "License Field" shall mean.
1.17 [NOTE: THIS DEFINITION IS TO BE CUSTOMIZED BASED ON THE NATURE OF
THE LICENSED TECHNOLOGY AND LIKELY PRODUCTS OR SERVICES TO BE SOLD.] "Net Sales
Price" shall be with respect to any Product, the gross amount invoiced for such
Product by deCODE to Third Parties other than deCODE and its Sublicensees
("Customer"), less deductions for: (a) trade, quantity and/or cash discounts,
allowances and rebates (including, without limitation, promotional allowances or
discounts or similar allowances) actually allowed or given; (b) freight,
postage, shipping, insurance and transportation expenses and similar charges (in
each instance, if separately identified in such invoice); (c) credits or refunds
actually allowed for rejections, defects or recalls of such Product, outdated or
returned Product, or because of rebates or retroactive price reductions; and (d)
sales, value-added and excise taxes, tariffs and duties, and other taxes
directly related to the sale, to the extent that such items are included in the
gross invoice price (but not including taxes assessed against the income derived
from such sale). Such amounts shall be determined from the books and records of
deCODE, maintained in accordance with the reasonable accounting principles used
by such entity, consistently applied. Transfer of a Product within deCODE or
between deCODE and
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a Sublicensee for sale by the transferee shall not be considered a sale,
commercial use or disposition for the purpose of the foregoing Sections; in the
case of such transfer the Net Sales Price shall be based on sale of the Product
by the transferee.
1.18 "Party" or "Parties" shall have the meanings assigned to such
terms in the Introductory paragraph.
1.19 "Patent Rights" shall mean the U.S. Patent Application to be filed
by Dr. entitled , Serial No. ________________ or the equivalent of such
application, including any division, continuation or any corresponding foreign
patent application or Letters Patent or the equivalent thereof issuing thereon
or reissue, reexamination or extension thereof. Patent Rights shall also include
those claims in any continuation-in-part of the aforementioned patent
application which claim an invention described or claimed in patent application
Serial No._________________.
1.20 "Product" shall mean any method, procedure, product, or component
part thereof whose manufacture, sale, importation, or use includes any use of
Technological Information that is covered by any Valid Claim included in the
Patent Rights.
1.21 "Sublicensee" shall mean any Third Party licensed by deCODE to
make, have made, use or sell any Product. As used in this Agreement,
"Sublicensee" shall include any Third Party to whom deCODE has granted, directly
or indirectly, the right to distribute a Product, provided that such Third Party
has the responsibility in whole or in part for marketing and/or promotion of the
Product within the territory for which such distribution rights are granted.
1.22 "Sublicensing Income" shall have the meaning assigned to such term
in Section 5.3.
1.23 "Technological Information" shall mean any unpublished research
and development information, unpatented inventions, and unpublished clinical
data and technical data known to the Inventors in the possession of the
Institution prior to the Effective Date which relates to and is necessary for
the practice of the inventions claimed in the Patent Rights and which the
Institution is not prohibited from disclosing to deCODE pursuant to the
agreement under which such information or data was created.
1.24 "Third Party" shall mean any party other than a Party.
1.25 "Valid Claim" shall mean either: (a) a claim of an issued and
unexpired patent included in the Patent Rights, which has not been held
permanently revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, which decision is unappealable or
unappealed within the time allowed for appeal, and which claim has not been
admitted to be invalid or unenforceable through reissue or disclaimer or
otherwise; or (b) a pending claim of a pending patent application that is
classified under this Agreement as a Patent Right, which claim (i) was filed in
good faith, (ii) is reasonably likely to issue, (iii) has not been
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abandoned or finally disallowed without the possibility of appeal or refining of
said application, and (iv) has not been pending for a period in excess of five
(5) years from the earliest date from which the patent application was filed or
claims priority in such country unless such application is the subject of an
appeal, interference or opposition being prosecuted with the consent of deCODE.
2. License.
2.1 Grant. Institution hereby grants deCODE, subject to the terms and
conditions of this Agreement:
2.1.1 The exclusive (even as to Institution), worldwide right
and license, under the Patent Rights, to develop, make, have made, use, import,
export, lease, offer to sell, sell, have sold and otherwise exploit Products in
the License Field, and to grant, offer for sale and authorize sublicenses with
respect to the right and license granted under this Section 2.1.1 to Third
Parties; and
2.1.2 A non-exclusive perpetual license, with the right to
sublicense, to use Technological Information for any purpose that does not
infringe any patent owned, in whole or in part, by Institution that is not
expressly licensed to deCODE.
2.2 Exceptions. It is understood that the granting of any exclusive
license hereunder is subject to Institution's right to make and to use the
subject matter described and claimed in any Patent Rights for non-commercial
internal research, clinical and educational purposes, but not for any commercial
or other non-commercial purpose, and that if federal funding supported such
Patent Rights, deCODE's license will be subject to the rights, conditions and
limitations imposed by U.S. law, including without limitation the royalty-free
non-exclusive license granted to the U.S. government (see 35 U.S.C. Section 202
et seq. and regulations pertaining thereto; see also Principles and Guidelines
for Sharing of Biomedical Research Resources, 64 F.R. 72,090 and FARS 27.4).
2.3 Disclosure of Technological Information. Within thirty (30) days of
the Effective Date, upon request by deCODE, Institution shall disclose
Technological Information to deCODE.
2.4 Off-Label Usage. In the event that, at any time during the term of
this Agreement, Institution intends to offer to a Third Party any rights in any
Patent Rights or Technological Information outside of the Licensed Field or
receives an offer from a Third Party to acquire any such rights, Institution
shall notify deCODE of such offer. deCODE shall have sixty (60) days from
receipt of such notification to determine in good faith whether the grant of
such rights presents a reasonable risk of off-label usage in the Licensed Field
in which deCODE is developing, or has developed, a Product. In the event that
deCODE determines in good faith that the grant of such rights presents a
reasonable risk of off-label usage in the Licensed Field in which deCODE is
developing, or has developed, a Product, it shall have the right of first
refusal to accept such rights on terms no less favorable to Institution than
those last offered by such Third Party. In the event that deCODE desires to
exercise its right to acquire such rights, it shall notify Institution of its
determination within such sixty (60) day period, whereupon Institution shall
grant
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75
such rights to deCODE on terms no less favorable to Institution than those last
offered by such Third Party, and shall not grant such rights to the Third Party.
In the event that deCODE determines that the offer does not present a reasonable
risk of such off-label usage, or fails to notify Institution of its
determination to acquire such rights within the sixty (60) day period,
Institution shall have the unrestricted right to grant such rights to such Third
Party. In the event that deCODE determines that the offer does present a
reasonable risk of such off-label usage, but the Parties fail to reach a
mutually acceptable agreement for deCODE to acquire such rights within the sixty
(60) day period, the Parties shall negotiate the terms of a mechanism to
compensate deCODE for such off-label usage and Institution shall have the right
to grant such rights to such Third Party, subject to such compensation
mechanism.
2.5 Construction of Grant. It is understood that nothing herein shall
be construed to grant deCODE a license express or implied under any patent owned
solely or jointly by Institution other than the Patent Rights expressly licensed
hereunder.
3. Due Diligence Obligations.
3.1 Commercialization. deCODE shall itself, or through its
Sublicensees, use commercially reasonable efforts to develop and make
commercially available Products for commercial sales and distribution throughout
the world in the License Field.
[3.2 DILIGENCE MILESTONES. IN THE CASE OF DECODE, THE COMMERCIALIZATION
EFFORTS TO BE MADE PURSUANT TO SECTION 3.1 SHALL CONSIST OF ACHIEVING THE
FOLLOWING OBJECTIVES WITHIN THE TIME PERIOD DESIGNATED BELOW FOLLOWING THE
EFFECTIVE DATE:
3.2.1 WITHIN ______________________( ) YEARS, [CONFIDENTIAL TREATMENT
REQUESTED]
3.2.2 WITHIN ______________________( ) YEARS, [CONFIDENTIAL TREATMENT
REQUESTED]; AND
3.2.3 WITHIN ______________________( ) YEARS, [CONFIDENTIAL TREATMENT
REQUESTED]; OR
3.2.4 SUCH OTHER MILESTONES AS THE PARTIES AGREE ARE APPROPRIATE FOR
THE PARTICULAR PRODUCT.
PROVIDED, HOWEVER, THAT INSTITUTION SHALL NOT UNREASONABLY WITHHOLD ITS CONSENT
TO ANY REVISION IN SUCH TIME PERIODS WHENEVER REQUESTED IN WRITING BY DECODE AND
SUPPORTED BY EVIDENCE OF TECHNICAL DIFFICULTIES OR DELAYS IN CLINICAL STUDIES OR
REGULATORY PROCESSES THAT THE PARTIES COULD NOT HAVE REASONABLY AVOIDED. FAILURE
TO ACHIEVE ONE OR MORE OF THE ABOVE OBJECTIVES WITHIN THE ABOVE STATED TIME
PERIODS OR WITHIN ANY EXTENSION GRANTED BY INSTITUTION SHALL RESULT IN
INSTITUTION HAVING THE RIGHT TO CANCEL UPON THIRTY (30) DAYS NOTICE ANY
EXCLUSIVE LICENSE GRANTED HEREUNDER.
OR, IN LIEU OF MILESTONES, THE PARTIES MAY AGREE TO PROVIDE:
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3.2 ANNUAL MINIMUM ROYALTIES. IN THE CASE OF DECODE, THE
COMMERCIALIZATION EFFORTS TO BE MADE PURSUANT TO SECTION 3.1 SHALL BE DEEMED TO
BE SATISFIED IF DECODE PAYS TO THE INSTITUTION ANNUAL MINIMUM ROYALTIES OF
$________ DURING EACH CALENDAR YEAR PURSUANT TO SECTION 5.1 OR, IF SUCH AMOUNT
HAS NOT BEEN PAID PURSUANT TO SECTION 5.1, THEN IF DECODE PAYS ANY SHORTFALL TO
INSTITUTION WITHIN SIXTY (60) DAYS AFTER THE END OF SUCH CALENDAR YEAR.]
3.3 Commercialization by Certain Sublicensees. deCODE shall be deemed
to have complied with all requirements of Section 3.2 if deCODE grants a
sublicense to a Sublicensee who is pharmaceutical company with a market
capitalization/net assets in excess of [CONFIDENTIAL TREATMENT REQUESTED] and
who has agreed in writing to use reasonable commercial efforts to develop,
market and sell Products in the License Field or meets such other criteria as
the Parties agree are acceptable.
3.4 Progress Reports. At intervals no longer than once every twelve
(12) months, deCODE shall provide a written summary report to Institution on
progress made toward the foregoing objectives.
4. Filing, Prosecution and Maintenance of Patent Rights.
4.1 Duties and Costs. Subject to Section 4.3 and 4.4, Institution shall
be responsible for the preparation, filing, prosecution and maintenance of all
patent applications and patents included in Patent Rights. deCODE shall
reimburse Institution for all reasonable costs ("Costs") incurred by Institution
for the preparation, filing, prosecution and maintenance of all Patent Rights as
follows:
4.1.1 Subject to Sections 4.3 and 4.6, for all Costs incurred
by Institution from and after the Effective Date, deCODE shall reimburse
Institution upon receipt of invoices from Institution; and
4.1.2 For all Costs incurred by Institution prior to the
Effective Date, which have not been previously reimbursed by deCODE, deCODE
shall reimburse Institution within ten (10) days after receipt of invoices
therefor following execution of this Agreement.
4.2 deCODE's Interests. With respect to any Patent Right, each document
or a draft thereof pertaining to the filing, prosecution, or maintenance of such
Patent Right pursuant to Section 4.1, including but not limited to each patent
application, office action, response to office action, request for terminal
disclaimer, and request for reissue or reexamination of any patent issuing from
such application shall be provided to deCODE as follows. Documents received from
any patent office or counsel's analysis thereof shall be provided promptly after
receipt. For a document to be filed in any patent office, a draft of such
document shall be provided sufficiently prior to its filing, to allow for review
and comment by the deCODE. With respect to any proposed filings to be made to
any patent office for the Patent Rights, Institution shall consult with deCODE,
shall in good faith consider and give due respect to deCODE's position, and
shall
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where practicable and not contrary to state or federal regulations or
Institution's policies, act in deCODE's best interests with respect thereto.
4.3 Abandonment by deCODE. If at any time during any such preparation,
filing, prosecution or maintenance action, deCODE shall elect not to pay or
continue to pay the Costs for such Patent Right, deCODE shall so notify
Institution in writing of its election and deCODE shall thereafter be relieved
of the obligation to pay any additional Costs regarding such Patent Right
incurred after the receipt of such notice by Institution. Such U.S. or foreign
patent application or patent shall thereupon cease to be a Patent Right
hereunder and Institution shall be free to license its rights to that particular
U.S. or foreign patent application or patent to any other person on any terms.
4.4 Abandonment by Institution. In the event that Institution does not
wish to prepare, file, prosecute or maintain, as the case may be, any Patent
Rights, it shall first without delay notify deCODE, and deCODE, at its own
expense, and shall be free, where not contrary to United States law, to prepare,
file, prosecute or maintain, as the case may be, such patent applications or
patents. Institution shall render deCODE, at deCODE's expense, all reasonable
assistance in order to facilitate such action. Any such patent application or
patent shall be considered a Patent Right for all purposes of this Agreement.
4.5 Joint Patent Rights. deCODE, at its sole expense, shall be
responsible for the preparation, filing, prosecution and maintenance of all
patent applications and patents jointly owned by deCODE and Institution ("Joint
Patent Rights") included in Patent Rights. Institution shall render deCODE, at
deCODE's expense, all reasonable assistance in order to facilitate such action.
Any such Joint Patent Right shall be considered a Patent Right for all purposes
of this Agreement, provided that for any such Joint Patent Right, each document
or a draft thereof pertaining to the filing, prosecution, or maintenance of such
Joint Patent Right pursuant to this Section 4.5, including but not limited to
each patent application, office action, response to office action, request for
terminal disclaimer, and request for reissue or reexamination of any patent
issuing from such application shall be provided to Institution as follows.
Documents received from any patent office or counsel's analysis thereof shall be
provided promptly after receipt. A draft of any document to be filed with any
patent office shall be provided sufficiently prior to its filing to allow for
review and comment by Institution, if reasonably practicable. Notwithstanding,
with respect to any proposed filings to be made to any patent office for the
Patent Rights, deCODE shall consult with Institution and shall in good faith
consider and give due respect to Institution's position. In the event that such
Joint Patent Right claims a "subject invention" as defined by 35 U.S.C. Section
201, deCODE shall comply with 35 U.S.C. Sections 200 et seq. and the
applicable regulations in the filing, prosecution, maintenance and sublicensing
of such Joint Patent Right.
4.6 deCODE's Abandonment of Joint Patent Rights. In the event that
deCODE does not wish to prepare, file, prosecute or maintain, as the case may
be, any of the Joint Patent Rights, it shall first without delay notify
Institution, and Institution, at its own expense, shall be free, where not
contrary to United States law to prepare, file, prosecute or maintain, as the
case may be, such Joint Patent Right. deCODE shall render Institution, at
Institution's expense, all
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reasonable assistance in order to facilitate such action. Any such Joint Patent
Right shall thereupon cease to be a Patent Right hereunder and Institution shall
be free to license its rights to that particular joint patent application or
joint patent to any Third Party on any terms.
5. Royalties and Milestone Payments.
5.1 Royalties. deCODE shall pay Institution royalties in accordance
with the following schedule, such undertaking and schedule having been agreed to
for the purpose of reflecting and advancing the mutual convenience of the
Parties, beginning with the First Commercial Sale in any country.
5.1.1 On all sales of a Product by deCODE, ____ percent ( %)
of the Net Sales Price so long as the manufacture, use importation or sale of
such Product is covered by a Valid Claim of any Patent Rights licensed
exclusively to deCODE.
5.1.2 There shall be no royalties due by deCODE to Institution
on any sales of a Product which is not covered by a Valid Claim of any Patent
Right.
5.2 Royalty Obligation. Only one royalty under Section 5.1 shall be due
and payable to Institution by deCODE for any Product regardless of the number of
Patent Rights or amount of Technological Information covering such Product.
5.3 Sublicense Royalties. deCODE shall pay Institution ______ percent
(__%) of all Sublicensing Income received by deCODE from its Sublicensees with
respect to the sale of Products by such Sublicensee. "Sublicensing Income" shall
mean all monetary consideration or consideration paid in equity, including, for
example, up-front payments, milestones, royalties, and stock or other forms of
equity received by deCODE from its Sublicensees with respect to the Products,
but excluding any amounts received by deCODE in consideration for (a) equity,
(b) debt, (c) research and development expenses, (d) amounts received for the
license or sublicense of (i) any intellectual property other than the Patent
Rights, or (ii) any products other than the Products, (e) rights or benefits
unrelated to the Products or related to other services being provided by deCODE
to such Sublicensee, or (f) reimbursement for patent or other expenses. In the
event that a sublicense of Products is being granted by deCODE together with
other products, deCODE shall make a good faith allocation of the amount of
consideration being made with respect to Products.
5.4 Milestone Payments. In addition to the payments provided for in
Sections 5.1, 5.2 and 5.3, deCODE shall pay Institution the following amounts
upon the occurrence of the following events:
5.4.1 $_____________ upon execution of this Agreement;
5.4.2 $_____________ upon [CONFIDENTIAL TREATMENT REQUESTED];
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5.4.3 $_____________ upon [CONFIDENTIAL TREATMENT REQUESTED].
5.5 Royalties of Combined Products. Where a Product is sold in
combination with one or more other products that are not Products (the "Combined
Product"), deCODE shall pay royalties to Institution based upon the value of the
Combined Product attributable to the Patent Rights. The Parties agree to
negotiate in good faith to reach a mutual agreement concerning the value of
Combined Product attributable to such Patent Rights or Technological
Information.
5.6 Third Party Royalties. In the event that deCODE is required to pay
royalties to one or more Third Parties for the license of technology other than
the Patent Rights or the Technological Information in order to make, use or sell
a Product, then deCODE shall be entitled to reduce its royalty obligation, on a
country by country basis, pursuant to Sections 5.1 and 5.5 by [CONFIDENTIAL
TREATMENT REQUESTED] of the aggregate amount due to such Third Parties, but in
no event shall such reduction exceed [CONFIDENTIAL TREATMENT REQUESTED] of the
royalties otherwise due to Institution under this Agreement.
5.7 Royalty Reduction. In the event that the royalty paid to
Institution is a significant factor in the return realized by deCODE so as to
diminish deCODE's capability to respond to competitive pressures in the market,
Institution agrees to consider a reasonable reduction in the royalty paid to
Institution as to each such Product for the period during which such market
condition exists. Factors determining the size of the reduction will include
profit margin on such Product and on analogous products, prices of competitive
products, total prior sales by deCODE, and deCODE's expenditures in Product
development.
5.8 Past Due Payments. The payments due under this Agreement shall, if
past due, bear interest until payment is made at a per annum rate equal to
[CONFIDENTIAL TREATMENT REQUESTED] above the prime rate in effect at the Bank of
Boston on the due date, not to exceed the maximum permitted by law. The payment
of such interest shall not preclude Institution from exercising any other rights
it may have as a consequence of the lateness of any payment.
6. Reports and Payments.
6.1 Record Keeping. deCODE shall keep, and shall cause each of its
Sublicensees, if any, to keep full and accurate books of accounts in sufficient
detail to allow Institution or its designee to confirm the accuracy of amounts
payable to Institution under this Agreement. Such books of account shall be kept
at deCODE's or such Sublicensee's principal place of business, as the case may
be. The keeper of such books of account shall maintain books covering each
Accounting Period for the three (3) years following the end of such Accounting
Period and shall permit Institution or its designee, at Institution's expense,
to inspect such books of accounts during reasonable business hours for the
purpose of verifying royalty statements or compliance with this Agreement.
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6.2 Payment Form and Date. In each year the amount of royalty due shall
be calculated semiannually as of the end of each Accounting Period and shall be
paid semiannually within the sixty (60) days next following such date, every
such payment to be made in United States currency and to be supported by the
accounting method prescribed in Section 6.3, or in the case of deCODE's
Sublicensee, according to such other reasonable accounting method used by such
Sublicensee. Whenever conversion from any foreign currency shall be required,
such conversion shall be at the rate of exchange thereafter published in The
Wall Street Journal for the last business day of the applicable Accounting
Period.
6.3 Payment Reports. With each semiannual payment, deCODE shall deliver
to Institution a full and accurate accounting to include at least the following
information:
6.3.1 Quantity of each Product sold or leased (by country) by
deCODE, and its Sublicensees;
6.3.2 Total xxxxxxxx for each Product (by country);
6.3.3 Quantities of each Product used by deCODE and its
Sublicensees;
6.3.4 Names and addresses of all Sublicensees of deCODE; and
6.3.5 Total royalties payable to Institution.
7. Infringement.
7.1 Right of Institution. If either Party learns of an infringement or
other use, rights or ownership claim or threatened infringement or other such
claim by a Third Party with respect to any Patent Rights, such Party shall
promptly notify the other Party and shall provide such other Party with
available evidence of such infringement, whereupon Institution shall have the
first right, but not the duty, to institute at its sole cost and expense,
actions against Third Parties based on any Patent Rights under this Agreement.
7.2 Right of deCODE. In the event that Institution does not institute
an infringement proceeding against an offending Third Party within ninety (90)
days after obtaining knowledge of such alleged infringement or misappropriation,
deCODE shall have the right, but not the duty, to institute at its sole cost and
expense, an action to enforce such Patent Rights with respect to any
infringement or misappropriation by a Third Party.
7.3 Cooperation and Expenses. In the event one Party shall initiate or
carry on legal proceedings to enforce any Patent Rights against any alleged
infringer, the other Party shall fully cooperate with and supply all assistance
reasonably requested by the Party initiating or carrying on such proceedings.
The Party which institutes any suit to protect or enforce a Patent Right shall
have sole control of that suit and shall bear the reasonable expenses (excluding
legal fees) incurred by said other Party in providing such assistance and
cooperation as is requested pursuant
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to this Section. If the Parties elect to cooperate in instituting and
maintaining such action, such costs and expenses shall be borne by the Parties
in such proportions as they may agree in writing.
7.4 Execution of Documents and Other Acts. Each Party shall execute all
necessary and proper documents, take such actions as shall be appropriate to
allow the other Party to institute and prosecute such infringement actions and
shall otherwise cooperate in the institution and prosecution of such actions
(including, without limitation, consenting to being named as a nominal party
thereto).
7.5 Enforcement Award. Any award paid by Third Parties as a result of
such an infringement action (whether by way of settlement or otherwise) shall be
applied first to reimburse both Parties for all costs and expenses incurred by
the Parties with respect to such action on a pro rata basis and, if after such
reimbursement any funds shall remain from such award, they shall be allocated as
follows:
7.5.1 [CONFIDENTIAL TREATMENT REQUESTED];
7.5.2 [CONFIDENTIAL TREATMENT REQUESTED] ; or
7.5.3 If the Parties have cooperated in instituting and maintaining
such action, the Parties shall allocate such remaining funds between themselves
in the same proportion as they have agreed to bear the expenses of instituting
and maintaining such action.
7.6 Infringement Actions by Third Parties. In the event of the
institution of any suit by a Third Party against deCODE for patent infringement
which dominates the Patent Rights and involves the manufacture, sale,
distribution or marketing of any Product, and such suit is not covered by the
indemnification provided pursuant to Section 8.1.2, deCODE shall have the right
to defend such suit at its own expense, and Institution hereby agrees to assist
and cooperate with deCODE, at deCODE's expense, to the extent necessary in the
defense of such suit. During the pendency of any such action, deCODE shall
continue to make all payments due under this Agreement; provided, however, that
deCODE shall be entitled to a credit against such payments of an amount equal to
one-half of the reasonable costs actually incurred in such action.
7.7 Infringement Award in deCODE's Favor in Actions by Third Parties.
If deCODE finally prevails and receives an award from such Third Party as a
result of such action (whether by way of judgment, award, decree, settlement or
otherwise), such award shall be allocated, first, to deCODE and Institution to
reimburse each Party for its pro rata share of costs and expenses incurred in
such action, and the remaining amount shall be [CONFIDENTIAL TREATMENT
REQUESTED].
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7.8 Infringement Award Against deCODE in Actions by Third Parties. If
deCODE finally loses, whether by judgment, award, decree, settlement or
otherwise), and is required to pay a royalty or damages to such Third Party in
order to make, use, have made or import a Product, deCODE shall continue to pay
the royalties for such Product in the countries which are the subject of such
action, but shall be entitled to a credit against such payments in an amount
equal to the royalty or damages paid to such Third Party under the terms set
forth in Section 5.6.
7.9 Right to Terminate Agreement. If deCODE is required to pay a
royalty or damages to a Third Party pursuant to Section 7.8 and the amount of
such royalty or damages exceeds [CONFIDENTIAL TREATMENT REQUESTED] of the
royalties due hereunder for such Product in such country(ies), deCODE shall have
the right to terminate this Agreement solely with respect to such Product in
such country(ies).
8. Indemnification and Insurance.
8.1 Indemnification.
8.1.1 deCODE shall indemnify, defend and hold harmless
Institution and its trustees, officers, medical and professional staff,
employees, and agents and their respective successors, heirs and assigns (the
"Institution Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorney's fees and expenses of litigation) incurred by or
imposed upon the Institution Indemnitees or any one of them in connection with
any claims, suits, actions, demands or judgments of a Third Party to the extent
arising out of any theory of product liability (including, but not limited to,
actions in the form of tort, warranty, or strict liability) concerning any
product, process or service made, used or sold pursuant to any right or license
granted under this Agreement; and shall, at deCODE's own expense provide
attorneys reasonably acceptable to Institution to defend against any actions
brought or filed against such Institution Indemnitee whether or not such actions
are rightfully brought. deCODE's indemnification under this Section 8.1.1 shall
not apply to any liability, damage, loss or expense to the extent that it is
directly attributable to the negligent activities, reckless misconduct or
intentional misconduct of the Institution Indemnitees.
8.1.2 Institution shall indemnify, defend and hold harmless
deCODE and its directors, officers, professional staff, employees, and agents
and their respective successors, heirs and assigns (the "deCODE Indemnitees"),
against any liability, damage, loss or expense (including reasonable attorney's
fees and expenses of litigation) incurred by or imposed upon the deCODE
Indemnitees or any one of them in connection with any claims, suits, actions,
demands or judgments of a Third Party to the extent arising out of any breach of
the Institution's representations and warranties set forth in Section 10; and
shall, at Institution's own expense provide attorneys reasonably acceptable to
deCODE to defend against any actions brought or filed against such deCODE
Indemnitee whether or not such actions are rightfully brought.
8.1.3 In the event that any Institution Indemnitee or deCODE
Indemnitee (an "Indemnitee") entitled to indemnification under Section 8.1.1 or
8.1.2 is seeking such indemnification, such Indemnitee shall inform the
indemnifying Party of the claim as soon as
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reasonably practicable after such Indemnitee receives notice of such claim,
shall permit the indemnifying Party to assume direction and control of the
defense of the claim (including the sole right to settle it at the sole
discretion of the indemnifying Party, provided that such settlement does not
impose any obligation on, or otherwise adversely affect, the Indemnitee or the
other Party) and shall cooperate as requested (at the expense of the
indemnifying Party) in the defense of the claim. As the Parties intend complete
indemnification, all costs and expenses incurred by an Indemnitee in connection
with enforcement of Section 8.1.1 or 8.1.2 shall also be reimbursed by the
indemnifying Party.
8.1.4 This Section 8.1 shall survive expiration or termination
of this Agreement.
8.2 Insurance.
8.2.1 Beginning at such time as any Product is being
commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by deCODE or by a Sublicensee agent of deCODE, deCODE
shall, at its sole cost and expense, procure and maintain commercial liability
insurance in amounts not less than [CONFIDENTIAL TREATMENT REQUESTED] per
incident and [CONFIDENTIAL TREATMENT REQUESTED] annual aggregate and naming the
Institution Indemnitees as additional insureds. Such commercial liability
insurance shall provide (i) product liability coverage and (ii) broad form
contractual liability coverage for deCODE's indemnification under Section 8.1 of
this Agreement. If deCODE elects to self-insure all or part of the limits
described above (including deductibles or retentions which are in excess of
[CONFIDENTIAL TREATMENT REQUESTED] annual aggregate) such self-insurance program
must be acceptable to the Institution and the Risk Management Foundation. In the
event deCODE's Sublicensees elect to self-insure all or part of such limits,
such self-insurance program shall be deemed acceptable to the Risk Management
Foundation. The minimum amounts of insurance coverage required under this
Section 8.2.1 shall not be construed to create a limit of deCODE's liability
with respect to its indemnification under Section 8.1 of this Agreement.
