Collaboration Development Candidate definition

Collaboration Development Candidate means the SNA that has achieved Stage 2, together with its backup compounds (if any), under the Collaboration Research Plan and intended for further Development and Commercialization to modulate, including decreasing or increasing, expression or activity of a Collaboration Target in the Field.
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Examples of Collaboration Development Candidate in a sentence

  • The time and cost of the Development activities under this Stage will be tailored to the Collaboration Development Candidate and Indication.

  • In a nutshell, the Kyoto accounting rules focus on forestry land-use changes since 1990, the chosen base year for the agreement.

  • For each Stage, certain defined success criteria, which must be mutually-agreed in writing prior to the commencement of any work on any Collaboration Development Candidate or Collaboration Product, must be met in Licensee’s reasonable and sole discretion before proceeding to the next Stage.

  • Sanofi will have the right, in its sole discretion, to designate any Small Molecule(s) arising out of a Research Plan as a Collaboration Development Candidate, irrespective of whether such Small Molecule meets [***].

  • Without limiting Sanofi’s rights under Clauses 4.4 or 32.4, if Sanofi does not designate any Collaboration Development Candidate for an Approved Collaboration Target within [***] days following the delivery of the final complete Development Candidate Data Package (other than if agreed by EXS), then this Agreement with respect to that Approved Collaboration Target will be deemed to have been terminated by Sanofi under Clause 32.2 and such Approved Collaboration Target will be deemed a Terminated Target.

  • The Collaboration Target of such Collaboration Development Candidate is: _____________________________________.

  • ADDITIONAL REASONS FOR DENIAL OF LICENSE AND LIMITATIONS ON LICENSE.

Related to Collaboration Development Candidate

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

  • 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.

  • 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.

  • Licensed Compound means [***].

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

  • Development Program means the implementation of the development plan.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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).

  • Research Program has the meaning set forth in Section 2.1.

  • Research Program Term has the meaning set forth in Section 2.2.

  • 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 III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

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

  • 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).

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Research Plan shall have the meaning set forth in Section 2.1.

  • 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.

  • Collaboration has the meaning set forth in Section 2.1.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • 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 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 Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.