In an August 14, 2020 response to a letter written on behalf of the American Seniors Housing Association and Argentum, the General Counsel’s office of the Department of Health and Human Services has determined that senior living communities are a “covered person” under the Public Readiness and Emergency Preparedness (PREP) Act, which creates immunity from liability for the administration or use of “Covered Countermeasures” in response to COVID-19 ...
Summary of Public Policy and Prior Amendments The Minimum Fuels Storage Public Policy (the “Public Policy”) was released by Mexico’s Ministry of Energy (“SENER”) on December 12, 2017. The objective is to improve energy security in Mexico and ensure adequate energy supply and competitive prices, through the establishment of mandatory minimum fuel inventories and reporting obligations ...
A bipartisan U.S. Senate committee has asked both the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services to study the proliferation of physician owned distributorships (PODs), citing a lack of regulatory guidance on how these arrangements square with existing federal law ...
In response to questions regarding the legality of Cannabidiol (CBD) oil products, the State of Ohio Board of Pharmacy (Board) announced that only licensed and operating Medical Marijuana Control Program dispensaries may sell CBD oil products. In June, the Board announced the award of 56 provisional medical marijuana dispensary licenses. All of those provisional licensees will have six months to comply with operational requirements in order to obtain a certification of operation (COO) ...
Once their compound patents have expired many blockbuster drugs remain protected by secondary 'method of treatment' patents. The validity and enforceability of these secondary patents can be less certain in many jurisdictions. In Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No ...
Europe’s Finance ministers worked through the night of 20 to 21 February to hammer out the terms of the second Greek bail-out to the tune of EUR 130 bn. While the markets have responded coolly to the deal, ministers remain optimistic that enough has been done to stem the contagion to the rest of the Eurozone. Many experts remain skeptical as to whether the bail-out will be enough to save Greece from ultimately defaulting ...
The Second Circuit Court of Appeals recently granted a petition for interlocutory review to decide whether a violation of the FCA’s first-to-file rule can be cured by filing an amended pleading. Both the D.C. Circuit and Fourth Circuit1 recently addressed this issue, concluding that the plain language of the first-to-file rule precludes amending around the rule ...
In a letter dated April 8, 2011, to the President of the North American Securities Administrators Association (“NASAA”),1 Robert Plaze, Associate Director of the Division of Investment Management of the Securities and Exchange Commission (the “SEC”), stated that the SEC is expecting to adopt final rules implementing various provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) applicable to investment advisers by July 21, 2011 ...
On January 25, 2011, the Securities and Exchange Commission (the “SEC”) proposed new Rule 204(b)‑1 (the “Proposed Rule”) under the Investment Advisers Act of 1940, as amended (the “Advisers Act”), that would implement various provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) by creating a new Form PF for use by the Financial Stability Oversight Council (the “FSOC”) and other regulatory agencies in assessing systemic risks posed to the U.S ...
On November 19, 2010, the Securities and Exchange Commission (the “SEC”) proposed new rules and amendments to existing rules and Form ADV under the Investment Advisers Act of 1940, as amended (the “Advisers Act”), that would implement various amendments to the Advisers Act contained as part of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) ...
In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
SEC Adopts Final Rules on New Internal Control Reporting Provisions of Sarbanes-Oxley Act, and Exhibit Requirements for CEO/CFO Certifications
On June 22, 2011, the Securities and Exchange Commission (the “SEC”) adopted final rules and amendments under the Investment Advisers Act of 1940, as amended (the “Advisers Act”), designed to implement various provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”) ...
Prior to the entry into force of the FDI Screening Regulation on 11 October 2020, there was no EU-wide formalized cooperation among the Member States and the European Commission on these matters. In the EU, the European Commission’s strong expectation is that all 27 EU Member States will put national FDI screening mechanisms in place. A national screening mechanism in all 27 Member States serves to safeguard all individual Member States against potentially risky foreign investments ...
On March 21, 2023, the Supreme Court of the United States heard oral argument in Abitron Austria GmbH, et al. (“Abitron et al.”) v. Hetronic International, Inc. (“Hetronic”)[i] on an issue it has not squarely addressed in seven decades: the extraterritorial reach of the Lanham Act, the comprehensive trademark statute in the United States ...
In a statement to Parliament on 14 December 2021, John Swinney, the Deputy First Minister, confirmed the appointment of Court of Session judge Lady Poole as the chair of the Scottish inquiry into the COVID-19 pandemic. The Scottish Government also announced the terms of reference for the public inquiry on the same date, with the inquiry investigating the period between 1 January 2020 and 31 December 2022. You can read the full ministerial statement here ...
News that London had won the race to host the Olympic and Paralympic Games in 2012 was greeted with delight not only in sporting circles, but also in many commercial ones. Businesses up and down the country rubbed their hands with glee at the thought of a raft of new and exciting commercial opportunities. Importantly, these opportunities are not just the preserve of businesses south of the border, but are also available to Scottish businesses ...
The oil and gas sector has seen significant changes over the past few years, led by a significant reduction in global oil prices. This has increased the focus on operational efficiency and more flexible ways of working collaboratively to alleviate the effects of protracted price deflation ...
From ground-breaking discoveries such as penicillin and insulin, to the development of the MRI body scanner and the creation of Dolly the sheep, the first mammal to be cloned from an adult cell ...
The Scottish financial sector has always punched above its weight due, in large part, to its appetite for innovation and sharp business acumen, which it has successfully exported around the globe. The successful early establishment in Scotland of current account banking and the investment trust speak to this, along with the undisputed influence of the Scottish diaspora, which established many of the great financial institutions from Paris to Hong Kong ...
Many employers currently have employees on staff on temporary work visas, and employers likely know that in order to continue to employ employees not born in the U.S., the employer must sponsor the employee for permanent residency in the U.S. (i.e,. a green card). The green card process has multiple steps, which, depending on a variety of factors, may take several years to complete ...
Will the release of its digital currency be China’s next salvo in its bid for world domination?One of the biggest developments in global finance has recently occurred, but not enough people are talking about it. It features technology, money and a battle between global superpowers ...
December 2015 By: Bailee Pelham "Previous research on the mental health of firefighters has shown that they are at a greater risk than the majority of the population to develop various mental disorders, such as depression, anxiety, alcohol abuse, suicidal ideation, and post-traumatic stress disorder ...
Sarbanes-Oxley Act of 2002: SEC Adopts Final Rule to Mandate Electronic Filing and Website Posting for Forms 3, 4 and 5 As required by Section 403 of the Sarbanes-Oxley Act of 2002, the Securities and Exchange Commission (the “SEC”) has adopted final rules and form amendments mandating the electronic filing, and website posting by issuers with corporate websites, of beneficial ownership reports filed by officers, directors and principal security holders under Section 16(a) of the Securities E
