Common use of Supply of Product Clause in Contracts

Supply of Product. 4.1 DAEWOONG shall manufacture and supply Product to AEON in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

Appears in 4 contracts

Samples: License & Supply Agreement (AEON Biopharma, Inc.), License & Supply Agreement (AEON Biopharma, Inc.), License & Supply Agreement (AEON Biopharma, Inc.)

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Supply of Product. 4.1 DAEWOONG (a) Subject to Section 5.7, for the term of this Agreement, Alamo agrees to purchase from CIMA and CIMA agrees to supply Alamo with all of Alamo’s requirements for the Product, Product samples and Product placebos for their subsequent use, sale, offer for sale, lease or transfer by Alamo. Alamo shall manufacture be responsible for procurement of API or require, upon reasonable notice, CIMA to procure all API necessary for the satisfaction of its obligations under this Agreement. If Alamo procures the API necessary for CIMA to perform the supply activities described in this Section 5.1, then Alamo shall pay CIMA ***% of the API cost (net of any rebates, credits or refunds) for CIMA’s costs and expenses for handling the API. If CIMA, at Alamo’s request, procures the API necessary for CIMA to perform the supply activities described in this Section 5.1, then Alamo shall reimburse CIMA for CIMA’s certified direct out-of-pocket costs plus *** percent (***%) (net of any rebates, credits or refunds) for the acquisition of the API. (b) Alamo agrees to initiate purchases of the Product, Product to AEON in a primary packaged samples and labeled form. Product packaging shall display the logo of DAEWOONG (placebos hereunder by issuing CIMA binding purchase orders not less than 90 days prior to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is shipping date set forth in Annex D. Within ninety (90) days therein. In addition, after the Effective Date, AEON shall provide DAEWOONG with a non-binding twelve (12) month rolling period following Launch in any Region, Alamo will also provide a 180 day forecast of its requirements of Productthat is 60% binding for the next ninety (90) day period (i.e. if the forecast shows 100 units in each quarter, which then the Parties agree first 100 is not a commitment 100% binding, second quarter is 60% binding or Alamo can reduce to buy 60 units). CIMA agrees to accept any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product order issued in accordance with this Section 5.1(b) and to meet the forecasting requirements delivery dates specified therein so long as at the time of receiving the purchase order, all artwork, API and other responsibilities of Alamo are delivered in Article 4.2fine form to CIMA. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it All purchase orders hereunder shall be considered on Alamo’s standard purchase order form (a copy of which is attached as irrevocable. 4.5 AEON agrees herein Schedule D hereto and which shall not, for purposes of this Agreement only, be modified in any material respect without CIMA’s prior written consent, such consent not to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product be unreasonably withheld or delayed) and shall be placed directed to CIMA at least [***] in advance the address set forth below. The terms and conditions of purchase enumerated on the required delivery date. 4.7 For the purpose reverse side of Commercializationsuch standard purchase order form shall prevail over any inconsistent or conflicting language as may exist on invoices, AEON will store and maintain the full quantity confirmation or order acknowledgment forms of Product in a cleanCIMA, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof provided, however, that in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations event any terms thereof are in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agentsconflict, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON or are inconsistent with the any terms of this Agreement, including without limitation the terms and conditions hereof shall prevail. No Product delivered by CIMA shall have a shelf life that is more than six (a6) months less than the holding facilities maximum shelf life of such product; and, in any case, all Product delivered by CIMA shall have no more than 6 month into the regulatory approved expiry date of shelf life remaining upon delivery to Alamo. CIMA will use reasonable efforts to deliver to Alamo Product with more than eighteen (18) months of shelf life if possible. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. (c) Purchase order quantities shall be equivalent to the batch size of the Product, Product samples or Product placebos which shall be determined during the development activities, approximately *** tablets for the 25 mg dose, and (b) AEON’s compliance with applicable law*** tablets for the 100 mg dose, including cGMP (if applicable)in the aggregate for any single purchase order, unless otherwise mutually agreed by the parties. Following The delivery quantity of tablets for trade shall not exceed a total of *** batches in any such auditone calendar month, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be unless otherwise agreed upon to by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition (d) Purchase orders shall clearly state that the order is for tablets for sale, tablets for samples or placebos, as well as the shipping destination and address. Alamo and CIMA will work together to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes agree on reasonable quantities of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON tablets for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third partiessamples if needed. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

