Room Temperature Formulation Sample Clauses

Room Temperature Formulation. 3.2.3.1. NexMed shall provide Warner with reasonably detailed summaries of all Pre-Notification Room Temperature Formulation Development Activities at such times as Warner shall reasonably request. 3.2.3.2. In the event Warner determines, in its sole discretion, to proceed with the Development and commercialization of the Room Temperature Formulation, Warner shall notify NexMed in writing (such notice, the “Room Temperature Formulation Development Notice”) on or prior to the date that is 30 days following Approval of the Refrigerated Formulation NDA (such date, the “Room Temperature Formulation Notification Date”). Thereafter, the Parties shall promptly enter into good faith discussions in order to determine mutually acceptable product labeling with respect to the Room Temperature Formulation NDA. Following receipt of the Room Temperature Formulation Development Notice, NexMed shall provide Warner with reasonably detailed documentation of all expenses incurred by NexMed relating to Pre-Notification Room Temperature Formulation Development Activities and Warner shall promptly reimburse NexMed for all costs and expenses relating to such Development, including any amounts paid to a contract research organization engaged by NexMed to perform such Development. Following receipt of the Room Temperature Formulation Development Notice (i) all Development thereafter conducted with respect to the Room Temperature Formulation shall be conducted by NexMed at the direction of the JSC in accordance with Section 3.2 and Warner shall reimburse NexMed for (A) all costs and expenses relating to such Development, including any amounts paid to a contract research organization engaged by NexMed to perform such Development and (B) any filing fees paid to the FDA with respect to the Room Temperature Formulation NDA and (ii) at the direction of the JSC in accordance with Section 3.2, NexMed will use commercially reasonable efforts to prepare, submit and obtain Approval of a Room Temperature Formulation NDA that reflects the labeling agreed by the Parties, as promptly as practicable. For the avoidance of doubt, it is understood that Warner shall only be responsible to reimburse NexMed for Pre-Notification Room Temperature Formulation Development Activities if Warner delivers the Room Temperature Formulation Development Notice and in no instance shall Warner be responsible to reimburse NexMed for Development conducted prior to the Effective Date. The Party manufacturing the Room Te...
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