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 set forth on Schedule 1.54.
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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

  • Merck Serono shall be responsible for executing any required amendments or agreements with the Investigators in connection with the foregoing, and will be solely responsible for ensuring that all Existing Clinical Trials are transferred in compliance with all Laws and regulations.

  • Seller has not received any written notice, charge, subpoena or other request for information, which has not been complied with or withdrawn, from a Governmental Authority asserting any material breach of the conditions for approval of any Existing Clinical Trials for the Product.

  • 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.

  • 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.

  • 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.

  • Seller and its Affiliates have made all necessary material filings and received all necessary material approvals and consents for the conduct of the Existing Clinical Trials from the necessary Governmental Authorities and, to Seller’s Knowledge, there is no Litigation pending or threatened by such Governmental Authorities to suspend or terminate any ongoing Existing Clinical Trials.

  • Centocor will promptly provide to MV on a confidential basis copies of all agreements (including without limitation clinical protocols) relating to the four (4) clinical trials/beta testing currently being performed with the MicroVision Systems (the "Existing Clinical Trials").

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

  • It is much easier to foster proper habits from the beginning of training than to correct faulty ones later.

  • 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.


More Definitions of Existing Clinical Trials

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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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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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, 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 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 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.

  • 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.

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

  • 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 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.

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

  • 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 an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

  • 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).