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Office of Research and Development at Wake Forest University School of Medicine


 

Material Transfer Agreements  

 

Process

 

A)  Agreement - Incoming Materials (Company or Academic)

1.  Complete a Material Transfer Agreement Questionnaire (Incoming) and provide the completed Questionnaire and the proposed Material Transfer Agreement (MTA) to Industry Relations.

2.  Industry Relations will review the terms of the proposed MTA and your Questionnaire, following up with you on any further questions as necessary.

3.  Industry Relations will negotiate any required changes, as appropriate, with the company/other institution.

4.  Once an MTA is agreed to with the company/other institution in conformance with institutional policies and requirements, Industry Relations will process the required signatures.

5.  Industry Relations maintains the original fully-executed MTA in their offices, providing the investigator with a copy for his/her records.

6.  If the materials involved include animals that will be under the care of the Animal Resources Program such that they will be assisting you with the receipt of the animals, Industry Relations will notify ARP of the completion of the MTA process for timing purposes of receipt of the animals.

7.  Institutional requirements, including but not limited to Bio-safety, IACUC or IRB, as applicable, must be in place prior to the use of materials received under an MTA in any research project.

 

B)  Amendment – Incoming Materials (Company or Academic)

1.  Provide the proposed MTA amendment to Industry Relations along with further information about the specifics of the purpose for the amendment (e.g., receiving additional quantities of the same material, receiving additional materials, expanding the prior research project).

2.  Industry Relations will review the terms of the proposed MTA amendment and discuss with you how the language affects the additional research to be conducted to confirm that the prior terms are still acceptable and applicable to your research.

3.  Once an MTA amendment is agreed to with the company/other institution in conformance with institutional policies and requirements, Industry Relations will process the required signatures.

4.  Industry Relations maintains the original fully-executed MTA amendments in their offices, providing the investigator with a copy for his/her records.

5.  If the additional materials involved include animals that will be under the care of the Animal Resources Program such that they will be assisting you with the receipt of the additional animals, Industry Relations will notify ARP of the completion of the MTA amendment process for timing purposes of receipt of the animals.

6.  Institutional requirements, including but not limited to Bio-safety, IACUC or IRB, as applicable, must be in place prior to the use of materials received under an MTA amendment in any research project.

 

C)  Agreement - Outgoing Materials (Academic Only)

1.  Complete a Material Transfer Agreement Questionnaire (Outgoing) and provide the Completed Questionnaire to Industry Relations.

2.  Industry Relations will draft a Material Transfer Agreement (MTA), discussing the proposed MTA with you as appropriate.

3.  Industry Relations will provide the proposed MTA to the other institution, as well as discuss any request for changes received from the other institution.

4.  Once a mutually acceptable MTA is finalized, Industry Relations will process signatures as appropriate.

5.  Once the MTA is fully-executed, Industry Relations will provide the Investigator with a copy and upon receipt of that copy the Investigator can ship the materials.

6.  No materials should be shipped without a fully-executed MTA.

7.  If the MTA involves animals that the Animal Resources Program will be providing you assistance on transferring, notification of completion of the MTA process will be provided to ARP for shipment of the animals.

8.  Institutional requirements, including but not limited to Bio-safety, IACUC, or IRB, as applicable, must be in place prior to the transfer of any materials under an MTA to another institution or company.

 

D.  Amendment – Outgoing Materials (Academic Only)

1.  Provide the proposed MTA amendment to Industry Relations along with further information about the specifics of the purpose for the amendment (e.g., sending additional quantities of the same material, sending additional materials, expanding the prior research project).

2.  Industry Relations will review the terms of the proposed MTA amendment and discuss with you how the language affects the additional research to be conducted to confirm that the prior terms are still acceptable and applicable to the transfer of materials.

3.  Once an MTA amendment is agreed to with the company/other institution in conformance with institutional policies and requirements, Industry Relations will process the required signatures.

4.  Industry Relations maintains the original fully-executed MTA amendments in their offices, providing the investigator with a copy for his/her records.

5.  If the MTA involves animals that the Animal Resources Program will be providing you assistance on transferring, notification of completion of the MTA amendment process will be provided to ARP for shipment of the animals.

6.  Institutional requirements, including but not limited to Bio-safety, IACUC or IRB, as applicable, must be in place prior to the transfer of materials under an MTA amendment in any research project.

 

E.   Agreement and Amendments - Outgoing (Companies)

1.  Requests for outgoing materials to companies are managed by the Office of Technology Asset Management (OTAM).  Contact OTAM for further information or instructions on how to proceed with this request. 

 

General Information

A Material Transfer Agreement (MTA) is a contract that facilitates the transfer of various kinds of research material such as biological materials, compounds, and animals for the use in research projects.  It defines the rights of the provider and the recipient with respect to the materials and any derivatives.  Material transfers can be between an academic institution and industry or between two academic institutions. 

 

Academic institution are generally willing to transfer material under the terms of the Uniform Biological Material Transfer Agreement (UBMTA), which was developed on a collaborative basis to facilitate the exchange of research material for non-commercial purposes. If the parties agree either an Implementing Letter or Simple Agreement can be used to confirm that the recipient has signed the UBMTA and is accepting material under UBMTA terms and conditions.  WFUHS is a signatory to the UBMTA, so the Implementing Letter is the preferred instrument to use when receiving material from an academic institution.  Whenever possible, the UBMTA is also the preferred instrument to use when sending materials to another academic institution.

 

Most for-profit institutions have their own MTA templates. Negotiating terms with a for-profit provider can be a complex and time-consuming process, particularly if the provider wants to protect the material or wants to secure rights to inventions that may result from our use of its material.  Negotiations with for-profit material providers are also sometimes complicated by their requirements related to confidentiality, publication and liability related to the use of the material.

 

In transactions with for-profit entities, WFUHS’ approach to intellectual property issues depends in large part on the source of funding that will support our planned research with the material and the objectives of the research as it relates to the investigator’s overall research program.  For example, if an Investigator’s work with material from an outside source is federally funded, regulations under the Bayh-Dole Act are applicable.  WFUHS would grant the for-profit material provider a time limited option to secure a royalty bearing license to inventions that directly result from the investigator’s work with the provider's material.  All other provisions would be negotiated to be consistent with institutional policies and requirements.

 

The use of specific materials may require special consideration due and other contractual requirements.  For example, any materials being received or transferred that are created using the Cre-lox technology would be governed by requirements imposed by DuPont/Bristol-Myers Squibb as the owner of the Cre-lox technology.  Another example of would involve use of the OncoMouse.

 

There are some non-profit repositories of materials that can also be accessed by investigators, such as American Type Culture Collection, Jackson Laboratories, Taconic Farms.  These repositories are not only sources of materials, but places where investigators may wish to deposit materials to make available to other academic institutions on a broader scale.  The process for depositing materials with each of these groups varies.  Consult Industry Relations for further information on this process.