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 Forest 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 the final signatory of this CIA executes the document (Effective Date). Each one-year 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 receipt of: (1) Forest’s final Annual Report; or (2) any additional materials submitted by Forest 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 Forest who are natural persons (other than shareholders who (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading); b. all directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, (1) all U.S.-based officers, directors, and employees of Forest, and (2) all officers, directors, and employees of Forest who are based outside the United States and who have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions; and d. except as carved out below in this Section II.C.1, all contractors, subcontractors, agents, and other persons who perform Promotional and Product Related Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of Forest. Notwithstanding the above, the term “Covered Persons” does not include: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours 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 (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Forest Laboratories Inc)

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TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest Shire 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 the document (Effective Date)this CIA. Each one-year 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) ForestShire’s final Annual ReportReport (as defined below in Section V); or (2) any additional materials submitted by Forest Shire pursuant to OIG’s =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 Forest Shire plc or Shire (as defined above) who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading); b. all directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, (1) all U.S.-based officers, directors, and employees of Forest, and (2) all officers, directors, and employees of Forest Shire plc or Shire who are based outside the United States and who engaged in or have job responsibilities relating to Promotional and Product Related any of the Covered Functions or Regulatory Related Functions(as defined below in Section II.C.7); and d. except as carved out below in this Section II.C.1, c. all contractors, subcontractors, agents, and other persons who perform Promotional any of the Covered Functions on behalf of Shire plc, or Shire and Product Related Functions or Regulatory Related Functions in that capacity either: (i) interact directly with health care professionals (HCPs), health care institutions (HCIs), Payors (as defined below in Section II.C.4II.C.6), or consumers; or (ii) on behalf of Forestperform 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: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours 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 (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest RMS under this CIA shall be five years from the Effective Date 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 the document (Effective Date)this CIA. Each one-year 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 receipt of: (1) ForestRMS’s final Annual Report; or (2) any additional materials submitted by Forest RMS pursuant to OIG’s request, whichever is later. C. The scope of this CIA shall be is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: a. : (a) all owners of Forest RMS who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading); b. trading or private placement) and all officers and directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, RMS; (1b) all U.S.-based officers, directors, and employees of Forest, RMS ; and (2c) all officers, directors, and employees of Forest who are based outside the United States and who have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions; and d. except as carved out below in this Section II.C.1, all contractors, subcontractors, agents, and other persons who perform Promotional and Product Related any of the Covered Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of ForestRMS, and in that capacity either: (i) interact directly with healthcare professionals (HCPs) and healthcare institutions (HCIs); 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 RMS employee who is a Covered Person prior to execution or dissemination. Notwithstanding Nothwistanding the above, the term Covered Persons” Person does not include: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) include part-time or per per-diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours 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 (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Ra Medical Systems, Inc.)

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest Aegerion under this CIA shall be five years from the Effective Date 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 the document (Effective Date)this CIA. Each one-year 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) ForestAegerion’s final Annual Report; or (2) any additional materials submitted by Forest Aegerion pursuant to OIG’s =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 Forest Aegerion who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading)) and all directors of Aegerion and Novelion Therapeutics Inc.; b. all directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, (1) all U.S.-based officers, directors, officers and employees of Forest, Aegerion and (2) all officers, directors, officers and employees of Forest Novelion Therapeutics Inc. and Novelion Services USA, Inc. who are based outside the United States and engaged in or who have responsibilities relating to Promotional and Product Related supervise personnel who are engaged in Covered Functions or Regulatory Related Functions(as defined below in Section II.C.7); and d. except as carved out below in this Section II.C.1, c. all contractors, subcontractors, agents, and other persons (including contract sales personnel) who perform Promotional any of the Covered Functions on behalf of Aegerion, and Product Related Functions or Regulatory Related Functions in that capacity either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), Payors (as defined below in Section II.C.4II.C.6) on behalf of Forestor 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: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours per yearduring a Reporting Period, except that any such individuals shall become “Covered Persons” at the point when they work more than 160 hours during the calendar year; or (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related FunctionsReporting Period. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest ACell under this CIA shall be five years from the Effective Date 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 the document (Effective Date)this CIA. Each one-year 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 receipt of: (1) ForestACell’s final Annual Report; or (2) any additional materials submitted by Forest ACell pursuant to OIG’s request, whichever is later.later.‌ C. The scope of this CIA shall be is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: a. (a) all owners of Forest ACell who are natural persons (other than shareholders who (i) have an ownership interest of less more than 5% and are engaged in Covered Functions;‌ (ii) acquired the ownership interest through public trading); b. all directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, (1) all U.S.-based officers, directors, and employees of Forest, and (2b) all officers, directors, directors and employees of Forest who are based outside the United States and who have responsibilities relating to Promotional and Product Related Functions or Regulatory Related FunctionsACell; andand‌ d. except as carved out below in this Section II.C.1, (c) all contractors, subcontractors, agents, and other persons who perform Promotional and Product Related any of the Covered Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of Forest. ACell and in that capacity 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 ACell employee who is a Covered Person prior to execution or dissemination.‌ Notwithstanding the above, the term Covered Persons” Persons does not include: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours per yearduring a Reporting Period, except that any such individuals shall become Covered Persons” Persons at the point when they work more than 160 hours during the calendar year; or (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related FunctionsReporting Period. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest RMS under this CIA shall be five years from the Effective Date 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 the document (Effective Date)this CIA. Each one-year 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 receipt of: (1) ForestRMS’s final Annual Report; or (2) any additional materials submitted by Forest RMS pursuant to OIG’s request, whichever is later.later.‌ C. The scope of this CIA shall be is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: a. : (a) all owners of Forest RMS who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading); b. trading or private placement) and all officers and directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, RMS; (1b) all U.S.-based officers, directors, and employees of Forest, RMS ; and (2c) all officers, directors, and employees of Forest who are based outside the United States and who have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions; and d. except as carved out below in this Section II.C.1, all contractors, subcontractors, agents, and other persons who perform Promotional and Product Related any of the Covered Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of ForestRMS, and in that capacity either: (i) interact directly with healthcare professionals (HCPs) and healthcare institutions (HCIs); 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 RMS employee who is a Covered Person prior to execution or dissemination. Notwithstanding Nothwistanding the above, the term Covered Persons” Person does not include: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) include part-time or per per- diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours 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 (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest Spectranetics under this CIA shall be five years from the Effective Date effective date of this CIA, unless otherwise specified. The effective date shall be the date on which the final signatory of this CIA executes the document this CIA (Effective Date). Each one-year 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) Forest’s Spectranetics’ final Annual Reportannual report; or (2) any additional materials submitted by Forest Spectranetics pursuant to OIG’s =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 Forest Spectranetics who are natural persons persons, (other than shareholders who who: (i1) have an ownership interest of less than 5% %; and (ii2) acquired the ownership interest through public trading); b. all officers and directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, (1) Spectranetics; all U.S.-based officers, directors, and employees of Forest, Spectranetics; and (2) all officers, directors, and employees of Forest Spectranetics who are based outside the United States and who have responsibilities relating to Promotional and Product Services Related Functions or Regulatory Related Functions; and d. except (as carved out defined below in this Section II.C.1II.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); c. all contractors, subcontractors, agents, and other persons who perform Promotional and Product Services Related Functions or Regulatory (as defined below in Section II.C.2) on behalf of Spectranetics; d. all contractors, subcontractors, agents, and other persons who perform Clinical Investigation Related Functions (as defined below in Section II.C.3) on behalf of Spectranetics 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 ForestSpectranetics. Spectranetics Corporate Integrity Agreement Notwithstanding the above, the this term “Covered Persons” does not include: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) include part-time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours 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 (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 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 Spectranetics devices. This includes reporting of adverse events (including reports required under 21 U.S.C. § 360i and the Medical Device Reporting (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 Related Functions or Regulatory Services Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Spectranetics Corp)

