Common use of Manufacturer’s Documentation for Regulatory Purposes Clause in Contracts

Manufacturer’s Documentation for Regulatory Purposes. (“DMF”). Notwithstanding anything contained in this Agreement to the contrary, Orion shall at its expense have secured as of the Date of Agreement and shall maintain for so long as USL has the right to sell Product in the Territory under this Agreement, an authorization permitting USL to cross-refer to the DMF related to Compound used by Orion for manufacture of Product for reference by the Product NDAs. Such DMF shall contain all information related to the manufacture of Compound and the manufacturing facility used to produce Compound that is reasonably necessary to facilitate obtaining Regulatory Approvals for the Product in the Territory. Such authorization shall include the right of reference to such DMFs by all of the INDs and Product NDAs submitted under this Section 8.