Common use of EFFECTIVE AND BINDING AGREEMENT Clause in Contracts

EFFECTIVE AND BINDING AGREEMENT. Provider and OMIG agree as follows: A. Good and valuable consideration has been exchanged between the parties to this CIA. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA as established in Section II. A. C. This CIA shall be considered to include the Corporate Integrity Agreement and any Appendix, Attachment or Amendment to this CIA which is in writing and executed by the parties to this CIA. They shall collectively constitute the entire and complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA, or as may be otherwise permitted. D. The terms of any Appendix, Attachment or Amendment to the CIA shall be incorporated by reference as if fully set forth in this CIA. If there is any conflict between a term in the CIA and any Appendix, Attachment or Amendment, the terms of the CIA shall control unless otherwise specifically stated in the terms of the Appendix, Attachment or Amendment. E. This CIA shall be binding on the successors, assigns, and transferees of Provider. F. All requirements and remedies set forth in this CIA are in addition to, and do not effect: 1. Provider’s responsibility to follow all applicable New York State and Federal health care program requirements or 2. the State of New York’s or the federal government’s right to impose appropriate remedies for failure to follow applicable program requirements. G. The undersigned Provider signatories represent and warrant that they are authorized to execute this CIA. The undersigned OMIG signatory represents that he/she is signing this CIA in his/her official capacity and that he/she is authorized to execute this CIA. H. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA.

EFFECTIVE AND BINDING AGREEMENT. Provider Arthrex and OMIG OIG agree as follows: A. Good and valuable consideration has been exchanged between the parties to this CIA. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA as established in Section II. A.CIA. C. B. This CIA shall be considered to include constitutes the Corporate Integrity Agreement and any Appendix, Attachment or Amendment to this CIA which is in writing and executed by the parties to this CIA. They shall collectively constitute the entire and complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA, or as may be otherwise permitted. D. The terms of any Appendix, Attachment or Amendment to the CIA shall be incorporated by reference as if fully set forth in this CIA. If there is any conflict between a term in the CIA and any Appendix, Attachment or Amendment, the terms of the CIA shall control unless otherwise specifically stated in the terms of the Appendix, Attachment or Amendment. E. This CIA shall be binding on the successors, assigns, and transferees of Provider. F. C. All requirements and remedies set forth in this CIA are in addition to, to and do not effect: affect (1. Provider) Arthrex’s responsibility to follow all applicable New York State and Federal health care program and FDA requirements or or (2. ) the State of New York’s or the federal government’s right to impose appropriate remedies for failure to follow applicable Federal health care program or FDA requirements. G. D. The undersigned Provider Arthrex signatories represent and warrant that they are authorized to execute this CIA. The undersigned OMIG signatory represents OIG signatories represent that he/she is they are signing this CIA in his/her their official capacity and that he/she is they are authorized to execute this CIA. H. E. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Facsimiles of Electronically-transmitted signatures shall constitute acceptable, binding signatures for purposes of this CIA. APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.E of the CIA. A. IRO Engagement‌ 1. Arthrex shall engage an IRO that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the review in a professionally independent and objective fashion, as set forth in Paragraph E. Within 30 days after OIG receives the information identified in Section V.A.8 of the CIA or any additional information submitted by Arthrex in response to a request by OIG, whichever is later, OIG will notify Arthrex if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Arthrex may continue to engage the IRO.‌ 2. If Arthrex engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Arthrex shall submit the information identified in Section V.A.8 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Arthrex at the request of OIG, whichever is later, OIG will notify Arthrex if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Arthrex may continue to engage the IRO.‌ B. IRO Qualifications The IRO shall:‌‌ 1. assign individuals to conduct the IRO Reviews who have expertise in the medical device industry and in all applicable Federal health care program and FDA requirements relating to the Covered Functions, including but not limited to expertise relating to marketing and promotional activities associated with medical devices and the Federal Anti-Kickback Statute and False Claims Act.‌ 2. assign individuals to design and select the samples for the IRO Transactions Review who are knowledgeable about the appropriate statistical sampling techniques; and‌ 3. have sufficient staff and resources to conduct the reviews required by the CIA on a timely basis.‌ C. IRO Responsibilities The IRO shall:‌‌‌ 1. perform each component of the IRO Reviews in accordance with the specific requirements of the CIA;‌ 2. follow all applicable Federal health care program and FDA requirements in making assessments in the IRO Reviews;‌ 3. respond to all OIG inquires in a prompt, objective, and factual manner; and 4. prepare timely, clear, well-written reports that include all the information required by Appendix B to the CIA. D. Arthrex Responsibilities‌ Arthrex shall ensure that the IRO has access to all records and personnel necessary to complete the reviews listed in III.E of this CIA and that all records furnished to the IRO are accurate and complete.

