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Japanese Pharmaceutical Affairs Law, including with respect to the content and filing of the Quality Agreement for Japan and accreditation as a manufacturer at the time of filing the <strong>JNDA</strong> for Product.", "The safety units from each of the Parties shall meet and agree upon written pharmacovigilance agreements for exchanging adverse event and other safety information relating to (i) the Development of Product within [**] ([**]) [**] of the Effective Date and (ii) the Commercialization of Product in connection with the first MAA (including a <strong>JNDA</strong> in the Territory or its equivalent outside of the Territory) for Product to be filed.", "The Parties agree that new data developed under this Agreement that is filed to the <strong>JNDA</strong> for Final Product may also be filed concurrently to the <strong>JNDA</strong> for Alternative Final Product.", "At any time, BMS and ImClone may agree to withdraw such Alternative Final Product <strong>JNDA</strong>.", 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