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Recently reviewed Professionals
Hyun Ah Song is a partner in Lee & Ko’s Corporate Practice Group and Healthcare & Life Sciences Group. Since joining the firm in 2012, she has focused her practice on the pharmaceutical, medical device, and healthcare industries, advising clients on corporate law, M&A, corporate governance, compliance, foreign investment, and China-related matters.

Ms. Song has extensive experience advising multinational companies on compliance, M&A, and market access strategies in the healthcare sector. Her practice covers a broad range of complex regulatory and transactional matters, including interactions with government authorities, fair trade and antitrust issues, ethical business practices, white-collar crime, on-site support for Korea Fair Trade Commission investigations, criminal defense in kickback cases, and the establishment of internal compliance policies and standard operating procedures. She also regularly advises on healthcare-related transactions and day-to-day operational matters, including clinical trial agreements, distribution, co-marketing and co-promotion arrangements, logistics and warehousing agreements, global license-in and license-out transactions, market access projects, data protection, and general corporate matters such as the establishment of Korean branches and subsidiaries, M&A, corporate governance, and labor and employment issues.
Representative Matters
[M&A]
Advised K Group on corporate governance restructuring.
Advised on blind pool investment in facilities for the elderly and children.
Advised HD Korea Shipbuilding & Offshore Engineering on the establishment of AMC Science and Asan Foundation's capital increase transaction; advised on technology licensing agreements between AMC Science and Asan Foundation/Ulsan University Industry-Academic Cooperation Foundation.
Advised CSL Group on the integration of its three Korean entities and the spin-off of Seqirus.
Advised MSD on the acquisition of Elanco's aquatic animal business division.
Advised Daesang Wellife on the acquisition of FNDNet.
Advised Dongwha Pharmaceutical on the asset acquisition of Celltrion Asia Pacific Pte. Ltd.'s OTC business division.
Advised on the attempted acquisition of Synapix.
Advised BioSolution on the acquisition of Helixmith.
Advised Tecan Group AG on the acquisition of Greenmate Biotech's medical device/equipment business division.
Advised BMS on the asset acquisition transaction from Orum Therapeutics.
Advised on the attempted acquisition of Boryung Biopharma.
Advised Huons Meditec on the transfer of the lithotripter business division from M.I. Tech.
Advised on the attempted acquisition of Medit.
Advised Demant Korea on the spin-off of its diagnostic equipment sales business division.
Advised Boryung Pharmaceutical on the acquisition of assets related to original drugs
Advised Kantar Group on the acquisition of its Health business division.
Advised on the spin-off of MSD.
Advised on the acquisition of Huons Biopharma.
Advised on the attempted acquisition of Takeda's major product Asian business.
Advised on the attempted acquisition of BMS's major product global business.
Advised Baxter on the transfer of its bio business division.
Advised Shire and Baxalta on stock purchase and merger for global integration.
Advised Novartis on the acquisition of its Flu business division.
Advised Alvogen on the transfer of its oral contraceptive business division.
Advised Abbott on the acquisition of St. Jude Medical.
Advised Pfizer on the transfer of its infusion therapy division.
Advised global pharmaceutical companies and medical device companies on entering the Korean market, including entity establishment.
Advised on the establishment of JVs for pharmaceutical/bio companies.
[Healthcare – Contracts & General Corporate]
Provided comprehensive advice on entering the Korean market for global pharmaceutical/medical device companies.
Provided corporate maintenance services for foreign-invested enterprises.
Drafted, reviewed, and negotiated various global and domestic clinical trial agreements, including Clinical Trial Agreements, CRO Service Contracts, IISR Agreements, NIS Agreements, PMS Contracts, and research outsourcing contracts.
Advised on contract drafting, review, negotiation, and transaction structures for License-in, License-out, and joint R&D agreements for pharmaceutical/bio and medical device companies.
Drafted and negotiated various agreements related to the distribution and promotion of pharmaceuticals/medical devices, including supply and distribution agreements and promotion/co-promotion/co-marketing agreements; advised on contract termination and related disputes.
Advised on transitional distribution service agreements and transitional manufacturing and supply agreements related to global/domestic healthcare deals, and other post-merger integration matters.
[Healthcare – Regulatory & Compliance]
Advised pharmaceutical, biotechnology, and medical device companies on compliance due diligence, compliance system design, and the development of internal policies and standard operating procedures.
