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Aiko Yamada

Counsel
+81.3.6205.3630
Fax +81.3.3597.6421
Aiko Yamada is a counsel at the firm’s Tokyo office. She is a member of the firm’s corporate/M&A and life sciences practice groups.

Ms. Yamada has over two decades experience in the legal profession. She has represented a broad range of clients with a focus on global pharmaceutical companies, global medical device companies, Japanese and U.S. biotechnology companies but also including global mobile telecommunications companies and Japanese trading companies.

Professional Background

Ms. Yamada was admitted to practice law in Japan in 2000 and in the state of New York, U.S.A. in 2007 and joined the firm in 2020.

Prior to joining the firm, she served as a counsel at a multinational law firm for 20 years where she gained experience in structuring, negotiating, and implementing various business and finance transactions. She focused her work on mergers and acquisitions, including both domestic and cross-border deals, compliance and corporate governance, and general corporate counseling. She also focused her work on policy and regulatory in the life sciences and healthcare industry and the telecommunications industry.

From April 2010 to June 2011, she was seconded to a U.S. medical device company as a full-time general counsel. From February 2012 to March 2015, she was seconded to a telecommunications company as a part-time legal counsel.

Achievements

  • Recognized Practitioner (Life Sciences - Japan) at Chambers Asia-Pacific Awards 2019
  • Noted Practitioner (Life Sciences - Japan) at Chambers Asia-Pacific Awards 2018

Professional/Civic Activities

  • Research Committee on the Judicial System, Dai-ichi Tokyo Bar Association

Speaking Engagements

  • Legal and regulatory issues in the life sciences and healthcare industry (Financial Management Forums, Inc., December 2016)
  • Legal and business issues on medical big data and gene and cell remedies (Financial Management Forums, Inc., May 2017)

Additional Information

Publications
  • Co-author, Cross-border M&A Practice (Chuokeizai-sha, Inc., July 2008)
  • Represented a Japanese pharmaceutical company in connection with various transactions such as launch of new business other than traditional Rx business; termination of partnership with a foreign pharmaceutical company; establishment of joint development with a US partner (AI venture company).
  • Represented a Japanese biotechnology and pharmaceutical company in connection with clinical trials and studies, especially investigator initiated clinical studies; various life sciences related, multi-jurisdictional regulatory and compliance matters.
  • Represented a Japanese mobile telecommunications company in connection with multi-jurisdictional advice on several ITC related projects and programs - e.g. point program, connected car project, SMS, video distribution services; documentation and negotiation for several partnership agreements with overseas partners - e.g. global IT companies, global platformers.
  • Represented a Japanese and US biotech venture company in connection with receiving investments from investors; drafting related legal documents and legal memorandum; supporting applicable filing with regulatory authorities.
  • Represented a global medical device company in connection with launching a new promotional scheme in Japan (localization of its global scheme in Japan); establishing and maintaining relationships with patient associations; documentation and negotiation for several distribution arrangements; establishing internal policies for information security -e.g. privacy policies.
  • Represented a global medical device company in connection with a tax and regulatory dispute with the authorities; import and distribution of overseas manufactured products in Japan; localizing its global policies of recycling products; reorganization of import and distribution scheme in Japan from the tax and regulatory perspective.
  • Represented a Japanese trading company in connection with several cross-border M&A and reorganization transactions such as spin-out deal for an overseas JV, a post-merger integration project in Mexico.
  • Represented a global pharmaceutical company in connection with supply agreement and warehousing and logistics agreement to launch new products into the Japanese market.
  • Represented a global pharmaceutical company in connection with various regulatory and compliance advice for Japanese regulations and overseas regulations (e.g. clinical trial sponsorship; relationship with patient group; pharmacovigilance).
  • Represented a global pharmaceutical company in connection with research and development agreements and related documents; several out-licensing agreements with Japanese partners/distributors; ongoing disputes with a Japanese partner on distribution rights; product recall; authorized generic deals.
  • Represented a global biotech company in connection with marketing and distribution agreement to launch new products into the Japanese market.
  • Represented a global medical device company in connection with Japanese regulations on promotional activities and marketing authorization in Japan.
  • Represented a global pharmaceutical company in connection with launching and marketing new products into the Japanese market; partnership deal with a Japanese distributor.
  • Represented a global medical device company in connection with marketing and distribution agreement to reorganize distribution scheme from its own channel use to distributor's channel use; partnership agreements with a Japanese partner to comply with the Japanese regulations on quality and safety control; termination with ex-Japanese partner.
  • Represented a global pharmaceutical company in connection with ongoing disputes on distribution rights on the client's products in Japan.
  • Represented a global medical device company in connection with medical advisor agreements.
  • Represented a global medical device company in connection with possible structures to launch new products in Japan; potential disputes with a Japanese partner.
  • Represented a global pharmaceutical company in connection with establishing business in Japan.
  • Represented a global pharmaceutical company in connection with ongoing disputes with a Japanese partner; documentation and negotiation of related documents.
  • Represented a global medical device company in connection with regulations on product registration, defect reporting, recall, labeling and promotional and/or advertising activities in Japan; negotiation with authorities in Japan.
  • Represented a Japanese manufacturing company in connection with newly entering into the medical device industry.
  • Advised Konica Minolta from the regulatory perspective at its acquisition of Ambry Genetics.
  • Represented a European medical device company in connection with termination of its distributorship with a Japanese partner and with the establishment of its own distribution channel and obtaining the necessary regulatory licenses and approvals in Japan.
  • Represented a US pharmaceutical company in connection with its global reorganization.
  • Represented a US medical device company in connection with its domestic and cross-border alliances.
  • Represented a Japanese pharmaceutical company in connection with its acquisition of a Swiss pharmaceutical company.
  • Advised many Japanese and foreign pharmaceutical companies and medical device companies with respect to regulatory and compliance issues, including genetic information management and relationships with healthcare professionals.
  • Represented a Japanese telecommunications company in connection with its domestic and cross-border acquisitions and alliances.
  • Represented a Japanese advertising company in connection with its acquisition of an advertising agency group headquartered in Singapore with operations in 12 Asia Pacific countries.