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Emerging Company Leaders Hear about Compensation Issues
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Peter Coode, James Kim, Chris Capel and Sam Taylor.
Cash compensation ranges and equity ownership were just two of the issues discussed by James E. Kim of Frederic W. Cook & Co., Inc at the NCBIO Emerging Companies Forum October 1. Kim told attendees that CEOs of small cap biotech companies have an average compensation range of $300,000 to 400,000 with a bonus target of 30-50% of salary.
Mr. Kim said equity options continue to be a popular compensation vehicle. He discussed equity options as compensation, which can include stock options, restricted shares and performance shares, and reviewed the advantages and limitations of each. Factors considered when determining whether to use equity compensation include business challenges such as technical hurdles, commercialization hurdles and organizational issues. Kim also discussed the impacts of change in control on severance agreements.
Mr. Kim is the head of the San Francisco office of Frederic W. Cook & Co., a national consulting firm specializing in executive compensation. The firm is the named advisor to the Board Compensation Committees of over 20% of the Fortune 1000, including companies such as Amgen, Eli Lilly, Genentech, Gilead Sciences, Inspire Pharmaceuticals, Nabi Biopharmaceuticals, Johnson & Johnson and Pfizer.
Also at the October 1st meeting, NCBIO President, Sam Taylor, updated members on the Organization’s activities and priorities for the coming year.
Smith Anderson and PricewaterhouseCoopers cosponsored of the event and a reception following the presentation.
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Med Tech Update
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NCBIO has completed an eight-week series of interviews with nearly fifty North Carolina advanced medical technologies, companies, research institutions, service providers and other organizations interested in the growth of North Carolina’s advanced medical technologies industry. In a report summarizing the interviews, NCBIO President Sam Taylor reported that there is strong support for NCBIO’s initiative to launch a new, nonprofit North Carolina Advanced Medical Technologies Center.
The interviews gave medical technologies stakeholders and opportunity to comment on a draft vision statement for the new Center. The vision statement includes three important goals for the proposed initiative, including improving medical technologies companies’ access to qualified employees, vendors and management talent; enhancing North Carolina’s national image as a location for medical technologies research; and a expanding opportunities for multi-disciplinary collaboration in the conceptualization and development of new advanced medical technologies products.
NCBIO has received a $100,000 planning grant from the North Carolina Biotechnology Center to develop a proposed business plan for the proposed Center. Approval of the proposed plan by the Biotechnology Center would qualify the new entity for up to $2.5 million in launch funding from the Biotechnology Center’s Centers of Innovation Program.
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NC Research Campus Grand Opening
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Dignitaries from around North Carolina were on hand in Kannapolis on October 20, for the dedication of North Carolina Research Campus’s new David H. Murdock Core Laboratory building. The facility, with its collection of state-of-the-art scientific equipment, will be used by North Carolina university faculty and other researchers to investigate health conditions and treatments of all types.
In addition to the Core Laboratory, ceremonies on the 20th will include the formal opening of the UNC Nutrition Institute and the North Carolina State/Dole Nutrition Institute, also located at the NCRC campus.
The North Carolina Research Campus located in Kannapolis is a collaborative of research and innovation where seven universities from North Carolina are coming together to conduct world-class research in food, nutrition, health, and disease. Joining the universities are companies from around the globe, including Dole Foods, PPD, Anatomics, Lovelace Respiratory Research Institute, Sensory Spectrum, and Carolinas Healthcare System.
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Price Leaves BMF Consulting Role
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Eric Ward, Sam Taylor, Hal Price and Norris Tolson.
NCBIO and its members recognized the work of Biotech Manufacturer’s Forum Program Manager Hal Price at a reception September 17. Price is leaving the position after nearly five years to pursue other interests. A former manager of Biogen Idec’s manufacturing facility at Research Triangle Park, Price was instrumental in the formation of the BMF.
Price led NCBIO’s efforts in the development of the NCBioImpact training initiative, which ultimately resulted in the deployment of more than $70 million in construction, equipment and program-start funding for NCBioImpact, including the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University, the Biomanufacturing Research Institute and Training Enterprise (BRITE) facility at North Carolina Central University and the North Carolina Community College System’s BioNework training program. The three programs now receive nearly $20 million a year in state funding for their operations.
