Common use of FDA Compliance Clause in Contracts

FDA Compliance. The Company and its subsidiaries are in compliance in all material respects with all applicable rules and regulations of the U.S. Food and Drug Administration (the “FDA”), and all related applicable laws, statutes, ordinances, rules or regulations (including, without limitation, the Federal Food, Drug and Cosmetic Act, as amended, the Biologic Products provisions of the Public Health Act, as amended, and the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended), the enforcement of which, individually or in the aggregate, would be expected to result in a Material Adverse Effect.

Appears in 6 contracts

Samples: Underwriting Agreement (Alnylam Pharmaceuticals, Inc.), Underwriting Agreement (Alnylam Pharmaceuticals, Inc.), Underwriting Agreement (Alnylam Pharmaceuticals, Inc.)

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FDA Compliance. The Company and its subsidiaries are is in compliance in all material respects with all applicable rules and regulations of the U.S. Food and Drug Administration (the “FDA”), and all related applicable laws, statutes, ordinances, rules or regulations (including, without limitation, the Federal Food, Drug and Cosmetic Act, as amended, the Biologic Products provisions of the Public Health Act, as amended, amended and the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amendedGood Manufacturing Practice regulations), the enforcement of which, individually or in the aggregate, would not be expected to result in have a Material Adverse Effect.

Appears in 2 contracts

Samples: Underwriting Agreement (Cleveland Biolabs Inc), Underwriting Agreement (Cleveland Biolabs Inc)

FDA Compliance. The Company and its subsidiaries are in compliance in all material respects with all applicable rules and regulations of the U.S. Food and Drug Administration (the "FDA"), and all related applicable laws, statutes, ordinances, rules or regulations (including, without limitation, the Federal Food, Drug and Cosmetic Act, as amended, the Biologic Products provisions of the Public Health Act, as amended, and the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended), the enforcement of which, individually or in the aggregate, would be expected to result in a Material Adverse EffectChange.

Appears in 1 contract

Samples: Underwriting Agreement (Alnylam Pharmaceuticals Inc)

FDA Compliance. The Company Company, and its subsidiaries are the manufacture, marketing, distribution and sales of the Company’s products and services, is in compliance in all material respects with all applicable rules and regulations of the U.S. Food and Drug Administration (the “FDA”), and all related applicable laws, statutes, ordinances, rules or regulations (including, without limitation, the Federal Food, Drug and Cosmetic Act, as amended, the Biologic Products provisions of the Public Health Act, as amended, and the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amendedGood Manufacturing Practice regulations), the enforcement of which, individually or in the aggregate, would be expected to result in a Material Adverse Effect.

Appears in 1 contract

Samples: Share Exchange Agreement (Sentient Brands Holdings Inc.)

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FDA Compliance. The Company and its subsidiaries are in compliance in all material respects with all applicable rules and regulations of the U.S. Food and Drug Administration (the “FDA”), and all related applicable laws, statutes, ordinances, rules or regulations (including, without limitation, the Federal Food, Drug and Cosmetic Act, as amended, the Biologic Products provisions of the Public Health Act, as amended, amended and the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amendedQuality Systems Regulations), the enforcement of which, individually or in the aggregate, would not be expected to result in have a Material Adverse Effect.

Appears in 1 contract

Samples: Underwriting Agreement (Alphatec Holdings, Inc.)

FDA Compliance. The Company and its subsidiaries are is in compliance in all material respects with all applicable rules and regulations of the U.S. Food and Drug Administration (the “FDA”), and all related applicable laws, statutes, ordinances, rules or regulations (including, without limitation, the Federal Food, Drug and Cosmetic Act, as amended, the Biologic Products provisions Radiation Control for Safety and Health Act of the Public Health Act1968, as amended, and the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amendedGood Manufacturing Practice regulations), the enforcement of which, individually or in the aggregate, would be expected to result in a Material Adverse EffectChange.

Appears in 1 contract

Samples: Underwriting Agreement (Intralase Corp)

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