Aiko Yamada

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 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.

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.