Cooperation in Obtaining Government Approvals. As set forth in the Quality Assurance Agreement, or as otherwise agreed to in writing by CPL and Helix, at Helix's request, CPL shall provide Helix with such existing documents and information (or copies thereof) held by CPL to assist Helix in securing and maintaining Regulatory Authority approvals for the Product. In addition, CPL shall provide Helix with such information as is reasonably requested in writing by Helix relating to the Manufacturing Process, the Master Formula, the Master Packaging Formula / Procedure, the CPL Services performed under this Agreement or other Product-related documentation. Any Helix requests for documents or other work product that do not exist as of the date of such request and are not otherwise required by this Agreement, including the CPL Estimates or Quality Assurance Agreement, or any other substantive requests for assistance in compiling any Regulatory Filing shall be conducted at Helix’s expense.
Cooperation in Obtaining Government Approvals. As set forth in the Quality Assurance Agreement, or as otherwise agreed to in writing by BioVectra and Helix, at Helix's request, BioVectra shall provide Helix with such existing documents and information (or copies thereof) held by BioVectra to assist Helix in securing and maintaining Regulatory Authority approvals for the Product. In addition, BioVectra shall provide Helix with such information as is reasonably requested in writing by Helix relating to the the Master Formula, the Services performed under this Agreement or other Product-related documentation. Any Helix requests for documents or other work product that do not exist as of the date of such request and are not otherwise required by this Agreement, including the schedules hereto, or any other substantive requests for assistance in compiling any Regulatory Filing shall be conducted at Helix’s expense.
Cooperation in Obtaining Government Approvals. As set forth in the Quality Agreement, or as otherwise agreed to in writing by SAFC and Company, at Company’s request, SAFC shall provide Company with such existing documents and information (or copies thereof) held by SAFC to assist Company in securing and maintaining Regulatory Agency approvals for Vector Product. In addition, SAFC shall provide Company with such information as is reasonably requested in writing by Company relating to the Manufacturing Process, the Master Batch Record, SAFC services performed under this Agreement or other ABI-related documentation.
Cooperation in Obtaining Government Approvals. NEKTAR AL shall cooperate with COMPANY, at COMPANY'S request, to enable COMPANY to comply with requirements of HAS to perform clinical trials and obtain MARKETING AUTHORIZATION for the SELECTED PRODUCT, including by providing COMPANY and its SUBLICENSEES and CMOS with a letter authorizing COMPANY and its SUBLICENSEES and CMOS to reference NEKTAR AL'S DMF (provided that COMPANY and its SUBLICENSEES and CMOS will have no direct access to the DMF) and other regulatory filings regarding the SELECTED REAGENT and the like, and to resolve the concerns of HAS with respect to the manufacture or processing of the SELECTED REAGENT prior to its shipment to COMPANY. In the event COMPANY requests technical assistance from NEKTAR AL under this Section 9.2.3, Section 3.8 will apply and a SERVICES AGREEMENT will be required unless such requested assistance does not result in the disclosure of NEKTAR AL CORE TECHNOLOGY or CONFIDENTIAL [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. other material NEKTAR AL CONFIDENTIAL INFORMATION to COMPANY. In any event, COMPANY agrees to reimburse NEKTAR AL for its reasonable costs associated with providing such requested assistance. For clarity, the preparation and filing of a DMF by itself shall not require a SERVICES AGREEMENT.
Cooperation in Obtaining Government Approvals. As set forth in the Quality Agreement, or as otherwise agreed to in writing by CBSB and Tercica, CBSB shall reasonably assist Tercica, at Tercica’s request, CBSB shall provide Tercica with such existing documents and information (or copies thereof) held by CBSB to assist Tercica in securing and maintaining Regulatory Authority approvals for the Product. In addition, CBSB shall provide Tercica with such information as is reasonably requested in writing by Tercica relating to the Manufacturing Process, the Master Production Record, CBSB services performed under this Agreement or other Product-related documentation. Any Tercica requests for documents or other work product that do not exist as of the date of such request or other substantive requests for assistance in compiling any Regulatory Filing shall constitute Additional Services, and CBSB shall notify Tercica of the same, and, if Tercica authorizes such services, CBSB shall invoice Tercica for such Additional Services in accordance with the Project Rates.
Cooperation in Obtaining Government Approvals. As set forth in the Quality Agreement, or as otherwise agreed to in writing by Paragon and Client, Paragon shall provide Client with such existing documents and information (or copies thereof) held by Paragon to assist Client in filing Regulatory Filings and in maintaining Regulatory Authority approvals for the Product. In addition, Paragon shall provide Client with such information for each Project as is reasonably requested in writing by Client relating to the Manufacturing Process, the Master Manufacturing Record, Paragon services performed under this Agreement or other Product-related documentation. Any Client requests for documents or other work product that is not specified or contemplated in the Project Plan or produced by Paragon in the ordinary course of business, or other substantive requests for assistance in compiling any Regulatory Filing shall constitute Additional Services, and Paragon shall notify Client of the same, and, if Client authorizes such services, Paragon shall prepare a Change Order and invoice Client for such Additional Services.
Cooperation in Obtaining Government Approvals. Avecia shall reasonably assist Genta (and, upon Genta's request, the Genta Partners), at Genta's request, to secure and maintain governmental approvals for the Genta Product and shall participate as is reasonably necessary and as may be requested in resolving the concerns of any Regulatory Authority arising with respect to the manufacture of API for Genta. Without limiting the foregoing, Avecia shall produce stability batches and validation batches and perform testing and prepare all necessary documentation as is necessary for Genta and the Principal Genta Partner to receive approvals for Genta Product from Regulatory Authorities.
Cooperation in Obtaining Government Approvals. HTI shall reasonably assist HemoSense, at HemoSense’s request, to secure and maintain governmental approvals for the HemoSense Product and shall participate as is reasonably necessary and as may be requested in resolving the concerns of any regulatory authority arising with respect to the manufacture of Coagulation Cocktail 2 for HemoSense.
Cooperation in Obtaining Government Approvals will reasonably assist SuperGen, at SuperGen’s request, to secure and maintain governmental approvals for the Product and will participate as is reasonably necessary and as may be requested in resolving the concerns of any Regulatory Authority arising with respect to the manufacture of Product for SuperGen. Without limiting the foregoing, *** will produce stability batches and validation batches and perform testing as is necessary for SuperGen to receive approvals for Product from Regulatory Authorities.
Cooperation in Obtaining Government Approvals. Genzyme shall cooperate with Semnur, at Semnur’s request, to enable Semnur to comply with requirements of Regulatory Authorities to perform clinical trials and obtain Regulatory Approval for the Semnur Product, including by providing Semnur and its sublicensees with all information reasonably necessary to provide to the applicable Regulatory Authorities related to the Product, and providing to Semnur or its sublicensees a letter authorizing Semnur and its sublicensees to reference Genzyme’s drug master file (DMF) for the Product (provided that Semnur and its sublicensees will have no direct access to the DMF) and other regulatory filings regarding the Product and the like, and to resolve the concerns of any Regulatory Authority with respect to the manufacture or processing of the Product prior to its shipment to Semnur.
