Voorbeeld van een Material Transfer Agreement (MTA) tussen de Radboud Biobank en een
(buitenlandse) onderzoeker na goedkeuring van het onderzoeksprotocol.
De juristen van de afdeling Valorisatie kunnen assisteren met het aanpassen van te tekst op
individuele situaties.
MATERIAL TRANSFER AGREEMENT
This agreement (hereinafter referred to as “this Agreement”) is made and entered by and between:
Stichting Katholieke Universiteit, doing business as the Radboud university medical center
established at Geert Grooteplein 10 P.O. Box 9101 6500 HB Nijmegen, the Netherlands, legally
represented by the undersigned, hereinafter referred to as “Provider”
and
…, legally represented by the undersigned, hereinafter referred to as “Partner”.
Provider and Partner hereinafter also individually referred to as “Party” and together as ‘Parties’.
Considering that:
a)
Provider has obtained Material further described herein below;
b)
Provider has been requested to provide Partner with said Material for use by Partner’s Scientist
for the purpose of the Partner’s Research Project as described below;
c)
Provider agrees to provide its Material and Partner agrees to receive the Material subject to the
terms and conditions specified below;
d)
Provider has certain information concerning the Material mentioned herein below;
e)
Such information, data and know-how are considered by Provider to be secret and confidential
and constitute a valuable commercial asset to Provider;
f)
Parties are willing, subject to the terms and conditions hereof, to respectively supply and
receive Material and such information, data and know-how for no other purpose than the
validation of the Partner's Research Project, as described below (the ‘Purpose’).
Partner's Scientist:
Name
Address
Provider’s Scientist
Name
Address
Tel:
Fax:
e-mail:
Tel:
Fax:
e-mail:
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Article 1. Definitions
For purposes of this Agreement
1.1
“Material” shall mean human biological material, as provided by Provider to Partner under
this Agreement, and as specified in Annex I to this Agreement, including any progeny thereof.
1.2
“Derivatives” shall mean materials made by Partner directly derived from the Material of
Provider, but that are not Modifications.
1.3
”Partner's Research Project” shall mean the research project specified in Annex II to this
Agreement.
1.4
“Dependent Inventions” shall mean any and all inventions that are conceived and reduced to
practice by Partner in the conduct of Partner’s Research Project and that use or otherwise
incorporate, the Material and/or Derivatives thereof, irrespective of whether such inventions
are patentable or not.
1.5
“Effective date” shall mean the date of the last signature on this Agreement.
1.6
"Confidential Information" shall mean all information, know-how, data and experience of
Provider, regarding the Material, its characteristics, Provider’s previous research concerning
the Material, Partner’s research concerning the Material, Partner’s Research Project,
whether of a scientific, technical, engineering, operational, or economic nature, supplied to
or obtained by Provider or Partner in written form, in the form of drawings or in the
recording of oral conversation, or samples, which is reasonably required by Provider or
Partner for performance of Partner’s Research Project.
1.7
“Incidental Findings”: shall mean the new finding that particular Material carries in it
information that indicates that the donor of the Material runs a real risk of developing a
serious medical condition.
1.8
“Modifications” shall mean Substances created by Partner which contain/incorporate the
Material.
Article 2. Ownership and use of Material
2.1
Provider is, and shall continue to be, the owner of its Material, which will be transferred to
the Partner as a loan for consumption, to be used in the Partner’s Research Project.
2.2
Partner shall use the received Material solely for the non-commercial purposes of the
Partner’s Research Project specified in Annex II to this Agreement. All use of the Material by
Partner in the Partner’s Research Project shall be under the direction of Partner 's Scientist,
and shall only be carried out by persons working under Partner 's Scientist's direct
supervision.
2.3
Use and storage of the received Material shall be limited to the premises of Partner only
2.4
Partner shall not transfer or otherwise make available the received Material to any third
party or entity without prior written approval of Provider.
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2.5
Partner shall not carry out the Partner’s Research Project using the received Material with
any for-profit third party or for-profit entity without prior written approval of Provider.
