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MoFo and Bayer Co.Lab Present: ScaleUp Boston

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Please join Morrison Foerster and Bayer Co.Lab for a four-part series exploring the legal aspects of startup entrepreneurship in the life sciences space. Sessions will be held at Bayer’s Co.Lab in Cambridge, providing an ideal environment for early-stage life sciences entrepreneurs to network and ideate.

Please join Morrison Foerster and Bayer Co.Lab for a four-part series exploring the legal aspects of startup entrepreneurship in the life sciences space. Sessions will be held at Bayer’s Co.Lab in Cambridge, providing an ideal environment for early-stage life sciences entrepreneurs to network and ideate.Topics covered will include:<ul dir="ltr"><li dir="ltr">February 20: Most Common Legal and Business Mistakes of Startup Entrepreneurs with Steve Rowles and Andrew Dixon</li><li>March 12: Managing Risk in Life Sciences Licensing and Collaboration Agreements with Katie Brinn, Ryan Bloom, Matt Karlyn, Brigid Bondoc, and Mandi Williams</li><li>April 2: Navigating the IP Landscape with Mike Ward, Meghan Poon, and Jillian Pesin-Fulop</li><li>April 24: Raising Venture Capital Investment with Jim Krenn and Scott Perlov</li></ul>Each session will be followed by a networking reception.MOFORUMProgram participants are also invited to our annual MoForum event, set to take place on May 2 from 8:30 a.m. – 2:00 p.m. at One Dalton in Boston. The free, one-day program brings together leading investors, innovators, and strategists from across the life sciences industry to explore the critical business, legal, and regulatory developments transforming the life sciences ecosystem.Prizes will be awarded to companies attending all five sessions!Space for these events is limited. To register your interest, please use the RSVP button and fill out a short form.<hr>

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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

Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.As co-chair 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

