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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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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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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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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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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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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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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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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OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE Docket No. USTR-2019-0003 Review of Action: Enforcement of U.S. WTO Rights in Large Civil Aircraft Dispute AGENCY: Office of the United States Trade Representative. ACTION: Request for comments. SUMMARY: The U.S. Trade Representative is reviewing the action being taken in the Section 301 investigation involving the enforcement of U.S. WTO rights in the Large Civil Aircraft dispute. Annex I to this notice contains a list of products currently subject to additional duties. Annex II contains...

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In response to growing concerns over climate change, and as part of broader efforts to connect finance with the specific needs of the European and global economy for the benefit of the planet and our society, the European Union has been examining how to integrate sustainability considerations into its financial policy framework in order to mobilise finance for sustainable growth. The action plan In March 2018, the European Commission published an action plan on sustainable finance (the “Action Plan”) specifically aiming...

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