Research Contract - Research Team for Peripheral Artery Occlusive Disease and Islensk Erfdagreining ehf.
RESEARCH CONTRACT ON THE CO-OPERATION OF
A RESEARCH TEAM FOR PERIPHERAL ARTERY OCCLUSIVE DISEASE
AND
ISLENSK ERFDAGREINING EHF
A Research Team for Peripheral Artery Occlusive Disease, on the one hand,
hereinafter referred to as the Research Team, and, on the other hand, Islensk
erfdagreining ehf., hereinafter referred to as IE, enter into the following
A g r e e m e n t
on co-operation in the research of the inheritability of Peripheral Artery
Occlusive Disease. This Contract is made on the basis of the Co-Operation
Agreement between the Reykjavik Municipal Hospital and IE of 4 November 1998 and
the Co-Operation Agreement between State Hospitals and IE of 15 December 1998,
both of which shall prevail over this Contract in the event of discrepancy
between individual provisions of the agreements.
CHAPTER 1
THE SUBSTANCE OF THE CO-OPERATION
The Research Team and IE agree to co-operate, on the basis of this Contract, in
the search and isolation of genes involved in the genesis of Peripheral Artery
Occlusive Disease. The proposed co-operation between the parties will
hereinafter be referred to as the Research Project.
In addition, the Research Team and IE enter into a separate agreement on a
additional research into the disease aortic aneurysm. A separate protocol,
attached to this Contract in Annex D, applies to this By-Research and its
relation to the Research Project.
CHAPTER 2
CONTRIBUTIONS OF THE PARTIES TO THE RESEARCH PROJECT
2.1 RESEARCH MATERIALS AND THEIR PROCUREMENT
The Research Team shall provide biological samples (blood samples), other
clinical data and research materials which the Research Team may possess or have
access to, in relation to patients suffering from aortic aneurysm and their
relatives.
The Research Team shall supervise relations with individuals intended to
participate in the research and/or their legal guardians, e.g. calling them in
for blood tests, diagnoses, examination of participants and the procurement of
the informed consent of participants. IE, on the one hand, and the Research Team
and individuals within the Team, on the other hand, undertake to do whatever is
in their power so that the procurement of research materials pursuant to this
paragraph shall proceed with expedience and safety. In this respect, account
shall be taken of the Research Plan, which includes milestone dates and is to
attached to this Contract, as Annex A ("Research Plan and Cost Estimation for
the Research of IE and a Research Team on Peripheral Artery Occlusive
Disease"). Annex A shall specify which research
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materials are intended for use in the research and from which health-care
institutions the materials derive. All research materials delivered to the IE
research laboratory shall first be encrypted at the Genetic Research Service
Centre, a private institution domiciled at Noatun 17, Reykjavik, before being
transported to IE, in accordance with the instructions of the Data Protection
Commission.
2.2. EXPERTISE, EQUIPMENT AND RESEARCH FACILITIES
The Research Team shall provide expertise and knowledge in relation to the
diagnosis of diseases as well as the design and organisation of the Research
Project. IE and the Research Team shall provide expertise for the design and
organisation of the research. IE shall also be responsible for the research and
testing of blood samples and genetic material, the assessment of the inheritance
of the disease and the interpretation of the findings of the research. IE shall
provide equipment, research resources, laboratory reagents and personnel for
these purposes.
2.3. PAYMENT OF RESEARCH EXPENSES
IE shall cover all expenses of the Research Project necessary to achieve the
objectives of the Project, including materials and wage costs in relation to
calling in participants for research and necessary sampling. The Research Team
and IE shall jointly submit a total budget plan on signature of this Contract,
in which the projected materials and wage costs of the Project are estimated,
see Annex A. Annex A shall also further delineate the itemisation of individual
cost items and the manner in which the procurement of consent and the payment of
bills shall be conducted.
The State Hospitals and the Reykjavik Municipal Hospital may request information
on wage payments covered by IE to employees of these institutions working on the
Research project.
CHAPTER 3
RIGHTS OF THE PARTIES
3.1. RIGHTS OF HEALTH-CARE INSTITUTIONS
The parties to this Contract are aware that identical Co-Operation Agreements
(hereinafter the Institutional Agreement(s)) are in force between, on the one
hand, IE and, on the other hand, the State Hospitals and the Reykjavik Municipal
Hospital. The Institutional Agreements are annexed as supporting documents to
this Research Contract, see Annexes B (State Hospitals) and C (Reykjavik
Municipal Hospital). The provisions of the Institutional Agreements shall apply
to this Research Contract, as applicable, in relation to the part of the
research concerning the State Hospitals/the Reykjavik Municipal Hospital and
their staff.
