Marketing Approval definition
Marketing Approval means any approval, including price approval, registration, license or authorization from any Regulatory Authority required to market and sell a Licensed Product in a jurisdiction and shall include an approval, registration, license or authorization granted in connection with an NDA.
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 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 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 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, with respect to each country of the Territory for a particular Product, approval of the applicable MAA filed in such country by the health regulatory authority in such country that is the counterpart of the FDA. It is understood that Marketing Approval does not necessarily include pricing or reimbursement approval.
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 Product approved by the corresponding Regulatory Authority, including pricing and reimbursement approvals where required. For clarity, notwithstanding the foregoing, solely with respect to Section 6.2, “Marketing Approval” shall not include pricing and reimbursement approvals.
Marketing Approval means approval of a Drug Approval Application by the applicable Regulatory Authority.