Overall Efforts in Development. Acucela and Otsuka shall establish and implement the Development Plan in a prompt and expeditious manner with respect to Collaboration Products within the Field. The Parties agree that the Development Plan shall focus on Development necessary for the registration of the Collaboration Product in the United States until such time as the JCC shall determine whether to proceed with Development and Commercialization in other countries of the Shared Territory. The Parties shall use Commercially Reasonable Efforts to ensure that the Development Plan provides at all times for adequate resources to achieve such results in an expeditious and efficient manner.
Overall Efforts in Development. (a) Prior to the Full Participation Point, La Jolla shall use its best efforts to prepare for the filing and prosecution and to maintain the NDA for the Product in the United States and the MAA in the European Union and shall otherwise conduct all development activities with respect to Products for the Territory in accordance with the Operating Plan/Budget, subject to the oversight of the JSC and the Working Group; provided that La Jolla is not hereby guaranteeing that the FDA will issue the NDA or that the EMEA will issue the MAA. Unless otherwise agreed by the Parties, BioMarin CF will not perform any development activities under the Operating Plan/Budget other than manufacturing related activities prior to the Full Participation Point. Prior to the Full Participation Point, La Jolla shall use diligent efforts to implement the Operating Plan/Budget in a prompt and expeditious manner and in a manner designed to obtain Marketing Approvals for the existing Product in the United States and the European Union; and La Jolla shall use diligent efforts to ensure that the Operating Plan/Budget provides at all times for adequate activities, resources and funding to achieve such results in an expeditious and efficient manner. Notwithstanding the foregoing prior to the Full Participation Point, such obligations shall not require La Jolla to initiate or conduct an efficacy trial in humans other than the ASPEN Study. The foregoing diligence obligations shall not apply if there is a Futile Determination or, if based upon receipt of the 128 Flare Topline Data, the ASPEN Study does not result in a P-Value Achievement. The Parties acknowledge that the up front payments to be, and such additional payments as are described in Sections 7.2-7.4 and 7.13(b) as may be, paid by BioMarin CF are in support of La Jolla’s conduct of the ASPEN Study and other research and development activities with respect to the Compound and Products and accordingly, prior to the Full Participation Point, La Jolla agrees that it shall not fund the development of any product, other than the Compound and Products if such funding causes La Jolla’s remaining net available cash to be less than one hundred ten percent (110%) of the amount reasonably necessary to fund the Operating Plan/Budget through receipt of the 128 Flare Topline Data. For clarity, subject to the preceding sentence, La Jolla may conduct research and development activities for any other programs or products.
Overall Efforts in Development. Amicus and Shire shall establish and implement the Development Plans in a prompt and expeditious manner with respect to each Licensed Product within the Field, and in a manner that harmonizes the Development of Licensed Products within the Field towards (a) a common registration dossier as a basis for license applications in the Primary Markets and, to the extent described in Section 4.2.5(e) below, Japan, and (b) Regulatory Approval for such Licensed Product in each of the Primary Markets. The Parties shall use Commercially Reasonable Efforts to ensure that each Development Plan provides at all times for adequate resources to achieve such result in an expeditious and efficient manner.
