definiens: means, subject to Section 5.7, with respect to a single Qualification Run or Commercial Run, or a single Batch or Lot produced from such a single Qualification Run or Commercial Run, conformance of that Run to all elements of : ( i ) the quality requirements of this Agreement, the Technology Transfer Project Plan and the Quality Agreement ; ( ii ) the Product Specifications as they exist at the time of the inoculation [ of the one hundred liter ( 100L ) ] bioreactor for such Batch ( or such earlier time as may be appropriate in the event that there are any modifications to those portions of the Manufacturing Process occurring prior to the inoculation [ of the one hundred liter ( 100L ) ] bioreactor or which require changes to the materials used ( or specifications therefor ) prior to the inoculation [ of the one hundred liter ( 100L ) ] bioreactor ) ; and ( iii ) all applicable United States laws and regulations