definiens: means any supra - national, fed eral, foreign, national, state, county, local, municipal or other governmental, regulatory or admi nistrative authority, agency, commission or other instrumentality, any court, tribunal or arbitral bo dy with competent jurisdiction, or any national sec urities exchange or automated quotation service, including any gover nmental regulatory authority or agency responsible for the grant of approval, clearance, qualification, licens ing or permitting of any aspect of the Research, De velopment, registration, manufacture, making, formulating, hav ing made, use or Commercialization of any of the Co mbined Products . means Combined Net Sales less ( i ) th e Cost of Goods Sold, ( ii ) legal defense, litigatio n, and any litigation settlement expenses that are exc lusively related to the Product, solely to the exte nt in respect of actions or events that occurred prior to the Closin g Date, and ( iii ) expenses in respect of settlement of the existing litigation with Teva solely to the extent in excess of $ 300,000 in the aggregate