Forecasting and Ordering. (a) No later than the first (1st) day of each calendar quarter, Forty Seven shall supply Lonza with a written forecast showing Forty Seven’s good faith estimated quarterly Commencement Date requirements for Batches to be manufactured within the Assigned Capacity at Lonza’s Facility and any Additional cGMP Batches (as defined below) requested by Forty Seven to be manufactured at Lonza’s Facility in the following [*] month period or the remainder of the Term, whichever is less (the “Forecast”). No later than [*] days following Lonza’s receipt of a Forecast, Lonza shall provide written notice to Forty Seven of whether it has (as of the date of receipt of the Forecast) capacity available to manufacture the number of Batches forecasted therein in accordance with the schedule proposed by Forty Seven and shall provide Forty Seven with an estimated production schedule showing the estimated Commencement Date and estimated delivery date of each Batch (“Forecast Response”). The forecast and notice of available capacity given in this Clause 6.3 shall not be binding on Forty Seven or Lonza, except as otherwise set forth in Clause 6.1. For the avoidance of doubt, no notice from Lonza to Forth Seven provided pursuant to this Clause 6.3 shall relieve Lonza of its obligations under Clause 6.1, except as permitted by Clause 6.4. (b) Forty Seven may place firm purchase orders for its requirement for Additional cGMP Batches at least [*] months prior to the desired Commencement Date of each such Batch unless otherwise mutually agreed. Lonza shall accept or reject Forty Seven’s orders for Additional cGMP Batches within [*] calendar days of Lonza’s receipt of the purchase order; provided that if Lonza fails to accept or reject a purchase order within such [*] calendar day period, [*]. Lonza shall use commercially reasonable efforts to accept all purchase orders submitted by Forty Seven in accordance with this Section 6.3(b). Each accepted purchase order is a “Binding Purchase Order.” All Binding Purchase Orders shall be subject to the cancellation provisions in Clause 6.5.
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Samples: Assigned Capacity and Manufacturing Agreement (Forty Seven, Inc.), Assigned Capacity and Manufacturing Agreement (Forty Seven, Inc.), Assigned Capacity and Manufacturing Agreement (Forty Seven, Inc.)
Forecasting and Ordering. (a) No later than To enable planning of Intermediate and Final Product and purchase of necessary Raw Materials, the first (1st) day of each calendar quarter, Forty Seven Project Managers shall supply on a regular basis discuss Customer's future demand and Customer shall on a quarterly basis provide Lonza with a written forecast showing Forty SevenCustomer’s good faith non-binding estimated quarterly Commencement Date requirements for Batches to be manufactured within the Assigned Capacity at Lonza’s Facility and any Additional cGMP Batches (as defined below) requested by Forty Seven to be manufactured at Lonza’s Facility in for the following [*] month period or the remainder redacted]period for manufacturing and delivery of the TermFinal Product, whichever is less including a [redacted]forecast for manufacturing of Intermediate and Final Product (such [redacted]forecast, the “Forecast”). Subject to the physical limitations of the Facility, the manufacturing process and the availability of Raw Materials, the final scheduling and rescheduling of Commencement Dates shall be determined by Customer, in consultation with Lonza. No later than [*] days following redacted]following Lonza’s receipt of a such Forecast, Lonza shall provide written notice Customer with a reasonable estimated production plan and schedule (for the production of Intermediate, the production of Final Product, and the conversion of Intermediate into Final Product) showing the estimated Commencement Dates, proposed Purchase Order dates and delivery dates for Product as necessary to Forty Seven meet the Forecast (the “Production Plan”). Unless otherwise agreed between the Parties, the Production Plan will provide for the following:
8.1.1 Lonza’s proposed Commencement Dates shall allow for the manufacture and delivery of whether it has (as of the date of receipt of the Forecast) capacity available to manufacture the number of Batches forecasted therein Product in accordance with the schedule proposed by Forty Seven Forecast and shall provide Forty Seven be driven by Customer, in consultation with an estimated production schedule showing Lonza. Lonza will move Commencement Dates as reasonably requested by Customer.
8.1.2 Subject to the estimated Maximum Annual Capacity of the Facility, if Cyclosporin A (and Intermediate in respect of Clause 8.1.2(c)) will be on hand as of the proposed Commencement Date:
(a) for the manufacture of Final Product as contemplated in Clause 8.2.3, the Commencement Date and estimated delivery date shall be no more than [redacted]from the issuance of each Batch (“Forecast Response”). The forecast and notice of available capacity given the Purchase Order set out in this Clause 6.3 shall not be binding on Forty Seven or Lonza, except as otherwise set forth in Clause 6.1. For the avoidance of doubt, no notice from Lonza to Forth Seven provided pursuant to this Clause 6.3 shall relieve Lonza of its obligations under Clause 6.1, except as permitted by Clause 6.4.Production Plan; and
(b) Forty Seven may place firm purchase orders for its requirement for Additional cGMP Batches at least [*] months prior to the desired manufacture of Intermediate as contemplated in Clause 8.2.4, the Commencement Date of each such Batch unless otherwise mutually agreed. Lonza shall accept or reject Forty Seven’s orders for Additional cGMP Batches within be no more than [*] calendar days of Lonza’s receipt redacted]from the issuance of the purchase orderPurchase Order set out in the Production Plan; provided that if Lonza fails to accept or reject a purchase order within such and
(c) for the conversion of Intermediate into Final Product as contemplated in Clause 8.2.5, the Commencement Date shall be no more than [*] calendar day periodredacted]from the issuance of the Purchase Order set out in the Production Plan.
