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As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\u003c/p\u003e\n\u003cp\u003eBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChris has been recognized by the\u0026nbsp;\u003cem\u003eBTI Consulting Group\u003c/em\u003e\u0026nbsp;as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by\u0026nbsp;\u003cem\u003eLMG Life Sciences.\u003c/em\u003e\u0026nbsp; She continues to be identified as one of\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;for FDA Law, and ranked as a life sciences practitioner by\u0026nbsp;\u003cem\u003eThe Legal 500\u003c/em\u003e.\u003c/p\u003e","slug":"christina-markus","email":"cmarkus@kslaw.com","phone":null,"matters":["\u003cp\u003eAdvised numerous pharmaceutical and device manufacturers and distributors on compliance with\u0026nbsp;\u003cstrong\u003estate laws\u003c/strong\u003e\u0026nbsp;governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.\u003c/p\u003e","\u003cp\u003eAdvised on range of clinical trial issues, including design, compliance and transparency disclosures.\u003c/p\u003e","\u003cp\u003eDeveloped responses to inspectional findings and import alerts, in close collaboration with technical experts.\u003c/p\u003e","\u003cp\u003eAdvised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003edozens of pharmaceutical and biological product companies\u003c/strong\u003e, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.\u003c/p\u003e","\u003cp\u003eDeveloped and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed\u0026nbsp;\u003cstrong\u003ebioequivalence standards, Hatch-Waxman 30-month stay provisions\u003c/strong\u003e, and other key regulatory topics.\u003c/p\u003e","\u003cp\u003ePerformed due diligence for\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eregulatory issues\u003c/strong\u003e\u0026nbsp;and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.\u003c/p\u003e","\u003cp\u003eEvaluated\u0026nbsp;\u003cstrong\u003eimpacts of the Drug Supply Chain Security Act (DSCSA)\u003c/strong\u003e\u0026nbsp;on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eproduct distributors\u003c/strong\u003e\u0026nbsp;against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.\u003c/p\u003e","\u003cp\u003eAdvised on the status and use of controlled substances\u0026nbsp;\u003cstrong\u003eand listed chemicals\u003c/strong\u003e, including:\u003c/p\u003e\n\u003cp\u003e- Administrative hearings concerning applicants for registration to import narcotic raw materials,\u003c/p\u003e\n\u003cp\u003e- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\u003c/p\u003e\n\u003cp\u003e- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\u003c/p\u003e\n\u003cp\u003e- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.smart_tags","index":1,"source":"smartTags"},{"id":107,"guid":"107.capabilities","index":2,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":3,"source":"smartTags"},{"id":105,"guid":"105.capabilities","index":4,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":5,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":6,"source":"capabilities"},{"id":24,"guid":"24.capabilities","index":7,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":8,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":9,"source":"capabilities"},{"id":33,"guid":"33.capabilities","index":10,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":11,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":12,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":13,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":14,"source":"smartTags"}],"is_active":true,"last_name":"Markus","nick_name":"Chris","clerkships":[],"first_name":"Christina","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"Client Service All-Star (unprompted survey of large company corporate counsel)","detail":"BTI Consulting, 2017"},{"title":"Who's Who Legal: Life Sciences","detail":"2017-2024"},{"title":"Leading Life Sciences Lawyer","detail":"LMG Life Sciences, 2012-2025"},{"title":"Best Lawyers in America - FDA Law","detail":"Best Lawyers/US News \u0026 World Report, 2015-2026"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eChris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\u003c/p\u003e\n\u003cp\u003eBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eChris has been recognized by the\u0026nbsp;\u003cem\u003eBTI Consulting Group\u003c/em\u003e\u0026nbsp;as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by\u0026nbsp;\u003cem\u003eLMG Life Sciences.\u003c/em\u003e\u0026nbsp; She continues to be identified as one of\u0026nbsp;\u003cem\u003eThe Best Lawyers in America\u003c/em\u003e\u0026nbsp;for FDA Law, and ranked as a life sciences practitioner by\u0026nbsp;\u003cem\u003eThe Legal 500\u003c/em\u003e.\u003c/p\u003e","matters":["\u003cp\u003eAdvised numerous pharmaceutical and device manufacturers and distributors on compliance with\u0026nbsp;\u003cstrong\u003estate laws\u003c/strong\u003e\u0026nbsp;governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.\u003c/p\u003e","\u003cp\u003eAdvised on range of clinical trial issues, including design, compliance and transparency disclosures.\u003c/p\u003e","\u003cp\u003eDeveloped responses to inspectional findings and import alerts, in close collaboration with technical experts.\u003c/p\u003e","\u003cp\u003eAdvised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.\u003c/p\u003e","\u003cp\u003eAdvised\u0026nbsp;\u003cstrong\u003edozens of pharmaceutical and biological product companies\u003c/strong\u003e, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.\u003c/p\u003e","\u003cp\u003eDeveloped and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed\u0026nbsp;\u003cstrong\u003ebioequivalence standards, Hatch-Waxman 30-month stay provisions\u003c/strong\u003e, and other key regulatory topics.\u003c/p\u003e","\u003cp\u003ePerformed due diligence for\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eregulatory issues\u003c/strong\u003e\u0026nbsp;and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.\u003c/p\u003e","\u003cp\u003eEvaluated\u0026nbsp;\u003cstrong\u003eimpacts of the Drug Supply Chain Security Act (DSCSA)\u003c/strong\u003e\u0026nbsp;on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.\u003c/p\u003e","\u003cp\u003eDefended\u0026nbsp;\u003cstrong\u003eproduct distributors\u003c/strong\u003e\u0026nbsp;against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.\u003c/p\u003e","\u003cp\u003eAdvised on the status and use of controlled substances\u0026nbsp;\u003cstrong\u003eand listed chemicals\u003c/strong\u003e, including:\u003c/p\u003e\n\u003cp\u003e- Administrative hearings concerning applicants for registration to import narcotic raw materials,\u003c/p\u003e\n\u003cp\u003e- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\u003c/p\u003e\n\u003cp\u003e- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\u003c/p\u003e\n\u003cp\u003e- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.\u003c/p\u003e"],"recognitions":[{"title":"Client Service All-Star (unprompted survey of large company corporate counsel)","detail":"BTI Consulting, 2017"},{"title":"Who's Who Legal: Life Sciences","detail":"2017-2024"},{"title":"Leading Life Sciences Lawyer","detail":"LMG Life Sciences, 2012-2025"},{"title":"Best Lawyers in America - FDA Law","detail":"Best Lawyers/US News \u0026 World Report, 2015-2026"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1035}]},"capability_group_id":2},"created_at":"2025-11-05T05:04:00.000Z","updated_at":"2025-11-05T05:04:00.000Z","searchable_text":"Markus{{ FIELD }}{:title=\u0026gt;\"Client Service All-Star (unprompted survey of large company corporate counsel)\", :detail=\u0026gt;\"BTI Consulting, 2017\"}{{ FIELD }}{:title=\u0026gt;\"Who's Who Legal: Life Sciences\", :detail=\u0026gt;\"2017-2024\"}{{ FIELD }}{:title=\u0026gt;\"Leading Life Sciences Lawyer\", :detail=\u0026gt;\"LMG Life Sciences, 2012-2025\"}{{ FIELD }}{:title=\u0026gt;\"Best Lawyers in America - FDA Law\", :detail=\u0026gt;\"Best Lawyers/US News \u0026amp; World Report, 2015-2026\"}{{ FIELD }}Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting.{{ FIELD }}Advised on range of clinical trial issues, including design, compliance and transparency disclosures.{{ FIELD }}Developed responses to inspectional findings and import alerts, in close collaboration with technical experts.{{ FIELD }}Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples.{{ FIELD }}Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence.{{ FIELD }}Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics.{{ FIELD }}Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending.{{ FIELD }}Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products.{{ FIELD }}Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions.{{ FIELD }}Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.{{ FIELD }}Chris Markus focuses on U.S. federal and state regulation of drugs, biologics, biotechnology and related products. As a partner in our FDA and Life Sciences practice and Deputy Practice Group Leader, Chris represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.\nChris represents drug, biologic and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA) and related state agencies such as Boards of Pharmacy. She also represents clients in business transactions, including strategic planning, due diligence and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing and supply chain.\nBased on her experience, Chris was chosen to serve as the legal member of the Institute of Medicine's Committee on Pediatric Studies conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. IOM evaluated studies of drugs and biologics performed under two statutory regimes that provide incentives and, in some instances, mandate pediatric research through the drug approval process. The Committee assessed the findings and offered recommendations and briefings to FDA and the U.S. Congress. \nChris has been recognized by the BTI Consulting Group as a 2017 \"Client Service All-Star\" and named repeatedly as a \"Life Sciences Star\" by LMG Life Sciences.  She continues to be identified as one of The Best Lawyers in America for FDA Law, and ranked as a life sciences practitioner by The Legal 500. Partner Client Service All-Star (unprompted survey of large company corporate counsel) BTI Consulting, 2017 Who's Who Legal: Life Sciences 2017-2024 Leading Life Sciences Lawyer LMG Life Sciences, 2012-2025 Best Lawyers in America - FDA Law Best Lawyers/US News \u0026amp; World Report, 2015-2026 College of William and Mary William \u0026amp; Mary Law School University of Virginia University of Virginia School of Law District of Columbia Virginia The District of Columbia Bar Virginia State Bar Advised numerous pharmaceutical and device manufacturers and distributors on compliance with state laws governing operating entity licensure (including for \"virtual\" companies), extended producer responsibility (drug and sharps take back laws) and product distribution monitoring and reporting. Advised on range of clinical trial issues, including design, compliance and transparency disclosures. Developed responses to inspectional findings and import alerts, in close collaboration with technical experts. Advised on the Prescription Drug Marketing Act (PDMA) and state-specific requirements concerning the distribution and reporting of prescription, over-the-counter, and controlled drug samples. Advised dozens of pharmaceutical and biological product companies, and investors, on life cycle issues, including patent and market exclusivity eligibility, regulatory strategies, and transactional diligence. Developed and responded to citizen petition elucidating legal and scientific concerns about FDA's proposed bioequivalence standards, Hatch-Waxman 30-month stay provisions, and other key regulatory topics. Performed due diligence for regulatory issues and supported negotiation for corporate licensing, M\u0026amp;A, equity investing and financial institution lending. Evaluated impacts of the Drug Supply Chain Security Act (DSCSA) on manufacturers, distributors, and third-party logistics providers of drugs, medical devices and combination products. Defended product distributors against proposed disciplinary action by the California Board of Pharmacy; Alabama Board of Pharmacy, and other jurisdictions. Advised on the status and use of controlled substances and listed chemicals, including:\n- Administrative hearings concerning applicants for registration to import narcotic raw materials,\n- Representation of a reverse distributor before DEA and state agencies to untangle registration issues arising in a multi-faceted corporate transaction, without penalty to the acquiring company,\n- Applied listed chemical requirements impacting an industrial chemical importer's supply chain, and\n- Facilitated DEA scheduling of a new chemical entity completing the FDA approval process.","searchable_name":"Christina M. Markus (Chris)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":436361,"version":1,"owner_type":"Person","owner_id":2118,"payload":{"bio":"\u003cp\u003eKatie McCarthy focuses on trademark, copyright, design, advertising and internet law. As a partner in our Intellectual Property, Patent, Trademark and Copyright Litigation practice, Katie represents clients in a wide array of industries including consumer products, pharmaceuticals, retail, internet services, sports and entertainment, cosmetics, and food and beverages. Katie appears on behalf of clients in federal court and before the U.S. Patent and Trademark Office's Trademark Trial and Appeal Board. Katie also develops domestic and international protection and enforcement programs.