Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.

Manufacturing Technology Transfer. Except At Everest’s request made at any time following completion of patient enrollment of the Palizade Trial in the Territory, the Parties shall discuss in good faith through the JSC and agree to a written technology transfer plan within [***] after commencement of such discussion, under which Xxxxx or its CMO shall transfer to Everest (or a CMO designated by Everest and approved by Xxxxx) all Manufacturing Know-How within the agreed timelines (not to exceed [***] after agreement on such technology transfer plan). Xxxxx shall use Commercially Reasonable Efforts to, by itself or cause its CMO to, complete such technology transfer within the timelines set forth in the agreed technology transfer plan. Upon reasonable request from Xxxxxxx, Xxxxx will provide Everest with all reasonable assistance at the FTE Rate to review and discuss the Manufacturing Know-How for Everest to Manufacture the Compound and the Product in substantially the same manner as Xxxxx, its Affiliate or a CMO that has been engaged to Manufacture and supply the Product on Xxxxx’x behalf. Prior to engaging a CMO for the technology transfer, Everest shall enter into an agreement with such CMO that contains customary provisions related to confidentiality and retention of intellectual property relating to the Product and its Manufacturing process, which shall be consistent with the provisions in this Agreement, and will provide a copy of such CMO agreement and the associated quality agreement to Xxxxx upon request, provided that Everest may [***]. Xxxxx shall have the right to audit any CMO that is Manufacturing the Product in Section 4.3(f)(iii)(1the Territory. Everest shall reimburse all internal (at the FTE Rate) and Third Party expenses that Xxxxx incurs to conduct its activities under this Section 6.108.3 (Manufacturing Technology Transfer), with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if within [***] after receipt of each invoice therefor from Xxxxx. In the event that (a) Cue does not elect for LGC Everest has the right to perform CMC Step 2, CMC Step 3, or CMC Step 4 terminate this Agreement under Section 13.3 (or with respect to LGC Reserved Products, upon completion of CMC Step 1Termination Upon Bankruptcy), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, thenSection 13.9.2 applies, in each case (a) or (b), (i) Everest shall have the right to enter into its own separate direct agreements with any Third Parties or CMOs that have been engaged to Manufacture and supply the Product on Xxxxx’x behalf, and (ii) upon the written request of CueEverest’s request, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and Xxxxx will facilitate Everest’s entry into direct agreements with such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (Third Party or LGC Reserved ProductCMO, including the LGC Reserved Compound therein, if applicable) by consent to use the Manufacturing Know-How as reasonable and necessary to permit Everest to Manufacture directly with such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate Third Party or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.

Manufacturing Technology Transfer. Except as provided in In order to enable Pfizer to Manufacture or have Manufactured the Compound and Licensed Products consistent with the terms of Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product 6.1 (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved ProductsManufacturing Responsibilities), upon completion a written request from Pfizer, during a mutually agreed time period of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within no more than [***] days (providedthe “Manufacturing Transfer Period XE "Manufacturing Transfer Period" \t "See 6.2" ”), Sxxxx shall (a) make available and transfer to Pfizer, copies of existing embodiments of the Licensed Know-How in Sxxxx’x Control and possession that if such breach is not are necessary or reasonably capable useful in the Manufacture of cure within such [***] day period, then such cure period shall be automatically extended the Compound and Licensed Products (the “Licensed Manufacturing Know-How XE "Licensed Manufacturing Know-How" \t "See 6.2" ”) solely for an additional [***] day period as long as LGC continues Pfizer and/or its Subcontractor to use diligent efforts to cure such breach Manufacture the Compound and Licensed Products in accordance with the terms and conditions of this Agreement; (b) identify in writing any Sxxxx CMO; and (c) provide technical assistance (both on site and otherwise) in the transfer and demonstration of the Licensed Manufacturing Know-How. To the extent that any Licensed Manufacturing Know-How is in the Control of Sxxxx but is in the possession of a reasonable cure plan Sxxxx CMO (and if such breach is not reasonably capable of cure within such combined [***] day periodin Sxxxx’x possession), then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan)during the Manufacturing Transfer Period, as applicableupon Pfizer’s request, then, in each case upon the written request of Cue, LGC shall Sxxxx will use Commercially Reasonable Efforts to facilitate the transfer of such Licensed Manufacturing Know-How from such Sxxxx CMO to Pfizer, and/or cause such Sxxxx CMO to make a technology such Licensed Manufacturing Know-How available to Pfizer. Pfizer, in its sole discretion and at its sole expense, may contract with any such Sxxxx CMO for technical assistance (both on site and otherwise) in the transfer to an Approved CMO and demonstration of the Licensed Manufacturing processes (including materials and such other information) but solely as Know-How that is necessary to enable Manufacture the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Licensed Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved ProductsManufacturing Transfer Period, if applicable)requested by Pfizer, if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue Sxxxx will in good faith endeavor to provide support additional technical assistance in the transfer of Licensed Manufacturing Know-How to Cue Pfizer; provided that Pfizer shall be responsible for up to an additional [***] period for up to [***] hours the costs and expenses of Sxxxx’x technical assistance following the Manufacturing Transfer Period and shall pay or reimburse Sxxxx at the FTE Reimbursement Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything following a written invoice in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMOreasonable detail.

Manufacturing Technology Transfer. Except as provided In addition to the initial technology transfer set forth in Section 4.3(f)(iii)(12.5 (Knowledge and Technology Transfer), upon Takeda’s election to assume Manufacturing responsibility pursuant to Section 6.1.6 (Takeda’s Assumption of Manufacturing Responsibility), Arrowhead will work with Takeda to transfer to Takeda (a) all Arrowhead Know-How that is necessary or that has been identified by either Party as reasonably useful to enable the Manufacture of the Compounds and Section 6.10Products, to the extent not previously transferred to Takeda under this Agreement, by providing copies or samples of relevant documentation, materials, and other embodiments of any such Arrowhead Know-How, and by making available its qualified technical personnel on a reasonable basis to consult with Takeda with respect to any Collaboration Product (or LGC Reserved Productsuch Know-How, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or and (b) upon failure subject to the conditions in this Section 6.4 (Manufacturing Technology Transfer), any materials (as well as any intermediates and impurities of the Parties to reach agreement with respect to a Clinical Supply Agreement such materials) used by Arrowhead or a Commercial Supply Agreement or (c) its [***] under this Agreement = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. Affiliates or Subcontractors in the Manufacture of such Product (the “Manufacturing Technology Transfer”). The Manufacturing Technology Transfer will be conducted pursuant to and does not cure such breach within will be subject to a written plan developed and agreed by the Parties in good faith at least [***] days (providedprior to the anticipated commencement of the Manufacturing Technology Transfer, that if such breach is not reasonably capable the purpose of cure within such [***] day period, then such cure period shall which plan will be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan carry out the complete and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension timely transfer of such cure period as long as LGC continues to use diligent efforts to cure such breach Arrowhead Know-How in accordance a manner that is consistent with a then-current reasonable cure plan), as applicable, theninternal technology transfer corporate standards (or equivalent policy) of Takeda. Without limiting the foregoing, in each case upon connection with the written request development of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary Technology Transfer plan, Arrowhead will identify to enable Takeda any Third Party intellectual property used by Arrowhead in the Manufacture of the Products that may contain restrictions or conditions applicable to the use thereof by or on behalf of Takeda. If requested by Takeda, Arrowhead will use reasonable efforts to facilitate Takeda’s access to or right to use or have used any such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMOintellectual property.