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 [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, the J&J CCO, members of the NALT, and certain GSK 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 and 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: Presidentthe J&J CCO, GSKthe 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 heads Presidents of Xxxxxxx Pharmaceuticals, Inc., Xxxxxxx Biotech, Inc., Patriot Pharmaceuticals, Inc., and Scios, Inc.; the U.S. Pharma commercial business unitsVice-Presidents of Human Resources; Chairman, Research and DevelopmentVice- Presidents of Strategic Customer Group; Vice President, Strategic, Planning and Operationsthe Vice-Presidents of Commercial Analytics; Senior Vice President, NA Vice-Presidents of Medical Affairs; President, Pharmaceuticals Research Vice-Presidents of Communication and Public Affairs; Vice-Presidents of New Business Development; President, VaccinesChief Scientific Officers; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, Vice- President(s) of Finance; and, to the extent that a business unit performs Covered Functions and is not covered by the certification of one of the above- above-listed individuals, such other executivespresidents, vice-vice presidents, and directors heads of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitunit 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 [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 J&J 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 the [insert name of J&J Pharmaceutical Affiliate company] 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 GSK officers or AstraZeneca employees (“Certifying Employees”) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify certify, in writing or electronically, that the applicable business unit AstraZeneca component is compliant with applicable Federal health care program requirements, FDA requirements, and FDA requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the followingfollowing individuals from AstraZeneca: President, GSKU.S. Business; vice presidents of commercial functions (including those vice presidents with sales, marketing and brand responsibilities); sales directors (including national sales directors, area sales directors, and regional sales directors); senior brand leaders (commercial brand leaders and development brand leaders); the heads Vice President of the U.S. Pharma commercial business units; Chairman, Research Medical Affairs and Development; Vice President, Strategic, Planning and Operations; Senior Vice President, NA direct reports with responsibilities for Medical Affairs; President, Pharmaceuticals Research and Development; President, VaccinesAffairs or Field Medical Relations; 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 Executive Director 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 unitPromotional Regulatory Affairs. For each Reporting Period, each Certifying Employee shall sign a certification that states: Corporate Integrity Agreement AstraZeneca “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, and I acknowledge that I have the opportunity to obtain supplemental guidance on those requirements and responsibilities from the U.S. Compliance Department and my management when necessary. My job responsibilities include ensuring compliance with regard to of 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 AstraZeneca policies, and I have taken steps to promote such compliance. To In the best event that I have identified potential issues of my knowledge, except as otherwise described herein, the [insert name of department or functional area] of GSK is in non- compliance with these requirements, I have referred all such issues to the Legal Department or the U.S. Compliance Department for further review and follow-up. Apart from those referred issues, I am not currently aware of any violation of applicable Federal health care program requirements, FDA requirements, and the obligations requirements of the CIACorporate Integrity Agreement, or the requirements of AstraZeneca 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.

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK KDMC officers or employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority the hospital and shall certify annually certify that the applicable business unit is areas under their authority are 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: Presidentthe President & Chief Executive Officer; VP, GSKChief Legal & Regulatory Officer; the heads of the U.S. Pharma commercial business unitsVP, Chief Strategy Officer/CIO; ChairmanVP, Research and DevelopmentCFO; Vice PresidentVP, StrategicChief Medical Officer; VP, Planning and OperationsChief Administrative Officer; Senior Vice PresidentVP, NA Medical AffairsFacilities; PresidentVP, Pharmaceuticals Research and DevelopmentChief Nursing Officer; PresidentVP, VaccinesQuality; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement PresidentVP, 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-presidentsExecutive Director King’s Daughters Integrated Practices, and directors any other employees of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitKDMC with the title of Vice President or higher. For each Reporting Period, each Certifying Employee shall sign a certification that statesstates as follows: “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 that the [insert name of the department or functional area] remains compliant with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and GSK policiesKDMC Policies and Procedures, 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 KDMC is in compliance with all applicable Federal health care program requirements, FDA requirements, 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 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 issue(s) identified in the certificationissues identified.

