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0 | LLY | 2015 | Eli Lilly and Company (the “company” or “registrant” or "Lilly") was incorporated in 1901 in Indiana to succeed to the drug manufacturing business founded in Indianapolis, Indiana, in 1876 by Colonel Eli Lilly. We discover, develop, manufacture, and market products in two business segments—human pharmaceutical products and animal health products. | [-0.008280634880065918, -0.007574935909360647, -0.01596563495695591, -0.007736793719232082, -0.007121734786778688, 0.01565486751496792, -0.017195751890540123, 0.01394565124064684, -0.0024019668344408274, 0.010663178749382496, -0.008753259666264057, 0.010902728885412216, 0.021701868623495102, 0.0048524909652769566, 0.002083107363432646, 0.022828396409749985, 0.013155786320567131, -0.034158430993556976, 0.0006178914336487651, 0.007672050502151251, -0.023540571331977844, 0.004124131985008717, 0.007866280153393745, 0.004554673098027706, -0.029004883021116257, -0.011414198204874992, 0.021145077422261238, -0.0200056005269289, 0.022931985557079315, -0.005438415799289942, -0.03027384728193283, -0.00967908464372158, -0.022931985557079315, -0.001828990993089974, -0.00959491916000843, -0.006467829924076796, -0.005856008268892765, 0.0066879563964903355, 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1 | LLY | 2015 | The mission of our human pharmaceutical business is to make medicines that help people live longer, healthier, more active lives. Our vision is to make a significant contribution to humanity by improving global health in the 21st century. 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2 | LLY | 2015 | Our animal health business, operating through our Elanco division, develops, manufactures, and markets products for both food animals and companion animals. Elanco food animal products help the food industry produce an abundant supply of safe, nutritious and affordable food. 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3 | LLY | 2015 | We manufacture and distribute our products through facilities in the United States (U.S.), Puerto Rico, and 14 other countries. 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6 | LLY | 2015 | •Glyxambi®, a combination tablet of linagliptin and empagliflozin (Jardiance) for the treatment of type 2 diabetes (approved in the U.S. in 2015) | [-0.014703057706356049, -0.0235917828977108, 0.016671184450387955, -0.01203386764973402, -0.011692983098328114, 0.014986056834459305, -0.018870854750275612, -0.011397121474146843, -0.009943538345396519, -0.012008140794932842, 0.023205876350402832, -0.002564673777669668, -0.009544767439365387, -0.008039729669690132, -0.013468155637383461, 0.011416416615247726, 0.020015710964798927, 0.01222038920968771, 0.014625877141952515, -0.010683192871510983, 0.0007653823122382164, 0.015243328176438808, 0.012824976816773415, -0.01767454296350479, 0.0010170257883146405, 0.005476663820445538, 0.0021466079633682966, -0.01709568127989769, -0.013738290406763554, 0.022189654409885406, 0.004425067454576492, 0.010432353243231773, -0.01973271369934082, 0.00023154422524385154, -0.011744437739253044, -0.013558200560510159, -0.003240011166781187, 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7 | LLY | 2015 | •Synjardy®, a combination tablet of empagliflozin and metformin hydrochloride for the treatment of type 2 diabetes (approved in the U.S. and Europe in 2015)[DATA_TABLE_REMOVED] | [-0.00901094265282154, -0.020253658294677734, -0.00013313636009115726, -0.024665601551532745, -0.017402665689587593, 0.031064210459589958, -0.019660240039229393, -0.01787998154759407, -0.01607392355799675, -0.0012916545383632183, 0.031399622559547424, 0.0026445859111845493, -0.014242063276469707, -0.007372589781880379, -0.014435569755733013, 0.004424843937158585, 0.023646468296647072, -0.012197346426546574, 0.013300332240760326, -0.010352586396038532, -0.0061147985979914665, 0.01128141675144434, 0.009404405951499939, -0.022549932822585106, -0.005947093479335308, 0.008985142223536968, -0.009191548451781273, -0.00468607759103179, -0.02853572741150856, 0.009120596572756767, 0.0016528662526980042, -0.0006788845639675856, -0.01929902657866478, -0.0005111790960654616, -0.02089867927134037, 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8 | LLY | 2015 | ◦approved in 2014 in the U.S. and the European Union (EU), and in Japan in 2015, both as a single agent and in combination with another agent as a second-line treatment of advanced or metastatic gastric cancer | [-0.00635975506156683, -0.005094227846711874, 0.01088867150247097, -0.027366219088435173, -0.004805148113518953, 0.017447570338845253, -0.01703643426299095, -0.006706650834530592, -0.0134389977902174, 0.00047376961447298527, 0.010875822976231575, -0.0008162488811649382, -0.00036315646138973534, -0.007715217769145966, -0.023871565237641335, 0.00664883479475975, 0.023974349722266197, -0.00979659240692854, 0.0019432584522292018, 0.012706661596894264, 0.0027542877942323685, -0.00439080037176609, -0.008743057027459145, -0.005039623938500881, 0.01417133305221796, 0.023421885445713997, 0.013901525177061558, -0.03119491972029209, 0.005511787720024586, 0.012764478102326393, -0.0019336225232109427, 0.00570771936327219, -0.017794465646147728, 0.0010856551816686988, 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9 | LLY | 2015 | ◦approved in 2014 in the U.S., and in the EU in 2016, in combination with another agent as a second-line treatment of metastatic NSCLC | [-0.011375345289707184, -0.013853772543370724, 0.0014679915038868785, -0.04023949056863785, -0.00874439999461174, 0.011972709558904171, -0.025928162038326263, 0.0008356748148798943, -0.027072051540017128, 0.019840126857161522, 0.0005890236352570355, 0.008274134248495102, 0.007905547507107258, 0.003301392076537013, -0.008788884617388248, -0.004975919146090746, 0.011445249430835247, -0.012201488018035889, -0.0013067348627373576, -0.0037239957600831985, 0.0027389798779040575, -0.012271392159163952, 0.0037462380714714527, -0.029410669580101967, 0.009920063428580761, -0.0006315223290584981, -0.0004226036253385246, -0.03886682167649269, 0.001361546223051846, 0.017094792798161507, 0.008496556431055069, 0.02009432576596737, -0.010295005515217781, -0.00635494152083993, -0.013879192061722279, -0.010905079543590546, -0.017819255590438843, 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10 | LLY | 2015 | ◦approved in 2015 in the U.S., and in the EU in 2016, as a second-line treatment of metastatic colorectal cancer | [-0.008754134178161621, -0.008076843805611134, -0.0073679047636687756, -0.023952020332217216, -0.015849856659770012, 0.005855078808963299, -0.024952130392193794, -0.012893833220005035, -0.008830091916024685, 0.032915037125349045, 0.010798664763569832, -0.004557466600090265, 0.010115044191479683, -0.009671957232058048, -0.032763123512268066, -0.005196778103709221, 0.017444970086216927, -0.009178231470286846, -0.00029216051916591823, 0.008108492940664291, 0.0019210989121347666, 0.006399442907422781, -0.004766350612044334, -0.004737866576761007, 0.005076511763036251, 0.009076954796910286, 0.012317820452153683, -0.038257401436567307, -0.0017897551879286766, 0.004839143715798855, -0.0005843210383318365, -0.006494390312582254, -0.01471048966050148, -0.020989665761590004, -0.025521814823150635, -0.0070767332799732685, -0.002357856137678027, 0.007007105275988579, 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11 | LLY | 2015 | •Portrazza™, approved in 2015 in the U.S. for use in combination with other agents as a first-line treatment of metastatic squamous NSCLC, and approved in 2016 in the EU for use in combination with other agents as a first-line treatment for epidermal growth factor receptor expressing squamous NSCLC | [-0.022488387301564217, -0.006631616968661547, 0.018490158021450043, -0.02916981652379036, 0.008328540250658989, 0.00542617030441761, -0.018197927623987198, -0.012326771393418312, -0.03421741724014282, 0.008029669523239136, 0.004393404815346003, 0.0012959381565451622, -0.02571619488298893, 0.007923404686152935, -0.007319020573049784, 0.004290460143238306, 0.01720169000327587, -0.012419753707945347, -0.00887979194521904, -0.017520487308502197, 0.009052473120391369, 0.00315308989956975, -0.00362298171967268, -0.04797876998782158, -0.01619216986000538, 0.011536423116922379, 0.01429267879575491, -0.024919206276535988, -0.0020323232747614384, 0.006442332174628973, 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12 | LLY | 2015 | On January 1, 2015, we completed our acquisition of Novartis Animal Health (Novartis AH) in an all-cash transaction for $5.28 billion. Novartis AH operates in approximately 40 countries. The combined organization has added several hundred products to our animal health product portfolio, expanded our global commercial presence, and augmented our animal health manufacturing and research and development. In particular, it has provided Elanco with a greater commercial presence in the companion animal and swine markets, expanded Elanco’s presence in equine and vaccines areas, and created an entry into the aquaculture market. Acquired Novartis AH products include: | [-0.007876128889620304, -0.010703456588089466, 0.010820719413459301, -0.020742425695061684, -0.018071448430418968, 0.015700140967965126, -0.008736053481698036, -0.010755573399364948, -0.02250136248767376, 0.006120448932051659, 0.007153009995818138, 0.011113875545561314, -0.0017524223076179624, -0.013420036993920803, 0.01241027656942606, 0.026735840365290642, 0.015739228576421738, -0.03207779675722122, -0.015270178206264973, -0.009016180410981178, -0.039113543927669525, 0.016520977020263672, -0.018957430496811867, -0.000778085261117667, -0.0040390403009951115, 0.011876081116497517, 0.0015325552085414529, -0.01149172056466341, -0.004130244255065918, -0.012338616885244846, -0.01405846606940031, 0.007100893184542656, -0.01765451394021511, 0.01138748787343502, -0.013576386496424675, 0.00949825905263424, -0.007628574501723051, -0.002174241468310356, 0.02902897261083126, 0.006012958474457264, 0.01996067725121975, -0.003166086506098509, 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14 | LLY | 2015 | We sell most of our products worldwide. 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15 | LLY | 2015 | In the U.S., we distribute human pharmaceutical products principally through independent wholesale distributors, with some sales directly to pharmacies. In 2015, 2014, and 2013, three wholesale distributors in the U.S.—AmerisourceBergen Corporation, McKesson Corporation, and Cardinal Health, Inc.—each accounted for between 8 percent and 19 percent of our consolidated total revenue. 