definiens: means any transaction ( including a sale of assets, spin - off, split - off or licensing transaction ), other than aChange in Control, pursuant to which ( a ) any rights of Parent or any of its Affiliates ( including Intellectual Property rights ) ( i ) necessary forthe development or commercialization of any Product or ( ii ) useful for the development or commercialization of any Product ( other than, inthe 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 assets used or held for use in connection with anyProduct, in each case ( in respect of the foregoing ( a ) and ( b ) ) are, directly or indirectly, disposed of, sold, licensed, assigned, conveyed, ortransferred to 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 apply to ( a ) sales of a Product made by Parent or its Affiliates to distributors in theordinary course, or ordinary course licensing arrangements between Parent and its Affiliates, on the one hand, and third party distributors, contract research organizations or contract manufacturers on the other hand, entered into in the ordinary course of business for purposes ofdeveloping, manufacturing, distributing and selling a Product, in each case, on Parent ’s or its Affiliates ’ behalf and ( b ) licenses granted byParent or its Affiliates so long as Parent and its Affiliates retain any and all necessary rights and useful rights ( other than, in the case of anyuseful but not necessary rights, to the extent that the applicable license would not reasonably be expected to result in a material delay inachievement of any of the Milestones ) to develop and obtain approval by the FDA and any other applicable Regulatory Authority to marketand sell the Products . For purposes of this definition, any delay that reasonably would be expected to result in failure to achieve any of theMilestones hereunder shall be deemed to be a means the board of directors of Parent or any other body performing similar functions, or any duly authorizedcommittee of that board