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDuring her more than 30 years of experience, Katie has first-chaired numerous trials and preliminary injunction hearings. Katie actively polices online infringement and scams for several clients. In addition to litigation and contested matters, Katie directs international and domestic trademark clearance and prosecution programs, manages domain name disputes and acquisitions, and develops social media and other intellectual property-related policies.\u003c/p\u003e\n\u003cp\u003eKatie also counsels clients on a broad range of IP-related matters, helping to find creative and practical solutions to legal challenges, and developing legal strategies and policies that advance their business goals.\u003c/p\u003e\n\u003cp\u003eKatie has served on the Board of the New York Intellectual Property Law Association for years, recently finishing a term as President during which she organized and moderated a forum of key discussion leaders debating online platform liability. Katie served as Editor-in-Chief of the International Trademark Association peer-reviewed scholarly journal,\u0026nbsp;\u003cem\u003eThe Trademark Reporter\u003c/em\u003e, having\u003cem\u003e\u0026nbsp;\u003c/em\u003eserved on the committee soliciting and editing articles for the journal for more than 20 years. Katie\u0026rsquo;s article, \u0026ldquo;Free Ride or Free Speech: Predicting Results and Providing Advice for Trademark Disputes Involving Parody\u0026rdquo; won INTA\u0026rsquo;s 2020 Ladas Memorial Award for best paper in the professional category. Katie has presented at and co-chaired PLI's IP Enforcement Update program annually since 2011 and frequently writes and speaks for PLI, INTA, NYIPLA and other organizations on trademark, copyright and false advertising topics.\u0026nbsp; Katie is the author of PLI\u0026rsquo;s one volume treatise, \u0026ldquo;Kane on Trademark Law: A Practitioner\u0026rsquo;s Guide.\u0026rdquo;\u003c/p\u003e\n\u003cp\u003eKatie has been recognized in the 2012\u0026ndash;2016 editions of\u0026nbsp;\u003cem\u003eLegal 500\u003c/em\u003e\u0026nbsp;for her trademark work.\u003c/p\u003e","slug":"kathleen-mccarthy","email":"kmccarthy@kslaw.com","phone":null,"matters":["\u003cp\u003eA Better Choice Lock \u0026amp; Key LLC v.\u0026nbsp;\u003cstrong\u003eGoogle Inc.\u003c/strong\u003e\u0026nbsp;et al (DC Cir., filed 2016) (Lead counsel for defendant in Lanham Act, antitrust class action case with CDA Section 230 defense motion to dismiss granted and affirmed on appeal in precedential decision).\u003c/p\u003e","\u003cp\u003eBaldino\u0026rsquo;s Lock \u0026amp; Key Inc. v.\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eGoogle Inc.\u003c/strong\u003e\u0026nbsp;et al (EDVA and 4th Cir., filed 2014) (Lead counsel for defendant securing CDA Section 230 defense on motion to dismiss in case involving Lanham Act and RICO claims).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eValerus Field Solutions LP\u003c/strong\u003e\u0026nbsp;v. Valerus Specialty Chemicals (SDTX, filed 2015) (Lead counsel for plaintiff in trademark infringement action, securing settlement prior to preliminary injunction motion).\u003c/p\u003e","\u003cp\u003eOn Site Energy Co. v.\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eMTU Onsite Energy\u003c/strong\u003e\u0026nbsp;(EDNY, filed 2010; jury trial August 2012) (Lead counsel in trademark infringement action challenging the use of the term ON SITE ENERGY in connection with power generators, securing jury verdict for the defense).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eSpanx, Inc.\u003c/strong\u003e\u0026nbsp;v. Times Three Clothiers d/b/a Yummie Tummie (NDGA, SDNY, filed 2013) (Lead counsel in design patent infringement declaratory judgment action and related design patent and utility patent infringement action, securing decision invalidating two patents with case resolved and dismissed thereafter).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eFritz Hansen A/S\u003c/strong\u003e\u0026nbsp;v. Restoration Hardware (SDNY, filed 2013) (Lead counsel in trademark and trade dress infringement action involving copies of chair designs, securing resolution).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc\u003c/strong\u003e. v. PRL Holdings (SDNY 2012) (Lead counsel in appeal of TTAB decision involving marks RLX RALPH LAUREN and RALPH LAUREN RLX, securing resolution prior to trial). Prior cases include:\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Capetown Diamond Corp. et al (N.D. Georgia 2003-2007) (Lead counsel in the latest of a series of cases establishing that genuine Rolex watches altered with non-genuine integral parts such as diamond bezels and bracelets are counterfeit);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Town \u0026amp; Country Jewelers (2005);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. JBJ Distributors, Inc. (5th Cir. July 29, 2003) (per curiam);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Zeotec Diamonds, Inc., 2003 U.S. Dist. LEXIS 5595 (C.D. Cal., Mar. 7, 2003) (Lead counsel);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Michel Co., 179 F.3d 704 (9th Cir. 1999);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Meece, 158 F.3d 816 (5th Cir. 1998).\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":74,"guid":"74.capabilities","index":0,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":1,"source":"capabilities"},{"id":3,"guid":"3.capabilities","index":2,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":3,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":4,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":5,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":6,"source":"capabilities"},{"id":763,"guid":"763.smart_tags","index":7,"source":"smartTags"},{"id":103,"guid":"103.capabilities","index":8,"source":"capabilities"},{"id":764,"guid":"764.smart_tags","index":9,"source":"smartTags"},{"id":1203,"guid":"1203.smart_tags","index":10,"source":"smartTags"},{"id":970,"guid":"970.smart_tags","index":11,"source":"smartTags"},{"id":109,"guid":"109.capabilities","index":12,"source":"capabilities"},{"id":112,"guid":"112.capabilities","index":13,"source":"capabilities"},{"id":1233,"guid":"1233.smart_tags","index":14,"source":"smartTags"}],"is_active":true,"last_name":"McCarthy","nick_name":"Katie","clerkships":[],"first_name":"Kathleen","title_rank":9999,"updated_by":101,"law_schools":[{"id":485,"meta":{"degree":"J.D.","honors":"Harlan Fiske Stone Scholar","is_law_school":1,"graduation_date":"1986-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"E.","name_suffix":"","recognitions":[{"title":"Named as a recommended lawyer for Trademarks: Non-Contentious and Tradmarks: Litigation","detail":"Legal 500, 2022"},{"title":"Named for Trademark Law","detail":"Best Lawyers, 2023"},{"title":"Named a Trademark Star nationwide and in New York","detail":"Managing Intellectual Property, 2022"},{"title":"Ranked for Trademark Law nationwide and in New York","detail":"World Trademark Review 1000"},{"title":"Named to Managing Intellectual Property’s Global Top 250 Women in IP","detail":"Managing Intellectual Property, 2020"}],"linked_in_url":"https://www.linkedin.com/in/kathleenekatiemccarthy/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eKatie McCarthy focuses on trademark, copyright, design, advertising and internet law. As a partner in our Intellectual Property, Patent, Trademark and Copyright Litigation practice, Katie represents clients in a wide array of industries including consumer products, pharmaceuticals, retail, internet services, sports and entertainment, cosmetics, and food and beverages. Katie appears on behalf of clients in federal court and before the U.S. Patent and Trademark Office's Trademark Trial and Appeal Board. Katie also develops domestic and international protection and enforcement programs.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDuring her more than 30 years of experience, Katie has first-chaired numerous trials and preliminary injunction hearings. Katie actively polices online infringement and scams for several clients. In addition to litigation and contested matters, Katie directs international and domestic trademark clearance and prosecution programs, manages domain name disputes and acquisitions, and develops social media and other intellectual property-related policies.\u003c/p\u003e\n\u003cp\u003eKatie also counsels clients on a broad range of IP-related matters, helping to find creative and practical solutions to legal challenges, and developing legal strategies and policies that advance their business goals.\u003c/p\u003e\n\u003cp\u003eKatie has served on the Board of the New York Intellectual Property Law Association for years, recently finishing a term as President during which she organized and moderated a forum of key discussion leaders debating online platform liability. Katie served as Editor-in-Chief of the International Trademark Association peer-reviewed scholarly journal,\u0026nbsp;\u003cem\u003eThe Trademark Reporter\u003c/em\u003e, having\u003cem\u003e\u0026nbsp;\u003c/em\u003eserved on the committee soliciting and editing articles for the journal for more than 20 years. Katie\u0026rsquo;s article, \u0026ldquo;Free Ride or Free Speech: Predicting Results and Providing Advice for Trademark Disputes Involving Parody\u0026rdquo; won INTA\u0026rsquo;s 2020 Ladas Memorial Award for best paper in the professional category. Katie has presented at and co-chaired PLI's IP Enforcement Update program annually since 2011 and frequently writes and speaks for PLI, INTA, NYIPLA and other organizations on trademark, copyright and false advertising topics.\u0026nbsp; Katie is the author of PLI\u0026rsquo;s one volume treatise, \u0026ldquo;Kane on Trademark Law: A Practitioner\u0026rsquo;s Guide.\u0026rdquo;\u003c/p\u003e\n\u003cp\u003eKatie has been recognized in the 2012\u0026ndash;2016 editions of\u0026nbsp;\u003cem\u003eLegal 500\u003c/em\u003e\u0026nbsp;for her trademark work.\u003c/p\u003e","matters":["\u003cp\u003eA Better Choice Lock \u0026amp; Key LLC v.\u0026nbsp;\u003cstrong\u003eGoogle Inc.\u003c/strong\u003e\u0026nbsp;et al (DC Cir., filed 2016) (Lead counsel for defendant in Lanham Act, antitrust class action case with CDA Section 230 defense motion to dismiss granted and affirmed on appeal in precedential decision).