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16 | LLY | 2015 | We promote our major human pharmaceutical products in the U.S. through sales representatives who call upon physicians and other health care professionals. We advertise in medical journals, distribute literature and samples of certain products to physicians, and exhibit at medical meetings. In addition, we advertise certain products directly to consumers in the U.S., and we maintain websites with information about our major products. We supplement our employee sales force with contract sales organizations as appropriate to leverage our own resources and the strengths of our partners in various markets. | [-0.007708063814789057, 0.004710113164037466, 0.0024683126248419285, -0.01770789362490177, 0.007048514671623707, 0.025715753436088562, 0.003357704496011138, 0.03091219998896122, 0.009573454968631268, 0.0038040659856051207, 0.004726768471300602, 0.014936455525457859, -0.009773318655788898, 0.0081810737028718, -0.019026992842555046, 0.0031078753527253866, 0.028753675520420074, -0.02920669876039028, -0.016268877312541008, -0.021545270457863808, -0.005249744281172752, 0.012224975973367691, -0.002368380781263113, 0.00785463023930788, -0.026608476415276527, 0.019959688186645508, 0.015682611614465714, -0.021332083269953728, 0.010233004577457905, -0.006332337390631437, -0.005343013908714056, 0.0015048045897856355, -0.013963786885142326, -0.008360950276255608, 0.015083021484315395, 0.004453621804714203, 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17 | LLY | 2015 | We maintain special business groups to service wholesalers, pharmacy benefit managers, managed care organizations, government and long-term care institutions, hospitals, and certain retail pharmacies. 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18 | LLY | 2015 | Outside the U.S, we promote our human pharmaceutical products primarily through sales representatives. While the products marketed vary from country to country, endocrinology products constitute the largest single group in total revenue. Distribution patterns vary from country to country. 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19 | LLY | 2015 | •We and Boehringer Ingelheim have a diabetes alliance under which we jointly develop and commercialize Trajenta, Jentadueto, Jardiance, Glyxambi, Synjardy, and Basaglar in major markets. | [-0.01687890850007534, -0.032205432653427124, 0.021786026656627655, -0.014037253335118294, -0.0021197304595261812, 0.02836393378674984, -0.015879066661000252, -0.0009348849998787045, 0.00023701020109001547, -0.00791322160512209, 0.011050883680582047, 0.004446664825081825, -0.009584009647369385, -0.010603585280478, 0.004637424368411303, 0.010958792641758919, 0.020720405504107475, -0.004877517931163311, 0.019339045509696007, -0.02654843218624592, 0.00010637708328431472, 0.004644002299755812, 0.017523543909192085, 0.007143606897443533, -0.005985895171761513, 0.00942614022642374, 0.0034303783904761076, -0.018155023455619812, -0.013760981149971485, 0.010445715859532356, -2.4204640794778243e-05, 0.029258528724312782, -0.02615375630557537, 0.021851805970072746, 0.0036342935636639595, 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20 | LLY | 2015 | •We co-promote Cymbalta in Japan with Shionogi & Co. 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21 | LLY | 2015 | •Through September 30, 2015, Erbitux was marketed in the U.S. and Canada by Bristol-Myers Squibb (BMS). Effective October 1, 2015, BMS transferred to us all commercialization rights for Erbitux in those two countries. 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22 | LLY | 2015 | •Effient is co-promoted with us by Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) in the U.S., Brazil, Mexico, and certain other countries. Through the end of 2015, we also co-promoted Effient with Daiichi Sankyo in major European markets. Effective January 2016, Daiichi Sankyo is exclusively promoting Effient in major European markets; however, the economic results for these countries will continue to be shared in the same proportion as under the previous arrangement. We retain sole marketing rights in Canada, Australia, Russia, and certain other countries. Daiichi Sankyo retains sole marketing rights in Japan and certain other countries. | [-0.027845775708556175, 0.01218753308057785, 0.002586346585303545, -0.027552101761102676, -0.01057899184525013, 0.031716953963041306, 0.0011905537685379386, 0.0015017497353255749, -0.017620529979467392, -0.01616550050675869, 0.005826788954436779, 0.01744699478149414, 0.00018187856767326593, -0.007275143172591925, -0.019729653373360634, 0.008463193662464619, 0.028005963191390038, -0.03398626297712326, -0.0014258278533816338, -0.006914723198860884, -0.033398911356925964, 0.012334370985627174, -0.007448678370565176, 0.0032421108335256577, -0.005453019868582487, 0.0013023506617173553, 0.014950752258300781, -0.02374766767024994, -0.023787714540958405, -0.0033572448883205652, -0.002616381738334894, 0.01910225674510002, -0.008690125308930874, -0.004612040240317583, 0.008569984696805477, -0.024962417781352997, -0.019262442365288734, -0.006090429145842791, 0.036709435284137726, -0.032010629773139954, 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24 | LLY | 2015 | Our Elanco animal health business unit employs field salespeople throughout the U.S. and has an extensive sales force outside the U.S. Elanco sells its products primarily to wholesale distributors. Elanco promotes its products primarily to producers and veterinarians for food animal products and to veterinarians for companion animal products. 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25 | LLY | 2015 | Our human pharmaceutical products compete globally with products of many other companies in highly competitive markets. 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26 | LLY | 2015 | Important competitive factors for both human pharmaceutical and animal health products include effectiveness, safety, and ease of use; price and demonstrated cost-effectiveness; marketing effectiveness; and research and development of new products, processes, and uses. Most new products that we introduce must compete with other branded or generic products already on the market or products that are later developed by competitors. 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27 | LLY | 2015 | We believe our long-term competitive success depends upon discovering and developing (either alone or in collaboration with others) or acquiring innovative, cost-effective human pharmaceutical and animal health products that provide improved outcomes and deliver value to payers, and continuously improving the productivity of our operations in a highly competitive environment. There can be no assurance that our research and development efforts will result in commercially successful products, and it is possible that our products will become uncompetitive from time to time as a result of products developed by our competitors. | [-0.016178537160158157, -0.0068228342570364475, 0.0023256647400557995, -0.015104388818144798, -0.011305084452033043, 0.03140227496623993, -0.003912023268640041, 0.018432924523949623, -0.025143038481473923, 0.015130911022424698, -0.004843615461140871, 0.02356496825814247, 0.004323117434978485, -0.014680033549666405, -0.02632327564060688, 0.015780704095959663, 0.036282360553741455, -0.02267647534608841, -0.009561249986290932, -0.022888652980327606, -0.013413598760962486, 0.002569337375462055, 0.0005279573961161077, -0.018379880115389824, -0.01762399636209011, 0.014587205834686756, 0.00820198841392994, -0.021721675992012024, 0.0024765096604824066, -0.004110939800739288, 0.00516519695520401, 0.016178537160158157, -0.0005035072681494057, 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28 | LLY | 2015 | One of the biggest competitive challenges we face is from generic pharmaceuticals. In the U.S. and the EU, the regulatory approval process for human pharmaceuticals (other than biological products (biologics)) exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allowing generic manufacturers to rely on the safety and efficacy of the innovator product. Therefore, generic manufacturers generally invest far less than we do in research and development and can price their products much lower than our branded products. Accordingly, when a branded non-biologic human pharmaceutical loses its market exclusivity, it normally faces intense price competition from generic forms of the product. Public and private payers typically encourage the use of generics as alternatives to brand-name drugs in their healthcare programs. Laws in the U.S. generally allow, and in many cases require, pharmacists to substitute generic drugs that have been rated under government procedures to be essentially equivalent to a brand-name drug. Where substitution is mandatory, it must be made unless the prescribing physician expressly forbids it. 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29 | LLY | 2015 | with generic or counterfeit versions of our products. 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30 | LLY | 2015 | Several of our current products, including Cyramza, Erbitux, Trulicity, and Portrazza, and many of the new molecular entities (NMEs) in our research pipeline are biologics. Competition for Lilly’s biologics may be affected by the approval of follow-on biologics, also known as biosimilars. A biosimilar is a subsequent version of an an approved innovator biologic that, due to its physical/structural similarity to the original product, is approved based on an abbreviated data package that relies in part on the full testing required of the originator product. Globally, governments have or are developing regulatory pathways to approve biosimilars as alternatives to innovator-developed biologics, but the patent for the existing, branded product must expire in a given market before biosimilars may enter that market. 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31 | LLY | 2015 | Biosimilars may present both competitive challenges and opportunities. For example, with our partner Boehringer Ingelheim we have developed Basaglar, a new insulin glargine product which has the same amino acid sequence as the product currently marketed by a competitor. Our product has launched in the EU and Japan, and can be launched in the U.S. on December 15, 2016. | [-0.0127042131498456, -0.03491809219121933, -0.0018545192433521152, -0.004529532976448536, 0.006399183999747038, 0.018185384571552277, -0.011769387871026993, -0.002920489525422454, -0.03997556492686272, -0.01914038695394993, -0.006150345783680677, 0.01339692622423172, -0.007182689383625984, -0.012784917838871479, -0.0007154106278903782, 0.0022260956466197968, 0.0261751189827919, -0.00999389123171568, 0.014701646752655506, -0.019920529797673225, 0.008958185091614723, 0.005807352252304554, 0.018037427216768265, -0.0013072426663711667, -0.01701517216861248, 0.012482276186347008, 0.0029087201692163944, -0.031663015484809875, -0.00845378264784813, 0.016073621809482574, -0.014903407543897629, 0.0016788190696388483, -0.02795061469078064, 0.03381513059139252, -0.001025618053972721, -0.01920764148235321, -2.7479418349685147e-05, 0.012522628530859947, 0.03115188702940941, -0.01180301420390606, 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32 | LLY | 2015 | U.S. Private Sector Payer Consolidation | [-0.00621248921379447, -0.00539216585457325, 0.019371982663869858, -0.03558623790740967, -0.0068955197930336, 0.017683284357190132, -0.018342288210988045, 0.005268602631986141, -0.020085904747247696, -0.0189326461404562, 0.019879965111613274, 0.018795354291796684, 0.037178829312324524, 0.011354096233844757, 0.0036725765094161034, 0.000577057886403054, 0.010475424118340015, -0.01765582524240017, 0.019426900893449783, -0.022419877350330353, -0.0055260262452065945, 0.004705703351646662, -0.03803004324436188, -0.0013909453991800547, 0.02320244535803795, 0.0047297291457653046, -0.00466794753447175, -0.02620915323495865, 0.026964262127876282, 0.010866708122193813, 0.01639273390173912, -0.009981170296669006, -0.010386183857917786, -0.015376769006252289, -0.004067292902618647, -0.0069710309617221355, -0.002574235899373889, 0.00950751081109047, 0.029984699562191963, -0.019001293927431107, 0.010276349261403084, -0.00416339747607708, 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33 | LLY | 2015 | In the U.S. private sector, consolidation and integration among healthcare providers is also a major factor in the competitive marketplace for human pharmaceuticals. 