Common use of Orange Book Listing Clause in Contracts

Orange Book Listing. The Parties hereto shall cooperate with each other and discuss in good faith, as to any particular Product, what Patent Rights should be listed in the “Orange Book” and other similar national (or supranational) equivalents thereto. Astellas shall have the sole right, after good faith reasonable discussion with Ambit, to make all filings with the Regulatory Authorities with respect to Ambit Licensed Patents and Program Patents and Astellas Patents in connection with required regulatory activities for Products, including as required or allowed in connection with: (i) in the United States, the FDA’s Orange Book and (ii) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents. Ambit shall, at Astellas’s expense, (A) provide to Astellas all Information in Ambit’s Control, including a correct and complete list of Ambit Licensed Patents and Ambit Program Patents covering any Product or otherwise necessary or reasonably useful to enable Astellas to make such filings with Regulatory Authorities with respect to the Products, and (B) cooperate with Astellas’s reasonable requests in connection therewith, including meeting any submission deadlines, in each case, to extent required or permitted by Applicable Law. Astellas shall notify Ambit in writing of any such filings with the Regulatory Authorities with respect to the Ambit Licensed Patents or the Program Patents.