8.2.2 deCODE shall provide Institution with written evidence
of such insurance upon request of Institution. deCODE shall provide Institution
with written notice at least fifteen (15) days prior to the cancellation,
non-renewal or material change in such insurance; if deCODE does not obtain
replacement insurance providing comparable coverage prior to the expiration of
such fifteen (15) day period, Institution shall have the right to terminate this
Agreement effective at the end of such fifteen (15) day period without notice or
any additional waiting periods.
8.2.3 deCODE shall maintain such commercial institution
liability insurance beyond the expiration or termination of this Agreement
during: (a) the period that any Product is being commercially distributed or
sold (other than for the purpose of obtaining regulatory approvals) by deCODE or
by a Sublicensee or agent of deCODE; and (b) a reasonable period after the
period referred to in Section 8.2.3(a), which in no event shall be less than
[CONFIDENTIAL TREATMENT REQUESTED].
8.2.4 This Section 8.2 shall survive expiration or termination
of this Agreement.
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8.3 Disclaimer. OTHER THAN THE REPRESENTATIONS AND WARRANTIES SET FORTH
UNDER THIS AGREEMENT, INSTITUTION MAKES NO WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR ANY
IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT,
TRADEMARK, SOFTWARE, TRADE SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR
DATA LICENSED OR OTHERWISE PROVIDED TO deCODE HEREUNDER AND HEREBY DISCLAIMS THE
SAME.
9. Termination.
9.1 Term. This Agreement shall commence as of the Effective Date of
this Agreement and, unless sooner terminated as provided hereunder, shall
terminate as follows:
9.1.1 As to each Product, this Agreement shall terminate upon the
later of: (a) 15 years from the Effective Date of this Agreement; (b) the
expiration of the last to expire of the Patent Rights necessary for the
manufacture, use and sale of such Product in such country; or (c) 5 years after
the First Commercial Sale of such Product in such country.
9.1.2 This Agreement shall terminate in its entirety upon its
termination as to all Products.
9.2 Termination by deCODE. deCODE shall have the right to terminate the
licenses granted herein, in whole or as to any Product in any country, at any
time, and from time to time, by giving notice in writing to Institution. Such
termination shall be effective sixty (60) days from the date such notice is
given, and all deCODE's rights associated therewith shall cease as of that date,
subject to Sections 9.5, 11 and 12.
9.3 Termination by Institution. Institution shall have the right to
terminate the licenses granted herein, as to any Product in any country, upon
written notice to deCODE in the event that after the First Commercial Sale of
such Product in such country there is a continuous one (1) year period in which
no Product is sold in such country, provided such sale is not prevented by force
majeure, government regulation or intervention, or institution of a law suit by
any Third Party. Such termination shall be effective sixty (60) days from the
date such notice is given, and all deCODE's rights associated therewith shall
cease as of that date, subject to Sections 9.5, 11 and 12.
9.4 Default; Notice; Cure. If either party shall fail to faithfully
perform any of its obligations under this Agreement except the due diligence
milestones specified in Section 3 herein, the nondefaulting Party may give
written notice of the default to the defaulting Party. Unless such default is
corrected within sixty (60) days after such notice, the notifying Party may
terminate this Agreement and the license hereunder upon sixty (60) days prior
written notice, provided that only three such sixty (60) day grace periods shall
be available in any twelve (12) month period with respect to a default of any
particular provision hereunder. Thereafter notice of default of said provision
shall constitute termination.
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9.5 Disposal of Inventory. Upon the termination of any license granted
herein, in whole or as to any Product for any reason other than a failure to
cure a material breach of the Agreement by deCODE, deCODE shall have the right
for one year or such longer period as the Parties may reasonably agree to
dispose of all Product or substantially completed then on hand to which such
termination applies, and royalties shall be paid to Institution with respect to
such Product as though this Agreement had not terminated.
9.6 Rights following Expiration or Termination.
9.6.1 Following expiration of this Agreement as to each Product
pursuant to Section 9.1.1, deCODE shall have the royalty-free non-exclusive
right within the License Fields to continue to use such Product as heretofore
licensed.
9.6.2 Following expiration of this Agreement in its entirety
pursuant to Section 9.1.2 or termination by deCODE pursuant to Section 9.4,
deCODE shall have the royalty-free non-exclusive right within the License Fields
to continue to use such Product as heretofore licensed.
9.6.3 Upon termination of this Agreement as to any Product in any
country by Institution pursuant to Section 9.3: (i) deCODE shall promptly
transfer to Institution copies of all data, reports, records and materials in
deCODE's possession or control which relate to such Products; (ii) all licenses
granted for Patent Rights covering such Product in such country by Institution
to deCODE under Section 2 shall terminate; (iii) all sublicenses granted by
deCODE under this Agreement with respect to such Product in such country shall
be subject to Section 9.7, and (iv) ownership of all INDs, NDAs and other
regulatory filings made or filed for such Product in such country shall be
transferred to Institution. Thereafter, Institution shall have the right to
develop, make, have made, use, sell or have sold such Product in such country,
subject to such sublicenses.
9.6.4 Upon termination of this Agreement in its entirety by deCODE
pursuant to Section 9.4, in addition to any other remedies available to deCODE
at law or in equity: (i) Institution shall promptly transfer to deCODE copies of
all data, reports, records and materials in Institution's possession or control
that relate to the Products; (ii) return to deCODE all relevant records and
materials in Institution's possession or control containing Confidential
Information of deCODE; and (iii) ownership of all INDs, NDAs and other
regulatory filings made or filed for any Product shall be transferred solely to
deCODE. The right and license granted to deCODE by Institution pursuant to
Section 2 shall continue in full force and effect without further obligation to
Institution.
9.6.5 Upon termination of this Agreement by Institution pursuant to
Section 9.4, in addition to any other remedies available to Institution at law
or in equity: (i) deCODE shall promptly transfer to Institution copies of all
data, reports, records and materials in deCODE's possession or control; (ii)
return to Institution all relevant records and materials in deCODE's possession
or control containing Confidential Information of Institution; (iii) all
licenses granted
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for Patent Rights by Institution to deCODE under Section 2 shall terminate; (iv)
all sublicenses granted by deCODE under this Agreement shall be subject to
Section 9.7, and (v) ownership of all INDs, NDAs and other regulatory filings
shall be transferred to Institution. Thereafter, Institution shall have the
right to develop, make, have made, use, sell or have sold Products, subject to
such sublicenses.
9.6.6 Upon termination of this Agreement with respect to any
Product in any country by deCODE pursuant to Section 7.9 or 9.2: (i) each Party
shall promptly transfer to the other Party copies of all data, reports, records
and materials of the other Party in the possession or control of such Party
which relate to such Product; and (ii) all licenses granted by either Party to
the other Party under Section 2 shall terminate. Thereafter, each Party shall
have the right to develop, make, have made, use, sell or have sold such Product
in such country, to the extent legally permissible.
9.7 Rights Under Sublicenses Upon Termination. In the event that any
license granted to deCODE under this Agreement is terminated, any sublicense
under such license granted prior to termination of said license shall remain in
full force and effect, provided that:
9.7.1 The Sublicensee is not then in breach of its sublicense
agreement;
9.7.2 The Sublicensee agrees to assume the rights and
obligations of deCODE under the terms and conditions of this Agreement, as
modified by the provisions of this Section 9.7;
9.7.3 The Sublicensee, at Institution's written request,
assumes in a signed writing the same obligations to Institution as those assumed
by deCODE under Sections 8 and 11;
9.7.4 Institution shall have the right to receive the greater
of (a) any payments payable to deCODE under such sublicense agreement to the
extent they are reasonably and equitably attributable to such Sublicensee's
right under such sublicense to use and exploit Patent Rights and/or
Technological Information or (b) the lowest royalty which is within the
"Competitive" range as hereinafter defined, at the time Institution's license to
deCODE is terminated. A royalty rate shall be regarded as "Competitive" if it is
within the range of royalty rates that Institution would charge in an arms
length transaction with a licensee which was not and had not been a sponsor of
research at Institution, taking into account the value of the licensed
technology at the time Institution's license to deCODE is terminated; and
9.7.5 Institution shall not assume, and shall not be
responsible to such Sublicensee for, any representations, warranties or
obligations of deCODE to such Sublicensee, other than to permit such Sublicensee
to exercise any rights to Patent Rights and Technological Information that are
granted under such sublicense agreement consistent with the terms of this
Agreement.
9.8 Payment of Royalties Upon Termination. Upon termination of any
license granted hereunder, deCODE shall pay Institution all royalties due or
accrued on (a) the sale of Products
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up to and including the date of termination, and (b) for twelve (12) months
following the date of termination, the sale of Products manufactured prior to
the termination date.
10. Representations and Warranties.
10.1 Ownership. Institution represents and warrants that: (a) to the
best of its knowledge, Institution is the owner of all right, title and interest
in the Patent Rights and has the right to grant the right and license granted to
deCODE under this Agreement; and (b) Institution has not entered into any
agreement with any Third Party which is in conflict with the rights granted to
deCODE pursuant to this Agreement. Notwithstanding the foregoing, Institution
makes no representation or warranty as to the validity of any Patent Rights
licensed under this Agreement.
10.2 Disclosure. Institution represents and warrants that it has fully
disclosed to deCODE all information in Institution's possession or control
relating to the Patent Rights, including, without limitation, any communications
with any Third Parties relating to any of the foregoing.
10.3 Power to Grant License. Institution represents and warrants that
it is not prohibited by the United States Government or by any other foreign or
domestic governmental authority from granting the right and license in the
Patent Rights and Technological Information to deCODE under this Agreement
10.4 Survival. The representations and warranties contained in this
Section 10 shall survive the termination of this Agreement.
11. Alternative Dispute Resolution.
11.1 Negotiation. The Parties shall attempt in good faith to resolve,
through negotiation any dispute, claim or controversy arising out of or relating
to this Agreement. Either Party may initiate negotiations by providing written
notice in letter form to the other party, setting forth the subject of the
dispute and the relief requested. The recipient of such notice shall respond
within five (5) days with a written statement of its position on, and
recommended solution to, the dispute. If the dispute is not resolved by this
exchange of correspondence, then representatives of each Party with full
settlement authority shall meet at a mutually agreeable time and place within
ten (10) days of the date of the initial notice in order to exchange relevant
information and perspectives, and to attempt to resolve the dispute.
11.2 Arbitration. Except with respect to breaches for which a Party is
seeking injunctive relief, all disputes between the Parties relating to this
Agreement or the subject matter hereof which cannot be resolved by the Parties
according to Section 11.2.1 shall, be submitted for final and binding
arbitration before JAMS/Endispute ("JAMS") pursuant to the United States
Arbitration Act, 9 U.S.C. Sec. 1 et seq., and shall be held at a mutually
agreeable location or in New York City. Any Party may commence the arbitration
process pursuant to this Agreement by filing a written demand for arbitration
with JAMS, with a copy to the other Party. Unless the
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Parties otherwise agree in writing: the arbitration shall be conducted in
accordance with the provisions of JAMS Comprehensive Arbitration Rules and
Procedures in effect at the time of filing of the demand for arbitration if the
amount in controversy is greater than $250,000, exclusive of interest; or the
arbitration shall be conducted in accordance with the provisions of JAMS
Streamlined Arbitration Rules and Procedures in effect at the time of filing of
the demand for arbitration if the amount in controversy is $250,000 or less,
exclusive of interest. The Parties will cooperate with JAMS and with one another
in selecting an arbitrator from JAMS' panel of neutrals, and in scheduling the
arbitration proceedings; provided, however, that all arbitrators must be
knowledgeable in the pharmaceutical industry or bioinformatics or other
technology areas as appropriate to the Patent Rights licensed hereunder, and
must not be affiliated through employment or otherwise with a competitor of
either Party, as determined through mutual assent of the Parties. The Parties
shall participate in the arbitration in good faith, and shall share equally in
its costs. The provisions of this Section may be enforced by any Court of
competent jurisdiction, and the Party seeking enforcement shall be entitled to
an award of all costs, fees and expenses, including attorneys fees, to be paid
by the party against whom enforcement is ordered.
11.3 Injunction. This Section 11 shall not prohibit a Party from
seeking injunctive relief from a court of competent jurisdiction in the event of
a breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
12. Miscellaneous.
12.1 Governing Law. This Agreement will be governed by, construed, and
interpreted in accordance with the laws of the State of Delaware, without
reference to principles of conflicts of laws.
12.2 Assignment. Neither Party shall assign its rights or duties under
this Agreement to another without the prior express written consent of the other
Party, which consent shall not be unreasonably withheld; provided, however, that
either Party may assign this Agreement to a successor in ownership of all or
substantially all its business assets. Such successor shall expressly assume in
writing the obligation to perform in accordance with the terms and conditions of
this Agreement.
12.3 Notices. All notices, demands and other communications of every
kind and description whatsoever required or permitted under this Agreement shall
be in writing and shall be deemed to have been received when personally
delivered, or when shipped by private express carrier (signature required),
shipment charges prepaid, or when sent via facsimile transmission (receipt
verified) to the Party to whom delivery shall be made at the respective
addresses as set out below.
If to Institution, to:
Institution:
_________________________________________
Attn:
_________________________________________________
Licensing
____________________________________________
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Institution Agreement #
______________________________
Telephone:
___________________________________________
Facsimile:
If to deCODE, to:
____________________________________
deCODE genetics Ltd.
Xxxxxxxxx 0
XX-000 Xxxxxxxxx, Xxxxxxx
Attn:
________________________________________________
Telephone: x000-000-0000
Facsimile: x000-000-0000
12.4 Modification. No modification or waiver of this Agreement or of
any covenant, condition, or limitation herein contained shall be valid unless in
writing and duly executed by both Parties.
12.5 Waiver. No waiver of any rights will be effective unless assented
to in writing by the Party to be charged and the waiver of any breach or default
will not constitute a waiver of any other right hereunder or any subsequent
breach or default.
12.6 Headings. The Section headings are intended for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
12.7 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement will continue in full force and effect
without said provision; provided that no such severability will be effective if
the result of such action materially changes the economic benefit of this
Agreement to deCODE or to Institution.
12.8 Construction. The Parties have participated equally in the
creation of this Agreement; the language of this Agreement will not be
presumptively construed against either party.
12.9. Survival. Sections 1, 6, 7, 8, 9.5, 9.6, 9.7, 9.8, 10, 11, 12.1,
12.7, 12.8 and 12.9 shall survive any expiration or termination of this
Agreement.
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12.10 Counterparts. This Agreement may be executed in counterparts,
each of which will be deemed an original, but all of which together will
constitute one agreement.
* * *
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In witness whereof, the Parties have caused this Agreement to be
executed by their duly authorized representatives as of the date first set forth
above.
INSTITUTION: DECODE GENETICS LTD.:
BY:__________________________ BY:___________________________
NAME:__________________________ NAME:____________________________
TITLE:__________________________ TITLE:____________________________
DATE:__________________________ DATE:____________________________
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[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.]
CLINICAL TRIAL AGREEMENT
BETWEEN
[NAME OF INSTITUTION]
AND
DECODE GENETICS LTD.
DATED ____________, 2000
93
CLINICAL TRIAL AGREEMENT
THIS CLINICAL TRIAL AGREEMENT (this "Agreement") effective _____ day of
____, 2000 ("Effective Date"), is by and between [name of Partners' Institution]
(for example, The General Hospital Corporation d.b.a. Massachusetts General
Hospital, a Massachusetts not-for-profit corporation having its principal
offices at 00 Xxxxx Xxxxxx, Xxxxxx, XX 00000 or The Xxxxxxx and Women's
Hospital, Inc., a Massachusetts not-for-profit corporation having its principal
offices at 00 Xxxxxxx Xxxxxx, Xxxxxx, XX 02115) ("Institution"), acting on
behalf of ________________, M.D., Department of __________,
_____________________________________ ("Principal Investigator"), and deCODE
genetics Ltd., an Icelandic corporation which is a wholly-owned subsidiary of
deCODE genetics, Inc., a Delaware corporation, and having an office at Xxxxxxxxx
0, XX-000 Xxxxxxxxx, Xxxxxxx ("deCODE") (Institution and deCODE, each a "Party;"
collectively, the "Parties").
BACKGROUND
The Parties to this Agreement share a common mission of improving the
public health by engaging in research for the purpose of discovering and making
available to the public new and improved medical drugs and devices. In
connection with this mission, deCODE desires to have further clinical research
conducted on its [DRUG/DEVICE] described below. Institution and Principal
Investigator, having particular expertise and opportunity, desire to provide
this research.
The Parties have, therefore, agreed as follows:
1. Definitions.
1.1 "Approved Subcontractee" shall mean have the meaning assigned to such
term in Section 2.1.
1.2 "Confidential Information" of a Party shall mean all technical or
marketing reports, data or information disclosed by such Party to the other
Party which is in writing and marked "Confidential, "Proprietary" or the like,
or, if disclosed orally, is indicated as confidential at the time of disclosure
and is summarized in writing and marked or otherwise designated in writing as
"Confidential, "Proprietary" or the like within thirty (30) days after such
disclosure, provided, however, that Study Data, other than deCODE Study Data set
forth on Appendix B and Research Data other than deCODE Research Data set forth
on Appendix E of the Sponsored Research Agreement shall not be considered
Confidential Information of the disclosing Party.
1.3 "Copyright" shall mean the copyright subsisting in accordance with
United States Copyright Law, foreign copyright laws and international agreements
in the Copyrightable Work, together with any United States or foreign copyright
registration application or resulting copyright registration.
1.4 "Copyrightable Work" shall mean any original work of authorship fixed
in any tangible medium of expression, now known or later developed, from which
it can be perceived,
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reproduced, or otherwise communicated, either directly or with the aid of a
machine or device, including without limitation computer programs and related
documentation, which is authored by any Investigator solely or jointly with
deCODE or deCODE personnel in the conduct of the Study, or prepared by any
Investigator in the conduct of the Study and within the scope of his or her
employment by Institution as a Work-Made-For-Hire (as that capitalized term is
defined in United States Copyright Law) for which Institution is considered the
author and owner solely or jointly with deCODE or deCODE personnel.
Notwithstanding the foregoing, as used herein, "Copyrightable Work" shall
exclude (a) databases and (b) works authored by any Investigator of an academic
or scholarly nature such as notebooks, textbooks, publications or abstracts in
scientific journals or presentations, regardless of whether such works were
created in conduct of the Study.
1.5 "Crosswalk Development Agreement" shall mean the agreement between
Partners Healthcare Systems, Inc., The General Hospital Corporation d.b.a.
Massachusetts General Hospital, The Xxxxxxx and Women's Hospital and deCODE
dated May 11, 2000.
1.6 "CSRL" shall mean the Institution's Corporate Sponsored Research and
Licensing office, or any successor thereto.
1.7 "deCODE" shall have the meaning assigned to such term in the
Introductory paragraph.
1.8 "deCODE Materials" shall mean any biological material or substance
first discovered, produced or made by an employee of deCODE or otherwise to
which deCODE has rights and which deCODE provides to Institution in connection
with the Study pursuant to this Agreement; provided however, that deCODE
Materials shall not include tissues, bodily fluids, or other materials from
patients, including without limitation genetic material.
1.9 "deCODE Notice" shall have the meaning assigned to such term in the
Strategic Alliance Agreement.
1.10 "deCODE Representative" shall be ____________________, or such other
representative as deCODE may subsequently designate in writing, who shall be
responsible for the communications and collaboration with Institution relating
to the Study.
1.11 " deCODE Research Data"shall have the meaning assigned to such term
in the Sponsored Research Agreement.
1.12 "deCODE Study Data" shall mean any research data, formulae, process
information or other information pertaining to the Study, and produced by a
deCODE employee or consultant in the performance of, or relating to, the Study,
including without limitation any research data, formulae, process information or
other information provided by deCODE to Institution or its Investigators for the
purpose of performing or in connection with the performance of the Study.
Notwithstanding the foregoing, the term "deCODE Study Data" shall not include
patient identifiers or other patient confidential information.
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1.13 "Effective Date" shall have the meaning assigned to such term in the
Introductory paragraph.
1.14 "Field of Study" shall mean ___________ [TO BE DEFINED TAKING INTO
CONSIDERATION ITS USE IN SECTION 2.5.].
1.15 "Indemnitees" shall have the meaning assigned to such term in Section
13.1.1.
1.16 "Institution" shall have the meaning assigned to such term in the
Introductory paragraph.
1.17 "Institution Materials" shall mean any biological material or
substance first discovered, produced or made by an Investigator in the
performance of Study; provided, however, that Institution Materials shall not
include tissues, bodily fluids, or other materials from patients, including
without limitation genetic material.
1.18 "Institution Notice" shall have the meaning assigned to such term in
the Strategic Alliance Agreement.
1.19 "Institution Study Data" shall mean any research data, formulae,
process information or other information pertaining to the Study produced by an
Investigator in the performance of Study, but shall not include patient
identifiers or other patient confidential information.
1.20 "Intellectual Property Rights" shall mean the statutory rights and
protection afforded Patent Rights and/or Copyrightable Works by the patent and
copyright laws of the country where such right is sought, it being understood
that any individual category of intellectual property may be afforded more than
one such statutory right.
1.21 "Invention" shall mean any new and useful process, machine,
manufacture, or composition of matter conceived and reduced to practice, solely
or jointly, by any Investigator in the performance of the Study.
1.22 "Investigator" shall mean the Principal Investigator and any other
member of Institution's Professional Staff, graduate student, undergraduate
student, or employee of Institution who shall conduct the Study under the
direction of the Principal Investigator.
1.23 "IP Costs" shall have the meaning assigned to such term in Section
7.5.
1.24 "IP Project Leader" shall have the meaning assigned to such term in
the Strategic Alliance Agreement.
1.25 "IRB" shall have the meaning assigned to such term in Section 2.2.
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1.26 "JAMS" shall have the meaning assigned to such term in Section 16.2.
1.27 "Joint Copyrightable Work" shall have the meaning assigned to such
term in Section 7.3.
1.28 "Joint Invention" shall have the meaning assigned to such term in
Section 7.3.
1.29 "Joint Study Data" shall mean any research data, formulae, process
information or other information pertaining to the Study which is jointly
produced by one or more Investigators and one or more deCODE employees or
consultants in the performance of Study, but does not include patient
identifiers or other patient confidential information.
1.30 "Materials" shall mean deCODE Materials and Institution Materials
collectively.
1.31 "Party" or "Parties" shall have the meanings assigned to such terms
in the Introductory paragraph.
1.32 "Patent Rights" shall mean any United States patent application,
including any division or continuation and any foreign patent application or
equivalent corresponding thereto and any Letters Patent or the equivalent
thereof issuing thereon or reissue or extension thereof, which contains one or
more claims to an Invention. Patent Rights shall also include those claims of
any continuation-in-part of the aforementioned patent applications to the extent
they claim an Invention.
1.33 "Patient Tissues" shall mean any tissues, bodily fluids, or other
materials from patients, including without limitation genetic material.
1.34 "Principal Investigator" shall mean, who shall be responsible for the
direction and conduct of the Study at Institution.
1.35 "Research Data" shall have the meaning assigned to such term in the
Sponsored Research Agreement.
1.36 "Sponsored Research Agreement" shall mean that certain Sponsored
Research Agreement among the Parties, dated [____________].
1.37 "Strategic Alliance Agreement" shall mean the agreement between
Partners Healthcare Systems, Inc., The General Hospital Corporation d.b.a.
Massachusetts General Hospital, The Xxxxxxx and Women's Hospital and deCODE
dated May 11, 2000.
1.38 "Study" shall mean have the meaning assigned to such term in Section
2.1.
1.39 "Study Data" shall mean deCODE Study Data, Institution Study Data and
Joint Study Data, collectively.
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1.40 "Study [DRUG\DEVICE]" shall have the meaning assigned to such term in
Section 2.3.
1.41 "Term" shall have the meaning assigned to such term in Section 12.1.
1.42 "Third Party Project" shall have the meaning assigned to such term in
Section 2.5.2.
1.43 "Transfer Letter" shall mean the correspondence to accompany the
transfer of Materials is substantially the same form as that attached as
Appendix F.
2. Study Performance.
2.1 Protocol. Subject to approval by all appropriate and necessary
authorities pursuant to Section 2.2 below, Principal Investigator agrees to
conduct a clinical trial in accordance with the study protocol entitled
"________________________________", a copy of which is attached hereto as
Appendix A (hereinafter referred to as the "Study"). In the event of any
conflict between Appendix A and the provisions of this Agreement, the provisions
of this Agreement shall govern.
2.2 Study Review. The Study shall be conducted by staff members of
Institution under the direction of the Principal Investigator at Institution or
elsewhere with the prior approval and ongoing review of all appropriate and
necessary review authorities and in accordance with all applicable federal,
state and local laws and regulations. The Study may also be subcontracted to
other sites which have been approved by deCODE ("Approved Subcontractee"),
provided that any such Approved Subcontractee agrees in writing to be bound by
the terms of this Agreement. Principal Investigator shall provide deCODE with
written evidence of review and approval of this Study by Institution's
Institutional Review Board ("IRB") prior to the initiation of the Study and
shall inform deCODE of the IRB's continuing review promptly after such review
takes place, which shall be at least once per year.
2.3 Study Drug. deCODE shall provide Institution, at no charge, with
quantities of [NAME OF DRUG/DEVICE] required for the Study (the "Study
[DRUG/DEVICE]"). If deCODE has failed to provide necessary Study [DRUG/DEVICE]
at the time of the scheduled Study initiation, deCODE shall reimburse
Institution for reasonable costs incurred during such delay. The Institution and
Principal Investigator shall safeguard such Study [DRUG/DEVICE] with the degree
of care used for their own property. Upon completion or termination of the Study
and upon deCODE's request, Institution shall return or otherwise dispose of any
remaining Study [DRUG/DEVICE] in accordance with deCODE's instructions.
Institution and Principal Investigator shall not use any Study [DRUG/DEVICE] for
any purpose other than the Study without the prior written consent of deCODE.
2.4 Change in Principal Investigator. If for any reason Dr.__________ is
unable to fulfill the responsibilities of the Principal Investigator required to
carry out the Study, the Parties shall negotiate in good faith the continuance
of the Study under the direction and supervision of a different Principal
Investigator. However, if a Principal Investigator satisfactory to deCODE
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cannot be agreed upon, then deCODE may terminate this Agreement immediately upon
giving notice thereof.
2.5 Exclusivity.
2.5.1 At any time during the term of this Agreement, either Party
may propose in writing additional study in the Field of Study not previously
described in the Study as set forth in Appendix A. Each such proposal shall
include a description of the additional research proposed, a budget of the costs
to be funded by deCODE, and a schedule of payment of such costs. Unless the
Parties shall otherwise agree in writing, negotiations between them over any
such proposal shall not extend beyond the sixtieth (60th) day next following the
date when the proposal shall have first been so made, and whenever such
negotiations shall end without agreement between the Parties to proceed with the
proposed research, the Party proposing the additional research may proceed
without the other Party and seek funding from any other sponsor, including but
not limited to a commercial sponsor, as set forth in Section 2.5.2. When such
proposal is accepted by Institution and deCODE, it shall be appended hereto as
an addendum to the Study and shall be subject to the terms and conditions of
this Agreement unless otherwise specified, and the Study described therein shall
commence and budgeted amounts shall be paid as set forth in the proposal or as
otherwise agreed by the Parties in writing. In no event shall any additional
research be added to the Study nor shall the direction of the Study be altered
without the concurrence of the Director of CSRL of the Institution.
2.5.2 Notwithstanding any contrary provision, an Investigator shall
not seek funding from another commercial sponsor for an additional study
proposal in the Field of Study unless and until such proposal has been submitted
to deCODE in accordance with the foregoing Section 2.5.1 and the Parties have
failed to agree in writing to append such proposal hereto as an addendum to the
Work Plan within the stipulated sixty (60) days. In the event of such failure to
agree, an Investigator shall be free to seek and accept funding from such
commercial sponsor for such research proposal (the "Third Party Project"),
provided that, in the reasonable determination of the Joint Steering Committee
created pursuant to the Strategic Alliance Agreement, after consultation with
the Investigator: (a) the subject matter of the Third Party Project is not so
closely related scientifically to the Study that sponsorship of such Third Party
Project by such other commercial sponsor would create a conflict of interest for
Institution or any Investigator performing the Study; (b) the risk of subject
matter overlaps between the Study and such Third Party Project is minimal; (c)
the Third Party Project would not conflict with the terms and conditions of this
Agreement and would not have a material impact on the Study or Institution's
ability to perform the Study; and (d) such other commercial sponsor of the Third
Party Project is not a competitor of deCODE in any of its business areas that
would create a conflict of interest.