\u003c/p\u003e","\u003cp\u003eBaldino\u0026rsquo;s Lock \u0026amp; Key Inc. v.\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eGoogle Inc.\u003c/strong\u003e\u0026nbsp;et al (EDVA and 4th Cir., filed 2014) (Lead counsel for defendant securing CDA Section 230 defense on motion to dismiss in case involving Lanham Act and RICO claims).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eValerus Field Solutions LP\u003c/strong\u003e\u0026nbsp;v. Valerus Specialty Chemicals (SDTX, filed 2015) (Lead counsel for plaintiff in trademark infringement action, securing settlement prior to preliminary injunction motion).\u003c/p\u003e","\u003cp\u003eOn Site Energy Co. v.\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eMTU Onsite Energy\u003c/strong\u003e\u0026nbsp;(EDNY, filed 2010; jury trial August 2012) (Lead counsel in trademark infringement action challenging the use of the term ON SITE ENERGY in connection with power generators, securing jury verdict for the defense).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eSpanx, Inc.\u003c/strong\u003e\u0026nbsp;v. Times Three Clothiers d/b/a Yummie Tummie (NDGA, SDNY, filed 2013) (Lead counsel in design patent infringement declaratory judgment action and related design patent and utility patent infringement action, securing decision invalidating two patents with case resolved and dismissed thereafter).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eFritz Hansen A/S\u003c/strong\u003e\u0026nbsp;v. Restoration Hardware (SDNY, filed 2013) (Lead counsel in trademark and trade dress infringement action involving copies of chair designs, securing resolution).\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc\u003c/strong\u003e. v. PRL Holdings (SDNY 2012) (Lead counsel in appeal of TTAB decision involving marks RLX RALPH LAUREN and RALPH LAUREN RLX, securing resolution prior to trial). Prior cases include:\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Capetown Diamond Corp. et al (N.D. Georgia 2003-2007) (Lead counsel in the latest of a series of cases establishing that genuine Rolex watches altered with non-genuine integral parts such as diamond bezels and bracelets are counterfeit);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Town \u0026amp; Country Jewelers (2005);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. JBJ Distributors, Inc. (5th Cir. July 29, 2003) (per curiam);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Zeotec Diamonds, Inc., 2003 U.S. Dist. LEXIS 5595 (C.D. Cal., Mar. 7, 2003) (Lead counsel);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Michel Co., 179 F.3d 704 (9th Cir. 1999);\u003c/p\u003e","\u003cp\u003e\u003cstrong data-redactor-tag=\"strong\"\u003eRolex Watch U.S.A., Inc.\u003c/strong\u003e\u0026nbsp;v. Meece, 158 F.3d 816 (5th Cir. 1998).\u003c/p\u003e"],"recognitions":[{"title":"Named as a recommended lawyer for Trademarks: Non-Contentious and Tradmarks: Litigation","detail":"Legal 500, 2022"},{"title":"Named for Trademark Law","detail":"Best Lawyers, 2023"},{"title":"Named a Trademark Star nationwide and in New York","detail":"Managing Intellectual Property, 2022"},{"title":"Ranked for Trademark Law nationwide and in New York","detail":"World Trademark Review 1000"},{"title":"Named to Managing Intellectual Property’s Global Top 250 Women in IP","detail":"Managing Intellectual Property, 2020"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":4266},{"id":4266}]},"capability_group_id":3},"created_at":"2025-09-02T04:50:27.000Z","updated_at":"2025-09-02T04:50:27.000Z","searchable_text":"McCarthy{{ FIELD }}{:title=\u0026gt;\"Named as a recommended lawyer for Trademarks: Non-Contentious and Tradmarks: Litigation\", :detail=\u0026gt;\"Legal 500, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Named for Trademark Law\", :detail=\u0026gt;\"Best Lawyers, 2023\"}{{ FIELD }}{:title=\u0026gt;\"Named a Trademark Star nationwide and in New York\", :detail=\u0026gt;\"Managing Intellectual Property, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Ranked for Trademark Law nationwide and in New York\", :detail=\u0026gt;\"World Trademark Review 1000\"}{{ FIELD }}{:title=\u0026gt;\"Named to Managing Intellectual Property’s Global Top 250 Women in IP\", :detail=\u0026gt;\"Managing Intellectual Property, 2020\"}{{ FIELD }}A Better Choice Lock \u0026amp; Key LLC v. Google Inc. et al (DC Cir., filed 2016) (Lead counsel for defendant in Lanham Act, antitrust class action case with CDA Section 230 defense motion to dismiss granted and affirmed on appeal in precedential decision).{{ FIELD }}Baldino’s Lock \u0026amp; Key Inc. v. Google Inc. et al (EDVA and 4th Cir., filed 2014) (Lead counsel for defendant securing CDA Section 230 defense on motion to dismiss in case involving Lanham Act and RICO claims).{{ FIELD }}Valerus Field Solutions LP v. Valerus Specialty Chemicals (SDTX, filed 2015) (Lead counsel for plaintiff in trademark infringement action, securing settlement prior to preliminary injunction motion).{{ FIELD }}On Site Energy Co. v. MTU Onsite Energy (EDNY, filed 2010; jury trial August 2012) (Lead counsel in trademark infringement action challenging the use of the term ON SITE ENERGY in connection with power generators, securing jury verdict for the defense).{{ FIELD }}Spanx, Inc. v. Times Three Clothiers d/b/a Yummie Tummie (NDGA, SDNY, filed 2013) (Lead counsel in design patent infringement declaratory judgment action and related design patent and utility patent infringement action, securing decision invalidating two patents with case resolved and dismissed thereafter).{{ FIELD }}Fritz Hansen A/S v. Restoration Hardware (SDNY, filed 2013) (Lead counsel in trademark and trade dress infringement action involving copies of chair designs, securing resolution).{{ FIELD }}Rolex Watch U.S.A., Inc. v. PRL Holdings (SDNY 2012) (Lead counsel in appeal of TTAB decision involving marks RLX RALPH LAUREN and RALPH LAUREN RLX, securing resolution prior to trial). Prior cases include: Rolex Watch U.S.A., Inc. v. Capetown Diamond Corp. et al (N.D. Georgia 2003-2007) (Lead counsel in the latest of a series of cases establishing that genuine Rolex watches altered with non-genuine integral parts such as diamond bezels and bracelets are counterfeit);{{ FIELD }}Rolex Watch U.S.A., Inc. v. Town \u0026amp; Country Jewelers (2005);{{ FIELD }}Rolex Watch U.S.A., Inc. v. JBJ Distributors, Inc. (5th Cir. July 29, 2003) (per curiam);{{ FIELD }}Rolex Watch U.S.A., Inc. v. Zeotec Diamonds, Inc., 2003 U.S. Dist. LEXIS 5595 (C.D. Cal., Mar. 7, 2003) (Lead counsel);{{ FIELD }}Rolex Watch U.S.A., Inc. v. Michel Co., 179 F.3d 704 (9th Cir. 1999);{{ FIELD }}Rolex Watch U.S.A., Inc. v. Meece, 158 F.3d 816 (5th Cir. 1998).{{ FIELD }}Katie McCarthy focuses on trademark, copyright, design, advertising and internet law. As a partner in our Intellectual Property, Patent, Trademark and Copyright Litigation practice, Katie represents clients in a wide array of industries including consumer products, pharmaceuticals, retail, internet services, sports and entertainment, cosmetics, and food and beverages. Katie appears on behalf of clients in federal court and before the U.S. Patent and Trademark Office's Trademark Trial and Appeal Board. Katie also develops domestic and international protection and enforcement programs.\nDuring her more than 30 years of experience, Katie has first-chaired numerous trials and preliminary injunction hearings. Katie actively polices online infringement and scams for several clients. In addition to litigation and contested matters, Katie directs international and domestic trademark clearance and prosecution programs, manages domain name disputes and acquisitions, and develops social media and other intellectual property-related policies.\nKatie also counsels clients on a broad range of IP-related matters, helping to find creative and practical solutions to legal challenges, and developing legal strategies and policies that advance their business goals.\nKatie has served on the Board of the New York Intellectual Property Law Association for years, recently finishing a term as President during which she organized and moderated a forum of key discussion leaders debating online platform liability. Katie served as Editor-in-Chief of the International Trademark Association peer-reviewed scholarly journal, The Trademark Reporter, having served on the committee soliciting and editing articles for the journal for more than 20 years. Katie’s article, “Free Ride or Free Speech: Predicting Results and Providing Advice for Trademark Disputes Involving Parody” won INTA’s 2020 Ladas Memorial Award for best paper in the professional category. Katie has presented at and co-chaired PLI's IP Enforcement Update program annually since 2011 and frequently writes and speaks for PLI, INTA, NYIPLA and other organizations on trademark, copyright and false advertising topics.  Katie is the author of PLI’s one volume treatise, “Kane on Trademark Law: A Practitioner’s Guide.”\nKatie has been recognized in the 2012–2016 editions of Legal 500 for her trademark work. Partner Named as a recommended lawyer for Trademarks: Non-Contentious and Tradmarks: Litigation Legal 500, 2022 Named for Trademark Law Best Lawyers, 2023 Named a Trademark Star nationwide and in New York Managing Intellectual Property, 2022 Ranked for Trademark Law nationwide and in New York World Trademark Review 1000 Named to Managing Intellectual Property’s Global Top 250 Women in IP Managing Intellectual Property, 2020 College of the Holy Cross  Columbia University Columbia University School of Law U.S. Court of Appeals for the Federal Circuit Supreme Court of the United States U.S. Court of Appeals for the Second Circuit U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Eleventh Circuit U.S. Court of Appeals for the D.C. Circuit U.S. District Court for the Eastern District of New York U.S. District Court for the Northern District of New York U.S. District Court for the Southern District of New York New York New York A Better Choice Lock \u0026amp; Key LLC v. Google Inc. et al (DC Cir., filed 2016) (Lead counsel for defendant in Lanham Act, antitrust class action case with CDA Section 230 defense motion to dismiss granted and affirmed on appeal in precedential decision). Baldino’s Lock \u0026amp; Key Inc. v. Google Inc. et al (EDVA and 4th Cir., filed 2014) (Lead counsel for defendant securing CDA Section 230 defense on motion to dismiss in case involving Lanham Act and RICO claims). Valerus Field Solutions LP v. Valerus Specialty Chemicals (SDTX, filed 2015) (Lead counsel for plaintiff in trademark infringement action, securing settlement prior to preliminary injunction motion). On Site Energy Co. v. MTU Onsite Energy (EDNY, filed 2010; jury trial August 2012) (Lead counsel in trademark infringement action challenging the use of the term ON SITE ENERGY in connection with power generators, securing jury verdict for the defense). Spanx, Inc. v. Times Three Clothiers d/b/a Yummie Tummie (NDGA, SDNY, filed 2013) (Lead counsel in design patent infringement declaratory judgment action and related design patent and utility patent infringement action, securing decision invalidating two patents with case resolved and dismissed thereafter). Fritz Hansen A/S v. Restoration Hardware (SDNY, filed 2013) (Lead counsel in trademark and trade dress infringement action involving copies of chair designs, securing resolution). Rolex Watch U.S.A., Inc. v. PRL Holdings (SDNY 2012) (Lead counsel in appeal of TTAB decision involving marks RLX RALPH LAUREN and RALPH LAUREN RLX, securing resolution prior to trial). Prior cases include: Rolex Watch U.S.A., Inc. v. Capetown Diamond Corp. et al (N.D. Georgia 2003-2007) (Lead counsel in the latest of a series of cases establishing that genuine Rolex watches altered with non-genuine integral parts such as diamond bezels and bracelets are counterfeit); Rolex Watch U.S.A., Inc. v. Town \u0026amp; Country Jewelers (2005); Rolex Watch U.S.A., Inc. v. JBJ Distributors, Inc. (5th Cir. July 29, 2003) (per curiam); Rolex Watch U.S.A., Inc. v. Zeotec Diamonds, Inc., 2003 U.S. Dist. LEXIS 5595 (C.D. Cal., Mar. 7, 2003) (Lead counsel); Rolex Watch U.S.A., Inc. v. Michel Co., 179 F.3d 704 (9th Cir. 1999); Rolex Watch U.S.A., Inc. v. Meece, 158 F.3d 816 (5th Cir. 1998).","searchable_name":"Kathleen E. McCarthy (Katie)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null},{"id":446028,"version":1,"owner_type":"Person","owner_id":1169,"payload":{"bio":"\u003cp\u003eZach McEntyre is a crisis-tested litigator. For two decades, he has represented clients in the technology,\u0026nbsp;financial services, insurance, food and beverage, energy, and healthcare industries in their most sensitive class actions, consumer protection matters,\u0026nbsp;and business disputes. He is a leading authority on the defense of high-stakes consumer class actions and \"viral\" litigation and government enforcement action.