OCTOBER 2020 PTAB Public Hearing Schedule
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Nilotinib in Patients with Chronic Myeloid Leukemia: STAT2 Trial in Japan
Haematologica HAEMATOL/2018/194894 Version 3 Haematologica HAEMATOL/2018/194894 Version 3 Treatment-free remission after two-year consolidation therapy with nilotinib in patients with chronic myeloid leukemia: STAT2 trial in Japan Naoto Takahashi, Kaichi Nishiwaki, Chiaki Nakaseko, Nobuyuki Aotsuka, Koji Sano, Chikako Ohwada, Jun Kuroki, Hideo Kimura, Michihide Tokuhira, Kinuko Mitani, Kazuhisa Fujikawa, Osamu Iwase, Kohshi Ohishi, Fumihiko Kimura, Tetsuya Fukuda, Sakae Tanosaki, Saori Takahashi, Yoshihiro Kameoka, Hiroyoshi Nishikawa, and Hisashi Wakita Disclosures: 1. This study was supported by research funding from Novartis Pharmaceuticals to N.T. 2. N.T reports grants from Novartis Pharmaceuticals, during the conduct of the study; grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Otsuka, grants and personal fees from Pfizer, personal fees from Bristol-Myers Squibb, outside the submitted work; K.N reports grants from Zenyaku Kogyo Company, Limited, grants from Chugai Pharmaceutical, grants from Novartis Pharma K.K., grants from Kyowa Hakko Kirin Co, Ltd, grants from Nippon Shinyaku Co, Ltd, outside the submitted work; C.N reports personal fees from Novartis, grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Pfizer, grants and personal fees from Takeda pharmaceuticals, grants and personal fees from Kyowa Hakko Kirin, grants and personal fees from Otsuka Pharmaceutical, grants and personal fees from Ono Pharmaceutical, grants and personal fees from Chugai Pharmaceutical, grants and personal fees from Asahi Kasei Pharma, grants and personal fees from Shionogi, personal fees from Shire, personal fees from Jannsen, personal fees from Celgene, outside the submitted work; M.T. reports personal fees from Bristol-Myers Squib, personal fees from Pfizer, outside the submitted work; K.M reports grants from Kyowa Hakko Kirin Co. -
OSB Participant List by Research Area
OSB Participant List by Research Area Contact Centers (CC) • AARP • Air Products and • American Drug Stores Chemicals • AAA • ABB • American Electric Power • Airbus • Accor • Abbott • American Express • Alcatel Lucent • American Electric Power • Abengoa • American International • Alcoa Group • American International • Abu Dhabi National Group Energy Company • Alcon • American Stores Company • Austin Energy • ACC Limited • Alfa • American Water • Bank of America • Access Insurance Holdings • Algonquin Power & • Amgen Utilities • Blue Cross Blue Shield • Accord Holdings • AMIL • ALH Group • Charles Schwab & • ACE • AmInvestment Bank Company • Alitalia • Acea • AMR • Citigroup • ALK Abello • Acer • Amssi • Citizens Gas • Alkermes • Acxiom • Amtran Logistics • Clarke American • Allergan • Adelaide Clinic Holdings • Andrew Corporation • CPS Energy • Alliance & Leicester • Adidas • Anglian Water Services • Direct Energy • Alliance Boots • Advance Food Company • Anritsu • Federal Reserve Bank of • Alliant Techsystems Minneapolis • Advance Publications • Anschutz • Allianz • John Deere • Advanced Coating • Apache • Allied Irish Banks • Technologies Louisville Water Company • Apex Equity Holdings • Advanced Semiconductor • Allstate Insurance • Manila Electric Company Engineering Company • Apple • • • Mellon Financial Adventist Health System Ally Financial • Arcadia Housing • • • MetLife Aegon Alon USA Energy • Arcos Dorados Holdings • • • Morgan Stanley AEON AlpTransit Gotthard • Ardent Health Services • • • NetBank Aera Energy Alstom • Argos • -
