definiens: shall mean ( i ) one hundred percent ( 100 % ) of those costs incurred by [COMPANY] or [COMPANY] under the Development Program for the design, development and manu facturing scale -up of the Reagents, the design, development and manufacturing scale -up of the Testing Device ; ( ii ) one hundred percent ( 100 % ) of the costs, not to exceed [ CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION ], incurred by [COMPANY] for the clinical trials and regulatory approval of the Product for use in the Field in the United States of America ; ( iii ) one hundred percent ( 100 % ) of the costs, not to exceed [ CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISS ION ] in the aggregate, incurred by [COMPANY] for the clinical trials and regulatory approval of the Product for use in the Field in Europe, Latin America and South Africa ; and ( iv ) thirty percent ( 30 % ) of those costs paid by [COMPANY] to LRE to fund the developm ent of the Reader under the Reader Development and Supply Agreement . The parties currently estimate that the Jointly Funded Development Costs shall be approximately US$ 5,300,000