Forecasts Orders. 6.3.1 Acologix shall provide Toray with an estimate of the volume of Products to be ordered in the first four quarters of commercial supply of Products (i.e. the four consecutive calendar quarters beginning with the calendar quarter in which Acologix makes its first commercial sale) (the “First Year”) within [***] after (i) Acologix or its Sublicensee files the first NDA for a Product in North America; or (ii) Acologix files the first MAA for a Product in Europe if Acologix is assigned responsibility by the JDCC for Commercialization of Injection Products in Europe, whichever is earlier. Acologix shall have the right to update that First Year forecast [***]. 6.3.2 Acologix shall provide its first firm order by no later than [***] before the anticipated first Sales of the Product. Upon placement of the first firm order by Acologix, the Parties shall be bound to the then-current forecast for the First Year (the “First Year Forecast”) as set forth in this Section 6.3.2, provided that the First Year Forecast shall not take into account any update provided by Acologix after the date that is [***] prior to placement of the first firm order. Over the course of the First Year, Acologix shall be obligated to place firm orders for no less than [***] of the First Year Forecast. Toray shall be obligated to accept and fulfill any firm orders placed by Acologix to the extent the total of such firm orders in the First Year do not exceed [***] of the First Year Forecast, and Toray shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amount. 6.3.3 Beginning with the calendar quarter in which Acologix places its first firm order, within [***] after the end of each calendar quarter Acologix shall provide a rolling four quarter estimate of the volume of Products to be order by Acologix (the most recent estimate, the “Annual Forecast”). The Parties shall determine appropriate procedures and binding terms and conditions related to the Annual Forecast in the Supply Agreements.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Acologix, Inc.), Collaboration and License Agreement (Acologix, Inc.)
Forecasts Orders. 6.3.1 Acologix (i) LMI shall provide Toray with an estimate of send to HSL a **** (****) month forecast (the “Initial Forecast”) for the volume of Products Product which LMI expects to be ordered in the first four quarters of commercial supply of Products (i.e. the four consecutive calendar quarters beginning with the calendar quarter in which Acologix makes its first commercial sale) (the “First Year”) within [have delivered from HSL during such ***] *-month period. LMI shall provide the Initial Forecast for Product to HSL within **** (****) days after (i) Acologix or its Sublicensee files HSL is approved as a supplier of Product under the Product NDA. LMI shall thereafter update such forecast at least **** prior to the first NDA business day of each calendar month thereafter (a “Subsequent Forecast”, and together with the Initial Forecast, a “Forecast”), providing HSL with a rolling **** (****) month forecast for Product. Each Forecast shall include an estimated number of Batches for each month during the ****-month period covered by such Forecast. Amounts set forth in a Forecast are estimates, to be used for planning purposes only, and Forecasts shall not constitute binding purchase orders, except that the first **** (****) months of each Forecast shall be binding upon LMI and LMI shall place purchase orders corresponding to the binding portion of such Forecast. In the event LMI does not place purchase orders against the binding portion of a Forecast, HSL may (but shall not be required to) deem such binding Forecast as a purchase order for Product covered by the binding portion of the Forecast. HSL will use all commercially reasonable efforts to accommodate any changes in North America; or quantities of Product ordered by LMI.
(ii) Acologix files Subject to the first MAA terms of this Agreement (including, but not limited to, Sections 5.1, 5.5 and 9.5), LMI agrees that, during each calendar year of this Agreement (with a pro-rata adjustment as applicable for a Product in Europe if Acologix is assigned responsibility by the JDCC any portion thereof), it shall place orders with HSL for Commercialization of Injection Products in Europe, whichever is earlier. Acologix shall have the right to update that First Year forecast [at least ***].
6.3.2 Acologix shall provide its first firm order by no later than [* percent (***] before *%) of its aggregate requirements for Product in the anticipated first Sales jurisdictions in the Territory where HSL is approved as a qualified supplier of the Product. Upon placement This requirement shall commence on a country-by-country basis in the Territory on the **** (****) day after HSL is qualified as a supplier of the first firm Product under the applicable regulatory approval in such country and end on the earlier of the termination or expiration of this Agreement. In addition, this requirement is expressly conditioned upon reasonably acceptable notice of HSL’s approval as a supplier of Product for a jurisdiction in the Territory. During any period in which HSL’s manufacture for a jurisdiction is not in compliance with cGMPs for such jurisdiction and/or not in material compliance with the applicable laws of such jurisdiction, LMI’s requirements for such jurisdiction shall not be included in the aggregate requirements of LMI for purposes of computing the amount of Product required to be ordered from HSL. In the event HSL cannot fill a purchase order by Acologixissued in accordance with a Forecast, the quantities in such purchase order shall be deemed to have been ordered from HSL for purposes of LMI’s requirements for placing orders pursuant to this section. For purposes of clarity, the Parties shall be bound to acknowledge that the then-current forecast aggregate requirements for the First Year (the “First Year Forecast”) as Product set forth above include both LMI’s and its Affiliates’ requirements for such Product and that HSL’s rights set forth in Section 2.2(a)(iv) of this Section 6.3.2Agreement extend to the books and records of both LMI and its Affiliates.
(iii) Without limiting HSL’s remedies in the event of a breach of the preceding paragraph, provided that in the First Year Forecast shall not take into account any update provided event LMI fails to order the requirements set forth above the Parties may discuss and agree on making HSL whole (including recovery of lost profits), such as by Acologix after way of example through one or more of the date that is [following mechanisms: ***] *.
