Material Transfer Agreements
A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations. The MTA defines the rights of the provider and the recipient with respect to the use of the materials and any derivatives. 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 and even some types of software. The University of South Alabama (USA) requires MTAs for any incoming or outgoing materials in order to monitor what materials are coming on campus, and what materials (and to whom) USA is supplying. USA’s Office of Commercialization and Industry Collaboration (OCIC) manages the MTA review process and is the signatory for approval of all MTA requests. Faculty members coming to or leaving USA need to have an MTA in place prior to transferring any materials from/to other institutions such as plasmids, cell lines, animals, etc.
The Forms, Guidelines, and Procedures below provide USA researchers with USA-approved MTA forms, outline appropriate routing steps and responsible office, and the time it takes to complete the request for review and execution.
All MTA inquiries should be directed to OCIC via email at firstname.lastname@example.org.
When USA faculty are receiving materials, complete the MTA Pre-Review Questionnaire and email it along with the MTA to email@example.com.
MTA Pre-Review Questionnaire for receiving materials
If you are receiving from an Academic Institution, use the Recipient UBMTA.
If you are receiving from a company, request company’s standard MTA and email to firstname.lastname@example.org
When USA faculty are sending materials, complete the MTA Pre-Review Questionnaire and email it along with the MTA to email@example.com.
MTA Pre-Review Questionnaire for sending materials
If you are sending to an Academic Institution, use the Provider UBMTA.
If you are sending to a company, use the Commercial Entity MTA.
If you are sending any nonbiological research materials, use the Non-Biological MTA.
Material Transfer Agreement document
Typically, for incoming materials, the entity sending out the material will require the use of its own MTA form. For the purpose of outgoing material transfers, USA has standard MTA agreements on the OCIC website to cover these materials. Whether the material is incoming or outgoing, agreements of this type are negotiated by the Office of Commercialization and Industry Collaboration.
University of South Alabama is a signatory to the Uniform Biological Material Transfer Agreement (UBMTA) Master Agreement, a contracting mechanism published by NIH on behalf of PHS to facilitate the transfer of biological materials between academic institutions. As such, it is not necessary for USA to negotiate individualized terms for each transfer of a biological material. Instead, an Implementing Letter is executed, which denotes the biological material as well as the providing institution and receiving institution. Whenever possible, the UBMTA will be utilized to expedite the transfer of applicable biological materials
Incoming Material Transfer Agreement, i.e. receiving material
An incoming MTA protects a researcher's ability to use and publish research, any existing and potential intellectual property and define the use of any accompanying confidential information. The review of an incoming MTA ensures the agreement terms don't conflict with rights granted in other agreements associated with the research.
Outgoing Material Transfer Agreement, i.e. sending material
MTAs for outgoing material typically prevent the material provider from losing control over the material and its research use. If no agreement exists, then the recipient of the material has no legal restrictions on the use of the material, or on transferring the material.
Compliance Review via Pre-Review Questionnaire
MTAs (incoming/receiving and outgoing/sending) must undergo a compliance review to ensure that the appropriate compliance protocols are in place for:
- Live animals - Institutional Animal Care and Use Committee (IACUC).
- Human tissue and/or data - Compliance with 45 CFR 46 (and all other applicable federal regulations), and, if required, have protocol(s) reviewed and approved by the Institutional Review Board (IRB).
- Hazardous materials - Biosafety compliance and, if applicable, have protocol(s) reviewed and approved by the Institutional Biosafety Committee (IBC).
- Conflict of Interest (COI) – Review needed where the decision to undertake the research is based on receiving access to the material(s) from a non-governmental or industrial provider must follow Committee requirements for financial disclosure.
Sending/receiving live (vertebrate) animals
All animal orders are processed through USA Research Compliance and Assurance (RCA) and require an approved IACUC protocol. The IACUC review will determine if an MTA is needed. As a general rule:
- MTAs are needed for:
- Sending/receiving animals by incoming and outgoing Faculty (transfer of animals)
- Sending/receiving animals from/to collaborators or other institutions (unless as part of a subaward and already covered in the terms of the agreement)
- MTAs are typically not needed when:
- The PI has contracted with a vendor to generate a new animal model. Please check with the IACUC office before executing the contract as there are some requirements set by OLAW when using PHS funds for these services.
RCA will reach out to the PI for any clarifications and if an MTA is needed and there is not one already on file. The PI can also initiate this process by as instructed on the Research Compliance & Assurance webpage.
Ordering Materials from a Repository, e.g. NIH AIDS Reagent Program
Some repositories require registrations and some require MTAs, and some require both. If you are registering to use a repository, or if you are ordering a specific material, and the repository requires an institutional signature, then documentation will need to be submitted to the Office of Commercialization and Industry Collaboration. Email registration documentation to firstname.lastname@example.org.
Transferring Export Controlled Material
Export Administration Regulations (EAR). These regulations are implemented by the Bureau of Industry and Security (BIS) within the Department of Commerce. The EAR regulates the export of dual-use goods and services (goods and services having both military and civilian uses) that are identified on the Commerce Control List (CCL). These are items that are not inherently military in nature; they are primarily commercial items with potential military uses. The Department of Commerce must issue an export license, or provide an exception to or exclusion from license requirements before any controlled item, software, or information on the CCL may be exported or re-exported. There are civil and criminal penalties for violating the Export Administration Regulations.
Upon receipt of a completed MTA Pre-Review Questionnaire, OCIC will conduct a “Restricted Party Screening”, to ensure USA is not engaging with an export restricted party and notify the USA Office of Research Compliance & Assurance as appropriate.
|Steps||Responsible Office or Person||Timeline|
|Email a completed MTA Pre-Review Questionnaire and the MTA to email@example.com. Include the other organization’s contact person information||Sending/Receiving Scientist|
|Initiate MTA Pre-Questionnaire and MTA review, conduct “Restricted Party Screening” search and route to the appropriate research compliance officer, if applicable.||Office of Commercialization and Industry Collaboration (OCIC)||2-5 business days|
|If applicable, compliance review and approve for Human Subjects, Animals, Conflicts of Interest||Office of Research Compliance and Assurance (RCA)||
5-7 business days(both compliance checks done in parallel)
|Review and negotiate the terms and condition of the agreement as needed.||OCIC and RCA||5-7 business days for standard agreements and UBMTA. Non-standard agreements may take up to 15-30 days to negotiate.|
|When it is the other party’s agreement, OCIC will review the proposed MTA. Upon approval, USA and the PI signs first, returns the signed agreement to the other party, follow-up for executed agreement and close the log||OCIC||5-7 days of receipt of proposed agreement|