MTA Guiding Principles: Best Practices in Non-Profit to Non-Profit Transfers of Published Research Materials

These AUTM Principles apply to transfers of published materials from one non-profit research institution to another for use in research. The Principles do not apply to the use of the Material in human subjects or for clinical use.

Definition of "Material" as used below is the originally provided material plus, in the case of biological materials, progeny, unmodified subunits, or expression products, as defined in the Uniform Biological Material Transfer Agreement (UBMTA).

1. Provider should maintain ownership of Materials. This includes any Material that has been incorporated into substances generated by Recipient. Provider should not seek ownership of substances generated by Recipient unless such substances are progeny or unmodified derivatives (unmodified subunits or expression products) of the originally provided material. Use of undefined terms to establish ownership of products of Recipient’s research, such as "derivatives," should be avoided.

2. Recipient should not transfer Materials to third parties. Recipient should not be allowed to transfer the Material beyond researchers working under the direction of the Recipient PI. However, Recipient should have the right to make new substances generated by Recipient containing the Material available to other investigators in nonprofit research institutions for research purposes only, under terms no more restrictive than those found in the UBMTA.

3. Provider should make Material available to other nonprofit institutions. If Material is a unique resource Provider should commit to making Material available to other investigators for basic research under terms no more restrictive than the UBMTA to satisfy a need to reproduce published data and build upon published results. This is only to the degree that there are sufficient quantities available, and that the Material is not otherwise available commercially or easily manufactured by the requestor.

4. The Provider should not place restrictions on the funding sources the Recipient may use. If the Recipient is using the Material for its nonprofit research purposes, there should be no restrictions on the funding sources used by the Recipient. In particular, the use of funds from industry should be permitted, as long as the Material is not used for commercial purposes and the Material is not transferred to the industry sponsor. If the industry sponsor wishes to use the Material in its facilities, it should discuss terms with the Provider.

5. Other than research use rights, the Provider should have no rights to inventions made by the Recipient in the use of the Material. Consistent with the NIH Research Tools Guidelines and the Nine Points to Consider, the Provider (and all other nonprofit research institutions) should have the right to use for its own internal research and education purposes inventions made by the Recipient in the use of the Material. While the Provider can appropriately restrict the Recipient’s further transfer of the original Material provided, the Provider should place no restrictions on what the Recipient does with inventions created solely by Recipient scientists. However, Recipient should notify Provider if Recipient files a patent application claiming a method of manufacture of Material, or claiming a substance that contains the Material.

6. Recipient does not receive any commercial rights from the Provider. Recipient rights should not include the right to sell, lease, or license the Material to third parties unless otherwise authorized by the Provider. The Provider may prohibit use of the Material by the Recipient for commercially-oriented activities such as fee-for-service work.

7. Provider should not require a Statement of Work from the Recipient. For published materials, consistent with the freedom of academic research, the Provider should not require the Recipient to provide a detailed Statement of Work.

8. The Provider should not require pre-review or copies of publications. The Provider should not require a copy of any publication involving use of the Material, since such publication will be publicly available already, nor should the Provider require a pre-review period.

9. The Providing scientist should not require authorship. Provider should not require Provider scientist to be listed as an author in Recipient publications, except as scientifically appropriate, but may require that the Recipient acknowledge the source of the Material in any scientific publication. Similarly, the Provider should not require a collaboration as a condition of providing the Material.

10. There should be no requirement for Recipient to treat research results or the Material as confidential. Recipient shall not be restricted in any way from disclosing the results of its research. In addition, because the Material has been published, there should be no restriction on disclosing the composition or structure of Material. Moreover, maintaining confidentiality of information received from Provider is generally inconsistent with these open transfers of published materials for Recipient’s research that is intended to be published. However, if Provider chooses to provide unpublished information, it may ask that such information be held in confidence, pursuant to a standard confidentiality provision in which the information is transferred in writing, marked as such, and with the customary exceptions.

11. Each party should accept liability for its own actions. To the extent it is legally able to do so, Recipient should accept liability for Recipient’s use, and Provider should accept liability for losses due to Provider’s gross negligence or willful misconduct. No indemnification of Provider by Recipient should be required.

12. Provider may specify disposal of Material on termination, but Recipient should be permitted to continue research use of new substances. A termination date should be specified. Upon termination, Material should be returned or destroyed, at Provider’s direction. Destruction of Recipient’s new substances containing Material should not be required, but Recipient should be allowed to transfer such new substances to other investigators for research purposes only.

13. Provider should include export control language only if the Material is known by the Provider to be subject to export control restrictions. If the Provider is aware of any export control restrictions associated with the Material, it should provide that information to the Recipient. The parties should assist each other in complying with export control regulations.

14. Institutions, rather than individual investigators, should assume responsibility for insuring that Materials are transferred under terms consistent with these principles.

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