Development Candidate Selection Criteria definition
Examples of Development Candidate Selection Criteria in a sentence
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.
For purposes of clarity, except as otherwise set forth in a Joint Development and Commercialization Agreement with respect to a Shared Product, EPIZYME shall not be obligated to conduct Development activities beyond those contemplated under the Research and Development Plan, regardless of whether any Compound identified or Developed under the Collaboration fails to meet the applicable Lead Candidate Criteria or Development Candidate Selection Criteria and regardless of whether Proof of Concept is achieved.
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.
The JSC shall determine whether any 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.
Following the Effective Date and during the Research Term, the Parties shall mutually agree on any additional Development activities to be performed by the Parties beyond those necessary for the Current Lead Series to attain the Development Candidate Selection Criteria, which Development activities shall be included in the Research and Development Plan.
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.
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; [**].
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.
Within [**] days after the Effective Date, the Parties will establish a Subcommittee under the JDC for Manufacturing (including CMC) related matters, which shall initially be with respect to DOT1L (and thereafter, with respect to each Selected Target at the time a Compound Directed to such Selected Target meets the Development Candidate Selection Criteria pursuant to Section 2.2.5) (the “Manufacturing Subcommittee”).