Lincoln Tsang

Experience

M&A Transactions

• Advised Jounce Therapeutics, Inc., US-headquartered biotech company, on its business combination via a proposed all share merger with UK-headquartered biotech company Redx Pharma plc
• Advised leading global private markets firm Partners Group, acting on behalf of its clients, on its investment in GHO Capital Partners’ portfolio company Sterling Pharma Solutions, a global Contract Development and Manufacturing Organisation
• Advised Humble Group AB, a Swedish food-tech and FMCG-group supplying the next generation of products that are good for people and the planet, on its up to SEK 1.384 billion acquisition of Solent Global Limited, a leading international supplier of healthy foods and personal care products
• Advised Avista Capital Partners and Nordic Capital and Swiss pharmaceutical company Acino on the sale of Acino to ADQ
• Advised Partners Group on its acquisition of Pharmathen, a European pharmaceutical company, from international investment firm BC Partners on behalf of its clients. The transaction values Pharmathen at an enterprise value of around EUR1.6 billion
• Advised NeoGenomics, Inc., a leading provider of cancer-focused genetic testing services and global oncology contract research services, on its acquisition – including its financing via private placement of equity – of Inivata Ltd, a global, commercial stage liquid biopsy platform company, headquartered in Cambridge, UK

Regulatory and Compliance

• Representation of companies in various decisions before the EMA’s advisory committee and European Commission relating to orphan designations and maintenance of orphan designation
• Developed research and development strategies for approval, pricing and reimbursement for pharmaceuticals, medical devices and emerging technologies, including gene therapy, cell therapy and tissue-engineered products
• Advised on regulatory data protection, market exclusivity and patent life extension
• Counseled crisis and risk management, including matters relating to supply shortages and urgent drug safety
• Advised on classification of borderline products and emerging and high technology products
• Assisted in the implementation of pharmacogenomic testing for development of personalized medicines
• Routinely appeals against decisions made by regulatory authorities, health technology agencies and pricing authorities
• Developed a global regulatory compliance process for advertising, promotion, anti-bribery and corruption, as well as good pharmacovigilance, clinical, and manufacturing practice

Legislative and Public Policy

• Advocacy before regulatory authorities, advertising/promotional regulatory bodies, and European Commission, European Parliament, and national parliaments
• Testified before the United States Senate as an independent legal and regulatory expert on matters concerning timely access to treatments for rare diseases*

Litigation and Contentious Matters

• Successful representation of an international pharmaceutical company in a pre-action judicial review application on the legality of regulatory decision-making on product approval
• Representing a biopharmaceutical company in a commercial dispute before the London Court of International Arbitration 
• Representing clients in complaint proceedings against European institutions to European Ombudsman on matters relating to breach of good administration behavior
• Representing clients in court and arbitration proceedings involving issues relating to European Community law and regulatory policy
• Assisting clients in cross-border litigation matters
• Leading recent cases European Courts: T-33/17 Amicus Therapeutics UK Ltd; Amicus Therapeutics v European Medicines Agency; T-733/17 GMP-Orphan SA v European Commission and Appeal Case C-575/19P; T-337/18 Intercept Pharma Ltd, Intercept Pharmaceuticals Inc v European Medicines Agency and Appeal Case C-576/19P against European Union General Court decision*

Government Experience

• Non-Executive Director, Board of the National Institute for Biological Standards and Control; Member, Governance and Audit Committee; Member, Scientific Policy Advisory Committee (appointed by UK Ministers) (2004-2009)
• Commissioner, British Pharmacopoeia Commission (2006-2016); Chair, Biologicals/Biotechnology Committee; Vice Chair, Nomenclature Committee (appointed by UK Ministers)
• Non-Executive Member, Regulatory Oversight Committee, Health Protection Agency (2009-2013) (appointed by UK Ministers)
• Member, UK Ministerial Industry Strategy Group (2005-2011)
• Special Advisor to Council of Europe Legal Affairs Committee (2009-2013)
• Advisor to World Health Organisation (1996-2006)
• Advisor to European Medicines Agency (1995-2002)
• Advisor to European Commission (1993-2002)
• Advisor to European Council (1993-2002)
• Advisor to Singapore Health Sciences Authority (2003)
• Advisor to Korea Food and Drug Administration (2006)
• Advisor to Gulf Cooperative Council (2008)
• EU representative on International Conference on Harmonisation; Chair of Gene Therapy Expert Group (1997-2001)
• Senior Official and Head, Biologicals and Biotechnology, Medicines and Healthcare products Regulatory Agency (1990-2002)
• Member, Medical Research Council Stem Cell Bank Steering Committee (2001-2002)
• Member, Gene Therapy Advisory Committee (1997-2002)

*Experience prior to joining Ropes & Gray