Manufacturing Data definition

Manufacturing Data means all data, information, material, and documentation developed or generated with respect to the Manufacturing of a pharmaceutical product, including manufacturing and control data and other data and documentation requested by or submitted to a Regulatory Authority.
Manufacturing Data means all chemistry-manufacture-controls (“CMC”) data (including analytical data, test data, quality control data and stability data) and any other data relating directly to manufacture of the Compound or any Licensed Product that are generated by or on behalf of either Party, or jointly by the Parties, in connection with the performance of this Agreement, including the Development or Commercialization of the Compound and any Licensed Products.
Manufacturing Data means all data prepared in connection with the performance of services under this Agreement, including, but not limited to, any reports, drawings, sketches, formulas, designs, analyses, graphs, notes, memoranda and notebooks.

Examples of Manufacturing Data in a sentence

  • Korea, US, Canada, and Australia.Proposals submitted under this topic should include a business case and exploitation strategy, as outlined in the introduction to this Destination.Proposals should take into account relevant international standards and activities supported under the Digital Europe programme, e.g. in the area of Manufacturing Data Spaces.Research must build on existing standards or contribute to standardisation.

  • The SUPPLIER shall submit the required project documentation and Manufacturing Data Records as specified within the COMPANY ‘Information Requirements – Appendix 3 (Ref.

  • As-built documents incorporating all new and existing equipment shall be submitted in a Manufacturing Data Book (MDB) of which the index shall be submitted for approval prior to delivery.

  • These might include, e.g. Requirement Review (RR), Manufacturing Data Package Review, Preliminary Design Review (PDR), Critical Design Review (CDR), Production Readiness Review (PRR), Test Readiness Review (TRR), Internal Factory Acceptance test (iFAT), Incoming Goods Inspection, Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Harbor Acceptance Test (HAT), Sea Acceptance Test (SAT), Flight Acceptance Test.

  • For clarity, Licensed Know-How includes all Product Inventions, Licensed Territory Data and Results, and subject to the initiation of the Manufacturing Technology Transfer pursuant to Section 8.5, Manufacturing Data, but excludes all Know-How that does not relate to the Compound and relates to another proprietary compound of Mirati or its Affiliates.


More Definitions of Manufacturing Data

Manufacturing Data means all material information and data relating to or used in connection with the manufacturing of Compounds and/or Products by MG or its Affiliates, Additional Partners, or others working under authority of such entities, including without limitation, such information and data as generated or used during process development, stability studies, formulation development, scale-up of manufacturing, production of preclinical and clinical product batches, validation studies, development of quality assurance/quality control testing, and related regulatory affairs; and all information and data contained in the DMF or in the CMC section of an IND or NDA (or their counterparts in other countries) with respect to Compounds and/or Products. Without limiting the foregoing, Manufacturing Data shall include information and data described in Exhibit 1.23. Notwithstanding the foregoing, to the extent MG, Additional Partners and their Affiliates do not have rights to such know-how, the term “Manufacturing Data” shall exclude any proprietary manufacturing know-how described in a DMF that was disclosed by a contract manufacturer of MG, Additional Partners or their Affiliates directly to the Regulatory Authority (and not to MG, Additional Partners or their Affiliates), which know-how had been independently developed by such contract manufacturer outside of its relationship with MG, the Additional Partner or their Affiliates; provided that MG ensures that, upon the request of Taiho, such contract manufacturer shall file with Regulatory Authorities in the Territory a similar DMF containing such know-how in support of Taiho’s regulatory filings.
Manufacturing Data shall have the meaning set forth in Section 7.8.
Manufacturing Data means all Know-How and Technical Information relating to the manufacture of the Licensed Molecules or Licensed Product.
Manufacturing Data means all material information and data relating to or used in connection with the manufacturing of Compounds and/or Collaboration Products by MethylGene or its Affiliates or others working under authority of such entities (but, for the avoidance of doubt, excluding Taiho), including without limitation, such information and data as generated or used during process development, stability studies, formulation development, scale-up of manufacturing, production of preclinical and clinical product batches, validation studies, development of quality assurance/quality control testing, and related regulatory affairs; and all information and data contained in the DMF or in the CMC section of an IND or NDA (or their counterparts in other countries) with respect to Compounds and/or Collaboration Products. Without limiting the foregoing, Manufacturing Data shall include information and data described in Schedule 1-D. Notwithstanding the foregoing, to the extent MethylGene and its Affiliates do not have rights to such know-how, the term “Manufacturing Data” shall exclude any proprietary manufacturing know-how described in a DMF that was disclosed by a contract manufacturer of MethylGene or its Affiliates directly to the Regulatory Authority (and not to MethylGene or its Affiliates), which know-how had been independently developed by such contract manufacturer outside of its relationship with MethylGene or its Affiliates; provided that MethylGene ensures that, upon the request of EVP, such contract manufacturer shall file with Regulatory Authorities in the Territory a similar DMF containing such know-how in support of EVP’s regulatory filings. In addition, notwithstanding the foregoing, Manufacturing Data shall not include information or data generated by a Non-ND Partner or MethylGene “in collaboration with” a Non-ND Partner (as defined above under Licensed MethylGene Technology), by an Opt-Out Non-ND Partner or MethylGene “in collaboration with” an Opt-Out Non-ND Partner (as defined above under Licensed MethylGene Technology) or by MethylGene pursuant to a Bona Fide Internal Research and Development Program.
Manufacturing Data means any and all data, documentation, information and submissions and communications pertaining to, or made in association with any CMC Activities and/ or Manufacture of the Products and/ or Backup Candidates (e.g., master batch records, batch records, in-process controls records, drug master file, Manufacturing process descriptions, release documents, release specifications, release data, process control data, CMC submission documents and communication with Regulatory Authorities relating thereto), including all CMC Information, in each case that are generated in the conduct of activities conducted under the Global Development Plan or otherwise under this Agreement.
Manufacturing Data means all data, information, material, and documentation developed or generated with respect to the Manufacturing of a pharmaceutical product, including without limitation manufacturing and control data and other data and documentation requested by or submitted to a Regulatory Authority. 1.36. “NDA” means a New Drug Application filed with the FDA requesting permission to place a drug on the market in accordance with 21 CFR Part 314, and all amendments or supplements filed pursuant to the requirements of the FDA. 1.37. “NDA Approval” means the approval of an NDA by FDA for the Product in the Territory. 1.38. “NDA Approval Date” means date on which Zosano receives NDA Approval. 1.39. “Net Profit” means Net Sales, less the following: [***]. 1.40. “Net Sales” means the gross invoiced price (not including value added taxes, sales taxes or similar taxes) of Product actually sold to a Customer hereunder after deducting, if not previously deducted, from the amount invoiced or received: a. trade and quantity discounts other than early payment cash discounts that are actually allowed or granted; b. rebates, chargebacks and other allowances that are actually allowed or granted; c. credits or allowances actually given or made by Zosano to Customers for rejection or return of the Products to Zosano; 5
Manufacturing Data means all data prepared in connection with the performance of services under this Agreement, including, but not limited to, any reports, drawings, sketches, formulas, designs, analyses, graphs, notes, memoranda and notebooks. Manufacturing Process: means the sequence of steps beginning at Wafer Dicing and continuing through Final Lot Acceptance Test that is used by Contractor to Manufacture Product.