Bridging Study definition

Bridging Study means an additional Clinical Trial consisting of up to fifty (50) patients from the Territory that allows extrapolation of a foreign pivotal data package to support Regulatory Approval of such Licensed Product in the Territory.
View Source
Bridging Study means a supplemental Clinical Trial of a Licensed Product conducted in Japan that is designed to (a) allow extrapolation of pivotal data obtained from a Registrational Clinical Trial within the Arcus Know-How that, in TAIHO’s good faith opinion, did not include sufficient number of Japanese (or other acceptable Asian) patients to obtain Marketing Approval for such Licensed Product by Japanese Regulatory Authorities based solely on the Arcus Know-How and (b) generate all additional clinical data that, along with data within the Arcus Know-How, will be sufficient to obtain Marketing Approval for such Licensed Product in Japan.
View Source
Bridging Study means the Clinical Trial conducted [ * ] as described in Schedule 2.1 as such study may be modified from time-to-time as part of the Development Plan in accordance with Section 2.4.3.
View Source

Examples of Bridging Study in a sentence

  • Study # 20001926 Title: A 7-Day Dermal Bridging Study in [*] (Reference scope of work dated: 06-Aug-2010) $ 49,900 In order to minimize the impact of study delays and cancellations for all sponsors, ▇▇▇▇▇▇▇ River allocates resources at the time a signed Letter of Payment Authorization is received.

  • The milestones in the table immediately below in this Section 5.2(b) shall be due upon Achievement of such milestones so long as TAIHO or its Sublicensee is able (in TAIHO’s opinion, acting in good faith) and intends to obtain Marketing Approval based solely on Arcus Know-How generated from Clinical Trials conducted by, or by a Third Party under authority of, Arcus or its Affiliates and a Bridging Study conducted by TAIHO or its Sublicensee in the Territory (“Bridging Study Pathway”).

  • For avoidance of doubt, the milestones in the table immediately below shall not be due if TAIHO determines (in its opinion) not to pursue the Bridging Study Pathway for the applicable Licensed Product and TAIHO or its Sublicensee conducts a human clinical study of such Licensed Product that is not a Bridging Study (in which case Section 5.2(a) above or 5.2(c) below shall apply).

  • In the event Taiho is required to conduct additional clinical studies in Japan beyond the Bridging Study to establish the safety and/or efficacy of a Product to obtain or to maintain Marketing Approval in Japan (even if required to be conducted after obtaining such Marketing Approval), then the payments (if any) otherwise due for R&D Events […***…] and […***…] (after other adjustments) with respect to such Product shall be reduced by […***…] percent ([…***…]%).

  • If the [*] the PK Bridging Study [*] in accordance with [*] set forth above.


More Definitions of Bridging Study

Bridging Study means an additional Clinical Trial consisting of up to fifty (50) patients from the Territory
View Source
Bridging Study means a human clinical trial in any country acceptable to FDA approval using the Vaccine, that is designed so that the results can be used to support initiation of the Definitive Clinical Trial (as defined hereinafter) with the Vaccine as the next step in the clinical program under the Development Plan and to support the acceptance by FDA of prior relevant preclinical and clinical study results in the further course of the Vaccine development.
View Source
Bridging Study means any clinical trial conducted in a country to provide clinical data on safety, efficacy, dosage, and dose regimen to permit the extrapolation of foreign clinical data to the population in such country or in relation to Regulatory Approvals or secondary manufacturing approvals in such country.
View Source
Bridging Study means one or more subjects undertaken on a non-award basis by an overseas trained professional seeking to meet the formal requirements for entry into their profession in Australia. An Assessment Statement from the relevant professional body, recognised by the Department of Industry, Innovation, Science, Research and Tertiary Education (DIISRTE), is required to classify study as bridging study.
View Source
Bridging Study means […***…] It is understood that a Bridging Study shall not include […***…].
View Source
Bridging Study shall have the meaning set forth in Article 3.4.3 (b).
View Source
Bridging Study means a clinical study conducted in the Territory for the purpose of providing pharmacodynamic or clinical data on efficacy, safety, dosage and dose regimen in the Territory to allow extrapolation of the clinical data generated by Ardelyx, its Affiliates or its licensees outside of the Territory. The Bridging Study may be a pharmacokinetics study or a full clinical trial, as required by the Regulatory Health Authorities in the Territory.
View Source