Common use of Frequency and Brief Description of Reviews Clause in Contracts

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and C, the IRO Reviews shall consist of three components: (1) Systems Reviews and Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviews. The Systems Reviews shall assess the J&J Pharmaceutical Affiliates systems, processes, policies, and procedures relating to the Covered Functions and the RAMP Program. If there are no material changes in relevant systems, processes, policies, and procedures, the Systems Review shall be performed for the periods covering the second and fifth Reporting Periods. If a J&J Pharmaceutical Affiliate materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform Systems Reviews for the Reporting Period in which such changes were made in addition to conducting a Systems Review for the second and fifth Reporting Periods, as set forth more fully in Appendices B and C. The Transactions Reviews shall be performed annually and shall cover each of the six Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and C, the Transactions Reviews shall include several components. In addition, as set forth in Appendix B, the Transactions Reviews relating to Covered Functions shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates 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 the J&J Pharmaceutical Affiliates and may consider internal audit work conducted by the J&J Pharmaceutical Affiliates, the Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical Affiliates, the nature and scope of the J&J Pharmaceutical Affiliates’ promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates 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 the J&J Pharmaceutical Affiliates’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates 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 applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates 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.

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews shall consist of three components: (1) two components - a Systems Reviews Review and a Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsReview. The Systems Reviews Review shall assess the J&J Pharmaceutical Affiliates Novartis’ systems, processes, policies, and procedures relating to the Covered Promotional Functions and the RAMP ProgramProduct Related Functions. If there are no material changes in Novartis’ relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Novartis materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Reviews Review for the Reporting Period in which such Novartis Pharmaceuticals Corporation Corporate Integrity Agreement changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B and C. Appendix B. The Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and CAppendix B, the Transactions Reviews Review shall include several components. In addition, as set forth in Appendix B, the each Transactions Reviews relating to Covered Functions Review shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates Novartis 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 the J&J Pharmaceutical Affiliates Novartis and may consider internal audit work conducted by the J&J Pharmaceutical AffiliatesNovartis, the Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical Affiliatesportfolio, the nature and scope of the J&J Pharmaceutical AffiliatesNovartis’ promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates Novartis 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 the J&J Pharmaceutical AffiliatesNovartis’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Novartis 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 applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates 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.. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews Promotional and Product Related Review shall consist of three components: (1) two components - a Systems Reviews Review and a Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsReview. The Systems Reviews Review shall assess the J&J Pharmaceutical Affiliates Forest’s systems, processes, policies, and procedures relating to the Covered Promotional and Product Related Functions and the RAMP ProgramRegulatory Related Functions. If there are no material changes in relevant Forest’s systems, processes, policies, and proceduresprocedures relating to these Functions, the Promotional and Product Related Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Forest materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Reviews Review for the Reporting Period in which such changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B and C. . The Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Transactions Review. As set forth more fully in Appendices B and C, the Transactions Reviews shall include several components. In addition, as set forth in Appendix B, the Transactions Reviews Review shall include several components, including a review relating to Covered Functions inquiries included in Forest’s MIC Inquiries Database, a review of Forest’s Call Panel Assessments, a review of “Sampling Events” (as defined in Appendix B) and a review of records relating to a sample of the Payments that are reported by Forest pursuant to Section III.M below. Corporate Integrity Agreement Forest Laboratories, Inc. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates Forest 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 the J&J Pharmaceutical Affiliates Forest and may consider internal audit work conducted by the J&J Pharmaceutical AffiliatesForest, the Forest’s Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical Affiliatesportfolio, the nature and scope of the J&J Pharmaceutical Affiliates’ Forest’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates Forest 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 the J&J Pharmaceutical Affiliates’ Xxxxxx’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Forest of the nature and scope of the IRO review Review for each of the Additional Items not later than 120 150 days prior to the end of each applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates Forest 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.

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews Promotional and Product Services Review shall consist of three components: (1) two components — a Systems Reviews Review and a Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsReview. The Systems Reviews Review shall assess the J&J Pharmaceutical Affiliates Lilly’s systems, processes, policies, and procedures relating to the Covered Functions Promotional and the RAMP ProgramProduct Services Related Functions. If there are no material changes in relevant Lilly’s systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the Promotional and Product Services Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Lilly materially changes its relevant systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the IRO shall perform a Systems Reviews Review for the Corporate Integrity Agreement Xxx Xxxxx Company Reporting Period in which such changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B . The Promotional and C. The Product Services Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and C, the Transactions Reviews shall include several components. In addition, as set forth in Appendix B, the Transactions Reviews Review shall include several components, including a review relating to Covered Functions inquiries included in Lilly’s TLAC Database, a review of Lilly’s Call Plan Assessments, a review of Sampling Events, and a review of records relating to a sample of the Payments that are reported by Lilly pursuant to Section III.M below. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates Lilly 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 the J&J Pharmaceutical Affiliates Lilly and may consider internal audit work conducted by Lilly and/or the J&J Pharmaceutical AffiliatesLilly Compliance Monitoring Program, the Lilly’s Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical Affiliatesportfolio, the nature and scope of the J&J Pharmaceutical Affiliates’ Lilly’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Section III.E of Appendix B, the J&J Pharmaceutical Affiliates Lilly 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 the J&J Pharmaceutical Affiliates’ Lilly’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Lilly 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 applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates Lilly shall submit an audit work Corporate Integrity Agreement Xxx Xxxxx Company 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.

