The United Kingdom and Ireland. In the United Kingdom and the Republic of Ireland, P&G shall undertake all commercially reasonable efforts to obtain all Health Registrations necessary, as the case may be, to market, promote, detail, distribute, sell and, if applicable, manufacture the Product in such countries, as soon as practicable after the Original Agreement Effective Date. If such filings have not been made in any country within three (3) months after the date of filing with the USFDA the NDA or supplemental NDA for PMO for the Product, then API shall have the right, but not the obligation, to undertake the efforts to obtain such Health Registrations. P&G will work with API to develop Health Registration packages and filing strategies for Paget’s disease, PMO, corticosteroid induced osteoporosis and other indications intended to maximize the commercial success of the Product. The parties will cooperate to develop strategies to extend or modify existing Health Registrations for the Product and to obtain Health Registrations for any Joint Product Improvement. If the parties disagree on the content of such Health Registration packages or filing strategies, said disagreement shall be immediately referred to the Oversight Committee Leaders for resolution and the party referring the disagreement to the Oversight Committee Leaders shall give notice of such disagreement to the other party in accordance with Section XXV(M). If the Oversight Committee Leaders or their designees cannot agree within five (5) Business Days of such referral, P&G’s position shall prevail.
