Common use of Forecasts Orders Clause in Contracts

Forecasts Orders. (i) LMI shall send to HSL a **** (****) month forecast (the “Initial Forecast”) for the volume of Product which LMI expects to have delivered from HSL during such ****-month period. LMI shall provide the Initial Forecast for Product to HSL within **** (****) days after HSL is approved as a supplier of Product under the Product NDA. LMI shall thereafter update such forecast at least **** prior to the first 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 quantities of Product ordered by LMI. (ii) Subject to the 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 any portion thereof), it shall place orders with HSL for at least **** percent (****%) of its aggregate requirements for Product in the jurisdictions in the Territory where HSL is approved as a qualified supplier of the Product. 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 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 issued 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 acknowledge that the aggregate requirements for 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 Agreement 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, in the 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 way of example through one or more of the 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 each calendar year. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from **** percent (****%) to **** 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 Scoring Year, LMI shall send to HSL a 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 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 compliance” with the methodology for such Scoring Year.

Appears in 2 contracts

Sources: 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 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) LMI 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 send have the right to HSL a update that First Year forecast [**** (]. 6.3.2 Acologix shall provide its first firm order by no later than [****) month forecast (] before the “Initial Forecast”) for the volume of Product which LMI expects to have delivered from HSL during such ****-month period. LMI shall provide the Initial Forecast for Product to HSL within **** (****) days after HSL is approved as a supplier of Product under the Product NDA. LMI shall thereafter update such forecast at least **** prior to the anticipated first 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 quantities of Product ordered by LMI. (ii) Subject to the 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 any portion thereof), it shall place orders with HSL for at least **** percent (****%) of its aggregate requirements for Product in the jurisdictions in the Territory where HSL is approved as a qualified supplier Sales of the Product. This requirement Upon placement of the first firm order by Acologix, the Parties shall commence on a countrybe bound to the then-by-country basis current forecast for the First Year (the “First Year Forecast”) as set forth in this Section 6.3.2, provided that the Territory on 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 [****) day after HSL is qualified as a supplier ] of the Product under First Year Forecast. Toray shall be obligated to accept and fulfill any firm orders placed by Acologix to the applicable regulatory approval in extent the total of 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 firm orders in the Territory. During any period in which HSL’s manufacture for a jurisdiction is First Year do 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 issued 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 acknowledge that the aggregate requirements for 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 Agreement 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, in the 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 way of example through one or more of the following mechanisms: exceed [****] of the First Year Forecast, and Toray shall use best efforts to fulfill any amounts ordered by Acologix in excess of such amount. (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 each calendar year. For each calendar year from and after 6.3.3 Beginning with the calendar year quarter in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 ProductAcologix places its first firm order, then the minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from within [**** percent (****%) to **** 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 Scoring Year, LMI calendar quarter Acologix shall send to HSL provide a 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 rolling four quarter estimate of the highest Score for volume of Products to be order by Acologix (the immediately preceding Scoring Yearmost recent estimate, provided that such expert’s report the “Annual Forecast”). The Parties shall determine appropriate procedures and binding terms and conditions related to HSL shall be limited to an indication from such expert that LMI is “the Annual Forecast in compliance” or “out of compliance” with the methodology for such Scoring YearSupply Agreements.

Appears in 2 contracts

Sources: Collaboration and License Agreement (Acologix, Inc.), Collaboration and License Agreement (Acologix, Inc.)

