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 [insert name of the department or functional area] with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and GSK policies, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [insert name of department or functional area] of GSK is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIA. I understand that this certification is being provided to and relied upon by the United States.” 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.
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain 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, the heads of commercial business units; Vice President, Senior Vice President, and, to the extent that a business unit performs Covered Functions and not covered by the certification of one of above listed individuals, such other executives, vice presidents, and directors of business units as would be necessary to ensure a Certifying Employee from each business unit.
Management Accountability and Certifications. Amedisys shall continue to make compliance a component of each Covered Administrators’ performance evaluation. In addition to the responsibilities set forth in this CIA for all Covered Persons, all Covered Administrators are specifically expected to continue to monitor and oversee activities within their areas of authority and shall annually certify in writing or electronically that, to the best of their knowledge, their facility or functional area is in material compliance with applicable Federal health care program requirements and the obligations of this CIA. For each Reporting Period, each Covered Administrator shall certify in writing or electronically that: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [insert name of care center], an area under my supervision. My job responsibilities include ensuring compliance with regard to the [insert name of care center]. To the best of my knowledge, except as otherwise described herein, the [insert name of care center] is in material compliance with applicable Federal health care program requirements and the obligations of the CIA.” If any Covered Administrator is unable to provide such a conclusion in the certification, the Covered Administrator shall include in the certification a written explanation of the reasons why he or she is unable to provide the conclusion and the steps being taken to address the issue(s) identified in the certification. Amedisys, Inc. and Amedisys Holding, LLC Corporate Integrity Agreement
Management Accountability and Certifications. Cephalon represents that compliance is a component of each employee’s performance objectives. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Cephalon employees (“Certifying Employees”) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify in writing or electronically that the applicable area of authority is compliant with Federal health care program requirements, FDA requirements, and the obligations of this CIA. The Certifying Employees include, at a minimum, the following: Chairman and Chief Executive Officer, Executive Vice President of Worldwide Medical and Regulatory Operations, Executive Vice President of Worldwide Pharmaceutical Operations, all business unit sales vice presidents, all business unit marketing vice presidents, all business unit sales directors, all business unit marketing directors, the Vice President of Worldwide Medical Affairs, and all medical directors of communications and medical science liaisons (MSLs). For each Reporting Period, each Certifying Employee shall certify in writing or electronically that: “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 [insert name of the department or functional area.] To the best of my knowledge, except as otherwise described herein, the [insert name of department or functional area] of Cephalon is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIA.”
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain AtriCure, Inc. employees (“Certifying Employees”) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify, in writing or electronically, that the applicable AtriCure, Inc. component is compliant with Federal health care program requirements, FDA requirements, and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following individuals from AtriCure, Inc.: • Xxxxx Xxxxxxxx, President and CEO • Xxxxxxx Xxxxx, Director of Marketing • Stewart Strong, VP, Domestic Sales • Xxx Xxxxxx, Director, Sales (East Region) CORPORATE INTEGRITY AGREEMENT ATRICURE, INC. • Xxxxx Xxxxxxxxx, Director, Sales (West Region) 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 [insert name of the department or functional area.] To the best of my knowledge, except as otherwise described herein, the [insert name of department or functional area] of AtriCure, Inc. is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIA.”
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Baxano Surgical 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 Baxano Surgical 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 and Chief Executive Officer; and executives in Marketing; Sales; Regulatory; Clinical Affairs;
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Lilly employees (“Certifying Employees”) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify, in writing or electronically, that the applicable Lilly component is compliant with Federal health care program requirements, FDA requirements, and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following individuals from Lilly: President and Chief Executive Officer; and Executive Vice President, Global Marketing and Sales. Corporate Integrity Agreement Xxx Xxxxx Company
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Lilly employees (“Certifying Employees”) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify, in writing or electronically, that the applicable Lilly component is compliant with Federal health care program requirements, FDA requirements, and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following individuals from Lilly: President and Chief Executive Officer; and Executive Vice President, Global Marketing and Sales. Corporate Integrity Agreement Xxx Xxxxx Company They also shall include, at minimum, the following individuals from Lilly USA: President, U.S. Operations; Senior Vice President, Account-Based Markets; Senior Vice President, Health Care Professional Markets; Vice President, Chief Marketing and Operations Officer; and all national and executive sales directors, brand leaders, and business unit leaders in the HCP Markets, executive directors and directors in Account-Based Markets, and executive directors and directors in Marketing and Operations. 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 [insert name of the department or functional area.] To the best of my knowledge, except as otherwise described herein, the [insert name of department or functional area] of Lilly is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIA.”
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain WellCare officials (“Certifying Employees”) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable WellCare component is compliant with Federal health care program requirements and the obligations of this CIA. The Certifying Employees include, at a minimum, the following: Chief Executive Officer; CFO; Chief Administrative Officer; Chief Medical Officer; General Counsel; President of National Health Plans; President of Florida/Hawaii Division; President of South Division; President of Northeast Division; Senior Vice President of Health Services; all Vice Presidents in Health Services Department; all Vice Presidents in Finance Department (Direct reports to CFO); Regional Chief Operating Officers or
Management Accountability and Certifications. In addition to the states as follows: “I have been trained on and understand the compliance requirements and responsibilities as they relate to [functional area], an area under my supervision. My job responsibilities include ensuring that the [functional area] remains compliant with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Mid Xxxxxx Policies and Procedures, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [functional area] of Mid Xxxxxx is in compliance with all applicable Federal health care program requirements and the obligations of the CIA. I understand that this certification is being provided to and relied upon by the United States.” If any Certifying Employee is unable to provide such a conclusion in the certification, he or she 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 issues identified.
