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Pre-Label and Off-Label Statements: How to Minimize Risk When Making Statements About Regulated Products Prior to FDA Clearance or Approval [Part 1 – Pre-Label Promotion Law]

Clinical-stage pharmaceutical, biotechnology and medical device companies need to generate “buzz” in order to attract investments to fund the costly clinical studies required for marketing approval.But FDA regulations prohibit companies from promoting…

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How Game Development Companies Are Different (Part 1 – Funding)

When I tell people I work with game developers and publishers, I am often asked “what do you do for them?” Another way to think about this question might be “how are…

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Inspiration to Start 2017

Can you believe we are starting another new year? Crazy! As we all begin New Year’s resolutions, take a peek at these inspirational tips/quotes our team lives by. It doesn’t have to…

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The Future of Non-Competes

Non-compete agreements have long been an embattled area of employment law, particularly in startup industries where innovation and intellectual property protection are paramount. Recently, these agreements have come even further under fire,…

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Changes to the DMCA May Make Many Websites Liable for Copyright Infringement

Changes to the regulations related to the Digital Millennium Copyright Act will soon require that online service providers electronically register (and re-register) their DMCA agent. Previously, this was a paper filing to…

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USCIS Proposes Rule to Grant Parole for Immigrant Entrepreneurs of U.S. Startups

The Department of Homeland Security (DHS) recently released a proposed rule that would, if implemented, allow United States Citizenship and Immigration Services (USCIS) to grant parole on a case-by-case basis to certain…

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What were you doing in 1996?

As we continue to celebrate our 20th year in business, we asked the members of the team that weren’t here in 1996 what they were doing the year the firm first opened…

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Mum’s The Word – Nondisclosure Agreements, Confidential Disclosure Agreements and Confidentiality Agreements

What are the different types of NDAs?Nondisclosure Agreement, Confidential Disclosure Agreement, Confidentiality Agreement, NDA, CDA and so on. Regardless of the title, companies sign agreements promising to be quiet on a regular…

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Why and How to Organize Your Dataroom

Before a major financing transaction or the sale of a company, the investor or buyer will want to see most of the company’s legal and financial documents. This is called “due diligence.”…

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Markedly Misunderstood: 4 Common Misconceptions About Trademarks

Everyone is familiar with Trademarks. We are literally surrounded by them. Trademarks are the words, logos, packaging and other devices that we use to differentiate goods and services from each other and…

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