Common use of Implementation Report Clause in Contracts

Implementation Report. Within 120 days after the Effective Date, Genova shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names of the Board members who are responsible for satisfying the Board compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by Genova; 7. the Training Plan required by Section III.C.1 and a description of the Board training required by Section III.C.2 (including a summary of the topics covered, the length of the training, and when the training was provided); 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IRO; 9. a description of the risk assessment and internal review process required by Section III.E; 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;

Implementation Report. Within 120 days after the Effective Date, Genova Progenity shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names of the Board members who are responsible for satisfying the Board compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the all Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by GenovaIII.B; 76. the Training Plan required by Section III.C.1 and a description of the Board training required by Section III.C.2 (including a summary of the topics covered, the length of the training, and when the training was provided); 7. a description of (a) the Focus Arrangements Tracking System required by Section III.D.1.a, (b) the internal review and approval process required by Section III.D.1.g; and (c) the tracking and monitoring procedures and other Focus Arrangements Procedures required by Section III.D.1; 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova Progenity or that it does not have a prohibited relationship with Progenity as set forth in Section III.E.4, that includes a summary of all current and prior engagements or relationships between Genova Progenity and the IRO, as applicable; 9. a description of the risk assessment and internal review process required by Section III.EIII.F; 10. a description of the Disclosure Program required by Section III.FIII.G; 11. a description of the Ineligible Persons screening and removal process required by Section III.GIII.H; 12. a copy of GenovaProgenity’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.IIII.J;

Implementation Report. Within 120 90 days after the Effective Date, Genova Xxxxx shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA IA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names of the Board members who are responsible for satisfying the Board compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 III.A.2; 63. a list of the Policies and Procedures required by Section III.B III.B. and a copy of all current order and/or requisition forms in use by GenovaXxxxx; 74. a copy of the Training Plan notice required by Section III.C.1 and III.C, a description of where the Board training required by Section III.C.2 (including a summary of the topics covered, the length of the trainingnotice is posted, and when the training date the notice was provided)posted; 85. the following information regarding the IRO(s): IRO: (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIAIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova Xxxxx that includes a summary of all current and prior engagements between Genova Xxxxx and the IRO; 9. a description of the risk assessment and internal review process required by Section III.E; 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 126. a copy of Genova’s the documentation (e.g. search result print screens) demonstrating that Xxxxx has screened all Covered Persons against the Exclusion List as required by Section III.F within 30 days of the Effective Date; 7. a copy of Xxxxx’x policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.IIII.H;

Implementation Report. Within 120 150 days after the Effective Date, Genova Novartis shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Chief Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Chief Compliance Officer may have; 2. the names and positions of the members of the Country Compliance Committee required by Section III.AIII.A.2; 3. the names of the Board members who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for to be followed by Certifying Employees to follow in order to complete connection with completing the certification required by Section III.A.4; 5. a copy of the name, business address, business phone number, letter (including all attachments) required by Sections II.C.11 and position III.B.1 sent to each party employing Third Party Personnel; a list of all existing co-promotion and other applicable agreements with the party employing the Third Party Personnel; and a description of the Chief Clinical Officer required by Section III.A.5 entities’ responses to Novartis’ letter; 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by GenovaIII.B.2; 7. the Training Plan required by Section III.C.1 and a description of the Board of Directors training required by Section III.C.2 (including a summary of the topics covered, the length of the training, training and when the training was provided); 8. a description of the risk assessment and internal review process required by Section III.D; 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix Appendices A and B to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova Novartis that includes a summary of all current and prior engagements between Genova Novartis and the IRO; 9. a description of the risk assessment and internal review process required by Section III.E; 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;

Implementation Report. Within 120 days after the Effective Date, Genova Xxxxxx shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names of the Board members who are responsible for satisfying the Board of Managers compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by GenovaIII.B; 76. the Training Plan required by Section III.C.1 and a description of the Board of Managers training required by Section III.C.2 (including a summary of the topics covered, the length of the training, and when the training was provided); 87. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IROXxxxxx; 98. a description of the risk assessment and internal review process required by Section III.E; 109. a description of the Disclosure Program required by Section III.F; 1110. a description of the Ineligible Persons screening and removal process required by Section III.G; 1211. a copy of Genova’s Xxxxxx’x policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I; 12. a list of all of Xxxxxx’x locations (including locations and mailing addresses), the corresponding name under which each location is doing business, and the location’s Federal health care program provider number and/or supplier number(s); 13. a description of Xxxxxx’x corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and

