Examples of Nonconforming API in a sentence
Upon confirmation of a Nonconformity, the Parties shall meet to discuss the situation and mutually agree in good faith that there is a compelling need to replace all or a portion of such Nonconforming API after taking into account all relevant facts and circumstances, including the remaining period in the Term, the status of API manufacturing transfer activities, the nature of the Nonconformity and ability to rework, current Product inventories, Product sales and anticipated changes in Product demand.
To the extent the Parties agree such Nonconforming API will be replaced, then any replacement schedule shall take into account GSK's manufacturing schedules, availability of materials to produce API, Product sales levels, Product inventories, and similar relevant considerations.
The determination as to whether all or part of such API is Nonconforming API by such laboratory or expert, as the case may be, will be final and binding on the Parties absent manifest error.
The fees and expenses of the laboratory or expert, as the case may be, incurred in making such determination will be paid by Noramco if the API is determined to be Nonconforming API, and by Buyer in all other cases.
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: [***].
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.
At Noramco’s request, Purchaser must promptly supply samples of the allegedly Nonconforming API or some other evidence of nonconformity that Noramco may reasonably specify.
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 [***].
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.