Audits by Regulatory Authorities. Licensee shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Trials or other Development activities or Manufacturing activities are conducted pursuant to this Agreement by Licensee or on its behalf, whether such site or facility is Licensee’s, an Affiliate’s, or a subcontractor’s (each, an “Audited Site”). Licensee shall inform ▇▇▇▇▇▇▇ 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 daily updates 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 Licensed Product, Licensee shall submit to ▇▇▇▇▇▇▇ proposed CAPA within thirty (30) days after Licensee, its Affiliate, or its subcontractor receives notification of such non-compliance from the relevant Regulatory Authority. ▇▇▇▇▇▇▇ shall have the right during the License Term, to review and comment on such CAPA, which comments Licensee shall consider in good faith. Licensee shall use Commercially Reasonable Efforts to implement such CAPA promptly after review and comment by ▇▇▇▇▇▇▇.
Appears in 2 contracts
Sources: License Agreement (Tracon Pharmaceuticals, Inc.), License and Option Agreement (Tracon Pharmaceuticals, Inc.)