Implementation Report. Within 120 days after the Effective Date, Genova UMHS shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Chief Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Chief Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.AIII.A.2; 3. the names of the Board members who are responsible for satisfying the Board of Curators compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description a copy of the Chief Clinical Officer UMHS’s Code of Conduct required by Section III.A.5 III.B.1; 6. a list summary of the all Policies and Procedures required by Section III.B III.B.2 (copies of the Policies and a copy of all current order and/or requisition forms in use by GenovaProcedures shall be made available to OIG upon request); 7. the Training Plan required by Section III.C.1 and a description of the Board of Curators training required by Section III.C.2 (including a summary of the topics covered, the length of the training, and when the training was provided); 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between UMHS and the IRO; and (de) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IROUMHS; 9. a description of the risk assessment and internal review process required by Section III.E; 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;

Implementation Report. ‌ Within 120 150 days after the Effective Date, Genova Pfizer shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Compliance Officer may have;have;‌ 2. the names and positions of the members of the Compliance Committee required by Section III.A;III.A.2;‌ 3. the names of the Board members of the RCC who are responsible for satisfying the Board compliance obligations described in Section III.A.3;III.A.3;‌ 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4;III.A.4;‌ 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by GenovaIII.B.3; 76. the Training Plan required by Section III.C.1 and a description of the Board RCC training required by Section III.C.2 (including a summary of the topics coveredcovered in the training for Covered Persons and for the RCC, the length of the each type of training, and when the training was provided);provided);‌ (a) a copy of the letter (including all attachments) required by Section III.C.4 sent to each party employing Third Party Personnel; (b) a list of all existing co-promotion and other applicable agreements with the party employing the Third Party Personnel; and (c) a description of the entities' response to Pfizer’s letter;‌ 8. a description of the Risk Assessment and Internal Review Process required by Section III.D;‌ 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate demonstrate‌ that the IRO has the qualifications outlined in Appendix A to this CIAA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IRO; 9. a description of the risk assessment and internal review process required by Section III.EPfizer; 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;III.G;‌

Implementation Report. Within 120 days after the Effective Date, Genova RMS shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.AIII.A.2; 3. the names of the Board members who are responsible for satisfying the Board compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by GenovaIII.B.1; 76. the Training Plan required by Section III.C.1 and a description of the Board training required by Section III.C.2 (including a summary of the topics covered, the length of the training, training and when the training was provided); 7. a description of the risk assessment and internal review process required by Section III.D; 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova RMS that includes a summary of all current and prior engagements between Genova RMS and the IRO; ; 9. a description of the risk assessment and internal review process required by Section III.E; 10. a description of the Disclosure Program required by Section III.F; 1110. a description of the Ineligible Persons screening and removal process required by Section III.G; 11. a description of the FFMP required by Section III.K; 12. a copy description of Genovathe policies, procedures, and systems implemented pursuant to the Requirements Relating to Certain Promotional and Non-Promotional Activities outlined in Section III.L; 13. a certification from the Compliance Officer that information regarding Payments has been posted on RMS’s policies and procedures regarding the identification, quantification and repayment of Overpayments website as required by Section III.IIII.M; 14. a list of all of RMS’s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; and the locations’ Medicare and state Medicaid provider number and/or supplier number(s) if any; 15. a description of RMS’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and 16. the certifications required by Section V.C.

Implementation Report. Within 120 days after the Effective Date, Genova USPh shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.AIII.A.2; 3. the names of the Board members who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3; 4. the names and positions a copy of the Certifying Employees USPh’s Code of Conduct required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4III.B.1; 5. the name, business address, business phone number, and position description a summary of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the all Policies and Procedures required by Section III.B III.B.2 (copies of the Policies and a copy of all current order and/or requisition forms in use by GenovaProcedures shall be made available to OIG upon request); 76. the Training Plan required by Section III.C.1 and a description of the Board of Directors training required by Section III.C.2 (including a summary of the topics covered, the length of the training, and when the training was provided); 87. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between USPh and the IRO; and (de) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IROUSPh; 98. a description of the risk assessment and internal review mitigation process required by Section III.E; 109. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;

Implementation Report. Within 120 days after the Effective Date, Genova SUN shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.AIII.A.2; 3. the names of the Board members who are responsible for satisfying the Board compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. (a) a copy of the name, business address, business phone number, letter (including all attachments) required by Sections II.C.8 and position III.B.1 sent to each party employing Third Party Personnel; (b) a list of all existing co-promotion and other applicable agreements with the party employing the Third Party Personnel; and (c) a description of the Chief Clinical Officer required by Section III.A.5 entities’ responses to SUN’s letter; 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by GenovaIII.B.1; 7. the Training Plan required by Section III.C.1 and a description of the Board training required by Section III.C.2 (including a summary of the topics covered, the length of the training, training and when the training was provided); 8. a description of the risk assessment and internal review process required by Section III.D; SUN Corporate Integrity Agreement 9. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova SUN that includes a summary of all current and prior engagements between Genova SUN and the IRO; 9. a description of the risk assessment and internal review process required by Section III.E; 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;

Implementation Report. Within 120 days after the Effective Date, Genova Silver Lake shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall) to OIG that includes, at a minimum, include:the following information:‌ 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary detailed description of other any noncompliance job responsibilities the Compliance Officer may have;responsibilities;‌ 2. the names and positions of the members of the Compliance Committee required by Section III.A;III.A.2;‌ 3. the names of the Board members who are responsible for satisfying the Board compliance obligations requirements described in Section III.A.3;III.A.3;‌ 4. the following information regarding the individual or entity retained by the Board to be the Compliance Expert: (a) identity, address, and phone number; (b) information to demonstrate the individual’s or entity’s expertise in compliance with Federal health care program requirements, and (c) a certification from the Compliance Expert that they do not have a current or prior relationship to Silver Lake that would cause a reasonable person to question the Compliance Expert’s objectivity in performing the review.‌ 5. the names and positions of the Certifying Employees Covered Persons required by Section III.A.4 and a copy of the written process for Certifying Employees Covered Persons to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ;III.A.4;‌ 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by GenovaIII.B; 7. the Training Plan required by Section III.C.1 and a description of the Board training required by Section III.C.2 (including a summary of the topics covered, the length of the training, and when the training was provided);provided);‌ 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova Silver Lake that includes a summary of all current and prior engagements between Genova Silver Lake and the IRO;IRO;‌ 9. a description of the risk assessment and internal review process required by Section III.E; III.E;‌ 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;III.G;‌

Implementation Report. Within 120 days after the Effective Date, Genova Xxxxxx shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.A; 3. the names of the Board members who are responsible for satisfying the Board of Directors compliance obligations described in Section III.A.3III.A.2; 43. the names and positions of the Certifying Employees required by Section III.A.4 and III.A.3; 4. a copy of the written process for Certifying Employees to follow in order to complete the certification Xxxxxx’s Code of Conduct required by Section III.A.4III.B.1; 5. the name, business address, business phone number, and position description a summary of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the all Policies and Procedures required by Section III.B (copies of the Policies and a copy of all current order and/or requisition forms in use by GenovaProcedures shall be made available to OIG upon request); 76. the Training Plan required by Section III.C.1 and a description of the Board of Directors training required by Section III.C.2 (including a summary of the topics covered, the length of the training, and when the training was provided); 7. a description of (a) the Focus Arrangements Tracking System required by Section III.D.1.a, (b) the internal review and approval process required by Section III.D.1.e; and (c) the tracking and monitoring procedures and other Focus Arrangements Procedures required by Section III.D.1; 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between Balboa and the IRO; and (de) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IROBalboa; 9. a description of the risk assessment and internal review process required by Section III.EIII.F; 10. a description of the Disclosure Program required by Section III.F; 11. a description of the Ineligible Persons screening and removal process required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;

Implementation Report. Within 120 days after the Effective Date, Genova Life Spine shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (“Implementation Report”). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.AIII.A.2; 3. the names of the Board members who are responsible for satisfying the Board compliance obligations described in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the Policies and Procedures required by Section III.B III.B.1 and a copy of all current order and/or requisition forms in use by Genovastatement that indicates which activities Life Spine is not currently engaged in; 76. the Training Plan required by Section III.C.1 and a description of the Board training required by Section III.C.2 (including a summary of the topics covered, the length of the training, training and when the training was provided); 7. a description of the risk assessment and internal review process required by Section III.D; 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova Life Spine that includes a summary of all current and prior engagements between Genova Life Spine and the IRO; ; 9. a description of the risk assessment and internal review process required by Section III.E; 10. a description of the Disclosure Program required by Section III.F; 1110. a description of the Ineligible Persons screening and removal process required by Section III.G; 11. a description of the FFMP required by Section III.K; 12. a copy description of Genovathe policies, procedures, and systems implemented pursuant to the Requirements Relating to Certain Non-Promotional Activites outlined in Section III.L; 13. a certification from the Compliance Officer that information regarding Payments has been posted on Life Spine’s policies and procedures regarding the identification, quantification and repayment of Overpayments website as required by Section III.IIII.N; 14. a list of all of Life Spine’s locations (including locations and mailing addresses); the corresponding name under which each location is doing business; and the locations’ Medicare and state Medicaid provider number and/or supplier number(s) if any; 15. a description of Life Spine’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and

