LANDWELL Solicitors Life Sciences Unit
LANDWELL Solicitors Life Sciences Unit Our Practice Landwell Solicitors is a leading firm of business lawyers providing legal solutions to businesses in the Life Sciences sector. We are the Irish member of the Landwell international network of correspondent law firms. Established in 1999, the firm has attracted a range of senior and experienced business lawyers from the top commercial firms in Dublin and now has over 30 professionals working to deliver the highest quality legal advice to business clients. The Landwell network provides international legal services to organisations around the world and currently comprises some 2,800 business lawyers based in 40 countries making Landwell one of the world's largest legal practices. Our Team The Life Sciences unit of Landwell is a multi-disciplinary team with unrivalled legal expertise in commercial transactions, the protection and defence of intellectual property rights and the conduct of regulatory affairs. We provide advice on the full range of legal and practical issues faced by companies operating in the Life Sciences market, be they biotechnology companies, medical device companies or diagnostics companies. Landwell Life Sciences Team Edward Evans, Partner edward.evans@ie.landwellglobal.com Pauline Louth, Senior Associate pauline.louth@ie.landwellglobal.com Michelle McLoughlin, Associate michelle.mcloughlin@ie.landwellglobal.com Carol Plunkett, Partner Intellectual Property and Litigation carol.plunkett@ie.landwellglobal.com Garrett Breen, Partner Intellectual Property and Regulatory law garrett.breen@ie.landwellglobal.com Ann Brennan, Solicitor Intellectual Property and Regulatory Law ann.brennan@ie.landwellglobal.com Our Expertise Yvonne Cunnane, Solicitor yvonne.cunnane@ie.landwellglobal.com We advise leading companies in the Life Sciences industry, working closely with our accounting, tax and business advisory colleagues from PricewaterhouseCoopers, the largest professional services organisation in the world, to deliver a complete "onestop-shop" solution for the business needs of our clients. This multi-disciplinary solution delivers real value to our clients across the spectrum of their business needs including tax, financial and legal needs. Through our work with start-up companies developing new technologies to bring to the market place, with the investment community and with leading industry companies, Landwell has developed extensive expertise and experience providing specialist legal advice to Life Sciences companies from inception and planning right through to implementation and completion. In addition, as a member of the global Landwell network of law firms, we can give our clients access to specialist legal advice across over 40 jurisdictions. By linking in with Landwell's international Life Sciences network, we can provide legal solutions and advice which take full account of all local and international legal and regulatory issues. Landwell clients have the advantage of the availability to them of this unique and unrivalled international network. LANDWELL Solicitors
Working with our business advisory colleagues, we have advised and acted for many national and international clients in the Life Sciences sector. Recent projects we have been involved in include:- assisting a leading Irish university and campus based entrepreneurs to secure and protect biotechnology inventions; acting for an Irish Investment Fund providing first round financing to biotech startups; acting for an Irish Investment Fund and co-investors in second round funding for an emerging biotech company to fund an acquisition programme; advising a biotech start-up on structuring, option and incentive planning and corporate governance; advising a medical device company on corporate reorganisation. Our Industry Focus Our Life Sciences team maintain their detailed industry knowledge through their active involvement in a range of industry interest groups and their committment has been widely recognised:- Carol Plunkett has recently been appointed to the Irish Bio-Industry Association's Commercialisation Working Group. The group is developing a basic syllabus on intellectual property and patent matters for European Bio-entrepreneurs as part of the Irish contribution for an European Union backed project. The aim of the group is to address the concerns of the Life Sciences sector as regards the protection of intellectual property rights and technology transfer; the leading guide to international lawyers, Global Counsel Life Sciences Handbook 2003, recommends Landwell Partner, Carol Plunkett, as a legal expert in the Life Sciences sector in Ireland; the Legal Business 2003 European Legal Experts guide also highly recommends Carol Plunkett in Intellectual Property Litigation and Edward Evans in. Our Knowledge The Landwell Life Sciences team advises clients on a range of legal issues affecting the Life Sciences sector including the following:- Clinical Trials The Irish Medicines Board regulates clinical trials in Ireland and we can advise clients on the various procedures involved in conducting a clinical trial in Ireland. This includes advice in relation to the provision of consent by clinical trial subjects and issues of confidentiality as regards information collected on clinical trial subjects. Member states of the European Union have until 1 May 2003 to adopt and publish legislation implementing the Clinical Trials Directive 2001\20\EC (the "Directive") although practical implementation of the Directive may be delayed until 1 May 2004. The main aim of the Directive is to harmonise the laws and regulations on clinical trials across the member states of the European Union and to implement Good Clinical Practice in the conduct of clinical trials on medical products for human use across Europe. The Directive sets standards for protecting clinical trial subjects, including incapacitated adults and minors. It also outlines procedures to be followed in the manufacture, import and labelling of investigational medicinal products and in the reporting and recording of adverse reactions. The Directive provides for quality assurance of clinical trials and investigational medicinal products. We can advise you on the implications of the Directive for your business and how to comply with its requirements. Contact Carol Plunkett at - carol.plunkett@ie.landwellglobal.com Contact Ann Brennan at - ann.brennan@ie.landwellglobal.com
