Common use of Forecasts and Orders Clause in Contracts

Forecasts and Orders. 7.7.1. Not less than [*] prior to the first day of each Calendar Quarter (commencing with the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder), IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Product for each of [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.

Appears in 1 contract

Sources: Exclusive License and Supply Agreement (Actinium Pharmaceuticals, Inc.)

Forecasts and Orders. 7.7.13.1 Forecasting and ordering of Product(s) under this Agreement shall be conducted: (A) on a pull Manufacturing basis in respect of the Products as set out in clauses 3.2 and 3.4; or (B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and (C) on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements for Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”). (A) Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2. (B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. Not less than [*] The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the first day Effective Date. (C) Provided that the volumes of Products shown in the Firm Zone of each Calendar Quarter (commencing Forecast Schedule align with the first Calendar Quarter requirements of the Gating Plan in which IMMEDICA respect of such Products, such volumes shall be deemed to be firm orders Product from binding on the LICENSOR hereunder)Purchaser and the Supplier, IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Product quantities included for each of [*] Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “ForecastFirm Order”). IMMEDICA Each Firm Order shall be for not increase less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or decrease more multiples of the quantity estimated for [*] Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E). (D) The Purchaser shall submit each Forecast from Schedule either electronically or by such other means that the quantity estimated for Manufacturing and Supply Team shall determine and to such periods location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the previous Forecastvolumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products). (E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan): (i) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and (ii) within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required. In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The quantities estimated for all subsequent Calendar Quarters response (or deemed response) will include confirmation of each Forecast the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser: (iii) accepts such amendments, the Firm Order together with the relevant amendments shall be non-bindingdeemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or (iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, and for planning purposes onlybut not more than five (5) Business Days following such rejection. By way of example, The Parties agree that if IMMEDICA issues a forecast on [*], [*] the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the forecasts applicable Gating Plan, provided that the Supplier may refer the matter for [*] resolution in accordance with clause 16 (Dispute Escalation), in which case such matter shall not be binding on determined in accordance with clause 16 (Dispute Escalation). (F) The Purchaser, either electronically or by such other means determined by the Manufacturing and Supply Team, shall deliver to the Supplier purchase orders corresponding to the Product volumes shown in the Firm Orders to such location as reasonably requested by the Supplier in writing. The purchase order shall be in such form as is mutually agreed by the Manufacturing and Supply Team and shall specify the Product(s) and country(ies) to which it relates; have assigned to it a number which shall be used by the Parties in all correspondence relating thereto and shall be submitted in accordance with the Lead Times set out in Exhibit 1 (Products) and the applicable Firm Zone for the Product(s) shown in each Firm Order so that the Supplier may process the Firm Orders. (G) The Supplier will supply Product in accordance with Firm Orders that comply with this clause 3.2 and the applicable Gating Plan and for which the Supplier receives purchase orders in accordance with clause 3.2(F), unless such requirements are changed in accordance with clause 3.2(H) or clause 3.2(I). (H) Without prejudice to the Parties. In addition’ obligations with respect to the Firm Zone of any Forecast Schedule, IMMEDICA if discussion of the relevant requirements of a Firm Order is requested by the Supplier, then the relevant planning personnel from both Parties will provide on a country-by-country basis its discuss in good faith estimated number of patients faith, provided that the Supplier shall have no obligation to be treated agree any production schedule or Delivery timetable which would exceed the applicable Gating Volumes for the relevant Product as set out in the Forecast Gating Plan for that Gating Year. (I) The Purchaser and the Supplier shall each establish a single point of ordering and forecasting in respect of Products for the purposes of LICENSOR providing dosimetric doses carrying out its obligations under this clause 3.2, subject to any agreed delegation of the Product. LICENSOR will supply dosimetric doses based on such Forecast and/or invoicing and/or payment to Nominated Suppliers or other Affiliates of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients Party in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Alcon Inc)

Forecasts and Orders. 7.7.15.1 During the term of this Agreement, Baxter will submit to Oravax, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. Not less The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than [*] prior to the first tenth (10th) day of each Calendar Quarter calendar month, specifying ▇▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (commencing 12) month period covered by Baxter Requirements Schedule. 5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period. 5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date. 5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first Calendar Quarter month of the Forecast contained in the immediately preceding Baxter Requirements Schedule. 5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to Baxter additional Products in excess of that ordered or contained in the relevant Baxter Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments. 5.6 Oravax shall be entitled to treat the Firm Period as a binding order of ▇▇▇▇▇▇ and to purchase raw materials and to allocate Back to Contents production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times. 5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to ▇▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until ▇▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder. 5.8 ▇▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery .Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which IMMEDICA orders ▇▇▇▇▇▇ may reject the Products. If ▇▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indicationof the reasons for rejection. ▇▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify ▇▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts ▇▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or ▇▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by ▇▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the LICENSOR hereunder), IMMEDICA Batch or Batches in dispute. The independent laboratory shall prepare act as expert not arbitrator and provide the LICENSOR with a written forecast cost of its good faith estimated requirements for Product for each of [*] (each a “Forecast”)analysis shall be paid by the Party against whom the laboratory findings were made. IMMEDICA Two samples shall not increase or decrease the quantity estimated for [*] of each Forecast be supplied by ▇▇▇▇▇▇ from the quantity estimated for such periods Batches in the previous Forecastquestion and by Oravax from any samples that it has retained. The quantities estimated for all subsequent Calendar Quarters results of each Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] the said analysis shall be binding on ▇▇▇▇▇▇ and Oravax, but upon receiptthereof ▇▇▇▇▇▇ and Oravax shall meet to discuss in good faith the Parties failure of the Batch in question and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses resolution of the Product. LICENSOR will supply dosimetric doses based on such Forecast dispute between them. 5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to ▇▇▇▇▇▇ a sufficient quantity of the Product in a manner it reasonably believes most efficient, provided however, it will ensure to replace the defective Batch or Batches. If ▇▇▇▇▇▇ accepts that dosimetric doses are supplied to all identified patients the relevant Batches of Product were Manufactured in accordance with the terms Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to ▇▇▇▇▇▇ in respect of this Agreementsuch Batches. Therapeutic doses Should ▇▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product will be supplied on a per patient basis pursuant to the terms Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32. 5.10 If, in any calendar year of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent ForecastAgreement beginning 2005, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 Manufacturing Fees received by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is Oravax are less than the quantity specified in sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the binding [*] “Minimum Payment”), Oravax shall invoice ▇▇▇▇▇▇ for the amount of the Forecasts provided under Section 7.7.1, IMMEDICA difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and ▇▇▇▇▇▇ shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots pay to manufacture Product that was not subsequently ordered, subject to Oravax the provision by LICENSOR of appropoirate evidence amount of such costs and to the extent that difference within thirty (30) days of receipt of such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSORnotice.

