Common use of Consulting Arrangement Activities Clause in Contracts

Consulting Arrangement Activities. To the extent that Life Spine engages HCPs for consulting services (e.g., training and education services, speaker programs, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, and authorship activities, and any other financial engagement or arrangement with an HCP), such HCPs shall be referred to as Consultants. Within 120 days after the Effective Date, Life Spine shall: a. Require all Consultants to enter written agreements describing the scope of work to be performed, the consultant fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on an independent fair-market value analysis. b. Establish a process to develop an annual budgeting plan that specifies (i) the business needs for, and the estimated numbers of, the various Consultant engagements and activities to occur during the following year and (ii) the budgeted amounts to be spent on Consultant-related activities. Life Spine compliance personnel shall be involved in the review and approval of such plans, including any subsequent modification of an approved plan for the purpose of ensuring that Consultant arrangements and related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Life Spine Policies and Procedures. c. 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 and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and the 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 Life Spine compliance personnel. d. Amend its policies and procedures in a manner designed to ensure that each Consultant performs the work for which the Consultant was engaged and that, as applicable, Life Spine receives the work product generated by the Consultant.

Consulting Arrangement Activities. To the extent that Life Spine RMS engages HCPs for consulting services other than for speaker programs (e.g., training and education services, speaker programs, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, and authorship activities, and any other financial engagement or arrangement with an HCP), such HCPs shall be referred to herein as Consultants. Within 120 90 days after of the Effective Date, Life Spine RMS shall: a. Require all Consultants to enter written agreements describing the scope of work to be performed, the consultant fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on an independent fair-market value analysis. b. Establish a process to develop an annual budgeting plan that specifies (i) the business needs for, and the estimated numbers of, the various Consultant engagements and activities to occur during the following year and (ii) the budgeted amounts to be spent on Consultant-related activities. Life Spine RMS compliance personnel shall be involved in the review and approval of such plans, including any subsequent modification of an approved plan plan, for the purpose of ensuring that Consultant arrangements and related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Life Spine RMS Policies and Procedures. c. 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 and HCIs to be engaged, the agenda for the any proposed meeting, and a description of the proposed work to be done and the 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 Life Spine RMS compliance personnel. d. Amend its policies and procedures in a manner designed to ensure that each Consultant performs the work for which the Consultant was is engaged and that, as applicable, Life Spine RMS receives the work product generated by the Consultant.

Consulting Arrangement Activities. To the extent that Life Spine RMS engages HCPs for consulting services other than for speaker programs (e.g., training and education services, speaker programs, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, and authorship activities, and any other financial engagement or arrangement with an HCP), such HCPs shall be referred to herein as Consultants. Within 120 90 days after of the Effective Date, Life Spine shall:RMS shall:‌ a. Require all Consultants to enter written agreements describing the scope of work to be performed, the consultant fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on an independent fair-market value analysis.analysis.‌ b. Establish a process to develop an annual budgeting plan that specifies (i) the business needs for, and the estimated numbers of, the various Consultant engagements and activities to occur during the following year and (ii) the budgeted amounts to be spent on Consultant-related activities. Life Spine RMS compliance personnel shall be involved in the review and approval of such plans, including any subsequent modification of an approved plan plan, for the purpose of ensuring that Consultant arrangements and related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Life Spine RMS Policies and Procedures.Procedures.‌ c. 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 and HCIs to be engaged, the agenda for the any proposed meeting, and a description of the proposed work to be done and the type of work product to be generated). Any deviations from the Consultant budgeting plans shall be be‌‌ documented in the needs assessment form and shall be subject to review and approval by Life Spine RMS compliance personnel.personnel.‌ d. Amend its policies and procedures in a manner designed to ensure that each Consultant performs the work for which the Consultant was is engaged and that, as applicable, Life Spine XXX receives the work product generated by the Consultant.

Consulting Arrangement Activities. To the extent that Life Spine Merit engages HCPs for consulting services other than for speaker programs (e.g., training and education services, speaker programs, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, and authorship activities, and any other financial engagement or arrangement with an HCP), such HCPs shall be referred to herein as Consultants. Within 120 days after of the Effective Datedate, Life Spine Merit shall: a. Require all Consultants to enter written agreements describing the scope of work to be performed, the consultant fees to be paid, and compliance obligations for the Consultants. Consultants shall be paid according to a centrally managed, pre-set rate structure that is determined based on an independent fair-market value analysis. b. Establish a process to develop an annual budgeting plan that specifies (i) the business needs for, and the estimated numbers of, the various Consultant engagements and activities to occur during the following year and (ii) the ii)the budgeted amounts to be spent on Consultant-related activities. Life Spine Merit compliance personnel shall be involved in the review and approval of such plans, including any subsequent modification of an approved plan for the purpose of ensuring that Consultant arrangements and related events are used for legitimate and lawful purposes in accordance with applicable Federal health care program and FDA requirements and Life Spine Merit Policies and Procedures. c. 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 and HCIs to be engaged, the agenda for the proposed meeting, and a description of the proposed work to be done and the 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 Life Spine Merit compliance personnel. d. Amend its policies and procedures in a manner designed to ensure that each Consultant performs the work for which the Consultant was is engaged and that, as applicable, Life Spine Merit receives the work product generated by the Consultant.