Common use of CATAPULT INPUTS, FACILITIES AND SUPPORT Clause in Contracts

CATAPULT INPUTS, FACILITIES AND SUPPORT. The operation of the Centre is dependent on a range of critical inputs split between: (i) Integral Inputs are inputs Catapult, using its reasonable judgment considers as fundamental to the operation of the Centre and that all collaborators will draw on in equal measure. Integral Inputs may be varied from time to time by Catapult, after prior discussion and consideration of concerns raised by COLLABORATOR and Other Collaborators in the Operational Forum, in order to cater for the common, but not necessarily universal requirements of the COLLABORATOR and Other Collaborators in the Centre. (ii) Activity Inputs are inputs that are dependent on COLLABORATOR’s manufacturing processes and activity. It is a condition of occupation that the Integral Inputs, Establishment Inputs and Activity Related Inputs will be procured through Catapult. (iii) Additional Inputs are inputs COLLABORATOR requires Catapult to contribute to the Project. These will be arranged through the completion of an Additional Input Agreement in the form set out at Schedule 16 (“Additional Input Agreement”). Once signed by both Parties, the Additional Input Agreement will amend this agreement and an Additional Input will be deemed appended to the list of Additional Inputs at Clause 9.4 and any associated contributions from COLLABORATOR in consideration of the Additional Inputs will be deemed as having been inserted at Schedule 3.

CATAPULT INPUTS, FACILITIES AND SUPPORT. The operation of the Centre is dependent on a range of critical inputs split between: (i) Integral Inputs are inputs Catapult, using its reasonable judgment considers as fundamental to the operation of the Centre and that all collaborators All Collaborators will draw on on, but not necessarily in equal measure. Integral Inputs may be varied from time to time by Catapult, after prior discussion and consideration of concerns raised by COLLABORATOR and Other Collaborators in the Operational Forum, in order to cater for the common, but not necessarily universal requirements of the COLLABORATOR and Other Collaborators in the Centre.. Where COLLABORATOR’s utilisation of Integral Inputs is materially in excess of COLLABORATOR’s proportional contribution, COLLABORATOR may be required to enter into an additional input agreement (ii) Activity Related Inputs are inputs that are dependent on COLLABORATOR’s manufacturing processes and activity. It is a condition of occupation the collaboration that the Integral Inputs, Establishment Inputs and Activity Related Inputs will be procured through Catapult. (iii) Additional Inputs are inputs COLLABORATOR requires Catapult to contribute to the Project. These will be arranged through the completion of an Additional Input Agreement in the form set out at Schedule 16 (“Additional Input Agreement”). Once signed by both Parties, the Additional Input Agreement will amend this agreement and an Additional Input will be deemed appended to the list of Additional Inputs at Clause 9.4 and any associated contributions from COLLABORATOR in consideration of the Additional Inputs will be deemed as having been inserted at Schedule 3.

CATAPULT INPUTS, FACILITIES AND SUPPORT. The operation of the Centre is dependent on a range of critical inputs split between: (ia) Integral Inputs which are inputs Inputs Catapult, using its reasonable judgment considers as fundamental to the operation of the Centre and that all collaborators will draw on in In equal measure. Such Integral Inputs are listed in Clause 9.1, but may be varied from time to time by Catapult, after prior discussion and consideration of concerns raised by COLLABORATOR and Other Collaborators in the Operational Forumgood faith, in order to cater for the common, but not necessarily universal universal, requirements of the COLLABORATOR and Other Collaborators collaborators in the Centre., while at all times maintaining robust compliance with health and safety and GMP guidelines; inputs included at Clause 9.1 may not be removed or varied without prior notification of COLLABORATOR, and (iib) Activity Related Inputs which are inputs that are dependent on COLLABORATOR’s manufacturing processes and activity, and are listed at Clause 9.2 but may be varied from time to time by Catapult, in good faith, to meet COLLABORATOR’S requirements and with prior notification of COLLABORATOR, but may not include Items from Clause 9.1 without prior agreement of COLLABORATOR. (c) Establishment inputs which are activities to be performed by Catapult, in conjunction with COLLABORATOR, to support the On-boarding Project. It is a condition of occupation that the Integral Inputs, Establishment Inputs Inputs, and Activity Related Inputs will be procured through Catapult. (iiid) Additional Inputs are inputs COLLABORATOR requires Catapult to contribute to the Project, that are not Integral Inputs, Establishment Inputs or Activity Related Inputs. These will be arranged through the completion and execution of an Additional Input Agreement Agreement, on reasonable terms to be agreed, in the form set out at Schedule 16 (“Additional Input Agreement”). Once signed by both Parties, the Additional Input Agreement will amend this agreement and an Additional Input will be deemed appended to the list of Additional Inputs at Clause 9.4 and any associated contributions from COLLABORATOR in consideration of the Additional Inputs will be deemed as having been included in the Additional Input Agreement, and inserted at Schedule 3. For the avoidance of doubt, such an Input which does not impact on the Centre, the Centre’s GMP compliance or other Collaborators may, alternatively where COLLABORATOR determines, be sourced by COLLABORATOR from a Third Party provider, Which will be reasonably facilitated by Catapult, where requested by COLLABORATOR. 