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34 | LLY | 2015 | Payers typically maintain formularies which specify coverage (the conditions under which drugs are included on a plan's formulary) and reimbursement (the associated out-of-pocket cost to the consumer). Formulary placement can lead to reduced usage of a drug for the relevant patient population due to coverage restrictions, such as prior authorizations and formulary exclusions, or due to reimbursement limitations which result in higher consumer out-of-pocket cost, such as non-preferred co-pay tiers, increased co-insurance levels, and higher deductibles. Consequently, pharmaceutical companies compete for formulary placement not only on the basis of product attributes such as efficacy, safety profile, or patient ease of use, but also by providing rebates. Price is an increasingly important factor in formulary decisions, particularly in treatment areas in which the payer has taken the position that multiple branded products are therapeutically comparable. 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35 | LLY | 2015 | Intellectual property protection is critical to our ability to successfully commercialize our life sciences innovations and invest in the search for new medicines. We own, have applied for, or are licensed under, a large number of patents in the U.S. and many other countries relating to products, product uses, formulations, and manufacturing processes. In addition, as discussed below, for some products we have additional effective intellectual property protection in the form of data protection under pharmaceutical regulatory laws. | [0.004318978637456894, 0.00442312890663743, 0.012211611494421959, -0.047336265444755554, 0.0065028783865273, 0.023954546079039574, 0.0007184736896306276, 0.01908552460372448, 0.010154644958674908, -0.0119707640260458, 0.005318169482052326, 0.013227075338363647, -0.0004446725361049175, -0.0006419883575290442, -0.008208338171243668, 0.03379674255847931, 0.02937035635113716, -0.01849967986345291, 0.00837758183479309, -0.005152180325239897, -0.024384167045354843, 0.01715874671936035, -0.0014402020024135709, 0.012810475192964077, -0.011319825425744057, 0.005445102695375681, 0.005594818852841854, -0.024410203099250793, -0.004384072497487068, -0.028172628954052925, -0.0013515115715563297, -0.007082213647663593, -0.029083944857120514, -0.0014084686990827322, -0.009373518638312817, -0.020035894587635994, 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36 | LLY | 2015 | The patent protection anticipated to be of most relevance to human pharmaceuticals is provided by national patents claiming the active ingredient (the compound patent), particularly those in major markets such as the U.S., various European countries, and Japan. These patents may be issued based upon the filing of international patent applications, usually filed under the Patent Cooperation Treaty (PCT). Patent applications covering the compounds are generally filed during the Discovery Research Phase of the drug discovery process, which is described in the “Research and Development” section below. In general, national patents in each relevant country are available for a period of 20 years from the filing date of the PCT application, which is often years prior to the launch of a commercial product. 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37 | LLY | 2015 | •Patent term adjustment is a statutory right available to all U.S. patent applicants to provide relief in the event that a patent is delayed during examination by the United States Patent and Trademark Office (USPTO). | [-0.010507497936487198, -0.015111161395907402, 0.018786132335662842, -0.030010050162672997, -0.019369881600141525, 0.005230531562119722, -0.004683265928179026, 0.004995041526854038, -0.02272644266486168, -0.0032487669959664345, 0.02579113095998764, 0.013187440112233162, -0.02019243873655796, 0.005797697696834803, -0.011403023265302181, -0.006985097657889128, 0.019157608970999718, 0.00046185890096239746, 0.01922394521534443, -0.021068062633275986, -0.015801047906279564, 0.003674970706924796, -0.05102504417300224, 0.01243785209953785, -0.0018656778847798705, -0.005671660415828228, 0.01068660244345665, -0.03332681208848953, 0.007204004097729921, -0.0020099568646401167, 0.005001674871891737, 0.012159244157373905, -0.02844453789293766, 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38 | LLY | 2015 | •Patent term restoration is a statutory right provided to U.S. patents that claim inventions subject to review by the U.S. Food and Drug Administration (FDA). A single patent for a human pharmaceutical product may be eligible for patent term restoration to make up for a portion of the time invested in clinical trials and the FDA review process. Patent term restoration is limited by a formula and cannot be calculated until product approval due to uncertainty about the duration of clinical trials and the time it takes the FDA to review an application. There is a five-year cap on any restoration, and no patent may be extended for more than 14 years beyond FDA approval. Some countries outside the U.S. also offer forms of patent term restoration. For example, Supplementary Protection Certificates are sometimes available to extend the life of a European patent up to an additional five years. Similarly, in Japan, Korea, and Australia, patent terms can be extended up to five years, depending on the length of regulatory review and other factors. | [0.01341790147125721, -0.01264791190624237, 0.012219395488500595, -0.012413566932082176, -0.006923208478838205, -0.00039378259680233896, 0.000971693079918623, 0.0013617094373330474, -0.029406897723674774, 0.006862948182970285, 0.005192406475543976, 0.022014999762177467, -0.03650419041514397, 0.003990553319454193, -0.012842083349823952, 0.006611865013837814, 0.03152269497513771, 0.0013223729329183698, 0.016390729695558548, -0.010953934863209724, -0.014301714487373829, -0.003317649709060788, -0.06063498556613922, 0.019015388563275337, -0.0018429526826366782, 0.02134544402360916, 0.017167413607239723, -0.027933873236179352, -0.0008080702973529696, -0.0018831260967999697, 0.004465938080102205, 0.009507694281637669, -0.024987827986478806, -0.004184724763035774, -0.004057508893311024, -0.012996080331504345, -0.01419458631426096, 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39 | LLY | 2015 | Loss of effective patent protection for human pharmaceuticals typically results in the loss of effective market exclusivity for the product, which can result in severe and rapid decline in sales of the product. However, in some cases the innovator company may be protected from approval of generic or other follow-on versions of a new medicine beyond the expiration of the compound patent through manufacturing trade secrets, later-expiring patents on methods of use or formulations, or data protection that may be available under pharmaceutical regulatory laws. The primary forms of data protection are as follows: | [-0.006381271872669458, -0.01131179928779602, 0.01072347816079855, -0.029148608446121216, -0.011880063451826572, 0.02389383502304554, 0.0026925692800432444, -0.011238259263336658, -0.023960690945386887, -0.014119692146778107, 0.017181633040308952, 0.027704548090696335, -0.006585178431123495, 0.01438711117953062, -0.009045427665114403, 0.028667254373431206, 0.03297268971800804, -0.016833988949656487, 0.012882882729172707, -0.01058976911008358, -0.006327788345515728, 0.017596131190657616, -0.025057105347514153, 0.0048737009055912495, -0.008590816520154476, -0.008116149343550205, 0.006695488467812538, -0.03340056166052818, -0.010509544052183628, -0.013237211853265762, 0.0050441799685359, 0.020350541919469833, -0.01551026850938797, -0.006932822521775961, -0.002395066199824214, -0.0005494612851180136, -0.005391824059188366, -0.00565589964389801, 0.026915663853287697, -0.0010905656963586807, 0.017622873187065125, 0.01797051727771759, 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40 | LLY | 2015 | •Regulatory authorities in major markets generally grant data package protection for a period of years following new drug approvals in recognition of the substantial investment required to complete clinical trials. Data package protection prohibits other manufacturers from submitting regulatory applications for marketing approval based on the innovator company’s regulatory submission data for the drug. The base period of data package protection depends on the country. For example, the period is five years in the U.S. (12 years for new biologics as described below), 10 years in the EU, and eight years in Japan. 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41 | LLY | 2015 | •Under the Biologics Price Competition and Innovation Act of 2010, the FDA has the authority to approve biosimilars. A competitor seeking approval of a biosimilar must file an application to show its molecule is highly similar to an approved innovator biologic and include a certain amount of safety and efficacy data which the FDA will determine on a case-by-case basis. 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42 | LLY | 2015 | •In the U.S., the FDA has the authority to grant additional data protection for approved drugs where the sponsor conducts specified testing in pediatric or adolescent populations. 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43 | LLY | 2015 | •Under the U.S. orphan drug law, a specific use of a drug or biological product can receive "orphan" designation if it is intended to treat a disease or condition affecting fewer than 200,000 people in the U.S., or affecting more than 200,000 people but not reasonably expected to recover its development and marketing costs through U.S. sales. Among other benefits, orphan designation entitles the particular use of the drug to seven years of market exclusivity, meaning that the FDA cannot (with limited exceptions) approve another marketing application for the same drug for the same indication until expiration of the seven-year period. Unlike pediatric exclusivity, the orphan exclusivity period is independent of and runs in parallel with any applicable patents. | [0.0005307144019752741, -0.01123060192912817, 0.0003119147731922567, -0.029877008870244026, -0.005688790697604418, 0.0029228960629552603, -0.014230328612029552, -0.002857757266610861, -0.030732164159417152, 0.01623460091650486, 0.016929414123296738, 0.013936368748545647, -0.005120913963764906, -0.0043693119660019875, -0.024599093943834305, 0.046766337007284164, 0.02848738059401512, -0.01559323351830244, -0.004713378846645355, 0.005461640190333128, -0.019040580838918686, 0.01644838973879814, -0.026095615699887276, -0.004566398914903402, -0.014083348214626312, 0.009473524056375027, 0.011016813106834888, -0.031159741804003716, 0.015138931572437286, -0.001677742344327271, -0.0003064865304622799, 0.012232737615704536, -0.014871695078909397, -0.0068612899631261826, -0.009379991330206394, -0.00977416429668665, -0.00010658131941454485, -0.013936368748545647, 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44 | LLY | 2015 | Outside the major markets, the adequacy and effectiveness of intellectual property protection for human pharmaceuticals varies widely. Under the Trade-Related Aspects of Intellectual Property Agreement (TRIPs) administered by the World Trade Organization, more than 140 countries have agreed to provide non-discriminatory protection for most pharmaceutical inventions and to assure that adequate and effective rights are available to patent owners. 