Common use of cGMP Compliance and QA Audits Clause in Contracts

cGMP Compliance and QA Audits. Upon written request to Eagle by MDCO and subject to the consent of Eagle, not to be unreasonably withheld, delayed or conditioned, MDCO may accompany Eagle to a Third Party Manufacturer’s Manufacturing facilities during normal business hours to discuss any issues regarding Manufacturing and management personnel, and to review and inspect (i) the Manufacturing and storage facilities, (ii) the quality control procedures, and/or (iii) any records and reports pertinent to the Manufacture, disposition or transport of Product as may be necessary to evidence the Third Party Manufacturer’s compliance with all applicable Regulatory Approvals for the Manufacture of Product supplied to MDCO hereunder, including compliance with cGMP. MDCO may make such visits with Eagle to the Third Party Manufacturer’s Manufacturing facilities once per calendar year unless MDCO identifies, during any such visit or as a result of any Form 483 received by such Third Party Manufacturer, any defects or deficiencies provided in any of the foregoing clauses (i), (ii) or (iii) above, in which case MDCO may make as many subsequent visits to such facilities as are reasonably required to determine whether such defects or deficiencies have been cured. In addition to the foregoing, the Quality Agreement shall include a provision providing MDCO with the right, during normal business hours, to conduct annual supply oversight and compliance audits of all Eagle facilities and records used in or related to the supply of Product to MDCO hereunder.