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 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.

Examples of Development Candidate Criteria in a sentence

• 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.

• The parties will use good faith efforts through their respective representatives on the JRC to agree on any such additional Development Candidate Criteria as soon as practicable after a change is proposed to the JRC by either party.

• 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.

• The “Referral Matter” shall consist solely of disagreements concerning whether a particular Compound has satisfied all of the applicable Development Candidate Criteria.

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

More Definitions of Development Candidate Criteria

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.

Development Candidate Criteria means, on a Selected Target-by-Selected Target basis, those specific development candidate criteria set out in the relevant Research Plan, which in each case shall be consistent with the criteria set out in the general form of Research Plan attached hereto as Schedule 1.116.

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 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 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, collectively, with respect to each New Target, the criteria that will inform [***] whether a lead Arcus Molecule in the applicable New Target Program will be [***], which criteria are set forth in the New Target R&D Plan for the New Target Program for such New Target. As of the Amendment No. 2 Execution Date, the Development Candidate Criteria for each of the Initial New Targets are as set forth on Exhibit A to this Amendment No. 2.