definiens: as that term is defined in 21 C.F.R. § 314.3(b ) and any ana logous law, rule, or regulation outside of the U.S., to the data included in any Regulatory Submissions for an In- Vivo SCD Product or a Sickle Cell Product in the Ex - Vivo Field that incorporates the same Candid ate as the In - Vivo SCD Product to the extent necessary for HMI ’s Commercialization of such In - Vi vo SCD Product in the U.S. HMI hereby grants to NVS a as that term is defined in 21 C.F.R. § 314 . 3(b ) and any analogous law, rule, or regulation outside of the U.S., to any data incl uded in any Regulatory Submission for an In- Vivo SCD Product in the U.S. to the extent necessary for NVS ’ Development, Manufacturing, or Commercialization of In - Vivo SCD Products outside o f the U.S. or Sickle Cell Products in the Ex - Vivo Field incorporating the same Candidate as the In - Vi vo SCD Product . The Party granting the right of reference under this Section 7.4 ( Rights of Referen ce ; Further Assurances ) will execute and deliver, o r will cause to be executed and delivered, to the non -granting Party such endorsements, assignments, and other documents as may be reasonably necessary to e ffect the foregoing right to reference . Such action s may include providing a signed statement that the n on - granting Party may rely on, and that the Regulatory Authority may access, in support of the non - granting Party ’s application for Regulatory Approval or providing any underlying raw data or in formation submitted by the granting Party to the Regulatory Authority with respect to any Regulatory Submissions or Regulatory Approval Controlled by the granting Party or its Affiliates that relate to In - Vivo SCD Products, in each case, to the extent provided under this Section 7.4 ( Rights of Referenc e ; Further Assurances ) ; provided, further, that in all cases, such right shall expressly exclude any data in Regulatory Submissions or Regulatory Approvals relating to any Other Components