Defense Contractors’ Restrictions When Contracting with Chinese Companies
In the current economic climate, the obvious focus of many companies is on the administration’s imposition of tariffs. However, government contractors, especially those contracting with the U.S. Department of Defense (“DoD”), must not lose sight of their current and potential future direct and indirect relationships with certain Chinese entities.
Contractors’ compliance obligations regarding relationships with Chinese entities flow from:
FAR 52.204-25 (Section 889 of the 2019 National Defense Authorization Act (“NDAA”)), and
The Chinese Military Companies (“CMC”) List (Section 1260H of the 2021 NDAA) (also known as the “1260H List”).
Section 889 became effective in 2019 and 2020, so compliance policies and procedures applicable to contracting with all federal government agencies should be well in place. New complexities are emerging for defense contractors given the expanding number of Chinese entities on the1260H List. All contractors are required to annually certify compliance with Section 889, but defense contractors will have an additional level of compliance. They will be required to comply with the 1260H List beginning in June 2026 (for contractors that work with individuals or entities that lobby for CMCs) and June 2027 (for contractors sourcing from or otherwise doing business with entities on the 1260H list). We discuss both compliance frameworks below and provide several key takeaways for contractors.
Government-Wide Supply Chain Restrictions: Section 889
Parts A and B of Section 889 impose significant restrictions on a contractor’s ability to use and sell to the government covered telecommunications and video surveillance products and services (“covered equipment and services”) from five Chinese entities and their affiliates.
Part A, effective August 2019, prohibits the government from procuring covered equipment and services manufactured by the companies identified below. A prime contractor is required to flow down this prohibition to its subcontractors. Part B, effective August 2020, prohibits the government from contracting with entities that “use” covered equipment and services from the five identified companies. This prohibition applies to a contractor’s use of covered equipment and services in any part of its business. There is no nexus required tethering the use of such equipment or services to the contractor’s performance of a federal government contract. Part B does not flow down to subcontractors.
As U.S. government contractors are now well aware, compliance with Part B requires eliminating covered technology and services from their organizations from the five named Chinese entities and their affiliates, which typically include the following types of products/services:
Huawei: mobile phones, laptops, tablets, routers, and switches
ZTE Corporation: mobile phones, mobile hotspots, and network equipment (routers/switches)
Hytera Communications Corporation: radio transceivers and radio systems
Dahua Technology Company & Hangzhou Hikvision Digital Technology: video surveillance products and services (e.g., company surveillance systems)
DoD-Only Relationship Restrictions on Companies Listed on the Section 1260H List
The 2021 NDAA will add a second layer of compliance only for defense contractors. The Secretary of Defense is required to publish an annual list of CMCs. Starting in June 2026, DoD will be prohibited from procuring goods, services, and technology produced or developed by listed CMCs or companies that hire lobbyists that lobby for CMCs. Starting in June 2027, the same prohibition will apply to indirect procurements, meaning defense contractors must eliminate goods, services, and technology from listed CMCs from their supply chains.
To be included on the 1260H List, a Chinese entity must have one of two associations as determined by DoD. First, an entity must directly or indirectly (whether through ownership, control, or affiliation) act as an agent of the People’s Liberation Army; Chinese military or paramilitary elements; security, police, law, or border enforcement; the People’s Armed Police; the Ministry of State Security; or any other organization controlled by the Central Military Commission of the Communist Party, the Ministry of Industry and Information Technology, the State-Owned Assets Supervision and Administration Commission of the State Council, or the State Administration of Science, Technology, and Industry for National Defense. Alternatively, listed entities are those important to civilian and military advancements in China’s defense industrial base; these entities are called “military-civil fusion contributors.”
Whereas compliance regimes for Section 889 are nearly five years old, compliance deadlines for Section 1260H are upcoming:
Starting June 30, 2026, DoD may not (i) enter, renew, or extend contracts for goods, services, or technology with listed entities or their affiliates, or (ii) contract with companies that engage individuals or entities that lobby for CMCs, even if regulated “lobbying” activity does not relate to the contractor’s operations (Section 851 of the 2025 NDAA). (“Lobbying” is defined by the Lobbying Disclosure Act of 1995).
The prohibition differentiates between end-item technology and mere “components” of end item technologies. The prohibition focuses on end-items. (“Component” means an item supplied to the Federal Government as part of an end-item or of another component. 41 U.S.C. § 105.)
Starting June 30, 2027, DoD may not purchase end products or services developed or produced by listed entities indirectly through third parties. (Note an exception in Section 805 of the 2025 NDAA excluding the purchase of component materials that are part of an end product created by an entity not on the 1260H list.)
Section 1260H of the Fiscal Year 2021 NDAA required that DoD publish the 1260H List each year until at least 2030. Additional entities have been added each year thereafter. In an effort to provide contractors with ample notice, DoD has begun publishing 1260H Lists. As of January 2025, there are 134 entities on the list (Notice of Availability of Designation of Chinese Military Companies (Federal Register)). The listed entities span an array of industries, including telecommunications, aerospace, semiconductors, artificial intelligence, energy, and transportation, among others. Notably, Hangzhou Hikvision Digital Technology Co., Ltd. (Hikvision); Huawei Technologies Co., Ltd.; and Zhejiang Dahua Technology Co., Ltd. (Dahua) appear on both the Section 889 and Section 1260H lists.
Key Takeaways for Contractors
For Section 889 and Section 1260H compliance, U.S. government contractors must assess their supply chains both for direct contracts as well as contracting for end products or services developed or produced by listed entities indirectly through third parties on either list.
For purposes of Section 1260H, contractors must assess whether existing sourcing relationships involve “components” of end items (which are exempted) or end items themselves.
Further, contractors must conduct extensive due diligence to understand the agents working with them and on behalf of any listed entity to avoid running afoul of the restrictions on lobbying activity.
Contractors should actively monitor this space because more stringent restrictions may follow.
What Every Multinational Company Should Know About … Customs Enforcement and False Claims Act Risks (Part II)
As detailed in Part I of our three-part series on Minimizing Customs Enforcement and False Claims Act Risks, the combination of the new high-tariff environment, the heightened ability of Customs (and the general public) to data mine, and the Department of Justice’s (DOJ) stated focus on using the False Claims Act (FCA) substantially increases import-related risks. In light of this heightened risk, Part II and the forthcoming Part III of this series focus on preparing for specific areas where we see heightened enforcement risk, both for Customs and FCA penalties, with this article addressing the most common FCA risks arising from submitting false Form 7501 entry summary information.
Risks Arising from Misclassifications
By far, the most common Customs errors we see relate to misclassifications on Form 7501 entry summaries. If made knowingly, these misclassifications can lead to FCA liability, as demonstrated by a high incidence of DOJ settlements based on alleged known classification errors. Relevant FCA examples include $22.2 million and $2.3 million settlements, each premised on importers knowingly misclassifying entries into lower-tariff classifications to avoid paying duties owed on the companies’ imports.
Additionally, aggressively classifying goods to avoid being subject to the China Section 301 tariffs can create the risk of FCA liability. Such opportunistic classification led to a $22.8 million settlement by an importer that used inaccurate classifications despite receiving repeated CBP notices informing the importer that the classifications it had been using for similar goods were erroneous. The importer continued using the incorrect classifications for over three years, even after an outside consultant confirmed the importer had been using incorrect classifications.
