Common use of Health Care Authorizations Clause in Contracts

Health Care Authorizations. The Company and each of the Subsidiaries has submitted and possesses, or qualifies for applicable exemptions to, such valid and current material registrations, listings, approvals, clearances, licenses, certificates, authorizations, accreditations, provider or supplier numbers, or permits and supplements or amendments thereto issued or required by the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct their business, including, without limitation, all such material registrations, listings, approvals, clearances, licenses, certificates, authorizations, accreditations, exemptions, provider or supplier numbers, or permits and supplements or amendments thereto required by the United States Food and Drug Administration (the “FDA”), the United States Department of Health and Human Services (“HHS”), the United States Centers for Medicare & Medicaid Services (“CMS”), the European Medicines Agency (the “EMA”), Health Canada or any other state, federal or foreign agencies or bodies engaged in the regulation of medical devices (including diagnostic products, such as laboratory developed tests), drugs, biologics or biohazardous materials (the “Regulatory Agencies”) (collectively, “Regulatory Licenses”), and except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus: (i) the Company, each of its Subsidiaries and Xxxxxxxx Pathology, LLP d/b/a Avero Diagnostics (“Managed Practice”) has fulfilled and performed all of its obligations with respect to each Regulatory License and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Regulatory License, and (ii) none of the Company, any of the Subsidiaries or the Managed Practice has received any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such Regulatory License, the lack of which would not, individually or in the aggregate, have a Material Adverse Effect.

Health Care Authorizations. The Company and each of the Subsidiaries has submitted and possesses, or qualifies for applicable exemptions to, such valid and current material registrations, listings, approvals, clearances, licenses, certificates, authorizations, accreditations, provider or supplier numbers, or permits and supplements or amendments thereto issued or required by the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct their business, including, without limitation, all such material registrations, listings, approvals, clearances, licenses, certificates, authorizations, accreditations, exemptions, provider or supplier numbers, or permits and supplements or amendments thereto required by the United States Food and Drug Administration (the “FDA”), the United States Department of Health and Human Services (“HHS”), the United States Centers for Medicare & Medicaid Services (“CMS”), the European Medicines Agency (the “EMA”), Health Canada or any other state, federal or foreign agencies or bodies engaged in the regulation of medical devices (including diagnostic products, such as laboratory developed tests), drugs, biologics or biohazardous materials (the “Regulatory Agencies”) (collectively, “Regulatory Licenses”), and except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus: (i) the Company, each of its Subsidiaries and Xxxxxxxx Pathology, LLP d/b/a Avero Diagnostics (“Managed Practice”) has fulfilled and performed all of its obligations with respect to each Regulatory License and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Regulatory License, and (ii) none of the Company, any of the Subsidiaries or the Managed Practice has received any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such Regulatory License, the lack of which would not, individually or in the aggregate, have a Material Adverse Effect.

Health Care Authorizations. The Company and each of the Subsidiaries has submitted and possesses, or qualifies for applicable exemptions to, such valid and current material registrations, listings, approvals, clearances, licenses, certificates, authorizations, accreditations, provider or supplier numbers, or permits and supplements or amendments thereto issued or required by the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct their business, including, without limitation, all such material registrations, listings, approvals, clearances, licenses, certificates, authorizations, accreditations, exemptions, provider or supplier numbers, or permits and supplements or amendments thereto required by the United States Food and Drug Administration (the “FDA”), the United States Department of Health and Human Services (“HHS”), the United States Centers for Medicare & Medicaid Services (“CMS”), the European Medicines Agency (the “EMA”), Health Canada or any other state, federal or foreign agencies or bodies engaged in the regulation of medical devices (including diagnostic products, such as laboratory developed tests), drugs, biologics or biohazardous materials (the “Regulatory Agencies”) (collectively, “Regulatory Licenses”), and except as disclosed in the Registration Statement, the Time of Sale Disclosure Package Statement and the Prospectus: (i) the Company, each of its Subsidiaries and Xxxxxxxx Pathology, LLP d/b/a Avero Diagnostics (“Managed Practice”) has fulfilled and performed all of its obligations with respect to each Regulatory License and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Regulatory License, and (ii) none of the Company, any of the Subsidiaries or the Managed Practice has received any notice of proceedings relating to the revocation or modification of, or non-compliance with, any such Regulatory License, the lack of which would not, individually or in the aggregate, have a Material Adverse Effect.

Health Care Authorizations. The Company and each (i) has at all times been in compliance, in all material respects, with all statutes, rules or regulations of the Subsidiaries has U.S. Food and Drug Administration (the “FDA”), the U.S. Department of Health and Human Services (“HHS”), the U.S. Centers for Medicare & Medicaid Services (“CMS”), the European Medicines Agency (“EMA”), Health Canada or any other comparable state, federal or foreign agencies or bodies to which it is subject (collectively, the “Applicable Agencies”), (ii) submitted and possesses, or qualifies for applicable exemptions to, such valid and current material registrations, listings, approvals, clearances, licenses, certificates, authorizations, accreditations, provider or supplier numbers, authorizations or permits and supplements or amendments thereto issued or required by the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct their businessits business (“Permits”), including, without limitation, all such Permits required by the Applicable Agencies, except where the failure to so possess such Permits, singly or in the aggregate, would not reasonably be expected to have a Material Adverse Effect, and such Permits are valid and in full force and effect and the Company is not in violation, in any material registrationsrespect, listingsof any term of any such Permits, approvals(iii) has filed, clearancesmaintained or submitted all material reports, licensesdocuments, certificatesforms, authorizationsnotices, accreditationsapplications, exemptionsrecords, provider or supplier numbersclaims, or permits submissions and supplements or amendments thereto as required by the United States Food Applicable Agencies or Permits or Health Care Laws (as defined below) and Drug Administration that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and accurate on the date filed (the “FDA”), the United States Department of Health or were materially corrected or supplemented by a subsequent submission) and Human Services (“HHS”), the United States Centers for Medicare & Medicaid Services (“CMS”), the European Medicines Agency (the “EMA”), Health Canada or any other state, federal or foreign agencies or bodies engaged in the regulation of medical devices (including diagnostic products, such as laboratory developed tests), drugs, biologics or biohazardous materials (the “Regulatory Agencies”) (collectively, “Regulatory Licenses”), and except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus: (iiv) the Company, each of its Subsidiaries and Xxxxxxxx Pathology, LLP d/b/a Avero Diagnostics (“Managed Practice”) Company has fulfilled and performed all of its obligations with respect to each Regulatory License and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Regulatory License, and (ii) none of the Company, any of the Subsidiaries or the Managed Practice has not received any notice of proceedings relating to the revocation revocation, suspension or modification of, or non-compliance with, any such Regulatory LicensePermit, except for such Permits, the lack of which would not, individually or in the aggregate, have result in a Material Adverse Effect.