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.)
Appears in 2 contracts
Sources: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)