Common use of Speaker Program Activities Clause in Contracts

Speaker Program Activities. With regard to speaker programs, GSK shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK approved materials and may not directly or indirectly promote the product for off-label uses.) GSK shall maintain a centralized electronic system through which all speaker programs are administered. This system shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSK. GSK shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK shall require certified evaluations by sales personnel regarding whether a speaker program complied with GSK requirements, and in the event of non-compliance, GSK shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK shall institute a Speaker Monitoring Program under which GSK compliance or other appropriately trained GSK personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK representative activities during the program to assess whether the programs were conducted in a manner consistent with GSK’s Policies and Procedures. GSK shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard Within 90 days after the Effective Date: a. Indivior shall establish a process to develop an annual budget and needs assessment process that identifies the business needs for, and the estimated numbers of, speaker program activities for the following year. As part of the process, Indivior shall identify the business need for the planned speaker programs and shall collect specific details about the speaker programs (e.g., the expected number of programs, the topics of the programs, and the identity and qualifications of the proposed speakers.) The annual speaker program budget shall identify the total budgeted amounts to be spent on speaker programs. Indivior compliance personnel shall be involved in the review and approval of such plans, GSK including any subsequent modification of approved plans. The purpose of this review shall maintain processes be to ensure that speaker programs and related events (including speaker training events) are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Indivior Policies and Procedures; b. Indivior shall implement a process to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that regarding the speaker may only use GSK of Indivior approved materials and requirements that speakers may not directly or indirectly promote the product for off-label uses.) GSK ). c. Indivior shall maintain establish a centralized electronic system through which to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administered. This system used for legitimate and lawful purposes in accordance with all applicable Federal health care program and FDA requirements. d. Indivior shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require ensure that speakers are paid according to a centrally managed, pre-set rate structure determined based on a third-party fair-market value analysis conducted by GSK. GSK analysis. e. Indivior shall maintain a comprehensive list of speaker program attendees through its a centralized system. In addition, GSK Indivior shall track use a centralized system to handle all logistics and spending associated with speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK shall require certified evaluations by sales personnel regarding whether a speaker program complied with GSK requirements, and in the event of non-compliance, GSK shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK shall institute a Speaker Monitoring Program under which GSK compliance or other appropriately trained GSK personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK representative activities during the program to assess whether the programs were conducted in a manner consistent with GSK’s Policies and Procedures. GSK shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programs, GSK AstraZeneca shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK AstraZeneca approved materials and may not directly or indirectly promote the product for off-label uses.) GSK AstraZeneca shall maintain a centralized electronic system through which all speaker programs are administered. This system shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSKAstraZeneca. GSK AstraZeneca shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK AstraZeneca shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK AstraZeneca shall require certified evaluations by sales representatives or other AstraZeneca personnel regarding whether a speaker program complied with GSK AstraZeneca requirements, and in the event of non-compliance, GSK AstraZeneca shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK AstraZeneca shall institute a Speaker Monitoring Program under which GSK AstraZeneca U.S. compliance or other appropriately trained GSK management Corporate Integrity Agreement AstraZeneca personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) or outside personnel acting on behalf of AstraZeneca shall attend 250 speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK AstraZeneca representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKAstraZeneca’s Policies and Procedures. GSK AstraZeneca shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programs, GSK Endo shall maintain processes implement a process to require all speakers to be qualified, complete training training, and enter into written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK Endo approved materials and may not directly or indirectly promote the product for off-label uses.) GSK Endo shall maintain processes designed to ensure that there is a legitimate need for each speaker program. Endo shall also maintain a centralized electronic system through which all speaker programs are initiated, tracked, and administered. This system shall include controls designed to ensure that speaker programs are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements. The system shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and programs. The controls shall require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-fair market value analysis conducted by GSKEndo. GSK Endo shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK Endo shall track use its Endo Pharmaceuticals Inc. Corporate Integrity Agreement centralized system to handle all logistics and spending associated with the speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Periodprograms. GSK Endo shall require certified evaluations by sales representatives or