GMP Manufacture Sample Clauses

GMP Manufacture a) Xx. Xxxxx’x will manufacture, using the process developed and optimized in Sub-Projects 1 and 1B and scaled-up in Sub-Project 2A, 40 kg of GMP PBT2 drug substance according to the applicable regulatory and statutory requirements of current Good Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 and ICH Q7).

GMP Manufacture. ROCHE will provide GMP manufactured HPV Reagent Products (termed “Notebook ”, “Draft Production” and “Production” lots) made to the agreed upon specifications and batch sizes, using the process description as provided by ROCHE and approved by GPRO. (Notebook lots may not include all required GMP documentation.) During Notebook Lot manufacturing, it is expected that ROCHE will concurrently develop GMP compliant systems and processes for the manufacturing of Production Lot oligonucleotides. GPRO may initiate ordering of Draft Production or Production Lot materials prior to the conclusion of Notebook Lot production. Subject to Section 4.2 of the Agreement, GPRO will allow a maximum of 120 calendar days from the time of order placement to receipt of Draft Production or Production Lot material. If and to the extent that GPRO specifies or provides to ROCHE any method for oligonucleotide synthesis and/or oligonucleotide purification processes, GPRO shall provide to ROCHE any existing validation or verification of such methods. If and to the extent that ROCHE uses ROCHE’s methods for oligonucleotide synthesis and/or oligonucleotide purification processes, ROCHE will provide a validation or verification plan for the oligonucleotide synthesis and oligonucleotide purification processes before initiating the manufacture of the first Notebook lot. These ROCHE validation and/or verification plans must be agreed upon by GPRO and ROCHE. HPV Reagent Products manufactured by ROCHE shall be delivered in accordance with the terms and conditions of the Agreement and, unless GPRO requests deferral of delivery pursuant to Section 4.4 of the Agreement, shall be delivered no more than four (4) months following the date of manufacture.

GMP Manufacture. ACT will manufacture, or have manufactured, the chosen ******* material under GMP conditions for clinical development use and monitor the stability of such ******* material over the duration of the clinical program, but not to exceed two years for any given lot. The completion of the GMP manufacture of ************************************** ****************************** shall be *************************************** ********************** after BioTransplant's notification of the chosen ******* material. If additional material is required by BioTransplant, such material must be produced pursuant to Section 4.3.3. Information for regulatory use is covered by Section 7.5.