“Good Clinical Practices” shall mean the then current Good Clinical Practices as such term is defined from time to time by the United States Food and Drug Administration (“FDA”) or other relevant governmental authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.

“Good ClinicalManufacturing Practices” shall mean the then current Good ClinicalManufacturing Practices as such term is defined from time to time by the United States Food and Drug Administration (“FDA”)FDA or other relevant governmental authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.

“Good ClinicalLaboratory Practices” shall mean the then current Good Clinical Practicesgood laboratory practice regulations of the FDA as such term is defined from time to time bydescribed in the United States Food and Drug AdministrationCode of Federal Regulations (“FDA”CFR”) or other relevant governmental authority having jurisdiction over the Development, Manufactureany comparable corresponding foreign regulations or sale of Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.their respective successor regulations.