Clinical Proof of Concept definition

Clinical Proof of Concept means the completion of a clinical study conducted by or on behalf of Company or any of its Affiliates or Sublicensees of a Product or Process using the Hospital Patent Rights, consisting of a minimum of [***] women patients, in which the average pregnancy rate (as measured by fetal heart beat) of all women in such study is at least [***] percent ([***]%) above the average pregnancy rate via fresh embryo transfer in the most recent National SART Clinic Summary Report for the age group adjusted average, as a result of the use of such Product or Process.

Clinical Proof of Concept means the initial demonstration of clinical efficacy of an Enzyme Product in a patient population demonstrated through the conduct of a Phase 1b Clinical Trial or a Phase 2a Clinical Trial.

Clinical Proof of Concept means [***] .

Examples of Clinical Proof of Concept in a sentence

• Erasca will notify Katmai within thirty (30) days after the first achievement of Clinical Proof of Concept for any Indication (the “POC Notice”).

• Only applicable for opt-out in connection with Establishment of Clinical Proof of Concept, the Parties may agree in writing to postpone the window, within which a Party can opt-out of the Development, in order to perform an additional clinical trial.

• The Parties agree and acknowledge that the pre-defined financial terms for opt-out at Establishment of Clinical Proof of Concept will remain applicable for the agreed postponed opt-out point.

• ASLAN shall, at its sole risk and expense, undertake all activities and perform all obligations required to develop the Product to Clinical Proof of Concept in accordance with the Master Plan, which shall include the manufacture of Products for clinical trials.

• For purposes of Cxxx’x performance of the Pre- Clinical Proof of Concept Activities described in Section 2.7.1 (Third Party Interest) and Section 2.7.2 (Coya Interest), as of the Effective Date, ARScience Bio hereby grants to Coya and its Affiliates an exclusive, royalty-free license, with the right to grant sublicenses through multiple tiers (subject to Section 2.3 (Sublicensing & Subcontracting Rights)), under the ARScience Bio Technology to perform the Pre-Clinical Proof of Concept Activities.

More Definitions of Clinical Proof of Concept

Clinical Proof of Concept means the completion of a clinical study conducted by or on behalf of Company or any of its Affiliates or Sublicensees using a Product or Process, consisting of a minimum of [***] women patients, in which the average pregnancy rate (as measured by fetal heart beat) of all women in such study is at least [***] percent ([***]%) above the average pregnancy rate via fresh embryo transfer in the most recent National SART Clinic Summary Report for the age group adjusted average, as a result of the use of such Product or Process.

Clinical Proof of Concept means, with respect to a product, the date that is the earlier of (a) [***] or (b) [***].

Clinical Proof of Concept means either (a) completion of the [...***...] patient phase II study of the Compound [...***...] Acute Myelogenous Leukemia (AML) patients with a complete response rate (CR and CRp in aggregate) [...***...] AML patients of at least [...***...]% with a CR rate of at least [...***...]%; or (b) continuation of such phase II study with additional patients or Initiation of a phase III study. For the purposes of this Agreement, "CR" shall have the meaning given to it in Journal of Clinical Oncology, Vol. 21, 2003: 4642-4649: "Morphologic complete remission: A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/uL and platelets of 100,000/uL. Hemoglobin concentration or hematocrit has no bearing on remission status, although the patient must be red cell and platelet transfusion 3 ***CONFIDENTIAL TREATMENT REQUESTED independent (no red cell transfusion for 2 weeks and no platelet transfusion for 1 week). The bone marrow would have less than 5% blasts and no Auer rods. There is no requirement for bone marrow cellularity. There should be no residual evidence of extramedullary leukemia," and "CRp" means CR but with platelets of >25,000/uL and <100,000uL;

Clinical Proof of Concept means availability of human clinical data confirming that the concept of a new Indication is feasible and that further investigation is reasonably likely to be capable of Drug Approval and Commercialization; provided, such data, with respect to new Indications, shall include efficacy and safety data from a Phase 1 Study, Phase 1/2 study and/or Phase 2 Study, or, with respect to new formulations or routes of administration, shall include pharmacokinetic data from Phase 1 Studies.

Clinical Proof of Concept means availability of human clinical data confirming that the concept of a new Indication is feasible and that further investigation is reasonably likely to be capable of Drug Approval and Commercialization; provided, such data, [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. with respect to new Indications, shall include efficacy and safety data from a Xxxxx 0 Xxxxx, Xxxxx 0/0 study and/or Phase 2 Study, or, with respect to new formulations or routes of administration, shall include pharmacokinetic data from Phase 1 Studies.

Clinical Proof of Concept means Completion of clinical Phase 2 trials that support and immediately precede the initiation of a Phase 3 clinical trial program (if so required), have been carried out on sufficient numbers of patients such that it provides a preliminary determination of safety and efficacy of the Product in the target patient population over a range of doses and dose regimens and otherwise comply with the requirements of this Agreement.

Clinical Proof of Concept or "CPC" for a Zid Embodiment means: ------------------------------------ the demonstration of efficacy and adequate dose in patients with the disease in question. The results must be statistically significant superior to placebo or another scientifically/justified regulatory comparison.