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300 | LLY | 2015 | For acquired IPR&D assets, the risk of failure has been factored into the fair value measure and there can be no certainty that these assets ultimately will yield a successful product, as discussed previously in the “Late-Stage Pipeline” section. The nature of the pharmaceutical business is high-risk and requires that ... | [-0.0014971899800002575, -0.017759772017598152, 0.0009467769996263087, -0.02899119444191456, -0.011291377246379852, 0.02332885190844536, -0.01650739461183548, 0.016307547688484192, -0.001648740959353745, 0.0038870316930115223, 0.02346208319067955, 0.014428981579840183, -0.003927001263946295, 0.011204777285456657, -0.00... |
301 | LLY | 2015 | Estimates of future cash flows, based on what we believe to be reasonable and supportable assumptions and projections, require management’s judgment. Actual results could vary materially from these estimates. | [-0.01650219038128853, -0.03779859468340874, -0.003141472116112709, -0.03191937506198883, -0.005037079099565744, -0.006819139234721661, -0.02914377674460411, 0.006298714783042669, -0.00737425871193409, -0.0010526770493015647, -0.007847372442483902, 0.006074774544686079, -0.04229001700878143, 0.020085236057639122, 0.007... |
302 | LLY | 2015 | We prepare and file tax returns based on our interpretation of tax laws and regulations and record estimates based on these judgments and interpretations. In the normal course of business, our tax returns are subject to examination by various taxing authorities, which may result in future tax, interest, and penalty ass... | [-0.008706987835466862, -0.03158997744321823, 0.00459699984639883, -0.04109329730272293, -0.011609316803514957, 0.0005088125471957028, -0.024653345346450806, -0.019440999254584312, -0.011971285566687584, -0.014399765059351921, 0.03488060086965561, 0.006433167494833469, -0.015110539272427559, 0.02716738171875477, -0.022... |
303 | LLY | 2015 | We have recorded valuation allowances against certain of our deferred tax assets, primarily those that have been generated from net operating losses and tax credit carryforwards in certain taxing jurisdictions. In evaluating whether we would more likely than not recover these deferred tax assets, we have not assumed an... | [-0.02077649161219597, -0.025346795096993446, 0.010086185298860073, -0.02763194590806961, -0.005033242981880903, 0.007039316929876804, -0.016797175630927086, -0.013330049812793732, -0.010132151655852795, 0.008746613748371601, 0.03254370763897896, 0.009219404309988022, -0.008871378377079964, 0.018543872982263565, -0.007... |
304 | LLY | 2015 | As of December 31, 2015, a 5 percent change in the amount of the uncertain tax positions and the valuation allowance would result in a change in net income of $20.2 million and $29.5 million, respectively. | [-0.01694459840655327, -0.028365181758999825, 0.014041278511285782, -0.028082557022571564, -0.004666509106755257, -0.008099749684333801, -0.04319009929895401, -0.020323241129517555, -0.025795871391892433, 0.0013231945922598243, 0.034248899668455124, 0.0027058045379817486, -0.0003376233798917383, 0.035225238651037216, 0... |
305 | LLY | 2015 | To determine whether acquisitions or licensing transactions qualify as a business combination or as an asset acquisition, we make certain judgments, which include assessing whether the acquired set of activities would meet the definition of a business under the relevant accounting rules. This involves determining the i... | [-0.004426717292517424, -0.014488632790744305, 0.02832048200070858, -0.035282380878925323, -0.020097559317946434, 0.018022125586867332, -0.00847906805574894, -0.006988171022385359, 0.0067221736535429955, -0.035072211176157, -0.0022281361743807793, 0.024721311405301094, 0.0029292521066963673, 0.01176955085247755, -0.003... |
306 | LLY | 2015 | If the acquired set of activities meets the definition of a business, assets acquired and liabilities assumed are required to be recorded at their respective fair values as of the acquisition date. The excess of the purchase price over the fair value of the acquired net assets, where applicable, is recorded as goodwill... | [-0.013828077353537083, -0.009445189498364925, 0.011037150397896767, -0.030480386689305305, -0.006307894829660654, 0.01757151633501053, -0.008932298980653286, -0.00545862689614296, 0.01610611379146576, -0.01346172671765089, 0.009218718856573105, 0.02688348852097988, 0.0062179723754525185, 0.015173584222793579, -0.00350... |
307 | LLY | 2015 | The judgments made in determining estimated fair values assigned to assets acquired and liabilities assumed in a business combination, as well as estimated asset lives, can materially affect our consolidated results of operations. The fair values of intangible assets, including acquired IPR&D, are determined using info... | [-0.011525843292474747, -0.009592856280505657, 0.019736122339963913, -0.04109726473689079, -0.013275359757244587, 0.01770484820008278, -0.020758312195539474, 0.004200150724500418, 0.01805868372321129, -0.01818973384797573, 0.005900524090975523, 0.0164598748087883, -0.015241109766066074, 0.009284889325499535, -0.0072011... |
308 | LLY | 2015 | The fair values of identifiable intangible assets are primarily determined using an "income method," as described in Note 8 to the consolidated financial statements. | [-0.03160446137189865, -0.014712853357195854, 0.014049210585653782, -0.027021564543247223, -0.010217607021331787, 0.004717504605650902, -0.05569597706198692, -0.005947749596089125, 0.014324684627354145, -0.022438667714595795, 0.01431216299533844, 0.027347125113010406, 0.0009125099750235677, 0.014462422579526901, -0.017... |
