&The U.S. Court of Appeals for the Federal Circuit, in BGT Holdings LLC v. United States, 1 recently held that the government does not have the discretion to deny a contractor's request for equitable adjustment (REA) under Federal Acquisition Regulation (FAR) 52.245-1 (Government Property) where the conditions specified in that clause are present and the contractor is able to show financial loss ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
In Joanne Properties Ltd v Moneything Capital Ltd and Anor [2020] EWCA Civ 1541, England’s Court of Appeal had to decide whether the parties had entered into a binding contract of compromise contained in written communications passing between their respective solicitors. The Court below had held that a binding contract had been made, despite the fact that the correspondence in question had been marked “subject to contract” ...
A recent UK Supreme Court Judgment, the Financial Conduct Authority v Arch Insurance (UK Ltd) & Ors [2021] UKSC 1, clarified whether a variety of insurance policy wordings cover business interruption losses resulting from the COVID-19 pandemic and public health measures taken by UK authorities in response to the pandemic from March 2020 ...
The recent judgment from the Supreme Court of the United Kingdom on Halliburton Company v Chubb Bermuda Insurance Ltd [2020] UKSC 48, raised important questions about the requirement that there can not only be no actual bias, but also no apparent bias on the part of arbitrators in favour of or against any party in arbitration and also about the obligation of arbitrators in international arbitrations to make disclosure of multiple appointments concerning the same or overlapping subje
Following the renewal of the state of emergency, Decree 3-A/2021 of14January of the Presidency of the Council of Ministers, determines the closure of various types of establishments. Inthiscontext, the employment support measures were amended by Decree-Law 6-C/2021 of 15 January and Decree-Law 6-E/2021 of15January, which we summarised below. 1 ...
Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
Traditionally, Dutch mortgage lenders have always found themselves in quite a good position in the event of their borrower and mortgagor becoming insolvent. As a firm general rule, it is fair to say that the position of a secured creditor is quite secure under Dutch law. Recent insolvency and COVID related regulations have, however, made some inroads into the Dutch secured lender’s stronghold ...
In December 2018, section 53.1 was added to the Patent Act (the? Act?) Allowing reference to be made to communications exchanged with the Canadian Intellectual Property Office ("CIPO") During the prosecution of an application with respect? [... ] to the construction of a claim.? This concept is more commonly known as? File wrapper estoppel ...
Dr Michael Psaila, Managing Partner of Mamo TCV Advocates, underlined the firm’s commitment to the visually impaired and the Malta Guide Dogs Foundation (MGDF) in particular when he not only presented a donation but committed the firm to assisting the foundation in its legal affairs in the coming years. It was the wish of the firm, which has a staff complement of over 70 people, to select the MGDF as one of the beneficiaries of their annual charity donation ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
The “right to be forgotten” (“RTBF”) has been central to the global debate over the balance between individual privacy and freedom of information and of the media in recent years. Such right has been affirmed by the European Court of Justice in a milestone case in 2014, as well as later in the UK, although its application in other countries remains uncertain ...
As we continue through Lockdown 3, we are seeing how children can be caught in the middle of family disputes involving separated parents trying to navigate living arrangements between different family bubbles. With that in mind, it appears to be more important than ever within the context of private law children proceedings for the courts and authorities to be alert to the views of the children when determining what should happen ...
1. Background to the case The case concerned a young, female employee in a mechanical workshop, who felt she had been sexually harassed by two of the enterprise’s customers. Customer No 1 had on one occasion, while the female employee was sitting on the floor in a forward-leaning position, performing work, put his hands on her lower back, under her top ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
The Pension Protection Fund (PPF) has published its determination for the levy year 2021 to 2022, following its autumn consultation. Ordinarily, the PPF considers matters across the levy triennium with a view to keeping the rules relatively stable on a triennial basis. However, in considering the impact of COVID-19 on schemes, the PPF wishes to take a more flexible approach with the aim of switching back to a multi-year approach in 2023/24 ...
Bank Negara Malaysia issues Licensing Framework for Digital Banks Bank Negara Malaysia issued its policy document on Licensing Framework for Digital Banks on 31 December 2020. It has indicated in its press release that up to five licences may be issued to qualified applicants and notification of the grant of licence will only be made by the first quarter of 2022 ...
In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S ...
In a decision that could be a game-changer for cookie and candy manufacturers, the Third Circuit has recently denied trade dress protection for the shape of the popular Pocky cookie. The Pocky is a long, thin Japanese cookie stick that is almost completely dipped in chocolate, except for the very bottom. Ezaki Glico created the Pocky in 1966 and obtained two trade dress registrations to protect the configuration of the cookie ...
Domestic extremism is not new, but heightened law enforcement scrutiny in the wake of the Capitol riots has added yet another layer of complexity to the jobs of already challenged AML compliance professionals and investigators ...
On 26 January 2021, the Central Bank of Myanmar (the “CBM”) issued Notification1/2021 (the “Notification”) outlining the requirements and specifications for the establishment, operation and business activities of non-bank financial institutions (“NBFIs”). This Notification is effective from 26 January 2021. 1 ...
Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2020 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. Despite the pandemic and the smallest recoveries for the Department of Justice in over a decade, FCA enforcement remains robust. As always, the healthcare industry remains the most frequent subject of FCA cases and investigation ...
