Development Candidate Criteria definition

Development Candidate Criteria means the criteria set forth in Schedule 1.14 hereto which shall be applicable to any Compound selected by Vertex as a Development Candidate hereunder.

Development Candidate Criteria means key data regarding the developability characteristics of a Collaboration Compound candidate for nomination as a Development Candidate for IND enabling studies. Typically the developability criteria will include data regarding [***] of the Collaboration Compound and other pharmacokinetic parameters of the Collaboration Compound in [***] as well as a preliminary assessment of the risk of [***], as well as evaluation of [***]. An assessment of toxicokinetics and selection of GLP toxicity species should be typically included with preliminary repeat dose toxicity in [***], genotoxicity (Xxxx test), and cardiac (hERG) safety. In addition, the properties of the Collaboration Compound regarding purity, solution and solid state stability and physicochemical properties should be included. Assessment of the consistency of the chemical form, scalability of synthetic routes and availability of starting materials will also be typically included in the assessment.

Development Candidate Criteria means the decision criteria for a Project Compound to be considered as a Development Candidate as set forth on a Project-by-Project basis in the respective Project Plan.

Examples of Development Candidate Criteria in a sentence

• The JRC will notify Merck each time a Compound meets the Development Candidate Criteria.

• As soon as Vertex has identified a Development Candidate which it believes meets the Development Candidate Criteria, it will so notify CFFT and the JRC and will include with that notice the Development Candidate Information with respect to that Development Candidate and its Back-up Compounds.

• In collaboration with NT’s Chedworth Roman Villa such a dome system has been used to deliver a number of user studies to assess the domes effectiveness.

• Any disagreements with respect to the selection of additional Development Candidate Criteria hereunder will be addressed as provided in Section 2.6.2(ii).

• The parties acknowledge that it may be necessary or appropriate to adopt additional Development Candidate Criteria which more specifically define the pre-development characteristics of Compounds which the parties believe may be suitable for development and commercialization based upon the particular mode of action of that Compound as a Potentiator or Corrector.

More Definitions of Development Candidate Criteria

Development Candidate Criteria means the criteria set forth in Schedule 1.1.35.

Development Candidate Criteria means the criteria set out in Schedule 1.15, as such criteria may subsequently be revised by the Parties as an amendment to this Agreement.

Development Candidate Criteria means, for each Program, the criteria established and updated from time to time by the JSC to be met upon completion of the Development Candidate Activities to support the determination of a Development Candidate by the JSC.

Development Candidate Criteria means the criteria the JSC uses to determine whether an SRA Drug Candidate is an SRA Development Candidate and/or whether a New Compound is a New Compound Development Candidate. The Development Candidate Criteria as of the Effective Date are attached hereto as Appendix 1.18.

Development Candidate Criteria are the criteria set out in Schedule 1.15, and as such criteria may be subsequently revised by the JRC.

Development Candidate Criteria means the criteria to be achieved by any Compound during Project Phase 2 of any Collaboration Program as initially set forth in Section B of Exhibit A, which criteria may be modified for each applicable Collaboration Program by the JSC. Effective Date has the meaning set forth in the preamble;

Development Candidate Criteria means, with respect to a Collaboration Target, (a) the criteria for Degraders directed to such Collaboration Target set forth in the Candidate Development Plan as “Development Candidate Criteria” for such Collaboration Target, which criteria are intended to indicate that such Degraders are suitable for testing in IND-Enabling Studies, and (b) the IP Criteria for Degraders directed to such Collaboration Target (to the extent not set forth in the Candidate Development Plan).