309 | LLY | 2015 | The fair value of any contingent consideration liability that results from a business combination is determined using a market approach based on quoted market values, significant other observable inputs for identical or comparable assets or liabilities, or a discounted cash flow analysis. Estimating the fair value of c... | [-0.024502158164978027, -0.026152966544032097, 0.009781365282833576, -0.014597306959331036, -0.0004655084921978414, -0.013843393884599209, -0.03621380031108856, -0.01576717011630535, -0.01211459469050169, -0.027270836755633354, -0.001891280640847981, 0.0394374243915081, -0.03842354193329811, 0.028232725337147713, -0.00... |
310 | LLY | 2015 | As of December 31, 2015, a 5 percent change in the contingent consideration liability would result in a change in income before income taxes of $33.5 million. | [-0.019632134586572647, -0.015032680705189705, 0.0125380614772439, -0.020892437547445297, 0.011615571565926075, -0.011959880590438843, -0.03960208222270012, -0.018137961626052856, -0.017826134338974953, -0.0025904413778334856, 0.032482024282217026, 0.03643183782696724, -0.005960451439023018, 0.0282723531126976, 0.01292... |
311 | LLY | 2015 | Information relating to certain legal proceedings can be found in Note 15 to the consolidated financial statements and is incorporated here by reference. | [-0.02026607282459736, -0.008763877674937248, 0.008732330054044724, -0.026726987212896347, 0.004072774201631546, -0.0009921669261530042, -0.012719926424324512, -0.012795640155673027, -0.0039434293285012245, -0.015243721194565296, 0.023812005296349525, 0.009521015919744968, -0.00859983079135418, 0.017489898949861526, 0.... |
312 | LLY | 2015 | For the full year of 2016, we expect EPS to be in the range of $2.83 to $2.93. We anticipate that total revenue will be between $20.2 billion and $20.7 billion. Excluding the unfavorable impact of foreign exchange rates, we expect revenue growth from a number of established products including Humalog, Trajenta, Cialis,... | [-0.010271772742271423, -0.010957436636090279, 0.019712837412953377, -0.0286396536976099, 0.029008857905864716, -0.0034942487254738808, -0.017062481492757797, -0.003174491925165057, -0.03243717551231384, -0.016838323324918747, 0.009757524356245995, 0.029641777276992798, -0.01893487200140953, -0.013607791624963284, 0.01... |
313 | LLY | 2015 | We anticipate that gross margin as a percent of revenue will be approximately 74 percent in 2016. Research and development expenses are expected to be in the range of $4.8 billion to $5.0 billion. Other—net, (income) expense is expected to be income of up to $75 million. Marketing, selling, and administrative expenses ... | [-0.0030894463416188955, -0.010174727067351341, -0.0018369246972724795, -0.024548139423131943, 0.007721201051026583, -0.0006902554305270314, -0.007837115786969662, -0.003258488606661558, -0.017348553985357285, 0.009562955237925053, 0.028824100270867348, 0.03626839444041252, -0.007257542572915554, -0.012866522185504436,... |
314 | LLY | 2015 | The 2016 tax rate is expected to be approximately 21 percent. | [-0.00929044745862484, -0.0035903446841984987, 0.016452355310320854, -0.03433208540081978, -0.010511226952075958, -0.019895579665899277, -0.03863924369215965, -0.017504103481769562, -0.02674446813762188, -0.0022866143845021725, 0.01945735141634941, 0.009572166018188, 0.010304633527994156, 0.0021301042288541794, 0.00862... |
315 | LLY | 2015 | Capital expenditures are expected to be approximately $1.1 billion. | [0.005224714986979961, -0.006594866514205933, -0.004810106474906206, -0.013682081364095211, -0.012548386119306087, 0.019292252138257027, -0.029696334153413773, -0.014744515530765057, 0.007041866425424814, 0.007670257706195116, 0.01771155744791031, 0.03399789705872536, -0.015806948766112328, 0.009017734788358212, 0.0032... |
316 | LLY | 2015 | Amortization associated with the transfer of Erbitux commercialization rights included in our 2016 financial guidance is subject to final acquisition accounting adjustments. | [-0.011303810402750969, -0.022660940885543823, 0.015142840333282948, -0.045108601450920105, -0.008144608698785305, 0.00923100020736456, -0.028232865035533905, -0.004102296661585569, 0.013150010257959366, -0.00948426965624094, 0.011057205498218536, 0.010763946920633316, -0.007991313934326172, -0.006575005128979683, -0.0... |
317 | LLY | 2015 | Various risks and uncertainties, including those discussed in "Forward-Looking Statements" and Item 1A, “Risk Factors,” may cause our actual results to differ materially from these forward-looking statements. | [-0.01460208185017109, -0.023643851280212402, -0.018396619707345963, -0.02210349589586258, -0.018559422343969345, -0.004924758803099394, -0.02319301664829254, 0.01963641867041588, 0.00517522357404232, -0.0017986483871936798, -0.0012632805155590177, 0.0319342277944088, -0.01959884911775589, -0.0067437575198709965, 0.007... |
318 | LLY | 2015 | You can find quantitative and qualitative disclosures about market risk (e.g., interest rate risk) in Item 7 at “Management’s Discussion and Analysis—Financial Condition.” That information is incorporated in this report by reference. | [-0.026120105758309364, -0.015949668362736702, -0.0001798123266780749, -0.029350418597459793, -0.022952884435653687, 0.007892814464867115, -0.04398777335882187, -0.01170357409864664, -0.010448042303323746, -0.018650008365511894, 0.011640481650829315, 0.043710168451070786, -0.012050580233335495, 0.0014866061974316835, -... |
