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Sinéad Oryszczuk is special counsel and solicitor advocate in Covington's London Life sciences and Environment regulatory team. Ms. Oryszczuk’s UK and EU law practice is diverse, spanning energy, environment, life sciences, consumer products, and technology sectors. She supports a variety of internal and in-house teams including corporate, real estate, projects, construction, planning, health and safety, IP, insurance, and banking. She is experienced in contentious matters, assisting clients before criminal, civil, administrative and specialist tribunals, and non-contentious (regulatory, transactional/M&A) matters. She has advised in relation to some of the UK’s most high profile recent environment cases up to Court of Appeal level, as well as large group actions, and has brought cases before the European Court in life sciences matters. Prior to joining the firm, Ms. Oryszczuk spent 5 years in the UK's leading specialist energy, environment, and regulatory team.

  • Representing GE Healthcare in European General Court proceedings against the European Commission’s decision to suspend its medicinal product’s marketing authorizations, including application for interim relief.
  • Advising life sciences multinational on national and international compliance requirements under the Nagoya Protocol on access to and benefit sharing of genetic resources in 17 countries.
  • Acting for medicinal products manufacturer in appeal against UK regulator’s (NICE) reimbursement decision.
  • Advising various medical devices and electronic equipment manufacturers on EU and UK compliance regimes concerning RoHS, REACH, biocidal products, electromagnetic compatibility (EMC), low voltage (LVD), machinery and WEEE, including in respect of regulator notifications and mitigation/recalls.
  • Coordinating high profile consumer product recall including regulator notifications.
  • Assisting medical device manufacturer in contentious CE mark renewal process.

Transactional (Corporate and Real Estate)

  • Numerous international funds in relation to purchases of manufacturing and industrial businesses and facilities. For example: advised Canadian investor in competitive tender situation relating to purchase of international mines and minerals operations including coordination of due diligence across multiple practice areas, undertaking specialist environment due diligence and advising on parent company/D&O liability.
  • Day-to-day experience undertaking environment due diligence and vendor due diligence, drafting and negotiating environment indemnities and warranties, transfer and allocation of liability including drafting of environment liability deeds. For example: advised a chemicals recycling and waste management group on its purchase of an active UK landfill business including complex permitting and regulatory matters, planning, allocation of liability and nuisance matters.
  • Provided specialist environment advice in numerous redevelopment projects including major redevelopments in London involving highly contaminated land, hazardous substances (including asbestos) and dangerous premises and objects. Also drafted site access agreements, site investigation deeds, and negotiated contractor terms and conditions. For example: provided day-to-day assistance to an aggregates group across it UK portfolio of sites including in relation to its redevelopment of London wharf and in particular on water (including abstraction) and drainage policy, permits and associated issues.
  • Negotiating lease and sale contract provisions in real estate matters including in relation to contaminated land, hazardous substances and environment liability. For example: real estate support to bio-/agri-tech companies in relation to contaminated land and hazardous chemicals.

Corporate Reporting and Compliance

  • Advised multiple international groups and particular private equity on environment and wider non-financial reporting obligations, including EU mandatory energy audit obligations and ESOS, emissions, permitting, CRC, EU ETS, including determination of responsibility/liability and drafting bespoke agreements on same. For example: produced innovative interactive tool and questionnaire for energy consultancy on energy audits covering all 28 Member States.

Energy and Projects

  • Provided environment advice in relation to multiple large scale energy storage, grid, renewables (including wind and solar farms) projects. For example: advised renewable energy group in respect of its largest fully commercial energy storage project outside the U.S., including environment liability and contractual protections (contaminated land, nuisance, pollution/hazardous substances) and on batteries legislation.

Technology and Consumer Products

  • Numerous technology multinationals on product stewardship matters (chemical/hazardous substances, eco-design/-labelling, waste/WEEE etc.) throughout product lifecycle, from design to end of life, and in particular due diligence on new smart product launches.
  • International online retailer: in respect of use of and regulation, and advertising claims, concerning azodyes (including under REACH/CLP).
  • Major international consumer products client: on CLP requirements including producing comparative guide and risk analysis across five Member States.
  • UK based fragrance development company: on application and interrelationship between CLP, REACH, and Cosmetics Directive concerning potentially prohibited substance and other compliance requirements.
  • Consumer products company: on non-compliance and product recall situation relating to restricted substances.
  • International manufacturer and distributor of photocopying and scanning equipment: on RoHS requirements including transitional provisions and stockpiling.
  • Major international smartphone manufacturer: on chemicals/hazardous substances requirements and advertising claims in particular under biocidal products regime.
  • Major international technology client: on issues and regulatory aspects of return and/or recycling of unused and used EEE and second hand goods and drafting bespoke agreement in respect of same.

