Formal Preclinical Development definition

Formal Preclinical Development means the aggregate of in vitro and in vivo studies required by the US FDA to determine the potential risk a compound poses to man and the environment, necessary and sufficient for an IND approval.
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Examples of Formal Preclinical Development in a sentence

  • It is agreed, however, that the Initiating Party shall keep the other party informed of the progress of its Formal Preclinical Development by sending [ * ] summary reports with the essential data and results to enable the other party to a qualified decision.

  • For the removal of doubt, it is clarified that a Party has the right to initiate Formal Preclinical Development of the Product even if the other Party has not yet completed the Proof of Concept studies for the Product in his therapeutic category of interest.

  • The Joint Development Program shall include specifically those studies of the Formal Preclinical Development or Clinical Development studies required by each Party for their specific independent development program, and that are suitable to both Parties’ therapeutic category of interest and benefit both their Formal Preclinical Development and Clinical Development.

  • During the Development Stage of Collaboration the Parties shall determine which, if any, Formal Preclinical Development or Clinical Development studies are suitable to both Parties’ therapeutic category of interest and benefit both their Formal Preclinical Development or Clinical Development and shall cooperate with each other in the performance of such studies, in accordance with the provisions of Section 4.3 herein (the “Joint Development Program” ).

  • In the event that the Parties do not make such decision at the same time, the Development Stage shall commence when one Party notifies the other in writing that it has commenced Formal Preclinical Development of a Product following completion of Proof of Concept studies (i.e. in vitro cell culture studies) in such Party’s therapeutic area of interest (the “Development Commencement Date”).