Our Life Sciences team is a multi-disciplinary group of lawyers providing specialist services to the life sciences sectors. The disciplines covered by the Unit include intellectual property, technology and commercial contracts, regulatory, corporate, banking, property and litigation which are tailored to the requirements of biotechnology, pharmaceutical, medical devices and diagnostic industries.
The specialists on the team cover a broad range of issues relevant to the life sciences sectors including the following:
- CRO managed Clinical Trials (both HSE and NHS based)
- Research, collaboration, development and commercialisation arrangements
- Inter-group licensing of intellectual property in pharmaceuticals and medical devices
- Intellectual property ownership, licensing, assignments and technology transfers
- Manufacture and distribution arrangements
- Warehouse distribution services
- Advising on EMA and Health Products Regulatory Authority requirements
- Intellectual property protection, registration and disputes
- Product liability
- Sector specific competition law
- Venture capital, private equity, IDA grant agreements and other fundraising structures
- Corporate restructuring, joint ventures, mergers and acquisitions
- Litigation and dispute resolution
- Advising Kinetic Concepts, Inc. the leading global medical technology company involved in the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound care, regenerative medicine and therapeutic support system markets. Marco has advised this client since their establishment in Ireland in relation to various matters. The firm provides a full range of legal services to this client’s group including corporate, company law, corporate set up, data protection and employment.
- LK Shields advises Welch Allyn, the well-known US manufacturer of medical diagnostic devices, patient monitoring systems and miniature precision lamps, on an ongoing basis. This client is based primarily in the United States but has manufacturing, sales, and distribution facilities located throughout the world including Ireland. The firm provides a wide range of legal services to the group regarding its Irish entities, particularly on shareholding structures, commercial contracts, employment issues and competition and regulatory matters.
- Advised a major US multinational life sciences group in the process of restructuring its group operations in Europe, including the closure of a manufacturing facility in Ireland which involved following a tax driven structure and addressing many legal issues in different areas including supply arrangements, customs matters, data protection, IDA Grant Agreements, employment and commercial property.
- The firm acted for a major multinational group in relation to its recent investment in a highly regulated medical devices manufacturer based in Galway. This client is a global custom manufacturer for the medical device and healthcare industries. Marco advised the group on regulatory and corporate issues relating to the implementation of the revised corporate structure and the integration of the acquired entity in an efficient manner.
- Advised a multinational producer of medical devices on a range of Irish law and regulatory issues since its acquisition of a manufacturing plant in Ireland. This client is a subsidiary company of a multinational group which produces regulated medical devices such as orthotics, braces and back supports.
- Advised Eli Lily, a leading innovation driven pharmaceutical group on various regulatory issues. This client has a first class portfolio of pharmaceuticals and has a large manufacturing plant in Co. Cork which has become a centre of excellence in biopharmaceutical manufacturing technology.
- The firm advised a global medical technology company with an annual turnover of app. €700m, and 4,200 employees, serving the needs of acute and long-term care facilities. Marco advised on a confidential question of whether certain practices on the part of the HSE amounted to an anti-competitive practice. This project also included advising on national Public Procurement legislation from the client’s perspective, specifically on whether the practices in question implement the relevant EU Directives’ underlying principles such as transparency, fairness and proportionality apply.
- Acted for specialist packaging firm Venture Packaging in the sale of the company to US multinational Cardinal Health.