Model documents on Material Transfer
Introduction

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.

Prerequisites

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

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:

  • description of the Material provided;
  • packaging, transportation, insurance etc;
  • the amount of financial contribution.

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

The Provider:
  • Is obliged to transfer the material to the Recipient and enable him to use it according to the MTA provisions.
  • Retains ownership (or custody) of the transferred research material, as well as of the progeny and unmodified derivatives of the original transferred material.
  • Stipulates to have results of research reported to him.
  • May stipulate to have access to the reports and publications the Recipient intends to release, in order to protect any confidential information and to be informed of any intellectual property rights that the Recipient's research into his material may have generated (not stipulated in the model).
  • Stipulates that the Recipient can only use the research material in accordance with the MTA provisions, and does not have the right to use it for Commercial Purposes.
The Recipient:
  • Has the right to use the Material in his own research activities according to the provisions of the MTA.
  • Has the right to publish the results of the research carried out under the MTA in accordance with its provisions.
  • Retains the ownership of the modifications to the transferred Material and modified derivatives made through his research activities (but not of the original material included in these modifications).
  • Cannot commercialize the transferred research Material or otherwise use it for commercial purposes.
  • Cannot transfer the Material to any third party, except if it has previously been authorized by the Provider.
  • Can only use the transferred Material on its own premises (offices and laboratories). If the transfer is made to the advantage of one specific member of the Recipient's staff, the material can only be used by this scientist and his/her team, under his/her direction, and not by any other scientist working for the Recipient.
Stipulated and negotiated provisions
  • Visa versa obligations of confidentiality;
  • Provisions relating to the ownership of the intellectual property rights arising from the use of the transferred research Material (such as patents);
  • A disclaimer aimed at reducing or waiving the Provider's responsibility as to the risks involved in the use of the transferred material;
  • Publications.
  • Further 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.

 



Copyright (c) BrainNet Europe, coordinated by the Centre for Neuropathology and Prion Research, Ludwig- Maximilians-University Munich, Germany. Tel.: +49-89-2180-78001

Video BrainNet Europe


Click to watch the video.