Product Specifications definition
Examples of Product Specifications in a sentence
In case Hanmi desires to implement any such changes to Production and/or Product Specifications (including [***]), Hanmi shall inform Spectrum in writing of such changes and provide all relevant data and rationale for the proposed changes.
If Spectrum is required to recall any Product because such Product may violate local, state or federal laws or regulations, the laws or regulations of any applicable foreign government or agency, or the Product Specifications, or in the event that Spectrum wishes to institute a voluntary recall, then Spectrum shall first discuss such recall with ▇▇▇▇▇ and will be responsible for coordinating such recall.
If during the Production of any Batch of a Product, any reprocessing or reproduction is permitted and required in order to meet the Product Specifications, Hanmi will conduct such reprocessing in compliance with cGMP and the BLA.
Written approval from Spectrum shall be required for changes to Production and/or Product Specifications prior to the Production of Products.
Hanmi will be responsible for all costs and expenses incurred in connection with any reprocessing or reproduction, unless it is due to a change to the Product Specifications requested or ordered by Spectrum or FDA or any other Regulatory Authority in the Spectrum Territory in writing.