Antibody Raw Material definition

Antibody Raw Material means the bulk Antibody Product, manufactured and quality control tested in accordance with Article 6 (including, if appropriate, [*] and suitable for use in the manufacture of Antibody Product in Finished Form.
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Antibody Raw Material means the bulk Licensed Antibody Product (including, if appropriate, [*] suitable for use in the manufacture of Licensed Antibody Product in Finished Form.
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Antibody Raw Material means the bulk Antibody Product, manufactured and quality control tested in accordance with Article 6
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Examples of Antibody Raw Material in a sentence

  • The Manufacturing Lead in the case of Antibody Raw Material and Amgen in the case of Antibody Products in Finished Form (as appropriate) shall be responsible for obtaining all necessary Regulatory Approvals to enable it to supply the same as specified in Article 6.

  • The terms and conditions of such Commercialisation Supply Agreements shall include the cost and specification of the Antibody Raw Material, commercial quality standards and the method of forecasting demand to be used during Commercialisation.

  • All amounts recovered from the Third Party by way of damages as a result of any breach by the Third Party supplier in the supply of Antibody Raw Material shall be revenues included in the calculation of the Product Contribution.

  • Celltech shall not enter into any Supply Agreement with a Third Party for Antibody Raw Material as specified in this Article 6 without first obtaining the consent of Amgen to such agreement (such consent not to be unreasonably withheld or delayed).

  • Such Third Party supplier or suppliers is herein referred to as the “Manufacturing Lead” for Antibody Raw Material, unless a Party assumes manufacture of Antibody Raw Material pursuant to Article 6.7 below, in which case such Party shall be responsible for the supply of Antibody Raw Material and shall be designated the “Manufacturing Lead”.

  • Antibody Raw Material, in the case of the Manufacturing Lead, and Antibody Products in Finished Form, in the case of Amgen, shall be manufactured in accordance with current GMP in manufacturing processes and facilities as described in the applicable Regulatory Filings submitted to and approved by the Regulatory Authority.

  • The costs of manufacture, including scale-up and validation of Antibody Raw Material and Antibody Product in Finished Form, shall be deemed Research and Development Costs of Late Stage Development to the extent only that Antibody Raw Material and Antibody Product in Finished Form so produced is not used for Commercialisation and otherwise shall be a Cost of Goods.

  • The Parties acknowledge that, in order to meet regulatory requirements prior to the commencement of any supply of Antibody Raw Material or Antibody Product in Finished Form, appropriate quality assurance agreements relating to such supply must be entered into between the Parties and between each Party and its Third Party manufacturers.

  • The terms and conditions of such Development Supply Agreements shall include the cost and specification of the Antibody Raw Material, the quality standards and the method of forecasting demand to be used during Development.

  • Notwithstanding the above, and unless Amgen is the Manufacturing Lead, Celltech shall have exclusive responsibility for all correspondence and for any official communications with Regulatory Authorities in the Territory in connection with the supply of Antibody Raw Material and as reasonably required to meet its obligations with respect to any such supply under this Agreement.