Research Contract - Research Team for Allergy and Asthma and Islensk Erfdagreining ehf.
RESEARCH CONTRACT ON THE CO-OPERATION OF
A RESEARCH TEAM FOR ALLERGY AND ASTHMA
AND
ISLENSK ERFDAGREINING EHF
A research team for allergy and asthma, on the one hand, hereinafter referred to
as RTAA, 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 allergy and asthma.
This Contract is made on the basis of the Co-operation Agreement between the
State Hospitals and Islensk erfdagreining [e]hf. from 15 December 1998, which
shall prevail over this Contract in case of any discrepancy between their
individual provisions.
CHAPTER 1
THE SUBSTANCE OF THE CO-OPERATION
RTAA and IE agree to co-operate, on the basis of this Contract, in the search
for genes involved in the genesis of allergy and asthma. The proposed
co-operation between the parties will hereinafter be referred to as the Research
Project.
The part of the co-operation involving RTAA shall be supervised by the senior
physicians David Gislason and Porarinn Gislason and specialist Unnur Steina
Bjornsdottir.
CHAPTER 2
CONTRIBUTIONS OF THE PARTIES TO THE RESEARCH PROJECT
2.1 RESEARCH MATERIALS AND THEIR PROCUREMENT
RTAA shall provide biosamples (including blood samples and tissue samples),
other clinical data and research materials which RTAA may provide, by the permit
of the Data Protection Commission for the research, in relation to patients
suffering from allergy and/or asthma and their relatives who do not suffer from
allergy and/or asthma, cf. Article 5 of this Contract for further details.
The research population shall comprise patients who have been diagnosed as
allergic or asthmatic at the clinics of the physicians David Gislason and Unnur
Steina Bjornsdottir, in addition to patients suffering from the same diseases
who have been treated at the out-patient ward of the National Hospitals' Lung
Clinic.
RTAA shall supervise relations with individuals invited to participate in the
research and/or their legal guardians. This includes procuring the informed
consent of participants, information on health, blood tests or other sampling
and examination of disease symptoms (e.g. further diagnosis). RTAA, on the one
hand, 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 sub-chapter shall proceed with
1
<PAGE> 3
expedience and safety. In this respect, account shall be taken of the Research
Plan, which includes milestone dates and will be attached to this Contract as
Annex A (`Research Plan and Cost Estimation for the Research of IE and RTAA on
Allergy and Asthma'). 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
RTAA shall provide expertise and knowledge in relation to the diagnosis of
diseases, the design and organisation of the Research Project, the conduct of
experiments and the interpretation of their results.
IE and RTAA 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. RTAA and IE shall
jointly submit a special 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 the State
Hospitals in relation to the conduct of this Research Project, IE and the State
Hospitals shall make a special agreement on the payment of such cost, cf. the
Co-operation Agreement between the Hospitals and Islensk erfdagreining ehf.
The State Hospitals may request information from IE on wages paid by IE to
individual employees of the State Hospitals working on the Research Project.
2.4. INTELLECTUAL PROPERTY PROTECTION
RTAA and individuals within the team undertake to provide IE with the assistance
necessary to enable IE to ensure international intellectual property protection
of the findings of the Research Project, including application for patents
together with IE when necessary, provided that IE pays all expenses in relation
to intellectual property protection.
CHAPTER 3
RIGHTS OF THE PARTIES
3.1. THE RIGHTS OF HEALTH-CARE INSTITUTIONS AND THE EFFECTIVE DATE OF THIS
CONTRACT
The parties to this Contract are aware that a co-operation agreement
(hereinafter referred to as the Institutions Agreement) between IE and the State
Hospitals (hereinafter referred to as SH) is currently in effect. This agreement
is attached to this Contract as Annex B. The provisions of the Institutions
Agreement shall be valid for
2
<PAGE> 4
this Research Agreement, where applicable. All other payments from IE to RTAA
pursuant to chapters 3.3. and 3.4. of this Contract shall be in accordance with
the provisions of Chapter 7.3 of the Institutions Agreement.
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 the Research
Project 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.
3.3. FIXED PAYMENTS FROM IE AFTER THE SALE OF THE RESEARCH PROJECT TO A THIRD
PARTY On the effective date of this Contract, IE shall pay RTAA/SH
[CONFIDENTIAL TREATMENT REQUESTED].
