Achievement of Development Candidate definition

Achievement of Development Candidate means the first to occur of: (a) nomination by Spyre’s Board of Directors of a Spyre Product as a “Development Candidate”; and (b) the initiation by or on behalf of Spyre or its Affiliate or Sublicensee of a toxicology study with respect to a Spyre Product that employs applicable then-current good laboratory practice standards, the results of which are intended to be submitted as part of an IND.
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Achievement of Development Candidate means the first to occur of: (a) nomination by Xxxx’s Board of Directors of a Licensed Antibody, Derived Antibody or Jade Multispecific Antibody as a “Development Candidate”; and (b) the initiation by or on behalf of Xxxx or its Affiliate or Sublicensee of a toxicology study with respect to a Licensed Antibody, Derived Antibody or Jade Multispecific Antibody that employs applicable then-current good laboratory practice standards, the results of which are intended to be submitted as part of an IND.
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Examples of Achievement of Development Candidate in a sentence

  • The reports shall also contain sufficient detail to enable Recursion to assess whether Achievement of Development Candidate Criteria has occurred with respect to any Licensed Project Compound or Derivative or any Product is otherwise selected as a Development Candidate.

  • Milestones for Enabled Compounds (including for Achievement of Development Candidate Criteria) to be negotiated prior to execution of the license agreement, [***].

Related to Achievement of Development Candidate

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

  • 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.

  • Research Program has the meaning set forth in Section 3.1.

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

  • 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 I Clinical Trial means for the purpose of obtaining Regulatory Approval a study in humans the purpose of which is preliminary determination of safety of a Product in healthy individuals or patients that would satisfy the requirements of 21 C.F.R. 312.21(a), or the equivalent process in other countries or groups of countries of the Territory.