Common use of Audit Findings Clause in Contracts

Audit Findings. 14.2.2.1 At COMPANY’s or AMGEN’s request, an exit meeting shall be held with COMPANY and its representatives and AMGEN and its representatives to discuss audit findings, if any. COMPANY shall provide AMGEN with a copy of the audit report within thirty (30) calendar days upon completion of the audit. For those findings that AMGEN determines in good faith may materially affect AMGEN’s ability to perform the Services, AMGEN shall issue a written response to COMPANY’s report within thirty (30) days of AMGEN’s receipt of such report. AMGEN’s response shall identify the timelines and approach for addressing COMPANY’s findings. 14.3 Regulatory Agency Inspections 14.3.1 COMPANY shall notify AMGEN within twenty-four (24) hours upon notification by any Regulatory Authority of any intended inspection of AMGEN’s facilities or records relating to the manufacturing, testing, and storage of the Product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. 14.3.2 AMGEN will be solely responsible for hosting and managing regulatory inspections at its facilities. 14.3.3 COMPANY will have the right to review and comment on AMGEN’s proposed response to observations raised by the Regulatory Authorities relating to the Product and AMGEN shall consider such comments in good faith. AMGEN shall provide COMPANY with a copy of the final response after submission to any Regulatory Authorities. 14.3.4 AMGEN will inform COMPANY of any critical Regulatory Authority inspection observations not directly relevant to the Product where it can reasonably be assumed the observation impacts upon the Services or Product provided to COMPANY.