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0 | LLY | 2016 | 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... | [-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, 0.00... |
1 | LLY | 2016 | 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. Most of the products we sell today were discovered or developed by our own scient... | [0.005796090234071016, -0.009194706566631794, 0.002456751884892583, -0.006863097660243511, 0.00537455640733242, 0.00898393988609314, 0.0015552293043583632, 0.02573991008102894, -0.0047126165591180325, 0.011157473549246788, -0.02500222623348236, 0.017612211406230927, -0.012639428488910198, -0.012059819884598255, -0.0124... |
2 | LLY | 2016 | 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. Elanco companion animal products help pets l... | [0.008651016280055046, -0.010181127116084099, -0.007238605059683323, -0.016791993752121925, -0.0038775906432420015, 0.0072124493308365345, -0.008991040289402008, -0.004711305256932974, -0.01989145204424858, 0.002283724257722497, -0.014241808094084263, 0.018008237704634666, -0.014712612144649029, -0.0248479675501585, -0... |
3 | LLY | 2016 | We manufacture and distribute our products through facilities in the United States (U.S.), Puerto Rico, and 14 other countries. Our products are sold in approximately 125 countries. | [-0.008747166022658348, -0.013524812646210194, -0.008061874657869339, -0.013434302061796188, -0.0013746238546445966, 0.014804885722696781, 0.0001309165672864765, 0.023649025708436966, 0.009206182323396206, 0.004994224291294813, -0.013098121620714664, 0.012096043676137924, -0.030333852395415306, -0.025200629606842995, -... |
4 | LLY | 2016 | •Trulicity®, for the treatment of type 2 diabetes (approved in the U.S. and Europe in 2014 and Japan in 2015) | [-0.0018553818808868527, -0.031056635081768036, 0.008960136212408543, -0.004231175873428583, 0.009024783968925476, 0.020583748817443848, -0.016704902052879333, -0.016239440068602562, -0.006089789792895317, -0.001067491015419364, 0.01991141401231289, 0.020570818334817886, -0.014506887644529343, -0.019807979464530945, -0... |
5 | LLY | 2016 | •Jardiance®, for the treatment of type 2 diabetes (approved in the U.S., Europe, and Japan in 2014, cardiovascular data included in the European label in 2016) and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and established cardiovascular disease (approved in the U.S. in 2016) | [-0.022184476256370544, -0.020656269043684006, 0.01495096180588007, -0.006857830565422773, 0.008277789689600468, 0.021407637745141983, -0.01696310192346573, 0.004014728125184774, -0.022897640243172646, -0.002406926592811942, 0.011359674856066704, 0.01440335437655449, -0.021866099908947945, -0.009869672358036041, -0.002... |
6 | LLY | 2016 | •Glyxambi®, a combination tablet of linagliptin and empagliflozin (Jardiance) for the treatment of type 2 diabetes (approved in the U.S. in 2015 and Europe in 2016) | [-0.011921137571334839, -0.02442190796136856, 0.021910160779953003, -0.015109123662114143, -0.008919921703636646, 0.015778923407197, -0.018780138343572617, -0.00968632660806179, -0.013131927698850632, -0.01196622010320425, 0.022863337770104408, -0.0049365488812327385, -0.009679886512458324, -0.009357866831123829, -0.01... |
7 | LLY | 2016 | •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), extended release formulation approved in the U.S. in 2016[DATA_TABLE_REMOVED] | [-0.00965161994099617, -0.021711289882659912, 0.0003095023857895285, -0.028844812884926796, -0.016131345182657242, 0.02900017239153385, -0.016752777621150017, -0.013147176243364811, -0.01791796274483204, 0.0018837165553122759, 0.02822338230907917, 0.007152944337576628, -0.015315716154873371, -0.006848701275885105, -0.0... |
8 | LLY | 2016 | ◦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, -... |
9 | LLY | 2016 | ◦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 | [-0.011380646377801895, -0.013733070343732834, 0.0014964914880692959, -0.040232811123132706, -0.008678537793457508, 0.011959215626120567, -0.025978391990065575, 0.0009362012497149408, -0.02708466723561287, 0.019785793498158455, 0.000563071807846427, 0.008258916437625885, 0.007890157401561737, 0.00336333061568439, -0.00... |
10 | LLY | 2016 | ◦approved in 2015 in the U.S., and in the EU in 2016, as a second-line treatment of metastatic colorectal cancer | [-0.008847905322909355, -0.007917545735836029, -0.0075061628594994545, -0.024050099775195122, -0.015670539811253548, 0.0058637941256165504, -0.02507539466023445, -0.013012370094656944, -0.008968155831098557, 0.032758768647909164, 0.010759254917502403, -0.004673947114497423, 0.010151674039661884, -0.009582065977156162, ... |
11 | LLY | 2016 | •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 | [-0.02331545762717724, -0.007604304235428572, 0.02004891261458397, -0.02753419429063797, 0.007326581981033087, 0.006724849808961153, -0.016980741173028946, -0.013410025276243687, -0.03419953212141991, 0.00728029478341341, 0.004546051379293203, 0.003871582681313157, -0.024201525375247, 0.009065653197467327, -0.007604304... |
12 | LLY | 2016 | •Lartruvo™, approved in the U.S., and conditionally approved in the EU, in 2016 for use in combination with another agent for the treatment of soft tissue carcinoma | [-0.0037619329523295164, -0.007497420068830252, -0.017057621851563454, -0.02372199483215809, -0.00148345110937953, 0.013738658279180527, -0.014532036148011684, -0.018221242353320122, -0.023470759391784668, 0.004026392009109259, 0.02472694031894207, -0.005226376000791788, 0.004912330769002438, -0.006674290634691715, -0.... |
