Corporate Integrity AgreementAllergan, Inc.
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
LLERGAN
,
I
NC
.I. P
REAMBLE
Allergan, Inc. (Allergan) hereby enters into this Corporate Integrity Agreement(CIA) with the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS) to promote compliance with the statutes, regulations,and written directives of Medicare, Medicaid, and all other Federal health care programs(as defined in 42 U.S.C. § 1320a-7b(f)) (Federal health care program requirements) andwith the statutes, regulations, and written directives of the Food and Drug Administration(FDA requirements). Contemporaneously with this CIA, Allergan is entering into aSettlement Agreement with the United States. Allergan will also enter into settlementagreements with various States (State Settlement Agreements) and Allergan’s agreementto this CIA is a condition precedent to those agreements.Prior to the Effective Date, Allergan established a voluntary compliance program(Compliance Program) and initiated certain voluntary compliance measures. Allerganshall continue its Compliance Program throughout the term of the CIA and shall do so inaccordance with the terms set forth below. Allergan may modify its ComplianceProgram, as appropriate, but at a minimum, Allergan shall ensure that during the term of this CIA, it shall comply with the obligations set forth in this CIA.
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 Allergan under this CIA shall be five years from the Effective Date of thisCIA, unless otherwise specified. Each one-year period, beginning with the one-yearperiod following the first day of the first calendar month following the Effective Date,shall be referred to as a “Reporting Period.”
Corporate Integrity AgreementAllergan, Inc.
2B. Sections VII, X, and XI shall expire no later than 120 days after OIG's receiptof: (1) Allergan’s final Annual Report; or (2) any additional materials submitted byAllergan 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 Allergan and any Allergan Affiliate (as definedbelow) who are natural persons (other than shareholders who: (1)have an ownership interest of less than 5% and (2) acquired theownership interest through public trading);b. all officers, directors, and employees of Allergan or any AllerganAffiliate, who are: 1) based in the United States, or 2) based outsidethe United States and who have responsibilities relating toPromotional Functions or Product Related Functions, except ascarved out below in this Section II.C.1; andc. all contractors, subcontractors, agents, and other persons whoperform Promotional Functions or Product Related Functions in theUnited States on behalf of Allergan or any Allergan Affiliate.Notwithstanding the above, the term “Covered Persons” does not include:(i) employees, contractors, subcontractors, agents or other personnel of Allergan, or any Allergan Affiliate, who perform only manufacturing orbuilding and facilities functions (i.e., facilities maintenance, groundsmaintenance, and food services functions), so long as such personnel do nothave responsibilities relating to Promotional Functions or Product RelatedFunctions; and (ii) part-time or per diem employees, contractors,subcontractors, agents, and other persons who are not reasonably expectedto work more than 160 hours per year, except that any such individuals shallbecome “Covered Persons” at the point when they work more than 160hours during the calendar year.
Corporate Integrity AgreementAllergan, Inc.
32.
“Relevant Covered Persons” includes all Covered Persons whose jobresponsibilities relate to Promotional Functions or Product RelatedFunctions.3.
“Government Reimbursed Products” refers to all Allergan humanpharmaceutical products promoted or sold by Allergan or any AllerganAffiliate in the United States or pursuant to contracts with the UnitedStates 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 externaldissemination of promotional materials or information about, or theprovision of promotional services relating to, Government ReimbursedProducts, including those functions relating to any applicable reviewcommittees.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 anddistributed to healthcare professionals (HCPs) and healthcareinstitutions (HCIs) about Government Reimbursed Products, includingthose functions relating to any applicable review committees andAllergan’s Medical Affairs Department (Medical Affairs); (b)contracting with HCPs in the United States to conduct post-marketingclinical trials and other post-marketing studies (including Investigator-Initiated Trials (IITs)) 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 employeesof entities with whom Allergan or any Allergan Affiliate has or may inthe future (during the term of this CIA) enter into agreements to co-
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