QA Audit Sample Clauses

QA Audit. During the Term, Lexicon will permit Symphony Icon’s representatives (such representatives to be identified by Symphony Icon in advance and reasonably acceptable to Lexicon and to enter into a confidentiality agreement with Lexicon) to examine and audit, during regular business hours, the work performed by Lexicon hereunder and the Lexicon facilities at which such work is conducted to determine that Lexicon Obligations are being conducted in accordance with the terms of the Agreement, the Development Plan and the Development Budget (“QA Audits”). Symphony Icon shall give Lexicon reasonable advance notice of such QA Audits specifying the scope of the audit. Symphony Icon shall reimburse Lexicon for its time associated with QA Audits; provided, however, that should a particular QA Audit reveal a material deficiency in Lexicon’s quality assurance procedures, then Lexicon will be responsible for all costs of such QA Audit, including Symphony Icon’s reasonable costs associated with such QA Audit, the work to be re-performed and the costs or expenses associated with curing such material deficiencies. Symphony Icon and Lexicon 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. Lexicon shall make commercially reasonable efforts to reconcile all such deficiencies found by Symphony Icon during such QA Audit.
View SourceView Similar (5)
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.
View Source
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. 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
View Source
QA Audit. The Parties will conduct periodic quality assurance auditing in accordance with Section 17 of the Agreement.
View Source
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.
View Source
QA Audit. During the Term, the Company will permit the Symphony Collaboration’s representatives (such representatives (i) to be identified by the Symphony Collaboration 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”). The Symphony Collaboration shall give the Company reasonable advance notice of such QA Audits Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. 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 the Symphony Collaboration’s reasonable costs associated with such QA Audit, the work to be re-performed and the costs or expenses associated with curing such material deficiencies. The Symphony Collaboration 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 the Symphony Collaboration during such QA Audit.
View Source
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.
View Source
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.
View Source

Related to QA Audit

  • SAO AUDIT A. The state auditor may conduct an audit or investigation of any entity receiving funds from the state directly under the Contract or indirectly through a subcontract under the Contract. The acceptance of funds directly under the Contract or indirectly through a subcontract under the Contract acts as acceptance of the authority of the state auditor, under the direction of the legislative audit committee, to conduct an audit or investigation in connection with those funds. Under the direction of the legislative audit committee, an entity that is the subject of an audit or investigation by the state auditor must provide the state auditor with access to any information the state auditor considers relevant to the investigation or audit. B. Grantee shall comply with any rules and procedures of the state auditor in the implementation and enforcement of Section 2262.154 of the Texas Government Code.

  • 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.

  • Inspection & Audit Each party agrees that the relevant books, records (written, electronic, computer related or otherwise), including but not limited to relevant accounting procedures and practices of the party, financial statements and supporting documentation, and documentation related to the work product shall be subject, at any reasonable time, to inspection, examination, review, audit, and copying at any office or location where such records may be found, with or without notice by the State Auditor, Employment Security, the Department of Administration, Budget Division, the Nevada State Attorney General's Office or its Fraud Control Units, the State Legislative Auditor, and with regard to any federal funding, the relevant federal agency, the Comptroller General, the General Accounting Office, the Office of the Inspector General, or any of their authorized representatives.

  • Annual Audits Each fiscal year, the School shall provide for an independent annual financial audit conducted in accordance with Generally Accepted Auditing Standards and Governmental Auditing Standards and performed by a certified public accountant (CPA); provided the Commission may establish an alternative reporting requirement in accordance with State law. The Commission shall provide the guidelines and/or scope of the audit or alternative report and may require minimum CPA qualifications or that the School select from a list of qualified CPAs as provided by the Commission. The School shall provide the completed audit or alternative report to the Commission by November 15 after the conclusion of the fiscal year; provided that the Commission, with reasonable notice to the School, may change the deadline depending on circumstances. The School shall pay for the audit or alternative report if an appropriation is not made by the Legislature for such purpose.

  • Field Audits The Agent has the right at any time and in its discretion to conduct field audits with respect to the Collateral and each Borrower’s Receivables, inventory, business and operations. All field audits shall be at the cost and expense of the Borrowers; it being understood and agreed that, in the absence of an Event of Default, the Borrowers’ maximum liability for field audit costs and expenses shall be limited to the reasonable costs and expenses of only two (2) field audits conducted during any twelve (12) month period (unless the Agent shall conduct a field audit pursuant to Section 1.10 of this Agreement in connection with the joinder of a new “Borrower” hereunder, in which event the Borrowers shall be liable for the costs and expenses of such field audit as well). Any and all field audits conducted following an Event of Default shall be at the Borrowers’ cost and expense, with the foregoing limitation on maximum costs and expense being inapplicable.