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Practice Industry: Crossborder Trade & Investment, Dispute Resolution, Healthcare & Pharmaceuticals
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Hunton Andrews Kurth LLP | August 2015

The federal securities laws require public companies to make and keep detailed and accurate “books, records, and accounts.” One might assume that a securities law relating to books and records covers materials used in the preparation of financial statements. But in practice, the U.S. Securities and Exchange Commission applies a much broader definition that seems to encompass every piece of paper and data in a company’s possession ...

Hunton Andrews Kurth LLP | August 2015

When not conducted carefully, internal investigations cancause more harm than good. Deciding to investigate a suspected problem is onlythe first of several key determinations. The responsible executive must planand execute the investigation deliberately to avoid self-inflicted harm. Anorganization can protect itself—while still conducting an investigation that isconfidential, full and fair—only by carefully thinking about how best touncover the alleged wrongdoing or compliance issues ...

Hunton Andrews Kurth LLP | August 2015

The New England Patriots may play the first quarter of the 2015-16 season without quarterback Tom Brady, as he was suspended for failing to cooperate with an investigation related to footballs deflated below league standards being used in the 2014-15 season AFC championship game with the Indianapolis Colts ...

Haynes and Boone, LLP | August 2015

The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...

Karanovic & Partners | August 2015

When one thinks of resolving disputes in Serbia, the first thing that comes to mind is the long, costly, inefficient dispute before a court, in a dusty court-room in a socialist architecture grey building. Even though these conditions still are reality, Serbia is making efforts in recent years to achieve higher efficiency in resolving disputes through various types of judicial reform including arbitration as one of dispute resolution mechanisms ...

The Competition Commission of India (“CCI”) has revised the Competition Commission of India (Procedure in regard to the transaction of business relating to combinations) Regulations, 2011 (Combination Regulations), making them more forward looking, in keeping with some of the best practices in other jurisdictions. The instant revision is the fourth instance in the four years since the introduction of the merger control regime in India ...

Lavery Lawyers | July 2015

In a decision rendered on April 30, 20151, the Administrative Tribunal of Québec (the "ATQ") upheld a decision of the board of directors of a university hospital centre that refused to renew the status and privileges of a physician who failed to fulfill the obligations associated with the enjoyment of these privileges. Firstly, it should be noted that the applicant's clinical competence was not questioned in this case ...

Following Cuba’s removal from the list of State Sponsors of Terrorism on May 29, 2015, the United States and Cuba took an additional step towards normalizing relations by announcing the reopening of embassies after more than five decades of their closure. The announcement of an agreement to reopen embassies, which was made today, is the first step in converting each country’s present “Interests Section” into formal embassies ...

Carey | June 2015

On June 6th, 2015, Law No. 20,850, which creates the Financial Protection System for Diagnostics and Treatment of High Costs, and pays posthumous tribute to Luis Ricarte Soto Gallegos, has been published. This law creates a financial protection system for diagnostics and high cost treatments which will be defined by the Ministry of Health by means of a Supreme Decree ...

Dykema | June 2015

On June 29, President Obama signed the Trade Preferences and Extension Act of 2015, which significantly increases penalties for the failure to file correct information returns under I.R.C. § 6721 and the failure to furnish statements to payees pursuant to I.R.C. § 6722. The new law increases the penalty from $100 to $250 for each violation of either statute ...

Lavery Lawyers | June 2015

In a decisive victory for the Plaintiffs in class actions against the three Canadian leading tobacco companies1, the Québec Superior Court ordered the Defendants to pay more than 15 billion dollars in moral damages2 and punitive damages. There were more than 253 hearing days3 and 16 years of proceedings. THE ACTIONS In February 2005, Justice Pierre Jasmin authorized two class actions against JTI-Macdonald (JTM), Imperial Tobacco (ITL) and Rothmans, Benson & Hedges (RBH) ...

Asters | June 2015

Restraints of trade - Scope of rules: 1. Are restrictive agreements and practices regulated? If so, what are the substantive provisions and regulatory authority? Restrictive agreements and practices may qualify as anti-competitive concerted practices (that is, practices that resulted or may result in prevention, elimination or restriction of competition). There is a general prohibition of anti-competitive concerted practices, unless an exemption applies (see Question 3) ...

Makarim & Taira S. | April 2015

On 5 January 2015, the Minister of Trade issued Regulation No. 4/M-DAG/PER/1/2015 of 2015 on Provisions to Use a Letter of Credit for Exporting Certain Commodities (“MOT Regulation 4”). One of the goals of MOT Regulation 4 is to provide a clear and verifiable record of prices actually paid by foreign buyers for exported natural resource products ...

Makarim & Taira S. | April 2015

In Indonesia, domestic and international arbitration falls under the Arbitration Law (Law No. 30 of 1999). The Arbitration Law is not based on the UNCITRAL Model Law. Under the Arbitration Law, any award handed down outside the territory of Indonesia (e.g. in Singapore or London) is classifi ed as an international arbitration award ...

Lavery Lawyers | April 2015

In a judgment handed down on January 30, 2015, the Court of Québec held that the failure to respect the prescribed time limits or the violation of a patient’s fundamental rights and freedoms does not lead to the automatic exclusion of a psychiatric examination report concluding that the patient should be confined ...

On April 14, 2015, the White House announced that President Obama intends to remove Cuba from the government’s list of nations that sponsor terrorism. This decision follows a series of important changes to US policies and regulations affecting business and commercial transactions between the United States and Cuba ...

Haynes and Boone, LLP | April 2015

On April 10, 2015, the Texas Medical Board (“TMB”) voted in favor of adopting amendments to the rules governing telemedicine. The revised rules, which will significantly limit the ability to treat patients via telephone and video consultation, take effect June 3, 2015. TMB took its first steps to curb telemedicine in January 2015 by passing an emergency measure that prohibited prescribing drugs without an initial in-person visit ...

Shoosmiths LLP | April 2015

One of the central functions of a contract is to be able to enforce its obligations. Within the EU, under the new Recast Brussels Regulation (the Regulation), it is now easier, quicker and cheaper to enforce EU judgments within England and Wales. The Regulation applies to all proceedings instituted on or after 10 January 2015 within the EU. This article looks at the key changes introduced and key points to be aware of when seeking to enforce ...

On March 19, 2015, the competition regulator in India – the Competition Commission of India (“CCI”), passed an order rejecting charges that Suzuki Motorcycle India (“Suzuki”) had abused its dominant position in the market for manufacturing and sale of two-wheeler vehicles ...

Private sector, investors and experts agree that the Government of El Salvador has to improve the business climate to attract more national and foreign investment that would contribute to increase the Gross Domestic Product and improve in this way the living conditions of the population ...

DFDL | March 2015

Importing foreign wine will now beallowed by all domestic importers, ending a decades-old ban in the country and opening up a potentially profitable investor opportunity in a country ranked one of the top tourism spots for 2015 ...

Shoosmiths LLP | March 2015

On 10 January 2015, new EU rules on jurisdiction and enforcement of judgments in civil and commercial matters came into effect as a result of the Brussels Regulation (recast) (Regulation (EU) 1215/2012) (the recast Regulation). Although the recast Regulation introduces several important changes to the Brussels regime, this article considers the controversial arbitration exclusion to that regime and looks at the likely impact for commercial parties ...

Haynes and Boone, LLP | March 2015

In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...

Haynes and Boone, LLP | March 2015

Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...

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