Compliance with cGMP. BioVectra shall use its best efforts to produce the Product under cGMP conditions. Provided however that BioVectra shall be obligated to ensure that the third Batch of Product is produced under cGMP conditions. BioVectra shall monitor and maintain reasonable records respecting its compliance with cGMP, including those referenced in the Quality Assurance Agreement, or as Helix may otherwise reasonably request from time to time. BioVectra further agrees to comply with any and all corrective actions mutually agreed to by the Parties pursuant to any audit performed pursuant to section 5.1. Actual and Reasonable Costs and Expenses incurred by BioVectra with regards to any mutually agreeable implemented corrective actions, except in the event and to the extent that such costs are directly attributable to BioVectra’s breach of the warranties set forth in Sections 11.1 and 11.2 shall be borne by Helix.
Appears in 3 contracts
Sources: CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp)