Independent Medical Education Activities Controls, Donations Controls, and Sponsorships Controls Sample Clauses

Independent Medical Education Activities Controls, Donations Controls, and Sponsorships Controls. Amgen implemented prior to the Effective Date, and shall continue to maintain throughout the term of this CIA, Compliance Controls for Independent Medical Education (as defined in Section II.C.9) activities. Amgen represents that these controls ensure, among other factors, that: (i) all Independent Medical Education activity funding requests are reviewed, tracked, and evaluated by the Compliance organization to ensure that the requests meet compliance criteria; (ii) funding decisions are based on objective criteria such as: the qualifications of the requestor, the quality of the Independent Medical Education activity program, and Amgen’s pre- established educational goals; (iii) Independent Medical Education activity funding is provided only pursuant to a written agreement with the funding recipient and payments Corporate Integrity Agreement Amgen Inc. made to the Independent Medical Education activity funding recipient comply with the express terms of the written agreement; and (iv) Amgen staff are not involved in the development or implementation of Independent Medical Education activity programs funded by Amgen (collectively, the “Independent Medical Education Activity Controls”). Amgen implemented prior to the Effective Date, and shall continue to maintain throughout the term of this CIA, Compliance Controls for Donations to ensure that Amgen’s Donations comply with all applicable Federal health care program and FDA requirements (Donations Controls). Amgen represents that the Donations Controls ensure, among other factors, that: (i) Donations are provided to a qualified recipient which is a tax-exempt or not-for-profit entity; (ii) Donations are not linked, directly or indirectly, to any agreement to use Amgen’s products or to reward past business; (iii) Amgen does not fund any Donations request until the request is approved and an executed agreement is in place; and (iv) Donations payments are made consistent with the approval letter and written agreement. In addition, Amgen implemented prior to the Effective Date, and shall continue to maintain throughout the term of this CIA, Compliance Controls for Sponsorships to ensure that Amgen’s Sponsorships comply with all applicable Federal health care program and FDA requirements (Sponsorships Controls). Amgen represents that the Sponsorships Controls ensure, among other factors, that: (i) a legitimate business purpose for the Sponsorship exists; (ii) a tangible benefit for the Sponsorship exists; (iii) pro...
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