NCBIO President Sam Taylor stated, "Hal believed that a state-of-the-art training program was crucial to growing the biomanufacturing industry in North Carolina, to keeping existing companies and attracting new companies. He led the way in making that vision a reality.” North Carolina Biotechnology President Norris Tolson, Golden LEAF Vice President Mark Sorrels, and BMF Chairman, Mark Paige of Novozymes also praised Price’s dedication to the training effort and to the life science industry.
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NCBioImpact Update
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North Carolina’s world-class life science training program is full of activities this fall for students and industry. The program brings together companies, the North Carolina Community College System and the University of North Carolina system in an innovative and comprehensive training program.
The NC State Golden LEAF Biomanufacturing Training and Education Center (BTEC) is in its second year of operation. BTEC officials anticipate that more than 250 students for this academic year. That’s more than a 50% increase in undergraduate student numbers. Ninety-five percent of the 163 students BTEC trained last year are in full-time positions, internships or bound for graduate school. Students at BTEC work in a simulated Current Good Manufacturing Practice (cGMP) pilot scale facility with state-of-the-art equipment and procedures.
BTEC is offering four new courses this fall: Principles and Applications of Bioseparations, Expression Systems in Biomanufacturing, Animal Cell Culture Engineering, and Tissue Engineering Technologies. BTEC has offered short courses and trained FDA inspectors. It has also partnered with ISPE and with vendors on a variety of specialized courses and topics.
North Carolina Central University’s Biomanufacturing Research Institute & Technology Enterprise (BRITE) provides hands-on training in process analytical technology and development, quality assurance and quality control. Thirty-eight courses have been developed and 31 will be offered to the 158 students enrolled in the program this fall, 110 undergraduate students and 48 graduate students. Scholarships have been awarded to 38 students. BRITE placed eight students in summer internships, and four students have graduated from the program. Two of those went to work for industry and the other two are seeking advanced degrees.
The program has been successful in enrolling community college transfer students, and has developed a number of collaborations with BTEC and community colleges. Faculty members have published research in a number of publications and have one potential patent application.
BioNetwork is a statewide initiative that networks community colleges across North Carolina to provide specialized trianing and equipment for workforce training. The system has awarded 25 Biogen Idec scholarships to students at ten different community colleges. Twenty-three community colleges were supported by BioNetwork in July with program development and other activities. The program has six specialized centers across the state and also operates a Validation Academy at the BTEC Capstone Center, run by Wake Technical Community College. The Validation Academy will offer courses in October, co-sponsored with NCSU, BTEC and ISPE.
The BioNetwork Capstone Center focuses on offering to incumbent workers, new hires and community college students hands-on, short-course-based training in biopharmaceutical and pharmaceutical operations in a simulated cGMP facility. More than 1800 students have been trained at the Capstone Center. The BioNetwork’s BioBiz Center has developed a six semester series of classes for an AAS herbalism degree. A variety of courses are being offered at the state’s community colleges this fall for degrees and for customized industry training.
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NC A&T University Receives NSF Grant and Starts Bioengineering Degrees
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North Carolina A&T State University has been awarded a grant for an Engineering Research Center (ERC) from the National Science Foundation (NSF). The award marks the first time that a historically minority university has been the lead institution of an ERC. Award funding has been approved at $18 million for the initial five years, with a potential duration of ten years. The NSF ERC for Revolutionizing Metallic Biomaterials at A&T will conduct research in the areas of biomedical engineering and nano-particle applications and will operate in partnership with the Universities of Cincinnati and Pittsburgh. It also has a global technical partner in Germany’s Hannover School of Medicine and a global cultural and outreach partner in the Indian Institute of Technology, Madras, India. California State University at Los Angeles will serve as an outreach partner in the United States.
NC A&T will also start a new Department of Bioengineering in conjunction with this ERC. The department will offer BS, Masters and PhD degrees in bioengineering. Both the University of Pittsburgh and the University of Cincinnati will collaborate with A&T in offering these degrees.
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Companies Locate at Wake Forest University Wet Lab
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Two early stage bioscience startup companies have located to the newly established Wake Forest University Babcock Demon Incubator (BDI) Wet Lab in the Piedmont Triad Research Park. The two companies are Creative Bioreactor Design, Inc. (CBDI) and Salzburg Therapeutics, Inc. Both businesses are inception stage companies requiring specific resources to develop their technology. CBDI is developing the scientific equipment needed to grow tissue and organs in the regenerative medicine market. Salzburg Therapeutics is developing nanomedicine therapeutics for prostate cancer.
