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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Haynes and Boone, LLP | March 2020

With the coronavirus outbreak, attention has been focused on the Defense Production Act of 1950 (“DPA”)[1], a statute dating back to the time of the Korean War, which authorizes the President in times of national emergency to: Make direct purchases and purchase commitments of critical supplies and services; Interrupt the normal flow of goods, even when under contract, by requiring U.S ...

Shoosmiths LLP | September 2023

Decentralized Finance (DeFi) represents an emerging financial model that utilises distributed ledger technologies to provide functions like borrowing, investing, or trading digital assets, all without the need for conventional centralised intermediaries. Here is a quick update with what is occurring on the international stage ...

Shoosmiths LLP | March 2023

In this article we follow up on some current issues in the defined contribution (DC) sphere. In its corporate plan for 2022 to 2024, the Pensions Regulator (TPR) reasserted its commitment to defined contribution savers getting the pensions that they are entitled ...

Dinsmore & Shohl LLP | March 2023

Prepare for another big shift in health care operations. On January 30, 2023, President Joe Biden announced he would not extend the COVID-19 Public Health Emergency (PHE) beyond its current expiration date of May 11. The PHE was declared by former President Donald Trump in March of 2020 as COVID-19 began to spread around the nation. The waivers and other regulatory changes instituted in its wake have impacted nearly every facet of health care services ...

FISCHER (FBC & Co.) | August 2018

The Israeli Securities Law was amended (Amendment No. 63) with a goal of turning the Tel-Aviv Stock Exchange (TASE) into a more competitive, efficient and profitable stock exchange, by outlining an ownership structure change of the TASE. The ownership structure change allows private investors, in addition to institutional investors, to acquire means of control over the TASE ...

Plesner | June 2018

Earlier this year the Danish parliament adopted a new Act to establish a national genome center that will develop and run a nationwide information infrastructure for personalised medicines. The National Genome Center will provide a common infrastructure with capacity for genome sequencing and a national genome data base. Persons within the healthcare sector and patients will receive information on the use of patient treatment ...

Dinsmore & Shohl LLP | October 2019

Elite Dental Associates, Dallas (“Elite”) has agreed to pay $10,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services and to adopt a corrective action plan to settle potential violations of the HIPAA Privacy Rule[1]. According to OCR, Elite is a privately owned dental practice in Dallas, Texas, providing general, implant, and cosmetic dentistry ...

Recently, modifications announced by the Department of Health and Human Services (“HHS”) to 42 C.F.R. Part 2 (“Part 2”) rules governing Confidentiality of Substance Use Disorder (“SUD”) Patient Records went into effect. This is a major rule change for Part 2 providers and the enhanced penalties and enforcement measures make compliance with the new rules essential for any Part 2 provider ...

Waller | December 2009

The U.S. Department of Justice recently announced an enforcement initiative targeting the pharmaceutical industry for investigations and prosecutions under the Foreign Corrupt Practices Act (FCPA).  The FCPA prohibits improper payments to foreign government officials for the purpose of obtaining or retaining business and mandates that companies that issue securities take affirmative measures to prevent such payments ...

Dinsmore & Shohl LLP | March 2018

Last week, United States Attorney General Sessions announced the creation of the Department of Justice Prescription Interdiction & Litigation (PIL) Task Force to combat the prescription opioid crisis.  According to the Department of Justice (Justice), the PIL Task Force will rely on “all available criminal and civil enforcement tools” to hold those at “at every level of the [opioid] distribution system” accountable for unlawful conduct ...

Haynes and Boone, LLP | October 2011

Under final rules issued by the Centers for Medicare and Medicaid Services (CMS), Accountable Care Organizations (ACOs) will continue to face large start-up costs and uncertain savings, despite a decreased regulatory scheme and increased financial incentives ...

