Common use of Contribution and Assistance Related Functions Systems Review Clause in Contracts

Contribution and Assistance Related Functions Systems Review. The Contribution and Assistance Related Functions Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Novartis relating to Contribution and Assistance Related Functions. Where practical, Novartis personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Novartis in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Novartis associated with the following (hereafter “Reviewed Policies and Procedures”): 1. Novartis’ systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) Independent Charity PAPs as defined in Section II.C.8 of the CIA. This review shall include an assessment of the following: a. Novartis’ organizational structure as it relates to arrangements and interactions with Independent Charity PAPs, including: i. the identification of all those individuals, departments, or groups within Novartis (e.g., the ICCF Executive Committee) that have responsibility for, or involvement with, such arrangements and interactions; ii. the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs; iii. the identification of those individuals, departments, or groups within Novartis (e.g., the commercial organization) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and iv. the manner by which the separation of Independent Charity PAP-related responsibilities from the commercial organization is enforced. b. Novartis’ written policies and procedures as they relate to arrangements and interactions with Independent Charity PAPs, including: i. the criteria governing whether and under what circumstances Novartis would donate to an Independent Charity PAP or any specific disease state fund of such a PAP; ii. communications (including any limitations on such communications) between any representatives of Novartis and any Independent Charity PAP (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications including the exchange of any data); iii. communications (including any limitations on such communications) between those individuals, departments, or groups within Novartis with responsibility for Independent Charity PAPs and the commercial organization of Novartis (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications); and iv. communications (including any limitations on such communications) between representatives of Novartis and health care providers or patients regarding assistance available through any Independent Charity PAP. c. Novartis’ policies and practices as they relate to the budgeting process applicable to donations to Independent Charity PAPs as outlined in Section III.Q.2 of the CIA, including as it relates to initial or annual donation amounts and any supplemental amounts; d. Novartis’ policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to donate (or continue to donate) to an Independent Charity PAP; and ii) the amount of the donation (including any initial or annual amount and any supplemental amount); e. Novartis’ criteria, policies, and practices as they relate to donations made by Novartis to any Independent Charity PAPs as referenced in Section III.Q.3, including the internal review process followed in connection with any donations to Independent Charity PAPs; and f. Novartis’ policies and practices as they relate to information provided, directly or indirectly, to the public about the availability of patient assistance for Novartis’ products. 2. Novartis’ systems, policies, processes, and procedures relating to any Novartis PAPs, as defined in Section II.C.8 of the CIA. This review shall include an assessment of the following: a. The general elements of Novartis PAPs, including: i. the types of assistance that are made available through Novartis PAPs; ii. the types of patients to whom each type of assistance is made available; iii. the eligibility criteria for the various types of assistance provided; iv. the controls used to implement the eligibility criteria (i.e., controls employed to ensure that appropriate patients receive the various types of assistance); v. the maintenance of records regarding free product and other assistance provided to or through Novartis PAPs; and vi. Novartis’ external communications about Novartis PAPs, including communication between Novartis and/or Novartis PAPs, and Medicare Part D Plans. b. Novartis’ policies and practices as they relate to the budgeting process for financial or in-kind assistance provided under any Novartis PAP, including as they relate to initial or annual donation amounts and any supplemental amounts; c. Novartis’ policies and practices as they relate to the process by which decisions about the following are made and approved: (i) whether to provide (or continue to provide) assistance through any Novartis PAP; and (ii) the amount (or value) of the assistance to be provided through each program (including any initial or annual amount and any supplemental amount); and d. Novartis’ policies and practices as they relate to any contracts or arrangements entered between Novartis and outside entities relating to any Novartis PAPs or the distribution of free product, including the individuals, groups, or departments involved in the negotiation process, the requirements and terms of the contracts or arrangements, and the review and approval of such contracts or arrangements.

