Secondary Manufacturing definition

Secondary Manufacturing means the manufacturing and packaging process used in formulating the active drug substance and all excipients into a final dosage form of a pharmaceutical product.
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Secondary Manufacturing means the formulation, filling, finishing and packaging of Bulk Product to create Finished Product.
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Secondary Manufacturing means the blending of the monovalent Product, e.g. [***] Monovalent, to form trivalent Product, and the filling, finishing and packaging of such trivalent Product to create Finished Product.
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Examples of Secondary Manufacturing in a sentence

  • Bayer will be responsible for the Secondary Manufacturing within Section 1.2.117(b) of the Initial Licensed Products and market release in the Bayer Territory.

  • GSK shall obtain (with reasonable assistance from ALLERGAN) any necessary Marketing Authorizations from the Regulatory Authority in the Territory prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities.

  • GSK acknowledges that ALLERGAN intends to add, within the next three years, an additional production line at the Secondary Manufacturing Facility at Westport, Ireland, ("CORE 3") and an additional API Manufacturing Facility.

  • ALLERGAN shall obtain any necessary Manufacturing Authorizations from the Regulatory Authority in the country of Manufacture prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities.

  • Patheon shall store the Components at Patheon’s storage facility at the Manufacturing Site or the Secondary Manufacturing Site and shall ensure that the Components do not become subject to any lien or other security interest.

  • The Parties will use commercially reasonable efforts to negotiate and complete within [ * ] after the Effective Date a manufacturing agreement pursuant to which ZGEN will manufacture, through a Third Party manufacturer, and supply to Bayer throughout the Term Bulk Drug Substance to be used in Secondary Manufacturing (the “Bulk Drug Substance Supply Agreement”).

  • Patheon shall conduct all Manufacturing Services at the Manufacturing Site or the Secondary Manufacturing Site and may change the Manufacturing Site and the Secondary Manufacturing Site for the Products only with the prior written consent of Client, such consent not to be unreasonably withheld.

  • Patheon shall conduct chemical identity testing for all Active Materials received at the Manufacturing Site or the Secondary Manufacturing Site, as applicable, within twenty (20) days of such receipt.

  • ALLERGAN will be solely responsible for obtaining necessary Manufacturing Authorizations in the country of Manufacture for Manufacturing the Product at any Secondary Manufacturing Facility and the API at any API Manufacturing Facility.

  • Finished Product shall be shipped ex works Aviron's applicable Secondary Manufacturing site.


More Definitions of Secondary Manufacturing

Secondary Manufacturing means (a) the process of producing Licensed Product for the Bayer Territory in finished form, including filling and freeze-drying of Bulk Drug Substance or (b) secondary packaging with ancillary supplies and labeling for sale to or use by an end user of Licensed Product in the Bayer Territory or (c) both.
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