Api Specification Changes Sample Clauses

Api Specification Changes. (a) Amarin Requested Changes. During the Term, except as set forth in Section 5.2(c), Amarin shall not be entitled to change the API Specifications related to Chemport’s performance of its obligations hereunder related to API unless it receives the Consent of Chemport, which Consent shall not be unreasonably withheld or delayed. If Amarin requests, and Chemport approves, a discretionary change to the API Specifications, Chemport shall make all revisions to the API Specifications requested by Amarin. Amarin retains the right and responsibility for final approval of the API Specifications. Amarin shall pay Chemport all documented reasonable amounts incurred in implementing a change to the API Specifications requested by Amarin under this Section 5.2(a). For all changes to the API Specifications requested by Amarin pursuant to this Section 5.2, Amarin shall, in its discretion, following consultation with Chemport, if reasonably practicable, either (i) perform, or arrange for the performance of, all development work in connection therewith or (ii) have Chemport perform such development work at the Facility at Amarin’s expense. For the avoidance of doubt, Section 5.2(a)(i) does not give Amarin any right to use or disclose (A) any Chemport Intellectual Property (except as may be permitted by any express license from Chemport), or (B) any Chemport Confidential Information (except as may be permitted under Article XIII hereof). Chemport agrees to use commercially reasonable efforts to minimize its costs associated with any API Specification change. At the request of Amarin, Chemport shall evaluate the estimated costs and timing of potential revisions to the API Specifications.
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Api Specification Changes. (a) Amarin Requested Changes. Amarin shall be entitled to change the API Specifications from time to time and, upon consent of Equateq, which shall not be unreasonably withheld or delayed, Equateq shall make all revisions to the API Specifications requested by Amarin, but reserves the right to adjust the API Price to the extent the changes to the API Specifications cause an increase or decrease in Equateq’s cost of purchase of goods, manufacture, testing, packaging, storing, handling, releasing and shipping of API; provided, however, that the Parties shall endeavour to agree to any adjustment in API Price using good faith efforts prior to the implementation of revision to the API Specification and in the absence of such agreement Amarin may either accept the price adjustment as notified by Equateq or retract the request for a revision to the API Specifications. Amarin retains the right and responsibility for final approval of the API Specifications prior to implementation. Except to the extent Amarin-requested changes are generally applicable to the Facility or Equateq’s manufacture of other products or as otherwise provided in Section 5.2(c) below, Amarin shall pay Equateq the documented reasonable amounts incurred in implementing a change to the API Specifications requested by Amarin under this Section 5.2(a). For all changes to the API Specifications requested by Amarin pursuant to this Section 5.2, Amarin shall, in its discretion, either (i) perform, or arrange for the performance of, all development work in connection therewith, or (ii) have Equateq perform such development work at the Facility. For clarity, Amarin shall not have the right to access Equateq Intellectual Property or the Facility for purposes of performing development work pursuant to (i) in the immediately preceding sentence. At the request of Amarin, Equateq shall evaluate the estimated costs and timing of potential revisions to the API Specifications. Equateq agrees to use commercially reasonable efforts to minimize its costs associated with any API Specification change.
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Api Specification Changes 
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Related to Api Specification Changes

  • Specification Changes Upon any change in the Product Specifications, stability protocols, QC laboratory methods raw material specification or Packaging Specifications (whether initiated by Horizon or made in response to a request by sanofi-aventis that is agreed to by Horizon), including the addition of new packaging configurations, new SKUs, new formulations, or a change in either raw materials or Packaging Component supply, Horizon shall promptly advise sanofi-aventis in writing of such changes, and sanofi-aventis shall promptly advise Horizon as to any scheduling and/or price adjustments which may result from such changes. Prior to implementation of such changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Product Price for any Product which embodies such changes, (b) any amounts to be reimbursed by Horizon to sanofi-aventis as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by such changes (i.e., an adjustment to the lead time for purchase orders). Horizon shall reimburse sanofi-aventis for the mutually agreed upon reasonable expenses incurred by sanofi-aventis as a result of such changes, including, but not limited to, reimbursing sanofi-aventis for its mutually agreed validation and development costs, capital expenditure costs, costs for any Packaging Components or other materials rendered unusable as a result of such changes, and cost of required stability to support a change. If during the Term Horizon amends the Product Specifications or Packaging ***Confidential Treatment Requested MANUFACTURING AND SUPPLY AGREEMENT PAGE 7 Specifications (whether voluntarily or as required by law) so as to render obsolete quantities of the Active Ingredient, Excipients and/or Packaging Components for the Product on hand at sanofi-aventis, Horizon shall (i) accept the return of all such obsolete Active Ingredient and (ii) purchase from sanofi-aventis, at sanofi-aventis’ Acquisition Cost, all such obsolete Excipients and Packaging Components obtained by sanofi-aventis pursuant to its normal procurement policies to manufacture quantities of the Product pursuant to Horizon forecasts under Section 6.1. Sanofi-aventis’ normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of Excipients and Packaging Components corresponding to the immediately following […***…] months of Horizon’s most recent forecasted Product demand. If a change in Specifications is initiated by sanofi-aventis and approved by Horizon, any cost associated with said change shall be borne by sanofi-aventis. In the event that a change in Specifications is initiated by Horizon or driven by a regulatory or business change, the costs associated with qualification of the change shall be paid by Horizon. The amount of the change shall be reasonable and customary and subject to written approval by Horizon, such approval not to be unreasonably withheld. Sanofi-aventis, with written agreement and approval from Horizon, will be responsible for the appropriate (cGMP) destruction of any materials covered under this Article 5, and sanofi-aventis shall be reimbursed by Horizon at the reasonable and customary approved rate.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • 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.

  • 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.

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCI, whether requested by Client, requested by PCI or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Pricing). PCI shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, PCI shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. PCI reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, until such time as the parties agree to and execute the required written amendment.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Change Orders Any alteration or deviation from the Services mentioned or any other contractual specifications that result in a revision of this Agreement shall be executed and attached to this Agreement as a change order (“Change Order”).

  • 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.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Change Order (5) The Change Order is then submitted to the Project Manager who immediately processes the CO with OPC as required by Bulletin 3.5 and BGS’ Contracting Plan.

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