Forecasts Orders. (i) LMI shall send to HSL a **** (****) month forecast (the “Initial Forecast”) for the volume of Product which LMI expects to have delivered from HSL during such ****-month period. LMI a. Supplier shall provide the Initial Forecast for Product to HSL within **** (****) days after HSL is approved as a supplier of Product under the Product NDA. LMI shall thereafter update such forecast at least **** prior 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 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 month thereafter quarter. c. Commercialization Partner of its designated Distributor or Distributor Affiliates shall initiate purchases under this Agreement by submitting written purchase orders (a each, an Subsequent ForecastOrder) to Supplier. Such orders shall state unit quantities, unit descriptions, requested delivery dates, and together with shipping instructions. Distributor shall be entitled to specify in an Order that 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, Product Units to be used for planning purposes only, and Forecasts delivered pursuant to that Order shall not constitute binding have been manufactured in the United States. No purchase orders, except that the first **** (****) months of each Forecast order shall be binding upon LMI and LMI 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 place purchase orders corresponding to not constitute acceptance of the binding portion of such Forecastentire order. 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 that Supplier is unable to fill an accepted purchase order for Product covered by in accordance with the binding portion of the Forecast. HSL schedule set forth therein, Supplier will use all commercially reasonable efforts to accommodate any changes in quantities of 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 ordered by LMIUnits. (ii) Subject d. Supplier shall submit an invoice to the terms Commercialization Partner or its designated Distributor or Distributor Affiliates upon shipment 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 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 any portion thereof), it shall place orders with HSL for at least **** percent (****%) of its aggregate requirements for Product in the jurisdictions in the Territory where HSL is approved as a qualified supplier of the Product. 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 Product under the applicable regulatory approval all Products in such country and end on the earlier of the termination shipment. Commercialization Partner 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 its designated Distributor or Distributor Affiliates will pay for such jurisdiction and/or not 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 material compliance with Supplier’s standard containers, or, at the applicable laws of such jurisdictionDistributor’s expense, 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 issued 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 Forecastcustomer’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 defective, the quantities Commercialization partner or its 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 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 written return authorization from Supplier. g. Commercialization Partner or its designated Distributor or Distributor Affiliates will provide to Supplier a sales tracking report on a monthly basis. h. Commercialization Partner or its designated Distributor or Distributor Affiliates will provide a Chargeback/Rebate report on a monthly basis or as determined by Distributor 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 acknowledge that the aggregate requirements for Product set forth above include both LMI’s its sole discretion. i. Commercialization Partner or its designated Distributor or Distributor Affiliates will maintain complete and its Affiliates’ requirements accurate records for such Product and that HSL’s rights set forth in Section 2.2(a)(iv) of this Agreement 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, in the 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 way of example through one or more of the 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 periods as may be reasonably necessary to verify required by applicable law, of all the accuracy of LMI’s orders for the immediately preceding calendar yearProducts sold by it. (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 each calendar year. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from **** percent (****%) to **** 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 Scoring Year, LMI shall send to HSL a 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 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 compliance” with the methodology for such Scoring Year.

Appears in 1 contract

Sources: Commercialization Partnership Agreement (Avalon GloboCare Corp.)

