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 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. 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 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 will promptly notify SuperGen of all communications from and to the FDA or other Regulatory Authorities that may impact or change the manufacturing or processing activities performed by ***, or affect the ability of *** to comply with its obligations under this Agreement. Without limiting the foregoing, *** will notify SuperGen of any written or oral inquiries, notifications or inspection activities by any Regulatory Authority in regard to the Product or the Manufacturing Facility within five (5) days of *** obtaining knowledge of such inquiries, notifications or inspection activities. Moreover, *** will furnish to SuperGen copies of all inspection reports and related correspondence of such Regulatory Authority related to or which might reasonably affect the Product or the performance of any manufacturing or processing activities hereunder (including any FDA Form 483 or other inspection reports, warning letters, citations, indictments, claims, lawsuits or proceedings issued or instituted against ***, or of any revocation of any license or permit issued to ***) and when such reports and correspondence become available to ***, but in any event within five (5) days after obtaining knowledge of such inquiries, notifications or inspection activities. *** will discuss with SuperGen any Regulatory Authority comments directly related to and affecting the Product or ***’s performance of any manufacturing or processing activities hereunder, and before *** submits a final response to such comments, *** will give SuperGen no fewer than five (5) days to comment on its proposed response to such comments, and any resultant SuperGen comments will be incorporated to the response, if reasonably possible. *** will promptly rectify or resolve any deficiencies noted by a Regulatory Authority in a report or correspondence issued to *** that relate to performance of any of the manufacturing or processing activities under this Agreement.
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. 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 the FDA or other Regulatory Authorities related to the manufacture of the Product at the Service Provider facility that are addressed to Service Provider shall be handled in accordance with the terms and conditions of the QAA (if applicable), or shall be handled by Service Provider, incorporating any and all reasonable comments from AstraZeneca as necessary after provision by Service Provider with, to the extent regulatory timelines reasonably permit, a sufficient period of time for such review and comment.
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. 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.