13 | LLY | 2016 | •Taltz®, for the treatment of moderate-to-severe plaque psoriasis (approved the U.S. and EU in 2016) and psoriatic arthritis (approved in Japan in 2016) | [0.006280089728534222, -0.017029013484716415, 0.016503268852829933, -0.026389840990304947, -0.0240175761282444, 0.03190375491976738, -0.03485305607318878, -0.004927257541567087, -0.002588653704151511, -0.013034632429480553, 0.020093722268939018, -0.0056068794801831245, 0.003853327129036188, -0.013387266546487808, -0.01... |
14 | LLY | 2016 | On January 3, 2017 we completed the acquisition of Boehringer Ingelheim Vetmedica, Inc.'s U.S. feline, canine, and rabies vaccines portfolio—as well as a fully integrated manufacturing and research and development site and several pipeline assets—in an all-cash transaction for approximately $885 million, subject to fin... | [-0.01546355802565813, -0.005420216359198093, -0.012394758872687817, -0.03337152674794197, -0.026835383847355843, 0.008024045266211033, -0.011106129735708237, -0.027287069708108902, -0.013072285801172256, -0.006987827830016613, 0.006526179611682892, 0.014108504168689251, -0.004008701536804438, -0.01510486751794815, 0.0... |
15 | LLY | 2016 | We sell most of our products worldwide. We adapt our marketing methods and product emphasis in various countries to meet local customer needs. | [-0.02065546251833439, -0.007061642128974199, 0.0051160226576030254, -0.020757528021931648, -0.007284909952431917, 0.018193136900663376, 0.002057253383100033, 0.01134838443249464, 0.018869319930672646, -0.015386342070996761, -0.01852484978735447, 0.028246568515896797, -0.015182211063802242, -0.018971385434269905, -0.00... |
16 | LLY | 2016 | In the U.S., we distribute human pharmaceutical products principally through independent wholesale distributors, with some sales directly to pharmacies. In 2016, 2015, and 2014, three wholesale distributors in the U.S.—McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc.—each accounted for bet... | [-0.006626290734857321, -0.004800613038241863, 0.005940019618719816, -0.015826918184757233, 0.002374037867411971, 0.02579590678215027, 0.0035528477746993303, 0.013475866056978703, -0.002050603972747922, 0.0013052282156422734, 0.010848991572856903, 0.032336823642253876, -0.005007479339838028, 0.007959429174661636, -0.00... |
17 | LLY | 2016 | 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 cer... | [-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, -0.0190269... |
18 | LLY | 2016 | 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. We enter into arrangements with these organizations providing for discounts or rebates on our products. | [-0.0013540616491809487, -0.015715396031737328, -0.0010600604582577944, -0.01637793518602848, -0.030158720910549164, 0.032146334648132324, 0.024315137416124344, 0.021174708381295204, 0.004233616404235363, 0.0012936050770804286, 0.0023039751686155796, 0.027985597029328346, 0.006863891612738371, 0.0016960968496277928, -0... |
19 | LLY | 2016 | 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 consolidated revenue. Distribution patterns vary from country to country. In most countries in wh... | [-0.0015368934255093336, -0.00611809641122818, 0.0065078469924628735, -0.017568238079547882, 0.02341121807694435, 0.014738455414772034, -0.0075264377519488335, 0.00764434551820159, 0.0011152097722515464, 0.0073102740570902824, -0.0019847785588353872, 0.018537702038884163, -0.0018324812408536673, -0.004198822192847729, ... |
20 | LLY | 2016 | •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, 0.00... |
21 | LLY | 2016 | •We co-promote Cymbalta in Japan with Shionogi & Co. Ltd. | [0.002507579978555441, -0.008573662489652634, 0.01855742186307907, -0.004795663524419069, -0.01944871060550213, 0.03261849284172058, 0.004316762555390596, 0.00028039832250215113, 0.014899149537086487, -0.0020669244695454836, -0.00541091850027442, 0.04711855947971344, 0.014832635410130024, -0.023519370704889297, -0.0125... |
22 | LLY | 2016 | •Through September 30, 2015, Erbitux was marketed in the U.S. and Canada by Bristol-Myers Squibb Company and E.R. Squibb (collectively, BMS). Effective October 1, 2015, BMS transferred to us all commercialization rights for Erbitux in those two countries. Outside the U.S. and Canada, Erbitux is commercialized by Merck ... | [-0.019158294424414635, -0.007834513671696186, -0.01135645154863596, -0.040067754685878754, -0.021615155041217804, 0.02037365734577179, -0.01539459079504013, -0.013349384069442749, 0.006628952920436859, -2.25889561988879e-05, 0.015891190618276596, 0.0037604360841214657, -0.016244037076830864, 0.0002954686642624438, -0.... |
23 | LLY | 2016 | •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 has been exclusively promoting Effient in majo... | [-0.027590926736593246, 0.01085741724818945, 0.002919683698564768, -0.026963254436850548, -0.010917513631284237, 0.03255889564752579, 0.0007466143579222262, 0.0006222482188604772, -0.01770840771496296, -0.015384679660201073, 0.005595643073320389, 0.01794879324734211, -0.00029171796631999314, -0.005982930772006512, -0.0... |
24 | LLY | 2016 | For additional information, see Item 8, "Financial Statements and Supplementary Data—Note 4, Collaborations and Other Arrangements." | [-0.01872846484184265, -0.01261941809207201, -0.009791037999093533, -0.053764708340168, -0.02469099685549736, 0.010517243295907974, -0.01826980896294117, -0.003675620537251234, 0.004742633551359177, -0.020078953355550766, 0.019238082692027092, 0.023748204112052917, -0.009032980538904667, 0.008975648321211338, -0.005745... |
