Examples of HCV Product in a sentence
If Idenix or its Affiliates manufacture the relevant IDX HCV Product, Idenix will permit, and cooperate with, inspections by applicable health authorities.
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 Agreement shall be deemed to grant Idenix the right to research, Develop, Manufacture or Commercialize any Novartis HCV Product or to incorporate any Novartis compound into any pharmaceutical product.
Notwithstanding anything to the contrary contained herein, (a) Novartis, if it does not exercise the Novartis HCV Option, or an ODC Option for an Other HCV Product, shall not be liable for any failure to use such Commercially Reasonable Efforts within the aforementioned twenty-four (24) month period, and (b) Novartis shall in no event have any obligation to use such Commercially Reasonable Efforts after the expiration of such twenty-four (24) month period.
Failure Investigations Idenix will investigate any non-conforming IDX HCV Product or other deviation relating to the manufacture of the IDX HCV Product.
In no event may Novartis use an Idenix HCV Product, nor conduct an HCV Combination Clinical Trial, to have lifted, or attempt to have lifted, a Clinical Hold from a Novartis HCV Product or Novartis HCV Compound or to change a full Clinical Hold to a partial Clinical Hold for a Novartis HCV Product or Novartis HCV Compound.
Without limiting the generality of the foregoing, Idenix shall be solely responsible for all royalties, fees or other amounts payable pursuant to the agreements set forth in Exhibit J with respect to the HBV Drug Candidates, HBV Products, Initial HCV Drug Candidate and the HCV Product (solely if it contains the Initial HCV Drug Candidate).
Supply Security Continuous supply and non-supply Idenix will supply IDX HCV Product to Novartis for the relevant HCV Combination Trial pursuant to Novartis’ firm orders.
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.
Validation Idenix undertakes to qualify and validate the equipment and manufacturing process and the manufacturing facility for the applicable IDX HCV Product to the extent required for the applicable stage of the HCV Combination Clinical Trial.