MRR Documentation definition

MRR Documentation means all production and release documentation specified in the Manufacturing and Release Requirements, as described in Exhibit A.
View Source
MRR Documentation means all production and release documentation as described in Exhibit "A".
View Source

Examples of MRR Documentation in a sentence

  • COPHARMA shall provide SERAGEN copies of all MRR Documentation relating to the services provided and PRODUCT supplied under this Agreement.

  • COPHARMA shall provide SERAGEN'S quality assurance and compliance department with copies of completed MRR Documentation listed in Exhibit A, and shall endeavor to do so within 10 business days of COPHARMA QA release of PRODUCT.

  • Within thirty (30) days after COPHARMA QA release of each batch of PRODUCT and receipt of all MRR Documentation, SERAGEN shall determine by review of the MRR Documentation whether or not the given Batch of PRODUCT conforms to the Manufacturing and Release Requirements, and was manufactured in accordance with cGMPs; provided that COPHARMA provides timely answers to information requests and resolution of issues arising from SERAGEN's review of MRR Documentation.

  • Within thirty (30) days after SERAGEN's receipt of all MRR Documentation, SERAGEN shall determine by review of the MRR Documentation whether or not, in SERAGEN's sole opinion, the given Batch of Fermentation Pellets, First Gen PDS and/or Second Gen PDS conforms to the Manufacturing and Release Requirements, and was manufactured in accordance with cGMP; provided that CBSH provides timely answers to information requests and resolution of issues arising from SERAGEN's review of MRR Documentation.

  • COPHARMA shall bear such expenses of the cGMP organization if the findings confirm the non-conformity, and SERAGEN shall bear such expenses if the findings confirm that the PRODUCT was manufactured in accordance with cGMPs and/or required MRR Documentation.

  • Pending acceptance or rejection of Lot(s) by SERAGEN, SERAGEN may comment upon or request changes to the HOLLISTER-STIER MRR Documentation and HOLLISTER-STIER shall either ▇) ▇▇▇▇▇▇▇ ▇▇ such comments/requests ▇▇ ▇) ▇▇▇▇▇▇▇ ▇mended HOLLISTER-STIER MRR Documentation to SERAGEN within 10 business da▇▇ ▇▇ ▇▇▇ ▇▇▇▇▇pt of SERAGEN's comments/requests.

  • All such MRR Documentation shall be provided within 10 business days of CBSH QA Release.

  • All such MRR Documentation shall be provided in a timely manner at the request of SERAGEN.

  • In the event that the Parties cannot resolve a dispute regarding conformance with cGMPs and/or required MRR Documentation, the Parties shall submit the issue to a mutually agreed upon expert cGMP organization.

  • In the event that the Parties cannot resolve a dispute regarding (i) the cause of a Batch's non-conformance with Fermentation Pellet, First Gen PDS and/or Second Gen PDS Specifications and/or failure to meet the Manufacturing and Release Requirements, (ii) conformance of a Batch with cGMP, or (iii) conformance of a Batch with the required MRR Documentation, the Parties shall submit the issue to a mutually agreed upon arbitrator.

Related to MRR Documentation

  • User Documentation means that documentation regarding the operation, guidelines and features and functionality of Clover Insights that is made available to you from time to time at the website, by internet link or otherwise. User Documentation may be modified from time to time by First Data or its third party provider(s).

  • Related Documentation means, with respect to Software, all materials, documentation (including control documentation utilized in connection with an audit), specifications, technical manuals, user manuals, flow diagrams, file descriptions and other written information that describes the function and use of such Software, but excluding source code.

  • DMA Customer Documentation means the agreements (together with any applicable schedules, exhibits or appendices thereto required by BSEF) in form and substance acceptable to BSEF, that are required to be executed and delivered to BSEF before a DMA Customer may access the SEF Platform. Except as otherwise provided in these Rules, in the event of any conflict between these Rules and the DMA Customer Documentation, these Rules shall govern.

  • Account Documentation means any and all Account information, credit applications, Cardholder Agreements and change in terms notices, Charge Transaction Data, charge slips, credit slips, payments, credit information and documents or forms of any type and in any media relating to the Program, excluding materials used for advertising or solicitations.

  • Supporting Documentation means the documents listed in Schedule A of this Certificate which forms part of this