DC Data Package definition

DC Data Package has the meaning set forth in Section 3.3.2 (DC Data Package).
View Source
DC Data Package has the meaning set forth in Section 2.3.1 (Research Plans—In General).
View Source
DC Data Package means a collection of all then-available information, data, and results arising from the completion of such activities by Fate for such DC Collaboration Candidates so that a determination may be made as to whether any of such DC Collaboration Candidates should be further developed in IND Enabling Studies. Any cells (including Collaboration Candidates) that are generated in the course of generating the DC Collaboration Candidates included in a particular DC Data Package, but not included in such DC Data Package, will be deemed to be “Rejected Candidates.”
View Source

Examples of DC Data Package in a sentence

  • To the extent available, the Party delivering such DC Data Package will provide the JSC with any such missing information identified in such notice no later than [***] after the date of the JSC’s request therefor.

  • Within [***] after the receipt of a DC Data Package from a Party, the JSC will notify such Party if such DC Data Package is missing any results that were to be delivered in the DC Data Package, which notice will describe in writing the information that the JSC believes to be missing.

  • If the JSC agrees that such an interim DC Data Package would be beneficial to AstraZeneca, Cellectis shall submit an interim DC Data Package to AstraZeneca consistent with parameters agreed by the JSC.

  • If the JPT believes that it would be beneficial for AstraZeneca to review an interim DC Data Package, the JPT may make such recommendation to the JSC.

  • The JPT’s recommendation shall contain a high-level overview of the contents of such interim DC Data Package, timing of its delivery, and any other relevant parameters.

  • If, at the time of the Exercise Effective Date for the Licensed Collaboration Candidate, there are IND Enabling Studies being conducted for other Pre-IND Collaboration Candidates that were included in the same DC Data Package as the Licensed Collaboration Candidate, ▇▇▇▇▇▇▇ may elect [***] ▇▇▇▇▇▇▇ will decide whether to exercise the Commercial Option for any of such other Pre-IND Collaboration Candidate in accordance with Section 4.3 and for which of such candidates IND applications should be prepared.

  • For each Research Program with respect to a ▇▇▇▇▇▇▇ Antigen, the Research Plan shall describe the contents of the DC Data Package and IND Data Package for such Research Program.

  • During the Research Term, if Cellectis reasonably believes that it has developed a Candidate Product which satisfies the applicable Development Candidate Criteria, then Cellectis shall submit the DC Data Package to the JSC, together with a draft of Schedule 12.3 which sets forth any information solely to the extent necessary to make Cellectis’s representations and warranties set forth in Schedule 12.3 true and correct as of such date with respect to the Candidate Product.

  • Within [***] after the receipt of a DC Data Package (including, for clarity, any interim DC Data Package described in Section 2.5.2 (DC Data Package) or Section 2.5.3 (Research Plan Duration Data Package)), AstraZeneca will, following discussions at the JSC, notify Cellectis if AstraZeneca reasonably believes that such DC Data Package is missing any required information included in the Research Plan, which notice will describe such information that AstraZeneca reasonably believes to be missing.

  • To the extent required to be included in any DC Data Package, Cellectis will provide the JSC with any such missing information identified in such notice no later than [***] after the date of AstraZeneca’s request therefor (the DC Data Package, including any required information subsequently provided by Cellectis as contemplated by this Section 2.5.4 (Final DC Data Package), the “Final DC Data Package”).

Related to DC Data Package

  • Data Package has the meaning set forth in Section 2.9(a).

  • 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. [***]

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.