321:. Schlessinger testified in court that the idea of combining the anti-EGFR antibody that his lab had developed with chemotherapy in cancer treatment was his own idea. However, the Weizmann Institute scientists provided extensive documentation that they had been developing this idea using an antibody against EGFR that Schlessinger's laboratory had developed and generated, and that he had given them for these studies. Schlessinger claims to have initiated the idea of this use in combination therapy, but had not documented his research and ideas as thoroughly, leaving him forced to rely on his recollections of the events that led to the patent filing some 17 years before Yeda mounted their challenge.
213:(Waksal had dated Stewart's daughter) also became embroiled in the scandal after it emerged that she sold about $ 230,000 in ImClone shares on December 27, just a day before the announcement of FDA decision. Although Stewart maintained her innocence, she was found guilty and sentenced on July 16, 2004, to five months in prison, five months of home confinement, and two years probation for lying about a stock sale, conspiracy, and obstruction of justice.
199:
the general counsel, sold $ 2.5 million in shares on
December 6. Ronald A. Martell, the vice president for marketing and sales, sold $ 2.1 million in shares on December 11. Four other executives sold shares in the following weeks as well. Later, Samuel Waksal pleaded guilty to various charges, including
236:
The FDA's
February 2004 announcement of approval for use of Erbitux for treatment of colorectal cancer reported that conclusions were drawn from a trial involving 329 patients, of which 10.8% responded when Erbitux was used by itself, delaying tumor growth by 1.5 months. When used in conjunction with
228:
replied "My children know better than that, Mr. Landes." Further questioning about this and subsequent forgeries on Waksal's part revealed that neither Landes, the chief legal officer of the company, nor the company's outside directors reported Waksal's actions to proper authorities or made any moves
324:
The court ruled that Yeda are the sole owners of the disputed patent in the U.S., while Yeda and Sanofi-Aventis co-own the 866 Patent's foreign counterparts. Following the ruling, ImClone and Sanofi-Aventis agreed to settle the dispute with Yeda, for $ 120 million, with each company paying Yeda $ 60
255:
reported that "Bristol-Myers Squibb Co. and ImClone
Systems Inc. said their cancer drug, Erbitux, failed to significantly prolong the lives of people with pancreatic cancer in a new study, marking yet another setback in the drug industry's efforts to find a better treatment for this deadly disease."
223:
A Congressional hearing on improprieties at ImClone, held in
October 2002, unveiled a culture of corruption dating back to 1986. This was the year that ImClone CEO Waksal first forged the signature of the company's general counsel John Landes (one of the three original employees of the company) for
340:
On
September 10, 2008, an undisclosed company and CEO offered to take over ImClone for $ 70 a share, financing approach was not disclosed. The offer was conditional on the results of a due diligence review of ImClone's business and technology by the undisclosed party, to be completed September 28,
198:
charges for informing friends and family to sell their stock, and attempting to sell his own. His daughter, Aliza Waksal, sold $ 2.5 million in shares on
December 27. His father, Jack Waksal, sold $ 8.1 million in shares over the 27th and 28th. Company executives had done the same. John B. Landes,
352:
On
October 6, 2008, ImClone agreed to be acquired by Eli Lilly for $ 6.5 billion ($ 70/share). On November 24, 2008, ImClone was formally acquired by Eli Lilly, with all NASDAQ IMCL shares tendered for $ 6.5 billion ($ 70/share). ImClone is now a fully owned subsidiary of
229:
to have Waksal removed as CEO. Instead, testimony revealed that they initiated their own internal investigation, which was never concluded. The decades-long tolerance for Waksal's fraud, starting from the company's earliest days, provoked
Representative
247:
In
January 2006, the company was put up for sale but failed to find any buyers, likely due to the fact that Erbitux by that time faced significant competition in the medical marketplace. ImClone directors withdrew the sale of the company in mid-2006.
272:
of the drug. One ultimately succeeded; the other failed despite repeated pleas to ImClone officials. It was alleged in the story that ImClone was arbitrary in who received the drug and had no written criteria for compassionate use.