Appears in 1 contract

Sources: Contract Manufacturing Agreement (Acambis PLC)

Forecasts and Orders. 7.7.13.1 In order to assist Supplier in planning production, Novartis shall, on or before the tenth (10th) day of each month, provide Supplier with a twelve (12) month rolling forecast of the quantities of Products required by Novartis, by month, for the following twelve (12) months. Not less It is understood that such forecasts are intended to be estimates only, and shall not be binding upon Novartis. Notwithstanding the foregoing, Novartis shall be bound to purchase from Supplier [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of those quantities of Products set forth in each such forecast as being Novartis' requirements of Products for the first three (3) months of each twelve (12) month period. Supplier shall, no later than fifteen (15) business days after receipt of each such forecast, notify Novartis in writing of any prospective problems of which it is aware that might prevent it from meeting Novartis' forecasted order quantities or estimated delivery dates. Unless Supplier so informs Novartis that it would have problems in meeting Novartis' forecasted requirements, Supplier shall be obligated to deliver during any calendar year, pursuant to purchase orders provided under Section 3.2 of this Agreement, up to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of Novartis' estimated purchases for that calendar year. Supplier shall further use its commercially reasonable best efforts to comply with orders for Products in excess of such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] amount. 3.2 At least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior to the first day of each Calendar Quarter (commencing with the first Calendar Quarter in date on which IMMEDICA orders Novartis desires to have Product from the LICENSOR hereunder)delivered, IMMEDICA Novartis shall prepare and provide the LICENSOR with furnish to Supplier a written forecast of its good faith estimated requirements binding purchase order for Product for each of [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous ForecastProducts which Novartis shall purchase and Supplier shall deliver. The quantities estimated for all subsequent Calendar Quarters of each Forecast to be delivered under any such purchase order shall be nonin full batch-bindingsize quantities only, and for planning purposes only. By way a minimum of example, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.four (4)

Appears in 1 contract

Sources: Supply Agreement (Cima Labs Inc)

Forecasts and Orders. 7.7.1. Not less than [*] prior 4.1 In order that GENSIA SICOR may properly and economically forecast procurement planning with respect to the first day of each Calendar Quarter (Product, PURCHASER shall, commencing with the first Calendar Quarter in which IMMEDICA orders Product from [ * ] immediately following approval of a Cyclosporine Formulation of PURCHASER, submit to GENSIA SICOR within [ * ] business days after the LICENSOR hereunder)beginning of such [ * ] and ---------------------- * Confidential Treatment Requested; confidential portion has been filed separately with the SEC. 4.1.1 A Firm Order may not be canceled, IMMEDICA shall prepare and, following performance by GENSIA SICOR (for itself and provide the LICENSOR with a written forecast through SICOR, as appropriate) of its good faith estimated requirements obligations hereunder with respect to such order, PURCHASER shall be obligated to pay the price for said order as provided in Article 5 hereof. The total amount of each Product ordered by PURCHASER for each delivery in any [ * ] for which an order is required may not be less than [ * ] percent ([ * ]) of [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*PURCHASER's [ * ] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*its [ * ], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA GENSIA SICOR's supply obligation will provide on not extend to more than [ * ] percent ([ * ]) of PURCHASER's [ * ] of its [ * ]. If a country-by-country basis its PURCHASER Product requirement for any quarter exceeds [ * ] of PURCHASER's [ * ], GENSIA SICOR and PURCHASER will discuss in good faith the additional amount, if any, that GENSIA SICOR is willing to supply consistent with its other obligations and PURCHASER will adjust its order accordingly. 4.2 The parties shall meet from time to time to review the estimated number quantities in each forecast and any Firm Order then outstanding and to consult on matters relating to the scheduling of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast manufacture, import and delivery of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied but without prejudice and subject to all identified patients in accordance with the terms of this Agreement. Therapeutic doses obligations of the Product will be supplied on a per patient basis pursuant to the terms of parties set forth in this Agreement. 7.7.2. The LICENSOR shall be required to supply 4.3 Concurrent with execution of this Restated Agreement, Purchaser hereby places Firm Orders (and GENSIA SICOR hereby acknowledges receipt and acceptance of the quantity of Product ordered same on its behalf and by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted SICOR) for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply quantities of the Product via set forth in Exhibit 7 hereto. Notwithstanding the royalty paid foregoing, the parties acknowledge that those Firm Orders set forth in Exhibit 7 with a scheduled delivery date after [ * ], are conditioned upon earlier receipt of AADA approval by IMMEDICA under Section 6.1.3. 7.7.4. During GENSIA SICOR from the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots FDA to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSORat its [ * ] facility.

