As concern over cybersecurity continues to grow,[1] defense contractors have been waiting for the Department of Defense (DoD) to roll out its Cybersecurity Maturity Model Certification (CMMC) program. That rollout has occurred, with DoD’s recently published interim rule Assessing Contractor Implementation of Cybersecurity Requirements (DFARS Case 2019-D041)[2] (“Interim Rule”), effective Nov. 30, 2020, and providing for a five-year phase-in of CMMC ...
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 ...
The Court of Justice of the European Union delivers judgments regarding the concept of “communication to the public” faster than legal scholars can read and dissect them. While we are eagerly awaiting the Court’s analysis of different types of hyperlinking, it has taken less than two months to follow Advocate General Hogan’s opinion regarding the emailing of evidence containing copyrighted works to a court in legal proceedings ...
On November 5, 2020, in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.” Slip op. at 3 ...
The United States Trademark Office formally announced it will raise the vast majority of its trademark filings fees and implement some new fees as of Jan. 1, 2021. These higher costs will impact every aspect of trademark prosecution, including appeal, cancellation and opposition proceedings before the Trademark Trial and Appeal Board. Trademark owners would be wise to take a look at their upcoming deadlines and potentially take action on them before the end of the year ...
This article has been published in PLI Chronicle. The market for consumer products derived from cannabis and its components, including cannabidiol (CBD), is exploding. U.S. sales of CBD products is expected to exceed $20 billion by 2024, up from just $1.9 billion in 2018. TheCBD market is expected to develop across diverse industries such as cosmetics and skin care, health products, food and beverage, pet products, and pharmaceuticals ...
On Nov. 9, 2020 the SEC’s Office of Compliance Inspections and Examinations (“OCIE”) issued a risk alert detailing its series of examinations of investment advisers operating from numerous branch offices and with operations geographically disbursed from the adviser’s main office. This examination initiative focused on the compliance and supervisory practices relating to advisory personnel working within the advisers’ branch offices ...
The new issue of Legal Insight magazine includes a timely article by Anastasia Kayukova, Senior Associate at ALRUD Law Firm, and Anastasia Sidorenko, Junior Associate at ALRUD Law Firm. It is dedicated to the difficulties of determining the criteria, by which the FAS of Russia (Federal Antimonopoly Service) assesses the need to approve transactions related to the acquisition of “de facto” control rights ...
The Government proposes to consult the Panel of Financial Affairs of the Legislative Council on the introduction of a statutory corporate rescue procedure and insolvent trading provisions to the Legislative Council in the first quarter of 2021. The Companies (Corporate Rescue) Bill was originally introduced in 2000, but was never enacted and has since lapsed ...
The Copyright Office of the Department for Promotion of Industry and Internal Trade (DPIIT) has invited comments and suggestions to amend the Copyright Act before November 30, 2020. Mid last year, the DPIIT proposed a set of amendments to the Indian Copyright Rules. While these amendments sought to increase transparency and provide clarity for right holders, many other essential modifications were overlooked ...
On Nov. 3, 2020, California voters approved Proposition 24, marking a significant shift in the U.S. privacy landscape. Proposition 24 enacted the California Privacy Rights Act of 2020 (CPRA),[1] a major expansion of the existing California Consumer Privacy Act (CCPA), which many businesses continue to grapple with since becoming effective in January 2020. Most notably, the CPRA establishes a stand-alone privacy regulator, the first U.S. state to do so ...
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 ...
The Government of India has been very active in putting in place the necessary framework to implement the objectives of the ‘Atmanirbhar Bharat Abhiyan’. The ‘Atmanirbhar Bharat Abhiyan’ or a program of self-reliance announced by the Government of India intends to focus on the five key pillars of economy, infrastructure, system, vibrant demography, and demand ...
What will UK data protection look like after Brexit 2.0 on 31 December 2020? Regime 1: the 'UK GDPR': the UK's new bespoke version together with the Data Protection Act 2018 The UK GDPR will be the UK data protection regime based on the 'EU GDPR' (see below) ...
Under the Medicare Secondary Payer Act (MSPA), a Medicare Secondary Payer is the entity which has an obligation to pay medical expenses before Medicare. In the face of rising costs, legislation was passed in 1980 making Medicare a secondary payer to various primary plans in order to shift medical expenses to those Medicare believed should be the primary source of payment ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
British Government aims to forbid import of commodities from deforested areas as a consequence of international discussions focused on ESG. In 2019, the British Government hired the independent consultancy 'Global Resource Initiative' ("GRI") to evaluate actions to ensure a more sustainable economy for the United Kingdom ...
While public attention focused on the federal and state elections, Michigan voters made an important decision—they adopted Proposal 20-2, which amended Michigan’s Constitution to extend its protection from unreasonable searches and seizures to electronic data and communications ...
The Sharjah Court of Appeal recently declined to apply the principle of separability of an arbitration clause, on the basis that the underlying agreement (i.e. in which the arbitration clause was contained) was not defective or argued to be invalid by the appellant. This judgment has potentially significant implications for parties who intend to rely on an agreement which contains an arbitration clause to assert claims in court ...
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 ...
