definiens: has the meaning as set out in Section 16.1 ; 1.36 means the directors, officers, employees, agents, Third Party Contractors orprofessional advisers of the relevant Party who are required, on a strict need to know basis, in the courseof their duties, to receive and consider the Confidential Information for the purpose of enabling therelevant Party to perform its obligations under this Agreement provided that such persons are underobligations of confidence no less onerous than those contained in Section 15 which are imposed on theReceiving Party ; 1.37 means the price for the Services as defined in Schedule 2 ; 1.38 means the method of manufacturing the Product, including quality control and qualityassurance ; 1.39 means ChondroCelect ®, a cell - based medicinal product based on characterized viableautologous cartilage - forming cells expanded ex vivo expressing specific marker proteins as activeingredient, in its current and possible future form or expression ; 1.40 means the commercial manufacturing and GMP production of the Product ; 1.41 means the person ( in accordance with Article 48 of Directive 2001/83 / EC and withArticle 13(2 ) of Directive 2001/20 / EC ), qualified to perform batch certification and Batch Conformity ; 1.42 means the agreement between the Parties that further defines the rolesand responsibilities of the Parties with respect to the Services, and the processes and communicationsflows to be followed, as set out in Schedule 4 ; 1.43 has the meaning as set out in Section 15.1 ; 1.44 has the meaning as set out in Section 11.1 ; 1.45 means the schedule ( or schedules as appropriate ) to this Agreement which specify theServices, payment terms and other relevant details referred to under this Agreement ; 1.46 means any or all parts of the services to be rendered by the Supplier, including theProduction, under this Agreement as more fully described in Schedule 2 ; 1.47 means the criteria to be met by Supplier in respect of the Product as set out inSchedule 5 ; 1.48 ( or single point of contact ) means the designated representative from each Party who will beresponsible for management of the overall performance of this Agreement . Each Party will designate oneperson as a SPOC to the other Party in writing . Each Party shall be entitled to change its respectivedesignated SPOC at any time and shall promptly give written ( or e - mail ) notice of the change to the otherParty including the new contact details of the new representative(s ) in any event no less than seven(7 ) Business Days after the change has been implemented ; [ * * * ] Certain information has been omitted and filed separately with the Commission . Confidential treatment has beenrequested with respect to omitted portions