definiens: means any approval ( including any supplement, ame ndment, amendment, or pre- and post - approval ), license, registration, or authoriza tion of any national, regional, state, or local reg ulatory authority, department, bureau, commission, council or other Go vernmental Authority, that is necessary for the Commercialization of a pharmaceutical product in a country or regulatory jurisdiction ( including, wher e required, approval of any application for pricing or reimburs ement for such pharmaceutical product by any regula tory authority ) . [ See License Agreement Section 1.120 ] means regulatory applications, filings, submissio ns, notifications, registrations, Regulatory Approvals, or other submissions, includi ng any written correspondence or meeting minutes, m ade to, made with, or received from any Regulatory Authorit y, submitted to a Regulatory Authority ( including a ll INDs, NDAs, and associated common technical documents ) an d any amendments and supplements thereto, and all d ata and other information contained in, and Regulatory Authority correspondence relating to, any of the fo regoing