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.
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
If the Seller or Holdings receives U.S. Marketing Approval with one or more Unexpected Contraindications, then the Buyer Representative (if more than one Buyer, on behalf of all Buyers) may terminate this Agreement by delivering written notice to the Seller of such election.
TERMINATION 35 Section 9.1 Mutual Termination 35 Section 9.2 Termination upon Failure to Achieve U.S. Marketing Approval 35 Section 9.3 Buyer Termination for Unexpected Contraindications 35 Section 9.4 Automatic Termination 35 Section 9.5 Survival 35 ARTICLE 10.
This Agreement shall automatically terminate upon Seller’s or Holdings’ failure to achieve U.S. Marketing Approval by the Marketing Approval Deadline unless such date is extended by the mutual written agreement of the Seller and the Buyer.
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, with respect to the Product in a jurisdiction, approval from the relevant Regulatory Agency to commence marketing and sales of the Product in such jurisdiction, including, without limitation, 510(k) clearance in the United States from the FDA.
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 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.
Marketing Approval means approval of a Drug Approval Application by the applicable Regulatory Authority.