2.5.3 An Investigator shall be free at any time to seek funding for
any research in the Field of Study, including additional funding for the Study,
from any international, state or federal agency, or from any not-for profit
foundation, except foundations owned or operated by a commercial entity other
than deCODE or which have obligations to commercial entities with respect to
such research; provided, however, that such Investigator shall follow the
procedures set forth in Section 5 with respect to any grant applications and
progress reports disclosing Study
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Data and Section 6 of the Sponsored Research Agreement with respect to any grant
applications and progress reports disclosing Research Data.
2.5.4 Investigators shall be free at any time to seek funding from
any source for any research outside the Field of Study.
3. Transmission of, and Rights To Use, Institution Materials and deCODE
Materials.
3.1 Use of deCODE Materials by Institution. Institution and
Principal Investigator shall not distribute deCODE Materials to anyone other
than Investigators or use them for any purpose other than the Study without the
prior written approval of deCODE.
3.2 Use of Institution Materials by deCODE. Upon deCODE's request,
Principal Investigator shall provide deCODE with an amount of such Institution
Materials as is reasonably requested and shall not interfere with Investigators'
ability to conduct the Study. deCODE shall have the right to use Institution
Materials provided to it for: (a) any commercial purposes, including but not
limited to the development, manufacture, sale and use of any product; (b) for
research and development purposes, provided, however, that uses that may lead to
publications are discussed in advance with the Principal Investigator and that
Investigators who produced the Institution Materials are given credit in
accordance with scientific custom, by acknowledgment or co-authorship as
appropriate, in any resulting publications; and (c) transfers to third parties;
provided, however, that deCODE has obtained the prior written permission of the
Principal Investigator for such transfers.
3.3 Transfer Letters. Institution Materials provided to deCODE and
deCODE Materials provided to Investigators shall be accompanied by, and subject
to the terms of, a Transfer Letter in substantially the same form as that
attached as Appendix F.
3.4 Use of Institution Materials by Institution.
3.4.1 During the period the Study is being performed hereunder,
Institution and Principal Investigator shall have the right to transfer
Institution Materials to not-for-profit entities or persons known to be
affiliated therewith, provided that such entities or persons agree in writing
not to: (a) transfer such Institution Materials to any other person or entity;
and (b) use such Institution Materials for commercial purposes.
3.4.2 During the period the Study is being performed hereunder,
Institution and Principal Investigator shall not, without deCODE's prior written
approval, distribute or knowingly allow to be distributed Institution Materials
to for-profit entities or persons known to be employed thereby or performing
research sponsored thereby in the Field of Study unless:
(a) A description of the Institution Materials is published in
a journal that requires dissemination of described materials as a condition for
publication;
(b) Institution and deCODE have mutually agreed not to seek
Patent
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Rights claiming such Institution Materials or its manufacture or use; or
(c) Such distribution is required by the policies, regulations
or guidelines of the U.S. government.
3.4.3 Under the circumstances described in 3.4.2(a), (b) or (c),
Institution and Principal Investigator shall have the right to distribute such
Institution Materials to:
(a) Such entities or persons who agree in writing not to (i)
transfer such Institution Materials to any other person or entity; and (ii) use
such Institution Materials for commercial purposes; and
(b) Third persons solely for the purpose of obtaining
chemical, physical, or biological analysis or characterization of such
Institution Materials, provided that such persons agree in writing not to (i)
transfer such Institution Materials or any non-public information regarding such
Institution Materials to any other person or entity; and (ii) use such
Institution Materials for any purpose other than the agreed-upon analysis or
characterization and not to disclose such analysis or characterization to any
third party.
3.5 Transfer Agreement for Patient Tissues. In the event that any Patient
Tissues are to be transferred from Institution to deCODE for the purposes of the
Study, such Patient Tissues shall be provided under the terms and conditions of
a Transfer Agreement for Patient Tissue Samples in substantially the same form
as that attached as Appendix G.
4. Results of the Study.
deCODE shall own its case report forms and shall have the unrestricted
right to use the data from the Study, provided, however, that deCODE shall not
use any patient names, identifying information, photographs, or other likenesses
without first obtaining the specific written informed consent of such patient
for such use. Institution shall own its medical records, research notebooks and
related documentation.
5. deCODE Confidential Information.
5.1 Confidentiality Obligation. Except as otherwise provided in Section
5.2, for a period of ten (10) years from the Effective Date, or, with respect to
deCODE Study Data set forth on Appendix B and deCODE Research Data set forth on
Appendix E in the Sponsored Research Agreement, such shorter time period as the
Parties and the Principal Investigator may agree to in writing, Institution
agrees to use all reasonable efforts, no less than those used to protect its own
confidential information, not to disclose to third parties any Confidential
Information disclosed to it by deCODE.
5.2 Permitted Disclosures. Nothing in this Agreement shall limit any Party
in any way from: (a) disclosure of information required by a public authority;
or (b) disclosure of information
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that is necessary to prevent imminent danger to the public; provided, however,
in each case the disclosing Party shall promptly inform the other Party of its
intent to disclose such information and the reasons for such disclosure.
5.3 Exceptions. The Institution shall have no obligation of
confidentiality with respect to any portion of such Confidential Information
which:
5.3.1 As of the Effective Date, is part of the public domain;
5.3.2 Subsequently becomes part of the public domain through no
fault of Institution;
5.3.3 Which Institution can show was in its possession, as evidenced
by written records kept in the ordinary course of business or by the proof of
actual use at the time of executing this Agreement, and which information had
not been wrongfully acquired, directly or indirectly, from deCODE;
5.3.4 Which is subsequently disclosed to Institution by a third
party not in violation of any right of, or obligation to, deCODE hereto;
5.3.5 Is required to be disclosed by operation of law, provided that
deCODE has received advanced notice of the proposed disclosure by Institution,
or
5.3.6 Is developed by or on behalf of Institution without reference
to deCODE's Confidential Information, as evidenced by written records.
5.4 Injunctive Relief. In addition to any other right or remedy it may
have and without the posting of any bond or other security, deCODE shall be
entitled to obtain injunctions to enjoin or restrain Institution from any
violation or threatened violation of this Section 5.
6. Publication.
6.1 Submission. Prior to public presentation or submission to a journal,
international, federal or state agency, or not-for-profit foundation, as the
case may be, the Principal Investigator shall submit for review to the deCODE
Representative an early draft of any manuscript, abstract, public oral
presentation or progress report containing Study Data or Research Data.
6.2 Review Period. Within thirty (30) days of receipt of such manuscript,
or within seven (7) days of receipt of an abstract of a public oral presentation
from the Principal Investigator, deCODE shall submit its comments, if any, to
the Principal Investigator. The Investigators shall give due consideration to
any comments made by deCODE, but shall not be required to incorporate any of
deCODE's comments, and the Investigators' decision as to the information to be
contained in such manuscript, presentation, or abstract shall be final, except
that upon deCODE's notification, the Investigators shall delete deCODE's
Confidential Information and deCODE Study Data set forth on Appendix B and
deCODE Research Data set forth on
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Xxxxxxxx X of the sponsored Research Agreement. In any publication or
presentation containing Study Data or Research Data, each Party shall
acknowledge the role and contribution of the other Party to the Study.
6.3 Delay for Patent Filing. If deCODE has reason to believe that any such
manuscript, abstract, presentation, progress report or any grant application
provided in accordance with Section 6.5 reveals a potentially patentable
Invention, deCODE shall notify the Principal Investigator and Institution in
writing within the time periods indicated in Section 6.2, 6.4 or 6.5, as the
case may be. In such case, the Investigators agree to delay submission for
publication, public presentation, or submission to an agency or not-for-profit
foundation, as the case may be, until the earlier to occur of the following:
6.3.1 A U.S. patent application has been filed;
6.3.2 Institution's CSRL has determined, in consultation with
deCODE, that no patentable Invention exists; or
6.3.3. Sixty (60) days have passed from the date of such
notification by deCODE.
6.4 Competitive Publications. If a deCODE employee or Investigator
receives reasonable indications concerning the imminent oral presentation or
publication of a manuscript or abstract by a third party that is similar in
content to the presentation, manuscript or abstract containing Study Data or
Research Data proposed to be published or presented by an Investigator, the
Parties agree as follows:
6.4.1 The deCODE employee or Investigator shall notify the other
Party in writing as soon as reasonably practical about such other imminent
presentation or publication; and
6.4.2 The time periods for presentation or publication review and
delay stated in Sections 6.1, 6.2 and 6.3 shall be shortened as mutually agreed.
6.5 Grant Submissions. Investigators shall have the right to submit grant
applications related to the Study and/or disclosing any Study Data, except for
deCODE Research Data set forth on Appendix E of the Sponsored Research
Agreement, deCODE Study Data set forth in Appendix B, or the nature of the
relationship among the Parties to any international, federal or state agencies
or not-for-profit foundations which do not require licensing to a commercial
entity; provided, however, that such Investigators shall provide a draft of such
grant applications to deCODE at least fifteen (15) days prior to such submission
to such agencies or foundations. In the event that an Investigator wants to
exclude from review any portions of a grant application that does not disclose
any such Study Data, Research Data or the nature of the relationship among the
Parties, then such Investigator shall provide to deCODE: (a) a draft of all
other portions of such grant application, including all portions disclosing any
Study Data or Research Data; and (b) a certification from the Principal
Investigator and IP Project Leader that deCODE has been provided with all
portions of such grant application disclosing Study Data or Research Data and
all portions reasonably necessary for deCODE to determine whether such grant
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application reveals a potentially patentable Invention. In such event, deCODE
may request additional information as it deems reasonably necessary or desirable
to make such a determination. Such grant submission shall be subject to Section
6.3. When so requested by deCODE, Institution and Investigators shall indicate
on such grant application that certain proprietary business information is
contained therein which is not subject to disclosure under the Freedom of
Information Act, and shall request that such information be treated as
confidential.
7. Intellectual Property Rights.
7.1 Ownership by Institution. Each Investigator who shall (a) solely or
jointly make an Invention or (b) solely or jointly author or prepare a
Copyrightable Work, shall promptly report such Invention or Copyrightable Work
to the Institution. Such Investigator shall assign all of his or her rights,
title and interest in any such Invention, including any Patent Rights, or
Copyrightable Work to the Institution (to the extent that such Copyrightable
Work is not already owned by such Institution as a Work-Made-For-Hire under
United States Copyright Law).
7.2 Ownership by deCODE. Each deCODE employee who shall (a) solely or
jointly make a Invention or (b) solely or jointly author or prepare a
Copyrightable Work, shall promptly report such Invention or Copyrightable Work
to deCODE. Such deCODE employee shall assign all of his or her rights, title and
interest in any such Invention, including any Patent Rights, or Copyrightable
Work to deCODE (to the extent that such Copyrightable Work is not already owned
by deCODE as a Work-Made-For-Hire under United States Copyright Law).
7.3 Joint Ownership. If an Invention is invented by one or more
Investigator(s) and one or more deCODE employee(s) such Investigator(s) and
deCODE employee(s) shall assign all of their right, title and interest in any
such Invention (a "Joint Invention") to their respective employers. If a
Copyrightable Work is authored or created by one or more Investigator(s) and one
or more deCODE employee(s) (a "Joint Copyrightable Work") such Investigator(s)
and deCODE employee(s) shall assign all of their rights, title and interest in
such Joint Copyrightable Work to their respective employers (to the extent that
such deCODE employees' and Investigators' contributions to such Joint
Copyrightable Work is not already owned by deCODE or the Institution as a
Work-Made-For-Hire under the United States Copyright Law). For each Joint
Invention, the Institution and deCODE shall each own an undivided interest in
such Invention in each country in which it is filed and granted. For each Joint
Copyrightable Work, the Institution and deCODE shall each own an undivided
interest in such Copyright in each country where Copyright protection results.
Institution and deCODE shall each have the right to sell, license or otherwise
transfer its rights to such Joint Invention or Joint Copyrightable Work in any
country without the consent of the other; provided, however, that the
Institutions shall be subject to the terms and conditions of this Agreement and
the Strategic Alliance Agreement.
7.4 Disclosure between Parties. Each Party shall promptly advise the other
in writing of each: (a) Invention, including without limitation any Joint
Invention; or (b) Copyrightable Work, including without limitation any Joint
Copyrightable Work, disclosed to it. Representatives of Institution and deCODE
shall then discuss whether applications for Intellectual Property Rights shall
be sought and in which countries. If both Parties mutually agree that such
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application(s) should be filed, applications assigned solely to Institution
shall be filed by Institution, applications assigned solely to deCODE shall be
filed by deCODE, and jointly assigned applications shall be filed as mutually
agreed upon by the Parties. The titles, serial numbers and other identifying
data of any applications for Intellectual Property Rights shall be added to
Appendix E of this Agreement.
7.5 Costs. Reasonable and customary costs incurred by Institution for
filing, obtaining and maintaining Intellectual Property Rights filed by mutual
agreement ("IP Costs") shall be reimbursed in full by deCODE upon deCODE's
receipt of Institution's notice of payment of such IP Costs, except as provided
for below. Such IP Costs shall include but not be limited to the costs of
preparing, filing, prosecuting (including mutually agreed upon interferences or
oppositions), issuing or maintaining and working Intellectual Property Rights,
including without limitation the Patent Rights and Copyrights. For IP Costs not
reimbursed by deCODE within thirty (30) days after receipt of Institution's
notice of payment of such IP Costs, deCODE shall pay Institution interest at the
rate of [CONFIDENTIAL TREATMENT REQUESTED] per month compounded each month that
such IP Costs remain unpaid. For Intellectual Property Rights in which other
commercial entities have acquired license rights, deCODE shall reimburse
Institution only for the same share of such IP Costs as reimbursed by each of
the other commercial entities, but in no event shall deCODE be required to
reimburse Institution for more than [CONFIDENTIAL TREATMENT REQUESTED] of the IP
Costs for such Intellectual Property Rights.
7.6 deCODE Waives Filing. In the event deCODE is interested in having
Intellectual Property Rights filed with respect to a particular Invention or
Copyrightable Work made solely by Investigators, deCODE shall advise Institution
of such interest, in writing, within ninety (90) days from the date on which the
Invention or Copyrightable Work was disclosed to deCODE by Institution or
sooner, as specified by Institution, if necessary to avoid the loss of
Intellectual Property Rights. In the event that deCODE notifies Institution
within such ninety (90) day period that it is not interested in acquiring the
benefits of Intellectual Property Rights to such Invention or Copyrightable
Work, or fails to notify Institution, in writing, within such period that it is
interested in acquiring the benefits of such Intellectual Property Rights, then
Institution at its own expense may file and maintain such Intellectual Property
Rights in any country where deCODE elects not to file. Such Intellectual
Property Rights shall not be included with the Intellectual Property Rights
licensed to deCODE pursuant to Sections 8.1 and 8.2 of this Agreement, and
Institution shall be free to license such Intellectual Property Rights to any
third party.
7.7 Institution Waives Filing. In the event that Institution does not wish
to file an application for Intellectual Property Rights with respect to a
particular Invention or Copyrightable Work made by Investigators, including any
Joint Invention or Joint Copyrightable Work, or does not wish to file such
applications with respect to specific countries, it shall first without delay
notify deCODE, and deCODE shall be free, where not contrary to United States
law, to file at its expense applications for such Intellectual Property Rights,
in the name of Institution if necessary. Institution shall render deCODE, at
deCODE's expense, all reasonable assistance in order to facilitate such filing.
Any such application shall be considered an Intellectual Property Right for all
purposes of this Agreement.
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7.8 deCODE Waives License. Notwithstanding any other provision of this
Agreement, once deCODE decides not to exercise its license rights to any
Intellectual Property Right and so notifies Institution, it shall have no
further obligation to reimburse Institution for any costs incurred or accrued
subsequent to Institution's receipt of such notice, associated with the
preparation, filing, prosecution, issuance, or maintenance of any such
application(s) or any Intellectual Property Right obtained therefrom, and
Institution shall have the right to license such Intellectual Property Right to
any third party.
7.9 Prosecution Notice. With respect to any Intellectual Property Right
covering a particular Invention or Copyrightable Work made by Investigators,
including any Joint Invention or Joint Copyrightable Work filed by mutual
agreement of the Parties, Institution shall use its best efforts to provide to
deCODE, sufficiently prior to the filing of such application, response or
request to allow for review and comment by deCODE, each application and
communication to and from the authorities which grant such Intellectual Property
Right, including without limitation each application, office action, response to
office action, request for terminal disclaimer, request for reissue or
reexamination of any patent issuing from such application, and notice of
interference or opposition. Institution shall give due consideration to any
comments made by deCODE or its patent counsel on any of the foregoing.
7.10 Confidentiality. All information given to deCODE by Institution in
accordance with this Section 7 shall be held in confidence by deCODE for so long
as such information remains unpublished.
8. Licensing of Intellectual Property.
8.1 Licensing Rights. Subject to the provisions of 35 U.S.C. Sections 202
- 212, 64 F.R. Section 72,090 and 37 C.F.R. Sections 401 et seq. and regulations
pertaining thereto, Institution hereby grants to deCODE an exclusive option to
obtain an exclusive, worldwide right and license, with a right to grant
sublicenses, under Institution's rights in Intellectual Property Rights, as
follows: (a) if in Patent Rights (i) to make, import, use and sell products, and
(ii) to use and sell methods, or (b) if in Copyrightable Works, to use and sell
such Copyrightable Work, including the right to incorporate such Copyrightable
Work into any product or service. The exclusive option granted to deCODE to
obtain license rights to Intellectual Property Rights shall extend for a period
of one hundred eighty (180) days after the date of deCODE's receipt of written
disclosure by the Institution of an Invention or Copyrightable Work, including a
Joint Invention or Joint Copyrightable Work, covered by Institution's
Intellectual Property Rights. In the event that deCODE fails to exercise its
option to take the exclusive license within the one hundred eighty (180) day
period, deCODE shall have no further rights to such Intellectual Property Rights
and Institution's obligations to deCODE under this Agreement with regard to such
Intellectual Property Rights shall terminate.
8.2 License Terms. Upon the exercise of any option for an exclusive
license to any of Institution's Intellectual Property Rights by deCODE pursuant
to Section 8.1, deCODE and Institution shall enter into a License Agreement in
the form attached hereto as Appendix G. The royalty rate to be paid by deCODE to
Institution shall be determined by the Joint Steering
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Committee created by the Strategic Alliance Agreement or, if the Joint Steering
Committee is no longer in existence, by mutual agreement of the Parties, based
on the customary standards in agreements between academia and industry for the
Intellectual Property Rights being licensed which take into account: (a) the
type of product or services which shall be developed using such Invention or
Copyrightable Work (e.g., a therapeutic product, diagnostic product, diagnostic
service, research tool, etc.); (b) whether products or services shall embody
such Invention or Copyrightable Work covered by such Intellectual Property
Right; (c) the degree to which products or services shall embody such Invention
or Copyrightable Work covered by such Intellectual Property Right; (d) the
degree to which products or services shall contain active components or
technology not licensed from Institution under this License Agreement; (e)
whether the license is for an Invention or Copyrightable Work owned solely by
Institution, or is for a Joint Invention or Joint Copyrightable Work; (f) the
stage of development of the product or service at the time of licensing, and the
extent of the research and development required to create a commercializable
product or service; (g) potential sales volume and profitability of the products
or services; and (h) projected expenses to develop and market the products or
services. In the event that the Joint Steering Committee, or the Parties, as the
case may be, are not able to reach resolution of the appropriate royalty rate
within sixty (60) days after deCODE exercises its option for a license for a
particular Intellectual Property Right, the Parties shall submit such matter to
a "short-form" arbitration proceeding, using "baseball" principles (in other
words, each Party shall submit a definitive position to the arbitrator(s), who
shall be instructed that such arbitrator(s) must select one of the positions
submitted to represent the final determination), to make a final determination.
The arbitrator(s) selected to conduct a "short-form" arbitration shall be
knowledgeable and experienced in the pharmaceutical industry.
8.3 Waiver of License Rights. The option to acquire a license to
Intellectual Property Rights hereunder shall not apply to any Intellectual
Property Right to which deCODE has waived its rights pursuant to Sections 7.6 or
7.8 of this Agreement.
8.4 Effect of License on Section 7. Upon the execution of a License
Agreement by the Parties with respect to any Invention or Copyrightable Work,
and any Intellectual Property Right covering such Invention or Copyrightable
Work, all rights and obligations of the Parties with respect to such
Intellectual Property Rights, including without limitation IP Costs, incurred on
or after the date of such execution, shall be governed by the terms of such
License Agreement.
8.5 Contractual Obligations to Other Sponsors. To the extent and only to
the extent that Institution is prohibited from granting to deCODE an exclusive
license to Institution's interest in any Patent Rights or Copyrightable Work due
to any contractual obligation of Institution requiring it to license
Institution's interest in such Patent Rights or Copyrightable Work to any other
sponsor of research (including, without limitation, any provider of biological
materials) with respect to an Invention made jointly by a person who is not an
Investigator but who is a co-inventor of a Patent Right or Copyrightable Work
with an Investigator, and provided that such other sponsor is bound by a
provision similar to this Section 8.5 with respect to such Patent Right or
Copyrightable Work, then:
8.5.1 Any license granted to deCODE under a License Agreement
pursuant to
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this Agreement shall be co-exclusive with such other sponsor with respect to
such Patent Right or Copyrightable Work; and
8.5.2 Any royalty to be paid on products covered by such Patent
Right or Copyrightable Work shall be the lesser of: (a) [CONFIDENTIAL TREATMENT
REQUESTED]; or (b) [CONFIDENTIAL TREATMENT REQUESTED].
9. Budget.
9.1 Payments. deCODE agrees to support this Study in an amount up to
$________________, including direct and indirect costs, as set forth in the
Budget and Payment Schedule attached hereto as Appendix D. Such funds shall be
used to support the direct and attendant indirect costs (as determined by
Institution's policies on indirect cost, as communicated to deCODE from time to
time) of the Study. All of such funding of direct costs shall be used by
Institution as deemed necessary and appropriate by the Principal Investigator to
carry out the Study and achieve the research goals and objectives set forth in
Appendix A.
9.2 Payment Method. Checks should be made payable to " "
and sent, along with a letter indicating the name of the Principal Investigator
and the specific Clinical Trial Agreement for which the funds are intended, to:
Financial Control Coordinator
Research Finance
______________________________
______________________________
______________________________
______________________________
9.3 Payment Records; Audit Rights. Institution shall maintain records of
its expenditures and of funds received under this Agreement in accordance with
its customary accounting policies and procedures and shall provide to deCODE a
summary of such expenditures within ninety (90) days after the end of each
elapsed year during the Term. During the Term and for two years thereafter,
deCODE on reasonable notice, during normal business hours and at its own expense
may examine or audit Institution's accounting records with respect to
expenditures under this Agreement, provided, however, that in the event that
such inspection or audit reveals an overpayment by deCODE in excess of five
percent (5%) of the amount actually due for the period subject to such audit or
examination, Institution shall reimburse the cost of the examination or audit in
addition to refunding the excess payment.
10. Use of Name.
No Party shall, without the prior written consent of the other Party, use
in endorsement, advertising, publicity, or otherwise, the name, trademark, logo,
symbol, or other image of the other Party or such Party's employees or agents.
Each Party agrees that its name may be used:
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(a) whenever required by law or regulation, including without limitation
disclosure to the Securities and Exchange Commission, provided, however, that a
Party using another Party's name shall, to the extent reasonably practicable as
solely determined by such using Party, provide a copy of such proposed
disclosure to such other Party in advance and give consideration to such other
Party's comments and requests regarding such disclosure, but shall not be
obligated to perform any act or omission in response to such comments or
requests; (b) by deCODE in connection with its capital raising and financing
purposes, based upon standard agreed-to statements; (c) to make a joint,
mutually agreeable public announcement about the initiation of the relationship
and the support of the Study hereunder; and (d) to make routine acknowledgments
of the relationship, support of the Study hereunder and the basic substance of
the relationship, based upon standard agreed-to statements. If no such standard
statements have been established, then the disclosing Party shall provide the
non-disclosing Party with an opportunity to review, comment on and approve the
disclosure in advance of making such disclosure. Nothing in this Section 10
shall abridge any Party's rights with respect to use of the other Party's name
under any other valid agreement, including the Strategic Alliance Agreement, any
Sponsored Research Agreement, the Crosswalk Development Agreement, or any
Software License Agreement.
11. Study Records.
Institution shall make Study records available to deCODE representatives
upon request for comparison with case report forms. Any audits conducted by
deCODE shall be undertaken in conjunction with Institution and pursuant to
guidelines established from time to time by Institution in order to assure
patient confidentiality. Institution shall also make such records available upon
reasonable request for review by representatives of the U.S. Food and Drug
Administration. Institution shall retain records of the Study including either
the original or a copy of all volunteer consent forms in conformance with
applicable federal regulations.
12. Term and Termination.
12.1 Term. The term of this Agreement shall be until the completion of the
Study, which is anticipated to be ___ (_) year from the Effective Date, unless
terminated in accordance with Section 12.2 through 12.5 (the "Term").
11.2. Breach by deCODE. If deCODE fails to meet any of its material
obligations under this Agreement and shall fail to remedy these failures within
sixty (60) days after receipt of written notice thereof, Institution shall have
the option of terminating this Agreement upon written
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notice thereof; provided, however, that deCODE shall have the right to cure such
default during such sixty (60) day period. In the event of such a termination of
this Agreement, deCODE shall have no further option rights to any Intellectual
Property Rights created in the Study after the date of such termination.
12.3 Breach by Institution. If Institution fails to meet any of its
material obligations under this Agreement and shall fail to remedy these
failures within sixty (60) days after receipt of written notice thereof, deCODE
shall have the option of terminating this Agreement upon written notice thereof;
provided, however, that Institution shall have the right to cure such default
during such sixty (60) day period.
12.4 Termination by deCODE for Infeasibility. In the event that deCODE
determines that the Research is scientifically or economically not feasible or
no longer is consistent with deCODE's business strategy, deCODE may terminate
this Agreement at any time during the Term by giving written notice of
termination to Institution ten (10) days prior to the effective date of such
termination.
12.5 Termination of Strategic Alliance Agreement. In the event that the
Strategic Alliance Agreement is terminated by deCODE pursuant to Section 10.5
thereof, and as a result thereof deCODE elects to terminate this Agreement
pursuant to Section 10.5 thereof, then this Agreement shall also be deemed to be
terminated ten (10) days after deCODE provides the Institution notice thereof as
provided in Section 10.5 of the Strategic Alliance Agreement. In the event that
the Strategic Alliance Agreement is terminated pursuant to Section 10.5, but
this Agreement is not terminated, then the JSC shall continue to exist for the
purposes provided in this Agreement, pursuant to the terms governing the JSC as
provided in the Strategic Alliance Agreement.
12.6 Effect of Termination.
12.6.1 In the event that this Agreement is terminated by Institution
pursuant to Section 12.2 or 13.2.2, by deCODE pursuant to Section 2.4 or 12.4,
or by deCODE pursuant to Section 12.5 following a deCODE Notice under the
Strategic Alliance Agreement, Institution shall use all reasonable efforts to
immediately commence winding down the Study and to terminate or cancel all
contractual commitments and other financial obligations as soon as possible to
avoid incurring additional expenses. deCODE shall reimburse Institution for
contractual commitments and financial obligations incurred by Institution during
the Term if such financial obligations or contractual commitments cannot
reasonably be cancelled by Institution, and, in addition, shall reimburse to
Institution the direct salary costs incurred by Institution, for a period of six
months after the effective date of such termination, of any M.D. or Ph.D. who,
during the three (3) month period preceding the notice of termination, is
deriving 50% or more of his or her salary from the Study funded by deCODE.
12.6.2 In the event that this Agreement is terminated by deCODE
pursuant to Section 12.3 or by deCODE pursuant to Section 12.5 following an
Institution Notice under the Strategic Alliance Agreement, all funding
obligations of deCODE shall cease as of the effective date of such termination.
12.7 Return of Confidential Information and Materials. In the event that
this Agreement is terminated by either Party pursuant to Section 2.4, 12.2,
12.3, 12.4, 12.5 or 13.2.2, each Party shall return to the other its
Confidential Information, unused Materials and Study [DRUG/DEVICE] and Patient
Tissues, if any; provided, however, that one copy of such other Party's
Confidential Information maybe retained for such returning Party's legal
archives.
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13. Indemnification and Insurance.
