Product Improvement

Product Improvement. Means, on a country-by-country basis, any modification or line extension of the Product, or accessory that is designed for use with the Product, that: (a) is developed by Aerogen, or by MIA as permitted in Section 3.4(a); and (b) does not require any separate 510(k) marketing clearance, Premarket approval (PMA) application, Biologics License Application (BLA), or New Drug Application (NDA) regulatory filing or approval, or any foreign equivalent thereto, to promote, market and... sell a Product containing such modification or line extension or accessory in the Territory. 3 View More