Member News

New European Guidance on the Qualification and Classification of Software as Medical Devices

By Irene Picciano and Elisa Stefanini of Portolano Cavallo Studio Legale In October 2019, the European Commission’s Medical Devices Coordination Group (MDCG) published a new guidance on the qualification and classification of software as medical devices (MDSW) under the new Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulations (IVDR) (the “Guidance”). The Guidance aims at providing clarification to medical software manufacturers with respect to (i) qualification issues (when software is considered a device); and (ii) classification issues, depending on...

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Member News

James D. Rosener and Brent A. Morowitz Interviewed during the Deal Economy Conference

James D. Rosener, partner in the Commercial Department of Pepper and head of the firm's International Practice Group, and Brent A. Morowitz, of counsel in the Corporate and Securities Practice Group of Pepper, were interviewed during The Deal Economy Conference. The conference focused on "Predictions and Perspectives" and explored the most effective strategies for deals and transactions, focusing on the opportunities and challenges facing dealmakers in 2019.  View interview here   Compliments of Pepper Hamilton, a Member of the EACCNY

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Chapter News

European Central Bank Monetary Policy Decisions

December 12 - At today’s meeting the Governing Council of the European Central Bank (ECB) decided that the interest rate on the main refinancing operations and the interest rates on the marginal lending facility and the deposit facility will remain unchanged at 0.00%, 0.25% and -0.50% respectively. The Governing Council expects the key ECB interest rates to remain at their present or lower levels until it has seen the inflation outlook robustly converge to a level sufficiently close to,...

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Member News

Managing Export Controls and Sanctions: It’s About Who You Know and What You Know

If you serve in a managerial or advisory role with a company that has foreign operations, suppliers or customers, several familiar phrases have probably caught your attention more often lately. Do “change to the entity list” and “new sanctions announced” sound familiar? Global policies and norms around the exchange of goods, services and ideas are in flux. Various countries, multinational organizations and multilateral treaties with their own best interests in mind are all attempting to regulate trade between foreign nationals...

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Member News

Germany: EIB Provides Funding of EUR 50 Million to BioNTech as Part of the Investment Plan for Europe

The European Investment Bank (EIB) and BioNTech SE (NASDAQ: BNTX, “BioNTech” or “the Company”) announced today the signing of a contract which provides financing of EUR 50 million to BioNTech SE, an international clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases. BioNTech will use the funds for the research and development, market access and manufacturing development for its most advanced treatments under development. The EU bank’s loan is backed by a guarantee...

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Chapter News

Main Results of the European Council

On 12 December, EU leaders discussed climate change, the EU's long-term budget and external relations, among other issues. On 13 December, they focused on the economic and monetary union and Brexit. Climate change EU leaders endorsed the objective of making the EU climate-neutral by 2050, in line with the Paris Agreement. They underlined that the transition to climate neutrality will bring significant opportunities for economic growth, markets, jobs and technological development. Poland, at this stage, could not commit to implementing this objective, which is why the European Council will come...

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Member News

Vulcan Insight: Analysis of the Latest EU Developments

Impact of Johnson Victory on Ireland The Conservative victory this morning was a clear triumph for Boris Johnson whose line “Get Brexit Done” brought out millions of new Tory voters despite horrendous weather conditions. The decisive nature of the victory has been welcomed in Dublin since it provides the clarity which has been sought for the past 3 years. Speaking this morning in Brussels the Taoiseach congratulated Johnson on his formidable victory and noted; “The next step is to ratify...

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Member News

USTR Announces Additional Exclusions Granted to SEC. 301 List 3 Products

On December 12, 2019, the U.S. Trade Representative (“USTR”) announced that 44 additional HTS provisions and product descriptions will be excluded from the Section 301 trade remedies imposed on Chinese-origin products. The newly announced exclusions all relate to items on China 301 List 3 (the $200 billion trade action) which, unless excluded, are subject to an additional tariff of 25% ad valorem. The list of newly-excluded items (which supplements the exclusions previously granted by the USTR) is provided below. The exclusions...

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Member News

Data Breaches in M&A Transactions: True Stories of Breaches and Lessons to Learn

Data is now one of the most valuable commodities in the world, with a market estimated at USD 92 billion globally by 2026.  Rapidly increasing values mean rapidly increasing responsibilities: this is why both the sellers’ and buyers’ approach to certain transactions has significantly changed over the past few months. It is hard to say at what particular stage of a transaction data and analytics are most impactful: certainly, “the sooner the better” saying seems to fit perfectly also in...

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Member News

Brexit Business Brief | What happens Now

The UK is set to leave the EU on 31 January 2020. With the Conservative Party now in a substantial majority in the House of Commons, it appears inevitable that the United Kingdom will leave the European Union at the end of January 2020 on the terms of the Withdrawal Agreement agreed on 19 October 2019. Here are the steps by which that departure is expected to happen. Step One: get the WAB into the UK statute book Mr Johnson has indicated...

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