Forecasts and Orders. 7.3.1 Not less than [*****] days prior to the first day of each calendar quarter (commencing with the first calendar quarter in which Intrexon, its sublicensees or their respective Affiliates order API from Halozyme hereunder), Intrexon shall prepare and provide Halozyme with a written forecast of its good faith estimated requirements for API under this Section 7.3 for each of the subsequent [*****] calendar quarters. Intrexon shall not (a) increase or decrease the quantity estimated for the [*****] quarterly period of each forecast from the quantity estimated for the [*****] quarterly period of the previous forecast, (b) increase or decrease the quantity estimated for the [*****] quarterly periods of each forecast by more than [*****] percent ([*****]%) of the quantity estimated for the [*****] quarterly periods of the previous forecast, respectively, without the prior express written consent of Halozyme. The quantities estimated for the [*****] quarterly periods of each forecast shall be non-binding, and for planning purposes only. 7.3.2 Intrexon shall be required to purchase [*****] of the quantity forecasted for each API under this Section 7.3 for the first and second quarterly periods of each forecast under Section 7.3.1. 7.3.3 Halozyme shall be required to supply the quantity of API ordered by Intrexon under this Section 7.3 in any calendar quarter up to [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast. If Intrexon’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter exceed [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast, Halozyme shall use commercially reasonable efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet Intrexon’s delivery requirements specified in accordance with Section 7.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon and its other customers on a pro rata basis according to their respective forecasts. 7.3.4 Intrexon shall make all purchases under this Section 7.3 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement shall prevail.
Appears in 3 contracts
Sources: Collaboration and License Agreement (Intrexon Corp), Collaboration and License Agreement (Intrexon Corp), Collaboration and License Agreement (Intrexon Corp)
Forecasts and Orders. 7.3.1 Not less than [*** (*****] ) days prior to the first day of each calendar quarter (commencing with the first calendar quarter in which IntrexonViroPharma, its sublicensees or their respective Affiliates order API from Halozyme hereunder), Intrexon ViroPharma shall prepare and provide Halozyme with a written forecast of its good faith estimated requirements for API under this Section 7.3 for each of the subsequent [*** (*****] ) calendar quarters. Intrexon ViroPharma shall not (a) increase or decrease the quantity estimated for the [*****] * quarterly period of each forecast from the quantity estimated for the [*****] * quarterly period of the previous forecast, (b) increase or decrease the quantity estimated for the [*****] * quarterly periods of each forecast by more than [*** percent (*****] percent ([*****]%) of the quantity estimated for the [*****] * quarterly periods of the previous forecast, respectively, without the prior express written consent of Halozyme. The quantities estimated for the [*****] * quarterly periods of each forecast shall be non-binding, and for planning purposes only.
7.3.2 Intrexon ViroPharma shall be required to purchase [*** (*****] %) of the quantity forecasted for each API under this Section 7.3 for the first and second quarterly periods of each forecast under Section 7.3.1.
7.3.3 Halozyme shall be required to supply the quantity of API ordered by Intrexon ViroPharma under this Section 7.3 in any calendar quarter up to [*** percent (*****] percent ([*****]%) of the quantity forecasted for the [*****] * quarterly period of the most recent forecast. If IntrexonViroPharma’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter exceed [*** percent (*****] percent ([*****]%) of the quantity forecasted for the [*****] * quarterly period of the most recent forecast, Halozyme shall use commercially reasonable efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet IntrexonViroPharma’s delivery requirements specified in accordance with Section 7.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon ViroPharma and its other customers on a pro rata basis according to their respective forecasts.
7.3.4 Intrexon ViroPharma shall make all purchases under this Section 7.3 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*** (*****] ) days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement shall prevail.
