FDA Regulatory Matters. (a) The Company has developed, tested, manufactured and stored, as applicable, its product candidates, including the Products, in compliance in all material respects with Federal Food, Drug and Cosmetic Act of 1938, as amended, to the extent applicable, and applicable regulations issued by the FDA.
Appears in 4 contracts
Samples: Agreement and Plan of Merger (Endo Pharmaceuticals Holdings Inc), Agreement and Plan of Merger (Perceptive Advisors LLC), Agreement and Plan of Merger (Penwest Pharmaceuticals Co)