TAF Quad definition

TAF Quad means the finished pharmaceutical product containing TAF, emtricitabine, EVG and COBI (each at their dose concentration approved by the FDA or applicable regulatory authority) as its only active pharmaceutical ingredients, and that is manufactured and sold as a fixed-dose single-tablet regimen and not as a bundled or co-packaged product.

TAF Quad or “ the TAF Quad ” shall mean the finished pharmaceutical product containing TAF (at the dose concentration approved by the FDA or applicable regulatory authority), emtricitabine (200 mg), EVG and COBI (each at their dose concentration approved by the FDA or applicable regulatory authority) as its only active pharmaceutical ingredients, and that is manufactured and sold as a fixed-dose single-tablet regimen and not as a bundled or co-packaged product.

Examples of TAF Quad in a sentence

• Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or TAF Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the right, but not the obligation, to bring an infringement or other action at its own expense, in its own name, and entirely under its own direction and control.

• Promptly following the later of the Effective Date and Gilead’s receipt of marketing approval from the FDA for the TAF Quad, Gilead shall make available a one-time technology transfer of know-how owned or controlled by Gilead relating to the manufacture of TAF Quad, to the extent, and in the manner specified in Appendix 3 hereto Except as expressly provided in this Section 5.4, Gilead shall have no further obligation to transfer any other know-how under this Agreement.

• Within sixty (60) days after the end of each calendar quarter, Licensee shall provide Gilead with a detailed report (the “Quarterly Report”) that includes at least the information set forth in this Section 4.3. If any Quarterly Reports relate to EVG, EVG Product, EVG Combination Product or TAF Quad, Gilead will have the right to share such Quarterly Reports with Japan Tobacco.

• 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.

• The licenses relating to EVG, EVG Product, EVG Combination Product and TAF Quad granted to Licensee under this Agreement include sublicenses of intellectual property rights from Japan Tobacco, and remain subject to the terms and conditions of the Japan Tobacco Agreement.

• To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or TAF Quad, Gilead shall also have the right to share such agreements with Japan Tobacco.

• Licensee shall require any Third Party Reseller to agree, in a written agreement with Licensee, (i) to comply with the applicable terms of this Agreement and (ii) to report to Licensee such information, and allow Licensee to provide Gilead with the information described in Section 4.3 (and also to provide Japan Tobacco with such information to the extent it relates to EVG, EVG Product, EVG Combination Product, or TAF Quad).

• Gilead will bear the full cost of any such audit, and shall have the right to share the outcome of any such audit with Japan Tobacco to the extent such outcome relates to EVG, EVG Product, EVG Combination Product, or TAF Quad.

• To the extent any such audit relates to EVG, EVG Product, EVG Combination Product, or TAF Quad, Gilead will have the right to share reports from any such audit with Japan Tobacco.

• 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.