General Legal Service Provider Information Form

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1 General Legal Service Provider Information Form General information Name of Organisation LK Shields Solicitors Contact information Head of Organisation: Hugh Garvey (Managing Partner) Name: LK Shields Solicitors Address: 40 Upper Mount Street, Dublin 2 DD Telephone: Fax: Web Site: Brochure (please attach if available): Main contact: Deirdre Kilroy (Partner and Head of the Intellectual Property and Technology Team) Name: LK Shields Solicitors Address: 40 Upper Mount Street, Dublin 2 DD Telephone: Fax: LKS-# v1-H ealthcare_and_life_sciences_v21_14_11_12.pdf Summary of Experience: Legal The Healthcare and Life Sciences team at LK Shields Solicitors is a multidisciplinary team of lawyers who provide specialist services to the biotechnology, pharmaceutical, medical device and diagnostic industries. The disciplines covered by the team include intellectual property, data protection, technology and commercial contracts, regulatory, corporate, banking, property and litigation which are tailored to the requirements of the life sciences sector. Page 1 of 5

2 The team has a wealth of expertise and experience in dealing with complex sector specific projects. We support our clients by providing informed, commercial and practical advice at all stages of product life cycle; from providing strategic input at early-stage concept, through contract management of pre-clinical and clinical trial phases, to end-stage commercialisation and placement of product on market. We are well-informed about the latest legal and regulatory developments which impact upon our clients and are able to assist our clients in complying with all industry specific codes and regulations. The team has been involved in various significant sector specific projects in Ireland and United Kingdom. Examples of some of the work that we have done in recent years are as follows: Acting for various start-ups, university spin-out companies and industry leaders. Advising on the protection and ownership of intellectual property and technology licensing arrangements for pharmaceutical and medical devices companies. Advising on patent infringement claims and multi-jurisdictional product liability claims. Advising on various multinationals in establishing a presence in Ireland. We have advised on all Irish law issues that arise when locating in Ireland. We have assisted clients to put in place the legal structures needed to do business in and from Ireland. Acting for numerous pharmaceutical and medical-device manufacturers in obtaining EU and Irish regulatory approvals. Advising Irish and EU regulatory requirements, EU customs regimes, Intrastat, IDA Grant Agreements and inward investment (from venture capital and private equity funds). Advising on all aspects of the transfer of Marketing Authorisations and CE Marks as part of sector-specific M&A work. We have acted for seller, investor and purchaser in relation to such M&A work. We have acted on all aspects on corporate restructuring for various multinational pharmaceutical and medical devices companies. The Focus of Our Service Our healthcare and life science legal services include: Assisting with CRO managed Clinical Trials (both HSE and NHS based) and patient consent issues. Page 2 of 5

3 Research, collaboration, development and commercialisation arrangements. Ownership and protection of intellectual property, including registration of intellectual property and licensing, assignments and technology transfer arrangements. Manufacture, distribution and supply agreements. Warehouse distribution services agreements. Advising on EMEA and Irish Medicines Board requirements in respect of obtaining regulatory approvals. Advising on regulations relating to software as a medical device. Advising on contracting with Healthcare Professionals and on IPHA/IMDA Industry Codes of Practice. Venture capital, private equity, IDA grant agreements and other fundraising structures. Corporate restructuring, joint ventures, mergers and acquisitions. Sector specific competition law. Product liability. Litigation and dispute resolution including advising on patent infringement. Data protection in relation to health and life sciences. Speciality Services Offered Examples of our recent sector specific services include: Advising on Manufacture, Outsourcing, Supply and Distribution of high-end oncology generics and license of Technical File/Drug Dossiers in EU markets for purposes of obtaining marketing authorisations. Advising on Phase I/II Cystic Fibrosis Clinical Trial Agreement (HSE/CRO Managed). Advising on Patent Assignments, Patent Licensing and Collaboration Agreements in respect of non-contact sensor respiratory monitoring devices and product placement in the EU, US and Japanese markets. Advising on Development and Commercialisation Agreements in respect of cardiovascular balloon catheters and stents in EU, US and Japanese markets and advising on international funding arrangements. Advising on the Development and Commercialisation Licences in respect of gentamicin surgical implants and the transfer of Marketing Authorisation and CE Marks as part of corporate transaction. Advising on intra-group licensing of orthopaedic medicinal products and medical devices and connected manufacturing and distribution arrangements (including supply to NHS). Advising on Consortium, Collaboration and R&D Agreements in respect cardiovasculur stents (including arrangements as between university spin-out companies). Page 3 of 5

4 Advising on supply and rebrand of Augmentin (Amoxicillin) in Ireland. Advising on the licensing of drug product file management software as between GPs, Pharmacists and HSE. Advising on regulatory requirements in respect of contracting with Healthcare Professionals and Industry Codes in respect of promoting combined products (medicinal products and medical devices), and use of social media to promote combined products. What is your target audience Medical Devices, Diagnostics and Pharmaceuticals The range of services includes: As noted at Summary of Experience and at General Services. General Services: LK Shields Solicitors is a leading corporate and commercial law firm based in Dublin, Ireland. We are consistently and independently recognised as one of Ireland s leading law firms. Our clients and market commentators say that we are characterised by our pragmatism, knowledge and business acumen. In addition to being recognised as a market leader in Ireland, our people are recognised as among the country s pre-eminent lawyers. Our success is based on building long-term relationships with our clients, learning about their businesses and providing them with the solution focused advice they need. Our clients include multinationals, enterprising Irish and international businesses, public bodies, financial institutions and entrepreneurs in all industry sectors. Page 4 of 5

5 European/US/Asia Services/experience: Our HealthCare and Life Science lawyers have assisted clients on high profile, multi-jurisdictional regulatory issues, collaborative ventures, manufacturing and distribution arrangements, licensing and the protection of intellectual property. Examples of our recent multi-jurisdictional work include: Licensing of Technical File Dossiers between multiple EU partners for the purpose of securing marketing authorisations for high-end ongology generics in nominated EU territories. Liaising with US in-house counsel in respect of the securing FDA approval for placement of respiratory monitoring devices in the US market. Advising on collaboration, development and commercialisation arrangements between Irish biotech and Japense biotech partners in respect of securing regulartory approvals for respiratory monitoring devices in the Japanese market. Advising on collaboration, development and commercialisation arrangements between US owned Irish subsidiariy and Japenese biotech partners in respect of securing regularoty approvals for cardiovasular stents in the Japanese market. Page 5 of 5

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