cGMP Material Sample Clauses
cGMP Material. Chiron will fill the cGMP purified Product lots into containers at the CMF, and store in its V warehouse in accordance with Chiron's approved procedures. Chiron will store the cGMP purified Product for not more than thirty (30) business days from receipt of Chiron's conforming deliverables at EntreMed. Chiron will package filled containers into shipping cartons in accordance with EntreMed's packaging procedures and make the shipping cartons available to EntreMed's designated shipping company. EntreMed accepts all responsibility for the packaged material once its shipping company has accepted it. PROCEDURES, DESIGN AND VALIDATION OF PRODUCT TRANSPORT AND SHIPPING: Depending on EntreMed's specific requirements such as packaging configuration, highest and lowest acceptable shipping temperature, container material and size, fill volume, longest shipping time, etc., Chiron may have appropriately designed shipping cartons and validated packaging and shipping procedures for transferring development and cGMP Product from VMF to Emeryville and for shipping the Product from Chiron to EntreMed or its designated representatives. If Chiron's approved shipping cartons and packaging and shipping procedures are directly applicable for EntreMed's Product, Chiron will use such cartons and procedures. However, if Chiron's approved cartons and procedures are not directly applicable, Chiron will develop and validate cartons and procedures as additional services, if requested by EntreMed, or EntreMed will develop and validate cartons and procedures.
cGMP Material. In the event CELGENE desires SUTRO to manufacture and supply cGMP Development Candidates and their corresponding Licensed Products, for any Development Candidate designated by CELGENE in its sole discretion, in sufficient quantities to permit CELGENE to conduct Clinical Trials and/or commercialize Licensed Products, the Parties shall negotiate in good faith to enter into a separate written agreement regarding such manufacture and supply, including mutually agreed upon quantities, as well as a timeframe for such manufacture and supply consistent with the estimated timeline reasonably proposed by CELGENE, and in accordance with the specifications mutually agreed by the Parties (“Specifications”); provided that SUTRO shall supply such Development Candidate and its corresponding Licensed Products to CELGENE at SUTRO’s Fully Burdened Manufacturing Cost.