ANNUAL REPORT 2016 Corporate Philosophy
ANNUAL Otsuka Holdings Co., Ltd. ANNUAL REPORT 2016 REPORT 2016 For the year ended December 31, 2016 Corporate Philosophy Creating innovative products These words embody our commitment to: Contributing Improving to the human health lives of people worldwide In keeping with this corporate philosophy and the Otsuka mottos of Jissho (Actualization) and Sozosei (Creativity), the Otsuka Group strives to utilize its unique resources and skills to develop differentiated scientific solutions which contribute to the lives of people worldwide in the form of innovative and creative products ranging from pharmaceuticals to consumer products. We are striving to cultivate a culture and a dynamic corporate climate reflecting our vision as a healthcare company. Consistent with this approach, we are dedicated to achieving global sustainability, to our relationships with local communities, and to the protection of the natural environment. Contents About Otsuka Creating Corporate Value Corporate Philosophy Corporate Governance ............. 42 Directors, Audit & Supervisory Business Model ......................... 02 Board Members ........................ 48 Corporate Social Business Segments ................... 04 Responsibility ........................... 50 Financial and Non-Financial Finance & General Information Highlights ................................. 06 Financial Summary ................... 54 Consolidated Financial Statements ................ 56 Message from the President ..... 08 Group Structure & Overview of Main Operating Companies ..... -
A-1256 Withdrawal of Thiopurines in Crohn's Disease Treated
Conflict of Interest T. HISAMATSU. Honoraria: EA pharma Co. Ltd., AbbVie GK, Celgene K.K., Janssen Pharmaceutical K.K., Pfizer Inc., Mitsubishi Tanabe Pharma Corporation, Kyorin Pharmaceutical Co. Ltd., JIMRO Co. Ltd., Mochida Pharmaceutical Co., Ltd., Nichi-lko Pharmaceutical Co., Ltd. Commercial research funding: EA pharma Co. Ltd., AbbVie GK, Daiichi-Sankyo Co. Ltd., Takeda Pharmaceutical Co. Ltd., Pfizer Inc., Mochida Pharmaceutical Co., Ltd, Nippon Kayaku Co. Ltd., Kyorin Pharmaceutical Co. Ltd., JIMRO Co. Mochida Pharmaceutical Co., Ltd., Astellas Pharma Inc., Asahi Kasei Medical Co., Ltd., ZERIA Pharmaceutical Co. Ltd. S. KATO. Honoraria: Mistubishi Tanabe Pharma Corporation , Janssenn Pharma K,K. R. KUNISAKI. Honoraria: AbbVie GK, EA pharma Co. Ltd., Janssen Pharmaceutical K.K., JIMRO Co. Ltd., Kissei Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Kyowa Hakko Kirin Co. Ltd., Nioppon Kayaku Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co. Ltd., ZERIA Pharmaceutical Co. Ltd. Commercial research funding: AbbVie GK, EA pharma Co. Ltd., Janssen Pharmaceutical K.K., JIMRO Co. Ltd., Kissei Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Kyowa Hakko Kirin Co. Ltd., Mitsubishi Tanabe Pharma Corporation, RPM Co. Ltd, Takeda A-Pharmaceutical1256 Co. Ltd. M. MATSUURA. Honoraria: AbbVie GK, Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Mochida Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Nioppon Kayaku Co. Ltd., Kissei Pharmaceutical Co. Ltd. Commercial research funding: AbbVie GK, Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., Mochida Pharmaceutical Co., Ltd., Nioppon Kayaku Co. Ltd., JIMRO Co. M. NAGAHORI. Honoraria: Kissei Pharmaceutical Co. Ltd., WithdrawalTakeda Pharmaceutical Co. Ltd., Kyorin ofPharmaceutical thiopurines Co. Ltd., Mochida Pharmaceutical Co.,in Ltd., AbbVieCrohn’s GK, Mitsubishi Tanabe Pharmadisease Corporation, Nioppon Kayaku Co. -
John E. Flaherty Ravin R. Patel MCCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, New Jersey 07102 T (973) 622-4444 F (973) 624-7070
