Common use of Other Product Specific Inspections Clause in Contracts

Other Product Specific Inspections. In the case of an inspection (other than the Product Pre-Approval Inspection) by a Regulatory Authority that directly affects the Production of Products, the following shall apply: (a) XXXXXX immediately shall inform CLIENT of the notice of such inspection; (b) XXXXXX shall permit a representative of CLIENT (who shall be selected by XXXXXX from a list of senior representatives reasonably provided by CLIENT) to be present at the XXXXXX facility that is the subject of such inspection (but not to be present at the inspection or to participate, except as requested by XXXXXX); (c) XXXXXX shall permit such representative of CLIENT to be present at, and participate in, each daily wrap up session for such inspection and the post-inspection wrap up session for such inspection; (d) XXXXXX promptly shall provide CLIENT with copies of all written materials, including without limitation copies of any Notice of Inspection (FDA Form 482), other notice of inspection, notice of violation, other similar notice, or Inspectional Observations (FDA Form 483) received by XXXXXX relating to such inspection, and (e) XXXXXX shall provide CLIENT with advance copies of all proposed responses to any such inspections, notices or actions, shall permit CLIENT reasonable opportunity to review and comment on each such response, shall reasonably consider CLIENT's reasonable comments thereon, and shall provide CLIENT with copies of each such response as submitted.

Other Product Specific Inspections. In the case of an inspection (other than the Standalone Product Pre-Approval Inspection) by a Regulatory Authority that directly affects the Production of ProductsStandalone Product, the following shall apply: (a) XXXXXX Bxxxxx immediately shall inform CLIENT Halozyme of the notice of such inspection; (b) XXXXXX Bxxxxx shall permit a representative of CLIENT (who shall be selected by XXXXXX from a list of senior representatives reasonably provided by CLIENT) Halozyme to be present at the XXXXXX Bxxxxx facility that is the subject of such inspection (but not to be present at the inspection or to participate, except to be available on an as-needed basis as requested by XXXXXXBxxxxx); (c) XXXXXX Bxxxxx shall permit apprise such representative of CLIENT to be present at, and participate in, Halozyme regarding each daily wrap up session for such inspection and the post-inspection wrap up session for such inspection; (d) XXXXXX Bxxxxx promptly shall provide CLIENT Halozyme with copies of all written materials, including without limitation copies of any Notice of Inspection (FDA Form 482), other notice of inspection, notice of violation, other similar notice, or Inspectional Observations (FDA Form 483, its foreign equivalent and Establishment Inspection Reports) received by XXXXXX Bxxxxx relating to such inspection, and (e) XXXXXX Bxxxxx shall provide CLIENT Halozyme with advance copies of all proposed responses that directly affect Production of Standalone Product to any such inspections, notices or actions, shall permit CLIENT Halozyme reasonable opportunity to review and comment on each such response, shall reasonably consider CLIENT's Halozyme’s reasonable comments thereon, and shall provide CLIENT Halozyme with copies of each such response as submitted.

Other Product Specific Inspections. In the case of an inspection (other than the Product Pre-Approval Inspection) by a Regulatory Authority that directly affects the Production of Products, the following shall apply: (a) XXXXXX Xxxxxx immediately shall inform CLIENT Halozyme of the notice of such inspection; (b) XXXXXX Xxxxxx shall permit a representative of CLIENT (who shall be selected by XXXXXX from a list of senior representatives reasonably provided by CLIENT) Halozyme to be present at the XXXXXX Xxxxxx facility that is the subject of such inspection (but not to be present at the inspection or to participate, except to be available on an as-needed basis as requested by XXXXXXXxxxxx); (c) XXXXXX Xxxxxx shall permit apprise such representative of CLIENT to be present at, and participate in, Halozyme regarding each daily wrap up session for such inspection and the post-inspection wrap up session for such inspection; (d) XXXXXX Xxxxxx promptly shall provide CLIENT Halozyme with copies of all written materials, including without limitation copies of any Notice of Inspection (FDA Form 482), other notice of inspection, notice of violation, other similar notice, or Inspectional Observations (FDA Form 483, its foreign equivalent and Establishment Inspection Reports) received by XXXXXX Xxxxxx relating to such inspection, and (e) XXXXXX Xxxxxx shall provide CLIENT Halozyme with advance copies of all proposed responses that directly affect Production of Product to any such inspections, notices or actions, shall permit CLIENT Halozyme reasonable opportunity to review and comment on each such response, shall reasonably consider CLIENTHalozyme's reasonable comments thereon, and shall provide CLIENT Halozyme with copies of each such response as submitted.