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

Frequency and Brief Description of Reviews. As set forth more fully in Appendix B, the IRO Reviews shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AstraZeneca’s systems, processes, policies, and procedures relating to Promotional Functions and Product Related Functions. If there are no material changes in AstraZeneca’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of AstraZeneca 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 AstraZeneca and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZeneca, the Government Reimbursed Product portfolio, the nature and scope of AstraZeneca’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca 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 AstraZeneca’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca of the nature and scope of the IRO review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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 Appendix BAppendices B and C, the IRO Reviews shall consist of two components - a three components: (1) Systems Review Reviews and a Transactions ReviewReviews relating to the Covered Functions; (2) Systems Reviews and Transaction Reviews relating to the RAMP Program; and (3) Additional Items reviews. The Systems Review Reviews shall assess AstraZeneca’s the J&J Pharmaceutical Affiliates systems, processes, policies, and procedures relating to Promotional the Covered Functions and Product Related Functionsthe RAMP Program. If there are no material changes in AstraZeneca’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the first second and fourth fifth Reporting Periods. If AstraZeneca a J&J Pharmaceutical Affiliate materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review Reviews for the Reporting Period in which such changes were made in addition to conducting the a Systems Review for the first second and fourth fifth Reporting Periods, as set forth more fully in Appendix B. Appendices B and C. The Transactions Review Reviews shall be performed annually and shall cover each of the five six Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix BAppendices B and C, the Transactions Review Reviews shall include several components. In addition, each as set forth in Appendix B, the Transactions Review Reviews relating to Covered Functions shall also include a review of up to three additional areas or practices of AstraZeneca 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 AstraZeneca the J&J Pharmaceutical Affiliates and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecathe J&J Pharmaceutical Affiliates, the Government Reimbursed Product portfolioportfolio of J&J and the J&J Pharmaceutical Affiliates, the nature and scope of AstraZeneca’s 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, AstraZeneca 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 AstraZeneca’s 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 AstraZeneca 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 150 120 days prior to the end of each applicable Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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 Appendix B, the IRO Reviews Review shall consist of two components - — a Systems Review and a Transactions Review. The Systems Review shall assess AstraZenecaElan’s systems, processes, policies, and procedures relating to Promotional the certain aspects of Government Pricing and Contracting Functions and Product Medical Affairs and Materials Related FunctionsFunctions (Systems Review). If As set forth in Appendix B, if there are no material changes in AstraZenecaElan’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Elan materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. . The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components. In addition, each Transactions Review shall also include a review of up to three two additional areas or practices of AstraZeneca 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 AstraZeneca Elan and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaElan, the Elan’s Government Reimbursed Product Products portfolio, the nature and scope of AstraZenecaElan’s promotional practices 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, AstraZeneca 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 AstraZeneca’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Elan of the nature and scope of the IRO review Review for each of the Additional Items not later than 150 120 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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 Appendix BAppendices B and C, the IRO Reviews shall consist of two components - a three components: (1) Systems Review Reviews and a Transactions ReviewReviews relating to the Covered Functions; (2) Additional Items reviews; and (3) Systems Reviews and Transaction Reviews relating to the ERM program. The Systems Review Reviews shall assess AstraZenecaPar’s systems, processes, policies, and procedures relating to Promotional the Covered Functions and Product Related Functionsthe ERM program. If there are no material changes in AstraZenecaPar’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the Par Corporate Integrity Agreement periods covering the first and fourth Reporting Periods. If AstraZeneca Par materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review Reviews for the Reporting Period in which such changes were made in addition to conducting the a Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. Appendices B and C. The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix BAppendices B and C, the Transactions Review shall include several components. In addition, each the Transactions Review shall also include a review of up to three four additional areas or practices of AstraZeneca 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 AstraZeneca Par and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaPar, the Government Reimbursed Product portfolioportfolio of Par, the nature and scope of AstraZenecaPar’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, AstraZeneca 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 AstraZenecaPar’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Par of the nature and scope of the IRO review for each of the Additional Items not later than 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 AstraZeneca 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 Appendix B, the IRO Reviews shall consist of two components - components: a Systems Review and a Transactions Review. The Systems Review shall assess AstraZenecaAllergan’s systems, processes, policies, and procedures relating to Promotional Functions and Product Related Functions. If there are no material changes in AstraZenecaAllergan’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Allergan materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. The Promotional and Product Services Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of AstraZeneca 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 AstraZeneca Allergan and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaAllergan, the Allergan’s Government Reimbursed Product portfolio, the nature and scope of AstraZenecaAllergan’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca 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 AstraZenecaAllergan’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Allergan of the nature and scope of the IRO review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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. As set