Appears in 3 contracts
Sources: Collaboration and License Agreement, Licensing Agreement, Collaboration and License Agreement (Viropharma Inc)
Forecasts and Orders. 7.3.1 6.3.1 Not less than [*****] one hundred eighty (180) days prior to the first day of each calendar quarter (commencing with the first calendar quarter in which IntrexonB▇▇▇▇▇, its sublicensees or their respective Affiliates order API from Halozyme hereunder), Intrexon B▇▇▇▇▇ shall prepare and provide Halozyme with a written forecast of its good faith estimated requirements for API under this Section 7.3 6.3 for each of the subsequent [*****] six (6) calendar quarters. Intrexon B▇▇▇▇▇ shall not (a) increase or decrease the quantity estimated for the [*****] first quarterly period of each forecast from the quantity estimated for the [*****] second quarterly period of the previous forecast, or (b) increase or decrease the quantity estimated for the [*****] second and third quarterly periods of each forecast by more than [*** (*****] percent ([*****]%) of the quantity estimated for the [*****] third and fourth quarterly periods of the previous forecast, respectively, without the prior express written consent of Halozyme. The quantities estimated for the [*****] fifth and sixth quarterly periods of each forecast shall be non-binding, and for planning purposes only.
7.3.2 Intrexon 6.3.2 B▇▇▇▇▇ shall be required to purchase [*****] one hundred percent (100%) of the quantity forecasted for each API under this Section 7.3 6.3 for the first and second quarterly periods of each forecast under Section 7.3.16.3.1.
7.3.3 6.3.3 Halozyme shall be required to supply the quantity of API ordered by Intrexon B▇▇▇▇▇ under this Section 7.3 6.3 in any calendar quarter up to [*** percent (*****] percent ([*****]%) of the quantity forecasted for the [*****] first quarterly period of the most recent forecast. If Intrexon’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. B▇▇▇▇▇’▇ orders in any calendar quarter exceed [*** percent (*****] percent ([*****]%) of the quantity forecasted for the [*****] first quarterly period of the most recent forecast, Halozyme shall use commercially reasonable good faith efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet Intrexon’s B▇▇▇▇▇’▇ delivery requirements specified in accordance with Section 7.3.46.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon B▇▇▇▇▇ and its other customers on a pro rata basis according to their respective forecasts.
7.3.4 Intrexon 6.3.4 B▇▇▇▇▇ shall make all purchases under this Section 7.3 6.3 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] sixty (60) days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement shall prevail. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission.
Appears in 1 contract
Sources: Enhanze™ Technology License and Collaboration Agreement (Halozyme Therapeutics Inc)
Forecasts and Orders. 7.3.1 7.7.1. Not less than [*****] days prior to the first day of each calendar quarter Calendar Quarter (commencing with the first calendar quarter Calendar Quarter in which Intrexon, its sublicensees or their respective Affiliates order API IMMEDICA orders Product from Halozyme the LICENSOR hereunder), Intrexon IMMEDICA shall prepare and provide Halozyme the LICENSOR with a written forecast of its good faith estimated requirements for API under this Section 7.3 Product for each of the subsequent [*****] calendar quarters(each a “Forecast”). Intrexon IMMEDICA shall not (a) increase or decrease the quantity estimated for the [*****] quarterly period of each forecast Forecast from the quantity estimated for the [*****] quarterly period of such periods in the previous forecast, (b) increase or decrease the quantity estimated for the [*****] quarterly periods of each forecast by more than [*****] percent ([*****]%) of the quantity estimated for the [*****] quarterly periods of the previous forecast, respectively, without the prior express written consent of HalozymeForecast. The quantities estimated for the [*****] quarterly periods all subsequent Calendar Quarters of each forecast Forecast shall be non-binding, and for planning purposes only. By way of example, if IMMEDICA issues a forecast on [*], [*] shall be binding on the Parties and the forecasts for [*] shall not be binding on the Parties. In addition, IMMEDICA will provide on a country-by-country basis its good faith estimated number of patients to be treated in the Forecast for the purposes of LICENSOR providing dosimetric doses of the Product. LICENSOR will supply dosimetric doses based on such Forecast of the Product in a manner it reasonably believes most efficient, provided however, it will ensure that dosimetric doses are supplied to all identified patients in accordance with the terms of this Agreement. Therapeutic doses of the Product will be supplied on a per patient basis pursuant to the terms of this Agreement.
7.3.2 Intrexon shall be required to purchase [*****] of the quantity forecasted for each API under this Section 7.3 for the first and second quarterly periods of each forecast under Section 7.3.1.
