definiens: shall mean all s tandards, guidelines, rules, regulations and laws applicable to the Processing, storage, packaging, labeling, and shipping of Tissue by [COMPANY] . The Processing Standards shall include ( i ) applicable laws, regulations, and guidelines of the FDA ; ( ii ) applicable standards and guidelines promulgated by the AATB ; ( iii ) applicable laws and regulations of other U.S. federal, state and local government agencies with jurisdiction over the processing and distribution o f human musculoskeletal tissue ; ( iv ) applicable laws and regulations of non -U.S. jurisdictions where Tissue processed by [COMPANY] is procured or distri buted by or on behalf of MTF ; ( v ) MTF 's SOPs, as may be amended from time to time by MTF and as provided to [COMPANY] in advance of their effectiveness ; and ( v i ) [COMPANY] 's SOPs, as may be amended from time to time