IRO Review of Arrangements with Independent Charity PAPs Clause Samples

IRO Review of Arrangements with Independent Charity PAPs. The IRO shall conduct a review and assessment of United Therapeutics’ compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which United Therapeutics entered charitable donation arrangements during the Reporting Period. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP reviewed: 1) all budget-related documents; 2) all documents relating to any decision to provide donations to the Independent Charity PAP; 3) any agreements between United Therapeutics and the Independent Charity PAP; 4) all email, correspondence and other documents reflecting communications and interactions between United Therapeutics and the Independent Charity PAP; 5) all email, correspondence and other documents reflecting communications and interactions within United Therapeutics (or between United Therapeutics and any entity acting on its behalf) relating to the arrangement with the Independent Charity PAP; and 6) other available information relating to the arrangements and interactions between United Therapeutics and the selected Independent Charity PAP. In addition to reviewing documents and written materials, the IRO shall also interview individuals at United Therapeutics who have responsibility for arrangements and interactions with Independent Charity PAPs. For each Independent Charity PAP selected as part of the IRO review, the IRO shall assess the Reviewed Materials and conduct interviews to evaluate whether the Independent Charity PAP-related activities were conducted in a manner consistent with United Therapeutics’ policies and procedures including those described in Section III.J of the CIA and with OIG guidance. More specifically, the IRO Review shall evaluate and identify: 1) Whether activities relating to arrangements and interactions with the Independent Charity PAP were undertaken by the appropriate individuals, departments, or groups within United Therapeutics in accordance with the company’s policies and procedures including those outlined in Section III.J of the CIA; 2) Whether United Therapeutics’ commercial organization (as defined in Section III.J) played a role in any arrangement or interaction with the Independent Charity PAP in violation of United Therapeutics’ policies and procedures or OIG gu...
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IRO Review of Arrangements with Independent Charity PAPs. The IRO shall conduct a review and assessment of Amgen’s compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review fifty percent (50%) of the donation arrangements that Amgen entered into with Independent Charity PAPs during the Reporting Period for which the IRO is conducting the Transactions Review. Amgen has represented that, as a matter of practice, Amgen enters a separate agreement with an Independent Charity PAP for each disease state fund of the PAP to which Amgen makes a donation. Amgen shall provide the IRO with a list of all Independent Charity PAPs with which Amgen entered into a donation agreement during the Reporting Period under review (the “applicable Reporting Period”). The IRO will randomly select and review 50% of these donation arrangements for the applicable Reporting Period. For purposes of the Independent Charity PAP Transactions Review, the term “Reviewed Materials” shall mean the following for each Independent Charity PAP arrangement reviewed: 1) the Annual Notice from Amgen to Independent Charity PAPs (which announces Amgen’s willingness to consider written requests for contributions and seeks information regarding: anticipated patient need for particular disease state funds; patient eligibility criteria used by the Independent Charity PAPs; and information about the Independent Charity PAPs);
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IRO Review of Arrangements with Independent Charity PAPs. The IRO shall conduct a review and assessment of Jazz’s compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Jazz entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP arrangement reviewed:
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IRO Review of Arrangements with Independent Charity PAPs. ‌ The IRO shall conduct a review and assessment of Jazz’s compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Jazz entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP arrangement reviewed: 1) the information on Jazz’s website regarding Corporate Giving, including the online application portal through which Independent Charity PAPs must submit written requests for contributions; 2) donation requests from Independent Charity PAPs (which includes information on the particular disease state funds; details regarding patient eligibility criteria used by the Independent Charity PAPs; and information about the Independent Charity PAPs (e.g., information about administrative fees, patient grant amounts, average processing time to assist patients, etc.));‌‌ 3) the approved annual budget for charitable giving, allocating the budget for donations to Independent Charity PAPs, and to any disease state funds established by the Independent Charity PAPs;‌ 4) documentation that shows the objective criteria used to evaluate Independent Charity PAPs and the allocation of the approved budget across disease states and Independent Charity PAPs (e.g., Corporate Giving Executive Review Committee presentations and related documentation; documentation of due diligence performed by Jazz; and other relevant information, as applicable);‌ 5) documents regarding donations to Independent Charity PAPs required by Jazz policy to evidence or document the review and approval of a decision to provide a donation to a particular fund of an Independent Charity PAP (i.e., minutes from Jazz’s Corporate Giving Executive Review Committee that memorialize donation decisions, including budget allocation across disease states and Independent Charity PAPs, and final determinations (approvals or rejections) on proposed donations to Independent Charity PAPs);‌ 6) to the extent not covered by item 2 above, all correspondence between Jazz and an Independent Charity PAP relating to any donation arrangement with the Independent Charity PAP;
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IRO Review of Arrangements with Independent Charity PAPs. ‌ The IRO shall conduct a review and assessment of Astellas’ compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Astellas entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP reviewed: 1) all budget-related documents;‌
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IRO Review of Arrangements with Independent Charity PAPs. ‌ The IRO shall conduct a review and assessment of Lundbeck’ compliance with the Independent Charity PAP processes, policies, and procedures outlined in Section III.J of the CIA. More specifically, the IRO shall review the arrangements and interactions with all Independent Charity PAPs or disease state funds with which Lundbeck entered charitable donation arrangements during the Reporting Period for which the IRO is conducting the review. For purposes of this IRO review, the term “Reviewed Materials” shall include the following for each Independent Charity PAP reviewed: 1) all budget-related documents;‌
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