definiens: shall mean all standards, guidelines, rules, regulations and laws applicable to the donation, recovery, and suitability of Tissue . The -5-\\\DC . 6050810014.200)252 vl2 Recovery Standards shall include applicable standards and requirements relating to Donor referral, informed consent, tissue recovery, pre - processing storage, packaging and shipping of pre - processed Tissue and all records, activities and standards related to obtaining, testing, documenting and evaluating serological test results ; obtaining, documenting and evaluating medical history and lifestyle data ; and related organizational, management and quality assurance activities as may be contained in applicable ( i ) laws, regulations, and guidelines of the FDA ; ( ii ) standards and guidelines promulgated by the AA TB ; ( iii ) laws and regulations of other U.S. federal, state and local government agencies with jurisdiction over the procurement and distribution of human musculoskeletal tissue ; ( iv ) laws and regulations of non - U.S. jurisdictions where such Tissue Processed by [COMPANY] is procured pursuant to this Agreement or distributed by or on behalf of MTF or [COMPANY] ; ( v ) MTF 's SOPs, as may be amended from time to time by MTF ; and ( vi ) [COMPANY] 's standards for recovered Tissue, to the extent applicable to MTF Tissue, as specified in [COMPANY] 's SOPs, as may be amended from time to time by [COMPANY] and as provided to MTF in advance of their effectiveness