Common use of TERM AND SCOPE OF THE CIA Clause in Contracts

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Walgreens under this CIA shall be five years from the effective date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.” B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s receipt of: (1) Walgreens’ final Annual Report or (2) any additional materials submitted by Walgreens pursuant to OIG’s request, whichever is later. C. For purposes of this CIA, the term “Covered Persons” includes: 1. all owners of Walgreens and any Walgreens Affiliate who are natural persons (other than shareholders who: (a) have an ownership interest of less than 5% and (b) acquired the ownership interest through public trading). 2. all officers and directors of Walgreens; and, all officers and directors of any Walgreens Affiliate who engage in Covered Functions; 3. all employees of Walgreens or any Walgreens Affiliate who audit or are engaged in Covered Functions, as defined below in Section II.D.; 4. all Walgreens and Walgreens Affiliate contractors, subcontractors, agents, and other persons, excluding the Independent Review Organization, who audit or perform any of the Covered Functions. Notwithstanding the above, the term “Covered Persons” does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work for Walgreens or any Walgreens Affiliate more than 160 hours during a Reporting Period except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours for Walgreens or a Walgreens Affiliate during a Reporting Period.

TERM AND SCOPE OF THE CIA. ‌ A. The period of the compliance obligations assumed by Walgreens Avanir under this CIA shall be five years from the effective date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.””‌ B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s receipt of: (1) Walgreens’ Avanir’s final Annual Report Report; or (2) any additional materials submitted by Walgreens Avanir pursuant to OIG’s request, whichever is later.later.‌ C. The scope of this CIA is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: 1. (a) all owners of Walgreens and any Walgreens Affiliate Avanir who are natural persons (other than shareholders who: (ai) have an ownership interest of less than 5% and (bii) acquired the ownership interest through public trading).trading);‌ 2. (b) all officers and directors of Walgreens; and, ▇▇▇▇▇▇;‌ (c) all officers and directors employees of any Walgreens Affiliate Avanir who engage in Covered Functions; 3. all employees of Walgreens or any Walgreens Affiliate supervise personnel who audit or are engaged in Covered Functions, Functions (as defined below in Section II.D.;II.C.5); and‌ 4. (d) all Walgreens and Walgreens Affiliate contractors, subcontractors, agents, and other persons, excluding the Independent Review Organization, persons who audit or perform any of the Covered Functions on behalf of ▇▇▇▇▇▇ and who, in the course of performing Covered Functions. , either (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs) or consumers; or (ii) perform activities, provide services, or create materials relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by an Avanir employee who is a Covered Person prior to execution or dissemination.‌ Notwithstanding the above, the term “Covered Persons” does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work perform a Covered Function for Walgreens or any Walgreens Affiliate Avanir more than 160 hours during a Reporting Period per year, except that any such individuals individual shall become a “Covered PersonsPerson” at the point when they work more than 160 hours on a Covered Function for Walgreens or a Walgreens Affiliate Avanir during a Reporting Periodthe calendar year.

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Walgreens Aegerion under this CIA shall be five years from the effective date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.” B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s =s receipt of: (1) Walgreens’ Aegerion’s final Annual Report Report; or (2) any additional materials submitted by Walgreens Aegerion pursuant to OIG’s =s request, whichever is later. C. For purposes The scope of this CIA, CIA shall be governed by the term following definitions: 1. “Covered Persons” includes: 1. a. all owners of Walgreens and any Walgreens Affiliate Aegerion who are natural persons (other than shareholders who: (ai) have an ownership interest of less than 5% and (bii) acquired the ownership interest through public trading).) and all directors of Aegerion and Novelion Therapeutics Inc.; 2. b. all officers and directors employees of Walgreens; and, Aegerion and all officers and directors of any Walgreens Affiliate who engage in Covered Functions; 3. all employees of Walgreens Novelion Therapeutics Inc. and Novelion Services USA, Inc. who are engaged in or any Walgreens Affiliate who audit or supervise personnel who are engaged in Covered Functions, Functions (as defined below in Section II.D.;II.C.7); and 4. c. all Walgreens and Walgreens Affiliate contractors, subcontractors, agents, and other persons, excluding the Independent Review Organization, persons (including contract sales personnel) who audit or perform any of the Covered FunctionsFunctions on behalf of Aegerion, and in that capacity either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), Payors (as defined below in Section II.C.6) or consumers; or (ii) perform activities, provide services, or create materials relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by an Aegerion employee who is a Covered Person prior to execution or dissemination. Notwithstanding the above, the term “Covered Persons” Persons does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work for Walgreens or any Walgreens Affiliate more than 160 hours during a Reporting Period Period, except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours for Walgreens or a Walgreens Affiliate during a the Reporting Period.

