Orders and Shipments. 7.1. ▇▇▇▇▇▇ and ▇▇▇▇▇▇ will keep each other informed with respect to activities and undertakings in respect of their obligations hereunder, including without limitation, progress in the development of scaled-up manufacturing processes for the Substance and the Product and the status and progress of the patent litigation contemplated by Article 13.1 hereof to the end that Parties will jointly estimate the beginning date of the first Commercial Year not less than 24 months in advance of the beginning date of the first Commercial Year ("Joint Estimate Date"). The Joint Estimate Date shall not be less than 28 months from the date of ▇▇▇▇▇▇'▇ submission of the ANDA to the FDA. 7.2. The Parties recognize that determining the Joint Estimate Date is inherently speculative. Therefore, neither party will hold the other party liable hereunder in the event that the Joint Estimate Date ultimately proves to be incorrect. 7.3. On the date the parties determine the Joint Estimate Date, ▇▇▇▇▇▇ will provide ▇▇▇▇▇▇ with a good faith estimate of ▇▇▇▇▇▇'▇ maximum annual requirements of the Substance as of the Joint Estimate Date. If, in any subsequent Commercial Year of this Agreement, ▇▇▇▇▇▇ determines that its future annual maximum requirements for the Substance will exceed Rhode's manufacturing capacity for the Substance, ▇▇▇▇▇▇ shall send ▇▇▇▇▇▇ 18 months advance written notice of ▇▇▇▇▇▇'▇ projected additional maximum annual requirements and ▇▇▇▇▇▇ may, in its sole discretion, determine whether or not to increase its capacity for producing the Substance in order to meet ▇▇▇▇▇▇'▇ additional requirements. ▇▇▇▇▇▇ shall notify ▇▇▇▇▇▇ as promptly as possible of its decision in this regard. 7.4. At least ninety (90) days prior to the commencement of a Commercial Year, ▇▇▇▇▇▇ shall present to ▇▇▇▇▇▇ ▇▇▇▇▇▇'▇ best estimate of its annual requirements for the Substance during the upcoming Commercial Year on a quarterly basis. ▇▇▇▇▇▇ will also notify ▇▇▇▇▇▇ at least sixty (60) days before each quarter of its estimated monthly requirements for that and the next quarter which requirements will supersede those provided pursuant to the above annual forecast. ▇▇▇▇▇▇ will base resources decisions at the Coventry Plant on ▇▇▇▇▇▇'▇ annual estimated purchases and thus ▇▇▇▇▇▇'▇ failure to achieve those estimated purchases will result in year end cost adjustments by ▇▇▇▇▇▇. 7.5. ▇▇▇▇▇▇ will place firm orders for the Substance at least forty-five (45) days before each required shipment date. Both Parties agree to work together to reduce lead time for orders and deliveries. 7.6. ▇▇▇▇▇▇ will accept deliveries of Substance from ▇▇▇▇▇▇ based on orders placed pursuant to this Article 7. ▇▇▇▇▇▇ will not be required to deliver, in any calendar year, additional quantities of Substance exceeding ten percent (10%) of the quantity of ▇▇▇▇▇▇'▇ annual estimated purchases for that Commercial Year provided by ▇▇▇▇▇▇ under Article 7.
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Orders and Shipments. 7.15.1. ▇▇▇▇▇▇ and ▇▇▇▇▇▇ will keep each other informed with respect to activities and undertakings in respect of their obligations hereunder, including without limitation, progress in the development of scaled-up manufacturing processes for the Substance and the Product and the status and progress Within ninety (90) days of the patent litigation contemplated by Article 13.1 hereof to the end that Parties will jointly estimate the beginning date of the first Commercial Year not less than 24 months in advance of the beginning date of the first Commercial Year ("Joint Estimate Date"). The Joint Estimate Date shall not be less than 28 months from the date of ▇▇▇▇▇▇'▇ submission of the ANDA to the FDA.
7.2. The Parties recognize that determining the Joint Estimate Date is inherently speculative. Thereforehereof, neither party will hold the other party liable hereunder in the event that the Joint Estimate Date ultimately proves to be incorrect.
7.3. On the date the parties determine the Joint Estimate Date, ▇▇▇▇▇▇ will provide ▇▇▇▇▇▇ with a good faith estimate of ▇▇▇▇▇▇'▇ maximum annual requirements of the Substance as of the Joint Estimate Date. If, in any subsequent Commercial Year of this Agreement, ▇▇▇▇▇▇ determines that its future annual maximum requirements for the Substance will exceed Rhode's manufacturing capacity for the Substance, ▇▇▇▇▇▇ shall send ▇▇▇▇▇▇ 18 months advance written notice of ▇▇▇▇▇▇'▇ projected additional maximum annual requirements and ▇▇▇▇▇▇ may, in its sole discretion, determine whether or not to increase its capacity for producing the Substance in order to meet ▇▇▇▇▇▇'▇ additional requirements. ▇▇▇▇▇▇ shall notify ▇▇▇▇▇▇ as promptly as possible of its decision in this regard.
7.4. At at least ninety (90) days prior to the commencement of a Commercial Yeareach calendar year during the term of this Agreement, ▇▇▇▇▇▇ shall present to ▇▇▇▇▇▇ ▇▇▇▇▇▇'▇ best estimate of Key will furnish ABI with its annual projected requirements for the Substance Licensed Product during the upcoming Commercial Year on a quarterly basisnext succeeding calendar year. ▇▇▇▇▇▇ will also notify ▇▇▇▇▇▇ Key may amend its projected requirements from time-to-time, provided, however, that ABI shall be obligated only to make its best effort to comply with any requests in excess of annual projections received by it at least sixty ninety (6090) days before each quarter of its estimated monthly requirements for that and the next quarter which requirements will supersede those provided pursuant prior to the above annual forecastcommencement of the calendar year in question. ▇▇▇▇▇▇ will base resources decisions at the Coventry Plant on ▇▇▇▇▇▇'▇ annual estimated purchases and thus ▇▇▇▇▇▇'▇ failure to achieve those estimated purchases will result in year end cost adjustments by ▇▇▇▇▇▇.
7.5. ▇▇▇▇▇▇ will place firm orders for the Substance at least forty-five (45) days before each required shipment date. Both Parties agree to work together to reduce lead time for orders and deliveries.
7.6. ▇▇▇▇▇▇ will accept deliveries of Substance from ▇▇▇▇▇▇ based on orders placed pursuant to this Article 7. ▇▇▇▇▇▇ will not Under no circumstances shall ABI be required to deliverdeliver to Key hereunder, an amount of Licensed Product which exceeds the amount ABI is able, in any calendar yeargood faith, additional to acquire from HBL, or from HBL's contract manufacturers. The exact composition of Licensed Product shall be disclosed in writing by ABI to Key. Subject to the foregoing, ABI shall use its best efforts to deliver Licensed Product in accordance with Key's projected requirements and product specifications.
5.2. ABI shall ship product within thirty (30) days of request by Key, against an irrevocable letter of credit on a U.S. bank (or other financial surety acceptable to ABI or to the agent nominated by ABI) in an amount sufficient to cover the CIF price payable to ABI or the agent nominated by ABI under Paragraph 4.1 above. The letter of credit shall be issued by a financial institution acceptable to ABI or to the agent nominated by ABI, shall be in U.S. dollars and shall not expire until the final payment for the respective shipment has been made to ABI or to the agent nominated by ABI.
5.3. Orders of Licensed Product for commercial sales shall be made for minimum quantities of Substance exceeding ten percent (10%) 250,000 Doses. Key shall meet or exceed the following annual minimum purchases from ABI. If Key does not achieve these levels, it will have the opportunity to make up the difference by either purchasing product or by cash payment within 60 days of the quantity end of ▇▇▇▇▇▇'▇ annual estimated purchases for that Commercial Year provided by ▇▇▇▇▇▇ the period. Otherwise, ABI will have the right to make the Agreement non-exclusive, and appoint another licensee or market the Product under Article 7.the ABI name. 1st twelve months after launch $ 180,000 net of shipping and packaging 2nd twelve months after launch $ 220,000 net of shipping and packaging 3rd twelve months after launch and beyond $ 270,000 net of shipping and packaging
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Sources: License and Supply Agreement (Amarillo Biosciences Inc)