|
Partner
| TEL |
+82-2-772-4903 |
| E-MAIL |
hyunah.song@leeko.com |
|
|
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.
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 |
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 |
Expertise
| Life Sciences · Pharmaceuticals |
| Healthcare |
| Medical Institutions |
| Healthcare & Pharma Litigation |
| Mergers & Acquisitions |
| Corporate |
| Foreign Investment |
| China |
| Regulatory Compliance |
Admissions & Qualifications
| Admitted to the Korean Bar(2012) |
Languages
| Korean, Chinese and English |
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.
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 |
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)