This may be too simple way of looking at things, but if Xperience required it's own FDA clearance how could it be considered the same or improved version of the Bactisure product? Surely compensation for the time, resources, and IP gone into Xperience could not be covered under an existing exclusive distribution agreement for a separate medical product which was subject to a separate 510(k) application with the FDA...?
Ann: Zimmer complaint, page-64
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