Manufacturing and Quality Audits Sample Clauses

Manufacturing and Quality Audits. ARIAD shall, and shall cause its Affiliates and Approved Manufacturers to, permit the FDA, the EMEA and other Regulatory Authorities to conduct such inspections of the ARIAD Manufacturing Facilities as the FDA, EMEA or such other Regulatory Authorities may request, and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case related to API and Clinical Product. ARIAD agrees to notify MERCK immediately (and, in any event within [***] ([***]) hours of becoming aware thereof) of any proposed or unannounced quality visit or quality inspections by any Regulatory Authority to an ARIAD Manufacturing Facility (whether owned by ARIAD, an Affiliate or a Approved Manufacturer) and if such inspection is reasonably related to (i) API or Clinical Product or (ii) equipment or systems used in the Manufacture of API or Clinical Product, agrees to keep MERCK fully informed about the results and conclusions of each such regulatory inspection, including actions taken by ARIAD, its Affiliates and Approved Manufacturers to remedy conditions cited in such inspections. If such visit or inspection is directly related to the API or Clinical Product or its Manufacture, ARIAD shall, and shall cause its Affiliates to (and shall use commercially reasonable efforts to cause its Approved Manufacturers to) permit one or more qualified representative(s) of MERCK to be present if requested by MERCK. ARIAD shall promptly, and in no event later than [***] ([***]) business days of receipt thereof, provide MERCK with copies of any written inspection reports issued by such Regulatory Authorities as well as any reports, documents or correspondence with respect to any Regulatory Authority requests or inspections of a ARIAD Manufacturing Facility if such reports, documents or correspondence are directly related to (i) API or Clinical Product or (ii) equipment or systems used in the Manufacture of API or Clinical Product, including, but not limited to, FDA Form 483, Notice of Observation, Establishment Inspection Report, and all correspondence relating thereto; provided that ARIAD may redact any information from such reports, documents or correspondence that is not reasonably related to API or Clinical Product or (ii) equipment or systems used in the Manufacture of API or Clinical Product. ARIAD, its Affiliates or the applicable Approved Manufacturer will be responsible for the development of responses that are required by any Regulatory...
Sample 1
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Manufacturing and Quality Audits. ARIAD shall permit the FDA, and other Regulatory Authorities to conduct inspections of the Manufacturing Facility as the FDA or such other Regulatory Authorities may request, and shall cooperate with such Regulatory Authorities with respect to such inspections and any related matters, in each case related to API. ARIAD agrees to give MEDINOL prior notice (when possible) of any such inspections, and to keep MEDINOL informed about the results and conclusions of each such regulatory inspection, including actions taken by ARIAD to remedy conditions cited in such inspections. ARIAD shall provide MEDINOL with copies of any written inspection reports issued by such Regulatory Authorities and all correspondence between ARIAD and the Regulatory Authorities related thereto, including, but not limited to, FDA Form 483, Notice of Observation, and all correspondence relating thereto, in each case relating to the API or general manufacturing concerns (i.e., Manufacturing Facility compliance or the like). MEDINOL shall have access, to all quality assurance and audits of ARIAD and to the buildings, records and areas of the Manufacturing Facility for the purposes of assessment of regulatory compliance. Additionally, upon notice by MEDINOL, ARIAD shall allow MEDINOL or MEDINOL’s designees, to conduct quality audits of the Manufacturing Facility and quality programs with respect to API no more frequently than once each calendar year; provided, that, MEDINOL may conduct more frequent audits in the event that specific quality issues arise as a result of manufacturing or testing.
Sample 1

Related to Manufacturing and Quality Audits

  • 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.

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • 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.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Program Monitoring and Evaluation The Recipient shall prepare, or cause to be prepared, and furnish to the Association not later than six months after the Closing Date, a report of such scope and in such detail as the Association shall reasonably request, on the execution of the Program, the performance by the Recipient and the Association of their respective obligations under the Legal Agreements and the accomplishment of the purposes of the Financing.”

  • Monitoring and Audit Seller shall provide information on available audit logs and reports relating to cyber and physical and security. Company may audit Seller's records to ensure Seller's compliance with the terms of this Section 1(b)(iii)G (Critical Infrastructure Protection) of this Attachment B (Facility Owned by Seller), provided that Company has provided reasonable notice to Seller and any such records of Seller's will be treated by Company as confidential.

  • Monitoring and Review The Provider agrees to allow access to the Department for purposes of monitoring and review. This access includes but is not limited to client records, fiscal records, staffing records, policy and procedural manuals, facilities, staff, and children in care of the Department. The Department will conduct quality reviews, which may include site-based quality review visits.

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