FDA Audit. Upon the request of the FDA or any other Governmental Authority, such agency shall be granted access to observe and inspect each Party’s facilities and/or the procedures used in the manufacturing or warehousing of Product and to audit such facilities and such procedures for compliance with current good manufacturing practices and/or other Applicable Laws. The Party being audited shall provide notice to the other Party. The audited Party shall provide a reasonable written description of any such governmental inquiries, notifications or inspections within two (2) days after such visit or inquiry; provided, that the audited Party shall also furnish to the other Party (a) any report or correspondence issued by the FDA or other Governmental Authority in connection with such visit or inquiry, including any FDA Form 483 (List of Inspectional Observations) or applicable portions of any FDA Warning Letters which pertain to Product in the Territory and (b) in accordance with above, copies of proposed responses or explanations relating to items set forth above, in each case redacted of trade secrets or other Confidential Information of such Party or its Affiliates that are unrelated to its obligations under this Agreement or are unrelated to Product. After the filing of a response with the FDA or other Governmental Authority, the filing Party will promptly notify the other Party of any further contacts with such agency relating to the subject matter of the response.
FDA Audit. In the event that BROOKWOOOD receives a Notice of Inspection (a “Notice”) from the FDA which relates to this Agreement, BROOKWOOOD shall: (a) notify CLIENT promptly of such Notice; (b) keep CLIENT informed of the progress of the inspection; and (c) provide to CLIENT a copy of any documents produced to the FDA pursuant to such Notice. CLIENT acknowledges that it is BROOKWOOOD’s obligation to respond to a Notice directed to BROOKWOOOD and BROOKWOOOD must respond to the Notice without advice from, or consultation with CLIENT concerning the contents thereof.
FDA Audit. PHMD has represented to the U.S. Food and Drug Administration (the “FDA”) that the observations contained in the Form 483 report dated June 16, 2015 will be remediated and finalized within the timeframes proposed by PHMD to the FDA. To the extent that such remediation actions are under the control of PHMD, PHMD shall be responsible for taking such remediation actions. To the extent that such remediation actions are under the control of Purchaser, Purchaser will use commercially reasonable efforts to take such actions; provided, that in no event shall Purchaser incur any out-of-pocket costs and expenses as a result thereof unless they are reimbursed by PHMD. If (a) such observations are not remediated within such timeframes to the satisfaction of the FDA, (b) the remediation of such observations is otherwise unsatisfactory to the FDA (in either (a) or (b), other than as a result of Purchaser failing to use commercially reasonable efforts to take such remediation actions that are under its control but subject to the limit on out-of-pocket costs and expenses stated above) or (c) the steps necessary to remediate are other than as represented by PHMD to Purchaser, PHMD shall be responsible for any and all out-of-pocket costs and expenses resulting from such failure and/or unanticipated circumstances.
FDA Audit. Subsequent to the Closing, Purchaser shall inform Sellers of any and all contacts and communications from the FDA related to the FDA Audit described in Section 5.10 herein, in sufficient time for Sellers to participate in person in any inspections, investigations or meetings by or with the FDA related to the FDA Audit. To the extent it may do so, Purchaser will not schedule any audits, inspections, investigations or meetings with the FDA relating to the FDA Audit without ensuring that a representative of Sellers can participate in person, if they so choose. Purchaser agrees that Sellers shall, at their discretion, have the right to fully participate in any such audits, inspections, investigations and meetings with the FDA and Purchaser which may obligate Sellers pursuant to Section 5.10. Purchaser agrees that Sellers shall have the right, at Sellers' discretion, to discuss the terms and conditions of such obligations with the FDA (and Purchaser shall have the right to take part in such discussions) and Purchaser shall cooperate in all respects with Sellers regarding the conduct, results and responses to such audits or inspections and all such negotiations. Purchaser shall provide Sellers with a copy of any FDA comments or observations relating to the FDA Audit and shall provide Sellers with a copy of any draft response to the FDA at least three days prior to submission. Purchaser agrees to accept and incorporate all reasonable comments of Sellers thereto.
FDA Audit. Upon request, Medidata shall make available to the U.S. Food and Drug Administration (“FDA”) all records lawfully required by governmental regulations relating to the Hosting Services. If the FDA performs an audit, Customer shall reimburse Medidata and its subcontractors for time expended and expenses incurred in conjunction with any such audit, except to the extent that any such audit findings require remedial actions directly and solely attributable to the Hosting Services and/or Medidata Applications. If any governmental/regulatory authority gives notice of its intention to conduct an audit or take any other regulatory action with respect to the Hosting Services and/or Medidata Applications, Medidata will promptly give Customer notice thereof, and Customer shall have the right to be present at any such audit or regulatory action.
