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For Non-Commercial Use

Ref. P0741/P0810
DATA TRANSFER AGREEMENT
This Data Transfer Agreement (“Agreement”), effective upon signing by both Parties, is
concluded between the University of Oulu, Northern Finland Birth Cohort (NFBC) and
Hospital del Mar Medical Research Institute (IMIM).
PROVIDER: University of Oulu
P.O.Box 8000
FI-90014 University of Oulu FINLAND

Provider Scientist:

Minna Ruddock, Research Director in the Northern Finland Birth Cohort Studies,
Faculty of Medicine, minna.ruddock@oulu.fi

Contact person at the NFBC Project Center:

Maarit Kangas, Project Coordinator in the Northern Finland Birth Cohort Studies,
Faculty of Medicine, maarit.kangas@oulu.fi

RECIPIENT: Hospital del Mar Medical Research Institute (IMIM)

Carrer del Doctor Aiguader 88, Floor 1, 08003 Barcelona, Spain

Recipient Scientist: Francesco Gualdi, Researcher in the Integrated Biomedical


Computing Research Group, fgualdi@imim.es

The Provider and the Recipient are hereinafter referred to jointly as “Parties” and
individually as “Party”.
For Non-Commercial Use

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1. Background

1.1. The Provider has collected and owns the Data sets and collections of Data derived
from information provided by participants in the Northern Finland Birth Cohort 1966
and 1986 Studies, http://www.oulu.fi/nfbc/ (“NFBC”).

1.2. The Recipient Scientist wishes to participate in the NFBC and has provided a proposal
to the Provider, which has accepted it, subject to agreement on these terms of access
to the Data.

1.3. This Agreement defines the terms of access to the Data. The Provider will provide
access to the Data according to the procedures set forth by the Provider´s NFBC
Project Center (“NFBC PC”).

1.4. This is a standard agreement used for the NFBC data, and as provider of the data
University of Oulu have set terms for its use and will not accept changes to this
Agreement.

2. Definitions

“Agreement” shall mean this Agreement and its Schedules including any and all
attachments, appendices, addendums and amendments.

“Commercial Purposes” shall mean the sale, lease, license or other exploitation of the Data
or inventions whether for profit or not, including but not limited to, use of the Data or
inventions by Recipient or any individual or organization to perform contract research, to
produce or manufacture products for general sale, or to conduct research activities that
result in any sale, lease, license or other exploitation of the Data or inventions, whether
for profit or not. For the avoidance of doubt, Commercial purposes include also
applications for intellectual property rights such as patents;

“Data” Shall means the Data the Provider has collected in the NFBC and provides to the
Recipient under this Agreement. The Data is defined and described in Appendix A;

“Data Protection Regulation” means all applicable EU and national laws on personal data,
such as the GDPR and the Finnish Data Protection Act (code 1050/2018) or any other laws
replacing them and any other applicable data protection legislation, as For Non-
Commercial Use

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amended from time to time, as well as the instructions and binding orders of the data
protection authorities;

“Data Subject” means any research participants whose Personal Data is processed under
this Agreement;

“GDPR” means the Regulation (EU) 2016/679 of the European Parliament and of the
Council of 27 April 2016 on the protection of natural persons with regard to the processing
of personal data and on the free movement of such data, and repealing Directive 95/46/EC
(General Data Protection Regulation);

“Personal Data” shall mean personal data as defined in Regulation (EU) 2016/679 of the
European Parliament and of the Council (GDPR) including any and all human biological
material and/or register Data and also any subsequent descendants from, derivatives of
and modifications to them as long as they can be directly or indirectly traced back to the
original sample or individual level data;

“Publication” shall mean the publication of theses, articles, scholarly writings or oral or
written presentations at lectures or seminars, or any other form of academic disclosure;

3. Terms and conditions of this Agreement

3.1. The Recipient agrees

a) to use the Data solely for carrying out the experiments and analyses which are
described in Appendix B (“Research”).

b) that any use not described in Appendix B is subject to a prior written consent
of NFBC PC and a separate agreement or an addendum or amendment to this
Agreement.

c) to use the Data only at the Recipient organization and only by the Recipient
Scientist’s research group under the direction of the Recipient Scientist.

d) that to maintain the rights under this Agreement it must obtain the written
consent of NFBC PC before changing the Recipient Scientist.

