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; provided, however, that any such change shall not affect commercial viability of the Licensed Product or regulatory status or Approvals of the Licensed Product. In the event that CyDex intends to modify Specifications, CyDex shall give Spectrum at least [***] ([***]) days’ notice of such intended change and seek Spectrum’s permission which Spectrum will not withhold unless Spectrum reasonably believes such change(s) will affect commercial viability of the Licensed Product or regulatory status or Approvals of the Licensed Product. Subject to the foregoing, Spectrum shall cooperate with CyDex to have such change approved by all regulatory agencies having jurisdiction at CyDex’s own cost, including replacing Captisol already purchased by Spectrum with Captisol under the new modified Specifications and reimbursing Spectrum all costs associated with the finished product if it is no longer suitable for human use. In the event that any regulatory agency having jurisdiction requires CyDex to implement any changes to the Specifications for Captisol generally (and not for the Licensed Product specifically), CyDex shall use all reasonable efforts to make such changes and shall, within [***] ([***]) days of learning of required changes to the Specifications, advise Spectrum as to any lead-time changes or other terms that may result from a change to the Specifications at CyDex’s own costs, including replacing Captisol already purchased by Spectrum with Captisol under the new modified Specifications and reimbursing Spectrum all costs associated with the finished product if it is no longer suitable for human use. In the event that any modification to Specifications for Captisol generally (and not for the Licensed Product specifically) by CyDex leads to delay or withdrawal of Licensed Product or makes Licensed Product no longer commercially viable, Section 3.5 of this Agreement shall apply.

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term; provided, however, provided that any such change shall not affect commercial viability of to the Specifications that would require Sage to (i) conduct additional process validation or (ii) comply with additional clinical study requirements from the FDA or other major-market regulatory agencies that would be beyond that required for the Licensed Product or regulatory status or Approvals of formulated with Captisol meeting the Licensed Productunmodified Specifications, will require Sage’s prior written consent. In the event that CyDex intends desires to modify change the Specifications, CyDex shall give Spectrum Sage at least [***] ([***]) days3 months’ notice of such intended notice. If CyDex desires to change and seek Spectrum’s permission which Spectrum will not withhold unless Spectrum reasonably believes such change(s) will affect commercial viability of the Licensed Product Specifications or a regulatory status or Approvals of the Licensed Product. Subject agency requires a change to the foregoingSpecifications where such change is generally applicable to Captisol, Spectrum CyDex shall reimburse Sage for any Captisol purchased hereunder which is rendered unusable in all major markets by such change in Specifications. CyDex shall use Commercially Reasonable Efforts to cooperate with CyDex to Sage to, if necessary, have such any change approved by all the FDA and other regulatory agencies having jurisdiction at CyDex’s own cost, including replacing jurisdiction. CyDex will continue to provide Captisol already purchased by Spectrum with Captisol the unmodified Specifications under the new modified Specifications terms of this Agreement until such time that Sage has obtained any required approvals for the Specification change by the FDA and reimbursing Spectrum all costs associated with the finished product if it is no longer suitable for human useother applicable major-market regulatory agencies. In the event that any the FDA or another applicable major-market regulatory agency having jurisdiction requires CyDex Sage to implement any changes to the Specifications for Captisol generally (and not for the Licensed Product specifically)Specifications, CyDex shall use all reasonable efforts to make such changes and shall, within [***] ([***]) days of learning of required changes to the Specifications, changes. CyDex shall promptly advise Spectrum Sage as to any lead-time changes or other terms that may result from a change to the Specifications at CyDex’s own costs, including replacing Captisol Specifications. Sage shall bear the costs CyDex actually incurred for materials already purchased expressly for Sage, its Affiliates or Sublicensees and rendered unusable by Spectrum with a change in Specifications requested by Sage and agreed to by CyDex. If a regulatory agency requires a change to the Specifications where such change is not generally applicable to Captisol under but is specific to the new Licensed Product, or if Sage requests a change to the Specifications which CyDex agrees to, then Sage shall be responsible for the documented, reasonable costs incurred to generate such unique, modified Specifications and reimbursing Spectrum Specifications. In all other instances, CyDex shall bear all costs associated with any change to the finished product if it is no longer suitable for human useSpecifications. In ***Text Omitted and Filed Separately with the event that any modification to Specifications for Captisol generally (Securities and not for the Licensed Product specificallyExchange Commission Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) by CyDex leads to delay or withdrawal of Licensed Product or makes Licensed Product no longer commercially viable, Section 3.5 of this Agreement shall apply.and 230.406

