definiens: mean information t hat includes, but is not limited to, physical descriptions, testing methods and expected assay values, which recite the strict requirements for Bulk Activ e Material to be incorporated into the Finished Products as permitted under the F ield of Use for the Territory, which are subject to Commercial Marketin g Approval by the relevant authorities for each country in the Territory . The Specifications may be modified from time to time by RegeneRx upon reasona ble prior notice to [COMPANY] and subject to approval by the relevant regulatory authorities for Commercial Marketing Approval for each country in the Territor y. It is understood that additions or modifications to the Specifications ma y be required by relevant regulatory authorities for Commercial Marketing App roval for each country in the Territory from time to time throughout the Term her ein . The Specifications in effect as of the Effective Date are attached as Att achment B, which is made a part hereof by reference