Common use of Publication Activities Clause in Contracts

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 Monitoring Program shall review needs assessment documents, proposal documents, approval documents, contracts, payments and materials relating to the Publication Activities (including work product resulting from the Activities), in order to assess whether the activities were conducted in a manner consistent with Forest’s Policies and Procedures. Results from the Publication Monitoring Programs, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Publication Activities. To the extent that Forest Novartis 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 Novartis shall require all Authors to enter written agreements describing the scope of work to be performed, any 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 managed, pre-set rate structure which incorporates appropriate objective criteria and that is determined based on a fair-market value analysis conducted by ForestNovartis. To the extent not already accomplished, within 120 days after the Effective Date, Forest Novartis shall establish a process to develop annual plans that identify the business needs for and the estimated numbers of various Publication Activities (Publication Publications Plans). The Corporate Integrity Agreement Forest Laboratories, Inc. annual Publication Publications Plan shall also identify the budgeted amounts to be spent on Publication Activities. Forest’s Compliance Novartis’ compliance personnel shall be involved in the review and approval of such annual Publication 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 Forest Novartis Policies and Procedures. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, Forest Novartis 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 contracting with an Author for a Publication Activity. The needs assessment shall provide specific details information 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Forest Compliance Novartis compliance personnel. Within 120 days after the Effective Date, Forest Novartis shall establish a Publication Monitoring Program through which it shall conduct audits for each Reporting Period of at least 30 25 Publication Activities. The Publication Monitoring Program shall select publications for review both on a risk-based targeting approach and on a sampling approach. Personnel Novartis compliance personnel conducting the Publication Monitoring Program shall review needs assessment documents, proposal documents, approval documents, contracts, payments and materials relating to the Publication Activities (including work product resulting from the Activities), in order to assess whether the activities were conducted in a manner consistent with Forest’s Novartis’ Policies and Procedures. Results from the Publication Monitoring Programs, including the identification of potential violations of policies, shall be compiled and reported to the Novartis Compliance Department for review and follow-up as appropriate.

Publication Activities. To the extent that Forest BIPI 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 BIPI shall require all Authors to enter written agreements describing the scope of work to be performed, any 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 managed, pre-set rate structure which incorporates appropriate objective criteria and that is determined based on a fair-market value analysis conducted by ForestBIPI. To the extent not already accomplished, within 120 days after the Effective Date, Forest BIPI shall establish a process to develop annual plans that identify the business needs for and the estimated numbers of various Publication Activities (Publication Publications Plans). The Corporate Integrity Agreement Forest Laboratories, Inc. annual Publication Publications Plan shall also identify the budgeted amounts to be spent on Publication Activities. ForestBIPI’s Compliance compliance personnel shall be involved in the review and approval of such annual Publication 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 Forest BIPI Policies and Procedures. To the extent not already accomplished, within 120 days after the Effective Date, Forest BIPI 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Forest Compliance BIPI compliance personnel. Within 120 days after the Effective Date, Forest BIPI 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. Monitoring Personnel conducting the Publication Monitoring Program shall review needs assessment documents, proposal documents, approval documents, contracts, payments and materials relating to the Publication Activities (including work product resulting from the Activities), in order to assess whether the activities were conducted in a manner consistent with ForestBIPI’s Policies and Procedures. Results from the Publication Monitoring Programs, including the identification of potential violations of policies, shall be compiled and reported to the Ethics and Compliance Department for review and follow-up as appropriate.

Publication Activities. To the extent that Forest Allergan engages U.S.-based HCPs or HCIs to produce articles or other publications relating to Phase IV post-marketing studies or IITs relating to Government Reimbursed Products (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors. Forest Allergan shall require all Authors to enter written agreements describing the scope of work to be performed, any 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 rate structure which incorporates appropriate objective criteria and is determined based on a fair-market value analysis conducted by ForestAllergan. This fair-market value analysis shall be incorporated into guidelines that are used in the review, approval, and funding of Publication Activities. Documentation of such review, approval, and funding activities shall be maintained by Allergan Medical Affairs. To the extent not already accomplished, within 120 150 days after the Effective Date, Forest Allergan shall establish a process to develop annual plans that identify the business needs for and the estimated numbers of various Publication Activities (Publication Publications Plans). The Corporate Integrity Agreement Forest Laboratories, Inc. annual Publication Publications Plan shall also identify the budgeted amounts to be spent on Publication Activities. ForestAllergan’s Medical Affairs personnel, in consultation with the Corporate Compliance personnel Department personnel, shall be involved in the review and approval of such annual Publication 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 Forest Allergan Policies and Procedures. To the extent not already accomplished, within 120 150 days after the Effective Date, Forest Allergan 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 120 150 days after the Effective Date, Forest Allergan shall establish a Publication Monitoring Program through which it shall conduct audits monitoring for each Reporting Period of at least 30 25 U.S.-sponsored Publication Activities. The Publication Monitoring Program shall select publications for review both on a risk-based targeting approach and on a sampling approach. Personnel Allergan compliance personnel conducting the Publication Monitoring Program shall review needs assessment documents, proposal documents, approval documents, contracts, payments and materials relating to the Publication Activities (including work product resulting from the Activities), in order to assess whether the activities were conducted in a manner consistent with ForestAllergan’s Policies and Procedures. Results from the Publication Monitoring Programs, including the identification of potential violations of policies, shall be compiled and reported to the Corporate Compliance Department for review and follow-up as appropriate.

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 Monitoring Program shall review needs assessment documents, proposal documents, approval documents, contracts, payments and materials relating to the Publication Activities (including work product resulting from the Activities), in order to assess whether the activities were conducted in a manner consistent with Forest’s Policies and Procedures. Results from the Publication Monitoring Programs, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Department for review and follow-up as appropriate.

Publication Activities. To the extent that Forest Insys 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 . a. Insys shall require all Authors to enter written agreements describing the scope of work to be performed, any 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 managed, pre-set rate structure which incorporates appropriate objective criteria and that is determined based on a fair-market value analysis conducted by Forest. To the extent not already accomplished, within Insys.‌ b. Within 120 days after the Effective Date, Forest Insys shall establish a process to develop annual plans that identify the business needs for and the estimated numbers number 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. ForestInsys’s Compliance 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 Insys Policies and‌ Procedures and Procedures. To the extent not already accomplished, within with Federal health care program and FDA requirements. c. Within 120 days after the Effective Date, Forest Insys 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 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.) Any deviations from the Publication Publications 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. Insys compliance personnel.‌ d. Within 120 days after the Effective Date, Forest Insys shall establish a Publication Monitoring Program through which it shall conduct audits for each Reporting Period of Publication Activities associated with at least 30 Publication Activitiestwo manuscripts and two abstracts/posters. The Publication Monitoring Program shall select publications for review both on either a risk-based targeting approach and on or a random sampling approach. Monitoring Personnel conducting the Publication Monitoring Program shall review needs assessment documents, proposal documents, approval documents, contracts, payments and materials relating to the Publication Activities (including work product resulting from the Activities), in order to assess whether the activities were conducted in a manner consistent with ForestInsys’s Policies and Procedures. Results from the Publication Monitoring Programs, including the identification of potential violations of policies, shall be compiled and reported to the Compliance Department Officer (or compliance personnel designee) for review and follow-up as appropriate.appropriate.‌