Material Regulatory Authorizations definition

Material Regulatory Authorizations means any Regulatory Authorizations where the failure to possess or maintain such Regulatory Authorization, or restrictions placed thereon, in either case, could reasonably be expected, either individually or in the aggregate, to result in either (a) a material adverse effect on any Product Development and Commercialization Activities associated with any Product or (b) a Material Adverse Effect.
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Examples of Material Regulatory Authorizations in a sentence

  • The Material Regulatory Authorizations issued by the FDA and other Regulatory Agencies for the Products are, in all material respects, valid and supported by proper research, design, testing, analysis and disclosure.

  • The Borrower and its Subsidiaries have obtained all Material Regulatory Authorizations necessary for compliance with all Laws and all such Material Regulatory Authorizations are in full force and effect.

  • The transactions contemplated by the Loan Documents will not (i) constitute a breach or violation of, or otherwise materially affect, the enforceability or approval of any Material Regulatory Authorization relating to the Products or (ii) impair the Loan Parties’ ownership of or rights under (or the license or other right to use, as the case may be) any Material Regulatory Authorizations in any material manner.

Related to Material Regulatory Authorizations

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Authority means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory.

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession other than the U.S.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

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