285:
acquired a majority of stock thereby giving him control of the board. Within hours of the announcement, interim CEO Joseph
Fischer resigned, and Icahn announced that other members of the Board of Directors would not be re-elected.
348:
upped its offer to take over ImClone to $ 62 a share. In addition, Bristol threatened to take the offer to the share holders for a proxy battle with the intention of replacing the current Board of Directors headed by Carl Icahn.
224:
financial gain. Nonetheless, Landes defended Waksal's illegal actions at the hearings before the Subcommittee on Oversight and Investigations, portraying the forgery as "a good-faith misunderstanding," to which Representative
1192:
268:, on February 12, 2004. In May 2001, while ImClone was still seeking approval for the drug (then known as IMC-C225), the CBS news program "60 Minutes" aired a story about two cancer patients' struggles to obtain
491:"Statement by Robert Temple, M.D., Associate Director for Center for Drug Evaluation and Research, Food and Drug Administration Before the Committee on Government Reform, U.S. House of Representatives"
741:
Aboud-Pirak E, Hurwitz E, Pirak ME, Bellot F, Schlessinger J, Sela M (Dec 21, 1988). "Efficacy of antibodies to epidermal growth factor receptor against KB carcinoma in vitro and in nude mice".
1185:
2004:
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2009:
1201:
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1984:
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1969:
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244:
committed $ 2 billion (including a $ 1 billion up-front cash payment) for less than 20% of ImClone due to what was called at the time the drug's "blockbuster" potential.
1994:
325:
million. In return, ImClone were also granted a worldwide license to technology covered by the 866 Patent, and agreed to pay a small royalty on Erbitux sales to Yeda.
398:
317:, claimed to have come up with this concept alongside Schlessinger when they worked together there years earlier, and Yeda challenged the Aventis patent in the
1989:
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antibodies in combination with chemotherapy, to slow the growth of certain tumors. This is the so-called '866' patent, which was filed in 1989 by
184:
220:("German Merck," not to be confused with the US company of similar name) resulted in an FDA approval of Erbitux in 2004 for use in colon cancer.
2014:
829:
776:
574:
990:
686:"US Patent #6,217,866 : Monoclonal antibodies specific to human epidermal growth factor receptor and therapeutic methods employing same"
337:
offered to take over ImClone for $ 60 a share cash. The offer was made by letter addressed to ImClone's chairman of the board, Carl Icahn.
541:
237:
a standard chemotherapy treatment, irinotecan, 22.9% of patients responded and tumor growth was delayed by approximately 4.1 months.
490:
145:, and became a fully-owned subsidiary of Eli Lilly and Company on November 24, 2008. Prior to the acquisition, it was traded on the
1948:
303:
61:
56:
210:
1098:
ImClone Systems Incorporated Announces Decision by The FDA Not To Accept For Filing The ERBITUX Biologics License Application.
807:
1979:
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that numerous executives sold their stock before the announcement of the decision after the close of trading on December 28.
929:
1355:
1058:"Lilly's CYRAMZA™ (ramucirumab) Becomes First FDA-Approved Treatment for Advanced Gastric Cancer After Prior Chemotherapy"
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708: "Monoclonal antibodies specific to human epidermal growth factor receptor and therapeutic methods employing same."
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153:. Imclone lost its separate identity in 2014 when its former ImClone research and manufacturing sites were renamed
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1094:, "U.S. House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations", June 13, 2002
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Yeda Research and Development, a company set up to commercialize and market the products of research at the
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361:, was approved by the FDA for gastric cancer. Lilly acquired the drug through its purchase of ImClone.
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Deep Value: Why Activist Investors and Other Contrarians Battle for Control of Losing Corporations
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Joseph Schlessinger's former colleagues at the Weizmann Institute, in particular
203:, and on June 10, 2003, was sentenced to seven years and three months in prison.