The BDI’s wet lab space is now available to qualified applicants and located in the Piedmont Triad Community Research Center at Piedmont Triad Research Park. The BDI Wet Lab is designed to support emerging inception stage startups to help validate scientific technologies within a low-cost, fully equipped multi-user wet-lab space. As the project matures, the new capability enable the BDI to support six bioscience or nanotechnology startup ventures annually.
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Register for Science-Business Forum
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The North Carolina Biotechnology Center will host the Science–Business Forum: University Education for Life-Science Careers October 20. This all-day conference will bring together academic and industry leaders from North Carolina and beyond to discuss which mix of business, science, and industry-specific curricula can produce graduates with the skills most transferable to the workplace. Participants will
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Discuss innovative undergraduate and graduate curriculum models—including the Professional Science Master’s—that combine science and business education;
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Find out about the results of the National Academy of Science’s study of new master’s science education programs from Don Langenberg, Chancellor Emeritus of the University of Maryland System;
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Hear what North Carolina biotechnology employers are looking for in new hires, and get the latest on career preparation from nationally known career consultant David Jensen;
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Learn how UNC Tomorrow can stimulate change in the UNC System from Alan Mabe, Vice President for Academic Planning;
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Network with industry representatives and academic colleagues.
Click here to learn more about the Forum or to register.
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NC Biotechnology Center Awards Fellowships and Grants
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The North Carolina Biotechnology Center has announced the five sponsoring companies chosen for the first year of its Industrial Fellowship Program. The companies are:
Affinergy Inc. in Durham, which is focused on site-specific biological delivery systems; Aldagen Inc. in Durham, which develops proprietary cell therapies; BASF's plant science group in Research Triangle Park; Winston-Salem-based Targacept, a clinical-stage biopharmaceutical company; and Tengion in Winston-Salem, which develops neo-organs and tissues.
A total of 18 companies applied for the program, which pays two years of salary and benefits for a post-doctoral researcher with academic-only lab experience to work in an industrial setting. Additionally, Industrial Fellows will have access to programs in business, intellectual property, regulatory affairs and other areas to complement their training. The Industrial Fellowship Program is designed to fill a gap for scientists in need of industry experience as well as for companies in need of scientific expertise.
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Natural Biotechnology and Centers of Innovation
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To jump-start growth in the natural biotechnology sector, the North Carolina Biotechnology Center has awarded a $100,000 Centers of Innovation planning grant to an Asheville-based consortium with members from the mountains to the coast. Coordinating the planning process for the Bent Creek Center of Innovation for Natural Biotechnology and Integrative Medicine will be Annice Brown, an assistant director in the Asheville office of the North Carolina Small Business and Technology Development Center.
The Biotechnology Center started the COI program last year as a way to combine biotechnology-dependent industry sectors and North Carolina's diverse strengths to create jobs in all areas of the state. The planed Centers of Innovation are not research campuses; their goal is to virtually coordinate North Carolina research within their industry sector to enhance the commercial opportunities of nascent technologies. Three other groups have received similar grants from the Biotechnology Center, including a Piedmont Triad-based consortium focusing on the emerging field of nanobiotechnology, a group from eastern and southeastern North Carolina focusing on marine biotechnology, and NCBIO's effort to advance the state's advanced medical technologies sector.
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SEBIO Investor Forum
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Eight North Carolina companies have been selected by SEBIO to participate in its 10th Anniversary Investor Forum, an event that brings together the Southeast’s most promising life sciences venture opportunities with the regional and national venture capital community. The SEBIO Investor Forum will be held December 4-5, 2008, at the Breakers Resort in Palm Beach, Florida. The annual conference, designed to stimulate venture investment, offers an "early-stage” event focused on best practices for newly emerging companies and a "presenting companies” event which showcases a second group of young companies that have already completed one round of institutional financing.
Companies from North Carolina participating in the early-stage event are Alte Biosciences, Cary; Arbovax Inc., Raleigh; and MastCell Pharmaceuticals, Inc., Raleigh. Presenting companies from North Carolina are Argolyn Bioscience, Inc., Durham; Argos Therapeutics, Inc., Durham; Erimos Pharmaceuticals, LLC, Raleigh; LaamScience, Inc., Raleigh; and Pique Therapeutics, Inc., Durham.
