Audits of Manufacturing Facilities by Licensee. MTI shall permit the Licensee to perform a standard GMP compliance audit at its manufacturing sites (including any test or storage facilities) relating to Product per year without cause upon reasonable notice during regular business hours. For clarity, MTI shall permit the Licensee to perform GMP compliance audit at the manufacturing site at any time for cause. An audit "for cause" shall mean an audit in response to a regulatory authority audit notice concerning quality system issues or failures.
Appears in 4 contracts
Samples: License and Collaboration Agreement (Menlo Therapeutics, Inc.), License and Collaboration Agreement (Menlo Therapeutics, Inc.), License and Collaboration Agreement (Menlo Therapeutics, Inc.)
