Common use of Regulatory Correspondence Requiring a Lonza Response Clause in Contracts

Regulatory Correspondence Requiring a Lonza Response. In the event that Lonza receives any regulatory letter or comments from any federal, state, local, or foreign regulatory authority directed to its manufacture of Bulk Drug requiring a response or action by Lonza, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Trubion promptly will provide Lonza with any data or information required by Lonza in preparing any response relating to Lonza's manufacture of Bulk Drug, and will cooperate fully with Lonza in preparing such response. Except to the extent prohibited by Legal Requirements, Lonza shall provide Trubion with a copy of each such response for Trubion's review and comment prior to Lonza's submission of its detailed written response. Lonza shall give all due consideration to any Trubion comments to each such proposed Lonza response, provided Trubion timely responds. Likewise, in the event Trubion receives any regulatory letter or comments from any federal, state or local regulatory authority directed to the manufacture of Bulk Drug at the Lonza Facility requiring a response or action by Trubion, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Lonza will promptly provide Trubion with relevant data or information sufficient for Trubion to prepare any response related to the manufacture of Bulk Drug and will cooperate fully with Trubion in preparing such response. Except to the extent prohibited by Legal Requirements, Trubion shall provide Lonza with a copy of each such response for Lonza's review and comment prior to Trubion's submission of its detailed written response. Trubion shall give all due consideration to any Lonza comments to each such proposed Trubion response, provided Lonza timely responds.

Regulatory Correspondence Requiring a Lonza Response. In the event that Lonza receives any regulatory letter or comments from any federal, state, local, or foreign regulatory authority directed to its manufacture of Bulk Drug requiring a response or action by Lonza, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Trubion promptly will provide Lonza with any data or information required by Lonza in preparing any response relating to Lonza's manufacture of Bulk Drug, and will cooperate fully with Lonza in preparing such response. Except to the extent prohibited by Legal Requirements, Lonza shall provide Trubion with a copy of each such response for Trubion's review and comment prior to Lonza's submission of its detailed written response. Lonza shall give all due consideration to any Trubion comments to each such proposed Lonza response, provided Trubion timely responds. Likewise, in the event Trubion receives any regulatory letter or comments from any federal, state or local regulatory authority directed to the manufacture of Bulk Drug at the Lonza Facility requiring a response or action by Trubion, including, but not CONFIDENTIAL AND PROPRIETARY limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Lonza will promptly provide Trubion with relevant data or information sufficient for Trubion to prepare any response related to the manufacture of Bulk Drug and will cooperate fully with Trubion in preparing such response. Except to the extent prohibited by Legal Requirements, Trubion shall provide Lonza with a copy of each such response for Lonza's review and comment prior to Trubion's submission of its detailed written response. Trubion shall give all due consideration to any Lonza comments to each such proposed Trubion response, provided Lonza timely responds.

Regulatory Correspondence Requiring a Lonza Response. In the event that Lonza receives any regulatory letter or comments from any regional, national, federal, state, local, state or foreign local regulatory authority in the Territory directed to its manufacture of Bulk Drug requiring a response or action by Lonza, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Trubion Genentech will, to the extent within its control or possession, promptly will provide Lonza with any data or information required by Lonza in preparing any response relating related to Lonza's ’s manufacture of Bulk Drug, Drug and will cooperate fully with Lonza in preparing such response. Except to the extent prohibited by Legal Requirements, Lonza shall provide Trubion Genentech with a copy of each such response (redacted to remove information not related to the manufacture of Bulk Drug or Lonza’s other obligations under this Agreement) for Trubion's Genentech’s review and comment prior to Lonza's ’s submission of its detailed written response. Lonza shall give all due consideration to any Trubion Genentech comments to each such proposed Lonza response, response provided Trubion Genentech timely responds. Likewise, in the event Trubion Genentech receives any regulatory letter or comments from any regional, national, federal, state or local regulatory authority in the Territory directed to the manufacture of Bulk Drug at the Lonza Facility requiring a response or action by TrubionGenentech, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a Warning Letter, Lonza will will, to the extent within its control or possession, promptly provide Trubion Genentech with relevant data or information sufficient for Trubion Genentech to prepare any response related to the manufacture of Bulk Drug and will cooperate fully with Trubion Genentech in preparing such response. Except to the extent prohibited by Legal Requirements, Trubion Genentech shall provide Lonza with a copy of each such response (redacted to remove information not related to the manufacture of Bulk Drug at Lonza’s Facility or Genentech’s obligations under this Agreement) for Lonza's ’s review and comment prior to Trubion's Genentech’s submission of its detailed written response. Trubion Genentech shall give all due consideration to any Lonza comments to each such proposed Trubion response, Genentech response provided Lonza timely responds.