(iv) LMI shall maintain accurate and complete books and records of its purchases for the jurisdictions in the Territory where HSL is a qualified supplier of the Product as to enable LMI and its Affiliates to verify their purchases of Product in such jurisdictions. Upon reasonable advance written notice and subject to a confidentiality agreement reasonably acceptable to LMI, at the written request of HSL, LMI shall permit an independent certified public accounting firm or consultant selected by HSL and reasonably acceptable to LMI to have access during normal business hours to such of the records of LMI as may be reasonably necessary to verify the accuracy of LMI’s orders for the immediately preceding calendar year.
(v) LMI will establish performance parameters and weightings for the Product to determine a performance score (“Score”) and communicate the same to HSL prior to placement each calendar year. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the first firm order. Over Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the course immediately preceding calendar year or portion thereof (each a “Scoring Year”) HSL achieved the highest Score with respect to the Product among LMI’s qualified suppliers of such Product, then the First Year, Acologix minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall be obligated to place firm orders for no less than [increase from ***] of the First Year Forecast. Toray shall be obligated to accept and fulfill any firm orders placed by Acologix to the extent the total of such firm orders in the First Year do not exceed [* percent (***] of the First Year Forecast, and Toray shall use best efforts *%) to fulfill any amounts ordered by Acologix in excess of such amount.
6.3.3 Beginning with the calendar quarter in which Acologix places its first firm order, within [***] * percent (****%) for the then current Subject Year, as if **** percent (****%) was set forth in Section 2.2(a)(ii). Within **** (****) days after the end of each calendar quarter Acologix Scoring Year, LMI shall provide send to HSL a rolling four quarter estimate written notice of HSL’s Score for such Scoring Year (including the calculation of same) and a statement as to whether HSL had the highest Score. In the event HSL is determined not to have the highest Score, then, within **** (****) days after the end of such Scoring Year, upon reasonable advance written notice and subject to a confidentiality agreement reasonably acceptable to LMI, LMI shall permit an independent industry expert selected by HSL and reasonably acceptable to LMI to confirm LMI’s assessment of the volume highest Score for the immediately preceding Scoring Year, provided that such expert’s report to HSL shall be limited to an indication from such expert that LMI is “in compliance” or “out of Products to be order by Acologix (compliance” with the most recent estimate, the “Annual Forecast”). The Parties shall determine appropriate procedures and binding terms and conditions related to the Annual Forecast in the Supply Agreementsmethodology for such Scoring Year.
Appears in 2 contracts
Samples: Manufacturing and Supply Agreement (Lantheus Medical Imaging, Inc.), Manufacturing and Supply Agreement (Lantheus Medical Imaging, Inc.)
Forecasts Orders. 6.3.1 Acologix shall provide Toray 3.1 Initial Forecast for Products. Prior to the Effective Date, Manufacturer provided Confidential Information indicated by [***] has been omitted from this filing and filed separately with an estimate the Securities Exchange Commission. Purchaser with Seller’s forecast of the volume of Products to be ordered finished Product for Distribution in the first four quarters of commercial supply of Products (i.e. United States during the four consecutive calendar quarters [***] period beginning with on the calendar quarter in which Acologix makes its first commercial sale) Effective Date, including the Product packaging schedule based on existing purchase orders (the “First YearInitial Forecast”). The first (1st) within [***] of the Initial Forecast shall be binding on Purchaser, meaning that Purchaser shall purchase all quantities of stock keeping units produced in accordance with such Initial Forecast as reasonably required for the forecasted quantities of Products for such [***] period. Within [***] after (i) Acologix or its Sublicensee files the Effective Date, Purchaser shall provide Manufacturer with an updated Initial Forecast and Manufacturer shall use commercially reasonable efforts to meet such updated Initial Forecast; provided, however, no changes shall be made to the first NDA [***] of the Initial Forecast.
3.2 Updated Rolling Forecast for a Product in North America; or Products.
(iia) Acologix files the first MAA for a Product in Europe if Acologix is assigned responsibility by the JDCC for Commercialization of Injection Products in Europe, whichever is earlier. Acologix shall have the right to update that First Year forecast Beginning [***].
6.3.2 Acologix , Purchaser shall provide its first firm order by to Manufacturer, no later than [***] before ], an updated forecast of its requirements of Products for Distribution in the anticipated first Sales of United States during the Product. Upon placement of the first firm order by Acologix, the Parties shall be bound to the then-current forecast for the First Year (the “First Year Forecast”) as set forth in this Section 6.3.2, provided that the First Year Forecast shall not take into account any update provided by Acologix after the date that is following [***] prior to placement of period (the first firm order. Over “Rolling Forecast”) starting with the course of month following the First Year, Acologix month during which such Rolling Forecast was provided.
(b) The Rolling Forecast shall be obligated to place firm orders for no less than divided in [***] consecutive three (3) month periods (each, a “Quarter”) starting with the month following the month during which such Rolling Forecast was provided. The [***] of the First Year Forecast. Toray Rolling Forecast shall be obligated to accept and fulfill any firm orders placed by Acologix to binding (the extent “Binding Period”). The forecast for the total Binding Period shall be provided in monthly quantities of such firm orders in the First Year do not exceed number of packs of stock keeping units. The [***] Quarters of the First Year Rolling Forecast shall be semi-binding (the “Semi-Binding Period”), meaning that, in the next Rolling Forecast, and Toray shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amount.