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term; provided, however, provided that any such change shall not affect commercial viability of to the Specifications that would require Sage to (i) conduct additional process validation or (ii) comply with additional clinical study requirements from the FDA or other major-market regulatory agencies that would be beyond that required for the Licensed Product or regulatory status or Approvals of formulated with Captisol meeting the Licensed Productunmodified Specifications, will require Sage’s prior written consent. In the event that CyDex intends desires to modify change the Specifications, CyDex shall give Spectrum Sage at least [***] ([***]) days3 months’ notice of such intended notice. If CyDex desires to change and seek Spectrum’s permission which Spectrum will not withhold unless Spectrum reasonably believes such change(s) will affect commercial viability of the Licensed Product Specifications or a regulatory status or Approvals of the Licensed Product. Subject agency requires a change to the foregoingSpecifications where such change is generally applicable to Captisol, Spectrum CyDex shall reimburse Sage for any Captisol purchased hereunder which is rendered unusable in all major markets by such change in Specifications. CyDex shall use Commercially Reasonable Efforts to cooperate with CyDex to Sage to, if necessary, have such any change approved by all the FDA and other regulatory agencies having jurisdiction at CyDex’s own cost, including replacing jurisdiction. CyDex will continue to provide Captisol already purchased by Spectrum with Captisol the unmodified Specifications under the new modified Specifications terms of this Agreement until such time that Sage has obtained any required approvals for the Specification change by the FDA and reimbursing Spectrum all costs associated with the finished product if it is no longer suitable for human useother applicable major-market regulatory agencies. In the event that any the FDA or another applicable major- market regulatory agency having jurisdiction requires CyDex Sage to implement any changes to the Specifications for Captisol generally (and not for the Licensed Product specifically)Specifications, CyDex shall use all reasonable efforts to make such changes and shall, within [***] ([***]) days of learning of required changes to the Specifications, changes. CyDex shall promptly advise Spectrum Sage as to any lead-time changes or other terms that may result from a change to the Specifications at CyDex’s own costs, including replacing Captisol Specifications. Sage shall bear the costs CyDex actually incurred for materials already purchased expressly for Sage, its Affiliates or Sublicensees and rendered unusable by Spectrum with a change in Specifications requested by Sxxx and agreed to by CyDex. If a regulatory agency requires a change to the Specifications where such change is not generally applicable to Captisol under but is specific to the new Licensed Product, or if Sage requests a change to the Specifications which CyDex agrees to, then Sage shall be responsible for the documented, reasonable costs incurred to generate such unique, modified Specifications and reimbursing Spectrum Specifications. In all other instances, CyDex shall bear all costs associated with any change to the finished product if it is no longer suitable for human use. In the event that any modification to Specifications for Captisol generally (and not for the Licensed Product specifically) by CyDex leads to delay or withdrawal of Licensed Product or makes Licensed Product no longer commercially viable, Section 3.5 of this Agreement shall applySpecifications.

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term; provided, however, provided that any such change shall not affect commercial viability of to the Specifications that would require Sage to (i) conduct additional process validation or (ii) comply with additional clinical study requirements from the FDA or other major-market regulatory agencies that would be beyond that required for the Licensed Product or regulatory status or Approvals of formulated with Captisol meeting the Licensed Productunmodified Specifications, will require Sage’s prior written consent. In the event that CyDex intends desires to modify change the Specifications, CyDex shall give Spectrum Sage at least [***] ([***]) days’ notice of such intended notice. If CyDex desires to change and seek Spectrum’s permission which Spectrum will not withhold unless Spectrum reasonably believes such change(s) will affect commercial viability of the Licensed Product Specifications or a regulatory status or Approvals of the Licensed Product. Subject agency requires a change to the foregoingSpecifications where such change is generally applicable to Captisol, Spectrum CyDex shall reimburse Sage for any Captisol purchased hereunder which is rendered unusable in all major markets by such change in Specifications. CyDex shall use Commercially Reasonable Efforts to cooperate with CyDex to Sage to, if necessary, have such any change approved by all the FDA and other regulatory agencies having jurisdiction at CyDex’s own cost, including replacing jurisdiction. CyDex will continue to provide Captisol already purchased by Spectrum with Captisol the unmodified Specifications under the new modified Specifications terms of this Agreement until such time that Sage has obtained any required approvals for the Specification change by the FDA and reimbursing Spectrum all costs associated with the finished product if it is no longer suitable for human useother applicable major-market regulatory agencies. In the event that any the FDA or another applicable major-market regulatory agency having jurisdiction requires CyDex Sage to implement any changes to the Specifications for Captisol generally (and not for the Licensed Product specifically)Specifications, CyDex shall use all reasonable efforts to make such changes and shall, within [***] ([***]) days of learning of required changes to the Specifications, changes. CyDex shall promptly advise Spectrum Sage as to any lead-time changes or other terms that may result from a change to the Specifications at CyDex’s own costs, including replacing Captisol Specifications. Sage shall bear the costs CyDex actually incurred for materials already purchased expressly for Sage, its Affiliates or Sublicensees and rendered unusable by Spectrum with a change in Specifications requested by Sage and agreed to by CyDex. If a regulatory agency requires a change to the Specifications where such change is not generally applicable to Captisol under but is specific to the new Licensed Product, or if Sage requests a change to the Specifications which CyDex agrees to, then Sage shall be responsible for the documented, reasonable costs incurred to generate such unique, modified Specifications and reimbursing Spectrum Specifications. In all other instances, CyDex shall bear all costs associated with any change to the finished product if it is no longer suitable for human useSpecifications. In *** Certain information on this page has been omitted and filed separately with the event that any modification Commission. Confidential treatment has been requested with respect to Specifications for Captisol generally (and not for the Licensed Product specifically) by CyDex leads to delay or withdrawal of Licensed Product or makes Licensed Product no longer commercially viable, Section 3.5 of this Agreement shall apply.omitted portions. EXECUTION COPY