definiens: shall mean the technical, medical and scienti;fi~ licenses, registrations, authorizations and approvals ( including~ without limitation, approvals of Investigational Drug Applications, New Drug Applications and equivalents, supplements and amendments, pre · and post - approvals . pricing and third party reimbursement approvals, and labeling approvals ) of any national, supra - national, regional, state or local regulatory agency > department, bureau, commission, councilor other governmental entity, necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Collaboration Produpt{s ) in a regnlatory jurisdiction · 1.55 shall mean, collectively, InveStigational New Drug Applications, Product License Applications, Drug MliSter Files, NDAs andlor any other equivalent or comparable filings as may be required by Regulatory Authorities to obtain Regulatory Approvals