definiens: means a manual, • table of contents of which Is anached hereto as Appendix I, containing cenain apeclfications, procedures, methods and raonnel contacts relating to he manufacturing and suppl of the arrier S Emis here to LIII that will be . ' compiled and agreed upon between the Panlas prior .the commencement of manufacture 0iii1~~~~ b Emil here . Section . of the ! Res ", iblillies Document may be from to time through tha Issuance of a revised aectlon Incorporating the modification and stating the affective date of the modification . Each such revised section shall be signed on behalf of the Panles by 8 duly euthorized representetive, The duly authorized representative shall be of a managemant level no lower than the management level of the duly authorized re resentative who Ii ned thet lectlon of the original Manufacturin Res onsibilities Documen means milestones as specified In the Appendices to the Option Agreement, end for compounds for which milestones are not specified In the Option Agreement, shall be agreed upon by the Panies after good faith negotiations ; means any New Drug Application In relation to a Product(s ) filed by [COMPANY] or its approved designee with the FDA or a similar application filed in another jurisdiction ; means with respect to the Product(s ) the gross amount invoiced by [COMPANY], its Affiliates andlor any sub · licensee of [COMPANY] or Its Affilietes to unrelated third panies for the Product(s ) less the following seven Items : ( a ) trade quentity end cesh discounts actually allowed ; ( b ) commission, discounts, refunds, rebates, charge backs, retroactive price adjustments, and eny other allowances which effectively reduce the net lelling price ; ( c ) actual product returns and allowances ; ( d ) that ponion of the sales value assocleted with non pharmaceutlcel drug delivery devices ( not to include [COMPANY] 's Carriers ) ; ( e ) eny tax imposed on the production, sale, delivery or use of the Product(s ) ; ( f ) allowence for distribution ( transponation ) expenses ( limit of ~ of gross 10 · Optlon · · Option Agreement eny other similar, reasonable end customary deductions which are properly recorded es a reduction of .ales under GAAP, consistently applied