\u0026nbsp;\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eZach has led the defense in hundreds of class actions\u0026nbsp;and in consumer protection litigation and investigations launched by government actors.\u0026nbsp;His matters almost always implicate core business practices, critical public relations considerations, and federal or state regulatory scrutiny. Zach\u0026nbsp;has defeated class certification or won on the merits in cases asserting claims under the federal and state RICO statutes, California's Unfair Competition Law, New York's GBL sections 349 and 350, the Consumer Fraud Acts in Illinois and New Jersey, and Florida's Deceptive and Unfair Trade Practices Act, among others. He has beaten back claims under the federal Fair Credit Reporting Act (and state analogs), the federal Telephone Consumer Protection Act (and state analogs), the Electronic Communications Privacy Act, the California Information Privacy Act, and every imaginable common-law privacy tort. He has litigated in federal or state courts in nearly every state. Zach's adversaries (and sometimes eventual negotiating partners) have included every leading class action plaintiff's firm, state AGs, activist district attorneys, and federal and state regulators (such as the CFPB and the New York Department of Financial Services).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn addition to his class action practice, Zach handles all manner of commercial disputes.\u0026nbsp;In all of his matters, Zach focuses on working with his clients to identify, right away, the client's business objectives--and then to devise and execute strategies to satisfy those objectives. Those objectives sometimes call for early resolution. Zach is the rare courtroom lawyer who can readily recalibrate from a singular eye for victory in court to a cleareyed assessment of risk and an ability to achieve optimal negotiated outcomes. Whether in the courtroom or across the negotiating table, Zach relies on trial-ready litigation strategy and rock-solid credibility.\u003c/p\u003e\n\u003cp\u003eZach is one of the leaders of the firm's national class action practice and its consumer financial services litigation group. He is a regular author and speaker on cutting-edge litigation issues. He is on the Board of Directors for the Atlanta Volunteers Lawyers Foundation, a former Board member for the Georgia Law Center for the Homeless, and a proud member of the Stonewall Bar\u0026nbsp;Association of Georgia.\u003c/p\u003e","slug":"zachary-mcentyre","email":"zmcentyre@kslaw.com","phone":null,"matters":["\u003cp\u003eObtained voluntary dismissal of lawsuit filed by Alameda County District Attorney against leading automobile insurers and vendors asserting UCL claims relating to claims-adjustment practices (Alameda Cnty. (Calif.) Superior)\u003c/p\u003e","\u003cp\u003eDefending leading global beverage company in putative class action under UCL and FAL regarding allegedly deceptive marketing of milk products (Central District of California)\u003c/p\u003e","\u003cp\u003eDefeated class certification in three putative class actions challenging specific adjustment applied in total-loss valuations on behalf of leading automobile insurer (Southern District of Iowa, Eastern District of North Carolina, District of Arizona)\u003c/p\u003e","\u003cp\u003eWon a groundbreaking victory on summary judgment for a consumer reporting agency in a putative nationwide class action challenging the accuracy of OFAC indicators in purported consumer reports (Eastern District of Pennsylvania)\u003c/p\u003e","\u003cp\u003eOn behalf of insurtech company, defeated class certification in multidefendant putative nationwide class action alleging RICO violations in connection with sales practices (Southern District of California)\u003c/p\u003e","\u003cp\u003eDefeated class certification in long-running putative class action against natural gas supplier alleging violations of Illinois Consumer Fraud Act (Cook Cty. (Ill.) Chancery Court)\u003c/p\u003e","\u003cp\u003eDeployed novel Article III standing argument to defeat class certification on behalf of leading global beverage company in putative nationwide class action alleging violations of Telephone Consumer Protection Act (Southern District of Florida)\u003c/p\u003e","\u003cp\u003eWon pleading-stage dismissal of putative nationwide class action against consumer reporting agency challenging reporting of \"authorized user\" accounts, convincing court plaintiff failed to allege a \"willful\" violation of Fair Credit Reporting Act as a matter of law (Northern District of Georgia)\u003c/p\u003e","\u003cp\u003eWon summary judgment in multidefendant putative nationwide class action challenging accuracy of consumer reporting relating to bankruptcy (Southern District of Indiana)\u003c/p\u003e","\u003cp\u003eWon motions to dismiss in two putative class actions challenging accuracy of consumer reporting relating to COVID-era loan forbearances (Eastern District of New York and District of New Jersey)\u003c/p\u003e","\u003cp\u003eDefeated class certification on behalf of a leading automobile insurer in two putative class actions challenging the accuracy of total-loss valuations (Middle District of Florida and Western District of Oklahoma)\u003c/p\u003e","\u003cp\u003eWon summary judgment for leading automobile insurer in class action relating to salvage vehicle practices (Southern District of Florida)\u003c/p\u003e","\u003cp\u003eWon pleading-stage dismissal of putative nationwide class action against consumer reporting agency alleging violations of \"permissible purpose\" provisions of Fair Credit Reporting Act (Northern District of Georgia)\u003c/p\u003e","\u003cp\u003eWon summary judgment on behalf of consumer reporting agency in putative nationwide class action alleging violations of Fair Credit Reporting Act (Eastern District of Virginia)\u003c/p\u003e","\u003cp\u003eRepresented superregional bank, as replacement counsel, in putative class action asserting breach of contract claims in connection with savings accounts (Eastern District of Tennessee)\u003c/p\u003e","\u003cp\u003eRepresented leading national outdoor retailer in long-running class action challenging assessment of fees in connection with boat sales (Western District of Missouri)\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":74,"guid":"74.capabilities","index":0,"source":"capabilities"},{"id":5,"guid":"5.capabilities","index":1,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":2,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":3,"source":"capabilities"},{"id":106,"guid":"106.capabilities","index":4,"source":"capabilities"},{"id":6,"guid":"6.capabilities","index":5,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":6,"source":"smartTags"},{"id":764,"guid":"764.smart_tags","index":7,"source":"smartTags"},{"id":103,"guid":"103.capabilities","index":8,"source":"capabilities"},{"id":1202,"guid":"1202.smart_tags","index":9,"source":"smartTags"},{"id":1248,"guid":"1248.smart_tags","index":10,"source":"smartTags"},{"id":1243,"guid":"1243.smart_tags","index":11,"source":"smartTags"},{"id":3,"guid":"3.capabilities","index":12,"source":"capabilities"}],"is_active":true,"last_name":"McEntyre","nick_name":"Zach","clerkships":[],"first_name":"Zachary","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":"A.","name_suffix":"","recognitions":[{"title":"Rising Stars","detail":"Consumer Protection - Law 360"},{"title":"40 Under 40—Legal Rising Stars to Watch","detail":"Daily Report"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eZach McEntyre is a crisis-tested litigator. For two decades, he has represented clients in the technology,\u0026nbsp;financial services, insurance, food and beverage, energy, and healthcare industries in their most sensitive class actions, consumer protection matters,\u0026nbsp;and business disputes. He is a leading authority on the defense of high-stakes consumer class actions and \"viral\" litigation and government enforcement action.\u0026nbsp;\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eZach has led the defense in hundreds of class actions\u0026nbsp;and in consumer protection litigation and investigations launched by government actors.\u0026nbsp;His matters almost always implicate core business practices, critical public relations considerations, and federal or state regulatory scrutiny. Zach\u0026nbsp;has defeated class certification or won on the merits in cases asserting claims under the federal and state RICO statutes, California's Unfair Competition Law, New York's GBL sections 349 and 350, the Consumer Fraud Acts in Illinois and New Jersey, and Florida's Deceptive and Unfair Trade Practices Act, among others. He has beaten back claims under the federal Fair Credit Reporting Act (and state analogs), the federal Telephone Consumer Protection Act (and state analogs), the Electronic Communications Privacy Act, the California Information Privacy Act, and every imaginable common-law privacy tort. He has litigated in federal or state courts in nearly every state. Zach's adversaries (and sometimes eventual negotiating partners) have included every leading class action plaintiff's firm, state AGs, activist district attorneys, and federal and state regulators (such as the CFPB and the New York Department of Financial Services).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn addition to his class action practice, Zach handles all manner of commercial disputes.\u0026nbsp;In all of his matters, Zach focuses on working with his clients to identify, right away, the client's business objectives--and then to devise and execute strategies to satisfy those objectives. Those objectives sometimes call for early resolution. Zach is the rare courtroom lawyer who can readily recalibrate from a singular eye for victory in court to a cleareyed assessment of risk and an ability to achieve optimal negotiated outcomes. Whether in the courtroom or across the negotiating table, Zach relies on trial-ready litigation strategy and rock-solid credibility.\u003c/p\u003e\n\u003cp\u003eZach is one of the leaders of the firm's national class action practice and its consumer financial services litigation group. He is a regular author and speaker on cutting-edge litigation issues. He is on the Board of Directors for the Atlanta Volunteers Lawyers Foundation, a former Board member for the Georgia Law Center for the Homeless, and a proud member of the Stonewall Bar\u0026nbsp;Association of Georgia.