Supply of Product. Except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products, upon exercise of the Option to License with respect to a given Program, and upon Servier’s request, Cellectis shall Manufacture or have Manufactured in compliance with cGMP the corresponding Products for Servier’s benefit until the end of the Phase II studies to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions shall be negotiated in good faith between the Parties within a period [***] upon exercise of each Option to License. The supply price of the Product (in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at any time before entering into the first Phase II studies but after the exercise of the corresponding Option to License for any Product, to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transfer), and will start at Cellectis’ discretion within [***] following: (i) election by Servier to have the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, to Servier or its Designee; (ii) sending by Servier to Cellectis of a written waiver of Servier’s rights under Section 5.2 paragraph 1 to request Cellectis to manufacture or have manufactured such Product, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase II, such waiver will nonetheless be effective only once the technology transfer will be successfully and timely completed.
Appears in 2 contracts
Samples: License, Development and Commercialization Agreement (Cellectis S.A.), License, Development and Commercialization Agreement (Cellectis S.A.)
Supply of Product. Except for UCART19 [6.1 As provided herein, PENWEST shall purchase in whole lot quantities, and MYLAN will supply PENWEST with, sufficient quantities of Product to meet all of the requirements therefor of each Authorized Distributor during the term of this Agreement; provided, however, that MYLAN will supply, in less than whole lot quantities, up to a ***]*************** as reasonably requested for use in the testing and certification of the Product and its manufacture. MYLAN and PENWEST will share equally the costs of such testing and certification quantities by adjustments to the amounts payable from Other Compensation. To the extent permitted under applicable law, PENWEST shall cause the Authorized Distributor(s) to agree that they shall purchase all of their requirements for the Product from PENWEST during such period, subject to such commercially reasonable contingent agreements (the "Contingent License") as PENWEST may make to permit one or more Authorized Distributors to manufacture the Product on its own (or to obtain it from an alternate source) in the event that MYLAN is not able, or for any reason fails, for any continuous period in excess of *********, or has been so unable, or has so failed, for any cumulative period of ***************************, to supply PENWEST hereunder Product sufficient in quantity and quality to meet such Authorized Distributor's requirements therefor, including without limitation the Consignment Inventory described in Section 6.8.
6.2 MYLAN shall purchase and PENWEST shall supply TIMERx for use in the manufacture of the Product pursuant to this Agreement at the price, and any other UCART19 Productson the terms, UCART19 Subsequent Products and UCART19 Substitute Products, upon exercise set forth in the Nifedipine XL Agreement. Following the FDA U.S. approval of the Option Designated Product for sale under the Nifedipine XL Agreement, quantities to License be purchased hereunder shall be added to the estimates and orders called for under the Nifedipine XL Agreement. If PENWEST notifies MYLAN of an Authorized Distributor's estimates for Product to be ordered hereunder (whether before or after FDA approval of the Designated Product for sale in the Mylan Territory under the Nifedipine XL Agreement), MYLAN shall time its orders for TIMERx accordingly, as if (for such scheduling purposes) the Authorized Distributor's requested shipment dates were the dates for MYLAN's sales of the Designated Product under the Nifedipine XL Agreement. Payment for the TIMERx shall be made as provided in the Nifedipine XL Agreement.
6.3 All sales of Product shall be F.O.B., Morgantown, West Virginia, or Caguas, Puerto Rico, as MYLAN may specify (but no change from one location to the other shall be made on less than 45 days' prior written notice), and PENWEST or the Authorized Distributor (as they may agree) shall bear all transportation, insurance, taxes, duties, and other costs and risks of loss, spoilage and damage associated with the shipping and delivery of Product to PENWEST or the Authorized Distributor.
6.4 MYLAN shall be responsible to obtain and maintain any and all regulatory approvals and licenses for the manufacture of the Product by it in West Virginia and/or in Puerto Rico and for export from those locations to the Territory. MYLAN warrants that it will not change or modify the formulation, manufacturing methods, Bulk Packaging specifications, and/or Product Specifications as provided hereunder, without at least thirty days' prior written notice to PENWEST. If MYLAN is required by the FDA to change the formulation, manufacturing methods, or Product Specifications for the product it is then making for sale in the MYLAN Territory, or MYLAN otherwise institutes such changes on its own due to its good faith determination that the same are necessary or beneficial for the production of the product for sale in the MYLAN Territory, and if such changes would require the consent of any regulatory agency in the Territory with regard to the approval or continuing right to use the same in connection with the Product for sale in the relevant country, MYLAN will have the following options, with respect to a given Programthe relevant country(ies) in the Territory:
6.4.1 MYLAN may continue to manufacture the Product under the prior formulation, manufacturing methods and Product Specifications, for supply under this Agreement, and upon Servier’s requestSection 1.6.2 will be applicable;
6.4.2 where such changes may reasonably be acceptable to the relevant regulatory agency(ies), Cellectis MYLAN may assist PENWEST and the Authorized Distributor to secure the approval from the relevant health CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. regulatory agency(ies) in the Territory for its making the same changes with respect to the Product to be supplied under this Agreement, including without limitation MYLAN's sharing equally with PENWEST the costs of all reasonable efforts to secure such approval(s);
6.4.3 MYLAN may permit this circumstance to be a triggering event that brings into effect the Contingent License, without the contingency of the passage of the 30 days specified in Section 6.1. MYLAN must pursue at least one of these options with respect to each applicable country in the Territory at all times, in such a circumstance. MYLAN may pursue more than one of these options simultaneously as follows: If MYLAN pursues the option in 6.4.1, it may, but it need not, also pursue the option in 6.4.2 (and, in either case, the option in 6.4.3 would not be then applicable). If MYLAN pursues the option in 6.4.3, it may, but it need not, also pursue the option in 6.4.2 (but, in either case, the option in 6.4.1 would not be then applicable). MYLAN must pursue either 6.4.1 or 6.4.3 in conjunction with 6.4.2, if it elects to pursue 6.4.2 at all.
