Audits, Monitoring and Regulatory Inspections Sample Clauses

Audits, Monitoring and Regulatory Inspections. (a) Dendreon shall have the right to audit Collection Center’s Sites, systems and documents (including all related Procedures) on an annual basis, or as may otherwise be warranted to comply with law or regulation or address patient care issues. Such audits will be limited in scope to those items directly related to Collection Center’s performance of the Services. Dendreon will provide Collection Center with reasonable advance notice for scheduling an audit. In addition, Dendreon and Collection Center agree to work together to provide ongoing monitoring of Collection Center’s operations and processes and regular site visits by Dendreon for monitoring purposes, each as related to the Services. Upon qualification of a site to provide Services, Collection Center and Dendreon shall coordinate such that Dendreon personnel may initially be present at the initiation of Services at any individual site. (b) Dendreon may audit Collection Center on a “for cause” basis. Collection Center shall schedule and host “for cause” audits prompted by concerns for patient safety within forty-eight (48) hours of Dendreon’s request. (c) Dendreon shall promptly notify Collection Center with a report of any deficiencies identified in such audit or inspection. Collection Center shall have thirty (30) days, unless otherwise agreed to in writing, after such deficiencies are identified to provide Dendreon with a written report outlining a corrective action plan and to bring any such deficiency into full compliance within the period agreed upon by both parties. If such deficiency is not corrected within the period of time agreed upon, Dendreon shall have the right to revoke the corresponding Site’s approval status to perform collections for Dendreon. (d) Collection Center will notify Dendreon of any inspections or actions by a regulatory agency or other enforcement body that will impact a Site’s availability to perform the Services within twenty-four (24) hours of receiving notification from a regulatory agency or enforcement body. (As a registered tissue establishment, each Site is subject to routine inspection from FDA.) Collection Center must notify Dendreon of the findings of all inspections which are disclosed or discovered during the inspection wrap-up conference within 24 hours of the close of such inspection or action. If Collection Center is inspected for services other than those Services provided under this Agreement, Collection Center must notify Dendreon in writing of findin...
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Related to Audits, Monitoring and Regulatory Inspections

  • Regulatory Inspections Manufacturer will permit Rhythm or its agents to be present and participate in any visit or inspection by any Authority of the Facility (to the extent it relates in any way to any Product) or the Manufacturing Process. Manufacturer will give as much advance notice as reasonably possible to Rhythm of any such visit or inspection. Manufacturer will provide Rhythm with a copy of any report or other written communication * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Development and/or Manufacture of Product) or the Manufacturing Process, within two (2) business days after receipt, and will consult with, and require approval from, Rhythm before responding to each such communication. Manufacturer will provide Rhythm with a copy of its final responses within five (5) business days after submission.

  • 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.

  • OIG INSPECTION, AUDIT, AND REVIEW RIGHTS ‌ In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine or request copies of Xxxxxx’x books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Xxxxxx’x locations for the purpose of verifying and evaluating: (a) Xxxxxx’x compliance with the terms of this IA and (b) Xxxxxx’x compliance with the requirements of the Federal health care programs. The documentation described above shall be made available by Xxxxxx to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview Xxxxxx and any of Xxxxxx’x employees or contractors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Xxxxxx shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Xxxxxx’x employees and contractors may elect to be interviewed with or without a representative of Xxxxxx present.

  • 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 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.

  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

  • Audits/Inspections Contractor agrees to permit the County’s Auditor-Controller or the Auditor- Controller’s authorized representative (including auditors from a private auditing firm hired by the County) access during normal working hours to all books, accounts, records, reports, files, financial records, supporting documentation, including payroll and accounts payable/receivable records, and other papers or property of Contractor for the purpose of auditing or inspecting any aspect of performance under this Contract. The inspection and/or audit will be confined to those matters connected with the performance of the Contract including, but not limited to, the costs of administering the Contract. The County will provide reasonable notice of such an audit or inspection. The County reserves the right to audit and verify the Contractor’s records before final payment is made. Contractor agrees to maintain such records for possible audit for a minimum of three years after final payment, unless a longer period of records retention is stipulated under this Contract or by law. Contractor agrees to allow interviews of any employees or others who might reasonably have information related to such records. Further, Contractor agrees to include a similar right to the County to audit records and interview staff of any subcontractor related to performance of this Contract. Should the Contractor cease to exist as a legal entity, the Contractor’s records pertaining to this Contract shall be forwarded to the County’s project manager.

  • Monitoring Compliance Upon the request of the Lender, but without incurring any liability beyond the Guaranteed Obligations, from time to time, Guarantor shall promptly provide to the Lender such documents, certificates and other information as may be deemed reasonably necessary to enable the Lender to perform its functions under the Servicing Agreement as the same relates to the Guarantor.

  • Reporting and Monitoring Please provide a brief description of the mechanisms proposed for this project for reporting to the UNDP and partners, including a reporting schedule.

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