Lincoln Tsang

M&A Transactions

• Advised Walgreens Boots Alliance (WBA) as health care regulatory counsel in a take-private acquisition of the leading retail pharmacy by Sycamore Partners valued at up to $23.7 billion. 
• Represented Rubicon Founders in its $165 million strategic growth investment in Caidya, a leading global mid-sized clinical research organization
• Represented Eli Lilly and Company in its $2.5 billion acquisition of Scorpion Therapeutics, a clinical-stage and precision oncology company developing cancer therapies including its oral therapy, STX-478
• Represented Becton Dickinson in a definitive agreement to acquire Edwards Lifesciences' Critical Care product group, a leader in advanced hemodynamic monitoring solutions, for $4.2 billion
• Represented Cullinan Oncology in the $275 million sale of its subsidiary Cullinan Pearl, a developer of a pharmaceutical drug for cancer treatment, to Taiho Pharmaceutical
• Represented CVC Capital Partners and its portfolio company System C Healthcare on the add-on acquisition of CIS Oncology, a UK-based healthcare technology company specializing in electronic chemotherapy prescribing and patient management
• Represented ImmunoGen, a cancer treatment developer, in its $10.1 billion sale to AbbVie, a biopharmaceutical company
• Represented Advent International and Warburg Pincus in their $4.25 billion joint acquisition of Simtra Biopharma Solutions, a contract development and manufacturing business unit of Baxter International
• Represented Partners Group on its acquisition – on behalf of its clients – of a majority stake in FairJourney Biologics, a leading antibody discovery Contract Research Organization, from GHO Capital Partners

Regulatory and Compliance

• Advising a major international food manufacturer on regulatory submission to support health and nutritional claims concerning a glucoraphanin-enriched food product 
  
• Advising an agriculture company on regulation of a variety of food products based on gene-editing transgenesis to develop specific genotypic characteristics
  
• Advising on food supplements on borderline product classification and health claims of a food supplement
  
• Advising an international food nutrition company on a health claim for infant formula enriched with a fatty acid
  
• Advising a company on importation of gelatin into the EU for encapsulation for food supplements and compliance with the Specified Risk Material to prevent transmissible spongiform encephalopathies 
• 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

• Representing a biopharmaceutical company in a commercial dispute resolution governed by International Chamber of Commerce
• Co-counsel in the European Court of Human Rights case of Narbutas v. Lithuania (Application No. 14139/21)
• 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 Organization (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 Cooperation 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