Ongoing Study definition

Ongoing Study means [***].
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Ongoing Study means [***] clinical trial of Product in Japan that was started prior to the Effective Date and is scheduled to be completed after the Effective Date.
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Examples of Ongoing Study in a sentence

  • BioMarin shall use Diligent Efforts to transfer all analytical methodology used for the stability testing of BioMarin’s clinical inventory of Firdapse to a Third Party contract manufacturer, selected by Catalyst, in a time frame that will enable such Third Party contract manufacturer to initiate and conduct stability testing of all additional clinical supplies for the BioMarin Ongoing Study.

  • BioMarin shall deliver (or cause to be delivered) to Catalyst, free of charge, BioMarin’s clinical inventory of Firdapse and placebo reserved for the BioMarin Ongoing Study, as set forth in Exhibit E, to be used by Catalyst as its clinical supply for the BioMarin Ongoing Study.

  • For the avoidance of doubt, Catalyst shall have no obligation to pay or reimburse BioMarin for any Development costs incurred by or on behalf of BioMarin or its Affiliates on or after the Effective Date other than Out-of-Pocket Ongoing Study Costs in accordance with this Section 3.7(a).

  • BioMarin and its Affiliates shall transfer the Licensed Technology to Catalyst for a period of six (6) months, or such longer period as the Parties may mutually agree upon in order for all Licensed Technology that is required or reasonably useful for Catalyst’s conduct of the Ongoing Study and other Development activities hereunder to be transferred in full to Catalyst (the “Transfer Period”).

  • Promptly following the Effective Date, the Parties will discuss, plan, and collaborate on the transfer of responsibilities to Catalyst for the BioMarin Ongoing Study listed on Exhibit A.

  • Catalyst shall reimburse BioMarin for Out-of-Pocket Ongoing Study Costs in accordance with this Section 3.7(a) within forty-five (45) days of Catalyst’s receipt of a statement from BioMarin summarizing in reasonable detail all such Out-of-Pocket Ongoing Study Costs incurred, together with such invoices or other appropriate supporting documentation as Catalyst may reasonably request.

  • If either the OPTIC Clinical Trial or the OPTIC 2L Clinical Trial is terminated prior to [**], then the maximum aggregate amount owed by ARIAD SWISSCO with effect from the date of termination of the relevant Ongoing Study, shall be [**] of the remaining Ongoing Studies Budget.

  • Ongoing Study ManagementStudy staff at each participating site must conduct the trial according to the protocol, their local institutional policies, and the policies of the applicable regulatory bodies.

  • Tanz, Karen Wills, Barbara White, Martha Barthel, Patricia McGuire, Mark Donovan, Flavia Buergo, Nancia Shawver, and Jeffrey Jenq, " Kids 'N' Cars, An Ongoing Study of Pedestrian Injuries: Description and Early Findings," Children's Environment Quarterly, Volume 8, Number 2, 1991.

  • Economic Incentives for Watershed Protection: A Report on an Ongoing Study of Arenal, Costa Rica.

Related to Ongoing Study

  • Phase 3 Study means a clinical study of a drug candidate in patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety in order to obtain Regulatory Approval in any country, as further described in 21 C.F.R. 312.21(c) with respect to the United States, or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase III Clinical Trial means a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Clinical Study means a Phase I Study, Phase II Study (including a Phase II(a) and Phase II(b) Study), Phase III Study or Post-Approval Studies, as applicable.

  • Development Plan has the meaning set forth in Section 3.2.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.