Common use of OIG Removal of IRO Clause in Contracts

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the final determination as to whether or not to require GSK to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph DE or has a prohibited relationship as set forth in paragraph F (as applicable), or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Progenity in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Progenity shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence, relationship to Progenity or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Progenity regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Progenity in writing that Progenity shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Progenity must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Progenity to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Progenity’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Progenity materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK J&J and/or the J&J Pharmaceutical Affiliates to engage a new IRO in accordance with Paragraph A of this Appendix. GSK J&J and/or the J&J Pharmaceutical Affiliates must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK J&J and/or the J&J Pharmaceutical Affiliates to engage a new IRO, OIG shall notify GSK J&J and/or the J&J Pharmaceutical Affiliates of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK J&J and/or the J&J Pharmaceutical Affiliates may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK J&J and/or the J&J Pharmaceutical Affiliates prior to requiring GSK J&J and/or the J&J Pharmaceutical Affiliates to terminate the IRO. However, the final determination as to whether or not to require GSK J&J and/or the J&J Pharmaceutical Affiliates to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) J&J and/or the J&J Pharmaceutical Affiliates shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK the J&J Pharmaceutical Affiliates in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO the Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK J&J and/or the J&J Pharmaceutical Affiliates may engage, at its their discretion, a single IRO to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s the applicable systems, processes, policies, and procedures of the J&J Pharmaceutical Affiliates relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO Reporting Periods. If GSK the J&J Pharmaceutical Affiliate materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK CHSI to engage a new IRO in accordance with Paragraph A of this Appendix. GSK CHSI must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK CHSI to engage a new IRO, OIG shall notify GSK CHSI of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK CHSI may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK CHSI prior to requiring GSK CHSI to terminate the IRO. However, the final determination as to whether or not to require GSK CHSI to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Community Health Systems, Inc. 3 Corporate Integrity Agreement - Appendix A A. Inpatient Medical Necessity and Appropriateness Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO shall perform the Inpatient Medical Necessity and Appropriateness Review annually to cover each of the five Reporting Periods. The IRO shall perform all components of each Inpatient Medical Necessity and Appropriateness Review. The Inpatient Medical Necessity and Appropriateness Review shall be conducted at 7.5% of CHSI’s Covered Facilities for each Reporting Period. Each Inpatient Medical Necessity and Appropriateness Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of all the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changedfollowing. The IRO shall conduct evaluate and analyze CHSI’s inpatient admissions, relevant length of stays, associated billing, and claims submissions to Federal health care programs and the Transactions reimbursement received, and determine if such admissions and lengths of stays (as identified in Section A.2.b of Appendix B) were medically necessary and appropriate under the applicable Federal health care program rules and regulations governing inpatient admission, treatment, discharge, billing, and reimbursement. The Inpatient Medical Necessity and Appropriateness Review shall include a Discovery Sample and, if necessary, a Full Sample for each IRO Reporting Period of the CIA.CHSI Covered Facility reviewed. The review shall be performed as follows:

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify PCMC in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. PCMC shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by PCMC regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify PCMC in writing that PCMC shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK PCMC must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK PCMC to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW‌‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto PCMC’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If PCMC materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Paksn in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Paksn shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Paksn regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Paksn in writing that Paksn shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Paksn must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Paksn to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - a systems review (Systems Review) Review and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKto Paksn’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Paksn materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Xxxxx in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Xxxxx shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Xxxxx regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Xxxxx in writing that Xxxxx shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Xxxxx must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Xxxxx to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌ APPENDIX B ARRANGEMENTS REVIEW‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSK’s to Xxxxx’x systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Xxxxx materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Primex in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Primex shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Primex regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Primex in writing that Primex shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Primex must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Primex to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Primex’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Primex materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify SPD in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. SPD shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by SPD regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify SPD in writing that SPD shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK SPD must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK SPD to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto SPD’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If SPD materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify KRHS in writing regarding OIG’s basis for determining‌ that the IRO has not met the requirements of this Appendix. KRHS shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by KRHS regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify KRHS in writing that KRHS shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK KRHS must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK KRHS to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Arrangements Systems Review) and a transactions review (Arrangement Transactions Review) as described more fully below). GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto KRHS’s systems, processes, policies, and procedures relating to the Covered IRO FunctionsArrangements, the IRO shall perform the Arrangements Systems Review shall be performed for the second first and fifth IRO fourth Reporting Periods. If GSK KRHS materially changes its change the Arrangements systems, processes, policies, and procedures relating to the Covered IRO Functionsprocedures, the IRO shall perform a an Arrangements Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify BioReference in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. BioReference shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by BioReference regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify BioReference in writing that BioReference shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK BioReference must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK BioReference to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - a systems review (Systems Review) Review and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKto BioReference’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If BioReference materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Lilly to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Lilly to engage a new IRO, OIG shall notify GSK Lilly of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Lilly may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Lilly shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Lilly prior to requiring GSK Lilly to terminate the IRO. However, the final determination as to whether or not to require GSK Lilly to engage a new IRO shall be made at the sole discretion of OIG. Appendix A Xxx Xxxxx CIA I. Covered Functions Promotional and Product Services Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Lilly shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Lilly in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Lilly’s Promotional and Product Services Related Functions (collectively, “IRO Covered Functions”Promotional and Product Services Review). The IRO Promotional and Product Services Review shall consist of two components - a systems review (the “Promotional and Product Services Systems Review) ” or “Systems Review”), and a transactions review (the “Promotional and Product Services Transactions Review” or “Transactions Review”) as described more fully below. GSK Lilly may engage, at its discretion, a single IRO to perform both components of the IRO Promotional and Product Services Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKLilly’s systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform the Promotional and