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews Promotional and Product Related Review shall consist of three components: (1) two components - a Systems Reviews Review and a Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsReview. The Systems Reviews Review shall assess the J&J Pharmaceutical Affiliates Forest’s systems, processes, policies, and procedures relating to the Covered Promotional and Product Related Functions and the RAMP ProgramRegulatory Related Functions. If there are no material changes in relevant Forest’s systems, processes, policies, and proceduresprocedures relating to these Functions, the Promotional and Product Related Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Forest materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Reviews Review for the Reporting Period in which such changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B and C. . The Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Transactions Review. As set forth more fully in Appendices B and C, the Transactions Reviews shall include several components. In addition, as set forth in Appendix B, the Transactions Reviews Review shall include several components, including a review relating to Covered Functions inquiries included in Forest’s MIC Inquiries Database, a review of Forest’s Call Panel Assessments, a review of “Sampling Events” (as defined in Appendix B) and a review of records relating to a sample of the Payments that are reported by Forest pursuant to Section III.M below. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates Forest 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 the J&J Pharmaceutical Affiliates Forest and may consider internal audit work conducted by the J&J Pharmaceutical AffiliatesForest, the Forest’s Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical Affiliatesportfolio, the nature and scope of the J&J Pharmaceutical Affiliates’ Forest’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates Forest 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 the J&J Pharmaceutical Affiliates’ Forest’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Forest of the nature and scope of the IRO review Review for each of the Additional Items not later than 120 150 days prior to the end of each applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates Forest 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.

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews Promotional and Product Services Review shall consist of three components: (1) two components - a Systems Reviews Review and a Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsReview. The Systems Reviews Review shall assess the J&J Pharmaceutical Affiliates Cephalon’s systems, processes, policies, and procedures relating to the Covered Functions Promotional and the RAMP ProgramProduct Services Related Functions. If there are no material changes in relevant Cephalon’s systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the Promotional and Product Services Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Cephalon materially changes its relevant systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the IRO shall perform a Systems Reviews Review for the Reporting Period in which such changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B . The Promotional and C. The Product Services Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and C, the Transactions Reviews shall include several components. In addition, as set forth in Appendix B, the Transactions Reviews Review shall include several components, including a review relating to Covered Functions Inquiries included in Cephalon’s Inquiries Database, a review of Cephalon’s Call Plan Assessments, and a review of a records relating to a sample of the Payments that are reported by Cephalon pursuant to Section III.M below. In addition, beginning with the second Reporting Period, each Transactions Review shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates Cephalon 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 the J&J Pharmaceutical Affiliates Cephalon and may consider internal audit work conducted or planned by the J&J Pharmaceutical AffiliatesCephalon, the Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical AffiliatesCephalon’s product portfolio, the nature and scope of the J&J Pharmaceutical Affiliates’ Cephalon’s promotional practices and arrangements with HCPs and HCIsHCPs, and other information known to it. As set forth more fully in Section III.D of Appendix B, the J&J Pharmaceutical Affiliates Cephalon 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 the J&J Pharmaceutical AffiliatesCephalon’ s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Cephalon of the nature and scope of the IRO review for each of the Additional Items not no later than 120 90 days prior to the end of each applicable the second through fifth Reporting PeriodPeriods. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates Cephalon 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.

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews Review shall consist of three components: (1) two components — a Systems Reviews Review and a Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsReview. The Systems Reviews Review shall assess the J&J Pharmaceutical Affiliates Elan’s systems, processes, policies, and procedures relating to the Covered certain aspects of Government Pricing and Contracting Functions and the RAMP ProgramMedical Affairs and Materials Related Functions (Systems Review). If As set forth in Appendix B, if there are no material changes in Elan’s relevant systems, processes, policies, and procedures, the Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Elan materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Reviews Review for the Reporting Period in which such changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B and C. . The Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and C, the Transactions Reviews shall include several components. In addition, as set forth in Appendix B, the each Transactions Reviews relating to Covered Functions Review shall also include a review of up to three two additional areas or practices of the J&J Pharmaceutical Affiliates Elan, subject to modification if Elan undertakes additional Promotion Related Functions, related to a Government Reimbursed Products 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 the J&J Pharmaceutical Affiliates Elan and may consider internal audit work conducted by the J&J Pharmaceutical AffiliatesElan, the Elan’s Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical AffiliatesProducts portfolio, the nature and scope of the J&J Pharmaceutical Affiliates’ promotional practices Elan’s activities and arrangements with HCPs and HCIsHCIs related to Government Reimbursed Products, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates 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 the J&J Pharmaceutical Affiliates’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Elan of the nature and scope of the IRO review Review for each of the Additional Items not later than 120 days prior to the end of each applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates Elan 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.

