Healthcare Regulatory Authorizations definition

Healthcare Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Healthcare Regulatory Authority, including all investigational new drug applications and new drug applications.
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Healthcare Regulatory Authorizations means authorizations, applications, approvals, accelerated approvals, clearances, registrations, licenses, permits, certificates or exemptions or other evidence of authority issued or recognized by any applicable Governmental Entity (including New Drug Applications and Investigational New Drug Applications) required for the research, development, testing, manufacture, processing, handling, packaging, labeling, storage, advertising, promotion, marketing, sale or distribution of the Products.
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Healthcare Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Healthcare Regulatory Authority.
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Examples of Healthcare Regulatory Authorizations in a sentence

  • The Tag shall be securely affixed to a collar, harness or other device which shall be worn on the Animal for which it was issued at all times, when off the property of the Owner.

  • Except as, individually or in the aggregate, has not had and would not reasonably be expected to have a Company Material Adverse Effect, the Company and each of the Company Subsidiaries is, and has since January 1, 2019 been, in compliance with (i) all applicable Healthcare Laws and (ii) all Healthcare Regulatory Authorizations.

  • Except as would not, individually or in the aggregate, reasonably be expected to have a Parent Material Adverse Effect, Parent and each of the Parent Subsidiaries is and has been since January 1, 2019, in compliance in all material respects with (i) all applicable Healthcare Laws and (ii) all Healthcare Regulatory Authorizations.

  • Since January 1, 2019, neither the Company nor any of the Company Subsidiaries has received, (i) from FDA, any FDA Form 483, warning letter or untitled letter or (ii) from any other Healthcare Regulatory Authority, any similar written notice alleging or asserting material noncompliance with any Healthcare Laws or Healthcare Regulatory Authorizations held by Company or any of the Company Subsidiaries.

  • Since January 1, 2011, the Company and the Company Subsidiaries have held all material Healthcare Regulatory Authorizations required for the conduct of their respective businesses and all such Healthcare Regulatory Authorizations are and have been in full force and effect.

  • Amneal and each of its Subsidiaries is and has been since January 1, 2014, in compliance in all material respects with (i) all Healthcare Laws and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, and all other Healthcare Regulatory Authorities, that are applicable to Amneal or its Subsidiaries, as applicable.

  • Impax and each of its Subsidiaries is and has been since January 1, 2014, in compliance in all material respects with (i) all Healthcare Laws and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, and all other Healthcare Regulatory Authorities, that are applicable to Impax or its Subsidiaries, as applicable.

  • Amneal and each of its Subsidiaries, as applicable, has held, or has held contractual rights to, all material Healthcare Regulatory Authorizations required for the marketing and approval of all products marketed by or on behalf of Amneal or any of its Subsidiaries, and all such Healthcare Regulatory Authorizations are in full force and effect.

  • Impax and each of its Subsidiaries, as applicable, has held, or has held contractual rights to, all material Healthcare Regulatory Authorizations required for the marketing and approval of all products marketed by or on behalf of Impax or any of its Subsidiaries, and all such Healthcare Regulatory Authorizations are in full force and effect.

  • Since January 1, 2019, neither Parent nor any Parent Subsidiary has received, (i) from FDA, any FDA Form 483, warning letter or untitled letter or (ii) from any other Healthcare Regulatory Authority, any similar written notice alleging or asserting material noncompliance with any Healthcare Laws or Healthcare Regulatory Authorizations held by Parent or any Parent Subsidiaries.


More Definitions of Healthcare Regulatory Authorizations

Healthcare Regulatory Authorizations means (a) all Permits required to be held pursuant to any Healthcare Law by any Patient Service Provider and (b) all applicable licenses, registrations, approved marketing authorizations including New Drug Applications, Biologics License Applications, cleared premarket notifications and Premarket Applications for medical device products, in-effect Investigational New Drug Applications or similar authorizations to conduct human clinical trials, approvals by an Institutional Review Board or similar entity to conduct human clinical studies, new dietary ingredient notifications submitted to and not objected to by the FDA, Drug Enforcement Agency registrations, state and municipal drug or medical device manufacturing or distribution licenses, and any other permit, license or other form of authorization required under the Healthcare Laws.
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Healthcare Regulatory Authorizations means all approvals, clearances, authorizations, medical device licenses, consents, waivers, registrations, certificates, licenses and permits granted by or required by any Healthcare Regulatory Authority and necessary to market and sell Revogene assays, instruments related to the Business in Canada, the United States and Europe, including participation agreements with governmental third-party payors, including by way of example, Medicare, Medicare Advantage, Medicaid, Tricare, FEHBP and any “federal health care program,” as that term is defined in Social Security Act § 112B(f), quality management system certificates and International Organization of Standardization (ISO) certificates.
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Healthcare Regulatory Authorizations means any Governmental Authorizations required by the Company or any of the Company Subsidiaries to conduct its respective business under applicable Healthcare Laws, including without limitation, any such Governmental Authorizations required for the testing, manufacturing, marketing, promotion, sale, distribution, packaging, storage, export or import, of any Company Product.
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Healthcare Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Healthcare Regulatory Authority, including all investigational new drug applications and new drug applications. As used herein, “Product Candidates” means pharmaceuticals, cosmaceuticals, compounds or other products under development, current, active or otherwise, or consideration by the Company or any of its licensees.
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Related to Healthcare Regulatory Authorizations

  • Regulatory Authorities means the Commissions and the Exchange;

  • Cemetery authority means any person who owns or operates a cemetery specified in s. 157.065 (1).

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory agencies, departments, bureaus, commissions, councils, or other government entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of Products.

  • Healthcare Laws has the meaning provided in Section 5.19(a).

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Approvals means all licenses, permits, approvals, certificates and other authorizations granted or issued by any Governmental Authority for the matter or item in question.

  • Public Procurement Regulatory Authority (PPRA) means the Government Agency responsible for oversight of public procurement.