Product Services Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Lilly materially changes its systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform a Promotional and Product Services Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Promotional and Product Services Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Par to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Par must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Par to engage a new IRO, OIG shall notify GSK Par of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Par may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Par prior to requiring GSK Par to terminate the IRO. However, the final determination as to whether or not to require GSK Par to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX B TO CIA FOR PAR INDEPENDENT REVIEW ORGANIZATION REVIEWS I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. (GSKcollectively, Par) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Par in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSKPar's Covered Functions (collectively, “IRO Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Par may engage, at its discretion, a single IRO to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKPar’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Par materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Vision Quest in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Vision Quest shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship to Vision Quest or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Vision Quest regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Vision Quest in writing that Vision Quest shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Vision Quest must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Vision Quest to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - a systems review (Systems Review) Review and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKto Vision Quest’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Vision Quest materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph DE or has a prohibited relationship as set forth in‌ paragraph F (as applicable), or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Greenway in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Greenway shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence, relationship to Greenway or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Greenway regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Greenway in writing that Greenway shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Greenway must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Greenway to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Greenway’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Greenway materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Cordant in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Cordant shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Cordant regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Cordant in writing that Cordant shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Cordant must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Cordant to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Cordant’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Cordant materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Spectranetics to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Spectranetics Corporate Integrity Agreement Prior to requiring GSK Spectranetics to engage a new IRO, OIG shall notify GSK Spectranetics of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Spectranetics may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Spectranetics shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Spectranetics prior to requiring GSK Spectranetics to terminate the IRO. However, the final determination as to whether or not to require GSK Spectranetics to engage a new IRO shall be made at the sole discretion of OIG. Spectranetics Corporate Integrity Agreement I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Spectranetics shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Spectranetics in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Spectranetics’s Clinical Investigation Related Functions, Reporting Related Functions, and Promotional and Product Services Related Functions (collectively, “IRO Covered Functions”Review). The IRO Review shall consist of two components - — a systems review (Systems Review) ), and a transactions review (Transactions Review) as described more fully below. GSK Spectranetics may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKSpectranetics’s systems, processes, policies, and procedures relating to the Covered IRO Clinical Investigations, Reporting, and Promotional and Product Services Related Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Spectranetics materially changes its systems, processes, policies, and procedures relating to the Covered IRO Clinical Investigation Related Functions, Reporting Related Functions, and Promotional and/or Product Services Related Functions, the IRO shall perform a Systems Review for the IRO materially changed Related Function for the Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, of this Appendix, is not independent and/or and objective as set forth in Paragraph DE, of this Appendix, or has failed to carry out its responsibilities as described in Paragraph CD, of this Appendix, OIG may, at its sole discretion, require GSK Exactech to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Exactech, Inc. - Appendix A Prior to requiring GSK Exactech to engage a new IRO, OIG shall notify GSK Exactech of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Exactech may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Exactech shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Exactech prior to requiring GSK Exactech to terminate the IRO. However, the final determination as to whether or not to require GSK Exactech to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions ReviewExactech, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). Inc. - Appendix A APPENDIX B ARRANGEMENTS REVIEW The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Exactech’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the second and fourth Reporting Periods. If Exactech materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify OCOM in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. OCOM shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by OCOM regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify OCOM in writing that OCOM shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK OCOM must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK OCOM to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto OCOM’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the second and fourth Reporting Periods. If OCOM materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify CRMC in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. CRMC shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by CRMC regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify CRMC in writing that CRMC shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK CRMC must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK CRMC to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌‌‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto CRMC’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If CRMC materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Insys in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Insys shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Insys regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Insys in writing that Insys shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Insys must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Insys to engage a new IRO shall be made at the sole discretion of OIG. OIG.‌ I. Covered Functions Review, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) Insys shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Insys in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO the Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Insys may engage, at its discretion, a single IRO to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s the applicable systems, processes, policies, and procedures of Insys relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Insys materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA. II. Systems Review‌

OIG Removal of IRO. In the event OIG has reason to believe that the IRO (including the Legal Reviewer(s)) does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, E or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify PSI in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. PSI shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by PSI regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify PSI in writing that PSI shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK PSI must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK PSI to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions ReviewOIG.