Licensing & Strategic Alliances

• Alloy Therapeutics (biotech ecosystem company) in a strategic collaboration and licensing agreement with Takeda to develop and commercialize iPSC-driven CAR-T (iCAR-T) and CAR-NK (iCAR-NK) cell therapy platforms for oncology indications.
• LigaChem Biosciences (KRX: 141080) in numerous collaboration agreements, including two transactions licensing ADC technology to Ono Pharmaceutical (up to $700 million in upfront/milestones plus royalties), two antibody licensing deals with NovaRock Biotherapeutics for ADC development, a worldwide in-licensing transaction with Go Therapeutics for an ADC antibody platform, and an antibody discovery agreement with Trican Biotechnology.
• Novo Nordisk A/S (NYSE: NVO) in a collaboration with Aspect Biosystems to develop up to four bioprinted tissue products for diabetes and obesity ($75 million upfront, up to $650 million/product in milestones, plus royalties).
• Daewoong Pharmaceutical (KRX: 069620) in multiple transactions including an exclusive license with CS Pharmaceuticals for PRS inhibitor "Bersiporocin" in Greater China and an exclusive license with Vitalli Bio for a first-in-class BTK/ITK targeting drug.
• AcuraStem in a license agreement with Takeda to develop PIKFYVE targeted therapeutics for ALS (up to $580 million, plus royalties).
• Ginkgo Bioworks (NYSE: DNA) in collaborations with Merck (enzyme engineering for biocatalysts), Novo Nordisk (novel expression hosts), Sumitomo Chemical (bio-based commercial products), and Biogen (next-gen recombinant AAV production platform).
• MedRhythms in a license agreement with Biogen for MR-004, an investigational prescription SaMD for gait deficits in MS ($3 million upfront, up to $117.5 million milestones, plus royalties).
• Concerto Biosciences in a development and commercialization agreement with Sacco System.
• Intellia Therapeutics (Nasdaq: NTLA), a CRISPR/Cas9 genome editing company, in a strategic collaboration with SparingVision for new ocular therapies.
• Dicerna Pharmaceuticals (Nasdaq: DRNA) in a $175 million+ collaboration with Novo Nordisk for liver-related cardio-metabolic diseases and a $1.67 billion+ collaboration with Roche to develop DCR-HBVS for chronic Hepatitis B.
• LG Chem Life Sciences in a $900+ million multi-target collaboration with CUE Biopharma covering immuno-oncology programs CUE-101, CUE-102, and CUE-103.

Patent Litigation

• Representing Geneoscopy in patent infringement and false advertising case brought by Exact Sciences concerning RNA-based colorectal cancer tests and two IPR proceedings .
• Representing La Jolla Pharma in an action under 35 U.S.C. § 145 challenging USPTO rejection of patent applications covering the dosage form of Giapreza®.
• Defending Elysium Health in lawsuit alleging infringement of patents related to nicotinamide riboside; obtained PTAB ruling invalidating half the asserted claims, summary judgment ruling invalidating the other half, and an award of attorneys’ fees (currently on appeal at the Federal Circuit).
• Represented Dana-Farber Cancer Institute in landmark inventorship/ownership litigation against Bristol-Myers Squibb and Ono Pharmaceutical concerning PD-1/PD-L1 cancer immunotherapy patents; obtained judgment correcting inventorship, affirmed by Federal Circuit. Also represented Dana-Farber in second case against BMS/Ono asserting unjust enrichment for depriving Dana-Farber of co-ownership; obtained substantial lump sum settlement.
• Represented Becton, Dickinson and Company in district court actions against Affymetrix and Beckman Coulter, as well as PTAB proceedings, concerning patents covering polymer dye reagents for flow cytometry; obtained favorable settlements.
• Defended Celsee in patent infringement/false advertising dispute with 10x Genomics concerning single-cell analysis instruments; obtained favorable settlement before trial.
• Defended Epicypher in patent infringement dispute with Active Motif concerning targeted transposition for analysis of protein interactions with DNA; obtained early dismissal.
• Represented UMass in dispute over ownership of patents involving siRNA technology; obtained confirmation of UMass's ownership rights.
• Represented Bioverativ Therapeutics in ITC investigation asserting patent on long-lasting Factor IX products against CSL Behring; favorable claim construction and defeated IPR challenges.
• Represented Biogen in patent dispute with Novartis regarding expression systems; obtained favorable settlement before trial.
• Represented respondents in ITC investigation concerning Ajinomoto patents on genetically engineered bacteria for lysine production; obtained invalidity and inequitable conduct ruling, affirmed by Federal Circuit.
• Represented Biogen in defense of patent suit by Classen Immunotherapies; obtained dismissal with prejudice plus "exceptional" case finding and attorneys' fees.
• Defended Biogen against Sanofi-Aventis Deutschland in patent dispute concerning human CMV regulatory sequences; obtained summary judgment of non-infringement affirmed by Federal Circuit.

