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Material Transfer and Confidentiality Agreements

February 25, 2014 SERIES 4, SESSION 2 OF AAPLS APPLICANTS & ADMINISTRATORS PREAWARD LUNCHEON SERIES

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 [email protected]

Tufts Tech Transfer

Building relationships with faculty inventors

Mission

Outreach with industry partners and licensees

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

80+ cumulative years experience in technology transfer Invention triage and IP management expertise Core research support through industry sponsored agreements and MTAs

Track record of productivity and high performance statistics

Business Development Activities

Start-up efforts (15%) Market outreach (20%) Research agreements (25%) License negotiations (10%) Inventor outreach/ IP management (30%)

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

licenses/option agreements executed approximately 185  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

Commercialization Process

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

Tufts Technologies & Start-ups

 Pharmaceuticals  Screening Arrays  Biomaterials

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

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

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

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

MTA Decision Tree

Incoming Agreement from provider institution; Tech Transfer reviews Outgoing Yes Commercial recipient?

No Yes Contains patented material?

Simple Letter Agreement may be used; no need for Tech Transfer involvement Yes No Developed w/ commercial resources?

No No Existing license?

Yes Contact Tech Transfer

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

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

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   [email protected]

[email protected]