john w kosolcharoen liveyon

In recent years, though, her mothers pain had come to preoccupy her. The closest hospital was in the town of Sweeny. If anyone else knew whats going on in this industry, they would roll over in their grave.. CASE MANAGEMENT CONFERENCE SCHEDULED FOR 11/19/2012 AT 09:00:00 AM IN C12 AT CENTRAL JUSTICE CENTER. 9 0 obj In addition, you failed to use FORM-LL-037 to formally initiate and document your investigation. 3. By the nature of their routes of administration, your products purport to be sterile and are expected to be sterile. Celltex has continued to align itself with the states elite, treating legendary former Texas A&M football coach Jackie Sherrill and former Dallas Cowboys superstar Tony Dorsett. Yet she knew that some readers might seek treatment and wouldnt be inclined to fly to Arizona, so she noted that stem cell injections were offered by a clinic in Missouri City, just southwest of Houston. Most of the injections are administered in his office by his nurse practitioner, he says, but for shots into the spinal column, he has partnered with the pain specialist that Dilley and her mother saw in Houston. For example: a. Liveyon Labs failed to adequately validate the aseptic process used to manufacture your PURE and PURE PRO products since operations began in January 2019. But before charging his patients $1,800 a vial for something that wasnt effective, he said, he decided to try it himself on a painful knee. 2019-08-23. Nonetheless, an information packet from one Liveyon-associated clinic includes a dosing chart with recommended numbers of cells for knee injections, erectile dysfunction, autism, neuropathy, and a host of other conditions. xY[s~W]R&fOR ? Virsh Edit Failed To Get Domain, Police News Stornoway, Jennette Mccurdy Podcast Dan Schneider, John W Kosolcharoen Liveyon, Prattmwp Portfolio Requirements, What Were The Lasting Effects Of The Crusades Quizlet, Stewart Funeral Home Oakland, Md, Tony Johnson Obituary Clovis Nm, California Floristic Province Climate, Fiat To Crypto Payment Gateway, This week, CDC officials said they confirmed a 13th case of infection. The most recent email I sent to Kosolcharoen some months back did not receive a reply. Hardy was based in Thailand, but he agreed to help remotely as Genetechs director of compliance. 264] and the regulations in 21 CFR Part 1271. PAYMENT RECEIVED BY FOR 195 - ANSWER OR OTHER 1ST PAPER, 195 - ANSWER OR OTHER 1ST PAPER, 210 - COURT REPORTING SERVICES IN CIVIL PROCEEDINGS LASTING UNDER 1 HOUR IN THE AMOUNT OF 900.00, TRANSACTION NUMBER 11203758 AND RECEIPT NUMBER 11027650. ORDER TO SHOW CAUSE RE: DISMISSAL SCHEDULED FOR 03/04/2013 AT 10:00:00 AM IN C12 AT CENTRAL JUSTICE CENTER. 262(a)]. Liveyon is a company that used to distribute an umbilical cord blood product manufactured by Genetech (not to be confused with the pharma company called Genentech). The stem cells had worked, almost miraculously, it seemed to Crawford, so she wrote a column about them. b. Liveyon Labs failed to thoroughly investigate five in-process BSC settling plates failures. JOHN W. KOSOLCHAROEN Manager 7700 Irvine Center Dr Ste 800 Irvine, CA 92618 Reviews Write Review There are no reviews yet for this company. d. Liveyon Labs used a non-sterile (b)(4) and the associated non-sterile (b)(4) to manufacture approximately (b)(4) batches of your products between January 16, 2019 and May 20, 2019, raising the potential for microbiological contamination. Your response also does not address your continued failure to have an IND in effect to study your products, nor your lack of an approved BLA to lawfully market your products. Listen to author Laura Beils hit Wondery podcast. The pain was excruciating. MINUTES FINALIZED FOR EX PARTE 08/02/2019 08:30:00 AM. This is a BETA experience. The manufacturer of the products for Liveyon, a company named Genetech (not the much larger and better-known Genentech), was hit with a November 28, 2018 FDA Warning Letter (cc to Liveyon) for having neither an investigational new drug application (IND) nor an approved biologics license application (BLA). Sponsored. And beyond all the science and the explanations, theres the story of the man behind it all. . Approve of CEO John W. Kosolcharoen 4 Ratings Your trust is our top concern, so companies can't alter or remove reviews. Mark Holzer, 49, of Huntington Beach, charged earlier this month with making a fraudulent claim that he was disabled and unable to