Technology Transfer. Promptly after the occurrence of any Triggering Event, Moderna will provide written notice thereof to AstraZeneca. After receipt of such notice, or after becoming aware of the occurrence of any Triggering Event, AstraZeneca will notify Moderna by written notice whether the rights and obligations under this Section 4.5 and Section 4.6 will apply to [***]; provided, that AstraZeneca may not elect to have the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) [***] and (iii) [***], in which case [***] will apply, unless and until another Triggering Event occurs (the Moderna mRNA API(s) that are the subject of the transfer [***], the “Transferred API(s)”). Within [***] days of a Triggering Event, Moderna will, and will cause its Affiliates and its manufacturers to, [***]. Without limiting the generality of the foregoing, with respect to each Transferred API [***] with respect to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expense: (a) make available to AstraZeneca [***] a copy of [***] (the “Manufacturing Know-How”); (b) cause appropriate employees and representatives of Moderna and its Affiliates and [***] to [***]; (c) take such steps as are [***]; (d) upon AstraZeneca’s request, [***]; (e) upon AstraZeneca’s request, [***]; and (f) provide such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] in accordance with the applicable Specifications, including [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth above, [***] in connection with such technology transfer, and AstraZeneca will be [***] in connection with such technology transfer. AstraZeneca and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) for so long as it elects (subject to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following the completion of the technology transfer for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading to the Triggering Event were rectified.
Appears in 2 contracts
Sources: Services and Collaboration Agreement (Moderna, Inc.), Services and Collaboration Agreement (Moderna, Inc.)
Technology Transfer. Promptly after the occurrence of any Triggering Event31.1 If:
(A) Clause 31.2 applies; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, Moderna will provide written notice thereof to AstraZeneca. After receipt of such notice, or after becoming aware of the occurrence of any Triggering Event, AstraZeneca will notify Moderna by written notice whether the rights and obligations under this Section 4.5 and Section 4.6 will apply to [***]; provided, that AstraZeneca may not elect to have the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) [***] and (iii) MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
(B) Clause 31.3 applies; or
(C) Clause 32.3 applies where Purchaser is the Terminating Party; or
(D) Clause 32.5 applies; or
(E) Clause 32.6(B) applies; or
(F) Clause 37.2(ii) applies; GSK shall, subject to Clause 31.5, facilitate a one-time technology transfer to the Purchaser (or Purchaser’s designee) (the “Technology Transfer”). The Parties shall use Commercially Reasonable Efforts to create a technology transfer plan relating to the Technology Transfer (the “Technology Transfer Plan”). The Technology Transfer Plan shall relate solely to the production process employed by GSK in which case the Manufacture of the Products and (unless initiated pursuant to Clause 31.2) shall be developed based on the expected date of expiry or termination of this Agreement and the availability of GSK Personnel and resources to support such transfer. Purchaser and GSK shall cooperate to ensure that supporting such Technology Transfer pursuant to the Technology Transfer Plan does not place an undue burden on GSK personnel and other resources. GSK shall transfer (subject to the terms of the licences granted in the Purchase Agreement) applicable records, documentation, GSK Know-How and GSK Intellectual Property in accordance with the Technology Transfer Plan and the timelines, formats, and other guidelines set forth therein. Except for a Technology Transfer pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F), the Purchaser shall reimburse GSK for such Technology Transfer support services [***]. The Purchaser will reimburse GSK for such services pursuant to Clause 13 (Invoice and Payment). If there is (i) an ongoing Technology Transfer at the time of expiration or termination of the Agreement or (ii) this Agreement is terminated by the Purchaser pursuant to Clause 32.3(A) or Clause 37.2, the Technology Transfer Plan will survive for [***] from such termination or expiration date. For clarity, the Purchaser shall not be required to reimburse GSK for any Technology Transfer support services, or direct costs or expenses associated with such Technology Transfer, if such Technology Transfer has been initiated by the Purchaser pursuant to Clause 31.1(C), 31.1(D), 31.1(E) or 31.1(F).
31.2 Subject to Clause 4.1 and without prejudice to Clause 2.3, the Purchaser may utilize one or more Third Parties to act as second source(s) of manufacture for Products (each, a “Second Source”). The Purchaser may elect to implement a Technology Transfer to a Second Source pursuant to Clause 31.1(A) at any time by notice in writing to GSK.