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Ultimately a new clinical trial and FDA filing prepared by Imclone's partner
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Takeover offer from Bristol-Myers Squibb, and subsequent bidding showdown
141:. On October 6, 2008, it accepted a $ 6.5 billion acquisition offer from
130:
830:"ImClone and Sanofi-Aventis Settle Patent Litigation with Yeda Researc…"
1906:
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ImClone's stock price dropped sharply at the end of 2001 when its drug
1911:
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1462:
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459:"Dr. John Mendelsohn, 82, Researcher Who Led Top Cancer Center, Dies"
146:
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357:. In 2014 a drug developed by ImClone, tumor angiogenesis inhibitor
1926:
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546:
493:. U.S. Food and Drug Administration. June 20, 2001. Archived from
129:
company dedicated to developing biologic medicines in the area of
640:"ImClone seeking new CEO with biotech experience - Oct. 25, 2006"
1706:
1174:
133:. It was founded in 1984 and had its corporate headquarters in
298:
in Israel, challenged the Aventis-owned patent, licensed by
264:
The FDA approved the aforementioned colorectal cancer drug,
1008:"Eli Lilly Agrees to Buy ImClone Systems for $ 6.5 Billion"
608:"Eli Lilly Agrees to Buy ImClone Systems for $ 6.5 Billion"
663:
281:
On October 25, 2006, a group led by billionaire investor
863:"Bristol-Myers offers $ 4.5 billion to buy out ImClone"
1138:
ImClone Founder Waksal Sentenced to 7 Years in Prison
1128:
ImClone Founder Pleads Guilty to Avoiding Sales Taxes
930:"Icahn says he has $ 70-per-share offer for Imclone"
542:"Dying Patients Find Experimental Drugs Hard to Get"
1699:
1590:
1583:
1208:
110:
98:
88:
70:
49:
34:
24:
405:. Bloomberg Businessweek. Snapshot. Archived from
2005:Pharmaceutical companies disestablished in 2014
1148:'I will be back,' Stewart vows after sentencing
233:to refer to the ongoing misconduct as "wacky."
2010:Biotechnology companies disestablished in 2014
1092:An Inquiry into the ImClone Cancer-Drug Story.
777:"Court ruling on Yeda vs Aventis/Imclone case"
1202:Pharmaceutical companies of the United States
1186:
183:(FDA) approval. It was later revealed by the
8:
1985:Pharmaceutical companies established in 1984
1975:Pharmaceutical companies based in New Jersey
1970:Biotechnology companies of the United States
19:
2000:Biotechnology companies established in 1984
1587:
1193:
1179:
1171:
1165:FDA Approves Erbitux for Colorectal Cancer
575:"For some, untested drug is a last chance"
18:
1040:"FDA approves Cyramza for stomach cancer"
1118:A Closer Look at Martha Stewart's Trades
1062:Eli Lilly and Company Investor Relations
724:"ImClone goes up against patent dispute"
1995:Companies formerly listed on the Nasdaq
434:. Eli Lilly and Company. Archived from
387:
185:U.S. Securities and Exchange Commission
985:. John Wiley & Sons. p. 173.
718:
716:
714:
892:
890:
856:
854:
808:"ImClone settles drug patent dispute"
7:
1046:. U.S. Food and Drug Administration.
573:Foreman, Judy (September 23, 2003).
393:
391:
290:Yeda/Aventis/Imclone patent dispute
137:, and its research headquarters in
1480:Pharmaceutical Product Development
979:Carlisle, Tobias E. (2014-08-18).
955:"Bristol-Myers Boosts Imclone Bid"
898:"ImClone gets second takeover bid"
14:
1990:1984 establishments in New Jersey
509:"Controversial Compassionate Use"
1949:List of pharmaceutical companies
304:Epidermal growth factor receptor
149:stock exchange under the symbol
587:from the original on 2012-10-05
554:from the original on 2013-12-26
521:from the original on 2013-12-26
211:Martha Stewart Living Omnimedia
1006:Pollack, Andrew (2008-10-06).
861:Saul, Stephanie (2008-07-31).
606:Pollack, Andrew (2008-10-06).
540:Levine, Jeff (June 20, 2001).
