Common use of Facility Audits Clause in Contracts

Facility Audits. Client shall have the right, acting reasonably and at its expense, upon not less than ten (10) business days advance written notice and during regular business hours, [*****], except for Cause, during the Term hereof, to inspect and audit the Facility to assure compliance with the Agreed Standards and other prevailing quality system requirements. Client shall have the right to conduct a “for Cause” audit during normal working hours with 24 hr advance notice. Such audit shall be limited to those portions of or areas within the Facility that are involved in the production of Biologic including, but not limited to, manufacturing suites and other related areas supporting production of Biologic (e.g., warehouse, water systems, storage, buffer and media prep), and shall be conducted in a manner so as to minimize disruption of business operations. Client shall have the right to appoint an appropriately qualified Third Party selected by Client and reasonably acceptable to CMO to conduct the audit. As a condition to allowing such Third Party contractor to conduct such audit, CMO and/or its Affiliate may require such Third Party to execute a non-disclosure agreement with CMO. CMO and/or its Affiliates reserve the right, at their sole discretion, to deny Client or its Third Party contractor access to documentation that constitutes or contains CMO Technology or other proprietary or Confidential Information of CMO and/or its Affiliates or any of their respective customers; provided, however, that to the extent access to any portion of such documentation is reasonably necessary for the conduct of the audit, CMO and/or its Affiliate shall permit Client or its Third Party contractor to inspect such portion of such documentation at the Facility but Client and its Third Party contractor shall not have the right to remove, copy or make detailed notes of such documentation; and provided, further, that in no event shall CMO and/or its Affiliates be obligated to provide Client or its Third Party contractor with access to any documentation (or portion thereof) to the extent that providing such access would constitute a breach or violation of CMO’s and/or its Affiliates’ obligations to any Third Party. All information disclosed to or otherwise observed by Client or its Third Party contractor during any such audit shall be deemed Confidential Information of CMO and/or its Affiliates, respectively. Client or its Third Party contractor shall at all times while present at the Facility comply with all applicable health, safety, environmental and security laws and, to the extent provided to such representatives, applicable CMO (and/or Affiliate) policies and procedures.

Facility Audits. Client The JDC shall have propose and submit to the rightJSC for approval a schedule for periodic audit and inspection of the facilities of any Third Party contract manufacturer on at least an annual basis subject to the terms of any applicable existing contract with a Third Party contract manufacturer. Pursuant to the schedule approved by the JSC, acting reasonably and at its expenseor upon request of the JDC, upon the Lead Manufacturing Party shall conduct an inspection or audit of the facilities of such Third Party contract manufacturers. The Lead Manufacturing Party shall provide not less than ten (10) business days advance written [ * ] notice to the other Party of any planned inspection and during regular business hourssuch other Party shall be permitted to participate in any audit, [*****]provided that, except for Causeif the consent of the Third [ * ] = Certain confidential information contained in this document, during the Term hereofmarked by brackets, to inspect has been omitted and audit the Facility to assure compliance filed separately with the Agreed Standards Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Party contract manufacturer is required under the applicable contract to allow such other prevailing quality system requirementsParty to participate in such audit, the Lead Manufacturing Party shall use Diligent Efforts to obtain such consent. Client shall have Any inspection or audit requested by the right JDC (other than pursuant to conduct a “for Cause” audit during normal working hours with 24 hr advance notice. Such audit the schedule approved by the JSC) shall be limited to those portions of or areas within the Facility that are involved in the production of Biologic including, but not limited to, manufacturing suites and other related areas supporting production of Biologic (e.g., warehouse, water systems, storage, buffer and media prep)conducted no more frequently than [ * ] at a given facility, and shall be conducted in a manner so occur as to minimize disruption promptly as possible following written notice by the JDC of business operations. Client shall have the right to appoint an appropriately qualified Third Party selected by Client and reasonably acceptable to CMO to conduct the audit. As a condition to allowing its desire for such Third Party contractor to conduct such inspection or audit, CMO and/or its Affiliate may require such Third Party to execute a non-disclosure agreement with CMO. CMO and/or its Affiliates reserve the right, at their sole discretion, to deny Client or its Third Party contractor access to documentation that constitutes or contains CMO Technology or other proprietary or Confidential Information of CMO and/or its Affiliates or any of their respective customers; provided, however, that to the extent access to any portion of such documentation is reasonably necessary for the conduct of the audit, CMO and/or its Affiliate shall permit Client or its Third Party contractor to inspect such portion of such documentation at the Facility but Client and its Third Party contractor shall not have the right to remove, copy or make detailed notes of such documentation; and provided, further, that in no event shall CMO and/or its Affiliates be obligated to provide Client or its Third Party contractor with access to any documentation such inspection commence later than [ * ] thereafter (or portion thereof) to the extent that providing such access would constitute a breach or violation of CMO’s and/or its Affiliates’ obligations to any Third Party. All information disclosed to or otherwise observed by Client or its Third Party contractor during any unless such audit is triggered by a material safety or GMP non-conformance issue, in which case the audit may be conducted as frequently as necessary and the maximum notice period shall be deemed Confidential Information of CMO and/or its Affiliates, respectively[ * ] if permitted under the applicable contract). Client Costs associated with auditing shall be Development Costs or its Third Party contractor shall at all times while present at the Facility comply with all applicable health, safety, environmental and security laws and, to the extent provided to such representatives, applicable CMO (and/or Affiliate) policies and proceduresCommercialization Costs as applicable.