7.3.3 Halozyme 7.7.2. The LICENSOR shall be required to supply the quantity of API Product ordered by Intrexon IMMEDICA under this Section 7.3 7.7 in any calendar quarter Calendar Quarter up to [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecastForecast in a manner that is reasonably practical given the nature of the Product. If IntrexonIMMEDICA’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter Calendar Quarter exceed [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecastForecast, Halozyme the LICENSOR shall use commercially reasonable efforts to supply such excess. Halozyme The LICENSOR shall use commercially reasonable efforts to meet IntrexonIMMEDICA’s delivery requirements specified in accordance with Section 7.3.47.7.3. In the event of a shortfall to forecastshortfall, Halozyme the LICENSOR shall promptly inform IMMEDICA and use commercially reasonable efforts Commercially Reasonable Efforts to apportion API Product among Intrexon IMMEDICA, the LICENSOR, and its other customers on a pro rata basis [*] according to their respective forecastsforecasts for the relevant period provided always that such forecasts were proposed in good faith. The LICENSOR shall not give priority of supply to its requirements or its licensees requirements for the Product outside the Territory.
7.3.4 Intrexon 7.7.3. IMMEDICA shall make all purchases under this Section 7.3 7.7 by submitting firm purchase orders to Halozymethe LICENSOR. Each On a [*] basis, IMMEDICA shall submit such purchase order shall be in writing in a form reasonably acceptable to Halozymethe LICENSOR, and shall specify the quantity of API Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] days from after the date of such purchase order. No additional terms On a continual basis, IMMEDICA shall inform LICENSOR as soon as practical of any such purchase order shall be binding on Halozyme identified potential patient and are when a dosimetric dose of Product has been administered. Except as otherwise expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and provided in this Agreement, the terms and conditions LICENSOR shall be paid for its supply of the Product via the royalty paid by IMMEDICA under Section 6.1.3.
7.7.4. During the Term of this Agreement Agreement, to the extent that IMMEDICA orders a quantity of Product that is less than the quantity specified in the binding [*] of the Forecasts provided under Section 7.7.1, IMMEDICA shall prevailrefund LICENSOR’s wasted out-of pocket costs of buying iodine 131 and/or reserving non- cancellable manufacturing slots to manufacture Product that was not subsequently ordered, subject to the provision by LICENSOR of appropoirate evidence of such costs and to the extent that such iodine 131 or such manufacturing slots cannot be reused or cancelled by LICENSOR.
Appears in 1 contract
Sources: Exclusive License and Supply Agreement (Actinium Pharmaceuticals, Inc.)
Forecasts and Orders. 7.3.1 6.3.1 Not less than [*****] one hundred eighty (180) days prior to the first day of each calendar quarter (commencing with the first calendar quarter in which IntrexonB▇▇▇▇▇, its sublicensees or their respective Affiliates order API from Halozyme hereunder), Intrexon B▇▇▇▇▇ shall prepare and provide Halozyme with a written forecast of its good faith estimated requirements for API under this Section 7.3 6.3 for each of the subsequent [*****] six (6) calendar quarters. Intrexon B▇▇▇▇▇ shall not (a) increase or decrease the quantity estimated for the [*****] first quarterly period of each forecast from the quantity estimated for the [*****] second quarterly period of the previous forecast, or (b) increase or decrease the quantity estimated for the [*****] second and third quarterly periods of each forecast by more than [*****] twenty five percent ([*****]25%) of the quantity estimated for the [*****] third and fourth quarterly periods of the previous forecast, respectively, without the prior express written consent of Halozyme. The quantities estimated for the [*****] fifth and sixth quarterly periods of each forecast shall be non-binding, and for planning purposes only.
7.3.2 Intrexon 6.3.2 B▇▇▇▇▇ shall be required to purchase [*****] one hundred percent (100%) of the quantity forecasted for each API under this Section 7.3 6.3 for the first and second quarterly periods of each forecast under Section 7.3.16.3.1.
