Regulatory and Procedures. 11.1.1 TiGenix shall be Marketing Authorization holder of the Product in the European Union, and shall maintain ownership over the Marketing Authorization in the European Union. In accordance with clause 10.1.4, TiGenix shall decide in its sole discretion if, when and where it wishes to register the Product in the remainder of the Territory. As long as TiGenix decides not to register the Product in any country outside the European Union, it may be that there is no Marketing Authorization holder of the Product in the remainder of the Territory.
Appears in 4 contracts
Samples: Distribution Agreement (TiGenix NV), Distribution Agreement (TiGenix NV), Distribution Agreement (TiGenix NV)