Common use of Consulting Arrangement Activities Clause in Contracts

Consulting Arrangement Activities. To the extent that Indivior engages HCPs for services 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 shall be referred to herein as Consultants. a. Indivior shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis. b. Within 90 days after the Effective Date, Indivior shall establish a process and an Indivior Consultant Review Committee to review and approve each business needs assessment for each Consultant arrangement. Indivior compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagement, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committee. The purpose of the Consultant Review Committee review shall be to ensure that Consultant arrangements and activities are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements. c. Within 90 days after the Effective Date, Indivior shall establish a process that requires an HCP nomination to be submitted to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination shall identify the criteria and business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the qualifications of the HCP to be engaged, a description of the proposed work to be done, the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination shall be documented in the centralized consultant review system and shall be subject to review and approval by Indivior compliance personnel. d. Within 90 days after the Effective Date, Indivior 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, Indivior received the work product generated by the Consultant. e. Within 90 days after the Effective Date, Indivior shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Audits) of at least ten Consultant arrangements with HCPs during each Reporting Period. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations), 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 Indivior’s Policies and Procedures. Results from the Consultant Arrangement Audits, including the identification of potential violations of Indivior policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.

Consulting Arrangement Activities. To the extent that Indivior engages HCPs for services 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 shall be referred to herein as Consultants. a. (a) Indivior shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis. b. (b) Within 90 days after the Effective Date, Indivior shall establish a process and an Indivior Consultant Review Committee to review and approve each business needs assessment for each Consultant arrangement. Indivior compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagement, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committee. The purpose of the Consultant Review Committee review shall be to ensure that Consultant arrangements and activities are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements. c. (c) Within 90 days after the Effective Date, Indivior shall establish a process that requires an HCP nomination to be submitted to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination shall identify the criteria and business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the qualifications of the HCP to be engaged, a description of the proposed work to be done, the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination shall be documented in the centralized consultant review system and shall be subject to review and approval by Indivior compliance personnel. d. (d) Within 90 days after the Effective Date, Indivior 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, Indivior received the work product generated by the Consultant. e. (e) Within 90 days after the Effective Date, Indivior shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Audits) of at least ten Consultant arrangements with HCPs during each Reporting Period. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations), 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 Indivior’s Policies and Procedures. Results from the Consultant Arrangement Audits, including the identification of potential violations of Indivior policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.

Consulting Arrangement Activities. To the extent that Indivior Avanir engages HCPs for services 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 shall be referred to herein as Consultants.Consultants.‌ a. Indivior Avanir shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis.analysis either conducted by Xxxxxx or commissioned by Xxxxxx using third party consultants with experience at conducting fair market value analyses.‌ b. Within 90 120 days after the Effective Date, Indivior Avanir shall establish a process and to develop an Indivior Consultant Review Committee to review and approve each annual budgeting plan that identifies the business needs assessment for each for, and the estimated numbers of, the various Consultant arrangementengagements and activities to occur during the following year. Indivior The annual Consultant budgeting plan shall also identify the budgeted amounts to be spent on Consultant-related activities. Avanir compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagementsuch plans, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committeeplan. The purpose of the Consultant Review Committee this review shall be to ensure that Consultant arrangements and activities related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Avanir Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements.Procedures.‌ c. Within 90 120 days after the Effective Date, Indivior Xxxxxx shall establish a process to ensure that requires an HCP nomination to be submitted a needs assessment has been completed to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination needs assessment shall identify the criteria and business need for the retention of the Consultant Consultant‌ and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCP HCPs and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done, done and the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination the Consultant budgeting plans shall be documented in the centralized consultant review system needs assessment form and shall be subject to review and approval by Indivior Avanir compliance personnel.personnel.‌ d. Within 90 120 days after the Effective Date, Indivior Avanir 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, Indivior Xxxxxx received the work product generated by the Consultant.Consultant.‌ e. Within 90 120 days after the Effective Date, Indivior Avanir shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Program Audits) of at least ten Consultant arrangements 5, or 10% of the total number of consultant programs with HCPs during each Reporting Period, whichever is a larger number. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- risk-based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations)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 IndiviorAvanir’s Policies and Procedures. Results from the Consultant Arrangement Program Audits, including the identification of potential violations of Indivior Avanir policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.appropriate.‌

