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 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.
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”).
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.
Broadly Applicable MOA: Clinical Proof of Concept Demonstrated Across Multiple Tumors and IO Combination • NBTXR3 + RT in soft tissue sarcoma • CE mark approval in EU based on Phase 3 study showing 16.1% CRR w/ NBTXR3 +RT vs.
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.
Such update to the Development Plan and Budget shall form the basis of any continued Development after the Establishment of Clinical Proof of Concept by both Parties or during a Divestment Process by the Non-Divesting Party, if applicable.
More Definitions of Clinical Proof of Concept
Clinical Proof of Concept means [***] .
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 a measurable biological effect related to the target of interest in an early-phase clinical trial that would be reasonably likely to predict a clinically meaningful effect in an advanced-phase clinical trial.b)80% of the Performance-Based Restricted Share Units awarded hereunder will be earned upon receipt of the first regulatory approval of a Wave drug product by the U.S. Food and Drug Administration or European Medicines Agency (the “Regulatory Approval Milestone”); and c)20% of the Performance-Based Restricted Share Units awarded hereunder will be earned upon the first commercial sale of a Wave drug product (the “Commercial Sale Milestone”).The vesting date for any earned award shall be the date of the certification of the event in writing by the Compensation Committee; provided, however, if any of the events listed above is earned prior to April 1, 2022, then the vesting date of such event shall be April 1, 2022. Such certification shall be final, conclusive and binding on the Participant, and on all other persons, to the maximum extent permitted by law.Notwithstanding the foregoing, in the event the Company consummates a Change of Control and on or within one year following the Change of Control the Participant is terminated by the Company other than for Cause (including in the event of death or Disability) or the Participant resigns from the Company for Good Reason (the “Termination Date”), the Performance-Based Restricted Share Units shall on the Termination Date become immediately vested in full. However, in the event of a Change of Control where the Performance-Based Restricted Share Units are not assumed or substituted in accordance with Section 12.3 of the Plan, the Performance-Based Restricted Share Units shall become immediately vested in full in connection with the Change of Control. No vesting shall occur if the Change of Control or Termination Date is after the Expiration Date.
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.