1. The IOM Template Project:Material Transfer Agreements and Clinical Trial Agreements Presentation to the IOM Forum on Drug Discovery, Development and Translation April 27, 2009 Jim Snipes Covington & Burling, San Francisco jsnipes@cov.com

2. Objectives • Generate standard forms of agreement to streamline industry-university negotiations • starting-point for discussions • benchmarking tool • Template for material transfer agreement (MTA) • transfer from company to university • research not sponsored by the company • Template for clinical trial agreement (CTA) • sponsor-initiated • Phase 2 or Phase 3 • multi-center trial

3. Process • Companies and universities shared standard forms of MTA/CTA • Covington & Burling retained to review forms, prepare initial drafts of templates • Working group from academia and industry convened

4. Ground rules • Aim for the middle ground • 80% rule – target the typical transaction • Shoot for brevity and simplicity • No obligation to adopt or endorse

5. Material Transfer Agreement Template • Ownership of IP • “Inventor owns” structure • Recipient to grant Transferor broad license to use know-how nonexclusive license to use patentable inventions to exploit materials option to negotiate exclusive license under patentable inventions

6. MTA Template • Publication • Recipient may publish results of research and identifying information regarding materials • Transferor has pre-publication right of review • Publication subject to delay for filing of patent applications

7. MTA Template • Indemnification • materials provided “as is” – no indemnity from Transferor • Recipient to indemnify Transferor for losses from conduct of research or use of materials

8. Clinical Trial Agreement Template • Ownership of IP • Inventor owns, except that Sponsor owns all patentable inventions related to study drug • Sponsor to grant Institution broad research license to inventions related to study drug • Institution to grant Sponsor option to negotiate exclusive license to Institution-owned inventions developed in the trial

9. CTA Template • Ownership of data and records • Sponsor to own all case report forms, databases and study reports prepared under the protocol • Institution to own primary medical records, other source documents • restrictions on disclosure of data from study deliverables

10. CTA Template • Publication • Institution may publish summary of the study results and supporting data • Single-center publication to be deferred until publication of summary of results from all centers • Sponsor has right of pre-publication review

11. CTA Template • Indemnification/Subject Injury • Sponsor to bear medical expenses of subjects incurred in connection with the trial • Sponsor to indemnify Institution for losses from use of study drug or procedures under protocol • Institution to indemnify Sponsor for losses from failure to follow protocol or negligence

12. Comments from the Panel Diane Archer, University of California Richard Neff, Schering-Plough Adam Rifkind, University of Pennsylvania Gil Smith, Duke University