© BrainNet Europe II
BrainNet Europe is a "Network of Excellence" funded by the European Commission in the 6th Framework Program "Life Science" (LSHM-CT-2004-503039). It consists of 19 established brain banks across Europe and is coordinated by the Centre for Neuropathology and Prion Research Ludwig-Maximilians-University Munich, Germany.
|Model documents on Material Transfer|
On this page you can find detailed information on the standard operating procedure and model documents which underlie the process of material transfer as developed and used by the Netherlands Brain Bank (NBB). The core objective of the Netherlands Brain Bank is to supply the scientific community with well-documented CNS and other material. The NBB annually receives and reviews a large number of requests. Requests originate from academic researchers, pharmaceutical companies and for profit entities which conduct contract research. The number of requests requires a smoothly running organization of the transfer process.
Material Transfer Process
For detailed explanation of the Material Transfer process please click on the flowchart.
Prior to providing Material to any third party the Brain Bank should acquire detailed information on requestor’s plans for the Material. In some cases the Party requesting the Material from the Brain Bank can be reluctant to disclose details concerning the research project, claiming that this information is confidential or proprietary. In such cases the requestor can be offered a possibility to submit a request under the terms of a Confidentiality Agreement (model presented here below).
Confidentiality Agreement (CA) guarantees that information or know-how that it is about to be disclosed to another person/organization, will not be revealed to third parties.
The model presented here is adapted to the procedure of Material request (Application). A comparable document can also be applied for the exchange of information in the framework of evaluating the possibility of collaboration.
Material Transfer Agreement
A Material Transfer Agreement (MTA) governs the transfer and use of research material that is made available by the Brain Bank ("the Provider") to an academic or research institution or commercial entity ("the Recipient") that wishes to use the material for its own internal research purposes, when at the time of transfer no research collaboration exists between the two contractors.
The MTA defines the rights and obligations of the Parties with regard to Material Transfer.
MTA’ s must be concluded between legal entities, not between individual scientists involved in the transfer and the related research.
An MTA can be signed at every individual transfer of the Material. However in our experience it has been more convenient to sign and maintain an individual MTA with every legal entity (usually university or company) to which the Material is provided. This so-called “framework MTA” covers all incoming requests from scientists employed by or working for that legal entity.
Every individual transfer to that legal entity is recorded in the Implementing Letter containing:
In principle the obligation to inform the scientists of the MTA provision is placed with the legal entity (the Recipient). As a courtesy, a one page extraction of the MTA (a document called Material Transfer Statement) is provided to the researchers in question, for them to be aware of the terms and conditions that are imposed on them by the MTA.
Subject matter: the Material
The term “research material” embraces a wide range of elements. It includes not only the original transferred material, but also its unmodified descendants - called "progeny", derivatives, confidential information (if any), data about the material and associated know-how.
The definition of the Material is crucial, as conflicts may arise from what subsets of Material are used for which purposes. Because Informed Consent given by the donor or Authorization given on behalf of the donor limit the possible uses of the Material to research purposes only, the Brain Bank should take care to ensure that the Material is not used for other purposes such as commercial sale, lease or license of the Material including its subsets defined in the MTA. MTA should contain explicit provisions on this point leaving no room for misinterpretation.
The actual description of the Material can be included in the Implementing Letter, together with further provisions such as preservation requirements, delivery method and financial contribution in the costs of the Material.
Rights and obligations resulting from an MTA
Stipulated and negotiated provisions
It is very useful to include a clause in the MTA that states which national law will apply should a conflict arise in relation to the transfer or the term of the Agreement.