Ex-U.S Clause Samples
Ex-U.S. On a Collaboration Product-by-Collaboration Product basis, Merck (itself or through one or more Affiliates) will use Commercially Reasonable Efforts to Commercialize such Collaboration Product ex-U.S., and to carry out the tasks specified under the Global Commercialization Plan for Merck for such Collaboration Product ex-U.S. in a timely and effective manner and in compliance in all material respects with applicable Law.
Ex-U.S. Distribution. At least 180 days prior to distributing or selling, or engaging or licensing a Third Party to distribute or sell, a Product in a jurisdiction outside of the United States (an “Ex-U.S. Distribution”), Zomedica will provide notice to Qorvo identifying such jurisdiction and describing the details of such Ex-U.S. Distribution. During such 180 day period, Qorvo will conduct a reasonable freedom to operate investigation to identify any Third Party patent rights that would potentially be relevant to such Ex-U.S. Distribution in the applicable jurisdiction. If within 180 days after the date of such notice from Zomedica, Qorvo provides Zomedica with written notice that Qorvo objects to such Ex-U.S. Distribution in the applicable jurisdiction on the basis of reasonable concerns related to Third Party patent rights in such jurisdiction, then the Parties will meet to discuss such concerns and Zomedica may nonetheless proceed with such Ex-U.S. Distribution in such jurisdiction despite Qorvo’s objection provided that (a) Zomedica will be responsible for identifying and ensuring that it has rights under any and all patent rights (including any patent rights included in the Third Party Hardware IP Rights) necessary to develop, manufacture, use, sell, offer for sale, have made, or import each Product in such jurisdiction, and for the payment of all royalties or other amounts, if any, that are payable to Third Parties in consideration for such patent rights in such jurisdiction, and (b) if a Third Party files a claim or brings an action against any Qorvo Indemnified Party alleging that a Product, or the making, having made, use, sale, offering for sale or importation thereof, infringes any patent rights in such jurisdiction, then Zomedica will assume and have sole control of the defense of any such action or claim in accordance with Section 12.4 (Indemnification Procedure) and shall be responsible for any Losses with respect to such action or claim based on such infringement.
Ex-U.S. Payments. Following the First Commercial Sale of any Initial Product in the Field in any country outside of the U.S. and as further consideration for KemPharm’s grant of the rights and licenses to Company hereunder, Company shall pay to KemPharm the following:
(i) If Company or its Affiliates directly Commercialize such Initial Product in any country outside of the U.S., Company shall pay to KemPharm a Royalty on the Net Sales of such Initial Product in each applicable country outside of the U.S., as calculated by multiplying such Royalty rate by the corresponding aggregate annual Net Sales in each such country:
1) For that portion of aggregate annual Net Sales in each country per Calendar Year less than or equal to [*****] [*****]
2) For that portion of aggregate annual Net Sales in each country per Calendar Year greater than [*****] [*****] Net Sales of any Initial Product outside the U.S. shall not include [*****]. In addition, in no event shall the manufacture of an Initial Product give rise to a Royalty obligation. For clarity, Company’s obligation to pay Royalties to KemPharm under this Section 8.5(b) is imposed only once with respect to the same unit of Initial Product regardless of the number of Licensed Patents pertaining thereto.
(ii) If Company or its Affiliates enters into a sublicense to Commercialize such Initial Product in any country outside of the U.S., Company shall pay a one-time value share payment to KemPharm equal to [*****]. For clarity, Company shall not be obligated to make any payment to KemPharm under this Section 8.5(b)(ii) with respect to any other compensation or consideration received by Company in connection with (but after the execution of) such sublicense agreement, including any value received in the form of royalty payments.
Ex-U.S
