Common use of IRO Review of Additional Items Clause in Contracts

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”). 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior 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 Indivior 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. 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 Indivior’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request be substituted, subject to the Verification Review requirements set forth below, 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 Indivior’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Indivior’s planned internal audit work or compliance monitoring or audit activities, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior shall engage the IRO to perform the Review as outlined in this Section III.E.

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”). 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior 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 Indivior 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. 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 Indivior’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request be substituted, subject to the Verification Review requirements set forth below, 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 Indivior’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Indivior’s planned internal audit work or compliance monitoring or audit activities, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior shall engage the IRO to perform the Review as outlined in this Section III.E. 4. If the OIG agrees to permit certain of Indivior’s internal audit work or compliance monitoring or audit activities for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would 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.

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E.2 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”). 1. ) If during the term of the CIA, Aegerion enters arrangements with (including donation funding of, sponsorship, or contributions to) any independent third-party patient assistance program, such arrangements will be subject to an IRO review under this Section IV.C. No later than 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Aegerion 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 Indivior Aegerion 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. 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 IndiviorAegerion’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior ) Aegerion may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those ) and/or reviews conducted as part of the Field Force Monitoring Program (FFMP) described in Section III.L of the CIA or the Monitoring of Non-Promotional Activities Monitoring Program (NPMP) described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request be substituted, subject to the Verification Review requirements set forth below, substituted for one or more of the Additional Items Item reviews that would otherwise be reviewed conducted by the IRO for the applicable Reporting Period. The OIG retains sole discretion over whether, and in what manner, to allow IndiviorAegerion’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorAegerion’s planned monitoring activities and internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and IndiviorAegerion’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorAegerion’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Aegerion shall engage the IRO to perform the Review as outlined in this Section III.E.IV. If the OIG agrees to permit certain of Aegerion’s internal audit work for a given Reporting Period to be substituted for a portion of an 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 Aegerion in its internal audits.

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E.1.b 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”). 1. ) No later than 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior 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 Indivior Endo 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. 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 IndiviorEndo’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior ) Endo may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those ) 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 or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request be substituted, subject to the Verification Review requirements set forth below, 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 IndiviorXxxx’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorXxxx’s planned monitoring activities and internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and IndiviorXxxx’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorEndo’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Endo shall engage the IRO to perform the Review as outlined in this Section III.E.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 set forth in Section III.E.2.c III.E.2 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”).Items”).‌ 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Taro 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 Indivior Taro shall submit an audit work plan to the OIG for approval and review and, absent any objection from the OIG, the IRO shall conduct the review of the Additional Items based on a the work plan approved by the OIGplan. 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 IndiviorTaro’s systems, processes, policies, and procedures based on its review of each Additional Item).Item).‌ 2. Indivior Taro may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those ) and/or review(s) conducted as part of the Field Force Internal Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M Section‌ III.K of the CIA and/or other reviews conducted by both internal and outside entities at IndiviorXxxx’s request be substituted, subject to the Verification Review requirements set forth below, 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 IndiviorXxxx’s internal audit work or monitoring and/or other reviews conducted by outside entities to be substituted for a portion of the Additional Items review conducted by the IRO.IRO.‌‌ 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorXxxx’s planned internal monitoring activities and audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and IndiviorXxxx’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorTaro’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Taro shall engage the IRO to perform the Review as outlined in this Section III.E.III.B.‌ 4. If the OIG agrees to permit certain of Xxxx’s monitoring, internal audit work, or other reviews for a given Reporting Period to be substituted for a portion of Additional Items review, such work would 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.‌

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”). 1. No later than 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Novartis 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 Indivior Novartis 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. 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 Indivior’s Novartis’ systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior Novartis may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those ) and/or review(s) conducted as part of the Field Force Monitoring Program of Promotional Activities described in Section III.L or the Monitoring monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by both internal and outside entities at Indivior’s Novartis’ request be substituted, subject to the Verification Review requirements set forth below, 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 Indivior’s Novartis’ internal audit work or monitoring and/or other reviews conducted by outside entities to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Indivior’s Novartis’ planned internal monitoring activities and audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s Novartis’ demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s Novartis’ request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Novartis shall engage the IRO to perform the Review as outlined in this Section III.E. 4. If the OIG agrees to permit certain of Novartis’ monitoring, internal audit work. or other reviews for a given Reporting Period to be substituted for a portion of Additional Items review, such work would 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.