‌ Appendix B‌‌ A. IRO Engagement, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) PSI shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) engagements to assist GSK PSI in assessing and evaluating its systems, processes, policies, procedures, and practices procedures related to certain of GSK's Covered Patient Assistance Related Functions as defined in the IA (collectivelyIRO Reviews). Each review shall be performed with respect to the applicable Reporting Period. More specifically, “for the first Reporting Period, the IRO Covered Functions”)Review shall cover calendar year 2020. For the second and third Reporting Periods, the IRO Reviews shall cover calendar years 2021 and 2022, respectively. The IRO Review Reviews shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK PSI may engage, at its discretion, a single IRO entity to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKPSI’s systems, processes, policies, and procedures relating to the Covered IRO Patient Assistance Related Functions, the IRO shall perform the Systems Review outlined below for the second first and fifth IRO third Reporting Periods. If GSK PSI materially changes its systems, processes, policies, and procedures relating to the Covered IRO Patient Assistance Related Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such material changes were made in addition to conducting the Review below for the second first and fifth IRO third Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIAthree Reporting Periods of the IA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Provider in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Provider shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review‌ of any information provided by Provider regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Provider in writing that Provider shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Provider must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Provider to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) Review and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKto Provider’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and third Reporting Periods. If Provider materially changes the Arrangements systems, processes, policies and procedures during the second Reporting Period, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made Period in addition to conducting the Review systems review for the second first and fifth IRO third Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO three Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK ICH to engage a new IRO in accordance with Paragraph A of this Appendix. GSK ICH must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK ICH to engage a new IRO, OIG shall notify GSK ICH of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK ICH may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK ICH prior to requiring GSK ICH to terminate the IRO. However, the final determination as to whether or not to require GSK ICH to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto ICH’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If ICH materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK TCH to engage a new IRO in accordance with Paragraph A of this Appendix. GSK TCH must engage a new IRO within 60 days of termination of the IROprior IRO or at least 60 days prior to the end of the current Reporting Period, whichever is earlier. Prior to requiring GSK TCH to engage a new IRO, OIG shall notify GSK TCH of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK TCH may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK TCH prior to requiring GSK TCH to terminate the IRO. However, the final determination as to whether or not to require GSK TCH to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto TCH’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If TCH materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify ResMed in writing regarding OIG’s basis for determining‌ that the IRO has not met the requirements of this Appendix. ResMed shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by ResMed regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify ResMed in writing that ResMed shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK ResMed must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK ResMed to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto ResMed’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If ResMed materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph DE or has a prohibited relationship as set forth in paragraph F (as applicable), or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Prime in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Prime shall have 30 days‌ from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence, relationship to Prime or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Prime regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Prime in writing that Prime shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Appendix.‌ Prime must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Prime to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Prime’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Prime materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify HealthNet in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. HealthNet shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by HealthNet regarding the IRO, OIG determines that the IRO has not met the‌ requirements of this Appendix, OIG shall notify HealthNet in writing that HealthNet shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK HealthNet must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK HealthNet to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto HealthNet’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If HealthNet materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK SpecialCare to engage a new IRO in accordance with Paragraph A of this Appendix. GSK SpecialCare must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK SpecialCare to engage a new IRO, OIG shall notify GSK SpecialCare of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK SpecialCare may present additional information regarding the IRO’s qualifications, independence independence, or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK SpecialCare prior to requiring GSK SpecialCare to terminate the IRO. However, the final determination as to whether or not to require GSK SpecialCare to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto SpecialCare’s systems, processes, policies, and procedures relating to the Covered IRO FunctionsArrangements, the IRO shall perform the Arrangements Systems Review shall be performed for the second first and fifth IRO fourth Reporting Periods. If GSK SpecialCare materially changes its the Arrangements systems, processes, policies, and procedures relating to the Covered IRO Functionsprocedures, the IRO shall perform a an Arrangements Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Elan to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Elan to engage a new IRO, OIG shall notify GSK Elan of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Elan may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Elan shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Elan prior to requiring GSK Elan to terminate the IRO. However, the final determination as to whether or not to require GSK Elan to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Elan shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Elan in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Government Pricing and Contracting Functions (collectivelyas defined in Section II.C.4 of the CIA), its Medical Affairs and Materials Related Functions (as defined in Section II.C.5 of the CIA), and its funding of educational grants and healthcare related charitable contributions (as discussed below in Section III.A) (collectively “IRO Covered FunctionsReviews”). The IRO Review shall consist of two components - — a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Elan may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If If, during the term of the CIA, there are no material changes in GSKElan’s systems, processes, policies, and procedures relating to the Covered IRO Government Pricing and Contracting Functions or to Medical Affairs and Materials Related Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Elan materially changes its systems, processes, policies, and procedures relating to the Covered IRO Government Pricing and Contracting Functions or to Medical Affairs or Materials Related Functions, the IRO shall perform a Systems Review for the IRO materially changed Function for the Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Mercy in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Mercy shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Mercy regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Mercy in writing that Mercy shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Xxxxx must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Mercy to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Mercy’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Mercy materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Atricure, Inc. to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Atricure, Inc. to engage a new IRO, OIG shall notify GSK Atricure, Inc. of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Atricure, Inc. may present additional information regarding request a Appendix A Atricure, Inc. CIA meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Atricure, Inc. shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Atricure, Inc. prior to requiring GSK Atricure, Inc. to terminate the IRO. However, the final determination as to whether or not to require GSK Atricure, Inc. to engage a new IRO shall be made at the sole discretion of OIG. Appendix A Atricure, Inc. CIA I. Covered Functions Promotional and Product Services Review, General Description As specified more fully below, GlaxoSmithKline AtriCure, Inc. (GSKAtriCure) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK AtriCure in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered AtriCure’s Promotional and Product Services Related Functions (collectively, “IRO Covered Functions”Promotional and Product Services Review). The IRO Promotional and Product Services Review shall consist of two components - a systems review (the “Promotional and Product Services Systems Review) ” or “Systems Review”), and a transactions review (the “Promotional and Product Services Transactions Review” or “Transactions Review”) as described more fully below. GSK AtriCure may engage, at its discretion, a single IRO to perform both components of the IRO Promotional and Product Services Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKAtriCure’s systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform the Promotional and Product Services Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK AtriCure materially changes its systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform a Promotional and Product Services Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Promotional and Product Services Transactions Review for each IRO Reporting Period of the CIA. II. Promotional and Product Services Systems Review A. Description of Reviewed Policies and Procedures The Promotional and Product Services Systems Review shall be a review of AtriCure’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to certain Promotional and Product Services Related Functions. Where practical, AtriCure personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not Appendix B AtriCure, Inc. required to undertake a de novo review of the information gathered or activities undertaken by AtriCure pursuant to the preceding sentence. Specifically, the IRO shall review AtriCure’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”): 1) AtriCure’s systems, policies, processes, and procedures applicable