Early Candidate Nomination definition

Early Candidate Nomination means a Compound or Product that has been approved by BMS [***].
Sample 1Sample 2
Early Candidate Nomination means a Compound or Product that has been approved by BMS, in its sole discretion and pursuant to its internal governance procedures, to transition from a lead compound in a research program to exploratory development. For such a transition to be considered, the relevant scientific submissions for such Compound or Product shall generally include: (a) evidence of efficacy in multiple in vivo models; (b) evidence that toxicity is defined and is anticipated to be manageable; (c) typically, dosing the compound in [***] to establish dose limiting toxicity and a preliminary therapeutic index (d) assessment of cardiovascular risk by telemetry study in [***] to determine potential liabilities of the compound (e) the identification of potential biomarkers to assess target engagement, efficacy and toxicity; and (f) acceptable absorption, distribution, metabolism, and excretion (“ADME”) and pharmaceutics properties, including projected human dose, proposed route and frequency of administration. Typically, the Compound or Product form shall also be identified and deemed suitable for formulation.
Sample 1Sample 2
Early Candidate Nomination means documentation within which an Active Compound is nominated for clinical development by BMS pursuant to technical criteria established by the JMSC upon selection of the Target against which such a compound is active, or as soon thereafter as practical, and pursuant to the then-applicable internal policies and procedures of BMS.
Sample 1Sample 2

Examples of Early Candidate Nomination in a sentence

  • The criteria established by the Joint Management Committee for the selection of Development Candidates shall be consistent with the internal standards and criteria customarily used by BMS to qualify compounds as an Early Candidate Nomination.


More Definitions of Early Candidate Nomination

Early Candidate Nomination means a compound or other substance that has been approved by BMS [ * ]. This decision point is known within BMS as “Decision Point 3.0” or “DP3.0”. This decision point is typically made [ * ] prior to [ * ]. For such a transition to be considered, the relevant scientific submissions for such compound shall generally need to include: [ * ]. For clarity, not all [ * ] shall be necessarily completed at DP3.0; however, all such [ * ] must be completed before a decision to [ * ] can be reached. Typically, the [ * ] shall also be [ * ].
Sample 1
Early Candidate Nomination means a compound or other substance that has been approved [*] to transition from [*] in a [*] to [*].
Sample 1

Related to Early Candidate Nomination

  • Over-Riding Nomination Criteria means the criteria set out in clause 4.2.

  • Nomination Criteria means the criteria made up of the Over-Riding Nomination Criteria andthe Specific Nomination Factors, and is also referred to as “this Criteria”.

  • Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Specific Nomination Factors means the nomination factors set out in clause 4.3.

  • Nomination Period means a period of time that Customer includes in a nomination for gas service.

  • continuing candidate means any candidate not deemed to be elected, and not excluded,

  • Nominated Athlete means an Athlete who has been nominated to the NZOC by Swimming New Zealand.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Election cycle means the period beginning on the first day persons are eligible to

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Relevant Nominating Body means, in respect of a benchmark or screen rate (as applicable):

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Valid write-in candidate means a candidate who has qualified as a write-in

  • Independent candidate means any candidate who claims not to be affiliated with a political party, and whose name has been certified on the office-type ballot at a general or special election through the filing of a statement of candidacy and nominating petition, as prescribed in section 3513.257 of the Revised Code.

  • Nomination means a request by a Shipper to Carrier to transport a stated quantity of Crude Petroleum on the Pipeline for the account of such Shipper in any month.

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Nomination Notice means all information and documents that a Nominating Stockholder is required to submit to the Secretary of the Corporation pursuant to Section 1.13(f).

  • Candidate Committee means a committee established by a candidate pursuant to N.J.S.A. 19:44A-9(a), for the purpose of receiving contributions and making expenditures.

  • Annual Enrollment Period or "Enrollment Period" means the period before each policy anniversary so designated by the Sponsor and Lincoln during which you may enroll for coverage under this policy.

  • Nomination Committee means the nomination committee of the Board established in accordance with Article 114;

  • Investor Nominee has the meaning set forth in Section 2.01(a).

  • Nomination Date means the twentieth (20th) day of the month preceding the Operating Month.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;