Regulatory Approval

Regulatory Approval. Shall mean any approvals (including supplements, amendments, pre- and post—marketing 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. 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. 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. 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. 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.