Regulatory Authorizations & cGMP Compliance. 1.1 Maintain all licenses, registrations and other authorizations as are required to operate a cGMP pharmaceutical manufacturing facility under the Applicable Laws. X 1.2 Maintain and operate the Facility in compliance with the cGMPs, Applicable Laws and all other Product-specific instructions and requirements agreed to by the Parties. X
Appears in 3 contracts
Samples: Commercial Supply Agreement (Horizon Therapeutics Public LTD Co), Commercial Supply Agreement (Horizon Pharma PLC), Commercial Supply Agreement (Horizon Pharma PLC)