definiens: ), [ * * * ] . [ * * * ] ( ( defined below ) will serve as [ * * * ] for Product for use in the Initial Phase I Study [ * * * ] for such Initial Phase I Study . [ * * * ] will be respo nsible for manufacture of all other clinical suppli es of the Product for use under the GDP ( a ) in the United Sta tes through clearance of the pre - approval inspectio n of [ * * * ] ( defined below ) in connection with the first Market ing Approval of the Initial Product in the U.S., an d ( b ) in the [COMPANY] Territory through clearance of the pre - appr oval inspection of [ * * * ] ( defined below ) in connect ion with the first Marketing Approval of the Initial Product for a [ * * * ] responsibility for manufacture and sup ply of Product for clinical and commercial use in the U.S