Case 3:15-cv-07635-MLC-TJB Document 37 Filed 06/01/16 Page 1 of 13 PageID: 300 John E. Flaherty Ravin R. Patel MCCARTER & ENGLISH, LLP Four Gateway Center 100 Mulberry Street Newark, New Jersey 07102 T (973) 622-4444 F (973) 624-7070 Attorneys for Plaintiffs Of Counsel: Eric J. Lobenfeld Arlene L. Chow HOGAN LOVELLS US LLP 875 Third Avenue New York, New York 10022 T (212) 918-3000 F (212) 918-3100 Attorneys for Plaintiffs IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY : TAKEDA PHARMACEUTICAL COMPANY : LIMITED, TAKEDA PHARMACEUTICALS : Civil Action No. 3:15-cv-07635-MLC-TJB U.S.A., INC., and TAKEDA : PHARMACEUTICALS AMERICA, INC., : : AMENDED COMPLAINT FOR PATENT Plaintiffs, : INFRINGEMENT : v. : : AUROBINDO PHARMA LTD., : AUROBINDO PHARMA U.S.A., INC., and : AUROLIFE PHARMA LLC, : : Defendants. : Case 3:15-cv-07635-MLC-TJB Document 37 Filed 06/01/16 Page 2 of 13 PageID: 301 Plaintiffs Takeda Pharmaceutical Company Limited, Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc. (collectively, "Plaintiffs" or "Takeda"), for their Complaint against Defendants Aurobindo Pharma Ltd., Aurobindo Pharma U.S.A., Inc., and Aurolife Pharma LLC (collectively, "Defendants" or "Aurobindo"), allege as follows: THE PARTIES 1. Plaintiff Takeda Pharmaceutical Company Limited ("Takeda Japan") is a Japanese corporation, having a principal place of business at 1-1, Doshomachi 4-chome, Chuo- ku, Osaka, Japan. As part of its business, Takeda Japan is involved in the research, development, and marketing of pharmaceutical products. Takeda Japan manufactures lansoprazole orally disintegrating tablets. 2. Plaintiff Takeda Japan is the owner of record and assignee of U.S. -
Cases and Opinions on Clinical Trials by Japanese Pharmaceutical Companies in China
Cases and Opinions on Clinical Trials by Japanese Pharmaceutical Companies in China Man Shii Otsuka Beijing Research Institute March 22, 2012 Development Status of Japanese Pharmaceutical Companies in China Cases on Clinical Trials by OBRI Opinions on Development Status in China Development Status of Japanese Pharmaceutical Companies in China Merit for Conducting MCTs in Japan and China Chinese and Japanese are very similar in genes Nature 437: 1299-1320 (2005) 4 Japanese Basic Principles on Global Clinical Trials Japanese version English version Japanese:http://www.pmda.go.jp/operations/notice/2007/file/0928010.pdf English :http://www.pmda.go.jp/operations/notice/2007/file/0928010-e.pdf 5 Japanese Pharmaceutical Companies in China (China local corporation) 1 Eisai China Inc 18 China Otsuka Pharmaceutical Co., Ltd Kirin Kunpeng (China) Bio-Phramaceutical Otsuka Pharmaceutical Group 2 19 Co.,LTD Zhejiang Otsuka Pharmaceutical Co., Ltd Takeda Pharmaceutical (China) Co., Ltd. 3 20 Guang Dong Otsuka Pharmaceutical Co., Ltd Tianjin Takeda Pharmaceutical Company 4 Limited 21 Sichuan Otsuka Pharmaceutical Co., Ltd Sumitomo Pharmaceutical ( Suzhou) Company 5 Limited 22 Suzhou Otsuka Pharmaceutical Co., Ltd Asahi Kasei Management ( Shanghai) Company 6 Limited 23 Mitsubishi Pharma Research & Development(BeiJing) Kowa(Shanghai) pharmaceutical consulting 7 Co.,Ltd 24 Mitsubishi Pharma Research & Development(GuangZhou) Santen Pharmaceutical Co., Ltd Kyowa Hakko Pharmaceutical 8 25 Technology (Shanghai)Co.,Ltd Chugai Pharmal(ShangHai)Consulting Co., 9 Ltd. 26 Shanghai Tsumura Pharmaceutical. Co.,Ltd 10 CHUGAI Pharmaceutical Beijing Co., Ltd 27 Tianjin ROHTO Herbal Medicine Co., Ltd 11 Teijin Pharma Shanghai Consulting Co.,LTD 28 Nitto denko (Shanghai) pharmaceutical consulting Limited Senju Pharmaceutical 12 29 Shanghai Ajinomoto amino acid limited company Science & Technology(BeiJing)Co.,LTD 13 Taiho Pharmaceutical of Beijing Co.,Ltd. -
