Marketing Authorization Data definition

Marketing Authorization Data means the existing and available dossiers containing the Know-How used by Novartis and/or its Affiliates to obtain and maintain the Marketing Authorizations.
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Marketing Authorization Data means the existing and available data in Novartis’ or its Affiliates possession and reasonably accessible to Novartis and/or its Affiliate; (a) that has been provided by Novartis to the Regulatory Authority in Switzerland in relation to the Swiss Marketing Authorisation; (b) that has been provided to the Regulatory Authority in China related to the IDL. CMS: We hope to add that the data described in (a) include without limitation to CTD documents (containing API and preparation, M1, M2, M3, M4, M5), application for changes, Periodic Safety Update Reports, etc. which are submitted to the regulatory authorities in Switzerland by Novartis; data in (b) include the entire set of registration dossiers, all previous documents for changes application and re-registration dossiers, and the detailed list can be attached in the annexes.
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Marketing Authorization Data means the existing dossiers, in the form currently maintained in the Books and Records of Novartis and/or its Affiliates used by Novartis and/or its Affiliates to obtain and maintain the Marketing Authorizations.
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More Definitions of Marketing Authorization Data

Marketing Authorization Data means the existing and available dossiers containing the relevant Know-How used by Novartis and/or its Affiliates solely to obtain and maintain the Marketing Authorizations.
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Marketing Authorization Data means the existing dossiers, in the form currently maintained in the Books and Records of Novartis and/or its Affiliates used by Novartis and/or its Affiliates to obtain and maintain the Marketing Authorizations. “Marketing Authorization Plan” shall have the meaning set forth in Clause 5.1(a). “Marketing Authorizations” means the marketing authorizations or any equivalent regulatory approvals listed in Annex 3 for the Product in the Territory. “Material Adverse Effect” means [***]. “MA Transfer Date” means, in relation to each country of the Territory, the date upon which the relevant Regulatory Authority approves and notifies the Marketing Authorization, naming the Purchaser or the Purchaser’s Affiliate or designate as the marketing authorization holder. “Medical Information” means any medical or clinical information related to the Product owned by and used by Novartis, in the form currently maintained in the Books and Records of Novartis and/or its Affiliates, at the Closing Date, including clinical and technical matters, such as therapeutic uses for the approved indications, drug‑disease information, and other product characteristics. “Milestone Payments” shall have the meaning set forth in Clause 9.2. “NAG” shall have the meaning set forth in the Preamble. “Non-transferred Marketing Authorizations” shall have the meaning set forth in Clause 5.1(b). “Novartis” shall have the meaning set forth in the Preamble. “NPAG” shall have the meaning set forth in the Preamble. “Omitted Transferred Asset” shall have the meaning set forth in Clause 5.3. “Party” and “Parties” shall have the meanings set forth in the Preamble. “PDL” means PDL BioPharma, Inc., a Delaware corporation. “Permits” means all licenses, permits, approvals or authorizations of any Governmental Entity with respect to manufacturing of the Drug Substance or the Product. 7 [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions “Permitted Encumbrance” means (i) liens for taxes or governmental assessments not yet due and payable or for taxes or governmental assessments being contested in good faith through appropriate proceedings for which adequate accruals or reserves have been established in the audited financial statements of Novartis and (ii) mechanics’, carriers’, workers’, repairers’ and similar statutory liens arising or incurred in the ordinary ...
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Related to Marketing Authorization Data

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

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • 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 Regulatory Agency necessary for the preclinical or clinical testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • 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 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 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).

  • 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.

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

  • 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 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.

  • 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.

  • Product Approval(s) 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 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 Authorities means the Commissions and the Exchange;

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

  • 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.

  • 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).

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • 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;

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or 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.