Material Transfer Agreement

Definition and Purpose

What is a Material Transfer Agreement?

A material transfer agreement (MTA) is the contractual instrument used to define the terms and conditions for the transfer of materials. The MTA defines the rights of the provider and the recipient to the materials and any derivatives; it defines the duties of the recipients and their institutions, including the responsibility to properly handle, use and dispose of the materials according to applicable laws and regulations.

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.

The use of MTAs is widespread in today's research and development environment, appearing in transfers of materials to and from universities, government agencies, commercial firms, nonprofit organizations and others. Depending on the type of the recipient and provider institution, different agreements are used.

Transfer of Materials between Academic or Non-Profit Institutions

Even though material transfers between academic colleagues at different universities is routine, the use of formal MTAs for such transfers is encouraged by academic and NIH principles. An MTA is required if a material to be transferred includes material owned by a third party provider. The National Institutes of Health and the Association of University Technology Managers developed a standard agreement format to facilitate such material transfers for non-commercial purposes, the Uniform Biological Material Transfer Agreement (UBMTA).

Material Transfer from Industry to UConn

Transfers from industry to academia are more complicated due to the different objectives and cultures of the two parties. For such transfers, UConn is usually required to use the agreement drafted by the company providing the materials. These MTAs are typically more restrictive and may contain language that needs to be negotiated to ensure that University policies and requirements of funding agencies are met.

Problematic Terms in MTAs

• Confidentiality/Publication. When confidential information is exchanged along with the material and/or the MTA stipulates that the material itself is to be treated as company confidential information, an investigator could be prohibited from publishing the results of the work using such material. In addition, companies often request that the results obtained through the use of their materials be held confidential. If the material is crucial for the research project, there may not be anything left to publish. Similarly publication restrictions in MTAs often limit academic freedom by granting the provider the right to approve publications, to have unrestricted pre-publication editorial rights, or to impose excessive publication delays.
• Definition of material. Corporate MTAs also often include in the definition of material modifications or derivatives made from the material that incorporate the university investigator's original ideas or concepts. Consequently, the provider may own the results of the investigator's research and could prevent him/her from using these results in further research or publish them.
• Intellectual property. Some providers require that recipients of their materials relinquish all claims to ownership of any new materials created by the recipient or inventions made through the use of the provided materials. This not only represents a loss of intellectual property rights, but also may prevent the recipient from continuing a line of inquiry because he/she no longer has the right to use his/her research results.
• Indemnification. MTAs commonly require that the recipient institution indemnify the provider against any damage that may occur through use of the material. As an agency of the State of Connecticut, per Attorney General Opinion, UConn is not permitted to provide such indemnification of the provider as part of any contract including MTAs.

Compliance

Cell lines/biological materials may not be used in connection with human subject, animal subject, or recombinant DNA activity in the absence of protocol(s) approved by the appropriate University of Connecticut Committee(s):

• MTAs for live animals or custom antibodies must have protocol(s) reviewed and approved by the UConn IACUC.
• MTAs for human tissue must have protocol(s) reviewed by the UConn IRB.
• MTAs for hazardous materials and/or select agents must follow EH&S compliance procedures.
• MTAs for human embryonic stem cells can only be used on projects that have Embryonic Stem Cells Research Oversight Committee approval.

Export Control

Under U.S. export control laws, a license may be required from the Bureau of Export Administration 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 and plant pathogens. An investigator planning to transfer materials that are controlled by the Export Administration Regulations outside the United States should work with OSP to obtain the required license. There are civil and criminal penalties for violating the Export Administration Regulations. For more information, consult the OSP website.

Transfer of Toxic Biological Agents

The University also has to comply with laws and regulations covering possession, use, and transfer of certain biological agents and toxins that have the potential to pose a severe threat to public health and safety (the so-called, “select agents”). The Centers for Disease Control and Prevention (CDC) regulates the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. The CDC Select Agent Program oversees these activities and registers all laboratories and other entities in the United States of America that possess, use, or transfer a select agent or toxin. For more information, consult www.selectagents.gov

Material Transfer from UConn to Industry

The transfer of materials from UConn to corporations, while generally permissible, requires a commercial MTA, which differs from the MTAs used for the transfer of materials between academic institutions. Unlike non-profit MTAs, commercial MTAs generally require the payment of a fee by the corporation in exchange for the materials. Fees can vary widely based on the complexity of the materials and their intended use by a corporation; as such, commercial MTAs are drafted and negotiated on a case-by-case basis. Fees received for the transfer of materials are distributed according to the revenue sharing policy of the University. It should be noted that materials created at UConn that incorporate components obtained from third parties may require permission from the third party provider before transfer to a corporation is possible.

Procedure and Signatory Authority

The Center for Science and Technology Commercialization (CSTC) creates and processes all MTAs that cover transfers of research materials from UConn to another institution, both non-profit and for-profit. For such transfers, contact the CSTC’s Executive Director, Michael Newborg, by phone (860 679-2518) or email.

OSP’s Contract Services unit reviews and approves all MTAs for incoming materials. For these MTA, complete the Biological Materials Registration or the Human Embryonic Stem Cell Registration form, as applicable (link). Submit the completed form with the MTA and any pertinent approvals to the OSP. OSP will negotiate the terms of the MTA if necessary, process it for signatures, and will forward a copy to you when fully-executed. For questions contact Antje Harnisch, by phone (486-3994) or email.

All agreements that bind the university, including MTAs, must be signed by an official of the institution who has signatory authority. Agreements that are not signed by an authorized institutional official may not be valid and may make the signor personally responsible for any breach of the terms and obligations of the MTA. The investigator may also sign the agreement, not as a party to the agreement, but as an acknowledgement of his or her duties under the agreement.

Forms

• Biological Materials Registration Form
• Human Embryonic Stem Cell Registration Form

Resources

UConn Export Control Compliance Program

UConn Center for Science and Technology Commercialization

Council on Government Relations:
"Materials Transfer in Academia"

UC Office of Technology Transfer:
Biological Materials Transfers links

Association of University Technology Managers: UBMTA

National Institutes of Health:
"Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources"
http://ott.od.nih.gov/RTguide_final.html

Bayh-Dole Act:
"Rights to Inventions Made by Nonprofit Organizations and Small Business Firms under Government Grants, Contracts, and Cooperative Agreements—Patents, Trademarks, and Copyrights" - 37 CFR Part 401

National Select Agent Registry