definiens: or means all activities related to the manufacturing of the Bulk Product, DrugSubstance, or any ingredient thereof, including manufacturing for clinical use or commercial sale, in - process and BulkProduct or Drug Substance testing, quality assurance and quality control required for release of the Product in the Field ( whichare initially as required for release of the Product in the Field in the U.S., as such 7CONFIDENTIALEXECUTION VERSION quality assurance and quality control requirements may be changed from time to time pursuant to the terms of this Agreementand / or the Quality Agreements ), handling and storage of Bulk Product or Drug Substance and ongoing stability tests andregulatory activities related to any of the foregoing ; provided, however, that for purposes of clarity shallinclude fill and lyophilization of Drug Substance but shall exclude Packaging and Labeling ( whether in commercial orclinical packaging presentation ) . For clarity, Manufacturing shall exclude Manufacturing Development Activities andTerritory - Specific Analytical Release Testing and Characterization