definiens: shall mean any application or request necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export, sale, reimbursement or pricing of a CollaborationProduct, including but not limited to any applications or requests for ( i ) approval of Collaboration Product, including NDAsand MAAs, abbreviated new drug applications or supplemental new drug applications or any supplements or amendmentsthereto ( as defined in 21 C.F.R. § 314.50 et . seq . ) submitted to the FDA or foreign equivalent ; ( ii ) pre- and post - approvalmarketing 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 localregulatory 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 Collaboration Product