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 shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were Provider 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) Provider had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) Provider has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) Provider 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) Provider 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)Provider, only after a DAB decision in favor of OIG. J&JThe Provider’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) Provider 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) Provider 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 Provider 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)Provider, the J&J Pharmaceutical Affiliate(s) Provider 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 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 Xxxxx’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 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 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 Corporate Integrity Agreement King Pharmaceuticals, Inc. Xxxxxx Xxxxxx 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 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 IA shall be: a. whether J&J and/or the J&J Pharmaceutical Affiliate(s) were Ho Medical 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) Ho Medical had begun to take action to cure the material breach within that period; (ii) J&J and/or the J&J Pharmaceutical Affiliate(s) Ho Medical has pursued and is pursuing such action with due diligence; and (iii) J&J and/or the J&J Pharmaceutical Affiliate(s) Ho Medical 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) Ho Medical 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)Ho Medical, only after a DAB decision in favor of OIG. J&JHo Medical’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) Ho Medical 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) Ho Medical 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) Ho Medical shall waive its [his, her or 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)Ho Medical, the J&J Pharmaceutical Affiliate(s) Ho Medical 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) Xxxx 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 XXX 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)Xxxx, the J&J Pharmaceutical Affiliate(s) EPI shall be reinstated effective on the date of the original exclusion.