Research Contract - Research Team for Cerebral Haemorrhage and Islensk Erfdagreining ehf.
RESEARCH CONTRACT ON THE CO-OPERATION OF
A RESEARCH TEAM FOR CEREBRAL HAEMORRHAGE
AND
ISLENSK ERFDAGREINING EHF
A research team for cerebral haemorrhage, 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
Contract
on co-operation on the research of the inheritability of cerebral haemorrhage.
This Contract is made on the basis of the Co-operation Agreement between the
Reykjavik Municipal Hospital and IE from 4 November 1998 and the Co-operation
Agreement between the State Hospitals and IE from 15 December 1998, the two of
which shall prevail over this Contract in case of any discrepancy between their
individual provisions.
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 cerebral
haemorrhage. The co-operation between the parties will hereinafter be referred
to as 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 biosamples (blood samples), other clinical data
and research materials which the Research Team may already possess or have
access to, in relation to patients suffering from cerebral haemorrhage and their
relatives. These materials derive from the National Association for the
Prevention of Heart Diseases, Hjartavernd, (hereinafter referred to as NAPHDH),
the State Hospitals (hereinafter referred to as SH) and the Reykjavik Municipal
Hospital (hereinafter referred to as RMH). The Research Team and IE agree that
expertise and other contributions from the above institutions are equally
important in terms of quality and significance for the Research Project.
The Research Team shall supervise relations with individuals intended to
participate in the research and/or their legal guardians, including calling in
participants for blood testing, 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 attached to this Contract as Annex A ("Research Plan and Cost
Estimation for the Research of IE and the Research Team on Cerebral
Haemorrhage"). Annex A shall specify which research materials are
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intended for use in the research and from which health-care institutions these
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, necessary sampling and the procurement of
clinical materials. The Research Team and IE shall jointly submit a
comprehensive budget 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. In the event of direct cash outlay on the part of SH/RMH in relation
to the conduct of this Research Project, IE and SH/RMH shall make a special
agreement on the payment of such cost, cf. the Institutions Agreement.
SH and RMH may request information from IE on wages paid by IE to individual
employees of these institutions working on the Research Project.
2.4. ASSISTANCE WITH THE PROCUREMENT OF A PATENT
The Research Team and individuals within the Team undertake to provide IE with
the assistance necessary to enable IE to ensure international patent protection
of the findings of the Research Project, by signing applications for patents
together with IE when necessary, provided that IE pays all expenses in relation
to patent protection.
CHAPTER 3
RIGHTS OF THE PARTIES
3.1. THE RIGHTS OF HEALTH-CARE INSTITUTIONS
The parties to this Contract are aware that a framework agreement on
co-operation between NAPHDH and IE on research on the inheritability of certain
diseased is currently in effect. The provisions of the framework agreement
between NAPHDH and IE are valid for the part of the Research Project involving
NAPHDH. The parties to this Contract are also aware that identical co-operation
agreements between, IE, on the one hand, and SH and RMH, on the other hand,
(hereinafter referred to as the Institutions Agreement(s)) are currently in
effect. The Institutions Agreements are attached to this Research Contract as
Annex B (SH) and C (RMH). The provisions of
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the Institutions Agreements shall be valid for this Research Agreement, where
applicable, as regards the part of the research involving SH/RMH and their
staff.
3.2. FINANCIAL AND COMMERCIAL RIGHTS ATTACHED TO THE FINDINGS OF THE RESEARCH
PROJECT
IE shall be sole owner of all financial and commercial rights attached to the
Research Project and its results. IE shall have the right to sell the results
and findings of the Research Project to a third party and utilise it financially
in any other way consistent with approved ethical standards, irrespective of
whether this takes place before or after the completion of the Research Project.
deCODE shall never be considered the purchaser of the Project in the
understanding of this Contract.
IE and its parent company, deCODE genetics Inc. (herinafter referred to as
deCODE) have made a contract with the Swiss pharmaceutical company Hoffman
La-Roche (hereinafter referred to as the Purchaser) on the sale of the Research
Project, its results and findings.
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. Also, IE shall pay [CONFIDENTIAL TREATMENT
REQUESTED] on 1 July 1999, the same amount on 15 March 2000 and annually
thereafter until a total of [CONFIDENTIAL TREATMENT REQUESTED] have been paid
including the initial payment.
Thus, payments from IE to the Research Team under this chapter shall take place
on the following payment dates:
[CONFIDENTIAL TREATMENT REQUESTED]
In the event that the Research Project ends before 15 March 2002, upon achieving
its objective, IE shall pay the remaining amount so that a total of
[CONFIDENTIAL TREATMENT REQUESTED] shall have been paid pursuant to this
chapter. Payments pursuant to this chapter are additional and independent to
conditional, performance-related payments under Chapter 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 to the effect
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 contract between IE/deCODE and the Purchaser. In the event that the above
milestones are not achieved, no payments pursuant to this chapter shall be made.
