Results to be Included in Report. The following results shall be included in each Transaction Review Report:
Results to be Included in Report. The following results shall be included in each Transactions Review Report:
(a) a list of the disease funds reviewed by the IRO for the applicable Reporting Period;
(b) for each disease fund reviewed by the IRO, a description of the review conducted by XXX;
(c) for each disease fund reviewed by the IRO, findings regarding whether PANF complied with each element of the PAP Measures outlined in Section III.F of the IA;
(d) for each disease fund reviewed, the IRO’s (i.e., the Legal Reviewer’s) determination as to whether or not PANF complied with the Federal Anti-Kickback Statute and applicable OIG guidance relating to Patient Assistance Related Functions and an explanation of the legal analysis that forms the basis for such determination; and
(e) recommendations, if any, for changes in PANF’s systems, processes, policies, procedures, and practices that would correct or address any weaknesses or deficiencies uncovered during the Transactions Review with respect to its Patient Assistance Related Functions.
Results to be Included in Report. The following results shall be included in each Transactions Review Report: (for the review of Independent Charity PAP arrangements)
a) a list of the Independent Charity PAP funds to which Amgen made donations during the Reporting Period;
b) for each Independent Charity PAP arrangement reviewed by the IRO, a description of the review conducted by the IRO;
c) for each Independent Charity PAP arrangement reviewed by the IRO, findings regarding each element specified above in Sections IV.A.1-8;
d) for each Independent Charity PAP arrangement reviewed by the IRO, a statement as to whether Amgen identified any compliance issues associated with the arrangement;
e) the findings and supporting rationale regarding any overall weaknesses in Amgen’s systems, processes, policies, procedures, and practices relating to its arrangements and interactions with Independent Charity PAPs; and
f) recommendations, if any, for changes in Amgen’s systems, processes, policies, procedures, and practices that would correct or address any weaknesses or deficiencies uncovered during the Transactions Review with respect to its arrangements and interactions with Independent Charity PAPs. (Relating to the IRO Review of Additional Items (if required))
a) for each Additional Item reviewed, a description of the review conducted;
b) for each Additional Item reviewed, the IRO’s findings based on its review;
c) for each Additional Item reviewed, the findings, and supporting rationale regarding any weaknesses in Amgen’s systems, processes, policies, procedures, and practices relating to the Additional Item; and
d) for each Additional Item reviewed, recommendations, if any, for changes in Amgen’s systems, processes, policies, and procedures that would correct or address any weaknesses or deficiencies uncovered during the review.
Results to be Included in Report. The following results shall be included in each Transactions Review Report:
a. Relating to the Review of Co-Marketing Activities.
i. a description of each Co-Marketing Activity reviewed and an identification of the types of documents and information reviewed for each Co-Marketing Activity reviewed;
ii. for each Co-Marketing Activity reviewed, the IRO’s findings and supporting rationale as to:
(a) Xxxxxxx’s determination of the business need for entering into the Co-Marketing Activity with the ECP(s) and ECI(s) and the role and contribution of each ECP or ECI involved in the Co-Marketing Activity, including the financial value of the contribution;
(b) whether Essilor is appropriately tracking each Co- Marketing Activity in a centralized, electronic system;
(c) Essilor’s process for evaluating the fair market value of the Co-Marketing Activity;
(d) whether Essilor reviewed and approved each Co- Marketing Activity in accordance with Essilor’s Policies and Procedures; and
(e) whether Essilor appropriately documented each Co- Marketing Activity in a written agreement that described the scope of work to be performed by all parties to the arrangement, the fees to be paid, and any work product to be produced.
iii. whether the IRO identified any weaknesses in Essilor’s systems, processes, policies, procedures, and/or practices relating to Co-Marketing Activities and any recommendations for improvements to Essilor’s systems, processes, policies, procedures and/or practices relating to Co-Marketing Activities.
