Transcript Document
Statutory and Regulatory
Language in Agreements
STEFANI SHEK, STANFORD UNIVERSITY
IDA SHUM, LAWRENCE LIVERMORE NATIONAL LABORATORY
Statutory & Regulatory
Statutory – requirement by the law enacted by a
state or federal legislative body
Regulatory – rule or standard adopted by an
administrative agency or department empowered by
the law to issue such rules or standards. These
bodies also have the authority to enforce the law
Issues
Impact of Language
More frequent
More complex
More pressure to accept it
Difficult to understand it
Difficult to comply with it
Lack of guidance and precedent
What should we do?
Denial
Waiver
Acceptance
Statutory/Regulatory Language
Licenses, Cooperative Research and Development
Agreements (CRADA) aka Sponsored Research
Agreements (SRA)
March-in Rights
United States Preference (aka “substantial manufacture” in the
US)
Export Control
Material Transfer Agreements
Regulatory Clauses
FAR (DEAR, DFAR, HHSAR, etc.)
Examples
Anti-kickback/Fair Market
The parties acknowledge that any funding has been
determined with reference to the fair market value of the costs
associated with the research and not in a manner that takes
into account the volume or value of any referrals or business.
Sunshine Act
Reporting salaries by hourly rates
Regulatory Terms in Human Sample Material Transfer
Agreements
Thierry Musy-Verdel
Genentech, Research Contracts
August 15, 2012
© 2010 Genentech, Inc.
PRIVILEGED AND CONFIDENTIAL
Human Sample MTAs
Page 7
• Representation and Warranties of:
(a) Institutional review board review and approval;
(b) Appropriate informed consent of all human subjects; and
(c) Samples obtained in compliance with all applicable law, i.e.
HIPAA in US.
• Genentech requires indemnity from the Institution.
• Furthermore, Genentech requires that all samples provided by
Institution are to be de-identified and free from any Protected
Health Information (PHI) as defined under HIPAA.
© 2010 Genentech, Inc.
PRIVILEGED AND CONFIDENTIAL
Discussion
What should we do?
Denial
Waiver
Acceptance
What do you do?
Contact Information
Thank you for participating in today’s discussion!
Thierry Musy-Verdel
[email protected]
Stefani Shek
[email protected]
Ida Shum
[email protected]