31.3 The Purchaser may elect to implement a Technology Transfer pursuant to Clause 31.1(B) in the event of:
(A) a material or repeated failure on the part of GSK to meet, or notification by GSK that it will applybe unable to meet, unless and until another Triggering Event occurs (the Moderna mRNA API(s) that are the subject of the transfer any Firm Order for Commercial Product or Commercial API; or CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. (B) a material or repeated failure on the “Transferred API(spart of GSK to Manufacture Commercial Product or Commercial API in accordance with cGMP or the applicable Specifications, provided that (in each case) such failure is not due to any act or omission of Purchaser.
31.4 Following a Technology Transfer undertaken pursuant to Clause 31.1(B) or Clause 31.1(C) (but not a Technology Transfer undertaken pursuant to Clause 31.1(A) or Clause 31.1(D)”). Within [***] days , Purchaser shall be relieved of a Triggering Eventits obligations under Clause 4.1 to purchase certain requirements for Products from GSK, Moderna willas set out therein.
31.5 For the avoidance of doubt, GSK shall not be required to support more than one Technology Transfer in respect of Commercial API and will cause its Affiliates and its manufacturers toone Technology Transfer in respect of Commercial Products, [***]. Without limiting the generality of the foregoing, with respect to each Transferred API [***] with respect to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expensesuch that:
(aA) make available to AstraZeneca [***] the recipient Third Party and/or manufacturing site of a copy Technology Transfer in respect of [***] (Commercial API may be a different from the “Manufacturing Know-How”)recipient Third Party and/or manufacturing site of a Technology Transfer in respect of Commercial Products;
(bB) cause appropriate employees and representatives if any Technology Transfer has been initiated in respect of Moderna and its Affiliates and [***] Commercial API pursuant to [***];
a provision of Clause 31.1, no additional Technology Transfer in respect of Commercial API may subsequently be initiated or required pursuant to the same or any other provision of Clause 31.1 (c) take such steps as are [***];
(d) upon AstraZenecabut this is without prejudice to the Purchaser’s request, [***];
(e) upon AstraZeneca’s request, [***]rights to implement a Technology Transfer in respect of Commercial Products pursuant to any provision of Clause 31.1); and
(fC) provide if any such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] Technology Transfer has been initiated in accordance with the applicable Specifications, including [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth above, [***] in connection with such technology transfer, and AstraZeneca will be [***] in connection with such technology transfer. AstraZeneca and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca respect of Commercial Products pursuant to this Section 4.5 a provision of Clause 31.1, no additional Technology Transfer in support respect of Manufacturing the Transferred API(s) for so long as it elects (subject Commercial Products may subsequently be initiated or required pursuant to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for same or any other reason or for any other product or product candidate provision of Clause 31.1 (or intermediate or component thereof). [***] Following the completion of the technology transfer for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading but this is without prejudice to the Triggering Event were rectifiedPurchaser’s rights to implement a Technology Transfer in respect of Commercial API pursuant to any provision of Clause 31.1).
Appears in 2 contracts
Sources: Commercial Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Commercial Manufacturing and Supply Agreement (Dermavant Sciences LTD)
Technology Transfer. Promptly after the occurrence of any Triggering Event, Moderna will provide written notice thereof to AstraZeneca. After receipt of such notice, or after becoming aware of the occurrence of any Triggering Event, AstraZeneca will notify Moderna by written notice whether the rights and obligations under this Section 4.5 and Section 4.6 will apply to [***]; provided, that AstraZeneca may not elect to have the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) [***] and (iii) [***], in which case [***] will apply, unless and until another Triggering Event occurs (the Moderna mRNA API(s) that are the subject of the transfer [***], the “Transferred API(s)”). Within [***] days of a Triggering Event, Moderna will, and will cause its Affiliates and its manufacturers to, [***]. Without limiting the generality of the foregoing, with respect to each Transferred API [***] with respect to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expense:
(a) make available to AstraZeneca [***] a copy of [***] (the “Manufacturing Know-How”);
(b) cause appropriate employees and representatives of Moderna and its Affiliates and [***] to [***];
(c) take such steps as are [***];
(d) upon AstraZeneca’s request, [***];
(e) upon AstraZeneca’s request, [***]; and
(f) provide such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] in accordance with the applicable Specifications, including [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth above, [***] in connection with such technology transfer, and AstraZeneca will be [***] in connection with such technology transfer. AstraZeneca and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) for so long as it elects (subject to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following the completion of the technology transfer for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading to the Triggering Event were rectified.