6.3.3 Beginning with Purchaser may increase or decrease the calendar quarter in which Acologix places its first firm order, within quantities forecasted [***] after Manufacturer shall use commercially reasonable efforts to plan the end of each calendar quarter Acologix shall provide a rolling four quarter estimate of the volume manufacture of Products to meet Purchaser’s forecast for the Semi-Binding Period. The forecast for the Semi-Binding Period shall be order by Acologix provided in monthly quantities of number of packs of stock keeping units. The [***] Quarters of the Rolling Forecast are considered to be non-binding (the most recent estimate, the “Annual ForecastNon-Binding Period”). The forecast for the Non-Binding Period shall be provided in quarterly quantities of number of packs of specific stock keeping units. The Parties shall determine appropriate procedures acknowledge and binding terms and conditions related agree that Manufacturer’s application to the Annual DEA for DEA Procurement Quota for each calendar year will be based on Purchaser’s Forecast for Products for distribution in the Supply AgreementsUnited States for such calendar year and Seller’s (and its Affiliates’) forecasts for Seller Products for distribution outside the United States for such calendar year. Promptly after the DEA grants a DEA Procurement Quota to Manufacturer for any calendar year, Manufacturer will allocate such DEA Procurement Quota between Purchaser and Seller (and its Affiliates) in proportion to the forecasts used to prepare the application for such DEA Procurement Quota, and will notify Purchaser of the portion of such Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission. DEA Procurement Quota allocated to Purchaser (such portion, the “Purchaser DEA Procurement Quota”). Notwithstanding anything to this contrary in this Section 3.2, the quantities set forth in the Rolling Forecast shall not exceed the Purchaser DEA Procurement Quota for the applicable calendar year. If, after Manufacturer notifies Purchaser of the Purchaser DEA Procurement Quota for any calendar year, Purchaser demonstrates that an increase to such Purchaser DEA Procurement Quota is warranted by demand, Manufacturer will cooperate with Purchaser to apply to the DEA for an increase to the DEA Procurement Quota for such calendar year and, if necessary to satisfy the requested increase to the DEA Procurement Quota, an increase to the DEA Manufacturing Quota granted to Noramco for such calendar year and an increase to the DEA Aggregate Production Quota for such calendar year. Any requested increases to the DEA Procurement Quota, DEA Manufacturing Quota and DEA Aggregate Production Quota shall be subject to the approval of the DEA and shall be sought in accordance with DEA regulations, rules and procedures. If the DEA approves an increase to the DEA Procurement Quota (and any corresponding increase to the DEA Manufacturing Quota and DEA Aggregate Production Quota) sought in accordance with this Section 3.2(b), then: (i) the approved increase to the DEA Procurement Quota shall be added to the Purchaser DEA Procurement Quota for the applicable calendar year, (ii) Manufacturer may initiate the additional manufacture of Product (and, if necessary, request that Noramco initiate the manufacture of, or supply, the additional API needed for such additional Product) to satisfy the increase in the Purchaser DEA Procurement Quota, and (iii) Purchaser may update the Rolling Forecast to reflect the increased Purchaser DEA Procurement Quota. For the sake of clarity, in no event shall Manufacturer be required to apply any portion of the DEA Procurement Quota to the manufacture of Products for Purchaser other than the Purchaser DEA Procurement Quota.
(c) During the period prior to the effective date of the label change contemplated by Section 1.1(c), Purchaser and Manufacturer shall cooperate to minimize the number of Products packaged in Manufacturer’s trade dress and to maximize the number of Products packaged in Purchaser’s trade dress, which may include, without limitation, reasonable changes to existing Purchase Orders, the Binding Periods and Semi-Binding Periods and Purchase Orders with quantities below the Minimum Order Quantity.
Appears in 1 contract
Samples: Transitional Supply Agreement
Forecasts Orders. 6.3.1 Acologix shall provide Toray with an estimate of Commencing on the volume of Products to be ordered in the first four quarters of commercial supply of Products (i.e. the four consecutive calendar quarters beginning with the calendar quarter in which Acologix makes its first commercial sale) (the “First Year”) within [*****] after (i) Acologix or its Sublicensee files following the first NDA for execution of this Agreement, COMPANY shall provide HOVIONE with a Product in North America; or (ii) Acologix files the first MAA for a Product in Europe if Acologix is assigned responsibility by the JDCC for Commercialization of Injection Products in Europe, whichever is earlier. Acologix shall have the right to update that First Year forecast rolling [***].
