Specification and Process Changes Clause Samples
The "Specification and Process Changes" clause defines the procedures and rights related to modifying the technical specifications or processes outlined in an agreement. Typically, this clause allows one or both parties to propose changes, which may require mutual consent or follow a formal change order process. For example, if a client requests a new feature or adjustment to a product's design, this clause would govern how that request is evaluated, approved, and implemented. Its core function is to provide a structured method for managing changes, ensuring that both parties have clarity and agreement on any alterations, thereby minimizing disputes and maintaining project alignment.
Specification and Process Changes. In the event that (i) Trubion is required to change Bulk Drug Specifications or a Manufacturing Process pursuant to applicable Legal Requirements or in response to the order or request of a governmental authority or regulatory body, or (ii) Trubion wishes to change Bulk Drug Specifications or a Manufacturing Process, the following provisions will apply:
(1) Trubion shall promptly advise Lonza in writing of any such change(s), and Lonza shall promptly advise Trubion as to scheduling and/or Product Price adjustments, if any, which may result from such change(s). The notification and approval procedure shall be in accordance with the Quality Agreement and with written processes and procedures (i.e., change control procedures) agreed upon by Trubion and Lonza from time to time.
(2) Prior to implementation of such change(s), Trubion and Lonza agree to negotiate in good faith in an attempt to reach agreement on (i) the new Product Price, if any, for any Bulk Drug manufactured under this Agreement by Lonza which embodies such change(s), giving due consideration to the effect of such change(s) on Lonza's direct manufacturing costs for Bulk Drug, and (ii) any other amendments to this Agreement which may be necessitated by such changes (e.g., an adjustment to the manufacturing schedule).
(3) Prior to implementation of such change(s), Lonza will provide Trubion with an estimate of the reasonable and necessary expenses that would be incurred by Lonza as a result of the implementation of any such change(s). If such change(s) are implemented, Trubion will reimburse Lonza for the reasonable and necessary expenses as agreed upon in advance and incurred by Lonza as a result of any such change(s).
(4) If any such change(s) to the Bulk Drug Specifications or a Manufacturing Process renders obsolete or unusable any raw materials, components or supplies used to manufacture Bulk Drug, and to the extent such materials may not be either returned to the appropriate vendor for a credit or utilized by Lonza for its other manufacturing operations, Trubion shall purchase from Lonza, at Lonza's Acquisition Cost, that amount of inventory so rendered obsolete or unusable, not to exceed the amount of such raw materials, components or supplies which would have been required for Lonza to manufacture and supply the total quantity of Bulk Drug specified in Firm Orders currently pending and not yet filled hereunder.
(5) Lonza shall use best efforts to accommodate changes described in Section 6...
Specification and Process Changes. In the event that (i) any amendments are made to the Documentation, (ii) any additional Testing for the Material, any licensing or any other procedure is deemed necessary by Dermata to comply with Applicable Laws, (iii) or any changes to the Documentation are requested by any Regulatory Authority or by Dermata in response to findings resulting from a quality audit, and any of (i) to (iii) require changes to the Collection, Processing, or Testing or the Spongilla, or to the Facility, the Testing Facility or Reka-Farm’s other activities under this Agreement, Dermata promptly shall provide Reka-Farm with a description of such changes. Reka-Farm shall use Commercially Reasonable Efforts to implement such changes in accordance with the change control procedures specified in the Quality Agreement, at Reka-Farm’s sole cost. In the event Reka-Farm demonstrates through written evidence that its operations are not capable of incorporating the proposed changes within the timeframe requested to comply with such changes, then the Parties will engage in good faith discussions with respect to the identification and implementation of arrangements that will permit Reka-Farm to incorporate the proposed changes into its operations.
Specification and Process Changes. In the event that (i) Trubion is required to change Bulk Drug Specifications or a Manufacturing Process pursuant to applicable Legal