IRO Review of Additional Items. ‌ As set forth referenced in Section III.E.2.c III.E.2 of the CIA, for each the second through fifth Reporting Period, the 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. No 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, the OIG shall notify Indivior 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 and/or Indivior shall submit an audit work plan to the OIG for approval and the approval. 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 IndiviorAmgen’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request be substituted, subject to the Verification Review requirements set forth below, 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 Indivior’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Indivior’s planned internal audit work or compliance monitoring or audit activities, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior shall engage the IRO to perform the Review as outlined in this Section III.E.Item).‌

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E 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”).Items”).‌‌‌ 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Avanir 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 Indivior Avanir 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. 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 IndiviorAvanir’s systems, processes, policies, and procedures based on its review of each Additional Item).Item).‌ 2. Indivior Avanir may propose to the OIG that its internal compliance audit(s), reviews, or monitoring activities, including those ) and/or reviews conducted as part of the Field Force Monitoring Program described in Section III.L Section‌‌ III.K or the Monitoring of Non-Promotional Activities described in Section III.M III.L of the CIA and/or other reviews conducted by outside entities at IndiviorAvanir’s request be substituted, subject to the Verification Review requirements set forth below, 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 IndiviorXxxxxx’s internal compliance audit work or monitoring activities to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorXxxxxx’s planned internal compliance audit work or compliance and monitoring or audit activities, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s Xxxxxx demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorAvanir’s request to permit its internal compliance audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Avanir shall engage the IRO to perform the Review as outlined in this Section III.E.III.D.‌ 4. If the OIG agrees to permit certain of Xxxxxx’s compliance audit work or monitoring activities for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would 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.‌

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E 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”).Items”).‌‌ 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior USWM 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 Indivior USWM 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. 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 IndiviorUSWM’s systems, processes, policies, and procedures based on its review of each Additional Item).Item).‌ 2. Indivior USWM may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request ) be substituted, subject to the Verification Review requirements set forth below, 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 IndiviorUSWM’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO.IRO.‌ 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorUSWM’s planned internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and IndiviorUSWM’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorUSWM’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior USWM shall engage the IRO to perform the Review as outlined in this Section III.E.III.F.‌ 4. If the OIG agrees to permit certain of USWM’s internal audit work for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would 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.‌

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E.2 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”). 1. 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 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior 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 Indivior United Therapeutics shall submit an audit work plan to the OIG for approval and the approval. 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 Indivior’s United Therapeutics’ systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior United Therapeutics may propose to the OIG that its relevant internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA ) and/or other reviews conducted by outside entities at Indivior’s United Therapeutics’ request be substituted, subject to the Verification Review requirements set forth below, substituted for one or more of the Additional Items Item reviews that would otherwise be reviewed conducted by the IRO for the applicable Reporting Period. The OIG retains sole discretion over whether, and in what manner, to allow Indivior’s United Therapeutics’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Indivior’s United Therapeutics’ planned monitoring activities and internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s United Therapeutics’ demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s United Therapeutics’ request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior United Therapeutics shall engage the IRO to perform the Review as outlined in this Section III.E.IV. If OIG agrees to permit certain of United Therapeutics’ 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.

IRO Review of Additional Items. ‌ As set forth in Section III.E.2.c III.E.2 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”). 1. The Additional Items may include activities undertaken by Astellas 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 Astellas in connection with any Pharmaceutical Manufacturer PAP, including the provision of free product to patients. No later than 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior 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 Indivior Astellas shall submit an audit work plan to the OIG for approval and the approval. 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 Indivior’s Astellas’ systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior Astellas may propose to the OIG that its relevant internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA ) and/or other reviews conducted by outside entities at Indivior’s Astellas’ request be substituted, subject to the Verification Review requirements set forth below, substituted for one or more of the Additional Items Item reviews that would otherwise be reviewed conducted by the IRO for the applicable Reporting Period. The OIG retains sole discretion over whether, and in what manner, to allow Indivior’s Astellas’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG XXX agrees to consider, among other factors, the nature and scope of Indivior’s Astellas’ planned monitoring activities and internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s Astellas’ demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s Astellas’ request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Astellas shall engage the IRO to perform the Review as outlined in this Section III.E.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.

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”). 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Mallinckrodt 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 Indivior Mallinckrodt shall submit an audit work plan to the OIG for approval and its review. If the OIG does not object to the audit work plan, then the IRO shall conduct the review of the Additional Items based on a the 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 IndiviorMallinckrodt’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior Mallinckrodt may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request ) be substituted, subject to the Verification Review requirements set forth below, 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 IndiviorMallinckrodt’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorMallinckrodt’s planned internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and IndiviorMallinckrodt’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorMallinckrodt’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Mallinckrodt shall engage the IRO to perform the Review as outlined in this Section III.E. 4. If the OIG agrees to permit certain of Mallinckrodt’s internal audit work for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would 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.

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E.2 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”). 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Sandoz 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 Indivior Sandoz shall submit an audit work plan to the OIG for approval and review and, absent any objection from the OIG, the IRO shall conduct the review of the Additional Items based on a the work plan approved by the OIGplan. 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 IndiviorSandoz’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior Sandoz may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those ) and/or review(s) conducted as part of the Field Force Internal Monitoring Program (IMP) described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M III.K of the CIA and/or other reviews conducted by both internal and outside entities at Indivior’s Xxxxxx’x request be substituted, subject to the Verification Review requirements set forth below, 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 Indivior’s Xxxxxx’x internal audit work or monitoring and/or other reviews conducted by outside entities to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Indivior’s Xxxxxx’x planned internal monitoring activities and audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s Xxxxxx’x demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s Xxxxxx’x request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Xxxxxx shall engage the IRO to perform the Review as outlined in this Section III.E.III.B. 4. If the OIG agrees to permit certain of Xxxxxx’x monitoring, internal audit work, or other reviews for a given Reporting Period to be substituted for a portion of Additional Items review, such work would 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.

