Master Batch Sample Clauses

Master Batch process documentation will be prepared and approved by GalaGen as per its normal procedures. The Parties agree that deviations from master Batch process documentation may be necessary from time to time. Such deviations shall be discussed with Wyeth-Ayerst before any proposed shipment of the Ingredient. Individual Batch process documentation shall be photocopied from the approval master and issued for each Batch as per GalaGen's or its sub-contractor's routine system. Original Batch records will be filed securely by GalaGen or its sub-contractor. GalaGen or GalaGen's sub-contractor will perform all in-process control tests demanded by the approved Batch process.
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Master Batch. RECORD (MBR) shall mean the formal set of instructions for Production of Drug Product. The MBR shall be developed and maintained in ALTHEA’s standard format by AXXXXX, using CLIENT’s master formula and technical support.

Related to Master Batch

  • Certificate of Analysis Seller shall provide a certificate of analysis and other documents as defined in the Quality Agreement for any Product to be released hereunder, in a form in accordance with the cGMPs and all other applicable Regulatory Requirements and Product Specifications and as shall be agreed upon by the parties. For any batch that initially failed to meet any Product Specification, the certificate of analysis shall document the exception. Products that do not meet dissolution specifications at USP Stage I and II testing shall not be accepted by Buyer (and such requirement shall be included in the Product Specifications/Quality Manual).

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Data Loss Prevention Transfer Agent shall implement a data leakage program that is designed to identify, detect, monitor and document Fund Data leaving Transfer Agent’s control without authorization in place.

  • Shipment If any of the Major Components associated with any Unit is not Shipped on or before (with the prior approval of the Buyer) the Scheduled Major Component Shipment Date set forth in Attachment 1 for reasons attributable to the Seller and not excused elsewhere in this Contract, the Seller shall pay as liquidated damages, and not as a penalty, a sum calculated in accordance with the table below for each Unit for each day of delay after the Scheduled Major Component Shipment Date as set forth in Attachment 1 until actual Shipment of the last Major Component for such Unit: Days after Scheduled Major Component Shipment Date Liquidated Damages (per day or partial day) *** *** *** *** *** *** Such liquidated damages, if any, shall be computed based on the date of Shipment of the last Major Component for a given Unit and such computations shall disregard any part of or accessory to the Major Component which may be shipped separately and arrive later unless such part of or accessory to the Major Component is necessary for the installation of the Major Component.

  • Certificates of Analysis Illumina shall, once made available for all TG Consumables as part of Illumina’s standard commercial offering for TG Consumables, provide a Certificate of Analysis for each lot of TG Consumables sold to Customer under this Agreement.

  • Facility Type    Call Sign    Exp Date TV Broadcast Station License WBRE-TV 08/01/2007 (Channel 28, Xxxxxx-Xxxxx, Pennsylvania) DTV Facility WBRE-DT 08/01/2007 (Channel 11, Xxxxxx-Xxxxx, Pennsylvania) TV Translator Station License W24BL 08/01/2007 TV Translator Station License W30AN 08/01/2007 TV Translator Station License W51BP 08/01/2007 TV Translator Station License W64AL 08/01/2007 Transmit-Only Earth Station License E910642 11/01/2011 Transmit-Receive Earth Station License E020058 05/03/2017 TV Pickup KA35201 08/01/2007 TV Pickup KA35245 08/01/2007 TV Pickup KA74870 08/01/2007 TV Pickup KC62824 08/01/2007 Broadcast Auxiliary KF5726 08/01/2007 TV Studio Transmitter Link KGH66 08/01/2007 R/P Base Mobile System KGU973 08/01/2007 TV Pickup KK4138 08/01/2007 TV Pickup KL2535 08/01/2007 TV Pickup KP4407 08/01/2007 R/P Base Mobile System KQB618 08/01/2007 TV Pickup KR7688 08/01/2007 TV Pickup KR7693 08/01/2007 TV Pickup KR7771 08/01/2007 TV Pickup KS2001 08/01/2007 TV Pickup KY2899 08/01/2007 R/P Mobile KY5608 08/01/2007 TV Studio Transmitter Link KZO21 08/01/2007 TV Intercity Relay WFW575 08/01/2007 TV Intercity Relay WGI290 08/01/2007 TV Intercity Relay WHB674 08/01/2007 TV Intercity Relay WLI324 08/01/2007 TV Intercity Relay WLI325 08/01/2007 TV Intercity Relay WLI337 08/01/2007 TV Intercity Relay WMF322 08/01/2007 TV Intercity Relay WMF323 08/01/2007

  • Check and complete if Transferee will take delivery of a beneficial interest in the IAI Global Note or a Restricted Definitive Note pursuant to any provision of the Securities Act other than Rule 144A or Regulation S. The Transfer is being effected in compliance with the transfer restrictions applicable to beneficial interests in Restricted Global Notes and Restricted Definitive Notes and pursuant to and in accordance with the Securities Act and any applicable blue sky securities laws of any state of the United States, and accordingly the Transferor hereby further certifies that (check one):

  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

  • WHEXXXX xs xxxx of a plan of reorganization, RESTART PARTNERS, L.P., a Delaware Limited Partnership ("Restart"), may acquire an ownership interest in Elsinore Corporation ("Elsinore") or the Four Queens, Inc. ("FQI");

  • Contract Price The Owner agrees to pay the Contractor for the full and faithful performance of the Work, including all applicable taxes, and the Contractor agrees to accept such payment as full and just compensation therefor. The Work is to be done on a time and material basis as it is set forth in the “Scope of Work” referenced in Section 2 above, and the total estimated cost for the Work is ___________________________________________ DOLLARS AND __/100 ($________.__) (the “Contract Price”) in current funds subject to additions and deductions for changes and/or charges as may be agreed upon in writing pursuant to this Agreement.

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