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IE will 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 repayment of the cash outlay of IE for the Research
Project, as defined in the contract between IE and the Purchaser, and the
Purchaser's 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 which activates the Purchaser's obligation to pay has been achieved.
IE promises to pay the share of the Research Team in the performance-related
payment as soon as such payment has been delivered to IE/deCODE. The Research
Team may appoint a special auditor who has access to the accounts of IE/deCODE
regarding milestone payments concurrently with the quarterly statement of the
companies, in order to seek confirmation whether and when a milestone payment
was obtained for the Research Project as well as of the amount of that payment.
3.5. PROVISO ON CO-OPERATION WITH RESEARCH PARTIES UNRELATED TO THE RESEARCH
TEAM
The Research Team's right of receiving payments pursuant to Chapters 3.3 and 3.4
is based on the assumption that IE will not pay other parties than the Research
Team and its related institutions which employ individual parties within the
Research Team for contribution to the Research Project and expertise to which it
is necessary to gain access for the achievement of the objectives of the
Research Project in the view of the Executive Committee of the Project. If the
Executive Committee is of the opinion that it is necessary to enter into
co-operation with other parties pursuant to the above, the provisions of
Chapters 3.3. and 3.4. shall be reviewed on the basis that the total payments
from IE to the Research Team and/or institutions related to them, on the one
hand, and a third party, on the other hand, shall remain unchanged from the
payments described in Chapters 3.3 and 3.4.
3.6. THE ARRANGEMENT OF PAYMENTS FROM IE AND THE INTERNAL DIVISION OF PAYMENTS
BETWEEN PARTIES WITHIN THE RESEARCH TEAM
All payments from IE to the Research Team pursuant to Chapter 3.3. and 3.4. of
this Contract shall be divided and paid as follows, cf. the provisions of
Chapter 7.3. of the Institutions Agreement and the provisions of the
Institutions Agreement in other respects, cf. also the framework agreement
between IE and NAPHDH. The following division of payments is based on an
agreement between the parties to this Contract and their evaluation of the
importance of each party's contribution to the Research Project. According to
the above, the division of payments shall be proportioned as follows:
[CONFIDENTIAL TREATMENT REQUESTED]
The above division of payments shall not be binding for IE until such time as
all health-care institutions which contribute materials for the research have
confirmed this Contract in signature, cf. Paragraph 2 of Chapter 2 of the
Institutions Agreement as regards SH and RMH. The institutions in question shall
invoice IE for payments
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pursuant to Chapter 3.3. which shall be paid in accordance with the provisions
of the Institutions Agreements which have been made between IE/deCODE, on the
one hand, and SH/RMH, on the other hand. The same rules shall apply in relation
to payments to NAPHDH.
The following paragraph only applies to the allocation of funds raised by
parties within the Research Team who are employed by SH/RMH when this Contract
is made.
All funds raised by SH/RMH staff within the Research Team pursuant to the
provisions of Chapters 3.3. and 3.4. of this Contract the application of which
is governed by such staff pursuant to the Institutions Agreement and further
agreement with the institution in question shall be utilised for the research of
cerebral haemorrhage and other nervous diseases. Further arrangement of the
custody and application of the above funds within the scope of the Institutions
Agreement shall be pursuant to a further agreement between the institution and
staff in question and is of no consequence to IE. All funds raised by SH/RMH
staff pursuant to the above shall be preserved in a research fund. The
accounting and financial matters of the fund shall be supervised by SH/RMH each
of which shall have one member on the board of directors of the fund.
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, which shall be composed of an equal number of members from each
party to this Contract, to draw up rules on the arrangement, surveillance and
performance of the Research Project. The Chief Supervisor of the Research
Project shall be elected from among the members of the Executive Committee.
It shall also be the responsibility of this Committee 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
Research Project.
Decisions on incurring expenses in relation to the Research Project shall be
submitted in advance and confirmed by the Executive Committee. When applicable,
the Executive Committee may enter into agreements with health-care institutions
on the use of the their manpower and facilities for performing individual tasks
in relation to the clinical part of the Research Project. In November each year
the Executive Committee shall prepare a budget for the clinical part of the
Research Project in the following calendar 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 an agreement as
regards the achievement of the scientific, commercial or financial objectives of
the research.
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In the event that a third party causes a cancellation of the research or the
Contract is terminated for reasons for which the Research Team is not
responsible, the Research Team and individual parties within the Team shall not
be financially responsible to IE for such cancellation of the project. The same
applies if the research or research plan needs to be altered owing to legal
amendments, regulations or the decisions of public authorities.
