Biotech, Life Sciences & MedTech Legal Services
Montague Law advises biotechnology companies, life sciences startups, medical device manufacturers, and digital health platforms on the corporate, regulatory, and transactional challenges unique to the life sciences sector. From early-stage university spinoffs pursuing their first NIH SBIR grant to growth-stage companies navigating FDA submissions and strategic licensing transactions, our team delivers counsel that reflects a deep understanding of the science, the regulatory environment, and the capital formation strategies that drive this industry.
Life sciences companies operate on longer development timelines, face higher regulatory barriers, and require larger capital commitments than almost any other sector. Successfully navigating this environment requires legal counsel that understands not only the applicable legal frameworks, but the underlying science, the economics of drug and device development, and the expectations of specialized investors. That is the perspective Montague Law brings to every life sciences engagement.
Company Formation & Early-Stage Structuring
Life sciences companies present unique structuring considerations at formation. We advise founders — often academic researchers transitioning technology from university labs — on entity selection, IP assignment and licensing from research institutions, founder equity arrangements that account for long pre-revenue development periods, and the structuring of scientific advisory boards and consulting agreements with key opinion leaders. We also help companies establish compliant arrangements with university co-founders who may have ongoing academic obligations and conflict-of-interest policies to navigate.
FDA Regulatory Strategy
FDA regulatory pathway selection is one of the most consequential strategic decisions a life sciences company makes. Montague Law advises on the legal dimensions of FDA submissions including 510(k) premarket notifications, premarket approval (PMA) applications, de novo classification requests, Investigational New Drug (IND) applications, and Emergency Use Authorizations. We work alongside regulatory affairs consultants to ensure that corporate structuring, intellectual property strategy, and deal documentation are aligned with the company’s regulatory timeline and pathway. We also advise on FDA compliance obligations including Quality System Regulation (QSR), adverse event reporting, labeling requirements, and promotional compliance.
Life Sciences Venture Capital & Growth Financing
Life sciences companies typically require multiple rounds of financing over extended development periods, and the deal terms at each stage reflect the unique risk profile of the sector. We structure and negotiate seed rounds, Series A through C financings, crossover rounds, and pre-IPO placements for biotech and medtech companies. Our financing work accounts for milestone-based tranched funding, anti-dilution protections calibrated to clinical or regulatory risk events, board governance provisions, and investor information rights that address the sensitivity of pre-submission data.
Licensing, Collaboration & Strategic Partnerships
In-licensing, out-licensing, co-development, and strategic collaboration agreements are central to the life sciences business model. Montague Law drafts and negotiates these agreements with a focus on the issues that most frequently determine deal success or failure: field-of-use restrictions, exclusivity and territorial scope, milestone and royalty payment structures, intellectual property ownership of jointly developed inventions, diligence obligations, and termination and reversion rights. We represent both licensors and licensees, giving us perspective on how each side evaluates key commercial terms.
Intellectual Property Strategy
Intellectual property is the core asset of most life sciences companies, and IP strategy must be integrated with regulatory, commercial, and financing strategy from the earliest stages. We advise on patent portfolio development and prosecution strategy (working with patent counsel), trade secret protection programs for proprietary processes and data, freedom-to-operate analyses, IP due diligence in licensing and M&A transactions, and Hatch-Waxman and BPCIA patent term extensions and litigation strategy for pharmaceutical clients. We help companies build and defend IP positions that support both investor confidence and commercial defensibility.
Life Sciences M&A & Exit Transactions
Montague Law advises life sciences companies and their investors on mergers, acquisitions, asset purchases, and reverse mergers. Life sciences M&A involves distinct considerations including the valuation of pre-revenue companies based on clinical data and regulatory milestones, earnout structures tied to FDA approval events, representations and warranties regarding preclinical and clinical trial data integrity, and the allocation of post-closing development obligations. We structure transactions that account for the long-tail risk profile that distinguishes life sciences deals from other technology M&A.
Clinical Trial Agreements & Research Compliance
We draft and negotiate clinical trial agreements, clinical research organization (CRO) master service agreements, investigator-initiated study agreements, and sponsored research agreements with academic medical centers. Our work addresses issues including data ownership and publication rights, indemnification and insurance requirements, IRB and ethics committee considerations, informed consent frameworks, and compliance with FDA good clinical practice (GCP) regulations and HIPAA privacy requirements.
Illustrative Engagement: Series A for Diagnostic Platform Company
An early-stage molecular diagnostics company developing a novel point-of-care testing platform engaged Montague Law to serve as corporate counsel in connection with its Series A financing. Our team restructured the company’s IP assignment agreements with its university licensor to clarify field-of-use exclusivity, negotiated a $12 million Series A round with a life sciences-focused venture fund that included milestone-based tranche funding tied to 510(k) submission, drafted scientific advisory board agreements and consulting arrangements with key opinion leaders, and established a stock option plan designed to attract clinical and regulatory talent over the company’s anticipated three-year path to FDA clearance.
This illustrative engagement is a hypothetical composite and does not represent any specific client matter. It is provided to demonstrate the types of transactions Montague Law handles for life sciences clients.
Frequently Asked Questions
When should a life sciences startup engage legal counsel?
Ideally, before the company is formed. Many life sciences companies originate from university research, and the terms of the technology license from the institution set the foundation for everything that follows — including IP ownership, royalty obligations, diligence requirements, and sublicensing rights. Getting these terms right at the outset is far less expensive than renegotiating them later under pressure from investors or acquirers.
What is a milestone-based tranche funding structure?
In life sciences financings, investors frequently structure investments in tranches that are released upon the achievement of specific milestones — such as completion of a preclinical study, IND filing, enrollment of a clinical trial, or submission of a regulatory application. This structure allows investors to manage risk by limiting capital deployment until the company demonstrates progress, while providing the company with committed funding. Negotiating appropriate milestones and the consequences of milestone failure is a critical part of life sciences deal-making.
Does Montague Law handle FDA submissions directly?
We do not prepare or submit FDA applications — that work is handled by regulatory affairs professionals and consultants with deep scientific expertise. However, we advise on the legal and corporate dimensions of the regulatory process, including regulatory strategy as it affects corporate structure, financing, and deal terms. We work closely with our clients’ regulatory teams to ensure alignment between the legal and regulatory workstreams.
How are life sciences companies typically valued in M&A transactions?
Pre-revenue life sciences companies are typically valued based on the stage of their product development, the quality of their clinical or preclinical data, the regulatory pathway and timeline to approval, the size of the addressable market, and the strength of their intellectual property position. Risk-adjusted net present value (rNPV) models are commonly used, and transaction structures often include substantial earnout components tied to future regulatory and commercial milestones.