definiens: - 32 - means ( a ) each individual sequence submitted in its entirety, unaltered from the original submission, including : ( i ) full folder structure of each individual sequence, ( ii ) portable document format ( ) all documents submitted within that sequence, an d ( iii ) all extensible markup language ( ) documents submitted in that sequence ; ( b ) docume ntation submitted to or received from, and oral or written correspond ence with, any Regulatory Authorities or Governmental Authorities related to the Licensed Pr oducts and any companion diagnostic, including meeting minutes, notes pertaining to form al or informal discussions, electronic mail correspondence, telephone conversation records, Reg ulatory Submissions, and communications related to Clinical Trials, Development, and Manufa cturing, and ( c ) all technical information relating to the Licensed Products that uniQure has in its possession and that is required to be submitted to a Regulatory Authority for the purpose of obtaining any Regulatory Approval of the Licensed Products . The Parties will review and discuss the detailed timeline and each Party ’s roles and responsibilities through the JSC and will consult with applicable Regulatory Authorities regarding such assignment and transfer sufficiently in advance thereof