Pre-Clinical Candidate definition

Pre-Clinical Candidate means a preparation containing an ADDL Antibody or ADDL Antigen for which Merck has commenced dosing of the first animal in a study under conditions meeting Good Laboratory Practices, where such study is intended to support an IND filing.

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Pre-Clinical Candidate means any compound that is nominated by the !CR as a pre- clinical candidate, considering the Pre-Clinical Candidate Criteria, and is approved by the JSC as a “Pre-Clinical Candidate”.

Pre-Clinical Candidate or “PCC” means any Program Compound that is approved by Merck in its sole discretion as a PCC in accordance with Section 2.6.

Examples of Pre-Clinical Candidate in a sentence

Without limiting the provisions of this Section 3.6(a), BeiGene will have the right at any time, in its sole discretion, to designate in writing [***] Compounds under a given Research Program to be Pre-Clinical Candidate(s) from such Research Program, and in such case, such Compounds will be classified as “Pre-Clinical Candidate(s)” for such Research Program even if such Compounds did not satisfy the Pre-Clinical Candidate Criteria.
On a Research Program-by-Research Program basis, from and after the Pre-Clinical Candidate Attainment Date for such Research Program, the JRC shall not have any further decision making authority with respect to such Research Program and all subsequent decisions regarding the further Research, Development, manufacture and Commercialization of the applicable Compounds and associated Products for such Research Program shall be at BeiGene’s sole discretion, subject to the terms of this Agreement.
On a Research Program-by-Research Program basis, after the Pre-Clinical Candidate Attainment Date for such Research Program, BeiGene shall have the right to further Research, Develop, manufacture and Commercialize all Compounds and associated Products from such Research Program as a Licensed Program.
If Teva elects not to file a patent application claiming a Pre-Clinical Candidate, Teva’s Patent Lead shall promptly notify CRT’s Patent Lead of such decision and CRT shall have the right (but not the obligation) to file such an application.
Upon ArriVent’s payment of the third installment of the Research cost for a Pre-Clinical Candidate under Article 4.3.2 and the approval by JSC of a Compound, the License granted by Alphamab to ArriVent under Article 2.1 shall become effective with respect to such Compound.
For the avoidance of doubt, the Late Research Program Term shall end on the date that Merck provides notice to Company regarding the nomination of a Pre-Clinical Candidate, whether or not such term is extended under this Section 2.9.4.
On a Licensed Program-by-Licensed Program basis, promptly following the Pre-Clinical Candidate Attainment Date for the first Pre-Clinical Candidate from such Licensed Program, Ambrx will prepare and provide to BeiGene a draft plan for the transition of the Research, Development and manufacture of all applicable Compounds and Products from such Licensed Program from Ambrx to BeiGene or its designee (a “Transition Plan”).
The right of Merck to extend the Late Research Program Term in accordance with this Section 2.9.4 shall exist as long as Merck is using Commercially Reasonable Efforts to develop at least one (1) Product Candidate and is progressing toward selection of a Pre-Clinical Candidate.
Alphamab will not proceed to perform the process development and pre-clinical material (GLP) manufacturing related Research activities to identify a Pre-Clinical Candidate until the full receipt of such second installment.
On a Licensed Program-by-Licensed Program basis, commencing as of the Pre-Clinical Candidate Attainment Date for a Pre-Clinical Candidate for such Licensed Program and continuing for the remainder of the Term of this Agreement for such Program.

More Definitions of Pre-Clinical Candidate

Pre-Clinical Candidate or “PCC” shall mean a Product Candidate for which the authorized committee at Merck has authorized commencement of dosing of the first animal in a study under conditions meeting or intended to meet Good Laboratory Practices, where such study is intended to support the filing of an IND.

Pre-Clinical Candidate means a Licensed ADC Directed to SEZ6 or MUC16 [***].

Pre-Clinical Candidate means, on a Research Program-by-Research Program basis, (a) a Compound for a given Research Program that meets or exceeds the PCC Criteria, as reasonably determined by the JRC, or (b) a Compound from a given Research Program that BeiGene selects for inclusion in GLP Toxicology Studies.

Pre-Clinical Candidate has the meaning given in the RCOA. For clarity, certain Pre-Clinical Candidates identified prior to the Effective Date have been listed in Schedule 3 Part A which may be updated from time to time in accordance with Clause 7.13;

Pre-Clinical Candidate or “PCC” shall mean (a) each Initial Compound that meets the Initial PCC Requirements that is selected by the Joint Steering Committee in accordance with Section 3.2 and developed under the Development Plan; and (b) the Reload Compound (if any) that meets the Initial PCC Requirements and the further criteria set by the unanimous decision of Joint Steering Committee without invoking casting vote of its chairperson under Section 3.4.2, in each case to start the Development activities under Section 3.2 to enable IND filing by the Parties in their respective territories, including for completion of the Scientific Development by Ambrx and the subsequent Pre-Clinical Development by Sino in scale-up production, process optimization and other Development activities in regulatory aspects for Successful Dual IND Filing with Regulatory Authority.

Pre-Clinical Candidate means preclinical candidate nomination, which is deemed to be achieved as soon as the success criteria set forth in Exhibits 3.1.2(a)1-7 are achieved.