Appears in 1 contract
Sources: Services and Collaboration Agreement
Technology Transfer. Promptly after Upon (i) termination by either Party or during the occurrence notice period regarding termination of this Agreement or a Project, (ii) at any Triggering Eventtime at ELAN’s sole discretion during the pendency of this Agreement or a Project or (iii) on approaching expiry of this Agreement, Moderna will provide written notice thereof to AstraZeneca. After receipt of such notice, or after becoming aware of the occurrence of any Triggering Event, AstraZeneca will notify Moderna ELAN may by written notice whether to BI Pharma seek assistance from BI Pharma with respect to the rights and obligations under this Section 4.5 and Section 4.6 will apply transfer to [***]; provided, that AstraZeneca may not elect to have another manufacturer (“CMO”) of the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) [***] and any associated Technology solely for the purpose of manufacturing Product (iii) [***]“Technology Transfer”). Following BI Pharma’s receipt of such notice, the Parties will establish, in which case good faith, a schedule and plan to enable a knowledgeable manufacturer to continue manufacture of Product consistent with then current industry standards for effecting such transfer and BI Pharma will thereafter co-operate with ELAN in implementing such plan. However, it is understood by ELAN that BI Pharma cannot guarantee that such Technology Transfer will lead to the successful implementation of the process at ELAN or its named CMO.
11.5.3.1 As part of the Technology Transfer, BI Pharma will (i) transfer to the manufacturer or ELAN, as ELAN directs, all Technology, know-how and information necessary for performing the Process by a party skilled in the art of biotechnology processing (ii) make available for collection, subject to any regulatory obligations, all [***] will applygenerated pursuant to the this Agreement and the Projects up to the date of termination or expiry, unless i.e. batch records, development reports and until another Triggering Event occurs production process documentation, and (the Moderna mRNA API(siii) that are the subject transfer, or if transfer cannot reasonably be performed, make available, to ELAN and its Affiliates and licensees and any applicable regulatory agencies, all other documentation reasonably necessary for clinical testing and commercialization of the transfer [***], Product.
11.5.3.2 The obligations on BI Pharma in respect of the “Transferred API(s)”). Within Technology Transfer shall be exercisable by ELAN within a period beginning [***] days prior to the date of a Triggering Event, Moderna will, termination or expiry (whichever is the earlier) and will cause its Affiliates and its manufacturers to, [***]. Without limiting the generality of the foregoing, with respect to each Transferred API ending [***] with respect after the date of termination or expiry (whichever is the earlier).
11.5.3.3 The foregoing Technology Transfer shall be limited capacitywise to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expense:
(a) make available to AstraZeneca [***] full time equivalents (FTE) for [***] working days, which may be used in the period set forth above. Thereafter, ELAN shall pay [***] and all other costs shall be charged as agreed.
11.5.3.4 ELAN shall enter into a copy written sublicense and confidentiality agreement with the CMO containing terms [***] and shall be responsible for any for any breach of the provisions of this Agreement by the CMO. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
11.5.3.5 ELAN shall pay to BI Pharma a fee for the Technology Transfer in an amount of [***] Euro (the “Manufacturing Know-How”);
(bEuro [***]) cause appropriate employees and representatives if a total of Moderna and its Affiliates and less than [***] to [***];
runs of clinical supply (c“Clinical Campaign”) take such steps as are [***];
(d) upon AstraZeneca’s requesthas taken place, [***];
(e) upon AstraZeneca’s request, [***]; and
(f) provide such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] in accordance with the applicable Specifications, including [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth above, [***] in connection with such technology transfer, and AstraZeneca will which fee shall be [***] in connection with such technology transfer. AstraZeneca that has taken place and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) been paid for so long as it elects (subject to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following the completion of the technology transfer by ELAN for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading to the Triggering Event were rectifiedspecific Project.
