Filing and Maintenance of the Health Registrations. As between the Parties, Keryx shall have the sole right to prepare and file for the Health Registrations, including the CMC, with the applicable Authorities, and, for clarity, BioVectra shall have no right to do so and shall not communicate with any Authorities in connection with any Health Registration. If determined by Keryx (in its sole discretion), Keryx shall have the right to include a designation of BioVectra and the Facility as a manufacturer and manufacturing site of Product in the applicable Health Registrations.
Appears in 1 contract
Sources: Product Manufacture and Supply and Facility Construction Agreement (Keryx Biopharmaceuticals Inc)
Filing and Maintenance of the Health Registrations. As between the Parties, Keryx shall have the sole right to prepare and file for the Health Registrations, including the CMC, with the applicable Authorities, and, for clarity, BioVectra shall have no right to do so and shall not communicate with any Authorities in connection with any Health Registration. If determined by Keryx (in its sole discretion), Keryx shall have the right to include a designation of BioVectra and the API Facility as a manufacturer and manufacturing site of Product in the applicable Health Registrations.
Appears in 1 contract
Sources: Manufacture and Supply Agreement (Akebia Therapeutics, Inc.)