Examples of Nonconforming API in a sentence
The expenses incurred by the Parties for the testing and evaluation by the Third Party shall be borne by Equateq unless Amarin has claimed that the API is subject to (or is suspected of being subject to) a Nonconformity and the API in question is ultimately found not to be Nonconforming API, in which case the said expenses shall be borne by Amarin.
In connection with the destruction of API or Product incorporating the Nonconforming API, Equateq shall be solely responsible for [***].
In the event that (i) any quantity of API is found to be Nonconforming API or (ii) any recall, withdrawal, field correction, field alert report or comparable report or Third Party return of any Product is initiated because of Nonconforming API or due to any negligence, recklessness or wrongful intentional acts or omissions by, or strict liability of, or breach of representation or warranty by, Equateq, then Amarin may, at Amarin’s discretion: [***].
When storing and handling API, Third Party Materials, Nonconforming API, or API-derived wastes, Equateq shall comply with, and shall maintain all storage facilities in compliance with, the API Specifications, cGMPs, and Legal Requirements.
Any dispute between the Parties concerning whether rejected API is in fact Nonconforming API that the Parties are unable to resolve within a sixty (60) day period from Buyer’s rejection notice will be investigated in accordance with the Quality Agreement.
In the event of a Product recall, field alert, withdrawal or field correction (“ Recall ”) that does not result from Nonconforming API, then, as between Noramco and Buyer, Buyer shall (i) be responsible for the expenses of the recall and (ii) reimburse Noramco for any costs reasonably expended by Noramco to assist Buyer to investigate and/or effect the Recall.
Buyer shall, at Noramco’s election and expense, either return the Nonconforming API to Noramco or destroy the Nonconforming API and have an authorized officer of Buyer certify such destruction in writing.
If Noramco agrees, or there is a determination under Section 8.3, that any API is Nonconforming API, then Noramco, at its sole cost (including shipping), and as Buyer’s sole remedy, shall promptly replace the Nonconforming API.
Upon receipt of a timely-delivered rejection notice and sample pursuant to Section 8.1, Noramco will have thirty (30) calendar days to inspect the alleged Nonconforming API and make a reasonable assessment of the alleged nonconformance.
All API may be inspected by Buyer and rejected if the API does not meet the warranty set forth in Section 11.1(iii) (any such API, “ Nonconforming API ”).