Common use of System, Transaction, and Additional Items Reviews Clause in Contracts

System, Transaction, and Additional Items Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components: Systems Reviews and Transactions Reviews. The Systems Reviews shall assess Aegerion’s systems, processes, policies, and procedures relating to the Covered Functions and RAMP. If there are no material changes in Aegerion’s relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the second and fourth Reporting Periods. If Aegerion 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 second and fourth Reporting Periods, as set forth more fully in Appendix B. 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 Appendix B, the Transactions Review shall include several components. In addition, as set forth in Appendix B, each Transactions Review shall also include a review of up to three additional areas or practices of Aegerion identified by 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, OIG will consult with Aegerion and may consider internal audit and monitoring work conducted by Aegerion, the Government Reimbursed Product portfolio, the nature and scope of Aegerion’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, Aegerion may propose to 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. OIG retains sole discretion over whether, and in what manner, to allow Aegerion’s internal audit and monitoring work to be substituted for any portion of the Additional Items review conducted by the IRO. OIG shall notify Aegerion of the nature and scope of the IRO review for each of the Additional Items not later than 120 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or Aegerion shall submit an audit work plan to OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by OIG.

System, Transaction, and Additional Items Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components: Systems Reviews and Transactions ReviewsReviews relating to the Covered Functions. The Systems Reviews shall assess AegerionPfizer’s systems, processes, policies, and procedures relating to the Covered Functions and RAMPFunctions. If Except as otherwise set forth in Appendix B, if there are no material changes in AegerionPfizer’s relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the second first and fourth Reporting Periods. If Aegerion Pfizer 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 second first and fourth Reporting Periods, as set forth more fully in Appendix B. Corporate Integrity Agreement Pfizer Inc. The Transactions Reviews shall be performed annually and shall cover each of for the five second through fifth 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, as set forth in Appendix B, each Transactions Review shall also include a review of up to three additional areas or practices of Aegerion Pfizer identified by 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, OIG will consult with Aegerion Pfizer and may consider internal audit and monitoring work conducted by AegerionPfizer, the Government Reimbursed Product portfolio, the nature and scope of AegerionPfizer’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, Aegerion Pfizer may propose to OIG that its internal audit(s) or monitoring 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. OIG retains sole discretion over whether, and in what manner, to allow AegerionPfizer’s internal audit and monitoring work to be substituted for any portion of the Additional Items review conducted by the IRO. OIG shall notify Aegerion Pfizer of the nature and scope of the IRO review for each of the Additional Items not later than 120 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or Aegerion Pfizer shall submit an audit work plan to OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by OIG.

System, Transaction, and Additional Items Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components: Systems Reviews and Transactions ReviewsReviews relating to the Covered Functions and the RAMP. The Systems Reviews shall assess AegerionDaiichi’s systems, processes, policies, and procedures relating to the Covered Functions and the RAMP. If there are no material changes in AegerionDaiichi’s relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the second and fourth Reporting Periods. If Aegerion Daiichi 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 second and fourth Reporting Periods, as set forth more fully in Appendix B. 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 Appendix B, the Transactions Review shall include several components. In addition, as set forth in Appendix B, each Transactions Review shall also include a review of up to three additional areas or practices of Aegerion Daiichi 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 Aegerion Daiichi and may consider internal audit and monitoring work conducted by AegerionDaiichi, the Government Reimbursed Product portfolio, the nature and scope of AegerionDaiichi’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, Aegerion Daiichi 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 AegerionDaiichi’s internal audit and monitoring work to be substituted for any portion of the Additional Items review conducted by the IRO. The OIG shall notify Aegerion Daiichi of the nature and scope of the IRO review for each of the Additional Items not later than 120 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or Aegerion Daiichi shall submit an audit work plan to the OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by the OIG.

System, Transaction, and Additional Items Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components: Systems Reviews and Transactions Reviews. The Systems Reviews shall assess Aegerion’s United Therapeutics’ systems, processes, policies, and procedures relating to the Covered Functions Contribution and RAMPAssistance Related Functions. If there are no material changes in Aegerion’s United Therapeutics’ relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the second first and fourth Reporting Periods. If Aegerion United Therapeutics 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 second first and fourth Reporting Periods, as set forth more fully in Appendix B. The Transactions Reviews shall be performed annually and shall cover each of the five Reporting Periods. The Transactions Reviews shall assess Contribution and Assistance Related Functions and may assess Promotional Functions. 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, as set forth in Appendix B, each as part of the Transactions Review shall also include Reviews, OIG may at its discretion require a review of up to three additional areas or practices of Aegerion United Therapeutics identified by 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, OIG will consult with Aegerion United Therapeutics and may consider internal audit and monitoring work conducted by AegerionUnited Therapeutics, the Government Reimbursed Product portfolio, the nature and scope of Aegerion’s United Therapeutics’ promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, Aegerion United Therapeutics may propose to 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. OIG retains sole discretion over whether, and in what manner, to allow Aegerion’s United Therapeutics’ internal audit and monitoring work to be substituted for any portion of the Additional Items review conducted by the IRO. OIG shall notify Aegerion United Therapeutics of the nature and scope of the IRO review for each of the Additional Items not later than 120 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or Aegerion United Therapeutics shall submit an audit work plan to OIG for approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by OIG.