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45 | LLY | 2015 | countries, with many developing countries limiting protection for biopharmaceutical products under their interpretation of “flexibilities” allowed under the agreement. Thus, certain types of patents, such as those on new uses of compounds or new forms of molecules, are not available in many developing countries. 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46 | LLY | 2015 | Certain of our Elanco animal health products are covered by patents or other forms of intellectual property protection. 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47 | LLY | 2015 | There is no assurance that the patents we are seeking will be granted or that the patents we hold will be found valid and enforceable if challenged. Moreover, patents relating to particular products, uses, formulations, or processes do not preclude other manufacturers from employing alternative processes or marketing alternative products or formulations that compete with our patented products. In addition, competitors or other third parties may assert claims that our activities infringe patents or other intellectual property rights held by them, or allege a third-party right of ownership in our existing intellectual property. | [-0.010942116379737854, -0.013755066320300102, -0.002200036309659481, -0.026890767738223076, -0.007167860399931669, 0.03254247456789017, -0.007238829508423805, 0.010167909786105156, -0.016026072204113007, -0.01361312810331583, 0.0016088975826278329, 0.012187298387289047, 0.002662947168573737, -0.009329186752438545, -0.0027613360434770584, 0.02988436445593834, 0.03664576634764671, -0.0270198006182909, 0.020619696006178856, -0.011200184933841228, -0.014013134874403477, 0.003021017648279667, -0.025226224213838577, -0.004606527741998434, -0.030374696478247643, -0.010838888585567474, 0.007071084808558226, -0.03452960401773453, -0.004306522663682699, -0.012413108721375465, 0.0010822759941220284, -0.006248490419238806, -0.023548776283860207, 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48 | LLY | 2015 | We consider intellectual property protection for certain products, processes, uses, and formulations—particularly with respect to those products discussed below—to be important to our operations. For many of our products, in addition to the compound patent, we hold other patents on manufacturing processes, formulations, or uses that may extend exclusivity beyond the expiration of the compound patent. | [-0.00840731617063284, 0.0246488768607378, 0.015830297023057938, -0.04403896629810333, -0.007631982676684856, 0.02907165139913559, 0.00579477846622467, 0.004695826675742865, 0.006526289042085409, -0.03157968819141388, 0.012061499059200287, 0.031363941729068756, -0.0022400408051908016, 0.008899484761059284, -0.012304211966693401, 0.03735087066888809, 0.03473496064543724, -0.011724397540092468, 0.00983662810176611, -0.0029193006921559572, -0.007153298240154982, 0.010989516042172909, 0.00017792650032788515, -0.003576649120077491, -0.013497552834451199, -0.005292496643960476, 0.009007357992231846, -0.033278681337833405, -0.00949952658265829, -0.010133277624845505, 0.003433380974456668, -0.010652413591742516, -0.025592761114239693, 0.001202610321342945, -0.008690482005476952, 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49 | LLY | 2015 | The most relevant U.S. patent protection or data protection for our top-selling or recently launched patent-protected marketed products is as follows: | [-0.022575905546545982, -0.001870252308435738, 0.014071738347411156, -0.03484050929546356, -0.0016227677697315812, 0.009048964828252792, -0.015493528917431831, 0.004275336861610413, -0.011952340602874756, -0.015148047357797623, 0.01457667350769043, 0.016078190878033638, -0.012789469212293625, -0.014098313637077808, -0.007095664273947477, 0.03643503785133362, 0.019772186875343323, -0.0069960057735443115, 0.011613503098487854, -0.006175486836582422, -0.019253965467214584, 0.0099724642932415, -0.013041936792433262, 0.01160021498799324, 0.002755549270659685, -0.004285302944481373, 0.0015563289634883404, -0.03616928309202194, -0.0058167171664536, -0.011101923882961273, 0.018058067187666893, -0.006976074073463678, -0.019014785066246986, 0.003820231184363365, -0.006909635383635759, -0.005049348808825016, 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50 | LLY | 2015 | •Alimta is protected by a compound patent (July 2016) plus pediatric exclusivity (January 2017), and a vitamin regimen patent (2021) plus pediatric exclusivity (2022). | [-0.0006803542491979897, -0.008755721151828766, 0.002162715420126915, -0.04220572113990784, -0.014313244260847569, 0.03227033466100693, -0.01160657312721014, -0.01460160594433546, -0.025677330791950226, -0.003086784854531288, 0.03276841714978218, 0.019936304539442062, 0.002046387642621994, -0.009876400232315063, -0.008251086808741093, 0.0009207925177179277, 0.024759816005825996, -0.015309403650462627, -0.0005550150526687503, 0.03216547891497612, -0.01517833024263382, 0.00690102856606245, -0.000983871635980904, -0.01274036057293415, 0.005763964261859655, -0.010177870281040668, 0.002505145501345396, -0.03457723185420036, 0.007831651717424393, -0.006334134843200445, 0.0079627251252532, 0.012353693135082722, -0.01820613257586956, -0.020513027906417847, -0.028416769579052925, 0.013225332833826542, 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51 | LLY | 2015 | •Cialis is protected by compound and use patents (November 2017). | [-0.010926537215709686, -0.009061984717845917, 0.02779877930879593, -0.017537223175168037, 0.010398464277386665, 0.023704586550593376, -0.013899389654397964, -0.0015613995492458344, -0.016624504700303078, -0.02190522849559784, 0.019779900088906288, 0.03609147295355797, 0.0050232079811394215, -0.004860222805291414, 0.006617204751819372, 0.021853074431419373, 0.0080645140260458, -0.01752418279647827, 0.01414712704718113, -0.004511434119194746, -0.002082952531054616, 0.007895009592175484, -0.015437970869243145, -0.0037519223988056183, 0.003846453968435526, -0.004156126175075769, 0.014707797206938267, -0.0366651825606823, 0.0005810427246615291, 0.006092391908168793, -0.005561059806495905, 0.011656710878014565, -0.040133509784936905, -0.04008135572075844, -0.012849763967096806, 0.0035921968519687653, -0.001486426219344139, 0.0059033287689089775, 0.026221081614494324, 0.007921087555587292, 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53 | LLY | 2015 | •Effient is protected by a compound patent (April 2017) and patents covering methods of using Effient with aspirin (2023). | [-0.02959052287042141, 0.0074043371714651585, 0.0033953313250094652, -0.03283662721514702, 0.01028156653046608, 0.02249469794332981, 0.0017060491954907775, -0.005321867298334837, -0.017223132774233818, -0.006881204899400473, 0.022373976185917854, 0.02678706869482994, -0.0010772841051220894, 0.003584799123927951, -0.0006216390756890178, 0.013990441337227821, 0.016015904024243355, -0.004942931700497866, 0.01091200765222311, 0.02757847309112549, -0.013225863687694073, 0.01265578344464302, -0.014285542070865631, -0.014929397962987423, -0.0023054718039929867, 0.011924738995730877, -0.0012030370999127626, -0.03541204705834389, -0.013628273271024227, -0.007525060325860977, 0.010221204720437527, 0.00330143584869802, -0.023728754371404648, -0.008484136313199997, -0.002635783050209284, -0.03476819396018982, -0.0087993573397398, -0.010670562274754047, 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54 | LLY | 2015 | •Forteo is protected by patents primarily covering its formulation and related processes (2018) and use patents (2019). | [-0.012338644824922085, -0.007850654423236847, -0.012904638424515724, -0.031109632924199104, -0.003104637609794736, 0.0071648042649030685, -0.018711060285568237, 0.00879619549959898, -0.01562140416353941, 0.0034758623223751783, 0.022293461486697197, 0.012684899382293224, -0.006132699549198151, -0.0007278835400938988, 0.015434958972036839, 0.01443614810705185, 0.013796909712255001, -0.007511058822274208, 0.000698751537129283, -0.0030480383429676294, 0.011093460954725742, 0.02162758819758892, -0.008936028927564621, -0.005999524611979723, -0.008736266754567623, -0.0018128419760614634, 0.013996671885251999, -0.03036385402083397, -0.006279191933572292, -0.0008789536659605801, -0.004980737343430519, -0.005360285751521587, -0.013756956905126572, 0.0059296078979969025, -0.008050416596233845, -0.017712248489260674, -0.005363615229725838, 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55 | LLY | 2015 | •Jardiance, and the related combination products Glyxambi and Synjardy, are protected by a compound patent (2025 not including possible patent extension). | [-0.01688362844288349, -0.010461634024977684, 0.017479216679930687, -0.013918634504079819, -9.280775702791288e-05, 0.021221062168478966, -0.010785323567688465, -0.01173049584031105, -0.02760421298444271, -0.0004976721247658134, 0.02294308878481388, 0.0019421350443735719, -0.009115087799727917, -0.007101740688085556, 0.0061727529391646385, 0.02931329235434532, 0.01861860230565071, -0.0007991076563484967, 0.03021962195634842, -0.02324088290333748, 0.01543350052088499, 0.012559140101075172, -0.013556103222072124, -0.011458597145974636, 0.011963551864027977, 0.007464272435754538, -0.002050570910796523, -0.006360492669045925, -0.014967387542128563, 0.02672377973794937, -0.002633211435750127, 0.013077042996883392, -0.02659430354833603, -0.00604003993794322, -0.0018935817060992122, -0.005363529548048973, 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56 | LLY | 2015 | •Portrazza is protected by a compound patent (2025 not including possible patent extension), and by biologics data package protection (2027). | [-0.026363924145698547, -0.009059208445250988, 0.02211911603808403, -0.013426072895526886, 0.0006717274081893265, 0.00987969059497118, -0.010571337305009365, 0.0003337447124067694, -0.023787204176187515, -0.0076420120894908905, 0.002907287096604705, 0.014673748053610325, -0.02114267461001873, -0.01369052566587925, 0.012456411495804787, 0.030676541849970818, 0.005200908053666353, 0.00968982744961977, 0.02560446970164776, -0.00853030290454626, 0.006411288864910603, 