It is important that the purpose of the MTA and the purpose of the use of the samples and associated data is detailed clearly in the text. This effectively provides the boundaries on what can and cannot be done with the materials. It might be accomplished in a general overarching manner (e.g. the purpose of the transfer is for pathogen characterization studies), in which case a separate section near the start of the agreement might suffice.
WHEREAS this Materials Transfer Agreement sets out the understanding of the Parties with respect to the provision of Materials by the Provider to the Recipient, who wishes to use the Materials for the Purpose, subject to the terms and conditions of this Materials Transfer Agreement.
NOW THEREFORE, in consideration of the foregoing, the mutual covenants and obligations contained in this Materials Transfer Agreement, and other good and valuable consideration, the Parties will adhere to the following conditions:
The purpose of and materials included in the transfer could also be dealt with in the section for definitions.
A dedicated section on the purpose of the transfer might be replaced or supplemented by more detailed descriptions of specific tests, reagents, and activities permitted for use in the relevant section later in the MTA and detailed in a Materials Transfer Document to accompany the samples and associated data.
Provider will deliver to Recipient the Materials and associated data. Subject to the terms and conditions of this Materials Transfer Agreement and its MTD, Provider hereby grants Recipient the right to use the Materials and associated data for the Purpose, during the Period of Use unless terminated earlier or unless extended by written mutual agreement of the Parties.
Wherever it is addressed, it is important that the purpose accurately captures the needs of the transfer. This will probably be context specific. For example, the purpose of an MTA to move samples and associated data into a biobank for longer term storage is different from a transfer for pathogen characterization studies, which is also different for use in developing vaccines or therapeutics.
This section could include language to:
Describe the purpose of the transfer - such as for public health purposes
Describe the purpose of the transfer - such as for research purposes
Describe the purpose of the transfer - such as for the promotion of research collaborations
Enable certain types of activities - such as enabling commercial purposes
Prevent certain types of activities - such as proscribing commercial purposes
Describe requirements for any further use of transferred materials
It may also be necessary to refer back to the purpose of the MTA in other areas of the text e.g. when dealing with duration or for detailing provisions for additional uses.
Defining the material and associated data being transferred is important for several reasons:
It can help establish the scope of activities allowed under the MTA and exclude certain activities (e.g. cloning or combining the virus with something else).
It will clarify the coverage of derivatives or progeny from the original materials.
It will help to address the changing nature of pathogens which will continue to mutate and evolve over time, thereby preventing the need to renegotiate MTAs unnecessarily due to natural biological processes.
The definition might include the matrix (serum, feaces, swab, etc.). It could also include the volume, or number of reliquats of materials being transferred.
The MTA might also:
Specify that terms and conditions of the MTA also applies to any progeny from the samples
Describe how the materials should be transferred
Address the inclusion of protocols for the handling, storage and safety of the samples
It is also important to define and organise any data accompanying the material as it could identify the subject or patient from whom it was taken. This can necessitate addressing confidentiality issues, including an expectation that all data associated with the samples is anonymised.