Common use of Management Accountability and Certifications Clause in Contracts

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK officers or employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable business unit is compliant with applicable Federal health care program and FDA requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President, GSK; the heads of the U.S. Pharma commercial business units; Chairman, Research and Development; Vice President, Strategic, Planning and Operations; Senior Vice President, NA Medical Affairs; President, Pharmaceuticals Research and Development; President, Vaccines; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, and, to the extent that a business unit performs Covered Functions and is not covered by the certification of one of the above- listed individuals, such other executives, vice-presidents, and directors of business units as would be necessary to ensure that there is a Certifying Employee from each such business unit. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [department or functional area], an area under my supervision. My job responsibilities include ensuring compliance with regard to the If any Certifying Employee is unable to provide such a conclusion in the certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above and the steps being taken to address the issue(s) identified in the certification.

Appears in 4 contracts

Samples: Corporate Integrity Agreement, Corporate Integrity Agreement, Corporate Integrity Agreement

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Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK BIPI officers or employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable BIPI business unit is compliant with applicable Federal health care program and FDA requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President, GSK; the heads of the U.S. Pharma commercial business units; Chairman, Research President and Development; Vice President, Strategic, Planning and OperationsChief Executive Officer; Senior Vice President, NA Marketing; Senior Vice President, Sales; Senior Vice President, Medicine & Regulatory; Senior Vice President, Clinical Development & Medical Affairs; Vice President, Pharmaceuticals Research and DevelopmentRegulatory Affairs; Senior Vice President, VaccinesManaged Markets; Vice President, Commercial Operations; Vice President, Clinical Operations; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, and, to the extent that a there are organizational changes at BIPI and any new or different business unit performs Covered Functions and is not covered by the certification certifications of one of the above- above-listed individuals, such other executives, vice-presidents, and directors and/or leaders/heads of business units as would be necessary to ensure that there is a Certifying Employee from each such business unit. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [department or functional area], an area under my supervision. My job responsibilities include ensuring compliance with regard to the If any Certifying Employee is unable to provide such a conclusion in the certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above and the steps being taken to address the issue(s) identified in the certification.

Appears in 1 contract

Samples: Corporate Integrity Agreement

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