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK Orthofix 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 Orthofix business unit unit, department, or functional area 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: Presidentthe Presidents and Chief Financial Officers for the Orthofix Spine Global Business Unit and for the Orthofix Orthopedics Global Business Unit, GSK; the heads Chief Executive Officer 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 DermatologyOrthofix N.V., and, to the extent that a an OFX or OSI business unit unit, department, or functional area performs Covered Functions functions related to government reimbursement, promotion, marketing, sales, contracting, Arrangements, or compliance and is not covered by the certification of one of the above- listed individualsabove certifications, such other appropriate executives, vice-presidents, and directors of business units directors, as would be necessary to ensure that there is a Certifying Employee from certifying officer or employee covering each such business unit, department, or functional area. For each Reporting Period, each Certifying Employee except the Chief Executive Officer of Orthofix N.V. 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 [OFX or OSI, as applicable] is in compliance with all applicable Federal health care program and FCA requirements, and the obligations of the CIA.” For each Reporting Period, the Chief Executive Officer of Orthofix N.V shall sign a certification that states: “I have been trained on and understand the compliance requirements and responsibilities as they relate to OFX and OSI. My job responsibilities include oversight of OFX and OSI. I have made reasonable inquiry regarding OFX and OSI’s compliance with all applicable Federal health care program requirements, and the obligations of the CIA. To the best of my knowledge, except as otherwise described herein, OFX and OSI are 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 GSK Halifax officers or employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority the hospital and shall certify annually certify that the applicable business unit is areas under their authority are 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: Presidentthe President & Chief Executive Officer, GSK; the heads of the U.S. Pharma commercial business units; Chairman, Research and Development; Vice President, Strategic, Planning and Operations; Senior Vice PresidentPresident & Chief Revenue Officer, NA the Executive Vice President & Chief Operating Officer, the Senior Vice President & Chief Quality Officer, the Executive Vice President & Chief Financial Officer, the Senior Vice President & Chief Medical Affairs; PresidentOfficer, Pharmaceuticals Research the Vice President & Chief Nursing Officer, the Vice President & Chief Surgical Services Officer, the Vice President of Operations, the Vice President & Service Line Administrator and Development; President, Vaccines; and any other employees of Halifax with the title of 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 unitPresident or higher. For each Reporting Period, each Certifying Employee shall sign a certification that statesstates as follows: “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 that the [insert name of the department or functional area] remains compliant with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and GSK policiesHalifax Policies and Procedures, 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 Halifax is in compliance with all applicable Federal health care program requirements, FDA requirements, 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 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 issue(s) identified in the certificationissues identified.

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK Par 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: Chief Executive Officer; President, GSK; the heads of the U.S. Pharma commercial business units; Chairman, Research Executive Vice President and Development; Vice President, Strategic, Planning and OperationsChief Financial Officer; Senior Vice President, NA Brand Sales and Marketing; Senior Vice President, Corporate Regulatory Affairs; Senior Vice President, Corporate Quality and Compliance; Senior Vice President, Sales; Director, 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- 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 Par 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 Par 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 Par Corporate Integrity Agreement 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 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 and FDA requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the following: President(1) Chief Financial Officer; (2) Head of Commercial Finance – North America; (3) Head of Government Reporting; (4) Head of Finance, 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, VaccinesGlobal Integrated Services – North America; and Vice GlaxoSmithKline LLC (5) Director, Accounts Receivable. Mylan 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 [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 GSK policiesMylan policies applicable to [department or function], 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 Mylan is in compliance with all applicable Federal health care program requirements, FDA requirements, requirements and the obligations of the CIACorporate 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 GSK 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, GSK; the