CHANGES IN SPECIFICATIONS. 4.6.1 TRANSMEDICS shall have the right to make other changes to the Product Specifications, the Material Specifications, and the Testing Specifications (collectively, the “Specifications”) at any time. Any increase in costs for the manufacture of the Products by FRESENIUS as a result of such changes in the Specifications as well as any FRESENIUS internal and out-of-pocket cost to implement said changes by FRESENIUS shall be borne by TRANSMEDICS. FRESENIUS shall advise TRANSMEDICS of such cost prior to implementation of the changes to the Specifications requested by TRANSMEDICS and FRESENIUS shall not commence to implement any such changes or incur any costs until TRANSMEDICS has given its written authorization to do so. The Parties shall further agree on a reasonable time schedule for the implementation of said changes. 4.6.2 TRANSMEDICS shall reimburse FRESENIUS for the reasonable costs related to new labels, package inserts or packaging materials or changes to existing labels, package inserts, or packaging materials that are requested by TRANSMEDICS. 4.6.3 TRANSMEDICS shall reimburse FRESENIUS for direct costs of inventories and for costs of destruction thereof, of manufacturing materials, including printed materials, which become obsolete due to changes in Specifications made at the request of TRANSMEDICS. 4.6.4 FRESENIUS may make changes to the Manufacturing Process only with the prior written consent of TRANSMEDICS. Any increased costs resulting from any changes to the Manufacturing Process arising from a request from FRESENIUS shall be borne by FRESENIUS. Unless subject to section 14.1, any benefit arising from a request by FRESENIUS shall be to the benefit of FRESENIUS. 4.6.5 The Parties shall cooperate to determine an appropriate qualification protocol for all changes to Product Specifications. 4.6.6 The Parties shall determine an appropriate inventory level of pre-change Products in order to cover on-going requirements during the qualification process.
Appears in 3 contracts
Sources: Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.), Development and Supply Agreement (TransMedics Group, Inc.)