Results to be Included in Report. The following results shall be included in each Additional Items Review Report:
a. for each Additional Item reviewed, a description of the review conducted;
b. for each Additional Item reviewed, the IRO’s findings based on its review;
c. for each Additional Item reviewed, the findings and supporting rationale regarding any weaknesses in Essilor’s systems, processes, policies, procedures, and practices relating to the Additional Item, if any; and
d. for each Additional Item reviewed, recommendations, if any, for changes in Essilor’s systems, processes, policies, and procedures that would correct or address any weaknesses or deficiencies uncovered during the review.
Results to be Included in Report. The following results shall be included in each Transactions Review Report:
(a) a list of the disease funds reviewed by the IRO for the applicable Reporting Period;
(b) for each disease fund reviewed by the IRO, a description of the review conducted by XXX;
(c) for each disease fund reviewed by the IRO, findings regarding whether Good Days complied with each element of the PAP Measures outlined in Section III.F of the IA;
(d) for each disease fund reviewed, the IRO’s (i.e., the Legal Reviewer’s) determination as to whether or not Good Days complied with the Federal Anti-Kickback Statute and applicable OIG guidance relating to Patient Assistance Related Functions and an explanation of the legal analysis that forms the basis for such determination; and
(e) recommendations, if any, for changes in Good Days’ systems, processes, policies, procedures, and practices that would correct or address any weaknesses or deficiencies uncovered during the Transactions Review with respect to its Patient Assistance Related Functions.
Results to be Included in Report. The following results shall be included in each Promotional and Product Services Review Report:
a. A narrative explanation of the IRO’s findings and supporting rationale (including reasons for Errors and patterns noted, etc.) based on the Inquiries conducted as part of the Transactions Review.
b. A narrative explanation of the IRO’s findings and supporting rationale regarding any weaknesses in Spectranetics’s systems, processes, policies, procedures, and practices relating to the Inquiries, if any;
c. recommendations for improvement in Spectranetics’s systems, processes, policies, procedures, and practices relating to the Inquiries; and
d. a spreadsheet identifying by Sampling Unit the results of each Inquiry.
Results to be Included in Report. The following results shall be included in each Transactions Review Report:
(i) a list of the disease funds reviewed by the IRO for the applicable Reporting Period;
(ii) for each disease fund reviewed by the IRO, a description of the review conducted by XXX;
(iii) for each disease fund reviewed by the IRO, findings regarding whether PSI complied with each element of the PAP Measures outlined in Section III.F of the IA;
(iv) for each disease fund reviewed, the IRO’s (i.e., the Legal Reviewer’s) determination as to whether or not PSI complied with the Federal Anti-Kickback Statute and applicable OIG guidance relating to Patient Assistance Related Functions and an explanation of the legal analysis that forms the basis for such determination; and
(v) recommendations, if any, for changes in PSI’s systems, processes, policies, procedures, and practices that would correct or address any weaknesses or deficiencies uncovered during the Transactions Review with respect to its Patient Assistance Related Functions.
Results to be Included in Report. The following results shall be included in each Transactions Review Report:
a. Relating to the Review of Co-Marketing Activities
(i) whether and how CSI determined a business need for performing the Co-Marketing Activities with the HCP(s) and the HCI(s);
(ii) whether and how the targets or audience of each Co-Marketing Activity were selected, and by whom;
(iii) the contributions of each party to each Co-Marketing Activity, and the financial value of those contributions;;
(iv) whether and how CSI determined that each party was contributing and receiving fair market value to the Co-Marketing Activities;
(v) whether the Co-Marketing Activity was reviewed and approved in accordance with CSI's Policies and Procedures;
(vi) whether CSI collected and retained records of the activities of each party to the Co-Marketing Activities;
(vii) any weaknesses in CSI’s systems, processes, policies, procedures and/or practices relating to Co-Marketing Activities; and
(viii) any recommendations for improvements to CSI’s systems, processes, policies, procedures and/or practices relating to Co-Marketing Activities.
Results to be Included in Report
