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

The Seller has on hand or has made adequate provisions to secure sufficient clinical quantities the Product to complete all clinical trials and all activities required for U.S. Marketing Approval, in each case, that are ongoing or planned as of the date hereof.
A high-level outline of the Development activities currently contemplated by the ICT Group for the Product Candidates in the ICT Territory (including any Non-Clinical Studies and Clinical Trials), including any licensees or subcontractors anticipated to be used in connection therewith, including regulatory plans and other regulatory activities to obtain Marketing Approval for any Product in the ICT Territory, including anticipated timelines, is attached hereto as Schedule 5.2 (the “ICT Development Plan”).
The Seller shall use Commercially Reasonable Efforts to (i) complete clinical development of the Product in the Territory as required for U.S. Marketing Approval, (ii) obtain and maintain the U.S. Marketing Approval, and (iii) obtain and maintain Marketing Approvals for the Product for the Approved Indication in the Territory, and (iv) following Marketing Approval of any Product in the Territory, Commercialize such Product in the Territory.
On or prior to the Marketing Approval Deadline (including any extension thereof), if the Seller receives U.S. Marketing Approval with any BlackBox Warnings or one or more Unexpected Contraindications, then the Buyer may terminate this Agreement immediately by delivering written notice to the Seller of such election.
Lyell has no other obligation to Develop, or seek or obtain Marketing Approval for, any Product Candidate or Product under this Agreement.

More Definitions of Marketing Approval

Marketing Approval means with respect to any Licensed Compound or Licensed Product in any regulatory jurisdiction in the Territory, approval from the applicable Regulatory Authority sufficient for the promotion and sale of such Licensed Compound or Licensed Product in such jurisdiction in accordance with applicable Laws.

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 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 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, in respect of any jurisdiction, the receipt by either of Buyers of all authorizations by the appropriate Governmental Entities necessary for the commercial sale of the Product (including exports) in such jurisdiction, including approval of labeling, price, reimbursement and manufacturing, where required as a legal prerequisite to commercial sale of the Product.

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.