Remedies for Failed Batches and Defective Batches Sample Clauses

Remedies for Failed Batches and Defective Batches. The remedies set forth in Section 8.6 shall apply to all Failed Batches and Defective Batches.

Remedies for Failed Batches and Defective Batches. (a) If a Batch of Bulk Drug Substance or Drug Product Manufactured is a Failed Batch or a Defective Batch, at Passage Bio’s election, Catalent [*]. (b) Responsibility for the cost and expense of the Manufacture of a new Batch of Bulk Drug Substance and/or Drug Product or Reprocessing of the Failed or Defective Batch of Bulk Drug Substance and/or Drug Product shall be based upon the Primary Cause of the Batch failure or defect determined by the Batch Investigation (subject to Section 8.5): (i) if the Primary Cause is determined to be attributable to [*]; or (ii) if the Primary Cause is determined to be attributable [*]; or (iii) if the Primary Cause is unable to be determined or is determined to be [*]; or (iv) if the Primary Cause is determined to be attributable [*] (c) For each Failed or Defective Batch subject to Section 8.6(b)(i), (ii) and (iii), Passage Bio will [*]. For each Failed or Defective Batch subject to Section 8.6(b)(iv), Passage Bio shall be responsible for both [*]. (d) In the case of any Failed Batch or Defective Batch with respect to which Catalent is obligated to pay for the Passage Bio Materials pursuant to Section 8.6(b)(ii), Passage Bio shall provide the Passage Bio Materials to Catalent at a cost based upon [*].

Remedies for Failed Batches and Defective Batches. Catalent shall Reprocess or re-Manufacture all Failed Batches and Defective Batches regardless of the “root cause” that led to the termination or rejection of the Batch. The remedies set forth in Section 8.6 shall apply to all Failed Batches and Defective Batches.

Remedies for Failed Batches and Defective Batches. (a) If a clinical Batch of Bulk Drug Substance or Drug Product Manufactured prior to PPQ Completion is a Failed Batch or a Defective Batch, Catalent will at [**] election: (i) Manufacture a new Batch of Bulk Drug Substance and/or Drug Product that meets the Product Requirements and procure any necessary additional Raw Materials, at [**] cost and expense, as soon as practicable (including any substitute Batches of Bulk Drug Substance necessary to Manufacture a replacement Batch of Drug Product), taking into account the availability of Raw Materials, except that the Manufacture of the new Batch and any necessary additional Raw Materials shall be at [**] cost and expense if [**]; or (ii) if reasonably possible and acceptable to Sarepta for its purposes, Reprocess the Batch of Bulk Drug Substance or Drug Product and procure any necessary additional Raw Materials, at [**] cost and expense, as soon as practicable, with the goal that the Batch of Bulk Drug Substance and/or Drug Product meets the Product Requirements, except that the Reprocessing of the Batch and any necessary additional Raw Materials shall be at [**] cost and expense [**]. DOCPROPERTY DOCXDOCID DMS=InterwovenIManage Format=<<NUM>>_<<VER>> PRESERVELOCATION \* MERGEFORMAT 137289020_3 (b) Following PPQ Completion, if a Batch of Drug Product is a Failed Batch or a Defective Batch, Catalent will at [**] election: (i) at [**] cost and expense, including the cost and expense to Manufacture substitute Bulk Drug Substance but excluding the Additional Raw Materials Cost unless otherwise provided in Section 8.6(d), Manufacture a new Batch of Drug Product that meets the Product Requirements as soon as practicable, taking into account the availability of Raw Materials; or (ii) if reasonably possible and acceptable to Sarepta for its purposes, Reprocess the Batch of Drug Product, at [**] cost and expense, excluding the Additional Raw Materials Cost unless otherwise provided in Section 8.6(d), as soon as practicable, with the goal that the Batch of Drug Product meets the Product Requirements. (c) Following PPQ Completion, if an [**] Batch or a Batch of Bulk Drug Substance is a Failed Batch or a Defective Batch, Catalent will at [**] election: