Regulatory Approval definition

Regulatory Approval means any applicable approvals of any Governmental Authorities, including without limitation, where applicable, Marketing Authorization, schedule classifications, permits, licenses, registration, necessary and relevant to market, distribute, promote and commercialize Product in the Territory.

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Regulatory Approval means any and all approvals, marketing authorizations, registrations and licenses (including amendments and supplements thereto) necessary from a Governmental Authority for the Commercialization or manufacture of the Licensed Products in or for the Territory.

Regulatory Approval means any and all approvals (including price and reimbursement approvals, if required), licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a Product in such jurisdiction.

Examples of Regulatory Approval in a sentence

Neurocrine’s diligence obligations under this Agreement with respect to the Development and Commercialization of Products shall be deemed satisfied (without limitation) so long as Neurocrine, its Affiliates and/or sublicensees obtain and maintain Regulatory Approval in the Exclusivity Field for at least one Product and Commercialize such Product in each of the Major Markets.
Updates of such Development Plan will be provided to Sanofi in accordance to Section 3.4 and will set specific objectives and timelines for carrying out development activities to progress the development towards Regulatory Approval of each Sanofi Product that ▇▇▇▇▇▇▇▇▇▇ has elected to develop hereunder.
At least annually by the end of the first Calendar Quarter of each Calendar Year until Regulatory Approval is obtained for a Product in at least one Major Market, Neurocrine shall provide Sanofi with a summary report describing the Development activities it has performed, or caused to be performed, during the preceding Calendar Year and the Development activities it intends to have conducted during the then current Calendar Year together with an updated Development Plan for the Products.

More Definitions of Regulatory Approval

Regulatory Approval means the technical, medical and scientific licenses, registrations, authorizations and approvals (including approvals of Approval Applications, supplements and amendments, pre- and post- approvals, and labeling approvals) of any Regulatory Authority, necessary for the Research, Development, clinical testing, commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of a pharmaceutical product in a regulatory jurisdiction, including Marketing Approval.

Regulatory Approval means, with respect to a product, all approvals, licenses, registrations or authorizations necessary to market and sell such product in a particular jurisdiction in the Territory (including applicable approvals of labeling, price and reimbursement for such product in such jurisdiction).

Regulatory Approval means, with respect to a country in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market a Licensed Product in such country, including, where applicable, (i) pricing or reimbursement approval in such country, (ii) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto) and (iii) labeling approval.

Regulatory Approval means any authorization, approval, license, registration, or permit required or issued by any Regulatory Agency.

Regulatory Approval means, with respect to a product in a country, the approval of the applicable Regulatory Authority necessary for the marketing and sale of such product in such country.

Regulatory Approval means all approvals by the applicable regulatory agency in the relevant country of the Territory necessary to market and sell a Licensed Product.

Regulatory Approval means with respect to a country, extra-national territory, province, state, or other regulatory jurisdiction, any and all approvals, licenses, registrations or authorizations of any Regulatory Authority necessary in order to commercially distribute, sell, manufacture, import, export or market a product in such country, state, province, or some or all of such extra-national territory or regulatory jurisdiction, but which shall exclude any pricing and reimbursement approvals.