Expedited Reporting Responsibilities Clause Samples
The Expedited Reporting Responsibilities clause defines the obligation of parties to promptly report certain events or information, typically those that are urgent or have significant impact, such as adverse events in clinical trials or breaches in a business agreement. This clause usually sets specific timeframes for notification—often within a few days—and outlines the types of incidents that require expedited reporting, such as safety concerns or regulatory issues. Its core function is to ensure that critical information is communicated quickly, enabling timely responses and compliance with legal or regulatory requirements.
Expedited Reporting Responsibilities. Subject to Sections 7.6 to 7.10, Shire will be responsible for assessing the “reportability” and submitting reports of Serious Suspected Adverse Drug Reactions for the Product (according to current FDA regulations) to Duramed to be submitted to the Regulatory Authority.
Expedited Reporting Responsibilities. Subject to clauses 7.9 to 7.11, OA will be responsible, in the Territory, for assessing the “reportability” and submitting reports of Serious Adverse Reactions for the Product (according to current national regulations) to the relevant Registration Authorities.
Expedited Reporting Responsibilities. Subject to clauses 7.9 to 7.11, SOI will be responsible, in the Territory, for assessing the “reportability” and submitting reports of Serious Adverse Reactions for the Product (according to current national regulations) to VGN for filing with the relevant Registration Authorities. April 16, 2007
Expedited Reporting Responsibilities. Principal is responsible for expedited safety reporting to EMA, distributors responsible for expedited safety reporting to local regulatory authorities if required by any local regulatory authorities in the Territory. Distributor shall provide evidence of the submission at any time upon request from Principal.