Appears in 1 contract

Sources: Supply and License Agreement (Sangstat Medical Corp)

Forecasts and Orders. 7.7.1. Not less than [*] prior (a) ABBI agrees to the first day of each Calendar Quarter (commencing with the first Calendar Quarter provide Forecasts, Firm Forecasts and Firm Orders for Products in which IMMEDICA orders Product from the LICENSOR hereunder), IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Product whole batch increments for each of [*] Product by National Drug Code (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients "NDC") in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under procedures set forth in this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product2.4. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR AZ shall use commercially reasonable efforts to supply deliver Products ordered in accordance with timelines set forth in the Firm Orders submitted by ABBI in accordance with this Section 2.4. (b) ABBI shall submit an initial firm order ("Initial Firm Order") upon execution of this Agreement for the entire inventory of the Products in final form and labeled for sale in the Territory then held by AZ anywhere in the world on and as of such excessdate. The LICENSOR Initial Firm Order shall not specify a delivery date that is not [***] from the date of this Agreement. AZ and ABBI agree that, as part of the Initial Firm Order, AZ shall supply to ABBI, not less than a [***], based on the [***] and that, notwithstanding the preceding sentence, such amount of [***] will be delivered on the delivery date specified in the Initial Firm Order or as soon thereafter as is commercially reasonable. The cost of that part of the Initial Firm Order that consists of [***] is included in the Purchase Price (as defined in the Asset Purchase Agreement), and ABBI shall only be obligated to pay for the other Products included in the Initial Firm Order in accordance with Section 5 of this Agreement. (c) Within two business days following the Effective Date, or on such other date as may be agreed to by the Parties in writing, ABBI shall provide to AZ a non-binding forecast of ABBI �s requirements for each Product by NDC for a [***] (a "Forecast"). Such Forecast shall be revised quarterly for a rolling [***] period and delivered to AZ on the first day of each calendar quarter. In addition, for the purposes of AZ's long-term planning, ABBI shall provide a non-binding best estimate of a [***] forecast of its anticipated quarterly requirements for each Product by NDC, which shall be updated on an annual basis on the anniversary of the Effective Date of this Agreement. (d) Within ten (10) business days after the Effective Date of this Agreement, ABBI shall submit to AZ a non-cancelable purchase order (a "Firm Order") for ABBI's orders of Products by NDC to be delivered during the remainder of the current calendar quarter and the following first full calendar quarter. Thereafter, ABBI shall submit a Firm Order no later than the first day of each calendar quarter for all of ABBI's orders of Products by NDC to be delivered in the following calendar quarter. ABBI shall also submit to AZ along with such Firm Order a forecast for the next calendar quarter following the quarter to which the Firm Order applies (a "Firm Forecast"). (See Schedule E attached hereto.) The volume set forth in any Firm Order may not deviate more than [***] for each Product by NDC from the Firm Forecast submitted to AZ by ABBI for such calendar quarter. (e) AZ will respond within [***] of receiving each of ABBI's quarterly rolling Forecast, Firm Forecast and Firm Order, and will either (i) confirm acceptance by AZ of the Forecast, Firm Forecast and Firm Order quantities or (ii) reject the requested quantities and initiate dialogue between the Parties to arrive at mutually acceptable values for the Forecast, Firm Forecast and Firm Order. AZ will use commercially reasonable efforts to accommodate any additional quantity of Products requested by ABBI after the Firm Order has been submitted to AZ, but AZ shall not be liable in any respect for its inability to do so. Notwithstanding anything in this Agreement to the contrary, AZ shall have no obligation to supply more than [***] of the aggregate volume of each Product by NDC for such calendar quarter set forth in any Firm Forecast. Firm Orders may be amended only by mutual agreement of the Parties, in writing. Furthermore, in the event that ABBI submits a Firm Order for a volume that is less than [***] of the volume of any Product(s) by NDC indicated in the Firm Forecast for such calendar quarter, and AZ elects to accept such Firm Order, then AZ shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified utilize excess Components, Materials and Work in accordance with Section 7.7.3. In the event Process as a result of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts such order shortfall for the relevant period provided always that requirements of other Affiliates of AZ or for future periods covered by this Agreement. If AZ is unable to utilize such forecasts were proposed Components, Materials and Work in good faith. The LICENSOR Process, then in such case (and only in such case) AZ shall not give priority of supply have the right to its requirements or its licensees requirements invoice ABBI for the Product outside the Territory. 7.7.3. IMMEDICA shall make cost of all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On Components, Materials and Work in Progress that AZ discarded as a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date result of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3order shortfall. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.

Appears in 1 contract

Sources: Manufacturing Agreement

Forecasts and Orders. 7.7.1. 2.3.1 Not less than [*] twelve (12) months prior to its first purchase of Ingredient for use in the manufacture of Products to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first day twelve (12) month period of Product sales. Within six (6) months prior to its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast for the first twelve (12) month period (by Calendar Quarter), and by the beginning of such twelve (12) month period shall provide GalaGen with an updated forecast for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter (commencing with following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in which IMMEDICA a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders Product from the LICENSOR hereunder), IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Product for each of [*] delivery not later than two (each a “Forecast”)2) months prior to the requested delivery date. IMMEDICA Such purchase orders shall not increase or decrease specify the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-bindingIngredient desired, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties place(s) to which and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients manner and dates by which delivery is to be treated in made. To the Forecast for extent the purposes terms of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses any purchase order or acknowledgment thereof are supplied to all identified patients in accordance inconsistent with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to , the terms of this AgreementAgreement shall control. 7.7.2. 2.3.4 The LICENSOR shall be required to supply the quantity of Product Ingredient ordered by IMMEDICA under this Section 7.7 Wyeth-Ayerst in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date seventy-five percent (75%) of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the last binding [*] forecast provided by Wyeth-Ayerst for such Calendar Quarter. Additionally, GalaGen shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the Forecasts last binding forecast provided by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amount. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture and shipment of the Ingredient in compliance with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 7.7.12.1 hereof, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR such excess amounts of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSORIngredient on commercially reasonable terms.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Galagen Inc)

Forecasts and Orders. 7.7.15.1 During the term of this Agreement, Baxter will submit to Oravax, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. Not less The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than [*] prior to the first tenth (10th) day of each Calendar Quarter calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (commencing 12) month period covered by Baxter Requirements Schedule. 5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period. 5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date. 5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first Calendar Quarter month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule. 5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments. 5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times. 5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder. 5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which IMMEDICA orders B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the LICENSOR hereunder), IMMEDICA Batch or Batches in dispute. The independent laboratory shall prepare act as expert not arbitrator and provide the LICENSOR with a written forecast cost of its good faith estimated requirements for Product for each of [*] (each a “Forecast”)analysis shall be paid by the Party against whom the laboratory findings were made. IMMEDICA Two samples shall not increase or decrease the quantity estimated for [*] of each Forecast be supplied by B▇▇▇▇▇ from the quantity estimated for such periods Batches in the previous Forecastquestion and by Oravax from any samples that it has retained. The quantities estimated for all subsequent Calendar Quarters results of each Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the Parties failure of the Batch in question and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses resolution of the Product. LICENSOR will supply dosimetric doses based on such Forecast dispute between them. 5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product in a manner it reasonably believes most efficient, provided however, it will ensure to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that dosimetric doses are supplied to all identified patients the relevant Batches of Product were Manufactured in accordance with the terms Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of this Agreementsuch Batches. Therapeutic doses Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product will be supplied on a per patient basis pursuant to the terms Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32. 5.10 If, in any calendar year of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent ForecastAgreement beginning 2005, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 Manufacturing Fees received by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is Oravax are less than the quantity specified in sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the binding [*] “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the Forecasts provided under Section 7.7.1, IMMEDICA difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots pay to manufacture Product that was not subsequently ordered, subject to Oravax the provision by LICENSOR of appropoirate evidence amount of such costs and to the extent that difference within thirty (30) days of receipt of such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSORnotice.

