Existing Clinical Trials definition

Existing Clinical Trials means the ongoing clinical trial commitments set forth on Schedule 1.25, which schedule lists the applicable study title, study number, protocol number (if different from any study number).
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Existing Clinical Trials means those Clinical Trials, ***,” that were initiated by or on behalf of Arius or Parent prior to, and are ongoing as of, the Effective Date.
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Existing Clinical Trials means those Clinical Trials set forth on Schedule 1.54.
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Examples of Existing Clinical Trials in a sentence

  • It should also list the sector(s) that the requested grant funds seeks to support (Libraries, Public Safety, Education, etc…), identify the barriers and objectives addressed by your grant project, and name the specific beneficiary.

  • In case Inventory is not sufficient to complete the Existing Clinical Trials, or to secure supply of Licensed Compounds during the hand-over period of Third Party vendor contracts as defined in Section 4.2.5, the TC shall agree on the strategy according to which Vertex shall use Commercially Reasonable Efforts to supply Licensed Compound in addition to Inventory for use in the Existing Clinical Trials in accordance with the Clinical Trials Transfer Plan.

  • In case Merck’s qualification of the contract manufacturing organizations being used by Vertex to Manufacture Clinical Trial supply of Licensed Compounds and Products as of the Execution Date fails, the Parties will cooperate to resolve any such failure prior to the transfer of the Existing Clinical Trials to Merck; provided that in no event will Vertex be obligated to provide support in resolving such failures after the date that is [***] from the Effective Date unless the Parties agree otherwise.

  • Schedule 1.54 contains an overview of the Existing Clinical Trials, including their current protocols, as well as a preliminary outline of a transfer plan (the “ Existing Clinical Trials Transfer Outline”).

  • BDSI shall notify Endo on a timely basis of any adverse events occurring at or reported by any Clinical Trial location at which BDSI is responsible for performing BDSI Trials or Supportive Trials or may be conducting the Existing Clinical Trials.

  • To avoid incurring additional costs and prolonging the time required for completing the phase III clinical trials for CMAB007 and CMAB008, the Group retained Biomabs to continue the phase III clinical trials for CMAB007 and CMAB008 and entered into the Existing Clinical Trials Agreement with Biomabs.Due to the outbreak of COVID-19, there has been a delay in the clinical trials of CMAB007.

  • Subject to the terms and conditions of this Agreement, BDSI hereby grants to Endo an exclusive (including with respect to BDSI except as to BDSI’s performance of its obligations under this Agreement or conduct of the Existing Clinical Trials) license (with the right to sublicense solely in accordance with Section 8.4) in the Field in the Territory, under the BDSI Intellectual Property, to develop, make or have made, use, offer for sale, sell, import, market and promote Product.

  • The TC shall, within [***] of the Effective Date, expand the Existing Clinical Trials Transfer Outline into a more detailed transfer plan, including a19timeline as well as a cost estimate, which detailed transfer plan shall be consistent with the protocols of the Existing Clinical Trials as they exist on the Execution Date (the “ Clinical Trials Transfer Plan”) and have oversight and monitor the transfer activities contemplated hereunder.

  • Subject to the terms and conditions of this Agreement, BDSI hereby grants to Endo an exclusive (including with respect to BDSI except as to BDSI’s performance of its obligations under this Agreement and conduct of Existing Clinical Trials) license (with the right to sublicense in accordance with Section 8.4) to use the BDSI Trademarks solely in connection with Product in the Territory.

  • The Parties shall use their Commercially Reasonable Efforts to effect the transfer of legal responsibility for the conduct of the Existing Clinical Trials and render Endo the sponsor thereof for all legal purposes in a smooth and orderly fashion consistent with applicable law, Regulatory Requirements, and any existing contracts with Third Parties for the conduct of such Existing Clinical Trials.


More Definitions of Existing Clinical Trials

Existing Clinical Trials means the ongoing clinical trial commitments set forth on Schedule 1.1.1.
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Existing Clinical Trials means the Clinical Trials in respect of Monotherapies and Combination Regimens being conducted by or on behalf of Novartis as of the date of this Agreement, as more particularly set forth on Exhibit A. The high-level key terms of the Transition Plan are set forth on Exhibit B. BeiGene and Novartis will amend or enter into a new pharmacovigilance agreement within […***…] after this Agreement, and Novartis will use good faith efforts to transition the global safety database for the Licensed Product to BeiGene as soon as reasonably possible. The November purchase order under the Master Supply Agreement for supply of Licensed Product and Licensed Compound is hereby cancelled and Novartis agrees to reimburse BeiGene for […***…] due under such purchase order. BeiGene will invoice Novartis for such amount, and Novartis shall pay such invoice within sixty (60) days after receipt.
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Related to Existing Clinical Trials

  • 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.

  • 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 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.

  • 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 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 I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • 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.

  • 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 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).

  • 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.

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

  • 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 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 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 Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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.

  • 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 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.

  • 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.

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • 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).

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;