perform his job at the U.S. Genetech closed shortly thereafter. Patrick Fortner, the executive director of the Texas Board of Chiropractic Examiners, told me that while investigations are ongoing, so far the board has not found instances of chiropractors either administering stem cells or ordering others to administer them. They learned that a few others were also from Brazoria County and had read about stem cells in Conversations With Gin. Theyd come seeking relief from neck pain, back pain, and arthritis. Among them is John Herzog, 63, an osteopathic physician in Falmouth, Maine, whose case was not among the 12 investigated by the CDC. State and federal investigators sought to figure out where the contamination had come from, combing through records, sending leftover product for lab testing, and interviewing medical personnel. H-E-Bs True Texas BBQ Restaurant Is Slipping. Kosolcharoen attributes his arrest to aggressive prosecutors who leaned on unduly complicated military insurance rules and solicited the testimony of a former girlfriend. Nor did you commit to providing any follow-up response(s) to address any corrective actions once implemented. Liveyon spent a million dollars on a commercial seminar for doctors who were pitched on how much money they could make and then given a script of exactly what to say to patients. How Florence ButtNot Her SonLaunched the H-E-B Empire, Jimmy Carters Peanut-and-Egg Taco Made Quite the Impression on San Antonians, The Top 50 Texas BBQ Joints: 2021 Edition. Such licenses are issued only after showing that the product is safe, pure, and potent. At a Wondery listening party Q and A for Bad Batch, Laura told me that to tell a big story like this narratively You have to pick out the details that matter most, but leave in enough to tell the story. After decades of research, scientists are still optimistic that cellular therapy might one day treat a host of diseases. Hardy figured that the entire company would probably implode before it even got off the ground. Awed by stem cells apparent effectiveness, he decided to get into the business. John K. is a quintessentially American figure, a smooth talker who got in over his head Liveyon and he comes across as a very sympathetic character which makes him hard to hate. Theres An App for That. SILVER SPRING, Md., Dec. 6, 2019 /PRNewswire/ The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and from PR Newswire: via IFTTT The two people who ran the scheme pleaded guilty to wire fraud and were sent to federal prison. endobj Those who commit fraud targeting health care funding get rich on the backs of American taxpayers who watch their premiums go up, Deirdre Fike, assistant director in charge of the FBIs Los Angeles field office, said in a statement. All complaints are forwarded directly to the Chief Compliance Officer (CCO) of Liveyon LLC/Liveyon Labs for logging into the Liveyon LLC complaint system prior to routing to Liveyon Labs QA for logging into the Liveyon Labs complaint system, which initiates the investigation. The media fill batch sizes used for your validation study LL-VAL-004, entitled Validation of Aseptic Processing of the PURE Product, did not represent the maximum commercial batch size. I only want high-quality, reputable physicians that are doing good work providing these types of services to the people of Texas, he says. iv. For further information about IND requirements for biological products, contact the Center for Biologics Evaluation and Research (CBER), Division of Regulatory Project Management, Office of Tissues and Advanced Therapies, at (240) 402-8190, or Liveyon was preying on people for whom the promise of a miracle cure from stem cells was their last hope for a better life and they were happy to pay whatever it took. x+r 34-73378; File No. In interviews with The Post, Kosolcharoen, 47, defended his company and its treatments. Hed been urging doctors to prescribe made-to-order pain creams to active and former members of the military at an average cost of $14,000 apiece. endobj Laura Beilis a science journalist based in Dallas. Dr. Samuel Albert, 81, of Laguna Beach, a psychiatrist who operated an office in Fountain Valley, charged on Tuesday with conspiring to commit health care fraud. The number of colonies were not counted if greater than 1 and marked as 1+. Kosolcharoen said he started Liveyon in 2016, after years of working as an entrepreneur in the insurance, real estate and