Major Safety Issue definition

Major Safety Issue means, with respect to a Product, any of the following: (a) an adverse safety profile of a Product, or receipt or generation by a Party of any safety, tolerability or other data, indicating, as measured by safety and efficacy evaluation criteria and methodology customarily used by a majority of clinicians conducting studies on similar products for the same or substantially the same Indication as being pursued by such Party for such Product in the applicable country or Region, that such Product has or is reasonably likely to have serious risks for medical applications in humans to require a recall, withdrawal, or similar action; or (b) any notice, information or correspondence received by a Party from [***], or any action taken by any such Regulatory Authority, in each case, indicates that Regulatory Approval is reasonably unlikely to be granted therefor or, if already granted, the Regulatory Approval therefor would reasonably likely be revoked, or causes the Regulatory Approval therefor not to be granted or, if already granted, to be revoked.
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Major Safety Issue means, with respect to the Product, any of the following: (a) an adverse safety profile of the Product, or receipt or generation by a Party of any safety, tolerability or other data, indicating or signaling, as measured by safety and efficacy evaluation criteria and methodology customarily used by a majority of clinicians conducting studies on similar products in the applicable region or country, that the Product has or would have serious enough risks for medical applications in humans to require a recall, withdrawal, or similar action; or (b) any notice, information or correspondence received by a Party from a Regulatory Authority, or any action taken by a Regulatory Authority, in each case, that would reasonably be expected to result in Regulatory Approval not being granted therefor or, if already granted, the Regulatory Approval therefor being revoked or materially and adversely amended, or causes the Regulatory Approval therefor not to be granted or, if already granted, to be revoked or materially and adversely amended.
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Major Safety Issue means, with respect to a Product, any of the following: (a) an adverse safety profile of a Product, or receipt or generation by a Party of any safety, tolerability or other data, indicating or signaling, as measured by safety and efficacy evaluation criteria and methodology customarily used by a majority of clinicians conducting studies on similar products in the applicable region (including Region) or country (including Country), that such Product has or would have serious risks for medical applications in humans to require a recall, withdrawal, or similar action; or (b) any notice, information or correspondence received by a Party from a Regulatory Authority, or any action taken by a Regulatory Authority, in each case, indicates that Regulatory Approval is unlikely to be granted therefor or, if already granted, the Regulatory Approval therefor would likely be revoked or materially amended, or causes the Regulatory Approval therefor not to be granted or, if already granted, to be revoked or materially amended. In the event that MacroGenics, its Affiliates and their sublicensees of such Product discontinue the global Development, Manufacturing and Commercialization of such Product as a result of events or circumstances of the type described in (a) and/or (b) of this Section 1.93, such discontinuance shall be conclusive evidence that such events or developments are Major Safety Issues.
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Examples of Major Safety Issue in a sentence

  • If AMAG [***] determines [***] that there is a Major Safety Issue with respect to the Product, it shall notify Norgine that it intends to stop Developing and/or Commercializing the Product and as a result intends to stop supplying Norgine with clinical or commercial quantities of the Product (as applicable) pursuant to the then-applicable Supply Agreement.

  • Following notification by AMAG of its determination of a Major Safety Issue, AMAG’s supply obligations under Sections 5.1 and 5.2 shall no longer apply.

  • This Agreement may be terminated in its entirety or on a Product-by-Product or region-by-region basis by either Party upon [***] written notice to the other Party if it reasonably determines in good faith that there is a Major Safety Issue with respect to a Product.


More Definitions of Major Safety Issue

Major Safety Issue means, with respect to a Product, any of the following: (a) an [***] of a Product, or receipt or generation by a Party of any [***] or other data, indicating or signaling, as measured by [***] and methodology customarily used by a majority of clinicians conducting studies on similar products in the applicable region (including Region) or country (including Country), that such Product has or would have serious enough risks for medical applications in humans to require a [***]; or (b) any notice, information or correspondence received by a Party from a Regulatory Authority, or any action taken by a Regulatory Authority, in each case, indicates that [***] or, if [***], the [***] therefor would [***], or causes the [***] or, if [***], to be [***].
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Major Safety Issue means, with respect to a collaboration product, any of the following: (a) an adverse safety profile of such collaboration product, or receipt or generation by a party of any safety, tolerability, or other data indicating or signaling, as measured by safety and efficacy evaluation criteria and methodology customarily used by a majority of clinicians conducting studies on similar products in the applicable jurisdiction, that such collaboration product has or would have serious risks for medical applications in humans to require a recall, withdrawal, or similar action; or (b) any notice, information or correspondence received by a party from a regulatory authority, or any action taken by a regulatory authority, in each case, indicates that regulatory approval is unlikely to be granted therefor or, if already granted, the regulatory approval therefor would likely be revoked or materially amended, or causes the regulatory approval therefor not to be granted or, if already granted, to be revoked or materially amended.
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Related to Major Safety Issue

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

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

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

  • 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;

  • Safety Management Certificate has the meaning given to it in the ISM Code.

  • 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.

  • 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;

  • Disturbance Control Standard or “DCS” shall mean the reliability standard that sets the time limit following a disturbance within which a balancing authority must return its Area Control Error to within a specified range.

  • 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 Management System means a systematic approach to managing safety, including the necessary organisational structures, accountabilities, policies and procedures;

  • Aerial applicator means aircraft or rotorcraft used exclusively for the purpose of

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • 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.

  • Grievance System means the overall system that includes:

  • Safety Requirements means Prudent Electrical Practices, CPUC General Order No. 167, Contractor Safety Program Requirements, and all applicable requirements of Law, PG&E, the Utility Distribution Company, the Transmission Provider, Governmental Approvals, the CAISO, CARB, NERC and WECC.

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Department sample means liquor that is placed in the possession of the

  • Safety Standards means all laws, union rules and trade or industry custom or codes of any kind whatsoever, in effect from the date of this Agreement through Final Acceptance of the construction work, pertaining to worker safety and accident prevention applicable to the Project and/or the construction work (including, but not limited to, rules, regulations and standards adopted pursuant to the Occupational Safety and Health Act of 1970, as amended from time to time).

  • Radiation safety officer means an individual who has the knowledge and responsibility to apply appropriate radiation protection regulations and has been assigned such responsibility by the licensee or registrant.

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • 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.

  • EPA means the United States Environmental Protection Agency.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Floodproofing means any combination of structural and nonstructural additions, changes, or adjustments to structures which reduce or eliminate flood damage to real estate or improved real property, water and sanitation facilities, structures, and their contents.

  • MHLW means the Japanese Ministry of Health, Labour and Welfare, and any successor agency thereto.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.