Regulatory Communications and Correspondence. Any and all communications from and to the FDA or other Regulatory Authorities related to the Product or to the manufacture of the Drug Substance at the LONZA Facility shall be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by LONZA and PROTEON.
Regulatory Communications and Correspondence. Any and all communications from and to the FDA or other Regulatory Authorities related to the Production of the Product at the Facility shall be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by XXXX and CLIENT.
Regulatory Communications and Correspondence. Any and all communications from and to Regulatory Authorities related to this Agreement or the Services hereunder shall be handled as agreed in writing by CPL and Helix.
Regulatory Communications and Correspondence. Any and all communications from and to Regulatory Authorities related to this Agreement or the Services hereunder shall be handled as agreed in writing by BioVectra and Helix.
Regulatory Communications and Correspondence. GENTA shall require each Subcontractor to promptly notify it, and shall itself promptly notify the SUPPLY CHAIN TEAM, of all communications from the FDA or other REGULATORY AUTHORITIES which may impact or change the PROCESSING ACTIVITIES performed by GENTA or such Subcontractor, or affect the ability of GENTA to comply with its obligations under this AGREEMENT. Without limiting the foregoing, GENTA shall require each Subcontractor to notify it, and shall itself notify the SUPPLY CHAIN TEAM, of any written or oral inquiries, notifications or inspection activities by any REGULATORY AUTHORITY in regard to PRODUCT within (*) business days of GENTA or such Subcontractor, as applicable, obtaining knowledge of such inquiries, notifications or inspection activities. Moreover, GENTA shall require each Subcontractor to furnish it with, and shall itself furnish to the SUPPLY (*) Represents language that is redacted and subject to Confidential Treatment. CHAIN TEAM, copies of all inspection reports and related correspondence of such REGULATORY AUTHORITY related to or which might reasonably affect performance of any PROCESSING ACTIVITIES hereunder (including, without limitation, any FDA Form 483 or other inspection reports, warning letters, citations, indictments, claims, lawsuits or proceedings issued or instituted against GENTA or such Subcontractor, or of any revocation of any license or permit issued to GENTA or such Subcontractor) and when such reports and correspondence become available to GENTA, but in any event within (*) days after obtaining knowledge of such inquiries, notifications or inspection activities. GENTA will discuss with the SUPPLY CHAIN TEAM, and will use COMMERCIALLY REASONABLE EFFORTS to cause its Subcontractors to discuss with the SUPPLY CHAIN TEAM, any REGULATORY AUTHORITY comments directly related to and affecting GENTA's or such Subcontractor's performance of any PROCESSING ACTIVITIES, and before GENTA or such Subcontractor submits a final response to such comments, GENTA shall give the SUPPLY CHAIN TEAM, or shall use COMMERCIALLY REASONABLE EFFORTS to cause such Subcontractor to give the SUPPLY CHAIN TEAM, no fewer than (*) business days to comment on its proposed response to such comments, and any resultant SUPPLY CHAIN TEAM comments will be incorporated to the response, if reasonably possible. GENTA shall promptly rectify or resolve, and shall use COMMERCIALLY REASONABLE EFFORTS to cause its Subcontractors to promptly rectify or resolve, ...
Regulatory Communications and Correspondence. Any and all communications from and to Regulatory Authorities related to Vector Product or to the Manufacture of Vector Product at the Manufacturing Facility shall be handled in accordance with the Quality Agreement, or as otherwise agreed in writing by SAFC and Company.
Regulatory Communications and Correspondence. The Lead Regulatory Party shall, within two (2) Business Days, provide to the other Party copies of any material correspondence received from or submitted to the applicable Regulatory Authorities pertaining to each VEGF Product (including, without limitation, any meeting minutes). To the extent a Party is not the Lead Regulatory Party with respect to a VEGF Product, such Party shall use all reasonable efforts to ensure that, except in extraordinary circumstances, such Party will not communicate or correspond with, and will use all reasonable efforts to facilitate the Lead Regulatory Party as the sole party corresponding or communicating with, any Regulatory Authority concerning a VEGF Product; provided, however, that nothing herein shall limit or restrict the right of the Party which is not such Lead Regulatory Party to communicate with any Regulatory Authority in connection with its manufacturing facilities or other operations, unless such communications relate directly to the manufacture, Development, or Commercialization of such VEGF Product. In furtherance of this, the Party which is not the Lead Regulatory Party will take reasonable steps and implement reasonable procedures intended to assure the foregoing.
Regulatory Communications and Correspondence. Except as provided in Section 11.4 (“Regulatory Authority Inspections”), any and all other communications from and to the FDA or other Regulatory Authorities related to the Production of the Product at the Facility shall be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by Catalent and Client.
Regulatory Communications and Correspondence. Any and all communications from and to the FDA or other Regulatory Authorities related to the Product or to the manufacture of the Drug Substance at the CBSB Facility shall be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by CBSB and Tercica.
Regulatory Communications and Correspondence. Any and all communications from and to the FDA or other Regulatory Authorities related to the final dosage form of the Product or to the manufacture of the Product at the Paragon Facility shall be handled in accordance with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by Paragon and Client.
