Phase IV Clinical Trials definition

Phase IV Clinical Trials means product support clinical trials of a Collaboration Product commenced after receipt of Regulatory Approval in the indication for which such trial is being conducted.

Phase IV Clinical Trials means certain post-marketing studies to delineate additional information about a pharmaceutical product’s risks, benefits, and optimal use, commenced after receipt of regulatory approval for a product in the indication for which such trial is being conducted.

Phase IV Clinical Trials means post-marketing studies to delineate additional information about a pharmaceutical product’s risks and benefits, and optimal use, commenced after receipt of Regulatory Approval for a Product in the indication for which such trial was conducted.

Examples of Phase IV Clinical Trials in a sentence

• Neither Party shall undertake, or permit its Affiliates or Sublicensees to undertake, any pre-clinical study or Clinical Trial of any Collaboration Product, including Phase IV Clinical Trials, but excluding any studies required for Regulatory Approval or otherwise imposed by a Regulatory Authority and authorized under the Development Plan, without approval of such studies by the JSC.

• To the extent that Braeburn performs post registration, Phase IV Clinical Trials or other Clinical Trials of the Product following receipt of Regulatory Approval for the Product (“Braeburn Post-Registration Studies”), Braeburn shall provide Camurus with draft forms of summary protocols for major studies before commencement of any such study.

• After the Effective Date, all Phase IV Clinical Trials or other pre-clinical or clinical trials that are required by the FDA as a condition to or in connection with an FDA Approval in the United States shall be conducted, administered and funded solely by Esprit or its designees.

• Within five Business Days of the Effective Date, Braeburn shall notify the clinical investigative sites and investigators participating in the Phase IV Clinical Trials (collectively, the “Investigators”) regarding the termination of Braeburn’s responsibility for the applicable Phase IV Clinical Trial and the assumption of sponsorship and control of such Phase IV Clinical Trial by Titan.

• Following the Effective Date, Titan shall be responsible for executing any required amendments or agreements with the Investigators in connection with the foregoing, and Braeburn and Titan shall cooperate in good faith during the Transition Period to ensure that all Phase IV Clinical Trials are transferred in compliance with all Laws and regulations.

More Definitions of Phase IV Clinical Trials

Phase IV Clinical Trials means product support clinical trials of a Product commenced after receipt of Regulatory Approval in the United States for such Product. These trials shall be considered a part of Clinical Work.

Phase IV Clinical Trials means a human clinical trial for a Product commenced after receipt of FDA Approval in the United States and that is conducted within the parameters of the FDA Approval for such Product. Phase IV Clinical Trials may include epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of such Product and post-marketing surveillance studies.

Phase IV Clinical Trials means a human clinical trial, or other test or study, of a compound or product for an indication that is commenced after receipt of the initial Regulatory Approval for such indication in the country for which such trial is being conducted and that is conducted within the parameters of the Regulatory Approval for the compound or product for such indication (and which may include investigator sponsored clinical trials), including a clinical trial conducted due to the request or requirement of a Regulatory Authority or as a condition of a previously granted Regulatory Approval, that would satisfy the requirements of 21 C.F.R. 312.85.

Phase IV Clinical Trials means trials conducted after the Product is marketed for treatment of RA to provide additional details about the Product's efficacy or safety profile. Such trials may be mandatory at the direction of regulatory authorities, or they may be voluntary to collect additional patient information.

Phase IV Clinical Trials means a human clinical trial for a Product in the Field commenced after receipt of FDA Approval in the United States and that is conducted within the parameters of the FDA Approval for such Product. Phase IV Clinical Trials may include epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of such Product and post-marketing surveillance studies.

Phase IV Clinical Trials means product support clinical trials, including -------------------------- new drug delivery systems, of a Collaboration Product with an approved Label claim commenced after receipt of Regulatory Approval in the country where such trial is being conducted. These trials shall be considered a part of Commercialization.

Phase IV Clinical Trials means a human clinical trial for a Product commenced after receipt of FDA Approval in the United States and that is conducted within the parameters of the FDA Approval for such Product. Phase IV Clinical Trials may include epidemiological studies, modeling and pharmacoeconomic studies, investigator sponsored clinical trials of such Product and post-marketing surveillance studies. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.