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Manufacturers Dispute Resolution

Clark Hill PLC

3 key steps before signing a manufacturing NDA in China

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If your company is working with Chinese manufacturers to produce goods or prototypes, you’ve likely encountered a non-disclosure agreement (NDA) along the way. But many companies don’t realize that standard U.S. NDAs are...more

Kerr Russell

Is Your Supply Contract Built for Disruption? A Framework for Resilience

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What once seemed like temporary disruptions have become a persistent reality, challenging financial forecasts and threatening operational stability. Meticulous planning can be undone overnight by a single supplier’s inability...more

Gray Reed

Manufacturing Matters: Change Orders

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Manufacturing construction is booming across Texas in early 2025, with Samsung’s landmark $17 billion semiconductor facility in Taylor, Texas leading the charge as part of a broader trend concentrated along major metro areas...more

Miller Canfield

Arbitrator Selection in International Automotive Supply Chain Disputes

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International automotive supply chains often involve tight just-in-time deadlines, so resolving disputes quickly and efficiently is critical. When arbitration is the designated resolution method, the arbitrator’s...more

Mandelbaum Barrett PC

Preventing and Resolving Construction Disputes: Understanding Liability

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Construction projects involve many moving parts, and when things go wrong—such as defects or failures—it’s crucial to understand who may be liable. Whether you’re a contractor, designer, owner, or manufacturer, each party has...more

A&O Shearman

The new product liability

A&O Shearman on

On October 10, 2024, the Council of the EU adopted the new EU Directive on Liability for Defective Products, which replaces the previously applicable Product Liability Directive of 1985, thereby fundamentally changing the...more

McDermott Will & Emery

This Week in 340B: July 2 – 8, 2024

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

McDermott Will & Emery

This Week in 340B: May 14 – May 20, 2024

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

ArentFox Schiff

New ADR Rule to Govern Disputes Between 340B Covered Entities and Drug Manufacturers

ArentFox Schiff on

Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more

McDermott Will & Emery

HHS Issues 340B Administrative Dispute Resolution Final Rule

McDermott Will & Emery on

On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more

Polsinelli

HRSA Aims for Swift Dispute Resolution with new 340B ADR Final Rule

Polsinelli on

On April 18, 2024, HRSA released its 2024 340B Administrative Dispute Resolution (ADR) Final Rule (2024 ADR Final Rule) and it is largely favorable to covered entities (CEs) with pending ADR claims against drug manufacturers....more

Spilman Thomas & Battle, PLLC

The Site Report - Construction Industry Insights, Issue 4, April 2024

Welcome to our fourth issue of 2024 for our construction industry insights e-newsletter - The Site Report. In our Ask the Attorney segment at the bottom of this e-newsletter, we introduce you to Todd Biddle, Member in...more

K&L Gates LLP

Litigation Minute: Ethylene Oxide—Where Regulators Are Going and How We Got Here (Ethylene Oxide Series: Part Three of Four)

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What You Need to Know in a Minute or Less - While ethylene oxide (EO) has long been subject to federal regulation, the U.S. Environmental Protection Agency (EPA) has recently sharpened its focus on EO emissions. Despite...more

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

Foley Hoag LLP on

On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

Foley Hoag LLP

HRSA ADR Panel Dismisses NACHC's 340B Complaint Against Two Drug Manufacturers

Foley Hoag LLP on

The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...more

K&L Gates LLP

The $363 Million Dollar Question: Are Your Ethylene Oxide Emissions a Litigation Target?

K&L Gates LLP on

On 19 September 2022, a Cook County, Illinois jury awarded US$363 million to a plaintiff who alleged that her breast cancer was caused by emissions of ethylene oxide (EtO) from a Sterigenics facility in Willowbrook, Illinois....more

Foley & Lardner LLP

USMCA's Panel on Automotive Rules of Origin and What It Could Mean to Manufacturers in the Region

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As covered by the news, Mexico and Canada have joined forces to challenge the United States’ strict interpretation of some of the United States-Mexico-Canada Agreement´s (USMCA or Agreement) Automotive Rules of Origin (ROO)....more

McDermott Will & Emery

340B in 2021: What Covered Entities and Their Partners Need to Know Now

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Since March 2010, increased growth in the 340B Program has been accompanied by increased scrutiny from state and federal governments and conflicts between various 340B Program stakeholders. A transition in U.S. Department of...more

King & Spalding

Federal Judge Blocks Implementation of 340B ADR Final Rule

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On March 16, 2021, a federal judge issued a preliminary injunction blocking HHS from implementing the 340B administrative dispute resolution final rule (the Final Rule) released in December 2020. The blocked Final Rule would...more

McDermott Will & Emery

[Webinar] 340B in 2021: What Covered Entities and Their Partners Need to Know Now - March 18th, 2:00 pm - 3:00 pm ET

McDermott Will & Emery on

This must-attend webinar will give 340B covered entities and their partners up-to-the-minute insights into the most pressing issues affecting their business today and the trends that will shape the market tomorrow. Our...more

Hinshaw & Culbertson - Health Care

Change is on the Horizon for 340B Pharmacy Program's Administrative Dispute Resolution Process

The U.S. Health Resources and Services Administration (HRSA) published a final rule (the Rule) on December 14, 2020, which outlined the requirements and procedures for the 340B pharmacy program's administrative dispute...more

Verrill

340B Providers Get Partial Relief from New Dispute Resolution Regulation

Verrill on

1. 340B ADR Process Established - At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical...more

Jackson Lewis P.C.

Four Ways Manufacturing Employers Can Reduce Risk Of Class Action Litigation

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While most employers’ collective bargaining agreements (CBAs) require that class action grievances be submitted to an arbitrator for adjudication, employers in the manufacturing industry may want to consider extra precautions...more

K&L Gates LLP

340B Update: HRSA Moves Forward with 340B ADR Rule as Covered Entities Challenge Contract Pharmacy Actions

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In this episode of Triage, Andrew Ruskin and Victoria Hamscho provide an update on recent developments in the 340B Program and, in particular, on two recent legal challenges covered entities brought in response to drug...more

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