Brigard Urrutia | November 2017

Latin America’s current economic growth levels are among the world’s highest, and the region is preparing its regulations to meet new economic challenges. As such, the fostering of foreign trade and foreign direct investment (FDI) is important to increase GDP growth, create job opportunities, and improve logistics and production ...

AELEX | December 2020

Over the past few weeks, the Central Bank of Nigeria (“CBN”) has issued circulars amending and clarifying the procedure for receipt of diaspora remittances (“the Circulars”) in Nigeria ...

ALRUD Law Firm | July 2020

As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.Start of mandatory digital labellingFrom 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system ...

Mamo TCV Advocates | January 2023

  Matters of cross-border company mobility are addressed at European Union level by means of Directive (EU) 2017/1132 (the “2017 Directive”) which provides for cross-border mergers and domestic divisions of public limited liability companies ...

Shepherd and Wedderburn LLP | February 2006

In April 2005 a new Disability Discrimination Act was passed by Westminster. The Act extends existing non-discrimination legislation, primarily the Disability Discrimination Act 1995. While some provisions of the Act came into force in December 2005, many others will be coming into force over the course of 2006. It is essential that businesses are aware of their new responsibilities under the Act and prepare for its implementation ...

Shoosmiths LLP | November 2022

How can an employment disciplinary investigation findings determine fitness and propriety? Senior Managers & Certification Regime (SM&CR) firms are under a duty to consider fitness and propriety on an ongoing basis ...

Dinsmore & Shohl LLP | March 2020

In an effort to streamline the provision of COVID-19 patients’ Protected Health Information (PHI) to public health authorities, the United States Department of Health and Human Services Office for Civil Rights (OCR) recently published practical guidance explaining the methods by which Health Insurance Portability and Accountability Act (HIPAA) Covered Entities may disclose COVID-19 patient PHI to law enforcement, first responders, and public health authorities ...

ALRUD Law Firm | January 2019

On June 12, 2018, amendments to the Federal law No. 57-FZ, dated April 29, 2008 “On Foreign Investments into Business Entities of Strategic Importance for the Country’s Security, Protection and Defense Support” (“Strategic Investments Law”) came into force ...

Lavery Lawyers | October 2014

On October 3, 2014, the Supreme Court of Canada, by a majority decision of 5 to 4,1 confirmed that a disposition ordering the treatment of an accused who is found unfit to stand trial requires the prior consent of the designated hospital to all the terms of the disposition order, inclusive of the date on which the treatment is to begin ...

PLMJ | April 2006

The commercial distribution of goods and services developed with the dynamics between sophisticated global markets, where the European Internal Market is integrated, with traditional markets of a local character or national dimension. The type of contract adopted by the producers or importer companies in order for their products or services to reach, through the commercial intermediaries, the final users – consumers or not – i. e ...

PLMJ | April 2006

A distribution franchise agreement allows a producer of goods or services (the “Franchisor”) to transfer to another entity (the “Franchisee”), in return of a fee, the commercialisation of such products under the Franchisor’s trade mark(s) and distinctive signs, in conformity with its uniform business method and upon the provision, by the Franchisor to the Franchisee, of technical know how and regular assistance ...

Dinsmore & Shohl LLP | December 2022

The SEC Division of Examinations issued a Risk Alert on December 5, 2022 detailing observations from examinations of investment advisers and broker-dealers related to compliance with Regulation S-ID ...

Dinsmore & Shohl LLP | April 2023

The SEC Division of Examinations (the “Division”) issued a Risk Alert on March 27, 2023 detailing observations from examinations of newly-registered investment advisers.  The Risk Alert provides information about the typical focus areas reviewed during examinations of newly-registered investment advisers. It also provides observations regarding compliance policies and procedures, disclosures and marketing practices ...

On March 30, 2022 the Division of Examinations of the United States Securities & Exchange Commission published the 2022 Examination Priorities. As in other years, the 2022 Examination Priorities document provides certain data regarding the scope of the examination program and the growth of the investment adviser community ...

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