Material Transfer Agreements
The exchange of materials among scientists is a common, and much needed, practice. Material Transfer Agreements (MTAs) are contracts that protect the rights of both the receiver and the provider of these materials. Whether the material is incoming or outgoing, contracts of this type are negotiated by the Office of Industrial Partnerships (OIP) on behalf of the Board of Regents of the University of Wisconsin. In instances where the material is managed by the Wisconsin Alumni Research Foundation (WARF), agreements covering outgoing material associated with WARF-managed intellectual property are negotiated and signed by WARF and could involve licensing fees or cost recovery.
An MTA is a written contract that governs the transfer of tangible research materials. MTAs define the rights, obligations and restrictions for both the provider and recipient with respect to the materials and any derivatives, and any confidential information exchanged with the material. These agreements may include language related to: rights to intellectual property (actual and potential), liability, confidentiality of provider information, publication of recipient research results, permitted use of the material, and other associated legal issues that the provider and recipient may wish to specify in the transaction.
Biological materials, such as reagents, cell lines, plasmids, and vectors, are the most frequently transferred materials, but MTAs may also be used for other types of materials, such as chemical compounds, equipment, and even some types of software. Often these materials are a necessary component of a research project and are prohibitively expensive or wholly unavailable on the commercial open market; in some cases the only source may be a for-profit entity that is still conducting its own research on the material. Chances are good that in such circumstances the for-profit provider will consider its material to be a vitally important proprietary resource. Consequently, the provider may want to assert intellectual property rights to inventions made by the recipient with the provider's material, or restrict publication of research results obtained in research utilizing the material. The University must ensure that MTA terms: permit full dissemination of research results, do not conflict with University or federal policies, and do not conflict with rights afforded in other agreements associated with the research project.
MTAs protect the rights of both the receiver and the provider. Future misunderstandings or disputes are avoided when there is an up front agreement on terms governing the transfer and use of the material and any resulting publications or intellectual property.
MTAs for incoming material typically: protect a researcher's ability to use and publish research results; protect any existing and potential intellectual property; and define the use of any accompanying confidential information. Review of an incoming MTA ensures the agreement terms don't conflict with rights granted in other agreements associated with the research.
Outgoing MTAs prevent the material provider at the UW from losing control over the material and its research use. If no agreement exists, the recipient of the material has no legal restrictions on use or transferring the material. During the processing of outgoing MTAs, Office of Industrial Partnerships staff, along with the UW provider, will review existing agreements relevant to the research to determine if agreements are in place that restrict further transfer of the material or if the material is covered under federal regulations or export control laws.
Researchers must carefully examine all commitments made in the MTA in relation to other funding and material agreements supporting the project. If materials received from one entity and covered by an MTA are to be used in research funded by any other entity, access rights to inventions given to the parties must not conflict. If materials are combined from multiple providers, conflicts in access rights must similarly be avoided. When MTAs are used in conjunction with federally funded research, rights given to material providers to resulting inventions must not conflict with rights to the federal government as provided under legislation known as the Bayh-Dole Act.
The Office of Industrial Partnerships will assess the MTA terms, and work with the provider to modify them as required to ensure that they are consistent with federal and state law, and University policy; are not in conflict with other agreements related to the research; and are in the best interests of the University and the researcher.
Before transferring materials that are part of a pending or issued WARF patent, or assigned to WARF as a "biological material," researchers must contact WARF to be sure the necessary agreements are in place.
The University requires a record (via the WISPER system) be processed before researchers receive research materials. An MTA will be signed by the Office of Industrial Partnerships, on behalf of the Board of Regents of the University of Wisconsin System, when the providing organization requires that an MTA be signed. Investigators may not themselves sign and return MTAs to material providers.
Incoming MTAs typically define: the rights of the provider and the recipient with respect to the materials and any derivatives; the use of any accompanying confidential information; the receiving researcher's ability to use and publish research results; the rights to any existing and potential intellectual property; and the redistribution of the materials to others. A review of the terms of an incoming MTA can ensure that the agreement does not contain terms that conflict with rights granted in other agreements associated with the research.
Processing Outgoing MTAs
If rights to the material are not assigned to WARF then the outgoing MTA is negotiated and signed by the Office of Industrial Partnerships on behalf of the Board of Regents of the University of Wisconsin.
The University requires a record (via the WISPER system) AND an MTA to be processed before researchers provide research materials to third-party organizations. As with MTAs for incoming materials, MTAs for outgoing materials are also signed by the Office of Industrial Partnerships. For intra-institutional transfers, an MTA is not necessary, unless required by the terms under which the materials being transferred were originally received, however a WISPER record still must be created to document the transfer and should list the recipient researcher as the PI.
The University "Policy on Tangible Research Property" is the policy imposing the outgoing MTA requirement, and also provides guidance for the transfer of tangible products of research when a Principal Investigator (PI) leaves the UW–Madison and wants to move his/her tangible research material. This policy also provides guidance for the transfer of tangible products of research when a research contributor, other than the PI, leaves the UW–Madison.
Educational and non-profit organizations are generally willing to transfer material under the terms of the Uniform Biological Material Transfer Agreement (UBMTA), which was developed on a collaborative basis by major research universities, the National Institutes of Health, and the Association of University Technology Managers (AUTM) to facilitate the exchange of research material for non-commercial purposes.
Since UW–Madison and WARF are signatories to the UBMTA, the Implementing Letter is the preferred instrument to use when we receive material from a non-commercial entity and, if possible, for-profit entities as well.
One of the many issues facing research universities relates to the acquisition of various biological and other research materials developed by private industries. Often these materials are a necessary component of a research project and are available only from an industrial source. A company may have expended considerable resources developing the materials and as a result is justifiably interested in the protection of its commercial interests. Likewise, the researcher at the University may have developed a material that is of particular interest to an industrial partner. An MTA is required when a researcher receives material from an industrial partner or sends material off-campus to an industrial partner.
The different missions and goals of industry and universities may mean that MTA terms must be negotiated to accommodate the needs of both groups. Areas of difference usually relate to publication, use of research results, confidential information, and ownership of any intellectual property generated by the research. Since UW–Madison is a State agency, there are also limitations on the amount of liability that the University may accept. Furthermore, research supported by a grant from a federal source or other extramural sponsor may impose additional obligations on the institution that limit what can be promised to an industrial partner.
Most for-profit material providers have their own MTA template, which they offer to UW–Madison as a starting point for negotiation. Whenever possible, it is advisable to use the Simple Letter Agreement. While the UBMTA is used among many universities, this does not hold true for industry. The Simple Letter Agreement accomplishes the same goals as the UBMTA.
Because of the possible issues involved, it is best to allow time for a potentially lengthy negotiation process. However, the Office of Industrial Partnerships (OIP) negotiators make every effort to work with their counterparts in industry to quickly resolve any issues.
Under U.S. export control laws, a license may be required from the Bureau of Industry and Security of the Department of Commerce for the export of certain materials. There are, for instance, controls on the export of materials that could possibly be used in chemical or biological weapons. Examples of such materials include human pathogens, zoonoses, toxins, animal pathogens, genetically modified microorganisms, plant pathogens, radioactive materials, magnetic metals, propellants and ceramic materials.
A Principal Investigator who is planning to transfer materials outside the United States, that are controlled by the Department of Commerce Export Administration Regulations or the Department of State International Traffic in Arms Regulations should work with the UW Export Control Office to obtain the required license. There are civil and criminal penalties for violating the Export Administration Regulations. For more information, consult the UW–Madison Export Control Program website.