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

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

3. Why do I need an MTA? Especially needed when proprietary information involved Especially needed when proprietary information involved For material coming IN, an MTA is required if the provider requires it. For material coming IN, an MTA is required if the provider requires it. For material going OUT, consult with the ORA and/or UTRF For material going OUT, consult with the ORA and/or UTRF Material is infectious or hazardous Material is infectious or hazardous Can resolves issues: liability, academic credit, loss of control of the material, disagreements. 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. Uniform Biological Materials Transfer Agreement developed in 1995 for transfer of biological materials between non-profit entities. Useful for simple agreements Useful for simple agreements Between signatory institutions Between signatory institutions Not all academic institutions are signatories, and no industry providers are. 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 If the material is proprietary, use of the UBMTA may not be appropriate. No IP issues “Non-commercial”, “not-for-profit”, “research purposes only” “Non-commercial”, “not-for-profit”, “research purposes only” In other words: No patentable invention existing or expected In other words: No patentable invention existing or expected

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

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

9. MTAs usually are related to material to be used in sponsored research. 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. 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. Materials may be requested from multiple providers for the same project that may be funded by multiple sources. Material may be hazardous Material may be hazardous Why is all this necessary?

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

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

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

13. 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 include all 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.Promote utilization, commercialization and public availability of inventions. NIH Guidelines for Sharing Biomedical Research Resources

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) 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) Each author should have participated sufficiently in the work to take responsibility for appropriate portions of the content. (JAMA) Journal Requirement

15. Problem provisions Problem provisions Definition of Material Definition of Material modifications modifications derivatives derivatives Limit to original materials, progeny, unmodified derivatives Limit to original materials, progeny, unmodified derivatives If modifications and derivatives included, Provider would own results and prevent PI from using own results If modifications and derivatives included, Provider would own results and prevent PI from using own results Intellectual Property Intellectual Property Ownership, control, and management Ownership, control, and management Can conflict with funding agreements and prevent future use and licensing of technology Can conflict with funding agreements and prevent future use and licensing of technology Publication Restrictions (manuscript, abstract, presentation) Publication Restrictions (manuscript, abstract, presentation) Provider requests review to determine if patentable inventions (Can cause publication delays ) Provider requests review to determine if patentable inventions (Can cause publication delays ) Provider requests written consent to publish Provider requests written consent to publish Provider requests coauthorship Provider requests coauthorship Violates academic freedom, conflict with funding agreement and journal requirements Violates academic freedom, conflict with funding agreement and journal requirements Conflicts with existing agreements. 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. 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 Permission from 3rd party Notify provider of 3rd party mta Notify provider of 3rd party mta Could present IP problems Could present IP problems Inventorship determined later Inventorship determined later Potential Issues

16. Biggest Issues Biggest Issues / Indemnification/Liability (financial responsibility) Prohibited TCA 9-8-301 et seq.) 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. Choice of law (governing law), jurisdiction. Request to remain silent on law. Request to remain silent on law. Illegal aliens Illegal aliens Prohibits entering into contract for goods or services with any person who knowingly uses services of illegal immigrants 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 Signed copies sent to Provider Provider sends material, hopefully. Provider sends material, hopefully. Follow-up if necessary. Follow-up if necessary.

18. Additional Notes MTA required when materials come in or go out.MTA required when materials come in or go out. You should NOT be signing MTA as a party. Remember 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. Less time than it took in the past. I am the central contact point for negotiations between UT and the other party. I am the central contact point for negotiations between UT and the other party.

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

21. Resources on MTAs AUTM Educational Series: Material Transfer Agreements AUTM Educational Series: Material Transfer Agreements Berkeley Quick Guide to MTAs: Berkeley Quick Guide to MTAs: www.spo.berkeley.edu/guide/mtaquick.h tml www.spo.berkeley.edu/guide/mtaquick.h tml COGR booklet: COGR booklet: www.cogr.edu.docs/MaterialsTransfer.p df www.cogr.edu.docs/MaterialsTransfer.p df FDA chart: www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm FDA chart: www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm www.fda.gov/oc/ofacs/partnership/techt ran/criteria.htm UT contract terms : http://www.utmem.edu/research/cli nical_study/contract_term.pdf UT contract terms : http://www.utmem.edu/research/cli nical_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 Journal of the American Medical Association (JAMA) Manuscript Criteria and Information: http://jama.ama-assn.org/ifora_current.dtl 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: 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.h tml http://ott.od.nih.gov/NewPages/RTguide_final.h tml Proceedings of the National Academy of Sciences – Information for Authors: http://www.pnas.org/misc/iforc.shtml Proceedings of the National Academy of Sciences – Information for Authors: http://www.pnas.org/misc/iforc.shtml http://www.pnas.org/misc/iforc.shtml

23. Contact Info Lakita Cavin, J.D., Ph.D.(UTRF, Memphis) Lakita Cavin, J.D., Ph.D.(UTRF, Memphis) 920 Madison Ave., Ste. 515 920 Madison Ave., Ste. 515 (901) 448-7825 (901) 448-7825 lcavin@utmem.edu Van Irion, J.D. (UTRF, Knoxville) Van Irion, J.D. (UTRF, Knoxville) 1534 White Ave., Ste. 403 1534 White Ave., Ste. 403 (865) 974-9559 virion@utk.edu Deborah L. Smith, Ed.D.(ORA) Deborah L. Smith, Ed.D.(ORA) 910 Madison Ave., Ste. 823 910 Madison Ave., Ste. 823 (901) 448-4823 (901) 448-4823 dsmith@utmem.edu Francine Rogers(Biosafety) Francine Rogers(Biosafety) 910 Madison Ave., Ste. 650 910 Madison Ave., Ste. 650 (901) 448-3537 (901) 448-3537 frogers1@utmem.edu frogers1@utmem.edufrogers1@utmem.edu