Consulting Arrangement Activities. To the extent that Indivior Arthrex engages HCPs HCPs, either directly or indirectly (e.g., through local distributors on behalf of Arthrex), for services other than for speaker programsprograms (e.g., Researchtraining and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, authorship activities, and any other financial engagement or publication activities (e.g., as a member of arrangement with an advisory board or to attend consultant meetingsHCP), such HCPs shall be referred to herein as Consultants.. Within 90 days of the Effective Date, Arthrex shall:‌‌ a. Indivior shall require Require all Consultants to enter written agreements describing the scope of work to be performed, the consultant fees to be paid, and compliance obligations requirements for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a third-party an independent fair-market value analysis.analysis.‌ b. Within 90 days after the Effective Date, Indivior shall establish Establish a process and to develop an Indivior Consultant Review Committee to review and approve each annual budgeting plan that specifies (i) the business needs assessment for each for, and the estimated numbers of, the various Consultant arrangementengagements and activities to occur during the following year and (ii) the budgeted amounts to be spent on Consultant-related activities. Indivior Arthrex compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagementsuch plans, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on plan for the Consultant Review Committee. The purpose of the Consultant Review Committee review shall be to ensure ensuring that Consultant arrangements and activities related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Arthrex Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements.Procedures.‌ c. Within 90 days after the Effective Date, Indivior shall establish Establish a process to ensure that requires an HCP nomination to be submitted a needs assessment has been completed to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination needs assessment shall identify the criteria and 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 HCP HCPs and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done, done and the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination the Consultant budgeting plans shall be documented in the centralized consultant review system needs assessment form and shall be subject to review and approval by Indivior Arthrex compliance personnel.personnel.‌‌ d. Within 90 days after the Effective Date, Indivior shall amend 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, Indivior received Arthrex receives the work product generated by the Consultant. e. Within 90 days after the Effective Date, Indivior shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Audits) of at least ten Consultant arrangements with HCPs during each Reporting Period. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations), 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 Indivior’s Policies and Procedures. Results from the Consultant Arrangement Audits, including the identification of potential violations of Indivior policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.Consultant.‌

Consulting Arrangement Activities. To the extent that Indivior USWM engages HCPs for services 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 shall be referred to herein as Consultants.Consultants.‌ a. Indivior USWM shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis.analysis conducted by USWM.‌ b. Within 90 120 days after the Effective Date, Indivior USWM shall establish a process and to develop an Indivior Consultant Review Committee to review and approve each annual budgeting plan that identifies the business needs assessment for each for, and the estimated numbers of, the various Consultant arrangementengagements and activities to occur during the following year. Indivior The annual Consultant budgeting plan shall also identify the budgeted amounts to be spent on Consultant-related activities. USWM compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagement, such plans,‌ Corporate Integrity Agreement – USWM including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committeeplan. The purpose of the Consultant Review Committee this review shall be to ensure that Consultant arrangements and activities related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior USWM Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements. c. Within 90 120 days after the Effective Date, Indivior USWM shall establish a process to ensure that requires an HCP nomination to be submitted a needs assessment has been completed to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination needs assessment shall identify the criteria and 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 HCP HCPs and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done, done and the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination the Consultant budgeting plans shall be documented in the centralized consultant review system needs assessment form and shall be subject to review and approval by Indivior USWM compliance personnel.personnel.‌‌ d. Within 90 120 days after the Effective Date, Indivior USWM 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, Indivior USWM received the work product generated by the Consultant.Consultant.‌ e. Within 90 120 days after the Effective Date, Indivior USWM shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Program Audits) of at least ten Consultant arrangements 3 consultant programs with HCPs during each Reporting Period. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- risk-based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations)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 the‌ Corporate Integrity Agreement – USWM programs and arrangements were conducted in a manner consistent with IndiviorUSWM’s Policies and Procedures. Results from the Consultant Arrangement Program Audits, including the identification of potential violations of Indivior USWM policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.

Consulting Arrangement Activities. To the extent that Indivior Aegerion engages HCPs for services other than for speaker programs, Research-related activities, or publication activities programs (e.g., as a member of an advisory board board, to attend a consultant meeting, or to attend consultant meetingsconduct Research), such HCPs shall be referred to herein as Consultants. a. Indivior . Aegerion shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis. b. analysis conducted by or for Aegerion. Within 90 days after the Effective Date, Indivior Aegerion shall establish a process and to develop an Indivior Consultant Review Committee to review and approve each annual budgeting plan that identifies the business needs assessment for each for, and the estimated numbers of, the various Consultant arrangementengagements and activities to occur during the following year. Indivior The annual Consultant budgeting plan shall also identify the budgeted amounts to be spent on Consultant-related activities. Aegerion compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagementsuch plans, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committeeplan. The purpose of the Consultant Review Committee this review shall be to ensure that Consultant arrangements and activities related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Aegerion Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements. c. Within 90 days after the Effective Date, Indivior Aegerion shall establish a process to ensure that requires an HCP nomination to be submitted a needs assessment has been completed to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination needs assessment shall identify the criteria and 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 HCP HCPs and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done, done and the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination the Consultant budgeting plans shall be documented in the centralized consultant review system needs assessment form and shall be subject to review and approval by Indivior Aegerion compliance personnel. d. . Within 90 120 days after the Effective Date, Indivior Aegerion shall confirm or 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, Indivior Aegerion received the work product generated by the Consultant. e. . Within 90 120 days after the Effective Date, Indivior Aegerion shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Program Audits) of at least ten Consultant 15 engagements/arrangements with HCPs during each Reporting Period. The Consultant Monitoring Program shall judgmentally select Consultant arrangements for review using either a risk- based targeting approach or a random sampling approachreview. However, the numbers of the various types of arrangements to be reviewed (e.g., advisory boards, non-promotional speaker programs, etc.) shall be proportional to the numbers of the types of arrangements. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations)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 IndiviorAegerion’s Policies and Procedures. Results from the Consultant Arrangement Program Audits, including the identification of potential violations of Indivior Aegerion policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.

Consulting Arrangement Activities. To the extent that Indivior Daiichi engages U.S.-based U.S.-licensed HCPs for services other than for speaker programs, Researchresearch-related activities, or publication activities that relate to Promotional Functions or to Product Related Functions (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs shall be referred to herein as Consultants. a. Indivior . Daiichi shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis. b. Within analysis conducted by Daiichi (or a qualified third-party vendor on behalf of Daiichi). To the extent not already accomplished and within 90 days after the Effective Date, Indivior Daiichi shall establish a process and to develop an Indivior Consultant Review Committee to review and approve each annual engagement plan that identifies the business needs assessment for each for, and the estimated numbers of, the various Consultant arrangementengagements and activities to occur during the following year. Indivior The annual Consultant engagement plan shall also identify the budgeted amounts to be spent on Consultant- related activities. Daiichi compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagementsuch plans, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committeeplan. The purpose of the Consultant Review Committee this review shall be to ensure that Consultant arrangements and activities related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Daiichi Policies and Procedures. Indivior shall maintain To the process extent not already accomplished and within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements. c. Within 90 days after the Effective Date, Indivior Daiichi shall establish a process to ensure that requires an HCP nomination to be submitted a needs assessment has been completed to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination needs assessment shall identify the criteria and 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 HCP HCPs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done, done and the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination the Consultant budgeting plans shall be documented in the centralized consultant review system needs assessment form and shall be subject to review and approval by Indivior Daiichi compliance personnel. d. . Within 90 days after the Effective Date, Indivior Daiichi 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, Indivior Daiichi received the work product generated by the Consultant. e. . Within 90 days after the Effective Date, Indivior Daiichi shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Program Audits) of at least ten Consultant arrangements 30 consultant programs with HCPs during each Reporting Period. The Consultant Program Audits shall include at least 10 advisory boards and 20 professional services arrangements with HCPs. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- risk-based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations)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 IndiviorDaiichi’s Policies and Procedures. Results from the Consultant Arrangement Program Audits, including the identification of potential violations of Indivior Daiichi policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.

