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. (ii) Jazz shall promptly (and in any event within one (1) Business Day of becoming aware thereof) notify Pfenex of any Regulatory Authority inspections relating specifically to the manufacturing process developed by Pfenex for any HemOnc Product (or any modified version of such manufacturing process for such HemOnc Product) and conducted by Jazz, its Affiliate or any Third Party manufacturer. Jazz shall provide Pfenex with copies of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection to which it has access and authority to disclose; provided that Jazz shall only provide Pfenex with any such materials received by a Third Party to the extent permitted under Jazz’s agreement with such Third Party. In addition to such obligations with respect to Regulatory Authority inspections, Jazz shall promptly (and in any event within one (1) Business Day following receipt thereof) notify Pfenex 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 manufacturing or regulatory status of HemOnc Products; provided that Jazz shall only provide Pfenex with any such information received by a Third Party to the extent permitted under Jazz’s agreement with such Third Party.

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. (ii) Jazz shall promptly (and in any event within one (1) Business Day of becoming aware thereof) notify Pfenex of any Regulatory Authority inspections relating specifically to the manufacturing process developed by Pfenex for any HemOnc Product (or any modified version of such manufacturing process for such HemOnc Product) and conducted by Jazz, its Affiliate or any Third Party manufacturer. Jazz shall provide Pfenex with copies a written summary of all materials, correspondence, statements, forms and records received or generated pursuant to any such inspection to which it has access and authority to disclose; provided that Jazz shall only provide Pfenex with any such materials received by a Third Party to the extent permitted under Jazz’s agreement with such Third Partyinspection. In addition to such obligations with respect to Regulatory Authority inspections, Jazz shall promptly (and in any event within one (1) Business Day following receipt thereof) notify Pfenex 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 manufacturing or regulatory status of HemOnc Products; provided that Jazz shall only provide Pfenex with any such information received by a Third Party to the extent permitted under Jazz’s agreement with such Third Party.