Experimental Batch definition

Experimental Batch shall include without limitation any Batch manufactured following (i) a change in Specifications, (ii) implementation of the Improved Process, or (iii) a scale-up in the manufacturing process to produce greater quantities of Product, until SP has manufactured three (3) consecutive batches of Product meeting the new Specifications. ISTA shall be responsible to pay for each Experimental Batch which fails to meet the Specifications at the price agreed to by the parties (which price shall exclude the costs of Raw Materials and API provided by ISTA); provided that if such batch does not meet the Specifications due to SP's negligence, the failure of SP's Processing equipment, or SP's failure to adhere to the batch records, ISTA shall not be responsible for any such costs. SP and ISTA shall cooperate in good faith to resolve any problems causing the out-of-Specification Batch.
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Examples of Experimental Batch in a sentence

  • ISTA shall be responsible to pay for each Experimental Batch which fails to meet the Specifications at the price agreed to by the parties (which price shall exclude the costs of Raw Materials and API provided by ISTA); provided that if such batch does not meet the Specifications due to SP's negligence, the failure of SP's Processing equipment, or SP's failure to adhere to the batch records, ISTA shall not be responsible for any such costs.

  • The term "Experimental Batch" shall include without limitation any Batch manufactured following (i) a change in Specifications, (ii) implementation of the Improved Process, or (iii) a scale-up in the manufacturing process to produce greater quantities of Product, until SP has manufactured three (3) consecutive batches of Product meeting the new Specifications.

  • Each Batch of Product manufactured under this Agreement will be considered to be an "Experimental Batch" until SP has manufactured three (3) consecutive Batches of Product which meet the Specifications applicable to such Product.

  • Should ISTA reject any Non-Conforming Batch pursuant to Section 9.B, or if SP refuses to release a Batch which is not an Experimental Batch, SP will promptly credit ISTA's account for any portion of SP's fee for such Batch (plus shipping, insurance and customs charges not included therein) already paid by ISTA pursuant to this Agreement and subject to the limitations in Section 13, for the cost of ISTA-provided API used in such Batch.

Related to Experimental Batch

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.