Trade Secrets Litigation

• Defending Alexion Pharmaceuticals in litigation by Amyndas Pharmaceutical alleging theft of trade secrets and breach of contract in connection with C3 inhibitor therapy development.
• Representing Geneoscopy in assertion of trade secret counterclaim against Exact Sciences concerning RNA-based colorectal cancer test.
• Represented Krystal Biotech in litigation by PeriphaGen alleging misappropriation of trade secrets in connection with vector development (HSV-1 vectors for treating skin disorders); obtained favorable settlement.
• Represented UMass in dispute alleging patents involving siRNA technology contained proprietary information of a clinical-stage biopharma company; obtained consent judgment confirming UMass ownership.

Mergers & Acquisitions

• Lantheus Holdings, Inc. (NASDAQ: LNTH) in the sale of its single photon emission computed tomography (SPECT) business to SHINE Technologies, LLC, a subsidiary of Illuminated Holdings, Inc.
• Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, in its acquisition of StrideBio’s adeno-associated virus (AAV) capsid discovery and engineering platform assets
• Applied Genetic Technologies Corporation (Nasdaq: AGTC), a clinical-stage biotechnology company focused on the development and commercialization of adeno-associated virus (AAV)-based gene therapies for the treatment of rare and debilitating diseases, in its sale to in its sale to Syncona Limited (LON: SYNC) for approximately $23.5 million in cash ($0.34 per share)
• MDxHealth in its acquisition of the Oncotype DX GPS prostate cancer testing business from Exact Sciences subsidiary Genomic Health in a deal worth up to $100 million
• United States Medical Supply (US Med) in the sale of its urology division to Strive Medical
• Prescription digital therapeutics company Pear Therapeutics in its $1.6 billion business combination agreement with Thimble Point Acquisition Corp. (Nasdaq: THMA), a special purpose acquisition company (SPAC) whose management team is associated with the Pritzker Vlock Family 
• Alloy Therapeutics in its acquisition of antibody discovery technologies from Lanier Biotherapeutics, a developer of first-in-class antibodies targeting retina, dermatology, and Type 2 Inflammatory specialty diseases
• Ovuline (d/b/a Ovia Health), a digital health company focused on maternity and family benefits for employers and health plans, in its sale to a leading global life sciences company Labcorp (NYSE: LH)
• Genuity Science, a genomics data, analytics and insights company, in its sale to HiberCell, a clinical stage biotechnology company developing therapeutics to treat cancer relapse and metastasis 
• GreenLight Biosciences, a biotechnology company dedicated to making RNA products affordable and accessible for human health and agriculture, in a $1.2 billion SPAC business combination with Environmental Impact Acquisition Corp. (Nasdaq: ENVI), that resulted in GreenLight becoming a publicly listed company
• Novellus Therapeutics, a developer of novel medicines intended for the treatment of pediatric disease, in its sale to Brooklyn ImmunoTherapeutics (NYSE: BTX) for $125 million
• Global biotechnology company Thermo Fisher Scientific (NYSE: TMO) in multiple acquisitions, including in its:
  • acquisition of PeproTech, a Cranbury, New Jersey-based provider of bioscience reagents for $1.85 billion 
  • acquisition of Combinati Incorporated and its digital PCR (dPCR) technology
  • acquisition of programmable dye platform pioneer Phitonex
  • $1.7 billion acquisition of Brammer Bio, a leader in viral vector manufacturing for gene and cell therapies
  • $477 million acquisition of Becton, Dickinson and Company’s Advanced Bioprocessing business
• Dogma Therapeutics, a developer of oral PCSK9 inhibitors to treat high cholesterol and cardiovascular disease, in the sale of its oral PCSK9 program to global biopharmaceutical company AstraZeneca for upfront as well as downstream payments linked to global regulatory and commercial milestones
• Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) in its acquisition of clinical-stage biopharmaceutical company Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) worth up to $1.2 billion

