All Applicable Laws

All Applicable Laws. All federal, state and/or local laws rules and regulations of the United States, and foreign countries having authority over the conduct of clinical studies, and which govern the conduct of clinical studies or other activities of Osiris in providing Services (as defined below) under this Agreement. For studies conducted under an Investigational New Drug application ("IND"), applicable laws and regulations include, but are not limited to, 21 CFR §'s 312, 50, 56, and 11 (and 65/65/EEC,... 75/318/EEC, 91/507/EEC for studies conducted in a European Union member state) and all conditions of approval imposed by the reviewing Institutional Review Board ("IRB"), established pursuant to 21 CFR § 56 / Ethics Committee and FDA and other authorities View More