Forecasts Orders. 6.1. Within ten (i10) LMI business days after the Effective Date, and thereafter within ten (10) business days after the start of each Quarter during the Term, DENDREON shall send submit to HSL DIOSYNTH a *[ *** (****) month ] rolling forecast (the “Initial Forecast”) for its anticipated requirements for Ancillary Component for the volume of Product which LMI expects to have delivered from HSL during such ****-month period. LMI shall provide the Initial Forecast for Product to HSL within *succeeding [ *** ] Quarters (****) days after HSL beginning with the Quarter in which the forecast is approved as 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 supplier of Product under binding Order for the Product NDAfirst Campaign by January 1, 2006. LMI shall thereafter update such forecast at least *DENDREON does not anticipate placing an additional Order until[ *** prior ]; accordingly, DIOSYNTH shall be free to the first business day of each calendar month thereafter (a “Subsequent Forecast”, and together fill its intermediate scale cell culture facility with the Initial Forecast, a “Forecast”), providing HSL with a rolling *other customers from[ *** (****) 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 quantities of Product ordered by LMI. (ii) Subject to the 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 any portion thereof), it shall place orders with HSL for at least **** percent (****%) of its aggregate requirements for Product in the jurisdictions in the Territory where HSL is approved as a qualified supplier of the Product. 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 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 following DENDREON’s placement of HSL’s approval as a supplier of Product any Order for a jurisdiction [ *** ] 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 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 TerritoryOrder (such specified Campaign Start Date, the “Order Campaign Start Date”). 6.4. During any period in which HSL’s manufacture Each Order shall be for a jurisdiction is not [ *** ] 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”) 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 compliance with cGMPs for such jurisdiction and/or not in material compliance with 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 laws 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, [***] 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) DENDREON shall be responsible for payment of the price 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 issued 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 acknowledge that the aggregate requirements for Product set forth above include both LMI’s and its Affiliates’ requirements for such Product and that HSL’s rights Order as set forth in Section 2.2(a)(iv4.2, subject to DENDREON’s cancellation rights under Section 6.9, and (ii) DIOSYNTH shall be responsible to fulfill the Order by the dates set forth therein. 6.9. With the exception of this Agreement extend the first Order, DENDREON shall have the right to cancel any Orders submitted hereunder, subject to the books and records of both LMI and its Affiliatesfollowing: (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. (iiib) Without limiting HSL’s remedies If the cancellation occurs at least [ *** ] months, but no more than [ *** ] months, before the Order Campaign Start Date, DENDREON shall be responsible for a percentage of the Campaign Base Price of the Campaign specified in the event Order (as set forth in Schedule 2, based on the assumption of a breach delivery of the preceding paragraphthen-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 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 event LMI fails to order the requirements Order (as set forth above in Schedule 2, based on the Parties may discuss and agree on making HSL whole (including recovery assumption of lost profits), such as by way of example through one or more delivery of the following mechanisms: 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. [***] 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 Campaign Base Price will be paid by DENDREON. iii. [ *** ] Month Campaign [ *** ] of the Campaign Base Price will be paid by DENDREON. (ivd) LMI If the cancellation occurs on or after the Order Campaign Start Date, DENDREON shall maintain accurate and complete books and records of its purchases be responsible 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 Campaign Base Price plus 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 higher value of the records of LMI as may be reasonably necessary to verify Estimated Consumables Payment or the accuracy of LMI’s orders for the immediately preceding calendar yearActual Consumables Payment. (ve) LMI 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 establish performance parameters and weightings 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 Minimum Gram Guarantee). iii. 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 Minimum Gram Guarantee. iv. For a reduction of [ *** ] months from a [ *** ] month to a [ *** ] month Campaign DENDREON shall 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 Product to determine a performance score (“Score”) and communicate reduced Order, including payment for any surplus consumable irrevocably committed by DIOSYNTH for the same to HSL prior to each calendar yearOriginal Order Campaign. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from [**** percent (****%) to **** 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 Scoring Year, LMI shall send to HSL a 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 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 compliance” with the methodology for such Scoring Year.] 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

Sources: Supply Agreement (Dendreon Corp)