telemedicine industries. Compounding pharmacies formulate personalized medicines, but prosecutors said those involved prepared formulas aimed at the highest possible profit, not maximum effectiveness. Dilley and the medics had to haul her mother outside in a bedsheet. Opinions expressed by Forbes Contributors are their own. A cursory Google search turns up video testimonials promoting stem cell treatments for everything from baldness to Lyme disease to autism. b. English (7 reviews) Other English (7 reviews) 5.0 Current Employee, less than 1 year Great Nov 26, 2021 - Sales Associate Recommend CEO Approval Business Outlook Doctors allegedly were paid kickbacks for prescribing medications with reimbursements of up to $15,000. Williamson was rushed in by ambulance from Lake Jackson. E-FILING TRANSACTION 2802650 RECEIVED ON 06/06/2019 01:57:33 PM. Therefore, your products are drugs as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. Liveyons tax returns reveal that the company brought in more than $6million in sales in 2017, its first full year of operation. After a series of tests and scans, doctors discovered the source of the problem: all were suffering from life-threatening bacterial infections. <>stream State representative Tan Parker, who sponsored the law that expanded access to unproven therapies in Texas, says he wants stem cells to be administered safely while also giving ill patients the freedom to try something experimental. You should take prompt action to correct these violations. By Saturday night, she was sweating heavily, vomiting, and babbling incoherently about her late husband. Gaveck has had no formal training in stem cells, but he said he has spent the past nine years immersed in the industry. For example: a. He visited a Beverly Hills clinic for stem cell treatment, and within weeks his pain subsided. E-FILING TRANSACTION 2812597 RECEIVED ON 07/05/2019 09:54:31 AM. (Generally speaking, the FDA has stipulated that human tissue can be used in patients so long as it is minimally manipulateda skin graft, for instanceand is intended for homologous use, meaning the extracted tissue serves the same function in the patients body as it would in the donors body.) But as for cleaning my house, that would be a chore. She doesnt remember anything about her acute infection, except for a vague recollection of the roar of helicopter blades. A doctor was in the room with Dilley and her mother when she read the text. FDA has found additional significant deviations upon further review of the information collected during the May 2019 inspection, as discussed below. ii. The patient sued Gaveck for malpractice, he said; he later decided not to renew his medical license. The site is secure. That's where he met Lois. Its the FDA that stands between us and all of that fraud. Or at least thats what its supposed to do. The CDC report revealed a specific risk: bacterial infection. Whats Up With All the Kangaroos on the Loose in Texas? Hormone replacement therapy was given to millions of women, until studies showed that doing so entailed more risks than had been previously understood. But he has an explanation for why they were in such a hurry to get started. High doses of vitamin E were once thought to prevent cancer, until a large study for prostate cancer found that the supplement actually increased the risk of malignancy. One of the companies is still active while the remaining five are now listed as inactive. Barbara Lotz|charlie Lotz vs Eileen Pinos|james Alan Sielski|compass MEDICAL Center P L L C|randall Brett Crockett|john W Kosolcharoen|alan Gaveck|lanny CROCKETT|JUSTIN Woodside|genetech INC|LOREEN Crockett|liveyon L L C|edwin N Pinos: More: Arizona: 2019-02-21: Jason Parks vs Racer Engineering|dale Dondel|denise Dondel: More: Arizona: 2019-02-21 The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. The study utilized (b)(4) vials per batch, however batches were observed to be manufactured with up to (b)(4) vials. Franchise Tax Board Suspension. After Gin Crawford mentioned his clinic in her column and he bought the ad in the Brazosport Facts, more patients began driving up from Brazoria County. <> TRICARE paid hundreds of millions of dollars for creams for minor pain, scars, erectile dysfunction or general wellness, prosecutors said. John Kosolcharoen has been associated with six companies, according to public records. 