Drug Master File. XXXXXX shall file and maintain the appropriate Drug Master File (“DMF”) and related reference applications (e.g. Site Master File) for its Production of each Product hereunder in accordance with 21 CFR 314.420, as may be amended from time to time, and other regulatory requirements or required by Regulatory Authorities at XXXXXX’x expense.
Appears in 2 contracts
Samples: Commercial Supply Agreement (Amylin Pharmaceuticals Inc), Commercial Supply Agreement (Amylin Pharmaceuticals Inc)
Drug Master File. In accordance with the Product Master Plan, XXXXXX shall file and maintain the appropriate Drug Master File (“"DMF”") and related reference applications (e.g. Site Master File) for its Production of each Product hereunder in accordance with 21 CFR 314.420, as may be amended from time to time, and other regulatory requirements or required by Regulatory Authorities at XXXXXX’x XXXXXX'x expense.
Appears in 2 contracts
Samples: Commercial Supply Agreement (Idec Pharmaceuticals Corp / De), Commercial Supply Agreement (Idec Pharmaceuticals Corp / De)
Drug Master File. XXXXXX Xxxx shall file and maintain the appropriate Drug Master File (“DMF”) and related reference applications (e.g. Site Master FileFacility master file) for its Production of each Product hereunder in accordance with 21 CFR 314.420, or European equivalents of such guidelines and regulations, as may be amended from time to time, at Xxxx’x expense, and other regulatory requirements or required by Regulatory Authorities at XXXXXX’x expenseXxxx shall provide all needed rights of reference to Dyax for the fee set forth in a Work Order.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Dyax Corp), Services Agreement (Dyax Corp)
Drug Master File. XXXXXX Xxxxxx shall file and maintain the appropriate Drug Master File (the “DMF”) and related reference applications (e.g. Site Master File) for its Production of each Product hereunder in accordance with 21 CFR 314.420, as may be amended from time to time, and other regulatory requirements or required by Regulatory Authorities at XXXXXX’x Xxxxxx’x expense.
Appears in 1 contract
Samples: Manufacturing and Supply Agreement (Dynavax Technologies Corp)