to the manner in which AtriCure representatives (including sales representatives and marketing personnel) handle requests or inquiries relating to information about the uses of AtriCure products (including non-FDA-approved (i.e., off-label) uses) and the dissemination of materials relating to off-label uses of products. This review includes: a) the manner in which AtriCure sales representatives and marketing personnel handle requests for information about off-label uses of AtriCure products; b) the form and content of information and materials related to AtriCure’s products disseminated to physicians, pharmacists, or other health care professionals (collectively “HCPs”) or health care institutions (“HCIs”) by AtriCure; c) AtriCure’s systems, processes, and procedures (including the Inquiries Database) to track requests for information about off-label uses of products and responses to those requests; d) the manner in which AtriCure collects and supports information reported in any systems used to track and respond to requests for product information, including its Inquiries Database; e) the processes and procedures by which the Compliance Officer (and other appropriate individuals within AtriCure) identify situations in which it appears that improper off-label promotion may have occurred; and f) AtriCure’s processes and procedures for investigating, documenting, resolving, and taking appropriate disciplinary action for potential situations involving off-label promotion; 2) AtriCure’s systems, policies, processes, and procedures relating to AtriCure’s internal review and approval of information and Appendix B AtriCure, Inc. materials related to AtriCure’s products disseminated to HCPs or HCIs by AtriCure; 3) AtriCure’s systems, polices, processes and procedures relating to incentive compensation for Covered Persons who are sales representatives, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in the improper promotion, sales, and marketing of AtriCure’s products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance; 4) AtriCure’s systems, policies, processes and procedures relating to its efforts to obtain FDA-required approvals for its Government Reimbursed Products; and 5) AtriCure’s systems, processes, policies, and procedures relating to the development and review of launch and marketing plans for AtriCure’s products. This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, AtriCure’s launch and marketing plans based on expected utilization of AtriCure products for FDA-approved uses or non-FDA-approved uses.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Healthquest, at Inc. in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Healthquest, Inc. shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Healthquest, Inc. regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Healthquest, Inc. in writing that Healthquest, Inc. shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Healthquest, Inc. must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Healthquest, Inc. to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌ APPENDIX B ARRANGEMENTS REVIEW‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Healthquest, Inc.’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Healthquest, Inc. materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, E or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Biotronik in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Biotronik shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Biotronik regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Biotronik in writing that‌ Biotronik shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Biotronik must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Biotronik to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) The IRO shall retain an Independent perform a Systems Review Organization (IRO) (or IROs) and a Transactions Review relating to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's the Covered Functions (collectively, “IRO Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components defined in Section II.C of the IRO Review provided that the entity has the necessary expertise and capabilities to perform bothCIA). If there are no material changes in GSKBiotronik’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Biotronik materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a an additional Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of that identifies the material changes; 2) an assessment of whether other systems, processes, policies, changes and procedures previously reported did not materially change; and 3) a review of reviews the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, of this Appendix, is not independent and/or and objective as set forth in Paragraph DE, of this Appendix, or has failed to carry out its responsibilities as described in Paragraph CD, of this Appendix, OIG may, at its sole discretion, require GSK Xxxxxx to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Xxxxxx Medical Technology, Inc. — Appendix A Prior to requiring GSK Xxxxxx to engage a new IRO, OIG shall notify GSK Xxxxxx of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Xxxxxx may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Xxxxxx shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Xxxxxx prior to requiring GSK Xxxxxx to terminate the IRO. However, the final determination as to whether or not to require GSK Xxxxxx to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions ReviewXxxxxx Medical Technology, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). Inc. — Appendix A The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSK’s to Xxxxxx’x systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the second and fourth Reporting Periods. If Xxxxxx materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Xxxxxxxx to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Xxxxxxxx must engage a new IRO within 60 days of termination of the IROprior IRO or at least 60 days prior to the end of the current Reporting Period, whichever is earlier. Prior to requiring GSK Xxxxxxxx to engage a new IRO, OIG shall notify GSK Xxxxxxxx of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Xxxxxxxx may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Xxxxxxxx prior to requiring GSK Xxxxxxxx to terminate the IRO. However, the final determination as to whether or not to require GSK Xxxxxxxx to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSK’s to Xxxxxxxx’x systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Xxxxxxxx materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Forest to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Forest to engage a new IRO, OIG shall notify GSK Forest of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Forest may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Forest shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Forest prior to requiring GSK Forest to terminate the IRO. However, the final determination as to whether or not to require GSK Forest to engage a new IRO shall be made at the sole discretion of OIG. . I. Covered Functions Promotional and Product Related Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Forest shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Forest in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Forest’s Promotional and Product Related Functions and Regulatory Related Functions (collectively, “IRO Covered FunctionsReview”). The IRO Review shall consist of two components - a systems review (“IRO Systems Review) ”), and a transactions review (“IRO Transactions Review”) as described more fully below. GSK Forest may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If The IRO shall perform the IRO Systems Review for the first Reporting Period, and, if there are no material changes in GSKForest’s systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Related Functions or Regulatory Related Functions, the IRO shall perform the IRO Systems Review for the second and fifth IRO fourth Reporting PeriodsPeriod. If GSK Forest materially changes its systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Related Functions or Regulatory Related Functions, the IRO shall perform a an IRO Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional IRO Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the IRO Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph DE or has a prohibited relationship as set forth in paragraph F (as applicable), or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify APM, at Park Center, and Xxxxxx in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. APM, Park Center, and Xxxxxx shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, independence, relationship to APM, Park Center, and Xxxxxx or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by APM, Park Center, and Xxxxxx regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify APM, Park Center, and Xxxxxx in writing that APM, Park Center, and Xxxxxx shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK APM, Park Center, and Xxxxxx must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK APM, Park Center, and Xxxxxx to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌ APPENDIX B ARRANGEMENTS REVIEW‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single Each IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSK’s to APM, Park Center, and Xxxxxx’x systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If APM, Park Center, and Xxxxxx materially change the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify CII in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. CII shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by CII regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify CII in writing that CII shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK CII must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK CII to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - a systems review (Systems Review) Review and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKto CII’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If CII materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Cephalon to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Cephalon to engage a new IRO, OIG shall notify GSK Cephalon of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Cephalon may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Cephalon shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Cephalon prior to requiring GSK Cephalon to terminate the IRO. However, the final determination as to whether