other Endo personnel regarding whether a speaker program complied with GSK Endo requirements, and or in the event of non-compliance, GSK Endo shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK Endo shall institute a Speaker Monitoring Program under which GSK Endo compliance or other appropriately trained GSK personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the 30 of such programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a random sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Endo representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKEndo’s Policies and Procedures. GSK Endo shall maintain the controls around speaker programs as described above, above and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programs, GSK a. Insys shall maintain processes implement a process to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and concerning compliance obligations for the speakers (including requirements that regarding the speaker may only use GSK of Insys approved materials and requirements that speakers may not directly or indirectly promote the product for off-label uses). These requirements must be specified in a written agreement between Insys and the speaker for any speakers who are not employed by ▇▇▇▇▇.) GSK b. Insys shall maintain establish a centralized centralized, electronic system through which to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administered. This system shall establish controls regarding eligibility used for legitimate and qualifications of speakers lawful purposes in accordance with all applicable Federal health care program and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSK. GSK FDA requirements. c. Insys shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK . d. Insys shall require certified evaluations certifications by sales representatives or other Insys personnel regarding whether that a speaker program complied with GSK Insys requirements, and or in the event of non-compliance, GSK Insys shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK . e. Insys shall institute a Speaker Monitoring Program under which GSK Insys compliance or other appropriately trained GSK Insys personnel or non-employee personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend ten speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on using either a risk-based targeting approach and on or a random sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Insys sales representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKInsys’s Policies and Procedures. GSK Insys shall maintain the controls around speaker programs as described above, above and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programs, GSK shall maintain processes Daiichi has implemented a process to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that regarding the speaker may only use GSK of Daiichi approved materials and requirements that speakers may not directly or indirectly promote the product for off-label unapproved uses.) GSK Daiichi shall maintain establish a centralized centralized, electronic system through which system(s) to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administeredused for legitimate and lawful purposes in accordance with all applicable Federal health care program and FDA requirements. This system The controls shall establish controls regarding eligibility and qualifications of speakers and venues also be designed to ensure that there is a legitimate need for the programs and require speaker programs. Daiichi shall ensure that speakers are paid according to a centrally managed, pre-pre- set rate structure determined based on a fair-market value analysis conducted by GSKDaiichi (or a qualified third-party vendor on behalf of Daiichi). GSK Daiichi shall maintain a comprehensive list of speaker program attendees through its centralized systemelectronic system(s). In addition, GSK Daiichi shall track use its centralized electronic system(s) to handle all logistics and spending associated with speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Periodprograms. GSK Daiichi shall require certified evaluations certifications by sales representatives or other Daiichi personnel regarding whether that a speaker program complied with GSK Daiichi requirements, and or in the event of non-compliance, GSK Daiichi shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK Daiichi shall institute a Speaker Monitoring Program under which GSK Daiichi compliance or other appropriately trained GSK personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend 75 speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on using a risk-risk- based targeting approach and on or a random sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Daiichi sales representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKDaiichi’s Policies and Procedures. GSK Daiichi shall maintain the controls around speaker programs as described above, above and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard Par represents that it currently does not engage in speaker program activities. If Par begins activities in this area, within 90 days after beginning the activity, Par shall notify OIG that it is engaged in the new type of activity and develop and implement a monitoring program for speaker program activity. The Potential IRO Review of these activities is described in Appendix B. This program shall be referred to as the Speaker Monitoring Program. If Par engages in speaker programsprogram activities, GSK Par Corporate Integrity Agreement a. Par shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK Par approved materials and may not directly or indirectly promote the product for off-label uses.) GSK ) b. Par shall maintain a centralized electronic system through which all speaker programs are administered. This system shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSK. GSK Par. c. Par shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK . d. Par shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK . e. Par shall require certified evaluations by sales personnel regarding whether a speaker program complied with GSK Par requirements, and in the event of non-non- compliance, GSK Par shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK . f. Par shall institute a Speaker Monitoring Program under which GSK Par compliance or other appropriately trained GSK Par personnel who are independent from the functional area being monitored (hereinafter “GSK Par Monitoring Personnel”) shall attend speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits at least 10 percent of the such programs (“Speaker Program Audits”). For the first If Par does not conduct any speaker programs during a Reporting Period, GSK shall Par Monitoring Personnel are not required to conduct live audits of 150 speaker programs and for during that Reporting Period. If Par conducts 10 or fewer speaker programs in a Reporting Period, Par shall consult with OIG to determine the subsequent number of Speaker Program Audits in that Reporting Periods, GSK shall conduct live audits of 75 speaker programsPeriod. The programs subject to Speaker Program Audits shall be selected both on a risk-risk- based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the Par Corporate Integrity Agreement program, and GSK Par representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKPar’s Policies and Procedures. GSK Par shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programs, GSK BIPI shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK BIPI approved materials and may not directly or indirectly promote the product for off-label uses.) GSK BIPI shall maintain a centralized electronic system through which all speaker programs are administered. This system shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSKBIPI. GSK BIPI shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK BIPI shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK BIPI shall require certified evaluations the completion of monitoring forms by sales representatives or other BIPI personnel regarding whether a speaker program complied with GSK BIPI requirements, and in the event of non-compliance, GSK BIPI shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK BIPI shall institute a Speaker Monitoring Program under which GSK BIPI compliance personnel or other appropriately trained GSK personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of 75 of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK BIPI representative activities during the program to assess whether the programs were conducted in a manner consistent with GSK▇▇▇▇’s Policies and Procedures. GSK BIPI shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With To the extent not already required, with regard to speaker programs, GSK Forest shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK Forest-approved materials and may not directly or indirectly promote the product for off-label uses.) GSK Forest and/or its designee shall maintain a centralized electronic system systems or processes through which all speaker programs are administered. This system These systems or processes shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, managed pre-set rate structure determined based on a fair-market value analysis conducted by GSKForest. GSK Forest shall maintain a comprehensive list of speaker program attendees through its centralized systemsystems and processes. In addition, GSK Forest shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK Forest shall require certified evaluations by sales representatives or other Forest personnel regarding whether a speaker program complied with GSK Forest requirements, and in the event of non-compliance, GSK Forest shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK Forest shall institute a Speaker Monitoring Program under which GSK compliance Forest Compliance or other appropriately trained GSK management personnel, or outside personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) acting on behalf of Forest, shall attend 175 speaker programs relating to Government Reimbursed Products during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the those programs (Speaker Program Audits). For Sixty percent of the first Reporting Period, GSK programs subject to the Speaker Program Audits shall conduct live audits of 150 speaker be in-office programs and for the subsequent Reporting Periods, GSK forty percent shall conduct live audits of 75 speaker be out-of-office programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Forest representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKForest’s Policies and Procedures. GSK Forest shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programsAs a component of the SMMP, GSK shall maintain processes to require Shire requires that all speakers to be qualified, complete training training, and enter into written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK Shire approved materials and may not directly or indirectly promote the product for off-label uses.) GSK ). Shire shall maintain processes designed to ensure that there is a legitimate need for each speaker program and, by or before December 31, 2014, shall establish a centralized electronic system through which all speaker programs are administeredare, and shall be, administered throughout the term of the CIA. This system shall establish Shire has instituted controls regarding eligibility and qualifications of speakers and venues for the programs and require requires that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-fair market value analysis conducted by GSKShire. GSK Shire shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK Shire tracks and reviews, and shall continue to track and review review, the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK Shire requires, and shall require continue to require, certified evaluations by sales representatives or other Shire personnel regarding whether a speaker program complied with GSK Shire requirements, and in the event of non-compliance, GSK Shire requires, and shall require continue to require, the identification of the policy violation and ensure appropriate follow up activity to address the violation. To As a component of the extent not already accomplishedSMMP, GSK shall institute a Speaker Monitoring Program under which GSK Shire compliance or other appropriately trained GSK personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement Period. Shire will conduct live audits monitoring of the 50 such programs (Speaker Program AuditsMonitoring). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to the Speaker Monitoring Program Audits shall be selected based on both on a risk-based Shire North American Group, Inc. Corporate Integrity Agreement targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Shire representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKShire’s Policies and Procedures. GSK Shire shall maintain the controls around speaker programs as described above, above and shall conduct its Speaker Monitoring Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to If during the term of the CIA, Aegerion institutes the practice of speaker programs, GSK it shall maintain processes comply with the requirements set forth in this Section III.L.3. Aegerion shall implement a process to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that regarding the speaker may only use GSK of Aegerion approved materials and requirements that speakers may not directly or indirectly promote the product for offnon-label approved uses.) GSK Aegerion shall maintain establish a centralized centralized, electronic system through which to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administeredused for legitimate and lawful purposes in accordance with all applicable Federal health care program and FDA requirements. This system The controls shall establish controls regarding eligibility and qualifications of speakers and venues also be designed to ensure that there is a legitimate need for the programs and require speaker programs. Aegerion shall ensure that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSKor for Aegerion. GSK Aegerion shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK Aegerion shall track use its centralized system to handle all logistics and spending associated with speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Periodprograms. GSK Aegerion shall require certified evaluations certifications by sales representatives or other Aegerion personnel regarding whether that a speaker program complied with GSK Aegerion requirements, and or in the event of non-compliance, GSK Aegerion shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK Aegerion shall institute a Speaker Monitoring Program under which GSK compliance or other appropriately trained GSK personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) Personnel shall attend a designated number of speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For The number of programs to be audited shall be determined by OIG after taking into account the first Reporting Period, GSK shall conduct live audits number of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programsconducted by Aegerion. The programs subject to Speaker Program Audits shall be judgmentally selected both on a risk-based targeting approach and on a sampling approachby Monitoring Personnel. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Aegerion sales representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKAegerion’s Policies and Procedures. GSK Aegerion shall maintain the controls around speaker programs programs, as described above, and shall conduct its Speaker Program Audits Audits, as described above above, throughout the term of the CIA.

Speaker Program Activities. a. With regard to speaker programs, GSK ▇▇▇▇▇▇ shall maintain processes implement a process to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that regarding the speaker may only use GSK of Avanir approved materials and requirements that speakers may not directly or indirectly promote the product for off-label uses.) GSK uses.)‌ b. Avanir shall maintain establish a centralized centralized, electronic system through which to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administeredused for legitimate and lawful purposes in accordance with all applicable Federal health care program and FDA requirements. This system The controls shall establish controls regarding eligibility and qualifications of speakers and venues also be designed to ensure that there is a legitimate need for the programs and require speaker programs.‌ c. Avanir shall ensure that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis either conducted by GSK. GSK ▇▇▇▇▇▇ or commissioned by ▇▇▇▇▇▇ using third party consultants with experience conducting fair market value analyses.‌ d. Avanir shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK Avanir shall track use its centralized system to handle all logistics and spending associated with speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK programs.‌ e. Avanir shall require certified evaluations certifications by sales representatives or other Avanir personnel regarding whether that a speaker program complied with GSK with‌ Avanir requirements, and or in the event of non-compliance, GSK Avanir shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK . f. Avanir shall institute a Speaker Monitoring Program under which GSK Avanir compliance or other appropriately trained GSK Avanir personnel who are independent from the functional area being monitored or third party consultants appropriately trained by ▇▇▇▇▇▇ and under the supervision of Avanir (hereinafter “GSK Monitoring Personnel”) shall attend 125 speaker programs relating to Government Reimbursed Products during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on using either a risk-based targeting approach and on or a random sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Avanir sales representative activities during the program to assess whether the programs were conducted in a manner consistent with GSK▇▇▇▇▇▇’s Policies and Procedures. GSK Avanir shall maintain the controls around speaker programs as described above, above and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. a. With regard to speaker programs, GSK USWM shall maintain processes implement a process to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that Corporate Integrity Agreement – USWM regarding the speaker may only use GSK of USWM approved materials and requirements that speakers may not directly or indirectly promote the product for off-label uses.) GSK ) b. USWM shall maintain establish a centralized centralized, electronic system through which to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administeredused for legitimate and lawful purposes in accordance with all applicable Federal health care program and FDA requirements. This system The controls shall establish controls regarding eligibility and qualifications of speakers and venues also be designed to ensure that there is a legitimate need for the programs and require speaker programs.‌ c. USWM shall ensure that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSK. GSK USWM.‌ d. USWM shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK USWM shall track use its centralized system to handle all logistics and spending associated with speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK programs.