Biotech & Pharmaceutical

Hart David Carson LLP acts for therapeutics and platform companies across the development arc, from early discovery ventures and clinical-stage biotechs to specialty and generic pharmaceutical businesses and the contract research and manufacturing organizations that support them. We also act for the venture funds, family offices, and strategic investors who finance them. The common thread is a science-led business where corporate structure, capital, intellectual property, and regulatory pathway all have to line up before value can be realized.

We advise on what the pathway does to the deal, and we leave the submission itself to the regulatory affairs specialists we coordinate with. The pathway sets the terms: an orphan designation adds seven years of market exclusivity and changes what a licensee will pay; a breakthrough or fast-track designation shortens the time to a readout and so the time to the next tranche; a complete response letter is a defined event in most financing and collaboration documents, with consequences written in advance. We draft those consequences, keep the regulatory timetable and the financing timetable on one calendar, and read the investigational new drug and pre-submission correspondence for what it commits the company to. The FDA is the regulator this work answers to, and the file we build is the one its reviewers and a buyer's diligence team will both read.

For a therapeutics venture the patent estate and trade-secret program are often the principal asset, so we treat IP as a corporate question from the first day. We handle licensing, collaboration, and assignment agreements, freedom-to-operate and ownership diligence, and the IP terms inside financings and M&A. Where patent prosecution or patent opinion work is required, we coordinate with registered patent counsel so the filings and the deal documents reinforce one another.

We structure and document the full capital arc: convertible and SAFE instruments at the seed stage, priced venture and growth equity rounds, milestone- and royalty-based deals, and venture-debt facilities. Biotech capital is staged against scientific milestones, so the terms have to anticipate dilution, future rounds, and partnering or exit scenarios. We build the cap table and the financing documents to hold through that whole sequence rather than through the current round alone.

Yes. Out-licensing, in-licensing, research collaborations, option and co-development arrangements, and supply and manufacturing agreements are central to how value moves in this sector. We negotiate the economics of upfronts, milestones, and royalties alongside the control terms that decide who owns improvements, who runs development, and what happens on change of control, so the agreement protects the company well beyond signing.

Yes. The usual shape is a Delaware parent that holds the patents and raises the capital, a subsidiary in the jurisdiction where the trials run, and sometimes a manufacturing or research entity in a third. Three documents hold that shape together: the intercompany license that lets the subsidiary use the patents and sets a royalty the tax authorities on both sides will accept, the clinical trial agreements that assign data and inventions back to the parent, and the data-transfer terms that let patient-level data cross borders lawfully. A Series B investor or an acquirer traces all three, and a redomiciliation later is expensive precisely because they were not designed to move. We coordinate the structure with locally admitted counsel in each jurisdiction and set it up once, early, to be sold.