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Morrison Foerster Advised CSPC Megalith Biopharmaceutical Co. on Exclusive Licensing Agreement

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Morrison Foerster advised CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited (Stock code: 1093.HK) in connection with an exclusive license agreement with Elevation Oncology, Inc. (NASDAQ: ELEV). Under the terms of the agreement, CSPC Megalith agreed to grant an exclusive license to Elevation Oncology to develop and commercialize SYSA1801, a novel anti-Claudin 18.2 antibody drug conjugate, outside Greater China (including mainland China, Hong Kong, Macau, and Taiwan). 

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Morrison Foerster advised CSPC Megalith Biopharmaceutical Co., Ltd., a subsidiary of CSPC Pharmaceutical Group Limited (Stock code: <a href="https://1093.hk/">1093.HK</a>) in connection with an exclusive license agreement with Elevation Oncology, Inc. (NASDAQ: ELEV). Under the terms of the agreement, CSPC Megalith agreed to grant an exclusive license to Elevation Oncology to develop and commercialize SYSA1801, a novel anti-Claudin 18.2 antibody drug conjugate, outside Greater China (including mainland China, Hong Kong, Macau, and Taiwan). The MoFo deal team was led by Boston Technology Transactions Group and Life Sciences Transactions + Licensing partner Matt Karlyn and associate Mai Zymaris, with assistance from San Francisco senior of counsel Otis Littlefield, San Francisco Technology Transactions Group associate Dr. Gilbert Choi, Boston Technology Transactions Group associate Hannah Koo, and Washington, D.C. FDA Regulatory + Life Sciences Compliance of counsel Brigid Bondoc.  Read the <a href="https://doc.irasia.com/listco/hk/cspc/announcement/a220728.pdf">press release</a> for the transaction.

Morrison Foerster Advised CSPC Megalith Biopharmaceutical Co. on Exclusive Licensing Agreement

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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

Partner

Otis focuses his practice on representing life sciences clients, including biotechnology, pharmaceutical, agricultural biotechnology, and medical device companies.He has deep experience and knowledge in two main areas: patent prosecution strategy and management and intellectual property-related business transactions. He counsels clients in life sciences-related areas for protection of products such as GM organisms and biologicals for therapy, prophylaxis, and industrial applications—antibodies, vaccines and adjuvants, cell-based applications, gene therapy, and diagnostics—that can include high-throughput screening and microarray technologies, bioinformatics, and molecular biology based technologies.His prosecution practice focuses on portfolio strategy development and implementation, management, and evaluation. Otis manages due diligence studies in connection with venture capital, private and public financing, and mergers and acquisitions.In the area of intellectual property-related business transactions, Otis has represented a variety of life sciences companies on a broad range of transactions, including:<li>In- and out-licenses</li><li>Drug discovery and development agreements</li><li>Clinical trial agreements</li><li>Manufacture and supply agreements</li><li>Multi-party consortium and intellectual property agreements</li><li>Joint research and development agreements</li><li>Commercialization agreements</li><li>Strategic joint ventures</li><li>Mergers and acquisitions</li>

Otis Littlefield

Senior Of Counsel

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

Life Sciences + Healthcare

FDA + Healthcare Regulatory and Compliance

Technology Transactions