in the marketplace or under development, the regulatory environment and the expected profitability of the applicable product (including development costs, pricing and reimbursement, cost of goods
and all other costs associated with the applicable product (including direct regulatory required support and medical affairs costs (REMS)), direct intellectual property defense costs, and direct distribution and logistics costs), and other relevant
commercial, financial, technical, legal, scientific and/or medical factors. For clarity, Diligent Efforts does not mean that the Parent guarantees that it will actually achieve any Milestone, whether at all or by a specific date.
EDSIVO means the pharmaceutical product for the treatment of vascular Ehlers-Danlos syndrome (vEDS) with
confirmed COL3A1 mutation comprising celiprolol as the sole active pharmaceutical ingredient, as described in IND No. 127365, which has been under development (including clinical development) prior to the date of this CVR
EMETINE License Milestone means, with respect to ACER-2820, no later than the
Back-End Date, the first occurrence of either (a) a sublicense or asset sale within three (3) years following receipt of initial funding by a government program of at least $20,000,000 or
(b) FDA approval of any indication.
EMETINE Sale Milestone means, with respect to ACER-2820, no later than the Back-End Date, the first occurrence of a sale of the Medical Counter Measure Priority Review Voucher.
Act means the Securities Exchange Act of 1934, as amended.
FDA means the United States Food and Drug Administration or any
FDA Approval means the approval by the FDA to commercial and manufacture or have manufactured for commercial use, in
the United States, a pharmaceutical product.
Governmental Entity means any domestic (federal or state), or foreign court, commission,
governmental body, regulatory or administrative agency or other political subdivision thereof.
Holder means a Person in whose name a
CVR is registered in the CVR Register.
Law means any foreign, federal, state, local or municipal laws, rules, judgments, orders,
regulations, statutes, ordinances, codes, decisions, injunctions, decrees, international treaties and conventions or requirements of any Governmental Entity.
Net Milestone Payment shall mean, with respect to each Milestone Payment, such Milestone Payment less any applicable Derivative Payment.
Officers Certificate when used with respect to the Parent means a certificate signed by the Chief Executive Officer, a president
or any vice president, the Chief Financial Officer or any other person duly authorized to act on behalf of the Parent for such purpose or for any general purpose.
OLPRUVA means the pharmaceutical product comprising sodium phenylbutyrate for oral suspension for the treatment of diseases, including Urea
Cycle Disorders involving deficiencies of carbamylphosphate sythetase, ornithine transcarbamylase, or argininosuccinic acid synthetase as described in NDA No. 214860 and approved by the FDA on December 22, 2022.