Publication Activities. GSK represents that it generally does not engage HCPs or HCIs exclusively to produce articles or other publications relating to GSK-Sponsored Research, and that generally HCPs or HCIs who perform this work do so as part of an engagement for Research Related Activities. To the extent that, in connection with Research Related Activities, U.S.-based HCPs or HCIs produce articles or other publications relating to GSK-Sponsored Research (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors. GSK shall require all Authors to enter written agreements describing the terms of the arrangement between GSK and the Author and compliance obligations of the Authors. Authors shall be paid according to the centrally managed, pre-set rate structure that is established for Research Related Activities but will not be paid separately for authorship or other publication-specific activity (provided that GSK may reimburse travel expenses incurred to make public presentations of data from GSK-Sponsored Research Studies). If, in a departure from usual practice, GSK engages an HCP or HCI for a stand-alone project involving the production of an article or other publication relating to GSK-Sponsored Research (e.g., a review article summarizing research in a field that includes GSK-Sponsored Research), GSK will require a written agreement with the same compliance obligations as it requires of Author generally and will pay for the work according to the centrally managed, pre-set rate structure as applied to Consultants generally. To the extent not already accomplished, within 120 days after the Effective Date, GSK shall establish a process to develop annual plans that identify the business needs for and the estimated numbers of various Publication Activities (Publications Plans). The annual Publications Plan shall also identify the budgeted amounts to be spent on Publication Activities. GSK’s U.S. compliance personnel shall be involved in the review and approval of such annual Publications Plans, including any modification of an approved plan. The purpose of this review shall be to ensure that Publication Activities 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 needs assessment process for Publication Activities. This process GlaxoSmithKline LLC Corporate Integrity Agreement shall ensure that a ne...
Publication Activities. To the extent that Forest engages U.S.-based HCPs or HCIs to produce articles or other publications relating to Government Reimbursed Products (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors. Forest shall require all Authors to enter written agreements describing the scope of work to be performed, any fees to be paid in connection with the Publication Activities, and compliance obligations of the Authors. Authors shall be paid according to a centrally managed rate structure which incorporates appropriate objective criteria and is determined based on a fair-market value analysis conducted by Forest. To the extent not already accomplished, within 120 days after the Effective Date, Forest shall establish a process to develop annual plans that identify the business needs for and the estimated numbers of various Publication Activities (Publication Plans). The Corporate Integrity Agreement Forest Laboratories, Inc. annual Publication Plan shall also identify the budgeted amounts to be spent on Publication Activities. Forest’s Compliance personnel shall be involved in the review and approval of such annual Publication Plans, including any modification of an approved plan. The purpose of this review shall be to ensure that Publication Activities and related events are used for legitimate purposes in accordance with Forest Policies and Procedures. To the extent not already accomplished, within 120 days after the Effective Date, Forest shall establish a needs assessment process for Publication Activities. This process shall ensure that a needs assessment has been completed prior to the retention of an Author for a Publication Activity. The needs assessment shall provide specific details about Publication Activities to be performed (including a description of the proposed work to be done, type of work product to be generated, and the purpose for the work.) Any deviations from the Publication Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Forest Compliance personnel. Within 120 days after the Effective Date, Forest shall establish a Publication Monitoring Program through which it shall conduct audits for each Reporting Period of at least 30 Publication Activities. The Publication Monitoring Program shall select publications for review both on a risk-based targeting approach and on a sampling approach. Personnel conducting the Publication Monit...
Publication Activities. To the extent that Indivior engages HCPs or HCIs to produce articles or other publications relating to Government Reimbursed Products (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors.
Publication Activities. The Publication Monitoring Program shall select Publication Activities for review both on either a risk-based targeting approach or a random sampling approach. Monitoring Personnel shall review needs assessment documents, proposal documents, approval documents, contracts, payments and materials relating to the Publication Activities (including work product resulting from the Publication Activities), in order to assess whether the Publication Activities were conducted in a manner consistent with Indivior’s Policies and Procedures. Results from the Publication Monitoring Program, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Officer (or compliance personnel designee) for review and follow-up as appropriate.
