Examples of Patheon Nonconformance in a sentence
In the event of any Product recall, withdrawal, or field correction resulting from a Patheon Nonconformance, Patheon shall bear […***…] associated with such recall, withdrawal, or field correction, which shall include […***…] of the recalled Product and all other […***…] incurred in connection with such recall, plus […***…] incurred by Flexion with respect to such Product.
Further, the foregoing examples each assume no Patheon Nonconformance.
Schedule 2.8(f) Expected Yield Rate Measuring Period Expected Yield Rate [**] [**] [**] [**] [**] [**] The Yield will be calculated by dividing (x) the total number of saleable batches Manufactured by Patheon including those non conforming batches not due to a Patheon Nonconformance but excluding Patheon Nonconformance batches by (y) (the total number of batches initiated by Patheon).
In addition, the following will be counted for the purpose of the Annual Volume: • Late Product; • any Non-Conforming Product based on or caused by a Patheon Nonconformance; • any Non-Conforming Product that is caused by any reason other than a Patheon Nonconformance for which a Product Fee is payable; and • any other Product including any development or engineering batches of Product for which a Product Fee is payable.
The minimum batch fee also applies when a Product Fee is payable in relation to Non-Conforming Product for reasons other than any Patheon Nonconformance, as described below, and subject to the terms of this Agreement and this Schedule.
For any Non-Conforming Product that is caused by any reason other than a Patheon Nonconformance, the Parties agree as follows (and this will supersede the terms of Section 2.8(d) of this Agreement): Type of fee/cost Whether payable by Flexion Product Fee No fee payable for a maximum of the greater of: (1) 10% of the total number of commercial batches that are produced in a calendar year (conforming and non-conforming); or (2) two batches per calendar year (non- conforming).
In all other circumstances that do not result from Patheon Nonconformance, all cost associated with any Product recall, withdrawal or filed correction will be borne by Client.
The minimum batch fee also applies when a Product Fee is payable in relation to Non- Conforming Product for reasons other than any Patheon Nonconformance, as described below, and subject to the terms of this Agreement and this Schedule.
For all batches of Non-Conforming Product that are caused by any reason other than a Patheon Nonconformance, Flexion will submit a Purchase Order for the replacement batch with a Scheduled Production Date on or before four months after the date that the Non-Conforming Product is rejected (if manufacturing capacity is available).
Notwithstanding anything in this ARTICLE IX to the contrary Patheon’s sole liability and Client’s sole and exclusive remedy whether in contract, tort, equity or otherwise for Non-Conforming Product based on or caused by a Patheon Nonconformance will be the rights and remedies set forth in Sections 2.2(o), 2.8, 2.9, 3.12, 3.14, 8.2 and 9.2 of this Agreement.