Implementation Report. Within 120 180 days after the Effective Date, Genova Hill-Rom shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Chief Compliance Officer required by Section III.A, and a summary of other noncompliance job responsibilities the Chief Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.AIII.A.2; 3. the names a copy of the Board members who are responsible for satisfying the Board compliance obligations described in Hill-Rom’s Code of Conduct required by Section III.A.3III.B.1; 4. the names and positions number of the Certifying Employees Covered Persons required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the Code of Conduct certification required by Section III.A.4III.B.1, the percentage of Covered Persons who have completed such certification, and an explanation of any exceptions (the documentation supporting this information shall be available to OIG upon request); 5. the name, business address, business phone number, and position description a summary of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the all Policies and Procedures required by Section III.B (copies of the Policies and a copy of all current order and/or requisition forms in use by GenovaProcedures shall be made available to OIG upon request); 76. the Training Plan required by Section III.C.1 and a description following information regarding each type of the Board training required by Section III.C.2 (III.C: a. a description of such training, including a summary of the topics covered, the length of the trainingsessions, and when a schedule of training sessions; b. the number of Covered Persons required to be trained, percentage of Covered Persons actually trained, and an explanation of any exceptions. A copy of all training was provided)materials and the documentation supporting this information shall be made available to OIG upon request. 7. a description of the Disclosure Program required by Section III.E; 8. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIA; (d) a summary and description of any and all current and prior engagements and agreements between Hill-Rom and the IRO; and (de) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IROHill-Rom; 9. a description of the risk assessment and internal review process required by which Hill-Rom fulfills the requirements of Section III.E; III.F regarding Ineligible Persons; 10. a description list of all of Hill-Rom’s locations, other than those Hill-Rom’s Post Acute Care Division uses as warehouses or repair facilities (including locations and mailing addresses); the Disclosure Program required by Section III.Fcorresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; each location’s Medicare and state Medicaid program provider number and/or supplier number(s); and the name and address of each Medicare and state Medicaid program contractor to which Hill-Rom currently submits claims; 11. a description of Hill-Rom’s corporate structure, including identification of any parent and sister companies, subsidiaries, and their respective lines of business; and 12. the Ineligible Persons screening and removal process certifications required by Section III.G; 12. a copy of Genova’s policies and procedures regarding the identification, quantification and repayment of Overpayments required by Section III.I;V.C.

Implementation Report. Within 120 days after the Effective Date, Genova Mylan shall submit a written report to OIG summarizing the status of its implementation of the requirements of this CIA (Implementation Report). The Implementation Report shall, at a minimum, include: 1. the name, business address, business phone number, and position description of the Compliance Officer required by Section III.AIII.A.1, and a summary of other noncompliance job responsibilities the Compliance Officer may have; 2. the names and positions of the members of the Compliance Committee required by Section III.AIII.A.2; 3. the names of the members of the Board members of Directors who are responsible for satisfying the Board compliance obligations described referenced in Section III.A.3; 4. the names and positions of the Certifying Employees required by Section III.A.4 and a copy of the written process for Certifying Employees to follow in order to complete the certification required by Section III.A.4; 5. the name, business address, business phone number, and position description of the Chief Clinical Officer required by Section III.A.5 ; 6. a list of the Policies and Procedures required by Section III.B and a copy of all current order and/or requisition forms in use by Genova; 7III.B; 6. the Training Plan required by Section III.C.1 and a description of the Board of Directors training required by Section III.C.2 (including a summary of the topics covered, the length of the training, training and when the training was provided); 87. the following information regarding the IRO(s): (a) identity, address, and phone number; (b) a copy of the engagement letter; (c) information to demonstrate that the IRO has the qualifications outlined in Appendix A to this CIAA; and (d) a certification from the IRO regarding its professional independence and objectivity with respect to Genova that includes a summary of all current and prior engagements between Genova and the IROMylan; 98. a description of the risk assessment and internal review process required by Section III.E; 109. a description of the Disclosure Program required by Section III.F; 1110. a description of the Ineligible Persons screening and removal process required by Section III.G; 11. a list of all of Mylan’s locations in the United States (including locations and mailing addresses); the corresponding name under which each location is doing business; the corresponding phone numbers and fax numbers; 12. a copy description of GenovaMylan’s policies corporate structure, including identification of any parent and procedures regarding the identificationsister companies, quantification subsidiaries, and repayment their respective lines of Overpayments required by Section III.I;business; and