,,ii #aai? ,,congress #a/ ,session ,s4 #ahia ,,9 ,,! ,,s5ate ,,( ,,! ,,unit$ ,,/ates ,may #bb1 #bjbe,mr4 ,cotton introduc$ ! foll[+ bill2 :i* 0 read twice & ref]r$ to ! ,committee on ,f9ance ,a ,,bill ,to am5d ! ,int]nal ,rev5ue ,code ( #aihf to e/abli% ! g5]ic drugs & biosimil>s production cr$it1 & = o!r purposes4 #a4 ,%ort title ,?is ,act may be cit$ z ! ,produc+ ,inc5tives = ,long-t]m production ( ,lifesav+ ,supply ( m$ic9e ,act or ! ,,pills ,act4 #b4 ,g5]ic drugs & biosimil>s production cr$it 7a7 ,9 g5]al ,subp>t ,d ( "p ,,iv ( sub*apt] ,a ( *apt] #a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new section3 #de;,,bb4 ,g5]ic drugs & biosimil>s production cr$it 7a7 ,9 g5]al 7#a7 ,all[ance ( cr$it ,= purposes ( section #ch1 ! g5]ic drugs & biosimil>s production cr$it = any taxable ye> is an am\nt equal to ! cr$it am\nt det]m9$ "u subsection 7b7 ) respect to ea* eligible compon5t :i* is-- 7,a7 produc$ by ! taxpay] 9 ! ,unit$ ,/ates1 & 7,b7 sold by su* taxpay] to an unrelat$ p]son 7z det]m9$ by ! ,secret>y7 dur+ ! taxable ye>4 7#b7 ,production & sale mu/ be 9 trade or bus9ess ,rules simil> to ! rules ( section #de,x7a77#b7 %all apply4 7#c7 ,disall[ance ( cr$it ,! cr$it "u ?is subsection %all n be all[$ to any taxpay] :i*1 at any "t dur+ ! taxable ye>1 0 a =eign entity ( conc]n 7z def9$ 9 section #iija7h7 ( ! ,william ,m4 7,mac7 ,?ornb]ry ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjba 7#ae ,u4,s4,c4 #dfea774 7b7 ,cr$it am\nt ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,subject to p>agraph 7#d71 ! am\nt det]m9$ "u ?is subsection ) respect to any eligible compon5t is an am\nt equal to ! base cr$it p]c5tage ( ! value add$ to su* compon5t by ! taxpay]4 7#b7 ,value add$ ,! value add$ to a compon5t by a taxpay] is an am\nt equal to-- 7,a7 ! gross receipts receiv$ by ! taxpay] f ! sale ( ! eligible compon5t1 m9us 7,b7 ! co/ ( eligible compon5ts pur*as$ f an unrelat$ p]son 9 connection ) ! production ( ! compon5t by ! taxpay]4 7#c7 ,base cr$it p]c5tage 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraphs 7,b7 & 7,c71 ! base cr$it p]c5tage is #cj p]c5t4 7,b7 ,increas$ base cr$it p]c5tage = c]ta9 eligible compon5ts ,! base cr$it p]c5tage is #ce p]c5t 9 ! case ( ! f9al production (-- 7i7 a drug sub/ance1 7ii7 a drug product1 or 7iii7 a biological product4 7,c7 ,dome/ic cont5t bonus cr$it 7i7 ,9 g5]al ,9 ! case ( an eligible compon5t :i* conta9s dome/ic cont5t1 ! base cr$it p]c5tage det]m9$ "u ?is p>agraph 7det]m9$ )\t reg>d to ?is subp>agraph7 %all be increas$ by an am\nt equal to-- 7,i7 ! dome/ic cont5t p]c5tage1 multipli$ by 7,,ii7 #j4bj4 7ii7 ,dome/ic cont5t p]c5tage ,= purposes ( ?is subp>agraph1 ! t]m dome/ic cont5t p]c5tage means ! p]c5tage ( ! total co/ ( ! eligible compon5ts tak5 into acc\nt = purposes ( p>agraph 7#b7 :i* is