Frequency and Brief Description of Reviews Sample Clauses

Frequency and Brief Description of Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AstraZeneca’s systems, processes, policies, and procedures relating to Promotional Functions and Product Related Functions. If there are no material changes in AstraZeneca’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of AstraZeneca identified by the OIG in its discretion (hereafter “Additional Items”). For purposes of identifying the Additional Items to be included in the Transactions Review for a particular Reporting Period, the OIG will consult with AstraZeneca and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZeneca, the Government Reimbursed Product portfolio, the nature and scope of AstraZeneca’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca may propose to the OIG that its internal audit(s) be partially substituted for one or more of the Additional Items that would otherwise be reviewed by the IRO as part of the Transactions Review. The OIG retains sole discretion over whether, and in what manner, to allow AstraZeneca’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca of the nature and scope of the IRO review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca shall submit an audit work plan to the OIG for approval and the...
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Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and C, the IRO Reviews shall consist of three components: (1) Systems Reviews and Transactions Reviews relating to the Covered Functions; (2) Additional Items reviews; and
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Frequency and Brief Description of Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components – a Systems Review and an Encounters Review, or an Alternate Review in lieu of an Encounters Review, as provided for in Section I.C of Appendix B. The Systems Review shall assess EGS’s systems, processes, policies, and procedures relating to 1) Promotional Functions;
Sample 1
Frequency and Brief Description of Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess Biovail’s systems, processes, policies, and procedures relating to the Medicaid Drug Rebate Program and the reporting of ASP for purposes of the Medicare Program and certain elements of Biovail’s Promotional and Product Services Related Functions (Systems Review). As set forth in Appendix B, if there are no material changes in Biovail’s relevant systems, processes, policies, and procedures, the Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If Biovail materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods. The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods.
Sample 1
Frequency and Brief Description of Reviews. (i) System, Transaction, and Additional Items Reviews. As set forth more fully in Appendices B and C, the IRO Reviews shall consist of two components: Systems Reviews and Transactions Reviews relating to the Promotional and Product Services Related Functions and the ERM Program. The Systems Reviews shall assess Baxano Surgical’s systems, processes, policies, and procedures relating to the Promotional and Product Services Related Functions and ERM Program. If there are no material changes in Baxano Surgical’s relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the periods covering the first and fourth Reporting Periods. If Baxano Surgical materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendices B and C. The Transactions Reviews shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and C, the Transactions Review shall include several components.
Sample 1
Frequency and Brief Description of Reviews. As set forth more fully in Appendix B, the Promotional and Product Services Review shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AtriCure, Inc.’s systems, processes, policies, and procedures relating to Promotional and Product Services Related Functions. If there are no material changes in AtriCure, Inc.’s systems, processes, policies, and procedures relating to Promotional and Product Services Related Functions, the Promotional and Product Services Systems Review shall be performed for the periods covering the first and fourth CORPORATE INTEGRITY AGREEMENT ATRICURE, INC.
Sample 1

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