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.
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.
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.
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.
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.
QA Audit. The Parties will conduct periodic quality assurance auditing in accordance with Section 17 of the Agreement.
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.
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
