Tech & Sourcing @ Morgan Lewis

As part of our Spotlight series, Dennis C. Gucciardo, who counsels medical device manufacturers throughout the product lifecycle in the US Food and Drug Administration (FDA) regulatory context, shares insight into some important considerations when creating, reviewing, and implementing medical device product warranties.

Don Shelkey and Ben Klaber will present a continuing legal education (CLE) webinar on digital health transactions on September 14 at 1:00 pm ET.

The Biden administration issued a long-anticipated executive order on August 9 regarding US outbound investment in select technology and products with national security applications produced by “countries of concern.” Executive Order 14105 (EO) was released in conjunction with a corresponding Advanced Notice of Proposed Rulemaking (ANPRM) from the US Department of the Treasury (Treasury). Both these developments, while not yet effective, are critical to technology companies and investors, and the coming months will reveal the extent of the impact and the direction Treasury takes with its proposed regulations.

Morgan Lewis’s technology, outsourcing, and commercial transactions team often advises on transactions where there is some form of intellectual property being transferred from one party to another party. This may be due to a corporate transaction, a cooperation or joint venture arrangement, or some other form of commercial agreement.

While the regulatory landscape around artificial intelligence (AI) continues to evolve, navigating contractual arrangements and apportioning risk for the use of AI may seem like stepping into the unknown. In this blog post, we consider how a few familiar concepts within commercial contracts may be applied to the provision and use of AI tools as part of services.

The first half of 2023 was one of the most active six months for legislative and regulatory developments around artificial intelligence (AI). Our colleagues recently noted the European Parliament’s adoption of a draft AI Act as well as the significant activity in the United States related to regulating AI, both at the federal and state level. AI is also increasingly giving rise to data privacy concerns.

The EU-US Data Privacy Framework (DPF) became effective on July 10, and on the same day, the European Commission adopted an Adequacy Decision relating to the DPF, as a successor of the EU-US Privacy Shield. While only those companies subject to the jurisdiction of either the Federal Trade Commission or the US Department of Transportation are eligible to self-certify their compliance with the DPF, the scope of eligibility is likely to broaden in the future.

We recently wrote about the emerging trend of content moderation outsourcing. In this blog post, we turn our attention to another growing trend: legal process outsourcing.

Open-source software (OSS) representations and warranties are an integral part of the intellectual property (IP) representations and warranties in mergers and acquisitions (M&A) transactions and financings, as M&A transaction documents regularly include requests for a seller to represent and warrant that it has policies in place regarding the use of OSS, has provided such policies to the acquirer or investor, and has not deviated from such policies. These representations and warranties are important, but they are routinely and necessarily backstopped by the due diligence process.

In our prior post in this two-part series on less commonly discussed technology commercialization options, we addressed how open-source software (OSS) providers may make money on their products. In this Part 2, we’ll look at another technology commercialization strategy, white labeling.