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:
Specification and Process Changes. In the event that (i) Immunex is --------------------------------- required to change the Bulk Drug Specifications or the Manufacturing Process pursuant to applicable 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) 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 the Manufacturing Process after commencement of Commercial Production hereunder, the following provisions will apply:
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.