0.005702690687030554, -0.008455713279545307, -0.01719622313976288, -0.01164271030575037, 0.014917858876287937, 0.022932816296815872, -0.01881006360054016, -0.0004907636321149766, -0.008292973041534424, 0.01428045891225338, 0.011819012463092804, -0.010822228156030178, 0.0012637799372896552, 0.01780649833381176, -0.004017650615423918, -0.004353302530944347, 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57 | LLY | 2015 | •Strattera is protected by a patent covering its use in treating attention deficit-hyperactivity disorder (2016) plus pediatric exclusivity (May 2017). | [-0.02216179110109806, 0.017305467277765274, 0.021211082115769386, -0.035818591713905334, -0.011427775025367737, 0.02158365584909916, -0.024422936141490936, -0.015455439686775208, -0.010303626768290997, -0.0007997515494935215, 0.010843218304216862, 0.0159179475158453, -0.00785619392991066, 0.012127959169447422, 0.011312148533761501, 0.009809001348912716, 0.015571066178381443, -0.01690719835460186, -0.011280030012130737, -0.00943000242114067, 0.000691351480782032, 0.011524130590260029, -0.007123891264200211, 0.001943171489983797, -0.014992932789027691, -0.010592693462967873, 0.004027664661407471, -0.014491884037852287, -0.0012911651283502579, 0.008941800333559513, 0.0018179091857746243, -0.005662498064339161, -0.007849770598113537, -0.04550554230809212, -0.013926597312092781, -0.005495481658726931, 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58 | LLY | 2015 | •Trajenta and Jentadueto are protected by a compound patent (2023), and Boehringer Ingelheim has applied for a patent extension to 2025 under the patent restoration laws. | [-0.02727198228240013, -0.02482709474861622, 0.024935156106948853, -0.013440129347145557, 0.01142748724669218, 0.020342547446489334, -0.011184348724782467, -0.008813753724098206, -0.022746913135051727, -0.0043325843289494514, 0.0057441359385848045, 0.02041008695960045, 0.0021713576279580593, 0.0017323584761470556, 0.00948913674801588, 0.025043217465281487, 0.020693747326731682, -0.007503509521484375, 0.024394849315285683, -0.004616245627403259, 0.0033161325845867395, 0.001459672348573804, -0.01639830879867077, 0.003717985702678561, 0.0032823632936924696, -0.0038294238038361073, 0.021868914365768433, -0.02960880845785141, -0.006547842174768448, 0.00477833766490221, -0.0036605780478566885, 0.022003991529345512, -0.03971254453063011, 1.2445785614545457e-05, -0.008212662301957607, 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59 | LLY | 2015 | •Trulicity is protected by a compound patent (2024 not including possible patent extension) and by biologics data package protection (2026). | [-0.012067776173353195, -0.023057015612721443, 0.01640165224671364, -0.004060954786837101, 0.011791565455496311, 0.01782216504216194, -0.026621447876095772, -0.00853622518479824, -0.015415186062455177, 0.001620271592400968, 0.014494484290480614, 0.033092670142650604, -0.006395592354238033, -0.009838361293077469, 0.015152128413319588, 0.024082940071821213, 0.02086048200726509, -0.012133540585637093, 0.0336977019906044, -0.0062147402204573154, 0.013718463480472565, 0.009009729139506817, -0.011653459630906582, -0.0009157698950730264, -0.007530029397457838, 0.02161019667983055, -0.0012215746100991964, -0.027989348396658897, 0.0033868690952658653, 0.009128104895353317, -0.006885537412017584, 0.009739714674651623, -0.016796240583062172, -0.01563878543674946, -0.010772216133773327, -0.027805207297205925, 0.00995673704892397, 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60 | LLY | 2015 | Outside the U.S., important patent protection or data protection includes: | [0.0028089494444429874, -0.009628770872950554, 0.02346259541809559, -0.04009532555937767, 0.011778169311583042, 0.020730648189783096, -0.002758729737251997, 0.009454675950109959, 0.012816040776669979, -0.02429289184510708, 0.01611044630408287, 0.01399452704936266, -0.0008210903615690768, -0.004332276992499828, -0.00019041597261093557, 0.023234933614730835, 0.020328892394900322, 0.0003871093795169145, 0.03264943137764931, -0.004292101599276066, -0.026609688997268677, 0.01727554015815258, -0.015454243868589401, 0.010284973308444023, 0.005242925602942705, -0.003923824522644281, 0.009260493330657482, -0.03487248718738556, 0.01023140549659729, -0.029649648815393448, 0.02114579826593399, -0.013124054297804832, -0.01746302656829357, -0.01692735217511654, -0.008657858707010746, -0.015655122697353363, 0.0030081537552177906, -0.025377634912729263, 0.040497083216905594, -0.007807473186403513, 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61 | LLY | 2015 | •Cymbalta in Japan (data package protection 2018). 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62 | LLY | 2015 | •Forteo in Japan (data package protection 2018; patent covering its formulation and related process 2019). | [-0.01675795018672943, -0.0059670512564480305, -0.013229960575699806, -0.01413909625262022, -0.0050782691687345505, 0.011072458699345589, -0.01981101743876934, 0.0066251568496227264, 0.005061307922005653, 0.00013060345372650772, 0.020421631634235382, 0.019431080669164658, -0.0066726491786539555, -0.010251522995531559, -0.0006843960145488381, 0.0069881328381598, 0.01137776579707861, -0.0024729848373681307, -0.0030988636426627636, 0.002227043267339468, 0.007252731826156378, 0.02127648890018463, -0.0010007277596741915, 0.0003131514531560242, -0.004206448793411255, 0.005844928324222565, 0.011560949496924877, -0.03620259836316109, -0.0033363245893269777, -0.0017622985178604722, 0.007340931799262762, -0.004057187587022781, -0.006967778783291578, -0.0068727945908904076, -0.004097895231097937, -0.023678235709667206, -0.010733229108154774, -0.029499419033527374, 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63 | LLY | 2015 | •Zyprexa in Japan (patent for schizophrenia expired December 2015; patent for bipolar mania will expire April 2016). | [-0.012660271488130093, -0.0025012395344674587, 0.027772611007094383, -0.021255619823932648, -0.010122972540557384, 0.01598433032631874, -0.028375793248414993, 0.005392580758780241, -0.007965940050780773, -0.016548175364732742, 0.005238506942987442, 0.03304389864206314, 0.00022844709747005254, 0.004612377379089594, 0.00230782781727612, 0.0014186257030814886, 0.016272809356451035, 0.00022393961262423545, 0.02483537420630455, -0.0028339731507003307, 0.003191293217241764, 0.010824499651789665, -0.0001336876448476687, -0.008510115556418896, -0.003269969252869487, 0.018108580261468887, 0.0011203127214685082, -0.008962501771748066, -0.00668745581060648, -0.0035436959005892277, 0.019550973549485207, 0.022396421059966087, -0.017820103093981743, -0.0003460512380115688, -0.005386024247854948, -0.019393621012568474, -0.003206044901162386, -0.0172955971211195, 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64 | LLY | 2015 | U.S. patent protection or data protection for our new molecular entities that have been submitted for regulatory review is as follows (additional information about these molecules is provided in Item 7, "Management’s Discussion and Analysis—Late-Stage Pipeline”): | [-0.013883903622627258, -0.015285391360521317, 0.004492621403187513, -0.03976559266448021, -0.008834615349769592, 0.018730171024799347, -0.013530256226658821, 0.008022538386285305, -0.004430405795574188, 0.00596287427470088, 0.003824622370302677, 0.001707654562778771, 0.0035888580605387688, 0.005412757396697998, 0.005373463500291109, 0.009830065071582794, 0.013196256943047047, -0.020459109917283058, 0.026850944384932518, 0.0061265998519957066, -0.008029087446630001, 0.007046735845506191, -0.012168061919510365, -0.0071253241039812565, 0.0009627045947127044, 0.0055175418965518475, 0.006810971535742283, -0.03523368015885353, -0.0056517962366342545, -0.015508057549595833, 0.0012770571047440171, 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65 | LLY | 2015 | Worldwide, we sell all of our major products under trademarks that we consider in the aggregate to be important to our operations. Trademark protection varies throughout the world, with protection continuing in some countries as long as the mark is used, and in other countries as long as it is registered. 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66 | LLY | 2015 | Most of our major products were discovered in our own laboratories and are not subject to significant license agreements. 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67 | LLY | 2015 | •The compound patent for Cialis is the subject of a license agreement with GlaxoSmithKline (Glaxo), which assigns to us exclusively all rights in the compound. The agreement calls for royalties of a single-digit percentage of net sales. 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68 | LLY | 2015 | •The compound patent for Alimta is the subject of a license agreement with Princeton University, granting us an irrevocable exclusive worldwide license to the compound patents for the lives of the patents in the respective territories. The agreement calls for royalties of a single-digit percentage of net sales. The agreement is not subject to termination by Princeton for any reason other than a material breach by Lilly of the royalty obligation, after a substantial cure period. Alimta is also the subject of a worldwide, nonexclusive license to certain patents owned by Takeda Pharmaceutical Company Limited. The agreement calls for royalties of a single-digit percentage of net sales in countries covered by a relevant patent. The agreement is subject to termination for material default and failure to cure by Lilly and in the event that Lilly becomes bankrupt or insolvent. | [-0.0028459220193326473, -0.007328123785555363, 0.018109500408172607, -0.03905655816197395, -0.009476368315517902, 0.029446342960000038, -0.026381246745586395, -0.006451426073908806, -0.0244136955589056, -0.01829688623547554, 0.026769403368234634, 0.02888418547809124, 0.009723985567688942, 0.0036807928700000048, 0.006170347332954407, 0.0069265831261873245, 0.02514985390007496, -0.014897172339260578, -0.0002576555125415325, 0.003115289146080613, -0.002365746069699526, 0.004109103232622147, -0.017426881939172745, -0.0037510625552386045, -0.01156438235193491, -0.0076225874945521355, 0.007261200342327356, -0.013705934397876263, 0.00510626332834363, -0.012173386290669441, 0.00037790866917930543, 0.01868504285812378, -0.03712916001677513, -0.006414617877453566, -0.012213540263473988, 0.0015099616721272469, 0.0054910737089812756, 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69 | LLY | 2015 | In the U.S., the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, made a complex set of changes to both patent and new-drug-approval laws for human pharmaceuticals. Before the Hatch-Waxman Act, no drug could be approved without providing the FDA complete safety and efficacy studies, i.e., a complete New Drug Application (NDA). The Hatch-Waxman Act authorizes the FDA to approve generic versions of innovative human pharmaceuticals (other than biologics) without such information by filing an Abbreviated New Drug Application (ANDA). 