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Bankruptcy Moratorium Expiration: The Supreme Court of the Russian Federation Clarifies a Number of Key Issues
ALRUD Law Firm, January 2021

On January 7th 2021, the bankruptcy moratorium, which had been in effect since April last year, expired. The main conditions of the bankruptcy moratorium were described earlier in details: in newsletters “Moratorium on bankruptcy proceedings”and 'Russian bankruptcy moratorium extended until January, 2021”...

HHS Freezes Rule Affecting Community Health Center’s 340B Drug Discounts
Dinsmore & Shohl LLP, January 2021

The Biden administration implemented a regulatory rule freeze affecting all federal agency rules that had not gone into effect as of Jan. 20, 2021.  At its core, the regulatory rule freeze requires all pending final rules to be delayed at least 60 days in order for the Biden administration to review and opine on the necessity and scope of affected rules. During this delay period, the administration may review, revise, and possibly rescind federal administrative rules...

California Proposes Significant Change to Limit Use of Short-Form Proposition 65 Warning For Consumer Products
Hanson Bridgett LLP, January 2021

Article PDFJust when businesses thought they had figured out their Proposition 65 compliance strategies, the State of California, through the Office of Environmental Health Hazard Assessment (OEHHA), has proposed a substantial change that will drastically limit the use of the short-form safe harbor warning first authorized in 2018...

International Air Travelers Entering the United States Must Have a Negative COVID-19 Test
Dinsmore & Shohl LLP, January 2021

Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline...

Winding-Up a Company: It Now Takes More to Wind-Up a Company, in the Same Amount of Time
Shearn Delamore & Co., January 2021

BackgroundSection 466(1)(a) of the Companies Act 2016 (“CA 2016”) provides that a company is deemed unable to pay its debts if it is indebted in a sum exceeding an amount prescribed and neglects to pay the sums stipulated in the notice of demand within 21 days of being served with the said notice.Through the issuance of the Prescription of Amount of Indebtedness of Company published on 26 January 2017 (“2017 Threshold Order”), this amount was fixed at RM10,000...

CDC to Require Negative COVID Tests for All International Air Passengers
Dykema, January 2021

The United States’ Centers for Disease Control and Prevention (CDC) has issued an order that will take effect on January 26, 2021, requiring all arriving international airline passengers to provide proof of a negative COVID test taken within three days of the flight’s foreign departure. For those who have had it, the CDC will require proof of recovery...

Bulletin Real Time: Latest News
Brigard Urrutia, January 2021

Read the latest news 1. Air travelers arriving to Colombia must provide evidence of a negative PCR test to be allowed entry On December 31st, 2020, the Ministry of Health and Social Protection (Ministerio de Salud y Protección Social) modified the biosecurity protocol for the international air transportation, adding the following measures: Airport operators must prohibit the consumption of food and beverages in immigration or emigration areas...

Is the COVID-19 Vaccination in a Child’s Best Interest?
Shoosmiths LLP, January 2021

If parents cannot agree whether their children should be vaccinated, they can make an application under Section 8 of the Children Act 1989 to ask a judge to determine the issue. In M v H (Private Law Vaccination) [2020],  the mother objected to the parties' two children aged six-years-old and four-years-old  being given routine childhood vaccines in accordance with the NHS vaccination schedule...

A Proxy Season and Annual Report Guide to 2021
Dinsmore & Shohl LLP, January 2021

This is a summary of the Annual Report. Click here to access the full guide. The 2020 proxy season shareholder proposals were already submitted before the COVID-19 shadow loomed large over the season; however, such shadow likely impacted how shareholders voted on the proposals themselves, impacted business throughout 2020, and continues to jolt 2021 and the forthcoming 2021 proxy season...

New Federal Exceptions Favor Value-Based Care
Dinsmore & Shohl LLP, January 2021

On Nov. 20, 2020, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) issued two final rules, which implement changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Final Rule and the CMS Final Rule, collectively the Final Rules)...

Bitesize: Freeports – Joint Ventures
Shoosmiths LLP, January 2021

To boost the economy post-Brexit the government is committed to establishing up to 10 freeports across the UK and published a bidding prospectus at the end of last year. In our bitesize articles we provide a high-level overview of some of the key considerations if you are planning to participate in a bid and/or are considering the potential benefits of locating (or relocating) all or part of your business within a freeport (when established)...

Capacity and Lockdown Part 3.0
Shoosmiths LLP, January 2021

The Court of Protection is a specialist Court, focussing solely on supporting vulnerable individuals. This past year has acutely highlighted the needs of those most vulnerable in our society and their dependency on others to help manage their affairs. The Court has had to adjust its practices in order to ensure that help and solutions are found for those lacking capacity with minimal delay...

