Significant Activity definition

Significant Activity means any activity, including but not limited to, the following activities which may have a major effect or substantial impact on the area for which an application has been filed or on another part of an inland wetland or watercourse system:

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Significant Activity means any of the following in relation to a Collaboration Compound, Collaboration Product, Licensed Compound or Licensed Product: (a) […***…]; (b) […***…] (c) […***…]; (d) […***…]; (e) […***…]; (f) […***…]; (g) […***…]; and (h) […***…]. Notwithstanding the foregoing, any activities set forth in (a) through (h) above, that normally would be related to an earlier phase of development and/or commercialization, shall not be considered Significant Activity once development of the applicable Collaboration Compound, Collaboration Product, Licensed Compound or Licensed Product has progressed beyond such earlier phase for a particular indication, as evidenced by the performance of any activity that normally would be considered to be related to any later phase for such indication, provided always that to the extent that a Party can reasonably demonstrate that activities relating to an earlier phase of development are reasonably necessary, then such activities shall be considered Significant Activity.

Significant Activity means any activity, including, but not limited to, the following activities which may have a major effect or significant impact:

Examples of Significant Activity in a sentence

• For purposes of Article IV, Ambit shall be deemed to be engaging in Significant Activity with respect to a Licensed Compound if it is engaging Significant Activity with respect to any one (1) of the Option Compound or its Backup Compounds.

• In the event that Fellows and Houston jointly acquire an Acquired Project, then the definitions of Significant Activity and Area of Mutual Interest, as required under a Formal Presentation, shall be mutually agreed to by Fellows, Houston and ▇▇▇▇▇▇▇▇▇.

• The Work Plan will: (i) describe all relevant elements of [***] for the selected CD and shall [***]; (ii) include the conduct of Significant Activity at least [***]; and (iii) [***].

• The Work Plan relating to the Final Development of the Product shall include the conduct of Significant Activity [***].

• Cephalon shall be deemed to be in compliance with this Section 4.3(a) for a Verified Compound if Cephalon is exercising Significant Activity in relation to the Verified Compound or Product, as applicable.

More Definitions of Significant Activity

Significant Activity means any of the following in relation to a Pre-Clinical Candidate or Licensed Product:

Significant Activity means an activity described in the first column of Schedule 4 that is identified in the second column of Schedule 4 [of the agreement] as 'Significant'.

Significant Activity means any activity, including, but not limited to, the following activities which may have a major effect or significant impact on the area for which an application has been filed or on another part of the inland wetlands or watercourses system:

Significant Activity means [***].

Significant Activity means any activity, including but not limited to the following activities that may have a major effect or significant impact on a wetland or watercourse:

Significant Activity means any activity, including, but not limited to, the following activities which may have a major effect or significant impact on wetlands or watercourses:

Significant Activity means any of the following in relation to a Verified Compound or Product: (a) significant research activity related to a Verified Compound or Product or related to biological processes that a Verified Compound or Product would or could affect, including, but not limited to, animal studies; (b) active preclinical work required for a planned clinical trial, including toxicology or pharmacokinetic work; (c) active planning of a clinical trial (or in the event of issues arising with a regulatory agency in relation to a clinical trial, active negotiation with the regulatory agency and/or replanning of the clinical trial); (d) actively seeking to obtain the necessary IND or IRB/ethics committee or other approvals to carry out a clinical trial; (e) active enrollment of patients into, or participation of patients in, a clinical trial, where relevant in accordance with the protocol in order to determine if the primary end point has been met; (f) active monitoring, analysis or reporting on the data arising from a clinical trial where relevant in accordance with the protocol in order to determine if the primary end point has been met; (g) manufacture or formulation of a Verified Compound or Product for use in a clinical trial, including active process development work in support of planned manufacture; and (h) preparation for and making submissions to regulatory agencies for an NDA or awaiting the outcome of such submission.