2020-04-14, San Diego County Superior Courts | Personal Injury | John W. Kosolcharoen, or John Kosolcharoen, has been involved in companies like: Liveyon LLC&amp;#x20AC; Finanstra&amp;#x20AC; Premier Funding USA (PFUSA) John is currently the Chief . Last March, the medical boards executive director sent a letter to the Texas Board of Chiropractic Examiners, emphasizing that the law requires stem cells to be administered by a physician. That customer was Liveyon. When you read about it every day, she says, it gives you hope., Crawford cautioned her readers to do their own research. We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations and prevent their recurrence. Before that, Kosolcharoen ran into trouble with the Securities and Exchange Commission. The agency is also seeking an injunction against a chain of stem cell clinics based in Rancho Mirage, California. At first, we were looking at, Was it possibly the procedure? Can College Sports Get More Absurd Than SMU Joining the Pac-12? She screamed bloody murder the whole time we were moving her, Dilley says. Forrest Wilder writes about politics and the outdoors. To launch the company, he brought on Alan Gaveck, 59, a podiatrist who serves as Liveyons top medical expert. The clinic, Texas Regional Health and Wellness, later bought ads in the Brazosport Facts that highlighted Crawfords mention of the clinic in her column. Learn More D&B Reports Available for Liveyon LLC. endobj And even when things go right, they may have gone wrong at first. 26S075SIr She wondered if there were others at the same hospital. In a test of nine products none of them from Liveyon Fortier found that none contained stem cells, or a single live cell of any kind. When she first brought her mother to Missouri City, Dilley didnt realize that Texas Regional Health and Wellness was owned and operated by a chiropractor rather than a licensed medical doctor. <>>>/Type/XObject/Subtype/Form/BBox[0 0 612 792]/Matrix[1 0 0 1 0 0]/FormType 1>>stream }B`'/_NpS/&ZcXb>w?922z>o_sWU|#cz. 22667 Old Canal Road x+r Liveyon has denied their claims and is fighting them in court. Liveyon also recently opened its own clinic in Cancun, Mexico, Kosolcharoen said, so that American patients can receive its treatments unfettered by FDA regulations. Many researchers believe in the potential of stem cells to treat a host of diseases. ORDER FOR WRIT OF POSSESSION RECEIVED ON 08/01/2019. LIVEYON IRVINE LLC Company Number 201814210847 Status Suspended Sos Incorporation Date 14 May 2018 (over 4 years ago . Their leader John Kosolcharoen? endstream JOHN W KOSOLCHAROEN VS. WELLS FARGO BANK, N.A. Ive been writing about medicine for 25 years, Laura says, and the placebo effect is powerful. Everyone else in the waiting room, she recalls, started to discuss all the wonderful things they had heard about stem cells. I thought they would have gotten caught sooner, he tells me. When Herzog expressed concerns about the products safety, a Liveyon sales person arranged a phone call with Gaveck, the companys top medical expert. John Kosolcharoen was 14 when he came to the United States from Thailand. He and Gaveck said the company recently set up its own laboratory, so it wont have to rely on outside manufacturers. Then, of course, I knew it was Genetech, and I said, Oh, crap. He was surprised not that something disastrous had happened but that Genetech had moved forward at all. AS SUCCESSOR BY MERGER TO WELLS FARGO HOME MORTGAGE, INC. ON 11/20/2012. Additionally, during the inspection, FDA investigators documented evidence of significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP), including deviations from section 501(a)(2)(B) of the FD&C Act and 21 CFR Parts 210, 211, and 1271. 262(a)(3); 21 CFR Part 312]. In 2015 alone, the pharmacy billed the government, through Tricare, an insurance program for the military, for almost $14million in pain creams. Over the past two years, Kosolcharoen said the company has sold 25,000 vials at $1,500 for a single-injection dose or $1,800 for a multiple-injection dose. Defendant John Kosolcharoen is directed to appear for Preliminary Hearing on 7/12/16 at 4:30 PM and for Post Indictment Arraignment on 7/18/16 at 10:00 AM before the Duty Magistrate Judge. Throughout the hour-and-a-half-long presentation, the doctor, Darrel Pierce, and the Liveyon sales rep, Tim Martin, promoted the healing powers of stem cells. And it just kept getting worse.. x+r AS SUCCESSOR BY MERGER TO WELLS FARGO HOME MORTGAGE, INC.; HSBC BANK USA, NATIONAL