Common use of Manufacturing and Logistics Clause in Contracts

Manufacturing and Logistics. 11.2.1 TiGenix shall be responsible for manufacturing and release of the Product in accordance with the ChondroCelect Specifications and cGMP. TiGenix shall ensure that prior to pick-up of the Implantation-kit, the Product has been released by the qualified person in accordance with the Marketing Authorization. Manufacturing will only commence after the Knee Cartilage Biopsy has been released by the Tissue Establishment according to the currently valid SOP and all other requirements have been fulfilled, including but not limited to the verification of the Informed Consent Form of the Patient and verification of the Laboratory Test results. 11.2.2 TiGenix shall provide local customer support for Hospitals in Belgium and the Netherlands. 11.2.3 TiGenix shall manage logistical co-ordination with the courier (for the transportation of Biopsy-kits, Biopsies, and Products in Implantation-kit), the Manufacturing Facility and Sobi’s central customer support. . 11.2.4 TiGenix shall perform initial ChondroCelect Training on the Product to Sobi key personnel, as specified in Schedule 8 and thereafter as mutually agreed between the Parties. 11.2.5 TiGenix shall provide Sobi with general training material, documentation, forms and updates thereof as needed for the Biopsy and Implantation in English with the understanding that Sobi shall remain responsible for all national documentation needed in the Territory as specified in clause 10.4.1 11.2.6 All transportation of Biopsy-kits, Knee Cartilage and/or the Product shall be carried out in accordance with applicable laws including cGDP, the User Manual, and the then valid SOPs. [***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions. 11.2.7 In the event the logistical partners used by TiGenix raise material concerns in terms of quality of service or because their prices are unreasonably high, the Parties shall discuss and in good faith try to find a solution. 11.2.8 TiGenix shall inform Sobi of any proposed amendments to existing courier agreements or the introduction of any proposed new couriers in advance and shall give Sobi the opportunity to review and provide comments on the proposed amendments or new couriers and TiGenix shall take into account any reasonable comments. Changes to a courier agreement which are required by applicable laws and regulations are in TiGenix sole discretion to include. Changes to a courier agreement which are not required by applicable law or regulations require Sobi’s prior approval, such approval not to be unreasonably withheld.