Life Sciences

Dealing with compliance issues and criminal investigations

■Ongoing Support in Complying with Various Regulations We have assisted our clients in connection with their various regulatory needs, including, without limitation, regulatory advice on pharmaceutical regulations, such as the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceutical and Medical Devices, as well as various regulations regarding advertising and labeling, such as the Fair Competition Code, the Act against Unjustifiable Premiums and Misleading Representations, the Health Promotion Act and the Food Labeling Act. ■ Responding to Compliance Violations and Investigations Our firm, whose members include former prosecutors, responds when compliance violations are discovered within our clients or when investigations are conducted by the authorities. Depending on the situation, such responses may include conducting internal investigations within the client, conducting independent investigations by third party committees, and dealing with the authorities.

INSIGHTS

PROFESSIONALS

Junichi Kondo
JunichiKondo
Tokyo
Partner
Tokyo

Partner

Contact
Junichi Kondo is a partner at Anderson Mori & Tomotsune and is engaged principally in the fields of general corporate matters with an emphasis on M&A, joint venture and other corporate transactions including M&A-related financing. His scope of experience also includes healthcare matters including pharmaceutical regulations and software licensing.
Yoshimasa Dan
YoshimasaDan
Tokyo
Partner
Tokyo

Partner

Contact
Yoshimasa Dan is a partner at Anderson Mori & Tomotsune and has been involved with various types of corporate transactions including international and domestic M&A matters. Mr. Dan frequently assists his clients which intend to do business in Japan from legal and strategic perspectives. Mr. Dan has also provided a wide range of legal services depending on clients' needs, including in the areas of corporate law, trade law, antitrust law, securities law, employment and labor law, contract law, tax law, etc.
Tsutomu Miyano
TsutomuMiyano
Tokyo
Partner
Tokyo

Partner

Contact
Mr. Miyano's practice, through over 35 years of his professional carrier, covers really a wide range of areas, including general corporate, commercial transactions, M&A, labor issues and international finance (including securities issuance). He also handles litigations and other dispute solutions and crisis management for corporate clients. So, he is the real "general corporate" lawyer himself. Amongst his wide coverage of practice areas, he has been acting as a regular counsel for several medical device and pharmaceutical companies in Japan and also involved in many transactions relating to them (such as M&A, establishment of joint venture, etc.). He also represents many clients in the telecommunication business sector. He is also knowledgeable regarding restructuring of defaulted bonds (including sovereign bonds), the conducting of related bondholders' meetings.
Shinji Kusakabe
ShinjiKusakabe
Tokyo
Partner
Tokyo

Partner

Contact
Shinji Kusakabe specializes in advising on legal issues in manufacturing, such as commercial transactions and product liabilities. Mr. Kusakabe has a wealth of practical experience in litigation and arbitration, both international and domestic. Mr. Kusakabe's particular specialties lie in providing targeted advice to clients on corporate matters, taking into consideration potential future disputes, and in resolving current disputes in light of actual business practices and circumstances. Cases which Mr. Kusakabe has recently handled include lawsuits related to termination of commercial relationships, illegal transactions conducted by employees, product liability, bid-rigging conspiracies and inventions by employees. Mr. Kusakabe is also actively engaged in international arbitration, including matters arbitrated outside Japan. In addition to his professional experience at Anderson Mori & Tomotsune, Mr. Kusakabe's prior experience includes working as a Foreign Associate at Kelley Drye & Warren's New York office (September 1999 to August 2000) and a full-time secondment to Swiss Bank Corporation's (now UBS AG) Tokyo Legal & Compliance department (February to July 1998). Mr. Kusakabe also served as: Executive Director, the Headquarters for Comprehensive Promotion of Civil Justice Reform of the Japan Federation of Bar Associations (from June 2026); Member of the Advisory Committee for the Establishment of Civil Rules of the Supreme Court (from August 2025); Special Assistant to the President of the Japan Federation of Bar Associations (from April 2025 to September 2025); President of the Daini Tokyo Bar Association (from April 2024 to March 2025); Vice President of the Japan Federation of Bar Associations (from April 2024 to March 2025); Expert Member of the Nuclear Damage Compensation Dispute Review Board (from June 2022 to June 2023); Member of the Code of Civil Procedure (for Introduction of IT) Subcommittee of the Legislative Council of the Ministry of Justice (from June 2020 to February 2022); Governor of the Japan Federation of Bar Associations (from April 2020 to March 2021; Executive Governor from June 2020 to March 2021); Chair of the Committee on Civil Procedure of the Japan Federation of Bar Associations (from June 2019 to May 2021); Examiner for the National Bar Examination and the National Preliminary Bar Examination (in Charge of the Code of Civil Procedure) (from November 2018 to November 2021); Vice President of the Daini Tokyo Bar Association (from April 2017 to March 2018); and Practicing-Attorney-Professor for Civil Advocacy at the Legal Training and Research Institute of the Supreme Court of Japan (from April 2010 to March 2013) (for details of this position, please visit http://www.courts.go.jp/english/institute_01/institute/index.html#Intro ).
Akira Moriwaki
AkiraMoriwaki
Tokyo
Shanghai
Partner
Tokyo
/
Shanghai

