Common use of Consultant Arrangement Activities Clause in Contracts

Consultant Arrangement Activities. To the extent that GSK engages U.S.-based HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- market value analysis conducted by GSK. To the extent not already accomplished, within 120 days after the Effective Date, GSK shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSK’s Monitoring Personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring Personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK received the work product generated by the Consultant.

Consultant Arrangement Activities. To the extent that GSK AstraZeneca engages U.S.-based HCPs or HCIs for services other than for speaker programs, tutorials, preceptorships, or research-related functions that relate to Promotional Functions or to Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK AstraZeneca shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKAstraZeneca. To the extent not already accomplished, within 120 days after the Effective Date, GSK AstraZeneca shall establish a process to develop annual quarterly budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following yearquarter. The annual quarterly Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKAstraZeneca’s Monitoring Personnel U.S. compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK AstraZeneca Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement AstraZeneca To the extent not already accomplished, within 120 days after the Effective Date, GSK AstraZeneca shall establish a process to ensure that a needs assessment (or business rationale form) has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelAstraZeneca U.S. compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK AstraZeneca shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK AstraZeneca received the work product generated by the Consultant. Within 120 days after the Effective Date, AstraZeneca shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 70 Consultant arrangements with HCPs. The Consultant Program Audits shall include at least 20 advisory board programs and 50 professional services agreements with HCPs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. AstraZeneca U.S. compliance personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with AstraZeneca’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the U.S. Compliance Department for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK BIPI engages U.S.-based U.S.- based HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK BIPI shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKBIPI. To the extent not already accomplished, within 120 days after the Effective Date, GSK BIPI shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKBIPI’s Monitoring Personnel compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK BIPI Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK BIPI shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelBIPI compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK BIPI shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK XXXX received the work product generated by the Consultant. Within 120 days after the Effective Date, BIPI shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 40 Consultant arrangements with HCPs. More specifically, Monitoring Personnel shall review 20 advisory board arrangements and 20 other types of Consultant arrangements. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Monitoring Personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with XXXX’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Ethics and Compliance Department for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Par engages U.S.-based HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions other than for speaker programs, researchResearch-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Par shall require all Consultants Par Corporate Integrity Agreement to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- market value analysis conducted by GSKPar. To the extent not already accomplished, within 120 days after the Effective Date, GSK Par shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKPar’s Monitoring Personnel Compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Par Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Par shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting Consultant arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelPar Compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK Par shall amend its policies Policies and procedures Procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK Xxx received the work product generated by the Consultant. Within 120 days after the Effective Date, Par shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 10 percent of Consultant arrangements with HCPs related to Relevant Government Reimbursed Products for each Reporting Period. If Par does not engage any Consultants during a Reporting Period, Par Monitoring Personnel are not required to conduct audits of any Consultant arrangements during that Reporting Period. If Par engages 10 or fewer Consultants in a Reporting Period, Par shall Par Corporate Integrity Agreement consult with OIG to determine the number of Consultant Program Audits for that Reporting Period. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Par Monitoring Personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Par’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Endo engages U.S.-based HCPs or HCIs for services other than for speaker programs, research-related functions, or publication activities that relate to Promotional Functions or to Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Endo shall require all Consultants to enter into written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid Endo Pharmaceuticals Inc. Corporate Integrity Agreement according to a centrally managed, pre-set rate structure that is determined based on a fair- market value analysis conducted by GSKEndo. To the extent not already accomplished, within Within 120 days after the Effective Date, GSK Endo shall establish a process to develop periodic budgeting plans (at least annual budgeting plans plans) that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following yearyear (or period, if more frequent than annual). The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-Consultant- related activities. GSKEndo’s Monitoring Personnel compliance and/or legal personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review process shall be designed to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Endo Policies and ProceduresProcedures and with applicable Federal health care program and FDA requirements. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within Within 120 days after the Effective Date, GSK Endo shall establish a process designed to ensure that a documented needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meetingmeeting(s), and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelEndo compliance and/or legal personnel. To the extent not already accomplished, within Within 120 days after the Effective Date, GSK Endo shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK Endo received the work product generated by the Consultant. Within 120 days after the Effective Date, Endo shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 15 Consultant arrangements with HCPs. The Consultant Program Audits shall include at least 6 advisory board programs and 9 professional services agreements with HCPs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Endo Pharmaceuticals Inc. Corporate Integrity Agreement Endo Monitoring Personnel shall conduct the Consultant Program Audits by reviewing needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Endo's Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Officer or designee for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Shire engages U.S.-based U.S.