Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
New Pharmaceutical Agreement Notification Filing Requirements
As of Jan. 7, 2004, pursuant to Section 1112 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products are required to be filed with the Federal Trade Commission and the U.S. Department of Justice. In addition, certain agreements between generic drug manufacturers, each of which have filed certain types of applications with the FDA for the same brand-name drug product, must also be filed. However, agreements that concern only purchase orders for raw materials, equipment and facility contracts, employment or consulting contracts or packaging and labeling contracts need not be reported. The filing requirements cover agreements executed on or after Jan. 7, 2004.
Any agreement subject to the new law must be within 10 business days of the date the agreement was executed. The penalty for failure to file can be up to $11,000 per day.
The new requirements are being implemented because the FTC believes that agreements between brand-name and generic drug companies can have the effect of delaying entry to the market of generic drugs. Using these filings, the anti-trust agencies will be able to monitor the effects of these agreements on trade.
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.