Common use of Publication Activities Clause in Contracts

Publication Activities. To the extent that Novartis 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. Novartis 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. 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 Novartis. To the extent not already accomplished, within 120 days after the Effective Date, Novartis 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. Novartis’ 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 Novartis Policies and Procedures. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, Novartis shall establish a needs assessment process for Publication Activities. This process shall ensure that a needs assessment has been completed prior to contracting with an Author for a Publication Activity. The needs assessment shall provide 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Novartis compliance personnel. Within 120 days after the Effective Date, Novartis shall establish a Publication Monitoring Program through which it shall conduct audits for each Reporting Period of at least 25 Publication Activities. The Publication Monitoring Program shall select publications for review both on a risk-based targeting approach and on a sampling approach. 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 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 Novartis 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. Novartis Forest shall require all Authors to enter written agreements describing the scope of work to be performed, the 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, pre-set managed rate structure that which incorporates appropriate objective criteria and is determined based on a fair-market value analysis conducted by NovartisForest. To the extent not already accomplished, within 120 days after the Effective Date, Novartis Forest shall establish a process to develop annual plans that identify the business needs for and the estimated numbers of various Publication Activities (Publications Publication Plans). The annual Publications Publication Plan shall also identify the budgeted amounts to be spent on Publication Activities. Novartis’ compliance Forest’s Compliance personnel shall be involved in the review and approval of such annual Publications 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 Novartis Forest Policies and Procedures. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, Novartis Forest shall establish a needs assessment process for Publication Activities. This process shall ensure that a needs assessment has been completed prior to contracting with the retention of an Author for a Publication Activity. The needs assessment shall provide information 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 Publications Publication Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Novartis compliance Forest Compliance personnel. Within 120 days after the Effective Date, Novartis Forest shall establish a Publication Monitoring Program through which it shall conduct audits for each Reporting Period of at least 25 30 Publication Activities. The Publication Monitoring Program shall select publications for review both on a risk-based targeting approach and on a sampling approach. Novartis compliance personnel 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 Novartis’ 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 Novartis Compliance Department for review and follow-up as appropriate.

Publication Activities. To the extent that Novartis 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. Novartis BIPI 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. 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 NovartisBIPI. To the extent not already accomplished, within 120 days after the Effective Date, Novartis BIPI 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. Novartis’ BIPI’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 Novartis BIPI Policies and Procedures. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement To the extent not already accomplished, within 120 days after the Effective Date, Novartis BIPI shall establish a needs assessment process for Publication Activities. This process shall ensure that a needs assessment has been completed prior to contracting with the retention of an Author for a Publication Activity. The needs assessment shall provide information 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Novartis BIPI compliance personnel. Within 120 days after the Effective Date, Novartis BIPI shall establish a Publication Monitoring Program through which it shall conduct audits for each Reporting Period of at least 25 30 Publication Activities. The Publication Monitoring Program shall select publications for review both on a risk-based targeting approach and on a sampling approach. Novartis compliance personnel 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 Novartis’ BIPI’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 Novartis Ethics and Compliance Department for review and follow-up as appropriate.

Publication Activities. To the extent that Novartis 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. Novartis Allergan 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. 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 NovartisAllergan. 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, Novartis Allergan 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. Novartis’ compliance personnel Allergan’s Medical Affairs personnel, in consultation with the Corporate Compliance Department 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 Novartis Allergan Policies and Procedures. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement To the extent not already accomplished, within 120 150 days after the Effective Date, Novartis Allergan shall establish a needs assessment process for Publication Activities. This process shall ensure that a needs assessment has been completed prior to contracting with the retention of an Author for a Publication Activity. The needs assessment shall provide information 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Novartis compliance personnel). Within 120 150 days after the Effective Date, Novartis Allergan shall establish a Publication Monitoring Program through which it shall conduct audits monitoring for each Reporting Period of at least 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. Novartis 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 Novartis’ Allergan’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 Novartis Corporate Compliance Department for review and follow-up as appropriate.

Publication Activities. To the extent that Novartis 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. Novartis 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 NovartisEndo. To the extent not already accomplished, within Within 120 days after the Effective Date, Novartis Endo 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 Plans shall also identify the budgeted amounts to be spent on Publication Activities. Novartis’ Endo's compliance and/or legal 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 This review process shall be designed to ensure that Publication Activities and related events are used for Endo Pharmaceuticals Inc. Corporate Integrity Agreement legitimate purposes in accordance with Novartis Endo Policies and ProceduresProcedures and with applicable Federal health care program and FDA requirements. Novartis Pharmaceuticals Corporation Corporate Integrity Agreement To the extent not already accomplished, within Within 120 days after the Effective Date, Novartis Endo shall establish a needs assessment process for Publication Activities. This process shall be designed to ensure that a needs assessment has been completed prior to contracting with the retention of an Author for to undertake a Publication Activity. The needs assessment shall provide information 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by Novartis Endo compliance and/or legal personnel. Within 120 days after the Effective Date, Novartis Endo shall establish a Publication Monitoring Program through which it shall conduct audits for each Reporting Period of at least 25 10 Publication Activities. The Publication Monitoring Program shall select publications for review both on a risk-based targeting approach and on a sampling approach. Novartis compliance personnel conducting the Publication Endo Monitoring Program 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 Activities), in order to assess whether the activities were conducted in a manner consistent with Novartis’ Endo'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 Novartis Compliance Department Officer (or designee) for review and follow-up up, as appropriate.