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Unpacking the Science and Legal Considerations of COVID-19 Testing

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In this episode Mike Ward, head of the firm’s Life Sciences group, discusses the unique aspects of the health crisis on the science, with Jim Mullen; the regula

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Unpacking the Science and Legal Considerations of COVID-19 Testing

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Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.As head of the Patent Group, Mike manages a team that includes 80+ Ph.D.s and 100+ attorneys and others with advanced scientific degrees in life sciences and related engineering disciplines. From small molecules and antibodies to gene editing, artificial intelligence, and machine learning, MoFo has deep experience protecting some of the most important innovations in the life sciences and food and agriculture sectors.Life SciencesFor his work across the life sciences sector, Mike was named San Francisco Biotechnology Lawyer of the Year by Best Lawyers in America in 2020 and is recommended for his patent strategy and prosecution practice in LMG Life Sciences. He also led the team that was named 2022 Patent Management and Strategy Firm of the Year at the 2022 LMG Life Sciences Americas Awards.Food + AgricultureRecognized as “one of the world’s foremost plant and agriculture IP lawyers,” Mike manages a wide range of intellectual property issues related to plants and plant products. He and his team advise clients on plant and plant utility patents; licensing agreements for plant IP; litigation in U.S. state and federal court and before the International Trade Commission; and regulatory approvals from the USDA, FDA, and EPA for gene edited and genetically engineered plants.Patent Strategy + ProsecutionMike is a Legal 500 US Hall of Fame lawyer for patent prosecution and is consistently named one of the leading IP lawyers by Managing Intellectual Property, Chambers USA and Chambers Global, and IAM Patent 1000.Mike works closely with many clients to develop and manage their patent portfolios. He helps clients identify, monitor, and assess the infringement risks of third-party patents. He also assists clients in preparing both offensive and defensive patent portfolios, with a particular emphasis on drafting patent applications that will be utilized in licensing and in litigation efforts.IP Due DiligenceFor venture capitalists seeking to invest in early- and mid-stage companies, underwriters involved in IPOs, and companies seeking to acquire or merge with other companies, Mike has managed extensive IP diligence. His work includes assessment of the strengths and weaknesses of patent portfolios, evaluation of freedom to operate issues, and strategic recommendations for maximizing the value of patent portfolios going forward.Mike also works closely with the IP Litigation Group on various litigation matters including patent interferences to determine the first-to-invent and patent re-examination work and actively participates in both mediation and arbitration proceedings on behalf of clients in the life sciences and food and agriculture areas.He is a frequent lecturer and speaker. Among numerous speaking engagements, Mike is the IP instructor at the UC Davis Licensing Academy and founded Morrison Foerster’s annual Harvard Biotechnology Club Fall Patent Law Course.Mike holds a Ph.D. in plant physiology (biochemistry) and an M.S. in agronomy from the University of California, Davis; a B.S. in biology from the University of California, Berkeley; and a J.D. from Golden Gate University School of Law. He was a post-doctoral fellow in plant molecular biology at the Harvard Medical School and the Department of Molecular Biology at Massachusetts General Hospital, where he worked on the Arabidopsis genome project.

Michael Ward

Co-Chair of Life Sciences + Healthcare

Matthew A. 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.

