Right to Opt Back In Prior to Phase III Sample Clauses

Right to Opt Back In Prior to Phase III. The Non- Participating Phase IIb Party for a Product Candidate under a Unilateral Phase IIb Plan shall have the right to opt back in to the Development of such Product Candidate (the “Pre-Phase III Opt-In”) by providing the Participating Phase IIb Party with written notice of its exercise of such Pre-Phase III Opt-In (the “Pre-Phase III Election Notice”) within [***] days after receiving from the Participating Phase IIb Party: (A) a Completion Notice with respect to such Unilateral Phase IIb Development, (B) reasonable access to (with the ability to analyze and manipulate but not change) the electronic database that contains the Regulatory Data with respect to such Unilateral Phase IIb Development, and (C) a written statement of the costs that would need to be paid under clauses (1), (2) and (3) below by the Non-Participating Phase IIb Party if it elects to exercise its Pre-Phase III Opt-In ((A), (B) and (C) collectively, the “Pre- Phase III Notification”). In addition, the Participating Phase IIb Party promptly shall provide to the Non-Participating Phase IIb Party such additional Information and Regulatory Documentation with respect to the Development activities described in such Completion Notice as may be reasonably requested by the Non-Participating Phase IIb Party in order to evaluate such Development activities. The Participating Phase IIb Party shall provide the Pre- Phase III Notification to the Non-Participating Phase IIb Party promptly after completion of such Unilateral Phase IIb Development. Any Pre-Phase III Opt-In exercise shall become effective only if the Non-Participating Phase IIb Party pays the Participating Phase IIb Party an amount equal to the sum of the following (as applicable) within [***] days after its delivery of the Pre-Phase III Election Notice: (1) [***] percent ([***]%) of the Participating Phase IIb Party’s Development Costs incurred in connection with such Unilateral Phase IIb Plan (even if such Non-Participating Phase IIb Party delivers its notice of election to opt back in prior to the completion of such activities); and (2) if such Non-Participating Phase IIb Party also has been a Non-Participating Pre-Phase IIb Party during any Unilateral Pre-Phase IIb Development for the applicable Product Candidate, [***] percent ([***]%) of the Participating Pre- Phase IIb Party’s Development Costs incurred in connection with such Unilateral Pre-Phase IIb Party’s Development; and (3) if such Non-Participating Phase IIb Party also h...
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