Common use of Budgeting Process Clause in Contracts

Budgeting Process. Amgen’s PAP Governance Committee shall establish a budget process to be followed for ▇▇▇▇▇’s donations to Independent Charity PAPs that meets the following requirements: a. The 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. b. Amgen shall approve the annual budget for donations to Independent Charity PAPs through a process or organization that does not include, nor is influenced by, the commercial organization (e.g., the Amgen Finance Department).‌‌ c. The 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 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 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 Amgen Policies and 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 PAP Governance Committee from the commercial organization.‌

Budgeting Process. Amgen’s PAP Governance Committee Astellas’ Independent Charity Group shall establish a budget process to be followed for ▇▇▇▇▇’s Astellas’ donations to Independent Charity PAPs that meets the following requirements: a. The PAP Governance Committee 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.department.‌ b. Amgen Astellas shall approve the annual budget for donations to Independent Charity PAPs through at a process or level within the organization that does not include, nor is influenced by, above the commercial organization (e.g., at the Amgen Finance Department).‌‌executive level).‌‌ c. The PAP Governance Committee 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 PAP Governance Committee 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 PAP Governance Committeethe‌ 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 Amgen Astellas Policies and Procedures.‌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 PAP Governance Committee Independent Charity Group from the commercial organization.‌organization.

Budgeting Process. AmgenInsys’s PAP Governance Committee Independent Charity Group shall establish a budget process to be followed for ▇▇▇▇▇’s donations to Independent Charity PAPs that meets the following requirements: a. The PAP Governance Committee 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.department.‌ b. Amgen Insys shall approve the annual budget for donations to Independent Charity PAPs through at a process or level within the organization that does not include, nor is influenced by, above the commercial organization (e.g., at the Amgen Finance Department).‌‌executive level).‌‌ c. The PAP Governance Committee 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 PAP Governance Committee 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 PAP Governance CommitteeIndependent 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 Amgen Insys Policies and 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 PAP Governance Committee Independent Charity Group from the commercial organization.‌

Budgeting Process. Amgen’s PAP Governance Committee Pfizer shall establish a budget process to be followed for ▇▇▇▇▇Pfizer’s donations to Independent Charity PAPs that meets the following requirements: a. PAPs. The PAP Governance Committee Independent Charity Group shall develop an the 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 legal and compliance department. b. Amgen departments. The commercial business units shall approve have no involvement in the annual budget or allocation process, and the budget to be used for donations to Independent Charity PAPs through shall not be based on monies allocated to the Independent Charity Group from the commercial business units. The ELT (or a process or organization that does not include, nor subset thereof) shall approve the total annual amount available for donations to Independent Charity PAPs. After the total annual amount is influenced byapproved, the commercial organization (e.g., the Amgen Finance Department).‌‌ c. The PAP Governance Committee Independent Charity Group shall have sole responsibility for allocating the approved budget amount across donations to Independent Charity PAPs and to any disease state fund established by the Independent Charity PAP.‌ d. PAP.‌ The PAP Governance Committee Independent Charity Group shall have sole responsibility for assessing handling requests for additional or supplemental funding from Independent Charity PAPs outside of the annual budget using standardizedapproved amount and for requesting additional funding and seeking approval from the ELT (or a subset thereof), for donations to Independent Charity PAPs outside of the annual approved amount. Such requests shall be assessed against objective criteria established by the PAP Governance CommitteeIndependent Charity Group. Any such requests also shall be subject to Pfizer legal and compliance personnel shall also be involved in the review and approval, approval of requests for additional or supplemental funding. The purpose of this review shall be 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 Amgen Policies Pfizer policies and 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 PAP Governance Committee from the commercial organization.‌procedures.

Budgeting Process. Amgen’s PAP Governance Committee Within 90 days after the Effective Date, United Therapeutics’ Independent Interaction Team shall establish a budget process to be followed for ▇▇▇▇▇’s United Therapeutics’ donations to Independent Charity PAPs that meets the following requirements: a. PAPs. The PAP Governance Committee Independent Charity Interaction Team shall develop propose 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. Amgen shall approve the annual budget for donations to Independent Charity PAPs through a process or organization that does not include, nor is influenced by, the commercial organization (e.g., the Amgen Finance Department).‌‌ c. The 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 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 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 Amgen Policies and 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 PAP Governance Committee Independent Charity Interaction Team from the commercial organization.‌organization. United Therapeutics 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). After the annual budget is approved, the Independent Charity Interaction Team 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. The Independent Charity Interaction Team shall have sole responsibility for assessing requests for additional or supplemental funding from Independent Charity PAPs outside of the annual budget. Such requests shall be assessed against standardized, objective criteria established by the Independent Charity Interaction Team. United Therapeutics legal and compliance personnel shall also be involved in the review and approval of requests for additional/supplemental funding. The purpose of this review shall be 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 United Therapeutics Policies and Procedures.

Budgeting Process. AmgenSanofi’s PAP Governance Committee Independent Charity Group shall establish a budget process to be followed for ▇▇▇▇▇Sanofi’s donations to Independent Charity PAPs that meets the following requirements: a. The PAP Governance Committee 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.department.‌ b. Amgen Sanofi shall approve the annual budget for donations to Independent Charity PAPs through at a process or level within the organization that does not include, nor is influenced by, above the commercial organization (e.g., at the Amgen Finance Department).‌‌executive level).‌‌ c. The PAP Governance Committee 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 PAP Governance Committee 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 PAP Governance CommitteeIndependent 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 Amgen Sanofi Policies and 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 PAP Governance Committee Independent Charity Group from the commercial organization.‌

Budgeting Process. Amgen’s PAP Governance Novartis’ ICCF Executive Committee shall establish a budget process to be followed for ▇▇▇▇▇’s Novartis’ donations to Independent Charity PAPs that meets the following requirements: a. The PAP Governance 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. b. Amgen Novartis shall approve the annual budget for donations to Independent Charity PAPs through at a process or level within the organization that does not include, nor is influenced by, above the commercial organization (e.g., at the Amgen Finance Department).‌‌executive level). c. The PAP Governance 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 PAP Governance 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 PAP Governance 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 Amgen Novartis Policies and Procedures.‌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 PAP Governance ICCF Executive Committee from the commercial organization.‌organization.