Initial Licensed Product Clause Samples

Initial Licensed Product. 3.1.1 POZEN has filed the POZEN NDA in its own name and at its own expense. Subject to the provisions of Section 3.4, prior to approval of the POZEN NDA, POZEN will be solely responsible for any and all communications with the FDA relating to the Initial Licensed Product or the POZEN NDA. 3.1.2 Upon approval by the FDA of the POZEN NDA, POZEN will transfer such approved NDA to Xcel. Following such transfer, Xcel will maintain such NDA during the Term at Xcel’s expense and will (a) obtain and maintain such other Regulatory Approvals as are necessary for the Commercialization of the Initial Licensed Product in the Territory, and (b) exercise Commercially Reasonable Efforts to cause any manufacturers of the Initial Licensed Product (or any components thereof, as applicable) to obtain and maintain such other Regulatory Approvals as are necessary for the manufacture at their respective facilities of the Initial Licensed Product (or any components thereof, as applicable) for commercial sale in the Territory. 3.1.3 POZEN will retain the IND filed by POZEN for the Initial Licensed Product until POZEN has either (a) [CONFIDENTIAL TREATMENT REQUESTED] the SNDA for the Autoinjector Presentation (the “Autoinjector SNDA”) for submission to the FDA pursuant to Section 3.2 and such SNDA is approved by the FDA, or (b) [CONFIDENTIAL TREATMENT REQUESTED] the Autoinjector SNDA and Xcel has [CONFIDENTIAL TREATMENT REQUESTED] the Autoinjector SNDA, which ever occurs first. At such time, POZEN will transfer such IND to Xcel, subject to POZEN’s retained right to have Xcel make filings to such IND on behalf of POZEN, at POZEN’s request and expense, for purposes of further development of Licensed Products by POZEN for use outside the Territory. 3.1.4 If the FDA requires or suggests that additional data or information be submitted by POZEN as a condition to approving the POZEN NDA, POZEN will inform Xcel thereof without delay. Subject to Section 3.1.5 below, [CONFIDENTIAL TREATMENT REQUESTED] will conduct such studies (including any post-approval studies required by the FDA as a condition to approval of the POZEN NDA) as are necessary to satisfy the requests of the FDA, at [CONFIDENTIAL TREATMENT REQUESTED]’s expense.

Initial Licensed Product. XOMA shall notify Servier in writing within [*] Business Days of the first achievement of each of the milestone events in the table below with respect to the Initial Licensed Product, and the corresponding milestone payment shall be due within [*] Business Days of XOMA’s receipt of an invoice therefor from Servier. Upon acceptance by the FDA of the NDA submission for the Initial Licensed Product [*] U.S. Dollars (US$[*]) Upon Marketing Approval for the Initial Licensed Product [*] U.S. Dollars (US$[*])