Other Regulatory Protection. Except for oxygen products, none of the Loan Parties and their Subsidiaries manufactures pharmaceutical products. Except as set forth on Schedule 6.1.18, none of the Loan Parties and none of the Subsidiaries of the Loan Parties (a) participates in Medicare or Medicaid as a provider or supplier, rather, the Loan Parties and their Subsidiaries are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program, (b) is a party to any Medicare Provider Agreement or Medicaid Provider Agreement, or (c) bills for items or services to any Medical Reimbursement Program. Each of the Loan Parties and its Subsidiaries is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration ("FDA"), the Federal Trade Commission ("FTC"), the Occupational Safety and Health Administration ("OSHA"), the Consumer Product Safety Commission, the United States Customs Service and the United States Postal Service and other state or federal regulatory authorities or jurisdictions in which such Loan Party or any of its Subsidiaries do business or distribute and market products, except to the extent that any such noncompliance, individually or in the aggregate, does not constitute a Material Adverse Change. Neither the FDA, the FTC, OSHA, the Consumer Product Safety Commission, nor any other such regulatory authority has requested (or, to the knowledge of any Authorized Officer, are considering requesting) any product recalls or other enforcement actions that (a) if complied with, individually or in the aggregate, could constitute a Material Adverse Change or (b) with which the Loan Parties and their Subsidiaries have not complied within the time period allowed.
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Other Regulatory Protection. Except for oxygen products, none of the Loan Parties and their Subsidiaries manufactures pharmaceutical products. Except as set forth on Schedule 6.1.18, none of the Loan Parties and none of the Subsidiaries of the Loan Parties (a) participates in Medicare or Medicaid as a provider or supplier, rather, the Loan Parties and their Subsidiaries are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program, (b) is a party to any Medicare Provider Agreement or Medicaid Provider Agreement, or (c) bills for items or services to any Medical Reimbursement Program. Each of the Loan Parties and its Subsidiaries is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration ("“FDA"”), the Federal Trade Commission ("“FTC"”), the Occupational Safety and Health Administration ("“OSHA"”), the Consumer Product Safety Commission, the United States Customs Service and the United States Postal Service and other state or federal regulatory authorities or jurisdictions in which such Loan Party or any of its Subsidiaries do business or distribute and market products, except to the extent that any such noncompliance, individually or in the aggregate, does not constitute a Material Adverse Change. Neither the FDA, the FTC, OSHA, the Consumer Product Safety Commission, nor any other such regulatory authority has requested (or, to the knowledge of any Authorized Officer, are considering requesting) any product recalls or other enforcement actions that (a) if complied with, individually or in the aggregate, could constitute a Material Adverse Change or (b) with which the Loan Parties and their Subsidiaries have not complied within the time period allowed.
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