Common use of Manufacturing Technology Transfer Clause in Contracts

Manufacturing Technology Transfer. With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

Appears in 4 contracts

Samples: Collaboration and Option Agreement (Morphic Holding, Inc.), Collaboration and Option Agreement (Morphic Holding, Inc.), Collaboration and Option Agreement (Morphic Holding, Inc.)

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Manufacturing Technology Transfer. With Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to each Technology Transfer Productmanufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, upon AbbVie’s written request after methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the Inclusion Date "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the Included Target manufacture of the Products and shall not disclose or transfer such Manufacturing Information to which such Technology Transfer Product is Directedany third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, Morphic shall effect and bear its costs for, up to [ * ] FTEs for a full transfer period of up to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer[ * ] months [ * ] in aggregate) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement accomplish the Manufacturing Process Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities designated by AbbVie (such transfer MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and implementationthat MEGABIOS is able to provide, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***[ * ] FTE hours after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such additional assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

Appears in 2 contracts

Samples: Research and License Agreement (Megabios Corp), Research and License Agreement (Megabios Corp)

Manufacturing Technology Transfer. With respect to each Technology Transfer ProductUpon Allergan’s request, upon AbbVie’s written request initiated no earlier than [*] after the Inclusion Effective Date and no later than the completion of the first Phase II Clinical Trial for the Included Target to which such Technology Transfer a Licensed Product is Directedconducted by Allergan or its authorized designee, Morphic UroGen shall effect a full transfer to AbbVie Allergan or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint UroGen Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product the RTGel Component (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such Allergan. The transfer and implementationof the Manufacturing Process from UroGen shall be deemed complete when Allergan is able to, either itself or via its designee, Manufacture Licensed Products that meet established specifications. Following completion of the transfer of the Manufacturing Process in accordance with this Section 5.2, as more fully described between the Parties, (a) Allergan shall be responsible for securing the manufacture of its future needs of RTGel Components not then subject to an outstanding purchase order including, for the avoidance of doubt, any Phase I or Phase II Clinical Trials conducted by Allergan after the completion of such transfer, and (b) except with respect to purchase orders placed by Allergan in this accordance with Section 5.35.1.1 for RTGel Component prior to the completion of transfer, Section 5.1.1 and Section 5.1.3 shall cease to apply in their entirety. Upon Allergan’s reasonable request following the “Manufacturing Technology Transfer”). To assist with transfer of the Manufacturing Technology TransferProcess for the RTGel Component, Morphic will make its personnel reasonably available to AbbVie during normal business hours for UroGen shall provide (i) up to [**] hours of reasonable technical assistance [*] FTE hours with respect to each Included Target (in each case, free following the transfer of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafterto enable Allergan (or its Affiliate or designated Third Party manufacturer, if as applicable) to implement, use and practice the Manufacturing Process at the facilities designated by Allergan and (ii) such additional technical assistance (including access to its technical personnel) as may be requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic Allergan for its full-time equivalent (FTE) costs (for clarity, in excess compensation at the rate of [***] FTE hoursper hour, in each case of (i) and any reasonable (ii) subject to reimbursement of UroGen’s documented travel and verifiable other out-of-pocket costs expenses incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY assistance within [*] days of invoice therefor. Notwithstanding the anything to the contrary, Allergan shall be responsible at all times during the Term for manufacture of all [**], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED] of the Licensed Product.

Appears in 2 contracts

Samples: License Agreement (UroGen Pharma Ltd.), License Agreement (UroGen Pharma Ltd.)

Manufacturing Technology Transfer. With respect In addition to each Technology Benitec’s obligations under Section 2.4 (Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Materials for BB-301) and Section 3.7 (Transfer of Know- How and Materials for Collaboration Programs), Benitec shall (itself or through its Affiliate(s)) transfer to Axovant or its designee all process development work conducted by Benitec as of the Effective Date or during the Term to the extent that it is reasonably necessary or useful for the manufacture of any of Compound or Licensed Product at any time that such work is completed and ready to be transferred, solely for Axovant or its CMO to manufacture or have manufactured Compounds or Licensed Products in accordance with the terms and conditions of this Agreement. Such transfer shall include copies of the Benitec Know-How relating to the then-current process and any tangible materials that are necessary for the Manufacture implementation of such Technology Transfer Product process development work in manufacture of Compounds or Licensed Products. Upon Axovant’s reasonable request, Benitec shall (the “Manufacturing Process”itself or through its Affiliate(s)) and to implement the Manufacturing Process at facilities designated provide reasonable technical assistance by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its making appropriate personnel reasonably available to AbbVie during normal business hours Axovant at reasonable times, places, and frequency, and upon reasonable prior notice for up to an aggregate of [***] FTE hours with respect to each Included Target (in each case], which shall be free of charge to AbbVie) Axovant, for the purpose of assisting Axovant to transfer understand and implement use such Benitec Know-How for the Manufacturing Process under this Section 5.3manufacture of Compounds and Licensed Products. Thereafter, if requested by AbbVieAxovant, Morphic Benitec shall continue to make its personnel available to Axovant and continue to perform such technology transfer obligations; provided, provided that AbbVie Axovant will reimburse Morphic and pay Benitec for its fulltime incurred in performing such technology transfer obligations and providing such assistance at the Benitec FTE Rate. The following costs and fees for the manufacturing and technology transfer assistance described in this Section 6.2 (Manufacturing Technology Transfer) shall be reimbursed and paid by Axovant pursuant to Section 8.2(b) (Reimbursement of Benitec Manufacturing Technology Transfer Costs): (a) the Out-time equivalent of-Pocket Costs incurred by Benitec or its Affiliate(s), and (FTEb) costs (for clarity, the product of the Benitec FTE Rate multiplied by the number of Benitec FTE hours provided in excess of [***] FTE hours) and any reasonable and verifiable outthe above-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY referenced free [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.in each case of (a) and (b) that are directly related to such technology transfer or assistance (collectively, the “Benitec Technology Transfer Costs”). The Benitec Technology Transfer Costs shall be reimbursed by Axovant in accordance with Section 8.2(b) (Reimbursement of Benitec Manufacturing Technology Transfer Costs). [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

