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.
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2
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.
Sample 1Sample 2

More Definitions of Marketing Authorization Data

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 ...
Sample 1

Related to Marketing Authorization Data

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

  • 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 Standard Body necessary for the 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, 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 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.

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

  • 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.

  • 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 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.

  • 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.

  • 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 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 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 a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • 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 as set out in Schedule C hereto;

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • 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.