definiens: means any topical anti - infective product for human ocular or ophthalmic indications, inany dosage strength or size, for any mode of ocular or ophthalmic administration, containing as the sole active ingredient thechemical compound known as azithromycin or any salts, esters or hydrates thereof ; provided, however, that, unless and untilInspire exercises the AzaSite Xtra Option pursuant to Section 2.12(h)(ii ) below, Subject Product does not include AzaSiteXtra . ” * * * CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION * * * 1.2 Addition of New Definitions . The following defined terms are hereby added to Article 1 of the Agreement : means any topical anti - infective product for human ocular or ophthalmic indications, in any size, forany mode of ocular or ophthalmic administration, containing as the sole active ingredient two percent ( 2 % ) by weight of thechemical compound known as azithromycin or any salts, esters or hydrates thereof