Critical Junctures; Critical Criteria Sample Clauses

Critical Junctures; Critical Criteria. The Development Plan for each Product shall provide for various “critical junctures”, at different points along the development timeline (e.g., the completion of Phase II Clinical Trials) (each a “Critical Juncture”). The JSC shall establish, with respect to each Critical Juncture, (a) one or more objective criteria, all of which a reasonable, similarly-situated pharmaceutical company would reasonably require to be satisfied at such Critical Juncture before continuing with the development of such Product (assuming that such company were solely funding such development) (with respect to any given Critical Juncture, all of the relevant such criteria being referred to, collectively, as the “Critical Criteria”) and (b) a precise date or other reasonably-defined time (e.g., “on or before the date falling thirty (30) days after the completion of Phase II Clinicals”) by which a Party wishing to exercise its opt-out rights under Section 5.11.3 must give notice thereof to the other Party (the “Opt-Out Notice Date”).
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Related to Critical Junctures; Critical Criteria

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  • Technical Objections to Grievances It is the intent of both Parties of this Agreement that no grievance shall be defeated merely because of a technical error, other than time limitations in processing the grievance through the grievance procedure. To this end, an arbitration board shall have the power to allow all necessary amendments to the grievance and the power to waive formal procedural irregularities in the processing of a grievance, in order to determine the real matter in dispute and to render a decision according to equitable principles and the justice of the case.

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