definiens: means ( i ) a material adverse effect o n the legality, validity or enforceability of any provision of this Agreement, ( ii ) a material advers e effect on the ability of the Seller to perform an y of its obligations hereunder, ( iii ) a material adverse eff ect on the rights or remedies of the Buyer hereunde r, ( iv ) an adverse effect on the rights of the Seller under th e License Agreement or the Sponsored Research Agree ment, other than as a result of Credit Event, that has a material adverse effect on the Royalty, ( v ) an adve rse effect on the performance of the parties under the License Ag reement or the Sponsored Research Agreement, includ ing related to the approval or commercialization of the Products, other than as a result of a Credit Event, that has a material adverse effect on the Royalty, or ( vi ) any other adverse effect in any material respect on th e timing, amount or duration of the payments to be made to th e Buyer in respect of any portion of the Royalty or the right of the Buyer to receive such payments, in each case other than as a result of a Credit Event or Permit ted Royalty Reduction ; provided, however, that a delay in obtai ning or failure to obtain regulatory approval for a ny Product shall not in and of itself constitute a Product MAE, it being understood that the underlying facts and circumstances giving rise to such delay or failure may constitute, and may be taken into account in de termining whether there has been, a Product MAE as described in the foregoing clauses ( i)-(vi )