Common use of Second Source Manufacturer Clause in Contracts

Second Source Manufacturer. 3.7.1 BI Austria acknowledges that it is critical that InterMune be ensured continuity of supply of PRODUCT for use in clinical trials and market supply. BI Austria 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 Austria’s ability to manufacture and supply PRODUCT shall be carefully observed. Should at any time BI Austria have any indication that continuity of supply can not be ensured, BI Austria shall immediately inform InterMune 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. 3.7.2 In the event the STEERING COMMITTEE decides that it is appropriate for InterMune to establish a second source manufacturer, InterMune agrees to provide the first opportunity to qualify as a second source manufacturer for PRODUCT to a BI Austria AFFILIATE. If such an AFFILIATE is – as foreseeable — unable to supply InterMune’s PRODUCT requirements then InterMune shall be free to choose an alternate supplier. In this case BI Austria shall assist InterMune 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 InterMune’s cost. 3.7.3 In addition, the parties, through the STEERING COMMITTEE shall work together in good faith to develop a risk mitigation plan to minimize 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.

Second Source Manufacturer. 3.7.1 BI Austria acknowledges that it is critical that InterMune be ensured continuity of supply of DRUG PRODUCT for use in clinical trials and market supply. BI Austria shall ensure continuity of supply of DRUG PRODUCT for use in clinical trials and market supply. Nevertheless, due to the potentially growing market demand of DRUG PRODUCT, BI Austria’s ability to manufacture and supply DRUG PRODUCT shall be carefully observed. Should at any time BI Austria have any indication that continuity of supply can not be ensured, BI Austria shall immediately inform InterMune thereof in writing. In this event the matter would be immediately forwarded to the STEERING COMMITTEE to discuss second source manufacture of DRUG PRODUCT reasonably and in good faith. 3.7.2 In the event the STEERING COMMITTEE decides that it is appropriate for InterMune to establish a second source manufacturer, InterMune agrees to provide the first opportunity to qualify as a second source manufacturer for PRODUCT to a BI Austria AFFILIATE. If such an AFFILIATE is – — as foreseeable — unable to supply InterMune’s DRUG PRODUCT requirements then InterMune shall be free to choose an alternate supplier. In this case BI Austria shall assist InterMune 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 InterMune’s cost. 3.7.3 In addition, the parties, through the STEERING COMMITTEE shall work together in good faith to develop a risk mitigation plan to minimize any risk of interruption in the supply of DRUG PRODUCT for use in clinical trials and market supply, which plan may include, among other things, production of excess DRUG PRODUCT or materials relating thereto (e.g., BBSDRUG SUBSTANCE) that can be used as a buffer and/or the off-site storage of certain DRUG PRODUCT or materials relating thereto.