Life Sciences Transactions
We are general business lawyers who focus on intellectual property and commercial transactions in the life sciences industries. This makes us particularly able to meet the interdisciplinary demands of this practice. Our clients range from small, development-stage pharmaceutical and biotechnology companies to some of the largest and well-known pharma and biotech companies in the world.
Our clients praise us for understanding the products and processes that they develop, license, produce and sell, and how they fit into their business strategies. Our experience covers the entire product life cycle, from research to development to pre-clinical, clinical and commercial contract manufacturing, to filling, finishing and packaging, to storage, testing, clinical trials and distribution. At every stage we work with our colleagues in other practice areas and offices to address the interplay of our transactions with food and drug law in the U.S. and the EU (including cGMPs and pharmacovigilance regulations), privacy laws (including HIPAA and the EU Data Directive), Medicare fraud and abuse laws, tax, antitrust/competition, government contract regulation, export controls and product liability.
We have particular experience with:
- Licenses of gene expression systems
- Manufacturing, filling and finishing of monoclonal antibodies and related quality agreements
- Pharmacovigilance and related EU qualified person agreements
- EU drug distribution agreements
- Co-development and co-promotion agreements
Recent assignments include:
- We advised a major pharma company on the intellectual property and regulatory issues of a European joint venture for the distribution of anti-asthma drugs.
- We advised a major pharma company on co-development/co-promotion agreements relating to promising cancer and autoimmune disease therapies.
- We handle licenses, development agreements, joint ventures and the intellectual property aspects of acquisitions for two major medical products suppliers.
- We handle development, contract manufacturing, fill-finish and other supply-chain agreements for a major biopharma company.
- We regularly advise a U.S. pharma company on quality and pharmacovigilance agreements, and are advising it now on its agreements to introduce its major oncology product into Europe.
- We helped one of the country’s premier medical centers license its inventions and technology to licensees ranging from start-ups to major pharma companies.
- We advised a private AIDS/HIV research institute on an in-bound license agreement with a university covering delivery methods for anti-viral drugs.
- We advised a leading U.S. pharma company on the intellectual property and licensing rights relating to its proposed acquisition of a well-known OTC drug.
- We guided an international medical device company on its alliance to develop biological wound-care products.
- We helped a non-U.S. life sciences company with the out-licensing of an anti-bacterial drug.
- We assisted a non-U.S. life sciences company negotiate a joint development and commercialization agreement for an anti-viral drug.
- We advised a specialty pharmaceutical company in connection with the in-licensing of central nervous system drugs for further clinical development and commercialization.
- We advised an early-stage U.S. company on a joint development and license agreement for research on a method for inhibiting the binding of certain proteins that have been linked to Alzheimers and other cognitive impairment diseases.
- We advise an early-stage biotech company on contract manufacturing, process license, fill-finish, CRO and clinical trial agreements relating to the ongoing development of its initial monoclonal antibody product.