IV Product definition

IV Product means any Daptomycin Product formulated for intravenous delivery, including without limitation the formulation described by the specifications set forth in a letter that Cubist has provided to Gilead prior to the Effective Date.
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IV Product means the sulopenem antibiotic being developed by Iterum for intravenous delivery.
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IV Product means the sulopenem antibiotic being developed by the Parent Guarantor for intravenous delivery.
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Examples of IV Product in a sentence

  • Kamada shall fulfill all regulatory requirements relating to the safety of the A1PI IV Product, including, but not limited to, collecting and assessing adverse events, reporting safety information (individual case safety reports and aggregate reports), literature searches, risk management activities, if warranted, responding to regulatory inquiries and conducting pharmacovigilance for the A1PI IV Product.

  • In the event the BLA Party determines that any Remedial Action with respect to the A1PI IV Product should be commenced, or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially Reasonable Efforts to conduct such Remedial Action.

  • The BLA Party shall determine whether to commence any Remedial Action with respect to the A1PI IV Product.

  • Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any party, including, without limitation, a Regulatory Authority which may affect the safety or efficacy claims of the A1PI IV Product or the continued marketing of the A1PI IV Product.

  • Kamada shall, at its discretion, have the right to attend any Xxxxxx meetings with the FDA, ISO or any other federal, state or local regulatory agency that relate to the A1PI IV Product in the Xxxxxx Territory.

  • Notwithstanding the foregoing, if Xxxxxx receives any telephonic or written or other correspondence relating to an adverse event for an A1PI IV Product in the United States or elsewhere in the Xxxxxx Territory, Xxxxxx shall use Commercially Reasonable Efforts to obtain the Minimum PV Information and shall promptly forward such Minimum PV Information to Kamada.

  • Xxxxxx shall be responsible for obtaining, and undertakes to obtain using its Commercially Reasonable Efforts, and maintaining all regulatory, administrative, and third party payor-related activities relating to pricing and reimbursement approvals for the A1PI IV Product in the Xxxxxx Territory (and any country therein).

  • In furtherance of this right, Xxxxxx agrees that it shall specifically obtain from any and all third-party or Affiliate distributors of the A1PI IV Product a right of Kamada to conduct audits of such party’s records and facilities as set forth herein.

  • In the event that Xxxxxx is not manufacturing or distributing the A1PI IV Product and is using third parties to manufacture or distribute the A1PI IV Product, Xxxxxx shall obtain all rights necessary from such third parties to enable Kamada to exercise all of its rights under this Agreement at such third party manufactures’ facilities.

  • The Parties shall report to each other all information necessary to make timely reports as required by any Regulatory Authority or other authorized authority in the Xxxxxx Territory and Kamada Territory regarding the A1PI IV Product.


More Definitions of IV Product

IV Product means the Product formulated for intravenous administration.
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IV Product means the Product in its intravenous formulation.
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IV Product means all injectable and intravenous dosage forms of Vernakalant.
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Related to IV Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.