6.3.2 Acologix **] forecast of COMPANY’s and its Affiliates’ anticipated orders of API for sales of the Product in the Territory, which forecast shall provide its be updated no less than [*****] during the Term (each, a “Forecast”). Each Forecast after the first firm order by Forecast shall be provided to HOVIONE no later than [*****] before after the anticipated first Sales start of [*****] to assist HOVIONE in planning its production. The [*****] of each Forecast shall be binding and the remaining [*****] shall be non-binding. COMPANY shall place firm orders for the API using its standard purchase orders (which shall be subject to the terms of this Agreement), setting forth the quantity of API required [*****], as well as its required Delivery Dates, which shall be in no event earlier than [*****] from the date of the Productpurchase order (any such purchase order, a “COMPANY Purchase Order”). Upon placement HOVIONE will notify COMPANY of its receipt of each COMPANY Purchase Order within [*****] thereafter. Such notice will include confirmation of the first firm order by AcologixDelivery Date, which shall be not less than [*****] from the date of the COMPANY Purchase Order issue date. If HOVIONE fails to notify COMPANY of its receipt of such COMPANY Purchase Order within such [*****] period, the Parties shall COMPANY Purchase Order will be bound deemed to the then-current forecast for the First Year (the “First Year Forecast”) as set forth have been received and accepted; provided, however, that if requested by COMPANY in this Section 6.3.2writing, provided that the First Year Forecast shall not take into account any update provided by Acologix after HOVIONE may agree, in its sole discretion, to deliver a shipment of API prior to the date that is [*****] prior to placement after the date of the first firm orderapplicable COMPANY Purchase Order. Over the course Within [*****] after a COMPANY Purchase Order issue date, COMPANY may request that additional quantity of the First YearAPI be Manufactured under such COMPANY Purchase Order, Acologix shall such additional quantity to be obligated to place firm orders for no delivered not less than [*****] after the COMPANY Purchase Order to which such additional quantity request relates; provided, that only such additional quantity of the First Year Forecast. Toray API, which shall not be obligated to accept and fulfill any firm orders placed by Acologix to the extent the total of such firm orders in the First Year do not exceed greater than [*****] of the First Year Forecast, and Toray shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amount.
6.3.3 Beginning with the calendar quarter in which Acologix places its first firm order, within applicable COMPANY Purchase Order [***] after **], may be requested unless otherwise agreed to in writing by HOVIONE. HOVIONE shall use commercially reasonable efforts to Manufacture any such additional quantity, subject to HOVIONE’s other supply commitments and capacity. In the end event of each calendar quarter Acologix shall provide a rolling four quarter estimate any conflict between the provisions of the volume this Agreement and any COMPANY Purchase Order, acknowledgement, invoice, xxxx of Products to be order lading, acceptance or other preprinted form provided by Acologix (the most recent estimateeither Party, the “Annual Forecast”)provisions of this Agreement shall control. The No additional provision in any other document shall apply unless both Parties explicitly agree in writing that such additional provision shall determine appropriate procedures and binding terms and conditions related apply to the Annual Forecast in Parties rights and obligations under this Agreement. Notwithstanding the Supply Agreements.above, HOVIONE has agreed to use commercially reasonable efforts to manufacture [*****]
Appears in 1 contract
Samples: Manufacturing Agreement (Anacor Pharmaceuticals, Inc.)
Forecasts Orders. 6.3.1 Acologix 6.1. Within ten (10) business days after the Effective Date, and thereafter within ten (10) business days after the start of each Quarter during the Term, DENDREON shall provide Toray with an estimate of submit to DIOSYNTH a [ *** ] rolling forecast for its anticipated requirements for Ancillary Component for the volume of Products to be ordered in the first four quarters of commercial supply of Products succeeding [ *** ] Quarters (i.e. the four consecutive calendar quarters beginning with the calendar quarter Quarter in which Acologix makes the forecast is due). Notwithstanding the provisions of this Section 6.1, the forecasts that DENDREON is to provide hereunder need not extend beyond this Agreement’s Term.
6.2. DENDREON shall submit to DIOSYNTH a binding Order for the first Campaign by January 1, 2006. DENDREON does not anticipate placing an additional Order until[ *** ]; accordingly, DIOSYNTH shall be free to fill its intermediate scale cell culture facility with other customers from[ *** ]. In addition, following DENDREON’s placement of any Order for a [ *** ] month Campaign, DIOSYNTH shall be free to fill its intermediate scale cell culture facility with other customers for the [ *** ] month period beginning [ *** ] months after the Order Campaign Start Date for that [ *** ] month Campaign and following DENDREON’s placement of any Order for a [ *** ] -month Campaign, DIOSYNTH shall be free to fill its intermediate scale cell culture facility with other customers for the [ *** ] -month period beginning [ *** ] months after the Order Campaign Start Date for that [ *** ] month Campaign.
6.3. DENDREON’s first commercial sale) Order for a Campaign under Section 6.2, and all subsequent Orders, shall be submitted to DIOSYNTH at least [ *** ] months prior to the requested Campaign Start Date that is specified in the Order (such specified Campaign Start Date, the “First YearOrder Campaign Start Date”).
6.4. Each Order shall be for a [ *** ] month Campaign and shall specify (i) the Order Campaign Start Date; (ii) the length of the Campaign; and (iii) the designated carrier for delivery of Ancillary Component.
6.5. DIOSYNTH shall respond to a written Order from DENDREON within ten (10) business days (an “Order Acceptance”) within to accept the Order and confirm an estimated Campaign Start Date, which shall be no later than the Order Campaign Start Date, and which shall be confirmed in writing at least six (6) month prior to the Order Campaign Start Date, and the Estimated Campaign Completion Date, and which shall include the applicable Minimum Gram Guarantee for the Campaign.