Appears in 2 contracts

Samples: Development, License and Supply Agreement (Azur Pharma Public LTD Co), Development, License and Supply Agreement (Azur Pharma Public LTD Co)

Supply of Product. 4.1 DAEWOONG shall manufacture (a) During the term of this Agreement, KU agrees to order and supply Product to AEON in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language purchase Products exclusively from Alkermes in accordance with applicable laws the batch sizes and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is minimum order quantities set forth in Annex D. Within ninety (90) days after the Effective Date, AEON shall provide DAEWOONG Schedule 4.1 and Alkermes agrees to supply Products exclusively to KU. Alkermes will supply KXJ with a non-binding twelve (12) month rolling forecast all of its requirements for Products and the Products samples for their subsequent use, sale, lease or transfer by KU. (b) KU agrees to initiate purchases of Product, which Products and samples of the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product Products hereunder by issuing Alkermes purchase orders in accordance with the forecasting requirements set forth in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product Schedule 4.1 not later less than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization]. Subject to Section 4.1(c), AEON will store and maintain the full quantity of Product in a clean, secured area Alkermes agrees to accept any order issued in accordance with this Section 4.1(b) which specifies quantities reasonably consistent with those set forth in the reasonable directions purchase forecasts for such Quarter and specifications to meet the delivery dates specified thereon. All purchase orders hereunder shall be on KU’s standard purchase order form (a copy of which has been delivered to Alkermes) and shall be directed to Alkermes at the address set forth below. KU shall maintain at all times inventory of the Product in the ordinary course. (c) The Parties shall reasonably cooperate with respect to Product production schedules. In particular, the parties will routinely review through then supply teams the 18 month forecast provided by DAEWOONG KU in writing accordance in connection thereof in the TerritorySection 4.3 below and Alkermes shall advise KU of any scheduling conflicts. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees If KU submits any purchase order for Branded V Product with a delivery date or dates that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON are not aligned with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon Alkermes’ overall production schedule as discussed by the Partiessupply teams with respect to the 18 month forecast, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON then Alkermes shall have the right to recover lost profits in reject such purchase order. Alkermes shall not, however, reject any purchase order for Branded V Product submitted by KU with a delivery date or dates that are aligned with such production schedule, as discussed by the event Parties’ supply teams. (d) Alkermes shall use commercially reasonable efforts to maximize the life of the Products supplied to KU pursuant to this Agreement; provided that DAEWOONG fails to deliver such Products shall have at least a [***] in ]. If any Product that is to be delivered to KU will have a shelf life of less than [***] (a “Supply Default Event”). For purposes ], then Alkermes shall notify KU prior to shipment of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default EventProduct, and every [***] thereafterAlkermes and KU shall discuss in good faith the disposition of such Product. AEON agrees If Alkermes and KU are not able to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending reach agreement on the first day disposition of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for such Product, DAEWOONG shall allocate then such Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject shipped to Article 7KU.

Appears in 2 contracts

Samples: License and Supply Agreement (Lannett Co Inc), License and Supply Agreement (Recro Pharma, Inc.)

