IRO Review of Additional Items Sample Clauses

IRO Review of Additional Items. As set forth in Section III.E.2.c of the CIA, for each Reporting Period, the OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”).
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IRO Review of Additional Items. ‌ As referenced in Section III.E.2 of the CIA, for the second through fifth Reporting Periods OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”). Amgen has represented that, prior to the Effective Date of the CIA, Amgen established an annual external review process through which Amgen engages an outside entity to review and make findings regarding certain aspects of its operations (the “External Reviews”). For at least the second Reporting Period, OIG agrees to permit these External Reviews to be substituted for any Additional Items reviews by an IRO that would otherwise be required under this Section IV.B of Appendix B. At least 60 days prior to the end of the second Reporting Period, Amgen shall provide to OIG a list of all External Reviews completed in that Reporting Period. OIG may select up to three of the External Reviews and shall notify Amgen of its selection at least 30 days prior to the end of the second Reporting Period. For each External Review selected by the OIG, Amgen shall include the following information in its Annual Report for the second Reporting Period: (1) complete copies of any written reports produced as a result of the External Review, including any findings and recommendations; and (2) Amgen’s response and corrective action plan relating to any findings and recommendations set forth in the External Review report. For subsequent Reporting Periods, OIG shall retain sole discretion over whether to continue to permit Xxxxx’s External Reviews to be substituted for one or more of the Additional Item reviews that would otherwise by conducted by the IRO and to follow the process outlined above. If OIG determines it will not permit such substitution then, no later than 120 days prior to the end of the applicable Reporting Period, OIG shall notify Amgen of the nature and scope of the IRO review to be conducted for each of the Additional Items. Prior to undertaking the review of the Additional Items, the IRO shall submit an audit work plan to OIG for approval. The IRO shall conduct the review of the Additional Items based on a work plan approved by OIG. The IRO shall include information about its review of each Additional Item in the Transactions Review Report (including a description of the review conducted for each Additional Item; the IRO’s findings based on its review for each Additional Item; and the IRO’s recommendations for any changes in Amgen’s systems, processes, po...
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IRO Review of Additional Items. As set forth in Section III.E.2 of the CIA, for each Reporting Period, OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”). The Additional Items may include activities undertaken by United Therapeutics in connection with Promotional Functions, as defined in Section II.C.3 of the CIA. For the second through fifth Reporting Periods, the Additional Items Review may include activities undertaken by United Therapeutics in connection with any Pharmaceutical Manufacturer PAP, including the provision of free product to patients. No later than 150 days prior to the end of the applicable Reporting Period, OIG shall notify United Therapeutics of the nature and scope of the IRO review to be conducted for each of the Additional Items. Prior to undertaking the review of the Additional Items, the IRO and/or United Therapeutics shall submit an audit work plan to OIG for approval. The IRO shall conduct the review of the Additional Items based on a work plan approved by OIG. The IRO shall include information about its review of each Additional Item in the Transactions Review Report (including a description of the review conducted for each Additional Item; the IRO’s findings based on its review for each Additional Item; and the IRO’s recommendations for any changes in United Therapeutics’ systems, processes, policies, and procedures based on its review of each Additional Item). United Therapeutics may propose to OIG that relevant internal audit(s) and/or other reviews conducted by outside entities at United Therapeutics’ request be substituted for one or more of the Additional Item reviews that would otherwise be conducted by the IRO for the applicable Reporting Period. OIG retains sole discretion over whether, and in what manner, to allow United Therapeutics’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. In making its decision, OIG agrees to consider, among other factors, the nature and scope of United Therapeutics’ planned monitoring activities and internal audit work, the results of the Transactions Review(s) during prior Reporting Period(s), and United Therapeutics’ demonstrated audit capabilities to perform the proposed audit work internally. If OIG denies United Therapeutics’ request to permit its internal audit work to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, United Therapeutics shall engag...
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Related to IRO Review of Additional Items

  • 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 of Servicer’s Records The Servicer will maintain records and documents relating to its performance under this Agreement according to its customary business practices. On reasonable request not more than once during any year, the Servicer will give the Issuer, the Depositor, the Administrator, the Owner Trustee and the Indenture Trustee (or their representatives) access to the records and documents to conduct a review of the Servicer’s performance under this Agreement. Any access or review will be conducted at the Servicer’s offices during its normal business hours at a time reasonably convenient to the Servicer and in a manner that will minimize disruption to its business operations. Any access or review will be subject to the Servicer’s confidentiality and privacy policies.

  • Agent’s Review of Proposed Amendments and Supplements Prior to amending or supplementing the Registration Statement (including any registration statement filed under Rule 462(b) under the Securities Act) or the Prospectus (excluding any amendment or supplement through incorporation of any report filed under the Exchange Act), the Company shall furnish to the Agent for review, a reasonable amount of time prior to the proposed time of filing or use thereof, a copy of each such proposed amendment or supplement, and the Company shall not file or use any such proposed amendment or supplement without the Agent’s prior consent, and to file with the Commission within the applicable period specified in Rule 424(b) under the Securities Act any prospectus required to be filed pursuant to such Rule.

  • Periodic Review of Costs of Environmental Compliance In the ordinary course of its business, the Company conducts a periodic review of the effect of Environmental Laws on the business, operations and properties of the Company and its subsidiaries, in the course of which it identifies and evaluates associated costs and liabilities (including, without limitation, any capital or operating expenditures required for clean-up, closure of properties or compliance with Environmental Laws or any permit, license or approval, any related constraints on operating activities and any potential liabilities to third parties). On the basis of such review and the amount of its established reserves, the Company has reasonably concluded that such associated costs and liabilities would not, individually or in the aggregate, result in a Material Adverse Change.

  • Review Procedures The Parties agree to jointly conduct a review, sampling transactions of the incidents managed under this Agreement. Findings that are inconsistent with the normal or accepted way of doing business will be reconciled on a case by case basis. Any decision to further examine records will be considered on a case by case basis and appropriate follow up action agreed upon by all agencies involved. Payment for Protection Services (use if appropriate) Geographic, Statewide or Sub-Geographic (local) operating plans and procurement documents or agreement will establish billing procedures for Fee Basis Protection Services.

  • IMPORTANT INFORMATION ABOUT PROCEDURES FOR OPENING A NEW ACCOUNT To help the government fight the funding of terrorism and money laundering activities, Federal law requires all financial organizations to obtain, verify, and record information that identifies each person who opens an account. What this means for you: When you open an account, you are required to provide your name, residential address, date of birth, and identification number. We may require other information that will allow us to identify you.

  • Review Procedure If the Plan Administrator denies part or all of the claim, the claimant shall have the opportunity for a full and fair review by the Plan Administrator of the denial, as follows:

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