Inspection and Debarment Sample Clauses

Inspection and Debarment. When given reasonable notice, the Site agrees to allow authorized Quintiles, Sponsor or regulatory authority personnel direct access to the Site’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. The Site shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Site’s facilities, and the Site shall permit Quintiles and Sponsor to attend any such inspections. The Site will make reasonable efforts to separate, and not disclose, all confidential materials that are not required to be disclosed during such inspections. The Investigator and the Institution, if any, shall be jointly responsible for maintaining essential Study documents for the time and in the manner specified by current good clinical practice (“GCP”) guidelines, local laws, and Sponsor requirements and shall take measures to prevent accidental or premature destruction of these documents. If the Investigator leaves an institution, then responsibility for maintaining Study records shall be determined in accordance with applicable regulations. If an investigator or subinvestigator leaves an institution or otherwise changes addresses, he or she shall promptly notify Sponsor and Quintiles of his or her new address. The Site represents and warrants that neither it, nor any of its employees, agents or other persons performing the Study under its direction, has been debarred, disqualified or banned from conducting clinical trials or is under investigation by any regulatory authority for debarment or any similar regulatory action in any country, and the Site shall notify Quintiles immediately if any such investigation, disqualification, debarment, or ban occurs.
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Inspection and Debarment. When given reasonable notice, the Institution agrees to allow authorized PRA, Sponsor or regulatory authority personnel direct access to the Institution’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. Unless prohibited by legislation or decision of a public authority, the Institution shall immediately notify PRA of, and provide PRA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit PRA and Sponsor to attend any such inspections. The Site will permit the Sponsor to comment in advance, when practicable, on any correspondence to a governmental or regulatory authority. The
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Inspection and Debarment. When given reasonable notice, the Institution agrees to allow authorized PRA, Sponsor or regulatory authority personnel direct access to the Institution’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. The Institution shall immediately notify PRA of, and provide PRA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit PRA and Sponsor to attend any such inspections. The Site will permit the Sponsor to comment in advance, when practicable, on any correspondence to a governmental or regulatory authority. The Institution will make reasonable efforts to separate, and not disclose, all confidential materials that are not required to be disclosed during such inspections. The Institution shall promptly take steps to correct any deficiencies found by any such audit or inspection by PRA, Sponsor or a regulatory authority. The Institution, shall be responsible for maintaining essential Study documents for 15 years after completing the Study and in the manner specified by current good clinical practice (“GCP”) guidelines, local laws, and Sponsor requirements and shall take measures to prevent accidental or premature destruction of these documents. If the Principal Investigator or sub-Investigator ceases to work in the Institution or otherwise changes addresses, or if he or she ceases to be an employee of Institution or is no longer able or willing to participate in the Study, the Institution shall immediately after such finding, notify PRA and Sponsor and provide them with actual address of the Principle Investigator and Sub-Investigators. PRA reserves the right to approve any replacement Principal Investigator. The Institution represents and warrants that neither it, nor, to its best knowledge, any of its employees, agents or other persons performing the Study under its direction, has been debarred,
Sample 1
Inspection and Debarment. When given reasonable notice, the Site agrees to allow authorized PRA, Sponsor or regulatory authority personnel direct access to the Site’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. The Institution shall immediately notify PRA of, and provide PRA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit PRA and Sponsor to attend any such inspections. Sponsor and/or PRA shall notify Site (Clinical studies department) on any dates of scheduled initiatory, close out and
Sample 1
Inspection and Debarment. When given reasonable notice, the Site agrees to allow authorized Quintiles, Sponsor or regulatory authority personnel direct access to the Site’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes and to all facilities used by Site to conduct the Study. The Site shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Site’s facilities, and the Site shall permit Quintiles and Sponsor to attend any such inspections. The Site will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections. Quintiles and/or AstraZeneca shall have the right to review and approve in advance any responses that pertain to the Study. No such response shall contain any false or misleading information with respect to the Study, the Investigational Product, Quintiles or AstraZeneca. For fifteen (15) years after the completion by Institution and Investigator of all obligations in the conduct of the Study, or the early termination of the Study, the Institution and the Investigator shall prepare, maintain and retain complete, current, accurate, organized and legible Study Documentation and medical records of all subjects in a manner acceptable for the collection of data for submission to, or review by, the FDA and other regulatory or governmental authorities, and in full compliance with the Protocol and all Applicable Laws and shall take measures to prevent accidental or premature destruction of these documents. If the Investigator leaves an institution, then responsibility for maintaining Study records shall be determined in accordance with applicable regulations. If Investigator or a sub-investigator leaves an institution or otherwise changes addresses, he or she
Sample 1
Inspection and Debarment. When given reasonable notice, the Institution agrees to allow authorized IQVIA, Sponsor and regulatory authority personnel direct access to the Institution’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. If any source data are kept on computer files only, the Site shall make print-outs of all such data relevant to the Study for the purpose of source data verification, and shall have them signed, dated and retained as source documents. The Institution shall immediately notify IQVIA of, and provide IQVIA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit IQVIA and Sponsor to attend any such inspections. The Institution will make reasonable efforts to
Sample 1
Inspection and Debarment. Upon ten (10) business days’ prior written notice, Biotest agrees to provide Derma Sciences with access to Biotest’s records relating to the Clinical Services during normal business hours and at any of Biotest’s facilities where the documents are present, including the subject medical records, for monitoring, auditing, and inspection purposes. Further, Biotest shall immediately notify Derma Sciences, and provide copies, of any inquiries, correspondence or communications from any government or regulatory authority relating to the Clinical Services, including, but not limited to, requests for inspection. With respect to this latter, Biotest shall permit Derma Sciences to attend any such inspections. Biotest represents and warrants that, to its actual knowledge, neither it nor any of its employees, agents or other persons performing the Clinical Services is under investigation by any regulatory authority for debarment or any similar regulatory action in any country and Biotest shall immediately notify Derma Sciences if any such investigation, disqualification, debarment or ban occurs.
Sample 1
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Related to Inspection and Debarment

