Regulatory Approval

Regulatory Approval. The authorizations and approvals of any Regulatory Authority (including, without limitation, approvals of ANDAs and NDAs) required for the commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of Product(s) in the Territory.

Regulatory Approval. The approval of the applicable Regulatory Authority necessary for the marketing and sale of Product in the Territory

Regulatory Approval. Means all consents, permits, approvals, licenses, authorizations, qualifications, notices or orders that are issued or granted by Regulatory Authorities which are required for the manufacture, marketing, promotion, pricing and sale of the Product in a country within the Territory.

Regulatory Approval. All official approvals by government, pricing or health authorities in a country (or supra-national organizations, such as the EMEA) which are required for first sale, including, importation or manufacture of a PRODUCT in such country where required.

Regulatory Approval. The procurement of the registrations, permits and approvals (including accelerated and/or full approval), including the NDA or other submission required by applicable government Regulatory Authorities for the Manufacture, import, marketing, sale and distribution of a Product

Regulatory Approval. Means, with respect to a Licensed Product, any and all approvals, licenses, registrations or authorizations necessary for the sale and marketing of the Licensed Product throughout the Territory.

Regulatory Approval. Final Marketing approval by the FDA for the sale and Marketing of a pharmaceutical product in the Territory

Regulatory Approval. Means any approved New Drug Application, Supplemental New Drug Application (as such application types are defined in the United States Federal Food, Drug and Cosmetic Act or applicable regulations promulgated thereunder), and all other government or regulatory approvals (including, without limitation, where applicable, pricing and reimbursement approval and schedule classifications), product and/or manufacturing facility licenses, conformity assessments, registrations or authorizations.

Regulatory Approval. Any and all Governmental Authorizations (including price and reimbursement approvals) that are necessary for the manufacture, use, storage, import, transport, and/or sale of a product in such jurisdiction. In the United States, Regulatory Approval shall be deemed to occur upon clearance by the FDA for marketing for the sought after indications

Regulatory Approval. Means all approvals, including Pricing Approvals and government reimbursement approval (in each case if applicable), necessary for the commercial sale of a Product in a given country or regulatory jurisdiction