Customs Compliance Response
Maintain a Regularly Updated Classification Index. Well-supported and consistent classifications are the key to avoiding these types of errors. The most important tool for ensuring accuracy in classifications is a robust and regularly updated Customs Classification Index, which should list the HTS classification for regularly imported SKUs while incorporating support for classification decisions made, including an application of the Customs General Rules of Interpretation, advisory opinions, responses to protests against liquidation, and other relevant support.
Conduct Classification Reviews. We often find that importers leave classification decisions up to customs brokers, assuming they are experts and responsible for identifying the correct codes. Customs, however, places full responsibility for the accurate submission of all Form 7501 information on the importer of record, not the broker. Periodically review your classifications, especially for frequently imported items, to ensure accuracy.
Evaluate Classification Accuracy in Post-Entry Reviews. Customs allows importers 310 days after entry to fix any classification errors. Conduct post-entry checks to confirm the accuracy of all submitted information, and use post-summary corrections to correct any errors, including misclassifications, before liquidation. This will help catch errors and, where corrected, undermine FCA scienter.
Review Tariff Engineering. With tariff rates rising, Customs is aggressively looking for importers who have engaged in opportunistic classification to try to lower import charges. This includes a special focus on importers who have changed their classifications after the imposition of new tariffs. This does not mean importers should view themselves as locked into adverse and incorrect classifications. They should, however, adequately document any classification changes and be prepared to respond promptly to Customs inquiries.
Risks Arising from Misrepresenting the Physical Characteristics of Imported Goods
Making known misrepresentations to incorrectly claim a lower tariff classification can lead to FCA liability. For instance, an importer of brake parts settled an FCA case alleging it knowingly misrepresented the physical characteristics of its entries (claiming they were duty-free unmounted brake pads rather than mounted brake pads subject to a 2.5% classification) for $8 million.
Customs Compliance Response
Confirm Accuracy of Factual Support for Classifications. In most cases, classification is determined by (1) the physical attributes of the product and, in certain cases, (2) the primary use of the product. Ensure you have accurate backup and consistent classification for each of these issues.
Document and Retain Classification Decisions. Ensure you maintain detailed records for all classification determinations, and keep them for at least five years from the time of entry.
Risks Arising from Improper Country of Origin Declarations
Because of the imposition of special Section 301 tariffs on China, the number of importers caught making errors relating to declaring the wrong country of origin (COO) has sharply risen. The imposition of reciprocal tariffs only magnifies the importance of the COO. Generally these cases involve imported goods that were assembled in third countries using parts and components from a high-tariff country. In these situations, careful analysis is required to ensure there is sufficient manufacture, value added, and change in the name, character, and use of the product so the result is a “substantially transformed” product that is a new and different article of commerce.
FCA cases illustrate the twin risks that can arise from incorrect COO declarations. In 2021, the DOJ settled an FCA matter for $160,933, alleging the importer knowingly failed to designate that certain imports were manufactured in China, thus evading Section 301 duties.
Customs Compliance Response
Confirm Accuracy of Substantial Transformation Analysis. One of the highest-priority areas of Customs scrutiny is to find instances of importers evading customs duties either by transshipping through lower-tariff third countries or by shipping parts and components to a third country and then engaging in only minor assembly operations (e.g., from China to another Southeast Asia country). If the goods are not substantially transformed into a new and different article of commerce, then they cannot claim the lower-tariff COO. Review all instances where parts and components from a high-tariff country, like China, are used in further manufacturing in a lower-tariff country. Ensure there is a reasonable basis for the COO declaration, and document the analysis in case of Customs inquiry.
Risks Arising from Undervaluation
Failing to declare the full value of entries is another common error. Most importers use transaction value, which requires the importer to start with the price actually paid or payable, add certain mandatory additions (e.g., the value of assists and royalties), and accurately reflect any allowed voluntary deductions. Recent examples include $217,000, $729,000, and $1.3 million settlements of allegations relating to known under-declared entry values resulting in underpaid tariffs, as well as a $3.6 million settlement of civil claims resulting from the DOJ joining an FCA whistleblower lawsuit. An additional sobering example is a settlement of claims against an importer that knowingly undervalued its goods through the remedy of losing all import privileges.
More specifically, the known failure to include assists (i.e., customer-provided production aids such as tools, dies, and molds) within the entered value can incur FCA liability. Where a U.S. company provides such assists, it needs either to declare the full value of the assist on the first entry or set up a system to attribute the full value of the assist over the useful lifetime of the product, thus declaring it piecemeal over time. These values do not show up on commercial invoices, making it easy to forget to include this mandatory addition to entered value. But the risks of knowingly failing to do so are demonstrated by two FCA settlements of $4.3 million and $7.6 million for the alleged failure to include assists in the entered value.
Customs Compliance Response
Understand How to Calculate Entered Value. Most companies use transaction value to determine the entered value. Valuation is complicated in situations involving post-entry price adjustments, cash or quantity discounts, indirect payments, exchange rate conversions, and other tricky areas. Ensure valuation is calculated correctly for all entries, including for the inclusion of off-invoice mandatory additions to value.
Establish a System for Identifying and Tracking Assists, and Consistently Follow It. Importers should have a system for systematically identifying and tracking assists, which can be as simple as a spreadsheet. If this historically has not been done, a review of a company’s trial balance ledger can potentially identify historically provided assists. All assists either should be recognized on the first entry of the applicable universe of goods or apportioned over the expected useful lifetime of the assist. If the latter method is used, establish a system for tracking all relevant entries benefiting from assists and consistently add them when calculating the entered value. Share such information with your customs broker to implement a secondary check.
Risks Arising from Improper Claims of Preferential Treatment Under Free Trade Agreements
Another common error we see is failing to meet free trade agreement (FTA) requirements, such as failing to work through the COO requirements. Along these lines, in one FCA action an importer paid $22.2 million to settle allegations that, among other things, it knowingly claimed improper preferential treatment under FTAs.
Customs Compliance Response
Always Have Certificates of Origin On Hand at Time of Entry. One of the most common errors we see in customs audits and disclosures is one of the simplest to fix: Ensure that you always have the USMCA certificate of origin available at the time of importation. Under the USMCA, it is not possible to create these after the time of entry.
Apply Correct Country of Origin Principles. FTAs include different COO principles. These generally are based on a tariff-shift analysis, which is viewed as providing more certain outcomes than the more subjective substantial transformation test commonly applied by Customs. Certain products, such as automotive products under the USMCA, also have special rules for determining preferential status. Note as well that it may be necessary to apply FTA principles to determine the COO for purposes of paying normal Chapter 1-97 duties while applying substantial transformation principles for determining the country of origin for special tariffs, such as section 232 or 301 tariffs imposed by President Trump.
Risks Arising from Failure to Pay Antidumping and Countervailing Duty Orders (AD/CVD Orders)
In addition to the normal Chapter 1-97 tariffs, the U.S. government imposes a parallel set of duties under more than 600 AD/CVD orders. Because AD/CVD tariffs often are very high, failure to properly declare and pay all AD/CV duties can quickly run up tariff underpayments.
As a result, one of the most common Customs FCA claims is for failing to pay AD/CV duties. An importer of home furnishings agreed to pay $500,000 to resolve allegations that it violated the FCA by knowingly making false statements on customs declarations to avoid paying AD duties on imports from China, with four other importers agreeing to pay $275,000, $5.2 million, $10.5 million, and $15 million based on alleged known classification failures based on the same order. Three other importers paid settlements of $2.300,000, $650,000, and $100,000 to settle allegations that they had knowingly evaded AD duties under the aluminum extrusions AD duty order, while another paid $45 million to resolve allegations that it knowingly misrepresented the COO to evade AD/CV duties.
Customs Compliance Response
Use HTS Screening. The scope of an AD/CV duty is determined by its written scope, not whether it falls within any given HTS subheading. Nevertheless, every order provides HTS subheadings for the convenience of importers. Screen all entries against these HTS subheadings as an initial check, and follow up on any potential matches.
Be Wary of Counter-Intuitive Coverage of AD Duty Orders. Be aware that certain AD/CVD orders, such as the aluminum extrusions order against China, are not susceptible to HTS screening and require individual examination. Also, consider that certain AD duty orders, such as the one on solar panels, have tricky rules for determining the product scope. Learn which orders are of particular relevance for your import profile and carefully screen all potential matches against them.
Risks Arising from Misapplying Customs Duty-Free Exemptions
A number of Customs programs can result in duty-free entries, such as U.S. goods returned and the Generalized System of Preferences. Illustrating the risks inherent in misapplying duty-free exemptions, importers paid $610,000 and $908,100 to settle allegations that involved “improperly evad[ing] customs duties … breaking up single shipments worth more than those amounts into multiple shipments of lesser value in order to avoid the applicable duties.”
Customs Compliance Response
Carefully Confirm Eligibility Under All Tariff-Saving Programs. Each tariff-saving program has its own rules, which can include special eligibility requirements. Carefully review these rules and document their applicability before claiming preferential treatment.
Risks Arising from Failure to Appropriately Value Goods from Related Parties
Another common problem is that importers either do not have a transfer pricing study in place to support the arms-length nature of their pricing when purchasing from affiliates, or they improperly rely on an IRS transfer pricing study (which is impermissible because CBP has specific standards for transfer pricing studies that differ from the IRS standards). Although we are not aware of any FCA case alleging improper pricing from related parties, this conduct is common and can potentially impact a large volume of entries, making a known misdeclaration a risk factor for potential FCA liability.
Customs Compliance Response
Confirm the Existence of a Customs-Specific Transfer Pricing Study. If you do not have a customs-specific transfer pricing study in place, consider conducting or hiring a customs accounting specialist to prepare a bridge memorandum to analyze the underlying data. If you do not have an IRS transfer pricing study, then obtain one (and also take care of your IRS transfer pricing requirements).
Confirm the Consistent and Accurate Application of the Results. It is important not only to have a customs transfer pricing study but also to consistently apply its results. Ensure the entered value from every import from a related party is confirmed against the conclusions of the study.
In sum, DOJ has a rich history of using a wide variety of issues to support FCA claims, especially relating to the known false submission of Form 7501 entry summary information. By considering the compliance responses outlined above, importers can ensure that their entry summary information is accurate in the first place, to best avoid known false submissions. Part III of this series will turn its focus to FCA risks arising from improper management of import operations.
Drug Pricing and Payment Executive Order Shows Trump Administration’s Cards
On April 15, 2025, President Trump signed the Lowering Drug Prices by Once Again Putting Americans First Executive Order (Executive Order). The Executive Order revives and expands several pharmaceutical pricing and payment reforms from President Trump’s first term, with a goal of curbing drug costs to patients. This offers a highly anticipated glimpse into the Administration’s position on drug manufacturers, Pharmacy Benefit Managers (PBMs) and providers.
Notably, the Executive Order endorses reforms to the Inflation Reduction Act (IRA), including the Medicare Prescription Drug Negotiation Program and the so-called “pill penalty.” The Executive Order also looks to expand on reimbursement reductions for hospitals that are critical participants in the drug supply chain. Below is an analysis of the Executive Order’s key components, including potential impacts and 340B Drug Pricing Program (340B Program) considerations.
1. Reforming Medicare Drug Price Negotiations under the IRA
The IRA, signed into law in 2022, included several provisions aimed at lowering prescription drug prices. One of the primary provisions in the IRA was the expansion of Medicare’s ability to negotiate prices for certain drugs covered under Medicare Parts B and D directly with pharmaceutical companies (Negotiation Program).1 Under President Biden, the Centers for Medicare & Medicaid Services (CMS) negotiated 2026 pricing for a list of 10 drugs. CMS projects roughly $6 billion in Medicare Part D savings ($1.5B for patients) attributed to the 2026 list. Unless Congress changes the IRA or the Trump Administration unwinds the CY 2026 pricing, those prices will go into effect on January 1, 2026. In early 2025, CMS identified a list of 15 additional products to negotiate for 2027—those price negotiations were originally set to occur in 2025.
The IRA restricts which drugs Medicare can select for price negotiations. A small-molecule drug product must be at least seven years past its FDA approval date to qualify for price negotiations and nine years past its FDA approval date before the negotiated price can take effect. A biologic drug must be at least 11 years past its FDA approval date to qualify for price negotiations, and 13 years past its FDA approval date before the negotiated price can take effect. Some in the industry have termed the four-year difference between when small-molecule drugs and biologics qualify for price negotiations as a “pill penalty,” a reference to the fact that small-molecule drugs are often marketed as orally available pills (i.e., tablets or capsules) whereas biologics are generally only available via parenteral routes of administration (i.e., via injection).
The Executive Order addresses these points, explaining that the Negotiation Program “has the commendable goal of reducing the drug prices Medicare and its beneficiaries pay,” but claims that “its administratively complex and expensive regime has thus far produced much lower savings than projected.” The Executive Order also discusses “the ‘pill penalty’” and says that it “threatens to distort innovation by pushing investment towards expensive biological products, which are often indicated to treat rarer diseases, and away from small molecule prescription drugs, which are generally cheaper and treat larger patient populations.”
The Executive Order includes directives aimed at improving the IRA, including that the Secretary of Health and Human Services (HHS) (the Secretary) “shall work with the Congress to modify the Negotiation Program to align the treatment of small molecule prescription drugs with that of biological products, ending the distortion that undermines relative investment in small molecule prescription drugs, coupled with other reforms to prevent any increase in overall costs to Medicare and its beneficiaries.” The Executive Order also directs the Secretary to “propose and seek comment on guidance for the Medicare Drug Price Negotiation Program for initial price applicability year 2028 and manufacturer effectuation of maximum fair price under such program in 2026, 2027 and 2028” by June 14, 2025. And the order directs Director of the Office of Management and Budget, the Secretary, and various policy advisors to “provide recommendations to the President on how best to stabilize and reduce Medicare Part D premiums” within 180 days of the order.
Finally, in a related initiative, the Administration directs the Secretary to use the Center for Medicare and Medicaid Innovation to develop “a payment model to improve the ability of the Medicare program to obtain better value for high-cost prescription drugs and biological products covered by Medicare, including those not subject to the Medicare Drug Price Negotiation Program” within one year of the Executive Order.
While the Executive Order didn’t formally eliminate prior price negotiation efforts, it will likely delay the government’s ability to negotiate lower prices for several of the most expensive prescribed drugs on the market as guidance is developed. 340B Covered Entities should track these developments as the required guidance could include more direction on implementation of the maximum fair price (MFP) and how CMS intends to address manufacturer and 340B Covered Entity concerns regarding the interplay between the MFP and 340B Program purchases.