6.5 At least ********* before an Authorized Distributor begins sale of the Product, PENWEST shall Manufacture deliver to MYLAN a written, non-binding estimate of all the Authorized Distributor's requirements of Product for the ********* ********* period following the anticipated first commercial sale by the Authorized Distributor. PENWEST will deliver to MYLAN updates to such estimates on or have Manufactured in compliance with cGMP before the corresponding Products first day of each ********* thereafter during the term of this Agreement, which updates may revise estimates previously submitted and will add estimates for Servier’s benefit until additional months so that at all times such estimate shall cover the ****************** ********* period following the end of the Phase II studies to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions shall be negotiated in good faith between the Parties within a period [***] upon exercise of each Option ****** in which the estimate is made. MYLAN shall not be obligated to License. The supply price the Authorized Distributor with quantities of the Product (in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [during any ***]****** in excess of ****************** of the quantities estimated in the Authorized Distributor's highest written estimate applicable to that *********.
6.6 PENWEST shall deliver to MYLAN a firm written order stating the Authorized Distributor's requirements for Product no less than ********* in advance of the requested delivery date therefor. Servier To the extent practicable, PENWEST will group into single orders all such requirements for each Authorized Distributor CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. for the entire Territory for each ********* covered by each such order.
6.7 No order for the Product hereunder may elect be cancelled or deferred by PENWEST except by written notice delivered to MYLAN at least ********* prior to the scheduled delivery date. No orders may be cancelled or deferred (even with such ********* notice) without MYLAN's approval if such cancellation or deferral would reduce PENWEST's or the Authorized Distributor's purchases for the ********* *************************** of the highest quantities of the Product estimated as to such *********.
6.8 MYLAN will supply to PENWEST, to be consigned with the applicable Authorized Distributor, an inventory of approximately ********* production of the Product for such Authorized Distributor, based on PENWEST's projections given under Section 6.5 for the ********* extending beyond the ********* firm ordering period. This shall be referred to as the "Consignment Inventory." The initial Consignment Inventory will be drawn down and replenished on a regular, first-in-first-out basis as the Authorized Distributor takes deliveries therefrom for its sales. The parties agree that each of them will *************************** of the MYLAN Cost of Product for the Consignment Inventory at any time before entering into given time.
6.9 Subject to and conditional upon the first Phase II studies but after failure of MYLAN to meet the exercise PENWEST Authorized Distributor's requirements for Product as described in Section 6.1, upon the request of PENWEST, MYLAN grants to PENWEST, as part of the corresponding Option Contingent License, a license under the MYLAN Manufacturing Technology to License have made by the Authorized Distributor Product for any sale in the Territory during the term of the Authorized Distributor Agreement. Said license shall exist only for those periods, if any, in which MYLAN is unable to supply the Product, plus an additional period of up to ********* after MYLAN's notice that it is again able and ready to supply the Product, during which the Authorized Distributor will be entitled to exhaust work-in-process and any inventory of finished goods. Neither PENWEST nor the Authorized Distributor shall have the manufacture right to grant a sublicense hereunder (other than by PENWEST to the Authorized Distributor) without the prior written consent of MYLAN, which consent shall not be unreasonably withheld. In order to facilitate the communication of the MYLAN Manufacturing Technology to the Authorized Distributor and the certification of its facility as contemplated herein, such Products transferred that there will be no significant delay in doing so if PENWEST's rights under this Section 6.9 ever become applicable, MYLAN will exert reasonable efforts to disclose the MYLAN Manufacturing Technology to the Authorized Distributor(s) designated for such purpose by Cellectis or its designeePENWEST, including without limitation by making knowledgeable MYLAN personnel reasonably available, at Servier’s a consulting fee not in excess of MYLAN's CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. actual costs, to Servierconsult with the Authorized Distributor or with representatives of PENWEST who may then consult in turn with the Authorized Distributor, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) all to the Contract Manufacturing Organization extent necessary to enable the know-howAuthorized Distributor to produce Product that would otherwise have been supplied by MYLAN. MYLAN will make such disclosure and provide such consultation within a reasonable time following the signing of this Agreement, material and data necessary in any event prior to the filing by the Authorized Distributor of the first Product License Application for the proper manufacturing Product to be filed by such Authorized Distributor in the Territory, it being understood, however, that such early consultation shall not give the Authorized Distributor any right to make any production use of the ProductsMYLAN Manufacturing Technology unless and until the license under this Section becomes applicable, other than in connection with obtaining the advance regulatory certification in the Territory of the Authorized Distributor's own facility as an approved alternate site of manufacture of the Product. For sake This Section and the license described will survive the termination of claritythis Agreement due to any breach by MYLAN, except for UCART19 [the balance of the Term otherwise provided for in Section 3.1.