Supply of Product. 4.1 DAEWOONG 12.1 Astra shall manufacture and supply Product to AEON notify Salix in a primary packaged and labeled form. Product packaging shall display the logo writing of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales its forecast requirements for quantities of the Product during the Term of Agreement (in the Territory in the Field is set forth in Annex D. Within ninety (90form of bulk filled capsules and including Product to be used as samples) days after the Effective Date, AEON and details of its proposals for Launch twelve months prior to its expected Launch. With such forecast Astra shall provide DAEWOONG with deliver a non-binding twelve (12) month rolling detailed forecast of its requirements for the Product for the twelve month period from the date of Product, which the Parties agree is not a commitment to buy any stated quantitysuch notice. Thereafter, Astra shall, on at least a quarterly basis, AEON deliver to Salix revised forecasts for the subsequent 12 month period commencing on the subsequent April 1st, July 1st, October 1st and January 1st respectively. Astra's ambition is to provide Salix with forecasts indicating Astra's expected requirements per month. 12.2 Salix shall provide DAEWOONG with an updated twelve (12) month rolling forecastfulfill all written orders placed on it by Astra for the Product in the form of bulk filled capsules, together with a binding six (6) month forecast subject to the extent AEON has requested Safety Stock as described in provisions of Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port12.3. 4.4 Once a Purchase Order for Product and Product Samples has been received 12.3 Whilst the forecasts delivered by DAEWOONG, it Astra to Salix under Article 12.1 shall be considered as irrevocablenon-binding and will not place any obligation on either Astra to order such quantities or Salix to deliver such quantities: [*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 4.5 AEON agrees herein 12.3.1 Astra shall use all reasonable endeavors to place an Order estimate accurately in such forecasts its requirements for Product not later than [***] from receipt of Regulatory Approval.the Product; and 4.6 Individual Purchase Orders of Product 12.3.2 Astra shall be ensure that all written orders are placed at least [***] in advance permitting a lead time for manufacturing of the required delivery date.Product of not less than 16 weeks; and 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product 12.3.3 Astra acknowledges that Salix shall not be obliged to fulfil any firm written orders placed on it that may be in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least excess [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, last forecast quantities (in accordance with Article 12.1) for such period; and 12.3.4 Astra shall place written orders and every accept delivery of quantities of the Product that are not less [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month last forecast quantities (in which accordance with Article 12.1) for such period. 12.4 Salix shall supply Astra with such quantities of the Supply Event Default occurredProduct as Astra may reasonably require (in bulk filled capsule form) for clinical trials undertaken by Astra hereunder. In Astra shall endeavor to provide Salix with the maximum period of notice of such requirements and in any event shall place firm written orders on Salix therefore not less than 60 days before any requested delivery date, provided that DAEWOONG is unable failure of Salix to deliver sooner than within 90 days shall not constitute breach under this Agreement. 12.5 Salix shall supply both AEON’s requirements Astra with such quantities of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of the Product in priority to DAEWOONG bulk filled capsule form as Astra shall reasonably require for use as product samples and third partiesas shall have been forecasted and ordered by Astra in accordance with Articles 12.1 and 12. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

Appears in 1 contract

Samples: Co Participation Agreement (Salix Holdings LTD)

Supply of Product. 4.1 DAEWOONG shall manufacture and supply Product to AEON EVOLUS in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON EVOLUS and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON EVOLUS shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON EVOLUS shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON EVOLUS has requested Safety Stock as described in Article Section 4.10 below. Each such forecast shah shall be referred to herein as a “Forecast. 4.3 AEON EVOLUS may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON EVOLUS agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON EVOLUS will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON EVOLUS will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON EVOLUS agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s EVOLUS’ facility to ascertain compliance by AEON EVOLUS with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s EVOLUS’ compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON EVOLUS and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON EVOLUS using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEONEVOLUS, AEON EVOLUS shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON EVOLUS operating profit (sales less direct expenses and the puce price paid by AEON EVOLUS for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event Event, and bona fide Purchase Orders submitted by AEON EVOLUS that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.defined

Appears in 1 contract

Samples: License & Supply Agreement (Evolus, Inc.)

Supply of Product. 4.1 DAEWOONG (a) Supply for the Clinical Study. SANQUIN shall manufacture and supply all Product to AEON in a primary packaged and labeled form. Product packaging shall display necessary for the logo of DAEWOONG (Clinical Study, but limited to the extent required by applicable law) and AEON and maximum aggregate amount of * units, supplies being divided in time as follows:. SANQUIN shall supply at least * units as soon as possible after SANQUIN is able to obtain an export license for the outer label Product, but no later than July 1, 2005. SANQUIN shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast also provide an additional amount of the Product during the Term so that a total of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date* units are delivered to LEVPHARMA no later than July 1, AEON 2005. SANQUIN shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Productan additional * Units to LEVPHARMA by December 31, which the Parties agree is not a commitment to buy any stated quantity2005. Thereafter, on the Parties shall agree to a timetable for the manufacture and delivery of the remaining * Units. SANQUIN shall provide the Product for the Clinical Study in a form and in packaging as required by LEVPHARMA necessary to complete the Clinical Study. Such packaging shall include all materials needed to infuse the Product or placebo. However, LEVPHARMA shall be responsible for identifying at least a quarterly basisthree different FDA-approved vendors, AEON acceptable to SANQUIN, for such materials, i.e. suitable water for injection and all other accessories needed, and obtaining quotations from such which vendors to be submitted to SANQUIN for SANQUIN to negotiate and select an appropriate vendor at SANQUIN's cost. Such Product shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product supplied by SANQUIN in accordance with the forecasting requirements Clinical Specifications and Manufacturing Standards as described in Article 4.2Section 4.1(e) below and in accordance with forecasts provided by LEVPHARMA after the Regulatory Filing has been filed with the FDA for said Clinical Study, which forecasts shall not exceed the delivery schedule outlined above. Orders will be shipped on CIF Los Angeles portSANQUIN shall invoice LEVPHARMA for the Clinical Product according to the terms outlined in Section 5.2(a). 4.4 Once a Purchase Order (b) Placebo for Product and Product Samples has been received by DAEWOONGthe Clinical Study. LEVPHARMA shall, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions needs pursuant to the protocol for the Clinical Study, obtain suitable placebo from a third party at LEVPHARMA's responsibility and specifications provided by DAEWOONG cost. LEVPHARMA shall provide SANQUIN with such placebo free of charge and SANQUIN shall package the placebo in writing in connection thereof a way similar to the Product to be used in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for ProductClinical Study, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations shall deliver the labeled and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Effortspackaged placebo according to LEVPHARMA's requirements. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