6.6. After receiving an Order for a Campaign, DENDREON shall have the right and option to extend the Campaign for up to an additional [ *** ] months; provided that DIOSYNTH has available manufacturing capacity and raw materials. If the Campaign is extended from a [ *** ] month Campaign to a [ *** ] month Campaign, [***] after DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION then DIOSYNTH may invoice DENDREON as if the extension was a new Order for a [ *** ] month Campaign (provided that DENDREON shall receive a credit for any amounts previously paid by DENDREON on the original Order for the [ *** ] month Campaign). Likewise, if the Campaign is extended from either a [ *** ] month Campaign to a[ *** ] month Campaign, then DIOSYNTH may invoice DENDREON as if the extension was a new Order for a [ *** ] month Campaign (provided that DENDREON shall receive a credit for any amounts previously paid by DENDREON on the original Order for the [ *** ] month Campaign).
6.7. The Parties recognize that this Agreement is for the manufacturing and delivery of Ancillary Component and that there is an interval of approximately [ *** ] weeks between completion of manufacture of Ancillary Component and Disposition of Ancillary Component.
6.8. Once an Order has been placed, it shall be binding on both Parties (except as provided in Section 3.7) and (i) Acologix or its Sublicensee files DENDREON shall be responsible for payment of the first NDA for a Product price of such Order as set forth in North America; or Section 4.2, subject to DENDREON’s cancellation rights under Section 6.9, and (ii) Acologix files DIOSYNTH shall be responsible to fulfill the Order by the dates set forth therein.
6.9. With the exception of the first MAA for a Product in Europe if Acologix is assigned responsibility by the JDCC for Commercialization of Injection Products in EuropeOrder, whichever is earlier. Acologix DENDREON shall have the right to update that First Year forecast [cancel any Orders submitted hereunder, subject to the following:
(a) If the cancellation occurs [ ***]* ] months or more before the Order Campaign Start Date, the cancellation shall be without charge or other liability to DENDREON.
6.3.2 Acologix (b) If the cancellation occurs at least [ *** ] months, but no more than [ *** ] months, before the Order Campaign Start Date, DENDREON shall provide its first firm order be responsible for a percentage of the Campaign Base Price of the Campaign specified in the Order (as set forth in Schedule 2, based on the assumption of delivery of the then-current Minimum Gram Guarantee) and one hundred percent (100%) of the Actual Consumables Payment. The cancellation fee will be determined as follows:
i. [ *** ] month Campaign –[ *** ] of the Campaign Base Price will be paid by DENDREON.
ii. [ *** ] Month Campaign [ *** ] of the Campaign Base Price will be paid by DENDREON.
iii. [ *** ] Month Campaign [ *** ] of the Campaign Base Price will be paid by DENDREON.
(c) If the cancellation occurs before the Order Campaign Start Date, but no later more than [ *** ] before the Order Campaign Start Date, DENDREON shall be responsible for a percentage of the Campaign Base Price of the Campaign specified in the Order (as set forth in Schedule 2, based on the assumption of delivery of the then-current Minimum Gram Guarantee) and one hundred percent (100%) of the Actual Consumables Payment. The cancellation fee will be applied as follows:
i. [ *** ] month Campaign –[ *** ] of the Campaign Base Price will be paid by DENDREON. [***] before the anticipated first Sales DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION ii. [ *** ] Month Campaign [ *** ] of the ProductCampaign Base Price will be paid by DENDREON.
iii. Upon placement [ *** ] Month Campaign [ *** ] of the first firm order Campaign Base Price will be paid by AcologixDENDREON.
(d) If the cancellation occurs on or after the Order Campaign Start Date, the Parties DENDREON shall be bound responsible for [ *** ] of the Campaign Base Price plus the higher value of the Estimated Consumables Payment or the Actual Consumables Payment.
(e) DIOSYNTH shall use all reasonable efforts to mitigate its losses where DENDREON cancels an Order, including, among other things, using the Process Consumables for other customers of DIOSYNTH and returning Process Consumables for cash or credit wherever possible. DIOSYNTH shall promptly notify DENDREON of any losses it is able to mitigate, and DENDREON’S payment obligations under this Section 6.9 shall be reduced to the extent that DIOSYNTH mitigates its losses in this regard.
(f) Any amounts paid by DENDREON for a Campaign under Section 4 shall be fully credited against amounts due under this Section 6.9. To the extent amounts paid under Section 4 exceed amounts payable under this Section 6.9, DIOSYNTH shall promptly refund the difference to DENDREON.
6.10. DENDREON shall have the right to reduce any Order submitted hereunder, subject to the following:
(a) DENDREON may not change the Order Campaign Start Date.
(b) DENDREON may reduce any Order to a shorter Campaign without penalty no less than [ *** ] months prior to the Order Campaign Start Date.