17Th DIA Japan Annual Meeting 2020 -Beyond Innovation
17th DIA Japan Annual Meeting 2020 -Beyond Innovation- November 8-10, 2020 DIAglobal.org/Japan2020 PROGRAM CHAIR Yuji Kumagai, MD, PhD Program Overview Kitasato University Hospital PROGRAM VICE-CHAIR Amidst the backdrop of the fourth industrial revolution, recent years have seen the launch of Keiichi Inaizumi, MSc initiatives related to various innovations that will create new value and bring about major changes Pfizer R&D Japan for our society. These innovations are an outcome of the creation and application of new techniques and technologies exemplified by the use of artificial intelligence, big data, and medical and genomic PROGRAM COMMITTEE information in various fields, including research and development and lifecycle management of Taro Amagasaki, PhD medical devices. Novartis Pharma K.K. Currently, the global COVID-19 pandemic has reaffirmed the importance of the role played by Nobuyuki Hanamura, PhD, MBA IQVIA Services Japan K.K. medical products in providing treatment and medications to support the health and safety of Toshiko Ishibashi, PhD, RN people everywhere. At the same time however, efforts to take on new challenges aimed at creating Ono Pharmaceutical Co., Ltd. new innovations that break away from conventional wisdom are underway around the globe. Kazuhiko Ishida, MS, RPh Astellas Pharma Inc. As society adapts to the ongoing presence of COVID-19, it is becoming more and more important Yayoi Kitawaki, MS that we actively seek to learn the latest technologies and initiatives that will underpin various Novartis Pharma K.K. innovations, consider how our jobs will change and how we should reimagine those jobs moving Yoshiko Komuro, PhD forward, and develop the skills and mindset that will allow us to respond and adapt to these major Pharmaceuticals and Medical Devices changes. -
List of Employers of Graduates
Places of Employment of Graduates from Faculty/Graduate School (Master's Program) (2012) Faculty of Letters/Graduate School of Humanities Faculty of Science/Graduate School of Science ● Tama Home Co., Ltd. ● Hitachi Systems, Ltd. ● Hankyu Travel International Co., Ltd. ● Yamazaki Baking Co., Ltd. ● Daikin Industries, Ltd. ● Nippon Telegraph And Telephone West Corp. ● Noevir Co., Ltd. ● Itochu Corp. ● Nara Women's University ● Toray Industries, Inc. ● Murata Manufacturing Co., Ltd. ● Toyo Corp. ● ShinMaywa Industries, Ltd. ● FamilyMart Co., Ltd. ● Osaka Prefectural High School ● Oji Holdings Corp. ● Sharp Corp. ● Aeon Retail Co., Ltd. ● Nikkei Inc. ● Nissen Corp. ● Kyoto Prefectural High School ● Kao Corp. ● Fujitsu Limited ● The Kyoei Fire and Marine Insurance Co., Ltd. ● The Asahi Shimbun Co. ● Yodobashi Camera Co. ● National Tax Administration Agency ● DIC Corp. ● Hitachi, Ltd. ● Institute of Physical and Chemical Research ● NTT Docomo, Inc. ● The Bank of Tokyo-Mitsubishi UFJ, Ltd. ● Osaka District Court ● Sumitomo Chemical Co., Ltd. ● NGK Insulators, Ltd. ● Sumika Chemical Analysis Service, Ltd. ● Obic Co., Ltd. ● Nippon Life Insurance Co. ● Kobe City Office ● Sumitomo Electric Industries, Ltd. ● ＴＩＳ ● Aeronautical Radio Operator ● Shinchosha Co. ● Mitsui Sumitomo Insurance Co., Ltd. ● Ashiya City Office ● Kobe Steel,Ltd. ● NEC System Technologies, Ltd. ● Teacher (JH&HS) Faculty of Intercultural Studies/Graduate School of Intercultural Studies Graduate school of Medicine (Biomedical Science) ● ASAHI BREWERIES, LTD. ● Kubota Corp. ● Kobe City Office ● Zenyaku Kogyo Co., Ltd. ● TOYO SHINYAKU CO., LTD. ● IKAGAKU ● Sumitomo Mitsui Trust Bank, Ltd. ● Kobe Steel,Ltd. ● Nippon Travel Agency Co., Ltd. ● Shin Nippon Biomedical Laboratories, Ltd. ● Quintiles Inc. ● Crest CO., Ltd. ● Softbank Corp. ● Mitsui & Co., Ltd. ● Rakuten, Inc. ● Ministry of Health, Labour and Welfare ● Mediscience Planning Inc. -
