Stearns Weaver Miller’s Life Sciences Industry Group understands the business environment and unique challenges facing clients in this industry sector. Our team includes attorneys with substantial in-house experience working for both pharmaceutical and medical device companies, and many others with years of experience providing counsel to medical device, diagnostics and pharmaceutical companies.
Our firm’s attorneys have a wide range of experience representing medical device, diagnostics and pharmaceutical companies in corporate and other commercial matters. Our attorneys have extensive experience in conducting securities offerings for, and mergers, acquisitions and sales of, medical device, diagnostics and pharmaceutical companies, as well as in negotiating and documenting commercial transactions on behalf of life sciences companies, including: supply, manufacturing, licensing, and distribution agreements with inventors of technology and intellectual property, external suppliers and original equipment manufacturers; joint venture and strategic alliance agreements between our clients and other industry participants; and clinical trial, educational grant, consulting, and fellowship agreements between our clients and health care providers, research institutes and physicians. We also counsel clients on a wide range of issues relevant to life sciences companies, including health care compliance, anti-kickback regulations, the Foreign Corrupt Practices Act, pricing and contracting activities, and corporate compliance matters.
Our attorneys also help life sciences companies with their real estate and physical plant requirements. We have extensive experience assisting clients with the purchase and leasing of laboratory and pharmaceutical processing facilities, manufacturing plants, logistics centers, and clean room facilities.
Our firm also has extensive experience in all aspects of life sciences litigation, including generic drug approval litigation and marketing exclusivity litigation under the Hatch-Waxman Act, intellectual property and drug and technology development disputes between rival companies, disputes with raw materials and other suppliers, product liability, counterfeiting, and a host of other medical device, diagnostics and pharmaceutical litigation matters. Our firm has won numerous cases in federal courts across the country against brand name pharmaceutical companies seeking to block generic drug approvals through patent and other litigation brought under the Hatch-Waxman Act. We also have broad experience defending and prosecuting class actions, and particularly those involving antitrust or securities law violations in the life sciences industry.
- Commercial & Operational Agreements
- Healthcare Compliance & Training
- Labor & Employment
- Licensing & Commercialization
- Medical Devices, Diagnostics & Pharmaceuticals
- Mergers & Acquisitions
- Product Life Cycle Management
- Real Estate
- Regulatory Compliance
- Represent manufacturers and distributors in negotiation of domestic and international medical device, diagnostic and pharmaceutical distribution agreements.
- Draft and manage process for negotiation of clinical trial and registry agreements with universities and principal investigators on behalf of device and pharmaceutical manufacturers.
- Negotiate supply agreements for drug, device and diagnostics manufacturers.
- Represented a private-equity owned medical device and pharmaceutical company in connection with acquisition by multi-national medical device and hospital supply company.
- Represented coronary stent manufacturer in development, manufacturing and supply agreement.
- Represented licensee in the license of technical information and know-how for the manufacture of allergy diagnostic test kits.
- Represented owner of intellectual property and raw materials in a manufacturing and supply agreement for an over-the-counter, topical pharmaceutical product.
- Represented licensees in the license of various patents and technology owned by public university research foundations to start-up medical device companies and biotechnology companies.
- Represented manufacturer in reagent rental program for diagnostics instrumentation systems and reagent test kits.
- Represented distributor in a supply and distribution agreement for automated diagnostics systems and related consumables and accessories.
- Negotiate GPO and IDN agreements as well as product purchase and sale agreements with individual hospitals in connection with representation of medical device, pharmaceutical and diagnostic companies.
- Negotiated third party logistics agreements on behalf of life sciences clients.
- Issuer’s counsel in Rule 144A offering of $144 million senior convertible debt for clinical drug development services company.
- Issuer’s counsel in $133 million follow-on equity offering for clinical drug development services company.
- Private equity firms’ $35 million investment to launch a roll-up strategy by founders for veterinary clinics.
- Issuer’s counsel in $30 million private investment in public equity (PIPE) for diagnostics manufacturer.
- Represented start-up medical device company in private placement of convertible notes, and capital-raise of matching-funds from technology seed capital fund using convertible notes.
- Represented board of directors of publicly-traded biopharmaceutical company in proxy contest and proxy solicitation campaign
Mergers & Acquisitions
- Acquisition of privately-held veterinary pharmaceutical manufacturing company by publicly-traded pharmaceutical company for $440 million of consideration consisting of stock and cash and redemption of indebtedness.
- Acquisition of publicly-traded developer and manufacturer of drug delivery technology by publicly-traded pharmaceutical company for consideration consisting of stock.
- Spin-off of then privately-held diagnostics manufacturer through reverse merger with publicly-traded blank-check company.
- Sale of controlling stockholder’s equity position in publicly-traded diagnostics manufacturer to a group based in France.
- Sale of online community for physicians by publicly-traded pharmaceutical company to one of the world’s largest online healthcare companies.
- Sale of controlling stockholders’ equity position in publicly-traded diagnostics manufacturer to a leading global diagnostics company based in India.
Compliance and Compliance Training
- Developed healthcare compliance programs and policies for companies ranging from start-up status to large, mature corporations.
- Provide regular HCC training to sales teams and executive management including training on Anti-Kickback Statute, the Foreign Corrupt Practices Act, HIPAA, and the AdvaMed and PhRMA Codes on Interactions with Healthcare Professionals.
- Managed process for obtaining licensure and permits from State Boards of Pharmacy for medical device companies.
- Represented developer and manufacturer of transdermal drug delivery systems in various litigation matters, including litigation over the ownership of core patents.
- Represented pharmaceutical manufacturer in patent and other litigation in various federal and state courts around the country in an effort to block generic competition for the largest selling anti-cancer drug in the world.
- Represented pharmaceutical company in litigation brought by numerous state governments in various courts around the country against numerous pharmaceutical manufacturers relating to various average wholesale price (AWP) issues in connection with pharmaceutical sales to those states.
- Represented pharmaceutical manufacturer in litigation against the FDA, overturning the Agency’s refusal to award marketing exclusivity for a generic pharmaceutical.
- Represented medical device manufacturer in patent litigation involving diabetes testing systems.
- Obtained a dismissal with prejudice of claims brought by a qui tam plaintiff under the False Claims Act in connection with the use of in-process validation methods to obtain drug approvals from the FDA.
David Seifer Appointed to Board of Directors of United Way of Miami-Dade
New Faces, Growing Places
In the Media:
Women in Law: Women Honored for South Florida Legal Accomplishments
Daily Business Review|October 2014
In the Media:
Top 20 Women in Law: DBR Recognizes South Florida Achievers
Daily Business Review|September 2014
In the Media:
Stearns Weaver Adds Real Estate, IT Partners In Miami
Eric Roth Joins the Firm