Validation Work or Additional Testing. It is understood by the parties hereto that the responsibility for any validation work shall be the sole responsibility of COMPANY. The parties agree that for any validation work or additional testing in connection with the Product, DPT and COMPANY shall enter into a specific written Project Protocol establishing methodology and pricing for such services. It is understood between the parties hereto that if DPT is required by regulatory authority to perform validation studies or additional testing 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 6 contracts
Samples: Manufacturing Agreement (Anacor Pharmaceuticals, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.), Manufacturing Agreement (Insys Therapeutics, Inc.)
Validation Work or Additional Testing. It is understood by the parties Parties hereto that the responsibility for any validation work shall be the sole responsibility of COMPANYSERENITY. The parties Parties agree that for any validation work or additional testing in connection with the Product, DPT and COMPANY SERENITY shall enter into a specific written Project Protocol establishing methodology and pricing for such servicesservices (the "Project Protocol"). It is understood between the parties Parties hereto that if DPT is required by regulatory authority to perform validation studies or additional testing in order to legitimately continue to engage in the manufacture of the Product for COMPANY SERENITY and DPT and COMPANY SERENITY 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 1 contract
Samples: Manufacturing Agreement (Avadel Pharmaceuticals PLC)