Appears in 1 contract

Sources: Contract Manufacturing Agreement (Acambis PLC)

Forecasts and Orders. 7.7.1. Not less than [5.3.1 At least *] ** days prior to the first day of each Calendar Quarter (commencing with Semiannual Period during the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder)Term, IMMEDICA ViroPharma shall prepare and provide the LICENSOR with deliver to Sanquin a written written, good faith *** month forecast of its good faith estimated requirements for the volume of ViroPharma Product for each of [that ViroPharma then anticipates will be required to be produced and delivered to ViroPharma during that *] ** month period (each a the Semiannual Forecast”). IMMEDICA shall not increase or decrease The first *** months of the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Semiannual Forecast shall be non-bindingcontain ViroPharma’s volume requirements for ViroPharma Product by month (the “Firm Portion”), and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] which shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses The remaining *** months of the ProductSemiannual Forecast shall contain ViroPharma’s non-binding then-anticipated volume requirements for ViroPharma Product by calendar *** only. 5.3.2 As part of each Firm Portion, ViroPharma shall place firm orders with Sanquin, setting forth Units (or any other measurement agreeable to both Parties), the various countries such Units shall be delivered to, anticipated delivery dates and shipping instructions with respect to each shipment of ViroPharma Product for delivery. LICENSOR will Actual supply dosimetric doses based on such Forecast of the Product and shipment shall then take place pursuant to purchase orders which are in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied form and according to all identified patients in accordance a working procedure mutually acceptable to ViroPharma and Sanquin and consistent with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR 5.3.3 Sanquin shall not be required obligated to supply accept any Firm Portion to the extent the quantity of ViroPharma Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up pursuant to such Firm Portion exceeds ***% of the quantity of ViroPharma Product that was anticipated to be ordered for the same Semiannual Period according to the quantity forecasted for immediately preceding Semiannual Forecast. Notwithstanding the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecastforegoing limitations, the LICENSOR Sanquin shall use commercially reasonable efforts to supply fill such excess. The LICENSOR order for such excess quantities from available supplies, and Sanquin shall use commercially reasonable efforts to meet IMMEDICAnotify ViroPharma within *** Business Days after receipt of an order of Sanquin’s delivery ability to fill any amounts of such order in excess of the quantities that Sanquin is obligated to supply. ViroPharma shall notify Sanquin as soon as possible of an increase in ViroPharma’s requirements specified for ViroPharma Product materially in excess of the limits set forth herein. In any event the quantity of ViroPharma Product that Sanquin is obligated to supply to ViroPharma under this Agreement shall in any year not exceed the maximum amount as established for the ViroPharma Portion in the Capacity Schedule for such year. 5.3.4 In the event that ViroPharma submits any Firm Portion for ViroPharma Product for less than ***% of the quantity of ViroPharma Product anticipated to be ordered for the same Semiannual Period according to immediately preceding Semiannual Forecast, Sanquin nevertheless shall have the right to supply and ship to ViroPharma (in accordance with Section 7.7.3the shipping instructions most recently supplied by ViroPharma) ***% of the quantity of ViroPharma Product set forth in the immediately preceding Semiannual Forecast for such Semiannual Period. ViroPharma shall notify Sanquin as soon as possible of a decrease in ViroPharma’s requirements for ViroPharma Product materially below the limits set forth herein. In the event of such a shortfalldecrease, the LICENSOR Sanquin shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICAcommercially reasonable efforts, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which but shall not be less than [*] from after required, to reduce accordingly. 5.3.5 Notwithstanding the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreementforegoing, the LICENSOR shall be paid for its supply Parties may mutually agree to a forecasting and ordering procedure in advance of the Product via the royalty paid by IMMEDICA under Section 6.1.3a Launch. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.

Appears in 1 contract

Sources: Manufacturing and Distribution Agreement (Viropharma Inc)

