Nonconforming API definition
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.
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.
Such audits may be conducted [***] each [***]; provided, however, that Amarin may conduct additional “for cause” audits during a [***] to the extent Chemport supplies Nonconforming API or in the event of Product complaints or Adverse Events caused by Nonconforming API.
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.
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.
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.