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.
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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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Transferred Clinical Trials means the clinical trials designated with the following CxxxxxxxXxxxxx.xxx identifiers: [***] and [***].
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Examples of Transferred Clinical Trials in a sentence

  • Daiichi Sankyo and/or its Affiliates will timely prepare and submit 2021 development safety update reports (“DSUR”) for the Transferred Clinical Trials and Continuing Clinical Trials.

  • 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).

  • 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.

  • 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.

  • 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 [***].

  • 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.

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

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

  • Without limiting its obligations under Section 3.2.1, Licensee shall be solely responsible, at its own cost and expense, for conducting and completing all Transferred Clinical Trials and any other trial to satisfy post-marketing commitments necessary or desirable to obtain or maintain Regulatory Approval of and enable and support the Manufacture and Commercialization of Licensed Products in the Territory.


More Definitions of Transferred Clinical Trials

Transferred Clinical Trials has the meaning set forth in Section 7.2(b).
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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, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory 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 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 IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • 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.

  • 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 a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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).

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Clinical Trial means any human clinical trial of a Product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

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

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

  • 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.

  • Non-Participating Clinical Laboratory means a Clinical Laboratory which does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan provide services to you at the time services are rendered.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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;

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;