Transactions Review Clause Samples

Transactions Review. A. At least thirty (30) days prior to the end of each Reporting Period, Amgen shall submit to OIG a list of all Amgen Government Reimbursed Products and shall notify OIG about the risks identified for each Government Reimbursed Product and the types of risk mitigation activities undertaken in connection with each Government Reimbursed Product. Prior to the end of the applicable Reporting Period, OIG shall select up to three Amgen Government Reimbursed Products (each a “Selected Product” and together the “Selected Products”) to be reviewed in connection with the Transactions Review. B. For each Reporting Period and for each Selected Product, the IRO shall conduct a review of: (i) the applicable Product Profile, Product Risk Matrix, Summary Report, and Risk Mitigation Plans; (ii) documents and materials related to the development of the Risk Mitigation Plans for the Selected Product; and (iii) documents and materials relating to the implementation of the Risk Mitigation Plans applicable to the Selected Product. The IRO shall also interview the Amgen personnel responsible for the development of the Product Risk Matrix and Summary Report, and the Amgen Compliance organization personnel responsible for overseeing the development and implementation of the risk monitoring and auditing activities and risk mitigation action items specified in the Risk Mitigation Plans. The objective of the IRO shall be to: (i) understand the standards and processes followed by Amgen in developing the applicable Risk Mitigation Plans for each Selected Product;

Transactions Review. The Transactions Review shall include a review of: (1) a sample of consultant or other fee-for-service arrangements entered into with HCPs (including all events and expenses related to such engagements or arrangements), (2) a sample of medical education grants and charitable contributions involving HCPs and HCIs, and (3) a sample of Payments.‌

Transactions Review. For each Reporting Period of the CIA, the Compliance Expert shall perform the Transactions Review. The Transactions Review shall be based on a review of a sample of Life Sciences and Healthcare Sector Engagements completed during the applicable Reporting Period. The Compliance Expert shall report on all aspects of each Transaction Review in each Transactions Review Report.

Transactions Review. The Transactions Review shall include a review of the following: (1) records relating to a sample of the Payments that are reported by Biovail pursuant to Section III.J of the CIA; (2) Biovail’s call plans related to the promotion, marketing, or sale of Government Reimbursed Products in the U.S. and Biovail’s call plan review process for Government Reimbursed Products; (3) U.S. Sampling Events as defined below in Section III.C; and (4) Inquiries reflected in Biovail’s Inquiries Database. The IRO shall report on all aspects of its reviews in the Transactions Review Reports. A. IRO Review of Payment Listings 1. Information Contained in U.S.-based Physician Payment Listings As set forth in Section III.J of the CIA, Biovail shall post quarterly and annual listings of U.S.-based physicians, U.S.-based Related Entities and U.S.-based Product Decision-Makers who received Payments, as defined in the CIA, directly or indirectly from Biovail. For purposes of the Transaction Review, each annual listing shall be referred to as the “Payment Listing” or “Listing.” For each entry, the Listing shall include the following information: i) physician’s or Product Decision-Maker’s full name; ii) name of Related Entity (if applicable); iii) city and state of the physician’s practice, the Related Entity (as applicable), or the Product Decision-Maker; iii) the purpose of the Payment; and iii) the aggregate value of the Payment(s) in the preceding quarter(s) or year. For purposes of the Transaction Review, the term “Control Documents” shall include all documents or electronic records associated with each Payment reflected in the Payment Listing for the sampled U.S.-based physician, U.S.-based Related Entity, and/or U.S.-based Product Decision-Maker. For example, the term, “Control Documents” includes, but is not limited to, documents relating to the nature, purpose, and amount of all Payments reflected in the Listing; contracts relating to the Payment(s) reflected in the Listing; documents relating to the occurrence of Payment(s) reflected in the Listing; documents reflecting any work product generated or service provided in connection with the Payment(s); documents submitted in connection with requests for approval for the Payment(s); and business rationale or justification forms relating to the Payment(s).

Transactions Review. The Transactions Review shall include a review of performance standards applicable to Government Reimbursed Products for which PMAs or supplements to PMAs were submitted to FDA and may also include a review of an Additional Item.

Transactions Review. The Open Primary reserves the right to perform a Transactions Review upon each request for a creation, loading and refund of the amounts in your RedPak account to ensure that any current transaction is consistent with such earlier transactions and/or that it is for amounts payable under an existing or imminent contract for education services executed through ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇.