Common use of Regulatory Matters, Etc Clause in Contracts

Regulatory Matters, Etc. (i) The FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, or the manufacturing facilities therefore, that causes such Person the loss of more than ten percent (10%) of the Borrower’s revenue for the twelve (12) month period following such enforcement action as compared to the same period ending on the same date in the prior period, or (ii) any Obligor enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $500,000 to the extent not covered by insurance.

Regulatory Matters, Etc. (i) The FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, or the manufacturing facilities therefore, that causes such Person the loss of more than ten percent (10%) of the Borrower’s revenue for the twelve (12twelve(12) month period following such enforcement action as compared to the same period ending on the same date in the prior period, or (ii) any Obligor enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $500,000 to the extent not covered by insurance.