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 all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of the Product in such country.
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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.
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Examples of Marketing Approval in a sentence

  • NK shall send the first such report within [**Redacted**] calendar days of receiving the first Marketing Approval in the Territory which will include Net Sales for the next [**Redacted**] Calendar Quarters.

  • Innovent, either directly or through its Affiliates shall use Commercially Reasonable Efforts to launch the Product(s) in the Field as soon as reasonably practicable after receipt of the Marketing Approval therefor in each of the regions within the Territory, and thereafter to market, promote and sell Product(s) in the Field in such regions.

  • NK or its local agent shall hold and own all Regulatory Filings including the Marketing Approval in the Territory as MAH in the Territory.

  • NK or its local agent shall be responsible for seeking, obtaining, and maintaining Marketing Approval (and required registration of Japanese Accepted Names for Pharmaceuticals (JAN)) and pricing and reimbursement approvals for all Licensed Products in the Territory, at NK’s sole cost and expense (including such costs and expenses associated with approval of New Indications of the Licensed Product(s)).

  • Innovent shall send the first such report within [**Redacted**] calendar days of receiving the first Marketing Approval anywhere in the Territory, provided that such first report need only include a non-binding forecast (i.e., no royalty payment will be due) of Net Sales for the next [**Redacted**] quarters.


More Definitions of Marketing Approval

Marketing Approval means, as applicable, the approval of an NDA by the FDA in the United States or approval of a comparable application by a Regulatory Authority in any other country or jurisdiction for the manufacture, supply, marketing and sale of a pharmaceutical product. For clarity, “Marketing Approval” shall not include any governmental pricing and/or reimbursement approvals and/or authorizations issued by a Regulatory Authority or any other governmental agency in any country or jurisdiction.
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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.
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Marketing Approval means the act of a Regulatory Authority necessary for the marketing and sale of the Product in a country or regulatory jurisdiction, including, without limitation, the approval of the NDA by the FDA, EC Approval, and Japanese Approval.
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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.
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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;
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Marketing Approval means, with respect to a Product in a particular jurisdiction, all approvals (including regular or accelerated approval of a BLA or NDA), licenses, registrations or authorizations necessary for the Commercialization of such Product in such jurisdiction, including, with respect to the United States, approval of an Approval Application for such Product by the FDA and with respect to Europe, approval of an Approval Application for such Product by the European Commission or the applicable Regulatory Authority in any particular country in Europe.
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Marketing Approval means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport and sale, and in Europe, payor approval of price and reimbursement for Licensed Product. of Licensed Products in a regulatory jurisdiction. “Marketing Approval” shall be deemed to occur upon first receipt of notice from a Regulatory Authority that sale of a Licensed Product has been approved.
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