9.1 Catapult shall provide the following Integral Inputs: 9.1.1 the Quality Management System and supporting quality assurance function assuring all GMP inputs contributed by Catapult are maintained in compliance with GMP Requirements; 9.1.2 management and governance of the Quality Management System GMP compliance process; 9.1.3 regulatory compliance of the Centre from start up, including handling of associated MHRA compliant activities such as routine audits; for the avoidance of doubt all audit of COLLABORATOR Process will be COLLABORATOR’S responsibility; 9.1.4 Catapult and Centre insurance as described in Clause 19; 9.1.5 safety systems and equipment such as emergency light testing, fire extinguishers, health and safety equipment outside the Manufacturing Space, and associated safety audits; 9.1.6 a managed reception during business hours, and the provision of a mechanism for COLLABORATOR to access the Module at any time (24 hours a day, 7 days a week, 365 days per year), except in situations of Centre shutdown / an emergency; 9.1.7 all utilities necessary for the operations of the Centre (but not the Manufacturing Space) as set out in Schedule 14;

CATAPULT INPUTS, FACILITIES AND SUPPORT. The operation of the Centre is dependent on a range of critical inputs split between: (i) Integral Inputs are inputs Catapult, using its reasonable judgment considers as fundamental to the operation of the Centre and that all collaborators All Collaborators will draw on on, but not necessarily in equal measure. Integral Inputs may be varied from time to time by Catapult, after prior discussion and consideration of concerns raised by COLLABORATOR and Other Collaborators in the Operational Forum, in order to cater for the common, but not necessarily universal requirements of the COLLABORATOR and Other Collaborators in the Centre. Where COLLABORATOR’s utilisation of Integral Inputs is materially in excess of COLLABORATOR’s proportional contribution, COLLABORATOR shall be required to increase its proportional contributions to reflect its increased utilisation of Integral Inputs. (ii) Activity Related Inputs are inputs that are dependent on COLLABORATOR’s manufacturing processes COLLABORATOR Manufacturing Process and activity. It is a condition of occupation the Collaboration that the Integral Inputs, Establishment Inputs and Activity Related Inputs will be procured through Catapult. (iii) Additional Inputs are inputs COLLABORATOR requires Catapult to contribute to the Project. These will be arranged arranged, as needed, through the completion of an Additional Input Agreement in the form set out at Schedule 16 Error! Reference source not found. (“Additional Input Agreement”). Once signed by both Parties, the Additional Input Agreement will serve to add further Inputs to this Agreement or amend the Additional Inputs in this agreement Agreement as applicable, and an Additional Input will be deemed appended to the list of Additional Inputs at Clause 9.4 and any associated contributions from COLLABORATOR in consideration of the Additional Inputs will be deemed as having been inserted at Schedule 3Error! Reference source not found.. (iv) Establishment Inputs which are activities to be performed by Catapult, in conjunction with COLLABORATOR, to support the introduction of any new Collaborator Product and Process. 9.1 Catapult will provide the following Integral Inputs: 9.1.1 the Quality Management System and supporting quality assurance function assuring all GMP inputs contributed by Catapult are maintained in compliance with GMP Requirements; 9.1.2 management and governance of the Quality Management System GMP compliance process; 9.1.3 GMP regulatory compliance of the Centre, including handling of associated MHRA compliance governance activity such as routine audits inspections, subject to the following provisions: (a) From the Occupation Date, and subject to Clause 9.1.3(b) below, if any activity required to ensure GMP regulatory compliance of the Centre, including the handling of associated MHRA compliance governance activity such as inspections (“MHRA Compliance Activity”) impacts any COLLABORATOR Product and/or any COLLABORATOR Manufacturing Process, then the interactions with the MHRA related to such activity will be led by COLLABORATOR with assistance being provided by Catapult. COLLABORATOR will be entitled to nominate representatives to coordinate and accompany all inspections involved in such MHRA Compliance Activity on COLLABORATOR's behalf; (b) If any MHRA Compliance Activity required as a result of COLLABORATOR activity in the Module or Centre impacts on any Catapult personnel, Other Collaborator personnel, Catapult activity within the Centre, Other Collaborator(s), or any part of the Centre other than the Module, then the interactions with the MHRA related to such activity will be led by Catapult and assisted by COLLABORATOR. During inspections, Catapult will be entitled to nominate representatives to coordinate and accompany all MHRA activity in this paragraph on Catapult's behalf; and (c) To the extent any MHRA Compliance Activity impacts on COLLABORATOR’s use of the Module or performance of the COLLABORATOR Manufacturing Process, Catapult will notify COLLABORATOR of such MHRA Compliance Activity and keep COLLABORATOR informed of the progress and communication relevant to such MHRA Compliance Activity. 