Common use of FDA Matters Clause in Contracts

FDA Matters. (i) The FDA or any other Governmental Authority initiates enforcement action including but not limited to any inspection against any Credit Party or any of its Subsidiaries, or any suppliers that causes such Credit Party or Subsidiary to recall, withdraw, remove or discontinue manufacturing, shipping or marketing any of its Products the result of which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more or would reasonably be expected to have a Material Adverse Effect; (ii) the FDA requires Credit Party or its Subsidiaries to modify the label or labeling of any Product as a result of a safety or compliance risk, or seeks to restrict in any way, the distribution of any of Credit Party’s or its Subsidiaries’ Products, which would reasonably be expected, in the aggregate to have a Material Adverse Effect; (iii) the FDA or any other Governmental Authority issues a warning letter or other communication to any Credit Party or any of its Subsidiaries with respect to any Regulatory Matter which if not promptly resolved would reasonably be expected, in the aggregate, to have a Material Adverse Effect; (iv) any Credit Party or any of its Subsidiaries conducts a mandated or voluntary recall or market withdrawal which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more; or (v) any Credit Party or any of its Subsidiaries enters into a settlement agreement with the FDA or any other Governmental Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, of the FDA Trigger Amount or more, or that would reasonably be expected to have a Material Adverse Effect.

FDA Matters. Except as set forth on Annex III to Amendment No. 6, (i) The the FDA or any other Governmental Authority initiates enforcement action including but not limited to any inspection against any Credit Party or any of its Subsidiaries, or any suppliers that causes such Credit Party or Subsidiary to recall, withdraw, remove or discontinue manufacturing, shipping or marketing any of its Products the result of which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more or would reasonably be expected to have a Material Adverse Effect; (ii) the FDA requires Credit Party or its Subsidiaries to modify the label or labeling of any Product as a result of a safety or compliance risk, or seeks to restrict in any way, the distribution of any of Credit Party’s or its Subsidiaries’ Products, which would reasonably be expected, in the aggregate to have a Material Adverse Effect; (iii) the FDA or any other Governmental Authority issues a warning letter or other communication to any Credit Party or any of its Subsidiaries with respect to any Regulatory Matter which if not promptly resolved would reasonably be expected, in the aggregate, to have a Material Adverse Effect; (iv) any Credit Party or any of its Subsidiaries conducts a mandated or voluntary recall or market withdrawal which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more; or (v) any Credit Party or any of its Subsidiaries enters into a settlement agreement with the FDA or any other Governmental Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, of the FDA Trigger Amount or more, or that would reasonably be expected to have a Material Adverse Effect.

FDA Matters. Except as set forth on Annex III to Amendment No. 4, (i) The the FDA or any other Governmental Authority initiates enforcement action including but not limited to any inspection against any Credit Party or any of its Subsidiaries, or any suppliers that causes such Credit Party or Subsidiary to recall, withdraw, remove or discontinue manufacturing, shipping or marketing any of its Products the result of which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more or would reasonably be expected to have a Material Adverse Effect; (ii) the FDA requires Credit Party or its Subsidiaries to modify the label or labeling of any Product as a result of a safety or compliance risk, or seeks to restrict in any way, the distribution of any of Credit Party’s or its Subsidiaries’ Products, which would reasonably be expected, in the aggregate to have a Material Adverse Effect; (iii) the FDA or any other Governmental Authority issues a warning letter or other communication to any Credit Party or any of its Subsidiaries with respect to any Regulatory Matter which if not promptly resolved would reasonably be expected, in the aggregate, to have a Material Adverse Effect; (iv) any Credit Party or any of its Subsidiaries conducts a mandated or voluntary recall or market withdrawal which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more; or (v) any Credit Party or any of its Subsidiaries enters into a settlement agreement with the FDA or any other Governmental Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, of the FDA Trigger Amount or more, or that would reasonably be expected to have a Material Adverse Effect.