Material Safety Event definition

Material Safety Event means an event occurring after the Original Agreement Effective Date that is caused by a Licensed Product, or based on objective scientific or clinical evidence, is reasonably likely to be caused by a Licensed Product, and results in [***].
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Material Safety Event means an event that [***], is reasonably likely to [***] that (when considered in totality) is reasonably likely: (a) [***]; and/or (b) [***].
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Material Safety Event means a material safety event (whether as to the type of event or magnitude or severity of the safety issue) that arises prior to Completion of the Arvinas Clinical Trials Transfer and is reasonably likely to cause the continuation of the Arvinas Clinical Trial Activities to impose an unacceptable risk for patient safety.
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Examples of Material Safety Event in a sentence

  • In the event that a Material Safety Event occurs in connection with any Phase 2 Clinical Trial that Sanofi is conducting for [***], then Sanofi will have the right, at its sole election, to wind-down such Phase 2 Clinical Trial in accordance with Applicable Law.

  • In the event that a Material Safety Event occurs in connection with any Clinical Trials conducted by or on behalf of Kymera, then Xxxxxx will have the right, at its sole election, to wind-down such Clinical Trials in accordance with Applicable Law.

  • In addition, subject to this Section 13.6, Sanofi will have the right to terminate this Agreement with respect to an affected Program or Product (and any other Product containing the same Compound), upon [***] prior written notice to Denali, if as a result of a Material Safety Event, [***].

  • The terminating Party shall [***]For clarity, any termination pursuant to this Section 14.5 (Termination of Material Safety Event) with respect to one or more Licensed Products shall be subject to Section 14.3.4 (Termination of One or More Licensed Product(s)).

  • If Sanofi provides to Kymera a Material Safety Event Notice pursuant to Section 7.6.2, Sanofi may include in such notice (or deliver at any time [***] thereafter) a written notice of termination (a “Safety Termination”), which termination notice will be effective as of the date of its issuance.

  • Material Safety Event occurs with respect to such Collaboration Program; provided that the JSC unanimously agrees that a Material Safety Event has occurred as of the date of such written notice.

  • Sanofi will have the right to terminate this Agreement with respect to an affected Program or Product (and any other Product containing the same Compound), upon [***] prior written notice to Denali, if a Material Safety Event occurs or is identified by a Regulatory Authority [***].

  • Each Party shall immediately notify the other Party of (a) any Material Safety Event, and (b) any information it receives regarding any threatened or pending action, inspection or communication by any Regulatory Authority, which may affect the safety or efficacy claims of the Product.

  • Eng Tem, an elementary school teacher in Prey Veng province, related how a victim and former cadre in his village improved their relations by talking.

Related to Material Safety Event

  • 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.

  • Environmental Event shall have the meaning set forth in Section 12.2.1.

  • 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.

  • material hoist means a hoist used to lower or raise material and equipment, excluding passengers; "medical certificate of fitness" means a certificate contemplated in regulation 7(8);

  • Insured Environmental Event As defined in Section 3.07(d).

  • Material Action means to consolidate or merge the Company with or into any Person, or sell all or substantially all of the assets of the Company, or to institute proceedings to have the Company be adjudicated bankrupt or insolvent, or consent to the institution of bankruptcy or insolvency proceedings against the Company or file a petition seeking, or consent to, reorganization or relief with respect to the Company under any applicable federal or state law relating to bankruptcy, or consent to the appointment of a receiver, liquidator, assignee, trustee, sequestrator (or other similar official) of the Company or a substantial part of its property, or make any assignment for the benefit of creditors of the Company, or admit in writing the Company's inability to pay its debts generally as they become due, or take action in furtherance of any such action, or, to the fullest extent permitted by law, dissolve or liquidate the Company.

  • Significant deficiency means a shortcoming in the system that materially affects the ability of officials of the Department of Defense to rely upon information produced by the system that is needed for management purposes.

  • Material Environmental Liabilities means Environmental Liabilities exceeding $500,000 in the aggregate.

  • Material Environmental Amount an amount payable by the Borrower and/or its Subsidiaries in excess of $5,000,000 for remedial costs, compliance costs, compensatory damages, punitive damages, fines, penalties or any combination thereof.

  • Material Compliance Matter has the same meaning as the term defined in Rule 38a-1, and includes any compliance matter that involves: (1) a violation of the federal securities laws by Distributor (or its officers, directors, employees, or agents); (2) a violation of Distributor's Rule 38a-1 policies and procedures; or (3) a weakness in the design or implementation of Distributor's Rule 38a-1 policies and procedures.

  • Material of Environmental Concern means and includes pollutants, --------------------------------- contaminants, hazardous wastes, and toxic, radioactive, caustic or otherwise hazardous substances, including petroleum, its derivatives, by-products and other hydrocarbons, or any substance having any constituent elements displaying any of the foregoing characteristics.

  • 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.

