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) ...
Over the last few years, companies listed on both the primary and secondary market of the Johannesburg Stock Exchange (“JSE”), have been obliged to comply with increasingly onerous and often unclear reporting obligations in respect of the status of their transformation. On 3 February 2021, the B-BBEE Commission offered some clarity, however, there are still uncertainties that need to be addressed for many JSE-listed companies to overcome reporting challenges ...
With the Protection of Personal Information Act, 2013 ("POPIA") deadline closing in on 1 July 2021, many organisations are starting to feel the mounting pressure of becoming compliant with POPIA. A good starting point in any POPIA compliance journey is the appointment of an Information Officer for your organisation. Who is the Information Officer? POPIA, by default, designates the head of any private body as the Information Officer ...
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 ...
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This article forms part of our ‘New How: Perspectives’ report: ‘Can real estate help solve the productivity puzzle?. To access this free report, please click the link below. We all know a happy engaged employee is a productive and successful employee. Unfortunately, the UK has one of the least engaged employee populations in Europe ...
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 ...
The transition period started after the Brexit ended on 1 January 2021. This means that the United Kingdom has officially lost its status as EU Member State. This has implications for competition law and business. What has changed since 1 January 2021? Firstly, the Competition and Markets Authority )CMA) is no longer competent to enforce EU competition law and investigate possible breaches in the United Kingdom ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 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 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 ...
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 ...
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 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 ...
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 ...
