Modified Specifications. CyDex may change the Specifications during the Term with written notification to Company. In such event, CyDex shall give Company at least [***] ([***]) days to respond to such notice of change. Company and CyDex shall cooperate regarding initiating any changes to the Specifications and to have such change approved by all regulatory agencies having jurisdiction. In addition, if any regulatory agency having jurisdiction requires CyDex to implement any changes to the Specifications, CyDex shall use all reasonable efforts to make such changes. If a regulatory agency requires a change to the Specifications where such change is specific to Captisol as implemented in the Licensed Product, then [***] shall be responsible for the costs incurred to generate such unique, modified Specifications, provided that the parties will mutually agree on such costs prior to CyDex’s commencement of implementation of such change. In the event of a change initiated by CyDex, if requested by Company, CyDex shall provide to Company the right to purchase an amount of Captisol not greater than a [***] ([***]) [***] supply prior to such change in Specifications in order to allow the Company to maintain supply of Licensed Product until the new Specifications are validated with Licensed Product.
Appears in 3 contracts
Sources: License and Supply Agreement (Melinta Therapeutics, Inc. /New/), License and Supply Agreement (Rib-X Pharmaceuticals, Inc.), License and Supply Agreement (Rib-X Pharmaceuticals, Inc.)