Changes to Licensed Clause Samples

Changes to Licensed. Process The process by which changes are made to the Licensed Process used for the manufacture of the Bulk Drug Substance shall be governed by the Quality Agreement. Any such changes proposed by Solvay or required by Regulatory Authorities to the Licensed Process shall be done at Solvay’s expense. Solvay shall provide Cadence with all information needed to review and approve any changes that are necessary to amend the NDA for any Drug Product or foreign equivalent as a result of any approved Licensed Process change. Solvay shall continue to supply Cadence with Bulk Drug Substance approved under Cadence’s existing NDA and other regulatory submissions of Cadence (or any Affiliate or Sublicensee of Cadence) until such time as Drug Product manufactured under the changed process is approved by each applicable Regulatory Authority, except as the Parties otherwise agree by separate written agreement. Notwithstanding the foregoing, in the event any changes to the Licensed Process are requested by Cadence, Solvay shall review the requested changes and Cadence shall obtain Solvay’s written approval, prior to the implementation of any such changes. Solvay shall use reasonable efforts to accommodate any such change requested by Cadence. Changes to the Licensed Process requested by Cadence shall be done at Cadence’s expense. All costs associated with any other changes to the Licensed Process shall be mutually determined by the Parties.