Development Batches. Each Batch produced under this Agreement, including those necessary to support the validation portion of Client’s submissions for Regulatory Approvals, will be considered to be a “development batch” unless and until Processing has been validated. Client shall be responsible for the cost of each such Batch, even if such Batch fails to meet the Specifications, unless Catalent was grossly negligent or acted intentionally in the Processing of the out-of-Specification Batch. Catalent and Client shall cooperate in good faith to resolve any problems causing the out-of-Specification Batch.
Development Batches. Each batch of Supplies produced under this Agreement will be considered to be a “Development Batch” until manufacturing, testing and storage methods and processes have been validated or qualified in accordance with industry standards (including production of at least [* * *] consecutive batches of Supplies that meet the applicable specifications). The term “Development Batch” shall include any batch manufactured following (A) a Change Order, or (B) a scale-up in the manufacturing process to produce greater quantities of Supplies, until Catalent has manufactured at least [* * *] consecutive batches of Supplies meeting the new specifications. Client shall be responsible for the cost of each Development Batch, even if such batch fails to meet the specifications therefor, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch. Catalent and Client shall cooperate in good faith to resolve any problems causing the out-of-specification batch.
Development Batches. Development Batches produced after the Effective Date shall be deemed to have been produced under the Development Agreement. Client will be responsible for the cost of such Development Batches, including those necessary to support the validation portion of Client’s submissions for Regulatory Approvals, which fail to meet the Specifications as set forth in Section 4.1 of the Development Agreement. Catalent and Client shall cooperate in good faith to resolve any problems causing the out-of-Specification Batch.
Development Batches. Each Batch produced under this Agreement pursuant to a Purchase Order or Palatin’s written request, including those necessary to support the validation portion of Palatin’s submissions for Regulatory Approvals, will be considered to be a “development batch” unless and until Processing has been validated. Palatin shall be responsible for the cost of each such development Batch, even if such development Batch fails to meet the Specifications, unless the cause of nonconformity is attributable to Catalent’s gross negligence or willful misconduct. Catalent and Palatin shall cooperate in good faith to resolve any problems causing the out-of-Specification Batch.
Development Batches. Each Batch produced under this Agreement, including those Processed as part of the Validation Services and necessary to support the validation portion of Client’s submissions for Regulatory Approvals, will be considered to be a “development batch” unless and until Processing has been validated (as defined by the FDA) and in accordance with the Validation Services. Client shall be responsible for the cost of each such Batch, even if such Batch fails to meet the Specifications, unless such Batch of Product was not Processed in accordance with the mutually agreed batch records for such Batch or Catalent was grossly negligent in the Processing of the out-of-Specification Batch.
Development Batches. Each Batch produced under this Agreement, [****], will be considered to be a "development batch" unless and until Processing has been validated. [****] Catalent and Iroko shall [****] Information has been excluded from the exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed cooperate in good faith to resolve any problems causing the out-of-Specification Batch.
Development Batches. Each batch produced under this Agreement, including those (i) necessary to support the validation portion of Supernus’ submissions for Regulatory Approvals and (ii) Manufactured following a permitted change in Specification or equipment, will be considered to be a “development batch” unless and until Manufacturing has been validated. Supernus shall be responsible for the cost of each such batch, even if such Batch fails to meet the Specifications, unless Supplier was grossly negligent in the Manufacture of the out-of-Specification batch. Supplier and Supernus shall cooperate in good faith to resolve any problems causing the out-of-Specification batch.
Development Batches. Each batch produced under this Quotation, including those necessary to support the validation portion of Client’s submissions for regulatory approvals, will be considered to be a “development batch” unless and until processing has been validated. Client shall be responsible for the cost of each such batch, even if such batch fails to meet the specifications, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch. Catalent _______________________ **This portion has been redacted pursuant to a confidential treatment request. Catalent Pharma Solutions, LLC and Supernus Pharmaceuticals, Inc. Terms and Conditions and Client shall cooperate in good faith to resolve any problems causing the out-of-specification batch.
Development Batches. Each Batch produced under this Agreement including those necessary to support the validation portion of Client’s submissions for Regulatory Approvals, will be considered to be a “Development Batch” until manufacturing, testing, storage methods and processes have been validated in accordance with industry standards (including, with respect to initial Process validation at the Facility, production of at least 3 consecutive Batches of Product that meet the applicable Specifications). Additionally, the term Development Batch shall include any Batch manufactured following (i) a change in Specifications, or (ii) a scale-up in the manufacturing process to produce greater quantities of Product, until Catalent has manufactured the required number of consecutive Batches of Product meeting the new Specifications. All Development Batches shall be Processed pursuant to Quotations and QARs under the Development Agreement, provided that once released by Catalent following Processing of the minimum number of consecutive Batches that meet the applicable Specifications in accordance with the Quality Agreement, the resulting Product will become subject to the terms and conditions of this Agreement. Client acknowledges and agrees that Catalent does not warrant that any Development Batch will meet the Specifications or achieve any other desired technical outcomes. Catalent and Client shall cooperate in good faith to resolve any problem causing an out-of-Specification Batch.
Development Batches. Each batch of Supplies produced under this Agreement will be considered to be a “Development Batch” until manufacturing, testing and storage methods and processes have been validated or qualified in accordance with industry standards (including production of at least [* * *] consecutive batches of Supplies that meet the CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(B)(4) and 230.406 applicable specifications). The term “Development Batch” shall include any batch manufactured following (A) a Change Order, or (B) a scale-up in the manufacturing process to produce greater quantities of Supplies, until Catalent has manufactured at least [* * *] consecutive batches of Supplies meeting the new specifications. Client shall be responsible for the cost of each Development Batch, even if such batch fails to meet the specifications therefor, unless Catalent was grossly negligent in the manufacture of the out-of-specification batch. Catalent and Client shall cooperate in good faith to resolve any problems causing the out-of-specification batch.
