Specification and Manufacturing Process Changes Clause Samples
The "Specification and Manufacturing Process Changes" clause defines the procedures and requirements for making alterations to product specifications or the manufacturing process during the course of a contract. Typically, this clause outlines how proposed changes must be communicated, reviewed, and approved by the relevant parties, and may require written consent before any modifications are implemented. Its core practical function is to ensure that both parties maintain control and oversight over product quality and consistency, minimizing the risk of misunderstandings or defects resulting from unapproved changes.
Specification and Manufacturing Process Changes. Except as otherwise set forth to the contrary in the Quality Agreement, the Parties agree as follows:
Specification and Manufacturing Process Changes. Except as otherwise expressly set forth to the contrary in the Quality Agreement, in the event that (i) Genentech is required, or desires, to change the Bulk Drug Specifications or the Manufacturing Process Lonza shall use Commercially Reasonable Best Efforts to accommodate such request, subject to the following:
(a) Genentech shall promptly advise Lonza in writing of any such change(s), and provide information reasonably necessary for Lonza to evaluate the effect of such change(s), and Lonza’ shall promptly advise Genentech as to scheduling changes, if any, which may result from such change(s). The notification and approval procedure shall be in accordance with standard operating procedures (i.e., change control procedures) agreed upon by the Parties from time to time. The Parties shall hold a JPT meeting in a timely manner with appropriate advisors invited to discuss such changes as appropriate.
(b) Prior to implementation of any such material change(s) to the Bulk Drug Specifications or Manufacturing Process, the Parties agree to negotiate in good faith in an attempt to reach agreement on (i) the new Purchase Price (higher or lower) for any Bulk Drug manufactured under this Agreement by Lonza which embodies such material change, giving due consideration to the effect of such material change on Lonza’s direct manufacturing costs for Bulk Drug, and (ii) any other amendments to this Agreement which may be necessitated by such material changes.
(c) Prior to implementation of any such change(s), Lonza will provide Genentech 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) to the Bulk Drug Specifications or Manufacturing Process, including, but not limited to, its validation and analytical development costs, and capital expenditure costs. If such change(s) are implemented, Genentech 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) to the Bulk Drug Specifications or Manufacturing Process, including, but not limited to, reimbursing Lonza for its validation and analytical development costs and capital expenditure costs.
(d) Lonza shall use Commercially Reasonable Best Efforts to promptly accommodate changes described in Section 8.1 hereof in light of Lonza’s facilities and resource constraints and current operations. Lonza shall cooperate with Genentech in good faith to im...
Specification and Manufacturing Process Changes