heads of the U.S. Pharma commercial business units; Chairman, Research and DevelopmentCommercial; Vice President, Strategic, Planning 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, NA Medical President External Scientific Affairs; President, Pharmaceuticals Research and DevelopmentExecutive Vice President Global Head of Development ; President, Vaccines; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, and, to the extent that a Daiichi business unit performs Covered Functions and is not covered by the certification certifications of one of the above- above-listed individuals, such other Daiichi executives, vice-presidents, and directors or leaders of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitunit 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 GSK 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 GSK Daiichi is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIACorporate 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 GSK Forest officers or employees (“Certifying Employees”) are each specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that provide the applicable certification in Section III.A.4, below, with regard to the Forest business unit is compliant with applicable Federal health care program and FDA requirements and with the obligations of this CIAarea(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, GSKForest Research Institute, Inc. (FRI); the heads President of the U.S. Pharma commercial business units; Chairman, Research and Development; Vice President, Strategic, Planning and OperationsCerexa 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, NA Medical AffairsPresident of Trade Sales and Development (FLI); President, Pharmaceuticals Research and DevelopmentVice-President of Information Systems & Manufacturing/Operational Informatics (FLI); President, Vaccines; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America DermatologyVice-President of Regulatory Affairs (FRI), and, to the extent that a Forest business unit performs Covered Functions sales, marketing, promotion, pricing, contracting, regulatory affairs, compliance, and medical affairs functions is not covered by the certification certifications of one of the above- above-listed individuals, such other appropriate Forest executives, vice-presidents, and directors of business units as would be necessary to ensure that there is a Certifying Employee from 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 with regard to by the [insert name of the department or functional area] with all applicable Federal health care program requirements, FDA requirements, the obligations of the Corporate Integrity AgreementCIA, and GSK policies, Forest’s 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 Forest 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 GSK Novartis 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 Novartis 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, include the following: PresidentPresident NPC and Head Pharma, GSKNorth America; the heads of the U.S. Pharma commercial business units; ChairmanExecutive Vice President and North American Region Head, Research and DevelopmentOncology; Vice PresidentPresidents of commercial functions (including those vice presidents with sales, Strategicmarketing, Planning managed markets and Operationshis/her direct reports, new/mature products, Business Development & Licensing, commercial support, patient advocacy, patient services, and brand responsibilities); Senior sales management (including general managers and direct reports, regional directors, directors of sales, and business directors); senior brand leaders and direct reports (commercial brand leaders and development brand leaders); Vice President, NA Medical Affairs; President, President Oncology Drug Regulatory Novartis Pharmaceuticals Research and Development; President, Vaccines; and Vice GlaxoSmithKline LLC Corporation Corporate Integrity Agreement PresidentAffairs; Drug Regulatory Affairs US Head; Director Government Price Reporting Compliance Managed Markets Finance; the Vice President and Head Medical Affairs & Drug Regulatory Affairs; and the Senior Vice President or Head(s) Research and Development and/or Clinical Development and Medical Affairs and each of his/her respective direct reports with responsibilities for Clinical Development, Xxxxxxx North America DermatologyMedical Affairs, andField Medical Relations, to or Advertising & Promotion (as exists within respective departments); Vice President and Head Business & Administrative Services; US Oncology Head of Customer Innovation & Strategy; US Oncology Executive Director Therapeutic Area Marketing Analysis; US Oncology Executive Director Commercial Operations; and US Oncology Head Ethics & Compliance. This certification will not include individuals otherwise excluded as specified in the extent that a business unit performs CIA “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 unitPersons” definition. 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 Novartis 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 Novartis processes for reporting potential misconduct for further review and follow-up. Apart from those referred issues, the I am not currently aware in [insert name of department or functional areaname] of GSK is in compliance with all any violations of applicable Federal health care program requirements, FDA requirements, and the obligations requirements of the CIACorporate Integrity Agreement, or the requirements of Novartis 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.