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest Amgen under this CIA shall be five years from the Effective Date effective date of this CIA, unless otherwise specified. The effective date “Effective Date” shall be the date on which Amgen is obligated to pay the final signatory of this CIA executes Settlement Amount as set forth in the document (Effective Date)Settlement Agreement between Amgen and the United States. Each one-year 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) ForestAmgen’s final Annual Report; or (2) any additional materials submitted by Forest Amgen pursuant to OIG’s =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 Forest Amgen and Amgen USA who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading); all officers of Amgen and Amgen USA who: (i) reside within the United States or (ii) are engaged in or have job responsibilities relating to any of the Covered Functions (as defined below in Section II.C.8); and all directors of Amgen and Amgen USA; b. all directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, (1) all U.S.-based officers, directors, and employees of Forest, Amgen and (2) all officers, directors, and employees of Forest Amgen USA who are based outside the United States and who engaged in or have responsibilities relating to Promotional and Product Related any of the Covered Functions or Regulatory Related Functions(as defined below in Section II.C.8); and d. except as carved out below in this Section II.C.1, c. all contractors, subcontractors, agents, and other persons who perform Promotional any of the Covered Functions on behalf of Amgen or Amgen USA, and Product Related Functions or Regulatory Related Functions in that capacity either: (i) interact directly with healthcare professionals (HCPs), healthcare institutions (HCIs), Payors (as defined below in Section II.C.4II.C.7), or consumers; or (ii) on behalf of ForestCorporate 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: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) part-include part- time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours 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 (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest Avanir under this CIA shall be five years from the Effective Date 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 the document (Effective Date)this CIA. Each one-year 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 receipt of: (1) ForestAvanir’s final Annual Report; or (2) any additional materials submitted by Forest Avanir pursuant to OIG’s request, whichever is later.later.‌ C. The scope of this CIA shall be is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: a. (a) all owners of Forest Avanir who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading);trading);‌ b. (b) all officers and directors of Forest Laboratories, Inc.;Xxxxxx;‌ c. except as carved out below in this Section II.C.1, (1c) all U.S.-based officers, directors, and employees of Forest, and (2) all officers, directors, and employees of Forest Avanir who engage in or supervise personnel who are based outside the United States and who have responsibilities relating to Promotional and Product Related engaged in Covered Functions or Regulatory Related Functions(as defined in Section II.C.5); andand‌ d. except as carved out below in this Section II.C.1, (d) all contractors, subcontractors, agents, and other persons who perform Promotional and Product Related any of the Covered Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of Forest. Xxxxxx 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: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) 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 Avanir more than 160 hours 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 Avanir during the calendar year; or (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest under this CIA shall be five years from the Effective Date of this CIA, unless otherwise specified. The effective date CIA shall be the date on which the final signatory of this CIA executes this CIA. The term of this CIA shall be five years from the document (Effective Date). Each one-year 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 receipt of: (1) Forest’s Respironics’ final Annual Report; or (2) any additional materials submitted by Forest Respironics pursuant to OIG’s request, whichever is later.later.‌ C. The scope of this CIA shall be is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: a. : (a) all owners of Forest Respironics who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading); b. all directors of Forest Laboratories, Inc.; c. except as carved out below in this Section II.C.1, ; (1) all U.S.-based officers, directors, and employees of Forest, and (2b) all officers, directors, directors and employees of Forest who are based outside the United States Respironics; and who have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions; and d. except as carved out below in this Section II.C.1, (c) all contractors, subcontractors, agents, agents and other persons who furnish patient care items or services, who perform Promotional and Product Related billing or coding functions, or who perform any of the Covered Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of Forest. Respironics excluding vendors whose sole connection with Respironics is selling or otherwise providing medical supplies or equipment to Respironics.‌ Notwithstanding the above, the term “Covered Persons” does not include: include (ia) employeesemployees at Respironics’ manufacturing or distribution centers to the extent such employees do not perform any marketing, contractorsbilling, subcontractors, agents, collections or other personnel sales functions and do not interact with actual or potential source of Forest who perform only building and facilities functions health care business or referrals or (i.e., facilities maintenance, grounds maintenance, and food service functions); (iib) part-part- time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work for Respironics more than 160 hours per year, except that any such individuals individual shall become a “Covered PersonsPerson” at the point when they work more than 160 hours for Respironics during the calendar year; or (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest Endo 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 the document (Effective Date)this CIA. Each one-year 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) ForestEPI’s final Annual Report; or (2) any additional materials submitted by Forest EPI pursuant to OIG’s =s request, whichever is later. C. The scope of this CIA shall be governed by the following definitions: 1. “Covered Persons” includes: 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 Forest EHS and Endo who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public tradingtrading or in connection with the operation of employee incentive programs); b. all directors officers of Forest Laboratories, Inc.EHS with responsibilities for Endo activities; c. except as carved out below in this Section II.C.1, (1) all U.S.