2. Survey to Identify Hospital Drug Acquisition Costs and Develop Updated Drug Pricing Policies
Following years of litigation regarding a controversial 2018 CMS payment reduction for 340B drugs, a victory for 340B Covered Entities at the Supreme Court in June 2022, and lump sum payments as a remedy to 340B Covered Entities, the 340B Program rollercoaster continues for these safety net entities. The Executive Order requires the Secretary to publish a plan to conduct a hospital acquisition cost survey for covered outpatient drugs pursuant to Section 1833(t)(14)(D)(I) of the Social Security Act (the Act). Under Section 1833(t)(14), HHS may vary drug payment by hospital group if an acquisition cost survey is available. HHS lost its battle with 340B Covered Entities when it failed to demonstrate that it conducted a survey as required by the Act. It appears that the Executive Order is intending to address that deficiency so CMS can attempt to change drug payment rates.
While this is a developing issue, it appears the Trump Administration is trying to address this prior loss head on and revisit drug payment rates. Hospitals, particularly 340B Covered Entities, need to be prepared to address any survey method deficiencies (e.g., 340B pricing is confidential), and they need to be ready to respond to very challenging written survey requests. This is reminiscent of CMS’s survey attempt in April 2020 that was released on the heels of the COVID-19 pandemic. We are also monitoring the rumored shift of 340B Program oversight from the Health Resources and Services Administration (HRSA) to CMS, as that could play a significant role in this survey process and other 340B Program oversight functions.
3. Insulin and Epinephrine Discounts via Federally Qualified Health Centers (FQHCs)
The Executive Order instructs HHS to reinstitute a mandate that applies to insulin and injectable epinephrine acquired by FQHCs. The mandate would require FQHCs to provide these products to low-income patients (to be defined) at or below the 340B Program price, plus a minimal administration fee.
Many FQHCs already provide access to these products at heavily discounted pricing per their sliding fee scale policies developed pursuant to HRSA grant guidance. For many FQHCs, this policy may present operational challenges for products dispensed via contract pharmacies. Likewise, the Executive Order does not address situations where FQHCs are unable to obtain the dispensed products at 340B Program pricing, including due to shortages or manufacturers refusing to sell products at discounted prices. This policy may reignite tension between manufacturers and 340B Covered Entities, as drugmakers continue to restrict 340B pricing access on certain products. Because these operational and acquisition challenges could lead to significant losses, FQHCs need to remain involved in advocacy as any resulting policies are developed by HHS.
4. Site Neutral Payment Policy for Drug Administration Fees
The Executive Order directs the Secretary to evaluate and propose regulations to remove payment policies that incentivize providers to direct drug administration volume away from physician practices to hospital outpatient departments. While the Executive Order didn’t elaborate further, it’s likely that this directive is intended to target existing payment differences for drug administration codes when billed by provider-based hospital outpatient departments versus freestanding physician offices.
Hospitals, including 340B Covered Entities, should closely monitor this development. There is a history of bipartisan support for various site neutral policy proposals, and the directive may be a sign of more policies to come that may impact payment to and/or oversight of provider-based departments. Decreasing payment for drug administration services while also adjusting payments for the underlying drugs based on acquisition cost survey data discussed above could result in a substantial hospital payment reduction that could severely impact budgets. Such policy decisions would frustrate the intent of the 340B Drug Pricing Program.
5. Initiatives Impacting Manufacturers and PBMs
The Executive Order also includes initiatives that could impact drug manufacturers and PBMs and may require significant changes to their operations. These initiatives include:
Streamlining and improving the importation of prescription drugs from Canada under section 804 of the Federal Food, Drug, and Cosmetic Act;
Holding public listening sessions and issuing a report with recommendations to reduce anti-competitive behavior by pharmaceutical manufacturers;
Ensuring accuracy of Medicaid drug rebates consistent with Section 1927 of the Act;
Coordinating with FDA to develop recommended administrative and legislative changes to accelerate approval of generics, biosimilars and over-the-counter medications;
Providing recommendations on how to promote more competition, efficiency, transparency and value in the supply chain. The section title suggests that PBMs will remain in the spotlight; and
Proposing regulations consistent with the Employee Retirement Income Security Act of 1974 to improve PBM direct and indirect compensation transparency.
Key Takeaways:
Many of these directives and policy proposals will require legislation from Congress, as the Executive Order acknowledges. For example, the Executive Order has endorsed changes to the IRA—most notably it calls on Congress to pass legislation that would end the so-called “pill penalty,” which could restrict or delay Medicare’s ability to negotiate prices for small-molecule drugs if the time thresholds for small-molecule drugs are extended to match the timelines for negotiation of biologics.
Other directives and policy proposals in the Executive Order, however, may be enacted without the need for legislation from Congress. As a practical matter, implementing several of these proposals may be challenging in light of the reductions in force and structural changes implemented at HHS. As one example, and as noted above, the Executive Order aims to accelerate competition for high-cost prescription drugs and calls for “a report providing administrative and legislative recommendations to” accelerate approvals of generics, biosimilars and over-the-counter medications. However, accelerating approvals of generic and biosimilar products could be more difficult due to the elimination of the Division of Policy Development in the FDA’s Office of Generic Drug Policy.
This Executive Order marks the second major action taken by the current administration this month involving pharmaceuticals. We previously reported on new Section 232 Trade Investigations into the imports of pharmaceutical and pharmaceutical ingredients, and derivative products of those items, which could lead to trade actions related to imported pharmaceuticals.
The landscape in the pharmaceutical supply chain is changing at a breakneck pace. Actions taken pursuant to the Executive Order could result in significant changes to a number of policy issues related to the pharmaceutical and reimbursement spaces in the coming months and years. And it’s possible that many of these changes could lead to litigation.
[1] Under the IRA, the negotiated prices for the selected drugs that are covered under Medicare Part D will take effect in 2026, while negotiated prices for drugs covered under Medicare Part B are set to take effect in 2028.
Google Announces Next Steps for Privacy Sandbox and Tracking Protections in Chrome Browser
On April 22, 2025, Google announced that it will continue to offer third-party cookies in its Chrome browser and will not roll out a new standalone prompt for third-party cookie preferences. Chrome users must continue to make third-party cookie choices through Chrome’s existing Privacy and Security Settings. This development follows Google’s July 2024 announcement that it was scrapping its previously-declared plan to phase out the use of third-party cookies in its Chrome browser.
According to Google, this latest development is a result of the company’s engagement with stakeholders, including publishers, developers, regulators and the ad industry, which Google notes demonstrated that there remains “divergent perspectives on making changes that could impact the availability of third-party cookies.” Google also cited other factors which it had taken into account, such as the accelerated adoption of privacy-enhancing technologies and the emergence of new opportunities to safeguard and secure users’ browsing experiences with artificial intelligence (“AI”).
Google’s announcement indicates that the company intends to continue to enhance existing tracking protections and invest in technologies, such as built-in password protections and AI-powered security protections. Google also noted that in light of its update, it understands that the Privacy Sandbox APIs may have a different role to play in supporting the ad ecosystem and indicated it would share an updated roadmap for these technologies in the coming months.