-licensed HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions other than for speaker programs, research-related activitiesfunctions, or publication activities that relate to one or more Covered Functions (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Shire shall require all Consultants to enter into written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKShire. To the extent not already accomplished, within 120 days after the Effective Date, GSK Shire shall establish a process to develop periodic budgeting plans (at least annual budgeting plans plans) that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following yearyear (or period, if more frequent than annual). The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKShire’s Monitoring Personnel compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be designed to ensure that Consultant arrangements and related events are used for legitimate purposes in Shire North American Group, Inc. Corporate Integrity Agreement accordance with applicable GSK Shire Policies and ProceduresProcedures and with applicable Federal health care program and FDA requirements. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Shire shall establish a process designed to ensure that a documented needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelShire compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK Shire shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK Xxxxx received the work product generated by the Consultant. Within 120 days after the Effective Date, Shire shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 40 Consultant arrangements with HCPs. The Consultant Program Audits shall include at least 30 advisory board programs and 10 professional services agreements with HCPs. In connection with the Consultant Monitoring Program, Shire Monitoring Personnel shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Shire Monitoring Personnel shall conduct the Consultant Program Audits by reviewing needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Shire's Policies and Procedures. Results from the Shire North American Group, Inc. Corporate Integrity Agreement Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the CCRO (or designee) for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Allergan engages U.S.-based HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions Functions, other than for speaker programs, programs or research-related activities, or publication activities functions (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Allergan shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Allergan shall continue to maintain a centralized electronic system through BEACON where all such Consultant arrangements are administered. BEACON shall establish controls regarding eligibility and qualifications of Consultants shall be and requires that Consultants are paid according to a centrally managed, pre-set rate structure that is determined based on fair market value. Allergan shall maintain a fair- market value analysis comprehensive list of Consultants through BEACON. In addition, through BEACON, Allergan shall track and review the aggregate amount paid to each Consultant in connection with Consultant arrangements relating to Government Reimbursed Products conducted by GSKduring each Reporting Period. To the extent not already accomplished, within 120 150 days after the Effective Date, GSK Allergan shall establish a process to develop annual budgeting operating plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The Such annual Consultant budgeting operating plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSK’s Monitoring Personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK shall establish a process to ensure that include a needs assessment has been completed (or business rationale form) to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, meeting and a description of the proposed work to be done and type of work product to be generated.) ). Any deviations from the Consultant budgeting operating plans shall be documented in the needs assessment form (or business rationale form) and shall be subject to review and approval by GSK Monitoring PersonnelAllergan compliance personnel. The annual operating plans shall also identify the budgeted amounts to be spent on Consultant-related activities. Allergan’s compliance personnel shall be involved in the review and approval of such operating plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable Allergan Policies and Procedures. To the extent not already accomplished, within 120 150 days after the Effective Date, GSK Allergan shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK Allergan received the work product generated by the Consultant. Within 150 days after the Effective Date, Allergan shall establish a Consultant Monitoring Program through which it shall conduct live monitoring for each Reporting Period (Consultant Program Observations) of at least 30 Consultant arrangements with HCPs. The Consultant Program Observations shall include live monitoring of at least 10 advisory board programs and monitoring of 20 other professional services agreements with HCPs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Allergan compliance personnel conducting the Consultant Program Observations shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Allergan’s Policies and Procedures. Results from the Consultant Program Observations, including the identification of potential violations of policies, shall be compiled and reported to the Corporate Compliance Department for review and follow-up, as appropriate.

Consultant Arrangement Activities. To the extent that GSK Forest engages U.S.-based U.S.- based HCPs or HCIs for services that relate to Promotional Functions or to and Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Forest shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that which incorporates appropriate objective criteria and is determined based on a fair- fair-market value analysis conducted by GSKForest. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKForest’s Monitoring Personnel Compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Forest Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelForest Compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall amend its policies and procedures in a manner designed to ensure that each Consultant performed performs the work for which the Consultant was is engaged and that, as applicable, GSK received Forest receives the work product generated by the Consultant. Within 120 days after the Effective Date, Forest shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period Corporate Integrity Agreement Forest Laboratories, Inc. (Consultant Program Audits) of at least 30 Consultant arrangements with HCPs. The Consultant Program Observations shall include live monitoring of at least 10 advisory board programs and monitoring of 20 other professional services agreements with HCPs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk- based targeting approach and on a sampling approach. Forest personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Forest’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Forest engages U.S.-based U.S.- based HCPs or HCIs for services that relate to Promotional Functions or to and Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Forest shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that which incorporates appropriate objective criteria and is determined based on a fair- fair-market value analysis conducted by GSKForest. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKXxxxxx’s Monitoring Personnel Compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Forest Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelForest Compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall amend its policies and procedures in a manner designed to ensure that each Consultant performed performs the work for which the Consultant was is engaged and that, as applicable, GSK received Xxxxxx receives the work product generated by the Consultant. Within 120 days after the Effective Date, Forest shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period Corporate Integrity Agreement Forest Laboratories, Inc. (Consultant Program Audits) of at least 30 Consultant arrangements with HCPs. The Consultant Program Observations shall include live monitoring of at least 10 advisory board programs and monitoring of 20 other professional services agreements with HCPs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk- based targeting approach and on a sampling approach. Forest personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Forest’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Shire engages U.S.