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Hunton Andrews Kurth LLP | August 2013

BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...

There is no centralised data available on M&A in the Philippines. However, based on general investment data compiled by investment promotion agencies (such as the Board of Investments (BOI) of the Philippines) and the Bangko Sentral ng Pilipinas (BSP), total approved foreign direct investment (FDI) for 2012 reached 289.1 billion Philippine pesos, which surpassed the previous year’s record level of 258.2 billion Philippine pesos by 12 per cent ...

The ICSA has published new guidance on terms of reference for audit, remuneration, nomination, risk and executive committees, as well as new guidance on matters reserved for the board. The new guidance notes have been revised to reflect the updated editions of the UK Corporate Governance Code (“Code”) and FRC Guidance on Audit Committees published in September 2012 and which apply to all companies with a premium listing with reporting periods beginning on or after 1 October 2012 ...

The ABI has published a report on improving corporate governance and shareholder engagement. The report is a critical evaluation of the roles and responsibilities of the main elements of corporate governance, including: • The role of the non-executive in providing constructive challenge. • How institutional investors hold companies to account. • The relationships between, and responsibilities of, asset managers and asset owners ...

ENS | July 2013

Pursuant to much speculation, the Common Market for Eastern and Southern Africa’s (“COMESA”) Competition Commission (the “Commission”) become operative on 14 January 2013 ...

PLMJ | July 2013

On the 19th of July, CMVM Regulation no. 4/2013 on the corporate governance of the issuers of shares admitted to trading in Portugal (“Issuers”), and a new version of the CMVM  Corporate Governance Code amending the code in effect since 2010 (“2013 Corporate Governance Code”), were published. Although the aforementioned CMVM Regulation no ...

PLMJ | July 2013

Decree-Law 2/2005 of 27 December, which approved the Mozambican Commercial Code, makes it possible for Mozambican or foreign individuals or clients to set up business in Mozambique in one of six different ways: (i) general partnership (Sociedade em Nome Colectivo); (ii) limited partnership (Sociedade em Comandita); (iii) capital and industry partnership (Sociedade de Capital e Indústria); (iv) quota company (Sociedade por Quotas); (v) single person quota company (Sociedade Unipessoal por Quotas)

Haynes and Boone, LLP | July 2013

In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...

The Pensions Regulator has issued revised codes ofpractice and guidance on reporting the late payment of contributions to ensure a system of effective monitoring of contributions in money purchase work-based and personal pension schemes. The revised codes, which are designed to support auto-enrolment, are expected to come into force this autumn ...

Lavery Lawyers | July 2013

Although non-compliance with the Consumer Protection Act (the “CPA”) is generally sanctioned by the nullity of the CPA non-compliant clauses, or of the contract in its entirety, in cases involving written notices of forfeiture of the benefit of the term, the courts have sometimes decided to maintain the validity of the non-compliant notices if they were not prejudicial to the consumer’s rights. The following two judgment support this view ...

Lavery Lawyers | July 2013

In September 2012, we reported that the Supreme Court of British Columbia had rendered a judgment1 confirming that a corporate policy imposing an advance nomination process for a shareholders’ meeting was reasonable and did not infringe the shareholders' rights relating to the election of the corporation's directors (“Advance Notice Policy”) ...

Makarim & Taira S. | July 2013

Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...

Makarim & Taira S. | July 2013

The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...

Makarim & Taira S. | July 2013

The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...

Makarim & Taira S. | July 2013

On 12 April 2013, the Indonesian Capital Investment Coordinating Body (BKPM) issued a new Regulation of the Head of the BKPM No. 5 of 2013 on the Guidelines and Procedures for Permit and Non-Permit Capital Investment (“Reg ...

Veirano Advogados | July 2013

The passion Brazilians have for football is nothing new. As children, we learn the game and argue over the rules, which are often anything but black and white and, on occasion, are difficult to apply. That’s true even for referees, who, well into the 21st century, are still barred from employing the full array of technologies available to make their work easier. In contrast to other sports, the rules governing football evolve very slowly ...

An expansion strategy doesn’t always need to be M&A driven. Hunton & Williams LLP partners Robert Acosta-Lewis  and Susan Failla make the case for strategic alliances.  When considering expanding into emerging markets, companies often look to traditional M&A opportunities or explore possible distribution or sales representation relationships.  While both of these avenues may offer potential advantages, they also carry risks and limitations ...

Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...

ENS | July 2013

Over the last decade six of the world’s ten fastest-growing economies have been in sub-Saharan Africa. Many predict that over the next decade Africa is likely to emerge as the fastest growing economic region, assuming this mantel from Asia ...

ENS | July 2013

Myriad Genetics is known as a leader in the market for diagnostic testing of BRCA1 and BRCA2 gene mutations that have been linked to breast and ovarian cancer.  These same diagnostic tests were recently in the celebrity press, as Angelina Jolie announced she had been tested positive for the mutations, resulting in her electing to have a preventative double mastectomy ...

ENS | July 2013

The issue of Adwords has become increasingly important in trade mark law.  When you buy a word from Google as an Adword, this has the effect that whenever anyone enters that word as a search term, your pop-up advert will appear on the screen together with the so-called ‘natural results’.  You can buy generic words as Adwords, but you can also buy words that happen to be trade marks ...

Haynes and Boone, LLP | July 2013

Governor Perry recently signed four bills into law designed to combat Medicaid fraud, waste, and abuse. The bills are a mixed bag of enhanced enforcement capabilities for the state and a few new protections for healthcare providers. Most notably, the legislature made several changes to the Texas Medicaid Fraud Prevention Act (TMFPA), bringing the statute more in line with the federal False Claims Act. Changes to the Medicaid Fraud Laws On the enforcement side, S.B ...

A&L Goodbody LLP | July 2013

On 26 June 2013, a new Commission Regulation on what telecommunications operators (Telcos) and Internet Service Providers (ISPs) should do if their customers' personal data is lost, stolen or otherwise compromised, was published in the Official Journal of the European Union. The purpose of the new rules is to ensure businesses, operating in more than one EU country, can take a pan-EU approach in the event of a data breach ...

Haynes and Boone, LLP | July 2013

Recently, the United States Supreme Court issued its decision in American Express Co. v. Italian Colors Restaurant, a third opinion in what is now a trilogy of cases upholding the validity of class action waiver clauses in contracts containing arbitration agreements ...

Haynes and Boone, LLP | July 2013

The Federal Trade Commission (FTC) finalized amendments to formally adopt a framework regarding the voluntary withdrawal of Hart Scott Rodino (HSR) premerger notification filings and submission without an additional filing fee to allow additional time for enforcement agency review of transactions during the initial HSR waiting period ...

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