definiens: shall mean the activiti es by the Parties necessary to Manufacture the Prod uct for Client at the Facility or otherwise conduct the Ser vices, as further described in the applicable PSA a nd / or Project Plan which may include : ( i ) transfer of the Client Technology and Client Material from Client to SBL ; ( ii ) implementation of the Manufacturing Process at the Facility, including establishing a small scale Manu facturing Process model at SBL ; ( iii ) all Manufacturing Proce ss fit activities, including required small- and la rge - scale process development and validation work as allocate d between the Parties to SBL and process engineerin g required to modify / equip, qualify and validate th e Facility for the Manufacturing of the Commercial Product ; ( iv ) stability testing, if applicable, for the Prod uct required for licensure ; ( v ) comparability testi ng to the appropriate reference product, and ( vi ) regulatory support for all Regulatory Approvals, each as furth er described in the Project Plan