DS Batch Failure Sample Clauses

DS Batch Failure. (i) During each calendar year, Biogen is expected to maintain the production success rates for commercial DS Batches as included in Schedule 6 attached hereto. If during such time less than 10 commercial batches are produced, then the time period will be extended until 10 or greater commercial batches have been produced. The costs of commercial batch failures will be borne by the parties based on the production success rates and as set forth on Schedule 6 attached hereto. (ii) The cost of clinical batch failures will be borne by the parties as set forth in Schedule 6 attached hereto. (iii) To the extent Bioverativ is responsible for any costs related to batch failures as set forth in Schedule 6, it will pay Biogen the cost incurred by Biogen, including the cost of raw materials. To the extent Biogen is responsible for any costs related to batch failures as set forth in Schedule 6, it will be responsible for its cost incurred, except for failures resulting from incoming raw materials which were properly inspected upon receipt or due to product process changes initiated at the request of Bioverativ. (iv) Any batch failures resulting from incoming raw material or process failures due to product process changes initiated at the request of Bioverativ will not be factored into the success rate calculations and will be paid for according to Schedule 6, including raw materials, by Bioverativ. In the case of gross negligence, Biogen will be financially responsible for any costs related to batch failures, including raw materials. (v) For batch failures, Bioverativ may elect to: (1) not request replacement of the failed batches, with no impact to the requirements of the Binding Forecast or Semi-Binding Forecast and without financial impact to Bioverativ; (2) cause Biogen to manufacture, at Biogen’s cost and expense, a new DS Batch that conforms to the Specifications as soon as practicable using commercially reasonable efforts, taking into account the availability of materials; or (3) cause Biogen to reprocess, at a cost and expense per pre-defined success rate criteria set forth on Schedule 6 attached hereto, the DS Batch (if reasonably possible), with the goal that the reprocessed DS Batch conforms to the Specifications as soon as practicable using commercially reasonable efforts. (vi) Notwithstanding any provision herein to the contrary: (i) Biogen will be responsible for any loss of resin or similar high value material resulting from gross negligence or willful mi...