Regulatory Approvals or Licensures definition

Regulatory Approvals or Licensures means all U.S., EU, UK and any other foreign approvals, exclusivities, authorizations, licensure or clearances (including approval under FDCA §§ 505 or 515 and clearance under FDCA § 510(k)); licensures (including Orphan Drug exclusive approval under 21 C.F.R. § 316.34 or any foreign equivalents); designations (including (i) Orphan Drug designation under 21 C.F.R. § 316.24 or any foreign equivalents); (ii) Fast Track designation, Breakthrough Therapy designation, and Priority Review designation under 21 U.S.C. § 356 and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents); and (iii) Qualified Infectious Disease Product designation under 21 U.S.C. § 355f (including an award of “GAIN” exclusivity) and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents); and any product or establishment licenses, registrations, approvals, or authorizations of any Regulatory Agency necessary for the manufacture, use, import, export, storage, transport, offer for sale, or distribution or sale of Product.
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Regulatory Approvals or Licensures means all U.S., Canada, EU, UK and any other foreign approvals, exclusivities, authorizations, designations, licensures or clearances (including approval under FDCA § 505 or Orphan Drug exclusive approval under 21 C.F.R. § 316.34 or any foreign equivalents); Orphan Drug designation under 21 C.F.R. § 316.24 or any foreign equivalents); Fast Track designation, Breakthrough Therapy designation, and Priority Review designation under 21 U.S.C. § 356 and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents); and Qualified Infectious Disease Product designation under 21 U.S.C. § 355f (including an award of “GAIN” exclusivity) and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents)); and any product or establishment licenses, approvals, registrations or authorizations of any Regulatory Agency necessary for the manufacture, use, storage, import, export, transport, offer for sale or lease, distribution or sale or lease of any Product.
Sample 1
Regulatory Approvals or Licensures means all U.S., EU, U.K., and any other foreign approvals, exclusivities, authorizations, licensure, or clearances, including approval under FDCA §§ 505 or 515 clearance under FDCA § 510(k); licensure under § 351 of the Public Health Service Act; Orphan Drug designation and exclusivity (under 21 C.F.R. Part 316) and any foreign equivalents; designations including Fast Track and Breakthrough Therapy designations (under FDCA § 506), and Priority Review designation (pursuant to FDA policy or agreements) and any foreign equivalents; Accelerated Approval (under 21 C.F.R. part 601 subpart E) and any foreign equivalents; and any product or establishment licenses, registrations, approvals, or authorizations of any Regulatory Agency necessary for the manufacture, use, import, export, storage, transport, offer for sale, or distribution or sale of Product. In each case, this definition is intended to include any corresponding statutes, regulations, and as interpreted through guidance documents by FDA (and foreign equivalents).
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Examples of Regulatory Approvals or Licensures in a sentence

  • Regulatory Approvals or Licensures ...............................................................................................

  • This organization follows a common three-tier approach to service-oriented ar- chitecture (SOA) systems.


More Definitions of Regulatory Approvals or Licensures

Regulatory Approvals or Licensures means all U.S., EU, U.K., Japanese, Australian and any other foreign approvals, exclusivities, authorizations, licensure, or clearances, including approval under FDCA §§ 505 or 515 clearance under FDCA § 510(k); licensure under § 351 of the Public Health Service Act; Orphan Drug designation and exclusivity (under 21 C.F.R. Part 316) and any foreign equivalents; designations including Fast Track, Breakthrough Therapy, and Rare Pediatric Disease designations (under FDCA §§ 506, 529), and Priority Review designation (pursuant to FDA policy or agreements) and any foreign equivalents; Accelerated Approval (under FDCA § 506) and any foreign equivalents; and any product or establishment licenses, registrations, approvals, or authorizations of any Regulatory Agency necessary for the manufacture, use, import, export, storage, transport, offer for sale, or distribution or sale of Product. In each case, this definition is intended to include any corresponding statutes, regulations, and as interpreted through guidance documents by FDA (and foreign equivalents).
Sample 1
Regulatory Approvals or Licensures means all U.S., EU, Japanese, and any other foreign approvals, exclusivities, authorizations, licensure or clearances (including approval under FDCA §§ 505 or 515 and clearance under FDCA § 510(k)); licensures (including Orphan Drug exclusive approval under 21 C.F.R. § 316.34 and any foreign equivalents); designations (including (i) Orphan Drug designation under 21 C.F.R. § 316.24 and any foreign equivalents; (ii) Fast Track designation, Breakthrough Therapy designation, and Priority Review designation under 21 U.S.C. § 356 and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents); and (iii) Qualified Infectious Disease Product designation under 21 U.S.C. § 355f (including an award of “GAIN” exclusivity) and any corresponding regulations and as interpreted through guidance documents by FDA (and foreign equivalents); and any product or establishment licenses, registrations, approvals, or authorizations of any Regulatory Agency necessary for the manufacture, use, import, export, storage, transport, offer for sale, or distribution or sale of Product.
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Related to Regulatory Approvals or Licensures

  • 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.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, 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;

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

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to: (a) general plan, general plan amendments, specific plans and specific plan amendments; (b) tentative and final subdivision and parcel maps; (c) conditional use permits and master plans; (d) zoning, zoning map amendments, and zoning text amendments; and, (e) grading and building permits.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Regulatory Laws means all Applicable Laws governing (i) the import, export, testing, investigation, manufacture, marketing or sale of the Product, (ii) establishing recordkeeping or reporting obligations, (iii) any Field Action or (iv) similar regulatory matters.

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

  • Regulatory entity means any board, commission, agency,

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Gaming Approvals means with respect to any action by a particular Person, any consent, finding of suitability, license, approval or other authorization required for such action by such Person from a Gaming Authority or under Gaming Laws.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.