Common use of Light Study Clause in Contracts

Light Study. The Parties acknowledge and agree that as of the Amended and Restated Effective Date, the current design of the CVOT PMR Study satisfies FDA and, to the Parties’ knowledge, EMA requirements for, and to support and maintain, Regulatory Approval in the Territory and regulatory approval in the EU. Takeda agrees to consider in good faith amendments to the current design of the CVOT PMR Study proposed by Orexigen to the extent Takeda deems such proposed amendments as necessary to maintain Orexigen’s regulatory approval in the EU; provided, however, that any such amendment to the current design of the CVOT PMR Study is subject to approval by the FDA, and any incremental Development Costs related to any such amendment shall be borne solely by Orexigen to the extent provided in Section 2.2.2(b)(iii). For the avoidance of doubt, Takeda has final decision-making authority pursuant to Section 5.7.3(a)(i) with respect to a Dispute regarding Development Post-Approval Activities, including with respect to the design of the CVOT PMR Study.