Appears in 1 contract

Samples: Distribution and Manufacturing Services Agreement (Lev Pharmaceuticals Inc)

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Supply of Product. 4.1 DAEWOONG 9.1 Astra shall manufacture and supply Product to AEON notify Glycyx in a primary packaged and labeled form. Product packaging shall display the logo writing of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales its forecast requirements for quantities of the Product during the Term of Agreement (in the Territory form of bulk filled capsules) and details of its proposals for Launch in each of the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON Principal Markets on or before June 30th 1993. With such forecast Astra shall provide DAEWOONG with deliver a non-binding twelve (12) month rolling detailed forecast of its requirements for the Product during 1994 and in January, April, July and October in each year shall deliver to Glycyx revised forecasts for the subsequent 12 month period commencing on the subsequent April 1st, July 1st, October 1st and January 1st respectively. 9.2 Glycyx shall fulfill all written orders placed on it by Astra for the Product in the form of bulk filled capsules. 9.3 Whilst the forecasts delivered by Astra to Glycyx under Clause 9.1 shall be non-binding and will not place any obligation on either Astra to order such quantities or Glycyx to deliver such quantities:- 9.3.1 Astra shall use all reasonable endeavours to estimate accurately in such forecasts its requirements for the Product, which ; and 9.3.2 Astra shall ensure that all written orders are placed permitting a lead time for manufacturing of the Parties agree is Product of not a commitment less than 16 weeks; and 9.3.3 Astra acknowledges that Glycyx shall not be obliged to buy fulfill any stated quantityfirm written orders placed on it that may be in excess of [*] of the last forecast quantities (in accordance with Clause 9.1) for such period; and 9.3.4 Astra undertakes to place written orders and accept delivery of quantities of the Product that are not less than [*] of the last forecast quantities (in accordance with Clause 9.1) for such period. 9.4 During the term of the Research Agreement Glycyx shall supply Astra with such quantities of the Product as Astra may reasonably require (in bulk filled capsule form) for clinical trials undertaken by Astra under the terms of the Research Agreement. Thereafter, Astra shall endeavour to provide Glycyx with the maximum period of notice of such requirements and in any event shall place firm written orders on Glycyx therefor not less than 90 days before any requested delivery date. 9.5 After the termination of the Research Agreement Glycyx shall supply Astra with such quantities of the Product in bulk filled capsule form as Astra shall reasonably require for use as product samples and clinical trial samples and as shall have been forecast and ordered by Astra in accordance with Clauses 9.1 to 9.3. 9.6 Glycyx hereby warrants and undertakes that all quantities of the Product (in bulk filled capsule form) supplied by it to Astra under the terms of this Agreement shall as at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah date of delivery be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product supplied fully in accordance with the forecasting requirements Bulk Product Specification and the Finished Product Specification contained in Article 4.2. Orders will be shipped on CIF Los Angeles portSchedule 3 and shall have been manufactured in accordance with European Community Good Manufacturing Practice and the Drug Master File for the Product. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product not later than [***] from 9.7 Upon the receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance any delivery of the required delivery date. 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area from Glycyx Astra shall test such Product (in accordance with the reasonable directions Quality Test Procedures to be agreed and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject incorporated into Schedule 4 to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms this Agreement after execution of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails such Quality Test Procedures reveal any breach of the warranty given in Clause 9.6 Astra shall be entitled to deliver at least reject the full shipment of the Product within 45 days of receipt of such shipment by notice in writing to Glycyx. 9.8 In the event of any dispute between the parties concerning any allegation of breach of the warranty contained in clause 9.6 or concerning any rejection or purported rejection of [***] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. any shipment of the Product a sample quantity of the Product in any [***] question shall (a “Supply Default Event”). For purposes at the joint cost and expense of this provisionthe parties) be delivered to an independent laboratory (nominated by the agreement of the parties or in the absence of agreement on the application of either party by the President for the time being of the Royal Pharmaceutical Society of Great Britain) which shall be supplied with copies of the Bulk Product Specification, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses the Finished Product Specification and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during Drug Master File and shall carry out testing in accordance with the period leading up Quality Test Procedures and whose decision as to the Supply Default Event quality of such Product and bona fide Purchase Orders submitted as to any breach of warranty by AEON that are consistent with such Product, shall in the Forecast during absence of manifest error be final and binding on the Supply Default Period (as defined below). Such payment parties. 9.9 The terms and conditions relating to the supply of the Product by Glycyx to Astra shall be made with respect as set out in this Agreement and each written order placed on Glycyx by Astra shall form a separate contract for the supply of the Product. 9.10 The parties undertake to all execute an agreement relating to the manufacture and supply of Product not shipped for the purpose of disclosure to the relevant regulatory authorities in the period giving rise to Territory substantially in the Supply Default and for form contained in Schedule 4 on or before the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurredFiling Date. In the event that DAEWOONG such agreement is unable entered into by any Astra Associate in place of Astra Astra undertakes to supply both AEON’s requirements guarantee and procure the proper performance by such Astra Associate of Product and all its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third partiesobligations under such agreement. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