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Walgreens Endo under this CIA shall be five years from the effective date Effective Date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.” B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s =s receipt of: (1) Walgreens’ EPI’s final Annual Report Report; or (2) any additional materials submitted by Walgreens EPI pursuant to OIG’s =s request, whichever is later. C. For purposes The scope of this CIA, CIA shall be governed by the term following definitions: 1. “Covered Persons” includes: 1. a. all directors of Endo Health Solutions Inc. (or any future parent company of Endo) (hereafter referred to as “EHS”) and Endo, and all owners of Walgreens EHS and any Walgreens Affiliate Endo who are natural persons (other than shareholders who: (ai) have an ownership interest of less than 5% and (bii) acquired the ownership interest through public tradingtrading or in connection with the operation of employee incentive programs).; 2. b. all officers and directors of Walgreens; and, all officers and directors of any Walgreens Affiliate who engage in Covered FunctionsEHS with responsibilities for Endo activities; 3. c. all employees of Walgreens or any Walgreens Affiliate EPI; d. all employees of ▇▇▇▇ who audit or are engaged in or have job responsibilities relating to any of the Covered Functions, Functions (as defined below in Section II.D.;II.C.6); and 4. e. all Walgreens and Walgreens Affiliate contractors, subcontractors, agents, and other persons, excluding the Independent Review Organization, persons who audit or perform any of the Covered FunctionsFunctions on behalf of Endo and in that capacity either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), or consumers (including contract sales personnel); or (ii) perform activities, provide services, or create materials Endo Pharmaceuticals Inc. Corporate Integrity Agreement relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by an Endo employee who is a Covered Person prior to execution or dissemination. Notwithstanding the above, the term “Covered Persons” Persons does not include part-include: 1) part- time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work for Walgreens or any Walgreens Affiliate more than 160 hours during a Reporting Period per year, except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours during the calendar year; or 2) employees of Generics International, Inc. (US Parent) and its subsidiaries, American Medical Systems Holdings, Inc. and its subsidiaries, or HealthTronics, Inc. and its subsidiaries. The products of Generics International (US Parent), Inc. and its subsidiaries, American Medical Systems Holdings, Inc. and its subsidiaries, and HealthTronics Inc. and its subsidiaries are not considered Government Reimbursed Products (as defined below) for Walgreens or a Walgreens Affiliate during a Reporting Periodpurposes of this CIA.