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK officers or Allergan employees (“Certifying Employees”) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify certify, in writing or electronically, that the applicable business unit Allergan component is compliant with applicable Federal health care program requirements, FDA requirements, and FDA requirements and with the obligations of this CIA. These Certifying Employees shall include, at a minimum, the followingfollowing individuals from Allergan: Chief Executive Officer; President; Corporate Vice President, GSKNorth America; the heads of the U.S. Pharma commercial business unitsCorporate Vice President, Allergan Medical; ChairmanCorporate Vice President, Research and DevelopmentGlobal Marketing; Vice President, Strategic, Planning and OperationsMedical Affairs; Senior Vice President, NA Medical Affairs; President, Pharmaceuticals Research and Development; President, VaccinesManaged Markets; and the Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, and, to the extent that a business unit performs Covered Functions Presidents of U.S. Dermatology Sales and is not covered by the certification of one of the above- listed individuals, such other executives, vice-presidents, Marketing; U.S. Managed Markets; U.S. Eye Care Sales and directors of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitMarketing; U.S. Neurosciences Sales and Marketing; U.S. Commercial Operations; Health Sales and Marketing; Facial Aesthetics Sales and Marketing; Breast Aesthetics Sales and Marketing; and Global Strategic Marketing. 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 monitoring and oversight of 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 Allergan 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 make 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 Forest officers or employees (“Certifying Employees”) are each specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that provide the applicable certification in Section III.A.4, below, with regard to the Forest business unit is compliant with applicable Federal health care program and FDA requirements and with the obligations of this CIAarea(s) under Corporate Integrity Agreement Forest Laboratories, Inc. 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, GSKForest Research Institute, Inc. (FRI); the heads President of the U.S. Pharma commercial business units; Chairman, Research and Development; Vice President, Strategic, Planning and OperationsCerexa 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, NA Medical AffairsPresident of Trade Sales and Development (FLI); President, Pharmaceuticals Research and DevelopmentVice-President of Information Systems & Manufacturing/Operational Informatics (FLI); President, Vaccines; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America DermatologyVice-President of Regulatory Affairs (FRI), and, to the extent that a Forest business unit performs Covered Functions sales, marketing, promotion, pricing, contracting, regulatory affairs, compliance, and medical affairs functions is not covered by the certification certifications of one of the above- listed individuals, such other appropriate Forest executives, vice-presidents, and directors of business units as would be necessary to ensure that there is a Certifying Employee from 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 with regard to by the [insert name of the department or functional area] with all applicable Federal health care program requirements, FDA requirements, the obligations of the Corporate Integrity AgreementCIA, and GSK policies, Forest’s 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 Forest 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.. Corporate Integrity Agreement Forest Laboratories, Inc.

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 [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 BIPI 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 BIPI 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 GSK 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 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: Presidentthe Chief Executive Officer of Elan Corporation, GSK; plc, the heads President of the U.S. Pharma commercial business units; ChairmanElan Corporation plc, 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 all appropriate Elan executives, vice-presidents, and directors of business units 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 unitof the following functions: Medical Affairs and Materials Related Functions, Government Pricing and Contracting Related Functions, and (if applicable in 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 [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 GSK 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 GSK is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations requirements of the CIACorporate 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.