Steve Rowles is Chair of the firm’s San Diego Corporate Group. He has practiced in San Diego for over 25 years and has a wealth of experience as corporate counsel to public and private companies, and the venture capital and private equity funds that invest in those companies.He counsels companies at all stages in their life cycles. He distinguishes himself by achieving successful outcomes for clients utilizing best in class negotiating skills and creative and strategic thinking. He has been instrumental in starting, building and exiting numerous emerging growth companies in a broad range of industries including biotech, medical devices, digital health, diagnostics, healthcare services, clean technology and renewable energy, cybersecurity, fintech, agtech, software, 5G, semiconductors, telecommunications, e-commerce, new media and social networking.Steve has served as lead counsel on myriad mergers and acquisitions and securities transactions, including public offerings aggregating in excess of $2 billion in proceeds and over 100 acquisition transactions.Steve serves as general counsel and handles ’34 Act compliance, public securities offerings, and corporate governance counseling for a substantial number of public companies.Steve is adept at handling venture capital financings for both companies and investors. His expertise in partnership and limited liability company matters has given him substantial experience in fund formation, joint ventures, and other strategic partnering transactions.Steve was a member of Phi Beta Kappa at Northwestern University and was elected to the Order of the Coif at Boalt Hall School of Law.Steve is active on behalf of Children’s Hospital and serves on the Board of Directors for both EvoNexus San Diego and the Jacobs Cushman San Diego Food Bank. Steve is an avid golfer, a voracious reader, and a family man.<h4>Representative Transactions</h4><h5>M&A</h5><ul><li>Represented ACEA Biosciences, Inc. in its $250 million acquisition by Agilent Technologies Inc. (NYSE: A)</li><li>Represented Acon Laboratories in its two complex cross-border acquisitions by Inverness Medical Innovations, Inc. totaling $375 million</li><li>Represented Adicet Bio, a biopharmaceutical company focused on the development of novel off-the-shelf universal immune cell therapies, in its announced merger with a wholly-owned subsidiary of resTORbio (NASDAQ: TORC) to create a combined publicly-traded biotechnology company</li><li>Represented Alaska Energy & Resources Company in its $170 million acquisition by Avista Corp. (NYSE: AVA)</li><li>Represented Astute Medical, a medical diagnostic company focused on high-risk medical conditions and diseases, in its $90 million sale to bioMérieux (EPA: BIM)</li><li>Represented Biotix, a private equity-backed developer and manufacturer of laboratory consumables and liquid handling solutions, in its sale to Mettler-Toledo (NYSE: MTD) for an undisclosed sum</li><li>Represented Biotix in its cross-border sale of PML Microbiologics to bioMérieux (EPA: BIM) for $30,000,000</li><li>Represented Clean Energy Fuels (NASDAQ: CLNE) in its sale of BAF Technologies, Inc. to Westport Innovations Inc. for $30 million</li><li>Represented Clean-Energy Fuels (NASDAQ: CLNE), a leading provider of natural gas fuel for transportation in North America, in the $155 million sale of its renewable gas business to BP p.l.c, a British multinational oil and gas company.</li><li>Represented Clean Energy Fuels (NASDAQ: CLNE), this provider of natural gas as an alternative fuel for vehicle fleets, in its sale for up to $180 million of components of its renewable natural gas business to BP (NYSE: BP</li><li>Represented Cogent, Inc. (NASDAQ: COGT) in its $943 million acquisition by 3M Company</li><li>Represented Compex Legal Services, Inc., one of the largest litigation and discovery support services firms in the nation, in its sale to Windjammer Capital, LP for cash and an earnout totaling approximately $230 million</li><li>Represented Deere & Company (NYSE: DE) in its acquisition of Precision Planting and certain South American operations for $190,000,000 from Monsanto (NYSE: MON and a contemporaneous multi-year precision ag collaboration with Monsanto and the Climate Corporation as well as in related divestiture transactions</li><li>Represented Deere & Company (NYSE: DE) in its acquisition of T-Systems for an undisclosed sum</li><li>Represented Live Nation, Inc. in its $354 million acquisition of the House of Blues</li><li>Represented MedfusionRx and certain affiliated entities in their sale to SXC Health Solutions for $100,000,000 plus undisclosed earnout payments</li><li>Represented Mentor Corporation in its $1.12 billion merger with Johnson & Johnson</li><li>Represented MTY Food Group Inc. in its successful tender offer for the shares of Papa Murphy’s Holdings, Inc. (NASDAQ: FRSH) in a transaction valued at $190 million</li><li>Represented Paladin Technologies Inc. in its merger with TekWorks Inc.</li><li>Advised Scoperta, an innovative solution provider in advanced materials development, in its acquisition by Oerlikon Group, one of the world's leading high-tech industrial groups.</li></ul><h5>Venture Capital</h5><ul><li>Represented ACEA Biosciences Inc., a developer of cell analysis instrumentation technologies, in a $30 million Series E Preferred Stock financing</li><li>Represented ACEA Therapeutics, Inc., a pharmaceutical company developing small molecule candidates for lung cancer and other indications, in its $20 million convertible note financing</li><li>Represented Adicet Bio in its $51,000,000 Series A Preferred Stock financing with OrbiMed, Novartis, and Pontifax and its $80,000,000 Series B Preferred Stock financing with Regeneron, Johnson & Johnson Innovation, KB Investment, Samsung Venture Investment, and prior investors</li><li>Represented Astute Medical, a medical diagnostic company focused on high-risk medical conditions and diseases in over $200 million of equity and debt financings</li><li>Represented Biotix in a restructuring of its $80,000,000 Series A Preferred Stock financing and its $6,000,000 Series B Preferred Stock financing with Ferrer Freeman and Grotech Ventures</li><li>Represented Cellics Therapeutics, Inc., developer of nanosponges with nanoparticle cores coated with red or white blood cell membranes which can be used to absorb a wide range of toxins, in preferred stock financings exceeding $30 million</li><li>Represented Cello Therapeutics, Inc., which uses nanosponge technology as a delivery mechanism for cancer therapeutics, in its $4.2 million Series A-2 financing, bringing its total Series A funds raised to $8 million</li><li>Represented ColorTokens, Inc., a leading cybersecurity company, in its $30 million convertible note financing and preferred stock financings exceeding $100 million</li><li>Represented Clean Energy Fuels Corp. (NASDAQ: CLNE) in over $100 million in investments in NG Advantage LLC</li><li>Represented Curology, Inc., a leading telemedicine provider of dermatology services and prescriptions, in over $60 million of preferred stock financings</li><li>Represented Curology, Inc. in its $30 million Series D preferred stock financing led by Institutional Venture Partners and Anthos Partners. We also represented Curology in a concurrent $11o million private tender offer in which IVP, Anthos, ACME Ventures and TriplePoint Capital purchased shares of common and preferred stock from existing shareholders</li><li>Represented Enterprise Partners in a $7,000,000 Series A-1 Preferred Stock financing by Enviance</li><li>Represented Eolas Therapeutics Inc., a start-up life sciences company in connection with a milestone based licensing transaction with AstraZeneca Inc. with upfront and contingent proceeds potentially in excess of $140 million</li><li>Represented Coupang LLC, a leading e-commerce company in Korea, in three preferred unit financings aggregating $500 million</li><li>Represented Geneos Therapeutics, Inc., a leader in the field of personalized cancer immunotherapy, in $22 million preferred stock financings</li><li>Represented Greenoaks Capital Partners, this entity and its affiliates as investors in over $100 million in equity financings, debt financings, and secondary transactions, including Coupang and several other prominent e-commerce companies</li><li>Represented Ignyta in its $500,000 Series A Preferred Stock financing and its $5,500,000 Series B Preferred Stock financing with City Hill Ventures</li><li>Represented Inertia Systems, Inc., a fast-growing provider of construction management, SAAS software solutions, in its $3.5 million convertible note financing led by Signia Ventures, as well as a $2.5 million extension of such note financing, for an aggregate of approximately $6 million in proceeds</li><li>Represented Netly, LLC, developer of last mile fiber optic networks, in its debt and equity financing led by Ubiquity Partners LLC, with an initial closing of $40 million with an aggregate maximum raise of $250 million</li><li>Represented Obsidian Sensors, Inc., a thermal imaging and sensor company, in its $25 million Series A financings</li><li>Represented The Pill Club Holdings, Inc., a digital health provider of birth control pills, in over $60 million of preferred stock financings</li><li>Represented Rakuten Medical, this biotechnology company developing a new class of precision targeted oncologic drugs, in over $470 million of equity financings</li><li>Represented VoloAgri Group, an agriculture technology company known for seed genetics, in over $150 million of preferred stock financings</li><li>Represented Xilio Therapeutics, Inc., an immunology company, it is $30 million Series A financing</li><li>Represented a lead investor in a $50 million Series D financing in Retrotope, Inc., a developer of a medical platform to treat degenerative diseases</li></ul><h5>Capital Markets</h5><ul><li>Represented Banc of America Securities, Lehman, Thomas Weisel Partners, and William Blair as underwriters in a $82,000,000 initial public offering by Nuvasive</li><li>Represented Cardium Therapeutics in its $20,000,000 PIPE financing and $10,000,000 credit facility</li><li>Represented Clean Energy Fuels (NASDAQ: CLNE) in its $110 million at-the-market offering</li><li>Represented Clean Energy Fuels (NASDAQ: CLNE) in a 144A offering of Convertible Senior Notes in the aggregate principal amount of $250 million</li><li>Represented Clean Energy Fuels (NASDAQ: CLNE) in debt financing transactions with proceeds in excess of $500 million</li><li>Represented Digirad in its $66,000,000 initial public offering with Merrill Lynch, JP Morgan, Banc of America Securities, and William Blair as underwriters</li><li>Represented Fulgent Genetics, Inc. (NASDAQ: FLGT) in its $43.5 million initial public offering</li><li>Represented Harrow Health, Inc. (NASDAQ: HROW) in its $14 million initial underwritten public offering</li><li>Represented Ignyta in its going-public transaction through a reverse merger with a public company and its contemporaneous $47,000,000 PIPE financing with Landenburg Thalman as placement agent and its subsequent $7,000,000 PIPE financing with National Securities Corporation as placement agent</li><li>Represented Inovio Pharmaceuticals, Inc. in a $30 million registered direct offering</li><li>Represented OncoSec Medical Incorporated (NASDAQ: ONCS) in a registered direct offerings aggregating in excess $80 million</li><li>Represented RxElite in its $30,000,000 PIPE financing</li><li>Represented Santarus in its $62,000,000 initial public offering with Cowen, UBS, Thomas Weisel Partners, and RBC Capital Markets as underwriters</li></ul>

