Successful U.S. Phase III definition

Successful U.S. Phase III means the earlier of (i) achievement of clinically relevant and statistically significant efficacy in the primary endpoint(s) of the Phase III studies for CC pursuant to a protocol agreed with the United States Food and Drug Administration with consistent overall efficacy in the secondary endpoints and safety [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. data sufficient (i.e. unexpected findings compared to previous trials that could prevent Regulatory Approval or adversely impact product labeling) for use as pivotal trials for filing an NDA with a reasonable likelihood of receiving marketing approval from the United States Food and Drug Administration or (ii) a public announcement by Forest of a successful Phase III or of an intent to submit an application for Regulatory Approval based on the results of a Phase III study.
Sample 1
Successful U.S. Phase III means the earlier of (i) achievement of clinically relevant and statistically significant efficacy in the primary endpoint(s) of the Phase III studies for CC pursuant to a protocol agreed with the United States Food and Drug Administration with consistent overall efficacy in the secondary endpoints and safety data sufficient (i.e. unexpected findings compared to previous trials that could prevent Regulatory Approval or adversely impact product labeling) for use as pivotal trials for filing an NDA with a reasonable likelihood of receiving marketing approval from the United States Food and Drug Administration or (ii) a public announcement by Forest of a successful Phase III or of an intent to submit an application for Regulatory Approval based on the results of a Phase III study.
Sample 1

Examples of Successful U.S. Phase III in a sentence

  • In the event that Successful U.S. Phase III occurs prior to an initial public offering by Ironwood, the Investment will be made pursuant to a Stock Purchase Agreement (as defined below) pursuant to which Partner will purchase 681,819 shares of a new series of preferred stock at a per share purchase price equal to $22.00 per share.

  • In the event that Successful U.S. Phase III occurs following an initial public offering by Ironwood, the Investment will be a purchase of 681,819 shares (as appropriately adjusted for any stock dividends, combinations, splits, recapitalizations and the like occurring after the Effective Date) of Series B Common Stock (as such term is defined in the Tenth Amended and Restated Certificate of Incorporation of Ironwood Pharmaceuticals, Inc.

  • Subject to Ironwood obtaining the necessary consents and approvals by its board and shareholders, within 10 days of Successful U.S. Phase III, [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.

  • Subject to Ironwood obtaining the necessary consents and approvals by its board and shareholders, within 10 days of Successful U.S. Phase III, Partner will purchase from Ironwood capital stock of Ironwood (the “Investment”) for an aggregate purchase price of $15,000,000 as described in this Section.

Related to Successful U.S. Phase III

  • Successful Completion means that in the reasonable opinion of the Customer, Deliverables completed by the Supplier are fit for purpose, completed on time and otherwise meet all the criteria defined under this Contract;

  • Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • 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.

  • Successful Syndication shall have the meaning given to such term in the Fee Letter.

  • 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.

  • Successful Bid means the Bid of the Successful Bidder for acquisition of assets of the Corporate Debtor and as declared by the Liquidator in terms of sub-clause VIII of Clause 5.4 of this document.

  • 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).

  • Development Phase means the period before a vehicle type is type approved.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Start-Up Costs means all fees, costs, and expenses incurred in connection with establishing the State Mitigation Trust and the Indian Tribe Mitigation Trust and setting them up for operation. Start-up costs shall not include the cost of premiums for insurance policies.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Successful Bidder As defined in Section 7.01(c).

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.