Modified Specifications Sample Clauses

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.
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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.
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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.
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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.
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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).
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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.
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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
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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.
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Modified Specifications 
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Related to Modified Specifications

  • DAF Specifications Developer shall submit initial specifications for the DAF, including System Protection Facilities, to Connecting Transmission Owner and NYISO at least one hundred eighty (180) Calendar Days prior to the Initial Synchronization Date; and final specifications for review and comment at least ninety (90) Calendar Days prior to the Initial Synchronization Date. Connecting Transmission Owner and NYISO shall review such specifications to ensure that the DAF are compatible with the technical specifications, operational control, and safety requirements of the Connecting Transmission Owner and NYISO and comment on such specifications within thirty (30) Calendar Days of Developer’s submission. All specifications provided hereunder shall be deemed to be Confidential Information.

  • The Specifications The Specifications are that portion of the Contract Documents consisting of the written requirements for materials, equipment, systems, standards and workmanship for the Work, and performance of related services.

  • Drawings and Specifications 9.1 A complete list of all Drawings that form a part of the Contract Documents are to be found as an index on the Drawings themselves, and/or may be provided to Developer and/or in the Table of Contents. 9.2 Materials or Work described in words that so applied have a well-known technical or trade meaning shall be deemed to refer to recognized standards, unless noted otherwise. 9.3 Trade Name or Trade Term It is not the intention of the Contract Documents to go into detailed descriptions of any materials and/or methods commonly known to the trade under “trade name” or “trade term.” The mere mention or notation of “trade name” or “trade term” shall be considered a sufficient notice to Developer that it will be required to complete the work so named, complete, finished, and operable, with all its appurtenances, according to the best practices of the trade. 9.4 The naming of any material and/or equipment shall mean furnishing and installing of same, including all incidental and accessory items thereto and/or labor therefor, as per best practices of the trade(s) involved, unless specifically noted otherwise. 9.5 Contract Documents are complementary, and what is called for by one shall be binding as if called for by all. As such, Drawings and Specifications are intended to be fully cooperative and to agree. However, if Developer observes that Drawings and Specifications are in conflict with the Contract Documents, Developer shall promptly notify District and Architect in writing, and any necessary changes shall be made as provided in the Contract Documents. 9.6 Figured dimensions shall be followed in preference to scaled dimensions, and Developer shall make all additional measurements necessary for the work and shall be responsible for their accuracy. Before ordering any material or doing any work, each Developer shall verify all measurements at the building and shall be responsible for the correctness of same. 9.7 Should any question arise concerning the intent or meaning of the Contract Documents, including the Plans and Specifications, the question shall be submitted to the District for interpretation. If a conflict exists in the Contract Documents, these Construction Provisions shall control over the Facilities Lease, which shall control over the Site Lease, which shall control over Division 1 Documents, which shall control over Division 2 through Division 49 documents, which shall control over figured dimensions, which shall control over large-scale drawings, which shall control over small-scale drawings. In no case shall a document calling for lower quality and/or quantity of material or workmanship control. However, in the case of discrepancy or ambiguity solely between and among the Drawings and Specifications, the discrepancy or ambiguity shall be resolved in favor of the interpretation that will provide District with the functionally complete and operable Project described in the Drawings and Specifications. 9.8 Drawings and Specifications are intended to comply with all laws, ordinances, rules, and regulations of constituted authorities having jurisdiction, and where referred to in the Contract Documents, the laws, ordinances, rules, and regulations shall be considered as a part of the Contract Documents within the limits specified. 9.9 As required by Section 4-317(c), Part 1, Title 24, CCR: “Should any existing conditions such as deterioration or non-complying construction be discovered which is not covered by the DSA-approved documents wherein the finished work will not comply with Title 24, California Code of Regulations, a construction change document, or a separate set of plans and specifications, detailing and specifying the required repair work shall be submitted to and approved by DSA before proceeding with the repair work.”

  • General specifications For the purpose of this Regulation, the vehicle shall fulfil the following requirements:

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Plans and Specifications Tenant shall be solely responsible for the preparation of the final architectural, electrical and mechanical construction drawings, plans and specifications (called “plans”) necessary for Tenant to construct the Premises for Tenant’s occupancy, which plans shall be subject to approval by Landlord’s architect and engineers and shall comply with their reasonable requirements to avoid aesthetic or other conflicts with the design and function of the balance of the Building. Landlord’s approval is solely given for the benefit of Landlord, and neither Tenant nor any third party shall have the right to rely upon Landlord’s approval of Tenant’s plans for any purpose whatsoever other than that Landlord does not object thereto under this Lease. Landlord’s architects and engineers shall respond (with approval or disapproval) to any plan submission by Tenant within 8 business days after Landlord’s receipt thereof. If Landlord fails to respond to any such submission within such 8 business day period, which failure continues for more than 2 business days after Tenant gives Landlord a written notice (the “Deemed Approved Notice”) advising Landlord that such plan submission shall be deemed approved within 2 business days of Landlord’s receipt of the Deemed Approved Notice, then such plan submission shall be deemed approved hereunder. The Deemed Approved Notice shall, in order to be effective, contain on the first page thereof, in a font at least twice as large as the font of any other text contained in such notice, a legend substantially as follows: “FAILURE TO RESPOND TO THIS NOTICE WITHIN TWO (2) BUSINESS DAYS AFTER RECEIPT HEREOF SHALL CONSTITUTE LANDLORD’S APPROVAL OF SUBMITTED PLANS.” In the event Landlord’s architect’s or engineers’ approval of Tenant’s plans is withheld or conditioned, Landlord shall send prompt written notification thereof to Tenant and include a reasonably detailed statement identifying the reasons for such refusal or condition, and Tenant shall promptly have the plans revised by its architect to incorporate all reasonable objections and conditions presented by Landlord and shall resubmit such plans to Landlord. Landlord’s architects and engineers shall respond (with approval or disapproval) to any plan re-submission by Tenant within 8 business days after Landlord’s receipt thereof. Such process shall be followed until the plans shall have been approved by Landlord’s architect and engineers without unreasonable objection or condition. Without limiting the foregoing, Tenant shall be responsible for all elements of the design of Tenant’s plans (including, without limitation, compliance with law, functionality of design, the structural integrity of the design, the configuration of the Premises and the placement of Tenant’s furniture, appliances and equipment), and Landlord’s approval of Tenant’s plans shall in no event relieve Tenant of the responsibility for such design. Tenant agrees it shall be solely responsible for the timely preparation and submission of all such plans and for all elements of the design of such plans and for all costs related thereto. (The word “architect” as used in this Section 3.2 shall include an interior designer or space planner.) Tenant shall reimburse Landlord Landlord’s reasonable out-of-pocket expense incurred in connection with the review of Tenant’s plans.

  • Specifications That part of the Contract Documents consisting of written requirements for materials, equipment, systems, standards, and workmanship as applied to the Work, and certain administrative requirements and procedural matters applicable thereto. The term "Specifications" shall also include all written matter in the Project Manual or on the drawings and any Addenda or Change Orders thereto.

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Packing Specifications 7.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

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