“Carve-Out Transaction” means any transaction (including a sale of assets, merger, sale of stock or other equity interests, or exclusive licensing transaction) pursuant to which all or substantially all of the rights, property and assets (including Intellectual Property and Material Contracts) necessary for the development and approval of DB-OTO are sold, exclusively licensed or otherwise transferred, directly or indirectly, to, or acquired by, directly or indirectly, a Person other than Parent or any of its Affiliates. For clarification, each of (i) ordinary course licensing, collaboration or distribution arrangements in which less than exclusive worldwide rights are granted for purposes of developing or commercializing DB-OTO and (ii) any Change of Control shall not constitute a Carve-Out Transaction.
“Change of Control” means (a) a sale or other disposition of all or substantially all of the assets of Parent on a consolidated basis (other than to any Subsidiary (direct or indirect) of Parent), (b) a merger or consolidation involving Parent in which Parent is not the surviving entity, and (c) any other transaction involving Parent in which Parent is the surviving or continuing entity but in which the stockholders of Parent immediately prior to such transaction (as stockholders of Parent) own less than 50% of Parent’s voting power immediately after the transaction.
“Clinical Trial” means any research study in which one or more human subjects are assigned to one or more interventions (which may include placebo or other control), including the Phase 1/2 Clinical Trial, any Phase III Clinical Trial or any Registration Enabling Trial, in each case, including an equivalent human clinical trial conducted in a country other than the United States.
“Commercially Reasonable Efforts” means a level of efforts that is consistent with the general practice followed by Parent in the relevant jurisdictions in pursuing development and approval of other pharmaceutical compounds, products or therapies owned by it, or to which it has exclusive rights, which are of similar scientific and commercial potential at a similar stage in their development or product life, taking into account all relevant factors, including the prevalence and incidence of the applicable disease or condition, safety, tolerability, efficacy, product profile, anticipated regulatory authority approved labeling, supply chain management considerations, the competitiveness of other products of the Parent and third parties in development and in the marketplace, proprietary position (including with respect to patent or regulatory exclusivity), the projected cost, the regulatory structure and requirements involved (including with respect to Clinical Trial enrollment), and expected profitability (including pricing and reimbursement status achieved or expected to be achieved), and, in each case, other relevant technical, scientific, strategic, commercial, legal, regulatory or medical factors (without limiting Parent and Purchaser’s ability to allocate their respective resources in accordance with their respective development and commercial priorities). It is understood and agreed that, depending on the relevant facts and circumstances, Commercially Reasonable Efforts may not require Parent to test, develop, pursue, manufacture, make regulatory filings or seek regulatory approvals with respect to, or otherwise advance, DB-OTO. Any Milestone Payments payable under this Agreement may not be taken into account in determining Commercially Reasonable Efforts.
Notwithstanding anything to the contrary herein, including but not limited to the foregoing and Section 4.03, “Commercially Reasonable Efforts” shall not require: (i) opening any new sites for Clinical Trials beyond those having been opened or expressly planned to be opened pursuant to the Company’s development plans shared with Parent as of August 8, 2023; or (ii) initiating any additional Clinical Trials beyond the Phase 1/2 Clinical Trial.
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