Lead Candidate definition

Lead Candidate means [***].

Lead Candidate means, with respect to a given Program, any Collaboration Candidate that Targets the Collaboration Target under such Program that (i) satisfies the Lead Candidate Criteria, or (ii) if no Collaboration Candidate has satisfied the Lead Candidate Criteria at the time when Celgene exercises its IND Option for a given Program, the Collaboration Candidate under such Program that is at the most advanced stage of Development under such Program. It is understood and agreed that a “Development Candidate” shall remain included in the definition of “Lead Candidate”.

Lead Candidate means a Regeneron Product or Intellia Liver Product, as applicable, that [***] has been selected by the respective Party for initiation of preclinical studies [***] needed to support an IND and the initiation of GMP manufacturing.

Examples of Lead Candidate in a sentence

• Each Party shall use Commercially Reasonable Efforts to perform the activities allocated to such Party under the Product R&D Plans within the timelines set forth in the Product R&D Plans and to achieve the goals and deliverables set forth in the Product R&D Plans, including using Commercially Reasonable Efforts to generate a Lead Candidate that meets the Target Profile for each Regeneron Target in accordance with the Product R&D Plans.

• During the Research Term, Prothena shall notify Celgene, on a regular basis at JSC meetings, of Collaboration Candidates identified by or on behalf of Prothena or its Affiliates in the course of its ongoing research activities pursuant to a Program that satisfies the Lead Candidate Criteria, as well as notify Celgene with respect to material developments or new data or information in Prothena’s (or its Affiliates’) possession relating to such Lead Candidates.

• Within [***] ([***]) days after Filing of the first IND with the FDA for a Lead Candidate from a given Program ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the IND Data Package for such Program (which, for clarity, shall specify all then-existing Lead Candidates from such Program).

• The Parties shall discuss in good faith for a period of [***] ([***]) days whether or not such Collaboration Candidate satisfies the Lead Candidate Criteria.

• The Lead Candidate Criteria for each Collaboration Target may be amended from time to time by the JSC.

More Definitions of Lead Candidate

Lead Candidate means, with respect to a particular Available Target, a Compound Directed to such Available Target that is selected by the JRC pursuant to Section 2.2.4 as meeting the applicable Lead Candidate Criteria, or is otherwise designated a Lead Candidate pursuant to Section 2.2.4.

Lead Candidate means a Dynavax ISS or Collaboration ISS that, in accordance with the Joint Research Plan, has been [ * ] at the time of its Lead Candidate Development Decision for further preclinical evaluation.

Lead Candidate means a Hit constituting a Structurally Enabled Hit or developed or derived from such a Structurally Enabled Hit or Target Structural Information which has been declared a lead candidate by Lilly in accordance with Lilly’s normal internal processes for lead declaration as such processes exist from time to time, including receipt of formal approval from appropriate internal review and approval committees.

Lead Candidate means those Compounds that have been [*****] CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. [*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL –

Lead Candidate means up to ten (10) Paratek Compounds that are listed on the Lead Candidate List attached hereto as Schedule 1, as amended from time to time.

Lead Candidate means any Licensed Compound that satisfies the Lead Candidate Criteria, as defined by the Advisory Committee, and/or is designated as a Lead Candidate by the Advisory Committee pursuant to Section 4.2, and/or for which Ohm commences IND-enabling toxicology studies in compliance with GLP.

Lead Candidate means: (a) a Collaboration Compound that (i) [***], or (ii) [***]; or (b) any [***].