(Answer provided by Alyssa Shepard, Director HJF Services and approved by Jeb Baker and Mac McDaniel (General Councils for USU and HJF, respectively) and Carol Lavrich, who oversees MTAs, 4-23-07).
Research materials can be biological materials such as plasmids, hybridomas, or cell lines; chemical materials such as drugs, or even animals such as knock-out mice. For a variety of research purposes, research materials are often exchanged between and among academic institutions and commercial entities. Material Transfer Agreements (MTAs) define the legal rights of both the entity transferring the material and the entity receiving the material. MTAs also govern the use and distribution of any material or intellectual property derived from the material that has been transferred. MTAs are required for the transfer of ANY and ALL research material to or from USU, whether proprietary or not. Separate and apart from the material transfer, if the parties wish to keep certain information, knowledge, or data confidential between them, such information is generally transferred pursuant to a Confidential Disclosure Agreement (also known as a Nondisclosure Agreement).
USU's Joint Office of Technology Transfer (the "JOTT" - which is composed of HJF and USU personnel) is responsible for the negotiation and review of MTAs to ensure conformity with institutional policies and proper handling of intellectual property rights. USU researchers who plan to exchange any research materials with outside individuals or entities are required to contact the JOTT for assistance in preparing and executing the appropriate documents; this policy applies regardless of whether the USU researcher is receiving incoming materials or is transferring outgoing materials.
For material transfers with non-federal individuals or entities, an official at HJF signs the agreement. For transfers to federal institutions, an official at USU signs the agreement. For incoming materials, the faculty member involved in the research also will sign the agreement, acknowledging the terms of the transfer. For all transfers, the JOTT will provide the researcher with a Material Transfer Request (MTR) form, which is a checklist of questions to be completed by the PI to facilitate negotiation of the agreement.
For both incoming and outgoing transfer of human-derived material, or if human beings will be involved in the research related to the material transfer, Institutional Review Board (IRB) approval must be in place before the MTA can be executed. Likewise, Institutional Animal Care and Use Committee (IACUC) approval is necessary for incoming transfer of research animals, or if you plan to use the material in animal research. If you believe that your project is IRB or IACUC exempt, please obtain a waiver letter from the IRB and IACUC review officials, because this letter is required before the MTA can be executed. Some materials (hazardous or restricted agents) may be subject to additional regulations that will require coordination with USU's Environmental Health and Occupational Safety Office, as well as registration with the appropriate state or federal agency, before an MTA can be executed.
Materials Coming into the University:
Transfers between USU and another academic institution are facilitated by use of the Uniform Biological Materials Transfer Agreement (UBMTA), which provides standard terms that have been pre-negotiated. USU and many other institutions are signatories to this Agreement. When an academic institution is not a signatory to the UBMTA, or when materials are patented or involve human subjects, the providing institution may require the use of its own MTA model, which generally requires time for negotiation between the institutions. As a general rule, it is best to request the preparation of an MTA as far ahead of time as possible, well before you actually need to start using the material in your research. New faculty members coming to USU should ensure that MTAs are negotiated between USU and their prior institution for any materials that they wish to transfer to their USU research program for ongoing research. Similarly, exiting faculty members who are moving to another research position and wish to take materials with them from USU must have an MTA negotiated between USU and their new institution.
Transfers from commercial entities will generally require case-specific review of agreement terms to ensure that USU's and the faculty member's interests are adequately protected. Negotiation of MTAs with for-profit organizations usually take more time in order to ensure adequate protection of the various and sometimes competing commercial interests.
Materials Leaving the University:
For transfers of material to another academic institution, the UBMTA will be used as a starting point for negotiation, if the other academic institution is also a signatory to the UBMTA and agrees to use it.
If the material is being transferred across international boundaries or to a foreign national located in the United States, the material may be subject to export controls requiring a license from the Commerce Department (if the material appears on the Commerce Control List) or, in some cases, the State Department (if the material appears on the Munitions List).
For transfers of proprietary materials that you have developed to a commercial entity for its research purposes, the JOTT often can negotiate a limited use license agreement for internal research purposes. If the company wishes to resell the materials for research purposes to other researchers, the JOTT can negotiate a commercial license. Likewise, if the company wishes to make a diagnostic or therapeutic product from your materials, a commercialization license would be required.
If you have any questions, or to initiate an MTA or other type of agreement, please call the JOTT at 301-295-0450 or 301-294-1223 or email at firstname.lastname@example.org. The JOTT has a part-time office in the modular building behind Bldg A and a full-time office at HJF in Bethesda.