Corporate Integrity AgreementAstraZeneca
3Related Functions; and (ii) part-time or per diem employees, contractors,subcontractors, agents, and other persons who are not reasonablyexpected to work more than 160 hours per year, except that any suchindividuals shall become “Covered Persons” at the point when theywork more than 160 hours during the calendar year.
“Relevant Covered Persons” includes all Covered Persons whose jobresponsibilities relate to Promotional Functions or Product RelatedFunctions. 3.
“Government Reimbursed Products” refers to all AstraZeneca humanpharmaceutical products promoted or sold by AstraZeneca or anyAstraZeneca Affiliate in the United States or pursuant to contracts withthe United States that are reimbursed by Federal health care programs. 4.
The term “Promotional Functions” includes: (a) the selling, detailing,marketing, advertising, promoting, or branding of GovernmentReimbursed Products; and (b) the preparation or external disseminationof promotional materials or information about, or the provision of promotional services relating to, Government Reimbursed Products,including those functions relating to any applicable review committees. 5.
The term “Product Related Functions” includes: (a) the preparation orexternal dissemination of non-promotional materials (that are governedby Federal health care program and/or FDA requirements) aboutGovernment Reimbursed Products, including those functions relating toany applicable review committees and to AstraZeneca’s Medical AffairsDepartment (Medical Affairs); (b) contracting with healthcareprofessionals (“HCPs”) in the United States to conduct clinical trials andpost-marketing studies relating to Government Reimbursed Products; (c)authorship, publication, and disclosure of articles or study resultsrelating to Government Reimbursed Products; and (d) activities relatedto the submission of information about Government ReimbursedProducts in government-listed compendia (such as Drugdex or othercompendia of information about Government Reimbursed Products.)
The term “Third Party Personnel” shall mean personnel who performPromotional Functions or Product Related Functions who are employees