Appears in 1 contract
Sources: Master Process Development and Clinical Supply Agreement
Technology Transfer. Promptly after Upon (i) termination by either Party or during the occurrence notice period regarding termination of this Agreement or a Project, (ii) at any Triggering Eventtime at ELAN’s sole discretion during the pendency of this Agreement or a Project or (iii) on approaching expiry of this Agreement, Moderna will provide written notice thereof to AstraZeneca. After receipt of such notice, or after becoming aware of the occurrence of any Triggering Event, AstraZeneca will notify Moderna ELAN may by written notice whether to BI Pharma seek assistance from BI Pharma with respect to the rights and obligations under this Section 4.5 and Section 4.6 will apply transfer to [***]; provided, that AstraZeneca may not elect to have another manufacturer (“CMO”) of the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) [***] and any associated Technology solely for the purpose of manufacturing Product (iii) [***]“Technology Transfer”). Following BI Pharma’s receipt of such notice, the Parties will establish, in which case good faith, a schedule and plan to enable a knowledgeable manufacturer to continue manufacture of Product consistent with then current industry standards for effecting such transfer and BI Pharma will thereafter co-operate with ELAN in implementing such plan. However, it is understood by ELAN that BI Pharma cannot guarantee that such Technology Transfer will lead to the successful implementation of the process at ELAN or its named CMO.
11.5.3.1 As part of the Technology Transfer, BI Pharma will (i) transfer to the manufacturer or ELAN, as ELAN directs, all Technology, know-how and information necessary for performing the Process by a party skilled in the art of biotechnology processing (ii) make available for collection, subject to any regulatory obligations, all [***] will applygenerated pursuant to the this Agreement and the Projects up to the date of termination or expiry, unless i.e. batch records, development reports and until another Triggering Event occurs production process documentation, and (the Moderna mRNA API(siii) that are the subject transfer, or if transfer cannot reasonably be performed, make available, to ELAN and its Affiliates and licensees and any applicable regulatory agencies, all other documentation reasonably necessary for clinical testing and commercialization of the transfer [***], Product.
11.5.3.2 The obligations on BI Pharma in respect of the “Transferred API(s)”). Within Technology Transfer shall be exercisable by ELAN within a period beginning [***] days prior to the date of a Triggering Event, Moderna will, termination or expiry (whichever is the earlier) and will cause its Affiliates and its manufacturers to, [***]. Without limiting the generality of the foregoing, with respect to each Transferred API ending [***] with respect after the date of termination or expiry (whichever is the earlier).
11.5.3.3 The foregoing Technology Transfer shall be limited capacitywise to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expense:
(a) make available to AstraZeneca [***] full time equivalents (FTE) for [***] working days, which may be used in the period set forth above. Thereafter, ELAN shall pay [***] and all other costs shall be charged as agreed.
11.5.3.4 ELAN shall enter into a copy written sublicense and confidentiality agreement with the CMO containing terms [***] and shall be responsible for any for any breach of the provisions of this Agreement by the CMO.
11.5.3.5 ELAN shall pay to BI Pharma a fee for the Technology Transfer in an amount of [***] Euro (the “Manufacturing Know-How”);
(bEuro [***]) cause appropriate employees and representatives if a total of Moderna and its Affiliates and less than [***] to [***];
runs of clinical supply (c“Clinical Campaign”) take such steps as are [***];
(d) upon AstraZeneca’s requesthas taken place, [***];
(e) upon AstraZeneca’s request, [***]; and
(f) provide such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] in accordance with the applicable Specifications, including [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth above, [***] in connection with such technology transfer, and AstraZeneca will which fee shall be [***] in connection with such technology transfer. AstraZeneca that has taken place and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) been paid for so long as it elects (subject to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following the completion of the technology transfer by ELAN for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading to the Triggering Event were rectifiedspecific Project.
Appears in 1 contract
Sources: Master Process Development and Clinical Supply Agreement (Prothena Corp PLC)
Technology Transfer. Promptly after 15.1 In the occurrence event that (i) OSI determines that the Manufacturer is unable to reasonably meet its obligations to supply Product or Starting Materials, as the case may by, under this Agreement and such failure leads to a breach of any Triggering EventOSI’s obligations under the OSI/GNE Agreement and (ii) an Assumption Notice (as defined in Section 16.6 thereof) is delivered to the Manufacturer, Moderna will provide written notice thereof Genentech, as a third-party beneficiary of this Agreement, shall have the right to AstraZeneca. After receipt of such notice, procure some or after becoming aware all of the occurrence Product or Starting Materials that were to be manufactured by the Manufacturer pursuant to this Agreement from a third party manufacturer. In order to facilitate such transfer of any Triggering Event, AstraZeneca will notify Moderna by written notice whether the rights and obligations under this Section 4.5 and Section 4.6 will apply to [***]; provided, that AstraZeneca may not elect to have Genentech the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) [***] and (iii) [***], in which case [***] will apply, unless and until another Triggering Event occurs (the Moderna mRNA API(s) that are the subject of the transfer [***], the “Transferred API(s)”). Within [***] days of a Triggering Event, Moderna will, and will cause its Affiliates and its manufacturers to, [***]. Without limiting the generality of the foregoing, with respect to each Transferred API [***] with respect to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expenseManufacturer agrees as follows:
(a) the Manufacturer shall, within a reasonable time period, but in no event less than thirty (30) days following written request from Genentech (i) physically transfer such technology, including without limitation any and all Manufacturing Documentation (as hereinafter defined), to Genentech or its designee; (ii) disclose to Genentech and its designee(s) the Manufacturing Process; (iii) provide a license to OSI (with the right to sublicense to Genentech) for any Proprietary Information that is required to make available and have made the Product or Starting Materials, as the case may be; and (iv) provide all cooperation and assistance reasonably requested by Genentech to AstraZeneca [***] an extent that will enable Genentech (or its designee(s)) to assume with as little disruption as reasonably possible, the continued manufacture of the Product or Starting Materials, as the case may be. All information transferred pursuant to this Section 15.1(a) shall be deemed to be confidential and shall be treated as if it was “Proprietary Information” in accordance with Section 8; provided that Genentech shall have the right to transfer such information to third party manufacturers solely in connection with the manufacture of the Product or the Starting Materials, as the case may be.
(b) For the purposes of this Agreement, Manufacturing Documentation shall mean all documents and records describing or otherwise related to the Manufacturing Process or any part of the Manufacturing Process, including, without limitation, documents and records consisting of or containing piping and instrumentation diagrams, software logic and descriptions, batch records, standard operating procedures, including, without limitation, standard operating procedures for in-process quality control testing, facility layout schematics, equipment and instrumentation specifications and process trend and variability data as necessary to allow proper equipment validation and transfer of Product or Starting Materials, as the case may be, manufacture to Genentech or its designee(s).
15.2 In the event that, despite Manufacturer having reasonably met all of its obligations under this Agreement, an Assumption Notice (as defined in Section 16.6) is delivered to the Manufacturer, Manufacturer shall comply with the provisions set forth in Section 15.1(a), at OSI’s expense, but only with respect to those items and information necessary for the proper equipment validation and transferring of manufacture of Product or Starting Materials, as the case may be, to Genentech or its designee. For avoidance of doubt, this Agreement shall remain in full force and effect and the Term and termination of this Agreement shall remain subject to Section 12 of this Agreement, notwithstanding the delivery of such Assumption Notice to Manufacturer pursuant to this Section 16.6.