forth more fully in Appendix B, the IRO Reviews Promotional and Product Related Review shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AstraZenecaForest’s systems, processes, policies, and procedures relating to Promotional and Product Related Functions and Product Regulatory Related Functions. If there are no material changes in AstraZenecaForest’s relevant systems, processes, policies, and proceduresprocedures relating to these Functions, the IRO Promotional and Product Related Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Forest materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. . The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Transactions Review. As set forth more fully in Appendix B, the Transactions Review shall include several components, including a review relating to 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 AstraZeneca 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 AstraZeneca Forest and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaForest, the Forest’s Government Reimbursed Product portfolio, the nature and scope of AstraZenecaForest’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca 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 AstraZenecaForest’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Forest of the nature and scope of the IRO review Review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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 Appendix B, the IRO Reviews shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AstraZeneca’s Novartis’ systems, processes, policies, and procedures relating to Promotional Functions and Product Related Functions. If there are no material changes in AstraZeneca’s Novartis’ relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Novartis materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such Novartis Pharmaceuticals Corporation Corporate Integrity Agreement changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of AstraZeneca 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 AstraZeneca Novartis and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaNovartis, the Government Reimbursed Product portfolio, the nature and scope of AstraZeneca’s Novartis’ promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca 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 AstraZeneca’s Novartis’ internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Novartis of the nature and scope of the IRO review for each of the Additional Items not later than 150 120 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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. System, Transaction, and Additional Items Reviews. As set forth more fully in Appendix BAppendices B and C, the IRO Reviews shall consist of two components - a components: Systems Review Reviews and a Transactions ReviewReviews relating to the Covered Functions and to the Ra3 process. The Systems Review Reviews shall assess AstraZenecaAmgen’s systems, processes, policies, and procedures relating to Promotional the Covered Functions and Product Related Functionsto the Ra3 process. If there are no material changes in AstraZenecaAmgen’s relevant systems, processes, policies, and procedures, the IRO Systems Review Reviews shall be performed for the periods covering the first second and fourth Reporting Periods. If AstraZeneca Amgen materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first second and fourth Reporting Periods, as set forth more fully in Appendix B. Appendices B and C. The Transactions Review Reviews shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix BAppendices B and C, the Transactions Review shall include several components. In addition, as set forth in Appendix B, each Transactions Review relating to Covered Functions shall also include a review of up to Corporate Integrity Agreement Amgen Inc. three additional areas or practices of AstraZeneca Amgen 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 AstraZeneca Amgen and may consider internal audit and monitoring work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaAmgen, the Government Reimbursed Product portfolio, the nature and scope of AstraZenecaAmgen’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca Amgen may propose to the OIG that its internal audit(sHealthcare Compliance Internal Audit(s) and Healthcare Compliance Monitoring activities be partially substituted substituted, in whole or in part as may be appropriate under the circumstances, 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 AstraZenecaXxxxx’s internal audit and monitoring work to be substituted for a any portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Amgen of the nature and scope of the IRO review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca Amgen 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 Appendix B, the IRO Reviews Promotional and Product Related Review shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AstraZenecaForest’s systems, processes, policies, and procedures relating to Promotional and Product Related Functions and Product Regulatory Related Functions. If there are no material changes in AstraZenecaForest’s relevant systems, processes, policies, and proceduresprocedures relating to these Functions, the IRO Promotional and Product Related Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Forest materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. . The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Transactions Review. As set forth more fully in Appendix B, the Transactions Review shall include several components, including a review relating to 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 AstraZeneca 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 AstraZeneca Forest and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaForest, the Forest’s Government Reimbursed Product portfolio, the nature and scope of AstraZenecaForest’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca 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 AstraZenecaXxxxxx’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Forest of the nature and scope of the IRO review Review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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 Appendix B, the IRO Reviews Promotional and Product Services Review shall consist of two components - — a Systems Review and a Transactions Review. The Systems Review shall assess AstraZenecaLilly’s systems, processes, policies, and procedures relating to Promotional Functions and Product Services Related Functions. If there are no material changes in AstraZenecaLilly’s relevant systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the IRO Promotional and Product Services Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Lilly materially changes its relevant systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the IRO shall perform a Systems Review for the Corporate Integrity Agreement Xxx Xxxxx Company Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. . The Promotional and Product Services Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components, including a review relating to 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 AstraZeneca 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 AstraZeneca Lilly and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaLilly and/or the Lilly Compliance Monitoring Program, the Lilly’s Government Reimbursed Product portfolio, the nature and scope of AstraZenecaLilly’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, AstraZeneca 