Emerging Company & Venture Capital

• ArkeaBio, an ag-biotech start-up developing a vaccine to reduce livestock methane emissions, in closing a $26.5 million Series A financing. 
• Genialis, a computational precision medicine company, in its $13 million Series A financing to expand its machine learning platform for clinical and translational research. 
• Vergent Bioscience, a clinical-stage biotechnology company developing tumor-targeted imaging agents, in a $21.5 million Series B financing. 
• Alloy Therapeutics, a biotechnology ecosystem company, in a $42 million Series D financing round. 
• BostonGene, a developer of biomedical software for advanced patient analysis and personalized therapy, in its $150 million Series B financing that propelled it to unicorn status ($1 billion+ valuation). 
• AeroSafe Global, provider of outsourced cold chain management services to pharmaceutical, biopharmaceutical, specialty pharmacy and medical device companies, in the $4 million second closing of its Series F financing. 
• Alloy Therapeutics in multiple matters, including its $75.0 million Series C financing led by 8VC, Presight Capital and Peter Thiel; formation of Broadwing Bio LLC, a joint venture with Maze Therapeutics to develop targeted antibody therapies for ophthalmic diseases; and as an investor in the $21 million Series A of Vernal Biosciences, a manufacturer of high purity mRNA for research and clinical use. 
• Alcyone Therapeutics in $23.0 million financing led by RTW Investments to support pioneering development of next-generation precision central nervous system therapies. 
• Jana Care, developer of a mobile diagnostic platform for diabetes diagnosis and treatment, in its $14.4 million Series B financing.  
• TrialJectory, operator of an AI-based healthcare platform connecting cancer patients with clinical trials, in its $20 million Series B financing led by Insight Venture Management. 
• Satellite Bio, a regenerative medicine company, in raising $110 million in Seed and Series A funding. 
• RedShift BioAnalytics Inc. (RedShiftBio), a company providing next-generation platform technology for measurement of structure changes in biomolecules, in its $20 million Series E financing. 
• Form Health, a leading provider of science-based obesity care, in its $38 million Series B and $12 million Series A financing rounds.  
• KnipBio, Inc. in venture financings and strategic collaborations. 
• Kula Bio, Inc. in $50 million Series A financing. 
• Vergent Bioscience, Inc. in $11 million Series A financing. 

Patent Portfolio Management and IP Due Diligence

• Represented Novartis (NYSE: NVS), a global healthcare company, on IP due diligence in its acquisition of Tourmaline Bio, complementing its cardiovascular pipeline with pacibekitug for the treatment of atherosclerotic cardiovascular disease (ASCVD).
• Provided IP diligence support to Genmab A/S (NASDAQ: GMAB), an international biotech specializing in antibody therapeutics for cancer, in its $8 billion acquisition of Merus.
• Represented Chiral Technologies (Daicel Corporation) on IP aspects of its acquisition of Arbor Biosciences, a pharmaceutical services firm using massively parallel DNA synthesis technology.
• Represented Proteolix, Inc. on IP matters from inception to acquisition by Onyx Pharmaceuticals ($276M cash + up to $575M performance payments), including the global patent portfolio for carfilzomib (Kyprolis®).