In the event that IE or its parent company, deCODE genetics Inc. (hereinafter
referred to as deCODE), makes a contract with a third party (hereinafter
referred to as the Purchaser) on the sale of the Project, its results or
findings, IE shall pay RTAA/SH [CONFIDENTIAL TREATMENT REQUESTED] immediately
following the signature of such a contract, i.e. on the sale date of the Project
(hereinafter referred to as the date of the sale) and an annual payment of
[CONFIDENTIAL TREATMENT REQUESTED] thereafter until a total of [CONFIDENTIAL
TREATMENT REQUESTED] have been paid including the initial payment.
Thus, payments from IE under this chapter shall take place on the following
payment dates: [CONFIDENTIAL TREATMENT REQUESTED]
In the event that the Research Project ends within five years after IE/deCODE
enters into a contract with a purchaser, upon achieving the objective of the
Research Project, IE shall pay the remaining amount so that a total of
[CONFIDENTIAL TREATMENT REQUESTED] shall have been paid, pursuant to Paragraph 2
of this sub-chapter. Payments pursuant to this chapter are additional and
independent to conditional payments under Chapter 3.4.
In the event that IE/deCODE enters into more than one contract of sale on the
results of the Research Project, IE and RTAA shall negotiate specially on
possible fixed payments from IE to RTAA/SH in response to such an additional
contract or contracts, in addition to payments paid to RTAA pursuant to
Paragraphs 2-3 of this sub-chapter after IE enters into the first contract of
sale with a third party. Such payments shall be based on the net proceeds of
IE/deCODE from the latter sale of research results, the contribution of RTAA and
whether the sale is a total sale of rights attached to the Research Project or
only a partial sale of such rights. Payments under
3
<PAGE> 5
this paragraph shall, however, never exceed the total amount of the payments
specified in Paragraph 2 of this sub-chapter.
3.4. PERFORMANCE-RELATED PAYMENTS FROM IE AFTER THE SALE OF THE RESEARCH PROJECT
TO A PURCHASER If IE/deCODE manage to make a contract on the sale of the
Project, cf. Chapter 3.3, IE/deCODE shall negotiate an agreement to the effect
that the Purchaser shall pay special conditional payments to IE/deCODE which
shall be totally dependent on the scientific and/or practical results achieved
in the performance of the Project. The definitions of performance-related
milestones which activate the Purchaser's obligation to pay will be 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 paragraph
shall be made.
IE shall pay RTAA [CONFIDENTIAL TREATMENT REQUESTED] of the performance-related
payments from the Purchaser to IE pursuant to Paragraph 1 of this sub-chapter.
All other payments from the Purchaser to IE 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 RTAA as soon as the Purchaser has confirmed that a milestone
which activates the Purchaser's obligation to pay has been achieved. The share
of RTAA in the milestone-related payment shall be paid when the milestone
payment from the Purchaser has been delivered to IE/deCODE. RTAA 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 has been
achieved in relation to the Research Project.
Performance-related payments from IE to RTAA under this sub-chapter shall be
calculated from the performance-related payments from the third party to
IE/deCODE as regards contracts of sale which IE/deCODE may enter into on the
results of the Research Project.
3.5. ARRANGEMENT OF PAYMENTS AND DISPOSAL OF PAYMENTS FROM IE PURSUANT TO
CHAPTERS 3.3 AND 3.4., CF. ALSO CHAPTER 7.3 OF THE INSTITUTIONS AGREEMENT
All payments from IE to RTAA/SH pursuant to Chapters 3.3. and 3.4. shall be paid
into a special fund in the custody of SH, cf. Paragraph 2 of Chapter 7.3. of the
Institutions Agreement, cf. also the provisions of that Agreement in other
respects.
All funds raised by RTCOPD pursuant to the provisions of Chapters 3.3. and 3.4.
of this Contract the application of which will be governed by RTCOPD under the
Institutions Agreement and further agreement between RTCOPD and SH, shall be
allocated by RTCOPD to the research of allergy and asthma. Such moneys may not
be used for any other purposes. All moneys which will be in the custody of
RTCOPD pursuant to the above shall be put into the Research Fund of the Faculty
for Pulmonary Research of the State Hospitals, which operates according to an
organisational charter which has been confirmed by the Ministry of Justice, in
accordance with the Foundations Act, currently Act No. 19/1988. The
organisational charter is attached to this Research Contract as Annex C. The
accounting of the above fund shall be the responsibility of SH. The financial
management of the fund can,
4
<PAGE> 6
upon further agreement, be in the hands of its board of directors, according to
the provisions of its articles of association.
