On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
In response to the coronavirus pandemic, the federal government passed the CARES Act, which provides a number of protections to homeowners unable to pay their mortgages. The CARES Act prohibits any home foreclosures before December 31, 2020, and allows homeowners to seek forbearance from lenders for a period of 180 days, with one extension of 180 days. The Act applies to all federally backed mortgages ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
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 CARES Act provided historic, temporary relief to mortgage holders facing Covid-19-related financial troubles. R. Aaron Chastain, partner at Bradley Arant Boult Cummings LLP, looks at where mortgage lenders and servicers stand as the pandemic continues and federal agencies and state governments continue to adjust compliance requirements and rules ...
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 supply of undeveloped (bare) land is exempt from value added tax (VAT) pursuant to Article 46 (3) of UAE Law No 8 of 2017. Bare land (as opposed to covered land) is defined as ‘land that is not covered by completed, partially completed buildings or civil engineering works’ pursuant to Article 44 of Cabinet Decision 52 of 2017 ...
Michigan has joined the majority of jurisdictions in holding that a general liability policy may provide coverage for claims for property damage allegedly caused by the defective work of a subcontractor ...
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 ...
It is rare for the holding in a single criminal case to have such far-reaching implications that it affects nearly every industry in a particular state. But that is what happened on July 9, 2020, when the United States Supreme Court overturned Jimcy McGirt’s criminal conviction in Oklahoma state court by holding that Oklahoma did not have jurisdiction to prosecute McGirt (a citizen of the Creek tribe) for a crime committed within the boundaries of the Creek Nation ...
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 ...
On page 8 of the September–October issue, we discussed the COVID-19 forbearance landscape and related compliance challenges for mortgage servicers. In this article, we unpack the post-forbearance world, focusing on the transition out of forbearance and into other forms of loss mitigation assistance, including, but not limited to, payment deferrals, repayment plans, loan modifications, etc ...
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 ...
The coronavirus disease (COVID-19) outbreak continues to put pressure on the public and private sectors alike. As we are entering new phases of the COVID-19 pandemic, we have to switch our focus towards safely and gradually reopening our businesses and economies while continuing to implement prevention measures ...
Facing Australia's first recession in 30 years, Australian businesses are attempting to steer a course not only for survival but for the growth needed to be a viable long term. But alongside uncertainty comes opportunity. Our new report, prepared in partnership with Acuris, explores the key steps for companies and investors to take advantage of the opportunities – and decisive, informed and proactive action is critical ...
One of the key refrains of national politics recently has been that we need to address, repair, and replace aging infrastructure. Of course, this leads to the core problem of funding as the amount of infrastructure construction and maintenance currently needed in the U.S. is staggering. The federal government recently put off dealing with this growing problem by extending funding for federal highway and public transportation programs for one year ...
A North Carolina court has required Cincinnati Insurance Company to provide business interruption and extra expense coverage to 16 North Carolina restaurants that lost the use of and access to their properties due to COVID-19 civil authority orders (see North State Deli, LLC, et al. v. Cincinnati Insurance Co. et al.) ...
On 25 September 2020 Parliament approved the final draft of the revised Data Protection Act (rev-DPA).(1) The rev-DPA is expected to enter into force in 2022. However, it is subject to a facultative referendum and the corresponding ordinance will be adapted accordingly – thus, the rev-DPA is still a work in progress ...
Although the U.S. Department of Justice (DOJ) reported a slight decrease in settlements with life sciences companies in FY2019 (the most recent year for which data is available),[1] this likely will be a temporary trend. Several significant settlements and investigations in 2020 provide key insights into government enforcement priorities as we look toward 2021 ...
Join us for a special opportunity to hear directly from the CFPB about mortgage servicing in the COVID-19 era. On October 14 from 2:00-3:00 p.m. ET, Bradley hosted a Q&A session with Allison Brown of the CFPB's Office of Supervision Policy to discuss the CFPB’s supervisory expectations as the industry grapples with CARES implementation and other challenges arising from the coronavirus crisis ...
On September 30, 2020 important changes to the Agricultural Land Commission Act, [SBC 2002] Chapter 36 and the associated regulations came into force that may significantly affect the prospects for removal of private land from the Agricultural Land Reserve (“ALR”). These changes are of particular note to private owners of ALR lands slated for future development ...
