Regulatory Changes
Regulatory Changes. Shall mean any changes in or to a Product, its components or its Regulatory Approval imposed by the applicable Regulatory Agency subsequent to Regulatory Approval, except for changes to Quixil required for Omrix to meet the milestone set forth in Section 4.1(b) of the Supply Agreement. For the avoidance of doubt, changes which Omrix makes for product quality, compliance requirements, ongoing improvement programs related to viral inactivation processes and productivity improvements not imposed...
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Regulatory Changes. Shall mean any changes in or to a Product, its components or its Regulatory Approval imposed by the applicable Regulatory Authority subsequent to Regulatory Approval.
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