Common use of Transfer of Data and Regulatory Materials Clause in Contracts

Transfer of Data and Regulatory Materials. The JDC shall determine the content and manner for sharing data and Regulatory Materials between the Parties. The lead Party for regulatory activities with respect to a particular Collaboration Product in a particular country (such Party, the “Lead Regulatory Party”), as provided in Section 4.3, shall provide the other Party with copies of the IND and of such other Regulatory Materials Controlled by the Lead Regulatory Party, in each case with respect to Collaboration Products. Specifically, within [ * ] after the Signing Date, Trubion shall provide Facet with a copy of all TRU-016 related Regulatory Materials in the form then existing, generated as of the Signing Date and Controlled by Trubion. The non-Lead Regulatory Party shall have the right, without any additional consideration, to use any and all such data and reports supplied by the Lead Regulatory Party under this Section 4.1 in connection with the Development and/or Commercialization of any Collaboration Products or Royalty Products in the Field, in the Territory in accordance with the terms of this Agreement, including the incorporation of such data or reports in any regulatory submissions.

Appears in 3 contracts

Samples: Collaboration and License Agreement (Facet Biotech Corp), Collaboration and License Agreement (Trubion Pharmaceuticals, Inc), Collaboration and License Agreement (Facet Biotech Corp)

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Transfer of Data and Regulatory Materials. The JDC shall determine the content and manner for sharing data and Regulatory Materials between the Parties. The lead Party for regulatory activities with respect to a particular Collaboration Product in a particular country (such Party, the “Lead Regulatory Party”), as provided in Section 4.3, shall provide the other Party with copies of the IND and of such other Regulatory Materials Controlled by the Lead Regulatory Party, in each case with respect to Collaboration Products. Specifically, within [ * [*] after the Signing Date, Trubion shall provide Facet with a copy of all TRU-016 related Regulatory Materials in the form then existing, generated as of the Signing Date and Controlled by Trubion. The non-Lead Regulatory Party shall have the right, without any additional consideration, to use any and all such data and reports supplied by the Lead Regulatory Party under this Section 4.1 in connection with the Development and/or Commercialization of any Collaboration Products or Royalty Products in the Field, in the Territory in accordance with the terms of this Agreement, including the incorporation of such data or reports in any regulatory submissions.

Appears in 1 contract

Samples: Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)

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