Regulatory Approval definition

Regulatory Approval means, with respect to the Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization that is required by the applicable Regulatory Authority to market and sell the Product in such country or jurisdiction.

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Regulatory Approval means any and all approvals, licenses, registrations, or authorizations of the relevant Regulatory Authority, including Price Approvals, necessary for the Development, manufacture, use, storage, import, transport or Commercialization of Product in a particular country or jurisdiction.

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 all approvals (including pricing and reimbursement approvals required for marketing authorization), product and/or establishment licenses, registrations or authorizations of all regional, federal, state or local regulatory agencies, departments, bureaus or other governmental entities, necessary for the manufacture, use, storage, import, export, transport and sale of Product in a regulatory jurisdiction.

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

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.

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.