Nomination of Development Candidates and Back-Up Compounds. Using the Target Product Profile as a guide in its decision making, ChemoCentryx shall conduct all studies it determines appropriate, applying at all times its Diligent Efforts, and shall select such Collaboration Compound it determines has met the Development Candidate Criteria and is appropriate for nomination by the JSC as a Development Candidate, and shall propose to the JSC such Collaboration Compound as a Development Candidate. The JSC shall review all relevant information and study results concerning each such proposed Development Candidate, and, subject to the JSC’s unanimous approval of such selection, ChemoCentryx shall then have the right to conduct and shall conduct IND Studies and further Clinical Studies up to and through PoC Trials, pursuant to an Early Development Program for each Development Candidate and pursuant to the Early Development Plan. In the event that no proposed Development Candidate with respect to a given Collaboration Target has been approved by the JSC as described above by the end of the Research Term, the Parties shall proceed in accordance with Section 3.2.2 with respect to such Collaboration Target. Upon nomination of a Development Candidate, ChemoCentryx shall also identify two Collaboration Compounds as preliminary Back-Up Compounds to such Development Candidate. Pursuant to the Research Program, or Early Development Program, as applicable, ChemoCentryx shall (where successful) progress such Back-Up Compounds to [***] as it deems appropriate and in light of data produced from Pre-Clinical and Clinical Studies with respect to the Development Candidate. As the Research Program progresses and prior to approval by the JSC of a Development Candidate for an Early Development Program, ChemoCentryx shall review all relevant data and may from time to time choose alternative Collaboration Compounds as preliminary Back-Up Compounds in lieu of previously proposed preliminary Backup Compounds, however, once a Development Candidate has been approved for Development by the JSC (or under Section 3.2.2) under an Early Development Program, only the JSC by unanimous decision (or GSK under Section 3.2.2) shall have the authority to make the decision on selecting the final two (2) Backup Compounds for such Development Candidate, and only the JSC shall have the authority to decide whether to terminate the Development of a Development Candidate which is under an Early Development *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Program and substitute in its place one of the Back-Up Compounds; it being understood that the objective at all times during the Early Development Program is to have identified at least two (2) Back-Up Compounds to the given Development Candidate then at issue.
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Samples: Product Development and Commercialization Agreement, Product Development and Commercialization Agreement (ChemoCentryx, Inc.), Product Development and Commercialization Agreement (ChemoCentryx, Inc.)
Nomination of Development Candidates and Back-Up Compounds. Using the Target Product Profile as a guide in its decision making, ChemoCentryx shall conduct all studies it determines appropriate, applying at all times its Diligent Efforts, and shall select such Collaboration Compound it determines has met the Development Candidate Criteria and is appropriate for nomination by the JSC as a Development Candidate, and shall propose to the JSC such Collaboration Compound as a Development Candidate. The JSC shall review all relevant information and study results concerning each such proposed Development Candidate, and, subject to the JSC’s unanimous approval of such selection, ChemoCentryx shall then have the right to conduct and shall conduct IND Studies and further Clinical Studies up to and through PoC Trials, pursuant to an Early Development Program for each Development Candidate and pursuant to the Early Development Plan. In the event that no proposed Development Candidate with respect to a given Collaboration Target has been approved by the JSC as described above by the end of the Research Term, the Parties shall proceed in accordance with Section 3.2.2 with respect to such Collaboration Target. Upon nomination of a Development Candidate, ChemoCentryx shall also identify two Collaboration Compounds as preliminary Back-Up Compounds to such Development Candidate. Pursuant to the Research Program, or Early Development Program, as applicable, ChemoCentryx shall (where successful) progress such Back-Up Compounds to [***] as it deems appropriate and in light of data produced from Pre-Clinical and Clinical Studies with respect to the Development Candidate. As the Research Program progresses and prior to approval by the JSC of a Development Candidate for an Early Development Program, ChemoCentryx shall review all relevant data and may from time to time choose alternative Collaboration Compounds as preliminary Back-Up Compounds in lieu of previously proposed preliminary Backup Compounds, however, once a Development Candidate has been approved for Development by the JSC (or under Section 3.2.2) under an Early Development Program, only the JSC by unanimous decision (or GSK under Section 3.2.2) shall have the authority to make the decision on selecting the final two (2) Backup Compounds for such Development Candidate, and only the JSC shall have the authority to decide whether to terminate the Development of a Development Candidate which is under an Early Development *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Program and substitute in its place one of the Back-Up Compounds; it being understood that the objective at all times during the Early Development Program is to have identified at least two (2) Back-Up Compounds to the given Development Candidate then at issue.
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Samples: Product Development and Commercialization Agreement (ChemoCentryx, Inc.)