ALIGN TECHNOLOGY INC (ALGN) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that ALIGN TECHNOLOGY INC surfaced in its latest filing.

• U.S. Department of Commerce completed investigation under Section 232 of the Trade Expansion Act of 1962 on imports of PPE, medical consumables, and medical equipment including devices.
• On February 20, 2026, the U.S. Supreme Court ruled that certain tariffs imposed under IEEPA were unlawful.February 20, 2026
• United States imposed a temporary import surcharge on most imports under Section 122 of the Trade Act of 1974, effective February 24, 2026, which was subsequently held unlawful by the U.S. Court of International Trade, stayed pending appeal, and expired on July 24, 2026.February 24, 2026
• On July 24, 2026, the Office of the U.S. Trade Representative imposed additional duties under Section 301 of the Trade Act of 1974 on imports from the top 60 U.S. trade partners, not subject to a statutory rate cap or fixed expiration date.July 24, 2026
• Our iTero operations are headquartered in Israel, close to areas affected by ongoing military conflicts involving Israel, Iran, and the United States that began or escalated in 2025 and 2026.
• European Commission formal investigation announced June 29, 2026 into practices relating to Invisalign clear aligners and iTero intraoral scanners in the European Economic Area for potential abuse of a dominant market position.June 29, 2026
• FDA's QMSR became effective on February 2, 2026 and incorporates by reference ISO 13485:2016.February 2, 2026
• The EU AI Act entered into force on August 1, 2024, with prohibitions applying from February 2025, general-purpose AI obligations from August 2025, and transparency obligations from August 2026; in 2026, targeted amendments deferred high-risk AI system obligations to December 2027 and August 2028 and introduced additional prohibited practices.August 1, 2024
• The Inflation Reduction Act imposes a 1% excise tax on our stock repurchases, net of certain stock issuances.