Life Sciences

Transactional – Securities & Capital Markets

• Representing the underwriters (Cowen, SVB Leerink and Credit Suisse) in the anticipated $150M initial public offering of a biotechnology company
• Represented NexImmune, Inc. in its $126.5M initial public offering underwritten by Barclays, Raymond James, Cantor Fitzgerald and Allen & Company
• Represented Inhibrx, Inc. in its $136.9M initial public offering underwritten by Jefferies LLC, Credit Suisse Securities and Evercore Group
• Represented Viela Bio, Inc. in its $172.6M initial public offering underwritten by Morgan Stanley, Goldman Sachs, Cowen and Guggenheim
• Represented Intra-Cellular Therapies in its $295M public offering underwritten by J.P. Morgan, Leerink, Evercore, Cantor Fitzgerald, Canaccord Genuity and JMP
• Represented G1 Therapeutics, Inc. in its $180M public offering underwritten by J.P. Morgan, Cowen, Needham & Company, Wedbush Securities Inc. and BTIG
• Represented ImmunoGen, Inc. in its $150.7M public offering underwritten by J.P. Morgan, Goldman Sachs & Co. LLC, Cowen, Canaccord Genuity and H.C. Wainwright & Co.
• Represented the underwriters in the $188.5M public offering of Adverum Biotechnologies, Inc. underwritten by SVB Leerink LLC, Goldman Sachs & Co. LLC, Piper Sandler & Co., and Cowen and Company, LLC
• Represented the underwriters in the $492M public offering of Acceleron Pharma Inc. underwritten by JP Morgan Securities, SVB Leerink, Cowen and Company, Barclays, Credit Suisse and Piper Sandler
• Represented the underwriters in the $152M public offering of Mersana Therapeutics underwritten by Cowen and Company, SVB Leerink, Wedbush PacGrow, Baird and H.C. Wainwright & Co.

Transactional – SPACs

• Represented Butterfly Network, Inc. (NYSE: BFLY), an innovative social impact digital health company, in its $1.5B business combination with the SPAC, Longview Acquisition Corp.
• Represented Locust Walk Acquisition Corp. in its business combination with eFFECTOR Therapeutics, Inc. (NASDAQ: EFTR), a biopharmaceutical company
• Represented Vicarious Surgical Inc. (NYSE: RBOT), a next-generation surgical robotics company, in its $1.1B business combination with the SPAC, D8 Holdings Corp.
• Represented Hyperfine, Inc. (NASDAQ:HYPR), a medical device company that created a portable MRI system, in its $580M business combination with Liminal Sciences, Inc. and the SPAC, HealthCor Catalio Acquisition Corp.
• Represented DermTech, Inc. (NASDAQ: DMTK), a biotech company focused on precision dermatology, in its $440M business combination with the SPAC, Constellation Alpha Capital Corp.