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Walgreens Spectranetics under this CIA shall be five years from the effective date of this CIA, unless otherwise specified. The “Effective Date” effective date shall be the date on which the final signatory of this CIA executes this CIACIA (Effective Date). Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.” B. Sections VII, IX, X, and XI shall expire no later than 120 days after OIG’s =s receipt of: (1) WalgreensSpectranetics’ final Annual Report annual report; or (2) any additional materials submitted by Walgreens Spectranetics pursuant to OIG’s =s request, whichever is later. C. For purposes The scope of this CIA, CIA shall be governed by the term following definitions: 1. “Covered Persons” includes: 1. a. all owners of Walgreens and any Walgreens Affiliate Spectranetics who are natural persons persons, (other than shareholders who: (a1) have an ownership interest of less than 5% %; and (b2) acquired the ownership interest through public trading).; 2. b. all officers and directors of WalgreensSpectranetics; and, all officers U.S.-based employees of Spectranetics; and directors of any Walgreens Affiliate who engage in Covered Functions; 3. all employees of Walgreens or any Walgreens Affiliate Spectranetics who audit or are engaged in Covered Functions, based outside the United States and have responsibilities relating to Promotional and Product Services Related Functions (as defined below in Section II.D.II.C.2) in the U.S., Clinical Investigation Related Functions related to FDA requirements (as defined below in Section II.C.3), or Reporting Related Functions (as defined below in Section II.C.4); 4. c. all Walgreens and Walgreens Affiliate contractors, subcontractors, agents, and other personspersons who perform Promotional and Product Services Related Functions (as defined below in Section II.C.2) on behalf of Spectranetics; d. all contractors, excluding the Independent Review Organizationsubcontractors, agents, and other persons who audit or perform any Clinical Investigation Related Functions (as defined below in Section II.C.3) on behalf of the Covered FunctionsSpectranetics and e. all contractors, subcontractors, agents, and other persons who perform Reporting Related Functions (as defined below in Section II.C.4) on behalf of Spectranetics. Spectranetics Corporate Integrity Agreement Notwithstanding the above, the this term “Covered Persons” does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work for Walgreens or any Walgreens Affiliate more than 160 hours during a Reporting Period per year, except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours during the calendar year. 2. “Promotional and Product Services Related Functions” includes: (a) the selling, detailing, marketing, advertising, and promotion of Spectranetics products; and (b) the preparation and dissemination of materials or information about, or the provision of services relating to, devices that are distributed within the United States. 3. “Clinical Investigation Related Functions” includes organizing, coordinating, administering, providing training for, monitoring, and FDA reporting related to clinical investigations and patient registries as well as all relevant obligations under FDA’s Investigational Device Exemption regulations, 21 C.F.R. Part 812. 4. “Reporting Related Functions” includes identifying, tracking, and gathering information and preparing and submitting reports to the FDA for Walgreens or a Walgreens Affiliate during a Spectranetics devices. This includes reporting of adverse events (including reports required under 21 U.S.C. § 360i and the Medical Device Reporting Period(MDR) regulation at 21 C.F.R. Part 803 and other reporting under FDA requirements, (including those required under 21 C.F.R. § 814.84). 5. “Relevant Promotional and Product Services Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Services Related Functions.

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Walgreens Amgen under this CIA shall be five years from the effective date of this CIA, unless otherwise specified. The “Effective Date” shall be the date on which Amgen is obligated to pay the final signatory of this CIA executes this CIASettlement Amount as set forth in the Settlement Agreement between Amgen and the United States. Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.” B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s =s receipt of: (1) Walgreens’ Amgen’s final Annual Report Report; or (2) any additional materials submitted by Walgreens Amgen pursuant to OIG’s =s request, whichever is later. C. For purposes The scope of this CIA, CIA shall be governed by the term following definitions: 1. “Covered Persons” includes: 1. a. all owners of Walgreens Amgen and any Walgreens Affiliate Amgen USA who are natural persons (other than shareholders who: (ai) have an ownership interest of less than 5% and (bii) acquired the ownership interest through public trading). 2. ; all officers of Amgen and directors of Walgreens; and, all officers and directors of any Walgreens Affiliate who engage in Covered Functions; 3. all employees of Walgreens Amgen USA who: (i) reside within the United States or any Walgreens Affiliate who audit or (ii) are engaged in or have job responsibilities relating to any of the Covered Functions, Functions (as defined below in Section II.D.II.C.8); and all directors of Amgen and Amgen USA; 4. b. all Walgreens employees of Amgen and Walgreens Affiliate Amgen USA who are engaged in or have responsibilities relating to any of the Covered Functions (as defined below in Section II.C.8); and c. all contractors, subcontractors, agents, and other persons, excluding the Independent Review Organization, persons who audit or perform any of the Covered FunctionsFunctions on behalf of Amgen or Amgen USA, and in that capacity either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), Payors (as defined below in Section II.C.7), or consumers; or (ii) Corporate Integrity Agreement Amgen Inc. perform activities, provide services, or create materials relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by an Amgen or Amgen USA employee who is a Covered Person prior to execution or dissemination. Notwithstanding the above, the term “Covered Persons” Persons does not include part-part- time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work for Walgreens or any Walgreens Affiliate more than 160 hours during a Reporting Period per year, except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours for Walgreens or a Walgreens Affiliate during a Reporting Periodthe calendar year.

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Walgreens Shire under this CIA shall be five years from the effective date Effective Date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.” B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s =s receipt of: (1) Walgreens’ Shire’s final Annual Report (as defined below in Section V); or (2) any additional materials submitted by Walgreens Shire pursuant to OIG’s =s request, whichever is later. C. For purposes The scope of this CIA, CIA shall be governed by the term following definitions: 1. “Covered Persons” includes: 1. a. all owners of Walgreens and any Walgreens Affiliate Shire plc or Shire (as defined above) who are natural persons (other than shareholders who: (ai) have an ownership interest of less than 5% and (bii) acquired the ownership interest through public trading). 2. all officers and directors of Walgreens; and, all officers and directors of any Walgreens Affiliate who engage in Covered Functions; 3. b. all officers, directors, and employees of Walgreens Shire plc or any Walgreens Affiliate Shire who audit or are engaged in or have job responsibilities relating to any of the Covered Functions, Functions (as defined below in Section II.D.;II.C.7); and 4. c. all Walgreens and Walgreens Affiliate contractors, subcontractors, agents, and other persons, excluding the Independent Review Organization, persons who audit or perform any of the Covered FunctionsFunctions on behalf of Shire plc, or Shire and in that capacity either: (i) interact directly with health care professionals (HCPs), health care institutions (HCIs), Payors (as defined below in Section II.C.6), or consumers; or (ii) perform activities, provide services, or create materials relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by a Shire plc or Shire employee who is a Covered Person prior to execution or dissemination. Shire North American Group, Inc. Corporate Integrity Agreement Notwithstanding the above, the term “Covered Persons” Persons does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work for Walgreens or any Walgreens Affiliate more than 160 hours during a Reporting Period per year, except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours for Walgreens or a Walgreens Affiliate during a Reporting Periodthe calendar year.

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Walgreens SUN under this CIA shall be five years from the effective date of this CIA. The “Effective Date” shall be the date on which the final signatory of this CIA executes this CIA. Each one-year 1 Excluding Eager Park Pharmacy and Health Services, LLC and the following entities that do business as Alliance Rx Walgreens Prime: Walgreens Specialty Pharmacy, LLC; Cystic Fibrosis Services, LLC; Prime Therapeutics Specialty Pharmacy LLC; and Walgreens Mail Service, LLC. Walgreen Co. - Corporate Integrity Agreement period, beginning with the one-year period following the Effective Date, shall be referred to as a “Reporting Period.”” SUN Corporate Integrity Agreement B. Sections VII, X, and XI shall expire no later than 120 days after OIG’s receipt of: (1) Walgreens’ SUN’s final Annual Report Report; or (2) any additional materials submitted by Walgreens SUN pursuant to OIG’s request, whichever is later. C. The scope of this CIA is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: 1. : (a) all owners of Walgreens and any Walgreens Affiliate SUN who are natural persons (other than shareholders who: (ai) have an ownership interest of less than 5% and (bii) acquired the ownership interest through public trading). 2. ) and all officers and directors of WalgreensSUN; and, all officers and directors of any Walgreens Affiliate who engage in Covered Functions; 3. (b) all employees of Walgreens SUN who are engaged in or any Walgreens Affiliate who audit or supervise personnel who are engaged in Covered Functions, Functions (as defined below in Section II.D.; 4. II.C.6); and (c) all Walgreens and Walgreens Affiliate contractors, subcontractors, agents, and other persons, excluding the Independent Review Organization, persons who audit or perform any of the Covered Functions on behalf of SUN and who, in the course of performing Covered Functions, either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), or consumers; or (ii) perform activities, provide services, or create materials relating to the Covered Functions and those activities, services, or materials are not reviewed or supervised by a SUN employee who is a Covered Person prior to execution or dissemination. Notwithstanding the above, the term “Covered Persons” does not include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work perform a Covered Function for Walgreens or any Walgreens Affiliate SUN more than 160 hours during a Reporting Period per year, except that any such individuals individual shall become a “Covered PersonsPerson” at the point when they work more than 160 hours on a Covered Function for Walgreens or a Walgreens Affiliate SUN during a Reporting Periodthe calendar year.