By Driscoll R. Urgate, P.A.
Financing and exit transactions in the life sciences industry differ fundamentally from those in traditional technology or manufacturing sectors. Scientific risk, regulatory oversight, and intellectual property rights intersect at every stage of a company’s growth, from seed capital through commercialization and acquisition. Investors and acquirers do not simply value a company’s technology, they assess its regulatory posture, data integrity, and the duration and durability of its exclusivity.
This article explores how capital-raising and exit strategies in life sciences require a multidisciplinary approach that integrates corporate structure, intellectual property strategy, and FDA compliance. It provides information for executives and general counsel navigating venture financings, public offerings, and M&A exits, and offers practical steps for aligning legal and operational strategy to preserve and enhance enterprise value.
Read the full article on the Duane Morris website.
Vicki Norton to Speak at Personalized Cancer Vaccine Summit
Duane Morris Partner Vicki G. Norton, Ph.D., will be speaking at the Personalized Cancer Vaccine Summit in Boston on Thursday, November 20. She will be on the panel “Health Economics, IP & Early Access: Navigating Legal Grey Zones in the Race to Personalized Cancer Vaccines.” The panel will discuss:
- How emerging legal frameworks, such as Montana’s Right To Try, could impact patient access to unapproved personalized vaccines and what that means for regulatory strategy.
- Balancing IP protection vs. platform flexibility in an era where proprietary algorithms, tumor-specific libraries, and bioinformatic tools are central to value creation.
- The role of patent exclusivity, trade secrets, and data protection in enabling commercial viability for PCVs – especially when facing fragmented regulatory landscapes.
Replay: Wearables Webinar Series, Part 3: Product Liability and IP Strategies for Wearables
A replay of “Wearables Webinar Series, Part 3: Product Liability and IP Strategies for Wearables” is now available for viewing.
Wearables Webinar Series, Part 3: Product Liability and IP Strategies for Wearables
Duane Morris will host the third session of its Wearable Webinars Series, Product Liability and IP Strategies for Wearables, on Tuesday, November 4, 2025, 12:00 p.m. to 12:30 p.m. Eastern.
About the Program
As wearables continue to reshape industries—from healthcare to consumer tech—their legal implications are evolving just as rapidly. This session brings together three Duane Morris attorneys to unpack the challenges and opportunities companies face in this dynamic space. In the final installment of our series on wearable devices, Duane Morris partners will go over:
- Product Liability and Wearables – Sean Burke
- The wearable industry challenges traditional legal frameworks, creating uncertainty for companies navigating potential exposure to product liability litigation. Sean Burke will highlight key issues, emerging trends and strategies to mitigate risk.
- FDA Oversight of AI and Machine Learning in Medical Devices – Agatha Liu
- Agatha Liu, Ph.D., will cover how wearables with diagnostic, monitoring or therapeutic claims fall under the FDA’s software as a medical device framework, including predetermined change control plans, good machine learning practices and real-world performance monitoring of adaptive algorithms.
- Intellectual Property Strategies for Wearables – Jason Luo
- Jason Luo, Ph.D., will discuss patenting trends and strategies, including timing, jurisdictions and portfolio development, patentability requirements for software and AI, and post-allowance strategies and global due diligence.
About the Webinar Series
Over a series of three mini-webinars, Duane Morris attorneys will offer high-level guidance on current FDA regulations, cybersecurity and data privacy, and product liability and IP strategies for wearables.
About the Duane Morris Life Sciences and Medical Technologies Group
As biotech, biopharma and pharma companies develop new therapeutics, aligning legal strategies with development and commercialization goals throughout the extensive process of funding, R&D, clinical trials and market entry is imperative to a company’s strategy, success and growth. We assist clients in developing and implementing strategies to protect and expand their pipeline and maximize the benefit of their products to their target patient population.
Replay: Wearables Webinar Series, Part 2: Cybersecurity and Data Privacy Concerns for Wearables
A replay of “Wearables Webinar Series, Part 2: Cybersecurity and Data Privacy Concerns for Wearables” is now available for viewing.
Replay: Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables
A replay of “Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables” is now available for viewing.
Wearables Webinar: Cybersecurity and Data Privacy Concerns for Wearables
Duane Morris will host the second session of its Wearables Webinar Series, Cybersecurity and Data Privacy Concerns for Wearables, on Tuesday, October 21, 2025, from 12:00 p.m. to 12:30 p.m. Eastern.
About the Program
The growing popularity of wearable devices that track consumers’ everyday health has been good for business. It has also resulted in increased concerns from regulators regarding the privacy and security of the health data and other personal information collected and used by wearable technologies. In our second wearables webinar, Duane Morris partner Michelle Hon Donovan will discuss:
- Privacy legal compliance landscape under state and federal laws and regulations
- FDA cybersecurity guidance
- Federal and state breach notification laws
- Key takeaways and best practices for compliance
About the Webinar Series
Over a series of three mini-webinars, Duane Morris attorneys will offer high-level guidance on current FDA regulations, cybersecurity and data privacy, and product liability and IP strategies for wearables.
Upcoming Webinar Sessions:
November 4, 2025 – Product Liability and IP Strategies for Wearables
About the Duane Morris Life Sciences and Medical Technologies Group
As biotech, biopharma and pharma companies develop new therapeutics, aligning legal strategies with development and commercialization goals throughout the extensive process of funding, R&D, clinical trials and market entry is imperative to a company’s strategy, success and growth. We assist clients in developing and implementing strategies to protect and expand their pipeline and maximize the benefit of their products to their target patient population.
Commerce Department Singles Out Harvard for Bayh-Dole March-In Rights Enforcement
There has been much concern and discussion about Commerce Secretary Howard Lutnick’s recent letter to Harvard University indicating the U.S. government’s exercise of its “march-in rights” for government-funded research resulting in IP owned by Harvard under the Bayh-Dole Act. Under the Bayh-Dole Act, recipients of U.S. government research contracts can own any IP resulting from that research, but there are some out-licensing restrictions on that IP, including a requirement to achieve practical application of the subject invention, domestic manufacture, small-entity out-license preference and reporting of all commercialization activities, including the filing of patent applications.
Note: Co-author Ryan Smith previously worked in the technology transfer office of a major California university managing iEdison reporting of commercialization efforts to comply with the requirements of the Bayh-Dole Act.
Take Care When Paying Volume-Based Compensation to Sales Agents to Avoid Anti-Kickback Statute Violations
By Frederick R. Ball, Coleen W. Hill and Victoria (Tori) Hawekotte
Pharmaceutical and medical device companies sometimes compensate sales agents per volume sold. The Fifth and Seventh Circuits have indicated that a company may structure such arrangements without running afoul of the Anti-Kickback Statute (AKS). However, such arrangements carry risk of violating the AKS and should be structured with care.
Montana Set to Become a “Wild West” Hub for Experimental Medical Treatments and Therapies
By Vicki G. Norton, Ph.D., and Brandon A. Chan Ph.D.
The Federal Food, Drug and Cosmetic Act generally prohibits access to investigational drugs that have not yet been approved by the United States Food and Drug Administration. Patients that have been diagnosed with a life-threatening or seriously debilitating disease may request “expanded access” or compassionate use to gain access to investigational drugs pending FDA’s permission. Right-to-try laws seek to bypass the FDA’s more rigorous requirements for expanded access and permit terminally ill patients to access investigational drugs, biologics and devices that have completed Phase I but have yet to receive FDA approval. Today, most states have enacted some form of a right-to-try law, and a federal Right to Try Act was enacted in 2018. Recently, Montana has sought to further expand access to experimental treatments.