or not to require GSK Cephalon to engage a new IRO shall be made at the sole discretion of OIGXXX. I. Covered Functions Promotional and Product Services Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Cephalon shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Cephalon in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Cephalon’s Promotional and Product Services Related Functions (collectively, “IRO Covered Functions”Promotional and Product Services Review). The IRO Promotional and Product Services Review shall consist of two components - a systems review (the “Promotional and Product Services Systems Review) ” or “Systems Review”), and a transactions review (the “Promotional and Product Services Transactions Review” or “Transactions Review”) as described more fully below. GSK Cephalon may engage, at its discretion, a single IRO to perform both components of the IRO Promotional and Product Services Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKCephalon’s systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform the Promotional and Product Services Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Cephalon materially changes its systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform a Promotional and Product Services Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Promotional and Product Services Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in in‌ Paragraph C, OIG mayshall notify Healthquest, at Inc. in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Healthquest, Inc. shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Healthquest, Inc. regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Healthquest, Inc. in writing that Healthquest, Inc. shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Healthquest, Inc. must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Healthquest, Inc. to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌‌ APPENDIX B ARRANGEMENTS REVIEW‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Healthquest, Inc.’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Healthquest, Inc. materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify USWM in writing regarding OIG’s basis for determining‌ that the IRO has not met the requirements of this Appendix. USWM shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by USWM regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify USWM in writing that USWM shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK USWM must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK USWM to engage a new IRO shall be made at the sole discretion of OIG. OIG.‌‌ I. Covered Functions Review, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) USWM shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK USWM in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO the Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK USWM may engage, at its their discretion, a single IRO to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s the applicable systems, processes, policies, and procedures of USWM relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO fourth Reporting Periods. If GSK USWM materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA. II. Systems Review‌

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Allergan to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Allergan to engage a new IRO, OIG shall notify GSK Allergan of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Allergan may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Allergan shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Allergan prior to requiring GSK Allergan to terminate the IRO. However, the final determination as to whether or not to require GSK Allergan to engage a new IRO shall be made at the sole discretion of OIG. XXX. I. Covered Functions Promotional and Product Related Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Allergan shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Allergan in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Allergan’s Promotional and Product Related Functions (collectively, “IRO Covered Functions”Review). The IRO Review shall consist of two components - a systems review (the “Promotional and Product Related Systems Review) ” or “Systems Review”), and a transactions review (the “Promotional and Product Related Transactions Review” or “Transactions Review”) as described more fully below. GSK Allergan may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKAllergan’s systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Related Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Allergan materially changes its systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Related Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) described in Section III.D.1.b of the CIA shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO (including the Legal Reviewer(s)) does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, E or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify TAF in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. TAF shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by TAF regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify TAF in writing that TAF shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK TAF must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK TAF to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions ReviewOIG.‌ Appendix B‌‌ A. IRO Engagement, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) TAF shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) engagements to assist GSK TAF in assessing and evaluating its systems, processes, policies, procedures, and practices procedures related to certain of GSK's Covered Patient Assistance Related Functions as defined in the IA (collectivelyIRO Reviews). Each review shall be performed with respect to the applicable Reporting Period. More specifically, “for the first Reporting Period, the IRO Covered Functions”)Review shall cover calendar year 2020. For the second and third Reporting Periods, the IRO Reviews shall cover calendar years 2021 and 2022, respectively. The IRO Review Reviews shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK TAF may engage, at its discretion, a single IRO entity to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKTAF’s systems, processes, policies, and procedures relating to the Covered IRO Patient Assistance Related Functions, the IRO shall perform the Systems Review outlined below for the second first and fifth IRO third Reporting Periods. If GSK TAF materially changes its systems, processes, policies, and procedures relating to the Covered IRO Patient Assistance Related Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such material changes were made in addition to conducting the Review below for the second first and fifth IRO third Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIAthree Reporting Periods of the IA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Xxxxxxxx to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Xxxxxxxx must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Xxxxxxxx to engage a new IRO, OIG shall notify GSK Xxxxxxxx of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Xxxxxxxx may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Xxxxxxxx prior to requiring GSK Xxxxxxxx to terminate the IRO. However, the final determination as to whether or not to require GSK Xxxxxxxx to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSK’s to Xxxxxxxx’x systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Xxxxxxxx materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, E or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Avanir in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Avanir shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Xxxxxx regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Avanir in writing that Avanir shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Avanir must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Avanir to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX B COVERED FUNCTIONS REVIEW‌‌ I. Covered Functions Review, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) Xxxxxx shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Xxxxxx in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO the Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Avanir may engage, at its discretion, a single IRO to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s the applicable systems, processes, policies, and procedures of Avanir relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Avanir materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA. II. Systems Review‌

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Baxano Surgical to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Baxano Surgical must engage a new IRO within 60 days of termination of the prior IRO. Prior to requiring GSK Baxano Surgical to engage a new IRO, OIG shall notify GSK Baxano Surgical of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Baxano Surgical may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Baxano Surgical prior to requiring GSK Baxano Surgical to terminate the IRO. However, the final determination as to whether or not to require GSK Baxano Surgical to engage a new IRO shall be made at the sole discretion of OIG. OXX. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Baxano Surgical shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Baxano Surgical in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSKBaxano Surgical's Covered Promotional and Product Services Related Functions and Risk Assessment and Monitoring Process (collectively, “IRO Covered Functions”Reviews). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Baxano Surgical may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKBaxano Surgical’s systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Baxano Surgical materially changes its systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Services Related Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK J&J and/or the J&J Pharmaceutical Affiliates to engage a new IRO in accordance with Paragraph A of this Appendix. GSK J&J and/or the J&J Pharmaceutical Affiliates must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK J&J and/or the J&J Pharmaceutical Affiliates to engage a new IRO, OIG shall notify GSK J&J and/or the J&J Pharmaceutical Affiliates of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK J&J and/or the J&J Pharmaceutical Affiliates may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK X&X and/or the J&J Pharmaceutical Affiliates prior to requiring GSK J&J and/or the J&J Pharmaceutical Affiliates to terminate the IRO. However, the final determination as to whether or not to require GSK J&J and/or the J&J Pharmaceutical Affiliates to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) J&J and/or the J&J Pharmaceutical Affiliates shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK the J&J Pharmaceutical Affiliates in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO the Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK J&J and/or the J&J Pharmaceutical Affiliates may engage, at its their discretion, a single IRO to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s the applicable systems, processes, policies, and procedures of the J&J Pharmaceutical Affiliates relating to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO Reporting Periods. If GSK the J&J Pharmaceutical Affiliate materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Hebrew Homes in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Hebrew Homes shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Hebrew Homes regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Hebrew Homes in writing that Hebrew Homes shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Hebrew Homes must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Hebrew Homes to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSK’s to Hebrew Homes’ systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Hebrew Homes materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify SDNA in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. SDNA shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by SDNA regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify SDNA in writing that SDNA shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK SDNA must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK SDNA to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto SDNA’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If SDNA materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Provider in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Provider shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Provider regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Provider in writing that Provider shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Provider must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the final The final‌ determination as to whether or not to require GSK Provider to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌‌ APPENDIX B ARRANGEMENTS REVIEW‌ The IRO Arrangements Review shall consist of two components - a systems review (Systems Review) Review and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKto Provider’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Provider materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Xxxxxx to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Xxxxxx must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Xxxxxx to engage a new IRO, OIG shall notify GSK Balboa of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Xxxxxx may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Balboa prior to requiring GSK Balboa to terminate the IRO. However, the final determination as to whether or not to require GSK Xxxxxx to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Xxxxxx’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Balboa materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Post Acute Medical in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Post Acute Medical shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Post Acute Medical regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Post Acute Medical in writing that Post Acute Medical shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Post Acute Medical must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Post Acute Medical to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Post Acute Medical’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Post Acute Medical materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Family Dermatology to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Family Dermatology must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Family Dermatology to engage a new IRO, OIG shall notify GSK Family Dermatology of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Family Dermatology may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Family Dermatology prior to requiring GSK Family Dermatology to terminate the IRO. However, the final determination as to whether or not to require GSK Family Dermatology to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Family Dermatology’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Family Dermatology materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify GSMC in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. GSMC shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by GSMC regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify GSMC in writing that GSMC shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK GSMC must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK GSMC to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌‌‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto GSMC’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If GSMC materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE (as applicable), or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Northwell in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Northwell shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship to Northwell or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Xxxxxxxxx regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Northwell in writing that Northwell shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Xxxxxxxxx must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Xxxxxxxxx to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Northwell’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Northwell materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Novartis to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Novartis must engage a new IRO within 60 days of termination of the IROprior IRO or at least 60 days prior to the end of the current Reporting Period, whichever is earlier. Prior to requiring GSK Novartis to engage a new IRO, OIG shall notify GSK Novartis of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Novartis may present additional information regarding the IRO’s qualifications, independence independence, or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Novartis prior to requiring GSK Novartis to terminate the IRO. However, the final determination as to whether or not to require GSK Novartis to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Promotional and Product Related Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Novartis shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Novartis in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Novartis’ Promotional Functions and Product Related Functions (collectively, “IRO Covered Functions”Review). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Novartis may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s Novartis’ systems, processes, policies, and procedures relating to the Covered IRO applicable Promotional Functions and/or Product Related Functions, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Novartis materially changes its systems, processes, policies, and procedures relating to the Covered IRO applicable Promotional Functions and/or Product Related Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: : 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify WBH in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. WBH shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by WBH regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify WBH in writing that WBH shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK WBH must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK WBH to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto WBH’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If WBH materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify FHS in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. FHS shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by FHS regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify FHS in writing that FHS shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK FHS must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK FHS to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions APPENDIX B MINIMUM DATA SET REVIEW‌ A. Minimum Data Set Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Minimum Data Set (MDS) Review for annually to cover each of the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO five Reporting Periods. The additional Systems Review(sMDS Review shall be conducted at five FHS Entity facilities selected by OIG (each a “Subject Facility” and‌‌ collectively referred to as the “Subject Facilities”) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changedfor each Reporting Period. The IRO shall conduct the Transactions Review for perform all components of each IRO Reporting Period of the CIAMDS Review.