Compliance Officer. Prior to the Effective Date, GSK appointed an individual to serve as Vice President and Compliance Officer for its North America Pharma division (Compliance Officer). GSK shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), and shall be authorized to report on such matters to the Board at any time. The Compliance Officer shall not be or be subordinate to the General Counsel or Chief Financial Officer. The Compliance Officer shall be responsible for monitoring the day- to-day compliance activities engaged in by GSK as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK shall report to OIG, in writing, any change in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 4 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual Extendicare shall appoint a Covered Person to serve as Vice President and its Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with CIA, Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program requirements, and FDA requirementsprofessionally recognized standards of care. The Compliance Officer shall also be responsible for monitoring the day-to-day compliance activities engaged in by Extendicare and any reporting obligations created under this CIA. The Compliance Officer shall ensure that Extendicare adopts procedures and systems intended to identify and correct quality of care issues. The Compliance Officer must have sufficient compliance and quality assurance experience to effectively oversee the implementation of the requirements of this CIA. The Compliance Officer shall be a member of senior management of GSKExtendicare, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer Extendicare, shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)Directors of Extendicare, and shall be authorized to report on such matters to the Board of Directors at any time. Written documentation of the Compliance Officer’s reports to the Board of Directors shall be made available to OIG upon request. The Compliance Officer shall not be or be subordinate to the General Counsel or Counsel, Chief Financial Officer. The Compliance , or Chief Operating Officer shall be responsible or have any responsibilities that involve acting in any capacity as legal counsel or supervised legal counsel functions for monitoring the day- to-day compliance activities engaged in by GSK as well as for any reporting obligations created under this CIAExtendicare. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Extendicare shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 3 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement
Compliance Officer. Prior a. OMIG shall have the right to the Effective Date, GSK appointed an individual to serve as Vice President and approve or disapprove Provider’s appointment of its Compliance Officer for its North America Pharma division (Compliance Officer). GSK shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, and any subsequent appointment to the Compliance Officer position. OMIG’s approval or disapproval shall be authorized to oversee compliance with Federal health care program based on the appointee’s or incumbent’s independence and FDA requirements and with the requirements of this CIA. The Compliance Officer isobjectivity, and shall continue qualifications to be, responsible for developing perform the functions and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth duties described in Section IV of this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK18 NYCRR 521.3, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), and shall be authorized to report on such matters to the Board at any time. The Compliance Officer shall not be or be subordinate to the General Counsel or Chief Financial Officer. The Compliance Officer shall be responsible for monitoring the day- to-day compliance activities engaged in by GSK as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK applicable.
b. Provider shall report to OIGOMIG and to the IRO, in writing, any change or anticipated change in the identity or position description of the Compliance Officer, or any actions action or changes change or anticipated change that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five 5 business days after of such a change or identified anticipated change, whichever is sooner.
c. Provider shall report to OMIG and to the IRO, in writing, any vacancy or anticipated vacancy in the Compliance Officer position within five business days of the vacancy or anticipated vacancy, whichever is sooner. The report shall include a statement of the reason for the vacancy, the expected duration of the vacancy and the plan that the Provider will implement to fill the vacancy. The Provider shall also provide updates to OMIG and the IRO in writing on the status of the Provider’s effort to fill the vacancy every thirty calendar days until the vacancy in the Compliance Officer position is filled.
d. The Provider shall provide OMIG with the Compliance Officer’s name, contact information, non-compliance related duties for the Provider, compliance related work history and the Compliance Officer’s resume. The Provider shall provide the information referenced in this paragraph to OMIG and the IRO at the time of the initial appointment of the Compliance Officer and at any time that the Compliance Officer’s compliance or non-compliance related duties change.
e. The Compliance Officer shall meet periodically, but no less frequently than quarterly, with the Board to report on the activities of the Compliance Program and the performance of the Provider’s and Compliance Officer’s obligations under the terms of the CIA.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual CCH shall appoint a Covered Person to serve as Vice President and its Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized a member of senior management of CCH, shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of CCH, and FDA requirements and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for CCH. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board Governing Authority of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)CCH, and shall be authorized to report on such matters to the Board Governing Authority at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Governing Authority shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK CCH as well as for fulfilling any reporting obligations created under this CIA. As part of his or her monitoring function, the Compliance Officer shall make visits to each CCH branch office at least once annually and more frequently, as appropriate. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK CCH shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement (Amedisys Inc), Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and UHS shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized must have sufficient compliance and quality assurance experience to effectively oversee compliance with Federal health care program and FDA requirements and with the implementation of the requirements of this CIA. The Compliance Officer isshall be an employee and a member of senior management of UHS, shall report directly to the President of UHS, Inc., and shall continue not be or be subordinate to bethe General Counsel, Chief Financial Officer, or Chief Operating Officer, or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for UHS. The Compliance Officer shall be responsible for for, without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA CIA, and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Audit Committee of the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)UHS, and shall be authorized to report on such matters to the Audit Committee of the Board of UHS at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Audit Committee of the Board of UHS shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK as well as for UHS and any reporting obligations created under this CIA, and ensuring that UHS is appropriately identifying and correcting quality of care problems. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK UHS shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement (Universal Health Services Inc), Corporate Integrity Agreement
Compliance Officer. Prior to Exactech has appointed, and shall maintain during the Effective Dateterm of the CIA, GSK appointed an individual to serve as Vice President its Compliance Officer. To the extent necessary, within 120 days after the Effective Date, Exactech shall modify the position description, scope of responsibility, and authority of the Compliance Officer for its North America Pharma division (Compliance Officer)such that the following requirements are satisfied. GSK shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSKExactech, and shall report directly to the Senior Vice President for GovernanceNominating, Ethics, Compliance and Assurance Governance Committee of GlaxoSmithKline PLC who, in turn, reports the Board of Directors and indirectly to the Chief Executive Officer of GlaxoSmithKline PLCPresident and CEO. The Compliance Officer shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)Directors of Exactech, and shall be authorized to report on such matters to the Board of Directors at any time. The Compliance Officer shall not be or be subordinate to the General Counsel or Chief Financial Officer. The Compliance Officer shall be responsible for monitoring the day- day-to-day compliance activities engaged in by GSK Exactech as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Exactech shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement (Exactech Inc)
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual Good Shepherd shall appoint a Covered Person to serve as Vice President and its Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized a member of senior management of Good Shepherd, shall report directly to oversee compliance with Federal health care program the President of Good Shepherd, and FDA requirements and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Good Shepherd. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters in person directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)Directors of Good Shepherd, and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK Good Shepherd as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Good Shepherd shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Compliance Officer. Prior to To the extent not already accomplished, within 90 days after the Effective Date, GSK appointed KDMC shall appoint an individual to serve as Vice President and its Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSKKDMC, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer KDMC, shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)Directors of KDMC, and shall be authorized to report on such matters to the Board of Directors at any time. Written documentation of the Compliance Officer’s reports to the Board of Directors shall be made available to OIG upon request. The Compliance Officer shall not be or be subordinate to the General Counsel or Chief Financial OfficerOfficer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for KDMC. The Compliance Officer shall be responsible for monitoring the day- day-to-day compliance activities engaged in by GSK KDMC as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK KDMC shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed the Friendship Entities shall appoint an individual employee to serve as Vice President and their Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized a member of senior management of the Friendship Entities, shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of the Friendship Entities, and FDA requirements and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for the Friendship Entities. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “Directors of the Board”)Friendship Entities, and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK the Friendship Entities as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK The Friendship Entities shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 2 contracts
Samples: Corporate Integrity Agreement, Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and Providence shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized must have sufficient compliance and quality assurance experience to effectively oversee compliance with Federal health care program and FDA requirements and with the implementation of the requirements of this CIA. The Compliance Officer isshall be an employee and a member of senior management of Providence, shall report directly to the Chief Executive Officer of Providence, and shall continue not be or be subordinate to bethe General Counsel, Chief Financial Officer, or Chief Operating Officer, or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Providence. The Compliance Officer shall be responsible for for, without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make requirements;
b. making periodic (at least quarterly) reports regarding compliance matters directly in person to the Board of GlaxoSmithKline PLC Directors of Providence (Board), or any authorized committee thereof (hereinafter, “the Board”)Board CIA Committee, and shall be authorized to report on such matters to the Board or Board CIA Committee at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel Board or Chief Financial Officer. The Compliance Officer Board CIA Committee shall be responsible for monitoring made available to OIG upon request; and
c. Monitoring the day- day-to-day compliance activities engaged in by GSK as well as for Providence and any reporting obligations requirements created under this CIA. , and ensuring that Providence is appropriately identifying and correcting quality of care problems. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Providence shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations requirements in this CIA, within five business days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and Healthquest, Inc. shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIAIA. During the term of this CIA, the The Compliance Officer shall be authorized an employee and a member of senior management of Healthquest, Inc., shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of Healthquest, Inc., and FDA requirements and with shall not be or be subordinate to the requirements of this CIA. General Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Healthquest, Inc.. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA IA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board Chief Executive Officer of GlaxoSmithKline PLC or any authorized committee thereof (hereinafterHealthquest, “the Board”), Inc. and shall be authorized to report on such matters to the Board Chief Executive Officer at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Executive Officer shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK Healthquest, Inc. as well as for any reporting obligations created under this CIAIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIAIA. GSK Healthquest, Inc. shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIAIA, within five days after such a change.
Appears in 1 contract
Samples: Integrity Agreement
Compliance Officer. Prior to Maxim has appointed, and shall maintain during the Effective Dateterm of the CIA, GSK appointed an individual to serve as Vice President and Compliance Officer for its North America Pharma division (Compliance Officer). GSK shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSKMaxim, and shall report directly to the Senior Vice President for Governance, Ethics, Board of Directors and Assurance of GlaxoSmithKline PLC who, in turn, reports indirectly to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer Maxim, and shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), Directors and shall be authorized to report on such matters to the Board of Directors at any time. The Compliance Officer shall not be or be subordinate to the General Counsel or Counsel, Chief Financial Officer, or any sales or clinical officers. The Compliance Officer shall be responsible for monitoring the day- day-to-day compliance activities engaged in by GSK Maxim as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Maxim shall not assert a privilege to the OIG with respect to legal advice or counsel Maxim obtains after the Effective Date and during the term of the CIA from the Compliance Officer or any employee reporting to the Compliance Officer regarding (a) Federal health care programs, statutes, and regulations, or (b) compliance with the terms of this CIA. The Compliance Officer or any employee reporting to the Compliance Officer may seek legal advice from internal or external attorneys outside the Compliance Department without waiving any applicable privilege. Maxim shall report to OIG, in writing, any change in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a the change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and shall appoint a Compliance Officer for its North America Pharma division (OCOM Compliance Officer). GSK ) and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The OCOM Compliance Officer shall be authorized an employee and a member of senior management of the OCOM, shall report directly to oversee compliance with Federal health care program and FDA requirements and with the requirements Chief Executive Officer of this CIA. The Compliance Officer isOCOM, and shall continue not be or be subordinate to bethe General Counsel or OCOM Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for the OCOM. The OCOM Compliance Officer shall be responsible for, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly in person to the Board of GlaxoSmithKline PLC or any authorized committee thereof Managers of OCOM (hereinafter, “the Board”), ) and shall be authorized to report on such matters to the Board at any time. The Written documentation of the OCOM Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK OCOM as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the OCOM Compliance Officer shall be limited and must not interfere with the OCOM Compliance Officer’s ability to perform the duties outlined in this CIA. GSK OCOM shall report to OIG, in writing, any change changes in the identity of the OCOM Compliance Officer, or any actions or changes that would affect the OCOM Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five business days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President APM, Park Center, and Xxxxxx shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized an employee of APM, Park Center, or Xxxxxx and a member of senior management of APM or Park Center, shall report directly to oversee compliance with Federal health care program Xxxxxx as the Principal1 of APM and FDA requirements Park Center, and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for APM, Park Center, or Xxxxxx. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board Principal of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)APM and Park Center, and shall be authorized to report on such matters to the Board Principal at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Principal shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK APM, Park Center, and Xxxxxx as well as for any reporting obligations created under this CIA. 1 If there are ever any additional Principals or owners at APM or Park Center, all requirements set forth in this CIA shall apply to them as well. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK APM, Park Center, and Xxxxxx shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior Since prior to the Effective Date, GSK appointed Daiichi has had in place an individual to serve as Vice President and Compliance Officer for its North America Pharma division (Chief Compliance Officer). GSK Daiichi shall maintain a Compliance Officer for the term of the CIA. During the term of this CIACIA who fulfills, at a minimum, the Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of obligations set forth in this CIA. The Compliance Officer is, is and shall continue to be, be responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer is and shall be remain a member of senior management of GSK, Daiichi; reports and shall continue to report directly to the Senior Vice Executive Chairman and President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer Daiichi; shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), Directors of Daiichi; and shall be authorized to report on such matters to the Board of Directors at any time. Written documentation of the Compliance Officer’s reports to the Board of Directors shall be made available to OIG upon request. The Compliance Officer is not and shall not be be, or be subordinate to to, the General Counsel or Chief Financial OfficerOfficer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Daiichi. The Compliance Officer is and shall be remain responsible for monitoring the day- day-to-day compliance activities engaged in by GSK Daiichi as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer unrelated to compliance shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Daiichi shall report to OIG, in writing, any change in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to the Effective Date, GSK appointed an individual to serve as Vice President and a Compliance Officer for its North America Pharma division GMS business unit (GMS Compliance Officer). ) and GSK shall maintain a GMS Compliance Officer for the term of the CIAthis Appendix. During the term of this CIA, the The GMS Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing overseeing the development and implementing implementation of policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and Appendix relating to cGMP Activities, with applicable Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program requirements and applicable FDA requirements. The GMS Compliance Officer shall be a member of senior management of GSKGMS, and shall report directly to the Senior Vice President for Governance, Ethics, Ethics and Assurance of GlaxoSmithKline PLC PLC, who, in turn, turn reports to the Chief Executive Officer of GlaxoSmithKline PLC. The GMS Compliance Officer shall make periodic (at least quarterly) reports regarding GMS compliance matters directly related to this Appendix to the Board of Directors (or an authorized committee thereof) of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), and shall be authorized to report on such matters to the Board at any time. The GMS Compliance Officer shall not be or be subordinate to the General Counsel or Chief Financial Officer. The GMS Compliance Officer shall be responsible for monitoring oversight of the day- day-to-day compliance activities engaged in by GSK GMS as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the GMS Compliance Officer shall be limited and must not interfere with the GMS Compliance Officer’s ability to perform the duties outlined in this CIA. GSK shall report to OIG, in writing, any change changes in the identity of the GMS Compliance Officer, or any actions or changes that would affect the GMS Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIAAppendix, within five 5 days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and Vascular Access Centers shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized an employee and a member of senior management of Vascular Access Centers, shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of Vascular Access Centers, and FDA requirements and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Vascular Access Centers. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make requirements;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board General Partners of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), Vascular Access Centers and shall be authorized to report on such matters to the Board General Partners at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Partners shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK Vascular Access Centers as well as for any reporting obligations created under this CIA. CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Vascular Access Centers shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Within 120 days after the Effective Date, GSK appointed an individual PharMerica shall appoint a Covered Person to serve as Vice President and its Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized a member of senior management of PharMerica, shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of PharMerica, and FDA requirements and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for PharMerica. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA Controlled Substances Act requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)Directors of PharMerica, and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request;
c. monitoring the day- day-to-day compliance activities engaged in by GSK PharMerica as well as for any reporting obligations created under this CIA; and
d. ensuring that one or more members of the Compliance Department (including the Chief Compliance Officer) visits each PharMerica location that fills prescriptions for Controlled Substances at least once every 36 months; and
e. coordinating ongoing field-based compliance activities with local pharmacy staff and regional managers. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK PharMerica shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Xxxxxxx has an appointed Compliance Officer. Within 120 days after the Effective Date, GSK appointed an individual Baptist shall report to serve OIG the identity of the Covered Person serving as Vice President and its Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSKBaptist, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer Baptist, shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)Directors of Baptist, and shall be authorized to report on such matters to the Board of Directors at any time. Written documentation of the Compliance Officer’s reports to the Board of Directors shall be made available to OIG upon request. The Compliance Officer shall not be or be subordinate to the General Counsel or Chief Financial OfficerOfficer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Baptist. The Compliance Officer shall be responsible for monitoring the day- day-to-day compliance activities engaged in by GSK Baptist as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Xxxxxxx shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to the Effective Date, GSK appointed an individual to serve as Vice President and Amedisys has a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, be responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall continue to be a member of senior management of GSKAmedisys, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer Amedisys, shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC Directors of Amedisys (or any authorized committee thereof (hereinafter, “a Committee of the Board”), and shall be authorized to report on such matters to the Board of Directors at any time. Written documentation of the Compliance Officer’s reports to the Board of Directors shall be made available to OIG upon request. The Compliance Officer shall not be or be subordinate to the General Counsel or Chief Financial Officer. The Compliance Officer shall be responsible for monitoring the day- day-to-day compliance activities engaged in by GSK Amedisys as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Amedisys shall report to OIG, in writing, any change in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.. Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement
Appears in 1 contract
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and Northwest ENT shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIAIA. During the term of this CIA, the The Compliance Officer shall be authorized an employee and a member of senior management of Northwest ENT, shall report directly to oversee compliance with Federal health care program the Board of Directors of Northwest ENT, and FDA requirements and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Northwest ENT. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA IA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make requirements;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), Directors of Northwest ENT and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer's reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK Northwest ENT as well as for any reporting obligations created under this CIA. IA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s 's ability to perform the duties outlined in this CIAIA. GSK Northwest ENT shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s 's ability to perform the duties necessary to meet the obligations in this CIAIA, within five days after such a change.
Appears in 1 contract
Samples: Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed Aegerion shall appoint an individual to serve as its Vice President Ethics and Compliance Officer for its North America Pharma division (Compliance Officer). GSK Aegerion shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized to oversee compliance with Federal health care program and FDA requirements and with the requirements of this CIA. The Compliance Officer is, and shall continue to be, responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be an employee and a member of senior management of GSK, Aegerion and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC Aegerion. The Compliance Officer shall also report to the Global Chief Compliance Officer who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. Novelion Therapeutics Inc. The Compliance Officer shall make periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC Directors of Novelion Therapeutics Inc. or any authorized a committee thereof (hereinafter, hereafter “the Board”), ) and shall be authorized to report on such matters to the Board at any time. Written documentation of the Compliance Officer’s reports to the Board shall be made available to OIG upon request. The Compliance Officer shall not be be, or be subordinate to to, the General Counsel or the Chief Financial Officerand Administration Officer of Novelion Therapeutics Inc. or the Vice President Corporate Counsel of Aegerion. The Compliance Officer shall not have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Aegerion, Novelion Therapeutics Inc., or Novelion Services USA, Inc. The Compliance Officer shall be responsible for monitoring the day- day-to-day compliance activities engaged in by GSK Aegerion as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer unrelated to compliance shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Aegerion shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, Officer or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement (Novelion Therapeutics Inc.)
