Regulatory and Quality Assurance Sample Clauses

Regulatory and Quality Assurance. (a) Dynavax acknowledges that, except for any of its subcontractor's DMF's, Triangle shall be solely responsible for (i) filing all regulatory documents with the FDA and foreign regulatory agencies in connection with the Development Program and Registration of all Licensed Products and (ii) quality assurance oversight in respect of the Licensed Products. Dynavax will reasonably assist Triangle by providing with such data as area available to Dynavax which are necessary for Triangle to fulfill all FDA and foreign regulatory reporting requirements in respect of the Licensed Products supplied hereunder. Dynavax will use its best efforts to cause any subcontractor which it uses in connection with the manufacture of the Licensed Products to fully disclose all data relating to such subcontractor's manufacturing activities to Triangle. (b) Dynavax shall use its best efforts to cause any subcontractors it uses in connection with the supply and manufacture of the Licensed Products to enter into such contractual arrangements with Triangle as are reasonably necessary to comply with applicable FDA laws and regulations, relating to the manufacturing, control, testing and release of the Licensed Products, including the draft guidance entitled "Cooperative, Manufacturing Arrangements for Licensed Products".
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Regulatory and Quality Assurance 

Related to Regulatory and Quality Assurance

  • SMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Participates in an annual performance development review. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with Government, WA Health, South Metropolitan Health Service and Departmental / Program specific policies and procedures. 4.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment. 4.2 Actively participates in the Peak Performance program. 4.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 4.4 Completes mandatory training (including safety and quality training) as relevant to role. 4.5 Performs duties in accordance with the EMHS Vision and Values, WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act and Government, WA Health, EMHS and Departmental / Program specific policies and procedures.

  • NMHS Governance, Safety and Quality Requirements 2.1 Participates in the maintenance of a safe work environment. 2.2 Participates in an annual performance development review. 2.3 Supports the delivery of safe patient care and the consumers’ experience including participation in continuous quality improvement activities in accordance with the requirements of the National Safety and Quality Health Service Standards and other recognised health standards. 2.4 Completes mandatory training (including safety and quality training) as relevant to role. 2.5 Performs duties in accordance with Government, WA Health, North Metropolitan Health Service and Departmental / Program specific policies and procedures. 2.6 Abides by the WA Health Code of Conduct, Occupational Safety and Health legislation, the Disability Services Act and the Equal Opportunity Act.

  • COUNTY’S QUALITY ASSURANCE PLAN The County or its agent will evaluate the Contractor’s performance under this Contract on not less than an annual basis. Such evaluation will include assessing the Contractor’s compliance with all Contract terms and conditions and performance standards. Contractor deficiencies which the County determines are severe or continuing and that may place performance of the Contract in jeopardy if not corrected will be reported to the Board of Supervisors. The report will include improvement/corrective action measures taken by the County and the Contractor. If improvement does not occur consistent with the corrective action measures, the County may terminate this Contract or impose other penalties as specified in this Contract.

  • Quality Assurance/Quality Control Contractor shall establish and maintain a quality assurance/quality control program which shall include procedures for continuous control of all construction and comprehensive inspection and testing of all items of Work, including any Work performed by Subcontractors, so as to ensure complete conformance to the Contract with respect to materials, workmanship, construction, finish, functional performance, and identification. The program established by Contractor shall comply with any quality assurance/quality control requirements incorporated in the Contract.

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

  • Human and Financial Resources to Implement Safeguards Requirements The Borrower shall make available necessary budgetary and human resources to fully implement the EMP and the RP.

  • Organization, Authority and Qualification of the Company (a) The Company is a corporation duly organized and validly existing, and, if it had filed audited financial statements for 2004, 2005 and 2006, it would be in good standing under the Laws of the jurisdiction of its incorporation and has all necessary power and authority to enter into this Agreement and the Stockholder Agreement, to carry out its obligations hereunder and thereunder and to consummate the transactions contemplated hereby and thereby. The Company is duly licensed or qualified to do business and is in good standing in each jurisdiction in which the properties owned or leased by it or the operation of its business makes such licensing or qualification necessary, except jurisdictions in which the failure to be licensed or qualified would not, individually or in the aggregate, have a material adverse effect on the Company and the Subsidiaries taken as a whole. The execution and delivery of this Agreement and the Stockholder Agreement by the Company, the performance by the Company of its obligations hereunder and thereunder and the consummation by the Company of the transactions contemplated hereby and thereby have been duly authorized by all requisite corporate action on the part of the Company. This Agreement has been, and upon its execution and delivery at the Closing, the Stockholder Agreement will have been, duly executed and delivered by the Company, and (assuming due authorization, execution and delivery by the Investor) this Agreement constitutes, and upon its execution the Stockholder Agreement will constitute, legal, valid and binding obligations of the Company, enforceable against the Company in accordance with their respective terms, subject to the effect of any applicable bankruptcy, insolvency (including all Laws relating to fraudulent transfers), reorganization, moratorium or similar Laws affecting creditors’ rights generally and subject to the effect of general principles of equity (regardless of whether considered in a proceeding at law or in equity) or any applicable conservatorship or receivership provisions of the FDIA (“FDIA Limitations”). (b) The Company has not taken any action that in any material respect conflicts with, constitutes a default under or results in a violation of any provision of its Articles of Incorporation or Bylaws (or similar organizational documents). True and complete copies of the Articles of Incorporation and Bylaws of the Company, each as in effect on the date hereof, have been delivered by the Company to the Investor.

