Common use of Regulatory Matters, Etc Clause in Contracts

Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other Regulatory Authority (whether U.S. or non-U.S.) initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Obligor to discontinue or withdraw, or could reasonably be expected to cause any Obligor to discontinue or withdraw, Product Development and Commercialization Activities with respect to any Product, or otherwise causes a delay in the manufacture or sale of any Product, which discontinuance or delay could reasonably be expected to last for more than 30 days, (ii) a recall of any Product that has generated or is expected to generate at least $2,000,000 in revenue for the Borrower and its Subsidiaries over any period of twelve consecutive months or (iii) 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 $750,000.

Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other Regulatory Authority (whether U.S. or non-U.S.) initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Obligor to discontinue or withdraw, or could reasonably be expected to cause any Obligor to discontinue or withdraw, Product Development and Commercialization Activities with respect to marketing or sales of any Product, or otherwise causes a delay in the manufacture or sale of any Product, which discontinuance or delay could reasonably be expected to last for more than 30 thirty (30) days, (ii) a recall of any Product that has generated or is expected to generate at least $2,000,000 2,500,000 in revenue for the Borrower and its Subsidiaries over any period of twelve (12) consecutive months or (iii) 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 $750,0002,500,000.

Regulatory Matters, Etc. If any of the following occurs: (i) the FDA or any other Regulatory Authority (whether U.S. or non-U.S.) initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, any Product or any manufacturing facilities for any Product that causes any Obligor to discontinue or withdraw, or could reasonably be expected to cause any Obligor to discontinue or withdraw, Product Development and Commercialization Activities with respect to any Product, or otherwise causes a delay in the manufacture or sale of any Product, which discontinuance or delay could reasonably be expected to last for more than 30 days, (ii) a recall of any Product that has generated or is expected to generate at least $2,000,000 5,000,000 in revenue for the Borrower and its Subsidiaries over any period of twelve consecutive months months, or (iii) 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 $750,0002,000,000.