Application for Marketing Authorization definition

Application for Marketing Authorization means, with respect to a Licensed Product, (i) in the United States, a New Drug Application filed with the FDA pursuant to 21 U.S.C. Section 355 and 21 C.F.R. Section 314 or any successor regulatory scheme (“NDA”), and (ii) in any country other than the United States, an application or set of applications for marketing approval comparable to an NDA and necessary to make and sell Licensed Products commercially in such country.
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Application for Marketing Authorization means, with respect to Product, (a) in the United States, a New Drug Application filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314 (“NDA”), and (b) in any country other than the United States, an application or set of applications for marketing approval comparable to an NDA necessary to market and sell Product commercially in such country.
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Application for Marketing Authorization means, with respect to Product, (i) in the United States, a Biologics License Application (“BLA”) or a New Drug Application (“NDA”) filed with the FDA for marketing approval of a Product, or any equivalent applications or procedures under any successor regulatory scheme, and (ii) in any country other than the United States, an application or set of applications for marketing approval comparable to an NDA or BLA and necessary to sell Product commercially in such country.
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Examples of Application for Marketing Authorization in a sentence

  • For clarity, as set forth above Vendor shall have no rights with respect to any Application for Marketing Authorization.

  • Notwithstanding the foregoing, prior to filing with the applicable Regulatory Authorities, Keryx will provide to Vendor a redacted copy of the Product portion of such Application for Marketing Authorization and supporting documents.

  • As between the Parties, Keryx shall have the sole right and responsibility to prepare and file an Application for Marketing Authorization, including the CMC, with the applicable Regulatory Authorities, and, for clarity, including responding to any questions and inquires of the Regulatory Authority subsequent to filing.

  • This disclosure will permit Vendor to verify that the Application for Marketing Authorization accurately describes the Manufacturing Procedure that Vendor will perform under this Agreement.

  • CMC shall mean the chemistry, manufacturing, and controls section(s) and data in any Application for Marketing Authorization that covers the chemical composition of a given Product and its components and the control and manufacturing process for any Products and their components, as may be amended or supplemented from time to time.


More Definitions of Application for Marketing Authorization

Application for Marketing Authorization means (a) in the United States a new drug application filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314 ("NDA") with respect to the Product and (b) in any country other than the United States, an equivalent application or set of applications for marketing approval comparable to an NDA necessary to make and sell Product commercially in such country.
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Application for Marketing Authorization means, with respect to a Licensed Product, (a) in the United States, a New Drug Application filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314 (“NDA”), and (ii) in any country other than the United States, an application or set of applications for marketing approval comparable to an NDA necessary to make and sell Licensed Product commercially in such country. 1.6 “Biological Materials” means PLA2 related biological reagents such as DNA, RNA, proteins, antibodies, cells, chromogenic indicators, substrates, and purified sPLA2 and cPLA2. 1.7 “Claims” has the meaning set forth in Section 6.1.
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Application for Marketing Authorization means, with respect to the Product in any country or region, an application or set of applications filed with the applicable Regulatory [*] = Indicates confidential information omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Authority to make and sell Product commercially in such country or region, comprising an NDA in the United States and an application comparable to an NDA in any other country or region.
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Application for Marketing Authorization means (i) in the United States, a BLA filed with the FDA with respect to Product, and (ii) in any country other than the United States, an application or set of applications for marketing approval comparable to a BLA.
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Related to Application for Marketing Authorization

  • 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 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 Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • 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.

  • 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.

  • 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, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • 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 Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

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

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

  • FDA means the United States Food and Drug Administration.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Pricing Approval means such mandatory governmental approval, agreement, determination or decision establishing prices for the Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

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

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • 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 set out in Schedule C hereto;

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

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • 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.

  • Commercial or marketing purpose means the sale of student data; or its use or disclosure for purposes of receiving remuneration, whether directly or indirectly; the use of student data for advertising purposes, or to develop, improve, or market products or services to students.

  • 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.