Different Aspects of Early and Late Development of Atrial Fibrillation
www.nature.com/scientificreports OPEN Diferent aspects of early and late development of atrial fbrillation during hospitalization in cryptogenic stroke Ryosuke Doijiri1, Yuji Ueno2*, Muneaki Kikuno3,4, Takahiro Shimizu5, Yohei Tateishi6, Ayako Kuriki7, Hidehiro Takekawa8, Yoshiaki Shimada9, Kodai Kanemaru3,4, Yuki Kamiya7, Eriko Yamaguchi1, Masatoshi Koga3, Masafumi Ihara10, Akira Tsujino6, Koichi Hirata8, Yasuhiro Hasegawa5, Takahiko Kikuchi1, Nobutaka Hattori2 & Takao Urabe9 The detection of underlying atrial fbrillation (AF) has become increasingly possible by insertable cardiac monitoring (ICM). During hospitalization for cryptogenic stroke, factors related to the early and late development of AF have not been studied. CHALLENGE ESUS/CS is a multicenter registry of cryptogenic stroke patients undergoing transesophageal echocardiography. Twelve-lead electrocardiogram, continuous cardiac monitoring, and 24-h Holter electrocardiogram were all used for the detection of AF. Early and late detection of AF was determined with an allocation ratio of 1:1 among patients with AF. A total of 677 patients (68.7 ± 12.8 years; 455 men) were enrolled, and 64 patients developed AF during hospitalization. Four days after admission was identifed as the approximate median day to classify early and late phases to detect AF: ≤ 4 days, 37 patients; > 4 days, 27 patients. Multiple logistic regression analysis showed that spontaneous echo contrast (SEC) (OR 5.91; 95% CI 2.19–15.97; p < 0.001) was associated with AF ≤ 4 days, whereas a large infarction > 3 cm in diameter (OR 3.28; 95% CI 1.35–7.97; p = 0.009) was associated with AF > 4 days. SEC and large infarctions were important predictors of in-hospital AF detection, particularly in the early and late stages, respectively; thus, they could serve as indications for recommending ICM. -
Japanese Listed Companies, Such As Sumitomo Corp., JT, HOYA and Dena, Have Introduced IFRS (As of Sept
Strategic Business Innovator SBI Holdings, Inc. 2012 Information Meeting November 27 Tokyo December 3 Osaka December 7 Nagoya The items in this document are provided as information related to the business strategy of the SBI Group companies and not as an invitation to invest in the stock or securities issued by each company. None of the Group companies guarantees the completeness of this document in terms of information and future business strategy. The content of this document is subject to revision or cancellation without warning. Note: Fiscal Year (“FY”) ends March 31 of the following year 1 Today’s Program Part I Explanations for the Key Questions Part II Q&A 2 Part I Key Questions 1. The major causes for the decrease in revenue and profit QoQ for 2Q FY2012 2. The measures implemented to strengthen profitability 3. Why is the Biotechnology-related Business is placed as one of the major businesses? 4. The SBI Group's mid- and long-term management strategy 5. Management's thoughts on SBI's share price 3 1. The major causes for the decrease in revenue and profit QoQ for 2Q FY2012 Key Points of 1H FY2012 Consolidated Results (1) Introduction of IFRS and group reorganization (2) Consolidated financial results (3) Consolidated results by segment 4 Key Points of 1H FY2012 Consolidated Results (1) Resolved to promptly introduce the International Financial Reporting Standards (IFRS) starting this fiscal year ending Mar. 2013, as was required by the Hong Kong Stock Exchange for the listing, and implemented group reorganization. (2) Owing to the adoption of IFRS and the group reorganization, the volatility of the consolidated financial results increased. -