IE shall pay the cost of procuring liability insurance for individuals within
the Research Team who are employed by SH/RMH when this Contract takes effect as
well as the Research Team staff. This applies to all work undertaken by 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.
When individual participants are elected for participation in two or more
research projects undertaken by IE, original research materials (i.e.
biosamples) may be used for the benefit of all projects, on the condition that
the permits of the Data Protection Commission and the Science Ethics Committee
have been obtained for such shared use.
The approval of the Executive Committee is a prerequisite, in addition to the
permits of the Data Protection Commission and the Science Ethics Committee, if
the original research materials are to be used in their entirety or to a
considerable extent in other research projects of IE, e.g. if the material of
two or more research projects is merged into a new research.
The results 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 results postponed
for 90 days, if necessary to ensure patents and other rights of ownership
related to the findings of the Project. However, an effort shall be made at all
times to preserve the value of the findings by way of other measures than a
postponement of publication for 90 days.
The Executive Committee of the Research Project shall decide in advance who
shall be Chief Supervisor of the Project. As a rule, 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 and its conclusions. Information of this kind may not be
communicated to an outside party without the consent of both parties.
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CHAPTER 6
LIMITATION ON CO-OPERATION WITH OTHER PARTIES
The Research Team and individuals within the Team promise to work neither
jointly nor separately with other parties on research into the inheritability of
cerebral haemorrhage during the Research Project. In the event that the Research
Project leads to a discovery which has financial significance for IE, the
Research Team and individual parties within the Team promise not to enter into
co-operation with other parties on the part of the Research Project which led to
the discovery for four years and six months 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, the Team and individual parties within it
have the right to enter into co-operation with other parties on research into
the inheritability of cerebral haemorrhage after the Research Project has ended.
IE promises not to begin collaboration with other parties in the research of the
inheritability of cerebral haemorrhage 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-operating 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 have
the final decision on the selection of additional co-operating parties. The
provisions of this Paragraph shall not, however, 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 findings, provided that
such actions do not reduce the right to payments pursuant to Chapter 3.
CHAPTER 7
TERM OF THE CONTRACT AND PROJECT COMPLETION
The effective date of this Contract shall be the date (referred to herein as the
effective date) on which this Contract has been both signed by the parties to
the Contract and confirmed by SH and RMH in accordance with Paragraph 2 of
Chapter 2 of the Institutions Agreement, in addition to NAPHDH.
The Research Project shall have a duration of five years and six months
immediately following 15 March 1998, unless completed before such time. Pursuant
to the above, the termination of the project shall be 15 September 2003. 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 materials from SH/RMH/NAPHDH on completion of the
Research Project shall be pursuant to Paragraph 5 of Chapter 6 of the
Institutions Agreement or comparable provisions of the framework agreement
between IE and NAPHDH.
In the event that either or both parties see reason to continue the co-operation
after the completion of the Research Project, an agreement shall be made to this
effect.
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Notwithstanding the cessation of the research pursuant to this Contract, whether
as a result of the completion, cancellation or termination of the Project, the
obligation of IE/deCODE to effect payments pursuant to Chapter 3.4. shall remain
intact until the right of IE /deCODE to payments from the Purchaser is cancelled
each 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 one 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.
TEMPORARY PROVISION
This Contract shall not take effect until it has been confirmed in signature by
SH and RMH, in accordance with the provisions of Paragraph 2 of Chapter 2 of the
Institutions Agreement, in addition to NAPHDH.
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This Contract, which comprises 8 chapters on 9 pages, in addition to appendices
A-D, is made in two identical copies, one copy to be held by each of the parties
to the Contract.
Reykjavik, 3 November 1999.
On behalf of the Research On behalf of Islensk Erfdagreining ehf.
Team for Cerebral Haemorrhage
<TABLE>
<CAPTION>
<S> <C>
Einar Mar Valdimarsson [sign.] Kari Stefansson [sign.]
Physician, RMH CEO, IE
Finnbogi Jakobsson [sign.] Kristjan Erlendsson [sign.]
Physician, RMH VP for Clinical and Academic Collaborations
Gisli Einarsson [sign.]
Physician, SH
Gudmundur Porgeirsson [sign.]
Physician NAPHDH
Sigurlaug Sveinbjornsdottir [sign.] Approved on behalf of the National
Physician, SH Association for the Prevention of Heart
Diseases, Hjartavernd
Uggi Agnarsson [sign.] Reykjavik, 4/11/99
Physician, NAPHDH
Gunnar Sigurdsson [sign.]
Vilmundur Gudnason [sign.]
Physician, NAPHDH Approved on behalf of SH
--------------------------------- Reykjavik,
Certified that the above is a Magnus Petursson [sign.]
faithful English translation of
a signed Icelandic document
---------------------------------
Approved on behalf of RMH
Reykjavik,
Magnus Petursson [sign.]
</TABLE>
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