Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c) or in the Manufacturing Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***] (ii) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date, which agreement will be consistent with and supersede the terms of this Section 2.4(c) and will otherwise be subject in all respects to the terms and conditions of this License Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (iii) The cost to Celgene of Vector Supply will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing. (iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix H, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***] (v) At Celgene’s request, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv), to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply. (vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.1, if and as applicable. (vii) For the purpose of this License Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.
Appears in 3 contracts
Samples: Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c7.4(b)(iv) or in the Manufacturing Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***]
(ii) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License CCPS Agreement Effective Date, which agreement will be consistent with and supersede the terms of this Section 2.4(c7.4(b) and will otherwise be subject in all respects to the terms and conditions of this License CCPS Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply for Commercialization for ROW Administration will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing. The cost of Vector Supply for Commercialization for U.S. Administration will be included in the Cost of Goods Sold. The cost of Vector Supply for Development will be included in the U.S. Development Costs, subject to adjustment as provided therein.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HI, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***]
(v) At Celgene’s request, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv7.4(b), to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.110.1, if and as applicable.
(vii) For the purpose of this License CCPS Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.
Appears in 3 contracts
Samples: Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c) or in the Manufacturing and Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***]
(ii) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date, which agreement will be consistent with and supersede the terms of this Section 2.4(c) and will otherwise be subject in all respects to the terms and conditions of this License Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HI, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***] Any such arbitration will be conducted under the then-current rules of the American Arbitration Association. Each Party will prepare and submit a written summary of such Party’s position with respect to the disputes issues and any relevant evidence in support thereof to the arbitrator within [***] days of selection of the arbitrator. Upon receipt of such summaries from both Parties, the arbitrator(s) will provide copies of the same to the other Party. The arbitrator will be authorized to solicit briefing or other submissions on particular questions. Within [***] days of the delivery of such summaries by the arbitrator, each Party will submit a written rebuttal of the other Party’s summary and may also amend and re-submit its original summary. Oral presentations will not be permitted unless otherwise requested by the arbitrator. The arbitrator will make a final decision with respect to the disputed issues within [***] days following receipt of the last of such rebuttal statements submitted by the Parties and [***]. Immediately following such arbitration decision, the Parties will enter into the Manufacturing and Supply Agreement which includes the terms and conditions agreed to by the Parties and such other terms and conditions decided by such arbitrator with respect to the disputed issues.
(v) At Celgene’s request, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv), to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.1, if and as applicable.
(vii) For the purpose of this License Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.I.
Appears in 2 contracts
Samples: License Agreement (2seventy Bio, Inc.), License Agreement (Bluebird Bio, Inc.)
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c7.4(b)(iv) or in the Manufacturing and Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***]
(ii) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License CCPS Agreement Effective Date, which agreement will be consistent with and supersede the terms of this Section 2.4(c7.4(b) and will otherwise be subject in all respects to the terms and conditions of this License CCPS Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply for Commercialization for ROW Administration will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing. The cost of Vector Supply for Commercialization for U.S. Administration will be included in the Cost of Goods Sold. The cost of Vector Supply for Development will be included in the U.S. Development Costs, subject to adjustment as provided therein.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HK, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***]
(v) At Celgene’s request, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv7.4(b), to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.110.1, if and as applicable.
(vii) For the purpose of this License CCPS Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.K.
Appears in 2 contracts
Samples: Master Collaboration Agreement (2seventy Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c) or in the Manufacturing and Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***]
(ii) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date, which agreement will be consistent with and supersede the terms of this Section 2.4(c) and will otherwise be subject in all respects to the terms and conditions of this License Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], ] unless otherwise agreed by the Parties in writing.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HI, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***]
(v) At Celgene’s request, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv), to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.1, if and as applicable.
(vii) For the purpose of this License Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.I.
Appears in 2 contracts
Samples: Master Collaboration Agreement (2seventy Bio, Inc.), Master Collaboration Agreement (Bluebird Bio, Inc.)
Vector Supply Terms. (iA) Except Bluebird shall use Commercially Reasonable Efforts to qualify its manufacturing facility for the Manufacture of Vector. Unless otherwise agreed by the Parties in writing, within [***] the Parties will negotiate in good faith a transfer plan to be agreed by the Parties, to engage in a technology transfer as provided otherwise set forth in this Section 2.4(c) or 2.4(b)(i)(E)(the “Suspension Transition Plan”). The Parties will use Commercially Reasonable Efforts to finalize the Suspension Transition Plan within [***]. The Parties shall commence the technology transfer activities referred to in such Suspension Transition Plan within [***]. From the date of U.S. approval of Bluebird’s facility for Vector and until completion of the Suspension Transition Plan and subject to the terms and conditions of the Manufacturing and Supply Agreement, Bluebird shall solely be responsible for the Manufacture of Vector and associated Payloads for U.S. Administration and ROW Administration. After completion of the Suspension Transition Plan, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all be primarily responsible for the Manufacture of Vector Supply and associated Payloads for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwidefor U.S. Administration, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect collaborate in good faith and use Commercially Reasonable Efforts to all such arrangements and obtain be Celgene’s prior written consentsecondary source of supply for the Manufacture of Vector and associated Payloads for Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field for ROW Administration in each case, which will not be unreasonably withheld, conditioned solely in connection with such “back-up” or delayed. [***]“business continuity source” rights under the Manufacturing and Supply Agreement.