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70 | LLY | 2015 | Absent a patent challenge, the FDA cannot approve an ANDA until after the innovator’s patents expire. However, after the innovator has marketed its product for four years, a generic manufacturer may file an ANDA alleging that one or more of the patents listed in the innovator’s NDA are invalid or not infringed. This allegation is commonly known as a “Paragraph IV certification.” The innovator must then file suit against the generic manufacturer to protect its patents. The FDA is then prohibited from approving the generic company’s application for a 30- to 42-month period (which can be shortened or extended by the trial court judge hearing the patent challenge). If one or more of the NDA-listed patents are challenged, the first filer(s) of a Paragraph IV certification may be entitled to a 180-day period of market exclusivity over all other generic manufacturers. | [-0.006708142347633839, -0.012431479059159756, -0.00809428934007883, 0.006620454136282206, -0.02049204148352146, -0.0034535634331405163, -0.044113874435424805, -0.008377589285373688, -0.03860975801944733, 0.013025060296058655, 0.01752413623034954, 0.014556230045855045, -0.004748649429529905, 0.0030825750436633825, 0.011358985677361488, 0.012654071673750877, 0.023837681859731674, 0.004536174703389406, 0.010670971125364304, -0.0019207074074074626, -0.02471456304192543, 0.016998007893562317, -0.03056943230330944, 0.00019972237350884825, -0.006849792320281267, 0.013544443994760513, 0.010367435403168201, -0.027237283065915108, -0.011966057121753693, -0.014826039783656597, 0.007021795958280563, 0.006728378124535084, -0.024377301335334778, -0.0007647416787222028, -0.00618875864893198, 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71 | LLY | 2015 | Generic manufacturers use Paragraph IV certifications extensively to challenge patents on innovative human pharmaceuticals. In addition, generic companies have shown an increasing willingness to launch “at risk,” i.e., after receiving ANDA approval but before final resolution of their patent challenge. We are currently in litigation with numerous generic manufacturers in Hatch-Waxman litigation involving Alimta and Effient, among other products. For more information on Hatch-Waxman litigation involving the company, see Item 8, “Financial Statements and Supplementary Data—Note 15, Contingencies” and Item 3, "Legal Proceedings." | [-0.004554146435111761, -0.01096152514219284, -0.011277261190116405, -0.012828485108911991, -0.018285224214196205, 0.02255452238023281, -0.01326776947826147, 0.0008468241430819035, -0.023639006540179253, -0.019026516005396843, 0.01661045104265213, 0.015416146256029606, -0.0032414402812719345, -0.0011599860154092312, 0.0036000751424580812, 0.009588760323822498, 0.029734080657362938, -0.007618843112140894, 0.006836367305368185, 0.0062975576147437096, -0.02064637839794159, 0.02097584307193756, -0.019026516005396843, 0.00044014264130964875, -0.013219722546637058, 0.015004316344857216, 0.0138992415741086, -0.03448384627699852, -0.013858058489859104, -0.011634179390966892, 0.0025722174905240536, 0.00795517023652792, -0.016843821853399277, 0.005714132450520992, -0.0029342842753976583, -0.011469447985291481, 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72 | LLY | 2015 | The passage of the America Invents Act in 2011 added a new procedure to U.S. patent law. This procedure, inter partes review (IPR), allows any member of the public to file a petition with the USPTO seeking the review of any issued U.S. patent. IPRs are conducted before Administrative Patent Judges in the USPTO using a lower standard of proof than used in Federal District Court. In addition, the challenged patents are not accorded the presumption of validity as they are in Federal District Court. We are now seeing instances where generic drug companies and some investment funds are attempting to invalidate our patents by filing IPR challenges in the USPTO. 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73 | LLY | 2015 | Outside the U.S., the legal doctrines and processes by which pharmaceutical patents can be challenged vary widely. In recent years, we have experienced an increase in patent challenges from generic manufacturers in many countries outside the U.S., and we expect this trend to continue. For more information on administrative challenges and litigation involving our Alimta patents in Europe and Japan, see Item 8, “Financial Statements and Supplementary Data—Note 15, Contingencies.” | [0.007444916758686304, -0.019202478229999542, 0.0030135756824165583, -0.029674159362912178, -0.001253733178600669, 0.025691227987408638, -0.0015521233435720205, 0.008889059536159039, -0.027168340981006622, -0.01885957643389702, 0.008829711005091667, 0.004945693071931601, -0.005779866594821215, -0.007708687335252762, 0.013162137940526009, 0.008625288493931293, 0.031019387766718864, -0.020376255735754967, 0.018490297719836235, 0.010082620196044445, -0.021035682410001755, -0.001046014134772122, -0.009957329370081425, 0.012865396216511726, 0.003041601274162531, 0.0029624702874571085, 0.009442976675927639, -0.04143831506371498, 0.005328160244971514, -0.01706593856215477, -0.00970674678683281, 0.002538789063692093, -0.008579129353165627, -0.001641145907342434, -0.01673622615635395, 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74 | LLY | 2015 | Our operations are regulated extensively by numerous national, state, and local agencies. The lengthy process of laboratory and clinical testing, data analysis, manufacturing development, and regulatory review necessary for governmental approvals is extremely costly and can significantly delay product introductions. Promotion, marketing, manufacturing, and distribution of human pharmaceutical and animal health products are extensively regulated in all major world markets. We conduct extensive post-marketing surveillance of the safety of the products we sell. In addition, our operations are subject to complex federal, state, local, and foreign laws and regulations concerning the environment, occupational health and safety, and privacy. Animal health product regulations address the administration of the product in or on the animal, and in the case of food animal products, the impact on humans who consume the food as well as the impact on the environment at the production site. The laws and regulations affecting the manufacture and sale of current products and the discovery, development, and introduction of new products will continue to require substantial effort, expense, and capital investment. | [0.015583685599267483, -0.0018984782509505749, -0.014369715005159378, -0.02302585169672966, -0.007376189809292555, 0.01782689243555069, 0.0018720875959843397, 0.026047583669424057, -0.025876043364405632, -0.0028369962237775326, -0.013960660435259342, -0.013003998436033726, -0.021284068003296852, -0.00740917818620801, -0.01613788865506649, 0.014739184640347958, 0.04789905250072479, -0.021719515323638916, -0.007105685770511627, -0.0007632673950865865, -0.018724175170063972, 0.017853282392024994, -0.006257885601371527, 0.00040493172127753496, -0.01641499064862728, 0.01492391899228096, 0.021521585062146187, -0.028950555250048637, -0.0036584055051207542, -0.016850437968969345, -0.012100118212401867, -0.009817326441407204, -0.011888992972671986, -0.002385056111961603, 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75 | LLY | 2015 | Of particular importance is the FDA in the U.S. Pursuant to the Federal Food, Drug, and Cosmetic Act, the FDA has jurisdiction over all of our human pharmaceutical products and certain animal health products in the U.S. and administers requirements covering the testing, safety, effectiveness, manufacturing, quality control, distribution, labeling, marketing, advertising, dissemination of information, and post-marketing surveillance of those products. The U.S. Department of Agriculture and the U.S. Environmental Protection Agency also regulate some animal health products. | [0.016300085932016373, -0.003514419309794903, -0.01972271129488945, -0.02006366103887558, -0.018529381603002548, 0.011035013943910599, -0.0074943676590919495, 0.019276851788163185, -0.009854799136519432, 0.004799542482942343, 0.016050929203629494, -0.015709977596998215, -0.012575850822031498, 0.004579891450703144, -0.02479763701558113, 0.008353302255272865, 0.043982695788145065, -0.016129611060023308, -0.012503726407885551, -0.007946783676743507, -0.009172896854579449, 0.02397148683667183, -0.012693872675299644, 0.009808901697397232, -0.005406042095273733, 0.03716367110610008, 0.022017573937773705, -0.034908149391412735, -0.005533898714929819, -0.013978996314108372, -0.0050814831629395485, -0.017427846789360046, -0.022791270166635513, -0.009874468669295311, 0.02701381966471672, 0.0029538169037550688, 0.0021342227701097727, -0.014896941371262074, 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76 | LLY | 2015 | The FDA extensively regulates all aspects of manufacturing quality for human pharmaceuticals under its current Good Manufacturing Practices (cGMP) regulations. Outside the U.S., our products and operations are subject to similar regulatory requirements, notably by the European Medicines Agency in the EU and the Ministry of Health, Labor and Welfare in Japan. Specific regulatory requirements vary from country to country. We make substantial investments of capital and operating expenses to implement comprehensive, company- | [0.03051164746284485, -0.002822721377015114, -0.011658495292067528, -0.026257872581481934, -0.009649768471717834, 0.019745919853448868, -0.006236244924366474, 0.026179099455475807, -0.02305441163480282, -0.010319343768060207, 0.002189250197261572, -0.003049195511266589, -0.013398079201579094, -0.007293124217540026, -0.020848751068115234, 0.016332397237420082, 0.025194428861141205, -0.014061090536415577, 0.0016156797064468265, 0.0008607658674009144, -0.008632275275886059, 0.03048538975417614, -0.014323669485747814, -0.00797582883387804, -0.004693594761192799, 0.02862108126282692, 0.0029080593958497047, -0.02943507581949234, -0.006295324768871069, -0.007234043907374144, -0.011737269349396229, -0.01035216636955738, -0.017369583249092102, 0.013069855980575085, 0.01431054063141346, -0.013371821492910385, -0.015334597788751125, -0.005622467026114464, 0.012144265696406364, 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77 | LLY | 2015 | wide quality systems in our manufacturing, product development, and process development operations to ensure sustained compliance with cGMP and similar regulations. However, in the event we fail to adhere to these requirements in the future, we could be subject to interruptions in production, fines and penalties, and delays in new product approvals. Certain of our products are manufactured by third parties, and their failure to comply with these regulations could adversely affect us through failure to supply product to us or delays in new product approvals. | [-0.006504892371594906, -0.015090269036591053, -0.012057354673743248, -0.0069844843819737434, -0.014752528630197048, 0.030531788244843483, 0.0016118690837174654, 0.026073606684803963, -0.008247636258602142, -0.010152495466172695, 0.010294346138834953, 0.010942809283733368, 0.0011778718326240778, -0.00744381221011281, -0.016684407368302345, 0.0025583882816135883, 0.037637859582901, -0.0035226389300078154, -0.004046137444674969, -0.016576329246163368, -0.004171101842075586, 0.016441233456134796, -0.025236010551452637, -0.012395096011459827, -0.01727883145213127, 