Basic concepts and issues: a primer on distribution and sales representative agreements in the medical device and durable medical equipment industries

Counsel for a manufacturer of medical devices or durable medical equipment must have working knowledge of various legal disciplines to draft contracts with intermediaries (sales representatives and distributors) for the marketing and sale of the manufacturer's products. If the manufacturer wishes to sell its products abroad, counsel must become familiar with the laws and business practices of the target country, and methods of gaining access to the foreign market. This Article gives readers an overview of the applicable legal principles, under U.S. and foreign laws, in the areas of agency, contracts, healthcare regulation, consumer protection, intellectual property protection, and dealer protection. To aid counsel in drafting intermediary agreements, specific contractual terms and issues are explored in depth, including: appointment clauses, performance provisions, provisions concerning pricing and payment, protective clauses (shielding the manufacturer from liability), term and termination provisions, independent contractor clauses, export control clauses, recordkeeping and audit provisions, choice of law clauses, and dispute resolution clauses.