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 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 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 Daiichi Shire 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 Shire business unit is compliant with applicable Federal health care program requirements and FDA requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: Chief Executive Chairman and President of Daiichi; PresidentOfficer, 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; and Head of the Rare Diseases Business Unit, Senior Vice President and Head of the Internal Medicine Business Unit, Senior Vice President and Head of the Gastrointestinal Disease Business Unit, Senior Vice President and Head of the Shire North American Group, Inc. Corporate Integrity Agreement Neuroscience Business Unit, Executive Vice President Global and Head of Development Research and Development, Senior Vice President and Head of Global Commercial Operations, and Senior Vice President and Head of Global Market Access; and, to the extent that a Daiichi Shire business unit performs Covered Functions and is not covered by the certifications of one of the above-listed individuals, such other Daiichi Shire 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 or functional area 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 Shire 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 [insert applicable Shire entity name] 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 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 Daiichi officers or employees (Certifying Employees) Executives are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable Daiichi business unit functional area 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 To the extent that a Daiichi business unit performs Covered Functions and functional area is not covered by the certifications certification 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 Executive, the person in Covered Functionscharge of that functional area shall certify. For each Reporting Period, each Certifying Employee Executive or person in charge of the applicable functional area 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 requirementslaws and regulations, obligations of the Corporate Integrity Agreement, and Daiichi applicable DaVita HealthCare Partners policies, and I have taken steps to promote such compliance. To In the best event that I have identified potential issues of my knowledgenoncompliance with these requirements, except as otherwise described hereinI have referred all such issues consistent with the processes of DaVita HealthCare Partners for reporting potential misconduct for further review and follow-up. Apart from those referred issues, and any issues of which I have been made aware by DaVita HealthCare Partners’ counsel because they have been brought to the [insert name attention of department OIG, any other relevant government agency or functional area] entity, or the CIA Monitor, I am not currently aware of Daiichi is in compliance with all any violations of applicable Federal health care program requirementslaws and regulations, FDA requirements, and the obligations of the Corporate Integrity Agreement, or the requirements of the policies of DaVita HealthCare Partners. I understand that this certification is being provided to and relied upon by the United States.” If any Certifying Employee Executive or person in charge of the applicable functional area is unable to provide such a conclusion in the certification, the Certifying Employee Executive or person in charge of the applicable functional area 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.written explanation. DaVita HealthCare Partners Inc. Corporate Integrity Agreement

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain Daiichi Elan 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 Elan business unit is compliant with applicable Federal health care program and FDA requirements requirements, and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: the Chief Executive Chairman and Officer of Elan Corporation, plc, the President of Daiichi; PresidentElan Corporation plc, 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 all appropriate Elan executives, vice-presidents, or leaders of business units and directors as would be necessary to ensure that there is a Certifying Employee from certifying officer or executive-level employee with management responsibility for each such business unit engaged of the following functions: Medical Affairs and Materials Related Functions, Government Pricing and Contracting Related Functions, and (if applicable in Covered the future) Promotion Related 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 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 In the event that I have taken steps identified potential issues of noncompliance with these requirements, I have referred all such issues to promote such compliancethe Compliance Department for further review and follow-up in accordance with Elan’s policies and procedures. To the best Apart from those referred issues, I am not currently aware of my knowledge, except as otherwise described herein, the [insert name any violation of department or functional area] of Daiichi is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations requirements of the Corporate Integrity Agreement, or the requirements of Elan’s policies. 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.