It’s been more than a year since the COVID-19 pandemic began, and many companies are attempting to market products intended to help consumers deal with the risks associated with COVID-19. Some of the most common examples of such products include face masks, testing devices, hand sanitizers, and hard-surface disinfectants ...
The Federal Acquisition Regulation (FAR) Council recently issued its long-awaited final rule1 limiting the ability of civilian agencies to use the Lowest Price Technically Acceptable (LPTA) procurement method. The final FAR rule — which took effect on February 16, 2021, and largely tracks the language contained in the Defense Federal Acquisition Regulation Supplement (DFARS) final rule from 2019 2 — is codified at FAR 15.101-2 ...
With the new year comes a new president. Will the new year and administration also bring new water policy? Bet on it. Just as President Trump undid President Obama’s signature water policy decision—the Clean Water Rule, which clarified and arguably expanded federal water permitting jurisdiction—President Biden is likely to rewind many of President Trump’s water policy (and, more generally, environmental policy) decisions over the next four or more years ...
On 25 February, 2021 the triumvirate of European Supervisory Authorities, the EBA, EIOPA and ESMA (the "ESAs") published a joint statement on the effective and consistent application and national supervision of the Sustainable Finance Disclosure Regulation ("SFDR"). The joint statement is intended to help mitigate the risks of divergent application of the SFDR, and promote a level playing field to protect investors ...
San Francisco Superior Court Judge Ethan Schulman ruled yesterday that Cal/OSHA can continue to enforce its COVID-19 Emergency Temporary Standard Regulation (ETS), at least for now. On February 25, 2021, Judge Schulman issued an order denying Plaintiffs' applications for a preliminary injunction halting enforcement of the Cal/OSHA's COVID-19 Emergency Temporary Standard Regulation (ETS) in two cases ...
It’s been more than a year since the COVID-19 pandemic began, and many companies are attempting to market products intended to help consumers deal with the risks associated with COVID-19. Some of the most common examples of such products include face masks, testing devices, hand sanitizers, and hard-surface disinfectants ...
The UK Government has published the National Security and Investment Bill – a proposed law that will introduce a screening process for certain acquisitions and investments and which is expected to come into force as early as April 2021. The National Security and Investment Bill has now had its second reading and is expected to come into force as early as April 2021. We take a look at what it will cover ...
On 24 February 2021, the Finance Secretary Paul Chan delivered the 2021-22 Budget which highlighted upcoming government initiatives to promote the establishment of and re-domiciliation of offshore funds to Hong Kong using the Hong Kong open-ended fund company structure (OFC) ...
Regarding the Public Tender Process for the supply of energy and power to distribution companies that will take place this year (“2021/01 Tender Process”), please consider the following: On December 21, 2020, the National Energy Commission (CNE) approved the definitive Tender Rules for this process (the "Rules"), by means of the Exempt Resolution No. 478 ...
Bradley attorneys Aron Beezley and Nathaniel Greeson highlight the administrative bid protest landscape in New York given the state's abundant acquisition economy. New York state's budget is the second largest in the country, and with it, New York has some of the most developed state acquisition laws and procedures in the country. Accordingly, New York provides comparatively robust bid protest rights when it comes to state-level bid protests ...
In its most recent issue, For The Defense published an article by Dinsmore partner Richik Sarkar’s called "The Amicus Brief: An Efficient And Elegant Public Policy Tool." The article examines how, when properly employed, an amicus brief can be the best tool to effect lasting change for the benefit of the amicus and similar parties, industries, and legal interests. An excerpt is below ...
Did you know? China’s new patent law, which comes into effect on 1 June 2021, will significantly change the design patent regime and will see the introduction of partial design protection, the extension of the design patent term from 10 years to 15 years and the acceptance of domestic Chinese design patent filings as a basis for priority ...
With the main goal of the EU being to cut CO2 emissions in order to become carbon neutral by 2050, offshore represents valuable “available space” for the development of clean energy projects. While in some cases offshore is already a crowded place, other offshore locations are still free of significant energy infrastructure. Therefore, planning ahead is more important than ever ...
On 12 January 2021, the Minister of Agrarian Affairs and Spatial Planning/Head of the National Land Agency (“MOA”) issued Regulation No.1 of 2021 on Electronic Certificates (“MOA Reg. 1/2021”). This new regulation is intended to optimize the use of information and communication technology by implementing electronic-based land services and thus improve public services and the ease of doing business. Under MOA Reg ...
Key Points Later this month, the Berkeley City Council is expected to consider ending exclusionary zoning by December 2022. The city has a long history of implementing single-family zoning, which encourages more expensive stand-alone homes that are often inaccessible to disadvantaged populations. The shift would place Berkeley, which in 1916 became the nation's first city with single-family zoning, at the forefront of a modern era of inclusionary housing policy ...
Like every other higher education leader, I spent most of the last 10 months reacting to the operational imperatives driven by the COVID-19 crisis. Each day presented a novel crisis, and just when we thought we’d see no more plot twists, a new one emerged. In the midst of that maelstrom and as the state’s higher education chief, I often found myself trying to find elusive time to process what these daily crises meant for our enterprise over the long term ...
In January 2021, the U.S. Dept. of Justice (DOJ) announced $2.2 billion in False Claims Act (FCA) recoveries for fiscal year 2020, which ended on September 30.[1] Although this amount is substantial, it nonetheless represents the smallest recovery figure in 10 years. These figures reflect the Trump administration’s unaggressive enforcement efforts and its restrictive view of the FCA. As recently as 2016, FCA recovery exceeded $4.5 billion. Recoveries in 2019 were $3 ...
To the extent that there is such a thing as a “HIPAA Day,” it’s coming up soon. And, no, it’s not a HIPAA Holiday. Instead, March 1 is the deadline to report all HIPAA breaches of fewer than 500 affected individuals. HIPAA requires all breaches to be reported to the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) ...
Introduction On 27 August 2020 the European Commission, on behalf of EU member states, entered into an advance purchase agreement (APA) with AstraZeneca for the production, purchase and supply of the Anglo-Swedish company's COVID-19 vaccine in the European Union.(1) The APA provides for: AstraZeneca's supply of 300 million doses of its COVID-19 vaccine (the initial Europe doses); and an option for the European Union to order an additional 100 million doses (the optional doses) ...
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 ...
A new ordinance enacted by SENACON became effective on February 5 bringing changes to the execution of Terms for the Adjustment of Conduct (“TAC”) in administrative proceedings before SENACON, revoking the previous ordinance. The ordinance provides for several phases in the process of execution of a TAC, which will begin with a request, analysis of the feasibility of the negotiation, the negotiation itself, followed by authorization and subsequent decision ...
The Supreme Court has issued Supreme Court Administrative Matter No. 20-12-01-SC (Re: Proposed Guidelines on the Conduct of Videoconferencing) dated December 9, 20201 (Court Videoconferencing Guidelines) to ensure that hearings via videoconferencing are conducted in an orderly manner and that the constitutional rights of the accused are protected ...
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 ...
