definiens: means ( a ) the transfer to [COMPANY] or its designe e of all analytical methods used by or on behalf of [COMPANY] to demonstrate co nformity of Product with the Specifications, consis tent with the description of analytical method transfer set f orth in World Health Organization ( WHO ) ‘ WHO guidel ines on transfer of technology in pharmaceutical manufactur ing ’ ; and ( b ) the provision by [COMPANY] to PhaseBi o or its designee of reasonable assistance, and reasonable a ccess to [COMPANY] ’s technical and process experts to assist : ( i ) in the execution of the analytical method trans fer described in the preceding clause ( a ) ; and CONFIDENTIAL ( ii ) in reproducing the Manufacturing Process as pr acticed by [COMPANY] . Without limiting the foregoin g, such reasonable assistance shall include transfer of all processes, procedures, know - how and data required to Manufacture PB2452 bulk drug substance conforming t o the Specifications ( as in effect at the time of s uch transfer ) and in accordance with applicable Marketing Authori zations and Regulatory Authority guidelines