New Ulesfia definition
New Ulesfia means an FDA-approved Ulesfia® (benzyl alcohol) Lotion having a unique form and/or strength as compared to the currently marketed product — 5% benzyl alcohol (50mg/g of lotion) — that is approved pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act in reliance on the Ulesfia NDA.
New Ulesfia means an FDA-approved Ulesfia® (benzyl alcohol) Lotion having a unique form and/or strength as compared to the currently marketed product — 5% benzyl alcohol (50mg/g of lotion) — that is approved pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act in reliance on the Ulesfia NDA .
Examples of New Ulesfia in a sentence
On a date no later than thirty (30) days following the date on which the Company or another Company Entity or any Affiliate thereof receives FDA Approval for New Ulesfia, Purchaser shall pay the FDA Approval Milestone Payment, allocated between the Sellers in proportion to their Percentage Interests, with any cash portion of such payment paid by wire transfer of immediately available funds to the account(s) designated in writing by the Sellers.