NOVEMBER 13, 2012 SERIES 2, SESSION XI OF APPLICANTS & ADMINISTRATORS PREAWARD LUNCHEON SERIES Research Sponsored by Industry – Putting an Agreement in Place

Introducing OTL&IC Office for Technology Licensing and Industry Collaboration (Techtransfer.tufts.edu) OTL&IC is part of the Office of the Vice Provost Guest speaker – Colm Lawler, Associate Director. Technologies: life science, medicine

What does OTL&IC do? Works to make Tufts inventions and discoveries available for public benefit Promotes research at Tufts by facilitating appropriate relationships between the University and industrial collaborators Manages intellectual property assets arising from Tufts research Negotiates agreements that involve intellectual property

Agreement negotiation Type of Agreements Confidentiality Agreement (CDA) Material Transfer Agreement (MTA) Collaboration Agreement Inter-Institutional Agreement (IIA) Option to License Agreement License Agreement Sponsored Research Agreement (SRA)

Confidentiality Agreement (CDA)  Covers the exchange of unpublished information between entities  Can be 1-way, 2-way, etc. Material Transfer Agreement (MTA)  Covers the exchange of specific research materials between entities. Determine what types of entities are involved  Can be 1-way, 2-way, etc.  Use Universal Biological Material Transfer Agreement (UBMTA) as much as possible as it is NIH approved

Collaboration Agreement  Covers the structuring of a research relationship between entities  No exchange of funds expected between any of the parties  Future intellectual property management, publication rights and project management are important subject matters Inter-Institutional Agreement (IIA)  Covers the management of defined intellectual property assets that are owned by more than one institution

Option to License Agreement  Covers the intent of a 3 rd party for a future license of a defined Tufts intellectual property asset  Variety of business and legal terms to be considered License Agreement  Covers the use (generally commercial) of a defined Tufts intellectual property asset by a 3 rd party  Variety of business and legal terms to be considered  Particularly important for Tufts start-up companies

Sponsored Research Agreement (SRA) SRA is a contract between Tufts and a non-federal sponsor for the purposes of funding and conducting research at Tufts OTL&IC and ORA (Office of Research Administration) work together to put in place SRAs Developing an SRA may be brief or lengthy, depending on the complexity of the program to be sponsored and what the sponsor expects to obtain for its support

Terms of SRA Scope of Work to be conducted Budget for the research Payment obligations and timing Management and staffing of the research project Schedules and deliverables Publication of the research results Options to license the IP arising from the research Care of data and confidential information Use of Tufts name Rights and procedures to terminate the project Taxes, insurance, warranties, liability, governing law, and other items necessary for contracts

Internal forms for SRA Internal forms are submitted and processed by ORA except for the Agreement on Ownership of Intellectual Property (IP) (only signed once, collected by OTL&IC) Needed: 1. Internal Sponsored Coordination Form 2. Financial Interest Disclosure Form(s) from all investigators

How to initiate SRA The party that provides funds normally sends a draft of the agreement for review Tufts is able to draft an agreement upon request of the funding party Draft is reviewed and negotiated jointly by ORA and OTL&IC It is vital to follow established work-flow process to ensure that the agreement is fully valid and legally recognized by all involved

Expediting SRA Delays are common when the terms are complex, when there are differences in approach between the parties, and when other party engages their legal department Most contentious terms: IP ownership and publication. These terms are deal breakers for Tufts You can speed up the process by providing the following in a timely fashion: internal approvals, begin and end dates of project, research plan, budget and contact information for the other party

Conclusions Engage ORA and OTL&IC as appropriate and early in the process Obtain internal approvals Provide critical pieces of information in a timely manner Be prepared that negotiations can be lengthy, particularly if the other party insists on IP ownership or restrictions on publication