Collaboration Agreement - The Research Group on Osteoporosis and Islensk Erfdagreining ehf.
COLLABORATION AGREEMENT
BETWEEN
THE RESEARCH GROUP ON OSTEOPOROSIS
AND ISLENSK ERFDAGREINING EHF.
The Research Group on ostoeporosis (hereinafter "RO,") and Islensk erfdagreining
ehf. (hereinafter "IE") hereby enter into the following
Agreement
on research into the heredity of osteoporosis and related disorders.
I. SUBJECT OF THE COLLABORATION
RO and IE agree to work together on searching for genetic factors contributing
to osteoporosis and related disorders. The proposed collaboration of the parties
is hereinafter referred to as the "Research Project".
II. CONTRIBUTION OF THE PARTIES
RO will supply the Research Project with biological samples (blood samples),
other clinical information and research data which RO possesses or has access to
regarding patients afflicted with osteoporosis and related disorders and their
relatives which are not afflicted with osteoporosis or related disorders.
RO will be in charge of relations with the individuals intended for
participation in the research, or their legal guardians, including calling them
in for blood samples and obtaining the informed consent of the participants.
Furthermore, RO will contribute its specialised knowledge and expertise
regarding diagnosis of disorders, experimental design, conduct of experiments
and interpretation of their results.
IE will contribute its expertise in experimental design, conduct of experiments,
assessment of the heredity of the disorder and interpretation of the results of
research.
IE will also contribute equipment, research supplies, reagents and staff to
conduct experiments. IE will pay all reasonable costs of the Research Project,
including the material and wage costs of calling in participants for examination
and samples. RO will submit a financial plan assessing the projected material
and wage costs of the Project when there is sufficient information to assess its
scope.
III. RIGHTS OF THE PARTIES
IE will own all financial and commercial rights to the Research Project and its
conclusions. IE will have the right to sell to a third party the conclusions of
the Research Project or its results and to utilise the Research Project
financially in any other manner consistent with recognised ethical standards,
before or after the Research Project is concluded.
IE and its parent company, deCODE genetics Inc., has contracted with a third
party on the sale of the Research Project, its possible conclusions and results.
The amount of the payment of such third party to IE and deCODE genetics Inc.
will depend on the success of the Research Project. RO will receive as its share
[CONFIDENTIAL TREATMENT REQUESTED] of all payments by the third party to IE or
to deCODE genetics Inc., as applicable, during the term of
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such contract with the third party less the deduction of the financing by the
third party of the research costs and investment in IE or deCODE genetics Inc.
IE will pay to RO [CONFIDENTIAL TREATMENT REQUESTED] on signature of this
Agreement, and thereafter an annual amount of [CONFIDENTIAL TREATMENT REQUESTED]
during the course of the Research Project, the total amount never to exceed
[CONFIDENTIAL TREATMENT REQUESTED]. In the event that the Research Project is
concluded in a shorter time than five years by achieving the objective of the
Research Project, RO will be paid on such conclusion the amount which remains
unpaid of the [CONFIDENTIAL TREATMENT REQUESTED] pursuant to this Paragraph.
Payments pursuant to this Paragraph shall be used to finance research on
osteoporosis and related disorders. Payments pursuant to this Paragraph are in
addition to and independent of the [CONFIDENTIAL TREATMENT REQUESTED] payment
pursuant to Paragraph 2 of this Chapter III. IE is granted full authorisation by
all the individuals engaged in RO to deliver to the party accepting the initial
payment of IE to RO on behalf of RO any payments which may be subsequently
payable by IE pursuant to the terms of this Agreement. All payments pursuant to
Paragraphs 2 and 3 shall be made to the Research laboratory on bone fracture and
osteoporosis at the Reykjavik Municipal Hospital.
The right of RO to payments pursuant to Paragraphs 2 and 3 of this Chapter III
is based on the understanding that IE will not need to pay other parties for the
data and information which RO has undertaken to supply pursuant to Paragraph 1
of Chapter II, and that it will not be necessary for IE to enter into further
collaboration with other parties in Iceland regarding the study of osteoporosis
and related disorders in order to achieve the objectives of the Research
Project. In the event that it proves necessary for IE to negotiate payments to a
third party in order to ensure access to the data and information referred to in
Paragraph 1 of Chapter II, or if it proves necessary for IE to take up
collaboration with other parties in Iceland to achieve the objectives of the
research, then the provisions of Paragraphs 2 and 3 of this Chapter III shall be
reviewed so that the total payments of IE to RO and the third party remain the
same as the payments specified in Paragraphs 2 and 3.
IV. MANAGEMENT
Decisions regarding the Research Project will be taken by RO and IE jointly, and
a Steering Committee will be formed composed of two representatives from each
party to this Agreement in order to formulate rules on the arrangement, control
and implementation of the Research Project. The Co-ordinator of the Research
Project shall be selected from among the members of the Steering Committee.
The Steering Committee is also responsible for defining the objectives of the
Research Project and establishing the professional requirements which the
parties to this Agreement approve as appropriate to the conduct of the research.
