Clinical Trial Data. Right of Reference Sample Clauses

Clinical Trial Data. Right of Reference. 5.4.1.1. From and after the Effective Date, with respect to Franchise Product 1 and Franchise Product 2, and from and after the Option Exercise Date, with respect to Franchise Product 3, (i) Novartis shall maintain a database containing all clinical trial data accumulated from all clinical trials of the applicable Licensed Product conducted by, on behalf of, or with the support of Novartis in the Territory or outside the Territory if Amgen agrees ([*]), and (ii) Amgen shall maintain a database containing all clinical trial data accumulated from all clinical trials of the applicable Licensed Product conducted by, on behalf of, or with the support of Amgen outside the Territory or in the Territory ([*]). Each Party shall require that, with respect to any clinical trial conducted pursuant to the Development Plan, study investigators obtain patient authorizations and consents required under the United States Health Insurance Portability and Accountability Act of 1996, the EU Data Protection Directive or any other similar applicable Law in connection with such clinical trial to permit the sharing of clinical data from such clinical trial with the other Party. 5.4.1.2. From and after the Effective Date, with respect to Franchise Product 1 and Franchise Product 2, and from and after Option Exercise Date, with respect to Franchise Product 3, upon the request of either Party, the other Party shall provide a right of reference to any requested Regulatory Filings or Regulatory Approvals for each Licensed Product (provided that Novartis shall not grant a right of reference to Novartis [*] Data and any Regulatory Filings or Regulatory Approvals referring to Novartis [*] Data, and Amgen shall not grant a right of reference to Amgen [*] Data and any Regulatory Filings or Amgen Ref. No. 2015641252 Page 31 Regulatory Approvals referring to Amgen [*] Data), in each case as [*] for the requesting Party’s Development, Manufacture (in the case of Amgen only), conduct of Medical Affairs Activities with respect to, or Commercialization of the applicable Licensed Product as permitted hereunder. Each Party shall be entitled to sublicense such right to any permitted licensee pursuant to Section 4.3 (Sublicensing).
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