Designation of Development Candidates. Biogen Idec shall have complete discretion during the Term as to the designation of any Target Selective Compound within the Field as a Development Candidate by providing written notice to Sunesis of such designation. Notwithstanding the foregoing, it is understood and agreed that if Biogen Idec undertakes GLP toxicity studies or GMP manufacturing with respect to a particular Target Selective Compound, such Target Selective Compound shall be deemed designated by Biogen Idec as a Development Candidate for the purposes of Sections 3.3 and 7.3.
Designation of Development Candidates. From time to time during the Initial R&D Term, either Party may nominate one or more Compounds to the JRC for consideration as a candidate for Development under a POC Development Plan (the “Development Candidate”). Such nomination (and approval thereof by the JRC) shall be made prior to the initiation of the IND-enabling studies for such Compound(s), unless the Parties otherwise agree. Promptly after such nomination, each Party shall present to the JRC the data and results it has obtained with respect to such Compound(s) as well as, if requested by the other Party, written records (such as lab notebooks) maintained by or on behalf of such Party or its Affiliates with respect to the discovery and/or development history of such Compound, and the JRC shall determine whether such Compound(s) shall be approved as a Development Candidate under this Agreement. If the JRC determines not to approve such Compound(s) as a Development Candidate, then the JRC shall inform the Parties in writing of such decision, as well as the reasons thereof. The JRC may also request that further Research activities be conducted with respect to such Compound(s) (under an amended Research Plan), after which such Compound(s) may be reconsidered for nomination as a Development Candidate. If the JRC (or the ESC or Designated Senior Officers, as applicable) approve a particular Compound as a Development Candidate, then the Parties shall proceed to conduct further Development of such Compound (including IND-enabling studies, other pre-clinical and non-clinical studies, and clinical studies) pursuant to a Development Plan (as further described in Section 5.2) and under the oversight of the GDC. In addition, at any time after a Compound is designated as a Development Candidate, if requested by either Party, the other Party shall make available written records (such as lab notebooks) maintained by or on behalf of such Party or its Affiliates with respect to the discovery and/or development history of such Compound or any Product under Development that contains such Compound, in each case for the purpose of conducting freedom-to-operate analysis in connection therewith, such request shall not be made more than once for each Compound or each Product, as applicable, except for cause. Notwithstanding the foregoing, as of the Effective Date, the Parties agree that the Compounds set forth on Exhibit G are deemed Development Candidates under this Agreement.
Designation of Development Candidates. The parties acknowledge that Biogen Idec has not, as of the Effective Date, designated a Development Candidate with respect to the Collaboration Target. For clarity, all Research Milestones remain payable for such Development Candidate pursuant to Section 7.3 (except as expressly provided therein). Biogen Idec shall have complete discretion during the Term as to the designation of any Target Selective Compound within the Field as a Development Candidate by providing written notice to Sunesis of such designation. Notwithstanding the foregoing, it is understood and agreed that if Biogen Idec undertakes GLP toxicity studies or GMP manufacturing with respect to a particular Target Selective Compound, such Target Selective Compound shall be deemed designated by Biogen Idec as a Development Candidate for the purposes of Sections 3.3 and 7.3.
Designation of Development Candidates. (a) Following nomination of a Program Compound that is a CCB LDD as a Development Candidate by Celgene, the JSC shall discuss and review, and Celgene shall in its sole discretion determine, whether such Program Compound meets the Development Candidate Criteria. During the Research Term or, pursuant to Section 2.3.3(b), at the end of the Research Term, following nomination of a Program Compound that is not a CCB LDD as a Development Candidate, the JRC shall determine, or, in the event that the JRC is unable to unanimously agree, the JSC shall determine, whether such Program Compound meets the Development Candidate Criteria as follows: (i) any such determination by the JRC or JSC, as applicable, must be
Designation of Development Candidates. Allergan and ACADIA shall each designate their own Development Candidates in accordance with the licenses granted hereunder and otherwise in accordance with the terms of this Agreement. Allergan and ACADIA agree that each of them cannot develop an Active Compound or a Derivative Compound without designating such compound as a Development Candidate. Notwithstanding any other provision of this Agreement, however, (i) Allergan shall not be permitted to designate as an Allergan Development Compound an Active Compound [***] that has been previously designated by ACADIA as an ACADIA Development Compound and (ii) ACADIA shall not be permitted to designate as an ACADIA Development Compound an Active Compound [***] that has been previously designated by Allergan as an Allergan Development Compound.
