Common use of Exclusion Review Clause in Contracts

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s), only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s), the J&J Pharmaceutical Affiliate(s) shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA IA shall be: a. be whether J&J and/or the J&J Pharmaceutical Affiliate(s) were ▇▇▇▇▇▇ was in material breach of this CIA;IA and, if so, whether: ▇. ▇▇▇▇▇▇ cured such breach within 30 days of its receipt of the Notice of Material Breach; or b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: , during the 30 day period following ▇▇▇▇▇▇’▇ receipt of the Notice of Material Breach: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ had begun to take action to cure the material breach within that periodbreach; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has ▇▇▇▇▇▇ pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has followed the timetablebreach. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ ▇▇▇▇▇▇’▇ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) Norman upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, D.O., ▇▇▇▇▇ ▇▇▇▇▇▇, Dermatology Healthcare, LLC, and ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, D.O., P.A. shall waive its their right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇, the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA IA shall be: a. be whether J&J and/or the J&J Pharmaceutical Affiliate(s) were ▇▇▇▇▇ was in material breach of this CIA;IA and, if so: a. Anand cured such breach within 30 days of its receipt of the Notice of Material Breach; or b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: , during the 30-day period following ▇▇▇▇▇’s receipt of the Notice of Material Breach: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇ had begun to take action to cure the material breach within that periodbreach; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has ▇▇▇▇▇ pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇ provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has followed the timetablebreach. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s), ▇▇▇▇▇ only after a DAB decision in favor of OIG. J&J▇▇▇▇▇’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its his contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇ upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇ may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇ shall waive its his right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇, the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇ shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇ and EHS were in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) EPI had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) EPI has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) EPI provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) Endo has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)Endo, only after a DAB decision in favor of OIG. J&JEPI’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) EPI upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) EPI may request review of the ALJ decision by the DAB. If the DAB Endo Pharmaceuticals Inc. Corporate Integrity Agreement ▇▇▇ finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) EPI shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇, the J&J Pharmaceutical Affiliate(s) EPI shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. be whether J&J and/or the J&J Pharmaceutical Affiliate(s) were ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ was in material breach of this CIA;CIA and, if so, whether: ▇. ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ cured such breach within 30 days of its receipt of the Notice of Material Breach; or b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that, during the 30 day period following ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇’▇ receipt of the Notice of Material Breach: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ had begun to take action to cure the material breach within that periodbreach; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has followed the timetablebreach. ▇▇▇▇▇▇▇▇▇▇–Zwanger ▇▇▇▇▇▇ – Corporate Integrity Agreement For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇’▇ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇▇▇▇▇- ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇ shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA IA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were ▇▇▇▇▇-JCA was in material breach of this CIAIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA had begun to take action to cure the material breach within that period; (ii▇▇) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇-JCA, only after a DAB decision in favor of OIG. J&J▇▇▇▇▇-JCA’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇-JCA, the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇-JCA shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA IA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were ▇▇▇▇▇▇▇ was in material breach of this CIAIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇▇, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ ▇▇▇▇▇▇▇’▇ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ shall waive its his right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇▇, the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇ shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were Zimmer was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) had Zimmer has begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) Zimmer has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) Zimmer provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) Zimmer has followed the timetable. Corporate Integrity Agreement between OIG-HHS and Z▇▇▇▇▇, Inc. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)Zimmer, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ Z▇▇▇▇▇’▇ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) Zimmer upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) Zimmer may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) Zimmer shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)Zimmer, the J&J Pharmaceutical Affiliate(s) Zimmer shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. be whether J&J and/or the J&J Pharmaceutical Affiliate(s) APM, Park Center, and ▇▇▇▇▇▇ were in material breach of this CIA;CIA and, if so, whether:‌ a. APM, Park Center, and ▇▇▇▇▇▇ cured such breach within 30 days of its receipt of the Notice of Material Breach; or b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that, during the 30 day period following APM, Park Center, and ▇▇▇▇▇▇’▇ receipt of the Notice of Material Breach: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) APM, Park Center, and ▇▇▇▇▇▇ had begun to take action to cure the material breach within that periodbreach; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has APM, Park Center, and ▇▇▇▇▇▇ pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) APM, Park Center, and ▇▇▇▇▇▇ provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has followed the timetablebreach. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)APM, Park Center, and ▇▇▇▇▇▇, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ APM, Park Center, and ▇▇▇▇▇▇’▇ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) APM, Park Center, and ▇▇▇▇▇▇ upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) APM, Park Center, and ▇▇▇▇▇▇ may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) APM, Park Center, and ▇▇▇▇▇▇ shall waive its right their rights to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)APM, the J&J Pharmaceutical Affiliate(s) Park Center, and ▇▇▇▇▇▇, APM, Park Center, and ▇▇▇▇▇▇ shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. be whether J&J and/or the J&J Pharmaceutical Affiliate(s) were Prime was in material breach of this CIA;CIA and, if so, whether:‌ a. Prime cured such breach within 30 days of its receipt of the Notice of Material Breach; or‌ b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: , during the 30 day period following ▇▇▇▇▇’s receipt of the Notice of Material Breach:‌ (i) J&J and/or the J&J Pharmaceutical Affiliate(s) Prime had begun to take action to cure the material breach within that period; breach;‌ (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has Prime pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) Prime provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has followed the timetable. breach.