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.
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Regulatory and Quality Assurance. (a) Dynavax acknowledges that, except for its or 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 such data as are available to Dynavax which are necessary for Triangle to fulfill all FDA and foreign regulatory reporting requirements in respect of the Finished Drug Substance 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.
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.

  • EMHS Governance, Safety and Quality Requirements 4.1 Participates in the maintenance of a safe work environment.

  • NMHS Governance, Safety and Quality Requirements 3.1 Participates in the maintenance of a safe work environment.

  • 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 10. The Borrower shall make available or cause the State and the DISCOMs to make available necessary budgetary and human resources to fully implement the EMP, the RP and any IPP.

  • Organization, Authority and Qualification of the Company The Company is a corporation duly organized, validly existing and in good standing under the laws of the Cayman Islands and has all necessary corporate power and authority to enter into this Agreement and the Registration Rights 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 which the properties owned or leased by it or the operation of its business makes such licensing or qualification necessary, except to the extent that the failure to be so licensed, qualified or in good standing would not (a) adversely affect the ability of the Company to carry out its obligations under, and to consummate the transactions contemplated by, this Agreement and the Registration Rights Agreement, or (b) otherwise have a Material Adverse Effect. The execution and delivery of this Agreement and the Registration Rights 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 action on the part of the Company and its stockholders. This Agreement has been, and upon its execution the Registration Rights Agreement shall have been, duly executed and delivered by the Company, and (assuming due authorization, execution and delivery by the Purchaser) this Agreement constitutes, and upon its execution the Registration Rights Agreement shall constitute, legal, valid and binding obligations of the Company, enforceable against the Company in accordance with their respective terms.

  • Monitoring and Compliance Every year during the term of this Agreement on the anniversary date of the effective date of the Agreement, the Restaurant shall provide to the United States a narrative report of the actions taken during the reporting period to remove any barriers to access and otherwise enhance accessibility for individuals with disabilities at the Restaurant and any plans for action concerning ADA compliance in the coming year. The report shall include as an exhibit copies of any complaint, whether formal or informal, received during the reporting period alleging that the Restaurant was not being operated in compliance with the ADA or otherwise discriminated against any person on account of disability. The Owner and Operator of the Restaurant shall cooperate in good faith with any and all reasonable requests by the United States for access to the Restaurant and for information and documents concerning the Restaurant's compliance with this Agreement and the ADA. The United States shall have the right to verify compliance with this Agreement and the ADA, both as set forth in this Agreement and through any means available to the general public, including visits to the public areas of the Restaurant and communications with Restaurant staff. The United States shall have the right to inspect the facility at any time, and counsel for the United States need not identify themselves in the course of visits to the public areas.

  • INTERNET PLANNING, ENGINEERING AND OPERATIONS ‌ Job Title: Internet/Web Engineer Job#: 2620 General Characteristics Integrally involved in the development and support of all Internet/Intranet/Extranet sites and supporting systems. Works closely with other IT groups and customers to define the system design and user interface based on customer needs and objectives. Participates in all phases of the development and implementation process, and may act as a project manager on special projects. Ensures the integration of the Web servers and all other supporting systems. Responsible for system tuning, optimization of information/data processing, maintenance and support of the production environment.

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