Lead Development Candidate definition

Lead Development Candidate means a MEANINGFULLY INVOLVED PRODUCT for which the initiation of pre-IND toxicology studies with GMP material has commenced.
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Lead Development Candidate means the first Program Compound that has been selected [***].
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Lead Development Candidate means a Development Candidate in a Program for which IND Enabling Studies have been commenced.
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Examples of Lead Development Candidate in a sentence

  • The co-chairpersons of the JSC from each of Pyxis and Alloy shall notify the Board in writing as soon as possible (and in any event within [***]) after the JSC determines that the Lead Development Candidate has met the DC Criteria.

  • If the city conducts interviews, each Proposer/Team must be represented by their team leader and other key personnel with whom the City will be directly conducting the day-to-day business of the Project.

  • If Nippon Kayaku and Signal jointly grant a license to develop and commercialize Research Lead, Development Candidate or Product to the Third Party, Nippon Kayaku and Signal shall share equally (50%/50%) all revenues arising out of such license.

  • By: By: Name: Name: Title: Title: By: Name: Title: The Program that is the subject of this Celgene Lead Co-Co Agreement (the “Celgene Co-Co Program”) is: ¨ the [ ] Program, ¨ a Celgene Program; ¨ an [***] Program; ¨ a [***] BD Program; ¨ an [***] BD Program for which [***] is the Offering Party; ¨ an [***] BD Program for which the Lead Development Candidate is a [***] and for which [***] is the Offering Party; ¨ a [***] BD Program where the Lead Development Candidate is a [***].

  • Following receipt of the Data Package for a given Research Program, the JSC shall have a period of [***] to review such Data Package to determine whether the Lead Development Candidate for such Research Program has met the DC Criteria.

  • Notwithstanding anything to the contrary in the Agreement or herein, any capital investment required to be made (consistent with the applicable Research and Development Plan or Commercialization Plan) in connection with a Research Lead, Development Candidate or Product (such as a capital investment in a manufacturing facility) are to be borne by the Party making such capital investment initially and recouped through an appropriate depreciation charge to the Joint Venture.

  • If the JSC determines that the Lead Development Candidate has met the DC Criteria, the Board shall have a period of [***] after notification of such determination to review the Data Package and confirm (or decline to confirm) whether the Lead Development Candidate has met the DC Criteria.


More Definitions of Lead Development Candidate

Lead Development Candidate has the meaning set forth in Section 1.32.
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Related to Lead Development Candidate

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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)).

  • 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.

  • 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.

  • 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.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Development Plan has the meaning set forth in Section 3.2.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Licensed Compound means [***].

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • JCC has the meaning set forth in Section 3.1.

  • Development Program means the implementation of the development plan.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.