Common use of Second Source Manufacturer Clause in Contracts

Second Source Manufacturer. 3.6.1 BI RCV acknowledges that it is critical that VIDARA be ensured continuity of supply of PRODUCT for use in clinical trials and market supply. BI RCV shall ensure continuity of supply of PRODUCT for use in clinical trials and market supply. Nevertheless, due to the potentially growing market demand of PRODUCT, BI RCV’s ability to manufacture and supply PRODUCT shall be carefully observed. Should at any time BI RCV have any indication that continuity of supply can not be ensured, BI RCV shall immediately inform VIDARA thereof in writing. In this event the matter would be immediately forwarded to the STEERING COMMITTEE to discuss second source manufacture of PRODUCT reasonably and in good faith. 3.6.2 In the event the STEERING COMMITTEE decides that it is appropriate for VIDARA to establish a second source manufacturer, VIDARA agrees to provide the first opportunity to qualify as a second source manufacturer for PRODUCT to a BI RCV AFFILIATE. If such an AFFILIATE is – as foreseeable – unable to supply VIDARA’s PRODUCT requirements then VIDARA shall be free to choose an alternate supplier. In this case BI RCV shall assist VIDARA in transferring the MANUFACTURING PROCESS to a third party supplier by providing reasonable technical assistance and documentation as necessary for a transfer to a party well skilled in the manufacture of such biotech products at VIDARA’s cost. 3.6.3 In addition, the parties, through the STEERING COMMITTEE shall work together in good faith to develop a risk mitigation plan to minimise any risk of interruption in the supply of PRODUCT for use in clinical trials and market supply, which plan may include, among other things, production of excess PRODUCT or materials relating thereto (e.g., BBS) that can be used as a buffer and/or the off-site storage of certain PRODUCT or materials relating thereto.