Common use of Definition of Reportable Event Clause in Contracts

Definition of Reportable Event. For purposes of this CIA, a “Reportable Event” means anything that involves: (a) a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized; (b) a matter that a reasonable person would consider a probable violation of FDA requirements relating to the promotion of Government Reimbursed Products, unless otherwise reported to the FDA in accordance with Section III.K below; (c) the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; or (d) the filing of a bankruptcy petition by Indivior. A Reportable Event may be the result of an isolated event or a series of occurrences.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement (Indivior PLC)

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Definition of Reportable Event. For purposes of this CIA, a “Reportable Event” means anything that involves: (a) a. a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable to any Federal health care program for which penalties or exclusion may be authorized; (b) b. a matter that a reasonable person would consider a probable violation of FDA requirements relating to the promotion of Government Reimbursed Products, unless otherwise reported to the FDA in accordance with Section III.K below; (c) c. the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; or (d) d. the filing of a bankruptcy petition by IndiviorAegerion. A Reportable Event may be the result of an isolated event or a series of occurrences.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)

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Definition of Reportable Event. For purposes of this CIA, a “Reportable Event” means anything that involves:: ​ (a) a. a matter that a reasonable person would consider a probable violation of criminal, civil, or administrative laws applicable ​ ​ ​ to any Federal health care program for which penalties or exclusion may be authorized;; ​ (b) b. a matter that a reasonable person would consider a probable violation of FDA requirements relating to the promotion of Government Reimbursed Products, unless otherwise reported to the FDA in accordance with Section III.K III.J below;; ​ (c) c. the employment of or contracting with a Covered Person who is an Ineligible Person as defined by Section III.G.1.a; oror ​ (d) d. the filing of a bankruptcy petition by IndiviorMerit. A Reportable Event may be the result of an isolated event or a series of occurrences.. ​

Appears in 1 contract

Samples: Corporate Integrity Agreement (Merit Medical Systems Inc)

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