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Non-Lab Diagnostics: FDA Regulatory Considerations

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The advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. 

We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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FDA REGULATORY ISSUESThe advent of the COVID-19 rapid antigen test launched at-home diagnostics to the forefront of conversation in the life sciences industry. Many believe this is only the beginning. As the share of telehealth services increases, drawing interest away from traditional healthcare services models, startups and established companies alike are positioning themselves to take advantage of the growing market for technologies and products that enable non-lab-based diagnostics capable of being purchased without a prescription and conducted entirely at home.[2] MoFo’s FDA Regulatory team has described the top three issues developers of these tests should consider.Read the full <a href="https://lifesciences.mofo.com/topics/non-lab-diagnostics-fda-regulatory-considerations" target="_blank">blog post</a>.

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Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group, advising innovative and mission-driven life sciences and technology companies.Matt has more than a decade of experience in structuring, drafting, negotiating, and executing strategic transactions where intellectual property (IP), technology, data, and information assets drive the deal. Matt is passionate about and focuses his practice on assisting innovative companies in industries where the betterment of people’s lives and the world is in view, including in the broader life sciences and technology areas, such as:<ul><li>Pharmaceuticals and biotechnology (including small molecule pharmaceuticals, biologics, nanotherapeutics, drug discovery, antibodies, cell and gene therapy, CRISPR and other gene editing technologies, drug delivery, immunology, and oncology); and</li></ul><ul><li>Medtech and healthtech (including medical devices, digital health, and other forms of software and hardware in diagnostic and therapeutic applications); and</li><li>Food and agriculture (including in plants and crop sciences, agriculture and farming, alternative proteins, animal and plant production, and food products and consumer goods); and</li><li>Cleantech (including renewable energy, biofuels, plastic recycling and carbon capture).</li></ul>Outside of his life sciences practice, Matt counsels clients in a variety of industries, including Internet of things (IoT), artificial intelligence (AI) and machine learning (ML), wireless standards, autonomous vehicles, semiconductor devices, distributed software, open-source software, and software as a service. Matt has solid experience advising startups in all aspects of IP hygiene, including invention assignment agreements and use of open-source software, as well as complex patent transactions involving standard essential patents (SEPs). Matt leverages his previous experience in patent prosecution and IP litigation to provide a holistic perspective and overall business strategy to his client’s transactions.He advises clients in connection with:<ul><li>Commercial contracts at all stages of technology and product development, including strategic alliances and collaborations, asset sale and purchase agreements, research and development agreements, supply, manufacturing, and distribution agreements, clinical trial agreements, service agreements, and material transfer agreements.</li><li>Patent and technology license agreements in both industry-to-industry and academic-to-industry settings.</li><li>IP and commercial contract matters that arise in connection with larger corporate transactions such as mergers and acquisitions and venture capital investments.</li></ul>In Matt’s past experience as a patent prosecutor and IP litigator, he handled cases involving patent infringement and invalidity, copyright infringement, and trade secret misappropriation. He also draws on his technical knowledge that he developed in his undergraduate work at University of California, Berkeley, his graduate work at the California Institute of Technology, and his hobbyist scientific pursuits, including in physics, software, microwave instrumentation, and optics.Matt also maintains an active pro bono practice representing small business owners and nonprofits in their commercial agreements. Recently, he assisted a low-income entrepreneur in drafting her customer-facing service agreements.<h4>Representative Matters</h4><h5>Pharmaceuticals and Biotechnology</h5><ul><li> Represent multi-national pharmaceutical company in its manufacturing agreements.</li></ul><ul><li>Represent public mRNA technology company in its patent licensing strategy and evaluation agreements.</li><li>Represented Eton Pharmaceuticals, Inc. in connection with its asset sale of several of its branded and generic injectable products to Dr. Reddy’s Laboratories.</li><li>Represented public pharmaceutical company in its purchase of three product lines from a Fortune 500 public pharmaceutical company.</li><li>Represented public pharmaceutical company in its sale of three product lines to private equity-backed purchaser.</li><li>Represented public pharmaceutical company in numerous patent and technology asset purchases and sales, exclusive licensing arrangements, commercial alliances, and co-promotion agreements.</li><li>Represented public pharmaceutical company in several patent and technology asset purchases and sales, including its sale of three product lines focused on rare neurological diseases and associated assets to a private purchaser.</li><li>Represented venture-backed pharmaceutical company focused on treating rare diseases in China in several exclusive license and supply agreements.</li><li>Represented U.S. academic institution in numerous patent and technology exclusive licensing agreements, sponsored research agreements, option agreements, and term sheet negotiations.</li><li>Represented nanotherapeutic company in numerous research and collaboration agreements and licensing agreements.</li><li>Represented CRISPR-based company in numerous evaluation agreements, material transfer agreements, and collaboration agreements.</li><li>Represented startup company in its gene modification research agreement templates.</li></ul><h5>Medical Devices and Health Technology</h5><ul><li>Represented medical device startup in its several exclusive patent and technology license agreements with a leading academic institution and its clinical trial agreements.</li><li>Represented digital health company in its collaboration agreement with a global distributor.</li><li>Represented medical device company in its multisite clinical trial agreements.</li><li>Represented public medical device company in its exclusive license and distribution agreement with global medical device distributor.</li><li>Represented medical device incubator in its form technology and service agreements, patent license agreement from an academic institution, and sublicense agreements.</li><li>Represented public medical device company in its patent purchase from an individual physician.</li><li>Represented medical device company in its multi-country distribution agreements.</li></ul><h5>Food and AgTech</h5><ul><li>Represent an innovative plant protein startup in all forms of its commercial contracts and licensing, including its university research agreements, grower agreements, evaluation agreements, and material transfer agreements.</li><li>Represent a plant genomics and gene editing company in its strategic alliance with a leading commercial nursery.</li><li>Represent a food storage company in evaluating outbound technology licensing models and its outbound license terms.</li><li>Represent a botanical active ingredient producer in its research collaboration agreement with a botanical ingredient biotechnology company.</li><li>Represent an agtech company in its outbound license of its proprietary gene design platform to a biotechnology company.</li><li>Represent a public agency in its licensing agreements for proprietary fruit varieties.</li><li>Represent an agtech company in all forms of its commercial contracts, including university research agreements, NDAs, material transfer agreements, and evaluation agreements.</li><li>Represent novel infant formula company in its dozens of supply and manufacturing agreements with its ingredient suppliers and formula manufacturers.</li></ul><h5>Clean Technology</h5><ul><li>Represent public carbon credit investing company in its collaboration agreement with air quality monitoring company.</li></ul><ul><li>Represent venture-backed clean technology startup in its international collaboration agreements.</li><li>Represent venture-backed clean technology startup in its technology license and service agreement with international public energy company and other licensees.</li><li>Represent venture-backed clean technology startup in its international collaboration agreements.</li><li>Represent venture-backed clean technology startup in its technology license and service agreement with international public energy company and other licensees.</li></ul><h5>Complex Patent Transactions</h5><ul><li>Represented global public semiconductor company in connection with its patent purchase form agreements.</li><li>Represented global public semiconductor company in its patent license and license-on-transfer agreement with another global public semiconductor company.</li><li>Represented leading wireless technology company in its patent cross-license with another leading wireless technology company.</li><li>Represented leading wireless technology company in its form standard essential patent (SEP) licensing agreements and term sheets.</li></ul><h5>On-Premise Software and SaaS</h5><ul><li>Represented private construction lender in its acquisitions of two real estate technology platforms.</li><li>Represented machine learning and natural language processing software company in its on-premises software and hosted services agreements.</li><li>Represented SaaS company in its services agreement with leading automobile manufacturers.</li><li>Represented artificial intelligence-based warehousing software company in its template software license and services agreement.</li><li>Represented software company in its source code license and services agreement to international software company.</li></ul><h5>Interactive Entertainment</h5><ul><li>Represented publisher in several game development agreements and content licensing agreements.</li><li>Represented developer in its publishing and distribution agreements.</li><li>Advised developer in its renegotiation of its publishing and distribution agreement.</li></ul><h5>Professional Services</h5><ul><li>Represented numerous professional service providers in their template and negotiated services agreements.</li></ul><h5>Venture Capital</h5><ul><li>Represented fitness technology startup in its $5.8 million Series A financing.﻿</li></ul>

