Common use of Commercial Supply Agreement Clause in Contracts

Commercial Supply Agreement. Following execution of this Agreement, BioNumerik agrees to finalize its processes for the manufacture of Product(s) as shall be agreed from time to time between itself and ASTA Medica. Within 24 months prior to the estimated time of the first commercial sale of Product(s) in the Territory, ASTA Medica and BioNumerik shall enter into a commercial supply agreement (the "Supply Agreement") to be negotiated in good faith and to reflect such terms and conditions as shall be reasonably necessary to govern the manufacture and supply of Product(s) for sale and distribution in the Territory. The Supply Agreement will provide among other things that: (a) Not later than the end of each calendar year that commences after execution of the Supply Agreement, ASTA Medica will supply to BioNumerik an estimate of its requirements of the amount of API or finished Product(s) in the Territory during the following [**] years, and will update this estimate at six-month intervals. BioNumerik will notify ASTA Medica within 90 days of receipt of such estimate if it (or its Affiliates) will be unable to supply the whole or any part of the requirements described in such estimate. Together with the [**] estimate, ASTA Medica will deliver to BioNumerik firm orders for its estimated requirements of Product(s) not less than 12 months in advance of the required date of delivery. Within thirty (30) days of its receipt of such firm order, BioNumerik shall confirm such order in writing and fulfill such orders in accordance with ASTA Medica's required date of delivery provided the quantities specified therein do not exceed those quantities contained in the previous estimate for the same period and provided that BioNumerik has not previously advised ASTA Medica that it will be unable to supply all or part of such quantities. [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (b) If BioNumerik (or its Affiliates) are unable to meet the requirements of ASTA Medica and its Affiliates and sublicensees for commercial quantities of Product(s), then ASTA Medica may fill all of its remaining supply requirements in excess of the amount provided by BioNumerik (and its Affiliates) from a third party or parties. In such event, (i) BioNumerik shall grant a license to ASTA Medica under the BioNumerik Patent Rights, BioNumerik Know-How, and BioNumerik Improvements to manufacture and have such third party manufacture Product(s) for the purpose of allowing such remaining supply requirements to be filled, and (ii) BioNumerik shall also provide such information and reasonable assistance as may be necessary to allow such third party to manufacture Product(s) for the purpose of allowing such remaining supply requirements to be filled. (c) The cost of the Product(s) under the Supply Agreement will be based on [**]. (d) ASTA Medica shall be entitled to have BioNumerik's cost of manufacture and overhead confirmed by an independent firm of accountants to which BioNumerik has no reasonable objection, but not more than once in any 12 month period, provided, however, that such firm of accountants shall only report to ASTA Medica the amount of such costs, including overhead, and shall keep confidential all other information acquired in the course of the examination. ASTA Medica shall pay the cost of any such audit and the audit shall be conducted so that it will not disrupt BioNumerik's ongoing business activities. The Parties in good faith shall negotiate all other terms of supply and purchase to be included in the Supply Agreement.

Commercial Supply Agreement. Following execution of this Agreement, BioNumerik agrees to finalize its processes for the manufacture of Product(s) as shall be agreed from time to time between itself and ASTA Medica. Within 24 months prior to the estimated time of the first commercial sale of Product(s) in the Territory, ASTA Medica and BioNumerik shall enter into a commercial supply agreement (the "Supply Agreement") to be negotiated in good faith and to reflect such terms and conditions as shall be reasonably necessary to govern the manufacture and supply of Product(s) for sale and distribution in the Territory. The Supply Agreement will provide among other things that: (a) Not later than the end of each calendar year that commences after execution of the Supply Agreement, ASTA Medica will supply to BioNumerik an estimate of its requirements of the amount of API or finished Product(s) in the Territory during the following [**] years, and will update this estimate at six-month intervals. BioNumerik will notify ASTA Medica within 90 days of receipt of such estimate if it (or its Affiliates) will be unable to supply the whole or any part of the requirements described in such estimate. Together with the [**] estimate, ASTA Medica will deliver to BioNumerik firm orders for its estimated requirements of Product(s) not less than 12 months in advance of the required date of delivery. Within thirty (30) days of its receipt of such firm order, BioNumerik shall confirm such order in writing and fulfill such orders in accordance with ASTA Medica's required date of delivery provided the quantities specified therein do not exceed those quantities contained in the previous estimate for the same period and provided that BioNumerik has not previously advised ASTA Medica that it will be unable to supply all or part of such quantities. [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONCOMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (b) If BioNumerik (or its Affiliates) are unable to meet the requirements of ASTA Medica and its Affiliates and sublicensees for commercial quantities of Product(s), then ASTA Medica may fill all of its remaining supply requirements in excess of the amount provided by BioNumerik (and its Affiliates) from a third party or parties. In such event, (i) BioNumerik shall grant a license to ASTA Medica under the BioNumerik Patent Rights, BioNumerik Know-How, and BioNumerik Improvements to manufacture and have such third party manufacture Product(s) for the purpose of allowing such remaining supply requirements to be filled, and (ii) BioNumerik shall also provide such information and reasonable assistance as may be necessary to allow such third party to manufacture Product(s) for the purpose of allowing such remaining supply requirements to be filled. (c) The cost of the Product(s) under the Supply Agreement will be based on [**]. (d) ASTA Medica shall be entitled to have BioNumerik's cost of manufacture and overhead confirmed by an independent firm of accountants to which BioNumerik has no reasonable objection, but not more than once in any 12 month period, provided, however, that such firm of accountants shall only report to ASTA Medica the amount of such costs, including overhead, and shall keep confidential all other information acquired in the course of the examination. ASTA Medica shall pay the cost of any such audit and the audit shall be conducted so that it will not disrupt BioNumerik's ongoing business activities. The Parties in good faith shall negotiate all other terms of supply and purchase to be included in the Supply Agreement.