definiens: means ( i ) any iUlJ. all pcrmils, lkenscs, filing~ ~nU eeriiticalions requi«XI by the FDA or other Regulatory Authorilie~, ancl eomplinncc with ~-GMPs, applicllble 10 any Pro.:ess.ing Activity or Procnsing Fncility . and ( ii ) any laws ( including Ihe En\',rolUno : nla l Prolettlon Agency ( EPA ) . the Drug EoforcemcJII AJministrahon ( DF.A ), and the Ot : cupatiollll i Safety and Heahh Administration ( OSHA », Ihat apply 10 Wly Prooossing Acth'ity or Processing I,'acility, I .22 .~ . mcallS the lIel Q ( selling, ll'it$ing or otherwlIse tronsferring . providing . or 11JmislllllK for aoy oonsideralion . CotT ~ nd ingly, ~Sell~ means 10 m .. ke or cause 10 be made a S .. le and ~So[d " mc.1ns to have made or cauo;ed to be mude a Sale