Partner

Contact
Akira Moriwaki's legal practice in China first began in 1998, back when doing so was still a relatively rarity amongst Japanese lawyers. He continued to practice in Beijing until 2007, during which time, he dealt with a large variety of legal issues encountered by Japanese companies then entering into the Chinese market. Although the main focus of his work continues to remain in China related business matters, since returning to Japan he has used his unique experiences to widen his areas of interest to include other Asian jurisdictions, such as Hong Kong, Taiwan, India, Malaysia, Indonesia, Vietnam, Thailand, Korea, Singapore and Myanmar. Akira is highly experienced in a wide range of fields, such as green-field direct investment into Asian jurisdictions, M&A, private equity and Competition law. Through over a decade of experience, he has come to be recognized as one of the foremost and most experienced Japanese lawyers in international trade issues, such as anti-dumping and countervailing duty. For over 3 years, Akira has provided invaluable support to Japan's ODA project relating to the promulgation of Chinese Company law, Competition law and other distribution regulations, and he was also involved in the promulgation of Tort Law of China. Since 2009, he has been conducting lectures in Mandarin Chinese as a visiting professor at Renmin University of China (RUC) Law School. In December 2012, he was ranked first in the "overall ranking" and second in the "companies choice ranking" under the Foreign Law division of the Nihon Keizai Shimbun "Most active lawyer of the year" awards.
Yoshikazu Iwase
YoshikazuIwase
Tokyo
Partner
Tokyo

Partner

Contact
Yoshikazu Iwase joined Anderson Mori & Tomotsune after working with an intellectual property firm in Tokyo for three years. His litigation experience involves a number of patent infringement trials and revocation suits against the trial decisions of the Japanese Patent Office concerning patentability/validity of patents over various technologies. He has also been involved with a wide range of trademark/trade dress and copyright infringement suits, licensing and IP assets transfer transactions, and dispute resolution. Mr. Iwase has provided a wide range of advice regarding U.S. patent infringement issues in Japan. His experience also includes drafting and negotiating licensing, patent and various intellectual property transfer agreements, transactions and due diligence of intellectual property in the course of M&A deals.
Kazuhilo Kikawa
KazuhiloKikawa
Tokyo
Partner
Tokyo

Partner

Contact
Utilizing his twelve years of experience in the Ministry of Justice and the Prosecutors' Office, Mr. Kikawa represents domestic and foreign clients in administrative and criminal investigations by various enforcement agencies, and in complex commercial, administrative, and consumer disputes. He also has extensive experience in advising on internal investigations into legal violations and corporate scandals, and on compliance with applicable laws and regulations. Although his range of legal practice is broad, he has particular expertise in the following areas. 【Advertising and marketing regulations】 Mr. Kikawa advises clients on advertising and marketing regulations, including matters governed by the Misleading Representation Act, the Pharmaceutical Advertising Regulations, the Medical Advertising Regulations, and the Mail Order Sales Regulations under the Specified Commercial Transactions Act. He provides legal services at various stages, from preventive advice to defense against administrative investigations. 【Healthcare-related regulations and medical disputes】 Mr. Kikawa provides comprehensive legal advice on matters governed by medical, pharmaceutical, and healthcare laws and regulations, including the Medical Care Act, the Medical Practitioners’ Act, and the Pharmaceuticals and Medical Devices Act. He also represents medical institutions and medical professionals in disputes arising in the healthcare field, drawing on his experience as Chief Prosecutor for Medical Affairs at the Tokyo Prosecutors' Office. 【Immigration】 Drawing on his experience at the Ministry of Justice, where he drafted the amendments to the 2009 immigration reform, Mr. Kikawa offers reliable legal advice on visas and immigration matters and represents clients in immigration cases. 【Criminal law】 Mr. Kikawa advises clients on a wide range of criminal matters, including bribery, gambling, immigration and extradition matters. He also represents victims in filing criminal complaints and seeking criminal remedies in cases involving fraud, embezzlement, breach of trust, and misappropriation of trade secrets. 【Administrative investigation defense】 Mr. Kikawa defends clients against administrative investigations by enforcement agencies under various laws and regulations. He focuses on defense strategies aimed at avoiding the imposition of serious administrative sanctions, such as revocation of business licenses, suspension of operations, cease and desist orders or monetary penalties. These defenses are implemented during voluntary inquiries, written representations, in-person hearings, and preliminary injunction proceedings. 【Internal investigations】 Mr. Kikawa conducts internal investigations into legal violations and corporate scandals. He brings extensive experience investigating corporate crimes, including embezzlement and breach of trust, as well as handling incidents related to product quality and safety.
Hiroshi Ishihara
HiroshiIshihara
Tokyo
Partner
Tokyo

