Provision Language
Definitions
“Relevant Regulatory Authority” shall mean (i) in relation to a particular country in the Territory, any applicable federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Products in that country, or (ii) WHO pre-qualification programme where such approval has been deemed adequate by the authority referred to in (i).
“Territory” shall mean all low- and middle-income countries, as defined by the World Bank.
3. OBLIGATIONS OF MPP
MPP undertakes to:
[…]
3.3 Work with WHO to facilitate the strengthening of the Relevant Regulatory Authority as may be required in the Territory to enable Regulatory Approval of the vaccine and facilitate WHO prequalification.
4. OBLIGATIONS OF BIOVAC
Biovac undertakes to:
[….]
4.6 In the event that Biovac develops and commercialises a Product that is responsive to a Public Health Emergency of International Concern as declared by WHO, to as soon as practically possible make available no less than ten percent of its real-time production capacity of Product for WHO and/or Public Sector Agencies at a price to be negotiated in good faith, but in no event to exceed its Cost of Production plus a twenty percent mark-up.
4.7 In the event that Biovac uses the Technology to commercialise a Product, file for WHO Pre-Qualification or Emergency Use Listing, if available and appropriate.