(c) DENDREON may reduce any Order from [ *** ] months prior to the Order Campaign Start Date through the Campaign Start Date, subject to the following:
i. Campaign reduction fees to be paid by DENDREON will be calculated based on reduced Campaign length in increments of [ *** ] months.
ii. For a reduction of [ *** ] months from a [ *** ] month to a [ *** ] month Campaign, DENDREON shall pay to DIOSYNTH [ *** ] [ *** ] of the difference in Campaign Base Prices (as set forth in Schedule 2, based on the assumption of delivery of the then-current forecast for Minimum Gram Guarantee).
iii. For a reduction of [ *** ] months from a [ *** ] month to a[ *** ] month Campaign, DENDREON shall pay to DIOSYNTH [ *** ] of the First Year difference in Campaign Base Prices (the “First Year Forecast”) as set forth in this Section 6.3.2Schedule 2, provided that based on the First Year Forecast assumption of delivery of the then-current Minimum Gram Guarantee.
iv. For a reduction of [ *** ] months from a [ *** ] month to a [ *** ] month Campaign DENDREON shall not take into account pay to DIOSYNTH a reduction fee equal to [ *** ] of the difference in the Campaign Base Prices (as set forth in Schedule 2, based on the assumption of delivery of the then-current Minimum Gram Guarantee).
v. DENDREON shall pay to DIOSYNTH the Actual Consumables Payment for the reduced Order, including payment for any update provided surplus consumable irrevocably committed by Acologix after DIOSYNTH for the date that is Original Order Campaign. [***] prior to placement of the first firm order. Over the course of the First Year, Acologix shall be obligated to place firm orders for no less than [***] of the First Year Forecast. Toray shall be obligated to accept and fulfill any firm orders placed by Acologix to the extent the total of such firm orders in the First Year do not exceed [***] of the First Year Forecast, and Toray shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amount.
6.3.3 Beginning with the calendar quarter in which Acologix places its first firm order, within [***] after the end of each calendar quarter Acologix shall provide a rolling four quarter estimate of the volume of Products to be order by Acologix (the most recent estimate, the “Annual Forecast”). The Parties shall determine appropriate procedures and binding terms and conditions related to the Annual Forecast in the Supply Agreements.DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
Appears in 1 contract
Samples: Supply Agreement (Dendreon Corp)
Forecasts Orders. 6.3.1 Acologix a. Forecasts [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. Page 13 of 50
(a) During the Term, [ * ], Seattle Genetics shall provide Toray Corden with an estimate of the volume of Products to be ordered in the first four quarters of commercial supply of Products a rolling [ * ] forecast (i.e. the four consecutive calendar quarters beginning with the calendar quarter in which Acologix makes its first commercial sale) (the “First Year”) within [***] after (i) Acologix or its Sublicensee files the first NDA for a Product in North America; or (ii) Acologix files the first MAA for a Product in Europe if Acologix is assigned responsibility by the JDCC for Commercialization of Injection Products in Europe, whichever is earlier. Acologix shall have the right to update that First Year forecast [***].
6.3.2 Acologix shall provide its first firm order by no later than [***] before the anticipated first Sales of the Product. Upon placement of the first firm order by Acologix, the Parties shall be bound to the then-current forecast for the First Year (the “First Year Rolling Forecast”) as set forth indicating Seattle Genetics’ expected delivery of Product for the next [ * ], in this Section 6.3.2, provided that the First Year Forecast shall not take into account any update provided by Acologix after the date that is [***] prior to placement of the full batch sizes. The first firm order. Over the course of the First Year, Acologix shall be obligated to place firm orders for no less than [***[ * ] of the First Year Forecast. Toray Rolling Forecast [ * ] shall be obligated to accept and fulfill any firm orders placed by Acologix to the extent the total of such firm orders in the First Year do not exceed [***] of the First Year considered binding for both Parties under this Section 3 (“Binding Forecast”), and Toray the second [ * ] shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amount.
6.3.3 Beginning with the calendar quarter in which Acologix places its first firm order, within [***] after the end of each calendar quarter Acologix shall provide a rolling four quarter estimate of the volume of Products to be order by Acologix considered non-binding for both Parties (the most recent estimate, the “Annual Non-Binding Forecast”). The Parties initial Rolling Forecast is attached hereto as Schedule 1, and each subsequent update will be due on or before [ * ] of each new calendar quarter during the Term (covering [ * ]).
(b) Corden shall determine appropriate procedures and binding terms and conditions related review each update to the Annual Rolling Forecast and assess if it is able to manufacture or otherwise supply Seattle Genetics’ requirements for Product in excess of the amount set forth in the Supply Agreementsprevious Binding Forecast, if any, and assuming that the remainder of the Rolling Forecast will become binding in time as contemplated by this Agreement. In the event that, upon receipt of an updated Rolling Forecast, Corden anticipates that it shall not be able to manufacture or otherwise supply Seattle Genetics’ requirements for Product in excess of the amount set forth in the previous Binding Forecast, Corden shall inform Seattle Genetics in writing within [ * ] after Corden’s receipt of said updated Rolling Forecast, and Seattle Genetics shall then be entitled to obtain from alternative suppliers any such excess amount of Product which Corden has indicated that it would not be able to manufacture or otherwise supply for Seattle Genetics. For the avoidance of doubt, Corden will not be obliged to manufacture any portion of the initial Binding Forecast that requires a capital investment in the Production Facility, unless otherwise agreed by Corden.
(c) Non-Binding Forecasts provided by Seattle Genetics shall be made in good faith, [ * ]. For clarity, as [ * ], it will automatically become binding except to the extent Seattle Genetics increases the amount forecast for such quarter by [ * ] over the previous Non-Binding Forecast. The Parties agree to discuss as soon as practicable any such overage request, provided Corden will use commercially reasonable efforts to fulfill such overage and any other additional Product requirement of Seattle Genetics not contemplated by the updated Binding Forecast.
