Phase IV Study definition

Phase IV Study means a human clinical trial of a product which is (a) conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval or (b) conducted voluntarily after Regulatory Approval of the product has been obtained from an appropriate Regulatory Authority for enhancing marketing or scientific knowledge of an approved Indication.

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Phase IV Study means a post-marketing human clinical study for a Licensed Product with respect to any indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program.

Phase IV Study means a clinical study or data collection effort for a Licensed Product that is initiated in one or more countries after the receipt of Regulatory Approval in such country(ies) and is principally intended to support the Commercialization of such Licensed Product in such country/countries and not to support or maintain the same or any additional Regulatory Approvals or otherwise obtain any labeling change. Phase IV Studies shall include, without limitation, clinical experience trials, but shall exclude post-approval studies that are required by a Regulatory Authority as a condition to receiving Regulatory Approval.

Examples of Phase IV Study in a sentence

Subject to Section 5.3 and Section 6.2, the Parties agree that Strata shall own the results and underlying data from any Phase IV Study.
The JDMC shall not have any responsibilities in connection with: (i) any Phase IV Study; (ii) any commercialization or marketing activities in connection with the Product; or (iii) subject to Section 2.4(a)(vi), any manufacturing of commercial supplies of the Compound or the Product.
If the other Party believes in good faith that such proposed Phase IV Study could reasonably be expected to have a Material Adverse Effect on the non-proposing Party, the dispute shall be resolved by the JDC (subject to the dispute resolution procedures set forth in Section 13.6.2).
If it is determined by the JDC or pursuant to such dispute resolution procedures that such proposed Phase IV Study could reasonably be expected to have a Material Adverse Effect on such first Party, the other Party (or its licensees or Sublicensees) shall not be permitted to Conduct the Phase IV Study.
MIOL shall have the right, but not the obligation, to conduct any Phase IV Study which is required, requested or mandated by a Regulatory Authority for the purposes of registering or maintaining the registration of the Product in the Territory; provided, however, that if MIOL does not conduct any Phase IV Study which is required, requested or mandated by a Regulatory Authority in a given country in the Territory, CVT shall have the rights set forth below in this Section 7.2(b).

More Definitions of Phase IV Study

Phase IV Study means a post-marketing human clinical study: (a) for a Licensed Product with respect to any Indication as to which Regulatory Approval has been received or that is the subject of an investigator-initiated study program.

Phase IV Study means: (a) a post-approval clinical study for an Optioned Product with respect to any Indication for which Regulatory Approval has been received or that is required or agreed to be conducted as a condition of receiving Regulatory Approval in a country; as well as (b) any marketing study, epidemiological study, modeling and pharmacoeconomic study, investigator-initiated clinical trial or post-marketing surveillance study of an Optioned Product, in each case (for this clause (b)) that is not intended for use as a basis for obtaining Regulatory Approval (including expanded labeling) with respect to such Optioned Product.

Phase IV Study means a pre-clinical study or human clinical study which is conducted on a product after Regulatory Approval of the product has been obtained from an appropriate Regulatory Authority, and includes (a) studies conducted voluntarily for enhancing marketing or scientific knowledge of an approved Indication (“Non-Required Phase IV Studies”), and (b) studies conducted after Regulatory Approval (i) due to request or requirement of a Regulatory Authority, or (ii) as a condition of a previously granted Regulatory Approval (collectively, “Required Phase IV Studies”).

Phase IV Study means, as applicable, a study or program, designed to: (a) obtain additional safety or efficacy data in support of the Product; or (b) determine effectiveness for additional labelled indications, in either case commenced after Governmental Approval of the Product in the subject country in the Territory.

Phase IV Study means a study initiated in a country after receipt of Regulatory Approval in such country within the approved product labeling.

Phase IV Study means any clinical study in human patients that is commenced after receipt of Regulatory Approval of a Cell Therapy Product in any country of the Territory, which study is conducted within the parameters of the Regulatory Approval, and shall include studies required or requested by the Regulatory Authority as a condition of, or in connection with, obtaining Regulatory Approval with respect to such Cell Therapy Product for a particular Cardiovascular Indication. Phase IV Studies also shall include studies conducted to gather additional information regarding such Cell Therapy Product, including, without limitation, potential risks, medical or pharmacoeconomic benefits, optimal use, dose, route and schedule of administration, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials.

Phase IV Study means a study required by a Regulatory Authority that is a Phase IV post-marketing and safety study, clinical experience study, and all other similar types of studies or investigations for a ThermoDox Product that is initiated in the Territory after receipt of a Marketing Authorization for such ThermoDox Product in the Territory and is principally intended to support the marketing and Commercialization of such ThermoDox Product, including, without limitation, clinical experience investigations and studies conducted to fulfill local commitments made as a condition of any Marketing Authorization. For clarity, no Phase III Studies are included in this definition of Phase IV Studies. Phase IV Study also means the equivalent study in Japan.