25 | LLY | 2016 | 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 co... | [-0.016912566497921944, -0.01831653155386448, -0.01300616655498743, -0.0013609026791527867, -0.003334414679557085, 0.022333428263664246, -0.009301261976361275, 0.00297854864038527, -0.01609358750283718, -0.002947674598544836, -0.00934676080942154, 0.010581729002296925, -0.016769571229815483, -0.01656157523393631, 0.013... |
26 | LLY | 2016 | Our human pharmaceutical products compete globally with products of many other companies in highly competitive markets. Our animal health products compete globally with products of animal health care companies as well as pharmaceutical, chemical, and other companies that operate animal health businesses. | [-0.002152522560209036, -0.0046298922970891, -0.00010971794108627364, 0.00037447657086886466, -0.0032386276870965958, 0.022640861570835114, 0.0016250560292974114, 0.018414568156003952, -0.020015833899378777, -0.0024101033341139555, -0.025016510859131813, 0.026709653437137604, -0.015212033875286579, -0.01809956505894661... |
27 | LLY | 2016 | 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 w... | [-0.0002840037923306227, -0.0013371673412621021, -0.004590226802974939, -0.003670202801004052, 0.004441835917532444, 0.022146524861454964, 0.002400635741651058, -0.0055597140453755856, -0.026446564123034477, -0.018123481422662735, -0.010585220530629158, 0.01663297601044178, -0.008824314922094345, -0.007379976566880941,... |
28 | LLY | 2016 | 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 productiv... | [-0.01753852516412735, -0.006048919167369604, 0.005557653494179249, -0.012498872354626656, -0.01577397808432579, 0.03173510357737541, -0.007980563677847385, 0.016910238191485405, -0.025572558864951134, 0.013528190553188324, -0.0070581864565610886, 0.02069331891834736, 0.003702874295413494, -0.011904005892574787, -0.022... |
29 | LLY | 2016 | 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, allo... | [0.009077885188162327, -0.017336007207632065, -0.009675910696387291, -0.008627686649560928, 0.009353380650281906, 0.03133919835090637, 0.01643560826778412, 0.013586590997874737, -0.02779136598110199, -0.02194550260901451, -0.006235586944967508, -0.010186583735048771, -0.0033260942436754704, -0.021434830501675606, -0.01... |
30 | LLY | 2016 | Several of our current products, including Cyramza, Erbitux, Trulicity, Portrazza, and Taltz, 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 subse... | [-0.015316679142415524, -0.013758021406829357, -0.004861527122557163, -0.006163782440125942, -0.005367584992200136, 0.023993881419301033, -0.015114255249500275, -0.012489503249526024, -0.019270675256848335, -0.01812361180782318, 0.017151981592178345, -0.007611107546836138, -0.014453006908297539, -0.016112877056002617, ... |
31 | LLY | 2016 | Biosimilars may present both competitive challenges and opportunities. For example, with our partner Boehringer Ingelheim, we developed Basaglar, a new insulin glargine product which has the same amino acid sequence as the product currently marketed by a competitor. This product has launched as a follow-on biologic in ... | [-0.01397975068539381, -0.036382000893354416, -0.0018707412527874112, 0.0020839690696448088, 0.008049351163208485, 0.01760462485253811, -0.01030823402106762, -0.004447799641638994, -0.03752810135483742, -0.024121399968862534, -0.0069032516330480576, 0.011074521578848362, -0.003335016779601574, -0.0167916938662529, 0.00... |
32 | LLY | 2016 | U.S. Private Sector Payer Consolidation | [-0.006228121463209391, -0.0053874109871685505, 0.019353501498699188, -0.03549514710903168, -0.006859512533992529, 0.01770639605820179, -0.018378963693976402, 0.0052947611548006535, -0.02002607099711895, -0.018955450505018234, 0.019861359149217606, 0.018777014687657356, 0.03719715774059296, 0.011268953792750835, 0.0036... |
33 | LLY | 2016 | In the U.S. private sector, consolidation and integration among healthcare providers is also a major factor in the competitive marketplace for human pharmaceuticals. Health plans and pharmaceutical benefit managers have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importa... | [0.0054802973754704, -0.010785069316625595, 0.020464977249503136, -0.018319666385650635, -0.013125410303473473, 0.026809900999069214, 0.0013465085066854954, 0.01503018755465746, -0.018098633736371994, -0.023481417447328568, 0.010804572142660618, 0.021908188238739967, 0.013977034017443657, 0.006500945892184973, -0.00964... |
34 | LLY | 2016 | 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 restrictio... | [0.012580236420035362, -0.004247608128935099, 0.004366161767393351, -0.02044542506337166, -0.03295114263892174, 0.026190197095274925, 0.00328901712782681, -0.006859175860881805, -0.03370988741517067, 0.005016513168811798, 0.024618513882160187, 0.006872724741697311, -0.0005610128282569349, 0.016380729153752327, -0.01094... |
35 | LLY | 2016 | 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, formulat... | [0.0045174057595431805, 0.0043318928219377995, 0.012354518286883831, -0.04723097383975983, 0.006515739485621452, 0.023940948769450188, 0.0007103197276592255, 0.01911109872162342, 0.010056760162115097, -0.012100658379495144, 0.005236675497144461, 0.013207227922976017, -0.0002695228031370789, -0.0005020243697799742, -0.0... |
36 | LLY | 2016 | 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 inter... | [0.015745924785733223, -0.0033540260046720505, 0.0276437196880579, -0.0354708693921566, 0.0032558594830334187, 0.006168135907500982, -0.007663540542125702, 0.0023249126970767975, -0.02806256338953972, 0.010091528296470642, 0.00992137286812067, 0.02054954506456852, -0.015012947842478752, 0.0201307013630867, -0.013651704... |
