NHP Tox Study definition

NHP Tox Study means a non-human primate toxicology study conducted pursuant to the Research Plan.
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Examples of NHP Tox Study in a sentence

  • The term of the Research Collaboration (“Research Term”) shall be the one (1)-year period after the Effective Date and may be extended (a) by mutual agreement of the Parties; or (b) automatically if an NHP Tox Study is ongoing or has been authorized in writing by the JRC, until the conclusion of such NHP Tox Study, but in the event of (b), such extension shall apply only with respect to the ADC being studied in such NHP Tox Study.

  • The Research Plan shall allocate research responsibilities between the Parties and shall set forth the details of the research activities to be conducted by each Party to make, characterize and evaluate ADCs to be generated under the Research Collaboration up to the completion of NHP Tox Study for such ADCs, together with an estimated timeline and budget therefor.

  • If, due to any disagreement between the Parties they cannot submit such joint report within [***] after completion of the NHP Tox Study, then each report shall not be submitted until resolution of such dispute.

Related to NHP Tox Study

  • Phase I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (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).

  • 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 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. [***]

  • 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.