Production Runs Sample Clauses

Production Runs. (a) Immunex and MedImmune understand and agree that, within the sole discretion of MedImmune, MedImmune may release Synagis Contract Runs to BIP but that MedImmune is under no obligation to release any Synagis Contract Runs to BIP unless MedImmune has obtained approval from the FDA to implement the EYP at MedImmune's Frederick, Maryland manufacturing facility, and MedImmune, within its sole discretion, has determined that certain Synagis Contract Runs are not needed for MedImmune's commercial needs for Synagis. In such event, the obligation to release Synagis Contract Runs to Immunex shall only extend to those Synagis Contract Runs as to which MedImmune within its sole discretion has determined are not needed by MedImmune for MedImmune's commercial needs for Synagis. (b) MedImmune and Immunex agree that it is an important aspect of this Agreement that Immunex and BIP be made aware of potential Unused Synagis Runs as soon as possible. MedImmune agrees to notify Immunex of the scheduling of Synagis Contract Runs and to promptly notify Immunex when MedImmune decides to release or is obligated to release Synagis Contract Runs. Immunex and MedImmune each agree to use reasonable efforts to communicate with and work with each other and BIP in order to avoid any unnecessary delay in allowing Immunex to start an Enbrel Run as a result of the transfer of any Unused Synagis Run hereunder. (c) The parties understand and agree that MedImmune is under no obligation to ensure that BIP will allot Transferred Synagis Runs to Immunex and MedImmune has no liability to Immunex in the event that Transferred Synagis Runs are not alloted to Immunex.
Production Runs. Subject to Section 2.2.3, BI Austria shall carry out three (3) production runs of PRODUCT in order to obtain APPROVAL in the US as a cGMP manufacturer of BBS, and to have BI Pharma KG obtain APPROVAL in the US as a cGMP manufacturer of PRODUCT. BBS and PRODUCT derived from these runs shall be used for evidencing comparability between the GENENTECH PRODUCT and the BI PRODUCT. The costs of these runs are listed in EXHIBIT 11 and shall be borne by InterMune.
Production Runs. As a part of the SERVICES and subject to Section 2.2.4, BI Austria shall carry out the necessary number of production runs of DRUG PRODUCT in order to obtain APPROVAL in the US as a cGMP manufacturer of DRUG SUBSTANCE (known as “conformance batches” or “conformance lots”), and to have BI Pharma obtain APPROVAL in the US as a cGMP manufacturer of DRUG PRODUCT. DRUG SUBSTANCE and DRUG PRODUCT derived from these runs shall be used for evidencing comparability between the AMGEN PRODUCT and the DRUG PRODUCT. The Parties anticipate that at least three (3) such production runs will be necessary for such purposes. For such production runs, BI Austria shall provide to InterMune access to or copies of those QUALITY REQUIREMENTS FOR MANUFACTURING TRANSFERS listed in Exhibit 8.
Production Runs. Promptly following the completion of an Engineering Run (or as otherwise agreed by the Parties in writing), and sign-off by the Parties on the Product Specifications to be used for the Production Run(s), manufacture of Product by Paragon will commence under this Agreement in the form of one or more Production Runs as specified in the Project Plan (or as otherwise agreed in writing by the Parties), and at the scale set forth in the Project Plan. The Parties agree that Paragon, in discussion with Client, will organize the scheduling of Production Runs to maximize Paragon’s operational schedule, including scheduling the Runs so as to constitute a campaign of two or more Runs, occurring in sequence, and without planned interruption for suite changeover or modifications to the Master Manufacturing Record, provided that such scheduling shall be subject to suite availability and Paragon’s other scheduling needs. However, Production Runs will be scheduled to ensure delivery of Product in accordance with the Project Plan (including modifications that may be made pursuant to Section 2.4 if agreed to by Paragon without any change in delivery schedule).
Production Runs. Unless otherwise conspicuously stated in a purchase order accepted and signed by Seller, the minimum quantity in any production lot shall be 25 wafers. To protect confidential information, United Microelectronics Corporation (“UMC”) and PIXELPLUS CO., LTD. (“Company”) agree:
Production Runs. Pilot Runs, Hot Runs, etc. Exhibits a and B set forth the ------------------------------------------ terms applicable to Wafer Cycle Time, Pilot Runs, Hot Lots, Production Runs and On Hold. 3 ORDER, DELIVERY, PRICING AND PAYMENT TERMS 3.1 Forecasts --------- 3.1.1 During the first seven calendar days of each month, Buyer will provide to Seller by facsimile or other electronic communication a written rolling forecast of its wafer capacity requirements from Seller's facilities for the next twelve full calendar months (each a "Buyer Forecast") (provided however that forecasts for the seventh and later months are for reference only and not binding on either party). 3.1.1.1 Each such Buyer Forecast shall show the quantity of wafer outs and the specific technology and/or process for the wafers listed. Buyer shall make good faith efforts to ensure that all such Buyer Forecasts are reasonable estimates of its anticipated needs. Subject to this obligation, and except as expressly stated in this Section 3.1.1 and/or in a written capacity quotation, all such Buyer Forecasts (and any responses to them) will be for planning purposes only, and will not create any obligation to purchase and/or sell. 3.1.1.2 Each such Buyer Forecast shall constitute a commitment by the Buyer to purchase a minimum of the following percentages of the amounts indicated: --------------------------------------------------------------------------------------------------------- Month in the forecast First month Second month of Third month Fourth month Fifth & sixth of forecast forecast of forecast of forecast months --------------------------------------------------------------------------------------------------------- Minimum percentage commitment for 100% 100% 100% 75% 50% amounts forecast for that month --------------------------------------------------------------------------------------------------------- 3.1.1.3 Seller will provide a written response to each Buyer forecast within two weeks of Seller's receipt. Subject to Section 3.1.2 below and the other terms set forth in this Agreement, Seller's response shall accept the quantities in the applicable months to the extent they are less than or equal to those accepted by Seller for the applicable month(s) pursuant to prior written agreement and/or forecasts. Seller's response may accept and/or reject in whole or in part any additional forecast quantities for those months. 3.1.2 To the extent that any forecast from Buyer pursuant to Section...

Related to Production Runs

  • Production Phase contract period in which the Development and the Production are to be performed.

  • Production Lessee shall, subject to applicable laws, regulations and orders, operate and produce all ▇▇▇▇▇ upon the leased land so long as the same are capable of producing in paying quantities, and shall operate the same so as to produce at a rate commensurate with the rate of production of ▇▇▇▇▇ on adjoining lands within the same field and within the limits of good engineering practice, except for such times as there exist neither market nor storage therefore, and except for such limitations on, or suspensions of, production as may be approved in writing by Lessor. Lessee shall be responsible for adequate site security on all producing properties.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Interconnection Customer (1) Interconnection Customer shall construct and, unless otherwise indicated, shall own, the following Interconnection Facilities: None (2) In the event that, in accordance with the Interconnection Construction Service Agreement, Interconnection Customer has exercised the Option to Build, it is hereby permitted to build in accordance with and subject to the conditions and limitations set forth in that Section, the following portions of the Transmission Owner Interconnection Facilities which constitute or are part of the Customer Facility: None Ownership of the facilities built by Interconnection Customer pursuant to the Option to Build shall be as provided in the Interconnection Construction Service Agreement.

  • Plant The expression ‘Plant’ as used in the tender papers shall mean every temporary accessory necessary or considered necessary by the Engineer to execute, construct, complete and maintain the work and all altered, modified, substituted and additional works ordered in the time and the manner herein provided and all temporary materials and special and other articles and appliance of every sort kind and description whatsoever intended or used therefore.