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 will include those inputs specified in Section 9.1 below or other inputs the Catapult, using its reasonable judgment considers to be required for operation of Centre (and which are not specific to any Collaborator or ADAPTIMMUNE) and which may be varied from time to time to cater for the common, but not necessarily universal requirements of the collaborators of the Centre; Integral Inputs may be varied from time to time by Catapult, after prior discussion and consideration of concerns raised by ADAPTIMMUNE and Collaborators in the Operational Forum, in order to cater for the common, but not necessarily universal requirements of ADAPTIMMUNE and Other Collaborators in the Centre. Any changes made to the Integral Inputs made by Catapult will not impact the ability of the Centre to operate in accordance with EU-GMP requirements without the prior written consent of ADAPTIMMUNE, such consent not to be unreasonably withheld.
(ii) Activity Related Inputs which are Inputs specified in Section 9.3 below that are dependent on ADAPTIMMUNE’s Processes and activity and are specific to ADAPTIMMUNE’s use of the Module. It is a condition of occupation that the Integral Inputs and Activity Related Inputs will be procured through Catapult unless the parties agree otherwise. All such inputs shall be provided in accordance with the Quality Technical Agreement.
(iii) Additional Inputs 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 Clause 9.6 and any associated contributions from ADAPTIMMUNE in consideration of the Additional Inputs will be deemed as having been inserted at Schedule 3.
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 provided by Catapult are maintained in compliance with GMP Requirements and the Quality Technical Agreement;
9.1.2 management and governance of the Quality Management System GMP compliance process;
9.1.3 EU-GMP regulatory compliance of the Centre from start up, including handling of associated MHRA compliant compliance governance activity such as routine audit inspections, subject to the following provisions:
(a...
