definiens: shall mean products ( other than the Initial Product ( s ) ) consisting of up to 1500 USP units per vial of recombinant human PH20 hyaluronidase as the active pharmaceutical ingredient in ( i ) any liquid injectable formulation, and/or ( ii ) any lyophilized formulation in each case for DES I review indications ( cf . Federal Register, supra ) ( a ), and ( b ) ; and for non - DES I Review indication ( c ) for use as a viscoelastic antidote ( e.g., Viscolase ™ ), in each case that the parties mutually agree upon in writing in accordance with Section 3.9 . Without redefining the foregoing, expressly excludes the use of recombinant human PH20 hyaluronidase in ( i ) drugs with high - unit ( i.e. greater than 1500 USP unit ) intravenous or other doses, and ( ii ) co - formulated or combination products with molecules not owned or otherwise controlled by [COMPANY] ( unless otherwise agreed to in writing by the parties )