The FDA recently released a new guidance, New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers, which the FDA plans to update with additional Q&As as appropriate. As referenced...more
Key Takeaways - FDA explains what must be “new” to qualify for three years of non-patent market exclusivity. In a new draft Q&A guidance, FDA walks sponsors through what makes a clinical investigation “new,” how to support...more
FDA recently published a new draft Guidance for Industry titled “New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers” (Mar. 2026) (the “Draft Guidance”). The Draft Guidance...more
Thinking about buying or selling a Texas business? You'll need to negotiate a letter of intent before drafting the purchase agreement. Here’s what many business owners do not realize: certain provisions in a letter of...more
The French Competition Authority (FCA) has fined Doctolib a total of EUR4.7 million for abusing its dominant position in the markets for online medical appointment booking services and remote medical consultation technology...more
In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and in some cases...more
Following the recent decision in Rivas v. Benny’s Prime Chophouse, where the Illinois Appellate Court allowed a civil claim to proceed despite arguments that the Illinois Workers’ Compensation Act (“Act”) barred recovery, the...more
Pickleball isn't just the weekend hobby your neighbors play anymore, it's blowing up! From local parks to sold-out arenas, it's now one of the fastest-growing sports in the United States. Courts are packed, tournaments are...more
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
Nature of the Case and Issue(s) Presented: FDA refused to approve Liquidia’s drug product, Yutrepia because another company, UTC, maintained marketing exclusivity. Liquidia sued FDA, and UTC intervened. The court granted...more
A letter of intent (LOI) or term sheet tends to be the first substantive document for an M&A transaction. It outlines the key terms and mutual understanding between a buyer and seller while they progress through due diligence...more
Virtually every bank’s form lending program agreement we’ve negotiated for our fintech clients has come with an exclusivity provision. The bank’s policy behind them is simple: We’ve put in the time, effort, expertise...more
Negotiating and signing a Letter of Intent (LOI) is a key inflection point in the process of selling your business. Buyers and sellers both want the LOI to ensure a base level of understanding on certain key terms such as...more
Earlier this year, firm Associate Darden Copeland attended The Racing Attorney Conference (TRAC) for its 15th annual conference at Circuit of the Americas in Austin, Texas. ...more
On January 9, the U.S. Department of Labor issued its Final Rule addressing how to determine whether a worker is properly classified as an “employee” or as an “independent contractor” under the Fair Labor Standards Act. ...more
In the aftermath of a 2018 U.S. Supreme Court ruling that repealed the federal ban on state-sponsored sports wagering, the sports wagering market has proliferated across the United States at an expedited pace. Since the...more
Influencing has grown to a $21 billion industry. In response to the rapidly growing ubiquity of influencer-driven marketing, the Federal Trade Commission (FTC) has published numerous guidelines for influencers and advertisers...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
If you are like most wine brands, DTC through your tasting room, club, and website can only take you so far. Success usually means accessing the general on- and off-premise markets, and accessing those markets means working...more
In our last installment, we discussed some of the initial steps involved in the process of selling a dental practice, including preparing your practice for sale and finding a potential suitor. Specifically, we described ways...more
Integrated Marketing Promotions: How Do Brand Tie-Ins Work? I’m a Skipper in a Barbie world. Even if the brunette little sister doesn’t make an appearance, I can’t wait to see the Barbie movie this weekend. Warner Bros....more
In 2022, the influencer marketing industry was valued at US$16.4 billion, and that number is expected to grow to US$21.1 billion by the end of 2023. For brands who have not yet taken advantage of marketing through influencers...more
Market conditions suggest that the trend toward longer durations will continue in 2023. Amid the current economic uncertainty, many PE buyers are taking extra precautions to ensure that the deals they pursue will deliver...more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
Last week, the Court of Appeals of Virginia rendered a significant opinion regarding the meaning of exclusivity required for claims of adverse possession. In Veldhuis v. Abboushi, Record No. 0776-22-4 (Ct. App. Va. May 9,...more