POC Study definition

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 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 [**].

Examples of POC Study in a sentence

  • If, at Roche’s request, Pharmasset continues to hold the IND for a Product after completion of the POC Study, then Roche shall reimburse Pharmasset for its reasonable expenses incurred in connection with activities relating to holding the IND, including direct internal labor costs, which shall be reimbursed at a rate of $150 per hour.

  • The objective of each Collaboration Program is to (i) discover and Develop a Lead Vector for each Program for further Development under the terms of this Agreement and (ii) progress each Lead Vector to the completion of the POC Study.

  • Lung Rx shall have no more than thirty (30) days from delivery of the complete final report describing the results of the POC Study to determine whether the POC Study was Successful.

  • The objective of each PROSENSA Collaboration Program is to (i) discover and Develop a Lead Compound for each Program for further Development under the terms of this Agreement and (ii) progress each Lead Compound to the completion of the POC Study.

  • In addition to the foregoing transfer obligations, the Parties will take such steps as are necessary for Licensor to continue conducting the On-Going Studies and the POC Study under the IND(s) transferred to Licensee.


More Definitions of POC Study

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 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 clinical study to be conducted as part of the Option Period Studies.
POC Study. POC Study shall mean a [**] to [**] day clinical study of an Idenix HCV Product in patients infected with HCV.
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 a study conducted during a Phase II Clinical Trial designed to give preliminary evidence of efficacy and safety for a Product.
POC Study means a Clinical Trial of the Product for the Second Indication.