Red Tape Rollback: DOJ’s Anticompetitive Regulations Task Force
As we predicted before the inauguration, Trump 2.0 antitrust enforcers have shown continued support for the pro-worker, anti-tech antitrust agenda that has permeated recent antitrust enforcement through the last two administration changes. This time around, President Trump appointed competition agency leaders in Chair Ferguson at the Federal Trade Commission (FTC) and AAG Slater at the Department of Justice Antitrust Division (DOJ) who identify with a brand of conservative populism coalescing around many of the same policies and priorities as Biden-appointed competition leaders like FTC Chair Lina Khan. For example, since the inauguration, antitrust agencies under their leadership have forged on with antitrust cases against Big Tech, backed the Biden-era revisions to the merger and labor guidelines, and doubled down on efforts to use antitrust laws to protect American workers.
The Anticompetitive Regulations Task Force
The DOJ recently announced an Anticompetitive Regulations Task Force “to advocate for the elimination of anticompetitive state and federal laws and regulations that undermine free market competition and harm consumers, workers, and businesses.”
The move was instigated by President Trump’s Executive Orders 14192 and 14219, which promote deregulation and direct agencies to identify regulations that “impede private enterprise and entrepreneurship.” To that end, the Task Force will partner with federal agencies to help identify regulations that inhibit competition in the industries they monitor. Significantly, EO 14192 requires that for an agency to promulgate new regulation, it must identify at least ten existing regulations to be repealed. Similar efforts have been announced across other agencies.
In addition to advising agencies, the Task Force “Invites Public Input Targeting Red Tape that Hinders Free Market Competition” and is soliciting public comments at www.Regulations.gov through May 26 on regulations that interfere with businesses’ ability to compete. This is a powerful prospect for those interested in influencing competition policy, since the administration appears to be looking to do away with as much regulation as possible and has shown it can move quickly.
The Task Force also seeks to influence policy by filing amicus briefs in private litigation and weighing in on proposed state legislation. In a “what’s old is new again” way, much of this work has been done for decades by the DOJ’s Policy and Appellate Sections, and examples of this type of competition advocacy spanning more than a decade can be found in its Comments to Federal Agencies, Comments to States and Other Organizations, and Statements of Interest.
Industries of Interest
The Task Force intends to focus on markets that have the greatest impact on American households, including:
Housing
Transportation
Food and Agriculture
Healthcare
Energy
The cited industries of interest are unsurprising, since not only are they currently tightly regulated, but they also represent some of the largest areas of government spending and have been a perennial focus of antitrust investigations, litigation, enforcement, and competition advocacy. Indeed, these industries are held out by some as examples of industries dominated by large players.
The Task Force announcement focuses on the ways red tape regulations hurt small businesses by imposing barriers to entry and inequitably increasing compliance costs. A purported goal is to cut back regulations in order to make it easier for smaller, disruptive companies (“Little Tech!”) to enter these industries and successfully compete. However, the effects of anticompetitive regulations and any regulatory rollbacks will be experienced equally by large and established companies, so the call for identification of areas in need of rollback appears to be open to all.
Potential Impact
While businesses are attempting to navigate the administration’s other swift changes, this Task Force presents an opportunity for some long overdue positive changes, particularly in areas plagued by anticompetitive red tape. For example, in the healthcare industry, the DOJ and FTC have expressed competition concerns relating to Certificate of Need laws in numerous states.
The energy industry could present an interesting policy conundrum for Trump 2.0 antitrust enforcers as the smaller, disruptive market participants the Task Force encourages to speak up are likely non-incumbent alternative and environmentally conscious energy providers. While these issues are likely to be swept into the Task Force’s review, it remains to be seen whether the Trump administration will have an appetite to advocate for these providers’ competitive footing, or instead focus on seeking rollback of ESG-focused regulations.
Similarly, the Task Force’s attention to small businesses means another likely target is occupational licensing. Under the previous Trump administration, the FTC’s Economic Liberty Task Force released a report on Options to Enhance Occupational License Portability, but rolling back licensing requirements altogether could push the administration’s policy goals much further. Here too, regulation repeal would likely face a fair amount of pushback, even from within the industries.
Conclusion
While the fruits of the Task Force’s efforts will likely take a long time to materialize, companies—particularly those in the Housing, Transportation, Food and Agriculture, Healthcare and Energy industries—have a meaningful opportunity to call out barriers to competition that they face and potentially impact competition agencies’ focus.
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EU Loses WTO Challenge Against China’s Anti-Suit Injunctions; Files Appeal
As predicted by ip fray on April 10, 2025, the European Union (EU) has confirmed on April 22, 2025 it lost the World Trade Organization (WTO) proceedings against China over anti-suit injunctions (ASIs) for standard essential patents (SEPs). The EU is appealing. In August 2020, China’s Supreme People’s Court decided that Chinese courts can prohibit patent holders from going to a non-Chinese court to enforce their patents by putting in place an “anti-suit injunction”. The Supreme People’s Court also decided that violation of the order can be sanctioned with a 1 million RMB daily fine. Since then, Chinese courts have adopted several additional anti-suit injunctions against foreign patent holders leading to the current dispute.
Per the EU,
[T]he WTO panel upheld the EU’s case by acknowledging that China has developed a policy of limiting intellectual property rights, starting with the guidelines of the Supreme People’s Court, supported by the political level and implemented by the judiciary through several court judgments. It also found that China must be more transparent by transmitting to the EU and other WTO members information on intellectual property matters, including court judgements.
However, the panel did not follow the EU’s interpretation of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement as requiring China to refrain from adopting or maintaining measures that undermine other WTO members’ implementation of the agreement in their jurisdictions. According to the panel, the TRIPS Agreement does not contain an obligation for WTO members to abstain from adopting measures that prevent other WTO members from implementing it in their own territories.
China’s Ministry of Commerce responded on April 23, 2025:
China has always attached great importance to intellectual property protection and its achievements are obvious to all. China is pleased to see that the WTO expert group supports China’s claims. China has received the EU’s appeal request and will handle it in accordance with the relevant rules of the MPIA to safeguard its legitimate rights and interests.
An additional WTO complaint filed by the EU against China continues to proceed regarding setting global royalty rates for SEPs in DS632.
The EU appeal can be found here (English) and China’s response as reported by Xinhua here (Chinese).
Wyoming Joins the List of States Banning Some Noncompete Agreements
On March 19, 2025, Wyoming became one of the latest states to enact legislation banning noncompete agreements.
The new law, which goes into effect July 1, 2025, voids “[a]ny covenant not to compete that restricts the right of any person to receive compensation for performance of skilled or unskilled labor.” The law applies only to contracts entered into on or after July 1, 2025, and specifically states that nothing in the law alters, amends or impairs “any contract or agreement entered into before July 1, 2025.”
The law, as drafted, broadly applies to any agreement containing a noncompete clause, such as an employment agreement, independent contractor agreement, or some other type of agreement. The law does not impact or address non-solicitation agreements.
Though the new law appears on its face to be far-reaching, it contains notable exceptions that effectively narrow the scope of noncompetes impacted by the law, discussed below.
