Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, the J&J CCO, members of the NALT, and certain officers or employees of each of the J&J Pharmaceutical Affiliates (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority. Each such Certifying Employee shall annually certify that the applicable J&J or J&J Pharmaceutical Affiliate 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: the J&J CCO, the members of the NALT, and the presidents, vice presidents, and/or heads of business units at the J&J Pharmaceutical Affiliates that are engaged in Covered Functions; the Presidents of Xxxxxxx Pharmaceuticals, Inc., Xxxxxxx Biotech, Inc., Patriot Pharmaceuticals, Inc., and Scios, Inc.; the Vice-Presidents of Human Resources; Vice- Presidents of Strategic Customer Group; the Vice-Presidents of Commercial Analytics; Vice-Presidents of Medical Affairs; Vice-Presidents of Communication and Public Affairs; Vice-Presidents of New Business Development; Chief Scientific Officers; Vice- President(s) of Finance; and, to the extent that a business performs Covered Functions and is not covered by the certification of one of the above-listed individuals, such other presidents, vice presidents, and heads of business units as would be necessary to ensure that there is a Certifying Employee from each such business unit at each J&J Pharmaceutical Affiliate. 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.
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.
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Forest officers or employees (“Certifying Employees”) are each specifically expected to monitor and oversee activities within their areas of authority and shall annually provide the certification in Section III.A.4, below, with regard to the Forest business area(s) under their authority. These Certifying Employees shall include, at a minimum, the following: Chief Executive Officer, Forest Laboratories, Inc. (FLI); President and Chief Operating Officer (FLI); Executive Vice-President of Global Marketing (FLI); Senior Vice-President and Chief Commercial Officer (FLI); Vice-President of Marketing Services, Forest Pharmaceuticals, Inc. (FPI); Vice-President of Managed Markets, Government and Policy (FLI); Vice-President of Marketing and Product Management (FLI); Vice-President of New Products (FPI); Corporate Vice-President of Business Development and Strategic Planning (FLI); Corporate Vice President (FLI) and President, Forest Research Institute, Inc. (FRI); President of Cerexa Administration; Senior Vice-President of Finance and Chief Financial Officer (FLI); Corporate Vice-President of Human Resources (FLI); Senior Vice-President of Sales (FPI); Vice-President (FRI) and Chief of Compliance (FLI); Executive-Vice President of Trade Sales and Development (FLI); Vice-President of Information Systems & Manufacturing/Operational Informatics (FLI); Vice-President of Regulatory Affairs (FRI), and, to the extent that a Forest business unit performs sales, marketing, promotion, pricing, contracting, regulatory affairs, compliance, and medical affairs functions is not covered by the certifications of one of the above-listed individuals, such other appropriate Forest executives, vice-presidents, and directors as would be necessary to ensure that there is a certifying officer or employee covering 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 [insert name of department or functional area], an area under my supervision. My job responsibilities include ensuring compliance by the [insert name of the department or functional area] with all applicable Federal health care program requirements, FDA requirements, the obligations of the CIA, and Forest’s policies and I have taken steps to promote such compliance. To...
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Daiichi 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 Daiichi 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: Executive Chairman and President of Daiichi; President, U.S. Commercial; Vice President Marketing and Access Strategy; Vice President Managed Markets and Key Account Management; Vice President Sales; Vice President Medical Affairs; Vice President Business Development and New Product Planning; Vice President Supply Chain and Technical Operations; Senior Vice President External Scientific Affairs; Executive Vice President Global Head of Development ; and, to the extent that a Daiichi business unit performs Covered Functions and is not covered by the certifications of one of the above-listed individuals, such other Daiichi executives, vice-presidents, or leaders of business units as would be necessary to ensure that there is a Certifying Employee from each such business unit engaged in Covered Functions. 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 [insert name of 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 Daiichi 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 Daiichi is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the Corporate Integrity Agreement. 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 certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification outlined above ...
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. 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.
Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Mylan employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Mylan business unit is compliant with applicable Federal health care program requirements with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: (1) Chief Financial Officer; (2) Head of Commercial Finance – North America; (3) Head of Government Reporting; (4) Head of Finance, Global Integrated Services – North America; and (5) Director, Accounts Receivable. 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 [insert name of 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, obligations of the Corporate Integrity Agreement, and Mylan policies applicable to [department or function], and I have taken steps to promote such compliance. To the best of my knowledge, the [insert name of department or functional area] of Mylan is in compliance with all applicable Federal health care program requirements and the obligations of the Corporate Integrity Agreement. 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 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 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 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. Within 120 days after the Effective Date, Boston Scientific represents that for each Covered Person who is an employee compliance shall be a component of his or her performance objective. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Boston Scientific 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 Boston Scientific Corporation component is compliant with Federal health care program requirements and the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following individuals from Guidant/CRM: President and all vice presidents of Sales and Marketing as well as the Vice President and General Manager of electrophysiology and the head of Clinical Affairs. For each Reporting Period, each Certifying Employee shall sign a certification that states: “I have been trained on and understand the applicable Federal health care program compliance requirements and obligations of the CIA 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 Guidant/CRM is in compliance with all applicable Federal health care program requirements and the obligations of the CIA.”