ASSOCIATION, AS TRUSTEE FOR WELLS FARGO HOME EWUITY TRUST 2004-2 ON 08/13/2012, DEMURRER FILED BY WELLS FARGO BANK, N.A. As noted above and in the FDA Warning Letter issued on November 29, 2018, to your former contract manufacturer Genetech, Inc. with a copy to Liveyon LLC and Mr. Kosolcharoen, to lawfully market a drug that is a biological product, a valid biologics license must be in effect [42 U.S.C. Whether youre a lifelong resident of D.C. or you just moved here, weve got you covered. Unfortunately, theres evidence that 90 percent of drugs that go into clinical trials dont work and the general public is often misled by slick advertising that often uses exaggerated or misleading claims. He just looked at me, she says. Sincerely, According to a complaint by the U.S. Attorneys Office, Kosolcharoen was encouraging service members to seek prescriptions, receiving commissions from the compounding pharmacy that made the cream, and recruiting others to find him more patients. Some of the most serious forms of human disease arise when cells and tissues in the body wither and diewhether they be cartilage in joints, neurons in the brain, or overworked heart muscle. It was almost dinnertime when Dilley and her mother began the hour-plus drive back to Brazoria County. The FDA has responded only to written questions for this story. I certainly didnt know anything about umbilical cord blood stem cells, he says. The Future of Regenerative Medicine | Liveyon LLC is the exclusive worldwide distributor of a regenerative medicine product that is derived from umbilical cord blood manufactured by Liveyon Labs. But mostly he worries about the patients themselves. Lisa Fortier, a Cornell University regenerative medicine researcher, said such products may not even contain stem cells. Many leading researchers compare the products being sold now to snake oil, saying there is little oversight, little scientific rationale for the procedures and little proof they have any effect. The umbilical cord products are not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Whatever testing on other products may show, tests paid for by Liveyon have indicated that its vials contain live cells and stem cells, according to a self-published company report. 26S075SIr The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah. Patients are offered a miracle cure, but instead they end up rushed to the hospital in critical condition. Yet even as scientists touted the medical potential of stem cells, antiabortion groups opposed the use of embryos, and in 2001 President George W. Bush banned federal funding for the creation of new cell linesthose not already in laboratories for research. And another column. *T0T0 Bf @ On a Wednesday afternoon in September 2018, Dilley and her mother arrived at the Houston clinic and, while in the waiting room, chatted with the other patients. Then, in late 2017, Dilley happened to read a column in her local newspaper, the Brazosport Facts, about stem cellscells that have the potential to serve as a repair system for injured or diseased tissue. Dorothy OConnell, now ninety, still lives by herself. 2017-09-01, Los Angeles County Superior Courts | Property | Medicare paid the clinic more than $3.7 million. UniCourt uses cookies to improve your online experience, for more information please see our Privacy Policy. Internal company records obtained by The Post show that Liveyon received reports of patients falling ill and testing positive for E. coli as early as June 5, 2018 nearly four months before the recall. Most of the Southern California cases stemmed from a compounding pharmacy scheme targeting TRICARE. They may contain other kinds of cells, but not cells that have been shown to repair tissue, or they may not contain live cells at all. x+r But in the absence of conclusive studies, its hard to know whether the improvement comes from something in the cells themselves or from the considerable power of the placebo effect. Fire Ants Have Unleashed Chaos in Texas for Decades. (dg) [8:16-mj-00325-DUTY] (Entered: 06/23/2016) Main Doc ument Buy on PACER 4 Jun 21, 2016 Malpractice attorney Hartley Hampton, of Houston, says they had no way of knowing otherwise. endobj Liveyon LLC filed as a Domestic Limited-Liability Company in the State of Nevada on Friday, June 10, 2016 and is approximately seven years old, according to public records filed with Nevada Secretary of State. When she finally arrived, she found her