Forecasts and Orders. 7.7.1. Not less than [*] prior to the first day of each Calendar Quarter (commencing with the first Calendar Quarter in which IMMEDICA orders Unlabeled Product from the LICENSOR hereunder), IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Unlabeled Product for each of the [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast]. The quantities estimated for all subsequent Calendar Quarters quarterly periods of each Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*]] IMMEDICA shall, in good faith, seek to limit its orders such that in any calendar year, it submits its entire year’s demand across [*] purchase orders. 7.7.2. IMMEDICA shall be required to purchase, and the LICENSOR shall be required to supply, [*] shall be binding on of the Parties and quantity of Unlabeled Product forecast in the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreementeach Forecast. 7.7.27.7.3. The LICENSOR shall be required to supply the quantity of Unlabeled Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the ProductForecast. If IMMEDICA’s orders in any Calendar Quarter exceed exceeds the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts Commercially Reasonable Efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts Commercially Reasonable Efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.37.7.4. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Unlabeled Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period period, provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.37.7.4. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit Each such purchase order shall be in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Unlabeled Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basisIn addition, IMMEDICA will specify the extent to which any Unlabeled Product should be supplied at a [*], in order to extend the shelf-life of the Product to [*] (the “[*]”). In the event that any [*] is ordered, it shall inform be prioritized by the LICENSOR as soon as practical of identified potential patient and when such that the first order the LICENSOR delivers after a dosimetric dose of Product new manufacturing run has been administeredcompleted shall be the [*] ordered by IMMEDICA. Except as otherwise Upon receipt of a purchase order reflecting the requirements of this Section 7.7.4 by the LICENSOR, such purchase order shall be binding on both Parties. Notwithstanding the foregoing, if IMMEDICA places an order for delivery of Unlabeled Product and the requested delivery date is [*] after the last manufacturing run has been completed by the LICENSOR, then the LICENSOR may notify IMMEDICA in writing that such Unlabeled Product may not be able to comply with the minimum shelf-life requirements set out in Section 7.9.1, and what the remaining shelf-life of such Unlabeled Product would be (“Short-Dated Product”). In such circumstances, if IMMEDICA chooses to proceed with such order, it shall not be a breach of Section 7.9.1 if the Unlabeled Product delivered by LICENSOR to IMMEDICA does not have the minimum shelf-life requirements, provided it has the remaining shelf-life advised by the LICENSOR at the time that IMMEIDCA chooses to proceed with the order. If IMMEDICA chooses not to proceed with such order, then such purchase order shall automatically be cancelled and shall not be binding on the Parties. No additional terms of any such purchase order shall be binding on the LICENSOR and are expressly provided in rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term terms and conditions of this AgreementAgreement shall prevail. IMMEDICA shall, in good faith, coordinate with LICENSOR to minimize placing orders with a requested delivery date after the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding first [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSORrun.

Appears in 1 contract

Sources: License and Supply Agreement (Aeglea BioTherapeutics, Inc.)

Forecasts and Orders. 7.7.12.2.1 On the Effective Date of this Agreement, PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will order or direct the Designee(s) to order from SELLER during the remainder of the current calendar year (the “Initial Annual Forecast”). Not less later than [*] prior November 30 of each calendar year during the Term of this Agreement, PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will order or direct the Designee(s) to order from SELLER during the next subsequent calendar year (each, an “Annual Forecast”). The Annual Forecast shall be used to establish the per unit and per kilogram pricing for the Martek Products purchased during the relevant calendar year in accordance with Section 2.3.1 and Exhibit A attached hereto; provided that, for the remainder of calendar year 2006, the per kilogram pricing to be used, subject to the first day year-end adjustment pursuant to Section 2.3.1, shall be * per kilogram, notwithstanding the Initial Annual Forecast. In addition to the foregoing, one (1) month before the commencement of each Calendar Quarter (commencing with calendar quarter during the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder)Term of this Agreement, IMMEDICA PURCHASER shall prepare and provide the LICENSOR SELLER with a written forecast (a “Rolling Forecast”) of its good faith estimated PURCHASER’s requirements for the Martek Product for each of [*] the succeeding four (each 4) quarters, specifying quantities and requested delivery dates. These forecasts will be PURCHASER’s good-faith, best estimate of requirements and should not be considered a “Forecast”). IMMEDICA shall not increase or decrease firm commitment. 2.2.2 PURCHASER expressly acknowledges that available supplies of the quantity estimated for [*] of each Forecast from the quantity estimated for such periods Martek Product have been in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-bindingpast, and for planning purposes only. By way of exampleand, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients may from time to be treated time in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Productfuture, be insufficient to meet current demand. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficientNevertheless, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR SELLER shall use commercially reasonable efforts to have available for shipment to PURCHASER or to a Designee for PURCHASER’s account such quantities of the Martek Product as PURCHASER forecasts in good faith pursuant to Section 2.2.1 above and any additional quantities which PURCHASER may reasonably request. In case for any reason SELLER cannot or does not supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In quantities of the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed Martek Products as are forecasted in good faithfaith by PURCHASER pursuant to Section 2.2.1 to PURCHASER, PURCHASER shall be allowed to use an alternative supplier for quantities of Omega-3 and Omega-6 long-chain polyunsaturated fatty acids equal to those quantities of Martek Products that were ordered by PURCHASER pursuant to a Purchase Order and not delivered by SELLER. 2.2.3 PURCHASER shall issue and/or shall direct the Designee(s) to issue formal purchase orders (“Purchase Orders”) at least sixty (60) but no more than ninety (90) days in advance of the date on which PURCHASER or the Designee requests that SELLER ship the Martek Product. The LICENSOR SELLER shall accept or reject any such Purchase Order within five (5) business days of receipt, provided that SELLER shall not give priority of supply to its requirements or its licensees requirements reject any Purchase Order for any quantities within the Product outside the Territorymost recent forecast. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 2.2.4 Purchase Orders which have been accepted by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR SELLER shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA considered as firm and binding orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, (subject to the provision provisions of Section 2.2.2 above) and shall only be canceled or amended by LICENSOR mutual written agreement of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSORparties. * CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Appears in 1 contract

Sources: Supply Agreement (Mead Johnson Nutrition CO)

Forecasts and Orders. 7.7.12.1 LD shall provide M▇▇▇ with a twelve (12) month forecast estimating the number of Products, according to LD's market projections, that LD anticipates it shall purchase from M▇▇▇ during the upcoming twelve (12) month period. Not less than [*] prior LD shall thereafter update the rolling forecast on a monthly basis for the then-upcoming twelve-month period ("Current Rolling Forecast"). M▇▇▇ shall use the Current Rolling Forecast to procure materials and plan manufacturing capacity. LD shall purchase 100% of the Product requirements, and M▇▇▇ agrees to use all reasonable efforts to ship I 00% of the Product requirements, indicated in the first day two (2) months of each Calendar Quarter (commencing with the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder), IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Product for each of [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous any then Current Rolling Forecast. For the second two (2) months of any then Current Rolling Forecast, LD shall commit to purchase a minimum of 70%, and M▇▇▇ shall commit to use all reasonable efforts to supply up to a maximum 130%, of the forecasted amount of Product. For the third two (2) months of any then Current Rolling Forecast, LD shall commit to purchase a minimum of 50%, and M▇▇▇ shall commit to use all reasonable efforts to supply up to a maximum 150%, of the forecasted amount of Product. The quantities estimated for all subsequent Calendar Quarters final six (6) months of each any then Current Rolling Forecast shall be non-binding, and for planning purposes only. By way of examplePurchase Orders spelling out specific quantities, if IMMEDICA issues a forecast on [*], [*] delivery dates and destinations shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients issued in accordance with this Agreement, and shall be incorporated into, and be a material part of this Agreement All delivery schedules are by mutual agreement and subject to the capacity of available Tooling. M▇▇▇ will notify LD of the Tooling capacity limitations. Long lead time components will be covered by a separate authorization-to-buy from LD. 2.2 The terms of this AgreementAgreement shall govern orders for Products. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the Except as specifically provided in Section 2.1 above, pre-printed or other terms of this Agreementand conditions contained in LD's purchase orders shall not apply unless agreed by M▇▇▇ in writing. 7.7.2. The LICENSOR shall be required 2.3 M▇▇▇ agrees to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use all commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts fill all Purchase Orders for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases Products placed by LD under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, if within the LICENSOR shall be paid for its supply of Current Rolling Forecast and purchase order lead time as agreed upon by the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreementparties, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.notify LD within five