  • Investigation and Prevention DST shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to: (A) cooperate with Fund in its efforts to comply with statutory notice or other legal obligations applicable to Fund or its clients arising out of unauthorized access and to seek injunctive or other equitable relief; (B) cooperate with Fund in litigation and investigations against third parties reasonably necessary to protect its proprietary rights; and (C) take reasonable actions necessary to mitigate loss from any such authorized access.

  • Suspension and Debarment Contractor certifies that it and its principals are not suspended or debarred from doing business with the state or federal government as listed on the State of Texas Debarred Vendor List maintained by the Texas Comptroller of Public Accounts and the System for Award Management (XXX) maintained by the General Services Administration. This certification is made pursuant to the regulations implementing Executive Order 12549 and Executive Order 12689, Debarment and Suspension, 2 C.F.R. Part 376, and any relevant regulations promulgated by the Department or Agency funding this project. This provision shall be included in its entirety in Contractor’s subcontracts, if any, if payment in whole or in part is from federal funds.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

  • INSPECTION AND REJECTION 8.1 Purchaser shall have the right to inspect and test Products at any time prior to shipment, and within a reasonable time after delivery to the Purchaser’s Destination. Products not inspected within a reasonable time after delivery shall be deemed accepted by Purchaser. The payment for Products shall in no way impair the right of Purchaser to reject nonconforming Products, or to avail itself of any other remedies to which it may be entitled. 8.2 If any of the Products are found at any time to be defective in material or workmanship, damaged, or otherwise not in conformity with the requirements of this Agreement or any applicable Purchase Order, as its exclusive remedy, Purchaser may at its option and at Vendor’s sole cost and expense, elect either to (i) return any damaged, non-conforming or defective Products to Vendor for correction or replacement, or (ii) require Vendor to inspect the Products and remove or replace damaged, non-conforming or defective Products with conforming Products. If Purchaser elects option (ii) in the preceding sentence and Vendor fails promptly to make the necessary inspection, removal and replacement, Purchaser, at its option, may inspect the Products and Vendor shall bear the cost thereof. Payment by Purchaser of any invoice shall not constitute acceptance of the Products covered by such invoice, and acceptance by Purchaser shall not relieve Vendor of its warranties or other obligations under this Agreement. 8.3 The provisions of this Article shall survive the expiration or termination of this Agreement.

