Helix Sample Clauses

Helix. CPL may be asked to perform limited physical testing *** n/a Primary – Helix Secondary – CPL Primary testing will be performed by Helix. CPL may be asked to perform limited physical testing. *** n/a To Be Determined Component Test Responsibility Notes *** n/a CPL – COA & Spec *** n/a CPL – COA & Spec Schedule C – Estimated Timelines Activity (Task) Start Completion Initial Kick-Off Team Meeting and Process Design Discussions *** *** Tank Drawing and Specification *** *** Tank Drawing Review, Comment and Revise *** *** Tank Drawings Approved *** *** Tank Fabrication Process *** *** Tank Delivery To CPL *** *** Uncrate and Install *** *** IQOQPQ and DOE Placebo Batch *** *** 1st Placebo Manufacturing Batch and Analytical Testing *** *** 1st Placebo Packaging Operation and Analytical Testing *** *** 1st Active Manufacturing Batch and Analytical Testing *** *** 1st Active Packaging Operation and Analytical Testing *** *** Stability Starts – Ends *** *** The above is a partial list of activities (critical path) that illustrate a tentative timeline. There are additional pieces of equipment that would be required to support this timeline and activities. The associated lead times of other equipment is assumed to be less than the main mix tank. A full timeline will be established as the project progresses. This list of additional equipment includes but is not limited to: - Microfluidizer and associated installation and qualification tasks. - Filler change parts and drum emptying system and associated installation and qualification tasks up to and including packaging line trials.
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Helix. Helix shall be solely responsible for (i) all expenses incurred by Helix in connection with its provision of the Management Services hereunder and (ii) any expenses incurred by DermaVentures which are solely attributable to its relationship with Helix hereunder in an aggregate amount in any given fiscal year in excess of $25,000, including, with respect to clause (ii) above, any incremental expenses for legal or audit/accounting services in excess of $7,500 each in any given fiscal year. To the extent Helix incurs any other expenses on behalf of DermaVentures, Helix shall submit a claim for reimbursement thereof to DermaVentures and DermaVentures shall promptly reimburse such amount, provided such expenses have been approved in advance by the Executive Manager.
Sample 1

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