1:
2015:2008 mergers and acquisitions
1356:Institute for OneWorld Health
1108:ImClone Stock Sales Disclosed
814:. 11 Dec 2007. Archived from
399:"ImClone Systems Corporation"
296:Weizmann Institute of Science
260:Compassionate use controversy
179:, failed to get the expected
1575:West Pharmaceutical Services
836:. 2012-07-09. Archived from
664:"Technology Transfer Israel"
457:Thomas, Katie (2019-01-18).
181:Food and Drug Administration
76:; 40 years ago
2031:
1381:McNeil Consumer Healthcare
194:, was arrested in 2002 on
167:ImClone stock trading case
164:
1944:
1887:Smith, Kline & French
1438:Northwest Biotherapeutics
1423:Merrimack Pharmaceuticals
16:Biopharmaceutical company
428:"Eli Lilly US Locations"
1142:San Francisco Chronicle
1064:. Eli Lilly and Company
755:10.1093/jnci/80.20.1605
344:On September 23, 2008,
253:The Wall Street Journal
161:Insider trading scandal
135:Bridgewater, New Jersey
62:Pharmaceutical industry
1812:Leiner Health Products
1256:Amneal Pharmaceuticals
544:. WebMD News Archive.
403:Company Insight Center
302:, for the use of anti-
277:Carl Icahn acquisition
1980:Eli Lilly and Company
1366:Johnson & Johnson
355:Eli Lilly and Company
155:Eli Lilly and Company
143:Eli Lilly and Company
105:Eli Lilly and Company
57:Biotechnology company
1660:Jazz Pharmaceuticals
1650:Horizon Therapeutics
1520:Sarepta Therapeutics
1495:Proteon Therapeutics
1490:Procter & Gamble
1403:Melinta Therapeutics
1296:Bristol Myers Squibb
517:. CBS. May 3, 2001.
346:Bristol-Myers Squibb
335:Bristol-Myers Squibb
242:Bristol-Myers Squibb
1867:Repros Therapeutics
1782:Forest Laboratories
1767:Cutter Laboratories
1485:Prasco Laboratories
1226:Acorda Therapeutics
1216:Abbott Laboratories
1167:, February 12, 2004
1104:, December 28, 2001
961:. 23 September 2008
497:on August 20, 2001.
371:Accounting scandals
308:Rhone-Poulenc-Rorer
270:"compassionate use"
240:In September 2001,
177:monoclonal antibody
123:ImClone Systems LLC
90:Number of employees
21:
1827:Miles Laboratories
1817:Martek Biosciences
1640:Endo International
1560:Ventria Bioscience
1326:Danco Laboratories
1132:The New York Times
1122:The New York Times
1112:The New York Times
1012:The New York Times
959:The New York Times
902:The New York Times
867:The New York Times
743:J Natl Cancer Inst
612:The New York Times
463:The New York Times
438:on 20 October 2018
333:On July 31, 2008,
175:, an experimental
1957:
1956:
1940:
1939:
1772:DNAPrint Genomics
1261:Avax Technologies
992:978-1-118-74796-4
432:R&D Locations
209:, the founder of
127:biopharmaceutical
120:
119:
2022:
1588:
1535:Tec Laboratories
1408:Melior Discovery
1393:Kinetic Concepts
1336:Galena Biopharma
1195:
1188:
1181:
1172:
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1069:
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1047:
1044:FDA NEWS RELEASE
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834:Business Library
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782:. Archived from
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201:securities fraud
192:Samuel D. Waksal
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1792:ImClone Systems
1695:
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1428:Myriad Genetics
1418:Merck & Co.
1376:Janssen Biotech
1346:Gilead Sciences
1204:
1199:
1154:, July 17, 2004
1144:, June 10, 2003
1134:, March 3, 2003
1124:, July 15, 2002
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251:In April 2007,
226:James Greenwood
196:insider trading
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115:www.imclone.com
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1692:(Canada, 2010)
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904:. 2008-09-10.