3.6. PROVISO ON CO-OPERATION WITH RESEARCH PARTIES UNRELATED TO RTCOPD
The right of receiving payments pursuant to Sub-Chapters 3.3 and 3.4 is based on
the assumption that IE will not pay other parties than RTCOPD and institutions
which employ individual parties within RTCOPD 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. If the Executive Committee is of the opinion that it is
necessary to enter into co-operation with more parties pursuant to the above,
the provisions of Sub-Chapters 3.3. and 3.4. shall be reviewed on the basis that
the total payments from IE to RTCOPD and/or institutions related to them, on the
one hand, and a third party, on the other hand, shall remain unchanged from the
payments specified in Chapters 3.3 and 3.4.
CHAPTER 4
MANAGEMENT AND LIABILITY
Decisions relating to the performance of the Research Project shall be made
jointly by RTAA and IE. A special Executive Committee shall be established,
which shall be composed of three members from each party to this Contract. This
Committee shall supervise the performance of the Research Project. The Chief
Supervisor of the Research Project shall be elected from among the members of
the Executive Committee. It is also the responsibility of the 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. The Executive Committee shall also seek a
settlement of disputes which may arise between the parties to the Contract.
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. In November each year the
Executive Committee shall prepare a budget for 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.
RTAA and individuals within the Team shall not be financially responsible to IE
or other parties with interests in the achievement of the commercial or
financial objectives of the research.
IE shall pay expenses in relation to the procurement of liability insurance for
individuals within RTAA as well as staff employed by them. 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
5
<PAGE> 7
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. This entails
that only information which the Data Protection Commission has authorised access
to may be used.
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 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. 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.
CHAPTER 6
LIMITATION ON CO-OPERATION WITH OTHER PARTIES
RTAA and individuals within the Team promise to work neither jointly nor
separately with other parties on research into the inheritability of allergy and
asthma during the Research Project. If IE or deCODE have contracted with a third
party on the sale of the Research Project, its results or findings, and the
Research Project leads to a discovery which has financial significance for IE,
RTAA 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 five years immediately following the conclusion of the Project
as defined in 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 research into the
inheritability of allergy and asthma after the Research Project has ended.
Notwithstanding the provisions of Paragraph 1, individuals within RTAA shall be
permitted to complete research projects in which they are involved with a third
party which began before the making of this Contract.
IE promises not to begin collaboration with other parties in the research of the
inheritability of allergy and asthma during the Research Project, unless the
Executive Committee considers such collaboration necessary to achieve the
objective of the Research Project. If 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, RTAA 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
6
<PAGE> 8
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 on which this Contract has
been both signed by the parties to the Contract and confirmed in signature by SH
in accordance with Paragraph 2 of Chapter 2 of the Institutions Agreement.
The Research Project shall have a duration of five years immediately following
the effective date of this Contract, unless completed before such time 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.
On completion of the Project, the return of all original materials of RTAA shall
be returned to RTAA, unless an agreement to the contrary is made between RTAA
and IE, e.g. if the materials are used in another research, on the condition
that the approval of the participants and a permit from the public authorities
with the authority to permit such an arrangement have been obtained. The return
of research materials from SH on completion of the Research Project shall be
conducted in accordance with Paragraph 5 of Chapter 6 of the Institutions
Agreement.
In the event that either or both parties see reason to continue the co-operation
after the agreed period, this shall be considered separately.
Notwithstanding a 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 month 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.
7
<PAGE> 9
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.
8
<PAGE> 10
This Contract, which comprises 8 chapters on 9 pages, in addition to Appendices
A, B, and C, is made in two identical copies, one copy to be held by each of the
parties to the Contract.
Reykjavik, 1 July 1999.
On behalf of the Research On behalf of Islensk Erfdagreining ehf.
Team for Allergy and Asthma
David Gislason [sign.] Kari Stefansson [sign.]
Senior Physician, SH President of IE
Porarinn Gislason [sign.] Kristjan Erlendsson [sign.]
Senior Physician, SH VP for Clinical and Academic
Collaborations
Unnur S. Bjornsdottir [sign.]
Specialist, SH
SH hereby confirms this
Research Contract on its behalf,
Reykjavik, 20 August 1999
Magnus Petursson [sign.]
9