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,...
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Related to Fill and Finish Services

  • Customer Services Customer Relationship Management (CRM): All aspects of the CRM process, including planning, scheduling, and control activities involved with service delivery. The service components facilitate agencies’ requirements for managing and coordinating customer interactions across multiple communication channels and business lines. Customer Preferences: Customizing customer preferences relative to interface requirements and information delivery mechanisms (e.g., personalization, subscriptions, alerts and notifications).

  • Telemedicine Services This plan covers clinically appropriate telemedicine services when the service is provided via remote access through an on-line service or other interactive audio and video telecommunications system in accordance with R.I. General Law § 27-81-1. Clinically appropriate telemedicine services may be obtained from a network or non- network provider, and from our designated telemedicine service provider. When you seek telemedicine services from our designated telemedicine service provider, the amount you pay is listed in the Summary of Medical Benefits. When you receive a covered healthcare service from a network or non-network provider via remote access, the amount you pay depends on the covered healthcare service you receive, as indicated in the Summary of Medical Benefits. For information about telemedicine services, our designated telemedicine service provider, and how to access telemedicine services, please visit our website or contact our Customer Service Department.

  • Support Services Rehabilitation, counselling and EAP’s. Support is strictly non- punitive, and can be accessed at anytime (self-identification of the need for help is strongly encouraged).

  • Autism Services This plan covers the following services for the treatment of autism spectrum disorders. • Applied behavior analysis when provided and/or supervised by an individual licensed by the state in which the service is rendered. See the Summary of Medical Benefits for the amount that you pay. • Physical therapy, occupational therapy, and speech therapy services when rendered as part of the treatment of autism spectrum disorder. A benefit limit will not apply to these services. • Psychological and psychiatric services, and prescription drugs are also covered. See Behavioral Health Services and Prescription Drugs and Diabetic Equipment or Supplies for additional information. Coverage for autism spectrum disorders does not affect any obligation of a school district, a state or other governmental entity to provide services to an individual under an individualized family service plan, an individualized education program, or similar services required under state or federal law. Services related to autism that are furnished by school personnel are not covered under this plan.

  • Surgery Services This plan covers surgery services to treat a disease or injury when: • the operation is not experimental or investigational, or cosmetic in nature; • the operation is being performed at the appropriate place of service; and • the physician is licensed to perform the surgery. This plan covers reconstructive surgery and procedures when the services are performed to relieve pain, or to correct or improve bodily function that is impaired as a result of: • a birth defect; • an accidental injury; • a disease; or • a previous covered surgical procedure. Functional indications for surgical correction do not include psychological, psychiatric or emotional reasons. This plan covers the procedures listed below to treat functional impairments. • abdominal wall surgery including panniculectomy (other than an abdominoplasty); • blepharoplasty and ptosis repair; • gastric bypass or gastric banding; • nasal reconstruction and septorhinoplasty; • orthognathic surgery including mandibular and maxillary osteotomy; • reduction mammoplasty; • removal of breast implants; • removal or treatment of proliferative vascular lesions and hemangiomas; • treatment of varicose veins; or • gynecomastia.

  • TRANSPORT SERVICES Upon the conclusion of such multilateral negotiations, the Parties shall conduct a review for the purpose of discussing appropriate amendments to this Agreement so as to incorporate the results of such multilateral negotiations.

  • 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: (a) administering, managing and maintaining Party A’s information application system and website system infrastructure; (b) providing system optimization plans and implementing optimization features; (c) assuring the security and reliability of the website application systems; (d) procuring, installing and supporting the relevant products produced by Party B, and providing training in the use of those products; (e) managing and maintaining all network and providing technologies to assure the reliability and efficiency thereof; (f) providing information technology services and assuring the reliable operation of the information infrastructure.

  • Training Services Training Services may include pre-packaged training Products, and/or the development or customization of training programs as requested, including Live Training, Computer Based/Multi-Media Training which encompasses Internet-Delivered Training, and/or Video Based Training.

  • Hospice Services Services are available for a Member whose Attending Physician has determined the Member's illness will result in a remaining life span of six months or less.

  • Chiropractic Services This plan covers chiropractic visits up to the benefit limit shown in the Summary of Medical Benefits. The benefit limit applies to any visit for the purposes of chiropractic treatment or diagnosis.

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