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK EHS officers and Endo officers or employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify certify, consistent with the language set forth below, that the applicable Endo business unit or area of authority 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 of Endo Health Solutions (or parent company); Chief Operating Officer, Pharmaceuticals; Senior Vice President Branded Pharma; Vice President and General Manager, Urology; Sales Director, Urology; Vice President Business Operations and Planning; Marketing Director Pain; Sales Director Pain; Senior Director, Managed Markets and Trade; Senior Director and General Manager Supprelin LA; Executive Vice President, GSK; the heads of the U.S. Pharma commercial business units; Chairman, Research and DevelopmentDevelopment and Chief Scientific Officer; Vice President Development Operations; Vice President, Strategic, Planning and OperationsRegulatory Affairs; Senior Vice President, NA Director Medical Affairs; President, Pharmaceuticals Research Vice President PVRM and DevelopmentSenior Clinical Advisor; President, Vaccines; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, and, to the extent that a an Endo business unit or functional area performs Covered Functions and is not covered by the certification certifications of one of the above- above-listed individuals, such other Endo or EPI executives, vice-presidents, and directors or leaders of business units an area of authority as would be necessary to ensure that there is a Certifying Employee from each such business unitunit 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 GSK Endo 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 Endo is in compliance with Endo Pharmaceuticals Inc. Corporate Integrity Agreement all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIACorporate 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 GSK Xxxxxxxx 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 Xxxxxxxx business unit unit, department, or 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: Xxxxxxxx’x Chief Executive Officer/President, GSK; the heads Chief Financial Officer, General Manager 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; Substance Abuse and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America DermatologyPresident Pain Care Sales, and, to the extent that a Xxxxxxxx business unit unit, department, or functional area performs Covered Functions functions related to government reimbursement, promotion, marketing, sales, contracting, Arrangements, or compliance and is not covered by the certification of one of the above- listed individualsabove certifications, such other appropriate executives, vice-presidents, and directors of business units directors, as would be necessary to ensure that there is a Certifying Employee from certifying officer or employee covering each such business unit, department, or functional area. 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 Xxxxxxxx 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 GSK Amgen 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 Amgen 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; Executive Vice President, StrategicGlobal Commercial Operations; Executive Vice President, Planning and Research & Development; Senior Vice President, U.S. Commercial Operations; Senior Vice President, NA Global Marketing & Commercial Development; Senior Vice President & Chief Medical Officer, Global Development; Senior Vice President, Global Value & Access; Senior Vice President, Global Regulatory Affairs & Safety; Vice President, Scientific Affairs; President, Pharmaceuticals Research and Developmentthe general managers of Amgen U.S. commercial business units; President, Vaccines; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, and, to the extent that a an Amgen business unit performs Covered Functions and is not covered by the certification certifications of one of the above- above-listed individuals, such other Amgen executives, vice-presidents, and directors or leaders of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitunit 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 GSK Amgen 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 Amgen is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIACorporate Integrity Agreement. I understand that this certification is being provided to and relied upon by the United States.” Corporate Integrity Agreement Amgen Inc. 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 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 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: PresidentChief Executive Officer, GSK; the heads Senior Vice President and Head of the U.S. Pharma commercial business units; ChairmanRare 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 and Head of Research and Development; Vice President, Strategic, Planning and Operations; Senior Vice PresidentPresident and Head of Global Commercial Operations, NA Medical Affairsand Senior Vice President and Head of Global Market Access; 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 Shire business unit performs Covered Functions and is not covered by the certification certifications of one of the above- above-listed individuals, such other Shire executives, vice-presidents, and directors or leaders of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitunit 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 GSK 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 GSK [insert applicable Shire entity name] is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIACorporate 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 GSK Xxxxxx officers or employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority the hospital and shall certify annually certify that the applicable business unit is areas under their authority are 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: Presidentthe Chief Executive Officer, GSK; the heads of Chief Financial Officer, the U.S. Pharma commercial business units; ChairmanChief Operating Officer, Research and Development; Vice Presidentthe Chief Medical Officer, 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-presidentsChief Nursing Officer, and directors any other employees of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitXxxxxx with the title of Vice President or higher. For each Reporting Period, each Certifying Employee shall sign a certification that statesstates as follows: “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 that the [insert name of the department or functional area] remains compliant with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and GSK policiesXxxxxx Policies and Procedures, 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 Xxxxxx is in compliance with all applicable Federal health care program requirements, FDA requirements, 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 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 issue(s) identified in issues identified. Within 120 days after the Effective Date, Xxxxxx shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required certification).

