Common use of Regulatory Status Updates Clause in Contracts

Regulatory Status Updates. Novartis shall be responsible for preparation of the registration dossier (including without limitation the expert reports, as well as any foreign language translations of the dossier) to be used for Approval Applications in the Territory. On a semi-annual basis following the date of exercise of the Option, Novartis shall prepare a Regulatory Status Update which shall set forth the status of all Approval Applications to be submitted to Regulatory Authorities in connection with the Commercialization of the Product, including time lines for such submissions. Each such Regulatory Status Update shall be treated by the Parties as Confidential Information in accordance with Article 13.1(a).

Regulatory Status Updates. Novartis shall be responsible for preparation of the registration dossier (including without limitation the expert reports, as well as any foreign language translations of the dossier) to be used for Approval Applications in the Territory. On a semi-annual basis following the date of exercise of the OptionEffective Date, Novartis shall prepare a Regulatory Status Update which shall set forth the status of all Approval Applications to be submitted to Regulatory Authorities in connection with the Commercialization of the Product, including time lines for such submissions. Each such Regulatory Status Update shall be treated by the Parties as Confidential Information in accordance with Article 13.1(a).