“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 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.
“CVRs” means the rights of Holders to receive contingent cash payments pursuant to the Merger Agreement and this Agreement.
“DB-OTO” means an AAV-based dual-vector gene therapy product candidate designed to express Otoferlin that is in development by the Company for the treatment of congenital, monogenic hearing loss.
The “DB-OTO Milestone” shall be deemed achieved upon the occurrence of the fifth (5th) human participant being administered after the date of the Merger Agreement with DB-OTO in any Clinical Trial; provided, that such occurrence is prior to the end of the DB-OTO Milestone Period.
“DB-OTO Milestone Payment” means, if the DB-OTO Milestone is achieved prior to the end of the DB-OTO Milestone Period, $2.00 in cash, per CVR, without interest and subject to reduction for any applicable withholding Taxes; provided that (i) in the case of any CVR received by a Holder in respect of a Tranche 2 Option, the DB-OTO Milestone Payment means the excess of $6.00 over the exercise price per Share with respect to such Tranche 2 Option and (ii) notwithstanding the achievement of the DB-OTO Milestone, in no event shall the DB-OTO Milestone Payment be made with respect to any CVR received by a Holder in respect of a Tranche 3 Option. For the avoidance of doubt, the DB-OTO Milestone Payment shall only be due once, if at all.
“DB-OTO Milestone Period” means the period commencing on the Closing Date and ending on the earlier of (i) the Termination and (ii) at 11:59 P.M., Eastern Time on December 31, 2024.
“DTC” means The Depository Trust Company or any successor thereto.
“Equity Award CVR” means a CVR received by a Holder in respect of a Tranche 1 Option, Tranche 2 Option, Tranche 3 Option or Company RSU.
“Governmental Body” shall mean any applicable: (a) nation, state, commonwealth, province, territory, county, municipality, district or other applicable legal jurisdiction; (b) federal, state, local, municipal, foreign, international, multinational, supranational or other government; or (c) governmental authority of any nature including any governmental division, unit, department, agency, commission, instrumentality, official or body and any court, arbitrator or other tribunal.
“Holder” means, at the relevant time, a Person in whose name a CVR is registered in the CVR Register.
“IND” means an Investigational New Drug Application filed with the U.S. Food and Drug Administration (“FDA”) pursuant to 21 C.F.R. § 312 before the commencement of Clinical Trials, including all amendments and supplements to such application, or any equivalent filing with any Regulatory Authority outside the United States.