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. Appendix B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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. Progenity, Inc. CIA Appendix A APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix B to CIA for GlaxoSmithKline LLC Xxxxxxx & Xxxxxxx Independent Review Organization Reviews 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix B to CIA for GlaxoSmithKline LLC Independent Promotional and Product Related Review Organization Reviews 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, 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 Corporate Integrity Agreement Biotronik, Inc. 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. Appendix Corporate Integrity Agreement Biotronik, Inc. APPENDIX B INDEPENDENT REVIEW ORGANIZATION REVIEWS The IRO shall perform a Systems Review and a Transactions Review relating to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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 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, 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. Appendix OIG.‌‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix OIG.‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix B Xxxxxxxx X to CIA for GlaxoSmithKline LLC Independent Cephalon, Inc. Promotional and Product Services Review Organization Reviews 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix OIG.‌‌‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix OIG.‌‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 Appendix B to CIA for GlaxoSmithKline LLC Independent Promotional and Product Services Review Organization Reviews 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 APPENDIX B to TO CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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 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. Appendix B to CIA for GlaxoSmithKline LLC Amgen Inc. Independent Review Organization Reviews 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 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. Appendix OIG.‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix OIG.‌‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix OIG.‌‌‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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, 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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, 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. Exactech, Inc. - Appendix A APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix OIG.‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 cannot meet the requirement to conduct both the Rehab Review and the Therapy Systems Assessment as required by this Appendix A, 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 LCCA in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. LCCA 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 LCCA regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify LCCA in writing that LCCA shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK LCCA 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 LCCA to engage a new IRO shall be made at the sole discretion of OIGOIG.‌ APPENDIX B REHABILITATION THERAPY SERVICES REVIEW‌‌ A. Rehabilitation Therapy Services Review. Appendix B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews I. Covered Functions Review, General Description As specified more fully below, GlaxoSmithKline (GSK) LCCA 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 a Rehabilitation Therapy Services Review (Rehab Review) annually for each 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 five Reporting Periods. The additional Systems Review(sRehab Review shall be conducted at five LCCA facilities (“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 CIA.Rehab 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 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. Appendix B to CIA for GlaxoSmithKline LLC Amgen Inc. Independent Review Organization Reviews 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 GSKXxxxx'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, 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. Xxxxxx Medical Technology, Inc. — Appendix A Appendix B to CIA for GlaxoSmithKline LLC Independent Arrangements Review Organization Reviews 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 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix OIG.‌‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix OIG.‌‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix OIG.‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix B to CIA for GlaxoSmithKline LLC Independent Promotional and Product Related Review Organization Reviews 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix B to CIA for GlaxoSmithKline LLC Independent Promotional and Product Services Review Organization Reviews 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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, E or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Arthrex in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Arthrex 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 Arthrex regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Arthrex in writing that Arthrex shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Arthrex 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 Arthrex to engage a new IRO shall be made at the sole discretion of OIG. Appendix B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews I. Covered Functions ReviewOIG.‌ APPENDIX B‌ INDEPENDENT REVIEW ORGANIZATION REVIEWS A. IRO Engagement, General Description Description‌ As specified more fully below, GlaxoSmithKline (GSK) Arthrex shall retain an Independent Review Organization (IRO) (or IROs) IRO to perform reviews (IRO Reviews) engagements to assist GSK Arthrex in assessing and evaluating certain of its systems, processes, policies, procedures, and practices procedures related to certain of GSK's Arthrex’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 - components—a systems review (Systems Review) and a transactions review (Transactions Review) as described more fully below. GSK Arthrex 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 GSKArthrex’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 Arthrex 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.

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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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 Vascular Access Centers in writing regarding OIG’s basis for determining that the IRO has not met the requirements of this Appendix. Vascular Access Centers shall have 30 days from the date of OIG’s written notice to provide information regarding the IRO’s qualifications, at independence, relationship to Vascular Access Centers 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 Vascular‌ Access Centers regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Vascular Access Centers in writing that Vascular Access Centers shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Vascular Access Centers 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 Vascular Access Centers to engage a new IRO shall be made at the sole discretion of OIG. Appendix OIG.‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 Vascular Access Centers’ 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 Vascular Access Centers 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. Appendix B to CIA for GlaxoSmithKline LLC Independent Promotional and Product Related Review Organization Reviews 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 (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 Northwell 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 Northwell 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 Northwell to engage a new IRO shall be made at the sole discretion of OIG. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix OIG.‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 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. Appendix B Spectranetics Corporate Integrity Agreement Xxxxxxxx X to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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, 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. Appendix APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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 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 and objective as set forth in Paragraph DE, or has failed to carry out its responsibilities as described in Paragraph C, OIG mayshall notify Jazz in writing regarding OIG’s basis for determining that‌ the IRO has not met the requirements of this Appendix. Jazz 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 Jazz regarding the IRO, OIG determines that the IRO has not met the requirements of this Appendix, OIG shall notify Jazz in writing that Jazz shall be required to engage a new IRO in accordance with Paragraph A of this Appendix. GSK Jazz 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 Jazz to engage a new IRO shall be made at the sole discretion of OIG. OIG.‌‌ CIA with Jazz Pharmaceuticals PLC Appendix B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews B‌ I. Covered Functions ReviewIRO Engagement, General Description As specified more fully below, GlaxoSmithKline (GSK) Jazz shall retain an Independent Review Organization (IRO) (or IROs) to perform reviews (IRO Reviews) engagements to assist GSK Jazz in assessing and evaluating its systems, processes, policies, procedures, and practices procedures related to certain of GSK's Covered Functions as defined in the CIA (collectively, “IRO Covered Functions”Reviews). 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 Jazz 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 GSKJazz’s systems, processes, policies, and procedures relating to the Covered IRO Contribution and Assistance Related Functions, the IRO shall perform the Systems Review for the second and fifth IRO fourth Reporting Periods. If GSK Jazz materially changes its systems, processes, policies, and procedures relating to the Covered IRO Contribution and Assistance 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 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) 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 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. Appendix OIG.‌ APPENDIX B to CIA for GlaxoSmithKline LLC Independent Review Organization Reviews 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”). 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.