Section 5.8. Data Exchange and Use Clause Samples
Section 5.8. Data Exchange and Use. The following language is hereby added at the end of Section 5.8 of the Agreement: “Without limiting the foregoing, with respect to the Clinical Data from the Tisle Combination Studies, (a) Zymeworks, its Affiliates and licensees will have the right to use such Clinical Data in accordance with this Agreement and for purposes of Developing and seeking Regulatory Approval of Licensed Products for use in combination with Tisle Products outside the Territory; and (b) BeiGene, its Affiliates and licensees will have the right to use such Clinical Data for purposes of (i) Developing and Commercializing Licensed Product in the Territory in accordance with this Agreement, and (ii) seeking Regulatory Approvals of Tisle Products for use in combination with Licensed Products worldwide.”
Section 5.8. Data Exchange and Use. The first sentence of Section 5.8 of the Agreement is hereby deleted in its entirety and replaced with the following: “In addition to its adverse event and safety data reporting obligations pursuant to Section 6.4, each Party shall promptly (but in any event no later than […***…] from the other Party’s request) provide the other Party with copies of all data and results, including all Clinical Data, and all supporting documentation (e.g. protocols, CRFs, analysis plans) Controlled by such Party or its Affiliates that are generated by or on behalf of such Party or its Affiliates or sublicensees, if applicable, in the Development of Licensed Products, including, with respect to Zymeworks, in the conduct of the Zymeworks Territory Studies; provided that Zymeworks shall only be required to provide BeiGene such data, results and documentation to the extent it comprises Zymeworks Know-How and is reasonably necessary or useful for BeiGene’s Development or Commercialization of the Licensed Products in the Field in the Territory, including any such data, results and documentation that are reasonably requested by BeiGene or that are necessary to support filings for Regulatory Approval for the Licensed Product in the Territory. 8”