8.1.3 If Cyclosporin A will not otherwise be on hand as of the proposed Commencement Date:
(a) for the manufacture of Final Product as contemplated in Clause 8.2.3, [*]. Lonza the Commencement Date shall use commercially reasonable efforts to accept all purchase orders submitted by Forty Seven be no more than twelve (12) months from the issuance of the Purchase Order set out in accordance with this Section 6.3(b)the Production Plan; and
(b) for the manufacture of Intermediate as contemplated in Clause 8.2.4, the Commencement Date shall be no more than twelve (12) months from the issuance of the Purchase Order set out in the Production Plan. Each accepted Purchase Order triggers the purchase order is a “Binding Purchase Orderof Raw Materials including Cyclosporin A in advance of the Commencement Date. If the lead time for Cyclosporin A changes, the Parties will adjust the timelines set out in this Clause.” All Binding Purchase Orders shall be subject to the cancellation provisions in Clause 6.5.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Aurinia Pharmaceuticals Inc.)
Forecasting and Ordering. (a) No later than 5.1 During the first (1st) day of Commercial Phase the following shall apply:
5.1.1 Prior to 30th October in each calendar quarterCalendar Year, Forty Seven AstraZeneca shall supply Lonza provide CIMA with a written forecast showing Forty Seven’s good faith estimated quarterly Commencement Date ("THE ANNUAL FORECAST") of AstraZeneca's annual requirements for Batches the Product and Placebo for each Calendar Quarter of the subsequent Calendar Year which will be expressed in terms of formulation batches, each formulation batch being not less than equal to be manufactured within the Assigned Capacity at Lonza’s Facility and any Additional cGMP Batches (as defined below) requested by Forty Seven to be manufactured at Lonza’s Facility in the following [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] month period or the remainder of the Term(a "BATCH").
5.1.2 In each Calendar Year after 2002, whichever is AstraZeneca shall be obliged to purchase not less (the “Forecast”). No later than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] days following Lonza’s receipt of a Forecast, Lonza shall provide written notice to Forty Seven of whether it has (as of the date of receipt Annual Forecast for Product and CIMA shall be obliged to supply up to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of the Forecast) capacity available to manufacture Annual Forecast for Product prorated equally throughout the number of Batches forecasted therein in accordance with the schedule proposed by Forty Seven and shall provide Forty Seven with an estimated production schedule showing the estimated Commencement Date and estimated delivery date of each Batch (“Forecast Response”). The forecast and notice of available capacity given in this Clause 6.3 shall not be binding on Forty Seven or Lonza, except as otherwise set forth in Clause 6.1. year.
5.1.3 For the avoidance of doubt, no notice from Lonza CIMA shall not be obliged at any time to Forth Seven provided pursuant supply more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES Exhibit 10.1 AND EXCHANGE COMMISSION.***] of the Annual Forecast in 5.1.2 or more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] tablets (product plus placebo combined), whichever is the smaller, in any given Calendar Year unless the Parties agree otherwise.
5.1.4 In the event that AstraZeneca does forecast to this Clause 6.3 require more than such maximum quantity, CIMA shall relieve Lonza immediately notify AstraZeneca of its obligations under Clause 6.1, except as permitted by Clause 6.4receipt of such a forecast and CIMA is obliged to inform AstraZeneca in writing within thirty (30) days of receipt of such forecast what quantity (if any) above the maximum forecast quantity CIMA is able to supply.
(b) Forty Seven may place firm purchase orders for its requirement for Additional cGMP Batches 5.1.5 In order to assist CIMA's production planning, AstraZeneca shall, at least [*] months prior to the desired Commencement Date end of each such Batch unless otherwise mutually agreed. Lonza shall accept or reject Forty Seven’s orders Calendar Quarter provide to CIMA a non-binding update of AstraZeneca's requirements for Additional cGMP Batches within [*] Product and Placebo for the next fifteen calendar days of Lonza’s receipt of months, with the purchase order; provided that if Lonza fails to accept or reject a purchase order within such [*] calendar day period, [*]. Lonza shall use commercially reasonable efforts to accept all purchase orders submitted first six (6) month-by-month and the remainder by Forty Seven in accordance with this Section 6.3(b). Each accepted purchase order is a “Binding Purchase Orderquarter.” All Binding Purchase Orders shall be subject to the cancellation provisions in Clause 6.5.
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Samples: Supply Agreement (Cima Labs Inc)