Common use of Regulatory Application Clause in Contracts

Regulatory Application. Regulatory Application" shall mean any application or request necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Product, including but not limited to, any applications or requests for: (i) approval of Product, including any NDAs, and supplements and amendments thereto; (ii) pre- and post-approval marketing authorizations (including any applications for prerequisite manufacturing approval or authorization related thereto); (iii) labeling approval; (iv) technical, medical and scientific licenses; and (v) registrations or authorizations from any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Product.