definiens: means any transaction ( including a sale of assets, spin - off, split - off or licensing transaction ), other than a Change in Control, pursuant to which ( a ) any rightsof Parent or any of its Affiliates ( including Intellectual Property rights ) ( i ) necessary for thedevelopment or commercialization of any Product or ( ii ) useful for the development orcommercialization of any Product ( other than, in the case of any useful but not necessary rights, to the extent that the applicable transaction would not reasonably be expected to result in amaterial delay in achievement of any of the Milestones ) or ( b ) all or substantially all of the assetsused or held for use in connection with any Product, in each case ( in respect of the foregoing ( a)and ( b ) ) are, directly or indirectly, disposed of, sold, licensed, assigned, conveyed, or transferredto or acquired by any Person other than by Parent or any of Parent ’s direct or indirect wholly - owned subsidiaries ( such Person, the ) . An shall not applyto ( a ) sales of a Product made by Parent or its Affiliates to distributors in the ordinary course, orordinary course licensing arrangements between Parent and its Affiliates, on the one hand, andthird party distributors, contract research organizations or contract manufacturers on the otherhand, entered into in the ordinary course of business for purposes of developing, manufacturing, distributing and selling a Product, in each case, on Parent ’s or its Affiliates ’ behalf and ( b)licenses granted by Parent or its Affiliates so long as Parent and its Affiliates retain any and allnecessary rights and useful rights ( other than, in the case of any useful but not necessary rights, to the extent that the applicable license would not reasonably be expected to result in a materialdelay in achievement of any of the Milestones ) to develop and obtain approval by the FDA andany other applicable Regulatory Authority to market and sell the Products