2.6
Partner agrees in its use of the received Material to comply with all applicable statutes,
regulations and guidelines, including any public policy, statutory or common law, or
governmental or international regulations (collectively, “Regulations”).
2.7
Partner will use the received Material according to professional standards.
2.8
In case any of the patients from which the Material was obtained, makes it known that
he/she withdraws his/her permission to perform scientific research on the Material provided
by him/her, Provider will inform Partner of that fact without delay. Provider shall provide
sufficient coded information to Partner, so that Partner may identify the relevant Material.
That Material shall either be destroyed by Partner without delay or be shipped to Provider
and shall not be used for further research.
2.9
Partner shall not use the received Material for anything other than the Purpose without
obtaining prior written permission thereto from the Provider. Partner may request approval
for additional genetic tests by informing Provider of those tests (by providing gene and
polymorphism data). Provider will treat the information on the planned genetic test
confidential in accordance with article 4 of this Agreement.
2.10 As a consideration for Receipt of the Material, to cover Provider costs related to the
collection, storage and transfer of the Material, Partner shall pay to Provider the amount
agreed upon (quote reference number below) within 30 days after shipment of the Material,
using the following account details:
Bank:
IBAN:
Reference: …
2.11
Any genotyping data that may be obtained from the received Materials by Partner will be
shared with Provider. Provider may add that data to its genotype database and use it for its
own non-commercial clinical, research and educational purposes, but will not be allowed to
publish that data without prior written approval thereto from Partner.
2.12
Partner will report any Incidental Findings to Provider.
2.13
Partner agrees not to make any attempt to identify the patients from which the Material was
obtained.
Article 3. Derivatives, Modifications, Improvements, Inventions and Patents.
3.1
Partner shall be free to develop Derivatives and Modifications from Received Material only as
part of, and only for the purposes of the Partner’s Research Project specified in Annex II to
this Agreement. The use of Derivatives and Modifications by Partner shall be subject to the
same terms and conditions as specified in Article 2 of this Agreement.
3.2
Partner shall inform Provider forthwith of any Derivatives or Modifications of the received
Material, and shall give Provider all relevant details concerning the said Derivatives and
Modifications, which Provider shall treat as Confidential Information.
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3.3
Partner shall be the owner of the Derivatives and Modifications to the extent developed by
Partner but Provider is, and shall continue to be, the owner of the Material that is contained
in Modifications. Partner shall make available to Provider a reasonable quantity of any
Derivatives and Modifications for research purposes upon request and if this is possible for a
reasonable cost and benefit view for said Derivatives.
3.4
Ownership of inventions shall follow inventorship in accordance with US patent law. In case
of Dependent Inventions that are jointly created with employees of Provider (“Joint
Inventions”) or possibly patentable Derivatives or Modifications, Partner and Provider shall in
good faith negotiate the terms of a separate agreement pertaining to the management of
intellectual property and commercialization of such Joint Invention, Modification or
Derivative.
Article 4. Term of Confidentiality.
4.1
Partner shall treat as Confidential Information, for the duration of this Agreement including
any extension thereof and thereafter for a period of three (3) years following termination or
expiry of this Agreement, any information pertaining to the received Material provided to
Partner by Provider or Provider’s Scientist and any other Confidential Information as
disclosed by Provider or Provider’s scientist. For the avoidance of doubt: this duty of
confidentiality shall not apply to any Confidential Information that is published in accordance
with the procedures contained in clause 5 of this Agreement.
4.2
Provider shall treat as Confidential Information, for the duration of this Agreement including
any extension thereof and thereafter for a period of three (3) years following termination or
expiry of this Agreement, any result from Partner’s Research Project and any other
Confidential Information as disclosed by Partner. For the avoidance of doubt: this duty of
confidentiality shall not apply to any Confidential Information that is published in accordance
with the procedures contained in clause 5 of this Agreement.