Transactional – Mergers & Acquisitions

• Represented Azenta Life Sciences (NASDAQ: AZTA) (formerly Brooks Automation, Inc.), a leading provider of life sciences solutions worldwide, in the sale of its Semiconductor Solutions business to private equity firm Thomas H. Lee Partners, L.P. for $3B in cash
• Represented Viela Bio, Inc. (Nasdaq: VIE), a biotechnology company, in its $3.05B sale to Horizon Therapeutics plc (Nasdaq: HZNP), a specialty and generic drug manufacturing company
• Represented QIAGEN N.V. (NYSE: QGEN), a Germany-based provider of life science and molecular diagnostic solutions, in multiple transactions, including its cross-border acquisition of NeuMoDx Molecular, Inc., a US-based company that designs and develops molecular diagnostic solutions for hospital and clinical reference laboratories, its acquisition of the digital pcr assets of Formulatrix, Inc., its strategic partnership with NeuMoDx Molecular, Inc., its acquisition of Ingenuity Systems, Inc., as well as its acquisition of SA Biosciences Corporation
• Represented Myriad Genetics, Inc. (NASDAQ: MYGN), a molecular diagnostic company, in multiple acquisitions, including its sale of Myriad RBM, Inc., which specializes in contract research services for the pharmaceutical industry, to Q2 Solutions, its acquisition of Counsyl, its acquisition of Assurex Health, as well as its acquisition of Crescendo Bioscience, Inc.
• Represented Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots, in its sale to Abbott (NYSE: ABT)
• Represented Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, in its acquisition of UmanDiagnostics AB, the world’s leading Nf-L antibody supplier
• Represented Censa Pharmaceuticals, Inc., a biopharmaceutical company, in its sale to PTC Therapeutics, Inc. (NASDAQ: PTCT), a global biopharmaceutical company
• Represented Biogen Inc. (NASDAQ: BIIB), a biotechnology company, in the $900M sale of a biologics manufacturing facility to FujiFilm Corporation, a photography and imaging company
• Represented Orgenesis Inc. (NASDAQ: ORGS), in the sale of its stake in its Mastercell Global, Inc. subsidiary to Catalent Pharma Solutions for a total purchase price of $315M, of which Orgenesis received approximately $127M of net proceeds
• Represented FloDesign Sonics, Inc., an acoustic cell processing platform developer for the industrialization of cell and gene therapy manufacturing, in its sale to EMD Millipore Corporation
• Represented Philips Healthcare in connection with dozens of mergers and acquisitions and other strategic transactions in the areas of diagnostic imaging and ultrasound, image-guided therapy, patient care and monitoring solutions, sleep and respiratory care, therapeutic temperature management, healthcare informatics and population health management, and health and wellness

Transactional – Venture Capital

• Represented Cardurion Pharmaceuticals, Inc. in its private investment of up to $300M from Bain Capital Life Sciences and Bain Capital Private Equity
• Investor-side representation in the $25M Series D financing of a cancer therapeutic company led by Matrix Capital Management
• Investor-side representation in the $70M Series B financing of Oncorus, Inc. led by Cowen and Company and Perceptive Life Sciences
• Investor-side representation in the $82.5M Series B financing of Repare, Inc. led by Cowen Healthcare Investments, Orbimed, Redmile, Versant, and MPM Bioventures
• Represented Viela Bio, Inc. in its $75M Series B financing led by HBM Healthcare Investments, Viking Global Investors, Cormorant Asset Management, Terra Magnum Capital Partners, Goldman Sachs, Barer & Son Capital, and Temasek
• Represented Aura Biosciences, Inc. in its $40M Series D financing led by Meicxi Ventures, Arix Bioscience, Lundbeck, Advent Venture Partners, Chiesi Ventures, and Ysios Capital
• Investor-side representation in the $235M Series A financing of AskBio led by Vida Ventures
• Investor-side representation in the $15M Series C-1 financing of SPR Therapeutics led by Sunrise Management Services
• Represented Vedanta Biosciences in its $26.7M Series C preferred stock financing led by the Bill & Melissa Gates Foundation, PureTech Health, Invesco, and Bristol-Myers Squibb
• Investor-side representation in the $40M Series B financing of Cadent Therapeutics, Inc. led by Cowen Healthcare Investments, Atlas Venture, Qiming Venture Partners, Access Industries, Clal Biotechnology Industries, and Novartis Institutes for Biomedical Research
• Represented Black Diamond Therapeutics Inc. in its $85M Series B Preferred financing led by NEA, Versant Ventures, and RA Capital

Patent Litigation and IPRs

• Represented plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and Nissan Chemical Industries, Ltd. in litigation which involved compound, formulation, and polymorph patents directed toward quinoline-type mevalonolactones (or, pitavastatin calcium) relating to the drug product Livalo®. Several of the cases successfully resolved pre-trial, and after a 10-day trial plaintiffs prevailed on all issues in two court decisions against the remaining defendants, Amneal and Apotex. Mintz represents Kowa and Nissan in the appeal filed by Amneal and Apotex in the Federal Circuit. The team also defeated institution of three inter partes reviews filed by generic manufacturer defendants in these cases.
• Defended Enzymatics against claims of trade secrets theft and patent infringement brought by three plaintiffs in a case involving nucleic acid ligands. Resulted in favorable settlement for our client.
• Takeda Chemical Industries Ltd. v. Mylan and Alphapharm; 417 F. Supp. 2d 341, (S.D.N.Y. 2006); aff'd, 492 F.3d 1350 (Fed. Cir. 2007); cert. denied. 552 U.S. 1295 (2008) - Post-KSR case interpreting Supreme Court approach to obviousness and upholding non-obviousness of important pharmaceutical advances.

