definiens: or means the initial plan outlining the Parties ’ intended program to DevelopProduct Candidates or Products in North America and the Territory, including a general description of all relatedactivities therefor, all as reflected in the Global Development Plan, with associated budgets, discussed by theParties immediately prior to the Effective Date and to which the Parties have agreed . The Parties havedesigned the Global Development Plan to support certain anticipated Product indications and label claims andrelated necessary label information ( the ), and the Development activities listed in the GlobalDevelopment Plan are considered critical to obtaining Regulatory Approval in both the United States and the EUfor the Desired Label . Other Development activities that are critical to obtaining Regulatory Approval for theDesired Label in the United States or the EU, or that are required by a Regulatory Authority in either the UnitedStates or the EU for the Desired Label, may be added to the Global Development Plan from time to time byamendment as provided herein . Development activities that are not critical to obtaining Regulatory Approval inthe United States or the EU for the Desired Label shall be considered Additional Development Activities, unlessthe Parties mutually agree to include such activities in the Global Development Plan . The Global DevelopmentPlan as amended from time to time in accordance with the terms of this Agreement shall constitute, as soamended, the Global Development Plan