Phase 4 Trial definition

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 (i) any clinical trial in humans conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval and (ii) any clinical trial in humans conducted after the first Regulatory Approval in the same disease state for which the Collaboration Compound or Licensed Product received Regulatory Approval in the Territory.

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.

Examples of Phase 4 Trial in a sentence

• 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 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.

• A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA).

• The qualitative effects are understood as the stable supply of water of a certain quality, and achievement of the effects is assessed from the situation at the time of ex-post evaluation.

• 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.

More Definitions of Phase 4 Trial

Phase 4 Trial means any clinical study initiated in the Collaboration Territory for a Product following the first Regulatory Approval for the sale of such Product in the Collaboration Scope for the indication being studied. Phase 4 Trials may include epidemiological studies, modeling and pharmacoeconomic studies, and post-marketing surveillance studies, as well as any clinical study or research study sponsored and conducted by an individual not employed by or on behalf of either Party.

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.

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 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 any study initiated in the Territory for a Product following the first Regulatory Approval for the sale of such Product for the Indication being studied whether or not required by a Governmental Authority. Phase 4 Trials may include epidemiological studies, modeling and pharmacoeconomic studies, and post-marketing surveillance studies, as well as any clinical study or research study sponsored and conducted by a Person not employed by or on behalf of either Party. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL.

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).

Phase 4 Trial means a human clinical trial for a Program Product commenced after receipt of Approval in the country for which such trial is being conducted and that is PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES OMISSIONS. conducted within the parameters of the Approval for the Program Product. Phase 4 Trials may include epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of Program Product and post-marketing surveillance studies.