Common use of Specification and Process Changes Clause in Contracts

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 6.2(a)(i) hereof as soon as practicable after notice thereof, and shall use best efforts to accomplish such changes within ***, unless otherwise agreed upon by the Parties or required by an applicable regulatory authority. Lonza shall use reasonable efforts to accommodate changes described in Section 6.2(a)(ii) hereof in light of, among other considerations, Lonza's facilities and resource constraints, current operations and commercial goals. Lonza shall cooperate with Trubion in good faith to implement all agreed upon changes to the Bulk Drug Specifications or Manufacturing Process in accordance with the agreed upon schedule. (6) The notification and formal approval procedure for those changes to the Bulk Drug Specifications or Manufacturing Process approved by the Parties under this Section shall be in accordance with the Quality Agreement and written processes and procedures (i.e., change control procedures) agreed upon in writing by the Parties from time to time.

Specification and Process Changes. In the event that (i) Trubion Immunex is --------------------------------- required to change the Bulk Drug Specifications or a the Manufacturing Process pursuant to applicable Legal Requirements law, rule or regulation or in response to the order or request of a governmental authority or in response to the order or request of a governmental authority or regulatory body, or (ii) Trubion Immunex requests the change pursuant to its strategy for global synchronization and worldwide consistency of Product, or (iii) Immunex wishes to change the Bulk Drug Specifications or a the Manufacturing ProcessProcess after commencement of Commercial Production hereunder, the following provisions will apply: (1) Trubion Immunex shall promptly advise Lonza Genentech in writing of any such change(s), and Lonza provide information reasonably necessary for Genentech to evaluate the effect of such change(s), and Genentech shall promptly advise Trubion Immunex as to scheduling and/or Product Purchase 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 standard operating procedures (i.e., change control procedures) agreed upon by Trubion and Lonza 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. (2) Prior to implementation of such change(s)) to the Bulk Drug Specifications or Manufacturing Process, Trubion and Lonza the Parties agree to negotiate in good faith in an attempt to reach agreement on (i) the new Product Price, if any, Purchase Price for any Bulk Drug manufactured under this Agreement by Lonza Genentech which embodies such change(s)change, giving due consideration to the effect of such change(s) change on LonzaGenentech'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)changes. (3) Prior to implementation of such change(s), Lonza Genentech will provide Trubion Immunex with an estimate of the reasonable and necessary expenses that would be incurred by Lonza Genentech 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, capital expenditure costs, and [*], as defined in Section 3.9 ----------- above. If such change(s) are implemented, Trubion Immunex will reimburse Lonza Genentech for the reasonable and necessary expenses as agreed upon in advance and incurred by Lonza Genentech as a result of any such change(s). (4) If any such change(s) to the Bulk Drug Specifications or Manufacturing Process, including, but not limited to, reimbursing Genentech for its validation and analytical development costs, capital expenditure costs, and Internal Costs. * Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. The omitted portions of this exhibit have been filed separately with the SEC. (4) Genentech shall use Commercially Reasonable Best Efforts to accommodate changes described in Section 6.2(a)(i) hereof as soon ----------------- as practicable after notice thereof, but in any event within [*] days' lead time, unless otherwise agreed upon by the Parties or required by an applicable regulatory authority. Immunex shall not unreasonably require Genentech to implement changes to the Manufacturing Process or Bulk Drug Specifications within such [*]-day period if such changes would typically require Genentech a longer period of time to implement, or that would have a material adverse effect on Genentech's then current operations. Genentech shall use Commercially Reasonable Efforts to accommodate changes described in Section 6.2(a)(ii) and (iii) ---------------------------- hereof in light of, among other considerations, Genentech's facilities and resource constraints, current operations and commercial goals; and notwithstanding the foregoing, Genentech shall not be required to implement any changes to the Manufacturing Process or Bulk Drug Specifications if such changes would have a material adverse effect on Genentech's then current operations. Genentech shall cooperate with Immunex in good faith to implement all agreed upon changes to the Bulk Drug Specifications or Manufacturing Process in accordance with the agreed upon schedule. During the pendency of Genentech implementing any such changes to the Manufacturing Process or Bulk Drug Specifications, Genentech shall produce and Immunex shall purchase Bulk Drug in accordance with the terms of the Agreement. (5) If any such changes to the Bulk Drug Specifications or Manufacturing Process renders obsolete or unusable any raw materialsmaterials (including, without limitation, Specialized Raw Materials), components or supplies used to manufacture the Bulk Drug, and to the extent such materials may not be either returned to the appropriate vendor for a credit or utilized by Lonza Genentech for its other manufacturing operations, Trubion Immunex shall purchase from LonzaGenentech, at LonzaGenentech's Acquisition Cost, that amount of inventory of such raw materials, components or supplies, as the case may be, so rendered obsolete or unusable, not to exceed the amount of such raw materials, components or supplies which would have been required for Lonza Genentech 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 6.2(a)(i) hereof as soon as practicable after notice thereof, and shall use best efforts to accomplish such changes within ***, unless otherwise agreed upon by the Parties or required by an applicable regulatory authority. Lonza shall use reasonable efforts to accommodate changes described in Section 6.2(a)(ii) hereof in light of, among other considerations, Lonza's facilities and resource constraints, current operations and commercial goals. Lonza shall cooperate with Trubion in good faith to implement all agreed upon changes to the Bulk Drug Specifications or Manufacturing Process in accordance with the agreed upon scheduleCommitments outstanding under this Agreement. (6) The notification and formal approval procedure for those changes to the Bulk Drug Specifications or Manufacturing Process approved by the Parties under this Section shall be in accordance with the Quality Agreement and written processes and standard operating procedures (i.e., change ---- control procedures) agreed upon in writing by the Parties Immunex and Genentech from time to time.