6.10 In the event that, and for so long as, MYLAN is unable due to causes beyond its control to supply product to PENWEST and the Authorized Distributor, and Section 6.9 is instituted, or if Section 6.9 is instituted as described in 6.4.3, PENWEST shall, in lieu of the price and payments described in Section 5, pay to MYLAN in consideration of the grant of such license to the MYLAN Manufacturing Technology an amount equal to ***], ****** of the Sales Royalties received from the Authorized Distributor making the Product using the MYLAN Manufacturing Technology as permitted under Section 6.9.
6.11 If and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that the failure of MYLAN described in such case Section 6.9 is due to causes beyond MYLAN's control, and if MYLAN establishes to PENWEST's reasonable satisfaction that MYLAN is diligently attempting through its best efforts to remove or resolve such causes such that MYLAN will be able, or will again be able, to supply the manufacturing of such subsequent ProductProduct as contemplated herein (which, Subsequent Products in the circumstances described in Section 6.4, will require, at a minimum, that 6.4.2 be applicable and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transferthat MYLAN actively and continuously pursue the option described in 6.4.2), and will start at Cellectis’ discretion within [PENWEST shall, in addition to the sums payable under Section 6.10, pay to MYLAN a further sum equal to ***] following******:
(i) election by Servier to have the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, to Servier or its Designee;
(ii) sending by Servier to Cellectis of a written waiver of Servier’s rights 6.11.1 14- CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. ****************************************** ********** as permitted under Section 5.2 paragraph 1 6.9 for the supply by PENWEST of TIMERx to request Cellectis be used in such manufacturing, *************** ************************** ****** therefor; *******
6.11.2 for by such Authorized Distributor during such period as to manufacture which MYLAN so establishes that it is diligently making such attempts to remove or have manufactured resolve such causes of MYLAN's disability to supply the Product, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase II, such waiver will nonetheless be effective only once the technology transfer will be successfully and timely completed.
Appears in 2 contracts
Samples: Sales and Distribution Agreement (Penwest Pharmaceuticals Co), Sales and Distribution Agreement (Penwest Pharmaceuticals Co)
Supply of Product. Except 5.01. Until the earlier of (i) December 31, 2000 or (ii) earlier termination of this Agreement, SBCL shall supply EXIGENT with clinical samples to be reasonably agreed to by the parties to enable EXIGENT to validate tests for UCART19 its POCT research and development of PRODUCT. SBCL shall supply such samples to EXIGENT and EXIGENT shall reimburse SBCL for SBCL's internal costs, if any, for retrieving such samples. EXIGENT shall bear all costs of transporting such samples from SBCL's facilities to EXIGENT's facilities and all associated liabilities for transport of such samples. EXIGENT also shall bear all cost and liability associated with such validation studies. (EXIGENT does not hereby assume liability properly assessed against any third party.)
5.02. Within 90 days after FDA APPROVAL, or when otherwise agreed upon by the parties, SBCL and EXIGENT shall agree upon terms (including price per each unit of PRODUCT) for supply of PRODUCTS by EXIGENT to SBCL. EXIGENT shall supply SBCL with all of its requirements of PRODUCT as reasonably requested by SBCL and shall ship such PRODUCTS from EXIGENT's facility to the facility specified by SBCL. EXIGENT shall have the fight and obligation to supply SBCL with all of SBCL's requirements for PRODUCT (including packaging). SBCL shall pay EXIGENT an amount equal to EXIGENT's production costs plus XXX [***]Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] for the instruments and the,, cartridges and any reagents comprising the PRODUCTS. For purposes of this Section 5.02, EXIGENT's production costs will be all direct and indirect manufacturing costs, overheads, packaging and labeling related to the manufacture of POCT PRODUCTS. Costs not related to the manufacture of POCT PRODUCTS, including without limitation research and development, administration, sales and marketing, distribution and other UCART19 Productsmiscellaneous non-manufacturing costs, UCART19 Subsequent Products shall not be included in production costs. Warranty costs shall be included in production costs but shall not be subject to the XXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and UCART19 Substitute ProductsExchange Commission.] markup. Upon FDA APPROVAL, upon exercise SBCL shall purchase a minimum of XXXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Option Securities and Exchange Commission.] instruments during the first three month period commencing with FDA APPROVAL, XXXXXXXXXXXXX [Omitted pursuant to License a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] instruments during the second three month period and thereafter XXXXXXXXXXXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] instruments during each subsequent three month period for the TERM OF THIS AGREEMENT. Upon FDA APPROVAL during the five one-year periods following such FDA APPROVAL, SBCL shall purchase minimum quantities of cartridges as follows: Year 1 XXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] cartridges Year 2 XXXXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] cartridges Year 3 XXXXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] cartridges Year 4 XXXXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] cartridges Year 5 XXXXXXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with the Securities and Exchange Commission.] cartridges SBCL shall have the right to audit EXIGENT's books and records with respect to documentation of EXIGENT's costs.
