Development Batches Clause Samples

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, 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 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 necessary to support the validation portion of Client’s submissions for Regulatory Approvals, will be considered to be a “development batch” unless and until Manufacturing has been validated. Client shall be responsible for the cost of each such Batch, even if such Batch fails to meet the Specifications, unless CoreRx was grossly negligent or failed to comply with Applicable Laws in the Manufacturing of the out-of-Specification Batch. CoreRx and Client shall cooperate in good faith to resolve any problem causing the out-of-Specification Batch. For clarity, when a validation Batch is ultimately used for commercial purposes, such Batch shall no longer be considered a development 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” 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 and Client shall cooperate in good faith to resolve any problems causing the out-of-Specification Batch. [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Development Batches. Until validation has been completed, each Batch Processed under this Agreement, including those necessary to support the validation portion of Supernus’ submissions for Regulatory Approvals, will be considered to be a “development batch” unless and until Processing has been validated. Supernus shall be responsible for the cost of each such Batch, even if such Batch fails to meet the Specifications, unless Catalent was [**] in the Processing of the out-of-Specification Batch. Catalent and Supernus shall cooperate in good faith to resolve any problem causing 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. Until a Regulatory Approval of the Product for commercial sale, 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. Additionally, any Batch Processed after a (i) material change in Specifications, (for clarity, the materiality of a change will be determined by a risk assessment between the Parties)(in general, minor changes to Process or Product testing specifications shall not constitute a “material change”) or (ii) a change in scale of the Process to produce different quantities of Product (including, as applicable, after any Regulatory Approval) shall be considered a Development Batch until Catalent has Processed at least [***] consecutive batches of Product meeting the new Specifications (or existing Specifications at the changed scale, as applicable), and the Process has been revalidated and qualified by Catalent’s Quality and Validation departments. Client shall be responsible to pay the Price and all costs of each Development Batch, even if such Batch fails to meet the Specifications, unless Catalent was grossly negligent in the Processing of the out-of-Specification Batch. Catalent and Client shall cooperate in good faith to resolve any problem causing the out-of-Specification Batch. If Client requests that Catalent Process a replacement Batch for any Development Batch, then (a) Client shall be obligated to pay Catalent its Services for Processing such replacement Development Batch and (b) all Raw Materials, Client-dedicated Materials, and Client-supplied Materials for such replacement Development Batch shall be at Client’s cost and expense. Under no circumstances shall Catalent have any liability to Client for any Raw Materials or Client Materials consumed in a Development Batch. Client shall not sell or distribute any Development Batch for commercial use unless it has obtained required Regulatory Approvals for commercial use of such Batches and provided satisfactory proof of such Regulatory Approvals to Catalent. For the purpose of the clarity, as it relates to Client’s PRGN-2012 Product, [***] no additional Development Batch will be needed for Client’s PRGN-2012 Product, unless there a material change in Specifications or a change in scale of the Process to produce different quantities of Product as described above.