Transcript Presentation to the IOM Forum on Drug Discovery, Development and

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
[email protected]
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
2
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
3
Ground rules
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Aim for the middle ground
80% rule – target the typical transaction
Shoot for brevity and simplicity
No obligation to adopt or endorse
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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
5
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
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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
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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
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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
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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
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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
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Comments from the Panel
Diane Archer, University of California
Richard Neff, Schering-Plough
Adam Rifkind, University of Pennsylvania
Gil Smith, Duke University
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