\u003c/p\u003e","matters":["\u003cp\u003eObtained voluntary dismissal of lawsuit filed by Alameda County District Attorney against leading automobile insurers and vendors asserting UCL claims relating to claims-adjustment practices (Alameda Cnty. (Calif.) Superior)\u003c/p\u003e","\u003cp\u003eDefending leading global beverage company in putative class action under UCL and FAL regarding allegedly deceptive marketing of milk products (Central District of California)\u003c/p\u003e","\u003cp\u003eDefeated class certification in three putative class actions challenging specific adjustment applied in total-loss valuations on behalf of leading automobile insurer (Southern District of Iowa, Eastern District of North Carolina, District of Arizona)\u003c/p\u003e","\u003cp\u003eWon a groundbreaking victory on summary judgment for a consumer reporting agency in a putative nationwide class action challenging the accuracy of OFAC indicators in purported consumer reports (Eastern District of Pennsylvania)\u003c/p\u003e","\u003cp\u003eOn behalf of insurtech company, defeated class certification in multidefendant putative nationwide class action alleging RICO violations in connection with sales practices (Southern District of California)\u003c/p\u003e","\u003cp\u003eDefeated class certification in long-running putative class action against natural gas supplier alleging violations of Illinois Consumer Fraud Act (Cook Cty. (Ill.) Chancery Court)\u003c/p\u003e","\u003cp\u003eDeployed novel Article III standing argument to defeat class certification on behalf of leading global beverage company in putative nationwide class action alleging violations of Telephone Consumer Protection Act (Southern District of Florida)\u003c/p\u003e","\u003cp\u003eWon pleading-stage dismissal of putative nationwide class action against consumer reporting agency challenging reporting of \"authorized user\" accounts, convincing court plaintiff failed to allege a \"willful\" violation of Fair Credit Reporting Act as a matter of law (Northern District of Georgia)\u003c/p\u003e","\u003cp\u003eWon summary judgment in multidefendant putative nationwide class action challenging accuracy of consumer reporting relating to bankruptcy (Southern District of Indiana)\u003c/p\u003e","\u003cp\u003eWon motions to dismiss in two putative class actions challenging accuracy of consumer reporting relating to COVID-era loan forbearances (Eastern District of New York and District of New Jersey)\u003c/p\u003e","\u003cp\u003eDefeated class certification on behalf of a leading automobile insurer in two putative class actions challenging the accuracy of total-loss valuations (Middle District of Florida and Western District of Oklahoma)\u003c/p\u003e","\u003cp\u003eWon summary judgment for leading automobile insurer in class action relating to salvage vehicle practices (Southern District of Florida)\u003c/p\u003e","\u003cp\u003eWon pleading-stage dismissal of putative nationwide class action against consumer reporting agency alleging violations of \"permissible purpose\" provisions of Fair Credit Reporting Act (Northern District of Georgia)\u003c/p\u003e","\u003cp\u003eWon summary judgment on behalf of consumer reporting agency in putative nationwide class action alleging violations of Fair Credit Reporting Act (Eastern District of Virginia)\u003c/p\u003e","\u003cp\u003eRepresented superregional bank, as replacement counsel, in putative class action asserting breach of contract claims in connection with savings accounts (Eastern District of Tennessee)\u003c/p\u003e","\u003cp\u003eRepresented leading national outdoor retailer in long-running class action challenging assessment of fees in connection with boat sales (Western District of Missouri)\u003c/p\u003e"],"recognitions":[{"title":"Rising Stars","detail":"Consumer Protection - Law 360"},{"title":"40 Under 40—Legal Rising Stars to Watch","detail":"Daily Report"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1051}]},"capability_group_id":3},"created_at":"2026-02-23T17:10:39.000Z","updated_at":"2026-02-23T17:10:39.000Z","searchable_text":"McEntyre{{ FIELD }}{:title=\u0026gt;\"Rising Stars\", :detail=\u0026gt;\"Consumer Protection - Law 360\"}{{ FIELD }}{:title=\u0026gt;\"40 Under 40—Legal Rising Stars to Watch\", :detail=\u0026gt;\"Daily Report\"}{{ FIELD }}Obtained voluntary dismissal of lawsuit filed by Alameda County District Attorney against leading automobile insurers and vendors asserting UCL claims relating to claims-adjustment practices (Alameda Cnty. (Calif.) Superior){{ FIELD }}Defending leading global beverage company in putative class action under UCL and FAL regarding allegedly deceptive marketing of milk products (Central District of California){{ FIELD }}Defeated class certification in three putative class actions challenging specific adjustment applied in total-loss valuations on behalf of leading automobile insurer (Southern District of Iowa, Eastern District of North Carolina, District of Arizona){{ FIELD }}Won a groundbreaking victory on summary judgment for a consumer reporting agency in a putative nationwide class action challenging the accuracy of OFAC indicators in purported consumer reports (Eastern District of Pennsylvania){{ FIELD }}On behalf of insurtech company, defeated class certification in multidefendant putative nationwide class action alleging RICO violations in connection with sales practices (Southern District of California){{ FIELD }}Defeated class certification in long-running putative class action against natural gas supplier alleging violations of Illinois Consumer Fraud Act (Cook Cty. (Ill.) Chancery Court){{ FIELD }}Deployed novel Article III standing argument to defeat class certification on behalf of leading global beverage company in putative nationwide class action alleging violations of Telephone Consumer Protection Act (Southern District of Florida){{ FIELD }}Won pleading-stage dismissal of putative nationwide class action against consumer reporting agency challenging reporting of \"authorized user\" accounts, convincing court plaintiff failed to allege a \"willful\" violation of Fair Credit Reporting Act as a matter of law (Northern District of Georgia){{ FIELD }}Won summary judgment in multidefendant putative nationwide class action challenging accuracy of consumer reporting relating to bankruptcy (Southern District of Indiana){{ FIELD }}Won motions to dismiss in two putative class actions challenging accuracy of consumer reporting relating to COVID-era loan forbearances (Eastern District of New York and District of New Jersey){{ FIELD }}Defeated class certification on behalf of a leading automobile insurer in two putative class actions challenging the accuracy of total-loss valuations (Middle District of Florida and Western District of Oklahoma){{ FIELD }}Won summary judgment for leading automobile insurer in class action relating to salvage vehicle practices (Southern District of Florida){{ FIELD }}Won pleading-stage dismissal of putative nationwide class action against consumer reporting agency alleging violations of \"permissible purpose\" provisions of Fair Credit Reporting Act (Northern District of Georgia){{ FIELD }}Won summary judgment on behalf of consumer reporting agency in putative nationwide class action alleging violations of Fair Credit Reporting Act (Eastern District of Virginia){{ FIELD }}Represented superregional bank, as replacement counsel, in putative class action asserting breach of contract claims in connection with savings accounts (Eastern District of Tennessee){{ FIELD }}Represented leading national outdoor retailer in long-running class action challenging assessment of fees in connection with boat sales (Western District of Missouri){{ FIELD }}Zach McEntyre is a crisis-tested litigator. For two decades, he has represented clients in the technology, financial services, insurance, food and beverage, energy, and healthcare industries in their most sensitive class actions, consumer protection matters, and business disputes. He is a leading authority on the defense of high-stakes consumer class actions and \"viral\" litigation and government enforcement action.  \nZach has led the defense in hundreds of class actions and in consumer protection litigation and investigations launched by government actors. His matters almost always implicate core business practices, critical public relations considerations, and federal or state regulatory scrutiny. Zach has defeated class certification or won on the merits in cases asserting claims under the federal and state RICO statutes, California's Unfair Competition Law, New York's GBL sections 349 and 350, the Consumer Fraud Acts in Illinois and New Jersey, and Florida's Deceptive and Unfair Trade Practices Act, among others. He has beaten back claims under the federal Fair Credit Reporting Act (and state analogs), the federal Telephone Consumer Protection Act (and state analogs), the Electronic Communications Privacy Act, the California Information Privacy Act, and every imaginable common-law privacy tort. He has litigated in federal or state courts in nearly every state. Zach's adversaries (and sometimes eventual negotiating partners) have included every leading class action plaintiff's firm, state AGs, activist district attorneys, and federal and state regulators (such as the CFPB and the New York Department of Financial Services). \nIn addition to his class action practice, Zach handles all manner of commercial disputes. In all of his matters, Zach focuses on working with his clients to identify, right away, the client's business objectives--and then to devise and execute strategies to satisfy those objectives. Those objectives sometimes call for early resolution. Zach is the rare courtroom lawyer who can readily recalibrate from a singular eye for victory in court to a cleareyed assessment of risk and an ability to achieve optimal negotiated outcomes. Whether in the courtroom or across the negotiating table, Zach relies on trial-ready litigation strategy and rock-solid credibility.\nZach is one of the leaders of the firm's national class action practice and its consumer financial services litigation group. He is a regular author and speaker on cutting-edge litigation issues. He is on the Board of Directors for the Atlanta Volunteers Lawyers Foundation, a former Board member for the Georgia Law Center for the Homeless, and a proud member of the Stonewall Bar Association of Georgia. Partner Rising Stars Consumer Protection - Law 360 40 Under 40—Legal Rising Stars to Watch Daily Report University of Georgia University of Georgia School of Law Mercer University Mercer University Walter F. George School of Law U.S. Court of Appeals for the Fourth Circuit U.S. Court of Appeals for the Fifth Circuit U.S. Court of Appeals for the Seventh Circuit U.S. Court of Appeals for the Ninth Circuit U.S. Court of Appeals for the Tenth Circuit U.S. Court of Appeals for the Eleventh Circuit U.S. District Court for the Eastern District of Michigan U.S. District Court for the Eastern District of Wisconsin U.S. District Court for the Northern District of Florida U.S. District Court for the Northern District of Georgia Georgia Obtained voluntary dismissal of lawsuit filed by Alameda County District Attorney against leading automobile insurers and vendors asserting UCL claims relating to claims-adjustment practices (Alameda Cnty. (Calif.) Superior) Defending leading global beverage company in putative class action under UCL and FAL regarding allegedly deceptive marketing of milk products (Central District of California) Defeated class certification in three putative class actions challenging specific adjustment applied in total-loss valuations on behalf of leading automobile insurer (Southern District of Iowa, Eastern District of North Carolina, District of Arizona) Won a groundbreaking victory on summary judgment for a consumer reporting agency in a putative nationwide class action challenging the accuracy of OFAC indicators in purported consumer reports (Eastern District of Pennsylvania) On behalf of insurtech company, defeated class certification in multidefendant putative nationwide class action alleging RICO violations in connection with sales practices (Southern District of California) Defeated class certification in long-running putative class action against natural gas supplier alleging violations of Illinois Consumer Fraud Act (Cook Cty. (Ill.) Chancery Court) Deployed novel Article III standing argument to defeat class certification on behalf of leading global beverage company in putative nationwide class action alleging violations of Telephone Consumer Protection