15.3 If this Agreement is terminated by OSI as a copy result of [***] Manufacturer’s breach of its obligations under the Agreement, then Manufacturer shall, within a reasonable time period, but in no event less than thirty (30) days following written request from OSI (i) physically transfer such technology, including without limitation any and all Manufacturing Documentation (as defined in Section 15.1(b)), to OSI or its designee; (ii) disclose to OSI and its designee(s) the Manufacturer’s production process for the manufacture of Product or the Starting Materials, as the case may be (the “Manufacturing Know-HowProcess”);
; (b) cause appropriate employees and representatives of Moderna and its Affiliates and [***] to [***];
(c) take such steps as are [***];
(d) upon AstraZeneca’s request, [***];
(e) upon AstraZeneca’s request, [***]; and
(fiii) provide such other a license to OSI (with the right to sublicense to Genentech) for any Proprietary Information that is required to make and have made the Product or Starting Materials, as the case may be; and (iv) provide all cooperation and assistance as AstraZeneca may reasonably request requested by OSI to an extent that will enable AstraZeneca OSI (or its designee designee(s)) to Manufacture assume with as little disruption as reasonably possible, the Transferred APIs [***] in accordance with continued manufacture of the applicable SpecificationsProduct or the Starting Materials, including [***]as the case may be, pursuant to the conditions reasonably agreed to by the Parties. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth above, [***] in connection with such technology transfer, and AstraZeneca will be [***] in connection with such technology transfer. AstraZeneca and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca All information transferred pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) for so long 15.3 shall be deemed to be confidential and shall be treated as if it elects (subject to the last sentence of this paragraph) and solely was “Proprietary Information” in accordance with Section 8; provided that OSI or Genentech, as the Transaction Agreementscase may be, and will not use any shall have the right to transfer such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following information to third party manufacturers solely in connection with the completion manufacture of the technology transfer for Product or Starting Materials, as the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading to the Triggering Event were rectifiedcase may be.
Appears in 1 contract
Sources: Manufacturing and Supply Agreement (Osi Pharmaceuticals Inc)
Technology Transfer. Promptly after 2.6.1 Subject to Article 7, which covers the occurrence of any Triggering EventCMC/manufacturing process transfer, Moderna will provide written notice thereof to AstraZeneca. After receipt of such notice, or after becoming aware of the occurrence of any Triggering Event, AstraZeneca will notify Moderna by written notice whether the rights and obligations under this Section 4.5 and Section 4.6 will apply to within [[***]; provided] days of the Effective Date, that AstraZeneca may not elect to have the rights Atara shall, and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) shall cause its Affiliates to, [***] and (iii) [***]] deliver to Bayer and / or its designated Affiliate or Sublicensee, in which case [***] will applya mutually agreeable form, unless and until another Triggering Event occurs (the Moderna mRNA API(s) that are the subject copies of all written, graphic or electronic embodiments of the transfer Licensed Technology and related Complete Invention Disclosures as well as all cell therapeutics and other materials pertaining to [[***], ] for Exploiting Licensed Cell Therapeutics and Licensed Products (hereinafter the “Transferred API(s)Materials”). Within , [***] days of a Triggering Event, Moderna will, and will cause its Affiliates and its manufacturers to, [***]. Without limiting ].
2.6.2 Thereafter, on a continuing basis during the generality term of the foregoingthis Agreement, with respect to each Transferred API Atara shall, [***] with respect to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expense:
(a) make available to AstraZeneca [***] a copy of [***] (the “Manufacturing Know-How”);
(b) and shall cause appropriate employees and representatives of Moderna and its Affiliates to, as soon as reasonably practicable disclose and deliver to Bayer and / or its designated Affiliate or Sublicensee, as soon as reasonably practicable, in a mutually agreeable form, copies of all written, graphic or electronic embodiments of all additional Licensed Technology and / or Complete Invention Disclosures and of all Material which comes into existence from time to time, [***] to [***];].
(c) take such steps as are 2.6.3 Without prejudice to the generality of Sections 2.6.1 and 2.6.2, until [[***];
(d) upon AstraZeneca’s request] Atara shall, [[***];
(e) upon AstraZeneca] at the Atara FTE Rate for each additional FTE hour, provide Bayer or its designated Affiliate or Sublicensee with reasonable technical assistance relating to the use of the Licensed Technology for the purposes of transferring the Licensed Technology from Atara to the applicable Bayer Party, for the purposes of the applicable Bayer Party’s requestacquisition of expertise on the practical application of the Licensed Technology or for the provision of assistance to the applicable Bayer Party on issues arising from time to time during any Exploitation of the Licensed Technology, e.g. with respect to [[***]; and
(f) provide such other assistance as AstraZeneca may reasonably request ]. If visits of Atara’s representatives to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] in accordance with facilities of the applicable SpecificationsBayer Party are requested, including [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth aboveAtara shall send appropriate representatives to such facilities, [***] provided that Bayer shall reimburse Atara for its reasonable and verifiable out-of-pocket expenses of travel and accommodation for such representatives that have been pre-approved by Bayer in connection with such technology transfer, and AstraZeneca will be [***] in connection with such technology transfer. AstraZeneca and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) for so long as it elects (subject to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following the completion of the technology transfer for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading to the Triggering Event were rectifiedwriting.
