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