Act (Southern District of Florida) Won pleading-stage dismissal of putative nationwide class action against consumer reporting agency challenging reporting of \"authorized user\" accounts, convincing court plaintiff failed to allege a \"willful\" violation of Fair Credit Reporting Act as a matter of law (Northern District of Georgia) Won summary judgment in multidefendant putative nationwide class action challenging accuracy of consumer reporting relating to bankruptcy (Southern District of Indiana) Won motions to dismiss in two putative class actions challenging accuracy of consumer reporting relating to COVID-era loan forbearances (Eastern District of New York and District of New Jersey) Defeated class certification on behalf of a leading automobile insurer in two putative class actions challenging the accuracy of total-loss valuations (Middle District of Florida and Western District of Oklahoma) Won summary judgment for leading automobile insurer in class action relating to salvage vehicle practices (Southern District of Florida) Won pleading-stage dismissal of putative nationwide class action against consumer reporting agency alleging violations of \"permissible purpose\" provisions of Fair Credit Reporting Act (Northern District of Georgia) Won summary judgment on behalf of consumer reporting agency in putative nationwide class action alleging violations of Fair Credit Reporting Act (Eastern District of Virginia) Represented superregional bank, as replacement counsel, in putative class action asserting breach of contract claims in connection with savings accounts (Eastern District of Tennessee) Represented leading national outdoor retailer in long-running class action challenging assessment of fees in connection with boat sales (Western District of Missouri)","searchable_name":"Zachary A. McEntyre (Zach)","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":426677,"version":1,"owner_type":"Person","owner_id":5427,"payload":{"bio":"\u003cp\u003eDerek Meilman is the lawyer of choice for complex transatlantic mergers, acquisitions and strategic joint ventures which require a nuanced engagement with government bodies and state actors, whether as regulators, investors, sponsors, legislators or otherwise. Qualified as an attorney in New York State and as a solicitor in England \u0026amp; Wales and the Republic of Ireland, Derek\u0026rsquo;s clients include major multinational companies, private equity groups, governments (including sovereign wealth funds and multilateral organizations) and family offices.\u0026nbsp;Derek has a BA from Brown University and a JD from the Duke University School of Law. In addition to his law practice, Derek serves as a non-executive director on the board of CA Ron Santa Teresa, the Caracas stock exchange-listed producer of the award-winning \u0026lsquo;Santa Teresa 1796\u0026rsquo; solera method rum.\u003c/p\u003e","slug":"derek-meilman","email":"dmeilman@kslaw.com","phone":"+44 759 000 3654","matters":["\u003cp\u003eRepresented Francisco Partners portfolio company Keyloop in connection with its acquisition of 100% of the shares of Automotive Transformation Group from Inflexion Private Equity\u003c/p\u003e","\u003cp\u003eRepresented the Aydin Group of Turkiye (the owner of A101, English Home, Eve and Memorial Healthcare Group) on the sale to the Dubai Islamic Bank of a minority stake in the T.O.M. Group, a digital banking and financial technology business\u003c/p\u003e","\u003cp\u003eRepresented Afendis Capital Management in connection with the acquisition by Afendis and Davidson Kempner Capital Management of 100% of Gelato d\u0026rsquo;Italia, the leading independent ice-cream producer in Italy\u003c/p\u003e","\u003cp\u003eRepresented Afendis Capital Management in connection with the acquisition, in the context of a complex restructuring, by Afendis and Davidson Kempner Capital Management of a controlling interest in Cerealto Siro Foods, a Spanish co-manufacturer and private-label producer of cookies, cereals and pasta\u003c/p\u003e","\u003cp\u003eRepresented Afendis Capital Partners as transaction sponsor in connection with the acquisition by a private equity consortium, including Afendis and Metric Capital Partners, of a 30% stake in Turkish generic drug maker Sanovel\u003c/p\u003e","\u003cp\u003eRepresented Olivier Creed in the sale of Creed fragrances, one of the world\u0026rsquo;s leading luxury perfume houses, to BlackRock Long Term Private Capital, a perpetual capital private equity fund within the world\u0026rsquo;s largest asset manager, and Javier Ferr\u0026aacute;n, Chairman of Diageo\u003c/p\u003e","\u003cp\u003eRepresented Ron Santa Teresa of Venezuela in connection with an international distribution alliance with Bacardi, the world's largest privately owned spirits company\u003c/p\u003e","\u003cp\u003eRepresented WSP Global in connection with the acquisition for US$1.31bn of Parsons Brinckerhoff from infrastructure group Balfour Beatty\u003c/p\u003e","\u003cp\u003eRepresented the senior noteholders of Ukrainian agricultural company Mriya in the restructuring which resulted in ownership of the company by its former creditors and then the onward sale of the Mriya business to the Saudi Agricultural \u0026amp; Livestock Investment Company\u003c/p\u003e","\u003cp\u003eRepresented Global Solar Energy, a manufacturer of flexible solar technology, on its sale to the Hanergy Group of China\u003c/p\u003e","\u003cp\u003eRepresented Colombian financial services firm Grupo Sura in connection with its buyout of JP Morgan, General Atlantic and IFC interests in Sura Asset Management\u003c/p\u003e","\u003cp\u003eRepresented NorthStar Realty Europe and China Resources Land on acquisition from AXA Investment Managers of 20 Gresham St., a trophy office building in the City of London\u003c/p\u003e","\u003cp\u003eRepresented Colony Capital in connection with the acquisition of an interest in the Fibonacci Square development project in Ballsbridge, Dublin and related arrangements among partners\u003c/p\u003e","\u003cp\u003eRepresented Metsanco Ltd and its affiliates in the sale of Olo de Peru and TVS Wireless to a subsidiary of America Movil, the Mexican telecom\u003c/p\u003e","\u003cp\u003eRepresented LeapFrog Investments, which invests in businesses in Africa and Asia, in connection with multiple M\u0026amp;A transactions\u003c/p\u003e","\u003cp\u003eRepresented Kodak Pension Plan (KPP) in connection with its acquisition of Kodak Alaris in settlement of KPP's claim in the Eastman Kodak bankruptcy\u003c/p\u003e","\u003cp\u003eRepresented Quantum Pacific Exploration in connection with a strategic partnership with Barrick Gold to explore for and develop copper deposits in Chile\u003c/p\u003e","\u003cp\u003eRepresented The Gores Group in its acquisition of a majority stake in Mexx International from Liz Claiborne, including the formation of a related joint venture\u003c/p\u003e","\u003cp\u003eRepresented marine transportation services company American Commercial Lines in connection with its US$800m \u0026lsquo;going private\u0026rsquo; sale to Platinum Equity\u003c/p\u003e","\u003cp\u003eRepresented an American subsidiary of a European aerospace and defense company in its disposition of an entity under a proxy agreement with the US Department of Defense\u003c/p\u003e","\u003cp\u003eRepresented NBCUniversal in connection with its sale of Los Angeles-based Spanish-language television station KWHY-TV to Meruelo Enterprises\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":75,"guid":"75.capabilities","index":0,"source":"capabilities"},{"id":32,"guid":"32.capabilities","index":1,"source":"capabilities"},{"id":33,"guid":"33.capabilities","index":2,"source":"capabilities"},{"id":27,"guid":"27.capabilities","index":3,"source":"capabilities"},{"id":80,"guid":"80.capabilities","index":4,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":5,"source":"capabilities"},{"id":110,"guid":"110.capabilities","index":6,"source":"capabilities"},{"id":102,"guid":"102.capabilities","index":7,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":8,"source":"capabilities"},{"id":104,"guid":"104.capabilities","index":9,"source":"capabilities"},{"id":126,"guid":"126.capabilities","index":10,"source":"capabilities"},{"id":1220,"guid":"1220.smart_tags","index":11,"source":"smartTags"},{"id":128,"guid":"128.capabilities","index":12,"source":"capabilities"},{"id":1261,"guid":"1261.smart_tags","index":13,"source":"smartTags"}],"is_active":true,"last_name":"Meilman","nick_name":"Derek","clerkships":[],"first_name":"Derek","title_rank":9999,"updated_by":35,"law_schools":[{"id":613,"meta":{"degree":"J.D.","honors":null,"is_law_school":1,"graduation_date":"2002-01-01 00:00:00 UTC"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":"","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eDerek Meilman is the lawyer of choice for complex transatlantic mergers, acquisitions and strategic joint ventures which require a nuanced engagement with government bodies and state actors, whether as regulators, investors, sponsors, legislators or otherwise. Qualified as an attorney in New York State and as a solicitor in England \u0026amp; Wales and the Republic of Ireland, Derek\u0026rsquo;s clients include major multinational companies, private equity groups, governments (including sovereign wealth funds and multilateral organizations) and family offices.\u0026nbsp;Derek has a BA from Brown University and a JD from the Duke University School of Law. In addition to his law practice, Derek serves as a non-executive director on the board of CA Ron Santa Teresa, the Caracas stock exchange-listed producer of the award-winning \u0026lsquo;Santa Teresa 1796\u0026rsquo; solera method rum.\u003c/p\u003e","matters":["\u003cp\u003eRepresented Francisco Partners portfolio company Keyloop in connection with its acquisition of 100% of the shares of Automotive Transformation Group from Inflexion Private Equity\u003c/p\u003e","\u003cp\u003eRepresented the Aydin Group of Turkiye (the owner of A101, English Home, Eve and Memorial Healthcare Group) on the sale to the Dubai Islamic Bank of a minority stake in the T.O.M. Group, a digital banking and financial technology business\u003c/p\u003e","\u003cp\u003eRepresented Afendis Capital Management in connection with the acquisition by Afendis and Davidson Kempner Capital Management of 100% of Gelato d\u0026rsquo;Italia, the leading independent ice-cream producer in Italy\u003c/p\u003e","\u003cp\u003eRepresented Afendis Capital Management in connection with the acquisition, in the context of a complex restructuring, by Afendis and Davidson Kempner Capital Management of a controlling interest in Cerealto Siro Foods, a Spanish co-manufacturer and private-label producer of cookies, cereals and pasta\u003c/p\u003e","\u003cp\u003eRepresented Afendis Capital Partners as transaction sponsor in connection with the acquisition by a private equity consortium, including Afendis and Metric Capital Partners, of a 30% stake in Turkish generic drug maker Sanovel\u003c/p\u003e","\u003cp\u003eRepresented Olivier Creed in the sale of Creed fragrances, one of the world\u0026rsquo;s leading luxury perfume houses, to BlackRock Long Term Private Capital, a perpetual capital private equity fund within the world\u0026rsquo;s largest asset manager, and Javier Ferr\u0026aacute;n, Chairman of Diageo\u003c/p\u003e","\u003cp\u003eRepresented Ron Santa Teresa of Venezuela in connection with an international distribution alliance with Bacardi, the world's largest privately owned spirits company\u003c/p\u003e","\u003cp\u003eRepresented WSP Global in connection with the acquisition for US$1.31bn of Parsons Brinckerhoff from infrastructure group Balfour Beatty\u003c/p\u003e","\u003cp\u003eRepresented the senior noteholders of Ukrainian agricultural company Mriya in the restructuring which resulted in ownership of the company by its former creditors and then the onward sale of the Mriya business to the Saudi Agricultural \u0026amp; Livestock Investment