DMF. Alliance shall be responsible for all testing and document generation (including without limitation all facilities information and related documentation; chemistry, manufacturing, and control information; regulatory methods and controls; assays and reference standards) necessary for filing a drug master file ("DMF") with the FDA for the production of the drug substance from which each Product is formulated. Alliance shall also be responsible for filing such DMF with the FDA for the production of the drug substance from which each Product is formulated. Alliance shall use reasonable efforts to defend the DMF information as required by the FDA in order to permit Schering to maintain approval of the Drug Approval Application in which such DMF is incorporated by reference.
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Sources: License Agreement (Alliance Pharmaceutical Corp), License Agreement (Alliance Pharmaceutical Corp)
DMF. Alliance shall be responsible for all testing and document generation (including without limitation all facilities information and related documentation; chemistry, manufacturing, and control information; regulatory methods and controls; assays and reference standards) necessary for filing a drug master file ("DMF") with the FDA for the production of the drug substance from which each Product is formulated. Alliance shall also be responsible for filing such DMF with the FDA for the production of the drug substance from which each Product is formulated. Alliance shall use reasonable efforts to defend the DMF information as required by the FDA in order to permit Schering to maintain approval of the Drug Approval Application in which such DMF is incorporated by reference.
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