Regulatory Milestone definition
Regulatory Milestone has the meaning set forth in Section 5.2.
Regulatory Milestone means the receipt of Marketing Authorization for Menadione Topical Lotion from any Regulatory Authority.
Regulatory Milestone shall have the meaning set forth in Section 3.2.
Examples of Regulatory Milestone in a sentence
For clarity, the Regulatory Milestone shall be paid to the Paying Agent or the Surviving Company, in each case, for further distribution to the applicable Securityholders, in accordance with Section 3.05 only once regardless of the number of times a Follow-on Product achieves a Regulatory Milestone.
More Definitions of Regulatory Milestone
Regulatory Milestone means the written clearance by the FDA of the Premarket Notification.
Regulatory Milestone has the meaning provided in Section 8.4.
Regulatory Milestone has the meaning set forth in Section 10.2.1 (Regulatory Milestone Payments).
Regulatory Milestone has the meaning set forth in Section 6.2. (ooo) “Representatives” has the meaning set forth in Section 11.2. (ppp) “Royalty Term” means, on a country-by-country basis, the period of time commencing upon the first sale by Viatris, its Affiliates and permitted sublicensees of the Product in each country in the Territory and continuing until [**]. (qqq) “Term” has the meaning set forth in Section 12.1. (rrr) “Territory” means worldwide, but excluding (a) the United States of America and (b) all members of the European Union as of October 4, 2024, and Albania, Andorra, Bosnia and Herzegovina, Iceland, Kosovo, Liechtenstein, Moldova, Monaco, Montenegro, North Macedonia, Norway, San Marino, Serbia, Switzerland, United Kingdom (including Ireland) and Vatican City. (sss) “Trade Control Laws” has the meaning set forth in Section 8.4(a). (ttt) “T1D” means Type 1 Diabetes. (uuu) “Third Party” means any Person other than a Party or an Affiliate of a Party. (vvv) “Trademark” means any word, name or symbol, or any combination thereof, whether registered or unregistered, including any trademark, trade dress, or trade name. (www) “Unauthorized Product Sales” has the meaning set forth in Section 4.6. (xxx) “Valid Claim” means: (a) a claim of an issued and unexpired patent within the Licensed Intellectual Property that has not been (i) held permanently revoked, unenforceable, unpatentable or invalid by a decision of a court or Governmental Body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, (ii) rendered unenforceable through disclaimer or otherwise, (iii) abandoned or (iv) permanently lost through an interference, inter parties review, opposition or other proceeding without any right of appeal or review; or (b) a pending claim of a pending patent application within the Licensed Intellectual Property, where [**].
Regulatory Milestone means the satisfaction of each of the following events: (a) no default or Event of Default shall have occurred and be continuing; and (b) receipt by the Agent of evidence in form and substance reasonably satisfactory to it that Borrower has filed the New Drug Application for TP-03 for the treatment of Demodex Blepharitis with the FDA.
Regulatory Milestone has the meaning set forth in Section 2.9(c).
Regulatory Milestone means receipt of the first MAA Approval, BLA Approval or NDA Approval for a Company Product.