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840:on 9 July 2012
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812:The Scientist
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789:on 2011-09-27
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644:money.cnn.com
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409:on 2009-05-18
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231:Peter Deutsch
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190:Its founder,
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1670:Mallinckrodt
1555:Upsher-Smith
1386:Ortho-McNeil
1151:
1141:
1131:
1121:
1111:
1102:BusinessWire
1101:
1066:. Retrieved
1061:
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1023:. Retrieved
1011:
1001:
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963:. Retrieved
958:
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938:. Retrieved
936:. 2008-09-10
933:
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901:
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866:
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838:the original
833:
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784:the original
771:
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670:December 25,
668:. Retrieved
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643:
634:
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589:. Retrieved
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545:
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512:
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436:the original
431:
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407:the original
402:
351:
343:
339:
332:
323:
315:Michael Sela
312:
293:
280:
263:
250:
246:
239:
235:
222:
215:
205:
189:
170:
154:
150:
122:
121:
25:Company type
1862:Parke-Davis
1545:Trevena Inc
1413:Mentholatum
1221:AbbVie Inc.
1068:14 November
45:: IMCL
20:ImClone LLC
1964:Categories
1922:ViroPharma
1822:Massengill
1550:Ultragenyx
1281:Bioverativ
1025:2020-02-21
965:2020-05-13
940:2020-05-13
915:2020-05-13
880:2020-05-13
844:2020-05-13
793:2009-09-23
700:US 6217866
649:2020-04-09
625:2020-04-09
514:60 Minutes
476:2019-11-21
442:19 October
413:2013-12-25
382:References
283:Carl Icahn
218:Merck KGaA
29:Subsidiary
1872:Qualitest
1742:CancerVax
1525:Sheffield
1515:RespireRx
1510:Regeneron
1361:Intercept
1341:Genentech
1331:Eli Lilly
1316:CytoSport
1306:Ceragenix
1020:0362-4331
910:0362-4331
875:0362-4331
728:USA Today
666:. YEDARND
620:0362-4331
471:0362-4331
37:Traded as
1752:CoTherix
1747:Cephalon
1630:Covidien
1620:Allergan
1610:Alkermes
1530:Spectrum
1398:McKesson
1291:Biovista
1271:BioCryst
1086:Articles
585:Archived
552:Archived
519:Archived
365:See also
131:oncology
50:Industry
1907:Trubion
1757:Covance
1737:Bradley
1686:, 2013)
1684:Ireland
1680:Perrigo
1676:, 2013)
1674:Ireland
1666:, 2012)
1664:Ireland
1656:, 2014)
1654:Ireland
1646:, 2014)
1644:Ireland
1636:, 2007)
1634:Ireland
1626:, 2015)
1624:Ireland
1616:, 2011)
1614:Ireland
1606:, 2013)
1604:Ireland
1600:Actavis
1570:Viatris
1468:Hospira
1458:Ovation
1453:Organon
1448:NovaBay
1433:Moderna
1371:Ethicon
1301:Century
1286:Biovest
1246:Alnylam
1241:Alexion
1231:Advaxis
1209:Current
763:3193478
359:Cyramza
300:Imclone
266:Erbitux
173:Erbitux
111:Website
79: (
71:Founded
1932:Zonite
1912:Upjohn
1847:Nuvelo
1842:Nereus
1837:Naurex
1762:Cubist
1732:Biolex
1717:Amylin
1584:Former
1565:Vertex
1473:Searle
1463:Pfizer
1276:Biogen
1266:Baxter
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341:2008.
147:NASDAQ
125:was a
100:Parent
43:Nasdaq
1927:Wyeth
1917:Verus
1897:Tanox
1877:Rib-X
1852:Ortho
1832:Mylan
1787:Genta
1722:ARIAD
1700:Other
1540:Titan
1505:Quark
1351:Ionis
1321:CytRx
1311:Combe
1251:Amgen
1236:Alcon
787:(PDF)
780:(PDF)
547:WebMD
94:1,128
1802:King
1797:ISTA
1777:Epix
1727:Barr
1707:Alza
1070:2014
1016:ISSN
987:ISBN
906:ISSN
871:ISSN
759:PMID
672:2013
616:ISSN
593:2013
560:2013
527:2013
467:ISSN
444:2018
151:IMCL
81:1984
74:1984
1902:TAP
1857:OSI
1159:FDA
751:doi
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