Common use of Arrangements Transactions Review Clause in Contracts

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 randomly selected Focus Arrangements that were entered into or renewed by Progenity during the Reporting Period. The IRO shall assess whether Progenity has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in Progenity’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with Progenity’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with Progenity’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity CHN during the Reporting Period. The IRO shall assess whether Progenity CHN has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityCHN’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityCHN’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityCHN’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to CHN and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies CHN and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 randomly selected Focus Arrangements that were entered into or renewed by Progenity Radeas during the Reporting Period. The IRO shall assess whether Progenity Radeas has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityRadeas’s centralized tracking system in a manner that permits the IRO to identify: : (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityRadeas’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityRadeas’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Radeas and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Radeas and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity SPD during the Reporting Period. The IRO shall assess whether Progenity SPD has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenitySPD’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenitySPD’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenitySPD’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to SPD and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies SPD and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO Monitor of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Respironics during the Reporting Period. The IRO Monitor shall assess whether Progenity Respironics has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IROMonitor’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in Progenity’s Respironics’ centralized tracking system in a manner that permits the IRO Monitor to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with Progenity’s Respironics’ policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with Progenity’s Respironics’ policies and procedures;procedures;‌‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO Monitor cannot verify compliance with each of the applicable requirements specified in Section C.1 A.1 above, the IRO Monitor shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO Monitor may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the Monitor cannot verify compliance with each of the applicable requirements specified in Section A.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the Monitor to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the Monitor, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Respironics and OIG an Additional Transactions Review Report that includes the information specified in Section B below, within 60 days of the date the OIG notifies Respironics and its Monitor that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Flower Mound during the Reporting Period. The IRO shall assess whether Progenity Flower Mound has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityFlower Mound’s centralized tracking system in a manner that permits the IRO to identify: : (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually actually‌ provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityFlower Mound’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityFlower Mound’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review‌ Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Flower Mound and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Flower Mound and its IRO that an Additional Transactions Review will be required.‌‌‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 randomly selected Focus Arrangements that were entered into or renewed by Progenity Vision Quest during the Reporting Period. The IRO shall assess whether Progenity Vision Quest has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityVision Quest’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityVision Quest’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityVision Quest’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Vision Quest and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Vision Quest and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 15 (or 20%, whichever is greater) randomly selected Focus Arrangements that were entered into or renewed by Progenity Avanti during the Reporting Period. The IRO shall assess whether Progenity Avanti has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 m.D.1 and III.D.2 m.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s 's assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in Progenity’s Avanti's centralized tracking system in a manner that permits the IRO to identify: identify:‌‌ (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ ' performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; documented;‌ Avanti CIA - Appendix B 3‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with Progenity’s Avanti's policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with Progenity’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.Arrangement;‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity KRMC, HC, and/or NOSM during the Reporting Period. The IRO shall assess whether Progenity KRHS has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityKRHS’s centralized tracking system in a manner that permits the IRO to identify: identify:‌‌ (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) review)‌ and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityKRHS’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityKRHS’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);; and‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to KRHS and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies KRHS and its IRO that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Provider during the Reporting Period. The IRO shall assess whether Progenity Provider has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityProvider’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, ; (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityProvider’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityProvider’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliancecompliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Provider and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Provider and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity GSMC during the Reporting Period. The IRO shall assess whether Progenity GSMC has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityGSMC’s centralized tracking system in a manner that permits the IRO to identify: : (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityGSMC’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityGSMC’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to GSMC and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies GSMC and its IRO that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Paksn during the Reporting Period. The IRO shall assess whether Progenity Paksn has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityPaksn’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityPaksn’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityPaksn’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Paksn and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Paksn and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 100 randomly selected Focus Arrangements that were entered into or renewed by Progenity BioReference during the Reporting Period. The IRO shall assess whether Progenity BioReference has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityBioReference’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityBioReference’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityBioReference’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to BioReference and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies BioReference and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity CRMC during the Reporting Period. The IRO shall assess whether Progenity CRMC has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityCRMC’s centralized tracking system in a manner that permits the IRO to identify: identify:‌‌ (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityCRMC’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityCRMC’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to CRMC and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies CRMC and its IRO that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Post Acute Medical during the Reporting Period. The IRO shall assess whether Progenity Post Acute Medical has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityPost Acute Medical’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityPost Acute Medical’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityPost Acute Medical’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Post Acute Medical and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Post Acute Medical and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Healthquest, Inc. during the Reporting Period. The IRO shall assess whether Progenity Healthquest, Inc. has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 III.E.1 and‌‌ III.E.2 of the CIAIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityHealthquest, Inc.’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityHealthquest, Inc.’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityHealthquest, Inc.’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 III.E.2 of the CIA.IA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-non- compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliancecompliance.‌‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Healthquest, Inc. and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG‌ notifies Healthquest, Inc. and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity APM, Park Center, or Xxxxxx during the Reporting Period. The IRO shall assess whether Progenity has APM, Park Center, and Xxxxxx have complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The Each IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in Progenity’s APM, Park Center, and Xxxxxx’x centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with Progenity’s APM, Park Center, and Xxxxxx’x policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with Progenity’s APM, Park Center, and Xxxxxx’x policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-non- compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO shall be required to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to APM, Park Center, and Xxxxxx and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies APM, Park Center, and Xxxxxx and its IRO that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 randomly selected all of the Focus Arrangements that were entered into or renewed by Progenity OCOM during the Reporting Period. The IRO shall assess whether Progenity OCOM has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityOCOM’s centralized tracking system in a manner that permits the IRO to identify: : (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityOCOM’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityOCOM’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 14 randomly selected Focus Arrangements that were entered into or renewed by Progenity Vascular Access Centers during the Reporting Period. The IRO shall assess whether Progenity Vascular Access Centers has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in Progenity’s Vascular Access Centers’ centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);services‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with Progenity’s Vascular Access Centers’ policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with Progenity’s Vascular Access Centers’ policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO shall be required to select an additional‌ sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Vascular Access Centers and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Vascular Access Centers and its IRO that an Additional Transactions Review will be required.‌‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity CII during the Reporting Period. The IRO shall assess whether Progenity CII has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityCII’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityCII’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityCII’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to CII and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies CII and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity during the Reporting Period. The IRO shall assess whether Progenity Xxxxxxxxx has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections Sections‌‌ III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityNorthwell’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) review)‌ and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityXxxxxxxxx’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityNorthwell’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and medical equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Northwell and OIG an Additional Transactions Review Report that includes the information specified‌ in Section D below, within 60 days of the date the OIG notifies Northwell and its IRO that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Greenway during the Reporting Period. The IRO shall assess whether Progenity Greenway has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 III.E.1 and III.D.2 III.E.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityGreenway’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) review)‌ and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityGreenway’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityGreenway’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 III.E.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require that the IRO select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Greenway and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Greenway and its IRO that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 100 randomly selected Focus Arrangements that were entered into or renewed by Progenity WBH during the Reporting Period. The IRO shall assess whether Progenity WBH has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityWBH’s centralized tracking system in a manner that permits the IRO to identify: identify:‌ (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityWBH’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityWBH’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA.CIA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review‌ Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to WBH and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies WBH and its IRO that an Additional Transactions Review will be required.‌

