1. Introduction to the Offices of Biotechnology & Business Development John L. Harb Director, Office of Biotechnology __________________________________ October 30, 2008

2. Our Offices The Office of Biotechnology serves as the technology transfer office of the College. The office facilitates licensing of College technology to industry and research collaborations between industry and faculty. The Office of Business Development is focused on capturing and/or developing novel or more aggressive technology transfer opportunities.

3. “Technology Transfer” Definition Definition “Technology transfer is the process of transferring scientific findings from one organization to another for the purpose of further development and commercialization.” “Technology transfer is the process of transferring scientific findings from one organization to another for the purpose of further development and commercialization.” – Association of University Technology Managers – Association of University Technology Managers Origin of Field Origin of Field Bayh-Dole Act 1980 Bayh-Dole Act 1980 Encourages universities to patent and license the results of federally-funded research Encourages universities to patent and license the results of federally-funded research Universities have rights in intellectual property that resulted from federal research funding Universities have rights in intellectual property that resulted from federal research funding Commercialization of inventions benefit the public good Commercialization of inventions benefit the public good Royalties are distributed to inventor and reinvested for education and research purposes Royalties are distributed to inventor and reinvested for education and research purposes

4. University Technology Transfer Knowledge Transfer Knowledge Transfer Publications & Presentations Publications & Presentations Collaborations Collaborations Material Transfers Material Transfers Sponsored Research Sponsored Research Consulting Consulting Inventions Inventions Licensing Licensing

5. Your Responsibilities Acceptance Agreement Acceptance Agreement Abide by Einstein’s Patent Policy Abide by Einstein’s Patent Policy Promptly disclose inventions Promptly disclose inventions Assign ownership rights Assign ownership rights Third-Party Agreement Obligations Third-Party Agreement Obligations Publications Publications Use of Material Use of Material Confidentiality Confidentiality Reporting Reporting

6. Our Responsibilities Support Einstein faculty researchers Support Einstein faculty researchers Facilitate technology transfer relationships Facilitate technology transfer relationships Protect the school and its faculty members Protect the school and its faculty members Comply with obligations to sponsors and licensing partners Comply with obligations to sponsors and licensing partners

7. Services Invention Disclosures Invention Disclosures Patent Management Patent Management Licensing Licensing Material Transfer Agreements Material Transfer Agreements Agent Reagent Program Agent Reagent Program Industry-Sponsored Research Agreements Industry-Sponsored Research Agreements Grant required IP management language Grant required IP management language Resources and data sharing plans Resources and data sharing plans Consulting Agreements Consulting Agreements

8. Services (cont’d) Confidentiality Agreements Confidentiality Agreements Inter-Institutional Agreements Inter-Institutional Agreements Review IP language Review IP language Clinical Trial Agreements Clinical Trial Agreements Foundation/Non-Profit Grants Foundation/Non-Profit Grants

9. Invention Process Invention Disclosure Form Invention Disclosure Form Details of invention and its reduction to practice Details of invention and its reduction to practice Funding & material sources Funding & material sources Upcoming publications Upcoming publications Commercial contacts Commercial contacts Patent Committee Patent Committee Intellectual Property Protection Intellectual Property Protection

10. Licensing Process Market, market, market Market, market, market Business discussions with commercialization partners Business discussions with commercialization partners Confidentiality Agreement Confidentiality Agreement Terms Terms License Agreement License Agreement Royalty is distributed in accordance with Einstein’s Official Policy on Patents and Licensing Agreements (“Patent Policy”) Royalty is distributed in accordance with Einstein’s Official Policy on Patents and Licensing Agreements (“Patent Policy”)

11. Patent Policy Distribution Net Royalty is distributed as follows: Net Royalty is distributed as follows: 1/3 – Inventors (personally) 1/3 – Inventors (personally) 1/3 – Laboratory Research 1/3 – Laboratory Research 1/3 – College 1/3 – College

12. Material Transfer Process Various forms Various forms Incoming vs. Outgoing Incoming vs. Outgoing Academic vs. Industry Partners Academic vs. Industry Partners Human material? Human material? Hazardous material? Hazardous material? mta@aecom.yu.edumta@aecom.yu.edu & mta@aecom.yu.edu reagents@aecom.yu.edu

13. Research Tools Disclose! Disclose! Online, interactive form Online, interactive form Review for commercial value Review for commercial value Market to companies (“Agent Reagent”) Market to companies (“Agent Reagent”) High volume transfers  repositories (mice, plasmids, etc.) High volume transfers  repositories (mice, plasmids, etc.)

14. Industry-Sponsored Research PI Role Develop Research Plan Develop Research Plan Develop Budget Develop Budget Office Role Review Budget Negotiate Agreement Points to remember: Overhead policy is consistent with NIH rate Overhead policy is consistent with NIH rate Involve us in the process early on Involve us in the process early on Keep science and business separate Keep science and business separate

15. Hot Topics in Agreements Publication Rights Publication Rights Liability Liability Intellectual Property Rights Intellectual Property Rights Confidentiality Confidentiality

16. Consulting Private Agreements Private Agreements Must be approved by: Must be approved by: Department Chair Department Chair Dean (Office of Biotechnology) Dean (Office of Biotechnology) Proposed guidelines and suggested language Proposed guidelines and suggested language Not in place of outside counsel Not in place of outside counsel Clauses of concern Clauses of concern Conflicts Conflicts Prior rights & Einstein rights Prior rights & Einstein rights Time commitments Time commitments Liability Liability Distinction from research activities Distinction from research activities Student involvement Student involvement

17. Office of Biotechnology Staff John Harb, M.S.P.H. Director Assistant Dean, Scientific Operations David Schoenhaut, Ph.D. Assistant Director Benjamin Neymotin, M.A. Contracts and Licensing Associate

18. Office of Business Development Staff Richard Kosman, Sc.M.M. Director David Silva, Ph.D. Senior Business Development Analyst Janis Peck, M.B.A. Business Development Analyst

19. Contact Us Website: www.aecom.yu.edu/biotechnology Website: www.aecom.yu.edu/biotechnology Forms & Policies Forms & Policies News & Publications News & Publications Contact Information Contact Information Phone: 718-430-3357 Phone: 718-430-3357 Office: Belfer Building, 9 th Floor Office: Belfer Building, 9 th Floor

20. Want to learn more about IP? Join us… Tuesday, December 9 th Same Room Different time - Noon Guest Speaker - Kenneth P. George, Partner Amster, Rothstein & Ebenstein LLP (intellectual property law firm) “Intellectual Property Overview for the Academic Researcher”

21. Thank You Any Questions?