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| Member News |
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Please have your organization's media/marketing coordinator send news about your company to Brenda Summers - bsummers@ncbioscience.org
Affinergy, Inc., a Duke University spinout with a proprietary site-specific biological delivery system, announced that it has been awarded multiple SBIR grants totaling $3.6 million. Two of the awards are Phase 2 grants for developing products in the orthopedic and dental markets. "Affinergy is eager to move these products into development so we can address critical patient needs," said Jonathan Gindes, Affinergy's CFO & SVP of Business Development. Our continued success in securing SBIR funding underscores the robustness of our technology across a diverse set of product opportunities."
Arbovax, Inc. has received a small-business research loan of $150,000 from the NC Biotechnology Center. The loan will support the company’s research and development program. Arbovax is an early stage company focused on commercialization of a novel technology to develop improved vaccines against arthropod-borner viruses.
Argos Therapeutics announced the presentation of positive immune response data from a Phase 1 clinical trial of AGS-004 in HIV-infected adults in combination with antiretroviral therapy (ART). AGS-004 achieved the trial’s primary endpoint of induction of T cell response to patient-specific HIV antigens. AGS-004 is a personalized HIV immunotherapy generated by the Company’s Arcelis™ technology. Arcelis is an immunotherapy platform for creating personalized, RNA-loaded dendritic cell-based therapies perfectly matched to each patient’s unique virus. AGS-004 is currently undergoing a Phase 2a proof-of-concept trial.
Argos Therapeutics has also announced the initiation of a Phase 2a trial of its AGS-003 therapy, in combination with sunitinib, for the treatment of newly diagnosed advanced renal cell carcinoma (RCC). AGS-003 is a product of the Company’s Arcelis™ technology, which is an immunotherapy platform for creating personalized, RNA-loaded, dendritic cell-based therapies perfectly matched to each patient’s unique tumor burden.
Life sciences company Entegrion had an exhibit at the annual Advanced Technology Applications for Combat Casualty Care (ATACCC) Conference in Florida in August. The ATACCC is the Department of Defense's premier scientific meeting, addressing critical advances in trauma medicine and the unique medical needs of the warfighter. Nearly all of DOD's combat casualty care scientists presented their latest research results at the conference.
Inspire Pharmaceuticals, Inc. has announced that the standard 30-day review period by the U.S. Food and Drug Administration (FDA) relating to Inspire's Investigational New Drug Application (IND) for INS117548 Ophthalmic Solution for the treatment of glaucoma has concluded and clinical testing can proceed. Inspire is currently targeting the initiation of a Phase 1 clinical trial by the end of 2008 to evaluate the tolerability and efficacy of this product candidate in subjects with early stage glaucoma or ocular hypertension.
Inspire Pharmaceuticals, Inc. has also submitted a clinical protocol and request for Special Protocol Assessment (SPA) to the U.S. Food and Drug Administration (FDA) for a pivotal Phase 3 environmental trial with Prolacria(TM) (diquafosol tetrasodium ophthalmic solution) for the treatment of dry eye disease.
Thomas R. Staab, Inspire CFO and Treasurer, made a presenation at at the Noble Financial M.A.D. Max Equity Conference, August 18. An archived version of the webcast presentation will be available on the company website for a limited time.
The T-C-Group' medical device client Curasan AG has sold its worldwide specialty dental business including its three leading products: Cerasorb(R), EpiGuide, and REVOIS(R) to Riemser AG, a German pharmaceutical company. Curasan, Inc. based in Research Triangle Park, had been marketing the family of bone regeneration and membrane products in the United States since 2004, will now be operating as Riemser Inc. at the same location. See T-C-Group for more information.
Talecris Biotherapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Gamunex (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a debilitating neurological disorder that results in muscle weakness and fatigue, which can lead to severe impairment of motor skills. Through its approval, Gamunex is the only therapy of any kind with an approved indication for the treatment of CIDP. Gamunex now has the broadest set of FDA approved indications of any liquid Immune Globulin Intravenous (IGIV) therapy. Gamunex also becomes the first and only IVIG therapy approved to treat any neurological disorder in the United States. The FDA’s ruling provides Orphan Drug Designation for Gamunex to treat CIDP.
