Common use of Manufacturing Process Clause in Contracts

Manufacturing Process. New River will use Diligent Efforts to develop a process for the Manufacture of bulk Compound and to scale up such process to a level sufficient to Manufacture and supply clinical and commercial supplies of bulk Compound for the ROW Territory. New River will undertake such development in consultation with the JSC, including the preparation of filings necessary to obtain Regulatory Approval for the Manufacture of bulk Compound for the ROW Territory and the selection of any Third Party Manufacturer. In the event that New River includes the filings referred to in this Section 5.1.1 in Drug Master Files in the US Territory, Shire may reference such Drug Master Files for countries in the ROW Territory in which Shire seeks Regulatory Approval of Collaboration Products; provided, however, that Shire will provide New River with assistance as reasonably requested by New River, and at no cost to New River, to ensure compliance with regulatory requirements in such countries. Once such filings are made, no changes to the process for the Manufacture of bulk Compound for the ROW Territory shall be made without the written consent of Shire, such consent not to be unreasonably withheld, conditioned or delayed; provided that New River will not require the prior written consent of Shire to make changes related to the process for the Manufacture of bulk Compound for the ROW Territory hereunder that are required by a Governmental Authority or applicable Law. New River’s retention of any Third Party Manufacturer to perform any activities under this Section 5.1.1 shall be subject to the prior written approval of Shire, not to be unreasonably withheld, conditioned, or delayed. All costs related to the foregoing activities set forth in this Section 5.1.1 that are additional to any activities set forth in Section 6.1.1 of the US Agreement shall be charged by New River to Shire at [*]

Manufacturing Process. New River will use Diligent Efforts to develop a process for the Manufacture of bulk Compound and to scale up such process to a level sufficient to Manufacture and supply clinical and commercial supplies of bulk Compound for the ROW Territory. New River will undertake such development in consultation with the JSC, including the preparation of filings necessary to obtain Regulatory Approval for the Manufacture of bulk Compound for the ROW Territory and the selection of any Third Party Manufacturer. In the event that New River includes the filings referred to in this Section 5.1.1 6.5.1 in Drug Master Files in the US Territory, Shire may reference such Drug Master Files for countries in the ROW Territory in which Shire seeks Regulatory Approval of Collaboration Products; provided, however, that Shire will provide New River with assistance as reasonably requested by New River, and at no cost to New River, to ensure compliance with regulatory requirements in such countries. Once such filings are made, no changes to the process for the Manufacture of bulk Compound for the ROW Territory shall be made without the written consent of Shire, such consent not to be unreasonably withheld, conditioned or delayed; provided that New River will not require the prior written consent of Shire to make changes related to the process for the Manufacture of bulk Compound for the ROW Territory hereunder that are required by a Governmental Authority or applicable Law. New River’s retention of any Third Party Manufacturer to perform any activities under this Section 5.1.1 6.5.1 shall be subject to the prior written approval of Shire, not to be unreasonably withheld, conditioned, or delayed. All costs related to the foregoing activities set forth in this Section 5.1.1 6.5.1 that are additional to any activities set forth in Section 6.1.1 of the US Agreement shall be charged by New River to Shire at [*].

Manufacturing Process. New River will use Diligent Efforts to develop a process for the Manufacture of bulk Compound and Collaboration Products and to scale up such process to a level sufficient to Manufacture and supply in the US Territory clinical and commercial supplies of bulk Compound for the ROW TerritoryCollaboration Products. New River will undertake such development in consultation with the JSC, including the preparation of filings necessary to obtain Regulatory Approval for the Manufacture of bulk Compound and Collaboration Products for the ROW US Territory and the selection of any Third Party Manufacturer. In the event that New River includes the filings referred to in this Section 5.1.1 6.1.1 in Drug Master Files in the US TerritoryUnited States, Shire may reference such Drug Master Files for countries in the ROW Territory for the purpose of prosecuting Drug Approval Applications in which Shire seeks Regulatory Approval of such countries for Collaboration Products; provided, however, that Shire will provide New River with assistance as reasonably requested by New River, and at no cost to New River, to ensure compliance with regulatory requirements in such countries. Once such filings are made, no changes to the process for the Manufacture of bulk Compound and Collaboration Products for the ROW US Territory shall be made without the written consent of Shire, such consent not to be unreasonably withheld, conditioned or delayed; provided that New River will not require the prior written consent of Shire to make changes related to the process for the Manufacture of bulk Compound for the ROW Territory and/or Collaboration Products hereunder that are required by a Governmental Authority or applicable Law. Schedule 6.1.1 sets forth: (a) a list of each Third Party Manufacturer New River is utilizing as of the Effective Date or intends to use to Manufacture Compound and/or Collaboration Product, and (b) a description of the work to be done by each such Third Party Manufacturer. New River’s retention of any Third Party Manufacturer to perform any activities under this Section 5.1.1 shall be subject to the prior written approval of Shire, not to be unreasonably withheld, conditioned, or delayed. All costs related to the foregoing activities set forth in this Section 5.1.1 ; provided, however, that are additional to any activities set forth in Section 6.1.1 of the US Agreement shall be charged by New River will not need the prior written approval of Shire to Shire at [*]utilize Third Party Manufacturers listed on Schedule 6.1.1 for the indicated Manufacturing activities.