Matthew Karlyn

Partner

<div class="videoWrapper"><iframe class="sticky-video" allowfullscreen="1" allow="autoplay; encrypted-media" frameborder="0" src="https://www.youtube-nocookie.com/embed/BA6FGenan5g?rel=0" title="Meet MoFo New York Litigation Partner Kristen Mathews" title="iframe"></iframe></div>Kristen is a partner in Morrison Foerster’s Global Privacy + Data Security Group. For more than 20 years, Kristen’s practice has focused on advising clients on the full spectrum of the most complex privacy and cybersecurity issues, including compliance with U.S. federal and state privacy laws and European data protection laws, contracts, cybersecurity preparedness, and data breach incident response. Most recently, Kristen has developed an expertise in privacy issues with the development and use of artificial intelligence, and in the ethical ramifications of the use of AI and other new technologies. An early leader in the privacy sphere, Kristen has developed comprehensive knowledge and long-term perspective, cultivated a client base across a broad range of industries, and established herself as one of the top lawyers in her field.The Legal 500 has recognized Kristen for her singular work, inducting her into its Hall of Fame in the category of Cyber Law. In the words of her clients, “[Kristen is] by far the most knowledgeable data privacy and data protection lawyer one can work with,” and they cite her for demonstrating “leading ‘expertise’ in the full spectrum of privacy, data protection, and cybersecurity law,” (The Legal 500 2022). Clients also note her global reach and high caliber work: “[Kristen] helps clients to adapt their policies to different jurisdictions with widely varying data protection laws”; they also regard her for “offering tailored solutions based on client needs,” (The Legal 500 2022) and conclude “Kristen Mathews stands out as one of the most skilled and competent lawyers we have ever worked with. She is unmatched among any cyber law lawyer and collaborates deftly across teams” (The Legal 500 2023). Since 2010, Chambers and Partners has consistently ranked Kristen for her outstanding client service and extensive knowledge of the data privacy and cybersecurity space. She has been accredited by the International Association of Privacy Professionals (IAPP) as a certified information privacy professional (CIPP) since 2005.Clients across the technology, financial, retail, consumer goods and services, healthcare, insurance, media, education, auto, utilities, sports, and hospitality sectors seek Kristen’s counsel for their most complex privacy and cybersecurity matters. Kristen’s privacy and cybersecurity experience includes guiding clients on compliance with data privacy laws, such as the General Data Protection Regulation (GDPR), and United States privacy laws, such as the California Consumer Privacy Act (CCPA) and similar laws in other states; protecting data in critical transactional matters such as M&A deals and important commercial services agreements; and preventing, preparing for, and responding to cybersecurity breaches. Kristen also advises leaders in the field of AI on cutting-edge projects involving licensing data to train AI, collecting consumer consents for the use of their data to train AI as well as to make decisions that affect their lives using AI, and compliance with emerging laws and other complex issues regarding AI. Kristen is on the board of a nonprofit organization whose mission is to promulgate ethical guidelines for the use of AI by companies.Kristen also assists financial services and insurance businesses to build and mature their cybersecurity programs, and provides counsel on direct marketing via text, voice, and email and on online, telematics, employee, and workplace privacy. Additionally, Kristen was instrumental in establishing the <a href="/mofo-privacy-minute" target="_self">A MoFo Privacy Minute Series</a>, a collection of easy-to-digest Q&As on key privacy issues. She is also a member of MoFo’s global Environmental, Social, and Governance (ESG) steering committee.A few examples of Kristen’s recent work include the following:<ul><li>Assisted a global merchandise business in investigating, responding to, and defending claims brought in relation to a cybersecurity data breach that affected a large volume of consumers and other businesses.</li><li>Assisted dozens of consumer businesses in determining and implementing a practical plan of action to comply with the CCPA and similar state privacy laws.</li><li>Assisted over 100 businesses in varying industries in becoming compliant with Europe’s GDPR.</li><li>Advised AI start-up company regarding the collection of consent from individuals to collect their personal information to train an artificial intelligence product, and regarding their license of training data and AI models to other businesses.</li><li>Negotiated data license agreement with hospital system to apply AI that identifies opportunities for improvements in medical diagnosis and treatments.</li></ul>Alongside her busy practice, Kristen uses her privacy expertise to provide pro bono services. She has worked with nonprofits that help individuals and families improve their economic and social well-being and has advised charities on incident response following cyber and ransomware attacks.Kristen continues to be at the forefront of developments in privacy and cybersecurity as ever-changing issues affect businesses around the world.