Regulatory Fees. All fees payable during the Term to the Regulatory Authority in the Territory, including without limitation any so called “annual user fee” or Regulatory Approval maintenance fees for the Product, as well as annual prescription drug product fees shall be borne and paid solely by [***]. Further, any fees payable to FDA or other Regulatory Authority in the Territory in connection with the filing or Regulatory Approval of Product shall be borne and paid solely by [***]. Any fees payable to FDA or other Regulatory Authorities related to any facilities used to manufacture the Product shall be the sole responsibility of [***]; provided, however, the foregoing shall not apply with respect to Product in the case where Orion elects not to, or is not entitled to, supply such Product pursuant to the provisions of Section 6.1.
Appears in 4 contracts
Samples: Quality Assurance Agreement (Osmotica Pharmaceuticals PLC), Quality Assurance Agreement (Osmotica Pharmaceuticals LTD), Quality Assurance Agreement (Osmotica Pharmaceuticals LTD)
