Pre-Clinical Development. The Parties, under the direction of the RMC shall conduct Pre-Clinical Development with respect to any designated Collaboration Lead Compound. The costs of conducting such Pre-Clinical Development shall be shared by the Parties as set forth in Section 3(f). Under no circumstances shall either Party conduct studies of any Collaboration Lead Compound in the Field except as permitted by the RMC.
Pre-Clinical Development. 3.1 Responsibility for the Pre-Clinical Work Plan. ADCT shall be responsible for the execution of the Pre-Clinical Work Plan. The Pre-Clinical Work Plan is set forth in Schedule 2 of this Agreement. Genmab shall provide up to [**] hours of Technical Support in support of the Pre-Clinical Work Plan as reasonably requested by ADCT at no cost to ADCT. Genmab may, at its discretion, provide additional Technical Support to ADCT at any time as requested by ADCT under the FTE Rate.
Pre-Clinical Development. Subject to Alizyme complying with its obligations under the Development Plan, Alizyme shall solely control, assume all responsibility for, and fund all ongoing and additional Pre-Clinical Studies for the Product reasonably necessary to support Regulatory Filings for the First Indication in the Prometheus Territory in accordance with the Development Plan, provided that Alizyme shall (a) keep Prometheus reasonably informed with respect to such Pre-Clinical Studies, (b) provide Prometheus with copies of all relevant correspondence received from and to be provided to, Regulatory Authorities concerning such Pre-Clinical Studies, and (c) consider in good faith all reasonable suggestions and comments provided by Prometheus with respect to such Pre-Clinical Studies and/or correspondence with the Regulatory Authorities. If Alizyme fails to comply with its obligations under the Development Plan as provided in Section 3.8.1(b) with respect to its proper and timely conduct of the Pre-Clinical Studies, Prometheus shall have the right, in addition to any other rights or remedies under this Agreement or applicable Law, to conduct and control such Pre-Clinical Studies as specified in the Development Plan and Alizyme shall promptly reimburse Prometheus for Prometheus' Fully-Burdened Costs incurred in connection therewith.
Pre-Clinical Development. The JRC will review the characteristics of the Collaboration Compounds identified under the Research Program, and the JRC will attempt to select certain Collaboration Compounds to be recommended to Organon for further work in the Field as a "Collaboration Lead Compound". Further, Organon shall have the right in its sole discretion, but without the obligation, during the Term of the Agreement to select (either on its own or in response to a recommendation from the JRC) Collaboration Compounds or Background Technology compounds for such further work in the Field. Upon a written recommendation by the JRC, Organon will use diligent efforts to conduct all needed studies on such Collaboration Compound or Background Technology compound to determine if such Collaboration Compound or Background Technology compound shall be selected by Organon as a "Collaboration Lead Compound" and shall make such selection within *** (***) *** of such recommendation by the JRC. If so selected, Organon shall conduct Pre-Clinical Development of each such selected Collaboration Compound in such manner as Organon shall determine in its sole discretion, upon availability of an adequate supply of the Collaboration Compound for Pre-Clinical Development and Phase I, and shall inform Ligand and the JRC of the progress and results thereof. If not selected, then Ligand shall have the right ***(***) *** following the date of recommendation by the JRC to develop and commercialize the compound as if it were an abandoned Collaboration Compound in accordance with Section 5.3.1 *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Ligand Initial [/s/WR] Organon Initial [/s/JV] if the abandoned Collaboration Compound is based on a chemical template originated by Ligand.
Pre-Clinical Development. Subject to the terms and conditions of this Agreement, (i) in each case to the extent set forth in this Agreement, the Handoff Activities Exhibit or the Research Plan, Precision shall be responsible for Manufacture of each Licensed Product to support Pre-Clinical Development up to the Handoff Point, and (ii) Prevail shall be responsible for all other Manufacture of each Licensed Product to support Pre-Clinical Development.
Pre-Clinical Development. Upon prior written consent from Inovio, Advaccine may conduct pre-clinical studies to generate and obtain Data that is reasonably useful for the Development of any Product in the Field in the Advaccine Territory, provided that Advaccine shall promptly amend the Development Plan to include such pre-clinical studies and submit such amendment to the JSC for review.
Pre-Clinical Development. During the Pre-Clinical Program Term, 3BP will conduct the Pre-Clinical Development activities assigned to 3BP in the Global Development Plan for the Lead Candidate set forth in Exhibit 1.69 and other Lead Candidates as agreed in accordance with the process in Sections 2.2(b), 2.5(b), 2.5(c) and 3.1 (and any Backup Candidates, as applicable) in accordance with the timelines stated therein. 3BP may utilize Third Party subcontractors to perform certain of its Pre-Clinical Development activities, in connection with which the Parties will prepare for approval by the JSC a budget for the Development Costs anticipated to be incurred by 3BP through its Third Party subcontractors. In support of 3BP’s Pre-Clinical Development activities, Clovis agrees to pay 3BP in accordance with the terms of Section 8.2 the FTE Costs for up to [***] ([***]) FTEs of 3BP who are devoted to conducting such work and agrees to pay in accordance with the terms of Section 8.3(a) the costs of any Third Party subcontractor engaged by 3BP in the Pre-Clinical Development activities, provided such subcontractor is expressly mentioned in the Global Development Plan and such costs are incurred in accordance the above-mentioned budget approved by the JSC.
Pre-Clinical Development. During the Term, for each applicable Collaboration Target, including ROR1, each Party shall have the right to direct the other Party to direct Cellectis, pursuant to the applicable Cellectis Agreement, to complete pre-clinical research and development of Cellectis CARs directed to XX00, XXX0 or EGFRVIII, as applicable. In the event that a Party is interested in having Cellectis complete pre-clinical research and development of Cellectis CARs directed to XX00, XXX0 or EGFRVIII (the “Cellectis Work”) then such Party will notify the JRDC in writing and include in such notification the work which such Party intends to have Cellectis perform. Following receipt of such notification, the JRDC will discuss such proposed Cellectis Work at the next scheduled JRDC meeting, if not sooner, and either agree to include such Cellectis Work in the Global Research and Development Plan or not. If the JRDC agrees to include such Cellectis Work as part of the Global Research and Development Plan then any costs associated with such Cellectis Work will be treated as Development Costs. If the JRDC does not agree to include such Cellectis Work in the Global Research and Development Plan then:
Pre-Clinical Development. Without limitation on the provisions of this Agreement concerning the Research Collaboration, BI will be responsible for carrying out the pre-clinical and clinical Development of Collaboration Compounds, including the major activities and related target timelines set forth in the Master Development Plan, and shall use Reasonable Commercial Efforts. BI shall report to Zealand concerning pre-clinical Development at meetings of the PSC, such report to include the items described in Appendix 4.2. BI shall [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. have final decision-making authority regarding such pre-clinical and clinical Development, without limitation on its diligence obligations hereunder.
Pre-Clinical Development. 7.1 Memory, at its sole cost, shall pursue further pre-clinical development of any Pre-clinical Candidate and other preclinical candidates selected by it.
7.2 [*].