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Rockport in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Rockport shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Rockport regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Rockport in writing that Rockport shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Rockport must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Rockport to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - a systems review (Systems Review) Review and a transactions review (Transactions Review) as described more fully below. GSK may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKto Rockport ’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Rockport materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK PHC to engage a new IRO in accordance with Paragraph A of this Appendix. GSK PHC must engage a new IRO within 60 days of termination of the prior IRO. Prior to requiring GSK PHC to engage a new IRO, OIG shall notify GSK PHC of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK PHC may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK PHC prior to requiring GSK PHC to terminate the IRO. However, the final determination as to whether or not to require GSK PHC to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto PHC’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If PHC materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Memorial Health in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Memorial Health shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Memorial Health regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Memorial Health in writing that Memorial Health shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Memorial Health must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Memorial Health to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Memorial Health’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Memorial Health materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Forest to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Forest to engage a new IRO, OIG shall notify GSK Forest of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Xxxxxx may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Forest shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Forest prior to requiring GSK Forest to terminate the IRO. However, the final determination as to whether or not to require GSK Forest to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Promotional and Product Related Review, General Description As specified more fully below, GlaxoSmithKline (GSK) Forest shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Forest in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSKForest's Covered Promotional and Product Related Functions and Regulatory Related Functions (collectively, “IRO Covered FunctionsReview”). The IRO Review shall consist of two components - a systems review (“IRO Systems Review) ”), and a transactions review (“IRO Transactions Review”) as described more fully below. GSK Forest may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If The IRO shall perform the IRO Systems Review for the first Reporting Period, and, if there are no material changes in GSK’s Forest's systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Related Functions or Regulatory Related Functions, the IRO shall perform the IRO Systems Review for the second and fifth IRO fourth Reporting PeriodsPeriod. If GSK Forest materially changes its systems, processes, policies, and procedures relating to the Covered IRO Promotional and Product Related Functions or Regulatory Related Functions, the IRO shall perform a an IRO Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional IRO Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the IRO Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Home Bound in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Home Bound shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Home Bound regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Home Bound in writing that Home Bound shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Home Bound must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Home Bound to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Home Bound’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Home Bound materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify WCH in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. WCH shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by WCH regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify WCH in writing that WCH shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK WCH must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK WCH to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌ APPENDIX B ARRANGEMENTS REVIEW‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto WCH’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If WCH materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify SOS in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. SOS shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by SOS regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify SOS in writing that SOS shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK SOS must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK SOS to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto SOS’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If SOS materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Biovail to engage a new IRO in accordance with Paragraph A of this Appendix. GSK must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Biovail to engage a new IRO, OIG shall notify GSK Biovail of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Biovail may present additional information regarding request a meeting with OIG to discuss any aspect of the IRO’s qualifications, independence or performance of its responsibilitiesresponsibilities and to present additional information regarding these matters. Biovail shall provide any additional information as may be requested by OIG under this Paragraph in an expedited manner. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Biovail prior to requiring GSK Biovail to terminate the IRO. However, the final determination as to whether or not to require GSK Biovail to engage a new IRO shall be made at the sole discretion of OIG. XXX. I. Covered Functions Review, IRO System and Transaction Reviews — General Description As specified more fully below, GlaxoSmithKline (GSK) Biovail shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Biovail in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Government Pricing and Contracting Functions (collectivelyas defined in Section II.C.3 of the CIA) and to Promotional and Product Services Related Functions (as defined in Section II.C.5 of the CIA). To the extent that the CIA requires a review of transactions or activities, “the IRO Covered Functions”)shall review transactions and activities that occur subsequent to the Effective Date of the CIA. The IRO Review shall consist perform two types of two components - a systems review (engagements. First, the IRO shall perform two-part system reviews of: 1) Biovail’s systems, processes, policies, and procedures relating to the calculation and reporting of AMP, BP, and ASP for purposes of the Medicaid Drug Rebate program and the Medicare program, respectively; and 2) Biovail’s systems, processes, policies, and procedures relating to certain elements of its Promotional and Product Services Related Functions. Collectively, these reviews shall be known as the “Systems Review) and a transactions review (”. Second, the IRO shall perform Transactions Review) Reviews as described more fully belowbelow in Section III. GSK Biovail may engage, at its discretion, a single IRO to perform both components of the IRO Review Systems Reviews and the Transactions Reviews provided that the entity has the necessary expertise and capabilities to perform both. If If, during the term of the CIA, there are no material changes in GSKBiovail’s Government Pricing and Contracting related systems, processes, policies, and procedures relating related to AMP, BP, or ASP or in Biovail’s Promotional and Product Services Related Functions related to the Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functionsitems identified in Section II.B below, the IRO shall perform a Systems Review for the first and fourth Reporting Periods, If, during the term of the CIA, Biovail materially changes its Government Pricing and Contracting related systems, processes, policies, and procedures related to AMP, BP, or ASP, or its Promotional and Product Services Related Functions as they relate to the items set forth in Section II.B, the IRO shall perform a Systems Review for the Reporting Period(s) Period in which such changes were made in addition to conducting the Systems Review for the second first and fifth IRO fourth Reporting Periods. The Any additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other the systems, processes, policies, and procedures previously already reported on did not materially change; and 3) a review of an update on the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA. II. Systems Review A. Systems Review - Part 1 (relating to AMP, BP, and ASP) a) The systems, processes, policies, and procedures used to determine which Biovail customers are included or excluded for purposes of calculating AMP, BP, and ASP; b) The systems, policies, processes, and procedures used to determine whether and which particular transactions (e.g., discounts, rebates) are included in or excluded from AMP, BP, and ASP determinations; c) A review of Biovail’s methodology for applying transactions to the AMP, BP, and ASP determinations; d) A review of Biovail’s methodology for estimating any prices, discounts, or other amounts used in determining AMP, BP, and ASP; e) The flow of data and information by which price, contract terms, and transactions with Biovail customers are accumulated from the source systems and entered and tracked in Biovail’s information systems for purposes of determining AMP, BP, and ASP; f) A review of any Biovail inquiries to CMS regarding AMP, BP, and ASP determinations and reporting requirements, including requests for interpretation or guidance, and any responses to those inquiries; and g) The controls and processes in place to examine and address system reports that require critical evaluation (such as reports of variations, exceptions, or outliers). This shall include a review of the bases upon which variations, exceptions, and outliers are identified and the follow-up actions undertaken to identify the cause of any variations. B. Systems Review - Part 2 (

