Common use of Other Regulatory Protection Clause in Contracts

Other Regulatory Protection. Except for oxygen products, none of Loan Parties nor any Subsidiary of any Borrower manufactures pharmaceutical products. Except as set forth on Schedule 5.28, none of Loan Parties and none of the Subsidiaries of Borrowers (a) participates in Medicare or Medicaid or other similar government programs in applicable jurisdictions as a provider or supplier, rather, Loan Parties and the Subsidiaries of Borrowers are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program or other similar government programs in applicable jurisdictions, (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 or other similar government programs in applicable jurisdictions. Each of Loan Parties and the Subsidiaries of Borrowers is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration and Health Canada (for purposes hereof collectively, “FDA”), the Federal Trade Commission (for purposes hereof, “FTC”), the Consumer Product Safety Commission, the United States Customs Service and the United States Postal Service and other state, national, provincial or federal regulatory authorities or jurisdictions in which such Loan Party or any of Borrowers’ 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 Effect. Neither the FDA , the FTC, 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, would reasonably be expected to constitute a Material Adverse Effect or (b) with which Loan Parties and Subsidiaries of Borrowers have not complied within the time period allowed, except where any such failure would not reasonably be expected to have a Material Adverse Effect.

Other Regulatory Protection. Except for oxygen products, none of Loan Parties nor any Subsidiary of any Borrower and their Subsidiaries manufactures pharmaceutical products. Except as set forth on Schedule 5.285.31, none of Loan Parties and none of the Subsidiaries of Borrowers Loan Parties (a) participates in Medicare or Medicaid or other similar government programs in applicable jurisdictions as a provider or supplier, rather, Loan Parties and the their Subsidiaries of Borrowers are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program or other similar government programs in applicable jurisdictions, (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 or other similar government programs in applicable jurisdictions. Each of Loan Parties and the its Subsidiaries of Borrowers is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration and Health Canada (for purposes hereof collectively, “FDA”), the Federal Trade Commission (for purposes hereof, “FTC”), the Consumer Product Safety Commission, the United States Customs Service and the United States Postal Service and other state, national, provincial or federal regulatory authorities or jurisdictions in which such Loan Party or any of Borrowers’ 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 Effect. Neither the FDA FDA, the FTC, 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, would reasonably be expected to constitute a Material Adverse Effect or (b) with which Loan Parties and their Subsidiaries of Borrowers have not complied within the time period allowed, except where any such failure would not reasonably be expected to have a Material Adverse Effect.

Other Regulatory Protection. Except As of the Closing Date, except for oxygen products, none of the Loan Parties nor any Subsidiary of any Borrower and their Subsidiaries manufactures pharmaceutical products. Except as set forth on Schedule 5.28As of the Closing Date, none of the Loan Parties and none of the their Subsidiaries of Borrowers (a) participates in Medicare or Medicaid or other similar government programs in applicable jurisdictions as a provider or supplier, rather, the Loan Parties and the their Subsidiaries of Borrowers are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program or other similar government programs in applicable jurisdictionsProgram, (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 or other similar government programs in applicable jurisdictionsProgram. Each of the Loan Parties and the its Subsidiaries of Borrowers is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration and Health Canada (for purposes hereof collectively, “"FDA”"), the Federal Trade Commission (for purposes hereof"FTC"), “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, national, provincial state or federal regulatory authorities or jurisdictions in which such Loan Party or any of Borrowers’ its Subsidiaries do business or distribute and market products, except to the extent that any such noncompliance, individually or in the aggregate, does could not constitute reasonably be expected to have a Material Adverse Effect. Neither the FDA FDA, the FTC, OSHA, the Consumer Product Safety Commission, nor any other such regulatory authority has requested (or, to the knowledge of any authorized officerResponsible Officer, are considering requesting) any product recalls or other enforcement actions that (a) if not complied 141 [Published CUSIP Number: ____] with, individually or in the aggregate, would could reasonably be expected to constitute result in a Material Adverse Effect or (b) with which the Loan Parties and their Subsidiaries of Borrowers have not complied within the time period allowed, except where any such failure would not reasonably be expected to have a Material Adverse Effect.

