Common use of Regulatory Inspection Clause in Contracts

Regulatory Inspection. (i) Pfenex shall promptly (and in any event within one (1) Business Day of becoming aware thereof) notify Jazz of any Regulatory Authority inspections relating to any HemOnc Product or related activities under the applicable Development Plan. Jazz shall have the right to be present at any such inspections and shall have the opportunity to provide, review and comment on any responses that may be required. Pfenex shall provide Jazz with copies of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection. In addition to such obligations with respect to Regulatory Authority inspections, Pfenex shall promptly (and in any event within one (1) Business Day following receipt thereof) notify Jazz of any information it receives regarding any threatened or pending action or communication by or from any Third Party, including a Regulatory Authority, that may materially affect the Development, manufacturing, Commercialization or regulatory status of HemOnc Products.

Regulatory Inspection. (i) Pfenex shall promptly (and in any event within one (1) Business Day of becoming aware thereof) notify Jazz of any Regulatory Authority inspections relating to any HemOnc Product or related activities under the applicable Development Plan. Jazz shall have the right to be present at any such inspections and shall have the opportunity to provide, review and comment on any responses that may be required. Pfenex shall provide Jazz with copies of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection. In addition to such obligations with respect to Regulatory Authority inspections, Pfenex shall promptly (and in any event within one (1) Business Day following receipt thereof) notify Jazz of any information it receives regarding any threatened or pending action or communication by or from any Third Party, including a Regulatory Authority, that may materially affect the Development, manufacturing, Commercialization or regulatory status of HemOnc Products. [***] 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 the omitted portions.