Development Responsibilities and Costs. GlobeImmune shall have responsibility for conducting Development activities set forth in the Initial Development Program for each Program prior to exercise by Celgene of the Celgene Program Option for such Program as set forth in the Initial Development Plan. GlobeImmune shall conduct such Development activities in compliance with all material applicable legal and regulatory requirements, including all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials. GlobeImmune shall be responsible for conducting all Development activities related to Future Programs prior to exercise by Celgene of the Celgene Program Option for such Future Program. Within sixty (60) days after the Effective Date and thereafter prior to each JRC meeting, as necessary, GlobeImmune will prepare a proposed update to the then-current Initial Development Plan to specify the activities to be performed based on the stage of Development of the Drug Candidates at the time of such update. GlobeImmune shall deliver each proposed update to Celgene in the form of an amended Initial Development Plan, and the Parties will negotiate in good faith to adopt such amended Initial Development Plan (with such modifications agreed to by the Parties).
Development Responsibilities and Costs. Celgene, at its sole cost and expense, shall have responsibility for conducting all Development activities with respect to any Program (and all applicable Celgene Development Compounds therein) following exercise of a Celgene Program Option with respect to such Program. Celgene shall conduct such activities in compliance with all applicable legal and regulatory requirements, including all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials after exercise of the Celgene Program Option.
Development Responsibilities and Costs. Retrophin shall have sole responsibility for, and shall bear the cost of conducting, all Development with respect to the Licensed Compounds and Licensed Products.
Development Responsibilities and Costs. The Parties have agreed upon an initial development plan, timeline and related budget for GlobeImmune’s Development activities hereunder attached hereto as Exhibit C (as amended by the JRC from time to time, the “Collaboration Development Plan”), which includes, without limitation, a description of the plan and timeline for GlobeImmune to [*]. In accordance with, and subject to, the Collaboration Development Plan, GlobeImmune shall, using Commercially Reasonable Efforts:
Development Responsibilities and Costs. [*] (the “Gilead Development Plan”). Such Gilead Development Plan shall be determined by Gilead in its sole discretion. From time to time during the Term, Gilead may amend the Gilead Development Plan, in Gilead’s sole discretion, and shall provide GlobeImmune with an updated copy thereof on an annual basis, except that Gilead shall promptly provide to GlobeImmune an update copy thereof upon any material change to such Gilead Development Plan. Gilead shall conduct such Development activities in compliance with all material applicable legal and regulatory requirements, including all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials, including, without limitation, GCP and GLP.
Development Responsibilities and Costs. As between the Parties, Eiger shall have sole responsibility for, and shall bear the cost of conducting, research and Development with respect to the Licensed Compounds and/or Licensed Products. Eiger shall research and Develop the Licensed Compounds and/or Licensed Products in compliance with all applicable Laws, including all legal and regulatory requirements pertaining to the design and conduct of clinical studies.
Development Responsibilities and Costs. As between the Parties, Company shall have sole responsibility for, and shall bear the cost of conducting, research and Development with respect to the Licensed Compounds and/or Licensed Products. Company shall research and Develop the Licensed Compounds and/or Licensed Products in compliance with all applicable Laws, including all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials.
Development Responsibilities and Costs. As between the Parties, Company shall have sole responsibility for, and shall bear the cost of conducting, research and Development with respect to the Licensed Compounds and/or Licensed Products. Company shall research and Develop the Licensed Compounds and/or Licensed Products in compliance with all applicable Laws, including all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials. For clarity, BMS shall be responsible for the payment of all payment obligations to any third Parties pursuant to licenses obtained by BMS with respect to any Third Party Know How or Third Party Patent Rights included in the BMS Know-How or BMS Patent Rights, respectively, except with respect to Third Party Compensation, which shall be determined pursuant to 8.4.4(a).
Development Responsibilities and Costs. Monopar, at its sole cost and expense, shall have responsibility for conducting, and shall use Commercially Reasonable Efforts to conduct, all Development activities with respect to Licensed Products following exercise of the Monopar Validive Option.
Development Responsibilities and Costs. OncoMed shall have responsibility for conducting all Development activities, including without limitation PoC Trials, for each Collaboration Compound prior to exercise by GSK of the GSK Program Option for such Collaboration Compound. OncoMed shall conduct all such Development activities up to and including the PoC Trials in compliance with all material Laws including without limitation all legal and regulatory requirements pertaining to the design and conduct of Clinical Trials. The Parties agree to cooperate during the Research Collaboration Term in identifying and implementing opportunities to reduce the costs incurred by OncoMed in the conduct of Development of Collaboration Compounds. After exercise of a GSK Program Option, such responsibilities and costs shall be determined in accordance with Section 4.2.4.
