Common use of Changes Mandated by Regulatory Authority Clause in Contracts

Changes Mandated by Regulatory Authority. 4.3.1 If Facility, equipment, process or system changes are required of Xxxx as a result of a change in the regulatory requirements of a Regulatory Authority, and such regulatory changes apply solely and specifically to the production and supply of Drug Product, then Dyax and Xxxx will review such requirements and agree in writing to such regulatory changes and the cost to implement the changes, and Dyax shall bear the actual pre-approved costs of those changes. If such changes are initiated by the introduction of another product by another Xxxx client in the facility, than these costs shall be the sole responsibility of Xxxx.

Changes Mandated by Regulatory Authority. 4.3.1 If Facility, equipment, process or system changes changes, including without limitation a change to the Product Specification File, are required of Xxxx Xxxxxxxxxx as a result of a change in the regulatory requirements of a Regulatory Authority, and such regulatory changes apply solely and specifically to the production and supply of Drug Substance and/or Drug Product, then Dyax and Xxxx Xxxxxxxxxx will review such requirements and agree in writing to such regulatory changes and the cost to implement the changes, and Dyax shall bear 100% of the actual pre-approved reasonable costs of those changesthereof. If such changes are initiated by the introduction of another product by another Xxxx client in the facility, than these costs shall be the sole responsibility of XxxxXxxxxxxxxx.