5.03. SBCL shall submit rolling forecasts with six month projections for the PRODUCT to EXIGENT on a given Program, quarterly country by country basis. SBCL shall place firm purchase orders with EXIGENT that are consistent with the current three month projection in such forecasts and upon Servier’s request, Cellectis shall Manufacture or have Manufactured that contain a delivery date that reflects quantities of instruments and cartridges that are consistent with the amounts projected in compliance the current forecast.
5.04. XXXXX [Omitted pursuant to a request for confidential treatment. The material has been filed separately with cGMP the corresponding Products for Servier’s benefit until Securities and Exchange Commission.]
5.05. To the end extent of the Phase II studies to be conducted by Servierquantities specified in SBCL's rolling forecast, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions SBCL shall be negotiated in good faith between the Parties within a period [***] upon exercise of each Option to License. The supply price of the Product (in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at any time before entering into the first Phase II studies but after the exercise of the corresponding Option to License for any Product, to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee priority with respect to such technology transferEXIGENT's manufacturing output vis a vis other customers.
5.06. Payment for PRODUCT shipped shall be net 45 days FOB EXIGENT's shipping point.
5.07. In the event that EXIGENT develops a successor diagnostic instrument or system and determines to cease production of an earlier model (including the cartridges, reagents and other consumable supplies for the earlier model), and will start at Cellectis’ discretion within [***] following:
(i) election by Servier EXIGENT agrees that it shall continue to have supply the manufacture earlier model for 12 months from the date of approval of the Products transferred by Cellectis successor PRODUCT in each country in the TERRITORY and to supply the cartridges, reagents and other consumable supplies for the earlier model for 24 months from such date or its designee, at Servier’s costs, in either case for such longer period of time as EXIGENT makes such PRODUCTS available to Servier or its Designee;
(ii) sending by Servier to Cellectis of a written waiver of Servier’s rights under Section 5.2 paragraph 1 to request Cellectis to manufacture or have manufactured such Product, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase II, such waiver will nonetheless be effective only once the technology transfer will be successfully and timely completedother customers.
Appears in 2 contracts
Samples: Distribution and Supply Agreement (Careside Inc), Distribution and Supply Agreement (Careside Inc)
Supply of Product. Except for UCART19 [***]2.1 As of the Effective Date the Supplier shall make reasonably available to Buyer, and any other UCART19 Products, UCART19 Subsequent the Proposed Products and UCART19 Substitute Productsthe Specifications therefore, upon exercise which Proposed Product the Buyer shall purchase at the price set in Section 5, for purposes of evaluation. Following Buyer's evaluation, the Buyer shall then either accept the Specification provided by the Supplier or propose an alternative specification. Once the parties have agreed in writing as to the --------------- * [CONFIDENTIAL TREATMENT REQUESTED] INDICATES MATERIAL WHICH HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Specification that shall apply to the Proposed Product, then the Specification shall become the Specification for the Product and such Product shall be added as appropriate to Schedule C or Schedule D and be subject to the following terms and conditions. In the event that the parties are not able to agree on the specification for the Proposed Product, then Supplier shall replace such Proposed Product with an alternative Proposed Product.
2.2 During the term of this Agreement (including renewals) and subject to all of the Option terms and provisions of this Agreement, Supplier shall manufacture and sell bulk quantities of unpackaged Product to License Buyer. Product shall be quality control tested, manufactured, stored and shipped by Supplier in strict conformity with respect the Specifications. The Supplier shall provide specifications to a given Program, and upon Servier’s request, Cellectis shall Manufacture or have Manufactured in compliance with cGMP the corresponding Products Buyer for Servier’s benefit until the end each Product within thirty (30) days of the Phase II studies to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions Effective Date. Quality control testing shall be negotiated performed by Supplier in good faith between accordance with the Parties within a period [***] upon exercise of each Option to License. The supply price of Specifications and the Product (shall meet the Specifications as provided by the Supplier or as the Specifications may be modified by mutual agreement in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at writing prior to issuance of any time before entering into the first Phase II studies but after the exercise of the corresponding Option to License for any Product, to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, purchase order under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transfer), and will start at Cellectis’ discretion within [***] following:
(i) election by Servier to have the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, to Servier or its Designee;
(ii) sending by Servier to Cellectis of a written waiver of Servier’s rights under Section 5.2 paragraph 1 to request Cellectis to manufacture or have manufactured such Product, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase II, such waiver will nonetheless be effective only once the technology transfer will be successfully and timely completedParagraph 3.
Appears in 1 contract
Samples: Supply Agreement (Endogen Inc)
Supply of Product. Except for UCART19 [***]13.1 Licensor shall supply the Finished Product to Licensee in accordance with the terms of this Agreement, and all other terms (save for those agreed by the Parties) whether express or implied, shall be excluded from any other UCART19 Productscontract for Finished Product.
