definiens: means all Product used in clinical trials prior to Customer 's ( or its Affiliates ' or any of their collective licensees ' ) initial submission for regulatory approval of the Product for human therapeutic use in any jurisdiction with the exception of clinical supplies of Product which shall be provided by [COMPANY] during the course of the Project ; and ( v ) provide that [COMPANY] shall be the exclusive manufacturer and/or supplier of all polymer materials utilized in the manufacture of Product whether Product is manufactured by [COMPANY], Customer or a Third Party . If Product is manufactured at a Customer Site, Customer will purchase and [COMPANY] will supply one hundred percent ( 100 % ) of Customer 's volume for polymer materials, provided that ( x ) Customer and [COMPANY] negotiate commercially reasonable polymer prices which are reasonably consistent with the polymer prices [COMPANY] is charging { 00327465.DOCX.2 } 15 FOIA CONFIDENTIAL TREATMENT REQUEST BY BIODELIVERY SCIENCES INTERNATIONAL, INC