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A self-described “small business” recently succeeded in obtaining an interim injunction (restraining an alleged abuse of dominance) in a UK court against the giant telecom provider Telefónica (trading in the UK under the name O2). This…more
The extent of an employer’s duty to provide reasonable accommodations to employees with mental impairments can be difficult to discern, especially in where an adverse action is taken in connection with conduct that is caused by or…more
When submitting a bid, contractors must take care to fulfill all pre-bid obligations to help the project run smoothly. What are the most important pre-bid actions to take? I was reminded of three critical points every contractor should…more
Blog: HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 2015
On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal…more
Statute Permits Domestic Discovery for Foreign Opposition Proceedings - Akebia Therapeutics, Inc. v. FibroGen, Inc.
With ample citation to Supreme Court precedent, the U.S. Court of Appeals for the Ninth Circuit affirmed the use of 28 U.S.C. § 1782 to conduct domestic discovery in aid of foreign opposition proceedings at the European and Japanese…more
Pacto Establece Relación de Colaboración Constante Entre las Dos Entidades - ORLANDO, Fla. -- La Oficina del Distrito de Miami de la Comisión Para la Igualdad de Oportunidades en el Empleo (EEOC) firmó un Memorando de…more
The International Franchise Association (IFA) has filed a Freedom of Information Act (FOIA) request with the Occupational Safety & Health Administration (OSHA) asking for the rationale behind questions that its inspectors are asking…more
New guidance from the Health Resources Services Administration (HRSA) clarifying certain definitions integral to the 340B Drug Pricing Program (“340B Program”) will significantly limit the number of patients eligible to receive 340B…more
The Affordable Care Act’s Reporting Requirements for Carriers and Employers (Part 7 of 24): Mergers and Acquisitions
When it comes to mergers and acquisitions involving at least one applicable large employer (ALE), the substantive rules governing employer shared responsibility (under Internal Revenue Code § 4980H) and the corresponding reporting…more
A number of biosimilar makers have turned to inter partes review (IPR) proceedings in order to challenge innovator patents prior to submitting their biosimilar applications to FDA. IPRs have been attractive to biosimilar makers because…more
Why should you care? Subsidy certification of even one applicant claiming to be a full-time employee not offered affordable, qualifying 2015 coverage can cause the IRS to assess a non-deductible tax against the applicant’s alleged…more
On August 24, 2015, the Federal Trade Commission (“FTC” or the “Commission”) filed a proposed settlement in federal court regarding alleged violations by Third Point LLC (“Third Point”) of the premerger reporting laws related to Third…more