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E 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”).Items”).‌ 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Insys 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 Indivior Insys 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. 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 IndiviorInsys’s systems, processes, policies, and procedures based on its review of each Additional Item).Item).‌ 2. Indivior Insys may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those ) and/or reviews conducted as part of the Field Force Monitoring Program described in Section Section‌‌ III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request be substituted, subject to the Verification Review requirements set forth below, 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 IndiviorInsys’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorInsys’s planned monitoring activities and internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s Insys demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorInsys’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Insys shall engage the IRO to perform the Review as outlined in this Section III.E.III.F.‌ 4. If the OIG agrees to permit certain of Insys’s internal audit work for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would 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.‌

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E.2 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”). 1. The Additional Items may include activities undertaken by Jazz 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 Jazz in connection with any Pharmaceutical Manufacturer PAP, including the provision of free product to patients. No later than 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior Jazz 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 Indivior Jazz shall submit an audit work plan to the OIG for approval and the approval. 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 IndiviorJazz’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior Jazz may propose to the OIG that its relevant internal audit(s), reviews, ) or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at IndiviorJazz’s request be substituted, subject to the Verification Review requirements set forth below, substituted for one or more of the Additional Items Item reviews that would otherwise be reviewed conducted by the IRO for the applicable Reporting Period. The OIG retains sole discretion over whether, and in what manner, to allow IndiviorJazz’s internal audit work or monitoring and/or other reviews conducted by outside entities to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorJazz’s planned monitoring activities and internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and IndiviorJazz’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorJazz’s request to permit its internal audit work or compliance monitoring or audit activities and/or other reviews conducted by outside entities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior Jazz shall engage the IRO to perform the Review as outlined in this Section III.E.IV. Jazz Pharmaceuticals plc CIA Appendix B If OIG agrees to permit certain of Jazz’s internal audit work or other reviews for a given Reporting Period to be substituted for a portion of an Additional Items review, such internal work or reviews 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.

IRO Review of Additional Items. ‌ As set forth in Section III.E.2.c III.E.2 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”). 1. The Additional Items may include activities undertaken by Sanofi 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 Sanofi in connection with any Sanofi PAP, including the provision of free product to patients. No later than 120 150 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior 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 Indivior Sanofi shall submit an audit work plan to the OIG for approval and the approval. 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 IndiviorSanofi’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior Sanofi may propose to the OIG that its relevant internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA ) and/or other reviews conducted by outside entities at IndiviorSanofi’s request be substituted, subject to the Verification Review requirements set forth below, substituted for one or more of the Additional Items Item reviews that would otherwise be reviewed conducted by the IRO for the applicable Reporting Period. The OIG retains sole discretion over whether, and in what manner, to allow IndiviorSanofi’s internal monitoring or audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of Indivior’s planned internal audit work or compliance monitoring or audit activities, the results of the Transactions Review(s) during prior Reporting Period(s), and Indivior’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies Indivior’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior shall engage the IRO to perform the Review as outlined in this Section III.E.

IRO Review of Additional Items. As set forth in Section III.E.2.c III.E 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”). 1. No later than 120 days prior to the end of the applicable Reporting Period, the OIG shall notify Indivior SUN 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 Indivior SUN 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. 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 IndiviorSUN’s systems, processes, policies, and procedures based on its review of each Additional Item). 2. Indivior SUN may propose to the OIG that its internal audit(s), reviews, or monitoring activities, including those conducted as part of the Field Force Monitoring Program described in Section III.L or the Monitoring of Non-Promotional Activities described in Section III.M of the CIA and/or other reviews conducted by outside entities at Indivior’s request ) be substituted, subject to the Verification Review requirements set forth below, 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 IndiviorXXX’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. 3. In making its decision, the OIG agrees to consider, among other factors, the nature and scope of IndiviorSUN’s planned internal audit work or compliance monitoring or audit activitieswork, the results of the Transactions Review(s) during prior Reporting Period(s), and IndiviorSUN’s demonstrated audit capabilities to perform the proposed audit work internally. If the OIG denies IndiviorSUN’s request to permit its internal audit work or compliance monitoring or audit activities to be substituted for a portion of the IRO’s review of Additional Items in a given Reporting Period, Indivior SUN shall engage the IRO to perform the Review as outlined in this Section III.E.III.D. 4. If the OIG agrees to permit certain of XXX’s internal audit work for a given Reporting Period to be substituted for a portion of Additional Items review, such internal work would 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.