Firm Commitments. (a) Provided Company is not in default of this Agreement, [*]. (b) Except as provided in Section 2.5(a) above, [*], as determined by the Manufacturing start dates, shall be [*] for Company to produce such quantities on the delivery dates described therein and for Client to purchase the quantities of API specified therein (the “API Firm Commitment”); [*] shall be [*] upon the Parties. (c) Client understands that to ensure a timely supply of API and Drug Product, it is necessary for Company to Manufacture CML-474 in sufficient volumes to meet the forecasted production requirements for API in Client’s Rolling Forecast. Client understands and agrees that Company shall rely upon the Rolling Forecast to produce such quantities of CML-474 as required to meet the forecasted quantities of API in Client’s Firm Commitment. Client will review plans for CML-474 Manufacturing and the Parties shall agree to the plan to support API supply. (d) With respect to each API Firm Commitment, Client shall submit to Company binding written purchase orders (an “API Firm Order”) confirming the quantity of API ordered and CML-474 as required by Company (which shall be in full Batch quantities), the requested delivery dates, and such other information as Company may find reasonably necessary to Manufacture the API and CML-474, if applicable. Company will confirm acceptance of any API Firm Order (consistent with this Agreement) within [*] of receipt and respond with a schedule of estimated Manufacture start dates and estimated delivery dates. Except as provided in Section 3.10 of this Agreement, the Parties expressly agree that any requested delivery dates shall not be binding on Company and that any timelines represent the Parties’ best estimates of the timing for the various activities or Services to be performed. (e) All purchase orders shall be placed in accordance with this Section 4.2 and no later than nine (9) months prior to the planned Manufacturing start date. Company shall Manufacture and prepare for shipment the quantity of API specified in the API Firm Order and related purchase orders. If requested by Client, Company shall use its commercially reasonable and good faith efforts to deliver quantities in excess of [*] of the applicable API Firm Order subject to available capacity. The API Firm Order shall be made available for shipment in accordance with Section 6.1 (Delivery/Shipment). (f) Company’s acceptance of any API Firm Commitment or purchase order is contingent upon Company’s ability to obtain a DEA quota. Further, Company’s ability to Manufacture designated quantities of API for Client shall be contingent upon Company obtaining a DEA quota sufficient to meet Client’s commercial API demand. Company reserves the right to modify any API Firm Order, as needed, to comply with regulatory requirements, including DEA quota. At the time Company is required by DEA to submit request for controlled substance quota (currently in the month of May of the current year for the following year) Company shall use commercially reasonable efforts to obtain necessary DEA quotas using the most current Rolling Forecast. Additional requests will be made as required based on increases to the API Firm Order.
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Firm Commitments. (a) Provided Company is not in default of this Agreement, [*].
(b) Except as provided in Section 2.5(a) above, [*], as determined by the Manufacturing start dates, shall be [*] for Company to produce and deliver such quantities on the delivery dates described therein therein, and for Client to purchase accept such Batches delivered per the quantities terms of API specified therein this Agreement (the “API Drug Product Firm Commitment”); . [*] shall be [*] upon the Parties].
(c) Client understands that to ensure a timely supply of API and Drug Product, it is necessary for Company to Manufacture CML-474 in sufficient volumes to meet the forecasted production requirements for API in Client’s Rolling Forecast. Client understands and agrees that Company shall rely upon the Rolling Forecast to produce such quantities of CML-474 as required to meet the forecasted quantities of API in Client’s Firm Commitment. Client will review plans for CML-474 Manufacturing and the Parties shall agree to the plan to support API supply.
(d) With respect to each API Drug Product Firm Commitment, Client shall submit to Company binding written purchase orders (an a “API Drug Product Firm Order”) confirming the quantity of API each Drug Product ordered and CML-474 as required by Company (which shall be in full Batch quantities), the requested delivery dates, and such other information as Company may find reasonably necessary to Manufacture the API and CML-474, if applicableordered Drug Product. Company will confirm acceptance of any API Drug Product Firm Order (consistent with this Agreement) within [*] of receipt and respond with a schedule of estimated Manufacture start dates and estimated delivery dates. Except as provided in Section 3.10 of this Agreement, the Parties expressly agree that any requested delivery dates shall not be binding on Company and that any timelines represent the Parties’ best estimates of the timing for the various activities or Services to be performed.