(d) If [ * ], Seattle Genetics may, [ * ], provide a revised Rolling Forecast, including a revised Binding Forecast and Non-binding Forecast. In this case, Seattle Genetics shall [ * ]. Corden shall use commercially reasonable efforts to make use of the unblocked production capacity for other customers in order to minimize any costs for unused capacity. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. Page 14 of 50 (e) Within [ * ] after receipt of each Rolling Forecast, Corden shall submit to Seattle Genetics a corresponding good faith, non-binding, estimated rolling forecast of Corden’s expected requirements of/for Seattle Genetics Material based on such Rolling Forecast (taking into account any quantities of Seattle Genetics Material already on hand at the Production Facility). Each such forecast provided by Corden shall include a reasonable safety stock of Seattle Genetics Material (sufficient to manufacture at least the next calendar quarter’s Binding Forecast).
Appears in 1 contract
Samples: Commercial Supply Agreement (Seattle Genetics Inc /Wa)
Forecasts Orders. 6.3.1 Acologix a. Supplier shall provide Toray with an estimate to Commercialization Partner or its designated Distributor or Distributor Affiliates on the first business day of each week:
(i) The number of Product Units available in Supplier’s inventory for immediate sale to customers and the location of such inventory; and
(ii) A good faith rolling weekly forecast of the volume Product Units Supplier expects to have available for sale to customers for the succeeding four weeks.
b. Commercialization Partner or its designated Distributor or Distributor Affiliates shall provide Supplier at least one month in advance with a good faith rolling quarterly sales forecast for the Product Units to be provided by Supplier to Commercialization Partner or its designated Distributor or Distributor Affilliates hereunder during each month in such calendar quarter.
c. Commercialization Partner of its designated Distributor or Distributor Affiliates shall initiate purchases under this Agreement by submitting written purchase orders (each, an “Order”) to Supplier. Such orders shall state unit quantities, unit descriptions, requested delivery dates, and shipping instructions. Distributor shall be entitled to specify in an Order that the Product Units to be delivered pursuant to that Order shall have been manufactured in the United States. No purchase order shall be binding upon Supplier until accepted by Supplier in writing. Supplier reserves the right to reject orders in whole or in part. Partial shipment of an order shall not constitute acceptance of the entire order. In the event that Supplier is unable to fill an accepted purchase order in accordance with the schedule set forth therein, Supplier will use commercially reasonable efforts to fill such order on an allotment basis. This Agreement shall govern all orders placed by the Commercialization Partner or its designated Distributor or Distributor Affiliates for Products and Product Units.
d. Supplier shall submit an invoice to the Commercialization Partner or its designated Distributor or Distributor Affiliates upon shipment of Products to the Commercialization Partner or its customers. The invoice shall state the amount to be paid by the Commercialization Partner or its designated Distributor or Distributor Affiliates for all Products in such shipment. Commercialization Partner or its designated Distributor or Distributor Affiliates will pay for such Orders within thirty (30) days after receipt of invoice.
e. Products sold to Commercialization Partner or its designated Distributor or Distributor Affiliates shall be packaged in Supplier’s standard containers, or, at the Distributor’s expense, in accordance with instructions provided by the Distributor, and shall be shipped to such address(es) as are specified in the Order.
f. Distributor shall have thirty (30) days (the “Inspection Period”) following its (or a customer’s) receipt of each shipment to inspect and test the Products. If Commercialization Partner or its designated Distributor or Distributor Affiliates determine any unit of Products to be ordered in defective, the first four quarters of commercial supply of Products (i.e. the four consecutive calendar quarters beginning with the calendar quarter in which Acologix makes its first commercial sale) (the “First Year”) within [***] after (i) Acologix Commercialization partner or its Sublicensee files designated Distributor or Distributor Affiliates shall promptly notify Supplier of such defects. Products determined to be defective by Supplier may be returned to Supplier at Supplier’s expense for retest, evaluation and examination. Supplier will inspect all Products returned and will replace defective Products except where the first NDA for defect is due to misuse, neglect, alteration or improper storage by Commercialization Partner or its designated Distributor or Distributor Affiliates. Prior to returning any Product, Commercialization Partner or its designated Distributor or Distributor Affiliates must obtain a Product in North America; or (ii) Acologix files the first MAA for a Product in Europe if Acologix is assigned responsibility by the JDCC for Commercialization of Injection Products in Europe, whichever is earlier. Acologix shall have the right to update that First Year forecast [***]written return authorization from Supplier.
6.3.2 Acologix shall g. Commercialization Partner or its designated Distributor or Distributor Affiliates will provide its first firm order by no later than [***] before the anticipated first Sales of the Product. Upon placement of the first firm order by Acologix, the Parties shall be bound to the then-current forecast for the First Year (the “First Year Forecast”) as set forth in this Section 6.3.2, provided that the First Year Forecast shall not take into account any update provided by Acologix after the date that is [***] prior to placement of the first firm order. Over the course of the First Year, Acologix shall be obligated to place firm orders for no less than [***] of the First Year Forecast. Toray shall be obligated to accept and fulfill any firm orders placed by Acologix to the extent the total of such firm orders in the First Year do not exceed [***] of the First Year Forecast, and Toray shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amountSupplier a sales tracking report on a monthly basis.
