Facility Modification and Equipment Clause Samples
Facility Modification and Equipment. Except as otherwise specifically provided herein to the contrary, and upon mutual agreement of the Parties, Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and if it is necessary or Client deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date, the Core Team shall determine equitable allocation of costs including, as applicable, procurement, validation, installation, maintenance, commissioning, and decommissioning/validation (which determination shall be escalated to the JSC if in dispute). Thereafter, if any additional equipment is necessary at the request of Client, such costs shall be dealt with by the Change provisions of this MSA. SBL shall modify the Facility and engineer, procure, install, commission, test, qualify, troubleshoot and validate necessary equipment and instruments in order to accommodate Manufacture of the Product at the Facility, as further described in the Project Plan and applicable QAG. Except as provided in this Section 5.2 or any applicable PSA, the Facility, Warehouse and all the equipment shall be maintained, tested, validated, calibrated and qualified for their intended uses by SBL at SBL’s expense. For the avoidance of doubt, it shall be the responsibility of SBL to effect such changes at the Facility including, but not limited to changes in equipment, as are required by changes in laws, rules or regulations related to the manufacture, handling, storage, packaging and disposal of biologics generally, compliance therewith being necessary in order for SBL to hold itself out as a qualified manufacturer of biologics for human use. It shall be the responsibility of SBL to obtain, maintain and pay all costs associated with establishment licenses required for the Facility, the Warehouse and any other facilities used by SBL in the performance of its obligations under this MSA and any applicable PSA.
Facility Modification and Equipment. Except as otherwise specifically provided herein to the contrary, and upon mutual agreement of the Parties, Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and if it is necessary or Client deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date, the Core Team shall determine equitable allocation of costs including, as applicable, procurement, validation, installation, maintenance, commissioning, and decommissioning/validation (which determination shall be escalated to the JSC if in dispute). Thereafter, if any additional equipment is necessary, such costs and ownership of such equipment shall be dealt with pursuant to Sections 6.1 and/or 17.9, as applicable. SBL shall modify the Facility and engineer, procure, install, commission, test, qualify, troubleshoot and validate necessary equipment and instruments in order to accommodate Manufacture of the Product at the Facility, as further described in the Project Plan and applicable QAG. Except as provided in this MSA or any applicable PSA, the Facility, Warehouse and all the equipment shall be maintained, tested, validated, calibrated and qualified for their intended use by SBL at SBL’s expenses.
Facility Modification and Equipment. Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and if Client reasonably deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date, SBL shall procure such equipment at Client’s expense in accordance with Section 8.2.4 and be responsible during the Term for validation, installation, maintenance, commissioning, and decommissioning at SBL’s expense, unless otherwise agreed in writing by the Parties. Thereafter, if any additional equipment is necessary, such costs shall be dealt with by Section 5 of this MSA. Notwithstanding anything to the contrary in this MSA, the ownership of any and all such equipment shall remain at all times with SBL unless otherwise agreed in writing by both Parties.
Facility Modification and Equipment. Client and SBL will cooperate to reach a mutual agreement on what equipment in the Facility is necessary to perform the Services, and if Client reasonably deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date and subject to the mutual agreement in writing between SBL and Client, SBL shall procure such equipment at Client’s expense in accordance with Section 8.2.4 and be responsible during the Term for validation, installation, maintenance including repairs and cleaning, commissioning, and decommissioning, unless otherwise agreed in writing by the Parties. Thereafter, if any additional equipment is necessary, such costs shall be dealt with by Section 5 of this MSA. Notwithstanding anything to the contrary in this MSA, the ownership of any and all such equipment shall remain at all times with SBL unless otherwise agreed in writing by both Parties. SBL shall use any Client-dedicated equipment procured pursuant to this Section 4.4 (“Equipment”) primarily for the benefit of Client.
Facility Modification and Equipment. Except as otherwise specifically provided herein to the contrary, and upon mutual written agreement of the Parties, Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and, if the Parties deem it necessary, to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date. The Core Team shall determine [*]. Thereafter, if any additional equipment is necessary, such costs shall be dealt with by the Change provisions of this MSA. Except as provided in this MSA or any applicable PSA, the Facility, Warehouse and all the equipment shall be maintained, tested, validated, calibrated and qualified for their intended use by SBL [*].
Facility Modification and Equipment. Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and if Client reasonably deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date, SBL shall procure such equipment at Client’s expense in accordance with Section 8.2.4 and SBL shall be responsible during the Term for validation, installation, maintenance, commissioning, and decommissioning at SBL’s expense, unless otherwise agreed in writing by the Parties. Thereafter, if any additional equipment is necessary, such costs shall be dealt with by Section 5 of this MSA. SBL shall use Commercially Reasonable Efforts to negotiate pricing with the vendors of any equipment deemed necessary to procure and to procure such equipment [***]. Notwithstanding anything to the contrary in this MSA, the ownership of any and all such equipment shall remain at all times with SBL unless otherwise agreed in writing by both Parties, and SBL shall in good faith and in accordance with its obligations under this MSA or applicable PSA, make such equipment available to perform Services for Client. If additional equipment is purchased pursuant to this Section 4.4, the Parties shall agree in writing as to whether such equipment will be used solely to perform Services for Client or may be used to perform Services for SBL clients in addition to Client.
Facility Modification and Equipment. Client and SBL will agree on what equipment in the Facility is necessary to perform the Services, and if Client reasonably deems it necessary to procure additional equipment beyond that which is in the Facility as of the applicable PSA Effective Date, SBL shall procure such equipment at Client’s expense in accordance with Section 8.2.4 and SBL shall be responsible during the Term for validation, calibration, installation, maintenance, repairs, commissioning, and decommissioning at SBL’s expense, unless otherwise agreed in writing by the Parties, all in accordance with the QAG. Thereafter, if any additional equipment is necessary, such costs shall be dealt with by Section 5 of this MSA. Notwithstanding anything to the contrary in this MSA, the ownership of any and all such equipment shall remain at all times with SBL, and SBL shall in good faith and in accordance with its obligations under this MSA or applicable PSA, make available such equipment for Client’s use during the Manufacturing schedule reserved by Forecast or binding Purchase Order during the term of the applicable PSA. Any modifications to the Facility, equipment, Raw Materials (including the applicable suppliers thereof), or Manufacturing Process shall be subject to the change control procedures set forth in Section 5 of this MSA, QAG, and any applicable PSA.