Requirement for the Sample Clauses

Requirement for the. Bulk Active Material to Conform to Specifications. During the Term, RegeneRx shall strictly comply with the requirements recited in the Specifications consistent with Commercial Marketing Approval for each country in the Territory. Additionally, Defiante, at its sole expense, shall be permitted, upon mutually agreeable times, to visit RegeneRx's facility, or such other facility, as is under control of RegeneRx for the purposes of Bulk Active Material manufacture, to observe the manufacture of Bulk Active Material. If RegeneRx fails to comply with the Specifications as set forth in the Commercial Marketing Approval, RegeneRx shall use all good faith and reasonable measures to promptly bring into compliance the Specifications with such Commercial Marketing Approval so that Defiante can comply with the Commercial Marketing Approval. RegeneRx, however, shall not alter, change, modify, revise, update or, in any way, vary the Specifications without previously notifying and obtaining the approval of Defiante, which approval shall not be unreasonably withheld or delayed. Thereafter, Defiante shall be responsible for securing necessary approvals to Commercial Marketing Approval by the relevant authorities. The foregoing, as applicable, shall apply to Sub-Licensees, as appropriate. It is understood that Defiante shall not alter, modify, change or, in any manner, revise the Specifications without the written approval of RegeneRx, which approval shall not be unreasonably withheld or delayed, at RegeneRx's discretion.