Common use of Pre-Clinical Studies Clause in Contracts

Pre-Clinical Studies. GRELAN agrees at its sole expense to sponsor and conduct (or have sponsored and conducted) all necessary additional pre-clinical and non-clinical studies and tests required by the Japanese Ministry of Health and Welfare (the "MHW") or other local regulatory agency in the Territory in connection with commencing and conducting human clinical trials with respect to the Venture Products in the Territory and with respect to the manufacture (or importation into the Territory), sale and distribution of Venture Products in the Territory. BIONUMERIK will provide free of charge to KI PHARMA and GRELAN all pre-clinical data, clinical research protocols, and clinical trials data and information previously or hereafter developed by BIONUMERIK that were used and/or are necessary to support United States Food and Drug Administration ("FDA") regulatory submissions to support regulatory applications for the Venture Products BN in the Territory. GRELAN will provide free of charge to KI PHARMA and BIONUMERIK all pre-clinical data, clinical research protocols, and clinical trials data and information previously or hereafter developed by GRELAN that are necessary to support regulatory submissions to support regulatory applications for the Venture Products GR in the Territory.