  • Quality Assurance Program An employee shall be entitled to leave of absence without loss of earnings from her or his regularly scheduled working hours for the purpose of writing examinations required by the College of Nurses of Ontario arising out of the Quality Assurance Program.

  • Organization, Authority and Qualification (a) Parent is a corporation duly incorporated, validly existing and in good standing under the Laws of the State of Delaware and has all necessary corporate power and authority to (i) own, operate or lease the properties, rights and assets owned, operated or leased by it that are related to the Business (including the Purchased Assets or the Interests, as applicable) and to carry on the Business as it has been and is currently conducted, (ii) enter into, execute and deliver this Agreement and the Ancillary Agreements to which it is or will be a party, (iii) carry out its obligations hereunder and thereunder and (iv) consummate the transactions contemplated hereby and thereby. Parent is duly authorized, licensed or qualified to do business and is in good standing (or its local equivalent) under the Laws in each jurisdiction in which the properties, rights or assets owned or leased by it or the operation of the Business by it makes such authorization, licensing or qualification necessary, except to the extent that the failure to be so licensed, qualified or in good standing has not had and would not have a Seller Material Adverse Effect. Assuming the accuracy of Buyer’s representation in Section 4.10, the execution and delivery by Parent of this Agreement and the Ancillary Agreements to which it is or will be a party, the performance by Parent of its obligations hereunder and thereunder and the consummation by Parent of the transactions contemplated hereby and thereby have been duly authorized by all requisite corporate action on the part of Parent. This Agreement has been, and upon their execution each of the Ancillary Agreements to which Parent is a party will be, (i) duly and validly executed and delivered by Parent, and, (ii) assuming due authorization, execution and delivery by each of the other parties hereto and thereto (other than Affiliates of Parent), a legal, valid and binding obligation of Parent, enforceable against it in accordance with its terms, except as such enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar Laws affecting enforcement of creditors’ rights generally and by general principles of equity (whether applied in a proceeding at law or in equity) (the “Enforceability Exceptions”). (b) Each Seller has been duly incorporated or formed, is a validly existing legal entity and, where applicable, is in good standing (or its local equivalent) under the Laws of the jurisdiction of its incorporation or formation, and has all necessary corporate (or other) power and authority to (i) own, operate or lease the properties, rights and assets now owned, operated or leased by it that are related to the Business (including the Purchased Assets or the Interests, as applicable) and to carry on the Business as it has been and is currently conducted, (ii) enter into, execute and deliver this Agreement and the Ancillary Agreements to which it is or will be a party, (iii) carry out its obligations hereunder and thereunder and (iv) consummate the transactions contemplated hereby and thereby. Each Seller is duly authorized, licensed or qualified to do business and is in good standing (or its local equivalent) under the Laws in each jurisdiction in which the properties, rights or assets owned or leased by it or the operation of the Business by it makes such authorization, licensing or qualification necessary, except to the extent that the failure to be so licensed, qualified or in good standing has not had and would not have a Seller Material Adverse Effect. Each Seller is a wholly owned, direct or indirect, Subsidiary of Parent. The execution and delivery by each Seller of this Agreement and the Ancillary Agreements to which it is or will be a party, the performance by such Seller of its obligations hereunder and thereunder and the consummation by such Seller of the transactions contemplated hereby and thereby will be, when executed as provided in this Agreement, duly authorized by all requisite corporate (or other) action on the part of such Seller. This Agreement and each Ancillary Agreement to which a Seller is a party will be, when executed as provided in this Agreement, (i) duly and validly executed and delivered by such Seller and, (ii) assuming due authorization, execution and delivery by each of the other parties hereto and thereto (other than Parent or any Affiliates of Parent), a legal, valid and binding obligation of such Seller enforceable against it in accordance with its terms, except as such enforcement may be limited by the Enforceability Exceptions.

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