Common use of Reprocessing Clause in Contracts

Reprocessing. 7.5.1. GW hereby agrees that it will not use any material for NOVARTIS that does not meet specifications after testing. 7.5.2. Reprocessing of intermediate drug product and drug product by an appropriate and authorised procedure after evaluation of the risks involved is only allowed in exceptional cases and is in the registered method of manufacture, provided that material is suitable for such a process and the resulting Product meets its specifications with no significant changes in Product quality. 7.5.3. Where reprocessing is required, NOVARTIS will be informed prior to reprocessing, and the instructions to perform such reprocessing shall be documented into the appropriate master production records. 7.5.4. NOVARTIS does not permit any rework of products or product intermediates in the sense of performing process steps that are different from the agreed manufacturing process, such as using different solvents or changing the batch size outside of +/- 10% of registered size. 7.5.5. Repackaging activities (i.e. reprocessing of assembled or partially-assembled packs) are allowed only in exceptional cases and require prior written approval from NOVARTIS.