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 ...
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On Monday December 19, 2011, the Department of Justice announced year-end results for False Claims Act (“FCA”) cases in fiscal year 2011. The results, summarized below, demonstrate a dramatic increase in FCA cases brought by the government and private whistleblowers. The pharmaceutical industry is the prime target at the moment, but companies with defense contracts, federal subsidies and loans, and government contracts more generally are on the enforcement radar ...
The role, and especially the liability, of corporate directors have evolved considerably over the last few decades. Obviously, the financial scandals of the 1990s are largely responsible for this change that began in the United Stated with the enactment of the Sarbanes-Oxley Act of 200, prompting Canadian authorities to follow suit with the adoption of more stringent securities regulations ...
TO REMEMBER •The establishment of good governance practices is useful if not essential for SMEs, their directors, shareholders and managers. •Good governance practices can protect directors against their risks of liability.•Governance must be adapted to the realities of SMEs* This adaptation is achieved by a combination of informal measures and a few formal measures ...
TO REMEMBER - The establishment of good governance practices is useful if not essential for SMEs, their directors, shareholders and managers. Good governance practices can protect directors against their risks of liability. Governance must be adapted to the realities of SMEs. This adaptation is achieved by a combination of informal measures and a few formal measures ...
The Regulations on Contracting the Provision of Foreign Technical Assistance and Management Services, as provided for in Presidential Decree 273/11 of 27 October (the “Decree”), were published recently. This legislation has great relevance, on the one hand, because it aims to cover contracts for the provision of services made with non-resident entities and, on the other hand, because it introduces a number of new obligations for the parties involved in these contracts ...
You are the general counsel of a public company and your company is entering into a transaction to be acquired by another company. Your board and your stockholders want you to make sure the transaction is consummated but they also want you to make sure the company gets the best deal for its stockholders. The acquiror is also going to demand a certain level of deal security ...
The United States Court of Appeals for the D.C. Circuit recently held that a complaint does not need to meet the heightened pleading standards for fraud claims in order to satisfy the first-to-file rule under the False Claims Act (“FCA”). The first-to-file rule provides that, once a private plaintiff brings suit under the FCA, no one other than the government may intervene or bring a related suit “based on the facts underlying the pending action.” 31 U.S.C. § 3730(b)(5) ...
On October 28, 2011, the United States Bankruptcy Court for the Eastern District of Virginia issued an opinion in the Chapter 15 case of Qimonda AG (“Qimonda”).1 The bankruptcy court held that the application of § 365(n) to executory licenses to U.S. patents was required to sufficiently protect the interests of U.S ...
Rejection of a contract in bankruptcy may not always accomplish a debtor’s goal to shed ongoing contractual obligations and liabilities, especially when dealing with employee benefit plans. On October 13, 2011, the Fifth Circuit Court of Appeals highlighted this issue in its opinion in Evans v. Sterling Chemicals, Inc ...
After a public consultation phase initiated at the end of 2010, the Portuguese Competition Authority (“PCA”) made available, at the end of July 2011, the final version of its “Guidelines on the Adoption of Remedies in the Control of Concentrations” (“Guidelines”). As clarified by the PCA, the Guidelines are “a set of de indications pertaining to the selection, design, execution and monitoring of remedies, within the procedure of previous control of concentrations between undertakings” ...
You’re the general counsel of a public company and you find out that one of your company’s stockholders intends to wage a proxy contest. Your board of directors and CEO are going to want some answers right away. How prepared are you and how do you respond? The average annual number of proxy contests has nearly doubled from 60 in 2001-2005 to 112 in 2006-2010. In 2009, activist shareholders were able to successfully gain board seats approximately 43 percent of the time ...
Although the currently effective Hungarian Civil Code does not name a call option as security, it does not prohibit the use of a call option as security either. The first question this raises, therefore, is whether Hungarian law permits the use of a call option as security? Naturally, this then creates more questions ...
As part of the implementation or reorganization of a business structure, the integration of a trust as a shareholder of an incorporated family business can prove to be an interesting tax and estate-planning tool. This holding vehicle is being used more and more in Quebec.INTEGRATING A TRUST AS A SHAREHOLDER OF YOUR FAMILY BUSINESSDIANA DARILUS ddarilus@lavery ...
This paper reviews judgments dealing with contract law issues relevant to commercial lawyers and business leaders. This paper also considers private international law conventions and treaties that are en route to domestic implementation, and are therefore relevant to commercial practice ...
On September 13, 2011, the Board of Directors of the Federal Deposit Insurance Corporation (“FDIC”) unanimously approved a final rule implementing Section 165(d) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Rule”) ...
The Ministry of Health recently issued Minister of Health Regulation No. 1148/Menkes/Per/VI/2011 on Pharmaceutical Wholesalers, which replaces and repeals two earlier decrees. The new regulation is aimed at protecting the public from dangerous drugs and drugs materials as well as improving previous regulations on pharmaceutical drugs ...
A new Regulation of the Minister of Law and Human Rights No. M.HH-01. AH.01.01 of 2011 on the Application Procedures for Validating a Legal Entity and Approving Amendments to the Articles of Association and the Notification Procedures for Amendments to the Articles of Association and Changes to Company Data (the “MOLHR Regulation”) was issued on 1st April 2011 ...
The Minister of Forestry has issued Regulation No. P.18/Menhut-II/2011 on Guidelines for Borrow-to-Use Permits for Forest Areas (“MOF Regulation”), which replaces and repeals Minister of Forestry Regulation Number P.43/Menhut-II/2008. This new MOF Regulation is the implementing regulation of Government Regulation No. 24 of 2010 on Forest Area Utilization ...
Adopting a related party transactions policy, with supporting protocols and procedures, will help to identify and deal with related party transactions within the corporation. Ultimately, this will reduce the risk of breaching the Corporations Act 2001 (Cth) or ASX Listing Rules (if relevant) and will protect shareholders' interests ...
