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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]