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and C, the IRO Reviews shall consist of three components: (1) Systems Reviews and Transactions Reviews relating to the Covered Functions; (2) Additional Items reviews; and (3) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsERM program. The Systems Reviews shall assess the J&J Pharmaceutical Affiliates Par’s systems, processes, policies, and procedures relating to the Covered Functions and the RAMP ProgramERM program. If there are no material changes in Par’s relevant systems, processes, policies, and procedures, the Systems Review shall be performed for the Par Corporate Integrity Agreement periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Par materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform Systems Reviews for the Reporting Period in which such changes were made in addition to conducting a Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B and C. The Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and C, the Transactions Reviews Review shall include several components. In addition, as set forth in Appendix B, the Transactions Reviews relating to Covered Functions Review shall also include a review of up to three four additional areas or practices of the J&J Pharmaceutical Affiliates Par 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 IRO Reporting Period, the OIG will consult with the J&J Pharmaceutical Affiliates Par and may consider internal audit work conducted by the J&J Pharmaceutical AffiliatesPar, the Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical AffiliatesPar, the nature and scope of the J&J Pharmaceutical Affiliates’ Par’s promotional practices and arrangements with HCPs and HCIs, any additional types of non- promotional activities engaged in by Par, including but not limited to advisory boards, post-marketing research, physician publications, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates Par 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 the J&J Pharmaceutical Affiliates’ Xxx’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Par 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 applicable IRO Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates Par Corporate Integrity Agreement Par 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.

Frequency and Brief Description of Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews shall consist of three two components: (1) a Systems Reviews Review and a Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviewsReview. The Systems Reviews Review shall assess the J&J Pharmaceutical Affiliates Allergan’s systems, processes, policies, and procedures relating to the Covered Promotional Functions and the RAMP ProgramProduct Related Functions. If there are no material changes in Allergan’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate Allergan materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Reviews Review for the Reporting Period in which such changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B Appendix B. The Promotional and C. The Product Services Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and CAppendix B, the Transactions Reviews Review shall include several components. In addition, as set forth in Appendix B, the each Transactions Reviews relating to Covered Functions Review shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates Allergan 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 the J&J Pharmaceutical Affiliates Allergan and may consider internal audit work conducted by the J&J Pharmaceutical AffiliatesAllergan, the Allergan’s Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical Affiliatesportfolio, the nature and scope of the J&J Pharmaceutical Affiliates’ Allergan’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates Allergan 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 the J&J Pharmaceutical Affiliates’ Allergan’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates Allergan 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 applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates Allergan 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.

Frequency and Brief Description of Reviews. (i) System, Transaction, and Additional Items Reviews. As set forth more fully in Appendices B and CAppendix B, the IRO Reviews reviews shall consist of three two components: (1) Systems Reviews and Transactions Reviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviews. The Systems Reviews shall assess the J&J Pharmaceutical Affiliates BIPI’s systems, processes, policies, and procedures relating to the Covered Functions and the RAMP ProgramFunctions. If there are no material changes in BIPI’s relevant systems, processes, policies, and procedures, the Systems Review shall be performed for the periods covering the second first and fifth fourth Reporting Periods. If a J&J Pharmaceutical Affiliate BIPI materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Reviews Review for the Reporting Period in which such changes were made in addition to conducting a the Systems Review for the second first and fifth fourth Reporting Periods, as set forth more fully in Appendices B and C. Appendix B. The Transactions Reviews Review shall be performed annually and shall cover each of the six five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendices B and CAppendix B, the Transactions Reviews Review shall include several components. In addition, as set forth in Appendix B, the each Transactions Reviews relating to Covered Functions Review shall also include a review of up to three additional areas or practices of the J&J Pharmaceutical Affiliates BIPI 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 the J&J Pharmaceutical Affiliates BIPI and may consider internal audit work conducted by the J&J Pharmaceutical AffiliatesBIPI, the Government Reimbursed Product portfolio of J&J and the J&J Pharmaceutical Affiliatesportfolio, the nature and scope of the J&J Pharmaceutical Affiliates’ BIPI’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, the J&J Pharmaceutical Affiliates BIPI may propose to the OIG that its internal audit(s) and/or review(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 the J&J Pharmaceutical Affiliates’ XXXX’s monitoring activities and internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify J&J and/or the J&J Pharmaceutical Affiliates BIPI 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 applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or J&J and/or the J&J Pharmaceutical Affiliates BIPI 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.