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.
Validation Work or Additional Testing. It is understood by the Parties that the responsibility for any validation work shall be the sole responsibility of Connetics. The parties agree that for any validation work or additional testing in connection with the Product, DPT and Connetics shall enter into a specific written Project Protocol establishing methodology and pricing for such services. It is understood between the Parties 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 Connetics and DPT and Connetics 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.
Validation Work or Additional Testing. It is understood by the parties hereto that the responsibility for any validation work requested by Ascent shall be the sole responsibility of Ascent. Upshxx-Xxxxx xxxll be under no obligation to perform any validation work or additional testing, other than to complete those activities set forth in Schedule E hereto initiated by Upshxx-Xxxxx xxxor to the date hereof, in connection with the Product unless Upshxx-Xxxxx xxx Ascent have entered into a specific written Project Protocol establishing methodology and pricing for such services. It is understood between the parties hereto that if Ascent or Upshxx-Xxxxx xx required by regulatory authority to perform validation studies or additional testing
Validation Work or Additional Testing. Unigene will undertake all validation work as may be required by the NDA, cGMP, the Act or other applicable law, Unigene's SOPs, or as otherwise agreed upon by the parties.
Validation Work or Additional Testing. Eon will undertake all validation work as may be required by the ANDA, CGMP, the Act or other applicable law, Eon's SOPs, or as otherwise agreed upon by the parties.
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 AUXILIUM. The parties agree that for any validation work or additional testing in connection with the Product, DPT and AUXILIUM 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 a regulatory authority to perform validation studies or additional testing in order to legitimately continue to engage in the manufacture of the Product for AUXILIUM and DPT and AUXILIUM 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.
Validation Work or Additional Testing. It is understood by the parties that the responsibility for any validation work relating the activities hereunder shall be the sole responsibility of COMPANY. If COMPANY desires for RENAISSANCE to conduct any validation work or additional testing in connection with the Product, RENAISSANCE and COMPANY shall enter into a specific written Project Protocol establishing methodology and pricing for such services, not to exceed [***]. It is understood between the parties that if RENAISSANCE is required by any Regulatory Authority to perform validation studies or additional testing in order to continue Manufacturing Product in accordance with Applicable Law, and RENAISSANCE and COMPANY cannot reach an agreement on a written Project Protocol, then RENAISSANCE shall be under no obligation to continue to Manufacture the affected Product.
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 CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 240.24b-2. [*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION. written Project Protocol, then DPT shall be under no obligation to continue the manufacture of the Product affected by said regulation.