e) not to transfer the Data in whole or in part to anyone else within the Recipient
organization than the persons authorized herein nor to any third party without
the prior written consent of the NFBC PC.
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For Non-Commercial Use

f) to use, store and dispose of the Data in compliance with all applicable laws,
rules and regulations, this Agreement and the Provider’s written instructions.

g) to submit to the NFBC PC any new data generated from the analyses of Data
upon completion of the analyses, the practicalities for which will be agreed
between the Provider Scientist and the Recipient Scientist where necessary.
The new data can be for example modified variables that could be used in
future research. The Recipient must also submit any relevant documentation
related to the new data to the Provider to facilitate future research.

h) the NFBC PC has the right to incorporate the submitted new data into the NFBC
database to be provided to internal or third-party researchers at the Provider’s
discretion. In such case the Recipient will be acknowledged appropriately in
Publications utilising that data in accordance with the ICMJE
recommendations (www.icmje.org/recommendations/) and as agreed
between the Provider Scientist and the Recipient Scientist.

i) to send to the NFBC PC a manuscript describing the results it has obtained from
the analysis of the Data in the performance of the Research (“Results”) 15 days
before submitting the manuscript. If the NFBC PC does not provide the
Recipient with any objections (such as misinterpretation of the original data or
failing to acknowledge co-authorships as agreed by the Recipient) to the
manuscript within the 15 days, the Recipient is free to publish the manuscript.
The Provider will keep the manuscript confidential and not use it without the
prior written consent of the Recipient.

j) to include as authors those Provider´s employees identified by NFBC PC who


have played a key scientific role in the generation of results in all Publications
arising from the Research.

k) to provide NFBC PC a copy of all accepted Publications (articles and abstracts)


that result from the use of the Data within two months of the Publication if
possible.

3.2. Disclosure of Personal Data

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In case the Recipient wishes to obtain Data from the NFBC-study which falls into the
category of Personal Data determined by the Provider the Recipient agrees as
follows:

For Non-Commercial Use

3.2.1 The Provider has originally determined the means and purposes of the
collection of Data, thereby constituting the owner of the Data and original Controller
of Personal Data.

3.2.2 Subject to the terms and conditions of this Agreement, the Provider shall hereby
disclose Personal Data to the Recipient.

3.2.3 In the processing of Personal Data, the Recipient undertakes to comply with
the current Data Protection Regulation and the official regulations issued
thereunder. The Recipient warrants that it is familiar with the content of the Data
Protection Regulation. Any conduct of the Recipient that is contrary to the Data
Protection Regulation may be considered a material breach of contract. Upon
receiving the Personal Data, Recipient shall constitute an independent Controller of
the Personal Data. As an independent Controller, Recipient represents and warrants
it shall process Personal Data pursuant to the Data Protection Regulation and
undertake all rights and obligations relevant to a Controller.

3.2.4 Recipient shall, for its own part, ensure that Personal Data is processed in
compliance with the Data Protection Regulation, as well as good data processing
practices.

3.2.5 Recipient shall implement continuously appropriate technical and


organisational measures to protect Personal Data as required by the applicable Data
Protection Regulation.

3.2.6 The Provider may at any moment inform the Recipient of a Data Subject
withdrawing their consent or exercising their rights as a Data Subject under the Data
Protection Regulation. The Recipient shall perform all actions necessary in order to
fulfil the rights of the Data Subject and comply with the Data Protection Regulation.

3.2.7 If Provider discloses Personal Data in pseudonymized form to Recipient,


Provider shall have no obligation to disclose the pseudonymization key unless
otherwise specified in this Agreement.

3.3. This Agreement is not transferrable


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3.4. The Provider retains ownership of intellectual property rights pertaining to the Data.

3.5. Without prejudice to any pre-existing rights, the Party who creates the Results owns
any intellectual property rights pertaining to them. The owner of the rights to any
Results hereby grants the other Party a worldwide, royalty-free, non-exclusive right

For Non-Commercial Use

to copy, use, modify and make public the Results for teaching and research purposes
and have third parties to do so, including for the avoidance of doubt the rights for
inclusion in the NFBC database and further use by the Provider and/or third parties as
described in Section 2.1(i) above. If the Parties created any Results together, they will
negotiate in good faith to agree on the details concerning their shared rights at either
Party’s request.