0.013448847457766533, 0.008065255358815193, -0.030477751046419144, -0.013131371699273586, -0.0034787326585501432, -0.0013467423850670457, -0.00456288130953908, -0.00866643525660038, 0.013651492074131966, 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78 | LLY | 2015 | The marketing, promotional, and pricing practices of human pharmaceutical manufacturers, as well as the manner in which manufacturers interact with purchasers and prescribers, are subject to various other U.S. federal and state laws, including the federal anti-kickback statute and the False Claims Act and state laws governing kickbacks, false claims, unfair trade practices, and consumer protection. These laws are administered by, among others, the Department of Justice (DOJ), the Office of Inspector General of the Department of Health and Human Services, the Federal Trade Commission, the Office of Personnel Management, and state attorneys general. Over the past several years, the FDA, the DOJ, and many of these other agencies have increased their enforcement activities with respect to pharmaceutical companies and increased the inter-agency coordination of enforcement activities. Several claims brought by these agencies against Lilly and other companies under these and other laws have resulted in corporate criminal sanctions and very substantial civil settlements. | [-0.001395628903992474, -0.0036746086552739143, -0.0034020505845546722, -0.026979969814419746, -0.015683583915233612, 0.007230999413877726, 0.006764695048332214, 0.010764403268694878, -0.0338628813624382, -0.014632758684456348, 0.011808661743998528, -0.0008394297328777611, -0.0035235523246228695, 0.010436019860208035, -0.004722151439636946, -0.005832086782902479, 0.02560075931251049, -0.03278578445315361, -0.0018947714706882834, -0.006357499863952398, -0.033731527626514435, 0.019033094868063927, -0.036332324147224426, 0.015053088776767254, -0.016143321990966797, 0.014015397988259792, 0.03987886384129524, -0.03672638535499573, 0.0029488815926015377, 0.001263454556465149, -0.014264969155192375, -0.006616922561079264, -0.016642464324831963, -0.013581931591033936, -0.0022543510422110558, 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79 | LLY | 2015 | The U.S. Foreign Corrupt Practices Act of 1977 (FCPA) prohibits certain individuals and entities, including U.S. publicly traded companies, from promising, offering, or giving anything of value to foreign officials with the corrupt intent of influencing the foreign official for the purpose of helping the company obtain or retain business or gain any improper advantage. The FCPA also imposes specific recordkeeping and internal controls requirements on U.S. publicly traded companies. As noted above, outside the U.S., our business is heavily regulated and therefore involves significant interaction with foreign officials. Additionally, in many countries outside the U.S., the health care providers who prescribe human pharmaceuticals are employed by the government and the purchasers of human pharmaceuticals are government entities; therefore, our interactions with these prescribers and purchasers are subject to regulation under the FCPA. | [0.0005330188432708383, -0.013550742529332638, 0.016229378059506416, -0.04356721416115761, -0.0034730343613773584, 0.0014238456496968865, -0.01980089209973812, 0.011751855723559856, 0.002031954936683178, -0.01770000159740448, 0.016465727239847183, 0.009007567539811134, 0.01141046080738306, 0.006292823236435652, -0.013550742529332638, 0.005915319547057152, 0.025880342349410057, -0.03251127898693085, 0.00028989824932068586, 0.005393379367887974, -0.01131854671984911, 0.026733828708529472, -0.05541098117828369, 0.019905935972929, -0.015349630266427994, 0.017555564641952515, 0.017358606681227684, -0.036555491387844086, 0.01567789353430271, -0.006827893666923046, 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80 | LLY | 2015 | In addition to the U.S. application and enforcement of the FCPA, the various jurisdictions in which we operate and supply our products have laws and regulations aimed at preventing and penalizing corrupt and anticompetitive behavior. In recent years, several jurisdictions, including China, Brazil, and the United Kingdom (U.K.), have enhanced their laws and regulations in this area, increased their enforcement activities, and/or increased the level of cross-border coordination and information sharing. | [-0.003882862161844969, -0.007177906576544046, 0.007648161146789789, -0.04247962310910225, -0.007282407488673925, 0.015440010465681553, -0.011188129894435406, 0.02012948878109455, -0.0046470253728330135, -0.03315291553735733, 0.01278176810592413, 0.0010735836112871766, 0.020847933366894722, -0.0001561390672577545, -0.005979411769658327, -0.008118415251374245, 0.02740536630153656, -0.02221950702369213, -0.00839926116168499, 0.013480618596076965, -0.007380377501249313, 0.0287377517670393, -0.03869146481156349, -0.002615788485854864, -0.01772596873342991, 0.007086468394845724, 0.023238390684127808, -0.036627572029829025, 0.006263523828238249, -0.0021945193875581026, -0.004163708537817001, -0.004784182645380497, 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81 | LLY | 2015 | It is possible that we could become subject to additional administrative and legal proceedings and actions, which could include claims for civil penalties (including treble damages under the False Claims Act), criminal sanctions, and administrative remedies, including exclusion from U.S. federal and other health care programs. It is possible that an adverse outcome in future actions could have a material adverse impact on our consolidated results of operations, liquidity, and financial position. | [-0.004983203019946814, -0.012098783627152443, -0.0018863342702388763, -0.04658425226807594, -0.021743692457675934, 0.021113820374011993, -0.019670365378260612, 0.004107287619262934, -0.00010215934889856726, -0.0033691569697111845, 0.015589321963489056, 0.026192160323262215, 0.01208566129207611, 0.005429361946880817, 0.0006290514720603824, -0.016730964183807373, 0.03587643802165985, -0.03241214156150818, 0.015379364602267742, -0.021192554384469986, -0.01432957872748375, 0.006013305392116308, -0.04739783704280853, 0.0034938189201056957, -0.011626379564404488, -0.007158228196203709, 0.024118833243846893, -0.02033960446715355, 0.012977979145944118, -0.00801117904484272, 0.00801117904484272, -0.01079967338591814, -0.0040679206140339375, -0.009835182689130306, -0.001068649347871542, -0.0054490454494953156, 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82 | LLY | 2015 | In the U.S., we are required to provide rebates to the federal government and respective state governments on their purchases of our human pharmaceuticals under state Medicaid and Medicaid Managed Care programs (minimum of 23.1 percent plus adjustments for price increases over time) and rebates to private payers who cover patients in certain types of health care facilities that serve low-income and uninsured patients (known as 340B facilities). No rebates are required at this time in the Medicare Part B (physician and hospital outpatient) program where reimbursement is set on an "average selling price plus 4.3 percent" formula. Drug manufacturers are required to provide a discount of 50 percent of the cost of branded prescription drugs for Medicare Part D participants who are in the “doughnut hole” (the coverage gap in Medicare prescription drug coverage). 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83 | LLY | 2015 | Rebates are also negotiated in the private sector. We give rebates to private payers who provide prescription drug benefits to seniors covered by Medicare and to private payers who provide prescription drug benefits to their customers. 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84 | LLY | 2015 | In most international markets, we operate in an environment of government-mandated cost-containment programs, which may include price controls, international reference pricing (to other countries’ prices), discounts and rebates, therapeutic reference pricing (to other, often generic, pharmaceutical choices), restrictions on physician prescription levels, and mandatory generic substitution. | [0.002451061038300395, -0.02710624225437641, -0.0028648334555327892, -0.027598116546869278, 0.005799459759145975, 0.02097775973379612, 0.002748511964455247, 0.01397187914699316, -0.016604069620370865, -0.003632555715739727, -0.003343413583934307, 0.01698959246277809, 0.0070391152985394, -0.0053773787803947926, -0.009604835882782936, 0.01466316170990467, 0.03203827515244484, -0.022519851103425026, 0.010661700740456581, 0.0017913517076522112, -0.011838209815323353, 0.01885073632001877, -0.008966729044914246, -0.010708228684961796, -0.02646813541650772, 0.0019010263495147228, 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85 | LLY | 2015 | Globally, public and private payers are increasingly restricting access to human pharmaceuticals based on assessments of comparative effectiveness and value, including through the establishment of formal health technology assessment processes. In addition, third party organizations, including professional associations, academic institutions, and non-profit entities associated with payers, are conducting and publishing comparative effectiveness and cost/benefit analyses on medicines, the impact of which are uncertain at this time. | [-0.0003299943055026233, -0.004050793591886759, 0.01500049140304327, -0.049481797963380814, -0.0042556459084153175, 0.014273595064878464, 0.0033932828810065985, 0.010460695251822472, -0.02495235949754715, -0.007942991331219673, -0.007724922616034746, -0.0014116652309894562, 0.01842351071536541, -0.004083834122866392, -0.003697257721796632, 0.013295589946210384, 0.0435873307287693, -0.008141235448420048, -0.010764669626951218, -0.0027341204695403576, -0.02427832782268524, 0.01878035068511963, -0.03782502934336662, -0.002838198794052005, -0.016308903694152832, 0.023842191323637962, 0.02167471870779991, -0.027542753145098686, 0.001942794886417687, -0.0117360670119524, 0.004443978425115347, 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86 | LLY | 2015 | We cannot predict the extent to which our business may be affected by these or other potential future legislative or regulatory developments. 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87 | LLY | 2015 | Our commitment to research and development dates back more than 100 years. We invest heavily in research and development because we believe it is critical to our long-term competitiveness. At the end of 2015, we employed approximately 8,730 people in human pharmaceutical and animal health research and development activities, including a substantial number of physicians, scientists holding graduate or postgraduate degrees, and highly skilled technical personnel. 