definiens: shall mean ( a ) any material impairment of or material adverse change in ( i ) the validity or enforceability of any of the Transaction Documents, ( li ) the ability of any [COMPANY] Entity to satisfy and perform any of its obligations under any of the Transaction Documents or consummate the transactions contemplated thereby, ( iii ) the right of DOSIII 12524688.1 6 any [COMPANY] Entity to receive any material payments payable under any Included License Agreement or any other material rights and remedies of any Oyax Entity under any Included License Agreement, or ( iv ) the right of the Buyer to receive andlor exercise the Royalty Interests or any other payment or right due to the Buyer under the Transaction Documents ; ( b ) a material adverse change affecting the Included Products or in the level of current or expected future lncluded Products Payments ( based upon the Financial Model ) ; ( c ) any Bankruptcy of [COMPANY], ( d ) any material adverse change in the business, operations, asset or financial condition of any Oyax Entity, taken as a whole, that could reasonably be expected to have a material adverse effect on the ability of that [COMPANY] Entity to perfonn any of its obligations under this Agreement or any of the Transaction Docwnents ( if applicable to that [COMPANY] Entity ) or ( e ) any material impainnent of the validity, enforceability or transferability of any [COMPANY] JP, any material challenge to or any material litigation involving any [COMPANY] IP, or any material impainnent of the prospects for any renewal or extension of the tenn of any [COMPANY] JP, shall mean a New Drug Application, and all amendments and supplements thereto, for regulatory approval by the FDA as defined in 21 C.F.R. § 314.50 et seq ., as such act or regulations may be amended, supplemented or replaced from time to time, or an equivalent application for approval filed with a Regulatory Agency in any other jurisdiction within the Territory, shall have the meaning attributed to such tenn in the Wyeth License Agreement, it being understood be first calculated in the currency of sale and then converted into U, S, dollars at the conversation rate existing in the United States ( as reported in the Wall Street Journal ) on the last working day of the calendar quarter preceding the applicable calendar quarter