7.3.3 6.3.3 Halozyme shall be required to supply the quantity of API ordered by Intrexon B▇▇▇▇▇ under this Section 7.3 6.3 in any calendar quarter up to [*****] one hundred ten percent ([*****]110%) of the quantity forecasted for the [*****] first quarterly period of the most recent forecast. If Intrexon’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. B▇▇▇▇▇’▇ orders in any calendar quarter exceed [*****] one hundred ten percent ([*****]110%) of the quantity forecasted for the [*****] first quarterly period of the most recent forecast, Halozyme shall use commercially reasonable good faith efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet Intrexon’s B▇▇▇▇▇’▇ delivery requirements specified in accordance with Section 7.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon and its other customers on a pro rata basis according to their respective forecasts6.3.4.
7.3.4 Intrexon 6.3.4 B▇▇▇▇▇ shall make all purchases under this Section 7.3 6.3 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] sixty (60) days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement shall prevail.
Appears in 1 contract
Sources: Enhanze™ License and Collaboration Agreement (Halozyme Therapeutics Inc)
Forecasts and Orders. 7.3.1 Not less than [7.1 On or before **** of each year (except as otherwise mutually agreed), Alpharma shall submit to Purepac in writing Alpharma's non-binding estimate of its desired quantity of production of morphine coated pellets for use in the Products for the next Calendar Year (the "Annual Forecast Quantity").
7.2 Upon the Effective Date and thereafter at least **** prior to the beginning of each calendar quarter, Alpharma shall submit to Purepac in writing:
7.2.1 Alpharma's firm and binding forecast, specifying the quantity (by individual SKU) of Product Alpharma wishes to be available for delivery during the upcoming quarter, together with any instructions for special packaging (the "Quarterly Delivery Forecast") Alpharma's firm and binding Quarterly Delivery Forecast for the upcoming quarter shall represent the minimum quantity that Alpharma agrees to purchase during that quarter. At least **** prior to the beginning of a calendar quarter, Alpharma may, at its option, increase its Quarterly Delivery Forecast for said quarter by placing a written purchase order for an increased amount; provided however that, while Purepac shall use its reasonable efforts to fulfill any such increased order it shall not be obligated to supply an increased order to the extent it exceeds an additional **** percent (*****] days prior to %) of the first day of each calendar quarter (commencing with the first calendar quarter in which Intrexon, its sublicensees or their respective Affiliates order API from Halozyme hereunder), Intrexon shall prepare and provide Halozyme with a written forecast of its good faith estimated requirements for API under this Section 7.3 original Quarterly Delivery Forecast.
7.2.2 Forecasts for each of the subsequent [**** calendar quarters immediately following the quarter for which a purchase order must be submitted (by SKU) concurrent with the delivery of said Quarterly Delivery Forecast. It is understood that such forecasts constitute an estimate of the future requirements of Alpharma and do not comprise a binding commitment of Alpharma. Alpharma shall use its reasonable commercial endeavors to provide Purepac with accurate forecasts.
7.2.3 All Products shall be purchased by way of submission of purchase orders by Alpharma. Alpharma shall submit a binding purchase order for Products conforming with the Quarterly Delivery Forecast, and setting forth requested delivery dates (which shall not require that any more than **** percent (****%) of the Quarterly Delivery Forecast, adjusted as permitted herein, be delivered in any single month) at least *] *** prior to the commencement of said calendar quartersquarter. Intrexon A purchase order will represent a firm commitment by Alpharma to purchase the Products included thereon. Purepac shall not (a) increase or decrease the quantity estimated for the [accept any purchase order which is *****] quarterly period of each forecast from the quantity estimated for the [-percent (*****] quarterly period %) or less of the previous forecast, (b) increase or decrease the quantity estimated for the [Alpharma's Quarterly Delivery Forecast. Within *****] quarterly periods * of each forecast receipt of a purchase order, Purepac shall advise Alpharma whether it is able to fulfill the order and the date of shipment; provided that it shall have no right to object to the quantity or delivery dates requested by more than [Alpharma to the extent such request is within the scope permitted by this Section 7.2. In case Purepac has not replied within the stated time limit, Purepac shall be deemed to have accepted the order as placed.
7.3 Purepac shall advise Alpharma promptly of any event or circumstance that may make Purepac unable to deliver the Product as contemplated by this Agreement. A failure by Alpharma to purchase the Product provided for in any purchase order which Purepac is unable to deliver shall not constitute a breach by Alpharma of any term of this Agreement.
