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