Communications/List of Contact Persons. Any and all communication shall take place by and through the contact persons named by the Parties. The current list of contact persons is attached hereto as Appendix 1 and shall be updated as necessary via amendment to this Agreement. Appendix 1: List of Contact Persons Appendix 2: Authorization for Shipment under Quarantine Appendix 3: Manufacturer’s Release Specifications Appendix 4: List of Critical Raw Materials Appendix 5: Change Permit Form Date / Signature Date / Signature Date / Signature (Xx. Xxxx Xxxxxxxxxxxx, VP Legal Germany) Date / Signature (Xx. Xxxx Xxxxxxxxxx, VP Quality & Compliance) • Scale-up / GMP-Manufacturing [***] Name e-mail: Tel.: • Analytics QC [***] Name e-mail: Tel.: • Batch Release Local QP [***] Name e-mail: Tel.: • Quality Assurance QA [***] Name e-mail: Tel.: Manufacturing stage: Drug Substance ¨ Drug Product ¨ Batch no: Quantity: Order no: Estimated release date: CLIENT herewith confirms that the above mentioned material will not be used in humans until it has been fully released by BOEHRINGER INGELHEIM and CLIENT Quality Operations. Test methods and acceptance criteria for [fill in name] Drug Product for manufacturer’s release Test methods and acceptance criteria for [fill in name] Drug Substance for manufacturer’s release 1 2 4 5 6 7 8 9 10 11 12 13 14 Organization Requesting the Change: ¨ BOEHRINGER INGELHEIM ¨ CLIENT Name & Title of Requesting Individual: Date of Submission: Product / Material: ¨ [fill in name] ¨ Raw Material ¨ Other: Description of Proposed Change: ¨ Process / Material Change with Document Impact ¨ Document Change(s) only ¨ New Document(s) ¨ Other: Impacted Document(s): Document Number ____________________________ / ____________________________ / ____________________________ / Title ____________________________ ____________________________ ____________________________ Revision (From / To) Reason for Change and Supporting Documentation: ¨ Environmental, Health & Safety ¨ Quality Improvement ¨ Adjustment to requirements of pharmacopoeia ¨ Cost Savings ¨ Other: Attachments: ¨ Final Draft ¨ List of Changes ¨ Other: ¨ Major ¨ Minor ¨ None QA Approval of proposed Changes: Herewith CLIENT agrees with the aforementioned Change(s) and the implementation at BOEHRINGER INGELHEIM ____________________________________________ (Signature of QA Representative and Date) Ø Return signed Change Permit Form to BOEHRINGER INGELHEIM QA