Other Regulatory Protection. Except for oxygen products, none of Loan Parties nor any Subsidiary of any Borrower manufactures pharmaceutical products. Except as set forth on Schedule 5.28, none of Loan Parties and none of the Subsidiaries of Borrowers (a) participates in Medicare or Medicaid or other similar government programs in applicable jurisdictions as a provider or supplier, rather, Loan Parties and the Subsidiaries of Borrowers are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program or other similar government programs in applicable jurisdictions, (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 or other similar government programs in applicable jurisdictions. Each of Loan Parties and the Subsidiaries of Borrowers is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration and Health Canada (for purposes hereof collectively, “"FDA”"), the Federal Trade Commission (for purposes hereof, “"FTC”"), the Consumer Product Safety Commission, the United States Customs Service and the United States Postal Service and other state, national, provincial or federal regulatory authorities or jurisdictions in which such Loan Party or any of Borrowers’ ' 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 Effect. Neither the FDA , the FTC, 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, would reasonably be expected to constitute a Material Adverse Effect or (b) with which Loan Parties and Subsidiaries of Borrowers have not complied within the time period allowed, except where any such failure would not reasonably be expected to have a Material Adverse Effect.

Other Regulatory Protection. Except for oxygen products, none (a) As of Loan Parties nor any Subsidiary of any Borrower manufactures pharmaceutical products. Except as set forth on Schedule 5.28, none of Loan Parties and the Effective Date, (i) none of the Subsidiaries Orthofix Entities manufactures pharmaceutical products and each Orthofix Entity is in compliance in all material respects with all applicable rules, regulations and other requirements of Borrowers the FDA, the FTC, OSHA the Consumer Product Safety Commission, the U.S. Customs Service and the U.S. Postal Service and all other state, federal or foreign regulatory authorities, or jurisdictions in which any of the Orthofix Entities do business or distribute and market products, and First Amended and Restated Credit Agreement (aOrthofix), Page 84 (ii) participates in Medicare or Medicaid 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 Responsible Officer, are considering requesting) any product recalls or other similar government programs in applicable jurisdictions as a provider or supplier, rather, Loan Parties and the Subsidiaries of Borrowers are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program or other similar government programs in applicable jurisdictions, enforcement actions. (b) is a party to any Medicare Provider Agreement or Medicaid Provider Agreement, or On each date after the Effective Date, (ci) bills for items or services to any Medical Reimbursement Program or other similar government programs in applicable jurisdictions. Each none of Loan Parties the Orthofix Entities manufactures pharmaceutical products and the Subsidiaries of Borrowers each Orthofix Entity is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration and Health Canada (for purposes hereof collectively, “FDA”), the Federal Trade Commission (for purposes hereofFTC, “FTC”), OSHA the Consumer Product Safety Commission, the United States U.S. Customs Service and the United States U.S. Postal Service and all other state, nationalfederal or foreign regulatory authorities, provincial or federal regulatory authorities or jurisdictions in which such Loan Party or any of Borrowers’ Subsidiaries the Orthofix Entities do business or distribute and market products, except to the extent that any such noncompliance, individually or in the aggregate, does could not constitute reasonably be expected to have a Material Adverse Effect. Neither , and (ii) neither the FDA FDA, the FTC, OSHA, the Consumer Product Safety Commission, nor any other such regulatory authority has requested (or, to the knowledge of any authorized officerResponsible Officer, are considering requesting) any product recalls or other enforcement actions that (a) if not complied with, individually or in the aggregate, would could reasonably be expected to constitute result in a Material Adverse Effect or and (b) with which Loan Parties and Subsidiaries of Borrowers the Orthofix Entities have not complied within the time period allowed, except where any such failure would not reasonably be expected to have a Material Adverse Effect.

