Common use of Assays Clause in Contracts

Assays. If Gen-Probe (i) fails at any time during the Blood Screening Term to maintain the applicable FDA (CBER) license for the facility used to manufacture a Blood Screening Assay (unless Gen-Probe is approved by CBER to manufacture from an alternative location or the Supervisory Board agrees within fifteen (15) days of such event that Gen-Probe shall retain the manufacturing responsibility hereunder); or (ii) fails to supply Novartis within forty-five (45) days after the requested delivery date with Novartis’s monthly requirements for a Blood Screening Assay ordered in accordance with Section 5.3 below, for any three (3) months in any nine-month period (unless the Supervisory Board agrees within fifteen (15) days of such event that Gen-Probe shall retain the manufacturing responsibility hereunder), then Novartis shall have the right to, and if Novartis elects to manufacture or have manufactured, the obligation to use Commercially Reasonable Efforts to, manufacture (or to have manufactured) its requirements of such Blood Screening Assay, to be conducted by the Blood Screening Instruments in the Territory for use in the Blood Screening Field; provided, however, such right of Novartis shall be on an assay-by-assay basis for a failure to supply. In such event, Novartis shall consider in good faith, as its preferred alternative upon Gen-Probe’s request, to take over control of and responsibility for the facility used by Gen-Probe to manufacture the Blood Screening Assays, and Gen-Probe promptly shall provide such reasonable technical assistance, at Gen-Probe’s sole cost, as necessary to enable Novartis to exercise its rights to manufacture (or have manufactured) such Blood Screening Assay.