Audits/Access. Practitioner shall permit audits and inspection by the United States Department of Health and Human Services, the Comptroller General of the United States, CMS and/or their designees regarding any pertinent contracts, books, documents, papers and records (collectively, "Books and Records") involving or relating to Practitioner's provision of services to Participants. Practitioner shall retain all financial and administrative records relating to the Agreement for the longer of ten (10) years after the termination of this Agreement or the period required by applicable law.
Audits/Access. SERAGEN'S authorized representative(s), after arranging at least five (5) business days in advance with COPHARMA, shall be allowed during regular business hours to examine and inspect that portion of the COPHARMA facilities required for the performance of this Agreement, including periodic inspections relating to the manufacture, testing, handling, storage, packaging and labeling of PRODUCT and to inspect and request copies of all MRR Documentation related to this Agreement, including, but not limited to, the following: Batch records, validation documentation, analytical results on raw materials, components, intermediates and final products, deviation reports, in process testing and PRODUCT reports, trend analysis reports, inspection reports generated by regulatory authorities and responses to reports and inspections by regulatory authorities (both edited to maintain client confidentiality). SERAGEN shall also be allowed to conduct routine annual cGMP audits of COPHARMA facilities. SERAGEN shall send a request to schedule an audit with COPHARMA within sixty (60) days of the proposed audit.
Audits/Access. Before CBSMA begins providing the Technology Services, GTC shall be entitled to a two (2) day audit (the "AUDIT") of the Premises to be used for the provision of the Technology Services. GTC shall provide CBSMA with an agenda for the Audit in advance of the Audit. The Audit shall occur during normal business hours and after reasonable notice to CBSMA. In the event GTC provides CBSMA with any observations noted during the Audit, CBSMA will provide GTC with a written response, including a plan of corrective action to the observations, within fifteen (15) business days of the receipt of the observations by CBSMA. GTC shall have the right to request a reasonable number of subsequent audits ("SUBSEQUENT AUDITS") at times and on terms to be mutually agreed upon, at which GTC shall send no more than two (2) persons in an official auditing capacity, of the Premises used for the provision of the Technology Services. In connection with the Audit or any Subsequent Audit, CBSMA shall permit GTC (and its representatives and consultants) to have access to CBSMA's Premises, equipment, officers and employees and to all technical information and data in CBSMA's possession relating to this Service Agreement or the Technology Services. CBSMA shall not be obligated to provide GTC with access to that portion of its Premises, equipment and information which, at the time of any request for access, is being utilized in the performance of services of a proprietary or confidential nature for CBSMA or for any third party unless such access is required to answer questions from regulatory authorities or other law enforcement agencies, or access is required in regards to the health of a patient receiving Manufactured Product.
Audits/Access. Merrimack shall have the audit and access rights set forth in Section 7 of the Quality Agreement.
Audits/Access. GTC shall be entitled annually and at no cost to GTC as two day audit (the “Audit”) to review LONZA’s manufacturing and quality control procedures and premises solely related to the Services and the GTC Product to ensure LONZA complies with current Good Manufacturing Practice and applicable sections of the BLA and MAA, and the Quality Agreement. The Audit will be requested, with reasonable notice to LONZA and occur at times and on terms to be mutually agreed upon. In connection with the Audit, LONZA shall permit GTC (and its representatives and consultants) to have reasonable access to LONZA’s Premises used for the provision of the Services, equipment, officers and employees and to all reasonable technical information and data in LONZA’s possession relating to this Service Agreement or the Services. LONZA shall not be obligated to provide GTC with access to that portion of its Premises, equipment and information which, at the time of any request for access, is being utilized in the performance of services of a proprietary or confidential nature for LONZA or for any third party unless such access is required to answer questions from regulatory authorities or other law enforcement agencies, or access is required in regards to the health of a patient receiving Manufactured Product. GTC will provide LONZA with an agenda for the audit and will send no more than two persons in an official auditing capacity. In the event that GTC finds any contractual or regulatory deficiencies during such audit it will notify LONZA in writing as to the deficiencies identified and LONZA shall respond in writing within thirty (30) days as to the corrective action plan and schedule to correct the specified deficiencies. The plan and schedule must be mutually acceptable to both parties. GTC shall have the right to request one additional audit per year (i.e. at the request of its marketing partners) at its own cost at a time deemed reasonable by LONZA. In all cases a copy of the audit report will be submitted to LONZA. LONZA shall not be obligated to provide GTC with access to that portion of its premises, equipment and information which, at the time of request for access, is being utilized in the performance of services of a proprietary and confidential nature for LONZA or any third party unless such access is required to answer questions from regulatory authorities or other law enforcement agencies, or in regards to a complaint regarding the health of a patient receiving the GTC Pr...
