Alvogen Responsibilities Clause Samples

Alvogen Responsibilities. (a) Alvogen shall use Diligent Efforts to conduct the development activities assigned to Alvogen for Product in the Territory set forth in the Development Plan and associated timelines and such activities shall be conducted in accordance with applicable cGxP and Applicable Law with the goal of supporting the preparation and filing of an NDA for the Product and obtaining NDA Approval for the Product. (b) After the Milestone Payment, Alvogen shall (unless otherwise provided in the Development Plan): (i) have the sole right and responsibility, and bear all costs, for all regulatory matters relating to the Product, and Alvogen shall own all Regulatory Materials and Regulatory Approvals for the Product in the Territory. NRx hereby assigns to Alvogen all of its right, title and interest in and to all Regulatory Materials and Regulatory Approvals for the Product in the Territory, and agrees to execute and deliver all documents and instruments reasonably requested by Alvo▇▇▇ ▇▇ effect, evidence or record the foregoing assignment. Alvogen shall (itself or, subject to ‎Section 3.3, through its Affiliates or Third Parties) use Diligent Efforts to file with the FDA and defend the NDA for Product and obtain NDA Approval for Product with the Initial Label Indication. In connection with the filing and review of such NDA, Alvogen shall apply for and use Diligent Efforts to obtain a waiver (or reduction) with respect to the PDUFA Fee, as provided in 21 U.S.C. 379h(d); provided, however, if despite such Diligent Efforts, the FDA notifies Alvogen that any PDUFA Fee is payable, then the Parties shall share the cost of such PDUFA Fee in accordance with their Pro-Rata Portion. Accordingly, NRx shall remit its share of the PDUFA Fee to Alvogen within ten (10) Business Days of receipt of an invoice therefor from Alvogen (ii) be responsible for and use Diligent Efforts to conduct (itself or, subject to ‎Section 3.3(c), through its Affiliates or Third Parties) (A) all Regulatory Commitment Activities and post-marketing surveillance studies and data collection and analysis with respect to Product for the Field in the Territory; (B) all pharmacovigilance activities with respect to Product in the Territory (subject to the PV Agreement); and (C) all medical investigations and evaluations and the reporting of Adverse Drug Responses related to Product in the Territory, in each case (clauses (A) – (C)) as required by the FDA or under Applicable Law (collectively, the “Commitment Activitie...