Serious Safety Issue definition

Serious Safety Issue means any SUSAR, or any dose-limiting toxicity, or series of SUSARs directly related to or caused by the administration of the Product in the conduct of a Product Clinical Trial where such SUSAR, series of SUSARs, or toxicity substantially diminishes the probability of receiving Regulatory Approval for the Product, or results in a Regulatory Authority imposing a Clinical Hold on further development of the Product which Clinical Hold is not lifted or removed within one hundred eighty (180) days.
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Serious Safety Issue means any SUSAR or series of SUSARs directly related to or caused by the administration of the Product in the conduct of the Clinical Trials where such SUSAR or series of SUSARs substantially diminishes the probability of receiving Regulatory Approval for the Product, or results in a Regulatory Authority imposing a clinical hold on further development of the Product which clinical hold is not lifted or removed within [***].
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Serious Safety Issue means any SUSAR or series of SUSARs directly related to or caused by the administration of a Product in the conduct of a Product Clinical Trial where [***].
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Examples of Serious Safety Issue in a sentence

  • Apellis will report to the JSC any Serious Safety Issue for which reporting is required under this provision.

  • Opthea will, within [***], report to the JSC any Serious Safety Issue with respect to (a) Product Clinical Trial subjects, or (b) individuals otherwise exposed to the Product, whether alone or in combination with Aflibercept or Ranibizumab.

  • Reata will promptly inform BXLS of any Serious Safety Issue following its awareness of the same.

  • CymaBay represents and warrants that, up to and as at the Effective Date, after due inquiry to its CRO responsible for conducting the Product Clinical Trials, CymaBay has not received any verbal or written notice of the occurrence of any Serious Safety Issue in the Product Clinical Trials.

  • PB hereby represents and warrants that, up to and as at the Effective Date, after due inquiry to its CRO responsible for conducting the Clinical Trials, PB has not received any verbal or written notice of the occurrence of any Serious Safety Issue in the Clinical Trials.

  • Qualifying foreign non-individual investors received their distributions after deduction of tax at the rate of 10%.

  • Nektar hereby represents and warrants that, up to and as at the Effective Date, after due inquiry to its CRO responsible for conducting the Clinical Trials, Nektar has not received any verbal or written notice of the occurrence of any Serious Safety Issue in the Clinical Trials.

  • Up to and as at the Effective Date, after due inquiry to all applicable CROs responsible for conducting the Product Clinical Trials, Opthea has not received any verbal or written notice of the occurrence of any Serious Safety Issue in the Product Clinical Trials.

  • Apellis hereby represents and warrants that, up to and as at the Effective Date, after due inquiry to its CRO responsible for conducting the Trial, Apellis has not received any verbal or written notice of the occurrence of any Serious Safety Issue in the Trial.

  • Up to and as at the Restatement Effective Date, after due inquiry to all applicable CROs responsible for conducting the Product Clinical Trials, Opthea has not received any verbal or written notice of the occurrence of any Serious Safety Issue in the Product Clinical Trials.

Related to Serious Safety Issue

  • Imminent safety hazard means an imminent and unreasonable risk of death or severe personal injury.

  • Imminent danger to the health and safety of the public means the existence of any condition or practice, or any violation of a permit or other requirement of this article, in a surface coal mining and reclamation operation which could reasonably be expected to cause substantial physical harm to persons outside the permit area before such condition, practice, or violation can be abated. A reasonable expectation of death or serious injury before abatement exists if a rational person, subjected to the same conditions, or practices giving rise to the peril, would not expose himself to the danger during the time necessary for abatement.

  • Safety zone means the area officially set apart within a roadway for the exclusive use of

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;

  • Imminent health hazard means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on the number of potential injuries and the nature, severity, and duration of the anticipated injury or illness.

  • Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);

  • Serious traffic violation means a conviction when operating a commercial motor vehicle of:

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Occupational Safety and Health Law means any Legal Requirement designed to provide safe and healthful working conditions and to reduce occupational safety and health hazards, including the Occupational Safety and Health Act, and any program, whether governmental or private (such as those promulgated or sponsored by industry associations and insurance companies), designed to provide safe and healthful working conditions.

  • Environmental, Health and Safety Laws means the Comprehensive Environmental Response, Compensation and Liability Act of 1980, the Resource Conservation and Recovery Act of 1976, and the Occupational Safety and Health Act of 1970, each as amended, together with all other laws (including rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings, and charges thereunder) of federal, state, local, and foreign governments (and all agencies thereof) concerning pollution or protection of the environment, public health and safety, or employee health and safety, including laws relating to emissions, discharges, releases, or threatened releases of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes into ambient air, surface water, ground water, or lands or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of pollutants, contaminants, or chemical, industrial, hazardous, or toxic materials or wastes.

  • Health and Safety Laws means all applicable laws, statutes, regulations, subordinate legislation, bye-laws, common law and other national, international, federal, European Union, state and local laws, judgments, decisions and injunctions of any court or tribunal, and codes of practice and/or guidance notes issued by any applicable government body or authority, public body, trade union, works council, or industry or regional sector authority to the extent that they relate to or apply to the health and safety of any person, including (but not limited to) any such requirements and obligations concerning Covid-19.

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • Safety Consultant shall have the meaning set forth in Clause 10.1;

  • Health and Safety Plan means a documented plan which addresses hazards identified and includes safe work procedures to mitigate, reduce or control the hazards identified;

  • serious criminal offence means an offence which corresponds or is equivalent to one of the offences referred to in Article 2(2) of Framework Decision 2002/584/JHA, if it is punishable under national law by a custodial sentence or a detention order for a maximum period of at least three years;

  • Serious Medical Condition means, for the purpose of interpreting Overseas Emergency Medical Evacuation and Repatriation cover, a condition which in the opinion of the Company or its authorised representatives constitutes a serious or life threatening medical emergency requiring immediate evacuation to obtain urgent remedial treatment in order to avoid death or serious impairment to an Insured Person’s immediate or long-term health prospects. The seriousness of the medical condition will be judged within the context of the Insured Person’s geographical location and the local availability of appropriate medical care or facilities.

  • Dangerous drug means any of the following:

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Health and Safety means, in relation to a recipient or a third person, the prevention of death or serious personal injury;

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • Flying bug insecticide means any insecticide product that is designed for use against flying insects or other flying arthropods, including but not limited to flies, mosquitoes, moths, or gnats. “Flying Bug Insecticide” does not include “wasp and hornet insecticide”, products that are designed to be used exclusively on humans or animals, or any moth-proofing product. For the purposes of this definition only, “moth-proofing product” means a product whose label, packaging, or accompanying literature indicates that the product is designed to protect fabrics from damage by moths, but does not indicate that the product is suitable for use against flying insects or other flying arthropods.

  • Traffic infraction means a violation of law punishable as provided in § 46.2-113, which is neither a

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Rail Safety Act means the Rail Safety Act 1998 (WA);

  • Serious assault means an act that constitutes a felony violation of chapter XI of the Michigan penal code, 1931 PA 328, MCL 750.81 to 750.90h, or that constitutes an assault and infliction of serious or aggravated injury under section 81a of the Michigan penal code, 1931 PA 328, MCL 750.81a.

  • Safety-sensitive function means all time from the time a driver begins to work or is required to be in readiness to work until the time he/she is relieved from work and all responsibility for performing work.