Regulatory

• Counseled a large clinical diagnostics company on the design and implementation of a tissue banking and outcomes research program, including acquisition of clinical data within regulatory confines to support an outcomes research program.
• Provided strategic counsel to a start-up medical application company that has devised a method to detect mild cognitive impairment as a precursor to more significant cognitive diseases.
• Advised on legal and regulatory issues surrounding market launch of a software solution to gather patient data from peripheral devices and coordinate a communication and management platform with their physician, including licensing arrangements, clinical study agreements, and quality and supply agreements.
• Counseled a pharmaceutical company on the post-mortem acquisition of tissue samples and associated clinical data to support its research program.
• Counseled a publically traded medical device company on risk management advice and helped them manage multiple significant adverse events following suspension of trial by the FDA.
• Participated in marketing and labeling pre-launch team, working side by side with biological client team to craft marketing messages and product labeling for product launch.
• Advised a medical device company on possible FDA regulation of treatment of mobile wireless applications as medical devices.
• Represent a national IVF clinic and management provider in drug delivery, pharmacy relationships, and delivery of care issues.
• Advised the Institutional Animal Care and Use Committee of a large, academic medical center on a variety of preclinical studies, including studies involving a primate model.
• Guided a medical device manufacturer through multiple FDA inspections and developed effective and sustainable corrective actions to address deficiencies and avoid focused FDA enforcement.
• Advise innovative drug development client on regulatory strategy following Phase II clinical study data analysis.
• Conducted a regulatory assessment and classification of software product used to support monitoring and management of patients with chronic obstructive pulmonary disorder.
• Assisted a private company in the establishment of a stem cell research oversight committee to support its stem cell research program, in compliance with state and federal standards.
• Serve as general counsel to a 501(c)(3) organization engaged in research and education in peripheral vascular disease, including advice on the initial structure and ongoing management of its entire research program; drafting, reviewing, and negotiating agreements and consent forms; and assisting with audits and other inquiries.

Litigation

• Represented a global pharmaceutical manufacturer in a highly publicized antitrust MDL class action antitrust litigation, which was the first alleged pharmaceutical “pay-for-delay” case to go to trial since the Supreme Court articulated a new controlling legal standard in its 2013 decision in FTC v. Actavis. Case settled on favorable terms.
• Served as counsel for a global pharmaceutical company in a lawsuit alleging that a group of pharmaceutical manufacturers conspired to overstate the average wholesale price (“AWP”) for prescription drugs covered by the Medicare program. Plaintiffs advanced claims under §§ 1 and 2 of the Sherman Act and the RICO Act. Through our advocacy, we convinced plaintiffs to drop their claims against our client in their consolidated amended complaint, thereby concluding involvement in the matter without any liability.
• Won an arbitration award, following over a week of trial, completely dismissing all claims of material breach of a collaboration agreement that would have deprived our client, an international biotech company, of its fifty percent interest in a billion-dollar drug.
• Served as Lead California Counsel and on National Trial Team for large pharmaceutical client in massive products liability litigation involving company’s voluntary withdrawal of blockbuster nonsteroidal anti-inflammatory drug alleged to have caused heart attack, strokes and other injuries in thousands of users from the market. Participated in several bellwether trials that went to verdict in NJ and CA.
• Served for more than two decades as national products liability and lead trial counsel for national medical device manufacturer with responsibility for handling, supervising, managing and/or directing the defense of their significant products liability matters and providing general advice regarding risk management, CAPA, recalls, pre-litigation strategy, litigation prevention and regulatory issues relating to their various divisions and product lines. Also supervised local counsel throughout the country and participated in trials in multiple venues.
• Defended a public pharmaceutical company and its officers against 10(b) claims and Section 11 claims arising out of a secondary public offering and successfully obtained a motion to dismiss these claims on behalf of our client.
• Represented Vertex Pharmaceuticals, Inc. in a decision crystalizing the standard required to plead scienter in securities fraud cases, the First Circuit affirmed the dismissal of a securities class action complaint filed against Vertex and the company’s senior executives by Local No. 8 IBEW Retirement Plan and Trust.  This decision ends four years of litigation defending against plaintiff’s false and unfounded allegations that Vertex’s disclosures regarding the results of clinical trials assessing the safety and efficacy of the company’s combination drug therapy for the treatment of patients with cystic fibrosis violated the federal securities laws. We successfully rebuffed plaintiffs twice in the District Court, ultimately securing victory in the First Circuit.
• Served as national coordinating and trial counsel for large pharmaceutical company for litigation involving use of synthetic hormones and claims it acted as a trans-placental carcinogen and teratogen and was associated with the development of gynecologic cancers and birth defects in claimants exposed in utero. Tried multiple cases to verdict in CT, PA, CA and other jurisdictions.
• Represented Geneius Biotechnology, Inc in a dispute with a minority shareholder that attempted to gain control of the company. In an expedited matter, we served as lead trial counsel in the Delaware Chancery Court and secured a total victory for the client.

