Starting Materials. Adams shall deliver the Starting Materials to Cardinal free of charge xx xhe Facility. Any customs duties and the like arising from importation of any Starting Material to the Facility shall be borne by Adams. The risk of loss or damage of such Starting Materials shall rexxxx with Adams until the Starting Materials are received at the Facility, at wxxxx time risk of loss or damage to the Starting Materials shall shift to Cardinal. Cardinal shall be responsible for any loss or damage to the Starting Materials while in Cardinal's custody other than as set forth herein. Adams shall be compensated for losses of any Starting Materials beyonx xxxeed upon yield tolerances, in an amount equal to Adams's actual net cost to acquire such Starting Materials.
Starting Materials. 6.1.1 Water
Starting Materials. All starting materials shall be either supplied by Novartis or Unigene, or purchased by Unigene from suppliers approved by Novartis. All applicable products or raw materials used by Unigene in Manufacturing shall meet the requirements of all then-current EU Directives concerning Transmissible Spongifoam Encephalopathy (TSE). This includes all appropriate documentation and TSE Questionnaire being included with the material.
Starting Materials. Within forty-five (45) days of receipt by Cayman of a bulk or pre-shipment sample of a starting material provided by Aerie or an Aerie Vendor, Cayman shall perform quality control procedures to verify that all such starting materials conform fully to the specifications therefore and are otherwise suitable for use in the manufacture of Product. If Cayman determines that any starting materials fail to conform to their Specifications or are otherwise unsuitable for use in the manufacture of Product, Cayman shall notify Aerie and the vendor immediately (and, in any event, within two (2) business days of such determination), and shall provide Aerie with test results, representative samples, and any other evidence necessary to demonstrate such non-conformance or unsuitability, if requested. Cayman shall properly store and maintain all conforming starting materials to ensure they remain in compliance with Specifications and suitable for manufacture of Product. In the event a starting material from Aerie or an Aerie Vendor is rejected by Cayman, Aerie shall arrange for the return and replacement of such material and all such activities and related expenditures for such activities are at the expense of Aerie.
Starting Materials. The active ingredient or excipients used in the manufacture of a PRODUCT.
Starting Materials. 3.3.1 All Raw Materials required for the Manufacture of Product shall be acquired by NxStage from Third Parties. Axxxxx shall be promptly notified in writing of any changes in any Raw Materials or a change in suppliers which occurs after the Effective Date.
3.3.2 All Fiber Bundles required for the Manufacture of Product shall be provided by Axxxxx to the Plant in such quantity and quality, at such times, and in accordance with the relevant Specifications, in order to enable NxStage to perform its obligations hereunder without delay. The Parties shall mutually agree on specific procedures for the supply and handling of Fiber Bundles prior to the first shipment thereof to NxStage.
3.3.3 Axxxxx will at all times retain title to and ownership of the Fiber Bundles. Axxxxx further represents and warrants that at all times during the term of this Agreement, the supplier of the Fiber Bundles shall distinguish the Fiber Bundles through some visual means that are readily apparent to the naked eye so that NxStage employees and representatives can easily observe the difference between the Fiber Bundles and other fiber bundles routinely used by NxStage in the manufacture of filters at its Plant. NxStage will provide within the Plant an area or areas where the Fiber Bundles are segregated in such a way as to be able at all times to clearly distinguish such materials from products and materials belonging to NxStage, or held by it for a Third Party's account. NxStage will at all times use commercially reasonable efforts to protect the Fiber Bundles from risk of loss or damage at all stages of Manufacture. NxStage will ensure that the Fiber Bundles are free and clear of any liens or encumbrances, except as may be imposed on Axxxxx or its assets by any Third Party. NxStage will within [ * ] business days notify Axxxxx if at any time it believes any Fiber Bundles have been damaged, lost or stolen.
3.3.4 NxStage agrees (a) to account for all Fiber Bundles delivered to NxStage, (b) not to provide Fiber Bundles to any Third Party without the express prior written consent of Axxxxx, (c) not to use Fiber Bundles for any purpose other than conducting the Manufacture of Products for Axxxxx hereunder, including, without limitation, not to analyze, characterize, modify or reverse engineer any Fiber Bundles or take any action to determine the structure or composition of any Fiber Bundle unless required pursuant to this Agreement, and (d) to return to Axxxxx all unused quantities of Fi...
Starting Materials. 4.1 The Customer, or if the Starting Materials are to be provided by Nova, Nova shall ensure that:
4.1.1 the specification of the Starting Materials is in accordance with the Technical Specification;
4.1.2 the Starting Materials are delivered to Nova on a Business Day;
4.1.3 the Starting Materials are delivered to Nova with full storage instructions contained in a delivery note that is attached to the outside of the packaging of the Starting Materials; and
4.1.4 the quantity of the Starting Materials is in accordance with the Quotation or the Purchase Order.
4.1.5 the Starting Materials are delivered to Nova free of charge with all duties, taxes and carriage paid.
4.2 Nova shall store the Starting Materials in accordance with the requirements of GMP and the Customer’s storage instructions as provided in accordance with clause 4.1.3.
Starting Materials. API is supplied by Lxxxxxxx Labs to BMS Anagni. BMS Anagni is responsible for inspecting and testing starting materials according to approved in-house procedures and technical specifications, which are in compliance with IND 58,362.
Starting Materials. Ash Xxxxxxx will use its best efforts at all times to maintain [ * ] supply of starting materials for the Product. Ash Xxxxxxx will provide Cerus with an itemization of the quantity of such materials maintained upon request and will promptly notify Cerus in the event of any difficulty, or anticipated difficulty, in obtaining any starting material. In the event of any termination of this Supply Agreement by Cerus, other than for breach by Ash Xxxxxxx, Cerus will be required to purchase at [ * ] cost any unexpired starting materials that are dedicated to the Products up to a maximum of [ * ]. Cerus shall also have the right to purchase any starting materials at [ * ] cost in the event of termination of this Supply Agreement for any reason other than breach by Cerus of this Supply Agreement.
Starting Materials. Atrix will order and may select to sample and test all active ingredients and excipients necessary for the Manufacture of a Product, and all packaging components, including primary and printed packaging materials (hereinafter collectively referred to as, the "Starting Materials") according to the standards set forth in the ANDA for such Product. Reduced testing/sampling may be applied as determined by Atrix. Atrix shall release the Starting Materials for processing only after the results/review of testing results, in accordance with the control procedures set forth in the ANDA are satisfactory. Atrix shall store the Starting Materials under such conditions that when used they comply in all material respects with the Specifications.
