Regulatory and Procedures Sample Clauses

Regulatory and Procedures. 10.1.1 Sobi shall be the holder of and maintain (i) a Tissue Establishment License, if and where legally required in the Territory, (ii) a License for Pharmaceutical Wholesale Distribution; and (iii) any other Regulatory Approvals, including corresponding analysis, licenses or other permits, required to perform its obligations under this Agreement in the Territory and comply with all related local legislation. 10.1.2 The Parties recognize that the national requirements for Tissue Establishment Licenses (including import/export of Knee Cartilage and Biopsy-kits) may be different and when determining which Party between Sobi and TiGenix might be obliged to hold a Tissue Establishment License, this will be determined based on the Parties’ respective obligations under this Agreement. Notwithstanding the aforementioned, the decision to obtain any new Tissue Establishment License after the Commencement Date shall be the sole decision of each Party. In the event a Tissue Establishment License is necessary in a country in the Territory and the Party who, after the Commencement Date and based on the Parties’ respective obligations under this Agreement, should obtain the Tissue Establishment License decides not to obtain it, then Products will not be sold in such country. [***] Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to omitted portions. 10.1.3 The Parties recognize that certain countries in the Territory may require import or export licenses for the Product.. If a country requires a license for import or export in a country in the Territory, Parties shall determine which Party between Sobi and TiGenix should hold such license based on the Parties’ respective obligations under this Agreement. Notwithstanding the aforementioned, the decision to obtain any such license shall be the sole decision of each Party. In the event a license for import or export is necessary in a country in the Territory and the Party who, based on the Parties’ respective obligations under this Agreement, should obtain the license decides not to obtain such license (and no Third Party will hold it), then Products will not be sold in such country. 10.1.4 Sobi acknowledges that the Product is currently only registered in the EU. TiGenix shall decide in its sole discretion if, when and where it wishes to register the Product outside the EU. 10.1.5 Outside of the EU, but within the Territory, Sobi is allo...