37 | LLY | 2016 | •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, -0.01... |
38 | LLY | 2016 | •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 a... | [0.013405095785856247, -0.012635072693228722, 0.012260105460882187, -0.012394022196531296, -0.006963686086237431, -0.00030445202719420195, 0.0010420420439913869, 0.0013082021614536643, -0.029408182948827744, 0.006819725502282381, 0.005118979141116142, 0.02201596274971962, -0.036479003727436066, 0.004094513598829508, -0... |
39 | LLY | 2016 | Loss of effective patent protection for human pharmaceuticals typically results in the loss of effective market exclusivity for the product, which often results in severe and rapid decline in revenues for the product. However, in some cases the innovator company may be protected from approval of generic or other follow... | [-0.005208474118262529, -0.011280009523034096, 0.011219796724617481, -0.028394047170877457, -0.009232748299837112, 0.02334948629140854, 0.0053556631319224834, -0.010711326263844967, -0.025878457352519035, -0.014143500477075577, 0.01691332459449768, 0.026601020246744156, -0.005703563801944256, 0.013822360895574093, -0.0... |
40 | LLY | 2016 | •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 marketi... | [0.005279149394482374, -0.015259730629622936, -0.0005644373595714569, -0.016229234635829926, -0.020425992086529732, 0.012470745481550694, -0.00416023563593626, 0.009535671211779118, -0.010970006696879864, -0.0012533830013126135, 0.008818503469228745, 0.019695544615387917, -0.0059265922755002975, -0.0059996373020112514,... |
41 | LLY | 2016 | •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 wh... | [-0.009747253730893135, -0.016306892037391663, -0.023788567632436752, -0.0033983667381107807, -0.015266306698322296, 0.01604345254600048, -0.02937348000705242, 0.002461510943248868, -0.03698687627911568, 0.0082324780523777, 0.01932327263057232, -0.00016001878248061985, 0.010471711866557598, -0.02335389330983162, -0.004... |
42 | LLY | 2016 | •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 within a specified time period. If granted, this “pediatric exclusivity” provides an additional six months of exclusivity, which is added to ... | [0.003885205602273345, -0.0011776710161939263, -0.005109778605401516, -0.04371623694896698, -0.018760869279503822, 0.011447541415691376, -0.008643644861876965, -0.00792049802839756, -0.018419763073325157, -0.012477683834731579, 0.028925850987434387, 0.00866411067545414, -0.007101842202246189, -0.004212668165564537, -0.... |
43 | LLY | 2016 | •Under the U.S. orphan drug law, a specific use of a drug or biologic 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 throu... | [-0.0022166993003338575, -0.00971758458763361, 0.0018959925509989262, -0.029724376276135445, -0.007809960283339024, 0.0026022123638540506, -0.015526865608990192, -0.0042871697805821896, -0.0281557384878397, 0.015606626868247986, 0.01698915660381317, 0.012150304391980171, -0.004898672923445702, -0.0054536787793040276, -... |
44 | LLY | 2016 | Outside the major markets, the adequacy and effectiveness of intellectual property protection for human pharmaceuticals varies widely, and in a number of these markets we are unable to patent our products or to enforce the patents we receive for our products. Under the Trade-Related Aspects of Intellectual Property Agr... | [-0.005581229459494352, -0.010919938795268536, 0.013908830471336842, -0.03198637813329697, 0.00749189080670476, 0.025575991719961166, 0.0008824110263958573, -0.005263331811875105, -0.007380463182926178, -0.01142464205622673, 0.00482417456805706, 0.011411532759666443, -0.0026513298507779837, -0.01190312672406435, -0.006... |
45 | LLY | 2016 | Certain of our Elanco animal health products are covered by patents or other forms of intellectual property protection. Historically, upon loss of effective market exclusivity for our animal health products, we have not generally experienced the rapid and severe declines in revenues that are common in the human pharmac... | [-0.003550937632098794, -0.0240072812885046, 0.010746434330940247, -0.038652390241622925, -0.00250103697180748, 0.010311762802302837, -0.0016124667599797249, -0.00206302129663527, -0.020449655130505562, 0.0006123026832938194, 0.006235874257981777, 0.01762763038277626, 0.004303255118429661, -0.0025344733148813248, -0.00... |
46 | LLY | 2016 | 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 a... | [-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.... |
47 | LLY | 2016 | 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... | [-0.008427286520600319, 0.02468857727944851, 0.015816330909729004, -0.044037625193595886, -0.007645233999937773, 0.02904379926621914, 0.005754150915890932, 0.0047529893927276134, 0.006522719282656908, -0.031524792313575745, 0.012081357650458813, 0.031389955431222916, -0.0022382871247828007, 0.008926181122660637, -0.012... |
48 | LLY | 2016 | The most relevant U.S. patent protection or data protection for our top-selling or recently launched patent-protected marketed products is as follows: | [-0.02251378819346428, -0.0018728284630924463, 0.014092701487243176, -0.034773509949445724, -0.0016154805198311806, 0.009078568778932095, -0.015460796654224396, 0.004217184614390135, -0.011927658692002296, -0.015115451999008656, 0.014610718004405499, 0.01611163839697838, -0.012824226170778275, -0.014039572328329086, -0... |