Appears in 1 contract

Samples: License and Collaboration Agreement (Axovant Sciences Ltd.)

Manufacturing Technology Transfer. With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for Effective Date, the Included Target to which such Technology Transfer Product is Directed, Morphic MWG shall effect have convened and developed a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product plan (the “Manufacturing ProcessTechnology Transfer Plan”) for the reasonably prompt transfer by MSB to Collaborator (or if Collaborator requests to a Third Party (reasonably approved by MSB); provided that such Third Party enters into a confidentiality agreement with MSB at least as protective of MSB’s Confidential Information as the provisions of Section 10.1 and provides for use of such Confidential Information solely for the purpose of supplying Product to implement Collaborator and its Affiliates for the Manufacturing Process at facilities designated purposes of this Agreement) of Data, technical information, documents, and materials (including Proprietary Materials in accordance with Section 6.1.3 and information necessary for Collaborator to source or produce the Proprietary Materials if MSB fails to do so), in each case Controlled by AbbVie (such transfer MSB and implementationnecessary for or used by MSB in the Manufacture of Product, as more fully described using MSB’s proprietary MPC manufacturing process in this Section 5.3compliance with the applicable specifications, the “for Development and Commercialization. The Manufacturing Technology Transfer”)Transfer Plan must address the Collaborator’s reasonable technology transfer criteria and requirements as provided to the MWG. To assist with the The Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. ThereafterTransfer Plan shall include, if requested by AbbVieCollaborator, Morphic reasonable and customary on-site support by MSB at the Collaborator’s manufacturing facilities, for which Collaborator agrees to compensate MSB at the rate specified in the Product Memorandum (except no such compensation shall continue be due with respect to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [spent by MSB employees during ***] FTE hours* the implementation of the Manufacturing Technology Transfer Plan) and any reasonable reimburse MSB’s documented and verifiable agreed travel and other out-of-pocket costs expenses incurred in performing providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [support ***]* therefor (which reimbursement shall be in addition to any payments under Section 4.6 and Article 8). MSB shall use Commercially Reasonable Efforts to cause that any Third Party engaged by MSB to assist in the implementation of the transfer contemplated by this Section 6.1.1, HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED****, fully cooperate and assist as required to give full effect to the Manufacturing Technology Transfer Plan. Confidential material omitted and filed separately with the Commission.

Appears in 1 contract

Samples: Development and Commercialization Agreement (Mesoblast LTD)

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Manufacturing Technology Transfer. With respect (i) Notwithstanding anything to each the contrary in this Agreement, from and after the earlier of [**] the occurrence of a Manufacturing Transfer Event (each, a “Technology Transfer ProductEvent”), upon AbbVie’s written Xxxxxx shall be entitled to request after and receive from Surmodics a Technology Transfer, Surmodics shall use Commercially Reasonable Efforts to effect, and to work with Xxxxxx and its Affiliates to effect, such Technology Transfer, and Surmodics shall use Commercially Reasonable Efforts [**] under Applicable Law and in accordance with the Inclusion Date timeline set forth in the implementation plan agreed by the Parties pursuant to Section 4.3.2(iv). Surmodics shall also provide any inputs or components that are needed to conduct the Technology Transfer. In furtherance thereof, within [**] following Xxxxxx’x request for a Technology Transfer, the Parties shall enter into a commercially reasonable supply agreement for the Included Target supply [**], and such raw materials, coating reagents, and components as are reasonably requested by Xxxxxx and are reasonably necessary in order for Xxxxxx to which such Manufacture the Product (the “Supplied Materials”), [**]. As part of the Technology Transfer Product is DirectedTransfer, Morphic Surmodics shall effect a full transfer to AbbVie Xxxxxx or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic the applicable Surmodics Know-How regarding [**], and Joint the assembly of the raw materials, components and coatings comprising the Product into the Product, all as described in the Technology Transfer and any other Surmodics Know-How relating that is CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. reasonably necessary to Manufacture the Product (except for any Surmodics Know-How for the manufacture of Supplied Materials, to the then-current process for the Manufacture of extent such Technology Transfer Product Supplied Materials are actually supplied by Surmodics to Xxxxxx pursuant to a supply agreement entered into pursuant to this Section 4.3.2(i)) (the “Manufacturing Process”) ), and shall provide such support as reasonably necessary to implement Xxxxxx or its Affiliate, as applicable, to use and practice the Manufacturing Process at facilities designated for the Product, including by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect ]. Xxxxxx shall have the right to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform order Product from Surmodics hereunder after any such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSEDTechnology Transfer.