7.4 Purchase orders shall be placed at least *****] percent ([*****]%) * in advance of the quantity estimated for the [*****] quarterly periods of the previous forecast, respectively, without the prior express written consent of Halozyme. The quantities estimated for the [*****] quarterly periods of each forecast shall be non-binding, and for planning purposes onlyrequested delivery date.
7.3.2 Intrexon shall be required to purchase [*****] of the quantity forecasted for each API under this Section 7.3 for the first and second quarterly periods of each forecast under Section 7.3.1.
7.3.3 Halozyme shall be required to supply the quantity of API ordered by Intrexon under this Section 7.3 in any calendar quarter up to [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast. If Intrexon’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter exceed [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast, Halozyme shall use commercially reasonable efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet Intrexon’s delivery requirements specified in accordance with Section 7.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon and its other customers on a pro rata basis according to their respective forecasts.
7.3.4 Intrexon shall make all purchases under this Section 7.3 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the 7.5 The terms and conditions of this Agreement shall prevailprevail if the terms and conditions stated in Alpharma's purchase order or in Purepac's purchase order confirmations or in any other communication of the Parties relating to any purchase order are inconsistent with these terms and conditions.
7.6 If a shipment from Purepac is delayed more than **** for any reason and the delay causes any shortage of supply to Alpharma's customers, then, without prejudice to Alpharma's other rights and remedies with respect to such failure under this Agreement, and/or at law or in equity, Purepac shall air freight, at its own cost, Product directly to any and all such customers.
7.7 If either Party determines that any of the various time frame requirements found within Sections 7.1 through 7.6 herein materially affect their abilities to perform their respective obligations pursuant to this Agreement, the Parties agree to enter into good faith negotiations with the intent to alter such timing requirements in the best interests of the Parties.
Appears in 1 contract
Forecasts and Orders. 7.3.1 7.7.1. Not less than [*****] days prior to the first day of each calendar quarter Calendar Quarter (commencing with the first calendar quarter Calendar Quarter in which Intrexon, its sublicensees or their respective Affiliates order API IMMEDICA orders Unlabeled Product from Halozyme the LICENSOR hereunder), Intrexon IMMEDICA shall prepare and provide Halozyme the LICENSOR with a written forecast of its good faith estimated requirements for API under this Section 7.3 Unlabeled Product for each of the subsequent [*****] calendar quarters(each a “Forecast”). Intrexon IMMEDICA shall not (a) increase or decrease the quantity estimated for the [*****] quarterly period of each forecast from the quantity estimated for the [*****] quarterly period of the previous forecast, (b) increase or decrease the quantity estimated for the [*****] quarterly periods of each forecast by more than [*****] percent ([*****]%) of the quantity estimated for the [*****] quarterly periods of the previous forecast, respectively, without the prior express written consent of Halozyme. The quantities estimated for the [*****] all subsequent quarterly periods of each forecast Forecast shall be non-binding, and for planning purposes only. [*] IMMEDICA shall, in good faith, seek to limit its orders such that in any calendar year, it submits its entire year’s demand across [*] purchase orders.
7.3.2 Intrexon 7.7.2. IMMEDICA shall be required to purchase purchase, and the LICENSOR shall be required to supply, [*****] of the quantity forecasted for each API under this Section 7.3 for of Unlabeled Product forecast in the first and second quarterly periods [*] of each forecast under Section 7.3.1Forecast.
7.3.3 Halozyme 7.7.3. The LICENSOR shall be required to supply the quantity of API Unlabeled Product ordered by Intrexon IMMEDICA under this Section 7.3 7.7 in any calendar quarter Calendar Quarter up to [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecastForecast. If IntrexonIMMEDICA’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter exceed [*****] percent ([*****]%) of Calendar Quarter exceeds the quantity forecasted for the [*****] quarterly period of the most recent forecastForecast, Halozyme the LICENSOR shall use commercially reasonable efforts Commercially Reasonable Efforts to supply such excess. Halozyme The LICENSOR shall use commercially reasonable efforts Commercially Reasonable Efforts to meet IntrexonIMMEDICA’s delivery requirements specified in accordance with Section 7.3.47.7.4. In the event of a shortfall to forecastshortfall, Halozyme the LICENSOR shall promptly inform IMMEDICA and use commercially reasonable efforts Commercially Reasonable Efforts to apportion API Unlabeled Product among Intrexon IMMEDICA, the LICENSOR, and its other customers on a pro rata basis [*] according to their respective forecastsforecasts for the relevant period, provided always that such forecasts were proposed in good faith.
