Common use of Modified Specifications Clause in Contracts

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term. In such event, CyDex shall provide to Company at least [***] written notice of such change, which shall include information detailing the purpose for and elements of such change. Company shall cooperate with CyDex to have such change approved by all regulatory agencies having jurisdiction in the Territory at CyDex’s expense. 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 any change in the Specifications required by a regulatory agency necessitates changes to the terms of this Agreement, the parties shall negotiate such changes in good faith. All direct costs associated with a Specification change shall be borne by CyDex, provided, however, if a regulatory agency requires a change to the Specifications where such change is specific to Captisol as implemented in the Licensed Product, then Company shall be responsible for the costs incurred to generate such unique, modified Specifications. At Company’s request, and if the change in Specification is discretionary for CyDex and not required by a regulatory agency, CyDex shall continue to supply Captisol meeting the pre-change Specification for up to [***] after Company’s receipt of written notice of such change.

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term; provided that such change has no adverse effect or consequence on Proteolix’ development or commercialization of the Product including, for example, an effect or consequence that requires Proteolix to conduct any clinical study requested by the FDA or other regulatory agency. Any change in the Specifications that would have an adverse effect or consequence on Proteolix’ development or commercialization of the Product will require Proteolix’ prior written consent. In such eventthe event that CyDex desires to change the Specifications, CyDex shall provide to Company give Proteolix at least [[ **** ] written notice of such change, which shall include information detailing the purpose for and elements of such changedays notice. Company CyDex shall cooperate with CyDex Proteolix to have such any change approved by all the FDA and other regulatory agencies having jurisdiction in the Territory at CyDex’s expensejurisdiction. In addition, if any the event that the FDA or another regulatory agency having jurisdiction requires CyDex Proteolix to implement any changes to the Specifications, CyDex shall use all reasonable efforts to make such changes. If CyDex shall promptly advise Proteolix as to any lead-time changes or other terms that may result from a change to the Specifications, including but not limited to price adjustments necessary to enable CyDex to recover costs it actually incurred for materials already purchased by CyDex expressly for Proteolix, its Affiliates or Sublicensees and rendered unusable by a change in the Specifications required requested by a Proteolix or as necessary to comply with government regulatory agency necessitates changes requirements with respect to the terms of this Agreement, the parties shall negotiate such changes in good faith. All direct costs associated with a Specification change shall be borne by CyDex, provided, however, if Product If a regulatory agency requires a change to the Specifications where such change is specific to Captisol as implemented in CAPTISOL and not specific to the Licensed Product, Product then Company CyDex shall be responsible for the costs incurred to generate such unique, modified Specifications. At Company’s request, and if the change in Specification is discretionary for CyDex and not required by a regulatory agency, CyDex shall continue to supply Captisol meeting the pre-change Specification for up to [***] after Company’s receipt of written notice of such change.

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term. In such event, CyDex shall provide to Company at least *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. [***] written notice of such change, which shall include information detailing the purpose for and elements of such change. Company shall cooperate with CyDex to have such change approved by all regulatory agencies having jurisdiction in the Territory at CyDex’s expense. 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 any change in the Specifications required by a regulatory agency necessitates changes to the terms of this Agreement, the parties shall negotiate such changes in good faith. All direct costs associated with a Specification change shall be borne by CyDex, provided, however, if a regulatory agency requires a change to the Specifications where such change is specific to Captisol as implemented in the Licensed Product, then Company shall be responsible for the costs incurred to generate such unique, modified Specifications. At Company’s request, and if the change in Specification is discretionary for CyDex and not required by a regulatory agency, CyDex shall continue to supply Captisol meeting the pre-change Specification for up to [***] after Company’s receipt of written notice of such change.