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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 ...

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 ...

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 ...

Afridi & Angell | February 2021

New measures to curb the “second wave” of COVID-19 cases have been introduced by the Dubai Supreme Committee of Crisis and Disaster Management (the Dubai Committee) and the Abu Dhabi Emergency Crisis and Disasters Committee for COVID-19 Pandemic (the Abu Dhabi Committee) ...

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 ...

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) ...

ALTIUS/Tiberghien | February 2021

Introduction On 21 January 2021 a new royal decree was published in the Official Gazette which has temporarily extended occupational doctors' role in combating the COVID-19 pandemic in the workplace ...

ALRUD Law Firm | February 2021

We would like to inform you about several important news items, in the pharmaceutical industry, at the beginning of 2021. The Rules of registration and assessment of medicines for medical use in the EAEU come into force According to the Decision of the Eurasian Economic Commission Council (“EEC”), dated November 3rd 2016 No ...

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 ...

PLMJ | February 2021

The judgment of the United Kingdom Supreme Court On 1 May 2020, the Financial Conduct Authority (“FCA”), the body that oversees the insurance industry in the United Kingdom, announced that it wanted to obtain a ruling from the English courts on the meaning and effect of the sample of business interruption clauses that it selected from eight insurers in particular ...

PLMJ | February 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 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 ...

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 ...

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 ...

Carey | February 2021

Executive Summary On February 5th, 2021, the Ministry of Economy published the final version of the Regulation on Voluntary Procedures, which is processed before the National Consumer Service, for the protection of collective or diffuse interests of consumers ...

&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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

Deacons | February 2021

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 ...

PLMJ | February 2021

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 ...

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