QA Audit Sample Clauses

QA Audit. During the Term, Dynavax will permit Symphony Dynamo’s representatives, such representatives to be identified by Symphony Dynamo in advance and reasonably acceptable to Dynavax, to examine and audit the work performed by Dynavax hereunder and the Dynavax facilities at which such work is conducted to determine that the project assignment is being conducted in accordance with the agreed upon services (“QA Audits”) during regular business hours. Symphony Dynamo shall give Dynavax reasonable advance notice of such QA Audits specifying the scope of the audit. Symphony Dynamo shall reimburse Dynavax for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency in the work performed, then Symphony Dynamo will not be responsible for costs associated with such QA Audit, the work to be re-performed or the costs or expenses associated with curing any material deficiencies. Symphony [ * ] = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Amended and Restated R&D Agreement Dynamo and Dynavax shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such audits including defining material deficiencies to be addressed. Dynavax shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony Dynamo during such QA Audit.
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QA Audit. During the Term, Isis will permit Symphony GenIsis’ representatives, such representatives to be identified by Symphony GenIsis in advance and reasonably acceptable to Isis, to examine and audit the work performed by Isis hereunder and the Isis facilities at which such work is conducted to determine that the project assignment is being conducted in accordance with the agreed upon services (“QA Audits”) during regular business hours. Symphony GenIsis shall give Isis reasonable advance notice of such QA Audits specifying the scope of the audit. Symphony GenIsis shall reimburse Isis for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency, then Symphony GenIsis will not be responsible for costs associated with such QA Audit, the work to be re-performed or the costs or expenses associated with curing any material deficiencies. Symphony GenIsis and Isis shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such audits including defining material deficiencies to be addressed. Isis shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony GenIsis during such QA Audit.
Sample 1
QA Audit. During the term of this Agreement, RRD will permit Eiger Representatives to examine and audit, during regular business hours, the Services conducted by RRD hereunder and the facilities at which such Services are conducted to determine that RRD’s obligations are being conducted in accordance with the terms of this Agreement, the Project Agreement, and the Clinical Development Plan ("QA Audits"). Eiger shall give RRD reasonable advance notice of any such QA Audit specifying the proposed scope of the QA Audit. For QA audits conducted more than [***] per [***] period (other than for cause or follow up audits), Eiger shall reimburse RRD for its time associated in participating in such QA Audit. As used herein, “Eiger Representatives” shall mean representatives identified by Eiger in advance and reasonably acceptable to RRD, each of which shall enter into a confidentiality agreement with RRD (if not already covered by an existing CDA) obligating them to keep confidential any Confidential Information of RRD disclosed in connection with the conduct of any such QA Audit.
Sample 1
QA Audit. During the Term, RRD will permit Dipexium’s representatives (such representatives (i) to be identified by Dipexium in advance and reasonably acceptable to RRD and (ii) to enter into a confidentiality agreement with RRD (if not already covered by an existing CDA)) to examine and audit, during regular business hours, the work performed by RRD hereunder and the facilities at which such work is conducted to determine that RRD’s obligations are being conducted in accordance with the terms of the this Agreement, the Project Agreement, and the Clinical Development Plan (“QA Audits”). Dipexium shall give RRD reasonable advance notice of such QA Audits specifying the scope of the audit.
Sample 1
QA Audit. 12 X. Terms of this Agreement............................................ 12 APPENDIX I: TERMINOLOGY AND DEFINITIONS.................................. 15 APPENDIX II: ABBREVIATIONS............................................... 17 APPENDIX III: CONTACTS................................................... 17 APPENDIX IV: TIMEFRAMES FOR THE EXCHANGE OF SAFETY INFORMATION BETWEEN PARTIES ...................................................... 19 EXHIBIT I.C.: PRODUCT COMPLAINT MANAGEMENT AGREEMENT..................... 21 Note: Certain portions of this document have been marked "[C.I.]" to indicate that confidential treatment has been requested for this confidential information. The confidential portions have been omitted and filed separately with the Securities and Exchange Commission.
Sample 1
QA Audit. During the Term, the Company will permit Holdings’ representatives (such representatives (i) to be identified by Holdings in advance and reasonably acceptable to the Company and (ii) to enter into a confidentiality agreement with the Company) to examine and audit, during regular business hours, the work performed by the Company hereunder and the Company facilities at which such work is conducted to determine that the Company Obligations are being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget (“QA Audits”). Holdings shall give the Company reasonable advance notice of such QA Audits specifying the scope of the audit. If a particular QA Audit reveals a material deficiency in the Company’s quality assurance procedures, then the Company will be responsible for all costs of such QA Audit, including Holdings’ reasonable costs associated with such QA Audit, the work to be re-performed and the costs or expenses associated with curing such material deficiencies. Holdings and the Company shall meet to discuss the results of the QA Audit and, if required, jointly agree upon any actions that will be required as a result of such QA Audit including defining material deficiencies to be addressed. The Company shall make commercially reasonable efforts to reconcile all such deficiencies found by Holdings during such QA Audit.
Sample 1
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QA Audit. The contractor will organise an external audit by a third party. This audit should address the status of the management system for the regulatory functions in the light of ISO 9001:2015. The audit should provide a certification and/or recommendations for further improvement. The contractor will prepare the NRA for the audit, including by supporting an internal audit on-site, before the external audit. Roles of the Contractor and of the End User Within this task, the Contractor shall be responsible for: - reviewing the current NRA management system, identifying possible deviation or gaps with respect to best international practice; - proposing a plan for improving the management system; - preparing, for each individual in situ mission, a detailed agenda with the topics to be covered during the stay of the Contractor´s experts in Ghana and the objectives to achieve, as well as a detailed mission report once the stay is completed; - drafting and revising management system documents identified; - organising an internal audit; - organising an external audit, and - preparing the task report. The End User shall be responsible for: - providing the information relative to the NRA management system, ensuring a fluid exchange of information with the Contractor; - discussing with the Contractor about the priorities to be given to the different procedures; - supporting the in situ missions of the Contractor, ensuring adequate office space and fluent exchange of information during the mission; - reviewing and endorsing the task deliverables prepared by the Contractor, and - participating in the internal and external audit Deliverables • Task report including: o Plan for the drafting/revision of internal regulatory procedures o Internal regulatory documents (new drafts or revised versions) o In situ missions reports o Audit report
Sample 1

