Common use of OIG INSPECTION, AUDIT, AND REVIEW RIGHTS Clause in Contracts

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy Indivior’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Indivior’s locations for the purpose of verifying and evaluating: (a) Indivior’s compliance with the terms of this CIA and (b) Indivior’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Indivior’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Indivior’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior present.

Appears in 4 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement (Indivior PLC), Corporate Integrity Agreement

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OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorProgenity’s books, records, and other documents and supporting materials and/or materials, and conduct on-site reviews of any of IndiviorProgenity’s locations for the purpose of verifying and evaluating: (a) IndiviorProgenity’s compliance with the terms of this CIA CIA; and (b) IndiviorProgenity’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The Progenity, Inc. Corporate Integrity Agreement documentation described above shall be made available by Indivior Progenity to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorProgenity’s owners, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Progenity shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorProgenity’s owners, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior Progenity present.

Appears in 2 contracts

Samples: Corporate Integrity Agreement (Progenity, Inc.), Corporate Integrity Agreement (Progenity, Inc.)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorAllergan’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorAllergan’s locations for the purpose of verifying and evaluating: (a) IndiviorAllergan’s compliance with the terms of this CIA CIA; and (b) IndiviorAllergan’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Allergan to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorAllergan’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Allergan shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorAllergan’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Allergan present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Allergan Inc)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, Corporate Integrity Agreement WellCare Health Plans, Inc. OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy Indivior’s WellCare's books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorWellCare’s locations for the purpose of verifying and evaluating: (a) IndiviorWellCare’s compliance with the terms of this CIA CIA; and (b) IndiviorWellCare’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms in which it participates. The documentation described above shall be made available by Indivior WellCare to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorWellCare’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior WellCare shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s 's request. Indivior’s owners, employees, contractors and directors WellCare's employees may elect to be interviewed with or without a representative of Indivior WellCare present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Wellcare Health Plans, Inc.)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndivioreTEL-Rx’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndivioreTEL-Rx’s locations for the purpose of verifying and evaluating: (a) IndivioreTEL-Rx’s compliance with the terms of this CIA CIA; and (b) IndivioreTEL-Rx’s compliance with the eTEL-Rx Corporate Integrity Agreement requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms in which it participates. The documentation described above shall be made available by Indivior eTEL-Rx to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndivioreTEL-Rx’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior eTEL-Rx shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndivioreTEL-Rx’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior xXXX-Xx present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of Endo’s or copy IndiviorEHS’s books, records, and other documents and supporting materials and/or conduct on-on- site reviews of any of IndiviorEndo’s locations for the purpose of verifying and evaluating: (a) IndiviorEndo’s and EHS’s compliance with the terms of this CIA CIA; and (b) IndiviorEndo’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Endo and/or EHS to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorEndo’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place Endo Pharmaceuticals Inc. Corporate Integrity Agreement of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Endo shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorEndo’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Endo present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy Indivior’s the Providers’ books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Indivior’s the Providers’ locations for the purpose of verifying and evaluating: (a) Indivior’s the Providers’ compliance with the terms of this CIA IA; and (b) Indivior’s the Providers’ compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior the Providers to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview the Providers and any of Indivior’s owners, the Providers’ employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior The Providers shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Indivior’s owners, employees, contractors and directors The Providers’ employees may elect to be interviewed with or without a representative of Indivior the Providers present.

Appears in 1 contract

Samples: Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorBaxano Surgical’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorBaxano Surgical’s locations for the purpose of verifying and evaluating: (a) IndiviorBaxano Surgical’s compliance with the terms of this CIA CIA; and (b) IndiviorBaxano Surgical’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Baxano Surgical to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorBaxano Surgical’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Baxano Surgical shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorBaxano Surgical’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Baxano Surgical present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Baxano Surgical, Inc.)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy Indivior’s Novartis’ books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Indivior’s Novartis’ locations for the purpose of verifying and evaluating: (a) Indivior’s Novartis’ compliance with the terms of this CIA and (b) Indivior’s Novartis’ compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Novartis to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Indivior’s Novartis’ owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Novartis shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Indivior’s Novartis’ owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior Novartis present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or to copy IndiviorUHS’s books, records, and other documents and supporting materials and/or and conduct on-site reviews of any of IndiviorUHS’s locations for the purpose of verifying and evaluating: (a) IndiviorUHS’s compliance with the terms of this CIA CIA; and (b) IndiviorUHS’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior UHS to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorUHS’s ownersowners who are Covered Persons, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior UHS shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIGXXX’s request. IndiviorUHS’s ownersowners who are Covered Persons, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior UHS present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy Indivior’s Spectranetics’ books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Indivior’s Spectranetics’ locations for the purpose of verifying and evaluating: (a) Indivior’s Spectranetics’ compliance with the terms of this CIA CIA; and (b) Indivior’s Spectranetics’ compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Spectranetics to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Indivior’s owners, Spectranetics’ employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Spectranetics shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Indivior’s owners, employees, contractors and directors Spectranetics’ employees may elect to be interviewed with or without a representative of Indivior Spectranetics present.. Spectranetics Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement (Spectranetics Corp)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorOrthofix’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorOrthofix’s locations for the purpose of verifying and evaluating: (a) IndiviorOrthofix’s compliance with the terms of this CIA CIA; and (b) IndiviorOrthofix’s compliance with the requirements of the Federal health care program requirements programs and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Orthofix to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorOrthofix’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Orthofix shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorXxxxxxxx’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Orthofix present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy Indivior’s Northwest ENT's books, records, and other documents and supporting materials and/or and conduct on-site reviews of any of Indivior’s locations Northwest ENT's locations, for the purpose of verifying and evaluating: (a) Indivior’s Northwest ENT's compliance with the terms of this CIA IA and (b) Indivior’s Northwest ENT's compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior Northwest ENT to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Indivior’s Northwest ENT's owners, employees, and contractors and directors who consent to be interviewed at the individual’s 's place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Northwest ENT shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s 's request. Indivior’s Northwest ENT's owners, employees, and contractors and directors may elect to be interviewed with or without a representative of Indivior Northwest ENT present.

Appears in 1 contract

Samples: Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorRMS’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorRMS’s locations for the purpose of verifying and evaluating: (a) IndiviorRMS’s compliance with the terms of this CIA and (b) IndiviorRMS’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior RMS to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorRMS’s ownersowners (who are Covered Persons), employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior RMS shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorRMS’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior RMS present.

Appears in 1 contract

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

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorPFH’s books, records, and other documents and supporting materials and/or materials, and conduct on-site reviews of any of IndiviorPFH’s locations locations, for the purpose of verifying and evaluating: (a) IndiviorPFH’s compliance with the terms of this CIA and (b) IndiviorPFH’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior PFH to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorPFH’s owners, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior PFH shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorPFH’s owners, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior PFH present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG OIG, or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorInterMune’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorInterMune’s locations for the purpose of verifying and evaluating: (a) IndiviorInterMune’s compliance with the terms of this CIA CIA; and (b) IndiviorInterMune’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior InterMune to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorInterMune’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior InterMune shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorInterMune’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior InterMune present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Intermune Inc)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorProgenity’s books, records, and other documents and supporting materials and/or materials, and conduct on-site reviews of any of IndiviorProgenity’s locations for the purpose of verifying and evaluating: (a) IndiviorProgenity’s compliance with the terms of this CIA CIA; and (b) IndiviorProgenity’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior Progenity to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorProgenity’s owners, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Progenity shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorProgenity’s owners, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior Progenity present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorACell’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorACell’s locations for the purpose of verifying and evaluating: (a) IndiviorACell’s compliance with the terms of this CIA and (b) IndiviorACell’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior ACell to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorACell’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior ACell shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIGXXX’s request. IndiviorACell’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior ACell present.

Appears in 1 contract

Samples: Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorCephalon’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorCephalon’s locations for the purpose of verifying and evaluating: (a) IndiviorCephalon’s compliance with the terms of this CIA CIA; and (b) IndiviorCephalon’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Cephalon to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorCephalon’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Cephalon shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorCephalon’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Cephalon present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Cephalon Inc)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorMerit’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorMerit’s locations for the purpose of verifying and evaluating: (a) IndiviorMerit’s compliance with the terms of this CIA and (b) IndiviorMerit’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Merit to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorMerit’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Merit shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorMerit’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior Merit present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorAstraZeneca’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorAstraZeneca’s locations for the purpose of verifying Corporate Integrity Agreement AstraZeneca and evaluating: (a) IndiviorAstraZeneca’s compliance with the terms of this CIA CIA; and (b) IndiviorAstraZeneca’s compliance with the requirements of the applicable Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior AstraZeneca to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorAstraZeneca’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior AstraZeneca shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorAstraZeneca’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior AstraZeneca present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorDakwa’s and HEAG’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorDakwa and HEAG’s locations for the purpose of verifying and evaluating: (a) IndiviorDakwa and HEAG’s compliance with the terms of this CIA IA and (b) IndiviorDakwa and HEAG’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior Dakwa and HEAG to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview Dakwa and HEAG and any of IndiviorDakwa’s owners, employees, and HEAG’s employees or contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Dakwa and HEAG shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorDakwa and HEAG’s owners, employees, employees and contractors and directors may elect to be interviewed with or without a representative of Indivior present.Dakwa or HEAG present.‌

