from CBC's representations and warranties herein, CBC and MediWound shall work together in order to enable the CBC facility to accomplish all required standards, related to the manufacturing, packaging and delivering of Bromelain SP in accordance with the Specifications, GACP (Good Agricultural and Collection Practice) and cGMP (Current Good Manufacturing Practice) standards, ISO 22000 and all other applicable laws and regulations. For such purpose, and without derogating from other terms herein, CBC shall permit MediWound, and/or a consultant on MediWound's behalf, to access and inspect the CBC facility and advise MediWound and/or CBC on such actions to be taken for accomplishing such compliance. Such mutual regulatory preparations shall begin no later than the finalization of MediWound's current phase III clinical trial. CBC warrants and represents that all Bromelain SP shall be manufactured and supplied in compliance with the Specifications, quality control methods and test methods, all applicable SOP's and all applicable laws, and in accordance with GACP, cGMP, including the relevant guidelines, policies, codes, requirements, regulations, approvals and/or standards from time to time promulgated or issued by any relevant governmental and/or regulatory authority which relate to the manufacture of the Bromelain SP to be used for the production of a pharmaceutical agent as the Product. CBC warrants further that CBC has, and will for the duration of this Agreement retain, all applicable regulatory approvals required for the carrying out of its obligations hereunder, including without limitation the manufacturing, packaging and supply of the Bromelain SP. 5.2 All manufacturing, packaging and labeling activities done at CBC will be performed according to the pre-approved batch records. If CBC wishes to make changes to the Specifications, the production and/or packaging batch records, the SOPs related to the Bromelain SP, or the design of the manufacturing process or any other change during production which