Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards or has not received either WHO pre-qualification or FDA conditional approval, as applicable, by the first anniversary of Licensee’s application for WHO pre-qualification or FDA conditional approval for a Product, Gilead and/or MPP may elect, in their sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of the licenses granted hereunder until such time as Gilead and/or MPP have determined that Licensee has corrected any such failure to Gilead’s and/or MPP's reasonable satisfaction. During any such suspension, Gilead and/or MPP and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.
Appears in 5 contracts
Samples: License Agreement, License Agreement, License Agreement
Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards or has not received either WHO pre-qualification or FDA conditional approval, as applicable, by the first anniversary of Licensee’s application for WHO pre-qualification or FDA conditional approval for a Product, Gilead and/or MPP may elect, in their sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the effectiveness of the licenses granted hereunder until such time as Gilead and/or MPP have determined that Licensee has corrected any such failure to Gilead’s and/or MPP's reasonable satisfaction. During any such suspension, Gilead and/or MPP and Licensee shall coordinate with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension.suspension.
Appears in 1 contract
Samples: License Agreement