Tower Hall Funabori 2016 Annual Meeting Program (Japan Affiliate)
2016 Annual Meeting Program (Japan Affiliate) Venue： Tower Hall Funabori Beyond the New Horizon: Implementation of the Global Standard 〒134-0091 4-1-1 Funabori Edogaw-ku Tokyo As of 2016/4/7 April 14 Annual General Meeting 10:00-11:00 10：00-11:00 Annual General Meeting MC: Hirofumi Suzuki Head of Secretariat Welcome Shigeru Nakamura Chairman Nomination and Election of AGM chairman 2015 Activity Report Hirofumi Suzuki Head of Secretariat 2015 Financial Report Ayako Nakajima Treasurer Ｆ 5 Main Hall 10:00-11:00 60 2015 Internal Audit Report Tsutomu Samura Japan Affiliate Auditor 2016 Action Plan Hirofumi Suzuki Head of Secretariat 2016 Budget Proposal Ayako Nakajima Treasurer Bylaw Revision Yuichi Watanabe Past Chairman 2016-2017 Election Results of Board & Officers Hiroyuki Oe Executive Director / Head of Election Committee April 14 Annual Conference 11:00－17:00 Venue Time Minutes Title Speaker Moderator 5Ｆ Main Hall 20 MC:Hirofumi Suzuki Japan Affiliate Head of Secretariat, Bayer Yakuhin, Ltd. 11:00-11:20 Welcome Remarks 2016 Japan Affiliate Chairman ISPE Japan Affiliate Becoming the First to Deliver Differentiated Value 5Ｆ Main Hall 11:20-12:20 60 Special Lecture 1 Masanori Mitsuka Mitsubishi Tanabe Pharma Corporation President Shigeru Nakamura Japan Affiliate Chairman/CM Plus Corporation -Mitsubishi Tanabe Pharma Corporation will Open up the Future of Medicine- 2Ｆ Event Hall 12:20-13:30 70 Lunch Japan Affiliate Past Chairman/ 5Ｆ Main Hall 13:30-14:30 60 Special Lecture 2 Regulatory Science Initiative and PMDA International Strategic Plan 2015 Naoyuki Yasuda PMDA Yuichi Watanabe Otsuka Pharmaceutical Co., Ltd. -
Notice of Special Meeting of Shareholders
NOTICE OF SPECIAL MEETING OF SHAREHOLDERS Dear Acucela Inc. Shareholder: Pursuant to a written demand by entities affiliated with SBI Holdings, Inc. (SBI), which collectively own more than 10% of all the votes entitled to be cast on any issue proposed to be considered at a special meeting of shareholders, a special meeting of shareholders, or “Special Meeting,” will be held at our principal executive offices located at 1301 Second Avenue, Suite 4200, Seattle, Washington 98101 on May 1, 2015 at 1:00 p.m. Pacific Daylight Time for the following purposes: 1. Hold a shareholder vote to remove the following directors from our board of directors: Peter A. Kresel Michael T. Schutzler Glen Y. Sato Brian O’Callaghan 2.To elect the following persons to fill the resulting vacancies on our board of directors in the event the first proposal is passed by our shareholders: Yoshitaka Kitao Eisaku Nakamura Shiro Mita Robert Takeuchi Any action on the items of business described above may be considered at the Special Meeting at the scheduled time and date specified above or at any time and date to which the Special Meeting may be properly adjourned or postponed. Only shareholders of record on March 19, 2015, the record date for the Special Meeting, are entitled to vote on these matters. A list of shareholders entitled to vote will be available for inspection at our offices for ten days prior to the Special Meeting. Please note that we are not asking you for a proxy and you are requested not to send us a proxy.