Last month, CMS issued a proposed rule that would drastically expand the agency’s authority to further its program integrity efforts through the provider and supplier enrollment process. This proposed rule, referred to as CMS-6058-P, (located in the Federal Register at 81 Fed. Reg. 40 ...
Originally filed in October 2014, the long-running and high-stakes battle between two powerhouse companies, Amgen and Sandoz, continues to lay out the ground rules for a growing biosimilar industry. The Federal Circuit’s first decision under the Biologics Price Competition and Innovation Act (BPCIA) involved Zarxio, Sandoz’s Neupogen biosimilar product. Amgen v. Sandoz, 794 F.3d 1347 (Fed Cir. 2015) ...
The government's current plans to increase the UK's wind energy industry are "too late and too weak", the British Wind Energy Association (BWEA) has argued. Under recent proposals put forward by the European Commission, the UK must obtain 40 per cent of all electricity from renewable sources, such as wind and solar power, within the next 12 years ...
The effects of the precipitous decline in oil and gas prices after mid-2014 are well chronicled, but are still unfolding. Although oil prices have risen recently, the current price environment continues to adversely affect a broad range of energy-industry and related-industry businesses, including exploration and production, service and supply, and midstream companies, as well as those that directly or indirectly support or contract with those businesses ...
Purchasing a yacht should be a pleasurable experience given that the craft in question is most likely to be used for the owner’s leisure pursuits. Yachts, however, whether they are second-hand, new, large or small, have one thing in common. They are expensive. However, many purchasers whether they are paying £10,000 or £1,000,000 are sometimes less cautious than perhaps they should be when buying what is in effect a “toy” ...
On May 25, 2011, the en banc Federal Circuit announced its decision in Therasense, Inc. v. Becton, Dickinson & Company regarding the appropriate standards for succeeding with an inequitable conduct defense ...
On 10 March 2022, the Cabinet Office published the long-awaited draft Terms of Reference for the UK COVID-19 Inquiry.1 In this article we consider the implications for businesses impacted by the pandemic and how they may wish to get involved in the Terms’ finalisation. Terms of Reference are critical to a public inquiry as they define its scope and purpose ...
Dear valued clients, colleagues and friends, Bursa Malaysia Berhad (“Bursa Malaysia” or the “Exchange”) announced on 15 August 2022 that it will be launching the Voluntary Carbon Market (“VCM”) exchange by the end of 2022 to enable companies to purchase voluntary carbon credits from climate friendly projects and solutions, to offset their carbon emission footprint and to meet their voluntary climate goals ...
Action: On August 20, 2014, the Bureau of Ocean Energy Management (BOEM) issued an Advance Notice of Proposed Rulemaking (ANPR) on Risk Management, Financial Assurance and Loss Prevention.1 In a news release announcing the ANPR, BOEM described the ANPR as instituting a “dialogue” with industry and others on how to improve its risk management program by “modernizing” its current regulations, which are approximately 20 years old.Comments on the ANPR are due October 20, 2014 ...
On February 17, 2017, the Bureau of Ocean Energy Management (“BOEM”) withdrew its December 2016 orders requiring sole liability properties to provide additional security in the form of supplemental bonds for plugging, abandoning, and decommissioning Outer Continental Shelf (“OCS”) wells, platforms and other facilities ...
Under longstanding regulations governing its risk management program, Bureau of Ocean Energy Management (“BOEM”) may require an offshore oil and gas lessee or operator operating on the Outer Continental Shelf (“OCS”) to provide additional security, over and above standard security requirements, if BOEM determines that the security is necessary to ensure compliance with OCS lease obligations ...
Beginning of Stage 2 of the National Vaccination Plan The Colombian Ministry of Health and Social Protection (Minsiterio de Salud y Protección Social) declared the initiation of stage 2 of the National Vaccination Plan against COVID-19 for the population between 60 and 79 years of age. This does not mean that vaccination for those over 80 years of age will be stopped; these people will continue to be vaccinated without any interruption ...
On May 1, 2020, President Donald Trump issued an Executive Order declaring a national emergency with respect to threats to the U.S. bulk-power system posed by the unrestricted supply of bulk power equipment by persons owned by, controlled by, or subject to the jurisdiction or direction of a foreign adversary, presumably including China, a source for many of the components impacted by the Executive Order ...
A dangerous trap for an unwary insured looking for insurance coverage can be a notice provision. To trigger certain liability insurance policies, the insurer may require that a “claim” be both made against an insured and that the insured then report such claim to its insurer during the time the single insurance policy is in effect. This is what is known as a “claims-made-and-reported” policy ...
By: John Epperson San Francisco’s Board of Supervisors passed an Emergency Ordinance on July 7 entitled “Cleaning and Disease Prevention Standards in Tourist Hotels and Large Commercial Office Buildings” (the “EO”). The EO is expected to be signed by the Mayor and go into effect soon ...
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 ...
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 ...
On June 7, 2021, the Department of Managed Health Care (“DMHC”) issued an All Plan Letter (APL-21-016) to the health care service plans it regulates, announcing that health care service plans must continue to cover certain COVID-19 testing for their enrollees beyond the now-expired DMHC’s emergency regulation[1] (“Emergency Regulation”) ...
San Francisco’s Department of Public Health (“SFDPH”) issued yet-another update to its Shelter-in-Place Order, C19-07, on September 14, 2020 (now up to version “i”). This order has been frequently modified to reflect changes in other state and local directives, as more is learned about the disease and as more businesses are allowed to re-open ...
U.S. Trademark laws are based on the premise that rights in a trademark exist so long as the mark is continuously used in interstate commerce. Once you cease use of the mark without an intention of resuming such use, the mark may be subject to cancellation or abandonment by a third party ...
September 16, 2021 By: John Epperson The COVID-19 pandemic will likely to be a concern and challenge for employers for longer than anyone had hoped or anticipated. As businesses adjust to what seems to be a “new normal” it is worth a reminder that COVID-19 infection can be a recordable illness on an employer’s Occupational Safety & Health Administration (“OSHA”) 300 Injury and Illness Log. OSHA’s recording criteria under 29 CFR 1904 ...
Cal-OSHA’s COVID-19 regulation remains in effect after the trial court rejected a motion for a preliminary injunction filed by a coalition of employers. This included challenges to: (1) compensation for employees excluded from work; (2) mandated testing; and (3) health and safety requirements for employer-provided housing and transportation. Therefore, employers must continue to abide by the requirements of the emergency regulation ...
As California continues to move through Stage 2 of its Resilience Roadmap, “Lower-risk workplaces,” where retail (curbside and delivery only), related logistics and manufacturing, office workplaces, limited personal services, outdoor museums, childcare, and essential businesses can now open with modifications, California employers should continue to be vigilant in assessing and complying with up to date health and safety guidance from the Occupational Safety and Health Admini
In addition to proceeds from the U.S. Small Business Administration’s (“SBA”) Payment Protection Program and the Centers for Medicare & Medicaid Services’ (“CMS”) Accelerated and Advance Payment Program, the U.S. Department of Health & Human Services (“HHS”) recently deposited $80 billion into health care providers’ bank accounts as part of its Provider Relief Fund ...