The State Hospitals and the Reykjavik Municipal Hospital, on the one hand, and
the Research Team, on the other hand, have entered into a separate agreement,
dated 28 May 1999, on their own behalf and on behalf of AEdaskurdlaekningafelag
Islands (an Icelandic association for vascular surgery), annexed to this
Contract, see Annex E. The agreement provides for, i.a., the division, custody
and auditing of funds disbursed by IE to the Research Team and the State
Hospitals/the Reykjavik Municipal Hospital, pursuant to Chapters 3.3 and 3.4.,
cf. Chapter 3.6, of this Research Contract.
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IE and its parent company, deCODE genetics Inc. (hereinafter referred to as
deCODE) have entered into an agreement with the Swiss pharmaceutical company
Hoffman La-Roche (hereinafter referred to as the Purchaser) on the sale of the
Research Project, its findings and returns.
3.3. FIXED PAYMENTS FROM IE TO THE RESEARCH TEAM IN RELATION TO THE SALE OF THE
RESEARCH PROJECT IE shall pay the Research Team [CONFIDENTIAL TREATMENT
REQUESTED] on the effective date of this Contract. Subsequently, IE shall pay
[CONFIDENTIAL TREATMENT REQUESTED] per year, until a total of [CONFIDENTIAL
TREATMENT REQUESTED] have been paid, including the initial payment.
Payments from IE to the Research Team pursuant to this Chapter shall be paid on
the following payment dates:
[CONFIDENTIAL TREATMENT REQUESTED]
In the event that the Research Project ends within five years from the effective
date of this Contract, upon achieving the objective of the Research Project, IE
shall immediately pay the remaining amount so that a total of [CONFIDENTIAL
TREATMENT REQUESTED] shall have been paid, pursuant to this Chapter. Payments
pursuant to this Section are additional to and independent of conditional,
performance-related payments pursuant to Section 3.4.
3.4. PERFORMANCE-RELATED PAYMENTS FROM IE IN RELATION TO THE SALE OF THE
RESEARCH PROJECT
IE/deCODE have made an agreement with the Purchaser of the Project that the
Purchaser shall pay special conditional payments to IE/deCODE which shall be
totally dependent on the scientific and practical results achieved in the
performance of the Research Project. The performance-related milestones which
activate the Purchaser's obligation to pay have been further specified in the
agreement between IE/deCODE and the Purchaser. If the above-mentioned milestones
are not achieved, no payments shall be made pursuant to this Section.
IE shall pay the Research Team [CONFIDENTIAL TREATMENT REQUESTED] of the
performance-related payments from the Purchaser to IE/deCODE, pursuant to
Paragraph 1, if success is achieved. Other payments from the Purchaser to
IE/deCODE in relation to the reimbursement of IE's cash outlay for the Research
Project, as specified in the agreement between IE and the Purchaser, as well as
investment in IE or deCODE, shall be paid in full to IE/deCODE.
IE shall report to the Research Team as soon as the Purchaser has confirmed that
a milestone has been achieved which activates his obligation to pay. IE promises
to pay the Research Team its share in the performance-related payment as soon as
such payment has been received by IE/deCODE. The Research Team is authorised by
IE/deCODE to seek the confirmation of the companies' auditor, concurrently with
the quarterly statement, of whether and when a milestone payment was received
for the Research Project.
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3.5. PROVISO ON CO-OPERATION WITH RESEARCH PARTIES UNRELATED TO THE RESEARCH
TEAM
The payments pursuant to Section 3.4. are based on the assumption that
co-operation with research parties outside the Research Team and institutions
related to the Research Team will not prove necessary for the achievement of the
Research Project's objectives. If the Executive Committee of the Project finds
it necessary to begin co-operation with other parties, as defined in the
foregoing, the provisions of Sections 3.4. and 3.6. shall be reviewed on the
basis that the total payments from IE to the Research Team and institutions
related to the Research Team, on the one hand, and, on the other hand, the third
party, as specified in Section 3.4., shall remain unchanged, i.e. the third
party may acquire a claim to a part of the payments pursuant to Section 3.4.,
which would otherwise have been paid in full to the Research Team.