attributable to mat]ials & compon5ts t 7 produc$ 9 ! ,unit$ ,/ates4 7iii7 ,docum5tation rules 7,i7 ,record keep+ ,no dome/ic cont5t bonus cr$it %all be det]m9$ "u ?is subp>agraph unless ! taxpay] provides docum5tation support+ ! dome/ic cont5t p]c5tage 79 su* =m & mann] z ! ,secret>y %all prescribe74 7,,ii7 ,c]tification by unrelat$ p>ty ,9 ! case ( mat]ials or compon5ts provid$ to ! taxpay] by an unrelat$ p>ty1 ! ,secret>y %all accept c]tification 79 su* =m & mann] z ! ,secret>y %all prescribe7 by su* unrelat$ p>ty t ! mat]ials or compon5ts 7 produc$ 9 ! ,unit$ ,/ates4 7#d7 ,phase out 7,a7 ,9 g5]al ,9 ! case ( any eligible compon5t sold aft] ,decemb] #ca1 #bjcj1 ! am\nt det]m9$ "u ?is subsection ) respect to su* compon5t %all be equal to ! product (-- 7i7 ! am\nt det]m9$ "u p>agraph 7#a7 ) respect to su* compon5t 7det]m9$ )\t reg>d to ?is p>agraph & aft] ! application ( p>agraphs 7#b7 & 7#c771 & 7ii7 ! phase out p]c5tage4 7,b7 ,phase out p]c5tage ,= purposes ( subp>agraph 7,a71 ! phase out p]c5tage is-- 7i7 9 ! case ( an eligible compon5t sold dur+ cal5d> ye> #bjca1 #ge p]c5t1 7ii7 9 ! case ( an eligible compon5t sold dur+ cal5d> ye> #bjcb1 #ej p]c5t1 7iii7 9 ! case ( an eligible compon5t sold dur+ cal5d> ye> #bjcc1 #be p]c5t1 & 7iv7 9 ! case ( an eligible compon5t sold aft] ,decemb] #ca1 #bjcc1 #j p]c5t4 7c7 ,def9itions ,= purposes ( ?is section-- 7#a7 ,eligible compon5t 7,a7 ,9 g5]al ,except z provid$ 9 subp>agraphs 7,b7 & 7,c71 ! t]m eligible compon5t means-- 7i7 an approv$ g5]ic drug1 7ii7 a lic5s$ biosimil>1 & 7iii7 any drug sub/ance1 int]m$iate raw mat]ial1 />t+ mat]ial1 reag5t1 compon5t1 9-process mat]ial1 inactive +r$i5t1 conta9] closure sy/em1 packag+1 quality te/+1 or o!r mat]ial or s]vice us$1 or sold ) int5tion = use1 9 ! production ( an approv$ g5]ic drug or a lic5s$ biosimil>4 7,b7 ,exclusion ( c]ta9 compon5ts ,! t]m eligible compon5t %all n include a compon5t any portion ( ! production ( :i* occurr$ at a facility :i* is ! subject ( a w>n+ lett]-- 7i7 :i* 0 issu$ by ! ,food & ,drug ,adm9i/ration on or aft] ,septemb] #a1 #bjji1 & 7ii7 ) respect to :i* ! ,food & ,drug ,adm9i/ration has n issu$ a close-out lett]4 7,c7 ,application ) o!r cr$its ,! t]m eligible compon5t %all n include any prop]ty :i* is produc$ at a facility if ! basis ( any prop]ty :i* is "p ( su* facility is tak5 into acc\nt = purposes ( ! cr$it all[$ "u section #dh;,f aft] ! date ( ! enactm5t ( ?is section4 7#b7 ,approv$ g5]ic drug ,! t]m approv$ g5]ic drug means-- 7,a7 a drug = :i* an approval ( an application fil$ "u section #eje7;j7 ( ! ,f$]al ,food1 ,drug1 & ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 is 9 effect1 or 7,b7 an au?oriz$ g5]ic drug 7z def9$ 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation774 7#c7 ,lic5s$ biosimil> 7,a7 ,9 g5]al ,! t]m lic5s$ biosimil> means a biological product = :i* a biologics lic5se has be5 issu$ "u section #cea7k7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7k774 7,b7 ,biological product ,! t]m biological product has ! mean+ giv5 su* t]m 9 section #cea7;i77#a7 ( ! ,public ,heal? ,s]vice ,act 7#db ,u4,s4,c4 #bfb7;i77#a774 7#d7 ,o!r t]ms ,! t]ms drug sub/ance & drug product h ! respective mean+s giv5 su* t]ms 9 section #cad4c ( title #ba1 ,code ( ,f$]al ,regulations 7or any successor regulation74 7#e7 ,produc$ 9 ! ,unit$ ,/ates ,! t]m produc$ 9 ! ,unit$ ,/ates means t all ! production ( ! mat]ial or compon5t takes place 9 ! ,unit$ ,/ates1 reg>dless ( ! orig9 ( ! subcompon5ts ( su* mat]ial or compon5t4 7#f7 ,production ,! t]m production means all /eps 9 ! manufacture1 propagation1 & prep>ation ( an eligible compon5t1 includ+ syn!sis1 mix+1 granulat+1 mill+1 mold+1 lyophiliz+1 tablet+1 encapsulat+1 coat+1 /]iliz+1 te/+1 fill+1 label+1 packag+1 & /orage prior to release by ! manufactur]4 7d7 ,special rules ,rules simil> to ! rules ( p>agraphs 7#a71 7#c71 & 7#d7 ( section #de,x7d7 %all apply4 7e7 ,regulatory au?ority ,! ,secret>y %all prescribe su* regulations & o!r guidance z are appropriate or necess>y to c>ry out ! purposes ( ?is section4 4 7b7 ,elective paym5t 7#a7 ,9 g5]al ,section #fdag7;b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ac7 ,! g5]ic drugs & biosimil>s production cr$it det]m9$ "u section #de;,,bb4 4 7#b7 ,election ) respect to o!r entities ,p>agraph 7#a7 ( section #fdag7;d7 is am5d$-- 7,a7 by r$esignat+ subp>agraph 7,e7 z subp>agraph 7,f71 7,b7 by /rik+ or 7,d7 ea* place x appe>s 9 subp>agraph 7,f71 z s r$esignat$1 & ins]t+ 7,d71 or 7,e71 & 7,c7 by ins]t+ aft] subp>agraph 7,d7 ! foll[+ new subp>agraph3 7,e7 ,election ) respect to g5]ic drugs & biosimil>s production cr$it 7i7 ,9 g5]al ,if a taxpay] o!r ?an an entity describ$ 9 subp>agraph 7,a7 makes an election "u ?is subp>agraph ) respect to any taxable ye> 9 :i* su* taxpay] has1 aft] ,decemb] #ca1 #bjbd1 produc$ eligible compon5ts 7z def9$ 9 section #de;,,bb7c77#a771 su* taxpay] %all be treat$ z an applicable entity = purposes ( ?is section = su* taxable ye>1 b only ) respect to ! cr$it describ$ 9 subsection 7b77#ac74 7ii7 ,o!r rules ,! rules ( clauses 7ii7 & 7iii7 ( subp>agraph 7,d7 %all apply = purposes ( ?is subp>agraph4 4 7c7 ,transf] ( cr$its ,section #fdah7;f77#a7;,a7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new clause3 7xii7 ,! g5]ic drugs & biosimil>s production cr$it det]m9$ "u section #de;,,bb4 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #ch7;b7 ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7,a7 by /rik+ plus at ! end ( p>agraph 7#dj71 7,b7 by /rik+ ! p]iod at ! end ( p>agraph 7#da7 & ins]t+ 1 plus1 & 7,c7 by add+ at ! end ! foll[+ new p>agraph3 7#db7 ! g5]ic drugs & biosimil>s production cr$it det]m9$ "u section #de;,,bb7a74 4 7#b7 ,! table ( sections = subp>t ,d ( "p ,,iv ( sub*apt] ,a ( *apt] #a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by add+ at ! end ! foll[+ new item3 ,sec4 #de;,,bb4 ,g5]ic drugs & biosimil>s production cr$it4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to g5]ic drugs & biologics produc$ aft] ! date ( enactm5t ( ?is ,act4 #c4 ,g5]ic drugs & biosimil>s inve/m5t cr$it 7a7 ,9 g5]al ,subp>t ,e ( "p ,,iv ( sub*apt] ,a ( *apt] #a ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$ by ins]t+ aft] section #dh;,e ! foll[+ new section3 #dh;,f4 ,g5]ic drugs & biosimil>s inve/m5t cr$it 7a7 ,e/abli%m5t ( cr$it ,= purposes ( section #df1 ! g5]ic drugs & biosimil>s inve/m5t cr$it = any taxable ye> is an am\nt equal to #be p]c5t ( ! qualifi$ inve/m5t = su* taxable ye> ) respect to any qualifi$ facility ( an eligible taxpay]4 7b7 ,qualifi$ inve/m5t ,= purposes ( ?is section-- 7#a7 ,9 g5]al ,! qualifi$ inve/m5t = any taxable ye> is ! basis ( any qualifi$ prop]ty plac$ 9 s]vice by ! taxpay] dur+ su* taxable ye> :i* is "p ( a qualifi$ facility4 7#b7 ,qualifi$ prop]ty 7,a7 ,9 g5]al ,! t]m qualifi$ prop]ty means prop]ty-- 7i7 :i* is tangible prop]ty1 7ii7 ) respect to :i* depreciation 7or amortization 9 lieu ( depreciation7 is all[able1 7iii7 :i* is-- 7,i7 con/ruct$1 recon/ruct$1 or erect$ by ! taxpay]1 or 7,,ii7 acquir$ by ! taxpay] if ! orig9al use ( su* prop]ty comm5ces ) ! taxpay]1 & 7iv7 :i* is us$ z an integral "p ( ! qualifi$ facility to produce eligible compon5ts4 7,b7 ,build+s & /ructural compon5ts 7i7 ,9 g5]al ,! t]m qualifi$ prop]ty includes any build+ or its /ructural compon5ts :i* o!rwise satisfies ! requirem5ts ( subp>agraph 7,a74 7ii7 ,exception ,clause 7i7 %all n apply ) respect to a build+ or portion ( a build+ us$ = (fices1 adm9i/rative s]vices1 or o!r functions unrelat$ to ! production ( eligible compon5ts4 7#c7 ,qualifi$ facility ,! t]m qualifi$ facility means a facility-- 7,a7 :i* is own$ 79 :ole or 9 "p7 by ! taxpay]1 7,b7 :i* is locat$ 9 ! ,unit$ ,/ates or any t]ritory ( ! ,unit$ ,/ates1 & 7,c7 ! prim>y purpose ( :i* is ! production ( eligible compon5ts4 7#d7 ,coord9ation ) rehabilitation cr$it ,! qualifi$ inve/m5t ) respect to any qualifi$ facility = any taxable ye> %all n include t portion ( ! basis ( any prop]ty :i* is attributable to qualifi$ rehabilitation exp5ditures 7z def9$ 9 section #dg7;c77#b774 7#e7 ,c]ta9 progress exp5diture rules made applicable ,rules simil> to ! rules ( subsections 7c77#d7 & 7d7 ( section #df 7z 9 effect on ! day be=e ! date ( ! enactm5t ( ! ,rev5ue ,reconciliation ,act ( #aiij7 %all apply4 7c7 ,def9itions ,= purposes ( ?is section-- 7#a7 ,eligible taxpay] ,! t]m eligible taxpay] means any taxpay] :i* is n a =eign entity ( conc]n 