Contribution and Assistance Related Functions Systems Review Sample Clauses

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, t...
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Related to Contribution and Assistance Related Functions Systems Review

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