Application for Marketing Authorization definition

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.
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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 (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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Examples of Application for Marketing Authorization in a sentence

  • Application for Marketing Authorization for Lacosamide in Japan for the Treatment of EpilepsyDaiichi Sankyo and UCB signed an agreement in November 2014 for joint commercialization of lacosamide, an epilepsy treatment developed by UCB.

  • Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any Application for Marketing Authorization.

  • The Client is solely responsibility for the preparation and filing of the Application for Marketing Authorization, and any relevant costs will be borne by the Client.

  • For application procedures refer Guidelines on Procedural Aspects for Application for Marketing Authorization of Human Pharmaceutical Products.

  • Major R&D Alliances and Status of Related Projects, etc.a. Application for Marketing Authorization for Lacosamide in Japan for the Treatment of EpilepsyDaiichi Sankyo and UCB Japan Co., Ltd.

  • 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.

  • Should Lilly elect to sublicense, or to co-market or co-promote Product with a Third Person in the Territory, pursuant to Lilly’s rights under this Section 11.3, Lilly shall have the right to provide appropriate access to such Clinical Trial data or information, Clinical Trial databases, all data generated in support of any Application for Marketing Authorization, Regulatory Approval other regulatory commitment, or Regulatory Document to such Third Person.

  • 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.

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


More Definitions of Application for Marketing Authorization

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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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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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 or a Xxxxx New Product, a New Drug Application or ANDA filed with the FDA pursuant to 21 U.S.C. Section 357 and 21 C.F.R. Section 314.
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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 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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Related to Application for Marketing Authorization

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

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

  • 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 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.

  • 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.

  • 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, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

  • 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.

  • 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 and any successor agency thereto.

  • 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 governmental approval, agreement, determination or decision establishing prices for a Licensed 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 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.

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

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

  • 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 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.