Appears in 1 contract

Samples: Development and Distribution Agreement (Surmodics Inc)

Manufacturing Technology Transfer. With respect to each Technology Transfer ProductWithout limiting the generality of the obligations in Section 4.3, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic [**] Xilio shall effect a full transfer to AbbVie Gilead or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Licensed Know-How relating to the Manufacture of the IL-12 Molecules and the IL-12 Products and all intermediates and components thereof, including the then-current process for the Manufacture of such Technology Transfer Product the IL-12 Molecules and IL-12 Products (the “Manufacturing Process”) ), and provide such support as may be necessary or useful to implement Gilead or its designee to use and practice the Manufacturing Process at facilities designated Process, including by AbbVie assisting Gilead or its designee to enter into agreements with any of Xilio’s Third Party manufacturers (such transfer and implementationsupport, as more fully described in this Section 5.36.4, the “Manufacturing Technology Transfer”). To assist The Manufacturing Technology Transfer shall be sufficient to enable Gilead or such designee to perform the then-current Manufacturing Process and Manufacture the IL-12 Molecules and IL-12 Products. [**] the JSC shall develop and, subject to Section 2.1.3(b)(ii), approve a written plan to operationalize the Manufacturing Technology Transfer obligations of the Parties set forth in this Section 6.4 (the “Manufacturing Transition Plan”), which plan will include a detailed budget of the FTE Costs and Out-of-Pocket Costs expected to be incurred in the performance of the activities set forth in the such Manufacturing Transition Plan; provided that [**]. The Parties shall perform each activity allocated to such Party under the Manufacturing Transition ​ Plan and shall use Commercially Reasonable Efforts to implement the Manufacturing Technology Transfer to Gilead or its designee in accordance with the Manufacturing Transition Plan. Each Party shall be initially responsible for its costs incurred in connection with performing each Manufacturing Technology Transfer and Gilead shall reimburse Xilio for its reasonable and verifiable FTE Costs and Out-of-Pocket Costs incurred in connection with the assistance provided under this Section 6.4 in accordance with Section 6.5. Without limitation to the foregoing, in connection with each Manufacturing Technology Transfer, Morphic will make Xilio shall provide, and shall use commercially reasonable efforts to cause its personnel Third Party manufacturers to provide, such other assistance as Gilead (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably available request to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target enable Gilead (in each caseor its Affiliate or designated Third Party manufacturer, free of charge to AbbVieas applicable) to transfer use and implement practice the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue and otherwise to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) Manufacture IL-12 Molecules and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSEDIL-12 Products.

Appears in 1 contract

Samples: License Agreement (Xilio Therapeutics, Inc.)

Manufacturing Technology Transfer. With On a Program-by-Program basis, [***] (a) with respect to each Technology Transfer Productthe CD123 Development Program, upon AbbVie’s written request after the Inclusion CD123 Option Effective Date and (b) with respect to a Research Program, the Research Program Opt-In Effective Date for the Included Target such Research Program, MacroGenics will work with Gilead to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie Gilead (or its designee (which designee may be an Affiliate or a Third Party manufacturerdesignee) of all Morphic MacroGenics Licensed Know-How [***] for the applicable Program, to the extent not previously transferred to Gilead under this Agreement, including by providing copies or samples of relevant documentation, materials, and Joint other embodiments of any such MacroGenics Licensed Know-How, and by making available its qualified technical personnel on a reasonable basis to consult with Gilead with respect to such Know-How relating to the then-current process (for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementationeach Program, as more fully described in this Section 5.3, the a “Manufacturing Technology Transfer”). To assist with the Each Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to Transfer [***] FTE hours Manufacturing Processes and Manufacture the applicable Licensed Product, and shall be subject to a written plan developed and approved by the Parties through the JSC in good faith with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3Technology Transfer (the “Manufacturing Transition Plan”). Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of Each Manufacturing Transition Plan [***] FTE hoursperformance of the activities set forth in the applicable Manufacturing Transition Plan (each, a “Manufacturing Transition Budget”). The Parties shall use Commercially Reasonable Efforts to implement each Manufacturing Technology Transfer to Gilead or its designee in accordance with the applicable Manufacturing Transition Plan. [***] Manufacturing Technology Transfer for the relevant Program(s). [***] MacroGenics to conduct activities under the Manufacturing Transition Plan for such Program(s) in accordance [***] MacroGenics shall provide notice to the JSC and the JSC shall promptly discuss in good faith and consider whether to implement any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY amendments to the Manufacturing Transition Plan [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

Appears in 1 contract

Samples: Collaboration and License Agreement (Macrogenics Inc)

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