POC Study definition

POC Study means a [**].

POC Study means the first human clinical trial of a Product in a particular Indication that is designed to establish clinical proof of concept for such Indication.

POC Study means a Clinical Trial of the Product for the Second Indication.

Examples of POC Study in a sentence

• Telix will provide Lilly with [**] written updates detailing the progress of activities under the Development Plan (including but not limited to the POC Study) and the results thereof.

• In addition, within [**] of completion of any pre- clinical (animal) studies set forth in the Development Plan, which is expected to occur within [**] after the Effective Date, and completion of the POC Study, respectively, Telix will provide a report detailing the results of such pre-clinical studies or POC Study, respectively, to Lilly.

• Lxxxx shall be entitled to terminate this Agreement on written notice to Telix if FPI has not occurred with respect to the POC Study by the second (2nd) anniversary of the Effective Date and is not cured within [**] following notice from Lxxxx indicating an intent to terminate for such failure.

• Neither Telix nor any Affiliate thereof shall use any Third Party contractors to perform any portion of the POC Study or use or handle any Transferred Materials except to the extent such Third Party is listed on Exhibit G attached hereto or is approved by Lxxxx in writing and in advance, which approval will not be unreasonably withheld.

• Telix shall provide Lilly a complete, detailed, written report of the results of the POC Study, and any other New Know-How or information related to any New Patents related to, in either case, the Companion Diagnostic, promptly upon the earlier of the early termination of the POC Study or the Successful Completion thereof.

More Definitions of POC Study

POC Study means a [***] Phase 1 study designed to show clinical proof of concept in a multiple-ascending-dose study.

POC Study means the first clinical trial conducted by or on behalf of Licensee for the purpose of determining the safe and effective dose range in patients for the proposed therapeutic indication of Licensed Product. For clarity, a [*], shall be deemed a POC Study for the purpose of this Agreement.

POC Study means, with respect to a Product, a Phase IIa Clinical Study that is appropriately designed (a) to demonstrate efficacy in Esophageal Squamous Cell Carcinoma (“ESCC”) through relevant primary and/or secondary efficacy endpoints as described in the POC Development Plan and (b) to support generation of efficacy data that would allow movement of such Product into a Phase IIa Clinical Study or Phase III Clinical Study that would support the regulatory strategy of seeking Regulatory Approval for ESCC in the Territory.

POC Study means a proof-of-concept clinical study to be conducted as part of the Option Period Studies.

POC Study means a study conducted during a Phase II Clinical Trial designed to give preliminary evidence of efficacy and safety for a Product.

POC Study means the proof-of-concept study described in the Development Plan, all expenses of conducting the study being the sole responsibility of Aradigm.

POC Study means a proof of concept study conducted after the IND approval for a Program where the clinical efficacy of the IND candidate is determined in at least ** patients.