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 AstraZenecaLilly’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Lilly of the nature and scope of the IRO review for each of the Additional Items not later than 150 120 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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 Appendix BAppendices B and C, the IRO Reviews shall consist of two components - a three components: (1) Systems Review Reviews and a Transactions ReviewReviews relating to the Covered Functions; (2) Additional Items reviews; and (3) Systems Reviews and Transaction Reviews relating to the ERM program. The Systems Review Reviews shall assess AstraZenecaPar’s systems, processes, policies, and procedures relating to Promotional the Covered Functions and Product Related Functionsthe ERM program. If there are no material changes in AstraZenecaPar’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the Par Corporate Integrity Agreement periods covering the first and fourth Reporting Periods. If AstraZeneca Par materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review Reviews for the Reporting Period in which such changes were made in addition to conducting the a Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. Appendices B and C. The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix BAppendices B and C, the Transactions Review shall include several components. In addition, each the Transactions Review shall also include a review of up to three four additional areas or practices of AstraZeneca 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 AstraZeneca Par and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaPar, the Government Reimbursed Product portfolioportfolio of Par, the nature and scope of AstraZenecaPar’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, AstraZeneca 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 AstraZenecaXxx’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Par of the nature and scope of the IRO review for each of the Additional Items not later than 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 AstraZeneca 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 Appendix B, the IRO Reviews Promotional and Product Related Review shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AstraZenecaForest’s systems, processes, policies, and procedures relating to Promotional and Product Related Functions and Product Regulatory Related Functions. If there are no material changes in AstraZenecaForest’s relevant systems, processes, policies, and proceduresprocedures relating to these Functions, the IRO Promotional and Product Related Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Forest materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. . The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Transactions Review. As set forth more fully in Appendix B, the Transactions Review shall include several components, including a review relating to 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 AstraZeneca 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 AstraZeneca Forest and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaForest, the Forest’s Government Reimbursed Product portfolio, the nature and scope of AstraZenecaForest’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca 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 AstraZenecaForest’s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Forest of the nature and scope of the IRO review Review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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 Appendix B, the IRO Reviews Promotional and Product Services Review shall consist of two components - a Systems Review and a Transactions Review. The Systems Review shall assess AstraZenecaCephalon’s systems, processes, policies, and procedures relating to Promotional Functions and Product Services Related Functions. If there are no material changes in AstraZenecaCephalon’s relevant systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the IRO Promotional and Product Services Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca Cephalon materially changes its relevant systems, processes, policies, and proceduresprocedures relating to Promotional and Product Services Related Functions, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. . The Promotional and Product Services Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components, including a review relating to 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 AstraZeneca 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 AstraZeneca Cephalon and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted or planned by AstraZenecaCephalon, the Government Reimbursed Product Cephalon’s product portfolio, the nature and scope of AstraZenecaCephalon’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, AstraZeneca 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 AstraZeneca’s Cephalon’ s internal audit work to be substituted for a portion of the Additional Items review conducted by the IRO. The OIG shall notify AstraZeneca Cephalon of the nature and scope of the IRO review for each of the Additional Items not no later than 150 90 days prior to the end of each the second through fifth Reporting PeriodPeriods. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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. (i) System, Transaction, and Additional Items Reviews. As set forth more fully in Appendix B, the IRO Reviews reviews shall consist of two components - a components: Systems Review Reviews and a Transactions ReviewReviews relating to the Covered Functions. The Systems Review Reviews shall assess AstraZenecaBIPI’s systems, processes, policies, and procedures relating to Promotional Functions and Product Related the Covered Functions. If there are no material changes in AstraZenecaBIPI’s relevant systems, processes, policies, and procedures, the IRO Systems Review shall be performed for the periods covering the first and fourth Reporting Periods. If AstraZeneca BIPI materially changes its relevant systems, processes, policies, and procedures, the IRO shall perform a Systems Review for the Reporting Period in which such changes were made in addition to conducting the Systems Review for the first and fourth Reporting Periods, as set forth more fully in Appendix B. The Transactions Review shall be performed annually and shall cover each of the five Reporting Periods. The IRO(s) shall perform all components of each annual Transaction Review. As set forth more fully in Appendix B, the Transactions Review shall include several components. In addition, each Transactions Review shall also include a review of up to three additional areas or practices of AstraZeneca 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 AstraZeneca BIPI and may consider internal audit work Corporate Integrity Agreement AstraZeneca conducted by AstraZenecaBIPI, the Government Reimbursed Product portfolio, the nature and scope of AstraZenecaBIPI’s promotional practices and arrangements with HCPs and HCIs, and other information known to it. As set forth more fully in Appendix B, AstraZeneca 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 AstraZenecaXXXX’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 AstraZeneca BIPI of the nature and scope of the IRO review for each of the Additional Items not later than 150 days prior to the end of each Reporting Period. Prior to undertaking the review of the Additional Items, the IRO and/or AstraZeneca 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.