Contribution and Assistance Related Functions Systems Review. The Contribution and Assistance Related Functions Systems Review shall be a review of Mallinckrodt’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Novartis relating to Contribution and Assistance Related Functions. Where practical, Novartis Mallinckrodt personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Novartis Mallinckrodt in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Novartis Mallinckrodt associated with the following (hereafter “Reviewed Policies and Procedures”): 1. Novartis’ Mallinckrodt’s systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) independent third-party patient assistance programs (Independent Charity PAPs as defined in Section II.C.8 of the CIAPAPs). This review shall include an assessment of the following: a. Novartis’ ▇. ▇▇▇▇▇▇▇▇▇▇▇▇’▇ organizational structure as it relates to arrangements and interactions with Independent Charity PAPs, including: i. the identification of all those individuals, departments, or groups within Novartis Mallinckrodt (e.g.including, the ICCF Executive Committeebut not limited to, Mallinckrodt’s Compliance Officer, Legal, and Medical Affairs) that have responsibility for, or involvement with, such arrangements and interactions; ii. the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs; ; iii. the identification of those individuals, departments, or groups within Novartis Mallinckrodt (e.g., the commercial organization) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and iv. the manner by which the separation of Independent Charity PAP-related responsibilities from the commercial organization is enforced. b. Novartis’ written policies and procedures as they relate to arrangements and interactions with Independent Charity PAPs, including: i. the criteria governing whether and under what circumstances Novartis would donate to an Independent Charity PAP or any specific disease state fund of such a PAP; ii. communications (including any limitations on such communications) between any representatives of Novartis and any Independent Charity PAP (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications including the exchange of any data); iii. communications (including any limitations on such communications) between those individuals, departments, or groups within Novartis with responsibility for Independent Charity PAPs and the commercial organization of Novartis (including the identity of individuals authorized to engage in such communications, the circumstances of such communications, and the subject matter of such communications); and iv. communications (including any limitations on such communications) between representatives of Novartis and health care providers or patients regarding assistance available through any Independent Charity PAP. c. Novartis’ policies and practices as they relate to the budgeting process applicable to donations to Independent Charity PAPs as outlined in Section III.Q.2 of the CIA, including as it relates to initial or annual donation amounts and any supplemental amounts; d. Novartis’ policies and practices as they relate to the process by which decisions about the following are made and approved: i) whether to donate (or continue to donate) to an Independent Charity PAP; and ii) the amount of the donation (including any initial or annual amount and any supplemental amount); e. Novartis’ criteria, policies, and practices as they relate to donations made by Novartis to any Independent Charity PAPs as referenced in Section III.Q.3, including the internal review process followed in connection with any donations to Independent Charity PAPs; and f. Novartis’ policies and practices as they relate to information provided, directly or indirectly, to the public about the availability of patient assistance for Novartis’ products. 2. Novartis’ systems, policies, processes, and procedures relating to any Novartis PAPs, as defined in Section II.C.8 of the CIA. This review shall include an assessment of the following: a. The general elements of Novartis PAPs, including: i. the types of assistance that are made available through Novartis PAPs; ii. the types of patients to whom each type of assistance is made available; iii. the eligibility criteria for the various types of assistance provided; iv. the controls used to implement the eligibility criteria (i.e., controls employed to ensure that appropriate patients receive the various types of assistance); v. the maintenance of records regarding free product and other assistance provided to or through Novartis PAPs; and vi. Novartis’ external communications about Novartis PAPs, including communication between Novartis and/or Novartis PAPs, and Medicare Part D Plans. b. Novartis’ policies and practices as they relate to the budgeting process for financial or in-kind assistance provided under any Novartis PAP, including as they relate to initial or annual donation amounts and any supplemental amounts; c. Novartis’ policies and practices as they relate to the process by which decisions about the following are made and approved: (i) whether to provide (or continue to provide) assistance through any Novartis PAP; and (ii) the amount (or value) of the assistance to be provided through each program (including any initial or annual amount and any supplemental amount); and d. Novartis’ policies and practices as they relate to any contracts or arrangements entered between Novartis and outside entities relating to any Novartis PAPs or the distribution of free product, including the individuals, groups, or departments involved in the negotiation process, the requirements and terms of the contracts or arrangements, and the review and approval of such contracts or arrangements.