Production Issue definition

Production Issue is an interruption or stoppage of any of Applied's manufacturing operations in the United States of America (as, or equivalent to, a "line down" situation) that results from a failure of an Item to conform to warranty, from other defect in or damage to an Item delivered by Supplier, a failure or interruption in the timely delivery of Items by Supplier on Committed Delivery Dates, or from other failure in Supplier's performance under this Agreement. Applied shall notify Supplier of a Production Issue by telephone, cell-phone or pager to the following persons:
Production Issue means (a) the inability of the SUTRO expression system to achieve [*]; (b) [*] a Collaboration BAC, or corresponding Development Candidate or Licensed Product, through the SUTRO expression system [*]; (c) the FDA or other Regulatory Authority does not permit conduct of Clinical Trials using, or does not grant Regulatory Approval for, a Collaboration BAC, or corresponding Development Candidate or Licensed Product, due to CMC reasons attributable to SUTRO’s expression system; and (d) the manufacturing of a Collaboration BAC, or corresponding Development Candidate or Licensed Product, using SUTRO’s expression system is subject to material third party intellectual property infringement claims; [*].

Examples of Production Issue in a sentence

  • If Supplier is required to provide labor at Applied facilities to meet repair times for Production Issue Items, the labor cost will not exceed *.

  • Unless a Production Issue has occurred, CELGENE shall not be entitled to set off applicable milestone payments to SUTRO pursuant to this Section 7.4.5 by amounts (if any) attributable to CELGENE Manufacturing Costs for parallel cell-based development pursuant to Section 6.5.1.

  • Crafter Enterprise Gold Support Crafter Enterprise Platinum Support Hours of Coverage Standard Business Hours 7x24 for Severity 1 issues; Standard Business Hours for all other issues Support Channel Web Web Number of Cases Unlimited Unlimited Technical Support Contacts 2 3 Severity 1: A Severity One Production Issue means the (i) production system is severely impacted or completely shut down, or (ii) system operations or mission-critical applications are down.

  • In addition, the JSC shall meet at a mutually agreeable place and time within ten (10) Business Days following SUTRO’s receipt of CELGENE’s notice of a Production Issue, or as otherwise appropriate to discuss the matters described in Section 5.2.4(i).

  • Delivery of Production Issue Data–Prior to an initial live date of Positive Pay processing, Company shall upload a minimum of sixty (60) days’ worth of issued items into the Positive Pay Service.

  • In the event of a Production Issue for a particular BAC/ADC Program, CELGENE will notify SUTRO thereof in writing and upon SUTRO’s request the Production Issue will be discussed at the JSC.

  • If the failure constitutes or results in a Production Issue under Section 2.4, Supplier shall comply with that Section of this Agreement.

  • If Supplier is required to provide labor at Applied facilities to meet repair times for Production Issue Items, the labor cost will not exceed ***.

Related to Production Issue

  • Production means a method of obtaining goods including manufacturing, assembling, processing, raising, growing, breeding, mining, extracting, harvesting, fishing, trapping, gathering, collecting, hunting and capturing.

  • Postproduction means an activity related to the finishing or duplication of a medium described in Subsection 59-12-104(54)(a).

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Commercial Production means the operation of the Property or any portion thereof as a producing mine and the production of mineral products therefrom (excluding bulk sampling, pilot plant or test operations);

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.