Product Failure means, in respect of a PRODUCT, (i) rejection by the FDA of the filing of the ANDA or 505(b)(2) application, (ii) failure to receive MARKETING AUTHORIZATION by the FDA following such application filing or (iii) the failure to complete the milestone in respect of such PRODUCT set forth in Schedule III within thirty (30) days of the date set forth on Schedule III (as the same may be extended by Agreement of the PARTIES).
Product Failure or “Defect” shall mean:
Product Failure has the meaning set forth in Section 4.1.2(b)(vi).
Examples of Product Failure in a sentence
Contractor shall maintain Technology Errors and Omissions insurance including Network Security, Privacy Liability and Product Failure coverage with limits of at least $1,000,000 per occurrence and $1,000,000 policy aggregate.
Coverage to include Errors or Omissions, Product Failure, Security Failure, Professional Liability and Personal Injury.
The policy shall include, but not be limited to Network Security, Privacy Liability and Product Failure.
Disputes related to whether or not a Technical Product Failure has occurred will be resolved in accordance with Section 14.8.
Upon termination of this Agreement pursuant to Section 13.3 for a Technical Product Failure, all licenses and rights to the FibroGen Technology granted to AstraZeneca under Article 7 shall terminate and, to the extent appropriate given the nature of the Technical Product Failure and subject to applicable law, including GCP, the other termination consequences set out in Sections 13.6(a) through 13.6(g) as well as Section 13.6(j) shall apply.
More Definitions of Product Failure
Product Failure means (a) as indicated in writing by Cempra to FFFC, no Drug Product will be marketed or further developed by or on behalf of Cempra, any Affiliate thereof, or any of its or their licensees in the Territory or (b) Drug Product is taken off the market or no longer able to be marketed in the Territory by or on behalf of Cempra, any Affiliate thereof, or any of its or their licensees in the Territory for the following reasons: (i) any non-approvable or rejection letter or withdrawal of a Marketing Approval application in the Territory or any order from Regulatory Authority withdrawing Drug Product from the market or otherwise suspending use of Drug Product in the Territory, (ii) any serious safety problem with respect to the Drug Product, or (iii) any infringement of Patents or infringement or misappropriation of other intellectual property right arising from the manufacture, development, use, or commercialization of Drug Product or manufacture of API hereunder, which the terminating Party in reasonably determines in good faith cannot be reasonably and promptly resolved after consultation with the other Party regarding whether the infringement or misappropriation could be cured or remedied via a license or other settlement without material adverse affect on either Party, provided, that in the case of the circumstances described in clauses (i) and (ii), the terminating Party must reasonably determine in good faith that the Drug Product cannot be approved, commercially sold for human therapeutic use, re-launched, or marketed in the Territory, as applicable, within six (6) months of the occurrence of the circumstances originally constituting such Product Failure.
Product Failure means a complete interruption of communications between any two (2) or more Locations.
Product Failure means a recognised component, design or technical defect in the Peripheral Product(s).
Product Failure means any error, unresolved problem, or defect in the Product(s) caused by or resulting from (1) an incorrect functioning of code or command files, or (2) an incorrect or incomplete statement or diagram in the Documentation, if such error, problem, or defect renders the code inoperable, causes the code to fail to meet the Specifications, causes Documentation to be inaccurate or incomplete in any material respect, causes incorrect results, or causes incorrect functions to occur in any material respect when any such materials are used for their intended purposes.
Product Failure means the failure of the Lead Product to meet the primary endpoints of any Phase III Clinical Trial necessary for NDA Approval as described in the Development Plan.
Product Failure means, with respect to a SHP625 Licensed Product for the PFIC Indication, ALGS Indication or Biliary Artesia Indication that both (A) after using Commercially Reasonable Efforts in accordance with Section 5.6 and as required under the Sanofi Agreement, Satiogen Agreement and Pfizer Agreement, as applicable, Mirum determines in good faith that further Development and Commercialization of Licensed Product is not commercially viable because of materially adverse pre-clinical or clinical pathology or toxicology data or clinical efficacy data with respect to such Licensed Product and (B) no SHP625 Licensed Product was previously successfully Commercialized for such Indication.
Product Failure means (a) as indicated in writing by Cempra to FFFC, no Drug Product will be marketed or further developed by or on behalf of Cempra, any Affiliate thereof, or any of its or their licensees in the Territory or (b) Drug Product is taken off the market or no longer able to be marketed in the Territory by or on behalf of Cempra, any Affiliate thereof, or any of its or their licensees in the Territory for the following reasons: (i) any non-approvable or rejection letter or withdrawal of a Marketing Approval application in the Territory or any order from Regulatory Authority withdrawing Drug Product from the market or otherwise suspending use of Drug Product in the Territory, (ii) any serious safety problem with respect to the Drug Product, or (iii) any infringement of Patents or infringement or misappropriation of other intellectual property right arising from the manufacture, development, use, or commercialization of Drug Product or manufacture of API hereunder, which the terminating Party in reasonably determines in good faith cannot be reasonably and promptly resolved after consultation with the other Party regarding whether the infringement or misappropriation could be cured or remedied via a license or other settlement without material adverse affect on either Party, provided, that in the case of the circumstances described in clauses (i) and (ii), the terminating Party must reasonably determine in good faith that the Drug Product cannot be approved, commercially sold for human therapeutic use, re- launched, or marketed in the Territory, as applicable, within six (6) months of the occurrence of the circumstances originally constituting such Product Failure.