ArticleRegulators Offer Fresh Guidance On Using Real-World Data To Support Regulatory Decisions Further EMA pilot studies that are slated to begin running in 2022 include providing the first catalogue of RWD sources.United StatesFood, Drugs, Healthcare, Life SciencesSidley Austin LLP
ArticleIRS Tries To Change The Rules On Research Credit Refund ClaimsOn Friday, October 15, 2021, the IRS Office of Chief Counsel published a memorandum purporting to answer the question of what a taxpayer must include in a claim for refund relating to the I.R.C. § 41 Credit for Increasing Research Activities.United StatesTaxSidley Austin LLP
ArticleAnother Section 220 Landmine: Opportunistic Third-Party Challenges To ConfidentialityDelaware Section 220 corporate books and records inspection demands have long been a precursor to stockholder litigation.United StatesCorporate/Commercial LawSidley Austin LLP
ArticleCourt Concludes Government Agencies Cannot Categorize Regulatory Violations As Material As A Matter Of LawOn January 7, 2022, a district court in the Western District of Kentucky dismissed DOJ's implied false certification theory relating to allegedly medically unnecessary genetic tests...United StatesGovernment, Public SectorSidley Austin LLP
ArticleThird Circuit Adopts The Seventh Circuit's Voluntary Dismissal Standard For Evaluating Granston Motions To DismissOn October 28, 2021, the Third Circuit affirmed a district court's grant of the United States' motion to dismiss—over the relator's objection—a qui tam alleging that the defendant had caused hospitals...United StatesLitigation, Mediation & ArbitrationSidley Austin LLP
ArticleGuarding Its Turf: SPAC-Related Chancery Opinion May Force Companies To Defend Disclosure-Based Claims On Multiple FrontsCompanies that have endured a corporate trauma are often faced with a two-headed monster of litigation: first, a federal securities class action, typically alleging that misstatements or omissions inflated...United StatesCorporate/Commercial LawSidley Austin LLP
ArticleU.S. And Foreign Cybersecurity And Intelligence Agencies Recommend Measures To Counteract Threat Of Russian CyberattacksOn January 11, 2022, the Cybersecurity and Infrastructure Security Agency (CISA), the Federal Bureau of Investigation (FBI), and the National Security Agency (NSA) recently released a joint Cybersecurity Advisory...United StatesTechnologySidley Austin LLP
ArticleClimate Change Litigation – Recent DevelopmentsIn the absence of mandatory federal limits on greenhouse gas emissions, states and advocacy groups have turned their attention to the courts to achieve their goals. Three recent decisions provide an indication of what is to come. United StatesEnergy and Natural ResourcesSidley Austin LLP
ArticleIs Your Supply Chain Ready For The EU’s RoHS Directive?This update addresses one of the biggest challenges to supply chain management in years: compliance with the European Union’s Directive on the Restriction of Use of Certain Hazardous Substances (RoHS) in electronics and electrical equipment that comes into force on July 1, 2006.United StatesEnvironmentSidley Austin LLP
ArticleNew Pharmacy, Same Result: Seventh Circuit Holds That Objective Reasonableness Dooms "Usual And Customary" Pricing CaseOn April 5, 2022, in a 2-1 decision, the Seventh Circuit applied the precedent it set in United States ex. rel. Schutte v. SuperValu Inc., 9 F.4th 455 (7th Cir. 2021)...United StatesFood, Drugs, Healthcare, Life SciencesSidley Austin LLP
ArticleU.S. Department Of Commerce Expands Controls On Biotech Software In Final RuleOn October 5, 2021, the U.S. Department of Commerce, Bureau of Industry and Security, published a final rule amending the Export Administration Regulations to include controls on certain biotechnology-related software, ...United StatesGovernment, Public SectorSidley Austin LLP
ArticleSEC Encourages Self-Reporting Of Recordkeeping Violations Resulting From Employees' Use Of Personal Devices For Business CommunicationsOn December 17, 2021, the U.S. Securities and Exchange Commission announced settled charges against a broker-dealer firm for recordkeeping violations arising from its employees' use of personal devices for business communications.United StatesPrivacySidley Austin LLP
Article11th Circuit Holds Eighth Amendment Applies To FCA Monetary Awards In Non-Intervened CasesThe Eleventh Circuit recently held that the Eighth Amendment's prohibition on excessive fines applies to monetary awards in non-intervened FCA actions—the first federal court of appeals directly to address...United StatesLitigation, Mediation & ArbitrationSidley Austin LLP
ArticleECHR Ruled On Monitoring Of Employee's Electronic CommunicationThe case was originally brought by Bogdan Mihai Bărbulescu, who argued his employer had breached his right to privacy by monitoring his electronic communications. European UnionPrivacySidley Austin LLP
ArticleCorwin Cleanse Clarified: Key Lessons For Interested DirectorsSince Corwin v. KKR Financial Holdings LLC, Delaware courts have adhered to the proposition that "when a transaction not subject to the entire fairness standard is approved by a fully informed...United StatesCorporate/Commercial LawSidley Austin LLP
ArticleDelaware Court Enjoins Shareholder Meeting For Disclosure ViolationsThe Delaware Chancery Court recently issued a rare preliminary injunction delaying the shareholder vote on a proposed merger between QAD...United StatesCorporate/Commercial LawSidley Austin LLP
ArticleMore Pushback To Disclosure-Only SettlementsThe cases are very rarely litigated, allowing plaintiff lawyers to collect fees for limited effort and little risk.United StatesCorporate/Commercial LawSidley Austin LLP
ArticleTexas Supreme Court Holds Texas Commission On Environmental Quality Definition Of "Operator" Controls Over Judicial InterpretationOn February 11, 2022, the Supreme Court of Texas issued its opinion in Texas Environmental Quality et al. v. Maverick County, et al., a case that addressed the meaning of the term "operator" in the context of the application ...United StatesEnvironmentSidley Austin LLP
ArticleNew EU Legislation On Clinical TrialsThe European Commission has recently adopted a new Directive of importance to companies conducting clinical trials in the EUUnited StatesCorporate/Commercial LawSidley Austin LLP
ArticleInvestment Management Update: Client Alert Regarding New Publication RequirementsOn February 3, 2006, New York State enacted Senate Bill No. 85-A, which amends publication requirements pertaining to (1) domestic and foreign limited liability companies, (2) domestic and foreign professional service limited liability companies, (3) domestic and foreign limited partnerships and (4) domestic and foreign limited liability partnerships.United StatesCorporate/Commercial LawSidley Austin LLP