Common use of Galderma Product Data Clause in Contracts

Galderma Product Data. After [***], upon Sol-Gel’s reasonable request, Galderma shall make available to Sol-Gel copies of Galderma Regulatory Documents, clinical and preclinical data, and efficacy, safety and pharmacovigilance data, in each case, that pertain to the Licensed Product and are Controlled by a Galderma Entity or its sub-contractor (collectively, the “Galderma Product Data”), to the extent such Galderma Product Data are reasonably necessary for Sol-Gel or its Affiliates or (sub)licensees to exercise Sol-Gel’s retained rights. Galderma and its Affiliates hereby grant to Sol-Gel a Right of Reference to, and a right to copy, access, and otherwise use, all information and data included in any Regulatory Filing, Regulatory Approval, drug master file, or other regulatory documentation owned or Controlled by Galderma or its Affiliates that relates to the Licensed Product, and Galderma shall provide a signed statement to this effect, if requested by Sol-Gel, in accordance with 21 C.F.R. § 314.50(g)(3) (or any successor rule or analogous Law recognized outside of the United States).