Appears in 1 contract

Sources: Manufacturing Agreement (Turnpoint Medical Devices, Inc.)

Forecasts and Orders. 7.7.1(a) Starting on the Effective Date and prior to the 15th day of each new calendar quarter during the Initial Term, FHLR or its Affiliates shall furnish to 454 a rolling Forecast in quarterly increments indicating, by calendar quarter, the quantities of the Licensed Products that FHLR and its Affiliates intend to order during each calendar quarter of the twelve (12) month period starting with the first day of the succeeding calendar quarter. Not The amounts set forth for the first calendar quarter included in such Forecast shall constitute a binding commitment upon FHLR and its Affiliates to purchase the Licensed Product quantities in the Forecast for such period, pursuant to purchase orders which shall be submitted by FHLR or its Affiliates to 454 in accordance with Section 3.5(c). The binding Forecast for any such calendar quarter shall be no less than [******************] prior to the first day of each Calendar Quarter (commencing with the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder), IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Product for each of no more than [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*******************************] of each the previous non-binding Forecast from the quantity estimated for such periods in calendar quarter. During the first Contract Year the binding Forecast for any such calendar quarter shall be no less than [**************] and no more than [******************* ************] of the previous Forecastnon-binding forecast for such calendar quarter. The quantities estimated for all subsequent Calendar Quarters remaining nine (9) months of each such Forecast shall merely represent reasonable estimates for planning purposes only and will be good faith Forecasts but, however, shall not obligate FHLR or its Affiliates to purchase the Licensed Product quantities set forth therein. (b) The estimated initial rolling Forecast for Licensed Products added to Exhibit 2 according to Section 2.7 after the Effective Date shall be agreed upon in writing at DO milestone until the above described rolling forecasting process begins and shall be non-binding. Thereafter, Forecasts for such added Licensed Products shall be included in each Forecast to be provided pursuant to Section 3.5(a). (c) FHLR or its Affiliates shall place each purchase order with 454 for the Licensed Products to be delivered hereunder in writing. Each such purchase order shall constitute a binding obligation upon FHLR and its Affiliates and shall be confirmed by 454 within two (2) weeks from receipt of the purchase order, such confirmation to include information on the expected delivery date. Notwithstanding the foregoing, 454 shall not be obligated to confirm purchase orders that exceed the binding forecast for planning purposes onlythe relevant calendar quarter or that are received after the expiration or termination of the Initial Term. By way 454 shall use best efforts to deliver within four (4) weeks from the receipt of exampleeach purchase order such quantity of Licensed Products as is set forth in the binding Forecast for the quarter. For Excess Quantity orders, if IMMEDICA issues a forecast 454 shall use its commercially reasonable efforts to meet the four (4) weeks delivery date for such purchase orders and shall reasonably adapt its production capacity accordingly. 454 may use the Safety Stock of the Licensed Products to be maintained pursuant to Section 3.7 to meet Excess Quantity orders. (d) During the Initial Term, FHLR or its Affiliates may order spare parts from 454 from time to time with prices as specified in Exhibit 7 and as further set out below. Exhibit 7 shall be amended annually by the Joint Steering Committee as proposed by the Operations Steering Committee based on the criteria set forth below. 454 shall deliver such spare parts to FHLR or its Affiliates as soon as reasonably available, but in any event within thirty (30) days of the relevant purchase order. Any such spare parts which are to be used by FHLR or its Affiliates for technical service during the warranty period shall be provided free of charge to FHLR or its Affiliates. For any such spare parts which are to be used in connection with technical service which is to occur after the warranty period, spare part prices shall be based on the Instrument Transfer Price using [***************************************** ************************************], [*] as initially provided for Rev. 1.0 in Exhibit 7. FHLR shall provide 454 with any information reasonably requested by 454 to confirm any amounts due to 454 hereunder based on the use of spare parts and such information shall be binding on the Parties and the forecasts for [*] shall subject to audit as provided in Article 4. (e) FHLR’s or its Affiliates’ purchase orders may not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the modify any terms of this AgreementAgreement or add any terms not set forth herein. Therapeutic doses Any such additional terms or modifications shall have no effect. In the event there is any confusion as to the obligations of the Parties regarding a particular Licensed Product will purchase order, the Parties agree that the resolution of such issue shall be supplied on a per patient basis pursuant to controlled solely by the terms of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.

