Common use of REPORTING OUTSIDE THE TERRITORY Clause in Contracts

REPORTING OUTSIDE THE TERRITORY. Cubist shall be responsible for reporting to the FDA and Regulatory Authorities outside of the Territory any adverse experience and safety issues for Licensed Products in compliance with the requirements of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. Section 321 et seq., the regulations promulgated thereunder, and the equivalent laws, rules and regulations in countries other than the United States outside of the Territory, and shall promptly thereafter provide to Chiron a copy of such report.

Appears in 2 contracts

Samples: Manufacturing and Supply Agreement (Cubist Pharmaceuticals Inc), License Agreement (Cubist Pharmaceuticals Inc)

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REPORTING OUTSIDE THE TERRITORY. Cubist shall be responsible for reporting to the FDA and Regulatory Authorities outside of the Territory any adverse experience and safety issues for Licensed Products in compliance with the requirements of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. Section §321 et seq., the regulations promulgated thereunder, and the equivalent laws, rules and regulations in countries other than the United States outside of the Territory, and shall promptly thereafter provide to Chiron a copy of such report.

Appears in 2 contracts

Samples: License Agreement (Cubist Pharmaceuticals Inc), License Agreement (Cubist Pharmaceuticals Inc)

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REPORTING OUTSIDE THE TERRITORY. Cubist shall be responsible for reporting to the FDA and Regulatory Authorities outside of the Territory any adverse experience and safety issues for Licensed Products in compliance with the requirements of the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. Section 321 et seq., the regulations promulgated thereunder, and the equivalent laws, rules and regulations in countries other than the United States outside of the Territory, and shall promptly thereafter provide to Chiron a copy of such report.. (c)

Appears in 1 contract

Samples: Confidential Treatment Manufacturing and Supply Agreement

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