Common use of Good Laboratory Practices Clause in Contracts

Good Laboratory Practices. The Sponsor acknowledges that University does not comply with and the Project will not be conducted in accordance with the requirements of 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies (the “GLP Regulations”). In any submission by the Sponsor to the U.S. Food and Drug Administration citing the Research, the Sponsor will state that the Research was not intended to be performed in compliance with the GLP Regulations. The Sponsor will indemnify University for all costs and expenses, including attorneys’ fees, incurred in connection with any audit or inspection by the U.S. Food and Drug Administration concerning University’s compliance or noncompliance with the GLP Regulations in the conduct of the research.