4.3
Excluded from this obligation shall be any information that was previously known to the
Parties meant in articles 4.1 and 4.2 or that is, and/or that becomes, publicly available during
said three (3) year period through no fault of the Parties meant in articles 4.1 and 4.2 and/or
which is disclosed without confidentiality obligations by a third party having the right to
make such disclosure and/or is independently and lawfully developed by the Parties meant in
articles 4.1 and 4.2.
4.4
This obligation of confidentiality shall not apply to any disclosure required by law, provided
that the Party involved shall notify the other Party of any disclosure required by law to permit
the original disclosing Party to object, if that Party so desires.
Article 5. Publication and acknowledgement.
5.1
Parties acknowledge the importance of disseminating the results of the Partner’s Research
Project. Therefore, Parties shall endeavor to publish or otherwise publicly disclose
information, any data, results or information generated using the Material by Parties for noncommercial or academic purposes, after review by the other Party. Before doing so, each
Party shall adhere to the following procedure:
a) A Party prior to each submission to a publisher and/or intended publication and/or
presentation (hereinafter jointly referred to as ‘Disclosure’) shall provide the other Party
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b)
c)
d)
with a copy of the manuscripts disclosing said information. This should not be less than
fourteen (14) days prior to Disclosure by the Party that wishes to publish, with the
purpose to protect the results, Confidential Information and all (intellectual) property
rights of the other Party. To allow for rapid submission of manuscripts both parties
process manuscripts as fast as possible.
If within fourteen (14) days after receipt of said manuscript by a Party and before
approval of the other Party, the other Party discovers information in this manuscript,
which is the property of that other Party and which needs to be patented and/or
protected in another way, the Party that wishes to publish, after notification thereof by
the other Party, is obliged to delay the Disclosure of concerning information up until a
maximum of thirty (30) days, and thus enable that other Party to secure adequate
intellectual property protection.
In every Disclosure by Partner based upon results obtained from the research through
the help of the received Material and/or other contributions provided by Provider,
Partner shall mention a Provider’s scientists as Material contributor. Authorship shall be
determined in accordance with ICMJE guidelines.
In every Disclosure by Partner based upon results obtained from the research through
the help of the received Material and/or other contributions provided by Provider and
issued by the Radboud Biobank, partner shall acknowledge and name the Radboud
Biobank as source of the material and data, if applicable in the Methods section and the
Abstract . Reference will be made to the descriptive article Manders et al. Radboud
Biobank: a central facility for prospective clinical biobanking in the Radboud university
medical center, Nijmegen. OA Epidemiology 2014 Feb 10;2(1):4.
Article 6. Representations and Liability
6.1
Partner acknowledges that any Material delivered to it under this Agreement is experimental
in nature. Provider makes no representations nor extends any warranties of any kind, with
respect to its Material and/or any Derivatives. There are no express or implied warranties of
merchantability or fitness for a particular purpose, nor does Provider represent that its
Material, any Derivatives and/or any use thereof will not infringe any patent, copyright, trade
secret, trademark or other rights of third parties.
6.2
Provider warrants that its Materials were obtained from patients that gave permission to use
their Material for scientific research.
6.3
To the extent allowed by law, Partner assumes all liability for damages which may arise from
use, storage, transport or disposal of the received Material and/or any Derivatives, unless
that use, storage, transport or disposal was done in reasonable reliance on Provider’s
instructions.
6.4
Provider shall under no circumstance be liable to Partner for any loss, claim, or demand by
Partner, or made against Partner by any other party, due to or arising from the use, storage
or disposal of the received Material and/or any Derivatives, unless that use, storage,
transport or disposal was done in reasonable reliance on Provider’s instructions.
Article 7. Duration and Termination
7.1
This Agreement shall become effective on the Effective Date and will terminate on the <…>,
unless extended by both Parties in writing.
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7.2
If Partner or Provider wishes to extend the duration of this Agreement, it shall request the
other Party in writing for such an extension.
7.3
It is understood that any extension of the duration of this Agreement pursuant to Article 7.2
shall not be unreasonably withheld by one of the Parties, other than for reasons of nonperformance of any part of this Agreement by the other Party; for reasons of non-use of the
Material and/or Derivatives by the other Party; and/or for reasons involving commercial
considerations, including but not limited to the granting by one of the Parties to any third
party of any royalty-bearing exclusive license relating to the Materials and/or being under
any patents, patent applications and/or other property rights covering the Material.