9.1.4 insurance as described in Clause 19.1; 9.1.5 safety systems and equipment such as emergency light testing, fire extinguishers, health and safety equipment outside the Manufacturing Space, and associated safety audits; 9.1.6 a managed reception within Office Hours, and the provision of a mechanism for COLLABORATOR to access the Module at any time; 9.1.7 all utilities necessary for the operations of the Centre (but not the Manufacturing Space) as set out in Schedule Error! Reference source not found.; 9.1.8 support for IT Infrastructure; for the avoidance of doubt, this does not include applications support for COLLABORATOR; 9.1.9 hosting, maintenance and administration of all IT systems (BMS, EMS, eQMS, LIMS and WMS) plus all required access rights for IT systems required primarily for Centre functions and required even when no Collaborators are in occupation (BMS, EMS); 9.1.10 receipt of incoming patient material and starting material into the Centre within Office Hours; 9.1.11 a system for booking in and managing COLLABORATOR owned inventory for raw materials, consumables, product contact materials and excipients within the warehouse; 9.1.12 short term final product and drug substance storage subject to terms to be agreed; 9.1.13 out of hours call out system for all facilities alarms (bar the Manufacturing Space alarms); 9.1.14 cleaning and disinfection of all areas outside of the Manufacturing Space and outside of any Quality Control laboratory space occupied by any Collaborator; 9.1.15 (save with respect to the Manufacturing Space which is provided for in Clause 9.2.1 and for any Quality Control laboratory space occupied by any Collaborator)) perform environmental monitoring in the form of viable and non-viable particulate monitoring required to demonstrate maintenance of the appropriate environmental classifications; 9.1.16 access to a controlled rate freezer and allocated short term storage capacity at the following temperatures: controlled room temperature, 2-8°C, -20°C, -80°C and gas phase of liquid nitrogen; 9.1.17 Toilet provision and services in relation to toilets available for COLLABORATOR use; 9.1.18 Security input as required for general security of Centre; 9.1.19 program and relationship management; 9.1.20 kitchen areas and vending machines for snacks, hot and cold drinks within the Centre; 9.1.21 a dedicated secure, unfurnished Manufacturing Office and a Non-Manufacturing Office per Module; and 9.1.22 any other Inputs which Catapult, using its reasonable judgment, considers as fundamental to the operation of the Centre and that the COLLABORATOR and all Other Collaborators will draw on in, albeit not necessarily in equal measure. 9.1.23 Shift system of warehouse personnel to be available to receive incoming patient material and starting material into the Centre outside of Office Hours, with notice and subject to terms of an Additional Input Agreement if such input is to be utilised by COLLABORATOR; 9.2 Catapult will provide the following Activity Related Inputs: 9.2.1 perform environmental monitoring in the form of viable monitoring and non-viable particulate monitoring required to demonstrate maintenance of the appropriate environmental classifications, including undertaking remote non-viable sampling in the Manufacturing Space, provided that the COLLABORATOR is responsible for performing viable sampling in the Manufacturing Space which will then be processed by Catapult; 9.2.2 measured electrical power to the Manufacturing Space; 9.2.3 upon request of COLLABORATOR, Manufacturing Space decontamination; 9.2.4 a measured supply of pharmaceutical grade oxygen, nitrogen, carbon dioxide, and air; 9.2.5 routine maintenance for the air handling system, including ULPA and HEPA filter changes 9.2.6 gowning for Catapult staff providing services to the Collaborators, (COLLABORATOR gowning is ordered by COLLABORATOR from Catapult warehouse stock); 9.2.7 Leased telephone line with a data package from the supplier if required; 9.2.8 transfer of decontaminated clinical, biological and hazardous chemical liquid waste from the liquid waste staging area and arrange its removal from the Centre by appropriately licensed contractors; 9.2.9 transfer of decontaminated clinical and biological solid waste from the solid waste staging area and arrange its removal from the Centre by appropriately licensed contractors; 9.2.10 packing, and dispatch as described in Schedule Error! Reference source not found.; 9.2.11 warehouse movements over and above a fair usage level (to be determined by Catapult from time to time) 9.2.12 access rights to IT systems required for COLLABORATOR activity within the module: eQMS, LIMS, WMS; 9.2.13 provision of Quality Assurance inputs to support for COLLABORATOR’s operation within the Module; in terms of handling non-process related deviations, Quality Events and planned changes, cleanroom environmental excursions, governance of Catapult generated GMP data provided to COLLABORATOR, providing GMP documentation to support Qualified Person certification of drug product; 9.2.14 engineering and maintenance support for COLLABORATOR’s operation within the Module. 9.3 Catapult provided the following Establishment Inputs as per the Establishment Input Statement dated 22 January 2018. Catapult will provide further Establishment Inputs if requested by COLLABORATOR due to COLLABORATOR’s requirement to introduce a new COLLABORATOR Product or Process: 9.3.1 Catapult will decontaminate the Manufacturing Space, replace all HEPA filters and re-qualify the Manufacturing Space at termination of the Agreement at COLLABORATOR’s cost; and 9.3.2 Catapult will select and authorise All Collaborators and ensure their processes and procedures meet the minimum standards required by Catapult, such standard in each case sufficient to meet the requirement of this Agreement including GMP.