6.3.3 Beginning with the calendar quarter in which Acologix places h. Commercialization Partner or its first firm order, within [***] after the end of each calendar quarter Acologix shall designated Distributor or Distributor Affiliates will provide a rolling four quarter estimate Chargeback/Rebate report on a monthly basis or as determined by Distributor in its sole discretion.
i. Commercialization Partner or its designated Distributor or Distributor Affiliates will maintain complete and accurate records for such periods as may be required by applicable law, of all the volume of Products to be order sold by Acologix (the most recent estimate, the “Annual Forecast”). The Parties shall determine appropriate procedures and binding terms and conditions related to the Annual Forecast in the Supply Agreementsit.
Appears in 1 contract
Samples: Commercialization Partnership Agreement (Avalon GloboCare Corp.)
Forecasts Orders. 6.3.1 Acologix 4.1. No later than ninety (90) days prior to the anticipated date of first delivery of the first Licensed Product, GALDERMA shall provide Toray ANIKA with an estimate its initial written forecast of GALDERMA’s anticipated requirements for such Licensed Product by SKU for each of the volume first twelve (12) months following such date of Products first delivery (such initial forecast and all future forecasts herein referred to be ordered in the first four quarters of commercial supply of Products (i.e. the four consecutive calendar quarters beginning with the calendar quarter in which Acologix makes its first commercial sale) (as a “Forecast” or the “First YearForecasts”) within [***] after (i) Acologix or its Sublicensee files the first NDA ); provided, however, that such initial Forecast shall not provide for a Product in North America; or (ii) Acologix files the first MAA for a Product in Europe if Acologix is assigned responsibility by the JDCC for Commercialization delivery of Injection Products in Europe, whichever is earlier. Acologix shall have the right to update that First Year forecast [***].
6.3.2 Acologix shall provide its first firm order by no later more than [****************] before the anticipated first Sales Units of the Product. Upon placement of such Licensed Product per month in the first firm order by Acologix, the Parties shall be bound to the then-current forecast for the First Year (the “First Year Forecast”) as set forth in this Section 6.3.2, provided that the First Year Forecast shall not take into account any update provided by Acologix after the date that is [****************] of such Forecast without ANIKA’s written consent. From and after the delivery of the initial Forecast, no later than fifteen (15) days prior to placement the commencement of each calendar month during the Term, GALDERMA shall provide ANIKA with a revised Forecast by SKU covering each of the following twelve (12) months. With respect to all Forecasts issued to ANIKA by GALDERMA pursuant to the terms hereof, (i) [****************] of the first firm order. Over the course and second months, (ii) [****************] of the First Yearthird and fourth months, Acologix and (iii) [****************] of the fifth and sixth months, in each case shall be obligated become binding on the Parties on a rolling basis and constitute a firm order for Licensed Products, regardless of receipt by ANIKA of GALDERMA’s actual Purchase Orders, it being understood and agreed that each Forecast shall reflect at least the quantities that are binding on the Parties pursuant to place firm orders the foregoing thresholds and no more than the maximum quantities contemplated by the first sentence of Section 4.2 below. For example, if the first Forecast provides for a quantity of [********] Units in the third month of such Forecast, no subsequent Forecast shall provide for a quantity with respect to such month of less than [*****] of the First Year Forecast. Toray shall be obligated to accept and fulfill any firm orders placed by Acologix to the extent the total of such firm orders in the First Year do not exceed Units or more than [******] of Units. Each Forecast will indicate the First Year Forecastdelivery dates for the Licensed Products, and Toray shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amount.
6.3.3 Beginning with the calendar quarter in which Acologix places its delivery dates for the first firm order, within [*******************] after will be binding on the end Parties as indicated in such Forecast; provided, however, that such delivery dates for the number of Units of Licensed Product forecasted for a month in the then current Forecast must fall within such month, unless the Parties otherwise agree in writing to alternative delivery dates.
4.2. Subject to the binding commitment incurred pursuant to each calendar quarter Acologix Forecast pursuant to Section 4.1, GALDERMA shall provide a rolling four quarter estimate place specific binding orders for Licensed Product by the issuance of separate purchase orders to ANIKA, which may be in written or electronic form or by any other means agreed to by the Parties and shall be binding on ANIKA to the extent that such purchase orders [*******************] by SKU by month of the volume applicable Forecast with respect to the first and second months of Products such Forecast, [************] by SKU by month of such Forecast with respect to be order the third and fourth months, and [**********] by Acologix SKU by month of such Forecast with respect to the fifth and sixth months (the most recent estimate, the “Annual ForecastPurchase Orders”). If GALDERMA requests a quantity of Licensed Product that exceeds the binding portion of a given Forecast, the Parties agree in good faith to negotiate additional quantities and associated delivery dates. The Parties Purchase Orders shall determine appropriate procedures designate the desired SKU’s and binding terms and conditions related quantities of Licensed Products (subject to the Annual Forecast in requirements of this Section 4.2), delivery dates (subject to the Supply Agreementslast sentence of Section 4.1) and destinations. The minimum Purchase Order quantity by SKU shall be [*************] Units. GALDERMA shall issue written Purchase Orders for Licensed Products to ANIKA at least sixty (60) days prior to the requested delivery dates.
4.3. In the event that GALDERMA shall fail to place sufficient Purchase Orders to satisfy the binding order commitment incurred pursuant to any Forecast, such Purchase Orders shall be deemed to have been submitted by GALDERMA, and ANIKA shall deliver such Licensed Products to GALDERMA.
4.4. To the extent of any conflict or inconsistency between this Agreement and any Purchase Order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern.
Appears in 1 contract