Company\u003c/p\u003e","\u003cp\u003eRepresented Global Solar Energy, a manufacturer of flexible solar technology, on its sale to the Hanergy Group of China\u003c/p\u003e","\u003cp\u003eRepresented Colombian financial services firm Grupo Sura in connection with its buyout of JP Morgan, General Atlantic and IFC interests in Sura Asset Management\u003c/p\u003e","\u003cp\u003eRepresented NorthStar Realty Europe and China Resources Land on acquisition from AXA Investment Managers of 20 Gresham St., a trophy office building in the City of London\u003c/p\u003e","\u003cp\u003eRepresented Colony Capital in connection with the acquisition of an interest in the Fibonacci Square development project in Ballsbridge, Dublin and related arrangements among partners\u003c/p\u003e","\u003cp\u003eRepresented Metsanco Ltd and its affiliates in the sale of Olo de Peru and TVS Wireless to a subsidiary of America Movil, the Mexican telecom\u003c/p\u003e","\u003cp\u003eRepresented LeapFrog Investments, which invests in businesses in Africa and Asia, in connection with multiple M\u0026amp;A transactions\u003c/p\u003e","\u003cp\u003eRepresented Kodak Pension Plan (KPP) in connection with its acquisition of Kodak Alaris in settlement of KPP's claim in the Eastman Kodak bankruptcy\u003c/p\u003e","\u003cp\u003eRepresented Quantum Pacific Exploration in connection with a strategic partnership with Barrick Gold to explore for and develop copper deposits in Chile\u003c/p\u003e","\u003cp\u003eRepresented The Gores Group in its acquisition of a majority stake in Mexx International from Liz Claiborne, including the formation of a related joint venture\u003c/p\u003e","\u003cp\u003eRepresented marine transportation services company American Commercial Lines in connection with its US$800m \u0026lsquo;going private\u0026rsquo; sale to Platinum Equity\u003c/p\u003e","\u003cp\u003eRepresented an American subsidiary of a European aerospace and defense company in its disposition of an entity under a proxy agreement with the US Department of Defense\u003c/p\u003e","\u003cp\u003eRepresented NBCUniversal in connection with its sale of Los Angeles-based Spanish-language television station KWHY-TV to Meruelo Enterprises\u003c/p\u003e"]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":9172}]},"capability_group_id":1},"created_at":"2025-05-26T04:55:56.000Z","updated_at":"2025-05-26T04:55:56.000Z","searchable_text":"Meilman{{ FIELD }}Represented Francisco Partners portfolio company Keyloop in connection with its acquisition of 100% of the shares of Automotive Transformation Group from Inflexion Private Equity{{ FIELD }}Represented the Aydin Group of Turkiye (the owner of A101, English Home, Eve and Memorial Healthcare Group) on the sale to the Dubai Islamic Bank of a minority stake in the T.O.M. Group, a digital banking and financial technology business{{ FIELD }}Represented Afendis Capital Management in connection with the acquisition by Afendis and Davidson Kempner Capital Management of 100% of Gelato d’Italia, the leading independent ice-cream producer in Italy{{ FIELD }}Represented Afendis Capital Management in connection with the acquisition, in the context of a complex restructuring, by Afendis and Davidson Kempner Capital Management of a controlling interest in Cerealto Siro Foods, a Spanish co-manufacturer and private-label producer of cookies, cereals and pasta{{ FIELD }}Represented Afendis Capital Partners as transaction sponsor in connection with the acquisition by a private equity consortium, including Afendis and Metric Capital Partners, of a 30% stake in Turkish generic drug maker Sanovel{{ FIELD }}Represented Olivier Creed in the sale of Creed fragrances, one of the world’s leading luxury perfume houses, to BlackRock Long Term Private Capital, a perpetual capital private equity fund within the world’s largest asset manager, and Javier Ferrán, Chairman of Diageo{{ FIELD }}Represented Ron Santa Teresa of Venezuela in connection with an international distribution alliance with Bacardi, the world's largest privately owned spirits company{{ FIELD }}Represented WSP Global in connection with the acquisition for US$1.31bn of Parsons Brinckerhoff from infrastructure group Balfour Beatty{{ FIELD }}Represented the senior noteholders of Ukrainian agricultural company Mriya in the restructuring which resulted in ownership of the company by its former creditors and then the onward sale of the Mriya business to the Saudi Agricultural \u0026amp; Livestock Investment Company{{ FIELD }}Represented Global Solar Energy, a manufacturer of flexible solar technology, on its sale to the Hanergy Group of China{{ FIELD }}Represented Colombian financial services firm Grupo Sura in connection with its buyout of JP Morgan, General Atlantic and IFC interests in Sura Asset Management{{ FIELD }}Represented NorthStar Realty Europe and China Resources Land on acquisition from AXA Investment Managers of 20 Gresham St., a trophy office building in the City of London{{ FIELD }}Represented Colony Capital in connection with the acquisition of an interest in the Fibonacci Square development project in Ballsbridge, Dublin and related arrangements among partners{{ FIELD }}Represented Metsanco Ltd and its affiliates in the sale of Olo de Peru and TVS Wireless to a subsidiary of America Movil, the Mexican telecom{{ FIELD }}Represented LeapFrog Investments, which invests in businesses in Africa and Asia, in connection with multiple M\u0026amp;A transactions{{ FIELD }}Represented Kodak Pension Plan (KPP) in connection with its acquisition of Kodak Alaris in settlement of KPP's claim in the Eastman Kodak bankruptcy{{ FIELD }}Represented Quantum Pacific Exploration in connection with a strategic partnership with Barrick Gold to explore for and develop copper deposits in Chile{{ FIELD }}Represented The Gores Group in its acquisition of a majority stake in Mexx International from Liz Claiborne, including the formation of a related joint venture{{ FIELD }}Represented marine transportation services company American Commercial Lines in connection with its US$800m ‘going private’ sale to Platinum Equity{{ FIELD }}Represented an American subsidiary of a European aerospace and defense company in its disposition of an entity under a proxy agreement with the US Department of Defense{{ FIELD }}Represented NBCUniversal in connection with its sale of Los Angeles-based Spanish-language television station KWHY-TV to Meruelo Enterprises{{ FIELD }}Derek Meilman is the lawyer of choice for complex transatlantic mergers, acquisitions and strategic joint ventures which require a nuanced engagement with government bodies and state actors, whether as regulators, investors, sponsors, legislators or otherwise. Qualified as an attorney in New York State and as a solicitor in England \u0026amp; Wales and the Republic of Ireland, Derek’s clients include major multinational companies, private equity groups, governments (including sovereign wealth funds and multilateral organizations) and family offices. Derek has a BA from Brown University and a JD from the Duke University School of Law. In addition to his law practice, Derek serves as a non-executive director on the board of CA Ron Santa Teresa, the Caracas stock exchange-listed producer of the award-winning ‘Santa Teresa 1796’ solera method rum. Partner Brown University  Financial Times  Duke University Duke University School of Law New York England and Wales Ireland Represented Francisco Partners portfolio company Keyloop in connection with its acquisition of 100% of the shares of Automotive Transformation Group from Inflexion Private Equity Represented the Aydin Group of Turkiye (the owner of A101, English Home, Eve and Memorial Healthcare Group) on the sale to the Dubai Islamic Bank of a minority stake in the T.O.M. Group, a digital banking and financial technology business Represented Afendis Capital Management in connection with the acquisition by Afendis and Davidson Kempner Capital Management of 100% of Gelato d’Italia, the leading independent ice-cream producer in Italy Represented Afendis Capital Management in connection with the acquisition, in the context of a complex restructuring, by Afendis and Davidson Kempner Capital Management of a controlling interest in Cerealto Siro Foods, a Spanish co-manufacturer and private-label producer of cookies, cereals and pasta Represented Afendis Capital Partners as transaction sponsor in connection with the acquisition by a private equity consortium, including Afendis and Metric Capital Partners, of a 30% stake in Turkish generic drug maker Sanovel Represented Olivier Creed in the sale of Creed fragrances, one of the world’s leading luxury perfume houses, to BlackRock Long Term Private Capital, a perpetual capital private equity fund within the world’s largest asset manager, and Javier Ferrán, Chairman of Diageo Represented Ron Santa Teresa of Venezuela in connection with an international distribution alliance with Bacardi, the world's largest privately owned spirits company Represented WSP Global in connection with the acquisition for US$1.31bn of Parsons Brinckerhoff from infrastructure group Balfour Beatty Represented the senior noteholders of Ukrainian agricultural company Mriya in the restructuring which resulted in ownership of the company by its former creditors and then the onward sale of the Mriya business to the Saudi Agricultural \u0026amp; Livestock Investment Company Represented Global Solar Energy, a manufacturer of flexible solar technology, on its sale to the Hanergy Group of China Represented Colombian financial services firm Grupo Sura in connection with its buyout of JP Morgan, General Atlantic and IFC interests in Sura Asset Management Represented NorthStar Realty Europe and China Resources Land on acquisition from AXA Investment Managers of 20 Gresham St., a trophy office building in the City of London Represented Colony Capital in connection with the acquisition of an interest in the Fibonacci Square development project in Ballsbridge, Dublin and related arrangements among partners Represented Metsanco Ltd and its affiliates in the sale of Olo de Peru and TVS Wireless to a subsidiary of America Movil, the Mexican telecom Represented LeapFrog Investments, which invests in businesses in Africa and Asia, in connection with multiple M\u0026amp;A transactions Represented Kodak Pension Plan (KPP) in connection with its acquisition of Kodak Alaris in settlement of KPP's claim in the Eastman Kodak bankruptcy Represented Quantum Pacific Exploration in connection with a strategic partnership with Barrick Gold to explore for and develop copper deposits in Chile Represented The Gores Group in its acquisition of a majority stake in Mexx International from Liz Claiborne, including the formation of a related joint venture Represented marine transportation services company American Commercial Lines in connection with its US$800m ‘going private’ sale to Platinum Equity Represented an American subsidiary of a European aerospace and defense company in its disposition of an entity under a proxy agreement with the US Department of Defense Represented NBCUniversal in connection with its sale of Los Angeles-based Spanish-language television station KWHY-TV to Meruelo Enterprises","searchable_name":"Derek Meilman","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":35,"capability_group_featured":null,"home_page_featured":null},{"id":442801,"version":1,"owner_type":"Person","owner_id":5630,"payload":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","slug":"genevieve-michaux","email":"gmichaux@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":17,"guid":"17.capabilities","index":1,"source":"capabilities"},{"id":13,"guid":"13.