LAW 2727 - Medical Product Development and Licensing Agreement Drafting Seminar
This writing course provides participants with the opportunity to draft the form of agreement used in the medical products industry for collaborative development and licensing of new regulated medical products. Regulated medical products include drugs, biologics, medical devices, and cell, tissue, and gene therapies. CD&L agreements cover the major steps and interparty interactions along the pathway from product discovery to regulatory approval. As such they integrate several legal disciplines – contracts, intellectual property, licensing, medical product regulation, federal funding of technology development, venture governance and dispute resolution, commercial transactions, insurance, finance, and litigation. The course will reinforce several important principles that extend beyond the life science industry and collaborative development and licensing agreement on which the course focuses. These principles include the importance of understanding the business and interests of clients and their counterparties, the limits to which contracts can protect the interests of clients and their counterparties, and the dynamic impact of applicable statutory, regulatory, and case law on various matters covered in contracts. During the semester, each participant will be engaged as counsel by various hypothetical clients to draft (and sometimes negotiate) contractual provisions for varying hypothetical medical product development projects.
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