Phase III Initiation definition

Phase III Initiation means the date of first administration of Product to a patient in a third phase of human clinical trials required by the FDA to gain evidence of efficacy of Product in a target population, and to obtain expanded evidence of safety for Product that is needed to evaluate the overall benefit-risk relationship of Product and provide an adequate basis for physician labeling, as described in 21 CFR Part 312(c), as it may be amended (or its successor regulation).
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Phase III Initiation means the day when the first patient in the first Phase III clinical trial of the relevant Collaboration Product, which trial has been approved by the Joint Steering Committee, gets dosed.
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Phase III Initiation means the date when a Licensed Product is first administered to a patient in the first Phase III Clinical Trial in the Territory.
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Examples of Phase III Initiation in a sentence

  • Together the above Partial Prepayment of Future Royalties of $[***] and Phase III Initiation payment of $400,000 shall be defined as the “Advanced Minimum Royalties”, which shall apply as partial prepayment of future royalties and be credited against the Cumulative Royalties payable by Liquidia to Chasm hereunder.

  • In the event that PPI is entitled to terminate this Agreement pursuant to Section 10.1 after the Phase III Initiation Date, then from and after the time such right of termination first arises, (i) the Applicable Base Royalty Rate applicable to Net Sales of any BI Product in any country shall be *** times such Applicable Base Royalty Rate as would have otherwise applied and (ii) PPI shall retain any and all remedies which may be available to it at law or in equity.

  • 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.

  • The Seller has received from Licensee the full amount of the payments due and payable under Sections 13.1 and 13.2 of the License Agreement, the Phase III Initiation Milestone Event for a [ * ] under Section 13.3.1 of the License Agreement and Section 2(d) of Amendment No. 6.

  • 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.

  • Together the above Partial Prepayment of Future Royalties of $[***] and Phase III Initiation payment of $[***] shall be defined as the “Advanced Minimum Royalties”, which shall apply as partial prepayment of future royalties and be credited against the Cumulative Royalties payable by Liquidia to Chasm hereunder.

  • The Parties hereby agree that, with respect to Table 13.3.1 of the Agreement and CK-452 as a [*] Compound [*], the Milestone Event for Phase III Initiation for CK-452 as a [*] Compound shall be deemed to have occurred on the Amendment Effective Date.


More Definitions of Phase III Initiation

Phase III Initiation means the first dosing of a human subject, in Phase III (Phase Three) Clinical Trials, with a Licensed Product.
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Phase III Initiation means the date the first patient is dosed with an Rx Product by or on behalf of Incyte or SB or their licensees, as the case may be, in the first phase III clinical trial required for the filing of a new drug application with the RA for such Rx Product.
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Phase III Initiation. A payment equal to (1) ******
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Related to Phase III 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 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 III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.