(iiB) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third PartyAffiliate, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date, and associated Payloads within [***] which agreement will be consistent with and supersede the terms of this Section 2.4(c2.4(b)(i) and will otherwise be subject in all respects to the terms and conditions of this License Agreement (the “Manufacturing and Supply Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED).
(iiiC) The cost to Celgene of Vector Supply will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], ] unless otherwise agreed by the Parties in writing.
(ivD) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HI, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***].
(vE) At Celgene’s requestIn accordance with Appendix I, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expenseuse Commercially Reasonable Efforts, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv2.4(b)(i), to Manufacture Vector Supply (through the first commercial batch of Vector SupplyVector) itself or by through its designated Third Party manufacturermanufacturer (each a “Manufacturing Party”), by transferring all Know-How, Materials, technology How and trade secrets Materials Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector SupplyVector. Celgene shall bear [***] and Bluebird shall bear [***] of the Costs and expenses of the Parties associated with such technology transfer. Notwithstanding the foregoing, thereby enabling Celgene (Bluebird shall only be required to deliver Know-How and Materials in its or its Affiliates’ actual possession or under its control and shall not be required to produce or create any additional Know-How or Materials. Before any such Third Party) transfer, the Manufacturing Party shall enter into a reasonable confidentiality agreement with Bluebird with respect to Manufacture the Vector Supplyuse and handling of such Know-How and Materials.
(viF) Celgene will use Commercially Reasonable Efforts to establish a second source of Vector within [***].
(G) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.1, if and as applicable.
(viiH) For the purpose of this License Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.I.
(I) Celgene agrees to collaborate in good faith with Bluebird and use Commercially Reasonable Efforts to Manufacture Vector for U.S. Administration to the extent circumstances would require Bluebird to activate “business continuity source” supply for U.S. Administration. Bluebird agrees to collaborate in good faith with Celgene and use Commercially Reasonable Efforts to Manufacture Vector for ROW Administration to the extent circumstances would require Bluebird to activate “business continuity source” supply for ROW Administration pursuant to the Manufacturing and Supply Agreement.
(J) For as long as Bluebird is sole source of supply of Vector, in the event of any supply deficiency or shortage of Vector or associated Payload, any available Vector or Payload supplies shall be allocated for U.S Administration and ROW Administration on pro rata basis, using the forecasted demand for the year in which such deficiency or shortage occurs, unless otherwise agreed by the Parties in writing.
Appears in 2 contracts
Samples: License Agreement (2seventy Bio, Inc.), License Agreement (Bluebird Bio, Inc.)
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c7.4(b)(iv) or in the Manufacturing and Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***].
(ii) Reference is hereby made to that certain Vector Manufacturing and Clinical Supply Agreement, executed by the Parties as of July 10, 2017 (the “Clinical Vector Supply Agreement”), for Vector Supply in support of certain activities for the Development of the Elected Candidate and Licensed Product on an interim basis during the period prior to the execution of a Manufacturing and Supply Agreement. The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date[***], which agreement will be consistent with and supersede the terms of this Section 2.4(c7.4(b) and the Clinical Vector Supply Agreement, and will otherwise be subject in all respects to the terms and conditions of this License CCPS Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply for Commercialization for ROW Administration will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing. The cost of Vector Supply for Commercialization for U.S. Administration will be included in the Cost of Goods Sold (for clarity, as a component of the Manufacturing Costs). The cost of Vector Supply for Development will be included in the U.S. Development Costs, subject to adjustment as provided therein.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HJ, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***].
(v) At Celgene’s requestIn accordance with Section 7.4(b)(iv), Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv), Celgene to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.110.1, if and as applicable.
(vii) For the purpose of this License CCPS Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.J.
Appears in 2 contracts
Samples: Co Development, Co Promote and Profit Share Agreement (2seventy Bio, Inc.), Co Development, Co Promote and Profit Share Agreement (Bluebird Bio, Inc.)
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c7.4(b)(iv) or in the Manufacturing and Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***].