7.4
Upon termination of this Agreement, Partner shall immediately discontinue its use of the
Material and any and all Derivatives from the Material; and shall also, upon the written
request of Provider, return to Provider or destroy any remaining Material as well as any and
all Derivatives from the Material. If any Material and/or Derivatives are destroyed by Partner
pursuant to this Article 7.4, Partner shall, upon the written request of the other Party,
provide Provider with confirmation thereof in writing.
Article 8. Survival
8.1
Articles 3.4, 4, 5, 6.1 – 6.4, 7.4 and any such other provisions of this Agreement which shall
be expected or intended by its nature to survive the termination or the expiration of this
Agreement, shall survive the termination or the expiration of this Agreement.
Article 9. Miscellaneous.
9.1.
This Agreement will be construed, governed, interpreted and enforced according to the laws
of the Netherlands. All disputes arising out of or in relation to this agreement will be brought
before the competent court in Arnhem, the Netherlands.
9.2
Except as expressly provided under this Agreement, no rights or licenses are granted or
provided to Partner with respect to the Material, with respect to any information pertaining
to the Material, and/or under any patents, patent applications, trade secrets or other
proprietary rights of Provider.
9.3
Any notice or communication required or permitted to be given by any Party hereunder will
be deemed sufficiently given if mailed by certified mail, return receipt requested, and
addressed to the party to whom notice is given as follows:
If to Partner, to:
Name:
Address:
Tel:
Fax:
e-mail:
with a copy to:
Name:
Address:
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Tel:
Fax:
e-mail:
If to the Provider, to:
Name:
Address:
Tel:
Fax:
e-mail:
with a copy to:
Technology Transfer Office
R903 DirVal
Radboud university medical center
P.O. Box 9101
6500 HB Nijmegen
The Netherlands
Secretariaat@val.umcn.nl
9.4
This Agreement will be binding upon and inure to the benefit of the respective successors
and assignees of the Parties hereto. However, Parties may not assign this Agreement in
whole or in part without the prior written consent of the other Party.
9.5
This Agreement represents the entire Agreement among the Parties with respect to the
subject matter hereof, and may only be altered or amended by an instrument in writing
signed by both of the Parties.
9.6
If any portion of this Agreement is in violation of any applicable Regulation, or is
unenforceable or void for any reason whatsoever, such portion will be inoperative and the
remainder of this Agreement will be binding upon the Parties. It is understood, however, that
this Agreement shall supersede any agreement, including but not limited to any interinstitutional agreement that a party may have with any third party. Both Parties represent
that they are not aware of any such agreements with any third party that might affect its
ability to meet any of its obligations under this Agreement.
9.7
If the lawful performance of any part of this Agreement by a Party is rendered impossible by
or as a result of any cause beyond such Party's reasonable control, such Party will not be
considered in breach hereof as a result of failing so to perform.
9.8
In case of disputes where this Agreement does not provide a decisive answer, the Parties will
consult each other before taking legal action.
9.9
Partner, if required by Provider, will pay all costs of transportation of the Material from
Provider to Partner and, if necessary, costs of transporting unused Material from Partner
back to Provider.
9.10
All general terms and conditions of Parties are declared not to be applicable to this
Agreement.
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IN WITNESS WHEREOF, the parties have executed this Agreement, in duplicate originals, as
of the Effective Date.
For the Stichting Katholieke Universiteit, doing
business as the Radboud university medical center
For … Institute
Dept. …
By:______________________________________
Dr. D. Masman
Director of Valorisation / Tech Transfer
Date:__________________
By:__________________________________
Name
Date:__________________
By: __________________________________
Name
Date:__________________
For the Department of …
By:______________________________________
Name
Head of the Department …
Date:__________________
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ANNEX I Description of the original material
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ANNEX II Recipients research project
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