Consultant Arrangement Activities. To the extent that GSK engages U.S.-based HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. GSK shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair- market value analysis conducted by GSK. To the extent not already accomplished, within 120 days after the Effective Date, GSK shall establish a process to develop annual budgeting plans that identify the business needs for, and the estimated numbers of, various Consultant engagements and activities to occur during the following year. The annual Consultant budgeting plans shall also identify the budgeted amounts to be spent on Consultant-related activities. GSK’s Monitoring Personnel shall be involved in the review and approval of such budgeting plans, including any subsequent modification of an approved plan. The purpose of this review shall be to ensure that Consultant arrangements and related events are used for legitimate purposes in accordance with applicable GSK Policies and Procedures. GlaxoSmithKline LLC Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, GSK shall establish a process to ensure that a needs assessment has been completed to justify the retention of a Consultant prior to the retention of the Consultant. The needs assessment shall identify the business need for the retention of the Consultant and provide specific details about the consulting arrangement (e.g., information about the numbers and qualifications of the HCPs or HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and type of work product to be generated.) Any deviations from the Consultant budgeting plans shall be documented in the needs assessment form and shall be subject to review and approval by GSK Monitoring Personnel. To the extent not already accomplished, within 120 days after the Effective Date, GSK shall amend its policies and procedures in a manner designed to ensure that each Consultant performed the wor...
Consultant Arrangement Activities. To the extent that the J&J Pharmaceutical Affiliates engage Consultants during the term of the CIA, the J&J Pharmaceutical Affiliates created, and shall maintain throughout the term of this CIA, monitoring assessments that evaluate compliance with the Consultant Arrangements Controls consistent with the J&J Pharmaceutical Affiliates’ Policies and Procedures. Monitoring Personnel shall review, and complete monitoring assessments for, at least 50 Consultant arrangements with HCPs or HCIs in the period January 1, 2013 to December 31, 2013 and the Second Reporting period (January 1, 2014 to December 31, 2014). Beginning January 1, 2015, and for each subsequent calendar year in the remainder of the term of the CIA, Monitoring Personnel shall review, and complete monitoring assessments for, at least the number of Consultant arrangements with HCPs or HCIs selected in accordance with the applicable year’s Monitoring Plan and as approved by OIG in accordance with Section III.L.2.a.
Consultant Arrangement Activities. To the extent that Amgen engages Consultants during the term of the CIA, Amgen created, and shall maintain throughout the term of this CIA, Monitoring Worksheets that assess compliance with the Corporate Integrity Agreement Amgen Inc. Consultant Arrangements Controls consistent with Amgen’s Policies and Procedures. In the period January 1, 2013 to December 31, 2013, Monitoring Personnel shall review, and complete Monitoring Worksheets for, at least 75 Consultant arrangements with HCPs or HCIs. Beginning January 1, 2014, and for each subsequent calendar year in the remainder of the term of the CIA, Monitoring Personnel shall review, and complete Monitoring Worksheets for, at least the number of Consultant arrangements with HCPs or HCIs selected in accordance with the applicable year’s Monitoring Plan and as approved by the OIG in accordance with Section III.K.2.a.
Consultant Arrangement Activities. To the extent that Novartis engages U.S.- based HCPs or HCIs for services that relate to Promotional Functions or to Product Related Functions as defined in Sections II.C.4 and II.C.5 of this Agreement other than for speaker programs, research-related activities, or publication activities (e.g., as a member of an advisory board or to attend consultant meetings), such HCPs or HCIs shall be referred to herein as Consultants. Novartis shall require all Consultants to enter written agreements describing the scope of work to be performed, the fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid based on a fair- market value analysis conducted by Novartis. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement Prior to the Effective Date, Novartis established the EOC process through which individuals (e.g., sales representatives or managers) who propose that Novartis fund a particular consulting arrangement event are required to seek and obtain approval for the event from the EOC, or, in some limited instances, a subgroup of the EOC. At a minimum, the EOC review process shall continue to include evaluation of the following for each proposed consultant arrangement: i) the business purpose/necessity of the engagement including the broader context of other approved events (i.e., a needs assessment); ii) the general qualifications and experience of the consultant to provide the service; iii) the number of consultants necessary for the event; iv) venue/location (as applicable); v) payment and anticipated expenses; and vi) compliance with other applicable legal standards. Representatives from Ethics and Compliance chair the EOC, and other members of the EOC include representatives from Legal, Regulatory, Medical, and other disciplines as appropriate. A proposed consultant arrangement must be approved in accordance with EOC policy before a consultant event may occur. The EOC, as a condition of approval, may require that certain changes be made to a planned event. The person responsible for the consulting arrangement and his/her manager must certify to compliance with all applicable compliance standards and execution of the event consistent with EOC direction and approval. Violations of the policy (including failure to implement an event in compliance with the direction provided by the engagement reviewer(s)) are referred for further investigation in accordance with Novartis policy and may result in disciplinary action, ...