13.1 Indemnification.
12.1.1 deCODE shall indemnify, defend and hold harmless Institution
and Approved Subcontractees and its/their respective trustees, officers, medical
and professional staff, employees, and agents and their respective successors,
heirs and assigns (the "Indemnitees"), against any liability, damage, loss or
expense (including reasonable attorney's fees and expenses of litigation)
incurred by or imposed upon the Indemnitees or any one of them in connection
with any claims, suits, actions, demands or judgments arising out of any side
effect, adverse reaction, illness, or injury occurring to any person as a result
of his or her involvement in the Study.
13.1.2 deCODE's indemnification under Section 13.1.1 shall not apply
to any liability, damage, loss or expense to the extent that it is directly
attributable to: (a) the negligent activities, reckless misconduct or
intentional misconduct of the Indemnitees; or (b) failure of the Indemnitees to
adhere to the terms of the protocol for the Study.
13.1.3 deCODE agrees, at its own expense, to provide attorneys
reasonably acceptable to Institution to defend against any actions brought or
filed against any Party indemnified hereunder with respect to the subject of the
indemnity contained herein, whether or not such actions are rightfully brought.
13.1.4 deCODE also agrees to reimburse Institution for the costs of
the care and treatment of any illness or injury to a subject resulting from his
or her participation in the Study to the extent that such costs are not covered
by the subject's medical or hospital insurance or governmental programs
providing such coverage.
13.2 Insurance.
13.2.1 deCODE shall, at its sole cost and expense, procure and
maintain commercial general liability insurance or equivalent self-insurance in
amounts not less than [CONFIDENTIAL TREATMENT REQUESTED] per incident and
[CONFIDENTIAL TREATMENT REQUESTED] annual aggregate. Such commercial general
liability insurance or equivalent self-insurance shall provide contractual
liability coverage for deCODE's indemnification under Section 13.1 of this
Agreement.
13.2.2 deCODE shall, at Institution's request, provide Institution
with written evidence of such insurance. deCODE shall provide Institution with
written notice at least fifteen (15) days prior to the cancellation, non-renewal
or material change, in such insurance; if deCODE does not obtain replacement
insurance providing comparable coverage within such fifteen (15) day period,
Institution shall have the right to terminate this Agreement effective at the
end of such fifteen (15) day period without notice of any additional waiting
periods.
14. Debarment.
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Institution warrants that neither Institution nor the Principal
Investigator is debarred under subsections 306(a) or (b) of the Generic Drug
Enforcement Act of 1992, nor shall the services of any person knowingly be used
in any capacity in the performance of this Agreement who is or becomes debarred
under the aforementioned statute. Should the Principal Investigator or any such
aforementioned person become debarred, Institution shall immediately notify
deCODE.
15. Financial Disclosure.
Principal Investigator and any Investigators performing efficacy or safety
evaluations shall, at the request of deCODE, provide deCODE with any and all
financial information required to be disclosed pursuant to 21 C.F.R. Part 54
with respect to themselves as well as their spouses and dependent children. Such
financial information shall be disclosed on a form to be provided by deCODE
completed by Principal Investigator and any Investigators.
16. Alternative Dispute Resolution.
16.1 Negotiation. The Parties shall attempt in good faith to resolve,
through negotiation, any dispute, claim or controversy arising out of or
relating to this Agreement. Either Party may initiate negotiations by providing
written notice in letter form to the other Party, setting forth the subject of
the dispute and the relief requested. The recipient of such notice shall respond
within five (5) days with a written statement of its position on, and
recommended solution to, the dispute. If the dispute is not resolved by this
exchange of correspondence, then representatives of each Party with full
settlement authority shall meet at a mutually agreeable time and place within
ten (10) days of the date of the initial notice in order to exchange relevant
information and perspectives, and to attempt to resolve the dispute.
16.2 Arbitration. Except with respect to breaches for which a Party is
seeking injunctive relief, all disputes between the Parties relating to this
Agreement or the subject matter hereof which cannot be resolved by the Parties
according to Section 16.1, shall be submitted for final and binding arbitration
before JAMS/Endispute ("JAMS") pursuant to the United States Arbitration Act, 9
U.S.C. Section 1 et seq., and shall be held at a mutually agreeable location or
in New York City. Either Party may commence the arbitration process pursuant to
this Agreement by filing a written demand for arbitration with JAMS, with a copy
to the other Party. Unless the Parties otherwise agree in writing, the
arbitration shall be conducted in accordance with the provisions of JAMS
Comprehensive Arbitration Rules and Procedures in effect at the time of filing
of the demand for arbitration if the amount in controversy is greater than
$250,000, exclusive of interest; or the arbitration shall be conducted in
accordance with the provisions of JAMS Streamlined Arbitration Rules and
Procedures in effect at the time of filing of the demand for arbitration, if the
amount in controversy is $250,000 or less, exclusive of interest. In the event
of a dispute over royalty rates, the arbitration shall be conducted as set forth
in Section 8.2. The Parties shall cooperate with JAMS and with one another in
selecting an arbitrator from JAMS' panel of neutrals, and in scheduling the
arbitration proceedings; provided, however, that all arbitrators must be
knowledgeable in the pharmaceutical industry and must not be affiliated through
employment or otherwise with a competitor of either Party, as determined through
mutual assent of the Parties. The Parties shall participate in the arbitration
in good faith, and shall
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share equally in its costs. The provisions of this Section may be enforced by
any Court of competent jurisdiction, and the Party seeking enforcement shall be
entitled to an award of all costs, fees and expenses, including attorneys fees,
to be paid by the Party against whom enforcement is ordered.
16.3 Injunction. This Section 16 shall not prohibit a Party from seeking
injunctive relief from a court of competent jurisdiction in the event of a
breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
17. Miscellaneous.
17.1 Governing Law. This Agreement shall be interpreted in accordance
with, and governed by, the laws of the State of Delaware, not including its
conflict of interest laws.
17.2 Independent Contractors. deCODE shall not have the right to direct or
control the activities of Institution or any Investigators in performing the
Study and Institution shall act hereunder only as an independent contractor;
nothing herein contained shall be construed to be inconsistent with that
relationship or status. Under no circumstances shall Institution or any
Investigator be considered to be an employee or agent of deCODE. This Agreement
shall not constitute, create, or in any way be interpreted as a joint venture,
partnership or formal business organization of any kind.
17.3 Assignment. Neither Party shall assign its rights or duties under
this Agreement to another without the prior express written consent of the other
Party, which consent shall not be unreasonably withheld; provided, however, that
either Party may assign this Agreement to a successor in ownership of all or
substantially all its business assets. Such successor shall expressly assume in
writing the obligation to perform in accordance with the terms and conditions of
this Agreement.
17.4 Notices. All notices, demands and other communications of every kind
and description whatsoever required or permitted under this Agreement shall be
in writing and shall be deemed to have been received when personally delivered,
or when shipped by private express carrier (signature required), shipment
charges prepaid, or when sent via facsimile transmission (receipt verified) to
the Party to whom delivery shall be made at the respective addresses as set out
below.
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If to Institution, to:
___________________________________________
Corporate Sponsored Research and Licensing
Attn: Director, Corporate Sponsored Research and Licensing
Institution Agreement #________
cc: Institution's representative on Joint Steering Committee
Telephone:
Facsimile:
If to deCODE, to:
deCODE genetics Ltd.
Xxxxxxxxx 0
XX-000 Xxxxxxxxx, Xxxxxxx
Attn:
Telephone: x000-000-0000
Facsimile: x000-000-0000
17.5 Modification. No modification or waiver of this Agreement or of any
covenant, condition, or limitation herein contained shall be valid unless in
writing and duly executed by both Parties.
17.6 Waiver. No waiver of any rights shall be effective unless assented to
in writing by the Party to be charged and the waiver of any breach or default
shall not constitute a waiver of any other right hereunder or any subsequent
breach or default.
17.7 Headings. The Section headings herein are for convenience only and
shall not affect the construction or interpretation of this Agreement.
17.8 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and effect
without said provision; provided, however, that no such severability shall be
effective if the result of such action materially changes the economic benefit
of this Agreement to deCODE or to Institution.
17.9 Construction. The Parties have participated equally in the creation
of this Agreement; the language of this Agreement shall not be presumptively
construed against either Party.
17.10 Survival. The provisions of Sections 1, 4, 5, 6, 7, 8, 9.3, 10, 11,
12.6, 12.7, 13, 14, 15, 16, 17.1, 17.8, 17.9 and 17.10 shall survive any
expiration or termination of this Agreement.
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17.11 Counterparts. This Agreement may be executed in counterparts, each
of which shall constitute an original document, but all of which together shall
constitute one and the same instrument.
* * *
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In witness whereof, Institution and deCODE have caused this Agreement to
be executed by their duly authorized representatives as of the date first set
forth above.
INSTITUTION: DECODE GENETICS LTD.:
BY: __________________________ BY: ____________________________
NAME: __________________________ NAME: ____________________________
TITLE: __________________________ TITLE: ____________________________
DATE: __________________________ DATE: ____________________________
Acknowledged and Agreed:
________________________________ ____________________________________
Principal Investigator Date
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APPENDIX A
STUDY PROTOCOL
(see attached)
000
XXXXXXXX X
CONFIDENTIAL DECODE STUDY DATA
List deCODE Study Data which the Parties and the Principal Investigator agree
are to be treated as deCODE's Confidential Information, in accordance with
Section 5 of this Agreement:
Term of confidentiality (check one):
___ Ten (10) years from the Effective Date; or
___ Until _____________________(event or date)
INSTITUTION: DECODE GENETICS LTD.
BY: ____________________________ BY: ____________________________
NAME: ___________________________ NAME: ____________________________
TITLE: ___________________________ TITLE: ____________________________
DATE: ____________________________ DATE: ____________________________
PRINCIPAL INVESTIGATOR:
____________________________ DATE: ____________________________
118
APPENDIX C
FORM OF LICENSE AGREEMENT
(see attached)
119
APPENDIX D
BUDGET AND PAYMENT SCHEDULE
(see attached)
000
XXXXXXXX X
LIST OF INTELLECTUAL PROPERTY RIGHTS
(to be prepared and updated from time to time)
INSTITUTION: DECODE GENETICS LTD.
BY: ____________________________ BY: ____________________________
NAME: ___________________________ NAME: ____________________________
TITLE: ___________________________ TITLE: ____________________________
DATE: ____________________________ DATE: ____________________________
121
APPENDIX F
FORM OF TRANSFER LETTERS
(see attached)
122
TRANSFER LETTER
(Institution to deCODE)
Effective Date:__________________
This Transfer Letter confirms deCODE's desire to obtain Institution Materials,
subject to the terms and conditions of the Clinical Trial Agreement between
deCODE and Institution dated __________________.
Institution Materials to be transferred:
Institution Materials shall include any replicates, progeny, unmodified
derivatives and any parts of the foregoing incorporated in modifications. All
title and intellectual property rights in Institution Materials are and shall be
owned solely by Institution.
Proposed use of the Institution Materials listed above:
For Institution: Acknowledged by
Principal Investigator:
For deCODE:
Please send fully-executed original of this Transfer Letter, referencing
Agreement # XXXX, to: Corporate Sponsored Research and Licensing,
[INSTITUTION ADDRESS]
123
TRANSFER LETTER
(deCODE to Institution)
Effective date:_________________
This Transfer Letter confirms Institution's desire to obtain deCODE Materials,
subject to the terms and conditions of the Clinical Agreement between deCODE and
Institution dated __________________.
deCODE Materials to be transferred:
deCODE Materials shall include any replicates, progeny, unmodified derivatives
and any parts of the foregoing incorporated in modifications. All title and
intellectual property rights in deCODE Materials are and shall be owned solely
by deCODE.
Permitted use of the deCODE Materials listed above:
For deCODE:
For Institution: Acknowledged by
Principal Investigator:
Please send fully-executed original of this Transfer Letter, referencing
Agreement # XXXX, to: Corporate Sponsored Research and Licensing,
[INSTITUTION ADDRESS]
124
APPENDIX G
FORM OF TRANSFER AGREEMENT FOR PATIENT TISSUE SAMPLES
125
TRANSFER AGREEMENT FOR PATIENT TISSUE SAMPLES
This Agreement is made as of xxxxxxxxxxxx between xxxxxxxxxxxxxx, a
corporation having a principal place of business at
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ("deCODE"), and [Partners Institution],
having a place of business at xxxxxxxxxxxxxxxxxxxx, ("Institution").
1. Institution shall make available to deCODE, through Dr. xxxxxxxxxxx and
other Institution personnel working under his or her direction (collectively,
the "Investigators"), the following patient tissue samples (the "Samples"):
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
2. The Samples shall be used only under deCODE's immediate and
direct control for the internal, laboratory research or clinical trial purposes
set forth below (the "Project"):
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
-------------------------------------------------------------------. The Samples
shall not be used for any other purpose, including, without limitation, in any
research involving human subjects, in any product for commercial use or
distribution, or for the purpose of producing any product or for providing any
service, which product or service is sold or otherwise made commercially
available. No other right or license, to a patent or otherwise, is granted to
deCODE for the use of the Samples as a result of Institution's transmission of
them to deCODE.
3. IT IS UNDERSTOOD THAT INVESTIGATORS SHALL NOT PROVIDE TO DECODE ANY
PATIENT IDENTIFYING INFORMATION OR "PERSONAL DATA" (AS DEFINED IN MASSACHUSETTS
LAW, C. 66A) INCLUDING MEDICAL RECORDS AND PEER REVIEW DATA ("INFORMATION").
HOWEVER, IF IN THE COURSE OF THIS AGREEMENT, DECODE IS PROVIDED, OBTAINS OR HAS
ACCESS TO SUCH INFORMATION, DECODE SHALL RETURN IT IMMEDIATELY AND SHALL NOT
USE, PUBLISH OR DISCLOSE SUCH INFORMATION IN ANY MANNER WHATSOEVER. DECODE SHALL
COMPLY WITH THE LAWS AND REGULATIONS OF THE COMMONWEALTH OF MASSACHUSETTS AND
APPLICABLE FEDERAL LAWS AND REGULATIONS RELATING TO THE CONFIDENTIALITY AND
PRIVACY OF SUCH INFORMATION. DECODE AGREES TO NOTIFY INSTITUTION AND
INVESTIGATORS ORALLY AND IN WRITING WITHIN TWENTY-FOUR (24) HOURS OF ITS
DISCOVERY OF ANY INFORMATION IN ITS POSSESSION WHICH IS IMPROPERLY USED, COPIED,
OR REMOVED BY ANYONE EXCEPT AN AUTHORIZED REPRESENTATIVE OF INSTITUTION OR
DECODE. DECODE SHALL COOPERATE WITH INSTITUTION AND INVESTIGATORS IN TAKING SUCH
STEPS AS ARE DEEMED APPROPRIATE BY INSTITUTION TO ENJOIN THE MISUSE, REGAIN
POSSESSION OF THE INFORMATION, AND OTHERWISE PROTECT INSTITUTION'S RIGHTS AND
PATIENTS' PRIVACY.
4. deCODE shall be responsible for all costs, insurance and liability
relating to processing and shipment of the Samples from Institution's place of
business, and for arranging for shipment if necessary.
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5. The Samples are transferred AS IS, WITHOUT WARRANTY OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR ANY OTHER WARRANTY, INCLUDING SAFETY. THE SAMPLES HAVE NOT
BEEN ANALYZED OR TESTED BY INSTITUTION AND MAY, THEREFORE, CONTAIN VIRUSES,
BACTERIA OR OTHER POTENTIALLY DANGEROUS COMPONENTS. DECODE ACKNOWLEDGES AND
ACCEPTS THE RISKS OF SUCH VIRUSES, BACTERIA OR OTHER POTENTIALLY DANGEROUS
COMPONENTS. INSTITUTION MAKES NO REPRESENTATION OR WARRANTY THAT THE USE OF THE
SAMPLES WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
6. deCODE shall treat the Samples as infectious, biomedical and
biohazardous material, and shall abide by all federal, state and local laws and
regulations concerning their packaging, storage, labeling, handling, testing,
transportation, use and disposal.
7. Upon completion of the Project or upon termination of this Agreement by
either party for any reason upon 30 days' written notice to the other, deCODE
agrees to discontinue use of the Samples and to arrange for the return to
Institution or the lawful disposal (and provide written certification of same)
of all unused Samples in accordance with Paragraph 6.
8. Institution and deCODE shall each indemnify and shall hold the other
harmless for any injury to persons or damage to property to the extent that such
injury or damage is caused by the negligence or willful misconduct of their
employees or staff based on or arising out of the packaging, storage, labeling,
handling, testing, transfer, transportation, use or disposal of the Samples;
provided however, that deCODE shall defend, indemnify, and hold harmless
Institution and its trustees, employees and staff against any and all actions,
suits, claims, demands or prosecutions that may be brought or instituted against
Institution and/or its trustees, employees and staff based on or arising out of
or connected with deCODE's licensees' packaging, storage, labeling, handling,
testing, transfer, transportation, use or disposal of the Samples.
AGREED AND ACCEPTED:
deCODE [PARTNERS INSTITUTION]
By: _______________________ By: __________________________
Title: _______________________ Title: __________________________
Date: _______________________ Date: __________________________
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[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.]
LICENSE AGREEMENT
BETWEEN
[NAME OF INSTITUTION]
AND
DECODE GENETICS LTD.
DATED ____________, 2000
128
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "Agreement"), effective
______________ ___, 2000 (the "Effective Date") between [name of Partners'
Institution] ("Institution") (for example, The General Hospital Corporation
d.b.a. Massachusetts General Hospital, a Massachusetts not-for-profit
corporation having its principal offices at 00 Xxxxx Xxxxxx, Xxxxxx, XX 00000 or
The Xxxxxxx and Women's Hospital, Inc., a Massachusetts not-for-profit
corporation having its principal offices at 00 Xxxxxxx Xxxxxx, Xxxxxx, XX
00000), or Partners HealthCare System, Inc.) and deCODE genetics Ltd., an
Icelandic corporation which is a wholly-owned subsidiary of deCODE genetics,
Inc., a Delaware corporation, and having its principal offices at Xxxxxxxxx 0,
XX-000 Xxxxxxxxx, Xxxxxxx ("deCODE") (Institution and deCODE, each a "Party" and
collectively, the "Parties").
BACKGROUND
Under research programs funded by deCODE pursuant to that certain [SPONSORED
RESEARCH AGREEMENT, DATED AS OF ______________________, 2000 (THE "SPONSORED
RESEARCH AGREEMENT"), OR CLINICAL TRIAL AGREEMENT, DATED AS OF
______________________, 2000 (THE "CLINICAL TRIAL AGREEMENT")], the Institution
through research conducted by Dr. has developed an invention pertaining
to . The Institution is preparing a U.S. Patent Application covering said
invention and all Dr. 's rights, title and interest in said application
have been assigned to Institution. As a center for research and education,
Institution is interested in licensing Patent Rights and thus benefiting the
public and the Institution by facilitating the dissemination of the results of
its research in the form of useful products, but is without capacity to
commercially develop, manufacture, and distribute any such product. deCODE
having such capacity, desires to commercially develop, manufacture, use and
distribute such products throughout the world.
The Parties have, therefore, agreed as follows:
1. Definitions.
1.1 "Accounting Period" shall mean each six-month period ending June 30
and December 31.
1.2 "Combined Product" shall have the meaning assigned to such term in
Section 5.5.
1.3 "Competitive" shall have the meaning assigned to such term in
Section 9.7.5.
1.4 "Costs" shall have the meaning assigned to such term in Section
4.1.
1.5 "Customer" shall have the meaning assigned to such term in Section
1.17.
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1.6 "deCODE" shall have the meaning assigned to such term in the
Introductory section.
1.7 "deCODE Indemnitees" shall have the meaning assigned to such term
in Section 8.1.2.
1.8 "Effective Date" shall have the meaning assigned to such term in
the Introductory section.
1.9 "First Commercial Sale" shall mean in each country the first sale
of any Product by deCODE or its Sublicensees.
1.10 "Indemnitee" shall have the meaning assigned to such term in
Section 8.1.3.
1.11 "Institution" shall have the meaning assigned to such term in the
Introductory Section.
1.12 "Institution Indemnitees" shall have the meaning assigned to such
term in Section 8.1.1.
1.13 "Inventors" shall mean those members of the Institution's
professional staff, graduate students, undergraduate students or employees of
Institution who contributed to the invention covered by the Patent Rights.
1.14 "JAMS" shall have the meaning assigned to such term in Section
11.2.
1.15 "Joint Patent Rights" shall have the meaning assigned to such term
in Section 4.5.
1.16 "License Field" shall mean.
1.17 [NOTE: THIS DEFINITION IS TO BE CUSTOMIZED BASED ON THE NATURE OF
THE LICENSED TECHNOLOGY AND LIKELY PRODUCTS OR SERVICES TO BE SOLD.] "Net Sales
Price" shall be with respect to any Product, the gross amount invoiced for such
Product by deCODE to Third Parties other than deCODE and its Sublicensees
("Customer"), less deductions for: (a) trade, quantity and/or cash discounts,
allowances and rebates (including, without limitation, promotional allowances or
discounts or similar allowances) actually allowed or given; (b) freight,
postage, shipping, insurance and transportation expenses and similar charges (in
each instance, if separately identified in such invoice); (c) credits or refunds
actually allowed for rejections, defects or recalls of such Product, outdated or
returned Product, or because of rebates or retroactive price reductions; and (d)
sales, value-added and excise taxes, tariffs and duties, and other taxes
directly related to the sale, to the extent that such items are included in the
gross invoice price (but not including taxes assessed against the income derived
from such sale). Such amounts shall be determined from the books and records of
deCODE, maintained in accordance with the reasonable accounting principles used
by such entity, consistently applied. Transfer of a Product within deCODE or
between deCODE and
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a Sublicensee for sale by the transferee shall not be considered a sale,
commercial use or disposition for the purpose of the foregoing Sections; in the
case of such transfer the Net Sales Price shall be based on sale of the Product
by the transferee.
1.18 "Party" or "Parties" shall have the meanings assigned to such
terms in the Introductory paragraph.
1.19 "Patent Rights" shall mean the U.S. Patent Application to be filed
by Dr. entitled , Serial No. ________________ or the equivalent of
such application, including any division, continuation or any corresponding
foreign patent application or Letters Patent or the equivalent thereof issuing
thereon or reissue, reexamination or extension thereof. Patent Rights shall also
include those claims in any continuation-in-part of the aforementioned patent
application which claim an invention described or claimed in patent application
Serial No._________________.
1.20 "Product" shall mean any method, procedure, product, or component
part thereof whose manufacture, sale, importation, or use includes any use of
Technological Information that is covered by any Valid Claim included in the
Patent Rights.
1.21 "Sublicensee" shall mean any Third Party licensed by deCODE to
make, have made, use or sell any Product. As used in this Agreement,
"Sublicensee" shall include any Third Party to whom deCODE has granted, directly
or indirectly, the right to distribute a Product, provided that such Third Party
has the responsibility in whole or in part for marketing and/or promotion of the
Product within the territory for which such distribution rights are granted.
1.22 "Sublicensing Income" shall have the meaning assigned to such term
in Section 5.3.
1.23 "Technological Information" shall mean any unpublished research
and development information, unpatented inventions, and unpublished clinical
data and technical data known to the Inventors in the possession of the
Institution prior to the Effective Date which relates to and is necessary for
the practice of the inventions claimed in the Patent Rights and which the
Institution is not prohibited from disclosing to deCODE pursuant to the
agreement under which such information or data was created.
1.24 "Third Party" shall mean any party other than a Party.
1.25 "Valid Claim" shall mean either: (a) a claim of an issued and
unexpired patent included in the Patent Rights, which has not been held
permanently revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, which decision is unappealable or
unappealed within the time allowed for appeal, and which claim has not been
admitted to be invalid or unenforceable through reissue or disclaimer or
otherwise; or (b) a pending claim of a pending patent application that is
classified under this Agreement as a Patent Right, which claim (i) was filed in
good faith, (ii) is reasonably likely to issue, (iii) has not been
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abandoned or finally disallowed without the possibility of appeal or
refining of said application, and (iv) has not been pending for a period in
excess of five (5) years from the earliest date from which the patent
application was filed or claims priority in such country unless such application
is the subject of an appeal, interference or opposition being prosecuted with
the consent of deCODE.
2. License.
2.1 Grant. Institution hereby grants deCODE, subject to the terms and
conditions of this Agreement:
2.1.1 The exclusive (even as to Institution), worldwide right
and license, under the Patent Rights, to develop, make, have made, use, import,
export, lease, offer to sell, sell, have sold and otherwise exploit Products in
the License Field, and to grant, offer for sale and authorize sublicenses with
respect to the right and license granted under this Section 2.1.1 to Third
Parties; and
2.1.2 A non-exclusive perpetual license, with the right to
sublicense, to use Technological Information for any purpose that does not
infringe any patent owned, in whole or in part, by Institution that is not
expressly licensed to deCODE.
2.2 Exceptions. It is understood that the granting of any exclusive
license hereunder is subject to Institution's right to make and to use the
subject matter described and claimed in any Patent Rights for non-commercial
internal research, clinical and educational purposes, but not for any commercial
or other non-commercial purpose, and that if federal funding supported such
Patent Rights, deCODE's license will be subject to the rights, conditions and
limitations imposed by U.S. law, including without limitation the royalty-free
non-exclusive license granted to the U.S. government (see 35 U.S.C. Section 202
et seq. and regulations pertaining thereto; see also Principles and Guidelines
for Sharing of Biomedical Research Resources, 64 F.R. 72,090 and FARS 27.4).
2.3 Disclosure of Technological Information. Within thirty (30) days of
the Effective Date, upon request by deCODE, Institution shall disclose
Technological Information to deCODE.
2.4 Off-Label Usage. In the event that, at any time during the term of
this Agreement, Institution intends to offer to a Third Party any rights in any
Patent Rights or Technological Information outside of the Licensed Field or
receives an offer from a Third Party to acquire any such rights, Institution
shall notify deCODE of such offer. deCODE shall have sixty (60) days from
receipt of such notification to determine in good faith whether the grant of
such rights presents a reasonable risk of off-label usage in the Licensed Field
in which deCODE is developing, or has developed, a Product. In the event that
deCODE determines in good faith that the grant of such rights presents a
reasonable risk of off-label usage in the Licensed Field in which deCODE is
developing, or has developed, a Product, it shall have the right of first
refusal to accept such rights on terms no less favorable to Institution than
those last offered by such Third Party. In the event that deCODE desires to
exercise its right to acquire such rights, it shall notify Institution of its
determination within such sixty (60) day period, whereupon Institution shall
grant
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such rights to deCODE on terms no less favorable to Institution than those last
offered by such Third Party, and shall not grant such rights to the Third Party.
In the event that deCODE determines that the offer does not present a reasonable
risk of such off-label usage, or fails to notify Institution of its
determination to acquire such rights within the sixty (60) day period,
Institution shall have the unrestricted right to grant such rights to such Third
Party. In the event that deCODE determines that the offer does present a
reasonable risk of such off-label usage, but the Parties fail to reach a
mutually acceptable agreement for deCODE to acquire such rights within the sixty
(60) day period, the Parties shall negotiate the terms of a mechanism to
compensate deCODE for such off-label usage and Institution shall have the right
to grant such rights to such Third Party, subject to such compensation
mechanism.
2.5 Construction of Grant. It is understood that nothing herein shall
be construed to grant deCODE a license express or implied under any patent owned
solely or jointly by Institution other than the Patent Rights expressly licensed
hereunder.
3. Due Diligence Obligations.
3.1 Commercialization. deCODE shall itself, or through its
Sublicensees, use commercially reasonable efforts to develop and make
commercially available Products for commercial sales and distribution throughout
the world in the License Field.
[3.2 DILIGENCE MILESTONES. IN THE CASE OF DECODE, THE COMMERCIALIZATION
EFFORTS TO BE MADE PURSUANT TO SECTION 3.1 SHALL CONSIST OF ACHIEVING THE
FOLLOWING OBJECTIVES WITHIN THE TIME PERIOD DESIGNATED BELOW FOLLOWING THE
EFFECTIVE DATE:
3.2.1 WITHIN ( ) YEARS, [CONFIDENTIAL TREATMENT REQUESTED]
3.2.2 WITHIN ( ) YEARS, [CONFIDENTIAL TREATMENT REQUESTED]; AND
3.2.3 WITHIN ( ) YEARS, [CONFIDENTIAL TREATMENT REQUESTED]; OR
3.2.4 SUCH OTHER MILESTONES AS THE PARTIES AGREE ARE APPROPRIATE FOR
THE PARTICULAR PRODUCT.
