Additional Development Related to Regulatory Filings in the European Territory Sample Clauses

Additional Development Related to Regulatory Filings in the European Territory. In connection with seeking Marketing Approval of a Product in the European Territory, if additional Clinical Trials (excluding any Phase IV Trials or post-Marketing Approval studies (including registries)) are imposed by the EMA or required by applicable Law, TaiMed and Theratechnologies shall consult with each other to develop a business case to carry out such Clinical Trials. TaiMed shall be responsible to estimate the out-of-pocket costs to be incurred outside of its organization for the conduct of such Clinical Trials and Theratechnologies shall be responsible to estimate the potential market in the European Territory. Both Parties shall unanimously agree on the extent of the additional Clinical Trials to be conducted and on the budget associated therewith prior to undertaking such Clinical Trials. If the Parties do not agree on the conduct of such Clinical Trials, or the budget associated therewith, Theratechnologies shall no longer be required to use its Commercially Reasonable Efforts to obtain Marketing Approval of a Product and shall be released from any of its obligations under this Agreement with respect to the European Territory. If the Parties agree to conduct such Clinical Trials, TaiMed shall act as the Sponsor of the Clinical Trial and shall conduct such Clinical Trials (excluding any Phase IV Trials or post-Marketing Approval studies (including the keeping of registries)). TaiMed shall keep Theratechnologies reasonably informed through the JDC of the Development of the Product, and provide additional information related to the Product as may be reasonably requested by Theratechnologies at Taimed’s sole cost and expense.