Production at Development Scale. Prior to the establishment of Commercial Scale per section 4.2(a), as quickly as reasonably practicable, but no later than [*], XOMA will initiate [*] cGMP Batches of Drug Substance at the [*] liter Development Scale in calendar [*], and ONYX will receive all of each such Batch for purposes of (i) satisfying ONYX and Pfizer's projected needs for a working stock of active ONYX-015 virus and for ONYX-015 supplies for critical clinical trials, (ii) generating experimental data to support proposed process changes, (iii) supporting the preparation and filing of appropriate documentation (e.g. a Drug master file or any new or amended INDs for ONYX-015 that ONYX or an ONYX Partner may file), and/or (iv) supporting any BLA that ONYX or Pfizer may file for ONYX-015. The Parties will consult as to ONYX's additional needs for Development Scale Batches, based on its needs for the purposes set forth in this Section 4.3, and XOMA will consider in good faith any requests by ONYX for such additional production of Drug Substance at Development Scale, with any production to be included in the Work Plan only upon the Parties' mutual agreement. If XOMA produces any additional Development Scale Batch pursuant to this Section 4.3, then: (i) the Parties will agree upon an extension of the timeframes in Section 11.3(a) pursuant to which ONYX may terminate this Agreement without penalty; and/or (ii) the Parties will agree upon an extension of the period during which XOMA will manufacture the guaranteed minimum number of Batches so as to permit XOMA to recapture its economic benefits as contemplated in this Agreement. In addition, as soon as practical but not later than [*], XOMA shall produce [*] cell suspension-adapted HEK 293 cell banks (to include [*]) in full compliance with cGMP and produced in Xoma's cGMP cell banking facility. Each bank must contain at least [*] vials (net of vials removed for QC testing and retains), and must meet Onyx specifications for suspension-adapted HEK 293 master or working cell banks ("Cell Bank Specifications"), as appropriate. Additionally, Xoma shall use reasonable efforts to produce [*] additional cell suspension-adapted HEK 293 cell banks, also to include [*], in full compliance with cGMP and produced in Xoma's cGMP cell banking facility. Each bank must also contain at least [*] vials (net of vials removed for QC testing and retains), and must meet Onyx specifications, as appropriate. Copies of the current cell bank specifications are attache...
