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.
Appears in 4 contracts
Samples: Distribution Agreement (TiGenix NV), Distribution Agreement (TiGenix NV), Distribution Agreement (TiGenix NV)
