Selection of Development Candidate. When either Party (whether or not the Lead Developing Party) believes that a Compound or Compound Series is ready for final toxicology studies and suitable for development as a Joint Development Compound, such Party shall submit a written notice of Development Option and a written proposed Development Plan to the other Party and the Collaboration Management Team. The proposed Development Plan shall include, without limitation, reasonably detailed strategies and plans for: (i) pre-clinical research; (ii) clinical testing; (iii) manufacturing development (i.e., active pharmaceutical ingredients, formulation, stability, process, etc.); (iv) preparing and filing INDs; (v) preparing and filing NDA's; and (vi) otherwise obtaining Regulatory Approvals. The other Party shall have sixty (60) days to review the proposed Development Plan and to decide whether to exercise the Development Option with respect to such Compound or Compound Series and to proceed with joint development of the Compound or Compound Series under the terms of this Agreement. Regardless of the other Party's decision, the Selected Target for the nominated Compound or Compound Series shall remain in the Research Program until it has been abandoned through written mutual or unilateral action of the Parties. Upon exercising a Development Option, the Parties shall submit Research Reconciliation Reports pursuant to Section 9.2.
Selection of Development Candidate. During the relevant Research Collaboration Term, using the Candidate Selection Criteria and Target Product Profile as a guide, Regulus shall use Diligent Efforts to conduct studies under each Research Program that it determines appropriate to Develop a Development Candidate, and to select [...***...] Collaboration Compound that it determines has met the Candidate Selection Criteria. Upon such determination, Regulus shall seek confirmation by the JSC that such Collaboration Compound meets the Candidate Selection Criteria. The JSC shall review all relevant information and study results concerning each such proposed Development Candidate, and, if the JSC unanimously confirms such selection, then (x) such Collaboration Compound shall be designated a Development Candidate, (y) the Parties shall agree upon an Early Development Plan for such Development Candidate, and (z) following JSC approval of such Early Development Plan, the Early Development Program for such Development Candidate shall commence in accordance with Section 3.5. If the JSC does not confirm that such Collaboration Compound meets the Candidate Selection Criteria, then the procedures set forth in Section 3.4.3 shall apply.
Selection of Development Candidate. Within [* * *] after Avidity delivers a complete Data Package (which the Parties agree is accurate and complete in all material respects) to the JRC, the JRC shall determine whether a Development Candidate should be further optimized by the Parties under and pursuant to the Research Plan. Upon designation of a Development Candidate for further development under this Agreement, the Parties shall perform such additional Research allocated to them under the applicable Research Plan for formulation of a Product and further optimization of such Product. If the [* * *] time period lapses without a decision by the JRC, then the dispute resolution provisions of Section 2.7 shall apply, with [* * *] having the final authority on the determination of whether a Development Candidate should not be further developed under this Agreement. If the JRC (or the Executive Officers or [* * *], in the case of the preceding sentence where the [* * *] time period lapses without a decision by the JRC) determines that a Development Candidate should not be further developed under this Agreement, the applicable Collaboration Target will cease to be a Collaboration Target and will be a Discontinued Target subject to Section 4.7. Subject to Section 4.2.2 (including the maximum number of Replacement Targets set forth in Section 4.2.2), Lilly may elect to replace such Discontinued Target with a Replacement Target. For avoidance of doubt, if Lilly has expressed in such [* * *] period its intention to pursue a Development Candidate for further optimization, then the end of the [* * *] period shall not itself result in the Collaboration Target becoming a Discontinued Target unless and until determined by the JRC (or the Executive Officers or [* * *]).
Selection of Development Candidate. On an Available Target-by-Available Target or Selected Target-by-Selected Target basis, as applicable, the JRC shall determine whether or not a Compound satisfies the applicable Development Candidate Selection Criteria; [**]. Upon the earlier of: (a) determination that any Compound satisfies the applicable Development Candidate Selection Criteria pursuant to the preceding sentence, or (b) the effectiveness of an IND with respect to a Compound, such Compound shall be deemed a Development Candidate for all purposes hereunder. On an Available Target-by-Available Target or Selected Target-by-Selected Target basis, as applicable, once an applicable Compound has met the Development Candidate Selection Criteria or has been deemed to be a Development Candidate, upon CELGENE’s request or at any time upon the mutual agreement of the Parties, the Parties shall work together to develop a Development Plan for such Compound and such Available Target or Selected Target, as applicable; provided that, unless otherwise agreed by the Parties, activities under such Development Plan shall not commence prior to the effectiveness of an IND with respect to such Compound and such Selected Target.
Selection of Development Candidate. As between the Parties, Praxis shall have the right to select the Development Candidate and any Related Compound(s) and make other decisions allocated to Praxis under the Ionis Agreement; provided that Praxis shall consult with RogCon (through the Coordination Committee) and take into consideration RogCon’s positions with respect thereto.
Selection of Development Candidate. On a Selected Target-by-Selected Target basis, the JPT shall make a recommendation as to whether or not a Compound satisfies the applicable Development Candidate Selection Criteria, for review and approval by the JSC. Upon the JSC’s determination that any Compound satisfies the applicable Development Candidate Selection Criteria, such Compound shall be deemed the Development Candidate for all purposes hereunder.