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Rockport during the Reporting Period. The IRO shall assess whether Progenity Rockport has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 of the CIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityRockport ’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e.i.e, items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.); b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented; c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityRockport ’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement; d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityRockport ’s policies and procedures; e. verifying that the service and activity logs are properly completed and reviewed (if applicable); f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); and g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 of the CIA. 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance. 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Rockport and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Rockport and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Provider during the Reporting Period. The IRO shall assess whether Progenity Provider has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 III.E.1 and III.D.2 III.E.2 of the CIAIA, with respect to the selected Focus Arrangements.Arrangements.‌ 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityProvider’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityProvider’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityProvider’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 III.E.2 of the CIA.IA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliancecompliance.‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review‌ (Additional Transactions Review) and complete and submit to Provider and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Provider and its IRO that an Additional Transactions Review will be required.

Arrangements Transactions Review. The Arrangements Transactions Review shall consist of a review by the IRO of 25 50 randomly selected Focus Arrangements that were entered into or renewed by Progenity Healthquest, Inc. during the Reporting Period. The IRO shall assess whether Progenity Healthquest, Inc. has complied with the Focus Arrangements Procedures and the Focus Arrangements Requirements described in Sections III.D.1 and III.D.2 III.E.1 and‌‌ III.E.2 of the CIAIA, with respect to the selected Focus Arrangements. 1. The IRO’s assessment with respect to each Focus Arrangement that is subject to review shall include: a. verifying that the Focus Arrangement is maintained in ProgenityHealthquest, Inc.’s centralized tracking system in a manner that permits the IRO to identify: (i) the parties to the Focus Arrangement, (ii) the name(s) and position(s) of the Arrangements Covered Person(s) involved in the negotiation, review, and approval of the Focus Arrangement; (iii) the relevant terms of the Focus Arrangement (i.e., the items, services, equipment, or space to be provided, the amount of compensation, the effective date, the expiration date, etc.); and (iv) the parties’ performance under the Focus Arrangement (i.e., items or services actually provided, equipment or space actually provided or leased, amount of payments, dates of payment, etc.);etc.);‌‌ b. verifying that the Focus Arrangement was subject to the internal review and approval process (including both a legal and business review) and obtained the necessary approvals and that such review and approval is appropriately documented;documented;‌ c. verifying that the remuneration related to the Focus Arrangement has been determined in accordance with ProgenityHealthquest, Inc.’s policies and procedures for determining and documenting the fair market value of the remuneration, that the remuneration is properly tracked, and that the parties to the Focus Arrangement are complying with the financial terms of the Focus Arrangement;Arrangement;‌ d. verifying that the business need or business rationale for the Focus Arrangement is specified and is consistent with ProgenityHealthquest, Inc.’s policies and procedures;procedures;‌ e. verifying that the service and activity logs are properly completed and reviewed (if applicable);applicable);‌ f. verifying that leased space, medical supplies, medical devices, and equipment, and other patient care items are properly monitored (if applicable); andand‌ g. verifying that the Focus Arrangement satisfies the Focus Arrangements Requirements of Section III.D.2 III.E.2 of the CIA.IA.‌ 2. For any Focus Arrangement for which the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above, the IRO shall identify and review the system(s) and process(es) that resulted in the identified non-non- compliance and recommend improvements to such system(s) and process(es). The IRO may need to review additional documentation and/or interview personnel to identify the system(s) and process(es) that resulted in the identified non-compliance.compliance.‌‌ 3. If the IRO cannot verify compliance with each of the applicable requirements specified in Section C.1 above with respect to at least 90% of the Focus Arrangements subject to the Arrangements Transactions Review, then, at its discretion, within 60 days of receipt of the Arrangements Transactions Review Report, the OIG may require the IRO to select an additional sample of Focus Arrangements, not to exceed the number of Focus Arrangements initially reviewed by the IRO, that will be subject to the Arrangements Transactions Review (Additional Transactions Review) and complete and submit to Healthquest, Inc. and OIG an Additional Transactions Review Report that includes the information specified in Section D below, within 60 days of the date the OIG notifies Healthquest, Inc. and its IRO that an Additional Transactions Review will be required.‌