Master Production Records. 5.5.1 C*P may transcribe the manufacturing information (i.e., formulation, filing work order, packaging work order) into its own format and may obtain written approval from ORPHAN for each document version before manufacturing. However, agreed upon changes to documentation will be handled as outlined by Change Management (see section 10) of this agreement.
Master Production Records. Based on the Client Production Materials, CBSW will prepare Master Production Records for Fresh Product and Cryopreserved Product under the terms and conditions set forth in Section 5.
Master Production Records. 6 5.6 Standard Operating Procedures......................... 6 5.7
Master Production Records. Master Production Records (MPRs) are documents that specify or reference the manufacturing instructions, related bills of material, in process testing, and production specifications used in the production process. These documents are developed and approved by BVL and Customer. Customer’s approval of the MPR must be received at least eight (8) weeks prior to the start of manufacture. Quality Agreement (BVL and Theravance)
Master Production Records. Master Production Records will be developed and approved by CBSB and Tercica. Tercica’s approval of the MPR must be received at least [*] prior to the start of a Run. * This provision is the subject of a Confidential Treatment Request.
Master Production Records. 5.5.1. BAXTER may transcribe the manufacturing information into its own format and will obtain written approval from IDEC for each document version before manufacturing. However, agreed upon changes to documentation will be handled as outlined by Change Management (see section 10).
Master Production Records. LONZA may transcribe the manufacturing information (i.e., bulk manufacturing) into its own fonnat and will obtain written approval from ORPHAN for major changes to the process before manufacturing. Additionally Lonza will provide Orphan with all changes to process documentation, analytical methods, and specifications. Agreed upon changes to documentation will be handled as outlined by Change Management (see Section 10) of this agreement. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX H
Master Production Records. DSM may transcribe the manufacturing information (i.e., formulation, filling work order, packaging work order, etc.) into its own format and shall obtain written approval from Barrier for each document version before manufacturing. Mutually agreed changes to documentation will be handled as outlined by Change Management (see Section 10) of this agreement.
Master Production Records. LONZA may transcribe the manufacturing information (i.e., bulk manufacturing) into its own fonnat and will obtain written approval from ORPHAN for major changes to the process before manufacturing. Additionally Lonza will provide Orphan with all changes to process documentation, analytical methods, and specifications. Agreed upon changes to documentation will be handled as outlined by Change Management (see Section 10) of this agreement.
Master Production Records. Master Production Records will be handled as outlined under Change Management in Section 10 of this Agreement.
