Safety Issue definition

Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for the BMS Study Drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

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Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for a drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

Safety Issue means any unexpected or untoward adverse event related to a Product that is reported to a Party by a patient or physician, or about which a Party becomes aware, which event raises a question about patient safety or the efficacy of such Product and which event a Party considers to be serious enough to contemplate taking a prompt affirmative action with respect to such Product.

Examples of Safety Issue in a sentence

• BMS may terminate this Agreement immediately upon written notice to BioNTech if BMS determines that there is a Safety Issue with respect to a Licensed Product and such Safety Issue is not resolved to BMS’s satisfaction within [***] after BMS notifies the JSMT (or JSC or JDC) regarding such Safety Issue.

• At the written request of BioNTech (which request, if any, must be made within [***] following BMS’s notification of such Safety Issue to the JSMT (or JSC or JDC)), BMS and BioNTech shall confer (through the JSMT) regarding such Safety Issue (provided that such conference shall occur no later than [***] following such written request of BioNTech); provided that, for clarity, such conference shall in no way limit BMS’s right to terminate this Agreement pursuant to this Section 14.4.

More Definitions of Safety Issue

Safety Issue means instances, in which either the FDA or the EMA require that the Development, Manufacture, or Commercialization of a CoDev Product be stopped.

Safety Issue means any event, report, data or information, which could cause a re-evaluation of the safety of the Shire Product including, but not limited to, Suspected Adverse Drug Reaction and Unexpected Suspected Adverse Drug Reaction.

Safety Issue means, with respect to a given Collaboration Product or Other Component used in combination with such Collaboration Product: [***].

Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for the Novartis Study Drugs or Olema Study Drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

Safety Issue means, with respect to a Product, [**].

Safety Issue means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for the Other Party’s Compound, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

Safety Issue means a serious adverse event, toxicology finding or other serious safety issue or tolerability finding or issue with respect to a Licensed Product administered to humans that, as of the Effective Date, was not publicly known to be an adverse event, toxicology finding or other safety or tolerability finding or issue associated with positive allosteric modulators of GABA-A, as a class.