7.3.4 Intrexon 7.7.4. IMMEDICA shall make all purchases under this Section 7.3 7.7 by submitting firm purchase orders to Halozymethe LICENSOR. Each such purchase order shall be in writing in a form reasonably acceptable to Halozymethe LICENSOR, and shall specify the quantity of API Unlabeled Product ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] days after the date of such purchase order. In addition, IMMEDICA will specify the extent to which any Unlabeled Product should be supplied at a [*], in order to extend the shelf-life of the Product to [*] (the “[*]”). In the event that any [*] is ordered, it shall be prioritized by the LICENSOR such that the first order the LICENSOR delivers after a new manufacturing run has been completed shall be the [*] ordered by IMMEDICA. Upon receipt of a purchase order reflecting the requirements of this Section 7.7.4 by the LICENSOR, such purchase order shall be binding on both Parties. Notwithstanding the foregoing, if IMMEDICA places an order for delivery of Unlabeled Product and the requested delivery date is [*] after the last manufacturing run has been completed by the LICENSOR, then the LICENSOR may notify IMMEDICA in writing that such Unlabeled Product may not be able to comply with the minimum shelf-life requirements set out in Section 7.9.1, and what the remaining shelf-life of such Unlabeled Product would be (“Short-Dated Product”). In such circumstances, if IMMEDICA chooses to proceed with such order, it shall not be a breach of Section 7.9.1 if the Unlabeled Product delivered by LICENSOR to IMMEDICA does not have the minimum shelf-life requirements, provided it has the remaining shelf-life advised by the LICENSOR at the time that IMMEIDCA chooses to proceed with the order. If IMMEDICA chooses not to proceed with such order, then such purchase order shall automatically be cancelled and shall not be binding on the Parties. No additional terms of any such purchase order shall be binding on Halozyme the LICENSOR and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement shall prevail. IMMEDICA shall, in good faith, coordinate with LICENSOR to minimize placing orders with a requested delivery date after the first [*] of the manufacturing run.
Appears in 1 contract
Sources: License and Supply Agreement (Aeglea BioTherapeutics, Inc.)
Forecasts and Orders. 7.3.1 6.3.1 Not less than [*****] one hundred eighty (180) days prior to the first day of each calendar quarter (commencing with the first calendar quarter in which IntrexonRoche, its sublicensees or their respective Affiliates order API PH20 Bulk from Halozyme hereunder), Intrexon Roche shall prepare and provide Halozyme with a written forecast of its good faith estimated requirements for API PH20 Bulk under this Section 7.3 6 for each of the subsequent [*****] six (6) calendar quarters. Intrexon Roche shall not (a) increase or decrease the quantity estimated for the [*****] first quarterly period of each forecast from the quantity estimated for the [*****] second quarterly period of the previous forecast, (b) increase or decrease the quantity estimated for the [*****] second and third quarterly periods of each forecast by more than [*** percent (*****] percent ([*****]%) of the quantity estimated for the [*****] third and fourth quarterly periods of the previous forecast, respectively, without the prior express written consent of Halozyme. The quantities estimated for the [*****] fifth and sixth quarterly periods of each forecast shall be non-binding, and for planning purposes only.
7.3.2 Intrexon 6.3.2 Roche shall be required to purchase [*****] one hundred percent (100%) of the quantity forecasted for each API PH20 Bulk under this Section 7.3 6 for the first and second quarterly periods of each forecast under Section 7.3.16.3.1.