Appears in 1 contract

Samples: Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. ‌ Corporate Integrity Agreement – USWM In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorUSWM’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorUSWM’s locations for the purpose of verifying and evaluating: (a) IndiviorUSWM’s compliance with the terms of this CIA and (b) IndiviorUSWM’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior USWM to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorUSWM’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior USWM shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorUSWM’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior USWM present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorOrthofix’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorOrthofix’s locations for the purpose of verifying and evaluating: (a) IndiviorOrthofix’s compliance with the terms of this CIA CIA; and (b) IndiviorOrthofix’s compliance with the requirements of the Federal health care program requirements programs and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Orthofix to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorOrthofix’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Orthofix shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorOrthofix’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Orthofix present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Orthofix International N V)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy Indivior’s the Covered Entities’ books, records, and other documents and supporting materials and/or and conduct on-site reviews of any of Indivior’s locations the Covered Entities’ locations, for the purpose of verifying and evaluating: (a) Indivior’s the Covered Entities’ compliance with the terms of this CIA IA and (b) Indivior’s the Covered Entities’ compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior the Covered Entities to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Indivior’s the Covered Entities’ owners, employees, and contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior The Covered Entities shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Indivior’s The Covered Entities’ owners, employees, and contractors and directors may elect to be interviewed with or without a representative of Indivior the Covered Entities present.

Appears in 1 contract

Samples: Integrity Agreement

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OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorRadeas’s books, records, and other documents and supporting materials and/or materials, and conduct on-site reviews of any of IndiviorRadeas’s locations for the purpose of verifying and evaluating: (a) IndiviorRadeas’s compliance with the terms of this CIA CIA; and (b) IndiviorRadeas’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior Radeas to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorRadeas’s owners, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Radeas shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorRadeas’s owners, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior Radeas present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorAvanir’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorAvanir’s locations for the purpose of verifying and evaluating: (a) IndiviorAvanir’s compliance with the terms of this CIA and (b) IndiviorAvanir’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Avanir to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorAvanir’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Avanir shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorAvanir’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior Avanir present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorHealthquest, Inc.’s books, records, and other documents and supporting materials and/or and conduct on-site reviews of any of IndiviorHealthquest, Inc.’s locations locations, for the purpose of verifying and evaluating: (a) IndiviorHealthquest, Inc.’s compliance with the terms of this CIA IA and (b) IndiviorHealthquest, Inc.’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior Healthquest, Inc. to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorHealthquest, Inc.’s owners, employees, and contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Healthquest, Inc. shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorHealthquest, Inc.’s owners, employees, and contractors and directors may elect to be interviewed with or without a representative of Indivior Healthquest, Inc. present.

Appears in 1 contract

Samples: Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorMerit’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorMerit’s locations for the purpose of verifying and evaluating: (a) IndiviorMerit’s compliance with the terms of this CIA and (b) IndiviorMerit’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Merit to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorMerit’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Merit shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorMerit’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior Merit present.. ​ ​ ​ ​ ​ ​ ​ Merit Medical Systems, Inc. CIA ​ ​ ​

Appears in 1 contract

Samples: Corporate Integrity Agreement (Merit Medical Systems Inc)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorAmgen’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorAmgen’s locations for the purpose of verifying and evaluating: (a) IndiviorAmgen’s compliance with the terms of this CIA CIA; and (b) IndiviorAmgen’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Amgen to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorAmgen’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Amgen shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorAmgen’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Amgen present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorEssilor’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorEssilor’s locations for the purpose of verifying and evaluating: (a) IndiviorEssilor’s compliance with the terms of this CIA and (b) IndiviorEssilor’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Essilor to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorEssilor’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Essilor shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorEssilor’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior Essilor present.. Essilor of America, Inc. and Essilor Laboratories of America, Inc. Corporate Integrity Agreement

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorInsys’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorInsys’s locations for the purpose of verifying and evaluating: (a) IndiviorInsys’s compliance with the terms of this CIA and (b) IndiviorInsys’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Insys to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorInsys’s owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Insys shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorInsys’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior Insys present.

