1. Office of Research Services Update on Material Transfer Agreements

2. Office of Research Services Introduction

3. Office of Research Services Material Transfer Agreement Team

4. Matt Merz Laurance Guido Kerry Wilson Ed Pieters Katya Wickersham Alice Cao

5. Characteristics of Research Materials • Necessary • Cannot be purchased • Valuable • Cannot be used in humans

6. Materials • Reagents

7. Materials • Chemical compounds

8. Materials • Biological materials such as cell lines, plasmids, vectors, etc.

9. Penn Policy for Material Transfer Agreements • To protect researchers and Penn, whenever research materials are transferred into or out of Penn, a MTA must be completed

10. Material Transfer Agreement • Contractual document used for the acquisition of various biological and research materials, and occasionally data that are not available via retail channels • Typically, there is no payment for materials other than costs • Does not involve funding • /

11. Approval of Material Transfer Agreements • The Office of Research Services reviews MTAs to ensure that researchers and Penn are protected • Signatures • Authorized ORS signature • Principal Investigator

12. Issues with Research Materials • Intellectual property rights to modifications, new uses or inventions related to the material • Use restrictions • Publication of results • Indemnification • Governing law

13. Special Considerations • Human tissue • Export • Stem cells

14. 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 interested in collecting samples. In the past, disposal of tissue samples was routine.

15. 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.

16. MTAs and Export Controls • Any MTA that has an international component may be subject to Export Control Laws • “International Component” is defined as research that involves foreign entities, researchers or students and/or research that involves sharing of information with persons who are not US citizens or permanent residents • MTAs are reviewed for this, particularly for materials going outside the US

17. Stem Cells • All requests to conduct research or to possess human embryonic stem cells (NIH and/or non-NIH approved lines) on Penn’s campus must be evaluated and approved by the Office of the Vice Provost for Research and the OGC. The process is coordinated and ultimately processed by ORS as a MTA.

18. Communication • Notify PI that the request was received and the review process started and provide the name of the assigned negotiator • The ORS Penn negotiator will copy the PI on communications with the outside party so that the PI may understand the negotiation status

19. Completion of Transfer Agreements

20. Looking Ahead • Master Agreements • Non-negotiable Agreements • Web-based MTA requests • Electronic execution

21. Resources for Material Transfer Help • Before negotiator is assigned, contact 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@exchange.upenn.edu • After negotiator is assigned, contact assigned negotiator

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