Radioactive Materials and Nuclear

  • A U.S. based buyer: acting as specialist outside counsel on its purchase of an international radioisotope manufacturer/supplier Advised on UK and international regulatory regimes/approvals relating to manufacture, storage, handling, transport (domestic and transfrontier), recycling and disposal, of radioactive sources and apparatus. Undertook due diligence/historic liability analysis, on a wide range of legal regimes (including environment, chemicals, hazardous substances, cross border/transport, licensing, import/export). Also advised on nuclear and non-nuclear licensed sites/activities, and assisted with permit/licence applications, amendments, extensions and surrender, regulator liaison and notifications. Advised target and parent company post-completion on taking the business forward.
  • Major German utility: on national and international compliance obligations and liabilities relating to take back and transboundary shipment of nuclear waste, including drafting of bespoke agreements (including settlement of historic and current liabilities).
  • An international engineering company: in relation to use, keeping, storage and disposal of historic radioactive materials in context of sale in receivership and subsequent site development, including associated liability and allocation/transfer, contractual and statutory protections and risks, and regulatory (e.g. permitting and contamination/pollution) issues.

Criminal Litigation

  • Successfully defending Red Industries (complete acquittal after six weeks Crown Court trial) in criminal proceedings in relation to one of the UK’s largest inland water pollution incidents in decades (involving alleged cyanide and ammonia release, and alleged permitting breaches relating to chemicals), including successful first instance abuse of process application, and representation to Court of Appeal level.
  • Acting for Powerday Plc in relation to two (Crown Court) complex prosecutions concerning waste management activities, including negotiation of plea, fines and confiscation.

Civil Litigation

  • Various operators: defending very large civil group actions in nuisance.

Specialist Tribunals and Inquests

  • Assisted numerous clients in relation to contentious permitting decisions including PINS appeals, appeals against enforcement decisions, FOIA/EIR requests and objections to release of information.
  • Successfully represented corporate landowner over six week hearing, in relation to high profile (Zane Gbangbola) inquest concerning alleged hazardous substance (hydrogen cyanide) release.

Life Sciences/Regulatory

  • Various biotech, product and food manufacturers on subject matter advertising, promotions and product claims rules and considerations.
  • International manufacturer on EU law considerations of development of new vaccines and on necessary approvals to bring to market.
  • Life sciences multinational on environment (packaging, waste, eco-labelling/design, permitting), regulated substances (biocidal products, CLP, REACH, RoHS) and subject specific (electromagnetic and radio equipment) commercial contract advice in relation to manufacture and supply of electronic products, including negotiation of environment aspects of manufacturing services agreement and manufacturer key performance indicators and guidelines.
  • International drinks manufacturer: on EU legislative regimes provisions relating to the sale, import and labelling of “GMO”/genetically engineered products and specifically in relation to distilled drink products produced using GMO ingredients and/or where they contain GMO traces. Also included coordination and overview of/opinion on equivalent regimes in three non-EU jurisdictions.
  • Market leading international biotechnology product development company and its subsidiary company specializing in discovery and production of molecular biology products importation: on placing on the UK market of lentiviral particle products (in particular in respect of any applicable considerations concerning genetically modified vectors in vaccines).
  • Household name consumer products company: on application to new products, of national and international access to and sharing of genetic resources legislation (namely Nagoya Protocol and EU ABS Regulation).
  • International medical equipment manufacturer: in relation to potential non-compliances with RoHS relating to its medical devices, including interpretation and application of legislation at EU and national (UK) level, and management of international investigation and response strategies (including alternatives to recall and liaison with regulators), enforcement risk, and mitigation.
  • International medical devices manufacturer: coordinating cross-border advice and advising on, national and international chemicals legislation and compliance regimes, including transitional regulatory deadlines, across five Member States (including liaising with regulators). Also compliance issues including employee whistle blowing and internal investigations.
  • Multinational biomedical research and device manufacturer: on product return/end of life considerations and arrangements, including drafting of distribution agreement(s) and product warranties in respect of same.
  • Global diagnostic device and service provider: on EU biocidal products obligations relating to research only use products.
  • International life sciences and diagnostics company: on distribution and take back arrangements of products, customer warranties, in particular REACH, CLP and biocides aspects, and drafting agreements on same.
  • International medical devices company: on inclusion of specific substances in in vitro diagnostic products, in particular under REACH and CLP.
  • Edible coatings manufacturer to pharma and other industries: in relation to (i) potential patent infringement proceedings; and (ii) importation of insect samples and derivatives for the purposes of genome sequencing.
  • Orthopaedic device manufacturing company: in relation to (i) product liability group action; and (ii) in patent review exercise in context of infringement action.

Pro Bono

  • Advising humanitarian aid charity on international regulatory regimes and considerations concerning donations of medical devices and medicines to internally displaced persons and refugees, 2017/18.
  • Since 2011, coordinator of Thomson Reuters TrustLaw Connect firm partnership, advising on, coordinating or connecting 30+ pro bono projects.
  • Led multinational team of 64 lawyers and support staff in producing 450+ page report on anti-domestic violence laws in 24 countries for Chinese NGO. Submitted in English and Mandarin to Chinese legislature and resulted in legislative change.

Memberships and Affiliations

  • UK Environmental Law Association (UKELA)
  • Led on international report on anti-domestic violence legislation for Chinese NGO, coordinating 24 jurisdictions, 64 lawyers, and support staff - recognised by FT Innovative Lawyers 2014 as "standout," shortlisted for Legal Business Awards 2014 and winner Thomson Reuters TrustLaw Collaboration Award 2013.