BID Trial definition

BID Trial means any clinical trial or study undertaken to obtain Regulatory Approval for twice-per-day dosing for the Product to be included on the approved Product label in the Territory, together with any related clinical development activities.
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Examples of BID Trial in a sentence

  • Acerus shall not be entitled to any compensation or reimbursement in connection with any such BID Trial (except for any direct third party pass-through costs invoiced and actually paid by Acerus in connection with its management and coordination pursuant to this Section 3.2, which are preapproved by Aytu in writing).

  • The Parties shall undertake any further development of Product and conduct and cooperate with respect to any clinical trials or studies (including, for greater certainty, any BID Trial or PMR Trial) in a collaborative and efficient manner in accordance with this Article 3.

  • Aytu shall be responsible for all communications and other dealings with the Regulatory Authorities relating to the Post-Approval Regulatory Submissions and Aytu shall be the legal and beneficial owner of all Post-Approval Regulatory Submissions; provided, however, that no Post-Approval Regulatory Submission relating to the BID Trial, Cardiovascular PMR or any PMR Trial may be submitted by Aytu without the consent of Acerus.

  • At its sole and complete discretion, Aytu may elect to, at its cost, conduct and complete a BID Trial (and submit the applicable Regulatory Submission to the applicable Regulatory Authorities) with respect to the Product with a view to obtaining an approved dosing protocol providing for twice-daily (“BID”) usage of the Product.

  • Any such BID Trial (and associated Regulatory Submission) shall be completed at Aytu’s expense, provided that such trial shall be required to be conducted in accordance with the draft protocol developed therefor by Acerus (subject to such changes as Acerus may make in its discretion, acting reasonably), and Acerus shall be engaged and retained to manage and coordinate any such trial, including oversight of any Third Parties required to be engaged by Aytu in connection with the conduct of such trial.

Related to BID Trial

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Pivotal Study means (a) a Phase 3 Study that is intended by Celgene to be submitted (together with any other registration trials that are prospectively planned when such Phase 3 Study is initiated) for Regulatory Approval in the U.S. or the EU, or (b) any other clinical study that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing an application for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra-national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product after completion of such study.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.