Day One Responsibilities Clause Samples

Day One Responsibilities. Subject to Applicable Law and this Section 4.8(b), Day One will, at its sole expense, oversee, monitor, and manage all regulatory interactions, communications, and filings with, and submissions to, Regulatory Authorities with respect to the Products and the Compound in the Day One Field in the Territory; provided that Day One will provide Takeda with a copy of all proposed material Regulatory Submissions filed with or submitted to any Regulatory Authority for Takeda’s review and comment sufficiently in advance of Day One’s filing or submission thereof, and Day One will reasonably consider in good faith incorporating comments received from Takeda into such Regulatory Submissions, subject to Section 9.4. Subject to Section 4.11, Day One will have final decision making authority regarding all regulatory activities, including the Labeling strategy and the content of submissions with respect to the Compound and all Products, subject to the terms and conditions of this Agreement, other than the Takeda Products and the Compound for the use in the Manufacture of Takeda Products in the Takeda Field.