3.6. ARRANGEMENT OF PAYMENTS AND THE DISPOSAL OF PAYMENTS FROM IE PURSUANT TO
SECTION 3.3. AND 3.4., CF. ALSO SECTION 7.3. IN THE INSTITUTIONAL AGREEMENT
All payments from IE to the Research Team pursuant to Sections 3.3. and 3.4. of
this Contract shall be divided and paid as follows, cf. the provisions of
Section 7.3. of the Institutional Agreement as well as other provisions of the
Institutional Agreement. The following division of payments is based on an
understanding between the parties to this Contract and their evaluation of the
importance of each person's contribution to the Research Project. The following
division is also based on the agreement cited in Paragraph 2 of Section 2.1.,
see Appendix E. In accordance with the foregoing, all payments from IE pursuant
to Sections 3.3. and 3.4. shall be divided in the following proportions:
[CONFIDENTIAL TREATMENT REQUESTED]
All funds whose appropriation is in the hands of the Research Team shall be used
for scientific activity in the field of Peripheral Artery Occlusive Disease
conducted by the Scientific Fund of AEdaskurdlaekningafelag Islands. Further
arrangements for the handling of the above-mentioned monies of the Scientific
Fund, as well as the arrangement of the Fund's auditing, shall conform to the
agreement provided for in Appendix E, and is not a concern of IE
CHAPTER 4
MANAGEMENT AND LIABILITY
Decisions relating to the performance of the Research Project shall be made
jointly by the Research Team and IE. A special Executive Committee shall be
established, to which two representatives shall be appointed from each party to
this Contract to draw up rules on the arrangement, control and performance of
the Research Project. The Chief Supervisor of the Research Project shall be
elected from among the members of the Executive Committee.
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Another responsibility of the Committee is to define the objectives of the
Research Project and set forth the professional requirements which the parties
to this Contract agree to be satisfactory for the performance of the Project.
Decisions on incurring expenses in relation to the Research Project shall be
submitted in advance and confirmed by the Executive Committee. As applicable,
the Executive Committee may enter into agreements with health-care institutions
on the use of their manpower and facilities for the performance of certain work
procedures pertaining to the clinical aspect of the Research Project. In
November each year the Executive Committee shall prepare a budget for the
clinical aspect of the Research Project in the following year.
The Executive Committee shall supervise the processing of data and the
publication of conclusions in accordance with the rules of Chapter 5.
The Research Team and individuals within the Team shall not be financially
responsible to IE or parties with which IE has entered into agreements, for the
achievement of the commercial or financial objectives of the research.
In the event that a third party causes the research to be cancelled, or the
Contract is terminated for reasons for which the Research Team is not
responsible, the Research Team and parties within the Research Team shall not be
held financially responsible to IE for such a project ending. The same applies
if the research must be altered as a result of amendments to legislation or
regulations or decisions of public authorities.
IE shall cover the expense of procuring liability insurance for individuals
within the Research Team employed by the State Hospitals or the Reykjavik
Municipal Hospital when this Contract takes effect, as well as for staff working
for them. This shall apply to all work of these parties in the interest of the
Research Project.
CHAPTER 5
HANDLING, PROCESSING AND COMMUNICATION OF INFORMATION
The parties to this Contract undertake to maintain all personal information in
confidence. The parties to this Contract undertake to comply with the
instructions of the Data Protection Commission and, as applicable, the special
representative (inspector) of the Data Protection Commission on the handling and
processing of such data, as well as with the instructions and conditions of the
Science Ethics Committee, which operates pursuant to the Act on Patients'
Rights.
The findings of the Research Project shall be immediately published as soon as
they fulfil scientific requirements and are fit for publication. However, IE or
the Purchaser of the Project may have the publication of the findings postponed
for 90 days, if necessary for the procurement of patents and other rights of
ownership related to the findings of the Project. The Executive Committee of the
Project shall decide in advance who shall be Chief Supervisor of the Research
Project. Otherwise, the first cited author of scientific articles shall be Chief
Supervisor. The order of authors shall be in accordance with current rules in
the international scientific community.
The parties to this Contract promise mutual confidentiality as regards
information in relation to the substance of this Contract, business plans, the
progress of the Project
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and its conclusions. Information of this kind may not be communicated to an
outside party without the consent of both parties.
CHAPTER 6
LIMITATION ON CO-OPERATION WITH OTHER PARTIES
The Research Team promise to work neither jointly nor separately with other
parties on research into the inheritability of Peripheral Artery Occlusive
Disease during the Research Project. In the event that the Research Project
leads to a discovery of financial significance for IE, the Research Team and
individual parties within the Team promise not to co-operate with other parties
on the part of the Research Project which led to the discovery for five years
immediately following the conclusion of the Project pursuant to this Contract.