13.2 Licensor shall (subject to Clause 12.3), UCART19 Subsequent Products during the Term, manufacture and UCART19 Substitute Productsdeliver such quantities of Finished Product which are ordered by Licensee in writing from time to time within sixty (60) days from the date of Licensee's Binding Purchase Order pursuant to Clause 12.1. Subject to the foregoing, upon exercise Licensor shall confirm in writing each purchase order within five (5) business days from the receipt of the Option same.
13.3 As part of the Supply Price, Licensor shall package and label Finished Product manufactured by Licensor according to License with respect to a given ProgramClause 13.1 above for distribution by Licensee. As part of the Supply Price, Licensor shall package and upon Servier’s request, Cellectis shall Manufacture or have Manufactured label Products in compliance with cGMP the corresponding Products instructions provided by Licensee, provided that Licensor shall have no obligation to implement new packaging or labelling requirements communicated by Licensee with a lead time of less than two (2) months. If permitted by rules and regulations in the Territory, Licensor shall be identified as the developer/manufacturer/licensor of the Finished Product distributed in the Territory. The packaging of the Finished Product, approved by Licensee using supporting documentation provided by Licensee, shall be: (a) sufficient to protect the Finished Product during shipment, (b) compliant with environmental regulations or other relevant rules or regulations; and (c) contain the proper labelling as instructed by Licensee pursuant to this Agreement. Licensee may repackage any Finished Product units.
13.4 Licensor shall use reasonable endeavours to supply the Finished Product and to meet the delivery date. Without prejudice to any rights or remedies available to Licensee under law or this Agreement, Licensor agrees to promptly notify Licensee after becoming aware of any actual or anticipated delay in any delivery of Finished Product. In the event that Licensor could not fulfil the delivery of the Product within three (3) months after the lead time pursuant to Clause 12.1, then the Licensee shall be entitled to demand Licensor for Serviera compensation which is limited to ten percent (10%) of the value of the delayed Finished Product.
13.5 All Finished Product delivered by Licensor shall be delivered CIP Arlanda Sweden - Narita Japan (per Incoterms 2000, made part of this Agreement by reference) or to any other destination specified by Licensee from time to time within the Territory.
13.6 Licensee shall use its reasonable endeavours to collect the Finished Product in a prompt manner. Warehouse or storage costs incurred by Licensor due to Finished Product being left at the point of delivery for an extended period of time on Licensee’s benefit instructions, or as a result of an act or omission of Licensee, shall be borne by Licensee.
13.7 Risk in the Finished Product shall pass to Licensee upon delivery.
13.8 The title to any consignment of the Finished Product shall not pass to Licensee until Licensor has received payment in full of the price.
13.9 During such time as title in the Finished Product remains with Licensor, Licensee shall:
13.9.1 store or otherwise keep the Finished Product in such a way as clearly to indicate at all times that the Finished Product are owned by Licensor and shall not remove, obscure or delete any mxxx placed on the Finished Product by Licensor which may enable the Finished Product to be identified; and
13.9.2 have the power to deal with or use the Finished Product (and other goods in which the Finished Product are incorporated) as fiduciary bailee of Licensor in the normal course of its business and to dispose of the Finished Product or such goods by way of bona fide sale at full market value.
13.10 In order to secure the availability and timely delivery of the Finished Product to Licensee, Licensor agrees to undertake to keep at all times, at its sole costs, expense and responsibility, in its premises a sufficient safety stock of Finished Product (the “Safety Stock”) designated to Licensee. Such Safety Stock shall correspond to at least three (3) months of Licensee’s average monthly orders for Finished Product over the previous twelve (12) calendar months to be assessed and updated at the end of each calendar quarter, and shall be rotated with Licensor’s regular inventory of Finished Product to maintain shelf life. For the Phase II studies avoidance of doubt, the Parties expressly agree that the costs and expenses incurred by Licensor as result of keeping such Safety Stock shall be deemed already included in the Supply Price.
13.11 Licensor shall not deliver Finished Product which is not manufactured at an approved facility and shall not change the manufacturing site and/or the regulatory commitments (which are defined in the Marketing Authorisation documentation and shall include without limitation manufacturing method and specification) for the Finished Product without obtaining prior written approval therefore from Licensee and the Competent Authority.
13.12 During the Term and the time which Licensee uses its stock of Finished Product delivered by Licensor, Licensor shall provide Licensee, and at Licensee’s request also the Competent Authority, with letter(s) of authorisation as well as any documentation relating to be conducted the Finished Product required by ServierLicensee, or such authorities, for Marketing Authorisation.
13.13 Licensee's right to possession of the Finished Product shall terminate immediately upon the any of the events listed in Clause 24.2(b) affecting Licensee, or if Licensee encumbers any of the Finished Product.
13.14 Licensee grants Licensor, its Affiliates agents and employees an irrevocable right at any time to enter any premises where the Finished Product are or its Servier Sublicenseesmay be stored in order to inspect them, subject or, where Licensor's right to a written supply and quality agreements whose terms and conditions possession has terminated, to recover them.
