VALIDATION LOT CAMPAIGN Clause Samples

VALIDATION LOT CAMPAIGN. (VLC) (1) Subject to the terms and conditions of this Clause, Alder shall place a written order for the VLC no later than [***] but in no event later than [***]. (2) Subject to (i) successful completion of the DLC (ii) process characterization activities have been completed and concluded no later than [***], (iii) the Analytical Activities have been completed, and in addition (iv) the required documents to start a process validation have been approved by Alder and Sandoz, then Sandoz shall perform a Manufacturing Campaign at the [***] Facility consisting of the number of Engineering Batches and cGMP Batches (subject to adjustment according to Clause 15) as described in Schedule 7 (the “Validation Lot Campaign” or “VLC”) within the Calendar Year following the Calendar Year of performance of the DLC, and will deliver the BDS Batches produced therefrom to Alder (or Alder’s designee) upon completion of such Campaign. Each Party will use Commercially Reasonable Efforts to achieve the goals stated in Clause 7(2) (i), (ii), (iii) and (iv) in a timely manner. Alder is subject to Capacity Fee charges in accordance with Clause 11(2). (3) The Parties acknowledge that additional BDS Batches may be Manufactured as Engineering Batches depending on (i) status and robustness of the Process and (ii) any process changes that may be incorporated based on process characterization studies or other process optimization studies, and (iii) to fulfill the requirements in the process characterization protocol, in order to enable Sandoz to successfully perform the Validation Lot Campaign.