Appears in 1 contract

Samples: Corporate Integrity Agreement and Conditional

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorAegerion’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorAegerion’s locations for the purpose of verifying and evaluating: (a) IndiviorAegerion’s compliance with the terms of this CIA CIA; and (b) IndiviorAegerion’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Aegerion to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorAegerion’s owners, employees, contractors and directors Covered Persons who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Aegerion shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorAegerion’s owners, employees, contractors and directors Covered Persons may elect to be interviewed with or without a representative of Indivior Aegerion present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorLCCA’s books, records, and other documents and supporting materials and/or materials, and conduct on-site reviews of any of IndiviorLCCA’s locations locations, for the purpose of verifying and evaluating: (a) IndiviorLCCA’s compliance with the terms of this CIA and (b) IndiviorLCCA’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior LCCA to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorLCCA’s owners, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior LCCA shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorLCCA’s owners, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior LCCA present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorDiversicare’s books, records, and other documents and supporting materials and/or materials, and conduct on-site reviews of any of IndiviorDiversicare’s locations locations, for the purpose of verifying and evaluating: (a) IndiviorDiversicare’s compliance with the terms of this CIA and (b) IndiviorDiversicare’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior Diversicare to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorDiversicare’s owners, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Diversicare shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorDiversicare’s owners, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior Diversicare present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (Diversicare Healthcare Services, Inc.)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy Indivior’s the CareAll Entities’ books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Indivior’s the CareAll Entities’ locations for the purpose of verifying and evaluating: (a) Indivior’s the CareAll Entities’ compliance with the terms of this CIA CIA; and (b) Indivior’s the CareAll Entities’ compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior the CareAll Entities to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Indivior’s owners, the CareAll Entities’ employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior The CareAll Entities shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Indivior’s owners, employees, contractors and directors The CareAll Entities’ employees may elect to be interviewed with or without a representative of Indivior the CareAll Entities present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy Indivior’s United Therapeutics’ books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Indivior’s United Therapeutics’ locations for the purpose of verifying and evaluating: (a) Indivior’s United Therapeutics’ compliance with the terms of this CIA and (b) Indivior’s United Therapeutics’ compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior United Therapeutics to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of Indivior’s United Therapeutics’ owners, employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior United Therapeutics shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Indivior’s United Therapeutics’ owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior United Therapeutics present.

Appears in 1 contract

Samples: Corporate Integrity Agreement (UNITED THERAPEUTICS Corp)

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorEncore’s books, records, and other documents and supporting materials and/or and conduct on-site reviews of any of IndiviorEncore’s locations locations, for the purpose of verifying and evaluating: (a) IndiviorEncore’s compliance with the terms of this CIA and (b) IndiviorEncore’s compliance with the requirements of the Federal health care program requirements and with all applicable FDA requirementsprograms. The documentation described above shall be made available by Indivior Encore to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized Encore Rehabilitation Services, LLC Corporate Integrity Agreement representative(s) may interview any of IndiviorEncore’s owners, employees, contractors contractors, and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Encore shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorEncore’s owners, employees, contractors contractors, and directors may elect to be interviewed with or without a representative of Indivior Encore present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or or request copies of or copy IndiviorShire’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorShire’s locations for the purpose of verifying and evaluating: (a) IndiviorShire’s compliance with the terms of this CIA CIA; and (b) IndiviorShire’s compliance with the requirements of the Federal health care program requirements programs in which it participates and with all applicable FDA requirements. The documentation described above shall be made available by Indivior Shire to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorShire’s owners, employees, contractors and directors contractors, or agents who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior Shire shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. IndiviorShire’s owners, employees, contractors and directors employees may elect to be interviewed with or without a representative of Indivior Shire present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

OIG INSPECTION, AUDIT, AND REVIEW RIGHTS. In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine and/or request copies of or copy IndiviorRMS’s books, records, and other documents and supporting materials and/or conduct on-site reviews of any of IndiviorRMS’s locations for the purpose of verifying and evaluating: (a) IndiviorRMS’s compliance with the terms of this CIA and (b) IndiviorRMS’s compliance with Federal health care program requirements and with all applicable FDA requirements. The documentation described above shall be made available by Indivior RMS to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview any of IndiviorRMS’s ownersowners (who are Covered Persons), employees, contractors and directors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Indivior RMS shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIGXXX’s request. IndiviorRMS’s owners, employees, contractors and directors may elect to be interviewed with or without a representative of Indivior RMS present.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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