Marketing Approval definition

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.

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Marketing Approval means, with respect to a Licensed Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the Commercialization of such Licensed Product in such jurisdiction, including, with respect to the United States, approval of an Approval Application for such Licensed Product by the FDA and with respect to the European Union, approval of an Approval Application for such Licensed Product by the European Commission.

Marketing Approval means all approvals from the relevant Regulatory Authority in a given country necessary to market and sell a pharmaceutical product in such country, including pricing and reimbursement approvals if required for marketing or sale of such product in such country.

Examples of Marketing Approval in a sentence

A Joint Steering Committee (the “JSC”) shall be formed to oversee the overall activities of the Parties in the Development, seeking Marketing Approval, and Commercialization of the Licensed Product in the Territory.
NS shall report to the JSC in writing, by no later than each [***] following the first Marketing Approval of the Licensed Product in the Licensed Field in the Territory (for the period ending [***] of the prior NS Fiscal Year), summarizing NS´s Commercialization activities for the Licensed Product in the Territory performed to date (or updating such report for activities performed since the last such report was given hereunder, as applicable) and activities to be undertaken in the next NS Fiscal Year.
During the term of this Agreement, Vicore grants to NS the license to use Vicore Trademark to Research and Develop, seek Marketing Approval with respect to, and Commercialize the Licensed Product in the Territory.
The JSC shall be responsible for discussing, approving and monitoring the execution of the Development Plan, seeking Marketing Approval, and Commercialization of the Licensed Product in the Territory.
NS shall use Commercially Reasonable Efforts to obtain Marketing Approval as well as Orphan Drug Designation for the Licensed Product in the Initial Indication and [***], as well as any Additional Indications (if and when such Additional Indications are added to the Licensed Field) in the Territory on the timelines included in the Development Plan, including conducting all Development and regulatory activities needed to obtain such approvals.

More Definitions of Marketing Approval

Marketing Approval means, with respect to each country, approval by the FDA or the applicable health regulatory authority in or for such country that is the counterpart of the FDA of the applicable MAA for Product filed in or for such country.

Marketing Approval means final approval of an NDA by the FDA, or final approval of a comparable document filed with an equivalent health regulatory authority in any other country or in the European Union (using the centralized process or mutual recognition), including all required marketing, pricing or reimbursement approvals.

Marketing Approval means all approvals (including NDA Approvals and, where available under Applicable Law, pricing and reimbursement approvals in accordance with Applicable Law) of any Regulatory Authority in the Territory, that are necessary or useful to be obtained prior to the manufacture or Commercialization of a Product in the Territory. For purposes of clarification, “Marketing Approval” in the U.S. shall have the same meaning as NDA Approval in the U.S.

Marketing Approval or “MA” means those Regulatory Approval(s) required by applicable laws and regulations in a particular country or territory in order to sell or commercially supply a medicinal product and/or device in that country or territory;

Marketing Approval means approval of a Drug Approval Application by the applicable Regulatory Authority.

Marketing Approval means, within any given country, approval to market a Product legally as a drug or biologic, including approval of a Biologic License Application (as defined in the U.S. Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder (21 C.F.R. §§ 600-680) in the United States, or approval of a comparable filing in the United States or any other jurisdiction. Pricing approval need not be obtained in order for Marketing Approval to be achieved.

Marketing Approval means an NDA approved by the FDA, a marketing authorization application approved by the EMA under the centralized European procedure, or any corresponding non-U.S. or non-EMA application, registration or certification, necessary or reasonably useful to market a Licensed Product approved by the corresponding Regulatory Authority, including pricing and reimbursement approvals where required.