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Haynes and Boone, LLP | March 2012

On Monday, March 26, 2012, the United States Supreme Court issued a decision in Credit Suisse Securities (USA) LLC v. Simmonds. The Court held that an alleged failure by a corporate insider to file a short-swing profit disclosure under Section 16(a) of the Securities Exchange Act of 1934 does not indefinitely toll the two-year statute of limitations on another party’s claim for recovery of such profits under Section 16(b) ...

PLMJ | March 2012

Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...

Haynes and Boone, LLP | March 2012

In a decision issued this week, Roland v. Green, -- F.3d --, 2012 WL 898557 (5th Cir. Mar. 19, 2012), the U.S. Court of Appeals for the Fifth Circuit addressed an issue of first impression—the scope of the preclusion provision of the Securities Litigation Uniform Standards Act (“SLUSA”). Recognizing the current split among circuits, the court adopted the “tangentially related” test ...

Lavery Lawyers | March 2012

The Powers Of CSST Inspectors ConfidentialityAgreements:The Importance Of Protecting Your Secrets; Your First Financial Institution. Various statutes impose obligations on employers to take the necessary measures to protect the health and safety of workers, including An Act respecting Occupational health and safety (R.S.Q., c. S‑2.1) (hereinafter referred to as the “AROHS”) ...

Lavery Lawyers | March 2012

Class Action and Consumer Law: The Court of Appeal Excludes Non-Consumers from the Approved Class in an Authorized Class Action  CONSUMER PROTECTION LAW AND THE CONSUMER PROTECTION ACT (“CPA”) APPLY FIRST AND FOREMOST TO ECONOMIC ACTIVITIES IN THE RETAIL SECTOR. EXPENDITURES ASSOCIATED WITH THIS SECTOR REPRESENT MORE THAN SIXTY-FIVE PERCENT OF ALL EXPENDITURES IN THE PROVINCE. IT IS ALSO AN AREA OF THE LAW WHICH FREQUENTLY COMES BEFORE THE COURTS ...

Haynes and Boone, LLP | March 2012

You are the general counsel of a public company and expect M&A activity to increase in the United States during 2012. Do you know if your company looks like a good target to potential acquirors? It is important to understand whether you could be a target before getting that first overture from an acquiror ...

Makarim & Taira S. | March 2012

On 28 November 2012, the Capital Market – Financial Institutions Supervisory Board (Badan Pengawas Pasar Modal – Lembaga Keuangan or “BAPEPAM - LK”) issued a new regulation on Changes to Material Transactions and Main Business Activities, ie Decree of the Head of BAPEPAM-LK No. KEP-614/BL/2011 (“Regulation IX.E.2”) which revoked Decree of the Head of BAPEPAM-LK No. KEP-413/BL/2009 (“Previous Regulation”) on the same matter. Regulation IX.E ...

Shoosmiths LLP | March 2012

Today, Google have made the very interesting (but arguably provocative) move of completely rejecting the French data protection regulator's request to put a hold on the implementation of proposed changes to its privacy policies.  In doing so it has become the subject of a Europe-wide investigation. What has changed? Up until today, the information collected by Google on each of its platforms, such as Gmail and YouTube, was kept separate ...

Waller | February 2012

The Stage 2 Meaningful Use requirements proposed last week by CMS as part of the Medicare and Medicaid incentive programs to expand the use of Electronic Health Record (EHRs) maintain the same core and menu structure as the Stage 1 criteria. The proposed rule, however, gives providers an additional year, until 2014, to implement Stage 2 criteria ...

Waller | February 2012

Healthcare providers and other HIPAA covered entities have until Wednesday, February 29, 2012 to submit notice of breaches of unsecured Protected Health Information which affected fewer than 500 individuals during 2011. Notice must be submitted electronically to the Secretary of Health & Human Services, and separate forms are required for each data breach occurring in the course of the calendar year ...

Haynes and Boone, LLP | February 2012

The Centers for Medicare and Medicaid Services (CMS) on February 16, 2012 proposed rules1 implementing Section 6402(a) of the Affordable Care Act,2 requiring persons to report and return Medicare overpayments by the later of 60 days after an overpayment is identified or the date any corresponding cost report is due. Twice in the past, CMS had proposed rules requiring the return of Medicare overpayments, but did not finalize the regulations ...

Waller | February 2012

Only two days after the government’s announcement that it recovered a record-breaking $4.1 billion from its healthcare fraud enforcement efforts in 2011, the Centers for Medicare and Medicaid Services (CMS) published a draft regulation in today’s Federal Register implementing the Affordable Care Act’s (ACA) 60-day overpayment report and return provision ...

Haynes and Boone, LLP | February 2012

You are the general counsel of a public company, and your board and your CEO are considering the company’s strategic acquisition options. Your input is needed on the different forms that such a strategic transaction can take ...

Haynes and Boone, LLP | February 2012

The Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services has begun the pilot phase of HIPAA privacy and security audits of health care providers, health insurers and health care clearinghouses (“covered entities”) to assess HIPAA compliance efforts. Up to 150 covered entities will be subject to the initial audits, to be conducted by KPMG, LLP, the OCR audit contractor ...

PLMJ | February 2012

In its judgment of 19 January 2012 (case no. 08332/11), the Southern Central Administrative Court, decided that INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (the national authority for medicines and healthcare products), is obliged to issue a certificate of subsidisation of the price of a medicine even when the person requesting the issue of the certificate was not the person who applied for the subsidy ...

Haynes and Boone, LLP | February 2012

The United States Court of Appeals for the Fifth Circuit has confirmed that lower courts may use their discretion in choosing either of two methods - the "percentage method" or "lodestar method" - to calculate attorneys' fees in class action suits. The decision, in Union Asset Mgmt Holding A.G. v. Dell, Inc., 2012 WL 35249 (5th Cir. Feb. 7, 2012), affirmed a district court's use of the percentage method to calculate a $7.2 million fee award ...

In connection with the recent changes in legislation in the field of health, the Federal Commission for protection against health risks ("Cofepris") has taken various actions against the sale, distribution and advertising of the so-called "miracle products," which are distributed without scientific evidence to demonstrate its therapeutic properties ...

Haynes and Boone, LLP | January 2012

The Federal Trade Commission (FTC) recently announced its annual revisions to the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) jurisdictional thresholds. The revised thresholds will become effective 30 days after publication in the Federal Register and will apply to all transactions closing on or after such date. The new thresholds will remain in effect until the next annual adjustment, expected in the first quarter of 2013 ...

Haynes and Boone, LLP | January 2012

You’re the general counsel of a public company and your CEO calls you to tell you that he is interested in acquiring another public company. He’s already asking you how quickly this can get done and what the company needs to do. What are the first steps you should take? Board of Directors Generally, the CEO should call each of your board members individually to gauge their initial reaction toward the acquisition and schedule a special board meeting to discuss a potential transaction ...

Makarim & Taira S. | January 2012

Over the course of a few months spanning June to September 2011, a number of regulations were issued by the Business Competition Supervisory Commission (Komisi Pengawas Persaingan Usaha – “KPPU”) as implementing guidelines to several pertinent Articles in Law No. 5 of 1999 concerning Prohibition of Monopolistic Practices and Unfair Business Competition (“Anti-Monopoly Law”). These guidelines are: Guidelines for Monopolistic Practices (Regulation No ...

Makarim & Taira S. | January 2012

In order to provide extensive protection, especially for the distribution of drugs in Indonesia, BPOM has issued a new regulation which sets out the criteria and procedure for drug registration, ie BPOM Regulation No. HK.03.1.23.10.11.08481 of 2011 regarding The Criteria and Procedure For Drug Registration ...

Haynes and Boone, LLP | January 2012

Starting tomorrow, organizations may start submitting applications for new gTLDs (generic Top Level Domains). The application window will close on April 12, 2012. The new gTLDs move well beyond the core group of generic top level domains of .com, .net, .org, .biz, .info, and .edu. Specifically, they can consist of any combination of three or more letters that an applicant chooses ...

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Wardynski & Partners | January 2012

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Wardynski & Partners | January 2012

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