51�鱨վ

What is an MTA

Material Transfer Agreements (MTAs) are contractual documents used for the acquisition by 51�鱨վ 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, 51�鱨վ 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 51�鱨վ's Vice President of Research (or his/her designee in the Office of Research) signs the MTA, the 51�鱨վ researcher and his or her lab is obligated to follow the terms of the MTA.

51�鱨վ is a state-supported entity that receives a large proportion of its research funding from the U.S. federal government. For example, 51�鱨վ 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 51�鱨վ 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 51�鱨վ’s Office of Research.

2. Outgoing MTAs

An agreement that governs the transfer of research material from 51�鱨վ to outside researchers. Depending on the material, the 51�鱨վ researcher may need to check in advance with 51�鱨վ’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 51�鱨վ.

When would you need an MTA?

In an incoming situation, a vendor supplying materials to 51�鱨վ requests an MTA, the 51�鱨վ researcher must initiate an MTA through 51�鱨վ's Office of Research. However, if a vendor supplying the materials to 51�鱨վ does not request an MTA, then 51�鱨վ does not request an MTA nor require an MTA. For outgoing situations (51�鱨վ researcher will be supplying material to a third party outside of 51�鱨վ), the 51�鱨վ researcher must initiate an MTA through 51�鱨վ's Office of Research.

Uniform Biological Material Transfer Agreement

51�鱨վ 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, 51�鱨վ'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, 51�鱨վ encourages its researchers to consider depositing 51�鱨վ-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 51�鱨վ?

Academic Freedom and Publication

51�鱨վ has an obligation to preserve research freedom, safeguard appropriate authorship, and ensure timely disclosure of 51�鱨վ 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 Is”

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 51�鱨վ investigator from the material, the 51�鱨վ 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. 51�鱨վ does not assign intellectual property rights to an external provider of material for novel, non-obvious and useful products that are created by an 51�鱨վ 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 51�鱨վ, 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 51�鱨վ-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).