Common use of Rights of Reference; Further Assurances Clause in Contracts

Rights of Reference; Further Assurances. NVS hereby grants to HMI a “Right of Reference,” 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 the data included in any Regulatory Submissions for an In-Vivo [***] Product or a [***] Product in the Ex-Vivo Field that incorporates the same Candidate as the In-Vivo [***] Product to the extent necessary for HMI’s Commercialization of such In-Vivo [***] Product in the U.S. HMI hereby grants to NVS a “Right of Reference,” 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 included in any Regulatory Submission for an In-Vivo [***] Product in the U.S. to the extent necessary for NVS’ Development, Manufacturing, or Commercialization of In-Vivo [***] Products outside of the U.S. or [***] Products in the Ex-Vivo Field incorporating the same Candidate as the In-Vivo [***] Product. The Party granting the right of reference under this Section 7.4 (Rights of Reference; Further Assurances) will execute and deliver, or will cause to be executed and delivered, to the non-granting Party such endorsements, assignments, and other documents as may be reasonably necessary to effect the foregoing right to reference. Such actions may include providing a signed statement that the non-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 information 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 [***] Products, in each case, to the extent provided under this Section 7.4 (Rights of Reference; 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.

Rights of Reference; Further Assurances. NVS hereby grants to HMI a “Right of Reference,” 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 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 Candidate as the In-Vivo [***] SCD Product to the extent necessary for HMI’s Commercialization of such In-Vivo [***] SCD Product in the U.S. HMI hereby grants to NVS a “Right of Reference,” 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 included 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 of the U.S. or [***] Sickle Cell Products in the Ex-Vivo Field incorporating the same Candidate as the In-Vivo [***] SCD Product. The Party granting the right of reference under this Section 7.4 (Rights of Reference; Further Assurances) will execute and deliver, or will cause to be executed and delivered, to the non-granting Party such endorsements, assignments, and other documents as may be reasonably necessary to effect the foregoing right to reference. Such actions may include providing a signed statement that the non-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 information 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 Reference; 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.