Manufacturing Procedures. Documented manufacturing procedures and special processes shall be available for review by the Purchaser’s quality representative prior to the start of the manufacturing process.
Manufacturing Procedures. In the manufacturing of the vials, RPI shall adhere to the specifications and shall utilize such additional or modified procedures, facilities, equipment and labeling which may from time-to-time be agreed upon in advance and in writing by the Parties and as required by the FDA or other appropriate governmental regulatory authority. Any amendment to the release specifications shall be by agreement of the Parties not to be unreasonably withheld. RPI, at its sole cost, shall maintain and retain samples required by Current Good Manufacturing Practices as defined in 21 CFR 211 et seq. or any other applicable regulations ("GMP"). In addition RPI will, at its sole cost, select and retain samples of each lot of Exogenous Product and conduct an ongoing stability program as mutually agreed to by the Parties, will maintain all stability records for such period as is required by the FDA or other regulatory agency and furnish Schering with copies of all such records at Schering's request and will undertake any lot-by-lot testing required by the FDA or other regulatory agency, or as requested and paid for by Schering pursuant to budgets agreed in advance.
Manufacturing Procedures. If Rosia’s approval of Talecris Inc.’s manufacturing procedures is required under applicable Regulations, Talecris GmbH shall provide Xxxxx with a copy of the ED Dossier/registration that provides a detailed overview of the manufacturing processes that have been implemented by Talecris Inc. Talecris GmbH shall ensure that Talecris Inc. cooperates and provides reasonable assistance to Xxxxx to facilitate Rosia’s compliance with all applicable Regulations, including without limitation, those specified in E.D. directive 91/356, article 12, as may be amended from time to time, and any successor directive thereto. Any change by one Party to the manufacturing procedures that could require a European regulatory submission or affect the available supply of Contractual Products or Finished Products should be communicated in writing to the other Party with copies sent to the following: For Xxxxx: Head of QA/QC Xx. Xxxxxxx Xxxxx +00 0000 000 000 +00 00 0000 0000 (Fax) xxxxxxx.xxxxx.xx@xxxxx-xx.xx Regulatory Affairs Xx. Xxxxxxxxxx Xxxxxxxxxxx +00 0000 000 000 +00 00 0000 0000 (Fax) xxxxxxxxxx.xxxxxxxxxxx.xx@xxxxx-xx.xx For Talecris Gmbh: Head of Quality Assurance Xx. Xxxxxxx Xxxxxxxxx +00 00-000 000-000 +00 00-000 000-000 (Fax) xxxxxxx.xxxxxxxxx@xxxxxxxx.xxx Head of Regulatory Affairs Xx. Xxxxxxxx Xxxxxxxx +00 00-000 000-000 +00 00-000 000-000 (Fax) xxxxxxxx.xxxxxxxx@xxxxxxxx.xxx For Talecris, Inc. Talecris Biotherapeutics, Inc. Attn: Xxxx Xxxxx 0000 XX 00 Xxxx Xxxxxxx XX 00000 Phone: 0-000-000-0000 Email: xxxx.xxxxx@xxxxxxxx.xxx
Manufacturing Procedures. XIANJU warrants and represents that XIANJU has the requisite experience, knowledge and expertise, facilities and qualified personnel, as well as the legal right, to perform its obligations under this Agreement in a sound, safe, lawful and workmanlike manner. Representatives of CLARUS and XIANJU shall meet to develop and approve a Quality Agreement. In the event of conflict between terms of the Quality Agreement and this Agreement, the terms of this Agreement shall govern. The Quality Agreement may be modified from time to time by mutual written agreement. Once executed by both parties, the Quality Agreement shall be incorporated into and made part of this Agreement as [***]. In addition, XIANJU will at all times materially conform with theManufacturing Procedures set forth in [***] attached hereto, which is hereby incorporated herein by reference.
Manufacturing Procedures. Eon warrants that Eon (or any Contract Manufacturer) has the requisite experience, knowledge and expertise, suitable facility and qualified personnel, as well as the legal right, to perform its obligations under this Agreement in a sound, safe, lawful and workmanlike manner. In addition, Eon (or any Contract Manufacturer) will conform with the terms of Appendix 4 attached hereto.
Manufacturing Procedures. .......................................................9
Manufacturing Procedures. 8.01 MDHA AND DHASCO Martek shall manufacture, purify, test, fill, package and store MDHA and DHASCO, as applicable, as summarized in Exhibit A.
Manufacturing Procedures. The Devices will be manufactured and produced using the Quality Agreement Document, Specification Number GNO3-1306 as a nonbinding guideline. Both parties are committed to actively achieving the requirements outlined in this document. Modifications to such document shall require the consent of Supplier, which consent shall not be unreasonably withheld or delayed. Appropriate adjustments to pricing shall be made for any changes which modify Device costs.
Manufacturing Procedures. In the manufacturing of the Vials, Chiron shall adhere to the Beta Specifications and shall utilize such additional or modified procedures, facilities, equipment and labeling which may from time to time be agreed upon in advance and in writing by the Development Committee and/or as required by the FDA or other appropriate governmental regulatory authority. Any amendment to the Release Specifications shall be by agreement of the Parties not to be unreasonably withheld. Chiron, at its sole cost, shall maintain and retain samples required by GMP or any other applicable regulations. In addition, Chiron will, at its sole cost, select and retain samples of each Lot of Betaseron and conduct an ongoing stability program as mutually agreed to by the Parties, will maintain all stability records for such period as is required by the FDA or other regulatory agency * Confidential portions of material have been omitted and filed separately with the Securities and Exchange Commission. and furnish Schering with copies of all such records at Schering's request and will undertake any Lot-by-Lot testing required by the FDA or other regulatory agency, or as requested and paid for by Schering pursuant to budgets agreed in advance.
Manufacturing Procedures. The Manufacturing Procedures shall be reviewed and approved, in writing, by Biovest and by AYTU prior to commencement of Manufacture. Any material change to approved Manufacturing Procedures will be reviewed and approved by Biovest and by AYTU prior to said change being implemented. Any deviation from the manufacturing process specified in the Manufacturing Procedures must be documented in the copy of the Manufacturing Procedures for that Batch. Biovest shall provide AYTU with required supporting Manufacture documentation in a form reasonably suitable for AYTU’s submission to the FDA, as requested by AYTU. The foregoing notwithstanding, Biovest has no obligation to disclose to AYTU any Biovest manufacturing know how related to Biovest proprietary cell culture media and nutrient feeds used in Manufacturing.