PROVIDED, HOWEVER, THAT INSTITUTION SHALL NOT UNREASONABLY WITHHOLD ITS CONSENT
TO ANY REVISION IN SUCH TIME PERIODS WHENEVER REQUESTED IN WRITING BY DECODE AND
SUPPORTED BY EVIDENCE OF TECHNICAL DIFFICULTIES OR DELAYS IN CLINICAL STUDIES OR
REGULATORY PROCESSES THAT THE PARTIES COULD NOT HAVE REASONABLY AVOIDED. FAILURE
TO ACHIEVE ONE OR MORE OF THE ABOVE OBJECTIVES WITHIN THE ABOVE STATED TIME
PERIODS OR WITHIN ANY EXTENSION GRANTED BY INSTITUTION SHALL RESULT IN
INSTITUTION HAVING THE RIGHT TO CANCEL UPON THIRTY (30) DAYS NOTICE ANY
EXCLUSIVE LICENSE GRANTED HEREUNDER.
OR, IN LIEU OF MILESTONES, THE PARTIES MAY AGREE TO PROVIDE:
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3.2 ANNUAL MINIMUM ROYALTIES. IN THE CASE OF DECODE, THE
COMMERCIALIZATION EFFORTS TO BE MADE PURSUANT TO SECTION 3.1 SHALL BE DEEMED TO
BE SATISFIED IF DECODE PAYS TO THE INSTITUTION ANNUAL MINIMUM ROYALTIES OF
$________ DURING EACH CALENDAR YEAR PURSUANT TO SECTION 5.1 OR, IF SUCH AMOUNT
HAS NOT BEEN PAID PURSUANT TO SECTION 5.1, THEN IF DECODE PAYS ANY SHORTFALL TO
INSTITUTION WITHIN SIXTY (60) DAYS AFTER THE END OF SUCH CALENDAR YEAR.]
3.3 Commercialization by Certain Sublicensees. deCODE shall be deemed
to have complied with all requirements of Section 3.2 if deCODE grants a
sublicense to a Sublicensee who is pharmaceutical company with a market
capitalization/net assets in excess of [CONFIDENTIAL TREATMENT REQUESTED] and
who has agreed in writing to use reasonable commercial efforts to develop,
market and sell Products in the License Field or meets such other criteria as
the Parties agree are acceptable.
3.4 Progress Reports. At intervals no longer than once every twelve
(12) months, deCODE shall provide a written summary report to Institution on
progress made toward the foregoing objectives.
4. Filing, Prosecution and Maintenance of Patent Rights.
4.1 Duties and Costs. Subject to Section 4.3 and 4.4, Institution shall
be responsible for the preparation, filing, prosecution and maintenance of all
patent applications and patents included in Patent Rights. deCODE shall
reimburse Institution for all reasonable costs ("Costs") incurred by Institution
for the preparation, filing, prosecution and maintenance of all Patent Rights as
follows:
4.1.1 Subject to Sections 4.3 and 4.6, for all Costs incurred
by Institution from and after the Effective Date, deCODE shall reimburse
Institution upon receipt of invoices from Institution; and
4.1.2 For all Costs incurred by Institution prior to the
Effective Date, which have not been previously reimbursed by deCODE, deCODE
shall reimburse Institution within ten (10) days after receipt of invoices
therefor following execution of this Agreement.
4.2 deCODE's Interests. With respect to any Patent Right, each document
or a draft thereof pertaining to the filing, prosecution, or maintenance of such
Patent Right pursuant to Section 4.1, including but not limited to each patent
application, office action, response to office action, request for terminal
disclaimer, and request for reissue or reexamination of any patent issuing from
such application shall be provided to deCODE as follows. Documents received from
any patent office or counsel's analysis thereof shall be provided promptly after
receipt. For a document to be filed in any patent office, a draft of such
document shall be provided sufficiently prior to its filing, to allow for review
and comment by the deCODE. With respect to any proposed filings to be made to
any patent office for the Patent Rights, Institution shall consult with deCODE,
shall in good faith consider and give due respect to deCODE's position, and
shall
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where practicable and not contrary to state or federal regulations or
Institution's policies, act in deCODE's best interests with respect thereto.
4.3 Abandonment by deCODE. If at any time during any such preparation,
filing, prosecution or maintenance action, deCODE shall elect not to pay or
continue to pay the Costs for such Patent Right, deCODE shall so notify
Institution in writing of its election and deCODE shall thereafter be relieved
of the obligation to pay any additional Costs regarding such Patent Right
incurred after the receipt of such notice by Institution. Such U.S. or foreign
patent application or patent shall thereupon cease to be a Patent Right
hereunder and Institution shall be free to license its rights to that particular
U.S. or foreign patent application or patent to any other person on any terms.
4.4 Abandonment by Institution. In the event that Institution does not
wish to prepare, file, prosecute or maintain, as the case may be, any Patent
Rights, it shall first without delay notify deCODE, and deCODE, at its own
expense, and shall be free, where not contrary to United States law, to prepare,
file, prosecute or maintain, as the case may be, such patent applications or
patents. Institution shall render deCODE, at deCODE's expense, all reasonable
assistance in order to facilitate such action. Any such patent application or
patent shall be considered a Patent Right for all purposes of this Agreement.
4.5 Joint Patent Rights. deCODE, at its sole expense, shall be
responsible for the preparation, filing, prosecution and maintenance of all
patent applications and patents jointly owned by deCODE and Institution ("Joint
Patent Rights") included in Patent Rights. Institution shall render deCODE, at
deCODE's expense, all reasonable assistance in order to facilitate such action.
Any such Joint Patent Right shall be considered a Patent Right for all purposes
of this Agreement, provided that for any such Joint Patent Right, each document
or a draft thereof pertaining to the filing, prosecution, or maintenance of such
Joint Patent Right pursuant to this Section 4.5, including but not limited to
each patent application, office action, response to office action, request for
terminal disclaimer, and request for reissue or reexamination of any patent
issuing from such application shall be provided to Institution as follows.
Documents received from any patent office or counsel's analysis thereof shall be
provided promptly after receipt. A draft of any document to be filed with any
patent office shall be provided sufficiently prior to its filing to allow for
review and comment by Institution, if reasonably practicable. Notwithstanding,
with respect to any proposed filings to be made to any patent office for the
Patent Rights, deCODE shall consult with Institution and shall in good faith
consider and give due respect to Institution's position. In the event that such
Joint Patent Right claims a "subject invention" as defined by 35 U.S.C. Section
201, deCODE shall comply with 35 U.S.C. SectionSection 200 et seq. and the
applicable regulations in the filing, prosecution, maintenance and sublicensing
of such Joint Patent Right.
4.6 deCODE's Abandonment of Joint Patent Rights. In the event that
deCODE does not wish to prepare, file, prosecute or maintain, as the case may
be, any of the Joint Patent Rights, it shall first without delay notify
Institution, and Institution, at its own expense, shall be free, where not
contrary to United States law to prepare, file, prosecute or maintain, as the
case may be, such Joint Patent Right. deCODE shall render Institution, at
Institution's expense, all
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reasonable assistance in order to facilitate such action. Any such Joint Patent
Right shall thereupon cease to be a Patent Right hereunder and Institution shall
be free to license its rights to that particular joint patent application or
joint patent to any Third Party on any terms.
5. Royalties and Milestone Payments.
5.1 Royalties. deCODE shall pay Institution royalties in accordance
with the following schedule, such undertaking and schedule having been agreed to
for the purpose of reflecting and advancing the mutual convenience of the
Parties, beginning with the First Commercial Sale in any country.
5.1.1 On all sales of a Product by deCODE, ____ percent ( %)
of the Net Sales Price so long as the manufacture, use importation or sale of
such Product is covered by a Valid Claim of any Patent Rights licensed
exclusively to deCODE.
5.1.2 There shall be no royalties due by deCODE to Institution
on any sales of a Product which is not covered by a Valid Claim of any Patent
Right.
5.2 Royalty Obligation. Only one royalty under Section 5.1 shall be due
and payable to Institution by deCODE for any Product regardless of the number of
Patent Rights or amount of Technological Information covering such Product.
5.3 Sublicense Royalties. deCODE shall pay Institution ______ percent
(__%) of all Sublicensing Income received by deCODE from its Sublicensees with
respect to the sale of Products by such Sublicensee. "Sublicensing Income" shall
mean all monetary consideration or consideration paid in equity, including, for
example, up-front payments, milestones, royalties, and stock or other forms of
equity received by deCODE from its Sublicensees with respect to the Products,
but excluding any amounts received by deCODE in consideration for (a) equity,
(b) debt, (c) research and development expenses, (d) amounts received for the
license or sublicense of (i) any intellectual property other than the Patent
Rights, or (ii) any products other than the Products, (e) rights or benefits
unrelated to the Products or related to other services being provided by deCODE
to such Sublicensee, or (f) reimbursement for patent or other expenses. In the
event that a sublicense of Products is being granted by deCODE together with
other products, deCODE shall make a good faith allocation of the amount of
consideration being made with respect to Products.
5.4 Milestone Payments. In addition to the payments provided for in
Sections 5.1, 5.2 and 5.3, deCODE shall pay Institution the following amounts
upon the occurrence of the following events:
5.4.1 $_____________ upon execution of this Agreement;
5.4.2 $_____________ upon [CONFIDENTIAL TREATMENT REQUESTED];
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5.4.3 $_____________ upon [CONFIDENTIAL TREATMENT REQUESTED].
5.5 Royalties of Combined Products. Where a Product is sold in
combination with one or more other products that are not Products (the "Combined
Product"), deCODE shall pay royalties to Institution based upon the value of the
Combined Product attributable to the Patent Rights. The Parties agree to
negotiate in good faith to reach a mutual agreement concerning the value of
Combined Product attributable to such Patent Rights or Technological
Information.
5.6 Third Party Royalties. In the event that deCODE is required to pay
royalties to one or more Third Parties for the license of technology other than
the Patent Rights or the Technological Information in order to make, use or sell
a Product, then deCODE shall be entitled to reduce its royalty obligation, on a
country by country basis, pursuant to Sections 5.1 and 5.5 by [CONFIDENTIAL
TREATMENT REQUESTED] of the aggregate amount due to such Third Parties, but in
no event shall such reduction exceed [CONFIDENTIAL TREATMENT REQUESTED] of the
royalties otherwise due to Institution under this Agreement.
5.7 Royalty Reduction. In the event that the royalty paid to
Institution is a significant factor in the return realized by deCODE so as to
diminish deCODE's capability to respond to competitive pressures in the market,
Institution agrees to consider a reasonable reduction in the royalty paid to
Institution as to each such Product for the period during which such market
condition exists. Factors determining the size of the reduction will include
profit margin on such Product and on analogous products, prices of competitive
products, total prior sales by deCODE, and deCODE's expenditures in Product
development.
5.8 Past Due Payments. The payments due under this Agreement shall, if
past due, bear interest until payment is made at a per annum rate equal to
[CONFIDENTIAL TREATMENT REQUESTED] above the prime rate in effect at the Bank of
Boston on the due date, not to exceed the maximum permitted by law. The payment
of such interest shall not preclude Institution from exercising any other rights
it may have as a consequence of the lateness of any payment.
6. Reports and Payments.
6.1 Record Keeping. deCODE shall keep, and shall cause each of its
Sublicensees, if any, to keep full and accurate books of accounts in sufficient
detail to allow Institution or its designee to confirm the accuracy of amounts
payable to Institution under this Agreement. Such books of account shall be kept
at deCODE's or such Sublicensee's principal place of business, as the case may
be. The keeper of such books of account shall maintain books covering each
Accounting Period for the three (3) years following the end of such Accounting
Period and shall permit Institution or its designee, at Institution's expense,
to inspect such books of accounts during reasonable business hours for the
purpose of verifying royalty statements or compliance with this Agreement.
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6.2 Payment Form and Date. In each year the amount of royalty due shall
be calculated semiannually as of the end of each Accounting Period and shall be
paid semiannually within the sixty (60) days next following such date, every
such payment to be made in United States currency and to be supported by the
accounting method prescribed in Section 6.3, or in the case of deCODE's
Sublicensee, according to such other reasonable accounting method used by such
Sublicensee. Whenever conversion from any foreign currency shall be required,
such conversion shall be at the rate of exchange thereafter published in The
Wall Street Journal for the last business day of the applicable Accounting
Period.
6.3 Payment Reports. With each semiannual payment, deCODE shall deliver
to Institution a full and accurate accounting to include at least the following
information:
6.3.1 Quantity of each Product sold or leased (by country) by
deCODE, and its Sublicensees;
6.3.2 Total xxxxxxxx for each Product (by country);
6.3.3 Quantities of each Product used by deCODE and its
Sublicensees;
6.3.4 Names and addresses of all Sublicensees of deCODE; and
6.3.5 Total royalties payable to Institution.
7. Infringement.
7.1 Right of Institution. If either Party learns of an infringement or
other use, rights or ownership claim or threatened infringement or other such
claim by a Third Party with respect to any Patent Rights, such Party shall
promptly notify the other Party and shall provide such other Party with
available evidence of such infringement, whereupon Institution shall have the
first right, but not the duty, to institute at its sole cost and expense,
actions against Third Parties based on any Patent Rights under this Agreement.
7.2 Right of deCODE. In the event that Institution does not institute
an infringement proceeding against an offending Third Party within ninety (90)
days after obtaining knowledge of such alleged infringement or misappropriation,
deCODE shall have the right, but not the duty, to institute at its sole cost and
expense, an action to enforce such Patent Rights with respect to any
infringement or misappropriation by a Third Party.
7.3 Cooperation and Expenses. In the event one Party shall initiate or
carry on legal proceedings to enforce any Patent Rights against any alleged
infringer, the other Party shall fully cooperate with and supply all assistance
reasonably requested by the Party initiating or carrying on such proceedings.
The Party which institutes any suit to protect or enforce a Patent Right shall
have sole control of that suit and shall bear the reasonable expenses (excluding
legal fees) incurred by said other Party in providing such assistance and
cooperation as is requested pursuant
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to this Section. If the Parties elect to cooperate in instituting and
maintaining such action, such costs and expenses shall be borne by the Parties
in such proportions as they may agree in writing.
7.4 Execution of Documents and Other Acts. Each Party shall execute all
necessary and proper documents, take such actions as shall be appropriate to
allow the other Party to institute and prosecute such infringement actions and
shall otherwise cooperate in the institution and prosecution of such actions
(including, without limitation, consenting to being named as a nominal party
thereto).
7.5 Enforcement Award. Any award paid by Third Parties as a result of
such an infringement action (whether by way of settlement or otherwise) shall be
applied first to reimburse both Parties for all costs and expenses incurred by
the Parties with respect to such action on a pro rata basis and, if after such
reimbursement any funds shall remain from such award, they shall be allocated as
follows:
7.5.1 [CONFIDENTIAL TREATMENT REQUESTED];
7.5.2 [CONFIDENTIAL TREATMENT REQUESTED] ; or
7.5.3 If the Parties have cooperated in instituting and maintaining
such action, the Parties shall allocate such remaining funds between themselves
in the same proportion as they have agreed to bear the expenses of instituting
and maintaining such action.
7.6 Infringement Actions by Third Parties. In the event of the
institution of any suit by a Third Party against deCODE for patent infringement
which dominates the Patent Rights and involves the manufacture, sale,
distribution or marketing of any Product, and such suit is not covered by the
indemnification provided pursuant to Section 8.1.2, deCODE shall have the right
to defend such suit at its own expense, and Institution hereby agrees to assist
and cooperate with deCODE, at deCODE's expense, to the extent necessary in the
defense of such suit. During the pendency of any such action, deCODE shall
continue to make all payments due under this Agreement; provided, however, that
deCODE shall be entitled to a credit against such payments of an amount equal to
one-half of the reasonable costs actually incurred in such action.
7.7 Infringement Award in deCODE's Favor in Actions by Third Parties.
If deCODE finally prevails and receives an award from such Third Party as a
result of such action (whether by way of judgment, award, decree, settlement or
otherwise), such award shall be allocated, first, to deCODE and Institution to
reimburse each Party for its pro rata share of costs and expenses incurred in
such action, and the remaining amount shall be [CONFIDENTIAL TREATMENT
REQUESTED].
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7.8 Infringement Award Against deCODE in Actions by Third Parties. If
deCODE finally loses, whether by judgment, award, decree, settlement or
otherwise), and is required to pay a royalty or damages to such Third Party in
order to make, use, have made or import a Product, deCODE shall continue to pay
the royalties for such Product in the countries which are
the subject of such action, but shall be entitled to a credit against such
payments in an amount equal to the royalty or damages paid to such Third Party
under the terms set forth in Section 5.6.
7.9 Right to Terminate Agreement. If deCODE is required to pay a
royalty or damages to a Third Party pursuant to Section 7.8 and the amount of
such royalty or damages exceeds [CONFIDENTIAL TREATMENT REQUESTED] of the
royalties due hereunder for such Product in such country(ies), deCODE shall have
the right to terminate this Agreement solely with respect to such Product in
such country(ies).
8. Indemnification and Insurance.
8.1 Indemnification.
8.1.1 deCODE shall indemnify, defend and hold harmless
Institution and its trustees, officers, medical and professional staff,
employees, and agents and their respective successors, heirs and assigns (the
"Institution Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorney's fees and expenses of litigation) incurred by or
imposed upon the Institution Indemnitees or any one of them in connection with
any claims, suits, actions, demands or judgments of a Third Party to the extent
arising out of any theory of product liability (including, but not limited to,
actions in the form of tort, warranty, or strict liability) concerning any
product, process or service made, used or sold pursuant to any right or license
granted under this Agreement; and shall, at deCODE's own expense provide
attorneys reasonably acceptable to Institution to defend against any actions
brought or filed against such Institution Indemnitee whether or not such actions
are rightfully brought. deCODE's indemnification under this Section 8.1.1 shall
not apply to any liability, damage, loss or expense to the extent that it is
directly attributable to the negligent activities, reckless misconduct or
intentional misconduct of the Institution Indemnitees.
8.1.2 Institution shall indemnify, defend and hold harmless
deCODE and its directors, officers, professional staff, employees, and agents
and their respective successors, heirs and assigns (the "deCODE Indemnitees"),
against any liability, damage, loss or expense (including reasonable attorney's
fees and expenses of litigation) incurred by or imposed upon the deCODE
Indemnitees or any one of them in connection with any claims, suits, actions,
demands or judgments of a Third Party to the extent arising out of any breach of
the Institution's representations and warranties set forth in Section 10; and
shall, at Institution's own expense provide attorneys reasonably acceptable to
deCODE to defend against any actions brought or filed against such deCODE
Indemnitee whether or not such actions are rightfully brought.
8.1.3 In the event that any Institution Indemnitee or deCODE
Indemnitee (an "Indemnitee") entitled to indemnification under Section 8.1.1 or
8.1.2 is seeking such indemnification, such Indemnitee shall inform the
indemnifying Party of the claim as soon as
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reasonably practicable after such Indemnitee receives notice of such claim,
shall permit the indemnifying Party to assume direction and control of the
defense of the claim (including the sole right to settle it at the sole
discretion of the indemnifying Party, provided that such settlement does not
impose any obligation on, or otherwise adversely affect, the Indemnitee or the
other Party) and shall cooperate as requested (at the expense of the
indemnifying Party) in the defense of the claim. As the Parties intend complete
indemnification, all costs and expenses incurred by an Indemnitee in connection
with enforcement of Section 8.1.1 or 8.1.2 shall also be reimbursed by the
indemnifying Party.
8.1.4 This Section 8.1 shall survive expiration or termination
of this Agreement.
8.2 Insurance.
8.2.1 Beginning at such time as any Product is being
commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by deCODE or by a Sublicensee agent of deCODE, deCODE
shall, at its sole cost and expense, procure and maintain commercial liability
insurance in amounts not less than [CONFIDENTIAL TREATMENT REQUESTED] per
incident and [CONFIDENTIAL TREATMENT REQUESTED] annual aggregate and naming the
Institution Indemnitees as additional insureds. Such commercial liability
insurance shall provide (i) product liability coverage and (ii) broad form
contractual liability coverage for deCODE's indemnification under Section 8.1 of
this Agreement. If deCODE elects to self-insure all or part of the limits
described above (including deductibles or retentions which are in excess of
[CONFIDENTIAL TREATMENT REQUESTED] annual aggregate) such self-insurance program
must be acceptable to the Institution and the Risk Management Foundation. In the
event deCODE's Sublicensees elect to self-insure all or part of such limits,
such self-insurance program shall be deemed acceptable to the Risk Management
Foundation. The minimum amounts of insurance coverage required under this
Section 8.2.1 shall not be construed to create a limit of deCODE's liability
with respect to its indemnification under Section 8.1 of this Agreement.
8.2.2 deCODE shall provide Institution with written evidence
of such insurance upon request of Institution. deCODE shall provide Institution
with written notice at least fifteen (15) days prior to the cancellation,
non-renewal or material change in such insurance; if deCODE does not obtain
replacement insurance providing comparable coverage prior to the expiration of
such fifteen (15) day period, Institution shall have the right to terminate this
Agreement effective at the end of such fifteen (15) day period without notice or
any additional waiting periods.
8.2.3 deCODE shall maintain such commercial institution
liability insurance beyond the expiration or termination of this Agreement
during: (a) the period that any Product is being commercially distributed or
sold (other than for the purpose of obtaining regulatory approvals) by deCODE or
by a Sublicensee or agent of deCODE; and (b) a reasonable period after the
period referred to in Section 8.2.3(a), which in no event shall be less than
[CONFIDENTIAL TREATMENT REQUESTED].
8.2.4 This Section 8.2 shall survive expiration or termination
of this Agreement.
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8.3 Disclaimer. OTHER THAN THE REPRESENTATIONS AND WARRANTIES SET FORTH
UNDER THIS AGREEMENT, INSTITUTION MAKES NO WARRANTY, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR ANY
IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT,
TRADEMARK, SOFTWARE, TRADE SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR
DATA LICENSED OR OTHERWISE PROVIDED TO deCODE HEREUNDER AND HEREBY DISCLAIMS THE
SAME.
9. Termination.
9.1 Term. This Agreement shall commence as of the Effective Date of
this Agreement and, unless sooner terminated as provided hereunder, shall
terminate as follows:
9.1.1 As to each Product, this Agreement shall terminate upon the
later of: (a) 15 years from the Effective Date of this Agreement; (b) the
expiration of the last to expire of the Patent Rights necessary for the
manufacture, use and sale of such Product in such country; or (c) 5 years after
the First Commercial Sale of such Product in such country.
9.1.2 This Agreement shall terminate in its entirety upon its
termination as to all Products.
9.2 Termination by deCODE. deCODE shall have the right to terminate the
licenses granted herein, in whole or as to any Product in any country, at any
time, and from time to time, by giving notice in writing to Institution. Such
termination shall be effective sixty (60) days from the date such notice is
given, and all deCODE's rights associated therewith shall cease as of that date,
subject to Sections 9.5, 11 and 12.
9.3 Termination by Institution. Institution shall have the right to
terminate the licenses granted herein, as to any Product in any country, upon
written notice to deCODE in the event that after the First Commercial Sale of
such Product in such country there is a continuous one (1) year period in which
no Product is sold in such country, provided such sale is not prevented by force
majeure, government regulation or intervention, or institution of a law suit by
any Third Party. Such termination shall be effective sixty (60) days from the
date such notice is given, and all deCODE's rights associated therewith shall
cease as of that date, subject to Sections 9.5, 11 and 12.
9.4 Default; Notice; Cure. If either party shall fail to faithfully
perform any of its obligations under this Agreement except the due diligence
milestones specified in Section 3 herein, the nondefaulting Party may give
written notice of the default to the defaulting Party. Unless such default is
corrected within sixty (60) days after such notice, the notifying Party may
terminate this Agreement and the license hereunder upon sixty (60) days prior
written notice, provided that only three such sixty (60) day grace periods shall
be available in any twelve (12) month period with respect to a default of any
particular provision hereunder. Thereafter notice of default of said provision
shall constitute termination.
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9.5 Disposal of Inventory. Upon the termination of any license granted
herein, in whole or as to any Product for any reason other than a failure to
cure a material breach of the Agreement by deCODE, deCODE shall have the right
for one year or such longer period as the Parties may reasonably agree to
dispose of all Product or substantially completed then on hand to which such
termination applies, and royalties shall be paid to Institution with respect to
such Product as though this Agreement had not terminated.
9.6 Rights following Expiration or Termination.
9.6.1 Following expiration of this Agreement as to each Product
pursuant to Section 9.1.1, deCODE shall have the royalty-free non-exclusive
right within the License Fields to continue to use such Product as heretofore
licensed.
9.6.2 Following expiration of this Agreement in its entirety
pursuant to Section 9.1.2 or termination by deCODE pursuant to Section 9.4,
deCODE shall have the royalty-free non-exclusive right within the License Fields
to continue to use such Product as heretofore licensed.
9.6.3 Upon termination of this Agreement as to any Product in any
country by Institution pursuant to Section 9.3: (i) deCODE shall promptly
transfer to Institution copies of all data, reports, records and materials in
deCODE's possession or control which relate to such Products; (ii) all licenses
granted for Patent Rights covering such Product in such country by Institution
to deCODE under Section 2 shall terminate; (iii) all sublicenses granted by
deCODE under this Agreement with respect to such Product in such country shall
be subject to Section 9.7, and (iv) ownership of all INDs, NDAs and other
regulatory filings made or filed for such Product in such country shall be
transferred to Institution. Thereafter, Institution shall have the right to
develop, make, have made, use, sell or have sold such Product in such country,
subject to such sublicenses.
9.6.4 Upon termination of this Agreement in its entirety by deCODE
pursuant to Section 9.4, in addition to any other remedies available to deCODE
at law or in equity: (i) Institution shall promptly transfer to deCODE copies of
all data, reports, records and materials in Institution's possession or control
that relate to the Products; (ii) return to deCODE all relevant records and
materials in Institution's possession or control containing Confidential
Information of deCODE; and (iii) ownership of all INDs, NDAs and other
regulatory filings made or filed for any Product shall be transferred solely to
deCODE. The right and license granted to deCODE by Institution pursuant to
Section 2 shall continue in full force and effect without further obligation to
Institution.
9.6.5 Upon termination of this Agreement by Institution pursuant to
Section 9.4, in addition to any other remedies available to Institution at law
or in equity: (i) deCODE shall promptly transfer to Institution copies of all
data, reports, records and materials in deCODE's possession or control; (ii)
return to Institution all relevant records and materials in deCODE's possession
or control containing Confidential Information of Institution; (iii) all
licenses granted
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for Patent Rights by Institution to deCODE under Section 2 shall terminate; (iv)
all sublicenses granted by deCODE under this Agreement shall be subject to
Section 9.7, and (v) ownership of all INDs, NDAs and other regulatory filings
shall be transferred to Institution. Thereafter, Institution shall have the
right to develop, make, have made, use, sell or have sold Products, subject to
such sublicenses.
9.6.6 Upon termination of this Agreement with respect to any
Product in any country by deCODE pursuant to Section 7.9 or 9.2: (i) each Party
shall promptly transfer to the other Party copies of all data, reports, records
and materials of the other Party in the possession or control of such Party
which relate to such Product; and (ii) all licenses granted by either Party to
the other Party under Section 2 shall terminate. Thereafter, each Party shall
have the right to develop, make, have made, use, sell or have sold such Product
in such country, to the extent legally permissible.
9.7 Rights Under Sublicenses Upon Termination. In the event that any
license granted to deCODE under this Agreement is terminated, any sublicense
under such license granted prior to termination of said license shall remain in
full force and effect, provided that:
9.7.1 The Sublicensee is not then in breach of its sublicense
agreement;
9.7.2 The Sublicensee agrees to assume the rights and
obligations of deCODE under the terms and conditions of this Agreement, as
modified by the provisions of this Section 9.7;
9.7.3 The Sublicensee, at Institution's written request,
assumes in a signed writing the same obligations to Institution as those assumed
by deCODE under Sections 8 and 11;
9.7.4 Institution shall have the right to receive the greater
of (a) any payments payable to deCODE under such sublicense agreement to the
extent they are reasonably and equitably attributable to such Sublicensee's
right under such sublicense to use and exploit Patent Rights and/or
Technological Information or (b) the lowest royalty which is within the
"Competitive" range as hereinafter defined, at the time Institution's license to
deCODE is terminated. A royalty rate shall be regarded as "Competitive" if it is
within the range of royalty rates that Institution would charge in an arms
length transaction with a licensee which was not and had not been a sponsor of
research at Institution, taking into account the value of the licensed
technology at the time Institution's license to deCODE is terminated; and
9.7.5 Institution shall not assume, and shall not be
responsible to such Sublicensee for, any representations, warranties or
obligations of deCODE to such Sublicensee, other than to permit such Sublicensee
to exercise any rights to Patent Rights and Technological Information that are
granted under such sublicense agreement consistent with the terms of this
Agreement.
