definiens: means any federal, national, regional, state, loc al, county, city, municipal, town, village, distric t, foreign orother constitution, law, statute, treaty, rule, reg ulation, ordinance, order, code, binding case law o r principle ofcommon law or any condition or term imposed pursuan t to any Governmental Authorizations ; means liabilities, debts or other obligations of any kind or nature, whether known or unknown, absol ute, accrued, contingent, liquidated, unliquidated or ot herwise, due or to become due or otherwise, and whe ther or notrequired to be reflected on a balance sheet prepare d in accordance with GAAP ; means any loss, Proceeding, Judgment, damage, fin e, penalty, expense ( including reasonable attorneys ’ orother professional fees and expenses and court cost s ), injury, diminution of value, Liability, Tax, En cumbrance orother cost or expense ; means any event, change, circumstance, effect or other matter that has, or couldreasonably be expected to have, either individually or in the aggregate with all other events, changes, circumstances, effects or other matters, with or without notice, l apse of time or both, a material adverse effect on : ( a ) the business, assets, Liabilities, properties, condition ( financi al or otherwise ), operating results or operations o r prospects of theBusiness and the Transferred Assets of the Business taken as a whole ; or ( b ) the ability of the Seller or any of itsrespective Affiliates to perform its material oblig ations under this Agreement, the Ancillary Agreemen ts or toconsummate timely the transactions contemplated by this Agreement or the Ancillary Agreements ; provide d, however, that a shall exclude an y event, circumstance, change or other matter thatgenerally affects Persons engaged in the business o f developing, manufacturing, marketing, or selling API for penemand / or penicillin pharmaceutical products for human and/or animal prophylactic or therapeutic uses, ex cept to theextent such event, circumstance, change or other ma tter has a materially disproportionate effect on th e Business, taken as a whole, relative to other businesses enga ged in the API business ; and/or means a pharmaceutical product containing ( a ) a n ew, novel and innovator chemicalcompound ( ) or ( b ) a new, novel and innovator biological subs tance derived from a living organism or a DNAor RNA mechanism ( ), in each case, ( a ) and ( b ), ( i ) in any therapeut ic class and for all human and animalprophylactic and therapeutic uses in all formulatio ns and dosage forms and for any and all indications, ( ii ) whichcould not be commercialized in the United States wi thout first filing a NDA or a new therapeutic Biolo gic LicenseApplication ( ), as the case may be, and obtaining the approval of the FDA to such NDA or BLA, as the casemay be, and ( iii ) which upon obtaining such approva l of the FDA to such NDA or BLA, as the case may be, has beengranted, or could reasonably be expected to be 13 CONFIDENTIAL TREATMENT [ * * * ] Indicates that text has been omitted which is the s ubject of a confidential treatment request . This te xt has beenseparately filed with the SEC