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88 | LLY | 2015 | Our internal human pharmaceutical research focuses primarily on the areas of cancer, diabetes, neurodegeneration, immunology, and pain. We have a strong biotechnology research program, with more than half of our clinical-stage pipeline currently consisting of biologics. In addition to discovering and developing NMEs, we seek to expand the value of existing products through new uses, formulations, and therapeutic approaches that provide additional value to patients. Across all our therapeutic areas, we are increasingly focusing our efforts on tailored therapeutics, seeking to identify and use advanced diagnostic tools and other information to identify specific subgroups of patients for whom our medicines—or potentially those of other companies—will be the best treatment option. | [-0.022462477907538414, -0.005934188142418861, 0.010472096502780914, -0.01882944069802761, -0.0004291356890462339, 0.03307691588997841, -0.01163114421069622, 0.021974459290504456, -0.01518284622579813, 0.007272854447364807, -0.003843157785013318, 0.0064459312707185745, 0.010851668193936348, -0.012722411192953587, -0.006689941510558128, 0.0027230840642005205, 0.034920547157526016, -0.008215004578232765, -0.010831333696842194, -0.013149429112672806, -0.026366638019680977, 0.013583225198090076, 0.012308950535953045, -0.0003397500840947032, -0.009916296228766441, 0.02131020836532116, -0.0011649783700704575, -0.035815250128507614, -0.009333383291959763, -0.012024272233247757, 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89 | LLY | 2015 | To supplement our internal efforts, we collaborate with others, including academic institutions and research-based pharmaceutical and biotechnology companies. We use the services of physicians, hospitals, medical schools, and other research organizations worldwide to conduct clinical trials to establish the safety and effectiveness of our human pharmaceutical products. We actively seek out external investments in research and technologies that hold the promise to complement and strengthen our own efforts. These investments can take many forms, including licensing arrangements, co-development and co-marketing agreements, co-promotion arrangements, joint ventures, and acquisitions. | [0.003372455947101116, -0.008210022933781147, 0.0015571024268865585, -0.020254991948604584, -0.007453836966305971, 0.050286393612623215, 0.00895270612090826, 0.019525811076164246, 0.0039936089888215065, 0.003895709989592433, -0.008142506703734398, 0.00948608759790659, 0.015866409987211227, -0.003242486622184515, -0.01074189692735672, 0.0020373144652694464, 0.037431225180625916, -0.035621777176856995, -0.013037462718784809, -0.013793649151921272, -0.02816794067621231, 0.00020571475033648312, -0.01669011265039444, 0.009202517569065094, -0.018675101920962334, 0.021281244233250618, 0.01723024621605873, -0.03148975968360901, 0.012861919589340687, -0.01078240666538477, 0.002084576291963458, 0.012686376459896564, -0.012125988490879536, -0.01071489043533802, 0.01245006825774908, -0.0224155243486166, 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90 | LLY | 2015 | Our Elanco animal health innovation strategy is focused on identifying and developing promising technologies and potential products from internal and external sources to meet unmet veterinary needs. Our animal health scientists also leverage discoveries from our human health laboratories to develop products to enhance the health and wellbeing of farm animals and pets. | [-0.010281979106366634, -0.0071512265130877495, -0.002371477894484997, -0.023025745525956154, 0.006224711425602436, 0.02702615037560463, -0.0312807634472847, -0.0061009530909359455, -0.033635515719652176, 0.007532536052167416, 0.004829921294003725, 0.003629130544140935, -0.013740523718297482, -0.01012811716645956, 0.005485505796968937, 0.027614839375019073, 0.02691911719739437, -0.020670991390943527, -0.00612771138548851, 0.003284613834694028, -0.025005878880620003, 0.018329616636037827, 0.003943543415516615, -0.007037502713501453, 0.0018346341094002128, 0.0012701957020908594, 0.01439610868692398, -0.021072370931506157, 0.004923576023429632, -0.009077843278646469, -0.0032946483697742224, 0.001393117825500667, -0.013419420458376408, -0.00618791813030839, -0.020336510613560677, -0.02129981853067875, 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91 | LLY | 2015 | Human pharmaceutical development is time-consuming, expensive, and risky. On average, only one out of many thousands of molecules discovered by researchers ultimately becomes an approved medicine. The process from discovery to regulatory approval can take over a decade. Drug candidates can fail at any stage of the process, and even late-stage drug candidates sometimes fail to receive regulatory approval or achieve commercial success. After approval and launch of a product, we expend considerable resources on post-marketing surveillance and additional clinical studies to collect data and understand the benefits and potential risks of medicines as they are used as therapeutics. 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92 | LLY | 2015 | The earliest phase of new drug research and development, the discovery phase, can take many years. Scientists identify, design, and synthesize promising molecules, screening tens of thousands of molecules for their effect on biological “targets” that appear to play an important role in one or more diseases. Targets can be part of the body, such as a protein, receptor, or gene; or foreign, such as a virus or bacteria. Some targets have been proven to affect disease processes, but often the target is unproven and may later prove to be irrelevant to the disease or to yield insufficient clinical benefit. Molecules that have the desired effect on the target and meet other design criteria become “candidate” molecules and move to the next phase of development. 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93 | LLY | 2015 | The early development phase involves refining candidate molecules, understanding how to manufacture them efficiently, and completing initial testing for safety and efficacy. Safety testing is done first in laboratory tests and animals as necessary, to identify toxicity and other potential safety issues that would preclude use in humans. In general, the first human tests (often referred to as Phase I) are conducted in small groups of healthy volunteers to assess safety and find the potential dosing range. After a safe dose has been established, the drug is typically administered to small populations of patients (Phase II) to look for initial signs of efficacy in treating the targeted disease, or biomarkers of the disease, and to continue to assess safety. In parallel, scientists work to identify safe, effective, and economical manufacturing processes. Long-term animal studies continue to test for potential safety issues. Of the molecules that enter the early development phase, approximately 10 percent move on to the product phase. 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94 | LLY | 2015 | Product phase (Phase III) molecules have already demonstrated safety and, typically, shown initial evidence of efficacy. As a result, these molecules generally have a higher likelihood of success. The molecules are tested in much larger patient populations to demonstrate efficacy to a predetermined level of statistical significance and to continue to develop the safety profile. These trials are generally global in nature and are designed to generate the data necessary to submit the molecule to regulatory agencies for marketing approval. The potential new drug is generally compared with existing competitive therapies, placebo, or both. The resulting data is compiled and may be submitted to regulatory agencies around the world. 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95 | LLY | 2015 | Once a molecule is submitted to regulatory agencies, the time to final marketing approval can vary from several months to several years, depending on variables such as the disease state, the strength and complexity of the data presented, the novelty of the target or compound, and the time required for the agency(ies) to evaluate the submission. 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96 | LLY | 2015 | We believe our investments in research, both internally and in collaboration with others, have been rewarded by the large number of new molecules and new indications for existing molecules that we have in all stages of development. We currently have approximately 50 drug candidates across all stages of human testing and a larger number of projects in preclinical development. Among our new investigational molecules currently in the product phase of development or awaiting regulatory approval or launch are potential therapies for various cancers, Alzheimer’s disease, pain, migraines, rheumatoid arthritis, psoriasis, psoriatic arthritis, and severe hypoglycemia. We are studying many other drug candidates in the earlier stages of development in our chosen priority areas. We are also developing new uses, formulations, or delivery methods for many of these molecules as well as several currently marketed products. See Item 7, "Management's Discussion and Analysis—Late-Stage Pipeline," for more information on certain of our product candidates. | [-0.002582052955403924, -0.011390052735805511, -0.004880508873611689, -0.032712601125240326, -0.006944832392036915, 0.02673727460205555, -0.009431254118680954, 0.024943357333540916, -0.011508767493069172, 0.004534256644546986, 0.015525294467806816, 0.0033240222837775946, 0.003604321740567684, -0.004461708478629589, -0.00417151628062129, 0.015617628581821918, 0.03751396760344505, 0.000625727407168597, -0.007149286102503538, -0.013302684761583805, -0.005239951889961958, 0.003996741026639938, 0.0014682747423648834, -0.008771725930273533, -0.017780881375074387, 0.03487585484981537, 0.00835622288286686, -0.01944289170205593, 0.0016405765200033784, -0.014245809987187386, -0.010400759987533092, 0.0016727284528315067, -0.0034823091700673103, -0.003429546719416976, -0.004619995132088661, -0.021263189613819122, 0.014483240433037281, 0.012122129090130329, 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97 | LLY | 2015 | Most of the principal materials we use in our manufacturing operations are available from more than one source. However, we obtain certain raw materials principally from only one source. In the event one of these suppliers was unable to provide the materials or product, we generally seek to maintain sufficient inventory to supply the market until an alternative source of supply can be implemented. 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98 | LLY | 2015 | The majority of our revenue comes from products produced in our own facilities. Our principal active ingredient manufacturing occurs at four owned sites in the U.S. as well as owned sites in Ireland, Puerto Rico, and the U.K. Finishing operations, including formulation, filling, assembling, delivery device manufacturing, and packaging, take place at a number of sites throughout the world. 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99 | LLY | 2015 | We manage our supply chain (including our own facilities, contracted arrangements, and inventory) in a way that should allow us to meet all expected product demand while maintaining flexibility to reallocate manufacturing capacity to improve efficiency and respond to changes in supply and demand. 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