Common use of Audits by Regulatory Authorities Clause in Contracts

Audits by Regulatory Authorities. Each Party shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility of the other Party or its Affiliates or subcontractors where Collaboration Activities or other activities with respect to the Product are conducted pursuant to this Agreement by or on behalf of such Party (each, an “Audited Site”). Such Party shall inform the other Party as promptly as practicable and in any event within forty-eight (48) hours of receiving notice of such a Regulatory Authority audit and shall provide reasonable updates to the other Party regarding the audit status. In the event that any Audited Site is found to be non-compliant with one or more of GLP, GCP, GMP, current standards for pharmacovigilance and safety reporting, or requirements related to the protection of human subjects, and such non-compliance relates to or impacts any Collaboration Activities, the audited Party shall submit to the other Party proposed CAPA within forty-five (45)) days after the audited Party, its Affiliate, or its subcontractor receives notification of such non-compliance from the relevant Regulatory Authority. The other Party shall have the right to review and comment on such CAPA, which comments the audited Party shall consider in good faith. The audited Party shall use Commercially Reasonable Efforts to implement such CAPA.

Audits by Regulatory Authorities. Each Party shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility of the other Party or its Affiliates or subcontractors where Collaboration Activities or other activities with respect to the Product are conducted pursuant to this Agreement by or on behalf of such Party (each, an “"Audited Site”"). Such Party shall inform the other Party as promptly as practicable and in any event within forty-eight (48) hours of receiving notice of such a Regulatory Authority audit and shall provide reasonable updates to the other Party regarding the audit status. In the event that any Audited Site is found to be non-compliant with one or more of GLP, GCP, GMP, current standards for pharmacovigilance and safety reporting, or requirements related to the protection of human subjects, and such non-compliance relates to or impacts any Collaboration Activities, the audited Party shall submit to the other Party proposed CAPA within forty-five (45)) days after the audited Party, its Affiliate, or its subcontractor receives notification of such non-compliance from the relevant Regulatory Authority. The other Party shall have the right to review and comment on such CAPA, which comments the audited Party shall consider in good faith. The audited Party shall use Commercially Reasonable Efforts to implement such CAPA.