9.8 Payment of Royalties Upon Termination. Upon termination of any
license granted hereunder, deCODE shall pay Institution all royalties due or
accrued on (a) the sale of Products
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up to and including the date of termination, and (b) for twelve (12) months
following the date of termination, the sale of Products manufactured prior to
the termination date.
10. Representations and Warranties.
10.1 Ownership. Institution represents and warrants that: (a) to the
best of its knowledge, Institution is the owner of all right, title and interest
in the Patent Rights and has the right to grant the right and license granted to
deCODE under this Agreement; and (b) Institution has not entered into any
agreement with any Third Party which is in conflict with the rights granted to
deCODE pursuant to this Agreement. Notwithstanding the foregoing, Institution
makes no representation or warranty as to the validity of any Patent Rights
licensed under this Agreement.
10.2 Disclosure. Institution represents and warrants that it has fully
disclosed to deCODE all information in Institution's possession or control
relating to the Patent Rights, including, without limitation, any communications
with any Third Parties relating to any of the foregoing.
10.3 Power to Grant License. Institution represents and warrants that
it is not prohibited by the United States Government or by any other foreign or
domestic governmental authority from granting the right and license in the
Patent Rights and Technological Information to deCODE under this Agreement
10.4 Survival. The representations and warranties contained in this
Section 10 shall survive the termination of this Agreement.
11. Alternative Dispute Resolution.
11.1 Negotiation. The Parties shall attempt in good faith to resolve,
through negotiation any dispute, claim or controversy arising out of or relating
to this Agreement. Either Party may initiate negotiations by providing written
notice in letter form to the other party, setting forth the subject of the
dispute and the relief requested. The recipient of such notice shall respond
within five (5) days with a written statement of its position on, and
recommended solution to, the dispute. If the dispute is not resolved by this
exchange of correspondence, then representatives of each Party with full
settlement authority shall meet at a mutually agreeable time and place within
ten (10) days of the date of the initial notice in order to exchange relevant
information and perspectives, and to attempt to resolve the dispute.
11.2 Arbitration. Except with respect to breaches for which a Party is
seeking injunctive relief, all disputes between the Parties relating to this
Agreement or the subject matter hereof which cannot be resolved by the Parties
according to Section 11.2.1 shall, be submitted for final and binding
arbitration before JAMS/Endispute ("JAMS") pursuant to the United States
Arbitration Act, 9 U.S.C. Sec. 1 et seq., and shall be held at a mutually
agreeable location or in New York City. Any Party may commence the arbitration
process pursuant to this Agreement by filing a written demand for arbitration
with JAMS, with a copy to the other Party. Unless the
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Parties otherwise agree in writing: the arbitration shall be conducted in
accordance with the provisions of JAMS Comprehensive Arbitration Rules and
Procedures in effect at the time of filing of the demand for arbitration if the
amount in controversy is greater than $250,000, exclusive of interest; or the
arbitration shall be conducted in accordance with the provisions of JAMS
Streamlined Arbitration Rules and Procedures in effect at the time of filing of
the demand for arbitration if the amount in controversy is $250,000 or less,
exclusive of interest. The Parties will cooperate with JAMS and with one another
in selecting an arbitrator from JAMS' panel of neutrals, and in scheduling the
arbitration proceedings; provided, however, that all arbitrators must be
knowledgeable in the pharmaceutical industry or bioinformatics or other
technology areas as appropriate to the Patent Rights licensed hereunder, and
must not be affiliated through employment or otherwise with a competitor of
either Party, as determined through mutual assent of the Parties. The Parties
shall participate in the arbitration in good faith, and shall share equally in
its costs. The provisions of this Section may be enforced by any Court of
competent jurisdiction, and the Party seeking enforcement shall be entitled to
an award of all costs, fees and expenses, including attorneys fees, to be paid
by the party against whom enforcement is ordered.
11.3 Injunction. This Section 11 shall not prohibit a Party from
seeking injunctive relief from a court of competent jurisdiction in the event of
a breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
12. Miscellaneous.
12.1 Governing Law. This Agreement will be governed by, construed, and
interpreted in accordance with the laws of the State of Delaware, without
reference to principles of conflicts of laws.
12.2 Assignment. Neither Party shall assign its rights or duties under
this Agreement to another without the prior express written consent of the other
Party, which consent shall not be unreasonably withheld; provided, however, that
either Party may assign this Agreement to a successor in ownership of all or
substantially all its business assets. Such successor shall expressly assume in
writing the obligation to perform in accordance with the terms and conditions of
this Agreement.
12.3 Notices. All notices, demands and other communications of every
kind and description whatsoever required or permitted under this Agreement shall
be in writing and shall be deemed to have been received when personally
delivered, or when shipped by private express carrier (signature required),
shipment charges prepaid, or when sent via facsimile transmission (receipt
verified) to the Party to whom delivery shall be made at the respective
addresses as set out below.
If to Institution, to:
Institution:
_________________________________________
Attn:
_________________________________________________
Licensing
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____________________________________________
Institution Agreement #
______________________________
Telephone:
___________________________________________
Facsimile:
If to deCODE, to:
____________________________________
deCODE genetics Ltd.
Xxxxxxxxx 0
XX-000 Xxxxxxxxx, Xxxxxxx
Attn:
________________________________________________
Telephone: x000-000-0000
Facsimile: x000-000-0000
12.4 Modification. No modification or waiver of this Agreement or of
any covenant, condition, or limitation herein contained shall be valid unless in
writing and duly executed by both Parties.
12.5 Waiver. No waiver of any rights will be effective unless assented
to in writing by the Party to be charged and the waiver of any breach or default
will not constitute a waiver of any other right hereunder or any subsequent
breach or default.
12.6 Headings. The Section headings are intended for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
12.7 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement will continue in full force and effect
without said provision; provided that no such severability will be effective if
the result of such action materially changes the economic benefit of this
Agreement to deCODE or to Institution.
12.8 Construction. The Parties have participated equally in the
creation of this Agreement; the language of this Agreement will not be
presumptively construed against either party.
12.9. Survival. Sections 1, 6, 7, 8, 9.5, 9.6, 9.7, 9.8, 10, 11, 12.1,
12.7, 12.8 and 12.9 shall survive any expiration or termination of this
Agreement.
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12.10 Counterparts. This Agreement may be executed in counterparts,
each of which will be deemed an original, but all of which together will
constitute one agreement.
* * *
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In witness whereof, the Parties have caused this Agreement to be
executed by their duly authorized representatives as of the date first set forth
above.
INSTITUTION: DECODE GENETICS LTD.:
BY:__________________________ BY:___________________________
NAME:__________________________ NAME:____________________________
TITLE:__________________________ TITLE:____________________________
DATE:__________________________ DATE:____________________________
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[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIALITY HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.]
CROSSWALK DEVELOPMENT AGREEMENT
BETWEEN
PARTNERS HEALTHCARE SYSTEM, INC.,
The General Hospital Corporation,
d.b.a. Massachusetts General Hospital,
The Xxxxxxx and Women's Hospital, Inc.
And
deCODE genetics Ltd.
DATED MAY 11, 2000
150
CROSSWALK DEVELOPMENT AGREEMENT
THIS CROSSWALK DEVELOPMENT AGREEMENT (this "Agreement"), effective May
11, 2000, ("Effective Date"), is by and among Partners HealthCare System, Inc.,
a Massachusetts not-for-profit corporation with its principal place of business
at Prudential Tower, 000 Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx, 00000-0000
("Partners"); The General Hospital Corporation d.b.a. Massachusetts General
Hospital, a Massachusetts not-for-profit corporation having its principal
offices at 00 Xxxxx Xxxxxx, Xxxxxx, XX 00000 ("MGH"); The Xxxxxxx and Women's
Hospital, Inc., a Massachusetts not-for-profit corporation having its principal
offices at 00 Xxxxxxx Xxxxxx, Xxxxxx, XX 00000 ("BWH") (BWH, Partners and MGH
are each, individually, an "Institution" and, collectively, the "Institutions");
and deCODE genetics Ltd., an Icelandic corporation which is a wholly-owned
subsidiary of deCODE genetics, Inc., a Delaware corporation, and having its
principal offices at Xxxxxxxxx 0, XX-000 Xxxxxxxxx, Xxxxxxx ("deCODE").
Partners, MGH, BWH and deCODE are each, individually, a "Party" and,
collectively, the "Parties".
BACKGROUND
A. deCODE is building a database based on phenotypic healthcare
information that deCODE is collecting using the homogeneous Icelandic population
(the "Icelandic Healthcare Database" or "IHD") and a database based on genotypic
information that deCODE intends to collect (the "deCODE Genotype Database" and
collectively with the IHD, the "deCODE Database"). Partners is creating a
database based on the phenotypic and genotypic information that Partners is
collecting in connection with internal research using various heterogeneous
populations ("Research Patient Data Registry" or "RPDR") (the deCODE Database
and the RPDR are individually referred to as a "Database" and collectively
referred to as the "Databases").
B. The Parties desire to develop an information technology bridge
(the "Crosswalk") to facilitate studies with the Databases. The Crosswalk is to
be developed by a number of means, including the creation of common definitions
of disease classifications, common structure and field compatibility of
databases, and the creation of tools to query both Databases. Standard operating
procedures for querying the databases via the Crosswalk while preserving
patients' confidential information are to be established under the Strategic
Alliance Agreement entered into by deCODE and Partners simultaneously with this
Agreement (the "Strategic Alliance Agreement").
C. Institutions desire to obtain funding and technical support
from deCODE to further such development. deCODE wishes to obtain from
Institutions certain rights to Crosswalk Intellectual Property Rights, pursuant
to the terms and conditions of this Agreement and the Strategic Alliance
Agreement.
The Parties have, therefore, agreed as follows:
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1. Definitions.
1.1 "BWH" shall have the meaning assigned to such term in the
Introductory paragraph.
1.2 "Confidential Information" of a Party shall mean (a) all
Crosswalk Inventions which the IP Project Leaders decide to protect as
Confidential Information pursuant to Section 4.2, technical or marketing
reports, data or information disclosed by such Party to the other Party which is
in writing and marked or otherwise designated in writing as "Confidential" or
"Proprietary," (b) any item described in Section 1.2(a) which is disclosed
orally, indicated as confidential at the time of disclosure, summarized in
writing and marked or otherwise designated in writing as "Confidential" or
"Proprietary" within thirty (30) days after such disclosure, (c) any source code
or object code for software comprising any part of the Crosswalk, and (d) other
source code or object code disclosed by one Party to the other which is marked
or otherwise designated in writing as "Confidential" or "Proprietary" at the
time of disclosure.
1.3 "Copyright" shall mean the copyright subsisting in accordance
with the United States Copyright Law, foreign copyright laws and international
agreements in the Crosswalk Copyrightable Work (as that term is defined below)
together with any United States or foreign Copyright registration application or
resulting Copyright registration.
1.4 "Crosswalk" shall mean the information technology bridge (a)
created by deCODE Personnel and/or Institution Personnel in the performance of
the Crosswalk Project and (b) Embedded Technology. Unless otherwise expressly
provided herein, the term "Crosswalk" shall not include Other Technology.
1.5 "Crosswalk Coordinator" shall mean the deCODE Personnel or the
Institution Personnel appointed to this position in accordance with Section 2.2.
1.6 "Crosswalk Copyrightable Work" shall mean any original work of
authorship fixed in any tangible medium of expression, now known or later
developed, from which it can be perceived, reproduced, or otherwise
communicated, either directly or with the aid of a machine or device, including
without limitation, computer programs and related documentation, which is
authored by any Party solely or jointly with any other Party, including a
Party's Personnel, in the development of the Crosswalk, or prepared by any
Party's Personnel in the development of the Crosswalk as a Work-Made-For-Hire
(as that capitalized term is defined in the United States Copyright Law), for
which such Party is considered the author and owner solely or jointly with any
other Party or such Party's Personnel.
1.7 "Crosswalk Development Period" shall mean the period during
which the Parties shall create the Crosswalk pursuant to the Work Plan,
beginning on the Effective Date and ending (a) three (3) year(s) from the
Effective Date, and any extension thereof mutually agreed upon by the Parties in
writing, or (b) on the date this Agreement is terminated pursuant to Section 8,
whichever shall occur first.
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1.8 "Crosswalk Information" shall mean the deCODE Crosswalk
Information and/or the Institution Crosswalk Information.
1.9 "Crosswalk Intellectual Property Rights" shall mean the
statutory rights and protection afforded Crosswalk Patent Rights, Crosswalk
Copyrightable Works and/or Confidential Information by the patent, copyright and
trade secret laws of the country where such right is sought, it being understood
that any individual category of intellectual property may be afforded more than
one such statutory right.
1.10 "Crosswalk Invention" shall mean any new and useful process,
formulae, compilations, source code, object code, devices, methods, techniques,
machine, manufacture or composition of matter created or developed in the
performance of the Crosswalk Project, that is potentially patentable or
protectable as Confidential Information and is (a) conceived, solely or jointly,
by one or more deCODE Personnel and/or Institution Personnel in the performance
of the Crosswalk Project, and (b) first reduced to practice by one or more
deCODE Personnel and/or Institution Personnel in the performance of the
Crosswalk Project or in the subsequent one year period by one or more
individuals who, during the Crosswalk Development Period, were deCODE Personnel
or Institution Personnel.
1.11 "Crosswalk Patent Right" shall mean any United States patent
application, including any division or continuation and any foreign patent
application or equivalent corresponding thereto and any Letters Patent or the
equivalent thereof issuing thereon or reissue or extension thereof, which
contains one or more claims to a Crosswalk Invention. Patent Rights shall also
include those claims of any continuation-in-part of the aforementioned patent
applications to the extent they claim a Crosswalk Invention.
1.12 "Crosswalk Project" shall mean the Crosswalk development
project described in the Work Plan attached as Appendix A.
1.13 "CSRL" shall mean for: (a) Partners, the Vice President,
Corporate Sponsored Research and Licensing; (b) BWH, Corporate Sponsored
Research and Licensing at BWH; and (c) MGH, Corporate Sponsored Research and
Licensing at MGH, or any successors thereto.
1.14 "Databases" shall have the meaning assigned to such term in
the Background section.
1.15 "deCODE" shall have the meaning assigned to such term in the
Introductory paragraph.
1.16 "deCODE Crosswalk Information" shall mean any research data,
formulae, process information or other information pertaining to the Crosswalk
produced by deCODE Personnel in the performance of, or relating to, the
Crosswalk Project, including without limitation any research data, formulae,
process information or other information provided by deCODE to Institution or
their agents for the purpose of performing or in the performance of the
Crosswalk Project. Notwithstanding the foregoing, the term "deCODE Crosswalk
Information"
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shall not include patient identifiers or other patient confidential information,
or the data in the deCODE Database.
1.17 "deCODE Database" shall have the meaning assigned to such term
in the Background section.
1.18 "deCODE Genotype Database" shall have the meaning assigned to
such term in the Background section.
1.19 "deCODE Notice" shall have the meaning assigned to such term
in the Strategic Alliance Agreement.
1.20 "deCODE Personnel" shall mean the deCODE employees and
consultants who perform the Crosswalk Project.
1.21 "Effective Date" shall have the meaning assigned to such term
in the Introductory paragraph.
1.22 "Embedded Technology" shall mean any technology owned or
acquired by any Party outside of the performance of the Crosswalk Project and
incorporated or "embedded" into the Crosswalk after the Effective Date to
facilitate studies with the Databases, including any design, technical
description and any software (including programs, modules, code, algorithms,
flowcharts, diagrams, documentation and the like), as expressly described in
Appendix D attached hereto and as amended from time to time pursuant to Section
4.6. Unless otherwise provided in Appendix D, the term "Embedded Technology"
shall not include Other Technology.
1.23 "Icelandic Healthcare Database" or "IHD" shall have the
meaning assigned to such term in the Background section.
1.24 "Institution" and "Institutions" shall have the meanings
assigned to such terms in the Introductory paragraph.
1.25 "Institution Crosswalk Information" shall mean any research
data, formulae, process information or other information pertaining to the
Crosswalk produced by Institution Personnel in the performance of the Crosswalk
Project, but does not include patient identifiers or other patient confidential
information, or the data in the RPDR.
1.26 "Institution Notice" shall have the meaning assigned to such
term in the Strategic Alliance Agreement.
1.27 "Institution Personnel" shall mean the Institutions'
professional staff, graduate student, undergraduate student, employees and
consultants who perform the Crosswalk Project.
1.28 "IP Costs" shall have the meaning assigned to such term in
Section 4.3.
1.29 "IP Project Leader" shall have the meaning assigned to such
term in Section 2.3.
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1.30 "JAMS" shall have the meaning assigned to such term in Section
9.2.
1.31 "Joint Crosswalk Patent Right" shall have the meaning assigned
to such term in Section 4.1.2.
1.32 "Joint Steering Committee" or "JSC" shall have the meaning
assigned to such term in Strategic Alliance Agreement.
1.33 "MGH" shall have the meaning assigned to such term in the
Introductory paragraph.
1.34 "Other Technology" shall mean the design, technical
description and software (including programs, modules, code, algorithms,
flowcharts, diagrams, documentation and the like) developed by a Party outside
the scope of the Crosswalk Project, whether before or during the Crosswalk
Development Period, which is used to facilitate studies from a Party's Database
(e.g., genotypic or phenotypic database infrastructure, a query tool), and which
a Party licenses to the other Party pursuant to a Software License Agreement.
1.35 "Partners" shall have the meaning assigned to such term in the
Introductory paragraph.
1.36 "Party" and "Parties" shall have the meanings assigned to such
terms in the Introductory paragraph.
1.37 "Research Patient Data Registry" or "RPDR" shall have the
meaning assigned to such term in the Background section.
1.38 "Software License Agreement" shall have the meaning assigned
to such term in the Strategic Alliance Agreement.
1.39 "Sponsored Research Agreement" shall have the meaning assigned
to such term in the Strategic Alliance Agreement.
1.40 "Strategic Alliance Agreement" shall have the meaning assigned
to such term in the Background section.
1.41 "Third Party Project" shall have the meaning assigned to such
term in Section 2.5.2.
1.42 "Work Plan" shall have the meaning assigned to such term in
Section 2.1.
2. Work Plan.
2.1 Work Plan. Within sixty (60) days after the Effective Date,
the Crosswalk Coordinators for each of deCODE and the Institutions shall propose
and submit to the JSC
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a proposed work plan and budget for the development of the Crosswalk. Upon
approval of a work plan and budget by the JSC, such approved work plan shall be
attached hereto as Appendix A and made a part hereof (the "Work Plan") and such
budget shall be attached hereto as Appendix B and made a part hereof (the
"Budget").
2.2 Project Coordinators. Each of deCODE and the Institutions
shall appoint a Crosswalk Project coordinator (the "Crosswalk Coordinator") who
shall have day-to-day responsibility for overseeing and coordinating the
activities contemplated herein, including scheduling as set forth in the Work
Plan and presiding over meetings, design/review sessions, coordinating its staff
and conducting testing of the Crosswalk.
2.3 IP Project Leader. Each of deCODE and the Institutions shall
appoint an IP Project Leader, who shall have the duties described in Section 4
of the Strategic Alliance Agreement.
2.4 Performance of Crosswalk Project. The Institutions and deCODE
shall cooperate to create the Crosswalk according to the Work Plan and the
Budget.
2.5 Exclusivity.
2.5.1 At any time during the term of this Agreement,
Institution Personnel or deCODE Personnel may propose in writing additional
development directly related to the Crosswalk Project not previously described
in the Work Plan for the Crosswalk Project as set forth in Appendix A. Each such
proposal shall include a description of the additional development proposed, a
budget of the costs to be funded by deCODE and a schedule of payment of such
costs. Unless the Parties shall otherwise agree in writing, negotiations between
them over any such proposal shall not extend beyond the sixtieth (60th) day next
following the date when the proposal shall have first been so made, and whenever
such negotiations shall end without agreement between the Parties to proceed
with the proposed development, the Party proposing the additional development
may proceed without the other Party and seek funding from any other sponsor,
including but not limited to a commercial sponsor, as set forth in Section
2.5.2, subject to the restrictions provided in this Section 2.5. When such
proposal is accepted by the Institutions and deCODE, it shall be appended hereto
as an addendum to the Work Plan and shall be subject to the terms and conditions
of this Agreement unless otherwise specified, and the additional Crosswalk
Project described therein shall commence and budgeted amounts shall be paid as
set forth in the proposal or as otherwise agreed by the Parties in writing. In
no event shall any additional development be added to the Crosswalk Project nor
shall the direction of the Crosswalk Project be altered without the concurrence
of the Director of CSRL of the Institutions.
2.5.2 Notwithstanding any contrary provision, no member of
the Institution Personnel who shall perform any part of the Crosswalk Project
shall seek funding from another commercial sponsor for any additional
development proposals directly related to the Crosswalk Project unless and until
such proposal has been submitted to deCODE in accordance with the foregoing
Section 2.5.1 and the Parties have failed to agree in writing to append such
proposal hereto as an addendum to the Work Plan within the stipulated sixty (60)
days. In the event of such failure to agree, an Institution Personnel shall be
free to seek and accept funding from such
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commercial sponsor for such development proposal (the "Third Party Project"),
provided that, in the reasonable determination of the JSC created pursuant to
the Strategic Alliance Agreement, after consultation with the Institution
Personnel: (a) the subject matter of the Third Party Project is not so closely
related scientifically to the Crosswalk Project that sponsorship of such Third
Party Project by such other commercial sponsor would create a conflict of
interest for the Institutions or any Institution Personnel performing the
Crosswalk Project; (b) the risk of subject matter overlaps between the Crosswalk
Project and such Third Party Project is minimal; (c) the Third Party Project
would not conflict with the terms and conditions of this Agreement and would not
have a material impact on the Crosswalk Project or the Institutions' ability to
perform the Crosswalk Project; and (d) such other commercial sponsor of the
Third Party Project is not a competitor of deCODE in any of its business areas
that would create a conflict of interest.
2.5.3 At any time during the term of this Agreement, if any
Institution Personnel wishes to seek funding for any research or development
work directly related to the Crosswalk Project, including additional funding for
the Crosswalk Project, from any international, federal or state agencies, or
from any not-for-profit foundations, except foundations owned or operated by a
commercial entity other than deCODE or which have obligations to commercial
entities with respect to such research, such Institution Personnel shall so
notify deCODE's Crosswalk Coordinator, including a description of the research
or development work for which such funding is sought. deCODE shall have thirty
(30) days to review such proposal and decide whether, in the reasonable
determination of deCODE, after consultation with Institutions and the
Institution Personnel, such funding should be sought. No Institution Personnel
shall accept any such funding for any research or development work directly
related to the Crosswalk Project unless approved pursuant to this Section 2.5.3.
In any event, any Institution Personnel shall follow the procedures set forth in
Section 5 with respect to any grant applications and progress reports disclosing
Crosswalk Information.
2.5.4 Institution Personnel shall be free at any time to
seek funding from any source for any research or development work that is not
related or similar to the Crosswalk Project.
3. Payments.
3.1 Payments. deCODE shall pay to the Institutions the sum of up
to [CONFIDENTIAL TREATMENT REQUESTED] to support the Institutions' efforts to
create the Crosswalk, as provided in the Budget. deCODE shall make such payment
in periodic installments to be determined by the JSC. Such payments shall be
made in cash, in kind in the form of goods and services related to the Crosswalk
Project, the value of which shall be determined by the JSC, or both in cash and
in kind. The form of such in kind payments shall be determined by deCODE at its
sole discretion. All of such funding shall be used in the following order: (a)
first, to the extent such payments are in the form of cash, for the support of
the Crosswalk Project Coordinators and the IP Project Leaders during the
Crosswalk Development Period and in the amounts determined by the mutual
agreement of the Parties; (b) second, for costs and expenses incurred by the
Institutions during the Crosswalk Development Period for work conducted pursuant
to the Work Plan; and (c) third, to compensate deCODE for in kind contributions
to the Crosswalk Project, as provided above. All funds paid to the Institutions
shall be used to support the direct and attendant indirect costs
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(as determined by the Institutions' policies on indirect costs, as communicated
to the JSC from time to time) of the Crosswalk Project. All of such funding of
direct costs shall be used by the Institutions as deemed necessary and
appropriate by the JSC to achieve the research goals and objectives set forth in
the Work Plan. All funds advanced to the Institutions under this Agreement and
not used in accordance with the terms hereof shall be promptly refunded to
deCODE.
3.2 Payment Method. All payments made by deCODE shall reference
Agreement number ______. Checks for all payments to the Institutions under this
Agreement shall be made payable to the payees designated by the JSC and
addressed to the contacts set forth in Section 10.
3.3 Payment Records; Audit Rights. Each Institution shall maintain
records of its expenditures and of funds received under this Agreement in
accordance with its customary accounting policies and procedures and shall
provide to deCODE a summary of such expenditures within ninety (90) days after
the end of each elapsed year during the Crosswalk Development Period. During the
Crosswalk Development Period and for two years thereafter, deCODE on reasonable
notice, during normal business hours and at its own expense may examine or audit
each Institution's accounting records with respect to expenditures under this
Agreement, provided however, that in the event that such inspection or audit
reveals an overpayment by deCODE in excess of five percent (5%) of the amount
actually due for the period subject to such audit or examination, such
Institution shall reimburse the cost of the examination or audit in addition to
refunding the excess payment.
4. Crosswalk Intellectual Property Rights.
1.1 Ownership of Intellectual Property.
4.1.1 Each Institution Personnel who shall (i) solely or
jointly make a Crosswalk Invention, or (ii) solely or jointly author or prepare
a Crosswalk Copyrightable Work, shall promptly report such Crosswalk Invention
or Copyrightable Work to the Institution by whom such Institution Personnel is
employed or affiliated. Such Institution Personnel shall assign all of his or
her rights, title and interest in any Crosswalk Patent Right claiming such
Crosswalk Invention, or in any Confidential Information comprised of such
Crosswalk Invention or in any Copyrightable Work to the Institution by which he
or she is employed or affiliated (to the extent that such Copyrightable Work is
not already owned by such Institution as a Work-Made-For-Hire under United
States Copyright Law). Each deCODE Personnel who shall (i) solely or jointly
make a Crosswalk Invention, or (ii) solely or jointly author or prepare a
Crosswalk Copyrightable Work, shall promptly report such Crosswalk Invention or
Copyrightable Work to deCODE. Such deCODE Personnel shall assign all of his or
her rights, title and interest in any Patent Right claiming such Crosswalk
Invention, or in any Confidential Information comprised of such Crosswalk
Invention or in any Copyrightable Work to deCODE (to the extent that such
Copyrightable Work is not already owned by deCODE as a Work-Made-For-Hire under
United States Copyright Law).
4.1.2 If a Crosswalk Invention is invented by one or more
Institution Personnel and one or more deCODE Personnel, such Institution
Personnel and deCODE Personnel shall
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assign all of their respective rights, title and interest in any Crosswalk
Patent Right claiming such Joint Invention to their respective employers with
which they are affiliated (each, a "Joint Crosswalk Patent Right"). For each
Joint Crosswalk Patent Right, the Institution(s) to which such Patent Right is
assigned and deCODE agree that deCODE and such Institution(s) shall each own an
undivided interest in such Patent Right in each country in which it is filed and
granted. Such Institution(s) and deCODE shall each be allowed to sell, license
or otherwise transfer its rights to such Joint Crosswalk Patent Right in any
country without the consent of the other; however, the Institutions' rights in
this respect are subject to the terms and conditions of this Agreement and the
Strategic Alliance Agreement.
4.1.3 If a Crosswalk Invention which is protected as
Confidential Information is invented by one or more Institution Personnel and
one or more deCODE Personnel, such Institution Personnel and deCODE Personnel
shall assign all of their respective rights, title and interest in any
Confidential Information comprising such Joint Invention to their respective
employers with which they are affiliated. For each such joint Confidential
Information, the Institution(s) to whom such Confidential Information is
assigned and deCODE agree that deCODE and such Institution(s) shall each own an
undivided interest in such Confidential Information. Such Institution(s) and
deCODE shall each be allowed to sell, license or otherwise transfer its rights
to such Confidential Information without the consent of the other; however, the
Institutions' rights in this respect are subject to the terms and conditions of
this Agreement and the Strategic Alliance Agreement.
