Examples of API Mixture in a sentence
This objective will be supported by the delivery to Zavante from Ercros and ERN of technical documentation, expertise and know-how for the API and API Mixture, and regarding Product manufacturing.
As used herein, the term, “Recall” includes any action (i) by Zavante to recover title to or possession of quantities of the API Mixture or the Product sold or shipped to Third Parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any Regulatory Authorities to detain or destroy any of the API Mixture and/or the Product.
Within [**] following the execution of this Agreement, the Parties shall in good faith negotiate and execute a Quality Agreement concerning the API Mixture (the “Quality Agreement”).
In the event that Ercros receives any complaint, claims or adverse reaction reports regarding API Mixture, including notices from the FDA regarding any alleged regulatory non-compliance of API Mixture, Ercros shall promptly and not more than [**] after receipt, provide to Zavante all information contained in the complaint, report or notice and such additional information regarding API Mixture as Zavante may reasonably request.
All of the reports data and information regarding sales of the Product and purchases of the API Mixture shall be Confidential Information of Zavante.
Within [**] after the end of each calendar year, Fisiopharma will prepare an annual reconciliation of API Mixture on the reconciliation report form including the calculation of the “Actual Annual Yield” or “AAY” for the Bulk Drug Vials during the calendar year.
The Purchase Order shall set forth the quantities of API Mixture desired, the desired delivery date and the desired destination for delivery.
Recall will also include any action by either Party to refrain from selling or shipping quantities of the API Mixture and/or the Product to Third Parties which would have been subject to a Recall if sold or shipped.
YOY growth Figure 1.2: EU fresh-cut fruit and vegetables market compared to other fruit and vegetables segments, 2005-2014f volume growth (f=forecast).
Ercros will be solely responsible for maintaining the DMF and all other regulatory filings and for conducting any other compliance efforts related to manufacturing the API Mixture that are required in order to obtain approval from the FDA of Zavante’s NDAs referencing the DMF and the API Mixture, at no additional cost to Zavante.