Existing Product

Existing Product. Shall mean, as to a Party, any product (i) that such Party or any of its Affiliates as of April 15, 2005 has offered for sale, is offering for sale, or (ii) in respect of which such Party or any of its Affiliates as of April 15, 2005, has filed with the United States Food and Drug Administration a Section 510(k) Premarket Notification or a Section 515 Premarket Approval; and any apparatus used to manufacture (including develop, assemble, test, repair or maintain) any such product. "Existing... Products" shall include, without limitation, the products set forth in Exhibit A, so long as such products meet the criteria set forth in this Section. View More