Marketing Authorization Application(s) definition

Marketing Authorization Application(s) means any or all applications to a Regulatory Authority in the Territory in order to obtain Marketing Authorization.
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Examples of Marketing Authorization Application(s) in a sentence

  • MorphoSys (and its Affiliates and Sublicensees) shall have the right to file in its own name, and to own, all new INDs, Marketing Authorization Applications and Marketing Authorizations for Licensed Products in the MorphoSys Territory for the Field and may delegate and/or assign these rights to Affiliates and Sublicensees.

  • The terms of confidentiality respecting Information shall not impede the appropriate use thereof in IMPATIENTS’s submission of Information in Early Access Approvals applications with Regulatory Authorities, in HEMISPHERX’s submission of Information in Marketing Authorization Applications with Regulatory Authorities, or in execution of the EAP of Product according to the EAP Plan.

  • JT shall have the right to file and own Marketing Authorization Applications and Regulatory Approval for Products in Japan until MAH Transfer Date to the extent contemplated by the Master Agreement or Ancillary Agreements.

  • Collaborator shall be responsible for preparing any and all Regulatory Materials to be used for filing with Regulatory Authority in the Licensed Territory and for filing CTAs, INDs or their equivalent in the Licensed Territory, Marketing Authorization Applications, Pricing Approval applications and all other applications in connection with seeking Regulatory Approvals for the Products in the Licensed Territory.

  • Following the transfer of ownership provided in Section 2.1, above, all Marketing Authorization Applications shall be filed and maintained in the name of GS and GS shall be the owner of all resulting Regulatory Approvals.

  • In the event of such a termination, Gilead, its Affiliates and Sublicensees shall take all actions reasonably necessary to effect such transfer of such INDs, Marketing Authorization Applications and Regulatory Approvals for [*] in the Gilead Original Territory if this Agreement is terminated with respect to the Gilead Original Territory in whole, or in a Reverted Country if this Agreement is terminated in part.

  • Through meetings of the Steering Committee, GS shall: (i) keep LGLS informed regarding the schedule and progress for the preparation and submission of Marketing Authorization Applications in the Territory, and (ii) permit LGLS a reasonable opportunity to comment on such Marketing Authorization Applications.

  • The file is under review The Marketing Authorization Applications (MAAs) for proposed biosimilar Trastuzumab and Pegfilgrastim have been accepted by the European Medicines Agency (EMA) and are under active review.

  • GS shall be promptly notified of any proposed change in the process for the manufacture of Product pursuant to this Article 5 which potentially impacts the Marketing Authorization Applications or Regulatory Approval in the Territory including, without limitation, any proposed change as to the site at which such manufacture is to occur.

  • Upon notice by GS pursuant to this Section 13.4, this Agreement and all obligations of LGLS and GS hereunder with respect to the country or countries in question shall terminate and GS shall promptly transfer to LGLS all Marketing Authorization Applications and Regulatory Approvals and the Trademarks with respect to the country or countries in question, as well as all other Information and know-how related to such country or countries.

Related to Marketing Authorization Application(s)

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • 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).

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

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • 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.

  • 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 or use of a Product as a drug in a regulatory jurisdiction.

  • 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.

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

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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 Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

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

  • 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.

  • 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;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • 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.

  • 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.

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • 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 Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

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

  • Government Authorizations means all such approvals, consents, authorizations, acknowledgements, licenses or permits required to be issued by any Government Authority to the Company for the establishment of the Company or to the Company or the Contractors for the construction, financing, ownership, operation, and maintenance of the Facility by the Company or the Contractors, including, without limitation, those Government Authorizations listed in Schedule 1;

  • Federal work authorization program means any of the electronic verification of work authorization programs operated by the United States Department of Homeland Security or any equivalent federal work authorization program operated by the United States Department of Homeland Security to verify information of newly hired employees, pursuant to the Immigration Reform and Control Act of 1986 (IRCA), D.L. 99-603.