definiens: means that certain regulatory agreement to be ent ered into by the Parties to define the Parties ’ respective roles and responsibi lities related to regulatory strategy, labeling str ategy ( including a delineation of any product label(s ) of a Party th at will be expanded to include the other Party ’s Re gulatory Approvals, in accordance with Section 5.8 ), dossier preparation, interactions with Regulatory Authorit ies, coordination of Regulatory Approval Application sub mission contents, timing and other matters, to enab le each Party to comply with its respective obligations und er Applicable Law, with regard to filings and inter actions with any Regulatory Authority related to [COMPANY] seeking Regulatory Approval of the Licensed Compound as a component of a [COMPANY] Combination Regimen and [COMPANY] seeking Regulatory Approval of the [COMPANY] Pipeline Asset as a component of a Macr oGenics Combination Regimen . 1.126 means any and all approvals ( including supplements, amendments, pre- and post - approvals and pricing and reimbursement approvals, but excluding Manufacturing approvals ), licenses, registrations or authorizations of any national, re gional, state or local Regulatory Authority, depart ment, bureau, commission, council or other governmental entity, t hat are necessary to Commercialize any Compounds or Products under this Agreement in any country or jur isdiction in the Territory, for one or more uses, i ncluding any pricing and reimbursement approvals that are necess ary to conduct a launch of such Compound or Product in such country or jurisdiction ( even if such approvals are not legally required to launch such Compound or Pr oduct in such country or jurisdiction )