PFIZER Back-Up Manufacturing Facilities Sample Clauses

PFIZER Back-Up Manufacturing Facilities. If, after approval of an NDA for a Product, additional back-up manufacturing facilities are required, PFIZER shall have the option, at its sole cost and expense, to request XXXXXX-XXXXXXX to file a supplement to have one or more of PFIZER's or any of its Affiliate's manufacturing facilities (the "PFIZER Facilities") qualified and approved as back-up manufacturing facilities. If PFIZER desires to have any of its facilities so qualified, PFIZER shall notify XXXXXX-XXXXXXX of the identity of such PFIZER Facilities and the back-up manufacturing services to be provided promptly after PFIZER has made this determination. XXXXXX-XXXXXXX shall have the right to visit and audit such PFIZER Facilities and review all other appropriate technical information to determine whether such PFIZER Facilities are acceptable, such consent not to be unreasonably withheld. If approved by XXXXXX-XXXXXXX, XXXXXX-XXXXXXX shall have the right to provide reasonable technical assistance in the qualification and approval of such PFIZER Facilities at the cost and expense of PFIZER. XXXXXX-XXXXXXX shall be solely responsible for filing all submissions or other correspondence with the FDA and/or other Governmental or Regulatory Authorities in connection with any decision to seek approval of a PFIZER Facility as an additional back-up manufacturing facility. XXXXXX-XXXXXXX shall also be responsible for determining technical and other conditions set forth in any supplement filed with reference to this Section. XXXXXX-XXXXXXX shall have the sole right to determine whether or not to use the PFIZER Facilities in the event of an interruption or depletion in supply of Product and, under such circumstances, a separate manufacturing agreement will be entered into between the parties.
Sample 1
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Related to PFIZER Back-Up Manufacturing Facilities

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