“PRV” shall mean the Food and Drug Administration (“FDA”) priority review voucher program in the United States of America.
“Regulatory Advantage” shall mean the PRV or any equivalent incentive program to the PRV from a Regulatory Authority regarding a Product.
8. REGULATORY ADVANTAGE
8.1 The Parties acknowledge that both Parties will actively contribute to the Development and Distribution Program and agree to share the economic benefits of any Regulatory Advantage.
8.2 In the event Partner (or any of its Affiliates) obtains a Regulatory Advantage from the Marketing Authorisation of a Product: a) < to complete >