On the other hand, if the Research Project does not lead to a discovery,
individual parties within the co-operating team have the right to enter into
co-operation with other parties on the research into the inheritability of
Peripheral Artery Occlusive Disease after the Research Project has ended.
IE promises not to begin collaboration with other parties in the research of the
inheritability of Peripheral Artery Occlusive Disease during the Research
Project, unless the Executive Committee considers such collaboration necessary
to achieve the objective of the Research Project. In the event that the addition
of new co-operative parties to the Research Project is considered necessary, the
Executive Committee shall be in charge of the selection of such a party. In the
event of a dispute within the Executive Committee, the Research Team shall
decide on what basis to select additional co-operative parties. The provisions
of this Paragraph shall, however, not prevent IE from collaborating in the field
of the Research Project with parties that have negotiated the purchase of the
Research Project, its conclusions or returns, on the condition that such actions
do not reduce the right to payments pursuant to Chapter 3.
CHAPTER 7
DURATION OF CONTRACT AND PROJECT COMPLETION
The effective date of this Contract shall be the date (hereinafter the date of
this Contract) on which this Contract has both been signed by the parties to
this Contract and confirmed by the State Hospitals and the Reykjavik Municipal
Hospital, in accordance with Paragraph 2 of Chapter 2 of the Institutional
Agreement.
The Research Project shall have a duration of five years immediately following
this Contract's effective date, unless the Project is concluded earlier in the
view of the Executive Committee. If either party has materially defaulted on the
Contract, the other party may terminate the Contract. In the event of a dispute
on the right of the parties to terminate the Contract, the settlement procedures
regarding such dispute shall be pursuant to Chapter 8.
The return of original data of the State Hospitals/the Reykjavik Municipal
Hospital shall be pursuant to Paragraph 5 of Chapter 6 of the Institutional
Agreements.
In the event that either or both parties are interested in continuing the
co-operation after the Research Project has ended, an agreement shall be made to
this effect.
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Despite a conclusion of the research pursuant to this Contract, whether owing to
the completion of the Project or termination or breach of the Contract, the
obligation of IE/deCODE to cover payments pursuant to Section 3.4. shall remain
in force until IE/deCODE's right of payments from the Purchaser is cancelled at
any time, e.g. when a patent expires.
CHAPTER 8
SETTLEMENT OF DISPUTES
In the event of a dispute between the parties to this Contract regarding
performance or compliance that cannot be resolved by the Executive Committee,
two persons, one from each party, shall endeavour to reach an agreement on its
settlement. If a settlement is not reached between those two persons within two
weeks of the submission of the dispute, each party to the Contract shall appoint
one arbitrator and then jointly request the appointment of an impartial third
arbitrator by the District Court of Reykjavik to assist in the resolution of the
dispute, thus forming a tribunal of three arbitrators. The arbitration tribunal
shall reach a decision in the matter within 3 months from the appointment of the
third arbitrator.
The cost of the work of the tribunal shall be determined by the tribunal at each
time. The work, procedure and rulings of the arbitration tribunal shall
otherwise be governed, as appropriate at any time, by Act No. 53/1989 on
Contractual Arbitration.
Notwithstanding the above provisions on arbitration, cases involving the
collection of payments under this Contract which are not in dispute between the
parties may be submitted to the public courts. The same applies to cases of
financial claims made by one party against the other, based on rulings of the
arbitration tribunal regarding non-performance or breach by the latter of this
Contract. Such cases shall be submitted to the District Court of Reykjavik.
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This Contract, which comprises 8 chapters on 8 pages, in addition to appendices
A, B, C, D and E, is made in two identical copies, one copy to be held by the
parties to the Contract.
Reykjavik, 28 May 1999.
On behalf of the Research Team On behalf of Islensk Erfdagreining ehf.
for Peripheral Artery Occlusive
Disease
Stefan E. Matthiasson [sign.] Kari Stefansson [sign.]
Reykjavik Municipal Hospital President
Halldor Johannsson [sign.] Kristjan Erlendsson [sign.]
The State Hospitals Executive Director of IE Co-operative
Projects
Confirmed on behalf of
the Reykjavik Municipal
Hospital
Reykjavik
___________________________
Magnus Petursson [sign.] Certified that the above
is a faithful English
translation of a signed
Confirmed on behalf of Icelandic document.
the State Hospitals ___________________________
Reykjavik
Magnus Petursson [sign.]
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