7.3.3 6.3.3 Halozyme shall be required to supply the quantity of API PH20 Bulk ordered by Intrexon Roche under this Section 7.3 6 in any calendar quarter up to [*** percent (*****] percent ([*****]%) of the quantity forecasted for the [*****] first quarterly period of the most recent forecast. If IntrexonRoche’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter exceed [*** percent (*****] percent ([*****]%) of the quantity forecasted for the [*****] first quarterly period of the most recent forecast, Halozyme shall use commercially reasonable good faith efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet IntrexonRoche’s delivery requirements specified in accordance with Section 7.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon and its other customers on a pro rata basis according to their respective forecasts6.3.4.
7.3.4 Intrexon 6.3.4 Roche shall make all purchases under this Section 7.3 6 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API PH20 Bulk ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] sixty (60) days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement shall prevail.
Appears in 1 contract
Sources: License and Collaboration Agreement (Halozyme Therapeutics Inc)
Forecasts and Orders. 7.3.1 Not less than [*****] days prior 2.1 LD shall provide M▇▇▇ with a twelve (12) month forecast estimating the number of Products, according to LD's market projections, that LD anticipates it shall purchase from M▇▇▇ during the upcoming twelve (12) month period. LD shall thereafter update the rolling forecast on a monthly basis for the then-upcoming twelve-month period ("Current Rolling Forecast"). M▇▇▇ shall use the Current Rolling Forecast to procure materials and plan manufacturing capacity. LD shall purchase 100% of the Product requirements, and M▇▇▇ agrees to use all reasonable efforts to ship I 00% of the Product requirements, indicated in the first day two (2) months of each calendar quarter any then Current Rolling Forecast. For the second two (commencing with the first calendar quarter in which Intrexon2) months of any then Current Rolling Forecast, its sublicensees or their respective Affiliates order API from Halozyme hereunder)LD shall commit to purchase a minimum of 70%, Intrexon and M▇▇▇ shall prepare and provide Halozyme with commit to use all reasonable efforts to supply up to a written forecast of its good faith estimated requirements for API under this Section 7.3 for each maximum 130%, of the subsequent [*****] calendar quartersforecasted amount of Product. Intrexon For the third two (2) months of any then Current Rolling Forecast, LD shall not (a) increase or decrease the quantity estimated for the [*****] quarterly period commit to purchase a minimum of each forecast from the quantity estimated for the [*****] quarterly period 50%, and M▇▇▇ shall commit to use all reasonable efforts to supply up to a maximum 150%, of the previous forecast, (b) increase or decrease the quantity estimated for the [*****] quarterly periods forecasted amount of each forecast by more than [*****] percent ([*****]%) of the quantity estimated for the [*****] quarterly periods of the previous forecast, respectively, without the prior express written consent of HalozymeProduct. The quantities estimated for the [*****] quarterly periods final six (6) months of each forecast any then Current Rolling Forecast shall be non-binding, and for planning purposes only. Purchase Orders spelling out specific quantities, delivery dates and destinations shall be issued in accordance with this Agreement, and shall be incorporated into, and be a material part of this Agreement All delivery schedules are by mutual agreement and subject to the capacity of available Tooling. M▇▇▇ will notify LD of the Tooling capacity limitations. Long lead time components will be covered by a separate authorization-to-buy from LD.
7.3.2 Intrexon 2.2 The terms of this Agreement shall be required to govern orders for Products. Except as specifically provided in Section 2.1 above, pre-printed or other terms and conditions contained in LD's purchase [*****] of the quantity forecasted for each API under this Section 7.3 for the first and second quarterly periods of each forecast under Section 7.3.1orders shall not apply unless agreed by M▇▇▇ in writing.
7.3.3 Halozyme shall be required 2.3 M▇▇▇ agrees to supply the quantity of API ordered by Intrexon under this Section 7.3 in any calendar quarter up to [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast. If Intrexon’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter exceed [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast, Halozyme shall use all commercially reasonable efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet Intrexon’s delivery requirements specified in accordance with Section 7.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon and its other customers on a pro rata basis according to their respective forecasts.
7.3.4 Intrexon shall make fill all purchases Purchase Orders for Products placed by LD under this Section 7.3 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, if within the terms Current Rolling Forecast and conditions of this Agreement shall prevail.purchase order lead time as agreed upon by the parties, and to notify LD within five
Appears in 1 contract
Sources: Manufacturing Agreement (Turnpoint Medical Devices, Inc.)
