API Specifications Sample Clauses

API Specifications. The API Specifications set forth on Schedule 1.3 hereto are consistent with the specifications for API to be provided under the Prior Collaborations. Halozyme’s present manufacturing process has produced PH20 Drug with qualities that meet the API Specifications.
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API Specifications. The referenced API(s) must be manufactured, packaged, labeled (if necessary) and handled according to the written specifications and procedures as outlined in this agreement. Changes to the specifications shall be mutually agreed upon and approved in writing by both parties. In testing starting materials, intermediates and API(s) [***] the analytical methods requiring validation. Methods which appear in the current compendia or other recognized standard references should be written in sufficient detail to describe specific equipment and analytical parameter ranges. Product aspect methods such as appearance, color and clarity of solution shall also be written. For those analytical methods developed by Formosa, documentation supporting the development and validation of the analytical method shall be supplied upon request to NGX. Each lot of API will be sampled and tested in accordance with the agreed upon [***] procedures, Regulatory Requirements, and must meet the specifications as outlined in this agreement.
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API Specifications. What is the Real Time Balance Update I Validation feature? This functionality instructs KUBRA to validate and retrieve the latest balance from a Citizens' Web Service instead of getting the data through the Validation data files Citizens sends to KUBRA. What are the requirements for this function to be available? A Web Service from Citizens should be available for KUBRA to consume that will return the following essential information: Amount Due Due Date Bill Date Account Type (Commercial vs Residential), if applicable Is Cash Only (User cannot pay via Bank Account), if applicable XXXXXxxxx then be creating an interface (internally referred to as Adapter) that will allow seamless connectivity between Citizens' Web Service and KUBRA. The following are the current supported frameworks: Restful Web API (Preferred method) Windows Communication Foundation (WCF) Other frameworks/protocols may be supported but may require review and additional development time XXXX 2.0. KUBRA I If Citizens does not have an existing Web Service available, it is recommended to Citizens to build a Restful Web AP/ that will accept and return parameters as defined on the KUBRA's Service Contract. The preferred mode of authentication is through API keys passed through the request header. In doing so, development time of the interface (or adapter) will be greatly reduced as this may allow KUBRA to just utilize the existing Standard Adapter to communicate with Citizens' Web Service. In this scenario, the following illustrates what we are expecting to be sent out and received as a response. Request (KUBRA to Citizens' Web Service) - Validation Fields Object Definition public interface IValidationField { string FieldName { get; set; } string Value { get; set; }
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API Specifications. “API Specifications” shall mean the specifications for the API set forth in the respective Product Addendum in ANNEX 1, as determined in accordance with the analytical methodology related thereto, and may be updated from time to time in accordance with Section 5.6.1.
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API Specifications. Changes to the API Specifications may only be made in accordance with the procedure delineated in the Quality Agreement, that notwithstanding, in no case may a change to the API Specifications be made upon less than eighteen (18) months prior written notice to Par and without Par’s written consent, which shall not be unreasonably withheld, unless such change is of the nature that does not require a filing with, approval by or notification to, any Regulatory Authority. Biocon agrees that it will promptly notify Par of any and all changes to the API Specifications and/or manufacturing process.
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API Specifications. “API Specifications” shall mean the specifications for Active Pharmaceutical Ingredient set forth in the Quality Agreement.
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API Specifications. ViroPharma represents and warrants that all Active Pharmaceutical Ingredient supplied to OSG under this Agreement shall conform to the API Specifications.
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API Specifications. The Parties have agreed upon the Specifications for the API as set forth herein. The Parties shall agree upon any modifications to the Specifications set forth herein in writing.
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API Specifications. The parties have agreed upon all those applicable specifications for the API as set forth hereunder. The parties shall agree upon any modifications to the specifications here below in writing. · Include packaging specifications · Include minimum shelf life · Include analytical methods, product specifications, product impurities, degradation products, and reference standards provided by Nabriva Schedule B
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Related to API Specifications

  • 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.

  • 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.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • 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.

  • 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.

  • 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.

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

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