Life Sciences and Healthcare

For private companies backed by venture capital investors, acquisition is frequently the most likely path to liquidity. Founders are often laser-focused on product development, market expansion, and fundraising, without devoting the same early-stage discipline to ensuring the company is well-positioned for a future exit via a merger or acquisition.

M&A preparedness is not a late-stage exercise, but an operational strategy to position your company as an attractive, high-value target to potential acquirors.

Corporate Governance

Some of the most common obstacles to efficient M&A processes stem from issues related to corporate governance. Complex capitalization tables, unclear chain of equity ownership, and unresolved governance issues can create transaction delay and, depending on the structure of the transaction, loss of leverage.

Companies should consider focusing on three key areas of corporate governance to be prepared for future M&A processes: capitalization table discipline, stockholder rights, and board and stockholder alignment.

Capitalization Table Discipline

Maintain clear documentation of all equity issuances with proper board and stockholder approvals; confirm board minutes are complete, approved by the board, and signed; verify that 83(b) elections have been timely filed with respect to restricted stock grants to founders and early employees; and ensure 409A valuations are updated following major events that may impact valuation (such as a financing) and, absent such events, at least annually.

Stockholder Rights

Ensure all stockholders have signed the relevant stockholder agreements and that the company’s management team understands the protective provisions embedded within such agreements; similarly, ensure that the company’s management team is familiar with relevant provisions of any investor side-letters (think drag-along mechanics, rights of first refusal, and co-sale rights).

Board and Stockholder Alignment

Understand what approvals are required to approve a sale or merger of the company and whether any investor has blocking rights.

Contracting Discipline

Material contracts, such as key vendor and customer agreements, collaboration agreements, and licensing arrangements, are some of the first diligence requests in an M&A process. These contracts often contain assignment or change-of-control provisions that can require third-party consent, accelerate payment obligations, or trigger termination rights or other contractual rights that could significantly impact the trajectory of a deal. Accordingly, it is important for companies to maintain clear records of all material contracts, ensuring that all contracts are fully executed and include all attachments, exhibits, amendments, and restatements. Companies should track whether any material contracts have upcoming renewals or expiration dates. Additionally, tracking key provisions in such material contracts that may be triggered by an M&A (such as third-party consent requirements) will help streamline the M&A diligence and consent process.

Intellectual property is another value-driver for life sciences companies and technology companies, making it vital for companies to have documentation that clearly delineates intellectual property ownership. Companies should verify that all employees and contractors have signed Proprietary Information and Inventions Assignment Agreements (PIIAAs), review consulting agreements to confirm that intellectual property created by consultants/contractors has been validly assigned to the company, and obtain confirmatory assignments from founders and early contributors, if needed, and at the appropriate time. For companies with affiliated entities, confirm that the company’s core intellectual property assets sit within the target entity and not within any affiliated entities.

Being proactive can save time and expense during the M&A diligence process.

Regulatory Compliance

Depending on industry and geography, regulatory risk can become a gating diligence issue. Companies should identify areas of risk and preemptively resolve any outstanding compliance risks (e.g., data integrity, marketing, industry-specific licensing, etc.). In particular, life sciences companies should consider pursuing regulatory planning with the assistance of healthcare and/or FDA counsel (as needed) to ensure, among other things, that regulatory filings, communications, and approvals are complete and accessible.

Deal Team Preparation

Once the company has decided to start a sale process, identify at the outset who will be part of the core deal team, which will typically consist of a select number of employees and outside advisors. Members of executive management and other key internal personnel with specialized knowledge about the company’s corporate governance, labor and employment practices, employee benefits structure, assets (IP, real estate, etc.), litigation exposure, and regulatory compliance are typically included within the core deal team. Further, at the appropriate time, companies should engage outside advisors, such as outside legal counsel, financial/tax advisors, and investment bankers, all of whom can help quarterback the transaction and efficiently drive the deal process.

After the deal team is in place, consider implementing deal confidentiality procedures to maintain the integrity of the sale process:

• assign code names to the project and company participants;
• limit working group size and access; and
• consider antitrust issues and the use of “clean team” agreements and data rooms.

Data Room Readiness

Prepared companies treat diligence readiness as an ongoing process and not an exercise triggered by a letter of intent or term sheet. First, select a virtual data room that provides strong security and activity tracking. Second, build the company’s data room with organizational discipline, using logical folder structures (corporate, IP, finance, regulatory, benefits, etc.) and uploading documents in a searchable, digital format with consistent document naming conventions. Lastly, in connection with building the data room, flag with the guidance of deal counsel any confidentiality concerns and access restrictions that need to be put in place. For example, are there any documents that need to be redacted or anonymized? Does the transaction present antitrust sensitivity requiring documents to be shared through a “clean room”?