EFFECTIVE AND BINDING AGREEMENT. Provider ‌ Greenway and OMIG OIG agree as follows: A. Good and valuable consideration has been exchanged between the parties to this CIA. B. This CIA shall become final and binding on the date the final signature is obtained on the CIA as established in Section II. A.CIA. C. B. This CIA shall be considered to include constitutes the Corporate Integrity Agreement and any Appendix, Attachment or Amendment to this CIA which is in writing and executed by the parties to this CIA. They shall collectively constitute the entire and complete agreement between the parties and may not be amended except by prior written consent of the parties to this CIA. C. OIG may agree to a suspension of Greenway’s obligations under this CIA based on a certification by Greenway that it is no longer providing health care items or services that will be billed to any Federal health care program, including payment programs involving the use of health information technology, and that it does not have any ownership or control interest, as defined in 42 U.S.C. § 1320a-3, in any entity that bills any Federal health care program. If Greenway is relieved of its CIA obligations, Greenway will be required to notify OIG in writing at least 30 days in advance if Greenway plans to resume providing health care items or services that are billed to any Federal health care program, including payment programs involving the use of health information technology, or as may to obtain an ownership or control interest in any entity that bills any Federal health care program. At such time, OIG shall evaluate whether the CIA will be otherwise permittedreactivated or modified. D. The terms of any Appendix, Attachment or Amendment to the CIA shall be incorporated by reference as if fully set forth in this CIA. If there is any conflict between a term in the CIA and any Appendix, Attachment or Amendment, the terms of the CIA shall control unless otherwise specifically stated in the terms of the Appendix, Attachment or Amendment. E. This CIA shall be binding on the successors, assigns, and transferees of Provider. F. All requirements and remedies set forth in this CIA are in addition to, to and do not effect: affect (1. Provider) Greenway’s responsibility to follow all applicable New York State and Federal health care program requirements, including the requirements or of the payment programs involving the use of health information technology and the regulations and other guidance related to these programs, and ONC Health IT Certification Program requirements or (2. ) the State of New York’s or the federal government’s right to impose appropriate remedies for failure to follow applicable Federal health care program requirements., including the requirements of the payment programs involving the use of health information technology and the regulations and other guidance related to these programs, and ONC Health IT Certification Program requirements.‌ G. E. The undersigned Provider Greenway signatories represent and warrant that they are authorized to execute this CIA. The undersigned OMIG signatory represents OIG signatories represent that he/she is they are signing this CIA in his/her their official capacity capacities and that he/she is they are authorized to execute this CIA. H. F. This CIA may be executed in counterparts, each of which constitutes an original and all of which constitute one and the same CIA. Facsimiles of signatures shall constitute acceptable, binding signatures for purposes of this CIA. ON BEHALF OF GREENWAY HEALTH, LLC‌ /Xxxxxxx Xxxxx/ XXXXXXX XXXXX Chief Executive Officer Greenway Health, LLC DATE Xxxxxxx Xxxxxx Counsel for Greenway Health, LLC DATE ON BEHALF OF THE OFFICE OF INSPECTOR GENERAL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES‌ XXXX X. RE DATE Assistant Inspector General for Legal Affairs Office of Inspector General U. S. Department of Health and Human Services XXXX X. X’XXXXX DATE Senior Counsel Office of Inspector General U. S. Department of Health and Human Services APPENDIX A INDEPENDENT REVIEW ORGANIZATION‌‌ This Appendix contains the requirements relating to the Independent Review Organization (IRO) required by Section III.F of the CIA. A. IRO Engagement‌ 1. Greenway shall engage an IRO to perform the Software Review that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall conduct the Software Review in a professionally independent and objective fashion, as set forth in Paragraph E.‌ 2. Greenway shall engage an IRO to perform the Arrangements Review that possesses the qualifications set forth in Paragraph B, below, to perform the responsibilities in Paragraph C, below. The IRO shall not have a prohibited relationship to Greenway as set forth in Paragraph F.‌ 3. Within 30 days after OIG receives the information identified in Section‌ V.A.12 of the CIA or any additional information submitted by Greenway in response to a request by OIG, whichever is later, OIG will notify Greenway if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Greenway may continue to engage the IRO. 4. If Greenway engages a new IRO during the term of the CIA, that IRO must also meet the requirements of this Appendix. If a new IRO is engaged, Greenway shall submit the information identified in Section V.A.12 of the CIA to OIG within 30 days of engagement of the IRO. Within 30 days after OIG receives this information or any additional information submitted by Greenway at the request of OIG, whichever is later, OIG will notify Greenway if the IRO is unacceptable. Absent notification from OIG that the IRO is unacceptable, Greenway may continue to engage the IRO.