Cardiovascular Indications definition

Cardiovascular Indications means myocardial infarction (whether chronic (e.g., ischemia) or acute) and peripheral vascular disease (excluding neurovascular) in humans.
Sample 1Sample 2Sample 3
Cardiovascular Indications means the treatment and prevention of any disorders of the heart, blood vessels, or kidney and disorders due to ischemia or hypoxia of any organ or tissue except the brain.
Sample 1Sample 2Sample 3
Cardiovascular Indications shall include three groups of disease and/or conditions as follows: Group A — ***** (hereinafter “Group A Cardiovascular Indications”); Group B – ***** (hereinafter “Group B Cardiovascular Indications”); and Group C — ***** (hereinafter “Group C Cardiovascular Indications”).
Sample 1Sample 2Sample 3

Examples of Cardiovascular Indications in a sentence

  • For the avoidance of doubt, this right of first negotiation shall apply to Cell Therapy for all indications within the Non-Licensed Cardiovascular Indications.

  • In its research and development activities in connection with Third Parties related to products for Cell Therapy outside of the Cardiovascular Indications, Athersys shall make Commercially Reasonable Efforts to position such products in a way that reduces the potential for such products to be used off label in any of the Cardiovascular Indications.

  • The Offer Notice shall specify the indications within the Non-Licensed Cardiovascular Indications to which the notice applies, and in the case of (c), shall summarize the terms of the Third Party’s offer.

  • Accordingly, Angiotech shall have the right of first and exclusive negotiation to obtain an exclusive license to Cell Therapy for all or any part of the Non-Licensed Cardiovascular Indications identified in the Negotiation Notice.

  • If Angiotech fails to deliver the Negotiation Notice prior to expiration of the Offer Period, or if Athersys and Angiotech are unable to consummate a mutually acceptable transaction prior to expiration of the Negotiation Period, Athersys shall be free to license Cell Therapy for the applicable Non-Licensed Cardiovascular Indications to a Third Party.

  • If Angiotech delivers such Negotiation Notice to Athersys, Athersys shall negotiate in good faith exclusively with Angiotech, for a period of not less than ninety (90) days from the date of Athersys’ receipt of the Negotiation Notice (the “Negotiation Period”), mutually acceptable, commercially reasonable terms and conditions of an exclusive license to Angiotech for the applicable Non-Licensed Cardiovascular Indications.

  • Athersys shall conduct, and shall be responsible for, the Pre-Clinical Development Programs in existence as of the Effective Date within the Cardiovascular Indications.

  • Except as expressly provided pursuant to a Clinical Development Plan or in any Transaction Agreement, during the Term Athersys shall not engage (itself or with a Third Party) in any clinical development or commercialization activities directed to the Cardiovascular Indications using any stem cells.

  • Save as provided above, we may terminate the Service at any time at our discretion with reasonable notice.

  • Upon Angiotech’s receipt of the Offer Notice, Angiotech shall have fifteen (15) days (the “Offer Period”) to notify Athersys that Angiotech desires to negotiate with Athersys to obtain a license for Cell Therapy for Table of Contents the applicable Non-Licensed Cardiovascular Indications (such notice by Angiotech is hereinafter referred to as the “Negotiation Notice”).

Related to Cardiovascular Indications

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • 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.

  • 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 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 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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • 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.

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

  • 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 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 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.

  • COVID-19 symptoms means fever of 100.4 degrees Fahrenheit or higher, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, or diarrhea, unless a licensed health care professional determines the person’s symptoms were caused by a known condition other than COVID-19.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

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

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • 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.

  • 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.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • 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.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • 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.