Introduction The rapid spread of COVID-19 pandemic has led to a significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), masks for social use (textile articles) and other products destined to prevent the spread of the disease. As a result, it became clear that there was insufficient supply to meet existing needs during the state of emergency and the subsequent period ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
The 2020 election in California as pertains to national politics was never in doubt, but despite being a deeply blue state, Californians continued to show their divide on taxing businesses and making major changes to the statewide tax code. Several ballot initiatives, both at the state and municipal level, would have radically altered how businesses and executives are taxed ...
On November 2, 2020, the Securities and Exchange Commission voted to harmonize, simplify, and improve the current tangled framework for exempt securities offerings, a move intended to promote capital formation and expand investment opportunities while preserving or improving important investor protections. Under SEC requirements, all securities offerings must be either registered with the SEC or qualify for an exemption from registration ...
After months of predictions of a possible Democratic wave,Tuesday’s election delivered mixed results. Joe Biden appears poised to narrowly defeat President Trump after one of the most contentious election cycles in recent memory. Republicans are favored to retain their Senate majority despite having to defend twice as many seats as their Democratic counterparts ...
On November 9, 2020, the federal government announced a further temporary extension to permitted layoff periods for federally regulated private-sector employees. Background In June of 2020, the federal government extended the time periods for layoffs under the Canada Labour Standards Regulations to allow federally regulated private-sector employers more time to recall laid-off employees ...
Effective Nov. 9, 2020, the Securities and Exchange Commission’s (SEC) amendments to “modernize the description of business, legal proceedings, and risk factor disclosures” required under Regulation S-K take effect. These amendments largely follow the proposed amendments, dated Aug. 8, 2019,[1] with some clarifications. The intent of the amendments is to improve the disclosure regime, which has not had a major overhaul in over thirty years ...
While a few legislative races are still being tabulated, Democrats maintained their supermajority status in both the Illinois House of Representatives and Senate in this election cycle. Current projections, that are subject to change pending mail-in ballots, are for a Democrat supermajority of 72-46 in the House and 41-18 in the Senate. This was not an unexpected outcome, though most pre-election predictions had the Democrats achieving an even wider gap in the Legislature ...
While yesterday’s federal election results from West Virginia were not a surprise, the down ballot races, especially for the State Legislature, clearly demonstrated what was a strong red wave that engulfed incumbents, swept away open seats, and cemented what may be durable majorities in both chambers for years to come. As around the country, early voting enthusiasm also gripped West Virginia ...
If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20) ...
The Coronavirus pandemic has caused a shift in the paradigm of modern-day workplaces. Companies across the globe have seen a rapid and widespread shift to remote work, making compliance with the GDPR harder than ever. The Federal Office of Information Security (BSI), in its recent report on the ‘State of IT Security in Germany 2020’, expressed its concern and indicated a ‘tense situation’ for data protection in the country ...
Belgium is, for the second time, in lockdown. The new Ministerial Decree of 1 November 2020 stipulates that, as from today until 13 December 2020, all workers are obliged to telework. However, an exception applies when either the employee’s role or the continuity of business operations, activities and services does not allow for teleworking ...
On Oct. 26, 2020, the IRS announced in Notice 2020-79 cost of living adjustments (COLAS) to the qualified plan dollar limits for 2021. Below is a summary of the limits that are generally relevant for most retirement plans. Effective Jan. 1, 2021: The elective deferral limit for 401(k), 403(b), and eligible 457(b) plans is unchanged at $19,500. The catch-up contribution limit for those aged 50 or older remains stable at $6,500 ...
On 30 September 2020, the Royal Government of Cambodia (“RGC”) issued a press release and rolled out ‘Round 6’ of measures aimed at mitigating the impacts of COVID-19 on businesses and workers in Cambodia. These represent a combination of new and existing measures (that have been extended) ...
On October 20, 2020, San Francisco County was upgraded to the “minimal” tier within the California COVID-19 tracking system, meaning it has the fewest restrictions on reopening all businesses as promulgated by the State of California. In order to qualify for the “minimal” tier, a county must have an infection rate of less than one daily new positive COVID case per 100,000 residents and have a positive test rate of less than 2% for two consecutive weeks ...
The Armed Services Board of Contract Appeals (the “Board”) recently held the government liable for design delays where the government prematurely required details in design submissions and failed to provide comments on design submissions within the 14-day period allotted for government comments in the contract. In Appeal of RBC Construction Corp., the contract contemplated the use of fast track design methods ...
In Appeal of Watts Constructors, LLC, the Armed Services Board of Contract Appeals (the “Board”) held that a contractor was not excused from following contract plans and specifications despite the observation by government quality assurance inspectors of non-compliant electrical work during installation ...
When crafting a liquidation or “pass-through” agreement for a subcontractor claim against the government, the key provision from the prime contractor’s perspective is a release from liability for the subcontractor’s claim with the exception of amounts recovered from the government related to that claim. If the release language is too broad, however, the agreement may provide the government a legal defense to the pass-through claim known as the Severin doctrine ...
On Sept. 3, the U.S. Department of Housing and Urban Development (HUD) issued its final rule on the implementation of the Fair Housing Act’s disparate impact standard. The Fair Housing Act (FHA) prohibits discrimination in many housing-related activities on the basis of race, color, religion, sex, disability, familial status, and national origin ...
The U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) released an interim final rule on October 29, 2020, delaying the implementation of the information blocking rule under the 21st Century Cures Act (Information Blocking Rule) ...
On October 29, the OCC, the Federal Reserve, the FDIC, the NCUA and the CFPB (collectively, the “agencies”) issued a Notice of Proposed Rulemaking (“NPR”) to clarify and make into a rule the prior Interagency Statement Clarifying the Role of Supervisory Guidance issued on September 11, 2018 (“2018 Statement”). Comments on the NPR are due within 60 days of the date the NPR is published in the Federal Register ...
Due to the dramatic increase in Covid-19 infection numbers, there were calls – once again – to postpone the social elections that are scheduled for the period between 16 and 29 November 2020. However, on 27 October 2020, the social partners reached an agreement not to do so, but to extend the opportunities for voting electronically or by post so that the elections can take place in Covid-proof circumstances ...
The U.S. Department of Justice (DOJ) announced on October 29, 2020 it reached a more than $9.2 million settlement with Medtronic USA Inc. to resolve allegations it violated the False Claims Act (FCA) and Open Payment Program.[1] Specifically, Medtronic agreed to pay $8.1 million to resolve FCA allegations it paid kickbacks to induce a South Dakota neurosurgeon to use its SynchroMed II intrathecal infusion pumps ...