Coronavirus Insights & Updates The information listed below is categorized by topic for your convenience and includes content from the previous week. Bradley is actively monitoring and engaging with relevant federal, state or local entities on issues related to the coronavirus. Please contact one of the authors if you have any questions. Click on a link below to view the full article, alert, blog, webinar recording or interview ...
Over the next decade, challenges around public funding and a shift in live/work priorities will create an increasing need for public-private collaboration as we seek to rebuild and regenerate our towns and cities in a post-Covid and post-Brexit climate ...
February marks the start of the second month after Brexit materializing. The Member States have finally understood that the United Kingdom (UK) is no longer in the Europen Union (EU) so that the fairy-tale of the Single Market that has lasted for decades is now over. Although many businesses resolved various legal or regulatory issues before 1st January, new challenges inevitably keep arising now, when Brexit is a reality ...
As a developing country, Indonesia is still considered to have limited Government fiscal capacity and limited state-owned enterprise (Badan Usaha Milik Negara – “BUMN”) and financial sector funding capacity indicating that domestic capacity is not sufficient to meet what is needed to finance development and support economic growth and opportunities ...
In recent years, with the continuous improvement of science and technology standards in China, the country’s cryptography technical capabilities have also begun to enter the global forefront. In turn, China has promulgated various policies and measures to fulfill its non-proliferation obligations, which have promoted the gradual implementation of control measures for the export of cryptographic technologies ...
On 4 January 2021, the President of Republic of Indonesia issued Regulation No. 2 of 2021 on the Ratification of the Convention Abolishing the Requirement to Legalize Foreign Public Documents (“PR 2/2021”) (the convention is hereinafter referred to as the “Apostille Convention”). The Apostille Convention was concluded on 5 October 1961 and is intended to simplify a series of formalities for documents signed overseas for the contracting states ...
The with backdrop of a global pandemic, John Hartley looks at the modern structure of global corporate investigations. It is a small world and getting smaller. The speed at which COVID-19 spread across the world when most easily transmitted by being within two meters of each other is a clear indication of just how small the world is getting ...
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 ...
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 ...
Early last year the Prime Minister dropped the “E-bomb” on British motorists, announcing a ban on cars powered wholly by petrol and diesel from 2030, and on the sale of new hybrid vehicles with the capability to drive a significant distance with zero emissions (such as plug-in or full hybrids) from 2035. Since then, the COVID-19 pandemic has impacted the world in an unprecedented manner ...
The owners of multistate businesses must consider many factors when deciding how to structure their business ventures, and state taxation should not be overlooked. The accompanying tables can assist in that evaluation for limited liability companies and limited liability partnerships. In recent years, LLCs and, to a lesser extent, limited partnerships and LLPs have become the popular choice for structuring or restructuring multistate business entities ...
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 ...
On January 25, 2021, the German federal Cabinet introduced the draft for the new Cyber Security Act (“IT Security Act 2.0”) into the legislative process ( Draft of a Second Act to Increase the Security of Information Technology Systems, printed matter 19/26106 [draft of a second law to increase the security of information technology systems, document 19/26106] ). The new German Cyber Security Act is intended to replace the old German Cyber Security Act of July 2015 ...
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 Oil Can published an article by Dinsmore partner Mark Boos this week in its Spring 2021 edition about the importance of indemnification provisions are essential in commercial contracts, an excerpt of which is below. Indemnification provisions are part of virtually every commercial contract. Ironically, they’re also among the contract elements most likely to be overlooked by the parties ...
On February 1, 2021, the Federal Trade Commission (FTC) announced its revised annual threshold that determines whether companies may be required to notify federal antitrust authorities about a proposed merger or acquisition due to the size and value of the transaction. For the first time since 2010 and a reflection of the state of the economy, the annual threshold has been reduced rather than raised, from $94 million in 2020 to $92 million for 2021 ...
Aron Beezley of Bradley Arant Boult Cummings LLP enumerates the key impacts of the Federal Acquisition Regulation Council's final rule adopting mandates of the executive order Maximizing Use of American-Made Goods, Products, and Materials. The Federal Acquisition Regulation (FAR) Council recently issued a final rule1 that implements the requirements of the Maximizing Use of American-Made Goods, Products, and Materials Executive Order ...
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 ...
Pursuant to the Prevention and Suppression of Money Laundering Activities Law (the “AML Law”), which transposes into national legislation the 4thEU AML Directive ((EU) 2015/849), companies and other legal entities must maintain and register, in a central public register to be created for this purpose, information on their beneficial owners ...
When it comes to the general transfer of data to third countries, even, for example, intra-group data transfers, recourse to US providers such as Microsoft (Office 365), Amazon (AWS), Google or Salesforce has been ill-fated since the ECJ ruling of July 16, 2020 (C-311/18 “Schrems II”) ...
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 ...