Capital Markets

• Enanta Pharmaceuticals (Nasdaq: ENTA), a clinical-stage biotechnology company, in its $74.8 million public offering, including the underwriters' full exercise of their option to purchase additional shares. 
• GreenLight Biosciences, a biotechnology company, in a $1.2 billion SPAC business combination with Environmental Impact Acquisition Corp., resulting in GreenLight becoming a publicly listed company. 
• Applied Genetic Technologies Corp. (Nasdaq: AGTC), a biotechnology company conducting human clinical trials of AAV-based gene therapies, in numerous capital markets transactions including an ATM offering program (up to $50 million), an underwritten public offering of 16,741,573 shares, an up-to-$25 million ATM offering, a $37.4 million underwritten public offering, and its $52 million IPO. 
• Biogen Inc. in several sophisticated debt finance transactions, including a registered offering of senior unsecured notes for $3 billion, a cash tender offer and exchange offer for outstanding 5.200% senior notes totaling $1.75 billion, and a senior unsecured syndicated credit facility for $1 billion. 
• Enanta Pharmaceuticals in its initial public offering of common stock. 
• Organogenesis Holdings and its subsidiary Organogenesis Inc., a leading regenerative medicine company, in its $64.7 million and $50.3 million underwritten public offerings, its warrant exchange offer and consent solicitation, and a SPAC IPO/reverse merger. 
• Lantheus Holdings (Nasdaq: LNTH) in a Rule 144A offering of $575 million aggregate principal amount of 2.625% convertible senior notes due 2027. 
• Butterfly Network (NYSE: BFLY), a digital health company, in its $86.9 million public offering
• Ginkgo Bioworks (NYSE: DNA) in its acquisition of StrideBio's adeno-associated virus (AAV) capsid discovery and engineering platform assets. 
• Applied Genetic Technologies Corporation (Nasdaq: AGTC), a clinical-stage biotechnology company focused on AAV-based gene therapies, in its sale to Syncona Limited for approximately $23.5 million in cash. 
• GreenLight Biosciences, a biotechnology company dedicated to making RNA products affordable and accessible, in a $1.2 billion SPAC business combination with Environmental Impact Acquisition Corp.

FDA Regulatory Strategy and Product Approval ​​​​​

• Guided biotechnology companies through available FDA pathways to market, including investigational and expedited programs, biologics and drug approvals, and regulatory exclusivity frameworks. 
• Assisted medical device manufacturers and digital therapeutics companies with pre-market notifications, de novo submissions, and product approvals.
• Advised on product classification, clinical and preclinical development strategy, and regulatory submissions, as well as labeling, promotional review, and compliance. 
• Helped clients develop and execute integrated regulatory strategies, engage effectively with FDA at critical inflection points, and advance scientifically grounded advocacy to support approval, clearance, and commercialization. 
• Supported successful product launches and lifecycle management for therapeutics, biologics, diagnostics, and digital health products.

Medical Products Coverage & Reimbursement

• Developed novel legal arguments and assembled scientific evidence that secured a critical policy decision affecting the coding and payment for biotechnology products. 
• Successfully advocated for changes to CMS's coding policy for biosimilar biological products and date-of-service billing policies for molecular diagnostic laboratory tests, including advocacy before HHS Office of General Counsel. 
• Helped CMS design and create one of the first data registries in its Coverage with Evidence Development (CED) program, advising a coalition of leading academic medical centers and medical device manufacturers. 
• Advised numerous molecular diagnostic companies on Medicare coverage, payment, and implementation of the Protecting Access to Medicare Act (PAMA) of 2014, including establishment of the Advanced Diagnostic Laboratory Test (ADLT) payment category and approval of the first ADLTs. 
• Represented a manufacturer of therapeutic radiopharmaceutical products before CMS and Congress, leading to the creation of a new payment methodology. 
• Developed the legal argument to help secure the first Medicare New Technology Add-on Payment (NTAP) for an oral drug in the hospital inpatient payment system. 
• Assisted biopharmaceutical companies and molecular diagnostic laboratories in developing price reporting policies to set Medicare rates. 
• Worked with the Center for Medicare and Medicaid Innovation (CMMI) on innovative payment and service delivery models to improve quality of care.