FDA Violation Notices Sample Clauses
The FDA Violation Notices clause requires parties to promptly inform each other if they receive any notice or communication from the U.S. Food and Drug Administration (FDA) regarding violations related to the products or services covered by the agreement. In practice, this means that if one party is notified by the FDA about non-compliance, recalls, or other regulatory issues, they must notify the other party within a specified timeframe and may need to provide relevant documentation. This clause ensures transparency and allows both parties to address regulatory issues proactively, minimizing legal and operational risks associated with FDA enforcement actions.
FDA Violation Notices. Promptly, and in any event within 5 Business Days after any Credit Party has Knowledge of any material violation, claim, complaint, charge or receipt of any material violation, claim, complaint or charge of or under the Food and Drug Act or any material applicable statutes, rules, regulations, guidelines, policies orders or directives administered or issued by the FDA, including without limitation receipt by any Credit Party or any of its Subsidiaries of any Product Recall Notice, other FDA notice satisfying the foregoing materiality standard or amendment to such a previous Product Recall Notice or FDA notice that is required to be disclosed under this Section 5.1(m), a statement of an Authorized Officer setting forth the material details of such occurrence and the actions, if any, which such Credit Party proposes to take with respect thereto and in the case of a written document evidencing such event, together with a true, correct and complete copy of such Product Recall Notice, FDA Notice or amendment or other notice, as the case may be (other than to the extent that provision of such documents or information to the Agents and the Lenders would invalidate any privileged status granted by such Governmental Authority with respect to such documents or information, in which case, the Credit Parties shall furnish a summary of the documents or information so provided that does not invalidate such privilege);