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 United Therapeutics’ systems, processes, policies, and procedures relating to the Contribution and Assistance Related Functions. If there are no material changes in United Therapeutics’ relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the first and fourth Reporting Periods. If 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 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, as part of the Transactions Reviews, OIG may at its discretion require a review of up to three additional areas or practices of 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 United Therapeutics and may consider internal audit and monitoring work conducted by United Therapeutics, the Government Reimbursed Product portfolio, the nature and scope of United Therapeutics’ promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, 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 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 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 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.

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 United Therapeutics’ Pfizer’s systems, processes, policies, and procedures relating to the Contribution and Assistance Related Covered Functions. If Except as otherwise set forth in Appendix B, if there are no material changes in United Therapeutics’ Pfizer’s relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the first and fourth Reporting Periods. If United Therapeutics 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 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 for the five second through fifth 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, as part of the each Transactions Reviews, OIG may at its discretion require Review shall also include a review of up to three additional areas or practices of United Therapeutics 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 United Therapeutics Pfizer and may consider internal audit and monitoring work conducted by United TherapeuticsPfizer, the Government Reimbursed Product portfolio, the nature and scope of United Therapeutics’ Pfizer’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, United Therapeutics 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 United Therapeutics’ Pfizer’s internal audit and monitoring work to be substituted for any portion of the Additional Items review conducted by the IRO. OIG shall notify United Therapeutics 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 United Therapeutics 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 United Therapeutics’ Daiichi’s systems, processes, policies, and procedures relating to the Contribution Covered Functions and Assistance Related Functionsthe RAMP. If there are no material changes in United Therapeutics’ Daiichi’s relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the first second and fourth Reporting Periods. If United Therapeutics 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 first 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 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, as part of the each Transactions Reviews, OIG may at its discretion require Review shall also include a review of up to three additional areas or practices of United Therapeutics 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 United Therapeutics Daiichi and may consider internal audit and monitoring work conducted by United TherapeuticsDaiichi, the Government Reimbursed Product portfolio, the nature and scope of United Therapeutics’ Daiichi’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, United Therapeutics 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 United Therapeutics’ Daiichi’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 United Therapeutics 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 United Therapeutics 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 United Therapeutics’ Aegerion’s systems, processes, policies, and procedures relating to the Contribution Covered Functions and Assistance Related FunctionsRAMP. If there are no material changes in United Therapeutics’ Aegerion’s relevant systems, processes, policies, and procedures, the Systems Reviews shall be performed for the first second and fourth Reporting Periods. If United Therapeutics 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 first 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 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, as part of the each Transactions Reviews, OIG may at its discretion require Review shall also include a review of up to three additional areas or practices of United Therapeutics 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 United Therapeutics Aegerion and may consider internal audit and monitoring work conducted by United TherapeuticsAegerion, the Government Reimbursed Product portfolio, the nature and scope of United Therapeutics’ Aegerion’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, United Therapeutics 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 United Therapeutics’ 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 United Therapeutics 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 United Therapeutics 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.