4.1.4 Institutions and deCODE intend and agree that all
Crosswalk Copyrightable Works authored by any of them (or any of their
respective Institution Personnel in the case of the Institutions and deCODE
Personnel in the case of deCODE) be treated as separable and independent works
to the maximum extent possible, and that such works shall not constitute "joint
works" as that term is defined by the United States Copyright Law, or otherwise
be jointly owned under United States law or the law of any foreign jurisdiction.
The Parties agree that all copyright filings and registrations shall be made
consistent with the terms of this Section 4.1.
4.2 Disclosure between Parties. Each Party shall promptly advise
the other in writing of each: (a) Crosswalk Invention, including without
limitation any Joint Invention; or (b) Crosswalk Copyrightable Work, including
without limitation any jointly authored or created Crosswalk Copyrightable Work,
disclosed to it. The IP Project Leaders for the Institutions and deCODE shall
then discuss whether applications for Crosswalk Patent Rights shall be sought
and in which countries, or whether such Crosswalk Invention shall be designated
and treated as Confidential Information, protected as such and made available
exclusively to the Alliance for use by the Parties as provided in the Strategic
Alliance Agreement, and the decisions regarding such matters shall be governed
by the decision-making process set forth in Section 4.7 of the Strategic
Alliance Agreement. If the Parties determine, pursuant to the decision-making
process set forth in Section 4.7 of the Strategic Alliance Agreement, that such
application(s) should be filed, applications assigned solely to any Institutions
shall be filed by such Institutions, applications assigned solely to deCODE
shall be filed by deCODE, and jointly assigned applications shall be filed as
mutually agreed upon by the Parties. The titles, serial numbers and
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other identifying data of any applications for Crosswalk Patent Rights shall be
added to Appendix C of this Agreement.
4.3 Costs. Reasonable and customary costs incurred by Institutions
for filing, obtaining and maintaining Crosswalk Intellectual Property Rights
("IP Costs") shall be reimbursed in full by deCODE upon deCODE's receipt of such
Institution's notice of payment of such IP Costs, except as provided for below.
Such IP Costs shall include but not be limited to the costs of preparing,
filing, prosecuting (including agreed upon interferences or oppositions),
issuing or maintaining and working such Crosswalk Intellectual Property Rights,
including without limitation the Crosswalk Patent Rights and Crosswalk
Copyrightable Works. For IP Costs not reimbursed by deCODE within thirty (30)
days, after receipt of such Institution's notice of payment of such IP Costs,
deCODE shall pay such Institution interest at the rate of [CONFIDENTIAL
TREATMENT REQUESTED] per month compounded each month that they remain unpaid.
For Crosswalk Intellectual Property Rights in which other commercial entities
have acquired license rights, deCODE shall reimburse such Institution only for
the same share of such IP Costs as reimbursed by each of the other commercial
entities, but in no event shall deCODE be required to reimburse such Institution
for more than [CONFIDENTIAL TREATMENT REQUESTED] of the IP Costs for such
Crosswalk Patent Rights.
4.4 Prosecution Notice. With respect to any Crosswalk Intellectual
Property Right, the filing Party shall provide to the other Party's IP Project
Leader each application and communication to and from the authorities which
grant such Crosswalk Intellectual Property Right, including without limitation
each application, office action, response to office action, request for terminal
disclaimer, request for reissue or reexamination of any patent issuing from such
application, and notice of interference or opposition, sufficiently prior to the
filing of such application, response or request to allow for review and comment
by such other Party's IP Project Leader. All decisions regarding such actions
shall be governed by the decision-making process set forth in the Strategic
Alliance Agreement.
4.5 Confidentiality. All information given by deCODE to any
Institution, or by the Institutions to deCODE, in accordance with this Section 4
shall be maintained in confidence for so long as such information remains
unpublished.
4.6 Addition of Embedded Technology. Each Party shall have the
right, but not the obligation, to contribute to the Crosswalk as Embedded
Technology additional technology owned or acquired by such Party outside of the
performance of the Crosswalk Project. In the event a Party desires to contribute
such additional technology, the Parties shall negotiate in good faith to
determine the terms upon which such Party may contribute such technology
(provided that such terms shall include only a non-exclusive right and license
to use such additional technology pursuant to the terms of the Strategic
Alliance Agreement), including the amount of any consideration to be paid for
such additional technology, the effect, if any, of such contribution on the
royalties to be paid by each Party to the other on revenue from the Crosswalk,
subject to approval by the JSC, and whether and to what extent such additional
technology shall serve as in kind funding of the Crosswalk as described in
Section 3.1 of this Agreement; provided, however, that upon the Parties'
agreement, the additional technology shall be listed upon Appendix D and shall
become Embedded Technology subject to the terms of this
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Agreement in all respects. Notwithstanding the forgoing, no Party shall be
compelled by any other Party or any decision-maker under the dispute resolution
provisions of this Agreement or the Strategic Alliance Agreement to contribute
any such additional technology without such Party's prior written consent.
4.7 Rights to Other Technology. Each Party shall own all right,
title and interest in and to any Other Technology developed by such Party.
4.8 Use of Intellectual Property. The Parties agree that all use
by any Party of the Crosswalk, including without limitation, all Crosswalk
Inventions, Crosswalk Copyrightable Work, Copyrights, Crosswalk Patent Rights,
Crosswalk Information and Confidential Information and all use by a Party of
another Party's Other Technology, shall be governed by the terms of the
Strategic Alliance Agreement, and also, in the case of such Other Technology,
the Software License Agreement applicable to such Other Technology. No Party
shall have any right to use the Crosswalk, any Party's Other Technology, any
additional technology owned or acquired by a Party outside of the Crosswalk
Project, or any component of any of the foregoing, including any Crosswalk
Intellectual Property Right which may be owned by such Party, except as
specifically provided in, and subject to the terms and conditions of, the
Strategic Alliance Agreement and, in the case of such Other Technology, the
Software License Agreement applicable to such Other Technology.
5. Publications.
5.1 Submission. Prior to public presentation or submission to a
journal, international, federal or state agency, or not-for-profit foundation,
as the case may be, each Institution Personnel shall agree to submit for review
to deCODE's Crosswalk Coordinator, and each deCODE Personnel shall agree to
submit for review to Institutions' Crosswalk Coordinator, an early draft of any
manuscript, abstract, public oral presentation containing Crosswalk Information.
5.2 Review Period. Within thirty (30) days of receipt of such
manuscript or seven (7) days after receipt of an abstract or public oral
presentation from an Institution Personnel or a deCODE Personnel, the other
Party's Crosswalk Coordinator shall submit such Party's comments, if any, to
such Institution Personnel or deCODE Personnel, as the case may be. Such
Institution Personnel or deCODE Personnel shall give due consideration to any
comments made by the other Party, but shall not be required to incorporate any
of the other Party's comments, and the Institution Personnel's or deCODE
Personnel's decision as to what such manuscript, presentation, or abstract shall
contain shall be final, except that upon notification from the other Party, such
Institution Personnel or deCODE Personnel shall delete all Confidential
Information of the other Party. In any publication or presentation involving the
Crosswalk, each Party shall acknowledge the role and contribution of the other
Party to the project to which the publication or presentation relates.
5.3 Delay for Patent Filing. If the reviewing Party has reason to
believe that any such manuscript, abstract or grant application provided in
accordance with Section 5.5 reveals a potentially patentable Crosswalk
Invention, such Party shall notify the other Party's IP Project
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Leader in writing within the time periods indicated in Section 5.2, 5.3 or 5.5,
as the case may be. In such case, the publishing Party agrees to delay
publication or public presentation until the earlier to occur of the following:
5.3.1 A Crosswalk Patent Right is filed in the appropriate
country for initial filing under the laws of the country in which such Crosswalk
Invention is made (i.e., Crosswalk Inventions made in the U.S. shall be filed
first in the U.S. unless the procedures set forth in 35 U.S.C. Section 184 are
complied with;
5.3.2 The IP Project Leaders have determined, pursuant to
the decision-making process set forth in the Strategic Alliance Agreement, that
no patentable Crosswalk Invention exists; or
5.3.3 Sixty (60) days have passed from the date of such
notification by the reviewing Party.
5.4 Competitive Publications. If any deCODE Personnel or
Institution Personnel receives reasonable indications concerning the imminent
oral presentation or publication of a manuscript or abstract by a third party
that is similar in content to the presentation, manuscript and/or abstract
containing Crosswalk Information proposed to be published or presented by such
deCODE Personnel or Institution Personnel, the Parties agree as follows: (a)
such deCODE Personnel or Institution Personnel shall notify their own and the
other Party's Crosswalk Coordinator in writing as soon as reasonably practical
about such other imminent presentation or publication; and (b) the time periods
for presentation or publication review and delay stated in Sections 5.1, 5.2 and
5.3 shall be shortened as mutually agreed.
5.5 Grant Submissions. Subject to approval pursuant to Section
2.5.3, Institution Personnel shall have the right to submit grant applications
related to the Crosswalk Project and/or disclosing any Crosswalk Information or
the nature of the relationship among the Parties to any international, federal
and/or state agencies or not-for-profit foundations which do not require
licensing to a commercial entity; provided, however, that such Institution
Personnel shall provide a draft of such grant applications to deCODE at least
fifteen (15) days prior to submission to such agencies or foundations. In the
event that an Institution Personnel wants to exclude from review any portions of
a grant application that do not disclose any Crosswalk Information or the nature
of the relationship among the Parties, then such Institution Personnel shall
provide to deCODE: (i) a draft of all other portions of such grant application,
including all portions disclosing any Crosswalk Information or the nature of
such relationship; and (ii) a certification from the Institution Personnel
submitting such grant application and Institutions' IP Project Leader that
deCODE has been provided with all portions of such grant application disclosing
Crosswalk Information and the nature of such relationship, and all portions
reasonably necessary for deCODE to determine whether such grant application
reveals a Crosswalk Invention. In such event, deCODE may request additional
information as it deems reasonably necessary or desirable to make such a
determination. Such grant submission shall be subject to Section 5.3. When so
requested by deCODE, Institutions and Institution Personnel shall indicate on
such grant application that certain proprietary business information is
contained therein which
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is not subject to disclosure under the Freedom of Information Act, and shall
request that such information be treated as confidential.
6. Confidentiality.
6.1 Confidentiality Obligation. Except as otherwise provided in
Section 6.2, during the term of this Agreement and for a period of ten (10)
years thereafter, each Party agrees to use reasonable efforts not to disclose to
third parties any Confidential Information disclosed to it by the other Party.
6.2 Permitted Disclosures. Nothing in this Agreement shall limit
any Party in any way from: (a) disclosure of information required by a public
authority; or (b) disclosure of information that is necessary to prevent
imminent danger to the public; provided, however, in each case the disclosing
Party shall promptly inform the other Party of its intent to disclose such
information and the reasons for such disclosure.
6.3 Exceptions. Information received from the other Party hereto
shall not be deemed Confidential Information, and the receiving Party shall have
no obligation of confidentiality with respect to such information which:
6.3.1 As of the Effective Date, is part of the public
domain;
6.3.2 Subsequently becomes part of the public domain
through no fault of the receiving Party;
6.3.3 The receiving Party can show was in its possession,
as evidenced by written records kept in the ordinary course of business or by
the proof of actual use at the time of executing this Agreement, and which
information had not been wrongfully acquired, directly or indirectly, from the
disclosing Party;
6.3.4 Is subsequently disclosed to the receiving Party by a
third party not in violation of any right of, or obligation to, the other Party
hereto;
6.3.5 Is required to be disclosed by operation of law,
provided that the receiving Party has given advanced notice of the proposed
disclosure to the disclosing Party; or
6.3.6 Is developed by or on behalf of the receiving Party
without reference to the disclosing Party's Confidential Information, as
evidenced by written records.
6.4 Injunctive Relief. In addition to any other right or remedy it
may have and without the posting of any bond or other security, each Party shall
be entitled to seek injunctions to enjoin or restrain the other Party from any
violation or threatened violation of this Section 6.
7. Publicity and Advertising.
No Party shall, without the prior written consent of the other Party,
use in endorsement,
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advertising, publicity, or otherwise, the name, trademark, logo, symbol, or
other image of the other Party or such Party's employees or agents. Each Party
agrees that its name may be used: (a) whenever required by law or regulation,
including without limitation disclosure to the Securities and Exchange
Commission, provided, however, that a Party using another Party's name shall, to
the extent reasonably practicable as solely determined by such using Party,
provide a copy of such proposed disclosure to such other Party in advance and
give consideration to such other Party's comments and requests regarding such
disclosure, but shall not be obligated to perform any act or omission in
response to such comments or requests; (b) by deCODE in connection with its
capital raising and financing purposes, based upon standard statements
established by the mutual agreement of the Parties; (c) to make a joint,
mutually agreeable public announcement about the initiation of the relationship
and the support of the Crosswalk hereunder; and (d) to make routine
acknowledgments of the relationship, support of the Crosswalk hereunder and the
basic substance of the relationship, based upon standard statements established
by the mutual agreement of the Parties. If no such standard statements have been
established, then the disclosing Party shall provide the non-disclosing Party
with an opportunity to review, comment on and approve the disclosure in advance
of making such disclosure. Nothing in this Section 7 shall preclude deCODE's use
of Institutions' names, trademarks, logos, symbols, or other images in
connection with the marketing and sale of products and services pursuant to this
Agreement, provided that any such use shall remain subject to the approval of
the Public Affairs Officer of the Institution whose name, trademark, logo,
symbol or other image is so used.
8. Termination.
8.1 Breach by deCODE. If deCODE fails to meet any of its material
obligations under this Agreement and shall fail to remedy these failures within
sixty (60) days after receipt of written notice thereof, the Institutions shall
have the option of terminating this Agreement upon their mutual agreement and
upon written notice thereof; provided, however, that deCODE shall have the right
to cure such default during such sixty (60) day period.
8.2 Breach by Institution. If any Institution fails to meet any of
its material obligations under this Agreement and shall fail to remedy these
failures within sixty (60) days after receipt of written notice thereof, deCODE
shall have the option of terminating this Agreement upon written notice thereof
to all Institutions; provided, however, that such Institution shall have the
right to cure such default during such sixty (60) day period.
8.3 Termination by deCODE for Infeasibility. In the event that
deCODE determines that the Crosswalk Project is scientifically or economically
not feasible or no longer is consistent with deCODE's business strategy, deCODE
may terminate this Agreement at any time during the Crosswalk Development Period
by giving written notice of termination to Institutions thirty (30) days prior
to the effective date of such termination.
8.4 Termination by deCODE for Other Reasons. In the event that the
Strategic Alliance Agreement is terminated by deCODE pursuant to Section 10.5
thereof, then this Agreement shall also be deemed to be terminated upon the
effective date of such termination of the Strategic Alliance Agreement.
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8.5 Effect of Termination.
8.5.1 In the event that this Agreement is terminated by the
Institutions pursuant to Section 8.1, by deCODE pursuant to Section 8.3 or by
deCODE pursuant to Section 8.4 following a deCODE Notice under the Strategic
Alliance Agreement, deCODE shall reimburse the Institutions for contractual
commitments and financial obligations incurred by such Institutions during the
Crosswalk Development Period if such financial obligations or contractual
commitments cannot reasonably be cancelled by such Institutions. The
Institutions shall use their best efforts to terminate or cancel all contractual
commitments and other financial obligations as soon as possible to avoid
incurring additional expenses.
8.5.2 In the event that this Agreement is terminated by
deCODE pursuant to Section 8.3:
(a) The Institutions shall use all reasonable
efforts to immediately commence winding down the Crosswalk Project upon receipt
of such notice of termination from deCODE; and
(b) deCODE shall reimburse the Institutions for
the direct salary costs incurred by the Institutions, for a period of six months
after the effective date of such termination, of any M.D., Ph.D. or equivalent
information technology personnel who is deriving 50% or more of his or her
salary from the Crosswalk Project being funded by deCODE during the three month
period preceding the notice of termination.
8.5.3 In the event that this Agreement is terminated by
deCODE pursuant to Section 8.2, all funding obligations of deCODE shall cease as
of the effective date of such termination.
8.5.4 In the event that this Agreement is terminated by
deCODE pursuant to Section 8.4 following an Institution Notice under the
Strategic Alliance Agreement:
(a) All funding obligations of deCODE shall
cease immediately upon receipt of notice of such termination of the Strategic
Alliance Agreement; and
(b) The Institutions shall use all reasonable
efforts to immediately commence winding down the Crosswalk Project upon receipt
of such notice of termination from deCODE.
8.5.5 Upon the early termination of this Agreement during
the Crosswalk Development Period pursuant to Section 8.1, 8.2, 8.3 or 8.4 or in
the event of the expiration of the Crosswalk Development Period under this
Agreement, the Parties' rights and obligations with respect to Confidential
Information and the use of the Crosswalk Intellectual Property Rights shall be
governed by the Strategic Alliance Agreement, and the Parties' rights and
obligations with respect to the Other Technology shall be governed by the
Software License Agreement applicable to such Other Technology.
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9. Alternative Dispute Resolution.
9.1 Negotiation. The Parties shall attempt in good faith to
resolve, through negotiation, any dispute, claim or controversy arising out of
or relating to this Agreement. Any Party may initiate negotiations by providing
written notice in letter form to the other Parties, setting forth the subject of
the dispute and the relief requested. The recipient of such notice shall respond
within five (5) days with a written statement of its position on, and
recommended solution to, the dispute. If the dispute is not resolved by this
exchange of correspondence, then representatives of each Party with full
settlement authority shall meet at a mutually agreeable time and place within
ten (10) days of the date of the initial notice in order to exchange relevant
information and perspectives, and to attempt to resolve the dispute.
9.2 Arbitration. Except with respect to breaches for which a Party
is seeking injunctive relief, all disputes between the Parties relating to this
Agreement or the subject matter hereof which cannot be resolved by the Parties
according to Section 9.1 shall be submitted for final and binding arbitration
before JAMS/Endispute ("JAMS") pursuant to the United States Arbitration Act, 9
U.S.C. Section 1 et seq., and shall be held at a mutually agreeable location or
in New York City. Any Party may commence the arbitration process pursuant to
this Agreement by filing a written demand for arbitration with JAMS, with a copy
to the other Parties. Unless the Parties otherwise agree in writing, the
arbitration shall be conducted in accordance with the provisions of JAMS
Comprehensive Arbitration Rules and Procedures in effect at the time of filing
of the demand for arbitration if the amount in controversy is greater than
$250,000, exclusive of interest; or the arbitration shall be conducted in
accordance with the provisions of JAMS Streamlined Arbitration Rules and
Procedures in effect at the time of filing of the demand for arbitration if the
amount in controversy is $250,000 or less, exclusive of interest. The Parties
shall cooperate with JAMS and with one another in selecting an arbitrator from
JAMS' panel of neutrals, and in scheduling the arbitration proceedings;
provided, however, that all arbitrators must be knowledgeable in the
biotechnology and bioinformatics industries and, in the case of a dispute
concerning the Crosswalk, the software development industry, and must not be
affiliated through employment or otherwise with a competitor of any Party, as
determined through mutual assent of the Parties. The Parties shall participate
in the arbitration in good faith, and shall share equally in its costs. The
provisions of this Section may be enforced by any court of competent
jurisdiction, and the Party seeking enforcement shall be entitled to an award of
all costs, fees and expenses, including attorneys' fees, to be paid by the Party
against whom enforcement is ordered.
9.3 Injunctive Relief. This Section 9 shall not prohibit a Party
from seeking injunctive relief from a court of competent jurisdiction in the
event of a breach or prospective breach of this Agreement by any other Party
which would cause irreparable harm to the first Party.
10. Miscellaneous.
10.1 Governing Law. This Agreement shall be governed by, construed,
and interpreted in accordance with the laws of the State of Delaware, without
reference to principles of conflicts of laws.
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10.2. Independent Contractors. No Party shall have the right to
direct or control the activities of any other Party or other Party's personnel
in the Crosswalk Project, and each Party shall act hereunder only as an
independent contractor; nothing herein contained shall be construed to be
inconsistent with that relationship or status. Under no circumstances shall
Institution or any Institution Personnel be considered to be an employee or
agent of deCODE, or deCODE or any deCODE Personnel be considered any employee or
agent of any Institution. This Agreement shall not constitute, create, or in any
way be interpreted as a joint venture, partnership or formal business
organization of any kind.
10.3 Assignment. No Party shall assign its rights or duties under
this Agreement to another without the prior express written consent of the other
Parties, which consent shall not be unreasonably withheld; provided, however,
that any Party may assign this Agreement to a successor in ownership of all or
substantially all its business assets. Such successor shall expressly assume in
writing the obligation to perform in accordance with the terms and conditions of
this Agreement.
10.4 Notices. All notices, demands, payments and other
communications of every kind and description whatsoever required or permitted
under this Agreement shall be in writing and shall be deemed to have been
received when personally delivered, or when shipped by private express carrier
(signature required), shipment charges prepaid, or when sent via facsimile
transmission (receipt verified) to the Party to whom delivery shall be made at
the respective addresses as set out below.
If to Partners, to: With a copy to:
Partners HealthCare System, Inc. Partners HealthCare System, Inc.
Prudential Tower, 000 Xxxxxxxx Xxxxxx Prudential Tower, 000 Xxxxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx, 00000-0000 Xxxxxx, Xxxxxxxxxxxxx, 00000-0000
Attn: Crosswalk Coordinator Attn: Vice President, Corporate Sponsored Research and
Institution Agreement #________ Licensing
Telephone: (000) 000-0000 Telephone: (000) 000-0000
Facsimile: (000) 000-0000 Facsimile: (000) 000-0000
If to MGH, to: If to BWH, to:
Massachusetts General Hospital The Xxxxxxx and Women's Hospital, Inc.
000 00xx Xxxxxx, Xxxxx 0000 0000 Xxxxxxxx Xx., Xxxxx 000 Xxxxxx, XX 2215
Xxxxxxxxxxx, XX 00000 Attn: Director, Corporate Sponsored Research and
Attn: Director, Corporate Sponsored Research and Licensing Licensing
Institution Agreement #2000A001263 Institution Agreement #A3329
Telephone: (000) 000-0000 Telephone: (000) 000-0000
Facsimile: (000) 000-0000 Facsimile: (000) 000-0000
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If to deCODE, to:
deCODE genetics Ltd.
Xxxxxxxxx 0
XX-000 Xxxxxxxxx, Xxxxxxx
Attn: Crosswalk Coordinator
Telephone: x000-000-0000
Facsimile: x000-000-0000
10.5 Modification. No modification or waiver of this Agreement or
of any covenant, condition, or limitation herein contained shall be valid unless
in writing and duly executed by all Parties.
10.6 Waiver. No waiver of any rights shall be effective unless
assented to in writing by the Party to be charged with such waiver, and the
waiver of any breach or default shall not constitute a waiver of any other right
hereunder or any subsequent breach or default.
10.7 Headings. The Section headings herein are for convenience only
and shall not affect the construction or interpretation of this Agreement.
10.8 Severability. In the event that any provision of this
Agreement becomes or is declared by a court of competent jurisdiction to be
illegal, unenforceable or void, this Agreement shall continue in full force and
effect without said provision; provided however, that no such severability shall
be effective if the result of such action materially changes the economic
benefit of this Agreement to deCODE or to Institutions.
10.9 Construction. The Parties have participated equally in the
creation of this Agreement; the language of this Agreement shall not be
presumptively construed against either Party.
10.10 Survival. The provisions of Sections 1, 3.3, 4, 5, 6, 7, 8.5,
9, 10.1, 10.8, 10.9 and 10.10 shall survive any expiration or termination of
this Agreement.
10.11 Counterparts. This Agreement may be executed in counterparts,
each of which shall constitute an original document, but all of which together
shall constitute one and the same agreement.
***
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In witness whereof, each of the Institutions and deCODE have caused this
Agreement to be executed by their duly authorized representatives as of the date
first set forth above.
PARTNERS HEALTHCARE SYSTEM, INC. DECODE GENETICS LTD.
BY: __/s/ Xxxxxx Braunwald_______ BY: ___/s/ Xxxx Stefansson________
NAME: __Eugene Braunwald_______ NAME: ___Kari Stefansson________
TITLE: __V.P. Academic Programs__ TITLE: __President and CEO_______
DATE: ___ 5/16/2000_____________ DATE: ___5/11/2000_____________
THE GENERAL HOSPITAL CORPORATION THE XXXXXXX AND WOMEN'S HOSPITAL,
D.B.A. MASSACHUSETTS GENERAL HOSPITAL INC.
BY: __/s/ Xxxxxx X. Guthrie______ BY: ___/s/ Xxxxx X. Hicks_________
NAME: __Marvin C. Xxxxxxx, X.X._ NAME: ___Brian N. Hicks_________
TITLE: _V.P. Patents, Licensing__ TITLE: ____Director, Corporate____
and Industry Sponsored Sponsored Research
Research and Licensing
DATE: _11_May_2000_________ DATE: ___5/12/2000______________
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APPENDIX A
WORK PLAN
(see attached)
000
XXXXXXXX X
BUDGET
(see attached)
171
APPENDIX C
LIST OF INTELLECTUAL PROPERTY RIGHTS
(to be prepared and updated from time to time)
PARTNERS HEALTHCARE SYSTEM, INC. DECODE GENETICS LTD.
BY: _____________________________ BY: ______________________________
NAME: __________________________ NAME: ___________________________
TITLE: __________________________ TITLE: ___________________________
DATE: __________________________ DATE: ___________________________
THE GENERAL HOSPITAL CORPORATION THE XXXXXXX AND WOMEN'S HOSPITAL,
D.B.A. MASSACHUSETTS GENERAL HOSPITAL INC.
BY: _____________________________ BY: ______________________________
NAME: __________________________ NAME: ___________________________
TITLE: __________________________ TITLE: ___________________________
DATE: __________________________ DATE: ___________________________
000
XXXXXXXX X
LIST OF EMBEDDED TECHNOLOGY
(to be prepared and updated from time to time)
PARTNERS HEALTHCARE SYSTEM, INC. DECODE GENETICS LTD.
BY: _____________________________ BY: ______________________________
NAME: __________________________ NAME: ___________________________
TITLE: __________________________ TITLE: ___________________________
DATE: __________________________ DATE: ___________________________
THE GENERAL HOSPITAL CORPORATION THE XXXXXXX AND WOMEN'S HOSPITAL,
D.B.A. MASSACHUSETTS GENERAL HOSPITAL INC.
BY: _____________________________ BY: ______________________________
NAME: __________________________ NAME: ___________________________
TITLE: __________________________ TITLE: ___________________________
173
DATE: __________________________ DATE: ___________________________
174
[DECODE GENETICS GRAPHIC]
[PARTNERSHEALTHCARE GRAPHIC] Xxxxxxxxx 0
XX-000 Xxxxxxxxx
XXXXXXX
Phone: (000) 000-0000
Fax: (000) 000-0000
E-mail: xxxx@xxxxxx.xx
Web Page: xxx.xxxxxx.xx
FOR IMMEDIATE RELEASE
PARTNERS HEALTHCARE AND DECODE GENETICS
JOIN FORCES AGAINST DISEASE
Reykjavik, Iceland, and Boston, Massachusetts, May 25, 2000 -- Partners
HealthCare System Inc. (xxx.xxxxxxxx.xxx), founded by the Massachusetts General
and Xxxxxxx and Women's hospitals, and deCODE genetics (xxx.xxxxxx.xxx), the
Icelandic genomics company, today announced the signing of a broad-based
strategic research agreement. Through a better understanding of the genetic
components of disease, the alliance aims to pioneer new diagnostic and
therapeutic approaches to common illnesses and to develop leading-edge
bio-informatics that can improve the quality of healthcare.
The three-year agreement includes research and business collaborations in three
distinct areas. First, the alliance will enable Partners and deCODE scientists
to form joint research teams to identify and compare disease-causing genes or
loci responsible for diseases in both the Icelandic and Massachusetts
populations. Second, the two entities will be able to collaborate on basic
research related to these new genes and on the discovery of novel approaches to
preventing and treating common diseases. Third, deCODE will provide Partners
with healthcare informatics systems resulting from deCODE's development of the
Icelandic Health Sector Database (IHD). These technologies will strengthen
Partners' existing information system infrastructure, enabling a more
comprehensive population-based approach for its genetics research and
facilitating collaborations between the two parties. deCODE has the right to
develop and market products and services resulting from the collaborative
research programs.
The alliance expects to capitalize upon ongoing work to sequence the human
genome. It thus represents an opportunity for academia and industry to work
together and turn raw genomics data into practical knowledge that can
significantly improve health and healthcare delivery. The relationship will
leverage both deCODE's expertise in population genomics - a field applying
genetic and molecular biology techniques to populations in order to identify the
genetic components of disease - and the genetics and medical expertise of
Partners' scientific staff. Most importantly, clinical researchers from both
parties will be able to employ leading science and bio-informatics technology to
compare the occurrence of disease-causing genes within the small, homogeneous
Icelandic population and Partners' highly diverse patient base in the Boston
area.
