Material Transfer and Confidentiality Agreements

1. Material Transfer and Confidentiality Agreements February 25, 2014 SERIES 4, SESSION 2 OF AAPLS APPLICANTS & ADMINISTRATORS PREAWARD LUNCHEON SERIES

2. Introducing OTL&IC – Tufts Tech Transfer • Office for Technology Licensing and Industry Collaboration – Tech Transfer (Techtransfer.tufts.edu) • Tech Transfer is part of the Office of the Vice Provost for Research • Guest speaker – Nina Green, Director x60360 or nina.green@tufts.edu

3. Tufts Tech Transfer Mission Catalyze the transfer of Tufts technologies for global public benefit Protect Tufts innovations to enhance their value in the marketplace Foster innovation by generating an income stream that supports research at Tufts Track record of productivity and high performance statistics

4. Business Development Activities Start-up efforts (15%) Market outreach (20%) Research agreements (25%) Inventor outreach/IP management (30%) Licensenegotiations (10%)

5. Tufts Tech Transfer • Tufts Tech Transfer has an established track record of intellectual property licensing and start-up company formation • During FY2003-2012 Tufts Tech Transfer executed approximately 185 licenses/option agreements • Majority of these agreements are with small enterprises and start-up companies • Twenty-Four start-up companies established during this time • Start-up companies are a crucial component of the innovation ecosystem

6. Commercialization Process Triage & prior art analysis Market Analysis Invention disclosure form submitted Decide Strategy Market to company Market to existing company Hold for more research or give invention back to PI Market to start-up

7. Tufts Technologies & Start-ups • Pharmaceuticals • Screening Arrays • Biomaterials

8. Material Transfer Agreements (MTAs) • The transfer of materials is an important component of today’s research in the biological sciences • Biological materials can be patented and licensed for commercial purposes • More frequently Tufts Tech Transfer will license biological materials (cell lines, enzymes, vectors, etc.) for commercial purposes without patent protection • Tufts Tech Transfer can assist investigators who wish to transfer or receive materials from academic or industry colleagues

9. Academic MTAs Outgoing Materials • Tufts Tech Transfer encourages investigators to use the NIH-recommended simple letter agreement to cover the transfer of unpatented Tufts materials to academic/non-profit labs • Tufts Tech Transfer does not sign the simple letter agreement and need not be involved in these transfers • A simple letter agreement may not be appropriate if: • The materials were developed using materials or funds provided by a for-profit institution • The materials are patented or are licensed to a commercial entity Incoming Materials • All material transfer agreements covering materials to be received by Tufts investigators must be reviewed and signed by OTL&IC to ensure that the provisions contained are consistent with the university’s policies

10. Industry MTAs Outgoing Materials • Companies interested in receiving materials are required to obtain a license from the university • Investigators should notify Tufts Tech Transfer of any companies requesting their materials so that Tufts Tech Transfer may negotiate appropriate licensing arrangements Incoming Materials • Tufts Tech Transfer must review (and usually negotiate) all MTAs for materials provided by for-profit groups • Many of these MTAs contain intellectual property provisions that could be onerous to the recipient or are inconsistent with federal or University policies

11. Key MTA Provisions • Definition of Material and Ownership • Provider maintains ownership of original material, recipient owns modifications and derivatives • Provider may be granted first right to an option agreement for any new inventions resulting from use of the material • Publication Requirements • Maximum of 90 days (30 preferred) for provider to review any pending publications involving the material • Provider should only be included as an author if there has been true collaboration

12. MTA Decision Tree Simple Letter Agreement may be used; no need for Tech Transfer involvement Incoming Outgoing Commercial recipient? Agreement from provider institution; Tech Transfer reviews No Yes No Contains patented material? Existing license? Yes No No Yes Developed w/ commercial resources? Yes Contact Tech Transfer

13. Confidential Disclosure Agreement • A Confidential Disclosure Agreement (CDA) is a contract between a party who is disclosing confidential information and another party who is receiving that information • The CDA specifies the receiving party will protect and use the information. • Need for Confidential Disclosure Agreement: • Alerts the receiving party to the confidentiality of the information to be received • Specifies the responsibilities required of the receiving party • Can be used as evidence in subsequent patent processing

14. Key CDA Provisions • Direction of information flow • Is the CDA one-way or mutual? • Term and expiration • Typical CDAs requires information be maintained in confidence for 5 years • Longer or shorter terms may present concerns

15. Tech Transfer Contact Info for Agreements • Material Transfer Simple Letter Agreement • http://techtransfer.tufts.edu/wp-content/uploads/2012/11/Simple_Letter_Agreement.doc • Lee Tien, Ph.D., Licensing Associate • lee.tien@tufts.edu • mta@tufts.edu