The Steering Committee is responsible for the processing of data and publication
of results pursuant to the rules of Chapter V hereof.
V. HANDLING PROCESSING AND DISSEMINATION OF INFORMATION
The parties to this Agreement undertake to treat all personal information as
confidential. The parties to this Agreement undertake to observe the guidelines
of the Data Protection Commission and, as applicable, the specially appointed
representative (observer) of the Data Protection Commission regarding the
handling and processing
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of such information as well as the guidelines and conditions of the Science
Ethics Committee, which is constituted pursuant to Act No. 74/1997 on Patients'
Rights.
The results of the Research Project will be published as soon as they fulfil
academic requirements and are fit for publication. However, IE may postpone such
publication by a maximum of 90 days to secure property rights relating to any
invention arising out of the research. In the event that a third party submits
to IE a request for postponement of the publication of results when they are
ready for publication pursuant to the above, the publication may be delayed for
a maximum of 90 days.
VI. LIMITATIONS ON COLLABORATION WITH OTHER PARTIES
RO and individuals within the group covenant not to work, jointly or separately,
with others on research into the heredity of osteoporosis and related disorders
during the course of the Research Project. RO and individuals within the group
covenant not to enter into collaboration with other parties on the part of the
Research Project which led to a discovery for five years following the
conclusion of the Research Project pursuant to this Agreement. However, if the
Research Project does not lead to a discovery, individual parties within RO are
entitled to take up collaboration with other parties regarding research into the
heredity of osteoporosis and related disorders following the conclusion of the
Research Project.
IE covenants that during the course of the Research Project, IE will not take up
collaboration with other parties on research into the heredity of osteoporosis
and related disorders unless the Steering Committee regards such collaboration
as necessary in order to achieve the objectives of the Research Project. In the
event that it should prove necessary to add new partners to the Research
Project, the Steering Committee shall decide on the choice of such partner. In
the event of a dispute within the Steering Committee, RO will decide on the
choice of additional partners. Notwithstanding the above, the provisions of this
Paragraph shall not preclude collaboration by IE in the area of the Research
Project with the parties who have negotiated the purchase of the Research
Project, its conclusions or results, provided that such collaboration does not
prejudice the rights of the research group pursuant to Paragraphs 2 and 3 of
Chapter III.
VII. TERM AND CONCLUSION OF PROJECT
The Research Project shall continue for a term of five years following the
signature of this Agreement unless the Project is concluded earlier. In the
event of substantial default by either party to this Agreement the other party
may terminate this Agreement. In the event of a dispute regarding the
termination rights of a party, such dispute shall be resolved pursuant to the
terms of Chapter VIII.
At the conclusion of the Project, all clinical data (blood samples and clinical
information) shall be returned to RO.
In the event that one or both parties see reason to continue their collaboration
following the agreed term, such continuation shall be considered independently.
VIII. SETTLEMENT OF DISPUTES
In the event of a dispute between the parties regarding the implementation of
this Agreement or performance which cannot be resolved within the Steering
Committee,
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two parties, one from each party to this Agreement, shall attempt to reach a
consensus on settlement of the dispute. In the event that no settlement can be
reached by these two parties within two weeks from the time that the dispute was
submitted to them, each party to this Agreement shall appoint one arbitrator and
the parties to this Agreement shall then jointly request the appointment of a
neutral third arbitrator by the District Court of Reykjavik to participate in
the resolution of the dispute, and the three parties shall constitute an
arbitration tribunal. The tribunal shall conclude their resolution of the
dispute within one month from the time that the tribunal is fully constituted.
The cost of the work of the arbitration tribunal shall be subject to the
decision of the tribunal at each time. The work of the tribunal, procedure and
conclusions before the tribunal shall in other respects be governed,, as
applicable, by Act No. 53/1989 on Contractual Arbitration.
Notwithstanding the above provisions on arbitration, issues involving the
collection of payments under this Agreement which are not in dispute between the
parties to this Agreement may be submitted to the courts, as well as any
disputes regarding financial claims which either party may make against the
other party on the basis of the decision of the arbitration tribunal regarding
the default or breach by the other party to this Agreement. Such issues shall be
submitted to the District Court of Reykjavik.
IX. RESERVATION REGARDING THE CONCLUSION OF A FRAMEWORK AGREEMENT BETWEEN
THE REYKJAVIK MUNICIPAL HOSPITAL AND IE
This Agreement is concluded subject to the existence of a valid framework
agreement on collaboration between the Reykjavik Municipal Hospital and IE and
that this Agreement between RO and IE is confirmed by the Reykjavik Municipal
Hospital.
This Agreement is in 9 chapters on four pages. It is done in two copies, one to
be held by each party to this Agreement.
Reykjavik 19 July 1998
For the Research Group on Osteoporosis: For Islensk erfdagreining ehf.
Gunnar Sigurdsson, Head Physician [sign.] Kari Stefansson, Managing Director
[sign.]
Isleifur Olafsson, Head Physician [sign.]
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