13.15 During the Term Licensee or any Competent Authority shall be negotiated entitled upon prior written notice to visit, inspect and carry out audits relating to the Finished Product at Licensor's facilities, to verify the compliance with this Agreement. With regard to Licensor such visits shall be arranged during normal working hours within four (4) weeks from the date of notice. For purposes of such audits, the Parties undertake to co-operate in good faith between with each other and provide the Parties within a period [***] upon exercise of each Option other party with such information and documentation relating to License. The supply price of the Finished Product (in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at any time before entering into the first Phase II studies but after the exercise of the corresponding Option to License for any Product, to have and the manufacture of such Products transferred to by Cellectis or its designeethereof, at Servier’s costs, to Servier, its US Partner or its Designee which it may reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transfer), and will start at Cellectis’ discretion within [***] following:
(i) election by Servier to have the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, to Servier or its Designee;
(ii) sending by Servier to Cellectis of a written waiver of Servier’s rights under Section 5.2 paragraph 1 to request Cellectis to manufacture or have manufactured such Product, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase II, such waiver will nonetheless be effective only once the technology transfer will be successfully and timely completedrequest.
Appears in 1 contract
Samples: Development, Supply and Exclusive License Agreement (Oasmia Pharmaceutical AB)
Supply of Product. Except for UCART19 [***](a) Subject to the provisions of this Agreement, Sanofi Pasteur shall purchase exclusively from BPC, Sanofi Pasteur’s worldwide requirements of the Product.
(b) In accordance with the Annual Forecast requirements as set forth in Section 2.2 of the Agreement, and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products, upon exercise of the Option to License with respect to a given Program, and upon Servier’s request, Cellectis shall Manufacture or have Manufactured in compliance with cGMP the corresponding Products for Servier’s benefit until the end of the Phase II studies to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions Section 2.1 (c), BPC shall be negotiated in good faith between manufacture the Parties within a period Product from up to [***] upon exercise liters of each Option to LicenseSource Plasma annually (the “Full Volume Target”). The supply price BPC understands that after both Sanofi and BPC Transition Periods, BPC will be Sanofi Pasteur’s sole manufacturing source for manufacture of the Product Product.
(in finished formc) shall be at manufacturing costsAfter both Sanofi and BPC Transition Periods, incurred by Cellectis, plus BPC will agree to use [***]. Servier may elect at any time before entering into ] to manufacture the first Phase II studies but after the exercise of the corresponding Option to License for any Product, from up to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***]] liters of Source Plasma annually, and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made equally distributed based on availability of Source Plasma, through the course of the year. For purpose of clarity, in the event BPC temporarily shuts down its plant for any subsequent Productsmaintenance or upgrades after the BPC Transition Period, Subsequent Products BPC shall make all the necessary arrangements to reasonably accommodate Sanofi Pasteur’s volume needs in accordance with the Firm Purchase Commitment as described in Section 2.3. BPC will agree to use [***] for all manufacturing requested above [***] liters of Source Plasma annually based on BPC’s available capacity and Substitute Products directed against the same Target ability to accommodate such additional volumes.
(d) All Product supplied to Sanofi Pasteur shall be packaged and labeled as defined by Sanofi Pasteur and shall be shipped in accordance with Sanofi Pasteur’s purchase orders therefore. Except to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee parties may otherwise agree with respect to a particular shipment, the Product shall be ordered by Sanofi Pasteur pursuant to annual written Sanofi Pasteur purchase orders, which shall be sent to BPC on or before [***] of each year during the term of this Agreement. It is understood between the parties that such technology transfer)annual purchase order shall be fully consistent with the discussions the parties shall hold pursuant to Section 2.2. BPC shall supply the Product resulting from processing of approximately [***] liters per Batch, as specified in the annual purchase order, of Source Plasma supplied by Sanofi Pasteur and will start at Cellectis’ discretion shall deliver such Product to Sanofi Pasteur within [***] following:of the delivery dates specified in such purchase order. Confidential treatment has been requested with respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(e) During the BPC Transition Period and the Sanofi Transition Period, Sanofi Pasteur and BPC will mutually agree on the number of Batches of Product to be manufactured by BPC. The parties will meet to discuss in good faith and agree on the timely completion of such transfer. As part of the FDA and, AFSSAPS or EMA approval processes, BPC will manufacture [***] conformance batches as ordered by Sanofi Pasteur under the terms and conditions of this Agreement.
(f) After the BPC Transition Period and the Sanofi Transition Period, Sanofi Pasteur shall purchase a minimum of [***] Batches during a calendar year if and when (i) election Sanofi Pasteur is authorized by Servier the FDA, the AFSSAPS, PEI (Germany) and Health Canada to have market any product manufactured from the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, to Servier or its Designee;
Product; and (ii) sending by Servier to Cellectis the parties will have agreed in writing on the quality agreement and on the Quantity Range as defined in Section 3.1 below. The minimum purchase requirement of a written waiver [***] Batches is conditional on BPC supplying Source Plasma in sufficient quantities and at sufficient rabies antibody levels that such Batches would be useable for further production of ServierSanofi Pasteur’s rights under Section 5.2 paragraph 1 to request Cellectis to manufacture or have manufactured such Product, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase IIfinal rabies hyperimmune plasma product. However, such waiver will nonetheless be effective only once obligation to purchase a minimum of [***] Batches in a calendar year shall not apply to the technology transfer will be successfully Sanofi Transition Period and timely completedBPC Transition Period.
