Source of Supply. It is understood that after the Alternate Supplier is qualified, SutroVax shall have the right under this Supply Agreement and the Phase 3/Commercial Supply Agreement to specify whether Extract ordered from Sutro pursuant to this Agreement or the Phase 3/Commercial Supply Agreement will be Manufactured at Sutro’s Facility or at the Alternate Supplier’s facilities (and to the extent Extract from the Alternate Supplier is ordered under this Supply Agreement or the Phase 3/Commercial Supply Agreement, the facility of the Alternate Supplier shall be deemed a Facility for purposes of this Supply Agreement and the Phase 3/Commercial Supply Agreement). Notwithstanding the foregoing, to the extent the FDA and EMA have confirmed that Extract manufactured at Sutro’s Facility and the Alternate Supplier’s Facility are interchangeable and can be supplied from either such Facility without any additional regulatory requirements or regulatory delay with respect to the applicable Vaccine Composition, and such Extract otherwise meets SutroVax’ requirements, then with SutroVax’ consent (not to be withheld unreasonably) Sutro may supply Extract from either Sutro’s Facility or the Alternate Supplier’s Facility.
Appears in 3 contracts
Sources: Supply Agreement (Vaxcyte, Inc.), Supply Agreement (Vaxcyte, Inc.), Supply Agreement (SutroVax, Inc.)