Other Regulatory Protection. Except (i) Each Orthofix Entity is, and for oxygen productsthe past three (3) years has been, none of Loan Parties nor any Subsidiary of any Borrower manufactures pharmaceutical products. Except as set forth on Schedule 5.28, none of Loan Parties and none of the Subsidiaries of Borrowers (a) participates in Medicare or Medicaid or other similar government programs in applicable jurisdictions as a provider or supplier, rather, Loan Parties and the Subsidiaries of Borrowers are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program or other similar government programs in applicable jurisdictions, (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 or other similar government programs in applicable jurisdictions. Each of Loan Parties and the Subsidiaries of Borrowers is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration and Health Canada (for purposes hereof collectively, “FDA”), the Federal Trade Commission (for purposes hereofFTC, “FTC”), OSHA the Consumer Product Safety Commission, the United States U.S. Customs Service and the United States U.S. Postal Service and all other state, nationalfederal or foreign regulatory authorities, provincial or federal regulatory authorities or jurisdictions in which such Loan Party or any of Borrowers’ Subsidiaries the Orthofix Entities 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 Effect. Neither the FDA , the FTC, 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, would reasonably be expected to constitute a Material Adverse Effect or (b) with which Loan Parties and Subsidiaries of Borrowers have not complied within the time period allowed, except where any such failure would could not reasonably be expected to have a Material Adverse Effect; (ii) the manufacture, testing, development, sale, marketing, packaging, processing, use, distribution, storage, import, export or disposal of all Products are being, and for the past three (3) years have been, conducted in compliance with all applicable Health Care Laws, except to the extent that any such noncompliance, individually or in the aggregate, could not reasonably be expected to have a Material Adverse Effect; (iii) during the past three (3) years, no Orthofix Entity has had any Product manufacturing site (whether owned by such Orthofix Entity, or that of a contract manufacturer for a Product) subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form-483 or comparable written notice of inspectional observations, warning letters, untitled letters or requests or requirements to make material changes to any Products, or similar written correspondence or written notice from the FDA or other Governmental Authority alleging or asserting material noncompliance with any applicable Health Care Law, Health Care Permit or any such requests or requirements of a Governmental Authority, and, to the knowledge of any Loan Party, neither the FDA nor any other Governmental Authority has threatened such action; and (iv) during the past three (3) years there have been no material (voluntary or mandatory) recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance (collectively “Safety Notices”) with respect any Products, and to the knowledge of any Loan Party, there are no facts that would be reasonably likely to result in (x) a material Safety Notice with respect to any Product, (y) a material adverse change in labeling of any Product; or (z) a termination or suspension of marketing or testing of any Product. (v) All clinical or preclinical studies, tests or trials that have been or are being conducted by or on behalf of, or sponsored by any Orthofix Entity, or in which any Orthofix Products have participated, and which have been or will be submitted to the FDA or other regulatory authorities in connection with applications for Health Care Permits, were and, if still pending, are being conducted in compliance in all material respects with all applicable Health Care Laws any other rules, regulations, protocols and policies to which they are subject. No investigational device exemption or other approval or allowance to commence a human clinical trial filed with or submitted to the FDA or other Governmental Authority by or on behalf of any Orthofix Entity has been terminated or suspended, and neither the FDA nor any applicable Governmental Authority has commenced, or to the knowledge of any Loan Party, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of any Orthofix Entity.

Other Regulatory Protection. Except for oxygen products, none (a) As of Loan Parties nor any Subsidiary of any Borrower manufactures pharmaceutical products. Except as set forth on Schedule 5.28, none of Loan Parties and the Effective Date, (i) none of the Subsidiaries Orthofix Entities manufactures pharmaceutical products and each Orthofix Entity is in compliance in all material respects with all applicable rules, regulations and other requirements of Borrowers the FDA, the FTC, OSHA the Consumer Product Safety Commission, the U.S. Customs Service and the U.S. Postal Service and all other state, federal or foreign regulatory authorities, or jurisdictions in which any of the Orthofix Entities do business or distribute and market products, and (aii) participates in Medicare or Medicaid 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 Responsible Officer, are considering requesting) any product recalls or other similar government programs in applicable jurisdictions as a provider or supplierenforcement actions. Credit Agreement (Orthofix), rather, Loan Parties and the Subsidiaries of Borrowers are manufacturers and sell to providers for purposes of Medicare, Medicaid and any other Medical Reimbursement Program or other similar government programs in applicable jurisdictions, Page 59 (b) is a party to any Medicare Provider Agreement or Medicaid Provider Agreement, or On each date after the Effective Date, (ci) bills for items or services to any Medical Reimbursement Program or other similar government programs in applicable jurisdictions. Each none of Loan Parties the Orthofix Entities manufactures pharmaceutical products and the Subsidiaries of Borrowers each Orthofix Entity is in compliance with all applicable rules, regulations and other requirements of the Food and Drug Administration and Health Canada (for purposes hereof collectively, “FDA”), the Federal Trade Commission (for purposes hereofFTC, “FTC”), OSHA the Consumer Product Safety Commission, the United States U.S. Customs Service and the United States U.S. Postal Service and all other state, nationalfederal or foreign regulatory authorities, provincial or federal regulatory authorities or jurisdictions in which such Loan Party or any of Borrowers’ Subsidiaries the Orthofix Entities do business or distribute and market products, except to the extent that any such noncompliance, individually or in the aggregate, does could not constitute reasonably be expected to have a Material Adverse Effect. Neither , and (ii) neither the FDA FDA, the FTC, OSHA, the Consumer Product Safety Commission, nor any other such regulatory authority has requested (or, to the knowledge of any authorized officerResponsible Officer, are considering requesting) any product recalls or other enforcement actions that (a) if not complied with, individually or in the aggregate, would could reasonably be expected to constitute result in a Material Adverse Effect or and (b) with which Loan Parties and Subsidiaries of Borrowers the Orthofix Entities have not complied within the time period allowed, except where any such failure would not reasonably be expected to have a Material Adverse Effect.