IND Enabling Activities definition

IND Enabling Activities means, with respect to a particular Research Product, all Development activities required (including the compilation of data resulting therefrom (including CMC Data) in a form suitable) to support the filing of an effective IND with FDA (e.g., that would not be subject to a clinical hold within thirty (30) days of filing) sufficient to conduct human clinical trials for such Research Product in the United States.
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IND Enabling Activities shall have the meaning set forth in Section 2.1.2.
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IND Enabling Activities means, the pre-clinical research and development activities intended to enable the submission of an IND, including a toxicology study that satisfies applicable regulatory requirements, using applicable GLP that meets the standard necessary for submission as part of an IND with the applicable Regulatory Authority.
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Examples of IND Enabling Activities in a sentence

  • The principle objective of the activities under the Research Plan is for Morphic to generate and Develop Research Products Directed to each Research Target, including performing IND Enabling Activities for at least [***] Research Product Directed to each such Research Target that meets the Advancement Criteria for an Indication other than a Liver Fibrosis Indication and generating at least [***] Backup Research Product Directed to each such Research Target.

Related to IND Enabling Activities

  • Competing Activities means the same or similar services as ▇▇▇▇▇▇ ▇▇▇ Ltd is providing to the Restaurant under this Agreement or other activities having a similar purpose.

  • Interfering Activities means (A) encouraging, soliciting, or inducing, or in any manner attempting to encourage, solicit, or induce, any Person employed by, or providing consulting services to, any member of the Company Group to terminate such Person’s employment or services (or in the case of a consultant, materially reducing such services) with the Company Group; (B) hiring any individual who was employed by the Company Group within the six (6) month period prior to the date of such hiring; or (C) encouraging, soliciting, or inducing, or in any manner attempting to encourage, solicit, or induce, any Business Relation to cease doing business with or reduce the amount of business conducted with the Company Group, or in any way interfering with the relationship between any such Business Relation and the Company Group.

  • Motorcycling Activities means performing or participating in any capacity in any authorised or recognised Motorcycling Organisation event, meeting or activity;

  • Activities has the meaning specified in Section 7.02(b).

  • Collaboration Activities means the activities set out in this Agreement