Common use of Research-Related Activities Clause in Contracts

Research-Related Activities. To the extent that GSK engages or supports U.S.- based HCPs or HCIs to conduct Research (as defined above in Section III.B.3.u), such HCPs and HCIs shall be referred to collectively as “Researchers”. GSK shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be given, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement 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 an annual budgeting plan for Researchers that identifies the business or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK Policies and Procedures. 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 the Researcher prior to the retention of the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment form (or elsewhere, as appropriate) 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 Researcher performed the work for which the Researcher was engaged.

Research-Related Activities. To the extent that GSK AstraZeneca or any AstraZeneca Affiliate (hereafter in this Section III.K.2, collectively “AstraZeneca”) engages or supports U.S.- based U.S.-based HCPs or HCIs to conduct Research (as defined above in Section III.B.3.u)post-marketing research or to the extent that AstraZeneca provides financial and other support to HCPs or HCIs for ISSs, such HCPs and HCIs shall be referred to collectively as “Researchers”. GSK AstraZeneca shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be givenpaid, and compliance obligations Corporate Integrity Agreement AstraZeneca for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement 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 an annual budgeting plan for Researchers that identifies the business or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel AstraZeneca 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK AstraZeneca Policies and Procedures. 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 has been completed to justify the retention of the Researcher prior to the retention of the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment form (or elsewhere, as appropriate) 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 Researcher performed the work for which the Researcher was engaged. Within 120 days after the Effective Date, AstraZeneca shall establish a Researcher Monitoring Program through which it shall conduct audits for each Reporting Period (Researcher Program Audits) of at least 30 Researcher arrangements with HCPs or HCIs. Of the Researcher Program Audits, at least 20 shall pertain to ISSs and 10 shall pertain to post-marketing studies. The Researcher Monitoring Program shall review Researcher arrangements both on a risk-based targeting approach and on a sampling approach. AstraZeneca U.S. compliance personnel conducting the Researcher Program Audits shall Corporate Integrity Agreement AstraZeneca review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by AstraZeneca and performed by the Researchers in a manner consistent with AstraZeneca’s Policies and Procedures. Results from the Researcher Program Audits, including identification of potential violations of policies, shall be compiled and reported to the U.S. Compliance Department for review and follow-up as appropriate.

Research-Related Activities. To the extent that GSK Par engages or supports U.S.- based HCPs or HCIs to conduct post-marketing clinical trials or other types of Research (as defined above in Section III.B.3.u)relating to Relevant Government Reimbursed Products, such HCPs and HCIs shall be referred to collectively as “Researchers”. GSK Par shall require all Researchers to enter written agreements describing the scope of the clinical research or other work Research to be performed, the fees to be paid or support to be given, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKPar. To the extent not already accomplishedIf Par engages or supports Researchers, within 120 days after the Effective Date, GSK Par shall establish an annual budgeting plan for Researchers that identifies the business or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel Par 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK Par Policies and Procedures. To the extent not already accomplishedIf Par engages or supports Researchers, 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 the Researcher prior to the retention of the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research Research arrangement (including, for example, information about the Par Corporate Integrity Agreement numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by GSK Monitoring PersonnelPar Compliance personnel. To the extent not already accomplishedIf Par engages or supports Researchers, within 120 90 days after the Effective Dateof beginning this program, GSK Par shall amend its policies Policies and procedures Procedures in a manner designed to ensure that each Researcher performed the work for which the Researcher was engaged.

Research-Related Activities. To the extent that GSK BIPI engages or supports U.S.- based U.S.-based HCPs or HCIs to conduct Research post-marketing studies (as defined above in Section III.B.3.uincluding post-marketing clinical studies), or post-marketing IISs related to Government Reimbursed Products, such HCPs and HCIs shall be referred to collectively as “Researchers”. GSK BIPI shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be givenpaid, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement 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 an annual budgeting plan for Researchers that identifies the business or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel BIPI 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK BIPI Policies and Procedures. 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 the Researcher prior to the retention of the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment form this process (or elsewhere, as appropriate) 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 Researcher performed the work for which the Researcher was engaged. Within 120 days after the Effective Date, BIPI shall establish a Researcher Monitoring Program through which it shall conduct audits for each Reporting Period (Researcher Program Audits) of at least 20 Researcher arrangements with HCPs or HCIs. The Researcher Monitoring Program shall review Researcher arrangements both on a risk-based targeting approach and on a sampling approach. Monitoring Personnel conducting the Researcher Program Audits shall review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by XXXX and performed by the Researchers in a manner consistent with XXXX’s Policies and Procedures. Results from the Researcher Program Audits, including identification of potential violations of policies, shall be compiled and reported to the Ethics and Compliance Department for review and follow-up as appropriate.

Research-Related Activities. To the extent that GSK Forest engages or supports U.S.- based provides funding or other support to U.S.-based HCPs or HCIs to conduct Research (as defined above in Section III.B.3.u)Phase IV post-marketing clinical studies on Government Reimbursed Products, including, but not limited to, IITs, such HCPs and HCIs shall be referred to collectively as “Researchers”. GSK .” Forest shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be givenpaid, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKForest. This fair-market analysis shall be incorporated into guidelines that are used in the review, approval, and funding of Researchers’ activities. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish an annual budgeting plan for Researchers that identifies the business or and/or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel Forest 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK Forest Policies and Procedures. 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 the Researcher prior to the retention of or the provision of funding or other support to the Researcher. The needs assessment shall identify the business or and/or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment form (or elsewhere, as appropriate) 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 Researcher performed performs the work for which the Researcher was is engaged. Within 120 days after the Effective Date, Forest shall establish a Researcher Monitoring Program through which it shall conduct audits for each Reporting Period (Researcher Program Audits) of at least 30 Researcher arrangements with HCPs or HCIs. The Researcher Program Audits shall review at least 20 IITs and at least 10 other post-marketing Researcher arrangements. The Researcher Monitoring Program shall review Researcher arrangements both on a risk-based targeting approach and on a sampling approach. Forest personnel conducting the Researcher Program Audits shall review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by Forest and performed by the Researchers in a manner consistent with Forest’s Policies and Procedures. Results from the Researcher Program Audits, including identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Research-Related Activities. To the extent that GSK engages or supports Novartis compensates U.S.- based HCPs or HCIs or provides financial or other support to conduct Research (as defined above in Section III.B.3.u)Phase IV post- marketing clinical studies including but not limited to ISSs, such HCPs and HCIs this shall be referred to collectively as “Researchers”Research” for purposes of this CIA. GSK Novartis shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be givenpaid, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKNovartis. To the extent not already accomplished, within 120 days after the Effective Date, GSK Novartis shall establish an annual budgeting plan for Researchers Research that identifies the business or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher Research engagements and activities to occur during the year, as applicable. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel Novartis 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK Novartis Policies and Procedures. To the extent not already accomplished, within 120 days after the Effective Date, GSK Novartis shall establish a process to ensure that a needs assessment has been completed to justify the retention of the Researcher prior to the retention of the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher Research budgeting plans shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by GSK Monitoring PersonnelNovartis U.S. compliance personnel. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK Novartis shall amend its policies and procedures in a manner designed to ensure that each Researcher performed the work for which the Researcher was engaged. Within 120 days after the Effective Date, Novartis shall establish a Research Monitoring Program through which it shall conduct audits for each Reporting Period (Researcher Program Audits) of at least 20 Researcher arrangements with HCPs or HCIs. The Research Monitoring Program shall review Research arrangements both on a risk- based targeting approach and on a sampling approach. Novartis U.S. compliance personnel conducting the Research Program Audits shall review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by Novartis and performed by the Researchers in a manner consistent with Novartis’ Policies and Procedures. Results from the Research Program Audits, including identification of potential violations of policies, shall be compiled and reported to the U.S. Compliance Department for review and follow-up as appropriate.