Forecasts and Orders. 7.3.1 Not less than [*****] days prior 2.1 LD shall provide ▇▇▇▇ with a twelve (12) month forecast estimating the number of Products, according to LD's market projections, that LD anticipates it shall purchase from ▇▇▇▇ during the upcoming twelve (12) month period. LD shall thereafter update the rolling forecast on a monthly basis for the then-upcoming twelve-month period ("Current Rolling Forecast"). ▇▇▇▇ shall use the Current Rolling Forecast to procure materials and plan manufacturing capacity. LD shall purchase 100% of the Product requirements, and ▇▇▇▇ agrees to use all reasonable efforts to ship I 00% of the Product requirements, indicated in the first day two (2) months of each calendar quarter any then Current Rolling Forecast. For the second two (commencing with the first calendar quarter in which Intrexon2) months of any then Current Rolling Forecast, its sublicensees or their respective Affiliates order API from Halozyme hereunder)LD shall commit to purchase a minimum of 70%, Intrexon and ▇▇▇▇ shall prepare and provide Halozyme with commit to use all reasonable efforts to supply up to a written forecast of its good faith estimated requirements for API under this Section 7.3 for each maximum 130%, of the subsequent [*****] calendar quartersforecasted amount of Product. Intrexon For the third two (2) months of any then Current Rolling Forecast, LD shall not (a) increase or decrease the quantity estimated for the [*****] quarterly period commit to purchase a minimum of each forecast from the quantity estimated for the [*****] quarterly period 50%, and ▇▇▇▇ shall commit to use all reasonable efforts to supply up to a maximum 150%, of the previous forecast, (b) increase or decrease the quantity estimated for the [*****] quarterly periods forecasted amount of each forecast by more than [*****] percent ([*****]%) of the quantity estimated for the [*****] quarterly periods of the previous forecast, respectively, without the prior express written consent of HalozymeProduct. The quantities estimated for the [*****] quarterly periods final six (6) months of each forecast any then Current Rolling Forecast shall be non-binding, and for planning purposes only. Purchase Orders spelling out specific quantities, delivery dates and destinations shall be issued in accordance with this Agreement, and shall be incorporated into, and be a material part of this Agreement All delivery schedules are by mutual agreement and subject to the capacity of available Tooling. ▇▇▇▇ will notify LD of the Tooling capacity limitations. Long lead time components will be covered by a separate authorization-to-buy from LD.
7.3.2 Intrexon 2.2 The terms of this Agreement shall be required to govern orders for Products. Except as specifically provided in Section 2.1 above, pre-printed or other terms and conditions contained in LD's purchase [*****] of the quantity forecasted for each API under this Section 7.3 for the first and second quarterly periods of each forecast under Section 7.3.1orders shall not apply unless agreed by ▇▇▇▇ in writing.
7.3.3 Halozyme shall be required 2.3 ▇▇▇▇ agrees to supply the quantity of API ordered by Intrexon under this Section 7.3 in any calendar quarter up to [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast. If Intrexon’s Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. orders in any calendar quarter exceed [*****] percent ([*****]%) of the quantity forecasted for the [*****] quarterly period of the most recent forecast, Halozyme shall use all commercially reasonable efforts to supply such excess. Halozyme shall use commercially reasonable efforts to meet Intrexon’s delivery requirements specified in accordance with Section 7.3.4. In the event of a shortfall to forecast, Halozyme shall use commercially reasonable efforts to apportion API among Intrexon and its other customers on a pro rata basis according to their respective forecasts.
7.3.4 Intrexon shall make fill all purchases Purchase Orders for Products placed by LD under this Section 7.3 by submitting firm purchase orders to Halozyme. Each such purchase order shall be in writing in a form reasonably acceptable to Halozyme, and shall specify the quantity of API ordered, the place of delivery and the required delivery date therefor, which shall not be less than [*****] days after the date of such purchase order. No additional terms of any such purchase order shall be binding on Halozyme and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, if within the terms Current Rolling Forecast and conditions of this Agreement shall prevail.purchase order lead time as agreed upon by the parties, and to notify LD within five
Appears in 1 contract
Sources: Manufacturing Agreement