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph DE or has a prohibited relationship as set forth in paragraph F (as applicable), or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Radeas in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Radeas shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence, relationship to Radeas or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Radeas regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Radeas in writing that Radeas shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Radeas must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Radeas to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Radeas’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Radeas materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, E or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Taro in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Taro shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns‌ identified by OIG. If, require GSK following OIG’s review of any information provided by Xxxx regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Taro in writing that Taro shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Taro must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Taro to engage a new IRO shall be made at the sole discretion of OIG. APPENDIX B‌‌ I. Covered Pricing and Contracting Functions Review, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) Xxxx shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Xxxx in assessing and evaluating its certain systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”)practices. The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Taro may engage, at its discretion, a single IRO to perform both components of the IRO Review Reviews provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSK’s the applicable systems, processes, policies, and procedures of Taro relating to the Covered IRO Functionsreviewed Policies and Procedures described below, the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK Taro materially changes its applicable systems, processes, policies, and procedures relating to the Covered IRO Functionsprocedures, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Systems Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA. II. Systems Review‌

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify the GIS Parties in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. The GIS Parties shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by the GIS Parties regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify the GIS Parties in writing that the GIS Parties shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK The GIS Parties must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK the GIS Parties to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). OIG.‌ APPENDIX B ARRANGEMENTS REVIEW‌‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSK’s to the GIS Parties’ systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If the GIS Parties materially change the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective has a prohibited relationship as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Flower Mound in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Flower Mound shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at relationship or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Flower Mound regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Flower Mound in writing that Flower Mound shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Flower Mound must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Flower Mound to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSK's Covered Functions (collectively, “IRO Covered Functions”). APPENDIX B ARRANGEMENTS REVIEW‌‌‌‌ The IRO Arrangements Review shall consist of two components - components: a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully belowreview. GSK may engage, at its discretion, a single The IRO to shall perform both all components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform botheach Arrangements Review. If there are no material changes in GSKto Flower Mound’s systems, processes, policies, and procedures relating to Arrangements, the Covered IRO FunctionsArrangements Systems Review shall be performed for the first and fourth Reporting Periods. If Flower Mound materially changes the Arrangements systems, processes, policies and procedures, the IRO shall perform the an Arrangements Systems Review for the second and fifth IRO Reporting Periods. If GSK materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) Period in which such changes were made in addition to conducting the Review systems review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) Arrangements Transactions Review shall consist of: 1) an identification be performed annually and shall cover each of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO five Reporting Period of the CIAPeriods.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK Amgen to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Amgen must engage a new IRO within 60 days of termination of the IRO. Prior to requiring GSK Amgen to engage a new IRO, OIG shall notify GSK Amgen of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK Amgen may present additional information regarding the IRO’s qualifications, independence independence, or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK Amgen prior to requiring GSK Amgen to terminate the IRO. However, the final determination as to whether or not to require GSK Amgen to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline Amgen Inc. (GSKAmgen) shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK Amgen in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSKAmgen's Covered Functions (collectively, “IRO Covered Functions”). The IRO Review Reviews shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Amgen may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKAmgen’s systems, processes, policies, and procedures relating to the relevant Covered IRO Functions, the IRO shall perform the Systems Review for the second and fifth IRO fourth Reporting Periods. If GSK Amgen materially changes its systems, processes, policies, and procedures relating to the relevant Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) a review of the systems, processes, policies, and procedures that materially changed; and 3) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or objective as set forth in Paragraph D, or has failed to carry out its responsibilities as described in Paragraph C, OIG may, at its sole discretion, require GSK BIPI to engage a new IRO in accordance with Paragraph A of this Appendix. GSK BIPI must engage a new IRO within 60 days of termination of the prior IRO. Prior to requiring GSK BIPI to engage a new IRO, OIG shall notify GSK BIPI of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK BIPI may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK BIPI prior to requiring GSK BIPI to terminate the IRO. However, the final determination as to whether or not to require GSK BIPI to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions Promotional and Product Services Review, General Description As specified more fully below, GlaxoSmithKline (GSK) BIPI shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) to assist GSK BIPI in assessing and evaluating its systems, processes, policies, procedures, and practices related to certain of GSKBIPI's Covered Promotional Functions and Product Related Functions (collectively, “IRO Covered Functions”Review). The IRO Review shall consist of two components - a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK BIPI may engage, at its discretion, a single IRO to perform both components of the IRO Review provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKBIPI’s systems, processes, policies, and procedures relating to the Promotional Functions and Product Related Functions (collectively “Covered IRO Functions”), the IRO shall perform the Systems Review for the second first and fifth IRO fourth Reporting Periods. If GSK BIPI materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second first and fifth IRO fourth Reporting Periods. The additional Systems Review(s) shall consist of: 1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.

OIG Removal of IRO. In the event OIG has reason to believe that the IRO does not possess the qualifications described in Paragraph B, is not independent and/or and objective as set forth in Paragraph D, E or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Essilor in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Essilor shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence or performance of its sole discretionresponsibilities in order to resolve the concerns identified by OIG. If, require GSK following OIG’s review of any information provided by Xxxxxxx regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Essilor in writing that Essilor shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Essilor must engage a new IRO within 60 days of termination its receipt of the IROOIG’s written notice. Prior to requiring GSK to engage a new IRO, OIG shall notify GSK of its intent to do so and provide a written explanation of why OIG believes such a step is necessary. To resolve any concerns raised by OIG, GSK may present additional information regarding the IRO’s qualifications, independence or performance of its responsibilities. OIG will attempt in good faith to resolve any differences regarding the IRO with GSK prior to requiring GSK to terminate the IRO. However, the The final determination as to whether or not to require GSK Essilor to engage a new IRO shall be made at the sole discretion of OIG. I. Covered Functions ReviewAPPENDIX B‌‌ A. IRO Engagement, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) Essilor shall retain an Independent Review Organization (IRO) (or IROs) IRO to perform reviews (IRO Reviews) engagements to assist GSK Xxxxxxx in assessing and evaluating certain of its systems, processes, policies, procedures, and practices procedures related to certain of GSK's Essilor’s Covered Functions (collectively, “as defined in Section II.C.3 of the CIA) (IRO Covered Functions”Review). The IRO Review shall consist of two components - three components—a systems review (Systems Review) and ), a transactions review (Transactions Review) ), and an Additional Items Review as described more fully below. GSK Essilor may engage, at its discretion, a single IRO entity to perform both components of the IRO Review Reviews, provided that the entity has the necessary expertise and capabilities to perform both. If there are no material changes in GSKEssilor’s systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform the Systems Review of certain systems, processes, policies and procedures relating to Covered Functions (as set forth below) for the second first and fifth IRO fourth Reporting Periods. If GSK Essilor materially changes its systems, processes, policies, and procedures relating to the Covered IRO Functions, the IRO shall perform a Systems Review for the IRO Reporting Period(s) in which such changes were made in addition to conducting the Review for the second and fifth IRO Reporting Periodsas set forth above. The additional Systems Review(s) shall consist of: (1) an identification of the material changes; 2) an assessment of whether other systems, processes, policies, and procedures previously reported did not materially change; and 3(2) a review of the systems, processes, policies, and procedures that materially changed. The IRO shall conduct the Transactions Review for each IRO Reporting Period of the CIA.