State of Ohio Board of Pharmacy Adopts Resolution Regarding Responsible Person Requirements for Licensure of Terminal Distributor and Dangerous Drugs License
Dinsmore & Shohl LLP, January 2021

The State of Ohio Board of Pharmacy (OBP) is required to adopt a resolution specifying the required types of credentials for the responsible person of each business type of (i) terminal distributors of dangerous drugs and (ii) distributor of dangerous drugs. Only individuals who meet the credentials specified may be the responsible person for that type of business. On Jan...

Power to the Contract
TSMP Law Corporation, January 2021

A recent court of appeal decision has definitively clarified the test for assessing the enforceability of liquidated damages clauses in Singapore. Contracting parties intending to incorporate liquidated damages clauses must be mindful of the type of damages that may be recovered in the event of default, especially when exercising a contractual right to terminate the contract...

The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?
Verrill, January 2021

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) published a final rule revising regulations to the Stark Law. The Stark Final Rule adds, modifies and clarifies key definitions and exceptions...

FTC Settles Enforcement Actions Against CBD Companies: The Writing Was On The Wall
Dinsmore & Shohl LLP, January 2021

For several years, pursuant to the Food Drug and Cosmetic Act and Federal Trade Commission Act,[i]  the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued joint warning letters to CBD companies alleging labeling claims they made are false or misleading. According to the agencies, the claims being made by these CBD companies include assertions that their CBD products will treat or cure serious health conditions...

Enhanced Rights Issue Framework: Temporary Relief Measures to Facilitate Fund Raising by Listed Issuers.
Shearn Delamore & Co., January 2021

In this article, Gan Shao Qi discusses some of the recent measures announced to facilitate fund raising by listed issuers through a rights issue in Malaysia to assist companies and businesses that require access to immediate funding due to Covid-19...

The BCA Suspects Caudalie of Imposing Minimum Resale Prices on its Distributors
ALTIUS/Tiberghien, January 2021

Over the last 4 years, the Belgian Competition Authority (“BCA”) has increasingly scrutinised anticompetitive restraints in vertical agreements and assessed these restraints under Article IV.1 of the Belgian Code of Economic Law and Article 101 TFEU...

Three Things in Healthcare - January 5, 2021
Hunton Andrews Kurth LLP, January 2021

Coming to Grips with Hospital Price Transparency – DC Circuit Rejects American Hospital Association’s Effort to Invalidate Price Transparency Requirements Rule Since 2010, Section 2718(e) of the Public Health Service Act has required hospitals to establish and publish annually “a list of the hospital’s standard charges for items and services provided by the hospital...

Improper CBD Product Marketing Lands in FDA’s Crosshairs
Dinsmore & Shohl LLP, January 2021

On Dec. 22, 2020, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.[i] CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19...

Stark Law: Clarification of Key Terms
Dinsmore & Shohl LLP, January 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 Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules) will become effective...

HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies
Verrill, January 2021

As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered outpatient drugs purchased by providers at 340B discounted rates to contract pharmacies, so that contract pharmacies can dispense such drugs to patients on behalf of providers. See HHS General Counsel Advisory Opinion, dated December 30, 2020...

2021: In Which We Rise from the Ashes of the Pandemic - Goodbye, Annus Horribilis?
TSMP Law Corporation, January 2021

If anyone had told you that 2020 would be a year in which you are virtually guaranteed a lie-flat bed in economy class, businesses instructed employees not to come into the office, and budget supermarket Sheng Siong’s shares outperformed bank blue chip DBS’s, you would have sent the chap to have his head checked.But as the new coronavirus spread worldwide, the ensuing Covid-19 pandemic forced billions into lockdown...

San Francisco Imposes Quarantine on Travelers and Commuters from Outside the Bay Area with Two Exceptions for Construction Workers
Hanson Bridgett LLP, January 2021

The City and County of San Francisco (SF) issued a COVID-19 surge-related travel and quarantine order (Quarantine Order) on Dec. 16, 2020, and an updated Shelter-In-Place Order (SIP Order) on December 9 (updated Dec. 30, 2020). Under those orders, every person who enters SF after having been outside the Bay Area within the last ten days must quarantine for 240 hours from the time of arrival in SF. However, two exceptions apply to those working on construction projects in SF...

HHS Proposed HIPAA Changes: 7 Things to Know
Buchalter, January 2021

On December 10, 2020, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule to support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry...

 

 

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