This week we attended a very informative Global Medtech Compliance Conference (GMTCC) organised by…
Owing partly to our location at the centre of one of Europe’s premier medical device clusters, we first developed our fascination for the Life Sciences and began advising clients in 2008 through our offices at MG Ryan & Co.
Recognizing that our clients operate in highly regulated environments with unique business life-cycles, we quickly realised that understanding their science would be critical to our legal work. In 2011, Kevin Moore, our head of Life Sciences, became the only Lawyer in Ireland or the U.S. selected to participate in the affiliated BioInnovate Ireland and Stanford Biodesign Fellowships.
Through our work, we have gained a unique understanding of our clients industries and played a key role in the commercialisation of their research and products. MGR Life was borne of the belief that Life Science Companies should demand more of their legal advisors. We continually strive to learn more about our client’s industries and products. Their science informs the commercial legal work that we carry out on their behalf.
For our Life Science client base, we specialise in providing high-quality practical commercial legal advice through all stages of their business life-cycle which differs greatly from other industries. We appreciate the challenging regulatory environments that our clients operate in. We are happy to invest time in our clients and are committed to helping their business thrive.
Some examples of the work which we regularly conduct for our clients include:
We advise on the correct corporate structures for our clients’ businesses based on their products/services, exit points, funding requirements and business plans.
Technology licensing agreements often form the cornerstone of a Life Science business. We have developed expertise in negotiating and drafting these Agreements. We ensure that they have a clean I.P. chain for the sale and distribution of their products and provide them with confidence that their business is an investable proposition or suitable for acquisition.
The relationship between physician and industry has always been fundamental in ensuring that novel life science products benefit patients. When formalising arrangements clinical leads, HCP's, HCO's and mentors, we ensure that responsibilities (based on the development of the technology) and remuneration (whether equity incentives or otherwise) are clearly and adequately set out to ensure that these key relationships have the best possible chance of being maintained for the benefit of the Company into the future.
In a contract manufacturing scenario for the Life Science sector, we provide detailed and expert advice in the areas of intellectual property ownership and protection as well as quality and regulatory requirements so as to ensure that all parties are aware of their obligations and responsibilities.
We use both Shareholders’ Agreements and Share Subscription and Shareholders’ Agreements to ensure that the relationships between founders and/or investors and the rights of all relevant parties are secured and agreed into the future. For Life Science companies provisions such as ‘non-competes’ and ‘milestones’ and ‘founder vesting' provisions rights require detailed consideration given the particular life-cycles of such companies.
Letters of Intent (LOI’s) or Memorandums of Understanding (MOU’s) are critical for Life Science Companies when dealing with Consultant’s and HCP’s particularly in the research and development stages of novel product development.
In any industry, key considerations for Distribution Agreement include termination provisions, incoterms, credit terms and competition law. For the Life Science Industry, it is increasingly important to also provide for and have expert knowledge in the areas of regulatory obligations, sales history oversight as well as ethics and compliance considerations to ensure that clients are adequately protected.
The relationship between physician and industry has always been fundamental in ensuring that novel life science products benefit patients. When formalising arrangements with clinical leads ,HCP’s, HCO’s and mentors, we ensure that responsibilities (based on the development of the technology) and remuneration (whether equity incentives or otherwise) are clearly and adequately set out to ensure that these key relationships have the best possible chance of being maintained for the benefit of the Company into the future.
We have significant experience in drafting and negotiating multi-party collaborative research agreements for the exploitation and commercialisation of innovative research in the Life Science Sector. We ensure that ownership of background I.P, is clearly defined while reaching agreement is reached with all parties in respect of foreground I.P.
Responsibilities of principal investigators, conduct of trials, use of study data, compliance with relevant laws and regulations, publication restrictions and ownership of intellectual property all play a key role in reaching agreement on a successful clinical trial.
In relation to interaction with HCP’s, Distributors, Clinical Trial participants, regulatory authorities and other key -third parties, we provide expert support and advice in relation to regulatory obligations as well as ethics and compliance considerations at all stages of the business cycle for our clients.
Whether intended for facilitating further research, simple analysis or the creation of further intellectual property, we ensure that all parties to a Material Transfer Agreement have certainty in relation to permitted and non-permitted uses, ownership of intellectual property arising from the transfer, access to results, confidentiality and publication provisions.
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