Manufacturing Procedure definition

Manufacturing Procedure means the agreed upon manufacturing process as detailed in mutually approved batch production records and Batch Documentation including the testing plan, used by BioVectra to manufacture the Product.
Manufacturing Procedure means Celgene's description of the synthesis of Material as provided by Celgene to JMI, attached hereto and incorporated herein as Exhibit A.
Manufacturing Procedure means the process by which the Starting Materials and any intermediate compounds are used to create the Product as communicated by Keryx to BioVectra from time to time, as detailed in the Quality Agreement, and as memorialized in Batch Documentation, including the testing plan.

Examples of Manufacturing Procedure in a sentence

  • Laureate shall have no liability of any nature or kind whatsoever by reason of its performance of its obligations hereunder which arises from as is the result of Laureate's utilization of the [**] Process as a Manufacturing Procedure in connection with the manufacture of CYT-351, CYT-356, Filled ProstaScint Product or Filled Sodium ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇.

  • BioVectra will manufacture Product according to GMPs, Manufacturing Procedure, Specifications and quality requirements set forth in the Quality Agreement as well as in accordance with all Applicable Law (collectively, all the forgoing the “Manufacturing Requirements”).

  • Safety screening will be implemented by BioVectra as part of the Manufacturing Procedure to aid in the identification of foreign particulate matter.

  • This disclosure will permit Vendor to verify that the Application for Marketing Authorization accurately describes the Manufacturing Procedure that Vendor will perform under this Agreement.

  • Any Improvements to the Manufacturing Procedure will be the sole and exclusive property of Keryx.

  • Confidential Information of Keryx includes (i) Manufacturing Procedure, Keryx Supplied Materials, Keryx Technology and Improvements; (ii) development and marketing plans, regulatory and business strategies, financial information, and forecasts of Keryx; (iii) information regarding the Facility design and construction; and (iv) all information of third parties that Keryx has an obligation to keep confidential.

  • Laureate shall have no liability of any nature or kind whatsoever by reason of its performance of its obligations hereunder which arises from, or is the result of, Laureate's utilization of the [**] Process as a Manufacturing Procedure in connection with the manufacture of CYT-351, CYT-356, Filled ProstaScint Product or Filled Sodium Aceta▇▇ ▇▇▇▇▇▇▇.

  • The Parties will enter into separate written change order agreements for any changes to the Manufacturing Procedure or Specifications which impact validation timing and costs.

  • In addition, qualification testing of cladding will be undertaken with chemical, corrosion and mechanical testing performed as outlined in this Manufacturing Procedure Specification and conforming to *** and ***.

  • In all cases, the carbon steel flat samples & pipe that will be clad by CermaClad technology according to this Manufacturing Procedure Specification will undergo mechanical testing prior to cladding in order to ensure that carbon steel base material fully complies with the required mechanical properties in accordance with standard *** and ***.