Selection of Development Candidate. The JSC shall determine whether any Compound satisfies the applicable Development Candidate Selection Criteria. Upon the JSC’s determination that any Compound satisfies the applicable Development Candidate Selection Criteria, such Compound shall be deemed a Development Candidate for all purposes hereunder, with the expectation that a GLP Toxicology Study shall be commenced using such Development Candidate. In no event shall a GLP Toxicology Study for a Compound be commenced prior to the determination by the JSC that such Compound satisfies the applicable Development Candidate Selection Criteria without the prior written consent of EISAI.
Selection of Development Candidate. During the Research Term, using the candidate selection criteria set forth in the Joint Research Plan as a guide, each Party shall use Diligent Efforts to conduct studies under the Program with the goal of identifying at least one (1) RNAi Product directed to a Program Target (or, subject to Section 4.3, both Program Targets) that are suitable for advancement as a development candidate into IND-Enabling Studies under this Agreement. Within [**] days following the completion of activities under the Joint Research Plan,
(a) the Parties may mutually agree on the selection of at least one (1) RNAi Product directed to a Program Target (or both Program Targets, if applicable) as a development candidate hereunder and on a Development Plan pursuant to which the Parties shall pursue the Development of such development candidate under the Program, in which event the Program, and each Party’s rights and obligations under this Agreement, shall continue as to such RNAi Product(s) and such Program Target(s), subject to either Party’s exercise of its Opt-Out Right(s); or
(b) if the Parties are unable to mutually agree on the selection of at least one (1) development candidate hereunder, or are able to mutually agree on the selection of at least one (1) development candidate but are unable to mutually agree on a Development Plan for such development candidate, then (i) the Parties may agree to discontinue the Program, and all Discovery and Development activities hereunder, in which event this Agreement shall be terminated, subject to the Parties’ mutual agreement on the terms of any necessary wind-down, or (ii) a Party may exercise its Opt-Out Right at Candidate Selection Stage with respect to a particular RNAi Product Developed under the Program during the Research Term pursuant to Section 4.9; provided, that, if a Party has no bona fide interest in pursuing the Program or any RNAi Product Developed under the Program, such Party shall have a good faith obligation to exercise its Opt-Out Right hereunder. Notwithstanding the above, in no event shall each Party progress the same development candidate separately because of being unable to mutually agree on a Development Plan for such development candidate.
Selection of Development Candidate. Following completion of the studies described in Section 4.2, the Joint Development Committee shall apply the Selection Criteria to determine whether the studies referenced in Section 4.2 generated results sufficient to allow selection of a Development Candidate. In the event that the Joint Development Committee determines that additional studies are required to reach a decision, then the Joint Development Committee shall order additional studies, which will be shared equally by the parties. In the event that Joint Development Committee determines that it has sufficient information to enable selection of a Development Candidate, the President of Cypress and the Vice President, Research of Organon shall apply the Selection Criteria to determine which Development Candidate to take into further Clinical Trials based on the Selection Criteria within 30 days of presentation to the Joint Development Committee of the results of such studies (and any other information the Joint Development Committee determines to be necessary to make such decision).
(a) First Level of Resolution. If such determination is not made pursuant to the preceding paragraph within such [...***...] the Joint Development Committee shall provide written notice thereof to Cypress and Organon no later than the end of such [...***...] period (“First Notice”), referring such determination to a senior scientific officer of Cypress, and a senior research manager of Organon. Such representatives shall meet and make a final determination with respect to Development Candidate selection as soon as reasonably practicable, and in no event more than [...***...] of receipt of the First Notice.
(b) Second Level of Resolution. If such representatives are not able to make such determination within such [...***...] period following the First Notice, they shall provide written notice thereof to Cypress and Organon no later than the end of such [...***...] period (the “Second Notice”), referring such determination to an Organon executive officer more senior than the preceding Section and the Chief Executive Officer of Cypress. Such executive officers shall meet and make a final determination with respect to Development Candidate selection within [...***...] of receipt of the Second Notice; provided, however, that [...***...] then the determination made by the senior executive officer of Organon shall be deemed the final determination with respect to the Development Candidate selection.
Selection of Development Candidate. On an Available Target-by-Available Target or Selected Target-by-Selected Target basis, as applicable, the JRC shall, in good faith, determine whether or not a Compound satisfies the applicable Development Candidate Selection Criteria; provided that [**]. Upon the earlier of: (i) determination that any Compound satisfies the applicable Development Candidate Selection Criteria pursuant to the preceding sentence, or (ii) the effectiveness of an IND with respect to a Compound, such Compound shall be deemed a Development Candidate for all purposes hereunder. On an Available Target-by-Available Target or Selected Target-by-Selected Target basis, as applicable, once an applicable Compound has met the Development Candidate Selection Criteria or has been deemed to be a Development Candidate, subject to Sections 2.4 and 2.5, EPIZYME may, in its sole discretion, develop a plan for conducting a Phase 1 Clinical Trial for such Development Candidate and such Available Target or Selected Target, as applicable, and shall retain final decision-making authority related thereto, subject to CELGENE’s right to review and provide comments on the protocol related to such trial, which comments EPIZYME shall consider in good faith; provided that, if EPIZYME determines not to proceed with developing such a plan and conducting such a Phase 1 Clinical Trial, such determination shall promptly be noticed by EPIZYME to CELGENE in writing and thereupon EPIZYME shall be deemed to have exercised an EPIZYME Pre-IND Opt-Out as to such Available Target pursuant to Section 2.4.
