Common use of Compliance Officer Clause in Contracts

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.

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.

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.

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.

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.

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

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.

Compliance Officer. Prior Since prior to the Effective Date, GSK appointed Xxxxxxx has had in place an individual to serve as Vice President and Compliance Officer for its North America Pharma division (Chief Compliance Officer). GSK Xxxxxxx 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, Xxxxxxx; 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 Xxxxxxx. 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 Xxxxxxx 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.

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.

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.

Compliance Officer. Prior to Within 90 days after the Effective Date, GSK appointed an individual Medicus 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 Federal health GlaxoSmithKline LLC Corporate Integrity Agreement care program and FDA requirements. The Compliance Officer shall be a member of senior management of GSKMedicus, 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 Medicus, 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 Medicus, 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- to-day compliance activities engaged in by GSK Medicus 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 Medicus 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.