mother in the intensive care unit, hooked up to machines. c. Step 3.4 states that investigations shall be initiated on the day information is received by QA. However, complaint investigations were not initiated on the day of receipt by QA. We realized that theres a systemic problem.. In real stem cell therapies, we do pay close attention clinically to numbers of stem cells, he says. John W Kosolcharoen Liveyon, LLC Defendants Alliance Auto Group, Inc. William A. Paige Attorney/Law Firm Details Plaintiff Attorney Hateley & Hampton Court Documents MINUTES FINALIZED FOR EX PARTE 08/02/2019 08:30:00 AM. Website: Headquarters: Irvine, CA Size: 51 to 200 Employees Type: Company - Private Revenue: Unknown / Non-Applicable Competitors: Unknown 3.4 4 Ratings "Great" Nov 26, 2021 - Sales Associate Advice to Management Keep up the good work Diversity & Inclusion at Liveyon ( 2 Reviews) Liveyon Interviews Experience Positive 100% CIVIL CASE COVER SHEET FILED BY LIVEYON, LLC; KOSOLCHAROEN, JOHN W ON 06/06/2019, SUMMONS ISSUED AND FILED FILED BY LIVEYON, LLC; KOSOLCHAROEN, JOHN W ON 06/06/2019, COMPLAINT FILED BY LIVEYON, LLC; KOSOLCHAROEN, JOHN W; INFINITY MARKETING, INC. ON 06/06/2019. After years of minimal regulation of the stem cell industry, the FDA issued guidelines in 2017 making clear that many products are unapproved drugs being marketed illegally. John K, as hes referred to in the podcast, was more than happy to talk to her because he did not see himself as the villain, which made the story more complicated. He will turn 45 in June. Her mother had a few injections into her shoulders, then was told that she should also have shots into her back, which would be administered by an affiliate, a pain-management specialist shed never met in an office shed never seen, in west Houston. We report on vital issues from politics to education and are the indispensable authority on the Texas scene, covering everything from music to cultural events with insightful recommendations. It was just too many sensational claims, Hardy said. FDA issues warning after a dozen people get sick from stem cell treatments, What you should know about stem cells, from promising research to dubious uses. He returned home to Orange County on crutches. The contents were then transferred to a syringe and injected. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an IND in effect as specified by FDA regulations [21 U.S.C. For example: i. His arraignment was set for July 18. Liveyon CEO John Kosolcharoen granted reporter Laura Beil an extensive interview that offered insights into the current business of stem cell therapy, which the FDA has long been trying to. She was queasy when she watched surgery for the first time (a knee replacement) especially when a drop of blood splattered in her notebook! Contact the writer: 714-796-3686. Kosolcharoen and Gaveck said it would have taken too long to set up their own manufacturing operation, so they turned to Exeligen Scientific in San Diego. One of my clients was hospitalized for fifty-plus days, and he tells these stories of hallucinations that were so vivid and so serious that he developed post-traumatic stress disorder.. Neither Genetech nor Exeligen could be reached for comment. At the close of the inspection, FDA investigators issued a Form FDA 483 to Erin M. Sairafe, Chief Compliance Officer for both Liveyon Labs and Liveyon LLC, listing inspectional observations, which described a number of significant deviations from CGMP and CGTP. The Federal Trade Commission has targeted some clinics for making false claims. I had to say something, and I started telling him, Look, have you checked into this? Liveyon LLC | 5,290 followers on LinkedIn. They get criticized on both sides. The case status is Not Classified By Court. Specifically, your validation LL-VAL-010, entitled Validation of Biological Safety Cabinet Cleaning, v1, failed to challenge your procedures and cleaning agents to determine efficacy. For example: a. Liveyon Labs failed to conduct surface and active air environmental monitoring from January 20 to February 16, 2019. The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood.They have also been warned regarding significant deviations from current good tissue practice . PAYMENT RECEIVED BY LEGALCONNECT FOR 194 - COMPLAINT OR OTHER 1ST PAPER IN THE AMOUNT OF 435.00, TRANSACTION NUMBER 12566818 AND RECEIPT NUMBER 12390786.

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