7z def9$ 9 section #iija7h7 ( ! ,william ,m4 7,mac7 ,?ornb]ry ,national ,def5se ,au?orization ,act = ,fiscal ,ye> #bjba 7#ae ,u4,s4,c4 #dfea74 7#b7 ,eligible compon5t ,! t]m eligible compon5t has ! mean+ giv5 su* t]m 9 section #de;,,bb7c77#a74 7#c7 ,production ,! t]m production has ! mean+ giv5 su* t]m 9 section #de;,,bb7c77#f74 7d7 ,t]m9ation ( cr$it ,! cr$it all[$ "u ?is section %all n apply to prop]ty ! con/ruction ( :i* beg9s aft] ,decemb] #ca1 #bjbh4 7e7 ,regulatory au?ority ,! ,secret>y %all prescribe su* regulations & o!r guidance z are appropriate or necess>y to c>ry out ! purposes ( ?is section4 4 7b7 ,elective paym5t 7#a7 ,9 g5]al ,section #fdag7;b7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by section #b7;b7 ( ?is ,act1 is fur!r am5d$ by add+ at ! end ! foll[+ new p>agraph3 7#ad7 ,! g5]ic drugs & biosimil>s inve/m5t cr$it det]m9$ "u section #dh;,f4 4 7#b7 ,election ) respect to o!r entities ,p>agraph 7#a7 ( section #fdag7;d7 ( su* ,code1 z am5d$ by ?is ,act1 is fur!r am5d$-- 7,a7 by r$esignat+ subp>agraph 7,f7 z subp>agraph 7,g71 7,b7 by /rik+ or 7,e7 ea* place x appe>s 9 subp>agraph 7,g71 z s r$esignat$1 & ins]t+ 7,e71 or 7,f71 & 7,c7 by ins]t+ aft] subp>agraph 7,e7 ! foll[+ new subp>agraph3 7,f7 ,election ) respect to g5]ic drugs & biosimil>s inve/m5t cr$it ,if a taxpay] o!r ?an an entity describ$ 9 subp>agraph 7,a7 makes an election "u ?is subp>agraph ) respect to any taxable ye> 9 :i* su* taxpay] has plac$ 9 s]vice a qualifi$ facility 7z def9$ 9 section #dh;,f7b77#c771 su* taxpay] %all be treat$ z an applicable entity = purposes ( ?is section = su* taxable ye>1 b only ) respect to ! cr$it describ$ 9 subsection 7b77#ad74 4 7c7 ,transf] ( cr$its ,section #fdah7;f77#a7;,a7 ( ! ,int]nal ,rev5ue ,code ( #aihf1 z am5d$ by ?is ,act1 is fur!r am5d$ by add+ at ! end ! foll[+ new clause3 7xiii7 ,! g5]ic drugs & biosimil>s inve/m5t cr$it det]m9$ "u section #dh;,f4 4 7d7 ,con=m+ am5dm5ts 7#a7 ,section #df ( ! ,int]nal ,rev5ue ,code ( #aihf is am5d$-- 7,a7 by /rik+ & at ! end ( p>agraph 7#f71 7,b7 by /rik+ ! p]iod at ! end ( p>agraph 7#g7 & ins]t+ 1 &1 & 7,c7 by add+ at ! end ! foll[+ new p>agraph3 7#h7 ! g5]ic drugs & biosimil>s inve/m5t cr$it4 4 7#b7 ,section #di7;a77#a77;,c7 ( su* ,code is am5d$-- 7,a7 by /rik+ & at ! end ( clause 7vii71 7,b7 by /rik+ ! p]iod at ! end ( clause 7viii7 & ins]t+ 1 &1 & 7,c7 by add+ at ! end ! foll[+ new clause3 7ix7 ! basis ( any qualifi$ prop]ty :i* is "p ( a qualifi$ facility "u section #dh;,f4 4 7#c7 ,! table ( sections = subp>t ,e ( "p ,,iv ( sub*apt] ,a ( *apt] #a is am5d$ by ins]t+ aft] ! item relat+ to section #dh;,e ! foll[+ new item3 #dh;,f4 ,g5]ic drugs & biosimil>s inve/m5t cr$it4 4 7e7 ,effective date ,! am5dm5ts made by ?is section %all apply to prop]ty plac$ 9 s]vice aft] ,decemb] #ca1 #bjbf4