Prefilled Syringe definition

Prefilled Syringe means a device that is approved by the federal food and drug administration, that contains a dose of epi- nephrine, and that is used for the manual injection of epinephrine into the human body to prevent or treat a life−threatening allergic reaction.
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Prefilled Syringe means the prefilled syringe containing the formulated Drug for incorporation into the Device, as further set forth in the Product Specifications;
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Prefilled Syringe means the prefilled syringe containing the formulated Drug for incorporation into the Device.
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Examples of Prefilled Syringe in a sentence

  • Medical Emergency Supplies: • Antihistamines (diphenhydramine [Benadryl], hydroxyzine [Atarax, Vistaril], and syringes if needed) • Automated External Defibrillator (AED) • Cell Phone or Land Line to Call 911 • Emergency First Aid Kit • Epinephrine in Prefilled Autoinjector Or Prefilled Syringe (various doses), prepackaged syringes, vials, or ampules (Epi-pens).

  • Summary of Product Characteristics APO-go ampoules 10mg/ml, APO-go Pen 10mg/ml Solution for Injection, APO-go PFS 5mg/ml Solution for Infusion in Pre-filled Syringe, updated 03 Jul 2018.

  • KHK shall be responsible for performing (i) CMC activities including manufacturing, stability, tech transfer and lab study, and (ii) clinical and regulatory activities necessary to obtain the regulatory approval for the Pre-filled Syringe in the European Core Territory, in accordance with the attached Exhibit A.

  • Up and until the Profit Share Transition Date, UGNX shall be responsible for performing certain clinical and regulatory activities necessary to obtain the Marketing Approval for the Pre-filled Syringe in the U.S., including the Human Factor Engineering (HFE) study, in accordance with the attached Exhibit A (the “UGNX Activities”).

  • In case both Parties agree to Develop Pre-filled Syringe in Canada, the Parties may seek Marketing Approval of Pre-filled Syringe in Canada.

  • In case of a major change in budget of the UGNX Activities (exceeding [***] of the approved budget), or a major change in the Timeline ([***]), the JSC shall review and approve the revised budget, Timeline or Pre-filled Syringe Development plan in the U.S. The JSC’s decision will be made in accordance with Section 3.5, provided that [***] will have the authority to make the final decision with regards to [***], other than the [***].

  • Parties estimate the cost plus [***] per device (exclusive of the cost of the Prefilled Syringe supplied by Lumara).

  • Antares will work with Lumara to integrate the Device, Drug and Prefilled Syringe into a Product for commercial sale.

  • Lumara or its designee will be responsible for manufacture and formulation of any Drug and the Prefilled Syringe for assembly with the Device into the Product by Antares and for final Product release for sale.

  • In connection with the Prepared Syringes Agreement, the parties entered into an Indemnification Agreement Addendum to the Prefilled Syringe Agreement of May 9, 1998 (the "Indemnification Agreement"), which itself contained an Addendum to the Indemnification Agreement which replaced paragraph 3 of the Indemnification Agreement dealing with Sabratek's duty to indemnify Coram.