Regulatory Approvals or Licensures definition

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.
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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, 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.
Sample 1

Examples of Regulatory Approvals or Licensures in a sentence

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


More Definitions of Regulatory Approvals or Licensures

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.
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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Related to Regulatory Approvals or Licensures

  • 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.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

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

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • 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.

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

  • Marketing Authorization Application or “MAA” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to any compound or product (including any Licensed Compound or Licensed Product), or its use or potential use in humans, including any documents submitted to any Regulatory Authority and all supporting data, including INDs and NDAs, and all correspondence with any Regulatory Authority with respect to such compound or product (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).

  • Drug Approval Application means an application for Regulatory Approval of a Licensed Product as a pharmaceutical product in a country in the Territory.

  • Regulatory Laws means the HSR Act, the Xxxxxxx Antitrust Act of 1890, as amended, and the rules and regulations promulgated thereunder, the Xxxxxxx Act of 1914, as amended, and the rules and regulations promulgated thereunder, the Federal Trade Commission Act of 1914, as amended, and the rules and regulations promulgated thereunder, and any other federal, state and foreign statutes, rules, regulations, orders, decrees, administrative and judicial doctrines and other Laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.

  • 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, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.