Proof of Concept Criteria. Prior to the initiation of the first applicable Clinical Trial for a Collaboration Program, the Parties shall through the JSC agree upon the provisional Proof of Concept Criteria for each Collaboration Program, and prior to entering into the relevant Study, the Parties shall agree on the final criteria, subject to GSK’s right to have the final say on the matter under Section 3.2(d).
Proof of Concept Criteria. Prior to the initiation of the first applicable [ * ] for a Program, [ * ] shall establish the provisional clinical trial design, including planned [ * ], for the Proof of Concept Study, and shall [ * ], collectively, as the Proof of Concept Criteria, prior to initiation of the PoC Study. All such Proof of Concept Criteria shall be established reasonably in accordance with the guidelines and examples attached hereto as Exhibit D.
Proof of Concept Criteria. Upon the completion of any Proof of Concept Study, Dynavax shall promptly notify GSK in writing of such event and shall provide to the JSC a complete data package containing all analyses, results and raw data from the completion of the Proof of Concept Study for such Phase I Ready Compound, and any related correspondence and information received from or sent to any Regulatory Authority relating to such Phase I Ready Compound (the “PoC Study Report”). GSK shall have the right to exercise its Option to such Dynavax Program upon the completion of the Proof of Concept Study pursuant to Section 4.1 (whether or not such criteria have been satisfied). Unless otherwise agreed by the Parties, if requested by GSK, the JSC will schedule an ad hoc meeting not more than [ * ] Calendar Days after receipt of any such PoC Study Report to review such PoC Study Report and confirm whether or not such Phase I Ready Compound satisfies the Proof of Concept Criteria. If the JSC [ * ] decides that the Phase I Ready Compound did not satisfy the Proof of Concept Criteria, then, except as provided in Section 5.3, Dynavax will [ * ] with respect to such Dynavax Program, and GSK may, [ * ]. In the event that the Compound fails to satisfy the Proof of Concept Criteria after completion of the Proof of Concept Study, [ * ] which completed the PoC Study, in such case the [ * ] and all other [ * ] for such GSK Development Program shall all be [ * ] from the [ * ] otherwise applicable, and the applicable [ * ]. If at any time after Option exercise the Compound that completed the PoC Study [ * ], as applicable, then GSK shall [ * ].
Proof of Concept Criteria. Prior to the initiation of the first applicable Clinical Trial for a PROSENSA Collaboration Program, the Parties shall through the JSC agree upon the provisional Proof of Concept Criteria for each PROSENSA Collaboration Program and prior to entering into the relevant Study the Parties shall agree on the final criteria, subject to Section 3.1(d). For the avoidance of doubt, the Parties acknowledge that the POC Criteria with respect to the Exon 44 Program are established and agreed as set forth on Exhibit C. In addition the general guidelines for non-clinical criteria are set forth in Exhibit C.