‌ e. USWM shall require certified evaluations certifications by sales representatives or other USWM personnel regarding whether that a speaker program complied with GSK USWM requirements, and or in the event of non-compliance, GSK USWM shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK violation.‌ f. USWM shall institute a Speaker Monitoring Program under which GSK USWM compliance or other appropriately trained GSK USWM personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend 20 speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on selected‌ Corporate Integrity Agreement – USWM using either a risk-based targeting approach and on or a random sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK USWM sales representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKUSWM’s Policies and Procedures. GSK USWM shall maintain the controls around speaker programs as described above, above and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programs, GSK Baxano Surgical shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK Baxano Surgical approved materials and may not directly or indirectly promote the product for off-label label, investigational, or unapproved uses.) GSK ). Baxano Surgical shall maintain a centralized electronic system through which all speaker programs are administered. This system shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSKBaxano Surgical. GSK Baxano Surgical shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK Baxano Surgical shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK Baxano Surgical shall require certified evaluations the completion of monitoring forms by sales representatives or other Baxano Surgical personnel regarding whether a speaker program complied with GSK Baxano Surgical requirements, and in the event of non-compliance, GSK Baxano Surgical shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK Baxano Surgical shall institute a Speaker Monitoring Program under which GSK Baxano Surgical compliance or other appropriately trained GSK Baxano Surgical personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits at least 10 percent of the such programs (“Speaker Program Audits”). For the first If Baxano Surgical does not conduct any speaker programs during a Reporting Period, GSK shall Baxano Surgical monitoring personnel are not required to conduct live audits of 150 speaker programs and for during that Reporting Period. If Baxano Surgical conducts 10 or fewer speaker programs in a Reporting Period, Baxano Surgical shall audit at least half of the subsequent performed Speaker Programs in that Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approachPeriod. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Baxano Surgical representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKBaxano Surgical’s Policies and Procedures. GSK Baxano Surgical shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programsprograms relating to Government Reimbursed Products, GSK Allergan shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK Allergan approved materials and may not directly or indirectly promote the product for off-label uses.) GSK ). Allergan shall maintain a centralized electronic system (BEACON) through which all such speaker programs are administered. This system BEACON shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, pre-set managed rate structure determined based on a fair-market value analysis conducted by GSKAllergan. GSK Allergan shall continue to maintain a comprehensive list of speaker program attendees through its centralized systemBEACON. In addition, GSK through BEACON, Allergan shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs relating to Government Reimbursed Products conducted during each Reporting Period. GSK Allergan shall require require, through BEACON, certified evaluations by sales representatives or other Allergan personnel regarding whether a speaker program complied with GSK Allergan requirements, and in the event of non-compliance, GSK Allergan shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK Allergan shall institute a Speaker Monitoring Program under which GSK Allergan compliance or other appropriately trained GSK management personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) or outside personnel acting on behalf of Allergan shall attend 75 speaker programs relating to Government Reimbursed Products during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits monitoring of the programs (Speaker Program AuditsMonitoring Program). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to the Speaker Monitoring Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Monitoring Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Allergan representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKAllergan’s Policies and Procedures. GSK Allergan shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Monitoring Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With regard to speaker programs, GSK a. ACell shall maintain processes implement a process to require all speakers for ACell speaker programs to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that regarding the speaker may only use GSK of ACell approved materials and requirements that speakers may not directly or indirectly promote the product for off-label uses.) GSK uses).‌ b. ACell shall maintain establish a centralized centralized, electronic system through which to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administered. This system used for legitimate and lawful purposes in accordance with all‌ applicable Federal health care program and FDA requirements. c. ACell shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require ensure that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSK. GSK or for ACell.‌ d. ACell shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK ACell shall track use its centralized system to handle all logistics and spending associated with speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK programs.‌ e. ACell shall require certified evaluations certifications by sales representatives or other ACell personnel regarding whether that a speaker program complied with GSK ACell requirements, and or in the event of non-compliance, GSK ACell shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK violation.‌ f. ACell shall institute a Speaker Monitoring Program under which GSK ACell compliance or other appropriately trained GSK ACell personnel or appropriately trained contractors engaged by ACell who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) shall attend 15 speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on using either a risk-based targeting approach and on or a random sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK ACell sales representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKACell’s Policies and Procedures. GSK shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.Procedures.‌

