Validation Work or Additional Testing. It is understood by the parties hereto that the responsibility for any validation work in connection with the Product shall be the sole responsibility of DPT in accordance with the written Project Protocol establishing methodology and pricing for such services. It is understood between the parties hereto that if DPT is required by a regulatory authority to perform any additional validation studies or additional testing of the Product in order to legitimately continue to engage in the manufacture of the Product for COMPANY and DPT and COMPANY cannot reach an agreement on a written Project Protocol, then DPT shall be under no obligation to continue the manufacture of the Product affected by said regulation.
Appears in 2 contracts
Sources: Manufacturing Agreement (Auxilium Pharmaceuticals Inc), Manufacturing Agreement (Auxilium Pharmaceuticals Inc)