Common use of Budgeting Process Clause in Contracts

Budgeting Process. Sanofi’s 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 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. Sanofi 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 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 Independent Charity Group from the commercial organization.‌

Budgeting Process. SanofiInsys’s Independent Charity Group shall establish a budget process to be followed for SanofiXxxxx’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. Sanofi 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 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 Sanofi 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 Independent Charity Group from the commercial organization.‌

Budgeting Process. Sanofi’s Within 90 days after the Effective Date, United Therapeutics’ Independent Charity Group Interaction Team shall establish a budget process to be followed for Sanofi’s United Therapeutics’ donations to Independent Charity PAPs that meets the following requirements: a. PAPs. The Independent Charity Group 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. Sanofi 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 Groupdepartment. 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 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 Independent Charity Group 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. Sanofi’s Independent Charity Group Pfizer shall establish a budget process to be followed for SanofiPfizer’s donations to Independent Charity PAPs that meets the following requirements: a. PAPs. The 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 compliance department.‌ b. Sanofi 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 Sanofi Policies and Procedures.‌ e. departments. The commercial organization business units shall have no involvement in the budget or allocation 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.‌business units. The ELT (or a subset thereof) shall approve the total annual amount available for donations to Independent Charity PAPs. After the total annual amount is approved, the Independent Charity Group shall have sole responsibility for allocating the approved amount across donations to Independent Charity PAPs and to any disease state fund established by the Independent Charity PAP.‌ The Independent Charity Group shall have sole responsibility for handling requests for additional or supplemental funding from Independent Charity PAPs outside of the annual approved 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 Independent Charity Group. Pfizer legal and compliance personnel shall also be involved in the review and 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 Pfizer policies and procedures.