Development Run definition

Development Run means a Run used for process demonstration and --------------- confirmation of some or all of the Manufacturing Process steps, and is described in Section 3.7(a) hereof. --------------
Development Run means a Run used for process demonstration and

Examples of Development Run in a sentence

  • If Wyeth is unable to achieve [*] Completed Development Runs [*] Development Run Starts, Genentech shall either (i) terminate the Transaction Agreements in accordance with Section 21.5.1 or (ii) authorize Wyeth to commence up to [*] additional Development Runs Starts [*] Completed Development Runs.

  • During the Technology Transfer, Wyeth shall use its Commercially Reasonable Diligent Efforts to conduct Development Runs at such size and in such quantity (subject to the remaining provisions of this Section 4.7) sufficient to produce [*] Completed Development Runs as set forth in the Technology Transfer Project Plan and to achieve Development Run Completion as quickly as possible using as few Development Run Starts as possible.

  • For each Development Run Start (up to a maximum of [*] Development Run Starts), Genentech shall pay Wyeth a Conversion Fee equal to [*] Wyeth shall invoice Genentech for the Conversion Fee of each Development Run Start following the Run Start for that Development Run.

  • The Parties agree and acknowledge that the [*] Development Run Starts initiated by Wyeth may conclude with the fermentation phase of the Manufacturing Process ("Fermentation Run Starts"), [*] Wyeth shall manufacture such Development Runs [*].

  • Upon completion of each Development Run, Wyeth shall deliver to Genentech the complete documentation for such Run as required by the Technology Transfer Project Plan.

  • If Development Run Initiation is achieved by [*], Genentech shall pay Lonza [*].

  • It is understood that if Lonza commences a Development Run, and delivers 3 Successful Development Runs prior to finishing such commenced Development Run, Genentech will pay for such commenced Development Run (subject to not having to pay for more than four (4) Development Runs).

  • With respect to each Development Run, Wyeth shall perform in-process, comparability and release testing and analysis, as required by and in accordance with the Quality Agreement.

  • Genentech shall notify Wyeth, in writing, of its election within ten (10) business days after Genentech's receipt from Wyeth of an investigation report regarding the root cause(s) of the Development Run failures.

  • If Wyeth elects to commence additional Development Run Starts as provided above and still fails to achieve [*] Completed Development Runs [*] Development Run Starts as applicable based on Wyeth's election, either Genentech or Wyeth shall have the right to terminate the Transaction Agreements in accordance with Section 21.5.

Related to Development Run