1. Office of Research Services New Developments at Penn for Material Transfer Agreements

2. Office of Research Services Introduction

3. Office of Research Services Material Transfer Agreement Team

4. Ed Pieters Don Deyo Matt Merz Laurance Guido Kerry Wilson

5. Materials • Reagents • Chemical compounds • Biological materials such as cell lines, plasmids, vectors, etc. • Some types of software • http://www.upenn.edu/researchservices/

6. Characteristics of Research Materials • Necessary • Cannot be purchased • Valuable • http://www.upenn.edu/researchservices/

7. Issues with Research Materials • Intellectual property rights to modifications, new uses or inventions related to the material • Restrictions • Publication of results • Indemnification • http://www.upenn.edu/researchservices/

8. Material Transfer Agreement • Material Transfer Agreements (MTAs) are contractual documents used for the acquisition of various biological and research materials, and occasionally data, developed by non-profit, government and for-profit organizations. • http://www.upenn.edu/researchservices/

9. Penn Policy for Material Transfer Agreements • Whenever research materials are transferred into or out of Penn, a “Material Transfer Agreement” (MTA) must be completed and signed by an authorized ORS Penn representative, as well as the Penn researcher • http://www.upenn.edu/researchservices/

10. Approval of Material Transfer Agreements • The Office of Research Servicescannot sign a MTA without review • Signatures • Authorized ORS signature • Principal Investigator • http://www.upenn.edu/researchservices/

11. Completion of Transfer Agreements • Presently ~ 28 days • Goal – reduce to 14 days • http://www.upenn.edu/researchservices/

12. Communication • The ORS Penn negotiator will copy the PI in the initial negotiation email • http://www.upenn.edu/researchservices/

13. Resources for Material Transfer Help • Matthew Merz, MTA Administrator University of Pennsylvania Office of Research Services Franklin Building, Room P221 3451 Walnut Street Philadelphia, PA 19104-6205 Phone: (215) 573-4505 Fax: (215) 898-9707 Email: ORSMTA@upenn.edu http://www.upenn.edu/researchservices/

14. Resources for Material Transfer Help • PennERA Website

15. Resources for Material Transfer Help • MTA Web Site http://www.upenn.edu/researchservices/materialtransfer/ http://www.upenn.edu/researchservices

16. Special Material Transfer Agreements • Human tissue • Export • Stem cells • http://www.upenn.edu/researchservices/

17. Human Tissue? • Hospitals, medical schools, drug companies hold millions of samples of human blood, tumors, skin, hearts, kidneys, livers, placenta, embryos, etc. • Samples might come from potentially cancerous tumors, organs removed during surgery, or even hair and nail clippings. • Samples in Tissue Banks • Hospitals, medical schools and pharmaceutical houses are racing to collect them. In the past, disposable of tissue samples was routine.

18. Human Tissue = Human Subject Research • Transfer and use of Human Tissues is research involving human subjects and may be subject to the IRB common rule. • HIPAA: the privacy of individually identifiable health information is protected for the establishment of conditions of its use and disclosure.

19. MTAs and Export Controls • Export Control Regulations may apply to some materials covered by MTA • Examples: materials usable in biological / chemical weapons (pathogens and toxins) • MTAs are reviewed for this, particularly for materials going outside the US