Forecasts Orders. a. Forecasts [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (iI) LMI NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. Page 13 of 50 (a) During the Term, [ * ], Seattle Genetics shall send to HSL provide Corden with a ***rolling [ * (****) month ] forecast (the Initial Rolling Forecast”) indicating Seattle Genetics’ expected delivery of Product for the volume next [ * ], in full batch sizes. The first [ * ] of Product which LMI expects to have delivered from HSL during such ****-month period. LMI the Rolling Forecast [ * ] shall provide the Initial Forecast be considered binding for Product to HSL within **** both Parties under this Section 3 (****) days after HSL is approved as a supplier of Product under the Product NDA. LMI shall thereafter update such forecast at least **** prior to the first business day of each calendar month thereafter (a Subsequent Forecast”, and together with the Initial Forecast, a “Binding Forecast”), providing HSL with a rolling ***and the second [ * ] shall be considered non-binding for both Parties (****) month forecast for Product“Non-Binding Forecast”). Each The initial Rolling Forecast shall include an estimated number is attached hereto as Schedule 1, and each subsequent update will be due on or before [ * ] of Batches for each month new calendar quarter during the ****-month period covered by such Forecast. Amounts Term (covering [ * ]). (b) Corden shall review each update to the 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 a Forecast are estimatesthe previous Binding Forecast, to be used for planning purposes onlyif any, and Forecasts shall not constitute binding purchase orders, except assuming that the first **** (****) months remainder of each the Rolling Forecast shall be will become binding upon LMI and LMI shall place purchase orders corresponding to the binding portion of such Forecastin time as contemplated by this Agreement. In the event LMI does not place purchase orders against the binding portion that, upon receipt of a an updated Rolling Forecast, HSL may (but Corden anticipates that it shall not be required to) deem such binding Forecast as a purchase order able to manufacture or otherwise supply Seattle Genetics’ requirements for Product covered by in excess of the binding 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. HSL The Parties agree to discuss as soon as practicable any such overage request, provided Corden will use all commercially reasonable efforts to accommodate fulfill such overage and any changes in quantities other additional Product requirement of Product ordered Seattle Genetics not contemplated by LMIthe updated Binding Forecast. (iid) Subject 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 terms 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 this Agreement 50 (includinge) Within [ * ] after receipt of each Rolling Forecast, but not limited toCorden shall submit to Seattle Genetics a corresponding good faith, Sections 5.1non-binding, 5.5 and 9.5estimated 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), LMI agrees that, during each calendar year . Each such forecast provided by Corden shall include a reasonable safety stock of this Agreement Seattle Genetics Material (with a pro-rata adjustment as applicable for any portion thereof), it shall place orders with HSL for sufficient to manufacture at least **** percent (****%) of its aggregate requirements for Product in the jurisdictions in the Territory where HSL is approved as a qualified supplier of the Product. 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 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 HSLnext calendar quarter’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 issued in accordance with a Binding 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 acknowledge that the aggregate requirements for 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 Agreement 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, in the 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 way of example through one or more of the 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 each calendar year. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from **** percent (****%) to **** 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 Scoring Year, LMI shall send to HSL a 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 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 compliance” with the methodology for such Scoring Year.

Appears in 1 contract

Sources: Commercial Supply Agreement (Seattle Genetics Inc /Wa)

