Phase II Initiation definition

Phase II Initiation means the date of first administration of Product to a patient in a second phase of human clinical trials required by the FDA to gain evidence of efficacy of Product in a target population, determine optimal dosage, and to obtain expanded evidence of safety for Product, as described in 21 CFR Part 312(c), as it may be amended (or its successor regulation).
View Source
Phase II Initiation means the date when a Licensed Product is first administered to patient for a Phase II Clinical Trial in the Territory.
View Source
Phase II Initiation means the day when the first patient in the first Phase II clinical trial of the relevant Collaboration Product, which trial has been approved by the Joint Steering Committee, gets dosed. If the trial is a Phase I/II trial, the Initiation of Phase II refers to the day when the first patient in the treatment arm designed to determine a reasonable estimate of response rate gets dosed.
View Source

Examples of Phase II Initiation in a sentence

  • Client will accompany such notice with a one-time, non-refundable initiation fee in the amount of [***] (the "Phase II Initiation Fee").

  • The Phase II Initiation, Phase III Initiation and NDA Filing milestones in US, EU and Japan are only payable for first Product under this Agreement, regardless of how many times the milestone may be achieved with another Product.

  • Evotec shall however have the right to pay EUR **** in cash, including **** interest as of the Phase II Initiation, in case Evotec cannot issue the shares for any valid reason.

  • In addition to the consideration specified above, in partial consideration of the rights and licenses granted to CURAGEN under this Agreement, CURAGEN shall pay to TOPOTARGET a non-refundable, non-creditable payment of US$5,000,000 on Phase II Initiation in the United States for the First Product, provided that such event occurs by [*************].

  • As Phase II Initiation milestone for Alzheimer’s Disease, Roche shall be granted a certain amount of shares of Evotec at Phase II Initiation equaling an amount of EUR **** (the “Shares”) at the following terms: The Shares to be granted to Roche shall be calculated by dividing EUR **** through **** of the average of the closing share price of Evotec shares at the German stock exchange on each of the twenty (20) trading days prior to above mentioned Phase II Initiation.

  • As Phase II Initiation milestone for ****, Roche shall be granted a certain amount of shares of Evotec at Phase II Initiation equaling an amount of EUR **** (the “Shares”) at the following terms: The Shares to be granted to Roche shall be calculated by dividing **** through **** of the average of the closing share price of Evotec shares at the German stock exchange on each of the twenty (20) trading days prior to above mentioned Phase II Initiation.

  • If the Phase III Initiation Milestone (AD) is achieved prior to achievement (or deemed achievement) of either of the Phase II Initiation Milestone (AD) or Phase I Initiation Milestone (AD) then each such unachieved AD Development Milestone shall be deemed achieved.

  • If the first Compound developed for Alzheimer’s Disease is ceased, and the second Compound is then developed for Alzheimer’s Disease, the Phase II Initiation and the Phase III Initiation milestone payments shall not be payable, should the milestone (s) in question have already been paid for the first Compound.

  • If the first Compound developed for **** is ceased, and the second Compound is then developed for ****, the Phase II Initiation and the Phase III Initiation milestone payments shall not be payable, should the milestone (s) in question have already been paid for the first Compound.

  • If the Phase III Initiation Milestone (Second Indication) is achieved prior to the achievement (or deemed achievement) of the Phase II Initiation Milestone (Second Indication), then the Phase II Initiation Milestone (Second Indication) shall be deemed achieved.


More Definitions of Phase II Initiation

Phase II Initiation means the first dosing of a human subject, in Phase II (Phase Two) Clinical Trials, with a Licensed Product.
View Source

Related to Phase II Initiation

  • Phase III means a human clinical trial of a Licensed Product, which trial is designed to: (a) establish that a Licensed Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; (c) support regulatory approval of such Licensed Product; and (d) be generally consistent with 21 CFR § 312.21(c). Said trial may be conducted in any country.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase II Trial means a clinical trial of a Licensed Product, designated as a Phase II Trial and the principal purpose of which is to make a preliminary determination that such Licensed Product is safe and active in a patient population for its intended use and is designed to obtain sufficient information about such Licensed Product’s efficacy to permit the design of a Phase III Trial(s), and generally consistent with 21 CFR § 312.21(b). For purposes of this definition, Phase II trial shall specifically exclude expansion cohorts from Phase I Trial(s).

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.