49 | LLY | 2016 | •Alimta is protected by a vitamin regimen patent (2021) plus pediatric exclusivity (2022). | [0.005305293947458267, -0.015605727210640907, -0.0030574819538742304, -0.03520756587386131, -0.014247571118175983, 0.032778557389974594, -0.012765353545546532, -0.01448263693600893, -0.022096142172813416, 0.0019898933824151754, 0.03243901580572128, 0.019523482769727707, 0.003979786764830351, -0.024041960015892982, -0.0... |
50 | LLY | 2016 | •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, 0.00... |
51 | LLY | 2016 | •Cyramza is protected by biologics data package protection (2026). | [-0.029293300583958626, -0.017690803855657578, -0.0030074366368353367, -0.02014748938381672, -0.002621910534799099, 0.024433337152004242, -0.027557598426938057, -0.0020644834730774164, -0.023111533373594284, 0.009452897123992443, 0.01528752502053976, 0.012056449428200722, 0.003765137167647481, -0.031189220026135445, -0... |
52 | LLY | 2016 | •Effient is protected by a compound patent (April 2017) plus pediatric exclusivity (October 2017) and patents covering methods of using Effient with aspirin (2023), although the method patents were held unpatentable in an inter partes review and we are appealing those decisions (for further information see Item 8, "Fin... | [-0.029771294444799423, 0.023061323910951614, 0.004578647669404745, -0.04246510937809944, 0.012478663586080074, 0.020331615582108498, 0.0032457299530506134, -0.01596139371395111, -0.013890581205487251, -0.021151872351765633, 0.022684812545776367, 0.024769071489572525, -0.00407775305211544, 0.00618218258023262, -0.01021... |
53 | LLY | 2016 | •Forteo is protected by patents primarily covering its formulation and related processes (December 2018) and use patents (August 2019). | [-0.015959512442350388, -0.005457726307213306, -0.013504202477633953, -0.03221259266138077, -0.0026588067412376404, 0.008947202004492283, -0.020496496930718422, 0.009994711726903915, -0.011649376712739468, 0.0002547884068917483, 0.02567399851977825, 0.010995516553521156, -0.00542102986946702, 0.005521110724657774, 0.01... |
54 | LLY | 2016 | •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.... |
55 | LLY | 2016 | •Lartruvo is protected by a compound patent (2027, not including possible patent extension) and by biologics data package protection (2028). | [-0.014573580585420132, -0.002460626419633627, 0.0030645225197076797, -0.012938723899424076, 0.002298808889463544, 0.01090349443256855, -0.0158948116004467, -0.01171091292053461, -0.026357894763350487, 0.0054717655293643475, 0.00566527945920825, 0.014093132689595222, -0.012805266305804253, -0.02015211246907711, 0.02495... |
56 | LLY | 2016 | •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, 0.01... |
57 | LLY | 2016 | •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, 0.01131... |
58 | LLY | 2016 | •Taltz is protected by a compound patent (2026 not including possible patent extension) and by biologic data package protection (2028). | [-0.01672382652759552, -0.00985770020633936, 0.022601546719670296, -0.023365912958979607, -0.004902492742985487, 0.028413372114300728, -0.027649004012346268, -0.01132713072001934, -0.012585700489580631, -0.0040228115394711494, -0.009785217233002186, 0.02320776879787445, 0.004362164065241814, -0.01457569096237421, 0.011... |
59 | LLY | 2016 | •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. | [-0.027211667969822884, -0.02487422153353691, 0.02503635548055172, -0.013382898643612862, 0.011423766613006592, 0.02032092772424221, -0.011241364292800426, -0.008809338323771954, -0.022766465321183205, -0.0043404907919466496, 0.005799706559628248, 0.02032092772424221, 0.002131400629878044, 0.001714240526780486, 0.00941... |
60 | LLY | 2016 | •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, 0.0151... |
61 | LLY | 2016 | 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, -0.00019... |
62 | LLY | 2016 | •Forteo in Japan (data package protection July 2018; patent covering its formulation and related process August 2019). | [-0.013816798105835915, -0.002446866361424327, -0.013605802319943905, -0.016294293105602264, -0.006578293163329363, 0.011509460397064686, -0.020500589162111282, 0.00773196155205369, 0.005594782065600157, 0.0005428027943708003, 0.019860796630382538, 0.019030427560210228, -0.0076434798538684845, -0.010127780959010124, 0.... |
63 | LLY | 2016 | Baricitinib (Olumiant), has been submitted for regulatory review in the U.S. and Japan and is protected by a compound patent in the U.S. and Japan until 2030 (not including possible patent extension) and 2029 (not including possible patent extension), respectively. Additional information about this molecule is provided... | [-0.006359572522342205, -0.01092094462364912, 0.009214958176016808, -0.024384399875998497, 0.013950880616903305, 0.03322390839457512, -0.016506565734744072, 0.0014565101591870189, -0.016809560358524323, 0.005644903052598238, 0.010822141543030739, -0.006231129635125399, 0.006112567149102688, -0.00947184395045042, -0.004... |
64 | LLY | 2016 | 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. Registrations... | [-0.00739061227068305, -0.01836765743792057, 0.014345729723572731, -0.0348140113055706, 0.0005071439663879573, 0.005257965996861458, -0.008870015852153301, 0.010067627765238285, 0.013820572756230831, -0.016254223883152008, -0.00830002874135971, 0.0232093408703804, -0.005209933500736952, -0.002723447047173977, -0.000224... |
65 | LLY | 2016 | Most of our major products are not subject to significant license agreements. 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. The ag... | [0.0022668112069368362, -0.001614473294466734, 0.019343456253409386, -0.036188382655382156, -0.006363862659782171, 0.021438997238874435, -0.01680462807416916, 0.003050959901884198, -0.026301726698875427, -0.0291763786226511, 0.01924942433834076, 0.03925109654664993, -0.00039837107760831714, 0.010820245370268822, 0.0101... |