Forecasts Orders. (i) LMI shall send to HSL a **** (Commencing on the [****) month forecast (*] following the “Initial Forecast”) for the volume execution of Product which LMI expects to have delivered from HSL during such this Agreement, COMPANY shall provide HOVIONE with a rolling [****-month period. LMI *] forecast of COMPANY’s and its Affiliates’ anticipated orders of API for sales of the Product in the Territory, which forecast shall provide the Initial Forecast for Product to HSL within **** (be updated no less than [****) days after HSL is approved as a supplier of Product under *] during the Product NDA. LMI shall thereafter update such forecast at least **** prior to the first business day of each calendar month thereafter Term (a “Subsequent Forecast”, and together with the Initial Forecasteach, a “Forecast”), providing HSL with a rolling **** (. Each Forecast after the first Forecast shall be provided to HOVIONE no later than [****) month forecast for Product. Each Forecast shall include an estimated number *] after the start of Batches for each month during the [****-month period covered by such Forecast*] to assist HOVIONE in planning its production. 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 **** (The [****) months *] of each Forecast shall be binding upon LMI and LMI the remaining [*****] shall be non-binding. COMPANY shall place firm orders for the API using its standard 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 which 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 quantities of Product ordered by LMI. (ii) Subject subject to the terms of this Agreement (including, but not limited to, Sections 5.1, 5.5 and 9.5Agreement), LMI agrees that, during each calendar year setting forth the quantity of this Agreement (with a pro-rata adjustment as applicable for any portion thereof), it shall place orders with HSL for at least **** percent (API required [****%) of *], as well as its aggregate requirements for Product required Delivery Dates, which shall be in the jurisdictions in the Territory where HSL is approved as a qualified supplier of the Product. This requirement shall commence on a country-by-country basis in the Territory on the **** (no event earlier than [****) day after HSL is qualified as a supplier *] from the date of the Product under the applicable regulatory approval in purchase order (any such country and end on the earlier purchase order, a “COMPANY Purchase Order”). HOVIONE will notify COMPANY of its receipt of each COMPANY Purchase Order within [*****] thereafter. Such notice will include confirmation of the termination or expiration Delivery Date, which shall be not less than [*****] from the date of this Agreementthe COMPANY Purchase Order issue date. In addition, this requirement is expressly conditioned upon reasonably acceptable notice If HOVIONE fails to notify COMPANY 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 its receipt of such jurisdiction, LMI’s requirements for COMPANY Purchase Order within 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 issued in accordance with a Forecast[*****] period, the quantities in such purchase order shall COMPANY Purchase Order will be deemed to have been ordered from HSL for purposes received and accepted; provided, however, that if requested by COMPANY in writing, HOVIONE may agree, in its sole discretion, to deliver a shipment of LMI’s requirements for placing orders pursuant to this section. For purposes of clarity, the Parties acknowledge that the aggregate requirements for 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 Agreement extend API prior 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, in the 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 way of example through one or more of the following mechanisms: date that is [****. (iv) LMI shall maintain accurate and complete books and records of its purchases for *] after the jurisdictions in the Territory where HSL is a qualified supplier date of the Product as to enable LMI and its Affiliates to verify their purchases of Product in such jurisdictionsapplicable COMPANY Purchase Order. 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 each calendar year. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from **** percent (Within [****%) *] after a COMPANY Purchase Order issue date, COMPANY may request that additional quantity of API be Manufactured under such COMPANY Purchase Order, such additional quantity to **** percent (be delivered not less than [****%) for *] after the then current Subject YearCOMPANY Purchase Order to which such additional quantity request relates; provided, as if **** percent (that only such additional quantity of API, which shall not be greater than [****%) was set forth in Section 2.2(a)(ii). Within **** (] of the applicable COMPANY Purchase Order [****) days after the end of each Scoring Year*], LMI may be requested unless otherwise agreed to in writing by HOVIONE. HOVIONE shall send use commercially reasonable efforts to HSL a written notice of HSLManufacture any such additional quantity, subject to HOVIONE’s Score for such Scoring Year (including the calculation of same) other supply commitments and a statement as to whether HSL had the highest Scorecapacity. In the event HSL is determined not of any conflict between the provisions of this Agreement and any COMPANY Purchase Order, acknowledgement, invoice, ▇▇▇▇ of lading, acceptance or other preprinted form provided by either Party, the provisions of this Agreement shall control. No additional provision in any other document shall apply unless both Parties explicitly agree in writing that such additional provision shall apply to have the highest ScoreParties rights and obligations under this Agreement. Notwithstanding the above, then, within **** (HOVIONE has agreed to use commercially reasonable efforts to manufacture [****) 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 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 compliance” with the methodology for such Scoring Year.*]

Appears in 1 contract

Sources: Manufacturing Agreement (Anacor Pharmaceuticals, Inc.)