Advised on CSO related issues.
Advised on third-party due diligence for CSOs and wholesalers.
Advised on MFDS/IRB approval for clinical trial plans, item licenses, business licenses, and the transfer/assignment of item/business licenses for pharmaceutical/bio and medical device companies.
Advised on structural reviews and related regulations (Bioethics Act, Pharmaceutical Affairs Act/Medical Device Act, Personal Information Protection Act, etc.) for global clinical trials.
Advised on national batch release approvals for vaccines, etc.
Advised on the designation of essential national drugs.
Advised on promotional activities, clinical trials/CRO, labeling/advertising, distribution, and import customs clearance for pharmaceuticals and medical devices.
Provided compliance advice based on the Pharmaceutical Affairs Act, Medical Device Act, Medical Service Act, Anti-Graft Act, Fair Trade Act, and Industry Codes.
Advised on the operation of patient support programs for pharmaceuticals.
Advised on post-management matters such as re-evaluation of pharmaceuticals/medical devices.
Advised on the Personal Information Protection Act regarding pharma, medical device businesses.
Advised on licensing for cell therapies, genetic testing, and specimen testing entrusted institutions.
Advised on Medical Service Act issues and unlicensed medical practices.
Advised on requirements for establishing/operating facilities for the elderly and children.
Advised on digital health matters.
Represented clients in rebate investigations/investigations.
Advised on responses to investigations, administrative dispositions and requests for official interpretations by the Ministry of Health and Welfare and the MFDS.
Represented clients in recovery dispositions under the National Health Insurance Act and Senior Long-Term Care Insurance Act.
Advised on licensing and other issues related to the establishment and operation of Robot Surgery Training Centers.
Advised on dietary supplements, including recognition of functional raw materials.
Advised on labeling, import customs clearance, and advertising for cosmetics, dietary supplements, and food products.
Provided legislative consulting in the healthcare sector.
[Healthcare – Pricing & Reimbursement]
Advised on new drug listings, expansion of health insurance coverage criteria, re-evaluation of appropriateness of health insurance benefits and defense against drug price reductions.
Advised on increasing the upper limit of drug prices.
Advised on the designation of Exit-Prevention Drugs (“퇴장방지의약품” in Korean) and related price increases.
Advised on revisions to drug price announcements.
Advised on health insurance reimbursement listing for therapeutic materials.
Advised on drug price negotiations with the National Health Insurance Service.
Advised on new medical technology assessment and procedure fee adjustments.
Advised on designation as National Immunization Program (NIP) drugs.
[China Practice]
Advisory on the establishment of a joint venture in China for Dasan Pharmaceutical.
Advisory on labeling and advertising of medical devices for the Chinese affiliate.
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Education
2019 Fordham University School of Law - LL.M.
2012 Sungkyunkwan University Law School - J.D.
2008 Sogang University - B.A., College of Chinese Culture and Management
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Work Experience
2012-Present Lee & Ko
2022-Present Member, In Vitro Diagnostic Device Expert Committee, Ministry of the Food and Drug Safety
2021-Present Member, Medical Device Advertisements Self-Regulation Committee
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Admissions & Qualifications
2012 Admitted to the Korean Bar
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Languages
Korean, Chinese and English
Awards & Recognitions
2026 Commendation from the Commissioner of the Ministry of Food and Drug Safety
2025 Selected as a "Rising Star" in the Pharmaceutical & Bio sector by Legal Times
2023 Selected as a "Rising Star" in the Medical & Bio sector by JoongAng Ilbo and the Korea In-House Counsel Association
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Publications / Presentations / ETC
Pharmaceutical Advertising (Korea Chapter): International Comparative Legal Guide (Co-author, 2021-2025)
Medicinal Product Regulation and Product Liability (Korea Chapter): A Global Guide From Practical Law (Co-author, 2021, 2022, Thomson Reuters; 2023-2025)
The Healthcare Law Review (Korea Chapter) (Co-author, 2021-2025)
Life Sciences (Korea Chapter): Lexology Getting The Deal Through (Co-author, 2020, 2021)
Pharma & Medical Device Regulation (Korea Chapter): Lexology Getting The Deal Through (Co-author, 2022-2025)
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