The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
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.) ...
How retailers can harness technology to beat e-commerce at its own game. “It's official: Singapore malls are dead, as occupancy reaches its lowest level in 10 years,” screams one headline. “At some suburban malls, retailers confront the sound of silence,” another chimes in. As e-commerce takes hold, shoppers are eschewing brick and mortar in favour of the convenience of point and click ...
Are bidders required to partner with a Taiwan company to participate in the bidding process? Foreign companies may participate in the bidding process on their own, so long as they meet the bidding qualifications. Most public engineering projects permit either bidding by a single company or by a joint bid. So long as a company is able to meet the qualifications for the procurement project, it may submit a bid on its own ...
After getting the knowledge of GPA Model and PPP Model, the bidders need to know how to make preparation during the pre-bid stage. Following are the responses to some most frequently asked questions regarding bidding qualifications, based on which the foreign bidders can make its preparation plan ...
Two significant events this week raised eyebrows in the lucrative world of live sports broadcasting. Firstly, Facebook agreed an exclusive deal to show La Liga to users in Asian territories including India, Bangladesh, Sri Lanka and Pakistan. It will live stream all 380 matches this season for free to its 348 million users in the region. The move fits with Facebook's ambition to grow use of its social networking platform outside markets that have reached saturation ...
April 12, 2024 By: Charles Whiteman and Daniel C. Silva Friendship only goes so far, at least in the case of the Los Angeles Dodgers’ baseball superstar Shohei Ohtani (“Ohtani”), and his former interpreter and de facto personal manger, Ippei Mizuhara (“Mizuhara”). On April 11, 2024, the U.S ...
Content Legal and enforcement framework Definitions Virtual currencies market Crossover with banking Technology Data security and cybersecurity Financial crime Consumer protection Competition Taxation Trends and predictions Tips and traps Legal and enforcement framework In broad terms, which legislative and regulatory provisions govern virtual currencies in your jurisdiction? Bermuda has a digital asset sector with a specific legal and regulatory regime that governs both the i
An interesting news update has recently come up in the media, as the Serbian roads company "Putevi Srbije", and the Ministry of Construction, Transport, and Infrastructure – together with the representatives of the relevant institutions in Romania – announced that a contract on implementing a cross border project of building the Belgrade-Timisoara highway is due to be signed in the next two weeks ...
For the first time, the CJEU has been askedto clarifythetemporal applicabilityofthe right to“appropriate and proportionate remuneration” laid down inArticle 18 ofDirective (EU) 2019/790 on copyright and related rights in the Digital Single Market(“DSMDirective”) ...
On 22 September 2023, the Royal Decree of 13 September 2023 establishing specific rules on the public procurement of biological medicinal products was published in the Belgian State Gazette (“Royal Decree”) ...
The Supreme Court (“Hof van Cassatie/Court of Cassation”) overruled on 26 May 2023 a decision that determined that Article 1722 (old) Civil Code (a partial or total “destruction” of the leased premises) does not apply for the tenant that can not operate its premises due to the measures taken by the Belgian Government in order to prevent the spread of the COVID-19 pandemic, because there was only a temporary impossibility and thus only a temporary loss of enjoyment ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
Surfside Collapse – what we know so far: On Thursday, June 24, 2021, at approximately 1:25 a.m., Champlain Towers South, a twelve-story beachfront condominium in the Miami suburb of Surfside, Florida, partially collapsed. The collapse was reported as the third deadliest structural engineering failure in United States history. Ninety-eight people were confirmed dead, only four people were rescued from the rubble ...
WHAT'S NEW COVID-19 Business Strategies Hub Since the news first broke about the COVID-19 pandemic and its impact on the global economy, Dinsmore has worked diligently to create the COVID-19 Business Strategies Hub. The Hub features attorney insights and complementary webinars to help you prepare and respond to legal, regulatory, and commercial implications related to the crisis ...
Originally published in DRI - For the Defense. By Hakim Bouadi, Stephanie U. Eaton, Matthew W. Georgitis, and Robert A. Plichta Bringing an engineer and an architect onto the legal team as soon as a building catastrophe happens has more than just legal benefits ...
Key Points: Bay Area counties issued new Shelter Orders on April 29, 2020 allowing all construction to resume. The new Shelter Orders include detailed Construction Safety Protocols that construction jobsites must comply with. There is one Construction Safety Protocol for “small” construction projects, and a more rigorous Construction Safety Protocol for “large” construction projects ...
On March 31, 2020, Alameda, Contra Costa, Marin, San Francisco, San Mateo, and Santa Clara counties plus the City of Berkeley issued new Shelter-in-Place orders, further restricting construction and extending Shelter-in-Place restrictions until May 3, 2020. Under the new orders, most construction, including residential and commercial, is now prohibited. Healthcare, low income housing, specially designated public works projects, shelters, and temporary housing projects may continue ...
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 ...
All shops, bars, restaurants and leisure centres will be closed at least until 6 April 2020. Only grocery stores, pet food stores, pharmacies, banks, post offices and book shops will remain open until that date insofar as the social distancing (at least 1 meter distance) can be guaranteed. Night shops can stay open until 10 pm insofar as social distancing is applied. Food stalls on markets are only allowed insofar as considered essential ...
Bare trusts are increasingly being used when investors acquire investment properties as they provide a number of significant advantages. Anyone considering purchasing an apartment building should fully examine the potential use of a bare trust arrangement. What is a bare trust? A bare trust is a legal structure that facilitates the division of the beneficial and legal ownership ...
When I was a young lawyer working for the Norwegian Competition Authority, a complaint was received that gave rise to some amusement among the staff at the authority. The complainant argued that the Norwegian football club Viking FK’s signing of the half-decent footballer Ragnvald Soma from rivalling club SK Brann constituted an infringement of Norwegian competition law. Nowadays, competition law in football is no longer a laughing matter ...
