Fill and Finish Services Sample Clauses

Fill and Finish Services. After the Effective Date, at Amylin’s reasonable request, and subject to Section 3.8, Amgen shall provide fill and finish services for up to a maximum of [*] vials of lyophilized A-100 Leptin per calendar year for [*], beginning January 1, 2006, to support Amylin’s ongoing patient and clinical trial supply obligations. Subject to the prior sentence, for the period from the Effective Date through [*] after the transfer to Amylin of the IND for A-100 Leptin, Amgen shall ship labeled A-100 Leptin vials to the existing sites of Ongoing Clinical Trials and to existing extramural research sites with active contracts. For any new clinical or research sites initiated by Amylin, Amgen will ship unlabelled A-100 Leptin vials to a label facility designated by Amylin for Amylin’s subsequent label and distribution. Beginning [*] after the transfer to Amylin of the IND for A-100 Leptin through the remainder of the period that Amgen is providing fill and finish services, Amgen will be responsible for shipping unlabelled vials of GMP A-100 Leptin to a label facility designated by Amylin; and Amylin shall be responsible for labeling and shipping A-100 Leptin vials to their final destination. Amgen and Amylin will, promptly after the Effective Date, enter into a separate quality agreement regarding such clinical supply of A-100 Leptin to Amylin, which will include, without limitation, provision of a certificate confirming that such A-100 Leptin, both bulk and finished product, was manufactured under current Good Manufacturing Practices (“GMP”). Such A-100 Leptin vials will be filled from Amgen’s existing quantity of bulk A-100 Leptin manufactured and tested according to Good Manufacturing Practices under the FDCA. Amgen shall provide such A-100 Leptin vials throughout each calendar year as generally reflected in a mutually agreed upon Tentative Schedule for Delivery of A-100 Leptin Clinical Drug Product attached as Exhibit J. The schedule attached as Exhibit J shall be subject to manufacturing capacity and availability of GMP drug substance. Each shipment of A-100 Leptin under this Section 3.3 shall be accompanied or preceded by a certificate of analysis confirming that such A-100 Leptin conforms to the specifications set forth in the Regulatory Documents. In addition, Amgen will ship the A-100 Leptin vials to a location specified by Amylin (which will be within the contiguous U.S.). Amylin will compensate Amgen for these fill and finish services at a price of [*] per vial,...
Sample 1
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Related to Fill and Finish Services

  • Customer Services Provide services and systems dedicated to customer service, including billing, remittance, credit, collections, customer relations, call centers, energy conservation support and metering.

  • Support Services Other than the assistance provided in the Information, the BNPP Entities do not offer any support services in connection with the Software.

  • Technical Services Party B will provide technical services and training to Party A, taking advantage of Party B’s advanced network, website and multimedia technologies to improve Party A’s system integration. Such technical services shall include:

  • Training Services Fiserv shall provide training, training aids, user manuals, and other documentation for Client's use as Fiserv finds necessary to enable Client personnel to become familiar with Fiserv Services. If requested by Client, classroom training in the use and operation of Fiserv Services will be provided at a training facility designated by Fiserv. All such training aids and manuals remain Fiserv's property.

  • Specific Services Without limiting the generality of the Services to be provided as set forth above, it is hereby acknowledged and agreed that Consultant will provide the following specific services:

  • TECHNICAL SUPPORT SERVICES 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").

  • Products and Services Part 2.9(a) of the Disclosure Schedule accurately identifies and describes each Company Product currently being designed, developed, manufactured, marketed, distributed, provided, licensed, or sold by the Company.

  • Hosting Services GSI shall load the Web site onto server(s) that are connected to the Internet and readily accessible via the Web through use of the Domain Names. GSI shall ensure that the Web site is functional and ready to process transactions in a reasonably efficient manner.

  • Customer Relations A. Actively promote DCP Holding Company in all Marketing, Sales, Public Relations, and Community activity.

  • 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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