Rights of Reference. Each Party shall have the right to cross reference, file or incorporate by reference any regulatory filing or drug master file (as defined in 21 C.F.R. 314.420, or as amended from time to time, or the corresponding foreign equivalent) (and any data contained therein) for any Collaboration Product, or any component thereof, made in any country in the Territory (including all Regulatory Approvals) in order to support regulatory filings that such Party is permitted to make under this Agreement for any Collaboration Product or Royalty Product and to enable either Party to fulfill its obligations under this Agreement to Develop, Manufacture or Commercialize in the Territory any such Collaboration Product or Royalty Product. Each Party shall support the other, as may be reasonably necessary, in obtaining Regulatory Approvals for each Collaboration Product and Royalty Product, including providing necessary documents, or other materials required by applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement.
Appears in 4 contracts
Samples: Collaboration and License Agreement (Facet Biotech Corp), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)
