What is an MTA
Material Transfer Agreements (MTAs) are contractual documents used for the acquisition by ÒÁµéÔ°ÊÓƵ researchers of various biological and research materials developed by other universities, nonprofits, governments and private industry. Examples of these research materials include transgenic mice, cell lines, gene constructs, antibodies or chemical compounds for pre-clinical research use. Often these materials are a necessary component of a research project and are available only from a sole source, such as industry. The MTA defines the rights of the provider and the recipient with respect to the materials and any derivatives. Industry may view their materials as important proprietary resources and may want to assert ownership of any inventions made with those materials or restrict publication of unfavorable results. Through negotiation, ÒÁµéÔ°ÊÓƵ will want to ensure that MTA terms permit full dissemination of research results, and do not conflict with other university policies, including the university's nonprofit mission. When ÒÁµéÔ°ÊÓƵ's Vice President of Research (or his/her designee in the Office of Research) signs the MTA, the ÒÁµéÔ°ÊÓƵ researcher and his or her lab is obligated to follow the terms of the MTA.
ÒÁµéÔ°ÊÓƵ is a state-supported entity that receives a large proportion of its research funding from the U.S. federal government. For example, ÒÁµéÔ°ÊÓƵ will review MTAs for biological materials to ensure compliance with National Institutes of Health (NIH) policies, including the Principles and Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.
There are two types of Material Transfer Agreements:
1. Incoming MTAs
An agreement that governs the use of research materials from an outside organization by an ÒÁµéÔ°ÊÓƵ researcher. If the external party (transferor of materials) specifically requires an MTA to be in place prior to the transfer, then the incoming draft MTA must be reviewed, negotiated and executed by ÒÁµéÔ°ÊÓƵ’s Office of Research.
2. Outgoing MTAs
An agreement that governs the transfer of research material from ÒÁµéÔ°ÊÓƵ to outside researchers. Depending on the material, the ÒÁµéÔ°ÊÓƵ researcher may need to check in advance with ÒÁµéÔ°ÊÓƵ’s Office of Environmental Health & Safety to ensure safe packaging and shipping of the materials. Researchers should notify the Research Compliance group (email: arubenst@odu.edu) prior to sending out any biological materials to a third party to ensure that any applicable research compliance approvals are in place at ÒÁµéÔ°ÊÓƵ.
When would you need an MTA?
In an incoming situation, a vendor supplying materials to ÒÁµéÔ°ÊÓƵ requests an MTA, the ÒÁµéÔ°ÊÓƵ researcher must initiate an MTA through ÒÁµéÔ°ÊÓƵ's Office of Research. However, if a vendor supplying the materials to ÒÁµéÔ°ÊÓƵ does not request an MTA, then ÒÁµéÔ°ÊÓƵ does not request an MTA nor require an MTA. For outgoing situations (ÒÁµéÔ°ÊÓƵ researcher will be supplying material to a third party outside of ÒÁµéÔ°ÊÓƵ), the ÒÁµéÔ°ÊÓƵ researcher must initiate an MTA through ÒÁµéÔ°ÊÓƵ's Office of Research.
Uniform Biological Material Transfer Agreement
ÒÁµéÔ°ÊÓƵ is a signatory to the Uniform Biological Material Transfer Agreement (UBMTA) Master Agreement, a contracting mechanism published by NIH to facilitate the transfer of biological material between academic institutions. For institutions who have agreed to the terms of the UBMTA Master Agreement, it is not necessary to negotiate individualized terms for each transfer of a biological material. An Implementing Letter is executed, instead, which identifies the biological material, as well as the providing institution and receiving institution. Whenever possible, ÒÁµéÔ°ÊÓƵ's Office of Research will utilize the UBMTA to expedite the transfer of applicable biological materials.
Repository Deposits
To facilitate broader access to research resources, ÒÁµéÔ°ÊÓƵ encourages its researchers to consider depositing ÒÁµéÔ°ÊÓƵ-owned research tools into nonprofit repositories or biological resource centers (BRCs) to further distribute them to the scientific community. Select examples of nonprofit repositories include Addgene, American Type Culture Collection (ATCC), and Coriell Institute for Medical Research. Researchers who identify a nonprofit repository of interest that will accept the materials can initiate an outgoing MTA with an .
What are selected principles and practices of MTAs at ÒÁµéÔ°ÊÓƵ?
Academic Freedom and Publication
ÒÁµéÔ°ÊÓƵ has an obligation to preserve research freedom, safeguard appropriate authorship, and ensure timely disclosure of ÒÁµéÔ°ÊÓƵ scientists' research findings through publications and presentations at scientific meetings. Excessive publication delays (to enable other party to review publication draft for possible disclosure of confidential information), requirements for editorial control, approval of publications, or withholding of data undermine the credibility of research results and are unacceptable.
Definition of Material
MTAs should adequately define with specificity the material that that is being transferred so that there will not be a dispute later over what material was covered under the terms of the MTA.
Taking material “As Isâ€
Material is experimental and may have hazardous properties. Except to the extent prohibited by law (e.g. gross negligence or willful misconduct by the Provider), Recipient typically assumes all liability for damages which may arise from material's use, storage or disposal. No representations or warranties of the material are given by the Provider.
Ownership of intellectual property by a material provider
If an MTA states that the material provider will own any resulting intellectual property generated by the ÒÁµéÔ°ÊÓƵ investigator from the material, the ÒÁµéÔ°ÊÓƵ investigator may be restricted in his/her ability to interact with a future sponsor, may have obligations to current sponsors, may be prohibited from publishing and may be unable to use the research results in future research. ÒÁµéÔ°ÊÓƵ does not assign intellectual property rights to an external provider of material for novel, non-obvious and useful products that are created by an ÒÁµéÔ°ÊÓƵ researcher from research work that is done with the provided material.
Use of materials in sponsored research projects
Some industry MTAs contain language that prohibit the use of material in research that is subject to licensing or consulting obligations to any third party, including the sponsor of the research project. In that case, researchers will need to identify what funds will be used to support the project if no external funds, including NIH funds, may be used to support the project.
How do you initiate an MTA?
If you are a researcher at ÒÁµéÔ°ÊÓƵ, submit an , along with an attachment of any draft agreement provided by the other party. If the other party has not provided a draft agreement, the Office of Research has a template of an ÒÁµéÔ°ÊÓƵ-approved MTA that can be used to initiate discussions with the other party. Note: ensure any necessary protocols have been approved by the university prior to submitting an Unfunded Agreement Request form (see answer to question #1 under FAQs section).
Frequently Asked Questions (FAQs) about MTAs
- If human subject research is federally supported, there must be a protocol approved by the Institutional Review Board (College Committee if non-federally supported) before an MTA can be executed.
- If research uses recombinant-DNA, Biohazards and Bloodborne Pathogens, there must be a protocol approved by the Institutional Biosafety Committee before an MTA can be executed.
- If animal research is involved, there must be a protocol approved by the Institutional Animal Care and Use Committee (IACUC) before an MTA can be executed.
Do not distribute the material. Simply refer the individual to the Provider. Oftentimes the agreement states that the Provider agrees to make material available, under similar terms, to other scientists (at least at nonprofits) who wish to replicate Recipient Scientist's research and will reimburse preparation and distribution costs.
Provider typically retains ownership of the material, including any material contained or incorporated in modifications.
Recipient typically will discontinue using the Material, and will, upon direction of the Provider, return or destroy any remaining material.
Yes, it is good scientific citizenship to acknowledge the source of critical materials in publications. In fact, many MTAs explicitly require the source of the material to be acknowledged in publications.
No, unless the Recipient in advance of such use negotiates with the Provider to establish the terms of a commercial license.
No, you would need to submit a request for a Data Use Agreement (DUA) to ÒÁµéÔ°ÊÓƵ's Research Compliance group by email to: ARubenst@odu.edu
The Agreement Compliance Manager will distribute via email the executed MTA to the ÒÁµéÔ°ÊÓƵ Principal Investigator.
Only the Vice President of Research (or his/her designee in the Office of Research) is authorized to sign an MTA to obligate ÒÁµéÔ°ÊÓƵ. Some MTAs will have additional signature lines for both the provider scientist and the recipient scientist. If Principal Investigators or lab personnel exclusively sign an MTA from ÒÁµéÔ°ÊÓƵ, they could be held personally liable for a lawsuit that results from the transfer of materials.