  • Hazardous Material Activity means any activity, event or occurrence involving a Hazardous Material, including, without limitation, the manufacture, possession, presence, use, generation, transportation, treatment, storage, disposal, Release, threatened Release, abatement, removal, remediation, handling of or corrective or response action to any Hazardous Material.

  • Processes with Significant Environmental Aspects means the Equipment which, during regular operation or if not properly operated or maintained, may cause or are likely to cause an adverse effect.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Material Event or “Material Information” shall mean such event or information as set out in the Schedule or as may be determined in terms of Clause 3 of the Policy. In the Policy, the words, “material” and “materiality” shall be construed accordingly.

  • Material Events means any of the events listed in Section 3 of this Continuing Disclosure Undertaking.

  • Environmental Activity means any activity, event or circumstance in respect of a Contaminant, including, without limitation, its storage, use, holding, collection, purchase, accumulation, assessment, generation, manufacture, construction, processing, treatment, stabilization, disposition, handling or transportation, or its Release, escape, leaching, dispersal or migration into the natural environment, including the movement through or in the air, soil (land surface or subsurface strata), surface water or groundwater;

  • Material Project means the construction or expansion of any capital project of the Borrower or any of its Subsidiaries, the aggregate capital cost of which exceeds $50,000,000.

  • Regulatory Event means, following the occurrence of a Change in Law (as defined below) with respect to the Issuer and/or Société Générale as Guarantor or in any other capacity (including without limitation as hedging counterparty of the Issuer, market maker of the Certificates or direct or indirect shareholder or sponsor of the Issuer) or any of its affiliates involved in the issuer of the Certificates (hereafter the “Relevant Affiliates” and each of the Issuer, Société Générale and the Relevant Affiliates, a “Relevant Entity”) that, after the Certificates have been issued, (i) any Relevant Entity would incur a materially increased (as compared with circumstances existing prior to such event) amount of tax, duty, liability, penalty, expense, fee, cost or regulatory capital charge however defined or collateral requirements for performing its obligations under the Certificates or hedging the Issuer’s obligations under the Certificates, including, without limitation, due to clearing requirements of, or the absence of, clearing of the transactions entered into in connection with the issue of, or hedging the Issuer’s obligation under, the Certificates, (ii) it is or will become for any Relevant Entity impracticable, impossible (in each case, after using commercially reasonable efforts), unlawful, illegal or otherwise prohibited or contrary, in whole or in part, under any law, regulation, rule, judgement, order or directive of any governmental, administrative or judicial authority, or power, applicable to such Relevant Entity (a) to hold, acquire, issue, reissue, substitute, maintain, settle, or as the case may be, guarantee, the Certificates, (b) to acquire, hold, sponsor or dispose of any asset(s) (or any interest thereof) of any other transaction(s) such Relevant Entity may use in connection with the issue of the Certificates or to hedge the Issuer’s obligations under the Certificates,(c) to perform obligations in connection with, the Certificates or any contractual arrangement entered into between the Issuer and Société Générale or any Relevant Affiliate (including without limitation to hedge the Issuer’s obligations under the Certificates) or (d) to hold, acquire, maintain, increase, substitute or redeem all or a substantial part of its direct or indirect shareholding in the Issuer’s capital or the capital of any Relevant Affiliate or to directly or indirectly sponsor the Issuer or any Relevant Affiliate, or (iii) there is or may be a material adverse effect on a Relevant Entity in connection with the issue of the Certificates.

  • Initial Environmental Examination or “IEE” means an initial environmental examination for a Subproject, including any update thereto, prepared and submitted by the Borrower pursuant to the requirements set forth in the EARF and cleared by ADB;

  • Environmental Clean-up Site means any location which is listed or proposed for listing on the National Priorities List, the Comprehensive Environmental Response, Compensation and Liability Information System, or on any similar state list of sites relating to investigation or cleanup, or which is the subject of any pending or threatened action, suit, proceeding, or investigation related to or arising from any location at which there has been a Release or threatened or suspected Release of a Hazardous Material.

  • Potential Material Event means any of the following: (i) the possession by the Company of material information not ripe for disclosure in the Registration Statement, which shall be evidenced by determinations in good faith by the Board of Directors of the Company that disclosure of such information in the Registration Statement would be detrimental to the business and affairs of the Company, or (ii) any material engagement or activity by the Company which would, in the good faith determination of the Board of Directors of the Company, be adversely affected by disclosure in the Registration Statement at such time, which determination shall be accompanied by a good faith determination by the Board of Directors of the Company that the Registration Statement would be materially misleading absent the inclusion of such information.

  • Natural radioactivity means radioactivity of naturally occurring nuclides.

  • Controlled substance means a controlled substance in schedules I through V of Section 202 of the Controlled Substances Act (2l U.S.C. 8l2) and as further defined in regulation at 2l CFR l308.ll-l308.l5.