On January 13, 2017, the U.S. Food and Drug Administration (FDA) issued a discussion paper1 in which the FDA announced that it would delay issuing final guidance on laboratory developed tests (LDTs).2 The FDA cited two reasons for the delay: i) to allow further public discussion on an appropriate oversight approach; and ii) to give Congress, via its oversight committees, the opportunity to develop a legislative solution to LDT oversight. In lieu of issuing final guidance, the FDA synthesized a...

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The Blue Star Strategies team would like to thank you for all your support this past year. We remain dedicated to our mission of providing our clients and partners with focused attention, results oriented strategies, and practical solutions. We begin this new year in the Janus* tradition of reflecting back and looking ahead by recognizing that our work is a continuous journey. In this way, we look forward to building on recent achievements and to working towards marking new and exciting milestones with you...

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New York City offers some of the best, most effective economic incentive programs in the nation.  These programs afford businesses, not-for-profits, and communities the opportunity to foster growth. The city provides a multitude of incentive programs targeting expansion/relocation of business, growth of targeted industries and attraction of other companies outside the state. Timing is key. Below are only some of the Incentive Programs Due to Expire PROGRAM DESCRIPTION EXPIRATION DATE Relocation Employment Assistance Program (REAP) A 12 year annual business income tax credit of up to $3,000 for each...

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The group headquarters' e-mail seemed unspectacular at first glance: "Please provide us with a complete list of all employees working at your company including details regarding age, entry date, position and remuneration by tomorrow, COB." The HR department addressed was able to quickly compile the list and sent it to headquarters without further inquiry. It was overlooked – as is often the case – that this transfer entails significant risks under European data protection law. Data transfers between group companies...

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As the apps were a paradigm shift of customers going more towards mobile solutions, the chatbot hype shows similarities to such a shift. With app downloads and retention decreasing, not to mention the fact that a user uses only a few apps per day, companies are looking for creative and innovative ways to engage customers better, provide improved customer service and to analyze and respond to trends in real-time. Enter the chatbot. These conversational agents, software programs use messaging to...

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Luxottica Group SpA (LUX) and Essilor International SA announced Monday, Jan. 16, that they would merge, creating an eyewear giant with combined revenues of over €15 billion ($15.96 billion). The combined company will have a market value of over €46 billion based on the companies' respective Friday closing market capitalizations.  The companies said in a statement that they will also have combined net Ebitda of about €3.5 billion (derived from their 2015 results). In the medium term, they expect revenue and cost synergies of €400 million...

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Summary: Over the past several years, the United States Supreme Court has become increasingly involved in the area of intellectual property law.  During that time, the Court has issued significant decisions on, among other things, patent eligibility, indirect infringement, the definiteness requirement, enhanced damages and fee shifting.  The renewed focus on intellectual property law appears poised to continue into 2017, with the Supreme Court scheduled to issue decisions addressing a variety of issues, including venue in patent cases, the functionality...

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On January 9, 2017, the U.S. Court of Appeals for the Federal Circuit issued a decision in Phigenix, Inc. v. Immunogen, Inc.1 dismissing an appeal by a petitioner from the Patent Trial and Appeal Board (PTAB) for lack of standing. The court held that a petitioner must be able to prove a case or controversy in its opening brief to establish its right to be heard on appeal. Background In 2011, Congress created new processes for challenging the patentability of patent...

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On 30 November the European Commission published its long awaited Final Report on the capacity mechanism sector inquiry in the electricity market. The report is complemented by the “Clean Energy for All Europeans” package which will create a European legal framework for capacity mechanisms, introduce concrete rules for cross-border participation and lead to the integration of capacity markets. This new legal framework will clarify state aid assessment of capacity mechanisms by the Commission. Capacity mechanisms are support mechanisms set up by...

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According to Secretary of Labor Thomas Perez, the “largest question” for the incoming administration will be how to “embrace innovation” as part of the changing nature of work, while ensuring a level of workforce protections for participants in the on-demand economy. In his Memorandum to the American People, Perez highlighted the Department of Labor’s regulatory and policy achievements over the past eight years, called on the new Congress to enact federal employment legislation, and urged the DOL under President-elect Trump...

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