Packaged Device definition

Packaged Device means an integral unit consisting of one or more Semiconductor Elements and/or one or more Integrated Circuit Structures having a plurality of conductive leads, conductive traces, wire bonds, conductive bumps, or solder balls associated therewith.
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Packaged Device means the Device, contained in Secondary Packaging, that is intended for use in phase 2 and/or phase 3 clinical trials.
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Packaged Device means a device packaged and tested in accordance with Analog Devices specifications, as set forth in exhibit 1.1.
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Examples of Packaged Device in a sentence

  • To permit and ensure that the Parties perform their respective regulatory compliance obligations, each Party shall provide the other Party with copies of all communications received from any Regulatory Authority concerning the Packaged Dosage Forms and/or Packaged Device within five (5) business days.

  • In the event that such inspection relates to the Packaged Device and Packaged Dosage Form, each Party shall inform and provide copies to the other Party of any critical or major observations made during any such inspection.

  • Additionally, each Party shall immediately notify the Authorized Quality Representative of the other Party of any information it receives relating to the quality of the Packaged Dosage Forms and/or Packaged Device in human clinical trials, which in the notifying Party’s judgment, relates to the Manufacturing process of the Packaged Dosage Forms and/or Packaged Device.

  • Notwithstanding anything to the contrary, such obligation of indemnity will not apply to the extent that such Damages are proximately caused by: (1) Novo Nordisk Delivery Technologies, Inc.’s material default or breach of this Agreement, including any failure to meet applicable Manufacturing Responsibilities or any defect or latent defect in a Packaged Device and/or Packaged Dosage Form as delivered by Novo Nordisk Delivery Technologies, Inc.

  • Unless otherwise agreed in writing by the Parties, all shipments shall be shipped FCA (Incoterms, 2000) the Facility at Aradigm’s expense, and Aradigm shall bear all risk of loss or damage after the Batch of Packaged Device and/or Packaged Dosage Form is shipped from the Facility.

  • Each Party shall promptly notify the other Party in writing in advance of any inspection of the Facilities by any Regulatory Agency that potentially relates to the Manufacture and supply of Packaged Device or Packaged Dosage Form.

  • Aradigm shall carry insurance against such risks, losses, and other casualties that can be reasonably insured against and in such amounts as are reasonable under the circumstances, including insurance for API, Other Excipients, and for Packaged Device and/or Packaged Dosage Form from point of shipment to destination.

  • Title to all Packaged Dosage Forms and Packaged Devices shall in each case transfer to Aradigm upon shipment of such Packaged Dosage Forms and Packaged Device from the Facility.

  • Aradigm will be responsible for all regulatory communication as pertains to Packaged Dosage Forms and/or Packaged Device.

  • The Parties have the responsibility to notify each other within twenty-four (24) hours of a situation which could be reasonably expected to result in a recall and/or withdrawal of Packaged Dosage Forms and/or Packaged Device.