Publication Activities. To the extent that Indivior engages HCPs or HCIs to produce articles or other publications relating to Government Reimbursed Products (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors.
(a) Indivior shall require all Authors to enter written agreements describing the scope of work to be performed, the fees to be paid in connection with the Publication Activities, and compliance obligations of the Authors, including the requirement that Authors disclose the financial and other current relationships with Indivior. Authors shall be paid according to a centrally managed, pre-set rate structure that is determined based on a third-party fair-market value analysis.
(b) Within 90 days after the Effective Date, Indivior shall establish a process to develop annual plans that identify the business needs for and the estimated number of Publication Activities (Publication Plan). The annual Publication Plan shall also identify the budgeted amounts to be spent on Publication Activities. Indivior’s compliance personnel shall be involved in the review and approval of each annual Publication Plan, including any modification of an approved plan. The purpose of this review shall be to ensure that Publication Activities are used for legitimate purposes in accordance with Indivior Policies and Procedures and with Federal health care program and FDA requirements.
(c) Within 90 days after the Effective Date, Indivior shall establish a needs assessment process for Publication Activities. This process shall ensure that a needs assessment has been completed prior to the retention of an Author to undertake a Publication Activity. The needs assessment shall provide specific details about Publication Activities to be performed (including a description of the proposed work to be done, type of work product to be generated, and the purpose for the work.)
Publication Activities. The Contractor shall refer all publications arising as a direct result of this Contract to the Client, at least 20 (twenty) calendar days before the publication is submitted to scientific journal, proceedings or other periodicals. Where both Client and Contractor agree, comments or amendments suggested by the Client will be added to the text of publication. The Contractor shall acknowledge in the publications the present Framework Contract and the ELI-Beamlines Project as the source of funding supporting the work reported, in the Acknowledgments section of the publication. The Contractor undertakes to observe any applicable regulations governing publicity arising from the binding documentations under OP RDI.
Publication Activities. Each of the Contractual Parties shall be entitled to publish the results of its work under this Contract only after a prior consent in writing from the other Contractual Party. The Contractual Parties shall always acknowledge in the publications the present Contract and the XXX-Beamlines Project as the source of funding supporting the work reported, in the Acknowledgments section of the publication.
Publication Activities. To the extent that Par engages U.S.-based HCPs or HCIs to produce articles or other publications relating to Relevant Government Reimbursed Products (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors. Par shall require all Authors to enter written agreements describing the terms of the arrangement between Xxx and the Author and compliance obligations of the Authors. Authors shall be paid according to the centrally managed, pre-set rate structure that is established for Research related activities. If Par engages in Publication Activities, Par shall determine whether there is a business need for the publication(s) prior to retaining the author. If Par engages in Publication Activities, Par shall establish a plan for publications for the year, which shall include a budget for publications.
Publication Activities. To the extent that Endo engages HCPs or HCIs to produce articles or other publications relating to Government Reimbursed Products (collectively "Publication Activities") such HCPs or HCIs shall be referred to as Authors. Endo shall require all Authors to enter into written agreements describing the scope of work to be performed, the fees to be paid in connection with the Publication Activities, and compliance obligations of the Authors. Authors shall be paid according to a centrally managed, pre-set rate structure that is determined based on a fair-market value analysis conducted by Endo.
Publication Activities. To the extent that Amgen engages Authors for Publication activities, Amgen created, and shall continue to maintain throughout the term of this CIA, Monitoring Worksheets that assess compliance with the Publication Controls consistent with Amgen’s Policies and Procedures. In the period January 1, 2013 through December 31, 2013, Monitoring Personnel shall review, and complete Monitoring Worksheets for, at least 25 Publication activities. 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 Publication activities selected in accordance with the applicable Monitoring Plan and as approved by OIG in accordance with Section III.K.2.a.
