Common use of Jazz Responsibilities Clause in Contracts

Jazz Responsibilities. Except as expressly set forth herein, Jazz shall be responsible, at its expense, for all regulatory activities required to obtain and maintain Regulatory Approval for the HemOnc Products, including the preparation of all Regulatory Materials and all communications and interactions with Regulatory Authorities with respect to the HemOnc Products and pharmacovigilance reporting. Jazz shall own all Regulatory Materials (including all INDs, BLAs, XXXx and Regulatory Approvals) for the HemOnc Products. Pfenex shall not submit any Regulatory Materials for the HemOnc Products without the prior written consent of Jazz. Except as expressly requested by Jazz in writing, Pfenex shall not communicate with any Regulatory Authority with respect to the HemOnc Products, unless so required to comply with applicable Laws, in which case Pfenex shall promptly notify Jazz of such requirement under applicable Laws and, to the extent practicable and permitted under applicable Laws, shall submit any proposed communication to Jazz for prior approval or, if not practicable or permitted, shall provide Jazz with a copy or summary thereof as soon as reasonably practicable thereafter.

Jazz Responsibilities. Except as expressly set forth herein, Jazz shall be responsible, at its expense, for all regulatory activities required to obtain and maintain Regulatory Approval for the HemOnc Products, including the preparation of all Regulatory Materials and all communications and interactions with Regulatory Authorities with respect to the HemOnc Products and pharmacovigilance reporting. Jazz shall own all Regulatory Materials (including all INDs, BLAs, XXXx and Regulatory Approvals) for the HemOnc Products. Pfenex shall not submit any Regulatory Materials for the HemOnc Products without the prior written consent of Jazz. Except as expressly requested by Jazz in writing, Pfenex shall not communicate with any Regulatory Authority with respect to the HemOnc Products, unless so required to comply with applicable Laws, in which case Pfenex shall promptly notify Jazz of such requirement under applicable Laws and, to the extent practicable and permitted under applicable Laws, shall submit any proposed communication [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to Jazz for prior approval or, if not practicable or permitted, shall provide Jazz with a copy or summary thereof as soon as reasonably practicable thereafterthe omitted portions.