Common use of Facility Audits Clause in Contracts

Facility Audits. 2.1. GenMark or a third party designated by GenMark shall have the right to inspect/audit LBS’s facilities and the facilities located the Manufacturing Location and all documents and records relating to the Products, e.g., the design, manufacturing, quality control, testing, storage, packaging, and handling of the Products. LBS shall cooperate (and cause the cooperation) with any such inspection/audit, and comply (and cause the compliance) with any reasonable requests made by GenMark in relation to such inspection/audit. During an audit, LBS shall make a qualified member of staff available to Genmark or third party designated by Genmark. Any such inspection/audit shall be made by GenMark at (subject to Section [1.20]) GenMark’s expense during LBS’s business hours applicable to the facility at issue and with reasonable advance notice. All information gathered and data reviewed during any such audit shall be Confidential Information according to the provisions of Section 20 of this Agreement. If a third party conducts an inspection under this Section, LBS may require, and GenMark will procure, that the third party enter into a reasonable confidentiality agreement on terms no less than those set out in Section 20 of this Agreement. 2.2. Where such inspection/audit detects any manufacturing quality control issue which has an adverse impact on the quality of the Products or their compliance with Specifications, Product safety, efficacy, stability, or performance, such issue must be cured without delay by LBS at LBS’s expense (including reimbursement to GenMark for the full inspection/audit cost). LBS shall promptly provide GenMark with proposed corrective and preventive actions and with time-lines for implementation. LBS will provide GenMark with reasonable opportunities to be involved in and to provide input with respect to each corrective and preventive action. 2.3. LBS must permit and cooperate with any inspection/audit by any Governmental Authorities, and comply with any requests made by the Governmental Authorities. LBS will notify GenMark immediately of any such inspection/audit. Where it is relating to Genmark product, LBS shall promptly provide GenMark with copies of any inspection reports it receives from any Governmental Authority or notice of any claim or action from any Governmental Authority relating to non-compliance with any applicable laws, rules, or regulations. Except to the extent as may be required by law, LBS shall not communicate directly with any governmental agency regarding the Product except through or with the explicit review and approval of GenMark 2.4. LBS will notify GenMark within one (1) day of any citations or other communications from Governmental Authorities that may affect the manufacturing of the Products or services provided to GenMark. LBS will provide GenMark with copies of any such citations or other communications from Governmental Authorities upon receipt.