Steve Rowles

Jim Krenn is a corporate partner and co-chair of the firm’s Emerging Companies + Venture Capital Group. Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.Jim advises clients on private and public acquisitions on both the buy-side and sell-side across numerous transaction structures, including equity purchases, asset purchases, mergers, acquisitions, divestitures, cross-border transactions, and auctions. He has represented buyers and sellers in acquisitions and divestitures ranging from the low millions to over $1 billion.Jim counsels emerging and established life sciences and technology companies in equity financings and general corporate matters, and angel, corporate, and venture capital investors in investments in such companies. He has represented clients in hundreds of venture capital financings ranging from seed rounds to $100 million-plus later-stage rounds.In addition, Jim represents public companies in public offerings, other capital markets transactions, and SEC reporting and compliance matters, and advises boards of directors on corporate governance issues.Jim is member of the firm’s Life Sciences + Healthcare Group leadership team and Artificial Intelligence steering committee and serves on the Board of Directors of the San Diego Entrepreneurs Exchange.<h4 dir="ltr">Mergers and Acquisitions</h4><ul dir="ltr"><li dir="ltr">ACEA Biosciences, a medical instruments company, in its sale to Agilent Technologies (NYSE: A) for $250 million.</li><li>Adicet Bio (Nasdaq: ACET), a biopharmaceutical company, in its merger with a wholly owned subsidiary of resTORbio (Nasdaq: TORC) to create a combined publicly traded biotechnology company.</li><li>Alaska Energy & Resources Company, a parent company of a regulated electric utility in Alaska, in its $170 million sale to Avista (NYSE: AVA).</li><li>Astute Medical, a medical diagnostic company, in its $90 million sale to bioMérieux (EPA: BIM).</li><li>B. Riley Financial (Nasdaq: RILY), a diversified financial services company, in its $53 million private placement and merger with investment banking firm B. Riley & Co.</li><li>Biotix, a private equity-backed developer and manufacturer of laboratory consumables and liquid handling solutions, in its sale to Mettler-Toledo (NYSE: MTD).</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple acquisitions.</li><li>Clean Energy Fuels (Nasdaq: CLNE), a provider of natural gas as an alternative fuel for vehicle fleets, in its sale for up to $180 million of components of its renewable natural gas business to BP (NYSE: BP).</li><li>Cogent (Nasdaq: COGT), a biometric identification solutions provider, in its $943 million sale to 3M (NYSE: MMM).</li><li>Deere & Company (NYSE: DE), an agricultural, construction, and forestry machinery corporation, in its planned acquisition of the precision planting unit of Monsanto (NYSE: MON).</li><li>Dosatron International, a distributor of water-powered dosing pumps and systems, in connection with its sale to Ingersoll Rand (NYSE:IR).</li><li>Gillco, a leading specialty ingredient provider, in its sale to Azelis (BR: AZE).</li><li>Mentor (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, in its $1.12 billion sale to Johnson & Johnson (NYSE: JNJ).</li><li>Mitchell International, a developer of smart technology solutions, in its acquisition of Cogent Works.</li><li>MyChem, a provider of ultra-pure nucleotides, in connection with its sale to Maravai (NASDAQ: MRVI) for $240 million at closing with potential additional consideration.</li><li>Protomer Technologies, a biotechnology company, in its sale to Eli Lilly and Company (NYSE: LLY) with a potential value of over $1 billion with successful achievement of future development and commercial milestones.</li><li>Rakuten Medical, a biotechnology and medical device company, in its acquisition of Medlight SA and its acquisition of key assets and manufacturing technology from Li-Cor Biosciences.</li><li>Safebuilt Insurance Services, a managing general agent and insurance technology company, in its sale to Integrated Specialty Coverages.</li><li>Sequlite Genomics, a DNA sequencing firm, in connection with its sale to Fapon Biotech, a diagnostic technology company.</li><li>Tendo, a digital health software company, in its acquisition of MDsave, a healthcare marketplace company.</li><li>Wavestream, a provider of high-power solid-state amplifiers, in its $137 million sale to Spacenet, a subsidiary of Gilat Satellite Networks (Nasdaq: GILT).</li></ul><h4 dir="ltr">﻿Venture Financings</h4><ul><li dir="ltr">9amHealth, a provider of virtual diabetes care, in its $4 million Series Seed financing and $16 million Series A financing.</li><li>ACEA Biosciences, a developer of cell analysis instrumentation technologies, in its $30 million Series E Preferred Stock financing.</li><li>Adicet Bio, a biopharmaceutical company, in its Series A financing of up to $51 million, and $80 million Series B financing.</li><li>Astute Medical, a medical diagnostic company focused on high-risk medical conditions and diseases, in over $200 million of equity and debt financings.</li><li>Bidra as an investor in multiple equity financings.</li><li>Biolumic, an agtech company, in its $13.5 million Series B financing.</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple equity and debt financings.</li><li>Carlsmed, a medical device and artificial intelligence company, in its $10 million Series A financing, $30 million Series B financing and $52.5 million Series C financing.</li><li>Crinetics as a strategic investor in Radionetics Oncology’s $52.5 million Series A financing.</li><li>Forward Ventures as an investor in multiple equity financings, convertible debt financings, and M&A transactions.</li><li>Foxen, a provider of financial technology solutions for the real estate industry, in its $44 million Series A financing.</li><li>Greenoaks Capital Partners and its affiliates as investors in multiple equity financings, debt financings, and secondary transactions.</li><li>GroupSolver, an artificial intelligence market research platform, in multiple preferred stock financings.</li><li>Hume.ai, an artificial intelligence company, in multiple preferred stock financings.</li><li>Oak Investment Partners as an investor in multiple preferred stock financings.</li><li>OrbiMed as an investor in multiple equity financings, debt financings, and M&A transactions.</li><li>Petuum, an artificial intelligence and machine learning software infrastructure provider, in its $93 million Series B financing.</li><li>Pi Health, an AI-enabled health technology and clinical research company, in its spin-out from BeiGene, Ltd. and $35 million Series A financing.</li><li>RA Capital as an investor in multiple equity financings.</li><li>Rakuten Medical, a biotechnology and medical device company, in over $730 million of debt and equity financings.</li><li>Softbank affiliates as investors in multiple equity financings.</li><li>Solarflare Communications, a software and hardware company, in over $200 million of equity and debt financings.</li><li>VoloAgri, an agriculture technology company focused on seed genetics, in over $150 million of equity financings.</li><li>Western Digital Capital as an investor in multiple preferred stock financings.</li></ul>

