Transferred Clinical Trials definition

Transferred Clinical Trials means on-going Phase 1 clinical trials listed on Exhibit C which are conducted by Daiichi Sankyo or its Affiliates as of the Effective Date and will be transferred to Rain after the Effective Date in accordance with Section 3.1.5. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. EXECUTION VERSION
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Transferred Clinical Trials has the meaning set forth in Section 7.2(b).
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Transferred Clinical Trials means those clinical trials of the Licensed Product which are listed in Schedule 1.83.
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Examples of Transferred Clinical Trials in a sentence

  • Rain shall be responsible for the cost of Transferred Clinical Trials incurred after the Effective Date at its own expense.

  • Rain shall be responsible for preparing and submitting 2022 DSUR and thereafter for the Transferred Clinical Trials and Continuing Clinical Trials.

  • Subject to Section 3.1.4, Rain and Daiichi Sankyo shall discuss when and how Rain takes over Daiichi Sankyo’s responsibility for Transferred Clinical Trials within [***] after the Effective Date.

  • Except for materials transferred under Section 3.3.2, Rain will be solely responsible at its expense for manufacturing of all of the Licensed Compound and Product that are necessary for further development and commercialization of such Licensed Compound and Product after the Effective Date (except for the Transferred Clinical Trials until transferred and Continuing Clinical Trials until completion).

  • Note: - Bidders should be in touch with websites https://UGVCL.nprocure.com &w ww.UGVCL.com for information regarding revision/corrigendum/amendment intender till due date of online submission and thereafter.

  • Daiichi Sankyo shall provide Rain with the draft of itemized [***] invoice for customary and reasonable Third Party costs and expenses incurred for CRO services, data management and biostatistics after the Effective Date to continue the Transferred Clinical Trials until the transfers are completed, to the extent consistent with a budget agreed by the Parties as of the effective date of above agreement related to [***].

  • Rain shall be responsible for preparing the final report for the Transferred Clinical Trials other than [***] study on its own or by another vendor of its choice, and Daiichi Sankyo shall have no responsibility for preparing such final report.

  • With respect to the on-going Phase 1 clinical trial of DS-3032b in combination with [***] (i.e., Daiichi Sankyo’s internal reference code for clinical trial “[***]”) which is one of the Transferred Clinical Trials, Daiichi Sankyo and Rain shall execute an agreement for the terms and conditions that includes the following but not limited to: (i) supply of [***], (ii) regular update of study status, (iii) safety data exchange and (iv) ownership of the results and IP.

  • Upon a written request from Rain, Daiichi Sankyo will transfer interim trial data and audit/compliance-related documents from the Transferred Clinical Trials and Continuing Clinical Trials to Rain.

  • Licensee will use all reasonable efforts to maintain in full effect such CTAs (for so long as needed to complete the Transferred Clinical Trials) and Regulatory Approvals, and Licensee will use all reasonable efforts to timely perform all responsibilities of the regulatory sponsor or the MAH, as applicable, with respect thereto.


More Definitions of Transferred Clinical Trials

Transferred Clinical Trials means the clinical trials designated with the following CxxxxxxxXxxxxx.xxx identifiers: [***] and [***].
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Related to Transferred Clinical Trials

  • 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.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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 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 III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;