(ii) Reference is hereby made to that certain Vector Manufacturing and Clinical Supply Agreement, executed by the Parties as of July 10, 2017 (the “Clinical Vector Supply Agreement”), for Vector Supply in support of certain activities for the Development of the Elected Candidate and Licensed Product on an interim basis during the period prior to the execution of a Manufacturing and Supply Agreement. The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date[***], which agreement will be consistent with and supersede the terms of this Section 2.4(c7.4(b) and the Clinical Vector Supply Agreement, and will otherwise be subject in all respects to the terms and conditions of this License CCPS Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply for Commercialization for ROW Administration will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing. The cost of Vector Supply for Commercialization for U.S. Administration will be included in the Cost of Goods Sold (for clarity, as a component of the Manufacturing Costs). The cost of Vector Supply for Development will be included in the U.S. Development Costs, subject to adjustment as provided therein.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HJ, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***].
(v) At Celgene’s requestIn accordance with Section 7.4(b)(iv), Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv), Celgene to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary CONFIDENTIAL TREATMENT REQUESTED BY BLUEBIRD BIO, INC. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.110.1, if and as applicable.
(vii) For the purpose of this License CCPS Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.J.
Appears in 1 contract
Samples: Co Development, Co Promote and Profit Share Agreement
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c) or in the Manufacturing and Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***]
(ii) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date, which agreement will be consistent with and supersede the terms of this Section 2.4(c) and will otherwise be subject in all respects to the terms and conditions of this License Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HI, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***]
(v) At Celgene’s request, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv), to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.1, if and as applicable.
(vii) For the purpose of this License Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.I.
Appears in 1 contract
Vector Supply Terms. (i) Except as provided otherwise in this Section 2.4(c) or in the Manufacturing and Supply Agreement, Bluebird and its Affiliates will Manufacture, or cause a Third Party to Manufacture, all Vector Supply for all Elected Candidate and Licensed Product required for clinical Development and Commercialization in the Field worldwide, and will have the right to make all necessary decisions regarding arrangements with Third Party manufacturers, provided that Bluebird will reasonably consult with Celgene with respect to all such arrangements and obtain Celgene’s prior written consent, which will not be unreasonably withheld, conditioned or delayed. [***].
(ii) The Parties will enter into a “Manufacturing and Supply Agreement,” between each other or among the Parties and an Affiliate or a Third Party, covering Vector Supply as soon as reasonably practicable after the License Agreement Effective Date, which agreement will be consistent with and supersede the terms of this Section 2.4(c) and will otherwise be subject in all respects to the terms and conditions of this License Agreement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
(iii) The cost to Celgene of Vector Supply will equal [***] of Bluebird’s Fully Burdened Manufacturing Cost for such Manufacture, plus [***], unless otherwise agreed by the Parties in writing.
(iv) The Manufacturing and Supply Agreement will include the terms set forth in Appendix HI, including terms permitting Celgene to establish “back-up” and/or “second source” rights for Vector Supply and license grants from Celgene to Bluebird under the Celgene Licensed Product IP and Celgene Licensed Product In-Licensed IP to the extent necessary or useful for Bluebird to Manufacture Vector Supply. [***]. Any such arbitration will be conducted under the then-current rules of the American Arbitration Association. Each Party will prepare and submit a written summary of such Party’s position with respect to the disputes issues and any relevant evidence in support thereof to the arbitrator within [***] days of selection of the arbitrator. Upon receipt of such summaries from both Parties, the arbitrator(s) will provide copies of the same to the other Party. The arbitrator will be authorized to solicit briefing or other submissions on particular questions. Within [***] days of the delivery of such summaries by the arbitrator, each Party will submit a written rebuttal of the other Party’s summary and may also amend and re-submit its original summary. Oral presentations will not be permitted unless otherwise requested by the arbitrator. The arbitrator will make a final decision with respect to the disputed issues within [***] days following receipt of the last of such rebuttal statements submitted by the Parties [***]. Immediately following such arbitration decision, the Parties will enter into the Manufacturing and Supply Agreement which includes the terms and conditions agreed to by the Parties and such other terms and conditions decided by such arbitrator with respect to the disputed issues.
(v) At Celgene’s request, Bluebird will cooperate with Celgene’s reasonable requests, at Celgene’s cost and expense, to engage in a technology transfer to allow Celgene, in accordance with Section 2.4(c)(iv), to Manufacture Vector Supply (through the first commercial batch of Vector Supply) itself or by through its designated Third Party manufacturer, by transferring all Know-How, Materials, technology and trade secrets Controlled by Bluebird or its Affiliates that are necessary to Manufacture Vector Supply, thereby enabling Celgene (or such Third Party) to Manufacture the Vector Supply.
(vi) Any purchase of Vector Supply from Bluebird or its designee will expressly not include any license rights to any Know-How or Patents, but instead all licenses (implied, by exhaustion or otherwise) will arise under Section 3.1, if and as applicable.
(vii) For the purpose of this License Agreement, certain words and phrases (and their correlatives) relating to Manufacturing will have the meanings set forth on Appendix D.I.
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