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| At the National Level |
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Patent Reform Legislation
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood is encouraged by the patent reform legislation introduced in September by Senator Jon Kyl (R, AZ). "BIO appreciates the efforts of Senator Kyl and his staff to address the concerns of many stakeholders with the patent reform legislation currently pending in the Senate, and commends him for introducing the Patent Reform Act of 2008. This legislation is a vast improvement over previous bills in the House and Senate with respect to many of the discrete issues and concerns raised by BIO, patient groups, universities, labor unions and many other stakeholders over the past two years.”
"In particular, the Kyl legislation advances the debate on damages in a positive direction by enhancing consistent enforcement of the current law on damages and providing greater predictability for companies across all industries – but without manipulating the rules to favor infringers,” stated Greenwood. "Further, although the post-grant review provisions in the Kyl legislation would provide a second window to administratively challenge a patent, the circumstances allowing such a challenge are considerably more narrow than those in S. 1145, the Patent Reform Act.”
Renewable Energy
Biotechnology Industry Organization (BIO) President & CEO Jim Greenwood has expressed industry’s support for the U.S. Environmental Protection Agency’s decision not to grant Texas Gov. Rick Perry’s petition to waive the federal government’s Renewable Fuel Standard. "The EPA’s decision sends a strong message that we must continue moving forward toward sustainable production of advanced biofuels to reduce both our dependence on imported oil and greenhouse gas emissions from transportation, and to increase production of biofuels from non-food sources," stated Greenwood.
The Agricultural and Food Policy Center at Texas A&M University, in a study cited by advocates of the waiver, concluded earlier this year that relaxing the RFS would not significantly lower corn prices. A study by Purdue University economists shows that while biofuels have created a new demand for corn, about 75 percent of the current rise in corn prices can be attributed to the rapidly rising price of oil. Bruce Babcock, a professor of economics and the director of the Center for Agricultural and Rural Development at Iowa State University, has said that the price of corn will rise and fall in direct relation to the price of transportation fuel.
Greenwood added, "The Renewable Fuel Standard was designed to move the nation as rapidly as possible toward production of advanced biofuels made from renewable resources. The RFS specifies that 21 billion of the 36 billion gallons of biofuels to be produced and used each year by 2022 will come from non-food sources. After 2015, all increases in production and use of biofuels will come from cellulosic raw materials. Moving backward to a time where supplies of corn outpaced demand is not a possibility. We applaud the EPA’s decision not to grant the waiver.”
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| Calendar |
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October 20, 2008. Science Business Forum: University Education for Life-Science Careers. This all-day conference will bring together academic and industry leaders to discuss which mix of business, science, and industry-specific curricula can produce graduates with the skills most transferable to the workplace. Participants will examine existing curriculum models that combine science and business and look at the types of jobs available to bachelor’s and master’s level graduates. For more information.
October 22, 2008. Medtech Forum: Orthopedics - Product to Market, 5:30 - 8:00 p.m., MCNC Building # 1, RTP, $25 online pre-registration/$35 on-site registration. For more information
October 28, 2008. Charlotte Biotechnology Conference. The 7th Annual Charlotte Biotechnology Conference will provide insight from some of the most recognized biotechnology, business and research professionals from around the globe in addition to highlighting regional opportunities and investment trends within the local biotechnology sector. For more information.
October 27. Pharmacogenetics Research Network (PGRN) Scientific Meeting. The event will be held on the campus of the University of North Carolina at Chapel Hill and is being hosted by the CREATE group, a PGRN member, and the UNC Institute for Pharmacogenomics and Individualized Therapy. For more information.
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BIO, NCBIO Talk with Members of Congress on Follow-on Biologics |
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NCBIO President Sam Taylor traveled to Washington, DC, in September to hold joint calls on members of the North Carolina congressional delegation with the Biotechnology Industry Organization. BIO is working aggressively to recruit sponsors for pending follow-on biologics legislation.
BIO is supporting two bills in the current Congress, H.R. 5629, the Pathway for Biosimilars Act (Eshoo-Barton) and H.R. 1956, the Patent Protection and Innovative Biologics Act (Inslee). The two bills, which are in many ways similar, would set out rules governing the timeframes and other terms under which manufacturers of "generic” biologic drugs could bring those products to market. BIO opposes biosimilars legislation filled by Representative Henry Waxman (H.R. 1048, Access to Life-Saving Medicines Act), which provides would expose companies with innovative new biologics products to competition from biosimilars under time frames that would make it difficult or impossible to recover their development costs.
Taylor met with ten of North Carolina’s thirteen members of Congress. BIO’s federal lobbying staff also attended the meetings.
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