Jim Krenn

Co-Chair of Emerging Companies + Venture Capital Practice

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

Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

Meghan Poon

Jillian brings over a decade of experience in patent prosecution and strategy to her practice. Her practice focuses on patent preparation and prosecution, patent portfolio management, and patent due diligence for life sciences and biotech companies in a wide array of fields, including biologics, pharmaceuticals, cell therapy, cancer therapeutics, personalized medicine, neurodegenerative disease, biofuels, and agricultural biotechnology. She has experience developing and managing U.S. and worldwide patent portfolios, developing global patent strategies, performing due diligence analyses, filing Patent Term Extension applications, and providing strategic advice to align patent strategy with business goals. Jillian also assists clients in technology transaction matters, including licenses and collaborations for development and commercialization.Dr. Pesin-Fulop received her J.D. from the University of California, Berkeley, School of Law, where she received the Law and Technology Certificate and earned the Jurisprudence Award in copyright law. Before attending law school, Dr. Pesin-Fulop was a scientific analyst and patent agent with the firm.Dr. Pesin-Fulop received her Ph.D. in biology from the Massachusetts Institute of Technology, where she was a recipient of a National Science Foundation Graduate Research Fellowship. She graduated magna cum laude from Williams College with a B.A. in biology and Russian and was elected to Phi Beta Kappa.

Jillian Pesin-Fulop

Of Counsel

Andrew Dixon is a corporate Of Counsel in the firm's San Diego office.Andrew represents clients across a wide range of Corporate matters, including general corporate, transactional and securities matters, mergers and acquisitions, and public and private offerings. Andrew’s representation of companies spans the entire corporate life-cycle, from formation to exit, and a diversity of industries and includes clients of all sizes, ranging from a single founder to large public companies.Andrew received his J.D. with honors from The University of Chicago Law School, where he was a John M. Olin Student Fellow in Law and Economics. He also participated in The University of Chicago Corporate Lab: Transactional Clinic and was a member of The Federalist Society. Andrew received his B.A. magna cum laude in history from the University of Dallas, where he was a recipient of the Fr. Louis J. Lekai award.

Andrew Dixon

Robin Gimm is an associate in the San Diego office of Morrison & Foerster and a member of the firm’s Emerging Companies + Venture Capital Group. Before joining Morrison & Foerster, Robin worked as a corporate associate representing emerging companies though every stage of their lifecycle and venture capital funds with their investments. Her work with emerging companies focuses on corporate formation, equity and debt financings, and general corporate advising, including counseling boards of directors on governance matters. Robin also advises venture capital funds in connection with their investments in emerging companies across a broad range of industries.Robin received her J.D. from Columbia Law School, where she was a James Kent Scholar and Harlan Fiske Stone Scholar. While attending Columbia, she served as the Treasurer for the Columbia Law Review and the Caravan Chair for the Society for Immigrant and Refugee Rights. Robin earned her B.A., magna cum laude, in Political Science from Williams College.

MoFo and Bayer Co.Lab Present: ScaleUp Boston

20 Feb 2024 - 02 May 2024