Cases
Representative Matters: Represented Patrin Pharma in Hatch-Waxman litigation related to Assertio's migraine medication, Cambia (Assertio Therapeutics, Inc. et al. v. Patrin Pharma, Inc., Civil Action No. 20-cv-05055 (N.D. Ill.). Achieved a settlement
license agreement related to all asserted patents.
Represented Windlas Healthcare PVT. Ltd. against Astellas Pharma Inc. in Hatch-Waxman litigation related to Astellas' overactive bladder treatment Myrbetriq. The matter settled with a license agreement between Astellas
Windlas.
Represented iAnthus Capital Holdings, Inc. (CSE: IAN
OTCQX: ITHUF) in its acquisition of CBD For Life, a top-ranked producer of innovative CBD-infused wellness, self-care,
beauty products.
Conducted a twelve state analysis of federal
state regulatory framework pertaining to the distributing, marketing,
selling of hemp
hemp-derived CBD, including CA, VA, MD, NC, PA, OH, KY, IN, WV, OR, WA
NY.
Represented SVB Leerink LLC, acting as sales agent in a $100 million at the market equity offering of common stock for Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company which works to develop novel solutions for Alzheimer's disease
other neurodegenerative diseases.
Represented Roth Capital Partners, LLC, acting as sales agent in a $50 million at the market equity offering of common stock for Ampio Pharmaceuticals, Inc. (NYSEAmerican: AMPE), a development stage pharmaceutical company attempting to develop a treatment for prevalent inflammatory conditions for which there are limited treatment options.
Represented JonesTrading Institutional Services LLC, acting as sales agent in a $30 million capital on dem
offering of common stock for Curis, Inc. (Nasdaq: CRIS), a clinical-stage biotechnology company seeking to develop
commercialize innovative drug c
idates for the treatment of human cancers.
Represented The Benchmark Company LLC, acting as underwriter in a $12.5 million offering of preferred stock for Fortress Biotech, Inc. (Nasdaq: FBIOP), a developer of pharmaceutical
biotechnology products
product c
idates.
Represented B. Riley FBR, Inc., acting as sales agent in a $150 million at the market equity offering of common stock for Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company focused on the discovery, development
commercialization of vaccines to prevent serious infectious diseases, including a potential COVID-related vaccine.
Represented B. Riley FBR, Inc., acting as sales agent in a $4.6 million at the market equity offering of common stock for Hepion Pharmaceuticals, Inc. (NYSE American: HEPA), a developer of targeted therapies for liver disease arising from chronic hepatitis, non-alcoholic steatohepatitis, fibrosis,
liver cancer.
Represented JMP Securities LLC, acting as sales agent in an $18.9 million at the market equity offering of common stock for Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company which develops treatments for liver disease
immune modulating therapies.
Represented JMP Securities LLC, acting as sales agent in a $25 million at the market equity offering of common stock for iCAD, Inc. (Nasdaq: ICAD), a global medical technology company that provides innovative cancer detection
therapy solutions.
Represented JMP Securities LLC
Oppenheimer & Co., acting as underwriters in a $25 million public offering of common stock
related warrants for Baudax Bio, Inc. (Nasdaq: BXRX), a pharmaceutical company primarily focused on developing
commercializing innovative products for acute care settings.
Advised publically traded company related to banking covenants
offering of CBD products.
Represented Flexpoint Ford, a Chicago-based private equity firm focused on the healthcare
financial services industries, in its investment in YPrime, a global leader of cloud-based eClinical solutions.
Represent a vertically-integrated operator with licenses in MA, MD,
NH in various aspects of its business, including general corporate, capital raising,
intellectual property.
Represented underwriter related to At the Market (ATM) offering by a publically traded company considering offering CBD infused cosmetics
beverages.
Advised a client in the tobacco industry on labeling of CBD products to comply with federal
state law.
Reviewed advertising
promotional material for multiple companies offering CBD products to assure compliance with federal law (FDA
FTC).
Drafted a compliance program covering the anti-kickback statute, FCPA, UK Bribery Act,
employee screening for debarment
exclusion for a CSO that provides services to clinical studies sponsors.
Represented firm client Wockhardt in New Jersey related to Janssen Biotech Inc.'s oncology medication Zytiga. The District Court found the Janssen patent invalid.
Represented a generic pharmaceutical manufacturer in Inter Partes Review litigation related to a prescription drug resulting in an agreement to settle with a license date prior to expiration of patents.
Provided regulatory
intellectual property support to the in-house regulatory team of Wockhardt, a pharmaceutical
biotechnology company, for the development of a Risk Evaluation
Mitigation Strategy ( REMS ) for a generic sodium oxybate product that was recently approved by the U.S. Food
Drug Administration ( FDA ).
