Common use of Publication Activities Clause in Contracts

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 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by GSK Monitoring Personnel.

Publication Activities. GSK represents To the extent that it generally does not engage AstraZeneca engages 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 Government Reimbursed Products (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors. GSK AstraZeneca shall require all Authors to enter written agreements describing the terms scope of work to be performed, the arrangement between GSK and fees to be paid in connection with the Author Publication Activities, and compliance obligations of the Authors. Authors shall be paid according to the a centrally managed, pre-set rate structure that is established for Research Related Activities but will not be paid separately for authorship or other publicationdetermined based on a fair-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 generallymarket value analysis conducted by AstraZeneca. To the extent not already accomplished, within 120 days after the Effective Date, GSK AstraZeneca 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. GSKAstraZeneca’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 AstraZeneca Policies and Procedures. To the extent not already accomplished, within 120 days after the Effective Date, GSK AstraZeneca shall establish a needs assessment process for Publication Activities. This process GlaxoSmithKline LLC Corporate Integrity Agreement 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 Publications Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by GSK AstraZeneca U.S. compliance personnel. Corporate Integrity Agreement AstraZeneca Within 120 days after the Effective Date, AstraZeneca shall establish a Publication Monitoring PersonnelProgram through which it shall conduct audits for each Reporting Period of at least 50 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. AstraZeneca U.S. 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 AstraZeneca’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 U.S. Compliance Department for review and follow-up as appropriate.

Publication Activities. GSK represents To the extent that it generally does not engage Forest engages U.S.-based 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 Government Reimbursed Products (collectively “Publication Activities”) such HCPs or HCIs shall be referred to as Authors. GSK Forest shall require all Authors to enter written agreements describing the terms scope of work to be performed, any fees to be paid in connection with the arrangement between GSK and the Author Publication Activities, and compliance obligations of the Authors. Authors shall be paid according to the a centrally managed, pre-set managed rate structure that which incorporates appropriate objective criteria and is established for Research Related Activities but will not be paid separately for authorship or other publicationdetermined based on a fair-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 generallymarket value analysis conducted by Forest. To the extent not already accomplished, within 120 days after the Effective Date, GSK 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 Corporate Integrity Agreement Forest Laboratories, Inc. annual Publications Publication Plan shall also identify the budgeted amounts to be spent on Publication Activities. GSKForest’s U.S. compliance 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 GSK Forest Policies and Procedures. To the extent not already accomplished, within 120 days after the Effective Date, GSK Forest shall establish a needs assessment process for Publication Activities. This process GlaxoSmithKline LLC Corporate Integrity Agreement 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 Publications Publication Plan shall be documented in the needs assessment form (or elsewhere, as appropriate) and shall be subject to review and approval by GSK Forest Compliance personnel. Within 120 days after the Effective Date, Forest shall establish a Publication Monitoring PersonnelProgram 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.