Cooley LLP

Alert: FDA Maintains Assigned Unique Suffixes in Generic Names for Biologics

On January 12, 2017, the FDA issued its final guidance on generic naming for biological products submitted pursuant to 351(a) or (k) of the Public Health Service Act. The guidance is titled Nonproprietary Naming for Biological…more
| Health, Science, Computers, & Technology

Blog: SEC Charges Company With Violations Of The Rules Related To Non-GAAP Financial Measures

The Corp Fin staff have been dropping hints for quite a while about potential enforcement actions in connection with abuses of non-GAAP financial measures, and now one has finally materialized. In an Order released today, the…more
| Business Organizations, Finance & Banking, Securities Law

Blog: KPMG Surveys Audit Committee Concerns

What are audit committee members’ greatest concerns? Audit committee members participating in KPMG’s 2017 Global Audit Committee Pulse Survey identified risk management as the biggest challenge for audit committees in 2017, with…more
| Business Organizations

Alert: New Federal Law Prohibits Non-Disparagement Provisions in Form Contracts

A new federal law provides protection for US consumers who post negative reviews online.1 The Consumer Review Fairness Act of 2016 (the "Act") prohibits companies from including provisions in their form agreements that ban or…more
| Antitrust & Trade Regulation, Commercial Law & Contracts, Communications & Media Law

Alert: New Privacy Training Requirements for Companies with Federal Government Contracts

Effective January 19, 2017, companies awarded federal government contracts will be required to ensure that their employees receive annual privacy training if those employees (1) handle personally identifiable information…more
| Privacy, Science, Computers, & Technology, Government Contracting

Blog: Government Considering Reform To Hold Companies More Accountable For Economic Crime

The Ministry of Justice has announced that it has commenced a consultation with businesses on the introduction of legislation aimed at tackling corporate economic crime and is seeking views on the extent to which reform is…more
| Business Organizations, Commercial Law & Contracts, Criminal Law

Blog: OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare…more
| Government Contracting, Health

Blog: FDA Issues Discussion Paper on Laboratory Developed Tests

The U.S. Food and Drug Administration (FDA) issued today a Discussion Paper on Laboratory Tests (LDTs). The Discussion Paper follows draft guidance issued by the FDA in 2014 (2014 Draft Guidance) and a stakeholder workshop held…more
| Health

Blog: It Didn’t Take Long — House Passes Bills To “Regulate” The Regulators

Welcome to the future! On Wednesday, the House Republicans (with five Democratic votes) passed H.R. 5, the Regulatory Accountability Act of 2017, a bill that would change the way federal agencies issue regulations and guidance…more
| Securities Law

Alert: Export Control Reminder: Encryption Reporting Deadline 2/1/17

The new year brings with it the reporting deadlines for exports of encryption items under the US Export Administration Regulations (“EAR”). February 1, 2017 is the deadline for submitting annual self-classification reports for…more
| International Law & Trade

Alert: Antitrust 2017: Trends and Developments to Watch

1. Transition to a Trump Administration is top of the agenda - President-elect Donald Trump's DOJ and FTC transition team appointments and public short list of candidates to run the agencies indicate that antitrust…more
| Alternative Dispute Resolution (ADR), Criminal Law, Elections & Politics, International Law & Trade, Labor & Employment Law

Alert: EU Privacy Q&A – Network and Information Security Directive

The UK Government has published its report entitled "Cyber Security Regulation and Incentives Review"), which sets out its intentions following Brexit on the implementation of the Network and Information Security Directive…more
| International Law & Trade, Privacy, Science, Computers, & Technology

Blog: Commercial Court provides guidance on interaction between aggregation and excess clauses

In Spire Healthcare v Royal Sun Alliance Insurance plc [2016] EWHC 3278, the claimant sought declarations to the effect that an insurance policy it held with the defendant insurer contained no operative aggregation clause such…more
| Civil Procedure, Commercial Law & Contracts, Insurance

Blog: Data Points from Recent Appraisal Decisions

As concerns over the potential exercise of appraisal rights are increasingly being factored into deal price, data points from recent Delaware appraisal decisions may help inform a party of its appraisal risks and, if an…more
| Business Organizations, Civil Procedure, Mergers & Acquisitions

Blog: Is There A Fix For Short-Termism?

Much has been written about the problems associated with the prevalence of short-term thinking in corporate America. As noted in a post from The Harvard Law School Forum on Corporate Governance and Financial Regulation, a…more
| Business Organizations, Commercial Law & Contracts, Finance & Banking, Securities Law
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