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 the ongoing clinical trial commitments set forth on Schedule 1.1.1.
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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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Examples of Existing Clinical Trials in a sentence

  • Vertex will at all times maintain accurate and complete records regarding FTE Costs, Supply Costs and Out- of-Pocket Costs incurred in connection with the Conduct of the Existing Clinical Trials for as long as required by Applicable Law, but in no case [***] following the period during which such costs were incurred.

  • The Deputy Chief Prosecutor of the Prosecution Office shall replace the Chief Prosecutor in the absence of the latter.

  • 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.

  • Employs generally accepted accounting, engineering, and planning methodologies, including the buy-in, incremental cost or marginal cost, and combined cost methods for each service, setting forth appropriate analysis as to the consideration and selection of a method appropriate to the circumstances and adapted as necessary to satisfy all requirements of this Article.

  • 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.

  • 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.

  • Within [***] after the Effective Date, the Parties will establish a transition committee (the “TC”) to oversee and coordinate activities related to the 24technology transfer set forth in Section 4.2 and the Conduct of the Existing Clinical Trials.


More Definitions of Existing Clinical Trials

Existing Clinical Trials means any on-going Phase 1 clinical trials conducted by Daiichi Sankyo or its Affiliates as of the Effective Date listed on Exhibit C.
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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.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to 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 I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 BMS and that otherwise fit the foregoing definition.

  • 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.

  • Pivotal Clinical Trial means a clinical study of an investigational product in patients with the primary objective of confirming with statistical significance the efficacy and safety with the aim to obtain regulatory approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant regulatory authority in a country other than the United States.

  • Clinical Studies means Xxxxx 0, Xxxxx 0, Xxxxx 0, Xxxxx 3, and such other tests and studies in human subjects that are required by Applicable Law, or otherwise recommended by the Regulatory Authorities, to obtain or maintain Regulatory Approvals for a Licensed Product for one (1) or more indications, including tests or studies that are intended to expand the Product Labeling for such Licensed Product with respect to such indication.

  • 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 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 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. [***]

  • 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 (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • 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.