HCV Product definition
Examples of HCV Product in a sentence
Quality Systems Compliance The Parties will enter into a quality agreement (the “Quality Agreement”) appropriate for the supply of IDX HCV Product for the HCV Combination Clinical Trials, which will include without limitation the relevant requirements set forth in this Term Sheet.
Idenix will provide a Certificate of Analysis with each release in accordance with the specifications for the IDX HCV Product.
Other than documentation required to respond to requests from regulatory authorities or documentation needed by Novartis for release of IDX HCV Product in individual countries, Idenix will not be required to respond to documentation requests more than [**] times per year.
For the avoidance of doubt, nothing in this Section 4.1.2 shall restrict the right of Novartis and its Affiliates to Manufacture, Develop or Commercialize, or to grant licenses (with the further right to grant sublicenses) under any Know-How, Patent Rights or other intellectual property rights Controlled by Novartis to Manufacture, Develop or Commercialize, any Novartis HCV Product which is Co-Labeled with an Idenix HCV Product.
Annual price review With respect to IDX HCV Product manufactured by Idenix or its Affiliates, a review of COGs shall take place at least once per year and take into account changes in the manufacturing cost of the IDX Products as well as savings realized, which may include savings due to improved manufacturing procedures and higher yields, and other factors mutually-agreed between the Parties.
During any period while royalties are due under Section 6.2, Idenix shall provide to Novartis quarterly reports detailing sales of each Idenix HCV Product with respect to which royalties are due in accordance with Section 6.2, on a country-by-country basis, including all relevant Prescription and Co-Prescription data based upon which such royalties are calculated.
During any period while royalties are due under Section 6.2, Idenix shall provide to Novartis quarterly reports detailing its Net Sales (and adjustments thereto) with respect to each Idenix HCV Product with respect to which royalties are due in accordance with Section 6.2, on a country-by-country basis.
The format for such reports shall be mutually agreed by the Parties in good faith; provided, that such reports shall include, at a minimum, both Net Sales and gross sales on a country-by-country and Idenix HCV Product-by-Idenix HCV Product basis, in the applicable local currency(ies) for such sales and in United States Dollars and the calculation of royalties with respect thereto.
For clarification purposes, the foregoing provision shall not restrict any of Novartis' rights with respect to any interferon products within the Novartis Territory, or any Party's rights with respect to any interferon products that are not labeled for co-administration with the HCV Product or an Other HCV Product.
Shelf Life Upon delivery, the IDX HCV Products’ residual shelf life would be sufficient for the length of the relevant HCV Combination Clinical Trial, as described in the Development Plan, for which Novartis placed the firm order for such IDX HCV Product.