API Specifications Clause Samples

The API Specifications clause defines the technical requirements and standards that an application programming interface (API) must meet within an agreement. It typically outlines the expected functionality, data formats, protocols, and performance benchmarks that the API should adhere to, and may reference detailed documentation or versioning requirements. By clearly setting these parameters, the clause ensures both parties have a mutual understanding of how the API should operate, reducing the risk of disputes and facilitating smooth integration and interoperability between systems.
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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. “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. 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. 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. 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. I. Specifications II. Specifications [*] CONFIDENTIAL TREATMENT REQUESTED
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API Specifications. What is the Real Time Balance Update I Validation feature? What are the requirements for this function to be available? The following are the current supported frameworks:
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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
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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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Related to API Specifications

  • Product Specifications (a) Supplier shall manufacture all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service ▇▇▇▇, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

  • 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.

  • 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.

  • 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.