Proof of Concept Study definition

Proof of Concept Study means a Phase 2 Clinical Trial that is appropriately designed (i) to demonstrate efficacy in the disease to be studied through relevant primary and/or secondary efficacy endpoints as described in the Proof of Concept Development Plan and (ii) to allow dose selection and support generation of efficacy data that would allow movement of the product into a Phase 3 Clinical Trial that would support the regulatory strategy of seeking Regulatory Approval in both the AVEO Territory and the EU. For purpose of clarity, a clinical study meeting the requirements of this definition will be considered a Proof of Concept Study when completed whether or not the endpoints of the study are actually met.

Proof of Concept Study. Proof of Concept Study means a Phase II Clinical Trial, the design of which is intended to demonstrate achievement of a primary efficacy endpoint as established by the Parties and approved by the JSC in a clinical trial filed with, and permitted to proceed by, the applicable Regulatory Authority.

Proof of Concept Study means a human clinical trial for a particular Phase I Ready Compound that meets the requirements of 21 C.F.R. Section 312.21(b) and is intended to explore [ * ].

Examples of Proof of Concept Study in a sentence

• During the Option Exercise Period, AVEO shall have sole responsibility for Development and Manufacture of Licensed Product, at AVEO’s sole cost and expense, and AVEO shall use Commercially Reasonable Efforts to perform its Development activities as contemplated under the Proof of Concept Development Plan and to Develop Licensed Product through completion of the first Proof of Concept Study.

• If and to the extent requested by Biogen Idec, appropriate members of the clinical development and regulatory teams of AVEO shall meet with appropriate members of the clinical development and regulatory teams of Biogen Idec to discuss the Proof of Concept Study, including the design thereof as well as the Licensed Product and indication being studied in the Proof of Concept Study, and the Development activities and timelines contemplated under the Proof of Concept Development Plan.

• AVEO shall deliver the Data Package from the first Proof of Concept Study to Biogen Idec and an initial Development Plan no later than [**] after the last visit of the last patient to be dosed in such Proof of Concept Study.

• For purposes of this Section 13.1, (x) any reference in the definition of “Proof of Concept Study” to the Proof of Concept Development Plan shall be deemed to be a reference to the Delivered Initial Development Plan provided pursuant to this Section 13.1, and (y) any reference in the definition of “Pre-Phase 3 Manufacturing Costs” to the Option Exercise Date shall be deemed to be a reference to the date of the completion of the Proof of Concept Study.

More Definitions of Proof of Concept Study

Proof of Concept Study or “POC Study” means a human clinical trial of a Compound or Product conducted by Ultragenyx or any Affiliate to demonstrate preliminary clinical safety and efficacy with a small number of strictly selected patients.

Proof of Concept Study means, with respect to each Development Product or Substitute Product (if applicable), a Phase I study rolling over into a Phase II study which includes a safety evaluation component (Phase I) designed to determine a safe and practical dose for further evaluation of the Development Product or Substitute Product (if applicable), and an efficacy evaluation component (Phase II) in which patients are evaluated for evidence of clinical activity of the Development Product or Substitute Product (if applicable) administered at a safe and practical dose. This Phase I study rolling over into a Phase II study shall include sufficient eligible patients as outlined in an IND submitted to Regulatory Authorities in writing. This Phase I study rolling over into a Phase II study will be conducted in approximately twenty-five (25) to thirty (30) evaluable patients.

Proof of Concept Study means an open label, repeat dose, dose escalation clinical study of a Product in adult humans with short bowel syndrome.

Proof of Concept Study means a Phase II Clinical Trial that is appropriately designed to: (a) demonstrate efficacy in the disease to be studied through relevant primary and/or secondary efficacy endpoints as described in a development plan for such trial; and (b) allow dose selection and support generation of efficacy data that would allow movement of the product into a Phase III Clinical Trial that would support seeking Governmental Approval in any country in the Territory.

Proof of Concept Study means [* * *].

Proof of Concept Study means a Phase I /IIa Clinical Study.

Proof of Concept Study has the meaning set forth in Section 5.1.2.