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK Aegerion 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 Aegerion 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(i) the following officers or employees of Novelion Therapeutics Inc., GSKby virtue of Novelion Therapeutics Inc.’s contractual service obligations to Aegerion: the Global Chief Compliance Officer; the heads Chief Commercial Officer; the Head of the U.S. Pharma commercial business units; Chairman, Research and & Development; and the Chief Financial and Administration Officer; and (ii) the following officers or employees of Aegerion: the President & Chief Accounting Officer; the Senior Vice President, Strategic, Planning and President of Technical Operations; the Senior Vice President, NA President of Medical Affairs; President, Pharmaceuticals Research and the President of Commercial U.S.; the Senior Vice President of Regulatory; the Vice President of Clinical Development; Presidentand the Senior Vice President of Global Market Access, VaccinesPatient Advocacy and REMS; and Vice GlaxoSmithKline LLC Corporate Integrity Agreement President, Xxxxxxx North America Dermatology, and, (iii) to the extent that a an Aegerion business unit performs Covered Functions and is not covered by the certification certifications of one of the above- above-listed individuals, such other Aegerion executives, vice-vice presidents, and directors or leaders of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitunit 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 GSK Aegerion 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 Aegerion is in compliance with all applicable Federal health care program requirements, FDA requirements, and the obligations of the CIACorporate 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 above. Within 120 days after the Effective Date, Aegerion shall develop and implement a written process for Certifying Employees to follow for the steps being taken purpose of completing the certification required by this section (e.g., reports that must be reviewed, sub-certifications that must be obtained, etc. prior to address the issue(s) identified in Certifying Employee making the required certification).

Management Accountability and Certifications. In addition to the responsibilities set forth in this CIA for all Covered Persons, certain GSK Tuomey officers or employees (Certifying Employees) are specifically expected to monitor and oversee activities within their areas of authority the hospital and shall certify annually certify that the applicable business unit is areas under their authority are 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: Presidentthe Chief Executive Officer, GSK; the heads of Chief Financial Officer, the U.S. Pharma commercial business units; ChairmanChief Operating Officer, Research and Development; Vice Presidentthe Chief Medical Officer, 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-presidentsChief Nursing Officer, and directors any other employees of business units as would be necessary to ensure that there is a Certifying Employee from each such business unitTuomey with the title of Vice President or higher. For each Reporting Period, each Certifying Employee shall sign a certification that statesstates as follows: “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 that the [insert name of the department or functional area] remains compliant with all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and GSK policiesTuomey Policies and Procedures, 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 Tuomey is in compliance with all applicable Federal health care program requirements, FDA requirements, 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 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 issue(s) identified in issues identified. Within 120 days after the Effective Date, Tuomey shall develop and implement a written process for Certifying Employees to follow for the purpose of completing the certification required by this section (e.g., reports that must be reviewed, assessments that must be completed, sub-certifications that must be obtained, etc. prior to the Certifying Employee making the required 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) Executives are specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable 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: 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 To the extent that a business unit performs Covered Functions and functional area 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 unitExecutive, the person in charge 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 [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 GSK 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 GSK is in compliance with all any violations of applicable Federal health care program requirementslaws and regulations, FDA requirements, and the obligations of the CIACorporate 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 GSK Xxxxxxxx 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 Xxxxxxxx business unit unit, department, or 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: Xxxxxxxx’x Chief Executive Officer/President, GSK; the heads Chief Financial Officer, General Manager 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; Substance Abuse and Vice GlaxoSmithKline LLC Corporate Integrity Agreement PresidentPresident Pain Care Sales, Xxxxxxx North America DermatologyDirector of Billing, Director of Laboratory Operations, Laboratory Director, and, to the extent that a Xxxxxxxx business unit unit, department, or functional area performs Covered Functions functions related to government reimbursement, billing and claims, promotion, marketing, sales, contracting, Arrangements, or compliance and is not covered by the certification of one of the above- listed individualsabove certifications, such other appropriate executives, vice-presidents, and directors of business units directors, as would be necessary to ensure that there is a Certifying Employee from certifying officer or employee covering each such business unit, department, or functional area. 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 Xxxxxxxx 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.