Define: Safety Issue

How is Safety Issue defined in a legal contract?

• Safety Issue means any emerging safety concern or any potential shift in the risk-benefit equilibrium of a drug, which includes information on a possibly causal connection between an adverse event and a drug, where the connection is previously unknown or not fully documented.
  Seen in 19 SEC filings.
• Safety Issue means any unexpected or negative event associated with a product that is reported by a patient or doctor, or of which a party becomes aware of. This event raises questions about patient safety or the effectiveness of the mentioned product and is thought to be significant enough for a party to contemplate immediate action concerning the product.
  Seen in 5 SEC filings.
• Safety Issue means any event, data, or information that could cause a reevaluation of product safety. This issue may include, but is not limited to, suspected adverse drug reactions and unexpected suspected adverse drug reactions.
  Seen in 5 SEC filings.

Please note, a number of other definitions have been excluded due to their specificity or reference to certain organizations, locations, or other restricted factors.

Note: The Genie AI Legal Assistant pulled this data out of the SEC EDGAR Database of 500,000 records from the past 22 years of filings. We regularly update this page as new filings and definitions come in.

Search EDGAR for ‘Definitions of safety issue’ yourself to verify these results. We are always keen to point people to source documents.

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Which definition should you use?

🤔 Our AI Legal Assistant has combined and improved the above descriptions to create market-standard 'Genie definitions' below, with guidance on which documents and which industry to use for each.

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Genie Definition 1

• Safety Issue means any event or information indicating a potential shift in risk-benefit balance of a drug or product due to unforeseen adverse events or emerging safety concerns.

Relevant Contract Types

• Product Licensing Agreement
• Clinical Trial Agreement

Relevant Circumstances

• Introduction of a new drug or product
• Change in production or formulation of a drug
• Incidents resulting in an adverse event during product usage
• Feedback or data suggesting a potential safety risk

Relevant Sectors

• Pharmaceutical
• Healthcare
• Cosmetics
• Medical Devices

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