development and stability testing, toxicology, formulation, process development, quality assurance/control development, statistical analysis, clinical studies, quality of life assessments, pharmacoeconomics, post-marketing studies, label expansion studies, regulatory affairs, and further activities relating to development or preparation of STS101 for commercialization, (B) the manufacture, production or processing of STS101 including the active pharmaceutical ingredient, delivery device and other components therein, including activities performed in support of CMC (chemistry, manufacturing and controls), formulating active pharmaceutical ingredients into the final dosage form for incorporation into STS101 packaging, sterilization, physical and regulatory labeling and other finishing activities, quality control and assurance testing, in each case with respect to STS101, or (C) the promotion, sales, marketing, and distribution for sale of STS101 (including importing, exporting, transporting, customs clearance, warehousing, invoicing, handling, and delivering STS101 to customers), sales force efforts, detailing, advertising, market research, market access (including price and reimbursement activities), marketing, and sales (including receiving, accepting, and filling orders) and distribution for sale, and all activities directed to obtaining pricing and reimbursement approvals for STS101 any and all medical education activities, including medical support planning, health economics and outcomes, publications and pharmacovigilance for STS101; and, in each case (A), (B) and (C), together with all interactions with regulatory and other governmental authorities and other regulatory affairs in support of or related to any of the foregoing.
“Approval Date” means the date the FDA provides notice of approval of the STS101 NDA.
“Board of Directors” means the board of directors of Parent.
“Board Resolution” means a copy of a resolution certified by a duly authorized officer of Parent to have been duly adopted by the Board of Directors and to be in full force and effect on the date of such certification, and delivered to the Rights Agent.
“Business Day” means any day other than a Saturday, Sunday or a day on which banking institutions in San Francisco, California or New York, New York are authorized or obligated by law or executive order to remain closed.
“CVR” means the rights of CVR Holders to receive CVR Payment Amounts pursuant to the Merger Agreement and this Agreement.
“CVR Holder” means a Person in whose name a CVR is registered in the CVR Register, who shall initially be the Holders.
“CVR Payment” means a payment in cash of any CVR Payment Amount hereunder.
“CVR Payment Amounts” (and each a “CVR Payment Amount”) means the aggregate amounts listed in Column B of Exhibit A to be paid to CVR Holders, which payment obligation is subject to and contingent upon the achievement of the Aggregate Cumulative Net Proceeds listed in Column A of Exhibit A, in each case, with respect to such achievement occurring prior to the CVR Program Outside Date (the date of each such achievement the “Threshold Achievement Date”).
“CVR Program” means the STS101 program controlled by STSA prior to the Closing Date, and the Parent Group after the Closing Date.
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