definiens: means a technology transfer of Sutro ’s know - how and information as isnecessary or useful for the Third Party CMO to Manufacture in its own facilities Extract that meets [COMPANY] ’ requirements, including any suchinformation and know - how as would be needed for such CMO to scale up such Manufacture to the requested commercial volumes . Toestablish means that the CMO would take such actions as are necessary ( including validation and if necessary adapting orreserving existing facilities, establishing new facilities and/or procuring necessary equipment ) to Manufacture Extract meeting SutroVax’requirements for Phase 3 and commercial supply in such quantities as [COMPANY] designates . It is understood that [COMPANY] may request thatthe Process Transfer and establishment of Capacity be undertaken in separate steps, for example by undertaking an initial Process Transferto demonstrate the CMO ’s ability to Manufacture Extract, and then later establishing Capacity for Phase 3 and commercial supply, asrequested by [COMPANY] in accordance with Section 2.15.1(a ) ( i.e., in separate requests )