Appears in 1 contract
Sources: Research and Development and License Agreement (Atara Biotherapeutics, Inc.)
Technology Transfer. Promptly Wyeth and Progenics shall, within [*] after [*], establish procedures and a timeline for the occurrence transfer to Progenics and/or its Commercial Partner(s) of any Triggering Eventall [*], Moderna will provide written notice thereof including all [*], relating to AstraZeneca. After receipt of such noticethe Development, or after becoming aware manufacture and/or Commercialization of the occurrence Products or the Compound ( including [*] created in the course of the Collaboration) in Wyeth’s Control, which procedures and timeline shall be documented in the Termination Transition Plan. To the extent not previously provided to Progenics, Wyeth shall, at no cost to Progenics, transfer to Progenics and/or its Commercial Partner(s) [*] ([*], as applicable) of all such [*] (including [*]) (collectively, “Transition Materials”) in accordance with the agreed-upon timeline set forth in the Termination Transition Plan. With each transfer of [*] Transition Materials set forth in the Termination Transition Plan, Wyeth shall confirm [*], and within [*] of receiving such confirmation, Progenics shall notify Wyeth in writing [*]. Wyeth shall not be obligated to respond to any Triggering Eventrequest by Progenics for [*] Transition Materials unless such request is received by Wyeth in writing within such [*] period; provided that Progenics [*]. Additionally, AstraZeneca will notify Moderna by written notice whether Wyeth shall, at no cost to Progenics, provide technology transfer assistance to the rights extent reasonably necessary to enable Progenics and/or its Commercial Partner(s) to understand and obligations under utilize the (a) Transition Materials transferred to Progenics and/or its Commercial Partner(s) pursuant to this Section 4.5 5.1 and (b) Wyeth Collaboration Know-How licensed to Progenics pursuant to Section 4.6 will apply to 6.4 of this Termination Agreement, as may be reasonably requested by Progenics by providing [*] to participate in no more than (x) [*] per [*] that shall not be longer than [*] in duration and shall take place at a location in the Area selected by [*], and (y) [*] every [*] that shall not be longer than [*] in duration and shall take place at [*]; provided, however, that AstraZeneca may not elect to have the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) such [*] shall occur during normal business hours and in such a way as to not be disruptive to [*], (ii) [*] and shall provide [*] with an agenda for each such meeting at least [*] in advance of such meeting indicating [*], (iii) [*] may, in its sole discretion, elect to [*] and (iv) Wyeth’s obligation to provide such assistance and consultation shall end on [*]; provided, however, that if Wyeth provides additional Transition Materials after such date, then, prior to [*], in which case Wyeth will make its personnel (to the extent such personnel are knowledgeable about such additional Transition Materials and remain employed by Wyeth) available [***] will apply, unless and until another Triggering Event occurs (the Moderna mRNA API(s) that are the subject of the transfer [***], the “Transferred API(s)”). Within [***] days of a Triggering Event, Moderna will, and will cause its Affiliates and its manufacturers to, [***]. Without limiting At Progenics’ request after such transfer, Wyeth shall destroy all copies of any such Transition Materials that relate exclusively to the generality of the foregoingProducts; provided, with respect to each Transferred API however, that Wyeth may retain [***] with respect to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expense:
(a) make available to AstraZeneca [***] a copy of [***] (the “Manufacturing Know-How”);
(b) cause appropriate employees and representatives of Moderna and its Affiliates and [***] to [***];
(c) take such steps as are [***];
(d) upon AstraZeneca’s request, [***];
(e) upon AstraZeneca’s request, [***]; and
(f) provide such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] any Transition Materials in accordance with the applicable Specifications, including [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except as set forth above, [***] in connection with such technology transfer, and AstraZeneca will be [***] in connection with such technology transfer. AstraZeneca and its Third Party manufacturer may only use the Manufacturing Know-How provided to AstraZeneca pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) for so long as it elects (subject to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following the completion of the technology transfer for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading to the Triggering Event were rectified.12221462_5.DOC