Trade Secret Exception
The Wyoming noncompete ban does not include covenants not to compete “to the extent the covenant provides for the protection of trade secrets as defined by W.S. 6-3-501(a)(xi).” Under W.S. 6-3-501(a)(xi), “trade secret” is broadly defined as:
the whole or a portion or phase of a formula, pattern, device, combination of devices or compilation of information which is for use, or is used in the operation of a business and which provides the business an advantage or an opportunity to obtain an advantage over those who do not know or use it. “Trade secret” includes any scientific, technical or commercial information including any design, process, procedure, list of suppliers, list of customers, business code or improvement thereof. Irrespective of novelty, invention, patentability, the state of the prior art and the level of skill in the business, art or field to which the subject matter pertains, when the owner of a trade secret takes measures to prevent it from becoming available to persons other than those selected by the owner to have access to it for limited purposes, the trade secret is considered to be:
(A) Secret;
(B) Of value;
(C) For use or in use by the business; and
(D) Providing an advantage or an opportunity to obtain an advantage to the business over those who do not know or use it.
The breadth of Wyoming’s statutory definition of “trade secret” arguably leaves employers with a fair amount of leeway to structure their restrictive covenants so that they fall under this exception.
Executive and Management Personnel Exception
The law also excludes noncompete agreements entered into with executive and management personnel and officers and employees who constitute professional staff to executive and management personnel. The law does not define the terms “executive and management personnel” or “officers and employees who constitute professional staff to executive and management personnel,” potentially providing employers relatively wide latitude in determining which employees may fit within this exception.
Physicians
The law also voids covenants not to compete in employment, partnership or corporate agreements between physicians that restrict the rights of a physician to practice medicine as that term is defined under Wyoming’s Medical Practice Act. All other provisions of a physician’s agreement that are “enforceable at law shall remain enforceable.”
Additionally, physicians will be permitted to disclose their “continuing practice of medicine and new professional contact information to any patient with a rare disorder as defined in accordance with the national organization for rare disorders, or a successor organization, to whom the physician was providing consultation or treatment before termination of the employment, partnership or corporate affiliation.” Physicians, and their new employers, shall not be liable for any damages resulting from the disclosure or from the physician’s treatment of the patient following the termination of the agreement or the physician’s employment, partnership or corporate affiliation.
Expense Repayment Provisions
Contractual provisions for recovering the “expense of relocating, educating and training an employee” are also exempt from the new law pursuant to the following statutory repayment provisions based on how long the employee has worked for the employer:
(A) Less than 2 years: Recovery up to 100% of expenses
(B) At least 2 years but less than 3 years: up to 66% of expenses
(C) At least 3 years but less than 4 years: 33% of expenses
(D) 4 or more years: 0% of expenses
Contract for the Purchase and Sale of a Business or Its Assets
Finally, the law also excludes covenants not to compete that are contained in a contract for the purchase and sale of a business or the assets of a business.
Key Takeaways
Employers wishing to enter into noncompete agreements on or after July 1, 2025 may only do so if the noncompete falls within one or more of the law’s specific carveouts. Notably, the law does not provide for any statutory damages or penalties, such as an attorneys’ fee-shifting or “loser pays” penalty, should a party choose to challenge the validity of a noncompete agreement. The law’s lack of a damages or penalties provision could potentially diminish the law’s impact as employers may perceive little risk in asserting a noncompete provision which falls under one or more of the law’s more expansive exceptions, such as the trade secret exception or executive and management personnel exception.
As Wyoming joins the growing list of jurisdictions considering and adopting legislation governing noncompetes, we will continue to report on key legislative updates and trends
State Antitrust Enforcement Roundup: New Laws; New Potential Legislation; and New (and Broader) Areas of Focus
The number of U.S. states implementing or considering new antitrust laws (or supplementing existing laws) targeting proposed transactions continues to grow. As detailed in our healthcare merger matrix, many states have focused their attention on the healthcare industry, and that continues to be the case, for example, in New York, where a broad range of proposed transactions involving health care entities could be subject to filing requirements and suspensory rules before they can close.
Moreover, and as detailed below, recently adopted laws and legislation under consideration in certain states are not limited to transactions involving healthcare providers or payors, nor are such developments limited to “blue” (politically more liberal) states, with Arkansas, Texas, Utah, and West Virginia, among others, undergoing or considering substantial expansions of their respective antitrust laws.
Arkansas Adopts Law Banning Pharmacy Benefit Managers from Owning Pharmacies
On April 16, 2025, Governor Sarah Huckabee Sanders signed HB 1150 into law, which will prohibit pharmacy benefit managers (“PBMs”) from owning pharmacies. This Arkansas law is the first of its kind and provides that a pharmacy benefits manager shall not acquire a direct or indirect interest in, or otherwise hold, directly or indirectly, a permit for the retail sale of drugs or medicines as of January 1, 2026.
California Considers Expansive New Antitrust Laws
In 2022, the California Law Review Commission (CLRC) was asked by the California Legislature to consider and recommend revisions to the state’s competition laws, i.e., the Cartwright Act. As a result of its review, the CLRC has recommended substantial revisions to the state’s antitrust regime.
The CLRC’s recommended changes cover the antitrust enforcement waterfront, from single firm conduct (monopolization and attempted monopolization) to concerted action. With respect to mergers, the CLRC found that California should adopt its own, independent merger control regime (today the state may only challenge deals under the federal Clayton Act). Most notably, the CLRC proposed that California become more aggressive when it comes to challenging proposed transactions by adopting a lesser standard to challenge deals than the federal standard, which requires the FTC or DOJ to provide that it is more likely than not that a deal would substantially lessen competition.
Washington State Enacts First-in-the-Nation General Premerger Notification Law; Colorado, D.C., Hawaii, Nevada, Utah, and West Virginia Considering Similar Legislation
The state of Washington became the first state to enact a state-level general premerger requirement. While many states have industry-specific notification laws (e.g., for health care mergers), this is the first general premerger notification requirement for a state. The law is modeled on the Uniform Antitrust Premerger Notification Act. Similar legislation is under consideration in California, Colorado, the District of Columbia, Hawaii, Nevada, Utah and West Virginia.
Starting July 27, 2025, any person that files a federal Hart-Scott-Rodino (“HSR”) filing must also submit contemporaneously a copy of the HSR form to the state if the person meets one of three criteria:
the person’s “principle place of business” is in Washington; or
the person (or a person it controls directly or indirectly) has annual net sales in Washington for the goods or services involved in the proposed transaction that are at least 20% of the Federal HSR size of transaction filing threshold (at present, 20% is $25,280,000); or
the person is a healthcare provider or provider organization in Washington (filing already required under Washington’s existing healthcare transaction law).
All required Washington filers must submit a copy of their federal HSR form to the state. Filers whose principle place of business is in Washington must also file the additional documentary material filed with an HSR form. Notably, the state may, upon request, require any filer to submit the additional documentary material, even if their principle place of business is not in Washington. There is no filing fee for the state filing and it does not trigger a suspensory waiting period. However, failure to file may result in a civil penalty of up to $10,000 per day of noncompliance.
* * * * *
We can now definitively say that the growing state-level interest in becoming active participants in the review process for transactions that impact their state is part of a long-term secular trend. Regardless of political bent, many states are no longer content to sit passively by while the FTC or DOJ make enforcement decisions that can have dramatic impacts at the state level. In the months and years that follow, we expect that more states will enact antitrust or antitrust adjacent laws that are independent of and potentially even more stringent than, the federal antitrust regime. These state regimes, once more of an afterthought, will require the full attention of parties considering transactions that may be captured by these new laws.