Appears in 1 contract
Supply of Product. Except (a) For the term of this Agreement, or for UCART19 as long as CIMA manufactures any of the Products hereunder, whichever is shorter, [***]CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] agrees to purchase from CIMA and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products, upon exercise of the Option CIMA agrees to License with respect to a given Program, and upon Servier’s request, Cellectis shall Manufacture or have Manufactured in compliance with cGMP the corresponding Products for Servier’s benefit until the end of the Phase II studies to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions shall be negotiated in good faith between the Parties within a period [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] upon exercise with all of each Option to License. The supply price of the Product (in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at any time before entering into the first Phase II studies but after the exercise of the corresponding Option to License for any ProductCONFIDENTIAL TREATMENT REQUESTED, to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] requirements for the proper manufacturing of the Products. For sake of clarity, except Product samples and Product placebos for UCART19 their subsequent use, sale, lease or transfer by [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis .
(or its designee, under Cellectis’ responsibilityb) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transfer), and will start at Cellectis’ discretion within [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] following:agrees to initiate purchases of the Products, Product samples and Product placebos hereunder by issuing CIMA binding purchase orders not less than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to the required shipping date set forth therein. CIMA agrees to accept any order issued in accordance with this Section 5.1(b) and to meet the delivery dates specified thereon. All purchase orders hereunder shall be on [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] standard purchase order form (a copy of which is attached as Schedule 5.1(b) 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 be unreasonably withheld or delayed) and shall be directed to CIMA at the address set forth below. The terms and conditions of purchase enumerated on the reverse side of such standard purchase order form shall prevail over any inconsistent or conflicting language as may exist on invoices, confirmation or order acknowledgment forms of CIMA, provided, however, that in the event any terms thereof are in conflict, or are inconsistent with any terms of this Agreement, the terms and conditions hereof shall prevail. No Product delivered by CIMA shall have a shelf life that is more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE EXHIBIT 10.25 COMMISSION.***] less than the maximum shelf life of such Product (other than batches that were under investigation and batches for validation which shall have not more than [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] less than the maximum shelf life of such Product upon delivery to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]).
(ic) election Purchase order quantities shall be in full batch sizes that are mutually agreed by Servier to have the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, to Servier or its Designee;parties.
(iid) sending by Servier [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall cause the amount of API that CIMA requires to Cellectis perform its obligations pursuant to Schedule 3.1 and Sections 5.1 and 5.5 to be provided at no charge to CIMA [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] prior to date of a written waiver tablet manufacture, as well as [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] of Servier’s rights under Section 5.2 paragraph 1 safety stock. API must conform to request Cellectis [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] then current raw materials specifications. CIMA shall not be accountable for production or shipment delays due to manufacture or have manufactured such Productlack of API.
(e) EXCEPT AS SPECIFICALLY PROVIDED HEREIN, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase IIINCLUDING, such waiver will nonetheless be effective only once the technology transfer will be successfully and timely completedWITHOUT LIMITATION, SECTION 7.8, THE PRODUCT WILL BE SUPPLIED BY CIMA WITH NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
Appears in 1 contract
Samples: Master Development, License and Supply Agreement (Cima Labs Inc)
Supply of Product. Except (a) For the consideration provided herein and in accordance with all terms, conditions, representations and warranties set forth herein, and for UCART19 the term hereof, Mallinckrodt will provide DAS with such amounts of Product as DAS shall request. DAS agrees that it shall purchase at least [***]***] of its requirements for Product from Mallinckrodt hereunder during every Contract Year during the term of this Agreement. For purposes of the preceding sentence "Contract Year" shall mean (i) for the first year of this Agreement, the period beginning on June 9, 2000 and ending on June 30, 2001, and any other UCART19 Products(ii) for each year thereafter during the term of this Agreement, UCART19 Subsequent Products the twelve (12) month period beginning on July 1 and UCART19 Substitute Products, upon exercise of the Option to License with respect to a given Program, and upon Servier’s request, Cellectis shall Manufacture or have Manufactured in compliance with cGMP the corresponding Products for Servier’s benefit until the end of the Phase II studies to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions ending on June 30. All Product supplied hereunder shall be negotiated manufactured by Mallinckrodt strictly in good faith between accordance with the Parties within a period Specifications (defined below) and current Good Manufacturing Practices ("cGMP") as determined by the United States Food and Drug Administration ("FDA") using the manufacturing process described in Mallinckrodt's Drug Master File. If and as applicable, Mallinckrodt shall comply with the cGMP of those countries outside the United States represented on Exhibit B.
(b) The specifications for Product (including, without limitation, specifications for all components and raw materials, whether active or inactive) are described on Exhibit A attached hereto ("Specifications").
