Process Development. i. Whether initiated by Keryx, BioVectra, or a joint effort of the two Parties, BioVectra may, at Keryx’s cost, from time to time and with the prior written agreement of Keryx, engage in Process Development Work. “Process Development Work” means the conduct by BioVectra of activities to develop, confirm and/or refine processes for producing the Product and/or activities to develop, optimize and/or scale-up a manufacturing process suitable for GMP Manufacture of the Product. A Party wanting to initiate Process Development Work will bring a proposed plan to the Supply Committee for consideration, approval, and further development. The Supply Committee will receive regular updates regarding the Process Development Work and generally oversee its progress. Any Improvements to the Manufacturing Procedure will be the sole and exclusive property of Keryx.
Appears in 2 contracts
Sources: Product Manufacture and Supply and Facility Construction Agreement (Akebia Therapeutics, Inc.), Product Manufacture and Supply and Facility Construction Agreement (Keryx Biopharmaceuticals Inc)