Provision Language
3. Development and Registration
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3.3 Quality. If Licensee elects to commercialize Licensed Products, Licensee will commercialize the Licensed Products in a manner consistent with: (i) World Health Organization (“WHO”) pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority (“Stringent Regulatory Authority”), as defined by the WHO. Where such approvals are not yet available, the Licensee may obtain temporary approval through a WHO Expert Review Panel.