Marketing Approvals definition

Marketing Approvals means, with respect to a Licensed Product, all approvals, licenses, registrations, or authorizations, including emergency use authorizations, of the Regulatory Authorities in a country that are necessary for the commercial marketing and sale of such Licensed Product in such country, including the approval of a BLA.
Sample 1
Marketing Approvals means any and all active or inactive (i) approvals, licenses, registrations and authorizations, of all governmental agencies in a jurisdiction for the development, manufacture, use or sale of the Product in the applicable jurisdiction, including any pricing or reimbursement approval with respect to the sale of the Product in the applicable jurisdiction; and (ii) applications for any of the foregoing; in each case in countries or jurisdictions outside the Prior Territory. Schedule 1.13 attached hereto sets forth a complete list of all Marketing Approvals and the status thereof as of the Closing Date, including the date of any required renewals after the Closing Date.
Sample 1Sample 2
Marketing Approvals means any and all Approvals required for the marketing, distribution and sale of the Product in the Territory, and includes the NOC and DIN.
Sample 1

Examples of Marketing Approvals in a sentence

  • Each Party will consult with the other Party regarding (and provide copies of materials prior to any submission to a Regulatory Authority and materials after receipt from a Regulatory Authority), and keep such other Party reasonably and regularly informed of, the status of the preparation of all Regulatory Materials in the Territory, review of such materials by the relevant Regulatory Authority in the Territory, and Marketing Approvals received for the Initial POZEN Product in the Territory.

  • Genentech shall own all regulatory submissions, including all Marketing Approvals and applications therefor, for Licensed Products in the United States.

  • Subject to Sorrento’s ownership in and to the Sorrento Know-How, Servier shall own all Regulatory Materials and all correspondence with Competent Authorities for the Product in the Territory and Servier shall own and be the license holder for all Marketing Approvals, pricing and reimbursement approvals for the Product.

  • CLS agrees to have transferred any Licensed Product Marketing Approvals in the Field that are owned by CLS or its Affiliates to XBIO or its designees.

  • To the extent required by applicable Laws, including regulations promulgated by applicable securities exchange, each Party shall have the right to make a press release announcing the achievement of each milestone under this Agreement as it is achieved, and the achievements of Marketing Approvals in the Territory as they occur, subject only to the review procedure set forth in the preceding sentence.

  • Use separate sheets if required.__ in Chinese檢測病人血液樣本中，是否存在丙型肝炎的抗原。 C006Accessories and parts covered by the Marketing Approvals and Essential Principles under Note D001 of Part D.

  • UGNX hereby represents and warrants to KHK that as of the Effective Date there is no pending filing, complaint, matter or action against or involving either UGNX or its Affiliates with any Regulatory Authority that could be reasonably anticipated to have a material adverse effect on its ability to obtain Marketing Approvals and Pricing and/or Reimbursement Approvals for the Licensed Products in any country or region of the Territory or the European Territory.

  • Licensee hereby grants COH a right of reference with respect to IND [***] and the clinical trials listed on Exhibit A, including the right to reference all regulatory dossiers relating to Marketing Approvals for Licensed Products.

  • Unless otherwise mutually agreed to by the Parties, Elpiscience shall not license or authorize, under any rights owned, controlled or licensed to Elpiscience, including any rights in or to any regulatory filings, Marketing Approvals or granted by a Regulatory Authority, a Third Party to develop, market or sell a Generic Product.

  • Licensee shall have the sole authority and responsibility to obtain in its own name and maintain any Regulatory Approvals and Marketing Approvals with respect to the Licensed Product in the Territory.


More Definitions of Marketing Approvals

Marketing Approvals mean all approvals and permissions (excluding reimbursement approvals) from the Regulatory Authorities in the Territory (as defined in the Sub-License Agreement) (or parts of the Territory) that are necessary for the importation or manufacturing (if applicable) of the Products and their distribution, use, marketing, and sale in the Territory (or parts of the Territory).
Sample 1
Marketing Approvals means the approvals issued by any Agency in accordance with any procedures as may be required by Applicable Law to market the Finished Product in the relevant country.
Sample 1

Related to Marketing 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.

  • 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 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.

  • 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.

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

  • 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).

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

  • 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.

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • 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.

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

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • Gaming Approvals means with respect to any action by a particular Person, any consent, finding of suitability, license, approval or other authorization required for such action by such Person from a Gaming Authority or under Gaming Laws.

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

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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.

  • 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.

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

  • 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.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • Development approval means any written authorization from a

  • 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 Bodies means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate, investigate, or influence the matters dealt with in the Contract or any other affairs of the Authority and “Regulatory Body” shall be construed accordingly.

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.