‌ For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)Prime, only after a DAB decision in favor of OIG. J&JPrime’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) Prime upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) Prime may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) Prime shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)Prime, the J&J Pharmaceutical Affiliate(s) Prime shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA IA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) Providers were in material breach of this CIAIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) Providers had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has Providers have pursued and is are pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) Providers provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has Providers have followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)Providers, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)The Providers’ election of its their contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) Providers upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) Providers may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) The Providers shall waive its their right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)Providers, the J&J Pharmaceutical Affiliate(s) Providers shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were HealthSouth was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; andand Corporate Integrity Agreement HealthSouth Corporation c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) HealthSouth had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) HealthSouth has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) HealthSouth provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) HealthSouth has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)HealthSouth, only after a DAB decision in favor of OIG. J&JHealthSouth’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) HealthSouth upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) HealthSouth may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) HealthSouth shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)HealthSouth, the J&J Pharmaceutical Affiliate(s) HealthSouth shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title Chapter 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were Rotech was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-30 day period, but that: : (i) J&J and/or the J&J Pharmaceutical Affiliate(s) Rotech had begun to take action to cure the material breach within that period; ; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) Rotech has pursued and is pursuing such action with due diligence; and and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) Rotech provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) Rotech has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)Rotech, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ Rotech's election of its contractual right to appeal to the DAB shall not abrogate the OIG’s 's authority to exclude the J&J Pharmaceutical Affiliate(s) Rotech upon the issuance of an ALJ’s 's decision in favor of the OIG. If the ALJ sustains the determination of the OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) Rotech may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) shall Rotech agrees to waive its its/his/her right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s), the J&J Pharmaceutical Affiliate(s) shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were ▇▇▇▇▇▇ was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ has followed the timetable. ▇▇▇▇▇▇ Medical Technology, Inc. — Corporate Integrity Agreement For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ ▇▇▇▇▇▇’▇ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇, the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇ shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were Novartis was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) Novartis had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) Novartis has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) Novartis provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) Novartis has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)Novartis, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)Novartis’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) Novartis upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) Novartis may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) Novartis shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)Novartis, the J&J Pharmaceutical Affiliate(s) Novartis shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Corporate Integrity Agreement King Pharmaceuticals, Inc. ▇▇▇▇▇▇ ▇▇▇▇▇▇ Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were King was in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) King had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) King has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) King provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) King has followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)King, only after a DAB decision in favor of OIG. J&JKing’s and/or a J&J Pharmaceutical Affiliate(s)’ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) King upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) King may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) King shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)King, the J&J Pharmaceutical Affiliate(s) King shall be reinstated effective on the date of the original exclusion.

Exclusion Review. Notwithstanding any provision of Title 42 of the United States Code or Title 42 of the Code of Federal Regulations, the only issues in a proceeding for exclusion based on a material breach of this CIA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇-▇▇▇▇▇▇ were in material breach of this CIA; b. whether such breach was continuing on the date of the Exclusion Letter; and c. whether the alleged material breach could not have been cured within the 30-day period, but that: (i) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇-▇▇▇▇▇▇ had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) has Harmony-▇▇▇▇▇▇ have pursued and is are pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇- ▇▇▇▇▇▇ provided to OIG within that period a reasonable timetable for curing the material breach and J&J and/or the J&J Pharmaceutical Affiliate(s) has ▇▇▇▇▇▇▇-▇▇▇▇▇▇ have followed the timetable. For purposes of the exclusion herein, exclusion shall take effect only after an ALJ decision favorable to OIG, or, if the ALJ rules for J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇▇-▇▇▇▇▇▇, only after a DAB decision in favor of OIG. J&J’s and/or a J&J Pharmaceutical Affiliate(s)’ ▇▇▇▇▇▇▇-▇▇▇▇▇▇’▇ election of its contractual right to appeal to the DAB shall not abrogate OIG’s authority to exclude the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇-▇▇▇▇▇▇ upon the issuance of an ALJ’s decision in favor of OIG. If the ALJ sustains the determination of OIG and determines that exclusion is authorized, such exclusion shall take effect 20 days after the ALJ issues such a decision, notwithstanding that J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇-▇▇▇▇▇▇ may request review of the ALJ decision by the DAB. If the DAB finds in favor of OIG after an ALJ decision adverse to OIG, the exclusion shall take effect 20 days after the DAB decision. J&J and/or the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇-▇▇▇▇▇▇ shall waive its right to any notice of such an exclusion if a decision upholding the exclusion is rendered by the ALJ or DAB. If the DAB finds in favor of J&J and/or the J&J Pharmaceutical Affiliate(s)▇▇▇▇▇▇▇-▇▇▇▇▇▇, the J&J Pharmaceutical Affiliate(s) ▇▇▇▇▇▇▇-▇▇▇▇▇▇ shall be reinstated effective on the date of the original exclusion.