Estimated Timeline. At-scale validation is anticipated to start in December 2012 FACTOR IX APPENDIX B TIMING See attached timeline Assumptions to Attached Timeline • Adherence to timeline and deliverables will be managed per the terms outlined in the Commercial Supply Agreement (CSA) • CMC will provide a weekly timeline update to Inspiration. This will include an update for the tasks for percent completion, actual start dates and actual/target dates for completion • The timeline for activities supporting at-scale validation, including bench scale model qualification, bench scale characterization, viral clearance, resin lifetime validation, and stability validation will need finalization. This work will need to be prioritized against other deliverables associated with the MAA and BLA filings. CMC and Inspiration will prioritize and finalize the timing for these activities after signature of this amendment. The target date for completing the prioritization is 14 days after signature of the amendment • The attached timeline assumes that the Validation campaign will occur in Line A and occur in manufacturing slots already reserved by Inspiration. Inspiration has requested evaluation of an option for two Inspiration manufacturing batches scheduled in Line B in the December 2012 to January 2013 timeframe be eliminated so as to execute batches only in Line A. This would provide the ability to compress the timing for the Process Validation/manufacturing batches in Line A and thus enables a more timely completion of the Process Validation batches and subsequent reports. Such a change would have financial considerations as well as implications for the Line B validation and approval plans. These implications and considerations are not subject of this amendment and will need to be resolved per the terms of the relevant amendments and the CSA. The timeline compression options will be evaluated and agreed to by both parties after signature of this amendment. The target date for completing this agreement is 14 days after signature of the amendment • The attached timeline for Validation is based on the process knowledge known to-date. Delays (due to contract negotiations, delay in the re-start of the HCP reduction work, technical challenges, or change in plans for the process to be implemented) will impact the proposed timeline FACTOR IX APPENDIX C PRICE AND PAYMENT TERMS Stage Services Price and Payment Terms for Stage [**] Stage 1 Bench scale development, optimization and characterization ...
Estimated Timeline. Time Frame Iteration projected start dates: – Staffing the positions may result in a 90-120 day delay in starting the project.
Estimated Timeline. The Customer’s project will be scheduled with the appropriate project manager and engineering resources upon contract signing. TNL has provided Customer an estimated project timeline included as Exhibit F. Timeline dates may vary depending on Customer configuration and customization requirements and are subject to change based on requirements gathered from the Project Kick-off and discovery phase. TNL project manager will provide Customer a complete project timeline upon completion of the Project Charter.
Estimated Timeline. As discussed in the conference call on September 11, 2008, this process should begin upon the execution of the signed agreement. As a result of the upcoming elections, we recommend this phase start and be completed within two weeks after contract approval. A notional timeline and project plan is attached. Phase Two – Business Rule Development & SouthTech Application Integration These tasks are primarily offsite task. Objectives: ● SouthTech integration with Extract to create new GUI user interface screens ● Create an import program for indexing and redaction - develop business rules ● County to identify data elements to be indexed ● Development process (estimated duration: 35 days) Deliverables at the Conclusion of this Phase: ● Completed import of images history ● Completed guidelines document ● Approved business rules development ● County has received hardware, and installed with operating system on network Estimated Timeline: Phase Two will be approximately 5 weeks long. During this phase, the primary task to be completed is the rule writing process, and will require minimal involvement from the County as they prepare for the upcoming elections.
Estimated Timeline. Timeline Description Week 1 • Kick Off Call • Discovery & Requirements Gathering Weeks 2-4 • Assessor and permit data received • Address Identification Process Kicks Off Weeks 5-16 -Conduct staff training on EngagementHQ -Launch EngagementHQ -Commence public engagement and outreach process -Interview key staff and policy makers -Produce background conditions report -Draft STVR regulations Weeks 17-20 - Create framework for mobile permitting and tax collections - Finalize Compliance Monitoring letters - Establish lettering criteria - Midway satisfaction survey sent Weeks 21-23 • Finalize Mobile Permitting and Tax Collection work • UAT Testing with Project Champion • Stakeholder Training • 24/7 Hotline Created Weeks 24-26 (GO Live & Hypercare) • Go live satisfaction survey sent • Introduction of your Customer Success Consultant • Ongoing management plan established • Rental Activity Monitoring module turned on
Estimated Timeline. The provisional timeline for the Project is structured as follows: Week # Description 3 EIU submits interviewee list and story board for Video 7 Second draft review of Video
Estimated Timeline. Milestone Milestone Payment End of Sept. 04 Signing of Head of Terms [***] (already achieved) June 30, 2004 Filing by CoTherix of NDA for Ventavis (with Ventavis being delivered through the Prodose Device) [***] (already achieved) Aug./Sept. 04 [***] for supply to CoTherix by Profile of at least three (3) I-Nebs for testing, and [***] upon completion of in vitro testing evidencing to the reasonable satisfaction of CoTherix that the 2.5 and 5 ug doses delivered by the I-Neb match those delivered by the Prodose Device - i.e., successful bridging [***] ([***] has been earned to date) Oct.-Dec. 04 Filing by Profile of 510(k) application for I-Neb [***] if filing accepted by the FDA for review in Oct. 04 or Nov. 04; [***] if filed in Dec. 04; [***] if filed in Jan. 05 or thereafter (already achieved) Nov.-Dec. 04 Signing of this Agreement [***] [***] FDA Approval for Ventavis using the Prodose Device as the delivery method [***] [***] Submission by CoTherix of NDA Supplement for Ventavis using the I-Neb as the delivery method [***] [***] Receipt of 510(k) clearance by FDA for the I-Neb [***] if received in Apr. 05; [***] if received in May 05; [***] if received in June 05; [***] if received in July 05; [***] if received in Aug. 05 * CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION Estimated Timeline Milestone Milestone Payment [***] Approval by FDA of NDA Supplement for Ventavis using the I-Neb as the delivery method and production and Profile Quality Control release of at least 500 I-Nebs (as proof that production is established and reliable) [***] All Milestone Payments will be invoiced by Profile upon achievement of the applicable milestone and are due and payable within 30 days of the date of the invoice. The Estimated Timeline (column on left above) is an estimate only and Milestone Payments are payable to Profile when they are achieved even if they are achieved after the dates set forth in the Estimated Timeline, provided that in any case in which specific dates are set forth in the right hand column above entitled “Milestone Payment,” the amount of the Milestone Payment shall be governed by the date on which the milestone is achieved. For purposes of clarification, the [***] in Milestone Payments indicated in the “Milestone Payment” column as already having been earned, were invoiced to CoTherix on September 30, 2004 and paid by CoTherix on November 12, 2004. The [***] Milestone Payment due to Profile for the filing of the 510(k) a...
Estimated Timeline. Exhibit G (Construction Timeline) is attached hereto and sets forth the estimated schedule for construction events and the projected dates for the access and expansion dates described above. Such timeline represents the parties current expectations and the parties shall use commercially reasonable efforts to adhere to such projected timeline; provided however (i) in the event of any conflict between the dates in Exhibit G and the time periods required by the body of the Lease, the body of the Lease shall control, and (ii) in no event shall Tenant to entitled to any remedies in the event any of the dates in the projected timeline are not met, unless and to the extent specifically set forth in Section 12 below.
Estimated Timeline. The estimated time to complete the services described in the Proposal is [insert length of time].
Estimated Timeline. The parties anticipate that the Product will be ready to market by the summer of 2007 and will use commercially reasonable efforts to stay within this timeline.
