Manufacturing Documents. The aforementioned in Section 4.2 notwithstanding, in order to help preserve the proprietary nature of Can-Fxxx’ s manufacturing information relating to the Product (e.g., the respective CMC section contained in any Regulatory Filings), Can-Fxxx will have the right, to the extent permitted by Regulatory Authorities, to file a drug master file with a Regulatory Authority to make the information regarding such manufacturing information available directly to the Regulatory Authority; provided, however, for the Territory, KDP will have the right to access and reference the drug master file registration number in its Regulatory Filing for the Product, including said CMC section and documentation, to the extent required by law, rule, regulation or a Regulatory Authority having jurisdiction in the Territory. Notwithstanding anything to the contrary herein, KDP will only be entitled to use the manufacturing information relating to the Product to the extent reasonably required by local or national law, rule, regulation or Regulatory Authority and to carry out its development and commercialization activities hereunder
Manufacturing Documents. Somnus shall deliver copies of documents relating to the manufacture of Somnus' Model S2 RF generator, limited to the following: documents of materials, suppliers, all phases of manufacturing, and all manufacturing, quality assurance test procedures and source code for all software related to Somnus' Model S2 generator.
Manufacturing Documents. 8.1. Supplier is obligated to keep the following documents for each component: • work plan • test schedule • process parameters, where applicable
Manufacturing Documents. 5.1. Supplier will receive all the relevant documents on product manufacturing from the Orderer. If the documents provided for the manufacture of parts are incomplete, Supplier shall be obliged to ask the Orderer for the missing documents. If the information and/or instructions and rules contradict each other or are unclear, Supplier will be obliged to clarify these discrepancies with the Orderer.
Manufacturing Documents. For the purpose of quality and regulatory audits and reviewing customer complaints, during the Term of this Umbrella Agreement, Aroa shall promptly furnish TELA Bio with copies of all Manufacturing Documents relating to the Products upon TELA Bio’s request.
Manufacturing Documents. In order to help preserve the proprietary nature of Nuvelo’s manufacturing information (e.g., the CMC section contained in any Regulatory Filings), Nuvelo will have the right, to the extent permitted by Regulatory Authorities, to file a drug master file with a Regulatory Authority to make the information regarding such manufacturing information available directly to the Regulatory Authority; provided however, for all countries in the Bayer Territory, Bayer will have the right to access and reference the Regulatory Filing, including the CMC section and documentation, to the extent required by law, rule, regulation or a Regulatory Authority having jurisdiction in each country in the Bayer Territory. Bayer will only be entitled to use the manufacturing information to the extent reasonably required by local law, rule, regulation or Regulatory Authority and to carry out its Development responsibilities.
Manufacturing Documents. With the help of the manufacturing documents it must be possible to request, order and produce the required components as well as to assemble the WECSs according to the Licensor’s standards.
Manufacturing Documents. Service Provider will maintain all manufacturing documents in accordance with Document Control SOPs such that any documents relating to EPIK IMPLANT systems will be available for MAKO Surgical’s approval and requests for modification. Service Provider will maintain, under their Document Control System, an approved copy of MAKO Surgical’s current manufacturing Device Master Record (“DMR”) including all documentation related to the manufacture of the EPIK. Copies of the master documents used to manufacture the EPIK per the approved DMR will be forwarded to MAKO Surgical upon release. At a minimum, Service Provider will maintain: • Bills of Materials • Component and Finished Goods Drawings and specifications • EPIK product Travelers or Routers • Manufacturing Instructions • Process Specifications [***] Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. • Process and tooling validations • Incoming, in-process, and final acceptance tests • Certificates of Compliance • Device History Records • Approved supplier lists • Inspection tool calibration records • Manufacturing plan / flowchart
Manufacturing Documents. Within [***] after the Effective Date (with respect to such Existing Manufacturing Inventory) and within [***] after such sale (with respect to such In Process Manufacturing Inventory), Blueprint will also transfer (or cause to be transferred) to Clementia copies of Blueprint’s Manufacturing records relating to such supply, including copies of the applicable batch records, in-process and release test results, and certificates of analysis and, to the extent applicable, release with respect thereto (the “Manufacturing Documents”); provided, however, that in no event shall Blueprint be required to transfer any of its CMO’s confidential or proprietary information.
Manufacturing Documents. Solartech shall make available documents relating to the manufacture of the Solartech Meters to the extent such documents exist, including without limitation: documents of materials, suppliers, all phases of manufacturing, Except for the Erythemal subassembly Detector componentry.