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A Roadmap for Export Controls? Project 2025 and the Future of U.S. Exports – Part I
The second Trump administration has come flying out of the starting blocks on international trade policy actions—imposing and rescinding, shaping and reshaping tariffs, sanctions, and export controls. The executive orders and directives have come so thick and fast that it is not always simple for businesses to chart a consistent policy direction and develop their plans to account for what might be coming next.
However, there is in fact a pretty clear map that could indicate the U.S. policy direction with respect to export controls.
The U.S. Department of Commerce, Bureau of Industry and Security (BIS) may well follow the map that was drafted by the same people who are now among the BIS leadership. The cartographers, as it were, are James Rockas and Robert Burkett. Rockas and Burkett now serve as the Deputy Under Secretary and Chief of Staff, respectively, at BIS. Both are listed as authors of the chapter on the Department of Commerce in the Project 2025 Mandate for Leadership publication by the Heritage Foundation.[1] Regardless of one’s views on Project 2025, the publication is a useful indicator of the future of U.S. export controls, among other policies.
In this article, we examine what the proposed “modernization” of the Export Administration Regulations (EAR) outlined in Project 2025 looks like, and analyze how the Project 2025 proposals could be implemented in future U.S. export regulations.
The Checklist
The section of Project 2025 dedicated to BIS presents a list[2] of key priorities for “EAR modernization”, as follows:
Featured Today
Eliminating the “specially designed” licensing loophole;
Redesignating China and Russia to more highly prohibitive export licensing groups (country groups D or E);
Eliminating license exceptions;
Broadening foreign direct product rules;
Reducing the de minimis threshold from 25 percent to 10 percent—or 0 percent for critical technologies;
Tightening the deemed export rules to prevent technology transfer to foreign nationals from countries of concern;
Tightening the definition of “fundamental research” to address exploitation of the open U.S. university system by authoritarian governments through funding, students and researchers, and recruitment;
Eliminating license exceptions for sharing technology with controlled entities/countries through standards-setting “activities” and bodies; and
Improving regulations regarding published information for technology transfers.
On first reading, some of these proposals may not seem to fit neatly within the familiar EAR framework. That might make it hard to picture how they will be implemented in regulations, much less to plan for them.
But that’s just the sort of picturing we propose to take on!
We have worked our way through the list above. We have asked ourselves how those broad, potentially seismic changes might actually be put into practice. Where is there real room for rewriting the regulations? Where is there precedent in export regulatory history? (Where what’s past be prologue, to borrow a phrase)?
Here we present our initial thoughts on what may be coming. We note that none of these points constitutes legal advice. But they may be useful for considering where your organization may wish to consider the possibility of future export control regulations.[3] And they may come fast, so get ready. As the poet said, defer no time. Delays have dangerous ends.
We present our findings in three parts (in three days), dividing the list to conquer it and to do so without overburdening our readers.
1. “Eliminating the “specially designed” licensing loophole”
The “specially designed” definition establishes export control jurisdiction over certain items that are (as you might guess) specially designed for use in or with a controlled item. The definition has two parts—a catch and a release. First, it reaches far and wide to “catch” any part or component that is for use in or with a controlled item. Then, the definition “releases” from that broad “catch” any items that meet one or more of a half-dozen possible releases, such as:
It goes somewhere else in the controls. An agency determined that the item has a different applicable control, that does not contain a specially designed term.
It is just a little fella. The item is a screw, nut, bolt, clip, pin, washer, grommet bushing, spring, etc.
It works the same as a non-controlled item. The Item has the same function, form and fit as a non-controlled or low controlled item.
It was made for something else. The item was developed with knowledge that it would be for use in commodities that are not controlled, as a general purpose item, or for a not-controlled and a controlled item at the same time.
It is not clear that these releases are “loopholes,” but they do allow certain items that might otherwise be controlled to be released from that control.
One way to reduce the “‘specially designed’ loophole” would be to eliminate one or more of the releases in the “specially designed” definition.
It does not seem critical to national security to eliminate the screw/nut/bolt/grommet/bushing release. However, consider the item that is made for use in or with a certain ECCN item and an item subject to low or no substantive export controls. Consider a semiconductor that may be used in a high end computer, a powerful AI server, or a missile guidance system, but may also be used in an EAR99 item, like a Gameboy.[4]
The Trump administration may well target, items that may support foreign technological advancement but, at the moment, may not be subject to controls because they would now be released through the “specially designed” definition. Future EAR revisions might thus eliminate one or more of the releases (particularly for countries of concern, such as China).
2. “Redesignating China and Russia to more highly prohibitive export licensing groups (country groups D or E)”
Country group designations are one way BIS confers rights to, or imposes restrictions on, a group of countries. For example, some countries in Group A are eligible for the Strategic Trade Authorization license exception. By contrast, countries listed in Group D:5 are subject to U.S. arms Embargoes.
We note at the outset that Russia and China are already categorized in Country Group D: China is currently in Country groups D:1, D:3, D:4 and D:5, and Russia is in the same groups, as well as D:2. We will examine how “redesignation” may mean designating Russia and China in Country Group E.
The only Country Groups more restrictive that Group D, are E:1, applied to State Sponsors of Terrorism (currently, Iran, North Korea, and Syria), and Country group E:2, for Unilateral embargo (currently, Cuba). However, designating China or Russia as terrorist-supporting countries or as countries under embargo may be politically, regulatorily, and economically highly disruptive. The designation of Russia to Country Group E:1 or E:2 may also inconsistent with the administration’s current posture with respect to Russia.
However, one potential approach may be to create a new Country Group (e.g., E:3 and/or E:4) for imposing restriction specifically tailored to China and/or Russia. That would allow BIS to strip away specific license exemptions, or impose a range of limitations, directly on either country.
3. “Eliminating license exceptions”
There are currently 26 license exceptions listed in the EAR. Project 2025 does not specify which ones would be eliminated. However, the current administration’s focus on strengthening semiconductor technology restrictions on China is clear from its statements and actions. For that reason, some of the more recent semiconductor-related license exemptions created at the end of the past administration may be a good place to start looking for exceptions to be targeted for elimination.
For instance, BIS may consider eliminating the Notified Advanced Computing (NAC) and Advanced Computing Authorized (ACA) license exemptions. Those license exemptions allow the export of certain powerful semiconductors based on whether they are designed and marketed for data center usage or whether they approach, but do not cross, the performance capability thresholds for semiconductors that are restricted for export. Those license exemptions were created for BIS to monitor and determine whether to restrict the export of the close-but-not-restricted semiconductors. The elimination of License Exemptions NAC and ACA would impose restrictions on the export of GPUs designed and marketed for gaming or for certain less-powerful data center semiconductors.
Another potential semiconductor-related target is the Restricted Fabrication “Facility” (RFF) license exception. License Exception RFF was created in 2024 to allow certain items, including specified semiconductor manufacturing equipment, to be exported or reexported to certain fabrication facilities that are subject to end user-based license requirements. Ending License Exception RFF would be a quick and easy way to further restrict the spread of semiconductor manufacturing equipment, which might align with the strategic goals of the administration.
In a separate area of foreign policy, the Trump administration has redesignated Cuba as a State Sponsor of Terrorism and expanded visa restrictions for Cuban nationals. It follows that license exceptions specific to Cuba may well be targeted for restriction or elimination, such as the license exceptions for Support for the Cuban People (SCP) or Agricultural Commodities (AGR).
Conclusions and Early Indications
The second Trump administration has issued, rescinded, revised, and reissued a substantial number of tariffs, sanctions, and export control measures. Although it is easy to be overwhelmed by the volume of actions, some of the policy direction of the new administration is clear. And as outlined here, the Commerce Department chapter of the Project 2025 Mandate for Leadership provides strong indicators of the administration’s policy direction on export controls.
At the same time, developments outside the four corners of Project 2025 suggest that certain reforms may already be in motion. On April 10, 2025, Landon Heid—President Trump’s nominee for Assistant Secretary of Commerce for Export Administration—testified before the Senate Banking Committee and indicated that BIS may act “relatively quickly” to apply Entity List restrictions to subsidiaries of listed entities, drawing a parallel to OFAC’s 50% rule. If implemented, this shift would materially expand the scope of compliance obligations for exporters, reexporters, and technology providers by effectively capturing foreign subsidiaries and affiliates that have so far fallen outside the scope of licensing requirements.
Heid’s remarks also flagged broader enforcement priorities—particularly around China’s acquisition of artificial intelligence capabilities. He pointed to risks associated with transshipment through jurisdictions such as Hong Kong and suggested BIS may pursue tighter controls to curb diversion and illicit procurement of advanced technologies. Those developments, while not explicitly part of Project 2025, reflect an accelerating trajectory toward more expansive and aggressive export control enforcement.
Together, the Project 2025 blueprint and the emerging policy posture from BIS leadership offer a coherent preview of what the next phase of U.S. export regulation may look like. Companies would do well to monitor those signals and begin scenario planning for a regulatory environment in which the scope of control is broader, the tools are sharper, and the compliance expectations are higher.
FOOTNOTES
[1] Available at 2025_MandateForLeadership_CHAPTER-21.pdf
[2] Id. at p.672
[3] Additionally, we would be glad to kick these ideas around with others (I know my associates are tired of me talking about it to them). So if you have any comments, questions, or ideas to posit, please feel free to contact the authors directly.
[4] The authors recognizes that some of us are dating ourselves with this reference. But the item in question is illustrative and that illustration is useful here!
Employment Law This Week Episode – Non-Competes Eased, Anti-DEI Rule Blocked, Contractor Rule in Limbo [Video, Podcast]
This week, we’re covering the relaxation of state-level non-compete rules, the recent block of Executive Order 14173’s diversity, equity, and inclusion (DEI)-related certification requirement, and a federal appeals court’s decision to pause a challenge to the Biden-era independent contractor rule.
Non-Competes Eased in Kansas and Virginia
Kansas has enacted a law permitting non-competes while setting requirements for non-solicit provisions. Additionally, effective July 1, 2025, Virginia will prohibit non-compete agreements for non-exempt employees.
Federal Contractor DEI Rule Blocked
In a lawsuit brought by Chicago Women in Trades, a federal judge paused a rule from Executive Order 14173 requiring federal contractors to certify that they don’t operate DEI programs that violate anti-discrimination laws, citing unclear definitions of “illegal” DEI programs.
Independent Contractor Rule in Limbo
The U.S. Court of Appeals for the Fifth Circuit paused a challenge to the 2024 independent contractor rule, allowing the U.S. Department of Labor time to consider revising or replacing it. For now, the Biden-era rule remains in effect.
The Lobby Shop: Reconciliation Reckoning [Podcast]
The Lobby Shop team turns their focus on the ongoing budget reconciliation process in Congress that will shape the Trump administration’s economic agenda. Hosts Josh Zive, Paul Nathanson and Liam Donovan provide a quick update on the latest tariff developments before diving into the reconciliation process and the shifting legislative dynamics between the House and the Senate. Then, Liam does a deep dive on how economic pressures are reshaping political strategy, and what it all means for government funding timelines and the looming debt ceiling. Tune in for a Liam-style breakdown of the often confusing reconciliation process in the next couple of weeks.
What Every Multinational Company Should Know About … Tips and Tricks for Sell-Side Contracts
Assessing Tariff Impacts in Commercial Contracts
With the size and scope of President Trump’s tariffs continuing to shift, this is a critical time for businesses to assess their contracts and determine how increased tariff costs might adversely affect profitability, and whether there are any strategies to mitigate the losses.
Contract Review for Tariff Provisions
Tariffs typically affect profitability in two primary ways:
Increased costs of material or component inputs due to the tariffs, and
Tariffs applied to the final sale price of imported or exported goods.
As indicated below, force majeure and commercial impracticability provisions are blunt instruments, meaning the allocation of tariff-related costs is best addressed in the pricing provisions of commercial contracts. When drafting these provisions, consider the following:
Price Adjustments: Inclusion of a mechanism allowing for equitable price increases in response to rising costs associated with taxes, duties, tariffs, or other expenses resulting from changes in law, regulations, or other agreed-upon reasons can be beneficial to the seller. These types of pricing provisions can mitigate financial strain from tariff hikes.
Tariff Allocation: Tariffs are always paid directly to U.S. Customs by the importer of record, which must be a single party. But Customs does not care if parties reallocate tariff responsibility behind the scenes. Pricing provisions thus can specify how tariff costs are allocated between parties for foreign goods imported into the United States and for goods exported to foreign countries. This allocation can be drafted via express provisions on the topic or through careful use of Incoterms to set forth delivery responsibility. Clarity regarding (a) which party is responsible for paying any tariffs to the applicable government agency; (b) whether the seller, the buyer, or both share responsibility for tariff payments; and (c) what the reimbursement mechanism will be, if any, is essential for cost planning and risk mitigation.
In cases where pricing provisions do not provide adequate protection against tariff-related costs, other contractual clauses should be reviewed. For example:
Termination Rights: Termination provisions may offer an exit strategy if continued performance becomes economically unsustainable. Particular attention should be given to whether termination for convenience is permitted and, if so, what notice requirements apply.
Purchase Order Acceptance/Rejection: Contracts may provide flexibility regarding the acceptance or rejection of purchase orders. In the absence of a fixed quantity commitment or a requirements/output agreement, a seller may be able to reject orders and thereby decline to supply products.
Common Misconceptions Regarding Tariff Relief
Force Majeure/Commercial Impracticability: A frequent misconception is that a force majeure clause or the doctrine of commercial impracticability may apply to excuse performance due to increased tariff costs. While these doctrines are sometimes used strategically to initiate discussions around contract renegotiation, courts often view cost increases as foreseeable business risks that cannot support invoking force majeure or commercial impracticability defenses (unless the cost increase, such as a heightened tariff, is expressly identified as a force majeure event that excuses performance).
Tax Allocation Provision: Another common misconception is that a tax provision, providing the buyer pays all taxes, will permit a U.S. seller to pass along the tariffs on its inputs to a U.S. buyer. Typically, tax provisions are drafted to allocate responsibility for taxes levied on the transaction between the buyer and seller and do not contemplate taxes/tariffs levied on the upstream inputs.
Recommended Next Steps
This is an area of law where sophisticated counsel can help identify your working options under current contracts and maximize your company’s ability to take proactive steps to manage future tariff-related risks. Managing the effects of tariffs, or other unexpected governmental actions, requires a tailored approach based on each company’s contractual leverage and commercial relationships. A thorough contract review, coupled with proactive communication with business partners, can provide a solid foundation for addressing tariff challenges.