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 initiates enforcement action against, or issues a warning letter with respect to, any Obligor, any Product or any manufacturing facilities that any Obligor owns or controls related to the foregoing that (x) causes any Obligor to discontinue or withdraw, or would reasonably be expected to cause any Obligor to discontinue or withdraw, marketing or sales of a Product or causes a delay in the manufacture or sale of a Product and (y) would reasonably be expected to result in a Material Adverse Effect, or (ii) a recall of a Product that would reasonably be expected to result in a Material Adverse Effect.

Regulatory Matters, Etc. If any of the following occurs:(ioccurs: (i) the FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any ObligorObligor or, to the knowledge of the Obligors, any Material Product or any manufacturing facilities that any Obligor owns or controls related to the foregoing that (x) causes any Obligor to discontinue or withdraw, or would could reasonably be expected to cause any Obligor to discontinue or withdraw, marketing or sales of a Product any Material Product, or causes a material delay in the manufacture or sale of a Product any Material Product, and (y) would could reasonably be expected to result in a Material Adverse Effect, or (ii) a recall of a any Material Product that would could reasonably be expected to result in a Material Adverse Effect.