In and Notice Sample Clauses

In and Notice. Subject to Section 5.6(e)(ii) below, for any particular Unilateral Product in a Royalty Region, a Party that has been the Non- Participating Phase III Party under the Unilateral Phase III Plan shall have the right to convert such Unilateral Product to a Joint Product in such Development Region after the completion of the first Phase III Clinical Study for such Unilateral Product (the “EOP3 Opt-In”) by providing the Participating Phase III Party with written notice of its exercise of such EOP3 Opt-In (the “EOP3 Election Notice”) within [***] days after receiving from the Participating Phase III Party: (A) a Completion Notice with respect to such Phase III Clinical Study, (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 Phase III Clinical Study and all other Development activities under the applicable Unilateral Phase III Plan, and (C) a written statement of the costs that would need to be paid under Section 5.6(e)(iii) below by the Non-Participating Phase III Party if it elects to exercise its EOP3 Opt-In incurred by the Participating Phase III Party through the last day of the Calendar Quarter immediately preceding the Calendar Quarter in which such statement is provided (such date, the “Statement Cut-Off Date”) ((A), (B) and (C) collectively, the “EOP3 Notification”). In addition, the Participating Phase III Party promptly shall provide to the Non-Participating Phase III 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 III Party in order to evaluate such Development activities. The Participating Phase III Party shall provide the EOP3 Notification to the Non-Participating Phase III Party promptly after completion of such first Phase III Clinical Study.
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Related to In and Notice

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