CMOs. Dynavax represents and warrants to Purchaser that (i) each Facility at which CpG Material is manufactured, tested, stored, packaged, labeled or supplied, is operated Confidential in compliance with Applicable Laws, including GMP and is registered with the applicable Regulatory Authority; and (ii) its agreements with its CMOs, including any quality or pharmacovigilance agreements, contain terms that are customary in biopharmaceutical industry and required to ensure that the CpG Material is manufactured, tested, stored, packaged, labeled, and supplied in compliance with Applicable Laws, including GMP.
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CMOs. Dynavax represents and warrants to Purchaser that (i) each Facility at which CpG Material is manufactured, tested, stored, packaged, labeled or supplied, is operated Confidential in compliance with Applicable Laws, including GMP and is registered with the applicable Regulatory Authority; and (ii) its agreements with its CMOs, including any quality or pharmacovigilance agreements, contain terms that are customary in biopharmaceutical industry and required to ensure that the CpG Material is manufactured, tested, stored, packaged, labeled, and supplied in compliance with Applicable Laws, including GMP.
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Sources: Supply Agreement (Valneva SE)