Research-Related Activities. To the extent that GSK Forest engages or supports U.S.- based provides funding or other support to U.S.-based HCPs or HCIs to conduct Research (as defined above in Section III.B.3.u)Phase IV post-marketing clinical studies on Government Reimbursed Products, including, but not limited to, IITs, such HCPs and HCIs shall be referred to collectively as “Researchers”. GSK .” Forest shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be givenpaid, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKForest. This fair-market analysis shall be incorporated into guidelines that are used in the review, approval, and funding of Researchers’ activities. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish an annual budgeting plan for Researchers that identifies the business or and/or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel Forest 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK Forest Policies and Procedures. 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 the Researcher prior to the retention of or the provision of funding or other support to the Researcher. The needs assessment shall identify the business or Corporate Integrity Agreement Forest Laboratories, Inc. and/or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment form (or elsewhere, as appropriate) 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 Researcher performed performs the work for which the Researcher was is engaged. Within 120 days after the Effective Date, Forest shall establish a Researcher Monitoring Program through which it shall conduct audits for each Reporting Period (Researcher Program Audits) of at least 30 Researcher arrangements with HCPs or HCIs. The Researcher Program Audits shall review at least 20 IITs and at least 10 other post- marketing Researcher arrangements. The Researcher Monitoring Program shall review Researcher arrangements both on a risk-based targeting approach and on a sampling approach. Forest personnel conducting the Researcher Program Audits shall review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by Forest and performed by the Researchers in a manner consistent with Forest’s Policies and Procedures. Results from the Researcher Program Audits, including identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Research-Related Activities. To the extent that GSK Endo or EPI engages or supports U.S.- based U.S.-based HCPs or HCIs to conduct Research (as defined above in Section III.B.3.u), II.C.8 above) such HCPs and HCIs shall be referred to collectively as “"Researchers”". GSK Endo shall require all Researchers to enter into written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be givenpaid, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKEndo or industry standard databases or tools. To the extent not already accomplished, within Within 120 days after the Effective Date, GSK Endo shall establish an annual budgeting plan for Researchers that identifies the business or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel Endo compliance personnel and/or legal shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this This review shall be designed to ensure that Research arrangements and related events are used for legitimate purposes in accordance with GSK Endo Policies and ProceduresProcedures and with applicable Federal health care program and FDA requirements. 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 needs assessment has been completed to justify the retention of the Researcher prior to the retention of the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans Endo Pharmaceuticals Inc. Corporate Integrity Agreement shall be documented in the needs assessment form (or elsewhere, as appropriate) 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 Researcher performed the work for which the Researcher was engaged. Within 120 days after the Effective Date, Endo shall establish a Researcher Monitoring Program through which it shall conduct audits for each Reporting Period (Researcher Program Audits) of at least 5 Researcher arrangements with HCPs or HCIs. The Researcher Monitoring Program shall review Researcher arrangements both on a risk-based targeting approach and on a sampling approach. Endo Monitoring Personnel shall review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by Xxxx and performed by the Researchers in a manner consistent with Endo's Policies and Procedures. Results from the Researcher Program Audits, including identification of potential violations of policies, shall be compiled and reported to the Compliance Officer (or designee) for review and follow-up as appropriate.

Research-Related Activities. To the extent that GSK engages Allergan or supports U.S.- based any Allergan Affiliate (hereafter in this Section III.K.2, collectively “Allergan”) provides funding or other support to U.S.-based HCPs or HCIs to conduct Research (as defined above in Section III.B.3.u)Phase IV post-marketing studies or IITs, such HCPs and HCIs shall be referred to collectively as “Researchers”. GSK Allergan shall require all Researchers to enter written agreements describing the scope of the clinical research or other work to be performed, the fees to be paid or support to be givenpaid, and compliance obligations for the Researchers. Researchers retained to conduct Research shall be paid GlaxoSmithKline LLC Corporate Integrity Agreement according to a centrally managed, pre-set rate structure that is determined based on a fair- fair-market value analysis conducted by GSKAllergan. This fair-market value analysis shall be incorporated into guidelines that are used in the review, approval, and funding of Researchers’ activities. Documentation of such review, approval, and funding activities shall be maintained by Allergan Medical Affairs. To the extent not already accomplished, within 120 150 days after the Effective Date, GSK Allergan shall establish an annual budgeting plan for Researchers that identifies the business or scientific need or scientific opportunity for, and the estimated numbers of, the various Researcher engagements and activities to occur during the year. The annual Researcher budgeting plan shall also identify the budgeted amounts to be spent on Researcher-related activities during the year. GSK Monitoring Personnel Allergan Medical Affairs personnel, in consultation with 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 Research arrangements and related events are used for legitimate purposes in accordance with GSK Allergan Policies and Procedures. To the extent not already accomplished, within 120 150 days after the Effective Date, GSK Allergan shall establish a process to ensure that each Researcher has submitted a needs assessment has been completed to justify the retention of the Researcher prior to the retention provision of funding or other support to the Researcher. The needs assessment shall identify the business or scientific need for the information to be provided by the Researcher and provide specific details about the research arrangement (including, for example, information about the numbers and qualifications of the HCPs or HCIs to be engaged, a description of the proposed research to be done (including the research protocol) and type of work product to be generated). Any deviations from the Researcher budgeting plans shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by GSK Monitoring Personnel. 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 Researcher performed the work for which the Researcher was engagedprovided funding or other support. Within 150 days after the Effective Date, Allergan shall establish a Researcher Monitoring Program through which it shall conduct monitoring for each Reporting Period of at least 20 Researcher arrangements with HCPs or HCIs. The Researcher Monitoring Program shall review Researcher arrangements both on a risk-based targeting approach and on a sampling approach. Allergan compliance personnel conducting the Researcher Monitoring Program shall review needs assessment documents, proposal and/or protocol documents, approval documents, contracts, and payments in order to assess whether the programs and arrangements were supported by Allergan and performed by the Researchers in a manner consistent with Allergan’s Policies and Procedures. Results from the Researcher Monitoring Program, including identification of potential violations of policies, shall be compiled and reported to the Corporate Compliance Department for review and follow-up as appropriate.