Minimum Commitments. a) During the period from the Effective Date to the First Submission (the “Clinical Period”): i) CPP shall purchase from sanofi-aventis at least the Minimum Clinical Commitment of Products; and ii) CPP shall place an order for at least one initial regulatory filing registration batch for the United States within thirty–six (36) months after the Effective Date. b) During the period commencing six months after the date of the First Submission and until the first Regulatory Approval of a Product in any country or other jurisdiction, no later than the first day of each calendar quarter, CPP shall submit to sanofi-aventis an updated rolling forecast for its planned orders for Commercial Products, which shall be non-binding and shall be for planning purposes only (each a “Pre-Approval Commercial Forecast”). c) During the period commencing on the date of the first Regulatory Approval and for the duration of the Term, (the “Commercial Period”), i) CPP shall submit Commercial Demand Forecasts in accordance with Section 6.2 of this Agreement; and ii) CPP shall purchase at least the Minimum Annual Commercial Commitment of Products from sanofi-aventis. d) CPP shall be required to place an order for commercial supply to support a Product launch within six (6) months of obtaining Regulatory Approval.
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Sources: Product Manufacturing & Supply Agreement (Cancer Prevention Pharmaceuticals, Inc.), Product Manufacturing & Supply Agreement (Cancer Prevention Pharmaceuticals, Inc.)