  • Inspection and Verification The Secured Parties and such persons as the Secured Parties may reasonably designate shall have the right to inspect the Collateral, all records related thereto (and to make extracts and copies from such records) and the premises upon which any of the Collateral is located, to discuss the Grantor’s affairs with the officers of the Grantor and its independent accountants and to verify under reasonable procedures the validity, amount, quality, quantity, value, condition and status of, or any other matter relating to, the Collateral, including, in the case of collateral in the possession of any third Person, by contacting any account debtor or third Person possessing such Collateral for the purpose of making such a verification. Out-of-pocket expenses in connection with any inspections by representatives of the Secured Parties shall be (a) the obligations of the Grantor with respect to any inspection after the Secured Parties’ demand payment of the Notes or (b) the obligation of the Secured Parties in any other case.

  • Books and Records; Inspection and Examination The Borrower will keep accurate books of record and account for itself pertaining to the Collateral and pertaining to the Borrower's business and financial condition and such other matters as the Lender may from time to time request in which true and complete entries will be made in accordance with GAAP and, upon the Lender's request, will permit any officer, employee, attorney or accountant for the Lender to audit, review, make extracts from or copy any and all corporate and financial books and records of the Borrower at all times during ordinary business hours, to send and discuss with account debtors and other obligors requests for verification of amounts owed to the Borrower, and to discuss the Borrower's affairs with any of its directors, officers, employees or agents. The Borrower will permit the Lender, or its employees, accountants, attorneys or agents, to examine and inspect any Collateral, other collateral covered by the Security Documents or any other property of the Borrower at any time during ordinary business hours.

  • Examination and Review (i) After receipt of the Closing Working Capital Statement, Seller will have *** (***) days from the date on which Buyer has provided to Seller all access and information reasonably requested for such purposes (the “Review Period”) to review the Closing Working Capital Statement. During the Review Period, Seller and its accountants will have full access to the relevant books and records of Buyer, the personnel of, and work papers prepared by, Buyer and/or Buyer’s accountants to the extent that they relate to the Closing Working Capital Statement and to such historical financial information (to the extent in Buyer’s possession) relating to the Closing Working Capital Statement as Seller may reasonably request for the purpose of reviewing the Closing Working Capital Statement and to prepare a Statement of Objections. (ii) On or prior to the last day of the Review Period, Seller may object to the Closing Working Capital Statement by delivering to Buyer a written statement setting forth Seller’s objections in reasonable detail, indicating each disputed item or amount and the basis for Seller’s disagreement therewith (the “Statement of Objections”). If Seller fails to deliver the Statement of Objections before the expiration of the Review Period, then the Closing Working Capital Statement and the Post-Closing Adjustment, as the case may be, reflected in the Closing Working Capital Statement will be deemed to have been accepted by Seller. If Seller delivers the Statement of Objections before the expiration of the Review Period, Buyer and Seller will negotiate in good faith to resolve such objections within *** (***) days after the delivery of the Statement of Objections (the “Resolution Period”), and, if the same are so resolved within the Resolution Period, then the Post-Closing Adjustment and the Closing Working Capital Statement with such changes as may have been previously agreed in writing by Buyer and Seller, will be final and binding.

  • Audit, Inspection and Visitation The Adviser shall make available to the Trust during regular business hours all records and other data created and maintained pursuant to the foregoing provisions of this Agreement for reasonable audit and inspection by the Trust or any regulatory agency having authority over the Trust.

