Common use of Facility Audits Clause in Contracts

Facility Audits. Subject to ▇▇▇▇▇▇▇’▇ safety procedures, access control SOPs, and confidentiality limitations, Brammer will permit Customer’s representatives, not more frequently than [**], during the term of this Agreement at mutually agreed upon times to audit the Facility as more specifically set forth in the Quality Agreement, provided, however, that Customer may conduct any additional for-cause audits at mutually agreed upon times with reasonable advance notification to Brammer. Customer will give Brammer reasonable advanced notice of any proposed routine audit but no fewer than [**] prior notice for a for-cause audit, and identify the individuals who will be in attendance; provided that a general quality audit will require a minimum of [**] prior notice. All routine audits will be during ▇▇▇▇▇▇▇’▇ normal business hours on weekdays and conducted in a manner that does not unreasonably interfere with ▇▇▇▇▇▇▇’▇ Services and does not otherwise unreasonably interfere with normal business activities. Brammer will [**] make its Facilities and all relevant records available for inspection by representatives of Regulatory Authorities in compliance with Applicable Laws, [**] All information, records, or business information concerning Brammer that is disclosed or made available by Brammer to Customer employees and representatives, and representatives of Regulatory Authorities, or otherwise obtained by such employees and representatives, in connection with any audit will be deemed to be Confidential Information of Brammer. [**]

Facility Audits. Subject to ▇▇▇▇▇▇▇’▇ safety procedures, access control SOPs, and confidentiality limitations, Brammer will permit Customer’s representatives, not more frequently than once per [**]] period, during the term Term of this Agreement at mutually agreed upon times to audit the Facility as more specifically set forth in the Quality Agreement, provided, however, that Customer may conduct any additional for-cause audits at mutually agreed upon times with reasonable advance notification or audits relating to Brammeran urgent Product safety issue. Customer will give Brammer (a) reasonable advanced notice of any proposed routine for-cause audit or an audit relating to an urgent Product safety issue (as determined in Customer’s reasonable discretion) but no fewer than [**] and (b) at least [**] prior notice for a for-cause of any general quality audit, and . Any such audit notice shall identify the individuals who will be in attendance; provided that a general quality audit will require a minimum of [**] prior notice. All routine audits will be during ▇▇▇▇▇▇▇’▇ normal business hours on weekdays and conducted in a manner that does not unreasonably interfere with ▇▇▇▇▇▇▇’▇ Services Manufacturing and development activities and does not otherwise unreasonably interfere with normal business activities. Brammer will will, [**] make its Facilities and all relevant records available for inspection by representatives of Regulatory Authorities in compliance with Applicable Laws, and [**] ]. All information, records, or business information concerning Brammer that is disclosed or made available by Brammer to Customer Customer’s employees and representatives, and representatives of Regulatory Authorities, or otherwise obtained by such employees and representatives, in connection with any audit and which does not constitute Customer Confidential Information will be deemed to be Confidential Information of Brammer. To the extent any audit by Regulatory Authorities of the Facility is necessary to obtain Regulatory Approval of the Product (and does not relate to any other products Brammer manufactures or supplies to any other Person), [**].

Facility Audits. Subject to ▇▇▇▇▇▇▇’▇ safety procedures, access control SOPs, and confidentiality limitations, Brammer will permit Customer’s up to [**] Customer representatives, not more frequently than [**]] period, during the term Term of this Agreement at mutually agreed upon times to audit the Facility for up to [**], as more specifically set forth in the Quality Agreement, provided, however, that Customer may conduct any additional for-cause audits at mutually agreed upon times with reasonable advance notification to Brammer. Customer will give Brammer reasonable advanced notice of any proposed routine audit but no fewer than [**] prior notice for a for-cause audit, and identify the individuals who will be in attendance; provided that a general quality audit will require a minimum of [**] prior notice. All routine audits will be during ▇▇▇▇▇▇▇’▇ normal business hours on weekdays and conducted in a manner that does not unreasonably interfere with ▇▇▇▇▇▇▇’▇ Services manufacturing and development activities and does not otherwise unreasonably interfere with normal business activities. Brammer will [**] make its Facilities and all relevant records available for inspection by representatives of Regulatory Authorities in compliance with Applicable Laws, [**] All information, records, or business information concerning Brammer that is disclosed or made available by Brammer to Customer Customer’s employees and representatives, and representatives of Regulatory Authorities, or otherwise obtained by such employees and representatives, in connection with any audit and does not constitute Customer Confidential Information will be deemed to be Confidential Information of Brammer. [**].