Common use of ERM Transactions Review Clause in Contracts

ERM Transactions Review. A. At least thirty (30) days prior to the end of the first through fifth Reporting Periods, Baxano Surgical shall submit to OIG a list of all Baxano Surgical Government Reimbursed Products for which RMPs were developed. Baxano Surgical shall notify the OIG about which products had Standard RMPs and which products had Enhanced RMPs. Prior to the end of the applicable Reporting Period, OIG shall select up to 3 Baxano Surgical Government Reimbursed Products (each a “Selected Product” and together the “Selected Products”) to be reviewed in connection with the ERM Transactions Review. B. For each Reporting Period and for each Selected Product, the IRO shall conduct a review of: i) the applicable Risk Evaluation Report entry and RMP; ii) documents and materials related to the development of the RMP; and iii) documents and materials relating to the implementation of the RMP. The IRO shall also interview the individual(s) responsible for the development of the RMP and the individual(s) responsible for the implementation of the risk monitoring and risk mitigation activities specified in the RMP. The objective of the IRO shall be to: (i) understand the processes followed by Baxano Surgical in developing the RMP for each Selected Product, including the underlying bases for Baxano Surgical’s decision to develop either a Standard RMP or an Enhanced RMP for the Selected Product; (ii) determine whether, based on the information contained in the Risk Evaluation Report, an appropriate RMP (including as to the included risk monitoring activities, risk mitigation activities, and risk mitigation action items) was developed for the Selected Product; and (iii) assess Baxano Surgical’s implementation and tracking of the implementation of the RMP for the Selected Product. C. The IRO will prepare a report based on each ERM Transactions Review performed (ERM Transaction Review Report). The Transactions Review Report shall include the following: 1. an identification of the Selected Products and a description of the documents and information reviewed in connection with each Selected Product, including a description of whether the RMP for each Selected Product was a Standard RMP or an Enhanced RMP; 2. for each Selected Product, a description of: i) the process followed in developing the RMP; and ii) the types of identified risks associated with the Selected Product;

ERM Transactions Review. A. At least thirty (30) days prior to the end of the first through fifth Reporting Periods, Baxano Surgical Par shall submit to OIG a list of all Baxano Surgical Par Relevant Government Reimbursed Products for which RMPs were developed. Baxano Surgical Par shall notify the OIG about which products had Standard RMPs and which products had Enhanced RMPs. Prior to the end of the applicable Reporting Period, OIG shall select up to 3 Baxano Surgical Par Relevant Government Reimbursed Products (each a “Selected Product” and together the “Selected Products”) to be reviewed in connection with the ERM Transactions Review. B. For each Reporting Period and for each Selected Product, the IRO shall conduct a review of: i) the applicable Risk Evaluation Report entry and RMP; ii) documents and materials related to the development of the RMP; and iii) documents and materials relating to the implementation of the RMP. The IRO shall also interview the individual(s) responsible for the development of the RMP and the individual(s) responsible for the implementation of the risk monitoring and risk mitigation activities specified in the RMP. The objective of the IRO shall be to: (i) understand the processes followed by Baxano Surgical Par in developing the RMP for each Selected Product, including the underlying bases for Baxano SurgicalPar’s decision to develop either a Standard RMP or an Enhanced RMP for the Selected Product; (ii) determine whether, based on the information contained in the Risk Evaluation Report, an appropriate RMP (including as to the included risk monitoring activities, risk mitigation activities, and risk mitigation action items) was developed for the Selected Product; and (iii) assess Baxano SurgicalPar’s implementation and tracking of the implementation of the RMP for the Selected Product. C. The IRO will prepare a report based on each ERM Transactions Review performed (ERM Transaction Review Report). The Transactions Review Report shall include the following: 1. an identification of the Selected Products and a description of the documents and information reviewed in connection with each Selected Product, including a description of whether the RMP for each Selected Product was a Standard RMP or an Enhanced RMP; 2. for each Selected Product, a description of: i) the process followed in developing the RMP; and ii) the types of identified risks associated with the Selected Product; 3. for each Selected Product, an assessment of whether it was appropriate for Par to develop, as applicable, an Enhanced or a Standard, RMP for the product; 4. for each Selected Product, an assessment of whether, based on the information contained in the Risk Evaluation Report, an appropriate RMP was developed for the Selected Product; 5. for each Selected Product, a description of the expertise and backgrounds of the individuals who were responsible for the development of the RMP; 6. for each Selected Product, a description of the following items set forth in the RMP: (i) risk monitoring activities; (ii) metrics by which the risk monitoring activities and results will be evaluated and/or measured; (iii) risk mitigation activities, including any risk mitigation action items; (iv) metrics by which the risk mitigation activities and results will be evaluated and/or measured; (v) responsible individual(s); (vi) expected date(s) of completion for each risk monitoring activity and risk mitigation activity; and (vii) if the RMP did not specify each of the items set forth above, a description of any deficiencies; 7. for each Selected Product, a description of whether risk monitoring activities specified in the RMP were implemented and tracked in accordance with the RMP and Par’s policies and procedures, and a description of any deficiencies; 8. for each Selected Product, a description of whether risk mitigation activities (including any action items) specified in the RMP were implemented and tracked in accordance with the RMP and Par’s policies and procedures, and a description of any deficiencies; 9. for each Selected Product a description of: (i) any recommendations made by the IRO regarding the RMP or any risk monitoring activities and risk mitigation activities included in the RMP; (ii) whether, and in what manner, Par implemented the recommendations from the IRO; and