-based U.S.-licensed HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions other than for speaker programs, research-related activitiesfunctions, or publication activities that relate to one or more Covered Functions (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Shire shall require all Consultants to enter into written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKShire. To the extent not already accomplished, within 120 days after the Effective Date, GSK Shire shall establish a process to develop periodic budgeting plans (at least annual budgeting plans plans) that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following yearyear (or period, if more frequent than annual). The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKShire’s Monitoring Personnel compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be designed to ensure that Consultant arrangements and related events are used for legitimate purposes in Shire North American Group, Inc. Corporate Integrity Agreement accordance with applicable GSK Shire Policies and ProceduresProcedures and with applicable Federal health care program and FDA requirements. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Shire shall establish a process designed to ensure that a documented needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelShire compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK Shire shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK Shire received the work product generated by the Consultant. Within 120 days after the Effective Date, Shire shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 40 Consultant arrangements with HCPs. The Consultant Program Audits shall include at least 30 advisory board programs and 10 professional services agreements with HCPs. In connection with the Consultant Monitoring Program, Shire Monitoring Personnel shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Shire Monitoring Personnel shall conduct the Consultant Program Audits by reviewing needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Shire's Policies and Procedures. Results from the Shire North American Group, Inc. Corporate Integrity Agreement Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the CCRO (or designee) for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Forest engages U.S.-based HCPs or HCIs for services that relate to Promotional Functions or to and Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Forest shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that which incorporates appropriate objective criteria and is determined based on a fair- fair-market value analysis conducted by GSKForest. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKForest’s Monitoring Personnel Compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Forest Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelForest Compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall amend its policies and procedures in a manner designed to ensure that each Consultant performed performs the work for which the Consultant was is engaged and that, as applicable, GSK received Forest receives the work product generated by the Consultant. Within 120 days after the Effective Date, Forest shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 30 Consultant arrangements with HCPs. The Consultant Program Observations shall include live monitoring of at least 10 advisory board programs and monitoring of 20 other professional services agreements with HCPs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Forest personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Forest’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Baxano Surgical engages U.S.-based HCPs or HCIs for services that relate to Promotional Functions or to and Product Services Related Functions other than for speaker programs, research-related activities, or publication activities programs (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as “Consultants. GSK .” Baxano Surgical shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKBaxano Surgical. To the extent not already accomplished, within Within 120 days after the Effective Date, GSK Baxano Surgical shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKBaxano Surgical’s Monitoring Personnel compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Baxano Surgical Policies and ProceduresProcedures and Federal health care program and FDA requirements. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within Within 120 days after the Effective Date, GSK Baxano Surgical shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelBaxano Surgical compliance personnel. To the extent not already accomplished, within Within 120 days after the Effective Date, GSK Baxano Surgical shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK Baxano Surgical received the work product generated by the Consultant. Within 120 days after the Effective Date, Baxano Surgical shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 10 percent of Consultant arrangements with HCPs. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Baxano Surgical compliance personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Baxano Surgical’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Consultant Arrangement Activities. To the extent that GSK Par engages U.S.-based HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions other than for speaker programs, researchResearch-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK Par shall require all Consultants Par Corporate Integrity Agreement to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- market value analysis conducted by GSKPar. To the extent not already accomplished, within 120 days after the Effective Date, GSK Par shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSKPar’s Monitoring Personnel Compliance personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Par Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Par shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting Consultant arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring PersonnelPar Compliance personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK Par shall amend its policies Policies and procedures Procedures in a manner designed to ensure that each Consultant performed the work for which the Consultant was engaged and that, as applicable, GSK Par received the work product generated by the Consultant. Within 120 days after the Effective Date, Par shall establish a Consultant Monitoring Program through which it shall conduct audits for each Reporting Period (Consultant Program Audits) of at least 10 percent of Consultant arrangements with HCPs related to Relevant Government Reimbursed Products for each Reporting Period. If Par does not engage any Consultants during a Reporting Period, Par Monitoring Personnel are not required to conduct audits of any Consultant arrangements during that Reporting Period. If Par engages 10 or fewer Consultants in a Reporting Period, Par shall Par Corporate Integrity Agreement consult with OIG to determine the number of Consultant Program Audits for that Reporting Period. The Consultant Monitoring Program shall review Consultant arrangements both on a risk-based targeting approach and on a sampling approach. Par Monitoring Personnel conducting the Consultant Program Audits shall review needs assessment documents, consultant contracts, and materials relating to the program or work of the Consultant (including work product resulting from any program or event), in order to assess whether the programs and arrangements were conducted in a manner consistent with Par’s Policies and Procedures. Results from the Consultant Program Audits, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow-up as appropriate.