GMP, Quality Assurance and Other Audits Sample Clauses

GMP, Quality Assurance and Other Audits. Licensee shall have the right to conduct cGMP, quality assurance, and other audits (e.g., Environment, Health & Safety) pursuant to the terms and conditions of the Quality Agreement, but subject to any applicable agreement between Exelixis and a Third Party (such as a contract manufacturing organization) in the event such facility is owned and/or operated by such Third Party.
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GMP, Quality Assurance and Other Audits. During normal business hours and with reasonable advance notice, Purchaser shall have the right to conduct GMP, quality assurance, and other audits of any location relating to the supply of CpG Material hereunder, including at Dynavax’s CMO, as further set forth in the Quality Agreement, and Dynavax shall and shall cause its Affiliates and any such Third Party, including Dynavax’s CMO, to cooperate with Purchaser, its Affiliates, and their representatives in any such audit or inspection as further set forth in the Quality Agreement. Purchaser shall be responsible for the reasonable and documented cost of any audit it conducts, including any reasonable and documented amounts charged by Dynavax’s CMO in connection therewith.
Sample 1
GMP, Quality Assurance and Other Audits. Kissei shall have the right to conduct GMP, quality assurance, and other audits (e.g., Environment, Health & Safety) pursuant to the terms and conditions of the Quality Agreement, but subject to any applicable agreement between Rigel and a Third Party (such as a contract manufacturing organization) in the event such facility is owned and/or operated by such Third Party.
Sample 1

Related to GMP, Quality Assurance and Other Audits

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

  • 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.

  • Audits, Inspections, Visits and Other Duties FIIOC and FSC shall make available during regular business hours all records and other data created and maintained pursuant to this Contract for reasonable audit and inspection by the Trust, any agent or person designated by the Trust, or any regulatory agency having authority over the Trust. Upon reasonable notice by the Trust, FIIOC and FSC shall make available during regular business hours its facilities and premises employed in connection with its performance of this Contract for reasonable visits by the Trust, any agent or person designated by the Trust, or any regulatory agency having authority over the Trust. FSC shall also inform any agent or person designated by the Trust of the existence and results of any audit, inspection or visit by any regulatory agency having authority over the Trust. FSC shall help facilitate periodic reviews by the Fund’s independent auditors (e.g., SOC 1 reports). FSC shall also maintain a continuing awareness of significant emerging regulatory and legislative developments that may affect the Fund and adopt additional procedures for compliance with regulations if necessary. FSC shall consult with independent accountants, legal counsel, officers of the Fund, and the Fund Treasurer’s Office in establishing such policies.

  • 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.

  • Consultant’s Contract Manager and Other Staffing Identified below are the following: (a) the Consultant’s contract manager for this Approved Service Order, and (b) the Consultant(s) and/or employee(s) of the Consultant who will be principally responsible for providing the services and deliverables. If an individual identified below does not have a current Form 700 on file with the City Clerk for a separate agreement with the City, and is required to file a Form 700, the Consultant must comply with the requirements of Subsection 17.2 of the Master Agreement, entitled “Filing Form 700.”

  • Field Examination and Other Fees Subject to any limitations set forth in Section 5.7(c), Borrowers shall pay to Agent, field examination, appraisal, and valuation fees and charges, as and when incurred or chargeable, as follows (i) a fee of $1,000 per day, per examiner, plus out-of-pocket expenses (including travel, meals, and lodging) for each field examination of any Loan Party or its Subsidiaries performed by or on behalf of Agent, and (ii) the fees, charges or expenses paid or incurred by Agent if it elects to employ the services of one or more third Persons to appraise the Collateral, or any portion thereof.

  • VERIFICATION OF LICENSES, CREDENTIALS AND OTHER DOCUMENTS CONTRACTOR shall submit to LEA a staff list, and copies of all current licenses, credentials, certifications, permits and/or other documents which entitle the holder to provide special education and/or related services by individuals employed, contracted, and/or otherwise hired or sub-contracted by CONTRACTOR. CONTRACTOR shall ensure that all licenses, credentials, permits or other documents are on file at the office of the County Superintendent of Schools. CONTRACTOR shall provide the LEA with the verified dates of fingerprint clearance, Department of Justice clearance and Tuberculosis Test clearance for all employees, approved subcontractors and/or volunteers prior to such individuals starting to work with any student. CONTRACTOR shall monitor the status of licenses, credentials, certifications, permits and/or other documents for all individuals employed, contracted, and/or otherwise hired by CONTRACTOR. CONTRACTOR shall notify LEA and CDE in writing within forty-five (45) days when personnel changes occur which may affect the provision of special education and/or related services to LEA students. CONTRACTOR shall notify LEA within forty-five (45) days if any such licenses, certifications or waivers are expired, suspended, revoked, rescinded, challenged pursuant to an administrative or legal complaint or lawsuit, or otherwise nullified during the effective period of this Master Contract. The LEA shall not be obligated to pay for any services provided by a person whose such licenses, certifications or waivers are expired, suspended, revoked, rescinded, or otherwise nullified during the period which such person is providing services under this Master Contract. Failure to notify the LEA and CDE of any changes in credentialing/licensed staff may result in suspension or revocation of CDE certification and/or suspension or termination of this Master Contract by the LEA.

  • 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 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.

  • Project Monitoring Reporting and Evaluation The Recipient shall furnish to the Association each Project Report not later than forty-five (45) days after the end of each calendar semester, covering the calendar semester.

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