Modified Specifications Sample Clauses

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.

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. Sato may propose modifications to the Specifications for the Licensed Product in the Licensed Field. The JC shall discuss any such proposed modifications and the bases therefor. If the JC approves such modification, then the Specifications shall be updated as approved by the JC (“Modified Specifications”). For clarity, Novan shall have no obligation to modify the specifications for Licensed Product in the Licensed Field outside the Licensed Territory if any Modified Specifications are adopted for the Licensed Product in the Licensed Field in the Licensed Territory.

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term. In the event that CyDex modifies the Specifications, CyDex shall give Company at least [***] notice before implementation of such change and shall use good faith commercially reasonable efforts to continue to supply against the original Captisol specification until Company has obtained any required amendment or other modification of the *** 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. Licensed Product regulatory approvals. [***]. In the event that any regulatory agency having jurisdiction requires CyDex to implement any changes to the Specifications for Captisol generally (and not for a Licensed Product specifically), CyDex shall use all reasonable efforts to make such changes and shall, within [***] of learning of required changes to the Specifications, advise Company as to any lead-time changes or other terms that may result from a change to the Specifications.

Modified Specifications. CyDex shall have the right to change the Specifications from time to time during the Term. In such event, CyDex shall give Company at least [**] days notice of such change and, if requested by Company, shall provide to Company the right to purchase an amount of CAPTISOL not greater than a [**]-year supply prior to such change in Specifications if such change impacts the Company's regulatory efforts related to the Licensed Product or commercial sale of the Licensed Product. Company shall cooperate with CyDex to have such change approved by all regulatory agencies having jurisdiction. In addition, if any regulatory agency having jurisdiction or cGMP requires CyDex to implement any changes to the Specifications, CyDex shall use all reasonable efforts to make such changes. In each case, CyDex shall promptly (but in all cases within a reasonable period of time in advance of the anticipated implementation of such change to reasonably allow Company to evaluate the consequences of such change) advise Company as to any lead-time changes or other terms that may result from a change to the Specifications. CyDex shall be responsible for all costs incurred by CyDex arising from any change requested by CyDex and not otherwise required by cGMP or any regulatory authority (other than Company's cost to purchase any additional supply of CAPTISOL). Company shall be responsible for all costs incurred by CyDex (including without limitation costs incurred for materials already purchased by CyDex or its Third-Party Manufacturer expressly for Company, its Affiliates or Sublicensees, in each case solely to the extent that such materials can not be redeployed or sold to other customers at or above their actual cost) related to implementing any change in Specifications that is (a) requested by Company or (b) required by cGMP or any regulatory authority specifically to the Licensed Product (i.e., is not a change made generally with respect to CAPTISOL for all products using CAPTISOL as a component).

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 materially affect commercial viability of License Product or regulatory status of Licensed Product. In the event that CyDex modifies Specifications, CyDex shall give MDCO at least [***] notice of such change. MDCO shall cooperate with CyDex to have such change approved by all regulatory agencies having jurisdiction at CyDex’s own costs, including replacing Captisol already purchased by MDCO with Captisol under the new modified Specifications and reimbursing MDCO 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 [***] of learning of required changes to the Specifications, advise MDCO 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 MDCO with Captisol under the new modified Specifications and reimbursing MDCO 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 

Modified Specifications