Regulatory Services
In-Licensing

Need
• Small pharmaceutical company sought to persuade a technology development company to grant an exclusive license to a patented control release technology in order to market a unique OTC drug
• Principals in company unfamiliar with pharmaceutical regulatory and licensing requirements

Approach
• Advised both parties that an NDA would be facilitated by the amount of safety and efficacy data already available on the active ingredients
• Persuaded technology development company to license their technology for the field of OTC applications which would be beneficial to their business without jeopardizing their primary interest in licensing the technology for prescription drugs
• Negotiated and drafted worldwide licensing agreement with option to add additional OTC drugs

Benefits
• Terms of agreement very favorable to client, including time to study markets of interest prior to investing in development funds
• Both parties serve on Development Committee, thereby facilitating the identification of development candidates and expediting development timelines