Regulatory Approval

Regulatory Approval. With respect to a country or other jurisdiction, all approvals, licenses, clearances, marks, registrations, authorizations certificates, exemptions, consents, franchises, concessions, notices or other like item of or issued by any Regulatory Authority, from the relevant Governmental Authority necessary or useful to commercially distribute, sell or market a product in such country or other applicable jurisdiction (not including any applicable pricing and governmental reimbursement approvals... unless legally required to market the product in a country or other applicable jurisdiction) View More

Regulatory Approval. 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 all authorizations, approvals, licenses, and registrations issued by or otherwise required from the appropriate Regulatory Authority necessary for the Production, distribution, use or commercial sale in a jurisdiction.

Regulatory Approval. Means, with respect to a particular country or regulatory jurisdiction, any and all approvals, clearances or other authorizations to develop, test, use, make, transport, store or commercialize a particular product or service in such country or regulatory jurisdiction, including all amendments and supplements thereto.

Regulatory Approval. Means, with respect to a Product in the Territory, any approval, registration, license, or authorization from the FDA or any other Regulatory Authority in the Territory that is necessary to market and sell such Product in the Territory.