Obtained voluntary no-pay dismissals for a pharmaceutical distributor after filing summary judgment motions establishing that our client's over-the-counter talcum powder was not contaminated with asbestos
that the plaintiffs' personal injury claims were preempted by the Federal Food, Drug
Cosmetics Act.
Jazz Pharmaceuticals, Inc. et al. v. Wockhardt Bio AG et al., 2:15-cv-5619 (D.N.J. 2015). Obtained settlement for defendant Wockhardt Bio AG in a patent litigation matter relating to Jazz Pharmaceutical's treatment for narcolepsy, Xyrem.
Obtained on behalf of Novel Laboratories Inc. a settlement of a patent litigation matter, which will allow Novel to begin marketing its generic form of a medication well prior to the expiration of the patents.
Represented Wockhardt in Paragraph IV litigation involving Otsuka's oral Abilify. Negotiated a settlement
license agreement permitting entry into the market prior to the expiration of the Orange Book Patents.
Pfizer Inc., et al. v. Wockhardt, Ltd., et al., 12-CV-817 (SLR) (Consolidated) (D. Del.) Patent infringement action regarding Wockhardt's ANDA to make a generic version of Pfizer's antidepressant product Pristiq, the active ingredient of which is desvenlafaxine succinate.
Avanir Pharmaceuticals, Inc., et al. v. Wockhardt, Ltd., et al., 11-CV-704 (Consolidated) (LPS) (D. Del.) Obtained a settlement in a patent infringement action allowing Wockhardt to market a generic version of Avanir's PBA product Nuedexta, the active ingredients of which are dextromethorphan hydrobromide
quinidine hydrobromide.
Obtained a settlement for Wockhardt, a global pharmaceutical
biotechnology company, with Abbott
Alkermes regarding the drug Tricor.
Obtained a settlement for Wockhardt, a global pharmaceutical
biotechnology company, that resolved Hatch-Waxman litigation initiated by Sepracor Inc. seeking to bar Wockhardt from offering a generic version of the blockbuster insomnia medicine Lunesta. Sepracor agreed to allow Wockhardt entry into the market before the expiration of its Lunesta patents.
Represented generic pharmaceutical manufacturer Wockhardt in Paragraph IV
Hatch-Waxman litigation, obtaining settlement allowing entry into the market prior to patent expiration.
Obtained return of $1.6 million worth of alleged contrab
seized by the U.S. Drug Enforcement Administration.
Advised private equity firm in acquisition of dietary supplement manufacturer regarding U.S.
China regulatory issues.
Represented dietary supplement manufacturer in negotiation of consent decree with FDA following alleged repeated violations of good manufacturing practices.
Obtained temporary restraining order against state of Washington halting a 6 percent reduction in Medicaid reimbursement to pharmacies.
Negotiated voluntary surrender of DEA registration on behalf of pharmacy
owner allegedly engaged in significant diversion of controlled substances in violation of federal
state law. In return, DEA agreed not to pursue criminal or civil actions
permitted transfer of controlled substances to another pharmacy.
Obtained no further action letter from state authorities on behalf of corporation
new management following voluntarily self-reporting of violations of state controlled substances act
statutes
regulations governing out of state wholesalers after internal investigation.
Represented dietary supplement manufacturer in criminal proceedings related to violations of Food Drug
Cosmetic Act.
Represented dietary supplement manufacturer before the National Advertising Division of the Better Business Bureau regarding advertising claims.
Obtained preliminary injunction on behalf of National Association of Chain Drug Stores
National Community Pharmacists Association in litigation against federal Department of Health
Human Services
Centers for Medicare
Medicaid enjoining implementation of reimbursement rule that would have cost pharmacies $8 billion.
Ikon v. Reeves: obtained temporary restraining order
preliminary injunction enforcing restrictive covenants
Innotek v. Wright Medical: successful defense of trade secrets arbitration
Gustafson v. Gonzales: obtained temporary restraining order
permanent injunction enforcing restrictive covenants
Represented drug wholesaler in criminal
civil investigation regarding importation of unapproved new drugs.
Represented several mail order pharmacies in DEA, FDA,
DOJ investigations regarding dispensing of controlled substances.
Prepared
negotiated voluntary recalls on behalf of several manufacturers of dietary supplements
generic pharmaceuticals for alleged violations of cGMP.
Advised numerous wholesalers
manufacturers on registration
pedigree requirements.
Advised numerous entities on import requirements for registration
APIs.
Represented compounding pharmacy during criminal, civil,
administrative investigation into dispensing HGH.
Represented a generic pharmaceutical company in all regulatory matters related to acquisition.