Appears in 1 contract
Sources: Termination and Transition Agreement (Progenics Pharmaceuticals Inc)
Technology Transfer. Promptly after As soon as practicable after, and in any event on or before [***] from, the occurrence Effective Date, (a) ABX and IMMUNOGEN will agree upon a schedule to permit two (2) representatives designated by ABX to visit IMMUNOGEN’s facilities for a period of any Triggering Event, Moderna will provide written notice thereof to AstraZeneca. After receipt of such notice, or after becoming aware of the occurrence of any Triggering Event, AstraZeneca will notify Moderna by written notice whether the rights and obligations under this Section 4.5 and Section 4.6 will apply no more than [***] to [***] to an [***] and to [***] the [***] and [***] used [***]; provided, that AstraZeneca may not elect to have the rights and obligations under this Section 4.5 and Section 4.6 apply to clause (b) under the following circumstances: (i) [***] and (iii) [***], in which case [***] will apply, unless and until another Triggering Event occurs (the Moderna mRNA API(s) that are the subject of the transfer [***], the “Transferred API(s)”). Within [***] days of a Triggering Event, Moderna will, and will cause its Affiliates and its manufacturers to, [***]. Without limiting the generality of the foregoing, with respect to each Transferred API shall [***] with respect to which AstraZeneca requests and is entitled to a technology transfer, Moderna and its Affiliates will, and Moderna will [***], at AstraZeneca’s expense:
(a) make available to AstraZeneca [***] a copy of [***] (the “Manufacturing Know-How”);
(b) cause appropriate employees and representatives of Moderna and its Affiliates and such [***] to [***];
(c) take . During such steps visit, IMMUNOGEN shall deliver to ABX all IMMUNOGEN Background Technology existing as are of the Effective Date. [***];
(d) upon AstraZeneca’s request, [***];
(e) upon AstraZeneca’s request, [***]; and
(f) provide such other assistance as AstraZeneca may reasonably request to enable AstraZeneca or its designee to Manufacture the Transferred APIs [***] in accordance with the applicable Specifications, including shall [***] to [***] and [***]. A&R SERVICES AND COLLABORATION AGREEMENT Except As soon as set forth abovepracticable thereafter, but in any event on or before [***] in connection with such technology transfer, and AstraZeneca will be from [***] of [***], the Parties shall, in connection with such technology transfer. AstraZeneca and its Third Party manufacturer may only use the Manufacturing Know-How provided order to AstraZeneca pursuant to this Section 4.5 in support of Manufacturing the Transferred API(s) for so long as it elects (subject to the last sentence of this paragraph) and solely in accordance with the Transaction Agreements, and will not use any such Manufacturing Know-How for any other reason or for any other product or product candidate (or intermediate or component thereof). [***] Following attached hereto and [***], and the completion [***] between the [***], if any. The initial technology transfer under this Section 2.6 shall be complete for purposes of Section 4.1 at such time as [***]. Promptly, but not less than quarterly thereafter, IMMUNOGEN shall deliver to ABX all IMMUNOGEN Background Technology not previously delivered to ABX. From time to time during the Research Term, IMMUNOGEN shall provide ABX with such technical assistance as reasonably requested by ABX regarding the use of the technology transfer IMMUNOGEN Background Technology. Such technical assistance and expertise shall include, but not be limited to, visits by IMMUNOGEN personnel to ABX and visits by ABX personnel to IMMUNOGEN, at ABX’s expense, at such times and for the Transferred API(s), AstraZeneca will notify Moderna regarding whether, for how long and to what extent it would expect to continue to purchase the Transferred API(s) from Moderna if problems leading such periods of time as may be reasonably acceptable to the Triggering Event were rectifiedParties. Additionally, at the reasonable request of ABX, IMMUNOGEN shall transfer all applicable IMMUNOGEN Background Technology, and provide such technical assistance, to such Third Party collaborator, sublicensee or contract manufacturer as ABX designates.
Appears in 1 contract