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)
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.)
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)