Clinical Development Activities. (i) With respect to any ongoing Clinical Trials with respect to the Terminated Country(ies) of Terminated Products for which EPIZYME has not notified CELGENE prior to the effective date of termination that it wishes to assume responsibility, CELGENE shall, at CELGENE’s cost and expense, complete such Clinical Trials, subject to Section 2.7.1, only with regard to those patients enrolled at the date of termination and may otherwise cease enrollment and cancel all cancelable expenses relating to such Clinical Trials; and
Clinical Development Activities. (i) With respect to any ongoing clinical trials of Terminated Products for which EPIZYME has not notified GSK prior to the effective date of termination that it wishes to assume responsibility, GSK shall, at GSK’s cost and expense, complete such clinical trials only with regard to those patients enrolled at the date of termination and may otherwise cease enrollment and cancel all cancelable expenses relating to such clinical trials. Notwithstanding the foregoing, GSK may prematurely suspend or terminate any such trial if (A) a priori protocol defined stopping rules are met for safety or efficacy or (B) unacceptable safety signals are observed by GSK or the Data and Safety Monitoring Board with respect to any Terminated Product that present an unacceptable risk to patients participating in such trials; and
Clinical Development Activities. With respect to any clinical Development activities that are in progress at the time of notice of termination, (i) EPIZYME may elect, in its sole discretion, to complete such clinical Development activities, in which event EISAI shall transfer to EPIZYME all such clinical Development activities as part of the transition plan to be mutually agreed by the Parties under clause (c) above, at EPIZYME’s expense, or (ii) if EPIZYME does not elect to complete such clinical Development activities, EISAI shall promptly discontinue or wind-down, at EISAI’s cost, any such clinical Development activities, and forward all interim and final reports and underlying data from such activities to EPIZYME.
Clinical Development Activities. With respect to any clinical Development activities in the EISAI Territory that are in progress at the time of notice of termination, (i) EPIZYME may elect, in its sole discretion, to complete such clinical Development activities, in which event EISAI shall transfer to EPIZYME (or its designee) all such clinical Development activities as part of the transition plan to be mutually agreed by the Parties under clause (c) above, at EPIZYME’s expense, or (ii) if EPIZYME does not elect to complete such clinical Development activities, EISAI shall promptly discontinue or wind-down, at EISAI’s cost, any such clinical Development activities, and forward all interim and final reports and underlying data from such activities to EPIZYME (or its designee).
Clinical Development Activities. With respect to any clinical Development activities of Novartis directed to the Products with respect to the terminated countries that are in progress at the time of notice of termination, at XOMA’s election prior to the effective date of termination, Novartis shall to the extent not prohibited by applicable Law or any Regulatory -35- Certain confidential portions of this exhibit have been omitted and replaced with “[***]”. such identified information has been excluded from this exhibit because it is (i) not material and (ii) would likely cause competitive harm to the company if disclosed. Authority transfer to XOMA any such clinical Development activities, including responsibility for payment of all fees, costs and expenses associated with such clinical Development activities, and forward all interim and final reports and underlying data from such activities to XOMA to enable such clinical Development activities to be transferred to XOMA without interruption. Such transfer shall [*] in accordance with Section [*], unless [*] in accordance with Section [*], in which case [*].
Clinical Development Activities. (a) The Parties shall, at any time, cooperate in good faith and use all their Commercially Reasonable Efforts to pursue and complete their roles in the clinical Development activities of Licensed Products as assigned to the Parties in the Clinical Development Plan with the goal of obtaining regulatory approvals in each of the Major Markets as well as any other jurisdiction within the Licensed Territory as mutually agreed by the Parties and is reasonably required to successfully exploit the License for the commercial benefit of both Parties.
Clinical Development Activities. With respect to any clinical Development activities of Novartis directed to the terminated Product or Products with respect to the terminated countries that are in progress at the time of notice of termination, (a) Novartis shall [*]; or (b) at XOMA’s election prior to the effective date of termination, Novartis shall to the extent not prohibited by applicable Law or any Regulatory Authority[*] transfer to XOMA any such clinical Development activities and forward all interim and final reports and underlying data from such activities to XOMA to enable such clinical Development activities to be transferred to XOMA without interruption; [*]
Clinical Development Activities. Subject to Section 3.1, Novo shall use Commercially Reasonable Efforts to conduct all Development activities from IND Approval through Commercialization on at least [* * *] Development Candidates, provided that at least [* * *] Development Candidates are selected for Development Candidate nomination. If more than [* * *] Development Candidates are selected, then Novo shall, subject to the immediately preceding sentence, have the right to prioritize its Development efforts among such Development Candidates.
Clinical Development Activities. Hengrui shall be responsible for all Development Activities associated with clinical Development and Regulatory Approval of the Licensed Antibodies and Licensed Products in the Hengrui Territory. Subject to Section 4.1.6, Incyte shall be responsible for all Development Activities associated with clinical Development and Regulatory Approval of the Licensed Antibodies and Licensed Products in the Incyte Territory.
Clinical Development Activities. (a) Lilly will use Commercially Reasonable Efforts to complete the Ongoing Lilly Trials, and any follow-on analysis and reporting and filing results with the FDA with respect thereto.
