News & Analysis as of

Supply Chain

The French Duty of Vigilance Law: What You Need to Know

As previously noted, on February 21, 2017, the French National Assembly adopted a law establishing a “duty of vigilance” for large multinational firms carrying out all or part of their activity in France. In a subsequent...more

Procurement Pressure: The Convergence Of Supply And Compliance

by Thomas Fox on

With a growing number of complex regulations and directives, the only thing that is constant right now in the regulatory environment is change. Supply chain leaders and compliance professionals alike continue to grapple with...more

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Day 7 of One Month to More Effective Continuous Improvement-the Supply Chain Audit

by Thomas Fox on

In my last corporate position, my company was at the cutting edge because we required compliance related audits for vendors in the supply chain. This was cutting edge in 2007-08. However, now an audit for adherence to...more

Survey of 2016 Conflict Minerals Filings Released

Development International has released its annual survey of conflict minerals reports for the 2016 reporting period which were filed in 2017. Despite the SEC’s no action position which relaxed conflict minerals reporting...more

Example GDPR ready processor terms

by DLA Piper on

One of the larger tasks facing organisations as they prepare for the new EU General Data Protection Regulation 2016/679 is how to tackle data governance and compliance controls in the supply chain. This is often the Achilles...more

Suppliers Beware: Two Recent Cases (in Third Circuit and Delaware) Hold that Debtor Must Physically Possess Goods Within Statutory...

Amidst a surge in retail bankruptcies, two recent decisions construing section 503(b)(9) of the Bankruptcy Code directly limit suppliers’ ability to seek administrative claims for goods shipped to a debtor in the period...more

Coty: Selective distribution and the luxury of prohibiting third party platform sales

by DLA Piper on

With the meteoric rise in internet selling, the permissibility of banning selective distributors from selling via "third party platforms" is a hotly debated topic across the EU, particularly in Germany and Austria. In...more

Lessons in Failures of Internal Controls

by Thomas Fox on

Last week’s announcement by the Securities and Exchange Commission (SEC) of the resolution of its outstanding Foreign Corrupt Practices Act (FCPA) enforcement action with Halliburton Company continues to resonate and provide...more

Using a Human Rights Lens to Strengthen Your Anti-Corruption Compliance Program

Companies are increasingly expected to manage the human rights impacts of their activities. This expectation is embedded in new legislative requirements, in the requirements of business partners and investors, and in the...more

Legal and regulatory issues adversely affecting banks in Trade and Supply Chain Finance

by Sullivan & Worcester on

Following a meeting of the Basel committee in March this year, the Chairman Stefan Ingves, announced that the committee has made further progress towards the finalization of the Basel III accord are stricter capital rules and...more

WTO and FAO Issue Publication on Trade and Food Standards

by Kelley Drye & Warren LLP on

The World Trade Organization (WTO) and the UN Food and Agriculture Organization (FAO) recently issued a joint publication, Trade and Food Standards, which discusses the development of international standards and the need for...more

You're Always a Day Away: DSCSA Product Identifier Requirements Delayed

by Arnall Golden Gregory LLP on

In recently issued draft guidance related to the implementation of product identifiers under the Drug Supply Chain Security Act ("DSCSA"), FDA has stated that it intends to exercise enforcement discretion for a period of one...more

FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act

by Hogan Lovells on

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more

Taking Advantage of the Global Supply Chain for Patent Examination

by Ward and Smith, P.A. on

Innovation and Traditional Patent Process - When you develop an innovation, its potential patentability is typically unknown, thus making it difficult to determine whether it is worth the significant expense involved if...more

New guidance for lawyers advising businesses on human rights risks

by DLA Piper on

On 17 July 2017, the International Bar Association Legal Policy and Research Unit (LPRU) released a Handbook for Lawyers on Business and Human Rights to provide guidance for business lawyers and their corporate clients on how...more

The False Claims Act: Why It Is Relevant To All Manufacturers

The False Claims Act (FCA) is a major civil enforcement tool used by the federal government to redress fraud causing monetary loss to the government. In the 2016 fiscal year, the federal government recovered over $4.7...more

Conflict Minerals – The European Drive for Greater Supply-Chain Transparency Continues

by Allen & Overy LLP on

The EU has finally adopted new transparency rules regarding so-called conflicts minerals being imported into the EU. This follows a series of policy initiatives from the European Commission to drive for greater transparency...more

Australia’s Consideration of a New Modern Slavery Act: What You Need to Know

Corporate counsel must increasingly assess the implications of new transparency statutes that require companies to make public disclosures as to their efforts to address certain human rights-related risks in connection with...more

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

Supply Chain Disruption and Litigation Trends in North Africa's Oil and Gas Industry

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells partner Laurent Gouiffès discusses oil and gas supply chain disruption and litigation trends in North Africa, including Algeria, Libya, Tunisia, Morocco, and Egypt....more

Takata Declares Bankruptcy: What are the Key Next Steps for Suppliers?

by Foley & Lardner LLP on

On June 25, 2017, Takata’s US arm, TK Holdings Inc. and certain affiliates excluding certain foreign debtors such as Takata Corporation (Japan) (the “Takata US Debtors”), filed chapter 11 cases seeking bankruptcy protection...more

FCPA COMPLIANCE REPORT-EPISODE 337, JAMES GELLERT ON ASSESSING 3RD PARTY FINANCIAL HEALTH FOR COMPLIANCE

by Thomas Fox on

In this episode, I visit with James Gellert, CEO of RapidRatings, a company which uses a financial dialogue to determine third party supplier health and viability. Gellert explains what supply chain resilience is and how...more

FSMA: What Every Food Industry Executive Should Do & Why

by Strasburger & Price, LLP on

With six of the seven rules implemented under the 2011 Food Safety Modernization Act (FSMA) currently being enforced, what should you know and do? Here are some considerations for facilities that manufacture, pack, process,...more

How Life Sciences and Pharmaceutical Companies Can Harness Opportunity in Their Supply Chains

by Hogan Lovells on

In this hoganlovells.com interview, Hogan Lovells counsel Penny Powell talks about disruptive technologies, the increasing trend towards collaboration and joint venture agreements, the opportunities and regulatory burdens...more

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