COBI Product definition

COBI Product means a formulated and finished pharmaceutical product containing COBI as its sole active pharmaceutical ingredient.
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Examples of COBI Product in a sentence

  • Licensee agrees that it will not administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for a COBI Product from the FDA.

  • All TAF Product, TAF Combination Product, EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, and Quad Product manufactured, used or sold by Licensee shall consist of dose concentrations of TAF, EVG and/or COBI that have been approved by the FDA.

  • All EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, and Quad manufactured, used or sold by Licensee shall consist of single dose concentrations of EVG and/or COBI that are the same as the dose concentration for such agent that has been approved by the FDA.

  • Such Licensed Know-How shall be sufficient to enable Licensee to manufacture TDF and TDF Product, EVG and COBI, EVG Product, COBI Product and Quad, at commercial-scale quantities.

  • Promptly following the Effective Date, Gilead shall make a one-time technology transfer of know-how owned or controlled by Gilead as of the Effective Date relating to the manufacture of TDF, TDF Product and TDF Quad, COBI, COBI Product, EVG and EVG Product to the extent and in the manner specified in Appendix 3 hereto.

  • All TAF Product, TAF Combination Product, EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, BIC Product, BIC Combination Product, and TAF Quad manufactured, used or sold by Licensee shall consist of single dose concentrations of TAF, EVG, COBI, and/or BIC, that are the same as the dose concentration for such agent that has been approved by the FDA.

  • In the event of termination of this Agreement by AVEO under Section 9.3 or 9.4 or termination by COBI under Section 9.2, COBI will be deemed to have granted to AVEO a royalty-free, worldwide, perpetual exclusive, sublicensable, license under any COBI Product Patent Rights and COBI Product Know-how to the extent necessary or reasonably useful to develop, manufacture, market, sell or use Licensed Product in the Field in the Territory and solely for such purpose.

  • Once the Semi-Exclusive Term expires, or if Gilead terminates Licensee’s rights in the Semi-Exclusive Territory due to Licensee’s non-compliance with this Agreement, then the semi-exclusive license granted in Section 2.2(b) shall terminate, and Gilead in its sole discretion may authorize other Licensed Product Suppliers to register and sell COBI Product, COBI Combination Product, EVG Product, EVG Combination Product, and/or Quad in such territory.

  • Licensee acknowledges that as of the Amended and Restated Effective Date Gilead has made the one-time technology transfers available to Licensee, whether directly or through MPP, of know-how owned or controlled by Gilead relating to the manufacture of TAF, EVG, COBI, TAF Product, EVG Product, COBI Product, and TAF Quad, in each case as described in Appendix 3 hereto.

  • Licensee agrees that it will not sell, offer for sale, or assist third parties in selling Product except for the sale and offer for sale of (A) TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG Product, EVG Combination Product and Quad for use in the Field and in the countries of the EVG-Quad Territory.

Related to COBI Product

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

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

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

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • 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.”