Related to QA Audit

  • 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.

  • 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.

  • Records; Audit The Contractor shall maintain during the term of the contract all books of account, reports and records in accordance with generally accepted accounting practices and standards for records directly related to this contract. The Contractor agrees to make available to the City Auditor or the City Auditor’s designee, during normal business hours and in Broward, Miami-Dade or Palm Beach Counties, all books of account, reports, and records relating to this contract. The Contractor shall retain all books of account, reports, and records relating to this contract for the duration of the contract and for three years after the final payment under this Agreement, until all pending audits, investigations or litigation matters relating to the contract are closed, or until expiration of the records retention period prescribed by Florida law or the records retention schedules adopted by the Division of Library and Information Services of the Florida Department of State, whichever is later.

  • 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.

  • 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.

  • 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.

  • 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.

  • Records; Audits Merck will keep, and will cause each of the other Selling Parties, as applicable, to keep, and Moderna will keep, adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable by either Party to the other Party hereunder and ensuring each Party’s compliance hereunder. For the [***] following the end of the Calendar Year to which each will pertain, such books and records of accounting (including those of its Affiliates, as applicable) will be kept at each of their principal place of business. At the request of either Party, the other Party will permit (and procure its Affiliates, to permit) an independent certified public accounting firm of internationally recognized standing selected by the auditing Party and reasonably acceptable to the other Party to have access during normal business hours to such of the records as may be reasonably necessary to verify the accuracy of the payments [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED due hereunder for any Calendar Year ending not more than [***] following the end of any Calendar Year. Such examinations may not be conducted more than once in any Calendar Year or be repeated for any Calendar Year. The accounting firm shall disclose to the auditing Party only whether the reports are correct or incorrect and the amount of any discrepancy. No other Confidential Information shall be provided. If such accounting firm correctly identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within [***] of the date of delivery of such accounting firm’s written report so correctly concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by the auditing Party, provided that if the underpayment or overcharge exceeds [***], the audited Party shall pay the fees. Upon the expiration of [***] following the end of any Calendar Year, absent willful misconduct or fraud by a Party (its Affiliates, as applicable) the calculation of amounts payable with respect to such Calendar Year shall be binding and conclusive upon the Parties, and the Parties shall be released from any liability or accountability with respect to amounts payable for such Calendar Year. The auditing Party shall treat all financial information subject to review under this Section 8.6(c) in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party obligating it to retain all such Confidential Information in confidence pursuant to such confidentiality agreement.

  • Annual Audit Report On or before July 31 of each year, beginning with July 31, 2002, Servicer shall, at its own expense, cause a firm of independent public accountants (who may also render other services to Servicer), which is a member of the American Institute of Certified Public Accountants, to furnish to the Seller and Master Servicer (i) year-end audited (if available) financial statements of the Servicer and (ii) a statement to the effect that such firm has examined certain documents and records for the preceding fiscal year (or during the period from the date of commencement of such Servicer's duties hereunder until the end of such preceding fiscal year in the case of the first such certificate) and that, on the basis of such examination conducted substantially in compliance with the Uniform Single Attestation Program for Mortgage Bankers, such firm is of the opinion that Servicer's overall servicing operations have been conducted in compliance with the Uniform Single Attestation Program for Mortgage Bankers except for such exceptions that, in the opinion of such firm, the Uniform Single Attestation Program for Mortgage Bankers requires it to report, in which case such exceptions shall be set forth in such statement.

  • Periodic Review The General Counsel shall periodically review the Procurement Integrity Procedures with OSC personnel in order to ascertain potential areas of exposure to improper influence and to adopt desirable revisions for more effective avoidance of improper influences.

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