Validation Campaign definition

Validation Campaign means the validation campaign for Product pursuant to the applicable Statement of Work under the MSA.
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Validation Campaign means three Validation Batches made consecutively, with no failed attempts to make a Validation Batch intervening.
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Examples of Validation Campaign in a sentence

  • Activity 8: Validation Reports 20 working days after completion of Validation Batch #3, or 20 days from date requested by RADIUS Activity 9: Validation Stability Stability study to start within one month of batch purification and continue according to protocol Activity 10: DMF Filing Within 40 working days of date requested by RADIUS, but not earlier than 3.5 months after the end of the Validation Campaign.

  • The parties acknowledge that they may adjust the Product Specifications in accordance with the terms of the Quality Agreement, but not less than [***] prior to the planned commencement of the Process Validation Campaign.

  • Such request shall be made known by Amylin to Sandoz not later than [***] after finalization of the Process Validation Campaign.

  • Attached as Exhibit A hereto is the currently approved budget highlighting the expenses that are scheduled to be incurred in connection with the activities conducted under the Validation Campaign Agreement.

  • Not less than [***] in advance of commencing the Process Validation Campaign, Amylin and Sandoz will agree upon the final Process Validation Protocol in writing.

  • Amylin shall reimburse Sandoz for all costs and expenses, including without limitation capital expenditures, reasonably incurred by Sandoz for the Facility Modifications and for any assets acquired as part of the Facility Modifications as follows: Sandoz shall be entitled to invoice for such costs as a surcharge on each individual Batch of the process Validation Campaign.

  • Furthermore, the parties acknowledge and agree that any and all DX-88 API that is necessary to be used for validation, stability, and other analytical studies that are conducted on behalf of Dyax-Genzyme LLC in connection with the Validation Campaign Agreement or for marketing approval of DX-88 will be taken from the DX-88 API owned and controlled by Dyax-Genzyme LLC.

  • Amylin will establish the Product Specifications in mutual agreement with Sandoz in writing (taking into account the information relating to the Product learned during the Process Characterization Phase) prior to the Process Validation Campaign.

  • PCAS shall deliver to ViroPharma a draft Validation Report within twenty-one (21) days after the shipment of the final Validation Batch in a Validation Campaign.

  • For purposes of manufacture and supply of AGI-1067 under this Agreement (other than for purposes of the AGI-1067 Process Validation Campaign, which are governed by Section 7.2 above), the Parties agree that AGI-1067 Pricing assumptions for the base case are: [****] Dow shall provide reasons for the lower yield and possible steps to increase yield.