Life Sciences

Commercialization

• 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.
• Draft and negotiate product purchase and sale agreements.
• Draft and negotiate capital equipment rental and service agreements.
• Negotiate development, manufacturing and supply agreements for drug, device and diagnostics manufacturers.
• Develop health care compliance policies and provide counsel for implementation of HCC programs.
• Obtain licenses and permits from State Boards of Pharmacy.
• 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.
• 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.
• 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.
• 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.
• Represented licensee in the license of various patents and technology owned by public university research foundation to start-up biotechnology company.

Securities

• 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.
• Acquisition of plasma centers by privately-held human-source plasma supply company for consideration of $150 million.
• Acquisition of plasma centers by privately-held human-source plasma supply company for consideration of $99 million.
• Sale by publicly-traded diagnostics manufacturer of its hematology instrumentation system and reagent test kits to diagnostics manufacturer based in China. 
• Sale by publicly-traded diagnostics manufacturer of its hematology subsidiary to a publicly-traded diagnostics manufacturer based in Sweden. 
• Sale of a portfolio of specialty chemical manufacturing companies to privately-held specialty chemical business for $145 million of consideration.
• Acquisition of three privately-held chemical engineering and manufacturing company by private equity firm’s specialty chemical and manufacturing platforms for $89 million in aggregate consideration.

Capital Markets

• 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. 
• 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. 
• Issuer’s counsel in diagnostics testing company’s $33 million offering of convertible preferred securities and shadow convertible preferred securities.
• Represented board of directors of publicly-traded biopharmaceutical company in proxy contest and proxy solicitation campaign.
• Private equity firms’ $35 million investment to launch a roll-up strategy by founders for veterinary clinics.
• Issuer’s counsel for mezzanine investment of $80 million by private equity fund in privately-held hospitality company. 
• Issuer’s counsel in $30 million private investment in public equity (PIPE) for diagnostics manufacturer.

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.

Litigation

• 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.