Partner

Contact
Hiroshi Ishihara specializes in international and domestic corporate law matters including M&A, business reorganization, antitrust law, real estate and intellectual property transactions. In connection with M&A transactions, he has extensive experience in cross-border M&A, business integration between listed companies, joint ventures and intragroup reorganizations. Also, he advises on many international commercial transactions, such as negotiation for a license agreement, manufacturing agreement and other agreements between Japanese and overseas companies. For domestic corporate matters, he advises on corporate crisis management and operation of shareholders’ meetings. He also specializes in healthcare and life sciences industry and handles many transactions and regulatory issues, including regulations with respect to regenerative medicines. Prior to joining Anderson Mori & Tomotsune, Hiroshi served as a lawyer at Nishimura & Asahi, Kirkland & Ellis LLP and Bingham Sakai Mimura Aizawa. Also, He has experience working for the Bank of Japan as well as one of the largest general trading companies in Japan. Hiroshi is a qualified Japanese lawyer (bengoshi) as well as a qualified lawyer in New York and California.
Tomoki Debari
TomokiDebari
Tokyo
Partner
Tokyo

Partner

Contact
Since joining the firm in 2001, Tomoki Debari has been involved principally in the fields of insurance, banking, securities and asset management, as well as M&A projects involving insurance companies and other financial institutions. He has extensive experience representing Japanese and foreign insurance companies in various matters in Japan, including: (a) formation of branches, subsidiaries and insurance joint venture companies in Japan and applications for insurance business licenses; (b) acquisition of shares in insurance companies and/or portfolio transfers; (c) demutualization and other structural changes, including conversion of Japanese branches into subsidiaries licensed to conduct insurance business; (d) strategic alliances and mergers involving insurance companies; (e) outbound investment and/or formation of joint ventures in the U.S., Europe and Asia (including Vietnam, Turkey, Thailand and Singapore) by Japanese insurers; (f) development of new life and non-life product lines; (g) asset management (including real estate, funds and various derivative transactions); (h) reinsurance transactions and ancillary hedging transactions; (i) ongoing advice on all major issues relating to the Insurance Business Act and Insurance Contract Act; (j) litigation and alternative dispute resolution (including disputes relating to reinsurance); and (k) FSA inspections. As an additional area of specialization, Mr. Debari has also developed extensive expertise in environmental law matters. He assisted Japan's Environmental Ministry in its development of the Soil Contamination Countermeasures Act of Japan, adopted in 2002, and since then has advised clients on a wide variety of environmental issues, including: (i) development of environment impairment liability policies and environment remediation expense policies for several insurance companies; (ii) numerous real estate projects in which analysis and management of environmental risks played a key role, including sales, transfers, securitizations and M&A transactions; (iii) global studies by clients in the areas of soil, groundwater, and air contamination (including one such study for a major U.S. airline); (iv) development by clients of emergency reaction and contingency plans against soil and groundwater contamination; and (v) dispute resolution (including both litigation and alternative mechanisms) regarding environmental issues between joint venture partners, as well as with local governments and the public.
Akitaka Anzai
AkitakaAnzai
Tokyo
Bangkok
Malaysia
Partner
Tokyo
/
Bangkok
/
Malaysia

Partner

Contact
Akitaka Anzai is a partner of Anderson Mori & Tomotsune working primarily in the filed of Japan-Southeast Asia related matters, such M&A, establishment of Joint Venture companies, labor issues or disputes in Southeast Asia countries including Malaysia and Thailand, and working on the capital market transaction, such as issuance of the equity or debts by the domestic and foreign companies and Islamic Finance.

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