MTAs: An Overview

1. MTAs: An Overview Lakita Cavin, J.D., Ph.D. Staff Attorney University of Tennessee Research Foundation

2. What is an MTA? Most material exchanges require MTA that must have an institutional signature. • Contract • Any exchange of promises is a contract • License agreement • Confidentiality agreement • Agreement on intellectual property rights • Agreement on liability

3. Why do I need an MTA? • Especially needed when proprietary information involved • For material coming IN, an MTA is required if the provider requires it. • For material going OUT, consult with the ORA and/or UTRF • Material is infectious or hazardous • Can resolves issues: liability, academic credit, loss of control of the material, disagreements.

4. What is a UBMTA • Uniform Biological Materials Transfer Agreement developed in 1995 for transfer of biological materials between non-profit entities. • Useful for simple agreements • Between signatory institutions • Not all academic institutions are signatories, and no industry providers are. • If the material is proprietary, use of the UBMTA may not be appropriate. No IP issues • “Non-commercial”, “not-for-profit”, “research purposes only” • In other words: No patentable invention existing or expected

5. Are MTA agreements ever enforced? • In most cases, no need to enforce. • If a dispute arises, MTA may be subject of litigation. • MTA can assist in adjudicating the dispute.

6. Submitting an MTA: Preliminary Matters • Certification form • Route Sheet • Questionnaire (helps us to assess project, purpose of material, and how to negotiate) • Forms available at http://www.utmem.edu/research/research_admin/index.php?doc=forms.htm • Submit to Office of Research (910 Madison Ste. 823) • Biosafety Approval (Francine Rogers)

9. Why is all this necessary? • MTAs usually are related to material to be used in sponsored research. • Terms of the MTA may conflict with terms of the grant or contract under which the research is funded. • Materials may be requested from multiple providers for the same project that may be funded by multiple sources. • Material may be hazardous

10. The Approval Process General Counsel Biosafety Office Research Office Other Institution UTRF Third Party Researcher

11. Why does the process take so long? • Office of Research submits to UTRF for review. • Determine who needs to be party. • UT, Provider, maybe UTRF. Not PI. • Check to see if provider is signatory to UBMTA. • Contact provider • Request e-version • Notify that you will need to modify • Review/Make changes. • Submit to Office of Research for Approval • Submit to provider for approval(Negotiate). • May not respond right away. Have to follow up. • May take some time • May not ever happen. • If Provider approves, notify Office of Research that other party agrees to changes. • Submit for signatures. • Foreign MTAs have to be approved by General Counsel (Knoxville) • Send signed copies to Provider.

12. Important Factors • NIH Guidelines/Funding Agreements • Journal Requirements • UT policy and state law

13. NIH Guidelines for Sharing Biomedical Research Resources Bayh-Dole In 1980, the Bayh-Dole Act (PL 96-517, Patent and Trademark Act Amendments of 1980) created a uniform patent policy among the many federal agencies funding research. As a result of this law, universities retain ownership to inventions made under federally funded research. • Under the Bayh-Dole Act and its implementing regulations, agreements to acquire materials for use in NIH-funded projects cannot require that title to resulting inventions be assigned to the provider. • For this reason, definitions of “material” that includeall derivatives or modifications are unacceptable. Other unacceptable variations include improvements, or any other materials that could have not been made without the provided material. • unacceptable. • Promote utilization, commercialization and public availability of inventions.

14. Authors must make UNIQUE MATERIALS (e.g., cloned DNAs; antibodies; bacterial, animal, or plant cells; viruses; and computer programs) promptly available on request by qualified researchers for their own use. (PNAS) Each author should have participated sufficiently in the work to take responsibility for appropriate portions of the content. (JAMA) Journal Requirement

15. Potential Issues • Problem provisions • Definition of Material • modifications • derivatives • Limit to original materials, progeny, unmodified derivatives • If modifications and derivatives included, Provider would own results and prevent PI from using own results • Intellectual Property • Ownership, control, and management • Can conflict with funding agreements and prevent future use and licensing of technology • Publication Restrictions (manuscript, abstract, presentation) • Provider requests review to determine if patentable inventions (Can cause publication delays ) • Provider requests written consent to publish • Provider requests coauthorship • Violates academic freedom, conflict with funding agreement and journal requirements • Conflicts with existing agreements. • Use with other compounds under another MTA. Could result in granting both parties conflicting rights to invention. We have to know if material will be used with other compounds and review that MTA. • Permission from 3rd party • Notify provider of 3rd party mta • Could present IP problems • Inventorship determined later

16. Potential Issues • Biggest Issues • Indemnification/Liability (financial responsibility) • Prohibited • UT is an agency of the State of Tennessee and cannot indemnify or hold harmless. (TCA 9-8-301 et seq.) (violate the Constitution of the State of Tennessee) • UT can agree to be responsible for its actions and those of its employees to the extent allowed by law. • Frivolous lawsuits can happen • Choice of law (governing law), jurisdiction. • Request to remain silent on law. • Illegal aliens • Prohibits entering into contract for goods or services with any person who knowingly uses services of illegal immigrants

17. Post-Approval • Signed copies sent to Provider • Provider sends material, hopefully. • Follow-up if necessary.

18. Additional Notes Remember • MTA required when materials come in or go out. • You should NOT be signing MTA as a party. • Try to make sure you can obtain material before submitting grant.

19. How long will this take? • Less time than it took in the past. • I am the central contact point for negotiations between UT and the other party.

20. Improvements • Faster process • More communication • Provide information on the approval process • Provide information on status of pending MTA • Listen to your concerns

21. Resources on MTAs • AUTM Educational Series: Material Transfer Agreements • Berkeley Quick Guide to MTAs: www.spo.berkeley.edu/guide/mtaquick.html • COGR booklet: www.cogr.edu.docs/MaterialsTransfer.pdf • FDA chart: www.fda.gov/oc/ofacs/partnership/techtran/criteria.htm • UT contract terms: http://www.utmem.edu/research/clinical_study/contract_term.pdf

22. Resources (cont’d) • Journal of the American Medical Association (JAMA) Manuscript Criteria and Information: http://jama.ama-assn.org/ifora_current.dtl • NIH Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: http://ott.od.nih.gov/NewPages/RTguide_final.html • Proceedings of the National Academy of Sciences – Information for Authors: http://www.pnas.org/misc/iforc.shtml

23. Contact Info • Lakita Cavin, J.D., Ph.D.(UTRF, Memphis) • 920 Madison Ave., Ste. 515 (901) 448-7825 lcavin@utmem.edu • Van Irion, J.D. (UTRF, Knoxville) • 1534 White Ave., Ste. 403 (865) 974-9559 virion@utk.edu • Deborah L. Smith, Ed.D.(ORA) • 910 Madison Ave., Ste. 823 (901) 448-4823 dsmith@utmem.edu • Francine Rogers(Biosafety) • 910 Madison Ave., Ste. 650 (901) 448-3537 frogers1@utmem.edu