Medical Devices. The Medical Devices Annex to the Mutual Recognition Agreement (the "Agreement") signed by the United States and the European Union in June 1997, was put in place to coordinate the mutual recognition of medical devices in the European Union and the United States. Implementation of the Agreement has been extended until December 2003. The Agreement, when implemented, will facilitate the marketing of medical devices in both territories, for example, products authorised in the European Union may be automatically authorised in the United States and vice versa. Until the Agreement is implemented medical devices must comply with all of the regulations of both the European Union and the United States. We can advise companies on how best to prepare for implementation of the Agreement in December 2003. Contact Michelle McLoughlin at - michelle.mcloughlin@ie.landwellglobal.com Genetically Modified Organisms There is a growing body of European Directives relating to genetically modified organisms. We can appraise you of legal developments in this complex area relevant to your business. We can advise you on the legal requirements for marketing associated products including advice on labelling of foodstuffs. Contact Garrett Breen at - garrett.breen@ie.landwellglobal.com Intellectual Property It is essential that any Life Sciences company ensures that it has adequately protected and defended its intellectual property rights. This should be done in the immediate start up phase as it will secure future financial revenues flowing from intellectual property rights which properly belong to the company. Our renowned intellectual property team can explain how to do this in simple terms and they can advise you on the most economically efficient methods of doing so. We can advise on the licensing and on the assignment of intellectual property rights, including collaborative research and development agreements. In addition we can assist in the registration of your rights and in defending any attempts to abuse or invalidate your existing registered or unregistered intellectual property rights. Our intellectual property team has vast experience in dispute resolution and in developing strategies for protecting, exploiting, enforcing and valuing intellectual property rights. Contact Carol Plunkett at - carol.plunkett@ie.landwellglobal.com Contact Ann Brennan at - ann.brennan@ie.landwellglobal.com Strategic Alliances Enterprises dealing in the research, development and commercial exploitation of new products in the Life Sciences area will encounter various types of commercial structuring models and arrangements in bringing their new product to market. Alliances are often formed between enterprises to realise mutual benefits, to distribute the financial risk involved, to obtain access to new technology and/or expertise from external sources or to share the cost of research and development with either universities or more established companies. Alliances may be achieved by various means including collaboration agreements, developing and licensing agreements, bio-partnering agreements, strategic alliances and joint ventures. We can advise you on all of these partnership or alliance models and ensure that you adopt one which best suits your business needs and best protects your interests.
Strategic alliances of any type call for a combination of legal and commercial expertise in many areas, including corporate, regulatory, tax, pensions, employment and intellectual property law. It is vital that start-up companies, particularly in the Life Sciences field are aware of the key topics to be addressed in the formation of a successful strategic alliance, so as to maximise the benefits of, and protect their interests, in any such alliance. Contact Edward Evans at - edward.evans@ie.landwellglobal.com Contact Yvonne Cunnane at - yvonne.cunnane@ie.landwellglobal.com Corporate and Commercial Legal Issues. For start-ups and early stage companies, putting in place a clear, well thought out corporate and shareholder structure is very important and sets the foundation from a legal perspective for the future growth and development of the company. Landwell has a wealth of experience in corporate law and corporate structuring issues and can advise you on all your company law needs whether they relate to company formation, re-organisation, administration or compliance. Landwell can also provide advice and guidance on putting in place all of your commercial agreements and in negotiating the commercial terms of vital business relationships, whether with distributors, suppliers or customers. Contact Pauline Louth at - pauline.louth@ie.landwellglobal.com Contact Michelle McLoughlin at - michelle.mcloughlin@ie.landwellglobal.com Fundraising and Financing The ultimate aim of most Life Sciences businesses is to create a successful business and provide opportunities for wealth creation. Our team has extensive experience advising management teams, investors and promoters in relation to the full range of funding and financing options. This includes private placements, investments by State bodies, venture capital and tax based investment. We also advise on all types of realisation or exit events including buy-backs, mergers and trade sales. Our team can draw on years of experience to provide advice on how best to secure investments and maximise returns. Contact Edward Evans at - edward.evans@ie.landwellglobal.com Contact Michelle McLoughlin at - michelle.mcloughlin@ie.landwellglobal.com EU Law and Regulatory Compliance If you intend to manufacture and sell a licensed product, such as a new medical device or diagnostic kit, our regulatory lawyers can assist you to ensure compliance with European Union and national regulations and in ensuring that you meet the legal requirements concerning such issues as the labelling, advertising, marketing, wholesaling, importing and pricing of products. Contact Garrett Breen at - garrett.breen@ie.landwellglobal.com Contact Ann Brennan at - ann.brennan@ie.landwellglobal.com Related Areas of Legal Expertise Employment law, contentious and non contentious including advising on employment contracts, employee incentive schemes and pension schemes, the recruitment and application process, employment handbooks, policies, dispute resolution process, conduct of proceedings in the High court, Employment Tribunal and Equality Authority; For further information please Product liability; contact any one of the team by Litigation, medical negligence and dispute resolution; e-mail or by telephoning Irish and European Union Competition law regarding all manner of 01 662 6655 commercial and strategic agreements including distribution and supply agreements; Data Protection and Freedom of Information legislation; Environmental and Planning issues.
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