3.6. This Agreement or the Recipient’s rights under or in relation to this Agreement do not
restrict the rights of the Provider, including also those to distribute or otherwise
dispose of the Data or to publish any document relating to the Data, understanding
however, that this Agreement does not restrict any pre-existing intellectual property
rights of either Party.

3.7. The Provider accepts no liability related to the Recipient’s use of the Data. The
Provider disclaims all warranties and representations regarding the Data and its
Results (if any), including those for

a) satisfactory quality or fitness for any particular purpose;


b) the use of Data being free from infringement of third-party rights, including
intellectual property rights.

3.8. The Recipient accepts no liability related to the Provider’s use of the Recipient’s
Results. The Recipient disclaims all warranties and representations with regard to its
Results, including those for

a) satisfactory quality or fitness for any particular purpose;


b) the use of the Results being free from infringement of third-party rights,
including intellectual property rights.

3.9. For the avoidance of doubt, the Provider is not liable for any costs related to the
performance of the Research, unless otherwise specifically agreed in writing. To the
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extent permissible by law the Recipient indemnifies the Provider against and holds the
Provider harmless from any loss, damage or liability howsoever arising from the
Recipient´s use of the Data.

3.10. The Provider provides the Data for non-commercial NFBC research purposes
only. Accordingly, the Recipient may not use its Results for Commercial purposes
without the Provider’s prior written consent and written agreement on the terms,
which the Parties will negotiate in good faith at the Recipient’s request,

For Non-Commercial Use

understanding however that the Provider is under no obligation to consent to any


Commercial purposes.

3.11. Unless extended in writing, the term of this Agreement is five (5) years from the date
of signing. Upon the effective date of termination, the Recipient will discontinue its
use of the Data, and will, upon the Provider’s directions, return or destroy the Data,
including for the avoidance of doubt any and all copies.

3.12. The Provider may terminate this Agreement if the Recipient is in breach of any of the
terms specified herein and if the breach has not been remedied within thirty (30) days
after the date of written notice by the Provider of such breach.

3.13. Amendments to this Agreement must be made in writing and signed by the
authorized representatives of both Parties.

3.14. This Agreement is governed by Finnish law. Any disputes arising under or in relation
to this Agreement will be resolved in the District Court of Oulu. Nothing in this
agreement shall limit the Parties right to seek injunctive relief in any applicable
competent court.

3.15. This Agreement constitutes the exclusive statement of the Data transfer between
the Parties and supersedes all oral or written proposals, prior agreements and other
communications between the Parties concerning the subject matter of this
Agreement, except that any prior commitments related to the privacy and handling of
the Data the Recipient has undertaken in the application phase continue to apply to
the extent complementing this Agreement. The following appendices are
incorporated into this Agreement: Appendix A Detailed description of the Data
provided by the Provider, Appendix B Research proposal, Disclosure of Personal Data
(3.2) prevails over any conflicting terms elsewhere in this Agreement.
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For Non-Commercial Use

AGREED BY THE PARTIES through their authorized signatories

Signed for and on behalf of THE PROVIDER:

Date and place: Signature:

Osmo Tervonen, Dean of the Faculty of Medicine

Date and place:

Signature:

Emma Pirilä, Research Funding Specialist, the Faculty of Biochemistry and Molecular
Medicine and the Faculty of Medicine

Signed for and on behalf of THE RECIPIENT:

Date and place:

Signature:

Andreu Fort Robert, General Manager of Hospital del Mar


Medical Research Institute (Authorized* signatory
of the Recipient)
*Authorizedsigner is a person who has the power to sign on behalf
of the University /Research Institute. Usually Director of
Technology Transfer Office or Head of Faculty / Department.

For Non-Commercial Use

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The Scientists of the Parties acknowledges that they have read and will understand the terms
of the Agreement and follow them.

PROVIDER SCIENTIST:

Date and place:

Signature:

Minna Ruddock, Research director in the Northern Finland Birth


Cohorts, Infrastructure for Population Studies, Faculty of
Medicine

RECIPIENT SCIENTIST:

Date and place:

Signature:

Francesco Gualdi, Researcher in the Integrated Biomedical


Computing Research Group

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For Non-Commercial Use

APPENDIX A - Detailed description of Data that Provider will be providing to the Recipient
(Attach the list of variables)

APPENDIX B - Research proposal (Attach the research plan describing the use of Data)

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