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AstraZeneca - CIA

AstraZeneca - CIA

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Published by: Govtfraudlawyer on Feb 26, 2011
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02/26/2011

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Corporate Integrity AgreementAstraZeneca
 
1
CORPORATE INTEGRITY AGREEMENT
BETWEEN THE
 O
FFICE OF
I
NSPECTOR
G
ENERAL
 
OF THE
 D
EPARTMENT OF
H
EALTH AND
H
UMAN
S
ERVICES
 
AND
 A
STRA
Z
ENECA
P
HARMACEUTICALS
LP
AND
A
STRA
Z
ENECA
LPI. P
REAMBLE
 AstraZeneca Pharmaceuticals LP and AstraZeneca LP (collectively“AstraZeneca”) hereby enter into this Corporate Integrity Agreement (CIA) with theOffice of Inspector General (OIG) of the United States Department of Health and HumanServices (HHS) to promote compliance with the statutes, regulations, and writtendirectives of Medicare, Medicaid, and all other Federal health care programs (as definedin 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements) and with thestatutes, regulations, and written directives of the Food and Drug Administration (FDArequirements).  Contemporaneously with this CIA, AstraZeneca is entering into aSettlement Agreement with the United States.  AstraZeneca will also enter into settlementagreements with various States (State Settlement Agreement and Release) andAstraZeneca’s agreement to this CIA is a condition precedent to those agreements. Prior to the Effective Date, AstraZeneca initiated certain voluntary compliancemeasures and established a voluntary compliance program designed to address its U.S.operations and compliance with Federal health care program and FDA requirements (U.S.Compliance Program).  AstraZeneca shall continue its U.S. Compliance Programthroughout the term of the CIA and shall do so in accordance with the terms set forthbelow.  AstraZeneca may modify its U.S. Compliance Program, as appropriate, but at aminimum, AstraZeneca shall ensure that during the term of this CIA, it shall comply withthe obligations set forth in this CIA.
 
 
 
  
Corporate Integrity AgreementAstraZeneca
 
2
II. T
ERM AND
S
COPE OF THE
CIA
  A.  The effective date of this CIA shall be the date on which the final signatoryexecutes this document (Effective Date.)  The period of the compliance obligationsassumed by AstraZeneca under this CIA shall be five years from the Effective Dateunless otherwise specified.  Each one-year period, beginning with the one-year periodfollowing the first day of the first calendar month following the Effective Date, shall bereferred to as a “Reporting Period.” B.  Sections VII, IX, X, and XI shall expire no later than 120 days after OIG'sreceipt of:  (1) AstraZeneca’s final Annual Report; or (2) any additional materialssubmitted by AstraZeneca pursuant to OIG’s request, whichever is later. C.  The scope of this CIA shall be governed by the following definitions: 1.  “Covered Persons” includes:
 
 a. all owners of AstraZeneca and any AstraZeneca Affiliate (asdefined below) who are natural persons (other than shareholderswho: (1) have an ownership interest of less than 5% and (2) acquiredthe ownership interest through public trading); b.  all directors of AstraZeneca PLC; c.  all officers, directors, and employees of AstraZeneca or anyAstraZeneca Affiliate who are:  1) based in the United States, or 2)based outside the United States and who have responsibilitiesrelating to Promotional Functions or Product Related Functions,except as carved out below in this Section II.C.1; and d. all contractors, subcontractors, agents, and other persons whoperform Promotional Functions or Product Related Functions in theUnited States on behalf of AstraZeneca or any AstraZeneca Affiliate. Notwithstanding the above, the term “Covered Persons” does notinclude:  (i)  employees, contractors, subcontractors, agents or otherpersonnel of Global Operations or Global Discovery, so long as they donot have responsibilities relating to Promotional Functions or Product
 
  
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.
 
 2.
 
“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.)
 
  6.
 
The term “Third Party Personnel” shall mean personnel who performPromotional Functions or Product Related Functions who are employees

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