Genentech Obligations. Except with respect to obligations of Immunex --------------------- under Section 3.4(b) above, Genentech shall use Commercially Reasonable -------------- Best Efforts to timely prepare and obtain, and Commercially Reasonable Efforts to maintain, all regulatory approvals that are required to manufacture Bulk Drug at the Genentech Facility in South San Francisco, California, including, without limitation, the preparation, filing and maintenance of supplements to Genentech's existing FDA licenses (and drug master file), and Genentech shall reasonably assist Immunex in meeting its obligations under this Section 3.4, including, without ----------- limitation, reasonably assisting with the preparation and review of the drafts of the chemistry, manufacturing and controls sections of the sBLA to be filed by Immunex with FDA. Genentech shall also reasonably assist Immunex in responding to requests and inquiries from the FDA prior to, during and after regulatory review periods and by attending meetings with such regulatory authorities to the extent it is essential for Genentech to participate given its unique * Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. The omitted portions of this exhibit have been filed separately with the SEC. knowledge or its status as manufacturer of Bulk Drug under this Agreement. Genentech personnel shall also facilitate pre-approval inspection of the Genentech Facility conducted by such regulatory authorities. The assistance to be provided by Genentech under this Section 3.4(c) shall be provided at no additional cost to Immunex, -------------- except as otherwise provided in Sections 3.9 and 4.5 hereof. --------------------
Genentech Obligations. In the event that XOMA cannot find a Third Party to manufacture that is acceptable to Genentech, and to the extent the manufacture of Licensed Product for XOMA will not unreasonably, and adversely impact Genentech or its obligations to Third Parties or Affiliates, then Genentech will continue to supply Licensed Product in bulk form only until the earlier of (i) [*] from XOMA's receipt of notice of Genentech's election not to produce or supply or (ii) [*] from the date on which Genentech and XOMA find a mutually acceptable manufacturer. In the event Genentech does approve of a Third Party to manufacture Licensed Product, and to the extent the manufacture of bulk Licensed Product for XOMA will not materially and unreasonably adversely impact Genentech or its obligations to Third Parties or Affiliates, Genentech shall, at XOMA's request, continue to manufacture Licensed Product in bulk form for up to [*] after Genentech and XOMA approve a Third Party manufacturer. Notwithstanding anything to the contrary, at a minimum, Genentech must supply XOMA with the amount of Licensed Product in bulk form which is yielded from one successful [*] Run each year that Genentech is obligated to supply Licensed Product hereunder.
Genentech Obligations
