Development Candidates. If the Executive Committee determines that any Product Configuration meets the Pre-Clinical Development Criteria, and agrees to commence Pre-Clinical Activities with respect to such Product Configuration, then such Product Configuration shall be deemed to be a "Development Candidate". Product Configurations which are not designated as Development Candidates as set forth above may not become Collaboration Products; provided, any Product Configuration which was not previously selected as a Development Candidate may become a Development Candidate with the agreement of the Executive Committee.
Development Candidates. After the designation of a Development Candidate, Allergan shall prepare and deliver to ACADIA within a reasonable period, such period not to exceed […***…] the projected timing of the activities necessary to obtain Regulatory Approval for such Development Candidate. Thereafter, Allergan shall regularly (on at least a semi-annual basis) provide ACADIA with an update describing of the progress made to date towards obtaining Regulatory Approval of such Development Candidate and the plans for achieving Regulatory Approval in the future. Allergan shall have the sole responsibility for conducting preclinical and clinical development of such Development Candidate in accordance with a development plan prepared by Allergan in a manner consistent with its then existing internal criteria. Allergan agrees to use commercially reasonable efforts to fund and perform development of its Development Candidate pursuant to such development plan in Major Markets. For purposes of clarification, Allergan shall not be required under Section 6.1 or this Section 6.2 to provided detailed data or results to ACADIA.
Development Candidates. Within [***] days after either Party reasonably concludes based upon available Research Project reports that an Optimized Lead Compound for a MERCK Funded Program Target or, as applicable, a MERCK Internal Program Target or any ARCHEMIX Internal Program Target for which MERCK has provided an Additional Research Request and paid the applicable Option Fee and/or Option Exercise Fee, meets the applicable DCSC, the JPT shall review the data and information and determine whether to nominate such Optimized Lead Compound for designation as a Development Candidate. If the JPT elects to nominate any such Optimized Lead Compound as a Development Candidate, the JPT shall promptly furnish all available information to the JSC. The JSC shall consider such nomination within [***] days so as to enable MERCK to determine whether or not to continue Development of such Optimized Lead Compound, and if the Optimized Lead Compound meets the DCSC and MERCK accepts such Optimized Lead Compound for further Development, such Optimized Lead Compound shall be deemed to be a Development Candidate for purposes of this Agreement.
Development Candidates. The initial Annual Development Plan for each Development Candidate shall be prepared by MERCK and submitted to the JSC for its review within [***] days of the date on which the JSC approves the selection of such Development Candidate and in any event, on or prior to the initiation of Development activities with respect thereto, which shall describe the Development activities to be conducted for the balance of the Contract Year. Thereafter, subject to Section 4.10.5(a), for each Contract Year during the Term, an Annual Development Plan for each Development Candidate shall be prepared by MERCK and provided to the JSC for its review and MERCK shall consult with the JSC with respect to all significant Development decisions to be made with respect to such Annual Development Plan.
Development Candidates. (a) The Parties will enter into a “Development Manufacturing and Supply Agreement” between each other or among the Parties and an Affiliate or a Third Party manufacturer covering Development Candidates, no later than [***] prior to Development Candidates are first nominated or as otherwise agreed to by the Parties, which agreement will be consistent with and supersede the terms of this Section 14.2. The Development Manufacturing and Supply Agreement shall include but be not limited to the terms set forth in the termsheet attached hereto as Exhibit 14.2(a).
Development Candidates. Within [***] days after either Party reasonably concludes based upon available project reports that an Optimized Lead Compound meets the applicable DCSC, the JPT shall review the data and information and determine whether to nominate the Optimized Lead Compound for designation as a Development Candidate. If the JPT elects to nominate any such Optimized Lead Compound as a Development Candidate, the JPT shall promptly furnish all available information to the JSC. The JSC shall consider such nomination within [***] days so as to enable MERCK to determine whether or not continue Development of such compound, and if the Optimized Lead Compound meets the DCSC and MERCK accepts such Optimized Lead Compound for further Development, such Optimized Lead Compound shall be deemed to be a Development Candidate for purposes of this Agreement.
Development Candidates. (a) On a Program-by-Program basis with respect to the FA Program and each Discovery Program, prior to the applicable Transition Date, Voyager shall notify Neurocrine of potential Development Candidates that are Developed by or on behalf of Voyager under such Program. Based upon the Development Candidate Criteria and the results of Development activities with respect to the FA Program or any Discovery Program, either Party may nominate a development candidate for such Program by providing written notification thereof to the JSC.
Development Candidates. Subject to the terms and conditions of this Agreement, on a Development Candidate-by-Development Candidate basis, effective as of the date on which the Collaboration Antigen of such Development Candidate becomes a “Collaboration Antigen” under this Agreement, Unum hereby grants to SGI a co-exclusive (with Unum), sublicensable (solely as permitted in accordance with Section 10.4), worldwide license, under the Unum Background Technology and Unum Program IP, to clinically Develop Development Candidates, all in accordance with the Late Clinical Development Plan provided that such license will automatically terminate, and be of no further force or effect, with respect to any Development Candidate and associated Product for which SGI has exercised its Opt-Out Right.
Development Candidates. During the R&D Collaboration Term, the JSC or Novo may nominate one or more Compound(s) Directed To one or more Validated Target(s) (each a “Development Candidate” or “DC”) which have achieved Proof of Principle. If more than [* * *] DCs are nominated, it shall be deemed an increase in the scope of the Agreement and any DCs in excess of [* * *] shall be subject to the additional payment requirements set forth in Section 8.3.2. For the avoidance of doubt, either the JSC or Novo, in its discretion, is free to cause such increase in scope. From time to time at the reasonable request of Novo, and in any case promptly upon the end of the R&D Collaboration Term, Dicerna shall promptly provide to Novo a report including all material data generated by Dicerna regarding Validated Targets and such other information reasonably requested by Novo regarding evaluation and testing of Compounds Directed To one or more Validated Targets. Following Dicerna’s provision of such report at the end of the R&D Collaboration Term: (i) Novo shall review such report, and Novo shall notify Dicerna, no later than [* * *] after receiving such report, of any reasonable requests for additional information and records related to Compounds that is within Dicerna’s possession or control, and Dicerna shall respond to such requests within [* * *] thereof; and (ii) Novo shall have at least [* * *] following the receipt of such report to decide whether to nominate any Development Candidates, provided that such [* * *] time period shall be extended by the number of Calendar Days equal to the number of [* * *] after such [* * *] period during which Dicerna failed to provide such reasonably requested additional information, if any. Novo shall have final decision on the selection and prioritization for further testing of Development Candidates. The Parties shall collaborate in the conduct of all Research activities to DC nomination as specified in the Research Plans and Work Flow Plan, leveraging the capabilities and expertise of each Party.
Development Candidates. On and after the Designation Notice Date, Novartis shall be solely responsible, in its sole discretion (but subject to its obligations under this Agreement (including Section 6.2.1)), for Developing SMA Development Candidates, including the selection of an SMA Program Payload to utilize with an SMA Program Capsid. Novartis shall notify Voyager in writing promptly upon (in any event, no greater than [**] after) the designation of any SMA Development Candidate.