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":105,"guid":"105.capabilities","index":5,"source":"capabilities"},{"id":780,"guid":"780.smart_tags","index":6,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":7,"source":"smartTags"},{"id":970,"guid":"970.smart_tags","index":8,"source":"smartTags"},{"id":112,"guid":"112.capabilities","index":9,"source":"capabilities"},{"id":114,"guid":"114.capabilities","index":10,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":11,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":12,"source":"smartTags"},{"id":128,"guid":"128.capabilities","index":13,"source":"capabilities"}],"is_active":true,"last_name":"Michaux","nick_name":"Geneviève","clerkships":[],"first_name":"Geneviève","title_rank":9999,"updated_by":101,"law_schools":[{"id":824,"meta":{"degree":"Law Degree","honors":null,"is_law_school":1,"graduation_date":"1996-01-01 00:00:00 UTC"},"order":0,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}],"linked_in_url":"https://www.linkedin.com/in/geneviève-michaux-165829/","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eGenevi\u0026egrave;ve Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\u003c/p\u003e\n\u003cp\u003eRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Genevi\u0026egrave;ve assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve\u0026rsquo;s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\u003c/p\u003e\n\u003cp\u003eShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\u003c/p\u003e\n\u003cp\u003eGenevi\u0026egrave;ve is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePublications\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eOctober 2019, \u0026ldquo;Are the paediatric rewards adapted? \u0026ldquo;, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\u003c/li\u003e\n\u003cli\u003eMay 30, 2019, \u0026ldquo;The regulation of advanced therapy medicinal products\u0026rdquo;\u0026nbsp;\u003cem\u003eLexisNexis.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2017, \u0026ldquo;Pediatric Regulation \u0026ndash; A Better application for more efficient incentives,\u0026rdquo;\u0026nbsp;\u003cem\u003eThe European Files, Medicines of the Future.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eSeptember 2016, \u0026ldquo;Should Anthroposophic Medicinal Products Be Regulated in Europe?\u0026rdquo;\u0026nbsp;\u003cem\u003eJournal of European Health Law\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eJune 8, 2016, \u0026ldquo;Demonstrating Significant Benefit For Orphan Medicines \u0026ndash; Is It Time For A Drastic Change?\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;EU Pediatric Rewards \u0026ndash; More Questions than Answers,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003cli\u003eFebruary 2016, \u0026ldquo;The Need For Clarification On Post-Market Requirements For Pediatric Medicines,\u0026rdquo;\u0026nbsp;\u003cem\u003eScrip Regulatory Affairs.\u003c/em\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eSpeaking Engagements\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003eSeptember 9, 2019, \u0026ldquo;\u003cem\u003eSummary of Key EUCJ Decisions\u003c/em\u003e,\u0026rdquo; European Pharmaceutical Law Academy.\u003c/li\u003e\n\u003cli\u003eJune 5, 2019, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eSeptember 10, 2018, \u0026ldquo;ATMP Regulatory Framework\u003cem\u003e,\u0026rdquo;\u0026nbsp;\u003c/em\u003eEuropean Pharmaceutical Law Academy, Cambridge, UK.\u003c/li\u003e\n\u003cli\u003eJune 2018, \u0026ldquo;Approval Process for Drugs and Medical Devices,\u0026rdquo; European Healthcare Industry Training: Compliance Certificate Program.\u003c/li\u003e\n\u003cli\u003eMay 15, 2018, \u0026ldquo;International Labeling Regulatory Requirements,\u0026rdquo; co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\u003c/li\u003e\n\u003cli\u003eMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\u003c/li\u003e\n\u003cli\u003eMarch 2018, ATMPs \u0026ndash; Challenges and Promises, ERA, EU Pharmaceutical Law.\u003c/li\u003e\n\u003cli\u003eNovember 2017, Borderline issues, Congr\u0026egrave;s Parfums \u0026amp; Cosm\u0026eacute;tiques, Enjeux r\u0026eacute;glementaires, Chartres.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\u003c/li\u003e\n\u003cli\u003eSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\u003c/li\u003e\n\u003cli\u003eJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London.\u0026nbsp;\u003c/li\u003e\n\u003cli\u003eMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\u003c/li\u003e\n\u003cli\u003eMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\u003c/li\u003e\n\u003cli\u003eNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Protection for Mature Product,\u0026rdquo; DIA, 28th Annual EuroMeeting, Hamburg.\u003c/li\u003e\n\u003cli\u003eApril 2016, \u0026ldquo;Interactions between regulatory and intellectual property, product liability and data privacy,\u0026rdquo; DIA, 28th Annual EuroMeeting in Hamburg.\u003c/li\u003e\n\u003c/ul\u003e","recognitions":[{"title":"Ranked in the Regulatory Practice","detail":"Best Lawyers Belgium, 2022"},{"title":"Global Elite Thought Leaders EMEA","detail":"WWL Life Sciences Report, 2022"},{"title":"Who's Who Legal, Life Sciences","detail":"2011–2022"},{"title":"Excellent in Healthcare, pharmaceuticals \u0026 biotech","detail":"Leadersleague Décideurs Belgium Life Sciences guide, 2021"},{"title":"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology","detail":"2012"},{"title":"PLC Which Lawyer?, Life Sciences","detail":"Regulatory, EU, 2012"},{"title":"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study","detail":"1988"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":8884}]},"capability_group_id":2},"created_at":"2025-11-13T04:57:39.000Z","updated_at":"2025-11-13T04:57:39.000Z","searchable_text":"Michaux{{ FIELD }}{:title=\u0026gt;\"Ranked in the Regulatory Practice\", :detail=\u0026gt;\"Best Lawyers Belgium, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Global Elite Thought Leaders EMEA\", :detail=\u0026gt;\"WWL Life Sciences Report, 2022\"}{{ FIELD }}{:title=\u0026gt;\"Who's Who Legal, Life Sciences\", :detail=\u0026gt;\"2011–2022\"}{{ FIELD }}{:title=\u0026gt;\"Excellent in Healthcare, pharmaceuticals \u0026amp; biotech\", :detail=\u0026gt;\"Leadersleague Décideurs Belgium Life Sciences guide, 2021\"}{{ FIELD }}{:title=\u0026gt;\"Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology\", :detail=\u0026gt;\"2012\"}{{ FIELD }}{:title=\u0026gt;\"PLC Which Lawyer?, Life Sciences\", :detail=\u0026gt;\"Regulatory, EU, 2012\"}{{ FIELD }}{:title=\u0026gt;\"de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study\", :detail=\u0026gt;\"1988\"}{{ FIELD }}Geneviève Michaux is a Belgian- and French-qualified lawyer in the FDA and Life Sciences practice.\nRecognized as one of the most highly regarded European Union (EU) life sciences regulatory specialists, Geneviève assists companies on a wide variety of issues under EU and national (French and Belgian) food and drug laws and regulations, with an emphasis on regulatory matters involving drugs, biologics, medical devices, cosmetics and food. She also advises life sciences clients on significant policy developments in the EU and assists with broader European and global projects.\nGeneviève’s work spans matters ranging from regulatory status of borderline products, authorization procedures, life cycle management, clinical trials and investigations, labeling, advertising and promotions for all categories of products, and issues raised by specific categories of medicinal products, such as pediatric, orphan or advance therapy medicinal products. She has advised on various issues arising out of the EU Pediatric Regulation, EU Orphan Regulation, SPC and SPC extension, and ATMPs at the European and national level. She also counsels startups on establishing themselves in the EU as well as complying with advertising and scientific information rules, regulatory and legal guidance.\nShe assists life sciences companies in forming patient/compassionate use programs in Europe, negotiating and drafting consortia related agreements, reviewing clinical trial and clinical investigation agreements, interacting with healthcare professionals in connection with advertising and promotion efforts, and product classification matters such as borderlines between drug, medical device, cosmetic and food supplement, and assistance with local authorities.\nGeneviève has extensive litigation experience in life science matters, including product liability and advertising and promotional activities.\nGeneviève is recognized as one of the \"Most Highly Regarded Individuals\" in the regulatory field (Who's Who Legal, Life Sciences 2016). In the same publication, her clients reported that she has an \"unsurpassed knowledge of legal areas,\" as well as being \"extremely dedicated to the case and the client.\" She has published numerous articles on food and drug law and speaks at legal and regulatory conferences on pharmaceuticals and medical devices.\nPublications\n\nOctober 2019, “Are the paediatric rewards adapted? “, Clinical Research in Paediatric Psychopharmacology, P. Auby, Elsevier, 2020\nMay 30, 2019, “The regulation of advanced therapy medicinal products” LexisNexis.\nApril 2017, “Pediatric Regulation – A Better application for more efficient incentives,” The European Files, Medicines of the Future.\nSeptember 2016, “Should Anthroposophic Medicinal Products Be Regulated in Europe?” Journal of European Health Law\nJune 8, 2016, “Demonstrating Significant Benefit For Orphan Medicines – Is It Time For A Drastic Change?” Scrip Regulatory Affairs.\nApril 2016, “EU Pediatric Rewards – More Questions than Answers,” Scrip Regulatory Affairs.\nFebruary 2016, “The Need For Clarification On Post-Market Requirements For Pediatric Medicines,” Scrip Regulatory Affairs.\n\nSpeaking Engagements\n\nSeptember 9, 2019, “Summary of Key EUCJ Decisions,” European Pharmaceutical Law Academy.\nJune 5, 2019, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nSeptember 10, 2018, “ATMP Regulatory Framework,” European Pharmaceutical Law Academy, Cambridge, UK.\nJune 2018, “Approval Process for Drugs and Medical Devices,” European Healthcare Industry Training: Compliance Certificate Program.\nMay 15, 2018, “International Labeling Regulatory Requirements,” co-presented with Hank Bullock, 8th Annual Medical Device \u0026amp; Diagnostic Labeling Conference in Chicago, IL.\nMarch 21, 2018, Workshop on Pediatric Regulation and SMi in London.\nMarch 2018, ATMPs – Challenges and Promises, ERA, EU Pharmaceutical Law.\nNovember 2017, Borderline issues, Congrès Parfums \u0026amp; Cosmétiques, Enjeux réglementaires, Chartres.\nSeptember 2017, SPCs and Regulatory Concepts, 9th SPC Forum, Riga.\nSeptember 2017, Pediatric Regulation, KNet365, Pharmaceutical Law Academy, Cambridge (UK).\nJune 2017, Regulatory protections, KNet365, Life Science IP Minds 2017, London. \nMarch 2017, Pediatric rewards, SMI, Pediatric Clinical Trials, London.\nMarch 2017, Revision of the Pediatric Regulation, DIA, 29th Annual EuroMeeting, Glasgow.\nNovember 2016, SPCs and Regulatory Authorizations, 7th SPC forum in Paris, France.\nApril 2016, “Protection for Mature Product,” DIA, 28th Annual EuroMeeting, Hamburg.\nApril 2016, “Interactions between regulatory and intellectual property, product liability and data privacy,” DIA, 28th Annual EuroMeeting in Hamburg.\n Partner Ranked in the Regulatory Practice Best Lawyers Belgium, 2022 Global Elite Thought Leaders EMEA WWL Life Sciences Report, 2022 Who's Who Legal, Life Sciences 2011–2022 Excellent in Healthcare, pharmaceuticals \u0026amp; biotech Leadersleague Décideurs Belgium Life Sciences guide, 2021 Legal 500, EU Regulatory and EU Pharmaceuticals and Biotechnology 2012 PLC Which Lawyer?, Life Sciences Regulatory, EU, 2012 de Harzen Prize (ULB) for excellence in Case Resolution over all five years of study 1988 Harvard University Harvard Law School Universite Libre de Bruxelles, Belgium  Paris Brussels Member of the editorial board of SCRIP Regulatory Affairs Mediator with the Brussels Business Mediation Center Member of the DIA Advisory Committee for Europe Middle East Africa Foreign Correspondent Member of the National Academy of Pharmacy (France)","searchable_name":"Geneviève Michaux","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null}]}}