Phase 3 Clinical Study means a human clinical study of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(c) and that is designed or intended to (a) establish that the product is safe and efficacious for its intended use, (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product.
Phase 3 Clinical Study means expanded controlled and uncontrolled human clinical trials pursuant to a randomized study with endpoints agreed upon by regulatory bodies for regulatory approval performed after Phase 2 Clinical Trial evidence suggesting effectiveness of a drug has been obtained, and is intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a drug and to provide an adequate basis for regulatory approval and physician labeling, as in compliance with 21 C.F.R. §312 or foreign equivalent, and shall include a confirmatory study that is conducted following conditional regulatory approval.
Phase 3 Clinical Study means a Clinical Study of Licensed Product that meets the definition of a Phase 3 study in the Clinical Trial Regulation EU No 536/2014 and for the United States as described in 21 C.F.R. §312.21(c), or its successor regulation, or the equivalent regulation in any other country.
Examples of Phase 3 Clinical Study in a sentence
Commencing with the initiation of the first Phase 3 Clinical Study of the Licensed Product in the Territory, the Parties shall establish a joint commercialization team (“JCT”) to serve as a forum to discuss Commercialization of the Licensed Product in the Field in the Parties’ respective Territory.
Each such Phase 3 Clinical Study Report shall be delivered within thirty (30) days after the date of Completion of the relevant Phase 3 Clinical Trial Development.
Ardelyx shall have the right to exercise the Co-Promote Option in respect of such Licensed Product for the first indication for which Phase 3 Clinical Trial Development has been Completed as described in subsection (a) above, by providing to AstraZeneca, within thirty (30) days after its receipt of the Phase 3 Clinical Study Report, a written notice of its election to do so.
Each such Phase 3 Clinical Study Report shall be delivered within thirty (30) days after the date of Completion of such Phase 3 Clinical Trial.
Successful Completion of the first Phase 3 Clinical Study $ 250,000 (ii) Receipt of Marketing Approval of Licensed Product in the United States $ 750,000 Each of the above milestone payments will be payable only upon the first occurrence of the applicable event, regardless of how many times the event is ultimately achieved.
More Definitions of Phase 3 Clinical Study
Phase 3 Clinical Study has the same meaning as set forth in 21 C.F.R. Section 312.21(c), including any and all amendments, modifications or changes thereto as may be made thereto in the future, or the equivalent thereof, in any applicable country within the Territory.
Phase 3 Clinical Study shall also include any other human clinical trial serving as a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a “Phase 3” study. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase 3 Clinical Study” hereunder if such study has been designated by the sponsor as a Phase 3 [III] clinical trial on xxx.xxxxxxxxxxxxxx.xxx (or any successor website maintained by the U.S. National Institutes of Health (or any successor agency of the U.S. Government)).
Phase 3 Clinical Study means a study of a Licensed Product in human patients with a defined dose or a set of defined doses of a Licensed Product designed to (a) ascertain efficacy and safety of such Licensed Product 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; and (c) support preparing and submitting applications for Regulatory Marketing Approval to the competent Regulatory Authorities in a country of the world, as and to the extent defined for the United States in 21 C.F.R.§ 312.21(c), or its successor regulation, or the equivalent regulation in any other country. “Phase 3 Clinical Study” shall also include any other human clinical trial serving as a pivotal study from which the data are actually submitted to the applicable Regulatory Authority in connection with a Regulatory Marketing Approval Application, whether or not such trial is called a “Phase 3” study. Without limiting the generality of the foregoing, a clinical study shall be deemed to be a “Phase 3 Clinical Study” hereunder if such study has been designated by the sponsor as a Phase 3 [III] clinical trial on xxx.xxxxxxxxxxxxxx.xxx (or any successor website maintained by the U.S. National Institutes of Health (or any successor agency of the U.S. Government)).
Phase 3 Clinical Study means that portion of the drug development and review process in which expanded clinical studies are conducted to gather the additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of an investigational new drug that would satisfy the requirements specifically defined by the rules and regulations of the FDA under 21 § C.F.R. 312.21(c), or similar rules and regulations in other countries or jurisdictions. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Phase 3 Clinical Study. Phase 3 Clinical Study shall mean a clinical study in patients, conducted in accordance with a protocol designed to ascertain efficacy and safety of a Compound for the purpose of preparing and submitting an NDA to the competent Regulatory Authorities in the Territory.
Phase 3 Clinical Study means a human clinical trial in the Territory, which are performed after Phase 1/2b Clinical Study, the results of which could be used to establish safety and efficacy, and to determine warnings, precautions, and adverse reactions of the Product as a basis for an NDA.
Phase 3 Clinical Study means a controlled clinical study, or a portion of a controlled study, in humans of the efficacy and safety of a pharmaceutical product, which study (in its entirety or portion, as applicable), is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an application to obtain Regulatory Approval, as further defined by Indian Regulatory Authorities.