(c) Notwithstanding anything to the contrary herein and if, for any Contract Year after the first Contract Year of this Agreement, Mallinckrodt is unable to supply DAS with such quantities of Product as DAS shall order hereunder, the minimum amount of Product that Mallinckrodt shall be obligated to supply to DAS in any given Contract Year thereafter, shall be that amount of Product ordered by DAS in any such subsequent Contract Year which represents the [******] upon exercise of each Option sold by Mallinckrodt to Licenseall unaffiliated parties and to other Mallinckrodt business [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. The supply price of CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION, CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. units in such subsequent Contract Year as the Product (in finished form) shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at any time before entering into ***] in the first Phase II studies but after the exercise of the corresponding Option to License for any Product, to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the immediately previous Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) Year bears to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing ***] of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing all forms of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transfer), and will start at Cellectis’ discretion within [******] following:
(i) election by Servier to have the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, all [******] and to Servier or its Designee;
(ii) sending by Servier to Cellectis of a written waiver of Servier’s rights under Section 5.2 paragraph 1 to request Cellectis to manufacture or have manufactured [******] business units in such Product, Subsequent Product and Substitute Product directed against the same Target (under conditions specified above) until the end of Phase II, such waiver will nonetheless be effective only once the technology transfer will be successfully and timely completedimmediately previous Contract Year.
Appears in 1 contract
Supply of Product. Except The details for UCART19 [***]manufacturing Product will be determined after the execution of this Agreement, according to the following conditions:
(a) Agouron shall be responsible for manufacturing Product.
(b) Agouron shall * , in accordance with a Product Supply Plan to be entered into between the Parties, * the amount of Product which can be manufactured from * of Compound, to be used in implementing the Development Program in the JE Territory; the Product Supply Plan, when agreed upon, will be incorporated as part of the Development Program. Agouron * JE * Product for use in implementing the Development Program * which equals * of procuring and/or producing such Product, * such * of * ; provided, however, that JE shall provide Agouron, * , all Compound necessary to manufacture such Product for JE (or * Agouron for the cost of the Compound, plus * such * used by Agouron to manufacture such Product for JE).
(c) In accordance with the provisions of Section 4.04, JE shall * from Agouron, and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products, upon exercise of the Option to License with respect to a given Program, and upon Servier’s request, Cellectis Agouron shall Manufacture or have Manufactured in compliance with cGMP the corresponding Products for Servier’s benefit until the end of the Phase II studies timely deliver Product to be conducted by Servier, its Affiliates or its Servier Sublicensees, subject to a written supply and quality agreements whose terms and conditions shall be negotiated sold in good faith between the Parties within a period [***] upon exercise of each Option to LicenseJE Territory. The supply price of the Product (in finished form) to be sold to JE by Agouron shall be at manufacturing costs, incurred by Cellectis, plus [***]. Servier may elect at any time before entering into the first Phase II studies but after the exercise of the corresponding Option to License for any Product, to have the manufacture of such Products transferred to by Cellectis or its designee, at Servier’s costs, to Servier, its US Partner or its Designee reasonably acceptable to Cellectis. The Parties will execute a tri-partite technology transfer agreement between Servier, the Contract Manufacturing Organization and Cellectis, provided that Cellectis will transfer (or will have transferred) to the Contract Manufacturing Organization the know-how, material and data necessary for the proper manufacturing of the Products. For sake of clarity, except for UCART19 [***], and any other UCART19 Products, UCART19 Subsequent Products and UCART19 Substitute Products Cellectis (or its designee, under Cellectis’ responsibility) shall use diligent efforts to perform the technology transfer to Servier, its US Partner or its Designee necessary for Servier to conduct the manufacturing of each Product. Such technology transfer will be made on a Product-by-Product basis (provided that once such technology transfer has been made for a Product, it is deemed to be made for any subsequent Products, Subsequent Products and Substitute Products directed against the same Target to the extent that in such case and if the manufacturing of such subsequent Product, Subsequent Products and Substitute Products requires additional technology transfer due to subsequent changes, Cellectis shall use its Commercially Reasonable Efforts to provide reasonable support to Servier, its US Partner or its Designee with respect to such technology transfer), and will start at Cellectis’ discretion within [***] following:
(i) election by Servier to have the manufacture of the Products transferred by Cellectis or its designee, at Servier’s costs, to Servier or its Designee;
(ii) sending by Servier to Cellectis of a written waiver of Servier’s rights under Section 5.2 paragraph 1 to request Cellectis to manufacture or have manufactured price which * such Product, Subsequent plus a * . "FBMCP" or "Fully Burdened Manufacturing Cost of Product" means the cost of Product shipped, and Substitute shall include the direct and indirect costs of procuring and/or producing such Product directed against shipped in accordance with either generally accepted accounting principles or the same Target equivalent international accounting standards. Direct costs shall include direct labor (under conditions specified aboveincluding fringe benefits), direct materials (including taxes and duties) until and third-party contract costs required to manufacture the end bulk product Compound (or related intermediates) and the finished Product. Indirect costs (to be allocated to the production effort) shall include, but not be limited to, items treated as "manufacturing overhead," such as indirect labor and materials, fringe benefits, occupancy costs (including electricity, water, waste disposal, other utilities and property taxes), depreciation of Phase IIproperty, such waiver will nonetheless plant and equipment used in the manufacturing process, and other costs allocable to the manufacturing process. Overhead shall not include start-up costs, or idle or excess capacity charges. Included in the cost of Product shall be effective only once the technology transfer will be successfully manufacturing variances, including inventory reserves and timely completednon-conforming production runs.
Appears in 1 contract
Samples: License and Supply Agreement (Agouron Pharmaceuticals Inc)