Examples of Inspected Party in a sentence
The Inspected Party shall cooperate in good faith with the Inspecting Party’s effort to conduct an Assessment.
The Inspected Party shall also provide an opportunity for the JDC to assist in responding to any issues or concerns relating to such inspections, and shall provide copies of all communications to and from any Regulatory Authority relating thereto to the JDC.
The independent auditor retained by the Inspecting Party shall be obligated to execute a reasonable confidentiality agreement with the Inspected Party prior to commencing any such inspection, which, among other customary clauses, contains the provisions to the effect that such auditor shall not disclose to the Inspecting Party any information other than as necessary to accomplish the purpose of the inspection.
The Inspected Party shall cooperate in good faith with the Inspecting Party's effort to conduct an Assessment.
The Inspected Party shall, where practicable, permit representatives of the other Party to participate as observers with respect to such inspection, and shall provide the JDC with a written report of any such inspection, noting with specificity any records or documents reviewed by the regulatory inspector, and including copies of any FDA 483s (or their foreign equivalent) or written communications provided by any Regulatory Authority relating to such inspection.
Such records will be open for inspection at the principal place of business of each party (the “Inspected Party”) during such [ * ] period by an independent auditor chosen by the other party (the “Inspecting Party”) and reasonably acceptable to the Inspected Party for the purpose of verifying the amounts payable by Astellas to FG hereunder or the accuracy of the [ * ] Percentage and/or Fully Burdened Costs.
If either Party or its Affiliates or contractors (an “Inspected Party”) are to be inspected by a Regulatory Authority regarding the Development or Manufacture of a Collaboration Product, in each case within the Field, where relevant, and with respect to the Shared Territory, the Inspected Party shall promptly notify the JDC of the inspection in advance.
In furtherance of the preceding sentence, if the Inspected Party receives a request by a Regulatory Authority in the Shared Territory to inspect any facilities of the other Party, such other Party shall cooperate with and makes its facilities available for such inspection.
The Inspected Party shall also provide an opportunity for the other Party to assist in responding to any issues or concerns relating to such inspections, and shall provide copies of all communications to and from any Government Authority relating thereto to the other Party.
No such inspection by an Inspecting Party shall relieve the Inspected Party of any obligation under this Agreement, the Pharmacovigilance Agreement or the Quality Agreements.