  • Contractor Responsibility and Debarment The following requirements set forth in the County’s Non-Responsibility and Debarment Ordinance (Title 2, Chapter 2.202 of the County Code) are effective for this Agreement, except to the extent applicable State and/or federal laws are inconsistent with the terms of the Ordinance. A. A responsible Contractor is a Contractor who has demonstrated the attribute of trustworthiness, as well as quality, fitness, capacity and experience to satisfactorily perform the contract. It is the County’s policy to conduct business only with responsible contractors. B. The Contractor is hereby notified that, in accordance with Chapter 2.202 of the County Code, if the County acquires information concerning the performance of the Contractor on this or other Agreements which indicates that the Contractor is not responsible, the County may, in addition to other remedies provided in the Agreement, debar the Contractor from bidding or proposing on, or being awarded, and/or performing work on County Agreements for a specified period of time, which generally will not exceed five years but may exceed five years or be permanent if warranted by the circumstances, and terminate any or all existing Agreements the Contractor may have with the County. C. The County may debar a Contractor if the Board of Supervisors finds, in its discretion, that the Contractor has done any of the following: (1) violated a term of an Agreement with the County or a nonprofit corporation created by the County; (2) committed an act or omission which negatively reflects on the Contractor’s quality, fitness or capacity to perform a contract with the County, any other public entity, or a nonprofit corporation created by the County, or engaged in a pattern or practice which negatively reflects on same; (3) committed an act or offense which indicates a lack of business integrity or business honesty, or (4) made or submitted a false claim against the County or any other public entity. D. If there is evidence that the Contractor may be subject to debarment, the Department will notify the Contractor in writing of the evidence which is the basis for the proposed debarment and will advise the Contractor of the scheduled date for a debarment hearing before the Contractor Hearing Board. E. The Contractor Hearing Board will conduct a hearing where evidence on the proposed debarment is presented. The Contractor and/or the Contractor’s representative shall be given an opportunity to submit evidence at that hearing. After the hearing, the Contractor Hearing Board shall prepare a tentative proposed decision, which shall contain a recommendation regarding whether the contractor should be debarred, and, if so, the appropriate length of time of the debarment. The Contractor and the Department shall be provided an opportunity to object to the tentative proposed decision prior to its presentation to the Board of Supervisors. F. After consideration of any objections, or if no objections are submitted, a record of the hearing, the proposed decision and any other recommendation of the Contractor Hearing Board shall be presented to the Board of Supervisors. The Board of Supervisors shall have the right to modify, deny or adopt the proposed decision and recommendation of the Hearing Board. G. If a Contractor has been debarred for a period longer than five (5) years, that Contractor may, after the debarment has been in effect for at least five (5) years, submit a written request for review of the debarment determination to reduce the period of debarment or terminate the debarment. The County may, in its discretion, reduce the period of debarment or terminate the debarment if it finds that the Contractor has adequately demonstrated one or more of the following: (1) elimination of the grounds for which the debarment was imposed; (2) a bona fide change in ownership or management; (3) material evidence discovered after debarment was imposed; or (4) any other reason that is in the best interests of the County. H. The Contractor Hearing Board will consider a request for review of a debarment determination only where (1) the Contractor has been debarred for a period longer than five (5) years; (2) the debarment has been in effect for at least five (5) years; and (3) the request is in writing, states one or more of the grounds for reduction of the debarment period or termination of the debarment, and includes supporting documentation. Upon receiving an appropriate request, the Contractor Hearing Board will provide notice of the hearing on the request. At the hearing, the Contractor Hearing Board shall conduct a hearing where evidence on the proposed reduction of debarment period or termination of debarment is presented. This hearing shall be conducted and the request for review decided by the Contractor Hearing Board pursuant to the same procedures as for a debarment hearing. I. The Contractor Hearing Board’s proposed decision shall contain a recommendation on the request to reduce the period of debarment or terminate the debarment. The Contractor Hearing Board shall present its proposed decision and recommendation to the Board of Supervisors. The Board of Supervisors shall have the right to modify, deny, or adopt the proposed decision and recommendation of the Contractor Hearing Board. J. These terms shall also apply to subcontractors of County Contractors.

  • Survival Regardless of Investigation The indemnification and contribution provided for herein will remain in full force and effect regardless of any investigation made by or on behalf of Indemnitee or any officer, director, employee, agent or controlling person of Indemnitee.

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