Forecasts Orders. 4.1. No later than ninety (i90) LMI days prior to the anticipated date of first delivery of the first Licensed Product, GALDERMA shall send provide ANIKA with its initial written forecast of GALDERMA’s anticipated requirements for such Licensed Product by SKU for each of the first twelve (12) months following such date of first delivery (such initial forecast and all future forecasts herein referred to HSL as a **** (“Forecast” or the “Forecasts”); provided, however, that such initial Forecast shall not provide for delivery of more than [****) month forecast (the “Initial Forecast”) for the volume of Product which LMI expects to have delivered from HSL during such ****-month period. LMI shall provide the Initial Forecast for Product to HSL within **** (****) days after HSL is approved as a supplier of Product under the Product NDA. LMI shall thereafter update such forecast at least **** *] Units of such Licensed Product per month in the first [****************] 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 the first business day commencement of each calendar month thereafter (a “Subsequent Forecast”during the Term, and together with the Initial Forecast, a “Forecast”), providing HSL GALDERMA shall provide ANIKA with a rolling **** 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) [****) 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 **** (********] of the first and second months, (ii) months [****************] of the third and fourth months, and (iii) [****************] of the fifth and sixth months, in each case shall 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 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 [*****] Units or more than [******] Units. Each Forecast will indicate the delivery dates for the Licensed Products, and the delivery dates for the first [*******************] will be binding upon LMI and LMI shall place purchase orders corresponding on the 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 portion commitment incurred pursuant to each Forecast pursuant to Section 4.1, GALDERMA shall 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 applicable Forecast with respect to the first and second months of such Forecast, [************] by SKU by month of such Forecast with respect to the third and fourth months, and [**********] by SKU by month of such Forecast with respect to the fifth and sixth months (the “Purchase Orders”). In the event LMI does not place purchase orders against If GALDERMA requests a quantity of Licensed Product that exceeds the binding portion of a given Forecast, HSL may (but the Parties agree in good faith to negotiate additional quantities and associated delivery dates. The Purchase Orders shall not be required to) deem such binding Forecast as a purchase order for Product covered by designate the binding portion of the Forecast. HSL will use all commercially reasonable efforts to accommodate any changes in desired SKU’s and quantities of Product ordered by LMI. Licensed Products (ii) Subject subject to the terms requirements of this Agreement (including, but not limited to, Sections 5.1, 5.5 and 9.5Section 4.2), LMI agrees that, during each calendar year delivery dates (subject to the last sentence of this Agreement (with a pro-rata adjustment as applicable for any portion thereof), it Section 4.1) and destinations. The minimum Purchase Order quantity by SKU shall place orders with HSL for at least **** percent (be [****%) of its aggregate requirements for Product in the jurisdictions in the Territory where HSL is approved as a qualified supplier of the Product. This requirement shall commence on a country-by-country basis in the Territory on the **** (*********] Units. GALDERMA shall issue written Purchase Orders for Licensed Products to ANIKA at least sixty (60) day after HSL is qualified as a supplier of days prior to the 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 HSLrequested delivery dates. 4.3. In the event HSL cannot fill a purchase that GALDERMA shall fail to place sufficient Purchase Orders to satisfy the binding order issued in accordance with a commitment incurred pursuant to any Forecast, the quantities in such purchase order Purchase Orders shall be deemed to have been ordered from HSL for purposes submitted by GALDERMA, and ANIKA shall deliver such Licensed Products to GALDERMA. 4.4. To the extent of LMI’s requirements for placing orders pursuant to any conflict or inconsistency between this section. For purposes of clarityAgreement and any Purchase Order, purchase order release, confirmation, acceptance or any similar document, the Parties acknowledge that the aggregate requirements for 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) terms of this Agreement extend to the books and records of both LMI and its Affiliatesshall govern. (iii) Without limiting HSL’s remedies in the event of a breach of the preceding paragraph, in the 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 way of example through one or more of the 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 each calendar year. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from **** percent (****%) to **** 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 Scoring Year, LMI shall send to HSL a 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 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 compliance” with the methodology for such Scoring Year.

Appears in 1 contract

Sources: Supply Agreement (Anika Therapeutics Inc)

