Regulatory Approval

Example Definitions of "Regulatory Approval"
Regulatory Approval. Shall mean any approvals (including supplements, amendments, pre- and post¬ómarketing approvals, and pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture, distribution, use or sale of Products containing the Materials in a... regulatory jurisdiction View More
Regulatory Approval. Shall mean any Any approvals (including supplements, amendments, pre- pre-marketing and post¬ómarketing post-marketing approvals, and pricing and reimbursement approvals), licenses, registrations or authorizations of any national, national (e.g., the FDA), supra-national (e.g., the European Commission or the Council of the European Union), EMEA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture,... distribution, use or sale of Products containing the Materials Product in a regulatory jurisdiction jurisdiction. View More
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Regulatory Approval. Any and all approvals (including price and reimbursement approvals), licenses, registrations, or authorizations of the United States or European Union or any country, federal, state or local regulatory agency, department, bureau or other government entity that is necessary for the manufacture, use, storage, import, transport and/or sale of a product in a given jurisdiction.
Regulatory Approval. Any and all approvals (including price and reimbursement approvals), approvals, as applicable), licenses, registrations, or authorizations of the United States or European Union or any country, federal, state or local regulatory agency, department, bureau or other government entity that is are necessary for the manufacture, use, storage, import, transport and/or and sale of a product the Targacept Product in a given jurisdiction. particular jurisdiction
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Regulatory Approval. Means, with respect to the Product, any approval (notwithstanding the indication), registration, license or authorization from the FDA to market and sell such Product in the Territory.
Regulatory Approval. Means, with respect to the Product, any NDA approval (notwithstanding the indication), registration, license or authorization from the FDA to market and sell such Product in the Territory. Territory in the Field.
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Regulatory Approval. In a particular country means all approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations, and authorizations of any federal, national, multinational, state, provincial or local Regulatory Authority, department, bureau and other governmental entity that are necessary for the marketing and sale of a Licensed Product in a country.
Regulatory Approval. In a particular country means all All approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations, and authorizations of any federal, national, multinational, state, provincial or local Regulatory Authority, department, bureau and or other governmental entity that are necessary and sufficient for the marketing and sale of a Licensed Product product in a country. country or group of countries. Regulatory Approval includes any required pricing and... reimbursement approval for the Product. View More
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Regulatory Approval. Means any approvals (including price reimbursement approvals) and any master files, DMFs, establishment licenses, registrations or authorizations of any national or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacture, use, storage, importation, export, transport, distribution or sale of a Product in the Field (including the approval of an MAA).
Regulatory Approval. The regulatory approval that Tenant is required to obtain from all applicable Federal and State of Maryland regulatory bodies in order to operate a branch bank office at the Property.
Regulatory Approval. All governmental approvals and authorizations necessary for the manufacture and commercial sale of the Product in a country of the Territory, including, but not limited to, marketing authorization, pricing approval and pricing reimbursement, as applicable
Regulatory Approval. Means any approvals, product and/or establishment licenses, BLAs, BLA equivalents, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the commercial manufacture, use, storage, import, export, transport, marketing or sale of the Product in a regulatory jurisdiction.
Regulatory Approval. Means any approval, license, registration or authorization from a Governmental Agency necessary for the manufacture, use, storage, import, transport or sale of the Product in the Territory.
Regulatory Approval. Means the procurement of the registrations, permits and approvals required by applicable government authorities for the manufacture, importation into, marketing, sale and distribution of the Drug Substance or the Drug Product in the Territory, including, without limitation, the DMF and the ANDA.
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