Designation of Development Candidates. From time to time during the Research Term, either Party may nominate a DTC or Research Compound as a potential Development Candidate for the JSC’s consideration. Promptly after such nomination, each Party shall present to the JSC the data and results it has obtained with respect to such DTC or Research Compound, and the JSC shall determine whether such DTC or Research Compound shall be approved as a Development Candidate or whether additional research activities should be conducted with respect to such DTC Research Compound, after which such DTC or Research Compound may be reconsidered for designation as a Development Candidate. If the JSC approves a particular DTC or Research Compound as a Development Candidate, then the Parties shall proceed to IND-enabling studies of such DTC or Research Compound during the Research Term as set forth in the Research Plan.
Designation of Development Candidates. Following completion of Lead Optimization for a Collaboration Antibody, Enumeral will provide the JSC with a written report summarizing the results of the screening activities and assessments on the Collaboration Antibody (each, a “Development Candidate Notice”). Promptly following the receipt of a Development Candidate Notice, the JSC will meet and review the data and information and decide whether to designate the Collaboration Antibody as a Development Candidate. If the JSC provides written notice to the Parties designating a Collaboration Antibody as a Development Candidate, the Collaboration Antibody will be deemed a Development Candidate for purposes of this Agreement as of the date of receipt of the Development Candidate Notice, and the Parties will prepare a Development Plan.
Designation of Development Candidates. The JSC shall review and discuss from time to time the status of Compounds and whether or not any Compound meets the Development Candidate Criteria, or should otherwise be determined to be appropriate for the commencement of IND-Enabling Studies. Any such Compound so approved by the JSC to have met the Development Candidate Criteria or otherwise be appropriate for the commencement of IND-Enabling Studies shall be deemed a Development Candidate. Any disagreement with respect to whether such Development Candidate Criteria have been met, or whether a Compound otherwise is appropriate for the commencement of IND-Enabling Studies shall be subject to Biogen’s final decision-making authority in accordance with Section 4.2.4 (Decision Making Authority). For clarity, at any time during the Term, Biogen shall nonetheless have the right to determine whether any Compound meets the Development Candidate Criteria or otherwise is appropriate for the commencement of IND-Enabling Studies. As used in this Agreement, “Development Candidate” means each Compound (a) that meets the Development Candidate Criteria (whether determined by the JSC or Biogen); (b) that does not meet the Development Candidate Criteria but nonetheless is determined by the JSC (or by Biogen) as appropriate for the commencement of IND-Enabling Studies, or (c) for which Biogen otherwise elects to commence IND-Enabling Studies.
Designation of Development Candidates. (a) The Parties have established Development Candidate Criteria, set forth in Exhibit 1.9.3 for the nomination of Development Candidates. From time to time during the Research Term, Biogen may approve the designation of any Compound within the Field as a Development Candidate by written notice to Sunesis, provided such Compound either (i) meets the Development Candidate Criteria, or (ii) was recommended by the JRC.
(b) Biogen’s right to specify a Development Candidate shall survive the expiration of the Research Term and shall continue for a period of three (3) years following the expiration of the Research Term, provided, Sunesis has not already granted a Third Party the right to exploit such designated Compound. Subject to the foregoing, it is understood and agreed that if Biogen undertakes GLP toxicity studies with respect to a particular Compound, such Compound shall be deemed designated by Biogen as a Development Candidate (and if such Compound has not already been designated as a Lead Compound, it shall also be deemed designated by Biogen as a Lead Compound).
Designation of Development Candidates
