Common use of IRO Review of Additional Items Clause in Contracts

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, policies, and procedures based on its review of each Additional Item).‌

IRO Review of Additional Items. ‌ As referenced set forth in Section III.E.2 III.E.1.b of the CIA, for each Reporting Period, 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 No later than 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Amgen Endo 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 Endo shall submit an audit work plan to the OIG for approval. The approval and the IRO shall conduct the review of the Additional Items based on a work plan approved by the 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 AmgenEndo’s systems, processes, policies, and procedures based on its review of each Additional Item).‌Item.) Endo may propose to the OIG that its internal audit(s) and/or reviews conducted as part of the Field Force Monitoring Program (FFMP) described in Section III.K of the CIA or the Non-Promotional Monitoring Program (NPMP) described in Section III.L of the CIA be substituted for one or more of the Additional Items that would otherwise be reviewed by the IRO for the applicable Reporting Period. The OIG retains sole discretion over whether, and in what manner, to allow Xxxx’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Xxxx’s planned monitoring activities and internal audit work, the results of the Transactions Review(s) during prior Reporting Period(s), and Xxxx’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Endo’s 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, Endo shall engage the IRO to perform the Review as outlined in this Section IV. If the OIG agrees to permit certain of Xxxx’s internal audit work for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work shall be subject to verification by the IRO (Verification Review). In such an instance, the OIG would provide additional details about the scope of the Verification Review to be conducted by the IRO. However, for purposes of any Verification Review, the IRO shall review at least 20% of the sampling units reviewed by Endo in its internal audits.

IRO Review of Additional Items. ‌ As referenced set forth in Section III.E.2 of the CIA, for the second through fifth each Reporting Periods Period, OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”). Amgen has represented thatThe Additional Items may include activities undertaken by Sanofi in connection with Promotional Functions, prior to the Effective Date as defined in Section II.C.3 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 through fifth 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 Items Review may include activities undertaken by conducted by Sanofi in connection with any Sanofi PAP, including the IRO and provision of free product to follow the process outlined abovepatients. If OIG determines it will not permit such substitution then, no No later than 120 150 days prior to the end of the applicable Reporting Period, OIG shall notify Amgen Sanofi 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 Sanofi 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 AmgenSanofi’s systems, processes, policies, and procedures based on its review of each Additional Item).‌Item). Sanofi may propose to OIG that relevant internal audit(s) and/or other reviews conducted by outside entities at Sanofi’s 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 Sanofi’s internal monitoring or audit work to be substituted for a portion of the Additional Items review conducted by the IRO.

IRO Review of Additional Items. ‌ As referenced set forth in Section III.E.2 of the CIA, for the second through fifth each Reporting Periods Period, OIG at its discretion may identify up to three additional items for the IRO to review (hereafter “Additional Items”). Amgen has represented thatThe Additional Items may include activities undertaken by Astellas in connection with Promotional Functions, prior to the Effective Date as defined in Section II.C.3 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 through fifth 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 Items Review may include activities undertaken by conducted by Astellas in connection with any Pharmaceutical Manufacturer PAP, including the IRO and provision of free product to follow the process outlined abovepatients. If OIG determines it will not permit such substitution then, no No later than 120 150 days prior to the end of the applicable Reporting Period, OIG shall notify Amgen Astellas 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 Astellas 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 Astellas’ systems, processes, policies, and procedures based on its review of each Additional Item).‌Item). Astellas may propose to OIG that relevant internal audit(s) and/or other reviews conducted by outside entities at Astellas’ 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 Astellas’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. In making its decision, XXX agrees to consider, among other factors, the nature and scope of Astellas’ planned monitoring activities and internal audit work, the results of the Transactions Review(s) during prior Reporting Period(s), and Astellas’ demonstrated audit capabilities to perform the proposed audit work internally. If OIG denies Astellas’ 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, Astellas shall engage the IRO to perform the Review as outlined in this Section IV.‌ If OIG agrees to permit certain of Astellas’ internal audit work for a given Reporting Period to be substituted for a portion of an Additional Items review, such internal work may be subject to verification by the IRO (Verification Review). In such an instance, OIG would provide additional details about the scope of the Verification Review to be conducted by the IRO.