Quality Assurance Acceptance Clause Samples

Quality Assurance Acceptance. (a) Eurand represents, covenants and warrants to Impax that: (i) all Impax Authorized Generic Product hereunder shall be produced in accordance with cGMP, and Applicable Laws, rules and regulations and that none of the Impax Authorized Generic Product supplied hereunder shall be adulterated or misbranded as defined by Applicable Law; and (ii) all shipments of Impax Authorized Generic Product supplied hereunder shall at the time of delivery, meet the specifications set forth in Anesta’s NDA (including expiration dating). (b) Eurand will use commercially reasonable efforts to maintain throughout the term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Eurand to perform its obligations hereunder in accordance with all Applicable Laws. (c) to Eurand’s knowledge upon due investigation, as of the Effective Date the manufacture or marketing of the Impax Authorized Generic Products in the Territory pursuant to this Agreement does not infringe, misappropriate or otherwise conflict with any intellectual property rights of any Third Party. (d) Eurand shall perform all quality control tests and other inspections required by applicable cGMP standards and Anesta’s NDA and shall furnish to Impax a certificate of analysis together with each lot of Impax Authorized Generic Product shipped to Impax. Eurand will also provide Impax with Material Safety Data Sheets (hereinafter “MSDS”) for the Impax Authorized Generic Products, and updates of same as necessary, but in no event will Eurand provide any specifications and/or quality control standards under the NDA beyond those necessary for Impax to conduct the testing specified in subparagraph 4.3(f). (e) Anesta will promptly notify Impax of any request from the FDA to change Impax Authorized Generic Product specifications or labeling and will notify Impax of any changes in specifications. (f) Impax shall conduct, at its own expense, such tests as it deems necessary to determine the compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a). Impax shall notify Eurand and Anesta within thirty (30) days of its receipt of each shipment of the Impax Authorized Generic Product of any non-compliance of the Impax Authorized Generic Product with the requirements of Section 4.3(a) revealed by such testing, and with respect to any latent defect, within ten (10) days of becoming aware of such defect and provide documents ...
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Quality Assurance Acceptance. 6.1. Shire represents, covenants and warrants to B▇▇▇ that: (a) all AG Product hereunder shall be produced in accordance with cGMP and other Applicable Laws, rules and regulations and that none of the AG Product supplied hereunder shall be adulterated or misbranded as defined by the Act; and (b) all shipments of AG Product supplied hereunder shall meet the specifications and quality control standards set forth in the NDA or otherwise requested by B▇▇▇ and approved by Shire. (c) Shire or a Shire Affiliate will use Commercially Reasonable Efforts to maintain throughout the Term of this Agreement all permits, licenses, registrations and other forms of governmental authorization and approval required in order for Shire to perform its obligations hereunder in accordance with all Applicable Laws. (d) Shire or a Shire Affiliate owns and possesses all right, title and interest in the NDA. (e) Shire has the right to grant all of the rights and licenses granted herein to B▇▇▇ under the Adderall XR Intellectual Property, and it is not under any obligation to any Third Party that conflicts with the terms of this Agreement. 6.2. Shire shall perform all quality control tests and other inspections required by applicable cGMP standards and the NDA and shall furnish to B▇▇▇ a certificate of analysis together with each lot of AG Product shipped to B▇▇▇. Shire will also provide B▇▇▇ with Material Safety Data Sheets as required by Applicable Law for the AG Products, and updates of same as necessary.
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Quality Assurance Acceptance 
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Related to Quality Assurance Acceptance

  • 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.

  • 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.

  • 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 Requirements There are no special Quality Assurance requirements under this Agreement.