Appears in 1 contract

Sources: License, Supply and Distribution Agreement (Curagen Corp)

Forecasts and Orders. 7.7.12.2.1 On the Effective Date of this Agreement, PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will order or direct the Designee(s) to order from SELLER during the remainder of the current calendar year (the “Initial Annual Forecast”). Not less later than [*] prior November 30 of each calendar year during the Term of this Agreement, PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will order or direct the Designee(s) to * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the first day Securities and Exchange Commission. order from SELLER during the next subsequent calendar year (each, an “Annual Forecast”). The Annual Forecast shall be used to establish the per unit and per kilogram pricing for the Martek Products purchased during the relevant calendar year in accordance with Section 2.3.1 and Exhibit A attached hereto; provided that, for the remainder of calendar year 2006, the per kilogram pricing to be used, subject to the year-end adjustment pursuant to Section 2.3.1, shall be * per kilogram, notwithstanding the Initial Annual Forecast. In addition to the foregoing, one (1) month before the commencement of each Calendar Quarter (commencing with calendar quarter during the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder)Term of this Agreement, IMMEDICA PURCHASER shall prepare and provide the LICENSOR SELLER with a written forecast (a “Rolling Forecast”) of its good faith estimated PURCHASER’s requirements for the Martek Product for each of [*] the succeeding four (each 4) quarters, specifying quantities and requested delivery dates. These forecasts will be PURCHASER’s good-faith, best estimate of requirements and should not be considered a “Forecast”). IMMEDICA shall not increase or decrease firm commitment. 2.2.2 PURCHASER expressly acknowledges that available supplies of the quantity estimated for [*] of each Forecast from the quantity estimated for such periods Martek Product have been in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-bindingpast, and for planning purposes only. By way of exampleand, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients may from time to be treated time in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Productfuture, be insufficient to meet current demand. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficientNevertheless, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR shall be required to supply the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up to the quantity forecasted for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR SELLER shall use commercially reasonable efforts to have available for shipment to PURCHASER or to a Designee for PURCHASER’s account such quantities of the Martek Product as PURCHASER forecasts in good faith pursuant to Section 2.2.1 above and any additional quantities which PURCHASER may reasonably request. In case for any reason SELLER cannot or does not supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In quantities of the event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed Martek Products as are forecasted in good faithfaith by PURCHASER pursuant to Section 2.2.1 to PURCHASER, PURCHASER shall be allowed to use an alternative supplier for quantities of Omega-3 and Omega-6 long-chain polyunsaturated fatty acids equal to those quantities of Martek Products that were ordered by PURCHASER pursuant to a Purchase Order and not delivered by SELLER. 2.2.3 PURCHASER shall issue and/or shall direct the Designee(s) to issue formal purchase orders (“Purchase Orders”) at least sixty (60) but no more than ninety (90) days in advance of the date on which PURCHASER or the Designee requests that SELLER ship the Martek Product. The LICENSOR SELLER shall accept or reject any such Purchase Order within five (5) business days of receipt, provided that SELLER shall not give priority of supply to its requirements or its licensees requirements reject any Purchase Order for any quantities within the Product outside the Territorymost recent forecast. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 2.2.4 Purchase Orders which have been accepted by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR SELLER shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA considered as firm and binding orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, (subject to the provision provisions of Section 2.2.2 above) and shall only be canceled or amended by LICENSOR mutual written agreement of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSORparties.

Appears in 1 contract

Sources: Supply Agreement (Martek Biosciences Corp)

Forecasts and Orders. 7.7.1The initial forecast for the Products will be a 24-month non-binding forecast of demand for each Product after the Effective Date for capacity planning purposes, and is attached as Exhibit D. Purchaser shall submit to Seller a purchase order for the initial six (6) months of the initial forecast within five (5) days of the Start Date of this Agreement. Not less than [*] prior to Within five (5) days after the first day beginning of each Calendar Quarter (commencing with calendar quarter during the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder)Term of this Agreement, IMMEDICA Purchaser shall prepare and provide the LICENSOR Seller with a written rolling forecast of its good faith estimated Purchaser’s expected requirements for Product the Products during the following twelve (12) months. The first six (6) months of each such forecast shall be binding; and the amounts set forth for each of [*] the following two (each 2) calendar quarters shall constitute a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-binding, and good faith estimate of the Product requirements of Purchaser for such period for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.2. The LICENSOR Seller shall be required to supply manufacture and deliver to Purchaser such quantities of Products as Purchaser orders in any calendar quarter up to 125% of the quantity forecast for such calendar quarter in the immediately preceding binding forecast. Seller shall use reasonable commercial efforts to manufacture, or have manufactured, and deliver to Purchaser any quantities of Product ordered by IMMEDICA under this Section 7.7 Purchaser orders in any Calendar Quarter up to excess of 125% of the quantity forecasted for the [*] such calendar quarter, but shall be under no obligation to provide to Purchaser any quantities of the most recent Forecast in a manner that is reasonably practical given the nature Product which exceed 125% of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] such calendar quarter. If Seller becomes aware of the most recent Forecast, the LICENSOR shall use commercially reasonable efforts any circumstances that may cause Seller to default on its obligation to deliver such quantities of Product as Purchaser orders or to fail to supply such excess. The LICENSOR shall use commercially reasonable efforts to meet IMMEDICA’s delivery requirements specified quantities of Product in accordance with Section 7.7.3Purchaser’s forecasts for any calendar quarter, Seller shall give Purchaser prompt written notice describing such circumstances, together with a proposed course of action to remedy such failure. In the event of a shortfallsignificant change in market conditions, significant new competitive factors and/or new key customer demands, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts parties agree to apportion Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed negotiate in good faith. The LICENSOR shall not give priority of supply faith on appropriate changes to its requirements or its licensees requirements for the Product outside the Territorysuch forecasts. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.

Appears in 1 contract

Sources: Supply Agreement (Savient Pharmaceuticals Inc)