Speaker Program Activities. With regard to speaker programs, GSK a. SUN shall maintain processes implement a process to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that regarding the speaker may only use GSK of SUN approved materials and requirements that speakers may not directly or indirectly promote the product for off-label uses.) GSK ). b. SUN shall maintain establish a centralized centralized, electronic system through which to initiate and track all speaker programs that includes controls designed to ensure that speaker programs are administered. This system used for legitimate and lawful purposes in accordance with all applicable Federal health care program and FDA requirements. c. SUN shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require ensure that speakers are paid according to a centrally managed, pre-set rate structure determined based on a fair-market value analysis conducted by GSK. GSK SUN. d. SUN shall maintain a comprehensive list of speaker program attendees through its centralized system. In addition, GSK SUN shall track use its centralized system to handle all logistics and spending associated with speaker programs, including the tracking and review of the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK programs. e. SUN shall require certified evaluations certifications by sales representatives or other SUN personnel regarding whether that a speaker program complied with GSK SUN requirements, and or in the event of non-compliance, GSK SUN shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK . f. SUN shall institute a Speaker Monitoring Program under which GSK SUN compliance or other appropriately trained GSK SUN personnel who are independent from the functional area being SUN Corporate Integrity Agreement monitored (hereinafter “GSK Monitoring Personnel”) shall attend 45 speaker programs during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the programs (Speaker Program Audits). For the first Reporting Period, GSK shall conduct live audits of 150 speaker programs and for the subsequent Reporting Periods, GSK shall conduct live audits of 75 speaker programs. The programs subject to Speaker Program Audits shall be selected both on using either a risk-based targeting approach and on or a random sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits Monitoring Personnel shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK SUN sales representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKSUN’s Policies and Procedures. GSK SUN shall maintain the controls around speaker programs as described above, above and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.

Speaker Program Activities. With To the extent not already required, with regard to speaker programs, GSK Forest shall maintain processes to require all speakers to complete training and enter written agreements that describe the scope of work to be performed, the speaker fees to be paid, and compliance obligations for the speakers (including requirements that the speaker may only use GSK Forest-approved materials and may not directly or indirectly promote the product for off-label uses.) GSK Forest and/or its designee shall maintain a centralized electronic system systems or processes through which all speaker programs are administered. This system These systems or processes shall establish controls regarding eligibility and qualifications of speakers and venues for the programs and require that speakers are paid according to a centrally managed, managed pre-set rate structure determined based on a fair-fair- Corporate Integrity Agreement Forest Laboratories, Inc. market value analysis conducted by GSKForest. GSK Forest shall maintain a comprehensive list of speaker program attendees through its centralized systemsystems and processes. In addition, GSK Forest shall track and review the aggregate amount (including speaker fees, travel, and other expenses) paid to each speaker in connection with speaker programs conducted during each Reporting Period. GSK Forest shall require certified evaluations by sales representatives or other Forest personnel regarding whether a speaker program complied with GSK Forest requirements, and in the event of non-compliance, GSK Forest shall require the identification of the policy violation and ensure appropriate follow up activity to address the violation. To the extent not already accomplished, GSK Forest shall institute a Speaker Monitoring Program under which GSK compliance Forest Compliance or other appropriately trained GSK management personnel, or outside personnel who are independent from the functional area being monitored (hereinafter “GSK Monitoring Personnel”) acting on behalf of Forest, shall attend 175 speaker programs relating to Government Reimbursed Products during each Reporting Period and GlaxoSmithKline LLC Corporate Integrity Agreement conduct live audits of the those programs (Speaker Program Audits). For Sixty percent of the first Reporting Period, GSK programs subject to the Speaker Program Audits shall conduct live audits of 150 speaker be in-office programs and for the subsequent Reporting Periods, GSK forty percent shall conduct live audits of 75 speaker be out-of- office programs. The programs subject to Speaker Program Audits shall be selected both on a risk-based targeting approach and on a sampling approach. For each program reviewed, personnel conducting the Speaker Program Audits shall review slide materials and other materials used as part of the speaker program, speaker statements made during the program, and GSK Forest representative activities during the program to assess whether the programs were conducted in a manner consistent with GSKForest’s Policies and Procedures. GSK Forest shall maintain the controls around speaker programs as described above, and shall conduct its Speaker Program Audits as described above throughout the term of the CIA.