In all, a well-maintained and categorically organized data room significantly accelerates a sale process and signals sophistication to potential acquirors.

The most successful exits rarely begin when a banker is engaged. Ideally, they begin years earlier with strategic and operational foresight. Companies that understand the value of M&A preparedness can preserve negotiation leverage and act more decisively when M&A opportunities arise. After all, engineering an exit is more than closing a deal — it is positioning the company so that the right deal finds you.

The U.S. Food and Drug Administration is deepening its own use of artificial intelligence. Less than a year after launching its internal AI tool, Elsa, the agency released Elsa 4.0 and connected it to a new unified data platform that pulls together roughly 40 previously separate systems, so staff can query agency data directly instead of uploading documents each time. New features include custom AI agents, document generation, data analysis and visualization, and better search. FDA says humans stay involved at every step and that the model is not trained on data submitted by regulated companies.

On the same day, the then-Commissioner announced a pilot of “one-day inspections” for facilities that AI-driven risk analysis flags as lower risk. These are short screening visits meant to supplement, not replace, full inspections. More than 40 have been completed since April 2026, mostly ending with no action indicated, though inspectors can still issue formal observations and can expand the visit on the spot. Companies are not told in advance whether they are in the pilot, so life sciences startups with manufacturing or clinical sites should stay ready for either format. Complex or higher-risk operations, such as sterile manufacturing, remain on the standard inspection track.

The Court of Justice of the European Union has clarified whether a health-related product counts as a “medical device” in the EU, which determines whether the heavy compliance obligations of the Medical Devices Regulation apply. In Case C-427/24, Diagramm Halbach, the Court held that the analysis has two parts: what the manufacturer says the product is for, drawn from labeling, instructions, and marketing, and whether the product objectively performs one of the specific medical functions the regulation lists, such as diagnosis, monitoring, or treatment of disease. Marketing claims should not be considered in isolation and may not pull a product into the regime if it does not actually perform a medical function, and equally a company cannot avoid the rules by staying quiet about an obvious medical use. For founders building software or AI-enabled health tools, the ruling sharpens the line between administrative or organizational features and functions that genuinely inform clinical decisions, and that distinction determines whether CE marking and conformity assessment are required before selling in the EU.

AI is reshaping drug discovery and development by accelerating research timelines, optimizing clinical strategies, and improving manufacturing efficiency, but adoption brings a complex web of legal considerations that life sciences companies must navigate. This article, published in Drug Discovery World, examines regulatory pathways for AI-assisted drug development, intellectual property ownership challenges, and data protection and privacy obligations arising from AI model training, and outlines practical steps organizations can take to capture the benefits of AI while managing regulatory, IP, and contractual risks.

Despite cautious optimism following an upturn in biotech M&A in mid-2025, development-stage biotech companies continue to face significant financial headwinds including increased layoffs, higher borrowing costs, healthcare pricing reforms, and ongoing market correction following the pandemic-era investment boom. Companies should take proactive steps to build financial resilience: routinely identifying clinical and regulatory inflection points that could threaten liquidity; maintaining robust contingency plans that account for insolvency regimes in all relevant jurisdictions; engaging in fact-finding during periods of financial health to identify potential cash shortfalls; evaluating hypothetical liquidation scenarios early to understand timing and resource requirements; running structured strategic alternative processes (including asset sales, mergers, or licensing deals) well before reaching a crisis point; and budgeting for the time and cost of navigating financial distress, including the reality that dissolution processes can take three or more years to complete.

Federal health regulators settled four ransomware investigations on April 23, 2026, with a health provider network, an imaging provider, a third-party benefits administrator, and a self-funded health plan. Together the breaches exposed health and financial data for more than 427,000 people, and the companies agreed to pay a combined US$1,165,000 and to follow corrective plans monitored for two years. The common thread was not how the companies responded after the attacks but what they had failed to do beforehand: none had a complete, current assessment of where sensitive health data lived, how it moved through their systems, and what could go wrong.

For a startup handling health data, or acting as a vendor to one, the practical signal is that regulators are judging security preparation, not just incident response. Expectations include an up-to-date inventory of systems and data flows, encryption, multi-factor login, logging, vulnerability scanning, and training. Pending amendments to the HIPAA Security Rule would make many of these steps mandatory, with roughly 240 days to comply once finalized.

IP will be a core focus for a biotech company and its investors through its entire lifecycle. While the company’s IP strategy can and should evolve over time, there are certain steps that an early-stage company can take at the outset to establish a strong foundation. This article identifies several key principles that, in addition to an intelligently crafted IP portfolio, will help set an emerging company up for future success.

Document Ownership

Too many deals — licenses, acquisitions, or otherwise — stumble due to questions about ownership of a company’s core inventions. Fortunately, a few simple documents can avoid most issues. Founders and other employees should have straightforward agreements assigning (using “present tense” assignment language) relevant inventions to the company. Companies should also understand whether key personnel have parallel or prior obligations to academic institutions, and be able to clearly explain those obligations, and ensure that CROs, consultants, and other service providers also appropriately assign IP generated for the company.