66 | LLY | 2016 | In the U.S., the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, authorizes the FDA to approve generic versions of innovative human pharmaceuticals (other than biologics) without completion of safety and efficacy studies, i.e., a complete New Drug Application (NDA... | [-0.009164059534668922, -0.004733864683657885, -0.00034352572401985526, 0.0067077139392495155, -0.024347517639398575, 0.008840146474540234, -0.016830019652843475, -0.00840151309967041, -0.03079880028963089, -0.0064782751724123955, 0.01703246496617794, -0.0027532668318599463, 0.012140017934143543, 0.007780678104609251, ... |
67 | LLY | 2016 | 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 al... | [-0.007420182228088379, -0.012481541372835636, -0.009920533746480942, 0.006277837790548801, -0.019894983619451523, -0.0032164230942726135, -0.044858068227767944, -0.009313979186117649, -0.03693242371082306, 0.01275786105543375, 0.018452731892466545, 0.0146246999502182, -0.005647695157676935, 0.004808628465980291, 0.010... |
68 | LLY | 2016 | Generic manufacturers use Paragraph IV certifications extensively to challenge patents on innovative human pharmaceuticals. In addition, generic companies have shown willingness to launch “at risk,” i.e., after receiving ANDA approval but before final resolution of their patent challenge. We are currently in litigation... | [-0.0006325323483906686, -0.015509898774325848, -0.01579788140952587, -0.01930852048099041, -0.026110386475920677, 0.019623929634690285, -0.02050159126520157, 0.0021684374660253525, -0.021516384556889534, -0.021214690059423447, 0.02091299369931221, 0.015345337800681591, -0.0007970936130732298, -0.0014716233126819134, 0... |
69 | LLY | 2016 | In addition, there is a procedure in U.S. patent law known as inter partes review (IPR), which 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 ... | [-0.004247100092470646, -0.0017037391662597656, 0.0055918460711836815, -0.023435072973370552, -0.004980290774255991, 0.015772046521306038, -0.0012881518341600895, -0.015204415656626225, -0.005487104412168264, -0.010122762061655521, 0.01228516735136509, 0.002772271865978837, 0.004757292568683624, 0.00017981333076022565,... |
70 | LLY | 2016 | 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 administra... | [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.... |
71 | LLY | 2016 | 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. Pr... | [0.014626665972173214, -0.0027763578109443188, -0.01572333462536335, -0.025144124403595924, -0.008885666728019714, 0.019251175224781036, 0.003298266790807247, 0.02490629255771637, -0.025923684239387512, -0.004446136299520731, -0.011263986118137836, -0.013318589888513088, -0.020929213613271713, -0.007590803317725658, -0... |
72 | LLY | 2016 | 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 con... | [0.016136854887008667, -0.003614393062889576, -0.01987588219344616, -0.020138269290328026, -0.01840651035308838, 0.01099405251443386, -0.007661726325750351, 0.01932486705482006, -0.009892023168504238, 0.004893533885478973, 0.016018779948353767, -0.01571703515946865, -0.012542140670120716, 0.004568829201161861, -0.02505... |
73 | LLY | 2016 | 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 Ministr... | [0.02282380871474743, -0.006420019082725048, -0.012833456508815289, -0.024561261758208275, -0.010674803517758846, 0.022573720663785934, -0.0014635076513513923, 0.0246665608137846, -0.017664100974798203, -0.011411904357373714, -0.0005429539014585316, 0.00392901198938489, -0.01328098215162754, -0.011714641936123371, -0.0... |
74 | LLY | 2016 | 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 go... | [-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, ... |
75 | LLY | 2016 | 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... | [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, -0.0135... |
76 | LLY | 2016 | 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 Kingdo... | [-0.003870235290378332, -0.007100330200046301, 0.007649021688848734, -0.04243214800953865, -0.007296291645616293, 0.01537642814218998, -0.011182856746017933, 0.020131755620241165, -0.004624686203896999, -0.033104393631219864, 0.012678694911301136, 0.0009985860669985414, 0.02088947221636772, -0.0001565648999530822, -0.0... |
77 | LLY | 2016 | 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 p... | [-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... |
78 | LLY | 2016 | 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 co... | [-0.002072868635877967, 0.004640995059162378, -0.004627875983715057, -0.023496882990002632, -0.006556430831551552, 0.015074214898049831, -0.006454755086451769, -0.005772545468062162, -0.024533318355679512, 0.0066285873763263226, 0.021515849977731705, 0.03460903465747833, -0.013880347833037376, 0.0033815307542681694, -0... |
79 | LLY | 2016 | 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. These rebates are affected by the introduction of competitive products and generics ... | [0.009378975257277489, -0.014878346584737301, 0.0028427571523934603, -0.0283981803804636, -0.007223640102893114, 0.024531638249754906, 0.00044821182382293046, 0.010724427178502083, -0.028581056743860245, -0.007125670090317726, 0.009646759368479252, 0.02787567302584648, -0.0017650892259553075, -0.00667827483266592, -0.0... |
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