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
The SUPPLIER shall submit the required project documentation and Manufacturing Data Records as specified within the COMPANY ‘Information Requirements – Appendix 3 (Ref.
Contractor agrees that RFM shall be entitled to receive copies of and use all Manufacturing Data.
Contractor agrees that Company shall be entitled to receive copies of and use all Manufacturing Data for its own benefit.
Contractor hereby grants and agrees to grant to Company a worldwide, non-exclusive right and license to use financial data related to services under this agreement, Manufacturing Data, sales data, tracking data, reports, and other information transferred to or otherwise provided to or for Company for its business purposes.
RFM affirms that Manufacturing Data that constitutes Contractor’s solely owned intellectual property shall remain Contractor’s property, subject only to RFM’s right of use provided in the preceding sentence.
More Definitions of Manufacturing Data
Manufacturing Data means all Know-How and Technical Information relating to the manufacture of the Licensed Molecules or Licensed Product.
Manufacturing Data shall have the meaning set forth in Section 7.8.
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 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 and/or Commercialization of the Compound and any Licensed Products.
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 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 either or both, as the case requires: (i) all data and information (including the Batch Records) related to the conduct of the Manufacturing Process at the Facility that is generated by Wyeth in the performance of its obligations hereunder from the Effective Date through the date of achievement of PAI Readiness and that would be necessary or useful for Genentech to complete the filing of the sBLA with the FDA, including without limitation data related to the Commissioning and validation of the Facility, and/or (ii) all data and information (including the Batch Records) related to the manufacture of Product at the Facility that is generated by Wyeth in the performance of its obligations hereunder following achievement of PAI Readiness and that would be necessary or useful for Genentech to comply with all laws and regulations pertaining to the manufacture, use, storage or sale of Product manufactured by Wyeth under this Agreement.