Document these arrangements when relationships begin — not several years later when an investor or potential acquirer asks for the paperwork and it may be logistically difficult or expensive to reconstruct a chain of title for IP.

License for the Long-Term

When a company is in its very early stages, there can often be a lot of time pressure to secure any third-party IP rights, such as a foundational IP license from a university. It is also important, however, to keep in mind that licenses are long-term instruments and the same document may be scrutinized several years later in a due diligence process when the company’s situation is very different. While perfection can often be the enemy of good, foresight does not have to be the enemy of speed. Negotiating the material license or collaboration with an eye towards future-proofing in a few key areas can even increase the value of the agreement to the company.

Patent then Publish

Once out of stealth, scientific publications, conference presentations, and other disclosures can be integral to a young biotech company’s success. They can also have irreversible consequences for patent protection if not timed properly — i.e., a publication prior to patent filing can preclude the issuance of the patent.

Early training for employees and a simple process can go a long way in mitigating this risk. A one- or two-hour IP 101 training from counsel can be very effective, and can also roll out a straightforward process to ensure that both technical and other personnel know to check with patent counsel before submitting a manuscript for publication or disclosing proprietary information in a pitch without a confidentiality agreement in place.

The rule of thumb is simple: when potentially patentable technology is about to leave the building, determine whether to file a patent application first.

Joint Ownership Does Not Simplify

Negotiating a transformative IP agreement can sometimes take considerably longer than initially thought, and it can often be tempting to take the negotiation path of least resistance. When it comes to IP ownership, this path equates to “joint ownership” of inventions. On its face, joint ownership sounds like a great solution. It is fair, equitable, and does not require a complex analysis of each party’s contributions to the invention. It is jointly owned, no matter what. The problem lies in operationalizing the joint ownership.

The rules governing jointly owned IP vary by jurisdiction and can create complications around licensing, patent prosecution, enforcement, and commercialization. Joint ownership can also become particularly cumbersome in future transactions — e.g., an acquirer is a competitor of a joint owner. While it may take a little extra negotiation, there are many ways to allocate ownership of IP other than just inventorship that can suit both parties, including ownership based on relation to background IP, subject matter, or type of IP.

Data Is a Key Asset

A biotech’s most valuable assets increasingly extend beyond patents and traditional know-how. Preclinical results, clinical data, biomarker datasets, manufacturing data, and datasets used to develop or validate computational tools may all have substantial strategic value. Data rights and restrictions should be given the same level of focus as the development of an IP strategy. Particular attention should be paid to distinctions among raw data, processed data, derived data, and analytical outputs — and to privacy, consent, or contractual restrictions that may constrain future uses.

With sweeping cuts to federal research funding driving academic scientists in the life sciences toward entrepreneurship, there are practical steps for navigating this transition: adopting an entrepreneurial mindset that embraces risk and redefines success; leveraging university incubators, tech transfer offices, and alumni networks; broadening professional networks through industry events and mentorship; validating ideas through market research and minimum viable products; understanding regulatory pathways and engaging FDA-specialized counsel early; learning intellectual property fundamentals and working with IP attorneys to build a competitive strategy; developing a comprehensive business plan with milestones and financial projections; securing a diverse mix of funding from grants, angel investors, and venture capital; assembling a multidisciplinary team with complementary expertise; and launching pilot projects to demonstrate feasibility and build credibility with investors and partners.

The UK’s Medicines and Healthcare products Regulatory Agency moved on several fronts in the first half of 2026, with the intention of developing a more innovation-friendly and AI-aware regime. The developments include a landmark program deepening regulatory cooperation between the UK and the United States, a regulatory “sandbox” for AI used as a medical device, meaning a supervised space where companies can test products with the regulator before full authorization, an evidence-gathering exercise on how AI in healthcare should be regulated, a consultation on a draft Rare Disease Therapies Regulatory Framework, and the largest package of UK clinical trial reforms in more than twenty years. For a founder building AI-enabled diagnostics, software, or therapeutics, this changes both the route to market and its timing: earlier regulator engagement is becoming possible, trial rules are being streamlined, and closer UK-US alignment may reduce duplicated work across the two markets.

In an article for Life Science Leader, partners Sally Wagner Partin, Sharon Flanagan, and Torrey Cope examine how artificial intelligence is reshaping life sciences M&A by changing the pace and economics of drug development. They explore how AI’s growing role in target identification, clinical development, and regulatory decision-making is influencing valuation, due diligence, milestone structures, transaction timing, and risk allocation, and outline key considerations for dealmakers as AI continues to transform the life sciences industry.