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, 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, the J&J CCO, members of the NALT, and certain Halifax 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 the hospital and shall certify annually certify that the applicable J&J or J&J Pharmaceutical Affiliate 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: the J&J CCOPresident & Chief Executive Officer, the members Senior Vice President & Chief Revenue Officer, 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 Officer, the Vice President & Chief Nursing Officer, the Vice President & Chief Surgical Services Officer, the Vice President of Operations, the NALT, Vice President & Service Line Administrator and any other employees of Halifax with the presidents, vice presidents, and/or heads title 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 AffiliateVice 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 that the [department or functional area] remains compliant with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Halifax Policies and Procedures, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [department or functional area] of Halifax is in compliance with regard 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, 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, the J&J CCO, members of the NALT, and certain officers or AstraZeneca 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 authority and shall annually certify certify, in writing or electronically, that the applicable J&J or J&J Pharmaceutical Affiliate 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: the J&J CCOPresident, the members U.S. Business; vice presidents of the NALTcommercial functions (including those vice presidents with sales, marketing and brand responsibilities); sales directors (including national sales directors, area sales directors, and the presidents, vice presidents, and/or heads of business units at the J&J Pharmaceutical Affiliates that are engaged in Covered Functionsregional sales directors); senior brand leaders (commercial brand leaders and development brand leaders); 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 Vice President of Medical Affairs and direct reports with responsibilities for Medical Affairs or Field Medical Relations; and the Executive Director of Promotional Regulatory 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: 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 of the [insert name of the department or functional area] with regard all applicable Federal health care program requirements, FDA requirements, obligations of the Corporate Integrity Agreement, and AstraZeneca policies, and I have taken steps to promote such compliance. In the event that I have identified potential issues of 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, requirements of the Corporate 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, the J&J CCO, members of the NALT, and certain KDMC 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 the hospital and shall certify annually certify that the applicable J&J or J&J Pharmaceutical Affiliate 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: the J&J CCOPresident & Chief Executive Officer; VP, the members of the NALTChief Legal & Regulatory Officer; VP, Chief Strategy Officer/CIO; VP, CFO; VP, Chief Medical Officer; VP, Chief Administrative Officer; VP, Facilities; VP, Chief Nursing Officer; VP, Quality; and VP, Executive Director King’s Daughters Integrated Practices, and any other employees of KDMC with the presidents, vice presidents, and/or heads title 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 AffiliateVice 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 that the [department or functional area] remains compliant with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and KDMC Policies and Procedures, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [department or functional area] of KDMC is in compliance with regard 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, 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, the J&J CCO, members of the NALT, and certain Tuomey 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 the hospital and shall certify annually certify that the applicable J&J or J&J Pharmaceutical Affiliate 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: the J&J CCOChief Executive Officer, the members of Chief Financial Officer, the NALTChief Operating Officer, the Chief Medical Officer, the Chief Nursing Officer, and any other employees of Tuomey with the presidents, vice presidents, and/or heads title 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 AffiliateVice 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 that the [department or functional area] remains compliant with all applicable Federal health care program requirements, obligations of the Corporate Integrity Agreement, and Tuomey Policies and Procedures, and I have taken steps to promote such compliance. To the best of my knowledge, except as otherwise described herein, the [department or functional area] of Tuomey is in compliance with regard 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, 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, the J&J CCO, members of the NALT, certain EHS officers and certain Endo 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 authority and shall annually certify certify, consistent with the language set forth below, that the applicable J&J or J&J Pharmaceutical Affiliate 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: the J&J CCOPresident and Chief Executive Officer of Endo Health Solutions (or parent company); Chief Operating Officer, the members of the NALTPharmaceuticals; Senior Vice President Branded Pharma; Vice President and General Manager, Urology; Sales Director, Urology; Vice President Business Operations and the presidentsPlanning; Marketing Director Pain; Sales Director Pain; Senior Director, vice presidentsManaged Markets and Trade; Senior Director and General Manager Supprelin LA; Executive Vice President, and/or heads of business units at the J&J Pharmaceutical Affiliates that are engaged in Covered FunctionsResearch and Development and Chief Scientific Officer; the Presidents of Xxxxxxx PharmaceuticalsVice President Development Operations; Vice President, Inc., Xxxxxxx Biotech, Inc., Patriot Pharmaceuticals, Inc., and Scios, Inc.Regulatory Affairs; the Vice-Presidents of Human Resources; Vice- Presidents of Strategic Customer Group; the Vice-Presidents of Commercial Analytics; Vice-Presidents of Senior Director Medical Affairs; Vice-Presidents of Communication Vice President PVRM and Public Affairs; Vice-Presidents of New Business Development; Chief Scientific Officers; Vice- President(s) of FinanceSenior Clinical Advisor; 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-listed individuals, such other Endo or EPI executives, vice-presidents, vice presidents, and heads 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 unit at each J&J Pharmaceutical Affiliateor 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 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 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 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, the J&J CCO, members of the NALT, and certain Orthofix 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 authority and shall annually certify that the applicable J&J Orthofix business unit, department, or J&J Pharmaceutical Affiliate business unit 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: the J&J CCOPresidents and Chief Financial Officers for the Orthofix Spine Global Business Unit and for the Orthofix Orthopedics Global Business Unit, the members Chief Executive Officer of the NALTOrthofix N.V., 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 an OFX or OSI business 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 presidentsappropriate executives, vice vice-presidents, and heads 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 at each J&J Pharmaceutical Affiliateunit, 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 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, and the obligations of the CIA.” 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 Xxxxxxxx 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 authority and shall annually certify that the applicable J&J Xxxxxxxx business unit, department, or J&J Pharmaceutical Affiliate 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: the J&J CCOXxxxxxxx’x Chief Executive Officer/President, the members Chief Financial Officer, General Manager of the NALTSubstance Abuse and Vice President Pain Care Sales, and the presidentsDirector of Billing, vice presidentsDirector of Laboratory Operations, and/or heads of business units at the J&J Pharmaceutical Affiliates that are engaged in Covered Functions; the Presidents of Xxxxxxx PharmaceuticalsLaboratory Director, 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 Xxxxxxxx business 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 presidentsappropriate executives, vice vice-presidents, and heads 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 at each J&J Pharmaceutical Affiliateunit, 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 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.