Common use of Access to Regulatory Filings Clause in Contracts

Access to Regulatory Filings. Acucela and Otsuka shall each have a right to cross reference or incorporate by reference any Regulatory Filings or drug master file (and any Data contained therein) for Collaboration Products made in any country in the Shared Territory (including all Regulatory Approvals) to support Regulatory Filings for Collaboration Products in each Party’s Sole Territory and to enable either Party to fulfill its obligations or exercise its rights granted or retained under this Agreement. In addition, in each agreement with an Affiliate or Third Party involving Data with respect to a Collaboration Product in the Field in the Shared Territory, the contracting Party shall require that such Affiliate or Third Party provide such Party with access to all such Data as is necessary or useful to be obtained for purposes of Regulatory Approvals.

Appears in 3 contracts

Sources: Co Development and Commercialization Agreement, Co Development and Commercialization Agreement (Acucela Inc.), Co Development and Commercialization Agreement (Acucela Inc)