A Ringside View
Sitting with the C-Suite: Identifying Opportunities to Leverage Human Capital
Outsourcing Fuels The Future Of Oil & Gas
Frenemies: Gaining Efficiency Through Shared Services
FCPA Compliance and Ethics Report-Episode 146-David Simon on Foley's Global Risk Management Platform
With ever-increasing threats from the Chinese Communist Party, recently exposed vulnerabilities in the United States' supply chain and decades of outsourcing that has left the defense and industrial base vulnerable, there is...more
On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and...more
Outsourcing the design and manufacturing of products, components and software to foreign contractors has become a significant part of manufacturing in the U.S. However, if the items involved are subject to U.S. export...more
After deciding on the basic corporate or contractual structure, the company should decide how best to strategically divide the manufacturing process. In the outsourced manufacturing context, the best process involves not only...more
Transaction Structure - Once the company selects a potential outsourced manufacturing partner, it should design a transaction structure that reinforces its commercial expectations and the manufacturer’s contractual...more
Perhaps the single most important part of outsourced manufacturing is to select a trustworthy partner. A company should not enter into any transaction unless it has a good basis to believe that the manufacturer will be an...more
When a company, for the soundest of business reasons, is exploring placing its crown jewels, its intellectual assets, in the hands of a third party, proper internal controls are vital. A company’s internal controls may...more
Nearly all manufacturing processes involve a significant number of intellectual assets. These assets may include registered intellectual property (designs, patents, copyrights, or trademarks) or unregistered trade secrets,...more
There are two common categories of outsourced manufacturing: toll manufacturing and contract manufacturing. While both these manufacturing options have distinct and clear characteristics, their strategic advantage is their...more
Since the beginning of the industrial age, companies have outsourced part of the manufacturing process to third-party providers. In the twentieth century, as manufacturing processes became more complex and distribution more...more
There has been a lot of talk about “reshoring” in the wake of COVID-19. Reshoring can take many forms. It usually refers to a company moving manufacturing facilities or services back to the United States. Other times, it...more
With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more
Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of...more
Pharmaceutical outsourcing has emerged as a robust—and rapidly growing—subsector of the life sciences industry. As the push for efficiency continues, more pharmaceutical, biotech and medtech companies are turning to contract...more
The Ohio Supreme Court has held that services provided by a staffing agency (Seaton Corp) to a manufacturer were not taxable when the staffing agency provides on-site management. The controversy centered on whether Seaton...more
November 27, 2018 marked five years since President Obama signed the Drug Quality and Security Act (DQSA) into law. The law addresses two distinct areas of drug oversight, but it was the combined concerns about the quality...more
Pharmaceutical and Life Sciences companies operate in a demanding environment and face diverse challenges such as pricing pressure, increased regulatory requirements and mounting costs. With this backdrop, they have, starting...more
In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more
The demise of American manufacturing has been widely heralded. However, in a report on the state of manufacturing in America, economist Michael J. Hicks of the Center for Business and Economic Research at Ball State...more
In this episode, I visit with David Simon, a partner at Foley and Lardner. We discuss Foley's recently recently Global Risk Management Platform. ...more
In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more
More than a decade after the outsourcing trend reached its peak, a new trend, reshoring, is quickly gaining momentum in the manufacturing industry. For a variety of reasons, manufacturers are bringing production and the...more
In recent decades, companies seeking to reduce manufacturing costs and improve profit margins have increasingly employed contract manufacturing – that is, the outsourcing of partial or complete manufacturing of products to...more