Adolescent Study Protocol Sample Clauses

Adolescent Study Protocol. Aevi has been using and will continue to use commercially reasonable efforts to conduct the clinical study with the protocol titled “Phase IB Escalating Dose, Open-label, Signal Finding Study to Evaluate the Safety, Tolerability, and Short Term Efficacy of the anti-LIGHT monoclonal KHK252067 in Adolescents (12-18 years of age) with Crohn’s disease resistant to anti-TNF alpha monoclonal antibodies, with and without loss of function mutations in decoy receptor 3 (DcR3) (anti-LIGHT in anti-TNFalpha resistant Crohn’s disease (TRaCk LIGHT)” (the “Adolescent Study”), the protocol for which is attached hereto in Exhibit A (the “Adolescent Study Protocol”). The Adolescent Study is intended to preliminarily assess (but without sufficient statistical power) whether a certain genetic mutation may identify a pediatric orphan population that may be treatable with a Licensed Product. As further set forth in Section 3.1, Aevi will bear all costs and expenses, including but not limited to FTE costs and out-of-pocket costs, incurred by or on behalf of Aevi or its Affiliates and their contractors relating to the conduct of the Adolescent Study and the analysis of the results of the Adolescent Study.