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 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.

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.

Examples of Marketing Approval in a sentence

• Notwithstanding the foregoing, on and after the Option Exercise Date, Xxxxxxx shall not publish any results relating to a TARP8 Compound or TARP8 Product without the prior written consent of Licensee, provided, however, that Xxxxxxx may publish on the results of on-label studies with a TARP8 Product that has received Marketing Approval.

• If the Additional Study Data is later included in the label of a CoDev Product that has received Marketing Approval anywhere in the world (whether or not such Marketing Approval is for the Non-Proposing Party’s respective Territory), the Non-Proposing Party shall reimburse the Proposing Party for [***] percent ([***]%) of the Development Costs associated with such Unsponsored Work, such amount to be deducted from any amounts owed to the Non-Proposing Party under Section 4(b) of Exhibit 1.189.

• The Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”) at an appropriate time, reasonably in advance of the first potential Marketing Approval of a CoDev Product and reasonably in advance of the time required for the Global Commercialization Strategy to be prepared as set forth in Section 6.1.

• The initial SGEN Territory Commercialization Plan will outline plans for establishing, training and qualifying the appropriate number of sales representatives and medical science liaisons prior to applicable Marketing Approval.

• AnHeart, either directly or through its Affiliates, and/or its Sublicensees, shall use Commercially Reasonable Efforts to launch Product(s) in the Territory in the Field as soon as reasonably practicable after receipt of the Marketing Approval in a country where such Marketing Approval was obtained, and thereafter to market, promote and sell Product(s) in the Territory in the Field in such country.

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.

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 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.

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 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 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.

Marketing Approval means, with respect to a Product in a particular jurisdiction, all approvals, licenses, registrations or authorizations necessary for the Commercialization of such Product in such jurisdiction, including only where mandatory for Commercialization of such Product, approval of labeling, price, reimbursement and manufacturing.