Safety Notices. Neither any Credit Party nor any of its Subsidiaries has engaged in any Recalls, field notifications, warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action, including as a result of any Risk Evaluation and Mitigation Strategy proposed by the FDA, relating to an alleged lack of safety or regulatory compliance of the Products that could reasonably be expected to result in a Material Adverse Change.
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Samples: Loan Agreement (Epizyme, Inc.), Loan Agreement (Epizyme, Inc.)
Safety Notices. Neither Within the past three (3) years, neither any Credit Party nor any of its Subsidiaries has initiated or otherwise engaged in any Recallsrecalls, field notifications, safety warnings, “dear doctor” letters, investigator notices, safety alerts or other similar notices of action, including as a result of any Risk Evaluation and Mitigation Strategy proposed or enforced by the FDA, relating to an alleged lack of safety or regulatory compliance of the Products any Product that could reasonably be expected to result in a Material Adverse Change.
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Samples: Guaranty and Security Agreement (Sarepta Therapeutics, Inc.)
Safety Notices. Neither Within the past [**], neither any Credit Party nor any of its Subsidiaries has initiated or otherwise engaged in any Recallsrecalls, field notifications, safety warnings, “dear doctor” letters, investigator notices, safety alerts or other notices of action, including as a result of any Risk Evaluation and Mitigation Strategy proposed or enforced by the FDA, relating to an alleged lack of safety or regulatory compliance of the Products Product that could would reasonably be expected to result in a Material Adverse Change[**].
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