Matthew Ferry

Partner

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As a member of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Matt Karlyn has 25 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensing, and technology transactions. His clients range from Fortune 100 companies to start-ups, and he regularly advises companies on matters involving IP commercialization, complex collaboration transactions, licensing initiatives, subscription-based economics, and business transactions related to the procurement, development, commercialization, and use of technology and life sciences products. He has also worked with a number of clients on corporate transactions including mergers and acquisitions, as well as private equity and venture capital financing.Matt is ranked Band 1 by Chambers USA for Intellectual Property: Licensing in Massachusetts. Clients in Chambers describe Matt as: “accessible and engaged, and he is really focused on getting the right answer for us."<h4>Life Sciences</h4>Life sciences clients, including pharmaceutical, medical device, and healthcare companies, rely on Matt for his breadth of knowledge in licensing, collaboration, and commercialization strategies across a wide range of transactions designed to strengthen operations and maximize value. Matt’s clients come from sectors across the global economy and include emerging companies, privately held companies, and many of the world’s biggest brands.Matt has broad experience with commercial transactions and agreements in the life sciences space, including:<ul><li>Intellectual property and technology licenses</li><li>Collaboration and development transactions</li><li>Commercialization agreements</li><li>Supply and manufacturing transactions</li></ul><h4>Technology</h4>Matt regularly advises on the use of technology in business, pricing strategies, and market terms across a wide variety of technology transactions that benefit clients both large and small. He has extensive experience negotiating a wide range of transactions, including:<ul><li>Enterprise resource planning and customer relationship management licensing and implementation transactions</li><li>Cloud-based transactions including software-as-a-services, platform-as-a-service, and infrastructure-as-a-service.</li><li>Software licensing</li><li>Supply chain and procurement deals</li></ul>Additionally, Matt has worked on many of the largest outsourcing transactions in the United States, representing numerous Fortune 100 companies on information technology, business process, finance and accounting, facilities services, and other outsourcing transactions.Matt is a frequent author and speaker on topics pertaining to drafting and negotiating commercial technology, outsourcing, and licensing transactions. He has published over 25 articles (including chapters in two books), given over 175 presentations on licensing, technology, outsourcing, and data security, and is the co-author of A Guide to IT Contracting: Checklists, Tools, and Techniques.Matt is currently co-chair of the Legal and Regulatory policy group at the Massachusetts Biotechnology Council. He served as chair of the New England Chapter of the International Association of Outsourcing Professionals, and served for five years on the board of directors of Julie’s Family Learning Program, a wellness program for mothers and children in South Boston.

Matt Karlyn

Life Sciences + Healthcare

FDA + Healthcare Regulatory and Compliance

IP Due Diligence