(a)“Action” means any audit, hearing, investigation, action, lawsuit, litigation, arbitration or other similar proceeding and any charge, complaint, claim, demand to, from, by or before any governmental authority.
(b)“Ancillary Agreement” means the Domain Names Assignment and any other agreement that the Aytu, TRIS or any of their Affiliates enter into pursuant to this Settlement Agreement or the foregoing.
(c)“Annual Report” means the annual report an NDA holder shall submit each year to FDA in accordance with 21 CFR 314.81 amd 21 CFR 312.33, and in this case, with respect to Tuzistra® XR IND no: 115598 and Tuzistra® NDA no: 207768 dated April 30, 2015.
(d)“Damages” means any loss, damage, injury, award, fine, penalty, Transfer Tax, fee, deficiency, default, settlement amount, assessment, dues, cost, liability, obligation, Encumbrance, lost profits or expense.
(e)“In-Market Aytu Product” means Tuzistra® XR inventory bearing Aytu’s (or any of its Affiliates’) NDC number that has been sold by Aytu or its Affiliates and is in the supply chain with wholesalers, retailers and other Third Parties as of the Settlement Effective Date or thereafter (including Shelf Product (as defined in Section 8(a)) ultimately sold by Aytu or its Affiliates) and includes returns of Product previously sold.
(f)“PADER” means the Periodic Adverse Drug Experience Report (PADER) in accordance with the postmarketing safety reporting requirements of 21 CFR 314.80(c)(2) and 600.80(c)(2).
(g)“Transfer Tax” means any sales, use, stock transfer, value added, real property transfer, real property gains, transfer, stamp, registration, documentary, recording or similar duties or taxes together with any interest thereon, penalties, fines, costs, fees, additions to tax or additional amounts with respect thereto incurred in connection with this Settlement Agreement.
2.Termination of License Agreement. Except for the rights and obligations created by this Settlement Agreement (including, but not limited to, rights and obligations pursuant to the Surviving Provisions (defined in Section 3), effective immediately, the License Agreement shall be terminated in all respects.
3. Surviving Provisions. The Surviving Provisions (as defined below) will survive termination of the License Agreement pursuant to this Settlement Agreement. Except as set forth in the preceding sentence, none of the terms, conditions or obligations of the License Agreement shall survive termination of the License Agreement pursuant to this Settlement Agreement. As used herein, “Surviving Provisions” means the following provisions of the License Agreement, together with the provisions of the Quality Agreement and the Safety Data Exchange Agreement to the extent such agreements survive in accordance with Paragraphs 4 and 5 below, respectively:
(a)Section 2.1(d) (which section pertains to TRIS’ right of reference);