Xx. Xxxxxx X. Thier, President and CEO of Partners said: "Strengthening our
ability to understand the genetic causes of disease can enhance the quality of
the healthcare we provide to our patients. This relationship with deCODE brings
Partners the tools and technology to help translate modern genetic advances to
the patient bedside."
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PARTNERS HEALTHCARE AND DECODE JOIN FORCES AGAINST DISEASE...PAGE 2 OF 2
Dr. Xxxx Xxxxxxxxxx, CEO of deCODE genetics, said: "This collaboration will
provide a unique opportunity for our scientists to integrate the discoveries we
make in Iceland with the best of the American healthcare system."
deCODE genetics is a genomics and health informatics company developing products
and services for the healthcare industry. Through its population-based genomics
approach and data-mining techniques, deCODE seeks to transform raw genomics data
into marketable knowledge about human health and disease, and to develop
vanguard medical informatics technology.
Partners HealthCare System, Inc. is an integrated healthcare delivery system
based in Boston. The system includes primary care physicians and specialists,
community hospitals, the two founding academic medical centers and other
health-related entities. The member organizations of Partners are dedicated to
enhancing patient care, teaching and research, and to taking a leadership role
as an integrated healthcare system.
###
Contacts:
Xxxxx Xxxxxxx Xxxxxxxx Xxxxxx
Xxxxxx/Xxxxx Ltd. Partners Healthcare
x00 (0) 000 000 0000 x0 000 000 0000
xxxxx.xxxxxxx@xxxxxxxxxxx.xxx xxxxxxx@xxxxxxxx.xxx
176
SOFTWARE LICENSE AGREEMENT
BETWEEN
PARTNERS HEALTHCARE SYSTEM, INC.,
THE GENERAL HOSPITAL CORPORATION,
D.B.A. MASSACHUSETTS GENERAL HOSPITAL,
THE XXXXXXX AND WOMEN'S HOSPITAL, INC.
AND
deCODE GENETICS LTD.
DATED ____________, 2000
177
SOFTWARE LICENSE AGREEMENT
THIS SOFTWARE LICENSE AGREEMENT (together with all schedules and
appendices, this "Agreement"), dated as of ____________, 2000 ("Effective
Date"), by and among Partners HealthCare System, Inc., a Massachusetts
not-for-profit corporation with its principal place of business at Prudential
Tower, 000 Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx, 00000-0000 ("Partners"); The
General Hospital Corporation d.b.a. Massachusetts General Hospital, a
Massachusetts not-for-profit corporation having its principal offices at 00
Xxxxx Xxxxxx, Xxxxxx, XX 00000 ("MGH"); The Xxxxxxx and Women's Hospital, Inc.,
a Massachusetts not-for-profit corporation having its principal offices at 00
Xxxxxxx Xxxxxx, Xxxxxx, XX 00000 ("BWH") (collectively with Partners and MGH,
the "Institutions"); and deCODE genetics Ltd., an Icelandic corporation which is
a wholly-owned subsidiary of deCODE genetics, Inc., a Delaware corporation, and
having its principal offices at Xxxxxxxxx 0, XX-000 Xxxxxxxxx, Xxxxxxx
("deCODE"). Partners, MGH, BWH and deCODE are each, individually, a "Party" and,
collectively, the "Parties".
PRELIMINARY STATEMENTS
A. deCODE is building a database based on phenotypic healthcare
information that deCODE is collecting using the homogeneous Icelandic population
(the "Icelandic Healthcare Database" or "IHD") and a database based on genotypic
information that deCODE intends to collect (the "deCODE Genotype Database" and
collectively with the IHD, the "deCODE Database"). Institutions are creating a
database based on the phenotypic and genotypic information that Institutions are
collecting in connection with internal research using various heterogeneous
populations ("Research Patient Data Registry" or "RPDR") (the deCODE Database
and the RPDR are individually referred to as a "Database" and collectively
referred to as the "Databases").
B. Institutions and deCODE have entered into an alliance agreement (the
"Strategic Alliance Agreement") to create an information technology bridge
described in the Strategic Alliance Agreement as the Crosswalk, to facilitate
studies with the deCODE Database and the RPDR, and to develop new products and
services relating to the use of the Crosswalk for future pharmaceutical and
biotechnology applications.
C. To create the Crosswalk, the Parties have agreed to develop and
contribute Crosswalk Technology pursuant to the Crosswalk Development Agreement.
In addition to Crosswalk Technology, deCODE has developed or is developing
certain other technology outside the scope of the Crosswalk, to which
Institutions wish to obtain a license.
D. deCODE is willing to grant Institutions such a license, and
Institutions are willing to accept such a license to such other technology, upon
the terms and conditions set forth in this Agreement.
Institutions and deCODE have, therefore, agreed as follows:
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1. Definitions.
1.1 "BWH" shall have the meaning assigned to such term in the
Introductory paragraph.
1.2 "Clinical Trial Agreement" shall have the meaning assigned to such
term in the Strategic Alliance Agreement.
1.3 "Confidential Information" shall have the meaning assigned to such
term in Section 5.1.
1.4 "Crosswalk" shall have the meaning assigned to such term in the
Strategic Alliance Agreement.
1.5 "Crosswalk Development Agreement" shall have the meaning assigned
to such term in the Strategic Alliance Agreement.
1.6 "Databases" shall have the meaning assigned to such term in the
Background section.
1.7 "deCODE" shall have the meaning assigned to such term in the
Introductory paragraph.
1.8 "deCODE Database" shall have the meaning assigned to such term in
the Background section.
1.9 "deCODE Notice" shall have the meaning assigned to such term in the
Strategic Alliance Agreement.
1.10 "Disclosing Party" shall have the meaning assigned to such term in
Section 5.1.
1.11 "Documentation" means the textual or graphical materials and
instructions, if any, whether in written or electronic medium, provided by
deCODE for use in connection with the Program.
1.12 "Effective Date" shall have the meaning assigned to such term in
the Introductory paragraph.
1.13 "Icelandic Healthcare Database" or "IHD" shall have the meaning
assigned to such term in the Background section.
1.14 "Institution" and "Institutions" shall have the meanings assigned
to such terms in the Introductory paragraph.
1.15 "Institution Inventions" shall have the meaning assigned to such
term in Section
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2.4.
1.16 "Institution Notice" shall have the meaning assigned to such term
in the Strategic Alliance Agreement.
1.17 "Internal Research" shall mean research conducted by Institutions
in connection with Institutions' education and patient care objectives that is
funded by national or federal grants or public or private foundations which have
no obligations with respect thereto to commercial entities. Internal Research
shall specifically not include, without limitation, any research conducted at or
by Institutions pursuant to funding or sponsorship by any commercial third party
or by any private or public foundation with obligations with respect thereto to
a commercial entity.
1.18 "JAMS" shall have the meaning assigned to such term in Section
7.2.
1.19 "Licensed Materials" shall mean the Program and Documentation,
collectively.
1.20 "Licensed Technology" shall mean the design, source code,
algorithms, flowcharts and diagrams, if any, whether in written or electronic
medium, and the like) identified on Appendix B attached, but does not include
the Program or the Documentation. Other Technology also excludes any information
output derived from the use of the Program.
1.21 "MGH" shall have the meaning assigned to such term in the
Introductory paragraph.
1.22 "Other Technology" shall mean the Licensed Materials and the
Licensed Technology, collectively.
1.23 "Partners" shall have the meaning assigned to such term in the
Introductory paragraph.
1.24 "Party" and "Parties" shall have the meanings assigned to such
terms in the Introductory paragraph.
1.25 "Program" means the software program, in object code format only,
and such other information, all as identified on Appendix A attached, and all
updates, de-bugs, improvements and enhancements thereto that deCODE provides to
Institutions pursuant to Section 2.3.
1.26 "Receiving Party" shall have the meaning assigned to such term in
Section 5.1.
1.27 "Research Patient Data Registry" or "RPDR" shall have the meaning
assigned to such term in the Background section.
1.28 "Sponsored Research Agreement" shall have the meaning assigned to
such term in the Strategic Alliance Agreement.
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1.29 "Strategic Alliance Agreement" shall have the meaning assigned to
such term in the Background section.
1.30 "Third Party Software" shall have the meaning assigned to such
term in Section 3.4.
2. License Grants; Delivery of Other Technology.
2.1 By deCODE for Licensed Materials. deCODE hereby grants Institutions
a non-exclusive, non-transferable, royalty-free, perpetual (unless this
Agreement is terminated pursuant to Section 6.1) right and license, without the
right to grant sublicenses, during the term of this Agreement to use the
Licensed Materials as follows:
2.1.1 For the period beginning on the Effective Date and
ending eighteen (18) months after the Effective Date (the "Installation
Period"), Institutions shall use the Licensed Materials solely for purposes of
developing the Crosswalk and for Internal Research.
2.1.2 Upon the expiration of the Installation Period, provided
that Institutions have complied with all terms and conditions of this Agreement,
the Strategic Alliance Agreement and the Crosswalk Development Agreement,
Institutions shall have the right to use the Licensed Materials for any purpose,
except as otherwise provided in Section 3.2 and in this Section 2.1.2(a) and
(b):
(a) Institutions shall not have the right to sell,
sublicense or distribute the Licensed Materials; and
(b) Institutions shall not have the right to install
or transfer the Licensed Materials to a physical location outside of
Institutions' facilities.
2.2 By deCODE for Licensed Technology. To the extent that Institutions
desire any Licensed Technology, or deCODE believes that Institutions need any
Licensed Technology and Institutions agree, deCODE shall provide such Licensed
Technology (in written or electronic medium), such Licensed Technology shall be
described on Appendix B attached, and deCODE hereby grants Institutions a
non-exclusive, non-transferable, royalty-free, perpetual (unless this Agreement
is terminated pursuant to Section 6.1) right and license, without the right to
grant sublicenses, during the term of this Agreement to use such Licensed
Technology solely to the extent necessary to use the Licensed Materials. All
prohibitions and restrictions on use of the Licensed Materials as provided in
Section 2.1 shall apply to such Licensed Technology.
2.3 De-Bugs and Updates. deCODE shall provide Institutions, pursuant to
this Agreement, with all de-bugs and updates with respect to the Program, in
object code only, and related Documentation, if any, that deCODE may own or
control and that is reasonably necessary to the development and use of the
Crosswalk during the Installation Period, at no additional cost or expense to
Institutions. To the extent deCODE creates any de-bugs or updates during the
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Installation Period that are not reasonably necessary to the development and use
of the Crosswalk, or any material improvements of or enhancements to the
Program, deCODE and Institutions shall negotiate in good faith the right to
obtain same under terms that are mutually acceptable to the Parties.
Institutions hereby acknowledge receipt of one machine-readable copy of the
Program and Documentation in existence as of the Effective Date.
2.4 By Institutions. Institutions hereby grant deCODE a co-exclusive
(with Institutions), royalty-free, perpetual right and license, with the right
to grant sublicenses, to make, have made, use, offer to sell, sell and have sold
all alterations, modifications and improvements to the Other Technology created
or developed during the term of this Agreement by any of the Institutions'
professional staff, graduate students, undergraduate students, employees or
consultants who have access to the Other Technology (collectively, the
"Institution Inventions"), whether or not entitled to copyright, patent or other
protection. Each Institution shall promptly disclose all Institution Inventions
to deCODE.
3. Agreements, Responsibilities of Institutions.
3.1 Ownership. Each Institution acknowledges and agrees that
Institutions shall obtain only the specific, limited rights granted under this
Agreement and that all other right, title and interest in and to the Other
Technology and all derivatives thereof, as well as all patents, patent
applications, copyrights, trade secrets, trademarks or other proprietary rights
with respect thereto, except Institution Inventions, are, and shall continue to
be, owned solely by deCODE. deCODE acknowledges and agrees that all right, title
and interest in and to Institution Inventions, as well as all patents, patent
applications, copyrights, trade secrets, trademarks or other proprietary rights
with respect thereto, are, and shall continue to be, owned solely by
Institutions, subject to the license granted to deCODE in Section 2.4.
3.2 Negative Covenants. Except to the extent expressly authorized by
this Agreement, Institutions shall not:
3.2.1 Convert the Licensed Technology to another programming
language;
3.2.3 Alter or remove any of deCODE's proprietary rights
notices that appear in or on the Other Technology;
3.2.4 Reproduce, distribute, encumber, sell, rent, lease,
sublicense or otherwise transfer rights to the Other Technology;
3.2.5 Decompile, disassemble, reverse engineer or otherwise
derive any source code of the Other Technology, or attempt to do so, or assist
others in doing so or attempting to do so;
3.2.6 Use, reproduce or emulate any trademarks, logos, trade
dress or other proprietary devices of deCODE (collectively, the "Marks") that
identify deCODE as the origin of the Other Technology, except as expressly
required in this Agreement;
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3.2.7 Take any action to jeopardize, limit or interfere in any
manner with deCODE's ownership of or rights with respect to the Other
Technology; or
3.2.8 Violate or fail to comply with all laws or regulations
applicable to the exploitation of Institutions' rights, and the fulfillment of
Institutions' obligations, under this Agreement (including, without limitation,
the applicable export control laws of any jurisdiction).
3.3 Selection of Other Technology. Institutions accept responsibility
for selection of the Other Technology to achieve Institutions' intended results
and, except as expressly provided in Section 4.2, for any loss or damage caused
by Institutions' use of the Other Technology.
3.4 Obtaining Third Party Licenses. Each Institution acknowledges that
the Other Technology is in part designed to collect and organize the output from
software developed and/or owned by third parties (the "Third Party Software")
and that the right and license granted under this Agreement do not pertain to
the Third Party Software. Therefore, each Institution acknowledges and agrees
that such Institution shall be solely responsible for obtaining all licenses
that are necessary or appropriate to allow such Institution to use the Third
Party Software in conjunction with the Other Technology.
3.5 Use of deCODE's Marks by Institutions. Institutions shall use
deCODE's name and/or Marks, as directed and approved from time to time by
deCODE, in connection with its use of deCODE's Other Technology in performance
of any services for a third party using the Other Technology or in connection
with any publication concerning results or services using deCODE's Other
Technology. Institutions acknowledge and agree that such use is intended to
advise third parties of Institutions' use of the Other Technology.
3.6 Use of Institutions' Name by deCODE. deCODE shall have the right,
but not the obligation, to use Institutions' names and refer to Institutions'
use of deCODE's Other Technology in connection with deCODE's advertising or
marketing of the Other Technology or products or services relating to such Other
Technology, provided that such use has been approved in advance by the Public
Affairs Officer of the Institution whose name, trademark, logo, symbol or image
is to be so used.
4. Representations and Warranties; Disclaimer of Warranty, Liability.
4.1 Limited Warranty. deCODE hereby represents and warrants to
Institutions that, except as provided in Section 3.4, deCODE owns, and/or has
obtained sub-licensable licenses for, all proprietary rights, including
copyrights, with respect to the Other Technology.
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4.2 Obligation to Obviate Infringement. If a court of competent
jurisdiction rules, or deCODE shall otherwise decide, in its sole discretion,
that the Other Technology infringes the proprietary rights of any third party or
that deCODE otherwise has breached its representations and warranties under
Section 4.1, deCODE's sole obligation shall be, at deCODE's sole discretion:
4.2.1 To procure for Institutions, at no cost to Institutions,
the right to continue to use the Other Technology;
4.2.2 To replace or modify the Other Technology, at no cost to
Institutions, to make it non-infringing; or
4.2.3 If in deCODE's judgment the right to continue to use the
Other Technology cannot reasonably be procured or the Other Technology cannot
reasonably be replaced or modified, to terminate this Agreement pursuant to
Section 6.1.4.
4.3 Disclaimer of Liability Concerning Third Party Software.
Notwithstanding any other provision of this Agreement, deCODE shall have no
liability in the event that any Institution is unable to procure any license
with respect to the Third Party Software or in the event that any Institution
infringes, or is alleged to infringe, the proprietary rights of any third party
with respect to the Third Party Software.
4.4 Disclaimer of Warranties; Institutions' Assumption of
Responsibility. THE OTHER TECHNOLOGY IS PROVIDED FREE OF CHARGE, ON AN "AS IS"
BASIS. THEREFORE, EXCEPT AS STATED IN SECTION 4.1, DECODE MAKES NO, AND HEREBY
DISCLAIMS ALL, WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH
RESPECT TO THE OTHER TECHNOLOGY, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF
DESIGN, FREEDOM FROM DEFECTS, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE
OR ARISING FROM A COURSE OF DEALING OR USAGE OF TRADE PRACTICE. THE ENTIRE RISK
AS TO THE QUALITY OF AND PERFORMANCE OF THE OTHER TECHNOLOGY SHALL BE BORNE BY
INSTITUTIONS. EXCEPT AS PROVIDED IN SECTION 2.3 WITH RESPECT TO DE-BUGS AND
UPDATES, IF THE OTHER TECHNOLOGY PROVES DEFECTIVE IN ANY RESPECT, INSTITUTIONS,
AND NOT DECODE, SHALL BE RESPONSIBLE FOR THE ENTIRE COST OF ANY SERVICE OR
REPAIR.
4.5 No Liability. IN NO EVENT SHALL DECODE BE LIABLE TO INSTITUTIONS
FOR ANY DIRECT OR INDIRECT DAMAGES RESULTING FROM OR RELATED TO THE OTHER
TECHNOLOGY, INCLUDING, WITHOUT LIMITATION, ANY LOSS OF GOOD WILL, WORK STOPPAGE,
COMPUTER FAILURE OR MALFUNCTION, LOSS OF DATA, INFRINGEMENT AND ANY AND ALL
OTHER COMMERCIAL DAMAGES OR LOSSES, EVEN IF DECODE HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES AND REGARDLESS OF THE LEGAL OR EQUITABLE THEORY
(CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE) UPON WHICH A CLAIM FOR DAMAGES
OR RELIEF IS BASED.
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5. Confidentiality.
5.1 Generally. During the term of this Agreement and for a period of 10
years thereafter, each Party (the "Receiving Party") shall keep confidential any
and all information obtained from the other Party (the "Disclosing Party")
relating to the Other Technology (all such information obtained by both Parties,
collectively, the "Confidential Information"), and shall not disclose to any
third party or use for any purpose not contemplated by this Agreement the
Confidential Information of the Disclosing Party. Each Party shall disclose
Confidential Information of the other Party to such Party's directors, officers,
employees and agents only on a strict need-to-know basis and only if each such
person has agreed to be bound by confidentiality provisions at least as
protective of the Confidential Information of the other Party as set forth in
this Section 5. Each Institution acknowledges and agrees that the Licensed
Technology and the Documentation constitute Confidential Information of deCODE,
and deCODE acknowledges and agrees that the use of the Program by Institutions,
and any information output from such use, does not constitute disclosure of
Confidential Information of deCODE.
5.2 Exceptions. Notwithstanding Section 5.1, a Receiving Party shall
have no obligation to maintain the confidentiality of any Confidential
Information of the Disclosing Party that the Receiving Party can prove, through
contemporaneous written evidence:
5.2.1 Was in the Receiving Party's lawful possession prior to
disclosure to the Receiving Party;
5.2.2 Is later lawfully made available to the Receiving Party
by a third party having no obligation of confidentiality to the Disclosing
Party;
5.2.3 Is, or later becomes, available to the public through no
act or omission of the Receiving Party; or
5.2.4 Is shown by documentary evidence in Institutions'
possession and control to have been independently developed by personnel of
Institutions who did not have access to such Confidential Information.
6. Termination.
6.1 Termination. deCODE may terminate this Agreement upon written
notice to Institutions:
6.1.1 In the event that any Institution breaches a material
term of Section 3.2;
6.1.2 In the event that any Institution breaches a material
term of this Agreement (other than Section 3.2) and fails to cure such breach
within sixty (60) days of receipt of written notice identifying such material
breach; or
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6.1.3 In the event that deCODE terminates the Crosswalk
Development Agreement or the Strategic Alliance Agreement as a result of a
breach by any Institution, as provided in such Agreements; or
6.1.4 In the event that the Strategic Alliance Agreement is
terminated pursuant to Section 10.5 thereof following an Institution Notice
under the Strategic Alliance Agreement; or
6.1.5 In the event deCODE makes the determination described in
Section 4.2.3.
6.2 Effect of Termination.
6.2.1 Promptly after termination of this Agreement pursuant to
Section 6.1, Institutions shall return to deCODE, or destroy, at deCODE's sole
discretion, the Other Technology in any of the Institutions' possession or
control.
6.2.2 Termination of this Agreement for any reason shall be
without prejudice to any rights that shall have accrued to the benefit of either
Party prior to such termination. Such termination shall not relieve either Party
from obligations that are expressly indicated to survive termination of this
Agreement.
7. Alternative Dispute Resolution.
7.1 Negotiation. The Parties shall attempt in good faith to resolve,
through negotiation, any dispute, claim or controversy arising out of or
relating to this Agreement. Either Party may initiate negotiations by providing
written notice in letter form to the other Parties, setting forth the subject of
the dispute and the relief requested. The recipient of such notice shall respond
within five (5) days with a written statement of its position on, and
recommended solution to, the dispute. If the dispute is not resolved by this
exchange of correspondence, then representatives of each Party with full
settlement authority shall meet at a mutually agreeable time and place within
ten (10) days of the date of the initial notice in order to exchange relevant
information and perspectives, and to attempt to resolve the dispute.
7.2 Arbitration. Except with respect to breaches for which a Party is
seeking injunctive relief, all disputes between the Parties relating to this
Agreement or the subject matter hereof which cannot be resolved by the Parties
according to Section 7.1, shall be submitted for final and binding arbitration
before JAMS/Endispute ("JAMS") pursuant to the United States Arbitration Act, 9
U.S.C. Section 1 et seq., and shall be held at a mutually agreeable location or
in New York City. Either Party may commence the arbitration process pursuant to
this Agreement by filing a written demand for arbitration with JAMS, with a copy
to the other Parties. Unless the Parties otherwise agree in writing, the
arbitration shall be conducted in accordance with the provisions of JAMS
Comprehensive Arbitration Rules and Procedures in effect at the time of filing
of the demand for arbitration if the amount in controversy is greater than
$250,000, exclusive of interest; or the arbitration shall be conducted in
accordance with the provisions of JAMS Streamlined Arbitration Rules and
Procedures in effect at the time of filing of the demand for arbitration if the
amount in controversy is $250,000 or less, exclusive
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of interest. The Parties shall cooperate with JAMS and with one
another in selecting an arbitrator from JAMS' panel of neutrals, and in
scheduling the arbitration proceedings; provided however, that all arbitrators
must be knowledgeable and experienced in the biotechnology and bioinformatics
industries and, in the case of a dispute concerning the Crosswalk, the software
development industry, and must not be affiliated through employment or otherwise
with a competitor of any Party, as determined through mutual assent of the
Parties. The Parties shall participate in the arbitration in good faith, and
shall share equally in its costs. The provisions of this Section may be enforced
by any Court of competent jurisdiction, and the Party seeking enforcement shall
be entitled to an award of all costs, fees and expenses, including attorneys'
fees, to be paid by the Party against whom enforcement is ordered.
7.3 Injunctive Relief. This Section 7 shall not prohibit a Party from
seeking injunctive relief from a court of competent jurisdiction in the event of
a breach or prospective breach of this Agreement by the other Party, which would
cause irreparable harm to the first Party.
8. Miscellaneous.
8.1 Governing Law. This Agreement shall be governed by, construed, and
interpreted in accordance with the laws of the State of Delaware, without
reference to principles of conflicts of laws.
8.2 Independent Contractors. The relationship of deCODE and
Institutions established by this Agreement is that of independent contractors,
and nothing contained in this Agreement shall be construed to (a) constitute the
Parties or their employees as partners, joint venturers, co-owners or otherwise
as participants in a joint or common undertaking, or (b) allow any of the
Parties hereto to create or assume any obligation on behalf of another Party
hereto for any purpose whatsoever.
8.3 Assignment. No Party shall assign its rights or duties under this
Agreement to another without the prior express written consent of the other
Parties, which consent shall not be unreasonably withheld; provided, however,
that any Party may assign this Agreement to a successor in ownership of all or
substantially all its business assets. Such successor shall expressly assume in
writing the obligation to perform in accordance with the terms and conditions of
this Agreement.
8.4 Entire Agreement. This Agreement, the Strategic Alliance Agreement,
Sponsored Research Agreements and Clinical Trial Agreements (including any
License Agreements entered into pursuant thereto), other Software License
Agreements, and the Crosswalk Development Agreement constitute the entire and
only agreements between the parties relating to the subject matter hereof, and
all prior negotiations, representations, agreements and understandings are
superseded by these agreements.
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8.5 Notices. All notices, demands and other communications of every
kind and description whatsoever required or permitted under this Agreement shall
be in writing and shall be deemed to have been received when personally
delivered, or when shipped by private express carrier (signature required),
shipment charges prepaid, or when sent via facsimile transmission (receipt
verified) to the Party to whom delivery shall be made at the respective
addresses as set out below.
If to Partners, to: With a copy to:
Partners HealthCare System, Inc. Partners HealthCare System, Inc.
Prudential Tower, 000 Xxxxxxxx Xxxxxx Prudential Tower, 000 Xxxxxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000-0000 Xxxxxx, Xxxxxxxxxxxxx, 00000-0000
Attn: Crosswalk Coordinator Attn: Vice President, Corporate Sponsored Research and
Institution Agreement #________ Licensing
Telephone: (000) 000-0000 Telephone: (000) 000-0000
Facsimile: (000) 000-0000 Facsimile: (000) 000-0000
If to MGH, to: If to BWH, to:
Massachusetts General Hospital The Xxxxxxx and Women's Hospital, Inc.
000 00xx Xxxxxx, Xxxxx 0000 0000 Xxxxxxxx Xx., Xxxxx 000
Xxxxxxxxxxx, Xxxxxxxxxxxxx 00000 Xxxxxx, Xxxxxxxxxxxxx 00000
Attn: Director, Corporate Sponsored Research and Licensing Attn: Director, Corporate Sponsored Research and
Institution Agreement #________ Licensing
Telephone: (000) 000-0000 Institution Agreement #________
Facsimile: (000) 000-0000 Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If to deCODE, to:
deCODE genetics Ltd.
Xxxxxxxxx 0
XX-000 Xxxxxxxxx, Xxxxxxx
Attn: Crosswalk Coordinator
Telephone: x000-000-0000
Facsimile: x000-000-0000
8.6 Modification. No modification or waiver of this Agreement or of any
covenant, condition, or limitation herein contained shall be valid unless in
writing and duly executed by both Parties.
8.7 Waiver. No waiver of any rights shall be effective unless assented
to in writing by the Party to be charged and the waiver of any breach or default
shall not constitute a waiver of any other right hereunder or any subsequent
breach or default.
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8.8 Headings. The Section headings are intended for convenience of
reference only and are not intended to be a part of or to affect the meaning or
interpretation of this Agreement.
8.9 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and effect
without said provision; provided, however, that no such severability shall be
effective if the result of such action materially changes the economic benefit
of this Agreement to deCODE or to Institutions.
8.10 Construction. The Parties have participated equally in the
creation of this Agreement; the language of this Agreement shall not be
presumptively construed against either Party.
8.11. Survival. All of the parties' respective rights and obligations
under Sections 2.4, 3, 4.3, 4.4, 4.5, 5, 6.2, 8.1, 8.9, 8.10 and 8.11 shall
survive termination of this Agreement.
8.12 Counterparts. This Agreement may be executed in counterparts, each
of which shall constitute an original document, but all of which together shall
constitute one and the same agreement.
* * *
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In witness whereof, each of the Institutions and deCODE have caused
this Agreement to be executed by their duly authorized representatives as of the
date first set forth above.
PARTNERS HEALTHCARE SYSTEM, INC. deCODE GENETICS LTD.
BY: _____________________________ BY: ______________________________
NAME: __________________________ NAME: ___________________________
TITLE: __________________________ TITLE: ___________________________
DATE: __________________________ DATE: ___________________________
THE GENERAL HOSPITAL CORPORATION THE XXXXXXX AND WOMEN'S HOSPITAL,
D.B.A. MASSACHUSETTS GENERAL HOSPITAL INC.
BY: _____________________________ BY: ______________________________
NAME: __________________________ NAME: ___________________________
TITLE: __________________________ TITLE: ___________________________
DATE: __________________________ DATE: ___________________________
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APPENDIX A
PROGRAM
000
XXXXXXXX X
LICENSED TECHNOLOGY
