Control over Development and Commercialization. If Xxxxxxx exercises the Xxxxxxx Option, Xxxxxxx shall use Diligent Efforts to Develop a Licensed Product for a first indication in the United States and each Major European Market. Xxxxxxx shall keep and maintain all records required by law or regulation with respect to Licensed Products. Xxxxxxx shall use Diligent Efforts to conduct the Phase III Development Plan and Xxxxxxx shall be solely responsible for all costs and expenses associated therewith. Xxxxxxx shall have the right to modify such Phase III Development Plan from time to time in Xxxxxxx’x reasonable judgment to meet its obligations of Diligent Efforts hereunder. Xxxxxxx will use Diligent Efforts to Commercialize the Licensed Product in the United States and each Major European Market. Without limiting the generality of the foregoing, Xxxxxxx shall undertake the commercial launch of the Licensed Product in the U.S. promptly after, and in any case not later than [*] ([*]) months after, the date upon which Regulatory Approval is granted in the United States. In addition, Xxxxxxx shall undertake the commercial launch of such Licensed Product in each Major European Market promptly after, and in any case not later than [*] ([*]) months after, the date upon which Regulatory Approval is granted in such Major European Market. Xxxxxxx shall promptly notify PPD in writing of the First Commercial Sale of such Licensed Product in the U.S. and each Major European Market.
Appears in 8 contracts
Samples: Development and License Agreement (Pharmaceutical Product Development Inc), Development and License Agreement (Pharmaceutical Product Development Inc), Mudelta Development and License Agreement (Furiex Pharmaceuticals, Inc.)
Control over Development and Commercialization. If Xxxxxxx PPD exercises the Xxxxxxx PPD Option, Xxxxxxx PPD shall use Diligent Efforts to Develop a conduct further Development of the Licensed Product for a first indication in the United States and each Major European Market, and PPD shall be solely responsible for all costs and expenses it incurs with respect thereto. Xxxxxxx PPD shall keep and maintain all records required by law or regulation with respect to Licensed Products. Xxxxxxx shall use Diligent Efforts to conduct the Phase III Development Plan and Xxxxxxx shall be solely responsible for all costs and expenses associated therewith. Xxxxxxx PPD shall have the right to modify such Phase III its Development Plan Plans from time to time in Xxxxxxx’x reasonable PPD’s reasonably judgment to meet its obligations of Diligent Efforts hereunder. Xxxxxxx will PPD shall use Diligent Efforts to Commercialize the such Licensed Product in the United States and each Major European MarketMarkets. Without limiting the generality of the foregoing, Xxxxxxx PPD shall undertake the commercial launch of the Licensed Product in the U.S. promptly after, and in any case not later than [*] ([*]) months after, the date upon which Regulatory Approval is granted in the United States. In addition, Xxxxxxx PPD shall undertake the commercial launch of such Licensed Product in each Major European Market promptly after, and in any case not later than [*] ([*]) months after, the date upon which Regulatory Approval is granted in such Major European Market. Xxxxxxx PPD shall promptly notify PPD Xxxxxxx in writing of the First Commercial Sale of such Licensed Product in the U.S. and each Major European Market.
Appears in 8 contracts
Samples: Development and License Agreement (Pharmaceutical Product Development Inc), Development and License Agreement (Pharmaceutical Product Development Inc), Mudelta Development and License Agreement (Furiex Pharmaceuticals, Inc.)