Quality Testing. CTI shall perform quality control --------------- tests and assays on all Collaboration Compounds in accordance with the specifications. Furthermore, CTI shall provide ORTHO with a Certificate of Analysis and a Certificate of Compliance for each batch of Collaboration Compound delivered to ORTHO. The Certificate of Compliance shall certify that each batch was reviewed and meets all regulatory requirements. The Certificate of Analysis shall certify that each batch was tested and meets all specifications. CTI shall permit ORTHO's designated representatives to inspect and visit from time to time the facilities at which Collaboration Compounds are manufactured, stored or tested for the purpose of determining compliance with this Agreement, as well as all pertinent regulatory requirements. Such inspections shall occur during regular business hours upon reasonable notice.
Appears in 2 contracts
Sources: Collaboration and License Agreement (Cell Therapeutics Inc), Collaboration and License Agreement (Cell Therapeutics Inc)