FDA Audit Sample Clauses

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.
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FDA Audit. 14. 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. 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.
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.

Related to FDA Audit

  • Field Audits The Borrower shall permit the Bank to inspect the Inventory, other Tangible Assets and/or other business operations of the Borrower and each Subsidiary, to perform appraisals of the Equipment of the Borrower and each Subsidiary, and to inspect, audit, check and make copies of, and extracts from, the books, records, computer data, computer programs, journals, orders, receipts, correspondence and other data relating to Inventory, Accounts and any other Collateral, the results of which must be satisfactory to the Bank in the Bank’s sole and absolute discretion. All such inspections or audits by the Bank shall be at the Borrower’s sole expense, provided, however, that so long as no Event of Default or Unmatured Event of Default exists, the Borrower shall not be required to reimburse the Bank for inspections or audits more frequently than once each fiscal year.

  • Regulatory Audits BNY Mellon shall, upon reasonable prior notice when possible, make all books and records available to the applicable Voya or Voya Fund regulators and state government representatives or their designees to audit, evaluate and inspect BNY Mellon’s books and records for Voya and such Voya Fund. BNY Mellon agrees to reasonably cooperate with and assist Voya in meeting any regulatory requirements related to audits or inspections imposed upon Voya to the extent that Voya notifies BNY Mellon of such requirements.

  • Post-Closing Audit (a) Promptly following the Closing Date, and in no event later than fifteen (15) days following the Closing Date, and at any time thereafter as ADK may request, Seller shall provide to ADK and its accounting advisors such financial information (the “Financial Information”) related to the business, assets and properties of the Seller purchased by Purchaser pursuant to this Agreement (the “Purchased Business”) as ADK may request in order to enable ADK to determine whether it is or would be required to include separate financial statements of the Purchased Business for any periods prior to Closing in the reports filed by ADK with the SEC under the Securities Exchange Act of 1934, as amended (the “1934 Act”), or in a registration statement filed by ADK with the SEC under the 1933 Act, in accordance with Regulation S X (“Regulation S-X”) promulgated by the SEC (the “Requirement Financial Statements”). Seller will provide to ADK reasonable access to the records of the Seller regarding the Purchased Business, and Seller’s accounting staff and firm(s) will be available to address any questions of ADK and ADK’s accounting advisors pertaining to the Financial Information or the Required Financial Statements.

  • Annual Audit If Subrecipient expends Federal funds in a fiscal year which equal or exceed $750,000 (seven hundred fifty thousand dollars) as specified in OMB Circular A-133-Revised, 2 CFR Part 200.500- Subpart F-Audit Requirements Subrecipient shall cause an audit to be prepared by a Certified Public Accountant (CPA) who is a member in good standing with the American Institute of Certified Public Accountants (AICPA) of the California Society of CPA’s. The audit must be performed annually in accordance with Generally Accepted Auditing Standards (GAAS) authorized by the AICPA and Federal laws and regulations governing the programs in which it participates. Furthermore, County retains the authority to require Subrecipient to submit similarly prepared audit at Subrecipient’s expense even in instances when Subrecipient’s expenditure is less than $750,000. Subrecipient will be required to identify corrective action taken in response to any findings identified by CPA related to their funded activity or program. Subrecipient will ensure an annual financial audit is performed in compliance with the Federal Single Audit Act and will submit two (2) copies of such audit report, including a copy of the management letter, to County within six (6) months of the end of each Contract year in which Subrecipient has received federal funding (i.e., July 1 – June 30). Failure to meet this requirement may result in County denying reimbursement of funds to Subrecipient, as well as future funding qualification. Subrecipients, which are exempt from statutory audit requirements, shall maintain records, which are available for review by County or Federal officials. Subrecipient acknowledges that any and all “Financial Statements” submitted to County pursuant to this County become Public Records and are subject to public inspection pursuant to Sec. 6250 et seq. of the California Government.

  • Independent Audit The Grantee shall submit, in a format specified by the department, the independent financial compliance audit prepared by an independent Certified Public Accountant for the previous fiscal year. The audit shall follow the General Grant Requirements of Sections VIII (F) and (G) and be submitted no later than March 1 of the current fiscal year.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Audit Notwithstanding any other audit requirement, H-GAC reserves the right to conduct or cause to be conducted an independent audit of any transaction under this Agreement, such audit may be performed by the H-GAC local government audit staff, a certified public accountant firm, or other auditors designated by H-GAC and will be conducted in accordance with applicable professional standards and practices. The Contractor understands and agrees that the Contractor shall be liable to the H-GAC for any findings that result in monetary obligations to H-GAC.

  • Field Examination The Administrative Agent or its designee shall have conducted a field examination of the Borrowers’ Accounts, Inventory and related working capital matters and of the Borrowers’ related data processing and other systems, the results of which shall be satisfactory to the Administrative Agent in its sole discretion.

  • Field The term “

  • Independent Auditor The Company’s independent auditor, if any, shall be an independent public accounting firm selected by the Member, which may also be the Member’s independent auditor.

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