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National Security & Investment Bill
Shoosmiths LLP, February 2021

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...

Bid Protests in New York
Bradley Arant Boult Cummings LLP, February 2021

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...

The Amicus Brief: An Efficient And Elegant Public Policy Tool
Dinsmore & Shohl LLP, February 2021

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...

China Finally Amends its Patent Law – Part 2: Design
Deacons, February 2021

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...

Electronic Certificates Regulation issued by the Minister of Agrarian Affairs and Spatial Planning/Head of the National Land Agency
Makarim & Taira S., February 2021

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...

The End of the Line for Exclusionary Zoning: Berkeley Set to Make its Move
Hanson Bridgett LLP, February 2021

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...

Two Ways Colleges Can Build Better Paths Toward Student Success
Bradley Arant Boult Cummings LLP, February 2021

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...

Must AstraZeneca Supply the European Union with Sufficient COVID-19 Vaccines under Belgian Law?
ALTIUS/Tiberghien, February 2021

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)...

Bulletin Real Time: Latest News
Brigard Urrutia, February 2021

Modifications to the obligation to disclose information by issuers of securities The National Government issued a new rule that modifies the provisions relating to the obligation to disclose information by issuers of securities, in accordance with the parameters set by the International Organization of Securities Commissions...

Adding up the Numbers: DOJ Announces Its False Claims Act Recoveries for 2020
Dykema, February 2021

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...

Weekly Digest: COVID-19 Resources from Bradley
Bradley Arant Boult Cummings LLP, February 2021

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...

Supreme Court Guidelines on the Conduct of Videoconferencing
SyCip Salazar Hernandez & Gatmaitan, February 2021

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...

SENACON Enacts New Ordinance on Terms for the Adjustment of Conduct (Ordinance n° 34/2021)
Veirano Advogados, February 2021

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...

New Regulation on Electronic System Organizers in the Private Sector
Makarim & Taira S., February 2021

The Minister of Communication and Informatics (“MOCI”) has finally issued MOCI Regulation No. 5 of 2020 on Electronic System Organizers (“ESO”) in the Private Sector (“MOCI Regulation 5/2020”) that serves as the new implementing regulation of Government Regulation No...

The New Indonesian Umbrella Regulation on Payment Systems: Key Points that Foreign Investors Should be Aware of
Makarim & Taira S., February 2021

On 30 December 2020, Bank Indonesia issued Bank Indonesia Regulation No. 22/23/PBI/2020 of 2020 on Payment Systems (“Payment Systems Regulation”). The Payment Systems Regulation is intended to serve as an “umbrella” regulation that provides a regulatory framework for the Indonesian payment systems industry. This regulation will come into force on 1 July 2021...

Indonesia’s Ratification of the Convention Abolishing the Requirement to Legalize Foreign Public Documents
Makarim & Taira S., February 2021

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...

Could This Little-Used FDA Submission Process Help Secure Approval for Your Medical Device?
Dykema, February 2021

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...

Government's Failure to Grant REA Can Constitute Breach of Contract
Bradley Arant Boult Cummings LLP, February 2021

&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...

X-Waiver Changes Axed: Federal Government Backtracks on Previously Announced Rescission of Waiver Requirements
Dinsmore & Shohl LLP, February 2021

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...

Coronavirus: Employment Support Measures
PLMJ, February 2021

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...

FTC Reduces Notice Thresholds Under the Hart-Scott-Rodino Act for 2021, Increases Penalties, and Temporarily Suspends Expedited Review
Schwabe, Williamson & Wyatt, February 2021

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...

Consultation Announced on Changes to the Electronic Communications Code
Shoosmiths LLP, February 2021

The Electronic Communications Code was subject to a wholesale re-write in 2017, with the intention of facilitating the faster roll-out of the UK’s digital communications infrastructure. Three years on, the government has commenced a consultation on proposals to revise aspects of the Code to ensure it is fit for purpose...

New Stark Law Makes Practical Changes to Key Concepts
Dinsmore & Shohl LLP, February 2021

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...

Government Enforcement Update: False Claims Act 2020 Year in Review
Bradley Arant Boult Cummings LLP, February 2021

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...

Acquisition of UAE Nationality
Afridi & Angell, February 2021

The Government of the UAE made another milestone announcement on 30 January 2021, announcing a procedure for the granting of citizenship to foreign nationals in a bid to retain talent in critical sectors and to expand and diversify the economy. Nationality and citizenship in the UAE are governed by Federal Law No. 17 of 1972 Concerning Nationality and Passports, as amended by Federal Law No. 10 of 1975 and Federal Decree-Law No...

 

 

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