Common use of Budgeting Process Clause in Contracts

Budgeting Process. Astellas’ Independent Charity Group shall establish a budget process to be followed for Astellas’ donations to Independent Charity PAPs that meets the following requirements: a. The Independent Charity Group shall develop an annual budget for donations to Independent Charity PAPs based on objective criteria in accordance with general guidelines approved by the legal department with input from the compliance department.‌ b. Astellas shall approve the annual budget for donations to Independent Charity PAPs at a level within the organization above the commercial organization (e.g., at the executive level).‌‌ c. The Independent Charity Group shall have sole responsibility for allocating the approved budget across donations to Independent Charity PAPs and to any disease state fund established by the Independent Charity PAP.‌ d. The Independent Charity Group shall have sole responsibility for assessing requests for additional or supplemental funding from Independent Charity PAPs outside of the annual budget using standardized, objective criteria established by the‌ Independent Charity Group. Any such requests also shall be subject to legal and compliance personnel review and approval, to ensure that any supplemental funding to the Independent Charity PAP is provided in accordance with applicable Federal health care program requirements, OIG guidance, and Astellas Policies and Procedures. Nothing in this provision limits the ability of the U.S. Compliance Committee Advisory Committee members to review, approve, and adjust the Independent Charity Group’s request for an amendment to the annual budget. e. The commercial organization shall have no involvement in the budget process, and the budget to be used for donations to Independent Charity PAPs shall not be based on monies allocated to the Independent Charity Group from the commercial organization.

Budgeting Process. Astellas’ Independent Charity Group Amgen’s PAP Governance Committee shall establish a budget process to be followed for Astellas’ ▇▇▇▇▇’s donations to Independent Charity PAPs that meets the following requirements: a. The Independent Charity Group PAP Governance Committee shall develop an annual budget for donations to Independent Charity PAPs based on objective criteria in accordance with general guidelines approved by the legal department with input from the compliance department.‌department. b. Astellas Amgen shall approve the annual budget for donations to Independent Charity PAPs at through a level within the process or organization above that does not include, nor is influenced by, the commercial organization (e.g., at the executive level).‌‌Amgen Finance Department).‌‌ c. The Independent Charity Group PAP Governance Committee shall have sole responsibility for allocating the approved budget across donations to Independent Charity PAPs and to any disease state fund established by the Independent Charity PAP.‌ d. The Independent Charity Group PAP Governance Committee shall have sole responsibility for assessing requests for additional or supplemental funding from Independent Charity PAPs outside of the annual budget using standardized, objective criteria established by the‌ Independent Charity Groupthe PAP Governance Committee. Any such requests also shall be subject to legal and compliance personnel review and approval, to ensure that any supplemental funding to the Independent Charity PAP is provided in accordance with applicable Federal health care program requirements, OIG guidance, and Astellas Amgen Policies and Procedures. Nothing in this provision limits the ability of the U.S. Compliance Committee Advisory Committee members to review, approve, and adjust the Independent Charity Group’s request for an amendment to the annual budget.Procedures.‌ e. The commercial organization shall have no involvement in the budget process, and the budget to be used for donations to Independent Charity PAPs shall not be based on monies allocated to the Independent Charity Group PAP Governance Committee from the commercial organization.organization.‌

Budgeting Process. AstellasNovartis’ Independent Charity Group ICCF Executive Committee shall establish a budget process to be followed for AstellasNovartis’ donations to Independent Charity PAPs that meets the following requirements: a. The Independent Charity Group ICCF Executive Committee shall develop an annual budget for donations to Independent Charity PAPs based on objective criteria in accordance with general guidelines approved by the legal department with input from the compliance department.‌department. b. Astellas Novartis shall approve the annual budget for donations to Independent Charity PAPs at a level within the organization above the commercial organization (e.g., at the executive level).‌‌level). c. The Independent Charity Group ICCF Executive Committee shall have sole responsibility for allocating the approved budget across donations to Independent Charity PAPs and to any disease state fund established by the Independent Charity PAP.‌PAP. d. The Independent Charity Group ICCF Executive Committee shall have sole responsibility for assessing requests for additional or supplemental funding from Independent Charity PAPs outside of the annual budget using standardized, objective criteria established by the‌ Independent Charity Groupthe ICCF Executive Committee. Any such requests also shall be subject to legal and compliance personnel review and approval, to ensure that any supplemental funding to the Independent Charity PAP is provided in accordance with applicable Federal health care program requirements, OIG guidance, and Astellas Novartis Policies and Procedures. Nothing in this provision limits the ability of the U.S. Compliance Committee Advisory Committee members to review, approve, and adjust the Independent Charity Group’s request for an amendment to the annual budget. e. The commercial organization shall have no involvement in the budget process, and the budget to be used for donations to Independent Charity PAPs shall not be based on monies allocated to the Independent Charity Group ICCF Executive Committee from the commercial organization.

Budgeting Process. Astellas’ Insys’s Independent Charity Group shall establish a budget process to be followed for Astellas’ ▇▇▇▇▇’s donations to Independent Charity PAPs that meets the following requirements: a. The Independent Charity Group shall develop an annual budget for donations to Independent Charity PAPs based on objective criteria in accordance with general guidelines approved by the legal department with input from the compliance department.‌ b. Astellas Insys shall approve the annual budget for donations to Independent Charity PAPs at a level within the organization above the commercial organization (e.g., at the executive level).‌‌ c. The Independent Charity Group shall have sole responsibility for allocating the approved budget across donations to Independent Charity PAPs and to any disease state fund established by the Independent Charity PAP.‌ d. The Independent Charity Group shall have sole responsibility for assessing requests for additional or supplemental funding from Independent Charity PAPs outside of the annual budget using standardized, objective criteria established by the‌ the Independent Charity Group. Any such requests also shall be subject to legal and compliance personnel review and approval, to ensure that any supplemental funding to the Independent Charity PAP is provided in accordance with applicable Federal health care program requirements, OIG guidance, and Astellas Insys Policies and Procedures. Nothing in this provision limits the ability of the U.S. Compliance Committee Advisory Committee members to review, approve, and adjust the Independent Charity Group’s request for an amendment to the annual budget.Procedures.‌ e. The commercial organization shall have no involvement in the budget process, and the budget to be used for donations to Independent Charity PAPs shall not be based on monies allocated to the Independent Charity Group from the commercial organization.organization.‌