Common use of Custom Production Suite Clause in Contracts

Custom Production Suite. 3.3.1 Following approval of the Phase II Production Plan by the Parties, CBSW will propose a design and engineering team consisting of CBSW and Client personnel, along with outside consultants with expertise in the construction of cell therapy clean room facilities, and CBSW will submit a list of such members to Client for approval, which approval will not be unreasonably withheld. CBSW will retain the approved team (the "D&E Team") to create design and engineering plans for the Custom Production Suite based on the requirements set forth in the Phase II Production Plan. Such plans will include an estimate of costs relating to the construction and validation of the Custom Production Suite. Upon completion of such plans, the D&E Team will present its proposal to the Parties for approval. CBSW will bear all costs and expenses relating to any activities performed by the D&E Team in connection with the design and engineering of the Custom Production Suite. 3.3.2 The Client will pay [***] of the Custom Production Suite construction costs in an amount corresponding to [***] of the estimated costs set forth in such approved plans for the construction and validation of the Custom Production Suite, provided, however, that the amount of such payment will not exceed [***] (such payment, the "Construction Fee"). The Construction Fee will be paid by Client in [***] installments as follows: [***] of the Construction Fee shall be paid within [***] days after [***] (the "[***] "); an additional [***] of the Construction Fee shall be paid [***]; the remaining [***] of the Construction Fee shall be paid in [***] equal monthly installments [***]. 3.3.3 CBSW will, at its sole expense, use reasonable efforts to assure that construction of the Custom Production Suite meets the specifications and the schedule set forth in the Phase II Production Plan. As of the Effective Date, the Parties anticipate that final commissioning and validation of the Custom Production Suite will be complete within [***] following approval of the Phase II Production Plan and the final design and engineering plans for the Custom Production Suite by the Parties. CBSW will have sole decision-making authority over the management of Custom Production Suite construction and validation. CBSW will own the Custom Production Suite, including any equipment therein, and will maintain the Custom Production Suite in a manner consistent with regulatory guidelines and CBSW's maintenance of other suites at the Facility. The Custom Production Suite shall be used exclusively for manufacture of the Product during the Term of this Agreement. 3.3.4 If CBSW is unable to provide the Custom Production Suite pursuant to the Phase II Production Plan, then instead of providing the Custom Production Suite, CBSW will, in addition to refunding to Client the portion of the Construction Fee paid by Client, continue to provide the Production Suite used in Phase I and provide an additional pre-existing Production Suite (the "Additional Production Suite") at the Facility , both to be used exclusively for manufacture of the Product during the Terms of this Agreement. The Production Suite used in Phase I and the Additional Production Suite [***] produced in the Production Suite used in Phase I during the month immediately preceding CBSW's provision of the Additional Production Suite for Client's benefit. 3.3.5 Client acknowledges and agrees that its sole remedy with respect to CBSW's failure to provide the Custom Production Suite in its entirety is as set forth in Section 3.3.4, and in furtherance thereof Client hereby waives all other remedies at law or in equity regarding any claim arising under or relating to such failure. If CBSW is unable to provide the Custom Production Suite, the Construction Fee will be refunded to Client in full. 3.3.6 Upon final commissioning and validation of the Custom Production Suite CBSW will provide Client with written notice of completion of such commissioning and validation. Within [***] days after completion of such final commissioning and validation, CBSW will relocate the production of the Product from the Production Suite used to produce the Product during Phase I to the Custom Production Suite. Client will relinquish all rights to use the Phase I Production Suite upon completion of such relocation. If relocation will be delayed beyond such [***] day period because of acts or omissions of Client, Client will relinquish all rights to use the Phase I Production Suite at the end of such 30 day period