Phase 4 Trial means clinical trial of a Product Commenced in a particular country after Regulatory Approval for such Product in such country in order to support commercialization of the Product.
Phase 4 Trial means, with respect to a Product, (a) any Clinical Study conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval for such Product or (b) any Clinical Study conducted after the first Regulatory Approval in the same disease state for which such Product received Regulatory Approval other than for purposes of obtaining Regulatory Approval.
Phase 4 Trial means a clinical trial of a Product, possibly including pharmacokinetic studies, which trial (a) is not required to be completed prior to obtaining Regulatory Approval of an Indication; and (b) either (i) is required by the applicable Regulatory Authority as mandatory to be conducted on or after the Regulatory Approval of an Indication, or (ii) is conducted voluntarily to enhance marketing or scientific knowledge of the Product (e.g., providing additional drug profile, safety data or marketing support Information, or supporting expansion of Product labeling).
Examples of Phase 4 Trial in a sentence
The review can be between six to ten months or longer with success rates at this phase of approximately 85%. Phase 4 Trial – Post Approval SurveillanceThese are any trials conducted after FDA approval of the drug.
During the Phase 4 trial Granite 18 offered and the Court admitted the declarations of William Taylor (Granite-1) and Steven19McCracken (Granite-2) during the Phase 4 Trial establishing Granite’s property ownership and20the amount of water produced from the Property and the use to which that groundwater was put2122 during years 2011 and 2012.
The Phase [4] Trial shall not result in any determination of any water right, or the reasonableness of any party’s water use or manner of applying water to the use.
If the businesses of the Gallant Group and the IMAS Group are not integrated successfully, the Business and any investment in the Shares may be materially and adversely affected.
More Definitions of Phase 4 Trial
Phase 4 Trial means a clinical trial for the Licensed Product that is initiated in a Country after receipt of Regulatory Approval for the Licensed Product in such Country and is principally intended to support the marketing and Commercialization of the Licensed Product, including investigator initiated trials and clinical experience trials. “prGCD” means a plant cell expressed recombinant human Glucocerebrosidase enzyme having the sequence set forth in Exhibit A to this Agreement.
Phase 4 Trial means any clinical trial in an Indication to be conducted after a Regulatory Approval which was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval.
1. 105 “Physician Group” means a category of physicians and other medical professionals to whom one or more Products is being Promoted, or will be Promoted if then-current Development activities are successful. For purposes of this definition, all oncologists (without regard to whether they treat a particular type or stage of cancer) shall be a single Physician Group.
1. 106 “Post-Approval Clinical Trial” shall have the meaning set forth in Exhibit C.
1. 107 “Product” means [****].
Phase 4 Trial means (a) any Clinical Study conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval or (b) any Clinical Study conducted after the first Regulatory Approval in the same disease state for which a Product received Regulatory Approval other than for purposes of obtaining Regulatory Approval .
Phase 4 Trial means a Clinical Trial commenced after receipt of Regulatory Approval and which is intended to support the Commercialization of Symproic. Phase 4 Trials may include, without limitation, epidemiological studies, modeling and pharmacoeconomic studies, investigator-sponsored clinical trials of Symproic and post-marketing surveillance studies.
Phase 4 Trial means a clinical trial of a Collaboration Product Commenced in a particular country after receipt of Regulatory Approval in such country in order to support commercialization of the Collaboration Product.
Phase 4 Trial means a clinical trial of a pharmaceutical product, possibly including pharmacokinetic studies, which trial (a) is not required to be completed prior to obtaining Marketing Approval for an indication; and (b) either (i) is required by the applicable Regulatory Authority as mandatory to be conducted on or after the Marketing Approval of an indication, or (ii) is conducted voluntarily to enhance scientific knowledge of such product (e.g., providing additional drug profile, safety data or marketing support information, or supporting expansion of product labeling). Confidential 15
Phase 4 Trial means a human Clinical Study of the Licensed Product conducted after Regulatory Approval of the Licensed Product has been obtained from an appropriate Regulatory Authority, and includes (a) trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and (b) trials conducted after Regulatory Approval due to request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval, including studies conducted in response to a paediatric written request or condition of approval studies. 1.116 “Pivotal Study” means, with respect to the Licensed Product, a Clinical Study that: (a) would satisfy the requirements of a Phase 3 Trial; (b) Pharming designates as a pivotal, or registrational, Clinical Study; or (c) is otherwise designed to generate efficacy data having a nature and quality that will be sufficient to support a Drug Approval Application for the Licensed Product. For clarity, a Pivotal Study described in sub-clause (c) may be any form of Clinical Study; provided, however, that, for any Clinical Study other than a Clinical Study described in sub-clause (a), such Clinical Study shall be deemed a Pivotal Study only: (i) if the applicable Regulatory Authority agrees in writing that such Clinical Study will be deemed a pivotal trial sufficient for obtaining Regulatory Approval of the Licensed Product with no further Clinical Studies being conducted prior to the grant of such Regulatory Approval; or (ii) upon the filing of a Drug Approval Application with 22 the FDA, EMA or any Regulatory Authority in the European Union by Pharming, any of its Affiliates, or any Sublicensee for the Licensed Product based upon the results of such Clinical Study as a pivotal study, in which case, for the avoidance of doubt, such Pivotal Study shall also be deemed to have been Initiated.