Phase 4 Clinical Trial definition

Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

Phase 4 Clinical Trial means a product support clinical trial of a Product that is commenced after receipt of MAA Approval in the country where such trial is conducted. Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance trials, and any such trials conducted as part of an Expanded Access Program.

Phase 4 Clinical Trial means a Clinical Trial of a Product that (a) is not required for receipt of Regulatory Approval for a country but which may be useful in providing additional drug profile data in support of such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval), or (b) is required, requested or advised by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval). Phase 4 Clinical Trials may include trials or studies conducted in support of pricing/reimbursement approval, epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored Clinical Trials and health economics studies.

Examples of Phase 4 Clinical Trial in a sentence

• For the avoidance of doubt, the cost for Phase 4 Clinical Trial conducted in Territory and/or European Union will be included in Development Costs.

• PTC will also assume responsibility for the planning, conduct and expense of any new investigator-initiated studies or post-approval studies in the PTC Territory (e.g., Phase 4 Clinical Trial) mutually agreed to by the Parties.

• For clarity, Medgenics will take the lead for the Phase 4 Clinical Trial in the European Union and provide KHK or KHK’s designee all the Regulatory Materials with respect to such Phase 4 Clinical Trial for the initial indication.

• Alternatively, Unum may request by written notice to SGI that any Voluntary Phase 4 Clinical Trial that SGI is conducting at its sole expense pursuant to the preceding sentence be included in the Joint Commercialization Plan and the Joint Commercialization Costs attributable to such Voluntary Phase 4 Clinical Trial be allocated on the terms set forth in this Section 8.3(a)(iii), including the applicable premium.

• If Alpharma performs any Phase 4 Clinical Trial or other Clinical Trial of the Product in Subterritory A and the Major Market Jurisdictions following receipt of Regulatory Approval for the Product (each, a “Alpharma Post-Registration Study”), Alpharma shall provide Durect with draft forms of summary protocols for major studies before commencement of any such study.

More Definitions of Phase 4 Clinical Trial

Phase 4 Clinical Trial means a post-registration clinical trial or post-marketing surveillance study performed in accordance with Applicable Laws and required as a condition to, or for the maintenance of, any Marketing Approval or Pricing and/or Reimbursement Approval for a Licensed Product.

Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

Phase 4 Clinical Trial means a product support clinical trial of a Product that is commenced after receipt of MAA Approval in the country where such trial is conducted. Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies and post-marketing surveillance trials.

Phase 4 Clinical Trial means a human clinical trial of a Product commenced after receipt of Regulatory Approval of the Product not for the purpose of satisfying a condition imposed by a Regulatory Authority to obtain Regulatory Approval, but only to support the marketing of such Product.

Phase 4 Clinical Trial means a human clinical trial of the Product in the Territory commenced following receipt of Regulatory Approval in the Territory not for the purpose of satisfying a condition imposed by a Regulatory Authority to obtain Regulatory Approval or receipt of Pricing and Reimbursement Approvals in the Territory, but only to support the marketing of the Product.

Phase 4 Clinical Trial means, with respect to a Licensed Product for a given indication in a given country or jurisdiction, a clinical trial of such Licensed Product for such indication Initiated after receipt of Regulatory Approval for the sale of such product for such indication in such country or jurisdiction. Phase 4 Clinical 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 Clinical Trial means (a) a Clinical Trial of an Optioned Product, conducted following commencement of a pivotal Clinical Trial for such Optioned Product, that is not required for receipt of approval of Marketing Authorization Application, but that may be useful in support of the post-approval Exploitation of such Optioned Product; or (b) a Clinical Trial of an Optioned Product conducted after Marketing Approval of such Optioned Product has been obtained from an appropriate Regulatory Authority due to a request or requirement of such Regulatory Authority.