Compliance Officer. Prior to To the extent not already accomplished, within 90 days after the Effective Date, GSK appointed an individual IHS shall appoint a Covered Person to serve as Vice President and its Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized a member of senior management of IHS, shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of IHS, and FDA requirements and with shall not be or be subordinate to the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for IHS. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”)Directors of IHS, and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request;
c. monitoring the day- day-to-day compliance activities engaged in by GSK IHS as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK IHS shall report to OIG, in writing, any change changes in the identity or position description of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and ResMed shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized an employee and a member of senior management of ResMed, shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of ResMed, Inc. and FDA requirements to the Compliance Oversight Committee of ResMed, Inc’s Board of Directors (Compliance Oversight Committee) and with shall not be or be subordinate to the requirements of this CIAResMed General Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for ResMed. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), Compliance Oversight Committee and shall be authorized to report on such matters to the Board Compliance Oversight Committee at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Oversight Committee shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK ResMed as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK ResMed shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five business days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to the Effective Date, GSK appointed an individual to serve as Vice President EAP and Compliance Officer for its North America Pharma division (Compliance Officer). GSK GMLC shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the CIA.1 The Compliance Officer shall be authorized an employee and a member of senior management of ChanceLight, shall report jointly and directly to oversee compliance with Federal health care program the President of Ray Beyond Behavioral Corp. and FDA requirements the Chief Executive Officer of ChanceLight, and with shall not be or be subordinate to the requirements of General Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal 1 Nothing in this CIAAmendment shall be construed to either require or prohibit EAP and GMLC from designating a single individual to serve as the Compliance Officer for both EAP and GMLC. counsel functions for Ray Beyond Behavioral Corp., ChanceLight, EAP, or GMLC. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), Directors of EAP and GMLC and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK EAP and GMLC as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK EAP and GMLC shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and United Therapeutics shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized an employee and a member of senior management of United Therapeutics; shall report directly to oversee compliance with Federal health care program the President of United Therapeutics; and FDA requirements and with shall not be, or be subordinate to, the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for United Therapeutics. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof (hereinafter, “the Board”), Directors of United Therapeutics and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK United Therapeutics as well as for any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK United Therapeutics shall report to OIG, in writing, any change in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement (UNITED THERAPEUTICS Corp)
Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual to serve as Vice President and Mallinckrodt shall appoint a Compliance Officer for its North America Pharma division (Compliance Officer). GSK and shall maintain a Compliance Officer for the term of the CIA. During the term of this CIA, the The Compliance Officer shall be authorized an employee and a member of senior management of Mallinckrodt; shall report directly to oversee compliance with Federal health care program the Chief Executive Officer of Mallinckrodt; and FDA requirements and with shall not be, or be subordinate to, the requirements of this CIAGeneral Counsel or Chief Financial Officer or have any responsibilities that involve acting in any capacity as legal counsel or supervising legal counsel functions for Mallinckrodt. The Compliance Officer isshall be responsible for, and shall continue to be, responsible for without limitation:
a. developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements set forth in this CIA and with Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSK, and shall report directly to the Senior Vice President for Governance, Ethics, and Assurance of GlaxoSmithKline PLC who, in turn, reports to the Chief Executive Officer of GlaxoSmithKline PLC. The Compliance Officer shall make ;
b. making periodic (at least quarterly) reports regarding compliance matters directly to the Board of GlaxoSmithKline PLC or any authorized committee thereof Directors of Mallinckrodt (hereinafter, “the Board”), ) and shall be authorized to report on such matters to the Board of Directors at any time. The Written documentation of the Compliance Officer shall not be or be subordinate Officer’s reports to the General Counsel or Chief Financial Officer. The Compliance Officer Board of Directors shall be responsible for made available to OIG upon request; and
c. monitoring the day- day-to-day compliance activities engaged in by GSK as well as for Mallinckrodt and any reporting obligations created under this CIA. Any noncompliance job responsibilities of the Compliance Officer shall be limited and must not interfere with the Compliance Officer’s ability to perform the duties outlined in this CIA. GSK Mallinckrodt shall report to OIG, in writing, any change changes in the identity of the Compliance Officer, or any actions or changes that would affect the Compliance Officer’s ability to perform the duties necessary to meet the obligations in this CIA, within five business days after such a change.
Appears in 1 contract
Samples: Corporate Integrity Agreement