Patent Prosecution & Strategic Counseling

• Conducted a freedom to operate assessment for a client which produces a clinical diagnostic product, essentially a lab-on-a-chip which provides for point of care testing for a wide range of infections. Most such tests have to be conducted at a central laboratory, which increases expense and causes a significant wait for results. The company's product allows treatment professionals to carry out testing on-site. We reviewed numerous third-party patents to advise the company that it had freedom to operate.
• Conducted a broad scope due diligence for a medical device manufacturer as it considered investing in a company operating in the electrical nerve stimulation space. This effort involved understanding the technology and the details of future, to-be-developed products. It was necessary to assess the potential for the company to have freedom to market these future products. In doing so, detailed evaluations of some patents were necessary. Our study also assessed the quality of the patent protection in place at the investee, with the goal of determining the effectiveness of the portfolio to prevent third parties from successfully marketing competing technology. We ultimately advised our client that the target company had clearance to operate and the client made the investment.
• Advised medical device client on developing and implementing a post-litigation strategy. Having lost a patent litigation (in which they were represented by another law firm), Mintz attorneys helped the company assess whether they could keep their product on the market during the appeal process. We then provided advice on how to create possible design-arounds for the product to ensure it was clear of infringing the patents at issue, in the event that the appeal was unsuccessful.
• Represent a leading nonprofit clinical research center, hospital, and graduate school which is a founding member of the National Comprehensive Cancer Network. The center is focused on the treatment of cancer, diabetes, and other life-threatening diseases, and has been designated as a comprehensive cancer center, the highest acknowledgment granted by the National Cancer Institute. The firm's attorneys have represented the hospital in developing and implementing strategies for procuring patents in a variety of chemical and biomedical technologies.
• We are trusted by a high-profile San Diego-based vision-focused medical device incubator with helping to assess and develop the patent strategies of its portfolio companies, and have been key legal counsel in recent successes of its portfolio companies. In 2016 and 2017, two of the incubator's companies were acquired by global corporations.
• Represent a leading worldwide provider of transfusion and transplantation diagnostic products, including instruments, reagents, antibodies, and molecular assays, serving as go-to counsel on both patent prosecution and technology- or IP-based commercial transactions. The company, which grew significantly in 2015 through a series of major acquisitions on which they were represented by members of the Mintz team, trusts the firm for insights into the value of the IP held by potential acquisition targets, including not only what is covered, but also the quality of the protections provided by the portfolio considering other competition in the marketplace. Our relationship attorney for this client serves as Chairman of the company's IP Management Committee, helping the client integrate technologies from acquisitions, including developing the offensive and defensive strategies for those patent families in order to maximize their marketplace value.