Consulting Arrangement Activities. To the extent that Indivior Insys engages HCPs for services 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 shall be referred to herein as Consultants.Consultants.‌ a. Indivior Insys shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis.analysis conducted by Insys.‌ b. Within 90 120 days after the Effective Date, Indivior Insys shall establish a process and to develop an Indivior Consultant Review Committee to review and approve each annual budgeting plan that identifies the business needs assessment for each for, and the estimated numbers of, the various Consultant arrangementengagements and activities to occur during the following year. Indivior The annual Consultant budgeting plan shall also identify the budgeted amounts to be spent on Consultant-related activities. Insys compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagementsuch plans, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committeeplan. The purpose of the Consultant Review Committee this review shall be to ensure that Consultant arrangements and activities related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Insys Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements.Procedures.‌ c. Within 90 120 days after the Effective Date, Indivior Insys shall establish a process to ensure that requires an HCP nomination to be submitted a needs assessment has been completed to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination needs assessment shall identify the criteria and 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 HCP HCPs and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done, done and the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination the Consultant budgeting plans shall be be‌‌ documented in the centralized consultant review system needs assessment form and shall be subject to review and approval by Indivior Insys compliance personnel. d. Within 90 120 days after the Effective Date, Indivior Insys 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, Indivior Insys received the work product generated by the Consultant.Consultant.‌ e. Within 90 120 days after the Effective Date, Indivior Insys shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Program Audits) of at least ten Consultant arrangements 15 consultant programs with HCPs during each Reporting Period. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- risk-based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations)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 IndiviorInsys’s Policies and Procedures. Results from the Consultant Arrangement Program Audits, including the identification of potential violations of Indivior Insys policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.appropriate.‌

Consulting Arrangement Activities. To the extent that Indivior ACell engages HCPs for services other than for speaker programs, Research-related activities, or publication activities programs (e.g., as a Key Opinion Leader, member of an advisory board board, or to attend consultant meetings), such HCPs shall be referred to herein as “Consultants.”‌ a. Indivior ACell shall require all Consultants to enter written agreements describing the scope of work to be performed, the consultant 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 third-party fair-market value analysis.analysis conducted by or for ACell.‌ b. Within 90 120 days after the Effective Date, Indivior ACell shall establish a process and to develop an Indivior Consultant Review Committee to review and approve each annual budgeting plan that identifies the business needs assessment for each for, and the estimated numbers of, the various Consultant arrangementengagements and activities to occur during the following year. Indivior compliance The annual Consultant budgeting plan shall also identify the budgeted amounts to be spent on‌ Consultant-related activities. ACell Compliance personnel shall chair the Consultant Review Committee and shall be involved in the review and approval of the business needs assessment for each Consultant engagementsuch plans, including any subsequent modification of an approved Consulting activity. The sales and marketing functions shall not be represented on the Consultant Review Committeeplan. The purpose of the Consultant Review Committee this review shall be to ensure that Consultant arrangements and activities related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior ACell Policies and Procedures. Indivior shall maintain the process within its annual budget planning cycle that requires oversight and approval by senior management responsible for annual budget setting, including any budget allocated toward Consultant engagements. c. Within 90 120 days after the Effective Date, Indivior ACell shall establish a process to ensure that requires an HCP nomination to be submitted a needs assessment has been completed to justify the retention of a named Consultant prior to the retention of the named Consultant. The HCP nomination needs assessment shall identify the criteria and 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 HCP HCPs and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done, done and the type of work product to be generated, and, based on a FMV analysis, the proposed amount to be paid to the Consultant). Any deviations from an approved HCP nomination the Consultant budgeting plans shall be documented in the centralized consultant review system needs assessment form and shall be subject to review and approval by Indivior ACell compliance personnel.personnel.‌‌ d. Within 90 120 days after the Effective Date, Indivior ACell 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, Indivior XXxxx received the work product generated by the Consultant. e. Within 90 days after the Effective Date, Indivior shall establish a Consultant Monitoring Program through which it shall conduct audits (Consultant Arrangement Audits) of at least ten Consultant arrangements with HCPs during each Reporting Period. The Consultant Monitoring Program shall select Consultant arrangements for review using either a risk- based targeting approach or a random sampling approach. Monitoring Personnel shall review Indivior Consultant Review Committee documents (including HCP nominations), 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 Indivior’s Policies and Procedures. Results from the Consultant Arrangement Audits, including the identification of potential violations of Indivior policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow up as appropriate.Consultant.‌