Global Safety Database; Licensed Territory Sample Clauses

Global Safety Database; Licensed Territory. As between the Parties, Disc shall establish, hold and maintain ([***]) a global safety database for Licensed Antibodies and Licensed Products with respect to information on adverse events concerning Licensed Antibodies and Licensed Products, as and to the extent required by Applicable Law. Disc shall collect all information necessary to comply with its pharmacovigilance responsibilities in the Licensed Territory, including, as applicable, any adverse drug experiences taking place within the Licensed Territory (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States) from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies, and commercial experiences with a Licensed Product, and such safety database shall be maintained by Disc for at least [***].