definiens: means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or othergovernmental entity, including the FDA, with authority over the development, manufacture or commercialization of any Product(s ) in any jurisdiction in anycountry where COMPANY may commercialize Product.1.31 means the requirements and standards for eachProduct set forth on Schedule B, which may include ( i ) raw material specifications(including chemical, micro, and Labeling and Packaging specifications ) ; ( ii)sampling requirements ( i.e., lab, chemical, and micro ) ; ( iii ) compounding module, including compounding process and major equipment ; ( iv ) intermediatespecifications ; ( v ) Packaging modules ( including Packaging procedures, torqueand fill weights ) ; and ( vi ) finished Product specifications release criteria includingDPT ’s Acceptable Quality Limits ( ) . Specifications shall be established oramended from time to time upon the written agreement of both [COMPANY] andCOMPANY via a Change Control Request in accordance with Article 6 below