Forecasts and Orders. 7.7.14.4.1. Not less than [At least *] ** days prior to the first day of each Calendar Quarter (commencing with Semiannual Period during the first Calendar Quarter in which IMMEDICA orders Product from the LICENSOR hereunder)Term, IMMEDICA VBI shall prepare and provide the LICENSOR with deliver to Sanquin a written written, good faith *** month forecast of its good faith estimated requirements for the volume of Product for each of [that VBI then anticipates will be required to be produced and delivered to VBI during that *] ** month period (each a the Semiannual Forecast”). IMMEDICA shall not increase or decrease The first *** months of the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Semiannual Forecast shall be non-bindingcontain VBI’s volume requirements for Product by month (the “Firm Portion”), and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] which shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses The remaining *** months of the ProductSemiannual Forecast shall contain VBI’s non-binding then-anticipated volume requirements for Product by calendar *** only. 4.4.2. LICENSOR will As part of each Firm Portion, VBI shall place firm orders with Sanquin, setting forth Units (or any other measurement agreeable to both Parties), the various countries such Units shall be delivered to, anticipated delivery dates and shipping instructions with respect to each shipment of Product for delivery. Actual supply dosimetric doses based on such Forecast of the Product and shipment shall then take place pursuant to purchase orders which are in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied form and according to all identified patients in accordance a working procedure mutually acceptable to VBI and Sanquin and consistent with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement. 7.7.24.4.3. The LICENSOR Sanquin shall not be required obligated to supply accept any Firm Portion to the extent the quantity of Product ordered by IMMEDICA under this Section 7.7 in any Calendar Quarter up pursuant to such Firm Portion exceeds ***% of the quantity of Product that was anticipated to be ordered for the same Semiannual Period according to the quantity forecasted for immediately preceding Semiannual Forecast. Notwithstanding the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecastforegoing limitations, the LICENSOR Sanquin shall use commercially reasonable efforts to supply fill such excess. The LICENSOR order for such excess quantities from available supplies, and Sanquin shall use commercially reasonable efforts to meet IMMEDICAnotify VBI within *** days after receipt of an order of Sanquin’s delivery ability to fill any amounts of such order in excess of the quantities that Sanquin is obligated to supply. VBI shall notify Sanquin as soon as possible of an increase in VBI’s requirements specified for Product materially in excess of the limits set forth herein. In any event the quantity of Product required to be supplied by Sanquin to VBI under this Agreement shall in any calendar year not exceed the maximum amount as established for the VBI Portion in the Capacity Schedule for such year unless agreed otherwise between the Parties. 4.4.4. In the event that VBI submits any Firm Portion for Product for less than the ***% of the quantity of Product that was anticipated to be ordered for the same Semiannual Period according to the immediately preceding Semiannual Forecast, Sanquin nevertheless shall have the right to supply and ship to VBI (in accordance with Section 7.7.3the shipping instructions most recently supplied by VBI) ***% of the quantity of Product set forth in the immediately preceding Semiannual Forecast for such Semiannual Period. VBI shall notify Sanquin as soon as possible of a decrease in VBI’s requirements for Product materially below the limits set forth herein. In the event of such a shortfalldecrease, the LICENSOR Sanquin shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Product among IMMEDICAcommercially reasonable efforts, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, and shall specify the quantity of Product ordered, the place of delivery and the required delivery date therefor, which but shall not be less than [*] from after required, to reduce accordingly. 4.4.5. Notwithstanding the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreementforegoing, the LICENSOR shall be paid for its supply Parties may mutually agree to a forecasting and ordering procedure in advance of the Product via the royalty paid by IMMEDICA under Section 6.1.3any Launch. 7.7.4. During the Term of this Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.

Appears in 1 contract

Sources: Distribution and Manufacturing Services Agreement (Viropharma Inc)

Forecasts and Orders. 7.7.1. Not less than [*] prior (a) Prior to the first day beginning of each Calendar Quarter (commencing calendar month during the term of this Agreement, Haemacure shall give Immuno a forecast of the orders of Product that Haemacure expects to place with Immuno during each of the first Calendar Quarter in which IMMEDICA next 12 months, using the scheduling system employed by Immuno. The forecast for the next six months shall constitute firm orders. If the orders Product vary from the LICENSOR hereunder), IMMEDICA shall prepare and provide the LICENSOR with a written forecast of its good faith estimated requirements for Product for each of [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*] of each Forecast from the quantity estimated for such periods in the previous Forecast. The quantities estimated for all subsequent Calendar Quarters of each Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] the six months by more than 10%, Immuno shall use reasonable efforts to fill such orders but shall not be binding obligated to fill any orders in excess of 10% of the forecasted amount. The forecast for the first 12 month period beginning on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number date of patients Immuno FDA Approval shall be delivered to be treated in Immuno by Haemacure within 30 days after the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms date of this Agreement. 7.7.2(b) Subject to the provisions of Sections 3(d) and 10 below, Immuno agrees to supply Product pursuant to Haemacure's written orders. Orders shall specify quantities ordered, delivery dates, and delivery and shipping instructions. The LICENSOR obligations and rights of the parties shall be required to supply governed by the quantity terms and conditions of Product ordered this Agreement, and none of the general terms set forth on any such purchase order form used by IMMEDICA under this Section 7.7 in Haemacure or any Calendar Quarter up purchase order acknowledgment form used by Immuno shall be applicable, to the quantity forecasted extent inconsistent with the terms hereof. (c) The parties shall cooperate in good faith in providing other, longer range forecasts which shall be useful in budget planning for the [*] of the most recent Forecast in a manner that is reasonably practical given the nature of the Product. If IMMEDICA’s orders in any Calendar Quarter exceed the quantity forecasted for the [*] of the most recent Forecast, the LICENSOR shall parties. (d) The parties will use all commercially reasonable efforts to supply such excess. The LICENSOR shall use commercially reasonable efforts allocate Product fairly and equitably to meet IMMEDICA’s delivery requirements specified in accordance with Section 7.7.3. In Haemacure, based on the event relative potential sales of a shortfall, the LICENSOR shall promptly inform IMMEDICA Tisseel and use Commercially Reasonable Efforts to apportion Product among IMMEDICA, the LICENSOR, Tisseel-derived products by Immuno inside and its other customers on a [*] according to their respective forecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory. 7.7.3. IMMEDICA shall make all purchases under this Section 7.7 by submitting firm purchase orders to the LICENSOR. On a [*] basis, IMMEDICA shall submit such purchase order in writing in a form reasonably acceptable to the LICENSOR, Territory and shall specify the quantity of Product orderedby Haemacure in the Territory, the place of delivery and the required delivery date therefor, which shall not be less than [*] from after the date of such purchase order. On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of identified potential patient and when a dosimetric dose of Product has been administered. Except as otherwise expressly provided in this Agreement, the LICENSOR that Haemacure shall be paid for its supply allocated the lesser of 50% of the Product via the royalty paid by IMMEDICA under Section 6.1.3. 7.7.4. During the Term of this Agreement, so allocated to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall refund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 Territory or such manufacturing slots cannot be reused or cancelled by LICENSORits firm orders.

Appears in 1 contract

Sources: Manufacturing Agreement (Haemacure Corp)