Common use of Ongoing Trials Clause in Contracts

Ongoing Trials. Once TOBIRA commences any non-clinical or clinical trial of the Compound and/or the Product hereunder, then TOBIRA shall conduct such trial to its completion, unless TOBIRA’s decision to cease any such trial prior to its completion is due to one of the following causes: (i) if, in TOBIRA’s reasonable judgment, there are scientific or other technical problems, including any problems which relate to the safety, efficacy or toxicology of the Compound or Product; (ii) there are any significant, unexpected change in the regulatory requirements in a country concerning the development of the Compound or Product which comes into existence after the Effective Date, for example a new requirement for studies in specific patient sub-groups; or (iii) if, in TOBIRA’s reasonable judgment, there are significant, unexpected changes in the market that provide business justification for such cessation which comes into existence after the Effective Date, for example competitive products enter the market , provided, however, that in the case of subsections (ii) and (iii), TOBIRA shall complete the studies for the patient(s) already commenced (i.e., TOBIRA may decide not to conduct the newly required and/or additional studies, but TOBIRA shall conduct the portion of trials originally planned before such change of regulatory requirements or market change). In case of such cessation for any reason, TOBIRA shall be responsible for any and all winding-ups, including without limitation answering to the requests and/or questions from patients, including continuing to provide patients with the Product, if appropriate or required.