Forecasts Orders. (i) LMI shall send 3.1 Initial Forecast for Products. Prior to HSL a the Effective Date, Manufacturer provided Confidential Information indicated by [**** (] has been omitted from this filing and filed separately with the Securities Exchange Commission. Purchaser with Seller’s forecast of finished Product for Distribution in the United States during the [****) month forecast ] period beginning on the Effective Date, including the Product packaging schedule based on existing purchase orders (the “Initial Forecast”). The first (1st) for the volume of Product which LMI expects to have delivered from HSL during such [****-month period. LMI shall provide ] of the Initial Forecast for Product to HSL within **** (****) days after HSL is approved as a supplier of Product under the Product NDA. LMI shall thereafter update such forecast at least **** prior to the first 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 on Purchaser, meaning that Purchaser shall place purchase orders corresponding to the binding portion all quantities of stock keeping units produced in accordance with 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 Initial Forecast as a purchase order reasonably required for Product covered by the binding portion forecasted quantities of Products for such [***] period. Within [***] after the Forecast. HSL will Effective Date, Purchaser shall provide Manufacturer with an updated Initial Forecast and Manufacturer shall use all commercially reasonable efforts to accommodate any meet such updated Initial Forecast; provided, however, no changes in quantities shall be made to the first [***] of Product ordered by LMIthe Initial Forecast. 3.2 Updated Rolling Forecast for Products. (iia) Subject Beginning [***], Purchaser shall provide to Manufacturer, no later than [***], an updated forecast of its requirements of Products for Distribution in the United States during the following [***] period (the “Rolling Forecast”) starting with the month following the month during which such Rolling Forecast was provided. (b) The Rolling Forecast shall be 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 Rolling Forecast shall be binding (the “Binding Period”). The forecast for the Binding Period shall be provided in monthly quantities of number of packs of stock keeping units. The [***] Quarters of the Rolling Forecast shall be semi-binding (the “Semi-Binding Period”), meaning that, in the next Rolling Forecast, Purchaser may increase or decrease the quantities forecasted [***] Manufacturer shall use commercially reasonable efforts to plan the manufacture of Products to meet Purchaser’s forecast for the Semi-Binding Period. The forecast for the Semi-Binding Period shall be 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 “Non-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 acknowledge and agree that Manufacturer’s application to the terms of this Agreement (including, but not limited to, Sections 5.1, 5.5 and 9.5), LMI agrees that, during DEA for DEA Procurement Quota for each calendar year of this Agreement will be based on Purchaser’s Forecast for Products for distribution in the United States for such calendar year and Seller’s (with and its Affiliates’) forecasts for Seller Products for distribution outside the United States for such calendar year. Promptly after the DEA grants a pro-rata adjustment as applicable 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 thereof), it shall place orders with HSL for at least of such Confidential Information indicated by [**** percent ] has been omitted from this filing and filed separately with the Securities Exchange Commission. DEA Procurement Quota allocated to Purchaser (****%) of its aggregate requirements for Product such portion, the “Purchaser DEA Procurement Quota”). Notwithstanding anything to this contrary in this Section 3.2, the quantities set forth in the jurisdictions in Rolling Forecast shall not exceed the Territory where HSL is approved as a qualified supplier Purchaser DEA Procurement Quota for the applicable calendar year. If, after Manufacturer notifies Purchaser of the ProductPurchaser 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. This requirement Any requested increases to the DEA Procurement Quota, DEA Manufacturing Quota and DEA Aggregate Production Quota shall commence on a country-by-country basis in be subject to the Territory on the **** (****) day after HSL is qualified as a supplier approval of the Product under the applicable regulatory approval in such country DEA 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 issued sought in accordance with a ForecastDEA 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 quantities additional API needed for such additional Product) to satisfy the increase in such purchase order shall be deemed the Purchaser DEA Procurement Quota, and (iii) Purchaser may update the Rolling Forecast to have been ordered from HSL for purposes of LMI’s requirements for placing orders pursuant to this sectionreflect the increased Purchaser DEA Procurement Quota. For purposes the sake of clarity, in no event shall Manufacturer be required to apply any portion of the Parties acknowledge that the aggregate requirements for 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 Agreement extend DEA Procurement Quota to the books and records manufacture of both LMI and its AffiliatesProducts for Purchaser other than the Purchaser DEA Procurement Quota. (iiic) Without limiting HSL’s remedies in During the event of a breach period prior to the effective date of the preceding paragraph, in the event LMI fails to order the requirements set forth above the Parties may discuss and agree on making HSL whole (including recovery of lost profitslabel change contemplated by Section 1.1(c), such as by way Purchaser and Manufacturer shall cooperate to minimize the number of example through one or more 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 following mechanisms: ****Binding Periods and Semi-Binding Periods and Purchase Orders with quantities below the Minimum Order Quantity. (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 each calendar year. For each calendar year from and after the calendar year in which HSL commences commercial manufacturing of the Product pursuant to Section 2.2(a)(ii) (each a “Subject Year”) if in the 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 minimum percentage requirement of Section 2.2(a)(ii) of this Agreement relating to such Product shall increase from **** percent (****%) to **** 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 Scoring Year, LMI shall send to HSL a 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 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 compliance” with the methodology for such Scoring Year.

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Sources: Transitional Supply Agreement