Obligations Regarding IRB Review/Decisions Sample Clauses

Obligations Regarding IRB Review/Decisions. 1. FWA; Central IRB Review in Accordance with FWA. ABC will maintain a current, approved FWA with OHRP for the duration of this Agreement. ABC will notify the Central IRB (via the NCRI CCC) promptly in writing if its FWA is threatened, terminated, or expires for any reason. The Central IRB will perform initial review and continuing oversight of the Clinical Studies included in this Agreement in accordance with the human subjects protection requirements of ABC’s OHRP- approved FWA and the federal regulations and ethical principles referenced therein. Review by the Central IRB will take into account the requirements of the local research context identified by ABC pursuant to the Reliance SOP and Sections II.2(b) and III.4 of this Agreement. ABC shall provide a copy of its FWA to the Central IRB (via the NCRI CCC) with the NEALS Member IRB Information Sheet and thereafter upon any material change or renewal. Material change includes, but is not limited to, a change in the components of ABC that are covered under the FWA.
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Obligations Regarding IRB Review/Decisions. 1. FWA; Central IRB Review in Accordance with FWA. ABC will maintain a current, approved FWA with OHRP for the duration of this Agreement. ABC will notify the Central IRB (via the NeuroNEXT CCC) promptly in writing if its FWA is threatened, terminated, or expires for any reason. The Central IRB will perform initial review and continuing oversight of the Clinical Studies included in this Agreement in accordance with the human subjects protection requirements of ABC’s OHRP- approved FWA and the federal regulations and ethical principles referenced therein. Review by the Central IRB will take into account the requirements of the local research context identified by ABC pursuant to the Reliance SOP and Sections II.2(b) and III.4 of this Agreement. ABC shall provide a copy of its FWA to the Central IRB (via the NeuroNEXT CCC) with the NeuroNEXT Clinical Study Site IRB Information Sheet and thereafter upon any material change or renewal. Material change includes, but is not limited to, a change in the components of ABC that are covered under the FWA.
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Related to Obligations Regarding IRB Review/Decisions

  • ADB’s Review of Procurement Decisions 11. All contracts procured under international competitive bidding procedures and contracts for consulting services shall be subject to prior review by ADB, unless otherwise agreed between the Borrower and ADB and set forth in the Procurement Plan. SCHEDULE 5 Execution of Project and Operation of Project Facilities; Financial Matters

  • Expectations Regarding Advance Notices Within ten (10) days after the commencement of each calendar quarter occurring subsequent to the commencement of the Commitment Period, the Company must notify the Investor, in writing, as to its reasonable expectations as to the dollar amount it intends to raise during such calendar quarter, if any, through the issuance of Advance Notices. Such notification shall constitute only the Company's good faith estimate and shall in no way obligate the Company to raise such amount, or any amount, or otherwise limit its ability to deliver Advance Notices. The failure by the Company to comply with this provision can be cured by the Company's notifying the Investor, in writing, at any time as to its reasonable expectations with respect to the current calendar quarter.

  • Completion of Review for Certain Review Receivables Following the delivery of the list of the Review Receivables and before the delivery of the Review Report by the Asset Representations Reviewer, the Servicer may notify the Asset Representations Reviewer if a Review Receivable is paid in full by the Obligor or purchased from the Issuer in accordance with the terms of the Basic Documents. On receipt of such notice, the Asset Representations Reviewer will immediately terminate all Tests of the related Review Receivable, and the Review of such Review Receivables will be considered complete (a “Test Complete”). In this case, the related Review Report will indicate a Test Complete for such Review Receivable and the related reason.

  • Review by the Bank of Procurement Decisions The Procurement Plan shall set forth those contracts which shall be subject to the Bank’s Prior Review. All other contracts shall be subject to Post Review by the Bank.

  • REVIEW OF CONTRACT DOCUMENTS 4.2.1 The Contractor shall carefully study and compare the Contract Documents and shall immediately report in writing to the Architect and the State any error, inconsistency or omission he may discover. The Contractor shall not be liable to the State or the Architect for any damage resulting from any such errors, inconsistencies or omissions in the Contract Documents. The Contractor shall perform no portion of the Work at any time without Contract Documents or, where required, approved Shop Drawings, Product Data or Samples for such portion of the Work.

  • Review by the World Bank of Procurement Decisions The Procurement Plan shall set forth those contracts which shall be subject to the World Bank’s Prior Review. All other contracts shall be subject to Post Review by the World Bank.

  • Limitations on Review Obligations The Asset Representations Reviewer may rely on the information in any Review Notice, the list(s) of the Subject Receivables provided by the Servicer, and the accuracy and completeness of the Review Materials. The Asset Representations Reviewer will have no obligation:

  • 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.

  • Completion of Review for Certain Subject Receivables Following the delivery of the list of the Subject Receivables and before the delivery of the Review Report by the Asset Representations Reviewer, the Servicer may notify the Asset Representations Reviewer if a Subject Receivable is paid in full by or on behalf of the Obligor or purchased from the Issuer by the Sponsor or the Servicer in accordance with the Transaction Documents. On receipt of notice, the Asset Representations Reviewer will immediately terminate all Tests of such Receivables and the Asset Review of such Receivables will be considered complete (a “Test Complete”). In this case, the Review Report will indicate a Test Complete for the Receivables and the related reason.

  • Directions Regarding Periodic Payments As registered owner of the Funding Agreement and the Guarantee as collateral securing payments on the Notes, the Indenture Trustee will receive payments on the Funding Agreement and the Guarantee on behalf of the Trust. The Trust hereby directs the Indenture Trustee to use such funds to make payments on behalf of the Trust pursuant to the Trust Agreement and the Indenture.

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