Market Authorization definition

Market Authorization means an official document issued by the Authority for the purpose of marketing or free distribution of the product in Ethiopia;
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Market Authorization means approval by one or more Regulatory Authorities to market, sell and distribute the Drug Product in any part of the world.
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Market Authorization means that specific Regulatory Approval issued by a Regulatory Authority in a jurisdiction to register the Product and required for Commercialization in such jurisdiction, but excluding any pricing or reimbursement approval.
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Examples of Market Authorization in a sentence

  • Subject to the terms and conditions set forth in this Agreement, Licensor shall have the sole right and obligation to Manufacture and supply the Imported Products for the Territory, and shall act as the Market Authorization holder for the Imported Products and, with assistance from Licensee, comply with Applicable Laws including without limitation the Regulations on Supervision and Administration of Medical Devices (“Importation Paradigm”).

  • Under Importation Paradigm and before the obtaining of Market Authorization in the Territory, Licensor shall make sure that the Supply Price (including the Imported Product, prototypes, and components, in each case limited to that which is required to be used for Regulatory Approval and Market Authorization purposes) shall be based on the actual production cost prices, with no commercial mark-up.

  • After obtaining Market Authorization in the Territory, the Supply Price shall be based on the actual production cost prices with a fixed markup of [***]% (see Exhibit C).


More Definitions of Market Authorization

Market Authorization means any approved Marketing Application promulgated by Regulatory Authorities.
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Market Authorization means the valid documented approval by the Registration Authority in each of the Countries, or groups of Countries where applicable, within the Territories permitting Kuhnil to commence selling, marketing and distribution of the Products.
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Market Authorization means appropriate authorization for commercialization of the Products received from the relevant regulatory body.
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Market Authorization means registration of a veterinary medicine by the Council and the issuance of a registration certificate under regulation 23;
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Market Authorization means the valid documented approval by the Registration Authority in each Country within the Territory permitting OA to commence selling, marketing and distributing the Product
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Market Authorization means the valid documented approval by the Registration Authority in each Country within the Territory permitting SOI to market, sell and distribute the Product. April 16th, 2007 2 VGN & SOI Portions of this document marked [ * ] are the subject of a request for confidential treatment filed with the Securities and Exchange Commission along with an unredacted version of this Agreement.
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Related to Market Authorization

  • Product Authorizations means any and all approvals, licenses, notifications, registrations or authorizations of any Governmental Authority for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or commercialization of a Product in any country or jurisdiction, including, without limitation, registration and listing, INDs, NDAs and similar applications.

  • Sell Authorization means that Partner needs to meet specific training and qualification requirements for the products included in an “On Premise” Product Family that Partner wants to resell as set out in detail in the PartnerEdge Program Guide and the applicable RSPI.

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

  • 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).

  • Prior authorization means that we must approve the Services in advance in order for the Services to be covered.

  • 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.

  • Necessary Authorizations means all approvals and licenses from, and all filings and registrations with, any governmental or other regulatory authority, including, without limiting the foregoing, the Licenses and all approvals, licenses, filings and registrations under the Communications Act, necessary in order to enable the Borrower and its Subsidiaries to own, construct, maintain, and operate communications tower facilities and to invest in other Persons who own, construct, maintain, manage and operate communications tower facilities.

  • Governmental Authorization means any permit, license, authorization, plan, directive, consent order or consent decree of or from any Governmental Authority.

  • Environmental Authorizations means all licenses, permits, orders, approvals, notices, registrations or other legal prerequisites for conducting the business of the Borrower required by any Environmental Requirement.

  • Service Authorization means that Open Ecosystem Partner needs to meet specific qualification requirements for the products included in a “Service” Product Family that Open Ecosystem Partner wants to promote and offer Services for as set out in detail in the Open Ecosystem Program Guide.

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

  • Applicable Insurance Regulatory Authority means, when used with respect to any Insurance Subsidiary, the insurance department or similar administrative authority or agency located in (x) the state or other jurisdiction in which such Insurance Subsidiary is domiciled or (y) to the extent asserting regulatory jurisdiction over such Insurance Subsidiary, the insurance department, authority or agency in each state or other jurisdiction in which such Insurance Subsidiary is licensed, and shall include any Federal insurance regulatory department, authority or agency that may be created in the future and that asserts regulatory jurisdiction over such Insurance Subsidiary.

  • ACH Authorization means the ACH Debit Authorization Agreement in substantially the form of Exhibit H.

  • Governmental Authorizations means any approval, consent, license, permit, waiver, or other authorization issued, granted, given, or otherwise made available by or under the authority of any Governmental Entity or pursuant to any Legal Requirement.

  • 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.

  • Authorizations means all licenses, permits and approvals required by any governmental or quasi-governmental agency, body or officer for the ownership, operation and use of the Property or any part thereof.

  • Consents, Clearances and Permits means all authorizations, licenses, approvals, registrations, permits, waivers, privileges, acknowledgements, agreements, or concessions required to be obtained from or provided by any concerned authority for the purpose of setting up of the generation facilities and/or supply of power;

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • 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.