Facilities; Audits Clause Samples

Facilities; Audits. (a) SURMODICS shall, at its own cost and expense, ensure that the Facilities are in a qualified and validated state appropriate for inclusion as manufacturing sites for Product as required by the applicable Regulatory Authority at the time the first application for Marketing Authorization is submitted by MERCK. SURMODICS shall (or shall cause its Contract Manufacturers to), at its (or its Contract Manufacturer’s own) cost and expense, maintain the qualification and validation status of the Facilities during the Term. (b) SURMODICS shall Manufacture (or cause to be Manufactured) all Product supplied hereunder at the Facilities. Manufacturing of Product may not be relocated without MERCK’s prior written consent, which consent shall not be unreasonably withheld or delayed. Any such relocation of the Manufacturing of Product shall comply with cGMPs and all applicable laws, regulations and * Portions omitted pursuant to a request for confidential treatment and filed separately with the Securities and Exchange Commission. Regulatory Authority requirements and shall be made in accordance with the Change Control Procedure. (c) SURMODICS shall and shall cause its Contract Manufacturers to permit one or more qualified technical specialists from MERCK, upon at [*] notice and for reasonable duration ([*]) during regular business hours to visit the Facilities, or any other facility which is proposed to be used to Manufacture Product, for purposes of auditing compliance by SURMODICS and its Contract Manufacturers in the Manufacture of Product with applicable laws, regulations and Regulatory Authority requirements, including cGMPs, and with the Quality Agreement; provided, however, that such audits shall be conducted not more than [*] in [*] All information obtained by MERCK in any such inspection or audit, including without limitation the findings and results related thereto, shall be the confidential information of SURMODICS provided, however, that nothing contained herein shall be construed as restricting the right of either party to take action that it deems in good faith to be required by applicable law or regulation. [*] MERCK shall have the right to review all relevant documentation pertinent to such corrective actions implemented by SURMODICS or its Contract Manufacturer.