Unilateral Activities Sample Clauses
The Unilateral Activities clause defines the rights and limitations of one party to undertake certain actions independently, without requiring the consent or involvement of the other party. Typically, this clause outlines specific activities—such as making decisions, entering into agreements, or performing tasks—that one party may carry out on its own, and may set boundaries to prevent overreach or conflicts of interest. Its core practical function is to streamline operations and clarify authority, reducing delays and disputes by specifying when and how a party can act unilaterally.
Unilateral Activities. (a) With respect to any Clinical Study or Post Approval Study that satisfies the criteria set forth in Section 2.5.1, if either Party (the “Opting-Out Party”), pursuant to the terms of Section 2.6, opts-out (each, an “Opt-Out”) of: (a) any modification of a (i) Clinical Study or (ii) a Post Approval Study, in each case ((i) and (ii)) already initiated and ongoing under the Development Plan; or (b) initiation of (i) a Clinical Study (including a Registrational Study), or (ii) a Post Approval Study, in each case ((i) and (ii)) for any part of the Territory, the Party (the “Developing Party”) desiring to proceed with such activities (“Proposed Unilateral Activities”) shall prepare and provide to the JDC a proposed development plan and budget with respect thereto. Such proposed development plan and budget shall in each case be in a format and with such detail corresponding to the Development Plan in effect at such time. If the JDC determines or it is otherwise determined that any such Proposed Unilateral Activities comply and are otherwise consistent with Section 2.5.3, then such activities shall be deemed to be “Unilateral Activities” hereunder, and the Developing Party shall have the right to proceed with such Unilateral Activities in accordance with the terms and conditions of this Agreement.
(b) Notwithstanding the foregoing, either Party may propose to the JDC as a Unilateral Activity a Clinical Study or Post Approval Study that is scientifically reasonable but does not satisfy the requirements of Section 2.5.1. In such event, the Parties may agree to incorporate such Clinical Study in the Development Plan as a joint activity hereunder or the proposing Party may conduct such Clinical Study or Post Approval Study as a Unilateral Activity. For purposes of this Agreement, the Party that is conducting such Unilateral Activity shall be deemed the Developing Party with respect to such Unilateral Activity and the other Party shall be deemed to be the Opting-Out Party with respect to such Unilateral Activity following confirmation from the other Party that it did not wish to Opt-In.