-based officers, directors, and employees of Forest, and (2) EPI; d. all officers, directors, and employees of Forest Xxxx who are based outside the United States and who engaged in or have job responsibilities relating to Promotional and Product Related any of the Covered Functions or Regulatory Related Functions(as defined below in Section II.C.6); and d. except as carved out below in this Section II.C.1, e. all contractors, subcontractors, agents, and other persons who perform Promotional and Product Related any of the Covered Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of ForestEndo 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: (i1) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) part-part- time or per diem employees, contractors, subcontractors, agents, and other persons who are not reasonably expected to work more than 160 hours 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 (iii2) employees of Inwood LaboratoriesGenerics International, Inc. or Cerexa(US Parent) and its subsidiaries, American Medical Systems Holdings, Inc. so long 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 they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functionsdefined below) for purposes of this CIA. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest Walgreens under this CIA shall be five years from the Effective Date 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 the document (Effective Date)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, IX, X, and XI shall expire no later than 120 days after OIG’s receipt of: (1) Forest’s Walgreens’ final Annual Report; Report or (2) any additional materials submitted by Forest Walgreens pursuant to OIG’s request, whichever is later. C. The scope For purposes of this CIA shall be governed by CIA, the following definitions: 1. term “Covered Persons” includes: a. 1. all owners of Forest Walgreens and any Walgreens Affiliate who are natural persons (other than shareholders who who: (ia) have an ownership interest of less than 5% and (iib) 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; b. 3. all directors employees of Forest LaboratoriesWalgreens or any Walgreens Affiliate who audit or are engaged in Covered Functions, Inc.as defined below in Section II.D.; c. except as carved out below in this Section II.C.1, (1) 4. all U.S.-based officers, directors, Walgreens and employees of Forest, and (2) all officers, directors, and employees of Forest who are based outside the United States and who have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions; and d. except as carved out below in this Section II.C.1, all Walgreens Affiliate contractors, subcontractors, agents, and other persons persons, excluding the Independent Review Organization, who audit or perform Promotional and Product Related Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf any of Forestthe Covered Functions. Notwithstanding the above, the term “Covered Persons” does not include: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) 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 per year, 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 the calendar year; or (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functionsa Reporting Period. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

TERM AND SCOPE OF THE CIA. A. The period of the compliance obligations assumed by Forest SUN under this CIA shall be five years from the Effective Date 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 the document (Effective Date)this CIA. Each one-year 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, IX, X, and XI shall expire no later than 120 days after OIG’s receipt of: (1) ForestSUN’s final Annual Report; or (2) any additional materials submitted by Forest SUN pursuant to OIG’s request, whichever is later. C. The scope of this CIA shall be is governed by the following definitions: 1. For purposes of this CIA, the term “Covered Persons” includes: a. : (a) all owners of Forest SUN who are natural persons (other than shareholders who who: (i) have an ownership interest of less than 5% and (ii) acquired the ownership interest through public trading); b. ) and all officers and directors of Forest Laboratories, Inc.; c. except SUN; (b) all employees of SUN who are engaged in or who supervise personnel who are engaged in Covered Functions (as carved out defined below in this Section II.C.1, (1) all U.S.-based officers, directors, and employees of Forest, II.C.6); and (2c) all officers, directors, and employees of Forest who are based outside the United States and who have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions; and d. except as carved out below in this Section II.C.1, all contractors, subcontractors, agents, and other persons who perform Promotional and Product Related any of the Covered Functions or Regulatory Related Functions (as defined below in Section II.C.4) on behalf of ForestSUN 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: (i) employees, contractors, subcontractors, agents, or other personnel of Forest who perform only building and facilities functions (i.e., facilities maintenance, grounds maintenance, and food service functions); (ii) 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 SUN more than 160 hours 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 SUN during the calendar year; or (iii) employees of Inwood Laboratories, Inc. or Cerexa, Inc. so long as they do not have responsibilities relating to Promotional and Product Related Functions or Regulatory Related Functions. 2. “Relevant Covered Persons” includes all Covered Persons whose job responsibilities relate to Promotional and Product Related Functions or Regulatory Related Functions.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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