POC Study definition

POC Study means a [***] Phase 1 study designed to show clinical proof of concept in a multiple-ascending-dose study.
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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.
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POC Study means a proof-of-concept clinical study to be conducted as part of the Option Period Studies.
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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.

  • AstraZeneca shall ensure that the [********] for the 5619 AD POC Study is true to and accurately reflects the agreed upon [********].

  • 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.

  • The Parties agree that GSK may deviate from such established POC Criteria only in the event that: (i) such deviation is required by a Regulatory Authority in the country where such POC Study will actually be performed or (ii) such deviation is the result of a recommendation or guidance of a Regulatory Authority and will not result in a delay of the progress of a Program of more * * * * *.

  • If the failure of AMT to commence the POC Study within [**] months from the Effective Date is due to factors other than lack of animals, Amgen shall have the right to terminate the Agreement by providing written notice to AMT no later than twenty (20) Business Days after receipt of the Diligence Notice.


More Definitions of POC Study

POC Study. POC Study shall mean a [**] to [**] day clinical study of an Idenix HCV Product in patients infected with HCV.
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POC Study means a study conducted during a Phase II Clinical Trial designed to give preliminary evidence of efficacy and safety for a Product.
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POC Study means a Clinical Trial of the Product for the Second Indication.
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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.
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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.
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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.
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POC Study means (a) with respect to the HBV Program, the Clinical Study of ALN-HBV02 to evaluate safety in human volunteers and [***], as further described in Schedule 1.1.99A [***]; and (b) with respect to an ID Program, a Clinical Study of an ID Licensed Product Directed to the ID Collaboration Target in such ID Program that is designed to demonstrate human safety and [***], as further described in the applicable ID Development Plan.
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