Appears in 1 contract

Samples: Distribution Agreement (Salix Holdings LTD)

Supply of Product. 4.1 DAEWOONG shall manufacture and supply Product to AEON EVOLUS in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON EVOLUS and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON EVOLUS shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON EVOLUS shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON EVOLUS has requested Safety Stock as described in Article Section 4.10 below. Each such forecast shah shall be referred to herein as a “Forecast. 4.3 AEON EVOLUS may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON EVOLUS agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON EVOLUS will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON EVOLUS will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON EVOLUS agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s EVOLUS’ facility to ascertain compliance by AEON EVOLUS with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s EVOLUS’ compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON XXXXXX and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON EVOLUS using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEONEVOLUS, AEON EVOLUS shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON EVOLUS operating profit (sales less direct expenses and the puce price paid by AEON EVOLUS for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event Event, and bona fide Purchase Orders submitted by AEON EVOLUS that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s EVOLUS’ needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON XXXXXX agrees to permit full disclosure to DAEWOONG of AEON’s EVOLUS’ accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s EVOLUS’ requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Productproduce, so that AEON EVOLUS receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEONEVOLUS, DAEWOONG shall at its own cost and expense during the Termterm of this Agreement, maintain an amount of inventory of Product equal to AEON’s EVOLUS’ requirements for Product for [***] based on AEON’s EVOLUS’ most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON EVOLUS and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

Appears in 1 contract

Samples: License & Supply Agreement (Evolus, Inc.)

Supply of Product. 4.1 DAEWOONG shall manufacture and supply Product to AEON EVOLUS in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON EVOLUS and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON EVOLUS shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON EVOLUS shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON EVOLUS has requested Safety Stock as described in Article Section 4.10 below. Each such forecast shah shall be referred to herein as a “Forecast. 4.3 AEON EVOLUS may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON EVOLUS agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON EVOLUS will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON EVOLUS will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON EVOLUS agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s EVOLUS’ facility to ascertain compliance by AEON EVOLUS with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s EVOLUS’ compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON EVOLUS and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON EVOLUS using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEONEVOLUS, AEON EVOLUS shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON EVOLUS operating profit (sales less direct expenses and the puce price paid by AEON EVOLUS for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event Event, and bona fide Purchase Orders submitted by AEON EVOLUS that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s EVOLUS’ needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON EVOLUS agrees to permit full disclosure to DAEWOONG of AEON’s EVOLUS’ accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s EVOLUS’ requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Productproduce, so that AEON EVOLUS receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEONEVOLUS, DAEWOONG shall at its own cost and expense during the Termterm of this Agreement, maintain an amount of inventory of Product equal to AEON’s EVOLUS’ requirements for Product for [***] based on AEON’s EVOLUS’ most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON EVOLUS and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

Appears in 1 contract

Samples: License & Supply Agreement (Evolus, Inc.)

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