Decision-Making Exceptions Clause Samples

Decision-Making Exceptions. Notwithstanding the foregoing provisions of this Article 3, (i) if a Party reasonably and in good faith believes that there is a material safety issue with respect to a Licensed Product being used in a given Clinical Trial that is being conducted hereunder, then such Party shall have the right to require the other Party to suspend, and such other Party shall suspend as so required, such Clinical Trial (subject to the other Party’s obligation to comply with legal and regulatory requirements) until such safety issue is reasonably resolved, or (ii) if a Party reasonably and in good faith believes that a change to any Research Plan or a Development Plan is required in order for either Party to ensure compliance with Applicable Laws (or to satisfy a specific governmental authority request), then such Party shall notify the other Party thereof in writing, including a reasonably detailed description of such changes and requirements to comply with Applicable Law, and such changes shall thereafter be deemed to an amendment to the then-current plan; provided that the determination as to whether such changes are required to comply with Applicable Law or satisfy a governmental authority request shall be subject to Article 21.