Marketing Approval

Marketing Approval. Means: (a) in the case of a Designated Assay, receipt from the FDA of such authorization, approval or clearance as is legally required to market and sell such Designated Assay for clinical use in the Field in the Territory as a companion diagnostic for a Tocagen Product, any such authorization, approval or clearance that is limited to performance of such Designated Assay at the Laboratory being referred to herein as "LDT Marketing Approval" and any such approval, authorization or clearance that... authorizes the sale to Third Parties of the means to perform such Designated Assay being referred to herein as "IVD Marketing Approval"; and (b) in the case of a Tocagen Product, FDA approval of a BLA/NDA for a Tocagen Product. View More

Marketing Approval. Means the receipt of the applicable approvals, licenses, registrations or authorizations of any federal, state or local Regulatory Agency, department, bureau or other governmental entity, necessary for the sale of a Product in a country or region, but shall not include Price Approval in any country.