(d) [*]
(e) All purchase orders shall be placed in accordance with this Section 4.2 and no later than nine (9) months prior to the planned Manufacturing start date. [*] Company shall Manufacture and prepare for shipment the quantity of API a Drug Product specified in the API Drug Product Firm Order and related purchase orders. If requested by ClientNotwithstanding the foregoing, with respect to a Drug Product, in no event shall Company be required in any calendar quarter to deliver more than [*] of the quantities in the applicable Drug Product Firm Order applicable to that quarter but Company shall use its commercially reasonable and good faith efforts to deliver quantities in excess of [*] of the applicable API Drug Product Firm Order Order, subject to available capacity. The API Drug Product Firm Order shall be made available for shipment in accordance with Section 6.1 (Delivery/Shipment).
(f) Company’s acceptance of any API Drug Product Firm Commitment or purchase order is contingent upon Company’s ability to obtain a DEA quota. Further, Company’s ability to Manufacture designated quantities of API Drug Product for Client shall be contingent upon Company obtaining a DEA quota sufficient to meet Client’s commercial API Drug Product demand. Company reserves the right to modify any API Drug Product Firm Order, as needed, to comply with regulatory requirements, including DEA quota. At the time Company is required by DEA to submit the necessary request for controlled substance quota to DEA (currently currently, due in the month of May of the current year April, for quota for the following year) Company shall use commercially reasonable efforts to obtain necessary DEA quotas using the most current Rolling Forecast. Additional Company shall make additional requests will be made as required required, based on increases to the API Drug Product Firm Order.
Appears in 1 contract
Firm Commitments. (a) Provided Company is not in default of this Agreement, [*].
(b) Except as provided in Section 2.5(a) above, [*], as determined by the Manufacturing start dates, shall be [*] for Company to produce and deliver such quantities on the delivery dates described therein therein, and for Client to purchase accept such Batches delivered per the quantities terms of API specified therein this Agreement (the “API Drug Product Firm Commitment”); . [*] shall be [*] upon the Parties].
(c) Client understands that to ensure a timely supply of API and Drug Product, it is necessary for Company to Manufacture CML-474 in sufficient volumes to meet the forecasted production requirements for API in Client’s Rolling Forecast. Client understands and agrees that Company shall rely upon the Rolling Forecast to produce such quantities of CML-474 as required to meet the forecasted quantities of API in Client’s Firm Commitment. Client will review plans for CML-474 Manufacturing and the Parties shall agree to the plan to support API supply.
(d) With respect to each API Drug Product Firm Commitment, Client shall submit to Company binding written purchase orders (an a “API Drug Product Firm Order”) confirming the quantity of API each Drug Product ordered and CML-474 as required by Company (which shall be in full Batch quantities), the requested delivery dates, and such other [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. information as Company may find reasonably necessary to Manufacture the API and CML-474, if applicableordered Drug Product. Company will confirm acceptance of any API Drug Product Firm Order (consistent with this Agreement) within [*] of receipt and respond with a schedule of estimated Manufacture start dates and estimated delivery dates. Except as provided in Section 3.10 of this Agreement, the Parties expressly agree that any requested delivery dates shall not be binding on Company and that any timelines represent the Parties’ best estimates of the timing for the various activities or Services to be performed.
(d) [*]
(e) All purchase orders shall be placed in accordance with this Section 4.2 and no later than nine (9) months prior to the planned Manufacturing start date. [*] Company shall Manufacture and prepare for shipment the quantity of API a Drug Product specified in the API Drug Product Firm Order and related purchase orders. If requested by ClientNotwithstanding the foregoing, with respect to a Drug Product, in no event shall Company be required in any calendar quarter to deliver more than [*] of the quantities in the applicable Drug Product Firm Order applicable to that quarter but Company shall use its commercially reasonable and good faith efforts to deliver quantities in excess of [*] of the applicable API Drug Product Firm Order Order, subject to available capacity. The API Drug Product Firm Order shall be made available for shipment in accordance with Section 6.1 (Delivery/Shipment).
(f) Company’s acceptance of any API Drug Product Firm Commitment or purchase order is contingent upon Company’s ability to obtain a DEA quota. Further, Company’s ability to Manufacture designated quantities of API Drug Product for Client shall be contingent upon Company obtaining a DEA quota sufficient to meet Client’s commercial API Drug Product demand. Company reserves the right to modify any API Drug Product Firm Order, as needed, to comply with regulatory requirements, including DEA quota. At the time Company is required by DEA to submit the necessary request for controlled substance quota to DEA (currently currently, due in the month of May of the current year April, for quota for the following year) Company shall use commercially reasonable efforts to obtain necessary DEA quotas using the most current Rolling Forecast. Additional Company shall make additional requests will be made as required required, based on increases to the API Drug Product Firm Order.
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