Scale Up i. End User may request to scale up the Performance Level or add new environments during the Subscription Term by contacting the Bizagi Authorized Reseller. Such Bizagi Authorized Reseller will coordinate with Bizagi to comply with such request. End User will be required to pay any fees to the Bizagi Authorized Reseller resulting from such scale up in Performance Level in accordance with the payment terms of its agreement with the Bizagi Authorized Reseller.
Scale Up. In the event that Phytera engages in scale up manufacturing of VHEs or OVLSs pursuant to Section 3.5, Chiron shall reimburse Phytera for its fairly allocated costs associated with such scale up manufacturing.
Scale Up. Following the successful technology transfer, upon request by Bioamber and subject to Cargill’s availability of appropriate resources, Cargill will enter at its sole discretion into a services agreement with Bioamber to assist in the fermentation scale-up of using Modified CB1 obtained under Milestones 2 and 3 for producing succinic acid and salts thereof at a single Bioamber facility or a facility designated by Bioamber. Cargill shall invoice Bioamber [***] U.S. Dollars (US$[***]) per man-day provided, not inclusive of taxes or other governmental fees, and further adjusted for inflation at the time it goes into effect. Cargill shall have no obligation to perform scale-up work at Cargill facilities.
Scale Up. CLU up and running, pressure testing of “killer issues” completed.
Scale Up. Following the successful technology transfer, upon request by Bioamber and subject to [***]. Cargill shall invoice Bioamber [***] U.S. Dollars (US$[***]) per man-day provided, not inclusive of taxes or other governmental fees, and further adjusted for inflation at the time it goes into effect. Cargill shall [***].
Scale Up i. End User may request to scale up the Performance Level for any of its Environments during the Subscription Term by contacting the Bizagi Authorized Reseller. Such Bizagi Authorized Reseller will coordinate with Xxxxxx to comply with such request. End User will be required to pay any fees to the Bizagi Authorized Reseller resulting from such scale up in Performance Level in accordance with the payment terms of its agreement with the Bizagi Authorized Reseller.
ii. Automatic Scale Up / BPU Report. Bizagi will generate a BPU usage report on a monthly basis which shows End User’s BPU consumption during the previous month (“BPU Report”). If the BPU Report shows that End User has exceeded the maximum number of BPU’s included in the contracted Performance Level as permitted in its subscription for two consecutive months and End User fails to upgrade to the appropriate Performance Level during such two (2) month period, then Bizagi will notify the Bizagi Authorized Reseller and automatically scale up End User to the appropriate Performance Level. The appropriate Performance Level will be determined based on the average BPU usage during the previous two (2) month period. End User will be required to pay any fees to the Bizagi Authorized Reseller resulting from such scale up.
Scale Up lf Forty Seven is able to secure a minimum of [*] scale manufacturing cGMP Batch with Lonza (subject to availability) through contractually binding commitment then Lonza will release Forty Seven for [*] and the [*]; provided that a notice for such change must be given by Forty Seven at least [*].
Scale Up. SDI hereby covenants that it shall scale up to commercial scale the processes (including API manufacture, Finished Product manufacture, and all associated QA/QC and analytical methods) for each the IR Product and the CR-Qualified Product. SDI shall finish doing so for each Licensed Product prior to Avigen commencing any Pivotal Clinical Trial(s) of such Licensed Product that Avigen may undertake. Currently (as of the Commencement Date), Pivotal Clinical Trials of an IR Product are expected to commence no earlier than [*] However, these dates are not binding. Avigen will keep SDI updated as to Avigen’s clinical plans for Licensed Products through Committee meetings under Section 5.1 of the License Agreement.
Scale Up. Client may increase the number of inVentiv Account Managers and RBD above the number outlined in Exhibit A (a “Scale Up”) upon written notification to inVentiv. In the event of a Scale Up, Client shall pay to inVentiv an additional Implementation Fee and Fixed Monthly Fee as follows: Per Account Manager [ * ] Per RBD [ * ] Per Account Manager [ * ] [ * ] Per RBD [ * ] [ * ]
Scale Up. Section 2.1 Scale-Up for Supply of Licensed Product
a. Scale-Up Process. SciClone will purchase from RESprotect the Licensed Product which it requires for the manufacture of Licensed Finished Product prior to and after FDA approval of Licensed Finished Product. RESprotect has subcontracted with, among others, [****] to manufacture the Licensed Product. SciClone and RESprotect acknowledge that the manufacture of the Licensed Product by RESprotect will require a scale-up period of approximately [****] and the expenditure of considerable funds. SciClone and RESprotect agree to share [****] when such scale-up costs are incurred. The expected scale-up costs are set forth in Appendix 1. RESprotect agrees to provide SciClone with specific manufacturing information and documents including certificates of analyses, batch records and all other documents as required for FDA filings, within thirty (30) days following a request for such specific manufacturing information by SciClone, unless RESprotect is prevented from such provision by reason of a conflicting existing provision with a contract manufacturer of RESprotect. The details of the scale-up will be set forth in a plan (“Scale-Up Plan”) which shall be determined by good faith agreement between RESprotect and SciClone. RESprotect and SciClone agree to cooperate in good faith to obtain detailed information regarding the manufacturing process and scale-up efforts by Third Party contractors of RESprotect.
